Document r62KpgXoL0KRo5ej7jeqp6m4V

4 THE REFRACTORIES INSTITUTE 1102 OLIVER PLAZJ 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, ^emember^however,. that these are only tentative classifications. CATEGORY I Exposure to substances classified as Category I is considered to constitute **a grave danger" and such chemicals are proposed to be regulated most strin gently, first under an emergency standard, then under a permanent standard designed to reduce workers1 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 (1) 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; (vili) 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 membership meeting in connection with-the proposed silica standard, but the cost impact would prob3bl^j^SE^TM substance to substance. -- |r. ~~ ------- 1 I 13 PLAINTIFF'S \i.JP*9n ? s 2- CATEGORY II Category II substances are potential carcinogens for which the evidence is "only suggestive1* rather than convincing. They would be regulated lessstringently, 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 substances 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 is'hot the'-tlme to- v throw in the towel, however. It js, 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. I would appreciate hearing from each neuter who expects to be affected by these classifications as quickly as possible during the post-hearing cotrcnent period. JWW/hm cc: Environmental Protection Committee Safety and Health Corrmittee Technical Advisory Committee Toxic Substances Subcomnittee H. W. Fulton, Or. i PRELIMINARY CLASSIFICATION OF SUSPECTED' CARCINOGENS REPORTED BY SOME REFRACTORIES PRODUCERS . CATEGORY I CATEGORY III ^cetic acid. Lead (2+) salt Ashestos lenzene Carbon Tetrachloride Chromic acid. Chromium (3+) salt (3:2) Chromic acid. Dipotassium salt Chromic acid. Disodium salt Chromi te hromium -omium (III) oxide* (2:3) Cnromium (VI) oxide (1:3) Ethylenediamine, N,N*-Dimethyl- N,N' Dinitroso Serpentine Tannic acid CATEGORY II Ethyl alcohol Iron (III) oxide Petroleum Petroleum asphalt Phenanthrene Silica, Crystalline (also Category III) {% Anthracene Boric acid Brucite Cellulose, Carboxymethyl ether, Sodium salt Cobalt (II) nitrate (1:2) Cobalt (2+) oxide Ethylene oxide Fluorescein, Disodium salt Hexamethylenetetramine Iron (II) sulfate (1:1) Magnetite Mercury 9-0ctadecenoic acid (Z) (Syn: Oleic acid) Olivine Phenol Phenol, Pentachloro- (Syn: Dowicide G) Polyethylene Polyethylene glycol (Syn: Carbowax) Polyvinyl alcohol (Syn: PVA) Silica, crystalline (also Category II) Silver Stearic acid. Methyl ester Styere polymer 0 SpJ.Rpt - 1 1 administrator hat a "heavy burden" to ~xpUm the basis for bis decision to permit the continued uac of chemical known to produce cancer in experimental ammala." EDF v. Ruekeishous JDOTJ. 439 F'Od U4.996 n.41 (O.C. dr. 3971): octant EDF v. ERA (hcpuchlor and chlordane). SM Fid 99*. 1009 (C.C Cir. 1976). cere denied. 431 U.S. 929 (1977): EDFv. CPA (aldna and dteidnn). 910 F2i at 1302: tee EDF v. Department of Health, Education end Welfare. 428 Fad at 1000-92. When Cm evidence establishes that a chemical la a eamnofeo. statutes gcaeraiJy leave an administrator no alternative but to tep in to protect the public. "On the ether hand, when the evidence la leea than firm, but merely lUQtitt that a chemical may be a cardao|eau the aaote "heavy burden" may not attend admuiiatrauv* inaction. The derision to am la tueh a case haa been held to (all within the discretion of the Administrator. For example. Is Reserve Mining Co. v. EM. 914 FOd 492 (6th Cir. 1979} (cn banc). CPA aoujht to abate discharge of mining refuse into Lake Superior "under an acceptable but unproved medical theory." that the diaehargea were carcinogenic. 914 Fad at 929. The court concluded that the discharges should be abated, even though there would be a heavy coat Including possible loss of many jobs, to the local economy. Id. at 514-20. 539-40. Similarly, in Certified ColorManufacturers Association v. Mathews. S43 Fdd 284 (D.C Cir. 1976). the Food and Drug Administration (FDA) terminated its provisional approval of a color additive used to dye food on the basis of* vigorously debated study of the additive's carcinogenic effect*. This court concluded that the FDA action ebould be upheld, based upon FDA's scientific Judgment that the study was not conclusive, but wes merely suggestive of carcinogenicity. Id. at 297. "Courts have traditionally recognized a special Judicial Interest (n protecting the public health, particularly where "the matter Involved is aa sensitive and fright-laden as cancer." Where the harm envisaged la cancer, courts have recognized the need for action based upon lower standards of proof than otherwise applicable." Id. at 297^8 (footnotes omitted) quoting EDFv. ERA (DOT). 465 FOd 528. sag (D.C. Or. 1972).The courts have frequently upheld regulation* baaed on evidence of cardaofenie effect*. See. e.g, American Iron pSteel Institute v. OSHA. No. 76-2398. slip op. at 31-32 (3d Or. Match 26.1978) (coke oven emissions): Society ofthe Flatties Industry v. OSHA. 569 FOd at Uli (vinyl chloride);Synthetic Organic Chemical Manufacturers Association v. Brennan. 903 Fid 115.1199-80 (3d Or.) (same), cert denied. 420 US. 973 (2974). "These cates demonstrate that inevitable tension attending regulation of earcinogena. Frequently, such regulations have severe economic impact. Indeed, sometimes, as alleged by industry petitioners in this case, such regulations may Jeopardize plants or whole Industries, end the Jobs depending on them. In such circumstances, the temptation to demend that the agency furnish conclusive proof of carcinogenicity ts support for the regulations Is great. However, the decision to delegate authority to an ageney to control suspected carcinogens is.s legislative judgment that is not open to question in this court Congress's direction to EPA to protect agiiflil incompletely understood dangers could not be earned out if we were to adopt the proof requirements idvoeattd by industry petitioners." This proposal marks a departure from OSHA's usual pattern of a substance* by-substance approach In setting health standards concerning exposures to potential occupational carcinogen*. For the reasons set forth herein. OSHA believes that lueh an approach la not only proper and necessary but in fact compelling because of Its "experience gained under this and other health and safety laws'*. (The Act. section 6(b)(5).) 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 txperienee greater efficiencies In their own activities.* Employees ere 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. proeadura wiH facilitate the sifting through the evidence concerning substances which mty 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 sueh 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 effidently without rediscutsing or wlitigating, 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 tVUi OSHA wttl Mt <Ubettt poa the kagtby tla* eeiuu0iia| aeiie*by<*ie* rJeouiiftft experienced by ether i|udu coder etber subnet. a exexileat discussion at tbs mm problem appears In McCerity. "Substantive end Proctdure! Ditavdoa la Administrative Brsolutiao of Science Policy Qutstieea: ftpsUttai CudM|t* La CPA tad OSHA". 17 Cearietowu Law Journal 724 (Ftbruery 1979). Alaa m Barter sod Wsiia. foonomk and Technological feieibOiry i* BefuUtint Toxic Subeunccs Under the Occupation*! Safety and Health Act 7 Ecnlo|y Law Quarterly 289 (1071). The adeaufk commentator* have tia recoastadad a |wn(. isihet iha a eiu4fciii approach, to fefoUiiA| carsoofeiu far (he tame reason*. See Netsoul Acadeasy of Science*' Nation*) Xtttareh CounoL Oediionmeiifl| far Sctulaiins ChaaicaU in the Environment S3 (1S73). substsntiei 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 the face of changes of policymaker*. This new approach is intended to ameliorate certain administrative problems in standard setting. One significant aspect of past rulemakings concerning carcinogens was the enormous time period between OSHA's inititl Federal Register notices and final judicial actions. For example, is its nine (9) year history. OSHA has concluded only seven 17) rulemaking proceedings in regulating carcinogens. Moreover, it should be noted that the total time 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. Hone of the differing procedures succeeded in achieving that goal. a. Asbestos Aa emergency temporary standard regulating occupational exposures to asbestos was published on December 7. 2971 (36 FR 23207} and not judicially contested: a permanent standard was proposed on January 12.2972 (37 FR 466} ani after a short hearing, was published in finaUorm onJune?. -T972 (37 FR 22316): the permanent standard was contested in industrial Union Department. AFL-CtO v. Hodgson on July 27,1972. and affirmed in 499 F-2d Oniy two oiher health standards b*v* been proanl|sud dunes the history of OSHA namely: staadaRk rtteUtint occupational axpeeura la ieofguielcad tad tattoo dust. to the cut af the SUndafd tvyttUUAs oeespedwul exposure to feed, the peupaoed final tuadxrd was published an OctoberX1973 (40 FX 459ML extensive ktarint* mud the standard published aa November 14.ten. a )IWU Out tack ate* 36 month*. An appeal Is (Madias in tb* Court of Appeal* for the DUtttct ofColumbia in LeadIndustrie*. Inc v. OSHA.In the c*m of 6m standard refukUnf acespatfoeef txpaeure to esttoa dual aa tdvenec node* af proposed ruleaukir { wee published an December 27.1974 (39 FS 447S9). proposed permanent standard published a December 28. 1971 (41 Fit 94494). extensive beenne* held (n Apnl tad May af 1977. *ad fiat! sisadsid* published *s to Cano* Duet end Genoa Dust to Cattea Cm or. joa* S3.3971 (43 FX27330 4ad 1741*1. proetta that took ever 42 month*. Appeete were recently decided by (be Court af AppeaU for (be Diatnct of Columbia inAFt^CtQn.Menhell t&d Teio* Independent Cinnert Aseoa v u~~k-n Sctf.Rpt. - 12 447 on April 17.1974. tne entire process d. Coke oven emissions contested on January 17.1971 the Key consuming about 29 months.* An advisory committee casesRung wet denied in Vistiron v. OSHA on March 211971 in the Sixth Circuit a b. fourteen Carcinogens occupational exposures to coke oven permanent standard waa proposed on On July 6.1972. OSKA requested information concerning fifteen substances (27 FR13225). A package of fourteen (14) emergency temporary standards regulating occupational exposures to a tike number of carcinogens was published on May 3. 1973 (32 FR10929). contested In part in Dry Color Menufocturers'Assn. v. emissions was appointed on August 11 1974. and held twenty-eight days of meetings during which tcstiaoay was. presented by numerous experts and parties and over 200 exhibits received, the proposed permanent standard was published on July 24.1S7S (40 FR 40649k promulgated on October 2L1976 (41 FR 46742). contested In American Iron end SteelInstitute v. OSHA on October 23. January 17.1971 (43 FR 45782). bearings held la March and April 1972 end the final standard issued on October 3.1978 (43 FR 45722). That final standard waa not Judicially contested, although the entire process coasuaed 16 months even after the Manufacturing Chemists Association and Dow Chemical Co. on the one hand and E. L da Font do Nemours 2 Co. !n& on the other hand Brennan and vacated on October 4.1973 1976. and affirmed in 577 F-2d 225 on informed OSKA that such .substance by the Third Circuit Court of Appeals at March 22.1972. petition for certiorari was a potential carcinogen based on 486 Fid 92; an advisory committee was pending in the United States Supreme both animal and human evidence in appointed and began its meetings on Court the entire process consuming 66 March and May of 1977 respectively. June 25.1973. the proposed permanent months so far. standard was published on )uly 16.1973 (32 FR12600) and amended on August e. Arsenic h. Beryllium la the case of a standard regulating 16.1973 (38 FR 22141). a hearing was An advance notice ofproposed occupational expoaures to beryllium, the held in September 1973 and the final rulemaking concerning occupational proposed standard was published on standard published on January 29.1974 exposures to Inorganic arsenic was October 17.197$ (40 FR 4214). Hearings (39 FR 3756). contested in Synthetic published on June 11.1974 (39 FR 20494). were held during August and September Organic Chemical Manufacturers Asia a fact-finding hearing was announced on 1977. A final standard It pending with (SOCMA/ v. Brennan I (El) on January August 3a 1974 (39FR 21644). held on the process to date having consumed at '3.1974 and SOCMA v. Brennan 0 September 2a 1974. a proposed standard least 21 months. (MOCA) on February 4.1975. In SOCMA waa published on January 21.1975 (40 In sum. OSHA believes that the length v. Brennan L the Third Circuit affirmed FR 3392). a final permanent standard of time consumed in official regulatory in part in S03 F-2d liSS on August 26. 1974. cert. den. on March 17.1975 in 420 published on May 5.1978 (43 FR 19564). and Judicial processes will be shortened coBtesitd.inASARCO v. OSHA on May slier the promuJgetion of this Fart for U.S. 973. A petition for rehearing was denied on October 6.1975. in SOCMA v. Brennan U. the Third Circuit affirmed in 506 F-2d 365 on December 17.1974. A 5.1972 and Judicial review is pending in the Ninth Circuit Court of Appeals and dediloo has been deferred pending the result of the Supreme Court dedsion in the following reasons: the periodic' announcement of regulatory priorities and advene* notice of Identification end classification criteria will enable all . petition for eertiorari was filed on March 20.1975 and denied by the Supreme Court on October 6.1975 sub nam. Oil. Chemical andAtomic Workers v. Dunlop in 423 U.S. 230. The the ease of the contested standard regulating occupational exposures to benzene, in/re. The entire ongoing process has therefore consumed 67 months. participants in the regulatory process, including OSKA Steffi to act with greater efficiency and certainty in framing the truly critical issues in any rulemaking and locating therequiad. . entire process consumed about 40 /. Benzene technical and scientific expertise early months. An emergency temporary standard in the proceeding. This should shorten and sharpen the rulemakings. Also the c. Vinyl chloride regulating occupational exposures to reviewing courts will be presented with A fact-finding hearing concerning vinyl chloride was announced en January 30.1974 (39 FR 3274) tad held on February 15.1974. An emergency temporary standard regulating occupational exposure to vinyl chloride was published on April 5.1974 (39 FR 12341] and hot Judicially contested, a proposed permanent standard was benzene was published on May 3.1977 (42 FR 22512). stayed InAPIv. OSHA by the fifth Circuit Court ofAppeals on May 2a 3977. a proposed permanent standard waa published on May 27.1977 (42 FR 27462). pubUahed in final form on Febatery 10.2978 {49 FR 5925/. contested inAmerican Petroleum Institute v. OSHA on February 2.1972. and vacated in 561 F.2d 493 on October 5.1971 rulemaking records of improved coherence, relevance and reduced size, aiding their deliberations. Other administrative problem* faced by OSHA in promulgating regulations in this area on a ctse-oy-case basis art expected to be mitigated by these regulations. OSHA bad stated that the present system unreasonably takes the time of scientific experts who were published on May 10.1974 (39 FR 16896). certiorarigranted in Marshall v. API 440 asked to present statements concerning the permanent standard published on U.S.90S on February 2L1979 by the identical issues in various proceedings. October 4.1974. (39 FR 35692). contested United States Supreme Court the entire For example. Dr. Rail (Director.N1EHS) . in The Society of the Plastics Industry v. process, so far. consuming 31 months. testified: OSHA on October 1.1974. and affirmed In 509 F-2d 1301 on January 21.1975. cert den. sub nom. Firestone Plastics Co. v. US. Deportment ofLabor in 421 g. Acrylonitrile On June 29.1977(42 FR 33043). and July 5.1977 (42 FR 34326). OSHA *. ..I think the discussion of the lasses can and should continue forever. Mr. Kaaiea (of Dow Chemical Co.] Which forum. U.S. 992. on May 27.1975. the entire requested public comments concerning process consuming IS months. occupational exposure to vinyl cyanide Dr. Rath In sdentifie forum*. Sometimes or acrylonitrile. An emergency the regulatory ajency has to aay--and t think The c*ricif-cavift praptrtiei *f wr* temporary standard reguiating - '----- It is perfectly proper--ahat we accept the eurrn >i.t. at vkawiedte and mutate on