[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

[[Page 31541]]

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