Animal Welfare; Farm Animals Used for Nonagricultural Purposes

From: GPO_OnLine_USDA
Date: 2000/02/03


[Federal Register: February 3, 2000 (Volume 65, Number 23)]
[Notices]
[Page 5301-5303]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe00-34]

------------------------------------------------------------------------

[[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.

-----------------------------------------------------------------------

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]
BILLING CODE 3410-34-U



This archive was generated by hypermail 2b29 : 2000/05/19 EST