Document N2eOqoYkypX9EZr9vwOnoJEGR

Cleary, Gottlieb, Steen a Hamilton I2SO CONNECTICUT AVENUE, N. W. WASHINGTON, O. C. 2 003 6 noil tatoooo August 28, 1979 MEMORANDUM FOR AIHC Re: Status Resort This memorandum will describe briefly and indicate the status of proposed regulations, reports ar.c pending legislation designed to identify and control substances which present a human carcinogenic risk or risk of other chronic health effects. The memo will refer to generic proposals to deal with chronic health effects as distinguished from regulation of a particular substance, e.g. saccharin. The changes from the June status report will be identified by a line in the margin. A. Interacer.cv Orcanlzatior.s I. Reculatcry Council. In October 1973 the President created the Regulatory Council composed of departments and agencies with regulatory functions. The purpose of the Council was to manage the regulatory process more effectively. The first act of the Council was to publish a calendar of Federal Regulations, 44 Fed. F.ec. 11383 , February 23 , 1979. In June the Council announced that the President had asked the Council to develop a national policy framework for car cinogen regulation. The Council is cooperating with the IRLG CAP CO JEN 0011153 agencies in preparing that national policy/ building on the IRLG Report. A status report to the President originally due July 31st has been extended with real due date unknown. The Council is also preparing a manual for benefit analysis, emphasizing health safety and environmental regulation. The Council is also studying cost analysis and consider ing whether some central source of information on governs ental cost analysis should be established. Finally, the Council will endeavor to identify alterna tives to the traditional regulatory process. II. IRIG 1. The Inter Agency Regulatory liaison Group {IRLG) mace up of OSKA, ERA, FDA, CFC5 and (recently added) the Depart ment of Agriculture. On February 6, 1979 Douglas Costle as Chair man of the Regulatory Council established by the President, released an IRLG Report which described the scientific bases for the agencies tc use in determining whether a substance presents a carcinogenic risk. The report covers both the methodology for determining whether there is a cualitative cancer risk as well as the method for cuar.tifyinc the risk. Status. The IRLG Report has been submitted to the Journal of the National Cancer Institute and is expected to be published as a supplement to the July issue of the Journal when peer review is complete. When the report was first released, three agencies (FPA, FDA and C?SC) said they would jointly or severally publish the Report in the Federal Register for comment. CSKA said it would CAP CO JEN 0011154 not join in such a publication for comment because the issues had been addressed in the hearing on the generic cancer policy. The Report was published .for comment on July 6, 1979, 44 Fed. Reg. 39858. Comments are due September 30, 1979. The AIHC Scientific/Alternatives Committees have com pleted a draft of comment for review on the Report. That draft comment has been circulated to members for review and has been widely distributed to association members, government agencies and scientists in academic institutions. The IRLG Report methodology was used by SPA in proposing proposed water quality criteria for priority pollutants. C?SC has also announced its intention to use the IP.IG Report. III. Toxic Substances Stratecv Grous 1. The President created this group made up of the regulatory agencies and research agencies anc chaired by C3Q to advise the President on strategies for control of toxic substances. Cne of its tasks was to develop a national cancer policy. The deadline for the publication of that national policy was December 31, 1978. Status. Earlier this month the Council on Environmental Quality released a Report to the President by the Toxic Substances Strategy Committee on cancer policy. Comments are due September 30, 1979. The AKIC Scientific Committee is preparing comments. 3. Regulatory Agencies IV. OSHA 1. On October 4, 1977, CSHA released its proposed generic regulation for control of exposure to substances presenting a -3- CAPCO JEN 0011155 potential occupational carcinogenic risk. (42 Fed. Reg. 54148). That proposed regulation would establish criteria to determine whether a substance presented a carcinogenic risk and, depending on the category in which the substance was placed in the scheme, would also determine what the regulatory response would be. Status. The hearing record closed on September 15,1978. In the calendar of regulations published by the Regulatory Council the date for publication of a final regulation was given as May 1979. Informal indications are that a draft of the regulation (and preamble) is being circulated for review within the agency. The 3NA Environmental Reporter recently published a story indicating that Or. 3ingham has fixed early September as the publication date. Further checking indicates that the earliest likely data for publi cation is late Seotember or October. Related Information. In 1978 the Fifth Circuit Court of Appeals set aside the benzene standard established by OSEA, American Petroleum Institute v. CSHA, S3I F.2d 493 (1973) The Supreme Court has granted certiorari in that case and has slCrSSC to review two questions. (1) Whether OSHA is required to find that.the costs of the regulation are reasonably justified by the benefits; (2) Whether OSHA may rely on "old" evidence when new evidence is readily available to the agency. The benzene case has been set ccwn for argument in October ecision is expected in January/February 1980. -4- CAPCO JEN 0011156 V. FDA 1. On March 20, 1979 the Food and Drug Administration issued a proposed rule under the so-called DES Proviso to the Delaney Clause (44 Fed. Reg. 17070). The regulations establish criteria and procedures for evaluating residues from animal drugs or food additives found in meat and food products produced by animals (e.g. eggs). The preamble to the regulation describes the criteria for the determination whether the residue substance is a carcinogen under the Delaney Clause. The Commissioner also gives the reasons why he has decided to abandon the Mantel-Bryan mathematical model for extrapolation to low coses and to adopt in its place the much more conservative linear-thrcugh-zero model of extrapolation. FDA also explains .why a lifetime, risk of 1 in a million calculated by that model imposes no additional cancer risk to man. Status. There was a hearing on June 21 and 22, 1979 which consisted of four panels to discuss particular scientific subjects. AIHC was represented on three of the panels. The Society of the Plastics Industry, Inc. and the Animal.. Health Institute were also participants at the hearing. On August 4 there was an informal hearing at which Dr. Robert A. Neal of Vanderbilt testified as a witness offered by AIHC (Dr. Neal had been unable to appear at the June hearing). Comments on the proposed regulation- are due September 4, 1979. Draft AIHC comments have been circulated to the Hoard, the Scientific Committee and the legal Committee. CAP CO JEN 0011157 Additional Information. On March 20, 1979, FDA an nounced the availability of a "Draft Guideline Describing Decisionmaking Criteria used by the Bureau of Drugs When a Member of a Class of Drugs Used in Humans is Determined to be a Known or Possible Carcinogen in Humans or Animals." In an interlocutory decision in the cyclamate case Commissioner Donald Kennedy on June 26, 1979 (his last day in office) sent the case back to the law judge to consider the criteria for determining whether an animal test was positive or negative. He suggested the law jucce consider dual criteria: 99% confidence level .for a necarive test and 90% confidence level for a positive result. Copies of this interlocutory de cision have been sent to the Board, the Scientific Committee and the Decal Committee. VI. SPA 1. 304 of the Federal Clean Water Act. On March 15, 1979, SPA published for comment 27 proposed water quality criteria under 304. The criteria cover 27 of the substances identified as "priority" pollutants in the decree entered into by SPA in the NRDC case. The criteria will be used by the States in fixing water quality criteria (or by SPA if the States fail to act) . Water quality criteria when effective supplant permit limits. The proposed criteria cover both risk to acquatic life and human heaich risk. The preamble sets out methodology for determining human health risk qualitatively and quantitatively. The IP.1G methodology was used. -3 -- CAP CO JEN 0011158 t Status. Comments were due June 13, 1979. (44 Fed. Reo. 23570, April 20, 1979). AIHC filed comments on June 13, 1979. Since June additional criteria have been issues. CMA is talcing the lead in reviewing and commenting on these criteria. 2. 5112 of the Clean Air Act. For over a year EPA has been working on regulations to identify and control hazardous pollutants under $112. In July SPA released a prepublication draft of its plan for control of substances presenting a carcinogenic hazard, SPA's regulatory plan induces the following three elements: U) The Interim Procedures and- Guidelines for Determining Eealth Risk of Suspected Carcinogent. 41 Fed. Fee. 21402, May 25, 1576. (2) A Proposed Regulation establishing the criteria and SPA's Proposed Procedure for Identifying and Listing a Substance Presenting a Potential Cancer Risk as a Hazardous.Substance Under 112. (3) An advanced notice of proposed rulemaking setting forth a Generic Work Practices Standard Applicable to Volatile Organics for Control of Fugitive Leaks and Spills. This generic work practice would be proposed as a rule whenever a substance is listed under 5112. EPA is under a court order in a suit brought by EOF to publish these regulatons and the deadline has passed. EPA earlier released the generic work practices standard and AIHC has testi fied on that subject. Status. By letter dated August 6, 1979 AIHC objected to the proposed regulation and requesting a meeting with Administra tor Ccstia. A meeting with officials from rt? has been arranged for September. Mo date has yet been fixed for a meeting with Costle. CAPCO JEN 0011159 i Publication of the proposed regulation is uncertain and appears unlikely in the next 60 days. ED? in an effort to speed the regulation has sent a letter to EPA announcing its dissatisfaction with the delay on the cancer policy and its intention to reopen the suit to compel a decision on r.ew vinyl regulatons. These regulations are expected to be very important and AIHC will take a very active role. 3. Testing Guidelines. On August 22, 1973, EPA published proposed test guidelines for registering pesticides under FIFPA, including guidelines for mutagenicity tests. 43 Ped. Pec. 37336. On May 9, 1979, EPA pubiiished proposed Good Laboratory Practice Standards for Health Effects under 7SCA rules. 44 Fed. Reg. 27334. On July 26, 1979, SPA published proposed Health Effect Test Standards for TSCA Test Pules, in ducing standards for mutagenicity. 44 Fed. Pec. 44054. Status. In the July 1979 publication EPA in effect solicited comments on all three documents. Comments are due October 15, 1979. A public "meeting" will be held in Chicago on October 15th and loth. CMA is taking the lead in commenting on the test stand ards and C-.L.P. standards. Thp AIHC Mutagenicity Task Group is preparing comments on mutagenicity test standards which will be incorporated in the CMA comments. 4. PCPA. On December 13,1973, EPA published Proposed Guidelines and Peculations dealing with hazardous wastes uri.cer the Solid Waste Disposal law (43 Fed. Pec. 5394S). This far -3- CAPCO JEN 0011160 reaching regulation establishes criteria for identifying hazardous wastes/ a licensing plan for generators/ transporters and disposers of the wastes. The regulation would create an intricate system of record keeping, supervision of waste disposal, and financial responsibility of owners of disposal facilities. This regulation if adopted in its present form could be one of the most expensive and disruptive regulations issued by E?A. Status. One part of the SPA proposal is ar. advanced notice of rule making under 3001 of the statute on the criteria for designating a substance as a hazardous waste. One of the criteria is toxicity of the waste and the substances identified relate to drinking water quality criteria. The comment period expired July 1, iS79. However, SPA received a large number of comments and opened the comment period for comment on the comments. The comments have not been published and must be inspected at SPA. AIHC has not yet decided to submit a comment on the comments. VII. CPSC 1. On June 13, 1978, Consumer Products Safety Com mission published its proposed statement of policy and procedure for evaluating and regulating carcinogens in consumer products. (43 Fed. Sec. 25533). The orooosal was a scheme with categoriza tion of potential carcinogens patterned on the OSHA , rcccsal. Status. The CPSC proposal was enjoined by the District Court. The aoceal by CPSC (Sew Chemical v. Consumer Products Safety Ccrrjr.ission, 439 F.Supp. 373 (W.D.La. 1978), a: seal docketed CAP CO JEN 0011161 No. 78-1166 (5th Cir. Nov. 24, 1978).) has been dismissed. On April 23, 1979 CPSC withdrew its policy statement and announced that it will join with. SPA and FDA in publishing the IRLG Risk Assessment paper for comment. C. Proposed Lecislation VIII. The Wampler bill, H.R. 2982. There are a number of bills pending on specific sub stances alleged to be carcinogenic, e.g. nitrites and saccharin. One bill, however, deals more generally with carcinogenesis. Last term Congressman Wampler introduced a bill which would have directed the NAS to undertake to prepare a state-cf-fhe-art state ment defining and deternini.ng human carcinogenic risk. The bill has been re--introduced and hearings are expected. IX. Reculatcrv Reform. There are a large number of bills on regulatory reform, i.ncludsing one proposed by the President (S. 755) . Hearings have been held by the Senate Governmental Affairs Committee cr, regulatory reform. Jackson Browning, representing AIHC-, -testified before the Governmental Affairs Commictee and the Senate Judiciary Subcommittee. The main points covered in tire AIHC testimony are: (1) Should the regulatory analysis guide agency rulemaking. AI.-C supports the view that the statute requires that the costs cf the rule be reasonably related to the benefits it will produce. (2) Should there be review cf the agency's com pliance with regulatory analysis requirements, AIHC favors executive review and limited judicial review. -10- CAPCO JEN 0011162 4 (3) AIHC proposes that the bill distinguish between the scientific function of risk assessment and the regulatory function of de ciding what regulation, if any, is required. A1KC will recommend the formation of an inde pendent scientific panel to perform the scientific risk assessment. AIHC's testimony underscored also the need for a national cancer policy. The Government Affairs Committee and the Judiciary Com mittee have joint jurisdiction over regulatory reform proposals. Both Committees are expected to reach mark-up after Labor Day and!, both Committees are targeting to finish by October 1st. Dates for Senate action are not fixed. Senate floor action on regulatory reform this year is considered to be likely. The House is not very far along in its consideration of regulatory reform and no forecast of dates of House action is possible at this time. Robert C. Barnard -11- CAPCO JEN 0011163 REPLY FORM TO: Mr. Ronald A. Lang Executive Director American Industrial Health Council 1075 Central Park Avenue Scarsdale, New York 10583 Our Company hereby applies for membership in the American Industrial Health Council based on the dues schedule of $25 per million dollars of corporate sales {minimum dues $250 and maximum dues $25,000). Our total corporate sales (for dues purposes) in our last complete fiscal year were $ - million. (It is not necessary to report less than $10-million or more than $l-bi1 lion.) Our annual dues will be $. Please send us an invoice for this amount. Our designated contact to AIHC will be at_____________________________________________ / /Please send him copies of the following documents: AIHC By-Laws Draft of Comments to Inter-Agency Regulatory Liaison Group Legal Brief re OSHA Proposed Cancer Policy Analysis and Memorandum to EPA re Proposed Generic Air Emissions Cancer Policy Testimony re Work Practices Section of EPA Proposed Generic Air Emissions Cancer Policy Testimony, Background re AIHC Work on Regulatory Reform Legislation Latest AIHC Newsletter AIHC Recommended Framework for Identifying and Regulating Carcinogens Position Paper re Need for Independent Scientific Panel //We are considering AIHC membership but need additional information. Please have someone contact the undersigned to discuss this. In the meantime, please send copies of the materials I have checked above. NAME TITLE COMPANY; ______ HATC rn cmjAMf CAPCO JEN 0011164-