ML23152A217

PR-020 - 63FR38511 - Respiratory Protection and Controls to Restrict Internal Exposures

ML23152A217
Person / Time
Issue date:	07/17/1998
From:	NRC/SECY
To:
References
PR-020, 63FR38511
Download: ML23152A217 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 07/17/1998 TITLE: PR-020 - 63FR38511 - RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES CASE

REFERENCE:

PR-020 63FR38511 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-020 OPEN ITEM (Y/N) N RULE NAME: RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES PROPOSED RULE FED REG CITE: 63FR38511 PROPOSED RULE PUBLICATION DATE: 07/17/98 NUMBER OF COMMENTS: 19 ORIGINAL DATE FOR COMMENTS: 09/30/98 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 64FRS4543 FINAL RULE PUBLICATION DATE: 10/07/99 NOTES ON:

STATUS OF RULE :

HISTORY OF THE RULE PART AFFECTED: PR-020 RULE TITLE: RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 98-077 SRM DATE: I I SIGNED BY SECRETARY: 07/13/98 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: 99-207 SRM DATE: 09/10/99 SIGNED BY SECRETARY: 09/30/99 STAFF CONTACTS ON THE RULE CONTACTl: ALAN K. ROECKLEIN MAIL STOP: O-l0HS PHONE: 415-3883 CONTACT2: MAIL STOP: PHONE:

DOCKET NO. PR-020 (63FR38511)

In the Matter of RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 07/14/98 07/13/98 FEDERAL REGISTER NOTICE - PROPOSED RULE 08/21/98 08/17/98 COMMENT OF INTEGRATED ENVIRONMENTAL MANAGEMENT, INC.

(CAROL D. BERGER, PRESIDENT, ET AL.) ( 1) 08/31/98 08/19/98 COMMENT OF DOC - NATIONAL INSTITUTE OF STANDARDS &TECHNOLOGY (LESTER A. SLABACK, JR.) ( 2) 09/15/98 09/10/98 COMMENT OF BWX TECHNOLOGIES, INC. (ARNE F. OLSEN) ( 3) 09/16/98 09/14/98 COMMENT OF CHING-TSEN BIEN ( 4) 09/22/98 09/21/98 COMMENT OF MINNESOTA MINING AND MANUFACTURING COMPANY (3M)

(RONALD E. KING) ( 5) 09/23/98 09/21/98 COMMENT OF OSRAM SYLVANIA PRODUCTS, INC.

(CARMEN VENEZIA) ( 6) 09/28/98 09/22/98 COMMENT OF WYOMING MINING ASSOCIATION (MARION LOOMIS, EXECUTIVE DIRECTOR) ( 7) 09/29/98 09/28/98 COMMENT OF NAT L INSTITUTE FOR OCCUPATIONAL SAFETY &HEALTH 1

(PAUL A. SCHULTE, PH.D., DIR., EID) ( 8) 09/29/98 09/28/98 COMMENT OF DANIEL J. STROM, PH.D. ( 9) 09/30/98 09/30/98 COMMENT OF MICHAEL J. BENJAMIN ( 10) 10/01/98 09/30/98 COMMENT OF MALLINCKRODT, INC. (ASHOK K. DHAR) ( 11) 10/05/98 09/30/98 COMMENT OF VIRGINIA POWER (JAMES H. MCCARTHY) ( 12) 10/05/98 10/01/98 COMMENT OF COMMONWEALTH EDISON COMPANY (R. M. KRICH, VP, REG. SERVICES) ( 13) 10/08/98 09/30/98 COMMENT OF TSI INCORPORATED (JEFF WEED) ( 14) 10/09/98 10/05/98 COMMENT OF ISEA, THE SAFETY EQUIPMENT ASSOCIATION (JANICE COMER BRADLEY) ( 15)

DOCKET NO. PR-020 (63FR38511)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 10/19/98 10/09/98 COMMENT OF NUCLEAR ENERGY INSTITUTE (LYNNETTE HENDRICKS) ( 16) 10/28/98 10/22/98 COMMENT OF JOHN P. HALE ( 17) 02/05/99 01/29/99 COMMENT OF DEPARTMENT OF ENERGY (JOSEPH E. FITZGERALD, JR.) ( 18) 09/30/99 09/30/99 FEDERAL REGISTER NOTICE - FINAL RULE 11/16/99 11/09/99 COMMENT OF U.S. DEPARTMENT OF COMMERCE/NIST (LESTER A. SLABACK, JR.) ( 19)

UNITED STATES DEPARTMENT DF COMMERCE NISr National ln tltute of Stendarde and Technology Ga1tt1ersburg, Mar y la nd 208 9 9 DOCKET us DOCKET NUMBER PROPOSED RULE PR o2o "99 NO' 16 P3 :S6

( <,3FR 3B'511) 9 November 1999 C

AD..1 Office of the Secretary of the Commission Nuclear Regulatory Commission Washington, D.C. 20555-0001 Ref: RIN 3150-AF81 (64FR54543, 10CFR20 Subpart H)

In reading the recently revised version of 10CFR20 Subpart H and the associated statement of considerations, I believe I have identified a number of areas that require additional guidance and clarification by the Nuclear Regulatory Commission (NRC). First, please clarify the intent of the applicability of the revision to 10CFR20 Subpart H (Respiratory Protection) for licensees who use respirators where exposures to licensed material are essentially incidental, i.e., are at levels less than the Airborne Radioactivity Area criterion and with exposures of a small fraction of an ALI. My concern is that the final rule is silent on this issue, that the Statements o Consideration are ambiguous in this regard, and that the Regulatory GJi,ide conflicts with what might be (and what I hope is) the intended interpretation of tlre rule.

The issue in this regard is that the vast majority of materials and non-power reactor licensees have no need for a 20.1703 program based on potential exposures, and that their OSHA compliant programs are adequate for personnel safety for any use of respirators. Irrespective of that, on 64FR54544 NRC specifies that it has jurisdiction and thl t 20.1703 rules apply (with no qualification or exceptions stated), which results in duplicate and redundant respiratory protection programs for most licensees (as discussed in our previous submission on the proposed rule).

A number of statements are made that relate to this issue. On 64FR54545 it states" ... 20.1703 come into effect if the licensee assigns or permits the use of respiratory protection equipment to limit the intake ofradioactive material. ... If the licensee determines that respiratory protection is not required to limit intake of radioactive material and a respirator is used for some other reason, then the 20.1703 condi *ons are not applicable." Further, Regulatory Guide 8.15 states

" ... 20.1703 requires a minimum respiratory program ... , even if the licensee does not intend to take credit for the protection provided y the respirators in estimating intakes," and" .. . NRC considers a respiratory protection device is being used to limit intakes of airborne radioactive ,.

materials unless the device is clearly and exclusively used for protection against non-radiological hazards."

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But on 64FR54550 it states that "If analysis shows that respiratory protection would not have been required in order to limit intake of radioactive material, then compliance with Subpart H would not be required," implying that usage does not really need to be exclusionary. Further, on 64FR54550, the example interpretation of the meaning of the phrase limit intake allows incidental exposure to radioactive materials when respirators are used for non-radiological reasons.

The conflicting or ambiguous issues raised by these statements:

1. The use of assign or permit to trigger a application of20.l 703, regardless of the underlying reasons for usage and regardless of the level of exposure;

2. Reference to not required to limit intake where the only requirements are the Part 20 limits and the ALARA program, which are always applicable, resuiting in a null statement (unless no radioactive material is present);

3. Excluding " ... not taking credit ... " as a basis for exclusion of 20.1703, when in fact for very low exposure potentials that is the common reality of the workplace and an expression of ALARA;

4. The" ... clearly and exclusively ... " phraseology of Reg. Guide 8.15 which clearly is inconsistent with the definition oflimiting intake in 64FR54550;

5. The definition of limit intake, which appears in the Statements of Consideration and does not appear in the Reg. Guide, results in a very black-and-white interpretation of the words in that guide, inconsistent with the Statements of Consideration;

6. Intermittent or occasional use of a respirator in environments of less than Airborne Radioactivity Area levels, i.e., less than 2.5 mrem/hr, by definition results in exposures less than 10% of the regulatory limits and hence (in general) are not subject to individual monitoring requirements (20.1502), but simply putting on a respirator precipitates such requirements (20.1703(c)). As an aside, if the regulatory analysis and justification of20.1502 was acceptable then it would appear that 20.1703 is an unneeded and excessive requirement in these exposure circumstances.

With the above preamble I ask: If a licensee, in an environment of less than Airborne Radioactivity Area levels and with projected annual dose commitments of less than 10% of the regulatory limit, chooses to use any type of respirator within the auspices of an OSHA compliant program for any reason other than controlling radiological exposure, i.e., limiting intake, is that licensee subject to 20.1703? If the NRC answer is yes, then under what exposure and usage conditions would the licensee not be subject to 20.1703?

A second question: If a licensee commits to the use of an OSHA compliant program, i.e., using the OSHA compliant respiratory protection program that already exists in most large organizations, would the NRC accept this in lieu of a 20.1703 program for any use of a respirator

(including to limit intakes) where the exposure conditions are less than Airborne Radioactivity Area levels and where work without respiratory protection would have projected annual dose commitment of less than 10% of the regulatory limit?

Regarding this second question, we recognize that the involvement of NRC licensed material makes NRC the controlling regulatory agency in this circumstance. However, when no respiratory protection is an acceptable option, it would seem that the only NRC interest is worker safety, in which case commitment to an OSHA program would seem to be equivalent and avoids duplicate programs. Note that even if the regulatory rules are identical, programs mandated by two different regulatory agencies as a practical fact result in two separate programs to implement those two sets of rules, because different organizational elements deal with those different agencies. Hence, mandating the applicability of 20.1703 in the above circumstances results in redundant programs. Consequently, allowance by NRC to use the existing organizational OSHA program would result in a reduction in federally mandated programs without any reduction in worker safety.

Also note, regarding the question above, that Section 6.8 of Regulatory Guide 8.15 does not provide this relief. It basically is intended to relieve the licensee of having an OSHA program if the licensee has a 20.1703 program but does nothing for those that already have the OSHA program. Furthermore, the statement, "The NRC requirements ... are not likely to place any significant burden on licensees," ignores the reality of a dual regulatory environment in which dual regulation frequently results in redundant programs (for very real and valid organizational concerns).

I would appreciate your response to these issues and, if a clarification of the rule or regulatory guide is necessary, what the projected schedule for completion for this would be.

Sincerely,

}&)f/$4/

Lester A. Slaback, Jr.

Supervisory Health Physicist National Institute of Standards and Technology 100 Bureau Dr. STOP 3543 Gaithersburg, MD 20899-3543 cc: Alan Roecklein Cynthia Carpenter David Matthews nrcl 1-8-99.doc

DOCKET NUMBER ooc* -c_:o PROPOSED AUL u~ [7590-01-P]

• 99 SE.n 30 p 2 :c2 o.

NUCLEAR REGULATORY COMMISSIO~L 10 CFR Part 20 RIN 3150-AF81 Respiratory Protection and Controls to Restrict Internal Exposures AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulations regarding the use of respiratory protection and other controls to restrict intake of radioactive material. The amendments make these regulations more consistent with the philosophy of controlling the sum

• of internal and external radiation exposure, reflect current guidance on respiratory protection from the American National Standards Institute (ANSI), are consistent with recently effective revisions to Occupational Safety and Health Administration (OSHA's) respiratory protection rule, and make NRC requirements for radiological protection less prescriptive while reducing unnecessary regulatory burden without reducing worker protection. The amendments provide greater assurance that worker dose will be maintained as low as is reasonably achievable (ALARA) and that recent technological advances in respiratory protection equipment and procedures are reflected in NRC regulations and clearly approved for use by licensees.

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i 1~ J./1 :2000 I EFFECTIVE DATE: (II ,sert elate 128 ele:ys f,e111 date ef rm6"1ieat1rn ~ir,. FR).

FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-3883; email AKR@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background The NRG published a major revision of 10 CFR Part 20, "Standards for Protection Against Radiation," on May 21, 1991 (56 FR 23360). Although the NRG was aware that certain provisions of Subpart H and Appendix A to Part 20 were out of date and did not reflect new technology in respiratory devices and procedures, the NRG made minimal changes in the May 21, 1991 final rule. The NRG was aware that an ANSI standard was being prepared that was expected to provide state-of-the-art guidance on acceptable respiratory protection devices

• and procedures. Therefore, the NRG decided to address further revisions to Subpart H and Appendix A to Part 20 when the ANSI guidance was complete.

In response to public comments on the proposed 10 CFR Part 20, the NRG made several changes to Subpart H in the May 21, 1991, final rule to make it consistent with the new philosophy and science underlying the new Part 20. The new Subpart H required that the practice of ALARA apply to the sum of internal and external dose; addressed correction of both high and low initial intake estimates if subsequent, more accurate measurements gave different results; and clarified that a respiratory protection program consistent with Subpart H is required whenever respirators are used to limit intakes of radioactive material.

2

After 10 CFR Part 20 was revised, the American National Standards Institute approved publication of ANSI Z88.2-1992, "American National Standard for Respiratory Protection". This document provides an authoritative consensus on major elements of an acceptable respiratory protection program, including guidance on respirator selection, training, fit testing, and assigned protection factors (APF). The NRG is amending Subpart H of Part 20 to make the regulations less prescriptive without reducing worker protection. T~is rule is consistent with the 1992 ANSI guidance and is consistent with new regulations on respiratory protection published by the Occupational Safety and Health Administration (OSHA) .

• II. Analysis of Public Comments and Staff Response The proposed rule was published for public comment in the Federal Register July 17, 1998 (63 FR 38511 ). By mid-November seventeen letters had been received from the public providing comments on the rule. One letter was received from an Agreement State and eight letter~ provided comments on the draft revision to Regulatory Guide 8.15.

This section discusses the comments received, how the NRG staff was able to

• incorporate many of the comments into the final rule, and if not, why a comment was not acc~pted. Numerous suggestions for changes were acceptable to the NRG staff consistent with maintaining a comprehensive set of regulations for the use of respiratory protection against airborne radioactive materials, adequate to assure health and safety of workers at NRG-licensed facilities. Every effort was made to retain the burden reduction provided by the amendments in the proposed rule and to comply with the Commission's intent that regulations be risk informed and performance based. Because many commenters addressed the same issues, this analysis will address all comments but specific commenters will not be identified.

3

Several commenters suggested endorsing the regulations on respirator use published re*cently by the Department of Labor, Occupational Safety and Health Administration (OSHA),

29 CFR Parts 191 O and 1926. The proposed NRG regulations were in most respects

- consistent with those adopted by OSHA. Because OSHA's, as well as NRC's, regulations on respirator use may be applicable to facilities that have both radiological and non-radiological hazards, additional changes have been made to the NRG rule to make it even more consistent with OSHA requirements. However, the suggestion to rely entirely on the published OSHA rules is not possible for the following reasons.

The Atomic Energy Act (AEA) gives the NRG the statutory responsibility to protect public health and safety, which includes worker radiological health and safety, in the use of source, byproduct, and special nuclear materials. The Occupational Safety and Health Act (OSH) Act provides that for working conditions where another Federal agency exercises statutory authority to protect worker health and safety, the OSH Act is inapplicable. Therefore in implementing its statutory authority, the NRG preempts the application of the OSH Act for those working conditions involving radioactive materials.

In* 1988, the NRG and OSHA signed a Memorandum of Understanding (MOU) to make jurisdictional responsibilities at NRG licensed facilities clear. Three areas of interest are intended to be regulated by the NRG. These are:

Radiation risk produced by radioactive materials.

Chemical risk produced by radioactive materials.

Plarit conditions that affect the safety of radioactive materials and thus present an increased radiation risk to workers.

The NRG cannot meet its responsibility to protect worker and public radiological safety in these areas without a comprehensive body of regulations to guide inspection and enforcement of essential safety issues specifically addressing radiological hazards.

4

In addition, the NRC regulation includes the Assigned Protection Factors (APFs) recommended by the American National Standards Institute (ANSI) with some modifications.

Because, in radiological applications, using APFs to generate an estimate of intake of

---radioactive materials is an acceptable method to demonstrate compliance with NRC dose limits, APFs must be included in the regulation. However, OSHA rules do not specify APFs because this section-of the OSHA rules is still under development.

The NRC regulations include dose limitation for radiation exposure with the concept of keeping total dose As Low As Is Reasonably Achievable (ALARA). OSHA does not address radiation hazards and does not include the ALARA concept.

Finally NRC requirements do make it clear that if an NRC licensee is using respiratory protection to protect workers against non-radiological hazards, the OSHA requirements apply.

If the NRC has jurisdiction and is responsible for inspection, the MOU specifies that NRC will inform the licensee and OSHA if the NRC observes an unsafe condition relative to non-radiological hazards. For all of these reasons, NRC believes it must have respiratory protection regulations in place, rather than adopt on OSHA regulations.

Several commenters suggested endorsing ANSI guidance in the regulations such as ANSI 288.2-1992, "American National Standard for Respiratory Protection." The ANSI standards are viewed by the NRC staff as comprehensive guidelines that if implemented would contribute to an acceptable program. The NRC staff participated in development of the standards. However, the ANSI standard does not specifically address radiological protection.

In addition, the ANSI recommendations for general respirator usage are too prescriptive to be incorporated as regulatory requirements given the Commission's intent to promulgate risk-informed and performance-based rules.

With changes to the proposed rule discussed here, 10 CFR Part 20, Subpart H will be

• consistent in almost all respects with ANSI guidance. The final Regulatory Guide 8.15, 5

"Acceptable Programs for Respiratory Protection", will endorse, with some minor exceptions, ANSI 288.2, 1992, as providing useful guidance for implementing an acceptable respiratory protection program. This is considered by the NRC to be consistent with the National Technology Transfer and Advancement Act of 1995.

Several commenters objected to the NRC proposed change that fit tests could be performed every three years, instead of annually, with supervisory attention to any physiological changes that might suggest more frequent tests. The commenters observed that the NRC proposal was inconsistent with ANSI guidance and the OSHA requirement for annual fit testing .

. The OSHA requirement for annual fit testing is based on several research studies that showed significant numbers of workers failing to maintain an acceptable level of fit after only 1 year.

The NRC staff agrees and has retained the requirement for annual fit testing in the final rule.

Several commenters suggested that disposable respirators (filtering facepieces or dust masks) without elastomeric sealing surfaces and adjustable straps, should have an APF equal to 1O listed in Appendix A to be consistent with ANSI. The final rule does not assign an APF to "filtering facepieces" that are not equipped with elastomeric face seals and at least two adjustable straps, unless the licensee can demonstrate a fit factor of at least 100 by use of a

• quantitative or qualitative, and validated or evaluated fit testing protocol. If the device can be fit tested to demonstrate a fit factor of at least 100 then an APF of 1O may be used. Although stated differently, this is essentially the condition that ANSI would require of disposables. The NRC rule has the benefit of calling attention to the possibility that some devices, such as dust masks, may not retain good fit under conditions of use in the work place. This provision also permits the use of dust masks and other disposables, if requested by a worker, without the requirement to perform medical exams or fit tests. Fit testing is only required if an APF is assigned, or if credit is taken for use of the device in estimating intake or dose, suggesting that the intent is to limit intake of radioactive material.

6

Three respirator types operating in demand or in demand,* recirculating mode were given APFs of 5 in the proposed rule. This was in an effort to discourage their use by mistake in high concentration areas. ANSI gives these devices APFs equal to 100. Consistent with ANSI and in response to public comment, the NRC staff has changed these APFs to 100.

It was suggested that Appendix A could be put into Regulatory Guide 8.15 so that changes could be made more easily as ANSI revised APFs. This suggestion is not accepted by the NRC staff because APFs may be used to generate estimates of dose of record from the intake of radioactive material and as such should be regulatory requirements. Regulatory Guides provide descriptions of acceptable programs, are guidance only, and cannot be

• enforced unless a licensee commits to use specific regulatory guides in its license. Although many materials licensees and some nuclear power plant licensees do commit to use specific regulatory guidance, thus making the guidance enforceable, it is not required that all licensees incorporate regulatory guides.

In addition, AFPs, as established by ANSI, are considered to be the maximum allowable measure of protection associated with each respirator type and mode of operation. These measures are used to select a licensee's inventory of available respiratory protection devices as well as to select respirators for a particular job. The NRC believes it is important to worker safety that APFs not be flexible as they might be if they were contained only in regulatory guidance.

During the information collection phase of this rulemaking, the NRC staff was advised by several licensees that they would hesitate to use a device unless it were specifically "permitted" in the NRC regulations. Appendix A is needed in the regulation to specify those respiratory devices that are permitted to be used in an NRC licensed facility. For example, quarter facepieces although approved by NIOSH and ANSI, are not permitted for use in NRC licensed 7

facilities. On the other hand, air-supplied suits, that are not tested or certified by NIOSH or listed in ANSI, are in Appendix A to Part 20 thus permitting their use by licensees.

Several commenters suggested that the NRG terms and definitions should be consistent

• with those used by OSHA. The NRG staff agrees. Several OSHA terms and definitions have been added to 1O GFR Part 20 in this final rule and several proposed NRG definitions have been amended to be more consistent with OSHA terms.

A commenter observed that§ 20.1703(c)(3) requires that respirators be tested for operability prior to each use but that such tests (user seal checks) are not quantitative and there is no requirement to document the check. It was suggested that this requirement be deleted. The NRG staff does not intend that user seal checks (fit checks) be quantitative nor that they be documented. User seal checks have been required by the NRG since 1979 and are well known to the industry. Licensee training programs describe the procedures and the procedures are subject to periodic licensee and NRG audits. The need to perform a user seal check (fit check) prior to each use is considered an essential safety procedure, consistent with industry practice and ANSI guidance. This requirement is retained.

A commenter stated that§ 20.1703(c)(2) requires the use of bioassays during respirator

• use in order to evaluate actual intakes and that for certain radionuclides, such as W-and Y-class forms of thorium and Y-class forms of uranium, bioassay techniques are relatively insensitive. The NRG staff observes that § 20.1204, "Determination of internal exposure,"

permits the use of air sampling, bioassays or combinations of these measurements to assess dose from the intake of radioactive materials. The final § 20.1703(c}(2) states that a licensee shall implement and maintain a respiratory protection program that includes surveys and bioassays,*as necessary, to evaluate actual intakes. The intent of this provision is to identify elements required to be addressed in the program description. This section does not replace § 20.1204 which permits methods other than bioassay to be used to determine dose from intake.

8

A commenter observed that under the proposed rule, if a licensee determined that a work situation did not require the use of respirators but a worker requested one, then a respiratory protection program would be required to be in effect. This is true for any respirator that has been assigned an APF in Appendix A. However, the rule now recognizes the use of disposable filtering facepieces (dust masks) without an APF. If no credit is to be taken for their use then program elements such as a medical exam and fit test are not required. Other program elements such as minimal training on limitations of the devices and correct methods of use are required.

A comment was made that the final rule should establish the extent to which emergency

• planning efforts must incorporate the programmatic requirement of 10 CFR 20: 1703. 10 CFR

• Part 20 does not directly address emergency situations but provides programmatic requirements for normal operations. However, § 20.1001 notes that " ... nothing in this part shall be construed as limiting actions that may be necessary to protect health and safety." This suggests that in the event of an emergency, such as a major release or spill of radioactive material, conditions would need to be assessed and the need for res...,;ratory protection determined. Licensees should determine whether or not an emergency situation could reasonably be expected to arise that would require the establishment of a respiratory protection program, and how extensive that program would need to be. For nuclear power plants,§ 50.47 (b)(B) requires "adequate ... equipment to support the emergency response." This includes respiratory protection equipment that would be needed in an emergency and a program for its use.

In NUREG-6204, Question and Answers Based on Revised 10 CFR Part 20, a question I

was posed as to whether the requirements of 10 CFR 20.1703 apply to respiratory protection equipment that is to be used only in emergencies. The NRC staff position is that if the equipment is to be used to limit intakes of radioactive material, this requirement applies. Also, 9

footnote i to the new Appendix A makes it clear that full facepiece, Self-Gontained-Breathing-Apparatus (SGBA) operating in pressure demand, or positive pressure recirculating mode may be used as an emergency device in unknown concentrations for protection against inhalation hazards. If a licensee determined that there was sufficient likelihood of an emergency situation, including significant airborne radioactive material, to justify the maintenance of emergency use SGBA, then a program would be necessary to assure the safe use of the equipment should it

• be needed. The NRG staff believes that any respiratory protection program that meets Part 20 requirements should provide a good basis for respirator use in emergency situations. Further guipance is provided in Regulatory Guide 8.15.

A commenter stated that§ 20.1703(b) requires application to the Commission for approval to use respiratory devices not tested or certified by NIOSH. It was suggested that this application would not be necessary if the respirator were used in a situation where no protection factor was needed. The program elements described in § 20.1703 come into effect "... if the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioacti~a material." The NRG clarified the statement of considerations to help define "limit intake." In effect, if a licensee determines that respiratory protection is not required to limit

• intake of radioactive material and a respirator is used for some other reason, then the

§ 20.1703 conditions are not applicable. However, in this case, other regulations would govern the use of respirators. For example, if a worker requests a respirator that will not be used to limit intakes of radioactive material, then OSHA or State requirements would come into play.

For example, OSHA requirements for the voluntary use of disposable filtering facepieces (dust masks) would be little more than brief instruction on the limitations of the device and correct methods of use. NRG, as well as OSHA requirements for the use of tight-fitting, half or full-facepiece respirators are more extensive, including medical evaluation.

A suggestion was made that § 20.1703(d) should include instructing a worker that a respirator could be removed in any situation where the user judges that his or her health is at risk due to physical or psychological stress caused by use of the respirator. The NRG staff

• believes the present language in this section and guidance in Reg. Guide 8.15, is adequate to assure that a worker knows when and how to secure relief from respirator-induced stress.

A commenter requested that provisions be added to allow the use of combination full facepiece, pressure demand, supplied air respirators with auxiliary self-contained air supply for use during emergency entry into an unassessed environment. The NRG staff intends that Appendix A Section Ill, Combination Respirators, include any devices or combinations of devices as approved by NIOSH in 42 CFR Part 84.70. Regulatory Guide 8.15 provides further guidance on the use of combination respirators. The NRG staff does not believe that any change is needed in the regulation to permit (and continue to allow) the use of these approved devices.

A commenter questioned the statement in footnote e of Appendix A that " ... no distinction is maua ... between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the face piece (e.g., disposable or reusable

• disposable}." The commenter observed that there is no assurance that a filtering facepiece would provide the same degree of protection as a respirator equipped with an elastomeric facepiece. The NRG staff agrees with this statement and has assigned a protection factor of 1O only to devices having elastomeric face sealing properties and two or more adjustable straps.

Filtering facepieces not having these design features are the first entry in Appendix A and are not given an APF.

A commenter observed that proposed footnote e would permit the use of filtering facepiece respirators (dust masks) without medical screening or fit testing. The footnote also provides that if a licensee can demonstrate a fit factor of at least 100 using an acceptable fit 11

test protocol, then an APF of 1O can be used. At question is whether the medical screening becomes nec~ssary if the device qualifies for an APF. The waiver of medical screening in the new footnote d is based on the fact that these devices do not impose physiological stress

'" because they are light weight, do not have a tight seal, and do not contribute significantly to breathing resistance. The use of these devices, such as dust masks, is likely to occur in response to a worker's request for a respirator when the licensee has determined that a respirator is not needed. Under these circumstances, the least burdensome design available should be used. If a* filtering facepiece device passes a fit test, and is to be used to limit intake, and an APF greater than 1 is used to estimate intake, then a full program is required including

• medical screening. This requirement is consistent with the recent OSHA regulations.

A suggestion was made that Appendix A could be clearer with more explanatory text in the table, fewer footnotes, and terminology that tracks OSHA. The NRG staff has revised Appendix A to some extent, by spelling out modes of operation and adopting OSHA terminology whenever possible.

A suggestion was made that Appendix A would be less complicated ii there was only one column of APF values. The NRG staff agrees and the APF column for air purifying respirators is now labeled Particulate, and the columns of APFs for atmosphere supplying respirators and combination respirators are now labeled Particulate, Gases, and Vapors.

A commenter obsetved that footnote a should reference OSHA regulations in addition to 29 GFR 1910. The NRG staff agrees and footnote a in the final rule references Department of Labor regulations. The revised Regulatory Guide 8.15 discusses OSHA regulations *and guidance in more detail.

A commenter observed that the NRG-proposed filter efficiency requirements specified in proposed footnote c do not take into account the observation that filter performance is far better in the field than under NIOSH certification testing conditions. The NIOSH tests are 12

conducted at extreme conditions such as high flow rates, the challenge aerosol is selected to be the most penetrating particle size, and long test durations are used. Under field conditions most filters perform at nearly 100 percent efficiency.

Also it is not necessarily most protective to select a high efficiency filter because that results in a higher pressure drop across the filter which could increase breathing resistance and lead to a greater possibility of leakage around the seal as well as increased worker stress. The NRC staff agrees with this comment and final footnote b is changed to specify 95 percent efficiency filters for APFs less tha.n 100, 99 percent efficiency filters for APFs equal to 100, and 99.97 percent efficiency for APFs greater than 100.

• A commenter suggested that some language in proposed footnote d be clarified and that the* last sentence could be covered in the text of the rule. The NRC staff has revised the first sentence in final footnote f to read, "The assigned protection factors for gases and vapors are not applicable to radioactive contaminants that present an absorption or submersion hazard." The last sentence in proposed footnote d made it clear that some sorbent cartridges have been proven to be effective against airborne gases and vapors and, after NRC staff review and approval on a case-by-case basis, the NRC will continue to permit their use. This

• provision clearly modifies information in Appendix A. The NRC staff believes it should remain in the footnotes. With the restructuring of Appendix A, this information is found in new footnotes c and f. More detailed discussion of the criteria for approval of sorbent cartridges against gases and vapors has been added to Regulatory Guide 8.15.

A *commenter suggested deleting proposed footnote e because the initial statement to the effect that filtering facepieces may be used without medical screening or fit testing applies to all tight fitting respirators. That is not the case. Fit testing and medical screening are required for any respirator that is assigned a protection factor (APF). Only disposable, filtering facepieces without elastomeric sealing surface and adjustable straps that do not have an APF 13

can be used without medical screening. If the devices are fit tested in order to use an APF, then medical screening would also be required.

This commenter suggested that the caution in the proposed footnote e to the effect that it is difficult to perform positive or negative pressure user seal checks on filtering facepiece respirators is not based on technical information. The statement is based on cumulative experience in the industry and inspection by the NRC staff of a large number of filtering facepiece respirators that do not have elastomeric sealing surfaces and adjustable straps. In most cases, it was very difficult for highly experienced respirator users to effectively perform a user seal check on filtering facepiece respirators in the negative or positive pressure mode .

• A commenter proposed deleting the last sentence in the final footnote i that warns against using SCBA in pressure demand or recirculating positive pressure modes if any outward leakage of breathing gas is perceived. This is an important warning for use of these devices in emergencies or unassessed situations because leakage could significantly reduce the expected duration of the air supply and thus stay time. Premature exhaustion of the air supply could result in serious injury or death of a worker in an Immediately Dangerous to Life and Health (IDLH) area. This warning appropriately modifies the assigned protection factor for this type of device.

A commenter suggested several revisions to the NRC proposed definitions; Based on several comments the NRC staff has decided to use OSHA definitions for consistency and the OSHA definitions are consistent with the suggestions made by this commenter.

A commenter questioned the use of the words "as necessary in§ 20.1703 (c)(2). The intent of the words "as necessary is that surveys or bioassays should be included in the program only if a licensee believes that these methods would be needed to determine intake.

For example, if air sampling during all procedures indicates that no radioactive material is ever released into the air, then evaluation of actual intakes using bioassay would not be necessary.

14 .

Section 20.1204, Determination of internal exposure, states that for purposes of determining dose the licensee shall measure concentrations, do bioassay, whole body count, or combinations of these measurements. The purpose of § 20.1703(c)(2) is to identify elements of an acceptable program that may need to be included in the program, not to require performance of bioassay if it is not needed.

A commenter observed that the proposed § 20.1701 stated that The licensee shall use, to the extent practicable, process or other engineering controls (e.g. containment, decontamination, or ventilation) to control the concentration of radioactive material in air. The word "practicable" is used in place of "practical'~ as found in the current regulations. The NRC

• staff agrees with this comment to the effect that "practicable" would require any action that was "possible," whereas "practical" specifies action that would be "useful". The word "practical" is consistent with "reasonable" as found in ALARA, As Low as Is Reasonably Achievable, and the final rule has been changed to retain the word "practical."

A commenter observed that the proposed definition of "fit factor" is a quantitative measure of the fit of a respirator to an individual. The proposed definition of fit test" is a test, quantitative or qualitative to evaluate the fit of a respirator and to determine the fit factor. The commenter states that a qualitative fit test cannot yield a quantitative fit factor. In fact, approved qualitative fit test protocols are considered by NIOSH, OSHA, and ANSI to imply minimum quantitative fit factors, usually limited to 100.

However, because the NRC has decided to adopt the OSHA definitions, the final rule defines fit factor as " ... a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of substance in ambient air to its concentration inside the respirator when worn." This definition permits use of a challenge medium whose concentration at ambient temperature and pressure can be estimated (C 1 ) and

• if not detected by the test subject, a maximum concentration inside the mask can be assumed, 15

(C2 ). The estimated fit factor would then be the ratio G/C2

• These qualitative fit factors are permitted to be used to determine fit factor, and Reg. Guide 8.15 will provide more detailed guidance on the use of approved protocols.

A commentor suggested that the listing of irritant smoke (hydrogen chloride) as an acceptable challenge agent in a user seal check (fit check), be removed. There is evidence of health risks associated with exposure to this chemical agent, not only to the worker but also to the person performing the test. The NRC staff has decided to keep this option as one of the acceptable user seal checks along with positive and negative pressure check and isoamyl acetate, because both OSHA and ANSI list it. _However, the final version of Reg. Guide 8.15

• will include a caution regarding excessive exposure to this agent as well as some suggestions for performing user seal checks with irritant smoke so as to minimize exposure.

This commentor pointed out that deleting the words " ... or had certification extended" from § 20.1703(a) and § 20.1703(b), is appropriate but that users should be advised that any particulate respirators certified under 30 CFR Part 11 remain certified. The new certification regulations are at 42 CFR Part 84. The NRC staff agrees, and the statement of considerations includes a note to this effect, and Reg. Guide 8.15 discusses certification in more detail.

• The commentor questioned the wording in§ 20.1703(c)(3) that would exempt respirators with no APFs from user seal checks for tight fitting respirators and functional or operability .checks for others such as atmosphere supplied suits. The NRC staff agrees that if a d.evice is capable of being fit checked or operability checked then these checks should be performed each time the device is used whether or not a APF is used. The words " ... with APFs ..." are removed from§ 20.1703(c)(3).

It was observed that § 20.1703(c)(6) does not specify that fit testing measures face seal rather than equipment operation and therefore must always be performed with the facepiece operating in the negative pressure mode. This provision has been changed to be consistent 16

with ANSI. Also, the proposed requirement to fit test any tight-fitting, positive pressure, continuous flow and pressure demand devices to a fit factor ~ 100 is inconsistent with the OSHA specification of 500. This difference could result in workers using different masks depending on whether the respirator was used for protection against radiological or non-radiological hazards. It was further stated that a fit factor of 100 may be too low for full-face tight- fitting masks because it in fact would represent a relatively poor fit. The NRC staff believes that the OSHA recommended fit factor of 500 is not difficult to achieve and provides an additional increment of safety. The final rule reflects this change.

A commenter observed that Appendix A-lists a positive pressure (PP) operational mode

• for some air purifying respirator types. This designation refers to "powered air purifying respirators (PAPR)" and should be so designated. The NRC staff agrees and has made this change.

A commenter suggested the use of "intake" or "dose from internal radioactive material,"

instead of "internal exposures," because there is some confusion regarding the meaning of that term. The NRC staff has reviewed the final rule and, whenever approl-'iiate, more precise terminology has been used as suggested.

A commenter references question number 91 in NUREG/CR-6204, Questions and Answers Based on Revised 10 CFR Part 20, in which the NRC staff stated that the requirements in 10 CFR 20.1703(a) must be met to use respiratory protection whether or not credit is taken for the device. This statement was made before the NRC staff recognized the utility of permitting the use of disposable filtering facepieces (dust-masks) not equipped with elastomeric sealing surfaces and adjustable straps. The NRC continues to require compliance with § 20.1703(a) if respiratory protection is used. However, dust masks and other similar devices can be used, probably on request of a worker, without fit testing or medical screening.

These half-face, light-weight devices do not present any significant physiological stresses and 17

are to be used in situations that do not require limiting intake. Therefore, these devices can be removed at any time they become stressful without any harm to the user. Minimal training on the limitations and proper use of the devices would be required.

The commentor observed that the proposed rule would require fit factors that are ten times the APF for the specific negative-pressure air-purifying device, but that the rule does not specify how this fit testing can be accomplished. The NRG staff notes that guidance on fit testing, both quantitative and qualitative protocols, is found in Reg .. Guide 8.15.

A commentor states that the term "adequate communication" in§ 20.1703(e) may be difficult to demonstrate due tq the limited communications options available with some respiratory devices and that "adequate" is subject to interpretation. The NRG staff agrees and intends that this requirement be determined by licensee judgement. Adequate, or "sufficient for a specific requirement," is discussed in Reg. Guide 8.15, and guidance as to what constitutes adequate communication is provided. This is not a new requirement and the NRG staff is not aware of licensees having difficulty with its implementation.

T: ,e com mentor questioned the requirement in § 20.1703(f) for "direct communication between the standby rescue person and the worker because it might be necessary for the standby person to be in a high radiation area or otherwise be exposed to radiation or physiological stress. The NRG staff agrees and has changed this section to require the standby rescue person to "maintain continuous communication" with the workers. Acceptable communication methods are identified as, visual, voice, signal line, telephone, radio, or other suitable means.

The commentor stated that proposed § 20.1703(h) regarding materials or substances that might interfere with the seal of a respirator did not adequately reflect the discussion in the statement of considerations, and that, because the fit test proves the ability to properly maintain a seal, this restriction is not needed. The NRG staff observes that a fit test is not performed 18

every time that a worker uses a respirator. A user seal check might work with some obstruction in the seal area but then break down in the work situation. To better reflect the scope and intent of this provision and to be consistent with OSHA, the NRC staff has added the underlined words as follows: (h) No objects, materials, or substances, such as facial hair, or any other conditions that interfere with the face - facepiece seal or valve function, that are under the control of the respiratqr wearer, are present.. ..

A commenter suggested elimination of the planned revision of NUREG-0041, "Manual of Respiratory Protection Against Airborne Radioactive Material," because the document contains information that is found elsewhere and is redundant. The NRC staff agrees that it would not be useful to repeat information that is found elsewhere and one reason for updating and revising the NUREG is to eliminate and avoid redundancy. The document will be a technical source for NRC licensees setting up or operating respiratory protection programs that will include many references to ANSI, NIOSH, and other documents that describe acceptable programs. Only procedures unique to protection against airborne radioactive material will be addre;..,sed in detail if no other sources are available.

The com mentor observed that waiving the medical screening requirement for the use of

• single-use disposable respirators is inconsistent with OSHA. In fact, OSHA waives the medical screening requirement for any voluntary use of filtering facepiece respirators. The assumption is that if a licensee determines that a respirator is not needed (meets ALARA considerations) but a worker requests one, then the least intrusive device should be used, such as a disposable, filtering facepiece with no APF that would be unlikely to expose the worker to physiological stress. The NRC position is consistent with that of OSHA.

Several commentors questioned the use of 15 percent loss of worker efficiency when using a respirator as a recommended, upper bound default value if a licensee is not able to justify a higher value. An EPRI study, for example, showed that loss of worker efficiency did 19

not exceed 7 percent. Other measurements resulted in findings of 25 percent loss of efficiency under conditions requiring respiratory protection. With this range, a recommended default value of not more than 15 percent, as specified in Reg. Guide 8.15 seems reasonable. The guide provides suggestions for determining an efficiency loss factor that would be job and site specific.

A commentor questioned the need to apply to the Commission for the use of an APF greater than 1 for sorbent cartridges as protection against airborne radioactive gases and vapors (e.g., radioiodine). The commentor stated that the NRG should specify the same APF listed for particulate filters for radioactive gases or vapors with good warning properties. The

• NRG staff is aware that most radionuclides (e.g., airborne radioiodines) have poor to no warning properties. For this reason, the NRG staff intends to continue requiring a specific case approval process with some demonstration of effectiveness before approval for use.

A commentor suggested permitting "a licensed health care professional," in addition to a physician, to determine that a person is medically fit to use a respirator, as is done by OSHA.

The established NRG position, as described further in Reg. Guide 8.15, condnues to be that a licensed health care professional can administer a medical exam, but the program must be

• designed by, and be under the supervision of a physician. The NRG staff is aware that serious injury and death can occur if a person with certain medical conditions is permitted to use a respirator.

In May of 1991 the Commission published a major revision to 10 CFR Part 20 that required a licensee to implement and maintain a respiratory protection program that includes

" ... Determination by a physician ... that the individual user is physically able to use the respiratory protection equipment." In the statement of considerations for that final rule, the Commission noted " ... the decision on the physical ability of an individual to wear a respirator is a subjective judgement that in the Commission's opinion, requires the decisionmaker to have a 20

medical degree." In 1995 the Commission reaffirmed this position in a rulemaking that revised the required frequency of medical examination. However, the statement of considerations for that rulemaking stated " ... The NRC staff believes that physicians need not administer each test personally, but that the physician may designate someone such as an office nurse to certify medical fitness as long as it is clear that the physician is ultimately responsible for the fitness determination. Likewise the NRC staff believes that the physician should be involved in the supervision of the fitness program, the review of overall results and individuals cases that fall outside certain physician determined parameters, and supervision of personnel performing the tests."

This position is in agreement with ANSI recommendations as stated in ANSI - Z88.6 1984. Regulatory Guide 8.15, Rev. 1, "Acceptable Programs for Respiratory Protection states that, "The medical evaluation program should be carried out by the physician, or by a certified, medically trained individual such as a registered nurse (RN), licensed practical nurse (LPN),

emergency medical technician (EMT), or someone who, in the judgement of the licensee's physician, has adequate experience, education, training, and judgement to administer the screening program." This is consistent with OSHA's regulations that permit a "licensed health care professional" to administer the fitness screening program.

A commenter observed that ANSI 288.2-1992, does not include APFs for SCBA used in the pressure-demand or positive pressure recirculating modes, because some workplace simulation tests showed that up to 5 percent of workers don't achieve protection factors that high. ANSI instead suggests that APFs up to 10,000 should be used only for emergency planning purposes. Footnote a to Appendix A in the NRC regulation makes it clear that the APFs apply only to airborne radiolog~,cal hazards and not when chemical or other respiratory hazards exist.

21

A commentor suggested deletion of irritant smoke and isoamyl acetate as example of a user seal check because these are not checks that a user can perform without assistance. The NRG staff agrees but does not preclude the use of assistance in performing a user seal check.

It is common for a technician to perform user seal checks on a work crew preparing for entry to a job site requiring respirators. If no assistance is available then clearly positive or negative pressure checks would be the available options.

It was suggested that more guidance be provided on functional check or testing for operability. The NRG staff agrees and Reg. Guide 8.15 will be expanded to provide more guidance on accepted techniques.

It was suggested that more specificity regarding actual procedures be put in the rule or the Reg. Guide and*that requirements for addressing non-routine and emergency use of respirators should be added. The NRG staff does not agree because respiratory programs should be site and work specific and the intent of revising the rule was to make it more performance based. Considerable guidance on acceptable methods exists and is referenced in Reg. Guide 8.15 or NUREG-0041.

A commenter said that NRG should require use of the OSHA medical check questionnaire, or its equivalent. The NRG staff agrees that the OSHA questionnaire is an acceptable way, along with appropriate medical oversight, to medically screen workers to use respirators safely, but that other methods are also acceptable. In the interest of maintaining a performance-based rule, the NRG will rely on review of a licensee's/physician's judgement regarding the best way to qualify workers. The OSHA questionnaire is referenced in Reg.

Guide 8.15 for guidance.

It was suggested that provisions for vision, communication, and low temperature protection be made at no cost to the employee. The NRG staff believes that this issue is 22

outside the scope of 1O GFR Part 20 and should be addressed between workers and licensee management.

A commenter suggested adding a definition for "Immediately Dangerous to Life or

--Health," IDLH. Subpart H of 1o GFR Part 20 provides program requirements for respiratory protection against airborne radioactive material. It would be extremely rare for airborne concentrations of radioactive material to reach IDLH levels. IDLH refers to industrial and toxic chemical hazards that NRG licensees must be alert to in compliance with OSHA regulations. It would be inappropriate for NRG to suggest that airborne radiological condition would require a definition of IDLH. OSHA_defines IDLH as "... an atmosphere that poses an immediate threat to life, would cause irreversible adverse health effects, or would impair an individuals' ability to escape from a dangerous atmosphere."

It was suggested that § 20.1703(f) state that a sufficient number of standby rescue persons must be immediately available to provide effective emergency rescue. The NRG staff agrees and these words have been added.

A commenter observed that the APFs specified by NRG in Appendix A are not in complete agreement with those recommended by ANSI. The difference for disposable filtering facepieces (dust masks) has been discussed. Any other differences between the ANSI recommended APFs and those specified by the NRG in the proposed rule have been eliminated in this final rule in the interest of p~oviding greater consistency with ANSI recommendations.

Eight comment letters were received regarding the draft Reg. Guide 8.15. All of the suggested changes derived from comments made on proposed Subpart H of 1O GFR Part 20.

Reg. Guide 8.15 has been revised based on this analysis of comments submitted on the proposed rule and the changes that have been made to the rule as discussed in this section.

23

Ill. Summary of Changes This final rule amends § 20.1003, "Definitions", §§ 20.1701 through 20.1704, adds

--§ 20.1705, and amends Appendix A to Part 20.

In § 20.1003, the NRG is adding definitions for Air-purifying respirator, Assigned protection factor (APF), Atmosphere-supplying respirator, Demand respirator, Disposable respirator, Filtering facepiece (dust mask), Fit factor, Fit test, Helmet, Hood, Loose-fitting facepiece, Negative pressure respirator, Positive pressure respirator, Powered air-purifying respirator (PAPA), Pressure demand respirator, Qualitative fit test (QLFT), Quantitative fit test (QNFT), Self-contained breathing apparatus (SGBA), Supplied-air respirator (SAR) or airline respirator, Tight-fitting facepiece and User seal check. These added definitions clarify the new regulations at §§ 20.-1701 through 20.1705.

In § 20.1701, the word "decontamination" is added to the list of examples of process or engineering controls that licensees should consider for controlling the concentration of radioactive material in air. The NRG intends that licensees consider decontamination, consistent with maintaining total effective dose equivalent (TEDE) ALARA, to reduce resuspension of radioactive material in the work place as a means of controlling internal dose instead of using respirators.

Section 20.1702 is revised to clarify that if a licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological. A reduction in the TEDE for a worker is not reasonably achievable if, in the licensees' judgement, an attendant increase in the worker's industrial health and safety risk would exceed the benefit obtained by the reduction in the radiation risk. Regulatory Guide 8.15, "Acceptable Programs For Respiratory Protection", and NUREG-0041, "Manual of Respiratory Protection Against Airborne Radioactive Material" address how factors such as heat,

• 24

discomfort, reduced vision, etc., associated with respirator use, might reduce efficiency or increase stress thereby increasing dose from external sources or health risk. The NRC expects that licensees will exercise judgment in determining how nonradiological factors apply to

'selecting an appropriate level of respiratory protection. In the proposed rule this amendment would have been accomplished by adding a footnote to paragraph (c). The NRC has instead restructured the section to add similar language to a new subparagraph § 20.1702(b) in the text of the rule to facilitate clarification of this important provision.

Section 20.1703 states the requirements for licensees who use respiratory protection equipment to limit intake of radioactive material. The use of a respirator is, by definition,

• intended to limit intakes of airborne radioactive materials, unless the device is clearly and.

exclusively used for protection against non-radiological airborne hazards. Whether or not credit is taken for the device in estimating doses, use of the respiratory protection device to limit intake of radioactive material and associated physiological stresses to the user activates the requirements of § 20.1703. Thus § 20.1703 defines the minimum respiratory protection program expected of any licensee who assigns *or permits the use of rt::spirators to limit intake.

The term "limit intake of radioactive material" is not specifically defined in this rule. The licensee must determine whether the use of a respirator for protection against non-radiological airborne hazards or at the request of a worker also limits the intake of radioactive material. If so a §20.1703 program is required. An acceptable approach is for the licensee to evaluate the I

existing or potential airborne concentrations of radioactive material (from routine operations; likely operational occurances, and credible emergency conditions) and determine whether a Part 20, Subpart H respiratory program would have been required by the concentration of radioactive material. If the analysis shows that respiratory protection would not have been required in order to limit intake of radioactive material, then compliance with Subpart H would not be required. Respirators used for the express purpose of protection against non-25

radiological hazards, and that only incidentally limit the intake of radioactive materials that may be present in the air, are not considered to fall under the "limit intake" category. Such respirator use is not regulated by Subpart H provisions.

However, respiratory protection that is used to protect against non-radiological hazards or at the request of a worker invokes OSHA program requirements. The programmatic requirements prescribed by OSHA are commensurate with the degree of hazard present, ranging from a program more prescriptive than Subpart H to brief instruction on safety issues in the case of the voluntary use of "dust masks." Under a Memorandum of Understanding between the NRC and OSHA, the NRC inspection staff is obligated to notify the licensee and

• OSHA if industrial safety problems are observed.

In§ 20.1703(a), the phrase "pursuant to§ 20.1702" is removed. This language has been misinterpreted to mean that an approved respiratory protection program is not needed if respirators are used when concentrations of radioactive material in the air are already below values that define an airborne radioactivity area. Section 20.1703 now makes it clear that, if a licensee uses respiratory protection equipment "to limit intakes,"* the provisions of § 20.1703 are the minimum applicable requirements.

In final § 20.1703(a), licensees are permitted to use only respirators that have been tested and certified by NIOSH. The words "or had certification extended" are removed because all existing extensions have expired and no new extensions will oe granted except for classes of respirators certified under 42 CFR Part 84. (Note: The respiratory certification regulations at 42 CFR Part 84 replaced those previously at 30 CFR Part 11 for air purifying respirators.

Devices formerly certified under 30 CFR Part 11 remain certified but newer devices certified under 42 CFR Part 84 have demonstrated improved performance).

In final § 20.1703(b), licensees are permitted to apply for authorization to use equipment that has not been tested or certified by NIOSH. The words "and has not had certification 26

extended by NIOSH/MSHA" have been removed because all existing extensions have expired and no new extensions will be granted except for classes of respirators certified under 42 CFR Part 84. The words "to the NRC" are added to make it clear that applications for authorized use of respiratory equipment must be submitted to the Commission.

In new§ 20.1703(c), paragraphs (c)(1) through (5) are retained as presently codified with the exception of some minor editing. Paragraph (c)(4) is reworded to improve clarity, reorder priorities, and bring together in one paragraph all of the elements of the required written procedures. Paragraph (c)(5) is revised to clarify that the worker's medical evaluation for using non-face sealing respirators occurs before first field use, not before first fitting (as required for

• tight fitting respirators) because fit testing is not needed for these types.

A new§ 20.1703(c)(6) is added to require fit testing before first field use of tight-fitting, face sealing respirators and periodically after the first use. This change clarifies when and how often fit testing is required. The NRC requires that the licensee specify* a frequency of retest in the procedures, that may not exceed 1 year (see HPPOS-219 for NRC staff position on testing intervais). The proposed rule would have extended the retest period up to three (3) years, However, public comment and the NRC's intent to be consistent with OSHA requirements, convinced the NRC staff to retain annual fit testing. (See Analysis of Public Comment).

The new§ 20.1703(c)(6) also codifies existing NRC staff guidance and ANSI recommendations regarding the test "fit factors" that must be achieved in order to use the APFs. Specifically, fit testing with "fit factors" ~ 1O times the APF is required for tight fitting, negative pressure devices. A fit factor~ 500 is required for all tight fitting face pieces used with positive pressure, continuous flow, and pressure-demand devices. ANSI recommended a fit factor of 100 for these devices but OSHA selected 500 to provide an additional safety margin.

The NRC staff agrees with the OSHA position and in the interest of consistency is specifying 500. This provision is intended to maintain a sufficient margin of safety to accommodate the 27

greater difficulty in maintaining a good "fit" under field and work conditions as compared to fit test environments. It is important to note that all tightfitting facepieces are to be fit tested in the negative pressure mode regardless of the mode in which they will be used.

Current § 20.1703(a)(4), which required licensees to issue a written policy statement, is removed because the NRC believes that it is not needed. All of the elements that were required to be in the policy statement are already found in Part 20 and in the requirement for licensees to have and implement written procedures (see§ 20.1703(c)(4)).

The requirements of§ 20.1703(a)(6) have been moved to§ 20.1703(e), clarified and expanded to emphasize the existing requirements that provisions be made for vision correction, adequate communications, and low-temperature work environments. A licensee is required to account for the effects of restricted vision and communication limitations as well as the effects*

of adverse environmental conditions on the equipment and the wearer. The NRC considers the inability of the respirator wearer to read postings, operate equipment and/or instrumentation, or properly identify hazards to be an unacceptable degradation of personnel safety.

A requirement for licensees to consider low-temperature work environments when selecting respiratory protection devices is added in§ 20.1703(e). The NRC believes that this requirement is needed because the moisture from exhaled air when temperatures are below freezing could cause the exhalation valve on negative pressure respirators to freeze in the open position. The open valve would provide a pathway for unfiltered air into the respirator inlet covering without the user being aware of the malfunction. Lens fogging that reduces vision in a full facepiece respirator is another problem that can be caused by low temperature.

The reference to skin protection in § 20.1703(a)(6) has been removed. The NRC does not consider skin protection to be an appropriate reason for the use of respirators (with the exception of air s~pplied suits). Limitation of skin dose is currently dealt with elsewhere in the regulations (§ 20.1201 (a)(2)(ii), skin dose limit). It may be inconsistent with ALARA to use tight 28

fitting respirators solely to prevent facial contamination. Other protective measures such as the use of faceshields instead of respirators, or decontamination should be considered.

A new § 20.1703(f) is added to include a requirement for standby rescue persons in the regulatory text. This requirement was previously contained in a footnote in Appendix A to Part 20. This provision retains a requirement for standby rescue persons to be present whenever one-piece atmosphere-supplying suits, or any other combination of supplied air respirator device and protective equipment are used that are difficult for the wearer to take off without assistance. Standby rescue persons would also need to be in continuous communication with the workers, be equipped with appropriate protective clothing and devices, and be immediately available to provide needed assistance if the air supply fails. Without continuous air supply, unconsciousness can occur within seconds to minutes.

A new§ 20.1703(9) moves a requirement from a footnote in Appendix A to Part 20, into regulatory text. This paragraph specifies the minimum quality of supplied breathing air, as defined by the Compressed Gas Association (CGA) in their publication G-7.1, "Commodity Specification for Air," 1997, that must be provided whenever atmosphere-supplying respirators are used. This change which recognizes the CGA recommendations for air quality, was

• initiated by NIOSH and endorsed by ANSI. The quantity of air supplied, as a function of air pressure or flow rate, would be specified in the NIOSH approval certificate for each particular device and is not addressed in the rule.

A new§ 20.1703(h) is added to clarify and move a requirement from the footnotes of Appendix A into regulatory text. This provision prohibits the use of respirators whenever any objects, materials, or substances such as facial hair, or any other conditions interfere with the seal of the respirator. The intent of this provision is to prevent the presence of facial hair, cosmetics, spectacle earpieces, surgeons caps, and other things from interfering with the respirator seal, exhalation valves, and/or proper operation of the respirator.

29

Section 20.1703(b}(1) discussed the selection of respiratory protection equipment so that protection factors are adequate to reduce intake. This paragraph permitted selection of less protective devices if that would result in optimizing TEDE. The NRC staff believes that this requirement is redundant with the requirement to be ALARA. These recommendations are removed from the regulation and are now discussed in revised Regulatory Guide 8.15.

The remainder of§ 20.1703(b)(1) has been moved to § 20.1703(i) and incorporates the new ANSI terminology _for "assigned protection factor". This paragraph retains the provisions for changing intake estimates if later, more accurate measurements show that intake was greater or less than initially estimated.

Section 20.1703{b}{2), specifying procedures for applying to the NRC to use higher APFs, has been moved to § 20.1705.

Section 20.1703(c) is rem_oved because it requires licensees to use only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by NIOSH, as emergency devices. Because only equipment approved by NIOSH or NRC can be used in the respiratory protection program pursuant to§ 20.1703(a) and (b), this provision is redundant. The revisions of Regulatory Guide 8.15 and NUREG-0041

• discuss acceptable types of emergency and escape equipment .

Section 20.1703(d) is removed. This provision required a licensee to notify the director of the appropriate NRC Regional Office in writing at least 30 days before the date that respiratory protection equipment is first used so that the NRC staff could review the licensee program. Licensees who possess radioactive material in a form that requires a respiratory protection program are expected to submit a program description during the license application, amendment, or renewal processes. Their programs would be reviewed during this process. A 30-day notification requirement imposes a needless administrative burden on licensees with no increase in worker health and safety. This change is considered to be a burden reduction.

30

Section 20.1704(a) is revised to clarify that the Commission will use ALARA considerations in any additional restrictions imposed by the Commission on the use of respiratory protection equipment for the purpose of limiting exposures of individuals to airborne radioactive materials.

Appendix A to Part 20 - " Assigned Protecti~n Factors for Respirators," is modified extensively. In general, new devices are recognized, APFs are revised to be consistent with current ANSI guidance and technical knowledge, and the footnotes to Appendix A are moved, deleted, revised, or adjusted so that only those necessary to explain the table remain.

Footnotes that are instructive or that facilitate. implementation of the rule are being moved to Regulatory Guide 8.15. Several footnotes are considered to be redundant in that they reiterate NIOSH certification criteria to be discussed in NUREG-0041 and are removed. Generic regulatory requirements, previously contained in footnotes in Appendix A, have been moved to the text of Part 20.

The column headed "Tested and Certified Equipment" is removed from the table. The references to Titles 30 and 42 of the CFR currently found in this column apply primarily to respirator manufacturers and are not very useful to NRC licensees. Instruction on how to

• determine if a respirator is NIOSH approved are provided in the revision to NUREG-0041.

The column headed Gases and Vapors is deleted, and the APFs for Air Purifying respirators are designated "particulate only," while APFs for Atmosphere s*upplying and Combination Respirators are designated for "particulate, gases and vapors". This change simplifies Appendix A.

Footnote a to Appendix A is removed because it is redundant with air sampling requirements and requirements for estimating possible airborne concentration addressed in

§ 20.1703(c)(1) and§ 20.1703(i).

31

Footnote b, which permits the use of devices only when nothing interferes with the seal of a face piece, has been moved to the text of the rule at§ 20.1703(h).

Footnote c, proposed footnote b, which defines the symbols for modes of operation, is removed as a result of public comment and operating modes are spelled out in Appendix A.

Footnote d.1 is removed because the essential information regarding the meaning and use of APF is in § 20.1703(i). Further guidance regarding the application and limitation of APFs is provided in the revisions of Regulatory Guide 8.15 and NUREG-0041.

Footnote d.2(a) stated that APFs are only applicable for trained individuals who are properly fitted and for properly maintained respirators. This footnote is redundant because adequate provisions for training, fit-testing, and equipment maintenance are found in the final rule (§ 20.1703(c)(4)).

Footnote d.2(b) stated that APFs are applicable for air-purifying respirators only when high-efficiency particulate filters are used in atmospheres not deficient in oxygen and not containing radioactive gas or vapor respiratory hazards. This statement is revised and included in footnote b to say that if using a respirator with an APF less than 100, a filter with a minimum efficiency of 95 percent must be used. Air purifying respirators with APF = 100 must use a filter with an efficiency rating of at least 99 percent. Respirators with APF >- 100 must use filters with at least 99.97 percent efficiency. Further guidance is provided in Regulatory Guide 8.15 and NUREG-0041. The definitions of filter types and efficiencies are discussed in the revisions of Regulatory Guide 8.15 and NUREG-0041.

Footnote d.2(c) stated that APFs cannot be used for sorbents against radioactive gases and/or vapors (e.g., radioiodine). This is no longer an absolute prohibition. A provision is made in footnote c for licensees to apply to the Commission for the use of an APF greater than 1 for sorbent cartridges.

32

Footnote d.2(d) restated part of the NIOSH approval criteria for air quality for supplied air respirators and self-contained breathing apparatus. This requirement is changed to reflect the fact that air quality standards derive from ANSI's recognition of the Compressed Gas

• Association guidance, and is moved to the text of the rule (§ 20.1703(g)). Air quality is discussed further in Regulatory Guide 8.15 and NUREG-0041.

Footnote e.made it clear that the APFs for atmosphere-supplying respirators and self-contained breathing apparatus are not applicable in the case of contaminants that present a skin absorption or submersion hazard. This statement is*retained in footnote fin Appendix A to Part 20. However, the current exception provided for tritium oxide requires correction in that the effective protection factor cannot exceed 3, rather than 2 as previously stated. This correction is made to footnote f of Appendix A. This basis for this change is discussed further in revised NUREG-0041.

Footnote f stated that canisters and cartridges for air purifying respirators will not be used beyond service-life limitations. This observation restates a NIOSH approval criterion and is more appropriate to guidance than to the regulations. This footnote is removed. Service life limitations are addressed in Regulatory Guide 8.15 and NUREG-0041.

Footnote g addressed four issues. The first limits the use of half-mask facepiece air purifying respirators to "under-chin" types only. This limitation is retained in footnote e to the new Appendix A to Part 20. The only type of facepiece eliminated by this requirement is the so-called "quarter-mask" which seals over the bridge of the nose, around the cheeks and between the point of the chin and the lower lip. These devices can exhibit erratic face-sealing characteristics, especi.ally when the wearer talks or moves his/her mouth.

The second issue precluded this type of respirator if ambient airborne concentrations can reach instantaneous values greater than 1O times the pertinent values in Table 1, Column 3 33

of Appendix B to Part 20. Because respirator assignment is now based on TEDE, ALARA, and other considerations, this part of footnote g is removed from the new footnote e.

The third issue precluded the use of this type of respirator for protection against plutonium or other high-toxicity materials. Half-mask respirators, if properly fitted, maintained, and worn, provide adequate protection if used within the limitations stated in the NIOSH approval and in the rule. The NRG finds no technical or scientific basis for continuing this prohibition in view of current knowledge and it is removed.

Finally this footnote required that this type mask be checked for fit (user seal check) before each use. This provision is removed because§ 20.1703(c)(3) requires a user to perform

• a user seal check (e.g., negative pressure check, positive pressure check, irritant smoke check) each time a respirator is used.

Footnote h provided several conditions on air-flow rates necessary to operate supplied air hoods effectively. Because all of these requirements are elements of the NIOSH approval criteria, they are redundant and are removed. These NIOSH requirements are discussed further in the revision to NUREG-0041.

Footnote i specified that appropriate protection factors be determined for atmosphere-supplying suits based on design and permeability to the contaminant under conditions of use. Conditions for the use of these devices are retained in footnote g to the revision of Appendix A. Guidance on the use of these devices and on determining appropriate protection factors is included in the revision to Regulatory Guide 8.15. Footnote i also required that a standby rescue person equipped with a respirator or other apparatus appropriate for the potential hazards, and communications equipment be present whenever supplied-air suits are used. This requirement is moved to the text of the rule (§ 20.1703(f)).

Footnote j stated that NIOSH approval schedules are not available for atmosphere-supplying suits. This information and criteria for use of atmosphere supplying suits is 34

addressed in footnote g to Appendix A. Note that an APF is not listed for these devices.

Licensees may apply to the Commission for the use of higher APFs in accordance with

§ 20.1703(b).

Footnote k permitted the full facepiece self-contained breathing apparatus (SCBA),

when operating in the pressure-demand mode, to be used as an emergency device in unknown concentrations. This provision is retained in footnote i to Appendix A, and full facepiece SCBA operating in positive pressure, recirculating mode is added.

Footnote I required quantitative fit testing with a leakage less than 0.02 percent for the use of full facepiece, positive pressure, recirculating mode SCBA. This requirement is removed

• from the footnotes and fit test criteria consistent with ANSI guidance are inserted at

§ 20.1703(c)(6}. Fit testing is addressed in the revision to Regulatory Guide 8.15.

Footnote I also stated that perceptible outward leakage of breathing gas from this or any positive pressure SCBA whether open circuit or closed circuit is unacceptable, because service life will be reduced substantially. This provision is retained in footnote i to Appendix A.

Footnote I also required that special training in the use of this type of apparatus be provided to the user. The NRC believes that the training requirement that would be retained at

§ 20.1703( c)( 4) is adequate to assure the training necessary for the use of SCBA devices. This element of footnote I is removed.

Note 1 to Appendix A to Part 20 discussed conditions under which the protection factors in the appendix may be used, warned against assuming that listed devices are effective against chemical or respiratory hazards other than radiological hazards, and stated the need to take into account applicable approvals of the U.S. Bureau of Mines/NIOSH when selecting respirators for nonradiological hazards. Note 1 is retained in footnote a to Appendix A and amended to reference Department of Labor (DOL} regulations. The NRC believes that these 35

conditions are essential to the safe use of respirators and that the DOL regulations also apply when hazards other than radiological respiratory hazards are present.

Note 2 to Appendix A warned that external dose from submersion in high concentrations of radioactive material may result in limitations on occupancy being governed by external dose limits. This note is retained as the second paragraph of footnote a to Appendix A to Part 20.

In the title of Appendix A, and throughout the rule, the term "assigned protection factor" (APF) is used to be consistent with the new ANSI 288.2-1992 terminology.

Although ANSI suggested an APF = 10 for all half-mask filtering facepiece disposable respirators, disposables thatdo not have *seal-enhancing elastomeric components and are not

• equipped with two or more adjustable suspension straps are permitted for use but do not have an APF assigned (i.e., no credit may be taken for their use). The NRC believes that without these design features it is difficult to maintain a seal in the workplace. These devices have little physiological impact on the wearer, may be useful in certain situations, and they may accommodate workers who request respiratory protection devices as is required by OSHA.

Medical screening is not required for each individual prior to use because the devices impose very little physiological stress. In addition, fit testing is not required because an APF is not specified (i.e., no credit may be taken for their use). However, all other aspects of an acceptable program specified in § 20.1703 are required including training of users in the use and limitations of the device. The NRC believes that this provision allows the flexible and effective use of these devices without imposing conditions that are burdensom.e.

However, for those licensees who would like to use the ANSI-recommended APF of 10 for filtering facepiece (dust masks), footnoted to Appendix A permits an APF of 1Oto be used if_

the licensee can demonstrate a fit factor of at least 100 using a validated or evaluated, quantitative or qualitative fit test. This requirement is consistent with ANSI recommendations 36

because fit testing is an explicit component of the ANSI respirator program. The full § 20.1703 program would then be needed including a medical evaluation.

The half-facepiece respirator continues to be approved with an APF = 10, but relatively

• • new variations of this type of device are referred to in the industry as "reusable," "reusable-disposable," "filtering facepiece" or "maintenance-free" devices. In these devices, including those considered to be disposables, the filter medium may be an integral part of the facepiece, is at least 95 percent efficient, and may not be replaceable. Also, the seal area is enhanced by the application of plastic or rubber to the face-to-facepiece seal area and the 2 or more suspension straps are adjustable. These devices are acceptable to the NRC, are considered

• • half facepieces, may be disposable, and are given an APF = 10, consistent with ANSI recommendations. Individual workers must achieve a fit*factor of at least 100 to use the APF of 10.

The APF for full facepiece air purifying respirators operating in the negative pressure mode is increased from 50 to 100. This change is consistent with ANSI recommendations based on review of industry test results. Appendix A previously listed a protection factor of 50 because one design that was tested at Los Alamos in 1975 did not meet the protection factor

\

criterion of 100. This device is no longer available.

A fit factor of 1O times the APF for tight fitting, negative-pressure air-purifying respirators, which must be obtained as a result of required fit testing under§ 20.1703(c)(6), is recommended by ANSI and is required under the new rule. A person would have to achieve a minimum of 1,000 on a fit test in order to use an APF of 100 in the field. Requiring a fit factor of 1O times the APF for negative pressure devices effectively limits intake and protects against any respirator leakage that might occur during workplace activities. A fit factor ;;,: 500 is required for any positive pressure, continuous flow and pressure demand device. The 37

proposed rule had stated a fit factor of 100. However, public comment suggested this number was too low, and OSHA rules also require 500.

A new category of respirator, the loose-fitting facepiece, positive pressure (powered) air

• purifying type, is included in Appendix A to Part 20. An APF of 25 is assigned to this new device in accordance with ANSI 288.2-1992.

The half facepiece and the full facepiece air-line respirators operating in demand mode were listed in the proposed rule with APFs unchanged at 5. In order to be consistent with ANSI and with public comment, the APFs for these two devices have been changed. The new APF for the half facepiece is 1O, and the APF for the full facepiece is 100. The NRG believes that supplied-air respirators operating in the demand mode should be used with great care in nuclear applications. Because they are very similar in appearance to more highly effective devices (continuous flow and pressure-demand supplied air respirators), they might mistakenly be used instead of the more protective devices.

The APFs for half-and full-facepiece air-line respirators operating on continuous flow are reduced from 1,000 to 50 and from 2,000 to 1,000 respectively. The APF for a full facepiece air-line respirator operating in pressure-demand mode is reduced from 2,000 to 1,000. These

• changes are based on ANSI recommendations and the results of field and laboratory experiences indicating that these devices are not as effective as originally thought. This change is expected to have little impact on licensees because typical workplace concentrations encountered are far less than 1000 times the derived air concentrations (DACs). However, licensees may apply for higher APFs if needed and justified. A half-mask air-line respirator operating in pressure-demand mode is added to Appendix A with an APF of 50 based on ANSI recommendations. The helmet/hood air-line respirator operating under continuous flow is retained with the APF listed as 1,000. Footnote h which specified NIOSH certification criteria 38

for flow rates is removed. The criteria for air flow rates are part of the NIOSH approval and are addressed in the revision to NUREG-0041.

The new loose-fitting facepiece design is also included as an air-line respirator operating under continuous flow. This device is assigned an APF of 25 in Appendix A consistent with ANSI recommendations.

The air-line atmosphere-supplied suit is not assigned an APF. These devices have been used with no APF for many years in radiological environments, such as control rod drive removal at boiling water reactors. These devices are primarily used as contamination control devices, but they are supplied with breathing air. No worker safety problems are known to have

• occurred at nuclear power plants or other NRC licensees that would disallow use of these devices. The NRC is allowing the use of non-NIOSH~approved suits but wearers are required to meet all other respirator program requirements in § 20.1703 except the need for a fit test.

Licensees have an option to apply to the Commission for higher APFs for these devices in accordance with § 20.1703(b). Requirements for standby rescue persons apply to operations where these devices are used (§ 20.1703(f)).

In Appendix A to Part 20, APFs for SCBA devices remain unchanged except for those

. operating in demand or demand recirculating modes. APFs for these two devices have been changed from 5 to 100 to be consistent with ANSI and in response to public comment. Use of SCBA in demand open circuit and demand recirculating mode requires considerable caution.

The chance of facepiece leakage when operating in the negative pressure mode is considerably higher than when operating in a positive pressure mode. This is* especially critical for devices that could be mistakenly used in immediately dangerous to life and health (IDLH) areas during emergency situations. Although ANSI lists relatively high APFs for these devices, they are not recommended by the NRC for use and acceptable alternative devices are readily 39

available. Footnote h requires that controls be implemented to assure that these devices are not used in IDLH areas.

A specific statement is added in footnote f, to exclude radioactive noble gases from consideration as an inhalation hazard and advising that external (submersion) dose considerations should be the basis for protective actions. DAC values are listed for each noble gas isotope. This has led some licensees to inappropriately base respirator assignments in whole or in part on the presence of these gases. The requirement for monitoring external dose can be found in 10 CFR 20.1502 .

• IV. Issue of Compatibility for Agreement States In accordance with the Policy Statement on Adequacy and Compatibility of Agreement State Programs published September 3, 1997 (62 FR 46517) and implementing procedures, the modifications to§ 20.1701 through§ 20.1703 (except 20.1703(c)(4)), have health and safety significance and Agreement States should adopt the essential objectives of these rule modifications. Therefore, these provisions are assigned to the "Health and Safety (H&S)"

category. The definitions (added to§ 20.1003), of Air Purifying respirator, Atmosphere-supplying respirator, Assigned Protection Factor (APF), Demand respirator, Disposable respirator, Fit factor, Fit test, Filtering facepiece (dust mask), Helmet, Hood, Loose-fitting facepiece, Negative pressure respirator, Positive pressure respirator, Powered air-purifying respirator, Pressure demand respirator, Qualitative fit test, Quantitative fit test, Self-contained

• breathing apparatus, Supplied-air respirator, Tight-fitting facepiece, and User seal check (fit check), because of their precise operational meanings, are designated as compatibility category B to help insure effective communication and to promote a comrnon understanding for 40

licensees who operate in multiple jurisdictions. Therefore, Agreement States should adopt definitions that are essentially identical-to those of NRG.

§ 20.1703(c)(4) and § 20.1704, which address requirements for written procedures, and imposition of additional restrictions on the use of respiratory protection, respectively, are designated as compatibility category D.

Appendix A to 10 CFR Part 20, and § 20.1705 which permits applying for the use of higher APFs on a case by case basis, are designated as compatibility category 8. Consistency is required in APFs that are established as acceptable in NRG and Agreement State regulations to reduce impacts on licensees who may operate in multiple jurisdictions .

• V. Finding of No Significant Environmental Impact: Availability The NRG has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the amendments are not a major Federal action significantly affecting the quality of the human environment and therefore, an environmental impact statement is not required.

The amendments make technical and procedural improvements in the use of respiratory protection devices to maintain total occupational dose as low as is reasonably achievable.

None of the impacts associated with this rulemaking have any effect on any places or entities outside of a licensed site. An effect of this rulemaking is expected to be a decrease in the use of respiratory devices and an increase in engineering and other controls to reduce airborne contaminants. It is expected that there would be no change in radiation dose to any member of the public as a result of the revised regulation.

The determination of this environmental assessment is that there will be no significant offsite impact to the public from this action. Therefore, in accord with its commitment to 41

complying with Executive Order 12898 - Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, dated February 11, 1994, in all its actions, the NRC has also determined that there are no disproportionate, high, and adverse impacts on minority and low-income populations. The NRC uses the following working definition of "environmental justice": the fair treatment and meaningful involvement of all people, regardless of race, ethnicity, culture, income, or educational level with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.

The NRC requested public comments and the views of the States on the environmental assessment tor this rule. No comments were received that addressed changes to the environmental assessment.

The environmental assessment is available tor inspection at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.

VI. Paperwork Reduction Act Statement This final rule decreases the burden on licensees by eliminating reporting requirements

• in § 20.1703(a)(4) and (d). The burden reduction tor this information collection is estimated to be 250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br /> annually. Because the burden reduction tor this information collection is insignificant, compared to the overall burden of 10 CFR Part 20, Office of Management and Budget (0MB) clearance is not required. Existing requirements were approved by the Office of Management and Budget, approval number 3150-0014.

42

VI I. Public Protection Notification If a means used to impose an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

VII I. Regulatory Analysis The NRC has prepared a regulatory analysis for the amendments. The analysis examines the benefits and impacts considered by the NRC. The regulatory analysis is available for inspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level),

Washington, DC.

IX. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the NRC certifies

• that, this rule will not have a significant economic impact on a substantial number of small entities. The anticipated impact of the changes will not be significant because the revised regulation basically represents a continuation of current practice. The benefit of the rule is that it provides relief from certain reporting and recordkeeping requirements, incorporates several ANSI recommendations for improved programmatic procedures, and permits the use of new, effective respiratory devices, thus increasing licensee flexibility.

43

X. Backfit Analysis Although the NRC staff has concluded that some of the changes beirig made constitute a_reduction in burden, the implementation of these and other changes will require revisions to

. licensee procedures constituting a backfit under 10 CFR §§ 50.109(a)(1 ), 72.62(a)(2), and 76.76{a){1 ). However, because the rule incorporates national consensus standard (ANSI) recommendations that are worker safety related, the NRC staff believes that this rule constitutes a substantial increase in the overall protection of public health and safety that is cost justified.

The Regulatory Analysis that was prepared for this rule concluded that the rule would result in a net benefit to industry of about $1.5 million dollars per year, including the cost of revising procedures. The largest savings result from eliminating the need for a written policy statement and permitting the use of disposable, filtering facepieces instead of more expensive respirators. For most of the other changes made in this final rule, the costs of implementing the change are equal to the estimated cost savings. The Regulatory Analysis further concludes that compared to the practice under the current Part 20, Subpart H, each change either involves no change in value/impact, or represents an improvement in regulatory protection of worker health and safety without any significant added costs (i.e., all value), or presents the potential for reductions in regulatory burden and/or increased operational flexibility with net savings to licensees and the NRC.

Many of th.e changes only clarify existing requirements (i.e., reduce the potential for licensee misunderstandings) or formally adopt recommendations of the current ANSI standard 288.2 - 1992.

Section Ill in this FR Notice, Summary-of Changes, summarizes the changes to Subpart H of 10 CFR Part 20. The reasons for making these changes are also provided. Many 44

of the changes are considered by the NRG to constitute a substantial worker safety enhancement in that they reflect new consensus technical guidance published by the American National Standards Institute (ANSI) on respiratory protection developed since 10 CFR Part 20,

--- Subpart H was published. The changes include recognizing new respirator designs and types that were not available 20 years ago, changing the assigned protection factors (APFs) based on new data, deleting certain reporting requirements which are considered no longer needed for oversight of a mature industry, and numerous procedural improvements that have been developed and proven by respiratory practitioners.

Permitting the use of disposable, filtering facepieces, for example, accommodates

• workers who voluntarily use respiratory protection when it is not needed. These devices provide some respiratory protection, do not impose stress or breathing resistance on workers as do more cumbersome designs, and when credit is not being taken for their use, do not require medical screening or fit testing.

Current NRG regulations list APFs that are iriconsistent with current national consensus standards. APFs are used to select types of respirators to provide needed degree of protection, and to estimate the intake and internal dose workers might receive. The new, and correct, APFs will provide a substantial increase in worker protection.

Deleting two paperwork requirements that are no longer considered useful or needed will permit resources to be redirected to more important safety matters.

Incorporation of the ANSI fit test criteria provides a needed safety margin that protects against deteriorating conditions in the workplace that affect facepiece seal.

The rule also leads to greater uniformity of practice in that the new requirements are consistent with the general respiratory protection regulations published recently by OSHA.

NRG licensees are often subject to OSHA respiratory protection regulations when the intent is to protect workers against non-radiological inhalation hazards. This final rule would not require 45

a licensee to maintain two distinct programs, and only minor differences exist between the OSHA requirements and this final rule.

In addition the new rules provide greater flexibility in practice in that several new devices are now approved for use. Numerous prescriptive requirements are deleted because they are redundant or no longer needed. The Assigned Protection Factors currently in Appendix A of 10 CFR Part 20 are incorrect; some are too conservative and others might underprotect the worker. This rule corrects the APFs in the NRC regulations according to the national consensus standard recommendations of ANSI.

In conclusion, the Commission believes that for quantitative and qualitative reasons, this rule change constitutes a burden reduction and a substantial increase in the overall protection of public (worker) health and safety that is cost justified.

XI. Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of 0MB.

XII. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995, Pub. L. 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule the NRC is using recommendations 46

from the following voluntary consensus standard, "American National Standard for Respiratory Protection,"

(ANSI 288.2), American National Standards Institute, 1992.

List of Subjects in 10 CFR Part 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and recording requirements, Special nuclear material, Source material, Waste treatment and disposal.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C.

552 and 553, the NRC is adopting the following amendments to 10 CFR Part 20.

PART 20- STANDARDS FOR PROTECTION AGAINST RADIATION

1. The authority citation for Part 20 continues to read as follows:

AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (U.S.C. 5841, 5842, 5846).

2. Section 20.1003 is amended by adding the definitions Air-purifying respirator, Assigned protection factor (APF). Atmosphere-supplying respirator, Demand respirator, Disposable respirator, Filtering facepiece (dust mask). Fit factor, Fit test, Helmet, Hood, Loose-47

fitting facepiece, Negative pressure respirator, Positive pressure respirator, Powered air-purifying respirator (PAPR), Pressure demand respirator, Qualitative fit test (QLFT).

Quantitative fit test (QNFT), Self-contained breathing apparatus (SCBA). Supplied-air respirator (SAR) or airline respirator, Tight-fitting facepiece and User seal check (in alphabetical order) to read as follows:

§ 20.1003 Definitions.

Air-purifying respirator means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element. * * * *

• Assigned protection factor (APF) means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

Atmosphere-supplying respirator means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

Demand respirator means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

Disposable respirator means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of 48

respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

Filtering facepiece (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering r:nedium, not equipped with elastomeric sealing surfaces and adjustable straps.

Fit factor means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn .

• Fit test means the *use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

Helmet means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

Hood means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

Loose-fitting facepiece means a respiratory inlet cqvering that is designed to form a partial seal with the face.

Negative pressure respirator (tight fitting) means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

49

Positive pressure respirator means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

Powered air-purifying respirator (PAPR) means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

Pressure demand respirator means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation:

Qualitative fit test (QLFT) means a pass/fail fit test to assess the adequacy of

• respirator fit that relies on the individual's response to the test agent.

Quantitative fit test (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

Self-contained breathing apparatus (SCBA)_ means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

Supplied-air respirator (SAR) or airline respirator means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

Tight-fitting facepiece means a respiratory inlet covering that forms a complete seal with the face.

50

User seal check (fit check) means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

SUBPART H - Respiratory Protection and Controls to Restrict Internal Exposure

3. Section 20.1701 is revised to read as follows:

§ 20.1701 Use ot process or other engineering controls.

The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.

4. Section 20.1702, is revised to read as follows:

§ 20.1702 Use of other controls.

(a) Wh~n it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in the air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, *increase monitoring and limit intakes by one or more of the following means --

(1) Control of access; (2) Limitation of exposure times; (3) Use of respiratory protection equipment; or (4) Other controls.

(b) If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The 51

licensee should also consider the impact of respirator use on workers' industrial health and safety.

5. Section 20.1703 is revised to read as follows:

. § 20.1703 Use of individual respiratory protection equipment.

If the licensee assigns or permits the use of respiratory protection equipment to limit the

• intake of _radioactive material, (a) The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this part.

(b) If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no sch,edule for testing or certification, the licensee shall submit an application to the NRG for authorized use of this equipment except as provided in this part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information.

(c) The licensee shall implement and maintain a respiratory protection program that includes:

(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses; (2) Surveys and bioassays, as necessary, to evaluate actual intakes; (3) Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use; (4) Written procedures regarding 52

(i) Monitoring, including air sampling and bioassays; (ii) Supervision and training of respirator users; (iii) Fit testing; (iv) Respirator selection; (v) Breathing air quality; (vi) Inventory and control; (vii) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment; (viii) Recordkeeping; and

• (ix) Limitations on periods of respirator use and relief from respirator use; (5) Determination by a physician that the individual user is medically fit to use respiratory protection equipment; before (i) The initial fitting of a face sealing respirator; (ii) Before the first field use of non-face sealing respirators, and (iii) Either every 12 months thereafter, or periodically at a frequency determined by a physician.

(6) Fit testing, with fit factor ~ 1O times the APF for negative pressure devices, and a fit factor ~ 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

(d) The licensee shall advise each respirator user that the user may leaye the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

53

(e) The licensee shall also consider limitations appropriate to the type and mode of use.

When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or

• radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of th~ respirator.

(f) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipme!lt and to provide effective emergency rescue if needed.

(g) Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997.

(h) The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face - facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece. *

(i) In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by 54

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the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.

6. Section 20.1704 is revised to read as follows:

§ 20.1704 Further restrictions on the use of respiratory protection equipment.

The Commission may impose restrictions in addition to the provisions of §§ 20.1702, 20.1703, and Appendix A to Part 20, in order to:

(a) Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and (b) Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

7. Section 20.1705 is added as follows:

§ 20.1705 Application for use of higher assigned protection factors.

The licensee shall obtain authorization from the Commission before using assigned protection factors in excess of those specified in Appendix A to Part 20. The Commission may authorize a licensee to use higher assigned protection factors on receipt of an application that -

(a) Describes the situation for which a* need exists for higher protection factors; and (b) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

55

8. Appendix A to Part 20 is revised to read as follows:

APPENDIX A TO PART 20 ASSIGNED PROTECTION FACTORS FOR RESPIRATORSa Assigned Protection Operating Mode Factors I. AIR PURIFYING RESPIRATORS [particulateb only]"

Filtering facepiece disposabled Negative Pressure (d)

Facepiece, half" Negative Pressure 10 Facepiece, full Negative Pressure 100 Facepiece, half Powered air-purifying respirators 50 Facepiece, full Powered air-purifying respirators 1000 Helmet/hood Powered air-purifying respirators 1000 Facepiece, loose-fitting Powered air-purifying respirators 25

• II. ATMOSPHERE SUPPLYING RESPIRATORS

[particulate, gases and vapors 1]

1. Air-line respirator Facepiece, half Demand 10 Facepiece, half Continuous Flow 50 Facepiece, half Pressure Demand 50 Facepiece, full Demand 100 Facepiece, full Continuous Flow 1000 Facepiece, full Pressure Demand 1000 Helmet/hood Continuous Flow 1000 Facepiece, loose-fitting Continuous Flow 25 Suit Continuous Flow (g)

2. Self-contained breathing Apparatus (SCBA)

Facepiece, full Demand 100h Facepiece, full Pressure Demand 10,0001 Facepiece, full Demand, Recirculating 100h Facepiece, full Positive Pressure Recirculating 10,0001 Ill. COMBINATION RESPIRATORS Any combination of air-purifying and atmosphere-supplying Assigned protection factor for type and mode of operation respirators as listed above

a. These assigned protection factors apply only in a respiratory protection program that meets the requirements of this Part. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances must also comply with Department of Labor regulations.

56

Radioactive contaminants for which the.concentration values in Table 1, Column 3 of Appendix B to Part 20 are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits .

.. b. . Air purifying respirators with APF -< 100 must be equipped with particulate filters that are at least 95 percent efficient. Air purifying respirators with APF = 100 must be equipped with particulate filters that are at least 99 percent efficient. Air purifying respirators with APFs >- 100 must be equipped with particulate filters that are at least 99.97 percent efficient.

C. The licensee may apply to the Commission for the use of an APF greater than 1 for sorbent cartridges as protection against airborne radioactive gases and vapors (e.g.,

radioiodi ne).

d. Licensees may permit individuals to use this type of respirator who have not been medically screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized that it is difficult to perform an effective positive or negative pressure pre-use user seal check on this type of device.

All other respiratory protection program requirements listed in § 20.1703 apply; An assigned protection factor has not been assigned for these devices. However, an APF equal to 1O may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test.

e. Under-chin type only. No distinction is made in this Appendix between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are acceptable so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least 95 percent efficient and all other requirements of this Part are met.

f. The assigned protection factors for gases and vapors are not applicable to radioactive contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of 3 is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external (submersion) dose considerations.

g. No NIOSH approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (i.e.,

§ 20.1703).

57

h. The licensee should implement institutional controls to assure that these devices are not used in areas immediately dangerous to life or health (IDLH).

i. This type of respirator may be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure such as skin absorption shall be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device.

Dated at Rockville, Maryland this

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l!. day of ¥, 1999.

For the Nuclear Regulatory Commission.

Andr\; L. Bates Acting Secretary of the Commission.

58

Department of Energy OOCKETt.D Germantown, MD 20874-1290 USN ,..

January 29, 1999 "99 FEB -5 P3 :16 OF,

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Secretary ADJU' J F U.S . Nuclear Regulatory Commission ATTN: Rulemaking and Adjudications Staff Washington, D.C. 20555-0001 DOCKET NUMBER PROPOSED RULE ,:;o

( 1,,3F~38511)

Dear Secretary:

The U.S . Department of Energy (DOE), with over 120,000 Federal and contractor employees, is a significant user of respirators. Over 20 percent of DOE contractors use a respirator at some time in their career. Our contractors follow Occupational Safety and Health Administration (OSHA) respiratory regulations and American National Standards Institute (ANSI) 288.2-1992.

Each of our sites has a defined respiratory protection program and administrator. In addition, our Federal workforce comes under OSHA regulation. Paducah and Portsmouth, former DOE sites, also come under OSHA regulation.

DOE is quite concerned over potential conflicts between current OSHA and the proposed amendment to the Nuclear Regulatory Commission (NRC) respiratory protection regulations because in the near future DOE sites may be regulated by both OSHA and NRC. As written, the proposed NRC amendment to title 10, Code of Federal Regulations, part 20 (10 CFR 20)

(63 Federal Register 38511 , July 17, 1998), could result in DOE having to implement two distinct respiratory protection programs (one for each agency' s regulations). This could adversely impact worker safety and lead to additional unnecessary program costs.

DOE recommends that the NRC standard and supporting guidance be as consistent as possible with the OSHA standard. DOE provides the following reasons for this recommendation:

o Executive Order (EO) Number 12866, Regulatory Planning and Review, September 30, 1993, requires Federal agencies, to the extent permitted by law, to "avoid regulations that are inconsistent, incompatible, or duplicative with its other regulations or those of other Federal agencies." [emphasis supplied] . EO 12866 also requires each agen y to "tailo its *regulations*..

• to impose the least burden on society . . . consistent with obtaining the regu i tpry ~objections .

tacking into account . . . the costs of cumulative regulations." *

• o The National Technology Transfer and Advancement Act of 1995, P .L. 104-1 f3, 110 Stat. *ns, provides that, unless it is inconsistent with applicable law or otherwise impractical, "all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards , ,. .

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2 o Relationship with OSHA respiratory protection standard: NRC has expressed a desire to minimize dual regulation of its licensees. Recently OSHA promulgated a revision to its respiratory protection standard at title 29 CFR 1910.134 (63 FR 1152, January 8, 1998, and 63 FR 20098, April 23, 1998) . Many NRC licensees are obligated to adopt OSHA standards for their non-radiological respiratory protection programs. DOE facilities now comply with OSHA and ANSI Z88.2 in a single respiratory protection program.

o Impact on external regulation of DOE: DOE is particularly sensitive to NRC regulations because of current extended regulation activities with NRC. DOE wants to resolve potential conflicts between the way DOE facilities may choose to comply with NRC recommendations and the way NRC expects DOE facilities to comply with its recommendations. DOE has a strong interest in ensuring that NRC regulations for respiratory protection are both protective of workers and consistent with current standards, including ANSI Z88.2 and OSHA, 29 CFR 1910.134.

o Lack of up-to-date technical guidance for the proposed amendments: The proposed NRC standard provides little specificity within the text of the standard or in the proposed guidance on important technical aspects of the respiratory protection program. Rather, it depends on a yet to be revised guidance document (NUREG 0041 ). The regulated community may be uncertain as to what is expected by the NRC standard until final guidance is available.

Enclosed are the DOE's specific comments on NRC's proposed rule, "Respiratory Protection and Controls To Restrict Internal Exposures," which was published in the July 17, 1998, Federal Register and the Draft Regulatory Guide 8022.

Sincerely,

~

Fitzgera , Jr.

Deputy Assistant Secretary Worker Health and Safety Enclosure cc:w/enclosure Tom Towers, OSHA

Comments on the Nuclear Regulatory Commission (NRC)

Respirator Proposed Amendment and Draft Guide (DG)-8022 Documents Reviewed:

1. Proposed rule, title 10 Code of Federal Regulations Part 20 (10 CFR 20), Respiratory Protection and Controls to Restrict Internal Exposures, 63 Federal Register 38511 - 38521, July 17, 1998.

2. NRC DG 8022, Acceptable Programs for Respiratory Protection, July 1998.

The comments below address specific provisions in the 1\TRC proposed amendments and DG.

Although the Department of Energy (DOE) recommends that the NRC standard be as consistent as possible with the Occupational Safety and Health Administration (OSHA) respiratory protection standard, DOE recognizes that NRC may not choose this alternative to its rulemaking.

DOE is therefore submitting specific comments on the proposed amendment and the DG below.

DOE has divided its comments between the proposed amendment to 10 CFR Part 20 and the DG-8022, to the extent practical. However, there is some overlap and DOE does not intend its comments to imply that specific provisions should appear in the amendments rather than in the DG. Also, many of our comments and recommendations may be more appropriately addressed in the revised guidance document (NUREG 0041 ), which has not been released for public comment.

DOE is primarily concerned that the NRC respiratory protection recommendations are clearly stated with sufficient specificity to enable licensees to know what is required and for enforcement to be uniform. In addition, as noted below, DOE has specific concerns over some of the requirements.

DOE comments on proposed amendment to 10 CFR 20:

20.1003, Definitions Fit check: Delete irritant smoke and isoamyl acetate as examples of a user fit check since these are not tests that the user should perform without assistance.

Fit factor : Use the OSHA definition, i.e., "Fit factor means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn." The significance is in the use of the word "measure" versus "estimate." Qualitative fit tests do not "measure," but they do "estimate" the fit.

Fit test: Change the word "test" to "protocol" to more accurately describe a fit test. The protocol includes the test, but also includes preparation/calibration of the testing agents/device, exercises to be preformed, calculation of fit test result, etc.

2 20.1701 DOE agrees with the addition of decontamination as an example of an engineering control.

20.1702(c) Footnote:

DOE recommends that this footnote be included within the body of the standard in order to prevent its being overlooked. This is an important requirement and should not be relegated to a footnote.

20.1703 DOE supports the language change proposed in 20.1703 to state that any use of respirators to limit intakes of radioactive material triggers the recommendations of20.1703, as a minimum.

20.1703(b)

NRC should publish general, performance-based criteria for its acceptance or rejection of applications for respirator approval.

As written, the proposed rule implies that NRC would consider applications for equipment, e.g.,

whole-body suits used for respiratory protection, that NIOSH had not tested or refused to certify.

DOE discourages NRC from independently allowing the use of respiratory protection equipment that NIOSH has not considered eligible for testing or certification.

20.1703(c)(3):

"Functional check or testing for operability" should be defined.

20.1703(c)(4):

Greater specificity should be provided for each of the topics listed, either in the regulation or in the regulatory guide. Recommendations for the written respiratory protection program to address non-routine and emergency use of respirators should be added.

3 A requirement that the written procedures must be site-specific and must be updated whenever there are changes that affect employee exposure should be added. The program should be

. reviewed annually by the licensee and revised, as needed, to reflect actual conditions and practices.

20. l 703(c)(5)

The medical evaluation should require use of the OSHA respirator questionnaire, or an equivalent questionnaire. This would complement compliance with OSHA and increase program flexibility for the facility. Physicians will be using the OSHA questionnaire for their occupational patients.

Workers will be familiar with the questionnaire as its use becomes required by OSHA.

One area of concern is medical records information collected for respirator wearers. The NRC licensee is responsible for ensuring that each respirator user at its facility meets the medical criteria established by its physician. DOE recommends that NRC include a provision (subject to State and Federal privacy laws) requiring the release or transfer of a worker's medical records upon written request by the subject worker. This requirement would provide at least four benefits. It would (1) potentially save workers the necessity of repeating medical tests in order to qualify for respirator work when they work at different sites; (2) allow the worker's employer's occupational physician to have this medical information; (3) save licensees the expense of providing medical evaluations for workers previously evaluated at other facilities; and, (4) guarantee the worker's right to information contained in the medical records held by the licensee.

OSHA regulates the retention and release of medical records at 29 CFR 1910.20 and DOE urges NRC to adopt these or similar recommendations. Consistent standards that would encourage the portability of medical records should be provided. Additionally, long-term medical record retention recommendations should be specified.

20. l 703(c)(6)

NRC has provided no scientific or technical justification for relaxing the fit test frequency from 12 to 36 months. DOE recommends that NRC publish or reference any scientific studies that support its recommendation to lengthen the fit test interval to up to three years. Absent such studies, DOE recommends retention of the 12 month fit test frequency.

20. l 703(e)

The fact that provisions for vision, communication, and low temperature are to be made at no cost to the employee should be clarified.

4 20.1703(0 This requirement should address confined spaces that require entry permits, backup rescuers, emergency conditions, etc.

• 20.1703(h)

The wording should be revised to match OSHA at 1910.134(g)(l):

(I) The employer shall not permit respirators with tight-fitting facepieces to be worn by employees who have:

(A) Facial hair that comes between the sealing surface of the facepiece and the face or that interferes with valve function; or (B) Any condition that interferes with the face-to-facepiece seal or valve function ....

...(ii) If an employee wears corrective glasses or goggles or other personal protective equipment, the employer shall ensure that such equipment is worn in a manner that does not interfere with the seal of the facepiece to the face of the user."

Appendix A DOE supports the use of the American National Standards Institute (ANSI) recommended assigned protection factors (APF).

DOE does not agree with NRC's footnote (e) regarding single use respirators. There are fit test protocols available that meet the OSHA recommendations for fit testing and comments about the difficulty of performing effective positive or negative pressure user seal checks are not appropriate since several manufacturers provide devices for user seal checks.

Combination respirators: The National Institute for Occupational Safety and Health (NIOSH) does not certify combination respirator ensembles and the use of combinations, such as APRs within an air-supplied suit, may cause significant user stress. Combining respirator types voids the NIOSH certification for the individual components, since it is not an approved use for the respirator. Use of combinations must be restricted to NRC approvals based on the total system evaluation. The Table suggests that combinations do not require special approvals, DOE does not agree with this approach.

5 DOE supports the removal of the restrictions on the use of half face respirators for protection against plutonium that were previously listed in Footnote (g).

Footnote c: Which filter efficiency is necessary for APR's with an APF less than or equal to 100:

99 or 99.7 should be clarified or this footnote should be deleted altogether.

Footnote e: It is not difficult to perform a user seal check on disposable APR's. Many manufacturers provide a fit check mold that fits over the entire facepiece for this purpose. Any discussion of feasibility should be deleted since it is feasible in the current marketplace.

Recommendations relating to DG-8022 (July 1998) that are not found in comments to the proposed amendment.

General:

NRC should ensure that the selection, frequency, and quality assurance criteria are included in the regulatory guide.

Specify the minimum content, frequency, and documentation of training.

Add monthly inspection recommendations for emergency use respirators and add licensee inspection of all respirators periodically, for example, annually. Add recommendations for the removal from service for any respirator that is discovered to be defective until it is repaired. DOE supports and currently requires a user seal check prior to each use of a tight fitting respirator.

The procedure for a user seal check should be referenced or specified. The OSHA protocol, found in Appendix B-1 to 29 CFR 1910 .134, should be referenced or incorporated.

The following items should be added: no cost to employee, confidentiality, information provided to physician, information provided by physician to licensee and to the employee, provision of a powered air purifying respirator (P APR) if employee has medical restrictions on the use of negative pressure respirators.

DOE recommends that NRC specify a minimum fit test protocol, for example, Appendix A of 29 CFR 1910.134. Regulated facilities will have to use these protocols for non-radiological respiratory protection, therefore, NRC should provide for consistency with these standards.

Unless the protocols are required, fit testing practices may not provide the necessary protection for the respirator wearer. In Section II to Appendix A, OSHA details the performance recommendations for alternative fit test protocols. NRC should incorporate these criteria as well.

6 Add recommendations for quality assurance for breathing air if the licensee produces compressed breathing air. Such recommendations should include inspection and maintenance of air compressors, locations of air compressors, and unique couplings for breathing air lines. Add recommendations for certified breathing air or testing, if air is purchased.

Specific:

Page 5, section 2.1 : It is recommended that the licensee should establish reasonable threshold values if an as low as reasonably achievable (ALARA) evaluation is performed to minimize the sum of internal and external dose. Additional guidance regarding the comparison to other industrial health and safety risks should be provided.

Page 7: It is recommended that a 15 percent inefficiency factor be used. Most of the published studies on work efficiency reduction while wearing a respirator are studies of subjects performing physically demanding tasks at close to maximal effort. Sub-maximal effort would not be expected to reduce work efficiency as greatly. Other studies have demonstrated that the use of respirators with less inspiratory resistance produces less work efficiency reduction. DOE recommends that work effort and respirator selection be evaluated before any inefficiency factors are applied.

Page 8: DOE recommends the following topics be included in the written procedures:

o A qualified respirator administrator.

o Providing respirators at no cost to employees.

o Disinfection and cleaning.

o Voluntary use of respirators.

o Inspecting emergency use respirators monthly.

Page 11 : DOE recommends quarterly or semi-annual inspections of emergency use respirators.

ANSI and OSHA require monthly inspections of this equipment. DOE recommends that monthly inspections of all emergency use respirators be required .

Page 12 and 14: The discussion of half-mask respirators indicates that only 99 and 99.97 percent efficient filters are to be used in the workplace. DOE believes that the selection of a particulate filter efficiency should be made by a health physicist or industrial hygienist who is familiar with the

7 physical properties of the contaminants. The rule should reflect that respirator selection must be made by the qualified respirator administrator or designee, based on knowledge of site specific conditions.

Page 17: DG-8022 suggests that a qualitative fit test could show a fit factor of 500. OSHA has found that the concentration limits for the test agents effectively preclude the use of qualitative fit tests (QLFT) for fit factors greater than 100. If QLFTs to meet a fit factor estimate of 500 can meet the criteria published in 29 CFR 1910.134, appendix B, section II, then and only then, should consideration be given to raising the allowable fit factor estimate obtained by QLFT.

DOE recommends that the DG should be re-written to limit the use of qualitative fit tests to determine fit factors at or below 100.

Page 18 : The conditions listed to trigger more frequent fit testing than the three-year maximum interval are conditions not always apparent to the licensee and could create discrimination issues for individual workers. One example is the weight change criterion. While this is a valid criterion, a supervisor should not be responsible for observing weight changes in employees.

This is appropriately measured in the medical clinic, but the proposed standard does not require physicians to measure body weight each year. Unless the physician were made aware of the recommendations to perform a fit test whenever there was a weight change in excess of a specified threshold, weight changes would not be reported to the licensee. Annual fit testing would reduce the impact of the development of conditions that affect a good face to facepiece seal. Also, page 18 is not correctly representing the current OSHA respirator standard, 29 CFR 1910.134, that now makes 12-month fit testing intervals mandatory for all substances, but only requires one satisfactory fit test each time.

Page 22 : DOE recommends that the NRC revise their position that one respirator manufacturer is adequate for respirator selection. In many cases, one respirator manufacturer may be sufficient, but where it is not, the licensee should be required to provide a respirator that fits, even if that means using a different manufacturer and maintaining an adequate inventory of parts for that different respirator. DOE believes that employees should be able to choose from an adequate selection so that every user can be assigned an appropriate respirator that provides an adequate fit and is comfortable to the wearer. The DG' s observation that one percent of employees are not able to achieve an adequate fit factor with only one manufacturer leaves those individuals with no legal protection since employers are not obligated to provide an alternate manufacturer or a positive pressure respirator. DOE recommends that OSHA's standard 1910.134(d)(l)(iv), "The employer shall select respirators from a sufficient number of respirator models and sizes so that the respirator is acceptable to, and correctly fits, the user," be adopted.

01 / 27 / 99 WED 14:45 FAX 202 586 6977 DOE GENERAL COUNSEL la]o11 EH 52 ~UH Ol/D7/99 "THU 12:18 FAX 301 903 7773

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RESPIRATOR SUPPORT SERVICES 2028 Virts Lane Jefferson, MD 21755-8801 Tel: (301) 834-6008 Fax: 301-682-3731 Email: jph@radix.net October 22, 1998

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Washington, DC 20555-0001 co Attn: Rulemakings and Adjudications Staff Though unfortunately late. this is to pro\'ide you with my comments on the proposed rule change to 10 CFR Part 20 as published in the Federal Register, Volume 63, Number 137 on Friday, July 17. 1998 regarding Respiratory Protection and Controls to Restrict Internal Exposures". in hopes that you wi II sti II be able to consider them.

Also enclosed are my comments on the draft re\*ision of Regulatory Guide 8.15, "Acceptable Programs !'or Respiratory Protection" \Vhich is related to this rulemaking.

I have taken the liberty of enclosing a copy ofmy curriculum vitae for your review.

Thank you in advance for your consideration of these comments. If I may provide any further information. please ad\'ise.

Curriculum Vitae Comments on 10 CFR 20 - 2 pages Comments on Reg Guide 8.15 - 2 pages Respiruto1T Protection Update - T'o/11me 8, .\'um her 1 NOV - 2 1998 f\r.knowf P,<ioed by card *****-**-***-***-**---

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RESPIRATOR SUPPORT SERVICES 2028 Virts Lane Jefferson, MD 21755-8801 Tel: (301) 834-6008 Fax: 301-682-3731 Email: jph@radix.net CURRICULUM VITAE JOHNP.HALE Established the consulting firm: RESPIRATOR SUPPORT SERVICES, in August 1989 offering training, technical services, and consulting in occupational respiratory protection on a nationwide wide basis.

PROFESSIONAL ACTIVITIES International Society for Respiratory Protection Board of Directors

• American Industrial Hygiene Association Organizational member American Society of Safety Engineers member National Fire Protection Association member American Association of Occupational Health Nurses Patron member AIHA Respiratory Protection Committee member American Standards Institute member ANSI Z88.2 subcommittee member - 1992 edition & current rewrite ANSI Z88. l Osubcommittee chairperson - current EDUCATION & TRAINING "Radiation Protection and Control" - Health Physics Services, Inc.

"In-Place Filter Testing Workshop" - Harvard School of Public Health "Quantitative Fit Testing Apparatus Using Oil Mist Test Aerosols" - Dynatech Frontier "In-House Respirator Cleaning System Training" - Hydro Nuclear Services, Inc.

Factory Authorized Service Training on SCBA Regulators - Mine Safety Appliances Factory Authorized Service Training on SCBA Regulators - Scott Aviation "Respiratory Protection at Nuclear Power Plants" - Radiation Safety Associates, Inc.

"Respirator Programs" - University ofN01ih Carolina/ Duke University/ NIOSH "Occupational Respiratory Protection #134", "Advanced Occupational Respiratory Protection", "Respiratory Protection for the Nuclear Industry", "Hazardous Waste Operations and Emergency Response", "Current Topics in Respiratory Protection",

"Respirator Fit Testing", "Self-Contained Breathing Apparatus" - DBA, Inc.

"Respiratory Protection 222A" - OSHA Training Institute "Confined Spaces" - National Safety Council/ John F. Rekus Undergraduate college courses at Frederick Community College in Maryland , Louisiana State University in New Orleans, and Monroe Community College in Michigan

CURRICULUM VITAE JOHNP. HALE PAGE TWO PREVIOUS EXPERIENCE 1988-1989 Director, Respirator Programs - Radiation Safety Associates, Inc., Hebron, Conecticut. Responsible for organizing, developing and expanding the respiratory protection services offered. Supervised contract activities, conducted training courses and served as Associate Editor of the Radiological Respiratory Protection Newsletter.

Developed and wrote complete set of Respirator Program procedures for client facility, Babcock & Wilcox/ Naval Nuclear Fuel Division .. Primarily responsible for obtaining contract with the Nuclear Regulatory Commission for the rewrite of NUREG 0041.

1985-1988 Director of Respiratory Protection Programs - Darell Bevis Associates, Inc., Chantilly, Virginia. Responsible for coordinating all training and consulting activities in the nuclear field. Served as instructor in all respiratory protection training courses offered by the company for government, general industry, and nuclear industry clients. Coordinated and supervised services in qualitative and quantitative respirator fit testing. Developed several new courses. Assisted in research projects related to respiratory protection. Conducted complete respirator program reviews and audits for client facilities.

1983-1985 Supervisor, Respiratory Protection Program - under contract to Detroit Edison Company, Fermi 2 Nuclear Power Station, Newport, Michigan. Responsible for entire development, setup and implementation of the respirator program, procedures and facilities.

1980-1983 Senior Health Physics Technician - under contract to various nuclear power plants; Three Mile Island, Dresden, Connecticut Yankee, Hatch, Rancho Seco, San Onofre, Pilgrim, Vermont Yankee, McGuire, providing radiation protection and respiratory protection technical services.

• 1976-1980 Operations Manager, Neutron Products, Inc. Managed* a new division of the company offering field service for the inspection and integrity testing of high efficiency laminar airflow devices on a nationwide basis. Also served as Manager for teh Cobal-60 Irradiator facility which utilized over a half-million curies of radioactive Cobalt-60 for sterilization and. chemical processing of various materials.

RESPIRATOR SUPPORT SERVICES 2028 Virts Lane Jefferson, MD 21755-8801 Tel: (301) 834-6008 Fax: 301-682-3731 Email: jph@radix.net 10/22/98 Page 1 of 2 Comments on Proposed Rule 10 CFR Part 20, FR VOL.63, NO. 137, 7/17/98 by: John P. Hale, Respirator Support Services re: 20.1003 Definitions Disposable respirator should be called filtering facepiece.

This will conform lo the terminology used by OSHA in their revision to 29 CFR 1910.13 4 and the agreed upon name for these products in the next revision to Z88.2. The term disposable is not descriptive nor useful. Any respirator can be disposable if cost is of no concern, or if the cost of decontamination and/or repair exceed the cost of a new device, then any respirator may be considered disposable. (this comment applies throughout the proposed rule)

Fit check (user seal check) should be called User Seal Check (formerly called fit check).

Again, this will conform with the new term used by OSHA and the next revision to ANSI Z88.2. It has been agreed that we should use the new term because it may help remove any confusion about a 'fit check' being a type of 'fit test' because of the word 'fit'. Performed properly, a user seal check will provide as much information about the integrity of the facepiece as it will the facepiece to face seal.

re: 20.1703 (c)(6)

Fit testing of positive pressure facepieces should have the same acceptance criteria as negative pressure facepieces. Since fit testing must always be done in a negative pressure mode, the acceptance criteria (required fit factor) should be at least 10 times the APF of the facepiece being tested in. Though I recognize that ANSI Z88.2-1992 says that facepieces used on positive pressure respirators only need an acceptance criteria of 100 - that provision is being changed in the revision, the subcommittee has already debated this issue and have reached a consensus in agreement of a minimum of 10 times the APF of the facepiece being tested in.

Of all the facepieces worn, those that are used with respirators that operate in a positive pressure mode, especially SCBA, are the ones that need to fit the best.

Anybody that has experience with quantitative fit testing knows, beyond a shadow of doubt, that a fit factor of l 00 on a full face piece is a terrible fit - it is very

RESPIRATOR SUPPORT SERVICES 2028 Virts Lane Jefferson, MD 21755-8801 Tel: (301) 834-6008 Fax: 301-682-3731 Email:jph@radix.net 10/22/98 Page 2 of 2 Comments on Proposed Rule 10 CFR Part 20, FR VOL.63, NO. 137, 7/17/98 by: John P. Hale, Respirator Support Services typical to see fit factors in the thousands or even ten thousands on facepieces that fit well. Almost without exception, the higher fit factors are associated with more comfortable facepieces - helping ensure that they will be worn properly in the workplace.

The issue of required frequency for fit testing is one where there is little agreement and not much real data. As you discussed in the preamble, there is anecdotal evidence at licensee facilities that suggests unlikely change in facepiece make, model, style, or size from year to year. However, nobody has really qualified that experience or put the data to scientific scrutiny. I believe part of tlie reason for seeing little change in that community is because the acceptance criteria that are used are too low. If we were to raise the required fit factor to a more meaningful level, I believe more year to year change would be seen -

especially with the aging population now at work in licensee facilities.

Both OSHA and ANSI continue to require and recommend annual fit testing.

Introducing this variable does little to help licensees that are going to be committed to following these documents anyway.

re: 20.1703 (g)

Though I agree with the reference to the CGA G7. l standard, it should be to the most recent revision which is 1997.

RESPIRATOR SUPPORT SERVICES 2028 Virts Lane Jefferson, MD 21755-8801 Tel: (301) 834-6008 Fax: 301-682-3731 Email: jph@radix.net 10/22/98 Page 1 of 2 Comments on Proposed Revision to Reg. Guide 8.15, July 98 by: John P. Hale, Respirator Support Services re: Page 3, Line 4: ... "unless the device is clearly and exclusively used for protection against nonradiological hazards."

Why does it have to be exclusively used? What if radiological and non-radiological respiratory hazards exist? In many cases, the non-radiological hazards may pose more of a health risk, but the NRC should still be concerned insofar as it may also be used to limit intakes of airborne radioactive materials. It is unclear just what was meant by this statement.

re: Page 7, 3rd paragraph: "For ALARA evaluations, a respirator-induced worker efficiency factor ofup to 15% may be used without further justification."

Where is the scientific basis for the 15% number. There is no number that can be given. Each case must be estimated based on the circumstances and merits of a given operation. It is wholly unacceptable to allow the use of a fictitious number like this. There needs to be some justification for any number used. Can we expect this number to increase along with amount of acceptable gratuity on dining out?

I have enclosed a copy of the Feature Article I published in my newsletter, Respiratory Protection Update, Vol.8, No. I (I st Qtr I 997), entitled, "Going Once, Going Twice, Sold - to the Industry with the Highest Person-Rem Price" that addresses this issue more fully and ask that it be considered as part of my comment.

re: Page 19, 5.3 Fit Testing (same as comment regarding IO CFR 20 proposal):

Fit testing of positive pressure facepieces should have the same acceptance criteria as negative pressure facepieces. Since fit testing must always be done in a negative pressure mode, the acceptance criteria (required fit factor) should be at least 10 times the APF of the facepiece being tested in. Though I recognize that ANSI ZSS.2-1992 says that facepieces used on positive pressure respirators only need an acceptance criteria of 100 - that provision is being changed in the revision, the subcommittee has already debated this issue and have reached a consensus in agreement of a minimum of IO times the APF of the facepiece being tested in.

RESPIRATOR SUPPORT SERVICES 2028 Virts Lane Jefferson, MD 21755-8801 Tel: (301) 834-6008 Fax: 301-682-3731 Email: jph@radix.net 10/22/98 Page 2 of2 Comments on Proposed Revision to Reg. Guide 8.15, July 98 by: John P. Hale, Respirator Support Services Of all the facepieces worn, those that are used with respirators that operate in a positive pressure mode, especially SCBA, are the ones that need to fit the best.

Anybody that has experience with quantitative fit testing knows, beyond a shadow of doubt, that a fit factor of 100 on a full facepiece is a terrible fit - it is very typical to see fit factors in the thousands or even ten thousands on facepieces that fit well. Almost without exception, the higher fit factors are associated with more comfortable facepieces - helping ensure that they will be worn properly in the workplace.

The issue of required frequency for fit testing is one where there is little agreement and not much real data. As you discussed in the preamble, there is anecdotal evidence at licensee facilities that suggests unlikely change in facepiece make, model, style, or size from year to year. However, nobody has really qualified that experience or put the data to scientific scrutiny. I believe part of the reason for seeing little change in that community is because the acceptance criteria that are used are too low. If we were to raise the required fit factor to a more meaningful level, I believe more year to year change would be seen.

Especially with the aging population now at work in licensee facilities.

Both OSHA and ANSI continue to require and recommend annual fit testing.

Introducing this variable does little to help licensees that are going to be committed to following these documents anyway.

re: Page 21, 5th paragraph The use of a "containment chamber around the head and torso of the fit test subject to contain the smoke" is not safe practice nor was this fit test method validated this way.

• RESPIRATORY PROTECTION UPDATE A NEWS LETTER* ISSN 1048-6658

• VOLUME 8, NUMBER 1 FEATURE ARTICLE GOING ONCE, GOING TWICE, Then something happened, people in the SOLD - TO THE INDUSTRY WITH industry started talking about the THE HIGHEST PERSON-REM possibility of dramatically reducing the PRICE number ofrespirators based on TEDE ALARA principles. Unfortunately, one Respirators of virtually every description aspect of this new thinking was based on have been used extensively in many some flawed information: specifically, industries for several decades to help the numerical assumptions about the protect workers by reducing their effect of respirators on a worker's exposure to a variety of airborne efficiency, or how much more time it contaminants. In the past, it could be may take to perform a given task with a argued that nowhere had this practice respirator versus without a respirator.

been more vigorous than in the nuclear industry. Commercial nuclear power Early in this recent history, a plants have been recognized as having

• presentation was given by Ron exceptionally well established programs, Cardarelli on the effect of respiratory facilities and equipment to support the protection on worker efficiency and use of respirators. And use them they ALARA considerations at the 31st did, thousands of respirators were used Annual Meeting of the Health Physics at many of the sites as an effective way Society meeting in Pittsburgh, PA in of decreasing worker inhalation of 1986. In this presentation the author airborne radioactive contaminants and stated that many people were assuming a also for non-radiological purposes. 25% loss of worker efficiency from using respirators, and that these Though I have held radiological assumptions were based on anecdotal respirator programs up as a model for information. The presenter went on to others to follow, I have also criticized report that a study done at Three Mile for many years the seeming rush to use Island nuclear station did not show any respirators in nuclear plants, there were significant difference.

many, many jobs that w_ere just automatic respirator jobs with little or no This remark, though I believe well real evaluation of the possibility of using intentioned, was perhaps the single most various forms of engineering and/or misquoted comment and the piece of administrative controls. But not much information that was used out of context happened, thousands of respirators were more than any other.

being used as a matter of routine in situations that really did not warrant them. (continued on page 6)

RESPIRATORY PROTECTION UPDATE is CALENDAR OF EVENTS published quarterly by Respirator Support Services, 2028 Virts Lane, Jefferson, MD 21755, AMERICAN INDUSTRIAL (301) 834-6008, FAX: 301-682-3731, E-mail:

"jph@radix.net" as part of an information update HYGIENE CONFERENCE (AIHC) subscription service for $280/calendar year. The May 17-23, 1997 News Letter alone, is available by subscription Dallas, Texas for $90/calendar year. Editor: John P. Hale

Contact:

AIHC Registration, Suite 250

• • • 2700 Prosperity Avenue NOTICE Fairfax, VA 22031-4307 This Publication is designed to provide accurate (703) 849-8888 and authoritative information in regard to the FAX# 703-207-3561 subject matter covered. It is sold with the understanding that the publisher is not engaged Future Convention Locations:

in rendering legal advice.

1998 - Atlanta, Georgia 1999 - San Diego, California COPYRIGHT 1997 2000 - Orlando, Florida REGULATIONS UPDATE INTERNATIONAL SOCIETY FOR RESPIRATORY PROTECTION NIOSH 8th Conference I September 22-26, 1997 Amsterdam The National Institute for Occupational

Contact:

Lawrence Livermore National Labs Safety and Health (NIOSH) is looking Attn: James S. Johnson, L-379 for a few good N-series respirators. ISRP Conference Their request for your help in their P.O. Box 808 project is detailed in the January 6, 1997 Livermore, CA 94550 letter on pages 3 & 4 of this newsletter.

INTERNATIONAL CONFERENCE OSHA ON OCCUPATIONAL RESPIRATORY DISEASES Latest word from a source at the October 13-16, 1997 Occupational Safety and Health Kyoto, Japan Administration (OSHA) is that the

Contact:

9th ICORD, Secretariat finishing touches are being actively c/o Japan Industrial Safety worked on for the revision to 29 CFR and Health Association 1910.134- the General Industry standard . 5-35-1, Shiba, Minato-ku for Respiratory Protection. They hope to Tokyo 108, Japan

+81-3-3452-6841 ext. 525 be done with it by the end of April. The document then goes to the Office of PUBLICATIONS Management and Budget where they are expected to take 60 to 90 days in their The International Society for Respiratory review. Therefore publication of the Protection (ISRP) has issued a Call for final rule is entirely possible by early Papers, which appears on the next page, July, 1997. Naturally, that is all subject for its upcoming Eighth Conference, to change.

September 22-25, 1997 in Amsterdam.

2

• Eighth Conference Of The International Society For Respiratory Protection CALL FOR PAPERS SHEETt ISRP The International Society Papers on any aspect of respiratory protection will be considered for the 1997 for Respiratory Protection ISRP Conference for which a list of suggested topics is given below.

(ISRP) is a non pc:ofit organisation which aims to Submission of an abstract will be required before May 31st 1997. It will also be help maintain the health helpful to receive a notification of an 'intent to present' before December 31st and safety of those who 1996 to aid in the design of the conference agenda. All material submitted will wear respiratory protective devices. be viewed before being accepted, and will be selected on the basis of quality, relevance and originality.

The Society, established in Suggested Topics :

1982, has members in over 28 countries divided into four sections.

• Effective respiratory protection programmes.

• Asbestos.

Every two years a four day

• Implementation of respiratory programmes.

• Terminology.

conference is organised to

• Evaluation of programmes.

• Firefighting.

provide a venue for ** Standards for respiratory devices.

• Assigned protection technical presentations on respirator research,

• International regulations. factors.

standards, equipment,

• Respiratory protection research.

• Chemical defence.

protection programmes

• Air filtering and air supplied respirators /

• Nuclear installations.

and use. Breathing apparatus.

• Mining industry.

It provides an opportunity

• Physiology and Bioenvironmental concerns.

• In space and under water.

for all section members

• Wor1cplace protection factor studies.

• ISO 9000 considerations .

and others to exchange information on aspects of respiratory protection.

Intent To Present :

Previous conferences have been held in St If you would like to present a paper on one of the topics listed here or any Paul, USA (1983), York, other relevant subject area then please notify the 1997 Conference UK (1985), Toronto, Canada (1987), San Co-ordinator. This can be done simply by completing your details on the Francisco, USA (1989), reverse of this Information Sheet, indicating your intent to present and then Vl/inchester, UK (1991 ),

Tokyo,Japan(1993)and sending the 'ready to Fax' pag_e to the number given.

vancolNer, canada (1995). If you don't have access to a Fax machine then copy the page details and The venue and date for send to the address provided.

the next ISRP conference is:-

Submission Of Abstract :

Eighth ISRP Conference KRASNOPOLSKY GRAN If you intend to present a paper you will need to provide the 1997 HOTEL Conference Co-ordinator with an abstract by May 31st 1997 for inclusion 22-25 Se tember 1997 in the conference booklet. However, If you are not currently in a position to provide an abstract then a simple outline of your intent to present on the Further infonnation can be form overpage will suffice until a suitable abstract is available for inclusion obtained br contacting by this date.

Peter Stee the 1997 ISRP Conference Co-ordinator :

Request For Further Information :

Address : PO Box 7228 Tadley Hampshire Further details of the 1997 ISRP Conference will be sent to you on receipt RG263WQ of your 'intent to present'. If you are interested in attending the conference England but do not intend or are unsure about presenting then indicate with a 'tick' in U.K Phone : (0118) 9826522 the box overpage to receive further information on cost, bookings, U.K Fax: (0118) 9824813 accomodation and other information sheets that are available.

This is one of a number af infonrration sheets which cover aspects af the 1997 ISRP Conference, such as booking, accomodation, spons,rshfp, exhibition, etc. A sheet, giving a simple ovetw"ew of the conference and a full list of the available information sheets can be obtained from the 1997 ISRP Conference Co-orrinator. Further sheets will be made available as and when the need arises.

1. "~sf.W/ICEs."8., DEPARTMENT OF HEALTH & HUMAN SERVICES

~4 Public Health Service Centers for Disease Control

• and Prevention (CDC)

National Institute for Occupational

• Safety and Health - ALOSH 1095 Willowdale Road Morgantown. WV 26505-2888 PHONE: (304) 285-5907 FAX: (304) 285-6030 January 6, 1997 John Hale Respirator Support Service 2028 Virts Lane Jefferson, Maryland 21755

Dear Mr. Hale:

The National Institute for Occupational Safety and Health {NIOSH) is conducting a user survey of N-series respirators certified under Title 42 Code of Federal Regulations, Part 84 {also referred to "Part 84"). The goals of this survey are to iden~ify workplace environments and contaminants that may be degrading to the filtration efficiencies of these filters~ This is a research effort and in i:lo way will be used for enforcement purposes.

This survey will involve collecting used N-series respirators from a variety of workplaces and testing their efficiencies under the conditions of the Part 84 certification test. This may provide some insight into the effects.of specific aerosols on respirator filtration efficiencies.

Along with the filters, we will be asking participants to provide the following information:

1. The make, manufacturer, and model of the N-series respirator.

2. A description of the work that was performed while wearing the respirator.

3. The duration of respirator wear.

4. A description of the materials (such as aerosols, liquids, vapors and gases) that may have challenged the re?pirator.

Only N-series filters certified under Part 84 will be accepted for this survey. All three filter efficiency classes (95%, 99%

and 99.97%) will be accepted. I emphasize that NIOSH is not- *

• Page 2 - Mr. John Hale asking anyone to collect respirators at this time.

participants in writing when it is time to do so.

I will notify Please share this information with your industrial hygiene associates and have anyone who is interested in participating contact me. My telephone number is (304) 285-5970 and my E-mail address is vzb3@niosr1J=m.cdc.gov.

Sincerely yours,

~~

• Michael Bergman Air Purfying Respirator Section Certification and Quality Assurance Branch Division of Resiratory Disease Studies

(continued from page 1) equivalent is as low as reasonably achievable (ALARA).

Whether it has been an intentional attempt to fabricate and mislead by I agree 100%, indeed this sentence might falsifying information for the benefit of even be strengthened by making the cost savings, or whether it has just been "should" a "shall" or "must":

a natural rumor-like evolution fueled by ... II exposures musth e opt"1m1ze . d" ... The a common interest in being able to article continues:

reduce respirator use for worker comfort and safety, it has happened. Emphasizing total prevention of internal exposures is contrary to ALARA principles because steps taken I happen to believe there has been a little to reduce internal exposures may cause of all of it - but that doesn't really matter. higher internal exposures.

In the end, we have not had many serious exposures, there has not been a Here, I disagree with the way the life threatening incident. So why all the sentence is worded and the resultant hoopla and complaining? Well, it is influence it may have had. I contend simply an attempt to set the record

• that it should have read: ... Emphasizing straight and maybe to get people to go total prevention of internal exposures back and look at how respirator use may be c*ontrary to ALARA principles' ...

determinations are made. And surely, it There is a big difference in the wording.

is an attempt to get people to stop The authors continue this. discussion arbitrarily using numbers like 20% and with an assumption:

30% for assumptions about respirator wearer efficiency reduction. They ar~ .. .if the worker's efficiency is reduced bogus! by I 0% or more due to wearing the respirator, the external dose equivalent One of the earliest published articles I will be increased ...

• found on this topic was A Method for Optimizing the Use ofRespiratory Where does the number 10% come Protection in RadiationAreas authored from? No clue is given. The by Steven E. Merwin and Jerome B. implication I see is that the authors Martin of Battelle - Pacific Northwest apparently felt that was a reasonable Laboratories, and Roger C. Brown of guess. I find the next step in the Westinghouse Hanford Company as thinking written about in this article published in Radiation Protection more than a little disturbing:

Management (Vol.6, No.I, pp 64-71, January/February 1989). Under the An equally important factor in the decision on issuing respirators is cost.

heading "Respirator Use Is Not Costs associated with respirator use ALARA" the authors state: include those of cleaning and maintaining the respirators and When possible, the sum of external and replacing consumables and those internal exposures should be optimized associated with worker training, fit to ensure that the total effective dose testing, and medical evaluations. Costs associated with not using respiratory protection equipment include increased 6

• bioassay frequencies, increased health physics support, and potentially higher administrative costs for documentation and reporting.

Sure, I understand virtually everything Here, a simple truth is stated, but the article goes on to describe how in the face of no scientific data, and prohibitive costs to obtain such data, you should proceed to just pick numbers that seem has a cost/benefit aspect to it - it is not reasonable to you.

justifiable to spend $50 billion on shielding to reduce exposure rates by 1 Even the lofty Health Physics Society mr/hr- but I simply fail to understand the Journal (Vol.59, No.6, pp 925-929, assumptive transition the authors make December, 1990) published a paper that that something in the conceivable cost builds an article entitled, Optimizing range of a respirator use is of any Radiation Worker Protection: The significance or can be used a factor in a Practical Application ofRisk Analysis, formula to calculate whether or not a written by Michael C. Williams of the respirator should be worn. I cannot Union Electric Company, on the think of any other workplace or industry anecdotal 25% number mentioned by where this type of rational is used - or Cardarelli in his presentation at the 31st**

should be. What this implies here is that Annual Meeting of the Health Physics radiation exposure (internal or external, Society in 1986.

or both combined - TEDE) below established annual legal limits is of no The 25% increase in work time is a typical value used to account for the consequence whatsoever, or at least that decrease in worker efficiency due to use it is not worth the cost associated with of respiratory protective equipment.

minimizing or eliminating it. How expensive is too expensive? Why should Another discussion appeared in we ever issue respirators if their use Radiation Protection Management costs anything? Yes, I read the rest of (Vol.9, No.4, pp 22-29, July/August

• the article and I think I understand it - I just think that this is classic example of the "ends justifying the means."

I would be remiss if I did not cite at least 1992) written by Regis A. Greenwood, CHP and Thomas J. O'Dou, CHP of Toledo Edison Company. In the section of their article entitled, Determination *of the Dose Due to Wearing a Respirator one more passage from this article, near they express the following:

the end of a section they call "The Optimization Method": Wearing respiratory protective devices

• (filter respirators, supplied air Another factor that may be difficult to respirators, or self-contained breathing quantify is Eff, the relative efficiency apparatus - SCBA) slows the worker in experienced by workers using the performance of the job. This is due respiratory protection. In practice, the to discomfort, reduced ability to breathe actual efficiency would be specific to freely, reduced visual acuity, tunnel each task and could only be accurately vision, and reduced communication determined by thorough (and costly) ability. Over the past 28 years working simulations of these tasks. in various parts of the nuclear industry, we have seen estimates of this increase 7

in work time within the following ranges:

Filter respirator: 10-50 percent Supplied air respirator: 20-100 percent SCBA: 50-200 percent.

your facility) from wearing respirators (see "Dose Expansion from Using Respirators," pages 22-29, in this issue).

At 25 percent, that means our break-even point is 50 mR/hr; anything higher is going to cost our worker more than 12.5 mrem each hour. In that case, For the purpose of this articl~, and for you'll have violated ALARA, and if you future planning, an increase in work have a particularly politically active time of20 percent in a radiation field worker, you may find yourself with a was chosen. This was chosen lawsuit, as well, for costing that person arbitrarily without documented unnecessary radiation dose and evidence purely as an estimate, based unwarranted physical and psychological on experience. stress.

I couldn't have said it better myself, the In a paper dated September 24, 1992, number was plucked out of the air. But, prepared for presentation at the 1992 that doesn't keep them from proceeding . REM Seminar by Benjamin W. Morgan, to use it and justify their position: Project Specialist - Health Physics, Carolina Power & Light Company, We assumed the stay time in the area entitled Guidelines for the Optimization increased by 20 percent due to wearing of Radiation Worker Protection, the a respirator. The dose without author once again reinforces a number respirator use was estimated. This was that has no*real basis in scientific fact.

calculated to be 66.34 persc;in-rem, demonstrating that 13.27 of the 79.61 person-rem received were as a result of When considering the effect of wearing respirators. respirator use on external dose the most important factor is the impact on Yet another discussion ofthis*issue worker efficiency. There is not a lot of data available yet on the effect of appeared in same issue of Radiation respirators on radiation worker Protection Management, (Vol.9, No.4, efficiency and values in the literature pp 44-48, July/August 1992) written by vary from 3% [Kahn and Baum] to 25%

Jack N. Earley of Radiation Safety [Williams]. This impact can be Associates, Inc. entitled, Professional expected to vary depending on the type of work, the work environment, and the Suicide: Disregarding the Respiratory ability of the individual worker to cope Protection Realities ,ofthe Revised 10 with respirator usage. If time and CFR 20. Much of this discussion is facilities are available, performing the sound thinking, *but once again, near the job on a mock-up both with and without end of the article the author repeats the respirators may be the best way to determine this factor.

25% number without any basis:

What would be the cost if you decided to put this worker in respiratory The 'Williams' reference quotes protection equipment to save that 50 Cardarelli's anecdotal mention of as high mrem? I've heard estimates of greater as 25%. But Morgan's article references than 25 percent loss of efficiency (you Williams as if the 25% came from a will want to perform your own tests for valid scientific study. This, as we know typical work in characteristic stressful environments - heat, radiation,. etc. - in now, is not true - it was merely mentioned as anecdotal information.

8

• Once a number appears in print and determine Joss (or gain) in worker begins to get repeated, it sometimes efficiency show expected findings.

That is, the effect of wearing a takes on the appearance of real data. respirator varies with a number of Interestingly enough, the 3% number did variables -- environmental conditions, come from a good scientific study that type of respirator, level of work (effort),

was done at Ontario Hydro about 1990. work duration, type of work, individual It was done on workers in a form of worker differences, etc.

supplied air suit - so that data was Therefore, it cannot be assumed that discounted and ignored. worker efficiency will increase if workers stop using respirators.

On January 1, 1994, the rules of game officially changed for respirator use Because of the many variables associated with respirator use for under jurisdiction of the Nuclear specific jobs, licensees may be found Regulatory Commission (NRC). Some using a range of efficiency factors.

licensees implemented the changes made However, in the absence of specifically to 10 CFR 20 earlier than that. applicable factors, licensees may use Significant among the changes was the default factors for each type of respirator. The following worker charge to licensees to ensure that they efficiency improvements resulting from.

maintained total effective dose removing respirators are documented 1n equivalent (TEDE) as low as is the literature (chiefly from military, and reasonably achievable (ALARA) while non-nuclear workplace studies):

working in airborne radioactivity areas.

RESPIRATOR TYPE RANGE(%)

This was certainly a good thing.

Negative pressure, full-face 5 -- 30 Part of the basis for this change was discussed by the NRC in section 04.03.d Supplied air, hoseline 15 -- 60 of their Temporary Instruction 2515/123 SCBA 40 -- 200 (NRC Inspection Manual) which was issued on March 15, 1994 and entitled, The use of an efficiency factor higher "Implementation of the Revised 10 CFR than those above should be technically Part 20". justified by the licensee.

04.03 TEDE/ALARA and Respiratory Everything about that is correct except Protection the numbers cited for respirator worker inefficiency. As it turns out, the basis

d. Review the licensee's implementing for these numbers is only anecdotal.

procedures.

There is no hard documentation of In the process of balancing the external scientifically produced numbers in the and internal worker risks, licensees will ranges cited in the literature - from any usually assume some Joss of worker source.

efficiency when wearing a respirator.

While changes in worker efficiency are Associated with this change was a major ideally determined empirically by the culture shock for many of the so-called use ofrealistic mockups (this is not required), literature searches of "radiation workers" who, along with workplace respirator studies designed to much of the entire workforce in this 9

• country are aging - they have been nuclear power plant. Federal inspectors around for quite awhile now. Lots of say that a pipe burst at the Dresden plant last January, spilling fifty-five workers, both utility employed and thousand gallons of water into the contractor have been working for a long basement of the building that houses the time. And, for the previous several reactor. (Visual of Commonwealth decades had become very accustomed to Edison plant in Morris, Illinois.) The wearing respirators and other protective reactor has been shut down since 1978, and the NRC says the leak did not pose clothing as a matter of routine in areas of any health dangers to anyone. The nuclear power plants where known or commission is faulting Commonwealth suspected surface or airborne radioactive Edison for not paying closer attention to contamination may have been. the plant's stability.

And Dresden is not the only Along with the aging process, I can tell plant in the news tonight. There are you from my owri perspective, it new and pretty serious questions being becomes harder to accept any change - raised about the nuclear plant in Zion.

especially when it seems to contradict How safe is it? Fox News has learned everything we have been told and have exclusively that the federal government is right now investigating charges by experienced. So, perhaps some of the some workers in that plant that Con Ed resistance to change is just organic. In may unnecessarily exposing them to this case, where workers were told, radioactive contamination.

almost overnight in some cases, that jobs David Johnson (Zion Plant Employee):

that always required respirators now all Commonwealth Edison is practicing the of a sudden do not - there was resistance. policy of forcing the people to go into Another facet was perhaps that of an environment that they feel that their employees tending to be a little leery of health is risked. (sic) anything employers say or do, especially when it relates to some activity that is Jacobson: David Johnson works at Zion. He says he is afraid for his life.

going to save the employer money - and The same for Mike Nabbitt, afraid especially when it is a health and safety enough, he says, to be thinking about related matter. quitting.

One of the situations that arose occurred Mike Nabbitt (Zion Plant Employee):

don't want to work somewhere where at the Dresden Nuclear Station in my health is put at risk, in the first Dresden, Illinois. The Commonwealth place. So if it's going to cost me my Edison plant was the subject of a feature job, so be it.

aired by WFLD-TV, Fox 32 News in Chicago. The following is a transcript Jacobson: He's also afraid of being fired for talking about being afraid.

from part ofthe April 18, 1994 Whatthey are worried about are these broadcast: respirators that the company is now taking away from them. (Visual of Walter Jacobson, anchor: respirator) A new policy to restrict the use of respirators because, says Con Ed, Tonight, the Nuclear "it is possible a respirator may decrease Regulatory Commission is taking a efficiency, cause you to work more closer look at the state's most troubled slowly, and thereby, in fact, increase 10

• your exposure to radiation." (Graphic of quote) Not so, says Mike.

Nabbitt: Without a respirator on, you can't see, smell or taste radiation. And a person that doesn't know what's going Johnson: It's gotten to the point of domination, "You'll do it or we'll get somebody else to do your job." In fact, that's - those were the words ofmy general foreman.

on or can't see, they're going to be Jacobson: They both say that's how it moving slower and more cautious to works at Zion, and from their point of make sure they're not going to stir up view, it's becoming increasingly the contamination and receive it dangerous in there.

internally. A person wearing a respirator won't have that concern, Johnson: In fact, I can remember in the they'll just move about freely. old days, remember seeing people up there, and it was, you know, big gossip Jacobson: Johnson and Nabbitt have to hear that somebody got internally complained to the NRC, the Nuclear contaminated. Where now, it's, you Regulatory Commission in Washington. know, we're talking two or three people And a few weeks ago, NRC officials a week that I know of.

came here to Zion to talk to Johnson and Nabbitt and others. (Visual of Zion Nabbitt: Yeah, you're talking zero in plant) eight years to two dozen in two months ..

• Nabbitt: They looked into it right Jacobson: It is important to add some away. Told me I had a legitimate perspective to this story now, which is complaint, and that, that was a concern. that a clear and present danger of contamination at the Zion plant has not Jacobson: Concern that working been proved by those workers there.

without respirators in there may be Con Ed says it would not take away the dangerous, and the NRC has other respirators if that were dangerous. The concerns as well: Is Con Ed being NRC says it's checking it all out, and honest with its workers at Zion; how will have a judgment later this week.

did Con Ed determine the respirators decrease efficiency? Now, on the matter of how Con Ed is handling its workers fears Johnson: They never once consulted about those respirators? It's fair to say with the workers, never once. And to there's no need to check that all out. In me, that's the worst thing. We're the the three weeks I've been working on_

experts on the job. Why not come and the story, I've discovered that when it ask us, "Will the respirators slow you comes to the fears about the respirators, down or not?" Before now we could go Con Ed just couldn't care less.

in, work as fast as we want, we didn't have to worry about airborne Pretty dramatic stuff, eh? Well, such_

contamination, because the respirator television spots are sometimes - well, protected you. To me, it's a piece of safety equipment. We have signs you know. However, the point is that around saying, "you are responsible for the change that was taking place was you own safety," and why not let us be met with resistance. Each power plant responsible for our own safety. had its own experience. I personally heard reports from respirator program Jacobson: "Let us wear these supervisors from dozens of facilities and respirators," they say, "or at least talk to us about our fear of not wearing them." their experience ranged from having a

• transition as smooth as butter to major 11

revolt. All agreed though that the key to making the change was through training and educating the workers and through time.

feasible or practicable. We are supposed to use process or other engineering controls, increase surveillance, and limit worker exposure times before assigning respiratory protection devices. More emphasis should be given to actually trying to In the July/August 1994 (Vol.I 1, No.4, pp 70-74) issue of Radiation Protection comply with this directive. Limit the use of respirators and employ Management, in an article entitled, engineering or process controls Respiratory Protection and Worker wherever possible. If airborne levels Efficiency -A Review the author, Gary S. permit, consider doing the job without Kephart of Clinton Power Station, respirators. In some cases, such as high continues the rumor about the number radiation areas, avoidance of respirator use may lead to a more rapid task 25%. First, in the Abstract: completion, thereby limiting the total exposure (both internal and external) to

... This article summarizes some aspects the worker. The small amount of of the industrial hygiene literature internal dose received may be offset by whic:h 1) suggest that 25 percent loss of the reduction in time spent and

• efficiency is typical... subsequent dose received from exposure in a high radiation area.*

Next, in the article itself, under the heading The Best Guess ofBetter Health Again, there is no mention of numbers Physicists: like 20% or 25% or any other specific Several recent articles in the health physics literature [l, 2 ,3] have discussed this "inefficiency factor" or "respirator decrement" and recommended estimates of 20 to 25 percent increase in task values.

A little further on in the 1994 article, the author states:

The purpose of this review article is to performance duration.

encourage pursuit of these efforts with an awareness of the previously Ironically, reference 3 cited above is an published research on this subject.

article from the July/August 1989 These days all ofus seat-of-the-pants (Vol.6, No.4, pp 49-53) issue of health physicists are often asked to -

Radiation Protection Management that I produce the documented technical bases

[sic] for our actions. In this co-authored while employed by the environment, it might be hard to magazine's new publisher. The implement and initial 25 percent following excerpt comes from that inefficiency estimate (pending its article: refinement through experience) if its only basis was "tribal knowledge."

Fortunately, there is abundant published The use of respiratory protection literature that suggests the 25 percent equipment can be a serious strain on the estimate for respirator induced wearer. There are a few ways to inefficiency is entirely reasonable and combat some of this stress, as well as a defensible.

few considerations to avoid it entirely.

All regulations and guidance tell us to avoid the use of respirators wherever 12 Interesting choice of words -

"suggests ... estimate".

• In Kephart's Epilogue (give me a break, Epilogue?) the stage is set for another irony in this soap opera:

Power Research Institute (EPRI) to evaluate the effect on worker efficiency

• while wearing full facepiece air-purifying respirators did indeed get done. The study showed that workers' While this article was in the review- performed the tasks from 1% faster to publication cycle, the author became 7% slower when wearing respirators.

aware of a utility-sponsored effort through the Electric Power Research In a June 1996 Nuclear News article Institute (EPRI) to evaluate respirator impacts on worker efficiency. The entitled, "Respirators, internal dose, and mock-up study, targeted for the fall of Oyster Creek" there appeared a pretty 1994, will utilize an environmental typical presentation on this subject chamber and nuclear workers at matter. Some of what was said in this General Public Utilities, and build upon article is troubling.

a previous study performed by Yankee Atomic Electric. Both the proposed EPRI study and its YAE predecessor It is worth noting up front that I have are outgrowths of the Three Mile Island personally had the experience of having **

study mentioned in this article - in that . been interviewed by telephone for an Ron Cardarelli of YAE has been a primary investigator in all three. The article written by a staff writer at one of article has cautioned that there are the major industry publications that innumerable variables and potential resulted in no end of misery. The confounding factors affecting the quality of such articles, technically, is design of a mock-up experiment. subject to the whim and subject Nevertheless, this third-iteration study, with EPRI backing and a multi-utility familiarity of the given writer. There are steering committee, is the industry's often misquotes and misinformation - it best hope for quantification of the happens all the time. Some English inefficiencies attributed to respirator major that couldn't get any other job usage in the nuclear occupations. goes to work for an editor and gets a writing assignment. They get on the Isn't it odd that there was such phone and find "experts" on their anticipation that this study would assigned topic, sometimes they actually produce the numbers needed to get make a site visit and do investigative people out of respirators - numbers in the . reporting, they plug in a few file photos 20% to 50% range. And then, when it (often with pro blems of their own) - and turned out that the study showed a small they bang out an article to fill a space decrease in worker efficiency - the study and meet a deadline. Rarely, do the is downplayed as being flawed in its interviewed parties have an opportunity design - therefore not producing usable to review the article before it gets numbers because of the non- published. So I do not point the finger representative conditions. of blame at the gentlemen that was interviewed - I have no way of knowing The study, "Effects of Respirators on what he actually said or thought.

Worker Efficiency" (EPRI TR-105350,

• Project 3099, Final Report June 1995) which was sponsored by the Electric 13 Nevertheless, this article did get published, and presumably people in the

industry read it and may have used the interestingly enough - when the author information it contained. The article did not have anyone to quote on this .

(like all other articles, including mine), statement - he just created a statement in with all of its good points and its bad quotes and attrtbuted it to common~peak.

points, its insightful passages and its The article continues:

misinformation is now "out there" - it is published "in the literature" - it may be But EPRI's study, "Effects of used in research by another writer and Respirators on Worker Efficiency,"

which was conducted last year at Oyster bits and pieces culled and cited and built Creek in an environmentally controlled upon Gust like the article you are now chamber to quantify estimates for the reading does). And it certainly is industry, showed that for two available for others in positions of maintenance tasks - bolt torquing and a responsibility to look to for guidance. manual dexterity test - the savings in dose and time was. less than anticipated when comparing respirator wear to Well, specifically, in the article the nonrespirator wear. The results of20 author talks about the respirator workers performing the maintenance reduction effort at Oyster Creek. He tasks showed that "the mean percentage also talks about a study that had been difference in time to complete a strenuous task with a respirator was done on-site in the previous year by the between one percent faster to five Electric Power Research Institute (EPRI) percent slower," the study said.

- the one in which Ron Cardarelli was the principal investigator. The article As EPRI pointed out several times in revolves around an apparent interview the text of its study, however, the two specific maintenance tasks were with Oyster Creek's Director of conducted in controlled and safe Radiological Controls, Roger Shaw. In conditions, and they were not designed part, the article states: to be representative of work performed by teams where worker communication While the premise of not wearing was ess\:ntial for task completion.

respirators to save dose is sound, the Actual plant conditions and tasks can analysis to do so shows it is still a skew the results, said Shaw, who was difficult decision. A study done last on hand to view the EPRI tests at year by the Electric Power Research Oyster Creek. "There are variables _*

Institute has shown that dose savings in involved," he said. "You have to take the respirator versus nonrespirator into consideration the time involved for debate. may not always be as great as a job, the accessibility to the workplace, _

thought. Nuclear plants have often if it has a high dose rate, and, very calculated an expected dose number for important, the physical impact that a typical job. In the past, that estimate wearing a respirator will have on an might have said, for example, "If you individual."

do the specific job without a respirator, the job will run approximately 25 Another media account, this time a small percent faster than with a respirator, article that recently appeared in The thus a dose savings." Boston Globe on November 13, 1996 was headlined: 2 at Conn Yankee to be Here is a perfect example of how this

• tested for exposure:

25% number keeps getting mentioned without any basis in fact. Also, 14

• Two workers at Connecticut Yankee nuclear power plant may have inhaled more than their annual limit of radiation in just 20 minutes earlier this month when they stirred up highly contaminated paint dust.

And of course, there have been other incidents that have occurred not mentioned here - some insignificant, some not so insignificant. The point is, people are being exposed internally in many cases where there is not TEDE Northeast Utilities, owner of the

• ALARA justification.

Haddam Neck, Conn., plant, has hired two health physicists from the Another ramification of this change has University of Massachusetts at Lowell to determine how much radiation the been the variety of ways people have workers absorbed on Nov. 2 when they found to deal with facial contamination.

collected radioactive paint chips by In the absence of respirators, the hand and did not wear respirators. workers' faces are now exposed to contamination as they were not before. If "They shouldn't have been doing some of the work they were doing and at least surface (smearable) radioactively one of them was walking in an area he contaminated material contacts the face shouldn't have been," said spokesman there is some risk of direct ingestion Neil Sheehan of the Nuclear Regulatory and/or inhalation. When we had people Commission. He said respirators would in respirators this potential was typically have greatly reduced the amount of radiation the workers ingested. not a concern. However if something brushes against the face, or splashes on, The NRC estimated the workers could

• or just deposits on from airborne have inhaled enough alpha particles of activity, or through what we characterize radiation to expose their bones to 50 as poor work practice - the worker rems of radiation over 50 years as the particles pass slowly through their touches his own face with a bodies. Such exposure would increase contaminated hand or arm, facial their lifetime risk of cancer. However, contamination may result. This may or Clayton French, one of the Lowell may not be a real problem. Most health physicists, said the workers instances of facial contamination are showed no signs of radiation sickness and predicted the increased risk would readily dealt with and are ofno be small. consequence. There can however, be some very troublesome cases.

The workers were exposed when they entered a part of the reactor containing Various power stations have been very loose surface radioactive contamination, NRC officials said. They scraped paint creative in coming up with "facial PCs" and debris from the surfaces, stirring or protective clothing for the face. The radioactive dust into the air.

• list of contraptions is long: ninja hoods with goggles, ski masks, disposable face Exposure-measuring devices they wore shields with dust masks, full face showed less than one third of a rem of radiation on their skin, far below the 5 shields, painters masks, surgical masks rems per year limit set by the NRC. But w/ safety glasses, bubble hoods modified what they had ingested can't be with filtered air blowers, etc., etc. In measured so easily, prompting an NRC cases where respirators are modified or investigation.

non-NIOSH approved respirators (some dust masks and surgical masks) are used 15

in this application, I believe it is bit of a stretch of the imagination. What are they being used for? Some would say just to protect the face from contamination. Well, yes I see that this an attempt to get the numbers back up?

No! Not at all. It simply is an appeal to make sure that these numbers and the cost savings associated with them are not unduly influencing decisions about when would be the case - but, isn't it also true to wear respiratory protection.

that some of these devices are also providing respiratory protection? I cannot argue against the fact that dose Certainly they are. Then the argument is dose - it surely is, whether external or comes that since a respirator is not internal. However, I can argue against required, you do not have to use NIOSH internal deposition, whether ingestion or approved equipment. Only the NRC and inhalation when it is avoidable and is DOE have yielded on this point. OSHA still consistent with the ALARA has stated many times that whenever concept.

respirators are provided or used they must be NIOSH approved.

This article is not written with the intent of damning the net effect of what has taken place or anybody involved in that If, for example, an operator has to walk into a room or area with a given external dose rate, where there is known or suspected potential for airborne exposure of radioactive material to make an effort. Blame is not the motive. It is observation, can we really justify written in the spirit of continuing claiming that his time in the area will be assessment of what the right thing to do increased by 25%, or any other assumed is - related to respirator use in number? I would argue that examples radiological environments. It is not this like this (and I believe there are many of author's belief that we should return to them) are cases where the industry has the old ways of issuing respirators - far become a little overzealous in keeping from it. Most of what has happened is a people out of respirators. Is it really good thing. Contrary to my obvious bias ALARA to allow someone to breathe in of being in the business of providing radioactive material (no matter how training and consulting services in miniscule) because it saves money?

support of respirator use, I have always Where is the scientific evidence that felt that there has been a rush to use shows that walking into a room and respirators and too little effort made at taking gauge readings or observing the avoiding their use through engineering operation of a pump or system will be controls of all description. However, I measurably hindered or slowed while do not beli~ve that we should stop using wearing a respirator. In fact, a recent respirators based on misinformation or- study published in the American with the primary motive being cost Industrial Hygiene Association Journal savings. (Vol.58, No.2, February 1997, pp 105-109) by David M. Caretti of the U.S.

Where we use to see thousands of Army Edgewood Research, respirators used per year at a nuclear Development and Engineering Center power generating station, we may now showed no cognitive effects from see less than 50. Is this article written in 16

• • respirators for low stress jobs performed for up to 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />.

The results of this study suggest that respirator wear over a relatively long reasons. But I believe that most significant of all has been the dramatic decrease, industry wide, of contamination levels and areas in nuclear power plants, in some cases by more time period in the absence of other than tenfold. I believe that the cleanup stressors should not significantly inhibit that has taken place over the last ten to cognitive functions as measured by reaction time. Therefore, decreased fifteen years is extremely commendable performance of workers wearing and is primarily responsible for the respirators while executing tasks such success of the respirator use reduction as display monitoring, computer effort.

operation, or surveillance - tasks requiring minimal physical activity -

does not appear to be caused by The bottom line is, if an entire industry -

detrimental cognitive effects imposed especially the nuclear industry, is going by a respirator. Whether observed to take such dramatic and sweeping cognitive performance during mask action related to occupational exposure wear would be observed in wear trials of employees, then it should not have a of longer than IO hours still needs to be determined. However, in practice it significant part of the basis for that seems unlikely that continuous action a multiplier in a formula that has respirator wear oflonger than IO hours such little basis in scientific fact. There would occur for operations other than is not a single study, of any credible military engagements.

quality that provides respirator wearer efficiency reductions anywhere near the It is a little troubling to see how the values that have been talked about and dramatic respirator reduction has been are in use today. SHOW ME THE bragged about just like the number of NUMBERS! We need more research- a days it takes to complete an outage. The tired but true statement.

feeling conveyed by some in the industry is that it's "fashionable" to reduce the That's just my opinion, I could be wrong.

number of respirators used in an outage -

it's like a competition between utilities -

just like with outage duration. I have not seen it or heard of it, but it would not surprise me to learn that there have been signs erected along site access roads rejoicing the low number of respirator hours maintained much like the number of days without an accident or the number of days till outage completion. I am sorry, but this is not the appropriate mentality.

Well if what has been done is so wrong,

• why haven't we seen more problems? I believe that there are a number of 17

EDITORIAL A portion of Appendix E: Questions and Answers for PRCS Standard Let One Slip By!? Clarification, Section K - Rescue Service, containing question 3 and its Sometimes in the business of answer/discussion are reprinted on the occupational health and safety next two pages (19 & 20). (Readers may consulting, it happens that something of find that the rest ofthis commentary makes more significance slips by you - well, I have sense upon first reviewing those two pages.)

become aware of one of those events.

I was very surprised to see that OSHA Applicable for activities that fall under was apparently allowing the use of a the requirements of29 CFR 1910.146, respirator in a situation for which it may OSHA's Permit-Required Confined not be NIOSH approved.

Spaces (PRCS) Standard, there is a peculiar twist on the requirements for

• I believe that the position in this respiratory protection. I *am embarrassed to say that I was completely unfamiliar with it. A recent telephone inquiry from a client brought me up to speed.

Questions about the need for a specific interpretation was taken in light of the fact that there are many entranceways to confined spaces that are very small and otherwise restricted - making it difficult, if not impossible, to pass through them type of respirator involved with a while wearing a self-contained breathing apparatus (SCBA) with a standard 30 or confined space situation ensued. At first, I did not have a clear understanding 60 minute cylinder. Though my reaction of exactly what their concern was, nor is generally, "make the hole bigger", I do which document they were referring to, understand that this is often not possible.

so they faxed me a portion of it. Something must be done to do the job.

Unbeknownst to me, way back on May One way that I have heard that people 5, 1995, the Directorate of Compliance are dealing with this difficulty, that is Programs issued OSHA Instruction

• absolutely unacceptable, is to allow 2.100, Application of the Permit- entry without the cylinder and/or SCBA Required Confined Spaces (P RCS) on and have it passed through the Standard, 29 CFR 1910.146with its opening behind you. Nor is acceptable stated purpose: to just carry or drag the cylinder with This instruction established you instead of wearing it in its harness.

enforcement policy and provides explanation of the standard to ensure Assuming that the physical uniform enforcement. circumstances necessitate it - what is suggested in this OSHA interpretation And a scope that says:

This instruction applies OSHA-wide.

seems reasonable from a practical standpoint, provided all three of the This 7 page document has an additional stated minimum conditions are complied 39 pages of appendices covering a range with - AND - that people understand that of interpretations including some on respiratory protection.

18 you cannot use any respirator in

• violation of its NIOSH approved

.OSHA Instruction CPL 2.100 MAY 5 1995 .

Directora~e of Compliance Programs

3. a Would a rescuer entering an J:mmediately Dangerous to* Lif ,*-i..1r*:*~--

and Health (J:DLR) atmosphere using a supplied-air respirator in combination with SCBA (escape bottle), be in violation of OSHA regulations1 Yes, however, under the conditions addressed below, the violation can be considered as de minimis.

The PRCS standard because of its perfornance nature does not specify the personal protective or rescue equipment necessary for rescue. The OSHA standard for respiratory protection is 1910.134. currently paragraph 1910.134(e) (3) (iii) requires, when an IDLH atmosphere exists, * * * . A standby man or men with suitable self-contained breathing apparatus shall be at the nearest fresh air base for emerg~ncy rescue.

The 1910.134 standard published in the June 27, 1974 issue of the Federal Register was derived from a now out-of-date voluntary standard (ANSI consensus standard ZSB.2-1969).

The most recent (1992) version of this same ANSI standard for respiratory protection for working in IDLH conditions has been changed. The new change specifies either a SCBA or a combination supplied-air respirator with SCBA for IDLH conditions.

It is OSHA policy to accept compliance with a provision in a current national consensus standard (ANSI) which provides an

• equivalent or greater level of protection from the hazards.

A rescue service can employ the use of supplied-air respirators in combination with self-contained breathing apparatus (SCBA) when conducting rescue operations. If a rescue service employer chooses to use combination supplied-air respirator with SCBA over the SCBA specified in the r~spiratory protection standard 1910.134(e) (3) (iii), for permit-required confined space rescue, the violation will be considered as de minimis as long as the following minimum conditions are also employed:

1. An evaluation of the permit space t.o be entered has been done to determine which appropriate respiratory protection (SCBA or Supplied-air with SCBA) is best suited for the rescue.

2* The rescuer's respirators and air source meet the requirements of the 1910.134 standard.

E-18

OSHA Instruction* CPL 2.100

• MAY 5 1995

• Directorate of Compliance Programs 3* The air source for the rescuer* s respiratory protection ,,

• is independent .from that which is being used by the authorized entrants.

We also would recommend the following policies and work practices for the rescue services which choose the supplied-air respirators with SCBA op~ion:

a. Establish a policy requiring immediate withdrawal from the space whenever a respiratory protection problem develops.

b. Establish a policy for use and training on emergency air line sharing "buddy breathing".

c. Ensure that the rescuers wear full body harness and use life lines whenever practical.

d. Establish a policy requiring a. minimum capacity of the source air to be twice (2X) the volume of the total needs of all rescuers connected to it for the anticipated duration of the rescuer's entry.

e. Establish a policy which mandates a minimum team of two rescuers for all permit space rescue entries.

• r E-19 *

• conditions of use. This point is not expressly clear in the OSHA document.

It is noteworthy that OSHA does not state that this practice is limited to those questions. For example, What type of combination supplied-air respirator with SCBA? I believe, when this was written, we assumed that it was understood that the conditions of situations where a small opening approval of such devices would be necessitates something that is smaller adhered to. That is, that such devices than a standard SCBA - it seems to allow with less than a 15 minute service life such practice for any confined space rating on the self-contained air cylinder rescuers. And please note that all of this could not be used for entry into IDLH applies only to rescuers - not the original while breathing from the cylinder. And entrants. further, that devices with a self-contained air cylinder having a service If I am interpreting this compliance life rating of 15 minutes or longer were directive correcting, OSHA has based its

• limited to entry while breathing from the position on changes in language that cylinder for no more than 20% of the appeared in ANSI Z88.2 - 1992 cylinder's rated service life.

regarding respirator use under IDLH conditions: Also, though the ANSI language is admittedly open for interpretation, I do 7.3.2 Respirators for use under IDLH not believe it was intended that the conditions at normal atmospheric standby person(s) had the same options pressure. for respirator use as the primary respirator wearer (the entrant).

The required respiratory protection for IDLH conditions caused by the presence of toxic materials or a reduced But be assured, I will bring this issue up percentage of oxygen as described in at our next meeting of the current conditions (a), (b), (c) in 7.3.1 is a subcommittee working to revise the positive-pressure SCBA or a Z88.2 document once again.

combination of supplied-air respirator with SCBA.

Well, I was a little puzzled and _

When respirators are worn under IDLH concerned about what OSHA was saying conditions, at least one standby person in their instruction - and the way it may shall be present in a safe area. The be interpreted, so I telephoned John standby person shall have the proper equipment available to assist the Steelnack at OSHA and queried him respirator wearer in case of difficulty. about this issue. He advised that prior to Communications (visual, voice, signal the issue of this document, in their work line, telephone, radio, or other suitable on revising 29 CFR 1910.134, they were means) shall be maintained between the standby person and the wearer.

anticipating language that would allow such practice - without any restriction on That does not say what I see OSHA the service-life rating of the breathing air saying in their Instruction. Though, I cylinder which would be part of such a admit that the language in the ANSI combination respirator. I expressed my standard leaves the door open to some dismay and concern that such an

• anticipated use would be in contradiction 21

of the devices' NIOSH approval unless EXTRA FEATURE the cylinder had a service-life rating of 15 minutes or longer and that it would JUST ANOTHER RESPIRATOR?

not be anticipated that more than 20% of that rated service-life would be Where there is a will there is a way.

consumed during the entry portion of the Where there is a need, there is a product.

rescue. He seemed to agree that this That is that way it seems with an would have to be fixed. Unfortunately, increasing number of products making since there was no comment submitted . their way into the marketplace.

regarding this issue during the period Nowhere is this more true perhaps than that the docket was open to receive such with devices being called RPEDs, comments on the revision to .134, it may Respiratory Protection Escape Devices.

be difficult to change it. We will have to wait and see what they do. Because the National Institute for Occupational Safety and Health's Bottom line - I believe both Z88.2 -

1992 and OSHA Instruction CPL 2.100 could be clearer on this issue. It must be understood that NIOSH approval conditions must take precedence in any (NIOSH) existing testing and certification regulation, 42 CFR 84, does not have provision for evaluating or certifying such products - they cannot become NIOSH "approved". This does respirator selection or use. not necessary mean that they are not good products, it simply means that they do not fit into any existing category. My

. guess is that some of the products on the market are good, some are adequate, and some are not so.

In some cases, the marketing and sales of some of the RPEDs seems to have at least bordered on 'selling to the fears'

• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • that people have about fire. Not that fire Respirator Support Services welcomes any isn't something to be afraid of - it is just materials for publication in RESPIRATORY that fear is not always the best incentive PROTECTION UPDATE. Feature Articles, or basis for purchases. The fear of being Technical Notes, Editorials, Letters to the Editor, News Releases, Calendar of Events items, unable to escape from a smoky burning Training Topics, or any other materials related to high-rise, airplane, train, cruise ship, the subject are requested. Your input is needed. nursing home, or any building or structure. There is a convincing

• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • . argument to be made about the number of people who might have survived any number of incidents over the years where smoke inhalation was th~ primary cause of death. I have heard, 22 anecdotally, numbers as high as 90%.

• This author's earliest encounter with this type of product was about 10 to 12 years ago at the annual American Industrial Hygiene Conference. There was actually an exhibitor set up in a booth at the trade intrigued - this thing actually looked like it had the potential for working. The sales literature offered the following

• description:

show demonstrating a "plastic" bag that Why wait for afire? Take control of was being sold as an escape respirator. your own safety now with the EVAC-U8 Emergency Escape Smoke Hood. It is This bag was rather large, and was the smoke and toxic fumes that kill in supposed to be made out of flame 80% of the I 0, 000 fire-related deaths resistant material. It was simply a bag each year. In less than 60 seconds, with a draw string incorporated. The your home can become impossible to salesman demonstrated one for me. He breathe in. And in an airplane. there is no safety device to put on. So, bring it tore open its storage pouch, unfolded the with you.

bag, snapped it vigorously so as to fill it full of room air and then placed the bag The EVAC-UB gives you breathable over his head and pulled the draw string filtered air for up to 20 minutes, to close the bag securely around his keeping smoke and deadly gases like carbon monoxide out ofyour lungs. Its neck. This product was being sold to Kapton hood also protects your head employers in, and owners of, high-rise and eyes. You can see all around you.

office buildings for their office workers Kapton resists 1500°F.

to use.

EVAC-UB is as small as a soda can, lightweight, easy to put on in seconds, The next product encountered was from and its glow-in-the-dark bottom helps the Jalypso Marketing Company. I saw you find it and others find you.

it featured in the New Products section Replacedfree if ever used in a fire.

on page 4 7 of the May 1992 issue of Five year guarantee.

Professional Safety (the official Price... $59.95 + $5.00 shipping and publication of the American Society of handling Safety Engineers).

Another product is called, "Smoke The Jalypso Smoke Filter, a safety-orange cloth bag that, when worn over Escape Emergency Respirator" and is

• the face, filters smoke as it passes described as follows on the internet.

through. The filter is filled with specially coated materials that trap A self-rescue device, allows users to smoke particulates, making it easier to escape fire or smoke emergencies. The breathe. An elastic strap holds the bag transparent, heat-resistant hood unfolds in place to free hands during escape from a matchbook size package to from smoke-filled areas. protect users' eyes, nose, and mouth from lethal smoke. A special ionized Sometime later, yet another product jilter blocks soot and smoke particles came to my attention: the EVAC-US 0.1 micron or larger. Hoods are constructed of. 002 mil optically clear Emergency Escape Smoke Hood. I random copolymer UL-rated VTM-0.

was really quite impressed with the The filter features patented tri-layer cleverness of the name. Upon receiving ionized construction. Buyers and a sample of the product I was also quite distributors sought.

23

Another offering found on the minutes from 98 percent ofthe toxic information highway: gasses created by fire, including chlorine, ammonia, hydrogen sulphide

[sic] and acrolein. One potentially The Xcaper Smoke Filter" is an deadly gas that Provita, which sells for internationally patented, laboratory $59.95 including shipping and tested product that can eliminate over handling, doesn't protect against, 95 percent ofsmoke particulates caused however, is carbon monoxide.

by common fires. The firm says that smoke particulate inhalation accounts for over 70 percent ofall fire-related deaths. The filter is tested and certified This same product is offered in another safe and saleable by the U.S. mail-order catalog, Magellan's Essentials Department ofDefense, NATO, the for the Traveller. The descriptive text is American Bureau ofShipping, and a little different however:

other organizations. Buyers, distributors, agents are sought.

"Until air!ines are compelled to provide smoke hoods for passengers...you will have to bring your own." (Ralph Nader, A catalog that was received via bulk Collision Course).

mail called the Self Care Catalog, along with bug bite proof shirts and UV ray You know how we feel about the value protection clothing offers an of emergency escape hoods for our customers who fly or stay in high-rise "Emergency Escape Smoke Hood". hotels (see page JO in our annual catalog). So we have added a third More than 80% offire-related deaths hood to our line - the new instant wear actually are caused by smoke and smoke hoodfrom Provita. With 360° chemically-poisoned air. Give yourself visibility, there's no pausing to find the and family 20 minutes ofevacuation front or "back", so donning it is a time with this smoke hood - its simple matter of tearing open the clear transparent, heat-resistant shield is gas- vinyl carrying pouch and pulling it over impermeable, with a 360° charcoal your head Automatically forms a snug filter and a rubber seal at the neck. seal at its neck opening - no straps or Proven to protect from smoke and 98% ties to slow you down. Made of heat-oftoxins created by fire, including resistant Kapton' polymide film that chlorine, ammonia, hydrogen chloride, extends protection to the_ wearer's full hydrogen sulfide, and acrolein.

• neck and shoulders, with a special Compact, lightweight, sealed package three-layer filter to remove hazardous can easily hf kept in briefcase, desk byproducts offire (including the eye-drawer, or handbag. One size. Made irritating smoke particles themselves).

in England Price... $69.00 Gives you those extra few minutes to escape that could save your life (or the Frequent Flyer magazine (July 1994, pg . life ofsomeone you love). A compact 5 x 6-112 x 3/4" in its pouch, it'll flt in

62) featured the exact same hood:

purse, pocket or briefcase. For one-time use. 5 oz. Made in England.

There's a new smoke hood on the Price ... $59. 00 market that could buy precious time in the event ofan air crash. The Provita From page 10 of Magellan's annual smoke hood, distributed by Santa catalog:

Barbara-based Euro Marketing, Inc.,

claims to protect the lungs for up to 20 24

We feel very strongly about the value of Fume Free Inc., P.O. Box 1680, Stuart, emergency escape smokehoods for all FL 34995-1680, (800) 386-3373 and is who fly. It comes from studying as feature on an internet website:

many ofthe reports on aircraft http://www.quickmask.com. Single unit "incidents" as we have, reading again and again how many lives might have price is now at $80.00.

been saved ifpassengers would've had just a few extra minutes to evacuate . Surely, there must be a number of other from the smoke and fumes that claim far similar products out there as well. And more lives than impact or flames. So obviously there must be a market for please think very seriously about making a compact smokehood a them. Consumers are of course free to permanent part ofyour travel gear, purchase whatever they wish. There are never taking it out ofyour carry-on no government restrictions on using this bag. type of product or any other respirator-like product.

We introduced the Israeli-made Duram Escape Hood in our Summer '9 3 Newsletter. It was an instant hit. Its One of the serious concerns with price, its compact size and the consumer use is that they may not take confidence the traveling public placed the time to read or adequately in it soon made it a very popular item here at Magellan's. The hood itself is understand, or always remember the constructed ofa heat-resistant important restrictions and limitations for polychloroprene latex material, soft and using such products. Sometimes the flexible, with a large, clear visor ofa . product manufacturer does a good job of special polyimide film (also extremely providing these instructions - and resistant to heat), and a unique, multi-sometimes they do not. Regardless, we layerfilter that removes the hazardous levels of such combustion by-products consumers don't always do such a good as cyanide, hydrogen chloride, job of paying attention to such things.

acrolein, smoke particles, and other toxic components. It is vacuum-packed These products are oo:t intended for entry in a very compact 4 x 5 x 1/2" easy-into hazardous environments. What will opening pouch, easy to remove and slip over your head if ever needed, forming happen to the person who, say, escapes a snug seal around your neck. A from a burning structure with this veteran ofmany live-fire product on and then decides to go back demonstrations that we at Magellan's in and look for others - or perhaps the have witnessed ourselves. For one-time use. (5 oz) Price... $59.00 family cat. What if they decide that: 'if the product can protect me in such a This product (which has been updated hostile environment as a smoke fire, then and upgraded) js now being marketed . why wouldn't it protect me against any under the name QUICKMASK as a other toxic gas or substance?'

Respiratory Protective Escape Device and is recommended for Self Rescue, Without NIOSH certification, employers Victim Rescue, and Health Risk who may be interested in utilizing any of Reduction for Military, Civilian, Law these devices are faced with a bit of a Enforcement, Security, Fire, Rescue, quandary. All of the health and safety EMS, and HazMat. It is available from regulatory agencies for all workplaces (OSHA, MSHA, DOE and the NRC) 25

require that when respirators are some speculation that a finished standard provided that they be either NIOSH

• may .be out in about two years. In fact, "approved" or otherwise [specifically] am told that this group is meeting in "accepted" by that enforcement agency. Vancouver on April 2 & 3, 1997 to put Even if there is a legitimate need for the finishing touches on. A point of such a product, the employer likes it's contact regarding this effort is:

features and wants to purchase and provide it - it is a violation of Federal Bruce Teele (and perhaps State) regulation without NFPA such approval or acceptance. P.O. Box 9101 Quincy, MA 02269-9101 The issues of design, materials, (617) 770-3000 construction, performance, and quality control in the manufacturing of these There certainly is good reason to have products are of concern. If indeed the some type of performance standard for product is made well and will serve a these products, they are currently being useful purpose, there should be a system

• used and likely will be a very hot under which it can be recognized as such product for American consumers, and will be able to help ensure that there employees, security forces, and military is a known minimum level of personnel. There is an increasing performance and quality. awareness of the potential for having to face the hazards associated with smoky The rest of the world seems to have fires but also with chemical releases and recognized this and done something unfortunately chemical and biological about it a lot quicker than we have. terrorism.

There is already a European standard (N403) covering these products. Also, the Japanese and Australians have their standards in place.

In this country, within the "respirator industry" specifically, some of the larger, conventional respirator manufacturers, the firefighters union, and others in this business have been interested in these things and some of the same problems discoursed above.

They have gotten together and have been drafting a consensus standard to help establish minimum criteria for RPEDs.

Apparently, the committee is essentially done with their writing and are in the process of trying to find a home for it -

perhaps with the American National Standards Institute (ANSI). There is 26"

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28

~lrrn USNRC NUCLEAR ENERGY INSTITUTE

'9B DC 19 Al l :o S Lynnette Hendricks DIRECTOR, OFF- - PLANT SUPPORT RlJt L . I E NUCLEAR GENERATION DIVISION ADJL1L* , ,L, ' .

October 9, 1998 Mr. John C. Hoyle Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATIENTION: Rulemakings and Adjudications Staff

SUBJECT:

Proposed Rule-10 CFR Part 20, "Respiratory Protection and Controls to Restrict Internal Exposures" (63 Federal Register 38511-July 17, 1998) and Draft Regulatory Guide GG-8022, Proposed Revision 1 to Regulatory Guide 8.15, "Acceptable Programs for Respiratory Protection" (63 Federal Register 40141-July 27, 1998)

Dear Mr. Hoyle:

The Nuclear Energy Institute (NEI)* submits these comments on behalf of the nuclear energy industry in response to the subject notices.

The Commission has specifically requested comment on whether the technical aspects of the rule should be addressed through alternative approaches other than the proposed rule, such as a performance-based rule with a regulatory guide endorsing ANSI standards. We support such an approach because it will provide greater flexibility to licensees and permit more efficient and effective regulatory response by NRC to future technical developments and changes in industry consensus standards.

This approach also better reflects the direction of NRC policy on performance-based approaches to regulation and the mandate of the Technology Transfer Act of 1996

• NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including regulatory aspects of generic operational and technical issues. NEI members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry.

OC1 2 1 998 Aeknowledged oy card .....- - . . . - -

1 776 I STR EE T . NW SUITE 400 WASH ING TO N . DC 20006-3708 PHO N E 202 . 739 8000 FAX 202785 . 4 019

Mr. John C. Hoyle October 9, 1998 Page 2 (Public Law 104-113), than does the proposed prescriptive rule. On the same basis, we recommend that draft regulatory guide (DG-8022) be revised to simply endorse relevant ANSI standards, noting exceptions being taken to the standards by NRC, and to retain guidance on assuring that exposures will be maintained as low as reasonably achievable (ALARA).

The proposed rule does not resolve inconsistencies between the regulatory requirements of the NRC (10 CFR Part 20) and the Occupational Health and Safety Administration-OSHA (29 CFR Part 1910) with regard to respiratory protection.

We recommend that the final rule clarify that licensee respiratory protection programs that comply with OSHA requirements also will be considered to be in compliance with NRC requirements with regard to the basic elements of an acceptable respiratory protection program. This will provide increased flexibility for licensees desiring to implement a single, common respiratory protection program to address radiological and non-radiological airborne contaminants and hazards.

With regard to NRC's planned revision to NUREG-0041, "Manual of Respiratory Protection Against Airborne Radioactive Materials," we suggest that NRC consider eliminating the NUREG. Most, if not all, of the scope of the current NUREG contains information that is redundant with what should be contained in the rule, the regulatory guide, and the relevant ANSI standards. The final regulatory guide and referenced ANSI standards should contain all of the relevant information needed by the licensee to implement an acceptable respiratory protection program.

We have enclosed specific comments intended to help improve the usefulness and clarity of the proposed rule and the draft regulatory guide. If you have any questions regarding these comments, please contact Ralph Andersen of our staff at 202-739-8111.

ut;,~

~Lynnette Hendricks Enclosure RLAftnb

Enclosure NEI Comments on Proposed Rule - 10 CFR Part 20, "Respiratory Protection and Controls to Restrict Internal Exposures" (63 Federal Register 38511 - July 17, 1998)

Section Comment General The Commission has specifically requested comment on whether the technical aspects of the rule should be addressed through alternative approaches other than the proposed rule, such as a performance-based rule with a regulatory guide endorsing ANSI standards.

We endorse such an approach because it will provide greater flexibility to licensees and pennit more efficient and effective regulatory response by NRC to future technical developments and changes in industry standards. This approach also better reflects the direction of NRC policy on performance-based approaches to regulation and the mandate of the Technology Transfer Act of 1996 (Public Law 104-113), than does the proposed prescriptive rule.

Specifically, we suggest section 20.1703 should be revised to require that "the licensee shall implement and maintain a respiratory protection program consistent with ANSI Z88.2-1992, American National Standard for Respiratory Protection, as endorsed with exceptions in Regulatory Guide 8.15" (or similar wording). Much of the technical details in this section of the proposed rule regarding a respiratory protection program could be deleted because they are redundant to the criteria and the standards in the regulatory guide.

The final rule should retain provisions specific to protection against radiation and radioactive materials that are not within the scope of the ANSI standard and provisions that address application for use of higher assigned protection factors.

General The proposed rule does not resolve inconsistencies between the regulatory requirements of the NRC (10 CFR Part 20) and the Occupational Health and Safety Administration - OSHA (29 CFR Part 1910) with regard to respiratory protection. We recommend that the final rule clarify that licensee respiratory protection programs that comply with OSHA requirements will also be considered to be in compliance with NRC requirements with regard to the basic elements of an acceptable respiratory protection program. This will provide increased flexibility for licensees desiring to implement a single, common respiratory protection program to address protection against radiological and non-radiological airborne contaminants and hazards.

Enclosure Note: The following comments on the proposed rule should be applied within the context of Revision 1 to Regulatory Guide 8.15, if the cited sections are removed from the final rule consistent with our general comments on developmg a performance-based rule.

20.1701 Change "practicable" to "practical" to be consistent with other sections of Part 20.

20.1703(a) The phrase, "except as otherwise noted in this Part" (or similar wording) should be added to this section. This will help clarify, for example, that the use of continuous-flow, supplied-air suits is authorized as described in Appendix A.

20.1703c(5) Change "physician" to "physician or licensed health care professional" as defined in 29 CFR 1910.134. This help achieve consistency between NRC and OSHA requirements and eliminate unneeded restrictiveness in the regulation.

20.1703(f) The requirement that "standby rescue persons shall observe or otherwise be in direct communication with the workers" is unnecessarily prescriptive and may lead to adverse results. For example, such a requirement may lead to standby rescue workers having to be positioned in radiation areas that result in excessive exposure. The provision already includes a sufficient performance basis, i.e., "[standby rescue persons] must be immediately available to assist [the workers] ... " The prescriptive detail on how to accomplish this is unneeded and should be deleted.

Appendix A "Single-use disposable" respirators are included without an assigned protection factor. Footnote e clarifies that this type of respirator may be used under conditions in which no credit is taken for their use in estimating intake or dose. It is not clear if respirators used under these circumstances must be certified by NIOSH per 20.1703(a). This should be clarified in the final rule.

Appendix A The assigned protection factor 10,000 for self-contained breathing apparatus (SCBA) used in the pressure-demand (PD) or positive pressure, recirculating (RP) modes differs from that included in the ANSI standard. ANSI Z88.2-1992, Table 1, does not include assigned protection factors for SCBA used in these modes because "a limited number of recent simulated workplace studies concluded that all users may not achieve protection factors of 10,000." The ANSI standard suggests that for emergency planning purposes, "an assigned protection factor of no higher than 10,000 should be used." NRC should include a discussion of its rationale for departure in the proposed rule from the ANSI standard, or change or clarify the use of the assigned protection factors (e.g., in a footnote).

2

Enclosure Appendix A/ Footnote c contains an apparent typo that should be corrected. The Footnote c second sentence should be changed to reflect "APF > 100" to be congruent with the first sentence.

Appendix A/ The wording in Footnote h should be changed to "immediately Footnote h dangerous to life or health" for consistency with wording in ANSI standards and OSHA regulations.

NEI Comments on Draft Regulatory Guide GG-8022, Proposed Revision 1 to Regulatory Guide 8.15, "Acceptable Programs for Respiratory Protection" (63 Federal Register 40141 - July 27, 1998)

Pa2:e/Section Comment

• General Much of the guidance in the draft regulatory regarding the basic elements of an acceptable respiratory protection program simply restates what is in ANSI standard ANSI Z88.2- l 992. The guide should endorse the ANSI standard with noted exceptions and redundant material should be deleted form the guide. Guidance should be retained that addresses protection against radiation and radioactive material that is outside the scope of the ANSI standard.

General The guide should clarify that compliance with OSHA requirements with regard to the basic elements of a respiratory protection program will be acceptable to the staff as compliance with comparable NRC requirements.

Note: Many of the comments below would not apply if the two "General" comments on the guide are adopted. These comments are provided in the event that the current scope of the guide is retained (i.e., m case the "General" comments are not adopted) 8/2.3 The last paragraph in this section allows for licensees issuing respirators to workers upon request in accordance with applicable State OSHA regulations. The guide should that an ALARA evaluation need not be performed and documented under such circumstances.

8/2.3 and The guidance given in sections 2.3 and 3.6, regarding whether the use of 11/3.6 respirators is appropriate for contamination control purposes, appears contradictory. The wording in these sections should revised to clarify intent. We believe that the approach taken in section 2.3, allowing for such use, provides better flexibility to address worker comfort, health and safety concerns, and should be retained.

3

Enclosure 10/3.3 The intent of this section is unclear. As written, the guidance appears to be inconsistent with requirements in Part 20 for monitoring, assessing, and recording individual dose from intakes, for example, 10 CFR 20.1502. This section should be revised to more clearly reflect Part 20 requirements, or it should be deleted.

12/4.3 This guidance given in this section is for routine use respirator facepieces stored in clear plastic bags is that they be handled and examined monthly. It is not clear what is intended by such a cursory inspection. Respirators that are cleaned, sanitized, inspected for defects, repaired (as needed), and then sealed in a plastic bag and stored properly (i.e., in accordance with ANSI Z88.2-1992, section 10.4) are unlikely to be damaged or deteriorate to any significant degree over time -certainly not to the degree that would be apparent in a cursory "handling and examination." Also, when issued, the respirator will be inspected and checked by the wearer prior to use. We suggest that the guidance be that such respirator facepieces in storage sealed in plastic bags "be inspected periodically." The period for inspection should be established by the program administrator based on experience.

12/4.3 This guidance given in this section is emergency respiratory protection equipment (SCBA) "be donned and operationally tested frequently (at least quarterly)."

Adequate operational testing of the equipment, e.g., as described in ANSI Z88.2-1992 (section 10.2), does not necessitate "donning" the equipment. Donning the respirator facepiece would likely require that it subsequently be cleaned, sanitized, and re-inspected, resulting in excessive wear on the equipment and unnecessary burden.

The suggested inspection frequency, at least quarterly, is inconsistent with ANSI Z88.2-1992 (section 10.2) and OSHA requirements (1910.134(h)(3)(b) which require inspection of emergency equipment monthly. Emergency use equipment (SCBA) has the high potential quick donning and use in IDLH areas. Therefore, we suggest that the frequency for inspection be changed to be "monthly."

21/5.3 Coaching and assistance may form an integral part of the fit-testing, which is recognized in the OSHA protocals referenced in this section of the guide. The purpose of the fit-test is to confirm the size and type of respirator needed by the wearer and the ability to obtain a proper fit and face-seal with regard to the assigned protection factor. This paragraph is not relevant (and may be contradictory) to that purpose and we suggest that this paragraph be deleted.

4

Enclosure 21/5.3 The next-to-last paragraph on page 21, beginning with the wording, "During training or operation ... " appears to be out of place within the guide, i.e., it does not directly relate fit-testing, the topic of the respective section. We suggest that it be relocated to a more appropriate section of the guide.

23/6.3 For clarity, this section should be revised to reflect its applicability to "suspect" areas. As written, the guidance may be inferred to apply to all areas that have not been assessed, including a large number of areas for which there is no reason to assume that hazards may be present, e.g.,

due to process or historical knowledge. We suggest that the section be retitled as "Unknown and Unassessed Areas," and that the first sentence be revised to read " ... the level of hazard is unknown and unassessed ... "

5

lSEA THE SAFETY EQUIPMENT ASSOCIATION 1901 North Moore Street, Arlington, Virginia 22209-1762 703-525-1695 fax 703-528-2148 e-mail isea@safetycentral.org www .safetycentral.org/isea

)> 0 October 5, 1998 ~o O .:r:i-n S::c ~

~

,_3FR. 3851/ f=

J r Rulemakings and Adjudications Staff Secretary, U.S. Nuclear Regulatory Commission

- ,,, 71

'J)

I c:::,

n

\0 I

Washington, DC 20555-0001  ::x:::,

\0 RE: Comments of ISEA, The Safety Equipment Association regard.in~ 10 CFR ~ t 20, Respiratory Protection and Controls to Restrict Internal Exposure' to Radioactive Material.

Dear Secretary:

ISEA represents the leading manufacturers of safety and health equipment. ISEA members manufacture more than 95% of all NIOSH certified respirators. We offer the following comments to the proposed revision of 10 CFR Part 20.

Section 20.1003, Definitions To make the terminology of the revised NRC standard consistent with current OSHA and proposed ANSI standard wording, change the word "disposable respirator" to read "filtering facepiece" and "Fit Check" to read "User Seal Check fit check".

The definition for fit test should be changed to "Fit test means a test, quantitative or qualitative, to evaluate the fit of a respirator on an individual and, in the case of quantitative testing, to determine a fit factor".

Section 20.1702, Use of other controls ISEA believes that guidelines for ALARA analysis need to be better defined.

Currently, there is a wide range of assumptions used in the industry when estimating the loss in efficiency resulting for the use of respirators. Recent studies indicate that these assumptions are incorrect. An EPRI study, "Effects of respiratory protection on worker efficiency", demonstrated that the loss of worker efficiency did not exceed 7%. This is contrary to current assumptions of 10% or more. We recommend that this standard require justification on ALARA programs that assume losses of worker efficiency greater than 5%. This will assure worker safety and is consistent with the NRC's desire to keep exposures ALARA.

Section 20.1703 Use of individual respiratory protection equipment This section discusses the removal of"facelets" in 20.1703 which we believe is logical. However, the NRC should provide a detailed description of products that meet the intent of the standard as well as a discussion as to how they differ from Supporting its members in manufacturing and marketing the highest quality safety and health equipment.

I 1998 Acknowledged b card ..- - - - - - - -

ISEA Comments to 10 CFR 20 other forms of respiratory protection. If the wording is not changed, there is the opportunity for "facelets" to be used that cause significant reduction in worker efficiencies, without the appropriate ALARA discussion. Many styles of facelets resemble respirators in every feature, with the one exception that are not approved by NIOSH as respiratory protection. In the absence of a third party approval, the NRC should take some responsibility to assure that these products have some minimum performance and quality standards.

Sec. 20.1703 ( c) (6) and Preamble page 38513 NRC states the licensee shall implement and maintain a respiratory protection program that includes, "Fit testing, with fit factor greater than or equal to 10 times the APF for negative pressure devices, and a fit factor of greater than or equal to 100 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 3 years."

ISEA believes that the frequency of fit testing should be at least once per year.

Although, we understand that in the case of protection from radioactive substances there are accurate means to determine exposure of an individual and therefore respirator fit is actually determined through a very indirect method, we maintain that the fit test must still be evaluated annually. Indirect means of determining fit and/or exposure should not take the place of fit testing. Taking such an approach diminishes the importance of respiratory protection in individuals and thereby engenders little confidence in their use.

Although we agree that the use of respiratory protection should only be used as a secondary means of protection, and that engineering and administrative controls should be the primary means of protection, when respirators are used they should be used with the intent of them providing the maximum level of protection afforded to them. By not performing yearly fit tests one cannot ensure that they are in fact providing the maximum level of protection they are intended to provide. An individual's condition can change substantially in a year or less and could dramatically effect the efficacy of a respirator. Such conditions are weight change, use of dentures, use of corrective lenses, psychological conditions, etc. A supervisor or even the individual wearer either may not be aware or consider that such changes may effect the fit and ultimately the efficacy of the respirator.

In addition, fit testing on an annual basis provides the wearer an opportunity to be retrained and reminded of the proper use of respiratory protection and also allows management to ensure that the respirator is being used properly. We therefore recommend that fit testing be conducted on an annual basis.

Section 1703 (g) and Preamble page 38514 NRC states, Whenever atmosphere-supplying respirators are used, they must be supplied with respirable air of grade D quality or better as defined by the 2

ISEA Comments to 10 CFR 20 Compressed Gas Association and endorsed by ANSI, in publication G-7.1, "Commodity Specification for Air," 1989, (ANSI-CGA G-7.1, 1989).

ISEA requests that the most current standard of ANSI-CGA be used. This is ANSI-CGA G-7.1, 1997.

Appendix A to Part 20 Air Purifying Respirators says "Single use disposable." NIOSH no longer has a designation for single use respirators. This should be changed to "Filtering facepiece".

Footnoted Appendix A to Part 20 and Preamble page 38514 In footnoted of the Assigned Protection Factors for Respirators, NRC states that "The licensee may apply to the Commission for the use of an APF greater that 1 for sorbent cartridges as protection against airborne radioactive gases and vapors (e.g.

radioiodine)."

ISEA believes that there is no justification why an APF comparable to what is provided for particulate respirators, cannot be assigned to radioactive gases or vapors with good warning properties when a chemical cartridge exists that is appropriate for that contaminant.

Footnote c of Appendix A Part 20 and Preamble page 38516 Footnote c states, "Air purifying respirators with APF less than or equal to 100 must be equipped with particulate filters at least 99 percent efficient. Air purifying respirators with APF less than or equal to 100 must be equipped with particulate filters that are at least 99.97 percent efficient."

We believe that the footnote is in error and should read, "Air purifying respirators with APF of less than or equal to 100 must be equipped with particulate filters at least 99 percent efficient. Air purifying respirators with APF greater than 100 must be equipped with particulate filters that are at least 99.97% efficient.

NRC also requires "at least 99 percent efficient". NRC offers no justification as to why 95% efficiency filters should not be used. ISEA believes 95% efficiency filtering respirators should be allowed and given an APF of 10, as this what is allowed by ANSI for any half mask respirator with a minimum filter efficiently of 95%. We see no reason to only allow a minimum of 99% efficiency since if a wearer passes a fit test with a 95% efficiency respirator they must achieve a fit factor of at least 100, and therefore can assume to have a protection factor of at least 10.

Footnote f of Appendix A Part 20 and Preamble page 38515 and 38516 Footnote f states "Under-chin type only. No distinction is made in this Appendix between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are acceptable so long as the seal area of the latter contains 3

ISEA Comments to 10 CFR 20 some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least 99 percent efficient and all other requirements of this part are met."

ISEA believes that quarter chin masks should not be categorically eliminated for use by the NRC. If a respirator meets all requirements including NIOSH certification and it has been determined that a particular device fits on an individual (through fit testing) then that device should be permitted for use. General statements as found in the preamble that a particular type of device exhibits "erratic" face sealing characteristics should not be made. The efficacy of a particular device on a specific individual can only be determined on a case by case basis through a comprehensive respiratory protection program. Those elements which include training a fit testing will determine whether or not a particular device is appropriate for an individual.

Additionally, ISEA believes that a half face piece disposable respirators without seal enhancing elastomeric components and are not equipped with two or more adjustable suspension straps should not be categorically discounted and effectively given an APF of 1. These respirators are half masks and provide the same level of protection as an elastromeric half face piece respirator with the required features.

If a respirator meets all requirements including NIOSH certification and it has been determined that a particular device fits on an individual (through fit testing) then that device should be allowed for use and given the appropriate credit for protection.

general statements as found in the preamble that "NRC believes that without these components it is difficult to maintain a seal in the workplace" should not be made.

The efficacy of a particular device on a specific individual can only be determined on a case by case basis through a comprehensive respiratory protection program.

Those elements which include training and fit testing will determine whether or not a particular device is appropriate for an individual. We don note that the NRC does give credit for those respirators that are fit tested to an APF level of 100 when the licensee performs the appropriate fit test. We do not understand why the NRC differentiates between these filtering facepieces and other half mask respirators when the result is the same. We believe that these respirators should not be treated in a different manner from other half face piece respirators.

ISEA appreciates the opportunity to comment on the proposed changes to the rule.

Please call me if I can provide additional assistance.

Janice Comer Bradley, CSP Technical Director 4

TSI Incorporated Tel. 800 926 8378 Health and Safety Instruments 6124902760 500 Cardigan Road Fax. 612 490 2704 DOCK ETED PO. Box 64394 E~ma il. healthsafety@tsi.com USNRC St. Paul. MN 55164 USA www http/(www.tsi.com TSI. -

9/30/98 U.S. Nuclear Regulatory Commission Attn: Rulemakings and Adjudications Staff Washington DC 20555-0001

• Re : Proposed revisions to 10 CFR Part 20 as described in F.R. vol. 63, no. 137, July 17,1998

DearNRC:

There are three issues concerning the proposed revisions to respirator fit testing requirements that TSI Inc. would like to bring to your attention. Both specifically involve paragraph 20.1703( c )( 6 ). The proposed paragraph reads :

(6) Fit testing, with a fit factor of 1 0 times the APF for negative pressure devices, and a fit factor 100 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 3 years.

Issue 1 - fit factor for positive-pressure full-face respirators:

A fit factor requirement of only 100 is too low for full-face tight-fitting masks regardless of their use with negative-pressure or positive-pressure respirators. TSI is in close contact with many of the thousands of organizations that have been using QNFT to fit test full-face masks. This experience spans more than a decade. We have never come across an organization that had difficulty achieving a fit factor above 1000 on most individuals. A fit factor of 100 on a full-face mask represents a very poor fit. The NRC should not allow anyone to wear a poor fitting mask under any circumstances. Positive-pressure is intended to elevate the protection level provided by a good fitting mask. It is not intended to compensate for the deficiencies of poor fitting equipment.

Issue 2 - fit testing frequency:

The proposal to replace the annual fit test requirement with one that allows up to 3 years between fit tests is based on the assumption that physical change to an individuals face is the only parameter that justifies a retest more frequently than every 3 years. In our experience, and the experience shared with us by our customer base, the primary benefit of an annual fit test is to refresh an individual's training. Having the proper size respirator is of little value if the equipment is not donned properly. Given the potential health hazard, annual fit testing can easily be justified based on the training issue alone.

Issue 3 - fit testing positive-pressure masks in negative- pressure mode:

It is an undisputed technical requirement that positive-pressure tight-fitting masks be fit tested in negative-pressure mode. This requirement needs to be added into the document. See ANSI Z88.2-1992 and OSHA 29 CFR 1910.134 for details.

Senior Product Specialist Member ANSI Z88.10 Respirator Fit Test Methods OC1 - 9 1998 Acknowtedged by card........ ... .... * * * ,,.. -

l) s UCLEAR REGULATORY COMMIS i I RULEMAKINGS&ADJUOlCATIO S SlA i:

OFFICE OFntE SECRETARY OF THE ISSION OocUnentSm

Commonwealth Edison <:ompany J .100 Opus Place Downers (;ro\'t:". IL (,OS l '1

@)

DOCKETED usrmc

• 9a OCT -5 P2 :19 ComEd October 1, 1998

. FF Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 t,,3FR3ff5II Attention: Rulemakings and Adjudications Staff

Subject:

Comments on Proposed Rulemaking, "Respiratory Protection and Controls to Restrict Internal Exposures"

Reference:

Volume 63, Federal Register, Page 38511 (63FR38511), dated July 17, 1998.

This letter provides the Commonwealth Edison (ComEd) Company comments on the subject Nuclear Regulatory Commission (NRC) proposed rulemaking published in 63FR385 l 1. ComEd generally supports the proposed changes with the exceptions discussed in the comments below.

General In the proposed rule's Federal Register summary, the NRC requested comments on whether the technical aspects of the rule should be addressed through other approaches. In response to that request, ComEd does endorse the development and use of simple risk-informed, performance-based rules. ComEd supports development of regulations and Regulatory Guides that directly endorse industry standards. These nuclear industry standards, in tum, need to be developed through nuclear industry participation.

Regarding the planned revision to NUREG-0041, "Manual of Respiratory Protection Against Airborne Radioactive Materials," consideration should be given to elimination of the NUREG. The information contained in the current NUREG-0041 is in many cases redundant with the type of information found in other industry documents such as American National Standards Institute (ANSI) Standard 288.2-1992, "American National Standard for Respiratory Protection." If certain aspects of the NUREG are considered crucial by the NRC in terms of respiratory protection-related guidance, then those few items should be added to the Proposed Revision 1 to Regulatory Guide 8.15, "Acceptable Programs for Respiratory Protection." ComEd believes this approach would be consistent with the strategy of formulating a more simple regulatory oversight process, that is, OCT - 7 1998 Acknowledged by card ........- - - -

A llnicom <:ompam

U.S. NUCLEAR REGULATORY CO . & 0 RULEMAKI GS & AOJUDICATIO STAFF OFFIC O THE SECRETA~

OF THE COMMISSIO Document Sta *

• October 1, 1998 U.S. Nuclear Regulatory Commission Page 2 having two regulatory-related documents on respiratory protection rather than three such documents.

Some specific comments on the proposed rule are provided below.

20.1703

( c) (5) Per the proposed rule, non-face sealing respirators do require a medical evaluation before the first field use, except as noted for single-use disposable respirators in Note e. to Appendix A. However, this exemption is inconsistent with Occupational and Safety Health Administration (OSHA) 29 CFR 1910.134(e), which requires a medical evaluation prior to use for all respirators. Since the use of this type of respirator would not normally be used for protection against airborne radioactive material, NRC regulations should not provide an exemption for these medical evaluation requirements.

( c) (6) The proposed Fit Factor of 2: 100 for any positive pressure, continuous flow, and pressure demand devices is different than OSHA 29 CFR 1910.134. Since quantitative fit tests are performed in the negative pressure mode, the fit factor of a full facepiece cartridge respirator could be the same as the half-mask cartridge respirator, i.e., I 00. OSHA 29 CFR 1910.134 requires a minimum fit factor of 500 for full facepiece respirators. It is recommended that OSHA regulations and NRC regulations be the same regarding this issue.

Appendix A to Part 20 Note c. There is an apparent typographical error in the note. The second use of the "less than or equal" sign should actually be a "greater than" sign.

Note e. The medical evaluation exemption may be inappropriate due to the fact that a medical exemption is inconsistent with OSHA 29 CFR 1910.134(e) as was discussed in the comments to the proposed 10 CFR 20.1703(c)(5) above.

October 1, 1998 U.S. Nuclear Regulatory Commission Page 3 Some models of single-use respirators are equipped with seal enhancing material, and, therefore, in those cases, there should be no difficulty in achieving a facial seal. This is in conflict with the blanket statement in the note that it is difficult to perform an effective fit check on these devices.

Respectfully, R.M.

Vice President - Regulatory Services

Innsbrook Technical Center 5000 Dominion Boulevard Glen Allen, Vir8inia 23060 DOCKETED USNRC DOCKET NUMBER o

PROPOSED RULE "98 OCT -5 All :35 g511)

VIRGINIA POWER September 30, 1998 Secretary Serial No. GL98-021 U.S. Nuclear Regulatory Commission Washington, D.C. 20055-0001 Attention: Ru lemakings and Adjudications Staff Gentlemen:

10 CFR PART 20; RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES, 63 FEDERAL REGISTER, NO. 137, JULY 17, 1998 Virginia Power has reviewed the subject entry in the Federal Reg ister and offers the comments in the attached table.

Thank you for your consideration of our comments. If you need further information, please contact Gwen Newman at (804) 273-4255, Gwen_Newman@vapower.com or Tom Szymanski at (804) 273-3065, Tom_Szymanski@vapower.com.

Respectfully, fo/Z :

es H. McCarthy, Manager Nuclear Licensing & Operations Support Attachment OCT - 7 1998 Acknowledged by card ....... w,nenMHteeet-MftMN

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAFF OFACE OF THE SECRETARY OF THE COMMISSION Docllnent Statistics Postmark Date _ J--#,~ _ _

Copies A80EIIV8d _ ____._ _

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VIRGINIA POWER COMMENTS 10 CFR PART 20; RESPIRATORY PROTECTION ANO CONTROLS TO RESTRICT INTERNAL EXPOSURES SEPTEMBER 30, 1998 Reference Comment 20.1703( c) (6) The benefit of three year fit testing may not be realized since annual (or more frequent) testing would be done for industrial respiratory protection and current common practice is to use one fit test for both programs. This would mean two separate fit test programs or remaining with the one-year frequency.

20.1703(e) The requirement to make provision for "adequate communication" may be open to various opinions of what is adequate. Depending on the definition of adequate, it may be hard to meet this requirement due to the limited communication options available with respiratory devices.

20.1703(f) The requirement for direct communication between the standby person and worker may force the standby person to remain in a high dose rate area since respiratory devices make communications difficult and wire/wireless means of communication may not be practicable. The radiological conditions requiring the worker to wear these levels of protective equipment may preclude the standby person from being in direct communication and immediately available without being so dressed themselves. This type of situation may be inconsistent with the concept of keeping total TEDE ALARA.

20.1703(h) The wording of the regulation does not convey the intent discussed on page 38514 in the Summary of Proposed Changes. The supporting discussion is quite specific concerning the intention of the NRC relative to the preventing of the presence of anything that may interfere with the respirator seal (i.e. facial hair, cosmetics, spectacle earpieces, surgeons caps, etc.). We feel that since fit testing proves the ability to properly maintain a seal, employees should not categorically be required to wash their face and hands prior to using a tight-fitting respirator.

Appendix A "Air purifying respirators with APFs ~ 100 must be equipped with particulate Footnote c. filters that are at least 99 percent efficient. Air purifying respirators with APFs

~ 100 must be equipped with particulate filters that are at least 99.97 percent efficient." The inequalities used above appear to conflict.

Appendix A "gasses" should be "gases" Footnoted.

Appendix A The word "part" should be capitalized.

Footnote f.

Inconsistent It would be beneficial for the NRC and OSHA to establish commonality between Standards the proposed revision to 10 CFR 20 and 29 CFR 1910. We will be unable to take advantage of provisions such as the relaxed fit test frequency because we also provide the fit tests for industrial respirator usage (29 CFR 1910) for which the frequency has not been relaxed.

Page 1 of 2

VIRGINIA POWER COMMENTS 10 CFR PART 20; RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES SEPTEMBER 30, 1998 Reference Comment NRC specific Public Law 104-113 states "all Federal agencies and departments shall use request on technical standards that are developed or adopted by voluntary consensus technical standards bodies, using such technical standards as a means to carry out aspects of the policy objectives or activities determined by the agencies and departments."

proposed rule An exception is allowed if compliance would be "inconsistent with applicable law or otherwise impractical". Virginia Power supports this position, therefore we would support a performance-based rule with an associated Regulatory Guide (8.15) endorsing an ANSI standard (Z88.2).

NRC specific The proposed revision to NUREG-0041 will include a lot of needed detail, such request on as how heat, discomfort, and reduced vision affect efficiency and additional NUREG-0041 guidance regarding the application and limitation of APFs. If all of this pertinent data were included in ANSI Z88.2, then there would be no need to continue maintaining NUREG-0041.

Page 2 of 2

IIALLINCKRODT DOCKETED Mallinckrodt Inc.

675 McDonnell Boulevard Improving Healthcare and Chemistry U.. H:-c ti> PO Box 5840

/J I L{:o/

St. Louis MO 63134 September 30, 1998

'98 OCT -x P~

Phone: 314.895.2000 fF DOCKET Secretary PROPOSED ~o U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 "/?38511 Attn: Rulemakings and Adjudications Staff Re: Mallinckrodt Inc.'s Comments on NRC's Proposed Rule for "Respiratory Protection and Controls to Restrict Internal Exposures" Gentlemen:

Attached please find Mallinckrodt Inc.' s comments on NRC 's proposed rule for the "Respiratory Protection and Controls to Restrict Internal Exposures." This proposed rulemaking was issued in the Federal Register, Volume 63, number 137, pages 38511-38521, dated July 17, 1998.

Mallinckrodt Inc. operates under several NRC licenses at various sites.

With respect to NRC's request for specific comments on the "alternate approaches" for the proposed rule, Mallinckrodt Inc. strongly recommends that a simple "performance-based" rule be implemented to minimize the regulatory burden upon licensees. NRC does not need to establish a new set ofregulations. Instead, the NRC should endorse the ANSI standard, and NRC may wish to issue an Information Notice (IN) for any additional clarification. The performance-based approach would be compatible with the NRC's strategic assessment and re-baselining initiative of performance-based, risk-informed strategy.

Other comments from Mallinckrodt Inc. are provided in the attachment.

Mallinckrodt Inc. appreciates the opportunity for commenting on this proposed rulemaking.

If you have any questions, or need any clarification, please contact me at 314.654.7960.

Ashok K. Dhar Manager, Radiological Affairs Regulatory Compliance Department Attachment OC 1998 Acknowledged card ...........- - - - -

MALLINCKRODT INC.

Comments on Proposed Rulemaking on "Respiratory Protection and Controls to Restrict Internal Exposure"

1. A simple performance based rule should be implemented to minimize the regulatory burden upon licensees. Having only one reference to establish a program would greatly simplify the NRC's replication. Endorsing ANSI standards when they are released can be followed by an IN from the NRC for any additional clarification. If the ANSI standard changes in a way that is not commensurate the NRC's philosophy, the NRC can reestablish the full amended rule.

2. If number 1 above is not adopted, please make the following recommended changes.

(a) Pages 38515 and 38516 reference the use of half-face disposable respirators without the need for medical screening and fit testing. When referring to the NRC's Third Set of Questions and Answers to new 10 CFR Part 20 dated July 23, 1992, question number 91 states that the requirements in 10CFR20. l 703(a) must be met to utilize respiratory protection whether or not credit is taken for the device. Is this a change in philosophy by the NRC? We agree with the new rule allowing flexible application of disposable respirators if no credit is taken for their use.

(b) Fit testing requirements in the suggested rule call for achieved fit factors that are ten times the APF for the specific negative-pressure air-purifying device. This new requirement should have some indication as to how this may be achieved. Can a qualitative test be used or will a quantitative test be required?

From: <Mike_Benjamin@wastemanagement.com>

DOC ETED USNi' C To: TWD2. TWP6(CAG)

Date: 9/30/98 9:44am

Subject:

Comments - Respiratory Protection "98 SEP 30 P2 :54 L

T\FF 1

Mike Benjamin@WMI 09/30/98 08:44 AM

• :}i)

Michael J. Benjamin, RRPT 403 West Main Street Williston, SC 29853 803.541.5014 (work)

September 30, 1998 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudication Staff

Subject:

Comments on "Respiratory Protection and Controls To Restrict Internal Exposure" The NRC published proposed changes to 10 CFR 20, Respiratory Protection and Controls to Restrict Internal Exposures, in the July 17 Federal Registrar (Volume 63, Number 137, page 38511 - 38521) and requests comments which are due by Sept. 30, 1998.

"The NRC staff specifically requests comment on whether the technical aspects of the rule should be addressed through alternative approaches other than the proposed rule, such as a simple performance-based rule with a Regulatory guide endorsing ANSI standards to permit a more rapid regulatory response by the NRC to future technical developments and changes in industry standards."

Comment:

The OSHA recently published, as a final rule, 29 CFR 1910.134, "Respiratory Protection" with an effective date of Oct. 5, 1998. This standard requires employers to establish and maintain a respiratory protection program that includes selection, medical evaluation, fit testing, use, maintenance and care, training, record keeping and program evaluation. NRC licensees are required to meet this OSHA standard and the NRC should recognize this standard QC1' - 998 Acknowledged by card-~~~--

as a basis for Part 20's Respiratory Protection standard. If the NRC recognized and referenced 29 CFR 1910 .134 licensee's would have one common standard for respiratory protection not two (both the OSHA standard and the NRC standard) providing some administrative relief.

The NRC proposes in Section 20.1003, Definitions, to add definitions that are provided in the OSHA Respiratory Protection standard (1910.134 (b)).

Comment:

Terms such as "Fit Check" proposed by the NRC tend to confuse and conflict with the OSHA term "User Seal Check" and should be consistent. By referencing the OSHA standard employers providing and employees using respirator protection would stay better informed with a common set of respiratory protection definitions.

In Section 20.1703 (c)( 6) the NRC proposes to change the frequency of fit tests from annual to "not to exceed 3 years" placing the requirement to perform continual physiological evaluations of employees on the licensee (employer).

Comment:

Changing the frequency of fit tests from annually to "not to exceed 3 years" appears to be an unnecessary burden on the licensee and a requirement that could be subjectively enforced.

The proposed standard does not provide clear direction for the documentation of the employee evaluations preformed to ensure that licensee has met the Commissions expectations for these evaluations.

Thank you for the opportunity to submit comments and recommendations.

Sincerely, Michael J. Benjamin, RRPT

DOCKET BER SEP 2 8 1998 PROPOSED RULE o2o

( ~3F{( '385l ij Comments on Respiratory Protection and Controls To Restrict Internal Exposures 63 FR 38511 Disclaimer: The opinions expressed below are my own, and have not been reviewed or approved by Battelle, the Pacific Northwest National Laboratory, or the U.S. Department of Energy.

Daniel J. Strom, Ph.D., CHP

)> 0 Risk Analysis and Health Protection, K3-56, o ::o--n Pacific Northwest National Laboratory c_ c='

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[Jr, *-' 0 Battelle Boulevard, P.O. Box 999,  ;;=- - V) 0 l'T1

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Introduction

\0

-n The choice of the phrase "restrict internal exposures" confounds the concepts of restricting intakes and restricting dose equivalents. Restricting intakes of radioactive materials will restrict dose equivalent, but it is only one method of doing so. Enhanced decorporation through decontamination, emesis, chelation, purgatives, and competitive mass action may also limit dose equivalent after intake.

Comments

1. The phrase"internal exposure" should be abandoned in favor of clearer terminology that communicates to non-experts and scientists outside of health physics. "Internal exposure" is an oxymoron that confuses workers, educated lay persons, physicians, toxicologists, and industrial hygienists. The NRC should avoid "internal exposure;" NRC should use "intake" or "dose from internal radioactive material" depending on context. A confusion exists between the use of "exposure" to mean the process of encountering an agent or energy field (the meaning understood by workers, educated lay persons, physicians, toxicologists, and industrial hygienists), and the use of "exposure" as a generic term for absorbed dose or dose equivalent.

There is also a confusion between the process of exposure and the process of irradiation. For radiation sources outside of the body, exposure and irradiation are simultaneous. For doses from intakes of radioactive material, exposure to the material is completely distinct from subsequent irradiation by the material in the body. By using "internal exposure," the NRC perpetuates the confusion of exposure with irradiation. See figure, tables and discussion below.

2. The NRC should avoid the phrase "internal dosimetry;" NRC should use "intake dosimetry."

3. The NRC should use "deposition" only for the process of deposition, and use "retained quantity" for an amount of activity. Tritium, 14 C, 85 Kr, 137Cs, etc. do not "deposit" in the body in the sense ofradium or strontium translocating to bone and being largely retained there (even Strom DJ. Comments on "Respiratory Protection and Controls To Restrict Internal Exposures" 63 FR 38511 p. 1 Se: 3 0 1998 o edgedbycard ..- - - - - -

though much remodeling occurs) over decades.

Discussion Following are several comments supporting the above-referenced clarifications in language.

Definitions The word expose is a transitive verb with several related meanings, two of which are confused in health physics. One meaning of expose is to submit, subject or allow to be subjected to an action or an influence; for example, to expose people to fine arts, to expose someone to a disease, to expose a worker to dust. Another distinct and specific meaning is to subject something (e.g.,

photographic film) to the action of radiant ener'gy or light.

The word exposure is a noun meaning the act, condition, or instance of being exposed A related meaning of exposure is the amount or quantity of the agent to which something is exposed, such as the amount of light reaching film. Exposure has taken on two special meanings in radiological physics. The first is the quantity of charge liberated per unit mass in air by photons between the energies of 10 keV and 3 MeV. The second is the product of potential alpha energy concentration (PAEC) and time, expressed in J*h*m- 3 or working level months (WLM).

The Phrase "Internal Exposure" Is Confusing

• All sources of radiation start EXTERNAL to body

• All irradiated organs are INTERNAL to the body

• Exposure to a non-health physicist means uncovering, being exposed to an agent (microbe, chemical, radionuclide, energy field) outside the body Strom DJ. Comments on "Respiratory Protection and Controls To Restrict Internal Exposures" 63 FR 38511 p. 2

Irradiation: Where And When "Ontakes" of Radioactive Intakes of External Material (Skin Radioactive Source Contamination) Material Irradiation Source Is Outside of Body Irradiation Source Is On Body (Topical)

Irradiation Source Is Inside of Body Exposure and Irradiation Simultaneous Sequential (?) Sequential .

Course of Irradiation Can Be Altered after Exposure Strom DJ. Comments on "Respiratory Protection and Controls To Restrict Internal Exposures" 63 FR 38511 p. 3

Source Exposure Intake or On e Irradiation and Fate of Source

1. Airborne radioactive 1. Person encounters 1. Intake by inhalation: Irradiation by Internal Source 1. Material irradiates lung tissue and body from R material (radioactive contaminated air airborne radioactive 1, 2, 3a & 3b. tract gas or aerosol) material enters

• Material emits radiation from

• Some material may be absorbed systemically from respiratory tract (R within body R tract; tract)

• Source stays with person for some

• Some material may translocate to GI tract; see 2 period of time below.

• Material irradiates "while passing

2. Food-borne 2. Person eats or 2. Intake by ingestion: through" 2. Material irradiates GI tissue and body from GI radioactive material:

Radioactive material in drinks contaminated food or beverage, or radioactive material enters the

. Some or all material eliminated tract

• Insoluble material passes through (essentially from body by decay and/or by or on food, drink, has oral contact with gastrointestinal tract natural or enhanced decorporation remains "outside" of the body, in the contents of cigarette, gum, other contaminated (GI tract) the GI tract) cosmetics, etc. items

• Some material may be absorbed systemically from GI tract

3. Surface-borne 3a. Person's skin 3 a. Intake by entry 3a. Material irradiates body from wound site radioactive material: broken by through wound or

• Some material may be absorbed systemically from Radioactive material on contaminated surface injection wound site surfaces, in or object

• Some material may translocate via lymphatic environment system

• Some material may remain at wound site indefinitely 3b & 3c. Person 3b. Ontake followed 3b. Some material may be absorbed systemically from comes in contact by intake: partial or skin with contamination total absorption of or contaminated material in contact with Irradiation by Topical Source 3b & 3c. Topical material irradiates nearby tissues surface skin through intact skin 3b & 3c. preferentially due to range and inverse square law

• Material emits radiation while in effects.

contact with skin 3 c. Ontake not

• Source stays with person for some followed by intake: period of time material remains on

• Material removed by decay and/or skin, in contact sloughing

4. Radiation- 4. Person comes 4. No intake or ontake Irradiation by External Source 4. Machine or material emits radiation which generating device or near a source of of source itself 4. Machine or material remains penetrates body, irradiating tissues radioactive material penetrating radiation outside of body that remains outside of the body Strom DJ. Comments on "Respiratory Protection and Controls To Restrict Internal Exposures 63 FR 3 8511" p.4

' SOURCE EXPOSURE INTAKE IRRADIATION person encounters contaminated air radioactive material in air radioactive material in some prompt elimination food, drink

• of material radioactive material on surfaces (ontake) radiation person comes near source radioactive no intake of material material in container or radiation emitted from x-ray machine outside of body The figure illustrates the distinction between "exposure" to radioactive material and the subsequent, perhaps protracted, "exposure" to radiation emitted by that material while some of it is retained in and/or on the body.

Communication clarity is enhanced if the latter "exposure" is called "irradiation."

Sources, Exposures, Intakes and Ontakes, and Irradiation, Dan Strom, July 1996 p.5

Conclusions

• "Internal exposure" is an oxymoron that confuses workers, educated lay persons, physicians, toxicologists, and industrial hygienists.

• Communication is enhanced if we distinguish between exposure and irradiation:

- Being near radioactive materials or radiation generating machines that emit penetrating radiation may result in irradiation by an external source. Exposure to the source and irradiation by the source are simultaneous. There is no intake of material. Irradiation ceases when exposure ceases.

- Exposure to air-, food-, drink-, and surface-borne radioactive materials may result in intake or ontake of material, with subsequent irradiation by a topical source or irradiation by an internal source or both. Exposure to the material and irradiation by the material occur at different places and different times. Following o~take or intake, material may remain on or in a person for an extended period of time. Irradiation usually continues after exposure ceases, and irradiation patterns change over time.

Strom DJ. Comments on "Respiratory Protection and Controls To Restrict Internal Exposures" 63 FR 38511 p. 6

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service OOCKETfD USNRC National Institute for Occupational Safety and Health Robert A. Taft Laboratories "98 SEP 29 P2 :45 4676 Columbia Parkway Cincinnati OH 45226-1998 OFFir.1*: * * ~. T' ~h\, September 28, 1998 RUI_J_i'

• I JU AOJUD!C ~  : TAFF Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff

Dear Sir/Madam:

Staff of the National Institute for Occupational Safety and Health (NIOSH) have reviewed the proposed rule on Respiratory Protection and Controls to Restrict Internal Exposures, published in the Federal Register on July 17, 1998 [63 FR 38511]. Our comments and references are enclosed.

If you have any questions regarding our comments, please call me at 513/533-8302.

Sincerely yours, Paul A. Schulte, Ph.D.

Director Education and Information Division Enclosure SEP 3 O 1998 Ackrtowtedged by card H*HNIHfHfttrH IOOHc Ill I O-

lJ .~uv1u:ttn REGULAT ISS fi S& ADJU0 AFF OFFICE OF THE SECRETAR OF THE COMMISSI

} -

,l..y#'-~~.t;:1:;_.-:r... C~ )-...u...,..!D 5

comments to NRC Comments of the National Institute for Occupational Safety and Health on the Nuclear Regulatory Commission Proposed Rule on Respiratory Protection and Controls to Restrict Internal Exposures

[10 CFR Part 20]

U.S. Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 9/28/98 L

The National Institute for Occupational Safety and Health (NIOSH) has the following comments on the Nuclear Regulatory Commission (NRC) proposed rule, Respiratory Protection and Controls to Restrict Internal Exposure (10 CFR 20), published in the Federal Register on July 17, 1998 [63 FR 38511]. These comments are intended to help improve the quality of the proposed rule.

20.1003 Definitions. The proposed definition for fit check includes irritant smoke check as an example of an acceptable fit check. NIOSH recommends against the use of irritant smoke as the challenge agent for respirator fit testing or fit checking because of the health risk associated with exposure to irritant fume (hydrogen chloride) [NIOSH 1995]. A negative pressure check, positive pressure check, or isoamyl acetate are acceptable substitutes for irritant smoke.

20.1703 Use of individual respiratory protection equipment. (a). This proposed paragraph requires licensees to use "only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health." This proposed wording removes the language "or had certification extended by NIOSH" from the existing 20.1703(a)(1 ). NIOSH agrees with the proposed change to this paragraph; the approval labels for NIOSH-certified respirators do not reflect extensions of certification. Therefore, it is difficult for a user to distinguish whether a respirator was manufactured under an original certification or an extension. However, the rationale for this change presented in the Preamble on page 38513 is inaccurate and misleading.

The Preamble states, "The words 'or had certification extended' would be deleted .

because all these extensions have expired and no new extensions will be granted."

The expiration of extensions referred to by NRC applies only to the particulate filter respirators previously certified by NIOSH and MSHA under the respirator certification regulations of 30 CFR part 11. The certification requirements for only this limited class of respirators were updated with the promulgation of 42 CFR part 84 on June 8, 1995.

The requirements for certification of all other classes of NIOSH-certified respirators are unchanged. NIOSH continues to issue new certifications and extensions of certifications for all classes of respirators certified under 42 CFR 84.

The respirator certification regulations at 42 CFR part 84 replaced those previously at 30 CFR part 11. With the July 10, 1995 effective date of 42 CFR part 84, NIOSH no longer issued new certifications or extensions of certification to particulate respirators certified under 30 CFR part 11. As a transition to the new respirators, manufacturers were allowed to sell and ship particulate respirators as approved under 30 CFR part 11 until July 10, 1998. While the manufacturers' authority to produce additional particulate respirators under the 30 CFR part 11 certifications has expired, the certifications have not been withdrawn. Any particulate respirator manufactured and maintained in accordance with 30 CFR part 11 remains a NIOSH-certified device. Particulate respirators certified under 42 CFR part 84 have demonstrated improved performance over their 30 CFR part 11 predecessors and should be available to users.

1

NIOSH suggests that the preamble explanation for the removal of the wording referring to the NIOSH extensions of certification be expanded to provide a clearer discussion of the replacement of 30 CFR part 11 respirator certification provisions with 42 CFR part 84.

20.1703(b) The identical wording removed from paragraph (a) is proposed to be removed from this paragraph, and the basis for this change provided in the Preamble is the same. NIOSH suggests that the Preamble be modified to correctly explain the change in respirator certification regulations as noted above.

20.1703(c)(3) This proposed paragraph requires an operability check (fit check or functional test) immediately prior to use only if there is an APF associated with the respirator. Single-use disposable and air-line suits are listed in Appendix A as respirator classes without an associated APF. Thus the requirement to perform operability checks immediately prior to use of these classes of respirators would not apply. Footnotes (e) for the single-use and (g) for the suit state that fit testing requirements of§ 20.1703 also do not apply.

NIOSH recommends that all tight-fitting respirators, including the single-use disposables class, should be fit tested and, as appropriate, fit checked. NIOSH also recommends that a user should verify that an air-line suit will perform properly before putting it on. The risk of carbon dioxide build-up with low airflow may be increased by the potentially large dead air space in the suit. Verification of the integrity of the suit is also recommended. If operability checks are intended for these respiratory protection devices, the preamble and regulatory language should clarify the intent. If operability checks are not required, NRC should modify the preamble to provide further information as to why disposables and air line suits would be exempted from an operational check prior to being worn.

20.1703(c)(6) This provision would require fit testing for tight-fitting, face-sealing respirators prior to first field use. NIOSH agrees that fit testing should be performed with these respirators prior to first field use. As written, all fit-tested respirators that are not negative pressure devices would only have to achieve a fit factor of ::-: 100, while negative pressure devices would be fitted to 10 times the APF. The fit factor of 100 is the same as the APF proposed for a full facepiece negative pressure respirator, while the APF of respirators other than negative pressure devices would be 50, 1000, or even 10,000. A fit factor of 1,000 (10 times the APF) would be required for a full facepiece used on a negative pressure respirator, but only 100 would be required if the same facepiece were used on the devices assigned higher protective values.

A fit factor of 100 for the devices other than negative pressure air-purifying respirators is consistent with ANSI Z88.2-1992. However, proposed 20.1703(c)(6) does not require the fit factor to be achieved in the non-operational mode, as specified in ANSI Z88.2-2

1992 and OSHA's 29.1910.134. NIOSH recommends that fit factors be achieved with the respirator in the non-operational mode to assure adequate fitting requirements for a facepiece type, regardless of the respirator operational mode in which it is used, consistent with ANSI Z88.2-1992 [ANSI Z88.2-1992, clause 9.1.2].

Because of the uncertainties involved in correlating the fit factors achieved in fit testing with protection factors reported in the workplace, NIOSH concurs with the minimum fit factor of ten times the APF value using the facepiece in order to successfully complete the fit test. This is the same safety factor required by OSHA in the Respiratory Protection Standard, 29 CFR 1910.134. As noted on page 38515 of the Preamble, footnote 'a' to Appendix A retains the requirement to select and use respirators for non-radiological hazards in accordance with 29 CFR 1910.134. These Department of Labor regulations require the same minimum fit factor for a tight-fitting facepiece, regardless of the respirator's operational mode. As proposed, a user could be required to have different size facepieces for a respirator to be used for non-radiological hazards and for radiological hazards due tor fit testing to different fit factor requirements. NIOSH recommends that NRC modify the proposal to require the same fit factor for the facepiece regardless of the respirator's operational mode to eliminate potential user confusion. Thus, according to the APF values proposed, any respirator using a half mask would be fit tested in a negative pressure mode to assure a fit factor ~ 100 (APF of 10 X 10=100), while any respirator using a full facepiece would be fit tested in a negative pressure mode to assure a fit factor ~ 1000 (APF of 10 X 100=1000).

20.1703(c) On page 39514, the Preamble incorrectly states, "Current 20.1703(c) would be removed because it requires licensees to use as emergency devices only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by NIOSH. This approval category no longer exists." Under 42 CFR 84.51, NIOSH continues to certify respirators for this category as previously required under 30 CFR 11.

20.1703(c)(6) The proposed requirement for fit-testing of respirators in this paragraph is "a frequency not to exceed 3 years." Whenever respirators are used to protect the health of workers, periodic fit testing is recommended by NIOSH [1987] and the American Industrial Hygiene Association [AIHA 1993]. Annual fit testing is the accepted standard of professional practice endorsed by the American National Standards Institute (ANSI) [ANSI Z88.2-1992, clause 9.1.4] and the National Fire Protection Association (NFPA) [NFPA 1404, 1989 edition, paragraph 4-2.3]. Annual fit testing is required by OSHA's recently issued respiratory protection standard (29 CFR 1910.134).

All of these authorities recognize periodic fit testing as the means to assure that a respirator is selected, fits, and is worn properly.

3

Industry data from OSHA's rulemaking record for respiratory protection [Docket No. H-049] suggest that 1% to 2% of users require a different size or model if retesting is annual, increasing to over 6.6% on a 2-year cycle. On the basis of these data and other considerations, OSHA concluded that annual fit testing represented an appropriate balance between unproductively testing too frequently versus testing so infrequently that too many workers would be at risk of harm because of poorly fitting respirators.

,we are not aware of any evidence that the judgment of a physician or other licensed health care professional (or any other individual) can be an adequate substitute for periodically retesting respirator fit. Neither do we know of any evaluation criteria that could be used by a physician or other health care professional to guide a "surveillance of workers for physiological changes. ... , including being alert to circumstances such as significant weight Joss or gain, facial changes, etc., that would suggest more frequent fit testing," as suggested on page 38513 of the Preamble.

Appendix A to Part 20 This appendix lists a positive pressure (PP) operational mode for some air purifying respirator types. We believe that this designation refers to powered air purifying respirators (PAPR) and recommend that the designation be changed accordingly. A respirator must meet the performance requirements of a pressure demand operational mode for NIOSH to consider it as a positive pressure device. NIOSH has not issued an approval for an air purifying respirator certifying that it meets this level of performance.

Footnote c. on page 38520 has a typographical error and should read, "... Air purifying respirators with APF > 100 must be equipped with particulate filters that are at least 99.97 percent efficient."

4

REFERENCES AIHA [1993]. Respiratory protection: a manual and guideline. 2nd ed. Fairfax, VA:

American Industrial Hygiene Association.

NFPA [1989]. Standard for a fire department self-contained breathing apparatus program. Washington, DC: National Fire Protection Association, Inc.

NIOSH [1987]. Respirator decision logic. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Center for Disease Control, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.87-108.

NIOSH [1995]. NIOSH comments on the Occupational Safety and Health Administration's proposed rule on respiratory protection, May 15, 1995, OSHA Docket No. H-049. NIOSH policy statements. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.

5

• l Respiratory Protection:

A Manual and Guideline

/

SECOND EDITION Edited by Craig E. Colton Lawrence R. Birkner Lisa M. Brosseau American Induetrlat Hy1lene ,*

Allsoclatlon FaJ.rfu:,VlrQlnla

r-rau.c.

Second Edition First printing 1991 Second printing 1992 Third prtnung 1993 ISBN 0*932627-45-5

!£:>1991 t' American lndusbial Hygiene Association 2700 Prosperity Ave .* Suite 250 Fairfax, VA 22031

'~~-~~~~~ ~S,4~ ¥KUM N1UtiM ~w"a 10131114 2B5 6030 PAGE 5/13 3

Program Surveillance and Evaluation Lisa M. Brosseau and Michael G. May Pcrtoctic review and evaluation of the respiratory pro- to a particular respiratory protection program. In most tection program are required by the Occupational cases, the questloris are very general, and reference to Safety and Health Admlntstratlon (OSHAJ so that ad- the appropriate sectlons of this manual should be an justments can be made for changes in operations, Integral part of the use of this evaluation fonn.

exposures, etc. Evaluations should occur at least an- Careful consideration should be given to the choice nually and should include updated industrial hygiene of reVjewer. The person(s) responsible f9r the day-to-monitortng results. If necessaiy. written operating pro- day operation of a respiratory protection program cedures should be moditled to reflect that reevaluation should not be the exclusive judge(s) of its proper func-and retratn1ng should occur. tlonlng, An outside party, preferably one lmowledge-An evaluation should include discussions with all able in respiratory protection, should be asked to appropriate parties, including management, program evaluate the program pertodically as well.

administrators, supervisors, and the actual respirator Points h;tve been assigned to each answer. The guide*

users. A relatiVely simple audit fonn, the Evaluation lines found at the end of the evaluation form were Form RP.6 nocated at the end of this chapter), has been included as a suggestion for use of the point system developed by the authors to be used as a guide when and should also be adapted to each particular re-the evaluator revtews the various elements of a com- Viewer's needs.

pany's respiratory protection program. For additional information on developing and us-This evaluation fonn has been developed for two ing audits, a text developed by Arthur D. Uttle is purposes: recommended. (II

1. To serve as a checklist for the development of a respiratory protection program

2. To serve as an evaluation device to detennine how well a respiratory protection program is References functioning 1. Arthur D. Uttlo, Inc,: EnvtrorunentalAud!tinQ, Fundamen-tals and Techniques, 2d ed., byJ.L. Greene, G.S. Hedstrom.

This fonn ts by no means exhaustive and ts presented and M. DIBcrto. Cambridge, Mass.: Arthur D. Little, Inc..

as a* starting place for developing an evaluation suited 1987.

11

02-27-BB 08140 FROM1NIOSH C~AB ID,304 2B5 6030 PAGE 6/13 Resp(roJDry Protection: A Manual and Guideline Program Swvetllance and Eualuatt.on Evaluatlon Form (FonnRP.6)

I. Program Administration A. Is there a written standard operating procedure for respirator uu?

• yes 1 no 0 B. Doee the standarct operating procedure contain reference to the following:

1. Hazard recognition/measurement criteria (TLVs, sampling)? yes 1 no 0

2. Respirator selectfon criteria? yes 1 no 0 3, Use of approved equipment only (National Institute for Occupatlonal Safety and yes 1 Health, Mine Safety and Health Administration, other ,tandarda)? no 0

4. Training requirements and regulerfly of repetition? . yes 1 no 0

5. Flt testing requirements (both qualitative and quantitative) and ragufarlty yes ,

of repeUtlon? no 0

6. A stated policy on faclal hair and other fitting problems? yes 1 no 'O

7. Procedures for Issuing respirators to users? yes 1 no 0

e. Procedures for Inspection and maintenance of respirators? yes no 0

9. Medical evaluation of respirator users? yes 1 no 0

10. Program evaluatton criteria? yes 1 no 0 C. Has responslblllty and authority for the respiratory protection program been assigned yes 10 to a slngle lndlvldual? no 0 D. Does the program administrator have sufficient knowledge of respiratory protection? yes 10 no 0 E. Are adequate resources allocated to ensure success (budgeted money with specific yes 10 expenses Itemized for equipment, training, etc.)? . . no 0 Total points possible: 50 Total points obtained:

-more-12

IU,r~-..e.,-wc:11 M J *'11 ltl.::::JI . . J. rl"t-Urlll'.&'-J- * --r,~ PAGE  ?/13 Program Suroelllance and EvaluatiDn Resptmtory Protection: A Manual and Guideline Fonn RP.6 Cont II. Selection Background lnfonnatlon A. Have all toxic eubatances In the plant bun llated and their Ult descrl~ (e.g., flow yes 5 charts, material safety data sheets, etc.)? no 0

e. Have all toxic substances In the plant been sampled or In some other appropriate man- yes 5 ner have their concentrations been detennlned?. no 0

c. Have the concentrations for all toxic substances been detennlned within the last year yes 5 or some other appropriate time period? (Verify this by examining records, etc,) no 0 D. Is odor threshold data, It appllcable, avallable on all toxic substances listed In (11.,A.)? yea 5 no 0 E, Have OSHA permlsslbl$ exposure llmlta (PELa) or other applicable levels been yes 5 ldenUfled for all toxic substances Hated In (11.,A.)? no 0 F. Have all lrnmedlately dangerous to life and health (IOLH) slU.1at1ona/concentratlona yes 5 bean ldenUfled? no 0 G, Have all toxic substances listed In (11.,A,) been evaluated for eye Irritation potential? yes 5 no 0 H. Have all possibly exposed employees been Identified by Job category, Including yes 5 lnfonnaUon on Job task, duration and frequency, location, and physical demands? no 0

1. Have all Job environments been measured for temperature, relaUve humidity, and yes 5 pressure conditions? no 0 J, Have all Joba been Identified In terms of work load (e.g., AOGIH or other criteria)? yes 5 no 0 K. Have all confined space situations been Identified? yes 5 no 0 Total points possible: 55 Total points obtained:

-more-13

08141 FROM,NIOSH CQAB ID,304 2B5 6030 PAGE B/13 1404-1 Copyright © 1989 NFPA, All Rights Reserved NFPA 1404 Standard for a Fire Department Self*Cont_aincd Breathing Apparatus Program

!989 Edition This edition of NFPA 1404, StandJJrd for a Fire Dtpartmmt Self-Conlaintd '3rtathing Ap-paratus Program, was prepared by the Technical Committee on Fire Service Training and acted on by the Na!ional Fi~e Protection Assod~tion, Inc. at its Annual Mectin, held May 15-18, 1989 m Washington, DC. It was issued by the Standards Council on July 14, 1989, with an effective date of August 7, 1989.

The 1989 edition of this document has been approved by the American NationaJ Standards Institute. * *

• Origin and Development of NFPA 1404 This is a new standard, developed in response to a perceived need. The Committee on Fire Service Training saw that there were no standards on a fire department pro-gram for self-contained breathing apparatus, and that the lack of guidance on subje~t areas like training, maintenance, and SCBA program evaluation could cause serious problems for the fire service. It is the hope of the Technical Committee that the void has been filled in a practic_al and reasonable manner.

~~*-" 7

, ,, \7 ~ 08 1 '42 FROM I NI OSH CGIAB 10,30'4 2B5 6030 PAGE S/13 EMEROENCY SCENE IJSE/SCBA TJV.INJNG 1404-7 Chapter 3 Emergency Scene Use 4* 1.3

• Minimum performance standards shall be established by the authority having jurisdiction for don*

ning respiratory protection equipment.

3-1 Criteria £or Use.

3-1. 1 The authority having jurisdiction shall require 4-2 Annual Personnel Certification.

respiratory protection to be used by all personnel who may 4-2;1 Prior to initial training, personnel shall be ex*

be exposed to respiratory hazards in the performance of amined and certified by a physician as being medically and their duties. physically lit in accordance with Chapter 2 of NFPA J 001, Stando.rd for Fir, Fighter Projmional Qw,lifieatiqns.

'.J*UZ* Respiratory protection shall be used by all per*

sonnel who arc exposed to respiratory hazards or who may 4*2,t.t

• If the physician. certifying personnel for be exposed to such hazards without warning. Petsonnel respiratory protection equipment use is other than the fire who arc operating in areas that may be subjec~ to the department physician, the examination report shall be sub-hazards with sufficient warning to don respiratory protec* ject to the approval of the fire department physician.

tion equipment, shall have respiratory protection. equip*

ment reaclily available for use. 4-2.2 All personnel who may be required to use respiratory protection equipment shall be medically cer*

3-l.3' Respiratory protection equipment shall be used tified by a physician on an annual basis in accorda_nce with by all personnel operating in confined spaces, below ground 5-3.6 of NFPA 1500 1 Fire Departmmt O"upati'onal Saftty a11d level, or where the possibility of a contaminated or oxygen Health Prol'am.

deficient atmosphere exists until or unless it can be established by monitoring and continuous sampling that -'*2,3* The facepiece seal capability of each member the atmosphere is not contaminated or oxygen deficient. qualified to use SCBA shall be verified by qualitative fit testing on an annual basis and any time that new types 3-1.4 When used, respiratory protection equipment shall of SCBA are issued. Each new member shall be tested be properly worn according to the manufacturer's before being permitted to use SCBA in a hazardous at-requirements, mosphere. Orily members with a properly fitting facepiece shall be permitted by the fite department *to function in 3-t.s* Personnel shall be monitored for indications of a haiardous atmosphere with self-contained breathing fatigue or other factors that can result in unsafe conditions. apparatus.

3-1,6 Members using SCBA shall operate in teams of two

• 4*2,4 Beards or faciaJ hair that interfere with the or more who arc in communication with each other through facepiece seal shall be prohibited for personnel required visual, audible, physical, safety guide rope, electronic, or to use respiratory protection equipment. If eyeglasses are other means to coordinate their activities and arc in close worn, the person shall use frames that do not pass through proximity to each other to provide assistance in case of an the seal area of the facepiecc.

emergency.

4-2.5* Personnel required to wear respiratory protection 3-1.7* When members are involved in operations that equipment in conjunction with specialized protective equip*

require the uie of SCBA or other respiratory protective ment, for example, proximity suits or totally encapsulated equipment, at least one member shall be assigned to re* suits, shall be evaluated for physical and emotional stresses main outside the area where respiratory protection is re* associated with these specialized applications.

quired. This member shall be responsible for maintaining a constant awareness of the number and identity of per* 4-2.6 The authority having jurisdiction shall be respon*

sonnel using SCBA, their location i,.nd function, and time sible for establishing a program that provides personnel of entry. Members with SCBA shall be available for rescue. training in the proper and safe use and limitations of respiratory protection equipment and related equipment, on the policies and procedures related to the authority hav-ing junsdictions's respiratory protection program, and in those areas outlined by this standard. .

The program shall also provide a means of evaluating fire tigliter performance iri the use of respiratory protec*

Chapter 4 SCBA Training tion equipment,* and their knowledge of the respiratory equipment used. Respiratory protection training shall be conducted as an ongoing training program.

4-1 Recruit Training Program. .

4.1.1

• All training related to the use, maintenance, and 4-2.1 All members who arc permitted to use SCBA shall care of respiratory protecti<>n equipment shall-be provided at least annually successfully demonstrate their ability to py instructors meeting the objectives of Level I of NFPA !flee~ t~e J?Crformance :standards set by the authority hav-1041 1 Standard for l'ire Seruict Instructor Profmional ing JUnsdictaon.

QU1Jlijications.

,t.2,8 All fire fighters shall meet t~training and penor~

4-1.2* Records shall be maintained or all respiratory pro* mancc requirements of this 11tandard prior to actual emer*,

tection training including training or personnel involved gency operations during whic~ they may be expected to in maintenance of such equipment. wear respiratory protection equipment.

• 1*EdHIO<'I

NIOSH Comments to DOL COMMENTS OF THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH ON THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION PROPOSED RULE ON RESPIRATORY PROTECTION 29 CFR Parts 1910, 1915, and 1926 Docket No. H-049 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 5/15/95

The National Institute for Occupational Safety and Health (NIOSH) supports the proposed modifications to the Occupational Safety and Health Administration *

(OSHA) standard on the use of respiratory protection (29 CFR 1910.134, 1915 .152, and 1926 .103) published in the Federal Register on November 15, 1994 ' -...,.,.--*

[59 FR 59884]. We offer the following comments for consideration.

SCOPE AND APPLICATION (Section a)

When respirators are required to protect the health of workers, paragraph (a) (2) of the proposed OSHA standard adequately describes employer responsibilities. There are several voluntary respirator use situations where an employer would not have to comply with all aspects of the OSHA respirator use standard, including when employees voluntarily use their own respirators or when employees voluntarily use employers'* respirators to further reduce exposures. Although a respiratory protection program that is established and maintained by the employer is advisable for all respirator use situations, this should not be a mandatory OSHA requirement for voluntary respirator use.

Because the risk to workers involving the improper use of negative-pressure, air-purifying respirators is thought to be low, situations for which an employer does ~ot voluntarily establish and maintain a respiratory protection program should be restricted to these devices. OSHA should consider adding a paragraph (a) (3) on the voluntary use of respirators, such as:

(3) When respirators are used in the absence of a regulatory requirement or when employees are not at risk, a respiratory protection program established and maintained by the employer is advisable but is not required. Respirators used without a respiratory protection program shall be restricted to NIOSH-approved, negative-pressure, air-purifying respirators.

DEFINITIONS (Section b)

• The following definition of fit check should be added to the final OSHA respiratory protection standard:

Fit check is a brief test done by a respirator wearer after donning a respirator to evaluate the seal between the respirator's facepiece and its wearer's face.

• Quantitative fit testing systems are available that do not involve the generation of challenge agents in chambers. Therefore, reference to the use of a challenge agent in a test chamber for determining a fit factor should be deleted from the definitions of fit factor and quantitative fit test (QNFT) in the proposed rule. The following definitions are suggested:

Fit factor is a quantitative estimate of the extent to which a respirator prevents leakage through the seal between the respirator facepiece and the wearer's face.

Fit factors range from 1 (representing no protection) to several thousand.

Quantitative fit test (QNFT) is an objective assessment of the extent to which a respirator prevents leakage through the seal between the respirator facepiece and the wearer's face.

1

• Later in these comments (see section on Fit Testing and Appendix A), the health risk associated with exposure to irritant fume is presented. The definition of qualitative fit test in the proposed respiratory protection standard should be changed to emphasize that a test agent used during a qualitative fit test be safe for exposure by both the test subject and the test administrator. The definition should also reflect the subjective nature of the test. The following definition is suggested:

Qualitative fit test (QLFT} is a subjective assessment of the fit of the facepiece of a respirator to its wearer's face using a nonhazardous test agent which is detected either voluntarily or involuntarily by the respirator wearer upon exposure to the test agent.

On page 58932, OSHA requested comments on whether the definition of service life in the proposed., rule should be replaced with the definition in the NIOSH RDL. For the purposes of the OSHA respiratory protection standard, using the more concise definition from the American National Standard for Respiratory Protection (ANSI Z88.2-1992) is recommended. The ANSI definition of service life is the period of time that a respirator provides adequate protection to the wearer.

ASSIGNED PROTECTION FACTORS (Section d)

OSHA has proposed to adopt the assigned protection factors (APFs) from the NIOSH Respirator Decision Logic [NIOSH 1987]. In determining the APF values, NIOSH began with laboratory measurements of respirator performance conducted by the Los Alamos National Laboratories in the early 1970s. These measurements were mostly based on quantitative fit-testing that was conducted in fit-test chambers. Because studies indicated that laboratory measurements of performance did not correlate well with workplace measurements of performance, NIOSH also considered published government reports and studies that were published in the peer-reviewed journals to modify the original laboratory-based APFs. Several peer-reviewed articles were rejected in this process because the protocol for performing the study did not include fit testing or did not ensure that the respirators were properly worn and functioning .

• The NIOSH definition for an APF was the minimum anticipated protection provided by a properly functioning respirator or class of respirators to a given percentage (95%) of properly fitted or trained users. When workplace data existed from studies that met our minimum criteria, NIOSH used the point estimate equation (p=0.95) to determine the APF for a given class of respirators. While workplace data were considered for several classes of respirators, only the APFs for powered air-purifying respirators (PAPRs) and continuous flow supplied-air respirators were changed. The APFs for continuous flow supplied-air respirators were based on analogy with the PAPR field studies because the minimum air flow requirements are the same for these respirators in*30 CFR 11. Data on other classes of respirators basically confirmed the APFs from the laboratory studies. Because of concerns about fit, disposable respirators were given an APF of 10 only if they have been properly fitted using a quantitative fit test; otherwise, the APF would be 5.

NIOSH will soon publish (42 CFR 84) modifications to the current respirator certification standard (30 CFR 11). This first change in a planned series of updates will establish improved filter efficiency tests and a new performance-based classification scheme for particulate filters. NIOSH will also be publishing a respirator user's guide that will provide APFs and other information that will be needed for the new classes of respirators (59 Fed.

2

Reg. 1 26850 (1994)]. NIOSH APFs in the Respirator Decision Logic will continue to apply to respirators certified under 30 CFR 11.

FILTER USE (30 CFR 11)/AEROSOL SIZE CRITERION (Section d)

Respirator experts have been concerned for many years about the potential for small particles to penetrate Dust and Mist (OM) and Dust, Fume, and Mist (DFM) filters certified under 30.CFR 11. Laboratory research beginning in the early 1970s and continuing into the 1990s demonstrated that some but not all members of these filter classes allow significant penetration of submicron-sized particles. Some of the more recent of these studies conducted by NIOSH or through NIOSH grants, continue to show significant penetration of submicron particles for OM and DFM filters [Hinds and Kraske 1987; Hinds and Bellin 1987; Moyer and Stevens 1989a; Moyer and Stevens 1989b; Stevens and Moyer 1989; Chen et al. 1992]. Additionally, submicron particulates present special medical concerns because they can diffuse throughout the respiraeory system.

Furthermore, published data are limited describing worksites where substantial exposures occur to submicron particles and published research is inadequate to characterize the prevalence and types of worksites and work processes where DM and DFM filters are being used for protection against submicron particulates.

The existing information on small particle penetration led the American National Standards Institute (ANSI) in 1992 to recommend that DM and DFM filters be used only in workplaces where the aerosols had been characterized and were known to have a mass median aerodynamic diameter (MMAD) 2 of 2 µm and larger. Where the aerosol is smaller or of unknown size distribution, ANSI recommended only HEPA-filter respirators be used [ANSI 1992].

For particulate-filtering respirators certified under 30 CFR 11, NIOSH recommends that OSHA adopt a particle-size/filter-selection criterion that will be as protective as the ANSI recommendation for filter selection. The aerosol size-based filter selection recommendation would apply only to filters certified under 30 CFR 11. It would not apply to the new class*es of filters that will be certified by NIOSH under 42 CFR 84 because those new filters will be certified against the most penetrating size range of submicron particles.

This will ensure that all filters certified under 42 CFR 84 are fully effective against any particle size, including small and submicron particles.

IMMEDI.ATELY DANGEROUS TO LIFE AND HEALTH (IDLH) VALUES . (Section g)

NIOSH concurs with OSHA on the definition (page 58938) of immediately dangerous to life and health (IDLH). That definition is consistent with the definition in the NIOSH Respirator Decision Logic [NIOSH 1987] and the NIOSH Pocket Guide to Chemical Hazards [NIOSH 1994a].

Oxygen Deficient Atmosphere NIOSH will be providing posthearing comments to OSHA on oxygen deficient atmospheres.

1 Federal Register. See Fed. Reg. in references.

2 50% of the particulate mass is contained in particles below the MMAD and SO% of the particulate mass is contained in particles above the MMAD.

3

Chemical Contaminant IOLH Atmospheres NIOSH has recently reviewed, and in many cases made more protective, its IDLH values for chemical contaminants [NIOSH 1994a]. NIOSH recommends that OSHA use these new IDLH values as criteria for selecting the most protective respirator.

The criteria used to develop these IDLH values include the preferential use of human toxicity data followed by acute animal toxicity data. When acute toxicity d.ata were insufficient or unavailable, then NIOSH considered chronic toxicity data or an analogy to a chemically similar substance [NIOSH 1994b).

RESPIRATOR FIT TESTING (Section f)

Because no single fit test procedure has been demonstrated to be a reliable predictor of worker exposure, NIOSH recommends that OSHA recognize any of the following fit test procedures as acceptable:

• Quantitative fit tests using a non-hazardous challenge aerosol (such as corn oil or sodium chloride),.generated in a test chamber, and employing instrumentation to quantify the.fit of the respirator.

• Quantitative fit test using ambient aerosol as the challenge agent and appropriate instrumentation to quantify the respirator fit*.

• Quantitative fit tests using controlled negative pressure and appropriate instrumentation to measure the vo.lumetric leak rate of a facepiece to quantify the respirator fit.

• Qualitative fit tests using a non-hazardous test agent that is readily detected by the test subject. Qualitative fit tests using saccharin as the test agent are not recommended because it is a potential carcinogen and chere is an acceptable alternative test agent (e.g., bitrex)

[Niemeier 1991; Wilmes 1994). Qualitative fit tests using irritant fume as the challenge agent are not recommended because of the health risk associated with exposure to the irritant fume (see discussion in Appendix A) .

rn the future, as additional test methods are developed, OSHA should publish them and receive public comment on whether to accept their use.

NIOSH does not. agree with the proposal to establish one test method as the standard against which other fit tests are to be judged. The fit test proposed by OSHA (OSHA Appendix A) as the reference standard has not itself.

been validated. That i*s, the OSHA proposed fit-test has not been demonstrated to correlate with the fit of the respirator when worn in actual workplace situations. In fact, there are data suggesting that the reference fit test proposed by OSHA does not correlate with the fit achieved in the workplace under actual conditions of use [Dixon and Nelson 1984; Myers et al. *1904; Gaboury et al. 1993]. Only the controlled negative pressure fit test system, which has been excluded in the OSHA proposal, has been subjected to limited validation [Decker and Crutchfield 1993).

MEDICAL EVALUATION CRITERIA (Section e)

NIOSH agrees with OSHA that the fitness of an individual to wear a respirator should be determined by a physician using the detailed information of the proposed respirator use and work conditions. NIOSH also agrees that there is a considerable difference of opinion regarding the necessary elements of this 4

determination which cannot be resolved based on the peer-reviewed literature.

The stresses imposed by the different types of respirators and work, and the*

fitness of potential respirator wearers vary widely.

Given the complexity of these multiple factors, NIOSH recommends that OSHA allow the content of the medical evaluation for prospective respirator wearer's be decided by a knowledgeable physician. "Medically evaluated" could mean assessment of a questionnaire by the physician or a knowledgeable health-care professional under the supervision of the physician. The physician should also determine whether symptoms or medical conditions developing between scheduled evaluations warrant an additional, interim evaluation. This approach is closest to OSHA's first proposed alternative. As suggested in OSHA's third alternative, the use of a questionnaire to screen prospective respirator wearers would frequently be an appropriate and sufficient approach to medical evaluations. Responses to the questionnaire would identify those individuals requiring further evaluation. NIOSH recommends that the frequency of medical evaluations be not less than every five years. More frequent evaluations will be indicated in many settings, depending on the respirator use, exposure and.other work conditions, and employee characteristics.

The inclusion of a non-mandatory appendix may be useful, although NIOSH questions whether a medical examination should always include pulmonary function testing. OSHA could consider adding to its non-mandatory appendix a listing of medical tests (e.g., spirometry, resting electrocardiogram (ECG]

and exercise tests, chest x-rays (CXRs], hearing and vision tests, and blood tests) that are sometimes used in certain situations. The decision to use a particular test would be made .by the physician, based on the respirator to be used, the anticipated work activities and environment, and the worker's age and health status. ,For physicians seeking additional information and advice to apply to their specific situation, there are a number of published reviews of the effects of respirator wear, and recommended medical evaluation guidelines, which NIOSH would be willing to identify for OSHA.

NIOSH recommends that all individuals required to use respirators be medically evaluated, regardless of the expected duration of respirator use. The potential adverse effects of respiratory use are primarily dependent on the type of respirator, the details of the;work and environment, and.the individual, rather than the time of respirator use. The responsible physician should be allowed to tailor the evaluation to meet the needs of the specific situation.

In summary, the assessment of medical fitness to wear a respirator is too complex to be addressed by any predetermined algorithm. The physicians's judgement is the most ~ritical factor in identifying workers who should be proscribed from using respiratory protection. NIOSH supports the current J approach of allowing considerable latitude to the responsible physician and helping ensure that they are sufficiently informed of the relevant risk factors.

USE OF RESPIRATORS (Section g)

1) Re~se'of Disposable Respirators The resistance to degradation of particulate filters certified under 30 CFR 11 is not well-defined, although it is known that humidity and oil mists may degrade the performance of: some. Until particulate filters certified under 42 CFR 84 become available, NIOSH recommends that reuse of disposable particulate respirators beyond a single shift be r~stricted to HEPA filter respirators. HEPA filters have been shown to be resistant to degradation by humidity [Moyer and Stevens 1989]. Some models may be affected by high levels of other degrading contaminants, such as oil 5

mists, but only at levels expected to be highly uncommon for most worksites. NIOSH does not recommend the reuse of DM and DFM respirators, many models of which may degrade in oil mists and humid environments, in any worksite.

Resistance to degradation will be better documented for particulate filters to be certified under 42 CFR 84. NIOSH recommends that after those filters become available, only Part 84 filters should be considered for reuse beyond a single shift.

Disposable respirators should be discarded whenever they become soiled, contaminated, damaged., malodorous, difficult to breathe through, or reach their end-of-service life. To minimize cross-contamination and deformation of the sealing surface from different face shapes, a disposable respirator should be worn by only one worker. Therefore, OSHA should revise paragraph (g) (9) to allow the reuse of certain disposable respirators. The following paragraph is recommended:

"The employer shall ensure that disposable HEPA respirators certified by NIOSH under 30 CFR Part ll and used in environments that do not contain filter-degrading aerosols (e.g., oil mist) are discarded when they become soiled, contaminated, damaged, malodorous, difficult to breathe through, or when their service life has ended; reuse may extend beyond one work shift. Disposable HEPA respirators that are used in filter-degrading aerosols and all other disposable respirators shall be discarded under the same conditions, but their use shall not exceed one work shift. A disposable respirator shall be used by only one worker."

OSHA should also add a separate section to paragraph (g) that describes when replaceable filters, cartridges, and canisters should be discarded.

The following paragraph is recommended:

"The employer shall ensure that replaceable HEPA cartridges certified by NIOSH under 30 CFR Part ll used in environments that do not contain filter-degrading aerosols (e.g., oil mist) are discarded when they become contaminated, damaged, difficult. to breathe through, or when their service life has ended; reuse may extend beyond one work shift. Replaceable HEPA cartridges that are used in filter-degrading aerosols and all other replaceable filters, cartridges, and canisters shall be discarded under the same conditions, but their use shall not exceed one work shift."

2) Beards and Respirators On page 58921, OSHA requested comment on the issue of workers with .beards who are required to wear respirators. In addition to personal preference, some men wear beards for religious or medical reasons. NIOSH recommends that OSHA state in the final rule that when the respirator-use situation permits, employers are allowed to accommodate bearded workers by providing them with a respirator whose function is not affected by facial hair.

OSHA may want to cite examples of appropriate respirators that can be worn by bearded workers such as PAPRs and supplied-air respirators with hoods or other loose-fitting facepieces and inappropriate respirators such as negative-pressure respirators with tight-fitting facepieces.

3) Contact Lenses and Respirators NIOSH is not aware of any documented evidence that use of contact lenses affects the performance of a respirator. Neither is NIOSH aware of any 6

documented evidence that use of contact lenses creates special hazards for respirator users. Therefore, OSHA should allow the wearing of contact lenses during respirator use. , The National Fire Protection Association (NFPA) allows use of soft contact lenses during the use of self-contained breat~ing apparatus (SCBA), " ... provided that the member has previously demonstrated successful long-term contact lens use" [NFPA 1992]. The NFPA standard does not allow use of hard contact lenses during SCBA use.

4) Selection of Powered Air-Purifying Respirators On page 58923 of the proposed rule, OSHA requests comment on whether employees should be able to choose PAPRs rather than negative-pressure respirators because of their reduced breathing resistance. NIOSH agrees with OSHA that the respirator program administrator is responsible for respirator selection. NIOSH also agrees that OSHA should not dictate the circumstances of PAPR use involving employee requests based solely on breathing resistance and comfort~ It should be clear that the employer is permitted to provide a higher level of protection than the minimum demanded by working conditions.

7

Appendix.A DISCUSSION ON IRRITANT FUME FIT TEST The following information supports a recommendation against use of the irritant fume qualitative fit test:

The irritant fume protocol described in the proposed rule requires the use of ventilation smoke tubes to qualitatively test the fit of a respirator's facepiece to its wearer's face. The protocol recommends the use of a. MSA smoke tube (part number 5645) or equivalent. Two companies (MSA and Sensidyne, Inc.) sell ventilation smoke tubes that contain stannic chloride.

When stannic chloride hydrolyzes with ambient moisture, a characteristic smoke is produced consisting of white hydrochloric acid fume or smoke, stannic oxychloride, and tin compounds.

Hydrogen chloride is a strong irritant of the eyes, mucous membranes, and skin

[Hathaway et al. 1991]. Because ventilation smoke tubes produce hydrogen chloride, a test subject usually reacts involuntarily by coughing or sneezing whenever the smoke leaks into the respirator's facepiece. Thus, the likelihood that a test subject will give a false indication of proper fit is reduced [Birkner 1980; Pritchard 1976]. The NIOSH recommended exposure limit and the OSHA permissible exposure limit for hydrogen chloride are a ceiling limit of 5 parts per million (ppm). NIOSH has also established an immediately dangerous to life and health (IDLH) value of 50 ppm for hydrogen chloride

[NIOSH 1994a].

As part of a NIOSH HHE, NIOSH researchers measured the concentrations of hydrogen chloride emitted from Sensidyne smoke tubes in environments with low (14 percent) and moderate (53 percent) relative humidity [NIOSH 1993; Lenhart and Burroughs 1993]. Each measurement of hydrogen chloride was made as the irritant smoke was puffed from a smoke tube attached to an aspirator bulb during a simulation. Air concentrations of hydrogen chloride ranged from 100 ppm (measured at a distance of 6 inches) to 11,900 ppm (measured at a distance of 2 inches).

The irritant fume protocol in the proposed rule requires smoke production by attaching one end of a smoke tube to a low-flow air pump calibrated to deliver air at a flow rate of 200 milliliters (ml) per minute. NIOSH researchers made laboratory measurements of the concentrations of hydrogen chloride emitted from ventilation smoke tubes attached to low-flow pumps calibrated to deliver 200 ml/minute or after a single squeeze of an aspirator bulb. Hydrogen '

chloride measurements were made using methods similar to those used during the.

NIOSH HHE using a Miran lA portable ambient air monitor set at a pathlength of 20.25 meters and an analytical wavelength of 3.4 micrometers.

All measurements were made in a room with 25 percent relative humidity and a temperature of 78°F. Table I contains the results of the hydrogen chloride measurements.

8

Table I Hydrogen Chloride Concentrations Emitted from Sensidyne and MSA Smoke Tubes Using an Aspirator Bulb and Using a Pump Distance from Tip of Concentration of Hydrogen Chloride (ppm)

Smoke Tube to Tubing Inlet (Inches) Sensidyne Smoke Tube MSA Smoke Tube (Part No. 501) Part No, 5645 One squeeze of aspirator bulb 12 50 700 12 so 500-6 1000 1800 6 450 >2000 1 >2000 Pump delivering 200 ml/minute 12 1500 (<20 sec.) >2000 ( <10 sec.)

Note: During testing, the relative humidity was 25% and the temperature was 78°F.

ppm: parts per million ml: milliliters sec: seconds The results shown for the Sensidyne smoke tube are consistent with the hydrogen chl.oride concentrations reported in the NIOSH HHE [NIOSH i993; Lenhart and Burroughs 1993]. The MSA smoke tube produced higher concentrations than the sensidyne tube when attached to the aspirator bulb, and the MSA tube produced greater than 2000 ppm of hydrogen chloride in less than 10 seconds when attached to the pump. These sampling results show that irritant smoke tubes produce hydrogen chloride levels that should be considered a health risk.

The irritant fume protocol thus does not meet the minimum criteria for a valid qualitative fit test described in the new fit test protocols section of Appendix A, which specifies that challenge agents should be non-toxic.

9

REFERENCES ANSI (1992). American national standard for respiratory protection. New York, NY: American National Standards Institute, ANSI Z88.2-1992.

,Birkner LR [1980]. Respiratory protection: a manual and guideline. Akron, OH: American Industrial Hygiene Association, pp. 63-64.

Chen cc, Lehtimaki M, Willeke K [1992). Aerosol penetration through filtering facepieces and respirator cartridges. Am Ind Hyg Assoc J 53(9) :566-574.

Decker JA and Crutchfield CD [1993). Feasibility of a new method to determine respirator performance by biological monitoring of exhaled air. J Inter Soc Respirat Prat 11(1) :6-19.

Dixon sw and Nelson TJ [1984]. workplace protection factors for negative pressure half~mask facepiece respirators. Journal o~ the ISRP 2(4) :347-361.

59 Fed. Reg. 26850 [1994). National Institute for Occupational Safety and Health: respiratory protective devices; proposed rule. (To be codified at 42 CFR 84.)

Gaboury A, Burd DH, Friar RS [1993). Workplace protection factor evaluation of respiratory protective equipment in a primary aluminum smelter. Appl Occup Environ Hyg 8(1) :19-25.

Hathaway GJ, Proctor NH, Hughes JP, Fischman ML, eds. [1991]. Proctor and Hughes' chemical hazards-of; the workplace. 3rd ed. New York, NY: Van Nostrand Reinhold, pp. 332~333.

Hinds WC and Bellin P (1987]. Performance of dust respirators with facial seal leaks: ~I. Predictive model. Am Ind Hyg Assoc J 48(10) :842-847.

Hinds WC and Kraske G [1987] ~- Performance of dust respirators with facial seal leaks: I. Experimental. Am Ind Hyg Assoc J 48(10) :836-841.

• Lenhart SW and Burroughs GE (1993]. Occupational health risks associated with the use of irritant smoke for qualitative fit testing of respirators. Appl Occup Environ Hyg 8(9) :745-751.

Moyer ES and Stevens GA [1989a). "Worst case" aerosol testing parameters: II.

Efficiency dependence of commercial respirator filters on humidity pretreatment. Am Ind Hyg Assoc J 50(5) :265-270.

Moyer ES and Stevens GA [1989b]. "Worst case" aerosol testing parameters:

III. Initial penetration of charged and neutralized lead fume and silica dust aerosols through clean, unloaded respirator filters. Am Ind Hyg Assoc J 50 (5) :271-274.

Myers WR, Peach MJ, Cutright K, Iskander W [1984]. Workplace protection

.factor measurements on powered air-purifying respirators at a secondary lead

\ smelter: results and discussion. Am Ind Hyg Assoc J 45(10) :681-688.

I

~FPA (1992]. Standard on fire department occupational safety and health

,rogram. Quincy, MA: National Fire Protection Association.

\\

iemeier RW (1991]. Letter of April 19, 1991, from R.W. Niemeier, Division of tandards Development and Technology Transfer, to Donald Wilmes, 3M.

10

NIOSH [1987]. NIOSH respirator decision logic. Cincinnati, OH: U.S.

Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.87-108. *... ,**

NIOSH [1993]. Health hazard evaluation report: Anchorage Fire Department, Anchorage, AK. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, NIOSH Report NO. HETA 93-0040-2315.

NIOSH (1994a]. NIOSH pocket guide to chemical hazards. Cincinnati, OH: u.s.

Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.94-116.

NIOSH [1994b]. Documentation for immediately dangerous to life or health concentrations (IDLHs). Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.

Pritchard JA [1976]. A guide to industrial respirator protection.

Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Center for Disease Control, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.76-189.

Stevens GA and Moyer ES (1989]. "Worst case" aerosol testing parameters: I.

Sodium chloride and dioctyl phthalate aerosol filter efficiency as a function of particle size and flow rate. Am Ind Hyg Assoc J 50(5) :257-264.

Wilmes D (1994]. Letter of May 18, 1994, from Don Wilmes, 3M, to Richard W.

Niemeier, Division of Standards Development and Technology Transfer, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Public Health Service, U.S. Department of Health and Human Services.

11

Respi,i_,.,.___,,._tor Decision

,o,,e U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Se rvice Centers for Disease Control Notional Institute for Occupational Safety and Health

N I OS H R ES P I RAT OR DEC I S I ON L OG I C U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Pub I ic Health Service Centers for Disease Control National Institute for Occupational Safety and Health Division of Standards Development and Technology Transfer May 1987

DISCLAIMER

• Mention of the name of any company or product does not constitute endorsement by the National Institute for Occupational Safety and Health.

• DHHS (NIOSH) Publication No.87-108 t

ii

FOREWORD The initial Respirator Decision Logic was developed in 1975 as part of the Nati ona I Ins t.i tute for Occupa ti ona I Safety and Hea I th/Occupa ti ona I Safety and Health Administration (NIOSH/OSHA) Standards Completion Program and was updated in 1978. Due to technical advances in respirator design and research, NIOSH has again revised the Respirator Decision Logic.

This rev1s1on retains many aspects of the original Respirator Decision Logic, but it differs in five areas: odor warning properties with respect

" to air-purifying cartridge/canister respirators, recognition of the problems in assigning protection factors, changes in protection factors for certain respirator classes, respirator recommendations for carcinogens, and medical recommendations.

The recognition of wide variation among workers in their sensitivities for detection of odors has led to the recommendation that employers not rely solely on currently pub I ished data on odor thresholds to ensure that workers who wear air-purifying cartridge or canister respirators are capable of smel I ing the contaminant at the applicable exposure limit.

Recent research on in-plant respirator testing suggests that some previously assigned protection factors based on data from laboratory fit testing may not be valid_. This revised Respirator Decision Logic has incorporated assigned protection f~ctors based on data from recent in-plant research for some powered air-purifying respirators (PAPR) and some similar respirators, such as loose-fitting and tight-fitting continuous flow air-line respirators. Since NIOSH maintains that there is no safe exposure to carcinogens, only the most protective respirators should be used to protect workers from exposure to carcinogens in t_he workplace. Finally, specific medical recommendations are included to assist physicians in determining an individual's fitness to wear a respirator.

Donald Millar, M.D., D . T . P . ~

Ass1 ant Surgeon General Director, National Institute for Occupational Safety and Health Centers for Disease Control iii

ACKNOWLEDGMENTS This Respirator Decision Logic was prepared by a subcommittee of the NIOSH Respiratory Protection Committee, Sheldon H. Rabinovitz, Ph.D., Chairman.

The Committee consists of members of each Division of NIOSH. The subcommittee consisted of the fol lowing individuals:

Warren R. My~rs, Ph.D., Chairman, DSR Nancy J. Bal I inger, DSR Thomas K. Hodous, M.D., DRDS Nelson A. Leidel, Sc.D., OD Sheldon H. Rabinovitz, Ph.D., DSDTT Laurence D.* Reed, DSR The document was reviewed by the fol lowing experts in respiratory protection:

Earle Shaub, Consultant Robert A. daRoza, Chairman, ANSI 288 Committee Mark Nicas, California Division of Occupational Safety and Health Christopher C. O'Leary, Chairman, American Industrial Hygie~e Association, Respiratory Protection Committee Robert C. Spear, Ph.D., Professor and* Director, Northern California Occupational Health Center, University of California, Berkeley In addition, appreciation is extended to the following persons for their assistance in preparing this document:

R. Schutz for techriical review; C. Browning, R. Grubbs, E. Kuempel, and H. Linn for editorial review; and J. Curless, L. DeVor, B. El I is, J. Hamons , D. Hi I I , C.. KI inker , N. Morgan , and A. Ri t chey for typing .

iv

CONTENTS Page FOREWORD iii ACKNOWLEDGMENTS iv TABLES AND FIGURE vi I. INTRODUCTION 1 A. Background and Scope 1

8. Cautionary Statements 2 I I. RESPIRATOR DECISION LOGIC 5 A. Criteria for Selecting RespJrators 6 B. Restrictions and Requirements for Al I Respirator Usage 7 C. Respirator Decision Logic Sequence 8-D. Subparagraphs 21 :1

1. Oxygen-Deficient Atmosphere 21

2. Exposure Limits 21

3. Immediately Dangerous to Life or Health (IDLH) 22

4. Eye Irritation * *23

5. Escape Apparatus 24

6. Potential Warning Properties for Use with Cartridge/Canister Air-Purifying Respirators 26

7. Limitations of Respirators for Gases and Vapors 27

8. Assigned Protection Factors 27

9. Particulate Filter Respirators 29

10. Suggested Medical Evaluat_ion and Criteria for Respirator Use 30 I I I . REFERENCES 35 IV. GLOSSARY 40 V. APPENDICES \

43 A. NIOSH Policy Statement on Approval of Air-Purifying Respirators with End-of-Servjce-Life Indicators 43 B. NIOSH Policy Statement on Use of Single-Use and Dust and Mist Respirators for Protection Against Asbestos 47 C. Odor Warning: Background Information 48 D. Protection Factor: Background Information 50 E. Medical Aspects of Wearing Respirators: Background Information 52 V

TABLES Number*

1. Assigned protection factor classifications of respirators for protection against particulate exposures 13

2. Assigned protection factor classifications of respirators for protection against gas/vapor exposures 15

3. Assigned protection factor classifications of respirators for protection against combination gas/vapor and particulate exposures 17

4. Selection options for escape respirators 25

5. NIOSH recommended maximum use concentrations for gas and vapor air-purifying elements 28

6. Sugges~ed frequency of medical fitness determinations 32 FIGURE Number

1. Flow Chart of Respirator Decision Logic Sequence vi

I. INTRODUCTION A. Background and Scope The National--- Institute for Occupational Safety and Health (NIOSH) routinely makes recommendations regarding the use of r'espirators for workers exposed to workplace environments that contain hazardous concentrations of airborne contaminants and/or oxygen-deficient atmospheres. Such recommendations are made only* when engineering controls are not technically feasible, while controls are being installed or repaired, or when emergency and other temporary situati<;ms arise. Respirators are the least preferred method of worker protection from respiratory hazards because they can be unreliable if an adequate respiratory protection program is not established by the employer and because they require worker cooperation. The intent of this decision logic is to provide industrial hygienists and other professionals knowledgeable in respirator selection with a procedure for selecting suitable classes of respirators for particular concentrations of specific contaminants. In this decision logic, concerns are raised about limitations of the data used to set protection 'factors for several classes of respirators.

To ensure uniformity and adherence to proper respirator usage, NIOSH re'commendations have been based on the. Respirator Decision Logic developed jointly in 1975 by NIOSH and the Occupational Safety and Health Administration (OSHA) as part of the Standards Completion Program and updated in June 1978. That decision logic incorporated requirements contained in 30 CFR 11 and fit factor data developed by the Los Alamos Nati ona I Laboratory (LANL)'.

• NIOSH has now modified that dee is ion I og i c to reflect new developments that include increased use of respirators to control exposure to carcinogens in the workplace, irttroduction of new respiratory equipment, and reporting of field research data on workplace protection factors (WPF's). *

• This modified decision logic identifies the criteria necessary to determine the classes of respirators that wi 11 provide a known degree of respiratory protect ion for a given work environment, assuming tha*t the respirators are used correctly. The degree of protection is related in part to protection factors. Many of the assigned protection factors .(APF's) that appear in this decision logic are based on laboratory studies and should be regarded as approximate.

The selection of a specific respirator must be made by individuals knowledgeable about the limitations associated with each class of respirators and fami I iar with the actual workplace environment, including the job task(s) to be performed. The correct use of a respirator is just as*

important as the selection process if adequate worker protection is to be achieved. Without a complete respiratory protection program, workers wi 11 not receive the degree of protection anticipated from a respirator, even if it is a correct choice for the situation. Training, motivation, medical 1

evaluation, fit testing, and a respirator maintenance program are critical elements for the successful use of a respirator. As a minimum, compliance with 29 CFR 1910.134 is mandatory whenever respirators are used by workers,

~hether on a required or voluntary basis.

, B. Cautionary Statements NIOSH concerns about the use of respirators are discussed further in various parts of the document and are summarized in the fol lowing six cautionary statements:

• Assigned.Protection Factors In general, the assigned protection factors (APF's) that appear in this decision logic are not based on measurements :o.f actual field (workplace) performance. As noted in the footnotes accompanying Tables 1, 2, and 3, in only a few instances are the APF's based on any workplace performance testing; the majority of the APF's have no workplace performance basis at al I. APF's based solely on labo_ratory fit testing should be viewed and applied with particular caution, even when the laboratory testing involves a simulated work regimen. To date, no relation has been demonstrated between laboratory fit factors and measured workplace performance. As more performance testing of respirators is undertaken in the workplace by NIOSH and others, NIOSH may find it necessary to revise the APF's upward or downward. For the present, APF's should not be considered reliable , predictors of performance levels that wi 11 be achieved during actual use, since APF's are not based on a sufficient amount of workplace testing.

• Fit Testing No qu~litative or quantitative fit tests have been demonstrated .to be capable of effectively identifying inadequately fitting respirators (i.e., respirator-wearer combinations that prov.ide less protection than the APF). The presently used fit tests (e.g., ANSI-recommended, OSHA-approved) may fa i I to identify ind iv i dua I wearers with inadequate respiratory protection. Thus fit tests should be used with caution and with recognition of their possible deficiencies. As appropriate, periodic eva I uat ions of the effectiveness of each. resp i rafor during use in the workplace should be conducted to ensure that each wearer is being provided with adequate respiratory protection.

• QNFT Fit Factor Screening Levels I .

Regarding quantitative fit testing (QNFT), no studies are available to indicate what fit factor value (i.e., screening level) wi I I ensure a high probability of identifying inadequat_ely fitting respirators. That is, there are no studies demonstrating what fit factor values are adequate 2

accept/reject criteria for QNFT fit screening. When QNFT is used for fit screening, the fit factor screening level should be chosen with caution and with recognition of the uncertainty of its effectiveness. As appropriate, periodic evaluation of the effectiveness of each respirator during use in the workplace should be conducted to ensure that each wearer is being provided with adequate respiratory protection.

• Adequate Warning Properties No physiological effects in humans (e.g., odor, taste, eye irritation, respiratory irritation) have been demonstrated as being capable of consistently providing respirator wearers with timely, consistent, persistent, and reliable warning of hazardous airborne concentrations inside a respirator. Individual wearers may. be unable to detect the warning effect when necessary and may fai I to take action necessary to protect themselves (e.g., leaving the area where respirators are necessary or changing the sorbent cartridge or canister). When warning

• properties must be relied on as part of a respiratory protection program, the employer should accurately, val idly, and reliably screen each prospective wearer for the, abi I ity to detect the warning properties of the hazardous substance(s) at exposure levels that are less than the exposure I imits for the substance(s), Warning properties should be regarded with caution and with recognition of their unrel iabi I ity.

• Service Life Information For essentially all gases and vapors, no adequate service life information is avai Iable to respirator wearers or to those responsible for respiratory protection programs. When this information is not available, respirators with air-purifying sorbent elements should be used with caution and with recognition of the wide var i ab i Ii ty of service lives under differing use conditions. Employers should possess valid and reliable estimates of service lives for al I sorbent elements used in the respiratory protection program. Service Ii fe test data should be representative of al I* conditions of intended use that can be reasonably anticipated. Factors known to affect the service I ives of sorbent elements include, but are not limited to, the make and model of sorbent element, airborne concentrations of contaminant(s), and relative humidity through each sorbent element. When appropriate service life data is available, any reliance on the data should be undertaken with caution and

" with recognition of the I imitations and uncertainties of the information.

e Determination of Protection Factor Levels Required for Adequate Protection Workers are nev~r exposed to a single unvarying concentration of a contaminant. In a given work area, individual exposures may vary widely between workers, during a workshift, and between days. The range of potential exposures should be appropriately determined for al I workers and for al I circumstances that can be reasonably anticipated. The 3

highest anticipated exposure for each respir~tor wearer should be used to compute* the protecti-0n factor required for each wearer, Required protection factors should be used wi_th *caution and with recognition of their uncertainties. 1 4

11. RESPIRATOR DECISION LOGIC This decision logic contains a series of questions regarding situations which may require the use of respirators. (See Respirator Decision Logic Sequence, page 8.) In answering these questiqns, the user of this decision logic is assisted in identifying specific classes of respirators, applicable restrictions, and the appropriate respirator selection table to use. When using one of the tables to identify a suitable class of respirators, the user must keep in mind the restrictions identified in the question section of this dee is ion ' I oa i C.

This decision logic identifies the criteria necessary to determine the classes of respirators that wi 11 provide the minimum acceptable degree of protection for a chemical at a given concentration. Classes of respirators offering greater protection can usually be used in place of the minimuin acceptable class of respirators. Respirator classes are consistent with respirator cert i f i cat ion groupings as spec i f i ed in 30 CFR 11 .

The recommendations in this decision logic are based primarily on the physical, chemical, and toxicologic properties of the contaminant and*on the limitations of each class of respirators, including.ti ltration efficiency, air supply capability, and face seal characteristics and leakage. Thus this decision logic is limited to identifying classes of acceptable*respirators, rather than individual respirators.

• After various classes of respirators are identified as being suitable for a given situation, an evaluation is made of other factors of the particular work environment so that the best respirator within the recommended classe.s can be chosen. In some situations, the selection of a respirator classified as providing a highe~ lave~ of protection may be advisable.

To assist the user, this decision logic contains* ten subparagraphs fol lowing the Respi*rator Decision Logic Sequence that describe respirator' limitations, use of applicable exposure limits, warning properties, protection factors, oxygen limitations-,* and medical evaluation of suitability to wear respirators. Additional supporting information is contained in Appendices A th.rough E. To properly use t,his decision logic, the user should carefully.

read the subparagraphs.

• The assigned protection factors (APF's) used in this decision logic were based on quantitative fit factor data developed by Los Alamos National Laboratories (LANL) under contract to NIOSH and on field evaluation data gathered by NIOSH and others. Specific references and summaries of the data used to generate

• certain protection factors can be found in Subparagraph 8,

• page 28. Fit factors determined for the individual wearer of a respirator by quantitative fit testing or by any other method used to determine fit should not be substituted for the APF given for each class of respirators. However, the fit factor determined through quantitative fit testing must be greater. than the APF; -0therwise, the respirator cannot be used by the worker.

5

A. Criteria for Selecting Respirators To use this decision logic, the user must first assemble the necessary toxicologic, safety, and other relevant information for each contaminant, including the fol lowing:

• Gen~ral use conditions, including determination of contaminant(s);

• Physical, chemical, and toxicologic properties of* the contaminant(s);

• Odor threshold data;

• NIOSH recommended exposure limit (REL) or when no REL exists, OSHA permis~ible exposure I imit (PEL) .or other applicable expo~ure I imit;

• Immediately dangerous to life or health (IDLH) concentration;

• Eye irritation potential; and

• Any service life informatio~ available (for cartridges and canisters).

Obtaining complete information on al I criteria needed to use this decision logic may be difficult. When conflicting or inadequate data are found, experts should be consulted before decisions are made that could affect the proper use ot~ this* decision logic. In addition, the adequacy of the respirator selected is dependent on the validity of the exposure limit used. While the decision logic can be used with any exposure limit, NIOSH recommends that an REL be used when .one exists for a given contaminant. For

• a *more detailed discussion on the use of exposure I imi ts, especially when selecting respirators for protection against carcinogens, see Subparagraph 2, page 21.

The information obtained on general use conditions for respirators should include a description of the actual job task, including the duration and frequency , I oca t ion , phys i ca I demands , and i ndus tr i a I processes , as we I I as the comfort of the respirators. Some general use conditions may preclude the use of specific types of respirators in certain circumstances because the ind iv i dua I must be med i ca I I y and psycho I og i ca I I y su i tab I e to wear a given respirator for a given task, particularly if the respirator is a self-contained breathing apparatus (SCBA).

Information obtained on the service life of the cartridge/canister under conditions of intended ~se s~ould be evaluated regardless of the odor warning properties of the chemicals. These evaluabons should be based

• on al I gas(es) and vapor(s) ~resent at the temperature and relative humidity extremes (high and low) in the workplace. NIOSH recommends that when the employer or a representative of the employer conducts the tests, the challenge concentrations of the gases and vapors should be at least 10 times the maximum use concentration of the respirator. The service life value 6

obtained from these tests should be used to determine how long a cartridge/canister could provide protection under actual use conditions.

This information can be used to set up cartridge replacement schedules and should be used in conjunction with sensory warning properties. Workers should be trained to exit the contaminated area whenever they detect the odor of the contaminant. (See Subparagraph 6, page 26, for a discussion on service life testing for chemicals with poor warning properties.)

B. Restrictions and Requirements for All Respirator Usage The following requirements and restrictions must be considered to. ensure that the respirator selected wi 11 provide adequate protection under the conditions of intended use:

1. A complete respiratory protection program should be instituted which includes regular worker training; maintenance, inspection,*.cleaning, and evaluation of the respirator; use of the respirator in accordance with the manufacturer's instructions; fit testing; and environmental monitoring.

Whenever possible, quantitative ev~luation of the protection factor in the workplace should be performed to confirm the actual degree of protection provided by the respirator to each worker. Minimum respiratory protection requirements for a 11 cont am i nan ts can be found in the OSHA *safety and Health Standards, 29 CFR 1910.134, and in separate sections for specific contaminants (e.g., 1910.1001 for asbestos, 1910.1025 for lead, etc.).

2. Qualitative or quantitative fit tests should be provided as appropriate to ensure that the respirator fits the individual. Periodic evaluation of the effectiveness of each respirator during use in the workplace should be conducted to ensure that each wearer is being provided with adequate respiratory protection. When quantitative fit testing (QNFT) is used, the fit factor screening level should be chosen with caution and with the recognition of the uncertainty of its effectiveness since no studies have*

demonstrated what fit factor values provide adequate accept/reject criteria for quantitative fit screening.

3. Negative pressure respirators should not be used when facial scars or deformities interfere with the face se.al.

4. No respirator (including positive pressure respirators) should be used when facial hair interferes with the face seal.

5~ The respirators should be properly maintained, correctly used, and conscientiously worn' ..

6. The usage limitations of air-purifying elements, particularly gas and vapor cartridges, should not be exceeded.

7. The respirators must be approved by the Mine Safety. and Health Administration and the National Institute for Occupational Safety and Health (MSHA/NIOSH).

7

8. Workers should be instructed to leave the contaminated area immediately upon suspicion of respirator failure and then to determine the problem.

9. Workers are not exposed to a single unvarying concentration of a hazardous substance, rather ind iv i dua I exposures may vary throughout a worksh i ft and between days.* The highest anticipated concentration shou Id therefore be used to compute the required protection factor for each respirator wearer.

10. Respirator wearers should be aware of the variability in human responses to the warn1ng properties of hazardous substances. When warning properties must be relied on as part of a respiratory protection program, the employer should screen each prospective wearer for the ability to detect the warning properties of the hazardous substance(s) at e~posure concentrations that are less than the REL for each given substance. (See Subparagraph 6, page 26, and Appendix C, page 48, for additional information.)

11. The. assigned protection factors (APF's). that appear in this decision logic are .based for the most part on laboratory studies. However, a few APF's have b~en validated and revis~d as necessary after consideration of data obtained from studies of workplace protection factors (WPF's}. As more WPF testing of respirators is undertaken by NIOSH and others, the AP.F values may be further revised.* For the present, the APF's should be regarded as approximate if they are not based on WPF's.

C. Respirator Decision Logic Sequence After al I criteria have been identified and evaluated and after the requirements and restrictions of the respiratory protect i o.n program have been met, the following sequence of questions can be used to identify the class of respirators that should provide adequate respiratory protection:

1. Is the respiratBr intended for use during fire fighting?

a. If yes, only a self-contained breathing apparatus (SCBA) with a full facepiece operated in pressure demand or other positive pressure mode is recommended.

b. If no, proceed to Step 2.

2. Is the respirator intended for use in an oxygen-deficient atmosphere, i.e., less

• than 19.5% oxygen at sea level? (Refer to Subparagraph 1, page 21, for a discussion of oxygen deficiency.)

a. If yes, any type of SCBA or supplied-air respirator (SAR) with an aux i I i ary SCBA is reconimended. Aux i I i ary SCBA must be of sufficient duration to permit escape to safety if the air supply is interrupted.

If additional contamin~nts are present, proceed to Step 3.

8

b. If no, proceed to Step 3.

3. Is the respirator intended for use during emergency situations?

a. If yes, fwo types of respirators are recommended: a SCBA with a ful I facepiece operated in pressure demand or other positive pressure mode or an SAR wi th a fu I I facep i ece operated in pressure demand or other positive pressure mode in combination with an auxi I iary SCBA operated in pressure demand or other positive pressure mode. Auxiliary SCBA must be of sufficient duration to permit escap~ to safety if the air supply is interrupted.

b. If no, proceed to Step 4.

4. Is the contaminant regulated by the Department of Labor as a potential occupational carcinogen or identified by NIOSH as a potential human carcinogen in the workplace, and is the contaminant detectable in the atmosphere?

a. If yes, two types of respirators are recommended: a SCBA with a full facepiece operated in pressure demand or other positive pressure mode or an SAR with a ful I facepiece operated in pressure demand or other positive pressure mode in combination with an auxiliary SCBA operated in pressure demand or other positive pressure mode. Auxiliary SCBA must be of sufficient duration to permit escape to safety if the air supply is interrupted.

b. If no, proceed to Step 5.

5. Is the exposure concentration of the contaminant, as determined by acceptable industrial hygiene methods, less than the NIOSH REL or other applicable exposure limit? (Whenever a worker is given a respirator to use on a voluntary basis when ambient levels are below applicable limits, OSHA requires the implementation of a complete respiratory protection program, which includes medical evaluation, training, fit* testing, periodic environmental monitoring, and all other requirements in 29 CFR 1910.134.)

a. If yes, a respirator would not be required except for an escape situation. Proceed to Step 7 .

b. If no, proceed to Step 6.

6. Are conditions such that a worker who is required to wear a respirator can escape from the work area and not suffer loss of Ii fe or immediate or delayed irreversible health effects if the respirator fai Is, i.e., are the conditions not immediately dangerous to life or health (IDLH)? (Refer to Subparagraph 3, page 22, for additional information on IDLH's.)

9

a. If yes, conditions are not considered to be IDLH. Proceed to Step 7.

b. If no, conditions* are considered to be IDLH. Two types of respirators are recommended: a SCBA with a full facepiece operated in pressure demand or other positive pressure mode or an SAR with a ful I facepiece operated in pressure demand or other positive pressure mode in combination with an auxi I iary SCBA operated in pressure demand or other positive pressure mode. The auxiliary SCBA must be of sufficient duration to permit escape to safety if the air supply is interrupted.

7. Is the contaminant an eye irritant, or can the contaminant cause eye damage at. the exposure concentration? (Refer to Subparagraph 4, page 23, for a discussion of eye irritation .and damage.)

a. If yes, a respirator equipped with a ful1 facepiece, helmet, or hood is recommended. Proceed to Step 8.

b. If no, an orinasal respirator may still be an option; depending on the exposure concentration. Proceed to Step 8.

8. Divide the 8-hou( time-weighted average (TWA) exposure concentration for the contaminant (or maximum exposure concentration for a contaminant with a ceiling limit) determined in Step 5 by the NI0SH REL or other applicable exposure limit to determine the minimum protection factor required. For escape respirators, determine the potential for generation of a hazardous condition caused by an ace i dent or equipment fa i I u re,. If a potentially hazardous condition could occur or a minimum protection factor has been calculated, proceed to Step 9. *

9. If the physical state of the contaminant is a particulate (solid or liquid) during periods of respirator use, proceed to Step 10; if it is a gas or vapor, proceed to s*tep 11; if it is a combination of gas or vapor and particulate, proceed to Step 12.

10. Particulate Respirators 10.1. Is the particulate respirator intended only for escape purposes?

a. If yes, refer to Subparagraph 5, page 24, for a discussion and selection of "escape only" respirators. *

b. If no, the particulate respirator is intended for use during normal work activities. Proceed to Step 10.2.

10.2. A filter medium that wi I I provide protection against exposure to the particulate in question is recommended. (Refer to Subparagraph 9, page 29, for a. discussion on limitations of approvals for filter media.)

Proceed to Step 10'.3.

10

10.3. Respirators that have not been previously eliminated from Table 1 and that have APF's equal to or greater than the minimum protection factor determined in Step 8 are recommended. (Refer to Subparagraph 8, page 28, and Appendix D, page 50, for a discussion of protection factors, and to Subparagraph 9, page 29, for a discussion on limitations of filter approvals.) Maximum airborne concentrations for each level of respiratory protection can be calculated by multiplying the NI0SH REL or other applicable exposure I imit by the APF for that class of respirators.

Workers wearing respirators should meet the medical guidelines discussed in Subparagraph 10, page 30.

11. Gas/Vapor Respirators 11.1. Is the gas/vapor respirator intended for "escape only" purposes?

a. If yes, refer to Subparagraph 5, page 24, for a discussion on selection of "escape only" respirators.

b. If no, the gas/vapor respirator is intended for use during normal work activities. Proceed to Step 11.2.

11.2. Are the warning properties for the gas/vapor contaminant adequate at or below the NI0SH REL or other applicable exposure limit? (Refer to Subparagraph 6, page 26, and Appendix C, page 48, for additional information on requirements for adequate warning properties.)

a. If yes, proceed to Step 11.3.

b. If no, an air-purifying respirator equipped with an effective end-of-service-life indicator (ESLI.), a supplied-air respirator, or a self-contained breathing apparatus is recommended. (Refer to Appendix A, page 43, for add i t i ona I info rma t ion on app rova I of air-purifying respirators with ESLI 's.) Proceed to Step 11.4.

11.3. An air-purifying chemical cartridge/canister respirator is recommended that has a sorbent suitable for the chemical properties of the anticipated gas/vapor contaminant(s) and. for the anticipated exposure levels. (Refer to Subparagraph 7, page 27, for the recommended maximum use concentrations of air-purifying chem i ca I cartridge/canister respirators.) Proceed to Step 11.4.

11.4. Respirators that have not been previously eliminated from Table 2 and that have APF's equal to or greater than the minimum protection factor determined in Step 8 are recommended. (Refer to Subparagraph 8, page 28, and Appendix D, page 50, for a discussion of protection factors.) Maximum airborne concentrations for each class of respiratory protection can be calculated by multiplying the NI0SH REL or other applicable exposure I imit by the APF for that class of respirators. The calculated maximum use concentration limits should not exceed the limitations noted in Subparagraph 7, page 27. Workers wearing respirators should meet the medical guidelines discussed in Subparagraph 10, page 30.

11

12. Combination Particulate and Gas/Vapor Respirators 12.1. Is the combination respirator intended for "escape only" purposes?

a. If yes, refer to Subparagraph 5, page 24, for a discussion and select.ion of "escape only" respirators.

b. If no, the combination respirator is intended for use during normal work activities. Proceed to Step 12.2.

12.2. Does the gas/vapor contaminant have adequate warning properties at or below the NIOSH REL or other applicable exposure limit? (Refer to Subparagraph 6, page 26, and Appendix C, page 48, for additional information on requirements for adequate warning properties.)

a. If yes, proceed to Step 12.3.

b. If no, either an air-purifying respirator equipped with an effective ESLI (Appendix A, page 43), a supplied-air respirator, or a self-contained respirator i~ recommended. Proceed to Step 12.4.

12.3. An air-purifying chemical cartridge/canister is recommended that has a particulate prefi lter suitable for the specific type(g) of gas/vapor and particulate contaminant(s) and for the exposure concentrations. (Refer to Subparagraphs 7, page 27, and Subparagraph 9, page 29, for recommended maximum use concentrations and filter limitations.) Proceed to Step 12.4.

12.4. Respirators that have not been previously eliminated from Table 3 and that have APF's equal to or greater than the minimum protection factor determined in Step 8 are recommended. (Refer to Subparag.raph 8, page 28, and Appendix D, page 50, for a discussion of protection factors and Subparagraph 9, page 29, for a discussion on I imitations of filter approvals.) Maximum airborne concentrations for each level of respiratory protection can be calculated by multiplying the NIOSH REL or other applicable exposure limit by the APF for that class of respirators. The calculated maximum use concentration limits should not exceed the limitations noted in Subparagraph 7, page 27 .. Workers wearing respirators should meet the medical guide I ines discussed in Subparagraph 10, page 30.

12

Table 1.--Assigned protection factor classifications of respirators for protection against particulate exposures1 Assigned protection factor Type of respirator 5 Single-use (see definition in Glossary) or quarter mask2 respirator 10 Any ai r-pur i tying half-mask respirator including disposable3 (see definition in Glossary) equipped with any type of particulate filter except single use2,4 Any air-purifying ful I facepiece respirator equipped with any type of particulate fi lter5

• 25 Any supp I i ed-a i r resp i ra tor equipped with a ha If-mask and operated in a demand (negative pressure) mode2 Any powered air~purifying respirator equipped with a hood or helmet and any type of particulate fi lter4 Any supplied-air respirator equipped with a hood or helmet and operated in a continuous flow mode4

-50 Any a i *r-pu r i fy i ng ful' I facep i ece resp i ra tor equipped with a high efficiency fi lter2 Any powered air-purifying respirator equipped with a tight-fitting facepiece and a high efficiency fi lter4 Any supplied-air respirator equipped with a ful I facegiece and operated. in a demand (negative pressure) mode2 .

• Any supplied-air respirator .equipped with a tight-fitting facepiece and operated in a continuous flow mode4

• 1 Only high efficiency filters are permitted for frotection against particulates having exposure limits less than 0.05 mg/m .

2 The assigned protection factors (APF's) were determined by Los Alamos National Laboratories (LANL) by conducting quantitative fit testing on a panel of human volunteers [6].

3 An APF fac~or of 10 can be assigned to disposable particulate respirators if they have been properly fitted using a quantitative fit test.

4 APF's were based on workplace protection factor (WPF) data or laboratory data more recently reported than the LANL data [7-11, 14-17].

5 The APF was based on consideration of efficiency of dust, fume, and/or mist filters.

13

Table 1.--Assigned protection factor classifications of respirators for protection against particulate exposures1--continued Assigned protection factor Type of respirator 50 cont. Any self-contained respirator equipped with a ful I facegiece and operated in a demand (negative pressure) mode2 1,000 Any supp I i ed-a i r resp i ra tor equipped with a ha If-mask r and operated in a pressure demand or other positive pressure mode2 2,000 Any supplied-air respirator equipped with a ful I facepiece and operated in a pressure demand or other positive pressure mode2 10,000 Any self-contained respirator equipped with a full facepiece and operated in a pressure demand or other positive pressure mode2 Any supp I i ed-a i r resp i ra tor equipped with a fu 11 facepiece operated in a pressure demand or other positive pressure mode in combination with an auxiliary self-contained breathing apparatus operated in a pressure demand or other positive pressure mode2 1 Only high efficiency filters are permitted for protection against particulates having exposure limits less than 0.05 mg/m3.

2 The assigned protection factors (APF's) were determined by Los Alamos National Laboratories (LANL) by conducting quantitative fit testing on a panel of human volunteers [6].

3 An APF of 10 can be assigned to disposable particulate respirators if they have been properly fitted using a quantitative fit test.

4 The APF's were based on workplace protection factor (WPF) data or laboratory data more recently reported than the LANL data [7-11, 14-17].

5 The APF was based on cons i de ration of efficiency of dust, fume, and/or mist filters.

14

Table 2.--Assigned protection factor classifications of respirators for protection against gas/vapor exposures Assigned protection factor1 Type of respirator 10 Any air-purifying half mask respirator (including disposable) equipped with appropriate gas/vapor cartridges2 Any supplied-air respirator equipped with a half mask and operated in a demand (negative pressure) mode2 25 Any powered air-purifying respirator with a loose-fitting hood or helmet3 Any supplied-air respirator equipped with a hood or helmet and operated in a continuous flow mode3 50 Any air-purifying ful I facepiece respirator equipped with appropriate gas/vapor cartridges or gas mask (canister respirator)2 Any powered air-purifying respirator equipped with a tight-fitting facepiece and appropriate gas/vapor cartridges or canJsters3 Any supplied-air respirator equipped with a full facepiece and operated in a demand (negative pressure) mode2

• Any supplied-air respirator equipped with a tight-fitting facepiece operated in a continuous flow mode3 Any self-contained respirator equipped with a full facepiece and operated in a demand (negative pressure).

mode2 1,000 Any supplied-air respirator equipped with a half-mask and operated in a pressure demand or other positive pressure mode2 1 The assigned protection factor (APF) for a given class of air-purifying respirators may be further reduced by considering the maximum use concentrations for each type of gas and vapor air-purifying element.

2 The APF's were determined by Los Alamos National Laboratories (LANL) by conducting quantitative fit testing on a panel of human volunteers [6].

3 The APF's were based on workplace protection factor (WPF) data or laboratory data more recently reported than the LANL data [7-11, 14-17].

15

Table 2.--Assigned protection factor classifications of respirators for protection agai~st gas/vapor exposures--Continued Assigned protection

. factor 1 Type of respirator 2,000 Any supplied-air respirator equipped with a full facepiece and operated in a pressure demand or other positive pressure mode2 10,000 Any self-contained respirator equipped with a full facepiece and operated in a pressure demand or other positive pressure mode2 Any supplied-air respirator equipped with a full facepiece operated in a pressure demand or other positive pressure mode in combination with an auxiliary self-contained breathing apparatus operated in a pressure demand or 6ther positive pressure mode2 1 The assigned protection factor (APF) for a given class of air-purifying respirators may be further reduced by considering the maximum use concentrations for each type of gas and vapor air-purifying ~lement.

2 The APF's were detetmined by Los Alamos National Laboratories (LANL) by conducting quantitative fit testing on a panel of human volunteers [6].

3 The APF's were based on workplace protection factor (WPF) data or laboratory data more recently reported than the LANL data [7-11, 14-17].

16

Table 3.--Assigned protection factor classifications of respirators for protection against combination gas/vapor and particulate exposures1 Assigned protection factor2 Type of respirator 10 Any air-purifying half-mask respirator equipped with appropriate gas/vapor cartridges in combination with any type of particulate fi lter3 Any full facepiece respirator with appropriate gas/vapor cartridges in combination with a dust or mist or fume; dust and mist; or dust, mist, and fume fi lter4 Any suppl ied-ai.r respi_rator equipped with a half-mask and operated in a demand (negative pressure) mode3 25 Any powered air-purifying respirator equipped ~ith a loose-fitting hood or helmet5 Any supplied-air respirator equipped with a hood or helmet and operated in a continuous flow modes 50 Any air-purifying ful I facepiece respirator equipped with appropriate gas/vapor cartridges 1n combination with a*_,high efficiency filter or an appropriate canister incorporating a high efficiency fi lter3 Any powered air-purifying respirator with a tight-fitting facepiece equipped with appropriate gas/vapor cartridges in combination with a high efficiency filter or an appropriate canister incorporating a high efficiency fi lter5 Any supplied-air respirator equipped with a full facepiece and operated in a demand (negative pressure) mode3 .

1 Only high efficiency filters are permitted for protection against particulates having exposure I imits less than 0.05 mg/m3.

2 The assigned protection factor (APF) for a given class of air-puiifying respirators may be further reduced by considering the maximum use concentrations for each type of gas and vapor air-purifying element.

3 The APF's were determined by Los Alamos National Laboratories (LANL) by conducting quantitative fit testing on a panel of human volunteers [6].

4 The APF was based on cons i de ration of efficiency of dust, fume, and/or mist filters.

5 The APF's were based on workplace protection factor (WPF) data or laboratory data more recently reported than the LANL data [7-11, 14-17] .

. 17

Table 3.--Assigned protection factor classifications of respirators for protection against combination gas/vapor and particulate exposures1 __

Continued Assigned protection factor2 Type of respirator 50 cont. Any supplied-air respirator equipped with a tight-fitting facepiece and operated in a continuous flow mode5 Any self-contained respirator equipped with. a full facepiece and operated in a demand (negative pressure) mode3 1,000 Any supp I i ed-a i r resp i ra tor equipped wi th a ha If-mask and operated in a pressure demand or other positive pressure mode3 2,000 Any supplied-air respirator equipped with a ful I facepiece and operated in a pressure demand or other positive pressure mode3 10,000 Any self-contained respirator equipped with a ful I facep i ece and operated in a pressure demand or other positive pressure mode3 Any supplied-air respirator equipped with a full facepiece operated in a pressure demand or other positive pressure mode in combination with an auxi I iary self-contained breathing apparatus operated in a pressure demand or other positive piessure mode3 1 Only high efficiency filters are permitted for protection against particulates having exposure limits less than 0.05 mg/m3.

2 The assigned protection factor (APF) for a given class of air-purifying respirators may be further reduced by considering the maximum use concentrations for each type of gas and vapor air-purifying element.

3 The APF's were determined by Los Alamos National Laboratories (LANL) by conducting quantitative fit testing on a panel of human volunteers [6].

4 The APF was based on consideration of efficiency of dust, fume, and/or mist filters.

5 The APF's were based on workplace protection factor (WPF) data or laboratory data more recently reported than the LANL data [7-11, 14-17].

18

The Respirator Decision Logic Sequence is presented in Figure 1 in the form of a flow chart. This flow chart can be used to identify suitable classes of respirators for adequate protection against specific environmental conditions. Refer to the corresponding narrative section for additional information pertaining to a specific part of the flow chart.

Yes Yes Any SCBA or SAR with If other contaminants Auxiliary SCBA are present Yes A" or B" 0 Yes @

Carcinogen A" or B'

?

KEY: *CC-Contaminant Concentration EL-Exposure Limit ESLI-End of Service Life Indicator FF-Full Facepiece IDLH-lmmediately Dangerous Yes to Life or Health PD-Pressure Demand Respirator Use PF-Protection Factor Not Required Except for PFa-Assigned PF Escape Situtation PFmin-Minimum PF PP-Positive Pressure SC BA-Self-Contained

• Breathing Apparatus SAR-Supplied-Air Respirator No @ A' - SCBA with FF operated in PD or PP mode.

A" or B" B' - Type C supplied-air respirator (airline) operated in PD or PP mode with auxiliary SCBA.

c* - Escape respirator or gas mask with appropriate filter/sorbent (Subparagraph 5); if O, deficient, then SCBA.

Figure 1. - Flow Chart of Respirator Decision Logic Sequence 19

8 Air-Purifying 8 Orlnasal Style Chemical Sames as Respirator May Cartridge/Canister 10.3 Be Optional (Subparagraph 7) 9 Air-Purifying Respirator FF, 8

Select Respirator Type with ESLI (Appendix A) Based on PFa>PFmin Helmet, or Hood or any SAR, SCBA (Subparagraphs B, 9, 10, Only Option and Appendix D) 0 8 Select PFmln = CC/EL Particulate Type Filter (Subparagraph 9) sc*

yes 8c*

8c*

8 8 Air-Purifying Respirator with*

s Chemical Cartridge/

Same as ESLI (Appendix A) Canister with 10.3 or any Particulate Prefllter SAR, SCBA (Subparagraph 7)

Figure 1. - Flow Chart *of Respirator Decision Logic Sequence - Continued 20

D. Subparagraphs The following subparagraphs provide additional information to assist the reader in using the Respirator Decision Logic Sequence:

Subparagraph 1: Oxygen-Deficient Atmosphere The National Institute for Occupational Safety and Health (NIOSH) defines an oxygen-deficient atmosphere as any atmosphere containing- oxygen at a concentration below 19.5% at sea level [1] .. NIOSH certification of air-line or air-purifying r~spirators is limited to those respirators used in atmospheres containing at least 19.5% oxygen, except for those ai r-1 ine respirators equipped with auxiliary self-contained breathing apparatus (SCBA).

The minimum requirement of 19.5% oxygen at sea level provides an adequate amount of oxygen for most work assignments and includes a safety factor.

The safety factor is needed because oxygen-deficient atmospheres offer little warning of the danger, and the continuous measurement of an oxygen-deficient atmosphere is difficult.

At oxygen concent rat i ans be Iow 16% at sea Ieve I , decreased men ta I effectiveness, visual acuity, and muscular _coordination occur. At oxygen concen t rat ions be Iow 10%, Iass of consciousness may occur , and be Iow 6%

oxygen, death wi 11 result. Often only mi Id subjective changes are noted by individuals exposed to low concentrations of oxygen, and col lapse can occur without warning [2,3,4].

Since oxygen-deficient atmospheres are life-threatening, only the most reliable respirators are recommended; the most reliable respirators are the self-contained breathing apparatus or the supplied-air respirators with auxiliary self-contained units. Because a high protection factor is not necessary to ensu r*e an adequate supply of oxygen even in an atmosphere containing no oxygen, any certified self-contained unit is adequate. Al I aspects of a respiratory protection program must be instituted for these recommendations to be valid.

Subparagraph 2: Exposure Limits The majority of the OSHA PEL's were adopted from the American Conference of Governmental Industrial Hygienists .(ACGIH) TLVs pub I ished in 1968 .. The difficulty in changing PEL's through promulgation of standards when new taxi co logic information is identified has caused many standards to become outdated. The effectiveness of this decision logic is limited to the adequacy of the selected exposure limits in protecting the health of workers. Exposure I imi ts based on a thorough eva Iua ti on of mo re recent or extensive data should be given priority.

For al I chemicals that cause irritation or systemic effects but do not cause carcinogenic effects, it is currently believed that a threshold exposure 21

concentration exists such that virtually al I persons in the working population (with the possible exception of hypersensitive individuals) would experience no adverse health effects.

For many carcinogenic substances, most available data provide no evidence for the existence of a threshold exposure concentration below which the substance would be safe. As with noncarcinogenic substances, there appears to be a dose-response relationship for carcinogenic substances. If no threshold exists for a carcinogen, then there is no safe exposure concentration; however, lower exposures would be associated with lower risks.

For some c~rcinogens, NIOSH attempts to identify the lowest REL on the basis of the quantitative detection limit for the method used to monitor exposures. For other carcinogens, NIOSH does not identify a precise exposure limit but recommends instead that the employer control worker exposures to the lowest feasible limit.

Regardless of the selected exposure limit for a carcinogen, the best engineering controls and work practices should be instituted. Respirators should not be used as a substitute for proper control measures. When respiratory protect ion is required to achieve the lowest exposure concentration, then only the most effective respirators should be used. Two types of respirators are recommended: a fu 11 facep i ece SCBA operated in a pressure-demand or other positive pressure mode or a ful I facepiece supplied-air respirator (SAR) operated in a pressure-demand or other positive pressure mode in combination with a SCBA operated in a pressure demand or other positive pressure mode. The practicality of each situation must be assessed to determine the most technically feasible protection for the worker.

Other variables such as the specific situation, worker, or job may influence the selection of the appropriate exposure limit for a given contaminant.

For example, the effects of some hazardous substances may be increased due to exposure to other contaminants present in the workplace or the general environment or to medications or personal habits of the worker. Such factors, which would affect the toxicity of a contaminant, would not have been considered in the determination of the specific exposure limit. Also, some substances are absorbed by direct contact with the skin and mucous membranes, thus potentially increasing the total exposure.

Subparagraph 3: Immediately Dangerous to Life or Health (IDLH)

An IDLH. exposure condition is defined in this decision logic as one that poses a threat of exposure to airborne contaminants when that exposure is likely to cause death or immediate or delayed permanent adverse health effects or prevent escape from such an environment. The purpose of establishing an IDLH exposure level is to ensure that the worker can escape from a given contaminated environment in the event of failure of the respiratory protection equipment. The IDLH is considered a maximum level 22

above which only a highly reliable breathing apparatus providing maximum worker protection is permitted. Any appropriate approved respirator may be used to its maximum use concentration up to the IDLH concentration.

In establishing the IDLH concentration, the fol lowing con~itions must be assured:

a. The ability to escape without loss of life or immediate or delayed irreversible health effects. (Thirty minutes is considered the maximum time for escape so as to provide some margin of safety in calculating the IDLH.) .

b. The prevention of severe eye or respiratory irritation or other reactions that would hinder escape.

Sources of information for determining whether the exposure limit for a contaminant represents an IDLH condition are as fol lows:

a. Specific IDLH guidelines provided in the literature such as the American Industrial Hygiene Association (AIHA) Hygienic Guides and the NIOSH Pocket Guide for Hazardous Chemical Substances (previous editions were published jointly by NIOSH and OSHA), and/or

b. Human exposure and effects data, and/or c .. Animal exposure and effects data, and/or

d. Where such data specific to. the contaminant are lacking, toxicologic data from analogous substances and chronic animal exposure data may be considered.

Subparagraph 4: Eye Irritation Eye protection in the form of respirators with ful I facepieces, helmets, or hoods is required for routine exposures to airborne contaminants that cause any irritation to the mucous membranes of the conjunctivae or the cornea or cause any reflex tearing. Eye protection is required for contaminants that cause mi nor subjective effects as we 11 as for those that cause any damage*,

including disintegration and sloughing of conjunctiva! or corneal ep i the Ii um, edema, or u Icerat ion. NIOSH is not aware of any standards for gas-tight goggles that would permit NIOSH to recommend such goggles as providing adequate eye protection.

For escape, some1eye irritation is permissible if the severity of irritation does not inhibit the escape and if no irrever~ible scarring or ulceration of the eyes or conjunctivae is likely.

When data on threshold levels for eye irritation are insufficient, quarter-or half-mask respirators can be used, provided that the worker experiences 23

no eye discomfort ~nd no pathologic eye effects develop. Workers should be to Id that if any eye discomfort is experienced, they wi 11 be provided with respirators that have full facepieces, helmets, or hoods and that provide protection equivalent to the quarter- or half-mask respirators.

Subparagraph 5: Escape Apparatus Escape devices have a single function: to al low a person working in a no rma I I y safe env i ronmen t sufficient t i me to escape from sudden I y occurring respirato~y hazards. /f Escape devices can be separ~ted into two categories: air-purifying respirators and self-contained breathing apparatus. Air-purifiing respirators remove contaminants from the air by sorbent and/or filter media, but because they do not provide air, these respirators cannot be used in an oxygen-deficient atmosphere. Ai r-puri fy'ing escape respirators include the escape gas mask (canister) respirator, the gas mask (canister) respirator, and the filter self-rescuer. The escape gas mask consists of a half-mask or a mouthpiece respirator. The mouthpiece respirator can be used for short periods of time to escape from low concentrations of organic vapor or acid gas. The escape gas mask, which utilizes a half-mask, filters contaminants from the air . . These respirators may also be used to escape from low concentrations of organic vapor or acid gas. Escape gas mask respirators equipped with full facepieces can also be .used for escape from IDLH conditions but not from oxygen-deficient atmospheres. No air-purifying device is su i tab I e for escape from a potent i a 11 y oxygen-deficient atmosphere. The filter self-rescue unit is the mouthpiece device, which is designed to protect specifically against less than 1% carbon monoxide.

A set f-contained breathing apparatus (SCBA) provides air to the user for escape from oxygen-deficient environments. Escape SCBA devices are commonly used with fut I facepieces or hoods and, depending on the supply of air, are usually rated as 3- to 60-minute units. Self-contained self-rescuer (SCSR) devices have been approved by MSHA/N I OSH for escape from mines, but these devices may also have application in other simi tar environments. SCSR's are mouthpiece respirators that provide a source of oxygen-enriched air for up to 60 minutes. Al I SCBA devices can be used in oxygen-deficient atmospheres.

When selecting escape apparatus, careful consideration must be given to potential eye irritation. This consideration is important for determining whether a gas mask or SCBA equipped with a fut I facepiece should be selected rather than a device equipped with i half-mask or mouthpiece.

• The majority of gas masks or escape gas masks can be used in situations i nvo Iv i ng gas (es) , vapor ( s) , or part i cu I at es . For escape from particulate-contaminated environments, an air-purifying element must be selected that wi 11 provide protection against the given type of particulate. The information in Table 4 should be used to select the appropriate escape apparatus.

24

Table' 4.--Selection options for escape respirators Escape conditions Type of respirator Short distance to exit, no Any escape-gas mask1 (canister obstacles (no oxygen deficiency) respirator) or gas mask2 (canister respirator)

. Any escape self-contained breathing apparatus having a suitable service I ife3 Any acceptable device _for entry into emergency situations Long distance to exit Any gas mask2 or obstacles along the way (no oxygen deficiency) Any escape self-contained breathing apparatus having a suitable service life3 Any self-contained self-rescuer having a suitable service life Potential oxygen deficiency Any escape self-contained breathing apparatus _ having a suitable service life3 Any self-contained self-rescuer having a suitable service life 1 An escape gas mask is a resp i ra tor designed for use during escape on Iy from immediately - dangerous to life or health (IDLH) or non-lDLH atmospheres. It may consist of a ha If mask fa*cep i ece or mouthpiece, appropriate air-purifying .element for the contaminant, and associated connections. Maximum use concentrations for these types of respirators are designated by the manufacturer.

• 2 A gas mask consists of a ful I facepiece and either chin-style or front-or back-mounted can1sters with associated connections. Maximum use concentrations for canister ~ir-purifying elements are listed in Table 5.

3 Escape self-contained breathing apparatus can have - rated service I ives of 3 to 60 minutes. Al I acceptable devices for entry into emergency situations can also be used.

25

Subparagraph 6: Potential Warning Properties for Use With Cartridge/Canister Air-Purifying Respirators For the purpose of this decision logic, warning properties are defined according to odor, taste, eye irritation, or respiratory irritation.

Adequate warning properties imply that the gas or vapor of interest has a persistent odor or irritant effect at concentrations at or below the OSHA PEL or NI OSH REL. Recogn i t ion of an odor depends on a per son.' s sensory abi I ity to detect it. Since the range of odor recognition thresholds within a population is very large, odor recognition should not be relied on as the .*

only means for determining that a cartridge or canister is no longer effectively removing a contaminant from the air. A more detailed discussion of variability of odor detection within a population is provided in Appendix C. .

NIOSH recommends that the employer ensure that each worker who is required to wear an air-purifying* cartridge or canister respirator is capable of recognizing the odor of the substance of concern at a concentration at or be low the app Ii cab Ie exposure I im it, Such a de termination wi 11 necessitate that an odor screening test be conducted on each individual for each substance of concern in the particular workplace.

It is recognized that existing screening tests are subjective in nature and not sufficiently sensitive and that conducting screening tests for a group of workers exposed to severa I substances may be impract i ca I. There.fore, NIOSH knows of no compel ling reason not to develop quantitative service life test data to supplement or replace odor screening test results if it can be demonstrated that such a procedure wi I I afford the wearer a level of protection at least equivalent to that indicated by odor screening. Even when service life test data are used, the employer and the respirator wearer should not ignore the usefulness of sensory detection properties (for those who can detect the contaminant's presence) to serve as a warning that the cartridge/canister has failed or that the integrity of the respirator face seal has been compromised.

It is important to realize that 30 CFR 11 [specifical.ly, 30 CFR 11.90(b)

(note 4) for gas masks (canister respirators) and 30 CFR 11.150 (note 7) for chemical cartridge respirators], which provides for approval of air-purifying (organic vapor) devices, prohibits their approval for use against organic vapors with poor warning properties unless there is an OSHA  !"'

standard which permits their use. A more detailed discussion appears in Appendix C.

A recent policy decision by NIOSH al lows the use of respirators with effective end-of-service-life indicators for protection against contaminants with poor warning properties, provided that certain conditions are met.

These conditions are described in that pol icy statement, which is reproduced in Appendix A.

26

Subparagraph 7: Limitations of Respirators for Gases and Vapors Air-purifying respirators cannot be used in IDLH atmospheres or in atmospheres containing less then 19.5% oxygen by volume. Gas masks (canister respirators) may be used for escape if the atmosphere is not oxygen-deficient.

If, after the APF, is multiplied by the REL or other applicable exposure limit (APF X REL),- the product exceeds the IDLH value, then the IDLH value sha 11 be _the maximum use concentration. (See Tables l, 2, and 3.) In addition, there are maximum use concentrations associated w_ith al I gas and vapor air-purifying elements. (See Table 5.)

..J Air-purifying devices should not be allowed for either entry into or escape from* hazardous environments when supporting evidence exists to demonstrate that unreasonably short service life would occur at the maximum use concentration.

Where there is reason to suspect that a sorbent has a high heat of reactioh with a substance, use of that sorbent is not recommended. For such a substance, only non-oxidizable sorbents should be al lowed.

Air-purifying respirators cannot be used for protection against gases and vapors with poor warning properties unless the respirator is _approved with an effective ESLI. (See Appendix A.)

Although *limited in number, there are spe_cific air-purifying respirators that are approved by MSHA/NIOSH for protection against gases and vapors when respirators approved for a given class of contaminants (e.g., organic vapors) cannot be used due to sorbent deficiencies.

Subparagraph 8: Assigned Protection Factors (APF's)

APF's *(sometimes referred to in the literature as respirator protection factors), which appear in the 1975 and 1978 versions of the OSHA/NIOSH Respirator Decision Logic, in the 1980 American National Standards Institute (ANSI) standards for respiratory protection,_ and in all OSHA health standards, are based on quantitative fit testing (QNFT) of re*spirators [6].

(See definition of fit factors in Appendix D.) No data have been reported

.... in the literature to demonstrate that the results of QNFT are sufficiently indicative of the protection that a given respirator provides in the workplace. Recent studies by NIOSH [7-9] and others [10-12] have suggested that fit factors do not correlate with the workplace protection factors provided by powered air-purifying respirators (PAPR's) and negative pressure half-mask respirators. (See definition of workplace protection factors in Appendix D.)

27

Table 5.--NIOSH recommended maximum use concentrations (expressed in ppm) for gas and vapor air-purifying elements Classification of gas and vapor air-purifying elements Front- or Chin-style back-mounted Type of gas or vapor Cartridge(s) canister canister Organic vapors 1,000* 5,000t 20,000t Acid gases Sulfur dioxide (S02) 50 100* 100 Chlo_rine (Cl2) 10 25 25 Hydrochl~ric (HCI) 50 100 100 Ammonia (NH3) 300 500 500 Methyl amine (CH3NH2) 100 Carbon monoxide (CO) NA NA 1,500

• Maximum use concentration wi 11 be 1,000 ppm or the immediately dangerous to life or health (IDLH) value for the specific organic vapor, whichever is lower.

t Maximum use concentration for "entry into" wi 11 be I imited to the value listed or to the IDLH value for* the specific organic vapor, whichever is lower.

28

APF's that are sti 11 based on the fit factors determined by Los Alamos National Laboratories (LANL) can be used for those classes of respirators for which no WPF data or simulated workplace protection factor (SWPF) data are available. However, as WPF data are developed, these APF's. wi 11 be revised, as have the current APF's for powered air-purifying respirators (PAPR's) [7-9,11,14-16]. It should be noted that a number of studies

[17-20] on the workplace performance of respirators have appeared in the literature. However, the results of these studies are of little value for establishing APF's because their protocols did not require proper fit or correct use and conscientious wearing of the respirator while in-facepiece sampling was done. A notable exception is the study by Revoir (1974) [21].

When WPF data existed, NIOSH ut i Ii zed the point estimate equation proposed by Myers et al. [13] to help establish the APF's recommended in this decision logic. The point estimate equation is as fol lows:

protection factor (PF) = µg/SgZP where µg = the geometric mean of the measured WPF Sg = the geometric standard deviation of the measured WPF Zp = the value corresponding to the selected proportion (p) on the log-normal probabi I ity distribution When WPF data existed, NIOSH se I ected a cont i dence Ii mi t of p=O. 95. Thus for a given set of data and given class of respirators, NIOSH would expect that 95% of the WPF's would exceed the calculated point estimate value.

Despite the fact that some of the PF's have a statistical basis, they are sti II only estimates of an approximate level of protection. It must not be assumed that the numerical values of the APF's presented in this decision logic represent the absolute minimum level of protection that would be achieved for al I workers in al I jobs against al I respiratory hazards. The industrial hygienist or other professional responsible for providing respiratory protection or evaluating respiratory protection programs is therefore encouraged to evaluate as accurately as possible the actual protection being provided by the respirator.

Subparagraph 9: Particulate Filter Respirators MSHA/NIOSH particulate respirators are certified according to seven basic categories. These *categories consist of the fol lowing types of exposures:

29

• Dusts: Airborne exposure limit not less than 0.05 mg/m3 or 2 mppcf (see Appendix B);

• Fumes: Airborne exposure limit not less than 0.05 mg/m3 or 2 mppcf;

• Mists: Airborne exposure limit not less than 0.05 mg/m3 or 2 mppcf

• (see Appendix B);

• Dusts~ Fumes, a~d Mists: Airborne exposure limit less than 0.05 mg/m3 or 2 mppcf and radionuclides;

• Radon Oaughters;

• • *Asbestos-Containing Dusts and Mists (see Appendix B); and

• Single-Use Dust and Mist Respirators (see Appendix B).

Subparagraph 10:

Use Suggested Medi ca I Eva I uat ion and Criteria for Resp i rator The fo I lowing NIOSH recommendations a I low latitude for the physician in determining a medical evaluation for a specific situation. More specific guidelines may become available as knowledge increases regarding human stresses from the comp Iex interactions of worker heal th status, respirator usage, and job tasks. While some of the fol lowing recommendations should be part of any medical evaluation of workers who wear respirators, others are identified as being applicable for specific situations.

a. A Physician Should Make the Determination of Fitness to Wear a Respirator by Considering the Worker's Hea I th, the Type of Resp i rator, and the Conditions of Respirator Use.

The recommendation above satisfies OSHA regulations and leaves the final decision of an individual's fitness to wear a respirator to the person who is best qualified to evaluate the multiple clini9al. and other variables. Much of the clinical and* other data could be gathered by other personnel. It should be emphasized that the clinical exam.ination alone is only one part of the fitness'. determination and that collaboration with* foremen, industrial hygie1;1ists, and others may often be needed to better assess the work conditions and other factors that affect an individual's fitness to wear a respirator.

b. A Medical History and At Least a Limited Physical Examination are Recommended.

The medical history and/ physical examination should emphasize the evaluation of the cardiopulmonary system and should elicit any history of respirator use. The history is an important tool in medical diagnosis and can be used to detect most problems that might require further I 30

evaluation. Objectives of the phys i ca I exam i na t ion shou Id be to con f i rm the clinical impression based on the hi story and to detect important medical conditions (such as hypertension) that may be essentially asymptomatic.

c. While Chest X-Ray and/or Spirometry May Be Medically Indicated in Some Fitness Determinations, These Should Not Be Routinely Performed.

In most cases, the hazardous situations requiring the wearing of respirators wi I I also mandate periodic chest X-ray and/or spirometry for exposed workers. When such information is available, it should be used in the determination of fitness to wear respirators. (See Recommendation h, page 33.)

Routine chest X-rays and spirometry are not recommended solely as data for determining if a respirator should be worn. In most cases, with an essentially normal clinical examination (history and physical) these data

• are unlikely to influence the respirator fitness determination; additionally, the X-ray would be an unnecessary source of radiation exposure to the worker. Chest X-rays in general do not accurately reflect a person's cardiopulmonary physiologic status, and limited studies suggest that mi Id to moderate impairment detected by spi rometry would not preclude the wearing of respirators in most cases. Thus it is recommended that chest X-ray and/or spirometry be done only when clinically indicated. (See Appendix E, page 52, for further discussion on the pulmonary effects of wearing respirators.)

d. The Recommended Periodicity of Medi ca I Fi tness De term i nat ions Vari es According to Several Factors but Could Be as Infrequent as Every 5 Years.

Federal or other applicable regulations shal I be fol lowed regarding the frequency of respirator fitness determinations. The guidelines for most work conditions for which respirators are required are shown in Table 6 .

These guidelines are similar to those recommended by ANSI, which recommends annual determinations after age 45 [22]. The more frequent examinations with advancing age relate to the increased prevalence of most diseases in older people. More frequent examinations are recommended for individuals performing strenuous work involving the use of SCBA. These guide I ines are based on clinical judgment and, I ike the

_, other recommendations in this section, should be adjusted as clinically indicated.

e. The Resp irater Wearer Shou Id Be Observed During a Tri a I Period to Evaluate Potential Physiological Problems In addition to considering the physical effects of wearing respirators, the physician should determine if wearing a given respirator would cause extreme anxiety or claustrophobic reaction in the individual. This could be done during training, while the worker is wearing the respirator and 31

is engaged in*some exercise that approximates the actual work situation.

Present regulations state that a worker should be provided the opportunity to wear the respirator "in normal air for a long familiarity period ... " [23]. This trial period should also be used to evaluate the abi Ii ty and tolerance of the worker to wear the respirator [24]. This trial period need not be associated with respirator fit testing and should not compromise the effectiveness of the vital fit testing procedure.

Table &.--Suggested frequency of medical fitness determinations*

• Worker age (years)

<35 35 - 45 >45 Most work condi-tions requiring respirators Strenuous work Every 5 yrs Every 3 yrs Every 2 yrs Every 18 mos 1-2 yrs Annually conditions with SCBAt

• Interim testing would be needed i.f changes i.n health status occur.

t SCBA = self-contained breathing apparatus f . Examining Physicians Shou Id Rea I i ze that the Main Stress of Heavy Exercise While Using a Respirator Is Usually on the Cardiovascular System and that Heavy Respirators (e.g. , . Se If-Contained Atmosphere Supp Iy i ng)

Can Substantially Increase this Stress. Accordingly, Physicia~s May Want To Consider Exercise Stress Tests with Electrocardiographic Monitoring When* Heavy Resp i rat ors Are Used, When Cardi ovascu Iar. *Risk Factors Are Present, or When Extremely Stressful Conditions Are Expected.

• Some respirators may weigh up to 35 pounds and may increase workloads by 20 percent. Although a lower activity level could compensate for this added stress [25], a lower activity I eve I. might not a I ways be poss i b I e.

Physicians should also be aware of other added stresses, such as heavy protective clothing and intense ambient heat, which would increase the worker's cardiac demand. As an extreme example, firefighters who use SCBA inside burning bui !dings may work at maximal exercise levels under life-threatening conditions. In such cases, the detection of occult card.iac disease, which might manifest itself during heavy stress, may be important. Some authors have either recommended stress testing [26] or 32

at least its consideration in the *fitness determination [22].

Ki lbom [26] has recommended stress testing at 5-year intervals for firefighters below age 40 who use SCBA and at 2-year intervals for those aged 40-50. He further suggested that firemen over age 50 not be al lowed to wear SCBA.

Exercise stress testing has not been recommended for medical screening for coronary artery disease in the general population [27,28]. It has an estimated sensitivity and specificity of 78% and 69%, res*pectively, when the disease is defined by coronary angiography [27,29]. In a recent 6-year prospective study, stress testing to determine the potential for heart attack indicated a positive predictive value of 27% when the prevalence of disease was 3 1/2% [30,31]. While stress testing has limited effectiveness in medical screening, it could serve to detect those ind i vi dua Is who may not be ab I e to comp I ete the heavy exercise required in some jobs .

• A definitive recommendation regarding exercise stress testing cannot be made at this time.

g. An Further research may determine whether this. is a useful tool in selected circumstances.

Important Concept Is that "Genera I Work Lim i tat ions and Restrictions Identified for Other Work Activities Also Shall Apply for Respirator Use" [22].

In many cases, if a worker is ab I e to do an assigned job without an increased risk to health while not wearing a respirator, the worker will in most situations not be at increased risk when performing the same job while wearing a respirator.

h. Because of the Variability in the Types of Respirators, Work Condit ions, and Workers' Heal th Status, Many Employers May Wish to Designate Categories of Fitness To Wear Respirators, Thereby Exe I ud i ng Some Workers from Strenuous Work Situations Involving the Wearing of Respirators.

Depending on the various circumstances, there could be several permi ss i b I e categories of respirator usage. One poss i b I e scheme wou Id consist of three overal I categories: ful I respirator use, no respirator use, and limited respirator use including "escape only" respirators. The latter category

• excludes heavy respirators and strenuous. work conditions. Before identifying the conditions that would be used to classify workers into various' categories, it is critical that the physician be aware that these conditions have not been validated and are presented only for consideration. The physician should modify the use of these conditions based on actual experience, further research, and individual worker sensitivities. The physician may wish to consider the fol lowing conditions in selecting or permitting the use of respirators:

33

• History of spontaneous pneumothorax;

• Claustrophobia/anxiety reaction;

• Use of contact lens (for some respirators);

• Moderate or severe pulmonary disease;

• Angina pectoris, significant arrhythmias, recent myocardial infarction;

• Symptomatic or uncontrolled hypertension; and

• Age.

It seems unlikely that wearing a respirator would play any significant role in causing lung damage such as pneumothorax. However, without good evidence that wearing a respirator would not cause such lung damage, it may be prudent to prohibit the individual with a history of spontaneous pneumothorax from wearing a respirator.

Moderate lung disease is defined by the I ntermountai n Thoracic Society

[32] as

• being a forced expiratory vo I ume in one second (FEV1) divided by the forced vital capacity (FVC) (i.e., FEV1/FVC) of 0.45 to 0.60 or an FVC of 51 to 65% of the predicted FVC value. Similar arbitrary limits cou Id be set for age and hypertension. It wou Id seem mo re reasonab I e, however, to combine several risk factors into an overal I estimate of fitness to wear respirators under certain conditions. Here the judgment

• and clinical experience of the physician are needed. Even many impaired workers would be able to work safely while wearing* respirators if they could control their own work pace, including having sufficient time to rest.

Conclusion Individual judgment is needed in determining the factors affecting an individual's fitness to wear a respirator. While many of the preceding guidelines are based on limited evidence, they should provide a useful starting point for a respirator fitness screening. program. Further research is needed to. validate these recommendations and others currently in use. Of particular interest would be laboratory studi.es involving physiologically impaired individuals and *field studies conducted under actual. day-to-day work conditions.

34

REFERENCES

1. Code of Federal Regulations, Title 30, Part 11, revised July 1, 1986.

2. Guyton AC. Textbook of medical physiology, 3rd ed, Philadelphia: W.B.

Saunders Co., 1966, p. 578.

3. Clayton GD, Clayton FE, ed. Patty's industrial hygiene and toxicology, 3rd ed, Vol 1, New York~ John Wiley & Sons, 1978.

4. A guide to industrial respiratory protection. Cincinnati: U.S.

Department of Hea I th, Education, and We I fare, Pub Ii c Hea I th Service, Centers for Disease Control, National Institute for Occupational Safety and Health, 1976; HEW (NIOSH) publication no.76-189.

5. Goodman LS, Gi Iman A. The pharmacological basis of therapeutics. 3rd ed, New York: The Macmi I Ian Co, 1968, p. 897.

6. Hyatt EC. Respirator protection factors. New Mexico: Los Alamos scientific laboratory of the University of California, informal report no. LA-6084-MS, 1976.

7. Myers WR, Peach MJ I I I, Al lender J. Workplace protection factor measurements on powered air-purifying respirators at a secondary lead smelter--test protocol. Am Ind Hyg Assoc J 1984;45(4):236-41.

8. Myers WR, Peach MJ 111, Cutright K, lskander W. Workplace protection factor measurements on powered air-purifying respirators at a secondary lead smelter--results and discussion. Am Ind Hyg Assoc J 1984;45(10):681-88.

• 9. Myers WR, Peach MJ 111. Performance measurements on a powered air-purifying respirator made during actual field use in a silica bagging operation. Ann Occup Hyg 1983;27(3):251-59.

10. Dixon SW, Nelson TJ. Workplace protection factors for negative pressure half-mask facepiece respirators. J Int Soc Respir Prot 1984;2(4):347-61.

11. Dixon SW, Nelson TJ, Wright JE. Program protection factor study on the 3M W316 Airhat'. Presented at the .American Industrial Hygiene Conference, May 22, 1984, Michigan. Detroit: E.I. du Pont de Nemours &

Co.

12. Hinton JJ. Reliability of quantitative fit protection factors in assessing face-to-facep i ece sea Is. [Unpub Ii shed thesis]. Houston, TX:

University of Texas, Health Science Center, 1980.

13. Myers WR, Lenhart SW, Campbel I D, Provost G. [Letter]. Am Ind Hyg Assoc J 1983;44(3):B25-26.

35

14. Myers WR,* Peach MJ 111, Cutright K, lskander W. Field test of powered air-purifying respirators at a battery manufacturing facility. J Int Soc Respir Prot 1984;4(1):62-89.

15. Lenhart SW, Campbel I DL. Assigned protection factors for two respirator types based upon workplace performance testing. Ann Occup Hyg 1984;28(2):173-82.

16. Linauskas SH, Kalos F. Study of efficiency and current use of respiratory protective devices. [Report prepared for the Atomic Energy Control Board. Ottawa, Canada]. Atomic Energy of Canada Limited, 1984.

17. Bentley RA, Bostock GJ, Longson DJ, Roff MW. Determination of the quantitative fit factors of various types of respiratory protective equipment. J Int Soc Respir Prot 1984;2(4):313-37.

18. Moore DE; Smith TJ. Measurement of protection factors of chemical cartridge, half-mask respirators under working conditions in a copper smelter. Am Ind Hyg Assoc J 1976;37(8):453-58.

19. Toney CR, Barnhart WL. Performance evaluation of respiratory protective equipment used in paint spraying operations, NIOSH Technical Information, HEW publication no. (NIOSH)76-177, 1976.

20. Smith TJ, Ferrel I WC, Varner MO, Putnam RD. Inhalation exposure of cadmium .workers: effects of respirator usage. Am Ind Hyg Assoc J 1980;41:624-28.

21. Revoir WH. Respirators for protection against cotton dust. Am Ind Hyg Assoc J 1974;35(8):503-10.

22. American National Standards Institute, Inc. American national standard for respirator protection-respirator use-physical qualifications for personnel, ANSI 288.6-1984. New York: ANSI, Inc., 1984, pp. 7-15.

23. Code of Federal Regulations, Title 29, Part 1910, Section 134(e)(5),

revised Juty 1, 1986.

24. Harber P. Medical evaluation for respirator use. J Occup Med 1984;26(7):496-502.

25. Manning JE, Griggs TR. Heart rates in fire fighters using I ight and heavy breathing equipment: similar near-maximal exertion in response to multiple work load conditions. J Occup Med 1983;25(3):215-18.

26. Ki I born A. Phys i ca I work capacity of firemen. Scand J Work Environ Health 1980;6:48-57.

27. Weiner DA, Ryan TJ, McCabe CH, et al. Exercise stress testing:

correlations among history of angina, ST-segment response and prevalence 36

of coronary-artery disease in the coronary artery surgery study. (CASS).

N Engl J Med 1979;301(5):230-35.

28. Epstein SE. Limi tat i ans of e Iect rocard i ograph i c exercise testing

[Editorial]. N Engl J Med 1979;301(5):264-65.

29. Nicklin D, Balaban DJ. Exercise EKG in asymptomatic normotensive subjects [Letter to the editor]. N Engl J Med 1984;310(13):852.

30. Giagnoni E, Secchi MB, Wu SC, et al. Prognostic value of exercise EKG testing in asymptomatic normotensive subjects. N Engl J Med 1983;309(18):1085-89.

31. Fol Ii G. Exercise EKG in asymptomatic normotensives subjects [Reply' to letter. to the editor]. N Engl J Med 1984;310(13):852-53.

32. Kanner RE, Morris AH, ed. Clinical pulmonary function testing: a manual of uniform laboratory procedures for the intermountairi area. 1st ed, Salt Lake City, Utah: lntermountain Thoracic Society, 1975.

33. Amoore JE, Hautala E. Odor as an aid to chemical safety: odor thresholds compared with threshold limit values and volati Ii ties for 214 industrial chemicals in air and water dilution. J Appl Toxicol 1983;3(6):272-90.

34. Williams FT. Photometric measurement of respirator quantitative fit test protection factors and their interpretation, use and meaning, Dynatech Frontier Technical Note, 108-0008, 1978.

35. Halperin WE, Ratcliffe JM, Frazier TM, Becker SP, Schulte PA. Medical screening in the workplace: proposed principles. J Occup Med 1986;28(8):547-52.

36. Raven PB, Dodson AT, Davis TO. The physiological* consequences of wearing industrial respirators: a review. Am Ind Hyg Assoc J 1979;40(6):517-34.

37. James RH. Breathing resistance and dead space in respiratory protective devices. U.S. Department of Health, Education, and Welfare, National Institute for Occupational Safety and ~ealth, Cincinnati, Ohio, October 1976.

38. Gee JBL, Burton G, Vassa 11 o C, Gregg J. Effects of externa I airway obstruction on work capacity and pulmonary gas exchange. Am Rev Respir Dis 1968;98:1003-12.

39. Hodous TK, Petsonk L, Boyles C, Hankinson J, Amandus H. Effects of added resistance to breathing during exercise in obstructive lung disease. Am Rev Respir Dis 1983;128:943-48.

37

40. Raven PB, Jackson AW, Page K, et a I. The phys i oIog i ca I responses of -

mild pulmonary impaired subjects while using* a "demand" respirator during rest and work. Am Ind Hyg Assoc J 1981;42(4):247-57.

41. Hodous TK, Boyles C, Hankinson J. Effects of industrial respirator wear during exercise in subjects with restrictive lung disease. Am Ind Hyg Assoc J 1986;47:176-80.

42. Altose MD, McCauley WC, Kelsen SG, Cherniack NS. Effects of hypercapnia and inspiratory flow-resistive loading on respiratory activity in chronic airways obstruction. J Clin Invest 197~;59:500-07.

• 43. Bentley RA, Griffin OG, Love RG, Muir DCF, Sweetland KF. Acceptable levels for breathing resistance of respiratory apparatus. Arch Environ Health 1973;27:273-80.

44. Love RG, Muir DCF, Sweetland KF, Bentley RA, Griffin OG. Acceptable levels for the breathing resistance of respiratory apparatus: results for men over the age of 45. Br J Ind Med 1977;34:126-29.

45. Deno NS, Kamon E, Kiser OM. Physiological responses to resistance breathing during short and prolonged. exercise. Am Ind Hyg Assoc. J 1981;42(8):616-23. .

46. Raven PB, Davis TO, Shafer CL, Linnebur AC. Maximal stress test performance while wearing a self-contained breathing apparatus. J Occup Med 1977;19(12):802-06.

47. Craig FN, Blevins WV, Cummings G. Exhausting work limited by external resistance and inhalation of carbon dioxide. J Appl Physiol 1970;29(6):847-51.

48. Stemler FW, Craig FN. Effects of respiratory equipment on endurance in hard work. J. Appl Physiol 1977;42:28-32.

49. Myhre LG, Holden RD, Baumgardner FW, Tucker D. Physiological limits of firefighters .. *Air Force Schoo I of Aerospace Medicine, Brooks AFB, TX, ESL-TR-79-06, 1979.

50. James R, Dukes-Dobos F, Smith R. Effects of respirators under heat/work conditions. Am Ind Hyg Assoc J 1984;45(6):399-404.

51. Hermansen L, Vokac Z, Lereim P. Respiratory and circulatory response to added air flow resistance during exercise. Ergonomics 1972;15(1):15-24.

52. Meyer E, Gurtner HP, Scherrer M. Phys i o log i ca I apprai sa I of a new respirator with positive pressure. Pneumonology 1975;153:61-72.

53. Dahlback GO, Balldin UI. Physiological effects of pressure demand masks during heavy exercise. Am Ind Hyg Assoc J 1984;45(3):177-181.

38 '

54. Arborel ius M, Dahl back GO, Data P-G. Cardiac output and gas exchange during heavy exercise with a positive pressure respiratory protective apparatus. Scand J Work Environ Health 1983;9:471-477.

55. Bjurstedt H, Rosenhamer G, Lindborg B, Hesser CM. Respi.ratory and circulatory responses to sustained posi*tive-pressure breathing and exercise in man. Acta Physiol Scand 1979;105:204-14.

56. Black LF, Hyatt RE. Maxi ma I respiratory pressures: _norma I va Iues and relationship to age and sex. Am Rev Respir Dis 1969;99:696-702.

57. Bates DV, Macklem PT, Christie RV. Respiratory function in disease: an introduction to the integrated study of the lung, 2nd ed, Philadelphia:

W.B. Saunders Co., 1971, p. 43.

58. Raven PB, Bradley 0, Rohm-Young D, McClure FL, Skaggs B. Physiological response to "pressure-demand" respirator wear. Am Ind Hyg Assoc J 1982;43(10):773-81.

59. Harber P, Tamimie RJ, Bhattacharya A, Barber M. Physiologic effects of respirator dead space and resistance loading. J 0ccup Med 1982;24(9):681-84.

60. Petsonk EL, Hancock J, Boyles C. Physiologic effects of a self-contained self-rescuer. Am Ind Hyg Assoc J 1983;44(5):368-73.

61. Morgan WP. Psychological problems associated with the wearing of industrial respirators: a review: Am Ind Hyg Assoc.J 1983;44(9):671-76.

62. Morgan WP. Psychological problems associated with the wear of industrial respirators. J Int Soc Respir Prot 1983;1:67-108.

63. Ronk R, White MK. Hydrogen su I fide and the probabi Ii ties of "i nha Iat ion" th rough a tympani c membrane defect. J 0ccup Med 1985;27(5):337-40.

64. Cantekin El, Bluestone CD, Saez CA, Bern SA. Airflow through the eustachian tube. Ann 0tol 1979;88:603-612.

65. daRoza RA, Weaver C. Is it safe to wear contact lenses with a ful 1-facepiece respirator? Lawrence Livermore Nati ona I Laboratory manuscript UCRL-53653, 1985, pp. 1-3.

39

IV. GLOSSARY The following definitions of terms are provided to assist in the understanding and application of this decision logic.

ASSIGNED PROTECT ION FACTOR (APF) : See PROTECT I.ON FACTOR.

BREAKTHROUGH:. The penetration of challenge material(s) through a gas or a vapor air-purifying element. The quantity or extent of breakthrough during service Ii fe testing is often referred .to as the percentage of the input con cent ration.

DISPOSABLE RESPIRATORS: A respirator that is discarded after the end of its recommended period of use, after excessive resistance or physical damage, or when odor breakthrough or other warning indicators render the respirator unsuitable for further use.

DUST: A solid, mechanically produced particle with a size ranging from submicroscopic to macroscopic.

EMERGENCY RESPIRATOR USE SITUATION: A situation that requires the use of respirators due to the unplanned generation of a hazardous atmosphere (often of unknown composition) caused by an accident, mechanical failure, or other means and that requires evacuation of personnel or immediate entry for rescue or corrective action.

ESCAPE GAS MASK: A gas mask that consists of a half-mask facepiece or mouthpiece, a canister, and associated connections and that is designed for use during escape only from hazardous atmospheres (see Subparagraph 5).

ESCAPE ONLY RESPIRATOR: Respiratory devices that are designed for use only during escape from hazardous atmospheres.

FILTERING FACEPIECE: A particulate respirator with a f i I ter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium. (See SINGLE-USE DUST or DUST and MIST RESPIRATORS and DISPOSABLE RESPIRATORS.)

FIT FACTOR: A quantitative measure of the fit of a specific respirator facepiece to a particular individual. (For further discussion of fit factors, refer to Appendix D.)

FUME: A solid condensation particulate, usually of a vaporized metal.

GAS: An aer i form fluid that is in a gaseous state at standard temperature and pressure.

IMMEDIATELY DANGEROUS TO LIFE OR HEALTH (IDLH): Acute respiratory exposure that poses an immediate threat of loss of Ii fe, immediate or 40

delayed irreversible adverse effects on health, or acute eye exposure that would prevent escape from a hazardous atmosphere.

MIST: A liquid condensation particle.

ORINASAL RESPIRATOR: A respirator that covers the nose and mouth and that generally consists of a quarter- or half-facepiece.

PLANNED or UNPLANNED ENTRY into an I DLH ENVIRONMENT, .AN ENVIRONMENT OF UNKNOWN CONCENTRATION of HAZARDOUS CONTAMINANT, or an ENVIRONMENT of UNKNOWN COMPOSITION: A situation in which respiratory devices are recommended to*

provide adequate protection to workers entering an area where the contaminant concentration is above the IDLH or is unknown.

POTENTIAL OCCUPATIONAL CARCINOGEN: Any substance, or combination or mixture of substances, which causes an increased incidence of benign and/or malignant neoplasms, or a substantial decrease in the latency period between exposure and onset of neoplasms in humans or in one or more experimental mammalian species as the result of any oral, respiratory, or dermal exposure, or any other exposure which results in the induction of tumors at a site other than the site of administration. This definition also includes any substance that is metabolized into one or more potential occupational carcinogens by mammals (29 CFR 1990.103, OSHA Cancer Policy).

PROTECTION FACTORS (See Appendix D):

ASSIGNED PROTECTION FACTOR (APF): The minimum anticipated protection provided by a properly functioning respirator or class of respirators to a given percentage of*properly fitted and trained users.

SIMULATED WORKPLACE PROTECTION FACTOR (SWPF): A surrogate measure of the workplace protection provided by a respirator.

WORKPLACE PROTECT I ON FACTOR (WPF) : A measure of the protection provided in the workplace by a properly functioning respirator when correctly worn and used.

RECOMMENDED EXPOSURE LIMIT (REL): An a.:_ or 10-hou r t i me-weighted ave rage (TWA) or cei I ing (C) exposure concentration recommended by NIOSH that is based on an evaluation of the health effects data.

SERVICE LIFE: The length of time required for an air-purifying element to reach a specific effluent concentration. Service life is determined by the type of substance being removed, the concentration of the substance, the ambient temperature, the specific element being tested (cartridge or canister), the flow rate resistance, and the selected breakthrough value.

The service Ii fe for a self-contained breathing apparatus (SCBA) is the period of time, as determined by the NIOSH certification tests, in which adequate breathing gas is supplied.

41

SINGLE-USE DUST or DUST AND MIST RESPIRATORS: Respi raters approved for use against dusts or mists that may cause pneumoconiosis and fibrosis.

VAPOR: The gaseous state of a substance that is solid or liquid at temperatures and pressures normally encountered.

42

V. APPENDICES APPENDIX A. NIOSH POLICY STATEMENT ON APPROVAL OF AIR-PURIFYING RESPIRATORS WITH END-OF-SERVICE-LIFE INDICATORS Department of Health and Human Services Public Health Service Centers for Disease Control National Institute for Occupational Safety and Health NIOSH/MSHA TESTING AND CERTIFICATION OF AIR-PURIFYING RESPIRATORS WITH END-OF-SERVICE-LIFE INDICATORS Agency: National Institute for Occupational Safety and Health (NIOSH)

Action: Notice of Acceptance of Applications for Approval of Air-Purifying Respirators with End-of-Service-Life Indicators Summary: 30 CFR 11; Sec. 11.150 states that NIOSH and MSHA may, after a review of the effects on wearers' health and safety, approve respirators for gases and vapors not specifically listed in that section. The current regulations also permit the use of "window indicators" for gas masks to warn the wearer when the canister wi 11 no longer remove a contaminant

[11.102-5(c)(2)]. Although indicators are not mentioned in Subpart L, Chemical Cartridge Resp*irators, there is nothing in the regulations which explicitly prohibits their use. A* NIOSH policy to allow end-of-service-life indicators (ESLl's) on air-purifying respirators for gases and vapors with adequate warning properties has already been established (Letter to All Respirator Manufacturers from Dr. Elliott Harris, June 18, 1975).

Use of ESLI 's on chemical cartridge respirators for use against gases _and vapors with poor warning properties could also be approved, because 30 CFR 11; Sec. 11.150; footnote 7 states:

"Not for use against gases or vapors with poor warning properties (except where MSHA or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) .... " Thus, air-purifying respirators with ESLl's could be approved for substances such as acrylonitri le, because the OSHA acrylonitri le standard permits the use of chemical cartridge respirators.

Under the present regulations, NIOSH can also require "any additional requirements deemed necessary to es tab Ii sh the qua Ii ty, effectiveness, and safety of any respirator used as protection against hazardous atmospheres"

[30 CFR 11; Sec. 11.63 (c)]. NIOSH must notify the applicants in writing of these additional requirements [30 CFR _11; Sec. 11.63 (d)].

• The purpose of this notification is to inform respirator manufacturers and users of the NIOSH requirements for approving air-purifying respirators with 43

either effective passive or active ESLI 's for use against gases and vapors with adequate warning properties or for use against gases and vapors with inadequate warning properties whenever there is a regulatory standard already permitting the use of air-purifying respirators.

For additional information, contact: Chief, Certification Branch, 944 Chestnut Ridge Road, Morgantown, WV 26505, (304) 291-4331.

Supplemental Information Because human senses are not foolproof in detecting gases and vapors and "

because many gases and vapors found in the workplace do not have adequate warning properties, NIOSH has been investigating alternate means of detection for respirator wearers. In 1976, NIOSH adopted its current policy which allows* acceptance of applications for certification of air-purifying respirators, provided that the respirators are equipped with active ESLl's for use against gases and vapors with poor warning properties and are not specifically listed in 30 CFR 11.

An active ESLI is defined as an indicator that invokes an automatic and spontaneous warning signal (e.g., flashing I ights, ringing bel Is, etc.). An active indicator does not require monitoring by the wearer although a passive indicator (normally color change indicator) does.

During the past severa I years, NI OSH has received notices of concern from respirator manufacturers, regulatory agencies, and general industry regarding the lnstitute's policy of accepting only active ESLI 's for certification. At the October 1983 Mine Health Research Advisory Council (MHRAC) meeting, NIOSH presented a document briefing on IIConsideration of Use of End-of-Service-Life Indicators in Respiratory Protective Devices,"

and requested that MHRAC provide recommendations to the Institute with regard to the appropriateness of the use of both active and passive ESLI 's.

MHRAC asked their Respirator Subcommittee to review the issue.

The Respirator Subcommittee held a public meeting in Washington, D.C., on December 19,

• 1983, to solicit comments from interested parties. The Subcommitte~ reviewed the comments and then reported back to the ful I committee at the February 2, 1984, MHRAC meeting*. Based on the pub I ic comments, the Subcommittee a I so suggested a few additions or modifications be made to the N IOSH proposed eva I uat ion er i ter i a. NIOSH incorporated' the recommendations. MHRAC also recommended that active and passive ESLI 's are appropriate for use with respiratory protective devices provided that criteria are established for their certification and use to ensure that the user is not exposed to increased risk as a consequence of relying upon such ESLI Is. .

In order for NIOSH to determine the potential effects of ESLI 's on user safety and health, NIOSH recommends that al I applications for approval of gas and vapor respirators with ESU's contain the fol lowing information:

44

CRITERIA FOR CERTIFICATION OF END-OF-SERVICE-LIFE INDICATORS An applicant for certification of an ESLI for use against substances with poor warning properties must provide NIOSH with the fol lowing information:

1. Data demonstrating that the ESLI is a reliable indicator of sorbent depletion <i 90% of service life). These shat I include a flow-temperature study at low and high temperatures, humidities, and contaminant concentrations which are representative of actual workplace conditions where a given respirator will be used. A minimum of two contaminant levels must be uti I ized: the exposure limit (PEL, REL, TLV, etc.) and the exposure I imit multiplied by the assigned protection factor for the respirator type.

2. Data on desorption of any impregnating agents used in the indicator, including a flow-temperature study at low and high temperatures and humidities which are representative of actual workplace conditions where

• a given respirator wi I I be used. Data shal I be sufficient to demonstrate safe levels of desorbed agents.

3. Data on the effects of industrial interferences which are commonly found in workplaces where a given respirator wi 11 be used. Data should be sufficient to show which interferences could impair the effectiveness of the indicator and the degree of impairment, and which substances wi II not affect the indicator.

4. Data on any reaction products produced in the reaction between the sorbent and the contaminant gases and vapors, -including the concentrations and toxicities of such products.

- 5. Data which predict the storage life of the indicator. (Simulated aging tests wi I I be acceptable) .

. In addition to the foregoing, al I passive ESLI 's shal I meet the fol lowing criteria:

1. A passive ESLI shat I be placed on the respirator so that the ESLI is visible to the wearer.

2. If the passive indicator utilizes color change, the change shall be such that it is detectable to people with physical impairments such as co tor b Ii ndness.

3. If the passive indicator uti I izes color change, reference colors for the initial color of the indicator and the final (end point) color of the indicator shal I be placed adjacent to the indicator.

45

Al I ESLI 's shal I meet the fol lowing criteria:

1. The ESLI shal I ~ot interfere with the effectiveness of the face seal.

2. The ESLI shall not change the weight distribution of the respirator to the detriment of the facepiece fit.

3. The ESLI shal I not interfere with required lines of sight.

4. Any ESLI that is permanently installed in the respirator facepiece shal I be capable of withstanding cleaning and a drop from a height of 6 feet. Replaceable ESLI must be capable of being easily removed and shal I also be capable of withstanding a drop fr,om a height of 6 feet.

5. A respirator with an ESLI shall still meet all other applicable requirements set forth in 30 CFR 11.

6. If the ESLI uses any electrical components, they shall conform to the provisions of the National Electrical Gode and be "intrinsically safe."

Where permissibility is required, the respirator shall meet the requirements for permissibi Ii ty and intrinsic safety set forth in 30 CFR 18, Subpart D. Also, the electrical system shal I include an automatic warning mechanism that indicates a loss of power.

7. Effects of industrial substances interferences which are commonly found where a given respirator wi I I be used and which hinder ESLI performance, sha I I be i dent i f i ed. Substances which a re common Iy found where the respirator is to be used must be investigated. Data sufficient to indicate whether the performance of the respirator would be affected must be submitted to NI0SH. The user shal I be made aware of use conditions that could cause false positive and negative ESLI responses.

8. The ESLI shal I not create any hazard to the wearer's health or safety ..

9. Consideration shall be given to the potential impact of common human physical impairments on the effectiveness of the ESLI.

46

APPENDIX B. NIOSH POLICY STATEMENT ON USE OF SINGLE-USE AND DUST AND MIST RESPIRATORS FOR PROTECTION AGAINST ASBESTOS June 21, 1984, OSHA Public Hearings Under Title 30, Code of Federal Regulations, Part 11 (30 CFR 11), NIOSH is required to test and certify respirators within the categories specified therein when such devices are submitted to NIOSH by applicants. Currently, 30 CFR 11, Subpart K defines a number of dust, fume, and mist respirators which may be used for protection against certain hazardous particulate atmospheres. Among the respirators defined in Subpart Kare single-use dust respirators designed as respiratory protection against pneumoconiosis-

. producing and fibrosis-producing dusts, or dusts and mists. Subpart K I ists asbestos as one of the dusts against which the single-use dust respirator is designed to protect [Subpart K, Sec. 11.130(H)]. Al though at the time of the promulgation of Subpart K, it may have been assumed appropriate to list asbestos as a fibrosis-producing particulate against which the single-use

• disposable respirator could be reasonably expected to provide adequate pro,ection, NIOSH is no longer confident that such an assumption is reasonable because asbestos is also a potent carcinogen.

The current requirements as (specified in 30 CFR 11) for app'roval of a single-use dust respirator or dust and mist respirator do not include any tests with fibrous challenge aerosol. NIOSH is currently in the process of doing a comprehensive revision of 30 CFR 11 and intends to address the issue of appropriate respiratory protection for use against asbestos, and to require that any respirator for which such approval is sought be proven to provide effective protection against asbestos. NIOSH may change the regulations included in 30 CFR 11 only in accordance with procedures set forth in the Administrative Procedures Act. In the interim, NIOSH wi 11 continue to consider applic*tions for approval of single-use and replaceable dust/mist respirators for use against asbestos only because of the legal requirement in the current approval regulations. However, NIOSH does not.

recommend the use of such respirators where exposures to asbestos may occur because such a recommendation would not be prudent based on the occupational hea I th r i sk.

This policy position is contained in "The Statement of the National Institute* for Occupational Safety and Health--The Public Hearings on Occupational Exposure to Asbestos."

47

APPENDIX C. ODOR WARNING: BACKGROUND INFORMATION It is important to realize that 30 CFR 11 prohibits the use of MSHA/NIOSH approved a i r-pu r i fy i ng (organic vapor) respirators for protection against organi~ vapors with poor warning properties unless there is an OSHA standard that permits such use. Specifically, 30 CFR 1f, Section 11.90(b), footnote 4 gives the standards for gas masks (canister devices), whi.le 30 CFR 11, Section 11.150, footnote 7 gives the standards for chemical cartridge respirators. Thus the "organic vapor respirator" shal I be approved only for organic vapors with adequate warning properties. In addition, the requirement for adequate warning properties also applies to al I MSHA/NIOSH-approved air-purifying respirators for protection against organic gases and vapors.

A recent policy decision by NIOSH al lows the use of respirators for protection against contaminants with poor warning properties, provided *that certain conditions are met. These conditions are outlined in the policy statement in Appendix A. MSHA/NIOSH approval may be granted for a respirator designed for use against gases and vapors with poor warning properties if the respirator incorporates an effective end-of-service-life indicator (ESLI).

However, unless the respirator incorporates an ESLI, wearers of air-purifying chemical cartridge/canister respirators must rely on adequate warning properties to alert them to the breakthrough of the sorbent in the cartridge or canister. Amoore and Hautala [33] have noted:.

The ability of members of the population to detect a given ad.or is strongly influenced by the innate variabi I ity of different persons' olfactory powers, their prior experience with that odor, and by the degree of attention they accord to the matter.

Amoore and Hautala [33] found that on the average, 95% of a population will have a personal odor threshold that lies within the range from about one-sixteenth to sixteen times the reported mean "odor threshold" for a substance. That is, about 2.5% of a population wi 11 be able to detect a substance's odor at concentrations less than one-sixteenth of the "odor threshold" for a substance. Correspondingly, about 2.5% of the individuals will need to be exposed to concentrations exceeding by a factor of 16 the "odor threshold" in order to perceive the odor. Thus for many substances the width of distribution of personal odor threshold is over two orders of magnitude of concentration. The "odor thresholds" reported in the literature generally are the median values for wide population distributions. Also, 50% of prospective respirator wearers can detect a substance's odor only at levels that must exceed the reported "odor threshold," and about 15% cannot detect the odor at -levels that exceed the "odor threshold" by fourfold [33].

• OSHA incorporated* into the lead standard a new isoamyl acetate qualitative fit test protocol, developed by Du Pont, which requires odor thresh.old 48

screening [29 CFR 1910.1025, Appendix D (l)(A)]. Du Pont realized that a qualitative fit test depending on odor. recognition would be ineffective if every individual were not first screened for the ability to detect the odor of isoamyl acetate at some minimum concentration. This is also true for detection of the odor of the gas or vapor used to a Iert the wearer of.

sorbent element (cartridge or canister) breakthrough. Thus NI0SH recommends screening tests for workers who wear air-purifying gas or vapor respirators to determine their ability to detect the odor below the exposure limit for that gas or vapor.

49

APPENDIX D. PROTECTION FACTOR: BACKGROUND-INFORMATION The U.S. Bureau of Mines referred to the term "Decontamination Factor" in their Approval Schedule 218, first issued in 1965, and defined it to be "the ratio of the concentration of dust, fume, or mi;st present in the ambient atmosphere to the concentration of dust, fume, or mist within the facepiece while the respirator is being worn." The decontamination factor is now referred to as the respirator protection _factor. The original definition and application given in schedule 218 has been somewhat generalized over the years.

The prote~~ion factor of a respirator is an expression of performance based on the ratio of two measured variables, C1 and Co. The variable C1 is defined only as the measured concentration of a contaminant inside the respirator facepiece cavity, and Co is defined only as the measured contaminant concentration outside. the respirator facepiece. The relationship between these two variables can be expressed not only as the protection factor efficiency [ (Co-C 1)/Col -

(ColC1) but also as the penetration (C1IC0) or The 'protection factor can be related to the penetration (p) and efficiency

( E) as fo I I ows :

PF= Cote, = 1/p = 1/(1-E)

A further implicit condition on the PF function is that C1 < Co; therefore, the PF wil I always be greater than unity.

Protection factor assessments are made almost exclusively on man/respirator systems, while penetration and efficiency assessments are made only on component parts of the respirator system. It is important to recognize that on a man/respitator system, the measured variable C1 becomes a comp I icated function of many individual sources of penetration (e.g., air-pur*itying e I ement pen et ration, exha I at ion va Ive pen et ration, face sea I penetration; and other inboard penetration) and those environmental conditions that would effect penetration__, To deal with the multiple methods for determining and applying protection factors, a number of definitions have been proposed

[13]. These definitions, described below in greater detai I than in the*

Glossary, are as fol lows:

ASSIGNED PROTECTION FACTOR (APF): A spec i a I app Ii cation . of the genera I protection factor concept, APF is defined as a measure of the minimum anticipated workplace level of respiratory protection that would be provided by a properly functioning respirator or class of respirators to a percentage of properly fitted and trained users. The maximum specified use concentration for a respirator is generally determined by multiplying the exposure limit for the contaminant by the protection factor assigned to a specific class of respirators [13].

50

SIMULATED WORKPLACE PROTECTION FACTOR (SWPF): A surrogate measure of the workplace protection factor (WPF) of a respirator, SWPF differs from the WPF

• only in that it is measured in a laboratory simulation of a workplace setting rather than in the actual workplace. The definitions and restrictions of Co and C1 are as described for the WPF. For laboratory protection factor testing to reliably estimate WPF's, a relationship must be demonstrated between the two tests. No such relationship has been identified in the literature. Until such a relationship can be shown to exist, the laboratory protection factor is of questionable use in determining or predicting the WPF [13].

WORKPLACE PROTECTION FACTOR (WPF): A measure of the actual protection provided in the workplace under Jhe conditions of that workplace by a

<;I properly functioning respirator when correctly worn and used, WPF is defined as the ratio of the estimated contaminant concentration outside the respirator facepiece (Co) to the contaminant concentration inside the respirator facepiece (C1). The sampling restrictions placed on Co and

• - C1 are that both Co and C1 should be TWA samples taken simultaneously while the respirator is being properly worn and used during normal work activities. In practice, the WPF would be determined by measuring the concentration inside and outside the facepiece during the activities of a normal workday [13].

• FIT FACTOR: A special application of the protection factor ratio that represents a quantitative measure of the fit *of a particular respirator facepiece to a particular individual, the fit factor is defined under the conditions of quantitative fit testing as the aerosol concentration in the test chamber (Co) divided by the penetration that occurs through the respirator -face* se~I. interface (C1) [34]. For C1 to reflect only face seal leakage, high *efficiency filters [greater than 99.97% efficient against 0.3 µm aerodynamic mass median diameter (AMMO) dioctylphthalate aerosol] are installed on the respirator. It is assumed that either no leakage or only a negligible amount of leakage into the Jacepiece occurs through the exhalation valve or any source other than the* face seal. The fit factor is measured on a complete respirator worn* by a test subject who fol lows a regimen of slow head movements, deep breathing, and talking; a polydispersed oi I mist or sodium chloride aerosol is used that has an AMMO of approximately 0.6 +/- 0.1 µm (with a geometric standard deviation of approximately 2 to 2.4).

51

APPENDIX E.. MEDICAL ASPECTS OF WEARING RESPIRATORS: BACKGROUND INFORMATION In recommending medical evaluation criteria for respirator use, one should apply rigorous decision-making principles [35], using knowledge of screening test sensitivity, predictive value, etc. Unfortunately, many ~aps in knowledge in this area exist. The problem is comp I icated by the large variety of respirators, their conditions of use, and individual differences in the physiologic and psychologic responses to them. For these reasons, the preceding guide I ines (see Subparagraph 10) are to Pe considered as informed suggestions rather tl;lan established NI0SH pol icy recommendations.

The fol lowing information is intended primarily to assist the physician in developing medical evaluation criteria for respirator use.

Health Effects of Wearing Respirators Brief descriptions of the health effects associated with wearing respirators are summarized below. Interested readers are referred to recent reviews for more detailed analyses of the data [36,37].

Pulmonary: In general, the a~ded i.nspi ratory and expiratory resistances and dead space of most respirators cause an increased ti da I vo I ume and decreased respiratory rate and ventilation (including a smal I decrease in alveolar ventilation). These respirator effects have usually been smal I both among healthy individuals and, in limited studies, among individuals with impaired lung function [38-42]. This generalization is applicable to

.most respirators meeting Federal regulations when resistances (particularly expiratory resistance) are low [1,43,44]. While most studies report minimal physiologic effects during submaximal exercise, the resistances commonly lead to reduced endurance and reduced maximal exercise performance [45-49]. The dead space of a respirator (reflecting the amount of expired air that must be rebreathed before fresh air is obtained) tends to cause increased ventilation. At least one study has shown substantially increased ventilation with a full-face respirator, a type which can have a large effective dead space [50]. However, the net effect of a respirator's added resistances and dead space is usually a smal I decrease in ventilation [39,45,46-48,51].

The potential for adverse effects; particularly decreased cardiac output, from the positive pressure feature of some respirators has been reported

[52]. However, several recent studies suggest that this is not a practical concern, at least not in healthy individuals [53-55].

Theoretically, the increased fluctuations in thoracic pressure while breathing with a respirator might constitute an increased risk to subjects with a history of spontaneous pneumothorax. Few data are available in this area. While an individual is using a negative pressure respirator with relatively high resistance during very heavy exercise, the usual maximal peak negative oral pressure during inhalation is about 15-17 cm of water [53]. Similarly, the usual maximal peak positive oral pressure 52

during exhalation is about 15-17 cm of water, which might occur with a respirator in a positive pressure mode, again during very heavy exercise

[53]. By comparison, maximal positive pres~ures, such as those during a vigorous cough, can generate 200 cm of water pressure [56]. The norma I maxima I negative p I eura I pressure at fu 11 i nsp i ration is -40 cm of water

[57], and normal subjects can generate -80 to -160 cm of negative water pressure [56]. Thus while vigorous exercise with a respirator does alter pleural pressures, the risk of barotrauma would seem to be substantially les*s than that of ,the cough maneu,ver.

In some asthmatics, an asthmatic attack may be exacerbated or induced by a variety of factors including exercise, cold air, and stress, all of which may be associated with wearing a respirator. Wh i I e most asthmatics who are able to control their condition should not have problems with respirators, a physician's judgment and a field. trial may be needed in selected cases.

Cardiac: The added work of breathing from respirators is smal I and could not be detected in several studies [38,39]. A typical respirator might double the work of breathing from 3 to 6% of the oxygen consumption, but this is probably not of clinical signi f ica,nce [38]. In concordance with this view is the finding of several studies that at the same workloads heart rate does not change with the wearing of a respirator

[39 ,54 ,58-60].

In contrast, the added cardiac stress due to the weight of a heavy respirator may be considerable. A self-contained breathing apparatus

• (SCBA), particularly one that uses compressed air cylinders, may weigh up to 35 pounds. Heavier respirators have been

• shown to reduce maximum externa I work loads by 20% and s im i lar ly increase heart rate at a given submax ima I work load [46]. In addition, -it shou Id be appreciated that many uses of SCBA (e.g., for firefighting and hazardous waste site work) also necessitate the wearing of 10-25 pounds of protective clothing .

Raven et al. [40,58] found significantly higher systolic and/or diastolic blood pressures during exercise for persons wearing respirators (although increases were minima I, i .e., 5.10 mmHg sys to Ii c, 0-2 mmHg di asto Ii c).

Arborelius et al. [54] did not find significant differences for persons wearing respirators during exercise.

Body Temperature: Proper- regulation of body temperature is primarily of concern with the closed circuit,. self-contained breathing apparatus that produces oxygen vi a an exothermic chemi ca I reaction. Inspired air within these respirators may reach 120°_F (49°C), thus depriving the wearer of a minor cooling mechanism and causing discomfort. Obviously this can be more of a problem with heavy exercise and when ambient conditions and/or protective clothing further reduce the body's ability to lose heat. The increase in heart rate due to increasing temperature represents an additional cardiac stress.

53

Closed-circuit breathing units of any type have the potential for heat stress since warm expired gases (after exothermic carbon dioxide removal with or without oxygen_ addition) are rebreathed.- Respirators with large dead space also have this potential problem, again because of partial rebreathing of warmed expired air [50].

Diminished Senses: Respirators may reduce visual fields, decrease voice clarity and loudness, and decr~ase hearing. Besides the potential for reduced productivity, these .effects may result in reduced industrial safety. These factors may also contribute to a general feeling of stress

[61].

Psychologic: This important topic is discussed in recent reviews by Morgan [61,62]; There is Ii tt le doubt that virtually everyone suffers some discomfort when wearing a respirator. The large variabi I ity and the subjective nature of the psycho-physiologic aspects of wearing a respirator, however, make studies and specific recommendations di ff i cu It. Fit testing obviously serves an important add it i ona I function in providing a trial to determine if the wearer can psychologically tolerate the respirator. General experience indicates that the great majority of workers can tolerate respirators and that experience aids in this to I erance [62]. However, some ind iv i dua Is are Ii ke ly to r-emai n psychologically unfit for wearing respirators.

Local Irritation: Allergic skin reactions may occur occasionally from wearing a respirator, and skin occlusion may cause irritation or exacerbation of preexisting conditions such as pseudofo 11 i cu Ii tis barbae. Facial discomfort from the pressure of the mask may occur, particularly when the.fit is unsatisfactory~

In addition to the health effects associated with wearing respirators (described above) specific* groups of.respirator wearers may be affected by the fol lowing factors:

Perforated Tympanic Membrane: While inhalation of toxic materials through a perforated tympanic membrane (ear drum) is possible, recent evidence indicates that the airflow would be mini.mal and rarely if ever of clinical importance [63,64]. In highly toxic or unknown atmospheres, use of positive pressure respirators should ensure adequate protection [63].

Contact Lens: Contact lenses are generally not recommended for use with respirators, although little documented evidence exists to support this viewpoint [65]. Severa I po_ss i b I e reasons for this recommendation are noted below: *- *

a. Corneal irri"tation or abrasion might occur with the exposure.

• This would, of course, be a problem primarily with quarter- and half-.face masks, especially with *particulate exposures.

• However, exposures could occur with full-face respirators due to leaks or 54

inadv~sable removal of the respirator for any reason. While corneal irritation or abrasion might also occur without contact lenses, their presence is known to substantially increase this risk.

b. The loss or misplacement of a contact lens by an individual wearing a respirator might prompt the wearer t6 remove the respirator, thereby resulting in exposure to the hazard as well as to the potential problems noted in "a." above.

c. The constartt airflow of some respirators, such as powe~ed air-purifying respirators (PAPR) or continuous flow air-line respirators, might irritate a contact lens wearer .

55

• U.S. GOVERNMENT PRINTING OFFICE: 1994: 550-147/00030

DHHS (NIOSH) Publication No.87-108

(j)

~~~ _W_Y_O_M_I_N_G_M_I_N_I_N____________C_I_A_T_I_O_N_

} ;2 ,t_8 AREA CODE 307 September~1998 '98 SEP 28 PJ ._ PHONE 635-0331 54 FAX 778-6240 EMAIL wma@tcd.net U.S. Nuclear Regulatory Commission HITCHING POST INN Washington, D.C. 20555-001 P.O. Box 866

, fAFF Cheyenne, Wyoming Attention: Rulemakings and Adjudications Staff 82003

Subject:

Wyoming Mining Association Comments on "Respiratory Protection and Controls to Restrict Internal Exposures", 10 CFR Part 20

Reference:

Federal Register, 63 FR 38511, July 17, 1998, Proposed Rule

• The Wyoming l\1ining Association (WMA) is an industry group that includes members from the uranium production industry in Wyoming and Nebraska. The Wyoming Mining Association (WMA) is a statewide mining organization whose mission is to communicate information on the significance of a healthy mining industry. WMA will promote the overall industry through active involvement in the legislative process, regulatory policy development, public education, and relevant public policy forums.

The WMA represents bentonite, coal, gold, trona and uranium companies and the mining associates (vendors, suppliers and contractors) in Wyoming. Wyoming leads the nation in the production of bentonite, coal, soda ash produced from trona, and uranium. Our membership consists of 32 mining companies, 12 l supply and 5 electrical utility companies. Wyoming trona mines produce 90% of the national soda ash. Wyoming coal mines produce about 25% of the nations supply of coal.

Based upon a thorough review of the Proposed Rule to revise 10 CFR 20, Subpart H, "Respiratory Protection and Controls to Restrict Internal Exposures", WMA believes that certain changes, if implemented in their current fonn, would have potential negative impacts on NRC-licensed uranium production facilities. The attached comments discuss the aspects of the Proposed Rule that are of concern to the WMA.

The \\'MA appreciates the opportunity to comment on the Proposed Rule.

Sincerely.

WYOMING MINING ASSOCIATION Ma.-ion Loomis Executive Director SEP 3 O 1998 Acknowledged bYcard ....- - - - -

U.S. NUCLEAR REGULATORY ISSI RULEMAKINGS &ADJUDICATI S STAFF OFACE OF THE SECRETAR OF THE COMMISSIO Stati

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Wyoming Mining Association Comments on Proposed Rule 10 CFR Part 20, Subpart H Respiratory Protection Introduction The following comments are submitted in response to the Proposed Rule to revise 10 CFR Part 20, Subpart H "Respiratory Protection and Controls to Restrict Internal Exposures" (63 FR 38511, July 17, 1998). These comments are based upon a review by the membership of the Wyoming Mining Association (WMA). WMA members are active in the uranium mining and milling industry and in the reclamation of shutdown facilities in Wyoming and Nebraska.

Use of Engineering Controls The current §20.1701 states that 'The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment or ventilation) to control the concentrations of radioactive material in air. The proposed §20.1701 contains the same sentence with the addition of "decontamination" as an example of an engineering control and that the word "practical" is replaced by the word "practicable". The proposed change of the word "practical" represents a significantly higher level of effort and cost licensees would have to expend before using respiratory protection.

1

Practical is defined as "capable of being put to use" or "useful". Practicable is defined as "possible to practice or perform" or "feasible". The words are not interchangeable. The example of the difference in the meanings given in Webster's is useful in this context. The modern, low slung, high-speed automobile was practicable long before improved roads and fuels made it practical.

By proposing to change the level of effort that a licensee must expend before using respiratory protection, NRC has removed the reasonable approach to protection from airborne radioactive material. Just because an approach is feasible, it does not mean that it is also practical. This new approach to implementation of engineering controls is also apparent in the Draft Regulatory Guide DG-8022, Revision 1 to Regulatory Guide 8.15.

The proposed change could present a significant additional cost to licensees. Many uranium facilities are operating equipment and systems that were designed and installed decades ago.

Under the existing rule, practical engineering controls have been implemented to control exposures from these systems at considerable expense. By requiring licensees to implement any theoretical, feasible control before resorting to respiratory protection, NRC is not allowing a cost-effective approach to ALARA. A stringent interpretation of this rule could result in requiring licensees to install expensive new equipment or replace entire components or systems if these efforts would theoretically reduce airborne radioactive material concentrations. For many uranium licensees, this is not a practical approach to radiation protection, especially given the low exposures already achieved by the industry.

NRC has recently recognized the difference that the use of these two words presents in the level of effort to maintain doses ALARA. In a Final Rule to revise 10 CFR §20.1101 (b), NRC has changed the word "practicable" to "practical" in the requirement to use procedures and controls to achieve occupational doses and doses to members of the public ALARA.

2

Recommendation: WMA recommends that the current use of the word "practical" in

§20.1701 be retained to be consistent with the Final Rule changing §20.1 lOl(b). WMA agrees that the addition of the word "decontamination" to the examples of engineering methods available to control concentrations of radioactive materials in air is a method that licensees should consider. Therefore, WMA recommends the NRC revise §20.1701 to state:

'The licensee shall use, to the extent practical, process or other engineering controls (e.g.,

containment, decontamination, or ventilation) to control the concentration of radioactive material in air':

Fit Testing The new §20.1703(c)(6) requires fit testing that achieves a fit factor greater than or equal to ten times the Assigned Protection Factor (APF) for negative pressure devices. Achieving the specified fit factor would be required in order to use the APFs. The new §20.1003 defines fit factor as "... a quantitative measure of the fit of a particular respirator to a particular individual" (emphasis added). Therefore, the proposed fit testing requirements would effectively preclude the use of APFs where qualitative fit testing (QLFT) methods are used.

NRC in the new §20.1003 defines fit test as "... a test, quantitative or qualitative, to evaluate the fit of a respirator on an individual and to determine the fit factor" (emphasis added). The definition of fit factor as a "quantitative measure" in §20.1003 is inconsistent with this definition of fit test. Fit factor is typically defined as the ratio of the concentration of the challenge atmosphere in ambient air to its concentration inside the respirator. By definition, this ratio is quantitative and not qualitative. Licensees cannot determine the quantitative fit factor by using qualitative techniques.

3

The proposed rule follows the ANSI requirements in ANSI 288.2-1992 concerning fit factors greater than or equal to 10 times the APF. However, ANSI includes the provision that ".. .if a qualitative test is used, only validated protocols are acceptable". ANSI requires that these validated QLFT protocols be designed to assess fit factors ten times greater than the APF.

288.2-1992 further requires that fit tests be performed in accordance with ANSI 288.10. As of this time, ANSI 288.10 is neither approved nor published. 288.2-1992 states that the protocol given in the OSHA Asbestos Standard (29 CFR §1910.1001) should be followed until such time as 288.10 is available. In Draft Regulatory Guide DG-8022, NRC recommends the use of the QLFT protocols contained in OSHA' s new respiratory protection standard (29 CFR

§1910.134, Appendix A) to develop fit test procedures. The QLFT protocols contained in

§ 1910.134 are generally similar to those contained in § 1910.1001. However, none of these referenced OSHA standards define a "validated" QLFT protocol or provide the maximum fit factor that can be obtained through their use.

This proposed rule would have significant impacts on smaller licensees with limited respirator use that cannot afford the elaborate and expensive quantitative fit testing (QNFT) equipment.

QNFT equipment involves sophisticated booths and instrumentation for measuring the concentration of the challenge aerosol in the booth and in ihe mask. Masks must be specifically adapted for fit testing. Personnel administering the tests must be specially qualified and trained.

Most WMA licensees have a few occasional respirator users and could not justify the expense of QNFT equipment and trained testing personnel. Contract fit testing at larger facilities, if available, would raise issues ofliability and compatibility of equipment and procedures.

If the rule were finalized as proposed, the practical affect may be to prevent smaller licensees from applying the APF for respirator usage. Licensees would continue to issue respirators to employees in accordance with the ALARA requirements of 10 CFR §20.1702. By permitting the use of respirators to limit internal exposure, licensees would be required to implement the 4

provisions of the new §20 .1703. Therefore, the licensee would have to meet all of the regulatory requirements for an acceptable respiratory protection program. The only difference would be the licensee's inability to take credit for the protection afforded by the respirator. The result would be that licensees that do not have the capability to perform QNFT procedures would assign internal doses that are well in excess of those actually received by the individual employee.

Recommendation: NRC should revise the proposed rule to specifically allow the use of validated QLFT protocols. NRC has referenced ANSI and OSHA for use by licensees to determine acceptable QLFT protocols and to determine the fit factors afforded by these protocols. However, the fit factor information is not available from the referenced ANSI or OSHA standards. Therefore, if NRC proceeds with requiring the fit test factor to exceed the APF by a factor no less than ten, NRC should also provide the acceptable fit factors achievable by these validated protocols.

Footnote c to Appendix A There is apparently an error in this footnote. The footnote states ':4.ir purifying respirators with APF ~ 100 must be equipped with particulate Jilters that are at least 99 percent efficient. Air purifying respirators with APF ~ JOO must be equipped with particulate .filters that are at least 99. 97 percent efficient. As written with both symbols indicating :::; the footnote implements conflicting requirements for respirators with an APF :::;100.

Recommendation: WMA assumes that the second sentence should state "Air purifying respirators with APF ~100 must be equipped with particulate filters that are at least 99.97 percent efficient".

5

Chemical & Metallurgical Products 0 SRAM 0

OOCt<ETEO IIStff:C SYLVANIA "98 SEP 23 P4 :l 8 OF-~ i. r RULL.

September 21, 1998 ADJuc

• Secretary DOCKET U. S. Nuclear Regulatory Commission 0

AOPOSED RUlE PR  :/0 Washington, DC 20555-0001 (IP3FI< 3'851/j Attention: Rulemakings and Adjudications Staff

Subject:

Osram Sylvania Products, Inc., Docket No. 040-00185, License No.

STB-281, Comments on "Respiratory Protection and Controls to Restrict Internal Exposures", 10 CFR Part 20.

Reference:

Federal Register, 63 FR 38511, July 17, 1998, Proposed Rule.

In the proposed modification to 10 CFR 20.1703(c)(2), "Use of Individual Respiratory Protection Equipment", Osram Sylvania notes that the USNRC has made the following change (shown in italics):

"If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material, the licensee shall

• implement and maintain a respiratory protection program that includes surveys and bioassays, as necessary, to evaluate actual intakes."

The USNRC's reasons for changing the wording of this provision from "as appropriate" to "as necessary" were not explained. Whether the term "as appropriate" or "as necessary" is used, OSRAM SYLVANIA Products, Inc. applauds the agency for acknowledging in the regulations that bioassays are not required in all cases.

A case in point is during the use of Y-class thorium compounds. The Annual Limit on Intake (ALI) for 232 Th is one of the very lowest of those listed in Appendix B of 10 CFR

20. In addition, thorium dioxide, a widely used thorium compound, exhibits extremely low solubility in body fluids. These facts, coupled with the relative low detection capability for thorium by conventional internal radiation monitoring methods (i.e.,

whole body or organ counting, urine bioassay and fecal bioassay), clearly make the use of bioassays for evaluating intakes by respirator users unnecessary when intakes are expected to be below the ALI.

SEP 2 5 1998 Acknowledged by card----

Tele phone (717) 268-5000 Hawes Street OSRAM SYLVANIA Prod ucts Inc. www.sylvania .com Fax (717) 268-5178 Towand a, PA 18848-0504

LE:AR REGULATORY O ::,

U EMAKINGS & ADJUDlCATIO S STAFF OFFICE OF THE SECRETARY OF THE COMMISSIO P stmark Data _

C HOOl;!l\iOO -

x~~v?

D -) I '5

__ _ _ _ _ ____J

The USNRC recognized these circumstances and provided the following guidance to thorium licensees (see Information Notice 96-18, "Compliance with 10 CFR Part 20 for Airborne Thorium"):

"Although bioassay techniques are still useful in assessing relatively large intakes, they are not capable of providing routine monitoring for intakes substantially below the ALI. The air monitoring program therefore usually must assume a much greater importance at facilities using unsealed thorium than for other radionuclides. Facilities using thorium need to rely on accurate air sampling to estimate intakes that cannot be detected by bioassay techniques, which, in effect, includes all intakes other than those that approach or exceed the ALI."

Because of the difficulties of implementing a conventional bioassay program at facilities using thorium dioxide, and because air monitoring cannot be used to confirm the level of protection afforded by the respirator, it is clear that the bioassays required in proposed 10 CFR 20.1703(c)(2) would be unnecessary.

A related example is cases where respirators are used, but no "credit" for the protection factor afforded is taken in the assignment of the dose of record. The USNRC makes it clear in the preamble to the proposed rule that the requirements of 20.1703 are activated whenever a respiratory protection device is used to limit the intake of a radioactive material whether or not credit is taken for the device in estimating doses.

At Sylvania, and presumably other workplaces, work can take place in areas where we have determined that there is no requirement for either respiratory protection or individual monitoring of internal exposures, but where respiratory protection devices are made available to employees to use if they so chose. Under these circumstances, we would again assume that the confirmatory bioassays called out in proposed 10 CFR 20.1703(c)(2) are unnecessary.

It would be helpful to Sylvania and other licensees if, when the proposed rule is issued, a statement is made clarifying the intent of the wording change in 10 CFR 20.1703(c)(2) from "as appropriate" to "as necessary", particularly for those cases when conventional bioassay for thorium licensees would not provide data useful for confirming the effectiveness of a respiratory protection program, and when no "credit" is taken for respirator use in the dose assessment process. To add additional emphasis, the USNRC may wish to consider the following modification (shown in italics) to 10 CFR 20.1703(c)(2) be made:

"If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material, the licensee shall implement and maintain a respiratory protection program that includes surveys and bioassays, if necessary and if protection factors are used for dose assessment, to evaluate actual intakes."

If you have any questions or if we can provide additional information on this matter, please contact me at (717) 268-5128.

Sincerely, ~

~~,

• Carmen Venezia, CIH Radiation Safety Officer cc: A. M. Alper, Ph.D.

J. Bonnell, CIH J. Delehant, Esq.

C. D. Berger, C.H.P.

3

3M Occupational Health and JM Center. Building 260-38-09 Environmental Safety Division St. Paul. '.'v!N 5.'il-+-+-1000 DOCKETED USNRC

'98 SEP 22 P5 :OQ 3IVI September 21, 1998 OFt i( f RULt. .! .J ADJUD11 ,, 1,4':*F Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff

Reference:

NRC Proposed Amendment of 10 CFR part 20

Dear Sir or Madam:

Minnesota Mining and Manufacturing Company (3M) through its Occupational Health and Environmental Safety (OH&ES) Division is a major manufacturer and supplier of respiratory protective devices throughout the world. 3M has invented, developed, manufactured and sold approved respirators since 1972. We have developed numerous training programs, videos, computer programs and technical literature to help our customers develop and run effective respirator programs. Our sales people have trained and fit tested hundreds of thousands of respirator wearers throughout the world. Our technical staff has performed basic research on the performance of respirators and their use, presented and published these data in numerous forums and participated in the development of the ANSI Z88 standards on respiratory protection. We have substantial experience in respiratory protection and all phases of its use.

We are pleased to provide the Nuclear Regulatory Commission with our comments on the proposed revision of the standard for respiratory protection that was published in the Federal Register, 63 FR 38511, dated July 1t\

1998. Specific comments are attached that answer the questions asked by the commission.

In summary, the NRC proposed rule closely follows the advice in the ANSI Z88.2 (1992) standard. This standard represents the best advice on how to implement a respirator program. In general we support the proposed rule, except in specific areas where NRC has chosen to depart from the ANSI standard. Most of our comments will deal with Appendix A - Assigned Protection Factor Table.

SE? 2 S ,998 Acknowledged by card .. ... ,.........- -

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• I I

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Nuclear Regulatory Commission Page2 September 21, 1998 We believe that NRC needs to consider how the proposed rule will relate to the newly revised OSHA standard on respiratory protection, 29 CFR 1910.134 issued January 8, 1998, and the ANSI Z88.2 standard. In some cases, employers will be regulated by both NRC and OSHA If there are variations in the program required by NRC, it will make it difficult to comply with both standards often requiring duplication of effort.

Enclosed are two peer reviewed journal articles by T. J. Nelson and one by W. R. Myers that are referenced in our comments to substantiate our positions. Also enclosed is a letter from 3M to A Rocklein dated June 3, 1997 and a letter from 3M to Dr. D. Cool dated September 8, 1997. These

. letters detail the 3M position on the standard and are being submitted at this time so that they are a part of the permanent docket record.

We appreciate the opportunity to add our comments and knowledge to the rulemaking record and look forward to a fair, protective and useful standard.

Sincerely, Ronald E. King Regulatory Affairs Manager 3M Occupational Health and Environmental Safety Division Attachments

3M Comments on specific areas of the NRC Proposal Appendix A - Assigned Protection Factor Table NRC has generally adopted the assigned protection factors from the ANSI standard, except for "single use - disposable" and half and full facepiece demand type respirators. For "single use - disposable" type, no APF is listed, however if an employer demonstrates though fit testing that a fit factor of 100 is achieved, then the APF of ten can be assumed (Footnote e). NRC should delete the use of the term "single use - disposable". There is no longer a single use approval category in NIOSH 42 CFR part 84. NRC is defining half mask elastomeric respirators as those with a plastic or elastomeric sealing surface and having 2 or more adjustable suspension straps.

NRC is using the ANSI APFs since they represent "state-of-the-art" guidance and reflect consensus of the technical community. However, in the case of the "single use - disposable", NRC is basing the decision to use alternative APFs on "beliefs" or reasoning other than an examination of available technical data and literature. We believe that this is inconsistent with the intent and goals of the NRC standard and that NRC should follow the ANSI APF guide in total. NRC did not reference any technical information to disagree with the ANSI standard.

Rather than relying on beliefs, NRC should rely on performance data. In determining Assigned Protection Factors, the ANSI committee used the best 1

technical data available so it would be reasonable for NRC to adopt these without making certain exceptions based on opinion.

Workplace data suggest that the APF of ten is appropriate for all half facepiece respirators. There are no data that suggest that a filtering facepiece respirator, without an elastomeric seal and adjustable straps, performs any less well than 2

the elastomeric type. Nelson has shown, in an analysis of WPF studies , that no statistical difference was found between filtering facepiece and elastomeric respirators.

This is not an unexpected result if the performance of the two styles of half facepiece respirator is examined. Performance is determined by leakage*into the respirator. Leakage can occur through pathways; filter, faceseal or defect.

Filter leakage, or penetration, is controlled by the certification process. The 1

Nelson, T.J., The Assigned Protection Factor According to ANSI, Am. Ind. Hyg. Assoc. J.

57(8)735-740 (1996) 2 Nelson T. J.: The Assigned Protection Factor of Ten for Half Mask Respirators, Am. Ind. Hyg.

Assoc. J. 56(7) 717-724 (1995) 3

certification tests allow the same penetration, or require the same efficiency, for filtering facepieces as for the same class of filter used on an elastomeric facepiece. The same fit tests are used for either type of respirator to limit faceseal leakage to 1% or less. If the respirator is properly maintained and inspected rio difference in performance is expected and the referenced studies 2 show similar performance.

The Appendix is confusing in that an employer can choose to use an acceptable fit test and use the APF of ten for the filtering facepiece type of respirator. Is this acceptable fit testing not a requirement for all tight fitting facepiece respirators used for protection? If it is, then no distinction should be made in the APF of the half facepiece devices. As written, Appendix A seems to say that an elastomeric can be used with no fit testing nor medical evaluation, and still use an APF of 10.

The better solution would be for the Appendix A Table to assign an APF of 1O to all half facepiece respirators. All requirements of a good respirator program should be required, including valid qualitative or quantitative fit testing. NRG could then choose to allow the use of respirators (any kind) in "voluntary use" situations or areas where respiratory protection is not required with some relaxed requirements. Program elements such as training, medical evaluation, maintenance, inspection and storage are necessary in these situations to prevent the use of the respirator from causing "harm" to the employee. Other provisions, such as fit testing, would not be required.

This would be more in line with the recent OSHA standard, and, in reality, is what the NRG proposal is saying by way of the footnotes.

Additional Comments on the Assigned Protection Factor Table The table is not written in plain English, as regulations are now supposed to be.

Terminology used in the ANSI standard should be followed, e.g., half mask, full facepiece, etc. The table should be clarified within its body so that it does not require so many explanatory footnotes.

Delete 'Particulate' and 'Gases and vapors' column headings. Replace with one column called 'Assigned Protection Factor (APF)'. Current format is more confusing than helpful. This method implies that a gas and vapor respirator with a particulate filter does not have one APF. 20.1703 (c)(1) requires proper equipment selection. This implies that the person selecting respirators knows that a filter is for particulate hazards and not for gases and vapors.

4

Footnote a In footnote a, it is incorrect to reference 29 CFR 1910 only. Other OSHA regulations such as 1926 may apply. We suggest simply stating that Department of Labor regulations apply.

Footnote b In footnote b, delete the 'Modes' column. Incorporate the words demand, pressure demand, and continuous flow into the plain English respirator descriptions in the body of the table, e.g., Full facepiece, pressure demand or continuous flow. Remove terms such as NP and PP, since the proposal doesn't

_define what the terms mean. For example, listing 'Powered Air Purifying

• Respirator' is clearer than 'PP'. NIOSH does not consider these positive pressure devices.

Footnote c Footnote c should be deleted. The specification of filter efficiency should be addressed in the text of the standard or the APF table, not as an obscure footnote.

Footnote c also appears to contain an error. It states that for respirators with APFs less than 100, filters that are at least 99.97% efficient arer required.

We believe that it is supposed to say APFs greater than 100.

In addition, for respirators with APFs less than 100, NRC proposes to require that filters be at least 99% efficient. No explanation is given for proposed requirements of 99 percent efficient filters for half masks and 99.97 percent efficient filters for full facepieces. These requirements do not appear to take into account the differences between NIOSH certification testing and real world filter performance. NRC did not identify any data indicating that a 95% filter is not sufficient.

NIOSH certifies filters in three levels of efficiency (95, 99 and 99.97%). A filter must remain above the required efficiency for the duration of the test. The tests are performed at extreme conditions that are not representative of the workplace. For example, airflow through the filter is set at 85 1pm, equivalent to a person performing at a very high work rate. The challenge aerosol is at or near the most penetrating particle size. Because these extreme conditions are not found in the workplace, filter efficiency will be essentially 100 percent for any certified filter.

5

Selecting a filter with a higher filter efficiency does not always have the desired result of better protection. A 99% efficient filter may not be better than a 95%

efficient filter. Higher filter efficiency leads to higher pressure drop across the filter. This results in increased breathing resistance that effects comfort so that the respirator may not be worn for the time required or worn properly. In addition, the increased discomfort may affect the ability to sustain work effort and could result in the job taking longer. Increasing the time to do the work directly contradicts TEDE ALARA that NRC states as their position. Thus, not using 95% filters contradicts the NRC position. Also, laboratory experiments have shown that as pressure drop increases, leakage through the faceseal increases., Therefore, requiring a higher filter efficiency may lessen the amount of protection that can be achieved due to increases in faceseal leakage.

Footnoted In footnote d, the first sentence should be modified for clarity as follows: 'The assigned protection factors are not applicable to radioactive contaminants that present an absorption or submersion hazard.' Delete last sentence. This provision should be covered in the text of the standard, not as a footnote to the APF table. The text should identify criteria to determine when use of a cartridge may be considered, i. e., demonstrated efficiency against the gas or vapor, ability to establish change schedule, etc.

Footnote e Footnote e should be deleted. The first sentence is true of any tight fitting respirator. Footnote a states that APFs only apply to properly fitted devices.

The footnote states that it is difficult to perform a positive or negative pressure pre-use fit check on filtering facepiece type respirators. Again, this is a "belief',

or opinion, that is unfounded in scientific reality and is improper in a regulatory standard. NRC did not reference any technical information to support its position. NRC would be better served by relying on technical information.

For this type of respirator, the fit check process is different. Rather than determining if pressure can be maintained inside the facepiece, a check is made whether the flow of air can be detected around the faceseal. These checks have been shown to be an effective method of checking respirator fit and perform as well as the traditional fit checks on elastomeric type facepieces. 3 "Fit check methods applied to the OFF (Disposable Filtering Facepiece) respirators were found to be equivalent to the fit check methods applied to the 3

Myers, W.R, M. Jaraiedi, and L. Hendricks: Effectiveness of Fit Check Methods on Half Mask Respirators. Appl. Occup. Environ. Hyg. 10(11):934-942 (1995).

6

EF (Elastomeric Facepiece) respirator by all criteria used in the study to assess fit checks. The sensitivity of the fit check to detect bad donnings of previously fit tested respirators averaged 96% for all four respirators. Conversely, the percent of subjects accurately identifying properly donned respirators with the fit check averaged 66% for all four respirators. Considering that fit check methods are very simple to perform and require no ancillary equipment, the sensitivity and specificity for these methods are remarkably good."

As discussed earlier, the fifth sentence should apply to any half mask respirator and is therefore redundant.

Footnote f Footnote f should also be deleted based on the previous discussion of the performance of half mask respirators. No data exist that show elastomeric facepiece respirators, or respirators with a seal-enhancing material, perform better than those without. In addition, the ANSI committee could find no data to justify limiting the APF of the quarter mask. The required fit testing will detect the same level of faceseal leakage for either quarter mask or half mask respirators, and eliminate ill fitting respirators of either type. Therefore, there is no apparent reason to distinguish between the two. This reasoning is used in the ANSI standard. If NRC has data to prove that this type of respirator should not be used, it would be more appropriate to change the certification system and not allow the quarter mask type to be approved rather than trying to discourage their use through artificial means.

Footnote i The last sentence of footnote i should be deleted. This is covered by the respirator program (fit testing, maintenance or training).

Comments on specific sections of 10 CFR 20 Proposal I

§20.1003 Definitions Fit Check (User seal check): NRC should eliminate the reference to irritant smoke check and isoamyl acetate check. This will create confusion as these are qualitative fit test materials. Users will then assume that the positive and negative pressure tests are qualitative fit tests, which they are not. We suggest following ANSI or OSHA for definitions and procedures.

7

NRC has added several definitions to the standard to clarify the regulation. We believe that several other ANSI standard definitions would add additional clarity to the NRC standard. Our suggestions for additional definitions are listed below:

Filtering Facepiece Respirator: A type of disposable respirator in which the filter is an integral part of the facepiece or with the entire facepiece composed of filter medium.

Hood: A respiratory inlet covering that completely covers the head and neck and may cover portions of the shoulders.

Loose-fitting facepiece: A respiratory inlet covering that is designed to form a partial seal with the face, does not cover the neck and shoulders, and may or may not offer head protection against impact and penetration. (Note - This is a new term in Regulations being introduced by the NRC and needs to be defined.)

Qualitative fit test: A pass/fail fittest that relies on the subject's sensory response to detect the challenge agent.

Quantitative fit test: An assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

Respiratory inlet covering: That portion of a respirator that connects the wearer's respiratory tract to an air-purifying device or respirable gas source, or both. It may be a facepiece, helmet, hood, suit, or mouthpiece/nose clamp.

Suit: A respiratory inlet covering designed to cover the entire body. This term does not include protective clothing that only provides skin protection.

Tight-fitting facepiece: A respiratory inlet covering that is designed to form a complete seal with the face. A half-facepiece (includes quarter masks, disposable masks, filtering facepiece respirators and masks with elastomeric facepieces) cov-ers the nose and mouth; a full facepiece covers the nose, mouth, and eyes.

§20.1703 (c)(6) Fit Testing NRC is proposing to require fit testing for all tight fitting respirators.

Requirements include fitting negative pressure respirators to a fit factor of 10 times the APF and positive pressure devices to a fit factor greater than 100.

Periodic refitting is required on a 3 year interval.

We believe that it would be useful for NRC to provide a reference in this section to fit test procedures. We recommend the procedures in OHSA 29 CFR 8

1910.134 issued 1/8/98. This provides consistent and uniform requirements for locations that are regulated by both NRC and OSHA The three year interval between tests in the proposed rule differs from* the requirements in the OSHA and ANSI standards, each requiring an annual fit test.

NRC commented that the agency believes that an employer can be alert to changes in physiology that would effect the outcome of a fit test. We know of no information that supports that belief for negative pressure respirators.

In the preamble to the final rule, OSHA summarized the information from the record. OSHA noted that data in the record supported their position to fit test negative pressure respirators on an annual basis.

"Annual retesting of respirator fit detects those respirator users whose respirators no longer fit them properly. The Lord Corporation, which already performs annual fit tests, reported that of its 154 employees who wear respirators, one to three (2 percent or less) are identified each year as needing changes in model or size of mask (Ex.54-156). Hoffman-LaRoche only performs fit tests at two-year intervals, and it reported a much higher incidence of fit test failures. Sixteen of the 233 people tested in a recent two year cycle of fit testing (6.86%) needed a change in their assigned respirators (Ex.54-106). The Lord experience (Ex.54-156) indicates that annual retesting of facepiece fit detects poorly fitting facepieces, while the Hoffman-Lc;1Roche evidence demonstr~tes that waiting two years for retesting can result in the discovery that quite a high percentage of workers have been relying on poorly fitting respirators.

Extending the retest interval to more than one year would allow those individuals with poor fits that could have been detected by annual fit testing to wear their respirator for a second year before the poor fit is detected."

We therefore recommend an annual fit testing requirement for all tight fitting respirators. This would also be consistent with the current OSHA standard.

§20.1703 (g)

Paragraph (g) requires the use of Grade D air for air supplied respirators as defined in the ANSI-CGA G-7.1 (1989) standard. This standard has recently been revised, the current date is 1997.

9

Effectiveness of Fit Check Methods on Half Mask Respirators Warren R. Myers, A Majid Jaraiedi,A and Lynnette Hendricks13 ACollege of Engineering, West Virginia University, Morgantown, West Virginia 26506; 6 Nuclear Energy Institute, Washington, DC pressure sealing test. Historical referencing of negative and Studies we_re conducted to evaluate whether a positive/negative positive sealing test procedures in American Industrial Hygiene

(+I - ) fit check was an effective aid in helping users of respiratory Association/American Conference of Governmental Industrial protective equipment (RPE) achieve a good fit when donning the Hygienists and American National Standards Institute (ANSI)

RPE. Two types ofhalf-facepiece RPE were used in the studies: the recommendations and standards is traced in Table 1.

disposable, filtering facepiece and the elastomeric facepiece. Three After a worker has been fit tested and assigned a respirator, models of disposable, filtering facepiece and one model of dual-car- the U.S. Occupational Safety and Health Administration's tridge, elastomeric facepiece were evaluated. A population of 64 in- (OSHA) RPE standard 29 CFR 1910.134(e)(5)(i) states, erienced users of RPE was randomly divided into two equal " ... To assure proper protection, the facepiece fit shall be oups. One group was trained to don the RPE using the + /- fit checked by the wearer each time he puts on the respirator.

This may be done by following the manufacturer's facepiece check as an aid, while the second group was trained to don the RPE fitting instructions. "(4) without conducting a + / - fit check. The number of successful RPE The 1992 American National Standard for Respirator Pro-donnings achieved in the group using the fit check was compared tection defines a fit check as a test conducted by the wearer to with the number of successful RPE donnings achieved in the group determine if the respirator is properly seated to the face and is not using a fit check. The data obtained from this experiment sug- performed by appropriate means each time the respirator is gested that, in general, fewer unsuccessful donnings and more con- donned or adjusted, "appropriate means" being the procedures sistent donnings were obtained by RPE users when fit checks were recommended by the manufacturer or by checks described in used as an aid in donning both general types ofRPE used in the study. the standard. <3 )

This implies that a + / - fit check has value in assisting the wearer of Based on cun-ent practice and terminology, a fit test is a disposable filtering facepiece or a half mask to properly don the conducted to assess the fit of the RPE during the initial selection process or during follow-up fit tests typically con-RPE. On a second population of 64 inexperienced users ofRPE, the ducted at 6-montl1 or yearly intervals. In contrast to a fit test, pass/fail outcome of fit checks was used to measure the discrimina-a fit check is a simpler procedure that does not require addi-tory power of fit checks. The subjects used the + /- fit check to tional equipment. The fit check is for the user of an already

• scrirninate whether the fit ofRPE preadjusted by the experimenters properly fit RPE to use with each donning to ascertain or s good or bad. Fit checks were found to be fairly useful, easy-to- check that the RPE is properly set on the face. The appropriate earn tools for respirator wearers to discriminate between good and understanding of a fit check is that it is an adjunct to the formal poor donnings. MYERS, W.R.; JARAJEDI, M.; HENDRICKS, L: EFFECTIVENESS OF Frr process of fit testing, a tool to aid with each donning of the CHECK METHODS ON HALF MASK RESPIRATORS. APPL. OccuP. ENVIRON. HYG. RPE.

10(11 ):934-942; 1995. While the ANSI standards mention several fit check proce-dures, the authors are aware of only the positive and/ or negative pressure fit check procedures being commonly used or recommended by manufacturers of RPE. In general, the urrent regulations, standards, and recommendations ad- end point of these tests is to be able to maintain a + / -

C dressing use and selection of respiratory protective equip- pressure within the facepiece for a few seconds or to be able to ment (RPE) require that individual users be fit tested as part of detect face seal leakage associated with an increased + /-

the selection process and also that they be able to conduct fit pressure.

checks when donning the RPE_(l-S) To check for maintenance of negative pressure, the user The 1980 American National Standard for Respirator Pro- typically blocks off the air inlet(s), inhales sharply so that the tection recommends that each RPE wearer undergo and pass a mask collapses slightly, briefly holds the inhalation, and deter-quantitative or qualitative fit test as part of the selection process mines if a negative pressure is maintained inside the RPE for a and be required to check the seal of the respirator by appro- few seconds and/or there is no detection of in-board air priate means prior to entering a harmful atmosphere. (l) The coming in the face seal. The positive pressure sealing test is standard states that to check the seal the wearer should use pe1formed similarly. The wearer blocks off the air outlet, procedures recommended by the respirator's manufacturer or exhales slightly to cause the RPE to inflate, briefly holds the by any of several field tests which are subsequently described. exhalation, and then determines if a positive pressure is main-Among the field tests listed was a negative and/ or positive tained inside the RPE for a few seconds and/ or there is no 934 APPL.OCCUP.ENVIRON.HYG. 10(11)

• NOVEMBER 1995

• 1047-322X/95/1011-934$9.50/9 © 1995 AIH

• SSDI 1047-322X(95)00207-J

APPL.OCCUP. ENVIRON.HYG. Effectiveness of Fit Check Methods 935 10(11) NOVEMBER 1995 TABLE 1. Evolution of Negative and Positive Pressure Test Traced Through Selected Documents Reference Negative Pressure Test Positive Pressure Test AIHA/ ACGIH 1963<5 l Close off the inlet opening of the canister by covering Close off the exhalation valve and exhale it with the palm of hand or by replacing the tape seal, gently so that a slight positive pressure is inhale so that the facepiece collapses slightly, and hold built up in the facepiece. If no outward the breath for 10 seconds. If the facepiece remains in leakage of air is detected at the periphery its slightly collapsed condition and no inward leakage of the facepiece, the face fit is of air is detected, the tightness of the gas mask, as satisfactory.

worn, is satisfactory.

ANSI Z88.2-1969<6 l Close off the inlet opening of the canister or Close off the exhalation valve and exhale cartridge(s) by covering it with the palm of the gently into the facepiece. The face fit is hand(s) or by replacing the seal(s), inhale gently so considered satisfactory if a slight positive that the facepiece collapses slightly, and hold the pressure can be built up inside the breath for 10 seconds. If the facepiece remains in its facepiece without any evidence of slightly collapsed condition and no inward leakage of leakage of air at the seal. For most air is detected, the tightness of the respirator is respirators, this method of leak testing probably satisfactory. requires that the wearer first remove the exhalation valve cover and then careful!

replace it after the test.

ANSI Z88.2-19S0<1 l Follow procedures recommended by the manufacturer Follow procedures recommended by the or the inlet opening of the respirator's canister(s), or manufacturer or the exhalation valve, or cartridge(s), or filter(s) is closed off by covering with breathing tube, or both, is closed off and the palms of the hand(s), by replacing the inlet seal on then the wearer exhales gently. The fit a canister(s), or by squeezing a breathing tube or of a respirator equipped with a facepiece blocking its inlet so it will not allow the passage of is considered to be satisfactory if a slight air. Then the wearer inhales and holds his or her positive pressure is built up inside the breath for at least 10 seconds. If a facepiece collapses facepiece without the detection of any slightly and no inward leakage of air into the outward leakage of air between the facepiece is detected, it can be reasonably assumed sealing surface of the facepiece and the that the fit of the respirator to the wearer is respirator wearer's face. The fit of a satisfactory. For a respirator equipped with a respirator equipped with a mouthpiece mouthpiece and nose clamp, if leakage of air into the and nose clamp is considered satisfactory.

nose or mouth cannot be detected, then it can be if the respirator wearer senses a buildup reasonably assumed that the fit of the respirator to the of positive pressure and is unable to wearer is satisfactory. detect any outward leakage of air through the nose and in the area between the mouth and mouthpiece.

ANSI Z88.2-1992<2l Follow procedures recommended by the manufacturer Follow procedures recommended by the This standard carries the following or the inlet opening of the respirator's canister(s), or manufacturer or the exhalation valve, or caution: "Care must be taken in cartridge(s), or filter(s) is closed off by covering with breathing tube, or both, is closed off and conducting negative or positive the palms of the .hand(s), by replacing the inlet seal on then the wearer exhales gently. The fit pressure fit checks. Thorough a canister(s), or by squeezing a breathing tube or of a respirator equipped with a facepiece training in carrying out these tests blocking its inlet so it will not allow the passage of is considered to be satisfactory if a slight should be given to respirator air. Then the wearer inhales gently and holds his/her positive pressure is built up inside the

- wearers. Fit checks are not breath. If a facepiece collapses slightly and no inward facepiece without the detection of any substitutes for qualitative or leakage of air into the facepiece is detected, it can be outward leakage of air between the quantitative fit tests." reasonably assumed that the fit of the respirator to the sealing surface of the facepiece and the wearer is satisfactory. respirator wearer's face.

detection of outbound air exiting the face seal. These fit checks al. (7) did report on a study correlating results of a negative were described in early standards and recommendations as pressure qualitative fit test against fit factors obtained by stan-documented in Table 1. dard quantitative fit test. They reported that out of 195 passing Manufacturers of disposable, filtering facepiece RPE typi- negative pressure qualitative fit tests, only one was found to cally recommend covering the mask with both hands, exhal- provide a quantitative fit factor of less than ten.

ing, and checking for air flow between the face and the sealing The objective of this article is to address a* number of surface of the respirator. questions and issues regarding fit checks: (1) Does performing

-While these fit check methods are widely recommended a fit check help users of properly fit RPE detect bad donnings?

and used, there is no published research that has evaluated the (2) Does use of a fit check increase the probability of achieving efficacy of fit checks in aiding wearers to don RPE. Hardis et a certain level of fit? (3) Does use of a fit check provide more

936 W.R. Myers et al. APPL.OCCUP. ENVIRON.HYG.

10(11) NOVEMBER 1995 consistent donnings of the RPE? (4) Is the fit check recom- facepiece (DFF) respirators. The fourth type was a dual-car-mended for filtering facepiece respirators as effective as those tridge, elastoni.eric facepiece (EF) respirator.

recommended for elastomeric respirators? One of the three DFF respirators was a NIOSH-certified This article reports the results of two experiments. The first dust/mist (D /M) class device that incorporated a moldable evaluated the usefulness of the fit check to assist subjects in nose clip. The second was a NIOSH-certified dust/fume/mist correctly donning RPE by comparing the number of successful (D/F/M) class device that had an exhalation valve and a donnings achieved in two groups: one donning with the aid of moldable nose clip. The third was a NIOSH-certified, high a fit check, and the other without the aid of a fit check. The efficiency (HE) class device that had an exhalation valve, a second experiment measured the discriminatory power of a fit moldable nose clip, and an elastomeric face seal ring. The DFF check by having subjects assess the fit ofRPE which had been respirators were available in only one facepiece size except for preadjusted to cause poor fit characteristics. the HE, which was available in two sizes.

The EF respirator was configured with NIOSH-certified DIM class filter elements. This respirator was available in two Materials and Methods facepiece sizes.

Test Subiects Subjects were recrnited via questionnaire from a very large Respirator Pread;ustment for Experiment II population (>10,000) of predominantly white-collar workers. The moldable nosepiece on the three DFF respirators provided

~AJl subjects had to meet the following minimum requirements an opportunity to preadjust the nosepiece to purposely induce

, . o participate in the research study: 1. no direct affiliation or leaks around subject's nose. Oestenstad et al. (JO) found that the I business responsibility with the research, design, or manufac- nose is the most common leak site for subjects wearing half-

, ture ofRPE; 2. no previous training in the use ofRPE; 3. no facepiece respirators. In that study, which involved 73 subjects, previous experience with wearing RPE in their jobs; and 4. no the nose was involved as a site of leakage approximately 78 facial hair that would compromise the seal of the RPE. percent of the time.

Potential test subjects, meeting the aforementioned criteria, The nosepieces of the DFF respirators were prefom1ed on were given manufacturer's instructions for donning the RPE. one of two different head fom1S. One head fonn had a ve1y They were then fit tested using the sodium saccharin qualita- wide, smooth nose bridge which left the nosepiece virtually tive fit test method following the protocol published in the unchanged from its out of-the-package configuration. The OSHA Lead Standard 29 CFR 1910.1025.<8) This method has other had a much narrower nose, which resulted in the nose-been validated against quantitative fit test methods to be ca- piece being squeezed together during the preforming. These pable of rejecting masks with fit factors of less than approxi- two preformed nosepiece configurations, coupled with the mately 100. <9) range of facial sizes and nose shapes represented by the study If the subject failed the initial fit test, the respirator was population, presented the possibility for a wide range of fit donned again and the fit test was repeated. If the subject failed outcomes.

the fit test on the second donning, that respirator was not used Preadjustments on the EF respirator consisted of setting the y that subject in the study. Subjects failing to receive adequate head and neck straps 2 cm looser than where the subject had t on more than one of the four respirators were not selected initially adjusted the straps to pass the saccharin qualitative fit for the study. test. Strap length had been noted during the training session.

Subjects were randomly divided into three groups. The 32 The head cradle constrnction of this respirator made it possible stibjects assigned to group 1 were trained to don and adjust the to preadjust strap tension for this phase of the testing while still respirators but were not instructed on using fit checks. The 32 enabling the subjects to easily don the respirator. In addition, subjects assigned to group 2 were trained to don and adjust the each subject wore both sizes of the EF respirator, resulting in respirators with the aid of fit checks. Because of the fit test an even greater range of fits.

inclusion criteria discussed in the preceding paragraphs, in some cases there were less than 32 subjects wearing each of the Laboratory Protection Factor Testing four respirators in these two groups.

• The quality of each donning was assessed from measurements The 64 subjects assigned to group 3 were trained to don and of particle concentrations inside and outside the respirator adjust the respirators with the aid of fit checks. This group was during a chamber test. It is important to note that since used in experiment II to measure the discriminatory power of non-high efficiency particulate air class filters were used (in a fit check by having subjects assess the fit of the RPE which contrast to requirements to conduct fit testing), filter penetra-had been preadjusted to purposely cause poor fit characteristics.

tion could be a significant contributor to the in-facepiece Subjects selected for use in the studies received a small concentration. Therefore, the independent variable of the compensation for their participation.

chamber test is denoted as a laborato1y protection factor (LPF). (t l) As defined for the purposes of this study, the LPF is Respirators the ratio of chamber particle concentration to in-facepiece Four negative-pressure, half-facepiece respirators were used in particle concentration, where the in-facepiece concentration is the study. Each is certified in the United States by the National a function of filter efficiency as well as face seal penetration.

Institute for Occupational Safety and Health (NIOSH). The Chamber testing was pe1fonned with a system that utilized assigned protection factor for half-facepiece respirators is ten. (Z) a TSI model 3450 vibrating orifice aerosol generator to pro-Three of the RPE were different types of disposable filtering duce a 2.0-µ,m diameter particle of com oil. Particles were

APPL.OCCUP.ENVIRON.HYG. Effectiveness of Fit Check Methods 937 10(11) NOVEMBER 1995 counted with a TSI model 33 APS unit. The equipment and TABLE 2. Aerosol Penetration Through Filters and Valves test setup have been previously described in greater detail. (lZ) Mean Percent Standard Filter Elf.

In-facepiece particle counts were determined at 1-second Respirator Penetration N Deviation Factor*

intervals and averaged over each exercise period, which lasted for 0.5 minutes. The exercises used were the standard six DIM DFF 1.25 6 0.153 80 exercises suggested for quantitative fit testing of half-facepiece D/F/M DFF 4.50 X 10- 3 8 0.0019 22,000 respirators. (l) HEDFF 3.90 X 10- 4 6 0.00021 256,000 Chamber concentration was detemlined by averaging the D/MEF 5.48 X 10- 3 5 0.00134 18,200 particle counts from 1-minute sampling periods immediately *A number inversely related to the penetration of the filter. (l 7) before and after the subject perfo1med the six exercises.

Penetration for a particular exercise (P) was calculated from the average of the 30 1-second in-facepiece particle counts facepiece. The magnitude of the filter and exhalation valve (FPC) made during that particular exercise and the average leakage on these respirators was estimated before testing began.

chamber particle counts (CPC). To evaluate filter efficiency, specimens of each respirator were sealed with an air-tight seal to a test form. Air was drawn through the respirator with a breathing machine operated with (1) a 622 work rate cam which produced a tidal volume of 1.6 L.

The stroke frequency was adjusted to produce a nlinute flow The average test penetration. was calculated as follows: rate of approximately 30 L. The challenge aerosol was the cor oil aerosol used in pe1fo1ming the LPF testing. Table 2 show the results of the filter penetration studies that were pe1f01med.

The filter penetrations of the DIFIM and HE filtering facepieces and the DIM EF were very small. On these devices P,esc (2) filter penetration would not be a major source of in-board leakage. On the DIM filtering facepiece the filter penetration where: was 1.25 percent. For this device, filter penetration could be a j = 1st to the nth exercise. significant contributor to total in-board leakage and thereby confound evaluation of the fit check.

The overall test LPF was calculated as the inverse of the overall test penetration. Experimental Protocols EXPERIMENT r. In experiment I, which was to evaluate fit 1 checks as an aid to successful donning, two groups of 32 LPF,esc = p (3) subjects with no previous experience wearing respirators were test trained to don the four respirators following the manufacturer's Measurements of in-facepiece particle counts were cor- instructions.

rected for errors introduced by retention of particles in the One group was trained to use fit checks as part of th lung. Models for deposition of inhaled aerosols for nose and donning process. The fit check outcome (i.e., pass or fail) wa mouth breathing were used to derive the fraction of particles noted. Again, the manufacturer's instructions for conducting deposited in the lung. (13) It was assumed that subjects spent the fit checks were followed. With the EF respirator the fit equal time nose and mouth breathing. The particle diameter of check instructions were to use either a positive pressure or a the test aerosol was -2.0 µ,m, with a particle density of0.91. negative pressure sealing test; therefore, one-half of the 32 Based on breathing patterns characteristic of sedentary work subjects were Jandomly selected and trained on one fit check rate conditions, an average flow rate of 500 ml/s was selected or the other.

along with an average residence time of 2 seconds_(1 4 -15l The second group only received donning instructions (e.g.,

Under these conditions, the models yield deposition frac- how to position the mask on the face, how to adjust the straps, tions of -0.48 and -0.81 for mouth and nose breathing, and how to mold the nosepiece to the nose, etc.). They respectively. Averaging these values, assunling equal time is received no training or instruction in conducting or using fit spent nose and mouth breathing, leads to an average deposition checks.

fraction of -0.65. Subjects were trained over a 2-day period. Two of the four When calculating the correction factor to apply to the respirators were randomly selected for each day. Testing was overall breathing cycle, it was assumed that inhalation and conducted over the 3 days immediately following their train-exhalation times were equal. The deposition fraction was only mg.

applied to the exhalation portion of the breathing cycle. The Six replicate donnings and associated LPF measurements resulting correction factor was 0.675.(1 6) The correction factor were made on each test subject for the respirators in which was used as a constant that was applied to each test result. they had been successfully fit tested. The respirator test order Correcting in-facepiece particle count data for lung deposition was randonlized. There is a subjective factor in how a person increases estimates of penetration. dons a respirator and perfonns a fit check. This subjectivity The in-facepiece particle count data reflected total in-board would tend to make the six donnings per subject not inde-leakage, that is, leakage through the filter and exhalation valve pendent. For statistical analyses, sample sizes were corrected of the facepiece, as well as around the sealing surface of the using the Satterthwaite method. (l 7) This method uses the es-

938 W.R. Myers et al. APPL.OCCUP.ENVIRON.HYG.

10(11) NOVEMBER 1995

~.00 with fit checks. The fit check and no fit check groups were compared in several ways. First, log probability plots compar-00.~ 1- !Fot Cl'il~©lk~;

I

-~ ~- --=--

U"'ili\J/ IFU~ ~U ""'""""""* IU u rr, = ~2 g;IQ)

I I ing the LPFs measured on each group were made for each 00 respirator (Figures 1 through 4).

T f Figure 1 is the log probability (L-P) plot of the LPFs for the

~5 ib/ groups donning the DIM filtering facepiece with and without 00 the aid of fit checks. Each plotting point is the geometric mean 81[)) V

~ j[ (GM) LPF for each subject. The L-P distributions of the LPF I

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~  :, values measured on subjects using and not using fit checks are 00 n ~

very similar between the 30th and 80th percentiles. The GM

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..,7 p LPF for the no fit check group was 93, while the group using r 1 fit checks had a GM LPF of 110. No significant difference in

"'U(O) y GM LPF was found between the two test groups.

5 l There is evidence in Figure 1 to suggest that using fit checks 1 did improve the LPF values at the low end of the distribution (below the 30th percentile). The use of the fit check had the

((U effect of shifting the low end taii of the LPF distribution to the right. These observations suggest that conducting the fit check 1(0[)) 1!00)0 had some value in helping to improve or eliminate poorer-l~b©rSlt©fi)!' IP'r©t@eto©l'l IFSltt©r quality donnings. The variability in LPF measurements was not found to be significantly lower in the test group donning with FIGURE 1. Distributions of LPFs obtained on two groups of subjects the aid of fit checks (Table 3).

donning a D/M DFF with and without using fit checks. Figure 2 shows the L-P plot of the LPFs for the D/F/M filtering facepiece. The distribution LPF values obtained on the test group donning with fit checks fell to the right of the timates of intersubject and intrasubject variability to determine group not using fit checks, that is, the group using fit checks a modified sample size equivalent to the number of indepen- achieved higher LPFs. The GM LPF for the no fit check group dent readings. For our data this correction reduced the sample was 140, while the group using fit checks had a GM' LPF of sizes from 23 to 65 percent. 291.

After receiving training, no attempt was made to conect In this case the distributions were significantly different. The donning enors made by the test subjects, such as crossing use of a fit check as an aid to donning this type of respirator straps, forgetting to tighten straps, failure to mold nosepiece, significantly improved its overall performance in the chamber etc., during the testing phase. In the group using fit checks, test. The variability of the two distributions was not signifi-when the subject's assessment of the fit was solicited, no cantly different (Table 3).

attempt was made to correct or assist in performance of the fit A possible explanation for the fit check causing an overall check. For this group, fit check instructions were available for increase in the LPF distribution without changing the shape of reference if a subject cared to review them. the distribution is that performance of the fit .check caused subjects to take added care during donning. The added care EXPERIMENT rr. For the second experiment 64 subjects were resulted from doing the fit check and led to better donnings, trained to don the four respirators with the aid of the manu- causing a shift of the entire LPF distribution and not just of the facturer's suggested fit check procedures. Subjects from exper- lower tail.

iment I could not participate in experiment II. The training Figure 3 shows the L-P plot of the LPFs for the HE filtering and qualification criteria for subjects in experiment II were facepiece. The GM LPF for the no fit check group was 758, identical to those for the group trained to use fit checks in while the group using fit checks had a GM LPF of 1633. In this experiment I. case the distributions were not found to be significantly dif-On the day following their training, subjects donned and fit ferent.

checked two preadjusted versions of each of the four respira- The distribution of LPFs achieved with the group using fit tors. The respirators were preadjusted to produce a sufficient checks was shifted toward higher LPFs in the lower tail region.

number of poor fits to test the ability of fit checks to identify poor or improper fits. TABLE 3. Pooled Standard Deviations of LPFs for Groups During this phase of testing, subjects were instructed to don of Test Subjects Donning Respirators With and Without Performing the respirators as they normally would, except they were not to a Fit Check Procedure reform the nosepiece of the DFF respirators or readjust the Respirator No Fit Check Fit Check straps of the EF respirator. The fit check outcome (i.e., pass or fail) was noted and the subject underwent the LPF testing. The D/M DFF 0.229 0.211 outcomes of the two tests were then compared. D/F/M DFF 0.322 0.295 HEDFF* 0.657 0.519 Results and Discussion D/MEF 0.413 0.465 LPFs from the group donning respirators without fit checks *A significant difference in variances exists between the fit check and no fit were compared to the LPFs obtained from the group donning check groups.

APPL.OCCUP. ENVIRON.HYG. Effectiveness of Fit Check Methods 939 10(11) NOVEMBER 1995 819.819 001.00 1_,._~IQI u*ui.

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1 (O):i (OU 100 moo 10000 !Ol.cn ilO 100 1000 FIGURE 2. Distributions ofLPFs obtained on two groups of-subjects donning a D/F/M DFF with and without using fit checks. FIGURE 4. Distributions ofLPFs obtained on two groups of subjects donning a D/M EF with and without using fit checks.

This shift resulted in a significantly lower variability than with the no fit test group (Table 3). With the HE respirator, elastomeric facepiece. The GM LPF for the no fit check group conducting a fit check had the effect of improving the quality was 608, while the group using fit checks had a very similar of respirator donnings, thereby elitninating the lower LPFs. GM LPF of 580. The distribution of LPF values for the two The shift in the lower tail of the LPF distributions for the groups is very similar, indicating that no improvement in the D/M and HE DFF respirators implies that performance of the quality of donnings was achieved by doing fit checks.

fit check did not tend to improve the fitting characteristics of A possible explanation for this observation is the small those respirators beyorid removing poorer fits. For the D/F/M number of lower LPF values: only 5 percent of each popula-DFF respirator, performance of fit checks resulted in a signif- tion, or two subjects, had LPFs around 100 or less. The small icant average improvement in LPFs, not just in the lower tail number of donnings actually resulting in LPF values below 100 ofthe distribution. reduces the opportunity to observe the value of a fit check

• Figure 4 shows the L-P plot of the LPFs for the D/M (i.e., to remove the lower LPFs). This could also explain wh the characteristic shift in the tail region toward higher fit factors for the group using fit checks is not seen with this respirator, but was observed with the D/M and HE DFF s;-.a~ I I

9181.81 I_,._ U"IJIQ u 11* l!.,U U\sill\\§l 1 respirators.

--fit Cl ~([;ik~; i'il= An alternative explanation for this observation is that per-9)9) formance of fit checks was not effective at detecting poorer r donnings. However, this explanation is questioned by the 815 j¥ 91!0 results from experiment II, which found that performing fit

~ID l checks on the EF respirator resulted in the best estimate of

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The effect of performing the fit check on the proportion of subjects achievil)g LPFs greater than ten was also examined.

The value of ten represents the assigned protection factor for half-facepiece respirators. (l,Z) The LPF data collected in these 5 ,,,. i.---"'

'j

/ studies were not always lognormally distributed (see Figures 1 through 4). As a result, binomial statistical methods were used to analyze the data collected from this phase.

(O)J The observed and corrected (Satterthwaite's correction) val-Cl.Oli ues of the number of donnings where resulting LPFs were less than ten .are listed in Table 4. Only the corrected values were used in subsequent analysis. A binomial approximation to the hypergeometric distribution was used to compare the propor-FIGURE 3. Distributions of LPFs obtained on two groups of subjects tions of donnings resulting in LPFs of less than ten for the test donning a. high efficiency DFF with and without using fit checks. groups donning with versus without fit checks. (IS)

940 W.R. Myers et al. APPL.OCCUP. ENVIRON.HYG.

10(11) NOVEMBER 1995 TABLE 4. Proportion of Donnings Resulting in LPFs of Less Than Ten No Fit Check Group Observed Values Fit Check Group Ob~'erved Values Respirator Uncorrected CorrectedA  % < 10 Uncorrected Corre_ctedA  %< 10 DIM DFF 51152 2.34171 3.3A 01132 _Q/87 0.0A DIFIM DFF . 31171 1.49185 1.8A 01168 0158 0.0A HEDFF 111150 5.79/79 7.3B 21192 1.541148 1.oc DIMEF 01186 01113 0.0A 31186 1.681/104 1_6A Average 9.621348 2.76B 3.22/397 0.81c ASample size reduced via Satterthwaite statistical method. CJ 7) ..

B,cPercentages of donnings resulting in LPFs ofless than ten between the fit check and no fit check groups with different superscripts were significantly different.

For the HE filtering facepiece, the proportion of donnings the worker will readjust a respirator that is already donned resulting in LPFs ofless than ten was significantly lower for the correctly. Perhaps in the process the quality of the donning will test group donning with fit checks as compared to the test be improved.

group donning without fit checks. No difference was found Sensitivity of the fit check was calculated by taking the with the other three respirators. However, the data in Table 4 number of donnings resulting in LPFs of less than ten where do suggest that the performance of fit checks tends to lower the the subject said the respirator failed the fit check and dividing proportion of donnings, resulting in LPFs of less than ten for by the total number of donnings that actually resulted in LPFs the D/M and D/F/M filtering facepieces. ofless than ten. For a test to have perfect sensitivity, this value .

The method of performing the fit check with the three would be 100 percent. Table 5 gives the sensitivity and the. 95-:

filtering facepiece respirators differs slightly from the fit check percent confidence intervals determined for each respirator'.

method for the elastomeric respirator (i.e., the subject is check- The values were corrected for sample size via the Satterthwaite:*

ing for air flow around the face seal in the former case and for formula. **

buildup and maintenance of positive or negative pressure in The sensitivity of the elastomeric facepiece fit check proce-the latter case). A binomial approximation to the hypergeo- dure was not significantly different than the sensitivity of the fit metric distribution was used again, this time to compare the check procedure used for the filtering facepieces.

proportions of donnings resulting in LPFs of less than ten for Specificity was calculated by dividing the number of don:-

the elastomeric facepiece and the filtering facepieces. nings resulting in LPFs of ten or higher, where the subjects faid *

• For subjects donning with fit checks, there were no signif- they passed the fit check, by the total number of donnings ..

• icant differences between the proportion of donnings resulting resulting in LPFs of ten or higher. For a test with perfect in LPFs ofless than ten for the elastomeric facepiece or any of specificity, this value would be 100 percent. Table 6 shows the*

the filtering facepieces (see Table 4). specificity determination made on each respirator corrected for**

The effect of the fit check on the variability of LPFs sample size via the Satterthwaite formula, and the 95 percent chieved with multiple donnings was also examined for each confidence interval for each value. A contingency table analysis espirator. The pooled standard deviations for subjects using fit of the specificity values found that fit checks done on the checks compared with the pooled standard deviations for sub- D/F/M DFF respirator resulted in significantly better speci-jects not using fit checks are given in Table 3. The variability ficity than with the other respirators. There is no obvious in LPF measurements was found to be significantly lower for explanation for this finding.

subjects using fit checks with the HE filtering facepiece. No significant differences were seen in the variability of LPF TABLE 5. Sensitivity Estimates Determined for Fit Checks Conducted on measurements for the other respirators. However, a slight Four Types of Half Facepieces reduction in pooled standard deviations for subjects using fit 95% Confidence checks was observed with the D/M and D/F/M filtering Respirator Best EstimateA Intervals facepieces.

Experiment II was conducted to measure the discriminatory DIM DFF 24.3/27 73.4-97.5%

power of fit checks to differentiate between acceptable don- (90%)

nings (i.e., those donnings resulting in LPFs of ten or better) DIFIM DFF 3.214 45.0-96.2%

and unacceptable donnings (i.e., those donnings resulting in (80%)

LPFs of less than ten). The discriminatory power of a test is HEDFF 23/23 85.0-100%

determined by its specificity and sensitivity. Specificity is the (100%)

ability of the test to accurately identify a correctly donned DIM EfB 31131 89.0-100%

respirator. Sensitivity is the ability of the test to accurately (100%)

identify an incorrectly donned respirator.

Sensitivity is calculated by taking those donnings resulting in LPFs ofless than Of these two parameters, the sensitivity of the test is most 10 that were identified by the test subject as a fit check failure, divided by all important. In this case, sensitivity relates to the chance of a the donnings resulting in LPFs of less than 10.

worker unknowingly wearing a respirator that is not properly AThe observed values reported here have been corrected for sample size via the Satterthwaite formula.< 17) donned into a hazardous environment. The specificity is not as 13 Sensitivity value detem1ined for the EF was not significantly difference than critical since the consequence of this error is most likely that the sensitivities observed on the DFFs.

APPL.OCCUP.ENVIRON.HYG. Effectiveness of Fit Check Methods 94 1 10(11) NOVEMBER 1995 TABLE 6. Specificity Estimates Determined for Fit Checks Conducted on averaged 66 percent for all four respirators. Considering that fit Four Types of Half Facepieces check methods are very simple to perform and require no 95% Confidence ancillary equipment, the sensitivity and specificity for these Respirator Best EstimateA Intervals methods are remarkably good.

Inexperienced workers can be trained in performing suc-DIM DFF 35.4/64 43-68% cessful fit checks on elastomeric and disposable filtering face-(55%) piece RPE. It is expected that with additional experience D/F/M DFF 75.9/88 77-93% respirator users might develop better and more consistent fit (86%)B check skills, thereby further improving the quality of respirator HEDFF 39.4/69 45-70% donning. Therefore, we conclude that for wearers of respira-(57%) tors that have been properly fit by a recognized fit test, D/MEF 36.8/64 45-70% conducting fit checks according to the manufacturer's instruc-(57%) tions can be a useful tool for more consistently maintaining the Specificity is calculated by taking the number of donnings with fit factors of quality of respirator donning.

ten or greater that were fit check passes and dividing by the total number of donnings with fit factors of ten or greater.

AThe observed values reported here have been corrected for sample size via the Acknowledgments Satterthwaite formula. (I 7 )

BA contingency table analysis found that the specificity for this respirator is The authors acknowledge Stuart J. Janis, IS&DP Statistical significantly better than the specificity of the other respirators. Consulting, 3M, St. Paul, Minnesota, and Kenneth L. Simp-son, Carol R. Rhoe, David L. Dimartino, Jeanne 0. Bidwell Haskell E. Mullins, and Craig Colton, Occupational Health and Environmental Safety Division, 3M, St. Paul, Minnesota.

Condusions The LPF results obtained from these studies found that em- References ploying a manufacturer's recommended fit check when don- 1. American National Standards Institute: American National Stan-ning a respirator helped detect and prevent poorer-quality dard for Respirator Protection. ANSI Z88.2-1980. American donnings of the respirator. As the quality of donnings increases, National Standards Institute, Inc., New York (1980).

2. American National Standards Institute: American National Stan-the usefulness of fit checks as a tool to evaluate the donning-dard for Respirator Protection. ANSI Z88.2-1992. American with the goal of further improvement-becomes less. The National Standards Institute, Inc., New York (1992).

better the facepiece seals to the face, the more difficult it is for 3. Pritchard, J.A.: A Guide to Industrial Respiratory Protection.

the wearer to differentiate whether subtle changes in pressure DHHS(NIOSH) Pub. No.76-189. National Institute for Occu-or air flow have occurred. pational Safety and Health, Cincinnati, OH (1976).

Results observed on the D/M DFF respirator suggest that 4. Code of Federal Regulations, Title 29, Part 1910, Subpart 134.

U.S. Government Printing Office, Washington, DC (as amended when fit checks are used for donning respirators which have Nov. 12, 1982).

considerable filter penetration, the resulting improvement in 5. American Conference of Governmental Industrial Hygienists the quality of a donning may be considerably less important in Respiratory Protective Devices Manual. ACGIH, Cincinnat determining the net performance. A fit check helps evaluate OH (1963).

the integrity of the face seal. As filter leakage becomes a more 6. American National Standards Institute: American National Stan-significant component of total in-board leakage, the relevance dard for Respirator Protection. ANSI Z88.2-1969. American of conducting a fit check decreases. National Standards Institute, Inc., New York (1969).

7. Hardis, K.E.; Cadena, C.A.; Carlson, GJ.; et al.: Correlation of Donning respirators with fit checks did decrease the likeli-Qualitative and Quantitative Results from Testing Respirator hood from 2.8 to 0.81 percent of those donnings resulting in Fit. Am. Ind. Hyg. Assoc. J. 44(2):78-87 (1983).

LPF values of less than ten. However, the decrease was only 8. Code of Federal Regulations, Title 29, Part 1910, Subpart Z, statistically significant with the HE DFF respirator. Section 1025-Appendix D, 190-194. Lead Standard. U.S.

Performing a fit check was found to produce a general Government Printing Office, Washington, DC (7-1-91 Edition).

reduction in the variability of the LPFs measured on the three 9. Marsh, J.L.: Evaluation of Saccharin Qualitative Fitting Test for DFF respirators. The reduction was significant for one of the Respirators. Am. Ind. Hyg. Assoc. J. 45(6):371-376 (1984).

three. 10. Oestenstad, R.K.; Dillion, H.K.; Perkins, L.L.: Distribution of Faceseal Leak Sites on a Half-Mask Respirator and Their Asso-The general trend toward fewer unsuccessful donnings and ciation with Facial Dimensions. Am. Ind. Hyg. Assoc. J. 51(5):

more consistent donnings when fit checks were used implies 285-290 (1990).

that fit checks have value in assisting the wearer to properly 11. Guy, H.P.: Respiratory Protection Committee, Respirator Per-don a respirator. formance Terminology. Am. Ind. Hyg. Assoc. J. 46(5):B-22 Fit check methods applied to the DFF respirators were (1985).

found to be equivalent to the fit check methods applied to the 12. Iverson, S.G.; Danisch, S.G.; Mullins, H.E.; et al.: Validation of EF respirator by all criteria used in the study to assess fit checks. a Quantitative Fit Test for Dust/Fume/Mist Respirators: Part I.

Appl. Occup. Environ. Hyg. 7(3):161-167 (1992).

The sensitivity of the fit check to detect bad donnings of

13. Yu, C.; Diu, C.: Total and Regional Deposition of Inhaled previously fit tested respirators averaged 96 percent for all four Aerosols in Humans. Journal of Aerosol Science 14:599-609 respirators. Conversely, the percentage of subjects accurately (1983).

identifying properly donned respirators with the fit check 14. Parkes, W.: Inhaled Particles and Their Fate in the Lungs. In:

942 W.R. Myers et al. APPL.OCCUP.ENVIRON.HYG.

10(11) NOVEMBER 1995 Occupational Lung Disorders. Butterworths, London, UK Test for Dust/Mist Respirators: Part II. Appl. Occup. Environ.

(1982). Hyg. 7(4):241-245 (1992).

15. Lippman, M.; Yeates, D.; Albert, R.: Deposition, Retention, and 17. Snedecor, G.W.; Cochran, W.G.: Statistical Methods. Iowa State Clearance ofinhaled Particles. British Journal ofindustrial Med- University Press, Ames, IA (1980).

icine 37:337-362 (1980). 18. Hiltner, L.F.: When Is Different Not? Lengthy Calculations May

16. Danisch, S.G.; Mullins, H.E.; Rhoe, C.R.: A Quantitative Fit Be Avoided. Quality Journal April:24-25 (1977).

AM. IND. HYG. ASSOC. J. 56:717-724 (1995) 312 THE ASSIGNED PROTECTION FACTOR OF 10 FOR HALF-MASK RESPIRATORS/

Thomas J. Nelson NIHS Inc., 240 I East Mall, Ardentown, DE I 98 IO ANSI. Are there significant differences between these differing A number of researchers have published or presented papers styles and constructions of masks that warrant different levels of on workplace protection factor (WPF) studies involving half-assigned protection? The few studies that contain data with the mask respirators. Individually, each study contains a rela-differing styles and types of respirators do not contain enough tively small amount of data, generally less than 25 data data points to allow these questions to be answered. The WPF points for any single respirator. Because of the small amount studies contain few data points because these studies are difficult of data, any attempt to quantify the result statistically does to perform and require a Iarge*amount of manpower and money not provide useful information on the low end of the distri-to collect each sample.

bution of WPFs. Several studies on half-mask respirators The technique of meta-analysis has been used to evaluate were combined to yield a data set with 390 observations. Of the information from clinical trials and used in epidemiology to these WPF data, 1.5% were less than JO, the best estimate increase the statistical power by combining the information from of the 5th percentile was 13, with a 95% confidence interval a number of related studies. To do such an analysis though re-of 10 to 18. Differences between the mean WPF based on the quires several questions to be addressed:< 3J Are all studies to be type offilter were found, but no difference was found between included or only published ones? Are all studies to be included the mean performance of elastomeric and disposable respi-or only the "good" ones? When the study results are hetero-rators equipped with dust/mist and dust/fume/mist filters.

geneous, how may they be included in a.meta-analysis, or should they be used at all?

number of studies have estimated the performance of In this analysis the data from published and unpublished half-mask air purifying respirators through the use of studies on respirators have been reviewed. Each study was an-workplace protection* factor (WPF) studies. o.s-i 7i One alyzed to determine if the research protocol used was similar and use of the information from these studies has been the assign- if flaws in study design and data collection existed that would ment of protection factors. not allow the information to be combined. Rather than a strict The reported performance of half-mask respirators for these statistical analysis of data as would be done in a meta-analysis, udies has been in terms of the best estimate of the 5th percen- the data from similar studies were simply pooled into a single

e. Little use has been made of confidence intervals to better data set.

escribe the uncertainty involved in these estimates. The prob-lem in using confidence intervals is that the studies used to define performance have generated a relatively small amount of data with a large amount of variation. For example, in the Nelson and STUDIES EVALUATED Dixon study of respirator performance during asbestos removal, the North respirator showed a mean protection factor of 245, For this analysis the studies on half-mask air purifying respira~

with a geometric standard deviation of 6.5.< 1J The best estimate tors listed by Johnston et al. in their review article on perfor-of the 5th percentile was 11 with 95% confidence limits of I.I mance testing were evaluated.<4 > These include published and to 37. It is obvious that this information by itself is not useful in unpublished studies. A summary of the studies is provided in setting an assigned protection factor, since the range includes 1 Table I; the unpublished studies are noted.

or no protection assignable. Dixon and Nelson studied the performance of a Survivair A second issue in assigning protection factors is how to half-mask respirator equipped with high efficiency particulate air group the widely varying styles and construction of masks. (HEPA) filters in a lead chromate pigment production facility.< 5J Within the group of half-mask respirators, the American Na- To qualify for the study, a person was required to pass an isoamyl tional Standards Institute (ANSI) 288.2 committee combined acetate qualitative fit test. Eleven people participated in the elastomeric and disposable types into a single class, with an as- study. The samples were collected for a single wearing of the signed protection factor of 10.< 2> The type of filter or cartridge respirator that lasted from 30 minutes to 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />. Samples were also does not change the assigned protection factor according to analyzed by proton induced X-ray emission (PIXE) for lead with a detection limit of approximately 10 ng per sample. The mass mean aerodynamic diameter of the particles was measured at This work was funded in part by the 3M Company. 1.8 µm.

Copyright 1995, American Industrial Hygiene Association AM. IND. HYG. ASSOC. J. (56) / July 1995 717

TABLE I. Summary of the Studies Respirator Filter Analytical Detection

• Liu # Particle Size Study Type Type Fit Test Ana/yte Method Limit Probe People (Mean)

Dixon Gaboury" elastomeric HEPA isoamyl lead PIXE 2 ng sample no 11 1.8µm elastomeric DM quantitative BAP HPLC 0.003 µg/m 3 yes 22 <0.52 µm DFM (100 min FF)

Lenhart elastomeric HEPA quantitative lead AA 0.2 µg sample yes 25 9-16 µm or 1-(250 min FF) Onside resp.) 10 µm Reed disposable DM quantitative cement mass 0.01 mg sample yes 7 8-20 µm (min FF not dust given)

NelsonA disposable DM,DFM, saccharin asbestos fiber count 0.0006 fibers/ml yes 17 0.49µm elastomeric HEPA Gosselink" disposable DM, DFM saccharin asbestos fiber count 0.001 fibers/ml yes 12 elastomeric HEPA JohnstonA . disposable DM saccharin Ti, Al, Si PIXE 9-35 ng per yes 5 sample Colton-bra~ disposable HEPA saccharin Pb,Zn PIXE <10 ng per yes 17 dust and fume sample both present Colton-Af disposable DM saccharin Al PIXE <10 ng per yes 5 -10µm sample Galvin elastomeric Charcoal irritant smoke styrene GC 1 µg/sample no 13 cartridge Myers-foundrie~ elastomeric DFM saccharin, Zn,Pb PIXE <1 Ong per yes 25 dust and fume disposable quantitative sample both (min 100 FF) present

-aircraft'\ elastomeric HEPA quantitative Ti, Cr PIXE <10 ng per yes 22 (min FF 100) sample

-steel milf elastomeric DM saccharin Fe PIXE,AA <10 ng per yes 17 dust and fume disposable sample both present Colton-weldingA disposable DFM saccharin Fe, Mg, PIXE <10 ng/sample yes 20 dust and fume Zn, Ti both present Wallis disposable DM saccharin Mn AA 0.004-0.006 yes C; -60% > 10 mg/m3 as Mn no Co µm AStudies that have not been published Gaboury and Burd studied the performance of Wilson, Sur- as possible, so the data represents a WPF for multiple wearings vivair, and American Optical half-mask respirators equipped in each work shift. The lead was analyzed by atomic adsorption with organic vapor/acid gas cartridges and either dust/mist (DM) with a detection limit of 2 to 5 µg for the lapel samples and 0.2 or dust/fume/mist (DFM) filters in a primary aluminum refin- µg for the in-mask samples. The mean aerodynamic particle di-ery. <6> They measured benzo-alpha-pyrene, contained in the ben- ameter in the sinter plant was 9 to 16 µm, and 1-10 µmin the zene soluble materials present in the process. The analytical de- blast furnace area.

tection limit was 0.003 µg/m 3

• To qualify for the study, each Reed et al. studied the performance of a 3M 9910 DM res-subject needed to pass a qµantitative fit test with a minimum fit pirator in .a concrete patching mixing and bagging area.< 8> To factor of 100. Twenty-two people participated in the study. Be- qualify for the study a quantitative fit test was performed, to look cause of the heat load in the production areas, workers spent for gross leakage. No minimum fit factor was given for inclusion one-half hour each hour in a cool environment. The sampling in the study group. Seven people participated in the study. The was stopped during this time period. Therefore, each data point mass collected inside and outside the respirators was determined is a WPF for multiple wearings in each work shift. The mean by weighing after desiccation. The mean aerodynamic diameter particle size was less than 0.52 µm. of the particulate was measured at 8 to 20 µm depending on Lenhart and Campbell studied the performance ofMSA half- location within the worksite.

mask respirators equipped with HEPA filters in a primary lead The Nelson and Dixon study was conducted during asbestos smelter in the sinter plant and blast furnace areas.<7>To qualify abatement operations with the 3M 8710 DM, 3M 9910 DM, for the study a person was required to pass a quantitative fit test Survivair half-facepiece respirator with DFM and HEPA filters, with a minimum fit factor of 250 required. The 25 workers who and the North 7700 with.HEPA filters.°> To qualify for the study, participated wore the respirators for as much of the 8-hour shift subjects passed a saccharin qualitative fit test. Seventeen people AM. IND. HYG. ASSOC. J. (56) / July 1995 718

participated in the study. Samples were collected for 30 minutes Another study not listed was one by Galvin et al_<l 4 > They to 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />. Each WPF data point represented a single wearing. studied the performance of a half-mask respirator equipped with The asbestos fibers were analyzed by phase contrast microscopy, organic vapor cartridges in a styrene atmosphere. The samples with a modification to increase the number of fields counted to were collected for three to six I -hour periods for each of the 13 increase sensitivity. The detection limit of the method was ap- people who participated in the study. To qualify for the study, proximately 0.0006 fibers/mL for a 100 L sample, with a reliable the person needed to pass an irritant smoke qualitative fit test.

limit of quantification of approximately 0.006 fibers/mL. Samples were analyzed by gas chromatography-flame ionization Gosselink et al. evaluated the performance of the 3M 8710 for styrene. The inside samples were corrected for lung retention.

DM, 3M 9910 DM, 3M 9920 DFM, and 3M 7000 series half- A study by Myers 05 > that is being prepared for publication facepiece respirator with HEPA or DM filters in a brake manu- was also evaluated. In this study, DM, DFM, and HEPA filter facturing facility.< 9> To qualify for the study, the person needed respirators with both disposable and elastomeric face pieces were to pass a saccharin qualitative fit test. Twelve people partici- studied in a variety of workplaces. These included three foun-pated, and samples were collected for approximately 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />. dries, an aircraft painting facility, and a steel mill. Fit testing was The asbestos fibers were counted using phase contrast micros- accomplished with a quantitative fit test for the elastomeric res-copy, with a modification to increase the number of fields pirators and the saccharin qualitative fit test for the DM and DFM counted to increase sensitivity. The detection limit for the sample disposable respirators. The minimum fit factor required to pass size collected inside the respirator (2 Umin, 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />) would the quantitative fit test was 100. Sixty-four people participated have been about 0.001 fibers/mL based on the modified counting in the study. Samples were analyzed by PIXE for the inside method. samples and all outside samples except those from the steel mill.

Johnston and Mullins studied the performance of the 3M Because of the large amounts of material collected on the outside 715 DM respirator in a metal fabricating facility.< 10> The filters at the steel mill, the samples were analyzed by atomic usts analyzed were titanium, aluminum, and silicon. Samples absorption.

were collected for 35 to 235 minutes and included multiple Wallis et al. studied the performance of a 3M 8710 dispos-wearings for a single WPF determination. The metals were able respirator in a battery manufacturing facility .<1 6> Seventy analyzed by PIXE. To qualify for the study, the person needed samples were collected on a num~er of people in various areas to pass a saccharin qualitative fit test. Five subjects partici- of the operation. Employees were hot trained or fit tested during pated. the time of the study, but had prior training and fit testing. The Colton and Mullins measured the performance of a samples were collected on cellulose ester filters and analyzed by maintenance-free high efficiency respirator in a brass foundry.° 1> atomic absorption. The detection limit was 0.004 to 0.006 mg/

The respirators were worn for 30 minutes to 4.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />, each m3, and the concentration of manganese outside the respirator sample a single wearing of a respirator. To qualify as a partici- ranged from 0.14 to 77.4 mg/m3

• Area samples collected for pant, each person was required to pass a saccharin qualitative fit particle sizing showed that more than 60% of the mass was test. Seventeen people participated. The samples collected out- greater than 10 µm in diameter, the largest size selector used in side the respirator were respirable dust samples. Dust and fume the impactor. Less than 10% of the dust was smaller than 2 µm were both present. Depending on the area of the plant, 20 to 60% in diameter.

f the mass of the aerosol was greater than 10 µm. The samples A recently reported WPF study by Pallay was not included ere analyzed for lead and zinc by PIXE, with a level of quan- in the analysis.< 17> For this study preliminary results have been fication of less than 10 ng. reported at various meetings, but the data collected were not A study by Colton et al. was conducted in an aluminum available.

smelter.< 12> The respirator studied was a 3M 9906 with a DM Several of the very first half-facepiece respirator studies, filter. The samples collected outside the respirator were respi- such as those by Revoir,< 13>Moore, Smith,< 19> and Smith et al.< 20>

rable dust. The samples were analyzed by PIXE, with a level of were not included in this analysis, since they were not WPF quantification less than 30 ng. To qualify as a participant, each studies. They were effective protection factor studies, where in-person was required to pass a saccharin qualitative fit test. Work- mask sampling included the time while the respirator was not ers were sampled for the duration of the task, so each data point . being worn. Also, they were conducted before the more recently represents a single wearing of the respirator. Twenty-four work- developed and validated fit test methods became available.

ers were sampled over five days. The particle size analysis by a cascade impactor shows approximately 50% of the dust was greater than 10 µmin diameter. ANALYSIS OF THE STUDIES Several studies not listed in the Johnston article also were evaluated. <4 > These included a study by Colton and Mullins, who For the data from several studies to be combined, the methods determined WPFs for a DFM disposable respirator worn during used to collect the WPF data needed to be evaluated to determine welding and grinding operations.< 13> Twenty employees wore the if they were similar enough in design and execution to allow respirators. Samples were collected for 40 to 190 minutes with them to be grouped. The portions of a WPF study that have an four sample sets a day collected. Fit testing was done by the effect on the outcome include the test subjects familiarity with saccharin method. Samples were analyzed by PIXE for iron, the respirator, motivation to participate, their training in proper magnesium, zinc, and titanium. Particle size analysis showed fitting and use, the method of fit testing, and the methods for both dust and fume were present. sample collection and analysis.<4 > Training, familiarity with the AM. IND. HYG. ASSOC. J. (56) / July 1995 719

respirator, motivation, and proper use are variables that are gen- WPF value was found.<1°> It appears that in the workplace stud-erally described but cannot be evaluated objectively. Methods of ied, the concentration of the contaminants was so low as to affect fit testing and sample collection and analysis can be evaluated the WPF results seen. In their data they used a cut-off point of objectively. at least 10 times the mean blank value, but suggest that a value Fit testing is an important variable. The protection factor is of 100 be used as a minimum. The review article by Johnston strongly dependent on the properties of the facepiece, including also recommends that the outside sample weight equal at least how well the facepiece seals to the wearer's face.< 21 i Fit testing 10 times the assigned protection factor times the mean field determines which respirators are suitable. This is recognized by blank.<4> For a half-mask this would equal a value of 100. Be-many standards, such as ANSI Z88.2, that require a fit test to cause the low outside concentrations had an effect on the WPF select respirators.<2> The definition of a WPF also requires that measured, this study was eliminated from the analysis.

the respirator be properly selected, fitted, and tested.' 22 > In the Colton and Mullins study, the outside-the-respirator To determine a WPF requires that the concentrations outside samples were collected as respirable dust samples.° 1J Myers et and inside the respirator be measured. Since a WPF is calculated al. have shown using transmission electron microscopy that large as the ratio of these two concentrations, sample collection and particles do penetrate inside the respirator facepiece.< 26>Collect-analysis directly affect the WPF observed. ing outside-the-respirator samples as respirable dust samples will Analytical methods used need to be specific and accurate bias the observed WPF, making the WPF appear lower than ac-over a wide range of concentrations. A study of half-mask res- tual if a large part of the material in the workplace is removed pirators may result in WPF values from less than 10 to over by the cyclone. Depending on the area of the plant, 20 to 60%

10 000 based on observed quantitative fit factors. The environ- of the mass of the aerosol was greater than 10 µm and would ment inside a facepiece is high in humidity and at a temperature not be collected by the cyclone.

near 35°C. The concentration inside the facepiece will likely be In the Colton et al. study at an aluminum smelter, respirab 10 to 10 000 times lower than the ambient concentration, where dust samples were collected as outside samples.<1 2>Impactor da the analytical method has been validated. The collection of sam- collected during the study suggests that approximately 50% of ples from this environment must not be affected by these extreme the dust present was not collected on the outside samples. There-conditions. fore the outside samples biased the observed WPFs, making them appear lower than actual.

In the Wallis study several points need to be exarnined.< 16l Studies Rejected Because of Inadequate Fit Tests First, the C0 and Ci samples were collected by different methods.

The Ci samples were collected by probing the respirator with a The study by Galvin et al. used the irritant smoke fit test as sample inlet designed by Liu< 27>to minimize sample loss at the outlined in the ANSI Z88.2 (1980) standard.< 14> The level of inlet. In contrast, the C0 samples were collected with a closed smoke that leads to a response by the person being tested is face and the Liu probe was not used. This caused the outside checked, but the concentration at which a response occurs is not samples to underestimate the concentration of manganese. As known. Unlike the isoamyl acetate and saccharin fit tests,'23>the shown by Liu, a similarly designed inlet would have almost 30%

level of irritating smoke generated during a test was not mea-of the particles larger than 10 µm deposited in the inlet compared sured with the specific protocol. Both the saccharin<24l and the to almost no deposition with the Liu probe. The authors poi isoamyl acetate test protoco1s<25 >have been studied, and experi-out that the concentration outside the respirator was related ments have verified the concentrations for taste or odor sensitiv-the WPF found. For all data points the best estimate of the 5 ity and test concentration.

percentile was 7.5; when only data for C 0 samples greater than In the study by Reed et al. the quantitative fit test used was 100 times the detection limit are used, the 5th percentile is 10.8; not appropriate for the respirator being used.cs> An oil mist quan-when data 1000 times the detection limit are used (5 mg), the titative fit test requires the use of HEPA filters so that face seal 5th percentile is 35.

leakage can be separated from filter leakage. In this study the respirator had a DM filter.. In addition the analytical method was a mass determination by weighing. Since the material being mea- Acceptable Studies sured was a cement product, the inside-the-mask samples would The following studies are included in the analysis. They have been in a humid environment and would include moisture included an acceptable qualitative fit test with a protocol that would be chemically reacted in the cement matrix. In ad-based on one listed in the Occupational Safety and Health dition the test is not specific; other material such as sweat and Administration lead standard< 23 >or a quantitative fit test. The sputum collected on the filter also would be included in the inside analytical methods employed were specific, and the ratio of mass. These factors would bias the inside-the-respirator samples, the outside concentration to the detection limit was in each increasing filter weights and decreasing the observed WPF.

case 100 or more.

In the Lenhart and Campbell study, the ratio of the outside Studies Rejected Because of Inadequate concentration to the detection limit of the analyte was at least Concentration Measurements 40 and averaged well over 100.(7) The lowest outside mass value reported was 92 µg/m 3 , with a detection limit of 2 µg/m3; the In the WPF study by Johnston and Mullins a relationship lowest ratio was 46 (based on a sample time  ;;r 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> at 2 L/

. between the mass of the analyte outside the respirator and the min with a detection limit reported at 2 µg/m 3). Fit testing was AM. IND. HYG. ASSOC. J. (56) / July 1995 720

TABLE II. Summary of Study Parameters 5th 95th Study N GM GSD Percentile Percentile Reason Not Included Studies included in the analysis Dixon 42 3360 4.8 254 44400 GabouryA 18 47 2.5 10 210 Lenhart 25 166 3.8 18 1500 NelsonA 76 258 5.2 17 3900 Gosselin~ 44 96 2.3 24 390 Colton-weldinif 32 147 2.5 33 660 MyeraA 153 346 7.2 14 8800 Studies not included :in the analysis Reed 19 18 3.17 2.7 120 nonspecific analytical, biased inside samples, QNFT not HEPA filters JohnstonA 18 44.8 2.85 8 251 low inside the facepiece weights Colton-brass 38 28.2 2.06 8.6 92 outside samples biased foundryA Colton-Al smelte~ 42 469 3.87 50 4338 outside samples biased Galvin 63 75 3.1 11.7 482 used unvalidated QLFT Wallis 70 50 3.5 7.5 400 biased and low outside concentrations AStudies that have not been published by a recognized quantitative fit test method. The required fit In the Gaboury and Burd study, the ratio of benzo-alpha-factor to be included in the study was 250, which is higher-than pyrene. was more than 2500 times the average concentration out-the other studies under consideration. The effect of this higher side the respirator (detection limit of 0.003 µg/m 3 versus an av-fit factor on the observed WPFs is unknown. However, fit factors erage concentration of 7 .97 µg/m 3). c6>Fit testing was done using have not been shown to be a predictor of WPFs. c5,27> a quantitative fit test method with a minimum fit factor of 100.

In the Dixon and Nelson study, the ratio of the outside In the Colton and Mullins study, samples were analyzed for concentration to the detection limit was well above 100 (the zinc, titanium, magnesium, and iron during welding.< 13>For zinc average outside concentration was 225 µg/m3, based on a I - the inside concentration ranged from 0.1 to 9.7 µg/m 3

• For I hour sample time and the detection limit; the lowest concentra- outside-the-respirator samples, concentrations were from 4.2 to tion that could be measured was approximately 0.1 µg/m 3)_c5 > 1062 µg/m3. With a detection limit of approximately 15 ng/filter it testing was done using the isoamyl acetate fit test. The in- (or approximately 0.05 µg/m 3), the concentration outside the res-mask samples were collected without the probe designed by pirator averaged well over 100 times the detection limit. The Liu, c23> which was designed to minimize sample loss on the WPF values for zinc were used in the analysis purely for con-probe surfaces. The effect of the use of a non-Liu designed venience.

probe on the sample results is unknown, since most of the par- In the Myers et al. study the mean concentration inside the ticles were of the size range where the probe design has less of respirator was well above 100 times the detection limit.< 15>For an effect on deposition. example, the concentration of zinc outside the respirator in the In the Gosselink et al. study the average asbestos fiber con- first study site was 12.2 to 629 µg/m 3

• The detection limit was centration was 2.21 fibers/cc, approximately 100 times the de- approximately 0.08 µg/m 3 for a 2-hour sample. In the foundry tection limit of 0.02 fibers/cc.< 9> Fit testing was with the sac- portion of the study the outside samples were collected as res-charin protocol.c23J In the Nelson and Dixon study with asbes- pirable dust samples; however, these were corrected to yield total tos, the median fiber concentration was 2.6 fibers/cc outside the dust weights, and these data were used in the calculation of the respirator, approximately 100 times the detection limit of 0.02 WPFs. For the other study sites total dust samples were collected fibers/cc.<1> Fit testing was with the saccharin protoco1.c 23 > In on outside samples. Fit testing was by either the saccharin qual-both studies the closed-face sampling technique was verified itative fit test<23>or a quantitative fit test with minimum fit factor not to have adversely affected the deposition of fibers on the of 100 required.

filter surface by a comparison of closed-face and open-faced sampling. Nelson and Dixon also measured the deposition of fibers on the filter, which was zoned into three concentric and RESULTS OF THE ANALYSIS equal areas (outer, middle, inner). For both closed- and open-faced samples, the fiber density was not significantly different Using the WPF results from the included studies, geometric among the zones. means (GM), geometric standard deviations (GSD), and the best AM. IND. HYG. ASSOC. J. (56) / July 1995 721

interval was calculated to deter-5 mine which types of filters were significantly different.< 29> The 4.5 mean performance of respirators 4 equipped with HEPA filters was 0

found to be significantly higher

~ 3.5 z

1*

than the respirators equipped with 0

i:lw 3 either DM or DFM filters. The 0

...~ 2.5 1 11 I mean WPF for the respirators equipped with DM filters was sig-I 0

... 2 l

3

~ 1.5 l nificantly higher than that for the respirators with the DFM filters.

Next the data were grouped

~ and analyzed according to respi-0.5 rator type: elastomeric or dispos-able. Since there were significant 0

differences between filter types, Gaboury Lenhart Nelson Dixon GosseHnk Myeis Colton each was examined separately.

FIGURE 1. Range of 5th percentile, geometric mean, 95th percentile For the DM filter types, elasto-meric respirators were used in the Gaboury (4), Gosselink (8), and Myers (30) studies; disposable estimates of the 5th and 95th percentiles were calculated using respirators were used in the Nelson (32), Gosselink (22), and 28 LOGAN.< > These values are shown in Table II. A plot of the Myers (21) studies. For the DFM filter types, elastomeric res-geometric mean, 5th, and 95th percentiles from each included pirators were used in the Gaboury (14), Nelson (15), and Myers study show that the studies resulted in comparable ranges of (46) studies; disposables in the Gosselink (8), Myers (20), and WPF measurements (Figure 1). Since the studies cover compa- Colton welding (32) studies. Tables V and VI summarize the rable ranges of data, they were combined into a single data set. statistical parameters for the respirators equipped with the two This resulted in 390 data points. Of these 390 data points, 6 types of filters. A student's t-test shows that the WPFs do not WPF values (or 1.5% of samples) were less than 10. A log prob- differ between mask types with a P (two tailed) of 0.54 for the ability plot of the data is shown in Figure 2. The geometric mean DM and 0.25 for the DFM.

is estimated at 290, with a GSD of 6.5. The best estimate of the A comparison cannot be made for HEPA filter respirators, 5th percentile is 13, with a 95% confidence interval of 10 to 18. since there are no disposable HEPA-filtered respirators included This is consistent with the assigned protection factor of 10 listed in this analysis.

by the ANSI Z88.2 (1992) standard.<2>

A one-way analysis of variance of these data separated into categories by filter type (Table III) showed there was a signifi-cant difference among the mean WPFs with a p-value less than CONCLUSION 0.00001 (Table IV). Using an a. of 0.001, a multiplet confidence The ANSI Z88.2 (1992) standard defines the assigned protection factor as the minimum expected workplace level of respiratory protection that would be provided by a properly functioning res-pirator or a class of respirators to properly fitted and trained users. "<2> The ass1gne

. d protection

• factor for half-mask respira-i'"

'1..

10,000 tors is 10. For the studies examined in this analysis, the 5th C

.g 1.000 I. 0 100 TABLE Ill. WPF Data for Filter Type Dust-Mist Fume HEPA

-a Study Number GM Number GM Number GM t:0 10

~ ,: Gaboury 4 48 14 46 Lenhart 25 166

.999 .99 .9 .5 .1 .01 .001 Nelson 32 428 15 183 29 177 Probability Dixon 42 3356 Gosselink 22 93 8 233 6 56 FIGURE 2. Probability plot of combined data set Myers 51 260 66 144 36 3983 Colton 32 146 AM. IND. HYG. ASSOC. J. (56) / July 1995 722

TABLE IV. Analysis of Variance for Filter TypeA TABLE VI. Comparison of Elastomeric and Disposable N Avg (as Log1oJ SD Respirators With DFM Filters Study Elastomeric Disposable DusVMist 117 2.32 0.35 DusVFume/Mist 135 2.08 0.34 Number 75 60 HEPA 138 2.96 0.88 GMWPF 107 141 GSD 4.4 3.3 ss df MS F p Fent 5th perct. 9.5 19.4 95th perct. 1210 1020 Between filters 56 2 28 52.28 >0.0001 3.51 Within filters 208 387 0.54 A Where N = number of data, SD = standard deviation, Avg = mean, SS = When the differing styles of respirators were examined, the sum of squares, df = degrees of freedom, MS = mean square, F = F statistic, p = probability disposable respirators had a mean WPF that was not significantly different from that for the elastomeric respirators ~quipped with either DM filters or DFM filters. Therefore, there appears to be percentile of WPFs was 13 with the lower 95% confidence in- no reason to assign different assigned protection factors to the terval of 10. This appears to support the assigned protection fac- two types of mask construction, elastomeric and disposable, for tor for this class of respirators. This conclusion is based on the these two types of filters.

combination of data from a number of studies assumed to be The performance of DM, DFM, and. HEPA filters when com-similar. Many factors can affect the data collected during a WPF paring the 5th percentiles was not that different and was not study, and several of these factors cannot be evaluated objec- inconsistent with the assigned protection factor of 10. If the as-tively, such as the level of motivation of a subject participating signed protection factor was based on an average level of pro-in a study. As noted by Johnston, many studies have been re- tection, then the differences seen would be significant. Other ported at professional and scientific meetings, but not yet pub- factors will effect the protection a respirator provides, such as lished in the literature. <4 > This required that a critical review be wear time (which is not considered in WPF studies). Wear time performed with these before they were included with the pub- may be affected by comfort, employee motivation, and other lished studies. factors. These other factors are further reasons why a higher When type of filter was examined, the mean WPF for res- assigned protection may not be reasonable, even though differ-pirators equipped with HEPA filters was significantly higher than ences in mean performance have been seen.

that for respirators equipped with either DM or DFM filters, and the respirators equipped with DM filters have a significantly higher mean WPF than the respirators equipped with DFM fil- ACKNOWLEDGMENTS ters.

Leakage into a respirator will be governed by several factors The author wishes to thank Warren Myers and Craig Colton for including filter efficiency, face-seal leakage, and leakage through providing access to the data in their studies and support in pre~

defects such as a faulty valve. Depending on the particle size of paring the article.

n aerosol, a respirator with a HEPA filter may be expected to erform better than a respirator with either a DM or DFM filter.

Campbeli<21 > predicts that a comparison of two filters, one REFERENCES with higher particle penetration and lower filter resistance, will have a GM WPF value that is higher than the other filter. He 1. Nelson, TJ. and S.W. Dixon: Respirator protection factors for as-compared a filter with a penetration of 0.001 and a resistance of bestos, parts I and Il. Paper presented at the American Industrial 25 mm (Hg) to a filter with a penetration of 0.003 and resistance Hygiene Conference, Las Vegas, NV, May 23, 1985.

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and lower filter resistance when compared to a DFM filter, which New York: ANSI, 1992.

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Epidemiol. 44(2):127-139 (1991).

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GMWPF 191 224 Prot. 2(4):347-361 (1984).

6. Gaboury, A. and D.H. Burd: Workplace protection factor evalu-GSD 3.75 4.05 ation of respiratory protective equipment in a primary aluminum 5th perct. 21.7 22.4 smelter. Paper presented at the International Society for Respiratory 95th perct. 1680 2240 Protection Conference, San Francisco, CA, November 1989.

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7. Lenhart, S.W. and D.L. Campbell: Assigned protection factors for at lead acid battery manufacturing facilities. Paper presented at the two respirator types basep upon workplace performance testing. American Industrial Hygiene Conference, Orlando, FL, May 1990.

Ann. Occup. Hyg. 28(2):173-182 (1984). 18. Revoir, W.H.: Respirators for protection against cotton dust. Am.

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pirator workplace protection factor study on a half-mask dust/mist 23. "Occupational Safety and Health Standards," 29 CFR 1910 respirator. Poster presented at the American Industrial Hygiene (1910.1000 to end), 1990. pp. 156-194.

Conferednce, Orlando, FL, May 1990. 24. Marsh, J.L.: Evaluation of saccharin qualitative fitting tests for res-

13. Colton, C.E. and H.E. Mullins: Workplace protection factors for a pirators. Am. Ind. Hyg. Assoc. J. 45:371-376 1984.

half-mask dust/mist/fume respirator. Poster presented at the American 25. Nelson, T.J., O.T. Skretvedt, J.G. Loschiavo and S.W. Dixon: De-Industrial Hygiene Conference, Salt Lake City, UT, May 17, 1992. velopment of an improved qualitative fit test using isoamyl acetate.

14. GaJvin, K., S. Selvin, and R.C. Spear: Variability in protection J. Int. Soc. Respir. Prot. 2(4):225-8 (1984).

afforded by half-mask respirators against styrene exposure in the 26. Myers, W.A., Z. Zhuang, T. Nelson, S. Sides, et al.: Field perfor field. Am. Ind. Hyg. Assoc. J. 5I:625-639 (1990). mance measurements of half-facepiece respirators-study protocol.

15. Myers, W.: "Discussion of Preliminary Data. NPCA Respirator Am. Ind. Hyg. Assoc. J. [In press.]

Study." April 23, 1990. [Private Conversation.] Dr. Warren Myers, 27. Liu, B.Y.H., K.L. Dega, K.L. Rubow, S.W. Lenhart, et al.: Mask University of West Virginia, P.O. Box 6101, Morgantown, WV 26506. aerosol sampling for powered air purifying respirators.-Am. Ind.

16. Wallis, G., R. Menke, and C. Chelton: Workplace field testing of Hyg, Assoc. J. 45:278-283 (1984).

a disposable negative pressure half-mask dust respirator (3M 8710). 28. LOGAN, Workplace Exposure Evaluation System. [Computer-Soft-Am. Ind. Hyg. Assoc. J. 54:576-583 (1993). ware.] American Industrial Hygiene Association, 1990.

17. Pally, B., J. Gample, L. Jerman, J. Allender, et al.: Workplace 29. Dowdy, S. and S. Wearden: Statistics for Reseacrch. 2nd. ed. New __

protection factor (WPF) study of particulate air purifying respirators York: John Wiley & Sons, 1991. pp. 321-323.

AM. IND. HYG. ASSOC. J. (56) / July 1995 724

AMERICAN INDUSTRIAL HYGIENE ASSOCIATION JOURNAL 57:735-740 ( 1996) 513 The Assigned Protection AUTHOR Factor According to ANSI T.J. Nelson The American National Standards Institute (ANSI) standard for respiratory protection NIHS Inc., 2401 East Mall, (ANSI 288.2 1992) lists assigned protection factors (APFs) for various respirators.

Ardentown, DE 19810 The committee that developed the APFs based its decisions on a review of available studies of respirator performance. If workplace studies were available, these formed the basis for the number assigned. If no such studies were available, then laboratory studies, design analogies, and other information were used to decide what value to assign. For half-mask air purifying respirators, four workplace protection fa ctor studies were consulted to arrive at an APF. For loose-fitting facepiece powered air purifying respirators (PAP Rs), five workplace studies and two laboratory studies were reviewed.

For full-face air purifying, helmet/hooded PAP Rs, and most supplied air respirators no workplace studies were available. The APF was based on laboratory studies or decided by analogy to other equipment. For the remaining respirators only single workplace protection factor studies were available, and these were used by the committee to assign an APF. The database available to the ANSI committee was limited. Most of the studies available for review were not published. The committee in a sense was required to perform peer review on the information to use the data. Studies completed after the ANSI committee finished its deliberations, when added to the data used, continue to support the APFs assigned by ANSI.

Keywords: ANSI Z88.2, assigned protection factor, respirators he assigned protection factor (APF ) is (published or unpublished), these formed the basis T defined as the minimum expected work-place level of respiratory protection that would be provided by a properly function-ing respirator or class of respirators to a stated percentage of properly fitted and trained users.1 1l for the number assigned. If no such studies were available, then laboratory studies, design analo-gies, and other information were used to decide what value to assign. Table I lists the APFs devel-oped by the committee. For each type of respira-The APF is used to select respirators based on the tor a summary of the workplace and laboratory expected concentration of a contaminant in the studies used by the ANSI committee and studies workplace. A respirator with an APF greater than completed after their review are given below.

the hazard ratio is chosen as the minimum The summary statistics for each study are required respirator.1 21 The hazard ratio is defined shown in Tables II through IV. For each study by ANSI as the concentration in the workplace the statistics have been recalculated where inside divided by the exposure limit.< 2 l samples were below the detection limit of the In developing the list of APFs, the American analytical method. This was done to make the National Standards Institute (A.,,~SI) Z88.2 com- calculations uniform and to minimize the bias for mittee based its decisions on a review of available estimates of the geometric mean and geometric studies of respirator performancePl Most of the standard deviation. Waters has shown that a value studies that have been done are not in the pub- of 60 to 70% of the detection limit when substi-lished literature. The committee had to review the tuted for samples with concentrations below the information available for a study and make a deter- detection limit minimizes the bias in estimating mination of acceptability of the work. If workplace these statistical parameters.141 A value that was protection factor (WPF) studies were available 70% of the detection limit was used.

Copyright 1996, American Industrial Hygiene Association AIHA JOURNAL (57) August 1996 735

included the studies used by ANSI and other studies conducted RESPIRATOR TYPES EVALUATED after the ANSI committee concluded their deliberations.

Air Purifying Respirators Full-Facepiece Air Purifying Respirators An air purif)1ing respirator is a respirator in which ambient air is The ANSI committee did not find any data from studies on full-passed through an air purif)1ing clement that removes the contam- facepiece air purifying respirators that were conducted after the inant( s ).121 Air is passed through the air purifying clement by means APF of 100 was assigned by the 1980 ANSI standard.1 61 Based on of the breathing action (negative pressure) or by a blower ( powered not finding any new data, no change in the APF was warranted.

air purif} ing respirators, or PAPRs ). Negative pressure air purif)*ing 1

Since then Colton reported on a WPF study in a secondary lead respirators are equipped with either quarter-mask, half-mask, or full smelter.' 71 The subjects who participated were quantitatively fit-facepieces. ANSI places quarter masks and elastomeric and disposable tested, with a minimum fit factor of 500 required to participate.

half masks in the same categorv of half masks. ANSI classifies PAPRs Samples were analyzed by proton induced X-ray e_missi_on (PIX~)

as half-mask, full-face, hcl~et/hoods, or loose-fitting facepieces. with a detection limit of 10 ng lead per filter. Particle size analysis Half-Mask Air Purifying Respirators showed that both fume and dust were present. Approximately 65%

of the particles were greater than 10 µm, and 15% were less than 0.9 Nelson' 51 reviewed a number of WPF studies that included those um. Thirtv-two WPF values were obtained. The geometnc mean used by the ANSI committee and studies that were conducted at a WPF was 4790, with a geometric standard deviation of 7. The best later d~tc. Table II lists the statistical data from these studies. Based on estimate of the 5th percentile was 194, which is consistent with the the estimates of the 5th percentile for these studies, the ANSI commit- A..~SI APF of 100.

tee assigned an APF of 10 for half-mask air purif)'ing respirators. 161 The study by Reed' 251 was not considered to be a valid indica- Half-Mask PAPRs tor ofperfor~1a~ce by the ANSI committee. The analytical method Mvers and Peach studied the performance of half- and full-face-used to measure the dust inside the facepiece was mass, which is pi~ce PAPRs equipped with HEPA filte!s in a silica b_agging o~e nonspecific. The dust was a cement product, so water from hydra- ation. 18 1 Samples were collected on :, µm pore size polyvmy tion was included in the measurement of the mass. Also, the respi- chloride filters, analyzed gravimetrically and by X-ray diffraction.

rator studied, the 3M 9920, cannot be fit-tested properly with an The detection limit for the mass determination was 0.03 mg silica/

oil mist quantitative fit-test. The fit-test requires that high effi- sample; for the X-ray diffraction method, 0.005 mg silica/sample.

ciency particulate air (HEPA) filters be used. With dust/?1ist Samples were collected for multiple wearings, with the PAPRs filters, faceseal leakage and filter leakage are measured. Therctore, removed during meal times and other breaks. Individual samples the fit-test is not measuring respirator fit. were collected for morning and afternoon shifts. Four workers The author concluded that the assigned protection factor of 10 were involved. The mass mean aerodvnamic diameter was mea-was appropriate based on a statistical analysis that showed the 5th sured at 5.5 and 5.8 um on two of the three days the study was percentile of the WPF data to be greater than 10. The studies used conducted. The resea;chers reported that leakage of silica occurred where the breathing tube connected to the blower, TABLE I. Assigned Protection Factors from ANSI 288.2 {1992)A which could have let unfiltered air pass the filter Respiratory Inlet Covering and enter the blower housing. Thus this study Half Full Helmet/ Loose-Fitting may not predict actual performance of a half-Type of Respirator Mask 8 Facepiece Hood Facepiece mask PAPR.

!.!:...:....:..:...:..:..::::..'.:..:.:.::..:..:._ _ _ _ _ _ _ _ _ _ _ __ : _ _ _ _ _ _ _ _ _ _ _ _ Lenhart and Campbell studied the p e r f o .

Air purifying 10 100 mance of a half-mask PAPR equipped wi Powered air purifying 50 1000c lOOOc 25 HEPA filters in a primary lead smelteri 91 Twenty-Atmosphere supplying five subjects participated. To participate, each 0

SCBA (demand) 10 100 had to pass a quantitative fit-test with an MSA Air line (demand) 10 100 half-mask respirator with a fit factor of 250. The Air line samples were analyzed by atomic absorption, Pressure demand 50 1OOO with a detection limit of 2-5 µg lead per sample.

Continuous flow 50 lOOO 1OOO 25 Inside-the-facepiece samples ( C;) ofless than 10 µg Self-contained breathing lead were analyzed by graphite furnace atomic Apparatus pressure absorption with a detection limit of 0.2 µg lead Demand open/closed Circuit per sample. The study was conducted in two sep-AThis material is reproduced from the American National Standard ANSI Z88.2 copyright 1992 arate areas of the facility. The sinter plant area par-with permission by the American National Standards Institute (ANSI). Copies of this standard ticle size had mass mean aerodvnamic diameters may be purchased from ANSI, 11 W. 42nd St., New York, NY 10036. . .

of 9-16 um while the furna~e area had mass Blncludes quarter mask, disposable half mask, and half masks with elastomenc facep1eces.

cProtection factors listed are for high-efficiency filters and sorbents (cartridges and canisters). mean aer~dv~amic diameters of 1-8 µm. Three With dust filters, an APF of 100 is to be used due to the limitations of the filter. C; samples *were below the limit of detection.

0 oemand SCBA should not be used for emergency situations such as firefighting.

Using a value of 70% of the detection limit, the EAlthough positive pressure respirators are currently regarded as_ providing the highest level geometric mean WPF is 431; the best estimate of of respiratory protection, some recent simulated workplace studies concluded th_at all users may not achieve protection factors of 10,000. Based on this l1m_1ted data a definitive APF could the 5th percentile is 58.

not be listed for positive pressure SCBAs. For emergency planning purposes where hazardous daRoza et al. reported on a simulated work-concentrations can be estimated, an APF of no higher than 10,000 should be used. place protection factor (SWPF) study on a half-Note: Assigned protection factors are not applicable for escape respirators. For combination mask PAPR.1 10 1 The penetration into the respirators, e.g., air-line respirators equipped with an air purifying filter, the mode of operation facepiece was measured during exercise on a in use will dictate the APF to be applied.

treadmill. Airflow was controlled to the facepiecc 736 AlHA JOURNAL (57) August 1996

TABLE II. Workplace Protection Factors-Negative Pressure The committee also reviewed a report by Ayer on a laboratory Air Purifying Respirators study of full -facepiece PAPRs equipped with HEPA filters in a chamber with a silica dust aerosol.<12 > Samples inside the facepiece Geometric Best were collected at 12 L/min, outside samples at approximately 1.5 Geometric Standard Estimate L/min. Four subjects participated in the test and were sampled Studies Available to Committee N Mean Deviation 5th Peret.

while moving bags of material inside the chamber. Samples were Half mask analyzed by weighing the filters. The simulated protection factor obtained showed a correlation with the chamber concentration.

Dixon'24> 42 3360 4.8 254 When the data were divided into two groups, low and high cham-Reed' 25 >.A 19 18 3.17 2.7 ber concentration, the mean simulated protection factors were Lenhart 1261 25 166 3.8 18 3389 (low) and 5580 (high ). These data were considered consis-Nelson 127> 76 258 5.2 17 tent with the APF chosen.

Subsequent data Since the APF was assigned, Colton ct al. reported on a study Gosselink128> 44 96 2.3 24 with a full-faccpiece PAPR in a secondary lead smclterY 3 l Twenty Gaboury 1201 18 47 2.5 10 workers were quantitatively fit-tested with TSI Portacount fit-test Colton (welding) 129> 32 147 2.5 33 units. The minimum fit factor required was 500. Samples were col-Myers130> 153 346 7.2 14 lected for a period of 1 to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />. All samples were analyzed for Johnston 1311*8 18 44.8 2.85 8 lead by PIXE, with a detection limit of 10 ng lead/sample.

Colton (brass foundry)1 32 >-8 42 469 3.87 50 Samples less than 1000 times the detection limit were excluded Colton (Al smelter) 133l,B 38 28.2 2.06 8.6 from the analysis. The 5th percentile WPF of 1400 is consistent Galvin 134>.B 63 75 3.1 11.7 with the APF of 1000.

llis'3sJ.s 70 50 3.5 7.5 Helmet/Hooded PAPRs lfacepiece There were no WPF studies available for PAPRs with helmets or No WPF studies available; hoods. The APF of l 000 was assigned by the ANSI committee since no new data, no based on analogy to an air-line respirator operating at the same change from 1980 standard flow rates. 16 1 Subsequent data Since then Keys et al. reported on the performance of three hel-Colton(?) 32 4790 7 194 met/ hood type PAPRs in a pharmaceutical manufacturing facil-icy.1141 The respirators were a Racal Breathe Easy 10, Bullard AANSI and Nelson concluded that sampling bias may have been a factor in Quantum, and the 3M Whitecap II. Inside the inlet, covering sam-the WPF measured 8

Nelson concluded that sampling bias may have been a factor in the WPF ples were collected for 30 minutes to 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> and analyzed for measured estradiol benzoate by a radio immunoassay technique with a limit of quantification of 50 picograms estradiol benzoate per sample.

Outside the respirator, samples were analyzed by high performance by replacing the battery pack with a DC power supply and varying liquid chromatography. Probe loss was determined to be less than the voltage to obtain the airflow desired. Simulated WPFs were l %. The best estimate of the 5th percentile WPF, 1470, is consis-casured by a light-scattering photometer. For the half-faccpiccc tent with the APF assigned by the ANSI committee.

R the penetration remained constant at the varying work lev-ith an SWPF of approximately 5000. Loose-Fitting Facepiece PAPRs Skaggs ct al. reported on simulated workplace studies with an The committee had several WPF studies on loose-fitting facepiece MSA half-mask PAPR.1 11 > Simulated WPFs were measured by PAPRs to guide them in assigning an APF. The summary statistics light-scattering photometry in a chamber with temperature and for the studies are shown in Table II.

humidity controls. Various exercises were performed, such as shov- Meyers ct al. studied the performance of the 3M Airhat and eling, hammering, moving blocks, and pounding a board with a the Racal model AH3 loose-fitting facepiecc type PAPRs equipped sledgehammer. The mean SWPFs for the various temperatures and with dust/mist filters in a battery manufacturing facilicy. 115 1 Twelve humidities were from 14,300 to 20,000 . workers participated in the study, with samples collected for the Since the Myers and Peach data may not have been a realistic full 8-hour shift, with the sampling pumps turned off during the estimate of performance, the Lenhart data was the only WPF data times the PAPR was not being worn. The inside-the-facepicce available to the ANSI committce .< 6 l The APF selected by the ANSI probe was located approximately 1-2 inches from the mouth. The committee was 50. With a geometric mean WPF of 431 and a 5th inside-the-facepiecc samples were analyzed by graphite furnace percentile of 58, the APF selected is consistent with the Lenhart atomic absorption with a detection limit of0 .3 µg lead per sample.

data. The two simulated workplace studies are consistent with the The outside samples were analyzed by atomic absorption with a APF. No new studies have been reported on the half-mask PAPR detection limit of 3 µg lead per sample. The particles in the work-since the ANSI committee completed their work. place had a mass mean aerodynamic diameter of 17 µm . The geo-metric mean WPF was 127, and the best estimate of the 5th Full-Facepiece PAPRs percentile WPF was 32.

The committee did not have anv WPF data on full-face PAPRs Gossclink ct al. studied the performance of the 3M Airhat with (other than the Myers and Peachi8 l study discussed above ).' 6 l A \'alue HEPA filters in a brake manufacturing facility.! 16 1 The asbestos of l 000 was chosen for the APF based on being consistent with the fibers were analyzed by phase contrast microscopy, with a modifica-APF chosen for the helmet/ hood style as discussed below. Some tion to increase the number of fields counted to increase sensitivity.

felt that the full-face PAPR would perform better than a helmet or The detection limit was 1 fiber/filter. The geometric mean WPF hooded PAPR. Choosing the same value is a conservative approach. was 199, and the best estimate of the 5th percentile WPF was 41 .

AIHA JOURNAL (57) August 1996 737

Myers et al. studied the performance of Racal AH3 and 3M point above the visor. Because of the heat load in the production Airhat loose-fitting facepiece PAPRs equipped with high-efficiency areas, workers spend one-half hour each hour in a cool environ-filters in a secondary lead smelter.!17! Twelve subjects participated, ment; for this time period the sampling was stopped. Therefore, and each was given a quantitative fir-test before being included in each data point equals the WPF for multiple wearings in each work the study. A fit factor of 1000 was required, and since no one had shift. Both bearded and clean-shaven subjects were included in the a fit factor less than 1000, the fit-test was not a factor in the study study. The geometric mean WPF was 1410; the best estimate of outcome. Samples were collected during the entire shift while the the 5th percentile was 306.

respirator was worn. The inside-the-facepiecc samples were ana- Stokes et al. studied the 3M Airhat loose-fitting facepiece PAPR lyzed by graphite furnace atomic absorption with a detection limit equipped with dust/mist or HEPA filters, and a version of the of 0.3 µg lead per sample, the outside samples by atomic absorp- equipment with a Tyvek shroud P 11 The study was conducted in tion with a detection limit of 3 µg lead per sample. The particle a roofing granule production plant and measured silica dust. Five size of the aerosol varied by area of the plant. At the furnace and subjects participated. Samples were collected for 30 minutes to 1 caster, approximately 35% of the aerosol was greater than 17 µm, hour. Only samples with inside concentration greater than 25 or and 30% smaller than 0.68 µm. At the blast furnace, 60% was 100 times the mean blank concentration were included in the greater than 17 µm and 8% smaller than O (-,.-~ !Im. The geometric analysis. The geometric mean WPF was 1530; the best estimate of mean WPF was 184, and the best estimat ~ , ,r the 5th percentile the 5th percentile was 85.

WPF was 27. These studies support the APF assigned by the ANSI committee.

Que Hee and Lawrence studied the pe:<Hmance of Racal Airstream AH3 and AH3- l loose-fitting facepiece respirators Atmosphere-Supplying Respirators equipped with high-efficiency filters for two job classes in a brass Atmosphere-supplying respirators supply a resp:rable atmosphere foundry.(18 ) For furnace room attendants, samples were collected independent of the workplace atmosphereP 1 Une type is com-for 4 to 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> including breaks and lunch. For the ladle atten- monly called an air-line respirator and operates in one of three dants, samples were collected only during pouring, which lasted 3 modes: demand, continuous flow, or pressure demand. Deman to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />. Seven subjects participated in the study. Samples were and pressure demand can be equipped with either half-face or full-analyzed by flame atomic absorption spectroscopy. In this study, facepiece inlet coverings. The continuous flow type can also be the Ci samples included time in which the shield of the PAPR was equipped with a helmet/ hood or a loose-fitting facepiece . A sec-raised, making most of the data an effective protection factor study. ond type of atmosphere-supplying respirator is equipped with a Also, the authors noted that low flows were measured due to low self-contained air supply. These are either self-contained breathing battery charge. The committee did not use the information from apparatus or are used in combination with a pressure demand sup-this study in setting an APF. plied air-line respirator. A summary of the information used by the Dixon et al. performed a program protection factor (PPF ) ANSI committee is presented in Table III.

study on the 3M Airhat loose-fitting facepiece PAPR equipped with dust/mist filters _n 9 J As opposed to WPF studies where Demand Supplied Air, Half- or Full-Facepiece Respirators the equipment is verified to be properly working and used, the PPF The ANSI committee did not find any new information on these data is collected as the respirator is used in the workplace. No types of units. The APF of 10 was based on analogy to the half-checks are made on the function of the equipment and its use. mask air purifying respirators_l 6 )

Seven subjects participated in the study. Samples were coHected for the duration of a specific task that lasted 30 minutes to 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />. Continuous Flow Atmosphere Supplying Respirators Analysis of samples was by PIXE with a limit of detection of 10 to There were no workplace studies on half-mask or loose-fittin 100 ng, depending on the analyte, per filter. The geometric mean facepiece supplied air respirators. The APF of 50 for the half-mas PPF was 230, but the data did not play a role in the decision to and 25 for the loose-fitting facepiece was based on analogy to the assign an APF. PAPRs, where the same airflows are required by NIOSH for certi-Two simulated workplace studies were also reviewed, one by fication .(6) For the full-facepiece supplied air respirator, there was daRoza and the other by Skaggs, that were previously described. no workplace data. The APF was set at 1000 to be consistent daRoza tested two loose-fitting facepiece PAPRs, a 3M Airhat and with the helmet/hood style, with no evidence to set it either Racal Breathe Easy l. Skaggs tested 3M Airhat and Racal AH3 higher or lower.

loose-fitting facepiece respirators. daRoza found mean SWPFs of For helmet/hood type supplied air respirators, the committee 100 and 10 when the work rate was at the maximum. Skaggs was briefed on a WPF study by Johnston.<6 ) The study, which was found mean SWPFs of 1900 to 5600 for the 3M Airhat and 1200 later reported at a technical conference,!2 2 ) was conducted during to 3500 for the Racal AH3 . sand blasting of a barge . Samples were analyzed for silica by PIXE.

After reviewing the WPF studies described above, the ANSI A relationship was found between the loading on the outside filters committee concluded that an APF of25 was appropriate for loose- and the mean WPF. When samples with mean loadings greater fitting facepiece PAPRs.( 6) than 1000 times the mean blank loading were used to estimate the Since the committee completed their work, two more studies 5th percentile, the estimate was 1038. Skaggs studied a helmet/

have been reported. First, Gaboury and Burd measured the work- hood type in the simulated workplace study. The mean simulated place performance of a Racal Breathe- Easy PAPR equipped with WPFs for the various conditions ranged from 7500 to 20,000.

HEPA filters.( 201 They measured benzo-alpha-pyrene, which is Based on this information, an APF of 1000 was assigned.(6 )

contained in the benzene soluble materials present in the particu-late in the aluminum smelting process. Benzo-alpha-pyrene was Pressure Demand Respirators detected at 0.003 µg/ m'. Seventy-five percent of the benzo-alpha- Pressure demand respirators can have the air supply delivered by an pyrene was contained in an aerosol with an aerodynamic diameter air line, a self-contained cylinder, or in combination. There was no of 0.93 µm. Samples were collected outside the respirator at a workplace data on either a half-mask or full-face pressure demand 738 AIHA JOURNAL (57) August 1996

TABLE Ill. Workplace Protection Factors-Powered Air measured in quantitative fit-test chambers. SCBAs are generally Purifying Respirators chosen not by the need for a definitive level of protection, but rather for specific situations (e.g., firefighting, emergencies ). They Geometric Best are considered the highest level of protection available for these Geometric Standard Estimate types of situations. The APF is considered less meaningful.

Studies N Mean Deviation 5th Peret.

Half mask Lenhart1261 25 431 3.4 58 CONCLUSION Myers & Peach 181 7 49 2.5 11 he assigned protection factor (APF ) is defined as the minimum daRoza (simulated work data) 1101- 5000 Skaggs (simulated work data) 1111- 14300-20000 T expected workplace level of respiratory protection that would be provided by a properly functioning respirator or class of respira-Full facepiece tors, to a stated percentage of properly fitted and trained users.(IJ Ayer (simulated work data) 1121 The stated percentage of properly fitted users has not been set by Myers & Peach 181 3 66 3.6 8 any group.

In reporting the results of WPF studies, the best estimate of the Subsequent data 5th percentile has been reported as representing an estimate of the Colton(13) 55 10300 3.4 1400 APF by a number of authors.(7- 9,l3-I 7,2 0-24 ,31- 33,35 i The ANSI com-Helmet/hood mittee used the estimate of the 5th percentile as one of the factors in judging the results ofWPF studies. (6 l There appears to be some Decision based on analogy consensus that the APF should be set so that at least 95% of the to atmosphere supplied time a subject wearing a respirator will not be exposed above the et/hood data exposure limit.

bsequent data For some types of respirators very little data beyond single Keysl14J 60 10400 3.3 1470 workplace studies are available for analysis and estimating perfor-mance. In most cases the APF assigned by the Ai~SI committee Loose-fitting facepiece was based on operational analogies to similar types of equipment.

Myers (battery) 1151 47 127 2.3 32 If the goal is to have assurance that the exposure limit will not Gosselink1161 7 199 2.6 41 be exceeded, more research on the performance of respirators in Myers (smelter) 1171 43 184 3.3 27 the field is needed. Also, agreement is needed to define the statis-Que Hee 1181 tical parameters of performance that will be assumed. Is an APF, daRoza (simulated work data)1101- defined as the 5th percentile of workplace data, protective of worker Skaggs (simulated work data)11 11 - health? Or should another definition for the APF be defined)

Dixon (program protection factor) 1191 230 TABLEIV. Workplace Protection Factors-Atmosphere Subsequent data Supplying Respirators 20 1410 2.5 306 Type of Respirator APF Assignment 39 1530 5.8 85 Demand Half mask No WPF data, APF assigned based on pplied air respirator. Skaggs et al. did include a full-face air-line analogy to negative pressure respirators model in their study. The mean simulated WPFs for the various Full facepiece No WPF data, APF assigned based on conditions ranged from 8500 to 20,000 . daRoza reported to the analogy to negative pressure respirators committee on a simulated workplace study with a self-contained air supph. 1' The respirators were MSA self-contained breathing appa- Continuous flow rJtus (SCBA) models with regulators that comply with the airflow Half mask No WPF data, APF assigned based on n.:quirements of the National Fire Protection Association stan- analogy to powered air purifying rdpirators dard .' 23 ; Simulated WPFs were measured while the subjects walked Full face No WPF data, APF assigned based on on a treadmill with the speed and elevation set to achieve a work analogy to powered air purifying respirator rate of 80% of the maximum heart rate. The lower 95% confidence Helmet/hood N=l 5, Geometric Mean=4O76, GSD=2.3, Best level of the geometric mean was 6000; the best estimate of the 5th Estimate 5th Peret.= 1038; Johnston1 221A percentile was 300. One subject had simulated WPFs less than 1000. Loose-fitting facepiece No WPF data, APF assigned based on The APFs of 50 for the half-mask and 1000 for the full -face- analogy to powered air purifying respirator piece pressure demand respirators were set based on analogy to PAPRs and continuous flow supplied air systems .1 61 The commit- Pressure demand tee believed that setting a higher APF because of the pressure Half mask No WPF data, APF assigned based on demand feature was not warranted, but rather that the total airflow analogy to powered air purifying respirator was critical. Full facepiece No WPF data, decision based on daRoza 1101 For self-contained breathing apparatus, no APF was assigned. (simulated work data) and by analogy to During the balloting process, consensus could not be reached on continuous flow respirator an APF. The committee noted that data have shown the perfor-AWPFs with outside filter weights> 1OOOX the background level on the blanks mance of this type of respirator may not be as good as previously AIHA JOURNAL (57) August 1996 739

While answers are clearly needed for these questions, the prac- 18. Que Hee, S.S. and P. Lawrence: Inhalation exposure of lead in brass ticing industrial hygienist still has to make decisions on the respi- foundry workers: the evaluation of the effectiveness of a powered air-purifying respirator and engineering controls. Am. Ind. Hyg . .&roe. J. 44:746-751 rators that will be used in the workplace. The APFs that were (1983 ).

assigned by the ANSI committee appear to be appropriate based

19. Dixon, S.W., T.J. Nelson, and J.E. Wright: "Program Protection Factor on the limited amount of information available. Study on the 3M W316 Airhat." Paper presented at the American Industrial Hygiene Conference, Detroit, MI, May 1984.

20. Gaboury, A., D.H. Burd, and R.S. Friar: Workplace protection factor REFERENCES eYaluation of respiratory protective equipment in a primary aluminum smelter.

Appl. Occcup. Environ. H_vg. 8(1):19-25 (1993).

1 American Industrial Hygiene Association Respiratory Protection 21. Stokes D.W., A.R. Johnson, and H.E. Mullins: "Respirator Workplace Committee: Letter to the Editor (respirator performance terminology ). Am. Protection Factor Studies-Powered Air Loose Fitting Helmet." Paper pre-Ind. H_v__q. Assoc. J. 46:B22-B24 (1985 ). sented at the American Industrial Hygiene Conference, Montreal, Canada, June 1987.

2. American National Standards Institute (ANSI): ANSI Z88.2 (1992),

American National Standard for Respirator_v Protection. New York: ANSI, 1992. 22. Johnston, A.R., D.W. Stokes, H.E. Mullins, and C.R. Rhoe:

"Workplace Protection Factor Study on a Supplied Air Abrasive Blasting

3. Nelson, T.J., D.P. Wilmes, and R.A daRoza: A..'\Sl Z88.2 (1992 ), Respirator." Paper presented at the American Industrial Hygiene Conference, Practices for respiratory protection. Am. Ind. Hyg. Assoc. J. 55:660-662 ( 1994 ). Montreal, Canada, June 1987.

4. Waters, M.A., S. Selvin, and S.M. Rapport: "The Eftcct of Censoring on 23. National Fire Protection Association (NFPA): "Open Circuit Self-Parameter Estimation for the Lognormal Distribution." Paper presented at the Contained Breathing Apparatus for Firefighters" (NFPA 1981). Quincy, MA:

American Industrial Hygiene Contcrcncc and Exposition, New Orleans, LA, NFPA, 1987.

May 1993.

24. Dixon, S.W. and T.J. Nelson: Workplace protection factors for negative

5. Nelson T.J.: The assigned protection factor of 10 for half-mask respirators. pressure half-mask facepiece respirators. J. Int. Soc. Respir. Prot. 2(4):347-361 Am. Ind. H_v,_q. Assoc. J. 56:717-724 ( 1995 ). (1984 ).

6. Nelson, T.J.: *'ANSI Z88.2 Committee Meeting Minutes." June 1987. 25. Reed, L.D., S.W. Lenhart, R.L. Stephenson, and J.R. Allende NIHS Inc., 2401 East Mall, Ardentown, DE 19810. Workplace evaluation of a disposable respirator in a dusty environment. Ap

7. Colton, C.E., H.E. Mullins, and C.R. Rhoe: "Workplace Protection Ind. Hyg. 2(2):53-56 (1987).

Factors for a hill Faccpiccc Respirator.~ Paper presented at the 1989 American 26. Lenhart, S.W. and D.L. Campbell: Assigned protection factors for two Industrial Hvgienc Contcrcncc, Saint Louis, MO, May 1989. respirator types based upon workplace performance testing. Ann. Occup. Hyg.

8. Myers, W.R. and M.J. Peach: Performance measurements on a powered 28(2):173-182 (1984).

air-purifying respirator made during actual field use in a silica bagging opera- 27. Nelson, T.J. and S.W. Dixon: "Respirator Protection Factors for tion. Ann. Occup. Hyg. 27:251-259 ( 1983). Asbestos, Parts I and II." Paper presented at the American Industrial Hygiene

9. Lenhart, S.W. and D.L. Campbell: Assigned protection factors for two res- Conference, Las Vegas, NV, May 23, 1985.

pirator tYpes based upon workplace performance testing. Ann. Occup. H_vg. 28. Gosselink, D.W., D.P. Wilmes, and H.E. Mullins: "Workplace 28:173-182 (1984). Protection Factor Study for Airborne Asbestos." Paper presented at the I 0. daRoza, R.A., C.A. Cadena-Fix, and J.E. Kramer: Powered air puril)*- American Industrial Hygiene Conference, Dallas, TX, May 1986.

ing respir.. tor studv. J. Int. Soc. Respir. Prot. 8(2):15-36 (1990 ). 29. Colton, C.E. and H.E. Mullins: "Workplace Protection Factors for a Half 11 . Los Alamos National Laboratory: Effects of Temperature and Humidity Mask Dust/ Mist/ Fume Respirator." Poster presented at the American on Respirator Fit Under Simulated Work Conditions by B.J. Skaggs, J.M. Loibl, Industrial Hygiene Conference and Exposition, Salt Lake City, UT, May 17, K.D. Carter, and E.C. Hyatt (Report LA 11236). Los Alamos, NM: Los 1992.

Alamos National Laboratory, July 1988. 30. Myers, W.: "Preliminary Data, NPCA Respirator Study," April 23, 1990

12. Ayer, H.E.: <<Report on Testing of Powered-Air Purif)-ing Respirators" [priYate communication] . University of West Virginia, P.O. Box 6101,

[unpublished report]. Uni\'crsity of Cincinnati, Cincinnati, OH, August 21, Morgantown, WV 26506.

1981. 31. Johnston, A.R. and H.E. Mullins: "Workplace Protection Factor Stu

13. Colton, C.E., H.E. Mullins, and C.R. Rhoe: "Workplace Protection for Airborne Metal Dusts." Paper presented at the American Industr Factors for a Powered Air-Purifying Respirator." Paper presented at the Hygiene Conference, Montreal, Canada, June 4, 1987.

American Industrial Hygiene Conference, Orlando, FL, May 1990. 32. Colton, C.E. and H.E. Mullins: "Workplace Protection Factor Test Brass

14. Keys, D.R., H.P. Guy, and M. Axon: "Workplace Protection Factors of Foundry." Paper presented at the American Industrial Hygiene Conference, Powered , Air-Purifi-ing Respirators." Paper presented at the American Orlando, FL, May 1990.

Industrial Hygiene Confi:rence, Orlando, FL, May 1990. 33. Colton, C.E., A.R. Johnston, H.E. Mullins, C.R. Rhoe, et al.:

15 . Myers, W.R.., M.J. Peach, K. Cutright, and W. Iskander: Field test of "Respirator Workplace Protection Factor Study on a Half Mask Dust/ Mist powered air purifying respirators at a battery manufacturing facility. J. Int. Soc. Respirator." Poster presented at the American Industrial Hygiene Conference, Rcspir. Prot. 4(1):62-89 ( 1986 ). Orlando, FL, May 17, 1990.

16. Gosselink, D.W., D.P. Wilmes, and H.E. Mullins: "Workplace 34. Galvin K., S. Selvin, and R.C. Spear: Variability in protection afforded Protection factor Study for Airborne Asbestos." Paper presented at the by half-mask respirators against styrene exposure in the field. Am. Ind. Hyg.

American Industrial Hygiene Contcrencc, Dallas, TX, May 1986. Assoc. J. 51:625-639 ( 1990).

17. Myers, W.R., M.J. Peach, K. Cutright, and W. Iskander: Workplace pro- 35. Wallis G., R. Menke, and C. Chelton: Workplace field testing of a dis-tection factor measurements on powered air-puril)-ing respirators at a secondary posable negative pressure hall:mask dust respirator (3M 87IO). Am. Ind. Hyg.

lead smelter: results and discussion. Am. Ind. H_vg. Assoc. J. 45:681-688 ( 1984 ). Assoc. J. 54:576-583 ( 1993 ).

740 AlHA JOURNAL (57) August 1996

3M Occupational Health and 3M Center. Building 260-38-09 Environmental Safety Dh ision St. Paul, MN 551--1- I000 31\11 June 3, 1997 Mr. Alan Roecklein Senior Health Physicist US Nuclear Regulatory Commission Office of Research 11555 Rockville Pike Rockville, MD 20852

Dear Mr. Roecklein:

It has recently come to the attention of the Minnesota Mining & Manufacturing Company (3M) that the Nuclear Regulatory Commission is updating its regulations governing the use of respiratory protection at nuclear facilities. 3M is the leading U.S.

manufacturer of industrial respirators, many of which are used at NRC-regulated facilities every day.

On behalf of 3M's Occupational Health & Environmental Safety Division, I submit the following comments for you to consider as these changes are being drafted. The comments are based on recent conversations with NRC staff and on early drafts of the revisions to 10 CFR Part 20 and Regulatory Guide 8.15, which delineate requirements for respiratory protection against radiation.

The regulation and guide closely follow the guidelines in the American National Standards Institute's voluntary consensus standard ANSI 288.2 (1992), "American National Standard for Respiratory Protection." ANSI 288.2 (1992) represents a consensus reached by experts in the field representing organized labor, industry, the federal government and respirator manufacturers. In several places, however, the NRC regulation and guide deviate from the program recommended in the ANSI standard.

In particular, there are significant discrepancies between some of the assigned protection factors (APFs) identified in the draft NRC documents and those in the ANSI standard. While there is considerable science supporting the protection factors assigned by ANSI, we are not aware of any scientific or technical support used by NRC to support the alternate values assigned in its documents. In the comments and attachments that follow, we provide a great deal of data supporting the ANSI values.

Mr. Alan Roecklein Page Two June 3, 1997 In addition, the NRC regulation and guide need to consider recent changes to the National Institute for Occupational Safety and Health's (NIOSH) criteria for certification of respirators. As you are probably aware, NIOSH published 42 CFR 84 in July of 1995.

This regulation completely revised the minimum performance characteristics for negative pressure ~ir-purifying respirators. Many of these products, which constitute the largest class of respirators, have very recently been tested and certified by NIOSH. Guidance in selecting and using these new 42 CFR 84 filters need to be incorporated into the NRC documents.

Enclosed is a copy of the Industrial Safety Equipment Association's (ISEA) 1996 "Use and Selection Guide For Non-Powered Air Purifying Particulate Respirators." This document, which 3M helped develop as a member of the ISEA Respiratory Protection Group, identifies a decision logic for selecting among the new 42 CFR 84 respirators. It may be helpful to you while drafting the proposed revisions to IO CFR 20 that will eventually be made available for public comment.

In the event that you desire clarification of any of these issues or the supporting documentation, please do not hesitate to contact me. I appreciate your consideration of 3M's comments and look forward to any feedback or further questions you may have.

Sincerely, Ronald E. King Regulatory Affairs Manager 3M Occupational Health & Environmental Safety Division REK:llb/11 Attachments c: M.E. Flora - OH&ESD - 275-6W-01 AR. Johnston - OH&ESD - 260-3B-09 R. McArver - The Jefferson Group M.L. Runge - OH&ESD - 260-3A-02

Comments on a draft of 10 CFR Part 20 and Regulatory Guide 8.15

§ 20.1703 (a)(l): This provision requires the use of equipment certified by NIOSH and the Mine Safety and Health Administration (MSHA). With the changes in the certification process embodied in 42 CFR part 84, MSHA is no longer involved in the direct certification of respirators. MSHA is only involved in the certification of respirators used in mine emergencies and mine rescue. The reference to MSHA certification, therefore, should be removed.

§ 20.l 703(3)(vi): As written, the paragraph is somewhat confusing. It requires "Fit testing, -with fit factor ~ 10 times the APF for negative pressure devices and ~ 100 for positive pressure and pressure demand devices. . . . " This implies that a fit factor of 100,000 (100 multiplied by the APF of 1,000) would be required for a pressure demand full facepiece supplied air respirator. In Regulatory Guide 8.15 it is clear that NRC only requires a fit factor of 100 for positive pressure devices. This should be clear in 10 CFR 20.1703(3)(vi) as well.

§ 20.1703(7): This paragraph requires that respirable air meet the minimum quality specified in the Code of Federal Regulations that describe NIOSH/MSHA approval requirements. In 42 Part 84, NIOSH lists the Compressed Gas Association Commodity Specification for Air, G-7 .1 1966. This is an outdated standard. NRC should specify the current standard, which was updated in 1989.

Appendix A To§§ 20-1001- 20.2402: Assigned Protection Factors For Respirators We have several comments on the draft appendix, which lists assigned protection factors for different types of respirators. Specifically, 3M is concerned that:

1) NRC needs to update the draft APF table to reflect the changes in NIOSH's respirator certification criteria found in 42 CFR 84;

2) by assigning a protection factor of 1 to several types of respirators in the draft APF table, NRC appears to be implementing a policy against the use of these types of respirators in nuclear facilities. Not only is such a policy unfairly damaging to manufacturers' products and misleading to end users, it also is not supported by technical studies., The policy of precluding the use of certain respirators by assigning them a protection factor of 1 is not justifiable and should be changed;

3) for one type of half mask respirator, the "single use disposable" respirator, the draft NRC documents not only assign a protection factor of 1, they also assert that fit checking these products is not possible. The draft also states that NRC does not believe medical evaluations are necessary for workers who use these products. 3M believes that these

provisions are factually wrong and should be eliminated. As is documented in the ANSI standard, an APF of 10 is the appropriate designation for "single use disposable" respirators, and the NRC assertions regarding fit testing and medical evaluation for users of these products are mistaken.

NIOSH Certification of Filters Under 42 CFR Part 84 When it published 42 CFR 84 on November 15, 1994, NIOSH changed the certification criteria for particulate filters. According to NIOSHs final rule, filters certified under 30 CFR 11 will no longer be available for sale or distribution after July 10, 1998. There is no one-to-one correspondence, however, between the 30 CFR 11 and the 42 CFR 84 filters.

As a result, NRC needs to provide guidance on which 42 CFR 84-certified filters will be acceptable for use in relevant exposures.

Nine new classes of filters are certified under 42 CFR 84. The new filter classification system establishes three filter efficiency levels and three categories of resistance to oil.

The three efficiency levels (95%, 99%, and 99.97%, i.e. 100%) reflect the ability of the filter to protect against airborne particulates. Every respirator submitted to NIOSH must provide at least that level of protection for which they are seeking certification while at least 200 mg oftest agent is loaded onto the filter. Filter efficiency is measured continuously and filter penetration must never exceed the established threshold.

Two types of challenge aerosol are used, either a relatively non-degrading particle, sodium chloride, or a degrading oil, dioctylphthalate (DOP). Filter degradation is defined as a decrease in filter efficiency that may occur as more test aerosol is loaded onto the filter. In some way, the aerosol changes or interferes with the way particles are trapped by the filter.

The three levels of resistance to the test agents are categorized as "N", "R" and "P." "N" series filters, which are tested against the sodium chloride aerosol, may only be used as protection against solids, water based liquids or other non-oil liquids.

"R" and "P" series filters, which are tested against DOP, are recognized as highly resistant to oil and considered appropriate for protection against all workplace aerosols. "R" series filters are tested up to 200 mg of loading. No information is available about their continued effectiveness beyond this point. As a result, use of "R" filters is limited to a single shift or an estimated 200 mg loading. These filters must be replaced sooner, however, in the event of damage to the filter or an excessive increase in breathing resistance.

"P" series filters are tested until the filter efficiency is stable or increasing. The minimum loading is 200 mg, but testing continues beyond this level. In a recently released users notice, NIOSH indicated that "P" series filters should be replaced according to schedules recommended by individual manufacturers.

2

In developing the test criteria, NIOSH adjusted several of the variables to approximate worst case conditions. The worst-case conditions selected were a mass mean aerodynamic diameter particle of about 0.3 µm, an air flow rate of 85 1pm, a neutralized test aerosol and, for "N" series filters, preconditioning at 85% relative humidity and 38°C for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> immediately prior to testing. Exposures in the vast majority of workplaces will have larger particles and lower breathing rates. Thus, in any workplace it is expected that the actual filter efficiency will be greater than the tested filter efficiency.

There are two factors involved in the selection of respirators certified under 42 CPR 84.

The first is a determination of whether an oil is present in the workplace. If no oil is present, employers can select "N" series respirators. If an oil is present, employers must select either an "R" series or "P" series respirator.

Next, employers must decide on the appropriate filter efficiency. When making this determination, employers should consider overall filter effectiveness. Even though a I 00% filter may have a higher tested efficiency than a 95% filter, in most workplaces you would not be able to detect any difference in actual performance between the two filters.

This is true for two reasons.

First, while the 42 CPR 84 test conditions are based on hypothetical worst case exposures, most exposures are not worst case. The larger particle sizes and lower breathing rates typically found in the workplace result in increased filter efficiency. A 95% filter will be essentially I 00% efficient in the workplace. Second, higher filter efficiencies can increase breathing resistance, which in turn can result in an increase in faceseal leakage. As a result, there is likely to be no observable difference in performance among the three levels of filter efficiency when they are used.

To achieve the desired level of protection, therefore, employers need not select a filter with an efficiency greater than 95% for a half mask respirator (APP= 10). Any NIOSH-certified half mask respirator will achieve this level of protection, regardless of the filter selected. Likewise, a 95% filter is acceptable for use with a full facepiece respirator (APP

= 50), which will provide the desired level of protection with any NIOSH-certified filter.

The NRC draft should be revised to reflect the changes in respirator certification implemented by NIOSH in 42 CPR 84 and to provide guidance to end users on the appropriate respirators for use in relevant exposures.

Assigned Protection Factor Of One In the draft APP table, NRC assigns a protection factor of I to several types of respirators used against airborne particulate hazards. Of the air purifying respirators, "single use disposables" are assigned the APP of I. Similarly, both halfmask and full facepiece 3

atmosphere supplying respirators operated in the demand mode are assigned this minimal protection factor.

Disposable HalfMask Respirators There is no basis for separating half mask respirators into two classes. Nevertheless, NRC's draft APF table assigns a protection factor of 10 to "half masks" and an APF of 1 to "single use disposables." NIOSH tests and certifies half masks and their filters, and NIOSH approves half masks as a single class. The tests a half mask respirator must pass to be NIOSH-certified do not vary within the class. Thus, NIOSH implicitly recognizes the fact that all half masks form a single class of respirator.

Before making a distinction between these two respirator types, therefore, NRC should first demonstrate that a real, quantifiable difference exists. There are few areas of performance on which the agency could base such a distinction. In fact, there are no data showing that the performance of "single use disposables" and other half mask respirators differs during use. Leakage into any half mask respirator can occur as a result of filter penetration, face seal leakage or defective valves or other parts. There is no data supporting the position that "single use disposables" are more susceptible to such breakdowns in performance.

As discussed above, filter efficiency should not be an issue since all filters for half masks must pass the same test criteria. Defects also should not be a basis on which to differentiate among half mask respirators. All respirators must be maintained according to the manufacturer's instructions, which should limit the occurrence of defects. In fact, some "single use disposable" respirators do not have any potentially defective parts, such as valves, connectors or detachable parts.

To avoid the problems of face seal leakage, fit tests are used to select the appropriate respirator for a specific person to use. OSHA permits the use of both qualitative and quantitative fit tests to determine the best fit for an individual face. Neither OSHA nor ANSI distinguishes between these fit tests regarding their ability to identify an adequate fit. The initial assessment of fit as determined by fit testing, therefore, is not an issue in evaluating subsequent performance.

Similarly, there is no validity to claims that a "single use disposable" respirator may not fit as well during use or that the fit achieved during the fit test may not be as easily reproduced as it would be for other half masks. If this were the case, it would be possible to look at the performance of these respirators in the workplace and find differences.

However, a 1995 study that examined the performance of different half mask respirators did not find a statistically significant difference in performance. 1 1

Nelson T.J.: The Assigned Protection Factor of Ten for Half Mask Respirators, American Industrial Hygiene Association Journal 56(7) 717-724 (1995).

4

For all of the reasons given above, therefore, there is no logical or scientific basis for separating "single use disposables" from other half mask respirators. NRC should eliminate this distinction in the final draft and assign all half mask respirators a protection factor of 10.

Atmosphere Supplying Respirators As with "single use disposable" respirators, there is no logical or scientific basis for assigning a negligible protection factor to half mask and full facepiece atmosphere supplying respirators operated in the demand mode.

Both half mask and full facepiece atmosphere supplying respirators function in the same manner as their air purifying counterparts. When negative pressure is created inside the facepiece by inhalation, air flows into the mask. The inhaled air is either purified by the cartridge, canister or filter, or is supplied from an independent source of air. In either situation, the air that reaches the wearer's lungs is pure. Because of this extreme similarity in function, there is no logical reason to assign different protection factors to similar air purifying and atmosphere supplying respirators.

Scientific Data Supports Higher APFs The low protection factors in the draft table do not accurately reflect the products' ability to filter airborne particles. A number of studies demonstrate that the APF of 10 is appropriate for "single use disposables. "2 OSHA and ANSI both accept that these products protect the wearer at exposure levels up to 10 times the PEL. If NRC arbitrarily assigns these products a different protection factor, employers familiar with the OSHA and ANSI values will likely be confused by the resulting inconsistencies. NRC may be attempting to implement a policy on acceptable and unacceptable respirators, but it would better serve the regulated community to state clearly that NRC does not approve of a particular type of respirator, rather than to assign a needlessly low protection factor.

Fit Checks And Medical Clearance In footnote "e" to the table, the draft states that it is not possible to perform an effective pre-use fit check on a "disposable" respirator. This statement is incorrect. To the contrary, there is research showing that following the manufacturer's instructions for fit checking produces acceptable results. As summarized by Myers3 :

Fit check methods applied to the DFF respirators were found to be equivalent_ to the fit check methods applied to the EF respirator by all criteria used in the study to assess fit checks. The sensitivity of 2

Ibid.

3 Myers, W.R., M. Jaraiedi, and L. Hendricks: Effectiveness of Fit Check Methods on Half Mask Respirators. Appl. Occup. Environ. Hyg. 10(11):934-942 (1995).

5

the fit check to detect bad donnings of previously fit tested respirators averaged 96% for all four respirators. Conversely, the percent of subjects accurately identifying properly donned respirators with the fit check averaged 66% for all four respirators.

Considering that fit check methods are very simple to perform and require no ancillary equipment, the sensitivity and specificity for these methods are remarkably good. 4 The draft also implies that medical screening is not required for the use of "disposable" respirators. We disagree. Each respirator wearer needs to be evaluated under the supervision of a physician to determine their fitness to wear a respirator.

In the draft Regulatory Guide 8 .15 on page 11 similar statements are made regarding the fit testing, fit checking and medical evaluations needed to use this type of respirator. As explained above, we believe the guide is in error and should be revised.

4 DFF refers to disposable filtering facepiece respirators, EF refers to elastomeric facepiece respirators.

6

3M Occupational Health and 3M Center, Building 260-3B-09 Environmental Safety Division St. Paul, MN 55144-1000 3IVI September 8, 1997 Dr. Donald A. Cool Director, Industrial and Medical Nuclear Safety Division Nuclear Regulatory Commission Mail Stop - 2 White Flint 8F5 11545 Rockville Pike Rockville, MD 20852-2738

Dear Dr. Cool:

On behalf of the Minnesota Mining & Manufacturing Company's (3M) Occupational Health & Environmental Safety Division, I would like to address an issue of particular concern to 3M regarding a pending notice of proposed rulemaking from the Nuclear Regulatory Commission (NRC).

We have learned that NRC is nearing completion of proposed revisions to its standard on respiratory protection for workers at nuclear facilities. As with the rule's counterpart for general industry that is under revision at the Occupational Safety and Health Administration (OSHA), the assigning of protection factors to half mask air-purifying respirators is likely to be among its more controversial provisions.

Based on recent conversations with staff at NRC, however, it appears the proposed rule as currently drafted would deviate significantly from the current consensus on protection factors. The state of the art on protection factors is found in ANSI 288.2-1992, the American National Standard for Respiratory Protection, which represents a consensus reached by experts in the field representing organized labor, industry, the federal government and respirator manufacturers:

For the reasons outlined below, we ask that you revise the protection factors assigned in the draft before issuing the proposed rule.

Earlier Comments 3M submitted detailed recommendations to NRC's Office of Research in June, prior to completion of the draft proposed rule. In those comments, we outlined several

Dr. Donald A. Cool Page Two September 8, 1997 concerns we had with an early draft of the rule and offered several peer-reviewed studies as support for our recommendations. In particular, we noted that:

• NRC needs to revise its terminology to reflect the changes in respirator certification criteria found in 42 CFR 84;

• there is no scientific justification for assigning a protection factor of one to NIOSH-approved, filtering facepiece half mask respirators (referred to as single use disposable respirators in the proposed rule), which would be unfairly damaging to manufacturers' products and misleading to end users; and

• the proposed rule is incorrect in asserting that "single use disposable" half mask respirators cannot be properly fit checked.

A copy of these earlier comments is enclosed.

Half Mask Respirators Traditionally, half mask negative pressure air-purifying respirators have been separated into two broad categories: disposable and reusable. All half mask respirators have a facepiece that goes over the user's nose and under their chin.

Filtering facepiece half mask respirators are constructed of a material that filters harmful airborne particulates from air inhaled through the facepiece. These respirators are referred to as disposable respirators.

Reusable respirators generally consist of a facepiece that is built of plastic or rubber, with an elastomeric edge designed to enhance the seal against the face and replaceable filter cartridges that are screwed into the facepiece. Some disposable respirators are made of similarly-constructed facepieces but have permanently attached filters and are designed to be discarded at the end of their service life.

While it used to be easy to distinguish between these two types of half mask respirators, design improvements and technological advancements have blurred the line between them. In both filter technology and facepiece design, 3M has led the industry in advancing respirator technology. Several of 3M's disposable filtering facepiece respirators, for instance, now incorporate an elastomeric face-to-facepiece seal. The existence of an elastomeric seal, however, is not essential to the proper functioning of a disposable half mask respirator.

Dr. Donald A. Cool Page Three September 8, 1997 Modem respirator technology enables 3M to produce highly efficient disposable and reusable products. 3M's disposable products, in particular, are able to protect wearers while providing a considerable cost-savings to employers. These products also are significantly lighter, more comfortable and easier to breathe through than reusable respirators. This design aspect reduces the likelihood that wearers will remove the respirator in hazardous environments because of excessive heat or discomfort, which otherwise would significantly increase worker exposure. Heavy, uncomfortable reusable respirators, on the other hand, increase the likelihood of an interruption in respiratory protection. 3M believes this is an extremely important factor that should be taken into consideration when establishing regulations governing the use of respirators.

Assigned Protection Factors Protection factors are assigned to classes of respirators based on their overall ability to protect the wearer. An assigned protection factor (APF) is primarily a function of filter efficiency, the integrity of the face-to-facepiece seal and comfort and breathability. In the past, OSHA has referenced the APFs in ANSI Z88.2 in compliance directives and other documents. This voluntary consensus standard, which was updated in 1992, assigns a protection factor of ten to all half mask respirators based on actual workplace data. This data was cited in the Nelson paper referenced in our earlier comments. A review of Nelson's conclusions will clarify the science supporting the decisions of the ANSI committee.

OSHA' s pending final respiratory protection rule is not expected to revise the currently accepted APFs, but will likely reserve the right to insert an APF table that will be developed in a subsequent rulemaking. In the interim, OSHA is expected to reference the protection factors in ANSI Z8 8.2-1992.

Proposed Rule Our understanding is that NRC's proposed rule will differentiate within the class of half mask respirators. Specifically, the proposed NRC approach as drafted assigns a protection factor often to those filtering facepiece half mask respirators equipped with adjustable straps and an elastomeric face-to-facepiece seal. All other filtering facepiece respirators would be assigned a protection factor of one.

To assign such a low protection factor to a NIOSH-approved respirator would render it useless: a protection factor of one is the same as no protection factor at all. The

Dr. Donald A. Cool Page Four September 8, 1997 protection factor of one assigned in the draft effectively bans the use of certain products. Although the direct impact of this decision would not be excessive at nuclear facilities, we are particularly concerned about the policy implications behind the decision and the potential repercussions of this decision as a federal precedent.

Such a distinction among disposable half mask respirators represents a flawed policy decision. Furthermore, unlike the protection factors established in ANSI 288.2-1992, this decision is not justified by any scientific research. In fact, NRC staff concede that the proposed rule offers no scientific support for its arbitrary distinction.

Several published, peer-reviewed studies, on the other hand, demonstrate that disposable and reusable respirators afford wearers similar levels of protection against airborne particulate hazards. These studies were referenced in and submitted with 3M' s earlier comments. Each of these studies is based on research performed on disposable respirators that lack an elastomeric face-to-facepiece seal.

While we were assured by NRC staff that this information was considered, it is not reflected in the draft proposed rule. The rule reaches a conclusion that is contradicted by the documented research 3M submitted, and no scientifically valid information is offered to support the seemingly arbitrary distinction made in the proposed rule. This is a significant issue that could draw a great deal of negative attention to NRC's rulemaking.

Impact of Proposed Rule If NRC was to issue a rule distinguishing between disposable and reusable half mask respirators, manufacturers of disposable respirators would be unfairly and significantly damaged. This also would be confusing to end users. The release of even a proposed rule that separates disposable and reusable half mask products could have a significant impact on the market, not just at nuclear facilities but at many other industrial facilities as well. Many 3M customers make purchasing decisions on the basis of proposed rules.

In addition to having an unjustified negative effect on end users, the rule as proposed would create a confusing and arbitrary distinction in the way two different federal agencies treat the same products. While NRC need not defer to OSHA when establishing respirator selection and use regulations, it seems logical to look to the precedent established by the agency charged with jurisdiction over the nation's workplaces. In the absence of an overriding need to differ from OSHA on such basic matters as assigning protection factors-and no such need has been demonstrated in

J ' * "I Dr. Donald A. Cool Page Five September 8, 1997 the proposal-NRC should not create unnecessary confusion by introducing an APF scheme that is inconsistent with OSHA's.

In addition to the logic supporting adoption or incorporation of the assigned protection factors in the ANSI voluntary consensus standard, White House Office of Management and Budget (0MB) Circular A-119 requires federal agencies to follow existing voluntary consensus standards when adopting those standards would achieve the purpose of the agency rulemaking and eliminate unnecessary and redundant uses of agency resources. Clearly, adoption of the consensus-based APFs in ANSI 288.2-1992 would satisfy the 0MB directive.

Conclusion For these reasons, 3M urges NRC to maintain the existing classification of half mask respirators as a single category. This is a generally accepted practice adhered to by both OSHA and ANSI. For NRC to do otherwise would trigger an adverse impact on 3M and other respirator manufacturers based on an arbitrary new policy with no scientific support and an unjustified dismissal of peer-reviewed evidence that supports grouping these product designs together. Because of similarities in faceseal design that effectively create a continuum of products, it also would create enormous problems for those trying to distinguish between disposable and reusable products.

3M hopes that you will reconsider the policy decisions that went into drafting the propose rule as it currently exists, and we would be willing to offer any technical or other assistance you desire.

We appreciate your consideration of these comments.

Sincerely,

{Pf.';)4 Ronald E. King Regulatory Affairs Manager 3M Occupational Health & Environmental Safety Division REK:llb/15 Enclosure

LAO consulting, Inc. DOCKETED Industrial Hygiene

'J NRC 1855 west aueens ct.

Crofton, MD 21114 "98 SEP 16 P3 :12 410-721-3468 September 14, 1998 OFf--i.

R . . l, AO_', J Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555--0001 Attn: Rulemakings and Adjudications Staff

Dear Sir or Madam:

This is in response to the NRC request for comments to the proposed rule on Respiratory Protection and Controls to Restrict Internal Exposures. 10 CFR Part 20. The following comments are related to the fit testing and the assigned protection factor:

1. The equivalency between elastomeric and filtering facepieces The footnote f of Appendix A to Part 20 states that "no distinction is made in this Appendix between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Both types are acceptable so long as the filter medium is at least 99% efficient and all other requirements of this part are met."

It appears that NRC considers that a filtering facepiece (disposable respirator) can provide the same protection as an elastomeric facepiece provided that the filtering facepiece has sea ling area enhancing material and adjustable head straps. There is no assurance that a filtering facepiece meeting these design specifications would provide the same degree of protection as a respirator equipped with an elastomeric facepiece. The only method to ensure their equivalency is to compare the results of quantitative fit testir,g (QNFT) performed en each type of resplrator. NRC should only give credit for the use of a filtering facepiece when it provides the same fit factor as the elastomeric facepiece (more in the next paragraph). NRC should also clarify that the 99% efficient filter medium means a NIOSH approved P--99 or P-100 series particulate filter.

2. Minimum passing fit factor NRC requires that in order for a half-mask respirator to receive an APF of 10, the wearer must achieve a minimum fit factor of 100. The value of 100 is a product of the protection factor of 1O and a safety factor of 10. The PF of 10 is based on the quantitative fit testing (QNFT) study conducted by Edwin Hyatt of the Los Alamos Scientific Laboratory (LASL) in the early seventies 1

• Hyatt selected a variety of half-masks for his study. Protection factors (PF) were measured on the 25 member anthropometric test panel with facial characteristics that represents the American work E 24~

I I N TAFF

population. The test results indicate that a properly trained and fitted wearer can obtain an average efficiency of 90%, which corresponds to a PF of 10. All tested respirators had only one size and none of these masks is available today. The term "protection factor" has been changed to "fit factor" in the current respiratory protection standards.

Warren Myers of the University of West Virginia has conducted a QNFT study for the Mine Safety Appliances Company (MSA) on commonly used half-mask elastomeric facepiece respirators 2

• Facepieces manufactured by Aerro, MSA, North, Survivair, 3M, and Willson were selected for testing. MSA has submitted the study report to the OSHA respiratory protection docket. A total of 13 facepieces was tested. Each mask has three sizes. Fit factors were measured on a 25-member test panel. Test subjects both male and female were selected to fit the facial characteristics of the Los Alamos half-mask anthropometric test panel. The fit tests were performed on the TSI Portacount. The test results are shown on Table 1. The results indicated that fit factors varied between 100 and 81,300. The geometric mean of each mask varied between 1,400 and 6,600.

The fifth percentile fit factor varied from 100 to 1,150. This study would be representative for the half-masks available today.

The currently available half-masks are made of very pliable silicone rubber that would achieve a much higher fit factor than the facepieces used in the Hyatt study. It is very common to achieve fit factors more than 1,000. The Myers study indicates that respirator A-2 has the lowest fifth percentile value of 100 and respirator C-3 has the highest fifth percentile value of 1,150.

Many professionals in the respirator community have criticized the low passing factor of 100 which permits a poor fitting facepiece to be used. However, the Myers study is the only study that compares the fit tested results of various currently available elastomeric facepieces. The current NIOSH respirator testing and certification regulation, 42 CFR 84, has no fit testing requirement for respirator certification. The current passing fit factor of 10 for the half-mask respirator is based on the test results of respirators that are no longer available. The passing fit factor derived from the currently available half-mask respirators should be used for assigning the minimum passing fit factor. To ensure that approved respirators would provide adequate fit, NRC should require a minimum passing fit factor base on the currently available information. There are two approaches in assigning the minimum passing fit factor. The first one is to require a minimum fit factor of 1,000 which is based on the lowest fifth percentile fit factor of 100 and a safety factor of 10. The second approach is to require that QNFT be performed on a given respirator. If the respirator achieves a fifth percentile fit factor of 100 on the Los Alamos 25 subject anthropometric test panel, it can be assigned a protection factor of 10. NRC should require a minimum passing fit factor of 1,000 for a half-mask and a minimum fit factor of 5,000 for a full facepiece.

3. Facepiece seal check To ensure that a respirator would provide adequate protection during use, a user seal check must be performed after donning. A satisfactory method to ensure adequate facepiece to face seal is to perform a negative pressure and a positive pressure seal check. These two seal check methods can be performed easily on elastomeric facepieces. Since most filtering facepieces have no inhalation or exhalation valve, or have an inaccessible exhalation valve, it is difficult or impossible to perform these two seal check methods on the filtering facepieces. Many filtering facepiece manufacturers recommend a 3M developed "positive pressure fit check" (PPFC) that requires the respirator wearer 2

to cup both hands over the filter area of the filtering facepiece and inhale. The purpose of a negative pressure fit check test is to block the inhalation area, which is easily performed by blocking the air vents of the filter cartridges on an elastomeric facepiece. The disposable respirator manufacturers' recommended method cannot block all the filter area of the respirator. It is not clear what this test accomplishes. Unfortunately, the ANSI Z88.2-1992 respiratory protection standard accepts any manufacturer's recommended fit check method.

The Occupational Safety and Health Administration (OSHA) has reviewed the validation data of the PPFC method submitted by 3M3, and wh ich claims that filtering facepieces can be effectively fit checked to allow for a protection factor of 10. A total of 23 subjects was tested in several trials to see how many of those who failed a QNFT would also fail a positive pressure fit check (PPFC) procedure performed by 3M. Using a QNFT screen level of 1008, as many as 37 per 100 improperly-fitted wearers of 3M's 8710 respirator could be erroneously passed by 3M's PPFC procedures. If a QNFT screening level of 10 is selected, as many as 41 per 100 improperly-fitted wearers of 3M's filtering facepiece could be erroneously passed by 3tv','s PPFC procedures.

NIOSH has deleted the fit testing and user seal check requirements for respirator certification. To ensure adequate wearer protection, NRC should require the use of an effective user seal check method that results in a minimum number of inadequate fits.

4. Qualitative fit testing methods There are three qualitative fit testing (QLFT) methods available: isoamyl acetate, irritant smoke and sodium saccharin. Based on information in the OSHA Docket H-049A, the mass medium aerodynamic diameter (MMAD) of sodium saccharin is between 3 and 5 micrometers. The faceseal leakage studies conducted by Hinds of the University of California at Los Angels and Willeke of the University of Cincinnati indicate that particles larger than one micrometer are less likely to challenge the faceseal of a respirator. NRC should not adopt any QLFT method in which the challenge agent does not penetrate the faceseal.

NRC should also specify the detailed protoco l regarding the performance of the QNFT. Parameters such as the maximum particle diameter (geometric mean and standard deviation), exercise regimen, exercise time, etc., should also be specified by NRC.

Since the radioactive particulates are highly toxic, a higher standard should be applied for worker protection. I wou ld like to thank you for the opportunity to comment and also to offer my assistance in deve loping the amended rule.

Sincerely, Ching-tsen Bien, PE, CIH 3

TABLE 1 FIT FACTORS OF ELASTOMERIC FACEPIECES Manufacturers: Aearo, MSA, North, Survivair, 3M, and Willson.

Respirator Fit Factor Geometric Geo. Std. Fifth% 95% Conf. Lower 95-95 Mean Deviation Value Limit on GM Tolerance Limit A-1 100- 3000 7.03 120 1350 - 6740 30 61000 A-2 100 - 1400 5.04 100 740 - 2800 40 20600 B-1 100 - 4700 3.95 490 2660 - 8270 200 44400 B-2 1000- 4800 2.58 1000 3230- 7070 540 35550 C-1 100 - 3200 2.94 540 2040- 4960 240 11500 C-2 200- 6000 3.36 810 3610 - 9830 370 42900 C-3 500- 6600 2.89 1150 4240 ~ 10170 580 29800 D-1 100 - 2800 3.07 440 1760 - 4430 210 19300 D-2 200- 4600 3.58 560 2700 - 7730 250 51100 E-1 100 - 3300 3.56 410 1970 - 5630 180 43400 E-2 300- 4600 3.72 530 2690 - 7960 230 41500 F-1 200- 2000 3.27 290 1250 - 3320 130 21500 F-2 100 - 5800 3.76 660 3360 - 10010 280 81300 4

REFERENCES

1. Hyatt, EC: Respirator Protection Factors. Los Alamos Scientific Laboratory, UC-41 (1976).

2. Myers, WR: Fit Test Quality Assurance Report for MSA on Half Facepiece Respirators: Phase II Report. Prepared for MSA Co., March 1993

3. Letter from Patrick Tyson, Acting Assistant Secretary for OSHA to Peter G. Nash, Counsel for 3M. April 15, 1986, OSHA Docket H-033.

5

BWX Technologies, Inc.

Babcock & Wilcox, a McDermott company DOCKETED Naval Nuclear Fuel Division USHRC P.O. Box 785 Lynchburg, VA 24505-0785 (804) 522-6000 "98 SEP 15 A8 :46 September 10, 1998 98-090 DOCKET Nv,.,~R .,~

Secretary AITN: Rulemakings and Adjudications Staff PROPOSED RULE <<0 (f>3F(( 3'i51/

U.S. Nuclear Regulatory Commission Wa~hington, DC 20555-0001 Gentlemen:

BWX Technologies, Inc., Naval Nuclear Fuel Division, submits the following comment regarding the proposed revision of 10 CPR 20, that was published in the Federal Register of July 17, 1998, Vol. 63, No. 137, page 38511.

BWX Technologies, Inc. (BWXT) requests NRC to add provisions for the allowance of combination full facepiece pressure demand supplied air respirators (SAR) with auxiliary self-contained air supply to Appendix A, 10 CPR 20, fpr use during emergency entry into an unassessed environment.

BWXT believes the addition of this type of apparatus is justified by the following:

1. The National Institute of Occupational Safety & Health (NIOSH) has provisions for approving the reference SAR for emergency entry into hazardous environments. 42 CPR

84. 70 states:

(b) The following respirators may be classified as designed and approved for use during emergency entry into a hazardous atmosphere:

(1) A combination respirator which includes a self-contained breathing apparatus; and (2) A Type "C" or Type "CE" supplied air respirator, where-(i) The self-contained breathing apparatus is classified for 3, 5, or 10 minute service time and the air line supply is used during entry; or (ii) The self-contained breathing apparatus is classified for 15 minutes or longer service time and not more than 20 percent of the rated capacity of the air supply is used during entry.

SEP 2 4 1998 Acknowledged by

U.S. NUCLEAR REGM RULEMAKI GS & A OF~I f OF i: G

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U.S.N.R.C September 10, 1998

2. NIOSH's "Respirator Decision Logic" dated May 1987, tables 1,2, and 3 provide assigned protection factors (APF). Tables 1-3 each state the following for an APF of 10,000:

"Any self-contained respirator equipped with a full facepiece and operated in a pressure demand or other positive pressure mode. "

"Any supplied-air respirator equipped with a full facepiece operated in a pressure demand or other positive pressure mode in combination with an auxiliary self-contained breathing apparatus operated in a pressure demand or other positive pressure mode.

3. OSHA has recognized the SAR is capable of providing the same level of protection as an SCBA in its recent revision to the general industry respiratory protection regulations. 29 CFR 1910.134(d)(2) "Selection of Respirators, Respirators for IDLH atmospheres" states:

(i) The employer shall provide the following respirators for employee use in IDLH atmospheres:

(A) A full facepiece pressure demand SCBA certified by NIOSH for minimum service life of thirty minutes, or (B) A combination full facepiece pressure demand supplied-air respirator SAR) with auxiliary self-contained air supply.

NIOSH and OSHA consider the combination full facepiece, pressure demand, supplied-air respirator, with auxiliary self-contained air supply, to provide a user with adequate protection for entry into environments where the contaminant or concentration is unknown. This type of respirator is widely used throughout the nuclear industry and its continued use should be authorized by NRC in Appendix A, 10 CFR 20.

Sincerely, Ame F. Olsen Licensing Officer

NISr UNITED STATES DEPARTMENT CF COMMERCE National lnatitute of Standards and Technology Ga,~ b I land 209 99 19 C ric 21.J Pi! I: 29 n!::lLJ'....' E~

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OPOSED R e:<o C") f'T1 Rules and Directives Branch Division of Admin istrative Services Office of Administration (t,3F~385/J -

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USNRC °'

Washington, D.C. 20555-0001

Reference:

63FR38511-21 (Proposed 10CF20.1701-5) and Draft Regulatory Guide DG-8022

Dear Sir:

Please accept the following comments on the proposed rule and regulatory guide pertaining to Respiratory Protection and Controls to Restrict Internal Exposure.

The NRC is to be commended on the many proposed simplifications to the rule, particularly those moving current portions of the ru le to the proposed regulatory guide.

However, the proposed rule and the interpretations reflected in the statements of consideration and the regulatory guide raise serious questions of excess and duplicate regulation . For the vast majority of licensees, internal exposure and airborne radioactive material source terms are small-to-trivial portions of worker exposure. The application of Subpart H and its attendant procedures and oversight is totally out of proportion to the related radiological benefits. This is the primary context for the following comments, i.e., licensees where internal exposures are less than 10% of the regu latory limits, and in most cases much less than these limits.

First let us emphasize that there is no question that OSHA ru les must be followed. The issues discussed below do not concern worker safety or effectiveness of the respiratory protection for the hazardous environment.

The primary issue is one of excess and duplicate regulation. Despite the NRC assertion that an OSHA respiratory protection program meets the requirements of the NRC ru les, the mere fact that 20.1703 states something beyond the phrase "comply with OSHA" creates a different program. And the fact of the matter is that organizations have different organizational elements to implement 10CFR and 29CFR. Hence the mere existence and forced applicability of th is rule creates different programs to achieve the same objective. This is a simple fact of life.

The rule is excessive because it is applied to situations where the radiological benefits are negligible or at best a secondary issue, even though the user is complying with the EP 2 998 cknowledged

lJ.S. NUCLEAR REGULATORY COMM! I RULEMAKINGS & ADJUDICATIONS St OFFICE OF THE SECRETARY OF THE COMMISSION

appropriate OSHA requirements. Prior published interpretations from NRC, e.g.,

regarding the implementation of the revised 10CFR20, made it clear that Subpart H applies regardless of the concentration level, no matter how small. In the proposed regulatory guide the sentence in section 3.1, i.e., "Unless the licensee can clearly show otherwise, any use of respirators is considered to be for the purpose of limiting intake of radioactive material," makes this point very explicitly.

These NRC interpretations and the statement in the proposed regulatory guide in fact seem contrary to the simple English in both the current and proposed 20.1703. That is, the phrase "if a licensee assigns or permits the use of respiratory equipment" is qualified by "to limit the intake of radioactive material." The straightforward reading of this is that if the licensee's basic purpose is not to limit the intake, then regardless of secondary benefits relating to this, this section would not apply. The NRC interpretation of the current rule with its added phrase "pursuant to section 1702" seems even more at variance with a simply reading of the sentence. We suggest that the current phrase in 20.1702 be retained and that the commonsense interpretation suggested above be used. This aspect of the rule, i.e., the intent to reinforce this interpretation by deleting the above phrase in 1703, is not adequately addressed in the Statement of Consideration and, because of its substantial impact on many licensees, deserves added notice from the NRC.

An open question not addressed by the NRC in the Statement of Consideration is the NRC choice not to simply require OSHA compliance of any respiratory usage. The current 20.1703 in fact is excess baggage in 10CFR since NRC and OSHA signed their agreement on joint enforcement of the respiratory (and other) OSHA rules. If 20.1703 contains elements that are essential for radiological applications for specific licensee usage situations (and this is not explicitly discussed in the statements of consideration) beyond what is in 29CFR, then 20.1703 should identify and restrict its applicability to those situations. To the extent that licensee respirator usage is no different from other non-radiological applications, NRC should simply require OSHA compliance.

And to extend the above argument, to the extent that respirator usage is to control exposures at levels less than 10% of the regulatory limits, NRC should simply require OSHA compliance. The simple fact is that this level of worker internal exposure (or some other arbitrarily lower level of the NRC's choosing) does not justify the administrative and worker resources necessary to administer a 20.1703 program, particularly for the mostly infrequent but appropriate usages of such devices.

In fact, the complexity and burden added by 20.1703 to meeting the basic OSHA requirement is detrimental to implementing ALARA for internal exposures. In the common situation where external exposures are absent or minimal and airborne concentrations are sufficiently low that engineering controls are not justified, 20.1703 in fact discourages any added ALARA measures via respiratory protection. It is not sufficient to simply comply with the OSHA performance requirements. One must also have license conditions detailing how this will be done, have implementing procedures, have quality assurance programs, make additional measurements and assessments,

have auditing programs, etc. While all this is justified for work in life threatening environments and for high dose rate situations, for most licensees it is an avoidable burden for work tasks in airborne atmospheres that are equivalent to at most a few mrem per hour. If NRC has made the judgement that use of respirators for ALARA purposes at such exposure levels is generically not justified, even when in compliance with OSHA requirements, then this should be so stated. Otherwise NRC should allow simple OSHA compliance with no further approval needed from NRC for such situations.

Specific comment follow on various portions of the proposed rule and on the draft regulatory guide titled Acceptable Programs for Respiratory Protection.

1. 20.1703(b) requires specific application for non-certified respirators with evidence of the needed pmtection factor. Since the proposed rule is being applied to situations where the licensee needs no protection factor this section should exempt such licensees from needing NRC approval. Only OSHA issues regarding such usage should be a concern.

2. 20.1703(c)(1) and (2) require certain surveys, bioassays, and measurements simply because a respirator is used and not because other relevant portions of 10CFR20 require these measurements. NRC should clarify that these are not required unless other sections of 10CFR20 so require them . For example, if the airborne radioactivity levels are 1% of DAC there is no requirement for bioassays, personal air sampling, exposure records, etc. And mere use of a respirator should not precipitate such a requirement.

3. 20.1703(c)(3) requires fit testing, but if no credit is being taken for a protection factor because the working atmosphere is less than 1 DAC, this should not be an issue with NRC. Other non-radiological reasons for such usage of a respirator should only be an OSHA issue.

4. 20.1703(d) should be stronger. Since no radiological work would be in an airborne concentration sufficiently high to represent an immediate risk to life, the user should be advised that a respirator can be immediately removed in any situation where the user judges that his health is at risk. Presumably, adequate health screening would minimize the possibility of such a situation arising, but NRC should acknowledge that the radiological risks of such an exposure are unlikely to justify continuing respirator use in a high-stress situation.

5. Regarding 20.1703(i), these statements would appear to be self-evident given the requirements of 10CFR20.1204. There is no discussion in the Statement of Consideration identifying the ambiguity that necessitates this section. If there is some situation envisioned by NRC that is not adequately addressed in 20.1204, then it should be identified. Otherwise it is suggested that this be moved to a footnote in the proposed regulatory guide.

6. The Statements of Consideration states, "All licensees who possess radioactive material in a form that requires a respiratory protection program are identified during the license application, amendment, or renewal process." This is used to justify the useful elimination of the notification requirement. But unless this is simply referring to self-identification by the license applicant, this seems to refer to some sort of an NRC classification criterion that is not elsewhere discussed in this proposal. If the result of this criterion is to expand coverage of Subpart H to more licensees, this should be explicitly discussed and those licensees should be alerted to comment on this proposed rule.

The following comments are on the draft regulatory guide titled Acceptable Programs for Respiratory Protection.

1. In section B it is stated that "If a respiratory protection device is assigned or permitted to be used, the device is considered by the NRC as being used to limit intakes of airborne radioactive materials unless the device is clearly and exclusively used for protection against nonradiological hazards. Whether or not credit it taken for the use of the device to reduce intake and dose, Section 20.1703 would apply .... "

To repeat what was previously stated, we submit that this is needless, duplicate regulatory coverage. Subpart H is clearly and explicitly targeted to controlling exposures at levels greater than 1 DAC, and sections 1703-4 are intended for situations where respirators are needed to lower internal exposures. Most research reactor facilities have airborne radioactive material at some low level, almost universally at a trivial level (e.g.,

<1 o-s DAC), but this proposal mandates section 1703 coverage for any industrial usage of a respirator, regardless of the fact that such usage is controlled by OSHA rules and that the radiological exposure reductions are minimal. This requirement is made even more redundant by the fact that NRC has an agreement to enforce OSHA rules, and hence presumably does not need section 1703 to control improper use of respirators, and by the fact that exposures at such concentrations are a diminishingly small fraction of the facility TEDE. We suggest that this guide clarify that Subpart H is only explicitly invoked for concentrations that are likely to produce exposures greater than 10% of the limits, and that at levels below this, all that is required is an OSHA compliant program.

Similarly, the wording in section 3.1 ("Unless the licensee can clearly show otherwise, any use of respirators is considered to be for the purpose of limiting intake of radioactive material.") mandates this duplicative regulatory coverage.

We would like to emphasize that duplicate regulatory coverage like this, no matter how similar the rules, is not free. Both human and dollar resources are expended that could profitably be used elsewhere.

2. The discussion of ALARA in section C.2 is excellent and should be retained.

3. The sentence in section 3.1, i.e., "Unless the licensee can clearly show otherwise, any use of respirators is considered to be for the purpose of limiting intake of

radioactive material," is refreshingly honest. The licensee is guilty unless he can prove beyond doubt that he is innocent. However, it would seem more in keeping with an effective regulatory program to assert that the NRC should have to demonstrate that the usage in question was primarily for radiological protection purposes or necessary to meet ALARA objectives. A licensee should not be required to perform surveys that are not otherwise required just to prove his 'innocence.' Nor should a licensee have to avoid doing surveys for fear of invoking 20.1703 because of the possibility of demonstrating the presence of trivial levels of airborne radioactive material. As indicated by section 3.2 there are no halfway measures. Either you have a full-blown, documented 1703 program suitable for any level of respirator usage or you have none.

4. Section 3.3 is mathematically questionable. If the airborne concentration is less than 0.1 DAC, then the APF could be zero and the provisions of 20.1502 would permit the

'no record' allowance. But this zero would not meet the section 3.3 ratio requirement.

Also it would seem that the absence of a factor of 10 in section 3.3 in order to meet the 20.1502 10% requirement implies the reasonable presumption that respirator usage is less than 10% of a work year. But should not this presumption be mentioned? More likely there is simply something in this section that we do not understand, in which case added discussion would be useful.

Sincerely, WJ§!.J/

Lester A. Slaback, Jr. C.H.P.

NIST Gaithersburg MD 20899 cor:nrc-rg8022

IEM Integrated Environmental Management, oocKET£0 Inc. US C 9040 Executive Park Drive, Suite 205 Knoxville, TN 37923 Phone: (423) 531-9140 Cf)

/

Fax: (423) 531-9130 1680 East Gude Drive, Suite 305 Rockville, MD 20850 Phone: (301) 762-0502 August 17, 1998 Fax: (301) 762-0638 OFF - http://www.iem-inc.com R\.)l 1-Af) J'v '

Secretary U. S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff

Subject:

Integrated Environmental Management, Inc.; Maryland Department of the Environment License No. MD-31-281-01; Comments on "Respiratory Protection and Controls to Restrict Internal Exposures", 10 CPR Part 20.

Reference:

Federal Register, 63 FR 38511, July 17, 1998, Proposed Rule.

Integrated Environmental Management, Inc. (IEM) is licensed by the Maryland Department of the Environment (MDE), a U. S. Nuclear Regulatory Commission (USNRC) Agreement State. In addition, IEM is a small business that meets the USNRC's size standards in 10 CFR 2.810. Based on our review of the referenced proposed rule, we have concluded that, if implemented in its present form, the proposed revi$'ion to 10 CFR 20, Subpart H, "Respiratory Protection and Controls to Restrict Internal Exposures", would have potentially negative ramifications from both a compliance standpoint as an Agreement State licensee, and from a business standpoint. The purpose of this letter is to provide IEM' s comments on those aspects (delineated below) of the proposed rule that are of concern to us .

• Operability Testing In §20. l 703(c)(3), there is a requirement that respirators be tested for operability (e.g., fit check, functional tests) prior to each use. Such tests are typically not documented, and there is no quantitative means of determining whether the respirator "passed the test" or not. Therefore, licensees will be unable to demonstrate compliance with this requirement. On the other hand,

§20.1703(c)(4) already requires that operability tests be included in written procedures, rendering the specific requirement of §20. l 703(c)(3) moot.

Bioassays Certain chemical and physical forms of the heavy elements (i.e., W- and Y-class forms of thorium, and Y-class forms of uranium and some transuranics) are relatively insoluble in body fluids. In addition, conventional bioassay methods (i.e., whole body and organ counting, urine bioassay, and fecal bioassay) are not sensitive enough for routine exposure monitoring for these elements. Under these circumstances, the only option open to a licensee is to sample the air in the breathing zone of the worker, and then make assumptions about intake rates, patterns, and metabolism in order to estimate the worker's dose of record.

In spite of these circumstances, section 20.1703(c)(2) of the proposed rule requires the use of bioassays during respirator use in order to evaluate actual intakes. Such a requirement places an AUG 2 7 1998 Acknowledged by card"-*"""'".... .. .....

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Docwnent Statistics

undue burden on licensees who work with the aforementioned materials. They would be either unable to comply with the regulation, or forced to implement a bioassay program that, because of inadequate sensitivity, is unable to provide any useful data. It may, in fact, place the licensee in a perpetual state of noncompliance since minimum detectible activities are larger than the annual limit on intake (ALI).

Permitted but Unassigned Uses of Respiratory Protection Under certain circumstances, a licensee may evaluate a work enviromnent for its potential radiological hazards and make a determination that neither individual exposure monitoring nor respirators are necessary for dose control purposes. However, employees in those environments may choose, for reasons of their own, to wear respirators anyway. (IEM does not preclude the use of respirators by its employees or subcontractors.) Under the proposed regulations, the simple act of providing a respirator to an employee upon request results in licensees having to establish a respiratory protection program pursuant to section 20.1703 of the proposed rule. The result is the unnecessary dedication of resources even though no dose of record will ever be recorded.

Disposable Respirators No Assigned Protection Factors (APFs) for disposable respirators are given in the proposed rule, thus no credit may be taken for their use even though their use is encouraged. 1 However. the programmatic requirements of §20.1703 are activated if any form of respiratory protection is required or permitted. OSHA requires employers to provide respiratory protection to employees if it is so requested. To accommodate this request by offering the use of disposable respirators, if the licensee does not have an approved respiratory protection program incorporated into its license, would subject the licensee co enforcement action unless a costly program is implemented.

Emergency Response If a licensee is authorized to possess, handle or use sealed sources only, its radiation protection program must still address response actions in the event of a breach in a source's integrity (e.g.,

detection of a leak, damage to the source, etc.). If a required response action might, under certain circumstances, involve respirator use or consideration for respirator use, the proposed rule implies that the licensee must maintain a respiratory protection program pursuant to 10 CFR 20. 1703. In other words, the proposed rule implies that all licensees incorporate a respiratory protection program into their lii:ense u11lcs:; it can be den1onstr3ted th::t rc~pi:-~tc:- usage 1.vil! never be ~\.:quired C\,'Cn under emergency considerations. This implication imposes an undue burden on licensees that deal with only non-dispersible radioactivity under the provisions of their license.

Recommendations In light of the aforementioned comments, IEM offers the following recommendations to the USNRC in regard to the proposed rule.

• The §20. l 703(c)(3) requirement that respirators be tested for operability prior to each use should be deleted.

1 63 FR 38515. July 17. 1998.

2

• Because conventional bioassay for certain radionuclides does not provide data useful for confirming the effectiveness of a respiratory protection program ,

and because the requirements in 10 CFR 1703 are costly and, under certain circumstances, provide no radiation protection benefit if no "credit" is taken for respirator use in the dose assessment process, section 20. l 703(c)(2) should be modified to read as follows (modification shown in italics) : "If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material, the licensee shall implement and maintain a respiratory protection program that includes surveys and bioassays, if appropriate and if protection factors are used for dose assessment, to evaluate actual intakes."

• The use of disposable respirators or any other form of respiratory protection that does not have an APF should be exempt from the requirements of 10 CFR 20 unless they are mandated by the licensee for control of radionuclide intakes and/or an appropriate airborne protection factor has been approved pursuant to 10 CFR 20. 1705.

The proposed rule should establish the extent to which emergency planning efforts must incorporate the programmatic requirements of 10 CFR 20. 1703 .

Thank you for the opportunity of submitting these comments and recommendations. We look forward to their favorable consideration, and to timely issue of the revised respiratory protection rules .

Sincerely,

~~

Carol D. Berger President

~JJht~~

Brian A. Kelly Chief Operations Officer cc : R. A. Duff (RSO)

Douglas McAbee - Maryland Department of the Environment Charles Hardin - Conference on Radiation Control Program Directors 3

°98 JUL 14 All :22 NUCLEAR REGULATORY COMMISSION on j _,

10 CFR Part 20 Aul ' ',

ADJU ~- . I,.. .

RIN 3150-AF81 Respiratory Protection and Controls to Restrict Internal Exposures

• AGENCY: Nuclear Regulatory Commission .

ACTION : Proposed rule .

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations regarding the use of respiratory protection and other controls to restrict internal exposure to radioactive material. The proposed amendments are intended to make these regulations more consistent with the philosophy of controlling the sum of internal and external radiation exposure, reflect current guidance on respiratory protection from the American National Standards Institute (ANSI), and make the requirements less prescriptive without reducing worker protection. The proposed amendments would provide greater assurance that worker exposures will be maintained as low as is reasonably achievable (ALARA) and that recent technological advances in respiratory protection equipment and procedures are reflected in NRC regulations and are thus clearly approved for use by licensees.

DATES: Submit comments by (Insert dat? 7~ ~a~/a1 lublication date). Comments received after this date will be considered if it is practical to do so, but the Comm ission is able to assure consideration only for comments received on or before this date.

ADDRESSES : Send comments to: Secretary, U.S. Nuclear Regulatory Commission, WashingtQ.n, _DC 20555-0001, Attention: Rulemakings and Adjudications Staff.

The NRC staff specifically requests comment on whether the technical aspects of the rule should be addressed through alternative approaches other than the proposed rule, such as a simple performance-based rule with-a Regulatory Guide endorsing ANSI standards to permit a more rapid regulatory resp_or:ise by t_he NRC to future technical developments and changes in industry consensus standards.

\ "'

In addition to comments on this proposed rul~, t~e NRC staff requests specific comments

' ~ ' -

, 1 \

• l and suggestions._regarding_the contenfand scope of a planned revision of NUREG-0041,

. . ' . t ' 1, *

• • "Manual of Respiratory; Pr-ot~ctioa..Against ~irborn~ Radioactive Materials."

Hand deliver,comments to : 11555 Rockville P,ike, Rockville , Maryland between 7:30 am and

. . ,. . \

4: 15 'pm-Fiedetal w~rkd~ys~ r ... 1 ... * *

. ~ .. '""

Yo~ may also provide comments via the'NRC's interactive rulemaking web site through the NRC home page (http://www.nrc.gov). This site provides the availability to upload comments as

/-.

~.,,;t:,;;_;. - ;j f3/4;les:.~~~i~~~~~)J.9JJ:_l:s~p~7E,~~

- *-* , **=-~- *' ,**J.-;. , - ..., ., ... * * .,. . * ,,* . ,: ,, .

fu~~f~:m. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-5905; e-mail CAG@nrc.gov.

Certain documents related to this rulemaking, including comments received and the environmental assessment and finding of no significant impact, and NUREG-0041, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking .

2

Single copies of the environmental assessment and finding of no significant impact and the regulatory analysis may be obtained from Antoinette Walker, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission , Washington, DC 20555, telephone:

(301) 415-1282.

Single copies of the draft revision of Regulatory Guide 8.15, "Acceptable Programs for Respiratory Protection," which is related to this rulemaking , may be obtained by writing to : U.S.

Nuclear Regulatory Commission, Printing and Graphics Branch, Washington , DC 20555-0001 ;

or by fax at (301) 415-5272.

FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear Reactor Regulation , U.S. Nuclear Regulatory Commission , Washington , DC 20555-0001 , telephone (301) 415-3883 ; email AKR@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background A major revision of 10 CFR Part 20, "Standards for Protection Against Radiation," was published on May 21, 1991 (56 FR 23360) . Although the NRC was aware that certain provisions of Subpart H and Appendix A to Part 20 were out of date and did not reflect new technology in respiratory devices and procedures, minimal changes were made because an ANSI standard was being prepared that was expected to provide state-of-the-art guidance on acceptable respiratory protection devices and procedures . The NRC decided to address further revisions to Subpart Hand Appendix A to Part 20 when the ANSI guidance was complete .

3

In response to public comments on the proposed 10 CFR Part 20, the NRC made several changes to Subpart H in the May 21 , 1991, rule to make it consistent with the new philosophy and science underlying the new Part 20. The new Subpart H required that the practice of ALARA apply to the sum of internal and external dose, permitted correction of both high and low initial intake estimates if subsequent, more accurate bioassay measurements gave different results, and clarified that a respiratory protection program consistent with Subpart H is required whenever respirators are used to limit intakes of radioactive material.

After 10 CFR Part 20 was revised, ANSI Z88.2-1992, "American National Standard for Res~::--3tory Protection" was approvc-,..l for publication by the American National Standards Institute. This document provides an authoritative consensus on major elements of an acceptable respiratory protection program, including guidance on respirator selection, training , fit testing, and assigned protection factors (APF). Consistent with the publication of ANSI Z88 .2-1992 the NRC is proposing these changes to Subpart H of Part 20 to make the regulations less prescriptive without reducing worker protection.

II. Summary of the Proposed Changes The Commission is proposing to amend § 20.1003, §§ 20.1701 through 20.1704 in Subpart H, "Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas," of 10 CFR Part 20, and Appendix A to Part 20, "Protection Factors for Respirators.

In § 20.1003, Definitions, definitions are proposed for Assigned protection factor (APF),

Disposable respirator, Fit check, Fit factor and Fit test. These added definitions are needed to add clarity to the proposed regulations at §§ 20.1701 through §§ 20.1705.

4

In § 20.1701, Use of process or other engineering controls , the word "decontamination" would be added to the list of examples of process or engineering controls that should be considered for controlling the concentration of radioactive material in air. The intent is to encourage licensees to consider decontamination, consistent with maintaining total effective dose equivalent (TEDE) ALARA, to reduce resuspension of radioactive material in the work place as a means of controlling internal exposure instead of using respirators.

Section 20.1702 would be revised by adding a footnote (2) to§ 20.1702(c) to clarify that if a licensee performs an ALARA analysis to determine whether or not respirators should be used, s2fety factors other than radiological may be taken into account. A reduction in the TEDE for a worker is not reasonably achievable if an attendant increase in the workers' industrial health and safety risk would exceed the benefit obtained by the reduction in the radiation risk. Regulatory Guide 8.15 (DG-8022) and NUREG-0041 will address in more detail how factors such as heat, discomfort, reduced vision , etc., associated with respirator use, might reduce efficiency or increase stress thereby increasing external dose or health risk. Considerable licensee judgment is necessary in determining an appropriate level of respiratory protection in many cases.

Section 20.1703 states the requirements for licensees who use respiratory protection equipment to limit intake of radioactive material. The use of a respirator is by definition intended to limit intakes of airborne radioactive materials, unless the device is clearly and exclusively used for protection against non-radiological airborne hazards. Whether or not credit is taken for the device in estimating doses, it is the use of the respiratory protection device to limit intake of radioactive material and associated physiological stresses that would activate the requirements of§ 20.1703. Thus § 20.1703 can be viewed as defining the minimum respiratory protection program expected of any licensee who assigns or permits the use of respirators .

5

• I In § 20.1703(a), the phrase "pursuant to § 20.1702" would be deleted. This language has been misinterpreted to mean that an approved respiratory protection program is not needed if respirators are used when concentrations of radioactive material in air are already below values that define an airborne radioactivity area. This is not the case and the proposed § 20.1703 should make it clear that, if a licensee uses respiratory protection equipment "to limit intakes,"

the provisions of § 20.1703 apply as a minimum.

In§ 20.1703(a)(1), (proposed§ 20.1703(a)), licensees are permitted to use only respirators that have been tested and certified "or had certification extended" by NIOSH. The words "or had certification extended" would be deleted because all these extensions have expired and no new extensions will be granted.

In § 20.1703(a)(2), (proposed§ 20.1703(b)), licensees are permitted to apply for authorization to use equipment that has not been tested or certified by NIOSH and "has not had certification extended by NIOSH/MSHA." The words "has not had certification extended by NIOSH/MSHA" would be deleted because all these extensions have expired and no new extensions will be granted. The words "to the NRC" are added to make it clear that applications for authorized use of respiratory equipment are to be submitted to the Commission.

In § 20.1703(a)(3), (proposed§ 20.1703(c)), paragraphs (c)(1) through (5) are retained as presently codified with the exception of some minor editing and that paragraph (c)(*~~ would be reworded to improve clarity, reorder priorities, and bring together in one paragraph all of the elements of the required written procedures. Paragraph (c)(5) would be revised to clarify that the worker's medical evaluation for using non-face sealing respirators occurs prior to first field use rather than prior to first fitting (as required for tight fitting respirators) because fit testing is not needed for these types.

6

A new§ 20.1703(c)(6) would be added to require fit testing prior to first field use of tight fitting, face sealing respirators and periodically thereafter. This proposed change would clarify when and how often fit testing is required. The licensee would specify a frequency of retest in the procedures, not to exceed 3 years . This differs from the ANSI recommendation of annual fit testing . The NRC believes that if a licensee is alert to physiological changes that might affect an individual's ability to wear a respirator safely, annual fit testing is an excessive burden. A requirement to wear properly fitted respirators is currently in the footnotes to Appendix A to

- Part 20 and would be moved to the body of the rule. Several general programmatic requiremer.ts currently found in footnotes to Appendix A to Part 20 would be moved to the text of the rule where they more appropriately belong and to ensure that they are not overlooked by licensees.

The new§ 20.1703(c)(6) would also codify existing NRC staff guidance and ANSI recommendations regarding the test "fit factors" that must be achieved in order to use the APFs and the frequency of fit testing . Specifically, fit testing with "fit factors" 2 10 times the APF would be required for negative pressure devices. A fit factor 2 100 would be required for all tight fitting face pieces used with positive pressure, continuous flow, and pressure-demand devices.

This provision is intended to maintain a sufficient margin of safety to accommodate the greater difficulty in maintaining a ::,ood "fit" under field and work conditions as compared to fit test environments.

The proposed § 20.1703(c)(6) would also require retesting at a frequency not to exceed 3 years. Guidance in the proposed revision of Regulatory Guide 8.15 (DG-8022) on the frequency of fit testing suggests a retest period not to exceed 3 years. Currently, most licensees perform annual fit testing. The proposed 3-year retesting does not agrE'e with the ANSI recommendation for annual retesting . The NRC believes that a 3-year interval between fit tests 7

is adequate to protect workers under normal circumstances, given adequate surveillance of workers for physiological changes . Regulatory Guide 8.15 discusses what constitutes an adequate surveillance program, including being alert to circumstances such as significant weight loss or gain, facial changes, etc., that would suggest more frequent fit testing . Transient workers might require more frequent retesting because continuous monitoring for physiological changes is impracticable.

The current§ 20.1703(a)(4), which lists requirements for licensees to issue a written policy statement, would be deleted because the NRC believes that this policy statement is not needed.

This change is proposed because all of the elements required to be in the policy statement are already found in Pa:t 20 and in the requirement for licensees to have and implement written procedures (see proposed § 20.1703(c)(4)).

Section 20.1703(a)(6) would become§ 20.1703(e) and would be clarified and expanded to emphasize the existing requirements that provisions be made for vision correction , adequate communications, and low-temperature work environ:11ents. In order to comply with these requirements, a licensee would need to take into account the effects of restricted vision and communication limitations as well as the effects of adverse environmental conditions on the equipment and the wearer. The NRC considers the inability of the respirator wearer to read postings, operate equipr,,ent and/or instrumentation, or properly identify hazards to be an unacceptable degradation of personnel safety.

A requirement for licensees to consider low-temperature work environments when selecting respiratory protection devices would be added to the proposed § 20.1703(e) . For example, the moisture from exhaled air when temperatures are below freezing could cause the exhalation valve on negative pressure respirators to freeze in t~e open position . The open valve would provide a pathway for unfiltered air into the respirator inlet covering without the user being aware 8

of the malfunction. Lens fogging that reduces vision in a full face piece respirator is another problem that can be caused by low temperature.

The reference to skin protection currently found in § 20.1703(a)(6) would be deleted in the proposed§ 20.1703(e). The NRC does not consider skin protection an appropriate reason for the use of respirators (with the exception of air supplied suits). Limitation of skin dose is currently dealt with elsewhere in the regulations for example in § 20.1201 (a)(2)(ii), skin dose limit. It may be inconsistent with ALARA to use tight fitting respirators solely to prevent facial contamination; other protective measures such as the use of facelets instead of respirators or decontamination shoulri be considered . Facial contamination may result in a less significant dose than that received as a result of respirator use or prior decontamination of the area.

A new § 20.1703(f) would be added to bring a requirement for standby rescue persons, currently found in a footnote in Appendix A to Part 20, into the rule. This new paragraph would retain a requirement for the presence of standby rescue persons whenever one-piece atmosphere-supplying suits, or any other combination of supplied air respirator device and protective equipment are used that are difficult for the wearer to take off unassisted. Standby rescue workers would also need to be in direct communication with such workers, be equipped with appropriate protective clothing and devices, and be immediately available to provide needed assistance in the event that the air supply fails. Without continuous air supply, unconsciousness can occur within seconds.

A new § 20.1703(9) would move a requirement from a footnote in Appendix A to Part 20, into the rule. This section would specify the minimum quality of supplied breatning air, as defined by the Compressed Gas Association (CGA) in their publication G-7.1, "Commodity Specification for Air," 1989 (ANSI-CGA G-7 .1, 1989), that must be provided whenever atmosphere-supplying respirators are used. This change to recognizing the CGA recommendations for air quality was 9

initiated by NIOSH and endorsed by ANSI. The quantity of air supplied , as a function of air pressure or flow rate, would be specified in the NIOSH approval certificate for each particular device and is not addressed in the proposed rule.

A new § 20.1703(h) is added to clarify and move a requirement from the footnotes of Appendix A to Part 20, into the rule. This section prohibits the use of respirators whenever any material or substance might interfere with the seal of the respirator. The intent of this provision is to prevent the presence of facial hair, cosmetics, spectacle earpieces, surgeons caps, and other things from interfering with the respirator seal and/or proper operation of the respirator.

Currently, § 20.1703(b )( 1) discusses selection of respiratory protection equipment so that protection factors are adequate to reduce intake. This paragraph permits selection of fess protective devices if that would result in optimizing TEDE. The NRC believes that this requirement is redundant with the requirement to be ALARA. These recommendations are being removed and will be discussed in the revised Regulatory Guide 8.15.

The remainder of§ 20.1703(b)(1) would become§ 20.1703(i) and be revised to incorporate the new ANSI terminology for "assigned protection factor" and to retain the provision for changing intake estimates if later, more accurate bioassay measurements show that exposure was greater or less than initially estimated.

Current§ 20.1703(b)(2), specifying procedures for applying to the NRC to use higher APFs, is renumbered as § 20.1705.

Current§ 20.1703(c) would be removed because it requires licensees to use as emergency devices only respiratory protection equipment that has been specifically certified or had certification extended for emergency use by NIOSH. This approval category no longer exists.

Acceptable types of emergency and escape equipment will be discussed in the revisions of Regulatory Guide 8.15 and NUREG-0041. Because only equipment approved by NIOSH or 10

NRC can be used in the respiratory protection program pursuant to§ 20.1703(a) and (b) , this provision is considered redundant.

Current§ 20.1703(d) would be deleted. This section currently requires a licensee to notify in writing the director of the appropriate NRC Regional Office at least 30 days before the date that respiratory protection equipment is first used under the provisions of either current § 20.1703(a) or (b). All licensees who possess radioactive material in a form that requires a respiratory protection program are identified during the license application, amendment, or renewal processes. Their programs would be reviewed during this process. A 30-day notification requirement imposes a needless administrative burden on licer.:~es with no increase in worker health and safety. This proposed change is considered to be a burden reduction.

Section 20.1704(a) would be revised to clarify that ALARA considerations are included in any restrictions imposed by the Commission in addition to those found in §§ 20.1702, 20.1703, and Appendix A to Part 20 on the use of respiratory protection equipment for the purpose of limiting exposures of individuals to airborne radioactive materials.

Appendix A to Part 20 - "Protection Factors (PF) for Respirators ," would be modified extensively. In general, new devices are recognized, APFs are revised to be consistent with current ANSI guidance and technical knowledge, and the footnotes to Appendix A are moved, deleted, revised, or adjusted so that only those necessary to explain the table remain.

Footnotes that are instructive or that facilitate implementation of the rule would be moved to Regulatory Guide 8.15. Several footnotes are considered to be redundant in that they reiterate NIOSH certification criteria to be discussed in NUREG-0041 and would be removed. Generic regulatory requirements, previously contained in footnotes in Appendix A to Part 20 would be moved to the codified text of Part 20.

11

The column headed "Tested and Certified Equipment," would be deleted. The references to Titles 30 and 42 of the CFR currently found in this column apply primarily to respirator manufacturers and are not very useful to NRC licensees. Instruction on how to determine if a respirator is NIOSH approved will be provided in the revision to NUREG-0041.

Current footnote a to Appendix A to Part 20 would be deleted because it is considered to be redundant with air sampling requirements and requirements for estimating possible airborne concentration addressed in the proposed rule at§ 20.1703(c)(1) and § 20.1703(i).

Current footnote b, which permits the use of devices only when nothing interferes with the seal ~fa face piece, would be mover-1 +o the codified text at § 20.1703(h).

Current footnote c, which defines the symbols for modes of operation would be revised to fit the new list of respiratory devices in Appendix A to Part 20 consistent with ANSI 288.2-1992 and become footnote b.

Current footnote d.1 would be removed because the essential information regarding the meaning and use of APF is found in the proposed rule at § 20.1703(i). Further guidance regarding the application and limitation of APFs would be provided in the revisions of Regulatory Guide 8.15 and NUREG-0041.

Current footnote d.2(a) states that APFs are only applicable for trained individuals who are properly fitted and for properly maintained respirators. This footnote is redundant with the current and proposed § 20.1703 and would be removed. Adequate provisions for training, fit-testing, and equipment maintenance are found in the proposed rule at§ 20.1703(c)(4).

Current footnote d.2(b) states that APFs are applicable for air-purifying respirators only when high-efficiency particulate filters are used in atmospheres not deficient in oxygen and not containing radioactive gas or vapor respiratory hazards. This statement would be revised in proposed footnote c to say that if using a respirator with an APF greater than 100, a filter with a 12

minimum efficiency of 99.97 percent must be used . Further guidance will be provided in Regulatory Guide 8.15 and NUREG-0041. The definitions of filter types and efficiencies will be discussed in the revisions of Regulatory Guide 8.15 and NUREG-0041.

Current footnote d.2(c) states that APFs cannot be used for sorbents against radioactive gases and/or vapors (e.g., radioiodine). This is no longer an absolute prohibition. A provision would be made in the new proposed footnote d for licensees to apply to the Commission for the use of an APF greater than 1 for sorbent cartridges.

Current footnote d.2(d) restates part of the NIOSH approval criteria for air quality for supplied c:;:- respirators and self-contained breathing apparatus. This requirer.,ent would be changed to reflect the fact that air quality standards derive from ANSI's recognition of the Compressed Gas Association guidance, and moved to the rule at § 20.1703(9). Air quality is discussed further in Regulatory Guide 8.15 and NUREG-0041.

The current footnote e makes it clear that the APFs for atmosphere-supplying respirators and self-contained breathing apparatus are not applicable in the case of contaminants that present a skin absorption or submersion hazard . This statement would be retained in footnoted in the proposed Appendix A to Part 20. However, the current exception provided for tritium oxide requires correction in that the effective protection factor cannot exceed 3, rather than 2 as stated . This correction would be made in footnoted of the proposed Appendix A to Part 20. A discussion of the basis for this change will be found in revised NUREG-0041.

Current footnote f observes that canisters and cartridges for air purifying respirators will not be used beyond service-life limitations. This observation restates a NIOSH approval criterion and is more appropriate to guidance than to the regulations. This footnote would be deleted.

Service life limitations are addressed in Regulatory Guide 8.15 and NUREG-0041 .

13

The current footnote g addresses four issues. The first limits the use of half-mask face piece air purifying respirators to "under-chin" types only. This limitation would be retained as footnote (f) to the proposed new Appendix A to Part 20. The only type of face piece eliminated by this requirement is the so-called "quarter-mask" which seals over the bridge of the nose, around the cheeks and between the point of the chin and the lower lip. These devices exhibit erratic face-sealing characteristics, especially when the wearer talks or moves his/her mouth.

The second issue precludes this type of respirator if ambient airborne concentrations can reach instantaneous values greater than 10 times the pertinent values in Table 1, Column 1 of Appendix B to Part 20. Because respirator assignment is now based on TEDE, ALARA, and other consideration, this part of current footnote g would be deleted from the proposed footnote f.

The third issue precludes the use of this type of respirator for protection against plutonium or other high-toxicity materials. Half-mask respirators, if properly fitted, maintained and worn, provide adequate protection if used within the limitations stated in the NIOSH approval and in the rule. The NRC finds no technical or scientific basis for continuing this prohibition in view of current knowledge and proposes to remove it.

Finally this footnote requires that this type mask be tested for fit (user seal check) before each use. This provision would be removed because the proposed§ 20.1703(c)(31.vould require a user to perform a fit check (e.g., negative pressure check, positive pressure check, irritant smoke check) each time a respirator is used .

Current footnote h provides several conditions on air-flow rates necessary to operate supplied air hoods effectively. Because all of these requirements are elements of the NIOSH approval criteria, they are redundant and would be removed. However, these NIOSH requirements will be discussed in the revision to NUREG-0041.

14

Current footnote I specifies that appropriate protection factors be determined for atmosphere-supplying suits based on design and permeability to the contaminant under conditions of use. Conditions for the use of these devices are retained in footnote g to the proposed revision of Appendix A to Part 20. Guidance on the use of these devices would be included in the revision to Regulatory Guide 8.15. Current footnote I also requires that a standby rescue person equipped with a respirator or other apparatus appropriate for the potential hazards, and communications equipment be present whenever supplied-air suits are used. This requirement would be deleted from the footnotes to Appendix A to Part 20 and moved to the body of the rule at § 20.1703(f).

Current footnote j states that NIOSH approval schedules are not available for atmosphere-supplying suits. This information and criteria for use of atmosphere supplying suits would be addressed in footnote g to the proposed Appendix A to Part 20. Note that an APF is not listed for these devices. Licensees would be permitted to apply to the Commission for the use of higher APFs in accordance with§ 20.1703(b).

Current footnote k permits the full face piece self-contained breathing apparatus (SCBA),

when operating in the pressure-demand mode, to be used as an emergency device in unknown concentrations. This provision would be retained in footnote I to the proposed Appendix A to Part 20 and full face piect:: SCBA operating in positive pressure, recirculating mode is added.

Current footnote I requires quantitative fit testing with a leakage less than 0.02 percent for the use of full face piece, positive pressure, recirculating mode SCBA. This requirement would be removed from the rule to be consistent with ANSI guidance and addressed in the revision to Regulatory Guide 8.15.

Current footnote I also states that perceptible outward leakage of breathing gas from this or any positive pressure SCBA whether open circuit or closed circuit is unacceptable, because 15

service life will be reduced substantially. This provision would be retained in footnote I to the proposed Appendix A to Part 20.

Current footnote I also requires that special training in the use of this type of apparatus be provided to the user. The NRC believes that the training requirement that would be retained at

§ 20.1703(c)(4) is adequate to assure the training necessary for the use of SCBA devices. This element of footnote I would be removed.

Note 1 to the current Appendix A to Part 20 discusses conditions under which the protection factors in the appendix may be used, warns against assuming that listed devices are effective against chemical or respiratory hazards other than radiological hazards, and sta+-3s the need to take into account applicable approvals of the U.S. Bureau of Mines/NIOSH when selecting respirators for nonradiological hazards. Note 1 would be retained as foot:iote (a) to the proposed Appendix A to Part 20 and would be revised to reference Department of Labor (DOL) regulations at 29 CFR 1910. The NRC believes that these conditions are essential to the safe use of APFs and that the DOL regulations are also c:.pplicable whenever other than radiological respiratory hazards are present.

Note 2 to the current Appendix A to Part 20 warns that external dose from submersion in high concentrations of radioactive material may result in limitations on occupancy being governed by external de,..,e limits. This note would be retained as the second paragraph of footnote a to the proposed Appendix A to Part 20.

In the title of Appendix A to Part 20, and throughout the proposed rule, the term "assigned protection factor" (APF) is used to be consistent with the new ANSI ZSS.2-1992 terminology.

Although ANSI suggested an APF = 10 for all half-mask face piece disposable respirators, disposables that do not have seal enhancing elasto:neric components and are not equipped with two or more adjustable suspension straps would be permitted for use but would not have an 16

APF assigned (i.e., no credit may be taken for their use). The NRG believes that without these components it is difficult to maintain a seal in the workplace. These devices have little physiological impact on the wearer, may be useful in certain situations, and they may accommodate workers who request respiratory protection devices as required by OSHA.

Medical screening is not required for each individua.1 prior to use because the devices impose very little physiological stress. In addition, fit testing is not required because an APF is not specified (i.e., no credit may be taken for their use). However, all other aspects of an acceptable program specified in § 20.1703 are required including training of users in the use and limitations of the revice. The NRG believes that this provision allows the flexible and effective use of these devices without imposing conditions that are impracticable. However, for those licensees who would like to use the ANSI recommended APF of 10, proposed footnote e to Appendix A to. Part 20 would permit an APF of 10 to be used if the licensee can demonstrate a fit factor of at least 100 using a validated or evaluated quantitative or qualitative fit test. This requirement is appropriate because fit testing is an implicit component of the ANSI approval process.

The half-mask face piece respirator would continue to be approved, but relatively new variations are referred to in the industry as "reusable," "reusable-disposable," "face-piece-filtering" or "maintenance-free" devices. In these devices, including those considered to be disposables, the filter medium may be an integral part of the face piece, is at least 99 percent efficient, and may not be replaceable. Also, the seal area is enhanced by the application of plastic or rubber to the face-to-face piece seal area and the 2 or more suspension straps are adjustable. These devices are acceptable to the NRG, are considered half masks, may be disposable, and would be given an APF = 10, consistent with ANSI recommendations.

17

The assigned protection factor for full face piece air purifying respirators operating in the negative pressure mode would be increased from 50 to 100. This change is consistent with ANSI recommendations and industry test results. The current Appendix A to Part 20 lists a protection factor of 50 because one design that was tested at Los Alamos in 1975 did not meet the PF 100 criterion. This device is no longer available.

A fit factor of 10 times the APF for negative-pressure air-purifying respirators, which must be obtained as a result of required fit testing under§ 20.1703(c)(6), is recommended by ANSI and w_ould be required under the proposed rule; that is, a person would have to achieve a minimum of 1,000 on a fit test in order to use an APF of 100 in the field. Use of a fit factor of 10 times the APF effectively limits internal dose and accounts for any respirator leakage that might occur during workplace activities. Fit factors of 10 times the APF were previously not required for such devices.

A new category of respirator, the loose-fitting face piece, positive pressure (powered) air purifying type, would be included in the proposed Appendix A to Part 20. An APF of 25 would

• be assigned to this new device in accordance with ANSI 288.2-1992.

The half-mask and the full face piece air-line respirators operating in demand mode would be listed with APF unchanged at 5. The NRC believes that supplied-air respirators operating in the demand mode should be used with great care in nuclear applications. Because they are very similar in appearance to more highly effective devices (continuous flow and pressure-demand supplied air respirators), they might mistakenly be used instead of the more protective devices.

The APFs for half-and full-face piece air-line respirators operating on continuous flow would be reduced from 1,000 to 50 and from 2,000 to 1,000 respectively. The APF for a full face piece air-line respirator operating in pressure-demand mode would be reduced from 2,000 to 1,000.

18-

These changes are based on ANSI recommendations and the results of field measurements indicating that these devices are not as effective as originally thought. This change would have little impact on licensees because typical workplace concentrations encountered are far less than 1000 times the derived air concentrations (DACs). However, licensees may apply for higher APFs if needed and justified. A half-mask air-line respirator operating in pressure-demand mode would be added to Appendix A with an APF of 50 based on ANSI recommendations. The helmet/hood air-line respirator operating under continuous flow would be retained with the APF listed as 1,000. Current footnote h which specifies NIOSH certification criteria for flow rates would be removed. The criteria for air flov.- ,ates are part of the NIOSH approval and would be addressed in the revision to NUREG-0041.

The new loose fitting face piece design is also included as an air-line respirator operating under continuous flow. This device would be assigned an APF of 25 in the proposed Appendix A to Part 20 consistent with ANSI recommendations.

The air-line atmosphere-supplied suit would not be assigned an APF. These devices have been used for many years in radiological environments such as control rod drive removal at boiling water reactors with no APF. These devices are primarily used as contamination control devices, but they are supplied with air that the wearer breathes. No problems are known to have occurred at nuclear power plants or other NRC licensees that would disallow use of these devices. The NRC is allowing the use of non-NIOSH-approved suits but wearers are required to meet all other respirator program requirements in § 20.1703 except the need for a fit test.

Licensees would still have an option to apply to the Commission for higher APFs in accordance with proposed § 20.1703.(b). Requirements for standby rescue persons apply to these devices

(§ 20.1703(f)).

19

In the proposed Appendix A to Part 20, APFs for SCBA devices would remain unchanged.

Use of SCBA in demand open circuit and demand recirculating mode requires considerable caution. In the NRC's view, the performance level and reliability of these devices is questionable. The chance of face piece leakage when operating in the negative pressure mode is considerably higher than when operating in a positive pressure mode. This is especially critical for devices that could be mistakenly used in emergency situations. Although ANSI lists high APFs for these devices, they are not recommended by the NRC for use and acceptable alternative devices are readily available. Footnote h requires that controls be implemented to assL!:-.: that these devices are not u::::l in immediately dangerous to life and health (IDLH) areas.

In proposed footnoted, a specific statement would be added to exclude radio8ctive noble gases from consideration as an airborne hazard and advising that external (submersion) dose considerations should be the basis for protective actions. In the current rule, DAC values are listed for each noble gas isotope. This has led some licensees to inappropriately base respirator assignments in whole or in part on the presence of these gases. The requirement for monitoring external dose can be found in 10 CFR 20.1502.

The complete proposed changes to Part 20, Subpart H and Appendix A to Part 20 are presented in the codified text section of this document.

Ill. Issue of Compatibility for Agreement States In accordance with the new adequacy and compatibility policy and implementing procedures approved by the Commission on June 30, 1997, the proposed modifications to§§ 20.1701 through 20.1703, and § 20.1705 have health and safety significance and Agreement States 20

should adopt the essential objectives of these rule modifications in order to maintain an adequate program. Therefore, these provisions are assigned to the "Health and Safety (H&S)"

category. The proposed definition of Assigned Protection Factor (APF) because of its precise operational meaning, is designated as compatibility category C to help insure effective communication. Therefore, Agreement States should adopt the essential objectives of this provision to avoid conflicts, duplication or gaps. The proposed definitions of Disposable respirator, Fit check, Fit factor and Fit test, are stated in general terms and are therefore designated as compatibility category D, not required for purposes of compatibility. Flexibility is als'.) provided to States regarding § 20.1704 in how they handle imposition of additional restrictions on the use of respiratory protection. Therefore, this provision is designated as compatability category D. Comments are specifically requested on whether assigning different compatibility categories to the proposed new definitions creates any implementation problems or inconsistencies.

Appendix A to 10 CFR Part 20 is designated as compatibility category B because assigned protection factors (APFs) provide acceptable levels of protection to be afforded by respirators.

Additionally, although § 20.1705 permits applying for the use of higher APFs on a case by case basis, consistency is required in APFs that are established as acceptable in NRC and Agreement State regulations to reduce impacts on licensees who may operate in multiple jurisdictions.

These proposed amendments were provided to the Agreement States during the NRC staff review process via the use of the NRC rulemaking bulletin board and notification to the States of its availability. Two comments were received. One suggested assigning compatibility categories to the five new definitions, which has been done in this proposed rule. A second 21

noted that removal of generic requirements from the footnotes to Appendix A greatly improved the rule.

IV. Finding of No Significant Environmental Impact: Availability The NRC has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in ~ubpart A of 10 CFR Part 51, that the proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and therefore, an environmental impact statement is not required.

The proposed amendment addresses technical and procedural improvements in the use of respiratory protection devices to maintain total occupational dose as low as is reasonably achievable. None of the impacts associated with this rulemaking have any effect on any places or entities outside of a licensed site. An effect of this proposed rulemaking is expected to be a decrease in the use of respiratory devices and an increase in engineering and other controls to reduce airborne contaminants. It is expected that there would be no change in radiation dose to any member of the public as a result of the revised regulation.

The determination of this environmental assessment is that there will be no sign;7:cant offsite impact to the public from this action. Therefore,. in accord with its commitment to complying with Executive Order 12898 - Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, dated February 11, 1994, in all its actions, the NRC has also determined that there are no disproportionate, high, and adverse impacts on minority and low-income populations. The NRC uses the following working definition of "environmental justice": the fair treatment and meaningful involvement of all people,. regardless of race, 22

ethnicity, culture, income, or educational level with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. Comments on any aspect of the environmental assessment may be submitted to the NRG as indicated under the ADDRESSES heading.

The NRG has sent a copy of the environmental assessment and this proposed rule to every State Liaison Officer and requested their comments on the environmental assessment.

The draft environmental assessment is available for inspection at the NRG Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. Single copies of this document are available as indicated in the ADDRESSES heading.

V. Paperwork Reduction Act Statement This proposed rule contains amendments to reduce the infor_mation collection requirements contained in 10 CFR Part 20 that are considered to be insignificant, (250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br /> annually) when compared with the overall requirements of the CFR Part (210, 205 hours0.00237 days <br />0.0569 hours <br />3.38955e-4 weeks <br />7.80025e-5 months <br /> annually). NRG does not consider this reduction in the burden to be significant enough to trigger the requirements of the Paperwork Reduction Act of 1995 (44. U.S.C. 3501 et seq.). Existing requirements were approved by the Office of :v1anagement and Budget, approval number 3150-0014.

23

Public Protection Notification If an information collection does not display a currently valid 0MB control n.umber, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

VI. Regulatory Analysis The NRC has prepared a regulatory analysis for the proposed amendment. T!ie analysis examines the benefits and impacts considered by the NRC. The regulatory analysis is available for inspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level),

Washington, DC. Single copies are available as indicated under the ADDRESSES heading.

VII. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the NRC certifies that, if adopted, this proposed rule would not have a significant economic impact on a substantial number of small entities. The anticipated impact of the proposed changes would not be significant because the revised regulation basically represents a continuation of current practice.

The benefit of the proposed rule is that it would provide relief from certain reporting and recordkeeping requirements, incorporate several ANSI recommendations for improved programmatic procedures, and permit the use of new, effective respiratory devices, thus increasing licensee flexibility.

24

~

The NRC is seeking public comment on the initial regulatory flexibility certification. The NRC is seeking comment particularly from small entities as defined under the NRC's size standards 10 CFR 2.810, as to how the proposed regulations would affect them and how the regulations may be implemented or otherwise modified to impose less stringent requirements on small entities while still adequately protecting the public health and safety. Any small entity subject to this regulation who determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should offer comments that specifically discuss the following items:

• (a) The licensee's size and how the proposed regulation would result in a significant economic burden or wrether the resources necessary to implement this amendment could be more effectively used in other ways to optimize public health and safety, as compared to the economic burden on a larger licensee; (b) How the proposed regulation could be modified to take into account the licensees' differing needs or capabilities; (c) The benefits that would accrue, or the detriments that would be avoided, if the proposed regulation were modified as suggested by the licensee; (d) How the proposed regulation, as modified, could more closely equalize the impact of NRC regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any individual or group; and (e) How the proposed regulation, as modified, would still adequately protect the public health and safety.

The comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. ATTN: Rulemakings and Adjudications Staff.

Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4: 15 pm Federal workdays.

25

VIII. Backfit Analysis Although the NRG staff has concluded that some of the changes being proposed constitute a reduction in burden, the implementation of these and other changes will require revisions to licensee procedures constituting a potential backfit under 10 CFR 50.109(a)(1 ). Under

§ 50.109(a)(2), a backfit analysis is required unless the proposed rule meets one of the exceptions listed in § 50.109(a)(4). This proposed rule meets the exception at§ 50.109(a)(4)(iii) in that it is redefining the level of adequate protection as regards the use of respirators for radiological protection.

Section II, Summary of the Proposed Changes, summarizes the proposed changes to Subpart H of 10 CFR Part 20. The reasons for making these changes are also provided. Many of the proposed changes are considered by the NRG to constitute a redefinition of adequate level of protection in that they reflect new consensus technical guidance published by the American National Standards Institute (ANSI) on respiratory protection developed since 10 CFR Part 20, Subpart H was published. The changes include recognizing new respirator designs and types that were not available 20 years ago, changing the assigned protection factors (APFs) based on new data, deleting certain reporting requirements which are considered no longer needed for oversight of a mature industry, and numerous procedural improvements that have been developed and proven by respiratory practitioners.

In conclusion, the Commission believes that the proposed changes constitute a burden reduction with the exception of the need to revise procedures to implement the requirements.

The proposed changes also clearly redefine the level of adequate protection required for workers who use respiratory protection and are, therefore, the type of change for which a backfit analysis is not required under§ 50.109(a)(4)(iii).

26

List of Subjects in 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recording requirements, Special nuclear material, Source material, Waste treatment and disposal.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C.

553, the NRG is proposing to adopt the following amendments tc ~ 0 CFR Part 20.

PART 20- STANDARDS FOR PROTECTION AGAINST RADIATION

1. The authority citation for Part 20 continues to read as follows:

AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936,937,948,953,955, as amended (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.5841, 5842, 5846).

2. Section 20.1003 is amended by adding the definitions Assigned protection factor (APF), Disposable respirator, Fit check, Fit factor, and Fit test to read as follows:

§ 20.1003 Definitions.

Assigned protection factor (APF) means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to 27

properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

Disposable respirator means a respirator for which maintenance is not intended and that is designed to be discarded after excessive resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

Fit check (user seal check) means a performance check conducted by a respirator wearer to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate.

Fit factor means a quantitative measure of the fit of a particular respirator to a particular individual.

Fit test means a test, quantitative or qualitative, to evaluate the fit of a respirator on an individual and to determine a fit factor.

3. Section 20.1701 is revised to read as follows:

§ 20.1701 Use of process or other engineering controls.

The licensee shall use, to the extent practicable, process or other engineering controls (e.g.,

containment, decontamination, or ventilation) to control the concentration of radioactive material in air.

28

4. In § 20.1702, paragraph (c) is revised to add the following footnote:

§ 20.1702 Use of other controls.

(c) Use of respiratory protection equipment2 ; or 2

If the licensee performs an ALARA analysis to determine whether or not respirators should be used, safety factors other than radiological may be taken into consideration and the impact of the use of respirators on workers industrial health and safety risk should be considered .

• 5. Section 20.1703 is revised to read as follows:

§ 20.1703 Use of individual respiratory protection equipment.

.If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material, (a) The licensee shall use, only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) ..

(b) If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the NRC for authorized use of this equipment except as provided in this part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information.

(c) The licensee shall implement and maintain a respiratory protection program that includes:

29

(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures; (2) Surveys and bioassays, as necessary, to evaluate actual intakes; (3) Testing of respirators with APFs for operability (fit check for face sealing devices and functional check for others) immediately prior to each use; (4) Written procedures regarding monitoring, including air sampling and bioassays; training of respirator users; fit testing; respirator selection; breathing air quality; inventory and control; storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment; recordkeeping; and limitations on periods of respirator use and relief from respirator use; (5) Determination by a physician before the initial fitting of face sealing_ respirators, before the first field use of non-face sealing respirators, and either every 12 months thereafter, or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment; (6) Fit testing, with fit factor :.:: 10 times the APF for negative pressure devices, and a fit factor :.:: 100 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed 3 years. .

(d) The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

(e) The licensee shall use equipment, within limitations for type and mode of use and shall make provision for vision correction, adequate communication, low temperature work 30

environments, and the concurrent use of other safety or radiological protection equipment in such a way as not to interfere with the proper operation of the respirator.

(f) Standby rescue persons are required whenever one-piece atmosphere-supplying suits,

• or any combination of supplied air respiratory protection device and personnel protective equipment are used, from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons, shall observe or otherwise be in direct communication with the workers and must be immediately available to assist ther,; in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be available to effectively assist all users of this type of equipment.

(g) Whenever atmosphere-supplying respirators are used, they must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association and endorsed by ANSI, in publication G-7.1, "Commodity Specification for Air," 1989, (ANSI-CGA G-7.1, 1989).*

(h) No material or substance, the presence or absence of which is under the control of the respirator wearer, may be present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator ;c:1cepiece.

(i) In estimating the exposure of individuals to airborne radioactive materials, the

.concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the exposure is later found to be greater than estimated, the corrected value must be used. If the exposure is later found to be less t'.lan estimated, the corrected value may be used.

31

6. Section 20.1704 is revised to read as follows:

§ 20.1704 Further restrictions on the use of respiratory protection equipment.

The Commission may impose restrictions in addition to those in§§ 20.1702, 20.1703, and Appendix A to Part 20 in order to:

(a) .Ensure that the respiratory protection program of the licensee is adequate to limit exposures of individuals to' airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and (b) Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

7. Section 20.1705 is added to read as follows:

§ 20.1705 Application for use of higher assigned protection factors.

The licensee shall obtain authorization from the Commission before using assigned protection factors in excess of those specified in Appendix A to Part 20. The Commission may authorize a licensee to use higher assigned protection factors on receipt of an application that -

(a) Describes the situation for which a need exists for higher protection factors; and (b) Demonstrates that the respiratory protection equipment provides these higher protection factors under the propos"'d conditions of use.

8. Appendix A to Part 20 is revised to read as follows:

APPENDIX A TO PART 20 ASSIGNED PROTECTION FACTORS FOR RESPIRATORSa Assigned Protection Factors Description Modesb I Particulate* I Gases and vaporsd 32

I. AIR PURIFYING RESPIRATORS Single-use disposable* NP (e)

Facepiece, half mask' NP 10 Facepiece, full NP 100 Facepiece, half mask pp 50 Facepiece, full pp 1000 HelmeUhood pp 1000 Facepiece, loose-fitting pp 25 II. ATMOSPHERE SUPPLYING RESPIRATORS

1. Air-line respirator Facepiece, half mask D 5 5 Facepiece, half mask CF 50 50 Facepiece, half mask PD 50 50 Facepiece, full D 5 5 Facepiece, full CF 1000 1,000 Facepiece, full PD 1000 1,000 HelmeUhood CF 1000 1,000 Facepiece, loose-fitting CF 25 25 Suit CF (g) (g)

2. Self-contained t.,aathing Apparatus (SCBA)

Facepiece, full D 50h 50h Facepiece, full PD 10,000; 10,000; Facepiece, full RD 5Qh 50h Facepiece, full RP 10,000; 10,0QQi Ill. COMBINATION RESPIRATORS Any combination of air-purifying and atmosphere-supply respirators Assigned protection factor for type and mode of operation as listed above

a. These assigned protection factors apply only in a respiratory protection program that meets the requirements of this Part. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances must also comply with Department of Labor regulations contained in 29 CFR 1910.

Radioactive contaminants for which the concentration values in Table 1, Column 3 of Appendix B to Part 20 are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits.

33

b. The mode symbols are defined as follows:

NP = negative pressure (air-purifying respirator)

PP = positive pressure (air-purifying respirator)

CF= continuous flow (supplied-air respirator)

D = demand (supplied-air respirator)

PD= pressure-demand (open circuit, supplied-air respirator)

RD= demand, recirculating (closed circuit SCBA)

RP= positive pressure, recirculating (closed circuit SCBA).

c. Air purifying respirators with APF :5: 100 must be equipped with particulate filters that are at least 99 percent efficient. Air purifying respirators with APF > 100 must be equipped with particulate filters that are at least 99.97 percent efficient.

d. Excluding radioactive contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of 3 is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external (submersion) dose considerations. The licensee may apply to the Commission for the use of an APF greater than 1 for sorbent cartridges as protection against airborne radioactive gasses and vapors (e.g., radioiodine).

e. Licensees may permit individuals to use this type of respirator who have not been medically screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized _that it is difficult to perform an effective positive or negative pressure pre-use fit check on tt,is type of device. All other respiratory protection program requirements listed in § 20.1703 apply. An assigned protection factor has not been assigned for these devices. However, an APF equal to 10 may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test.

f. Under-chin type only. No distinction is made in this Appendix between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece (e.g., disposable or reusable disposable). Hoth types are acceptable*

so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least 99 percent efficient and all other requirements of this part are met.

34

g. No NIOSH approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met [i.e.,

§ 20.1703].

h. The licensee should implement institutional controls to assure that these devices are not used in areas immediately dangerous to life and health (IDLH).

i. This type of respirator may be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure such as skin absorption shall be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device.

• Dated at Rockville, Maryland this i1 tiday of_µ: -1998.

For the Nuclear Regulatory Commission.

/

John C. Hoyle, Secretary of the Commission.

35

September 30, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ADM,DAS

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULEMAKING - RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURE Attached for docketing is a comment letter related to the subject proposed rulemaking.

This comment was received via e-mail on September 30, 1998. The submitter's name is Ashok K. Dhar, Mallinckrodt, Inc. Please send a copy of the docketed comment to Alan Roeckein (mail stop O11-F-1) for his records.

Attachment:

As stated cc w/o attachment:

A. Roecklein

September 30, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ADM,DAS

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULEMAKING- RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURE Attached for docketing is a comment letter related to the subject proposed rulemaking.

This comment was received via .e-mail on September 30, 1998. The submitter's name is Michael J. Benjamin, 403 West Main Street, Williston, SC 29853. Please send a copy of the docketed comment to Alan Roeckein (mail stop O11-F-1) for his records.

Attachment:

As stated cc w/o attachment:

A. Roecklein

September 29, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ADM.DAS ~Cl-~

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE- RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES Attached for docketing is a comment letter related to the subject proposed rulemaking.

This comment was received via the rulemaking website on September 28, 1998. The submitter's name is Daniel J. Strom, Risk Analysis & Health Protection, K3-56, PNNL, PO Box

• 999, Richland, WA 99352-0999. Please send a copy of the docketed comment to Alan Roecklein (mail stop O11-F-1) for his records.

Attachment:

As stated cc w/o attachment:

A. Roecklein

From: "Kim, Jessica Y" <Jessica.Kim@pseg.com>

To: "'Adria Byrdsong"' <ATB1@nrc.gov>

Date: Thu, Sep 14, 2000 9:16 AM

Subject:

RE: Public Comments Ms. Byrdsong:

Thank you for your kind reply. I would appreciate it if you could send me the index of comments. My fax number is 973-645-1103. Please address the fax to my attention.

Thank you, Jessica Kim PSE&G Law Department - Law Clerk 80 Park Plaza Newark, NJ 07102 tel. 970-430-6190 email: jessica.kim@pseg.com

---

Original Message-----

From: Adria Byrdsong [1]

Sent: Tuesday, September 12, 200_0 10:03 AM To: jessica.kim@pseg.com

Subject:

Public Comments Ms. Kim-Carol Gallagher forwarded your E-mail message to me regarding public comments on the Final Respirator Standard. To obtain copies of the comments on the proposed rule, please contact our Public Document Room at 202-634-3273 and provide them with the Federal Register citation 63 FR 38511 (July 17, 1998) and the name of the proposed rule, "Respiratory Protection and Controls to Restrict Internal Exposures." If you would like an index of comments, please provide me with your fax no. If you need any additional information, please let me know.

Adria Byrdsong Office of the Secretary U.S. Nuclear Regulatory Commission Mail Stop O-16C1 Washington, DC 20555-0001

Page 1 From: "Kim, Jessica Y" <Jessica.Kim@pseg.com>

To: "'cag@nrc.gov"' <cag@nrc.gov>

Date: Thu, Sep 7, 2000 12:09 PM

Subject:

Public Comments Ms. Gallagher, My name is Jessica Kim. I am a law clerk at PSE&G of New Jersey, and I would appreciate it if you can answer a quick research question.

Does the NRC keep a record of the public comments that were filed - either in a paper form or through the Rule Forum -after the comment period expires?

More specifically, I'm trying to track down a few public position papers that were submitted in response to the NRC's comments on the Final Standard as published in the Federal Register 63 FR 38511 (July 17, 1998). The Final Respirator Standard has been adopted by OSHA effective Aprile 8, 1998.

Where, within NRC, would I find a record of a public comment that were filed during the comment period for the Final Respirator Standard?

I would greatly appreciate any help you might give.

Thank You, Jessica Kim.

PSE&G Law Department - Law Clerk 80 Park Plaza Newark, NJ 07102 tel. 970-430-6190 email: jessica.kim@pseg.com

From: Carol Gallagher To: Adria Byrdsong .

Date: Fri, Sep 8, 2000 11 :34 AM

Subject:

Fwd: Public Comments

Adria, Please see the attached message. It sounds to me like this individual is looking for something dealing with comments/papers dealing with the proposed rule on Respiratory Protection & Controls to Restrict Internal Exposure. It was published in July 1998 and is no longer on the Rulemaking website (because of its age). Since SECY has the official docket, could you possibly help her?

Thanks, Carol

Federal Register/Vol. 63, No. 137 /Friday, July 17, 1998/Proposed Rules 38511 and all deficiencies have been corrected, that are required for the closeout of the by RUS for at least two years from the the borrower: special equipment contract. The date of the engineer's contract closeout (i) Assembles and distributes the documents listed for RUS shall be certification.

documents listed in the following table retained by the borrower for inspection DOCUMENTS R!=OUIRED TO CLOSEOUT SPECIAL EQUIPMENT CONTRACTS RUS FORMS 397 AND 398 No. of copies prepared by RUS Form No. Description Form 397 Form 398 Distribution Contractor Engineer Contractor Engineer Borrower Contractor 238 .................... Construction or Equipment Contract ******************** (3) ******************** (3) (to RUS)

Amendment (If not previously sub-milted, send to RUS for approval.).

396 .. :................. Certificate of Completion-Special .................... 2 .................... .................... 1 1 Equipment Contract (Including In-stallation).

396a .................. Certificate of Completion-Special .................... .................... .................... 2 1 1 Equipment Contract (Not Including Installation).

744 .................... Certificate of Contractor and lndem- 1 ******************** .................... .................... 1 ....................

nity Agreement.

213 .................... Certificate (Buy American) ................. 1 .................... 1 ******************** 1 ....................

None ................. Report in writing, including all meas- 1 .................... .................... 1 1 ....................

urements and other information re-quired under Part II of the applica-ble specifications.

None ................. Set of maintenance recommenda- 1 .................... 1 .................... 1 ....................

lions for all equipment furnished under the contract.

(ii) Obtains certifications from the Form 773 contract is the date the Form of respiratory protection and other licensed engineer that the project and 773 contract is executed. controls to restrict internal exposure to all required documentation are (1) For outside plant *construction, the radioactive material. The proposed satisfactory and complete. Requirements limit is $500,000 or ten per cent (10%) amendments are intended to make these for this contract closeout certification of the borrower's previous calendar regulations more consistent with the are set forth in§ 1753.18. year's outside plant total construction, philosophy of controlling the sum of (iii) Submits copies of the engineer's whichever is greater. internal and external radiation certifications to RUS with the FRS (2) For central office equipment, the exposure, reflect current guidance on requesting the remaining funds on the limit is $500,000. respiratory protection from the contract. (3) For special equipment and American National Standards Institute (iv) Makes final payment in buildings, the limit is $250,000. (ANSI), and make the requirements less accordance with the payment terms of * * * *

• prescriptive without reducing worker the contract. 29. Appendices A through F are protection. The proposed amendments

27. In§ 1753.76, paragraph (a) is removed. would provide greater assurance that revised to read as follows: Dated: July 8, 1998. worker exposures will be maintained as Jill Long Thompson, low as is reasonably achievable

§ 1753.76 General. (ALARA) and that recent technological Under Secretary, Rural Development.

(a) This subpart implements and advances in respiratory protection

[FR Doc. 98-18759 Filed 7-16-98; 8:45 am] equipment and procedures are reflected explains the provisions of the Loan BILLING CODE 3410-15-P

.Documents setting forth the in NRC regulations and are thus clearly requirements and procedures to be approved for use by licensees.

followed by borrowers for minor DATES: Submit comments by September construction of telecommunications NUCLEAR REGULATORY 30, 1998. Comments received after this facilities using RUS loan funds. Terms COMMISSION date will be considered if it is practical used in this subpart are defined in to do so, but the Commission is able to 10 CFR Part 20

§ 1753.2. assure consideration only for comments

• RIN 3150-AF81 received on or before this date.

28. In § 1753.80, paragraph (b) is ADDRESSES: Send comments to:

Respiratory Protection and Controls revised to read as follows: Secretary, U.S. Nuclear Regulatory To Restrict Internal Exposures Commission, Washington, DC 20555-

§ 1753.80 Minor construction procedure. 0001, Attention: Rulemakings and AGENCY: Nuclear Regulatory

• * * *

• Commission. Adjudications Staff.

(b) RUS financing under Form 773 ACTION: Proposed rule. The NRC staff specifically requests contracts dated in the same calendar comment on whether the technical year is limited to the following amounts

SUMMARY

The Nuclear Regulatory aspects of the rule should be addressed for the following discrete categories of Commission (NRC) is proposing to through alternative approaches other minor construction. The date of the amend its regulations regarding the use than the proposed rule, such as a simple J

Docket No. PR-020 (63FR38511)

In the Matter of RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES DATED DATE ~F , TIT~E QR..[)l;SCRIPTIOf+J .OF COMMENT NO.

DOCKETED DOCUMENT DQCUMENT 07/14/98 07/13/98 Federal Register Notice - Proposed Rule 08/21/98 08/17/98 Comment of Integrated Environmental 1 Management, Inc. - submitted by Carol D. Berger, President and Brian A. Kelly, Chief Operations Officer 08/31/998 08/19/98 Comment of Department of 2 Commerce - National Institute of Standards & Technology - submitted by Lester A. Slaback, Jr.

09/15/98 09/10/98 Comment of BWX Technologies, Inc. 3

- submitted by Arne F. Olsen, Licensing Officer 09/16/98 09/14/98 Comment of Ching-tsen Bien 4 09/22/98 09/21/98 Comment of Minnesota Mining and 5 Manufacturing Company (3M) -

submitted by Ronald E. King, Regulatory Affairs Manager 09/23/98 09/21/98 Comment of OSRAM SYLVANIA 6 Products, Irie. - submitted by Carmen Venezia, Radiation Safety Officer 09/28/98 09/21/98 Comment of Wyoming Mining 7 Association - submitted by Marion Loomis, Executive Director 09/29/98 09/28/98 Comment of National Institute for 8 Occupational Safety and Health -

submitted by Paul A. Schulte, Ph.D.,

Director, Education and Information Division

"**)

DATED DATE OF TITL~'.OR oescRIPTION OF COMMENT NO; DOCKETED DOCUMENT DOCUMENT 09/29/98 09/28/98 Comment of Daniel J. Strom, Ph.D. 9 09/30/98 09/30/98 Comment of Michael J. Benjamin 10 10/01/98 09/30/98 Comment of Mallinckrodt, Inc. - 11 submitted by Ashok K. Dhar, Manager, Radiological Affairs 10/05/98 09/30/98 Comment of Virginia Power - 12 submitted by James H. McCarthy 10/05/989 10/01/98 Comment of Commonwealth Edison 13 Company - submitted by R. M. Krich, Vice President, Regulatory Services 10/08/98 09/30/98 Comment of TSI Incorporated - 14 submitted by Jeff Weed 10/09/98 10/05/98 Comment of ISEA, The Safety 15 Equipment Association - submitted by Janice Comer Bradley, Technical Director 10/19/98 10/09/98 Comment of Nuclear Energy Institute 16

- submitted by Lynnette Hendricks, Director, Plant Support, Nuclear Generation Division 10/28/98 10/22/98 Comment of John P. Hale 17 02/05/99 01/29/99 Comment of Department of Energy - 18 submitted by Joseph E. Fitzgerald, Jr., Deputy Assistant Secretary 09/30/99 09/30/99 Federal Register Notice - Final Rule 11/16/99 11/09/99 Comment of the Department of 19 Commerce - submitted by Lester A.

Slaback, Jr., Supervisory Health Physicist