Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Proposed Rules 34599

that everyone wishing to speak has the

opportunity.

The purpose of the hearings is to give

interested persons an opportunity for

oral presentation of data, views, and

arguments. Questions about the content

of the proposed rule may be part of the

commenters’ oral presentations.

However, neither the presiding officer

nor any other representative of APHIS

will respond to comments at the

hearing, except to clarify or explain

provisions of the proposed rule.

Authority: 21 U.S.C. 111, 114, 114a, 115–

117, 120, 121, 134b, and 134f; 7 CFR 2.22,

2.80, and 371.2(d).

Done in Washington, DC, this 25th day of

May 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–13589 Filed 5–30–00; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 112

[Docket No. 96–034–2]

Viruses, Serums, Toxins, and

Analogous Products; Packaging and

Labeling

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule; withdrawal.

SUMMARY: We are withdrawing a

proposed rule to amend the regulations

regarding the packaging and labeling of

veterinary biological products. The

proposed rule would have required the

Animal and Plant Health Inspection

Service product code number as well as

an appropriate consumer contact

telephone number to appear on labeling.

In addition, the proposed rule would

have clarified label requirements with

respect to overshadowing the true name

of the product and requirements for

products shipped to a foreign country.

The proposed rule also contained label

requirements concerning the minimum

age for product administration and the

potential for maternal antibody

interference. We are withdrawing the

proposed rule due to the comments we

received following its publication.

FOR FURTHER INFORMATION CONTACT: Dr.

Albert P. Morgan, Chief Staff Officer,

Operational Support Section, Center for

Veterinary Biologics, Licensing and

Policy Development, APHIS, 4700 River

Road Unit 148, Riverdale, MD 20737–

1231; (301) 734–8245.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 112 set

forth packaging and labeling

requirements for veterinary biological

products. On March 18, 1999, we

published in the Federal Register (64

FR 13365–13368, Docket No. 96–034–1)

a proposed rule to amend the

regulations. First, we proposed to

require labels for veterinary biological

products to include the Animal and

Plant Health Inspection Service (APHIS)

product code number and a consumer

contact telephone number. Second, we

proposed to require labels for veterinary

biological products to bear the true

name of the product in a prominent

fashion and more prominently than the

trade name. Third, we proposed to

amend the requirements for labels for

exported products to state that labels

that do not conform to the regulations

may be used with an exported product

if the labels do not contain false or

misleading information and are

acceptable to the appropriate regulatory

officials of the foreign country to which

the products are exported. We proposed

that verification of foreign regulatory

acceptance of the labels could be

supplied to APHIS through the

submission of a label mounting

prepared as described in § 112.5(d)(2)

that bears a stamp or other mark of

approval of the appropriate foreign

regulatory agency. Finally, we proposed

to require labels for veterinary biological

products, as described in the proposed

rule, to consider the potential for

maternal antibody interference with

product efficacy and to specify a

minimum age for product

administration that is consistent with

the efficacy and safety data developed

for the product.

We solicited comments concerning

our proposal for 60 days ending May 17,

1999. We received 11 comments by that

date. The comments were from licensed

veterinary biologics manufacturers, a

national trade association representing

U.S. manufacturers of animal health

products, an organization representing

veterinarians, and a university. Most of

the commenters expressed concerns and

opposition regarding certain provisions

of the proposed rule, including concerns

regarding the economic effects of the

proposed provisions on veterinary

biologics manufacturers and the

estimated burden for information

collection that was provided in the

Paperwork Reduction Act section of the

proposed rule.

After considering all of the comments

we received, we have concluded that we

must reevaluate the provisions of the

proposed rule. Therefore, we are

withdrawing the March 18, 1999,

proposed rule referenced above. The

concerns and recommendations of all of

the commenters will be considered if

any new proposed regulations regarding

the packaging and labeling of veterinary

biological products are developed.

Authority: 21 U.S.C. 151–159; 7 CFR 2.22,

2.80, and 371.2(d).

Done in Washington, DC, this 24th day of

May 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–13549 Filed 5–30–00; 8:45am]

BILLING CODE 3410–34–U

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 50

[Docket No. PRM–50–71]

Nuclear Energy Institute; Receipt of

Petition for Rulemaking

AGENCY: Nuclear Regulatory

Commission.

ACTION: Petition for rulemaking; Notice

of receipt.

SUMMARY: The Nuclear Regulatory

Commission (NRC) has received and

requests public comment on a petition

for rulemaking filed by the Nuclear

Energy Institute. The petition was

docketed on April 12, 2000, and has

been assigned Docket No. PRM–50–71.

The petitioner requests that the NRC

amend its regulations to allow nuclear

power plant licensees to use zirconiumbased cladding materials other than

zircaloy or ZIRLO, provided the

cladding materials meet the

requirements for fuel cladding

performance and have received

approval by the NRC staff. The

petitioner believes the proposed

amendment would improve the

efficiency of the regulatory process by

eliminating the need for individual

licensees to obtain exemptions to use

advanced cladding materials which

have already been approved by the NRC.

DATES: Submit comments by August 14,

2000. 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 comments to:

Secretary, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001, Attention: Rulemakings and

Adjudications Staff.

34600 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Proposed Rules

Deliver comments to: 11555 Rockville

Pike, Rockville, Maryland, between 7:30

a.m. and 4:15 p.m. on Federal workdays.

For a copy of the petition, write to

David L. Meyer, Chief, Rules and

Directives Branch, Division of

Administrative Services, Office of

Administration, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001.

The petition, this notice of receipt,

and any comments received on the

petition are available on the NRC’s

rulemaking website at http://

ruleforum.llnl.gov. This site also

provides the capability to upload

comments as files (any format), if your

web browser supports that function. For

information about the interactive

rulemaking website, contact Ms. Carol

Gallagher, (301) 415–5905 (email:cag@nrc.gov).

FOR FURTHER INFORMATION CONTACT:

David L. Meyer, Chief, Rules and

Directives Branch, Division of

Administrative Services, Office of

Administration, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001, Telephone: 301–415–7162 or Toll

Free: 1–800–368–5642 or email:

DLM1@nrc.gov.

SUPPLEMENTARY INFORMATION:

The Petitioner

The petitioner is the Nuclear Energy

Institute (NEI). NEI claims

representational responsibility for

establishing unified nuclear industry

policy on matters affecting the nuclear

energy industry, including regulatory

aspects of generic operational and

technical issues. NEI’s members include

all utilities licensed to operate

commercial nuclear power plants in the

United States, nuclear plant designers,

major architect/engineering firms, fuel

fabrication facilities, materials licensees,

and other organizations and individuals

involved in the nuclear energy industry.

The Petitioner’s Request

The petitioner states that the NRC’s

current regulations require uranium

oxide fuel pellets, used in commercial

reactors, be contained in cladding

material made of zircaloy or ZIRLO. The

petitioner indicates that the requirement

to use either of these materials is stated

in 10 CFR 50.44 and 10 CFR 50.46.

The petitioner notes that subsequent

to promulgation of these regulations,

commercial fuel vendors have

developed and continue to develop

materials other than zircaloy or ZIRLO

that NRC reviews and approves for use

in commercial power reactors. Each of

these approvals requires the NRC to

grant an exemption to the license of the

utility that requests use of fuel in these

cladding materials. The petitioner

requests that NRC amend its regulations

to allow licensees discretion to use

zirconium-based cladding materials

other than zircaloy or ZIRLO, provided

that the cladding materials meet the fuel

cladding performance requirements and

have been reviewed and approved by

NRC staff.

Petitioner’s Interest

The petitioner states that safe and

reliable operation of nuclear power

plants, including fuel performance is

very important to its members, the

country, and the international

community. The petitioner states that

the NRC regulates the use of radioactive

materials and allows nuclear power

plant licensees to use a variety of

cladding materials once the material has

been determined to have the required

characteristics. The petitioner states that

for the past nine years, NRC has

permitted the use of cladding materials

other than zircaloy or ZIRLO after

approving a formal exemption request.

The petitioner further notes there have

been at least eight requests for

exemptions during that time frame and

each exemption costs in excess of

$50,000. The petitioner states that the

requests for exemption have become

increasingly more frequent, causing

significant administrative confusion and

a potentially adverse affect on efficient

and effective use of NRC, licensee, and

vendor resources.

Justification for Petition

Sections A through D below contain

the detailed discussion provided by the

petitioner to support his request. The

text contained in each of these sections

reflects the petitioner’s point of view

word for word.

A. The Current Regulation Given the

Diversity of Commercially Available

Fuel Cladding Materials is too Narrow

and Restrictive

The beneficial use of zirconium (Zr)

has been recognized for many years. It

has a very low neutron cross-section

when separated from hafnium with

which it is typically found in nature. It

also has excellent corrosion resistance

to oxidizing environments, such as

steam and water. Certain impurities

were found to decrease this corrosion

resistance and early programs were

established to develop alloys that

produced more consistent corrosion

resistance.

Primary additives were tin, as used

initially in a variety of zirconium-based

alloys commonly referred to as zircaloy,

and niobium (Nb) favored in Canada

and Russia.

Beginning in approximately the mid1980’s, nuclear fuel vendors began

developing new alloy variations to

improve cladding corrosion resistance

in support of higher burnup fuel

management strategies. The new alloy

variants were initially within the ASTM

[American Society for Testing and

Materials] specifications for existing

zirconium-based cladding. As fuel cycle

burnups were projected to increase

further, additional alloys were

developed, some of which involved

formulations outside the ASTM

specifications for existing cladding

material.

The tin (Sn) additive-based alloys

were generally favored in the U.S. and

were successfully developed in both

BWR [boiling water reactor] and PWR

[pressurized water reactor] reactors.

Early Zr-Sn alloys tended to use

relatively high tin concentrations until

long term corrosion tests showed that

there was an increase in the corrosion

rate as a function of time. Subsequent

developments of the alloy, currently

defined as Zircaloy-2 and Zircaloy-4,

limited tin concentration to between 1.2

percent and 1.7 percent. Most of the

early zircaloy compositions were at a

nominal 1.5 percent Sn. Subsequent

testing of the alloy in high rated PWR

plants has shown that the lower tin

concentrations provide even better

performance. Current zircaloy

compositions tend to focus on a mean

Sn composition of about 1.3 percent.

That value has been established by

producers to minimize the risk of

manufacturing a product below the

ASTM specified range. However, there

is significant data to show that lower Sn

compositions would provide even better

corrosion resistance.

Excellent corrosion performance has

also been achieved with the niobium

additive-based alloys; however, these

appear to be more sensitive to the

coolant composition. For example, the

corrosion resistance is superior to the

tin additive-based alloy under PWR

environments but tends to suffer from

nodular-type oxidation under BWR

conditions. The alloy is much less

temperature sensitive and the oxide

thickness is generally less than that of

the corresponding corrosion layer on

zircaloy irradiated under identical

conditions. The optimum niobium

content is probably about one percent,

or such as is found in M5 or ZIRLO

cladding alloys.

The major variant on the Zr-Sn and

Zr-Nb systems is the Zr-Sn-Nb system

developed in the US as ZIRLO and in

Russia as E635.

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Proposed Rules 34601

As a result of these development

programs, cladding materials now

available include zircaloy, ZIRLO, Alloy

A, M5, and Duplex. All of these alloys

are zirconium-based. Since zircaloy and

ZIRLO are currently the only cladding

materials provided for in the

regulations, utilities must obtain an

exemption from the applicable

regulatory requirements to use these

other cladding materials. Exemption

requests will become more frequent as

use of new cladding materials becomes

more prevalent. Once a specific

cladding material is approved for use by

NRC, the subsequent exemption

requests do not increase safety or

confidence in the performance of the

cladding. They are strictly an

administrative process necessitated by

the restrictive language of the current

regulations.

The rule should be modified to

address the currently available alloys as

well as those that may be developed in

the future.

B. A More General Description of

Cladding Material Facilitates Technical

Improvements

Currently, a licensee desiring to use

fuel with cladding materials other than

zircaloy or ZIRLO must obtain NRC

approval through an exemption request.

The time delay in obtaining approval as

well as expenses incurred in preparing

exemption requests might cause some

licensees to defer adopting new

cladding materials despite performance

advantages to be gained. The proposed

amendments would permit use of

improved cladding materials without

expending NRC, licensee, and vendor

resources to develop, review, and

approve exemption requests for

cladding materials that fully meet NRC

performance requirements.

Since the current industry interest

focuses on cladding materials for which

the performance criteria in § 50.46(b)

remain applicable, a new § 50.46(e) is

proposed that provides a clear tie

between the approved cladding material

alloy mentioned in §§ 50.44 and 50.46

with the criteria noted in § 50.46(b).

Similarly, to facilitate technical

innovation, the NRC staff often

encourages licensees and vendors to

conduct Lead Test Assembly (LTA)

Programs to demonstrate the

performance of the new fuel assembly

materials. It has been the past practice

of the NRC not to require licensees to

obtain approval of the LTA Program

before placing the LTAs in the reactor.

It is not the intent of industry to change

that practice by making reference to

approved cylindrical zirconium-based

alloys in §§ 50.44 and 50.46.

C. The Regulation as Applied to Nuclear

Power Plant Fuel Loading Incurs

Unwarranted Implementation Costs

The implication of the current rule

language that only the use of zircaloy or

ZIRLO clad fuel is appropriate requires

utilities to request, and NRC to approve,

exemptions to use other cladding

materials. Each exemption request is

estimated to cost approximately

$50,000, exclusive of NRC’s cost. It is

also estimated that the proposed change

to the regulations could avoid at least

thirty exemption requests over the next

8 to 9 years.

D. The Proposed Amendment Allows

the Use of Alternative Materials That

Meet the Cladding Performance

Requirements

The existing regulations address only

zircaloy and ZIRLO cladding materials.

The regulation needs to be generalized

to avoid unnecessary burdens on the

developers of new cladding alloys and

utilities who will use those alloys. The

language of this proposed amendment

will encompass all zirconium-based

cladding material for which the ECCS

performance criteria of § 50.46(b) are

applicable.

The proposed wording does not

eliminate current NRC practices

regarding review and approval of new

cladding materials brought forward by

fuel vendors. It does permit the NRC

regulation to be more efficiently applied

to those cladding materials

demonstrated to meet the acceptance

criteria of §§ 50.46(b)(1) and (b)(2).

Experience has shown that

qualification of an acceptable material

can only be achieved by testing. An

applicant must perform hightemperature oxidation and quenching

tests of the cladding material to

demonstrate that the 2200-degrees F

peak cladding temperature and 17

percent oxidation limits protect the

cladding against embrittlement and

prevent the oxidation from becoming

autocatalytic. This is demonstrated by

heating the cladding to various high

temperatures for a variety of time

periods and quickly quenching the

cladding in a cold water bath.

These tests must demonstrate that

failure did not occur until beyond the

temperature limits and that no

autocatalytic oxidation was observed.

As long as the tests confirm that the

2200-degrees F and 17 percent oxidation

are conservative for the cladding

material, then the material design is

acceptable for LOCA [loss-of-coolant

accident] licensing analyses up to

currently approved burn up limits.

Providing a new more general

description of the fuel cladding is

consistent with the NRC movement

toward a performance-based, rather than

prescriptive, regulatory philosophy.

Conclusion

The petitioner believes the foregoing

reasons support why NRC should

amend §§ 50.44 and 50.46, as stated

above, to allow the use of other

zirconium-based alloys in addition to

those specified in the current regulation.

The petitioner recognizes that the

stated goal of the existing regulations is

to ensure adequate coolability for

reactor fuel in case of a design-basis

accident. However, the petitioner asserts

that the proposed amendment does not

degrade the ability to meet that goal.

Rather, it removes an unwarranted

licensing burden without increasing risk

to public health and safety.

Proposed Amendments

According to the petitioner, the

proposed amendments would continue

to allow nuclear power plant licensees

the discretion to use zircaloy or ZIRLO

cladding to encase the uranium dioxide

fuel pellets. The proposed amendments

also would allow nuclear power plant

licensees to use other cladding materials

with material properties that meet

accepted requirements for fuel cladding

performance. The petitioner identifies

the proposed amendments as follows:

PART 50—[AMENDED]

1. Section 50.44, paragraphs (a), (b),

and (c)(1) are revised to read as follows:

§ 50.44 Standards for combustible gas

control system in light-water-cooled nuclear

power reactors.

(a) Each boiling or pressurized lightwater nuclear power reactor fueled with

oxide pellets within approved

cylindrical zirconium-based alloy

cladding, must . . .

(b) Each boiling or pressurized lightwater nuclear power reactor fueled with

oxide pellets within approved

cylindrical zirconium-based alloy

cladding must . . .

(c)(1) For each boiling or pressurized

light-water nuclear power reactor fueled

with oxide pellets within approved

cylindrical zirconium-based alloy

cladding, it must be shown that . . .

2. Section 50.46(a)(1)(i) is revised to

read as follows:

§ 50.46 Acceptance criteria for emergency

core cooling systems for light-water nuclear

power reactors.

(a)(1)(i) Each boiling or pressurized

light-water nuclear power reactor fueled

with uranium oxide pellets within

approved cylindrical zirconium-based

alloy cladding must be provided with an

34602 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Proposed Rules

emergency core cooling system (ECCS)

that must be designed so that its

calculated cooling performance

following postulated loss-of-coolant

accidents conforms to the criteria set

forth in paragraph (b) of this section.

...

3. In Section 50.46, a new paragraph

(e) is added to read as follows:

(e) Approved cylindrical zirconiumbased alloys are those whose

performance has been evaluated and

determined by the NRC to conform to

the acceptance criteria of paragraphs

§ 50.46(b)(1) and (b)(2).

Dated at Rockville, Maryland this 24th day

of May, 2000.

For the Nuclear Regulatory Commission.

Annette L. Vietti-Cook,

Secretary of the Commission.

[FR Doc. 00–13515 Filed 5–30–00; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 2000–NE–15–AD]

RIN 2120–AA64

Airworthiness Directives; Turbomeca

Artouste II and Artouste III Series

Turboshaft Engines

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

adoption of a new airworthiness

directive (AD) that is applicable to

Turbomeca Artouste II and Artouste III

series turboshaft engines. This proposal

would require installation of

modification TU 24, TU 167 or TU 164,

depending on the specific engine model.

These modifications would prevent

uncommanded partial closing or total

closing of the electrical fuel cock, which

would prevent uncommanded in-flight

engine shutdown. From the effective

date of this AD, and until the

modifications are installed, this

proposal would also limit the duration

of the engine operating cycle. This

proposal is prompted by reports of

unexpected power loss during test

flights. The actions specified by the

proposed AD are intended to prevent

unexpected power loss, which could

result in an uncommanded in-flight

engine shutdown, autorotation, and

forced landing.

DATES: Comments must be received by

July 31, 2000.

ADDRESSES: Submit comments to the

Federal Aviation Administration (FAA),

New England Region, Office of the

Regional Counsel, Attention: Rules

Docket No. 2000–NE–15–AD, 12 New

England Executive Park, Burlington, MA

01803–5299. Comments may also be

submitted to the Rules Docket by using

the following Internet address: ‘‘9-aneadcomment@faa.gov’’. Comments may

be inspected at this location between

8:00 a.m. and 4:30 p.m., Monday

through Friday, except Federal holidays.

The service information referenced in

the proposed rule may be obtained from

Turbomeca, 40220 Tarnos, France;

telephone 33 05 59 64 40 00, fax 33 05

59 64 60 80. This information may be

examined at the FAA, New England

Region, Office of the Regional Counsel,

12 New England Executive Park,

Burlington, MA.

FOR FURTHER INFORMATION CONTACT:

Glorianne Niebuhr, Aerospace Engineer,

Engine Certification Office, FAA, Engine

and Propeller Directorate, 12 New

England Executive Park, Burlington, MA

01803–5299, telephone (781) 238–7132,

fax (781) 238–7199.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Communications

should identify the Rules Docket

number and be submitted to the address

specified above. All communications

received on or before the closing date

for comments, specified above, will be

considered before taking action on the

proposed rule. The proposals contained

in this notice may be changed in light

of the comments received.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the proposed rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report

summarizing each FAA-public contact

concerned with the substance of this

proposal will be filed in the Rules

Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this notice

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 2000–NE–15–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Availability of NPRMs

Any person may obtain a copy of this

NPRM by submitting a request to the

FAA, New England Region, Office of the

Regional Counsel, Attention: Rules

Docket No. 2000–NE–15–AD, 12 New

England Executive Park, Burlington, MA

01803–5299.

Discussion

The Director General de L’Aviation

Civile (DGAC), which is the

airworthiness authority for France,

recently notified the Federal Aviation

Administration (FAA) that an unsafe

condition may exist on Turbomeca

Artouste II and Artouste III series

turboshaft engines. The DGAC advises

that it has received reports of

unexpected power loss in service. This

power loss is due to closing of the

electrical fuel cock. This condition, if

not corrected, could result in

unexpected power loss, which could

result in an uncommanded in-flight

engine shutdown, autorotation, and

forced landing.

Service Information

Turbomeca has issued Artouste II

Service Bulletin (SB) No. 223 72 0070,

dated January 21, 1999, that specifies

procedures for installing modification

TU 24, which provides an equipped

relay inside the control unit. Turbomeca

has also issued Artouste III SB No. 218

80 0098, dated January 14, 1999 and SB

No. 218 80 0093, Revision 2, dated

January 14, 1999 which state similar

requirements and specify procedures for

installation of modifications TU 164 and

TU 167 respectively. The DGAC

classified these SB’s as mandatory and

issued Airworthiness Directive (AD)

1999–005(A), dated January 13, 1999,

and AD 1999–090(A), dated February

24, 1999, in order to ensure the

airworthiness of these engines in

France.

Bilateral Airworthiness Agreement

This engine model is manufactured in

France and is type certificated for

operation in the United States under the

provisions of Section 21.29 of the

Federal Aviation Regulations (14 CFR

21.29) and the applicable bilateral

airworthiness agreement. Pursuant to

this bilateral airworthiness agreement,

the DGAC has kept the FAA informed

of the situation described above. The

FAA has examined the findings of the

DGAC, reviewed all available

information, and determined that AD

action is necessary for products of this

type design that are certificated for

operation in the United States.