Full Title Name:  Overview of Animal Testing in Commercial Products

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Katie C Galanes Place of Publication:  Michigan State University College of Law Publish Year:  2010 Primary Citation:  Animal Legal and Historical Center

The overview summary introduces the topic of animal testing within the commercial products industry. The article introduces a number of federal agencies responsible for monitoring and regulating animal testing. In addition, the overview explores the Animal Welfare Act along with some of the most traditional animal testing methods. The overview also reveals some recently developed animal testing alternatives and attempts to further explain the complex controversy that surrounds animal testing.


In the United States, the Food and Drug Administration (FDA) determines whether or not certain commercial products are determined as safe for consumer use by enforcing the Federal Food, Drug, and Cosmetic Act.   Other federal agencies that oversee the sale and safety of consumer products include, but are not limited to, the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA).   Many regulations and laws control the marketing of commercial products, including drugs, cosmetics, pesticides, and food additives which could potentially be hazardous or pose a danger to human health or the environment.   Oftentimes, commercial products are tested on animals to ensure product safety for consumers.  

According to the Animal Welfare Act (AWA), animals that are used in testing are owed proper housing, treatment, veterinary care, food and water.   However, a vast majority of animals used in research are excluded from the protections provided for in the AWA as a result of the Farm Security Act of 2002.   Specifically, all animals that are purposely bred for testing are not covered under the AWA and only covers dogs, cats, nonhuman primates, rabbits, hamsters and guinea pigs.   Overall, 97% of the animals actually used as test subjects, including rats, mice, birds, fish, and farm animals, are not covered under the AWA.   Moreover, an exception to the protections of the AWA exists when a researcher determines it is not scientifically necessary or would negatively affect the results of testing.   As such, many of the laws and regulations that exist, including the AWA and many state anti-cruelty laws, are largely ineffective.

When determining the safety of a commercial product, companies use a variety of testing methods.  Specifically, toxicology tests identify hazardous chemicals and commercial products.  Toxicology testing uncovers any adverse effects that may result from exposure to certain chemicals or commercial products, and provides quantitative exposure-response data.  Two of the most traditional forms of animal testing are the Draize Eye-Irritancy Test (Draize Test) or the less commonly used Lethal Dose 50 Test (LD50 Test).   Certain federal agencies require animal testing to determine the safety of a product, while others do not.   For example, the EPA requires animal testing for substances classified as pesticides under the Toxic Substances Control Act.   On the other hand, the Federal Food, Drug, and Cosmetic Act enforced by the FDA does not require the use of animal testing to determine product safety or premarket approval.   However, the FDA does allow manufacturers of commercial products to employ whatever testing method is appropriate and effective for substantiating the safety of a product.  

Within the commercial products industry, animal toxicity data tends to be the de facto standard for settling safety issues when dealing with said products.   Also, the commercial products industry has its own gold standard when it comes to animal testing.   Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), a private nonprofit association that ensures compliance with standards and laws relating to animal welfare, is regarded as customary within the commercial products industry.   Obtaining accreditation from the AAALAC requires a prearranged site visit and a program evaluation.   In order to maintain such accreditation, a site visit and program evaluation must take place once every three years.

A process known as the “Three R’s” has been developed, incorporated into the AWA, and adopted by federal agencies nationwide.   The “Three R’s” specifically requires researchers to reduce the number of animals used in experiments, refine experimental procedures to minimize pain and suffering, and replace animal subjects with non-animal alternatives when feasible.  While a significant amount of disappointment has been associated with the implementation and enforcement of the “Three R’s” theory, it has played a significant role in animal testing.   Moreover, the same federal agencies that adopted the “Three R’s” methodology also remain dependent upon animal testing when determining whether a substance or commercial product is safe for consumers.

Within the past decade, many alternatives to animal testing have been developed.   The most common alternatives include: in vitro testing, physicochemical studies, computer modeling, microbiological studies, clinical and epidemiological studies, and autopsy.   In vitro studies allow scientists and researchers to test on scientifically cultured human cells and tissues instead of living animals.   Other alternatives to animal testing include searching databases of tests already completed in order to avoid duplication as well as human test subjects.   While testing on human volunteers may not be the most advanced scientific alternative, skin patch tests conducted on human subjects has been shown to produce more accurate and superior skin irritation data versus data collected when testing on animal subjects.  

Controversy and debate surround animal testing, as advocates of animal welfare attempt to argue against scientists who use animals to ensure the safety of commercial products.   A majority of researchers argue that no alternatives to animal testing exist, and that a long-standing tradition of animal testing takes precedence over other any other testing methods developed.   In addition, the commercial products industry argues that public health and welfare depend upon animal testing and the elimination of said testing would subsequently lead to the manufacture and sale of unsafe or hazardous products.   On the other hand, animal welfare advocates argue for the protection of animals and believe animals deserve consideration in regards to their well being throughout the testing process.   Furthermore, animal advocates argue that scientific test results cannot truly be accurate or reliable when originating from an animal that has been mistreated, neglected, or abused.   As time passes and technology further develops, many of the tests performed on animal subjects are being scientifically questioned and new alternatives will need to be developed in order to create an improved scientific validity.   In sum, the debate that exists surrounding animal testing is incredibly complex and controversial as animal welfare advocates and researchers argue over the proper treatment and care of animals, the scientific validity of testing, and the overall safety of commercial products.


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