# Amicus Curiae Brief — International Union, United Automobile, Aerospace & Agricultural Implement v. Johnson Controls, Inc. > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385012_0705%3A19 ## Record - **Collection:** Supreme Court brief - **Document type:** Amicus Curiae Brief - **Published:** January 1, 1991 - **Citation:** 499 U.S. 187 ## Text Supreme Court, US | \ : Whe FILED sy, i} 1590 No. 89-1215 { wei ‘ Beit FINA) jr CTERA IN THE . Supreme Court of the United States OCTOBER TERM, 1989 INTERNATIONAL UNION, UNITED AUTOMOBILE, AEROSPACE AND AGRICULTURAL IMPLEMENT WORKERS OF AMERICA, ef a/., Petitioners, Ve JOHNSON CONTROLS, INC., Respondent. On Writ of Certiorari to the United States Court of Appeals for the Seventh Circuit BRIEF OF NATURAL RESOURCES DEFENSE COUNCIL, INC. AS AMICUS CURIAE IN SUPPORT OF PETITIONERS THOMAS O. MCGARITY Counsel of Record University of Texas School of Law 727 E. 26th Street Austin, Texas 78705 (512) 471-5151 ALBERT H. MEYERHOFF 90 New Montgomery San Francisco, CA 94105 Attorneys for Amicus Curiae A TT SL DESEO SSL ICES TENET - 5 EY. A TEES S20, BT TILER RIE I ELI OL GTS WILSON - EPES PRINTING Co., INC. - 789-0096 - WASHINGTON, D.C. 20001 ® ot » 60 TABLE OF CONTENTS Page rs Cr ee scnonheumnbnahiueseseneess 1 be 8 PY 4 ale ae 8 6 5) | 4. y er 2 ARGUMENT: THE COURT OF APPEALS ERRED IN CON- CLUDING THAT SCIENTIFIC DATA FROM EXPERIMENTS WITH LABORATORY ANI- MALS ARE TOO SPECULATIVE TO SUPPORT CONCLUSIONS ABOUT THE REPRODUCTIVE TOXICITY OF CHEMICALS IN HUMAN INIT -Uccandpbarentascanpinndtaccumicackcareiiartaestelenactnseses eleemeebiin 3 A. An Established Body of Scienti*c Opinion Sup- ports the Use of Laboratory Animal Studies in Assessing the Reproductive Toxicity of Chem- ee es ee a eeeeeugunesonbenshens dD B. Courts and Administrative Agencies Have Con- sistently Relied Upon Laboratory Anima! Strd- ies in Assessing the Risks of Chemicals to Hu- rete easegcteunmesinsenounsoniomn SE 12 CERN AIIIU OD vcecctsassecesssersecncese CA ee OLE IS,2- e 20 il TABLE OF AUTHORITIES CASES: Page B. 1! v. Goddard, 366 F.2d 177 (7th Cir. 1966) ...... 16 Environmental De fense Fund, Ine. v. Costle, 578 F.2d 3387 (D.C. Cie. 1970) 00 15 Environmental Defense Fund, Inc. v. EPA, 510 F.2d 1292 (D.C. Cie. 1076) cee 15 Environmental Defense Fund, Inc. v. EPA, 548 F.2d 996 (D.C. Civ. BOGG) ..ccscocnceeee 15 Environmental Defense Fund, Inc. v. EPA, 598 F.2d 62 (D.C. Cit. BOGB) ..cccscee 15 Environmental Defense Fund, Ine. v. Ruckelshaus, 439 F.2d 684 (D.C. Cis. 1971) We 15 Herevles, Inc. v. EPA, 598 F.2d 91 (D.C. Cir. Industrial Union De pt. AFL-CIO v. American Petroleum Inst., 448 U.S. 607 (1980) .........0000. 14 International Union v. Johnson Controls, Inc., 886 F.2d 871 (7th Cir. 1968) 0 4, 7,16 Society of Plastics Industry v. OSHA, 509 F.2d 1301 (D.C. Civ, 1GGG) ..2c.ceccccccsceuceuene 15 Synthetic Organie Chem. Mfrs. Assn. v. Brennan, 003 F.2d 1155 (3rd Cir. 1974) ....22.20000 15 STATUTES AND REGULATIONS: 16 C.F.R. § 1500.17 (a) (10) (1989) 12 29 C.F.R. § 1900.111 (a) (1980) ee 14 29 C.F.R. § 1990.1438(g¢) (1969) ................................ 14 40 C.F.R. § 61, Subpart F (1989) nana 13 40 C.F.R. § 154.7(a) (2) (i) (1989) 12 40 C.F.R. § 261.11(a) (1968) 14 40 C.F.R. § 786 (1968) ........... eee 13 45 C.F.R. § 46 (1969) ...............0.. eee 5 $8 Fed. Reg. 108029 (1978) ........- 2... 14 39 Fed. Reg. 35890 (1974) 2.2000. -apsiaeetenaaa 14 40 Fed. Reg. 6 69532 Ri: | RAP 13 41 Fed. Reg. 30476-77 (1976) a 13 42 Fed. Reg. 6532 (1977) ............... 13 43 Fed. Reg. 11514 (1978) 0... ieee 16 43 Fed. Reg. 12308-12310 (1978) .... 12 43 Fed. Reg. 52952 (1978) 17 ili TABLE OF AUTHORITIES—Continued i oo. cnsnevcsseuscnccserenscsesssccees EE ND oo. cereccsesesnsnecsenseceseoreess- wu i ee ccc cnesccessancseeecaccessesoses 53 Fed. Reg. 24834 (1984) ................................ 53 Fed. Reg. 24850 (1988) 0.0 2. 54 Fed. Reg. 9386 (1989)... 7 7 U.S.C. § 136-1387y (1988) 15 U.S.C. $§ 1261, 1262 (1988) 15 U.S.C. § 2079 (a) (1988) 15 U.S.C. $$ 2601-2629 (1988) 21 U.S.C. § 348(c) (3) (A) (1988) 29 U.S.C. § 655 (1988) 33 U.S.C. < 1317(a) (1958) 42 U.S.C. g 300(f) ef seg. (1982) 42 U.S.C. R 6421 (1982) 42 U.S.C. § 6901 ef seq. (1982) 42 U.S.C. § 7412 (1982) OTHER AUTHORITIES: Equal Employment Opportunity Commission, Policy Guidance on lU'nited Auto Workers v. Johnson Controls, Inc. Neen TTT ree cesuecucscesrereee National Academy of Sciences-National Research Council, Biologic Markers in Reproductive Toxi- Ce cueenucccssceces National Academy of Sciences-National Research Council, Risk Assessment in the Federal Gov- ernment: Managing the Process (1983) National Academy of Sciences-National Research Council, Principles for Evaluating Chemicals in the Environment (1975) - National Academy of Sciences-National Research Council, Evaluating the Safety of Food Chem- icals (1970) | I. Nisbet & N. Karch, Chemical Hazards to Hu- man Reproduction (1983) Note, E.vrelusionary Employment Practices in Haz- ardous Industries: Protections or Discrimina- tions? 5 Colum. J. Envy. L. 97 (1978) 10 IN THE Siuprenw Court of the Wniied States OCTOLER TERM, 1989 No. 89-1215 INTERNATIONAL UNION, UNITED AUTOMOBILE, AEROSPACE AND AGRICULTURAL IMPLEMENT WORKERS OF AMERICA, ef a/., Petitions rs, . JOHNSON CONTROLS, INC., Respondent. On Writ of Certiorari to the United States Court of Appeals for the Seventh Circuit BRIEF OF NATURAL RESOURCES DEFENSE COUNCIL, INC. AS AMICUS CURIAE IN SUPPORT OF PETITIONERS INTERESTS OF AMICUS! The Natural Resources Defense Council (NRDC)}, a nonprofit corporation whose principal place of business is at 122 East 42nd Street, New York, N.Y., has offices in Washington, D.C. and San Francisco, California, and a 1 All parties have consented to the submission of this) brief, Written jetters of consent will be on file with the Clerk. 2 membership of more than 125,000 persons across the United States and in several other nations. NRDC is dedicated to the perservation, enhancement and defense of the human environment and natural resources of the United States. In carrying out these objectives, NRDC has undertaken efforts to obtain clean air, clean water and toxic substances control, including activities to en- sure effective implementation of health and _ environ- mental protection statutes. In connection with these ac- tivities, NRDC has on numerous occasions relied upon and supported governmental reliance upon laboratory animal studies to assess the risks that exposure to chem- icals poses to humans. SUMMARY OF ARGUMENT The Court of Appeals erred in concluding that scientific data from experiments with laboratory animals are too speculative to support conclusions about the reproductive toxicity of chemicals in human males. Scientists rou- tinely use laboratory animal testing to assess the risks that chemicals may pose to human beings. The regula- tory agencies that Congress has charged with protecting humans from the harmful effects of chemicals in the en- vironment have consistently adhered to the principle that laboratory animal studies are predictive of human health risks, absent clear proof to the contrary. The Court of Appeals was therefore wrong as a matter of scientific fact, as a matter of law, and as a matter of sound pub- lie policy in concluding that laboratory animal evidence of the reproductive toxicity of lead in human males was “speculative and unconvincing.” 3 ARGUMENT THE COURT OF APPEALS ERRED IN CONCLUDING THAT SCIENTIFIC DATA FROM EXPERIMENTS WITH LABORATORY ANIMALS ARE TOO SPECULA- TIVE TO SUPPORT CONCLUSIONS ABOUT THE RE- PRODUCTIVE TOXICITY OF CHEMICALS IN HU- MAN MALES. In upholding Respondent Johnson Controls’ “business necessity’’ defense, both the District Court and the Court of Appeals rejected Petitioner International Union’s ar- gument that the risks to unborn children posed by worker exposure to lead in the workplace is not limited to fe- males.” The International Union offered expert testi- mony to establish that male worker exposure to lead in the workplace also poses a substantial risk to unborn children. Although the International Union’s experts did not attempt to prove conclusively that any particular human malformity had resulted from any particular father’s exposure to lead in the workplace, they concluded inter alia on the basis of scientific studies conducted with laboratory animals that the exposure of human males to lead in the workplace posed a risk of genetic damage to their offspring. The Court of Appeals found, apparently as a matter of law, that this expert testimony would be inadequate, even if fully accepted by the factfinder, to support a conclusion that male worker exposure to lead * The Court of Appeals addressed ¢! stion of the isefulness of animal studies in evaluating reproduectivg risxs in the context o! the “business necessity” defense, whieh that t found applicable, despite the fact that the defendant's em) ment practices clearly constituted disparate treatment. If this Court accepts Petitioners argument (and the position of Judge Easterbrook below) that in this case of disparate treatment the employer has the burden of proving that the employment practice constitutes a bona fide oceu- pational qualification, then the court need not reach the question of the appropriateness of animal studies for assessing human risks, 4 posed substantial risks to unborn children. In relevant part, the Court of Appeals reasoned as follows: ... |T}he UAW witnesses posited that animal stud- ies had demonstrated that there was a possible risk of genetic damage to human offspring as a result of male lead exposure. The UAW witnesses attempt to bridge the wide chasm between the results of animal studies and a conclusion of genetic harm allegedly transmitted through the male human being with human studies merely establishing a correlation be- tween male lead exposure and changes in sperm shape. It is interesting to note that the UAW has not presented any medical evidence in the record of any human study scientifically documenting genetic defects in human beings resulting from male lead exposure. It is this lack of convincing scientific data that the plaintiffs attempt to gloss over and cast aside in ignoring the differences between the effect of lead on the human and animal reproductive systems. . . . Unlike the record evidence of a substantial risk of harm resulting to an unborn child from ex- posure to lead through the mother’s blood stream and placenta, the evidence of risk to the unborn child resulting from exposure of the father to the lead levels currently present in Johnson Controls’ battery manufacturing factories is, at best, specu- lative and unconvincing. The UAW’s animal re- search evidence does not present the type of solid scientine data necessary for a reasonable factfinder to reach a nonspeculative conclusion that a father’s exposure to lead presents the same danger to the un- born child as that resulting from a female employee's exposure to lead. . . International Union v. Johnson Controls, Ine., 886 F.2d 871, 889-90 (7th Cir. 1989). This statement is erroneous as a matter of law, as a matter of sound publie policy, and as a niatter of scientific analysis. 5 A. An Established Body of Scientific Opinion Supports the Use of Laboratory Animal Studies in Assessing the Reproductive Toxicity of Chemicals. Scientists attempting to assess the toxicity of chemicals to human beings have a limited number of testing op- tions. They can, of course, expose a group of human beings to various predetermined doses of the chemical being tested, observe the effects of the chemical on the exposed humans and their offspring, and compare the re- sponses of the exposed humans to humans in a “control” group of unexposed, but otherwise equivalent humans. Obviously, when a chemical is suspected of producing toxic effects in humans or their offspring, this kind of con‘rolled human testing raises grave moral questions. Past experiences with abuses of human experimentation have led federal agencies to restrict severely the condi- tions under which federally sponsored human experi- ments may take place in this country.‘ -ven if human testing were ethically allowable, it would take several exposed groups containing thousands of individual hu- mans to draw conclusions about the effects of low ex- posures ‘of the sort ordinarily encountered in the work- place! with any degree of statistical confidence. Obvi- ously, such studies would be exceedingly burdensome and expensive. In the absence of controlled human experiments, the next best source of scientific data on the human toxicity of chemicals is an epidemiological study in which a group of humans who have historically been exposed to greater than normal amounts of the chemical is isolated and com- pared to an equivalent “control” group. A whole host of methodological problems typically plague epidemiological studies of workplace chemicals. For example, it is often very difficult to determine the historical exposure levels of the workers in the exposed group. Poor medical rec- ‘See 45 CFR. pt. 16 61989) (Department of Health and Human Services Regulations on the Protection of Human Subjects. 6 ords also make it difficult to ascertain the incidence of particular diseases and to determine the cause of par- ticular deaths. Selection and information biases can con- found attempts to analyze the data objectively. Finally, because most epidemiological studies ean examine only a limited number of subjects, only very strong effects can be confidently isolated.* Because of the serious limitations that plague human testing and human epidemiological studies, scientists test chemicals in laboratory animals to discover their toxic effects. Although scientists generally agree that labora- tory rodents are not identical in all regards to human beings, there is also general agreement that the results of laboratory »nimal toxicity testing are relevant to as- sessing the risks of human exposures to the tested sub- stances. According to the widely-quoted Report of the National Academy of Sciences’ Committee on the Institu- tional Means for Assessment of Risks to Public Health: “The inference that results from animal experiments are applicable to humans is fundamental to toxicological re- search; this premise underlies much experimental biology and medicine. . . .”"° The Carcinogen Guidelines of the *See United States Environmental Pretection Arency, Proposed Guidelines for Assessing Male Reproductive Risk and Request for Comments, 53 Fed. Reg. 24850, 24861 (198%): United States En- vironmental Protection Agency, Proposed Amendments to the Guidelines for the Health Assessment of Suspect Developmental Toxicants; Request for Comments; Notice, 54 Fed. Reg. 9386, I2RGH-99 (1989). See generally National Academy of Sciences- National Research Council, Principles for Evaluating Chemicals in the Environment 126 (1975): National Academy of Sciences- National Research Counci!, Evaluating the Safety of Food Chemi- cals 44 (1970,; Office of Science and Technology Policy, Chemical Carcinogens: A Review of the Science and its Associated Prin- ciples, 50 Fed. Reg. 10572. 10379-80 (1985). * National Academy of Sciences-National Research Council, Risk Assessment in the Federal Government: Managing the Process 22 (1983). 7 Federal Office of Science and Technology Policy, which reflect the combined efforts of senior scientists from all of the major federal regulatory and research agencies, start with the proposition that it is reasonable to treat an animal carcinogen as if it were a human carcinogen. ... This principle has been accepted by all health and regulatory agencies, and is widely regarded by scientists in industry and academia as a justifiable and necessary inference.” These strong statements by panels of experts drawn from the most prestigious members of the scientific com- munity contradict the sugestion in the affidavits of John- son Controls’ paid experts (untested by cross-eXamination or peer review) that the results of animal studies “were not scientifically established as being applicable to hu- mans.” International Union v. Johnson Controls, Ine., 886 F.2d 871, 889 (7th Cir. 1989). The Court of Ap- peals erred in relying on the affidavits of the experts hired by Johnson Controls for the proposition that the International Union’s “animal research evidence does not present the type of solid scientific data necessary for a reasonable factfinder to reach a nonspecuiative conclu- sion....” Jd. at 889. In particular, animal studies are relevant (indeed, often critical) to the assessment of the reproductive risks that chemicals in the workplace environment pose to hu- man beings. Nisbet and Karch, for example, devote a chapter of their took “Chemical Hazards to Reproduc- tion” to “Concordance Between Reported Effects in Humans and Measured Effects in Animais.”” The authors report that ‘“‘{a] basic assumption in toxicology is that effects obser "ed in experimental animals can be used to infer their likely effects (or lack of effects) in humans, with appropriate consideration of the biological! differ- " Office of Science and Technology Policy, Chemical Carcinogens: A Review of the Science and its Associated Principles, 50 Fed. Reg. 10372 (1985). 8 ences between species.” * After examining the human and animal data for a selected group of chemicals su- spected of causing reproductive effects, the authors con- clude: Teratogenic effects in humans are matched by terato- genic effects in one or more species of experimental animal, and are also matched by the effects of sim- ilar risks in at least one species. ... |T]here may be a fairly close concordance in the dose levels at which humans and animals respond to those agents, humans appearing somewhat more susceptible than the most sensitive animal species tested. In addi- tion, .. . there may be similar concordance between humans and animals for other types of effects on reproduction, although in at least one case an ani- mal species appeared to be much more sensitive than humans.* A National Academy of Sciences expert panel began its discussion of the use of biologic markers in reproductive toxicology with the observation that ‘“|e|xtrapolations to humans are to be based on the most sensitive animal species tested, barring clear evidence that the species is toxicologically distinct from humans.” ” The Court of Appeals may also have misunderstood the reason that animal studies typically use one or more dose levels that are considerably higher than the level to which humans are exposed in the workplace. Testing animals at high doses is simply a matter of practical necessity. To detect effects that are significant in large exposed populations requires either testing at higher dose levels or testing an impractical number of animals. One National Academy of Sciences panel explained: ‘I. Nisbet & N. Karch, Chemical Hazards to Human Reproduc- tion 93 (1983). “Jd. at 111. * National Academy of Sciences-National Research Council, Pio- logic Markers in Reproductive Toxicology 3 (1989). 9 The study of reproduction and development poses major resource and logistic problems for those work- ing with laboratory animals. For instance, manage- able sample populations do not reveal increases in toxic events of less than 5 to 10%. For some health effects associated with reproduction and neurode- velopment, such as mutagenesis and teratogenesis, incidences in a human population of 3 per 10,000 are significant. Obviously, these effects cannot be well defined in whole-body ctudies of thousands of ex- perimental animals at a time. Classic toxicology studies of rodents involve the exposure and _ path- ological analyses of 200 animals for 2 years. In such assays, each animal is a surrogate for 1,000,000 people. Birth defects undetectable in this rodent population could be epidemic within ten generations, if they occurred in humans." In this connection, it is important to note that Dr. Silber- geld (one of the plaintiffs’ experts) testified emphatically in her deposition that “|t|here are no clear thresholds for any of these effects of lead.” Silbergeld Deposition at 17. This testimony, which must be taken as true for purposes of a motion for summary judgment, indicates that high dose animal studies are relevant for assessing low dose human risks. It is therefore prudent to assume that, in the absence of a demonstrated threshold if toad causes adverse reproductive effects in laboratory animals at high doses, it will pose some risk of adverse effects in humans even at substantially lower exposure levels. The Court of Appeals apparently failed to recognize that workplace chemicals such as lead can affect fetal development and the health of the subsequently born child in several ways."’ After a fetus is in existence, 1” National Academy of Science-National Research Council, Bio- logic Markers in Reproductive Toxicology 4 (1989). 11This failure on the part of the Court of Appeals is und -r- standable. Judges have no expertise in toxicology and should there- 10 it can be harmed by exposure to a chemical substance (transported across the placenta) in much the same way that an adult can be affected, although the fetus may be more susceptible io the chemical’s toxic effects than a child or adult. The unborn child can also be damaged prior to conception when a chemical causes mutation in the genetic material of the sperm cell or the egg cell. Although such muiations may not affect the fetus in any significant way, they may well cause adverse effects that ear severely affect the life of the human being post par- tum.’* The first kind of adverse effect only occurs when a pregnant female is exposed to a toxic chemical. The second kind of effect can occur when either a male or a female is exposed. As a general matter, it cannot be said that one effect is more significant than the other, and for that reason it is impossible to conclude that ex- posure to a chemical that causes only the first kind of effect is riskier than exposure to a chemical that causes only the second kind of effect. Exposure to one chemical may present a high probability of a relatively modest consequence ‘e.g., slightly reduced I.Q.) while exposure to another chemicz! may pose a low probability of a dis- astrous consequence (e.g., hydrocephalus). In the ab- sence of a great deal of information about the relative probabilities and without some very difficult judgments about the relative severity of disease end-points, it is im- possible to conclude t! at one exposure poses a higher risk to the unborn human than the other. fore be cautious about drawing conclusions about the worthiness scientific data. This caution is especially warranted when the scien- tific information available to the court comes in the form of un- tested expert testimony in litigation affidavits. 12 See generally Note, FErclusionary Employment Practices in Hazardous Industries: Protection or Discrimination? 5 Colum. J. Envy. L. 97, 99-100 (1978). Dr. Legator’s desposition testimony, which must be accepted av true for purposes of a motion for sum- mary judgment, was that “lead is one of the very few chemicals ... that probably causes a genetic lesion during spermatogenesis.” Legator Deposition at 20. 11 The real world is more complex than the above example suggests. Exposure to a single substance may pose a risk of both kinds of adverse effects. Preconception exposure of either the male or female may pose a small probability of mutation leading to a grotesque malformity, while post-conception exposure of the female may lead to more modest health effects. Thus, the International Union’s claim with respect to lead exposure in the workplace is not at all fanciful. The post-conception scenario is rela- tively well-understood. Scientists know that lead passes from the mother's blood to the fetus at some time during pregnancy. Scientists also know that elevated lead levels in children are associated with various diseases ranging in severity from relatively minor adverse effects at low blood levels to more severe effects at high blood levels. The knowledge-base for these relatively strong scientific conclusions consists of human epidemiological studies, a large number of animal studies and occasional clinical observations. It is much more difficult to explore preconception tox- icity with epidemivlogical studies. Proper epidemiology would require knowledge about both the mother’s and father’s exposures and about all pregnancy outcomes, even though some mutations result in spontaneous abor- tions. This information is much harder to acquire. Scientists, regulatory agencies and courts are therefore forced to rely more heavily upon laboratory animal stud- ies as the knowledge-base from which to draw conclu- sions about the effects of preconception exposure to chemical substances. Reliance on animal studies is con- cededly more “speculative,” but it was wrong for the court to conclude that animal studies are not “convinc- ing’ or “solid” scientific data. When existing epidemio- logical studies do not provide adequate information on human exposures to the substance at issue, it is not at all “unscientific”? or ‘unreasonable’ to draw conclusions about human risks from existing animal studies. 12 8. Courts and Administrative Agencies Have Consist- ently Relied Upon Laboratory Animal Studies in Assessing the Risks of Chemicals to Humans. From the beginning of this century, Congress has enacted precatory statutes designed to protect the pub- lie health from the toxic effects of chemicals in food, the workplace and the general enivornment. The regulatory agencies that Congress created to implement these statutes have, with the approval and often active encouragement of the reviewing courts, consistently relied upon labora- tory animal studies in evaluating human risks. In the last two decades, governmental reliance on laboratory animal studies has become thoroughly interwoven into the regulatory fabric of our society. A partial list of federal laws in which animal studies are routinely used to assess human health risks includes: the Federal Insecticide, Fungicide and Rodenticide Act; "’ the Federal Food, Drug and Cosmetie Act ;'* the Consumer Product Safety Act: the Safe Drinking Water Act;" 7 USC. $ 136-137"; EPA routinely relies upon anima! data in reaching pesticides regulatory decisions, see, e.g. 40 C.F.R. Part 154.7 a1 2)(i) (“validated test data” used for cancellation deci- sions. due to carcinogenicity, teratogenicity or reproductive toxicity f<.m “effects demonstrated in humans or experimental animals”). 149] USC. $348(¢c)(3)(A) (no additive shall be deemed to he safe if it is found to induce cancer when ingested by man or animal.” ) 1515 U.S.C. § 2079(a) and the Federal Hazardous Substances Act $9(f)(1)(A), 15 U.S.C. § 1261, 1262. See e.g., 16 C.F.R. § 1500.17 (a) (10). and 43 Fed. Reg. 12308-12310 (animal studies are the basis for classification as banned hazardous substance of self- pressurized household substances containing vinyl chloride mon- omer). 16 42 U.S.C. $$ 300(f) et seq. See, eg., 44 Fed. Reg. 68624, Na- tional Interim Primary Drinking Water Regulations; Control of Trihalomethanes in Drinking Water: sufficient scientific evidence had been accumulated to con- clude that chloroform is an animal carcinogen as shown from 13 the Toxic Substances Control Act;'’ the Federal Water Pollution Control Act;'* the Federal Clean Air Act;'’ the a properly conducted bioassay and sheuld be presumed to be a risk to humans and that, as such, prudent public health pol- icy warrants reasonable measures to reduce human exposure. ... In the specific case of chloroform and other THMs, EPA had relied primarily on animal studies demonstrating the toxicology of chloroform. ... EPA has extrapolated from the results of animal studies to assess the risk posed by THMs to humans. Id. at 68627. 1715 U.S.C. §§ 2601-2629 (1976). § 2603(b)(2)(A) provides: The health and evironmental effects for which standards for the development of test data may be prescribed include carcino- genesis, mutagenesis, teratogenesis, behavioral disorders, cum- ulative or synergistic effects, and any other effect which may present an unreasonable risk of injury to health or the environ- ment. ... The methodologies that may be prescribed in such standards include epidemiologic studies, serial or hierarchical test, in vitro test, and whole animal tests,.... (Emphasis supplied); see also 40 C.F.R. Part 798 which specifies the use of numerous animal test procedures to determine chemical oncogenicity ($$ 798.3300, 798.320) and _ reproductive toxicity ($$ 798.5100-798.5955) for purposes of implementing $4 of the Act. iSFWPCA §$ 307(a), 33 U.S.C. $1317(a) (1976). See, eg., 41 Fed. Reg. 30476-77 (1976) and 42 Fed. Reg. 6532 (1977) (pro- posed and final discarges standards for PCBs based on evidence of animal carcinogenicity ). 18 42 U.S.C. § 7412. See, e.g. National Emission Standards for Hazardous Air Pollutants: Proposed Standard for Vinyl Chloride, 40 Fed. Reg. 69532 (December 24, 1975). (The rationale for the standard included animal test data demonstrating carcinogenicity of vinyl chloride as well as epidemiological studies.) See also, Na- tion Emission Standard for Vinyl Chloride, 40 C.F.R. Part 61, Subpart F. 14 Occupational Safety and Health Act;*” and the Resource Conservation and Recovery Act.” Under these statutes, the federal courts have uniformly recognized the need to regulate carcinogens and repro- ductive toxins on the basis of animal test results in the absence of definitive human epidemiological data. The plurality opinion of this Court in the Benzene case recog- nized the practical necessity of basing public policy deci- sions affecting public health on laboratory animal studies. The opinion observed that several “rational”’ techniques existed for determining whether human exposure to a ‘oxic substance in the workplace presented a “significant risk” of material health impairment and noted that “|iJn other proceedings, the Agency has had a good deal of data from animal experiments on which it could base a conclusion on the significance of the risk.” /ndustrial Union Dept., AFL-CIO v. American Petroleum Inst., 448 U.S. 607, 657 n.64 (1980). If, as the Court of Appeals in this ease maintained, evidence from animal studies is in fact “speculative” and “unconvincing,” it would have been disingenuous for this Court to have suggested that 2099 U.S.C. $655. See OSHA Cancer Policy which “establishes the criteria and procedures under which substances will be regu- lated by OSHA as potential occupational carcinogens.” 29 C.F.R. $ 1990.111(a). Positive results in high-dosage animal tests “will he used to establish the qualitative inference of carcinogenic hazard to workers.” 29 C.F.R. §$ 1990.143(g). See, e.g. 39 Fed. Reg. 95290, 35891 (1974), 38 Fed. Reg. 10929 (1973) (OSHA exposure standards for vinvl chloride and ethyleneimine, respectively, based on animal studies indicative of carcinogenicity ). 21 42 U.S.C. § 6901 ef seq. See 42 U.S.C. § 6421 and implementing regulations at 40 C.F.R. 261.11(a): The Administrator shall list a solid waste as a hazardous waste [if]... (3) it contains any of the toxic constituents listed in Appendix VIII .. . Substances will be listed in Ap- pendix VIII only if they have been shown in scientific studies to have toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life forms. (Emphasis supplied). 15 OSHA could meet the Court’s “significant risk” test by relying solely upon such evidence. The United States Court of Appeals for the District of Columbia has observed that the government has a ‘heavy burden’ to ‘explain the basis for . la] decision to permit the continued use of a chem- ical known to produce cancer in experimental ani- mals.’ [citations omitted’. When firm evidence es- tablishes that a chemical! is a carcinogen, statutes leave an administratee-no alternative but to step in and protect the public. Environmental Defense Fund, lnc. v. EPA, 598 F.2d 62, 88 (D.C. Cir. 1978. See also Environmental Defers Fund, Inc. v. EPA, 510 F.2d 1292 (D.C. Cir. 1975) Cup- holding the ban of the pesticides aldrin and dieldrin based upon carcinogenicity in rats and mice); Environmental Defense Fund, Inc. v. Ruckelshaus, 439 F.2d 584, 590 (D.C. Cir. 1971) (DDT); EDF v. Costle, 578 F.2d 337%, 345 (D.C. Cir. 1978) (court remanded to EPA regula- tions implementing the Safe Water Drinking Act that failed adequately to protect the public upon “ample evi- dence . . . our drinking water is contaminated with a large variety of organic substances, of demonstrated car- cinogenicity in animals”); Environmental Defense Fund, Inc. v. EPA, 548 F.2d 998, 1005-06 (D.C. Cir. 1976), cert. denied, 431 U.S. 925 (1977) theptachlor and chlor- dane) (court approved EPA’s use of “cancer principles” that “accept the use of animal test data to evaluate bu- man cancer risks; [and] consider a positive carcinogenic effect in test animals as sufficient to characterize a pesti- cide as posing a cancer risk to man... .”); Hercules Ine. v. EPA, 598 F.2d 91 (D.C. Cir. 1978) (EPA regulation of toxaphene and endrin under section 307 of the Clean Water Act, 33 U.S.C. § 1317): Society of Plastics Indus- try v. OSHA, 509 F.2d 1301 (D.C. Cir. 1975) ‘OSHA regulation of vinyl! chloride): Synthetic Orgqanie Chem, Mfrs. Assn. v. Brennan, 503 F.2d 1155 (2rd Cir. 1974) 16 (court upheld OSHA’s workplace exposure standard for ethyleneimine, upon its demonstrated carcinogenicity in mice and rats, noting “the extrapolation gathered from data in these rodent experiments to humans is justified by the report of the Ad Hoc Committee on the Evaluation of Low Levels of Environmental Chemical Carcinogens to the Surgeon General’); Bell v. Goddard, 366 F.2d 177, 180-81 (7th Cir. 1966) (court affirmed an FDA ban on diethelstil- bestrol (DES) as a poultry feed supplement on evidence of its carcinogenicity in test animals, noting “there is a histologically remarkable similarity between cancers of the endometrium in humans and animals”). ’ Judge Easterbrook, in his dissenting opinion in the Court of Appeals below, speculated that ‘t]he medical profession, like the Food and Drug Administration, will be stunned to discover that animal studies are too ‘specu- lative.” 886 F.2d at 919. Judge Easterbrook was right. Not only have the medical p: .ession and the Food and Drug Administration consistently relied upon animal studies to assess human health risks, but virtually every other federal agency charged with protecting the public health from hazardous chemicals has also extrapolated from “mouse-to-man” in evaluating human health risks. 'ndeed, it would be irresponsible for an agency charged with protecting health to do otherwise.** -- In his deposition testimony Dr. Legator gave an example of an instance in which the Environmental Protection Agency’s failure to act on the basis of animal studies on the pesticide DBCP resulted in sterility in workers exposed to that substance: With DBCP we had substantial information about the fact that this chemical at five parts per million caused testicular atrophy in a variety of animals. The study was generated in 1963. And basically we ignored the animal data, until the workers found an effect themselves in 1977. Leyator Deposition at 52. Upon discovering the human conse- qucpce, EPA cancelled the registration of DBCP. 50 Fed. Reg. 1122 (1985). OSHA promulated « standard to protect workers from DBCP in 1978. 13 Fed. Reg. 11514 (1978). 17 In promulgating its standard for workplace exposure to lead, the Occupational Safety and Health Administra- tion concluded: The record in this rulemaking is clear that male workers may be adversely affected by lead as well as women. Male workers may be rendered infertile or impotent, and both men and women are subject to genetic damage which may affect both the course and outcome of pregnancy... .”° In forming this conclusion, the agency relied heavily upon the very animal studies that the Court of Appeals in this ase summarily rejected on the basis of a summary judg- ment record devoid of cross-examination, peer review or any other validating technique. The United States Environmental Protection Agency in 1988 proposed guidelines for assessing male and fe- male reproductive risks “‘ and for assessing the risks of suspected developmental toxicants.** Both sets of cuide- lines rely heavily upon data from animal experiments in evaluating human risks. Under the “weight of the evi- dence” approach that the guidelines adopt for character- izing male reproductive risks due to chemical exposures, the guidelines posit that a “known positive” reproductive effect exists when “/a] convincing body of evidence exists that an agent causes an adverse effect on the male repro- ductive system in humans.” A “probable positive” effect exists when “{a] ecnvincing body of evidence exists that “Occupational Sefety and Health ‘dministration, Final Stand- ard for Oecupational Exposure to Lead, 18 Fed. Rey. 52952, 52966 (1T97R). “' Enviconmental Protection Ageney, Proposed Guidelines for Assessing Female Reproductive Risk, 53 Fed. Reg. 21834 (1988): Environmental Protection \e@enev, Proposed Guidelines for Assess- ing Male Reproductive Pisk. 53 Fed. Reg. 24850 (1988). ** Environmental Protection Agency, Proposed Amendments to the Guidelines for the Health Assessment of Suspect Developmental Toxicants, 54 Fed. Reg. 9386 (1989), 18 an agent causes an adverse effect on the male reproduc- tive system in nonhuman mammals.” 53 Fed. Reg. at 24863. While it is clear that human testing and epidemio- logical studies are the strongest evidence of male repro- ductive effects, the EPA has concluded that animal stud- ies alone are not “specuiative” or “unconvincing” evidence of human reproductive effects. The Guidelines for Developmental Toxicity address, inter alia, the risks that pre- and post-conception expo- sures pose to unborn humans.** One of the fundamental assumptions underlying the guidelines is that an agent that produces an adverse developmental effect in experimental animal studies is assumed to pose a potential hazard to humans following eX- posure during development. This assumption 1s based on the data for known human developmental toxi- cants. In almost all cases, the experimental animal data would have predicted a developmental effect in humans. 54 Fed. Reg. at 9390. The guidelines provide that ‘ade- quate evidence of potential human developmental toxicity exists where there is ‘data from an appropriate, well- executed study in a single experimental animal species that demonstrates developmental toxicity... .” 54 Fed. Reg. at 9399. It goes without saying that “adequate” evidence is not “speculative” or “unconvincing.” Clearly, the Court of Appeals’ conclusion that labora- tory animal data do not constitute “convincing scientific data” does not comport with the scientific judgment of 26 The guidelines define “developrnental toxicology” as “Ttlhe study of adverse effects on the developing organism that may re- sult from exposure prior to conception (either parent), during pre- natal development, or postnatally to the time of sexual maturation. _.. The major manifestations of developmental toxicity include: 1) death of the developing organism, (2) structural abnormality, (3) altered growth and (4) functional deficiency.” 51 Fed. Reg. at 9390-91. 19 the agency that Congress has charged with regulating environmental risks to human reproduction. The Equal Employment Opportunity Commission is- sued policy guidance to its investigators in the wake of the Court of Appeals’ decisions in this case that spoke directly to the use of laboratory animal data to assess human risks in both sexes: The majority in Johnson Controls rejected UAW’s animal research evidence, stating that it was “specu- lative,” “unconvincing” and not “solid scientific data.” . . . Commission investigators should not re- ject animal studies in such a wholesale manner... . These studies may in some cases provide the best available evidence to evaluate fetal or other human health hazards in the workplace. Certainly, the data from the animal research in this case, along with the other data provided, should have been sufficient to create a genuine issue of material fact warranting denial of summary judgment.” The Commission was clearly correct in telling its investi- gators not to fall into the trap that ensnared a majority of Court of Appeals in this case. The Commission correctly pointed out in its policy guidance that the question of the extent to which human health risk assessment should rely upon animal toxicity data was more properly the domain of the public health agencies like the Environmental Protection Agency and the Occupational Safety and Heaith Administration.” 27 Equa! Employment Opportunity Commission, Policy Guidance on United Auto Workers v. Johnson Controls, Inc., reprinted at p. 127a of the Appendix to the Petition for Certiorari. -* The Policy Guidance states: In determining whether the harm is mediated only through one sex, animal research should be considered along with other objective scientific evidence. The Commission will defer to pertinent findings by government agencies such as OSHA and 20 The reviewing courts, inclucing this Court, should heed this sage advice. Court are not well qualified, either technically or institutionally, to engage in wholesale science policy judgments of the sort that the Court of Appeals in this case mandated. As we have seen, vir- tually every federal agency that is charged with imple menting public health laws routinely relies upon animal testing data in assessing human health risks. This Court should defer to that expert judgment. CONCLUSION The International Union in this ease contends that Johnson Controls bas the burden of proving that its dis- parate treatment of women reflects a “bona fide occupa- ‘onal qualification.” If this Court accepts this view of the Jaw, then there is no need to address the use of animal studies in evaluating human reproductive risks. To meet the “business necessity” test adopted by the Court of Ap- neals én thts ease however, the International Union of- fered cvidenee from laboratery animal studies tending to prove thst lead exnosure to male humans at levels com- sayable te thes found in the Johnson Controls plant posed a significant risk of adverse effect to unborn chil- dren through mutations of the genetic material in sperm cells. The Internations! Union was not allowed to intro- duce this evidence in its legitimate attempt to persuade the factfinder that the overnll risk posed by male exposure i's roughly comparable ‘if not higher) than the risk posed by female exposure through transplacental passage of lend into the blood stream of existing fetuses In finding that the evidence from animal testing was “speculative” and “uneonvineing,” the Court of Appeals departed from a long-aecep ted and well-established practice of scientists NIOSH {the National Institute for Occupational Safety and W Ith Lp; pendix te the Petition for Certiorari at (an 21 reru) dtory paencics end yoviewin’ courts of usin anime! stud es to evaluate human health risks. Respectfully submitted, THOMAS O. MCGARITY Counsel of Record University of Texas School of Law 727 E. 26th Street Austin, Texas 78705 (512) 471-5151 ALBERT H. MEYERHOFF 90 New Montgemery San Francisco, CA 94105 Attorneys for Amicus Curiae --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385012_0705%3A19. Public record. Not legal advice.