[Federal Register Volume 59, Number 179 (Friday, September 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22983]


[[Page Unknown]]

[Federal Register: September 16, 1994]


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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.

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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 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 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