Document VjdbwVqJ7EdydkkgqXdxjjaEw

1 S i*' Mo. 41 January 31, 1980 THE OSHA CANCER POLICY On Friday, January 19, 1980, the Occupational Safety & Health Administration (OSHA) issued the "OSHA Cancer Policy" entitled "Identification, Classification & Regulation of Potentia Occupational Carcinogens". Although no specific chemicals are addressed in this statement of regulatory policy, the policy establishes the criteria and procedures under which specific substances will be regulated by OSHA. Incorporated as part of the Code of Federa Regulations, the policy addresses the scientific evidence, subjective, and policy judgment OSHA will use in determining which of several thousand, potential carcinogens to regulate. The policy also establishes a step-by-step process for writing specific regulations far - potential carcinogens. ' .. 4 In the "Cancer Policy" OSHA combines a reiteration of authority granted to the Agency by the OSHA Act of 1970 (P.L. 91-569) with specific statements as to "Classification, Priorit; . Setting, Initiation of Rulemaking, Model Standards, Scientific Review, and other sub issues to he considered under the umbrella policy. General The policy governs the identification, classification, and regulation of potential occu pational carcinogens to most adequately assure "to the extent feasible, on the basis of the best available evidence, that no employe will suffer material impairment of health ' or functional capacity even if such employe has regular exposure to the hazards dealt ^ with by such standard for the period of his or her working life." The definition of a * potential occupational carcinogen' (POC) is essentially that accepted by the National Cancer Institute and is described as any substance that directly causes, increases, or enhances a benign and/or malignant neoplasm in one or more mammalian species by appropriate route of entry. Chemicals metabolized by mammals to POC'a are included in this definition. The policy establishes two categories (rather than four as proposed) for classifying FOG. A "Category i substance is a POC as determined from human data, two separate mammal studies, or one mammal study with positive results from "short-term" (in vitro) or "site of injeotion/implantation" testa.' A "Category II" substance is a FOG where data is from only one mammalian species or is "suggestive". Priorities " Tentative classification, based on "brief scientific review" may place a Bubstance on a "candidate list" for Category I or II. From each candidate list a "priority list" of approximately 10 chemical materials will be determined (not necessarily by a scientific process). Some of the elements of decision-making will Include number of workers exposed, level of exposure, level of exposure reported to cause cancer, potential of regulation to decrease risk, and availability of substitutes. OSHA states that candidate and priority lists shall not be subject to legal review. Candidate lists phaii be published at least annually and priority lists at least semi annually. . 8003 0892 SCF-FORD-1796 HFM - 004475 Ho. 4l -2- January 31, 1980 Although OSHA will "consider" negative solentlfle data, relatively ma.rgtwny positive data will outweigh all but the most extensive negative test results. Jtalefflaklng Notification (within 30 days) of the Btudy of economic and/or feasibility of specific standards will be given by OSHA. Proposed rulemaking will be in accordance with authority granted to OSHA In the OSHA Act of 1970 and will Include notices of proposed rulemaking, comment periods, and hearing dates. For Category I POC's, controls will provide for the "lowest feasible exposure level" or "zero" exposure if appropriate substitutes are available. Bnergenoy temporary standards may be Issued far Category I POC's where "grave danger" Is determined, as defined In the 1970 Act. For Category II POC's, exposure shall be reduced "as appropriate". Exposure control shall be primarily by means of engineering and/or work-practice controls, and standards for either Category I or II POC's shall follow appropriate detailed "model standards" addressed In the policy. Discussion During Rulemaking Discussion during rulemaking will be limited to certain* issues including; Whether a substance meets a Category I or II POC definition. Whether data are applicable for POC classification or applicable for exception or amendment. - . The environmental impact of proposed regulations. . Determination of lowest feasible/approprlate exposure limit for Category 1/ Category X POC's respectively. --~ ' As more detailed information becomes available related to specific regulations of specific chemicals, the Information and any action plans will be distributed as appropriate. For a full copy of the regulatory text (Title 29 CFR, Part 1990) see Federal Register. Volume 45, Number 19, Tuesday, January 22, 1980, Rules and Regulations, Book 2. Limited copies are available If necessary from the Industrial Hygiene & Toxicology Department (32-20210). - HFM - 004476 8003 0893