7900 Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Rules and Regulations

for collection of civil penalties and

assessments imposed under this part

and specify the procedures for such

actions.

§ 185.144 Right to administrative offset.

The amount of any penalty or

assessment which has become final, or

for which a judgment has been entered

under § 185.142 or § 185.143, or any

amount agreed upon in a compromise or

settlement under § 185.146, may be

collected by administrative offset under

section 3716 of title 31, United States

Code, except that an administrative

offset may not be made under section

3716 against a refund of an overpayment

of Federal taxes, then or later owing by

the United States to the defendant.

§ 185.145 Deposit in Treasury of the

United States.

All amounts collected pursuant to this

part shall be deposited as miscellaneous

receipts in the Treasury of the United

States, except as provided in section

3806(g) of title 31, United States Code.

§ 185.146 Compromise or settlement.

(a) Parties may make offers of

compromise or settlement at any time.

(b) The reviewing official has the

exclusive authority to compromise or

settle a case under this part at any time

after the date on which the reviewing

official is permitted to issue a complaint

and before the date on which the ALJ

issues an initial decision.

(c) The authority head has exclusive

authority to compromise or settle a case

under this part at any time after the date

on which the ALJ issues an initial

decision, except during the pendency of

any review under § 185.142 or during

the pendency of any action to collect

penalties and assessments under

§ 185.143.

(d) The Attorney General has

exclusive authority to compromise or

settle a case under this part during the

pendency of any review under § 185.142

or of any action to recover penalties and

assessments under section 3806 to title

31, United States Code.

(e) The investigating official may

recommend settlement terms to the

reviewing official, the authority head, or

the Attorney General, as appropriate.

The reviewing official may recommend

settlement terms to the authority head,

or the Attorney General, as appropriate.

(f) Any compromise or settlement

must be in writing.

§ 185.147 Limitations.

(a) The notice of hearing with respect

to a claim or statement must be served

in the manner specified in § 185.108

within 6 years after the date on which

such a claim or statement is made.

(b) If the defendant fails to file a

timely answer, service of a notice under

§ 185.110(b) shall be deemed a notice of

hearing for purposes of this section.

(c) the statute of limitations may be

executed by written agreement of the

parties.

[FR Doc. 95–3347 Filed 2–9–95; 8:45 am]

BILLING CODE 6325–01–M

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
Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Rules and Regulations 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 agerelated 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
7902 Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Rules and Regulations

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 ‘‘noaction’’ 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
Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Rules and Regulations 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 § 20.1703, the introductory text

of paragraphs (a) and (a)(3) is restated

and paragraph (a)(3)(v) is revised to read

as follows:

§ 20.1703 Use of individual respiratory

protection equipment.

(a) If the licensee uses respiratory

protection equipment to limit intakes

pursuant to § 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

DEPARTMENT OF THE TREASURY

Office of the Comptroller of the

Currency

12 CFR Part 3

[Docket No. 95–02]

RIN 1557–AB14

Capital Adequacy: Deferred Tax Assets

AGENCIES: Office of the Comptroller of

the Currency, Treasury.

ACTION: Final rule.

SUMMARY: The Office of the Comptroller

of the Currency (OCC) is amending its

capital adequacy rules with respect to

deferred tax assets. This final rule limits

the amount of certain deferred tax assets

that a bank may include in Tier 1 capital

for risk-based capital and leverage

capital purposes.

The OCC, in consultation with the

Board of Governors of the Federal

Reserve System (FRB), the Federal

Deposit Insurance Corporation (FDIC),

and the Office of the Thrift Supervision

(OTS) (banking agencies), developed

this final rule in response to the

Financial Accounting Standards Board’s

(FASB) issuance of Statement of

Financial Accounting Standards No.

109, ‘‘Accounting for Income Taxes’’

(FAS 109), in February 1992. The

banking agencies adopted the provisions

of FAS 109 for reporting in quarterly

Consolidated Reports of Condition and

Income (Call Reports) beginning January

1, 1993. This reporting change increased

the amount of net deferred tax assets

that a bank may record on its balance

sheet. This final rule will ensure that

national banks do not place excessive

reliance on deferred tax assets to satisfy

the minimum capital adequacy

requirements.

EFFECTIVE DATE: April 1, 1995.

FOR FURTHER INFORMATION CONTACT:

Thomas G. Rees, Professional

Accounting Fellow, Office of the Chief

National Bank Examiner, (202) 874–

5180; Eugene W. Green, Deputy Chief

Accountant, Office of the Chief National

Bank Examiner, (202) 874–5180; Roger

Tufts, Senior Economic Advisor, Office

of the Chief National Bank Examiner,

(202) 874–5070; Ronald Shimabukuro,

Senior Attorney, Legislative and

Regulatory Activities Division, (202)

874–5090, Office of the Comptroller of

the Currency, Washington, DC 20219.

SUPPLEMENTARY INFORMATION:

Background

In February 1992, the FASB issued

FAS 109. FAS 109 provides guidance on

how to account for income taxes,

including deferred tax assets, and was

effective for fiscal years beginning on or

after December 15, 1992. FAS 109

generally allows a bank to report certain

deferred tax assets it could not

previously recognize, which has the

effect of increasing bank capital levels.

Consequently, the OCC and the other

banking agencies were concerned about

the impact of the change on the

financial institutions they regulate,

especially regarding their reported

capital levels.

FAS 109—Deferred tax assets are

assets that reflect, for financial reporting

purposes, the benefits of certain aspects

of tax laws and rules. Under FAS 109,

a bank reports deferred tax assets that

arise from: (1) Tax carryforwards, and

(2) deductible temporary differences.

Tax carryforwards are deductions or

credits that a bank cannot use for

current tax purposes, but may carry

forward to reduce taxable income or

income taxes payable in a future period