‘ CONGRESSIONAL REC H V universivr of Missouri -Columbia LIBRARY OF WW II II ||||||||||l|| IIIIHIIIJIII lllllll llll CONGRESS 010-103940069 CANCER-CAUSING SUBSTANCES (CARCINOGENS) REGULATION: FEDERAL POLICY ISSUE BRIEF NUBER IB79036 AUTHOR: Carr, Geraldine H. science Policy Research Division Hccullough, James 3. Science Policy Research Division THE LIBRARY OF CONGRESS CONGRESSIONAL RESEARCH SERVICE MAJOR ISSUES SYSTEM DATE ORIGINATED gggggzg DATE UPDATED 9_§4g14§_g FOR ADDITIONAL INFORMATION CALL 287-5700 05 O1 CRS- 1 IBU9036 UPDATE-05/01/80 J-\ §§.Q.15_2§l’..I.!l1l_§. The 0.5 .. Congress has enacted a number of laws which now require extensive regulation of cancer-causing substances (carcinogens). In order to implement these laws, several Federal regulatory agencies have proposed policia for the identification and control of carcinogenic substances. There is a need ' ” to resolve such issues as types ‘of tests which must be performed to determine carcinogenicity; interpretations to be placed upon positive and negative test findings; requirements for risk/benefit assessments where applicable; correlations of animal test data with potential human risk; and determination of permissable concentrations in air, water, foods, or other media; and similar complex factors. In their initial attempts to regulate human exposure to carcinogens, the regulatory agencies did not promulgate well-coordinated Federal policies. The wide variety of sources of carcinogens as well as subtle differences in interpretations of legislative requirements contribute to the difficulties in constructing a standard p olicy . The Federal regulatory agencies and the White House are now cooperating in an attempt to construct a generic policy for regulating carcinogens. The Congress also has been concerned with the regulatory agencies‘ implementation of the laws on carcinogenic substances and has directed specific actions to explore the need for changes in legislation. Because of the potential for the widespread impact of any Federal policy for regulating carcinogens on .ustry, and society in general, public interest in this issue has been high. I §A9.§§.1.*.QQE--;l..1!.12.2Q.1.-l§!.-;l.!AL1.$l§ The regulation of cancer-causing sulstances (carcinogens) has evolved into a major issue of concern in public health policy. The issue has been developing for some time and has reached a peak of interest as Federal regulatory agencies attempt to promulgate and redefine policies an-d regulations to implement a series of laws enacted over the past decade. Controversy over earlier laws requiring the regulation of cancer-causing substances, particularly the Food, Drug and Cosmetic Act, adds to the intensity of the problem. Public attention is high since, with the reduction of morbidity and mortality from infectious diseases, cancer has emerged as second in rank on the Nation's list of the five leading causes of death. It is currently the cause of approximately 400 ,O0O deaths per year. Additionally, about one million persons per year will require medical care for this disease. i Cancer affects all ages and societies. In addition there is a great fea:r "of the pain, prolonged illness and possible disfigurement associated with illness and death from this disease. Unlike the public image of heart and circulatory disease, the number one killer, cancer is generally not viewed by the public as a natural process associated with aging. There is a strong fLg ling that cancer can be eliminated. In response to this high level of concern, the Congress has directed the allocation of a considerable portion of the Nation's biomedical resources to the prevention and cure of cancer. The first National Cancer Act was signed into law in August 1937. In 1938, the National Advisory Cancer Council recommended approval of the first CBS- 2 IB79036 UPDATE—O5/O1/80 awards for Federal fellowships in cancer research. In enacting the National CancerAct of 1971, the Congress significantly enlarged the authorities v the National Cancer Institute and the National Institutes of Health (]?.L.. 92-218) . This legislation was viewed as a major expansion / of the national effort to eliminate cancer. In this act, the Congress indicated its finding that: "the inci.dence of cancer is increasing and cancer is the disease which is the major health concern of Americans today." The funding for cancer research at the National Cancer Institute alone is currently approximately $937 million per year, almost double the amount being spent at the National Heart, Lung, and Blood Institute. Passage of the Haguire amendments (P.L.. 95-622) requiring compilation of an annual list, of carcinogens emphasize.s congressional concern with informing the public of those substances that have been determined to be carcinogenic. <.l.ay.1.§;e.§-21:-§aI;<.=e_I_= The primary Federal efforts to reduce the incidence of cancer up until the last 10-15 years have focused on developing an understanding of the biological mechanisms of cancer and more effective care and treatment. While searching for ort in September 1978 indicate that occupational carcinogens may be inducing a much higher level of cancer, "estimates of at least 20 percent appear much more reasonable." In rebuttal to the NIH report, a University of Texas researcher estimated a range of 10-30% attributable to occupational exposure. Illustrating further the difficulties being encountered in identifying the relative importance of the causal agents of cancer, the suggestion has been made that low levels of radiation, in dosages approximating background radiation, may be responsible for a much larger percentage of cancers than originally estimated. For example, the estimates provided in the HEW Draft Interagency Task Force Report on Ionizing Radiation, Feb. 27, 1979, suggests that "background radiation may account for between 50 and 70 percent of all —cancer, instead of the one percent predicted by current assumptions-" Finally, the development of certain cancers has been associated with some additive substances in food (natural arrl man-made substances), and possibly 'i -.h biological factors such as viruses. §3;e.1.t.i§:.i..c.a;-.1Ln2lz§;1.&2-2r9..12le2§‘». Statistics are often considered as accurate presentations of the state of affairs. In this case, the range of differences of opinion on the inc:i.dence of cancer attributable to various factors is extremely important from a policy perspective. In the first place, the range is so great that it is not possible to be certain of the best priorities for action solely on the basis of data on incidence. As may be noted, if radiation effects, as stated in the HEW report, are the cause of 50-70% of all cancers, then the estimates for occupational hazards, smoking, alcoholic consumption, or nutrition and diet, are overestimated in importance. Similarly, if the estimate for occupational incidence is actually at least 20%, rather than 1%, then the concern for regulating occupational causes of cancer should be subjected to different assessments for priority actions. These significant differences in the statistics on correlations between environmental factors such as radiation or occupational chemicals with cancer in human beings have not been overlooked in the debates on priorities in the war on cancer. If the_ major environmental factors are itobacco smoking, alcohol consumption, sunbathing, nutrition and diet, then the regulation of carcinogens as food additives, occupational chemicals, or air pollutants will have a relatively small effect in reducing total cancer incidence as c trasted with the former factors. On the other hand, if nonpersonal factors have the significance claimed by some discussants, a higher priority should be placed on regulating occupational and other similar anthropogenic sources of environmental carcinogens. Questions which are inherent in this debate include: Is it really the cRs- 4 IB'79036 UPDATE-O5/01'/80 consumer's personal responsibility to reduce cancer significantly by altering personal habits? Is the effort to regulate carcinogenic emissions from various industrial processes or similar sources really going to be i effective as the publicris being led tovbelieve by some data? Are the real benefits accessible only through Government. regulation of carcinogens? Is there really a cancer epidemic caused by currently uncontrolled commercial activities or is the high incidence of cancer being reported a result of increased life span and a multiplicity of genetic/biological factors? What is the real incidence of cancer from occupational factors? Where should priorities and responsibility be placed -- on the individual or industry? Since the statistics on the role played by each cause may be regarded as hypothetical, the guestion of how Federal agencies are going to determine the most effective course of action to pursue in controlling carcinogens is a difficult one. The dewelopment of a Federal cancer policy for regulatory purposes will be influenced by the way in which these and other questions are answered. A In order to develop a Federal cancer policy, priorities must be determined. misplaced emphasis could delay control and improvement in the public health, mislead the public as to the potential for decreased incidence of a dreaded disease, produce greater controversy over the nearly one billion dollar budget for the national Cancer Institute, affect. the utilization of the resources of the regulatory agencies, and impact significantly on the Nation's economy. Lsgislatign Despite the apparent inconsistencies in the statistical data, there is general acceptance of the concept that the prevention of cancer is posible and that control of the causes of cancer is the preferred method of prevention. To this end, the Congress has made policy decisions, particularly in the past decade, which have resulted in a series of additional laws giving the Federal Government authority to regulate certain categories of potential cancer-causing substances. Of course, congressional efforts to regulate carcinogens were already evident in the legislative history of earlier laws; for example, the National Cancer Acts cited in this brief, the Radiation Health and Safety Act, and the Food, Drug, and Cosmetic Act with amendments. other legislation such as the Clean Air Act, the Safe Drinking Water Act, the1Federal Insecticide, Fungicide, and Rodenticide Act, and the Resources Conservation Recovery.Act require the regulatory agencies to consider the sources of cancer-causing substances. However, the enatment of the Occupational Safety and Health Act in 1970, the Consumer Product Safety Act in 1972, and the broad-based.legislative requirements of the Toxic Substances Control Act in 1976 significantly highlighted the intentions of the Congress to require-a strong effort to regulate products which result in exposure of the public to carcinogens. The evolution of several regulatory agencies during this same decade, some by Executive reorganization, others specifically established by the Congress, has diversified the regulatory control of similar substances. The regulatory agencies with major responsibilities for implementinn legislation specifically including authorizations for controlling carcinoge. are: the Food and Drug Adninistration, the Occupational Safety and Health Administration, the Environmental Protection Agency and the Consumer Product Safety Commission. some other agencies have authorities affecting decisions on carcinogens, such as the U.S. Department of Agriculture on food inspection, but the former four agencies are currently the center of the CRS- 5 y IB79036 UPDATE-05/01/80 controversy over *the*development of ‘la vgenericv *federal cancer policy.“ Examples of specific authorities in this area include: ( I ‘Section 1109 (c) (3) of the Food, Drug, and cosmefic Act states that: "no additive shall be deemed to be safe if it is found toinduce cancer when ingested by man or animal or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to w induce cancer in man or animal, except..." section '4 (b) (2) (A) of the Toxic Substances Control Act states that: "The health and environmental effects for which standards for the development of test data may be prescribed include carcinogenesis..." section 6(b) (5) of the occupational Safety and Health Act directs "The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extaxt feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health, or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.... Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and ‘of the performance (I desired." OSHA has interpreted this provision to include regulating of health hazards presented by carcinogens. Section 7(a) (1) of the Consumer Product ' Safety Act provides for the setting of standards to protect the public from the A unreasonable risk of injury, illness or death associated with consumer products and section 3(a) of the Federal Hazardous Substances Act directs the protection of the public health and safety from hazards involved in the presence or use of toxic and other hazardous substances in households. Both of these acts have been cited by the Consumer Product Safety Commission as the basis for standards setting and regulation of suspected carcinogenic materials. §e;=.<_=i9.-9en.£9lic.ie§ As a part of the ‘implementation of these laws, draft cancer policy documents have been issued by several agenci.es. Among other points at issue in these policy documents, disagreements have been encountered with the proposals to classify carcinogens as to degree of danger, definitions of cancer, different methodologies for screening and classi.fying large numbers of chemicals, interpretation and selection of appropriate tests. The early draft documents provided some insight into various methods for classifying and evaluating potentially carcinogenic materials. The public reaction to the proposals has been mi.xed and vigorous. Even with the cc( .iderable number of obstacles to overcome, it soon became evident that there would be considerable advantage to a generic Federal policy on cancer-causing substances. The construction of such a policy requires coordination by the several regulatory agencies. Such a policy may even require some modification of the existing legislation to ensure equivalent requirements. ’ CRS- 6 IB79036 UPDATE-05/01/80 The emergence of risk assessment and cost/benefit analysis as concepts fL determining when regulatory action should be taken may further complicate the I issuance of any generic federal cancer policy since all legislation does not require "such steps. In fact, the requirement in the Toxic Substances Control Act that regulators consider the cost of compliance and the social benefits of the actions being contemplated were relatively new concepts in legislation- .u.!i.1=.2u2.<2.I;.12.r2l..I31=.21_:9.9.ti9n.A9.e§1 A draft paper on cancer policy issued February 1979 (an earlier draft policy including "cancer principles" had been circulated in 1976) by the Environmental Protection Agency acknowledges that achieving zero-risk is not a practical or realistic goal, although such standards will be set if no other alternative is possible.‘ Economic and social factors will be taken into consideration in setting standards. A determination of risk levels will be used to establish priorities for regulatory action. §Qr_1§gg;e_I_:_ Pr_gc_1_1_1_<_:1; §a£e21-§9.mni§§i9r.1 In June 1978, the Consumer Product Safety Commission (CPSC) prepared a draft cancer policy. Their preliminary plan called for a four—step procedure on which to regulate carcinogens. After issuance of a court injunction against use of the interim policy, CPSC. reopened the proposal to public comment. when the Interagency. Regulatiory Liaison Group (IRLG) [0SHA, FDA, CPSC, and EPA] issued its draft proposal on Risk Assessment, the Commission, on advice of counsel, withdrew its proposal citing "its duplicative nature." Q<.=.<;1.12a1.:i2.I;;a.l-§2.1§<.e’21-§t.2Q.§§e1.:11...A<1;I.Qi§gating The draft cancer policy which has stimulated the most controversy is that developed by the Occupational Safety and Health Administration in 1976 and published for comment on rulemaking in the Federal Register on Oct. 14, 1977?. This policy is still under evaluation. Debate on appropriate consideration of risks and benefits procedures for determining if a substance causes cancer and the use of economic factors in developing health regulations are key elements of public concern (see Issue Brief 79223, OSHA's Regulation of Possible carcinogens: Harshall V. American Petroleum Institute). Q2he£-§ede.I;a.1.-.I2_e2.el922.<22s§. The development of a generic Federal policy on carcinogens is being affected by other actions as well. In response to a requirement imposed in the 95th Congress (P.L. 95-203) the National Academy of Sciences prepared a report released in March 1979 on the general subject of food safety which addresses principles for reducing public exposure to carcinogenic substances. This report, assigned as a result of the controversy over the regulation of saccharin, considers again the often-debated need for further modification of the Food, Drug, and Cosmetic Act. Public Law 95-623 (5. 2!-I66, the National Institutes of Health Care Research Act) directs the Secretary of HEW to conduct studies to determine the costs of diseases, including cancer, from environmentally related factors. It also requires actions to improve the conduct of epidemiologic studies and the reliability of the statistical data from such studies. The Director of the National Center for Health Statistics and Dthe Head of the Center for Disease Control (both in the Department of Health, Education, and Welfare) are directed to serve as membets of the Task Force on Environmental Cancer and Heart and Lung Disease (established under section #02 of P.L. 95-95). section 262 of P.L. 95-622 requirs the Secretary of HEW to publish cRs- 7 1379035 opnars-.05/o1/so a list of all substances which either are known to be carcinogens or may be anticipated to be carcinogens and to which a significant number of persons residing -in the United States are exposed. This law also requires additional i1 :rmation on activities such as on—going testing and promulgation of standards, as related to potential cancer causing substances. Within the executive branch, a number of coordinating groups have been established to try and improve interagency cooperation on issues such as the development of a Federal policy on carcinogens (and toxic substances generally). As noted by Douglas Costle, EPA Administrator, the Regulatory Council, has a major goal — the development of a national cancer policy. On Sept. 28, 1979, the Council released its cancer policy; it is a policy of principles, not specifics, which is left to be interpreted by each agency. The IRLG will be considering steps to identify and assess the risks from carcinogens and will be coordinating regulatory priorities and actions. , The IRLG has indicated that in some instances a standard approach may not be possible because the regulatory agencies are affected by different statutory “requirements. The IRLG Risk Assessment iorkgroup has published in the Federal Register a broad statement on cancer risk assessment which the agencies can use for the basis of their own policies. This paper "provides a basis for the development .'.. of a common ... policy." The President's Office of Science and Technology Policy released a staff paper "Identification, Characterization, and Control of Potential Human carcinogens: A Framework for Federal Decision-Making" (February 1979). The purpose of this report, "is to stimulate the development of a uniform decision-making framework to assure consistent Federal action...." The report proposes the separation of regulation into two stages: Stage I in Jlving the research to determine carcinogenic risk; and Stage II assessing risks, benefits, and appropriate meals to limit use. The risk/benefit analysis would include all possible factors such as human, social, and economic values. The paper emphasizes the development of Stage I data to include the’ collection of epidemiological data, the conduct of animal tests, interpretations of conflicting data, the basis of use of screening tests, statistical methods of analysis, development of pr:i.orities and similar processes. The Toxic Substances Strategy Committee was created by the President and consists of regulatory and research agencies. Although one of its tasks was to develop a national cancer policy by Dec. 31, 1978, no details on the status of that policy are available. However, in a July draft report, TSSC endorsed the concept of a generic approach to carcinogen control. The committee recommended that regulatory agencies “should explore ... use of generic approaches to the identificatim and assessment of risks .... in streamlining the regulatory process." Thus far in 1979, legislative activities are already indicative of the continuing concern for the cancer policy issue. Congressional hearings have been held to determine whether appropriate research priorities have been es‘ ‘ulished to deal with "environmental" carcinogens. Recent hearings on the NAS food safety report stimulated further discussion of the need to alter the cancer clauses of the Food, Drug, and Cosmetic Act. The Occupational Safety and Health Administration has reported that their generic cancer policy will be finalized by Dec. 15, 1979. At that time OSHA will identify and set priorities for substances subject to regulation. A major effort is being CRS— 8 IB79036 UPDATE-O5/O1/80 continued by various public interest groups, to direct attention to the need for a uniform approach to regulation of carcinogens. some industry a independent groups suggest a possible overemphasis on the significance or occupational carcinogens while other professional and public interest groups are concerned that diversions of attention to personal responsibility for factors such as smoking, alcohol cmsumption, nutrition and diet, may adversely affect the effort to bring under control the exposure to carcinogens which individuals cannot control. This issue is of great significance in public health policies and the attempts to secure an optimum utilization of available resources to reduce the incidence of this disease will continue to receive congressional attention. L§GI§L-A1-'1 E H.R . 12 (Foley) Amends the Federal Food, Drug, and Cosmetic Act to repeal the blanket prohibition against regulations deeming safe any cancer-inducing food additives or color additives in food, drugs, or. cosmetics. Abolishes the advisory committee of experts established to review regulations disapproving color additives as cancer-inducing. Introduced Jan. 1, 1979; referred to Committee on Interstate and Foreign Commerce. H.R . 1819 (satterfield) Broadens discretion of HEW food additives found to induce cancer animals. Introduced Feb. 1, 1979; referred to Committee on Interstate and Foreign Commerce. H.R. 2982 (iiampler et al.) Directs the Administrator of the Environmental Protection Agency to request the National Academy of Sciences to conduct a study concerning standardizing certain tests for determining potential carcinogenicity, and for other purposes. Introduced Mar. 14, 1979; referred jointly to Committees on Agriculture and on Interstate and Foreign Commerce. 11.11. 3023 (Bitter) Requires the Environmental Protection Agency and the Food and Drug Administration to prepare a comparison of risk prior to the promulgation of any rule or regulation. Introduced Mar. 15, 1979; referred jointly to the Committees on Interstate and Foreign Commerce, and Merchant Marine and Fisheries. H.R . 3378 (Hagedorn) Amends the Federal Food, Drug, and Cosmetic Act to delete certain requirements applicable to food additives and color additives. Introduced Apr. 2, 1979; referred to Committee on Interstate and Foreign Commerce. H.R . H939 (Bitter) Directs the Office of Science and Technology Policy, in consultation with appropriate Federal agencies and offices, to establish a Federal mechansitm within such Office to apply and promote the understanding and appreciation of comparative risks in scientific, technological, and related matters and to CRS- 9 IB79036 UPDATE-05/O1/80 assist Federal, State, and local governments, private industry, and the public i_n making intelligent comparisons and evaluations of those risks. I’ ‘roduced July 24, 1979; referred to Committee on Science and Technology. 3. 58.7 (Schveiker et al.) Amends the Federal Food, Drug, and Cosmetic Act to authorize an evaluation of the risks and benefits of certain food additives. Introduced Mar. 8,. 1979; referred to Committee on Human Resources. 5. 1137 (Cochran) Directs the Administrator of the Environmental Protection Agency to request the National Academy of Sciences to conduct a study concerning standardizing certain tests for determining potential carcinogenicity. Introduced may 15, 1979; referred to Committee on Human Resources. §§é_R.l;1!§§ 0.5. Congress. House. vcommittee cn Interstate and Foreign Commerce. Subcommitteeon Health and Environment. Food safety and nutrition amendments of 1978. Hearings, 95th Congress, 2d session, on H.R. 10358, H.R. 42, H.R. 2180, H.R. 3290, H.R. 5173, and H.R. 5361 (and all other identical and similar bills) . July 18-20, 1978. Washington, 0.5. Govt. Print. Off., 1978. 822 p. "Serial no. 95-128" ----— Moratorium on saccharin ban. Hearing, 95th Ccngress, 1st session on H.R. 7753, H.R. 8012 and H.R. 5166. June 27, 1977. Washington, 0.5. Govt. Print. Off., 1977. 143 p. "Serial no. 95-27" ----- Oversight hearings on saccharin ban. Apr. 11, 1979. 96th Congress, 1st session. (Not yet published) ----- Proposed saccharin ban —— oversight. Hearings, 95th Congress, 1st session. Har. 21 and 22, 1977. Washington, 0.5. Govt. Print. Off., 1977. 592 p. "Serial no. 95-8" 0.3. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Oversight and Investigations. Cancer—-causing chemicals--part 1 : safety of cosmetics and hair dyes. Hearings, 95th Congress, 2d session. Washington, 0.5. Govt. Print. Off., 1978, 1464 p. Hearings held Jan. 23 and 26; Feb. 2-3, 1978. "Serial no. 95-91" ----- «Environmental causes of cancer. Hearings, 9t1th Congress, 2d session. Washington, 0.5. Govt. Print. Off ., 1977. 329 p. Hearings held May 28 and Sept. 20, 1976. “Serial no. 94-1H1" 0.5. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry. Subcommittee on Agricultural Research and cns-10 IB79036 upnnTr—b5/01/30 General Legislation. Food safety and quality--nitrites. -Hearings, 95th Congress, 2d session. Part III. Washington, 0.5. Govt. Print. Off., 1978. 364 p. Hearings held Sept. 13-25, 1978. ---- Food Safety and quality: regulation of chemicals in food and agriculture. Hearings, 95th Congress, 1st session. Part I. ,Washington,2 0.5. Govt. Print. Off., 1977. 149 p. Hearings held June 30 and July 19, 1977. 0.5. Congress. Senate. Committee on Human Resources. The banning of saccharin, 1977. Hearing, 95th Congress, 1st session. June 7, 1977. Washington, 0.5. Govt. Print. Off., 1977. 173 p. _ Oversight hearing on the saccharin ban. May 9, 1979, 96th Congress, 1st session. (Not yet published) 0-5. Congress. Senate. Committee on Human Resources. Subcommittee on Health and Scientific Research. National cancer program. 96th Congress, 1st session. Hearings held Har. 5, 1979. [to be published] 0.5. Congress. Senate. Committee on Human Resources. Subcommittee on Labor. Monitoring of industrial workers exposed to carcinogens, 1977. Hearing, 95th Congress, 1st session. Hay 9, 1977. Washington, 0.S. Govt. Print. Off., 1978. 10¢! p. .---— Occupational diseases, 1977. Hearings, 95th Congress, 1st session- June 28-30, 1977. Washington, 0.3. Govt. Print. Off., 1973. 357 p. Brown, Clarence. CaJ.ls for reconsideration of the 1958 Delaney clause in Food, Drug, and Cosmetics Act which prohibits use of any food additive that has been shown to cause cancer; article. Congressional record [daily ed.] v. 125, no. 20, Feb. 22, 1979: B638. 1 Cochran, Thad. Directs EPA and requests National Academy of Sciences to conduct study regarding standardizing test for determining potential carcinogenicity. Congressional record. [daily ed.] v. 125, may 15, 1979: s7uu9. Hansen, George. Discusses projected costs of proposed OSHA regulation to control carcinogenic substances: inserts report. Congressional record [daily ed.] v. 125 June 28, 1979: H5ll1lI. A McGovern, George. Notes importance of "dietary goals" and nutrition education in combating disease, particularly cancer. Congressional record [daily ed .] v. 125, no. 36, Mar. 22, 1979: S3251. obey, David. Inserts FDA report on experiment examining validity of "safety threshold" theories on carcinogens; refers to Hampler, William C. 09/28/79 07/23/79 07/20/79 -- 07/06/79 06/22/79 06/15/79 05/29/79 04/23/79 ‘Commerce 0 CRS- 11 IB79036 UPDATE-05/O1/80 OSHA regulations. Congressional record [daily ed.] Av. 125. July 27, 1979: E3937. Congress. House. Committee an Interstate and Foreign Saccharin ban moratorium; report to accompany H.R. 8518 together with additional views. Washington, 0-5. Govt. Print. Off., 1977. 60 p. (95th Congress, 1st session. House. Report no. 95-658) House. Committee on Interstate and Foreign Subcommittee on Oversight and Investigations. report together with Govt. Print. Off., 1978. Congress . Commerce. Cancer-causing chemicals in food: separate views. Washington, U .S. 103 p. At head of title: 95th Congress, 2d session. Committee print. House. Report no. 95-67. Request for National Academy of Sciences to Study Feasibility of Establishing a Single National Cancer Risk Assessment Policy for Evaluating Carcinogenicity of Substances. Congressional record [daily ed.] v. 125, no. 331, Har. 111, 1979: H13ll2-1344. §§_..R0N0LQ§.Y..Q1.’-fl1.‘»'E.'l.‘§ Regulatory Council released its national cancer policy principles. EPA's Science Advisory Group's Risk Assessment Subgroup met to discuss the IRLG's Risk Assessment Document. Administrative Conference of the United States, Subcommittee on Licenses and Authorization held its first meeting with consultant Richard Merrill on a study of public decision-making in the area of Federal policy for regulating carcinogens. Requests for comments on the IRLG document "Scientific Bases for Identification of Potential Carcinogens and Estimation of their Risks" (uu FR 39859-39879, Part III). FDA public hearings to discuss the agency 's proposal to establish procedures and minimum criteria to ensure the absence of cancer-causing residues in edible products of food-producing animals. The National Center for Toxicological Research announced the results of a mega-mouse study that refutes the concept of threshold dose for carcinogens. Risk Assessment Workgroup of the Interagency Regulatory Liaison Group is dissolved. Consumer Product Safety Commission withdrew its carcinogen policy proposal (I-HI FR 23821-22). 04/15/79 03/30/79 03/20/79 03/08/79 3 03/02/79 02/28/79 02/06/79 02/01/79 02/00/79 01/24/79 01/09/79 12/28/78 CBS— 12 13790 35 UPDATE-Q5/O11/80 Arthur Upton, National Cancer Institute Director cautioned against the use of quantitative risk assessment in regulatory decision-making in a letter to FDA Commissioner, Donald Kennedy. FDA published draft guideline on the decisionmaking criteria used by Bureau of Drugs scientists when a drug used in humans is identified as a known or possible carcinogen (44 FR 19034) . Dr. Reuel Stallones released a critical study of HEW-NIH occupational cancer estimates ccncluding that the full range of occupationally caused cancers may be from 10-33% or perhaps higher. FDA reproposed the Sensitivity of Method regulation dealing with cancer-causing residues in food-producing animals to which drugs and food additivs have been administered. Technology Assessment Board approved project to be undertaken, technologies for determining cancer risks from the environmalt. , National Academy of Sciences Committee an Saccharin and Food Safety releases "Food Safety Policy", Part 2, Scientific and Societal Considerations, prepared in response to P.L. 95-203. American Cancer Society symposium on environmental determinants of cancer relevant to prevaltion. Interagency Regulatory Liaison Group released the report "The Scientific Bases for Identifying Potential carcinogens and Estimating their Risks." EPA internal draft of cancer policy released. Office of science and Technology (OSTP) staff paper on carcinogens released . Report of the Subcommittee on Environmental Carcinogenesis, draft report "The Relation of Bioassay Data on Chemicals to the Assessment of the Risk of carcinogens for humans under conditions of Low Exposure, submitted to the National Cancer Advisory Board." Administrative Law Judge J.F. Greene certified the hearing record for OSHA 's proposed cancer policy. Interagency Regulatory Council Chairman Douglas Costle indicated that the development of a national cancer policy is a goal of the council. Consumer Product Safety Commission reopened the comment period for classifying, evaluating and regulating carcinogens in consumer products (43FR 601136) . 11/00/78 11/05/78 10/11/78 09/28/78 09/15/73 09/14/78 08/30/78 07/2 5/78 07/25/78 o7/1u/73 06/19/78 06/13/78 OS/1 6/78 03/27/78 CRS"13 IB790w36 UPDATE-05/01/80 National Academy of Scia1ces, Committeeon Saccharin and Food Safety Policy released Saccharin: Technical Assessment of Risk and Benefits, Part I, in response to P.L. 95-203. P.L. 95-626 Biomedical Extension Act. National Cancer Advisory Board must have at least five members knowledgeable in the area of environmental and occupational carcinogenesis . Public comment period for CPSC's proposed cancer policy ends. U.S. District Court for Western District of Louisiana enjoined CPSC from using its policy to classify perchloroethylene as a Class A carcinogen (Dow Chemical et al. v. CPSC, no. 781166). HEW Sec. Califano released draft NIH—NIHiS study on Occupational Exposure to carcinogens at the AFL-CIO Health Conference, Washington, D.C. U.S. District Court for western Louisiara restrained the Consumer Product Safety Commission from listing tetrachloroethylene as a Class A carcinogen. Barry P. Bosworth, director of Council on Wage Price and Stability, informed OSHA that its proposed cancer policy had been chosen for scrutiny by the Regulatory Analysis Review Group. OSHA public hearings on generic cancer policy ended. OSHA decided to conduct a regulatory analysis of its proposed carcinogen policy in compliance with Executive Order 12ouu. OSHA issued tentative list of carcinogens for proposed generic policy. Barbara Blum, Deputy Assistant Administrator, EPA, wrote the American Industrial Health Council of the lack of need for National Academy of Sciences panel for evaluating carcinogenic risk estimation procedures. The Consumer Product Safety Commission published in the Federal Register an interim policy and procedure for" classifying, evaluating and regulating carcinogens in consumer products (43 FR 25658). Public hearings on the OSHA cancer policy proposal commenced. Foster D. Snell, contractor for the American Industrial Health Council released an economical impact study demonstrating that OSHA 's policy could cost as much as $88 billion- 03/23/78 02/28/78 01/13/78 01/10/78 11/00/77 10/13/77 10/07/77 10/04/77 09/26/77 07/27/77 05/02/77 02/22/77 01/00/77 06/02/76 05/25/76 CR5-14 IB79036 UPDATE—U5/0?/80 Meeting held by EPA on the need to develop a comprehensive program for regulating carcinogenic air pollutants. Deadline for submission of written commaxts to OSHA 's proposed cancer policy. Over 260 comments were received. American Industrial Health Council (representing over 100 companies and 60 trade organizations) released an 85 page response to OSHA's carcinogen policy proposal. U.S. Chamber of Commerce seminar on OSHA proposed policy for carcinogens in the workplace. The Environmental Defense Ftmd submitted to EPA a petition requesting the establishment of a system of classifying and controlling atmospheric carcinogens. The American Industrial Health Council formed to respond to OSHA 's proposed carcinogen policy. Toxic Substances Strategy Committee held its first meeting to discuss development of a common set of cancer principles. OSHA issued a draft environmental impact statement on the proposed generic cancer policy. The Occupational Safety and Health Administration published a proposed cancer policy in the Federal Register (112 FR 54148-5/4247). Interagency Regulatory Liaison Group formed by Consumer Product Safety Commission, Food and Drug Administration, Environmental Protection Agency, Occupational Safety and Health Administration. Consumer Product Safety Commission staff instructed to develop a policy on carcinogens in consumer products. Society for Occupational and Environmental Health's Conference on the implications of OSHA's proposal on carcinogen regulation held. Food and Drug Administration criteria and procedures for evaluating assays for carcinogenic residues (Federal Register February 22, 1977.: 101112-1Oll37) . The Occupational Safety and Health Administration circulated draft of generic carcinogen policy for comment. National Cancer Advisory Board, Subcommittee on Environmental Carcinogenesis. General Criteria for Assessing the Evidence for Carcinogenicity of Chemical Substances, released. EPA adopted interim cancer assessment procedures CBS-15 IB79036 UPDATE-0 5/0 1/80 "Interim Procedures 8 Guidelines for health risk and _ -9 economic impact assessments of suspected carcinogens. up (Federal Register, May 25, 1976: 211102-21404) A22l2£9.£{.A.L.§§§.§l_1§.1!Q§-§...0UR §§§ Alexander, Tom. 0sHA's ill-conceived crusade against cancer. Fortune. July 3, 1978: 86-90. American Cancer Society annual report 1978: 6. American Industrial Health Council. A proposal to achieve cohesive national cancer policy. may 24, 1978. American Industrial Health Council. A reply to: "lstimates of the fraction of cancer in the United States attributable to occupational factors" (Sept. 15, 1978) Oct. 23, 1978: 13 p. with appendices. ‘ --— Comments and recommendations in response to the Occupational Safety and Health Administration 's proposal for the identification, classification, and regulation of substances posing and occupational risk. Jan. 10, 1978. ---’ Comments and review of the IRIL-‘.'s scientific basesi for identification of potential carcinogens and estimations ( of potential carcinogens and estimations of risk. may 5, 1979. Are 90% of cancers_ preventable? The lancet. Mar. 26, 1977: 685-687. Baldwin, Robert H. Regulating carcinogens--the bitter and the sweet. Chemtech. Mar. 1979: 156-162. Burrows, William E. The cancer safety controversy. The Sunday New York times magazine, liar. 25, 1979: 82-85, 87. Cairns, John. The cancer problem. Scientific american. November 1975: 64-78. H . Can regulators agree on a cancer policy? Chemical week. Feb. 28, 1979: 46. ' Cancer and chemicals-cont., Chemical and engineering news, v. 56, Jan. 30, 1978: 30-35. Carter, Luther J. Dispute over cancer risk quantification. Science, v. 230, Mar. 30, 1979: 132'-I-1325. ---- Yearly report on carcinogens could be a potent weapon in the war on cancer. Science. Feb. 9, 1979: 525-528. v Cooper, Richard H. The role of regulatory agencies in risk-benefit decision-making. Food drug cosmetic law journal. December 1978: 755-773.. Cornfield, Jerome. carcinogenic risk assessment. Science, CBS-16 IB79036 UPDATE-35/G?/80 v. 198. Nov. 18, 1977: 693-699. Decision making for regulating chemicals in the environment. National academy of sciences. National resource council. ‘1975. 232 p. Dickson, David. OSHA defends leap in carcinogen regulation- Nature. may 25, 1978: 260-261. Doll, Richard. Strategy for detection of cancer hazards to man. Nature. Feb. 17, 1977: 589-596. Eisenbud, Herril. Environmental causes of cancer. Environment. October 1978: 6-16. Estimates of the fraction of cancer in the United States related to occupational factors. National Cancer Institute, National Institute of Environmenta1.Health Sciences, National Institute of Occupational Safety and Health. 0.5. Department of Health, Education, and Welfare. Washington. Sept. 15, 1978: 39 p. with appendix. Federal policies for regulating carcinogenic compounds. General accounting office review, v. 11, winter, 1977: 1-9. Food safety policy. Scientific and societal considerations. National Academy of Sciences. Institute of Medicine. March 1979. Franklin, Barbara H. Chemicals 8 camzer: Government SNAFU? Chemical times and trend. April 1978: 20-23. Franklin, Barbara H. and John F. Schmutz. Chemicals and cancer. Chemical and engineering news, v. 56, Jan. 16, 1978: 34-39. Freudenthal, Ralph J. Present-day knowledge and a rational cancer policy. Chemical times and trends. April 1978: 2n-28. Halberstan, Michael J. Cancer and the environment. The Washington post. Jan. 16, 1979. A19. Harlow, Dan. Government's carcinogen policy: sciene or politics. Chemical times and trends. v. 1, April 1978: 16-19; 75-77. Henteleff, Thomas. The Delaney myths. Food drug cosmetic law journal. August 1978: 396-H04. Hutt, Peter Barton. Public policy issues in regulating carcinogens in food. Food drug cosmetic law journal. October 1978: 54 1-577. IARC: Working towards the prevention of cancer. HH chronicle. 32: 1u0—178. (1978). Kirschten, Dick. The new war on cancer-Carter team seeks causes, not cures. National journal. Aug. 6, 1977: 1220-1225. Lowrance, William I. Of acceptable risk. Science and the determination CBS-T7 9 IB79036 UPDATE-05/O1/80 of safety. William Kaufmann, Inc. Los Alton, California. Elartin, James G. Cancer and the Congress. Chemical times and -trends. v. 1, April 1978: 13-15, 7o—7n. -----The Delaney clause and zero risk tolerance. Food drug cosmetic law journal. January 1979: 43-49. uaugh, Thomas H. 11. Chemical carcinogens: The scientific basis for regulation. Science. Sept. 29, 1978: 1200-1205. uccarity, Thomas O. Substantive and procedural discretion in administrative resolution of science policy questions: regulating carcinogens in EPA and OSHA. Georgetown law journal, v. 67, February 1979: 729-810. Office of Science and Technology Policy. Identification, characterization, and control of potential human carcinogens: A framework for federal decision-making. A staff paper. Feb. 1, 1979: 35 p. Principles for evaluating chemicals in the environment. National academy of sciences. National resource council- 1975. #54 p. Rothschild, Nathaniel H.V. Coming to grips with risk. The Wall street journal. Mar. 13, 1979: 22. “award, Ernest, and Andrew sorensen. The current emphasis on preventive medicine. Science. May 26, 1978: 889-8914. scientific bases for identifying potential carcinogens and estimating their risks. Interagency regulatory liaison group. Washington. Feb. 6, 1979. 113 p. Smith, R. Jeffrey. Cancer policy announced. Science. Oct. 19, 1979: 313. ---- OSHA carcinogen policy delayed. Science. Jan. 5, 1979: 35. Subcommittee on Environmental Carcinogenesis, National Cancer Advisory Board. "The relation of bioassay data on chemicals to the assessment of the risk of carcinogens fa: humans under condition of low exposure," draft report, February 1978. 6:} ---------- The relation of bioassay data on chemicals to the assessment of the risk of carcinogens for humans under conditions of low exposure draft report of the SIC on environmental carcinogensis to the National Cancer Advisory Board. February 1979. The saccharinydebate: regulation aid the public taste. Hasting center report, v. 7, December 1977:‘ 5-7. \‘1"he toxic environment is everybody's business. The Center magazine. Hay/June 1978 : 76-80 . 8.5. General Accounting Office. Federal efforts to protect CRS-18 IB79036 UPDAE-05/01/80 the public from cancer-causing chemicals are not very effective; report to Congress by the Comptroller General of the United states. Washington, 1976. 57 p. U.S. Library of Congress. Congressional Research Service. American Law Division. OSHA 's regulation of pcssible carcinogens: Marshall v. American Petroleum Institute [by]: Donna Pratt. [Washington] 1979. Archived Issue Brief 79223. what proportion of cancers are related to occupation? The lancet. Dec. 9, 1978: 1238-12fl0. iildavsky, Aaron. No risk is the highest risk of all. American scientist. January—February 1979: 32-37. workplace cancers: politics v. sciaace. Environmental science and technology. January 1979: 15-18. iynder, Ernst L. Cancer prevention: a question of priorities. Nature. July 28, 1977: 284. Jun‘.-._.__ I-....,,__,‘.‘ _..h‘l.~ \‘*?-:u:a--cru_.i.d ' OF 3 J-«-—«— :2 . UN? ‘v’E‘:%su"3"2.r ST; muers - M3, . K-~ .— —--_.......I