[Federal Register Volume 69, Number 108 (Friday, June 4, 2004)]
[Proposed Rules]
[Pages 31537-31541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12692]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 2 and 3
[Docket No. 98-106-4]
RIN 0579-AB69
Animal Welfare; Regulations and Standards for Birds, Rats, and
Mice
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Advance notice of proposed rulemaking and request for comments.
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SUMMARY: The Farm Security and Rural Investment Act of 2002 amended the
definition of animal in the Animal Welfare Act (AWA) by specifically
excluding birds, rats of the genus Rattus, and mice of the genus Mus,
bred for use in research. In a separate document published in the Rules
and Regulations section of today's Federal Register, we are amending
the definition of animal in our regulations to be consistent with the
definition of animal in the AWA. At this time, we are also considering
several changes to the regulations to help promote the humane handling,
care, treatment, and transportation of birds, rats, and mice not
specifically excluded from coverage under the AWA. Specifically, we
intend to extend enforcement of the AWA to birds other than birds bred
for use in research. However, before we can do so, we believe it is
necessary to consider what regulations and standards are appropriate
for them. Therefore, we are soliciting comments from the public to help
determine how we should regulate the care and use of those animals. In
addition, we are considering if we should continue to regulate the
handling, care, treatment, and transportation of rats and mice covered
by the Act under the general standards in the regulations or if we
should establish specific standards for them. To aid in that
determination, we are soliciting comments from the public
[[Page 31538]]
concerning the regulation of those animals. Finally, we are requesting
data and information from the public regarding the potential economic
effects on entities that may be affected if we were to establish
specific standards for birds, rats, and mice not specifically excluded
from coverage under the AWA.
DATES: We will consider all comments that we receive on or before
August 3, 2004.
ADDRESSES: You may submit comments by any of the following methods:
Webform: The preferred method is to use the webform
located at http://comments.aphis.usda.gov. This webform is designed to
allow commenters to associate each of their comments with the issues
identified in the advance notice, and to allow APHIS to more easily
analyze the comments received regarding each issue.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 98-106-4,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 98-106-4.
E-mail: Address your comment to
[email protected]. Your comment must be contained in the body
of your message; do not send attached files. Please include your name
and address in your message and ``Docket No. 98-106-4'' on the subject
line.
Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this
docket and submitting comments.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Jerry DePoyster, Senior Veterinary
Medical Officer, Animal Care, APHIS, 4700 River Road Unit 84,
Riverdale, MD 20737-1234; (301) 734-7586.
SUPPLEMENTARY INFORMATION:
Background
Under the Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.), the
Secretary of Agriculture is authorized to promulgate standards and
other requirements governing the humane handling, care, treatment, and
transportation of certain animals by dealers, research facilities,
exhibitors, operators of auction sales, and carriers and intermediate
handlers. Within the U.S. Department of Agriculture (USDA),
responsibility for administering the AWA has been delegated to the
Administrator of the Animal and Plant Health Inspection Service
(APHIS). Within APHIS, the responsibility for administering the AWA has
been delegated to the Deputy Administrator for Animal Care. Regulations
established under the AWA are contained in the Code of Federal
Regulations (CFR) in 9 CFR parts 1, 2, and 3. Part 1 contains
definitions for terms used in parts 2 and 3; part 2 provides
administrative requirements and sets forth institutional
responsibilities for regulated parties; and part 3 contains
specifications for the humane handling, care, treatment, and
transportation of animals covered by the AWA. Currently, part 3
consists of subparts A through E, which contain specific standards for
dogs and cats, guinea pigs and hamsters, rabbits, nonhuman primates,
and marine mammals, respectively, and subpart F, which sets forth
general standards for warmblooded animals not otherwise specified in
that part.
Definition of Animal
The Federal Laboratory Animal Welfare Act (Pub. L. 89-544),
commonly referred to as the Animal Welfare Act, was enacted in 1966 to
protect owners from pet theft, prevent use of stolen pets, and ensure
the humane treatment of research animals. Under that Act, an animal was
defined as live dogs, cats, monkeys (nonhuman primate mammals), guinea
pigs, hamsters, or rabbits. The Animal Welfare Act of 1970 (Pub. L. 91-
597) expanded the list of covered animals to include all warm-blooded
animals determined by the Secretary of Agriculture as being used, or
intended for use, in research, testing, experimentation, or exhibition,
or as a pet, and specifically excluded horses not used for research
purposes and other farm animals when used for agricultural purposes.
In 1971, USDA amended the definition of animal in Sec. 1.1 of the
regulations to incorporate the 1970 amendments to the Act and to
specifically exclude birds, rats, and mice for enforcement purposes. In
1989, USDA further amended that definition by, among other things,
narrowing the exclusion for rats and mice to only those rats of the
genus Rattus and mice of the genus Mus bred for use in research. The
AWA's definition of animal has excluded the types of rats and mice
commonly bred and used in research and all birds from coverage for over
30 years. Other types of rats and mice, such as wild rats and mice, are
covered by the regulations and standards in part 2 and subpart F of
part 3. (The regulations can be viewed on Animal Care's Internet site
at http://www.aphis.usda.gov/ac/ by selecting ``Publications''; the
regulations are listed under the heading Animal Welfare Act,
Regulations, and Standards, subheading Animal Care Regulations.)
The Farm Security and Rural Investment Act of 2002 (Pub. L. 107-
171, signed into law on May 13, 2002), included provisions that amended
the definition of animal in the AWA (7 U.S.C. 2132(g)) by specifically
excluding birds, rats of the genus Rattus, and mice of the genus Mus,
bred for use in research. While the definition of animal in the
regulations has excluded rats of the genus Rattus and mice of the genus
Mus bred for use in research, that definition has also excluded all
birds (i.e., not just those birds bred for use in research). Therefore,
in a separate document published in the Rules and Regulations section
of today's Federal Register, we are amending the definition of animal
in the regulations to be consistent with the definition of animal in
the AWA by narrowing the scope of the exclusion for birds to only those
birds bred for use in research. Our final rule is intended only to make
the definition of animal in the regulations consistent with the
definition of animal in AWA.
Advance Notice of Proposed Rulemaking
At this time, we are considering several changes to the regulations
to help promote the humane handling, care, treatment, and
transportation of birds, rats, and mice not specifically excluded from
coverage under the AWA. Specifically, we are notifying the public that
we intend to extend enforcement of the AWA to birds not bred for use in
research that are sold as pets at the wholesale level, or transported
in commerce, or used for exhibition, research, teaching, testing, or
experimentation purposes. However, before we can begin enforcing the
AWA with respect to such birds, we believe it is necessary to consider
what regulations and standards are
[[Page 31539]]
appropriate for them. Therefore, in this document, we are soliciting
comments from the public to help determine how we should regulate the
care and use of those animals. In addition, we are considering if we
should continue to regulate the handling, care, treatment, and
transportation of rats and mice covered by the AWA under the general
standards in subpart F of part 3 or if we should establish specific
standards for those animals. To aid in that determination, we are
soliciting comments from the public concerning the regulation of rats
and mice, except for rats of the genus Rattus and mice of the genus Mus
bred for use in research, that are sold as pets at the wholesale level,
or transported in commerce, or used for exhibition, research, teaching,
testing, or experimentation purposes. Finally, we are requesting data
and information from the public regarding the potential economic
effects on entities that may be affected if we were to establish
specific standards for all covered rats and mice and for birds other
than birds specifically bred for use in research.
This advance notice of proposed rulemaking is intended to help
promote the humane handling, care, treatment, and transportation of
birds, rats, and mice covered by the AWA. This action follows a notice
published in the Federal Register on January 28, 1999 (64 FR 4356-4367,
Docket No. 98-106-1) that informed the public of our receipt of a
petition for rulemaking concerning the regulation of birds, rats, and
mice, and that solicited comments from the public on that petition.
Request for Comments: Birds
Birds belong to a diverse class (Aves) of warmblooded vertebrates
characterized by having a body covered with feathers and forelimbs
modified as wings. There are approximately 9,000 species of birds
belonging to about 30 orders. Although all birds share a common origin,
birds today live in all the major biogeographic regions of the world
and are highly diverse morphologically and behaviorally, exhibiting
variation in, among other things, body and wing size and structure,
modes of locomotion, and dietary requirements. As a result of this
diversity, birds maintained in captivity often require unique husbandry
and care. For this reason, we do not believe that the general standards
in subpart F of part 3 would be appropriate or adequate to provide for
the humane handling, care, treatment, and transportation of birds.
Therefore, we are soliciting comments from the public to aid in the
development of appropriate standards for birds not specifically
excluded from coverage under the AWA. In addition, we are also
reviewing the regulations in parts 1 and 2 to determine if any changes
are necessary before we can regulate the care and use of birds not
specifically bred for use in research. Therefore, we are also
soliciting comment on certain provisions in part 2 as they pertain to
birds.
When we determine how to regulate the handling, care, treatment,
and transportation of birds other than birds bred for use in research,
we will publish a proposed rule for public comment in the Federal
Register. Any changes to our Animal Care program and regulations that
may result from such a proposal will be addressed in that document.
In particular, we invite responses to the questions listed below.
Although the following questions solicit comments concerning the
regulation of all birds not specifically excluded from coverage under
the AWA, we welcome responses that pertain to a specific type of bird.
Please make it explicit in your response if your comment addresses a
specific type of bird or if your response pertains to birds in general.
1. As mentioned above, part 3 of the regulations contains
specifications for the humane handling, care, treatment, and
transportation of animals covered by the AWA. Among other things, the
standards in part 3 address the following considerations:
Facilities and operations (including space, structure and
construction, waste disposal, heating, ventilation, lighting, and
interior surface requirements for indoor and outdoor primary enclosures
and housing facilities);
Animal health and husbandry (including requirements for
sanitation and feeding, watering, and separation and classification of
animals); and
Transportation (including specifications for primary
enclosures, primary conveyances, terminal facilities and the feeding,
watering, care, and handling of animals in transit).
Please describe minimum standards that would be appropriate for
birds other than birds bred for use in research, including requirements
for facilities and operations, animal health and husbandry, and
transportation. Please submit specific data to support any suggested
standards.
2. We are aware of several published programs of humane care and
use for birds. Should the standards we develop for birds, except for
birds bred for use in research, be consistent with any published
program(s) for the care and use of birds? If so, please submit a copy
of any suggested programs and specific data to support those standards.
3. Sections 2.1 and 2.25 of the regulations provide licensing and
registration requirements for dealers, exhibitors, operators of auction
sales, and carriers and intermediate handlers. In Sec. 2.1, paragraph
(a)(3) provides exemptions from licensing requirements for certain
entities, such as retail pet stores that sell non-dangerous, pet-type
animals, including birds, at retail only. Should we revise or add
exemptions for certain dealers, exhibitors, operators of auction sales,
and carriers and intermediate handlers of birds not bred for use in
research? If so, what should those exemptions be? Please provide
supporting data. (For example, we are aware that there are many
entities who breed small numbers of birds; if we should exempt those
entities, what criteria should we use to determine which entities
should be exempt?)
4. Currently, Sec. 2.130 provides minimum age requirements for the
commercial transportation of dogs and cats. Should we establish minimum
age requirements for the transportation of birds other than birds bred
for use in research? If so, what factors should we consider when
determining those requirements? (For example, if the animals are
weaned, the species of bird under consideration, etc.) Please provide
specific supporting data.
5. When conducting an inspection, USDA inspectors follow a given
facility's biosafety procedures or use recommended protective clothing
and equipment, such as coveralls, disposable gloves, and disposable or
sanitizable boots. We invite comments on what procedures, equipment,
and supplies should inspectors use in order to protect birds from
transmitted diseases. Should additional procedures, equipment, or
supplies be employed to inspect nesting birds? Please explain.
6. Comments are also invited concerning the number and size of
entities that may be affected if we were to regulate birds other than
birds bred for use in research. (Such entities may include dealers,
research facilities, exhibitors, operators of auction sales, and
carriers and intermediate handlers of birds not specifically bred for
use in research that are sold as pets at the wholesale level,
transported in commerce, or used for exhibition, research, teaching,
testing, or experimentation purposes.)
7. What is the number of each species of birds, except for birds
bred for use in research, that are currently sold as pets at the
wholesale level, transported in commerce, or used for exhibition,
[[Page 31540]]
research, teaching, testing, or experimentation purposes?
8. Comments are invited regarding the current physical structures,
equipment, staffing, licensing, and paperwork used in the handling,
care, treatment, and transportation of birds other than birds bred for
use in research and how those operations may be affected if we were to
extend enforcement of the AWA to those animals. In addition, if you are
submitting suggested standards for birds in response to questions 1 or
2, please address how those standards would affect facility operations.
9. What are the potential economic effects, in terms of time and/or
money, on entities that may be affected if we were to regulate birds
other than birds bred for use in research?
10. Do you have any other specific concerns or recommendations
pertaining to the regulation of birds other than birds bred for use in
research?
Request for Comments: Rats and Mice
In addition to the protections afforded by the standards and
regulations in parts 2 and 3 of the regulations, the vast majority of
animals used in biomedical research, including birds, rats, and mice,
are provided oversight by Public Health Service (PHS) of the U.S.
Department of Health and Human Services, through voluntary
accreditation by the Association for Assessment and Accreditation of
Laboratory Animal Care International (AAALAC), or both. Most biomedical
research in the United States is performed in laboratories funded at
least in part by PHS. The PHS Policy on Humane Care and Use of
Laboratory Animals covers live vertebrate animals that are involved in
activities supported by PHS. The PHS policy requires an Animal Welfare
Assurance, which is a document that commits the research institution to
a program of animal care and use that is consistent with the Guide for
the Care and Use of Laboratory Animals (referred to below as the
Guide), a publication produced by the National Research Council to
assist institutions in caring for and using animals in ways judged to
be scientifically, technically, and humanely appropriate.\1\
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\1\ The Guide can be viewed on the National Academies Press'
Internet site at http://www.nap.edu/readingroom/books/labrats/.
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In addition to PHS oversight, many U.S. research facilities are
accredited by AAALAC. This private organization, through inspections
and reviews, accredits laboratories that meet or exceed the animal care
standards in the Guide. Research facilities seek AAALAC accreditation
for assistance with public relations and in receiving grants.
While the AWA and the regulations address a broader range of
activities than does the Guide, we believe that many of the minimum
standards for the care and use of animals contained in the Guide are
applicable in research and non-research environments alike. As a
result, we have made, whenever possible, the standards in part 3
consistent with the Guide in order to eliminate confusion and to
simplify compliance for entities that must comply with both the
regulations and the Guide. In those cases where the regulations are
consistent with the Guide, it is because we have reviewed the Guide and
determined that its program for animal care and use is appropriate and
adequate to provide for the humane handling, care, treatment, and
transportation of the animals in question.
We are soliciting comments to help us determine whether we should
continue to regulate rats and mice other than rats of the genus Rattus
and mice of the genus Mus bred for use in research under the general
standards in subpart F of part 3, or if we should adopt specific
standards for those animals. While the Guide does not provide husbandry
specifications for the care and use of birds, as they are not commonly
used in biomedical research, it does provide specifications for the
care and use of rats and mice. Therefore, we also request comment on
the adequacy of the specifications in the Guide as they pertain to the
humane handling, care, treatment, and transportation of rats and mice.
If we determine that specific standards should be established for rats
and mice covered by the AWA, we will publish a proposed rule for public
comment in the Federal Register. Any changes to our Animal Care program
and regulations that may result from such a proposal will be addressed
in that document.
In particular, we invite responses to the questions listed below.
Although the following questions solicit comments concerning the
regulation of all rats and mice covered by the AWA, we welcome
responses that pertain to only rats or to mice, or to a specific type
of rat or mouse. Please make it explicit in your response if your
comment addresses a specific type of animal or if your response
pertains to rats and mice in general.
11. Should rats and/or mice other than rats of the genus Rattus and
mice of the genus Mus bred for use in research continue to be regulated
under the general standards in subpart F of part 3? If so, please
submit any data available to support the continued regulation of those
animals under that subpart.
12. As mentioned above, part 3 contains specifications for the
humane handling, care, treatment, and transportation of animals covered
by the AWA. Among other things, the standards in part 3 address the
following considerations:
Facilities and operations (including space, structure and
construction, waste disposal, heating, ventilation, lighting, and
interior surface requirements for indoor and outdoor primary enclosures
and housing facilities);
Animal health and husbandry (including requirements for
sanitation and feeding, watering, and separation and classification of
animals); and
Transportation (including specifications for primary
enclosures, primary conveyances, terminal facilities and the feeding,
watering, care, and handling of animals in transit).
Should specific standards be developed for rats and/or mice other
than rats of the genus Rattus and mice of the genus Mus bred for use in
research? If so, what minimum standards would be appropriate for those
animals, including requirements for facilities and operations, animal
health and husbandry, and transportation? Please submit specific data
to support any suggested standards.
13. As noted above, research institutions funded at least in part
by the Public Health Service of the U.S. Department of Health and Human
Services are required to follow a program of animal care and use that
is consistent with the National Research Council's Guide for the Care
and Use of Laboratory Animals. To eliminate confusion and simplify
compliance for entities that must comply with the regulations and the
Guide, we have, whenever possible, made the standards in part 3 of the
regulations consistent with the program of animal care and use in the
Guide. If specific standards should be developed for rats and mice
other than rats of the genus Rattus and mice of the genus Mus bred for
use in research, are the specifications for the care and use of rats
and mice contained in the Guide appropriate and adequate to provide for
the humane care, handling, treatment, and transportation of those
animals? If so, please submit specific data to support the adoption of
the Guide's specifications for rats and mice.
14. Comments are invited concerning the number and size of entities
that use rats and mice, except for rats of the genus Rattus and mice of
the genus Mus
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bred for use in research, for purposes covered by the AWA. (Such
entities may include dealers, research facilities, exhibitors,
operators of auction sales, and carriers and intermediate handlers of
rats and mice covered by the AWA that are sold as pets at the wholesale
level, transported in commerce, used in exhibits, or used for research,
teaching, testing, or experimentation purposes.)
15. What is the number of each species of rats and mice, except for
rats of the genus Rattus and mice of the genus Mus bred for use in
research, that are currently sold as pets at the wholesale level,
transported in commerce, used in exhibits, or used for research,
teaching, testing, or experimentation purposes?
16. Comments are invited concerning the current physical
structures, equipment, staffing, licensing, and paperwork used in the
handling, care, treatment, and transportation of rats and mice, except
for rats of the genus Rattus and mice of the genus Mus bred for use in
research, for purposes covered by the AWA. If you are submitting
suggested standards for rats and mice in response to question 12 or
believe that we should establish specific standards for covered rats
and mice that are consistent with the Guide (see question 13, above),
please address how those standards would affect facility operations.
17. What are the potential economic effects, in terms of time and/
or money, on entities that may be affected if we were to establish
specific standards for rats and mice covered by the AWA? (Such entities
may include dealers, research facilities, exhibitors, operators of
auction sales, and carriers and intermediate handlers of rats and mice
covered by the AWA that are sold as pets at the wholesale level,
transported in commerce, used in exhibits, or used for research,
teaching, testing, experimentation, or exhibition purposes.)
18. Do you have any other specific concerns or recommendations
pertaining to the regulation of rats and mice other than rats of the
genus Rattus and mice of the genus Mus bred for use in research?
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
Done in Washington, DC, this 1st day of June 2004.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 04-12692 Filed 6-3-04; 8:45 am]
BILLING CODE 3410-34-P