NB lfOlTl. me UHCIGSSIHBOII UGCIESSITIGO 0! [he Nauonal AFCHIVBS xx? x? Of?ce of the Assistant Secretary Occupational Safety and Health Administration wasamerow, no. 10210 i :2 .1 a eff?7% lei-?13? @333 if"? .r a MEMORANDUM FOR: RAY SECRETARY OF LABOR EULA BINGH we" FROM: ASSISTANT SE E- FOR S/(l AFETF AND HEALTH I ljfx: f? SUBJECT: OSHA'sVCancer Policy PRIORITY: Top Priority SUMMARY The OSHA cancer policy will be the first regulation issued as a result of the effort begun in early 1977 by the Carter Administration to develop a coordinated and consistent approach tx) government regulation of cancer causing substances. OSHA has been the catalyst for this effort, and this cancer policy is supported by and concurred in by the other major regulatory agencies and the research agencies. The Cancer Policy has three major objectives-? . to resolve the scientific issues identification of substances that pose a cancer risk to workers. It does so consistent with principles established by the IRLG and with the Regulatory Council's national cancer policy. involving . to establish a framework for classifying carcinogens based on the nature and extent of the scientific evidence of their cancer?causing potential. This classification system is the ma'or element of a standards?setting priorities system that will guide be available for future agency regulatory action and the public to scrutinize? -2- . to provide guidelines (model standards) for regulating substances identified and classified (prioritized) as posing a cancer risk to workers. These guidelines inform the public as to the general approach of the agency's future standard?setting activity for potential and suspect cancer-causing agents. The Cancer Policy brings to the regulatory process a systematic approach to regulatory action1 makes public in a formal manner the bases that will underlie agency action and establishes a system for determining priorities and guidelines for future regulatory activities. It is now estimated by HEW that from of all cancers in the U.S. (400,000 per year from all causes) are associated with occupational exposures to cancer causing substances. The OSHA Cancer Policy establishes a system for the identification, classification and regulation of substances which pose a cancer risk in the workplace. The policy is intended to improve and simplify the development of standards to prevent or reduce My employee exposures to such substances. The policy describes the scientific basis for identifying cancer causing substances and defines criteria. for using available scientific data to classify these substances. Regulatory action will be based on this classification system. Confirmed cancer-causing substances will be classified as suspect . cancer?causing substances a category substances which have not been shown to cause cancer as category and substances a 4.: -3- which are not found in the U.S. as category IV. The policy thus establishes a framework for determining priorities for w? regulatoryp_action: OSHA will regulate the: ?worst substances first", after considering many factors, such as number of employees exposed, present levels of exposure and apparent potency. The policy also contains model standards for confirmed and suspect carcinogens (category' I and II) which will serve as guidelines in issuing future standards for substances in these categories. Background/Statement of Issues In October 1977, OSHA published a1 proposed Cancer Policy. Extensive public hearings were held in May, June and July of 1978. Over 200 representatives from employer associations, emplOyers, unions, public interest groups and the government appeared. Written comments were also extensive. The record is over 250,000 pageso OSHA's Cancer Policy is fully consistent with the Regulatory Council's National Cancer Policy" which is to be issued this Friday. 1. Why do we need a cancer policy? It is estimated that up to of all cancer in the U.S. per year from all causes) are associated with occupational exposures. In the past, OSHA has dealt with carcinogens on a substance by substance basis, in effect looking primarily at only one piece of a large puzzle. The same issues were debated time and time again during the standard-setting process. The Cancer Policy is an attempt to establish a system for rationally dealing with the many substances that have been implicated as potential carcinogens. OSHA also believes this system may streamline the regulatory process. First, it establishes criteria for determining whether a substance really does present a cancer risk to workers; it lets the public know the facts and criteria that are considered in setting agency priorities; and it provides guidelines on what requirements may be established for carcinogenic substances. 2. Identification of Potential Carcinogens Substances that are found to be carcinogenic in humans or animals will be treated as workplace carcinogens. The scientific criteria set forth in the cancer policy and preamble will be used to determine whether the substances have in fact been scientifically shown to cause cancer in animals or humans. These scientific criteria are fully' consistent with the Interagency Regulatory Liaison Group (composed of EPA, CPSC, FDA, FSQS and OSHA) document entitled Scientific Bases for Identification of Potention Carcinogens and Estimation of Risk. -5- 3. How does the Cancer Policy Operate? A. Priorities Evidence received. by' OSHA. public petitions or other sources which implicates a substance as El potential carcinogen will be reviewed by OSHA. Other readily available sources will also be reviewed. Applying the criteria contained in the policy, OSHA will: deny the petition; refer the petition to HEW for scientific review; or place the substance on the "General List". The "General List" is a list of those substances which are present in U.S. workplaces and are preliminarygj?giewed as possible confirmed or suspected carcinogens. Substances on the "General List" will then be studied to estimate exposure levels, number of employees, apparent potency and to consider other factors relevant in setting priorities. OSHA would then review available evidence on the highest priority substances more thoroughly and choose which substances to regulate first. The general list and the priority list will be updated periodically to let the public know the factors considered by OSHA in setting priorities. -6- B. The Rulemaking Proceeding OSHA will then issue :1 proposal for the highest priority substance or substances. 1/ The proceeding will focus on the technical and economic feasibility of the proposal; whether the studies that implicated the substances in question were well-conducted; and in specified limited circumstances whether exceptions to certain provisions of the policy exist with respect to the substance in question. A few well-established principles will not be reconsidered in proceedings on individual substances. For example, substances which cause cancer in mammalian species will be treated as workplace carcinogens; it is assumed that no safe level of exposure to carcinogens can be established; employers must reach the 1/ An Emergency Temporary Standard (ETS) could also sometimes be issued where OSHA believes that immediate regulatima is urgently needed to protect employees. The ETS would remain in effect for up to six months and would require what it achievable through any practicable combination of engineering controls, work practice controls and respirators. 2/ The appropriate forum for challenging any general principle of the cancer policy is to file a petition to amend the policy. The policy recognizes that major scientific breakthroughs are possible and encourages petitions to amend the policy in those circumstances. -7- "lowest feasible level; and engineering controls and work practice controls, rather than respirators are the primary method of complying with the standards. C. Classification and Model Standards (1) Category I Substances Substances that are found to be confirmed carcinogens will be classified as category 12 substances. Model standards will serve as guidelines for most provisions in issuing proposed and final standards for each substance. However, the general policy of OSHA will be to presume that the "types" of requirements found in these model standards are to be required, except where circumstances so warrant. The final requirements in the standard will, of course, be based upon the record in the proceeding. Thus, it is anticipated that category I substances will generally contain notification of use, monitoring, permissible exposure limits, medical surveillance, signs and labels, training and the other typical provisions of OSHA health standards. (2) Category II Substances. Substances that are found to be suspected carcinogens will be classified as category II substances. Minimal requirements will be imposed, using the category II model standard as a -8- guideline. Thus, notification of use monitoring, medical surveillance and simple inexpensive housekeeping requirements will generally be imposed. (3) Category Substances Substances that are not found to be confirmed or suspected carcinogens will be placed in category No rulemaking proceedings under the Cancer Policy will be? instituted for category substances. (N) Category IV substances Substances.that are not found in U.S. workplaces will be placed in category IV. No rulemaking proceedings under the cancer policy will be instituted for category IV substances. Major Issues a. Should OSHA perform risk asSessments? Everyone agrees that where the data are adequate, some form of risk assessment should be performed. Where human studies are used, they may provide enough information to determine the upper bound of risk. Animal data, however, are far more difficult to utilize for reliably extrapolating quantitatively the risk to workers. Industry witness recognized these quantitative extrapolations are, at best, crude, but argued that performing quantitative risk assessments from animal data -9- is better than "doing nothing". The Cancer Policy deals with this by pointing out the pitfalls of such extrapolations and indicating that where the data are sufficient to reliably quantify risk, OSHA will do so. The sole purpose of the risk assessment is to determine health need. It would not be used to perform a cost-benefit analysis. b. Should OSHA create a non-Government panel to scientifically review evidence? Industry suggested at the hearings that OSHA create a non-Government panel composed of scientists from diverse groups, including industry to determine which substances should be regulated as carcinogenic, and to quantify the risk. Its avowed purpose is to get the scientific issues out of the "political arena" of OSHA. The Cancer Policy does provide for an independent scientific panel of governmental scientists chosen by the Secretary of HEW convened at the Secretary of Labor's request. 0. Does the OSHA Cancer Policy "Freeze Science"? Industry witnesses argued that by establishing a policy and foreclosing certain issues, OSHA will not be able to keep pace with the ever-changing' science of cancer. It is clear that OSHA must keep pace with science in order to rationally regulate workplace carcinogens, and the final Cancer Policy will permit OSHA to adapt and respond to scientific developments. First, most scientific issues are not foreclosed, and therefore will permit consideration of real scientific advances. With respect to those few issues that are foreclosed, only' major unanticipated scientific breakthroughs would change these long established scientific principles. If such a breakthrough does occur, then OSHA will amend the Cancer Policy. In fact, the Policy itself encourages petitions to amend the Policy in such circumstances. d. Whether Carcinogens should automatically be regulated? The proposal provided for automatic issuance of an Emergency Temporary Standard (ETS) and various other mandatory steps culminating in the automatic regulation of all workplace carcinogens within a specified time-frame. The Unions favored this process. Industry did not. The final Cancer Policy does not contain the above requirements. Although may be issued for carcinogens, there is a serious legal question as to whether may Under the Act, ETS's may be issued without any rulemaking proceeding if a grave danger exists and emergency action is needed to protect employees. They remain in effect for 6 months. -11- automatically be required in the Cancer Policy. In addition, mandatory ETS's do not provide the flexibility to utilize resources most efficiently. Resources will continue to be utilized for ETS's where appropriate, but OSHA may also issue standards under the policy without issuing ETS's. With respect to automatic regulation of workplace carcinogens within certain timeframes, the agency has concluded that a more effective approach is to regulate the "worst hazards" first in a rational priority system. Thus, OSHA will be able to regulate carcinogens on a "worst first" basis, and integrate carcinogen priorities with other OSHA standard-setting priorities. e. Should OSHA have performed an economic impact study? OSHA did not perform an economic impact study of the proposal because it was impossible to estimate which substance would be regulated; when they would be regulated; what the specific regulatory requirements would be, including the permissible level of exposure; and how much individual standards would cost. Industry attempted to perform such a study, but many, including CWPS, agree their attempt was wholly inadequate, in major part because of the speculative nature of -12- the study due to the above factors. It also grossly exaggerated the potential costs. OSHA did, however, perform a Regulatory Analysis of the a?awViHri OSHA believes that an economic impact study would not be appropriate. All of the reasons that led to not performing such a study still apply. There is also one other important reason: Under the proposal, OSHA was supposed to automatically issue standards within certain time frames, therefore every substance would be regulated. Because of the agency's decision to establish a rational system for priorities in the final cancer policy, however, not every carcinogenic substance will be regulated in the foreseeable future. As a result, an estimate of the economic impact of the Cancer Policy would be even more speculative than at the time of the original proposal. f. How does the final Cancer Policy differ from the proposed cancer policy. While the scientific criteria in the final Cancer Policy are unchanged, some of the regulatory provisions do differ. First, unlike the proposal, the final contains ea system :for setting priorities. In addition, the proposed requirement to issue a standard automaticaly has been deleted, as well as the -13- requirement to issue standards within prescribed timeframes. Also, the proposed binding model standards have been changed to guidelines. Other DOL Agencies Involved The Solicitor's Office has reviewed this ?memorandum and concurs. ASPER revifnv will take place before the policy is issued. Other Federal Agencies Involved The IRLG Agencies (CPS, EPA, FDA) have carefully reviewed the Cancer Policy and concur. The final document will be cleared through them. In addition, personnel from the research institutes CNCI, NIOSH, NIEHS) have been deeply involved, including the Director of each Institute. Congressional Interest Sy Lazarus has indicated that concurrence of the Regulatory Agencies ?will obviate the need for clearance with the White House Domestic Staff. Before issuance, the appropriate persons in DOL will be contacted to make the necessary Congressional contacts. Senator Eagleton and Congressman Maguire have been following ?the development of the policy. Congressman George Hansen and Congressman Jinn Martin. have been critical of the proposed policy.