Document RJY0X9zDNZDV4XJbL6B7gYEQa

,s. -V. 1267 Current Report URL 05124 Tmating NTP DRAFT FISCAL 1982 ANNUAL PLAN LISTS CHEMICALS SLATED FOR GENETIC, CANCER TESTS A total of 19 two-year carcinogenesis bioassays will be started and another 27 completed under the National Toxi cology Program in fiscal 1982, according to a draft of the program's annual plan. In addition, 300 substances will be tested in Salmonella for mutagenic activity, 72 will be tested for heritable genet ic effects in Drosophila, and 7$ will be tested for cytogenet ic effects in Chinese hamster every cells, the draft plan noted. Lists of the chemicals to be tested during fiscs! 1982 are published in the Full Text section of this issue. The draft plan, a copy of which was obtained by BNA, outlines NTP plans for the fiscal year beginning in October 1981. Funding levels outlined in the plan are contingent on final approval without change of President Reagan's fiscal 1982 budget request According to the draft, the fiscal 1982 funding level of 874.8 million, up from 868.4 million in fiscal 1961, will allow the program to stabilize the number of chemicals placed on test especially long-term bioassay. It also will allow the program to devote a greater proportion of resources and attention to test methods development and research, accord ing to the draft Carcinogenicity Testing Program In the carcinogenesis testing program, the draft said all 19 chemicals beginning bioamays in fiscal 1982 will be tested using broadened protocols with various special stud ies integrated into the experimental design. The program also will begin three long-term studies not formally a part of the bioasaay program. These studies will examine the cause of Increased risk of buccal and pharyn geal cancer experienced by newsprint pressroom workers, the effects of fiuoride on the fibrogenidty and carcinogen icity of chrysotile asbestos, and the effect of aging In susceptibility to known carcinogens. The program also will complete evaluation of test data received on the mouse lung adenoma test to help determine the feasibility of using this short-term bioassey in carcino genicity testing of chemicals, the draft said. Program Poets Listed Although fiscal 1982 is the program's fourth year. It will be its first year In permanent status. During fiscal 1981, the program took over responsibility for the National Can cer Institute's carcinogenesis Moaasay program. Under the broad objective of providing the necessary scientific information for prevention of human disease relat ed to chemical exposure, the program has four principal goals: * To broaden the toxicological characterization of chemi cals that are tested; To increase the rate of chemical testing as funding permits; To develop protocols appropriate for regulatory needs; and To communicate program plans and results to govern- meat agencies, the medical and scientific community, and the public. Carcinogens SECOND ANNUAL MAGUIRE REPORT TO LIST 8 SUBSTANCES, UP PROM 29 IN FIRST REPORT A total of 88 chemical substances or processes are to be listed in the Second Annual Report on Carcinogens, sched uled for release by the Department of Health and Human Services in about two months. The report, originally slated for release in December 1981, is prepared by the National Toxicology Program. Known as the "Maguire Amendment Report," the annual document was mandated by a 1978 amendment to the Public Health Service Act That amendment requires the depart ment to publish annually a report listing all substances known or reasonably anticipated to cause cancer and to which a significant number of persons in the United States are exposed (Current Report, Feb. 15,1980, p. 1717). The first annual report, released Aug. 8, 1980, listed 25 chemicals and processes (Aug. 8,1980, p. 559). According to an HHS spokesperson, the second annual report is undergoing review and should be ready for release in about two months. A synopsis of the report, however, was included in the NTP annual plan for fiscal 1982, obtained in draft form by BNA (See related article on this page). Substances are entered on the report because the Interna tional Agency for Research on Cancer has determined that there is "sufficient evidence of carcinogenicity in experi mental animals" to classify them as animal carcinogens, because they are regulated by the United States government as carcinogens, because they have been found to cause <-aww in bioassays conducted by the National Cancer Insti tute or NTP, or because they were suggested for inclusion by the UB. agencies that cooperated in preparing the report according to the NTP draft annual plan. Among the 88 substances or processes in the report are naturally occurring substances, additives to foods or cos metics, pesticides, pharmaceuticals, and a large number of substances that are associated with industrial production or are byproducts of manufacture, NTP said. Substances Listed Among the substances listed in the second annual report, but not listed in the first report, are acrylonitrile, carbon tetrachloride, chloroform, a number of dibenzopyrenes, for maldehyde, iindan* mir*T, a number of nitrosamines, poly chlorinated biphenyls, saccharin, TCDD, and toxaphene. The 88 substances oo the list are: 2-Acetylambkofluorene Acrylonitrile Aliatoxins 4-Aminobipheoyl Amitrole Aramite Arsenic and compounds Asbestos Auramine, manufacture of Benz(a)anthraceoe S-12-S2 Canted Reputeson nuorw O14S-7m/2/*MJ0 1268 CHEMICAL REGULATION REPORTER Bagaac Benzidine Denxo(b)fluorantheoc and benzo(j)ftiioranthene Benzo<a)pyrene Beryllium and compounds N,N-Bia(2-chloroethyl}-l-naphthylamine Bia(chloromethyl) ether end chlorocnethyl methyl ether Cadmium and certain compounds Carbon tetrachloride Chlorambucil Chloroform Chromium and compounds Coke oven emissions p-Cresidine Cjcasin Cyclophosphamide 2.4- Diamiootoluene Dibenz(aji)acridine Dlbenz(aJ)acrldine IMtwu(aJi)anthracene 7B-Dibenxo(c,g)carbaiolc Dibenio(aJi)pyrene Dibenao(a4)pyrene lJ-Dibromo-3-chloropropaDe 1,2-Dibromoethane Dlchlorobefaxldine lJ-Dtchkroethane Diethylstilbestrot Dimethyl carbamoyl chloride Dimethyl sulfate 1.4- Dtoxane Pormaldefayde underground mining Hydraaoberaene Indeno(lJ,a-cd)pyrene Iron dextrin Isopropyl alcohol manufacture using strong add procees Kepone Lead acetate and lead phosphate IJurian* mnA nthmr KrrlilfrftPypM>wn lMf MIpAalnii Mirex Mustard gas 2-NaphthyUmine Nickel r^nlng and certain compounds N-Nftroeodi-N-butyiamine N-NitroeodiethanoUmine N'Nltroaodiethylamine N-NitroeodimethyUinine N-Nltroeodi-N-propylamiiie N-Nltroso-N-etbyiorea N-Nltroso-N-methylorea N*Nltroaomethyi vinylamlne N-Nitroaomorpholine N-NitzoeoQaniicotine N-Nitrosopiperidine N-Nitrosopyrrolidine N-Nitrooosarcoeine Oxymethahme Pbenacetin Phenasopyridine hydrochloride Phanytoin Polychlorinated biphenyls ProcarbasiDe and procarbazine hydrochloride 0-PropioUctooe Reeerpine Saccharin Sefrole Soots, tars, and oils Streptozotocin 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCCD) Tlkorium dioxide o-Toluidine hydrochloride Toxaphene Tris(axiridinyl)-phosphine sulfide Tris(2,3-dibromopropyl)phospbate Vinyl chloride * TmmOng PHINYLKNEDfAMINE COMMENT PCIttOO BXTVNOCD; SPECIAL INDUSTRY PANEL FORMED Industry groups seeking extra time to comment on an Environmental Protection Agency advance notice of pro posed rulemaking on phenylenediatnine testing were grant ed partial relief as the agency extended the timetable an additional 30 days to April 8 <47 FH 10597). In written comments on the advance notice, the Chemical Manufacturers Association and the Cosmetic, Toiletry, and Fragrance Association asked that EPA extend the comment period 00 days beyond the original March 9 deadline. CMA said the additional time was needed for a newly formed pbenyleoediamine special program panel to conduct a survey of chemical uses, manufacturers' production vol ume, and human and environmental exposures to the rlwwnfail Hie special panel, which is under the auspices of CMA, wee formed after the agency in January issued the advance notice indicating it may require testing on 13 phenylenediamines end monitoring of 34 other members of that chemical category (Current Report, Jan. 15, p. 1084). EPA is consider ing action on the chemicals under the Toxic Substances Control Act on recommendation of the Interagency Testing Committee. Chemical Menuleoturers Association Tike pbeoylenediamine manufacturers panel "plans to discuss its propoeed survey form with EPA staff before it is e-n--h and to consult with the staff aa the survey proceeds," according to CMA's comments. The panel also will form a toxicology task group to analyse the toxicological issues raised by the agency's ad vance notice, the industry group said. The group will review til available scientific literature on the chemicals and evaluate the agency's suggested testing. The phenylenediamine panel is one of a number of chemi cal manufacturer's groups which have organised the makers of one chemical or chemical category, often under the umbrella of a wider-ranging industry association such as CMA. In a few cases, the groups have offered to conduct voluntary testing in lieu of the agency Issuing a formal test rule under Section 4 of TSCA. Other Comments Tike International Isocyanate Institute Inc. and Eastman Kodak Co. commented on individual members of the phenylenediamines category under consideration for either testing or monitoring by the agency. The institute called on the agency not to regulate 1,3diamine-4-metbylbenzene, 2,$-diamine-4-raetbylbenzene, and diamiDetoloene, claiming that exposure to the chemi cals is low. a-ia-ae Copyrl0* isaa by The hmu ct Nattonw Affair*, Inc. e>4a-7*Ts/*t/aoa*o