When an undercover investigation
reveals that circus
trainers are using bullhooks to
beat baby elephants or that workers in an animal research laboratory are slamming cats into
cages and denying veterinary care to dogs with worm infestations, abscessed
teeth, and open, oozing sores, PETA files complaints with the U.S. Department
of Agriculture (USDA). The USDA is the government agency responsible for the
regulation of food safety, nutrition, agriculture, and natural resources as
well as the enforcement of the Animal Welfare Act (AWA), the only federal law
that governs the treatment of animals who are bred for commercial use
(including dogs bred in puppy mills and rabbits bred for experimentation), used
in public exhibitions (such as circuses and zoos), and experimented on in U.S.
laboratories. The AWA stipulates minimal standards for the treatment of animals
in such facilities, but shockingly, it does not cover mice, rats, and birds, who make up
approximately 95 percent of all animals used in laboratories. Moreover, the AWA
does not prohibit any experiment, no matter how painful, trivial, or
duplicative. It allows animals to be burned, shocked, poisoned, paralyzed,
starved, cut into, brain-damaged, decapitated, and killed. However, PETA helps
ensure that the modicum of protection afforded to animals by the AWA is
implemented—and that violators are penalized.
The USDA's Animal and Plant Health
Inspection Service (APHIS) is responsible for
enforcing the AWA. APHIS licenses and registers animal businesses, such as
circuses, breeders, and animal laboratories. While APHIS conducts annual
inspections to ensure that facilities are adhering to the AWA and associated regulations, the USDA's Office of Inspector General has repeatedly found that APHIS is not adequately inspecting facilities or
enforcing the AWA. Currently, there are only about 100 USDA inspectors to oversee
more than 9,000 facilities (1,200 of which are animal experimentation labs),
and labs housing thousands of animals may be inspected in just one day. Furthermore,
the USDA relies primarily on laboratories' own Institutional Animal Care and Use Committees (IACUCs) to
enforce the AWA locally. IACUCs are composed mainly of animal experimenters,
and they approve 98 percent of the projects that are proposed.
PETA's involvement with the USDA
extends beyond violations and enforcement of the AWA. APHIS is also charged
with the regulation of veterinary vaccine production and testing. While these
experiments are meant to save animals from disease, they end up killing
millions of animals in the process because of the testing that the USDA
The USDA's Center for Veterinary Biologics
(CVB) is charged with
ensuring the safety and consistency of veterinary vaccines. Despite the great
strides in science over the last 100 years, USDA batch potency regulations have
changed very little since their introduction, and many vaccines continue to
rely on old-fashioned,
animal-intensive methods for vaccine testing.
However, there have been some
critical advances for a number of veterinary vaccines, and PETA has made
tremendous efforts to ensure the greatest possible use of newer methods so that
the lethal methods of the last century will be completely retired. Of the
approximately 10 million animals used each year for vaccine and other
biological batch control testing, 80 percent are used for quality control for
each batch of vaccines and other biologics, making this area of animal use a
priority for PETA's scientists. PETA has published a paper highlighting some of the larger successes of the paradigm that it developed to
encourage the adoption of novel, non-animal methods for vaccine testing and regularly
corresponds with the CVB on vaccine issues as they relate to animal welfare.
The AWA states that the use of
animals in experiments should be approved only when alternatives are not
available, but some companies use thousands of
hamsters for leptospirosis vaccine potency tests even though a modern, humane non-animal method was
approved by the CVB in 2006. When animals are used for leptospirosis vaccine
tests, 40 hamsters are injected with the live bacteria that cause this disease. The
experiments can last up to five weeks and cause hamsters to experience such
painful conditions as blood poisoning and kidney damage before dying—all
without pain relief.
The Colorado Serum Company, for example, has used more than 1,800
hamsters since 2006 in these painful and ultimately lethal tests. In 2010, PETA filed a complaint with the USDA calling for an investigation into the company's persistence in continuing to experiment on hamsters rather
than using the CVB-approved non-animal test.
Click here to contact the Colorado Serum Company and ask
that it replace the use of hamsters in its leptospirosis
vaccine testing with available non-animal methods.
In 2009, PETA wrote to the CVB asking that the USDA follow Europe's example
and adopt a non-animal in vitro test for the erysipelas vaccine. Erysipelothrix rhusiopathiae is
a bacterium that typically infects pigs who are crammed together on factory farms and in other places where infectious diseases are common and
spread rapidly. Erysipelas infection can cause fever, chronic arthritis, heart
inflammation, painful skin lesions, and often death. Each batch of the
erysipelas vaccine used at the time
was tested by intentionally infecting pigs with the disease, causing immense
suffering and, in some cases, death.
PETA's letters to the CVB
pointed out that the in vitro enzyme-linked immunosorbent assay (ELISA)
test adopted by the European Union (EU) is more humane, is more reliable than
simply administering the vaccine and seeing whether or not the pigs die, and
helps ensure vaccine consistency. The CVB agreed, and the agency announced in
2009 that it would permanently end the use of pigs in these
In 2004, the EU
conducted a large-scale validation study of the in vitro ELISA test for Newcastle disease virus (NDV). While this
non-animal test is being used in the EU, the U.S. still mandates that NDV
vaccine testing be conducted on chickens. PETA encouraged the CVB to conduct a similar validation study of U.S. NDV
vaccine manufacturers, only to be told by the CVB that in vitro tests are incompatible with U.S. NDV vaccines. Although
the CVB allows individual NDV vaccine manufacturers to use the ELISA test, the agency
does not mandate it, thus there is no guarantee that any company in the U.S.
will use it. Furthermore, many NDV vaccine manufacturers have both U.S. and
international status, leading to possible redundancy of potency testing on
To shed light on what
is happening with U.S. NDV vaccine manufacturers, PETA has submitted Freedom of
Information Act requests to the USDA requesting information on these
manufacturers' use of animal and non-animal methods. Unfortunately, companies
are allowed to censor this information on their reports to the USDA, and since
birds are excluded from the AWA, companies are not required to report any
information on the vaccine tests that are conducted on chickens.
C. tetani is a bacterium found in the gastrointestinal
of animals that causes tetanus, a
painful condition that leads to muscle spasms, respiratory failure, and death. Several
EU studies led to in vitro acceptance
of in vivo potency tests for
clostridial vaccines in the EU. In 2009, the CVB told PETA that it was taking
steps to implement in vitro testing of clostridial antigens and working toward an ELISA-based potency
test. However, PETA learned that this non-animal alternative would still
involve antibody production that uses mice in a painful and lengthy procedure. To produce large
quantities of an antibody, hybrid cells (cells fused together from both normal
and tumor cells) are injected into the abdomen of mice where the cells multiply
and produce antibody-filled fluid (ascites). This method is known as the "mouse
ascites method" of antibody production.
This method is so painful to mice
that it has been banned or restricted in Australia, Germany, Switzerland, the
Netherlands, and the United Kingdom, and the National Institutes of Health and
USDA both encourage the use of in
vitro methods instead. In a
2010 letter to the CVB, PETA asked the agency to
replace the use of the ascites method with available non-animal alternatives. The
CVB informed PETA that the majority of its ascites-produced antibodies are
stockpiles that, once exhausted, will be replaced using non-animal techniques.
Because the CVB anticipates that not all antibodies will be easily produced
using currently available non-animal approaches, PETA is staying on top of
current technologies and continues to encourage the CVB to examine the most
modern non-animal approaches for manufacturing specific antibodies.
When vaccines are
created using live viruses, there can be variations in the strength and safety
of each batch of the vaccine. To test for these variations, particularly for
veterinary vaccines, experimenters test the batches on the "target"
animal—the species for whom the vaccine is intended. Called "target animal
batch safety testing," or TABST, these tests use up to 10
times the recommended dose for live vaccines and twice the normal dose for
inactivated vaccines and can last up to 28 days. Large
numbers of animals are used in these tests, which can result in significant
pain and suffering.
In the 1990s, after questions
arose about the scientific and ethical aspects of these tests, a study of TABST
results was undertaken by the European Commission, which is responsible for the
administration and implementation of EU regulations, including for drug and
product safety. The result was a 2002 statement by the European Commission that
TABST as a routine part of batch testing was no longer relevant to ensure
safety. In 2005, a rule introduced in Europe took these findings into account
and allowed companies to forgo TABST if they proved that their batches were reliable.
a collaboration between PETA U.S. and PETA U.K., affiliate scientific
researchers discovered that the U.K. government was not ensuring that companies were using the
mechanism that allowed them to avoid animal testing and, in some cases, was even
charging companies to waive the tests. PETA U.K. pursued the issue with
ministers and officials, sending numerous letters and e-mails and holding two
meetings with government officials. The government responded by eliminating the
waiver fee and subsequently changing its policies to simplify the process
for companies applying to waive the tests, thus ensuring that veterinary
vaccine tests that can be avoided will no longer be approved.
The situation in the U.K. underscores the fact that regulatory acceptance of non-animal alternatives does not always mean that those alternatives will be used. In 2011, PETA U.S. and PETA U.K. scientists published a paper outlining a way to bridge the gap between the approval of non-animal batch potency tests by U.S. and U.K. regulatory bodies and the use of these tests by industry. The "bridging paradigm" proposed in the paper is an "information collection and dissemination matrix" that would hasten regulatory acceptance of non-animal testing methods (if they are not already accepted) and uptake of
these methods by industry through a series of steps involving petitions to
regulatory bodies, stakeholder alerts, media attention, and confirmation of the
use of the non-animal method by manufacturers. The bridging paradigm has been successful
in promoting and expanding the use of non-animal methods for batch potency
testing of erysipelas, leptospirosis, and pertussis vaccines in the U.S. and
veterinary vaccines in the U.K.
Another way in which PETA is working to reduce the number of
animals used in TABST is by working directly with the International Cooperation
on Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH), a trilateral (U.S.-E.U.-Japan) program aimed at
harmonizing requirements for veterinary product registration to reduce
duplicative animal tests. In preparation for a VICH meeting in November 2011,
PETA wrote to the head of VICH to ensure that the program prioritized
the development of harmonized guidelines for rabies vaccine tests that enable
the use of in vitro and other
non-animal test methods and that the Steering Committee kept PETA apprised of
the development of draft guidelines for in vitro extraneous agent
testing of avian viral vaccines.
Click here for more information
about PETA's efforts to ensure that federal government agencies are developing
and using non-animal testing methods to the fullest extent.
Click here to help support PETA's efforts to fund alternatives to cruel and archaic
Almost all of us grew up eating meat, wearing leather, and going to circuses and zoos. We never considered the impact of these actions on the animals involved. For whatever reason, you are now asking the question: Why should animals have rights? Read more.