Glossary of Terms

Airport inspection—Individual airline inspections of cargo
and baggage areas made at airports for compliance with
the AWA regulations and standards.

Alleged violation—A violation of the AWA regulations or
standards that has been documented as existing but has
not been legally concluded.

Carrier—The operator of any airline, railroad, motor
carrier, shipping line, or other enterprise that is engaged
in the business of transporting any animals for hire.

Commerce—Trade, traffic, or transportation that is
between a place in a State and any place outside of such
State (including foreign countries), or between points
within the same State but through any place outside of the
State.

Complaints—{1) A civil or administrative complaint
informs the alleged violator of the AWA about allegations
charged against hinVher. (2) A public complaint is
information received from citizens, humane groups, or
others concerning possible violations of the AWA,
regulations, or standards at animal facilities.

Compliance—the status of a facility that meets all of the
regulatory requirements set forth in the AWA regulations
and standards.

Dealer—Any person who, in commerce, for compensation
or profit, delivers for transportation, or transports (except
as a carrier), buys, or sells, or negotiates the purchase or

- sale of (1) any dog or other animal whether alive or dead
(including unborn animals, organs, limbs, blood, serum, or
other parts) for research, teaching, testing, experimen-
tation, exhibition, or for use as a pet; or (2) any dog for
hunting, security, or breeding purposes. The term dealer
does not include a retail pet store unless such store sells
any animals to a research facility, an exhibitor, or toa
dealer (wholesale); or any person who does not sell, or
negotiate the purchase or sale, of any wild or exotic
animal, dog, or cat and who derives no more than $500
gross income from the sale of animals, dogs, or cats,
during any calendar year.

Enforcement—The activities undertaken by USDA and
APHIS/AC and IES personnel to ensure that the AWA’s
regulations and standards are met. Enforcement includes
developing alleged violation cases and taking action in the
form of Letters of Warning, warning tickets, stipulations,
administrative complaints, hearings, trials, and other legal
procedures and methods to obtain compliance.

18

Exhibitor—Any person (public or private) exhibiting any
animals which were purchased in,commerce or the
intended distribution of which affects commerce, or will
affect commerce, to the public for compensation.
Exhibitors include carnivals, circuses, animal acts, Zoos,
and educational exhibits, whether exhibiting for profit or
not. The term exhibitor excludes most retail pet stores,
horse and dog races, organizations sponsoring, and all
persons participating in State and county fairs, livestock
shows, rodeos, field trials, coursing events, purebred dog
and cat shows, and any other fairs or exhibitions intended
to advance agricultural arts and sciences.

Facility—A facility is the holder of the license or
registration. Each facility may have only one license or
registration number but may be physically divided into two
or more sites.

Inspections—

* Attempted inspection—An inspection that could not be
completed, including those where representatives of the
inspected entities were not onsite or transportation
facilities were found to have no animals present.

.

Compliance inspection—An unannounced inspection
completed, after licensing or registration, to determine
the facility's compliance with the AWA regulations and
standards. Compliance inspections include
reinspections.

Prelicensing or Preregistration inspection—An
announced inspection made, after application for
licensure or registration has been submitted, to
ascertain compliance with the AWA regulations and
standards prior to licensing or registering the facility.
Prelicensing inspections are required. Preregistration
inspections, although not required, are often performed
upon request of the facility.

Reinspection—An inspection made following a
compliance inspection in which one or more violations
were documented.

Intermediate handler—Any person who is engaged in any
business receiving custody of animais in connection with
their transportation in commerce. This definition excludes
dealers, research facilities, exhibitors, operators of auction
sales, and carriers.

Investigation—nquiries and examination of allegation(s)
that a person or facility is not complying with the AWA or
its regulations or standards.


Licensed Dealers

Dealers—defined as persons selling regulated animals for
research or teaching; wild or exotic animals in retail
channels for exhibition, or for pets; or domestic pet
animals at the wholesale level—must be licensed by
APHIS/AC. There are two classes of dealer licensees.
The Class A licensees are breeders dealing only in
animals that they breed and raise. The Class B licensees
include brokers, operators of auction sales, and
“punchers.” In FY 1996, there were 2,976 licensed A
dealers (with a total of 3,043 sites) and 1,099 licensed B
dealers (with a total of 1,222 sites). Of the 1,099 Class B
dealers, APHIS estimates that there are fewer than 40
supplying animals to research.

The numbers of Class A and B licensed dealers and sites
for FY 1994 through 1996 are listed in the next tabulation.

Chart 7

The number of compliance inspections for dealers during
the same period is shown on chart 7.

Licensed Dealers, FY 1994-96

Total Class A
dealers dealers
FY (sites) (sites)

Class B
dealers
(sites)

1996 4,075 2,976 1,099
(4,265) (3,043) (1,222)

1995 4,080 2,967 1,113
(4,325) (3,056) (1,269)

1994 4,238 NA

NA
(4,556) (3,230) (1,326)

A and B Dealers

FY 1994-96

8,000 (1994
7,000 HB 1995
6,000
5,000

4,238
4,000 4,080 4,075

3,000
2,000

1,000

6,418
5,854 5,819

Number of facilities

Numbers from Work-Based Budget System (WBBS) reports

Total sites

Total inspections

12


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Legislative History

In 1966, Congress enacted Public Law (P.L.) 89-544,
known as the Laboratory Animal Welfare Act. This law
regulated dealers who handle dogs and cats as well as
laboratories that use dogs, cats, hamsters, guinea pigs,
rabbits, and nonhuman primates in research.

The first amendment to the Laboratory Animal Welfare
Act was passed in 1970 (P.L. 91-579) and changed the
name of the law to the Animal Welfare Act (AWA). This
amendment authorized the Secretary of Agriculture to
regulate other warmblooded animals when used in
research, exhibition, or the wholesale pet trade.

An amendment in 1976 (P.L. 94-279) prohibited most
animal fighting ventures and regulated the commercial
transportation of animals. Another amendment was
added to the AWA in 1985 as the Improved Standards for
Laboratory Animals Act, which was part of the Food
Security Act. These amendments required the Secretary
to issue additional standards for the use of animals in
research.

In 1990, provisions concerning injunctive relief and pet
protection were added to the AWA. These two provisions
were included in the Food, Agriculture, Conservation and
Trade Act of 1990. The injunctive relief provision
authorizes the Secretary to seek an injunction to stop
certain licensed entities from continuing to violate the
AWA while charges are pending. (Injunctions are used in
cases of stolen animals and where an animal's health is in
serious danger or may become endangered.) The pet
protection provision mandated that the Secretary issue
additional regulations pertaining to random-source dogs
and cats. (Random source means “dogs and cats
obtained from animal pounds or shelters, auction sales, or
from any person who did not breed and raise them on his
or her premises.”)

Regulations

With regard to animals used in research, the Improved
Standards for Laboratory Animals Act required the
Secretary of Agriculture to promulgate standards for the
exercise of dogs and for a physical environment adequate
to promote the psychological well-being of nonhuman
primates. Additional requirements of the 1985
amendments included the establishment of Institutional
Animal Care and Use Committees at research facilities;
standards to ensure that pain and distress are minimized,
and that anesthetics, analgesics, and tranquilizers are
used appropriately; and standards that require a
researcher to consider alternatives to painful procedures.
In order to implement the Improved Standards for
Laboratory Animals Act, the final regulations for parts 1
and 2 of Title 9, Code of Federal Regulations (CFR),
Chapter 1, Subchapter A, were published on August 31,
1989; those for Part 3 were published on February 15,
1991.

Revised standards for guinea pigs, hamsters, and rabbits
were published in final form in the Federal Register on
July 15, 1990, and became effective on August 15, 1990.
These standards increased the minimum space
requirements and provided additional requirements to
protect animals being transported via common carrier.

On April 5, 1990, the U.S. Department of Agriculture's
(USDA) APHIS published a notice in the Federal Register
Of its intent to regulate horses used for biomedical or other
nonagricultural research, and other farm animals used for
biomedical or other nonagricultural research or for
nonagricultural exhibition. The final rule became effective
on June 4, 1990. Until specific regulations can be
promulgated, the standards in Title 9, CFR, Chapter 1,
Subchapter A, Part 3, Subpart F, for “other warmblooded
animals” will be applied.

The Pet Protection Act, which was passed in November
1990 by Congress as part of the Food, Agriculture,
Conservation and Trade Act of 1990, sets specific holding
periods for animals in public or private pounds or shelters
and requires certification that the holding period has been
met. The regulations for this Act, proposed on November
15, 1991, were published as a final rule on July 22, 1993,
and became effective August 23, 1993.


License classes—There are three categories of licensees,
Class A, Class B, and Class C.

+ A Class A licensee is anyone meeting the definition of
“dealer” whose business consists only of animals that
are bred and raised on the premises in a closed or
stable colony and those animals acquired for the sole
purpose of maintaining or enhancing the breeding
colony.

* A Class B licensee is anyone meeting the definition of a
“dealer” whose business includes the purchase and/or
resale of any animal. Class B licensees include brokers
and operators of auction sales, as such individuals
negotiate or arrange for the purchase, sale, or transport
of animals in commerce.

* A Class C licensee is anyone meeting the definition of
an “exhibitor” whose business involves the showing or
displaying of animals to the public.

Random source dogs and cats—Animals acquired from
animal pounds and shelters, auction sales, or from any
person who did not breed and raise the animals on his or
her premises.

Registrant—Any research facility, carrier, intermediate
handler, or exhibitor whose primary business is not
required to be licensed by the AWA. If a registered facility
conducts an activity that requires a license, then it will
also be licensed for that activity. For example, some
research facilities have a dealer license in addition to their
registration because they occasionally sell surplus
animals to other research facilities.

Research facility—Any school (other than elementary or
secondary), institution, organization, or person that uses
or intends to use live animals in research, tests, or
experiments, and that; (1) purchases or transports live
animals in commerce or, (2) receives funds under a grant,
award, loan, or contract from a department, agency, or
instrumentality of the United States for the purpose of
carrying out research, tests, or experiments.

* An active registered research facility is a USDA-
registered research facility that currently utilizes animals
covered by the AWA for teaching, testing, or
experimentation.

¢ An inactive registered research facility is a USDA-
registered research facility that currently does not utilize
animals covered by the AWA for teaching, testing, or
experimentation.

Retail pet store—Any outlet where only the following
animals are sold or offered for sale, at retail, for use as
pets: dogs, cats, rabbits, guinea pigs, hamsters, gerbils,
tats, mice, gophers, chinchillas, domestic ferrets,
domestic farm animals, birds, coldblooded species, and
other common small pets. Retail pet stores do not include
any establishment or persons who (1) deal in dogs used
for hunting, security, or breeding purposes; (2) exhibit,
sell, or offer to exhibit or sell, any wild or exotic or other
nonpet species of warmblooded animals (except birds)
such as skunks, raccoons, nonhuman primates, squirrels,
ocelots, foxes, coyotes, etc.; (3) sell warmblooded
animals (except birds and laboratory rats and mice) for
research or exhibition purposes; (4) wholesale any
animals (except birds and laboratory rats and mice); or
(5) exhibit pet animals in a room that is separate from or
adjacent to the retail pet store, or in an outside area, or
anywhere off the retail pet store premises.

Search—Activity associated with finding unlicensed or
unregistered entities.

Site—The physical location where animals are used,
housed, or maintained by a licensed or registered facility.
A licensed or registered facility may have one or more
animal sites. A site may be a room, building, outdoor run
area, or similar type of facility used to hold or work on
animals.

Stipulation—An agreement by a violator to accept
assessment of a civil penalty, license suspension, or
combination of both. The stipulation procedure is used
instead of formal administrative hearings. Alleged
violators are offered the opportunity to waive a hearing by
agreeing to enter into a stipulation, in which case they will
pay a specified civil penalty and/or have their license
suspended for a specified period.

Violation—An area or item, at a registered or licensed

facility, found to be out of compliance with the regulations
or standards of the AWA.

19


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21


APHIS’ AC personnel actively participate with
organizations concerned about the humane care of
animals. AC maintains an active role with such
organizations as the American Zoo and Aquarium
Association, the National Association for Biological
Research, Americans for Medical Progress, the American
Association of Zoo Veterinarians, the Alliance for Marine
Mammal Parks and Aquariums, the American Association
for Accreditation of Laboratory Animal Care, the
Scientist's Center for Animal Welfare, the Humane
Society of the United States, the Animal Welfare Institute,
the American Humane Association, the Animal Protection
Institute, the Association of American Medical Colleges,
and the Air Transport Association. AC is also represented
in the U.S. Animal Health Association and has members
on both its animal welfare and zoological committees. AC
personnel are often invited by Federal agencies and
Nongovernmental organizations to give presentations
concerning animal welfare.

A joint project between USDA, the Federal Aviation
Administration (FAA), and the carrier industry, begun in
1992, was completed in FY 1996. The purpose of this
project is to measure environmental conditions in airplane
cargo areas used for the transportation of animals. The
report from this project will be published after necessary
clearances through the FAA.

During the past year, AC personnel in the four regional
Offices attended and/or conducted at least 447 meetings
with industry, animal welfare groups, and officials from
other government agencies.

In FY 1996, AC regional personnel published two papers
in the “Synapse,” a newsletter of the American Society of
Laboratory Animal Practitioners. The purpose of these
publications was to inform the research industry of AC's
regulations, standards, policies, and program activities.
AC also helps Lab Animal Magazine publish informational
material about the AWA and its enforcement.

16

Public Information

APHIS issued 81 press releases concerning animal
welfare during FY 1996. In 72 of these releases, there
was information concerning 53 actions taken (such as
settlements, fines, suspensions, and confiscations) and
38 charges of violations. The other nine releases
concemed matters such as announcements of public
forums on commercial dog and cat breeders and on
marine mammal negotiated rulemaking. AC personnel
also gave numerous local and national television, radio,
and newspaper interviews on various issues relating to
the AWA.

Informational material published during FY 1996 included
last year’s version of this report, the Strategic Plan for AC,
List of Licensed Dealers, List of Licensed Exhibitors, List
of Registered Exhibitors, List of Registered Research
Facilities, List of Registered Carriers and Intermediate
Handlers, a factsheet explaining the mission of AC, and a
brochure on the AC customer service plan.

Also, in FY 1996, AC made its debut in cyberspace with
its own page on the World Wide Web. This site (located
at http:/Avww.aphis.usda.gov/ac) not only contains
information concerning AC’s mission but also includes a
“Missing Animal Page’ that is popular with the media and
the public. Most of AC’s publications are also found on
this web site.

Public Correspondence

During FY 1996, APHIS received and responded to
thousands of inquiries about animal welfare from
individual citizens, concerned groups, the Office of the
President, and Members of Congress. Other Federal
agencies also refer animal welfare concerns to APHIS for
appropriate responses. Listed in the next tabulation are
the numbers of animal welfare inquiries received by
APHIS during FY 1994 through 1996.

Animal Welfare Correspondence Received by APHIS,
FY 1994-96

Correspondence Correspondence
received/dispatched received/dispatched
FY by headquarters by sector offices
1996 6,155 37,736
1995 5,853 28,162
1994 6,594 7,403



Reports From Research Facilities

Each research facility registered under the AWA and each
Federal research facility is required to submit an annual
report, signed and certified by the Institutional Official,
covering the previous fiscal year. The report lists the
number and species of animals used in research, testing,
and experimentation, and indicates whether pain- or
distress-relieving drugs were administered. If such drugs
were not administered, the report must explain why their
use would have interfered with the research or
experiment. The report must also assure that
professionally acceptable standards, including the
appropriate use of pain- or distress-relieving drugs, were

Chart 3

followed; that each principal investigator considered
alternatives to painful or distress-causing procedures;
and that the facility adhered to the regulations under the
AWA and that any exception to such adherence was
justified by the principal investigator and approved by the
Institutional Animal Care and Use Committee.

In FY 1996, 1,345,739 warmblooded animals were used
in research, testing, or experimentation by USDA-
registered and Federal research facilities. This number
excludes birds, laboratory rats and mice, and farm
animals used exclusively in agricultural research. Chart 3

Testing, and Teaching
FY 1996

1,500,000

1,000,000

500,000

299,011

82,454
26,035

Dogs Cats

Primates Guinea
pigs

LARIS recorded numbers from APHIS form 7023

Hamsters Rabbits Sheep

Animals Used in Research, Experiments,

1,345,739

Pigs Other Other_—Total



AC Headquarters Office:

U.S. Department of Agriculture

Animal and Plant Health Inspection Service
Animal Care

4700 River Road, Unit 84

Riverdale, MD 20737-1234

(301) 734-7833

Eastern AC Regional Office:

Connecticut, Delaware, District of Columbia, Illinois,
Indiana, Maine, Maryland, Massachusetts, Michigan,
Minnesota, New Hampshire, New Jersey, New York,
Ohio, Pennsyivania, Rhode Island, Vermont, Virginia,
West Virginia, Wisconsin

USDA, APHIS, AC

Regional Director

2568-A Riva Road, Suite 302
Annapolis, MD 21401-7400
(410) 571-8692

Central AC Regional Office:

Arkansas, lowa, Kansas, Louisiana, Missouri, Nebraska,
North Dakota, Oklahoma, South Dakota, Texas

USDA, APHIS, AC

Regional Director

501 Felix Street, Building 11
P.O. Box 6258 .
Fort Worth, TX 76115

(817) 885-6923

Southeast AC Regional Office:

Alabama, Florida, Georgia, Kentucky, Mississippi, North
Carolina, Puerto Rico, South Carolina, Tennessee, Virgin
Islands

USDA, APHIS, AC

Regional Director

501 East Polk Street, Suite 820
Tampa, FL 33602

(813) 225-7693

Western AC Regional Office:

Alaska, Arizona, California, Colorado, Hawaii, Idaho,
Montana, Nevada, New Mexico, Oregon, Utah,
Washington, Wyoming

USDA, APHIS, AC

Regional Director

9580 Micron Avenue, Suite J
Sacramento, CA 95827
(916) 857-6205

Animal Welfare Information Center:

AWIC Coordinator

National Agricultural Library

10301 Baltimore Avenue

Beltsville, MD 20705

(301) 504-6212

E-mail: awic@nal.usda.gov

Website: http:/Awww.nal.usda.gov/awic

USDA's Voice Response Service:
(800) 545-USDA (-8732)

This menu-driven phone system has some animal care
requirements on the subjects of transportation,
recordkeeping, and identification.

AC on the Internet

To access AC’s home page on the Internet, point your
Web browser to http:/(www.aphis.usda.gov/ac and hit
Enter.

Address e-mail correspondence to
jdepoyster @ aphis.usda.gov if you wish to correspond
with AC via the Internet.

31


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Appropriations for FY 1996

The FY 1996 Animal Welfare program was appropriated
$9,185,000 for activities related to animal welfare. The
tabulation below indicates APHIS’ animal-welfare-related
appropriations for FY 1996 and the preceding 2 fiscal
years.

Appropriations for Animal Welfare, FY 1994-96

Annual appropriation

for enforcement of the
FY Animal Welfare Act
1996 $9,185,000
1995 $9,262,000
1994 $9,262,000

Organization and Administration
of the AWA

USDA is charged with developing and implementing
regulations to support the AWA. These regulations, which
appear in Title 9, CFR, Chapter 1, Subchapter A, Parts 1-
3, provide minimum standards for the care and handling
of covered animals. Included are requirements for
handling, housing, feeding, sanitation, ventilation, shelter
from extreme weather, veterinary care, and separation of
species when necessary. Birds and laboratory rats and
mice are not currently included in the regulations.

Within USDA, APHIS is responsible for administering the
AWA. The AC unit of APHIS, created in 1988, has direct
responsibility to administer and enforce the AWA and the
Horse Protection Act.

By maintaining a separate component for animal care,
APHIS has provided a means for the AC program to
benefit from its visibility and unique position. AC
employees are highly qualified and have an excellent
professional support system and communication network.
All of these individuals are well trained, and many have
specialized interest and expertise in such areas as the
care of laboratory animals, zoo animals, and marine
mammals.

Investigative and Enforcement Services' (IES) personnel
provide investigatory services across all APHIS programs
with the unified goal of enhancing compliance with agency
regulations.

APHIS/AC and IES Headquarters Activities

The Assistant Deputy Administrator for AC supervises the
field inspection force. The AC staff provides technical
support and assists in developing program direction,
goals, priorities, policies, procedures, and regulations to
carry out the AC program effectively and efficiently. The
AC staff serves as a primary source of the agency's
expertise in the areas of laboratory animals and research
facilities, horse protection, exhibition animals,
transportation of regulated animals, and animal dealers.

In cooperation with APHIS’ Organizational and
Professional Development group, the AC staff provides
program training for AC personnel. The staff also
cooperates with other Federal agencies in enforcing the
AWA and in maintaining liaison and working relations with
regulated professional groups, industry organizations,
humane groups, the scientific community, and other
concemed associations or individuals.

‘At the beginning of FY 1997, APHIS” Regulatory Enforcement and Animal
Care unit was reorganized. AC and Regulatory nforcement staffs are no
longer in the same administrative unit. AC is a unit by itself, and Regulatory
Enforcement, now known as Investigative and Enforcement Services, is part
of another unit.


In FY 1994, two important legal decisions affected
USDA's regulations. On May 20, 1994, the U.S. Court of
Appeals for the District of Columbia Circuit reversed an
earlier order by the U.S. District Court (January 8, 1992)
that ordered USDA to cover rats, mice, and birds under
the AWA regulations. Under the Secretary of
Agriculture’s discretionary authority, common rats and
mice bred for laboratory use and birds are not currently
regulated. The Appeals Court opinion said that the
plaintiffs lacked the legal standing to sue and the statutory
right to judicial review under the Administrative
Procedures Act.

In another ruling, on July 22, 1994, the U.S. Court of
Appeals reversed an earlier order by the U.S. District
Court, dated February 25, 1993, that would have
invalidated USDA's performance-based regulations
concerning exercise for dogs and the psychological well-
being of primates. The Appeals Court opinion said that
the plaintiffs lacked the legal standing to bring suit against
the Government; therefore, the Court did not have
jurisdiction to rule.

A revision of portions of Title 9, CFR, Subchapter A,
Part 2 pertaining to licensing and renewal was published
as a final rule in FY 1995.

Animal Care’s Strategic Direction

In April 1996, AC published a document entitled Strategic
Direction for the Animal Care Program. It was initiated to
evaluate the current ways AC functions and make
recommendations for improvement. The recommenda-
tions cover such areas as statutory and regulatory
authority, the AWA inspection system, enforcement
activities, educational efforts to improve compliance,
employee needs, and innovative use of resources. In
crafting AC’s new strategic direction, the agency's
Strategic Direction Team agreed on the following
objectives:

* Enhance statutory, regulatory and procedural
authorities.

* Provide proactive leadership in establishing acceptable
practices of animal care and treatment.

* Maximize resources for enhanced program delivery and
efficiency.

* Respond to external concerns and expectations through
objective action.

* Empower, support, and develop employees.

One of the recommendations of the Strategic Direction
Team was to establish an Initiatives Coordinator position
whose total responsibility would be to coordinate all the
change activities. This position was filled in June 1996.
Nine field teams were selected; by the end of FY 1996,
four of these teams had held formal meetings.

The Program Results Monitoring Team developed criteria
so AC can measure its accomplishments. Among these
are (1) analyzing information in our Licensee Application
and Registrant Information System (LARIS) data base to
obtain the level of compliance of facilities on their last full
inspection; (2) analyzing LARIS data to show the number
of animals affected by the violations of the AWA; and

(8) analyzing compliance and tracking information system
data to show the timeliness of adjudication.

The Regulation, Act and Policy Team established
procedures to obtain field input for statuary, regulatory,
and policy change. They also finalized the new AC
policies that will be published in 1997.


Freedom of Information Act (FOIA)
Requests

In FY 1996, APHIS received 403 FOIA requests related to
animal welfare. The following tabulation lists the numbers
of such requests received for the past 3 fiscal years.

Animal-Welfare-Related FOIA Requests Received by
APHIS, FY 1994-96

FOIA
FY requests
1996 403
1995 507
1994 486

Legislative and Regulatory
Recommendations

There were no legislative recommendations or proposals
issued by AC in FY 1996. Several regulatory proposals
and changes were initiated during FY 1996:

The negotiated rulemaking process to revise Title 9
CFR, Chapter 1, Subchapter A, Part 3, Subpart E
(Marine Mammal Captive Care and Maintenance) was
completed.

Further progress was made on the “Swim-with-the-
Dolphins” regulations.

* Adocket changing Title 9 CFR, Chapter 1, Subchapter
A, Part 3, Subpart F to add perimeter fence
requirements for exhibitors and exotic animal dealers
entered the clearance channels.

¢ Arecommendation to change Title 9 CFR, Chapter 1,
Subchapter A, Part 3, Subpart F to add requirements for
handling and training of dangerous animals was initiated
at the staff level.

* A recommendation from staff was made to alter Title 9
CFR, Chapter 1, Subchapter A, Part 3, Subpart F to add
minimum age requirements for transportation of exotic
or wild animals.

¢ A recommendation from staff was made to expand
space requirements of Title 9 CFR, Chapter 1,
Subchapter A, Part 3, Subpart F, especially those of
traveling exhibitors.

* There were several proposals related to animal dealers

and exhibitors which would modify the standards in Title
9 CFR, Chapter 1, Subchapter A, Part 3, Subpart A.

17


Licensing and Registration

The AWA regulations require the licensing of animal
dealers, exhibitors, and operators of animal auction sales
where animals regulated under the AWA are sold.
Licenses are valid unless the licensee terminates the
license voluntarily or fails to renew it, or an administrative
law judge suspends or revokes the license in an
enforcement proceeding. The Department terminates
licenses that are not renewed within the time
requirements set forth in the regulations. Following the
investigation of an alleged violation, a license may be
revoked or suspended by an administrative law judge
after notice and opportunity for a hearing. Licensing fees
for dealers and exhibitors are determined by a graduated
schedule listed in the regulations [9 CFR 2.6(5)(c)].
Dealers pay between $30 and $750, and exhibitors pay
between $30 and $300 per year. These fees are
deposited as “miscellaneous receipts” in the U.S.
Treasury.

The AWA also requires all carriers, intermediate handlers,
exhibitors not subject to licensing, and non-Federal
research facilities to register with the Secretary of
Agriculture. There is no charge to register.

Chart 2

Research Facilities

Research facilities that use animals include hospitals,
colleges and universities, diagnostic laboratories, and
many private firms in the pharmaceutical and
biotechnology industries.

All research facilities are required to comply with the
AWA's regulations. Even though Federal facilities are not
registered or inspected under the AWA, they are
responsible for maintaining compliance with the AWA's
regulations and standards. The AWA requires that non-
Federal research facilities receive at least one
unannounced inspection per year to determine
compliance. Listed below are the number of research
facilities and sites for FY 1994 through 1996. In FY 1996,
there were 1,264 research facilities with a total of 2,506
sites. Chart 2 shows the number of inspections of
research facilities for FY 1994 through 1996.

Registered Research Facilities and Sites, FY 1994-96

Total Total
FY facilities sites
1996 1,264 2,506
1995 1,200 2,688
1994 1,380 2,992

and Inspections

FY 1994-96
4,000

(1994

HB 19905
3,000 Hl i996 2,992
2,000

1,380 4300 1,264
1,000
t)

Number of facilities

Numbers from Work-Based Budget System (WBBS) reports

Registered Research Facilities, Total Sites,

Total sites



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23


USDA

United States
Department of
Agriculture

Animal and
Plant Health

Inspection
Service

APHIS 41-35-049

Animal Welfare
Enforcement

Fiscal Year 1996

Report of the Secretary of Agriculture
to the President of the Senate and the
Speaker of the House of Representatives

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Animal Exhibitors

Regulated Exhibitors, FY 1994-96

Exhibitors

Licensed exhibitors operate animal acts, camivals, Total ; ;
circuses, public zoos, “roadside zoos,” and marine exhibitors Licensed Registered
mammal displays. Most of the animals exhibited are FY (sites) (sites) (sites)
species not native to the United States (e.g., nonhuman
primates, hoof stock, carnivores, and wild rodents), but
exhibited species may also include domestic farm animals 1996 2,098 2.073 bs
and wild animals native to this country. During FY 1996, (2,453) (2,422) 61)
there were 2,073 licensed exhibitors (with a total of 2,422
sites) and 25 registered exhibitors (with a total of 31 1995 Beets 2 soe os
sites). Licensed exhibitors are those entities that either (2,389) (2,304) (35)
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for compensation. Registered exhibitors do not buy, sell, 1994 pees bey ne
or transport animals and do not accept compensation. (2,268) (1,861) (NA)
Listed below are the number of exhibitors and sites
regulated during FY 1994 through 1996. Chart 5 shows
the number of inspections for that same period. :
Chart 5
Exhibitors
FY 1994-96
4,000
(1994 3,274

3,000 i 1995 3,083

2,000

1,000

10)

Numbers from Work-Based Budget System (WBBS) reports

Number of facilities Total sites

Inspections

10


shows the number and species of animals used in
research for FY 1996. Chart 4 shows the number of
animals used in research that involved no pain or distress,
or that involved pain or distress alleviated with drugs, or
that involved pain or distress without relief because use of
pain- or distress-relieving drugs would interfere with the
results of the research or testing. Tables 1 through 5 of
the appendix contain further details. Table 6 reports the
total of animals used by research since the first published
report in 1973.

In FY 1996, there were 35 research facilities (16 non-
Federal and 19 Federal) whose data are not included in
this report because they either did not submit a report or
submitted it too late for tabulation. It is a violation of the
AWA for a facility, whether active or inactive, not to submit
a timely report. AC initiated the appropriate corrective
actions.

Chart 4
Animals Experiencing Pain and/or Distress,
Pain/Distress Relief, or No Pain/Distress
During Experiments
FY 1996
1,500,000
1,345,739
1,000,000
717,399
500,000 470,976
157,364
Oo
Pain and/or Pain and/or No pain Total animals
distress with distress and/or used in
no drugs alleviated distress research
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The IES staff, the investigative arm of APHIS, ensures
compliance with APHIS regulations concerning plants and
animals. Compliance with APHIS’ regulations is
accomplished through strong educational efforts, sound
enforcement, and comprehensive investigations.

IES works closely with USDA's Office of the General
Counsel and other Federal agencies, State and local
governments, and industry groups. IES’ primary clients
within APHIS are AC, Center for Veterinary Biologics,
Plant Protection and Quarantine, and Veterinary Services.

APHIS/AC and IES Field Activities

Through the end of FY 1996, the AC program was
administered through regional offices in Annapolis, MD,
Tampa, FL, Sacramento, CA, and Fort Worth, TX. Each
regional office is responsible for administering the AWA in
the specific States within its jurisdiction. Based in each
Office is a regional director who manages the AC
program. Licensing, registration, and investigation of
complaints and alleged violations are accomplished by
administrative, technical, and clerical employees also
based at the regional offices. The AC field force consists
of veterinary medical officers and animal care inspectors.
It should be noted that, due to the Federal Government's
reorganization initiative, AC eventually plans to merge
these four regional offices into two.

IES is administered through regional offices in Annapolis
and Fort Worth. Based in each regional office is a
regional director who manages the IES program. IES
field personnel investigate alleged compliance violations
across all APHIS’ line program areas.

Animal Welfare Information Center

The Animal Welfare Information Center (AWIC) is part of
the National Agricultural Library (NAL) at Beltsville, MD.
The Center was established in December 1986, as
mandated by the 1985 Improved Standards for
Laboratory Animals Act. AWIC is specifically directed
to provide information concerning (1) methods of
humane animal care and use, (2) alternatives to the
use of live animals in research, (3) methods to
minimize pain and distress to animals, (4) possible
duplication of research involving animals, (5) materials
for the training of personnel, and (6) other topics that
‘support the administration and regulatory requirements of
the AWA.

In FY 1996, AWIC staff responded to about 16,645
requests for reference services and specific publications,
including copies of the AWIC Newsletter. About 12,000
Internet users accessed AWIC materials at the Center's
web site address at http://www.nal.usda.gov/awic. More
than 37,000 publications, including a 5-volume set of
electronic documents, were distributed. The quarterly
AWIC Newsletter continues to be sent to about 6,000
requestors in the United States and 38 foreign countries.

In FY 1996, 258 individuals attended an AWIC workshop
entitled “Meeting the information Requirements of the
Animal Welfare Act,” which was held at the NAL and at
other locations throughout the country. Presentations
about AWIC and the Animal Welfare program were given
to just under 1,300 people at various universities,
conferences, and professional meetings.

Also in FY 1996, an Italian public television show filmed
AWIC staff performing a data-base search for alternatives
to animal use. The program aired on a special segment
devoted to alternatives in testing and research.

AWIC participated with APHIS AC staff in planning and
organizing a symposium to mark the 30th anniversary of
the AWA. About 200 people attended. AWIC will publish
the proceedings of the meeting.

AWIC staff also coordinated the development of a computer
CD ROM disk that contains many official documents
related to animal welfare (such as the AWA itself and the
National Institutes of Health’s Guide for the Care and Use
of Laboratory Animals). This project was funded by
APHIS’ AC, the U.S. Department of Health and Human
Services’ Public Health Service and National Institutes of
Health, and NAL. This CD ROM can be purchased for
$35 by contacting the U.S. Government Printing Office.

Training

In FY 1996, there were 2 separate weeks of specialized
regulatory training and planning sessions for all regional
supervisory animal care specialists and the headquarters
AC staff. The AC regions also conducted several 2- to
3-day onsite sessions with groups of field personnel
participating throughout the year until the entire field force
was reached, as well as conducting informational
teleconferences on a regular basis. Headquarters staff
participated in many of these regulatory training functions.

Also in FY 1996, three AC personnel received training
through the annual Research Preceptor Program and two
in the Exhibitor Internship program. These programs
could not have been possible without cooperation and
help from industry groups, as described under the
heading of “Other Activities” later in this report.


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Animal Welfare Accomplishments for

FY 1996

Inspections for Compliance Made During FY 1994-96

Total Total
facilities compliance
FY (sites) inspections
1996 7,837
(10,366) 12,635
1995 7,721
(10,108) 14,722
1994 7,869
(10,705) 14,778

Total number Number of
of facilities inspections
and (sites)' by category

Inspections for Compliance?
Dealers 4,075

(4,265) 5,819
Research 1,264
facilities (2,506) 2,790
Exhibitors 2,098

(2,453) 2,851
Intransit 302
handlers (417) 275
Intransit 98
carriers® (725) 901
Total 7,837 12,635

(10,366)

Other Types of Inspections
Prelicensing and
preregistration
inspections‘ NA 1,932
Auction market
inspections NA 59
Attempted inspec-
tions of dealers
and exhibitors NA 1,363
Total 3,354
Total of Inspections for Compliance
and Other Inspections 15,989

* See the glossary of terms for the definition of “site” and “facility.”

? Inspections for compliance are ‘unannounced’ inspections and
reinspections. These do not include prelicensing or preregistration inspec-
tions, auction market inspections, or attempted inspections, (Prelicensing/

preregistration inspections are “announcer

Inspections of licensed and
unlicensed auction markets are made to locate unlicensed deal

lers.

Attempted inspections could not be performed for certain reasons—usually

because there was no one available at the facility when the inspector arrived

unannounced.)

2 Intransit Carriers is a category representing commercial airlines, Each
airline may have two or more animal transportation “sites” at each airport it
serves. Dus to frequent changes in airline activities and other factors, the

number of sites may vary.

* Prelicensing/preregistration audits include 44 preregistration inspections,

which are not required. Many regulated entities request that AC it

facllty for compliance before they begin to use animals. To ensure the
‘highest level of compliance, AC personnel perform these requested

inspections whenever possible.

2

inspect their


Summary of Inspections

APHIS/AC personnel perform prelicensing inspections
because license applicants are required by law to be in
full compliance with regulations and standards before a
license is issued. After a license has been issued, APHIS
performs unannounced inspections and reinspections to
ensure continued compliance with the AWA.
Reinspections are follow up inspections conducted on
those facilities that were found to have one or more
violations.

In FY 1996, APHIS’ AC personnel conducted 12,635
unannounced inspections for compliance, 1,932
prelicensing/preregistration audits, 59 auction market
observations, and 1,363 attempted inspections. There
were also 1,420 searches for unlicensed or unregistered
sites, 3 holding facility inspections, 58 handler or carrier
registrations, and 508 inspections due to public
complaints. Furthermore, AC personnel handled various
legal matters including 304 alleged violator investigations,
379 case submissions, 86 prosecution-related support
activities, and 479 requests acted on to supply legal
documentation such as photos and affidavits.

Prelicensing/Preregistration Inspections

Before a license is granted to dealer or exhibitor
applicants, a prelicensing inspection must be performed
to determine that a facility is in compliance with the AWA.

For registration purposes, a preregistration inspection is
not required, but many facilities request AC consultation.
Whenever possible, AC honors these requests to promote
the highest level of compliance.

Prelicensing/Preregistration Inspections, FY 1994-96

Preregistration
Prelicensing inspections of
inspections of research
FY Total Dealers Exhibitors facilities
1996 1,932 1,355 533 44
1995 1,934 1,369 529 36
1994 1,894 1,361 491 42

Inspections for Compliance

APHIS/AC routinely makes unannounced inspections of
all licensees and registrants to ascertain that they are in
compliance with the regulations. If conditions are
discovered that are not in compliance with the regulations,
AC establishes a deadline for correction of these items.
Inspectors are required to make a reinspection following
the deadline date for correction. If the conditions remain
uncorrected, AC documents them for possible legal
action. Listed in the next tabulation are the total number
of unannounced compliance inspections (including
teinspections) for dealers, exhibitors, research facilities,
carriers, and intermediate handlers for FY 1996 and the
2 previous years.

Inspections for Compliance, FY 1994-96

Unannounced

inspections for
FY compliance
1996 12,635
1995 14,722
1994 14,778
Complaints and Searches

AC personnel routinely conduct searches for unlicensed
or unregistered persons and also investigate public
complaints to determine (1) that regulated animals are
receiving proper care and/or (2) if the animal owner(s) fall
under the jurisdiction of the AWA and should be licensed
or registered. The number of complaints investigated and
searches for unlicensed or unregistered facilities during
FY 1996 and the 2 previous years are tabulated next.

Complaints Investigated and Searches Made,
FY 1994-96

FY Complaints Searches
1996 508 1,420
1995 566 1,728
1994 642 2,354 -

13


Liaison With Other Federal Agencies

APHIS/AC has a representative on the Interagency
Research Animal Committee, whose members come from
Federal agencies involved in the care and use of animals
in biomedical research. This committee is responsible for
interagency coordination of animal care-and-use
concerns and for making contributions to policy
development and acts as a forum for information
exchange and regulation development.

AC works closely with the Animal Welfare Information
Center (AWIC), a unit of the National Agricultural Library.
In FY 1996, AC staff personnel presented two training
sessions on “Information Requirements of the Animal
Welfare Act.” AC staff worked closely with AWIC to
develop a CD ROM called “CARE” which contains many
Official documents concerning the regulation of animal
welfare. This project was partially funded by APHIS.

FY 1996 was the 30th anniversary of the passing of the
AWA. AWIC and AC jointly planned and implemented a
well-attended symposium.

APHIS/AC also maintains close working relationships with
other Federal agencies that deal with animals regarding
regulation and enforcement of the AWA. APHIS
cooperated with the U.S. Department of Health and
Human Services’ National Institutes of Health and Food
and Drug Administration, the Department of Defense, the
Department of Veterans Affairs, the Marine Mammal
Commission, the U.S. Department of Commerce's
National Marine Fisheries Service, the U.S. Department of
the Interior's U.S. Fish and Wildlife Service, the
Environmental Protection Agency, and USDA's Food
Safety and Inspection Service.

Staff Activities

The Marine Mammal Negotiated Rulemaking Committee,
composed of representatives from 11 major stakeholder
groups, APHIS, an independent consultant, and 3
Nonvoting observers (employees of other Federal
agencies), in conjunction with a hired facilitator, met twice
during FY 1996. The committee reached consensus
language on 12 of 18 sections (plus 1 paragraph of the
13th section) of Part 3, Subpart E of 9 CFR, Chapter 1,
Subchapter A. The consensus language will be published
in the Federal Register as a proposed regulation.

APHIS and the American Zoo and Aquarium Association
cosponsored a zoo animal internship program. During FY
1996, two AC field inspectors (one veterinary medical
officer and one animal care inspector) trained at six
different zoological institutions (three each).

APHIS and the research community cosponsored a
research internship program that sent three AC
veterinarians to 6 intensive weeks of training at various
research facilities and teaching institutions.

AC headquarters personnel coordinated monthly liaison
committee meetings with representatives of the National
Marine Fisheries Service, the U.S. Fish and Wildlife
Service, and the Marine Mammal Commission.

AC staff officers attended and participated in national
meetings held by various organizations, including the
international Association of Aquatic Animal Medicine, the
Society of Marine Mammalogy, the Association of Aquatic
Life Support System Operators, the North American
Veterinary Conference, the American Association of
Laboratory Animal Science, and the Public Responsibility
in Medicine and Research.

Headquarters employees worked with the Center for
Alternative Animal Testing and Procter and Gamble on an
important data-base project concerning alternatives to the
use of animals in research.

15


Report of 1996 Activities

Each year, the Secretary of Agriculture reports on
administration and enforcement activities under the
Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.) as
required by Section 25 of the AWA. Section 25 states
that: “[tJhis report as well as any supporting documents,
data, or findings shall not be released to any other
persons, non-Federal agencies, or organizations unless
and until it has been made public by an appropriate
committee of the Senate or the House of
Representatives.”

The present report covers fiscal year (FY) 1996, from
October 1, 1995, through September 30, 1996.

Chart 1

Summary

In FY 1996, 12,635 unannounced compliance inspections
and reinspections were completed by the Animal and
Plant Health Inspection Service's (APHIS) Animal Care
(AC) field personnel at 10,366 regulated sites. There
were 1,932 prelicensing and preregistration audits, 59
auction market observations, and 1,363 attempted
compliance inspections. The total of all categories of
inspections for FY 1996 was 15,989.

The AWA requires that APHIS perform at least one
compliance inspection per year at each research facility
that uses animals in experimentation. Agency policy sets
the same minimum for all other regulated entities using
animals. The number of field inspectors (veterinary
medical officers and animal care inspectors) at the end of
FY 1996 was 71.

Chart 1 shows inspections completed for all facility
categories for FY 1996 and the 2 previous years.

FY 1994-96

Animal Welfare Program Inspections

Dealer 5.854 6,418
5,819

Research

Exhibitor

Intransit handler

Intransit carrier

Prelicensing

Auction market

Attempted

0 2,000

Numbers from Work-Based Budget System (WBBS) reports

3,953
520
(1994
Gi 1995
Ml 1996
4,000 6,000 8,000



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The U.S. Department of Agriculture (USDA) prohibits

discrimination in its programs on the basis of race, color,

national origin, sex, religion, age, disability, political
beliefs, and marital or familial status. (Not all prohibited
bases apply to all programs.) Persons with disabilities
who require alternative means for communication of
program information (braille, large print, audiotape, etc.)
should contact the USDA Office of Communications at
(202) 720-2791.

To file a complaint, write the Secretary of Agriculture, U.S.
Department of Agriculture, Washington, DC 20250, or call
(800) 245-6340 (voice) or (202) 720-1127 (TDD). USDA

is an equal employment opportunity employer.

Issued April 1997

Contents

Report of 1996 Activities 1
Summary 1
Animal Welfare Accomplishments for FY 1996 2
Legislative History 3
Regulations 3
Animal Care's Strategic Direction 4
Appropriations for FY 1996 5
Organization and Administration of the AWA 5
APHIS/AC and IES Headquarters Activities 5
APHIS/AC and IES Field Activities 6
Animal Welfare Information Center 6
Training 6
Licensing and Registration 7
Research Facilities 7
Reports From Research Facilities 8
Animal Exhibitors 10
Carriers and Intermediate Handlers 11
Licensed Dealers 12
Summary of Inspections 13
Prelicensing/Preregistration Inspections 13
Inspections for Compliance 13
Complaints and Searches 13
Violations and Investigations 14
Liaison With Other Federal Agencies 15
Staff Activities 15
Public Information 16
Public Correspondence 16
Freedom of Information Act (FOIA) Requests 17
Legislative and Regulation Recommendations 17
Glossary of Terms 18

Appendix

Table 1. Number of Licensees and Registrants 20
Table 2. Animals Used in Experimentation 22
Table 3. Animals Used in Experimentation,

No Pain or Distress—No drugs 24
Table 4. Animals Used in Experimentation,

With Pain or Distress—With Drugs 26
Table 5. Animals Used in Experimentation,

With Pain or Distress—No Drugs 28
Table 6. Animals Used in Experimentation,

From 1973 30

Attachments

Animal Welfare: List of Licensed Dealers

Animal Welfare: List of Registered Research Facilities

Animal Welfare: List of Licensed Exhibitors and
Registered Exhibitors

Animal Welfare: List of Registered Carriers and
Intermediate Handlers


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27


Carriers and Intermediate Handlers

Carriers registered with USDA include airlines, motor
freight lines, railroads, and other shipping businesses.
Registered intermediate handlers means ground freight
handlers. Intermediate handlers usually provide services
for animals between consignor and carrier and from
carrier to consignee. They also care for animals delayed
in transit. In FY 1996, there were 98 carriers (with a total
of 725 sites) and 302 intermediate handlers (with a total of
417 sites).

The numbers of sites and registered carriers and
intermediate handlers for FY 1994 through 1996 are listed
in the next tabulation. The number of carrier and
intermediate handler inspections for FY 1994 through
1996 is shown on chart 6.

Chart 6

Sites and Registered Carriers and Intermediate Handlers,
FY 1994-96

Registered Intermediate
carrier handlers
FY (sites) (sites)
1996 98 302
(725) (417)
1995 98 275
(453) (303)
1994 109 246
(613) (276)

FY 1994-96

1,800
1,600
1,400
1,200
1,000
800
600
400
200

109 98 98

rial

Carriers and Intermediate Handlers

(J 1994
EB 1995
Hl 1996

a7

275 B02 276 303,

Total carrier Carrier

C Carrier
facilities sites

inspections

Numbers from Work-Based Budget System (WBBS) reports

Total handler
facilities sites

Handler Handler

inspectons

Total intransit
inspections

1



Violations and Investigations

APHIS’ IES personnel investigate alleged violations when
licensees or registrants fail to take the corrective actions
necessary to remain in compliance with the AWA.

Investigations disclosing violations are acted on ina
variety of ways depending on their severity in regard to
endangering the health or well-being of covered animals.
Most infractions may be settled with an official notice of
warning or a stipulation offer. (Stipulations allow alleged
violators to pay a fine, have their license suspended, or
both, in lieu of formal administrative proceedings.) Cases
warranting formal prosecution undergo USDA-level
review for legal sufficiency prior to the issuance of a
formal administrative complaint. Formal cases may be
resolved by license suspensions, revocations, cease-and-
desist orders, civil penalties, or combinations of these
penalties through administrative procedures.

In the tabulation below, it should be noted that the
numbers under “Cases Submitted,” “Cases Resolved,”
and “Sanctions Imposed” are those actions that actually
occurred during the fiscal year even though many of the
settled cases were submitted in previous years. This
numerical disparity occurs because it takes a case
considerable time to work its way through the legal
system and appeals process.

14

Numbers of Investigations Conducted and Disposition,
FY 1994-96

Cases Investigated and Reviewed
Submitted
Submitted for formal
FY Cases to IES staff prosecution
1996 370 126 78
1995 425 150 79
1994 719 147 91
Cases Resolved
. Administrative
Official Stipulations law judges’
FY wamings offered/settled decisions
1996 182 85/45 84
1995 263 131/85 35
1994 389 108/78 44
Sanctions Imposed
Revocations,
Fines imposed by suspensions,
administrative Fines imposed and disquali-
FY law judges by stipulation fications
1996 $1,002,250 $48,340 29
1995 $ 401,750 $49,975 19
1994 $ 296,000 $49,900 23