TSCA Chemicals-in-Progress Bulletin Office of Pesticides & Toxic Substances (OPTS) Vol. 4, No. 1 January 1983 This news bulletin is intended to inform all persons concerned with the Toxic Substances Control Act (TSCA) about recent developments and near-term plans. For further information or to request copies of documents mentioned, write the Industry Assistance Office (IAO), (TS-799) EPA, Washington, D C. 20460, or call toll-free 800-424-9065 or, in Washington, D.C., or from outside the continental USA, (202) 554-1404. REGULATORY & REQUIRED ACTIONS TESTING OF CHEMICAL SUBSTANCES AND MIXTURES...SECTION 4 Section 4 of TSCA gives EPA authority to require manu- facturers or processors of existing chemicals—those already in commerce and subject to TSCA—to test the toxic effects of a designated substance. To require test- ing EPA must find that the chemical may present an unreasonable risk; that there are insufficient data avail- able with which to perform a reasoned risk assessment; and that testing is necessary to generate such data. A test rule may also be based on an EPA finding of sub- stantial production and exposure to humans or the environment, in addition to findings of insufficient data and need for testing. Under section 4(e) an Interagency Testing Committee (ITC) was established to recommend chemicals to EPA for priority consideration. The ITC cannot recommend more than 50 chemicals or categories of chemicals for testing and EPA must respond within one year to each recommendation by starting rulemaking under section 4 or giving reasons for not doing so. CA Environmental Effects Testing Not Needed Section 4 testing of chlorendic acid (CA) is not war- ranted at this time because environmental release of the substance and its manufacturing precursor, chlorendic anhydride (CAN), is extremely limited, according to recent Federal Register notice. The EPA notice also said available data indicate that such releases are unlikely to present an unreasonable risk. In the October 1 2, 1982 notice (47 FR 44878) EPA was responding to an ITC recommendation included in its October 30, 1981, ninth report to the Agency. In that report the ITC recommended to EPA that CA be consid- ered for environmental effects testing, including chemi- cal fate, acute and chronic toxicity to fish and aquatic invertebrates, and toxicity to aquatic microphytes and algae. The notice said there are only two manufacturers of CA/CAN in the United States. CA is also imported by one of the two manufacturers and releases of CA/CAN by these two firms are low, localized and within applica- ble permit limits, according to the notice. Based on information available to EPA, including confidential business information from the two firms, the notice said that EPA has no basis for finding CA/CAN might present an unreasonable risk to the environment at this time. Limited TCEP Exposure, No Rulemaking Available data on tris(2-chloroethyl)phosphite (TCEP) indicate that production and use of the chemical results in limited exposure risk, according to a recent Federal Register notice. Because of the finding, EPA is not initiat- ing rulemaking to require testing of TCEP, the notice said. The data show that production and use produce only slight occupational exposure and no consumer exposure and there is no known release to the environment, a November 1, 1 982 (47 FR 49466) notice said. The ITC had designated health and environmental effects testing of TCEP in its ninth report to the Agency. It asked that TCEP be tested for the following health and environmental effects: pharmacokinetics and metabo- lism, subchronic and reproductive effects, chemical fate, and acute toxicity to fish, aquatic invertebrates and algae. The Federal Register notice said that TCEP is manufac- turered by three companies in the United States and no one has imported it since at least 1977. The decision not to test in part was based on confidential business infor- mation. The notice also said TCEP production is a closed 1 ------- system and site limited. The compound is made in batches and the production complies with OSHA regula- tions controlling workplace releases of ethylene oxide and other organics used in the production of TCEP. En- gineering controls being used by the three manufactur- ers are designed to help eliminate the release of volatile chemicals exhibiting significant toxicity, such as ethyl- ene oxide, according to the notice. EPA Negotiates Testing for 4-CBTF EPA will not initiate rulemaking to require testing for 4-chlorobenzotrifluoride (4-CBTF) at this time because the sole domestic manufacturer of the substance pre- sented a testing plan that was tentatively acceptable to the Agency. The substance had been placed on the ITC priority testing list on October 30, 1981 (47 FR 5456). The ITC designated 4-CBTF for testing for chronic effects, chemical fate and bioconcentration. A November 8,1982 notice (47 FR 50555) said Occiden- tal Chemical Corp., the sole U.S. producer of the chemi- cal, presented acceptable health and environmental effects testing plans for 4-CBTF after the ITC designa- tion. The Occidental proposal consists of tiered systems for testing both health and environmental effects, with lower tier tests acting as triggers to additional testing if needed, or as stop points following review by EPA. The Occidental plan divides health effects testing into acute toxicity screening (which already has been completed), base set of tests, conditional tests and additional mam- malian testing. The environmental effects testing will be divided into screening, base set of tests and conditional tests. ITC Adds Chemicals to List In its eleventh report (November 3, 1982) the ITC added 11 chemicals to its list for priority consideration and response by EPA wit hin 12 months. The ITC also recom- mended one group of chemicals, carbofuran interme- diates, for priority consideration, but did not specify that EPA had to respond about the group within 12 months. The designated chemicals in the eleventh report are: bis(2-ethylhexyl) terephthalate, dibutyltin bis(isooctyl maleate), dibutyltin bis(isooctyl mercaptoacetate), dibu- tyltin bisflauryl mercaptide), dibutyltin dilaurate, di- methyltin bisfisooctyl mercaptoacetate), monobutyltin tris(isooctyl mercaptoacetate), monomethyltin tris(iso- octyl mercaptoacetate), 1,3 dioxolane, 4-( 1,1,3,3-tetra- methylbutyl) phenol, tris(2-ethylhexyl) trimellitate. Elsewhere in this issue of the Bulletin are reports of EPA actions on chlorendic acid, tris(2-chloroethyl) phosphite and 4-chlorobenzotrifluoride. In its November 3, 1982 letter to the EPA Administrator the ITC issued a revised designation concerning alkyltin compounds, a category included in the ITC seventh report for priority considera- tion. The ITC said it reexamined the 33 alkyltin com- pounds identified in the seventh report plus additional alkyltins in commerce that were later identified by EPA and industry. Based on a review of available information it now has on alkyltins compounds, particularly the level of production and type of use, the ITC has decided to designate seven alkyltin compounds for priority consid- eration and defer the remainder. These seven are included in the 11 designated chemicals mentioned above. Eleventh ITC Report Chemical/Group Recommended Studies Designated for response within 12 months Monomethyltin tris(iso- octyl mercaptoacetate) Dimethyltin bis(isooctyl mercaptoacetate) Monobutyltin tris(iso- octyl mercaptoacetate) Dibutyltin bisfisooctyl mercaptoacetate) Dibutyltin bis(lauryl mercaptide) Dibutyltin dilaurate Dibutyltin bis(isooctyl maleate) Bis(2-ethylhexyl terephthalate 1,3-Dioxolane 4-1,1,3,3-Tetramethyl- butyl phenol Chemical Fate: Mobility of the com- pounds from manufacturing and disposal sites; hydrolysis and bio- degradation; identification of persistent degradation products. Environmental Effects: Acute and chronic toxicity to fish and aquatic invertebrates; toxicity to aquatic plants; bioconcentration. Health Effects: Mutagenicity; chemical disposition and metabo- lism; subchronic effects. Environmental Effects and Chemi- cal Fate; Acute and chronic toxicity to fish and aquatic invertebrates; toxicity to plants; bioconcentration; chemical fate. Health Effects: Mutagenicity; chem- ical disposition and metabolism; 90-day inhalation toxicity. Health Effects: Short-term tests including mutagenicity. Environmental Effects and Chemi- cal Fate: Acute and chronic toxicity; to fish and aquatic invertebrates; toxicity to plants; bioconcentration; chemical fate. Health Effects: Chemical disposi- tion and metabolism. Environmental Effects and Chemi- cal Fate: Acute and chronic toxicity to fish and aquatic invertebrates; toxicity to plants; bioconcentration; chemical fate. Recommended, but not designated for response within 12 months Carbofuran Environmental Effects and Chemi- intermediates cal Fate: Acute toxicity to fish and aquatic invertebrates; chemical fate with particular emphasis on moni- toring studies. The TSCA Section 4(e) Priority List October 1982 Chemicals and Groups Designated for Response Within 12 Months Entry Date of Designation Acetonitrile** April 1979 Acrylamide (environmental effects)** April 1978 Alkyl epoxides October 1979 Aniline and bromo-, chloro-, and/or nitroanilines April 1978 Antimony (metal)** April 1979 Antimony (sulfide)** April 1979 Antimony trioxide** April 1979 Tris(2-ethylhexyl) trimellitate 1. 2. 3. 4. 5. 6. 7. 2 ------- Entry Date of Designation 8. Aryl phosphates April 1978 9. Biphenyl April 1982 10. Bis(2-ethylhexyl) terephthalate October 1982 11. Chlorinated benzenes, mono- and, di- (environmental effects) October 1977 12. Chlorinated benzenes, tri-, tetra-, and penta-(environmental effects) October 1978 13. Cresols October 1977 14. Cyclohexanone April 1979 15. Dibutyltin bis(isooctyl maleate) October 1982 16. Dibutyltin bis(isooctyl mercaptoacetate) October 1982 17. Dibutyltin bis(lauryl mercaptide) October 1982 18. Dibutyltin dilaurate October 1979 19. 1,2-Dichloropropane October 1978 20. Dimethyltin bis(isooctyl mercaptoacetate) October 1982 21. 1,3-Dioxolane October 1982 22. Ethyltoluene April 1982 23. Formamide April 1982 24. Glycidol and its derivatives October 1978 25. Halogenated alkyl epoxides April 1978 26. Hexachloro-1,3-butadiene** October 1977 27. Hexachlorocyclopentadiene** April 1979 28. Hydroquinone November 1979 29. Isophorone** April 1979 30. Mesityl oxide April 1979 31. 4,4'-Methylenedianiline April 1979 32. Methyl ethyl ketone** April 1979 33. Methyl isobutyl ketone** April 1979 34. Monobutyltin tris(isooctyl mercaptoacetate) October 1982 35. Monomethyltin tris(isooctyl mercaptoacetate) October 1982 36. Pyridine** April 1978 37. Quinone November 1979 38. 4-(1,1,3,3,-Tetramethylbutyl)phenol ... October 1982 39. Toluene** October 1977 40. 1,2,4-Trimethylbenzene April 1982 41. Tris(2-ethylhexyl) trimellitate October 1982 42. Xylenes** October 1977 Other Recommended Chemicals and Groups Entry Date of Recommendation 1. Carbofuran intermediates October 1982 2. Trimethylbenzenes* (except 1,2,4-Trimethyl- benzene; see 40 in list above) April 1982 • see May 25, 1 982 (47 FR 22594(G)) *• In compliance with the EPA affidavit to a Federal Court, a Federal Register disposition notice is expected to be signed by the EPA Administrator on or before December 31, 1982. EPA Disposition of ITC Recommendations (Cumulative Removals from the TSCA Section 4(e) Priority List) December 1982 Chemical/Category Federal Register Notice 1. Acrylamide (health effects) 45 FR 48510 7/18/80 2. Alkyl phthalates 47 FR 335 1/5/82 3. Alkyltin compounds (withdrawn) 47 FR 5456 2/5/82 4. Benzidine-based dyes 46 FR 55005 11/5/81 5. Benzyl butyl phthalate 47 FR 335 1/5/82 6. Butyl glycolyl butyl phthalate 46 FR 54487 11/2/81 7. Chlorendic acid 47 FR 44878 10/12/82 8. Chlorinated benzenes (health effects) 45 FR 48524 7/18/80 9. Chlorinated naphthalenes 46 FR 54491 11/2/81 10. Chlorinated paraffins 47 FR 1017 1/8/82 11. 4-Chlorobenzotrifluoride 47 FR 50555 11/8/82 12. Chloromethane 45 FR 48524 7/18/80 13. 2-Chlorotoluene 47 FR 18172 4/28/82 14. o-Dianisidine-based dyes 46 FR 55005 11/5/81 15. Dichloromethane 46 FR 30300 6/5/81 16. Diethylenetriamine 47 FR 18386 4/29/82 17. Fluoroalkenes 46 FR 53704 10/30/81 18. Hexachloroethane 47 FR 18175 4/28/82 19. Nitrobenzene 46 FR 30300 6/5/81 20. Phenylenediamines 47 FR 973 1/8/82 21. Polychlorinated terphenyls 46 FR 54482 11/2/81 22. o-Tolidine-based dyes 46 FR 55005 11/5/81 23. 1,1,1 -Trichloroetha ne 46 FR 30300 6/5/81 24. Tris(2-chloroethyl) phosphite 47 FR 49466 11/1/82 COMMENCEMENT OF MANUFACTURE NOTICES: SECTION 5 Under section 5(a){1) a person who intends to introduce into commerce a chemical substance not on the TSCA Inventory must notify EPA at least 90 days before begin- ning manufacture or import. On May 15, 1979 (44 FR 28564) EPA published a statement of interim policy concerning section 5, premanufacturing notification (PMN). In the statement EPA said any person who sub- mits a PMN under the interim policy and who (after the 90-day period) begins to manufacture or import the new substance for commercial purposes must inform EPA on or about the date when manufacture or import com- mences, so that the Agency can add the substance to the TSCA Inventory. This reporting requirement is imposed under section 8(b). Listed below and on the next few pages are the latest commencement of manufacture notices EPA has received. NEW CHEMICAL SUBSTANCES FOR WHICH EPA HAS RECEIVED COMMENCEMENT OF MANUFACTURE NOTICES (since publication of the October 1982 Chemicals-in*Progrest Bulletin) PMN No. 80-110 80-111 Submitter CBI=Confidential Business Information Chemical Identification G=Generic Name CBI Do FR Citation Do-Ditto G 2-((2-Methylsubstituted)ethyloxycarbonyl)substituted) 45 FR 42018 phenyl, disulfo, diheteropolycyclic heteropolycycle 6/23/80 G Do Do 3 ------- 80-112 Do G 2-((2-Methylsubstituted)ethyloxycarbonyl)substituted) Do phenyl, disheteropolycyclic heteropolycycle 80-113 Do G 2-((2-Methylsubstituted)phenyl), diheteropolycyclic Do heteropolycycle 80-114 Do G Dioxoheteropolycyclic), diheteropolycyclic heteropoly- Do cycle 80-115 Do G (Dioxo, methylheteropolycyclic), diheteropolycyclic Do heteropolycycle 80-116 Do G (2-Substitutedphenyl), diheteropolycycle hetero- Do polycycle 80-295 Do G Disubstituted nitrobenzene 45 FR 78791 11/26/80 80-296 Do G Ethyl, substituted, ((sulfopropyl) heteropolycyclic) Do methyljalkenyl heteropolycycle 80-297 Do G Ethyl, substituted, methylheteropolycycle tosylate Do 80-298 Do G Substituted, methyl-heteropolycycle Do 80-299 Do G Disubstituted benzene Do 80-300 Do G Bisfnitro, substituted phenyl) substituent Do 81-71 Ethyl Corp. G Alkenylpyrolidinedione 46 FR 19075 3/27/81 81-218 CBI Adipic acid-dipropylene glycol-linseed oil fatty acid- 46 FR 29524 trimellitic anhydride-trimethylol propane polymer 6/2/81 81-295 Do G Acrylonitrile polymer with alkenoic acid alkyl esters, 2- 46 FR 36241 propenoic acid and 2-propenoic acid, 2-methyl 7/14/81 81-298 Do G Copolymer of styrene alkyl acrylate, alkyl methacrylate 46 FR 36243 acid with substituted acrylamide 7/14/81 81-315 Olin Corp. Propoxylated hydrazines 46 FR 44047 9/2/81 81-337 Shell Oil Co. G Epoxy resin modified with substituted organic acid 46 FR 39889 8/5/81 81-342 CBI G Benzenedicarboxylic acid, trisubstituted Do 81-343 Do G Benzenedicarboxylic acid, disubstituted Do 81-383 Do Sodium salt of the sulfonated reaction products of 1 - 46 FR 42330 amino-4-(phenylamino)-9,10-dihydro-9,10-dioxo-2- 8/20/81 ((3'propanesulfonic acid)oxo)anthracene 81-384 Do 1-amino-4-phenylamino)9,10-dihydro-9,10-dioxo-2- Do (propanesulfonic acid)oxo)anthracene, sodium salt 81-414 Do G Polyalkanediol polyurethane 46 FR 45996 9/6/81 81-418 Do G Nitropolyhaloalkylbenzenepolyamine Do 81-437 Do G Polynitro polyhalo alkyl aniline 46 FR 47003 9/23/81 81-441 Do G Mixed mono and dialkyl-dithio-thiadiazoles Do 81-485 Do G Polymer of a substituted alkanediol, a carbomonocyclic 46 FR 48979 anhydride and a substituted alkanoic ester 10/5/81 81-496 Do 3-Hydroxy-1-propanesulfonic acid 46 FR 49946 10/8/81 81-543 Do 3-Hydroxy-1 -propanesulfonic acid, monosodium salt 46 FR 54972 11/4/81 81-574 Do G Polyurethane thermoplastics resin 46 FR 56651 11/18/81 81-630 Do G Poly(ester)-co-poly-(ether) 46 FR 62312 12/23/81 81-634 Do G Protein associated biopolymer 46 FR 62313 12/23/81 81-662 Do G Substituted propionamide 47 FR 1020 1/8/82 82-1 3M Co. G Halogenated derivative of polyethylene glycol 47 FR 1409 1/13/82 82-26 American G Substituted amine 47 fr 3592 CyanamidCo. 1/26/82 82-30 CBI G Polysubstituted alkyl polyamine 47 fr 3591 1/26/82 82-39 Do G Polymer of a diisocyanate, polyglycol and polysubsti- 47 FR 4144 tuted alkyl amine 1 /28/82 82-62 Olin Corp. G Hybrid urethane 47 fr 5933 2/9/82 82-68 Mobay Chemical Co. G Polymer of diphenylmethane diisocyanate and hydroxy 47 FR 6365 alkyl ethers 2/11/82 82-71 CBI G Alkyl aryl amino polyol 47 FR 7310 2/18/82 82-136 Do G Disubstituted heteromonocycle 47 FR 8840 3/2/82 82-138 Do G Trisubstituted phenol Do 82-145 Do G Modified polyester polyurethane from substituted 47 FR 10073 alkanediols, alkanedioic acid and a diisocyanate 3/9/82 82-149 Do G Trisubstituted phenol Do 4 ------- 82-167 Do 82-178 Do 82-179 Do 82-180 Do 82-209 Do 82-210 Do 82-211 Do 82-212 Do 82-213 Do 82-214 Do 82-221 Do 82-222 Do 82-223 Do 82-234 Do 82-245 Do 82-246 Do 82-249 Do 82-252 Uniroyal Chemical Co. 82-254 CBI 82-256 Do 82-257 Monsanto Co. 82-260 CBI 82-271 Do 82-273 Monsanto Co. 82-284 FMC Corp. 82-285 Do 82-286 CBI 82-287 Do 82-288 Do 82-290 Do 82-291 Do 82-292 Do 82-296 Do 82-301 Do 82-304 Do 82-306 Do 82-308 Do 82-309 Celanese Plastics and Specialties Co. 82-310 Do 82-311 CBI 82-312 Do 82-313 PPG Industries Inc. 82-320 CBI 82-321 E.I. duPontde Nemours & Co., Inc. S.C. Johnson & Son 82-329 CBI f? ??? Reliance Univeral Inc. o^-J34 ^n, 82-335 82-336 £ 82-337 Do 82-348 Spencer Kellogg Division of Textron Inc. 82-349 CB, 82-356 Do G Disubstituted benzene G Disubstituted butanamide G Substituted thioic acid ester salt G Disubstituted benzene G Polymer from disubstituted monocycle and disubsti- tuted alkanes G Disubstituted benzene G Disubstituted butanamide salt G Disubstituted benzene G Do G Benzoxazole carbocyanine G Do G Do G Polyester-urethane G Modified aromatic diisocyanate with aliphatic triol G Modified polyurethane G Barium sulfonated red G Modified hydroxy functional acrylic copolymer G Isocyanate terminated polyester polyurethane pre- polymer G Modified polymer of styrene, alkenoic acid, alkenoic esters and substituted alkenoic esters G Poly[(aminoalkylamino)alkylene oxide], aqueous solu- tion m-chlorophenylphenylether G Disubstituted benzene G Acid blocked amine m-chlorophenylphenylsulfide Methylated triphenyl phosphate residue Isopropylated triphenyl phosphate residue G Substituted aryl alkyl siloxane G Disubstituted benzene G Polymer of disubstituted acrylic acid, disubstituted ben- zene and substituted acrylic acid G Disubstituted benzene G Sulfonated copper phthalocyanine dye G Substituted trialkyl silane G 9,10-Anthracenedione sulfonic acid, sodium salt G Neutralized polymer of styrene, alkyl acrylates and sub- stituted alkyl methylacrylates G Quarternary amine functional polyether urethane modified polyglycidyl ether of bisphenol A G Disubstituted benzenamine G Substituted benzotriazole G Cationic substituted acid amide G Do G Unsaturated alkyl amino alkyl dioxolane G Dihaloethylacetate Acetamide-2,2-dichloro-N-(1,3-dioxlan-2-ylmethyl)- N-2-propenyl Phenol, 4-nitroso-, magnesium salt, hexahydrate G Polyester random copolymer G Styrene acrylate copolymer G Poly[(aminoalkylamino)alkylene oxide] G Polyacrylate G 5-Chloro-4-nitro-2-substituted aryloxydimethylaniline G 5-Chloro-2-substituted aryloxyaniline G 2-Chloro-4(N,N-dimethylamino)-5-substituted aryloxy- diazonium tetrafluoroborate G 5-Chloro-2-substituted aryloxydimethylaniline G Urea/carbamate elastomer G Polycyclic sulfonic acid salt G Polymer of 1,4-benzenedicarboxylic acid dimethyl ester; dihydroxyalkane; 1,6-hexanediol; alpha hydro- omega hydroxy poly (oxy-1,4-butanediyl) 4 7 FR 10900 3/12/82 47 FR 11957 3/19/82 Do Do 47 FR 13037 3/26/82 Do Do Do Do Do 47 FR 14220 4/2/82 Do Do 47 FR 15406 4/9/82 47 FR 16403 4/16/82 Do Do Do Do Do Do Do Do Do 47 FR 17666 4/23/82 Do Do 47 FR 18652 4/30/82 Do Do Do Do Do Do Do 47 FR 19781 5/7/82 Do Do Do Do Do Do Do Do 47 FR 20852 5/14/82 Do Do Do Do Do Do 47 FR 22214 5/21/82 Do Do 5 ------- 82 369 Goodyear Tire & G Benzenedicarboxylic acid saturated mixed glycols co- 47 FR 23552 Rubber Co. polyester 5/28/82 82-370 Do G Do Do 82-373 Do G Poly(ester-urethane) Do 82-375 Quaker Oats Co. Formaldehyde polymer with 2-furanmethanol and Do methyloxirane capped 82-377 01 in Corp. G Hybrid urethane Do 82-382 CBI G Polymer of alkenoic acid alkyl esters, 2-propenoic acid, 47 FR 25400 and 2-propenoic acid, 2-methyl 6/11/82 82 383 Do G Brominated xylenol Do 82-384 Do G Bis[bromoxylenol]sulfide Do 82-385 Do G Bis[zylenol]sulfrde 82-392 Do G Hydroxy ethyl ester substituted polybis imide of Do pyromellitic dianhydride 82-396 Do G Substituted oxirane reacted with polyalkylene glycol Do 82-400 Jordan Chemical Co. Potassium N, N-bis(hydroxyethyl) cocoamine oxide Do phosphate 82-408 Hach Co. G Tetra tosylate porphine 47 FR 25401 6/11/82 82-409 Jordan Chemical Co. Postassium N.N-bis(hydroxyethyl) tallow amine oxide Do phosphate 82-412 CBI Anthral[2,1,9-def:6,5,10-d'e'f]diisoquinoline-1,2,8, Do 10(2H, 9H)-tetrone, 2,9 bis(4-aminophenyl) 82-429 Do G Ethoxylated molybdenum amine 47 FR 26234 6/17/82 82-435 Do G Poly[oxy(methyl-1,2-ethandiyl)] aliphatic ether amide 47 FR 27610 of dialkenoic acid 6/25/82 82-438 Do G Aromatic amine ester Do 82-439 Hach Co. G Sulphonated phenyl arsine dibromide Do 82-452 CBI G Benzoxazole oxazolidinone 47 FR 28994 7/2/82 82-453 Do G Benzoxazolium salt Do 82-464 Do G 2-Hydroxyl-3-naphthoic acid N-aryl amide 47 FR 30103 7/12/82 82-480 Do G Polyol polyacrylate Do 82-481 Do G Blocked urethane polymer 47 FR 31063 7/16/82 82-486 Do G Alkyl phosphate ester Do 82-489 The Southland Co. G Sulfurized di-cacboxylic polyglycol ester 47 FR 31956 7/23/82 82-502 CBI G Substituted diazo compound 47 FR 33234 7/30/82 82-503 Do G Water base vinyl acrylic copolymer Do 82-527 E.I. duPont de G Titanium (4+) mixed alcohol complex 47 FR 34187 Nemours & Co. 8/6/82 82-535 Coastal States G Modified phenol formaldehyde substituted alkylamine Do Chemical Co. REGULATION OF HAZARDOUS SUBSTANCES . . . SECTION 6 Under section 6, EPA is authorized to control a chemical as a hazardous substance if the Agency finds that the chemical will present an unreasonable risk of injury to PCB Background Under section 6(e), EPA is required to control the manu- facturing, processing, distribution in commerce and use of polychlorinated biphenyls (PCBs). On May 31, 1979 EPA promulgated a PCB rule. However, on October 30, 1980, the United States Court of Appealsforthe District of Columbia Circuit, responding to a petition filed by the Environmental Defense Fund, set aside that portion of the PCB rule that characterized intact nonleaking PCB- containing transformers, capacitors and electromagnets as totally enclosed. The court also struck down the pro- vision limiting application of the rule to PCBs in concen- trations of 50 ppm or greater for manufacturing, pro- cessing, distribution in commerce and use. The court remanded both parts of the May 31,1979 rule to EPA for further action. EPA Amends PCB Rule EPA has published a final rule excluding the production human health or the environment. Under 6(aj, EPA is requiredto apply one or several requirements of the law to the extent necessary to protect against the risk. of PCBs in closed and controlled waste manufacturing processing from section 6(e) of TSCA. This rule replaces portions of the May 31,1979 rule, which generally pro- hibits the manufacture, processing, distribution in commerce and use of PCBs. The October 21,1982 rule (47 FR 46980) excludes those manufacturing processes from the section 6(e) ban that produce PCBs as a byproduct and impurities, as long as the PCBs released into the air, water or contained in products or wastes do not exceed limits stated in the rule. These limits represent the lowest concentrations of PCBs that can be practically quantified. Although PCBs are no longer being manufactured as a product, many fundamental chemical processes gener- ate PCBs in low concentrations as impurities or bypro- ducts. PCBs can be produced in chemical reactions involving chlorine, hydrocarbons and heat, 6 ------- The final rule modifies and clarifies some of the pro- posed requirements set forth on June 8, 1982 (47 24976). The changes were made because of informa- tion obtained during the comment period and at t e public hearing on the proposed rule. In the proposed rule EPA defined the absence of 'n releases from closed and controlled waste manufactur- ing processes by referencing an analytical technique, in the final rule EPA set numerical cutoffs for purposes o defining the absence of PCBs in such releases. In the proposed rule EPA defined conlroHed waste as wastes disposed of in facilities approved by EP" or disposal of PCB wastes under 40 CFR 761.60, (par o the May 31, 1979 rule on PCBs). In the final rule trA added additional mechanisms, including some Resour e Conservation and Recovery Act (RCRA) approved in i erators, for the disposal of controlled wastes containi g PCBs in concentrations between the limit quantita 10 and 50ppm. In the final rule EPA said it was institutingia new reporting requirement in addition to the recor keeping requirements set forth in the proposed ru e. In addition, the rule requires that manufacturers dispos ing of controlled wastes in RCRA-approved incinera o certify that the incinerator is capable of <^ H readily burned compounds than the PCBs to stroyed, and that the incinerator when burning will be operated under conditions shown to resu i destruction of less readily burned compounds. EPA Denies GE Petition EPA has denied a citizen's petition from the G®"®1"®' Electric Co. (GE) to amend the PCB rule to monochloro biphenyls (MCBs) and dichloro biphieny (DCBs). EPA said the GE arguments about relativeirisks of the two substances may have some techmca > but the Agency said that it would be addressing arguments in the rulemaking that will cover un trolled manufacture of PCBs. If GE felt it was still neces- sary, GE could resubmit the petition "after this major rulemaking is completed," EPA said. On July 14,1982 GE said in its petition MCBs and DCBs are not persistent in the environment and do not 103 cumulate because they are rapidly metabolize ® eliminated from the body. GE also said the health e,tecI °f chlorobiphenyls, especially the lesser chlorina e MCBs and DCBs, are minimal and their exclusion from the PCB rule would be consistent with Congressional intent. GE also said the exclusion would be consistent with the PCB definition used by Canada and the Euro- pean Economic Community. Finally GE said would have a significant economic impact on GE. I denial of the GE petition was issued on October 20, 1982 (47 FR 46723). REPORTING RULES SUBSTANTIAL RISK SECTION 8(e) Under section 8(e) persons who obtain information which reasonably supports the conclusion that a sub- stance presents substantial risk of injury to fiuman health or the environment-must notify EPA within i days. These notices are then reviewed by OTS and an initial evaluation is prepared containing, if appropriate, follow up questions to the submitter, referrals to other agencies, and recommended OTS/EPA followup ac- tions. The 8(e) notices represent a company's first revie wofa situation and a judgment in compliance with the statute to submit a notice within 15 days of obtaining the information. EPA published its evaluations of these notices to make this section 8(e) information widely available and understandable to a broad public. The submissions and the initial evaluations are located in the OPTS Public Reading Room, first floor. East Tower, Waterside Mall, 401 M Street, SW, Washington, D.C. Persons wishing to obtain a copy of section 8(e) notices may write: Ms. Jerri Green, EPA (A-101), Washington, D.C. 20460. There is no charge for duplicating the first 49 pages, but at page 50 of a request for duplication there is a $10.00 fee and a 200 charge for each addi- tional page (e.g., 51 pages cost $10.20). Recent Section 8(e) Notices of Substantial Risk Log No. 8EHQ [CAS NO} 0882-0452 4-Chloro-3-nitroaniline 635-22-3 Summary results from a short term feeding study 0882-0453 Ethylene oxide 75-21-8 Preliminary summary results of a chronic inhalation study 0882-0454 Pentaerythritol triacrylate 3S24-68-3 Pentaerythritol diacrylate 53417-29-1 Pentaerythritol tetraacrylate 4986-89-4 Final results from a chronic skin-painting study 0982-0455 Oil yellow E 190 2481 -94-9 Solvent Red 19 6368-72-5 Final results from an in vitro battery of genetic screening tests 0982-0456 S Gulf TS-905-HWCF Concentrate Preliminary results from (an) acute eye irritation test 0982-0457 Miscellaneous organic chemicals Preliminary analytical results from a study of groundwater contamination 0982-0458 Bis (2,3-dibromopropyl ether) of 21850-44-2 tetrabromobisphenol A Final results from several mutagenicity tests 1082-0459 Oipropyleneglycol diacrylate Summary results from acute eye/skin irritation studies 1082-0460 Pentaerythritol monooleate triacrylate Summary results from a battery of short term in vitro tests 1082-0461 Chlorinated toluenediamine Report of a chronic feeding study. S at the end of Log Number means a sanitized version is available. N.B.: All toxicity, oncogenicity, teratogenicity and mutagenicity studies involve animals unless otherwise stated. Additional tests (e.g., bacterial cell) ere noted or are included in the term "battery." SUPPORT ACTIVITY GPO Reprints Cumulative Supplement II The Government Printing Office (GPO) has reprinted the TSCA Cumulative Supplement II (CSII). GPO sold out the first printing of 2,518 copies, which went on sale in late 7 ------- June. The more than 900-page book is being sold by GPO for $17 a copy. For shipment outside the United States the charge is $21.25. CSII, when combined with the TSCA Initial Inventory of Chemical Substances, published in May 1979, consti- tutes the TSCA Revised Inventory of Chemical Substan- ces. CSII supersedes both Supplement I and Cumulative Supplement I, published by EPA in 1979 and 1980 respectively. There are now over 58,000 chemical sub- stances on the TSCA Revised Inventory. To order CSII from GPO checks should be sent to: Super- intendent of Documents, GPO, Washington, D.C. 20402. The GPO document number for CSII is No. 055-000- 00218-5. GPO will accept Master Charge or Visa credit card telephone orders. The GPO order desk number is (202) 738-3238. CSII is also available on microfiche from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, Va. 22161.The NTIS document number for CSII is PB 82-203290. NTIS will also accept credit card telephone orders. The NTIS order desk number is (703) 487-4650. CSII costs $11.50 in microfiche for shipment within the United States and $23 for shipment elsewhere. Section 8(d) Booklet Available The IAO has a new booklet containing the most fre- quently asked questions, and EPA's answers, about reporting under the TSCA section 8(d) health and safety- rule. Also included in the booklet is a partial list of chemical categories and members of the categories named in the 8(d) rule, which became final on Sep- tember 2, 1982. The rule requires manufacturers and processors to provide EPA with unpublished health and safety information about specific chemicals. The health and safety information will aid EPA's investigation of risks posed by specific chemicals and categories of chemicals. Existing Chemicals Paper Available A paper describing how the TSCA existing chemicals program is being managed is now available. The objec- tives of the existing chemicals program are explained, which include further evaluation of chemicals after test- ing in compliance with section 4 has been completed. The paper is a supplement to the January 1982 "Priori- ties for OTS Operations" report. EPA Samples Submitter-Sanitized PMNs EPA recently performed a spot check of submitter- sanitized PMNs. In a sampling of 50 notices received in October 1982, 21 notices contained one or more confi- dential business information (CBI) items which were not claimed CBI by the submitter. Many of the missed CBI claims could have been caught by the submitter through a more careful checking of the notice prior to filing with EPA. The most frequently missed CBI claims found in submitter-sanitized PMNs are: Inadvertent CBI linkage Chemical identification Production volume Use Inconsistency in CBI claims Incomplete company- sanitized claim Linkage to previously submitted PMN Generally manufacturer identifica- tion, such as site or company per- forming toxicity tests, authorizing official name left on document Parts of chemical identification left in process and/or exposure infor- mation Amounts discussed in exposure or risk assessment which link it to production volume Improper masking or none at all on Federal Register page Same claims not masked through- out the PMN Company-sanitized package con- tains: sanitized PMN, unsanitized attachments: unsanitized PMN, sanitized attachments Reference a previously submitted PMN which contained CBI not claimed CBI in current submission, or non-CBI data could disclose the nature of CBI claims in previous submission Industry Assistance Office (TS 799) Office of Pesticides & Toxic Substances U.S.E.P.A. Washington, D.C. 20460 Official Business Penalty for Private Use $300 First Class Mail Postage and Fees Paid EPA Permit No G 35 THE TSCA CHEMICALS IN PROGRESS BULLETIN ------- |