Document nmr6yRZojqmx9wnLOqD868L36

ER-541 Editor: Mary P, Kilcoyne RECEIVED December 1, RI95 1930 FEDERAL LEVEL ENVIRONMENTAL PROTECTION AGENCY Mutagenicity Risk Assessments Proposed Guidelines Guidelines for mutagencity risk assessments were issued by the Environmental Protection Agency for public comment (Federal Register, November 13, 1980, pp.74984-8, attached). EPA has developed guidelines to be used in evaluating the risks associated with human exposure :to chemical mutagens and has created the Reproductive Effects Assessment Group in its Office of Research and Development. This group will have the respon sibility for oversight of the agency's risk assessment activi ties. The assessments will be carried out according to the guidelines, which will be applied in a two-step process: First, the mutagenicity of a chemical will be determined; and second, it will be determined whether the chemical reaches or affects the gonadal organs. The results of these evaluations will be combined with human exposure information to determine the extent of-mutagenic risk. According to the Environmental Protection Agency, at least 107. of all human disease is genetically related. Such diseases re sult from changes in the composition or arrangement of genes and chromosomes. Some of the chemicals that are being released into the environment have been shown to have mutagenic effects on test animals and are assumed to have a potential for causing genetic damage to the human population. Many of these chemicaLs are widely used-in drugs, food additives, cosmetics, industrial compounds and pesticides. Comments on the Guidelines should be submitted by February 11, 1981 to: Reproductive Effects Assessment Group (RD-689) Office of Health and Environmental Assessment Environmental Protection Agency 40L M Street SW Washington, D.C. 20460. A L 0 00 0 4 5 9 2 8 THE SOAP AND DETERGENT ASSOCIATION 475 Park Avenue South, New York, N.Y. 10016 (212)725-1262 74984 Federal Resistor / Vol. 45, No. 221 / Thursday, November 13. 1980 / Notices Environmental Protection Agency, Rm. -124. 401M St, SW., Washington. D.C. 20M0.(202~420~223). SUPPLEMENTARY INFOftMATKMC Flax does not compete well with weeds; weed infestations result In poor stands of flax by reducing germination and competing with the developing flax plants. Wild oats and foxtails are common weed pests of flax. According to the Applicants, these weeds are present in all areas where flax is produced,-and due to heavy snowfall this past winter, heavy weed growth delayed planting and shortened the time For use of preplent herbicides. Eptam, Avadex. Dalapon. Carbyne, MCP Amine and Bromoxynil are registered for selective weed control in flax. According to the Applicants, the registered alternative pesticides are either not effective or are not acceptable control methods for wild oats, wild buckwheat and foxtails for this season's wet conditions, Minnesota reports that Kittson, Lake of the Woods, Marshall. Pennington, and Roseau Counties, where flax is a major crop, grow from 75.000 to 95.000 acres of fiax annually. Significant losses in agricultural income may be incurred, die Applicants claimed, if the exemptions were not granted. North Dakota reports that Bottineau. Cavalier, Pierce, Pembina, Rollette, and Towner Counties annually grow about 38.000 acres of flax. The Applicants proposed to use an. usulam formulation. Asulox, EPAReg. No. 359-662, in a single post-emergence application when wild oats are in the three- to four-leaf stage. Applications will be made by both private and commercial State-certified applicators using both ground and air equipment in Minnesota and ground equipment only in North Dakota in the counties named above. ' EPA has determined that the available data are adequate to support the proposed use of Asulox on flax. Residues of the active ingredient (a.l.) asulam are not likely to exceed 2.0 parts per million (ppm) in flax seed and its fractions or 2.5 ppm in flax straw. EPA has deemed these levels to be adequate to protect the public health. Appropriate crop rotation restrictions have been imposed. No unreasonable adverse effect on the environment from this use of asulam is anticipated. After reviewing the application and other available information, EPA has determined that the criteria for exemptions have been meL Accordingly, the Applicants have been granted specific exemptions to use the pesticide noted above until October 31. I960, to the extent and in the manner set forth in"' Dated: November 8,1980- the applications. The specific James M. Conion. exemptions exe also subject to the Associate DeputyAssistantAdministratorfor following conditions: Pesticide Programs. 1. A single post-emergence application of Asulox (EPA Reg. No. 359-602) is authorized. ]FX Doc. 60-3S270 Film) BHXWM COM tUO-3Hi I W cm) 2. Application shall be made by air and/or ground equipment in Minnesota (BP FRL 1563-2) and by ground equipment in North Dakota, at a rate not to exceed 1.25 pounds a.i. per acre. Mutagenicity Risk Assessments; Proposed Guidelines 3. A maximum of 10.000 gallons of October 30,1980. formulation may be applied to 32,000 agency: Environmental Protection acres of flax in the five Minnesota Agency. counties mentioned above; a maximum of 68,000 acres'of flax in the six North Dakota counties named above may be action: Proposed guidelines for Mutagenicity Risk Assessments. treated. SUMMARY: The Environmental Protection 4. Applications will be made when Agency has developed Guidelines for wild oats are in the 3-4 leaf stage, Mutagenicity Risk Assessments 5. All applications shall be made by (Guidelines). These Guidelines will be State-certified private and commercial used within the policy and procedural applicators. framework provided by the various 6. Precautions 6hall be taken to avoid statutes which EPA administers, to or minimize spray drift from target area. guide Agency analysis of mutagenicity Application may not be made when data. weather conditions favor spray drift These guidelines were developed by 7. Residue levels of asulam are not an Agency-wide working group, under expected to exceed 2.0 ppm in flaxseed the direction of the Reproductive Effects and its fractions (meal oilseed cake, Assessment Group (REAG). REAG Is an refined oil. and soapstock) and 2.5 ppm advisory body located within the in the flax straw. The Food and Drug Agency's Office of Research and Administration, U.S. Department of Health and Human Services, has been Development, which serves es the senior Agency technical review group for advised of these actions. Any resulting residues in meat, milk, poultry, and eggs will be well below detectable levels (0.05 ppm in meat 0.025 ppm in milk, and 0.1 ppm in poultry tissues and eggs). 8. Crops other than small grains may not be planted in the treated area within 12 months of application. Small grain crops may not be planted within ten months of application. Root crops may not be planted in the treated area within 18 months of application. Fodder from grain crops rotated to treated flax fields may not be grazed or cut for forage. 9. Alt applicable directions, restrictions, and precautions on the EPA-registered label must be followed. 10. Application of Asulox to flax may result in crop injury and reduction in yield under stress conditions or if the mutagenicity assessment performed by Agency program offices. A preliminary draft of the Guidelines was sent for review to approximately 30 scientists hi the field of chemical mutagenesis within government, universities in the United States and abroad, and the private sector. In general, the comments received were favorable, and changes in the draft were made, as appropriate, in response to them. In addition to soliciting public comments on the Guidelines by publication of this Federal Register Notice, the Agency is providing them to the Agency's Science Advisory Board for review. FOR FURTHER INFORMATION CONTACT Dr. Donna Kuroda, 202/426-2275. OATES: Comments must be submitted by herbicide is applied at stages of growth February 11. I960. other than those specified. adoress: Reproductive Effects 11. The EPA shall be immediately Assessment Group (RD-689), Office of informed of any adverse effects Health and Environmental Assessment, resulting from the use of Asulox in Environmental Protection Agency. 401M connection with these exemptions. Street SW.. Washington, D.C. 20460. 12. Each Applicant is responsible for ensuring that all of the provisions of ita SUPPLEMENTAL INFORMATION! specific exemption are met and each !. Introduction must submit a report summarizing the As a result of the progress In the results of this program by January 19, control of Infectious diseases, increase 1981. In average human lifespans, and better (Sea 18 as amended 92 Stat. 819: (7 U5.C, procedures for identifying genetic . 138)) disorders, a considerable heritable Federal Register / Vol. 45, No. 221 / Thursday, November 13, I960 / Notices 74985 genetic disease burden has been natural and man-made environmental recognized in the human population. It is agents may have increased the amount estimated that at least 10% of all human of genetic damage in the present human disease is genetically related, resulting. population and contributed to the from changes in tbe composition or mutational "load" that will be arrangement of genes and chromosomes transmitted to future generations is (1.2). Such genetic diseases can lead to unknown at this time. Since the prospect structural or functional health of curing most heritable diseases caused impairments. Moreover, many of these by mutagens in the near future is diseases are expressed in infancy and in unlikely, minimizing exposure to early childhood and are chronic in mutagens is among the best available nature. As a result they cause a severe means to protect against further impact upon the affected individuals deterioration of the human gene pool. and their families in terms of physical This document describes the and mental suffering and economic procedures that the Environmental losses, and upon society in general, Protection Agency (EPA) will follow to which may often become responsible for evaluate the risk associated with the institutional care. Some examples of exposure of humans to chemical genetic diseases and syndromes mutagens. Previously, the Agency genetically based include Down's indicated its intent to develop syndrome and Klinefelter's syndrome, procedures in the "Criteria for cystic fibrosis, hemophilia, sickle cell Evaluating the mutagenicity of anemia, and achondroplastic dwarfism. chemicals" which describe the bu.sc Other commonly recognized diseases . concerns and need for such a doc ument which are likely to have a genetic basis (5). These procedures will ensure quality include hypercholesterolemia, rheumatic and consistency in the Agency's fever, hypertension, pyloric stenosis, scientific risk assessments for mutagenic glaucoma, allergies, and several types of effects. The necessity for a consistent mental retardation. These diseases are approach to evaluate the mutagenic risk only a few of the thousands which are from chemical substances arises horn associated with genetic errors (3). the authority conferred upon the Agency Mutations are largely recognized as by a number of statutes to regulate being deleterious to the organisms potential mutagens. These statutes receiving them. The adverse effects may include the Federal Insecticide, be manifested at the biochemical, Fungicide, and Rodenticide Act the cellular, and physiological levels of Toxic Substances Control Act, the Clean organization. Although mutations are Air Act the Federal Water Pollution the building blocks for further Control Act the Safe Drinking Water evolutionary change of species, it is Act and the Resource Conservation and believed that increases in the mutation Recovery Act rate above the spontaneous level will The mutagenicity risk assessments lead to an accumulation of deleterious prepared pursuant to these guidelines mutations in the human population (4). will be utilized within the requirements Since the existing incidence of human and constraints of the applicable genetic disease is already sizable, the statutes to arrive at regulatory decisions Agency wants to control exposures to concerning mutagenicity. The standards chemicals which may add to this of the applicable statutes and existing burden. regulations may dictate that additonal Because of the technical and considerations, e g., the economic and industrial expansion during the last two social benefits associated with use of decades, a large number of chemicals the chemical substance, will come into have been released into our play in reaching appropriate regulatory environment Some have been shown to decisions. have mutagenic activity in mammalian In order to ensure the quality and and submammaUan test systems, and consistency of the Agency's scientific thus have the potential to increase risk assessments^ EPA has created the genetic damage in the human Reproductive Effects Assessment Group population. Chemicals with mutagenic (REAG) in its Office of Research and activity in various test systems have Development This group will have the been found widely distributed among responsibility for carrying out an drugs, food additives, cosmetics, oversight function for the Agency's risk industrial compounds, pesticides, and assessment activities to ensure consumer products. As our knowledge of consistent application of mutagenicity genetics and disease etiology increases, risk assessment procedures, as well as it is reasonable to believe that we will the responsibility to conduct become aware of some chemically- mutagenicity risk assessments for induced human genetic effects. The program offices when deemed extent to which exposure to these necessary. The REAG will utilize, as appropriate, expert consultants and advisors from various Federal agencie academia, and the private sector to assist in reviewing mutagenicity risk assessments performed by the program offices or to assist REAG in performing risk analyses at the request of the program offices. The assessment of heritable mutagenic risk to humans involves a two-step process. First of all, the mutagenicity of the chemical must be determined, and secondly, evidence must be evaluated to determine if the chemical reaches or affects gonadal organs. Results from such an evaluation can be combined with expected human exposure information, when available, and the impact of the mutagenic risk for human populations can be estimated to * the extent possible. II. Concepts Relating to Heritable Mutagenic Risk For the purposes of these guidelines, a mutagen is defined as a chemical substance or mixture of substances that can induce alterations in the DNA of either somatic or germinal cells of organisms. The Agoncy is concerned with the risk associated with both germ cell mutations and somatic mutations. Mutations carried in germ cells can be inherited by future generations and contribute to genetic disease, whereas mutations occurring in somatic cells may be implicated in the etiology of several disease states, including cancer (6,7). These guidelines, however, only concern genetic damage as it relates to germ cell mutations. The position on the use of mutagenicity test results in the assessment of carcinogenic risk has been described in the Agency's Interim Cancer Assessment Procedures (6). The potential for mutagenic risk to germ cells can be identified on the basis of tests Involving either germ or somatic cells. In the case of somatic cell tests, however, the quantitation of mutagenic risk depends on evidence that the chemical or its metabolites reaches or affects a critical target (DNA) in germinal tissue. There are several mutagenic endpoints of concern to the Agency. These include point mutations (i.e., change in the base sequence of DNA) and structural and numerical chromosome aberrations. Structural aberrations include deficiencies, duplications, inversions, and translocations, whereas numerical aberrations refer to gains or losses of whole chromosomes (aneupi ;dy) or sets of chromosomes (hapk: polyploidy). The Agency's c :e of Pesticide Programs already had 000045930 74968 ________ Federal Register / Vol. 45, No. 221 / Thursday, November 13, 1960 / Notices published various testing standards for the detection of mutagenic effects (9). For some mutagenic mechanisms, it is conceivable that only one or a few molecules of the active compound may cause heritable changes in DNA. Mutagenic effects may also arise by mechanisms not directly related to chemical alterations of DNA. such as interference with DNA synthesis, DNA repair, or nuclear division processes. III.Rationale for Using Nonhuman Test Systems The virtual universality of DNA as the genetic material and of the genetic code provides a rationale for using various non-human test systems to predict the intrinsic mutagenicity of test chemicals. Additional support it provided by the observation that chemicals causing genetic effects in one species or test system frequently cause similar effects in other species or systems. Although cells of any species could theoretically be used to detect and predict genetic change in other species, certain test systems offer notable advantages, such as increased sensitivity: ease and Bpeed of conducting the tests: low cost; anatomical, histological, and/or metabolic similarities to humans; suitability for handling large numbers of test organisms; a large data base; and a basis for characterizing genetic events. Nonhuman test systems must be used because of the lack of suitable epidemiological data on germ cell mutations in humans. Clear epidemiological evidence for an increased mutation rate in humans due to exposure to a chemical substance is unavailable at this time. Presently only a very few of the estimated many thousands of genes in the human genome are useful as markers in determining the point mutation rates within human populations; there is a huge amount of genetic variability in the human population; and humans have a long generation time. Dominant and sexlinked recessive mutations can be detected in the first generation following treatment; however, autosomal recessive mutations and those affecting multifactorial traits largely go unnoticed because they are not recognized in the heterozygous state. Information on chromosomal aberrations induced in humans can be obtained with cytological techniques, but this information is limited. Thus, in most cases, although mutational changes occur in humans, they will be unobserved or unexpressed until future generations. IV.Risk Assessment Other tests have been designed to A.Testing Systems detect nondisjunction (unequal distribution of chromosomes during cell Assessing risks as a result of exposure division) in such diverse systems as the to chemical mutagens is a complex task mouse. Drosophila, fungi, and because of the diversity in chemical mammalian cells in culture. The present structure of mutagens and the various data base for these systems, however, is ways they can interfere with genetic limited at this time. Primary DNA processes. Therefore, in order to damage which provides information adequately assess the mutagenic bearing on the mutagenicity of a potential of a chemical, data from chemical can also be detected by a several test systems may be needed to variety of test systems, such as evaluate the ability of a chemical to unscheduled DNA repair synthesis in produce chromosomal alterations, point mammalian ceils, mitotic recombination mutations, and primary DNA damage in yeast and sister-chromatid exchange (manifested by DNA repair or in mammalian somatic and germ cells. recombinational events). There are many testing systems currently The test systems mentioned above are not necessarily the only test systems available which can contribute that will provide the best evidence of information about the mutagenic mutagenicity. These systems are potential of a test compound. enumerated merely to demonstrate the Test systems for detecting point breadth of the available techiques for mutations Include those in bacteria, assessing mutagenic potential, and to eukaryotic microorganisms, insects, and indicate the types of data which the mammalian somatic cells in culture, as Agency will consider in its evaluation of well as tests for detecting germinal mutagenic potential. Most systems mutations in intact mammals (e.g., the possess certain limitations which must mouse specific locus test). Positive be taken into account. The selection and results in a mouse specific locus test performance of appropriate tests for argue strongly that a chemical Is a evaluating the risks associated with potential human mutagen because the human exposure to any suspected test demonstrates the mutation occurs in mutagen will depend on sound scientific germinal cells and is transmitted to the judgment and experience, and may next generation. However, since the necessitate consultation with geneticists development of moose specific locus familiar with the sensitivity and data Is limited by the requirements for experimental design of the test system special strains of mice and a large in question. In view of the rapid number of test animals, it is not advances in test methodology, the expected that many chemicals will bo Agency expects that more relevant tools tested using this system. To obtain data for predicting human mutagenic on a large number of environmental potential will become available with pollutants, it will be necessary to rely on time. The Agency will closely monitor other tests to assess the risk of point- developments in mutagenicity mutations. Although prokaryotes, lower evaluation and will refine its risk eukaryotes, and mammalian cells in assessment scheme as better test culture do not have the ability to carry systems become available. out all types of metabolic conversions that occur in intact mammals, the B. Wcight-of-Evidence Approach addition of a metabolic activation The judgment as to whether a system derived from mammalian tissues chemical substance is likely to be a has made these systems a valuable tool potential human mutagen will be based for detecting mutagens. on a weight-of-evidence approach that For detecting chromosomal involves and considers the quality and aberrations, the following test systems adequacy of all the available data. have been employed: in vitro and in A positive response in the mouse vivo mammalian cytogenetic testa, specific locus test alone can provide insect tests for heritable chromosome strong evidence to regard a chemical as effects, dominant lethal teats in rodents, a potential human mutagen. As an the heritable translocation test in alternative to the mouse specific locus rodents, and the mouse sex chromosome test, positive responses in any two loss test The heritable translocation test different point mutation test systems in rodents is among the best available plus evidence for the presence of die testa for detecting heritable test substance and/or its metabolite* in chromosomal rearrangements' In mammalian gonadal organs also - mammals; the mouse X-chromosome provides strong evidence that a lots test is a value in detecting the compound is a potential human unequal distribution of chromosomal mutagen. Positive results in at least two material during gametogenesis. systems are desirable because of the 'i U)004S Federal Register / Vol. 45, No. 221 / Thursday, November 13, I960 / Notices 74987 possibility of obtaining false positive or apedes-specific positives. The heritable translocation test or the X chromosome loss test for chromosomal alterations in mice can provide equally strong evidence that a chemical is a potential human mutagen. Both tests detect events that are induced in treated mammals and transmitted to progeny where they are scored. In the absence of positive findings in these two test systems, positive residta in two in vivo somatic cell cytogenetic test systems or in an in vitro cytogenetic test system and an in vivo somatic cell cytogenetic test system, coupled with evidence for the presence of the test substance and/or its metabolites in mammalian gonadal organs, will provide strong evidence that a compound is a potential human mutagen. The teat systems described here may not detect aLI the genetic events that are of concern to humans. Furthermore, the sensitivity of some of these systems to detect mutations is not known and may be low for certain chemical classes. Nevertheless, positive responses in these tests currently provide the best experimental evidence that a chemical has the potential to produce genetic damage in people. If data suitable for applying the criteria ju9t described are not available, then the chemical substance under consideration will be assessed by examining all data that give insight to its mutagenic activity. The following factors will be considered: 1. Genetic endpoints (e.g., point mutations, chromosomal mutations) detected by the test systems. 2. Sensitivity and predictive value of the test systems for various classes of chemical compounds. 3. Number of different test systems used for detecting each genetic endpoint. 4. Consistency of the results obtained in different test systems and different species. 5. Whether the tests are conducted in accordance with appropriate test protocols agreed upon by experts in the field. 0. Evidence that a chemical reaches or affects the germinal tissue, as provided by Buch sources as data demonstrating the alkylation of DNA or other cellular macromolecules, unscheduled DNA synthesis, sister chromatid exchange, or chromosome aberrations, in germinal cells: and non-specific accumulation of radioactive label in the gonads following administration of the labeled chemical Other relevant evidence includes adverse gonadal effects following acute, subchronic or chronic toxicity testing; and adverse reproductive effects, such as decreased fertilization index, reduced sperm count, or abnormal sperm morphology. Data on these factors will be used to determine whether there is strong, substantial, or only suggestive evidence that a particular chemical may be potentially mutagenic to humans. Although definitive proof of non mutagenicity is not possible, it seems appropriate that a chemical could be classified operationally as a non mutagen if it gives a negative response in an adequate number of test systems that are together capable of detecting all genetic endpoints of concern, namely, point mutations, chromosomal effects, and primary DNA damage. Furthermore, if a chemical does not reach or affect gonadal organs, it can be considered not to cause heritable mutations. Stringent scientific criteria (e.g., adequate sample size, suitable experimental design, appropriate concentration range, proper controls, and adequate number of tests) should be required for acceptance of negative results to assure that the failure to detect genetic activity or the presence of the chemical in the gonadal tissue is not based on inadequacies of the test procedures. C. Quantitative Assessment ofResults The degree of risk can be estimated by combining the preceding qualitative evaluation for mutagenicity with the potential for human exposure. When there la a lack of appropriate mutagenicity data to make a quantitative estimate, risk can still be expressed in meaningful descriptive terms. To do this, the strength of evidence that the agent possesses intrinsic mutagenic activity, that it reaches or affects gonadal organs, and the extent and pattern of human exposure to the chemical, must be examined. From these elements a judgment as to the degree of human risk may be derived. When appropriate mutagenicity data are available for making a quantitative estimate of genetic risk to humans, two major approaches are available. One approach uses only experimental data on germinal alterations induced in intact mammals. Test systems providing Buch data are the heritable translocation, X- chromoaome loss, and specific locus tests. These tests are complete in that they directly measure genetic damage in germ cells which Is observed in a subsequent generation. In this approach, information on the level of human exposure is used with experimental data on induced mutation frequency, usually obtained at much higher exposure levels. An estimate of human risk is obtained by extra polating the induced mutation frequency downward to the approximate level of anticipated human exposure. With point mutational effects, there is a strong theoretical basis for the use of the linear or no-threshold models for this extrapolation (10,11,12). For certain chromosomal alterations, the biological mechanisms are generally thought to fit a multiple-hit model. Other mathematical models for extrapolation should, therefore, be considered when the dose-response data are able to fit an appropriate model. Linear extrapolation of the experimental data on translocations, for example, are likely to overestimate the risks present at lower levels of exposure and a model other than the one-hit model should be considered. The other experimental approach for assessing genetic risk uses biochemical data from intact mammals and mutagenicity data from Validated test systems (13,14,15). The intact mamma) is used primarily for relating the exposure level for a chemical to germ cell dose. This involves relating the level of mutagen-DNA interactions in germ cellB to the specific exposure level by an appropriate route of administration. This information is then used with results obtained from mutagenicity test systems in which the relationship between the induction of mutations and interactions with DNA can be made. Using mutagenDNA interactions as the common denominator, a relationship can be constructed between exposure and the induced mutation frequency. In some cases, measurements of DNA binding induced by a particular chemical agent can be determined at levels of exposures which may affect human populations, and potential human risk can be determined without the extrapolation of the data to lower levels. Such results would not require a high to low exposure level extrapolation to determine potential human risk. In those instances where the lowest experimental exposure level is greatly above those levels to which humans are exposed, it will be assumed that DNA binding is directly proportional to the exposure level unless there are compelling reasons to believe otherwise. For some mutagenic events, DNA may not necessarily be the critical target. Interaction of chemicals with other macromolecules, such as tubulin which la involved in the separation of chromosomes during nuclear division, can lead to chromosomal nondisjunction. At present the means are not available to make strictly quantitative assessments for these types of mutagenic mechanisms. Ongoing research should provide the means to 74988 Federal Register / Vol. 45, No. 221 / Thursday, November 13, 1960 / Notices make future quantitative risk assessments for mutagens acting through these mechanisms. In performing mutagenicity risk assessments, it is important to account for the sensitivity of the tests in detecting specific mutagenic endpoints. For example, although chemical substances which interact with ONA are likely to cause both point and chromosomal mutations, it is expected that point mutations may be relatively more frequent than chromosomal mutations at lower exposure levels. The former event can be initiated by a single interaction with DNA, whereas the iatter may involve more than one interaction. Therefore, when assessing the mutagenic risk associated with low human exposures to the chemical, the point mutation data would generally be the more sensitive and appropriate information source. Any risk assessment should clearly delineate the strengths and weakness of assumptions made, the uncertainties in the methodology, and the rationale used in reaching the conclusion, e.g., similar or different routes of exposure, metabolic difference between humans and test animals. The results should be expressed in terms of the excess of genetic disease per year or per lifetime, or the fractional increase in the assumed background spontaneous mutation rate of humans, or the radiation equivalency. V(. References 1 . Flamm. W. G. 1977. Approaches to determining the mutagenic properties of chemicals: risk to future generations, j. Environ. Path, and Tox. 1:301-352. 2 . United Nations Scientific Committee on the Effects of Atomic Radiation. 1977. Sources &nd effects of ionizing radiation. Report to the General Assembly. 32nd Session. Supplement No. 40 (A/32/40]. United Nations. New York. 3. McKusick. V. A. 1970. Mendelian inheritance in man: catalog of autosmal dominant, autosomal recessive, and X-linked phenotypes. 5th ed. Hie Johns Hopkins University Press. Baltimore. 4. National Academy of Sciences, National Research Council. 1972. The effects on populations of exposure of low levels of ionizing radiation. Report of the Advisory Committee on the biological effects of ionizing radiation. Washington. D.C 639 pp. 5. U.S. Environmental Protection Agency 1978. Proposedguidelines for registering pesticides in the U.S* Hazard evaluation: humans and domestic animals. Federal Register 43:37400-37403. August 22. 8. Burdette. W. J. 1955. The significance of mutation in relation to the origin of tumors: A review. Cancer Res. IS: 201-228. 7. McCann, J., and B. N. Ames. 1977. The Salmonella!microsome mutagenicity test: predictive value for animal carcinogenicity. In: Orignins of Human Cancer, Book C. Edited by H. H. Hiatt J. D. Watson, and J. A. Winsten. Cold Spring Harbor Conferences on Cell Proliferation. 8. U.S, Environmental Protection Agency. 1978. Interim procedures and guidelines for health risk and economic Impact assessments of suspected carcinogens. Federal Register 41: 21402-21405, May 25. FOR FURTHER INFORMATION CONTACT! Libby Welch, Registration Division (TS- 767). Office of Pesticide Programs, Environmental Protection Agency, Rm. E-124, 401M St., SW,, Washington, D.C. 20460, (202-426-0223). 9. U S. Environmental Protection Agency 1978. Proposed guidelines for registering pesticides in the U S.. Hazard evaluation: human and domestic animals. Federal Register 43:37388-37394. August 22. 10. Ehrenberg, L. 1979. Risk assessment of ethylene oxide and ether compounds, pp. 159-191. In: Banbury report. L Assessing SUPPLEMENTARY INFORMATION: The Applicant anticipates that an emergency situation will develop with respect to cabbage loopers on cabbage in upstate counties of New York. The Applicant contends that if the cool weather setB in during the last 35 days of cabbage chemical mutagens, the risk to humans. Edited by V. K. McEIhcny and S. Abrahamson. Cold Spring Harbor Laboratory, Cold Spring Harbor, New York. 11. Muller, H f. 1954. The manner of production of mutations by radiation, pp. 351-473. In: Radiation Biology Vol. 1. Edited growth, the cabbage looper will not be controllable. The Applicant claims that use of the pesticides registered for control of the cabbage looper is not practicable because: 1. The pesticide Phosdrin Is not very by A. Hollaender. McCraw HilL New York. effective against the pest and its 12. Auerbach. C 1976. Mutation research: residual action is short. Problems, results and perspectives. Chapman end Hall, London, pp. 73-67. 13. Lee. W. R. 1978. Dosimetry of chemical mutagens in eukaryote garm cells, pp. 177202. In: Chemical mutagens, VoL S. Edited by Alexander HolLendcr and Fredrick J. deScrres, Plenum Publishing Corporation, 2. The pesticide Diazinon has not been effective in New York for many years. 3. Methomyl and Bacillus thuringiensis do not control the cabbage looper when temperatures are low. 4. While Monitor generally controls New York. the pest, it may not be used within 35 14. Aaron. C. S,, A. A. Van Zeeland. G. R. Mohn, A. T. Natarajao, A. G. Knapp. A. D. Tates, and B. N. Ghukman. 1980. Molecular dosimetry of the chemical mutagen ethyl methanesulfonate. Quantitative comparison of mutation induction in coli, V-79 Chinese hamster cells, L5173Y mouse lymphoma cells days of harvest. This 35-day preharvest interval is a critical period for cabbage due to the unusually high infestation of the cabbage looper. The Applicant estimates that the cabbage industry in New York could and some cytological results in vivo and in lose up to $12 million without adequate vitro. Mutat. Res. 69:201-218. control. 15. Aaron, G S. and W. R. Lee. 1978. Molecular dosimetry of the mutagen ethyl methanesulfonate in Drosophila melanogaster spermatozoa: linear relation of DNA alkylation per sperm cell (dose) to sex linked recessive letbals. Mutat Res. 49:27-44. ,Dated: November 4 1990. Douglas M. Cootie, Administrator. (FR Doc. 80-3495# Piled Ml) BILLING CODE 6590-93-41 The Applicant proposes to use fenvalerate at a rate of 0.1 to 0.2 pounds active ingredient (a.i.) per acre on up to 12,000 acres of cabbage. More than 50 percent of the fields checked In a county would have to be Infested with cabbage loopers in numbers greater than one to two loopers per plant as determined by research on Cooperative Extension personnel. Application would be made only when anticipated average daily temperature during the spray period is [OPP-160523; PHHFRL 1668-2] below 8s F during the day and/or 55-60* - New York; Issuance of Specific Exemption for Fenvalerate on Cabbage F at night. EPA has determined that residues of fenvalerate in or cabbage should not exceed 2 parts per million (ppm) from agency: Environmental Protection Agency (EPA). the proposed use. EPA has judged this level to be adequate to protect the action: Notice. public health. No unreasonable hazard to the environment is anticipated from summary: EPA has granted a specific this program. Since fenvalerate is highly exemption to the New York Department toxic to aquatic vertebrates and of Environmental Protection (hereinafter referred to as the "Applicant") to use fenvalerate (Pydrin) on 12,000 acres of cabbage in New York to control the cabbage looper. The specific exemption is issued under the Federal Insecticide, Fungicide, and Rodenticide Act. invertebrates and to bees, appropriate conditions to protect them having been imposed. After reviewing the application and other available information. EPA has determined that the criteria for an exemption have been met Accordingly, date: The specific exemption expires on the Applicant has been granted a November 1.198a specific exemption to use the pesticide fifCf/VED FEB 0 6 1981 News xtejnvt erwci c* rug nijccwt COlmci. ox EnywOmmcxtal Ouautv ra iacnaow x-*t nw. wumatok sc non CONTACT: Charles Osolin Office of Public Information 202/395-5770 HOLD FOR RELEASE Monday, January 19, 1931 6:00 PM E.5.T. WASHINGTON -- Despite growing evidence linking certain chemicals with reproductive impairment in humans, few of the 55,000 chemical substances and mixtures now in commercial production have been tested for their effects on reproduction, according to a report released today by the President's Council on Environmental Quality (CEQ). The report, Chemical Hazards to Human Reproduction, was prepared for CFQ by Clement Associates, Inc.., a scientific regulatory consulting firm in Washington. The report identified a large number of factors that affect reproductive health, including- drugs, chemicals, cigarettes, and alcoholic beverages. According to Dr. Robert Harris, a member of the Council, "reproductive impairments, including the inability to conceive, miscarriages, premature births, low birth weight, birth defects and perinatal mortality are both frequent and widespread in the U.S. population, affecting millions of couples at one time or another. "This report," Harris said, "clearly -documents that environmental factors, such as nutrition, diet, stress, infections, and exposure to both natural and manmade chemicals are substantial contributors to certain types of reproductive impairment." The report noted that although there is growing evidence linking chemical exposures in the workplace with reproductive failure, few efforts have been made to determine the significance of low-level chronic exposures to these chemicals by the public at large. Cigarettes and alcohol were the only agents reported to have shown substantial effects on the general population. From a preliminary analysis of 21 chemicals that have been shown to represent a reproductive hazard to humans, the report concluded that laboratory studies on experimental animals correlate with the human effects from exposure to these chemicals. With one exception, humans appeared to be somewhat more sensitive to these chemicals than the most susceptible animal species tested. -Z- Despite the availability of animal tests for assessing the potential reproductive hazards of chemicals, the report cautioned that there is no suitable pre-screening test for detrrmining which among the thousands of chemicals to which humans are exposed are most in need of further animal testing to determine their reproductive hazard to humans. In contrast, a number of pre-screening tests are now in widespread use for determining the cancer-causing potential of chemicals before they are introduced to the marketplace. Although the federal government has broad authority to regulate chemicals that pose reproductive hazards, the report concluded that regulatory agencies have placed relatively little emphasis on such hazards in their recent regulatory actions. "This report argues both for greater attention to potential adverse reproductive effects in regulating chemicals," Harris said* "and for caution in developing such regulatory actions until better methods for risk estimation are developed." The report also said current scientific knowledge of chemical hazards to reproduction is about where knowledge of cancer-causing chemicals was in the 1960s. "If scientific knowledge of reproductive hazards were developed in an orderly manner," the report said* "there would be an opportunity to avoid some of the controversies that have been raised by regulation of chemical carcinogens." # * MOTE: Copies of Chemical Hazards to Human Reproduction are available fronT^he Council on invironmencal^Quality* 722 Jackson Place, N.W., Washington, D.C. 20006. Please enclose a self-addressed mailing label and allow six weeks for delivery. BI O00045935 Editor: Mary P. Kilcoyna February 13, 198Q FEDERAL LEVEL OCCUPATIONAL SAFETY AND HEALTH Equal Employment Opportunity Commission Interpretive Guidelines on Employment Discrimination & Reproductive Hazards RECEIVED FEB 2 0 1980 The Equal Employment Opportunity Commission has proposed guidelines (Federal Register, February 1, 198Q, pp.7514-7, attached) setting forth for the first time interpretations of the relationship between employment discrimination and the application of employer/contracter policies, practices and plans regarding reproductive hazards. As proposed, the guidelines would regard personnel policies and prac tices which result in blanket exclusions of women as per se violations of both Title VII (of Civil Rights Act) and Execuitve Order No.11246, unless policies were justified by employers through research which studied the effect the workplace hazards have on men. The proposed guidelines call "discriminatory" those "policies, practices or plans designed to protect employees from reproductive hazards which, by their terms, exclude applicants or employees from employment oppor tunities on the basis of sex". However, neutral policies which protect all employees from reproductive hazards are permitted if they do not have an actual "adverse impact" on only one sex. The guidelines would require employers that currently have exclusion of women policies in existence to begin research to determine if men are affected by the hazardous substance. The research must be started with in six months, and completed within two years, and may be conducted with OSHA or trade association assistance. ,,,, RL k? 0 (). However, if an employer has already determined by "reputable scientific evidence" that men are not affected by the hazardous substance, but women are, the exclusionary policy may be continued, provided it is nar rowly applied and alternative methods for placing female employees are ex** plored. The guidelines would not permit "overboard policies", such as those which exclude all fertile women because of concern for possible harm to a fetus. (continued) THE SOAP AND DETERGENT ASSOCIATION 475 Park Avenue South, New York, N.Y. 10016 (212)725-1262 G-41 -2- February 13, 1980 The guidelines would permit "emergency temporary exclusion" in certain situations where the employer has reputable scientific evidence of workplace reproductive harm to one sex only, without such evidence of harm to the other sex- However, such temporary exclusions would have to be followed by research and investigation into suitable alternatives. Comments are being solicited on the following: (1) the nature and scope of exclusions from employment opportunities based on reproductive hazards in the workplace, C2) the scientific evidence justifying or refuting the exclusion of sex-based classes, (3) the provisions in the guidelines which allow the temporary emergency use of policies based on re search on only one sex-based class, (4) the requirements for balanced research, and (5) the problem of tort or other liability of the em ployer/contractor because of compliance with pro posed guidelines. Such comments should be submitted by June 2, 1980 to: Executive Secretariat Equal Employment Opportunity Commission 2401 E Street, NW Washington, D.C, 20506 7514 Federal Register / Vol. 45, No. 23 / Friday, February 1, 1980^/ Proposed Rules EC'-AL Er.:?LOYW2rJT OPPORTUNITY cr,....;:ss:0N 20 CFR Part 1603 L-iPAnTttSMT OF LABOR r;;:co of Federal Contract Compliance i . -gams :i crn Parteo-20 IrrirrYrctivs Guldollnss on ;. ay~.cnt Recrimination and .stivo Maccrcla t~. Equal Employment Opportunity Co:r.:nission and Department of Labor. 'T'.^y. Proposed rulemaking. SL':.:'.*r..T/: This document sets forth for the first time proposed interpretations of the relationship between employment discrimination and the application of rr.ployer/contractor policies, practices v i plans regarding reproductive hazards. The guidelines are intended to establish a consistent approach to crforcement of the legal responsibilities ereated under Title VII of the Civil L. -hrs Act of 1CG4, as amended (Title V f and Executive Order No. 1124G, as a " : .ded (5.0.11216). They ere : vended to provide guidance to the '-.'p'oyer/contractor in meeting its i sr sensibilities under Title VII and E.O. 11243 to ensure non-discrimination and to orovido equal employment opportunity. These guidelines and the objectives of Title VII and E.0.11240 are premised on the assumption that laws prohibiting discrimination in unployment are consistent with those aws designed to assure a workplaca i.cri cf conditions that threaten the health or safety of employees. It is -cpTv.zcd that the concerns of the amercement agencies with respect to : n-discrimnation in employment are, ..owever, distinct from the concerns of agencies responsible for health and safety regulation; these guidelines preserve those distinctions. C.-YT": Written comments should be received by June 2,1980. . Written comments may be ur-'iiussed to: Executive Secretariat, Equal Employment Opportunity Commission, 2401 E Street, NW., Washington. D.C. 20506. All public comments may be reviewed from 9:30 a.m. to 4:20 p.m., Monday through Friday, at Library (Room 2303), Equal Employment Opportunity Commission, -01 2 Street. NW., Washington, D.C. rco pjnTHSi ttircnr.tAnoH contact: Frederick D. Dorsey, Director, Office of Policy Implementation. Equal whether such practices conform with Employment Opportunity Commission, federal ajiii dajorimmaiiiai I,..,a. l.i a 2401 E Street, NW., Washington, D.C. 1 May :U. jy/0, leth c fi.au th.s Ih-j,. Uirmut 20500, 202-034-7060, or James D, Henry, rf JLahor'ii A>; ii.t cu F.x i. for Associate Solicitor, Office of tho Occupational Safety i'n 1. Uh I ..In Solicitor, Department of Labor, 2C0 Bingham, to ail major A.u.ui .u Constitution Avenue, NW., Washington, corporate medical diicetiuu, ( D.C. 20210, 202-523-6235. expressed its concern jv^.xuiii.'t SUPPLCKZHTARY IKrCRMATtCJK An overview of the proposed lixterpietivo Guidelines on Employment Discrimination and Reproductive Hazards. Introduction employment practices v.lxu h .L r;v oppuiutniiie-j to any da.,s id ..iMkora on thj basis of safety and Jvi.Uh i h.-;.J ^ guiJcIiiiej r.pc.'ificulty nd.lw riiuro eituiitiOiis involving aUe^-.uious of sex discrimination. EVfJC and OFCCP have determined These guidelines bring together the collective efforts and expertise of several federal agencies. Those efforto that policy guidance must be ism.u-J boctnue, iu the absence of dua.iLd fedt.-al policy on this ismiu, ibsio is were necessitated by dunces presented to the Equal Employ mom luruty Commission (EEOC) and to the CliU.3 of Federal Contract Compliance Plvjramo (OFCCP) (the enforcement a^cnAas) wide., urea i confusion :iunj.ri;> c-u.ploycrs, contrartoiu and ihc public us iu v.Jut is requixud. Guidelines prn.idc iha most structureJ moihed f: r uvui.ut mealing policy to the public and idea fur L-..taring alleging employment J.isuimiiwiion in workplaces containing su-.b^ianc-s end conditions hazardous to reprcJuc'Mve health. The issues aJdrc. rod by theca guidelines are especially imou.tant public pn.:i_\puticr nn.t hoa: fu.m oil i d afi,cc:ed],aiiu.j. Coo.o.att-.'ri v.Lh ihc deLre fur c: -torch o commax.is, .'vi notice cl . ...e. guidelines p.o ..dc-a fern iaj J:, / because employment puUe.u-j, n.uuiiccn and plantj iclming to ieprcJuu;U.o hazards cun ha to the effect of denying employment opportunities to CCm.i.jut uried. The u.-.c.cement cgenciec v v especU.i'y !-t;evs:stj ir, u^i.c.u..g COiruuCii.s cn xhe lOlle-.. .,-j: individuals. (1) the na.urc end Eccpe ct e .elusions from In the course of its deliberations, EEOC, OFCCP and the Occupational Safety and Health Administration (OSHA) have had extensive discussions internally and with Other federal agencies. The proposed guide-lines emi lo>uirj.i opiex;c i.c.u,, b,--. J u.i reptuuUci'.vo hczs.Ja ;n ch.u v,^.: ' -il (2) the sc eu.-uc eviJti.wJ i r rtfe: ;:j .he r\. 'usion ci cc < t u. -.l u'cr'sc", (3) the p.cv .-.ic.'J in the tjca't-iiiu j :!i tiMo./ the temporary t'lr.er.j.xy use oiicies bastvl on ceaeuiu'i on cify e..2 sex- clearly define the basic role of Cu'HA a3 S&Ol1 ulil.lS, one of consultation and coordination (4) the ie,]i'.uoments for balanced resea rch, with EEOC and OFCCP, pavtku.lu.ly with reference to scientific data. Sections 2(d)(2), 2(d)(0), 2(b)(3), 3(b)(1), and 3(c) of d.u proposed guiiuliueJ refer to tho consultation and cooidia..uon that will bo carried out, in part, through a Letter of Agreement nmung OL. LA, EEOC and OFCCP. It was also during this process that EEOC and OFCCP became aware of the increasing number of employes and contractors who are initiating jn-huies excluding all women of childbearing capacity from certain jobs because of exposure to hazardous aubstanuwS or conditions. Preliminary evidence indicates that as many as 20 million jobs may involve exposure in the workplace end (5) the problem of tort or other liability of the cnij.tOi ci/LVutmotcr bes.u-.ro of comi-lianuo v.iih proposud guu!ullr.L'3. The enforcement agcneiea do .*ot, at thin poirxt, seo n need i`o. a v analysis. C Munanto on this ,.ra requested. Ihe exiro.cc'x'ncj.t iU'cncics espaLi^lly note lh.ri the pru;,J gui-JDlir.ua do not adumpt to i,;- .'e.r.ent or eat'o.co federal pultLies .1 -o health and safety. Thi..;u ^..uL offina ubo {.i al of Tale Yri t.x.d L.O. 112-TJ to assare equ^Utx cf cxa. 1 ^mar.t opporiuiiity. The ta^k of a^.a.a v.-orkpdr.cu free of co...Utica., that thvcatuit th.,- health or s.-icty .1 employee.j fu oairisi v.ah che J.e.nl to alleged reproductive hazards. Chemicals and physical agents which egfla.-UJ S,xatiiiCu!lj gi.. ...a di^t respOxi;ab:l'.;y. have been alleged to pose such hazards include leod, polyvinyl chloride, radiation, estrogen, anesthetic gases, EKPL/TN/iTOfl!f NOTE Analysis and organic solvents. In response to A numher of employers and such exclusionary practices the CEOC, contractors have policies uf nut hiring on April 21,1970, issued a policy women of childbearing cap^-lty for ich:; statement indicating its concern about in which there is expoua lti to uile-jcJ ta to hAL 00004Ui?A8 Fedr :al Register f Vol. 45, No. 23 / Friday, February 1, 1960 / Proposed Rules reproductive hazards and have terminated or transferred women to lower paying jobs .based on such policies. Employers and contractors in establishing such practices often show a lack cf ccncemfor similar effects on men, Some employers and contractors have attempted to justify these policies on the basis of potential harm occurring to an unborn child through exposure of the mother. These policies have been developed Without apparent regard to w: -j'.i.or exposure of lha father can result in kaitn to the unborn child. Title VII and E.0.112x9 require that the enforcement agencies closely sr-rutinize the exclusion of a sex-based class from consideration for employment. Section 2(a) reaffirms the unlawfulness of exclusions which by their terms are based on membership in a sex-based class. Such exclusions are per so violations of Title VII and E.O. 112-13, because the exclusions are expressed or implemented in terms of membership in a class protected by Title VII and E.O. 11210. Section 2(b) states that an employer/ contractor's conduct which disparately treats members of a sex-based class raises a presumption of a violation of Title VH and E.O. 11219. Where such a presumption ia raised, an employer/ contractor will be given an opportunity to articulate a legitimate, non- discnminatL.'y reason for the policy or practice. The enforcement agencies will then determine whether that reason is in fact a pretext for employment discrimination. Section 2(c) is based upon the traditional concept cf adverts impact. A facially neutral pciicy which has un adverts i/nva-i upon a specific cex-bcc:d class ts an unlawful ?n:T~vmer.tcs t "ices it is truly y f; e., <: :j a c: -.text ftr c. r-.i.cs'ion) :c\ V ;uci:f:ed by ths r!v.x.oyer/contrsctcr ; it is important to rote that, as a result of the Pregnancy Discrimination Act, Pub. 1. 93-353. C2 Stat. 2037 (1978), wen. -n affected by pregnancy, childbirth or related medical conditions constitute a protected cla33 under Title VII. AH such women must be treated the same for employment-related purposes as other persons not so affected but similar in their ability or inability to work. For example, where an employer/ contractor seeks to determine the 1 McDonnell Douglas Corp. v. Green. 411 U.S. 792 lUt/Jt. ` Griggs v. Duke Power Company. 401 U.S. 424 11971]: Robinson v. Lorillard Co.. 44 F. 2d 791 (-4th. Cir. 1971 ]: Albemarle Paper Company v. Moody, 422 l' S. 407 {1075}; Uniform Casdohnes on Employee Sole, lion Procedures (1978), 41 CFR Part 60-3. hazardous reproductive effects on pregnant women from their exposure to a certain substance or condition, the employer/contractor must also determine the effects on males and non* pregnant females from their exposure. If the hazard is known to affect the fetus through either parent, an exclusionary policy directed only at women would bo unlawful under Title Vll and E.O. 31249. Further, if the hazard Is shown by reputable scientific evidence to uffcct the fetus through women only, the class excluded must be limited to pregnant women and not all women of childbearing capacity. Whether expressed in a policy or not, the employer/contractor's conduct will be examined by the enforcement agencies to determine whether the conduct is non-discriminatory or justified, as set out in section 2(d). In making this determination, at least the following factors, if relevant, will bo considered. Whether: 1. the reproductive hazards policy haa been applied consistently to both sexes: 2. the employer/contractor has complied with applicable occupational safety and health laws: 3. the employer/contractor has investigated the effects cf all suieniificaHy recognized reproductive hazards in its vvoikpluces on those adversely affected and those not similarly affected: 4. the hazard ia significantly greater for or confined to the excluded group: 5. the employer/contractor has u pattern of discrimination against the excluded group; 0. the policy is narrowly tailored to the type of hazard po3od; 7. with respect to any reproductive hazard for which the employ ci /contractor takes action resulting m exclusion of a sex-based class, there is no evidence that the hazard poses a significant health risk to body systems other than the reproduciive system for the class not excluded; 0. the cmpioyer/ccmrcctor has investigated elterr.atives to exclusion (in this record it should be noted that the employer/ contractor who ia not in compliance v.ith occupational safety and health laws relating to the hazardous substance or condition wiil bo presumed to not have considered all available alternatives- This includes section S(u)llJ of the Occupational Safety and Health Act, which requires an employer covered by the Act to furnish to each of its employees employment and a place of employment which ore free from recognized hazards that are causing or likely to cause death or serious physical harm.); 9. the cmployer/contraclor ia monitoring scientific developments. When justifying an exclusion or rebutting a presumption, the employer/ contractor must demonstrate that the * results of the research on which it relies are applicable to the circumstances in the employer/contractor's workplace where the substance is us.ui i. the condition exists. This in. factors such ts the h'vel ,1i--i < manner of exposure, and the characteristics (including sc:. . subjects studied--all campus, i : . ... substances use in the paitir .1 : employer's workplace and the composition of the workfou i ; workpluce. The enforcement agenci.:... ,.-v i..-* that there may bo situations . employei/contractor haa ran scientific evidence of reprede .-.i:; to one sex-based class, only, evidence regarding the otha: L. .... class. These guidelines woul-J . ; prohibit a temporary policy i- y the endangered sex-based <. V .. provided that the policy (a| i tailored to those individuals `t.l u. harm is indicated, (b) reflc.3 - consideration ahd adoption -a ..- .... alternatives, and (c) provide .; i completion of research ontlm - .. based class. This laut requirement, in ctrc V:i 1 requires the completion of investigation neceusary to d. . effects, if any, of a hazard; , or condition on the claso m. i..i.,. affected by the employer''ccnt.Uwi.. policy. Fl r example, if scientific evidence has beer: compiled <-r> the haza.Jouti reproductive elk substunce on women, apprcia;...-.: studies miist bo dene to Jeic i.. .*; reproductive hazards exist tor . ;. .t is the position of the enforce. _ os that the time provided in sec';;.. .) is sufficient for employer/coii. e,.: in investigate, initiate and/or com an/ scientific research regarding the n.u nual effects of a particular repr-./ .icu. hazard on both sexc3. Jn cor. '. *x .i with OSH..A, the National Ir^i-.u..' Occ'cpadcna! Safety end J ''d the National Institute of Enivrct Health Safety, it was dLieni. : . . such resaaich codJ be? porfoiin one year or less. Should jiivliiu: : research bo needed to dev Jen ti.. appropriate protocol (method "*. exposure, dosage, etr.) a fa.. 1 1 mrud months might be necessary. .-.I :e period was specified as the 'a . t feasible time not to exceed .......... a. to allow for unforeseeable* dc:.._ .. d:e research process. Sections 3(bKl) and 3(b);Vj intended to acknowledge ilk- ; . ins a small employer/contractor in.,in 1 . *. e in completing the requisite icjc.... individually. Most of the ce . pi and information received h ; t. n.-nt agencies to date invoke La. . ; ;,vis and contructors. The enfi-.ect. - .: agencies are interested .7510 Fc: 27zl Recister / Vo!. 45, Mo. 23 / Friday, February 1, 1980 / Proposed Rules comments on the er.'rent cf tha'use of hazardous subatancre end conditions in small employer/cOii.ructor's workplaces, on the uur.ilrer of, r.'cclcjioiiury pOi:;:.}, ij.actices and pUres due u 1,^.1 catha burdens that tvculd bo placed on smoU employers ar.d ccntraclors from , compliance with tiio rccaarch requirements of sections 3(b) and 3(b)(2). Should a email employer/ contractor be unable to initiate and complete the required rerearcu individually, tho guidelines provide two alternatives. Tho email employer/ contractor can, and in fact i3 encouraged, to conduct the research with one or more oilier employer/ contractors end/or through a trade association. The requirements of sections 3(b)(2) and 3(c) will apply to such rescal'd!. The email employer/ contractor can also request, wuhin the time period required by seeder. 3(b), OSHA to perform the necessary research. OSHA is prepared to act promptly to such requests for assistance. * In determining whetiic? an employer has the necessary capacity, the enforcement agencies will consider such factors as whether the employer has the facilities and personnel to perform the scientific research required; whether the employer in the course of its business performs scientific research similar to that required; whether the employer h3S the resource", either by itseif or jointly with other employers, to sponsor or contract out tor the necessary research; and whe dier tns employer routinely sponsors or ccntraAs out for scientific research. An approved request will satisfy tha rsrj. L smenta of section 3(b;:2l. Section 3 w: j be applicable only -p during the nerisd v.v_.io an empleyar/contrcctcr is completing the rser o~r reee_..eh (o:,%er individually or s'vJy sr "~H\M M eempistir.j tho siv for :t. /'_'.ss 'l:st 'hue ai! employe :nt policies related to reproductive Lucords must be in full comoliar.ee yyi'.h iho proposed guidelines. T'.vo final points should be noted. First, the bena f.'d: occupational, qualification exception does not apply to the situations coyered by tliese guidelines. Taut narrow exception pertains only to situations whero all or substantially ad of a protected class io unable to perform the duties of tire job in question. Such cannot be the case in the reproductive hazards setting, where exclusions are based on the premise of danger to the employee or fetus and not on the ability to perform. Finally, these guidelines do not must be justified in accordance with preclude an employer/contractor from relevant legal principles.8 temporarily removing employees of both (d) In determining whether an coxes from work areas with employer/contractoris conduct reproductive hazards if such employees adversely affecting employment declare to the employer/contractor on opportunities is non-discriniinatory or intention to procreate end voluntarily Justified pursuant to these guidelines, request such exclusion. In advising the following factors are among those employees of the potential risks posed by particular hazards, the employer/ contractor shall do so on a nondiscriminatory basis. which may be considered by the Equal Employment Opportunity Commission and the Office of Federal Contract Compliance Programs (hereinafter "the Signed at Washington. D.C. this 29th day of enforcement agencies"}, where relevant: January, 980. (1) Whether the reproductive hazards Ray Marshall, Secretary ofLabor. Eleoscr I .Aimes Norton, ChairFor the Commission. Donald E&biurg, policy, practice or plait is applied consistently to employees and applicants of both sexes, and to all scientifically recognized reproductive hazards in each of the employer/ contractor's workplaces; Assistant Secretary, Employment Standards Administration. (2) Whether information obtained from the Occupational Safety and Weldon J. Rougeau, Health Administration (OSHA) or other Director. OFCCP. It is contemplated that these guidelines, if adopted, would become a portion of 41 CFR Part 60-20 and would be added to 29 CFR Chapter XIV as a new Part 1603. federal, state or local authorities shows that the employer/contractor has complied with applicable occupational safety and health laws; (3) Whether the employer/contractor has investigated tho effects of all scientifically recognized reproductive Interpretive Guidelines on Employment . hazards present in its workplaces not Discrimination and Reproductive only on those classes adversely affected Hazards by the policy, practice or plan, but also Sec. 1. General requirements. An employer/contractor whose work environment involves employee exposure to reproductive hazards shall not discriminate on the basis of sex (including pregnancy or childbearing capacity1)*in hiring, work assignment, or other conditions of employment See. 2. Nondiscriminatorypolicy to protect employees from reproductive hazards, (a) An employer/contractor may not have policies practices or plans designed to protect employees from reproductive hazards which, by their terms, exclude applicants or employees from employment opportunities on the basi3 oi ssx. Such policies aro discrimbiatory on their face. (b) An employer/contractor may not dispareiely treat individual applicants or employees on the basis of sex. Such treatment constitutes cn apparent violation of Title VII and Executive Order Mo. 11240, as amended (Executive Order Mo. 11248), (c) An employer/contractor may establish a neutral policy, practice or plan to protect all its employees from reproductive hazards. However, a facially neutral policy, practice or plan which has an adverse impact on one sex on those relevant classes not adversely affected, and has relied upon reputable scientific evidence in developing its policy, practice or plan: (4) Whether, with respect to any hazard for which the employer/ contractor has an exclusionary policy, practice or plan, the hazard is significantly greater for or confined to the class excluded than for the class not excluded: (5) Whether, prior to the institution of the reproductive hazard policy, practice or plan, the employer/contractor had provided the adversely affected sex with equal employment opportunities: (6} Whether tho class adversely effected by the policy, practico or plan In question is narrowly tailored to the type of hazard posed (overbroad policies, such es those which exclude all fertile women because of concern for possible harm to a fetus, are impermissible); (7} Whether, with respect to any reproductive hazard for which tho employer/contractor takes action resulting in exclusion of a sex-based class, there is no evidence that tho hazard poses a significant health risk to body systems other than the 1 Pregnancy Discrimination Act. Pub L 95-855,92 Stat 2070 (1078). See Sec. 701 k of Title VU. * Griggs v. Duke Pvwer Company, 4M U.S. 424 (1971); see Uniform Guidelines on Employee Selection Procedures (1970). 41 CFR Fart 60-3. 40 00 4 Fcderrl Register / Vol. 45, No. 23 / Friday, February 1, 1980 / Proposed Rules 7517 reproductive system for the class not excluded; (8) Whether the employer/contractor has investigated alternatives (o the exclusion of adversely affected employees from the workplace and, where feasible, adopted alterriative ^ means of protecting the affected employees from the reproductive hazard In question: (i) Examples of such alternatives may include reduction of the level of exposure to the hazard so that the reproductive risk is minimized or eliminated; use of respirators or other protective devices to minimize exposure; product substitution; and transfer of affected employees, without loss of pay or other employment benefits and with continued accrual of seniority, to an area of the workplace in which exposure to the reproductive hazard is minimal or nonexistent; (ii) In selecting from a group of alternatives, the employer/contractor shall select the alternative which has the least adverse jmpact upon the affected employees- In addition, whenever an employer/contractor is shown an alternative to the exclusionary policy, practice, or plan, or an alternative means of operating the business which has a lesser discriminatory impact, the employer/ contractor must investigate the appropriateness of ur.mg the alternative,3 (iii) The employer/contractor, as part of the data supplied to the enforcement agencies, shall include an evaluation of the alternatives investigated; (iv) There is a presumption that an employer/contractor who is not in compliance with occupational safety and health laws relating to the hazardous substance or condition has not considered ail available alternatives to exclusion. This includes all applicable OSHA standards, and all obligations imposed by section 5(a)(1) of the Occupational Safety and Health Act; (v) The enforcement agencies will consult with OSHA and others, as appropriate, on the relevant alternatives available in each particular situation; (9) Whether the employer/contractor is monitoring scientific research and technological developments which may affect the appropriateness of its policy. (e) Any evidence required by the enforcement agencies to show that an employer/contractor's conduct is non* discriminatory or justified pursuant to section 2(d) above must be made available by the employer/contractor to the enforcement agencies. The scientific evidence must be applicable to the 'Albemarle Paper Company v. Moody, 422 U.S. 407 (19751: Robinson v. Lonllard Corporation, 444 F. 2d 791 (4th Cir. 1971f. conditions in the employer/contractor's workplace where the particular substance is used. Sac. 3. Temporary emergency exclusion. There may be situations where an employer/contractor has obtained reputable scientific evidence that a workplace hazard causes or is likely to cause significant harm to the reproductive health of employees of one sex only, or of pregnant employees, and also where there is insufficient reputable scientific evidence concerning the reproductive harm to the other employees. (a) In such situations, the employer/ contractor may. as a temporary emergency measure, exclude susceptible applicants and remove endangered employees form the hazardous area provided the employer/contractor meets the following conditions: (1) It has thoroughly searched the existing scientific evidence and the search reveals no reputable scientific evidence sufficient to suggest that the reproductive hazard might have a significant harmful effect on the reproductive health of employees not excluded by the policy in question. (2) It has narrowly tailored its policy to limit any exclusionary impact solely to the group of employees or applicants endangered (see paragraph 2(d)(b). (3) It has investigated and adopted suitable alternatives (see paragraph 2(d) (8). (b) In addition to the conditions required under section 3(a)(1)--(3). within 6 months of the effective date of these guidelines, the employer/contractor with an exclusionary policy, practice or plan in existence on or before the date of these guidelines must initiate research designed to produce evidence of the effect of the reproductive hazard as used in the employer/contractor's workplace on the class not excluded. The employer/contractor developing such a policy, practice or plan after the effective date of these guidelines must initiate such research within six months of the implementation of the policy, practice or plan. (1) If the employer/contractor does not have the capacity to conduct or sponsor the necessary research, OSHA will be available to facilitate this research on request. Such a request for assistance should be addressed to: Director, Office of Legislative and InterAgency Programs, Occupational Safety and Health Administration, Department of Labor, 200 Constitution Ave., NW,, N- 3023, Washington, D.C., 20210. An approved request for assistance is sufficient to bring such an employer/ contractor into compliance with the requirement in Section 3(b) above as long as the employer/contractor subsequently cooperates with OSHA. (2] All such research must be conducted according to accepted scientific methods. The study must be conducted in a manner designed to produce the data on the class not excluded in the shortest feasible time, not to exceed two years, from the date the study was begun. An extension will, be granted only where the employer/ contractor can show that, despite good faith efforts, circumstances beyond its control prevented completion within the required time. (3) Employers/contractors are encouraged to sponsor or participate in these studies jointly. Such studies may satisfy the requirements of sections 3(b) and 3(b)(2). (c) The scientific evidence necessary to meet the requirements of sections 3(a) and 3(b) must be applicable to the conditions in the employer/contTactor's workplace where the particular substance is used. (d) The enforcement agencies will not take enforcement action pursuant to these guidelines against an employer/ contractor who meets the requirements set forth in section 3(a) and who meets the time frames established by section 3(b). However, this will not preclude the enforcement agencies from pursuing their administrative processes during the investigation of a charge or conduct of a compliance review, and docs not relieve an employer/contractor from complying with any appropriate administrative and investigative processes. (e) In any enforcement action brought by the enforcement agencies subsequent to the date by which an employer/ contractor must have scientific research completed as required in section 3(b). no compensation for backpay will be sought for the interim period as long as the employer/contractor has complied with the conditions in Sections 3(a) and 3(b). Sec. 4. Requirements for employer/ contractors with reputable scientific evidence. Where the search conducted pursuant to section 3(a)(1) above reveals reputable scientific evidence or where the employer/contractor has reputable scientific evidence that the reproductive hazard does not have a significant harmful effect on the reproductive health of employees not excluded, and the employer/contractor meets the conditions set forth in sections 3(a)(2) and 3(a)(3) above, then the employer/ contractor need not satisfy tho conditions of section 3(b). Authority: E.O. 11240, os amended and Title VII of the Civil Rights Act of 1964, as amended. (FR Doc. 80-3510 Filed 1-31-80 R45 am) BILLING CODE 6570-08-M <v^\- mvYS9* &v i ui_r 70P73 ,5 liuuSlOti MANAGER MANUFACTURING JUN 26 1979 copies LAL /TArJc DKG A RMD JFL C- RSK FILE U>. rO Jerry W. Ross o M. P. Breaux R. L. Gibson, M.D. C. Wen, M.D. C. H. Bowman J. Fitzpatrick J. R. Strausser T. B. Searcy D. O. Cantrell AT Houston 24 30 1HC 1600 2HC 833 GB 2460 2HC Philadelphia 4013 2HC 1552 WB 2438 1HC T COCHEM US. HOUSTON regulatory aefajrs RCT) Ji^rg.1979 Copy la W* DrcubJei'H. OATEJune 979 ceo y;y jep Wj 7 n?e ____ WMZ______ 1 Discussion 3 Handling 2 Cc.n.nenls 4 InfsKnolion Action Deadline ____________ Re: Exposure of Fertile Females to Teratogenic Substances in the Work Place At the March Epidemiology Subcommittee Meeting, the issue of exposing fertile females to teratogenic substances in the work place was discussed. Gulf Policy 309 outlines the basic manage ment decision of how such situations shall be handled. For purposes . * of implementing Gulf Policy 309, I offered to review the legal im-* plications of barring fertile females from work areas where tera togenic substances are found. . -* Attached is a memorandum by John Nation, a law clerk in this department, who researched the subject issue. John indicates that there is a court-made exception to Title VII of the Civil Rights Act of 1974 which is commonly known as the Business Necessity Rule. It appears that under the Business Necessity Rule, Gulf may have a ligitimate defense to an EEOC suit resulting from Gulf's decision to bar fertile females from work areas where teratogenic substances occur above threshold levels. This Business Necessity Rule exception appears to be the law in those areas where the technology does not exist to abate the terato genic exposure. An example would be at GOCHEM's St. James' facility where fertile females have been barred from working inside the plant due to benzene exposure. At St. James the risk of benzene exposure from upsets and equipment malfunctions is such that 1) it creates a ligitimate risk to any unborn fetus of a female employee and 2) is not a circumstance for which the technology exists to abate the risk. In those situations where the risk of teratogenic exposure to fertile females can be abated through the installation of abate ment equipment, there may be a legal obligation to install such abate ment equipment as opposed to barring fertile females from the work area. I would suspect that such obligation would depend on a large number of circumstances and conditions such as: cost of the abate ment equipment, the number of employees involved, etc. Gulf Policy 309 reflects a management decision to install such abatement equip ment where installation is technically and economically achievable. ... " -,,r,0045942 6 kr June 6, 1979 Page 2 Hopefully, John*s memorandum will be of some assistance in plementing Policy 309 and understanding its legal implications. If you have any questions, please contact me. JWR/djh Enclosure t F OM TO John D. Nation at Houston Jerry W. Ross at Re: Epidemiology Subcommittee Report IN REPLY Ftf.FH TO ``Hpril 23, 1979 EEOC IMPLICATIONS OF SEGREGATING FERTILE FEMALES FROM WORK AREAS INVOLVING USE OF TERATOGENIC SUBSTANCES Gulf Policy 309 (rev. June 1, 1977), Occupational Exposure to Toxic Substances, reads as follows: POLICY Gulf will use all feasible measures to prevent exposure of its employees in the ordinary course of employment to any known toxic substances or harmful physical agents which may have a deleterious effect on employee health or well being. ' PROCEDURE 1. The Gulf Medical and Health Resources Division of GS&[? shall identify chemical, physical and biological agents that elicit a teratogenic, mutagenic, carcinogenic or highly toxic effect. This Division shall determine the degree of hazard and recommend threshold limits of exposure. 4.a. Gulf will riot knowingly permit a pregnant female to / work in an area where there is medically substantiated exposure to substances hazardous to the fetus, and will require any female working in such areas to report any 0004594* suspicion of pregnancy immediately to the Company through the local Medical Representative. Removal of a pregnant -female from the work place because of the presence of hazardous agents will be in accordance with the Maternity Leave Policy #265 in the Human Resources Manual. c. Where the development of such protective equipment, warning systems or engineering controls is not tech nically or economically feasible. Gulf will not employ fertile women for work in areas where teratogenic exposure is probable and significant exposure is possible, because teratogenic exposure creates hazards to the fetus during the early period of pregnancy., when ' a female may not know she is pregnant and thus may not be able to protect the fetus from exposure to the harmful substances. There is some concern in implementing this policy that Gulf might be caught between a "rock and a hard place"; specifically its need to protect employees from toxic substances and its equal employment responsibilities. It is believed that should any employment discrimination suit be brought. Gulf would have a good Tine, of defense under the "business necessity" exception to Title VII of the Civil Rights Act of 1974. 42 U.S.C. 2000e (2 ) (a) (1) ,(2)(1976) provides: (a) Employers. It shall be an unlawful employment practice for an employer-- 2- - SAL 000045945 (1) to fail or refuse to hire or to discharge any individual, or otherwise to discriminate against any individual with respect to his com pensation, "terms, conditions, or privileges of employment, because of such individual's race, color, religion, sex, or national origin; or (2) to limit, segregate, or classify his employees or applicants for employment in any way which would deprive or tend to deprive any indi vidual of employment opportunities or. otherwise adversly affect his status as an employee, because of such individual's race, color, religion, sex, or national origin. There is a court-made exception to this provision, applicable to both racial and sexual discrimination suits, commonly known as the business necessity rule. Briefly, this rule states that an admittedly discriminatory employment practice will nevertheless be upheld by the courts if it is necessary to the safe and efficient operation of the employer business. As developed by the courts in cases such as Robinson v. Lorillard Corp., 444 F.2d 791 (4th Cir. 1971), cert, dism1d, 404 U.S. 1006 (1971), the rule has emerged with three basic requirements: 1) the business purpose must be sufficiently compelling to override any sexual impact; 2) the challenged practice must effectively carry out the business' purpose it was designed to serve; and 3) there must be available no acceptable alter native practices or policies which would accomplish the business purpose advanced, or accomplish it equally well with a lesser differential sexual impact. -3- % |... () 0 () () 4 J::[ Q Very few challenged employers have used this doctrine as anything other than a dilatory defense. Most simply throw up the defense without attempting to develop a case under it. Yet in one case, an employer has carefully developed his case and squarely prevailed under the safety prong of the business necessity rule. In Boyd v. Ozark Airlines, Inc., 419 F. Supp- 1061 (E.D. Mo. 1976), aff*d 568 F.2d 50 (8th Cir. 1977), Ozark had a minimum height requirement of 5*7" for pilots. Plain tiff, a trained female pilot, was only 5*2"- The court agreed with the plaintiff that the practice was prima facie discriminatory. Thereupon, Ozark set up the business necessity * defense. Ozark pointed out that the cockpits of its airliners were designed around a design eye reference point. When a pilot was seated so that his eyes were in this reference point, he would have the ability to see over the glare shield of the plane and still be able to view and reach all the controls. Should the pilot sit below the reference point, the changed angle of vision could cause a distorted vision of the ground below, causing landing difficulties. Ozark tested the plaintiff in the cockpits of both its / plane types, the FH227 and the DC-9. When seated at the design eye reference point, she was unable fully to rotate the whel in one, and could rotate the other only barely, with less the minimum safe rate of clearance between body and wheel. The court said that the evidence clearly indicated that plaintiff at a height of 5*2" could not safely fly OzarkTs aircraft. (The company was, however, ordered to lower the,height requirements to 5'5"). Applying the doctrine to the present situation. Gulf should easily be able to show that the necessity for separating fertile females from teratogenic substances is sufficiently compelling to override the sexual impact. It is also evident that the practice carries out the business purpose of main taining employee safety. In determining whether an employment practice is justified by the business necessity rule, it is significant to note that the courts will look to methods used by other similar companies in dealing with the same problem. In Boyd, the court looked to minimum Height requirements as established by other carriers such as American, Continental, Delta and the military. Their height require ments were in substantial accord with Ozark*s. Similarly, Gulf should be able to show that other companies who use teratogens follow the same practice. In a hearing before the National Safety Congress on October 3, 1978 (reported in OSHA REPORTER, October 5, 1978 pp. 56970), Richard L. O'Connell, Director of Corporate Health Affairs and Leonard Krause,. Director of Environment Hygiene and Toxicology for Olin Corporation outlined Olin Company policy on exposure to teratogens. Krause testified that Olin segregates fertile women from areas where there will be substantial contact with known or suspected teratogens. -5- 8 A l- :}0045 Where work will involve only limited exposure, Olin allows females to work in such areas after the signing of a waiver. Thus, it should he easy for Gulf to show the hazard and the necessity for segregation. The third prong of the test requires further analysis. Gulf must be able to show that there are no alternative policies which would accomplish the same result with a lesser discriminatory impact. The logical interpretation of this is that Gulf must show that there is absolutely no alternative to refusing to hire fertile women in workplaces involving teratogens. However, in its search for alternative policies, a court might inquire whether the nuisance can be abated. If, for instance, it is possible and feasible^'to remove the teratogens, or develop protective and/or warning systems, a court might hold that the company has not satisfied the third prong of the business necessity rule. If, however, exposure to teratogens cannot be eliminated and warning and protective systems are not technically or economically feasible, a court would probably decide-that there is no alternative to segregating fertile females from teratogenic exposure. analysis. No court, however, has undertaken this kind of / The Boyd court noted that Ozark had no control over the specifications and design of the cockpits of their aircraft, but it is not clear whether the court would have required Ozark to change the design in order to accommodate shorter pilots had it been in their power to do so. o A L 0 00 0 4 !::i V 4 6- In conclusion, it must be emphasized that there is little law respecting equal employment implications of segregating fertile women from workplaces involving terato genic exposure. Leon J. Warshaw, speaking at the same National Safety Congress, argued that a definitive solution to this problem does not exist, and that the only alternative route is through compromise among industry, labor and the EEOC. What form any compromise would entail and what guidelines will be issued by EEOC are unclear. However, should an employment discrimination suit be brought. Gulf should have enough material to build a sound defense under the business necessity exception to Title VII. John D. Nation JDN:map -7- (it O000459b0 L. U i ' xLi J )bS? final standard and therefore is too low, Deakins told the court. A "conservative estimate" would be at least 51 billion, he added. A stay. Is necessary because substantial sums would have to be committed soon to meet the final deadline of September 1982, according to Deakins. Dennis Kade, of the office of the Solicitor of Labor, dis puted the industry's contention that substantial expenditures must be made in the near future. Kade noted that initial monitoring of exposure levels need not he completed until March 1979, and suggested that orders for control equipment could not be placed before then. In response to a question from the court, Kade stated that DDL would have no objec tion to an expedited review proceeding. Jeremiah Collins a Washington, D.C. attorney, speaking for union intervenors, assured the court that employees in the textile industry are willing to wear respirators when necessary. The arguments were heard by Circuit Judges H. Emory Widener, John D. Butzner, Jr., and Kenneth K. Hall. Judge Widener dissented from the order of transfer. Litigation DOL CANNOT GIVE MANDATORY EFFECT TO ADVISORY CRANE RULE, COURT RULES The Secretary of Labor exceeded statutory authority by giving mandatory effect to a standard derived from an ad visory private rule on cranes, according to the U.S. Court of Appeals for the Third Circuit. The court, in Marshall v. Pittsburgh-Des Moines Steel Company and OSAHRC (No. 77-1809) and Marshall v. Wkeeling-Pittsburgh Steel Corporation, Wheeling Corrugating Company, and OSAHRC (No. 77-1810), held that the guarding requirements of 29 CFR 19J0.179(e)(6)(i) and (g)(2)(i) are merely advisory for cranes constructed before August 31, 1979. The Oc cupational Safety and Health Review Commission had reached the same conclusion (5 OSHC 1420 and 1495). The secretary promulgated the crane standard as a "national consensus standard" under Section 6(a) of the Oc cupational Safety and Health Act. The Labor Department regulation, in a genera! subsection on applicability, says that cranes constructed and installed after August 31, 1971, "shall" meet the design specifications of the American National Standard Safety Code for Overhead and Gantry Cranes (ANSI B30.2.0-1967). Cranes constructed before that date, on the other hand, "should" be modified, according to 29 CFR 1910.179(b)(2). The court agreed with the Labor Department that the regulation was intended to be mandatory in its entirety. When first promulgated, it used the term "shall." The secretary stated that changes made in a revision 10 weeks later -- including the change back to "should," the term used In the American National Standards Institute standard -- were not intended to be substantive. The court held, however, that Section 6(a) of the Act did not authorize the secretary to give mandatory effect to the advisory portion of the ANSI rule. Such a change would have been proper only if Section 6(b) rulemaking procedures were followed, the court said. "The overriding ameliorative goals of the statute cannot justify circumvention of its procedural requirements, the court concluded. The Labor Department also urged that the subsections on guarding of parts and equipment were enforceable in their own right, although they were derived from the ANSI safety code. The genera! subsection, whether advisory or man datory, was irrelevant because the guarding requirements were concerned with construction and installation and not with the crane's basic design, the Government said. The court responded that the ANSI code, the source of the subsection on applicability, was not limited to design- oriented standards. That code's introduction used the terra "rules" rather than "design specifications." The court also said that it was relying on the "plain wording of the stan dard" in finding the guarding requirements to be design specifications. . . .- Chief Judge Collins J. Seitz wrote the opinion. He was join ed by Senior Circuit Judge Francis L. VanDusen and Circuit Judge Max Rosenn. The decision will appear in a future Decisions supplement '.. : Cotton Dust AGRICULTURE APPROPRIATIONS APPROVED; $700,000 INCLUDED TO STUDY OSHA RULE The' conference committee's report on the Department of Agriculture appropriations for fiscal 1979, which includes a provision for a study of the Occupational Safety and Health Administration's cotton dust standard, was approved September 26 by the House and September 27 by the Senate. The Senate originally approved 200,000 to fund a National Academy of Sciences study to review OSHA's cotton dust standards (29 CFR 1910.1043 and 1910.1046) which were issued June 23 (Current Report, August 17, p. 382)'. The report of the conference committee, which resolved differences between the House and .Senate versions of-the bill, stated that the conferees fully supported the need for such a study, but they said that 100,000 is the most such a study will cost The bill has been sent to the White House and is awaiting action by the President. . Health Hazards RIGHTS, PROTECTION FOR PREGNANT WOMEN IN WORKPLACE OUTLINED AT SAFETY CONGRESS CHICAGO ILL. -- (By an OSHR Staff correspondent) -- Exclusion of women of childbearing age from potentially hazardous work situations that may affect reproductive capacity will not solve the problem of protecting the rights of women in the workplace, the National Safety Congress was told October 3. . Leon J. Warshaw, vice president and corporate medical director. Equitable Life Assurance Society of the U.S., declared that a definitive solution does not exist to the problem of health hazards affecting pregnant women in (he workplace. However, he outlined some "acceptable com promises" for industry, labor, equal opportunity officials, and the women themselves. Warshaw explained that there are some jobs that (he preg nant woman cannot perform and others that she should not attempt because of potential hazards to herself or to her un born child. Normal women are no more susceptible to workplace hazards than their male counterparts, he said, but "pregnancy changes this." The ideal would be to make the workplace safe for all workers, Warshaw declared, but this is not possible for many reasons including technical constraints and prohibitive ^ cost. Some problems of health hazards of women of UV&-78 Copyright & 1978 by The Bureau of National Affairs, Inc. OOSS-3237/7 B/SDOSO 3 A i... 0 0 0 O 4 5 y != | b70' ii OCCUPATIONAL SAFETY & HEALTH REPORTER ' childbearingage involve exclusion from some jobs, retention of the pay rale at the new job, seniority protection, dis crimination claims, and the right to privacy. Decisions are needed on a case-by-case basis, Warshaw .aid, with the debate and discussion to include management, labor, women's rights groups, and the employee herself. He recommended an industry policy which would provide that: >- The health of the worker and herunborn child be given prime consideration. - The employee be given the best professional advice on family planning and prenatal car >- a system be established to provide workers with informa tion on potential workplace hazards and guidelines provided to help employees make decisions regarding the continuation of such work. --.....` An educational program be established for females of childbearing capacity to avoid or control hazards in their personal lives such as drugs, alcohol, smoking, and exposure to household chemicals. >- Research be conducted on new chemical and possible mutagenic effects, with the results of such research divulg ed to those who may have been exposed and the right of the worker to that Information to outweigh consideration of trade secrets. Companies and unions endorse a code of ethics for health in the workplace, and insist that all health professionals conform to its precepts. All of this is "eminently possible" if industry hires proper professionals and unions emphasize the health of the workers, Warshaw explained. He called for honesty, dignity, equality, and compassionate treatment of female workers and their male counterparts. Richard L. O'Connell, director of corporate health affairs, lin Corporation, Stanford, Conn., declared that women uelong in the workplace, but he urged industry to recognize that there are unique needs and characteristics of women ' that must be accommodated. He outlined the physical changes which take place in preg nant women and listed possible problems of pregnancy which could be the results of workplace situations or which could affect a female's performance on the job. He warned that there are some substances in the workplace that could lead to miscarriages. O'Connell also cited teratogenicity problems and explain ed that these involve whatever interrupts the fetal growth process. Chemicals recognized by the National Institute for Occupational Safety and Health as teratogens, O'Connell said, include cadmium, carbaryl, carbontetrachloride, chromium compound, 4--dimethylaminozobenzene, for maldehyde, lead, mercury, oxides of nitrogen, paraquat, and parathion. He cautioned against "panic" regarding other lists and possible effects from other substances until they are proven teratogens. ,f Leonard Krause, director of environmental hygiene and toxicology, Olin Corporation, New Haven, Conn., described his company's policy regarding women of childbearing age in the workplace. He said the problem must be addressed as more women between the ages of 16 and 45 enter the workforce and as more hazards are recognized that may affect them. Krause explained that Olin's policy involves ongoing evaluation of each case of possible hazards to employees. There are three categories for placement of women of lildbearing age within the company he said. The first is the restricted category where work may require contact and ex posure to known or suspected agents which could harm women of childbearing age. Such women are prohibited from working these restricted areas. A "controlled category1' involves limited contact where discretion is allowed. Women may work in such areas but sign a form to show that they have read a guide on prenatal chemical or physical exposure in such controlled areas. The third category is for the unrestricted area in which ex posure docs not constitute a hazard, Krause said. Corporate industrial hygienists and toxicology depart ments should analyze each job, determine to which classi fication the employees would belong, Krause explained, and specify limitations for females of childbearing age. Cotton Dust CARTER DEFENDS PROPOSED STANDARD ; AS "REASONABLE" BEFORE THE NAFB . President Carter defended his proposed cotton dust stan dards September 29 in an interview with the National' Association of Farm Broadcasters held In Washington, D.C. Answering a charge that the proposed standards will "close down" segments of the cotton industry. Carter stated that the regulations, which would lower the permissible level of airborne cotton dust in mills and textile plants, are "reasonable." He further asserted that the standards and method of en forcement advocated by the previous administration would have cost industry an estimated $2;7 billion, while the ones issued by the Labor Department September 4 had cut that cost substantially, perhaps to one-fourth. Carter expressed his belief that, although the regulations currently are being challenged by the National Cotton Coun cil, the "courts will rule in favor" of the standards.-- The Senate recently voted to suspend Ihemew regulations until May 1 in an amendment to the appropriations bill for the Departments of Labor and Health, Education, and Welfare. Asbestos BALTIMORE SHIP WORKERS TO BE STUDIED BY MOUNT SINAI MEDICAL CENTER TEAM A union local representing workers at two Bethlehem Steel shipyards in Baltimore has arranged with the Mount Sinai Medical Center of New York to conduct an occupational dis ease study of present and retired workers. Bob Pemberton, business agent for Local 24, Industrial Union of Marine and Shipbuilding Workers of America (AFL-CIO), said the membership, numbering about 1,700 had approved the agreement for the study by Mount Sinai, expected to get under way within a few weeks. Pemberton said the members hoped that "if there is something we can do to help prevent disease for the people who are working here now," the study would find iL While asbestos-related disease will be one health effect looked for,' Pemberton said, comprehensive medical ex aminations will be given to present and former ship workers to discover any type of occupational disease patterns. Individual test results will be given to each worker who is examined, Pemberton said, but these findings will not be seen by the union, as the agreement stated. The union will see overall statistical results but not the individual identities of workers, according to Pemberton. The statistics will be used to identify health effects by crafts within the local. Some of the crafts at the Bethlehem facilities are boilermakers, firemen, sandblasters, black smiths, carpenters, and joiners. 70-5-78 OccupationoT Solely A Hecllh Reporter 009S-3237/7A/S00.50 The following is a commentary on those issues surrounding women in the workplace. Three significant trends have led us to our present discussions, with a call for more research into the reproductive effects of chemical and physical agents. Women in the workplace, the issues FRANCIS Y. FALCK, Jr, School of Public Health, University of Michigan. Ann Arbor. Ml 48104 and member, Law Committee, American Industrial Hygiene Association introduction The following information is not being offered as legal interpretation or legal advice but rather it is information which should be of some aid when discussions arise regarding women in the workplace. The exposure of women of childbearing age to potentially With that, let's examine the first trend on our list, the shift of women to employment outside the home. The changing pattern of employment of women over the last 50 years reflects a basic transformation in American life, precipitated by a variety of reasons. harmful agents has recently received a great deal of attention among health professionals and the general public. This has generated a host of medical, legal, and social issues, many of w hich are still unresolved. discussion It has been mandated by legislation that the female adult has che right to employment in those occupations that were formerly only occupied by the male adult. Out of concern for the health of the individual female adult and her offspring, many employers have adopted exclusionary policies for women of the childbearing age. This has been interpreted as a threat to women's recent progress towards equal footing with men in the area of employment. It has been suggested that three noteworthy trends*have led us to those discussions and issues that surround our present subject at hand. These trends are as follows:01 The shift of women to employment outside the home The social objective of equal employment opportunity The social objective of safe and healthful work places and concomitant knowledge about environ mental health hazards Implementation of the objectives has led to the passage of regulations and laws which may be interpreted as being conflicting. A close examination of the subject at hand will reveal the dependence of society upon the interelationship of law and science to resolve conflicts and issues that may arise. In this case, one may be outdistancing the other. It is generally conceded that at the present time science does not have sufficient answers to existing and arising questions concerning the effects chemical and physical agents may or may not have upon the reproductive process of both men and women. The growth in numbers of women in the workforce is becoming significantly greater with the passage of time. The number of women employed, on an average annual monthly basis during 1978 was approximately 42 million, 32 million of whom were full-time. Therefore, out of a total workforce of 100 million individuals, women comprise 42 percent. Of those 42 million women in the workforce, approximately 30 million or 71 percent are of childbearing age (16-44 years). Using a fertility rate of 67.8 live births per 1000,women reveals a possibility of 2 million pregnancies to those employed in any recent year. In addition, approximatley 3 million of those women, of childbearing age, are employed in industries where exposure to a reproductive hazard may possibly occur.12' Obviously not all women of childbearing age face the same risk. Men and women having current reproductive capacity may choose not to exercise it, be practicing birth control, or postponing with the desire to conceive in the future. Additionally, there are those without reproductive capacity due to age, injury, illness or surgery. Therefore, the possibility of 2 million pregnancies may be significantly exaggerated. The second significant trend or social objective, namely equal employment opportunity, has spawned a continuous stream of enacted statutes with concurrent interpretations. The most significant of these statutes is Title VII of the Civil Rights Act of 1964 as amended by the Equal Employment Opportunity Act of 1972. In addition. Executive Order No. 11375 not only prohibits discrimination by Federal Con tractors but also mandates affirmative action. Enforce ment of this order is administered by the Office of Federal Contract Compliance whereas enforcement of Title VII is through the Equal Employment Opportunity Commission. Just recently four Federal agencies, the Civil Service Commission, the Equal Employment Opportunity Commission, the Department of Labor, and the Department of Justice adopted the Uniform Guidelines on CaovflrK'SB0. hmttteati liuunrwi Hygiene Association American Industrial Hygiene Association JOURNAL (41) 3/80 fI Employee Selection Procedures of 1978 which are intended to establish a uniform Federal poshtion in the area of prohibiting discriminatory practices on grounds of race, color, religion, sex, or national origin. The Guidelines are applicable to tests and other selection procedures which are used as a basis for any employment decision. So as one can see, significant legislation has been enacted that nearly covers all aspects of discrimination relating to employment. However, interpretation and application of each appears to vary significantly depending upon the setting and locale. As mentioned previously. Title VII of the Civil Rights Act appears to be the most significant statute enacted to date. Sec. 703 of Title VII of the Civil Rights Act of 1964 as amended by the Equal Employment Opportunity Act of 1972 states: A.) It shall be an unlawful employment practicefor an employer -- 1.) To fail or refuse to hire or to discharge any individual, or otherwise to discriminate against any individual with respect to his compensa tion, terms, conditions, or privileges of employment, because of such individuals . . . sex . . . or; 2.) To limit, segregate, or classify his employees or applicants for employment in any way which would deprive or tend to deprive any individual of employment opportunities or otherwise adversely affect his status as an employee, because of such individuals . . . sex . . . Initially, Title VII of 1964 as enacted, applied only to private employers. At that time an employer was defined as a person engaged in an industry affecting commerce who had 25 or more employees for each working day in each of 20 or more calendar weeks in the current or preceding year.13' However, Title VII as amended by the Equal Employment Opportunities Act of 1972 reduced the number of employees needed for an employer to be covered to 15 and removed the exemption of state and local governments. Although the U.S. Government is not included under the definition of employer, it is still required to be made free of discrimination (Executive Order 11375). Looking at the specifics of Title VII leads one to the interpretation that all classes of workers must be treated alike; no differential treatment is tolerated. The prohibition against sex discrimination requires employers to treat employees in a "sex blind fashion", i.e. elimination of such classifications as men's work vs, women's work.(4> Thus if an employer adopts an exclusionary policy for any class of worker it would appear that this would be a violation of Title VII. Guidelines on discrimination because of sex have been published by the Equal Employment Opportunity Commission in CFR 29, Chapter XIV,. Part 1604. The guidelines are basic interpretations of Title VII as related to sex discrimination and are applicable to cases and charges filed with the Commission. The Office of Federal Contract Compliance has also published similar guidelines in 41 CFR, Part 60-20. Part 1604.3 (a) of the guidelines states as follows: "It is an unlawful employment practice to classify a job as 'male orfemale'. .. accordingly, employment practices are unlawful which arbitrarily classifyjobs so that: l.) A female is prohibited from applying for a job labeled "male" orfor ajob in a "male" line ofpro gression and vice versa. In addition under the same section, Paragraph (b) also states: "A seniority system or line of progression which distinguishes between a "light" or "heavy" job constitutes an unlawful employment practice if it operates as a disguisedform ofclassification by sex, or creates unreasonable obstacles to the advance ment by members of either sex into jobs which members ofthat sex would reasonably be expected to perform." Although Title VII of the Civil Rights Act prohibits discrimination, an exception is offered by Sec. 703 (e) which states: "It shall not be an unlawful employment practicefor an employer to hire and employ employees... on the basis of.. . sex ... in those certian instances where sex ... is a bona fide occupational qualification reasonably necessary to the normal operation ofthat particular business or enterprise . . . Again the E.E.O.C. Guidelines on sex discrimination provide the following interpretation: "The Commission believes that the bona fide occupational qualification exception as to sex should be interpreted narrowly . . . 1.) "The Commission will find that the following situations do not warrant the application exceptions:" i) "The refusal to hire a woman because of her sex based on assumptions of the comparative employment characteristics of women in general..." ii) "The refusal to hire an individual based on stereotyped characterizations ofthe sexes. .. the principle of non-discrimination requires that individuals be considered on the basis of individual capacities and not on the basis of any characteristics generally attributed to the group." Based upon the above guidelines, it is easy to assume that the application of a bona fide occupational qualification is very narrow indeed and use of it to provide relief from a 1S8 c; AI 0 0 0 0 4 bk; 'q'';4 Am. Ind. Hyg. Assoc. J. (41) March. 19BC j,crimination charge for exclusion of a given class of workers from a particular environment would be difficult. K's only application appears to be in areas of artistic endeavor as the following quote from the guidelines yield: Where it is necessaryfor thepurpose ofauthenticity or genuineness, the Commission will consider sex to be a bona fide occupational qualification, e.g., an actor or actress" To date, according to the E.E.O.C., no bona fide occupational qualifications have been granted for an exclusionary policy regarding reproductive hazards. However, it is important to note that it was indicated that theB.F.O.Q. has not been tested under these circumstances. The philosophy indicated by the O.F.C.C.P. and the E.E.O.C. regarding exclusionary policies is somewhat interesting. It was noted that if an employer maintains an exclusionary policy for a particular class, that employer must present scientific conclusive evidence that demon strates. not only that the excluded class is exposed to a risk, but also that the unexcluded class is not exposed to the same or similar risk. In other words "a universally disproportionate risk exists." Extrapolating this to a policy of excluding pregnant or fertile women would possibly indicate the following if in fact the above philosophy were to be enforced relating to Title VII. 1. The employer would have to present scientific evidence that the substance has been conclusively identified as a teratogen, and 2. that conclusive scientific evidence has indicated that the substance is not a mutagen, carcinogen, gametotoxin; or does not cause sexual dysfunction. The above circumstance is only hypothetical, however, the important issue is that the teratogen classification indicates sex-specificity. The above task would appear to be near impossible to attempt. The philosophy was only indicated and it was noted that guidelines on the subject may soon be published by these agencies. At present it is estimated that 63,000 chemicals are in use,'3* the majority of which have not been investigated as to reproductive effects. Current standards addressing the problem are also lacking and, as mentioned previously, a close look at the issues involved reveals the interelationships of law and science.'6* It appears that in this particular situ ation one is out-distancing the other, current scientific information regarding reproductive effects has not routinely been addressed during the rulemaking process. However, recently some changes in the standard setting process have taken place regarding the issues at hand and with that let's look at the second social objective, safety and health. Congress has delegated the responsibility of assuring safe and healthful working conditions for "working men and women" to the Occupational Safety and Health Adminis tration within the Department of Labor. American Industrial Hy|iene Association JOURNAL (41) 3/80 Public Law 91-596, Section 6, Paragraph 5 yields the following provision for regulation of toxic substances: "The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents .... shall set the standard, which most adequately as sures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capa city ..." It is important to note that the word feasible has specific limitations, most recent of which its definition has been implied to be of economic feasibility as a result of a Circuit Court decision on the Benzene Standard. However, putting that aside, OSHA has put forth the following interpretation of both the Act and more specifically Section 6 as it relates to issues about reproductive hazards: "At OSHA we are dedicated -- and it is our legal responsibility -- to assure so far as possible safe and healthful workplaces for all workers -- men and women. And that includes protection of all functional capacities, including the reproductive capacity.'*1' With this responsibility in mind, reproductive issues were of major significance in setting an acceptable lead standard. In fact, a great deal of testimony centered around the effects lead has upon the reproductive process of both men and women as the following quote yields: "OSHA has concluded that damage to thefetus due to parental exposure to lead represents material impairment of the reproductive capacity of the parent involved'**' The lead standard appears to be the first of its kind, in that in setting a permissible exposure level, the issue of repro ductive functional capacity was paramount. conclusion If we are to close the gap between law and science in this particular area, then the need for information on the reproductive effects of the other 63,000 chemicals is very important indeed. If OSHA is to continue to maintain its current responsibility and/or interpretation of functional capacity which encompasses reproductive capacity, in setting those standards which assure safe and healthful working conditions for men and women, a new, possibly overdue emphasis upon the regulation of toxic substances may be on the horizon. Overall, it would appear that a coordinated effort is necessary' between those agencies responsible for adminis tration of the social objectives that have been discussed here. In closing, I would like to use the following quote of Dr. K.P. Russel; "The obstetrical axiom that we are always dealing with two individuals rather than one is well known. but not always appreciated. For it is not thepregnant 159 worker alone with which we should be concerned, but also the health ofthe unborne. To be well-borne should be the basic right ofevery fetus." references 1. The American College of Obstetricians and Gynecolo gists: Guidelines on Pregnancy and Work. D.H.E.W. (NIOSH) Publication 78-118. Cincinnati. OH (1978). 2. Department of Labor, Bureau of Labor Statistics: Status of Civilian Labor Force by Age, Sex, and Major Industry Group. Tables 9 and 10. Washington, DC (1978). 3. Equal Employment Opportunity Commission, Subcommittee on Labor: The Equal Employment Opportunity Act of 1972. Title VII of Civil Rights Act of 1964 Showing Changes Made by Public Law 92-621. Approved March 24, 1972, U S Government Printing Office, Washington. DC (1972}. 4. Samuelson, J.I.: Employment Rights of Women in the Toxic Workplace, Calif. Law Rev., Univ. Calif. 65:1118-1122 (1977). 5. Science. (January, 1978). 6. Allan, R.E.: Medical-Legal Aspects. American Industrial Hygiene Association, OH (1978). 7. Bingham, E.: Address presented to the NIOSH/SOEH Workshop on the Assessment of Reproductive Hazards in the Workplace, (1978) 8. Occupational Safety and Health Administration: Attachments to the Preamble of the OSHA Rule for Workplace Lead Exposure, p. 1031. 43FR54354 (1978). Volunteer peer reviewers for AIHAJ manuscripts sought . . . In placing submitted manuscripts for peer review, the members of the Editorial Advisors Committee draw on their personal pool of colleagues, as well as others in the profession whose specialties make them best suited to evaluate a particular manuscript. In certain instances, they consult with each other to locate a qualified reviewer. Occasionally, a manuscript's subject is so specialized that the author is asked to submit a list of qualified reviewers, not connected with him professionally or personally. From this list a reviewer is selected and contacted. Each manuscript receives at least two reviews, one by the reviewer and a verification review by the editorial advisor. Quite often, two reviewers are used on the initial review, plus the advisor's review. When a manuscript is judged in need of major revision and a second review, the revised work is evaluated by the same advisor and reviewer(s) who handled it initially. Third reviews are not uncommon. Often, individuals express an interest in reviewing manuscripts. To broaden the scope of reviewer availability, we are calling for volunteers willing to review a reasonable number of submitted manuscripts annually. Identity of the reviewer is not revealed to the author without the reviewer's per mission. To volunteer, please write to the Editor, American Industrial Hygiene Association JOURNAL, 475 Wolf Ledges Parkway, Akron, OH 44311. In a one-page letter, state your interest in reviewing, your mailing address and business phone number. List your areas of expertise and interest, together with a brief summary of your experience and qualifications. All letters received will be duplicated and forwarded to the editorial advisors. When the need arises, they will contact the volunteer determined to be best suited to review the manuscript they are processing. All interested are urged to submit a letter, as described above. A similar call for volunteers was made some time ago and a substantial number of replies were received. These went out to the advisors group serving at that time. Since then, a number of changes in the advisors roster have taken place. So that we will have current information on file, even though you have volunteered in the past, submit a current letter of .interest. The first distribution of volunteer letters to the editorial advisors is planned for April 15, 1980. To be included, your letter must be received no later than April 7, 1980, SAL 0000459 180 Am. ind. Hyg. Assoc. J. (41) March. .980 (conoco) Interoffice Communication To Plant Managers Prom R. E. Lehmkunl Daw October 31, 1979 Subject Guidelines for Employment in Chemical Plants cX' K l''~ U le 4 Attached is a copy of my letter dated August 27 and a copy of Dr. Lembke's letter of October 17 in reply. If you have any questions concerning any part of the guidelines, please advise D. L. Norwood. Please implement these employment guidelines immediately. cc: R. W. Gerv/ig - Stamford J. D. Burns - Houston J. J. Hall - Houston D. L. Norwood - Houston"*-- D. C. Bartlett - Houston Flynt Kennedy - Ponca City D. A. Kuhn - Houston 0. E. Landers - Stamford R. L. Lembke, M. D. - Ponca City L. C. Reed - Houston S. E. Conly - Houston D. E. Nicholson - Houston T. D. Montgomery - Legal, Houston M. A. Fisher Legal, Houston CAI- 0000 45?'K7 v: iWI IVViW interoffice Communication To R. Lehmkuhl - Houston Prom Robert L. Lembke, M.D. - Ponca City Date October 17, 1979 Subject GUIDELINES FOR EMPLOYMENT IN CHEMICAL PLANTS JiT 1 9 1979 After receiving your interoffice communication on the above subject dated August 27, 1979, I read it carefully and then circulated it to the other physicians and industrial hygienists in the Medical Division for their information and for any comments which they might like to make regarding its contents. Just yesterday, the interoffice communi cation was returned to me because in the interim many of the physicians and industrial hygienists were away from the office on company business. All of us concur that the guidelines as set forth by you are appropriate and none of us disapprove of any statements which you have made. Robert L. Lembke, M.D. Medical Director jr cc: R. W. Gerwig, Stamford J. D. Bums, Houston D. A. Kuhn, Houston D. L. Norwood, Houston M. A. Fisher, Houston T. D. Montgomery, Houston c; a, | () 0 0 0 4 59 b 3 interoffice Communication To R. L. Lembke, M.D., D, E. Nicholson Fro/n Dot* R. E. .Le-hmkuhl August 27, 1379 _- Subj*c: GUIDELINES FOR EMPLOYMENT IN CHEMICAL PLANTS received A US 2 9 1979 Donald L Scrsooc Any comprehens?ve policy for employment of men and women in our chemical plants must be compatible with sometimes conflicting restraints. It must give workers ample protection from hazards In the workplace yet be non-dI scriminatory where there is no reason to employ one sex but not the other. The subject guidelines are believed to strike a balance that will satisfy both requirements even in plants where chemicals such as benzene or vinyl chloride are found. The policy is not without risk to employees or Conoco. Indeed, we cannot provide a "risk-free11 workplace for anyone. We believe, however, that the policy sat Isfactorily balances the needs to provide ample employee protection, maintain equal opportunity and keep the risk of costly litigation for Conoco low. Please review this program and determine if It represents an acceptable course for Conoco Chemicals. POLICY ` " ~ - -4---------------------- -------------------------------- (1) Maintain the workplace in compliance or better with pertinent OSHA standards. Where OSHA standards do not exist, abide by industry consensus standards. When neither of these exist, establlsn Conoco standards, comply with them and exercise prudent control of all other chem ica1s . (2) Explain in detail to each employee at the time of initial hire and on a regular basis thereafter: (a) What chemicals are present In the workplace and the s.afe practices for working near and handling these chemicals; (b) What information we have about the potential carcinogenic, mutagenic, teratogenic, and other health effects of any chemicals . in the workplace, the levels at which these effects have been known to occur and the fact that we maintain our exposures below these levels. (3) Assure that the safe practices are enforced. (k) Employ anyone capable of performing the job satisfactorily without regard to sex, race, age, or other non-performance standard. BENEFITS OF THESE GUIDELINES SAL 00004595? (l) - We maintain a workplace that amply protects the safety and health of everyone. R, L. Lembke, M.D., 0. E. Nicholson Page 2 August 27, 1579 (2) We have a policy that responds properly to the requirements of occuoational safety and health as well as equal opportunity.' (3) We are able to reach our goals of employing more women in our opera tions, especially femaie chemical engineers at entry level jobs for future assignments in management. (A) We open up for our recruiting a larger resource base (women) where there are qualified candidates. Our success with this group may be better because other companies exclude them from consideration. RISKS If a claim is brought by a worker against the company for an alleged injury or -illness when we are fully complying with OSHA, consensus or Conoco stand ards, It is likely that we would be liable for workmen's compensation alone and would not be susceptible to a negligence suit. On the other hand, the developing fetus is not a '`worker11 so presumably a malformed child could sue the ccmpany for putting him at an unacceptable risk in the workplace. Since there is no precedent for this kind of case, 1 cannot Imagine what the out come would be. However, considering the number of women in our employ, the number who will get pregnant, the known percentage of birth defects as well as the probability of suit, and the burden on the plaintiff to establish a causal link between the malformation and the parent's exposure to chemicals, the likelihood of such a suitjs small. Further, while 'the risk of liability is not eliminated through this policy, our present:policy does not eliminate the risk of such a'suit cn behalf of the deformed fetus as a result cf the father's exposure to toxic chemicals. a io R. W. Gerwig J. D. Burns D. A. Kuhn D. L. Norwood M. A. Fisher 7. D. Montgomery - Stamford - Houston - Houston - Houston - Legal, Houston - Legal, Houston iB