[Federal Register Volume 60, Number 28 (Friday, February 10, 1995)]
[Rules and Regulations]
[Pages 7900-7903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3372]



=======================================================================
-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations concerning the frequency at which medical fitness 
determinations 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 amended rule requires 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. The final rule reduces the burden on licensees without 
adversely impacting public health and safety.

EFFECTIVE DATE: March 13, 1995.

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 M. 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.
    A proposed rule was published in the Federal Register on September 
16, 1994 (59 FR 47565), for public comment. Ten letters of comment were 
received, all supporting the proposed rule. Consequently the NRC is 
codifying the rule as it was proposed.
    The final rule provides for periodic medical examinations at either 
the 12-month interval as currently required or optionally at a 
frequency determined by a physician. Under this rule, licensees can 
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 will 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 final rule uses the terminology ``medically fit'' rather than 
``physically able'' to use a respirator. As indicated in 
[[Page 7901]] the proposed rule, this terminology has been substituted 
because it more accurately reflects the purpose of the medical 
examination. None of the public commenters objected to this change.
    ANSI Z88.6-1984 also 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.''
    It should be noted that the NRC staff position is that a complete 
physical examination of each respirator user is not required, only an 
initial medical examination and annual or periodic review of medical 
status and that physicians need not administer each test personally, 
but may designate individuals such as office nurses as long as the 
physician is responsible for the program. It is also important to note 
that Occupational Safety and Health Administration (OSHA), State and 
other requirements regarding use of respirators and fitness evaluation 
for exposure to other toxic materials are not waived by this 
rulemaking.
Agreement States
    The amendment applies to all NRC licensees. Agreement States must 
establish and maintain compatible regulations and programs. Most 
radiation protection provisions in 10 CFR part 20 are classified as 
Division I matters of compatibility. However, 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 rule is 
therefore a Division II matter of compatibility. This 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. Although Agreement States had the opportunity to 
comment on this proposed change during the public comment period, none 
submitted comments.
Description
    The provisions of 10 CFR 20.1703 (a)(3)(v) are 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,'' 
and the term ``medically fit'' is substituted for the current term 
``physically able,'' to make clearer the purpose of the medical 
determination.
Impact
    The Commission believes that this change constitutes 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 will 
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 years; \1/3\ >35 but 
<45; \1/6\ >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 will 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 rule is expected to result in a reduction in costs 
due to a reduced frequency of medical reexamination for these 
licensees.
    Although some costs will be incurred by licensees in making 
revisions to procedures and license conditions, these costs will be 
offset by the increased flexibility and savings resulting from reduced 
reexamination frequency.
    Ten letters of public comment were received on the proposed rule: 
The Nuclear Energy Institute (NEI) and seven nuclear utilities 
including Tennessee Valley Authority (TVA), the University of Texas 
System, and the National Institute for Occupational Safety and Health 
(NIOSH) of the Department of Health and Human Services (HHS).
    NEI, the seven nuclear utilities, and the University of Texas 
System all supported the proposed rule. These commenters agreed that 
the proposed changes would constitute a reduction of regulatory burden 
and an increase in flexibility for licensees and Agreement States, 
without any significant reduction in worker health and safety. Several 
agreed that the recommended age-related frequencies for reexamination 
found in ANSI Z88.6-1984 should not be codified and should continue to 
provide useful guidance to physicians and other professionals in 
determining the suitability of individuals for respirator use. The 
proposed rule was characterized as appropriately performance-based and 
as not restricting the exercise of professional medical judgment.
    Several commenters agreed that the initial determination by a 
physician should occur prior to initial fitting of respirators, rather 
than prior to first field use. These commenters observed that although 
this change would provide further reduction in burden, there is no 
clear evidence that such a change would not adversely impact the 
current level of protection of public health and safety. Others agreed 
that considerable liability would result if a worker were to experience 
an adverse reaction to a respirator during an initial fit-test without 
having had the requisite medical determination.
    NIOSH supported the NRC goal of reducing the time and effort in the 
medical fitness determination process. They suggested however, that the 
NRC should use the word ``evaluation'' rather than ``examination'' when 
discussing the determination of medical fitness. NIOSH said that the 
content of an evaluation could include, medical history, questionnaire, 
physical examination, laboratory tests (such as dextrocardiogram, 
spirometry, or exercise testing) and results of a monitored worker 
trial period.
    NIOSH recommended that a medical fitness evaluation be performed 
initially, and annually thereafter or after any significant illness, 
injury or surgery [[Page 7902]] that might affect a worker's fitness to 
use respirators. However, the content of the reevaluations would be 
determined by a physician and would not necessarily include a physical 
examination. For example, a questionnaire could be used by a physician 
to determine whether or not more extensive reevaluations were 
necessary.
    NOISH also recommended that the initial evaluation include at least 
a limited physical examination that could be performed by a physician 
or by a non-physician health professional.
    The NRC staff believes that its intent is in substantial agreement 
with NIOSH. Several NRC staff documents have discussed the medical 
fitness determination in a manner consistent with the NIOSH suggestion. 
The NRC position continues to be that a complete physical examination 
of each respirator user is not required, only an initial medical 
examination and an annual review of medical status (or less frequently 
as determined by a physician).
    The physician might or might not require a physical examination as 
part of the health assessment. The NRC staff believes that physicians 
need not administer each test personally, but that the physician may 
designate someone such as an office nurse to certify medical fitness as 
long as it is clear that the physician is ultimately responsible for 
the fitness determination. Likewise, the NRC staff believes that the 
physician should be involved in the supervision of the fitness program, 
the review of overall results and individual cases that fall outside 
certain physician determined parameters, and supervision of personal 
performing the tests.
    The final rule retains the language ``* * * 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.'' The rule, as codified by this 
action, does not use the terms examination or evaluation. The NRC does 
not believe that the level of detail suggested by NIOSH is necessary in 
the regulations because all of the activities fall within the framework 
of the ``determination'' by a physician and would be considered as 
acceptable practice. The discussion in this statement of consideration 
makes it clear that the fitness determination can consist of several 
instruments and methods, as suggested by NIOSH.
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 will 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 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 is to allow a reduction in the frequency of such 
examinations, thus reducing any conceivable environmental impact even 
further. No comments on the draft assessment in the proposed rule 
notice were received.
Paperwork Reduction Act Statement
    This final 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 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 a peer 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 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 change 
is to permit reducing the frequency at which the examinations are 
required based on determination by a physician. This action constitutes 
a reduction in burden and costs. Although minor changes in procedures 
or license conditions will be needed, the related costs are a one time 
cost that will be offset by the savings in medical reexamination costs.
Workers
    Workers will 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, will be adequate to identify any medical reasons for 
not using respirators. The action does not impact medical examination 
requirements adopted by licensees for other reasons. Licensees will 
continue to be required to conduct medical examinations.
NRC Resources
    It is estimated that 0.4 staff years of effort by NRC staff will 
have been expended to complete this rulemaking.
Regulatory Flexibility Certification
    In accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), 
the NRC [[Page 7903]] certifies that this rule will not have a 
significant economic impact upon a substantial number of small 
entities. The amendments apply to all NRC and Agreement State 
licensees. Because these amendments reduce burden, they are considered 
to have no adverse economic impact on any large or small entities.
Backfit Analysis
    Because 10 CFR part 20 applies to all NRC licensees, any 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 rule 
will 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 change does not 
constitute a backfit. In addition, the effect of these 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 will 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 will be 
necessary if a more flexible frequency of examination is adopted. 
However, the costs will be offset by the savings in reduced frequency 
of examination. Thus, the NRC believes that the modifications are not 
backfits. No comments were received on this issue during the public 
comment period for the proposed rule.

List of Subjects 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. 552 and 553; the NRC is adopting 
the following amendments to 10 CFR part 20.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

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

    Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, (42 U.S.C. 
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 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 1st day of February 1995.

    For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 95-3372 Filed 2-9-95; 8:45 am]
BILLING CODE 7590-01-P