[Federal Register Volume 65, Number 23 (Thursday, February 3, 2000)]
[Notices]
[Pages 5301-5303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2382]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 65, No. 23 / Thursday, February 3, 2000 / 
Notices  

[[Page 5301]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-116-2]


Animal Welfare; Farm Animals Used for Nonagricultural Purposes

AGENCY:  Animal and Plant Health Inspection Service, USDA.

ACTION:  Notice.

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SUMMARY:  We are adopting two guides: The ``Guide for the Care and Use 
of Agricultural Animals in Agricultural Research and Teaching,'' 
published by the Federation of Animal Science Societies, and the 
``Guide for the Care and Use of Laboratory Animals,'' published by the 
Institute of Laboratory Animal Resources. We are adopting these guides 
to assist regulated entities in meeting the standards in the 
regulations as they apply to the handling, care, treatment, and 
transportation of farm animals used for nonagricultural purposes 
(primarily research and exhibition). The recommendations in these 
guides represent the most current thinking on appropriate practices for 
the handling, care, treatment, and transportation of farm animals for 
nonagricultural purposes.

EFFECTIVE DATE:  March 6, 2000.

FOR FURTHER INFORMATION CONTACT:  Dr. Richard Watkins, Animal Care, 
APHIS, USDA, 4700 River Road Unit 84, Riverdale, MD 20737-1234; (301) 
734-4981.

SUPPLEMENTARY INFORMATION:

Background

    The Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.) authorizes the 
Secretary of Agriculture to promulgate standards governing the humane 
handling, care, treatment, and transportation of certain animals by 
dealers, exhibitors, and other regulated entities. The Secretary of 
Agriculture has delegated the responsibility for enforcing the AWA to 
the Administrator of the Animal and Plant Health Inspection Service 
(APHIS). Regulations established under the AWA are contained in 9 CFR 
parts 1, 2, and 3. The APHIS Animal Care program ensures compliance 
with the AWA regulations by conducting inspections of premises with 
regulated animals.
    APHIS is responsible for regulating the humane handling, care, 
treatment, and transportation of farm animals when they are used for 
nonagricultural purposes, such as for research or exhibition. APHIS 
inspects regulated entities that use farm animals under the regulations 
in 9 CFR part 3, subpart F.
    On March 3, 1999, we published a notice in the Federal Register (64 
FR 10268-10269, Docket No. 98-116-1) stating that we were considering 
adopting two guides: The ``Guide for the Care and Use of Agricultural 
Animals in Agricultural Research and Teaching'' (the Ag Guide), 
published by the Federation of Animal Science Societies, and the 
``Guide for the Care and Use of Laboratory Animals'' (the ILAR Guide), 
published by the Institute of Laboratory Animal Resources. We believed 
the guides would help regulated entities understand how to meet the 
standards in the regulations pertaining to the humane handling, care, 
treatment, and transportation of farm animals when they are used for 
nonagricultural purposes. We requested public comment on whether to 
adopt these two guides.
    We solicited comments for 60 days ending May 3, 1999. We received 
23 comments by that date. They were from veterinarians and veterinary 
associations, research facilities, animal welfare organizations, a 
biomedical research association, and a zoo and aquarium association.
    Several commenters supported our adoption of these two guides. 
Three commenters specified that our adoption of these guides would help 
maximize the similarities between AWA standards and the Public Health 
Service Policy on the Humane Care and Use of Laboratory Animals. 
Several commenters had questions about how regulated entities would be 
expected to use the guides, and other commenters had criticisms about 
the content of the guides. The comments are discussed below by topic.
    Several commenters wanted clarification on how APHIS would use the 
guides during inspections. One commenter asked if recommendations in 
the guides would become APHIS inspection standards that must be met. 
Another commenter asked how APHIS would decide which parts of the guide 
are to be followed and which are not.
    We stated in the March 3 notice that our adoption of these guides 
would be intended only as guidance and that it would not create or 
confer any rights for or on any person and would not operate to bind 
APHIS or the public. In practical terms, this means that these guides 
will not replace the regulations in subpart F as the standards that 
regulated entities are expected to meet. During inspections, APHIS 
inspectors will review the care of farm animals for compliance with the 
regulations in subpart F. We will not require regulated entities to 
comply with recommendations in the guides.
    However, we do believe that these guides represent the most current 
thinking on appropriate practices for the handling, care, treatment, 
and transportation of farm animals used for nonagricultural purposes. 
Because the regulations in subpart F are not species specific, we 
believe that would be helpful for regulated entities to consult 
guidance in order to adequately meet the regulations. For example, the 
regulations require that animals be fed a diet sufficient to maintain 
the animals in good health, consistent with the age, species, 
condition, size, and type of animal in question. We expect that 
regulated entities would find it helpful to consult some guidance to 
determine what diet would be appropriate for sheep, for example, in 
order to meet this requirement. By adopting the Ag Guide and the ILAR 
Guide, we are giving notice that we consider the recommendations in 
these two guides to be authorities on the care of farm animals as they 
relate to the requirements in the regulations. If a regulated entity is 
seeking guidance on meeting the regulations, we would suggest they 
start with these two guides. If regulated entities prefer, they may use 
other guidance, as long as the practices they ultimately adopt meet the 
requirements of the regulations.
    We stated in the March 3 notice that the ILAR Guide and the Ag 
Guide contain recommendations concerning

[[Page 5302]]

animals and areas that are not covered under the regulations and that 
those portions of the guides that do not relate to the regulations 
would not be used for our program purposes. For example, both guides 
contain recommendations on occupational safety and health programs for 
facility employees. Our regulations do not address these issues.
    One commenter asked whether APHIS would provide notice when the 
guides are revised and allow comments on adopting the revisions.
    Most recently, the guides have been updated approximately every 10 
years. The current ILAR Guide was published in 1996, replacing the 
previous 1985 edition. The current Ag Guide was published in 1999, 
replacing the previous 1988 edition. When these guides are updated, we 
will review the changes and make a determination at that time.
    We stated in the March 3 notice that the Ag Guide could be used 
when farm animals are maintained in a traditional agricultural setting 
and the ILAR Guide could be used when farm animals are maintained in a 
laboratory setting. One commenter said that, since the ILAR Guide does 
not specifically address farm animals, its adoption would result in no 
improvement for farm animals in laboratory settings. The commenter 
suggested that we adopt both guides for both agricultural and 
laboratory settings.
    The ILAR Guide is not species-specific, in general. However, it 
does state that its recommendations are applicable to farm animals, and 
it provides species-specific recommendations for farm animals in a few 
instances. In most cases, we believe that when farm animals are kept in 
a laboratory setting, the ILAR Guide is the appropriate guide to 
consult. The Ag Guide is written to address farm animals kept in 
agricultural settings. However, there may be elements of the Ag Guide 
that would be helpful to facilities that house farm animals in 
laboratories, and facilities could consult both guides.
    One commenter said that we should create our own guide on farm 
animals after review of the Ag Guide, the ILAR Guide, and other 
available guides. One commenter suggested two other guides that we 
should adopt. Several commenters said that we should promulgate 
standards specific to farm animals instead of adopting guidance.
    We considered these options prior to choosing to adopt the Ag Guide 
and the ILAR Guide. We have chosen to adopt guidance at this time, 
instead of promulgating regulations. We have determined that these 
guides represent the most current and complete scientific information 
available on the humane care of farm animals used for nonagricultural 
purposes, and we do not believe that creating our own guides would be 
an improvement over what these two guides already offer. Adoption of 
these guides does not prevent us from promulgating standards specific 
to farm animals at a later date.
    One commenter said that the Ag Guide and the ILAR Guide are dense 
documents, requiring significant time and effort to understand, and 
that students and nonscientist caretakers may find them difficult to 
apply for this reason. Another commenter said that some aspects of the 
Ag Guide are ambiguous, making them difficult to apply.
    We do not intend that every employee of a regulated facility must 
regularly consult these guides. Regulated entities may use these guides 
at their own discretion, depending on their needs and resources. We 
anticipate that many facilities already use or will choose to use these 
guides in formulating operating procedures for their facilities. In 
this case, the guides themselves may not need to be consulted in depth 
by students and nonscientist caretakers.
    In some sections, the Ag Guide uses language such as ``may'' and 
references other publications to support its statements. Understanding 
of the care and use of farm animals in research is constantly evolving. 
Nevertheless, we believe the Ag Guide presents the most complete and 
current information available.
    One commenter said that neither guide provides appropriate guidance 
for the care of farm animals used in exhibition. Another commenter, who 
supported adoption of the guides, said that flexibility would be 
necessary in their use to address the needs of traveling exhibitors.
    Both guides are specifically written as guidance for researchers. 
We believe elements of the Ag Guide, in particular, would also be 
useful for exhibitors. Even for traveling exhibitors, the Ag Guide 
offers recommendations on transportation of farm animals that we 
believe are appropriate. However, we recognize that exhibitors have 
special needs and different goals than researchers and would apply 
these guides only as appropriate.
    One commenter questioned our use of the term ``nonagricultural,'' 
and asserted that the application of biotechnology to traditional 
agricultural species does not automatically make the use of these 
animals nonagricultural.
    We are unclear as to how the commenter is defining 
``nonagricultural.'' Our use of the term stems from the definition of 
``animal'' in the AWA, which defines what animals we are authorized to 
regulate. The term ``animal'' means any live or dead warmblooded 
animal, but it excludes ``horses not used for research purposes and 
other farm animals, such as, but not limited to livestock or poultry, 
used or intended for use as food or fiber, or livestock or poultry used 
or intended for improving animal nutrition, breeding, management, or 
production efficiency, or for improving the quality of food or fiber.'' 
We consider use of an animal for food or fiber, for improving animal 
nutrition, breeding, management, or production efficiency, or for 
improving the quality of food or fiber to be agricultural, and we are 
not authorized to regulate these activities under the AWA.
    The commenter also suggested that animals kept in an agricultural 
setting should not be subject to APHIS oversight, regardless of use. 
However, the AWA authorizes APHIS to regulate animals used or intended 
for use in research, testing, experimentation, or exhibition purposes 
or as a pet, regardless of whether the animal is maintained in a 
laboratory setting or a typical farm-type setting.
    We received numerous comments critical of the Ag Guide in 
particular. Several commenters said that the Ag Guide is heavily 
influenced by standard agricultural commercial practices, endorses 
management practices designed for maximum agricultural production, and 
does not reflect the most current thinking on humane treatment of farm 
animals used for nonagricultural purposes. A few commenters further 
said that the Ag Guide would be unsuitable guidance for nonagricultural 
researchers because practices discussed in the guide would be stressful 
on the animals, resulting in unreliable research results.
    We disagree with the commenters and continue to believe that the Ag 
Guide represents the most current and complete scientific information 
available on appropriate practices for the handling, care, treatment, 
and transportation of farm animals used for nonagricultural purposes 
when they are maintained in an agricultural setting.
    One commenter said there are discrepancies between our regulations 
and the recommendations in the Ag Guide. For example, the commenter 
said Sec. 3.128 requires that enclosures provide sufficient space for 
each animal to make normal postural and social adjustments, but the Ag 
Guide includes recommendations on the use of farrowing crates for sows, 
which restrict the sows' movements.

[[Page 5303]]

    Adoption of the Ag Guide will not reduce any of the requirements in 
the current regulations, nor will any recommendations in the guide 
supersede the requirements of the regulations. Regarding the example 
given above, there may be times when it is scientifically justified 
under a research protocol to restrict an animal's space. Such 
exceptions to the regulatory requirements can be made with approval by 
a research facility's Institutional Animal Care and Use Committee. In 
other cases, regulated entities will be expected to comply with the 
requirements of the regulations, regardless of any recommendations in 
the Ag Guide or any other reference material.
    One commenter criticized the use of the phrase ``professional 
judgment'' throughout the Ag Guide and said the guide's use of the word 
``must'' is too limited.
    The Ag Guide is a guide, not a regulation. Our adoption of these 
guides is intended only to offer guidance to regulated entities.
    One commenter said the Ag Guide's recommendations on feeding and 
watering during transportation are inadequate.
    The regulations in Sec. 3.139 contain food and water requirements 
for farm animals during transportation. The regulations require that 
animals be offered potable water within 4 hours prior to being 
transported and that they be provided with potable water at least every 
12 hours after transportation is initiated. The regulations also 
require, with a few exceptions, that all animals be fed at least once 
in every 24-hour period. We find nothing in the Ag Guide in 
contradiction of these requirements. Nevertheless, the requirements of 
the regulations are the requirements that must be met by regulated 
entities, and nothing in the guide can be used to allow less stringent 
requirements than those in the regulations.
    Several commenters were concerned with the Ag Guide's acceptance of 
certain practices that may cause discomfort or some pain; for example, 
beak trimming, comb trimming, dehorning, and tail docking.
    The examples given by commenters are established standard animal 
husbandry practices. Employment of these practices is changing, and 
there is increased consideration among regulated entities regarding the 
use of local anesthetics and the development of methods that minimize 
discomfort for the animals. The Ag Guide encourages methods, including 
anesthesia and recommendations on optimum ages for these procedures, to 
minimize pain and discomfort in the animals.
    One commenter was concerned that the public was never given an 
opportunity to provide comments on the current edition of the Ag Guide 
prior to its being finalized.
    The Ag Guide is not published by APHIS and, therefore, we have no 
control over whether the public is able to comment on its content prior 
to it being finalized. We have, however, given the public opportunity 
to comment on our adoption of the content of the Ag Guide.
    In our notice, we said that any institution that receives funding 
from the National Institutes of Health (NIH) or that is accredited by 
an organization such as the Association for Assessment and 
Accreditation of Laboratory Animal Care International (AAALAC 
International) must use the Ag Guide and the ILAR Guide. One commenter 
said that this is incorrect. The commenter said that NIH and AAALAC 
International both mandate the use of the ILAR Guide, but that NIH does 
not mandate use of the Ag Guide, and AAALAC International uses the Ag 
Guide selectively.
    The commenter is correct in pointing out that the Ag Guide is cited 
as a resource by both organizations, but its use is not mandated as a 
requirement for receiving funding. We wish to correct our inadvertent 
misstatement. We should note that AAALAC International referenced the 
previous version of the Ag Guide only selectively, but has adopted the 
revised (1999) version of the Ag Guide as a reference in its entirety.
    One commenter said that APHIS should inspect AAALAC International-
accredited research facilities between AAALAC International inspections 
in order to reduce the inspection frequency for such facilities. The 
commenter said the facilities could assure APHIS annually that they 
remain fully accredited and submit the date of the last AAALAC 
International inspection.
    This comment is not relevant to the adoption of the ILAR Guide and 
the Ag Guide. Nevertheless, we offer the following response. AAALAC 
International conducts site visits of accredited facilities at 
approximately 3-year intervals. The AWA mandates that we inspect 
research facilities at least once each year. APHIS' inspections are 
unannounced to ensure we are able to view the facility as it is 
normally operated. At this time, we believe any effort to coordinate 
our inspections with the inspections of another institution may 
compromise our ability to conduct inspections unannounced.
    Based on the rationale given in the March 3 notice and in this 
document, we are adopting the Ag Guide and the ILAR Guide to assist 
regulated entities in meeting the standards in the regulations as they 
apply to the handling, care, treatment, and transportation of farm 
animals used for nonagricultural purposes.

    Done in Washington, DC, this 27th day of January 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-2382 Filed 2-2-00; 8:45 am]
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