&EPA TSCA Chemicals-in-Progress Bulletin Office of Pesticides & Toxic Substances Vol. 1, No. 1 April 1980 This bi-monthly 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, (TS-799) OPTS, U.S.E.P.A., Washington, D.C., 20460, or call toll-free 800-424-9065 or, in Washington, 554-1404. REGULATORY & REQUIRED ACTIONS CHEMICAL TESTING RULES . . . SECTION 4(a) Section 4(a) rules must specify the chemical, the suspected risk and responsible commercial activity, the insufficiency of data and experience on the risk and the testing necessary to determine the risk. For ITC-recommended chemicals, EPA will publish either a proposed rule or a negative decision document. Both will appear in the Federal Register and have comment periods. TEST DATA STANDARDS . . . SECTION 4(b) Under Section 4(a) EPA must prescribe standards for development of the test data required in the chemical testing rule. Section 4(b) spells out what shall be pre- scribed: how studies are designed and conducted to ensure reliable and adequate data; the time period to do the testing; the persons subject to the rule; and what resources and costs are deemed available and reasonable. A document has been drafted related to Section 4(a) rule-making covering Chloromethane, Chlorinated Benzenes (mono- through penta-) and Acrylamide. The document is undergoing Agency review and is ex- pected to be published in the Federal Register in June. The following testing requirements for health effects are proposed: for Chloromethane, two-year on- cogenicity and morphologic teratogenicity; for selected Chlorinated Benzenes, two-year oncogenici- ty, morphologic teratogenicity, reproductive effects and 90-day subchronic/chronic effects. The Agency is evaluating the need to require environmental effects testing for Chlorinated Benzenes and will subsequent- ly either propose such testing or set forth its reasons for not doing so. For Acrylamide no health effects testing is proposed. The document presents in detail the Agency's reasons for this decision and states that Acrylamide will be the subject of a pre-regulatory assessment based on its neurotoxicity. EPA has published a series of proposals on the follow- ing health effects. These may be considered as model test standards which may be modified when promul- gated for specific chemicals in testing requirement rules under Section 4(a). May 9, 1979, 44 FR 27334: General Requirements for design and conduct of studies Oncogenicity, Non-oncogenic chronic effects and Combined chronic effects Good Laboratory Practices July 26, 1979, 44 FR 44054: Acute oral, dermal and inhalation toxicity; primary eye and dermal irritation; and dermal sensitization Subchronic oral dosing; 90-day dermal and inhalation toxicity Gene mutations, heritable chromosomal mutations, ONA repair or recombination, teratogenicity and reproductive effects General metabolism ------- The comment period for these proposals ended Octo- ber 16, 1979. These TSCA standards will be promul- gated in final form at the same time as the comparable ones under FIFRA. Joint FIFRA/TSCA teams are ana- lysing the comments and striving to make the two sets of standards as alike as possible so as to achieve scientific consistency and similar requirements for those complying with EPA testing. The planned com- pletion dates for this comment/response and final drafting effort are: July for acute effects; August for subchronic effects; and November for the remainder. Other test standards planned for the fourth quarter in 1980 are: selected physical/chemical properties and environmental good laboratory practices. Details on this series of proposals will appear in the Bulletin's next issue. On December 7, 1979, the fifth report of the ITC was published (44 FR 70664). This report added 2 sub- stances and 3 categories with testing specified as follows. Recommended Studies Environ- Human mental Carcino- Terato- Health Epidemi- fate and Substance or category genicity genicity Effects ology effects Benzidine-based dyes x o-Dianisidine-based dyes x x o-Tolidine-based dyes x x Hydroquinone x x x x Quinone x x x REIMBURSEMENT OF TEST COSTS. . . SECTION 4(c) Under Section 4(c), as well as Section 5, there are pro- visions for sharing the costs of testing and equitable reimbursement over a period of time. The law envi- sions a voluntary arrangement among persons subject to a chemical's rule, with EPA acting only when such an arrangement cannot be concluded. A consultation with the Federal Trade Commission is required in promulgating rules for fair and equitable reimburse- ment. On September 18,1979 (44 FR 54284), EPA gave in an Advance Notice of Proposed Rule-making (ANPR) the factors and approaches to be considered in formu- lating a reimbursement rule. The comment period ended February 7,1980. INTERAGENCY TESTING COMMITTEE . . . SECTION 4(e) Under Section 4(e), an Interagency Testing Committee (ITC) was established to recommend to EPA sub- stances which should be tested for specified effects to determine their hazardous potential to human health or the environment. Committee members are: Council on Environmental Quality (CEO), Department of Com- merce (DOC), Environmental Protection Agency (EPA), National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), National In- stitute for Occupational Safety & Health (N/OSH), Na- tional Science Foundation (NSF), and the Occupational Safety 8- Health Administration (OSHA). The commit- tee may list up to 50 chemicals or categories and is to consider revising or adding to its list every 6 months. The EPA must respond within one year to each recom- mendation by initiating rule-making under Section 4 or stating its reasons for not doing so. Both ITC reports and EPA responses appear in the Federal Register. This report brought the total to 23 chemicals and 15 categories for which the ITC has made testing recom- mendations, as given below. A listing with CAS Registry numbers is available from the Industry Assistance Office. Designated for The TSCA Section 4(e) Priority List action by Acetonitrile April 1980 Acrylamide April 1979** Alkyl epoxides October 1978* Alkyl phthalates October 1978* Aniline and bromo, chloro, and/or nitroanilines . .April 1980 Antimony (metal) April 1980 Antimony sulfide April 1980 Antimony trioxide April 1980 Aryl phosphates April 1979** Benzidine-based Dyes November 1980 Chlorinated benezenes, mono-and di- October 1978* Chlorinated benezenes, tri-, tetra- and penta- .. • .October 1979 Chlorinated naphthalenes April 1979** Chlorinated paraffins October 1978* Chloromethane October 1978* Cresols October 1978* o-Dianisidine-based Dyes November 1980 Dichloromethane April 1979** 1,2-Dichloropropane October 1979 Cyclohexanone April 1980 Glycidol and its derivatives October 1979 Halogenated alkyl epoxides April 1979** Hexachloro-1,3-butadiene October 1978* Hexachlorocyclopentadiene April 1980 Hydroquinone November 1980 Isophorone April 1980 Mesityl oxide April 1980 4,4'-Methylenedianiline April 1980 Methyl ethyl kotone April 1980 Methyl isobutyl ketone April 1980 Nitrobenzene October 1978* o-Tolidine-based Dyes November 1980 Polychlorinated terphenyls April 1979" Pyridine April 1979** Quinone November 1980 Toluene October 1978* 1,1,1-Trichloroethane April 1979** Xylene October 1978* •Designated by the Committee In its Rr«t Report and re- sponded to by the Administrator in 43 FR 50134-60138. ** Designated by the Committee in its Second Report and responded to by the Administrator in 44 FR 28095-28097. 2 ------- On March 5, 1980, the Agency submitted a compli- ance schedule for the first three ITC lists as required by the Court of the Southern District of New York. This is the result of a ruling in favor of the Natural Resources Defense Council (NRDC) which sued EPA for non-compliance with Section 4(e) by virtue of not having initiated rule-making within the one year dead- lines. On March 28th intervenors in the case present their comments on the schedule, and, on April 11th, NRDC presents its comments on all submissions to the court. Section 4(a) Schedule—EPA Affidavit, 3/5/80 Health Effects Environmental Effects 1st ITC List ANPR PR ANPR PR Alkyl Epoxides 12-81 9-82 12-81 12-82 Alkyl Phthalates 12-81 12-82 12-81 12-82 Chlorobenzenes (mono & di) — 6-80 9-81 8-82 Chloromethane — 6-80 9-81 8-82 Chloroparaffins 12-80 12 81 2-81 12-81 Cresols 12-81 12-82 12-81 12-82 Hexachlorobutadiene 12-81 12-82 12-81 12-82 Nitrobenzene - 2-81 — 2-81 Toluene 12-81 12-82 12-81 12-82 Xylene 12-81 12-82 12-81 12-82 2nd ITC List Acrylamide — 6-80 9-81 8-82 Aryl Phosphates 12-80 12-81 12-80 12-81 Chloronaphthalenes 12-80 12-81 11-80 12-81 Dichloromethane _ 2-81 — 2-81 Haloalkylepoxides 1-81 4-84 1-82 4-84 Polychlorinated Terphenyls 1-82 4-84 1-82 4-84 Pyridine 1-82 4-84 1 82 4-84 1,1,1 -T richloroethane - 2-81 - 2-81 3rd ITC List Chlorobenzenes (tri-penta) 6-80 9-81 8-82 Dichloropropane 1-82 4-84 1-82 4-84 Glycidol Group 1-82 4-84 1-82 4-84 ANPR = Advance Notice of Proposed Rule-making PR = Proposed Rule-making All dates may refer to an FR notice of a decision not to require testing. The following ITC reports and EPA responses have ap- peared to date: ITC Report Date in FR FR Reference 1 Oct. 12, 1977 42 FR 55026 2 Apr. 19, 1978 43 FR 16684 3 Oct. 30, 1978 43 FR 50630 4 Jun. 1,1979 44 FR 31866 5 Dec. 7, 1979 44 FR 70664 EPA Response To 1 Oct. 26, 1978 43 FR 50134 To 2 May 14,1979 44 FR 28095 PREMANUFACTURE NOTIFICATION (PMN) . . . SECTION 5 Under Section 5(a)(1) a person who intends to intro- duce into commerce a chemical substance not on the TSCA Inventory must notify EPA at least 90 days before beginning manufacture. This rule would apply also to importers. The notice must give the chemical identity, production volume, uses, byproducts, occu- pational exposure and other health and environmental effects information in the submittor's possession. EPA is to use the review period to determine if the sub- stance might present an unreasonable risk that should be remedied through either an order to develop suf- ficient information or an immediately effective rule. Upon such a determination, EPA issues an order to prohibit manufacture and then applies to the court for an injunction to this effect. This order must be issued 45 days before the notification period ends. The original period may be extended by EPA for up to 90 days for good cause noted in the Federal Register. Ab- sent such an order or immediate rule, the manufac- turer may proceed with his plans. EPA publishes in the Federal Register a summary of each PMN five days after its receipt and a status report on all current receipts at the beginning of each month. On January 10, 1979, EPA proposed a rule for Pre- manufacture Notification (44 FR 2242), and on October 16th the Forms for PMN were re-proposed (44 FR 59764) based on comment received. On May 15th (44 FR 28564) an interim policy statement was published to guide submittors until a final rule is promulgated. Copies of the revised proposed Forms for manufac- turers, importers and exporters are available from IAO for use by submittors. A final rule is expected in 11980. 3 ------- EPA's procedure for review of each PMN consists of the following steps. A notice manager is assigned to each PMN who has overall responsibility to see that a proper evaluation is done as quickly as possible. A pre- liminary screening is made within 35 calendar days which includes a profile of the company-submittor, a search of the chemical literature, an engineering re- view of the production process, and assessment of ex- posure and health and environmental effects. A man- agement review of this preliminary screening results in (1) dropping all further evaluation because no unreas- onable risk is foreseen, (2) taking no further action other than follow-up on a few minor points, or (3) undertaking a more thorough assessment toward a possible Section 5(e) order to prohibit manufacture pending development of additional information. During 1979, a total of 37 PMN's and 3 requests for test marketing exemptions (TME's) were received by EPA. Of these, no regulatory action has been taken on the 12 PMN's and 2 TME's whose review period has expired. The 37 PMN's came from 21 companies, both small and large. Significantly, over 20 of the new chemicals were polymers intended for uses such as adhesives, plastics, etc. On February 25, 1980, EPA published the following status report on PMN's received or acted upon dur- ing January (45 FR 12295). Earlier status reports may be requested from I AO. JANUARY 1980 PMN STATUS REPORT PMN No. Identity/Generic name FR citation Expiration date I. Premanufacture Notices Received During the Month 5AHQ-0180-0096 Generic name: 3-Alkoxy (C10-C14)-2-hydroxypropyl ester of dimer/ 45 FR 3967 Apr. 1, 1980. trimer acids (fatty ester). (1/21/80). 5AHQ-0180-0099 Fatty acid, tall oil, epoxidized mixed Cj-Cg alkyl ester 45 FR 6999 Apr. 8, 1980. (1/31/80). 5AHQ-0180-0032A Neopentyl glycolcyclohexane-dimethanol-trimethylpropane-O- 45 FR 6833 Apr. 15, 1990. phthalate-adipate. (1/30/80). 5AHQ-0180-0051A Generic name: Dialkyl (C12-C14) substituted polycarboxylate do Do. 5AHQ-0180-0105 Polyester with dipropylene glycol of byproduct from manufacture of ....do Do. the dimethyl ester of 1,4-benzenedicarboxylic acid. 5AHQ-0180-0111 Polymer of dehydrated castor oil, trimethyloethane, phthalic anhy- In preparation Apr. 28, 1980. dride, and benzoic acid. 5AHQ-0180-0112 Generic name: Substituted-N-alkylquinoline do Apr. 20, 1980. 5AHQ-0180-0113 Generic name: 1,2-Disubstituted-4,5-dimethoxybenzene do Do. 5AHQ-0180-0114 Generic name: Substituted ketone pyran do Do. 5AHQ-0180-0115 Generic name: Monosubstituted-4,5-dimethoxy phenyl ethanol do Do. 5AHQ-0180-0116 Generic name: Monosubstituted-4,5-dimethoxy benzyl chloride do Do. 5AHQ-0180-0117 Generic name: Tetrasubstituted quinoline do Do. 5AHQ-0180-0118 Generic name: Tetrasubstituted-N-alkyl quinoline do Do. 5AHQ-0180-0119 Generic name: Trisubstitutedacetophene do Do. 5AHQ-0180-0128 Stearyl stearamide do Apr. 21, 1980. 5AHQ-0180-0131 Anhydro 3,10-bis(2-(4-(3-pyrodinio)-6-(2,5-disulfophenylamino)- do Do. 1,3,5-triazin-2-ylamino) ethylamino)-6,13-dichloro-4,11-disulfotri- phenodioxazine dihydroxide, hexasodium salt. 5AHQ-0180-0133 1-p-Nitrobenzoyl-1-(4'carboxypyridyl) hydrazide do Do. 5AHQ-0180-0134 Polymer of fumaric acid, isophthalic acid, adipic acid, neopentyl do Do. glycol, diethylene glycol, and propylene glycol. 5AHQ-0180-0034A Generic name: Polymer of alkyl amino methacrylic acid ester, alkyl do Apr. 27, 1980. acrylate, and alkyl methacrylate. 5AHQ-0180-0137 Copolymer of methacrylic acid and diacetone acrylamide do Apr. 28, 1980. II. Premanufacture Notices Received Previously and Still Under Review at the End of the Month 5AHQ-1179-0007A Alkyl hydroxymethyl alkanediol polymer with chloromethyi oxirane 44 FR 70216 Feb. 13, 1980. alkenoate. (12/6/79)' 5AHQ-1179-0010A 2-Ethyl hexyl-2-propenoate polymer with 2-methyl-2-propenoate and do Do. alkyl-2-propenoate. 5AHQ-1179-0070 Claimed Confidential 44 FR 76885 Feb. 14, 1980. (12/28/79). 5AHQ-1179-0073 1,3-Benzenedicarboxylic acid, polymer with E 2-butenedioic acid, 44 FR 70921 Feb. 21, 1980. 1,2-propanediol, and 1,3-butadiene. (12/10/79) 5AHQ-1179-0074 1,3-Benzenedicarboxylic acid, polymer with E 2-butenedioic acid, —do Do. 1,2 propanediol, and 1,3 butadiene acryionitrilie. 5AHQ-1279-0039A Polymer of styrene, 2-ethylhexyl methacrylate, isobutoxymethyl 45 FR 1676 Mar. 5, 1980. acrylamide, dimethylaminopropyl methacrylamide. (1/8/80) 5AHQ-1279-0076 Generic name: 4-Amino-N-substituted benzene sulfonamide do Mar. 9, 1980. 4 ------- 5AHQ-1279-0079 Polymer of phthalic anhydride, ethylene glycol, heptanol, and 44 FR 76856 Mar. 12, 1980. 2-ethylhexanol. (12/28/79) 5AHQ-1279-0080 Polymer of phthalic anhydride, 1,2-propylene glycol, 1,4-butanediol, ....do Do. 1-octanol, and 1-decanol. 5AHQ-1279-0081 Polymer of phthalic anhydride, ethylene glycol, heptanol, 1-octanol do Do. and 1-decanol. 5AHQ-1279-0082 Polymer of phthalic anhydride, 1,2-propylene glycol, 1,4-butanediol do Do. and 2-ethylhexanol. 5AHQ-1279-0083 Polymer of phthalic anhydride, 1,3-butylene glycol, 1-octanol, and 44 FR 76856 Mar. 12, 1980. 1-decanol. (12/28/79) 5AHQ-1279-0084 Polymer of phthalic anhydride, 1,3-butylene glycol, and 2-ethyl- do Do. hexanol. 5AHQ-1279-0077 Magnesium acrylate 45 FR 1674 Do. (1/8/80). 5AHQ-1279-0O57A Polymer of 5-substituted-1,3-benzenedicarboxylic acid; ethylene 45 FR 2387 Mar. 17, 1980. glycol; and e-caprolactone. 5AHQ-1279-0059A Polymer of 5-substituted-1,3-benzenedicarboxylic acid; 1,4-cyclo- ....do Do. hexanedimethanol; ethylene glycol; e-caprolactone; tolylene-2,4- diisocyanate; and 2-butenedioic acid. 5AHQ-1279-0060A Polymer of 1,4-cyclohexane dimethanol and 2-butenedioic acid do Do. 5AHQ-1279-0085 Generic name: Alkenyltrialkoxysilane do Do. 5AHQ-1279-0086 1,3-benzenedicarboxylic acid, a polymer with 2,2-dimethyl-1,3-pro- 45 FR 2387 Mar. 17, 1980. panediol; 2-ethyl-2-(hydroxymethyl)-1,3-propanediol; nonanoic (1/11/80). acid; and 3a,4,7,7a-tetrahydro-1,3-isobenzofurandione. 5AHQ-1279-0087 Generic name: Polyacrylate 45 FR 6159 Mar. 17, 1980. (1/25/80). 5AHQ-1279-0089 Generic name: Amido amine 45 FR 2387 Mar. 26, 1980. (1/11/80). 5AHQ-1279-0088 Generic name: Ring halogenated cyclic dicarboxylic salt 45 FR 3967 Apr. 1, 1980. (1/21/80). III. Premanufacture Notices for Which the Notice Review Period Has Ended During the Month 5AHQ-1079-0035 2-tert-Butvl-4-sec butvlphenol 44 FR 59954 Jan. 1, 1980. (10/17/79). 5AHQ-1079-0037(A) Dodecenyl succinic acid mono alkylester 44 FR 65673 Jan. 27, 1980. (11/14/79). IV. New Chemical Substances That EPA Has Added to the Inventory During the Month None. REGULATION OF HAZARDOUS SUBSTANCES . . . SECTION 6 Under Section 6, EPA may find that a chemical will present an unreasonable risk to human health or the environment and, thus, must be controlled as a hazar- dous substance. EPA may apply one or more of the following controls to the extent necessary adequately to protect against the risk, using the least burdensome requirement and balancing social and economic fac- tors, including benefits and substitutes' availability: prohibit or limit production or distribution or the amount handled; prohibit or limit the use of concentra- tion or the amount used; require marking with warn- ings or instructions for handling; require record- keeping of production processes, monitoring or test- ing for compliance; regulate disposal. AH rule-making must include hearings with an opportunity for cross- examination if required. Labeling Under the authority of Section 6(a) a proposal now in draft would require all manufacturers and importers (including those who repackage and relabel) to deter- mine the hazard of all their chemical substances and mixtures and prepare and affix labels for all their con- tainers used in commerce. A hazard is defined to in- clude substances which are carcinogenic, highly toxic, toxic, corrosive, irritants, sensitizers, extremely flam- mable, flammable, combustible, pyroforic, reactive, strong oxidizers, asphyxiants or compressed gas. For each type, a label text and hazard class (Danger, Warn- ing, Caution) is specified. A staggered schedule would require compliance for carcinogens after one year, other hazards after two and mixtures after three years. Details will appear in the next issue. Asbestos A workshop-style conference will be held July 14-16 at the Sheraton-National Hotel, Arlington, Va. on the question of substitutes for Asbestos; it will be open to anyone interested. IA0 will publicize it during the next two months. 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 human health or the environment must notify EPA witNn IB days. These notices are then reviewed by OPTS pre- liminarily and an initial evaluation is prepared contain- 5 ------- ing follow-up questions of the submittor, referrals to other agencies and decisions to list the chemical for a Section 8 reporting rule or to undertake a formal risk assessment in OPTS. The submissions, often exten- sive, and the OPTS initial evaluations are in the Public Reading Room, 447, East Tower, Waterside Mall, 401 M Street, S.W., Washington, D.C. As of January 1980, 323 Section 8(e) notices have been received. The initial evaluations for the period January 1977 through June 1979 will be published in the second quarter of 1980. This compilation will have several indices for convenient reference by persons in the chemical business to aid them in interpreting and understanding their obligations under Section 8(e). SECTION 8(e) NOTICES OF SUBSTANTIAL RISK: June-December 1979 Log No. 8EHQ- [CAS No.l 0679-0291 6/4/79 Trimethyl Phosphite [125-45-9] "Interim Report on Mutagenicity Study (Ames) "Interim Report on Subacute Inhalation Toxicity Study -0291A 6/27/79 "Interim Report on Teratogenicity Study -0291 Supp. 12/4/79 "Final Report on 6/4 and 6/27 Studies "Preliminary Report on Replicate Mutagenicity & Toxicity Studies 0779-0292 6/22/79 Epichlorohydrin & Uncured Epon 828 "Occupational Report on Worker Exposure (Air) 0779-0293 7/2/79 n-Alkyl Glycidyl Ethers with Alkyl Groups (C2-C10) "Preliminary Report on Mutagenicity Study (Ames) "Preliminary Report on Inhalation, Oral & Intraperitoneal Acute & Subchronic Percutaneous Toxicity Studies -0293 Supp. 12/4/79 "Final Report of 7/2 Studies 0779-0294 7/18/79 Morpholine Nitrates & Nitrosating Agents "Preliminary Report on Mutagenicity Study (Ames) -0294 Follow-up 2/13/80 "Final Report on 7/18 Study 0779-0295 7/9/79 Direct Black 38 Dye [1937-37-7] "Preliminary Report on Skin Absorption Study (Animal) -0296 Follow-up 11/13/79 "Final Report on 7/9 Study (Also Direct Black 19) 0779-0296 7/18/79 Ethyltriphenylphosphonium Acid Acetate, Tetrabutylphos- phonium Acid Acetate, Benzyltriphenylphosphonium Chloride, Ethyltriphenyl- phosphonium Iodide "Final Report on Acute Oral, Dermal Er Eye Toxicity Studies 0779-0297 7/16/79 Solvent Refined Coal (SRC-11) Heavy Distillate "Interim Report on Chronic Toxicity Study -0297 Follow-up 11/12/79 "Interim Report on 7/16 Study -0297 Supp. 2/14/80 "Interim Report on 7/16 Study 0779-0298 VOIDED 0779-0299 7/23/79 Furadan [1563-66-2] [Active Ingredient: Carbofuran] "Uncontrolled Environmental Release: Aerial Spill 0879-0300 8/2/79 Acrylonitrile "Uncontrolled Environmental Release: Spillage 0879-0301 8/13/79 Number Two Home Heating Oil "Interim Report on Mutagenicity Study (Ames) -0301 Supp. "Interim Report on Mutagenicity Study (Ames) 0879-0302 VOIDED 0879-0303 VOIDED 0879-0304 7/26/79 Polyvinyl Fabrics, Cements, Zinc Stearate, Toluene, Heptane, MEK, 1205 Solvent, 1288 Solvent "Employee Report on Occupational Exposure 0979-0305 9/13/79 Ethylene Oxide [75-21-8] "Preliminary Report on Chronic Toxicity Study -0305 Supp. A 10/6/79 "Preliminary Report on 9/13 Study -0305 Supp. B 6/9/79 "Preliminary Report on 9/13 Study 0979-0306 9/14/79 Experimental Pyrolysis Fuel Oil Fraction (From Texas Lignite). Experimental Pyrolysis Untreated Fuel Oil Fraction (From Arkansas Lignite), Experimental Distillate Fuel Oil (From Direct Liquefaction of Wyoming Sub-Bituminous Coal), Experimental Distillate Fuel Oil (Same as Previous Item) "Interim Report on Carcinogenicity Study 0979-0307 VOIDED 0979-0308 VOIDED 0979-0309 VOIDED 0979-0310 9/14/79 Trichloroethylene & Other Volatile Organic Chemicals "Preliminary Report on Water Monitoring Study 0979-0311 9/21/79 Mixture Containing Dialkyl Diglycol Carbonate "Interim Report on Acute Eye Toxicity Study 0280-0312 2/5/80 Isopar C & Varsol 40 "Final Report on Subchronic Inhalation Toxicity Study 1079-0313 VOIDED 1079-0314 10/19/79 Formaldehyde "Preliminary Report on Chronic Toxicity Study •0314 Supp. A 1/24/80 "Interim Report on 10/19 Study -0314 Supp. B 1/31/80 6 ------- •Interim Report on 10/19 Study 1079-0315 10/23/79 Liquified Combination of Polygard [Tri (mixed mono- and dinonylphenyl) Phosphite] and Argus Q-328 [a thiodi- propionate ester complex] "Employee Report of Occupational Exposure 1179-0316 10/22/79 Experimental Hydrotreated Fuel Oil Fraction from Coal Gasification •Interim Report on Carcinogenicity Study -0316 Follow-up 2/28/80 •Interim Report on 10/22 Study 1179-0317 4/3/79 Kronitex" 50, Kronitex" 100, Kronitex" 200 (Mixtures of Tricresylphosphate & Isoprophenyl Phenyl Phosphates) •Datum: Octanol/Water Partition Coefficient 1179-0318 10/30/79 Strontium Chromate •Preliminary Report on Carcinogenicity Study 1179-0319 11/5/79 Transformer Oil & PCBs •Report of Environmental Release: Spillage 1179-0320 11/13/79 1,4-Dioxane •Data: GLC Results for Ethoxylation 1179-0321 11/15/79 Disperse Turquoise TLF •Final Reports on Mutagenicity Studies (Ames) 1279-0322 12/4/79 Chlorine •Uncontrolled Environmental Release: Air 1279-0323 9/24/79 Jet Fuel A •Final Reports on Mutagenicity Studies (Ames) N.B.: All toxicity, teratogenicity, carcinogenicity and mutagenicity studies involve animals. Additional teats are noted. REPORTING RULES PRELIMINARY ASSESSMENT INFORMATION . . . SECTIONi8(a)-LEVEL A Under Section 8(a) EPA may require manufacturers and processors to submit information on named chemicals of the following types: production, use, oc- cupational exposure, byproducts, disposal and health and environmental effects. The rule only applies to in- formation already in their possession. A "LevelA"rule is meant to gather basic information, not otherwise available, for a preliminary sorting of candidates for TSCA consideration under either Section 4 testing or Section 6 control. Level A is one of three projected types of multi-chemical Section 81a) reporting rules, with Levels B and C representing "genera!" and "detailed" assessment information respectively. On February 29, 1980 (45 FR 13646), EPA proposed the first Section 8(a)-Level A reporting rule covering 2300 chemicals. The comment period ends May 14; in addition to providing written comment, persons may request a meeting with responsible program offi- cials through IA0. Available, besides reprints of the proposal, are the economic impact analysis and small business definition analysis and also a synonyms list for the 2300, which are published in the proposal with the CAS Registry number and TSCA preferred name. The list of 2300 was derived from the following sorts: an early ITC master list for those with high exposure potential plus inclusion on the TSCa Inventory (300); the ITC list for biological activity plus inclusion on the TSCA Inventory; the Inventory for high-volume pro- duction (1700); in-house subjects whose assessment were incomplete because of inadequate available in- formation (including Section 8(e) notices); and, finally, chemicals recommended by the ITC for Section 4 test- ing rules. Manufacturers, importers, miners and, in some cases, processors would be subject to this rule. In another rule-making, EPA plans to propose in Oc- tober of this year a Section 8(a) reporting rule for follow-up of selected new chemicals that have passed through Premanufacture Notification. The likely time in the chemical's life when such a rule would apply is three years after commercialization. SINGLE CHEMICAL REPORTING RULES . . . SECTION 8(a) For chemicals high on the Office's regulatory agenda, often well-characterized and long-standing cases within EPA and OSHA/N/OSH, a single chemical re- porting rule may be promulgated to procure particular data to support particular regulatory options. Asbestos was the subject of an ANPR on October 17, 1979 (44 FR 60061) in which EPA announced its inten- tion to regulate Asbestos under Section 6. To support the analysis of possible controls, a Section 8(a) report- ing rule will be proposed. Many illustrative questions were included in the ANPR, and comment was asked on the feasibility and appropriateness of the queries. Comments were due February 18, 1980. Health and safety study reporting under Section 8(d) for unpub- lished holdings was proposed on December 31st (44 FR 77470). The Section 8(a) proposed rule is planned for July, 1980. HEALTH & SAFETY STUDY REPORTING . . . SECTION 8(d) Under Section 8(d) persons may be required to submit lists and/or copies of health and safety studies that have been conducted by or for them at any time. The purpose of this authority is to secure for EPA data otherwise unavailable. The term "study" means any study of any effect on health or the environment, in- cluding underlying data. Examples are epidemiologi- cal, occupational exposure, toxicological, ecological and clinical studies and any test performed pursuant to TSCA. On December 31,1979 (44 FR 77470), EPA proposed a rule for health and safety study reporting for 61 chemicals (comprising 387 named, discrete sub- stances), most of which are dyes. Firstly, this proposal would require all manufacturers, processors and dis- 7 ------- tributors to submit copies of any final reports they pos- sess of unpublished studies on any chemical listed in the rule. Two alternatives for limiting this copy submis- sion requirement are raised in the proposal: (a) to ap- ply it only to those handling a listed chemical but re- quire them to search and submit for all chemicals listed; or (b) to apply it to those handling a listed chem- ical since 1950 but only for their own products. Sec- ondly, the proposal would require all current manufac- turers etc., to submit only for their own products a list of studies known to them (but not in their possession) and ones currently being conducted by or for them. This obligation to list on-going studies continues for five years after a chemical appears on the Section 8(d) list. All reports would be due 60 days after promulga- tion of a final rule. Underlying data and records is not being asked for. The comment period ends April 14, 1980. Promulgation is expected in September. STUDIES & SUPPORT ACTIVITY CHEMICAL INFORMATION SYSTEM (CIS) The Chemical Information System (CIS), initiated under TSCA by EPA as a joint project with the Na- tional Institutes of Health, now has the TSCA Chemi- cal Substances Inventory on it. This interactive com- puter system is accessible to the public possessing a data processing terminal with an acoustic coupler by signing up with the CIS project manager, Mrs. Pool, at Interactive Sciences Corp. (800-424-9600). There is a $300 per year subscription charge plus various hourly rates for different kinds of searches. N.B.: None of the manufacturer or production information reported to EPA for the inventory is entered on CIS. With the Inventory now entered on CIS, persons may search it by name, name fragments, molecular weight or formula and chemical structures. Through the "Structure and Nomenclature Search System" (SANSS), one can proceed from these elements to the CAS Registry number and other data bases on the system. These include the RTECS-Acute Toxicity Data, X-ray diffraction data, CNMR and mass spectra. The CIS plan includes adding a data base with all the Federal Register citations for all federal authorities regulating chemicals and the public health. INTERAGENCY REGULATORY LIAISON GROUP (IRLG) The IRLG consists of CPSC, EPA, HEW/FDA, USDA/FSQS IFood Safety & Quality Service), DOL/OSHA and aims to optimize coordination among those federal authorities responsible for regulating chemicals and the public health. On January 25, 1980, the Interagency Regulatory Liaison Group published a "Report on IRLG: Recent Accomplishments and 1980/81 Plans" (45 FR 6276). Areas covered were economic analysis, testing stan- dards and guidelines, compliance and enforcement, regulatory development, risk assessment, laboratories and analytical methods, regional coordination, epi- demiology, research planning, information exchange, and public information and education. Previous IRLG reports of importance to the TSCA community are: Scientific Report on Estimating Risk and Potential Carcinogens (44 FR 39858, July 6,1979); Draft IRLG Guidelines on Selected Acute Toxicity Tests (August 1979); and the Draft IRLG Guideline for Epidemiology (September 1979). 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 8 ------- |