USDA Not Adequately Enforcing Lab Animal Protection Laws
By M. Alexander Otto
BNA’s Medical Research Law & Policy Report
May 5, 2004
USDA Not Adequately Enforcing Lab Animal Protection
Laws, Group Says
The nation's top animal research labs continue to
violate humane treatment laws despite repeated fines and disciplinary
actions by the U.S. Department of Agriculture, according to an animal
welfare group's review of USDA records.
Between 1999 and 2003, the department found 559
violations of the Animal Welfare Act at 25 university and commercial
labs, many of them leading research centers. Seventy-nine citations were
for repeat violations of the same infractions, Cincinnati-based Stop
Animal Exploitation Now! (SAEN) found in its new report, Breaking the
Law: Animal Care in U.S. Labs.
Cited violations included inadequate veterinary care,
personnel training, food and water, environmental stimulation and
comfort, and sanitation.
The University of California, San Francisco, with
3,365 regulated animals in its care during the three-year period, topped
the list with 51 violations, 30 of which were repeat infractions,
according to the report.
Johns Hopkins University, the leading recipient of
federal research dollars, was sixth with 31 violations for its 4,978
regulated animals. Harvard University ranked 16th with 14 citations for
the 2,502 regulated animals under its care during that time.
Meanwhile, Mount Ida College in Newton, Mass., with
just 40 regulated animals, ranked 11th with 25 AWA violations.
The USDA inspection records for the 25 labs were
compiled by Michael A. Budkie, SAEN executive director, and associates
over several months. Budkie, who trained as an animal lab technician
before becoming an activist, said the goal was to gauge adherence to the
AWA and enforcement of the act by the USDA Animal and Plant Health
Inspection Service (APHIS).
The numbers, Budkie said, may not reflect the true
incidence of violations because APHIS typically inspects labs once a
year or less and labs sometimes have advance warning of visits. Also,
the vast majority of animals used in U.S. labs--rats, mice, and
birds--are not protected by humane treatment laws AWA.
The report did not raise the issue of stopping animal
research, but only of making sure animals used in studies are treated
SAEN’s findings echo those of the Rockville, Md.-based
Association for Assessment and Accreditation of Laboratory Animal Care,
which accredits labs for compliance with federal humane animal treatment
AAALAC also continues to find significant problems in
how animals are treated in medical research laboratories across the
United States. In 2002, 248 AAALAC lab inspections uncovered roughly 125
problems serious enough to block the group from fully accrediting
facilities as meeting federal standards. Each year, the group rejects
about 30 percent of laboratories it inspects for full accreditation, a
figure that has held steady since the mid-1990s.
'The Cost of Doing Business.'
Among examples of USDA-cited violations listed in
SAEN’s report was a dog killed when the cage it was in was run through a
cage washer at the Pfizer Inc.'s Kalamazoo, Mich., research facility.
In other incidents, USDA inspectors found a gravely
ill rhesus monkey "allowed to suffer and die, instead of being
immediately humanely euthanized" after researchers at Hopkins decided to
withhold treatment; pigs left without water at the University of
Pennsylvania; rabbits restrained continuously for 30 consecutive days
while one leg was kept in constant motion at the University of
Pittsburgh; 60 primates left in 100 degree heat with no shelter from the
sun at the University of Oklahoma Health Science Center; and a primate
at Emory University overdosed with a drug to induce Parkinson's disease
and left to linger and die when workers assigned to care for the animal
neglected to do so.
The solution, SAEN said, is stronger enforcement of
the AWA and an act of Congress to give APHIS stronger enforcement
The report noted, for example, that USDA fined the
University of California, San Francisco, in the past, but "for a
facility that receives over $160,000,000 from the National Institutes of
Health for the performance of animal experiments, a $2,000 fine is
little more than pocket change."
Such fines, Budkie said, are considered by some animal
labs as little more than "the cost of doing business."
The USDA official who inspected Pfizer after the dog
was killed noted only that procedures need to be put into place to
prevent the repetition of such an occurrence, according to the report,
which called the response "grossly insufficient."
APHIS Ignored USDA Advice.
Stronger enforcement is the very course of action
recommended by the USDA Office of the Inspector General in 1995 after it
reached conclusions similar to SAEN's following its own investigation.
The IG—which polices USDA offices to make sure they
are doing their job properly—found that "APHIS does not have the
authority, under current legislation, to effectively enforce the
requirements of the Animal Welfare Act. For instance, the agency cannot
terminate or refuse to renew licenses or registrations in cases where
serious or repeat violations occur (such as the use of animals in
unnecessary experiments, or failure to treat diseases or wounds)."
"In addition, APHIS cannot assess monetary penalties
for violations unless the violator agrees to pay them, and penalties are
often so low that violators merely regard them as part of the cost of
doing business," the office found.
The IG recommended that APHIS initiate legislation to
extend its enforcement powers, a course of action that was not followed.
APHIS spokesman Jim Rogers told BNA his office can
levy fines up to $2,750 per animal, per violation, per day. He
acknowledged that APHIS cannot revoke licenses or take other actions to
shut down labs. "That would take an act of Congress," Rogers explained.
He did not respond by press time when asked why APHIS
did not follow the IG's advice, but said it is no longer the case that
AWA violators must agree to penalties.
A second spokesman, Darby Holladay, said APHIS has
been trying for several years to win regulatory authority to refuse to
renew licenses of chronic AWA violators, but that the efforts have been
tied up by the White House Office of Management and Budget, which must
sign off on such changes.
Until enforcement is improved, SAEN said, the "Animal
Welfare Act (however well intended) primarily gives animal laboratories
the ability to say that since they are inspected, and supervised,
conditions within the facilities must be adequate."
Meanwhile, "dogs, cats, primates, pigs, and animals of
many other species are going without veterinary care, without food and
water, and are suffering needlessly," the group said.
Following the IG's lead, SAEN recommended APHIS
initiate legislation to allow it to revoke or withhold renewals of
licenses, fine violators without their permission, and increase fine
The group also called for better policing of painful
and duplicate experiments to stop those deemed unnecessary, as required