Frequency of Medical Examinations for Use of Respiratory Protection Equipment

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 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]

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