ML20011B185
| ML20011B185 | |
| Person / Time | |
|---|---|
| Issue date: | 05/25/1978 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| Shared Package | |
| ML20011B132 | List:
|
| References | |
| FOIA-81-303, TASK-CC, TASK-SE SECY-78-278, NUDOCS 8112040385 | |
| Download: ML20011B185 (54) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION O
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CONSENT CALEND AR ITEM
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For:
The Commissioners From:
Rcbert B. Mincque, Director, Office of Standards Development b-b
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Executive Director for Operations Thru:
v AMENDMENT TO 10 CFR PART 20 ON PERSCNNEL MCNITORING RE?CRTS
Subject:
To cotain Commission approval to publisn amencments to 10 CFR Purcose:
Part 20 in effective form.
Catacorv:
This paper covers a minor policy question.
Whether the Commission should extend to all NRC licensees Issue:
requirements for sucmission of personnel monitoring reports which currently apoly to only four categories of licensees.
Decision Criteria:
1.
Availability of cersonrel monitoring data required for an effective regulatory program.
2.
Minimum cost anc burcen on licensees.
r :eral regula :c, 3.
" nimum " bureaucratic red tape" in e
agencies.
Alternatives:
1.
Retain existing reporting requirements applicable to only four categories of licensees.
2.
Pursue other means of obtaining exposure data.
3.
Extend the requirements for annual reports (S 20.407) to all NRC licensees, retaining the existing application of requirements for termination reports ($ 20.408) to four categories of licensees.
These alternatives are discussed in further detail in Enclo-sure "E", "Value/ Impact Assessment Containing Report Justifi-cation Analysis."
Contact:
. alter S. Cool W
Ext. 443-6920 l
8112040385 810902 l
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The Commissioners 2
The Commission approved publication of a notice of proposed Discussion:
rule making after consider 3 tion of SECY-75-98 in Policy Ses-sion 75-20 on April 24, 1975.
Because of questions that subsequently arose regarding the value and impact of the prcoosed amendment, the staff, with Commission approval, requested licensees to submit exposure and cost data for 1975 on a voluntary basis. Only about 14% of the licensees responded.
The cost was found to be small, averaging about $26 per year The staff found that the exposure experience of per licensee.
the maiority of licensees is not represented by the four categories of licensees currently required to report pursuant to 5 20.407, and found the voluntary data very useful in evaluating the effectiveness of our operational regulatory It is evident to the staff that if such data could program.
be obtained on a regular basis from all licensees, the data would provide a better basis for staff recommendations to the Commission regarding occupational health protection regulations.
This recommended amendment will be discussed by the staff in the context of the overall NRC program for occupational health protection at a Cc :ission policy session.
A Commission Policy paper, " Reduction in Risks Associated With Occupational Radiation Exposuras in NRC-Licensad Activities," scheduled for transmittal to the Commission in May will provide the principal basis of discussion at that briefing session.
In the prepara-tion of the Commission paper, the exposure data submitted pursuant to $ 20.407 are proving to be particularly important in developing and evaluating regulatory alternatives for reducing occupational risks at various types of licensed establishments. The staff has been limited in its examination of alternatives by the availability of data on the. licensees that are not required to report exposure data.
The one-time, voluntary data are not considered to be sufficiently represen-tative to serve as a basis for such determinations.
The notice of proposed rule making was published in the Federal Register on May 30, 1975 (40 FR 23478), and provided a period of 45 days for public comment.
Copies of the notice of pro-posed rule making were sent to all licensees (about 8,200) by letter dated June 2, 1975.
A total of only 36 letters was received in response to the notice of proposed rule making.
Of these, 12 stated specific Two of opposition to issuance of the rule in effective form.
e The Commissioners 3
the letters were not comments but, rather, acknowledged receipt of the notice of proposed rule making or questioned the inter-pretation of the existing rule.
Two letters reflected misun-derstanding of the proposed amendment to 9 20.408 (no change in application of the requirement for termination reports).
Twenty of the letters favored the proposed amendments, many of them suggested minor changes.
Included among these favorable responses were strong endorsements for proceeding with issuance of the proposed amendment from the Environmental Protection agency and the Oil, Chemical, and Atomic Workers International Union. The more prevalent reasons for opposing the proposed amendments were (1) that burden on the respondents was not justified by benefit and (2) that because of diversity of program, use of both licensed and unlicensed sources, and technical differences introduced by personnel monitoring devices themselves and the variations in their application, the Commission would be unable to obtain valid data from the reporting requirement. The commenters are listed, the comments 4
abstracted, and staff response provided in Enclosure "0".
4 In view of the comments that raised questions regarding the value and impact of the proposed amendment, the staff sought and obtained Commission approval to solicit, as a voluntary, one-time action, the personnel exposure experience of all specific licensees for 1975 (SECY-76-266 dated May 11,1976).
Necessary GAO approval was obtained and the request was trans-mitted to licensees by letter of August 25, 1976.
Licensees already required to report pursuant to S 20.407 were not requested to submit the monitoring data again.
There were 1,179 responses to the request.
Reports were received from 1,175 out of 8,221 (14%) materials licensees in 40 out of 53 categories.
There were responses from three research reactor licensees and one test reactor licensee.
Data were submitted for 50,112 monitored individuals'; 20,992 (41.9%) of thefa individuals were reported to have received measurable doses that summed to 4,925 man-rems.
That is an average of 0.1 rem per monitored individual and an average of 0.23 rem per individual with measurable exposure.
If the data are extrapolated for the categories represented, assuming that the fraction of licensees not reporting is comparable in number of workers and exposure experience,- a total of 245,000 individuals would have been monitored and a total of 22,900 man-rems would have been received.
The detailed data have been made available in NUREG form (see Enclosure "F").
25, 1976, letter also invited licensees to provide The August an estimate of their effort (1) in man-hours, and (2) total l
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t The Commissioners 4
cost in preparing the statistical summary report of their personnel monitoring data.
The distributions of 172 responses regarding man-hours and 125 responses regarding cost indicate a median commitment of 2.75 minutes or 50.65 per monitored individual.
These estimates were used in preparing the "Value/
Impact Assessment Containing Report Justification Analysis" set fortn as Enclosure "E" to this paper.
However, these estimates were provided by licensees who had never before prepared such an annual report.
The staff believes that the c st incurred under an en-gcing reperting requirement would be lower than the values presented.
Commercial dosimetry services offer to prepare conputerized annual reports free or for a very small fee regardless of the number of individuals moni-tored by the customer.
The staff is aware of the technical problems associated with personnel monitoring devices and programs, the diversity of programs conducted by licensees, and that many individuals are involved in work with X-ray and radionuclides that are not subject to NRC regulatory authority.* However, the staff is convinced, based on nine years of experienca with the four categories of licensees under existing i 20.407 and the 1975 cata voluntarily submitted by "otner" licensees, that valid comparisons can be mace among types of licensees and among licensees within a given type.
The exposure data are needed to assess the collective (man-rems) dose from given types of licensed activities and the total from all NRC-licensed activi-ties.
Such information is needed by the NRC staff to assess the effectiveness of current regulatory strategy and activities and to determine the need for future activities.
Following the trends in occupational radiation exposures permits the NRC staff to maintain awareness of changes in the total radiation burden from a given type of licensed activity and to be able to estimate the total occupational radiation dose resulting from all NRC licensed activities.
It also' permits some assessment of the degree of radiation protection efficiency that is being ' main-tained.
In summary, exposure data provide the principal basis from which the staff assesses the effectiveness of the NRC regulatory strategy for occupational exposure risk reduction and for recommending changes to that strategy.
It should be noted that the NRC staff also believes that licensees need to Licensees are required by 5 20.l(b) to control the possession, use and transfer of licensed material in such a manner that exposure to such material and to other unlicensed sources of radiation in the possession of the licensee, does not exceed the radiation protection standards in 10 CFR Part 20.
It is notable that a number of the commenters indicate that exposures being received by individuals working with unlicensed sources of radiation are significantly higher than exposures associated with the use of licensed material.
The Commissioners 5
develop this information for their own evaluation and action in control and direction of their radiation safety programs.
Note that the needs for statistical summaries of personnel moni-toring data discussed in this paper do not include use for purposes-of epidemiological studies.
Comments were received in opposition to the notice of proposed rule making in this present action and with respect to actions proposed by the former AEC, because the com-menters thought that the monitoring data would be used directly for epidemiologic:1 purposas.
The MRC staff is in the initia1 stages of planning an epidemiological study to assess low-level radiation effects.
Some data useful for such a study are already repcrted to NRC, and complete data are available from licensees.
If, at some future time, additional reporting for epidemiologcal purposes is needed, further amendments to the regulations will be proposed.
The personnel monitoring data already received provide a base that has been used to develop a variety of value/ impact analy-The "hard" data from additional categories of licensees ses.
would be used by the staff and the Commission in place of the "seft" voluntary data for 1975 or estimates to determine the types and numbers of licensees and the number of individuals tnat would be affected by proposed rule changes intencea to increase the protection provided for workers in the nuclear industry.
They may be used as one indicator in the assignment of priorities for inspection and enforcement action.
The data are being used by the staff in.the identification of situations to be studied further in order that regulations and regulatory guides can be developed on action that should be taken in the design and operation of licensed facilities to keep occupa-tional radiation exposures as low as is reasonably achievable.
For example, it is relevant to compare the potential increase in coll.ective radiation dose, that is, occupational dose plus dose to the general population, when considering the controls to be imposed on the release of radioactive material in efflu-ents to unrestricted areas.
As another example, the personnel monitoring data are used to establish pricrities with respect to the need for regulatory attention by permitting-a perspec-tive to be drawn through consideration of the collective dose in addition to individual and average doses.
In some cases, more regulatory attention may be required for licensees with larger collective doses than for licensees with larger indi-vidual doses.
For example, the data for 1975 for medical licensees indicates a collective dose approaching 13,500 l
man-rems, while the average dose for the 95,700 individuals t
(including a high percentage of women of reproductive capacity) 1 is only 0.14 rem.
If the collective dose is doubled to account for Agreement State licensees, it becomes evident that medica!
occupational dose (not including diagnostic or therapeutic doses to patients) exceeds that from any other category of
i The Commissioners 6
licensees.
(See Tables 2 and 4, and Figure 2 of Enclosure "F".)
~
Section 20.408, " Reports of personnel exposure on termination of employment of work", would be amended only to (1) change the recipient of the reports from the Director of Inspection and Enforcement to the Director of Management and Program Analysis and (2) specify the same four categories of licensees presently required to submit re' ports of individual exposure to radiation and radioactive material upon termination of employment or. work assignment in their facilities.
Those cate-nories are currently set out in ! 20.407(a) and incorporated in 6 20.408 by reference.
Recommendation:
That the Commission:
(a) Acorove publication of the amendments to 10 CFR Part 20 set out in Enclosure "A".
(b) Note 1.
The amendment to 10 CFR Part 20 set out in Enclosure "A" would be effective 75 days after publication in the Federal Register; 2.
The Subcommittee on "uclear Regulat.icn of the Senate Committee on Environment and Public Work % the. _
Subcommittee on Energy and the Environment of the House Committee on Interior and Insular Affairs, and the Subcommittee on Energy & Power of the House Committee
~
~~h !nterstate & Foreign Cgmmerce will be informed of this oact<on by letter such as tnclosure "B";
3.
An appropriate public announcement, sucn as Enclo-sure "C", will be issued upon filing of the notice of rule making with the Office of the Federal Register;
^
4.
General Accounting Office review of the reporting requirement will be obtained after Commission approval of the amendments but prior to making the rule effec-tive.
A "Value/ Impact Assessment Containing Report Justification Analysis" is set forth in Enclosure "E";
5.
Pursuant to 6 51.5(d)(3) of Part 51 of the Commis-sion's regulations, neither an environmental impact statement nor a negative declaration need be prepared in connection with these amendments since they impose only reporting requirements and thus are insignificant from the standpoint of environmental impact; and
c' l
The Commissioners 7
6.
The staff considers the solicitation, evaluation,
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and publication of the personnel monitoring data for 1975 to satisfy the Commission's directive in Policy Session 75-20, April 24, 1975, during discussion of SECY-75-98,,regarding the review of one year's data to evaluate the need for and use of personnel moni-toring information.
7.
These amendments are not considered to be matters'of basic comoatibility between NRC and Agreement State regulations.
Coordination:
The Office of the Executive Legal Director has no legal obiec-tions.
The Offices of Administration, Nuclear Reactor Regula,
tion, Nuclear Material Safety and Safeguards, Nuclear Regula-tory Research, Inspection and Enforcement, State Programs, Gen-eral Counsel and Policy Evaluation concur in the recommendation of this paper.
The Office of Public Affairs prepared the draft public announcement.
The Paperwork Reduction Subgroup has reviewed the Value/ Impact Assessment Containing Report Justiff.
cation Analysis (Enclosure "E") and approved the reporting requirs ent.
Sunshine 2.:t Recommendation:
If a Commission session is necessary, it is recommended that this paper be considered in an open meeting.
OGC and OPE concur.
, l, ll1 o!, lb. -c=. w.
Robert B. Minogue, Director Office of Standards Development
Enclosures:
"A" - Notice of Rule Making "B" - Draft Letter to Congressional Committees "C" - Draft Public Announcement "D" - Abstracts of Comments and Staff
Response
- "E" - Value/ Impact Assessment Containing Report Justification Analysis "F" - NUREG-0419, " Occupational Radiation Exposure at NRC Licensed Facilities 1975" "G" - NMSS and NRR memoranda
- cy available in the Office of the Secretary O
8 Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Thursday, June 8, 1978.
Commission Staff Office comments, if any, should be submitted to tne Commissioners NLT June 2,1978, with an information copy to the Office If the paper is of such a nature that it. requires of the Secretary.
additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
This paper is tentatively scheduled for affirmation at an Open Meeting during the Week of June 12, 1978.
Please refer to the appropriate Weekly Commission Schedule, wnen published, for a specific date and time.
DISTRIBUTION:
Commissioners Commission Staff Offices Exec. Dir. for Opers.
Regional Offices Secretariat
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t.
Enclosure A Notice of Rule Making e*
O e.
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1 1
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Title 10 - Energy CHAPTER I - NUCLEAR REGULATORY COMMISSION PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION Personnel Monitoring Reports AGENCY:
U.S. Nuclear Regulatory Commission 4
ACTION:
Final Rule.
SUMMARY
The Nuclear Regulatory Commission is amending its regula-tions to extend to all NRC specific licens,ees the requirement for submission of an annual statistical summary report on radiation exposure of workers.
The existing requirement applies only to four categories of licensees that were considered to involve the greatest potential for significant occupational exposures, i.'e., nuclear power reactors, ind'ustrial radiographers, nuclear fuel processors and reprocessors, and certain large commercial suppliers of byproduct materials.
The amendments do not involve any changes in the require-ments for the provision and use of personnel monitoring equipment or the records of personnel monitoring data that must be kept.
The changes relate solely to reporting data already being recorded.
The regulation requiring certain reports on termination of employment or work assignment in the facilities of four categories of licensees is being amended only to change the recipient of the reports and to specify the same four categories of licensees.
1 Enclosure "A"
l l
Those categories are currently set out in another section and incorporated by reference in the section requiring termination reports.
EFFECTIVE DATE:
(A date will be inserted designating 75 days after publication in the FEDERAL REGISTER)
NOTE: The Nuclear Regulatory Commission has submitted this rule to the Comptroller General for such reviews as may be appropriate under.
the Federal Reports Act, as amended, 44 U.S.C. 3512.
The date on which the reporting, requirement of this rule becomes effective, unless advised to the contrary, accordingly ref1'ects inclusion of the 45-day period which that statute allows for such review (44 U.S.C. 3512(c)(2)).
FOR FURTHER Ii(FORMATION CONTACT:
Mr. Walter S. Cool, Office of Standards Development, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555 (phone 301-443-6920).
SUPLEMENTARY INFORMATION:
On May 30, 1975, the Nuclear Regulatory Commission (NRC) published in the FEDERAL REGISTER (40 FR 23478) a notice of proposed amendments to 10 CFR Part 20 that would extend to all NRC specific licensees the requirements of 9 20.407 for the sub-mission of an annual statistical summary report of estimated whole body radiation doses.
Section 20.408 would be amended only to 2
Enclosure "A"
I specify the same four categories of licensees presently required to i
submit reports of individual exposure to radiation and radioactive material upon termination of employment or work assignment in their f acilities.
Those categories are currently set out in 9 20.407(a) and incorporated in 6 20.408 by reference.
4 By letter dated June 2, 1975, copies of the notice of proposed rule making were sent to all specific licensees.
A majority of the 36 comments submitted in response to the notice of proposed rule making favored the amendments, but offered some suggestions for change.
Many of the commenters who opposed the proposed amendments were medical licensees who expressed ooposition to the filing of any additional reports.
They noted that additional paper work increases cost of health care delivery, and hence is ir.flationary.
Opinions were expressed that the proposal might have theoretical value, but j
]
would not be practical, that insufficient need has been shown for another administrative requirement with low benefit / cost ratio, that occupational exposures (in medical diagnosis and therapy) are "as low as practicable", that the existing requirement (S 20.403) for reporting overexposures is quite adequate to make ifcensees aware of 4
their responsibilities in cases of overexposure and only licensees with repeated overexposures should be asked to submit annual statis-i tical summary reports, that it is not possible to separate exposures received while working with NRC-licensed material from exposures received while working with X-ray, radium, or cther radiation sources 3
Enclosure "A"
not subject to NRC regulations, and that there are inherent inaccura-cies in personnel monitoring data. One commenter suggested that NRC send each licensee (1) a summary of the data collected, and (2) a reminder of the reporting requirement and a form suitable for record-ing the data. One commenter indicated a need for a longei time period in which to prepare the report.
Some commenters misunderstood the proposed amendment to S 20.408, believing that it would extend to all licensees the requirement far reports of individual exposures upon termination of employment with a licensee or work assignment in the licensee's facility.
In view of the comments that raised questions regarding the value and impc-t of the proposed amendments, the Commission staff requested, by letter dated August 25, 1976, the voluntary, one-time submission of the personnel monitoring data for 1975 by all NRC specific licensees. The letter also invited the licensees to provide an estimate of the cost of the'ir effort (1) in man-hours, and (2) in total cost of preparing the report.
The distributions of the 172 responses that estimated man-hours and of the 125 responses that estimated total cost indicated a median commitment of 2.75 minutes or $0.65 per monitored individual.
The personnel monitoring and cost data have been published as NUREG-0419.
The Commission is convinced, based on nine years of experience with reports filed by four categories of licensees pursuant to 4
Enclosure "A"
I 5 20.407 and based on the results of the one-time submission of data for 1975 by other categories of licensees, that it is necessary to the Commission's functions to receive the annual statistical summary The data are essential to the evaluation of the risk of reports.
radiation exposure as'sociated with activities conducted in licensed f
facilities.
The data will permit evaluation of exposure trends.
They also permit some assessment of the degree of radiation protec-tion efficiency that is being maintained, one indicator of the effectiveness of the Commission's regulatory program.
Tha Commis-sion recognizes the diversity of programs conducted by licensees, but believes that there is sufficient basis for comparison of expo-sure experience among types of licensees and among licensees within each type.
The NRC believes that licensees need to develop this information for their own evaluation and action in control and direction of their radiation safety programs.
Consideration of the data led to the development of Regulatory Guides 8.8, "Information Relevant to Ensuring that Occupatonal Radiation Exposures at Nuclear 4
Power Stations Will Be As Low As Is Reasonably Achievable," and 8.10, " Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable," and will assist in the identification of situations to be studied further in order that regulations and regulatory guides can be developed on action that should be taken in the design and operation of licensed facilities to assure that in plant exposures are kept as low as is reasonably achievable.
The data were used in the consideration of occupational 5
Enclosure "A"
i exposure aspects of controlling radioactive effluent releases from nuclear power plants in Appendix I, 10 CFR Part 50, and have been used to develop a variety of value/ impact analyses.
They may be used as one indicator in the assignment of priorities for inspection and enforcement actions.
The data are being used to establish pri-orities with respect to the need for regulatory attention through considaratica of the collactiva dosa in addition to individus! and average doses.
In some cases, more regulatory attention may be required for licensees with larger collective doses than for lican-sees with larger individual doses.
I 3
It should be noted, however, that the personnel monitoring data
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do not permit evaluation of what occupational exposures are "as low as is reascnably achievable." Such evaluation requires study of the specific factors associated with a specific facility and activity.
ing The Commission has considered alternative methods of obtaining t in information on the number and exposure experience of individuals iation working in licensed facilities and found them to be unsatisfactory
- o the by reason of cost or data content.
The burden on respondent licen-sees under the reporting requirement of 9 20.407 will not be large ip rts and will, of course, be directly proportional to the number of individuals monitored by a licensee.
The Commission considers the burden well justified, and has adopted the amendments in the form set forth below.
(b))
6 Enclosure "A"
l l
to control the possession and use of licensed material in such a manner that the total occupational dose received by individuals from both licensed and unlicensed sources in the licensee's possession does not exceed the standards in 10 CFR Part 20.
Thus, licensees should monitor the individual's total occupational dose ($ 20.202),
record the estimated dose in the individual's record (s 20.401), and use that total dose estimate in preparing the annual statistical summary report required by 6 20.407, as amended, and the termination report required oy 5 20.408, if applicable.
Note that @@ 20.407 and 20.408 have been amended to change the recipient of the reports from the Director of Inspection and Enforcecent to the Director of Manage-ment and Program Analysis, NRC.
The Commission has reminded each of the licensees who have been subject to the reporting requirement of the need to report each year, including a copy of the table of estimated whole body exposure ranges that may be used in filing the report.
The Commission proposes to continue this practice.
Licensees will be reminded that if personnel monitoring was not required to be provided to any individual
($ 20.202(a) or S 34.33(a)) during the calendar year, licensees are required to submit a simple statement to that effect, only.
The Commission cannot determine from the issuance of a license whether personnel monitoring is or is not required, because radioactive material licensed for possession and use may not be procured, and 8
Enclosure "A"
licensed operations may be suspended such that monitoring is not required.
The simple negative report is included to reduce the number of cases in which follow-up action might be necessary in the absence of a report being filed by a licensee.
The burden of a responding licen-see in filing the negative report is very small.
The data on person-nel monitoring are summarized each year in a report to the Commission and are available to the public.
Discussions with several commercial dosimetry services indicate that there is very little need for more than three months in which to file the annual statistical summary report.
It was indicated that scretimes delay may occur because of the late submission of dosimeters for processing, and that in some cases the exposure records are not summarized and the report prepared until after the first monitoring period in the new calendar year in an effort to include i'idividuals whose dosimeters were not submitted on time for evaluation at the end of the year.
Experience indicates that a very small number of " lost badges" and other causes of incomplete data will persist regardless of the date established for filing of the report, but tnat there should not be additional cost to licensees to process their data during the first calendar quarter of each year.
Further, it does not appear that the annual statistical summary 9
Enclosura "A"
i i
report would be significantly improved by delaying the date for filing of the report.
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and sections 552 and 553 of title 5 of the United States Code, the following amendments to Title 10, Chapter I, Code of Federal Regulations, Part 20, are published as a document subject to codification.
1.
Section 20.407 is revised to read as follows:
6 20.407 Personnel monitoring reoorts.
Each person specifically licensed by the Com=ission shall, within the first quarter of each calendar year, submit to the Director of Management and Program Analysis, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, the following reports covering the preceding calendar year:I (a) A report of either (1) the total number of individuals for whom personnel monitoring was required under SS 20.202(a) or 34.33(a) of this chapter during the calendar year; or (2) the total number of individuals for whom personnel monitoring was provided during the IA licensee whose license expires or terminates prior to, or on the last day of the calendar year, shall submit reports at the expira-tion or termination of the license, covering that part of the year during which the license was in effect.
10 Enclosure "A"
Provided, however, That such total includes at least calendar year:
the number of individuals required to be reported under paragraph (a)(1) of this section.
The report shall indicate whether it is sub-mitted in accordance with paragraph (a)(1) or (a)(2) of this section.
If personnel monitoring was not required to be provided to any indi-vidual by the licensee under $$ 20.202(a) or 34.33(a) of this chapter during the calendar year, the licensee shall submit a negative report indicating that such personnel monitoring was not required.
(b) A statistical summary report of the personnel monitoring information recorded by the licensee for individuals for whom per-sonnel monitoring was either required or provided, as described in paragraph (a) of this section, indicating the number of individuals whose total whole body exposure recorded during the previous calendar year was in each of the following estimated exposure ranges:
NUMBER OF INDIVIDUALS ESTIMATED WHOLE 80DY IN EACH RANGE EXPOSURE RANGE (rems)2 No measurable exposure Measurable exposure less than 0.1 0.1 - 0.25 0.25 - 0.5 0.5 - 0.75 0.75 - 1
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1-2
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2-3
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3-4
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4-5
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5-6
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6-7 2 Individual values exactly equal to the values separating Exposure Ranges shall be reported in the higher range.
11 Enclosure "A"
I i
ESTIMATED WHOLE BODY NUMBER OF INDIVIOUALS EXPOSURE RANGE IN EACH RANGE (rems)2 7-8 8-9 9 - 10 10 - 11 11 - 12 12+
The low exposure range data are required in order to obtain better information about the exposures actually recorded.
This section 1
does not require improved measurements.
2.
Section 20.408 is revised to read as follows:
s 20.408 Reoorts of oersonnel monitoring on termination of emoloyment or work.
(a) This section applies to each person licensed by the Com-mission to:
(1) Operate a nuclear reactor designed to produce electrical or heat energy pursuant to S 50.21(b) or S 50.22 of this chapter or a testing facility as defined in 5 50.2(r) of this chapter; (2) Possess or use byproduct material for puiposes of radiog-raphy pursuant to Parts 30 and 34 of this chapter; 12 Enclosure "A" l
i
(3) Possess or use at any one time, for purposes'of fuel pro-cessing, fabrication, or reprocessing, special nuclear material in a quantity exceeding 5,000 grams of contained uranium-235, uranium-233,-
or plutonium or any combination thereof pursuant to Part 70 of this chapter; or (4) Possess or use at any one time, for processing or manu-facturing for distribution pursuant to Part 30, 32, or 33 of this chapter, oyproduct material in quantities exceeding any one of the following quantities:
3 Radionuclide Quantity in curies Cesium - 137 1
Cabalt - 60 1
Cold - 198 100 Iodine - 131 1
Iridium - 192 10 Krypton - 85 1,000 Promethium - 147 10 Technetium - 99m 1,000 (b) When an individual terminates employment with a licensee described in paragraph (a) of this section, or an individual assigned to work in such a licensee's f acility but not employed by the licensee, 3The Commission may require, as a license condition, or by rule, j
regulation or order pursuant to 6 20.502, reports from licensees 4
who are licensed to use radionuclides not on this list, in quanti-ties sufficient to cause comparable radiation levels.
13 Enclosure "A"
l completes the work assignment in the licensee's facility, the lican-see shall furnish to the Director of Management and Program Analysis, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, a report of the individual's exposure to radiation and radioactive material, incurred during the period of employment or work assignEent in the licensee's facility, containing information recorded by the licensee pursuant to 13 20.401(a) and 20.108.
Such report shall be furnishad within 30 days after the exposure of the individual has been de'ter-mined by the licensee or 90 days after the date of termination of employment or work assignment, whichever is earlier.
Effective date.
These amendments become effective on (Sec. 161, Pub. Law 83-703, 68 Stat. 948 (42 U.S.C. 2201); Sec. 201, Pub. Law 93-438, 88 Stat. 1242 (42 U.S.C. 5841))
Dated at this day of 197.
For The Nuclear Regulatory Commission.
Secretary of the Commission 4
mA date will be inserted designating 75 days after the date of publication in the Federal Register.
14 Enclosure "A" 1
T -
(.
'j Enclosure B Draft Letter to Congressional Comittees m
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i ENCLOSURE "B" ORAFT LETTER TO CONGRESSIONAL COMMITTEES is Enclosed for the information of the a notice of rule making to amend 10 CFR Part 20 of the Nuclear Regulatory Commission's regulations.
The NRC is amending its regulations to extend to all NRC soecific '
licensees the requirement for submission of an annual statistical summary report on radiation exposure of workers.
Currently these reports are required only from four categories of licensees, i.e., nuclear reactors, industrial radiographers, nuclear fuel processors and reprocessors, and certain large commerical suppliers of byproduct mater,ials.
These four categories of licensaes were considered to involve the greatest potential for significant occupational exposures.
Notice of proposed amendment to the regulations on this matter was published in the Federal Register on May 30, 1975, providing a period of 45 days for public comment.
Following evaluation of the comments, in an effort to obtain sample data for evaluation and to determine the cost of this reporting to the licensees, licensees were requested to submit as a voluntary, one-time action, the personnel monitoring data for 1975.
The data and cost estimates are being published as NUREG-0419.
After consideration of the comments on the proposed rule, nine years of experience with reports from the four categories of licensees presently covered, the voluntarily submitted data for 1975, and other factors Enclosure "B"'
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1 involved, the Commission has adopted the amendments in the form set forth in the enclosed notice of rule making.
The notice is being filed with the Office of the Federal Register.
The amendments will become effective 75 days after publication in tne Federal Register.
Also enclosed is a cop'y of a draft public announcement to be released by the Commission on this matter in the next few days.
I Enclosure "B"
B Enclosure C Draft Public Announcement G
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i ENCLOSURE "C" ORAFT PUBLIC ANNOUNCEMENT NCR Amends Regulations to Require Statistical Summary Reports on Worker Radiation Exposures From All NRC Licensees The Nuclear Regulatory Commission is amending its regulations to extand t: all t:RC licensees the requiramant for annual statistical su: mary reports on worker radiation exposures.
Currently, these summaries are required only from certain types of licensees.
Under present NRC regulations, four categories of licensees are required to submit an annual statistical summary of monitored whole body exposures -- that is, the number of people in each of 18 prescribed ranges of radiation exposure. The data are being used to better evaluate the occupational exposures being experienced by employees of those licensees.
The four categories are those which were considered to involve the great-est potential for significant occupational exposures.
The amendment to Part 20 extends this statistical summary reporting requirement to all NRC specific ifcensees.
The amendments do not involve any changes in the requirements for the provision and use of personnel monitoring equipment or the records of personnel monitoring data that must be kept.
The changes relate solely to reporting data already recorded.
The proposed amendments to Part 20 were published on May 30, 1975, for public comment.
Later, in an effort to determine the cost of the Enclosure "C"
i report to licensees and to obtain data for one year for evaluation, NRC requested the voluntary submission of reports for 1975.
The personnel monitoring and cost data collected for the 1975 period have been published in a report entitled " Occupational Radiation Exposure at NRC-Licensed Facilities 1975," NUREG-0419.
The report will be available for' purchase through the National Technical Information Service, Springfield, Virginia 22161 for $4.50.
The amendments to Part 20 beirg published in the FEDERAL REGISTER on 4
will be effective l
1 Enclosure "C"
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Enclosure O Abstracts of Coments and Staff Response e
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i ENCLOSURE "D"
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ABSTRACTS OF COMMENTS AND STAFF RESPONSE Lester A. Slaback, Defense Nuclear Agency, Armed Forces Radiobiological 1.
Research Institute.
"I feel that this proposal will not achieve its stated purpose...the ALAP evaluation requires knowledge of specific factors peculiar to each specific facility and activity.
This proposal does not attempt to acquire such knowledge.
It is not considered likely that such knowledge can be acquired on 'a blanket questionnaire basis nor is it judged likely that it could be extracted from information in licensing files...the tabulation for operations at our facility would include exposures from at least four diverse types of operations.
Consequently, I feel that it is unlikely that a non-specific blanket requirement such as this could succeed even if an attempt was made to modify it to include additional information as to the circumstances of exposure.
Not even addressed here are the inaccu-racies of personnel radiation dosimetry, differences even among groups using the same kind.', dosim?try, the question of administrative assignment of deses due to lost or damaged dosimeters, varying reliability of personnel participation in the dosimetry progrs=, etc. etc....
The statistical uncertainties in the sampling assumptions...would seem to negate any possible value in the information collected...it is suggested that in depth studies of selected specific operations in as controlled a fashion as possible would be an approach more likely to meet the stated objective.
If an unstated objective was to form a data base for compliance operations this proposal would still seem inappropriate for reasons already stated.
A specific review of the pertinent records by an inspector would appear to be much more effective..."
STAFF RESPONSE. The notice of proposed rule making clearly stated that the data do not permit evaluation of what occupational exposures are as low as practicable, but that the data are being used to identify situations to be studied further in order that guidance can be developed on action that should be taken to keep occupational radiation exposures ALARA.
Other licensees have programs that involve comparably diverse activities,
) Enclosure "D"
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and valid comparisons are possible.
The staff is well aware of the limita-tions of personnel monitoring devices, and the other dosimetry problems cited by the commenter. While efforts are being made to improve the accuracy of dosimetry, the staff believes that personnel monitoring measurements sufficiently characterize the radiation environment in which individuals work to provide an adequate basis for radiation protection evaluation purposes, and desires to be informed as to the estimated expo-sures actually being recorded.
Use of the data to establish compliance with regulatory exposure limits was not an objective of the staff.
2.
Arthur J. Solari, The University of Michigan "The revised Section 20.407...will create some problems of compliance for us.
The problem arises from the time limitation specified as the first quarter of each calendar year.
To comply with the proposed r.egula-tion, we would have to take the yearly summary of whole body exposure from the Form 5s supplied by the film badge company.
There is no other complete and convenient source for the required information.
Unfortunately, as a ru'le, we do not get these forms until the second quarter of the following I fear that pressure on the film badge companies to prepare year. :..
these reports sooner would result in substantially increased costs and/or a greater frequency of errors."
STAFF RESPONSE.
Conversations with two of the large commercial dosimetry services (Landauer, Searle) do not support the commenter's concern. They indicated that it is common practice to' wait until the end of the first monitoring period of the new year in order to pick up " stragglers," and that there are a number of these, " lost badges," and other causes of incomplete data, in spite of the delay. They indicated that preparation of the Form NRC-5, " Current Occupational External Radiation Exposure," as a service to customers is not a lengthy task because the whole process is
) Enclosure "0"
computerized. Commercial dosimetry services offer to prepare the summary reports free or for a very small fee, regardless of the number of indi-viduals monitored by the customer.
3.
Dr. Russel C. Briggs Dr. John F. Gibbons, Maine Medical Center
...we would request that the proposed amendment in 20.408, paragraph 8, be altered to delete the obrase 'or an individual assigned to work in such a licensee's facility but not employed by the licensee'..."
STAFF RESPONSE.
The commenters failed to understand that the proposed amendment to 5 20.408 did not change the text o'f the existing regulation except to specify the four categories of licensees to which the requirement applies.
The four categories are currently included in 9 20.408 by refer-
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ence to 5 20.407(a).
Further, the commenters are medical licensees, not subject to the reporting recuirement of 5 20.408.
4.
Dr. John C. Bates, Memorial Hospital of Sandusky County, Fremont, Ohio "I read in "Kiplinger Washington Letter" that President Ford was calling all department heads to inform them it was not necessary to create The problems with government rules and regulations especially paperwork.
above [ notice of proposed rulemaking] might have theoretical value, but is not practical."
STAFF RESPCNSE. The statistical summary report has been in effect for four categories of licensees, and has already been found to be practical and of value to the staff.
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i 5.
Dr. Charles 0. Pruett, Bluefield Sanitarium Clinic, Bluefield, West Virginia
"...I would like to state that I am categorically opposed to such amendrgents.
In small operations such as ours, such proposals are ridicu-lous and is just another example of monstrous governmental meddling in areas where there should be no meddling.
If I am stupid enough to expose myself to dangerous doses of radiation, it is my business and no one else's business.
Regulations already in existence make it almost impos-sible for Nuclear Laboratories to operate anywhere except in large teaching institutions."
STAFF RESPONSE.
The commenter greatly exaggerates the burden on respondents under the reporting requirement.
The staff disagrees with the philosophy expressed by Dr. Pruett.
In addition to the question of NRC responsibility to protect an individual against himself, exposure of staff of the clinic may also be in question.
6.
Dr. O. John Wright, Geisinger Medical Center, Danville, Pennsylvania
...While compliance with Paragraph 20.407 of 10 CFR 20 would be relatively simple for those of your licensees concerned with the applica-tion of radiation in the healing arts, i.e., in the hospital environment, there appears to be some difficulty in separating out monitnring records of exposure due to licensed operations from those due to operations that do not come under the licensing of the NRC.
In many instances, staff will be concerned with the use of radioactive materials that are not by products, and the same staff may also be concerned with the use of X-rays, exposure from gamma-rays from Cobalt 60 used in teletherapy, exposure from gamma-rays in sealed sources from radium and cesium, and exposure from the range of radionuclides used in our Nuclear Medicine Division....
This confusion may very well serve to render questionable the comparative evaluation of occupational radiation and exposure risks that this proposed rule is study.
I would suggest that some system of reporting should be arranged so that at least the reports indicated whether the number of individuals in each range included individuals who were also exposed to radiation from sources that did not come under NRC license."
STAFF RESPONSE. The staff is aware of the point made by Dr. Wright.
However, other licensees have programs that involve comparably diverse activities, and valid comparisons are possible.
Dr. Wright was reminded Enclosure "0"'
by letter dated July 24, 1975, that pursuant to f 20.l(b), licensees are required to control the possession, use, and transfer of licensed material
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in such a manner that exposure to such material and to radiation from such material, when added to exposures to unlicensed radioactive material and to other unlicensed sources of rad'iation in the possession of the licensee, does not exceed the radiation protection standards in 10 CFR Part 20.
Thus, the total occuoational radiation exposure of individuals who may be exposed in the course of their work with unlicensed sources as well as licensed sources, should be monitored, recorded in the individual's files, and if the proposed amendments are made effective, included in the annual statistical summary report.
Exposure received by an individual as a patient under medical diagnosis or the,rapy would not be included.
7.
Wilbur J. Dunphy, State of Maine, Department of Transpcrtation
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"This is te notify that the State of Maine is.in receipt of your recent mailing....
If any comments concerning this proposal are made, they will be forwarded to the Secretary..."
STAFF RESPONSE.
None.
This is not a " comment" on the proposed amendments 8.
Dr. I. B. Syed, Wesson Memorial Hospital, Springfield, Massachusetts "I strcngly oppose the amendments...particularly Section 20.407...for the following reasons:
1.
It is unfair for the proposed amendment to extend to all NRC specific licensees...NRC specific licensees who are using by product materials for medical diagnosis and therapy should be exempt in view of the fact that occupational exposures are 'as low as practicabl e. '
NRC inspectors and compliance enforcement officers must be aware of this fact.
They can check the personnel monitoring reports whenever they inspect the licensee.
2.
Section 20.403 Notification of
[ Incidents] is quite adequate to make the licensees aware of their responsi-bilities in cases of overexposures to individuals...
Only licensees filing incidents of overexposure repeatedly should be asked to submit annual statistical summary reports which requirement should be phased out
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in five (5) years if the licensee shows a good record...
3.
Specific licensees under human use of byproduct materials should be exempt because it involves more paper work, time, and personnel, and increases the cost of health ca're and delivery--and hence it is inflationary."
STAFF RESPONSE.
It is no more " unfair" for one type of licensee to be required to report than another.
There may be many circumstances,where occupational exposures in medical-licensee facilities are ALARA.
- However, Dr. Syed's categorical statement to that effect is premature and unfounded.
The staff does not consider it adequate or appropriate to limit concern to While any reporting requirement involves more paper work, overexposures.
time, and personnel, it has been estimated that 2.75 minutes of clerical time per monitored individual would be necessary to prepare the report.
Further, the reports may be prepared by commercial dosimetry services for a very modest' fee (see staff response to comment 2).
This small respondent burden is well justified.
9.
Dr. Paul H. Brown, Veterans Administration Hospital, Providence, R.I.
...I am in favor of the annual reporting of statistical data... I would like to suggest the following:
1.
The Commission should send each licensee a summary of the data it has collected from these reports.
The summary should be mailed before the end of the second calendar quarter.
2.
The Commission should send each licensee a reminder of the reporting requirements and a form suitable for recording the data in the format desired.
These items should be mailed during January."
STAFF RESPONSE.
Copies of the annual summary reports are being made available to the public as NUREG documents, and are available upon request.
It is not proposed to send copies to all licensees.
Each of the approxi-mately 450 licensees subject to the present reporting requirement, has been reminded each year of the need to report.
The staff would propose to
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continue this practice, including provision of a copy of the table of estimated whole body exposure ranges that may be used in filing the report.
10.
Rodger W. Granlund, The Pennsylvania State University, University Park, PA.
"... Paragraph (a) [6 20.407] requires a report based on either the number of individuals for whom personnel monitoring was required or the number for whom personnel monitoring was provided.
This seems superfluous in light of paragraph (b) which requires a summary of the number of indi-viduals with various estimated whole body doses.
Thus, paragraph (b) lists all individuals who were monitored and the number with doses greater than a certain value shows the number for whom monitoring was required, other than minors or persons entering high radiation areas.
The explana-tion of the proposed change does not provide justification for adopting the new requirements, nor is any report given on the usefulness of the data previously obtained...
My objection is not to supplying the informa-tion but to the addition of another administrative requirement with a very low benefit / cost ratio."
STAFF RESPONSE.
The option provides for licensees to report whichever is easier under their circumstances, the number of individuals required to be monitored, or the number who were provided monitoring for any other reason.
The licensee is not given the option to decide, after the fact, whether or not monitoring was required. We regret that the commenter does not consider the reasons given in the notice of proposed rulemaking to constitute justification for adoption.
11.
Dr. A. J. Tidaback, Blanchard Valley Hospital, Findlay, Ohio
...a question of interpretation has arisen in our minds.
Are those teletherapy device for radiation therapy 80 individuals who operate a Cobalt purposes obliged to submit personnel monitoring reports under 10 CFR 20.407 and also under 10 CFR 20.408? Since we do not use Cobaltso for radiography but only for radiotherapy, it would not appear to us that we are subject to 20.408.
Are we then subject to submit personnel monitoring reports as outlined in 10 CFR Part 20.407?..." Enclosure "0"
STAFF RESPONSE.
This is not a comment on the proposed amendments.
Dr. Tidaback was informed by letter of July 9,1975, that the requireme,nt of S 20.408 for termination reports does not currently apply to medical licensees.
The reference in 6 20.407(a)(2) to persons licensed to " Possess or use byproduct material for purposes of radiography pursuant to Parts 30 and 34 of this chapter," is to persons conducting industrial radiography.
Section 20.408 veuld be amended only to include specification of the same four categories of licensees, currently incorporated into S 20.408 by reference to s 20.407(a).
Dr. Tidaback was also informed that, if the proposed amendment to 6 20.407 is adopted, all NRC specific licensees would be required to submit the annual statistical summary report.
12.
James C. Carlson, Hackley Hospital, Muskegon, Michigan "I object to your proposed changes...
As indicated, you desire this change to improve your knowledge of the amounts of radiation being received by radiation workers.
It is common practice in scientific investigations to use sampling techniques to obtain statistically valid results at the minimum cost.
I suggest that these principles should be applied here, also, in order to bring the cost of the information gathering, analysis, enforcement and storage in line with the value of the information. We in the health care industry are continually reminded by governmental agencies of the need to minimize health care costs and to provide benefits commen-surate with the costs. The proposed directive will add to health care costs without providing a corresponding benefit...."
STAFF RESPONSE. The Commission has several years of experience with data obtained from four categories of licensees considered to represent the greatest potential for exposures, and has found the data to be very valu-able.
The staff now wishes to obtain comparable data from all licensees.
The respondent burden is small, see Staff Response to comments 2 and 8.
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13.
Dr. George W. Callendine, Consulting Radiologic Physicist, Worthington, Ohio
"...I can understand the need for broadbased statistical evaluation of -
exposure data and feel that the Nuclear Regulatory Commission is in a unique position to accumulate this data. One possible complicating factor would be that many technicians in the medical field are involved in both radiographic and nuclear medicine procedures, in taking positioning films and so forth, and the total exposure data would not be strictly nuclear exposure data... it seems to me sufficient to provide...the monitoring information giving the actual exposure values for each individual who is being monitored and permitting them [NRC] to collate this information as they see fit.
The requirement that each person must regrouo the data to fit the expousre range categories...is a great convenience for the Regula-tory Commission personnel but is one other job requiring time and expenses Since this expense must be passed on to the patients it of the licensee.
seems to me to be somewhat unfair to expect the patient to underwrite the i
statistical summary which the Regulatory Commission is instituting.
I, therefore, suggest that the Regulatory Commission accept a copy of the exposure data for monitored personnel.
STAFF RESPONSE.
Individual monitoring data would, of course, be of equal or greater value to the staff than the statistical summary reports proposed The individual data have not been requested in view of '
for submission.
previous objections that included greater cost to the licensee as well as implied use of the data for epidemiological or workmen's compensation Again, staff estimates of the respondent burden indicate purposes.
it to be small.
14.
James C. W'ynd, State of Ohio, Department of Health "The proposed revision of Section 20.407...is confusing.
On the one hand,...each person specifically licensed by the Commission shall submit a report of '---the total number of individuals for whom personnel monitoring was provided-- ' (as distinguished from the total number for whom personnel monitoring was required under 20.202(a) or 34.33(a)) and two sentences later states the 'If personnel monitoring was not required to be provided---
under 20.202(a) or 34.33(a)---the licensee shall submit a negative report indicating that such personnel monitoring was not required...
The para-graph (b) requires ' A statistical summary report---for individuals for.
It is not whom personnel monitoring was-either required or provided---! Enclosure "D"
1 at all clear to me whether the intent of the Commission is to make manda-tory the reporting of information on personnel monitoring not required under 20.202(a) or 34.33(a) or whether, by the use of intentionally vague and confusing language, the licensee is to be inveigled into submitting reports which he believes to be mandatory but which, in reality, are not.
If, in fact, the intent is to make mandatory the reporting of information on personnel monitoring not required under 20.202(a) and 34.33(a), the proposed revised Section 20.407 should not be made confusing by inclusion of the sentence requiri g the licensee, in such circumstances, to submit
'---a neoative report indicating that such personnel monitoring was not required'.
STAFF RESPONSE. The option of reporting the data on individuals for whom personnel monitoring was either required or provided was made available in an attempt to relieve licensees from making a determination whether moni-toring was required or not, if the licensees chose to provide the monitor-ing for other reasons.
The simple negative report was included to reduce the number of cases in which follow-up action might be necessary in the event that no report is submitted by licensees.
15.
Stan A. Huber, Hospital Consultant - Nuclear Medicine Specialist, New Lenox, Illinois "I have one suggeston for an addition to the proposed... amendment...
that there be specific ending date to the investigation after sufficient data has been accumulated. With a nationwide influx of data, I would think that 2 years of annual summary reports should be sufficient.
The 2
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year period I propose is consistent with the FDA requirements for hospitals to maintain case history reports on investigational drugs, which is also for safety and statistical analysis purposes. Without an ending date to the gathering of statistical information, the proposed amendment to Section 20.407 would go far beyond its stated purpose (statistical analysis) and would require much more expense of both the government and the licensees than would be warranted for the expressed philosophy of evaluation what' occupational exposures are 'as low as practicable'."
STAFF RESPONSE. Much of the benefit from the personnel monitoring data 4
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stems from the provided capability to evaluate trends and to compare on going experience among types of licensees and among licensees within
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each type.
However, the evaluation of successive annual data may indicate declining benefit and could lead the staff to recommend modification or termination of the reporting requirement.
16.
Larry M. Luckett, Nuclear Medical Science Officer, U.S. Army, Aberdeen, Maryland
...the following comments are submitted.
1.
...To report the total number of cersons monitored would not be representative of the occupational exposure due to licensed materials.
Trying to separate those occupation-ally exposed to licensed material from all those who were monitored would place an increased strain on overworked personnel, especially for those large activities where there are not facilities for automatic data pro-cessing of the personnel monitoring records.
2.
In some instances, primarily in medical facilities, personnel are occupationally exposed to multiple sources of ionizing radiation in addition to licensed materials.
While it is impossible to separate the individual's exposure due to licensed mat 2 rial from the total personal exposure from all sources, to report the total exposure to the NRC would not be representative of occu-pational exposure to licensed materials.
To report personnel exposures to non-licensed sources would not be advantageous or meaningful in comparison to other licensees....
The information most readily obtained will not be usaful in a meaningful camparison to other licensaes.
However, in ordar to obtain data that would allow a meaningful comparison, additional anal-ysis or guidance on interpretation is needed.
STAFF RESPONSE.
See Staff Response to comments 1 and 6.
17.
Larry Petcovic, Bel Air, Maryland
... Recommend consideration of requiring licensee to submit the following data with reports:
1.
Type of personnel monitoring device (TLD, film,etc.)
2.
Accuracy of data (% error, etc.)
3.
Yearly minimum sensitivity at stated accuracy.
Reason:
Since the Commission is per-forming a statistical analysis concerning as low as practical experience, analyzing monitoring systems and their interrelationship would be of fundamental value.
The reliability of low dose data is of concern and this opportunity of collective data analysis is rare.
With the intent of providing a meaningful comparison of current exposure experience among types of licensees, an area of further consideration is as follows:
1.
Inspectors that are exposed to a variety of ionizing radiation sources and multiple licensees.
A licensee possesses several BML, SNM and other sources not controlled by NRC.
The personnel monitoring devices are not controlled or recorded by license number or type. All exposure data is Enclosure "0"
4 cumulative and not differentiated by license.'
2.
Individual radiation workers, who in the process of performing duties, are handling and are being exposed by radioactive sources from more than one licensee.
. STAFF RESPONSE.
The staff is well aware of the limitations of personnel monitoring devices. While efforts are being made to improve the accuracy and precision of dosimetry devices, the staff believes that personnel monitoring measurements sufficiently characterize the radiation environment in whicn individuals work, and does not prcpose to increase the burden on respondents by requiring the additional information suggested by the co== enter.
See Staff Response to comments 1 and 6.
18.
Norman L. Sylvester, Ranco Controls Division, Columbus, Ohio
"...Section 20.407(a) as amended requires that if personnel monitoring was not required to be provided to any individual during the calendar year, tha licensee shall submit a negative report...
It seems fair to assume that somewhere in a computer memory information must exist which would indicate which licensees are not required to nave personnei monitoring.
If this is the case, the informaton could be retrieved and summarized to provide the statistical input required.
This approach, if possible, would obviate the necessity for licensees to report that they do not do something they are not required to do.
The considerable cost to licensees of writing letters would be eliminated.
Further, the cost of having government employees read the letters and enter the data would also be eliminated."
STAFF RESPONSE.
The issuance of a license does not assure that personnel monitoring is or is not required.
Material authorized for possession and use may not be procured, and operations may be suspended such that moni-toring is not required. The simple negative report was included to reduce the number of cases in which follow-up action might be necessary in the event that no report is submitted by licensees.
The burden to the responding licensee in filing a negative report is minimal, as is the entry of the datum into the computer. Enclosure "D"
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t 19.
David L. Bernd, Medical Center Hospitals, Norfolk, Virginia
...we acknowledge the value of ascertaining what occupational exposures are 'as low as practicable,' and realize that such an evaluation would require a study of the specific factors associated with a specific facility and activity. We fail t.o see, however, why the annual submission of the number of persons monitored or for whom monitoring was required, along with a statistical summary report of the personnel monitoring infor-mation recorded for such individuals, should be a condition of a medical institute's license, and therefore mandatory.
Although personal records are kept of recorded exposures, statistical summaries are not routinely compiled, and the need for such a compilation would only mean additional expense for the institution.
This may not be very significant where computer capabilities are available; however, it could be quite significant for a small medical center where no such facilities are at hand. We would suggest that such information could be gathered on a voluntary basis as has been done in patient X ray exposure studies and similar epidemiological investigations, and recommend that the proposed amendment not be incorpo-rated into the regulations, thereby avoiding another unnecessary imposition on medical licensees."
STAFF RESPONSE.
No amendments to specific licenses is proposed, but rather amendment to the regulations.
The burden on respondents would be proportional to the number of individuals monitored, and is considered small.
See Staff Response to comments 2 and 8.
20.
Wm. K. Johnson, State of Missouri, Oisaster Planning and Operations Office, Civil Defense, Jefferson City, Missouri
...The Adjutant General of Missouri, has studied the proposed change as referenced above and has no further suggestions or comments regarding the same."
STAFF RESPONSE.
None.
21.
R. V. Scheele, St. Vincent Hospital, Green Bay, Wisconsin "While I can understand the rationale of evaluating personnel exposure data for groups of occupationally exposed individuals, I believe, in many cases, the proposed reporting scheme would not provide the Commission with meaningful data...due to the fact that it is difficult, if not impossible, Enclosure "0"
g to separate exposures due to licensed activities from non-licensed activi-ties...
I would recommend that licensees which do not work solely with licensed material be exempt from it."
STAFF RESPONSE.
See Staff Response to comments 1 and 6.
22.
Blaine N. Howard, State of Utah, Department of Social Serv' ices "We... accept the prerogative of the Commission to gather the informa-tion for the study proposed but question the revision of the regulations to require the continuing submission of the information.
We would hooe that the comparative study could come to an early conclusion and that a permanent change in the reporting procedure need not be made."
STAFF RESPONSE.
See Staff Response to comment 15.
23.
Dr. Eugene L. Saenger, University of Cincinnati, College of Medicine
"...These reporting requirements have been under continual attack by many persons since they were originally proposed by AEC in March 1966.
The objections are several:
1.
No apparent use has been made of the data already collected.
2.
It is useless to record in a Federal Repository how much radiation is being used unless there are specific :schanisms to follow radiation workers health records systematically to relate dose to effect.
3.
As yet, neither the AEC, ERDA, or NRC has developed efficient methods for long-term follow-up of workers known to have radiation injuries or to have received doses of sufficient magnitude to make the long-term likelihood of such injury probable.
Excellent examples of such failures include difficulties in follow-up of licensee injuries about which I have corresponded with AEC since 1966, and the difficulties in follow-up of plutonium and radon workers with known relatively high radiation doses.
4.
Since the models which are being used for radiation protection either are "as low as practicable" or the interpolative one used in the BEIR Report, the linear no threshold hypothesis, it would seem far more desir-able to assemble data on effects rather than dose alone.
For these reasons, I would strongly urge reconsideration and abandonment of massive Federal Record Keeping until some useful application of these data could be realized.
Enclosed is a draft manuscript of mine prepared in 1967 which comments on these points in greater detail."
STAFF RESPONSE. Dr. Saenger s reference to proposals in 1966, the draft i
manuscript, and the reference to " massive Federal Record Keeping" imply Enclosure "D"
7 that he is not aware of the amendment to 6 20.407 published January 4, 1974, that shifted from reporting of individual exposure data and incorpo-
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ration in the repository, to submission of the annual statistical summary report.
Inat cnange eliminated most of the opposition to earlier proposals.
Further, Dr. Saenger appears to be calling for the epidemiological studies that so much of the earlier comment opposed, primarily because of recog-nized difficulties in translating personnel monitoring data to " dose" received by individuals.
Dr. Saenger may not be aware of the use of the data already being received in the development of guidance on maintaining occupational exposure as low as is reasonably achievable.
24.
Donald S. Murray, University of Pennsylvania
...We agree that information about exposure experience of licensees not currently reporting such information could be informative to the Commission.
iiowever, we believe that information meeting the stated needs of the Co=issica may be secured without requiring by regulation annual reports as proposed. We strongly question the need for annua' sampling...
we strongly believe that suitable comparative exposure information could be obtained without the continuing burden of a regulatory requirement for annual reporting by any of several ways.
1.
Coordinate securing of exposure summaries with compliance inspections.
2.
Sampling surveys of licensees, perhaps by questionnaire...
3.
By contracting a study as in (2) or entering nominal contracts with licensees to provide desired summary reports for stated periods of coverage...
Regardless of the means of deriving comparative exposure information, there are a number of deficien-cies in the reporting scheme as inherent in 10 CFR 20.407.
1.
By accepting all monitoring information, rather than only that required for NRC con-trolled exposure, the information pertinent to the NRC will often be severely distorted.
Many individuals are monitored through convenience or to confirm lack of exposure rather than because their work involves signif-icant potential... there is a very real likelihood that reports would distort occupational exposure experience with the low exposure results of persons monitored for reasons other than actual exposure potential.
Secondly, in many institutions such as medical schools, research insti-tutions and hospitals there are a nominal number of persons deriving modest radiation exposure from NRC controlled sources and a substantially higher number deriving exposure solely from x-ray equipment and other sources not subject to NRC regulation.
Accepting this information would strongly distort the actual exposure experience associated with radiation l
- Enclosure "D" l
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I 4
sources under NRC control.
2.
The exposure ranges set forth in 20.407b are excessively differentiated particularly in the low exposure categories...there are far to many non-exposure related factors that would determine the distribution of entries in the several lower exposure ranges categories for such differentiation to be of any value.
Requiring such differentiation, however, implies a statistical validity to the entries despite the disclaimer...
Some are:
frequency of changing monitoring devices, types of monitoring device, which monitoring service is used, i
reporting practice of different monitoring services, and recording prac-tices of the licensee.
Further, where badges are kept during off-duty hours may make substantial differences at the low exposure ranges..."
STAFF RESPONSE.
The Commission staff has considered alternative methods l
of obtaining information on the number and exposure experience of individ-uals involved in licensed activities and found them unsatisfactory by reason of cost or data content. We estimate the burden on respondents to be small, see Staff Response to comments 2 and 8.
Other licensees have programs that involve comparably diverse activities, and valid comparisons i
are possible, see Staff Response to comments 1 and 6.
Staff recognition of the nuaber of factors that influence entries in the lower exposure ranges led to the footnote to the list of exposure ranges in 6 20.407.
4 Without the lower ranges, attempts to approximate total man-rems of exposure received in various types of activity would be erroneously high.
(One method of making such an estimate is to multiply the number of indi-viduals in an exposure range by the midpoint of the range.
If the lower exposure ranges were eliminated, large numbers of individuals with low exposures would be multiplied by exposure values much higher than they received.)
25.
George F. Murphy, Ledgemont Laboratory, Kennecott Copper Corporation
...we believe that the intended requirement of reporting by all licensees will impose an unnecessary burden on licensees and will not, we Enclosure "0"
believe, significantly improve the information available to the NRC.
Our suggestion is that a selected group of licensees, representing a cross section of all users, be monitored to evaluate the effectiveness of the regulations at the present time. We, as a small user, have never exceeded
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the allowable concentrations for our workers and in fact we never had an exposure greater than 20 millirems in any one exposure period.
The imple-mentation of such a requirement might be cause to remove individuals now being monitored by film badge from this service in order to avoid time consuming and needless additional monitoring reports..."
STAFF RESPONSE. We have estimated th'e respondent burden to be very small, see Staff Response to comments 2 and 8.
The staff recognizes th t many licensees choose to monitor individuals that would not be required to be monitored by 9 20.202.
The wording of $ 20.407 provides that, if personnel monitoring was not required to be provided, the licensee shall submit a simple negative report indicating that fact. We do not believe that the small burden of the reporting requirement will be determinate in whether or not to continue to provide monitoring to persons beyond regulatory requirements.
The potential value of negative exposure data in the event of claim filed against the licensee is significant.
Fuither, other costs of providing and maintair.ing a monitoring program far exceed the burden of the reporting requirement.
26.
Ronald E. Zelac, Temple University "As proposed, the amended Part 20 may not accomplish its stated aim
'to permit comparable evaluation of the occupational radiation exposure risks associated with all categories of licensed activities'. This results from the fact that supplied data...would probably not be comparable from one institution to another or from this class of licensees to others.
In some or perhaps in most instances, those individuals who are involved with machine produced radiation only (no licensed material) will be included in the statistical summary, not being differentiated from others in the overall radiation protection program of the facility. This will, from our experience skew the data toward higher exposures.
Not including machine-only individuals in the summarj would add appreciably to the time, effort, and/or cost involved in the preparation....
In most cases, I would expect Enclosure "D"
that the summary will be prepared from computer files by the commercial company providing personal monitoring service to the institution..."
STAFF RESPONSE.
Other licensees have programs that involve comparably diverse activities, and the staff is convinced that comparisons are possi-ble and potentially valuable.
D uglas K. Garfield, Beckman Intruments, Inc., Fullerton, California 27.
... Articles 20.407 and 20.408 should provide for exemptions for cases where an agency other than the NRC controls the personnel monitoring, reporting, and record requirements of the licensee.
For example, Beckman possesses an NRC Byproduct Material License #04-02624-03E for the distri-bution of " Exempt Quantity" byproduct material, pursuant to 10 CFR 32.18.
All other controls over the use of radioactive material, including personnel monitoring, are governed by Radioactive Material Licenses...and the Radia-tion Control Regulations as published in Title 17, California Administra-tive Code...It appears as though the proposed amendments...a duplication of jurisdictional control...We propose that an exemption be granted in 10 CFR 20.407 and 20.408, or in 10 CFR 32.18 to eliminate this jurisdictional duplication."
STAFF RESPONSE.
If personnel monitoring is required for operations con-ducted by a licensee, the staff desires to be informed of the -nature of the exposures being received.
It is highly unlikely that monitoring would be required for the activities mentioned, and a simple negative report is sufficient.
None of the Agreement States have, to date, adopted compa-If the States rable reporting requirements for personnel monitoring data.
do adopt such requirements, provision could be made for the filing of duplicate reports by persons who are licensees of both a State and the NRC.
> Enclosure "D"
f 4
28.
Dr. Richard J. Vetter, Purdue University "It has been my observation, and compliance inspector's reports should confirm this, that many licensees, especially educational institu-tions, are very liberal in handing out personnel monitors.
The philosophy of many health physicists is to badge all personnel who work with radiation producing devices or nuclides which emit neutrons, gammas or energetic betas, regardless of the potential radiation exposure...
Subsequently, personnel monitoring reports have long lists of personnel with no measur-able exposure reported.
It is my opinion that the greatest impact of the proposed amendment to 20.407 would be to discourage this good health physics practice and encourage the use of personnel monitoring equipment only when required by law.
In addition, the cost in time and money of assembling an annual statistical report would place a heavy burden on l
already tight university budgets and would further encourage the use of personnel dosimetry only when required.
Finally, I question the usefulness of statistical reports from universities.
First, nearly all radiation workers at a university have annual exposures in the lowest two or three
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Second, a significant fraction of those who have higher exposures ranges.
work partly or wholly with non-NRC controlled-radiation.
Third, because of the large variety of radiation useage at a university the statistical report would be meaningless when trying to coordinate specific data to a specific activity..."
STAFF RESPONSE. We io not believe that the small burden of the reporting requirement will be determinata in whether or not to continue to provide monitoring to persons beyond regulatory requirements.
See Staff Response to comment 25.
Again, the staff is convinced that comparisons are possible and potentially valuable among licensees within types, such as universities.
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29.
W. J. Shelly, Kerr-McGee Nuclear Corporation "The main impact of this new regulation will be the accumulation of quantities of individual records of exposure in the files of the NRC as individuals are terminated from the Nuclear Energy Program...the accumula-tion of a file of radiation data from one source such as the Nuclear Industry on individuals does not present complete epidemiological data for evaluation of the impact of that industry.
Such data should also include all types of exposure including ~ diagnostic or therapeutic uses of radiation.
The accumulation of an individual's exposure data would only be useful to him or his physician in evaluating future health conditions or to an epidemiologist for evaluating an industry impact...
Current reporting requirements of 10 CFR 20.407 require the summary report for occupational exterr.a1 radiation for regulatory purposes..." Enclosure "0" l
4
STAFF RESPONSE.
The commenter failed to understand that the amendment to S 20.408 regarding submission of reports of individual exposure on termi-nation of employment or work assignment in a licensee's facility, did not involve extension to all licensees, but merely specified the four cate-gories of licensees currently required to report.
Those four categories were previously included in 5 20.408 by reference to S 20.407(a).
30.
Anthony Ma::occhi, Oil, Chemical and Atomic Workers International Union "The... Union endorses and supports the NRC proposed rulemaking... We have reviewed these reports for those licensees that are currently required to submit them and have found these reports to be invaluable in judging the progress or lack of progress in reducing radiation exposure.
Such a reporting system permits comparisons to be made among like groups of licensees... We do recommend two additions to this rulemaking.
First, we request that these regulations go into effect immediately so that the 1975 data will become available early in 1976.
Second, we recuest that a provi-sion be acceo to these regulations requiring the licensee to post tne summary report and also to serve a copy of the report on the authorized
-employee representative.
It is essential that the employee representative has this information so that it may properly fulfill its obligations under the law in protecting the health of its members."
STAFF RESPONSE.
Section 19.13, 10 CFR Part 19, requires licensees to make certain reports of exposure available to workers.
It is not proposed to require licensees to post or provide copies of the statistical summary report to employee representatives. The statistical summary reports will be a matter of public record, and copies of the annual report to the Commission summarizing the data will be made available to the public as NUREG documents.
I Enclosure "0" 1
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31.
Sheldon Meyers, U.S. Environmental Protection Agency
...We agree with the rationale stated in the proposed amendments to extend the requirements to all categories of such licensees.
In our opinion, however, this rationale can also be applied to the case of NRC Agreement States' licensees.
It is our understanding that these states presently do not have equivalent annual reporting requirements.
Because the Agreement Stata licensees undoubtedly comprise a significant and growing traction of the national total, we believe it highly desirable that in the present or future rulemaking (or by means of separate arrange-ments between NRC and its Agreement States), provision be made to institute equivalent state reporting requirements.
Under such an arrangement, an Agreement State's licensees would annually report to that State; and that State, in turn, would annually submit to NRC a statistical summary report for each NRC-designated category of licensee.
In this manner, NRC would have a complete set of data for making more valid comparisons among licensees or a given category, among categories, and among Agreement States.In addition and related to the above, there does not appear to be any reascn for NRC to continue to impose " termination of employment" reporting requirements solely on the present four categories of specific licensees.
To be consistent in the proposed rulemaking, NRC should also make this provision apply to all categories of its specific licensees..."
STAFF RESPONSE. The staff does not propose to make the imposition or reporting requirements a matter of compatibilit with Agreement States.
The EPA..is conducting a project involving three phases of contract work regarding statistical data on annual occupational exposures to ionizing radiation within the United States.
The first phase was the development of alternative means, the second ipvolves testing the feasibility of the selected alternative, and the third would be routine operation.
The program would serve as an information feedback system to the continuing surveillance functions of EPA's Occupational Exposures Program and in the reviewing, updating, and revising of existing basic guidance.
The EPA is obtaining its data on licensed activities from NRC,'and that greatly influences their comment on the NRC proposed rule.
The termination reports l
of S 20.408 were primarily justified to evaluate the number and exposure Enclosure "0"
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t
t experience of transient workers.
As such, the staff does not propose to extend that reporting requirement beyond the four categories of licensees that are believed to experience significant use of such transient labor.
32.
8111 F. Pearson, HEW, Public Health Service, Indian Health Service, Aberdeen, South Dakota "Since Indian Health Service personnel who are occupationally exposed to radiation, either from Medical / Dental X-ray operation or in the use of radionuclides, are monitored continuously and periodic reports submitted to Indian Health Service Headquarters, we believe the proposed requirement for a separate report is redundant. We suggest that the proposed revision of Section 20.407 " Personnel Monitoring Raports", be amended to eliminate reports from individual licensees where a parent organization has the necessary statistical data in consolidated form, i.e., Teledyne Corporation X-Ray File Badge Printout. We further suggest that the proposed revision of Section 20.408,...be similarly amended to reflect the acceptance of consolidated reports from Parent Organizations."
STAFF RESPONSE.
NRC has regulatory authority only over its licensees, and any reporting requirement must necessarily be addressed to such licensees.
In the case of the Indian Health Service, if the " Parent Organization" is able and willing to forward, in behalf of its member groups, the data being requested, it would be quite acceptable.
In lieu of such an arrange-ment, a member group could file with the NRC a copy of the report submitted to the Parent Organization. The commenter would not'be required to report under existing 6 20.408, and may not understand that the proposed amendment of that section was solely to incorporate the specification of the four categories of licensees that would continue to be required to submit the i
l termination reports.
, Enclosure "0" l
s
i 33.
Frank J. Dux, Airco Industrial Gases, Riverton, New Jersey
...We feel that many organizations utilizing radioactive materials have neglected the policy of ' low as practicable' occupational radiation exposures and have substituted a policy of merely keeping exposures below the limits expressed in 20.101.
The proposed amendment, if adopted, will serve to emphasize the importance of constantly working to reduce the exposure of employees to radiation.
The amendment can only be regarded as beneficial to employees."
STAFF RESPONSE.
None.
34.
Dr. Mary S. Strang, Chief of Nuclear Medicine, St. Vincent Health
- Center, Erie, Pennsylvania
...It must sound very nice to you down there in Washington to have all these delightful people like us out in the woods sending you reports once a year.
Again, unindating all of us with more paper and to add to our woes of personnel.
It seems to come just about the time that Congress doesn't want private people to cut down the National Forests.
And yet, there is an idea of where is all the paper coming from.
You may have gathered I am extremely against such proposal as in the words of our Radiation Physicist, they are ' Mickey Mousing it down there again'.
No one seems to realize that as the regulations gradually increase, so do the corps out in the field.
It is truly getting comoletely out of hand.
I am beginning to think that everybody down in Washington has completely lost their reasons, and wandering around in the land of Alice.
Please sit tight on this amendment for awhile, and sleep on it, wake up at three a.m. and cogitate on it, take a walk regarding it, and just pretend that you had to send in a report on how many times you did not take out the garbage that week. Would if your wife had to send in a report on how many times she burned her finger on a certain make pot?...
I always thought the Atomic Energy Commission was really a delightful elite group, I always felt that they represented a small source of sanity within the paperwork of our federal government system.
It seems that you are begin-ning to be dragged down by your confreres.
Bounce it off a few of your grandparents or your great-uncles who have survived many years in this country.
Don't add to our woes out here in the country. We are trying to do a good job...
May I reiterate that I am against another regulation that will only add to our work.
- Besides, the regulation wishes to have it reported right around Income Tax time-you have got to be kidding!
May I hope that you will just use plain ordinary common sense as there is also already a mechanism built into your regulations years ago of reporting abnormal values.
I wish I could think of something really clever to implore you to please have some empathy for we wee people out here in the woods...."
l I
1 I Enclosure "0" I
STAFF RESPONSE.
The commenter has, in colorful language, exaggerated the burden on respondents of the proposed reporting requirement.
See Staff Response to comments 2 and 8.
35.
Dr. C. L. Meints, Simpson College, Indianola, Iowa "The proposed amendment...does not discriminate between regular or heavy users of isotopes and that large class of occasional users who may not have any use at all in a particular year or may have a few separate uses anotner year. The point is not tnat sucn users are or snould be exempt from recording personnel exposures, but that the proposed yearly report will be overlooked unintentionally, thus placing the user in viola-tion of CFR each year...Your statistical interest does not really extend to the infrequent, low quanity user anyway...Perhaps low quantity users should be exempt..."
STAFF RESPONSE.
Licensees will be reminded of the reporting requirement each year and sent a copy of the table of estimated whole body exposure ranges that may be used in filing the report.
If personnel monitoring was not required to be provided during a year, a simple statement to that effect is all that is required.
36.
Dr. G. U. Biedlingmaier Dr. Rocco Latorraca, Trinity Memorial Hospital, Cudahy, Wisconsin
...I respectfully suggest that any additional paper work imposed upon my section of the hospital would be counter productive. We have maintained adequate records and have concerned ourselves with the exposure of our personnel, having been aware of the hazards of radiation for many years and have taken appropriate safety measures.
At the current rate of required forms to be submitted, not only for your Regulatory body but to many others, it will be necessary for us to employ additional personnel to keep up with the requirements..." Enclosure "0"
4 s
STAFF RESPONSE.
See Staff Response to comments 2 and 8.
14 Hospital, Physicians, Medical Consultants 7
Educational Institutions 6
Federal Agencies, State Officials 5
Industry 2
Military 1
Labor Union 1
Individual 36 f
J Enclosure "D"
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