Animal Testing in Commercial Products

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Brief Summary of Animal Testing in Commercial Products
Katie C. Galanes (2010)

Regulations and laws control the marketing of many commercial products, including drugs, cosmetics, pesticides, and food additives which could potentially be hazardous or pose a danger to human health or the environment.   A number of these commercial products are tested on animals.   Commercial products are tested on animals to ensure product safety for consumers.   For example, mascaras, shampoos, and perfumes are usually tested on the eyes of rabbits and oftentimes the eyelids of animals are forcefully held open for better absorption.

According to the federal 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.   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 oftentimes ineffective.

Controversy and debate surround animal testing, especially regarding commercial products.   Advocates of animal testing argue that no alternatives exist, and that a long-standing tradition of animal testing takes precedence over other methods.   In addition, advocates argue that public health and welfare depend upon animal testing and the elimination of animal testing would subsequently lead to the sale of unsafe or hazardous products.   On the other hand, those who are against animal testing argue for animal welfare and state that animals deserve consideration regarding their own well-being.   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.   Overall, the debate that exists surrounding animal testing is incredibly complex and controversial.

 

Overview of Animal Testing in Commercial Products
Katie Galanes (2010)

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.

 

Related articles

Some Thoughts on Animal Experimentation , David Favre, 2 Animal Law 161 (1996) .

Animal Experimentation: Lessons from Human Experimentation , Arthur Birmingham LaFrance, 14 Animal Law 29 (2007).

Opening The Laboratory Door: National and International Legal Responsibilities for the Use of Animals in Scientific Research--An Australian Perspective , Katrina Sharman, 2 Journal of Animal Law 67 (2006) .

National Institute of Mental Health (2002). Methods and Welfare Considerations in Behavioral Research with Animals: Report of a National Institutes of Health Workshop. Morrison AR; Evans HL; Ator NA; Nakamura RK (eds). NIH Publication No. 02-5083. Washington, DC: U.S. Government Printing Office.

Related cases

Alternative Research & Dev. Found. v. Veneman , 262 F.3d 406 (D.C. Cir. 2001). An animal rights foundation sought to have the definition of “animal” amended, so that birds, mice and rats used for research would not be excluded.  

 

Related laws

The Animal Welfare Act (AWA) - 7 U.S.C. § 2131 - 2159

California: CA CIVIL § 1834.9 - Alternative animal test methods; required use by manufacturers and contract testing facilities

New Jersey:  NJ ST 4:22-58 - 60 - Restrictions upon use of traditional animal testing methods for which there is an appropriate alternative testing method

New York: NY PUB HEALTH § 500 - 505a - § 505. Animal irritancy tests prohibited

Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research Report

 

Related Links

 

Web Center Links:

Animal Welfare Act (AWA) Topic Area

External Links:

Association for Assessement and Accreditation of Laboratory Animal Care International (AAALAC) - http://www.aaalac.org/

The Johns Hopkins Center for Alternatives to Animal Testing (CAAT) - http://caat.jhsph.edu/

 

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