HUMANE HANDLING, CARE, TREATMENT, AND TRANSPORTATION
OF DOGS AND CATS, AND NONHUMAN PRIMATES
[NOTE: See section 3.81 for information concerning the promotion
and psychological well-being of nonhuman primates.]
02/15/91 Vol. 56, No. 32, Federal Register, Pages 6426-6505
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 3
[Docket No. 90-218]
RIN: 0579-AA20
Animal Welfare; Standards
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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------------ SUMMARY: We are amending the regulations for the
humane handling, care, treatment, and transportation of dogs and
cats, and nonhuman primates, by a comprehensive revision and
rewriting of those regulations. The effect of this action is to
update the regulations, to make them more consistent with other
Federal regulations concerning the handling, care, treatment, and
transportation of these animals, and to carry out the requirements
of the amendments to the Animal Welfare Act (7 U.S.C. 2131, et
seq.), enacted December 23, 1985. Rewriting the regulations also
makes them easier to understand, thereby increasing compliance and
making them more effective.
EFFECTIVE DATE: This final rule shall become effective March 18,
1991. Plans for providing exercise of dogs in Sec. 3.8 and for
promoting the psychological well-being of nonhuman primates in Sec.
3.81 must be implemented by August 14, 1991.
FOR FURTHER INFORMATION CONTACT: Dr. R. L. Crawford, Director,
Animal Care Staff, Regulatory Enforcement and Animal Care, APHIS,
USDA, room 565, Federal Building, 6505 Belcrest Road, Hyattsville,
MD 20782, (301) 436-7833.
SUPPLEMENTARY INFORMATION:
Background
This final rule revises the regulations contained in 9 CFR, part
3, subparts A and D. It is the result of an intensive effort that
began in 1985 when Congress amended the Animal Welfare Act (7
U.S.C. et seq.) (the Act) in Public Law 99-198, "The Food Security
Act of 1985," and directed the Secretary of Agriculture to
promulgate certain new relations governing the humane handling,
care, treatment, and transportation of animals by dealers, research
facilities, and exhibitors, including requirements for exercise of
dogs and a physical environment adequate to promote the
psychological well- being of nonhuman primates. The final rule
reflects the many years of experience of the Animal and Plant
Health Inspection Service (APHIS), United States Department of
Agriculture (the Department) in enforcing the Act and the Animal
Welfare regulations (the regulations). We considered many thousands
of public comments in deciding upon the content of the final rule.
Our ongoing consultation with the United States Department of
Health and Human Services (HHS), as well as other Federal agencies
concerned with animal welfare, also contributed significantly to
determining how best to fulfill our statutory mandate.
Due to the length and complexity of this document, it is broken
down into general headings and specific subheadings where
appropriate, to assist the reader. The supplementary information
begins with a brief history of this rulemaking. Following that are
our response to the comments we received regarding our August 15,
1990, revised proposal, and the changes we are making based on
those comments and our ongoing consultation with HHS. Lastly, we
address the concerns raised in the public comment letters regarding
our economic assessments of the cost of implementing the proposed
regulations.
General Background and Statutory Information
The regulations are contained in title 9 of the Code of Federal
Regulations, chapter I, subchapter A, parts 1, 2, and 3. Part I
provides definitions of the terms used in parts 2 and 3. Part 2
sets forth the administrative and institutional responsibilities of
regulated persons under the Act. Part 3 provides specifications for
the humane handling, care, treatment, and transportation, by
regulated entities, of animals covered by the Act. Subpart A of
part 3 contains the regulations concerning dogs and cats; subpart
B contains the regulations concerning guinea pigs and hamsters;
subpart C contains the regulations concerning rabbits; subpart D
contains the regulations concerning nonhuman primates; subpart E
contains the regulations concerning marine mammals; and subpart F
contains the regulations concerning other warmblooded animals
regulated under the Act. APHIS issues and enforces the regulations,
under authority of the Act, as amended.
On December 23, 1985, extensive amendments to the Act were
enacted (see Pub. L. 99-198, "The Food Security Act of 1985.").
Among other things, the Act directs the Secretary of Agriculture to
promulgate standards to govern the humane handling, care,
treatment, and transportation of animals by dealers, research
facilities, and exhibitors, for exercise of dogs, and for a
physical environment adequate to promote the psychological well-
being of nonhuman primates. In order to comply with the amendments
to the Act, APHIS published revisions of parts 1 and 2, and a
proposal and a revised proposal to amend part 3, as discussed
below.
Proposals to amend parts 1 and 2 of the regulations were
published in the Federal Register on March 31, 1987 (52 FR
10292-10298, Docket No. 84-027, and 52 FR 10298-10322, Docket No.
84-010, respectively). We solicited comments for a 60-day period,
ending June 1, 1987. The comment period was twice extended, ending
on August 27, 1987. We received 7,856 comments, many of which
stated that it was difficult to comment upon the proposals to amend
parts 1 and 2 independently of our proposal to amend the standards
in part 3. In response to comments, we published revised proposals
on parts 1 and 2, along with a proposed rule to amend subparts A,
B, C, and D of part 3, on March 15, 1989 (54 FR 10822-10835, Docket
No. 88-013; 54 FR 10835-10897, Docket No. 88-014; and 54 FR
10897-10954, Docket No. 87-004, respectively).
We solicited comments on the interrelationship of parts 1 and 2
with part 3 for a 60-day period, ending May 15, 1989. Approximately
5,600 comments, received or postmarked by that date, were
considered in preparing final rules for parts 1 and 2. (Any that
also pertained to part 3 were considered as responding to the
proposal to amend part 3.) The final rules to amend parts 1 and 2
were published in the Federal Register on August 31, 1989 (54 FR
36112- 36123, Docket No. 89-130, and 54 FR 36123-36163, Docket No.
89-131, respectively).
Most of our proposal with regard to part 3 dealt with revisions
to the standards, based on our experience enforcing the
regulations. We also proposed certain significant additions to the
regulations, based on our mandate under the 1985 amendments to the
Act. For example, we made significant additions to the regulations
regarding the exercise of dogs and regarding a physical environment
necessary to promote the psychological well- being of nonhuman
primates. We solicited comments on the proposal to amend part 3 to
be made for a 120-day period, ending July 13, 1989. A total of
10,686 comments were received in time to be considered. Included
among the recommendations we received in response to the proposed
rule were those submitted by HHS, with whom we continued our
ongoing consultation. Of the total number of comments received, the
overwhelming majority were in response to our proposed changes
regarding subparts A and D.
Upon review of the comments regarding subparts B and C, we
determined that, in general, our proposed revisions of those
subparts were appropriate, with some minor modifications. On July
16, 1990, we published a document making final the proposed
amendments to part 3 that pertain to subparts B and C (55 FR
28879-28884, Docket No. 89-175). However, due to the nature of the
comments received in response to our proposed amendments regarding
subparts A and D, and as a result of our ongoing consultations with
other Federal agencies, we made certain major modifications to our
March 15, 1989, proposal, and issued a revised proposal regarding
those subparts on August 15, 1990 (55 FR 33448-33531, Docket No.
90-040).
We received a total of 11,932 comments in response to our revised
proposal in time to be considered. Of the comments received, 509
were from dealers and exhibitors, 1,372 were from the research
community, and 10,051 were from members of the general public. We
included comments received from humane societies and groups
representing the public in the areas of animal welfare and animal
rights with comments from the general public.
Comments raising objections or suggesting changes to the revised
proposal are discussed below in this supplementary information.
Subheadings are provided in the supplementary information to guide
the reader through the material. Section numbers are used in the
subheadings wherever possible to further assist the reader. We have
made a number of changes to our August 15, 1990, proposal in this
final rule. Those changes are explained in the supplementary
information below. The remaining provisions of our proposal are
necessary to ensure the health and well-being of the animals in
question, and we have included these remaining provisions in this
final rule, except to make certain nonsubstantive wording changes
for clarification.
In our discussion of the comments received, we use the term
"proposed" or "proposal" when referring to the August 15, 1990,
revised proposal. We use the term "original proposal" when
referring to the March 15, 1989 proposal. When referring to the
regulations in 9 CFR part 3 prior to the effective date of this
final rule, we refer to the "existing regulations."
General Comments
A large number of commenters expressed general support for the
proposed provisions, and for more stringent regulations in general.
A large number of commenters supported the proposed provisions that
would establish requirements for increased space for animals. Many
commenters also supported exercise for laboratory animals. A small
number of commenters supported those provisions that they said
would not interfere with research.
Conversely, very many commenters opposed the proposal in
general. Many of these stated in general that the provisions that
represented revisions to our March 15, 1989 proposal were
unacceptable. A number of commenters stated generally that the
proposal should be rewritten. A number of commenters expressed
opposition to more stringent regulations. Many commenters
recommended that no changes be made to the existing regulations. A
number of commenters asserted that the proposed regulations go
beyond ensuring the humane care and use of animals. Some of these
commenters stated that the proposed standards exceed statutory
authority and are inconsistent with Congressional intent. In this
final rule, APHIS's statutory authority for the proposed regulatory
amendments is set forth in the supplementary information, under the
headings "General Background and Statutory Information" and
"Statutory Authority for This Final Rule." Based on the statutory
authority set forth, we believe ample authority exists for this
rule.
A large number of commenters stated that the involvement of
other Federal agencies in the rulemaking process is resulting in
weaker animal welfare regulations. We do not agree that the
regulations are being weakened. On the contrary, this final rule
contains a significant number of provisions that are more stringent
than those in the existing regulations. Additionally, two
significant areas in the proposal--the exercise of dogs and the
psychological well-being of nonhuman primates--are not in the
existing regulations.
A number of commenters opposed in general what they considered
the weakening of our original proposal in the revised proposal. We
do not agree that the revised proposal represents a weakening of
our original proposal. We gauge the strength of the animal welfare
regulations by how well they effectuate the humane handling, care,
treatment, and transportation of the animals in question. Our goal
is to accomplish this end in the most reasonable and efficient way
possible. We expect the provisions in this revised rule to attain
the same ultimate goal as those in the proposed rule.
Many commenters stated that they favored more specific, rather
than general standards. Of those favoring more specific standards,
many expressed opposition to "performance standards," as contrasted
with "engineering standards." Conversely, very many commenters
stated that they were in favor of replacing engineering standards
with performance standards. A small number of commenters asserted
that including rigid engineering standards in the proposed
regulations was contrary to the directives of Executive Order No.
12498. Many commenters stated that the proposed standards would
interfere with research due to their rigidity and specificity, and
would not allow the flexibility and innovations necessary for the
optimal care and treatment of animals. Many commenters stated that
rigid engineering standards are not suitable for regulating a wide
range of facilities, interfere with professional judgment, rapidly
become obsolete, and are not scientifically justified. In
developing the proposed rule, we relied on our experience enforcing
the regulations, on our scientific expertise, on information
supplied by other Federal agencies, on research data regarding
animal behavior, and on other information submitted by the public.
Our goal was to establish regulations that would both promote the
well-being of the animals in question and be enforceable. We did
not consider it appropriate to couch all the proposed regulations
either in the form of performance standards or engineering
standards. In formulating the proposal, we attempted to identify
those areas where variations in circumstances and animal behavior
would make very specific standards less effective in promoting
animal welfare than broader, goal-oriented standards. In those
areas, we proposed to allow for flexibility in how the goal would
be reached. In other areas, we determined that the needs of most of
the animals housed, handled, or transported together were so
similar that specific uniform standards were more appropriate, both
for enforceability and for the well-being of the animals. Even in
those areas, however, we recognized that in some cases the same
specific requirements would not be appropriate for every animal
involved. To accommodate these exceptions, we provided in many
cases for professional discretion by the attending veterinarian. We
believe that the provisions in this final rule represent a
practical and enforceable blend of performance and engineering
standards.
Many commenters stated that Congressional intent regarding the
Act was for APHIS to avoid the use of performance standards. These
commenters referred to correspondence between certain members of
Congress and the United States Office of Management and Budget, in
which the members of Congress urged that specific standards be
adopted. We are aware of the correspondence referred to, and do not
agree that it fully represents Congressional intent. On the
contrary, the Congressional Conference Report on the Fiscal Year
1991 Agricultural Appropriations Bill contains the following
language: "The conferees expect the Animal and Plant Health
Inspection Service to incorporate performance based standards into
its regulations when such performance based standards would not
interfere with the establishment of a minimal level of care or the
enforceability of the Act as Congress intended." As discussed
above, we have therefore incorporated performance based standards
where we considered them appropriate.
A number of commenters stated that researchers do not have the
expertise to assess performance standards. We do not share the
commenters' concern. The standards set forth in the proposal
clearly state the ends that must be achieved. The regulated
facilities, and not any particular researchers, is responsible for
achieving these ends. We are confident each facility has or has
access to the professional expertise adequate to ensure compliance
with the regulations.
One commenter stated that the National Institutes of Health (NIH)
Guide for the Care and Use of Laboratory Animals (Guide) must not
be used as a minimum regulatory standard. Several commenters stated
that it is not scientifically valid to adopt as Federal regulations
all of the elements currently proposed to be adopted from the NIH
Guide. Conversely, a large number of commenters stated that they
concurred with coordination between certain provisions of the
regulations and the NIH Guide. Section 15(a) of the Act requires
that the Secretary of Agriculture consult and cooperate with other
Federal agencies in establishing standards, and consult with the
Secretary of HHS before issuing regulations (7 U.S.C. 2145(a)).
However, notwithstanding our obligation to consult, we are mindful
that Congress has entrusted the Department with the responsibility
for establishing minimum requirements to carry out the Act's
purposes, and for administering the Act because of our expertise in
animal welfare matters. In the entire proposal, several areas
contained provisions that paralleled those in the NIH Guide. In
those cases, in fulfilling our responsibility to set forth
regulations providing for animal welfare, we were also able to set
forth regulations that harmonized with the NIH Guide.
One commenter stated that the proposed rulemaking would
radically alter established Public Health Service/NIH policies. We
disagree. The Public Health Service issues their Guidelines
independent of our statutory mandate. This rule concerns the
implementation of the Animal Welfare Act, for which the Secretary
of Agriculture is responsible. In developing the proposed rule, we
carried out our statutory obligation to consult with HHS. The
consultations we conducted with that Department were comprehensive
and intensive. A representative from the National Institutes of
Health worked closely with APHIS to provide the HHS position on all
issues affecting the research community. Through this consultation,
we achieved what we understand to be a mutually satisfactory
document. Based on our ongoing communication with HHS, that it can
be readily implemented by the research community.
A number of commenters stated that the proposal was not
stringent enough to meet the intent of Congress. We disagree. The
intent of Congress was to provide for the enhanced well-being of
the animals covered under the Act, and in particular to provide for
the exercise needs of dogs and to promote the psychological well-
being of nonhuman primates. Congress has provided the Department
the authority to develop regulations to promote animal welfare. We
believe the standards in this final rule provide the flexibility to
accommodate varying conditions and procedures, while still
providing the opportunity for exercise of dogs and an environment
to promote the psychological well-being of nonhuman primates. In
certain cases, based on information supplied by the public, we have
made modifications to our proposal to promote better the well-being
of the animals covered by the Act and the regulations.
A number of commenters stated that the proposed regulations are
not supported by scientific documentation, that they are arbitrary
and capricious, and that they provide no evidence either that the
existing standards are inadequate or that the proposed standards
will be of benefit to the animals' welfare. A number of commenters
recommended that the proposal be rewritten to reflect available
scientific information and current professional consensus. A
smaller number of commenters expressed the opinion that APHIS does
not have the technical competence to promulgate the proposed
standards. The proposal we published was the result of a
Congressional mandate to establish standards to provide for the
exercise of dogs and for the psychological well-being of nonhuman
primates, as well as the result of changes to the regulations that
we considered appropriate based on over 20 years of enforcing those
regulations. As noted above, in 1989 we published an initial
proposal to amend and expand the regulations. We invited public
comment on that proposal, soliciting whatever scientific data was
available. Based on the information we received, and on our ongoing
consultation with other Federal agencies, we made a number of
significant modifications to that initial proposal. The basis for
these changes was discussed in the preamble of the revised proposal
that we published August 15, 1990. In that revised proposal, we
again invited research data and other public comment. We have
carefully reviewed all of the data and other information submitted
to us, and, based on that information, have made certain
modifications in this final rule. The basis for these modifications
is discussed in the supplementary information of this final rule.
A small number of commenters recommended that separate standards
be established for research, dealer, and exhibitor facilities. As
we discussed in our proposal, while provisions do exist in the
regulations to ensure that the standards in part 3 do not interfere
with approved research, in general we do not believe that separate
standards for different types of facilities are appropriate. The
Act requires that we establish minimum standards for the humane
care and well-being of animals. The fact that the standards we
proposed are minimum assures that they will be adequate for each
type of facility.
A large number of commenters stated in general that the
scientific community is highly motivated to maintain the best
possible laboratory animal care, because it is essential for humane
reasons and to ensure productivity and accuracy. As discussed in
the proposal, we agree that humane treatment of animals used in
research promotes the well-being of the animals and the research
value of the activities conducted. The standards set forth in part
3 of the regulations are minimum standards necessary for the well-
being of animals housed, held, or maintained at any of the various
categories of regulated entities. We encourage and applaud
treatment of animals according to standards in excess of the
minimum. However, as discussed above, we do not consider it
appropriate or warranted to establish a separate set of standards
for each type of regulated entity, as was suggested by these
commenters.
Many commenters stated that the proposed regulations contain too
many "loopholes" that allow facilities to interpret or circumvent
standards, even though this is what Congress intended to avoid with
its 1985 amendments to the Act. A small number of commenters stated
that APHIS should not allow any exemptions from the regulations,
even if approved by the Institutional Animal Care and Use Committee
(Committee) at research facilities. We disagree. Throughout this
rulemaking process, we have remained cognizant that section
13(a)(6) of the Act prohibits the Secretary from interfering with
research design or the performance of actual research. Accordingly,
the regulations provide research facilities with exceptions from
the standards in part 3, when such exceptions are specified and
justified in the proposal to conduct the activity. This provision
is clearly set forth in part 2 of the regulations, and we do not
agree, as one commenter recommended, that a similar provision is
necessary as preface to part 3.
On the other hand, a number of commenters stated that APHIS
exceeded statutory authority and Congressional intent by proposing
regulations that interfere with research facilities' right to
determine whether an activity is to be considered as a part of the
performance of research. We disagree. These regulations are
consistent with the Act's requirement that our regulations do not
interfere with the design or performance of research. One
commenter asked that we clarify which provisions could be departed
from if approved in a research protocol, and which need to be
adhered to in every case. The Act is clear on this issue. No
provision in the regulations is to interfere with research that is
part of an approved protocol.
A large number of commenters addressed the issue of primary
enclosure size. Of those discussing primary enclosures, many
supported the areas where our proposed provisions coincided with
the NIH Guide. Very many commenters supported in general larger
cages for animals. Many commenters stated that the minimum space
requirements set forth in the proposal were insufficient. Based
both on our experience enforcing the regulations and on animal
research, we disagree that the minimum space requirements we
proposed are insufficient. In the case of each of the animals whose
treatment is regulated under subparts A and D--cats, dogs, and
nonhuman primates--the specific minimum space requirements are at
least as stringent as those in the existing regulations. In the
case of cats, we have increased the space requirements from the
existing regulations. In the case of dogs, we have maintained the
existing floor space requirements for most dogs, have increased the
space requirements for certain dogs, and have added height
requirements. In the case of nonhuman primates, we have set forth
space requirements that in effect closely parallel those in the
existing regulations, and that in certain cases exceed the
requirements in the existing regulations. In all cases,
notwithstanding the specific primary enclosure dimensions required
by the proposal, the regulations would require that the animal be
able to move in a normal manner.
Several commenters stated generally that the proposed regulations
would unduly restrict the exercise of professional judgment by the
attending veterinarian and other laboratory animal professionals.
We recognize that under certain circumstances, specific uniform
requirements will not be most effective in promoting the well-being
of all animals involved. To accommodate such situations, we have,
in many cases, provided for discretion on the part of the attending
veterinarian. We therefore disagree with the commenters that the
provisions of this final rule will unduly restrict professional
judgment.
Many commenters stated generally that the proposed regulations
would have an adverse effect on animal welfare. We disagree. The
regulations set forth in this final rule include the addition of
certain requirements for the well-being of animals, as mandated by
Congress, and amendments to the existing regulations that we
consider necessary to improve animal care. We consider this final
rule to be an improvement over the existing regulations.
A large number of commenters expressed concern that the proposed
regulations would be unenforceable, given the current number of
inspectors employed by the Department. We are making no changes
based on these comments. In developing the proposed regulations, we
were cognizant of the demands they would make on Department
personnel, and are confident that the proposed provisions are
workable and enforceable. Beyond that, we believe that they are
necessary to enable us to meet our Congressional mandate to promote
and protect the well-being of the animals covered under the Act.
Many commenters stated more specifically that the Department would
have difficulty enforcing the provisions regarding exercise
requirements for dogs and the promotion of the psychological well-
being of nonhuman primates. We disagree. Those particular areas of
the regulations require facilities to develop plans for meeting the
respective needs of dogs and/or nonhuman primates. In enforcing the
regulations, an inspector will visually inspect the animals and the
facility, and will review the required plans, as well as records of
any exemptions for specific animals, to verify what he or she
observes. Development of the plans will require involvement of the
attending veterinarian, and in the case of research facilities, the
Committee. We are confident that such professional involvement,
combined with inspections by the Department, will be of greater
benefit to the animals involved than rigid, across-the-board
standards that do not take into account varying conditions and
procedures.
One commenter stated that the attending veterinarian should have
greater discretion in the formulation of animal care plans, and
that all veterinarians should be board-certified. The regulations
require that the attending veterinarian have knowledge of the
species to be maintained at a facility. Additional requirements
would be at the discretion of the facility.
One commenter stated that the regulations as proposed allow for
too much "professional judgment" on the part of the attending
veterinarian. The commenters questioned whether all veterinarians
would have the integrity necessary to make sound professional
judgments. Under the regulations, the attending veterinarian is
responsible to the facility, which is responsible for compliance
with the regulations. The facility is therefore dependent on the
attending veterinarian's sound judgment to remain in compliance.
Additionally, all decisions made by attending veterinarians will be
subject to review by APHIS inspectors.
A large number of commenters stated that requirements for
exercise of dogs and social interaction of primates must be spelled
out clearly. We consider the requirements referred to be set forth
clearly in our proposal. It is clear what ends are to be achieved.
However, we do not consider it in the best interests of individual
animals, many with differing needs, to restrict all facilities to
the same specific set of procedures in achieving those ends.
In certain provisions in the regulations, the standards allow for
adherence to "generally accepted practices." A small number of
commenters stated that this term is vague, and that inspectors will
be unable to evaluate whether a facility is in compliance. We
disagree. Department inspectors are professional veterinary medical
officers or animal health technicians, and are well trained in, and
able to evaluate what constitute, generally accepted practices. A
number of commenters stated that customary and generally accepted
practices were precisely what Congress was objecting to when it
required that the regulations be amended. We disagree with the
general statement that generally accepted practices are harmful to
animals. We particularly disagree with the allegation that accepted
professional veterinary practices are inadequate. Even in the
absence of Federal regulations regarding animal care, the
veterinary profession adheres to its own professional standards to
ensure the well-being of the animals it attends to. The changes
that Congress mandated in the 1985 amendments to the Act were for
the most part additions, not amendments, to the existing
regulations. These additions, specifically relating to exercise for
dogs and the psychological well-being of non-human primates, have
been included in the regulations in such a way as to allow for the
diversity of needs among species, breeds, individual animals, and
conditions. A more rigid, inflexible approach could actually prove
injurious to the animals.
A large number of commenters stated that facilities need to be
able to establish their own performance standards, so that a
facility can ensure adequate animal care and can accommodate
special institutional needs and circumstances. Conversely, a number
of commenters stated that the Department is illegally delegating
its statutory duty to issue regulations to those being regulated.
We disagree that the Department is inappropriately delegating its
authority. Through the regulations set forth in this final rule, we
are establishing standards for the exercise of dogs and the
psychological well-being of nonhuman primates. Under the
regulations, facilities are authorized only to develop specific
procedures for meeting the standards.
One commenter stated that any plans or standard operating
procedures developed by a Committee to comply with the regulations
should be required to be submitted for Department approval. Under
the regulations, such plans will be subject to review by Department
inspectors. We therefore do not consider it necessary to require
their submission for approval prior to implementation.
The regulations as proposed provided in certain cases for written
documentation by facilities of procedures and exemptions. A number
of commenters questioned whether APHIS would retain copies of this
documentation. The commenters expressed concern that if APHIS took
possession of copies, that information would then be available to
the public under the Freedom of Information Act. According to the
commenters, this would both allow competitors access to information
associated with research, and provide potential terrorists with
information regarding facilities. As a general rule, the written
documentation required by the regulations will be inspected by
APHIS at the facility, and will not be copied or removed. However,
APHIS will have the option of removing such documentation if
removal is necessary to carry out enforcement procedures.
One commenter recommended that the general public and any
veterinarian be permitted access to records of research facilities
to assist APHlS in monitoring these sites for compliance. Under the
Act, enforcement is restricted to Department employees, and may not
be delegated to members of the public.
A number of commenters stated that the proposed regulations would
burden research facilities with unnecessary paperwork. On the other
hand, a large number of other commenters opposed the elimination in
the revised proposal of any recordkeeping requirements that
appeared in the original proposal. One commenter called for daily
or weekly documentation by facilities of compliance with the
regulations. A number of other commenters stated that the proposed
standards for laboratory animals were carefully drawn to avoid
unnecessary paperwork. Under the Paperwork Reduction Act, we are
required to minimize the paperwork burden on the public, consistent
with the proper performance of our responsibilities under the Act.
Cognizant of this obligation, we developed the proposed regulations
with the goal of reducing paperwork requirements as much as
possible, while still retaining the ability to document adequately
conditions for enforcement purposes. Eliminating documentation
requirements entirely would in certain areas hinder our ability to
carry out our mandate to promote and enforce the welfare of animals
covered under the Act. The recordkeeping and reporting requirements
in this final rule represent what we consider the minimum necessary
to enable us to enforce the regulations adequately.
Some commenters stated that the proposed regulations would
eliminate the transport of animals by air. However, the commenters
did not supply data to support these assertions. The purpose of
amending the regulations is to help ensure the health and well-
being of dogs and cats. In the absence of data indicating that
other factors should override specific measures proposed to achieve
this goal, we are making no changes to our proposal based on these
comments.
A small number of commenters stated that the regulations should
differentiate clearly between standards for transportation of
shipped animals, and those traveling with passengers. With regard
to carriers and intermediate handlers, the regulations specify that
animals are covered by the regulations when "accepted" by those
entities for transport. If these animals are in the possession of
individuals in passenger areas, they are not subject to the
regulations. Several commenters stated that the transportation
standards should be clarified as to "transport in commerce" and
"transport between buildings." We do not consider such a
distinction necessary. Regulated animals must be handled in
compliance with the standards at all times.
Several commenters stated generally that the proposed standards
would result in an increased risk of disease and injury to both
humans and animals. We believe that the proposed regulations should
pose little increased risk if proper medical, health, husbandry,
and safety procedures are followed. Whatever risk might exist will
be minimized by the provisions in this final rule that allow for
professional judgment as to the health and safety needs of
individual animals, breeds, and species.
A small number of commenters stated that standards for
temperature ranges should be as uniform as possible throughout the
regulations to avoid confusion. In many areas in this final rule,
based on information we received from the public, we have made
changes to standardize allowable temperature ranges. These changes
are discussed in the supplementary information of this final rule.
One commenter recommended that all temperature and humidity
standards be deleted from the regulations, and be replaced with
general performance standards. We disagree with the commenter with
regard to temperature requirements. Although the needs and
tolerances of individual animals allow for some variation in
acceptable temperature levels, certain upper and lower limits exist
that are applicable to animals in general. With regard to humidity,
the regulations as proposed already provide for professional
discretion in determining appropriate humidity levels.
A number of commenters stated that environmental and temperature
standards for animals should be similar to human standards until
comfort indices for various species can be established. We disagree
with the commenters. Differences among species do not allow for
accurate cross-species comparisons.
One commenter stated that allowing for flexibility or innovation,
as provided in certain cases in the regulations, is inappropriate
when dealing with minimum standards. We disagree. The regulations
include minimum standards, as required by law. In allowing for
flexibility and innovation, we are simply allowing regulated
entities some latitude in determining how to satisfy those minimum
requirements.
One commenter stated that the regulations would create an
adversarial relationship between veterinarians and researchers.
Several commenters stated that under the proposed regulations, the
attending veterinarian and Committee would become an enforcement
agent of APHIS, which is not authorized by the Act. One commenter
opposed the involvement of the Committee in the approval of
procedures, because, according to the commenter, this usurps
management's role and exceeds APHIS's statutory authority. Under
the regulations, the research facility is responsible for ensuring
that the regulations are met. Under the regulations, the attending
veterinarian and the Committee are to provide professional judgment
to the facility. We do not consider this an adversarial
relationship, nor do we consider it as delegating enforcement
authority to either the attending veterinarian or the Committee.
A small number of commenters stated that many of the proposed
provisions would be used to eliminate animals from biomedical
research. As we discussed in our proposal, history does not support
such an assertion. Concerns regarding the elimination of animals
from research were raised in 1966 and 1967 when the Act was first
enacted and regulations were promulgated to implement it. To the
contrary, however, tremendous advances in human and animal health
have been made possible through continued support for biomedical
research. In enacting the 1985 amendments to the Act, Congress
specifically found that the use of animals is instrumental in
certain research and education (7 U.S.C. 2131(b)). We believe that
the provisions of this rule will effectuate the intent of Congress
without imposing an unnecessary, unreasonable, or unjustified
financial burden.
Several commenters expressed concern that the proposed
regulations would discourage young people from entering medical
research fields. We disagree. We believe that greater concern for
the humane care and use of animals may in fact encourage new
scientists and foster greater support for biomedical research
throughout our society.
One commenter stated that the phrasing of the proposed
regulations indicated application to non-animal areas. In certain
cases, such as housekeeping standards, application to non-animal
areas was intentional, because the condition of a premises can have
an impact on the animals housed at the facility. In certain other
cases, such as temperature requirements in housing facilities,
qualifying language is included to make it clear that the standards
need be met only when animals are present. We believe that the
remainder of the proposed provisions express their intent clearly
as to which areas of a facility, conveyance, or operation would be
affected.
Several commenters recommended that the proposed regulations
include an index to allow easier retrieval of information. We do
not believe it is necessary to include an index in the regulations.
Each of the subparts designates the types of animals it covers.
Within each subpart, the contents of each section are indicated by
a section heading. These headings are set forth in a table of
contents at the beginning of each subpart. We believe that this
format provides adequate reference to the contents of the
regulations.
Several commenters requested that, in developing a final rule,
the Department consider all comments received on previous proposed
standards, as well as those received on our most recent proposal.
We take seriously our responsibility under the Administrative
Procedure Act to consider each comment timely received in response
to proposed rulemaking. Accordingly, we have reviewed all such
comments in the process of developing and modifying the rulemaking
that is culminating in this final rule.
One commenter stated that all pet animal businesses should be
covered by the regulations. The regulations in subparts A and D
apply to those entities specified under the Act as being subject to
its provisions. Under the Act, certain retail stores that sell pet
animals are subject to the Act and the regulations. Other
commenters stated that humane societies, animals rights
organizations, and other special interest groups should be subject
to the regulations. Such entities are not specified under the Act
as being subject to its provisions, and therefore are not subject
to the regulations unless they also act as dealers, exhibitors,
research facilities, intermediate handlers, or carriers.
Several commenters stated either that the proposed regulations
were written in a manner not understandable by the general public,
thereby making comments on them difficult, if not impossible, or
that the regulations should be reformatted or rewritten to improve
their clarity. Based on the great number of comments we received
addressing both specific and general provisions set forth in the
proposal, we believe that in general the public found the proposed
provisions understandable.
Effective Dates
A large number of commenters addressed the issue of when the
regulations should become effective. Several commenters expressed
the opinion that the Department is obligated to make the amended
regulations effective upon publication of this final rule. One
commenter stated that the Department has already exceeded the time
during which it was legally obligated to establish new regulations.
Many more commenters called for a delay in the effective date, in
order to allow time for adequate planning and financing. The
commenters requesting a delay recommended that the regulations,
particularly those provisions regarding minimum space requirements,
become effective from 1 to 5 years after publication. A small
number of commenters requested that primary enclosure space
requirements be "grandfathered" in, to allow use of existing
primary enclosures that are not in compliance with the new
standards, until those enclosures would otherwise need replacement.
We disagree that the Department has illegally delayed
publication of this final rule. On the contrary, the Department has
diligently pursued the promulgation of these regulations with as
much speed as their complexity allows. We are keenly aware of the
economic impact these amended regulations will have on regulated
entities. However, we are obligated to establish standards to
promote the well-being of the animals protected by the Act,
notwithstanding the fact that expenses will be incurred by
regulated facilities in complying with the regulations. We are also
aware of our obligation under Executive Order 12291 to minimize the
economic impact of these rules on affected entities. In recognition
of this responsibility, and of the practical delays that will
necessarily be associated with complying with certain of the new
requirements, we are providing that the facility plans for
providing exercise of dogs, and for promoting the psychological
well-being of nonhuman primates, must be developed and implemented
within 180 days of the publication date of this final rule.
Many commenters pointed out that several of the new requirements
would require affected facilities to make extensive structurally
related changes in order to be able to comply with the new
regulations. We believe those comments are well-founded and,
therefore, in order to allow affected facilities the time necessary
to make such changes, we are providing in this rule that regulated
persons have until February 15, 1994, to comply with a few,
specific provisions. These provisions appear in this rule in the
following places:
1. Section 3.6(b)(1)(ii)(A) through Sec. 3.6(b)(1)(ii)(C)
(redesignated from Sec. 3.6(b)(1)(i) through Sec. 3.6(b)(1)(iii) in
the proposed rule), regarding minimum space requirements for
primary enclosures containing cats;
2. Section 3.6(c)(1)(iii), regarding height requirements for
primary enclosures containing dogs;
3. Section 3.6(c)(2)(ii) (redesignated from Sec. 3.6(c)(2) in the
proposed rule), regarding perimeter fences surrounding dogs kept on
tethers;
4. Section 3.77(f), regarding perimeter fences surrounding
nonhuman primates housed at sheltered housing facilities;
5. Section 3.78(d), regarding perimeter fences surrounding
nonhuman primates housed at outdoor housing facilities; and
6. Section 3.80(b)(2)(i) through Sec. 3.80(b)(2)(iv)
(redesignated from Sec. 3.80(b)(1), Sec. 3.80(b)(2), Sec.
3.80(b)(4), and Sec. 3.80(b)(5), respectively, in the proposed
rule), regarding minimum space requirements for primary enclosures
containing nonhuman primates.
Because this new rule replaces the current standards, we are
providing in this rule that, where standards currently exist with
regard to the provisions listed above, those existing standards
must be complied with during the period prior to February 15, 1994.
This will enable us to maintain the standards necessary for the
well-being of those animals whose care will be affected by the need
for structural changes. Although we are providing additional time
to comply with those new standards that require extensive
structural changes, it is nevertheless our intent to encourage
facilities to make those changes and come into compliance with the
new standards as soon as possible.
Subpart A--Dogs and Cats
Regulations for humane handling, care, treatment, and
transportation of dogs and cats are contained in 9 CFR part 3,
subpart A. These regulations include minimum standards for
handling, housing, feeding, watering, sanitation, ventilation,
shelter from extremes of weather and temperature, veterinary care,
and transportation.
It should be noted that the regulations, as discussed in this
final rule, apply only to live dogs and cats. In our August 15,
1990, proposal, we proposed to revise and rewrite the existing
regulations based on our experience administering them. We also
proposed to amend our regulations to add requirements for the
exercise of dogs. This is specifically required by the 1985
amendments to the Act. (See 1752, 99 Stat. 1645, Pub. L. 99-198,
amending section 13 of the Act). We discuss below each topic
covered in our proposal.
Several commenters recommended that adequate provisions for
exercise and socialization be provided for cats as well as dogs. As
we discussed in our proposal, one of our specific obligations under
the 1985 amendments to the Act was to establish requirements for
the exercise of dogs. In response to that mandate, we included such
provisions in our proposal. However, the Act does not specifically
require that we establish exercise requirements for cats, and based
on the information we have reviewed, we do not feel it is necessary
or appropriate to require exercise and socialization for cats.
Housing Facilities and Operating Standards
Existing Secs. 3.1 through 3.3 provide requirements for
facilities used to house dogs and cats. Existing Sec. 3.1,
"Facilities, general," contains regulations pertaining to housing
facilities of any kind. It is followed by existing Sec. 3.2,
"Facilities, indoor," and Sec. 3.3, "Facilities, outdoor." In our
proposed rule, we proposed to amend these sections to provide for
an environment that better promotes the health, comfort, and well-
being of dogs and cats. We also proposed to add sections that
provide regulations specifically governing two other types of
facilities used to house dogs and cats--sheltered housing
facilities, and mobile or traveling housing facilities. The term
"sheltered housing facility" is defined in part 1 of the
regulations as "A housing facility which provides the animals with
shelter; protection from the elements; and protection from
temperature extremes at all times. A sheltered housing facility may
consist of runs or pens totally enclosed in a barn or building, or
of connecting inside/outside runs or pens with the inside pens in
a totally enclosed building." The term "mobile or traveling housing
facility," also included in part 1, is defined as "a transporting
vehicle such as a truck, trailer, or railway car, used to house
animals while traveling for exhibition or public education
purposes."
Some of the regulations we proposed for housing facilities are
applicable to housing facilities of any kind. As in the existing
regulations, we proposed to include these standards of general
applicability in one section, proposed Sec. 3.1, that would also
include many of the provisions in existing Sec. 3.1. Additionally,
we proposed amendments to the existing regulations that are
specific to particular types of housing facilities, and included
those provisions in separate sections of the proposed regulations.
In some cases where the existing regulations would have been
unchanged in substance, we made wording changes to clarify the
intent of the regulations.
Several commenters recommended that we require that housing
facilities comply with Federal, State, and local laws and
regulations relating to housing facilities for dogs and cats, so as
to allow uniform enforcement by various jurisdictions. We are
making no changes based on these comments. We are authorized under
the Act to establish minimum standards for animal welfare. This
mandate is different than those under other Federal, State, and
local laws.
One commenter requested that we combine the provisions regarding
sheltered housing facilities and outdoor housing facilities to
avoid confusion over which is which. As defined in part 1 of the
regulations, sheltered and outdoor housing facilities are two
distinct types of facilities. Because of the differences between
the two, we consider separate regulations necessary for each.
Housing Facilities, General
Housing Facilities; Structure; Construction--Section 3.1(a)
We proposed in Sec. 3.1(a) to require that housing facilities for
dogs and cats be designed and constructed so that they are
structurally sound. We proposed that they must be kept in good
repair, and that they must protect the animals from injury, contain
the animals securely, and restrict other animals and unauthorized
humans from entering. A small number of commenters specifically
supported these provisions as written. A large number of commenters
addressed the issue of restricting the entrance of unauthorized
humans, stating that the responsibility for maintaining adequate
security at a facility belongs to the facility, and not to the
Department of Agriculture. Others were concerned that, even if the
facility made reasonable efforts to prevent the entry of
unauthorized humans, the facility would still be liable for the
entry of trespassing individuals. Because, unlike nonhuman
predators and pests, it may be virtually impossible to prevent the
unauthorized entry of humans, it will not be a violation of these
regulations for facilities to fail to prevent such entry. In this
final rule, we are therefore removing the requirement, as proposed
in Secs. 3.1 (a) and (b), that facilities restrict the entry of
unauthorized humans.
A small number of commenters stated that the provision that
facilities restrict the entry of other animals was unnecessarily
stringent. One commenter stated that reasonable efforts to comply
with this provision should be sufficient. Others requested
clarification of the definition of "other animals." We continue to
believe that the provision is adequate as written. Unlike the
forced entry of unauthorized humans, entry by other animals can be
prevented by structural safeguards. Our implicit intent in
requiring that other animals be restricted from entering the
facility was to bar the entry of animals that could be detrimental
to the health and well-being of the animals housed at the facility.
One commenter recommended that facilities be required only to
reasonably protect animals from injury. We are making no changes
based on this comment. We do not consider it unreasonable to
require facilities registered or licensed under the Act to ensure
the well-being of the animals in their custody.
Housing Facilities: Condition and Site--Section 3.1(b)
In proposed Sec. 3.1(b), we proposed to add the requirement that
a dealer's or exhibitor's housing facilities be physically
separated from any other business. When more than one entity
maintains facilities on the premises, the increased traffic,
equipment, and materials in proximity to the animals can be
detrimental to the animals' well-being. Also, in cases where more
than one entity maintains animals on a premises, it can be
difficult to determine which entity is responsible for which
animals and for the overall conditions. To avoid this difficulty,
we proposed to require that housing facilities other than those
maintained by research facilities and Federal research facilities
be separated from other businesses. We did not propose to impose
this requirement on research facilities, because they are often
part of a larger sponsoring establishment, such as a university or
pharmaceutical company, and responsibility for animal and site
conditions rests with that establishment. Therefore, we have not
encountered the enforcement difficulties noted above with respect
to research facilities. One commenter specifically supported
these provisions as written. Several commenters recommended that we
require that all holding facilities and broker operations be
operated in a building separate from the owner's dwelling or living
quarters, with the exception of administrative offices. We do not
consider the location of a licensee's dwelling relevant to the
welfare of the animals housed in a facility, and therefore are
making no changes based on this comment.
We also proposed in Sec. 3.1(b) to require that housing
facilities and areas used for storing animal food and bedding be
kept free of any accumulation of trash, waste material, junk,
weeds, and other discarded material, in order to prevent an
unsanitary condition and problems with diseases, pests, and odors.
The need for orderliness applies particularly to the areas where
animals are maintained in the housing facilities. Under our
proposal, these areas would have to be kept free of clutter,
including equipment, furniture, and stored material, but could
contain materials actually used and necessary for cleaning the
area, and fixtures or equipment necessary for proper husbandry
practices and research needs.
A small number of commenters took issue with these proposed
provisions. One commenter stated that weeds are not necessarily
detrimental to the welfare of animals. Others recommended that we
prohibit the conditions described only when they might negatively
affect the health and welfare of the animals, or that we reword the
proposed provision for clarity. We are making no changes based on
these comments. While weeds themselves may not be detrimental, they
interfere with such necessary practices as cleaning and rodent
control. We continue to believe that the wording as proposed is
necessary and enforceable.
Housing Facilities: Surfaces; General Requirements--Sections
3.1(c) (1) and (2)
We included in proposed Sec. 3.1(c) requirements concerning
housing facility surfaces that are common to all types of
facilities. We proposed to include requirements specific to
particular types of facilities in separate sections. In Sec.
3.1(c)(1), we proposed to require that the surfaces of housing
facilities either be easily cleaned and sanitized, or be removable
or replaceable when worn or soiled. These provisions also applied
to houses, dens, and other furniture-type fixtures or objects
within the facility.
Proposed Sec. 3.1(c)(1) also required that any surfaces that
come in contact with dogs and cats be free of jagged edges or sharp
points that might injure the animals, as well as rust that prevents
the required cleaning and sanitization. We proposed to allow rust
on metal surfaces, as long as it is not excessive and does not
reduce structural strength or interfere with proper cleaning and
sanitization.
We proposed in Sec. 3.1(c)(2) to require that all surfaces be
maintained on a regular basis and that surfaces that cannot be
easily cleaned and sanitized be replaced when worn or soiled.
A small number of commenters specifically supported these
provisions as written. One commenter expressed the opinion that the
provisions in proposed Sec. 3.1(c)(1) were redundant with the
requirements in proposed Sec. 3.10. We disagree. The requirements
in proposed Sec. 3.1(c)(1) are structural requirements for housing
facilities. The provisions in proposed Sec. 3.10 pertain to
cleaning and sanitization.
One commenter stated that rusted areas cannot be adequately
sanitized, and that rust affects structural strength and creates
harmful runoff, and therefore should be prohibited. Based on our
experience enforcing the regulations, we have not found superficial
rust to be a problem with regard to either structural strength or
sanitization. We are therefore making no changes based on this
comment.
Housing Facilities: Surfaces; Cleaning--Section 3.1(c)(3)
We proposed in Sec. 3.1(c)(3) to require that hard surfaces that
come in contact with dogs or cats be spot-cleaned daily and
sanitized at least every 2 weeks. Proposed Sec. 3.10(b) also
provided for various methods of sanitizing primary enclosures and
food and water receptacles. Because these methods are effective in
general for sanitization of hard surfaces that cats and dogs come
in contact with, any of them could be used for the sanitization
required by Sec. 3.1(c). We proposed that floors made of dirt,
absorbent bedding, sand, gravel, grass, or other similar material
would have to be raked or spot-cleaned with sufficient frequency to
ensure all animals the freedom to avoid contact with excreta. This
flooring material would have to be replaced if the raking and spot-
cleaning were not sufficient to prevent or eliminate odors, pests,
insects, or vermin infestation. We proposed that all other surfaces
would have to be cleaned and sanitized when necessary to satisfy
generally accepted professional and husbandry practices.
A small number of commenters stated that dogs or cats in large
open runs may not need to have those areas cleaned daily. The
regulations as proposed require only daily spot-cleaning of hard
surfaces with which the dogs and cats come into contact. We
consider such a requirement both practicable and necessary and are
making no changes based on the comments.
One commenter opposed the use of floors such as dirt, sand, and
gravel, stating that such materials cannot be adequately sanitized.
We are making no changes based on these comments. While it is
sometimes difficult to use standard sanitization procedures on such
surfaces, it is relatively simple to replace specific areas as
needed. Several commenters objected to the use of gravel surfaces
on the grounds that the use of such material was inhumane. Section
3.1(a) of this final rule requires that housing facilities must
protect the animals there from injury. In any cases where the use
of gravel is shown to be causing injury, it is prohibited under
Sec. 3.1(a).
Several commenters stated that sanitization should be required
either daily or weekly. The provisions as proposed stated that
sanitization must be carried out at least every two weeks, and more
often if necessary to prevent an accumulation of dirt, debris, food
waste, excreta, and other disease hazards. Based on our experience
enforcing the regulations, we consider such provisions adequate for
proper sanitization.
The regulations as proposed required cleaning to prevent any
accumulation of excreta. Many commenters stated that it would be
impossible to prevent all accumulation of excreta, and recommended
that we delete the word "any" before the word "accumulation." We
consider the commenters' point a valid one and are making the
recommended change.
One commenter requested that we define "hard surfaces." We
consider the term self-explanatory and are making no changes based
on the comment.
Facilities: Water and Electric Power--Section 3.1(d)
In the existing regulations, Sec. 3.1(b) specifies that reliable
and adequate water and electric power must be made available "if
required to comply with other provisions of this subpart." In our
proposed rule, we set forth provisions concerning water and
electric power in Sec. 3.1(d). We proposed there to eliminate the
qualifying statement cited above, and to require that all
facilities have reliable and adequate electric power and potable
running water for the dogs' and cats' drinking needs, for cleaning,
and for carrying out other husbandry requirements.
A small number of commenters supported the proposed provisions as
written. Several commenters recommended that facilities be required
to provide both hot and cold water. Several other commenters stated
that the water available should be required to be potable only if
used for drinking. We are making no changes to our proposal based
on these comments. Because methods of sanitation exist that do not
require hot water, we disagree that hot water is a necessity for
adequate maintenance of a housing facility. However, we do consider
it necessary to require that all water provided be potable, because
it is difficult, if not impossible, to ensure that dogs and cats
will not drink from puddles left from cleaning the facility.
Housing Facilities: Storage--Section 3.1(e)
We proposed in Sec. 3.1(e) to expand the regulations in existing
Sec. 3.1(c) concerning proper storage of food and bedding supplies.
The proposed provisions retained the requirements that food and
bedding be stored so as to protect them from vermin infestation or
contamination. Additionally, we proposed requirements to ensure
further the quality of the food and bedding used by animals, and
therefore of the area in which the animals are housed. We specified
that open supplies of food and bedding would have to be stored in
leakproof containers with tightly fitting lids to protect the
supplies from spoilage and contamination. We proposed to require
that the supplies be stored off the floor and away from the walls,
to allow cleaning around and underneath them. We also proposed to
require that food requiring refrigeration be stored accordingly,
and that all food be stored so as to prevent contamination or
deterioration of its nutritive value. Under the proposal,
substances toxic to dogs and cats would not be allowed to be stored
in food storage and preparation areas, but could be stored in
cabinets in the animal areas.
A small number of commenters supported the proposed provisions as
written. A small number of commenters stated that storage of food
and bedding near walls should be permissible. We continue to
believe that the provision restricting storage near walls is
necessary to allow for cleaning and pest control and are making no
changes to the proposal based on these comments.
Several commenters recommended that we require that food be
stored in accordance with either manufacturer's recommendations,
generally accepted practice, or human food service guidelines. We
consider the intent of the commenters' recommendations to be met by
the proposed requirement that all food be stored in a manner that
prevents contamination and deterioration of its nutritive value.
A small number of commenters recommended that the regulations be
less specific than proposed regarding where toxic substances may be
stored, and require only that known toxic substances be stored in
a manner so as to prevent accidental contamination of food products
and contact with dogs and cats. We continue to believe that the
well-being of the animals requires that no toxic substances be
stored in food storage and preparation areas, and are retaining
that provision in this final rule. Further, we continue to believe
that because of the danger of toxicity to the animals housed, it is
necessary to require that toxic substances stored in animal areas
be kept in cabinets. We are therefore making no changes based on
the comments.
One commenter stated that if toxic materials are stored in
animal areas, it should be required that appropriate materials for
cleaning up a spill be available. We do not consider such a
requirement necessary. Provisions exist elsewhere in the
regulations to ensure that the facility is maintained in such a way
as to prevent injury to the animals. It will be incumbent upon the
facility to ensure that they have the proper materials to comply
with these provisions. In setting forth our proposal, our intent
was to limit the toxic materials that may be housed in animal areas
to those required for normal husbandry practices. We are therefore
adding wording to Sec. 3.1(e) to clarify that intent.
One commenter stated that facilities should be allowed to adopt
their own strategies for storing feed and chemicals, because the
cost of providing additional storage space would be considerable.
We consider the storage requirements proposed to be the minimum
necessary, and to be in accordance with generally accepted
husbandry and feed storage practices. We are therefore making no
changes based on the comment.
Several commenters stated that instead of requiring that open
supplies of food and bedding be stored in leakproof containers, the
regulations should require that such supplies be stored in
containers that will prevent contamination and spoilage. Based on
our experience enforcing the regulations, we consider leakproof
containers necessary to prevent contamination and spoilage, and are
therefore making no changes based on these comments.
Housing Facilities: Drainage and Waste Disposal--Section 3.1(f)
In Sec. 3.1(f) as proposed, the requirement was retained that
housing facilities provide for removal and disposal of animal and
food wastes, bedding, dead animals, and debris, as provided in
existing Sec. 3.1(d). We proposed to clarify this requirement to
include all fluid wastes and to include a provision that
arrangements must be made for regular and frequent collection,
removal, and disposal of wastes, in a manner that minimizes
contamination and disease risk. We also proposed to require that
trash containers be leakproof and be tightly closed, and that no
forms of animal waste, including dead animals, be kept in food and
animal areas.
Requirements for drainage are contained in existing Secs. 3.2(e)
and 3.3(d), under the sections concerning indoor facilities and
outdoor facilities, respectively. Since all types of animal housing
facilities, including our proposed categories of sheltered housing
facilities and mobile or traveling housing facilities, must have
some way of disposing of waste and liquids, we proposed to
consolidate all drainage and waste disposal requirements in
proposed Sec. 3.1(f).
Both existing Secs. 3.2(e) and 3.3(d) require that a suitable
method of eliminating excess water be provided. We proposed to
retain that requirement and expand it to pertain to sheltered and
to mobile or traveling housing facilities as well. Existing Sec.
3.2(e) requires that any drains used be properly constructed and
kept in good repair to guard against foul odors. Additionally,
where closed drainage facilities are used, they must be equipped
with traps and be installed so that they prevent the backflow of
odors and the backup of sewage onto the floor. We proposed to
retain these provisions and expand them for indoor facilities, and
proposed that the expanded provisions would also apply to other
types of facilities where such drainage is appropriate.
We also proposed to require that disposal and drainage systems
minimize vermin and pest infestation, and disease hazards. As part
of this safeguard, we proposed to require that any sump or
settlement pond, or similar system for drainage and animal waste
disposal, be located an adequate distance from the animal area of
the housing facility. We also proposed to require that standing
puddles of water in animal areas be promptly mopped up or drained
so that the animals stay dry.
A small number of commenters specifically supported the
provisions of proposed Sec. 3.1(f) as written. A large number of
commenters interpreted our provisions regarding the prevention of
odor and sewage as a requirement that closed drainage systems
include backflow valves. Many commenters stated that installing
such valves would be prohibitively expensive. The use of backflow
valves was not specifically required in the proposed regulations.
The provisions in question called for essentially the same
standards as those already required under the existing regulations.
We therefore do not expect facilities to experience significant
practical or financial difficulties in meeting the standards.
A small number of commenters asserted that adequate provision to
preclude direct contact of animals with sewage or other wastes was
included in Sec. 3.10 of the proposal. We do not agree. Section
3.10 as proposed addresses cleaning, sanitization and housekeeping,
but does not directly address drainage requirements.
One commenter recommended that we change the proposed requirement
that animal waste and water be rapidly eliminated and that the
animals be kept dry to read only that animal waste and water be
adequately eliminated. We continue to believe that the wording of
the proposal adequately conveys the intent of the proposed standard
and are making no changes based on the comment.
A number of commenters recommended that we eliminate the proposed
requirement that standing puddles of water in animal enclosures be
drained or mopped up. These commenters stated that no evidence
exists that dogs exercised in the rain suffer any deleterious
effects. We do not consider pet animals being exercised in the rain
by their owners to be parallel with animals housed within a
facility. Because of the confined nature of such facilities, we
consider the provision as proposed necessary to decrease the
likelihood of contamination of the animals.
A number of commenters recommended that the regulations require
that waste be removed from within the facility daily. One commenter
recommended that such removal should occur twice daily. As
proposed, removal of wastes must take place on a regular and
frequent basis. We continue to believe that such a requirement will
adequately protect the well-being of the animals, and are making no
changes to that provision.
A number of commenters opposed the proposed requirement that
trash containers have lids. We are making no changes based on these
comments. We consider the covering of trash containers as necessary
to control insects and odors. Under these regulations, the use of
lids is required only in animal areas and food storage and
preparation areas, not in office areas.
A number of commenters addressed the issue of sump ponds. A
small number of commenters recommended that open sump ponds be
prohibited. Several commenters recommended that the regulations
include a specific minimum distance from research facilities that
sump ponds may be located. As we stated in our proposal, based on
our experience enforcing the regulations, we believe that sump
ponds can be used without health risk if located an adequate
distance from a facility. However, what constitutes an appropriate
distance will often vary according to the size and configuration of
the pond and the topography surrounding the facility. We believe
this rule addresses these variables adequately and we are making no
changes based on the comments.
A small number of commenters recommended that we add to our
provisions regarding sump or settlement ponds the requirement that
they be located far enough away from the facility to prevent the
spread of diseases through the sewage system to the animal area. We
are not aware of disease spread in such a manner having been a
problem to date and are therefore making no changes based on these
comments.
Several commenters stated that the wording we used to restrict
storage of dead animals, animal parts, and animal waste was
repetitive. We consider the wording used for the provision in
question necessary for proper enforcement, and are making no
changes based on the comments. One commenter stated that the
prohibition of the storage of animal parts in food areas should not
preclude storing canned food in refrigerators along with
blood/serum samples. We are making no changes based on this
comment. We believe that the danger of contamination of foodstuffs
by animal parts can be significant, and that a general prohibition
on commingling the two is necessary on a practical level for proper
enforcement.
Housing Facilities: Washrooms and Sinks--Section 3.1(g)
In proposed Sec. 3.1(g), we proposed to retain the requirement in
existing Sec. 3.1(e) that washing facilities be available to animal
caretakers for their own cleanliness, and to include it in proposed
Sec. 3.1(g). As proposed, facilities would be required to provide
readily accessible washrooms, basins, sinks, or showers for animal
caretakers. A small number of commenters recommended that showers
be required. Conversely, several commenters expressed concern
whether facilities with showers alone would meet the regulations.
We are making no changes based on these comments. While we agree
that showers can constitute adequate washing facilities, we do not
consider them the only appropriate method of ensuring employee
hygiene.
Temperatures in Housing Facilities
Temperature Requirements in Enclosed Facilities--Sections 3.2(a),
3.3(a), and 3.5(a)
We proposed that enclosed housing facilities--that is, indoor
facilities, the sheltered portion of sheltered housing facilities,
and mobile or traveling facilities--be sufficiently heated and
cooled when necessary to protect the dogs and cats from temperature
extremes and to provide for their health and well-being. We set
forth the heating and cooling requirements for each of the above
categories in Secs. 3.2(a), 3.3(a), and 3.5(a) respectively. We
proposed to set forth ventilation requirements in Secs. 3.2(b),
3.3(b), and 3.5(b) respectively.
In establishing minimum temperatures for these facilities, the
proposed regulations took into account whether a particular dog or
cat housed there is acclimated to relatively low temperatures, and
whether for some other reason, either because of breed, age, or
condition, a dog or cat should not be subjected to certain low
temperatures. In Sec. 3.2(a) of the existing regulations for indoor
facilities, the minimum temperature allowed is 50 deg.F (10 deg.C)
for all dogs and cats in those facilities that are not acclimated
to lower temperatures. We proposed that in indoor, sheltered, and
mobile or traveling housing facilities, the minimum temperature
allowed continue to be 50 deg.F (10 deg.C) for dogs or cats not
acclimated to lower temperatures. Because some dogs cannot be
acclimated to lower temperatures, we also proposed to apply the 50
deg.F (10 deg.C) minimum to breeds of dogs or cats that cannot
tolerate lower temperatures without stress and discomfort (e.g.,
short-haired breeds such as beagles, greyhounds, and Dobermans),
and to dogs and cats that are sick, aged, young, or infirm. We
proposed that exceptions to the 50 deg.F (10 deg.C) minimum could
be made upon approval of the attending veterinarian, and that the
minimum temperature for all other dogs and cats would be 35 deg.F
(1.7 deg.C).
In the existing regulations, there is no maximum temperature
specified for indoor housing facilities, although auxiliary
ventilation is required when the temperature rises to or above 85
deg.F (29.5 deg.C). In the proposed rule, we established a maximum
temperature of 95 deg.F (35 deg.C) for indoor facilities, mobile or
traveling facilities, and the sheltered part of sheltered housing
facilities, when those facilities contain dogs or cats. For each of
those categories of shelters, we proposed that auxiliary
ventilation, such as fans or air conditioning, would have to be
used when the temperature rises to or above 85 deg.F (29.5 deg.C).
We received a large number of comments with regard to the
temperature in indoor, sheltered, and mobile and traveling housing
facilities. A number of commenters recommended specific temperature
ranges that were more stringent than those included in our
proposal. A number of commenters stated either that our proposed
temperature ranges were too narrow, or that they did not leave
enough latitude for professional judgment on the part of the
attending veterinarian in the case of individual animals or breeds.
We continue to believe that the well-being of dogs and cats housed
in enclosed facilities requires that parameters be established for
hot and cold temperatures. Although the regulations as proposed
provide the attending veterinarian some latitude in deciding
whether unacclimated dogs and cats may be exposed to temperatures
lower than an otherwise specified limit, we do not believe that the
needs of the animals housed vary so widely as to warrant removing
all temperature limits.
A number of commenters stated that the 35 deg.F and 95 deg.F
limits we proposed were too lenient. On the other hand, a large
number of commenters stated that the limits we proposed did not
adequately take into account acclimated animals that can tolerate
temperatures outside those limits. Upon review of the comments, we
consider both viewpoints to have some merit. While the limits we
proposed may become intolerable to certain animals at the extremes,
we agree that animals can become acclimated to temperatures outside
those limits. Therefore, in this final rule, we are establishing
general temperature limits more stringent than those proposed,
while at the same time allowing flexibility to accommodate animals
that can tolerate temperatures outside those limits. We are
providing in this final rule that the ambient temperature in the
enclosed facilities must not fall below 45 deg.F (7.2 deg.C) for
more than 4 consecutive hours when dogs or cats are present, and
must not rise above 85 deg.F (29.5 deg.C) for more than 4
consecutive hours when dogs or cats are present.
A small number of commenters recommended that the regulations
require that alternative surfaces that allow the dogs and cats to
avoid surfaces such as concrete or metal be made available to every
animal when the temperature falls below 45 deg.F (7.2 deg.C), and
to sick, aged, infirm, or very small animals at other times. Upon
review of the comments, we agree that in order for certain dogs and
cats to tolerate cold temperatures, they must be able to conserve
their body heat. To allow for such conservation of body heat, we
are including in this final rule the requirement that enclosed
housing facilities provide dry bedding, solid resting boards, or
other methods of conserving body heat when temperatures are below
50 deg.F (10 deg.C).
Many commenters stated that short-haired breeds should not be
limited to a 50 deg.F (10 deg.C) minimum temperature, because some
short-haired breeds are what the commenters termed "winter hardy."
We are making no changes based on these comments. Although we
consider 50 deg.F a necessary minimum for the well-being of most
short-haired breeds, the regulations as proposed provided the
attending veterinarian the professional discretion to make
exceptions where appropriate. A small number of commenters objected
to the allowance of such exceptions. We continue to believe that
the professional education and experience of the attending
veterinarian enables him or her to make a professional judgment
based on the condition of the animal and the circumstances
involved, and that such flexibility is necessary to accommodate
differences in individual animals and situations.
One commenter stated that setting minimum and maximum
temperatures alone is not sound, and that standards should be
written that take into account temperatures, humidity, air
velocity, and acclimation requirements for breeds and species. To
the best of our knowledge, the comprehensive information described
by the commenter does not exist. Based on the information available
to us, and on our experience enforcing the regulations, we consider
the temperature limits we have set as minimum standards for the
health and well-being of the animals in question.
Several commenters, addressing the temperature requirements for
sheltered housing facilities, questioned whether the outdoor
portion of sheltered housing facilities must be closed off when the
temperature falls outside the allowable range for the enclosed
portion of the facility. Several commenters also requested that the
regulations clarify that sheltered housing facilities are not
required to control the temperature of the outside portion of those
facilities. We believe that common sense dictates that the outdoor
portion of sheltered housing facilities cannot be heated, and that
no further clarification is necessary in the regulations. In a
sheltered facility, the enclosed area must be available to the
animals at all times. There is therefore no reason to restrict the
animals from exiting to the outdoor portion if they choose.
Ventilation Requirements in Housing Facilities--Sections 3.2(b),
3.3(b), and 3.5(b)
The requirements for ventilation of indoor housing facilities
that are set forth in Sec. 3.2(b) of the existing regulations were
retained in the proposal, and were extended to apply to all
sheltered portions of sheltered, and mobile or traveling housing
facilities to provide for the health and well-being of dogs and
cats. Based on our inspections of dealer, exhibitor, and research
facilities, we proposed to add (1) That ventilation must also be
provided to minimize odors, drafts, ammonia levels, and moisture
condensation in these housing facilities; (2) that ventilation in
mobile or traveling facilities must minimize exhaust fumes; and (3)
that in indoor housing facilities and the sheltered part of
sheltered housing facilities, the relative humidity must be
maintained at a level that ensures the health and well-being of the
dogs or cats housed in the facility, in accordance with the
directions of the attending veterinarian and generally accepted
professional and husbandry practices.
A small number of commenters specifically supported the
ventilation requirements in the proposed rule. A small number of
commenters recommended that it be required that the relative
humidity in indoor facilities be maintained between 30 and 70
percent. Others recommended in general that specific ventilation
standards be established to eliminate disagreements between
inspectors and facilities. We are making no changes based on these
comments. The effect on animals of a particular level of humidity
depends to a great degree on other factors, such as temperature and
ventilation. We therefore consider it appropriate as proposed to
allow professional discretion regarding exact humidity levels.
A small number of commenters stated that it is unnecessary to
require as proposed that auxiliary ventilation be used at
temperatures equaling or exceeding 85 deg.F (29.5 deg.C), because
the regulations as proposed require in general that facilities be
sufficiently ventilated to provide for dogs' and cats' health and
well-being. While we agree that the requirement for auxiliary
ventilation at higher temperatures falls under the general
requirement for adequate ventilation, we continue to believe that
it serves a specific and necessary purpose. Based on our experience
enforcing the regulations, achieving adequate ventilation at
moderate temperatures can be accomplished through various means,
such as either natural or mechanical ventilation. However, at
higher temperatures, auxiliary ventilation becomes necessary on a
uniform basis in ensuring the health and well-being of the animals.
We are therefore making no changes based on the comments.
A number of commenters opposed the requirement for auxiliary
ventilation at 85 deg.F in cases where animals are acclimated to
such conditions. We are making no changes based on these comments.
Because an animal is acclimated to high temperatures under one set
of conditions does not ensure that it can tolerate those same
temperatures under all conditions. It is the combination of
temperature, humidity, and ventilation, along with whether an area
is open or enclosed, that determines whether conditions are
tolerable. Because the effect of a high temperature is heightened
in a confined space, we consider it necessary that auxiliary
ventilation be provided for all dogs and cats housed in enclosed
areas when the temperature reaches or exceeds 85 deg.F.
A small number of commenters stated that the regulations should
require that auxiliary ventilation be used in mobile or traveling
housing facilities when the ambient temperature reaches 75 deg.F.
The commenters' recommendations were not supported by additional
data as to why the change from our proposal would be necessary, and
we are making no changes based on this comment.
One commenter expressed concern that determining what constitutes
excessive odor will involve a subjective evaluation. The
requirement that odors be minimized is included in the existing
regulations. While we agree that it does not lend itself to precise
measurement, we consider the word "minimize" to be sufficiently
measurable for enforcement purposes.
Lighting Requirements in Housing Facilities--Sections 3.2(c),
3.3(c), and 3.5(c)
In the proposed regulations, we retained the requirement in Sec.
3.2(c) of the existing regulations that indoor housing facilities
have ample light to permit routine cleaning and inspection, and
proposed also that it must allow observation of the dogs and cats.
We proposed to apply these requirements to all of the enclosed
housing facilities included in the proposed regulations. We also
proposed to require in each case that either natural or artificial
light be provided according to a regular diurnal lighting cycle,
and that sufficient light be provided to aid in maintaining good
housekeeping practices, adequate cleaning, adequate inspection of
animals, and for the well-being of the animals. Also, in our
proposal, we retained the requirement in the existing regulations
for indoor facilities that primary enclosures be placed so as not
to expose the animals in them to excessive light, and we proposed
to extend that requirement to sheltered enclosures.
A small number of commenters specifically supported the lighting
requirements as proposed. Several commenters responded to the
statement we originally made in the supplementary information of
our original proposal that an example of excessive lighting might
involve an animal housed in the top cage of a stack of cages near
a light fixture. The commenters stated that there is no evidence
that dogs and cats are harmed by the level of light generated by
artificial sources when housed in top cages. We recognize that not
all animals housed in top cages are exposed to excessive light, and
have included no standards in the regulations specifically
addressing such housing. As we explained in our revised proposal,
and as we continue to believe, the example we provided involves
just one of a variety of situations that could constitute excessive
light.
A number of commenters objected to the proposed requirement for
lighting on a regular diurnal cycle, and recommended instead that
the regulations require a specific number of hours of light or
darkness each day. Upon review of the comments, we continue to
believe that it would not be beneficial in all cases to establish
one specific timetable for lighting. Such a specific timetable
might not be necessary or warranted in all cases, and might not
coincide with normal outdoor lighting cycles at a particular time
of year. The wording as proposed is designed to allow for
professional discretion regarding lighting appropriate to varying
situations.
A number of commenters objected to the provision in our proposal
that light in enclosed housing facilities be uniformly diffused.
One commenter stated that the uniform diffusion of light in a
facility is technically impossible. The requirement in our proposal
for the uniform diffusion of light is very similar to the
requirement in the existing regulations for "uniformly distributed
illumination." Our intent in retaining the requirement for uniform
lighting was to allow for proper cleaning, observation of animals,
and inspection, without the need for an additional light source,
such as a flashlight. We consider this standard to be both
necessary and attainable.
One commenter stated that the lighting standards were only
minimal. As we discussed in our revised proposal, it is our purpose
throughout the regulations to establish minimum standards for the
health and well-being of regulated animals. Although we encourage
practices that exceed the minimum, we consider the standards in
this final rule adequate to meet their purpose.
In our proposal, the lighting requirements for mobile or
traveling housing facilities did not contain a prohibition of
excessive lighting. One commenter stated that such a prohibition
should be included. Because of the nature of mobile and traveling
housing facilities, and the electrical and lighting systems present
in such facilities, we have not found excessive lighting there to
be a problem. We are therefore making no changes based on the
comment.
Specific Provisions for Indoor Housing Facilities--Section 3.2(d)
Section 3.2(d) of the existing regulations, regarding the
interior surfaces of indoor housing facilities, requires that those
surfaces be substantially impervious to moisture and readily
sanitized. In Sec. 3.2(d) of the proposed regulations, we retained
the requirement that all surfaces be impervious to moisture, but
made an exception in the case of ceilings that are replaceable. An
example of this would be a suspended ceiling with replaceable
panels. The requirements we proposed concerning interior surfaces
are more stringent for indoor housing facilities than for any other
type of facility. Only for indoor facilities, for example, did we
propose that ceilings have to be either impervious to moisture or
replaceable. This is because indoor facilities generally operate on
one ventilation system, and any disease organisms or excessive
odors that occur in the facility might spread throughout the
facility, requiring a thorough cleaning or replacement of all
interior surfaces.
A number of commenters specifically supported the proposed
provisions as written. Several commenters stated that ceilings
should always be impervious to moisture, and recommended that we
delete the provision that they may be replaceable. We are making no
changes based on this comment. In many cases, replacing a ceiling
would be more effective in minimizing disease risk than cleaning
it.
A small number of commenters recommended that the proposed
provisions regarding ceilings be changed to require that the
ceiling be kept clean and dry. We consider the proposed wording
adequate to convey this intent and are making no changes based on
these comments.
One commenter stated that the requirement for impervious or
replaceable ceilings discriminates against research facilities,
because ceilings are not addressed with regard to mobile, outdoor,
and sheltered facilities. The requirement for impervious or
replaceable ceilings has nothing to do with the purpose of a
facility. As we explained in our proposal, we consider the more
stringent requirement necessary for indoor facilities because
indoor facilities generally operate on one ventilation system, and
any disease organisms or excessive odors that occur in the facility
might spread throughout the facility, requiring a thorough cleaning
or replacement of all interior surfaces.
A number of commenters objected to our proposed requirement that
certain areas of indoor facilities be impervious to moisture, and
recommended instead that the proposal call for surfaces that are
either moisture retardant or repellant. Some of these commenters
stated that surfaces impervious to moisture might not allow for
secure footing. We are making no changes based on these comments.
We do not agree that because a surface is impervious to moisture
implies that it causes insecure footing. We also do not consider
moisture-retardant surfaces adequate to achieve the necessary end,
which is prevention of the absorption of fluids and wastes. The
intent of the provision was to facilitate cleaning and sanitation
and to decrease odors and disease hazards. We continue to consider
impervious surfaces in indoor facilities necessary to achieve these
ends.
Specific Provisions for Sheltered Housing Facilities--Sections
3.3 (d) and (e)
In proposed Sec. 3.3(d) regarding sheltered housing facilities,
we set forth the requirement that dogs and cats be provided with
adequate shelter and protection from the elements to protect their
health and well-being.
In order to maintain sanitary conditions in sheltered housing
facilities, we proposed to establish the following requirements in
Sec. 3.3(e). Under our proposal, the following areas would have to
be impervious to moisture: (I) Indoor floor areas in contact with
the animals; (2) outdoor floor areas not exposed to the direct sun
or made of a hard material such as wire, wood, metal, or concrete,
in contact with the animals; and (3) all walls, boxes, houses,
dens, and other surfaces in contact with the animals. We proposed
that outside floor areas in contact with the animals and exposed to
the direct sun could consist of compacted earth, absorbent bedding,
sand, gravel, or grass.
A small number of commenters specifically supported the
provisions regarding sheltered housing facilities as written.
Several commenters, in referring to shelter at sheltered housing
facilities, recommended specific protection from heat for
traditional dog houses. In general, we do not expect the use of
traditional dog houses in sheltered housing facilities and are
making no changes based on these comments.
One commenter requested that we define "adequate shelter." We
consider the meaning of "adequate shelter" to be clear in Sec. 3.3
as proposed and are making no changes based on this comment.
A small number of commenters recommended that we reword our
proposed requirements regarding shelter to make it clear that the
sheltered housing facility must be large enough to provide all the
animals present with shelter from the elements at the same time. We
agree that it would be beneficial for the animals involved to
clarify that shelter must accommodate all animals comfortably. We
are therefore adding wording to Sec. 3.3(d) as proposed to require
that the shelter structures must be large enough to allow each
animal to sit, stand, and lie in a normal manner and to turn about
freely.
One commenter stated that the provisions regarding exposure to
direct sun should include a specific duration of such exposure. The
intent of those provisions was that the floor areas in question
must be exposed to sunlight at some time during the day. Based on
that intent, we do not consider it necessary to specify a duration
of sunlight.
One commenter stated that outdoor floor areas should not be
restricted solely to those materials listed in Sec. 3.3(e)(2)
(compacted earth, absorbent bedding, sand, gravel, or grass). The
proposed regulations as written do not restrict outside areas to
the surfaces listed in Sec. 3.3(e)(2). Examples of alternative
surfaces are provided in Sec. 3.3(e)(1)(ii).
Specific Provisions for Outdoor Housing Facilities--Section 3.4
The intent of Sec. 3.3 of the existing regulations is to provide
adequate standards for the care of animals housed outdoors.
However, our inspections of dealers' and exhibitors' facilities in
climates with temperature extremes have indicated that some
licensees are not meeting what we believe should be minimum
standards for the treatment of dogs and cats. Specifically, we
consider it necessary to make the regulations more stringent
regarding the types of dogs and cats that can be kept outdoors, and
regarding what shelter is necessary for dogs and cats kept
outdoors. Therefore, we proposed to revise the existing
requirements for outdoor facilities, to make them more clearly
defined and more stringent.
Because outdoor facilities cannot be temperature-controlled, it
is necessary to judge a dog's or cat's suitability for outdoor
housing on an individual basis. We set forth provisions in proposed
Sec. 3.4(a)(1) that a dog or cat could not be kept in an outdoor
facility, unless specifically approved by the attending
veterinarian, if (1) it is not acclimated to the temperatures
prevalent in the area or region where the facility is located; (2)
it is of a breed that cannot tolerate the prevalent temperatures of
the area without stress or discomfort (such as short-haired breeds
in cold climates); or (3) it is aged, young, sick or infirm. We
recognize that in some situations, particularly in the case of dogs
or cats obtained from pounds, it will not be known whether an
animal has been acclimated to prevailing temperatures. Therefore,
in proposed Sec. 3.4(a)(2), we provided that if a dog's or cat's
acclimation status is unknown, it must not be kept in an outdoor
facility when the ambient temperature is less than 35 deg.F (1.7
deg.C).
With regard to the type of shelter required for dogs and cats
housed outdoors, we believe that the existing regulations should be
expanded to specify what is necessary for better and more humane
treatment of the dogs and cats. In essence, the existing
regulations require that dogs and cats be provided with sufficient
shade to protect them from the direct rays of the sun, shelter to
keep them dry during rain or snow, and shelter when the atmospheric
temperature falls below 50 deg.F (10 deg.C). Additionally, bedding
or some other protection is required when the ambient temperature
falls below that to which the dog or cat is acclimated.
In Sec. 3.4(b) of the proposed rule, we set forth the requirement
that all outdoor facilities housing dogs or cats include one or
more shelter structures that are accessible to all animals in the
facility, and that are large enough to allow all animals in the
structure to sit, stand, and lie in a normal manner, and to turn
about freely. We proposed in Sec. 3.4(b) that the shelter structure
would have to: (1) Provide adequate shelter and protection from the
cold and heat; (2) be protected from the direct rays of the sun and
the direct effect of wind, rain, or snow; (3) have a wind break and
a rain break at its entrance; (4) contain clean, dry, bedding
material; and (5) include a roof, four sides, and a floor. We also
proposed in Sec. 3.4(b) that in addition to the shelter structure,
there would have to be one or more separate outside areas of shade
provided, large enough to contain all the animals at one time and
to protect them from the direct rays of the sun.
In proposed Sec. 3.4(c), we set forth the requirement that all
building surfaces that are in contact with dogs or cats in outdoor
housing facilities be impervious to moisture. We specified that
metal barrels, cars, refrigerators or freezers, and the like would
not be permitted as shelter structures, and that the floors of
outdoor housing facilities could be of compacted earth, absorbent
bedding, sand, gravel, or grass, but would have to be kept clean.
A small number of commenters specifically supported the
provisions regarding outdoor housing facilities as written.
A small number of commenters objected to the 35 deg.F minimum for
dogs and cats at outdoor housing facilities, when the acclimation
status of those animals is unknown. One of these commenters stated
that the proposed 35 deg.F minimum was inconsistent with the 50
deg.F proposed minimum in indoor and sheltered housing facilities
for dogs not acclimated to lower temperatures. We agree that
temperatures below 50 deg.F can be just as hazardous to
unacclimated animals at outdoor facilities as at indoor and
sheltered housing facilities, and are therefore providing in this
final rule that dogs and cats whose acclimation status is unknown
must not be kept in outdoor facilities when the ambient temperature
is less than 50 deg.F (10 deg.C).
A small number of commenters stated that the minimum temperature
for dogs and cats of unknown acclimation status should be removed,
and responsibility for such decisions left to the attending
veterinarian. We do not agree that the attending veterinarian can
make a valid decision regarding an animal's tolerance without
knowing its acclimation status and are making no changes based on
these comments.
Many commenters recommended that we delete short-haired breeds in
cold climates as an example of dogs or cats that must not be housed
in outdoor facilities. We are making no changes based on these
comments. Most short-haired breeds cannot tolerate cold
temperatures. In those cases where individual animals or breeds can
tolerate cold temperatures, the regulations as proposed allow for
professional discretion on the part of the attending veterinarian.
A small number of commenters objected to the proposed regulations
which allow the attending veterinarian to grant exceptions to the
general prohibition on housing certain dogs and cats outside. We
continue to believe that differences in animals and varying
situations make it necessary to allow for professional judgment in
certain cases. We also continue to believe that the attending
veterinarian is the individual best qualified to exercise this
judgment.
A small number of commenters stated that specific standards for
what constitutes "acclimation" should be included in the
regulations. We consider the term "acclimation" to be adequately
defined by normal usage, and do not consider it necessary to define
the term further. One commenter recommended that we delineate more
specifically which dogs and cats may not be housed outdoors. We
consider the provisions as proposed to be clear as written and are
making no changes based on this comment. One commenter stated that
the terms "sick," "infirm," "aged," and "young" should be defined.
We expect the attending veterinarian to exercise professional
judgment regarding these terms, and do not agree that specific
definitions beyond those which are commonly understood are
necessary or desirable.
One commenter stated that the wind chill factor must be
considered in the outdoor housing of dogs and cats. We agree, and
consider this factor to be addressed in Sec. 3.4(b) as proposed,
regarding shelter from the elements.
A number of commenters addressed the provisions in proposed Sec.
3.4(b), regarding shelter from the elements at outdoor housing
facilities. Several commenters recommended that a maximum of six
dogs be allowed per shelter. We do not consider such a limit
necessary. Proposed Sec. 3.6 of the regulations allows for a
maximum of 12 nonconditioned dogs per primary enclosure. We see no
reason to set a limit on conditioned animals, provided the space
and compatibility requirements otherwise required by the
regulations are met.
Several commenters requested definitions of "wind break" and
"rain break." We believe these terms are self-explanatory and need
no further clarification.
A small number of commenters stated that the shelters at outdoor
housing facilities should be required to be maintained at indoor
temperature ranges. We do not consider such a requirement
practical; nor do we consider it necessary in light of the other
specific requirements designed to ensure the health and well-being
of animals kept at outdoor housing facilities.
A small number of commenters addressed the issue of bedding
material at outdoor housing facilities, as required by proposed
Sec. 3.4(b)(4). Approximately half of these commenters opposed the
requirement for bedding, stating either that group-housed dogs
create their own heat, or that bedding materials can serve as
fomites for potential disease problems. Conversely, one commenter
stated that clean, dry bedding should be required at all times to
prevent sores. Another commenter requested that the regulations
specify the amount of additional bedding needed at cold
temperatures, so that compliance can be verified. We do not agree
that the requirement for bedding should be eliminated. We do not
consider it advisable to depend on group-housing of dogs to provide
adequate warmth at outdoor facilities. Nor do we believe that
potential disease hazards from bedding that is improperly cared for
should preclude the requirement for bedding material. We also do
not consider it practical or necessary to specify exactly how much
bedding should be provided. Such a decision should be based on
professional judgment regarding species, breed, and prevailing
conditions. With regard to requiring bedding to prevent sores, Sec.
3.1(a) of the standards requires that housing facilities protect
animals from injury. If the animals in a facility are suffering
from sores, then the facility must take measures to come back into
compliance with the regulations. Although the use of bedding is one
possible solution, we do not consider it necessary to impose a
uniform requirement for bedding in all cases.
A number of commenters addressed the provisions in proposed Sec.
3.4(c), regarding the construction of outdoor housing facilities.
A small number of commenters supported the proposed provisions as
written. A number of commenters took issue with our proposed
requirement that floor surfaces in outdoor housing facilities--if
made of compacted earth, sand, gravel, or grass--be replaced if
there are any prevalent odors, diseases, insects, pests, or vermin.
The commenters expressed the opinion that such materials cannot be
replaced. We disagree, and consider it both practical and feasible
to replace any of the materials listed.
Primary Enclosures--Section 3.6
In proposed Sec. 3.6, we proposed to amend existing Sec. 3.4,
"Primary enclosures." The existing section provides general
requirements for construction and maintenance of primary
enclosures, uniform space requirements for each dog or cat housed
in a primary enclosure, and provisions regarding litter and resting
surfaces for cats and the tethering of dogs on chains. We proposed
to expand the existing general requirements, to add some new
requirements, and to clarify the existing requirements in
accordance with the intent of the amendments to the Act.
A small number of commenters opposed in general the proposed
provisions regarding primary enclosures. A number of commenters
recommended that the regulations require that primary enclosures
comply with all applicable Federal, State, and local laws and
regulations. We disagree. As noted above, our mandate under the Act
may not necessarily be the same as those of other Federal, State,
and local laws. We do not consider it necessary to attempt to
require compliance with other laws to establish minimum standards
for primary enclosures.
Primary Enclosures: General Requirements--Section 3.6(a)
The provisions we set forth in proposed Sec. 3.6 regarding
primary enclosures contained requirements that all primary
enclosures meet certain minimum standards to help ensure the safety
and well-being of dogs and cats. A primary enclosure is defined in
Part 1 of the regulations as "any structure or device used to
restrict an animal or animals to a limited amount of space, such as
a room, pen, run, cage, compartment, pool, hutch, or tether."
Included among the primary enclosures subject to the proposed
regulations are those used by circuses, carnivals, traveling zoos,
educational exhibits, and other traveling animal acts and shows. In
Sec. 3.6(a) we proposed to continue to require that primary
enclosures be structurally sound and maintained in good repair to
protect the animals from injury, to contain them, and to keep other
animals out. We also proposed to require that the primary
enclosures keep unauthorized humans out. We proposed to continue to
require that the primary enclosures enable the animals to remain
dry and clean; that they provide the animals with convenient access
to food and water; that they provide sufficient space for the dogs
and cats to have normal freedom of movement; and that their floors
be constructed in a manner that protects the animals from injury.
With regard to this last requirement, we proposed to specify that
if the floors of primary enclosures are of mesh or slatted
construction, they must not allow the animals' feet to pass through
any openings in the floor.
We proposed to add requirements that the primary enclosures be
constructed without sharp points or edges, and that they provide
sufficient shade to the animals in the enclosures and protect them
from temperature extremes and other weather conditions that might
be uncomfortable or hazardous to the animals. We also proposed to
require that the primary enclosures be easily cleaned and
sanitized, or be replaceable when worn or soiled.
A number of commenters specifically supported the provisions in
proposed Sec. 3.6(a) as written.
Section 3.6(a)(2)(iv) of our proposal stated that primary
enclosures must be constructed so as to keep other animals and
unauthorized humans from entering the enclosures. A number of
commenters objected to this provision, stating that such security
is unnecessary for the primary enclosure because of similar
security measures required elsewhere in the regulations for the
housing facility itself. We disagree with the assertion of the
commenters. Even assuming that no unwanted animals would ever enter
the facility from the outside, there is still the risk that animals
within the facility might escape from their enclosures and pose a
risk to confined animals, unless the primary enclosures guard
against such risk. We are, however, deleting the requirement that
unauthorized humans be kept from entering the primary enclosures,
for the reasons set forth in this supplementary information under
the heading, "Housing Facilities: Structure; Construction--Sec.
3.1(a)."
Several commenters stated that the provisions in proposed Secs.
3.6(a)(2)(vi) and (a)(2)(vii), regarding protection from weather
conditions and the need for shade, respectively, were unnecessary,
because shelter and protection from the sun are already addressed
elsewhere in the regulations with regard to housing facilities in
general. Because housing facilities and primary enclosures are not
always the same or equivalent, the provisions as proposed are
necessary in both places in the regulations. We are therefore
making no changes based on these comments. One commenter objected
to the requirement that primary enclosures provide shelter because,
according to the commenter, although many types of primary
enclosures provide adequate protection when used in an enclosed
housing facility, they would not meet the criterion of supplying
sufficient shelter in areas not otherwise sheltered by the
facility. We are making no changes based on this comment. The
regulations do not require that a primary enclosure be able to
provide adequate shelter under circumstances that do not exist,
only that they properly protect the animals in them in any given
situation.
Several commenters recommended that Sec. 3.6(a)(2)(vi) make it
clear that shelter and protection from the elements must be
accessible to all animals in an enclosure at the same time, and
that similar clarification be added in Sec. 3.6(a)(2)(viii) with
regard to access to food and water We agree that such a change will
better convey the intent of the regulations and are so amending
this final rule.
A number of commenters addressed the provisions in proposed Sec.
3.6(a)(2)(x), requiring that, if primary enclosures have floors
that are of mesh or slatted construction, they do not allow the
dogs' and cats' feet to pass through any openings in the floor.
Some commenters opposed mesh flooring of any sort. A small number
of commenters expressed the opinion that flooring should always be
small mesh. Others were divided as to whether mesh should be
allowed that is large enough to permit passage of feces, even
though such flooring would probably also allow passage of a dog's
or cat's foot. Several commenters stated that floor mesh should be
large enough to allow the animals' feet to pass freely back and
forth. A small number of commenters stated that flooring designs
and materials should be researched individually to suit the
situation and the species involved.
We do not consider it practical or necessary to prohibit the use
of mesh floors. Many mesh designs can be used without detriment to
the animals involved. With regard to the size of openings in the
floor, the intent of the Act is to provide for the health and well-
being of the animals. Floors that can injure the animals by
allowing their legs to pass through do not comply with the intent
of the Act, whether or not they prohibit the passage of feces. We
do not consider ease of cleaning to be a higher priority than the
safety of the animals. We are therefore making no changes based on
these comments.
One commenter stated that, because wire or slatted mesh flooring
is uncomfortable and may be injurious to the animals enclosed, the
regulations should require that solid resting surfaces be provided
for both dogs and cats. We agree that certain types of flooring do
not allow any relief for the animals enclosed. We are therefore
adding a provision to Sec. 3.6(a)(2)(x) of this final rule to
require the following: If the floor of a primary enclosure is
constructed of wire, a solid resting surface or surfaces that, in
the aggregate, are large enough to hold all the occupants of the
primary enclosure at the same time comfortably, must be provided.
Section 3.6(a)(2)(xi) of our proposal states that primary
enclosures must be constructed so as to provide sufficient space to
allow each animal to turn about freely, to stand, sit, and lie in
a comfortable, normal position, and to walk in a normal manner. A
small number of commenters recommended that the wording be changed
to read "provide space that is adequate and permits freedom of
movement and normal postural adjustments." We believe that the
wording we proposed conveys the intent of the provision adequately
and we are making no changes based on these comments. One commenter
requested that we define and justify the phrase "to walk in a
normal manner." We believe that the meaning of the phrase is self-
evident and we are making no changes based on these comments.
Additional Primary Enclosure Requirements for Cats--Section
3.6(b)
We proposed to change the space requirements for cats. In
general, the proposed regulations based how much space a cat should
have on the animal's weight, and whether it is a nursing mother.
The space requirements in Secs. 3.4 (b)(1) and (b)(3) of the
existing regulations are uniform for all cats, regardless of size,
and require that each cat be given a minimum of 2.5 ft2, with room
to turn about freely, and to easily stand, sit, and lie in a
comfortable normal position. We consider it necessary, based on our
inspections of research facilities, to increase the existing
minimum space requirements for all cats. Additionally, because the
weight of a cat is a good indicator of its overall size, the floor
space requirements should distinguish between cats of different
weights. Our proposed standards would provide cats with the space
we believe is necessary, and at the same time make our regulations
correspond more closely to the NIH Guide. We proposed in Sec.
3.6(b)(1)(ii) (redesignated as Sec. 3.6(b)(1)(ii)(B) in this final
rule) to require that weaned cats weighing 8.8 lbs (4 kg) or less
be provided with at least 3.0 ft2 (0.28 m2) of floor space. We
proposed in Sec. 3.6(b)(1)(iii) (redesignated as Sec.
3.6(b)(1)(ii)(C) in this final rule) that cats weighing over 8.8
lbs (4 kg) be provided with a minimum of 4.0 ft2 (0.37m2) of floor
space. Additionally, we proposed to require that each queen with
nursing kittens be provided with an additional amount of floor
space, based on her breed and behavioral characteristics, and in
accordance with generally accepted husbandry practices as
determined by the attending veterinarian. We proposed that if the
additional amount of floor space for each nursing kitten is
equivalent to less than 5 percent of the minimum requirements for
the queen, such housing must be approved by the Committee in the
case of a research facility, and by the Administrator in the case
of dealers and exhibitors. We proposed to provide that the minimum
floor space required would be exclusive of any food or water pans,
but that the litter pan may be considered part of the floor space
if properly cleaned and sanitized. We proposed in Sec. 3.6(b)(1)(i)
(redesignated as Sec. 3.6(b)(1)(ii)(A) in this final rule) that the
height of the primary enclosure for cats would have to be at least
24 inches (60.96 cm).
A large number of commenters addressed the provisions in proposed
Sec. 3.6(b)(1) regarding minimum space requirements for cats. A
number of commenters specifically supported increased space
requirements for cats. A small number of commenters recommended
retaining the existing space requirements for cats, either in
general or based on the judgment of the attending veterinarian. A
large number of commenters recommended doubling the minimum cage
size for cats. A small number of commenters stated that all cats,
regardless of weight, should be provided with at least 4 square
feet of cage space. With regard to the height of primary
enclosures, one commenter recommended that the minimum requirement
provide only that the interior height must allow the animals to
stand and sit without touching the top. We are making no changes to
the regulations based on the comments regarding the size of primary
enclosures for cats. In developing new proposed space standards, we
have consulted extensively with HHS, as statutorily mandated. The
space requirements we proposed are consistent with other Federal
guidelines, and we consider them necessary and adequate for the
well-being of the cats. We do not agree that all cats need to be
provided with the same amount of space. It is unreasonable to
require that a cat weighing 1 lb. be provided the same amount of
space as a cat weighing 10 lbs.
A number of commenters requested that justification be provided
for the provision in proposed Sec. 3.6(b)(1)(v) (redesignated as
Sec. 3.6(b)(1)(iv) in this final rule) that food and water pans
would not be counted as required floor space. We believe it is
obvious that requiring animals to walk or rest in their food and
water receptacles in order to achieve adequate space would
encourage sanitation and health problems.
A number of commenters requested that existing primary enclosures
that would meet the proposed space requirements if the space
occupied by food and water bowls is counted, be permitted usage
until needing replacement for normal wear and tear. As discussed in
the preceding paragraph, it is not humane to require cats to use
their food and water bowls as part of their minimum floor space,
and we do not agree with the commenters' recommendation.
A number of commenters addressed the proposed requirement for
increased space for nursing queens. A small number of commenters
opposed allowing such additional space. Other commenters
recommended that the standard additional space per kitten be 10
percent, rather than 5 percent as proposed, or that the regulations
provide specific requirements for neonatal floor space, rather than
percentage requirements. We are making no changes based on these
comments. The general minimum space requirements for cats that we
proposed were found to be necessary for each animal. We consider it
self-evident that additional animals in an enclosure will occasion
the need for additional space. We disagree, however, that an
additional 10 percent is necessary for each kitten, especially in
view of the fact that this final rule will increase the minimum
space requirements for adult cats. We also disagree that specific
uniform requirements for nursing queens are appropriate. The space
necessary for the queen herself will be determined by her weight.
We consider it reasonable to base the additional space necessary
for nursing kittens on the number of kittens present.
Several commenters recommended that the requirement for
additional space for nursing queens not begin until the kittens are
3 weeks old. We disagree. Not only is the additional space
necessary from the kittens' birth, but adopting the commenters'
recommendation would often result in an unnecessary movement of the
qu
