Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations 32969

Dated: June 12, 1998.

Robert C. Keeney,

Deputy Administrator, Fruit and Vegetable

Programs.

[FR Doc. 98–16091 Filed 6–16–98; 8:45 am]

BILLING CODE 3410–02–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 32

RIN 3150–AF76

License Applications for Certain Items

Containing Byproduct Material

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is amending its

regulations that govern licensing

requirements for persons who

incorporate byproduct material into

certain items or who initially transfer

certain items containing byproduct

material. This action is being taken in

response to a petition for rulemaking

submitted by mb-microtec, Inc. (PRM–

32–4), to allow the distribution of

timepieces that contain less than 25 mCi

of gaseous tritium light sources (GTLS)

to be regulated according to the same

requirements that regulate timepieces

containing tritium paint. This final rule

simplifies the licensing process for

distribution of certain timepieces

containing tritium paint and

accommodates the use of a new

technology for self-illuminated

timepieces.

EFFECTIVE DATE: August 17, 1998.

FOR FURTHER INFORMATION CONTACT:

Donald O. Nellis, Office of Nuclear

Material Safety and Safeguards, U.S.

Nuclear Regulatory Commission,

Washington DC 20555, Telephone (301)

415–6257 (e-mail address don@nrc.gov).

SUPPLEMENTARY INFORMATION:

I. Background

II. Public Comments on the Proposed Rule

III. Response to Public Comments

IV. Agreement State Compatibility

V. Environmental Impact: Categorical

Exclusion

VI. Paperwork Reduction Act Statement

VII. Regulatory Analysis

VIII. Regulatory Flexibility Certification

IX. Backfit Analysis

X. Small Business Regulatory Enforcement

Fairness Act

I. Background

A petition for rulemaking was

received from mb-microtec, Inc. (RPM–

32–4), and noticed for public comment

on October 29, 1993 (58 FR 53670). This

petition requested that those timepieces

having GTLS be placed on the same

regulatory basis as timepieces with

luminous tritium paint. No public

comments were received on the notice.

NRC regulations that are relevant to

this petition are the following:

1. Under 10 CFR 30.15(a)(1), persons

who receive, possess, use, transfer, own,

or acquire timepieces containing

byproduct material are exempted from

NRC’s licensing requirements provided

that not more than the following

quantities of byproduct material are

contained in the timepiece or hands or

dials:

(I) 25 mCi of tritium per timepiece;

(ii) 5 mCi of tritium per hand;

(iii) 15 mCi of tritium per dial (bezels,

when used, shall be considered part of

the dial).

Quantity limits for timepieces

containing promethium-147 are also

included.

2. Broad general requirements in

§ 32.14(d)(1) are applicable to the

method of containment or binding of the

byproduct material incorporated into

the products specified in 10 CFR 30.15.

Specific prototype testing requirements

for tritium-painted dials, watch hands,

and pointers are also provided in

§ 32.14(d)(1). No prototype testing

procedures are provided for timepieces

containing GTLS.

3. An exemption from licensing

requirements in § 30.19 is similar to that

found in 10 CFR 30.15(a)(1) with respect

to self-luminous products containing

tritium, krypton-85, or promethium-147;

but unlike § 30.15(a)(1), it does not limit

the quantity of these radionuclides that

may be incorporated into various parts

of the product. However, It does require

persons who manufacture, process,

produce, or initially transfer such

products to apply for a specific license

under § 32.22.

4. An extensive list of requirements in

§ 32.22 must be met in order to obtain

a specific license to distribute such

products, and § 32.23 and § 32.24

provide safety criteria that must be

demonstrated prior to issuance of a

license to distribute such products.

The petitioner stated that current

regulations were overburdensome and

counterproductive, and that watch

manufacturers do not want to become

involved with the present licensing

procedures required under § 32.22

concerning GTLS watches.

The NRC believes that the health and

safety impact from using timepieces

with GTLS would likely be positive

because the radiation dose to the public

from the use, storage, distribution, etc.,

of timepieces using GTLS is less than

the dose to the public from timepieces

containing tritium paint if the same

amount of tritium is used in both types

of timepieces. This is because the

tritium leak rate from timepieces using

GTLS is lower than from timepieces

using tritium paint because of

significantly lower tritium leak rates

from sealed glass tubes than from

timepieces containing the same amount

of tritium as paint. Thus, allowing the

exempt distribution of timepieces using

GTLS under the same regulatory

requirements as those used for

timepieces containing tritium paint

could result in a lower dose to an

individual and a lower collective dose

to the public. The distribution of

timepieces containing larger quantities

of gaseous tritium (up to 200 mCi) has

been approved for use under § 32.22,

‘‘Self-luminous products.’’ These

timepieces have been evaluated against

the safety criteria specified in §§ 32.22,

32.23, and 32.24 and have been found

acceptable.

The NRC believes that including

GTLS in § 32.14(d) to allow their

exempt distribution for use under

§ 30.15 would reduce unnecessary

burdens for both the licensees and the

NRC. Without the adoption of this

alternative, licensees have to

manufacture timepieces under the

stringent criteria in §§ 32.22, 32.23, and

32.24. The NRC must also review

product design against these

requirements. Because these stringent

requirements are not deemed necessary

for smaller quantities of tritium, these

burdens could be avoided without

affecting public health and safety. Based

upon the foregoing, the NRC has

concluded that the distribution under

§ 30.15 and § 32.14 should be allowed.

On September 19, 1997 (62 FR 49173),

the NRC published a proposed rule that

incorporated the petition in part, by

removing the existing specific testing

procedures for tritium from the

regulations and leaving only a modified

first sentence in § 32.14(d)(1):

(1) The method of containment or

binding of the byproduct material in the

product is such that the radioactive

material will be bound and will not

become detached from the product

under the most severe conditions which

are likely to be encountered in normal

use and handling.

This modification of § 32.14(d)(1)

represented a performance-based

approach by removing the existing

specific testing procedures from the

regulations and was expected to provide

increased flexibility in the regulations

and the accommodation of future

developments in the technology of

tritium illuminated timepieces, as well
32970 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations

as other products exempt from the

requirements for a license under § 30.15.

II. Public Comments on the Proposed

Rule

The comment period on the proposed

rule closed December 3, 1997. Three

comment letters pertaining to the

proposed rule were received, each

addressing a different element of the

rule. These comments are discussed in

the following section.

III. Response to Public Comments

The first commenter approved the

changes made in § 32.14(d)(1) but

requested, as a step toward international

harmonization, that the NRC adopt the

International System of Units (SI) in

prescribing the quantities of byproduct

material incorporated into products

distributed to persons exempt from

licensing as specified in § 30.15. In

addition, the commenter requested that

the quantity limit for tritium specified

in § 30.15(a)(1)(i), 25 mCi, be changed to

read 27 mCi (1 GBq) to correspond to

the exempt activity of tritium specified

in the IAEA Safety Series No. 115

standard.

NRC practice is to use a dual system

in describing units; the quantities are

given in the SI system, followed by the

quantities in parentheses in

conventional units. This system of units

is used in this final rule wherever

radiation quantities are specified.

However, no change in § 30.15 is being

made at this time so that the quantity

limit will remain as 25 mCi. Regarding

the request to change the total exempt

activity for timepieces to 27 mCi in

place of the 25 mCi now in use, the NRC

is currently involved in an overall

reevaluation of the exemptions from

licensing in 10 CFR Parts 30 and 40,

including § 30.15(a)(1)(i), and will

consider the issue during that process.

The second commenter stated that the

language of § 32.14(d)(1) of the proposed

rule appeared to require 100%

containment of the tritium in watches

using tritium paint. The commenter

proposed alternative text that would

remove this inconsistency and provide

text equally applicable to watches that

utilize either tritium paint or GTLS as

to other exempt products under § 30.15.

This commenter’s suggestion has been

adopted. Section 32.14(d)(1) has been

revised in this final rule. As revised, the

rule requires that the tritium be properly

contained. The commenter also noted

that § 32.14(d)(2) of the proposed rule

did not make sense as presented and

proposed amendatory language that

contains the same concept. The

language proposed by this commenter

has been adopted in the final rule.

Accordingly, the codified text in

§ 32.14(d)(2) has been modified to refer

more correctly to existing prototype

testing requirements for automobile lock

illuminators.

The third commenter remarked that

the wording of the first sentence of the

proposed § 32.14(d)(1) was similar to

the opening sentence of the existing

rule, and that the remainder of the

language of § 32.14(d)(1), which stated

that the performance standard is

satisfied if certain prototype tests

(applicable only to tritium paint) are

satisfied, has been removed. The

commenter noted that the proposed rule

also stated that guidance on specific

prototype testing procedures would be

provided in NUREG–1562, ‘‘Standard

Review Plan for Applications for

Licenses to Distribute Byproduct

Material to Persons Exempt from the

Requirements for an NRC License.’’ The

commenter indicated support for the

increased flexibility provided by the

proposed rule and for the need for clear

and unambiguous means to satisfy

stringent performance requirements

established in the previous § 32.14(d)(1).

The commenter also noted that the

relevant modifications to the guidance

document have not yet been made and

requested that the final promulgation of

the rule be coincident with the issuance

of appropriate guidance. Also this

commenter requested that, because

many timepieces are manufactured

abroad, the NRC acknowledge explicitly

in its guidance that compliance with

relevant international standards is

sufficient to ensure compliance with the

NRC performance standard.

The NRC intends to have the revised

guidance document completed by the

time this rule becomes effective.

Regarding the requirement that

timepieces manufactured abroad should

meet NRC requirements, those

timepieces should fulfill the criteria

specified in NUREG—1562 or its

equivalent.

IV. Agreement State Compatibility

Under the Atomic Energy Act, certain

regulatory functions are reserved to the

NRC. Among these are the distribution

of products to persons exempt from

licensing, as discussed in 10 CFR Part

150. Therefore, this final rule will be an

‘‘NRC’’ Category of compatibility with

regard to the manufacture and initial

distribution of watches and other

products for use under an exemption for

licensing. NRC Category rules address

those regulatory areas which are

reserved to the NRC pursuant to the

Atomic Energy Act and 10 CFR Part 150.

V. Environmental Impact: Categorical

Exclusion

The NRC has determined that this

final rule is the type of action described

as a categorical exclusion in 10 CFR

51.22(c)(2). Therefore, neither an

environmental impact statement nor an

environmental assessment has been

prepared for this final rule.

VI. Paperwork Reduction Act

Statement

This final rule reduces the burden to

applicants for licenses to distribute

timepieces by allowing them to file an

application under the provisions of

§ 32.14 rather than under the provisions

of § 32.22 that, in practice, also requires

that the applicant obtain a registration

certificate. The reduction in burden is

estimated to be 21 hours per response.

Because the application requirements

contained in § 32.14 and § 32.22 are not

being substantively changed, no Office

of Management and Budget (OMB)

clearance is required. Part 32

requirements are approved by the OMB

approval number 3150–0001.

Public Protection Notification

The NRC may not conduct or sponsor,

and a person is not required to respond

to, an information collection unless it

displays a currently valid OMB control

number.

VII. Regulatory Analysis

The NRC has prepared a regulatory

analysis on this final rule. The analysis

examines the costs and benefits of the

revisions provided by the rule and

indicates an annual total cost saving to

the industry to be approximately

$15,000. This regulatory analysis is

available for inspection at the NRC

Public Document Room, 2120 L Street,

NW (Lower Level), Washington, DC.

VIII. Regulatory Flexibility

Certification

As required by the Regulatory

Flexibility Act (5 U.S.C. 605(b)), the

Commission certifies that this rule does

not have a significant economic impact

on a substantial number of small

entities. The NRC has prepared a

regulatory analysis that includes

consideration of the impact of this final

rule on small entities. A copy of this

regulatory analysis is available for

inspection or copying at the NRC Public

Document Room, 2120 L Street, NW

(Lower Level), Washington, DC. The

analysis states that this regulation

would currently affect 10 licensees and

would result in a cost savings for the

industry of approximately $15,000 per

year.
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations 32971

IX . Backfit Analysis

The NRC has determined that the

backfit rule does not apply to this final

rule and, therefore, a Backfit analysis is

not required for this final rule because

these amendments do not involve any

provisions that would impose backfits

as defined in 10 CFR Chapter I.

X. Small Business Regulatory

Enforcement Fairness Act

In accordance with the Small

Business Regulatory Enforcement

Fairness Act of 1996, the NRC has

determined that this action is not a

major rule and has verified this

determination with the Office of

Information and Regulatory Affairs of

OMB.

List of Subjects in 10 CFR Part 32

Byproduct material, Criminal

penalties, Labeling, Nuclear materials,

Radiation protection, Reporting and

recordkeeping requirements.

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 adopting the following amendments

to 10 CFR Part 32.

PART 32—SPECIFIC DOMESTIC

LICENSES TO MANUFACTURE OR

TRANSFER CERTAIN ITEMS

CONTAINING BYPRODUCT MATERIAL

1. The authority citation for Part 32

continues to read as follows:

Authority: Secs. 81, 161, 183, 186, 68 Stat.

935, 948, 953, 954, as amended, (43 U.S.C.

2111, 2201, 2232, 2233); sec.201, 88 Stat.

1242, as amended (42 U.S.C. 5841).

2. In § 32.14, paragraph (d) is revised

to read as follows:

§ 32.14 Certain items containing

byproduct material; requirements for

license to apply or initially transfer.

* * * * *

(d) The Commission determines that:

(1) The byproduct material is properly

contained in the product under the most

severe conditions that are likely to be

encountered in normal use and

handling.

(2) For automobile lock illuminators,

the product has been subjected to and

meets the requirements of the prototype

tests prescribed by § 32.40, Schedule A.

Dated at Rockville, Maryland, this 9th day

of June, 1998.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 98–16014 Filed 6–16–98; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 34

Radiographer Certification—Certifying

Entities

AGENCY: U.S. Nuclear Regulatory

Commission.

ACTION: Notice of certifying entities.

SUMMARY: The U.S. Nuclear Regulatory

Commission (NRC) staff has completed

its evaluation of a request from the

American Society for Nondestructive

Testing, Inc. (ASNT) to be recognized as

a Certifying Entity, i.e., an Independent

Certifying Organization. The NRC staff

found that ASNT’s Industrial

Radiography Radiation Safety Personnel

(IRRSP) certification program meets the

criteria established in the NRC’s

regulations governing radiographic

operations. Therefore, the NRC

recognizes ASNT as a Certifying Entity

and individuals wishing to act as

radiographers who are certified in

isotope radiography through the IRRSP

program meet the certification

requirement specified in the regulations.

ASNT joins the following Agreement

States as certifying entities: Georgia,

Illinois, Iowa, Louisiana, Nevada, North

Dakota, and Texas.

FOR FURTHER INFORMATION CONTACT: J.

Bruce Carrico, U.S. Nuclear Regulatory

Commission, Office of Nuclear Material

Safety and Safeguards, MS T8F5,

Washington, DC 20555, telephone (301)

415–7826, e-mail jbc@nrc.gov.

SUPPLEMENTARY INFORMATION: On May

28, 1997 (62 FR 28948), NRC published

a final rule in the Federal Register that

revised the regulations applicable to

industrial radiography, 10 CFR Part 34.

This overall revision of 10 CFR Part 34

introduced several new requirements.

One of these new requirements,

specified in 10 CFR 34.43(a)(1),

provides that licensees may not permit

any individual to act as a radiographer

until the individual ‘‘is certified through

a radiographer certification program by

a certifying entity in accordance with

the criteria specified in Appendix A of

this part (34).’’ This requirement

becomes effective June 27, 1999.

As defined in 10 CFR Part 34,

‘‘Certifying Entity means an

independent certifying organization

meeting the requirements in Appendix

A of this part or an Agreement State

meeting the requirements in Appendix

A, Parts II and III of this part.’’ An

independent certifying organization is

defined as ‘‘ * * * an independent

organization that meets all of the criteria

of Appendix A to this part.’’ A

parenthetical sentence in 10 CFR

34.43(a)(1) states, ‘‘An independent

organization that would like to be

recognized as a certifying entity shall

submit its request to the Director, Office

of Nuclear Materials Safety and

Safeguards, U.S. Nuclear Regulatory

Commission * * * ’’ Part I of

Appendix A to Part 34 provides the

requirements for an independent

certifying organization, and only applies

to organizations other than the

Agreement States. Parts II and III of

Appendix A to Part 34 provide the

requirements for certification programs

and written examinations for a

certifying entity, and includes the

Agreement States. 10 CFR Part 34,

Appendix A does not impose new

requirements on licensees.

To be recognized as an independent

certifying organization, the organization

should be a national society or

association involved in setting national

standards of practice for industrial

radiography or non-destructive testing.

An acceptable certification program

would require training in the subjects

listed in 10 CFR 34.43(g), completion of

a written and practical examination, and

require a minimum period of on-the-job

experience.

In April 1997, NRC received a

submission from ASNT requesting

recognition as a certifying entity/

independent certifying organization.

The submission described ASNT’s

IRRSP certification program and how

the program complies with 10 CFR Part

34, Appendix A criteria. A ‘‘team’’

review approach was followed in

evaluating the submission. The team or

‘‘working group’’ was composed of three

NRC staff members, two Agreement

State representatives from certifying

states, and an Agreement State

representative from a non-certifying

state. An expert in the NRC’s Office of

Nuclear Reactor Regulation, Division of

Reactor Controls and Human Factors,

Human Factors Assessment Branch also

assisted the working group in evaluating

those portions of the submission

applicable to examination development.

The working group completed its

evaluation of the submission in April

1998.

In a letter dated May 15, 1998, NRC

informed ASNT of its finding that

ASNT’s IRRSP certification program met

the criteria established in 10 CFR Part

34, Appendix A, that ASNT was

recognized as a Certifying Entity.

Individuals wishing to act as

radiographers who are certified in

isotope radiography through the IRRSP

program will meet the certification

requirement specified in 10 CFR

34.43(a)(1).