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CHEMICAL REGULATION REPORTER' A weekly review of activity affecting chemical users and manufacturers Volume 3, Number 51 THE BUREAU OP NATIONAL AFFAIRS. INC. March 21,1980 HIGHLIGHTS CONFIDENTIAL DATA will be included in premanufacture notification information the En vironmental Protection Agency intends to submit the comment period on the rule be extended until EPA develops a more complete rulemaking record (p. 1956). to Senator Edmund Muskie (D-Maine), accor ding to an EPA draft reply to Muskie's request for the information. The draft outlines plans to in form Muskie's staff on procedures for protecting the confidential data (p. 1953). DIBROMOCHLOROPROPANE cancellation proceedings will include field hearings in Los Angeles, Phoenix, and Honolulu, an EPA ad ministrative law judge announces (p. 1956). . THE VETERANS ADMINISTRATION has been aware since 1977 of serious health effects caused by veterans' exposure to Agent Orange in Vietnam, two Congressmen charge. Thomas Daschle (D-SD) and David Bonior (D-Mich) release a copy of an unsigned memorandum, on VA stationary, stating that Agent Orange com ponents are mutagenic and teratogenic (p. 1954). PREMANUFACTURE NOTICES will be divid ed by EPA into "fast track" notices, which pre sent little concern and can be quickly reviewed, and "slow track" notices, which require more deliberate study, according to an agency official (p. 1955). VINYL CHLORIDE carcinogenic effects are increased in test animals that consume moderate amounts of alcohol, a researcher tells a Govern ment-sponsored conference on vinyl chloride toxicity. Other researchers report that the sub stance can increase the risk of cancer for off spring of exposed pregnant animals and that the substance can cause cancer at exposure levels as low as 10 parts per million and exposure periods as short as 49 hours (p. 1955). THE EVIDENCE AGAINST 2,4,5-T and silvex is overwhelming, EPA Deputy Assistant Ad ministrator Steven Jellinek says, as the oral phase of cancellation hearings begins. Dow Chemical Company charges that 2,4,5-T is being victimized for political reasons. EPA plans to in troduce testimony from European researchers that the herbicides' dioxin contaminant caused cancer in humans, bringing protests from Dow, which demands to see the underlying data (p. 1957). GENERIC REGULATION of chemical car cinogens may result in overregulation of thousands of relatively safe substances, an American Industrial Health Council represen tative warns (p. 1957). EPA WOULD EXEMPT almost two-thirds of the potentially hazardous wastes produced by in dustry from regulation under proposed hazardous waste rules, a Senate Government Affairs over sight subcommittee report charges. The report recommends that hazardous waste criteri ia inelude radioactivity, genetic activity, bioac cumulation, and the criteria established under the Clean Water Act (p. 1958). EPA SHOULD JUSTIFY individually each of the 2,300 chemicals for which it proposes to issue reporting requirements under Section 8(e) of the Toxic Substances Control Act, the Chemical Manufacturer's Association says in comments on the proposed rule. The association requests that THE REFERENCE FILE SUPPLEMENT with this week's Current Report includes the EPA rules for hazardous waste management un der the Resource Conservation and Recovery Act, a new Reference File index, and final tolerances for four pesticides. Section 1 Cooynght 4 1980 by The Bureau of National Attain. Inc. R&S160114 4* 1952 In this i -* * ' -. * r* , v- .., *: CHEMICAL REGULATION REPORTER ''4 Topical Summary AGENT ORANGE AIMRmPOonLnUdmnmONrefutes VA `nuaittan. i MM Cn^ofn rate may Impane rtakaen rani arms, officials __ '* ------------- ----------- --------------~.............. .... 1M7 ladostrr crttictas EPA notice to regulate Tmiiimdil w 1959 Uisrm" patter usr DtBROMOCHLQROPROPANE CcUtk pracaHnp to incindt-Arts. CaBC. Hawaii ENTORcS&EriT "** ----------------------- :---------- i EPA awards states 6L4 minion to study toxic FULL TEXT 7 UH My* <* EPA regaladonsondar developmtat--------------- IMS "j* M applications tar MTS exemptions__________ __ lMO MTB (nuts ad dwdals of exemption MpUctotaar ...___1973 J22 ,*?<lrotetic testing ofpipelines_____ 1979 MTB proposal to IKUpOWt dOCBBMfltt OB ptpsUat tdBa CEftjERrAaL/"P*O~L-I"C-Y- 1 1,75 lUMiattan I b.y--E--P--A--advtecrs MmSSi hazardous materials CHEMTREC MBiettw _____ I by DOT. HAZARDOUS SUBSTANCES LafaaroOcials aapport MU Impotoag peatottanJcr concealed IMS HAZARDOUS WASTE FPi| f gm on werinr protection___ IMS HEALTH HAZARDS Right to toxics tafanrutfcm major USR says _... IMS INTERNATIONAL POLICY journE***'*" *Urt*dbTEEC -- LABELING OSHA to review regulatory analysis ------- ----. PESTICIDES MSS . Agreement signad by EPA. Lahartodevetoptannarproton-^ _ oonjaujiam...............--........................................ ... 1M1 f~ I rt nil ITft nmt iih illnlimai Iiliiflia In itotliiiiiilm lino EPA pubHahat toterapcea. PIPELINE SAFETY - MTB propoaaf iwhiml lulling ......... PREMANUPACTURE PHjnPTCATION EPA i jtoi New track i to spend review niosh to develop aaaiytkal IMS RjEsPOsRTsINGssssss^j&stwrrr1S*M RESEARCH wrative^. I WASTE . j -. Santos pent! says EPA will w <r- Hally hade weetan-------- State snryy Btoi< BBoftoo ianoH LAW - raayt _ MM VIQNuYoL (SlqR1IDE - inaann(_ WATER POLLUTION This, of Chamtato: Currant Rapoat lades: and Sactloo 3. i ted t Section la, saFIla CHEMICAL REGULATION REPORTER PttMMwd ai Watodegton. O.C. every Friday, except for a yearend ttsup.br The Bureau of National Affairs, Inc:. Washington. D.C 20037. Telephone: (2021 (52-4200. Editor in Chief: Winiam A. Baits Exeaoxot Editor: Stanley E Degler Anociat* Editor: Patriae R. Westleto BOARD OF EDITORS Managing Editor: Mary Worobec Inara Apinis Jane O'Brien Areento Michael H. Blake. Jr. Hay M. Druley lany Faricas TM R. Fraemmiag EUea L Hamilton Terry Hammood Brace Hathaway John C. Liaeto Cheryl Russell Milan Rubda Philip A. Topor Glenn Totten Senior Legal Editor: Stanley J. Gilbert Senior Scientific Editor: Girard L. Ordway wTBpOBBBB nBCtflUl ffllinfill i to titt iRituotBi editor, Sotacripttao rate (payable in advance) 077 per year. Tb code at the tattoo* of wane pans of this report I that copies at the pages tor ase beyond that permitted hy Seettana 107 and lot at the new U-S. Copyright Act may bemadeepaijaymant of a SAceto par page copy fee to the Copyright Oeeranc* Center. lac., P.GBox 765. Schenectady, N.Y. 13301, or directly to The Bunaa at National Aliairs. Inc. Second das Postage paid to Washington. D.C. and at additional fwtHng oiflees. Copyright ' 1960 by The Bureau oi National Allairs. lac. AB rights reserved by the copyright owners. ISSN: 0141-7971 Printed in 1LS*A. 3-21*80 Chemical Regulation R< oue.ren'oomoaso - I* v _i Q3o3 m 1956 CHEMICAL REGULATI N REPORTER The increase was over 30 percent in all according to Maitoni. groups, Short gapoout-- Robert Hebir of the Consumer Product Safety Commis sion reported the results of experiments involving relatively brief exposures to vinyl chloride. He described studies in which test rodents were given between one and 100 one-honr exposures to vinyl chloride vapors. No statistically significant response resulted from single one-boor exposures, even at concentrations as high as 50,000 ppm, Hehirsaid. Hbwever, a significant increase in long tomandid occur in a group of animals given 49 one-boorexposures to 500ppm of vtayf-ridoride over a 10-week period. H told the conference that a comparison of this result with other pohlisbed reports suggests that vinyl-chlnride-indnced cancer incidence is related to the total dosage receiv- Bopoftinq ` MORE DETAILED RULEMAKING RECORDS-. MUST BE KEPT ON EACH CHEMICAL* CMA SAYS . The Chemical Manufacturer's Association is salting' the Environmental Protection Agency to extend the comment period on its recently proposed reporting requirements Car *300 chemicals until the- agency develops individual dossiers for each chemicaL 'The March 17 request; asking for a more- detailed' ndemaking record and a lengthiercomment period on- thenic proposed February 29 under Section Mi) of the Toxic Substances Control Act, la in keeping with the groop's oftrepeated stance grossing; tbe need for rnkmaldngaccoun tability for each and every substance indnded in the rale (Current Report. February 29; p. 1798, 1831). The industry position is diametrically apposed to- the generic approach EPA has been developing: under T5CA. The petition also reinforces CMA's position that EPA must make an "unreasonable risk" finding for each in dividual chemical the agency plans to include in a labeling rule. The petition is CMA's latest effort urging EPA to set up chemical-by-chenncai selection criteria. Using the QUA plan for manufacturer review of agency decisions; however, might cause mamfacturera to spend more time checking agency data than they would spend filling out the relatively short Section 8(a) reporting form, sources said. The petition indicates the industry group is anxious to pre vent future, and perhaps more burdensome, requirements from using one underlying basis for rulemaking for all chemicals involved. This first response to the Section 8(a) rale came asa sur prise to the agency since the proposed rales were not ex pected to be very controversial, an EPA staff member said. The selection or inclusion of certain chemicals, however, and the requirement to submit customer information, always were expected to raise some objections. CMA'a Requests Besides asking far an individual justification for each chemical oo the list, CMA asked the agency to explain the process for reviewing the chemicals. The group also asked EPA for its rationale for requiring the reporting, including a description of the scoring or selection progress. cma also wants the record for each chemical to include any information collected by the Interagency Testing Com mittee or by EPA in subsequent study of the chemicaL EPA said in its proposal that many of the chemicals were selected from ITC scoring lists. The industry group argued that the five general criteria givenby EPA in the proposal do not give sufficientindication of how the chemicals were chosen because the proposal does not sped oat which criteria were applied to which chemicals. Finally, CMA asked EPA to extend the comment period on the proposal until 60 days afterall requested information is compiled and indaded to the public record. ' Although EPA has not replied yet, any decision to compile such a detailed record could delaytheruleindefinitely. CMA vewgniti this fact in tis petition when it pointedout how long it would take a manufacturer to gather such material for even a limited number of the chemicals. .. - Ofbromochloropropaoq CANCELLATION PROCEEDINGS TO INCLUDE HEARINGS IN ARIZONA. CALIFORNIA. HAWAII Portions of Environmental Protection Agency hearings to consider the cancellation of registrations of dUxomocfaloropropane (DBCP) will be conducted in Los Angeles, Phoenix; and Honolulu, EPA Administrative Law JudgeGerakLHaiwood "w*wna<* March IS. Various participants had reqneafod field hearings on the West Coast and elsewhere to accommodate local witnesses iadadlag' migrant winkers; farmers, and agricultural experis (Current Report, March 7, p. 1871). Harwood; who will preside-at the hearings; said he mpy dedde later to hold attritions! field hearings in other reqoestcd locations, such as Georgia, Florida, and Texas; Hsrwood schednled another prebearing conference for April 30 and set April 20 as-thr deadline far ptrtidpanisIn-exchange witness fists and exhibits. 2.43-T CASS AGAINST HERBICIDES OVERWHELMING. JELL1NEK SAYS AS HEARINGS GET UNDER'WAT The evidence that the phenaxy herbicides 2,4,5-T and SUvex pose a hazard to health is "overwhelming.'' according to Environmental Protection Agency Deputy Administrator for Pestirides. and Toxic Substances Steven D. JeUhtek. Jelllnek released a public statement March 14 to mark the beginning of the oral phase of the hearings on EPA's propos ed cancellation of registrations of the herbicides. The hearings, in Washington. D.G, are expected to-con tinue for four days each-week-foe one to. two years. In the first days of the formal proceedings, which began March 14, herbicide supporters cross-examined EPA witnesses on the health risks of continued use of the herbicides. In his statement, Jellinek summarized theagency position in saying, "What makes the 2,4,5-T evidence overwhelming is its volume. What makes it unprecedented is its quality." own -2.43-Tl*- Seine VhMmtfd' Etcyi Blair. Dow Chemical Company vice president and director of health and environmental sciences, related his firm's disagreement with EPA. lira March 14 public statement. Blair said EPA is seeking to ban 2,4.5-T oat of "politically expedient" motives, even though the agency's scientific data have- been discredited. 3-21-80 Chemical Regulation Reporter CURRENT REPORT 1955 The planned system would be more efficient, the official explained, and would allow better use of agency personnel by allowing them to set aside quickly those notices which pre sent little concern. At one time, EPA treated all notices the same throughout the review period. The agency, however, quickly learned that such an approach would not work once the volume of notices being submitted increased. It then established the 40-day preliminary screening and discovered that one of every six or seven notices needs a mare detailed review, the EPA official told Chemical Regulation Reporter March 17. While the new review system would establish a "slow track" and a "fast track" for different new chemicals, the EPA official stressed that the agency still wUl review every new chemical. , A new ch+<ei cannot be dismissed on the basis of its chemical structure alone, he said. Even though its structure may be similar to an existing chemical or the substance may be part of a group of chemicals considered to be innocuons, the agency cannot dismiss the chemical without considering its application and exposure, he noted. - Even structurally related chemicals map vary hr fat solubility, in ability to be broken down by light, or in other characteristics which alter their potential for creating hazards, he said. ... Continuing Leek of Oeta The agency is trying to find more ways to get data on in dividual notices. The EPA official noted that afta many months of receiving notices, the amount and quality of data received on new chemicals has improved veejr little ... There are two troubling trends, be sakLThe first, one which the agency has complained about on numerous oc casions, is the lack of test data on new substances. Many of the notices contain no test data and-almost, none have presented any subchronic or chronic studies, he noted. Industry is not keeping promises it made to submit infor mation on new chemicals, he said. Same of the suhmiters, many of them large firms with long-term experience in the chemical industry, have refused to provide use information, he said. He complained that some of the firms which promised a cooperative effort in submitting PMN information now are refusing to supply basic information. Industry is shirking responsibility for testing new chemicals, he said, adding that he sees no evidence of a trend indicating industry intends to assume such a respon sibility. Exemption Requests The second problem facing the agency in the review of the notices is an industry trend to submit a test marketing ex emption (TME) request with the premanufacture notice. - Since the TME must be approved or disapproved within 45 days, the agency is forced to perform the review mare quick ly, he explained. The trend could lead to instances where the agency lacks evidence at 45 day? to disapprove the TME but decides later in the PMN review period to take some regulatory action on the new substance, he noted. If the trend continues, the agen cy will have to uncouple the two reviews, he said. In recent weeks EPA has taken several actions to rein force its position that PMNs and TMEs should include adequate information and test data. Such efforts include the rejection of some submissions as inadequate. Another is increasing interest in using sig nificant new use rules to require future reporting for sub stances which complete review without any regulatory ac tion being taken. Vinyl Chloride ALCOHOL INCREASES CANCER EFFECTS, UNIVERSITY RESEARCHER TELLS CONFERENCE Alcohol drinkers mar have increased susceptibility to the carcinogeniceffeets of vinyl chloride vapors, a Government- sponsored conference was told March 20. ^ Martha Radike, of the University of Cincinnati, reported the results of a study in which laboratory rats were given , water containing 5 percent ethanol and were exposed to vinyl "chloride. The animals that received alcohol had a much higher in- ddence of vinyl-chloride-induced malignant tumors than the .'rats exposed to vinyl chloride alone, she said. The test animals were exposed to a concentration of 600 part per million vinyl chloride vapor, four boors each day, five days a week for one year. Control groups exposed to vinyl chloride alone and to alcohol alone had elevated tumor rates in comparison with ,, control group not exposed to either substance, Radike reported. The tumors in the alcohol-only group tended to be benign, rather than malignant, she said. Radike compared the level of alcohol given to the test animals to a moderate drinking level, similarto a six-pack of beer or a few glasses of wine. She said the experiment was suggested by the fact that ethanol and-vinyi.cbloride are known, to share a.step in the .metabolic pathway. Radike suggested that epidemiological studies, should be carried out on human papulations exposed to vinyl chlorid to determine whether, chronic alcohol use is related to . cancer incidence. , ..... ... .. .. . .,,..i The two-day conference on.vinyl chloride, toxicity was sponsored by the National Institute of Environmental Health and Safety, the National Institute for Occupational Safety and Health, and the Occupational Safety and Health Ad ministration. ,,: .,... The conferees heard reports from 37 researchers, in cluding Caesar Maiton! of the Institute of Oncology and Tumor Center in Bologna, Italy. Inhalation Studies Maltoni reported the results of extensive inhalation studies in rodents at various dose levels ranging from one to 30,000 ppm. In' long-term studies, test rats developed increased in cidences of cancer at levels as low as 10 ppm, Maltoni said. The OSHA standard for worker exposure to vinyl chloride sets a maximum limit of one ppm, averaged over an eight-hour period. Maltoni's experiments involved exposure of test animals for four hoars a day, five days a week, for varying periods. He reported that the test animals exposed to vinyl chloride suffered a variety of tumors, including cancer of the liver, lung, kidney, stomach, skin, brain, mammaries, and Zymbal's gland. May Affect Fatua Maltoni also reported a study suggesting that exposure of a pregnant animal to vinyl chloride can increase the in cidence of cancer in her offspring. He described experiments in which female rats were ex posed during pregnancy to vinyl chloride vapors at concen trations of 6,000 and 10,000 ppm. The offspring of the exposed rats later developed a.higher incidence of liver cancer than the offspring of unexposed control rats, Maltoni said. -i rf ^1