This paper will examine the use of animals in toxicology testing. It begins with an examination of the most commons tests performed on animals within the commercial products industry. Next, the paper delves into the controversy and debate surrounding animal testing, and whether such a practice actually determines the safety of a product. In addition, the paper will examine and analyze existing laws that regulate animal testing and the federal agencies that manage the safety of commercial products. Last, some alternatives to animal testing are revealed and the future of animal testing is discussed.
I. Introduction
Commercial products are tested on animals to ensure product safety for consumers. The marketing of drugs, cosmetics, pesticides, food additives, and many other commercial products that could potentially be dangerous or hazardous to human health and/or the environment is controlled by regulations and laws. These regulations and laws were created to allow for the testing of animals in laboratories in order to determine whether the benefits of a particular substance outweigh its potential harms. Within the United States, manufacturers of commercial products are responsible for ensuring product safety for consumers. Kelly R. McNeal, Death: The Price of Beauty: Animal Testing and the Cosmetics Industry , American Bar Association Section of Environment, Energy and Resources, Law Student Division, Spring 2005, http://www.abanet.org/environ/committees/lawstudents/pdf/mcneal.pdf.
Furthermore, companies test commercial products and substances on animals to identify hazards and determine any adverse effects that may result from exposure to such commercial products and substances. Stacy E. Gillespie, A Cover-Girl Face does not have to begin with Animal Cruelty: Chapter 476 gives Legal Force to Alternative Testing Methods , 32 McGeorge L. Rev. 461, 461 (2001). This is also known as toxicology testing, and is defined as the “study of substances that are harmful or ‘toxic’ to living creatures.” Toxicology tests “identify hazards, determine adverse effects that will ensue from exposure to chemicals, and provide data estimating the quantitative exposure-response relationship for chemicals.” Id. at 463. During toxicology testing, tests can either be limited or short-term where exposure is acute or toxicology testing can be long-term where exposure to a chemical is chronic. Id. Regardless of the length of testing, toxicology tests measure the impact of chemical exposure on the health and mortality of animals. In theory, animal reactions to chemicals and commercial products emulate and represent the reactions of such on people.
This paper will examine the use of animals in toxicology testing. It begins with an examination of the most commons tests performed on animals within the commercial products industry. Next, the paper delves into the controversy and debate surrounding animal testing, and whether such a practice actually determines the safety of a product. In addition, the paper will examine and analyze existing laws that regulate animal testing and the federal agencies that manage the safety of commercial products. Last, some alternatives to animal testing are revealed and the future of animal testing is discussed.
II. History of Animal Testing in Consumer Products
Companies test commercial products on animals in a variety of ways. While animal testing was originally developed because of the use of animals in biomedical research, toxicology testing has become much more important. In the 20 th century, toxicology testing became vital to the safety of consumers as a number of companies began to sell products that were considered harmful or resulted in unforeseen side effects. For example, animal testing fully emerged in 1933 when a number of women went blind after applying mascara. See McNeal . Soon thereafter, the Food and Drug Administration (FDA) passed the Federal Food, Drug, and Cosmetic Act to protect consumers from unsafe or harmful commercial products. Id. Also, the expanding knowledge and development of chemicals used in commercial products led to a perceived need for animal testing. Two of the most commonly used methods of testing on animals include the Draize Eye-Irritancy Test and the Lethal Dose 50 Test.
A. The Draize Eye-Irritancy Test
The Draize Eye-Irritancy Test (Draize Test) was created by a toxicologist for the Federal Drug Association (FDA) in 1944. 32 McGeorge L. Rev. 461, 464. Originally, the Draize Test was intended to detect the potential harmfulness of a wide range of substances and products that could potentially come into contact with the human eye including, but not limited to, cosmetics, household products, industrial products, and possible chemical welfare agents. This particular test is almost exclusively performed upon rabbits. Traditionally, the rabbits are locked into holding devices with only their heads exposed. Ultimately, this method of strict confinement prevents the animals from scratching, clawing at eyes, or escaping. Id. Some common reactions observed after Draize testing include, but are not limited to: swollen eyelids, bleeding, swollen or inflammation of the iris, hemorrhaging, massive deterioration, ulceration or perforation of the cornea, and blindness. See McNeal. Since a great deal of those who perform these experiments believe anesthesia or pain relieving drugs interfere with test results, many animals are forced to “break their necks or backs in an effort to escape.” Id.
B. The Lethal Dose 50 Test
Another less commonly used method of animal testing is the Lethal Dose 50 Test (LD50). The LD50 Test is an experiment in which an animal is given a “dosage of the tested chemical necessary to kill fifty percent of the test animals.” 32 McGeorge L. Rev. 461, 465. Oftentimes, the LD50 Test is used on rats or mice. See McNeal . The LD50 Test “involves placing chemicals on the animals’ raw, shaved skin and covering the skin with adhesive plaster.” Tested animals may suffer from “irritated or inflamed skin, bleeding, or bloody scabs.” Other more severe side effects that animals may suffer as a result of the LD50 Test include, but are not limited to: “severe abdominal pain, muscle cramps, convulsions, vomiting, diarrhea, gastrointestinal ulcers with bleeding, loss of kidney functioning, and other painful or distressing conditions.” Id. The LD50 Test aids federal regulators by determining the proper safety precautions necessary in order to ensure adequate product manufacturing, transport, use and disposal. 32 McGeorge L. Rev. 461, 465. Historically, the LD50 Test was one of the first animal testing methods used to determine the toxicity of a chemical or product. See McNeal .
Despite the fact that the LD50 Test may test chemicals or products that are not very toxic, injury or death may occur from other complications involved during the testing process, including death from the sheer volume of chemical or product forced into an animal’s system. Id. While the LD50 Test is not as widely used as it once was, this method of testing still occurs but usually with a fewer number of animals being tested. 32 McGeorge L. Rev. 461, 465. Ironically, any animals that survive the LD50 Test are immediately euthanized while the tissues of all the other animals involved are examined pathologically. See McNeal .
C. What Constitutes “Animal Testing”
When testing cosmetics on animals, all of the following practices are included:
(1) testing a finished cosmetic product on animals; (2) testing individual ingredients of cosmetic products on animals; (3) testing any combination of ingredients on animals; (4) contracting a third-party company to perform any of the above tests; or (5) using a subsidiary or third-party company to perform any of the above tests in countries where animal testing is not banned.
See McNeal . As such, animal testing not only includes the direct testing performed by the commercial product manufacturers, but also consists of any testing on animals that has been contracted out to third-party companies. Clearly, some companies form contracts with third-party entities to perform testing on animals so as to avoid any direct association with the practice of testing on animals. Id. One perceived reason companies do this is to circumvent any involvement with animal testing, so consumers are kept in the dark as to the fact that some consumer products are tested on animals.
Moreover, a number of toxicity tests are performed in order to determine the safety of chemicals, food additives, pesticides, pharmaceuticals, and certain nanomaterials. The Humane Society of the United States, Questions and Answers About U.S. Animal Testing of Chemicals, available at http://www.hsus.org/web-files/PDF/ARI/chemicals.pdf ; The Humane Society of the United States, Questions and Answers About U.S. Animal Testing of Food Additives , available at http://www.hsus.org/web-files/PDF/ARI/additives.pdf ; The Humane Society of the United States, Questions and Answers About U.S. Animal Testing of Pesticides , available at http://www.hsus.org/web-files/PDF/ARI/pesticides.pdf ; The Humane Society of the United States, Questions and Answers About U.S. Animal Testing of Pharmaceuticals , available at http://www.hsus.org/web-files/PDF/ARI/pharmaceuticals.pdf ; The Humane Society of the United States, Questions and Answers About U.S. Animal Testing of Nanomaterials , available at http://www.hsus.org/web-files/PDF/ARI/nano.pdf . Animal testing encompasses a wide array of testing methods and commercial entities, and what constitutes animal testing may not always be clear to the consumer public.
III. The Debate
Controversy and debate surround animal testing, especially with regard to commercial products. Critics of animal testing argue in support of animal welfare and claim that animals, at the very least, deserve consideration when it comes to their own well-being. 32 McGeorge L. Rev. 461, 465. Additionally, animal advocates argue that scientific test results can never truly be accurate or reliable when gathered from an animal that has been abused, neglected, or mistreated. Certainly, the stress of laboratory care and handling can greatly impair the health of said animals and ultimately skew or negatively affect the outcome of scientific testing. Dije Ndreu, Keeping Bad Science Out of the Courtroom: Why Post-Daubert Courts are Correct in Excluding Opinions Based on Animal Studies from Birth-Defects Cases , 36 Golden Gate U. L. Rev. 459, 467-68 (2006).
As time progresses and technology advances, many of the tests performed upon animal subjects are being scientifically questioned. 32 McGeorge L. Rev. 461, 464. Most importantly, the results of animal testing cannot be properly applied to human physiology and consequently, animal responses to testing will significantly differ from human responses. Id. According to a number of sources, “extrapolation from animal experiments to humans has distinct disadvantages.” 36 Golden Gate U. L. Rev. 459, 467. The disadvantages associated with extrapolating data from animal experiments to human ones extend across the field of science and testing. Test results from numerous toxicology tests and commercial products testing change drastically from one species of animal to another, and in no way is an indicator of how people would react to a chemical or product. See McNeal . Specific disadvantages referenced include: differences in proper dosage levels, animal and human anatomy, absorption, susceptibility, excretion, metabolism of a substance or chemical, and finding a similar way to administrate substances or chemicals. Id. at 467-68. Animal advocates that argue against animal testing also reveal that a majority of tests performed on animals “do not provide protection for consumers from unsafe products, but rather they are used to protect corporations from legal liability.” See McNeal . A majority of companies dealing with commercial products traditionally perform toxicology and safety testing on animals to ensure they are not liable for any injury or death associated with said commercial products. Certain entities, such as corporate lawyers attempting to protect their company from liability if a consumer is harmed or killed as well as insurance companies, continue to endorse the use of animal testing for the same reason. Id.
While inherent problems exist when performing tests on animals, advocates of animal testing argue that no adequate alternatives exist and the long-standing tradition of testing upon animals has worked thus far. 32 McGeorge L. Rev. 461, 461. Several scientists, researchers, and policy-makers tend to “justify extrapolation from animal studies simply on the basis that it is often the only information available.” 36 Golden Gate U. L. Rev. 459, 469 . Moreover, advocates state that animal testing succeeds in determining the safety of products and there are limitations to any alternatives that do exist. 32 McGeorge L. Rev. 461, 465. For example, animal testing may be a preferred method of testing because researchers and scientists can “isolate the effects of exposure and control all aspects of the animals’ lives.” 36 Golden Gate U. L. Rev. 459, 468 .
Furthermore, advocates argue that public health and welfare depend upon animal testing and the elimination of animal testing would subsequently lead to the manufacture and sale of unsafe or hazardous products. Laura Donnellan, Animal Testing in Cosmetics: Recent Developments in the European Union and the United States , 13 Animal Law 251 (2007 ). At the forefront of these debates dealing with animal issues, many argue that advancing human interests outweighs any right or interest of an animal.
IV. The Federal Level: The Animal Welfare Act (AWA)
The Animal Welfare Act (AWA) is the only federal law that regulates the treatment of animals used in testing and research and is known as the minimum acceptable standard. Animal and Plant Health Inspection Service, Animal Welfare Act Information , April 26, 2010, available at http://www.aphis.usda.gov/animal_welfare/awa_info.shtml . Over time, the AWA has been amended a total of six different times. On the surface, the AWA applies to laboratory animal testing because the law regulates dealers who obtain and handle animals that are sold to laboratories as well as research facilities. Id.
A. Standards of Care and the IACUC
According to the AWA , certain species of animals used in testing are owed proper housing, treatment, veterinary care, food and water. David Favre, Some Thoughts on Animal Experimentation , 2 Animal Law 161, 1996 . Under the AWA, any individual scientist or animal testing institution that receives federal funding is required to institute and maintain an Institutional Animal Care and Use Committee (IACUC). The IACUC is responsible for ensuring that laboratories and institutions testing on animals comply with the regulations within the AWA. Id. The United States National Institutes of Health (NIH) Office of Laboratory Animal Welfare is required by law to develop policies which explain the role of the IACUC and enforce the standards of the Guide for the Care and Use of Laboratory Animals, which was published by the Institute for Laboratory Animal Research. Institute of Laboratory Animal Resources; Commission on Life Sciences; National Research Council, Guide for the Care and Use of Laboratory Animals , 1996, available at http://www.nap.edu/openbook.php?isbn=0309053773 .
However, while the AWA exists to protect animals, a vast number of disadvantages and drawbacks exist for animals being used in commercial product and toxicity testing. An amendment to the AWA, the Farm Security Act of 2002, excludes a vast majority of animals used in research from protections provided in the AWA. See Favre . The Farm Security Act of 2002 excludes a majority of the animals used in testing facilities. While animals from pounds and animal shelters, strays, and wild animals used in animal testing are covered by the AWA and afforded protection under the law, animals purposely bred to be used in animal testing are not covered by the AWA and remain unprotected under the law. Most importantly, “the AWA only applies to six species of animals used in experiments: dogs, cats, nonhuman primates, rabbits, hamsters, and guinea pigs” but fails to protect “rats, mice, birds, fish, or farm animals.” Darian M. Ibrahim, Reduce, Refine, Replace: The Failure of the Three R’s and the Future of Animal Experimentation , 2006 U. Chi. Legal F. 195, 213-14 (2006). Rats, mice, birds, and fish are believed to account for as much as 97% of the total percentage of animals used in testing. Id. at 214. As such, a majority of animals used in testing are not covered or protected by the AWA and are owed no duty of care when used for testing purposes.
Another important exception to the protections offered under the AWA exists when a researcher determines it is not scientifically necessary or would negatively affect the results of testing. 32 McGeorge L. Rev. 461, 468-69. As a result, researchers and scientists retain a great deal of oversight regarding the use of tranquilizers and anesthetics in animal testing. Id. Anesthesia or pain relieving drugs may not be administered to the animals when researchers believe these substances interfere with test results. See McNeal . In addition, the AWA fails to define humane care and treatment of animals within the act itself. This lack of definition causes a great deal of confusion as to what degree of care and treatment an animal used in testing is legally owed. 32 McGeorge L. Rev. 461, 468. Another drawback exists in that the AWA focuses mainly on where animals are to be obtained for use in animal testing, versus focusing on the procedures and processes used during commercial product and toxicity testing and enforcing proper treatment of animals. Id. at 468-69. The AWA fails to require procedures which could prevent or lessen pain or suffering upon the animals, and does not prevent unnecessary testing. Id.
B. Application of the “Three R’s”
A process known as the “Three R’s” has been developed and incorporated into the AWA . The process includes reduction , refinement , and replacement of animal testing. The “Three R’s” specifically requires “researchers to reduce the number of animals used in experiments, refine experimental procedures to minimize animal pain and suffering, and replace animal subjects with non-animal alternatives when scientifically feasible.” 2006 U. Chi. Legal F. 195, 196. While a significant amount of disappointment has been associated with the implementation and enforcement of the “Three R’s” method, it has played a significant role in animal testing.
First, reduction refers to scientific improvements that would allow for the minimization of the number of laboratory animals used in any given experiment. Id. at 198. Reduction has obvious economic limitations since most laboratory animals, such as rats and mice, significantly cost less than re-designing an entire research facility or lab. Some of the scientific improvements that would allow for reduction include “controlling variance and better design and analysis of experiments.” In order to refine animal testing, improvements that minimize or eventually eliminate the suffering of animals must be implemented. Some common methods of refinement would include, “analgesia (local anesthesia), administering substances through inhalation rather than injection, and restraining animals after experimentation.” One of the greatest ways to implement refinement would be to avoid death of the animals at the conclusion of testing. Id. at 199. Last, replacement includes the development of non-animal alternatives which would ultimately replace animals and eliminate their use in testing altogether. Id.
It should also be noted that a number of federal agencies responsible for consumer product safety, including the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC) and the Occupational Safety and Health Administration (OSHA), have attempted to implement the “Three R’s” theory. At the same time, however, these federal agencies remain dependent upon animal testing when determining whether a substance or commercial product is safe for consumers. For example, “the EPA requires animal testing for substances classified as ‘pesticides’ under the Toxic Substances Control Act, and the CPSC requires animal testing to determine whether substances must be labeled as ‘highly toxic’ under the Federal Hazardous Substances Act.” This inherent tension emphasizes the deficiencies of the “Three R’s” theory and the indecisiveness of federal agencies to implement a clear cut policy. For instance, the “Three R’s” theory in and of itself does not prevent unnecessary experimentation or animal testing. Id. at 210. It also fails to challenge the purpose of using animals in testing or experimentation, nor can the theory prevent questionable commercial products testing or toxicity testing. Id. In essence, without change from the listed federal agencies that require animal testing, the “Three R’s” theory remains an ideal rather than an implemented practice or policy.
V. Federal Agencies and Animal Testing
The federal agencies which oversee the sale and safety of consumer products include: the FDA, the EPA, the CPSC and OSHA. Id. at 208. Each federal agency plays a role in permitting the use of animal testing as an appropriate method to determine product safety, but the most important agency to discuss is the FDA.
A. Federal Labeling Standards
The FDA concerns itself with proper labeling of commercial products and assuring that such products are safe for consumers. U.S. Food and Drug Administration, Animal Testing , May, 31, 1999, available at http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductTesting/ucm072268.htm . For example, the FDA enforces the Federal Food, Drug, and Cosmetic Act which was passed in 1938 to protect consumers from unsafe commercial products. See McNeal . However, the Act does not require the use of animal testing to determine product safety or “FDA premarket approval.” See U.S. Food and Drug Administration, supra . Instead of specifically requiring animal testing, the FDA has “consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products.” See Id. While the FDA does not specifically require animal testing, the federal agency does promote animal toxicity data as a “de facto gold standard to settle safety issues” when dealing with commercial products. See McNeal .
B. Moving Away from Endorsed Animal Testing
Within the past several years, a movement away from using animals in testing has begun. Moreover, some federal agencies now explicitly allow for alternative testing methods used in toxicity and commercial product testing. 2006 U. Chi. Legal F. 195, 208-09. Although a movement away from animal testing has begun, eliminating animal testing any time soon seems unrealistic. Federal agencies continue to allow commercial products manufacturers and industries to test on animals. As a result, proper enforcement of animal welfare statutes that specifically refer to animals used in testing, such as the AWA , becomes imperative. Since the AWA fails to protect a majority of the animals used in testing, however, a change from the legislature will be required to implement any kind of enforceable welfare standards. If the legislature decides to execute such a change, federal agencies will then need to support these findings and enforce animal welfare statutes in order to protect animals used for testing.
VI. Application of State Anti-Cruelty Laws to Animal Testing
While the AWA is limited in terms of application and enforcement, a few states have addressed the concern of animal testing. It should be noted that nearly all states exclude animal testing from the purview of their anti-cruelty laws. While some state anti-cruelty laws exist, most laboratory research and testing facilities are exempted from such statutes. 32 McGeorge L. Rev. 461, 469-70. For example, the Illinois animal cruelty statute specifically states that “institutions operating under federal license to conduct laboratory experimentation utilizing animals for research or medical purposes are . . . exempt from the provisions” of the animal cruelty statute. See 510 ILCS 70/10 . Another problem state anti-cruelty laws face is that sporadic enforcement ultimately renders state statutes ineffective. 32 McGeorge L. Rev. 461, 469-70. Most often, “enforcement only occurs through public prosecution which typically provides redress for only the most egregious practices.” Id. at 470. Some states, including California , New York , and New Jersey , have statutes that prohibit the use of animal testing when an appropriate alternative testing method exists and has been validated by the relevant federal agency or specific agency responsible for regulating testing within that commercial area or activity. See , for example, Restrictions Upon Use of Traditional Animal Testing Methods for Which There is an Appropriate Alternative Testing Method , N.J. Stat. Ann. § 4:22-59 (2007) , and Animal Irritancy Tests Prohibited , N.Y. Public Health Law § 505 (2009) .
VII. Industry Self-Regulation and Standards
In addition to the AWA , federal regulations, and state anti-cruelty laws relating to laws and regulations governing animal testing, the commercial products industry has its own views on standards as well. Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), a private nonprofit association, is regarded by the commercial products industry as the “gold standard” in terms of standards used for animal testing. See http://www.aaalac.org/ . A research laboratory or scientist can obtain accreditation through a prearranged AAALAC site visit and program evaluation. Once accreditation is obtained for animal testing, a site visit by the AAALAC and a program evaluation must be done once every three years in order to maintain accreditation. The AAALAC intends to ensure compliance with the standards established in the Guide for the Care and Use of Laboratory Animals, as well as other national and local laws relating to animal welfare. Id.
While a majority of commercial products industries fail to disclose the methods of testing they use on animals or the standards used to regulate such testing, some corporations are taking steps to distance themselves from animal testing. As the consumer public becomes more aware of animal testing, companies that develop and sell commercial products are beginning to realize the implications and effect animal testing can have on the public. The Coalition for Consumer Information on Cosmetics (CCIC) runs a program that offers a list of commercial products companies that have adopted a “Corporate Standard of Compassion for Animals.” The Humane Society of the United States, Questions and Answers About Cosmetic and Product Testing , October 7, 2009, available at http://www.humanesociety.org/issues/cosmetic_testing/qa/questions_answers.html . This industry standard allows the consumer public to purchase commercial products from companies that do not test on animals at any stage of product development. As such, the public can be assured that the commercial products they are purchasing have not been tested on animals.
VIII. The Future of Animal Testing
As is evidenced by several states’ legislative responses to animal testing as well as the “Three-R’s,” there is a movement afoot to move away from animal testing. Whether this is out of a concern for animal welfare or merely a political response to public outcry, the result is the same. In lieu of animal testing, some consumer product manufacturers are now pursuing in vitro testing and human replacement models. Moreover, California has even forced industry through punitive legislation to use other forms of product testing ( See , West's Ann. Cal. Civ. Code § 1834.9(d) ). Through advances in technology and science, a number of alternatives to animal testing have been created. The Humane Society of the United States, Alternatives to Animal Tests , March 2, 2010, available at http://www.hsus.org/animals_in_research/animal_testing/alternatives.html .
A. In Vitro Testing
In vitro testing occurs when a “biological process [is] made to occur in a laboratory vessel or other controlled experimental setting rather than within a living organism.” 32 McGeorge L. Rev. 461, 466. In vitro testing is a recent development in the fields of cellular and molecular biology and computer bioanalytical modeling techniques, which allows scientists and researchers to test on scientifically cultured human cells and tissues instead of living animals. Id.
B. Replacement Techniques
In addition to in vitro studies, replacement techniques include “physicochemical studies, computer modeling, microbiological studies, clinical and epidemiological studies, and autopsy.” 2006 U. Chi. Legal F. 195, 199-200. While human volunteers may not be the most advanced scientific alternative method developed, a clinical skin patch test conducted on human skin has been shown to produce more accurate and superior skin irritation data. See McNeal. Another common alternative method to animal testing includes searching databases of tests that have already been completed, in order to avoid any kind of duplication. See McNeal . However, one must proceed with caution when developing alternatives to animal testing because scientific validity may be questioned. (For a complete list of all scientifically validated alternatives to animal testing, see http://www.alttox.org/ttrc/validation-ra/validated-ra-methods.html ) As such, a means of replacement must replicate the scientific validity established by animal testing in an overall sense, and must be of particular interest to researchers and scientists. 2006 U. Chi. Legal F. 195, 201.
C. Punitive Measures by States to Force Alternative Testing Methods
In California, Chapter 467 (the number of the enacting legislation) was passed in 2000 and requires manufacturers and contract testing facilities to use alternative testing methods when the alternative method is scientifically approved and recommended by the Inter-Agency Coordinating Committee for the Validation of Alternative Methods (ICCVAM), and the alternative method is adopted by the appropriate federal regulatory agency. West's Ann. Cal. Civ. Code § 1834.9 . Effectively, Chapter 467 creates a limited ban on animal testing when a viable, federally approved and adopted alternative exists. 32 McGeorge L. Rev. 461, 462-63. Moreover, Chapter 467 allows injunctive measures and fines for relief against companies and businesses that violate said legislation. Id. at 463.
While Chapter 467 is an enormous step forward for animal welfare advocates who disagree with animal testing, certain drawbacks exist. For example, animal advocate groups are not allowed to bring civil actions against companies and business allegedly in violation of alternative testing mandates because of standing. Id. at 471. Standing issues are created for animal advocate groups because of the “real party interest” requirement in litigation. Here, the real party interest that exists is the actual animals involved and, as a result, no third party can bring an action against alleged violators on their behalf. No criminal penalties can legally be brought against alleged violators under Chapter 467. Id. at 473-74. Pursuant to Chapter 467, only civil penalties are permitted. Furthermore, the Draize Test is not specifically prohibited and companies are still permitted to use this method of animal testing. Id.
D. Animal Testing and Trade Implications
Throughout Europe, similar alternative testing methods are being developed and a number of countries within Europe have effectively banned some forms of animal testing in association with commercial products and toxicology. See McNeal . As such, the United States must consider certain forms of trade disruption when it comes to trading commercial products that have been tested on animals. While the United States may continue to test on animals in order to determine product safety for a number of commercial products, the European Commission has the discretion to ban any such products. As a result, the United States may be ultimately forced to follow in Europe’s footsteps in developing other alternative methods of testing, without using animals, if the nation wants to continue trading particular commercial products with such countries. Id. Cooperation amongst countries in developing mutually acceptable alternatives to animal testing may be a step toward a future without animal testing on commercial products and provide a more free trade environment.
E. Developed Scientific Alternatives to Animal Testing
Johns Hopkins Center for Alternatives to Animal Testing (CAAT), founded in 1981, was created in order to search and develop alternatives to animal testing while maintaining the underlying process of evaluating the overall safety of commercial products. See McNeal. The FDA has stated that it encourages and values the “research, development, and validation of alternative methods” the CAAT has accomplished. An alternative testing method the CAAT has developed to avoid use of the Draize eye irritancy test is Eytex. Id. Eytex is an alternative testing method that evaluates eye irritancy of a protein alteration system by using an in vitro, or test tube, procedure. Fascinatingly, a vegetable protein extracted from a bean mirrors the reaction a human cornea would have to a foreign substance within the eye. Similarly, Skintex (which uses pumpkin rinds to mirror the reaction human skin would have to a foreign substance) was an in vitro test method developed as an alternative to the Draize skin irritancy test. Other popular alternative methods that have been scientifically validated and accepted include Episkin, EpiDerm, and Epipak, which all test cultures of human skin cells to determine potentially harmful substances. While the Fixed Dose Procedure, the Acute Toxic Class Method, and the Up and Down Procedure have all been developed as alternatives to the LD50 test, all of these alternative methods continue to use animals as test subjects. Id. As such, a great deal of reduction in the number of animals utilized in research and testing is achieved; however, replacement methods must still be further developed. Within the United States, the ICCVAM has validated both the Corrisitex Test and the Murine Local Lymph Node Assay Test (LLNA) as alternative methods of testing consumer products without the use of animals. See Donnellan . Both of these sophisticated non-animal test methods determines skin corrosivity and irritation. Id.
In terms of toxicology testing, bioscience is a newly developed technique being used “to uncover the manner in which environmental agents perturb pathways to cause toxicity.” Board of Environmental Studies and Toxicology; Institute for Laboratory Animal Research, Toxicity Testing in the 21 st Century: A Vision and a Strategy , 2007, available at http://books.nap.edu/openbook.php?record_id=11970&page=36 . Said pathways may eventually reveal “adverse health effects when sufficiently perturbed” and are commonly known as toxicity pathways. Other common forms of alternatives regarding toxicology testing include quantitative high-throughput assays. Quantitative high-throughput assays are employed to “expand the coverage of the universe of new and existing chemicals that need to be evaluated for human health risk assessment.” Moreover, the new assay can lead to more enhanced and valuable test results since the alternative can test a wider range of concentrated doses, “including those representative of human exposure.” Id.
IX. Conclusion
Looking forward, whether or not alternative methods of testing are used to determine the safety and toxicity of commercial products will ultimately depend upon cost effectiveness, scientific validity, and reliability of results. While certain laws and regulations, such as the AWA and many state animal cruelty laws, appear ineffective at monitoring and ensuring the welfare of animals used in research, a current developmental trend toward alternatives to animal testing has recently strengthened. Some states have begun to require the use of alternatives when certain requirements are met, and scientific development of more advanced alternatives continues. Unfortunately, the general public remains unaware, uninformed, and uneducated about animal testing methods with regard to a majority of commercial products. A great deal of information relating to animal testing remains hidden, since commercial products companies have an enormous economic interest in preserving animal experimentation and maintaining public ignorance. Evidently, progress has been made to develop scientifically validated alternatives to animal testing; however, without legislative or public pressure to implement these changes, the commercial products industry continues its 75-year legacy of animal testing.