6312 Federal Register / Vol. 65, No. 27 / Wednesday, February 9, 2000 / Rules and Regulations

made available on the Internet by the

U.S. Government Printing Office. No

comments were received. Accordingly,

no changes are made to the rule as

proposed.

A small business guide on complying

with fruit, vegetable, and specialty crop

marketing agreements and orders may

be viewed at the following web site:

http://www.ams.usda.gov/fv/

moab.html. Any questions about the

compliance guide should be sent to Jay

Guerber at the previously mentioned

address in the FOR FURTHER INFORMATION

CONTACT section.

After consideration of all relevant

matter presented, including the

information and recommendation

submitted by the Committee and other

available information, it is hereby found

that this rule, as hereinafter set forth,

will tend to effectuate the declared

policy of the Act.

List of Subjects in 7 CFR Part 985

Marketing agreements, Oils and fats,

Reporting and recordkeeping

requirements, Spearmint oil.

For the reasons set forth in the

preamble, 7 CFR Part 985 is amended as

follows:

PART 985—MARKETING ORDER

REGULATING THE HANDLING OF

SPEARMINT OIL PRODUCED IN THE

FAR WEST

1. The authority citation for 7 CFR

Part 985 continues to read as follows:

Authority: 7 U.S.C. 601–674.

2. A new § 985.219 is added to read

as follows:

[Note: This section will not appear in the

Code of Federal Regulations.]

§ 985.219 Salable quantities and allotment

percentages—2000–2001 marketing year.

The salable quantity and allotment

percentage for each class of spearmint

oil during the marketing year beginning

on June 1, 2000, shall be as follows:

(a) Class 1 (Scotch) oil—a salable

quantity of 1,211,207 pounds and an

allotment percentage of 65 percent.

(b) Class 3 (Native) oil—a salable

quantity of 1,033,648 pounds and an

allotment percentage of 50 percent.

Dated: February 3, 2000.

Robert C. Keeney,

Deputy Administrator, Fruit and Vegetable

Programs.

[FR Doc. 00–2979 Filed 2–8–00; 8:45 am]

BILLING CODE 3410–02–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 1

[Docket No. 98–043–2]

Field Study; Definition

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending the Animal

Welfare regulations by clarifying the

definition of the term field study. We

will clarify that a field study cannot

involve an invasive procedure, harm the

animals under study, or materially alter

the behavior of the animals under study.

As worded prior to this final rule, the

definition of field study could be

interpreted to mean that a field study

may include one of these situations.

This action will help ensure the proper

use and care of animals used in field

studies.

EFFECTIVE DATE: March 10, 2000.

FOR FURTHER INFORMATION CONTACT: Dr.

Jerry DePoyster, Senior Veterinary

Medical Officer, Animal Care, APHIS,

4700 River Road Unit 84, Riverdale, MD

20737–1228; (301) 734–7586.

SUPPLEMENTARY INFORMATION: The

Animal Welfare Act (AWA) (7 U.S.C.

2131 et seq.) authorizes the Secretary of

Agriculture to promulgate standards and

other requirements governing the

humane handling, housing, care,

treatment, and transportation of certain

animals by dealers, research facilities,

exhibitors, carriers, and intermediate

handlers.

The regulations established under the

Act are contained in title 9 of the Code

of Federal Regulations, chapter I,

subchapter A, parts 1, 2, and 3. Part 1

defines various terms used in parts 2

and 3.

As defined in § 1.1 of the regulations

prior to this final rule, field study meant

any study that is ‘‘conducted on freeliving wild animals in their natural

habitat, which does not involve an

invasive procedure, and which does not

harm or materially alter the behavior of

the animals under study.’’

We have always intended that field

studies not include any invasive

procedures, harm the animals under

study, or materially alter the behavior of

the animals under study. However, we

were concerned that the definition, as

worded above, could be interpreted to

mean that a field study could include

any one of these situations.

On July 31, 1998, we published in the

Federal Register (63 FR 40844–40845,

Docket No. 98–043–1) a proposal to

amend the definition of field study in

§ 1.1 of the regulations by defining field

study as any study conducted on freeliving wild animals in their natural

habitat. We also proposed to add the

provision that the term field study

excludes any study that involves an

invasive procedure or has the potential

to harm or materially alter the behavior

of the animals under study. This

proposed action was based on the need

to ensure that studies conducted in freeliving wild animals in their natural

habitat are correctly classified as field

studies based on the definition of field

study.

We solicited comments concerning

our proposal for 60 days ending

September 29, 1998. We received seven

comments. They were from universities;

animal welfare organizations; an

association representing birds; an

association representing fish, reptiles,

and amphibians; and an association

representing zoos and aquariums. Two

commenters supported the proposal as

written. However, one of these

commenters and the remaining

commenters had concerns that are

discussed below.

One commenter stated that the

previous definition of field study was

perfectly clear and unambiguous and

did not need to be amended. In

addition, two commenters stated that

the proposed change in the definition of

field study would exclude all projects

that involve invasive procedures. One

commenter requested that we delay the

change of the definition. Two

commenters stated that any study has

the potential to harm or materially alter

the behavior of the animals under study;

therefore, no study could be classified

as a field study.

We do not believe that the previous

definition was clear to everyone. For

instance, two commenters stated that

the proposed change in the definition of

field study would exclude all projects

that involve invasive procedures.

However, the previous definition of

field study always excluded studies that

involved invasive procedures, harmed

the animals under study, or materially

altered the behavior of the animals

under study. In addition, in the past,

some entities interpreted the definition

to mean that a field study may include

any one of these situations as long as it

did not include all of them. In our

proposed definition of field study, we

clarified that a study that includes any

one of the situations could not be

considered a field study.

As to the use of the word potential,

we agree that it is unnecessary;

therefore, we are removing the word

Federal Register / Vol. 65, No. 27 / Wednesday, February 9, 2000 / Rules and Regulations 6313

potential from the definition of field

study in this final rule.

One commenter stated that the

definition is internally inconsistent. The

commenter stated that if a field study is

any study conducted on free-living wild

animals in their natural habitat

(emphasis added), then the second part

of our definition, which excludes a

subset of those studies (those that

involve invasive procedures or have the

potential to harm or materially alter the

behavior of an animal), does not make

sense.

This is a question of sentence

structure, which we have addressed in

this final rule by changing the word

‘‘any’’ in the first sentence to ‘‘an’’ and

beginning the second sentence with

‘‘However,’’. We believe that this change

solves the sentence structure problem.

One commenter stated that the words

‘‘harm,’’ ‘‘invasive,’’ and ‘‘materially

alter’’ should be defined or else the

determination of whether a study

should be classified as a field study will

be left to the discretion of the

Institutional Animal Care and Use

Committee (IACUC) at different

facilities. One commenter stated that the

Animal and Plant Health Inspection

Service (APHIS) should provide

definitions for invasive or noninvasive,

and one commenter stated that APHIS

should provide guidelines or regulations

for defining invasive procedure and

standard animal husbandry procedures.

In addition, one commenter stated that

APHIS should issue guidelines or a

policy to state what the Agency

classifies as a field study.

We do not believe that the terms

‘‘harm,’’ ‘‘invasive,’’ and ‘‘materially

alter’’ need to be defined. However, we

are considering the development of a

policy statement that would provide

examples of what APHIS considers

invasive or noninvasive procedures. We

do not believe that guidelines or

regulations for defining standard animal

husbandry procedures are necessary.

Standard animal husbandry procedures

are procedures that are necessary for the

health and maintenance of animals on a

premises.

One commenter stated that the

proposed definition of field study

obscures rather than clarifies the intent

of field studies. This commenter stated

that restriction of the term field study to

exclude invasive procedures does not

clarify the definition. This commenter

stated that field studies have no

inherent implication of invasiveness

and should retain the common and

professional meaning of ‘‘the study of

organisms in the field,’’ and after

classification as a field study, the study

should then be qualified as invasive or

noninvasive.

The term field study has always

excluded any study that involved an

invasive procedure; therefore, we have

not altered the intent of the definition.

In order to be absolutely clear as to what

constitutes a field study, the definition

of field study had to provide the

situations that would exclude a study

from being considered a field study

under the AWA regulations.

One commenter requested

clarification that our proposal would

not make changes in the administration

of the AWA regulations by APHIS and

IACUC’s and that it would not prohibit

or restrict field studies or impose

additional requirements on researchers.

We only clarified the definition of

field study by removing the word ‘‘and’’

and any ambiguity created by the word

‘‘and.’’ We did not make substantive

changes, prohibit or restrict field

studies, or impose additional

requirements on researchers.

One commenter stated that the

composition of the members of the

IACUC can vary greatly and the

expertise of the membership may not

represent all disciplines that are subject

to review. This commenter further

stated that the IACUC may not have

members experienced in the activities

commonly conducted in field studies or

experience in performing certain

procedures under field conditions.

Another commenter stated that most

IACUC’s do not include field

researchers who are able to appreciate

the unique conditions of field research.

One commenter stated that a growing

number of investigators, institutions,

and granting agencies require any

research use of animals in the field or

laboratory to be reviewed by their

IACUC, and self-determination by the

investigator does not protect him or her

or the institution, nor does it provide for

consistent peer-reviewed determination

of invasive procedures.

Comments regarding the membership

and function of IACUC’s are beyond the

scope of this rule; however, in

accordance with § 2.31(a) of the

regulations, the Chief Executive Officer

of the research facility is responsible for

appointing the members of the IACUC.

Members of the IACUC are required to

have the experience and expertise to

assess the research facility’s animal

programs, facilities, and procedures,

including the review of all proposed

and ongoing research projects.

The principal investigator is

responsible for determining whether a

study is a field study. If the principal

investigator reviews a field study

protocol and has questions regarding

whether a procedure is invasive or

noninvasive, the investigator can

consult with the IACUC of the facility.

In addition, in accordance with the

regulations in § 2.31(c)(1), at least once

every 6 months the IACUC must review

the research facility’s program for the

humane care and use of animals by

using the AWA regulations as a basis for

evaluation. Therefore, if a study is

misclassified as a field study, the

IACUC will have the opportunity to take

action to reclassify the study.

One commenter stated that there are

studies that involve implantation of

transponders or radiotransmitters and

procedures, such as marking the

animals with minor clipping or

branding, that could technically be

considered invasive procedures and are

not conducted under sterile conditions.

The commenter further stated that

trauma to subjects is minimized by

reducing the handling time.

An invasive procedure is typically

one in which the living animal is

entered by either perforation or incision

in a manner that could cause more than

short-lived pain or distress and may

materially alter the behavior of the

animal for more than a short period of

time. For instance, opening the body

cavity of an animal would be considered

invasive and could cause the animal to

materially alter its behavior until

completely healed from the surgery.

However, implantations of microchips

and transponders may not be invasive

depending on the site and method of

implantation.

One commenter asked if a facility that

is currently licensed as an exhibitor

under the AWA would have to register

as a research facility if an employee is

approved to initiate a noninvasive

research project in the field. The

commenter stated that it was unclear

when a research project is considered a

regulated research project.

If the research project meets the

definition of field study, the research

project would not fall under the AWA

regulations. However, if the research

project does not meet the definition of

field study (i.e., includes an invasive

procedure, harms, or materially alters

the behavior of the animals) the research

project would need to be regulated

under the AWA, and the facility would

need to be registered as a research

facility.

One commenter stated that he could

not locate the statutory authority given

to the U.S. Department of Agriculture

(USDA) over animal care in the wild,

whether or not the animals are involved

in research. The commenter stated that

the AWA assigns APHIS authority over

specific warm-blooded animals on

6314 Federal Register / Vol. 65, No. 27 / Wednesday, February 9, 2000 / Rules and Regulations

public display or intended for use in

research facilities (7 U.S.C. 2131). The

commenter added that it is not clear

how USDA has authority if the

noninvasive research does not involve

animals or activities that are in

interstate or foreign commerce or does

not substantially affect such commerce

or its free flow as provided in the AWA

(7 U.S.C. 2131).

The purpose of defining the term field

study in our regulations is to exclude

from the regulations those activities that

meet the definition. Thus, if a study is

conducted on free-living wild animals

in their natural habitat and the study

does not involve an invasive procedure,

does not harm the animals under study,

and does not materially alter the

behavior of the animals under study,

then that activity is not regulated.

The AWA defines animal as any live

or dead dog, cat, nonhuman primate,

guinea pig, hamster, rabbit, or such

other warm-blooded animal as the

Secretary may determine is being used,

or is intended for use, for research,

testing, experimentation, or exhibition

purposes, or as a pet. This definition

does not exclude animals in the wild. If

a research facility conducts a study on

animals in the wild that does not meet

the criteria for a field study, then that

activity would be regulated. The AWA

defines research facility as any school

(except an elementary or secondary

school), institution, organization, or

person that uses or intends to use live

animals in research, tests, or

experiments and that: (1) Purchases or

transports live animals in commerce; or

(2) receives funds under a grant, award,

loan, or contract from a department,

agency, or instrumentality of the United

States for the purpose of carrying out

research, tests, or experiments. * * *’’

One commenter stated that

researchers appear to be circumventing

the AWA by claiming that trap tests

performed on wildlife are field studies.

Trapping, including the testing of traps,

is not regulated by the AWA.

Therefore, for the reasons given in the

proposed rule and in this document, we

are adopting the proposed rule as a final

rule, with the changes discussed in this

document.

Executive Order 12866 and Regulatory

Flexibility Act

This final rule has been reviewed

under Executive Order 12866. The rule

has been determined to be not

significant for the purposes of Executive

Order 12866 and, therefore, has not

been reviewed by the Office of

Management and Budget.

This final rule will clarify that a field

study cannot include an invasive

procedure, harm the animals under

study, or materially alter the behavior of

the animals under study.

We have always intended that field

studies not include any invasive

procedures, harm the animals under

study, or materially alter the behavior of

the animals under study. This rule

makes no substantive changes to the

definition. By clarifying the definition

of field study, this final rule will help

ensure that studies that should be

covered under the Animal Welfare

regulations are covered.

The only entities that will be affected

by this rule will be entities that perform

studies conducted on free-living wild

animals in their natural habitat. We

estimate that at least 50 entities may be

affected by this final rule. These entities

may be considered small and large

entities by Small Business

Administration standards, but this final

rule will only affect a small portion of

the entities’ activities. As we are not

proposing a substantive change in the

definition, the effect on these entities

will not be significant.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action will not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

Executive Order 12988

This final rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. It is not intended to

have retroactive effect. This rule would

not preempt any State and local laws,

regulations, or policies, unless they

present an irreconcilable conflict with

this rule. The Act does not provide

administrative procedures which must

be exhausted prior to a judicial

challenge to the provisions of this rule.

Paperwork Reduction Act

This proposed rule contains no

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

List of Subjects in 9 CFR Part 1

Animal welfare, Pets, Reporting and

recordkeeping requirements, Research.

Accordingly, we are amending 9 CFR

part 1 as follows:

PART 1—DEFINITION OF TERMS

1. The authority citation for part 1

continues to read as follows:

Authority: 7 U.S.C. 2131–2159; 7 CFR

2.22, 2.80, and 371.2(g).

2. In § 1.1, the definition of field study

is revised to read as follows:

§ 1.1 Definitions.

* * * * *

Field study means a study conducted

on free-living wild animals in their

natural habitat. However, this term

excludes any study that involves an

invasive procedure, harms, or materially

alters the behavior of an animal under

study.

* * * * *

Done in Washington, DC, this 3rd day of

February 2000.

Richard L. Dunkle,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–2922 Filed 2–8–00; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF ENERGY

10 CFR Part 708

RIN 1901–AA78

Criteria and Procedures for DOE

Contractor Employee Protection

Program

AGENCY: Office of Hearings and Appeals,

Department of Energy.

ACTION: Final rule.

SUMMARY: The Department of Energy

(DOE) adopts, with minor changes, an

interim final rule published on March

15, 1999, to amend the DOE contractor

employee protection program

(‘‘whistleblower’’) regulations.

EFFECTIVE DATE: This final rule is

effective on March 10, 2000.

FOR FURTHER INFORMATION CONTACT:

Roger Klurfeld, Assistant Director, or

Thomas O. Mann, Deputy Director,

Office of Hearings and Appeals,

Department of Energy, 1000

Independence Ave., SW, Washington,

DC 20585–0107; telephone: 202–426–

1449; e-mail: roger.klurfeld@hq.doe.gov,

thomas.mann@hq.doe.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

On March 15, 1999, DOE published

an interim final rule in the Federal

Register (64 FR 12862) that

comprehensively revised the regulations

for the DOE contractor employee

protection program, which are codified