Document rB9vrwpZ85Ynwag7Nn8Dqnpmq

THE REFRACTORIES INSTITUTE 1102 OLIVER PLAZ> PITTSBURGH, PA. 1322: July 18, 1978 To: The Official Representative of Each Active and Associate Member Company in the United States: Subject: PRELIMINARY CLASSIFICATION OF SUSPECTED CARCINOGENS The day after the Institute's testimony at the OSHA hearings on suspected carcinogens, OSHA released its long-awaited preliminary classifications. While these lists are only tentative and subject to change as the rulemaking process continues, they do give us the first authoratative indication of how chemical substances in use in the refractories industry may be controlled. I am attaching a list of OSHA's proposed Category I, II and III classifications for chemicals reported by members of the TRI Safety and Health Committee as being in use in the industry. There are 14 substances classified as Category I, five as Category II, 22 as Category III, and one (Silica) classified both as Category II and III--a situation I am trying to clarify. Needless to say, I was disappointed to see so many Category I classifications for our industry. Chromium compounds received more attention than I expected, but coal tar and coal tar pitch compounds received less. Remember^however,..... that these are only tentative classifications. CATEGORY I Exposure to substances classified as Category I is considered to constitute "a grave danger1* and such chemicals are proposed to be regulated most strin gently, first under an emergency standard, then under a permanent standard designed to reduce workers' exposure to the "lowest feasible level" or possibly zero if substitutes are available. Activities required of manufacturers or processors by the proposed permanent standard include (i) exposure monitoring and measurement; (ii) regulated (limited access) areas; (iii) control through engineering and work practices; (iv) respiratory protection; (v) protective clothing and equipment; (vi) housekeeping; (vii) waste disposal; (vlii) hygiene facilities; (ix) medical surveillance; (x) employee training; (xi) precaution ary signs and labels; and (xii) recordkeeping. The extent of these activities would be similar to those discussed at the May meniership meeting in connection with the proposed silica standard, but the cost impact would probablv varv from substance to substance. A 2- - CATEGORY II Category II substances are potential carcinogens for which the evidence is "only suggestive" rather than convincing. They would be regulated less stringently, but the regulation would require most of the activities mentioned above in one form or another. A major difference is that ex posure limits, instead of being at the "lowest feasible level", are to be set at the level of existing OSHA standards (29 CFR 1990.1000), or (where none exists) at "an appropriate level based upon acute or chronic effects of exposure...other than carcinogenicity", or, if the present OSHA standard is inadequate to prevent those effects, it shall be lowered by the Secretary to an "appropriate" level. Also, there is no emergency standard provision for Category II substances, nor a requirement for regulated areas, nor the need for special lunchrooms. The difference in the cost of compliance for a Category I classification compared to Category II for a given substance could vary from trivial to catastrophic, depending upon the difference, if any, between an "appropriate level" to prevent acute or chronic effects from exposure and the "lowest feasible level". CATEGORY III Category III substances require no special new controls but since they are recognized toxic substances there may already be recommended or regulated exposure limits which should still be followed. Category III substarices can of course, be upgraded to II, or II to I, if new test results or other con vincing scientific information is forthcoming. STRATEGY If the OSHA procedure is adopted as proposed and these classifications are upheld, it is obvious that many extremely expensive and far-reaching changes in how the industry does business will be required. This is1 hot the^tlme to -v throw in the towel, however. It is_ the time to get to work on developing a counterstrategy. If you have any data on these Category I or II classifi cations which would indicate they are incorrect (overly stringent), now is the time to get It together. In fact, if you can get such information in ny hands by August 1, I can have it included in the post-hearing record. Of particular interest here is the question of whether Chromium (III) should be controlled to the same degree as Chromium (VI), as well as the question of whether either deserves a Category I classification. Beyond that, it will take further discussions and planning to decide how TRI should respond to these initial classifications. One thing seems clear to me, however, and it is this: we stand a much better chance of softening their impact if we start work immediately instead of waiting for OSHA to publish final classifications. The time for response later when a notice of proposed rulemaking appears in the Federal Register will be far too short to accomplish any thing of significance. 0 -3- I would appreciate hearing from each member who expects to be affected by these classifications as quickly as possible during the post-hearing comment period. OWW/hm cc: Environmental Protection Committee Safety and Health Committee Technical Advisory Committee Toxic Substances Subcommittee H. W. Fulton, Jr. PRELIMINARY CLASSIFICATION OF SUSPECTED CARCINOGENS REPORTED BY SOME REFRACTORIES PRODUCERS CATEGORY I CATEGORY III .etic acid. Lead (2+) salt bestos nzene rbon Tetrachloride romic acid. Chromium (3+) salt (3:2) * romic acid, Dipotassium salt romic acid. Disodium salt romite romi um omium (III) oxide' (2:3) -omium (VI) oxide (1:3) lylenediamine, N,N*-Dimethyl,N` Dinitroso -pen tine snic acid CATEGORY II yl alcohol n (III) oxide roleum -oleum asphalt ianthren.e ica. Crystalline (also Category III) Anthracene Boric acid Brucite Cellulose, Carboxymethyl ethe Sodium salt Cobalt (II) nitrate (1:2) Cobalt (2+) oxide Ethylene oxide Fluorescein, Disodium salt Hexamethyl enetetramine Iron (II) sulfat'e (1:1) Magnetite Mercury 9-0ctadecenoic acid (Z) (Syn: Oleic acid) Olivine Phenol 1 Phenol, Pentachloro(Syn: Dowicide G) Polyethylene Polyethylene glycol (Syn: Carbowax) Polyvinyl alcohol (Syn: PYA) Silica, crystalline (also Category II) Silver Stearic acid. Methyl ester Styere polymer A SpI.Rpt -- 11 administrator has a "heavy burden" to 'captain the basis for his decision to permit the continued use of a chemical known to produce cancer in experimental animals." EDF v. Racketshaut (DOT}. 439 FJd $64. 396 n.l (D.C Cir. 1971): accord. EDFv. ERA (heptachlar and chiordane). 564 fid 998.100$ (D.C. Cir. 1978). cert, denied. 431 U.5. 92$ (1977); EDFv. EPA (aldrin and dtekinn). $10 FJd at 1302: see EDF v. Department of Health. Education and Welfare. 428 FJd at 1000-42. When firm evidence esubliihes that a chemical ia a carcinogen, statutes generally leave an administralorno alternative but to step in to protect the public. "On the ether hand, when the evidence ia leas than firm, but merely suggests that a chemical may be a cardaogea. the same 'heavy burden' may not attend administrative inaction. The decision to act in such a case has been held to fall within the discretion of the Administrator. For example, in Reserve Mining Co. v. EPA. $14 f.2d 492 (8th Cir. 197$) (en banc). EPA sought to abate discharge of mining refuse into Lake Superior 'under an acceptable but unproved medical theory.' that the discharges were carcinogenic 514 FJd at 529. The court concluded that the discharges should be abated, even though there would be a heavy cost, including possible loss of many jobs, to the local economy. Id. et 514-20.535--40. Similarly, in Certified Color Manufacturers Association v. Mathews. 543 FJd 254 (D.C Cir. 1976). the Food and Drug Administration (FDA) terminated its provisional approval of a color additive used to dye food on the besis at a vigorously debsted study of the additive's carcinogenic effects. This court concluded that the FDA actioa should be upheld, based upon FDA's scientific Judgment that the study was not conclusive, but was merely suggestive of carcinogenicity. Id. at 297. "Courts have traditionally recognized a special judicial interest in protecting the public health, particularly where "the matter Involved ia as sensitive and fright-laden as cancer.' Where the harm envisaged ia cancer, courts have recognized the need for action based upon lower stendsrds of proof than otherwise applicable.' Id. at 297-46 (footnotes omitted) quoting EDF v. EPA (DDT). 46$ FJd $28. $36 (D.C. Or. 1972). The courts have frequently upheld regulations based on evidence of caroiaogetuc effects. Sec. e.g- American Iren trSteel Institute v. OSHA. No. 75-2358. slip op. at 31-32 (3d Cir. March 23.1978) (coke oven emissions): Society of the Plastics Industry r. OSHA. $09 FJd at 1311 (vinyl chloride): Synthetic Organic Chemical Manufacturers Association v. Brennan. $03 FJd 113.1159-60 (3d Cir.) (same), cert, denied 420 U.S. 973 (1974). * "The** cesea demonstrate that inevitable tension attending regulation of carcinogens. Frequently, such regulations have severe economic impact. Indeed, sometimes, as alleged by industry petitioners in this case, such regulations may jeopardize plants or whote industries, and the jobs depending on them. In such circumstances, the temptation to demand that the agency furnish conclusive proof of carcinogenicity as support for the regulations is great. However, the decision to delegate authority to an agency to control suspected carcinogens is * legislative judgment that is noi open to question in this court. Congress's direction to CPA to protect against incompletely understood dangers could not be earned out if we were to adopt the proof requirements advocated by industry petitioners.' This proposal marks a departure from OSHA's usual pattern of a substanceby-aubstance approach in setting health standards concerning exposures to potential occupational carcinogens. For the reasons set forth herein. OSHA believes that such an approach ia not only proper and necessary but in fact compelling because of its 'experience gtined under this and other health and safety laws'. (The Act section 6(b](S].} Moreover. OSHA believes that by establishing a rational and predictable policy concerning the regulation of exposures to occupational carcinogens, employers, employees, the general public, the scientific community and public interest groups will not only * benefit from improved employee health, but also experience greater efficiencies in their own activities.* Employees are exposed to many substances on a daily basis. Obviously, most of these substances are not carcinogenic. Yet. some may be. OSHA believes that this general policy and. procedure wiH facilitate the sifting through the evidence concerning substances which may be imputed to be potential carcinogens and the application of uniform, predictable criteria in order to assess whether such substances should indeed be treated as carcinogenic. Without such a system and appropriate criteria. OSHA believes that this task cannot be accomplished in a timely and efficient manner. With an appropriate system and criteria, worker health will be protected efficiently without rediscussing or relitigating, time and time again, the same issues and without unnecessarily draining limited industry, union, public interest scientific and government resources. As a result of this policy, OSHA believes that these limited resources will focus on the most *Whils,OSHA wilt not elaborate span the Ungthy time coronating 'earr-by-ease* ndcaakiage experienced by otiler agendas under ether statute*, to excellent discussion of the nai problem* appears in McCerity. "SobiuntUre end Procedure! Discretion in Adautiimthre Reeolation of Science Policy Qucstioa*: Regulating Cardnogea* ia EPA end OSHA'. 67 Georgetown Lew journal 724 (Ftbruery 1979). Aleo etc Berger end Rlskis. Economic end Technological Feeeibiliiy is Regulating Toxic Subetencce Under the Occupational Solely end Heelth Act 7 Ecology Lew Quantriy 2S$ (1971). The triewific commentelcro have elec recoauneoded e (faerie rather then e cete-by-ceee approach. la regulating caranofcu foe the eeao reatone. See National Academy s( Science*--National Research r--t DcdaionBUkinf for Regulating ft--in the Eavvoamaat 21 (197$). substantial issues in OSHA rulemaking proceedings, thus leading to more compact and useful Records in a shorter period of time. In addition, this policy will result in continuity of approach, even in (he face of changes of policymakers. This new approach is intended to ameliorate certain administrative problems in standard setting. One significant aspect of past rulemakings concerning carcinogens wu the enormous time period between OSHA*t initial Federal Register notices and final judicial actions. For example, in its nine (9) year history. OSHA has concluded only seven (7) rulemaking proceedings in regulating carcinogens. Moreover, it should be noted that the total Ume the official process took from the date of the first official announcement in the Federal Register to completion of the judicial review of the final standard does not necessarily Include the time required to analyze the facts and develop the proposal in the first instance, which itself can be considerable.** Finally, it should be noted that the procedures followed in each of the following cases differed because of an attempt to speed up the process. None of the differing procedures succeeded in achieving that goal. o. Asbestos An emergency temporary standard regulating occupational exposures to asbestos was published on December 7. 1971 (36 FR 23207) and not judicially contested; .permanent standard was proposed on January 12.1972 (37 FR 466) and. after a abort hearing, was published in finaliorm on June 7*. 1372 (37 FR 11318); the permanent standard was contested in industrial Union Department. AFL-QO v. Hodgson on July 27,1972. and affirmed in 499 FJd **OoJy two other health standards have been promulgated daring the history of OSHA namely: standard* regulating occupational axpoaurro to Inoifatticlead and cotton duet In the case of the standard regulating occupational axpoaoro to lead, the proposed final standard was pobilshed on October X 3973 (40 Ffl 4S4ML axtanaivo hearings WS and the final standard published on November 14.1871. a procaaa that look over 38 month*. An appeal Is pandins In the Court of Appeals for the District of Columbia in Lead Industries. Inc. v. OSHA. In tho case of the standard regulating occupational expoturt In cotton duet, an advance entice at proposed rolemeking was publlabad on December 27.1774 (39 FR 44769), a propoeed permanent standard published on December 28. 19TO (41 FR 544M). extensive hearings held In April and May of 1977. and final standards published aa to Cotton Dual and Cotton Dust In Colton Cine or June 23.1971 (43 FR 27330 and 274141. a process that took over 41 months. Appeals were feeautly deeded by the Court ot Appeals (or the District of Columbia ia Aft~aO v. Marshall tad Texas Independent Cinneft Assoc, v. Marshall 467 on April 17.1974. tne entire process consuming about 29 months.* b. Fourteen Carcinogens On July 8.1972. OSHA requested information concerning fifteen substances (37 FR 13245). A package of fourteen (14) emergency temporary standards regulating occupational exposures to a like number of carcinogens was published on May 3. 1973 (38 FR 10929). contested in part in Dry Color Manufacturers'Assn. v. Brennan and vacated on October 4.1973 by the Third Circuit Court of Appeals at 486 F-2d 98: an advisory committee was appointed and began its meetings on June 25. 1973. the proposed permanent standard was published on July 16.1973 (38 FR 18800) and amended on August 18.1973 (38 FR 22141). a hearing was held in September 1973 and the final standard published on January 29.1974 (39 FR 3756). contested In Synthetic Organic Chemical Manufacturers Assn. (.SOCMA) v. Brennan T fEIJ on January 'S. 1974 and SOCMA v. Brennan Q rMOCA) on February 4.1975. In SOCMA . Brennan L the Third Circuit affirmed :n part in 503 F.2d 1155 on August 28. 1974. cert. Ben. on March 17.1975 in 420 J-S- 973. A petition for rehearing was ienied on October 6.1975. In SOCMA v. Irertnan IL the Third Circuit affirmed in C6 F.2d 38S on December 17.1974. A letition for certiorari was filed on darch 20.1975 and denied by the Supreme Court on October 6.1975 sub om. Oil. Chemical and Atomic Vorkers v. Dunlop in 423 U.S. 830. The ntire process consumed about 40 tooths. . Vinyl chloride A fact-finding hearing concerning inyl chloride was announced on muary 30.1974 (39 FR 3874) and held n February 15.1974. An emergency mporary standard regulating tcupational exposure to vinyl chloride as published on April 5.1974 (39 FR 341) and not judicially contested, a oposed permanent standard was tblished on May 10.1974 (39 FR 18898). e permanent stendard published on ctober 4.1974. (39 FR 35892). contested The Society of the Plastics Industry v. SHA on October 1.1974. end affirmed 509 F-2d 1301 on fanuery 21.1975. tl den. sub nom. Firestone Plastics 3. v. US. Department of Labor in 421 5. 992. on May 27.1975. the entire ocess consuming IS months. 'Th* C8ACtf*UIIA| pfQpfRMl lbtIOI **f > gitd at * bain lor thv 1972 OSHA aibeitoi trtdard d. Coke oven emissions An advisory committee concerning occupational exposures to coke oven emissions was appointed on August 12. 1974. and held twenty-eight days of meetings during which testimony was presented by numerous experts and parties snd over 200 exhibits received, the proposed permanent standard was published on July 24.1975 (40 FR 40849). promulgated on October 22.1978 (41 FR 48742). contested in American Iron end Steel Institute v. OSHA on October 23. 1978. end affirmed in 577 fJd 825 on March 28.1978. petition lor certiorari pending in the United Stales Supreme Court the entire process consuming 68 months so far. , e. Arsenic An advance notice of proposed rulemaking concerning occupational exposures to inorganic arsenic waa published on June 11.1974 (39 FR 20494), s fact-finding hearing was announced on Auguat 3a 1974 (39 FR 31844). held on September 2a 1974. s proposed standard waa publiahed on January 21.1975 (40 FR 3392). a final permanent standard published oo May 5.1978 (43 FR 19584). contested in ASARCO v. OSHA on May 5.1978 and ]udidal review is pending in the Ninth Circuit Court of Appeals and decision has been deferred pending the result of the Supreme Court decision in the case of the contested standard regulating occupational exposures to benzene, infra. The entire ongoing process has therefore consumed 67 months. /. Benzene Aa emergency temporary standard regulating occupational exposures to benzene was published on May 3.1977 (42 FR 22518). Hayed in API v. OSHA by the Fifth Circuit Court of Appeals on May 2a 1977. a proposed permanent standard was published on May 27.1977 (42 FR 27482), published in final form on February ia 1978 (43 FR 5918). contested in American Petroleum Institute v. OSHA on February 2.1978, and vacated In 581 F-2d 493 on October 5.1978. certiorari granted in Marshall v. API 440 U.S. 906 on February 21.1979 by the United Slates Supreme Court, the entire process, so far. consuming 31 months. g. Acrylonitrile On June 29.1977 (42 FR 33043). and July 5.1977 (42 FR 34328). OSHA requested public comments concerning occupational exposure to vinyl cyanide or acrylonitrile. An emergency temporary standard regulating occupational exposures was published on lanuiry 17.1978 (43 FR 25861. contested on fanuapr 17.1978. the stay was dented in Vistiron v. OSHA on March 28.1978 in the Sixth Circuit a permanent standard was proposed on January 17.1978. (43 FR 45782). hearings held (a March and April 1978 and the final standard issued on Octobers. 1978 (43 FR 45782). That final standard was not Judicially contested, although the entire process consumed 16 months even Iter the Manufacturing Chemists Assodalion and Dow Chemical Co. on the one hand and E. L du Pont dc Nemours k Co. Inc. on the other hand informed OSHA that such substance was a potential carcinogen based on both animal and human evidence in March and May of 1977 respectively. A. Beryllium In the esse of a standard regulating occupational exposures to beryllium, the proposed standard was published on October 17.1975 (40 FR 4814). Hearings were held during August and September 1977. A final standard la pending with the process to date having consumed at least 51 months. In sum. OSHA believes that the length of lime consumed in official regulatory and (udieixi processes will be shortened after the promulgation of this Part for the following reasons: the periodic announcement of regulatory priorities and advance notice of identification and dasaification criteria will enable all participants in the regulatory process. Including OSHA staiL to act with greater efficiency and certainty in framing the truly critical issues in any rulemaking and locating the requitedtechnical and scientific expertise early in the proceeding. This should shorten sad sharpen the rulemakings. Also the reviewing courts will be presented with rulemaking records of Improved coherence, relevance and reduced size, aiding their deliberations. Other administrative problems faced by OSHA in promulgating regulations in this area on a case-by-case basis are expected to be mitigated by these regulations. OSHA had slated that the present system unreasonably takes the time of scientific experts who were asked to present statements wni-w;{ Identical issues in various proceedings. For example. Or. Rail (Director; NIEHS) testified: "...I think the discussion of the issues can and should continue forever. Mr. Hanson (of Dow Chemical Co.) Which forum, sir? Dr. Rslk In scientific forums. Sometimes the regulatory agency has to My--end I think it is perfectly proper-dial we accept the current state of knowledge end regulate on the basis of it. The point resilv >> thal the