# Frequency of Medical Examinations for Use of Respiratory Protection Equipment > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A94-22983 ## Record - **Collection:** Federal Register - **Document type:** Uncategorized Document - **Published:** September 16, 1994 ## Text NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 RIN 3150-AF08 Frequency of Medical Examinations for Use of Respiratory Protection Equipment AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Nuclear Regulatory Commission (NRC) proposes to amend its regulations concerning the frequency at which medical examinations are required to ensure the safe use of respiratory protection equipment. Section 10 CFR 20.1703 (a)(3)(v) currently requires the determination by a physician prior to initial fitting of respirators, and at least every 12 months thereafter, that the individual user is physically able to use the respiratory protection equipment. The proposed revision would require determination by a physician prior to initial fitting of respirators and either every 12 months thereafter or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment. DATES: Comment period expires November 15, 1994. Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date. ADDRESSES: Mail written comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Deliver comments to: 11555 Rockville Pike, Rockville, Maryland between 7:45 am and 4:15 pm Federal workdays. Copies of public comments received may be examined at: the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6223. SUPPLEMENTARY INFORMATION: Background The requirement for an annual medical examination to ensure safe use of respiratory equipment has been in the regulations for some time. The need for these examinations was reconfirmed by the American National Standards Institute (ANSI) in ANSI Z88.2-1992. However, considerable experience with implementation of the requirement has indicated that the annual frequency of medical examinations is costly and could be reduced significantly with no adverse impact on health and safety. The NRC Regulatory Review Group reviewed the existing requirement and concluded that the frequency of medical examinations could be reduced without adverse impact on worker safety. This change was recommended to the Commission as a candidate for licensee burden reduction in SECY-94-003 and supported by the Commission by memorandum from Samuel J. Chilk to James R. Taylor dated February 14, 1994. The ANSI reviewed this issue and, in ANSI Z88.6 1984, published a recommendation that the frequency of medical examination should be determined by a physician and should be reduced based on age of the worker. ANSI recommended an examination every 5 years up to age 35, every 2 years up to age 45, and annually thereafter. ANSI also recommended special additional evaluations after prolonged absence from work for medical reasons or whenever a functional disability has been identified. These ANSI recommendations were reconfirmed in ANSI Z88.2- 1992. Consideration was given to changing the time of medical examination to before first field use instead of before initial fitting of respirators, to provide additional relief of regulatory burden. Consideration was also given to codifying the ANSI frequencies as the minimum acceptable frequencies for reexamination. Comment is specifically requested on these considerations. The proposed rule would provide for periodic medical examinations at either the 12-month interval as currently required or optionally at a frequency determined by a physician. Under this proposed rule, licensees could elect to have the physician include in the initial medical examination or at the next 12-month reexamination, a determination of when each individual would need to be reexamined. Part 20 requires written procedures for use of respiratory protection equipment. Consequently, current procedures and license conditions likely include the annual frequency and a change in procedures or license conditions would be needed to implement a change in frequency of reexamination. The recommended frequencies contained in the ANSI standard may provide guidance on determining an appropriate frequency of reexamination which may be useful to physicians in determining frequency of reexamination. However, the Commission is not endorsing this standard. Rather the Commission believes that the frequency of reexamination should be determined by the examining physician. The proposed rule uses the terminology ``medically fit'' rather than ``physically able'' to use a respirator. This terminology has been substituted because it more accurately reflects the purpose of the medical examination. ANSI Z88.6-1984 provides guidelines for the scope of an examination which would demonstrate that a worker was medically fit to use respiratory protection devices. The guidelines include consideration of pulmonary function, cardiovascular factors, neurological and psychological conditions, among others. The NRC staff believes that these guidelines provide an acceptable working definition of the term ``medically fit.'' Agreement States The proposed amendment would apply to all NRC licensees. Agreement States must establish and maintain compatible regulations and programs. Although the radiation protection provisions in 10 CFR Part 20 are normally Division I matters of compatibility, this rulemaking defines minimum procedures needed to ensure health and safety. As such, an Agreement State should have the flexibility to keep the 12-month frequency or to impose an alternate frequency of examinations if considerations in their State warrant such an approach. The proposed rulemaking is therefore a Division II matter of compatibility. The proposed change was not provided to the Agreement States in advance of this notice because the change has nominal impact on materials licensees and because the change is a relaxation of the current regulatory requirement. However, this proposed rulemaking was discussed with representatives of Agreement States at the Organization of Agreement State Managers Workshop and Public Meeting on Rulemaking in Herndon, VA, on July 12, 1994. No comments or objections were offered by the States. Agreement States have the opportunity to comment on this proposed change during the public comment period. Description The provisions of 10 CFR Part 20.1703 (a)(3)(v) would be changed to require determination by a physician prior to initial fitting of respirators, and periodically thereafter, either every 12 months or at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment. Frequency of reexamination is changed from ``at least every 12 months,'' to ``either every 12 months thereafter or periodically at a frequency determined by a physician,'' with guidance from ANSI on recommended frequencies provided in this statement of considerations. Guidance on the scope of the medical examinations is provided in ANSI Z88.6-1984. Impact The Commission believes that these proposed changes will constitute a reduction of regulatory burden and an increase in flexibility for licensees, without any significant reduction in worker health or safety. The medical profession contributed significantly to development of the reduced frequencies recommended by ANSI and it is therefore expected that physicians performing examinations will be guided by the ANSI recommendations. ANSI recommended a frequency of reexamination based on age: every 5 years up to age 35; every 2 years up to age 45; and annually thereafter. A change in procedures or license conditions would likely be needed to implement a change in frequency of reexamination. The respiratory use medical examination is estimated to cost approximately $150 per examination. The number of examinations performed during an outage at a nuclear power plant is estimated to be 500. If 60 plants have outages each year, the current cost for annual medical examinations is at least $4,500,000. An examination of the demographics of the nuclear workforce (\1/2\ 35 but 45) suggests that the number of medical examinations could easily be halved thus saving $2.25 million each year just during maintenance or refueling outages at nuclear power plants. Clearly, considerable savings can be realized by this change freeing resources for more effective health and safety efforts. Certain materials licensees such as fuel cycle facilities, some research facilities including broad scope academic licensees and some manufacturing groups also have respiratory protection programs. The impacts on these licensees are minimal because the number of respirator users is small. The proposed rule is expected to result in a reduction in costs due to a reduced frequency of medical reexamination. Although some costs would be incurred by licensees in making revisions to procedures and license conditions, these costs would be offset by the increased flexibility and savings resulting from reduced reexamination frequency. Income to the medical profession would be reduced somewhat in those areas where significant respiratory programs are in place. Finding of No Significant Environmental Impact: Availability The NRC has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and therefore, an environmental impact statement is not required. The NRC has not prepared a separate draft environmental assessment. The following discussion in conjunction with the regulatory analysis which follows constitutes the assessment. Performing a medical examination to determine that a worker is medically fit to use respiratory protection equipment generates minimal waste, results in small recordkeeping burden, and has no other identifiable environmental impact. The effect of this rulemaking would be to allow a reduction in the frequency of such examinations, thus reducing any conceivable environmental impact even further. Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, approval number 3150-0014. Regulatory Analysis The regulatory analysis for this proposed rulemaking is as follows: 1. Alternatives No Action The annual medical examination requirement has been in place for a number of years, and is considered by the NRC staff to provide adequate health and safety to workers. However, the annual requirement consumes considerable resources with little demonstrated improvement in worker health or safety when compared to longer examination intervals. The ANSI committee and an extensive public review of the proposed standard Z88.6 (1984) found no reasons for not reducing the frequency of medical examination. Thus, it would appear that the frequency of medical examination can be significantly reduced at considerable savings and with no adverse impact on worker health and safety. The ``no-action'' alternative is not preferable in view of the cost of compliance relative to the minimal risk reduction observed. Regulatory Guidance The alternative of modifying the guidance in Regulatory Guide 8.15 is not considered a viable alternative for providing regulatory relief because the existing rule is very specific, and requirements in the regulations cannot be revised by modifying a regulatory guide. Changes to Regulation Because the problem is a specific requirement in a rule, the most effective solution providing regulatory relief is to modify the rule. Other alternatives such as issuance of an order, modifying license conditions or discretionary enforcement were considered. These alternatives are usually interim and are used when immediate action is deemed necessary. Because a permanent correction is desired and since there is no reason for immediate action, these other alternatives were not selected. 2. Impact of Proposed Action Licensees Licensees that have respiratory protection programs will continue to be required to provide medical examinations to workers. The only proposed change is to permit reducing the frequency at which the examinations are required based on determination by a physician. This action would constitute a reduction in burden and costs. Although minor changes in procedures or license conditions may be needed, the related costs are a one time cost that would be offset by the savings in medical reexamination costs. Workers Workers would be subject to medical examinations for respirator use less frequently. As found by the ANSI review, experience with the annual respiratory medical examination requirement has shown that less frequent examinations for younger workers, with special examinations if conditions change, would be adequate to identify any medical reasons for not using respirators. The proposed action would not impact medical examination requirements adopted by licensees for other reasons. Licensees would continue to be required to conduct medical examinations. Thus, the health and safety of workers would not be impacted. NRC Resources It is estimated that 0.2 staff years of effort by NRC staff would be expended during the next year to complete this rulemaking. The NRC requests public comment on this regulatory analysis. Comments on the analysis may be submitted to the NRC as indicated under the ADDRESSES heading. Regulatory Flexibility Certification Based upon the information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic impact upon a substantial number of small entities. The proposed amendments would apply to all NRC and Agreement State licensees. Because these amendments would reduce burden, they are considered to have no adverse economic impact on any large or small entities. However, the NRC is seeking comments and suggested modifications because of the widely differing conditions under which small licensees operate. Any small entity subject to this proposed regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the NRC of this in a comment that specifically discusses the following items-- (a) The licensee's size in terms of annual income or revenue, number of employees; (b) How the proposed regulation would result in a significant economic burden upon the licensee as compared to that on a larger licensee; (c) How the proposed regulation could be modified to take into account the licensee's differing needs or capabilities; (d) The benefits that would be gained or the detriments that would be avoided by the licensee if the proposed regulation was modified as suggested by the commenter; and (e) How the regulation, as modified, would still adequately protect the public health and safety. Backfit Analysis Because 10 CFR Part 20 applies to all NRC licensees, any proposed changes to this part must be evaluated to determine if these changes constitute backfitting for reactor licensees such that the provisions of 10 CFR 50.109 apply. The following discussion addresses that evaluation. The 10 CFR 50.109 definition of ``Backfit'' includes any modification of the procedures required to operate a facility resulting from an amended provision in the Commission's rules. Because this proposed rule would permit but not require nuclear power reactor licensees to modify their procedures regarding the frequency of respiratory medical examinations, the NRC staff believes that the proposed change does not constitute a backfit. In addition, the effect of these proposed changes is to increase flexibility and reduce the frequency at which medical examinations for respiratory use are required. It is estimated that this rule change would save the nuclear power industry and other NRC and state licensees several million dollars per year with no adverse impact on worker health and safety. Some minor changes in procedures or license conditions could be necessary if a more flexible frequency of examination is adopted. However, the costs would be offset by the savings in reduced frequency of examination. Thus, the NRC believes that the modifications proposed are not backfits. List of Subjects in 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Source material, Special nuclear material, Waste treatment and disposal. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to adopt the following amendments to 10 CFR Part 20. PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION 1. The authority citation for Part 20 continues to read as follows: Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2282); sec. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846). 2. In Sec. 20.1703, the introductory text of paragraphs (a) and (a)(3) is restated and paragraph (a)(3)(v) is revised to read as follows: Sec. 20.1703 Use of individual respiratory protection equipment. (a) If the licensee uses respiratory protection equipment to limit intakes pursuant to Sec. 20.1702-- * * * * * (3) The licensee shall implement and maintain a respiratory protection program that includes-- * * * * * (v) Determination by a physician prior to the initial fitting of respirators, and either every 12 months thereafter or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment. * * * * * Dated at Rockville, Maryland, this 6th day of September, 1994. For the Nuclear Regulatory Commission. James M. Taylor, Executive Director for Operations. [FR Doc. 94-22983 Filed 9-15-94; 8:45 am] BILLING CODE 7590-01-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-22983. Public record. Not legal advice.