ML20211N961
| ML20211N961 | |
| Person / Time | |
|---|---|
| Issue date: | 09/02/1999 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Vietticook A NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20211N938 | List: |
| References | |
| SECY-99-207-C, NUDOCS 9909130113 | |
| Download: ML20211N961 (25) | |
Text
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A F F I R M A T I O N. VOTE RESPONSE SHEET l
TO:
Annette Vietti-Cook, Secretary FROM:
COMMISSIONER MCGAFFIGAN
SUBJECT:
SECY-99-207 - FINAL RULE: " RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURES, 10 CFR PART 20" Approved Y
Disapproved Abstain Not Participating COMMENTS:
See attached comments.
x*
SIGNATURE dDU
'0 3, l9Ti DATE~
Entered on "AS" Yes N No
$0"20AksIEOU CORRESPONDENCE PDR 99 ()S\\ 36l(3
?
Commissioner McGaffigan's Comments on SECY-99-207 I approve publication of the final rule amending the 10 CFR Part 20 respiratory protection requirements, subject to the following comments and edits.
The staffs statements throughout SECY-99-207 and its attachraents that NRC ic adooting the American National Standards Institute's ANSI Standard Z88.2-1992, "American National Standard Practice for Respiratory Protection," are inexact. In fact, many of the provisions of ANSI Z88.2-1992 are being incorporated in the regulations ur regulatory guide, but not all. The staff should revise the Federal Reaister Notice (FRN) and all attachments to avoid the irnplication that NRC is adopting the voluntary consensus standard in full.
In future rulemaking packages where the staff recommends partially adopting a vol'unta y consensus standard, the staff should explicitly identify to the Commission all portions of the
' consensus standard that are not being adopted, and provide a justMcation why those portions of the technical standard are inconsistent with applicable law or otherwise impractical.
The staff should strengthen the justification on pages 19-20 of the FRN that addresses why a physician, as opposed to a licensed health care professional, must determine whether the user is medically fit to use respiratory protection equipment. The Occupational Safety and health Administration allows a licensed health care professional to make the determination, as the paper indicates, but ANSI Z88.2-1992 specifies that a physician shall make the determination.
Our final rule should follow the voluntary consensus standard. However, on the next revision to the ANSI standard, the staff should, encourage the ANSI Subcommittee to consider whether licensed health care professionals, such as occupational heath nurses, are qualified to make medical fitness determinations.
.The final rule now contains assigned protection factors (APFs) that are identical to ANSl's APFs, except for filtering facepiece disposables (e.g., dust masks) and suits. Thus, the staff should delete the text on page 22 of the FRN regarding differences between NRC's and ANSI's APFs (the third through fifth sentences in the top paragraph of page 22).
Additional edits to the FRN and all attachments are shown on the attached pages. I concur with Chairman Dicus' comments and suggested edits to the FRN. I also concur with Commissioner Diaz' comments.
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t 4 The Commissioners
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_ provided the pnmary technical basis for the proposed rulemaking published for public comment in July of 1998.
Eighteen letters of public comment were received on the proposed rule and eight letters of comment on the ursrt revision of Regulatory Guide 8.15 " Acceptable Programs for Respiratory Protection." Sec' don il of the attached Federal Register Notice discusses howihe public comments were resolved by the NRC staff.
DISCUBSION:
This revision to the respiratory protection requirements contained in Part 20 reaffirms the Commission's intent to apply ALARA pnnciples to the sum of extemal and intemal doses and to reduce the use of respirators when their use.may cause more risk. The use of process or e
3 engineering controls, decontamination of work areas, access control, and other procedures are s
stressed. The automatic use of respiratory protection devices, which tends to increase worker externa! Josa and stress, would be recuced correspondingly.
The final rule also recognizes new respiratory psotesction devices that have been proven effectnm, adopts new Assigned Protection Factors (APFs) based on ANSI determintions, and revises requirements for respiratory p otection procedures, such as testing, to reflect current bdusty good practice and to conform to new regulations publis by OSHA. The changes
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are believed by the staff to be a reduction of unnecessary regulatory burden that may save NRC licensees an estimated 1.5.million dollars per year. The rule is considerably less prescriptive while the staff believes that it will result in a reduction in risk to worker health and safety.
The amendments are described in detail in the attached Federal Register notice j
(Atudw.snt 1). A summary is provided here.
1, lhe rule clarifies that a respiratory protection program is required if a licensee issues respiratory protection equipment to limit the intake of radioactive material. Some licensees have misunderstood the intent of the existing rule and believe that a resphiery protection program is needed only if the licensee " takes credit" for the use of
.Whiitors in estimating dose.
2.
The rub makes extensive changes to Appendix A to 10 CFR Part 20. Appendix A lists the respirator types considered acceptable by the NRC and lists th4 Assigned Protection Factors (APFs) (i.e., appruved measures of respirator effectiveness). The current list is out of date. Some new and effeebve devices are not recognized in the Appendix and many of the APFs are no longer correct. The major changes to Appendix A, discussed in more detail in the Federal Register notice, are listed here.
Several footnotes that contain general programmatic requirements are moved to the body of the rule. Several are deleted because they are considered to be redundant with the National Institute of Occupational Safety and Health (NIOSH) certification requirement.
f in addition, the NRC regulation includes the Assigned Protection Factors (APFs)
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recommended by th* eneiwi National Standards Institute (ANSI) with some' modifications.
Y hemm, in radiological applicatiwhi, tv.,ing APFs to generate an estimate of intake of rariancave materials is an acceptable method to demonstrate compliance with NRC dose limits, APFs must be included in N requation. However, OSHA rules do not specify APFs because this section of the OSHA rules is sti9 under development.
The NRC regulations include dose limitation for radiation exposure with thejgaigd8'
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wwww.pt of keeping total dose As Low As is Reasonably Achievabi, (ALARA). OSHA does not
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address radiation hazards and dcos not include the ALARA concep Finally NRC requirements do sr.exe it clear that if an NRC licensee is using respiratory pidi CA,oo protect workers against non-mdiological his d., the OSHA requirements apply.
If the NRC has jurisdiction and is responrible for inspection, the MOU specifies that NRC will infocn the licensee and OSHA 4 die NP,C e i.uerves an unsafe condition relative to non-radiological hazards. For all of these r9asons, NRC believes it must have respiratory protection regulations in place, rather OSHA regulations.
Several commenters suggested endorsing ANSI gi.adance in the regulations such as ANSI 288.2-1992,"American National Starn!rJd ivi hespiratory 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 standard =. However, the ANSI standard does not specifically address radiological protecbon.
. In addition, the ANSI recommendations for general respirator usage are too prescriptive to be lik WJ as regulatory requirements given the Commission's intent to promulgate risk-informed and performance-based rules.
With changes to the pic,-:==i rule docussed he." "i CFR Part 20, Subpart H will be i
I consistent in almost all respects with ANSI guidance. The final Regulatory Guide 8.15, e
i 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 I
ANSI and in response to public comment, the NRC staff has chenged these APFs to 100.
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- it was suggested that Appendix A could be put into Regulatory Guide 8.15 so that I
changes could be made more easily as ANSI revised APFs. This suggestion is not accepted by.
+ 1he NRC staff because APFs may be used to generate estimates of dose of record from the intake of rudioactive material and as such should be regulatory requirements. Regulatory
- Guides provide descriptions of aWable programs, are guidance only, and cannot be enforced.
Several commenters suggested that the NRC terms and definitions should be consistent with those used by OSHA. The NRC staff agrees. Several OSHA terms and definitions have been added to 10 CFR Part 20 in this final rule and several proposed NRC definitions have i
been amended to be more consistent with OSHA terms.
i A commenter observed that 9 20.1703(c)(3) requires that respirators be tested for cperability 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 i
deleted. The NRC staff does not intend that user seal checks (fit checks) be quantitative nor I
that they be documented. User seal checks have been required by the NRC smce 1979 and are well known to the industry. Ucensee training programs describe the procedures and the procedures are subject to periodic licensee and NRC 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.
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intake." In effect, if a licensee determines that respiratory protection is not required to limit intake of radioective material and a respirator is used for some other reason. then the 5 20.1703 conditions are not applicable. However, in this case, other regulations would govem
&d will be.
f the use of respirators.. For example, if a worker requests a respirator,:: M.; gi./. :. nota 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
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(dust masks) would be little more thar brief instruction on the limitatons of the device arvi correct methods of use. NRC, as well as OSHA requirements for the use of tight 4itting, half or full-faceplace respirators are more extensive, including medica: evaluation.
A suggestion was made that 9 20.1703(d) should include instructing a wc;xer 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 NRC staff believe,a, 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 wnh auxiliary self-contained air supply for use during emergency entry into an unassessed environment. The NRC staff intends that Appendix A Section lil, Cornbination 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 NRC 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 made. between elastomeric half-masks with replaceable cartridges and those designed with the filter m,edium as an integral part of the face piece (e.g., disposable or reusable 10
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' provision clearly modifies information in Appendix A. The NRC staff believes it shouxi remain in l
the footnotes. With the restructuring of Appendix A, this information is found in new footcota c and f. More detailed discussion of the criteria for approval of sorbent cartridges against gases l
and vapors has been added to Regulatory Guide 8.15.
A comtrnotor suggested deleting proposed footnote e because the initial statement to the effect that filterbg facepieces may be used without medcal screening or fit testing applies to all tight fitting respirators. That is not the case. Fit testing and medical screening are 1
required for any respirator that is assigned a protechon factor (APF). Only disposable, filtering facepieces without elastomeric sealing surface and adjustable straps that do not have an APF can be used without medical screening. If the devices aie fit tested ir, Car to use an APF, then medical screening would also be required.
I i
This commentor suggested that the caution in the proposed footnote e to the effect that it is difficult to pedonn 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 nuriter of filtering.
facepiece respirators that do not have elastomeric sealing surfaces and at,1ustable straps. In most cases, it was very difficult for highly experienced respirator users to effectively perform a en.Q:l4e:nh ep;eee. rug:r.4ces G
user seal checQ the negative or positive pressure mode.
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l A commentor proposed deleting the last sentence in the final footnote i that wams against us ng SCBA in pressure demand or recirculating positive pressure modes if any outward leakage of breathing gas is perceived. This la e6 lmpoitent waming for use of these devices in emergencies or unassessed situations because lealmge could significantly reduce the expected duration of the air s'upply and thus sisy time. Premature exhaustion of the air-5fg 4
supply could result in serious injury or death M a worketin anhrea. This waming I
appropnately modifies the assigned protection factorsor this type of device.
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' The commentor questioned the wording in $ 20.1703(c)(3) that would exempt i
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 4
device 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 9 20.1703(c)(3).
It was observed that 9 20.1703(c)(6) does not specify that fit testing measures face seat 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 with ANSI. Also, the proposed requirement to fit test any tight-fitting, positive pressure, continuous flow and pressure demand devices to a fit factor 2 100 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 ' oor fit. The NRC staff p
believes that the OSHA recommended fit factor of 500 is not difficult to achieve and provides an additionalincrement of safety. The final rule reflects this change.
A commentor observed that Appendix A lists a positive pressure (PP) operational mode for some air purifying respirator types. This designation refers to " powered air purifying
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respirators (PAPRfand should be so designated. The NRC staff agrees and has made change.
A commentor suggested the use of 9ntake" or " dose from intemal radioactive material,"
instead of "intemal exposures," because there is some confusion regarding the meaning of that term. The NRC staff has reviewed the final rule and, whenever appropriate, more precise terminology has been used as suggested.
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stan&y penson to be in a high radiation area or otherwise be exposed to radiation or physiological stress. The NRC 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 picpcsed g 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 property maintain a seal, this restriction is not needed. The NRC staff observes that a fit test is not performed 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 oblects. materials, or substances, such as facial hair. or any other
/ conditions that interfere with the face - facaniaca ama! or valve funh. $$ :
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/ ira d ;%Q r the control of the respirator wearer, esent....
A commentor suggested elimination of the planned revision of NUREG-0041, " Manual of.
Respiratory Protection Against Airbome 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 piecedures unique to protectiori against airbome radioactive material will be addressed in detail if no other sources are available.
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The commentor 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 intnreddevice sht uld be used, such as a disposable, filtenng 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 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 i
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 protechon against airbome radioactive gases and
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vapors (e.g., radioiodine).' The commentor stated that the NRC should specify the same APF listed for partmulate filters for radioactive gases or vapors with good waming properties. The rwod NRC staff is aware thagradionuclides (e.g., airt>orne radioiodines) have poor to no waming
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properties. For this reason, the NRC 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.
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?.The established NRC pciiition, as described further in Reg. Guide 8.15, continues to be that a
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I 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 NRC staff is aware that serious
- injury and death can occur if a,T.m with certain medical conditions is permitted to use a i
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- + :1 A commentor observed that ANSI Z88.2-1992, does not ine'ude APFs for SCBA used in i
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' t'o 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 radiological hazards and not when chemical or other respiratory hazards exist.
A commentor suggested deletion of irntant smoke and isoamyl acetate as example of a user seal check because these are not checks that a user can perform without assistance. The NRC 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 assatance 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 operabihty. The NRC staff agrees and Reg. Guide 8.15 will be expanded to provide more guidance on accepted techniques.
It was suggested that more specificity regen;;,,g 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 NRC staff does not agree because respiratory programs should be site and work specrfic and the intent of revising the rule was to make it more
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perfonnance bassd. Considerable guidance on acceptable methods exists and is referenced in Reg. Guide 8.15 or NUREG-0041.
A commentor said that NRC should require use of the OSHA medical check questionnaire, orits equivalent. The NRC staff agrees that the OSHA questionnaire is an acwp2Ae 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 NRC 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 NRC staff believes that this issue is outside the scope of 10 CFR Part 20 and should be addressed between workers and licensee management.
A commentor suggested adding a definition for "Immediately Dangerous to Life or Health," IDLH. Subpart H of 10 CFR Part 20 provides program requirements for respiratory protection against airbome radioactive material. It would be extremely rare for airbome concentrations of radioactive material to reach IDLH levels. IDL H refers to industrial and toxic chemical hazards that NRC licensees must be alert to in compliance with OSHA regulations. It would be inappropriate for. NRC to suggest that airbome 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 dan 0erous atmosphere."
It was suggested that 6 20.1703(f) state that a sufficient number of standby rescue
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persons must bagvailable to provide effective emeroency remja. The NRC staff agrees and
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these words have been added.
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A commentor observed that the APFs specrfied by NRC in Appendix A are not in complete agreement with those recommended by ANSI. The difference for disposable filtering facepieces (dust masks) has been <*amaaed. /'--
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i Eight comment letters were received regarding the draft Reg. Guide 8.15. All of the suggested changes derived fern comments made on proposed Subpart H of 10 CFR 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 r*amaaed in this sechon.
Ill. Summary of Changes This final rule amends 9 20.1003, " Definitions", 99 20.1701 through 20.1704, adds
' 9,20.1705, and amends Appendix A to Part 20.
In $ 20.1003, the NRC is adding definitions for Air-purifying respirator, Assigned protection factor (APF), Atmosphere-supplying respirator, Demand respirator, Disposable respirator, Filtering facepiece (dust masic), Fit factor, Fit test, Helmet, Hood, Loose-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. These added definitions clarify the new regulations at $6 20.1701 through 20.1705.
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D Section 20.1703(c) is removed because it requires licensees to use only respiratory
' protechon 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 6 20.1703(a) and
- (b), this provision is redundant; The revisions of R'egulatory Guide 8.15 and NUREG-0041 i
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 writmg 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
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protechon program are o submit a program description during the license application,
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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.
f Section 20.1704(a) is revised to clarffy 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 airbome radioactive materials.
Appendix A to Part 20 " Assigned Protechon 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.
Foctnotes that are instructive or that facilitate implementation of the rule are being moved to i
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Regulatory Guide 8.15. Several footnotes are considered to be redundant in that they reiterate i
NIOSH certification criteria to be discussed in NUREG-0041 and are removed. Generic 29
accordance with 6 20.1703(b). Requirements for standby rescue persons apply to oper 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
'SCBA in demand open circuit and demand recirculating mode requires considerable caution O
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chance of'facepieco leakage when operating in the negative pressure mode is considerably higher than when operating in a positive pressure mode. This is espeaall critical for devices that could be mistakenly used in immediately dangerous to life and health (lDLH) areas during emergency situations. Although ANSI lists re!atively high APFs for these devices, they are not recommended by the NRC for use and acceptable attemative devices are
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readily available. Footnote h requires that controls be implemented to assure that these devices are not usedin IDLH areas.
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A specific statement is added in footnote f, to exclude radioactive noble gases from 4
consideration as an Inhalation hazard and advising that extemal (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 extemal dose can be found in 10 CFR 20.1502.
IV. lasue 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, 38
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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 reBable test information.
i (c) The licensee shallimplement and maintain a respiratory protectiori 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) Toshng 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 (i) Monitoring, including air sampling and bioassays; (ii) Supervision and training of respirator users; (iii) Fittesting; (iv) Respiratorselection; (v) Breathing air quality; (vi) Inventory and~ control; (vii) Storage, issuance, maintenance, repair, testing, and quality assurance of i
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 use'r is medically fit to use respiratory protecbon equipment; before o.
.The initial fitting of ace sealing respirator; j
(i) _
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o 1.
Statement of the Problem
. With the exception of the May 1991 revision to 10 CFR Part 20 that, among other things, required licensees to maintain the sum of intamal and extemal dose as low as is reasonably achievable (ALARA), the Nuclear Regulatory Commission (NRC) has not ma ntive I
technical changes in its regulation on the use of respiratory protection by scensees in
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- several decades, in the interim, the NRC has substantially revised regul to reflect new radiation ihvi.,ction recommendations with regard to primary dose limits and dosimetric models. The NRC has now prepared amendments to S"hnart H ("Rapiratory
_ Q ~. 6 Protection and Controls to Restrict Intemal Exposure") of 10 CFR Part 20 revisions tol ne Regulatory Guide 8.15, "Acc.pe bie Programs for Respiratory huwuun. NUREG-0041 (Rev.
N45 *L 1), " Manual of Respiratory Protection Against Airbome Radioactive Materials" is expected to be published following the final rule. These changes reaffirm the Commission's intention to reduce the urr+Ny use of respirators when their use does not optimize the sum of the Deep Dose Equivalent (DDE) and the Committed Effective Dose Equivalent (CEDE), or Total Effective Dose Equivalent (TEDE). Instead of relying on respiratory protection devices, licensees are required to consider the use of process and engineering controls, filtered ventilation systems, decontamination of work areas, control of access to radiological areas, limitation of exposure time, and use of other types of exposure conhuis. The new regulations and guidance generally endorse the use of ANSI standard Z88.2-1992, 'American National Standard Practice for
' Respiratory Protection," with a few exceptions. This ANSI standard represents the most current g.M industry guidance for the use of respiratory protection when other ALARA-based attematives P
are notW. The new NRC standards are designed to be consistent with the new OSHA
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i regulations at 29 CFR Parts 1910 and 1926. While licensees are required by Part 20 to use one or more of the attemative control practices discussed above (i.e., avoid use of respirators in wppoorcircumstances), respirator use would be permitted if the practice will help to optimize the v/
I TEDE. Respirators might also be used in situations where:
(1) non-radioactive nuisance dust.is present in the work area, or (2),
workers and/or the health physics department are in a relatively short-term Isaming process or making a transition from routine use of respirators, or (3) the use of certain respiratory protection devices reduces heat stress on workers, or (4) they are used as contamination control devices in high contamination but relatively low airbome radioactivity areas with the potential for significant resuspension, or (5) a worker requests a respirator when the licensee has determined that use of a respirator is not needed, or (6) they serve as a precautionary measure in which there is a large uncertainty in the magnitude of the projected concentrations of alibome material to which workers might be exposed.
In all cases, respirators should be selected to have the least. possible impact on worker function
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(e.g., stress from heat, breathing resistance, ability to see and communicate). These and other options are permitted by the rule change, which also revises the current table of tespirator assigned protection factors (APFs) to reflect the latest information and experience available.
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1-6 20.1703(b). While these changes may be justified on the basis of improved personnel safety underlow temperature conditions, the potential impacts are addressed in the following section.
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(3)
The deletion of f 20.1703(d) removes the requirement to notify the NRC region in writing 30 days before the first use of respiratory protection. Removing a requirement for duplication of reporting is expected to result in a small r' eduction in regulatory burden for both the NRC and some licensees, and is addressed below in the value/ impact analysis.
(4)
"fhe part of Footnote g to Table 1 of Appendix A which currently precludes the use of hall mask facepiece air purifying respirators for protection against plutonium or other high-toxicity materials is deleted. Half-mask respirators, if property fitted, maintained and wom, provide adequate protection against plutonium if used within the limitations stated in the NIOSH approval and in the rule. The NRC has not identified any current technical or scientific basis for such a prohibition, and deletion may result in some reduction in regulatory burden because the change should increase operational flexibility. This is evaluated further in the value/ impact analysis.
-(5)
. The addition of single use, disposable respiratory protection devices (e.g., dust masks) to the proposed Appendix A recognizes the utility of d!g-b!es and formally permits their use with no protective credit allowed. These devices have minimal physiologicalimpact, o.nd
[
accommodate workers who request respirators (some States have OSHA rules which thquire providing respirators to workers who request themRRC does not require fit testing or medical./
acreening and although not quantifiable, they have txRFn shown to provide some protection againstintake. Although many of these devices cannot be tested for a measurable seal, licensees should train workers in their use and limitations. Use of such devices by persons desiring but not requiring respiratory protection (i.e., because of engineered control systems, or other factors) could result in substantial savings, and will be addressed further in the value/ impact analysis.
(6)
Permitting the use of " Reusable-Disposable' half-mask facepiece respirators, 1
represents an acknowledgment of new developments in half-mask respiratory devices. This change permits increased use of these devices by licensees, and less use of more expensive respiratory piswction by licensees. Reusable, reusable-disposable, or maintenance-free respiratory devices for use with radioactive material are relatively new variations on half-mask facepiece respirators. In these devices, the filter medium is an integral part of the facepiece and is not replaceable. The face-to-facepiece seal area is generally enhanced by the
- application of plastic or rubber. The devices have at least two adjustable suspension straps.
These devices are acceptable to the NRC and are considered half masks as long as the following criteria are met: they are made of high efficiency filter media, they can be fit tested, and a fit check can be property perfomied by tte wearer upon donning. Since, under the proposed rule, these devices can replace more expensive respirators (primarily full facepiece respirators) their use has the potential for reducing the cost of the licensee's respiratory protection program. The use of such devices is addressed further in the value/ impact analysis.
(7)
The revision of Appendix A APF from 50 to 100 for air purifying, full face masks operating in negative pressure mode is consistent with ANSI Z88.2-1992 recommendations, and may result in increased flexibility (and reduced regulatory burden) for some licensees. This is addressed further in the value/irnpact analysis.
3 O
9 W,s sont a
%eg k4e-.
is known from dosimetry reports th the existing Iratory protection rules as implemented are effective in protectina -- '. molovees m inhalation exposure to airbome radioactive
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r materials, and thafthese rule changes constitute of respiratory protection] Although the changes marginally add to worker safety and htsalth, there is no attempt to quantify added value
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or impact to employee health. Rather, the values and impacts of the changes are all related to potential saving or added cost in operating effective respirator programs at licensee sites. This analysis considers both power reactor licensees and materials licensees, and impacts and benefits of the new rules on respiratory protection programs are considered to be the same for l
both types of heensees. In making the estimates, the following general assumptions are made:
There are about 250 licensees affected by the changes;.100 power reactor licensees and 150 nuclear materials licensees Labor cost is $145/hr for a power reactor licensee and $116/hr for other licensees NRC labor cost is estimated to be $70thr Approximately 200,000 workers at licensee sites (primarily power reactors) are currently monitored ior radiation exposure; about half of the monitored workers are exposed to a measurable dose; of those exposed to a measurable dose, about 10 percent /yr may use respirators (20,000)
The most predominantly used respirators are the full mask negative pressure (NP) respirator, full mask positive pressure (PP) respirator or powered air-purifying respirator (PAPR), and full mask pressure demand (PD) Self Contained Breathing Apparatus (SCBA); no more than 10 percent currently use half-mask devices These assumptions are made based on NRC data and on information obtained from industry experts on respiratory protection, licensees, and the Nuclear Energy Institute located in Washington, DC. The estimates and specific rationale used are presented below item by item following the same sequential order as the discussion in Section 4. A summary of the overall value and impact is presented at the end of this section.
(1)
Elimination of Policy Statements This change will save licensees the cost of preparing policy statements and also save NRC inapdm staff from reviewing policy statements. It is assumed that about three licensees per year (one reactor licensee and two non-reactor licensees) would have prepared new policy statements in the future. Assuming that it would take 2.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> to prepare policy statements for a heensee, the cost saving per year would be:
($145/hr x 2.5 hr/ licensee x 1 licensee) + ($116/hr x 2.5 hr/ licensee x 2 licensees) ~
$1,000 Each licensee would also save the cost of an annual review of its policy statement. Assuming
' O.25 hr for each review, for 250 licensees (100 reactor licensees and 150 non-reactor licensees), the annual saving would be:
5
l could save substantial costs to licensees (especially power reactor licensees) with no reduction in worker safety.
Respirator programs currently cost about $245 per employee per year for a reactor licensee and $216 per employee per year for a non-reactor licensee (assuming 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of training and fit testing plus $100 for niedical examination). Because almost all respirator use among NRC licensees are for reactor operations, non-reactor licensees can be ignored in the approximation.
This does not include the costs for respirators,' replacement due to wear and tear, replacement of filters, or cleaning and maintenance.
Currently, it is estimated that there are about 1,000 respirator uses/ reactor-year, primarily
' during maintenance and refueling, or about 100,000 uses peryear in the U.S. This number has probably gone down considerably, but data on the change is not available. It is assumed that-about 90 percent of all respirators with APFs greater than 1.0 are full-face piece respirators (APF = 50), with the remaining 10 percent, half-face mask respirators (APF = 10). It is further estimated that of all these applications, only about 10 percent require (based on ALARA considerations) use of respirators with APFs greater than one (but less than 10), while the remaining 90 percent of uses coulq p satisfied by a d!=p<wahle respirator (no allowed protection factor). Therefore, unde aw rule, about 90,000 traditional respirator uses could be replaced by disposables each year.
uming 40 percent of all half or full facepiece respirator l
uses would be replaced by disposable respirators (40,000 per year, averaged over several years), the new rule would replace about 40,000 traditional respirator uses each year.
Assuming the current industry maintains on the order of 500 respirators at each plant (50,000 respirators) which are used about 100,000 times per year, there would be about two uses per respirator per year.
Because of radiation protection concems about contaminating the inside of respirators when
' they are removed after wear in contaminated environments, and worker's fears of breathing cold bacteria, or flu or AIDS viruses from used filters (some expired air will always exit through the filters and sneezing could spray a mist on them), industry generally uses each respirator only once before it is recycled for cleaning and filter replacement.
Further, assuming full face-piece and half-mask respirators last from 5 - 10 years (7.5 years on average) before being replaced, licensees would replace 50,000 respirators /7.5 years =
6,670 respirators per year. If these respirators were replaced by traditional respirators, the cost j
for half-mask ($25 each) and full-face mask ($150 each) respirators would be:
[($25 x 0.1) + ($150 x 0.9)] x 6,670 = $917,125/ year
- The cost of replacing these traditional devices by disposable masks would be:
l 0.4 x 100,000 masks /yr x $0.8/ mask = $32,000/ year h
- (La., the not savings would be about $885,125/ year)
Assuming each worker uses a respirator two times per year, about 20,000 workers x 0.4 =
8,000. workers would be using disposable masks each year for the first time under the new rule.
- Assuming training on use of the new diapamahle respirators takes 0.2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> / worker, the training costs would be:
8
8
$145/ worker-hr x 0.2 hour2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x 8,000 workers / year = $232,000/ year For traditional respirator uses, if 5 percent of the work force is replaced each year, there would be about 1,000 new workers to train each year. Under the current regulations, that training cost
. would be:
x
$145/ worker x 0.2 hour2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />sy,000 workers = $29,000/ year
/
Maintenance costs for disposable masks would be zero. However, the maintenance costs for traditional respirators would be substantial for the 40,000 uses each year which could la avoided by using Wie masks.- Assuming only 5 minutes per mask for cleaning and replacement of the filter (s) and bagging, the costs would be:
40,000 uses/ year x 5/60 hr/use x $145/hr = $483,300/ year The cost of replacing the filter (s) on traditional masks would be:
~ 40,000 uses/ year x $7/use = $280,000/ year Thus, the total cost for traditional respirators would be about $1.7 million/ year
- New procedures would only be required if disposable masks were to be used, the cost for all operating reactors, assuming 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> of preparation per plant, would be:
2 hrs / plant x 100 plants x $145/hr = $29,000 the first year only i
(or $6,000/ year over a period of 5 years)
Cost Savings From Permitting Use of Disposables Cost of Using Traditional Masks Cost of Change to Disp-b!es Replacing wom-out or damaged 917K Cost of disp-bles 32K hatt or full-face respirators Training new users of 29K-Training on use of 232K traditional masks new disp-bles 4
Respirator Maintenance 480K Cost of writing new 6K prWures
~ Filter Replacement 280K Total 1706K-Total 270K Thus the potential savings from permitting the use of disposables is about $1,436K.
Permitting the Use of ' Reusable-Di -b!a' Half-mask F$cepiece Respirators (6)
?
At the present time, essentially no power reactor licensees are using talf-mask respirators in the NP mode (APF = 10). Current NRC guidance discourages the use of such devices as part 9
4
i o
of licensed activities because they must be checked for fit with imtant smoke each time they are put on. Thus, licensees typically use a more expensive full facepiece respirator in the NP mode
' with an APF = 50, because they are not required to perform irritant smoke tests each time those devices are donned. Under the new rule change that requirement would be removed for half-masks, and licensees would have an opportunity to replace. current full facepiece respirators with half-mask disposable or reusable-disposable respirators.
One of the newest types of half-face mask devices approved by NIOSH is the " reusable-disposable" half-mask respirator. These devices are substantially less costly than current half-or full-face masks and do not require any maintenance program, since they are simply discarded when wearers have completed their work. Thus, while less costly to purchase 4
and maintain than full face-mask devices, the costs of new reusable-disposable facepiece
' respirators would mount up quickly under periods of heavy use. Thus, the value must be compared with the lifetime cost per use of the respiratory devices they might replace. Because the use of these half-mask respirators would require training and procedures comparable to current respirators, there are no expected cost reductions associated with their use except the initial purchase costs relative to the cost of maintaining and replacing wom-out half an$ full-face 3
respirators. Because these respiratory devices will not be useful for as long as curren3more
/
, expensive full-or half-mask facepiece respirators (with an accepted maintenance program), the cost of replacing some part of the currently used, more costly facepieces should also be considered in the cost analysis for the proposed rule.
It is assumed that about 10 percent of all traditional respirators in use are half-rnask devices with an APF = 10; that means that about 0.1 x 50,000 = 5,000 of these devices might be used per year. If, as above, they are used about 20 times per year, cost $25 each, and last about 7.5 years on average, replacement costs are about:
$25/ mask / 7.5 year x 5,000 uses/ year = $16,650/ year Cleaning cocts for these traditional respirators, using the same assumptions as in 6) above, would be:
5,000 uses/ year x 5/60 hr/use x $145/hr = $60,417/ year Filter replacement costs at about $7 per mask would be about:
5,000 uses/ year x $7/use = $35,000/ year The cost of reusable /dispe!e respirators is on the order of $7 (or less) each. it is assumed that they would also be used only once before disposal for each time an APF greater than one is required. Thus, annual costs of using these devices in place of traditional respirators would be:
5,000 uses/ year x, $7/ device = $35,000/ year 10
ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT ON AMENDMENTS OF 10 CFR PART 20, SECTION 20.1003, SUBPART H " RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURE,' AND APPENDIX A ALAN K. ROECKLEIN OFFICE OF NUCLEAR REGULATORY RESEARCH U.S. NUCLEAR REGULATORY COMMISSION February,1999 i
- 1. The Action The Nuclear Regulatory Commission is amending its regulation's regarding respiratory protection to make these regulations more consistent with the philosophy of controlling the sum of intemal and extemal radiation exposure and to incorporate current and.new guidance on respiratory protection from the American National Standards Institute (ANSI). The amendment would assure that recent technological. advances in respiratory protection and devices are incorporated into NRC regulations and are available for use by NRC licensees.
The amendments focus on technical and procedural improvements'in the use of respiratory protection devices. The changes recognize new devices that have been proven to be usefulin protecting workers and revise (Ass ned Protection Factors (APFs) used to f
estimate the degree of protection afforded workers by respirators.
1 f
%,t.,
y UNITED STATES i
g
}
NUCLEAR REGULATORY COMMISSION o
WASHINGTON, D.C. sceeHoot The Her.Oret,le Joe L Barton Chairman, Subcommittee on Energy Committee on Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
l Enclosed for the information of the Subcommittee are copies of a Press Release and a final 1
amendment to 10 CFR Part 20 dealing with respiratory protection and other controls to restrict intemal exposure of radiation workers. The amendment will be published in the Federal Register. The new rules will become effective 120 days from the date of pubiication.
i pata These amendments are.%on guidance developed by the American National Standards Institute and are consistent with new respiratory protection regulations published recently by the h==+ianal Safety and Health Administration (OSHA). These amendments provide greater assurance that recent technological advances in respiratory action equipment and procedures are reflected in NRC regulations, and that worke xposures will be maintained as
/.
Iow as is reasonably achievable.
The rules enhance worker protection, establish a less prescriptive framework and are estimated to reduce unnecessary licensee burden by about $1.5 million per year with no reduction in worker health or safety. The Commission's rule is consistent with the general mandate of the Technology Transfer and Advancement Act of 1995 (Public Law 104-113) to utilize consensus standards.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
1.- Federal Register Notice
- 2. Press Release cc: Representative. Ralph M. Hall
?
NRC ISSUES FINAL REVISIONS TO REGULATIONS ON RESPIRATORY PROTECTION 1
The Nuclear Regulatory Commission (NRC) is amending its regulations goveming the use of respiratory protection equipmentand other controls to restrict internal exposure.
The revised rules provide greater assurance that workers' radiation exposures will be maintained as low as is reasonably achievable and approve for licensee use advances in respiratory protection equipment and procedures. The new rules are more performance based,'
i more flexible and easier to implement. The NRC believes the new rules will save licensees about $1.5 million per year, with no reduction in worker health and safety.
g { 4Q,
^
When the Commission's overall radiation protection regulations were significantly kuA m e raaim 3q9l7 chL revised in Mthe rules for respiratory protection were not similarly revised because t o n 5/a l/91.
American National Standards institute (ANSI) was working on consensus guidance in this area.
The ANSI guidance,"American National Standard Practice for Respiratory Protection,"is now 1
available and is essentially the technical basis for this rule. The Commission's rule is consistent with the general mandate of the Technology Transfer and Advancement Act of 1995 (Public Law 104-113) to utilize consensus standards. The new rules are also consistent with new
(
l respiratory protection regulations published recently by the Occupational Safety and Health j
l Administration (OSHA).
The changes emphasize the use df process or engineering controls, decontamination of work areas, access controls, and other procedures instead of the use of respiratory protection devices, which tend to increase external radiation doses and worker stress.
' The rules also recognize new respiratory protection devices that have been proven effective, discourage the use of other devices that are now considered less effective based on field tests, and revise requ!rements for respiratory protection procedures such as testing to evaluate the fit'of a respirator on a particularindividual.'
-