Document 4vn5oV634bGqeoKrwj0kJXxLx

INF ATION COPY WILLIAM J. DRIVER PRESIDENT MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N. W WASHINGTON. D. C. 20008 (2021 485-6126 ,,bjC/^'i/^*' 1/ 72' U & October 21, 1977 RECSiVEO 'CCT 2 C *,f7 j. E. To the Executive Contacts of MCA Member Firms Dear Sirs: Subject: OSHA Cancer policy A proposal for the regulation of generic carcinogens was published by OSHA in the October 4th Federal Register* Briefly, it is proposed to establish criteria for classifying materials as (1) carcinogens (2) suspect carcinogens (3) all other material or (4) carcinogens not found in the workplace. Rigid reg ulatory responses would be required in each case. An emergency temporary standard and proposed standard, both specifying lowest fea sible exposure,would result from placing a material in the first category. Also in that case, no occupational exposure would be allowed if the Secretary of Labor determines a less hazardous substitute is available for certain uses. For substances in the second category, a standard would be promulgated or revised, if one exists, with an "appropriate" permissible exposure level to protect against acute or chronic effects of exposure. Model standards are provided for each of the above instances. Placement in the last two categories would result primarily in the exchange of information on these substances with other agencies. This regulatory approach allows no flexibility to reflect different degrees of hazard, lacks suifiMguidelines for_acceptabilttv_pf toxicologi.cal~data and fails to provide procedural safeguards before banning materials, other aspects of the proposal of concern are the assumed OSHA doctrine that no safe level of exposure exists for car cinogens and the establishment of specification standards rather than performance standards. The Board of Directors concurred in a plan proposed by the Synthetic Organic chemicaT Manufacturers Association to form an_ad hoc industry* task force'under whose^direction.J'l') T rec.ptd_pf__t_estimony would be -*> prepared siicTPThat it would be adequate_in tfrq event of future_cour_t,_ review^ (21 desired changes in the _propp$ed_reula'tion"vould be iden tified and .recommended. _T5T OSHA would be encouraged to make an. econora- ic impact analysis, and (4) other industry"'and non-Indus try groups would be enlisted for suppor~of the"* position taken. Mr. Paul F. Oreffice, AP00047960 2 president of Dow Chemical U.S.A. and a member of MCA'^Executive Committee and-Board--will-lead .this effort, It. is Likely_one of' the_first--steps-will~be._to_.reque>t a delay in OSHA's present deadlines of December_8 jLoc^initial comments, January 9 for a more comp 1ete record and March 14 for hearings. Senior Advisors on health and safety, headed by Mr. William H. Bricker, president of Diamond Shamrock Corporation, will continue * to guide MCA'activities in this area. TL. F-- Also, an MCA inter-committee task group will prepare a response to the OSHA proposal, coordinated with that of the industry ad hoc group. We will keep you informed of developments. Sincerely. AP0004796I 54148 PROPOSED RULES [4510-26] . which will be introduced into the hearing genic potential to humans, would be, wt record by any party must be filed by no believe, inconsistent with OSHA's statu DEPARTMENT OF LABOR ' ' later than January 9. 1976; an informal tory obligations and unacceptable to all. Occupational Safety and Hearth Si Administration [29 CFR Part 1990] . IDENTIFICATION, CLASSIFICATION^AND hearing Is scheduled to begin March 14, Thus," OSHA proposes an orderly and 1978. - comprehensive set of regulations to FOR FURTHER TACT: INFORMATION CON identify, classify and regulate potential carcinogens in American, workplaces. 'This action Is based upon three basic REGULATION OF TOXIC SUBSTANCES Mr. James Foster. Office of Public Af* propositions, namely: POSING A POTENTIAL OCCUPATIONAL fairs, OSHA. Third Street and Consti 1. That the term `'carcinogen," al CARCINOGENIC RISK tution Avenue NW., Room N3641. though perhaps difficult to define as a AGENCY: The Occupational Safety and ' ^ Health Administration, Department of Washington. DC. 20210 C202-523- matter of science, must be defined for 8151). 'purposes of overall regulatory activity. " . * _ Labor. . . 7. ACTION; Proposed rule and notice of hearing. SUMMARY: The Occupational Safety and Health Administration (OSHAJ proposes a new general regulation con cerning the identification: classification and regulation of toxic substances in American workplaces that may pose a carcinogenic risk to workers.* This pro posal is necessary to allow OSKa to deal in a comprehensive way with the im-. portant problem of worker exposure to man; toxic substances which ms; be potential or confirmed occupational car- cinogens. This broad rulemaking pro- ceeding is intended-to establish: new procedures and a regulatory framework for regulating exposures to potential oc cupational carcinogens;' OSHA's scien tifically based policies concerning the identification and classification of po tential occupational carcinogens;' and three model standards for use in spe cific rulemakings involving such sub-' stances. The three proposed model standards incorporate OSHA's views concerning which protective provisions are generally the most appropriate to protect employees permanently against exposure to categories of toxic sub stances, as defined, and, In the model emergency temporary standard, which protective provisions are necessary to protect 'employees from the danger of cancer and which can be instituted Im mediately. Once promulgated in this rulemaking therefore, these proposed procedures, identification and classifi cation criteria, and, as qualified above, the provisions of the model standards will be consistently applied and, as dis cussed in this proposal, foreclosed from reconsideration in future regulatory ac- tivity pursuant to these proposed regu lations. -* OSHA Invites written comment on these proposed regulations and all of the issues raised or Implicit therein- In that regard, OSHA has scheduled an,Informal public hearing for the receipt of oral testimony as well, as pointed out below. Dates: Written comments concerning the proposed art of regulations and no tices of Intention to appear at the hear ing., must be postmarked on or before December" 8, 1977; all materials and direct written testimony of witnesses Later additional cuPparta to tbls Fart may be added to include other generic ap proaches to ether toxic substances, sucb as, . . SUPPLEMENTARY INFORMATION: Pursuant to sections 6(b),-8(c), and 8 (g) of the Occupational Safety and Health Act of 1970 (the Act) (84 St&t. 1593, 1599, 29U.S.C. 655, 657) ,ttie Secre tory of Labor's Order -76 (41 FR 25059) and Title 29 of the Code of Federal Regu lations (CFR), Part 1911, It is proposed to amend Title 29 of the Cfr by adding at this time a new Part 1990, a subpart A to Part 1990 to deal with the identifica tion, classification and regulation of toxic . substances. In general, and a subpart B to Part 1990 to deal with the Identifica tion, classification and regulation of toxic substances, as defined, for which there is reported to be evidence of car cinogenic potential to humans. These regulations would apply to all employ-' merits in all industries covered by theAct. Including general industry, con struction. maritime and agriculture. OSHA requests the submission of writ ten' comments, data and arguments from interested persons on the variety of scientific, technical and procedural is sues addressed or Implicit In this pro posal. In addition, an informal hearing has been scheduled to provide an oppor tunity for presentation of evidence con cerning the Issues and to facilitate the conduct, of this rulemaking. This proposed set of regulations at tempts to deal with one of the most im portant Issues OSHA faces, namely the exposure of workers to toxic substances which may be potential or confirmed occupational carcinogens. At the outset, OSHA recognizes that some 1,500 to 2.000 agents have been identified by the Na tional Institute for Occupational Safety and Health (NIOSH) as being "suspect carcinogens" (Suspected Carcinogens; HEW Publication No. (NIOSH) 77-149, December, 1976).- By definition, this means that NIOSH has found some' sci entific evidence, of varying degrees of quality and quantity, identifying those substances as having potential carcino genic activity, based on observations In human populations or on results from experimentation with laboratory test animals. Yet. OSHA has completed reg-' ulatory activity for only 17 of those sub stances since its creation oh April 29, 1971. OSHA recognizes that In regulat ing occupational exposure to potential carcinogens, many gaps remain in our knowledge of cancer, its causes, preven tion and cure. However, to wait for years to resolve these issues scientifically with- ' out some consistent and workable system . . 2. That a toxic substance, determined as a carcinogen in a mammalian test animal system, as defined. Is to be treated cs a policy matter as posing a carcinogenic risk to humans. 3. That when OSHA is dealing with a toxic substance, identified as a carcino* *gen, as defined* herein, the permissible exposure limits will be set as low as feasible. In cases where there are suit able substitutes that are found to be less hazardous to the worker, no occupa tional exposure to the toxic substance will be .permitted. In other words, unless there is evidence submitted in this rule making sufficient to convince the Sec retary of Labor that this general policy Is incorrect namely, that there is pres ently no means to determine a safe ex posure level to a carcinogen, the per missible exposure limits will be set as low as feasible or occupational exposure will not be permitted in certain cases, both determinations to be made in the individual rulemakings conducted pur suant to this subpart. In short, utilizing best available and generally accepted scientific knowledge to establish the carcinogenicity of a sub stance. OSHA proposes, in general, to rely on evidence from human epidemio logical studies, adequately designed and conducted animal studies, or both The degree of conclusiveness of such data may permit regulation of the toxic sub stance as a Category I toxic substance or a Category n toxic substance. This set of regulations also provides' for the clas sification of toxic substances for which further development of data may be needed before any regulatory activity as 1 to .carcinogenicity is concerned (Cate- . gory 333 Toxic Substances) or for toxic substances which OSHA believes are not found in American workplaces although the evidence shows that if they were, they would be classified pursuant to this subpart (Category IV Toxic Substances)- The classifications of Category I and I* toxic substances will require OSHA to Initiate appropriate regulatory through the means of one or more of the three model standards, to control pr eliminate exposure to the toxic stance, by way of engineering control* work practices, respirators or housekeeping procedures. The conten and format of these model standards, pointed-out below, are to be followed subsequent rulemakings pursuant this subpart, except where-OSHA de*" mines that unique properties of the t. substante require deviations, 8 for example, those posing a potential oc for the regulation of toxic substances, or' changes from the general cupational teratogenic or muUgeale risk. for which there is evidence of a carcino ments found in the model stacdords- KOEIUL RfCISTU, VOL 42, NO. 192--TUESOA^ OCTOBE8 4, 1977 -fasft Ca.f( W A dk t: 7996 AP00047962 October S, 1977 Page 11 'PESTICIDE & TOXIC CHEMICAL NEWS KEPONE CANCELLATION HEARING ON ACCESSIBLE PRODUCTS TO BE DISMISSED Accepting almost verbatim the arguments by the Environmental Protection Agency counsel that parties filing objections to the cancellation 'of accessible Kepone products have not set forth any factual basis upon which a hearing would be required, presiding Administrative Law Judge Edward B. Finch has granted EPA's motion to dismiss the case and ordered the parties to file their proposed findings, conclusion and order {See Sept. 14, Page 2). In explaining his decision that the Kepone registrants have not met the requirements of the Rules of Practice for filing objections to a proposed cancellation. Finch stated: "EPA's actions in the April 11, 1977, Notice of Intent to Cancel and the July 21 modification were supported by a thorough analysis and weighing of the risks and benefits of the EPA Scientific Advisory Panel, the U.S. Department of Agriculture and the Agency's Pesticide Program Office. Petitioners' responses to these Notices do not challenge the factual basis underlying the Agency's . position-in these notices, nor do they challenge the way the Agency reached its conclusion from the supporting data. "The detailed exposure and risk analysis, the benefit analysis and the Agency's assessment of risks and bene fits go unchallenged by the Petitioners who seek a hear ing before the Agency. The objections made by Petitioners are either vague and without foundation or immaterial." Finch acknowledged that the basic argument made by most of the firms opposing cancellation concerned the Impact that cancellation would have on them as small business and observed that "impact on the manufacturer is not a relevant considera tion." To back up his position, he quoted the Interim Guidelines for Economic Impact Analysis of Proposed Regulatory Actions to Control Carcinogenic Pesticides, which says: "The impacts on pesticides manufacturers are not germane to this type of regulatory decision, in which risk of the use of a pesticide is compared to the benefits of those uses." In denying the parties' request for a hearing. Judge Finch ordered that the parties file their proposed conclusions and order no later than Oct. 14, 1977. OSHA CANCER POLICY TO WEATHER RULEMAKING; BENIGN TUMORS GET LOTS OF WEIGHT A procedure for identifying, classifying and regulating potential carcinogens in U.S. workplaces was scheduled to be published in the Oct. 4 Federal Register by the Occupational Safety and Health Administration (OSHA). AP00047963 Page 12 Octobers, 1977 . PESTICIDE TOXIC CHEMICAL MEWS The procedure, which was vigorously debated at a Washington, D.C., symposium in June (See June 8, Page 12), contains essentially the same features as the draft dis cussed earlier. According to the proposal, OSHA would classify chemicals into one of four categories , Placement of a chemical into Category T would prompt immediate Issuance of an OSHA "emergency temporary" standard forcing reductions in worker exposures, medical surveillance as well as other "model" actions which would be taken' for aLl Category I substances. WithLn 60 days of the classification, OSHA would begin rulemaking in an effort to propose a permanent standard reducing exposure to the "lowest feasible" level, in terms of technology, or prohibiting exposure entLrely if a "suitable" substitute existed. The proposal states that a chemical wouLd be considered a Category I substance if it has been found to cause benign or malignant tumors in "(1) humans, or (2) two mammalian test species, or (3) a single mammalian species, if those results have been replicated in the same species In another experiment, or (4) a single mammalian species If those results are supported by short-term tests." A substance may be classified as Category I also if the OSHA Secretary "finds that any other evidence Is sufficient to convince him that the toxic substance should be classified as Category I." "The agency proposes to place as much weLght on an experiment in which only benign tumors are observed, as upon experiments in which both malignant and benign tumors are Induced," the proposal declares. Proposal Defines "Replication" of a Positive Finding In One Test Species On replication, the proposal states that a positive result -- benign or maligant tumors -- would be considered to have been replicated "if a similar significant increase in tumor Incidence Is induced in the same or different strain of the particular species so long as the experiments were carried out independently (i.e. at the least, with independent sets of control animals)." This means that If OSHA were to rely on bioassay data generated by tests on.only one species or straLn of animal, "replication" would not be accomplished if the finding of "statistically significant" numbers of tumors was based on data from only one set of "historical" control animals (See Aug. 3, Page 34). The other "sufficient" evidence upon whLch the OSHA Secretary may base a Category I classification, the proposal states, could include evidence that a substance "generate5 non-statistlcally significant but extremely rare or unusual tumors, such as brain tumors, that might not otherwise, standing alone, meet the other criteria for Category I classification. This might also include evidence from a single, exceptionally well conducted test on one animal species." Category II classification would mean that a substance has been found to be positive In an "unreplicated experiment in a single mammalian species," or that the OSHA Secretary again has found evidence "sufficient" to justify placement of the substance into Category II. Category II classif[cation would prompt no emergency temporary i AP00047964 OcLober 5, 1977 Page 13 PESTICIDE & TOXIC CHEMICAL NEWS standard, but a permanent standard would have to be proposed no later-than 60 cays after the classification, and the standard would have to reduce exposure to a level "low enough to prevent acute or chronic toxic effects." i It is the intent of the proposal to promulgate a "model'' emergency temporary standard, as well as model standards for Category I and Category II substances, respectively Any substance-specific deviations from the models would have to be justified end explained by OSHA, the proposal states. In rulemaking on permanent standards for Category I and II substances, issues to be left open for discussion would be Limited so that the proceedings will not be bogged down by "traditional" regulatory arguments such as the inapplicability of animal test data to humans, threshold levels, etc. For Now, OSHA Won't Correlate Structures to Find Suspect Carcinogens "At least at this time," the proposal states, "OSHA does not propose to rely upon structural similarities between known carcinogens and other substances" when con sidering regulation of the "other" substances (See Sept. 7; Page 15). However, the proposal notes that this issue may be rendered "moot" by Environmental Protection Agency testing requirements under the Toxic Substances Control Act (TSCA) which may, in fact, be based on "molecular or structural similarities." Category III substances would be those where there is Insufficient data to permit a higher level of classification, and Category IV substances would be those chemicals which could fall into any of the other categories but are not found Ln LJ.S. workplaces. At a press briefing Oct. 3 devoted to the proposal. Labor Secretary Ray Marshall said the "generic" cancer policy would be better than OSHA's past policy of attempt ing to regulate substances one-by-one. "Trying to control carcinogenic substances on a case-by-case basis is like trying to put out a forest fire one tree at a time," Marshall said. Also at the briefing, the Society of the.Plastics Industry (SPI) distributed a statement saying it was in "fundamental disagreement with OSHA's apparent intent to rush to unequivocal enforcement judgments on the basis of limited scientific knowledge of carcinogens." SPI said the proposal "is nothing more than an attempt by a regulatory agency to devise a quick fix method of dealing with the admittedly difficult task of reducing the risks of occupational cancer. No push button formula will provide the right answers," SPI said. Acrylonitrile was mentioned at the briefing as one substance which OSHA would con sider as Category I (See May 25, Page 21). OSHA Secretary Eula Bingham said OSHA would not wait for the proposal to be promulgated Ln final form before proceeding with regulation of substances believed to pose carcinogenic risk. She said she hoped other Federal agencies would consider OSHA's policy in each agency's respective deliberations over suspect carcinogens. AP00047965