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Animal Advocacy Animals in Science and the Animal Welfare Act Valerie A. Lang, J.D., M.L.S.

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Page 1: Animal Welfare Act & Animals in Science

Animal Advocacy

Animals in Science and the Animal Welfare Act

Valerie A. Lang, J.D., M.L.S.

Page 2: Animal Welfare Act & Animals in Science

Animals in Science and the Animal Welfare Act

Page 3: Animal Welfare Act & Animals in Science
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Animal Welfare Act

7 USC Sec. 2131 • The Animal Welfare Act (AWA) is the federal law that governs the humane care, handling, treatment, and transportation of animals used in laboratories. Contrary to popular belief, it does not prohibit any experiment, no matter how painful or useless; it simply sets minimum housing and maintenance standards for confined animals.

– The AWA also covers dealers who sell animals to laboratories, transporters of animals, dog and cat breeders, puppy mills, zoos, circuses, roadside menageries, and animal exhibitors, carriers, and intermediate handlers.

Page 5: Animal Welfare Act & Animals in Science

The Nature of Science Science

• Most science does not deal

with the infliction of pain on nonhuman

animals.

Page 6: Animal Welfare Act & Animals in Science

• Issue first arose in Great Britain• National Anti-Vivisection Society formed in

1875

Policy Discussion

Page 7: Animal Welfare Act & Animals in Science

SPECTRUM OF THOUGHT

Page 8: Animal Welfare Act & Animals in Science

Spectrum of Thought

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Are different species or sources of animals more acceptable than others? (Animals

specifically bred for research use versus stray pets from local government pounds.)

Page 11: Animal Welfare Act & Animals in Science

Are different species or sources of animals more acceptable than others?

Page 12: Animal Welfare Act & Animals in Science

Duties toward these animals?

• Are there duties toward the animals used in research that deal with conditions of housing and care before experiments? What level of pain may be inflicted? What are the duties toward the animal after the experiment?

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If some use of animals is appropriate, then how do you draw the line between

acceptable and unacceptable?

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Remember…

• The first anti-cruelty law in the U.S. adopted in 1867 in N.Y. contained only one exception: the perceived needs of science.– Section 10.

• Nothing in this act contained shall be construed to prohibit or interfere with an properly conducted scientific experiments or investigations… under the authority of the faculty of some regularly incorporated medical college or university…

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• that supports the notion that animals should have a pain-free life.

– The pursuit of science has long been one of the areas where the interests of animals have been set aside for the needs of human

science.

No law exists…

Page 16: Animal Welfare Act & Animals in Science

• Should science be exempt from the general animal protection laws known as

the anti-cruelty laws?

We need to ask ourselves:

Page 17: Animal Welfare Act & Animals in Science

Do we know what constitutes pain and suffering in various species?

• Since animals, unlike humans, usually cannot volunteer to partake in experiments, when is it appropriate to subject

animals to activities which produce pain, suffering or

death?

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Interest of Animals, Scientific Progress

Page 20: Animal Welfare Act & Animals in Science

• From USDA Animal Welfare Reports– Total animals reported used in research

(excluding rats, mice and birds):

• 1985 – 2,153,787 at 1,105 reporting facilities • 1999 – 1,217,998 at 1,232 reporting facilities • 2001 – 705,602 at 1,216 reporting facilities

Animals in Research

Page 21: Animal Welfare Act & Animals in Science

But…

Rats, mice, birds

• Rats and mice represent approximately 90 percent of the animals used in research. They are not included in the above numbers because facilities are not required to report on them.

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1990 1998 2004

Dogs 109,992 70,541- 64,932-

Cats 33,700 23,238- 23,640+

Primates 47,177 54,927+ 54,998+

Rabbits 399,264 288,222- 261,573-

Animals in Research – does not include rats and mice, which run into the millions each year

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Why a meaningful reduction?3 Main Reasons:

• (1) Individual scientists are increasingly unable to make these decisions behind closed laboratory doors.– Most institutions have Animal Care

Committees in place that require anyone undertaking scientific research where animals are involved to first justify their proposal by full presentation to the Committee.

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Page 25: Animal Welfare Act & Animals in Science

Why a meaningful reduction?3 Main Reasons:

• (2) There has been increasing awareness that the housing of animals before and after experimentation raises as many

issues than the experiments themselves.

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Why a meaningful reduction?3 Main Reasons:

• (3) The cost of keeping animals has become significant enough that economic factors can contribute to reductions in the number of animals used. This increased cost even prompts some researchers to

seek alternatives to the use of live animals.

Page 27: Animal Welfare Act & Animals in Science

Would you believe…

The USDA itself has become a focus point for finding alternatives to

the use of animals in research.Click here.

Page 28: Animal Welfare Act & Animals in Science

So let’s get on with the story of

the Animal Welfare Act

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1960s

• Two big issues brewing– (1) Animals in science, research and testing– (2) Story in Life magazine about how pet dogs

and cats were being stolen and sold to research facilities

• (Life, Vol. 60, Feb. 4, 1966)

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Page 31: Animal Welfare Act & Animals in Science

Summary of AWA Over Time

• 1966 law – created a licensing system for animal dealers and laboratories that use dogs, cats, rabbits, monkeys, hamsters and guinea pigs.

• Limited to care, handling, housing, and transport conditions of prior to ultimate use by research facilities

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1966 Law – 3 Main Purposes:

• (1) To protect owners of pet dogs and cats from theft

• (2) To prevent the use or sale of stolen cats or dogs for purposes of research or experimentation

• (3) To establish humane standards for the treatment of dogs, cats and certain other animals by animal dealers and research facilities

Page 33: Animal Welfare Act & Animals in Science

In 1966, after significant lobbying by a number of scientific organizations,

Congress opted not to interfere with the use of animals in research, teaching or

tests by research facilities.

Hands off approach

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Page 35: Animal Welfare Act & Animals in Science

Source of the Dogs and Cats:Illegal, Stolen Animals

• Now, back in 1966 as the AWA was just evolving, the demand for research animals was so high that there was a huge demand for stolen pets. Stolen pets were quickly moved across state lines and the system was inadequate in apprehending and / or convicting the thieves.

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Illegal, Stolen Animals

• So, the AWA prohibited any registered research institution from acquiring dogs or cats from any source other than government licensed sources.

Page 38: Animal Welfare Act & Animals in Science

1966 Law

(1) Secretary of Agriculture had to set up a regulatory program to license all dealers in dogs

and cats and a system of record keeping was

required for all dealers and research facilities.

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1966 Law

(2) All animal dealers were required to register with the USDA, and research facilities were

required to purchase dogs and cats from only licensed dealers.

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1966 Law

(3) The law directed the Secretary of Agriculture to provide humane care provisions enforceable

through inspections.

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1970 Amendments

• (1) Definition of animal was expanded to include warm-blooded animals generally (1966 law only included dogs, cats, primates, guinea pigs, hamsters and rabbits).

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1970 Amendments

• (2) Animal exhibitors (such as zoos, circuses and roadside shows) and wholesale pet dealers were brought under the regulatory provisions of the Act.– Exhibitors and dealers had to have licenses to

operate and became subject to inspections

Page 43: Animal Welfare Act & Animals in Science

1970 Amendments

• (3) Certain humane standards in laboratories were to be maintained at all times.

• Temperature, food, water

• Pain-killing drugs if they did not interfere with research – but this is a real loophole.

Page 44: Animal Welfare Act & Animals in Science

1976 Amendments

• Didn’t deal with research facilities and dealers. Instead, dealt with:

• Transportation carriers and handlers, and

• A new provision was added to make it a crime to knowingly sponsor, participate in, transport, or use the mail to promote animal fighting.

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Page 46: Animal Welfare Act & Animals in Science

1985 Amendments

Focused mainly on issue of animal research

Page 47: Animal Welfare Act & Animals in Science

1985 Amendments

– Minimum levels of care were defined more clearly.

• Required dogs held by research facilities to be exercised

• Required a physical environment adequate to promote the psychological well-being of primates

– This was the first time that Congress extended scope of the law beyond just physical requirements like food and water. Lawmakers acknowledged that primates have legal interests in some quality of mental life.

Page 48: Animal Welfare Act & Animals in Science

1985 Amendments

Animal research facilities were required to create Institutional Animal Committees and include a member of the public on the committee.

First time Congress directly stated that its intent was to govern by regulation certain actions that might occur during a scientific experiment.

Page 49: Animal Welfare Act & Animals in Science

Institutional Animal Care Committees

The primary statutory responsibility of the committee is to engage in

inspections of the research facility at least twice a year.

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Institutional Animal Care Committees

• (A) At least one member shall be a doctor of veterinary medicine

• (B) At least one member– Shall not be affiliated in any way with such facility

other than as a member of the Committee

– Shall not be a member of the immediate family of a person who is affiliated with such facility

– Is intended to provide representation for general community interests in the proper care and treatment of animals

Page 51: Animal Welfare Act & Animals in Science

2002 Amendments (Progress?)

• Provisions which would have stiffened penalties for animal fighting did not pass.

• Early versions of the bill mandated the humane euthanasia of “downers” (animals who are too sick or injured to walk in to a slaughterhouse) but these proposed changes were also eliminated.

Page 52: Animal Welfare Act & Animals in Science

2002 Amendments

• The USDA had just agreed to expand the definition of “research animal” to include rats, mice and birds. However, Sen. Jesse Helms from NC proposed an amendment, which passed, that denied AWA protection to these creatures.

• As a result, birds, mice and rats are not protected by the AWA.

Page 54: Animal Welfare Act & Animals in Science

Not a broad anti-cruelty law and does NOT deal with all species

Page 55: Animal Welfare Act & Animals in Science

Use of animals in K-12 education Hunting, fishing, trapping Slaughter (under the federal Humane Slaughter Act)Animals in agriculture productionRetail pet storesVeterinary care of animals outside licensed and registered institutionsInjuries by animals or inflicted upon animalsAnimals other than mammals (reptiles)State and county fairs, livestock shows, rodeos, purebred dog and cat shows

NOT COVERED BY THE AWA:

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Page 58: Animal Welfare Act & Animals in Science
Page 59: Animal Welfare Act & Animals in Science

SO what IS covered by the AWA?

Page 60: Animal Welfare Act & Animals in Science

Covered by the AWA:• Theft of pet dogs and cats being sold to research and testing

facilities• Breeding and wholesale distribution of some mammals

– (mostly dogs and circus animals)• Auctions• Animals in research labs (universities and private industry) including

horses used as research• Transportation of listed animals• Mammals in zoos and exhibitions (but this excludes state and

county fairs, livestock shows, rodeos, purebred dog and cat shows, and any other fairs intended to advance agricultural arts and sciences)

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Page 62: Animal Welfare Act & Animals in Science

Animal Welfare Act is a regulatory scheme of licenses and inspections to establish

minimum conditions

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Congress delegated the job of developing particular

requirements for the care of animals to the USDA, and in particular, the USDA’s Animal and Plant Health

Inspection Service (APHIS)

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These requirements are species-specific.

• Example: If a cat is kept in a cage in an institution registered under the AWA, then the keeper of the cat must satisfy the following regulations:– (a) Heating, cooling and temperature. The sheltered

part of sheltered housing facilities for dogs and cats must be sufficiently heated and cooled when necessary to protect the dogs and cats from temperature or humidity extremes and to provide for their health and well-being. The ambient temperature in the sheltered part of the facility must not fall below 50 deg. (10 deg. C) for dogs and cats not acclimated to lower temperatures…

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Dog Exercise and Primate Psychological Well-Being

AWA Regulations

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This is the cage size which satisfies the regulations for great apes.

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Sec. 3.81 Environment enhancement to promote psychological well-being.

Primates

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates.

The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency..

Page 72: Animal Welfare Act & Animals in Science

An Insider’s View:Viktor Reinhardt

The Impossible Housing and Handling Conditions of Monkeys in

Research Laboratories C-16C-16

Page 73: Animal Welfare Act & Animals in Science

Animal Legal Defense Fund : Landmarks & Victories

Page 75: Animal Welfare Act & Animals in Science

ALDF v. Glickman

• When ALDF discovered a chimpanzee named Barney in a U.S. Department of Agriculture (USDA)-licensed roadside zoo, he was languishing in solitary confinement on the cement floor of a cage. Deprived of companionship and veterinary care, he suffered from severe psychological and physical distress until he escaped from his cage and was shot and killed by a zoo employee. On behalf of Mark Jurnove, a frequent zoo visitor disturbed by the isolation and neglect that marked Barney’s daily life, ALDF sued the USDA for failing to set standards to protect primates under the federal Animal Welfare Act (AWA).

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ALDF v. Glickman• In October 1996, a U.S. District Court Judge found the USDA in

violation of the AWA and ordered the agency to develop stricter standards, emphasizing the need to address the psychological well-

being of primates in captivity. U.S. District Court Judge Charles Richey called the USDA’s failure to issue such standards.

"egregious." "This case involves an abject failure in the rulemaking process…to enforce the AWA," he stated.

Page 78: Animal Welfare Act & Animals in Science

ALDF v. Glickman• While the Court of Appeals later held that the "standards" set by the

USDA were already adequate, they upheld the decision that Jurnove did have legal standing to sue to protect the interests of animals under the AWA. This decision established that animal

activists have standing to sue under the Animal Welfare Act and has been cited frequently in subsequent litigation promoting humane

treatment of animals.

Page 79: Animal Welfare Act & Animals in Science

BARNEY Page C-21 Heart of MatterBarney

Page 80: Animal Welfare Act & Animals in Science

The Law does not require the elimination of pain and distress.

Requires that pain and distress be “minimized”

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Page 82: Animal Welfare Act & Animals in Science

Risk of pet theft is Risk of pet theft is not with research institutionsnot with research institutions but but farther back in the chain of transfer.farther back in the chain of transfer.

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Euthanized

Humane Society(Private)

City Pound(Govt.)

Euthanized

Pet Owners

Stolen Collectors

CLASS BDEALERS(Licensed)

CLASS ADEALER(Private

Breeders)

Auctions

ExhibitorsCLASS C

CLASS BDEALERSPurpose

Bred Animals

Profit Corp.Research &

Testing

Research Institution

Vet & Medical Schools

Page 85: Animal Welfare Act & Animals in Science

The problem lies in someone stealing the animals and selling them to a licensed dealer.

So, dealers are required to do their homework and require proof of ownership from those they purchase the animals from.

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Page 88: Animal Welfare Act & Animals in Science

Source of Dogs and Cats:Source of Dogs and Cats:Legal, Random SourcesLegal, Random Sources

Aside from us of stolen pets for research, Aside from us of stolen pets for research, the use of EX-PETS generates a lot of the use of EX-PETS generates a lot of debate. debate. The issue arises when local shelters or The issue arises when local shelters or

pounds sell ex-pets rather than euthanize pounds sell ex-pets rather than euthanize them. them.

Prior owners are usually not aware of this Prior owners are usually not aware of this possibility.possibility.

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Page 90: Animal Welfare Act & Animals in Science

Class A, B, and C DealersClass A, B, and C Dealers

Class “A” License (breeder)Class “A” License (breeder) – – business involves only animals that are business involves only animals that are bred and raised on the premisesbred and raised on the premises

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Class A, B and C DealersClass A, B and C Dealers

Class “B” l icenseeClass “B” l icensee means a person means a person whose business includes the purchase whose business includes the purchase and/or resale of any animal. Class B and/or resale of any animal. Class B licensees include brokers, and operators licensees include brokers, and operators of an auction sale. Usually do not take of an auction sale. Usually do not take physical possession of the animals.physical possession of the animals. But C.C. Baird operated differently. He took But C.C. Baird operated differently. He took

possession of the animals.possession of the animals.

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Page 93: Animal Welfare Act & Animals in Science

Class A, B and C DealersClass A, B and C Dealers

Class “C” (exhibitor)Class “C” (exhibitor) means a person means a person who business involves the showing or who business involves the showing or displaying of animals to the public. displaying of animals to the public.

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AWA is REGULATORYAWA is REGULATORY

All facilities licensed or registered under All facilities licensed or registered under the Animal Welfare Act are inspected. the Animal Welfare Act are inspected.

Requested inspection reports and Requested inspection reports and supporting documentation can be found supporting documentation can be found

herehere..

Page 95: Animal Welfare Act & Animals in Science

Section 4 of the AWASection 4 of the AWA

No No dealerdealer or or exhibitorexhibitor shall sell or offer to shall sell or offer to sellsell or transport or offer for transportation, in or transport or offer for transportation, in commerce, commerce, to any research facil i tyto any research facil i ty or for or for exhibition or for use as a pet any animal, or buy, exhibition or for use as a pet any animal, or buy, sell, offer to buy or sell, transport or offer for sell, offer to buy or sell, transport or offer for transportation, in commerce, transportation, in commerce, to or from to or from another another dealer or exhibitordealer or exhibitor under this chapter any under this chapter any animals, animals, unless and unti l such dealer or unless and unti l such dealer or exhibitor shall have obtained a l icenseexhibitor shall have obtained a l icense from the Secretary and such license shall not from the Secretary and such license shall not have been suspended or revoked.have been suspended or revoked.

Page 96: Animal Welfare Act & Animals in Science

Dealer DefinedDealer Defined

The term “dealer” means any person who, The term “dealer” means any person who, in commerce, for compensation or profit, in commerce, for compensation or profit, delivers for transportation, or transports, delivers for transportation, or transports, except as a carrier, buys, or sells, or except as a carrier, buys, or sells, or negotiates the purchase or sale ofnegotiates the purchase or sale of

(1) any dog or other animal whether alive (1) any dog or other animal whether alive or dead for research, teaching, exhibition, or dead for research, teaching, exhibition, or use as a pet, oror use as a pet, or

Page 97: Animal Welfare Act & Animals in Science

Dealer DefinedDealer Defined

(2) any dog for hunting, security, or (2) any dog for hunting, security, or breeding purposes, except that this term breeding purposes, except that this term does not include-does not include- ( i) a ( i) a retail pet storeretail pet store except such store which except such store which

sells any animals to a research facil i ty, an sells any animals to a research facil i ty, an exhibitor, or a dealer.exhibitor, or a dealer.

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Recap:Recap:

Recap:Recap: 1.1. The USDA is responsible for The USDA is responsible for

coming up with regulations necessary for coming up with regulations necessary for enforcing the AWA.enforcing the AWA.

2.2. Within the USDA, the Animal and Within the USDA, the Animal and Plant Health Inspection Service (“APHIS”) Plant Health Inspection Service (“APHIS”) investigates.investigates.

Page 99: Animal Welfare Act & Animals in Science

Two Types of Investigations:Two Types of Investigations:

Routine (no advance notice)Routine (no advance notice) As a result of complaint filed – APHIS is As a result of complaint filed – APHIS is

required to investigaterequired to investigate

Page 100: Animal Welfare Act & Animals in Science

Violation ProcedureViolation Procedure

If USDA thinks violation deserves sanctions, a civil complaint filed within the USDA.

(1) Administrative Law Judge presides (ALJ appointed by USDA)

(2) Suspension or revocation of license and civil fines

(3) If the decision of the Administrative Law Judge is appealed, it goes to a Judicial Officer (usually defers to ALJ).

Page 101: Animal Welfare Act & Animals in Science

Average LengthAverage Length540 DAYS!540 DAYS!

(Once violations are noted and get to (Once violations are noted and get to the point where the person or entity is the point where the person or entity is

taken to court)taken to court)

Page 102: Animal Welfare Act & Animals in Science

For a list of For a list of PEOPLEPEOPLE who who are are exempt exempt from licensing from licensing

requirements see page 384.requirements see page 384.

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Animals Included Under the AWAAnimals Included Under the AWA

Live or deadLive or dead Dog or cat – wild or domesticDog or cat – wild or domestic Monkey (“nonhuman primate mammal”)Monkey (“nonhuman primate mammal”) Warm-blooded animals except birds, rats, Warm-blooded animals except birds, rats,

micemice

Page 105: Animal Welfare Act & Animals in Science

Animals NOT Covered by the Animals NOT Covered by the AWAAWA

Horses used as pets, or for exhibition, or on Horses used as pets, or for exhibition, or on farmsfarms

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Animals NOT Covered by the Animals NOT Covered by the AWAAWA

Farm animals intended for use as foodFarm animals intended for use as food

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Animals NOT Covered by the AWAAnimals NOT Covered by the AWA

Livestock or poultry used for improving Livestock or poultry used for improving animal nutritionanimal nutrition So a sheep used in different experiments at So a sheep used in different experiments at

the same university are subject to different the same university are subject to different rules:rules:

Page 108: Animal Welfare Act & Animals in Science

When sheep are used in a medical center to study When sheep are used in a medical center to study use of drugs in preventing premature birth, the use of drugs in preventing premature birth, the sheep are protected under the AWA.sheep are protected under the AWA.

Same sheep if used for nutritional studies are not Same sheep if used for nutritional studies are not covered.covered.

Page 109: Animal Welfare Act & Animals in Science

ENTERENTER PAWS PAWS

Why is the bil l necessary?Why is the bil l necessary? The PAWS bill is necessary because The PAWS bill is necessary because

currently all commercial breeders of dogs currently all commercial breeders of dogs and cats who sell their animals directly to and cats who sell their animals directly to the public avoid AWA licensing and the public avoid AWA licensing and humane handling requirements even humane handling requirements even when they are selling a large number of when they are selling a large number of animals. animals. 

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Page 111: Animal Welfare Act & Animals in Science

Pet Animal Welfare Statute Pet Animal Welfare Statute (PAWS) – (PAWS) – 2007 - NEVER BECAME LAW2007 - NEVER BECAME LAW

Strengthens existing law covering commercial breeding Strengthens existing law covering commercial breeding facilities by amending the Animal Welfare Act (AWA). facilities by amending the Animal Welfare Act (AWA). 

The PAWS legislation would require that any commercial The PAWS legislation would require that any commercial breeder who sells more than six litters of dogs or cats, breeder who sells more than six litters of dogs or cats, and produces more than 25 puppies or kittens, directly to and produces more than 25 puppies or kittens, directly to the public in a year be licensed by the U.S. Department the public in a year be licensed by the U.S. Department of Agriculture (USDA). of Agriculture (USDA).

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PAWSPAWS

The growing popularity of the Internet has The growing popularity of the Internet has created an unintentional loophole in the current created an unintentional loophole in the current law, allowing these commercial breeders to law, allowing these commercial breeders to classify themselves "retail pet stores" and evade classify themselves "retail pet stores" and evade all federal oversight. As a result, raising animals all federal oversight. As a result, raising animals in deplorable conditions and selling them to in deplorable conditions and selling them to someone sight unseen has become even easier, someone sight unseen has become even easier, and is a highly profitable business. These high and is a highly profitable business. These high volume dealers are commonly referred to as volume dealers are commonly referred to as "puppy mills.""puppy mills."

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PAWSPAWS

Some of the more technical aspects of the Some of the more technical aspects of the bill address a growing frustration that the bill address a growing frustration that the enforcement of the AWA has been enforcement of the AWA has been hampered by cumbersome procedures hampered by cumbersome procedures and limited resources. One great concern and limited resources. One great concern has been the growing number of breeders has been the growing number of breeders overseas who see the United States as a overseas who see the United States as a lucrative market for dogs, whom breeders lucrative market for dogs, whom breeders can mass produce with no humane can mass produce with no humane regulations or oversight. regulations or oversight.

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PAWSPAWS

The public source records section of the bill will The public source records section of the bill will allow the USDA to determine the origin of dogs allow the USDA to determine the origin of dogs and cats coming into the United States and trace and cats coming into the United States and trace their pathway, allowing for better control of their pathway, allowing for better control of disease and inhumane treatment. Sections disease and inhumane treatment. Sections expanding the temporary suspension and giving expanding the temporary suspension and giving the USDA the ability to enjoin breeding the USDA the ability to enjoin breeding operations will enhance the USDA's operations will enhance the USDA's enforcement capability.enforcement capability.

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PAWSPAWS

This bill will not regulate people who sell an This bill will not regulate people who sell an occasional litter of puppies, but will give the occasional litter of puppies, but will give the USDA the opportunity to inspect and ensure USDA the opportunity to inspect and ensure humane treatment of animals at large facilities. humane treatment of animals at large facilities. The bill is carefully aimed at closing the current The bill is carefully aimed at closing the current loophole in the AWA that allows commercial loophole in the AWA that allows commercial breeders who sell over the Internet to go breeders who sell over the Internet to go unchecked.unchecked.

Page 118: Animal Welfare Act & Animals in Science

Roach Case, 1992Roach Case, 1992

Trying to get around the Trying to get around the law….law….

Page 119: Animal Welfare Act & Animals in Science

Roach Laboratories Case, 1992 Roach Laboratories Case, 1992 Roach Roach producedproduced and sold an and sold an antiserumantiserum from the blood of from the blood of rabbits, rabbits,

goats, and sheepgoats, and sheep..Antiserum production involves Antiserum production involves injection into a live animal injection into a live animal followed by followed by

extraction of blood.extraction of blood.

Page 120: Animal Welfare Act & Animals in Science

Complaint filed by the Administrator of APHIS Complaint filed by the Administrator of APHIS (USDA’s Animal & Plant Health Inspection (USDA’s Animal & Plant Health Inspection Service)Service)

Alleged that Roach operated as a Alleged that Roach operated as a dealerdealer without being licensedwithout being licensed

Operated a Operated a research facility without being research facility without being registeredregistered

Refused to allow APHIS to inspect Refused to allow APHIS to inspect the records the records and facilities of Roach Laboratoriesand facilities of Roach Laboratories

Roach Laboratories Case, 1992Roach Laboratories Case, 1992

Page 121: Animal Welfare Act & Animals in Science

Roach’s defense:

• Roach argued he was not a dealer and therefore did not require a dealer’s license.– He tried to make the

argument that there is a difference between selling serum and antiserum and that he only tested blood from individual animals instead of a pool of animals.

Page 122: Animal Welfare Act & Animals in Science

Roach’s defense:

Roach also said he

did not obtain the

rabbits from a dealer

in commerce .

For these procedures, Roach bought 198 rabbits from Shelton’s Bunny Barn, which is a licensed dealer under the AWA.

Page 123: Animal Welfare Act & Animals in Science

Roach’s defense:Roach’s defense:Research Facil i tyResearch Facil i ty

Roach said thatRoach said thathe he was not is not awas not is not a““research facility”research facility”as defined by theas defined by theAnimal Welfare ActAnimal Welfare Actand and therefore wastherefore wasnot required to benot required to beregistered registered with thewith theUSDA.USDA.

Animal Welfare ActAnimal Welfare Act

Page 124: Animal Welfare Act & Animals in Science

What is a research facility?What is a research facility?

That’s all the law says.That’s all the law says. 7 U.S.C. § 2132 (e) The term 7 U.S.C. § 2132 (e) The term

“research facility” “research facility” means any school means any school (except an elementary or secondary (except an elementary or secondary school), institution, organization, or school), institution, organization, or person that person that uses or intends to use uses or intends to use live animals in research, tests, or live animals in research, tests, or experiments, experiments, andand that (1) purchases that (1) purchases or transports live animals in or transports live animals in commerce, commerce, oror (2) receives funds (2) receives funds under a grant, award, loan, or under a grant, award, loan, or contract contract from a department, agency, from a department, agency, or instrumentality of the United or instrumentality of the United States for the purpose of carrying States for the purpose of carrying out research, tests, or experiments.out research, tests, or experiments.

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Court found:Court found:

Roach was a dealer and Roach was a dealer and should be licensed as should be licensed as such.such.

Roach was a research Roach was a research facility and should be facility and should be registered as such.registered as such.

Roach should allow Roach should allow inspections of the inspections of the facilities as required by facilities as required by the AWA.the AWA.

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Page C-9Page C-9And see Case Study C-3 on Page C-12And see Case Study C-3 on Page C-12

Case Study C-2Case Study C-2

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ChallengesChallenges

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Final Report On Environment Enhancement To Promote The Psychological Well-being Of

Nonhuman Primates

U. S. Department of Agriculture Animal and Plant Health Inspection ServiceAnimal Care, Riverdale, MD

July 15, 1999

What follows is a summary of issues raised in both the mail survey and telephone

interviews of APHIS Animal Care employees… C-25

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Results of Surveys & InterviewsResults of Surveys & Interviews

Minimum Criteria Needs ClarificationMinimum Criteria Needs Clarification Lack of EnforceabilityLack of Enforceability Minimalistic and One-Sided Enhancement Minimalistic and One-Sided Enhancement

ProgramsPrograms Questionable Implementation of the Facility Questionable Implementation of the Facility

PlansPlans Low Levels of Appropriate Social GroupingLow Levels of Appropriate Social Grouping Practices that Perpetuate Abnormal BehaviorPractices that Perpetuate Abnormal Behavior Poorly Furnished EnvironmentsPoorly Furnished Environments

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1. Minimum Criteria Need 1. Minimum Criteria Need ClarificationClarification

The standards in 9 CFR §3.81 emphasize The standards in 9 CFR §3.81 emphasize the presence of a physical document called the presence of a physical document called an an “environment enhancement plan for “environment enhancement plan for primates”primates” at each facility, but the standards at each facility, but the standards contain few solid criteria on which an contain few solid criteria on which an inspector can judge the content of the plan inspector can judge the content of the plan as “in compliance” or “out of compliance.” as “in compliance” or “out of compliance.” The regulations state that the plan must The regulations state that the plan must address social grouping, enrichment of the address social grouping, enrichment of the physical environment, special physical environment, special considerations, and restraint devices, but considerations, and restraint devices, but what is required in order to address these in what is required in order to address these in a minimally compliant manner is unclear. a minimally compliant manner is unclear. Some inspectors said they had the Some inspectors said they had the impression that the only legally necessary impression that the only legally necessary condition for compliance was the existence condition for compliance was the existence of the document itself, regardless of its of the document itself, regardless of its contents. contents.

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Some inspectors said they could recognize a Some inspectors said they could recognize a plan that was not in accordance with plan that was not in accordance with professional literature or was not “adequate to professional literature or was not “adequate to promote psychological well-being.” promote psychological well-being.” i.e., the i.e., the inspectors said if it’s bad, they can tell.inspectors said if it’s bad, they can tell. However, they had concerns about However, they had concerns about Agency support Agency support

for particular interpretations or judgement because for particular interpretations or judgement because of the of the vague language vague language and nature of the and nature of the performance standard.performance standard.

2. Lack of Enforceability2. Lack of Enforceability

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Many employees supported the idea that Many employees supported the idea that enhancement programs enhancement programs be required to be required to address several different aspects address several different aspects of a of a primate’s environment and behavior, primate’s environment and behavior, beyond the superficial breakdown.beyond the superficial breakdown. E.g., feeding of treats or provision with a E.g., feeding of treats or provision with a

simple rubber toysimple rubber toy, in an , in an otherwise barren, otherwise barren, stimulus-poor environmentstimulus-poor environment

3. One-Sided ‘Enhancement’Programs3. One-Sided ‘Enhancement’Programs

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4. Questionable 4. Questionable ImplementationImplementation

Animal Care inspectors Animal Care inspectors recommended facilities be required recommended facilities be required to provide better documentation of to provide better documentation of

implementation.implementation.

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5. Low Levels of Social Grouping5. Low Levels of Social Grouping

Some Animal Care Some Animal Care inspectors felt that there inspectors felt that there were too many singly were too many singly housed primates. housed primates. All of these reasons reflect All of these reasons reflect

convenience for the convenience for the owner(s), not primary owner(s), not primary consideration for the consideration for the psychological needs of the psychological needs of the animals.animals.

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6. Practices that Perpetuate Socially Incompetent 6. Practices that Perpetuate Socially Incompetent Individuals or Abnormal BehaviorIndividuals or Abnormal Behavior

Animal Care inspectors were Animal Care inspectors were concerned that dealers concerned that dealers involved in the pet trade involved in the pet trade continue to remove infants continue to remove infants from their care-giving parent(s) from their care-giving parent(s) at an inappropriately early age, at an inappropriately early age, for reasons other than medical for reasons other than medical necessity. necessity. These practices are known to These practices are known to

produce produce socially incompetent socially incompetent adults adults and contribute to the low and contribute to the low levels of social grouping already levels of social grouping already identified.identified.

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7. Poorly Furnished Environments7. Poorly Furnished EnvironmentsC-27C-27

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In conjunction with the release of this reportIn conjunction with the release of this report, a , a policy was proposed and published, Animal and policy was proposed and published, Animal and Plant Health Inspection Service, Draft Policy on Plant Health Inspection Service, Draft Policy on Environment Enhancement for Nonhuman Environment Enhancement for Nonhuman Primates, Federal Register: Primates, Federal Register: July 15, 1999 July 15, 1999 (Volume 64, Number 135) page 38145-38150 (Volume 64, Number 135) page 38145-38150 [Proposed Rules] [Docket No. 98-121-1]. But this [Proposed Rules] [Docket No. 98-121-1]. But this was a policy for “guidance” not proposed new was a policy for “guidance” not proposed new regulations, and regulations, and has yet to be finalized into a has yet to be finalized into a formal policy of the agencyformal policy of the agency..

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If you want an accurate, excellent analysis of the AWA, If you want an accurate, excellent analysis of the AWA, click here.click here.

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Association for Assessment and Association for Assessment and Accreditation of Laboratory Accreditation of Laboratory Animal Care C-31 *** The Animal Care C-31 *** The

Future?Future?

Enter AAALACAEnter AAALACA

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Animal LawAnimal Law CRJS 231 CRJS 231

Hudson Valley Community Hudson Valley Community CollegeCollege

Valerie A. Lang, J.D., M.L.S.Valerie A. Lang, J.D., M.L.S.