Full Title Name:  A Cover-Girl Face does not have to Begin with Animal Cruelty: Chapter 476 Gives Legal Force to Alternative Testing Methods

McGeorge Law Review Winter, 2001

Casenote

Review of Selected 2000 California Legislation

Animal Testing

A COVER-GIRL FACE DOES NOT HAVE TO BEGIN WITH ANIMAL CRUELTY: CHAPTER 476 GIVES LEGAL FORCE TO ALTERNATIVE TESTING METHODS

Stacy E. Gillespie

Copyright (c) 2001 by McGeorge School of Law, University of the Pacific; Stacy E. Gillespie (reprinted with permission)

Code Section Affected

Civil Code § 1834.8 (new).

SB 2082 (O'Connell); 2000 Stat. Ch. 476

“The morality of an act cannot be determined by a photograph.”1

I. Introduction

Or can it? The context of a picture usually clarifies the morality of an act. For instance, many of us have seen the seemingly unconscionable pictures of rabbits being used to test cosmetic products: eyelids held open with clips to better absorb the latest shampoo, makeup, or perfume.2 Often, there is no relief from the tested solution until the eyes are destroyed.3 Confronted with these alarming images, justification of such animal testing is difficult, if not impossible, for a product such as a new and improved mascara. However, consumers have tended to turn a well-fashioned eye.4 The cosmetic5 industry grosses twenty-five to thirty billion dollars *462 annually.6 In the end, only by revealing the potentially defective behavior, or contextualizing the act, may the systemic repercussions be understood.7

Often, many traditional animal tests are duplicative, and hence unnecessary, as most chemicals used in the personal care industry have already been tested, and the results are merely stored in databases.8 In fact, some companies within the cosmetic industry enjoy international success without ever having tested their products on animals.9 Also, some corporations are developing alternative testing on their own, and are eagerly awaiting legislation to streamline regulatory mandates to include these alternative methods.10 Even so, many manufacturers continue traditional animal testing despite the existence of federally approved alternative tests.11 Thus, animals continue to be tested on and killed in procedures that are proving to be unnecessary.

Chapter 476 responds to this needless animal testing.12 It requires manufacturers and contract testing facilities13 to conduct alternative testing14 when certain *463 conditions are met: the alternative test methods must be scientifically approved and recommended by the federal Inter-Agency Coordinating Committee for the Validation of Alternative Methods15 (ICCVAM), and subsequently adopted by the appropriate federal regulatory agency. Finally, Chapter 476 creates injunctive measures and fines to be pursued against business entities in violation of the new law.16

II. Background

A. Toxicity Testing

Toxicology is the study of substances that are harmful or “toxic” to living creatures.17 Toxicological tests evaluate the impacts of chemical exposure on the health and mortality of animals.18 The tests can be of limited, or acute, exposure, or of long-term, or chronic exposure.19 Toxicity tests identify hazards, determine adverse effects that will ensue from exposure to chemicals, and provide data estimating the quantitative exposure-response relationship for chemicals.20

*464 1. Product Injury—A Need for Toxicological Testing

In the 1920s, the Journal of the American Medical Association reported product injury statistics which demonstrated that insufficient eye-irritation testing could translate into distressing outcomes for consumers.21 For example, Lash-Lure, an eyebrow and eyelash dye, reportedly caused blindness, disfigurement, and at least one death to consumers who used the product.22 Another product, Inecto Rapid Notox, a hair dye, reportedly injured thirty-seven consumers, causing injuries ranging from swelling of the face, head, and larynx, to permanent blindness.23 This dire consumer climate created a demand for increased toxicity testing of consumer products.

2. A Consumer Protection Response

In 1944, John Draize, a toxicologist for the Federal Drug Association (FDA), responded to this injurious consumer climate by developing the Draize eye-irritancy test.24 This test was intended to detect the potential harmfulness of a wide range of products that could potentially come into contact with the human eye: cosmetics, household products, industrial products, and even chemical warfare agents.25 The procedure of the Draize test is infamous: it is almost exclusively performed on rabbits, who are traditionally locked into holding devices, with only their heads exposed, to prevent them from clawing at their eyes or from escaping.26

Since its inception, there has been widespread opposition to the Draize Test.27 The humane criticisms are evident, but its application to human physiology and its varying test results have also been scientifically questioned.28 Nonetheless, the *465 Draize test has been widely performed, and many toxicologists are hesitant to turn to alternative methods because the test succeeds in determining human eye irritants.29 This hesitancy is primarily due to the relative limitations of in vitro30 testing,31 and because long-standing and lucrative habits are often hard to break.32

Another antiquated toxicity test is the Lethal Dose 50 (LD50).33 LD50 refers to the dosage of the tested chemical necessary to kill fifty percent of the test animals.34 In the past, information gained from these tests aided federal regulators in determining what safety precautions were necessary regarding product manufacturing, transport, use and disposal.35 Today, the test is not as widely used.36 Further, when LD50 is used by academics, industry, or government agencies, they use fewer animals for each test.37 Rather than using the traditional fifty to one hundred test animals, ten are usually used.38

B. Animal Advocates

For several decades, animal advocates39 have spurred a movement against cruelty towards animals.40 One primary philosophical basis for animal welfare is not that animals should be treated as equal to people, but that their interests should be given equal consideration.41 Logically, “[e]qual consideration for different beings *466 may lead to different treatment and different rights,”42 but, at the very least, equal consideration requires concern for the well-being of animals.43 The difference of opinion concerning the degree of equal consideration can be seen even within the “animal rights movement,” where there exists a wide berth of philosophical and strategical differences.44 However, a common thread among them has historically been opposition to animal testing in laboratories.45

C. The Development of Alternative Testing

Increased concern for animal welfare spurred the quest for alternative testing, and the recent availability of in vitro testing makes alternative testing a reality.46 In vitro testing is defined as “a biological process made to occur in a laboratory vessel or other controlled experimental setting rather than within a living organism ....”47 Its availability has flourished with exponential advances in the cellular and molecular biology fields, and with the development of computer bioanalytical modeling techniques.48 Accordingly, in response to both public pressure and laboratory advances, some cosmetic companies have reduced reliance on animals for testing.49 Some companies are even eagerly awaiting the necessary regulatory *467 approval for alternative test methods, so that animal use for product testing may be reduced.50

D. The Inter-Agency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)

In 1997, the National Institute of Environmental Health Sciences established the ICCVAM in response to a federal mandate51 to create a uniform procedure for approving alternative methods of product safety testing, including those which use fewer or no animals.52 Pursuant to that mandate, ICCVAM has published its protocol for federal regulatory acceptance of alternative tests.53 The goal of ICCVAM is to improve product safety testing by achieving better predictive toxicity levels of chemicals and products, to reduce or eliminate the use of animals,54 and to reduce or eliminate the use of animals in acute or chronic toxicity testing.55

ICCVAM is made up of federal regulatory and research agencies that are involved with toxicity test methods for consumer product testing.56 The panel conducts extensive scientific reviews of proposed alternative tests and engages in public deliberations.57 After a test method has been approved, ICCVAM forwards its recommendations to federal regulatory agencies for subsequent review and potential adoption.58 If adopted,59 the appropriate federal regulatory agency will specify the chemicals and products for which the alternative test may be used.60 However, although ICCVAM is heralded as a tool for streamlining the regulatory acceptance of alternative test methods, individual federal agencies retain discretion and are at liberty to reject recommended alternatives.61

*468 1. ICCVAM Has Approved Two Alternative Tests

Currently, the ICCVAM has approved and recommended two alternative test methods that can be used in place of traditional methods, and they have subsequently been accepted by several regulatory agencies.62 One method is called the Murine Local Lymph Node Assay (LLNA).63 It utilizes a fewer number of mice in lieu of the traditional larger number of guinea pigs, to test chemicals that are likely to cause allergic contact dermatitis64 in workers and consumers. In the traditional test, the bodies of guinea pigs are painted with the chemical to be tested.65 The guinea pigs are also injected with an additional chemical to accelerate the effect of the test chemical in causing dermatitis.66 In the alternative test, however, only the ears of mice are painted with the test chemical and the affects of the chemical are tested via the lymph nodes so that the value of the test is not predicated upon the mice developing the disease.67 Thus, the Local Lymph Node Assay is purportedly less painful,68 less time consuming, and less costly.69

The second alternative test approved by the ICCVAM is Corrositex, an in vitro method.70 This test is used to evaluate the level of dermal corrosivity of acids, bases, and acid derivatives.71 Corrositex can replace the traditional rabbit skin test by determining the corrosivity of a chemical based on how long the chemical takes to break through a skin-like protein barrier and by gauging the color change with a classification chart.72

III. Existing Law

A. Federal Law

The Animal Welfare Act of 197073 responded to public pressure regarding the ways animals are obtained to be used in research laboratories and problems  *469 pertaining to stolen pets and animal dealers.74 The Act insures that “animals intended for use in research facilities ... are provided humane care and treatment.”75 However, the Act fails to define “humane care and treatment.”76 Moreover, although delivering tranquilizers and anesthetics to test animals is required, an exception remains for the researcher to withhold anesthetics if she determines it to be “scientifically necessary.”77 Beyond the anesthetic “requirement,” the Animal Welfare Act does not govern the procedures used during animal research testing.78 This means that, legislation notwithstanding, researchers retain virtual autonomy regarding the procedures used for animal research testing.79 Thus, protection under the Act does not require procedures that prevent pain nor does it prevent unnecessary animal experimentation.80

B. State Law

California's anti-cruelty law states, in pertinent part: “every person who maliciously and intentionally maims, mutilates, tortures, or wounds a living animal, or maliciously and intentionally kills an animal, ... overworks, ... deprives of necessary sustenance, drink, or shelter, ... [or] subjects any animal to needless suffering,”81 is in violation of this law.

The negative and affirmative duties imposed by the anti-cruelty statute seemingly provide solid animal protections.82 However, most laboratory research facilities are exempted from California's anti-cruelty law.83 The use of animals in medical research facilities is regulated,84 but the legislative findings acknowledge that “the public health and welfare depend on the humane use of animals for *470 scientific advancement ....”85 Notably, the State has not defined what “humane” use means.86 Moreover, enforcement can occur only through public prosecution, which typically provides redress only for the most egregious practices.87 Consequently, the failure to adequately define the baseline of animal care, coupled with sporadic public enforcement, often renders animal protection statutes to be symbolically expressive, but ineffectual—“[t]hey say much more than they do.”88 Finally, medical research regulations do not apply to cosmetic businesses that use animals for testing.89 Thus, no authority exists to prohibit arcane tests such as the Draize eye-irritancy test or the LD50.90

IV. Chapter 476

The California State Legislature adopted Chapter 476 to give legal force to the recommendations of the ICCVAM within the cosmetic industry.91 Chapter 476 prohibits manufacturers and testing facilities from using traditional animal test methods for product safety testing when an alternative has been validated and recommended by the ICCVAM and subsequently adopted by the relevant federal oversight agency.92

A federal agency officially adopts an ICCVAM recommendation when it publishes its acceptance in the Federal Register.93 Upon publication, a California manufacturer of a product under the regulation of a federal agency is required to utilize the adopted alternative test method in order to meet the agency's regulatory testing requirements.94

If a business violates Chapter 476, the exclusive remedies for enforcement are injunctive relief and a civil penalty not to exceed five thousand dollars.95 The statute mandates that only the Attorney General, the district attorney, or the city attorney,96 may bring forth a cause of action.97 Only if the government entity prevails may it recover costs, attorney fees and the civil penalty.98

*471 IV. Analysis

Under Chapter 476, animal advocate groups are not empowered to bring civil actions against businesses allegedly in violation of alternative testing mandates.99 Early versions of this legislation granted animal advocate organizations a private right of action to instigate suits on behalf of unlawfully injured animals.100 Such legislation was never enacted, primarily due to its opposition: manufacturers who sell products in California and medical researchers successfully lobbied against the bill from providing any direct legal recourse to animal advocate groups.101 The opposition was predicated upon the belief that animal advocate groups would instigate frivolous litigation by using Chapter 476 as a tool for industry harassment.102

Proper standing is a threshold question for any party instigating a civil action because without standing, the court is not empowered to adjudicate the case.103 The “standing to sue” requirement aims to “ensure that the courts will decide only actual controversies between parties with a sufficient interest in the subject matter of the dispute to press their claim with vigor.”104 Standing in federal courts is governed by the “[c]ases”105 or “[c]ontroversies”106 mandate of Article III of the United States Constitution.107 Federal cases have construed this constitutional limit on federal *472 jurisdiction to require the plaintiff to (1) plead an injury-in-fact, which is both not speculative or conjectural and actual or imminent; (2) the alleged injury must be causally connected to the conduct of the defendant; and (3) it must be likely that the injury may be redressed by a judicial decision.108

Since California's Constitution has no “case” or “controversy” requirement, standing in our State's courts is not governed by the same standard.109 California cases have held that “only parties with a real interest in a dispute have standing to seek its adjudication.”110 A “real party in interest” generally means that the plaintiff has a right to relief in court based upon substantive law.111 This real party in interest requirement aims to protect a defendant from multiple lawsuits and harassment and to determine the liability alleged in the complaint.112 Moreover, unless a statute confers a private right of action, loss or injury incurred is damnum absque injuria—damage without legal redress against the person causing it.113

The rationale in favor of granting animal advocates standing is demonstrated in Animal Welfare Institute v. Kreps.114 In Kreps, the court observed that “[w]here [a statute] is expressly motivated by considerations of humaneness toward animals, who are uniquely incapable of defending their own interests in court, it strikes us as eminently logical to allow groups specifically concerned with animal welfare to invoke the aid of the courts in enforcing the statute.”115 The court held that the animal welfare organization achieved standing both pursuant to a statutory grant of power as well as by satisfying the federal standing prerequisites.116 The satisfaction of standing present in Kreps, however, is generally an anomaly; animal advocate group's efforts to achieve standing has largely failed.117

*473 The real party in interest requirement has stymied advocate groups from attaining judicial relief in our State's courts because it is the animal who is the real party in interest. For example, within the meaning of Chapter 476, a business who unlawfully tests on animals would injure the animal and violate the animal's statutory protection, not the animal advocate group suing on its behalf. Moreover, in enacting Chapter 476, the California State Legislature specifically did not confer a private right of action to any person or group, other than the public enforcement officials; in the absence of statutory private right of action, those groups do not have a legally cognizable right in relation to the would-be injury and are thus not empowered to sue.118

Pursuant to Chapter 476, unlawful injury to animals may be redressed via governmental authorities empowered with statutory enforcement. Yet it is argued by animal advocates that public enforcement agencies place a lower priority in protecting animal welfare due to workload constraints, thus are ineffectual with their statutory obligations.119 Accordingly, although the fear of litigation harassment from animal advocates may be valid, perhaps a better alternative to denying animal advocates statutory standing altogether is the following: the State Legislature could provide a private right of action to nonprofit groups whose aim it is to protect animal welfare, but require that notice of an alleged violation first be provided to the Attorney General and local prosecutor. These officers may then decide whether to pursue an action against a manufacturing company or testing facility allegedly in violation of Chapter 476.120 In this way, groups whose interests are unilaterally focused on animal welfare could compel better enforcement of statutes such as Chapter 476, while simultaneously creating an alternative to imposing yet another enforcement duty on an already overburdened government entity.

V. Conclusion

Chapter 476 codifies the mandatory use of available and approved alternative testing, which is what a number of corporations are moving towards on their own.121 *474 Chapter 476 is largely a watered-down version of what its author had originally intended: civil penalties were substituted for criminal repercussions, the Draize Test is not specifically prohibited,122 and animal rights groups are denied legal standing to bring a private cause of action against business entities in violation of Chapter 476.123 Nevertheless, Chapter 476 is groundbreaking because it remains the first law in California to create a limited ban on animal testing when a federally approved and adopted alternative test exists.124 Moreover, Chapter 476, through the ICCVAM, delivers the force of scientific validation to the cosmetic industry, necessary to generate safer products to an increasingly conscience consumer base.

Footnotes

1 Clifford J. II Shultz & Morris B. Holbrook, Marketing and the Tragedy of the Commons: A Synthesis, Commentary, and Analysis for Action, 18 J. Pub. Pol'y & Mktg 15, available in 1999 WL 21221619.

2 Peter Singer, Animal Liberation: A New Ethics for Our Treatment of Animals 50-51 (1975).

3 Dallas Pratt, Alternatives to Pain in Experiments on Animals, ch. 13, available at http://www.animalwelfare.com/lab_animals/pratt/prat-idx.htm #contents (last visited July 14, 2000).

4 See Shultz & Holbrook, supra note 1, at 2-3 (proposing market strategies to address the “commons problem” and to create solutions for environmental challenges).

The “commons problem,” called “externalities” by economists and “social traps” by behavioral scientists, refers to our paradoxical human tendency to choose personal convenience and immediate reinforcement at the expense of long-term negative repercussions to ourselves, society or the planet. Id. Physical manifestations of this “tragedy of the commons” include extensive pollution, non-sustainable timber-cutting practices, and in general, the over-consumption of natural resources to meet our daily wants and needs. Id.

5 Federal law defines “cosmetic” as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” 21 U.S.C.A. § 321(i) (West 1999).

6 Barbara Thomas, Fashionable SoCal Beauty: The Sign of Alternative Testing, L.A. Times, Jan. 22, 1999, at E3, available in 1999 WL 2122907.

7 Shultz & Holbrook, supra note 1, at 14; see, e.g., Joanne Zurlo et al., Animals and Alternatives in Testing History, Science, and Ethics ch. 3, available at http://caat.jhsph.edu/pubs/animal_alts/animal_alts.htm (last visited Aug. 20, 2000) (copy on file with the McGeorge Law Review) (recounting how Racheal Carson's 1962 book, A Silent Spring, incited evaluation of how human conduct collides with ecosystems, leading many towards greater reverence for the Earth's resources and its human and animal inhabitants).

8 Constance Holden, Much Work but Slow Going on Alternative to Draize Test, Science 185 (1988), available in 1988 WL 2616332.

9 See Facsimile from Alistair Jackson, Director of Values & Vision, The Body Shop USA, to Beverly McGraff, California Representative, Doris Day Animal League (Apr. 21, 2000) (copy on file with the McGeorge Law Review) (noting that The Body Shop, a billion-dollar international skin and hair care products company is known for its “anti-animal cruelty” testing on its products); id. (expressing support for SB 2082, currently enacted as Chapter 476, and The Body Shop's historical non-use of live animal testing). But see Canedy, infra note 49 at C2 (inferring that no product is truly “cruelty-free” because most chemicals have previously been tested on animals, the results of which are stored and subsequently utilized).

10 Strange Bedfellows Join to Support Bi-Partisan Bill to Expedite Acceptance of Alternatives to Animal Tests, US Newswire, May 3, 2000, available in 2000 WL 4144619 [hereinafter Strange Bedfellows] (reporting on the unusual coalition of animal rights groups and cosmetic corporations joined in support of alternative testing legislation); see Senate Judiciary Committee, Committee Analysis of SB 2082, at 2 (Apr. 25, 2000) (noting that Senator O'Connell, the author of Chapter 476, has been attempting to pass similar legislation for the past eleven years); id. (shedding light on the three previously attempted bills sponsored by Senator (then-Assembly Member) O'Connell: AB 2461 (1989) criminalizing certain animal testing procedures, specifically the Draize Test and the Skin Irritancy Test, AB 110 (1991) narrowing the criminal repercussions for use of the Draize Test and the Skin Irritancy Test for cleaning and cosmetic products, and SB 777 (1999), a bill substantively similar to Chapter 476, which died in the Senate Judiciary Committee, despite its ability to overcome opposition up until that point).

11 See infra Part II.C.1 (discussing two alternative tests which have been federally approved and recommended as alternatives to the traditional animal tests).

12 See Cal. Civ. Code § 1834.8 (enacted by Chapter 476) (codifying the mandate of alternative testing once a particular test is approved by the Inter-Agency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) and subsequently adopted by the appropriate federal regulatory agency).

13 See Cal. Civ. Code § 1834.8(e) (enacted by Chapter 476) (stating that the section does not pertain to medical or drug research, or the development of biomedical products and devices); id. § 1834.8(f)(2)-(3) (defining manufacturer and contract testing facility as “any partnership, corporation, association, or other legal relationship that produces chemicals, ingredients, product formulations, or products in this state”).

Throughout its legislative life, the force of opposition to Chapter 476 was from the medical research and scientific communities, who viewed the bill's medical exemption, prior to amendment, as dangerously vague and overbroad. See generally Letter from Coalition Opposed to SB 2082, Livingston & Mattesich to the California Senate Judiciary Committee (Apr. 18, 2000) [hereinafter Coalition Letter] (copy on file with the McGeorge Law Review) (listing seventeen associations or corporations opposed to SB 2082 and explaining their basis for opposition). The medical community feared Chapter 476 could have ramifications on animal testing conducted for medical and drug research and development, if not further defined. Id. Senator O'Connell demonstrated his willingness to work with the medical research community's concerns with the May 3, 2000 amendment. Compare SB 2082 (2000) (as introduced on Feb. 25, 2000, but not enacted) (defining the original medical research exemption as “research related to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of humans and animals”), with Cal. Civ. Code § 1834.8(f)(5) (enacted by Chapter 476) (adding to the aforementioned text “or related to the development of biomedical products, devices, or drugs as defined in Section 321(g)(1) of Title 21 of the United States Code”). See generally Letter from Norman Plotkin, Associate Director of Government Relations, California Medical Association, to Senator Jack O'Connell, author of SB 2082 (May 22, 2000) (copy on file with the McGeorge Law Review) (expressing support of SB 2082, as amended May 3, 2000, relating to the medical research exemption).

14 See Cal. Civ. Code § 1834.8(f)(7) (enacted by Chapter 476) (explaining that the recommended alternative test method may mean one that merely reduces the traditional use of animals); infra Part II.C.1 (noting that the use of the Local Lymph Node Assay, an ICCVAM recommended alternative test, uses fewer animals than the traditional test method).

15 See infra Part II.C (discussing the purpose and authority of the ICCVAM).

16 Cal. Civ. Code § 1834.8(d) (enacted by Chapter 476). See infra Part IV (explaining the requirement for legal standing to bring an action against a business allegedly in violation of Chapter 476 and discussing the civil penalties possible under Chapter 476).

17 Zurlo, supra note 7, ch. 1.

18 Id. at ch. 3.

19 Id.

20 Id.

21 Id.

22 Id.

23 Id.

24 Id. at ch. 3-4.

25 Holden, supra note 8, at 185.

26 Singer, supra note 2, at 50-51.

27 See, e.g., Vasanth R. Shenai, If Animal Rights Activists Could Write Federal Research Policy, 4 Animal L. 211, 212 (1998) (listing the Draize eye irritancy test as one example of blatant disregard for animal welfare and rights); Senate Judiciary Committee, Committee Analysis of SB 2082, at 5 (Apr. 25, 2000) (noting that two previously vetoed bills sponsored by Senator O'Connell banned the use of the Draize Test and the Skin Irritancy Test). Upon vetoing the bills, then-Governor Wilson explained that criminalization of use of certain tests was premature because there was no scientific consensus of consumer safety regarding use of alternative test methods for all products. Id. In response, AB 110 narrowed the products to cosmetics and cleaning products that would require alternative testing, but Governor Wilson again vetoed the measure, stating that “alternatives can not ... completely replace the use of animals for testing[.]” Id.

28 Zurlo, supra note 7, at ch. 4. See Animal Research Takes Lives, available at http://www.health.org.nz/draize.html (last visited July 14, 2000) [[hereinafter Animal Research] (stating that the real reason for continued use of the Draize test is because it is primarily conducted by contract facilities, whose business it is to conduct tests on animals; the same is not necessarily true for the product manufacturers). Testing on animals is a highly lucrative industry and some physicians opine that testing on animals is an inadequate measure for addressing human therapy after exposure to a toxic product. Id.

29 Zurlo, supra note 7, at ch. 4.

30 See infra Part II.C (defining in vivo testing and in vitro testing).

31 Zurlo, supra note 7, at ch. 4.

32 See Animal Research, supra note 28 (positing that the animal testing contract industry is a powerful and lucrative strong-arm against government restraints).

33 Marjorie Sun, Lots of Talk About LD50, 222 Science 1106, 1106, (1983) available in 1983 WL 2003647.

34 Id.

35 Id.

36 Id.

37 Id.

38 Id.

39 See infra note 40, at 725-26 (implying that the term “animal rights” should not be used as a catch-all because it has an exclusive meaning).

40 See Brenda L. Thomas, Antinomy: The Use, Rights, and Regulation of Laboratory Animals, 13 Pepp. L. Rev. 723, 724 n.7 (1986) (crediting Peter Singer's 1975 Animal Liberation as the genesis of the modern animal rights movement).

41 Singer, supra note 2, at 3.

Peter Singer posits that “speciesism,” a psychological bias that leads members of one group to believe in the superiority of their interests over the interests of another group, is the root of not only racism and sexism, but by analogy, the exploitation of animals, as well. Id. at 7. The following passage, by Sojourner Truth, made at a feminist convention, exemplifies the idea that speciesism has translated, historically, across racial and gender lines, and may also refute the common justification that humans are superior over animals:

they talk about this thing in the head; what do they call it? [“Intellect,” whispered someone near by.] That's it. What's that got to do with women's rights or Negroes' rights? If my cup won't hold but a pint and yours holds a quart, wouldn't you be mean not to let me have my little half-measure full?

Id. Cf., Thomas, supra note 40, at 728 (explaining that historically, and current through today, most of society believes that the relevance of animals is only the extent to which they benefit people and that “[a]nimals are dealt ‘rights' only when humans have playing cards to spare.” (quoting Note, Toward Legal Rights for Laboratory Animals? 10 J. Legis. 198, 211 (1983)). But see Joel Feinberg, Can Animals Have Rights?, Animal Rights and Human Obligations 190, 194-95 (Tom Regan & Peter Singer eds., 1976) (noting that an argument against animals having rights is that animals do not possess interests of their own; thus, it is illogical to accord them rights).

42 Singer, supra note 2, at 3.

43 Id. at 6.

44 See Thomas, supra note 40, at 725-26 (explaining that animal advocates can be categorized into three general groups: (1) animal rights groups, whose main purpose is to utilize educational, legislative, and protest campaigns to effect changes in the law and in society's consideration of animals, (2) animal liberationists, who advocate violence, destruction, and stealing of laboratory animals, and (3) animal welfare groups, who have general concern for the treatment of animals but lend only collateral support for influencing change). But see Lorenz Otto Lutherer & Margaret Sheffield Simon, Targeted: The Anatomy of an Animal Rights Attack 10 (1992) (asserting that since a fundamental animal rights premise is that humans never have the right to use animals for any purpose, the true aim of the animal rights movement goes far beyond restricting the use of animals in research).

45 See Thomas, supra note 40, at 740-42 (providing a historical synopsis of the use of laboratory animals and the advent of animal rights groups). Cf. Lutherer & Simon, supra note 44 (asserting that the phenomenal growth of the animal rights movement is largely due to its tenets of propaganda, and chronicling a couple of break-ins in which animal rights groups vandalized university research centers).

46 Zurlo, supra note 7, at ch. 3.

47 Random House Unabridged Dictionary 1004 (2d. ed. 1993). Test methods that use live animals are called “in vivo.” Id.

48 Zurlo, supra note 7, at ch. 4; see id. (providing a historical review of in vitro toxicology testing).

49 See, e.g., Constance Holden, Cosmetics Firms Drop Draize Test, 245 Science 125 (1989), available in 1989 WL 3077569 (reporting that Avon, Revlon, and Noxell are moving towards the elimination of traditional animal test methods); Dana Canedy, P&G Pledges Cutback in Testing on Animals - Longtime Critics Offer Only Guarded Praise, San Diego Union-Trib., July 1, 1999, at C2 (announcing Procter & Gamble's pledge to end animal use in 80% of its testing for consumer products such as shampoo, cosmetics, skin care, and household cleaners, but tempering the announcement by noting that most chemicals do not need animal testing because they have already undergone extensive testing, thus opining that P&G's announcement was long overdue); Senate Judiciary Committee, Committee Analysis of SB 2082, at 5-6 (Apr. 25, 2000) (noting that Procter & Gamble was a leading proponent of passage of Chapter 476 and that representatives from P&G are on the ICCVAM committee).

50 See Strange Bedfellows, supra note 10 (noting the unusual coalition of animal rights groups and cosmetic industry corporations).

51 National Institutes of Health Revitalization Act of 1993, Pub. L. No. 103-3, § 130(a), 107 Stat. 122, 169 (1993).

52 National Toxicology Program; Meeting of the Advisory Committee on Alternative Toxicological Methods, 64 FR 50,297, 50, 297 (1999) [hereinafter National Toxicology Program].

53 The Ad Hoc Interagency Coordinating Committee on the Validation of Alternative Methods, Validation and Regulatory Acceptance of Toxicological Test Methods, NIH Pub. No. 97-3981 (1997).

54 Letter from William S. Stokes, Co-Chair, ICCVAM, to Senator Jack O'Connell, California State Senate [hereinafter Stokes-O'Connel Letter] (Apr. 20, 2000) (copy on file with the McGeorge Law Review).

55 National Toxicology Program, supra note 52, at 50,297.

56 Senate Judiciary Committee, Committee Analysis of SB 2082, at 3 (Apr. 25, 2000).

57 Stokes-O'Connell Letter, supra note 54, at 2.

58 Id.

59 See Cal. Civ. Code § 1834.8(f)(9) (enacted by Chapter 476) (stating that a federal agency officially adopts an alternative test when it publishes its acceptance in the Federal Register).

60 Stokes-O'Connell Letter, supra note 54, at 3.

61 Id.

62 Id. at 2.

63 Id.

64 See National Institutes of Health Press Release, Dec. 28, 1999 [[hereinafter NIH Press Release] (copy on file with the McGeorge Law Review) (reporting that contact dermatitis is a skin irritation caused by many household products and cosmetics, and is also the second most common occupational disease).

65 Id.

66 Id.

67 Id.

68 Id.

69 Id.

70 Stokes-O'Connell letter, supra note 54, at 2.

71 Letter from William S. Stokes, ICCVAM Co-Chair, Department of Health & Human Services, to W. Richard Ulmer, President, In Vitro International, Inc., (June 18, 1999) [hereinafter Stokes-Ulmer Letter] (copy on file with the McGeorge Law Review).

72 Wade Roush, Hunting for Animal Alternatives, 274 Science 168 (1996) available in 1996 WL 12003935.

73 7 U.S.C.A. § 2131 (West 1999).

74 Thomas, supra note 40, at 742-43.

75 7 U.S.C.A. § 2131(1) (West 1999).

76 See id. § 2132 (West 1999) (defining “person,” “Secretary,” “State,” “dealer,” “animal,” but not “humane care and treatment”).

77 Id. § 2143(a)(3)(A)-(C)(v) (West 1999).

78 See id. § 2143(a)(6)(A)(ii) (West 1999) (specifying that the Act should not be construed as placing regulatory restrictions on the “performance of actual research or experimentation by a research facility as determined by such research facility”); Shenai, supra note 27, at 215-18 (noting various oversights of the Act that render the protection of research animals ineffective).

79 Thomas, supra note 40, at 743.

80 Id.

81 Cal. Penal Code § 597(a)-(b) (West 1999). Violating this law produces an offense punishable as a felony, misdemeanor, or a fine not to exceed $20,000 or as a felony or misdemeanor and a fine not to exceed $20,000. Id.

82 Cass R. Sunstein, Standing for Animals (With Notes on Animal Rights), 47 UCLA L. Rev. 1333, 1337 (2000).

83 See Cal. Penal Code § 599c (West 1999) (exempting, among other categories, “properly conducted scientific experiments or investigations performed under the authority of the faculty of a regularly incorporated medical college or university of this state.”) Anti-cruelty statutes also do not protect farm animals from cruelty, or animals that are produced and used for food, so in these arenas, abusive practices are largely unregulated at the state level. Sunstein, supra note 82, at 1339.

84 Cal. Health & Safety Code §§ 1650-1677 (West 1990).

85 Id. § 1650.

86 See id. § 1651 (West 1990) (defining “person,” and “board,” and “department,” but not “humane”).

87 Sunstein, supra note 82, at 1339.

88 Id.

89 Cal. Health Safety Code § 1669 (West 1990).

90 See Thomas, supra note 40, at 747 (criticizing state statutes as insufficiently defining the word “animal” and for failing to aptly provide meaning to “cruelty”).

91 See Cal. Civ. Code § 1834.8(e) (enacted by Chapter 476) (explaining that the section does not apply to medical or drug research and includes a specific exemption).

92 Stokes-O'Connell Letter, supra note 54, at 3.

93 Cal. Civ. Code § 1834.8(f)(9) (enacted by Chapter 476).

94 Id. § 1834.8(a) (enacted by Chapter 476).

95 Id. § 1834.8(d) (enacted by Chapter 476).

96 See id. (limiting the government entity's legal standing to that of the county or city in which the violation allegedly occurred).

97 Id.

98 Id.

99 Id.; see Thomas, supra note 40, at 737-40 (discussing the obstacles and implications of legal standing for animals and animal rights organizations).

100 See SB 2082, Feb. 25, 2000 (as introduced but not enacted) (providing that a civil action may be brought by “any entity lawfully organized under the federal Internal Revenue Service Code as a 501(c) or 501(c)4 organization for the purpose of protecting or providing for the welfare of animals”).

101 See, e.g., Letter from Linda C. Cork, Professor and Chair, American College of Veterinary Pathologists, to Senator Jack O'Connell, California State Senate, Mar. 14, 2000 (copy on file with the McGeorge Law Review) (stating that her objections to SB 2082 were in part due to the standing provided to animal rights groups and predicting frivolous litigation). Linda Cork's objections were made prior to changes regarding the medical research exemption, as well as prior to the deletion of legal standing for animal rights' organizations. Id.; see Coalition Letter, supra note 13, at 2 (asserting that animal rights groups have continually been denied standing by federal courts and maintaining that animal rights groups should not be granted legal standing because of their radical tactics against testing laboratories). Members in the Coalition opposed to SB 2082 granting animal advocates standing included Bayer Corporation, Bristol-Myers Squibb, The Cosmetic, Toiletry & Fragrance Association, Johnson & Johnson, The Soap and Detergent Association, and Warner-Lambert Company, among others. Id. at 3.

102 See Coalition Letter, supra note 13, at 2-3 (explaining that animal rights groups have declared war against manufacturing and testing laboratories and inferring that documented radical and violent responses from animal rights groups would likewise transfer into highly attenuated lawsuit claims against testing laboratories).

103 See Killian v. Millard, 228 Cal. App. 3d 1601, 1604-06, 279 Cal. Rptr. 877, 878-80 (1991) (writing that a defendant in the suit did not have a substantive right in the contract to argue its validity, and consequently holding that the court below had no power to hear that complaint; further holding that standing issues are not waived for failure to raise at trial).

104 Common Cause of Cal. v. Board of Supervisors, 49 Cal. 3d 432, 439, 777 P.2d 610, 613, 261 Cal. Rptr. 574, 577 (1989).

105 U.S. Const. art. III, § 2, cl. 1.

106 Id.

107 See Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (holding that wildlife groups did not sufficiently establish standing in their challenge to a federal regulation promulgated pursuant to the Endangered Species Act ; the group did not prove an imminent injury, and their claim that the regulation prevented them from studying and observing endangered animals was not redressable by a favorable decision).

108 Id. at 560-61.

109 National Paint & Coatings Ass'n. v. California, 58 Cal. App. 4th 753, 761, 68 Cal. Rptr. 2d 360, 365 (1997).

110 Killian, at 1605, 279 Cal. Rptr. at 879. See Cal. Civ. Proc. Code § 367 (West Supp. 2001) (qualifying that the rule is subject to contrary statutory authorization).

111 Killian, at 1605, 279 Cal. Rptr. at 879.

112 Bank of the Orient v. Superior Ct., 67 Cal. App. 3d 588, 594, 136 Cal. Rptr. 741, 744 (1977).

113 Vikco Ins. Services, Inc. v. Ohio Indemnity Co., 70 Cal. App. 4th 55, 62, 82 Cal. Rptr. 2d 442, 447 (1999); Pacific Bell v. City of San Diego, 81 Cal. App. 4th 596, 604, 96 Cal. Rptr. 2d 897, 905 (2000).

114 561 F.2d 1002 (D.C. Cir. 1977) (quoted approvingly in Farm Sanctuary, Inc. v. Department of Food and Agric., 63 Cal. App. 4th 495, 503, 74 Cal. Rptr. 2d 75, 79 (1998)). Cf., Animal Legal Defense Fund, Inc. v. Glickman 154 F.3d 426, 438 (D.C. Cir. 1998) (holding that the federal jurisdiction standing requirement was satisfied where the plaintiff based the “injury to [his] aesthetic interest in observing animals living under human conditions” while visiting animals at the zoo, and not based on his association with an animal relief and rescue organization). See Sunstein, supra note 82, at 1342-58 (analyzing the complexities of federal standing for citizens protecting the interests of animals and concluding that citizens are entitled to sue, by invoking their own injuries as a predicate, when confronted with the deprivation of legally required information, competitive disadvantage, or aesthetic injury); see generally Christopher D. Stone, Should Trees Have Standing? Toward Legal Rights for Natural Objects, 45 S. Cal. L. Rev. 450 (1972) (arguing for a paradigm shift that would grant legal status to natural objects).

115 Kreps, 561 F.2d at 1007.

116 Id. at 1006-10.

117 Thomas, supra note 40, at 738.

118 See generally White v. Davis, 13 Cal. 3d 757, 762-63, 120 Cal. Rptr. 94, 97-98, 533 P.2d 222, 225-26 (1975) (holding that a tax payer could sue on behalf of the public interest pursuant to statutory authorization to challenge illegal spending of public funds); Farm Sanctuary, 63 Cal. App. 4th at 501, 74 Cal. Rptr. 2d at 77 (noting that the plaintiff was an “interested party” within the meaning of the statutory grant of standing for declaratory relief pertaining to the validity of regulations promulgated pursuant to the Humane Slaughter Law); National Paint & Coatings Ass'n., at 761-62, 68 Cal. Rptr. 2d at 365 (holding that the statutory grant for “any person” to sue in the public interest did not contravene state or federal due process guarantees).

119 See generally, Sustein, supra note 82, at 1336-42 (discussing the shortcomings and philosophical obstacles of not providing legal standing to animals); Thomas, supra note 40, at 737-39 (same).

120 See National Paint & Coatings Ass'n., 58 Cal. App. 4th at 757, 68 Cal. Rptr. 2d at 362 (providing the substantive provisions of the Safe Drinking Water and Toxic Enforcement Act of 1986, passed by ballot initiative Proposition 65).

121 See supra note 49 (noting that a number of corporations were eliminating the use of animal tests in 1989).

122 Supra note 10; supra note 27.

123 See supra Part IV (discussing that legal standing for animal advocate groups was originally provided for by the author of Chapter 476, but ultimately omitted).

124 Senate Judiciary Committee, Committee Analysis of SB 2082, at 3-4 (Apr. 25, 2000).