Document DGqQKgJYb33Z62YeqemYgLzoQ

socma SYNTHETIC ORGANIC CHEMICAL MANUFACTURERS ASSOCIA 1075 CENTRAL PARK AVENUE. SCARSDALE. N. Y. 10583 (914 November 20, 1 The American Conference of Governmental Industrial Hygienists held Symposium in Tucson earlier this month dealing with "Protection of the Sen sitive Worker." The Symposium dealt with a wide variety of issues involving the identification and protection of the sensitive worker but one of the most important papers presented during the meeting summarized the legal issues in volved with protecting employees from reproductive health hazards. The paper was prepared and presented by Mr. Robert C. Barnard of Cleary, Gottlieb, Steen & Hamilton and it will be included eventually in the official Proceedings of the Conference. However, we have received permission to dis tribute a pre-publication copy of the paper to our membership and we strongly encourage you to forward it to those in your company's Legal Department in volved with this complicated issue. Sincerely, Enel. Cl Ronald A. Lang Executive Director b: A L 0 0 0 (> 4 5 9 (> 5' WASHINGTON OFFICE. 1612 K STREET. N.W.. WASHINGTON. D C 20006 (202) 659-0060 FROM: SOCMA/AIHC .Protection of the Sensitive Worker A Symposium Co-Sponsored by American Conference of Governmental Industrial Hygienists and Arizona Center For Occupational Safety and Health Legal Issues: Reproductive Health Hazards By Robert C. Barnard November 1, 1981 S' A i... 0 0 0 0 4 f:< 9 0 6 Legal Issues: Reproductive Health Hazards The program for this symposium refers to the "sensitive" and, sometimes'', to the "susceptible" worker. These are terms not defined in the law nor, indeed, in court, decisions. I propose, therefore, to divide my discussion of the legal issues into three sections: who is an "employee" under the OSH Act, interaction of Title VII of the Civil Rights Act and the OSH Act, decisions or regulations under the OSH Act. The Entities Involved Discussion of reproductive health hazards must be based on a clear understanding of the entities involved. There are issues which concern the male or female worker. But it is important to remember that there is a third entity to be con sidered - the fetus. The fetus may be susceptible to hazards which also affect the parent but may also be harmed by exposure which does not overtly harm the parent. Courts have upheld the right of a child to recover from injuries in utero. Cases have arisen primarily in the product liability area. It is important, therefore, in the discussion which follows to keep in mind the three entities concerned; the male worker, the female worker and the fetus. Who is an "employee" under the OSH Act Section 6(b)(5) of the OSH Act directs OSHA to develop standards for toxic or harmful agents that assure that "no employee will suffer material impairment of health or functional capacity... The language appears sweeping, but is it reasonable to assume SAL 00004!:j907 that it means that the standards must protect against all sensi tivities or susceptibilities? Does-the statute mean OSHA must adopt standards which will assure that a blind person driving a truck will suffer no impairment? Does a bridgeworker's job have to be made safe for those suffering from acrophobia? Does farm work in the sun belt have to be made safe for the person with xeroderma pigmentosa In order to construe the words of the OSH Act it is necessary first to look at the meaning of the term "sensitive worker." The term# which has come into both popular and regu latory use# appears nowhere in the statute# and the legislative history offers very little help in the definition. I suggest that the term "sensitive" is easier to understand in the employment context if you translate the word as meaning "limitation." There are several kinds of limitations affecting workers: limitations voluntarily incurred -- e.g., in creased risk of a smoker in relation to em ployment involving asbestos or radon daughters; genetic limitations - xeroderma pigmentosa is an example# physical limitations -- strength# height# eyesight, etc. I believe it is generally accepted that it is legitimate for an employer to establish criteria for employment which fairly measure and predict the performance on the job so long as the criteria do not run afoul of the non-discrimination provisions of Title VII of the Civil Rights Act. Thus an employer can specify, for example, reading skill, strength, height, eyesight and manual skills for employee selection so long as the criteria are not discriminatory. sal 00004590*3 Employment criteria may be health oriented. For example, Johns Manville has established a rule against em ploying smokers in its asbestos plants. There can be little doubt that this employment criterion is designed to deal with the health problems caused by the synergistic interaction of smoking and asbestos; the cancer risk to smokers is increased by a factor of 8 or 9 over non smokers. The Johns Manville rule had two parts. One part involved smoking by existing employees; this included psychological guidance and forbidding smoking in the plant area with sanctions escalating to dis missal. Part two established no smoking criteria for hiring. The Court of Appeals upheld an arbitration decision that part % one conflicted with the collective bargaining agreement --^; part two of the policy has not been challenged by the union or the government. In Boyce v. Reynolds Metals Co., 532 F.2d 638 (3th Cir. 1976) the court affirmed dismissal of a suit alleging dis crimination on the grounds of race. The court found that the employee was dismissed because his asthma condition made it impossible for him to work in the chemical plant. No contention was made that the plaintiff's asthma condition was not a proper basis for dismissal. The record in Boyce Indicated that the employer had taken reasonable steps to find another position for the plaintiff where he would not come in contact with the chemical fumes, but that none was available. Boyce supports 1/ Johns-Manville Sales Corporation v. International Assoc, of Machinists ,'"Local Lodge 1~6 09 BNA Daily" Labor Report" (No. (14 5") 0-1, July 25 , 1980". ^<>q4590<; -3- the proposition that termination of employment maybe justified where the employer was unable to provide working conditions to enable the employee to maintain his health. job criteria bearing on the subject of reproductive hazards have been upheld. In EEOC v. Olin Corporation, No. A6-78-186 (W.D.N.C. December 29,1980), the Federal District Court upheld an employment policy under which women of child bearing capability were not allowed to occupy certain job classifications in the plant because of possible harmful effects of certain chemicals on the unborn fetus. The plant classified workplaces into three categories: "restricted areas" where there was exposure to abortifacient or teratogenic agents# "controlled areas" where the contact with agents is limited and the exposure lower, and areas of unrestricted jobs. Under the policy, women of childbearing capability were barred from certain jobs in "restricted areas," Women were permitted to work in jobs in "controlled areas" after receiving counseling and upon promising to notify their supervisor if they became pregnant. The policy provided for review of job category as Olin succeeded in reducing exposure and the Court found Olin was making a good faith effort to reduce exposure levels and to reclassify jobs. Olin's policy did not exclude males from any jobs be cause of reproductive hazards. The Court found, however, that the Olin policy was legitimate (and nondiscriminatory) because ----, 1/ The case is pending on appeal by the EEOC. O -M 0 0. U. 0 vs,":'\C'*s \ the purpose of the policy was to protect the unborn and was based on sound medical knowledge. The "employment criteria may also be directed specifically at the protection of the fetus.. B. F. Goodrich Company adopted a corporate policy for the protection of the fetus from transplacental carcinogenesis. Under that policy an unmarried female of childbearing age (under 50) was transferred from a job involving exposure to vinyl chloride to another position. Subsequent voluntary sterilization would not, under the policy, be the basis for reinstatement. The transferred worker brought a sex discrimination suit and sought a preliminary injunction. Doerr v. B. F. Good- rich Co., 484 F. Supp. 320 (N.D. Ohio 1979) . The court refused an injunction on the ground that no irreparable injury was shown (the employee was retained and paid the same wage in the transfer position). The court also discussed the question whether the complainant was likely to prevail on the merits at a trial and concluded that she would not. In reaching that conclusion the court noted the company's position on potential liability because the mother cannot waive the rights of a child born with defects because of maternal exposure; held that the policy was supported by medical and scientific avoidance which demonstrated little likelihood the com plainant would prevail; rejected the claim that the policy was discriminatory because it did not deal with risks of male mutagenesis. Doerr subsequently filed a complaint with the Ohio Civil Rights -5- SAL 0000459:u. Commission. In a decision dated August 13, 1930 the Commission found no probable cause of discrimination and dismissed the complaint, Similarly, the State of Wisconsin Equal Rights Di vision upheld as non-discriminat-ory a hiring policy of BASF Wyandotte which barred women of childbearing age from jobs involving exposure to mercury because of the potential damage to the fetus. --2/ It is also interesting to note that as a condition for the use of Ferriamicide against fire ants, EPA provided that women of childbearing age are prohibited from applying that pesticide. 44 Fed. Reg. 11,111, 11,117 (February 27, 1979). Deputy EPA Administrator Barbara Blum defended the prohibition as an essential "trade off", and noted that a woman could waive rights as to her own exposure but could not waive rights of a child who may be injured. Finally, it is worth noting that both EPA and OSHA took action against the pesticide DBCP (dibromochloropropane) which, among other effects, caused male sterility. (EPA: Suspension Order and Notice of Intent to Cancel. 44 Fed. Reg. 65135 (November 9, 1979)); (OSHA DBCP final standard, 43 Fed. Reg. 11514 (March 17, 1978)). No issue of discrimination arose in those proceedings. Based on this discussion, I suggest that the term "no employee" in the OSH Act should be interpreted to mean "no worker who satisfies reasonable criteria for employment or _________________________________________ bAi... 0 0 0 0 4 9 1/ Carol A. Doerr v. B.F.Goodrich Company (3)-1-Q8-27-79 TrnwrrTT^TTf 052-)9-2498. 2/ Wisconsin Dept, of Industry, Labor & Human Relations, ERD Case No. 7800624. promotion." The interpretation I have offered suggests a reasonable meaning for the words "no employee" which might otherwise be s broad or vague as to raise a question of un lawful delegation of legislative authority by leaving too much to agency discretion. Under this interpretation an employer can adopt reason able criteria under which the employer can refuse to hire or promote workers, or can move or terminate workers, with certain limitations (or sensitivities). The job criteria must be soundly based and can include exclusion of women of childbearing age from certain jobs for medical reasons to protect the fetus * Interaction of Title VII of the Civil Rights Act and the OSH Act Title VII of the Civil Rights Act {42 U.S.C. S2000e) forbids discrimination in employment on grounds of race, color, religion, sex or national origin. The obligations of employers not to discriminate are spelled out in "Uniform Guidelines On Employee Selection Procedures" published by the Equal Employ ment Opportunity Commission, 43 Fed. Reg. 38290 (August 25, 1978) . Both Title VII and the Uniform Guidelines leave in tact the principles set out above regarding the legitimacy of hiring and promotion criteria based on sound medical or scien tific grounds. They also leave intact the decisions which permit an employer for sound medical reasons to exclude a woman of childbearing age from certain jobs. SAL 0000459:1. On February 1, 1980 the EEOC and the Department of Labor proposed Interpretative Guidelines on Employment Dis crimination and Reproductive Hazards, 45 Fed. Reg. 7514. Those guidelines proposed to establish the principle that dis crimination on the basis of sex includes discrimination based on pregnancy o_r childbearing capacity. The proposed guidelines would have set up an elaborate structure of testing both male and female workers before an exclusion policy would be per mitted and required an affirmative showing of no reproductive hazards to workers of the sex not excluded. The proposed guidelines were based on two concepts: it is discriminatory to exclude workers of one sex from a known reproductive hazard until tests have shown that there are no reproductive hazards to workers of the other sex, the fetus was not recognized as a separate subject for protection. Hazards to female workers and to fetuses were assumed to be identical. There was extensive' public comment on the point that the pro posal would have prevented protection from known hazards to one sex or to the fetus while tests went on concerning possible hazards to the other sex. The proposal was also based on a determination of questionable scientific validity: hazards to the fetus were not distinguished from hazards to the mother as a valid basis for occupational rules. The proposed policy ignored liability to a child injured by exposure, a liability the mother could not waive. The proposed guidelines were with drawn January 16, 1981. 46 Fed. Reg. 3916. Thus, a job criterion which is soundly based on pro tection of the fetus remains valid under Title VII. It follows also that a job criterion involving a validly demonstrated re productive hazard to males only or to females only would also be valid. ,,, -8- Regulations and Decisions Under the OSH Act In two recent cases the Supreme Court upheld the OSHA Cotton Dust standard and refused to review the decision of the Court of Appeals upholding the OSHA Lead' standard. --^ Each of these standards has provisions which have some bearing on the question of the protection of the sensitive worker. The Lead standard specifically addresses issues of reproductive hazards. Unfortunately, the susceptible worker provisions in the Lead and Cotton Dust standards were not central issues in those cases. The decision of the Supreme Court in Cotton Dust and the decisions of the District of Columbia Circuit Court of Appeals on both standards only glanced at the question. --^ OSHA's authority to set standards covering susceptible workers will remain at least somewhat unclear until the Supreme Court or Congress speaks on this issue. Cotton Dust. The standard required employers to grant to employees who could not wear a respirator the opportunity to transfer to another position if available. The standard 1/ American Textile Mfqrs. Institute, Inc. v. Donovan, 49 d.'S.DTW;' 47205" "(1931);------------------------------------ --------------- 2/ United Steelworkers v. Marshall, 592 F.2d 893 (D.C. Cir. 1980) cert_denied "sub. nom Lead Industries Association, Inc, v. Donovan, 49 U.S.L.W. 3964 (1981). 3/ The Court of Appeals in a footnote rejected a contention by an amicus curiae that medical removal provisions are required by the OSH Act to prevent sex discrimination by exclusion of fertile women from certain jobs. The Court held that an OSHA proceeding is not the place to address hypothetical Title VII questions id. at p. 1238 n. 74. -9- also required the employer to guarantee no reduction in wages or benefits due to the transfer. 29 CFR 1910.1043 (f) (2) (v) (1980) . The _transfer provisions were not challenged and neither the Court of Appeals nor the Supreme Court disturbed them. The Supreme Court did# however, strike down the wage guarantee- be cause OSHA had failed to make the necessary findings justifying it as a safety or health measure. The worker unable to wear a respirator is "susceptible" under the definition proposed above because the inability is a limitation. Neither the Court of Appeals nor the Supreme Court focussed on the scope of OSHA's authority under 6(b)(5) to provide protection for susceptible workers or the employer's right to establish employment criteria excluding such workers-; It is interesting to note that in Questions and Answers published after the noise standard (29 C.F.R. 1910.95 (1980)), OSHA in response to questions about an employee who could not wear protective equipment asserted without discussion that an employer may not expose the employee to excessive noise levels. OSHA did not answer the critical question whether an employer could dismiss such an employee if he could not provide working conditions to enable the worker to maintain his health. (Q's & A's to Part. 1910, OSHA 2095 (December 1973) reprinted in Empl. Saf. and Health Guide (CCH) 1119.69.) Lead. In the rulemaking, OSHA concluded that exposure to lead has severe effects on the reproductive capabilities of males and females. OSHA identified genetic, gametotoxic, intra uterine and extrauterine effects from lead exposure. It con cluded that the fetus and newborn are sensitive to lead; the SAL 0000459X6 -10- former through transplacental passage from the mother and the latter from lead In breast milk. (43 Fed. Reg. 52952, (November 14, 1978); Attachments to the Preamble to the Final Standard, 43 Fed. Reg. 54354 , 54398, (November 21, 197.8),) Discussing its duty to deal with these adverse health effects, OSHA made the following statement: "OSHA must promulgate a standard which prevents occupational disease resulting from both acute and prolonged or chronic exposure to lead? it must like wise guard against the onset, progression or severity of chronic degenerative diseases of aging workers. The degree of protection to be provided must extend over the full span of a working life and must cover the more susceptible, as well as the more robust members of the exposed group.'1 (43 Fed. Reg. 52963/329?4/11 (Emphasis added.) OSHA views of its authority to protect the fetus because damage to the fetus is an impairment of the female worker's health and its views on the limitations of its authority were further set out in the statement: "OSHA believes that damage to the fetus represents impairment of the reproductive capacity of the lead exposed parent. While OSHA believes that a standard should be set which protects all persons affected -- male and female workers, and the fetus -- the agency is limited by the requirement that a standard be feasible.H (43 Fed. Reg . 52966/1) (Emphasis added .) OSHA did not address the separate issue of protection to the fetus as a separate entity. In the Attachments to the Preamble published after the standard, OSHA referred to the effect of lead exposure on "particularly sensitive individuals" and identified those with sickle cell traits as one large subgroup of sensitive individuals. The effects on these individuals "must be considered" OSHA said "in the promulgation of this standard" (43 Fed. Reg. at 54361/2). -11- 'HI 0000459 Based on this background of findings, OSHA established an across-the-board permissible exposure level (PEL) of 50 micrograms of_lead per cubic meter of air (50 ug/m3) averaged over an eight hour period. The Agency acknowledged that the PEL will not maintain blood levels which it had determined were necessary to protect pregnant women or workers planning preg nancies; a lower level (30 ug/m3) was necessary to protect these workers but the agency found a standard at the lower level was not feasible. (43 Fed. Reg. at 52966/1). There was no discussion of levels necessary to protect sub groups of sensitive workers such as those with sickle cell traits. The Agency maintained that despite the inadequacy of the standard to protect pregnant women or workers planning pregnancies, adverse reproductive affects on these workers would be minimized by the following provisions: (1) biological and air monitoring above an action level of 30 ug/m3 (2) medical surveillance and a medical re moval program (3) an education program for the workers. (43 Fed. Reg. at 52966/1 and 2). The Medical Removal Program (MRP) is the most radical plan OSHA has promulgated to deal with adverse medical effects and was regarded by OSHA as a precedent-setting regulatory ex periment. Under the MRP, workers must be removed (not trans ferred when a position becomes available) where there is a medical determination that the employee has a "detected medical condition" that places him at "increased risk of material im- -12- pairment to health from exposure to lead." ` 29 C.F.R. 1910. 1025(k) (1) (ii) (1980). The employer is required to maintain the employee's benefits and wages until the medical condition is cleared up for a maximum period of 18 months. These provisions apply, even if there is no job for the employee. The Court of Appeals upheld the provisions of the standard including those relating to reproductive effects and medical removal. 1/ The Court concluded that the record supported OSHA's finding that lead exposure had reproductive effects on males and females and it accepted OSHA's contention that it had authority to protect "working mothers" since harm to fetuses "is a material impairment of the reproductive systems of parents." 2/ The Supreme Court refused to review the Lead ^ case. 2/ Several points should be made about the Lead case: (1) The Court of Appeals did not address hiring or promotion criteria? (2) the Court of Appeals did not discuss sensitivity except as relates to male/female differentiation and the court did not distinguish the fetus as a separate entity; (3) the Court of Appeals did not consider whether a single standard could be set if the record supported the conclusion that the level of significant risk is different for men than for women or fetuses. (OSHA rejected the contention that there was such a difference with respect to lead exposure and the Court upheld OSHA's finding.) X/ United Steelworkers v. Marshall, 592 F.2d 893 (D.C. Cir. 1980) cert "denied ~sub. nom Lead Industries Association, Inc . v. Donovan , 4 9 U. S . L- 3 9(34 (T981) . 2/ Id. at 1256. 3/ 49 U.S.L.W. 3964 , June 30 , 1981 . ,,Al_ 00004591* -13- (4) neither OSHA nor the Court of Appeals tried to define the "increase" in risk necessary for medical removal. Removal is a case-bycase matter so the Court did not consider " whether there must be a finding of sig nificant increase in risk under the Supreme Court's Benzene decision. A/ . (5) nor did the Court of Appeals consider OSHA's assertion that the Medical Removal Program applied to workers planning a pregnancy. It is difficult to see how the necessary "detected medical condition" determination can be made with respect to an anticipation. General Duty Clause. In addition to the duty to comply with standards, the OSH Act imposes a general duty on an employer to furnish "to each employee" a work place "free from recognized hazards that are causing or likely to cause death or serious physical harm to his employees." 29 U.S.C. 654(a)(1). The impact of this clause on the employer's duty to employees susceptible to reproductive hazards has not been explored in any detail in the courts or by commentators. Two reasons can explain this omission: (1) the legislative history made clear that the general duty clause is meant to be an extra ordinary regulatory tool to be applied only where standards do not exist; (2) application of the clause is appropriate only (a) where the hazard is recognized by the employer or generally recognized by the industry, and (b) feasible abatement measures are available. A recent decision of the Occupational Safety and Health Review Commission dealt with reproductive hazards and 1/ Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607 (T$$0) . See also Pratt & Whitney" Aircraft v. Secretary of Labor and OSAHRC, (9 O.S.H.C. 1554 at 1558-61, (2d Cir . 1981) (violation of a safety standard requires showing of "significant risk"). -14- * the general duty clause. Because decision of a different issue disposed of the case, the OSHRC had no occasion to con sider the scope of the employer's obligation under the general duty clause. That case involved an employer's policy of excluding from certain jobs women of childbearing age who had not been sterilized. The policy was adopted to protect fetuses from the teratogenic effects of lead, a protection which went beyond OSHA's lead standard and which the employer concluded was neces sary to protect fetuses. The Commission held that the general duty clause does not prohibit certain voluntary employer action to reduce re productive hazards. The Commission rejected an argument that the policy was a health hazard because it pressured women em ployees to undergo sterilization which reduced their functional capacity. The statute applies to occupational hazards operating directly on the employee at work. The sterilization procedure, the Commission concluded, was external to the workplace and therefore could not be an occupational hazard. Conclusion Both EPA and .the NRC have had occasion to consider imposition of restrictions to protect women or fetuses (EPA pesticides, NRC radiation). However, the main developments have been under the OSH Act. The law on the subject of sensitive 1/ American Cyanamid Co., OSARC Docket No. 79-5762, 9 OSHC Id93 (April 'll, 1981) , appeal docketed No. 81-1687 (D.C. Cir. July 1981} . SAL 00004w937 -15- * workers and reproductive hazards is far from well developed. However, certain conclusions seem possible. Criteria or policies which have the effect of excluding certain sensitive workers from the work place are nondiscriminatory if soundly based on medicine or science. An employer can dismiss a "sensitive" worker he cannot protect in the absence of a transfer provision such as that in Cotton Dust or the medical removal provision in Lead or restrictions in a collective bar gaining agreement. A soundly based policy can be based on pro tection of the fetus as an entity? an em ployer can exclude women of childbearing capability from certain jobs where the ob jective is the protection of the fetus and the OSHA standard is not adequate to accomplish tha objective. OSHA's assertion of authority to set a single standard has been upheld with respect to a male/female/fetus hazard where the record supported the OSHA finding of hazard to all above the exposure level allowed by the standard. The courts have not addressed OSHA's con tention that a standard must protect a sub group which is genetically or physically sensitive for reasons other than sex. The courts have not faced the question whether OSHA has authority to adopt a single standard if there is a difference in the level at which males, females or fetuses are significantly affected. OSHA acknowledges that its authority to set standards to protect the sensitive worker is limited by feasibility. The general duty clause has very limited application in dealing with potential harm to a fetus. -16- SP,L 000045922 June 1981 Vol. 23 No. 6 Guidance for the Evaluation, Risk Assessment and Control of Chemical Embryo-Fetotoxins Bruce W. Karrh, M.D.; Thomas W. Carmody; Robert M. Clyne, M.D.; Kenneth G. Could, M.O., Ph.D.; Gloria Portela-Cubria, J.D.; Jerry M. Smith, Ph.D.; and Milton Freifeld The recognition, evaluation, and control of embryotoxins in the workplace are toxicologically and administra tively complex and present challenging circumstances to the occupational health professional and to the workplace manager. Accommodating the expectations of society and complying with existing laws and regulations make this comp/ex problem even more difficult By carefully apply ing the same toxicological considerations and control measures as are used for other chemica/s which present different toxic hazards, exposures of susceptible persons to embryotoxins can be prevented or maintained at safe levels without unnecessary restriction of the opportunity for meaningful employment for any class of persons. Concern for the unborn has generated tremendous pressure upon industry and regulatory agencies to pro vide effective control of potential chemical embryo-fetotoxins. The issue in regard to exposure to embryo-fetotoxic chemicals is protection of the susceptible embryofetus from chemical substances which can cross the placenta and cause damage to the embryo-fetus, almost always at concentrations which would have no adverse effect on the female or the male adult. It is not a matter of female employees being more susceptible than male employees or of female employees being at greater risk of adverse health effects.from exposure. Nor is it an issue of sex discrimination against the female employee. The Prom .1. duPont de Nemours & Co., Medical Division N-11400, Wiimington. DE 19898 (Dr Karrh, Chairman); Union Carbide Corporation (Mr. Carmody); American Cvanamid Company (Dr. Clyne. Committee Liaison); International Paper Company (Dr. Couldt The Standard Oil Company of Indiana (Dr. PorreiaCubna); and Rohm and Maas Company (Dr. Smith). Presented at the 1979 Joint Conference on Occupational Health. Sept 27. 1979. Minneapolis. Minn. Journal of Occupational Medicine/Vol. 23, No, 6/June 1981 woman at work is involved only because she is capable, and uniquely so, of becoming pregnant and bearing children. The determination of the intrinsic embryo-fetotoxic potential of a chemical and the estimation of risk from ex posure are scientific endeavors, while the acceptability of an estimated embryo-fetotoxic risk for the unborn to a given exposure is a societal and regulatory decision. Scope of the Problem The discussion which follows will provide general guidance for evaluating the quality of data, assessing its significance, and controlling the degree of risk of expo sure to embryofetotoxic chemicals. It will be neither allinclusive nor specific, but will recognize the requirements for sound scientific judgment for each suspect chemical. It will not address either male or female gonadal toxins or mutagens, but will be concerned with the conceptus, em bryo, or fetus. The importance of the legal considerations involved will also be summarized. An embryo-tetotoxin is defined as a chemical which manifests an effect upon the conceptus during any of the stages of gestation, from fertilization until birth. It may induce death, structural malformations, metabolic or physi ological dysfunction, growth retardation, or psychologi cal and behavioral alteration which is manifest at birth or in the postnatal period. Death of the embryo, fetus, or newborn is included. The definition does not include inutero induced carcinogenesis and abnormalities reflect ing mutagenic effects. This definition is consistent with the Environmental Protection Agency definition of terato gen as contained in the Code of Federal Regulations. In assessing the risk of exposure to embryo-fetotoxic chemicals two basic toxicological principles must be con sidered. b H l... 397 1. Risk is a function of both the intrinsic embryo-fetotoxic potential of the chemical and the degree of expo* sure to the chemical. 2. A dose-response relationship holds for each embryofetotoxic response and there exists a threshold exposure level (dose) for each chemical below which no effect is to be expected. Medical Issues Recent surveys indicate that up to 7.5% of all deliv ered infants have developmental abnormalities that inter fere with their survival or result in clinical disease. Selec tive elimination of many malformed human ova, em bryos, and fetuses occurs either soon after conception (between the second and seventeenth days) or by sponta neous abortion of the fetus before the twenty-second week of gestation. More than one-third of all embryos die before recognition of pregnancy, and about 15% of rec ognized pregnancies abort spontaneously. It has been estimated that about 40% of those lost embroyos and fetuses would have been malformed had they survived. Historically, lead has been used as an abortifacient. At the turn of the century women workers in the lead indus tries were known to have decreased fertility and an in creased abortion rate, along with symptoms of lead poisoning. This led to the widespread enactment early in the twentieth century of labor codes forbidding the em ployment of women in industries involving a lead hazard. In 1956 Minamata disease was described and by 1959 its cause had been proven. The expectant mother with this disease could not have become pregnant if her methyl mercury intake was so great that she became acutely ill. At a lower dose, the woman might have be come pregnant and the child might have been spontane ously aborted or bom dead. At even lower doses, the child might have been bom with congenital Minamata disease, evidenced by neurologic symptoms. Maternal alcoholism is thought to be the leading known cause of teratogenic effects in humans but the full extent of its effects is unkown. Twenty percent of all birth defects are estimated to have been caused by known genetic transmission. Chromosomal aberrations cause 3 to 5% of such defects and radiation, both therapeutic and nuclear, accounts for less than 1%. Infections, in cluding rubella, cytomegalic inclusion disease, herpes simplex, toxoplasmosis, and syphilis, account for 2 to 3%. Maternal metabolic imbalances, such as endemic cretin ism, diabetes, phenylketonuria, and virilizing tumors, ac count for 1 to 2%. Drugs and environmental chemicals, including androgenic hormones, folic acid antagonists, thalidomide, organic mercury, some hypoglycemics and some anticonvulsants, account for 2 to 3%. Causes of the remaining 65 to 70% are unknown. The thalidomide experience of the 1950s aroused much interest in teratogenicity and increased the determination to identify teratogens in advance in order to prevent similar experiences in the future. For instance, the FDA now requires animal teratogenicity studies on all new drugs and the EPA requires these tests on agrichemicals if "the product use may reasonably be expected to result in exposure to human females, or if use may result in resi dues in food or feed." The human embryo is most sensitive to teratogens dur ing the period of organogenesis (eighteenth through 60th day of gestation). The most critical period is during early differentiation (eighteenth through thirtieth day). At this time, the woman usually does not know that she is preg nant for there is no reliable method for ascertaining human pregnancies earlier than three weeks after concep tion. Severe injuries during the first 17 days after fertiliza tion will usually result in death of the fertilized ovum. Lower-level exposures to some substances for longer periods of time may produce abnormalities which are not obvious at birth but which may be noted months or years after delivery. During the period of advanced differentia tion (after 60 days) the susceptibility of the fetus to terato genic agents affecting structure lessens rapidly. Assessment of Intrinsic Embryo-fetotoxic Potential The intrinsic embryo-fetotoxic potential of a chemical for a given species is dependent upon the toxic properties of the chemical and of its metabolites. The response may be modified by the defense mechanisms of the host and of the target embryo. The assessment of the intrinsic embryo-fetotoxic potential of a chemical requires sound scientific data and the judgment of scientists who have appropriate training and experience. After reliable data are developed, their relevancy must be scientifically evaluated. The numerous factors to be considered include the following. 1. Response a. Type (e.g., structural, biochemical, functional) b. Severity (e.g., life threatening, incapacitating, revers ible) c. Relativity (e.g., ratio to other toxicity, primary or sec ondary effect) 2. Dose-Response a. Threshold exposure level b. Slope of the dose-response curve c. Critical time of dosing 3. Route of Exposure a. Inhalation b. Dermal c. Oral 4. Biological Variation a. Biochemical toxicology b. Target site c. Species (strain) d. Type of placenta 5. Biochemical Toxicology a. Absorption b. Distribution c. Biotransformation d. Excretion 6. Biometrics a. Sensitivity of study b. Limitation of study 7. Host Response a. Biochemical b. Physiologic Si-tl ;') 0 0 0 4A'".O' c. Pharmacologic d. Pathologic e. Immunologic f. Tissue and biochemical repair 8. Replication of results 9. Number of species involved 398 Guidance for the Evaluation of Chemical Embryo- Fetotoxins/Karrh et, Assessment of Human Exposure Human exposure in the workplace is controllable. Understanding the degree and nature of the potential ex posure permits some measure of control of risks associ ated with a chemical which has intrinsic embryo-fetotoxic potential. Assessment of the exposure includes evaluation of the following. 1. Physical Properties of the Chemical a. Solid b. Liquid c. Cas d. Aerosol e. Dust f. Vapor pressure g. Melting point h. Boiling point i. Solubility 2. Route of Exposure a. Respiratory (inhalation) b. Percutaneous (dermal) c. Gastrointestinal (oral) 3. Dose a. Concentration b. Volume 4. Characteristics of Exposure a. Frequency b. Continuous c. Intermittent d. Duration e. Details of the process 5. Population at Risk a. Age b. Sex c. Health d. Occupation e. Number Assessment of Risk Following the evaluation of the intrinsic embryo-feto toxic potential of a chemical, an assessment of risk based on scientific principles must be made. Most critical to this judgment are the following questions. 1. Does the embryo-fetotoxic response occur in more than one species? 2. Does the embryo-fetotoxic response occur at expo sures substantially below exposures which produce other, nonteratogenic toxic effects? 3. Do the data indicate a dose-response relationship? 4. Has the test been done in the most appropriate ani mal model for the class of chemical evaluated and in an exposure route applicable to man? 5. What are the threshold and the no-observable-effect levels of exposure for the animal model? 6. What populations are at risk (exposed) and what characterizes the exposures? Estimation of Acceptable Exposure Levels Following assessment of the embryo-fetotoxic poten tial of the chemical, the potential for human exposure, and the risk, an acceptable exposure level should be esti mated, taking into consideration the degree of confi dence in the data and the variability and nature of the population at risk. Where acceptable exposure levels can be estimated, they should be accompanied by documentation and statements of rationale. Control of Chemicals Posing a Potential Embryo-Fetotoxic Risk When it has been determined that a substance presents a risk of embryo-fetotoxicitv, the following actions should be considered. 1. Employees who may be affected should be informed of the possible consequences of exposure to such sub stances and appropriate safe handling procedures should be established and communicated. 2. Engineering controls should be used to the extent practical to reduce and to maintain at acceptable levels exposure to embryo-fetotoxins. Such controls should be augmented by administrative controls as appropriate. 3. Whenever further engineering and administrative controls are not practical to keep exposures at or below acceptable levels, the use of personal protective equip ment should be required where appropriate. Employees who are required to use such equipment should be ade* quateiy trained in its proper use. 4. Where there is potential for exposure to an embryofetotoxin for which an acceptable exposure level cannot be set due to inadequate data, women of reproductive potential should be excluded from the work area. 5. Where engineering and administrative controls, aug mented as appropriate by personal protective equipment, are determined to be inadequate to ensure acceptable levels of exposure to an embryo-fetotoxic compound, women of reproductive potential should be excluded from the work areas. Legal Issues Many legal issues in various specialized areas are in volved in the evaluation, risk assessment and control of embryo-fetotoxins. For example, there are a number of equal employment opportunity matters to be considered when a company concludes that it must exclude women of reproductive potential from workplace areas as a means of controlling exposure. The company may be called upon to demonstrate that the embryo-fetotoxic effect is due to exposure of the em bryo or fetus during gestation and not due to toxic effects on the mother due to the exposure during pregnancy. If only women of reproductive potential are excluded, the employer may have to demonstrate that the toxic effects result only from in-utero exposure of the embryo or fetus and not from preconception exposure by either parent. Consideration must be given to what constitutes suitable alternate assignments and compensation for employees excluded from certain jobs because of potential expo sures. Company counsel should be sought at an early date on these and ail other legal issues which may be involved. Journal of Occupational Medicine/Vot. 23, No. 6/June 1981 399 RECEIVED i361 Donald L. Norwood To R. E. Lehmkuhl D. A. Kuhn J. A. DeBernardi J. Friend C. L. Miller (conoco) Attached for your information. 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