as. Office of Toxic Substances (OTS) Vol. 6, No. 4 October 1985 INSIDE What's Happening in OTS by Don R. Clay, OTS Director OTS Issues Information-gathering Rule to Support OSW Page 2 OTS Plays Important Role in "Spy Dust" Case Page 2 At Work - Frank Kover Page 2 EPA ASKS OSHA to CONSIDER REGULATING 4,4'-MDA Page 3 EPA FURTHER RESTRICTS PCB TRANSFORMER USE Page 3 PETITION FILED by CHICAGO AREA GROUPS DENIED Page 4 ASBESTOS PUBLICATIONS AID BUILDING OWNERS and CONTRACTORS Page 4 EPA FINES 7 CORPORATIONS Page 4 EPA ACCEPTS CONSORTIUM PLAN to TEST TCEA Page 4 EPA SEEKS VINYL ACETATE HEALTH and SAFETY DATA Page 5 EPA DECIDES NOT TO TEST CARBOFURAN INTERMEDIATES Page 5 ADVISORY URGES MINIMIZING WORKER EXPOSURE to MBOCA Page 8 DATA on ITC CHEMICALS RECEIVED Pa9e 8 FOR YOUR INFORMATION OTS Seeks Data for CHIPs Page 5 OTS Receives 19 Initial FYI Submissions Page 6 EPA Plans TSCA Conference for Small Business Managers Page 8 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 tQ request copies of documents mentioned, write the TSCA Assistance Office (TAO), (TS-799) EPA, Washington, D.C. 20460 fheTAO also has a toll-free telephone number (800) 424-9065. In the Washington D.C. area, or from outside the continental Un!tec| states call (202) 554-1404. ------- What's Happening in OTS - Don R. Clay OTS Issues Information-Gathering Rule to Support the Office of Solid Waste As many of you already know, TSCA has truly unique information-gathering authori- ties. We can require industry to provide us with available risk data or to perform needed tests. Until recently, we have used these authorities to gather information that OTS needs. As our experience under TSCA has grown, it has become increas- ingly clear that these authorities can also be used effectively to support the informa- tion needs of other EPA programs and other Federal agencies. Our first such rule was proposed last month to support the EPA Office of Solid Waste (OSW) land disposal restriction activities. The TSCA-proposed rule would require industry to provide all available unpublished health and safety studies on 33 chemicals. OSW needs these data to help them decide whether to ban the land disposal of these chemicals. We expect to finalize this rule shortly and to have the available health and safety data in hand by January of 1986. OTS is prepared to meet future data needs for other programs in the same rapid fashion. OTS Plays Important Role in "Spy Dust" Case Most of you are aware of the recent disclosure by the State Department of the Soviet Union's use of potentially-harmful chemicals to "track" United States personnel in the Soviet Union. Far fewer, I suspect, are aware of OTS's role in support of the State Department. The "spy dust" case, as it was dubbed by the media, illustrates the high calibre scientific capability that OTS has. Several OTS officials along with representatives of the National Institutes of Health were called to the State Department to discuss a chemical substance, 5-(4-nitro phenyl), 4-pentadien-1-AL or NPPD. All we knew was the chemical name and topic of the meeting. In preparation for the meeting, we searched the available data but turned up nothing. Our next step was to have the structure evaluated by the Structure/Activity Team (SAT) in the OTS new chemical program. That is, our experts used available data on chemicals of similar structure to try to predict the chemistry, absorption, reactivity and potential mutagenicity of NPPD—all of this in a matter of a few hours. Clearly, unique capabilities had been applied to this potential problem. Members of SAT along with the OTS staff involved in exposure assessment were called to evaluate the limited data which had been provided by the State Department. Chemistry and minimal toxicology data confirmed concerns raised earlier regarding both reactivity and potential mutagenicity of the substances. This was a case so similar to our every day evaluation of chemicals that it seemed routine. OTS management and staff representatives traveled to Moscow to speak first hand with Embassy personnel and to collect samples to address the questions of magnitude and extent of exposure. "Spy Dust," though not much different from many cases of substances evaluated by OTS, provided an unique opportunity for EPA scientists and management to demonstrate their skills to an alternative and very concerned audience. All who participated should be proud of their role. Frank D. Kover is Chief of the Chemical Screening Branch (CSB) in the Existing Chemical Assessment Division (ECAD). CSB is responsible for information-gathering and initial assessment activities to support the existing chemicals pro- gram in OTS and in other EPA programs. CSB develops TSCA section 8 reporting and recordkeeping rules and section 5 existing chemical significant new use rules in order to obtain data needed by OTS or other EPA offices for risk assessment/ AT WORK management activities. Such rules require manufacturers, importers, and processors of substances and mixtures to report information on use, production, exposure, environ- mental and health effects, disposal, and allegations of signifi- cant adverse reactions to health and the environment. Under Frank's direction, the CSB's staff of about 25 scientists and analysts screen a wide variety of chemical substances. Based on existing information and knowledge of their chemi- cal structure/biological activity relationships, they may iden- tify a limited number that may present potentially significant human health or environmental risks. The sources they use include section 8(e) substantial risk notices, FYI submissions, and information gathered under section 8 rules, as well as the published literature. If a chemical turns out to be of potential concern, Frank's branch may prepare a Chemical Hazard Information Profile (CHIP). Subsequently, the CHIP may be referred to the OTS Risk Analysis Branch for further data- gathering, testing, or assessment within ECAD. (see page 5 for the latest CHIP information). Recent noteworthy activities in CSB include the development of hazard profiles on potential substitute chemicals for sub- stances under consideration in OTS for risk management action and the development of a Comprehensive Assessment Information Rule (CAIR). ------- EPA Asks OSHA To Consider Regulating 4,4'-MDA In July, EPA referred a report on 4,4-methylenedianiline (4,4'- MDA) to the Occupational Safety and Health Administration (OSHA) for possible regulation of the chemical. The report describes the risks of 4,4'-MDA and asks OSHA to respond within 180 days of publication of the notice in the Federal Register (July 5,1985). EPA asked OSHA to make findings of unreasonable risk and of that Agency's authority to prevent or reduce that risk. In the referral notice (50 FR 27674) EPA said based upon the weight of available evidence it classifies 4,4'-MDA as a proba- ble human carcinogen. Because all known exposure to 4,4'- MDA occurs in the workplace, EPA, exercising its referral authority under section 9 of TSCA, gave OSHA prior oppor- tunity to regulate exposures to the chemical. Section 9 pro- vides a mechanism to resolve problems of regulating risks under overlapping Federal laws. About 97 percent of the 400 million pounds of 4,4'-MDA pro- duced in the United States each year is converted directly, in enclosed systems, to methylene diphenyl diisocyanate (MDI). The MDI is used to make polyurethane foams and elastomers. Human exposure is low in the closed system manufacture of 4,4'-MDA and in the preparation of MDI. Higher exposure concerns are for the 3 percent of 4,4'-MDA produced in pure form and packaged for other uses, such as epoxy curing agents, high temperature wire coatings, poly- urethane coreactants, dyes, pigments and defense applica- tions. The higher exposure occur largely from the dust liber- ated in handling pure4,4'-MDA In the non-MDi uses. Exposure occurs from both dermal contact and inhalation. About 600 workers are involved in the manufacture of 4,4'- MDA. However, EPA believes the total exposed population may be as high as 13,000. Six U.S. corporations manufacture 4,4'-MDA, and EPA estimates users may number up to 300 firms. OSHA may respond to the EPA report in several ways. If OSHA does not act or decides that it does not have the author- ity to sufficiently reduce the risk, EPA may then take whatever action it can under its regulatory authorities. If OSHA con- cludes it does have the authority to reduce the risk sufficiently OSHA has three alternatives: • Declare that the risk is not unreasonable. Under the law, this precludes EPA from taking regulatory action. • Decide that the risk is unreasonable and begin regulatory action within 80 days. This precludes EPA from taking regulatory action. • Decide that the risk is unreasonable, but chooses not to begin action within 90 days. In this situation EPA may take regulatory action. Commencement of Manufacture Notices Recently EPA received 39 "Commencement of Manufac- ture" notices for new chemicals and published the list in the August 9,1985 Federal Register (50 FR 32294). Until now the monthly list was reprinted In the Chemi~ cals-in-Progress Bulletin. Beginning with this issue the Bulletin will no longer reprint the list, but the TSCA Assistance Office (TAO) will mail each monthly list to those who call or write the TAO and request that their names be added to the Commencement of Manufac- ture mailing list. EPA Further Restricts PCB Transformer Use On July 17,1985, EPA took action to reduce fire-related risks posed by the use of PCB Transformers, units containing 500 parts per million (ppm) or more of polychlorinated biphenyls. This rule amends portions of the existing PCB electrical equipment rule by placing additional restrictions and condi- tions on the use of PCB Transformers. The rule was prompted by EPA's concern over risks resulting from fire-related incidents involving PCB Transformers in Chicago, San Francisco, and Binghampton, New York. Fires involving PCB Transformers can cause the rupture of the transformer, the release of PCBs, and the formation and dis- tribution of PCBs and toxic incomplete combustion of PCBs. The products formed from the incomplete combustion of PCB dielectric fluid may include 2,3,7,8-tetrachlorodibenzofuran (2,3,7,8-TCDF) and 2,3,7,8-tetrachlorodibenzo-p-dioxin (2,3,7,8-TCDD). When PCB Transformer fires occur in or near buildings, particularly commercial buildings, building occu- pants, as well as emergency response personnel, cleanup crews, and members of the general public, can be exposed and thus are at risk. EPA defines commercial buildings to include all types of buildings other than industrial facilities and would include locations such as office buildings, shopping centers, hospi- tals, and colleges. For the purposes of the rule, a PCB Trans- former located "in or near" a commercial building is defined as one within the interior of a commercial building, on the roof of, attached to the exterior wall of, in the parking area of, or within 30 meters of a commercial building. In the rule (50 FR 29170) EPA: • Prohibits by October 1,1985, further installation of PCB Transformers in or near commercial buildings; • Requires by December 1,1985, the registration of all PCB Transformers with fire response personnel and building owners; • Requires by December 1, 1985, the removal of stored combustibles located near PCB Transformers; • Requires by December 1, 1985, that the access (e.g., vault door, machinery room door, hallway, etc.) to a PCB Transformer be marked; • Prohibits by October 1,1990, the use of higher secondary voltage (480 volts and above) network PCB Transformers in or near commercial buildings; • Requ ires by October 1,1990, the installation of enhanced electrical protection on lower secondary voltage network PCB Transformers and higher secondary voltage radial PCB Transformers in use in or near commercial buildings. EPA also is requiring the owners of PCB Transformers involved in fire-related incidents to notify immediately the National Response Center and to take measures as soon as practicable and safely possible to contain any potential releases of PCBs or incomplete combustion products in water. The July 17, 1985 rule does not have any effect on PCB- Contaminated transformers, which are defined as trans- formers with PCBs in amounts between 50 and 500 ppm. 3 ------- Petition Filed by Chicago Area Groups Denied EPA denied a petition filed by two Chicago-based citizens' groups that asked the Agency to issue a rule under section 4 of TSCA requiring scientific testing of certain substances and mixtures for their combined health and environmental effects. The substances and mixtures were identified as environ- mental pollutants in Southeast Chicago, an area of high industrial concentration. The petition was filed under section 21 of TSCA by the Citizens for a Better Environment and by Irondalers Against the Chemical Threat. The petition, filed on April 23,1985, asked EPA to investigate firms in Southeast Chicago that manufacture, distribute, pro- cess, use or dispose of coke oven emissions, benzene, chrom- ium, arsenic, cadmium, nickel, toluene, xylene, acetone, copper and lead and require them to test for environmental and health effects. For an explanation of citizens' petitions under section 21 of TSCA see page 7. In a July 26, 1985 denial (50 FR 30517) the Administrator said that in order to issue a testing requirement rule under section 4, EPA must specify standards for the development of the test data. To date no standards exist for testing multiple chemicals for their toxicological interactions, and there is not enough scientific knowledge to specify how testing of multiple pollu- tants for their combined health effects should be done or how to ensure that the data from these tests will be reliable. The Administrator said EPA is aware of the importance of considering the potential added health and environmental risks posed by multiple chemical exposures, and that the Agency has ongoing and planned activities to address this area of concern. He cited EPA's "Proposed Guidelines for the Health Risk Assessment of Chemical Mixtures" (50 FR 1170). These guidelines (when published in the fall of 1985) will be useful for the assessment of cumulative risks posed by mix- tures of toxic chemicals such as those cited by the petitioners. However, the Administrator said the available toxicity infor- mation for mixtures on which the guidelines will be based will not allow for the estimation of synergistic or antagonistic effects. Synergistic effects refer to total effects being greater than the sum of the effects taken independently. Antagonistic effects refer to the interaction of two or more chemicals com- ing together. Asbestos Publications Aid Building Owners and Contractors OPTS is distributing two publications to aid building owners and custodians in the inspection, evaluation, and control of asbestos hazards in buildings. The first publication, "Guidance for Controlling Asbestos- Containing Materials in Buildings" will help building owners set priorities in dealing with asbestos-containing materials. The document, informally called the "Purple Book," is a revi- sion of the 1983 "Guidance for Controlling Friable Asbestos- Containing Materials in Buildings." A second document, "Asbestos In Buildings: Guidance for Service and Maintenance Personnel," is designed for custo- dians and other building workers to become familiar with types of materials that could contain asbestos and safe work practices to employ in dealing with those materials. EPA is working closely with the Service Employees International Union and other labor groups to distribute the booklet. EPA Fines Seven Corporations In July EPA fined seven corporations for failing to comply with the reporting requirements of section 8(a) of TSCA. Six of the violations involved asbestos reporting failures. The violations all took place in 1982. The Ford Motor Co., the seventh corporation, was fined $25,000 for failing to file a required TSCA report on an imported chemical. "The reporting requirements of the Act (TSCA) are the founda- tion of EPA's chemical regulatory activities," said Dr. John A. Moore, Assistant Administrator for Pesticides and Toxic Sub- stances. "Without such data EPA cannot act to protect the public from potentially dangerous su bstances. That is why we take these violations so seriously." The six firms fined for violating TSCA asbestos rules are the Raymark Corp., of Trumbull, Connecticut, $25,000 for report- ing two years late on how it used its asbestos; Empire Ace Insulation Manufacturing Corp., of Brooklyn, New York, $25,000 for failing to file an asbestos report; Allpax Company, Inc., of Mamaroneck, New York, $25,000 for failing to report its asbestos manufacturing and use activities for two years; Atlantic Gasket Inc., of Philadelphia, $25,000 for failure to meet asbestos reporting requirements; Economy Die and Gasket Company, Inc., of Baltimore, $10,000 for failure to meet asbestos reporting requirements; Phelps Packing and Rubber Co., of Baltimore, $25,000 for failing to meet asbestos reporting requirements. Persons violating provisions of TSCA may be fined up to $25,000 a day for each day a violation continues. When deter- mining the size of a penalty, EPA takes into account the circumstances surrounding the violation and the number of days the violation existed. Once a civil complaint is issued by EPA, a company may contest the facts in the complaint or the size of the penalty. EPA will reduce the penalty if a firm can provide documentation showing an inability to pay or an inability to continue the business upon payment. EPA Accepts Consortium Plan to Test Toxic Effects of TCEA EPA is proposing that an industry consortium's protocols and schedule submitted for testing the toxic effects of 1,1,1- trichloroethane (TCEA) be adopted as the test standards for the chemical. The EPA August 7, 1985 proposed rule (50 FR 31895) is an outgrowth of a section 4(a) rule published on October 10, 1984 requiring testing of TCEA for developmental^ toxic effects. The consortium, known as the Halogenated Solvents I ndustry Alliance (HSIA) will conduct a full developmental toxicity study on rats and rabbits, as proposed by EPA. The studies will be conducted in accordance with TSCA's Good Labora- tory Practice Standards. The HSIA consortium includes Dow Chemical Co.; ICI America, Inc.; PPG Industries, Inc.; and Vulcan Materials Co. I n 1981, TCEA (71-55-6) was designated by the ITC for prior- ity testing consideration under section 4 of TSCA. For an explanation of section 4, see page 7. '4 ------- EPA Seeks Unpublished Data on Vinyl Acetate On August 8,1985, EPA proposed a rule that would require past, current and prospective manufacturers, importers and processors of vinyl acetate to provide EPA with lists and copies of unpublished health and safety studies on the chem- ical (50 FR 32095). Vinyl acetate is a major industrial chemical. It is prepared from petrochemicals and polymerized and copolymerized with other monomers to produce a wide var- iety of plastics and resins. EPA estimates the current annual production of vinyl acetate at 1.9 billion pounds and importa- tion at 15 million pounds. People are exposed to vinyl acetate during its manufacture, importation and processing as well as from the use of consumer products made of vinyl acetate polymers. The Agency will use the information to support a detailed assessment of the health and environmental risks of vinyl acetate. For additional information on section 8(d), see page 7. EPA Decides Not to Test Carboturan Intermediates EPA is not initiating rulemaking at this time to require testing of carbofuran intermediates (CIs). In December 1982 the Interagency Testing Committee (ITC) recommended to EPA that it consider CIs for testing but did not designate that EPA respond within 12 months. The ITC recommended chemical fate and environmental effects testing for the CIs. EPA said in a July 22, 1985 notice (50 FR 29761) it did not believe on the basis of available data that there is reason to find that "these chemicals may present an unreasonable risk of injury to the environment" nor did the Agency find "that there is or may be substantial environmental release." The three chemicals in the CI group are: • Methallyl-2-nitrophenyl ether (NINE) 13414-54-5 • 7-Nitro-2,2-dimethyl-2,3- 13414-55-6 dihydrobenzofuran (NDD) • 7-Amino-2,2-dimethyl-2,3- 68298-46-4 dihydrobenzofuran (ADD) The ITC recommended chemical fate testing for the CIs with emphasis on environmental monitoring. The ITC said there was insufficient Information to characterize the nature of dis- persion concentration and persistence of CIs in the environ- ment. The environmental effects testing recommended by the ITC included acute toxicity to fish and aquatic Invertebrates. The ITC said that concentrations of CIs in wastewater effluent released to the aquatic environment were believed to approach the concentrations of CIs reported to cause acute effects in goldfish and possibly exceed levels for more sensi- tive species. In evaluating the ITC's testing recommendations for the CIs, EPA considered all available relevant information including production volume, use, exposure and release information reported by the only manufacturer of CIs In the United States. That manufacturer, FMC Corporation, gave EPA its CIs pro- duction volumes for 1982 on a confidential business informa- tion basis. FMC produces CIs only at a Baltimore, Maryland, Plant, and the production Is used as intermediates. For an explanation of the testing under section 4 of TSCA and the role played by the ITC. see page 7. OTS Seeks CHIP Data OTS is asking the public for unpublished information about the following chemical: Hexafiuoroisobutyiene 382-10-5 This chemical has been selected for preliminary assessment review. OTS has preliminary information about potential effects of this chemical to health and the environment and is doing a review to find what other information is available about this chemical. Information should be sent to: TSCA Document Control Office (TS-793) ATTN: Mr. Terry O'Bryan U.S. Environmental Protection Agency Washington, D.C. 20460 Persons who have unpublished data about the chemical, but who also want answers to questions prior to responding should contact John Leitzke of the OTS Chemical Screening Branch, (202) 382-3507, as soon as possible. All information submitted in response to the solicitations will be placed in a public file and made available for public inspec- tion, unless the submitter is able to assert a claim of confiden- tiality, in accordance with the provisions of section 14 of TSCA. EPA will handle all confidentiality claims in accord- ance with its procedures governing the confidentiality of bus- iness information. The OTS review of the chemical, when completed, will be in a report called a Chemical Hazard Information Profile (CHIP). A CHIP is a brief summary of readily available information con- cerning the health and environmental effects and potential exposure to a chemical. CHIP candidates are chosen on the basis of information indicating a potential for adverse health or environmental effects along with evidence of a significant production or some type of exposure. When OTS searches the literature in preparing a CHIP it generally limits the search to automated data bases and refer- ence works. But OTS encourages individuals and firms to submit unpublished or recently published reports and all other hard-to-obtain studies on the chemical selected for a CHIP. Relevant studies from the public coufd include data on health effects, environmental effects, commercial production and uses, exposed populations, environmental levels, or any other material that can aid in theassessment of the chemical's Impact on health or the environment. OTS is also interested in knowing of current testing of a CHIP candidate or assessment activities by other oeg*cUzftttoR8»« The TAO is distributing copies of the recently com- pleted CHIP: Methyl Bromide 74-83-9 OTS encourages comments on the accuracy and tbor* oughness of information presented in the CHIP. The format of the Chemicals-in-Progr&ss Bulletin has changed gradually in 1985. Our aim is to help readers quickly acquire the TSCA information they need. If you have suggestions on how the Bulletin can be improved to help you, please send your ideas to: Joe Boyle Editor Cfremlcals-in-Progress Bulletin TS-789 Washington, DC 20460 5 ------- Latest FYI Submissions EPA received in recent weeks initial FYI (For Your Informa- tion) submissions listed below. For additional information on FYls see page 7. Document Control No. FYI- Chemical Name(s) OTS-0485-0315 Permatox 100 pesticide CAS No. Mixture Case history associated with occupational exposure OTS-0585-0407 S Halogenated pyridine compounds Summarized final results from a probe teratogenicity study in rats Confidential AX-0685-0410 NEODOL alcohols and derivatives Information bulletins on human and aquatic safety/ hazards of a surfactant class Several AX-0685-0411 Light catalytic cracked distillate 64741-59-9 Final report of inhalation acute toxicity tests in rats OTS-0685-0412 4,4'-Methylenebis (benzenamine) polymer 67786-32-7 with methyl oxirane Final reports from a battery of genotoxicity tests AX-0685-0413 Acetaldehyde Carbon tetrachloride Final report from a 4-week inhalation toxicity test in rats using interrupted and uninterrupted exposures OTS-0685-0414 Hydrogen chloride Final report from a 90-day inhalation toxicity test in rats and mice OTS-0685-0415 Methacrylic acid Final report from a 90-day inhalation toxicity test in rats and mice OTS-0685-0416 Benzene Final report from acute inhalation tests in rats and mice to determine genotoxicity AX-0685-0417 Unleaded gasoline Report from an epidemiology feasibility study AX-0685-0418 Petroleum refinery chemicals Report from an epidemiology feasibility study OTS-0685-0419 Very fine diameter fibrous glass Summarized results from an intraperitoneal study in rats to determine carcinogenic effects OTS-0685-0420 S An R&D pesticide Confidential Preliminary results from a 2-year dietary oncogenicity and chronic toxicity study in mice 75-07-0 56-23-5 7647-01-0 79-41-4 71-43-2 8006-61-9 Unknown Unknown OTS-0685-0421 Polychlorinated styrenes Information for CHIP in preparation OTS-0685-0422 Triphenyl phosphite 101-02-0 Information for CHIP in preparation OTS-0785-0423 Elemental yellow phosphorus 7723-14-0 Summarized final results from a one generation gavage reproductive study in rats OTS-0785-0424 s-n-Butyldiamidophosphorothioate Unknown Final report from an acute oral toxicity test in rats OTS-0785-0425 Vinylidene fluoride 75-38-7 Preliminary results from a 13-week inhalation toxicity test in rats to determine reproductive and other target organ effects AX-0785-0426 Petroleum refinery streams Several Preliminary report from a lifetime dermal carcinogenicity/chronic toxicity study in mice Section 8(e).. .Substantial Risk Below is a list of recent initial section 8(e) notices placed in EPA's public file. For an explanation of section 8(e) and how copies of notices can be acquired see page 7. Log No. 8EHQ- [CAS No.] 0585-0555 Brominated diphenyloxide with 36483-60-0 bromination ranging mainly from 6 to 9 68928-80-3 bromines per molecule 32536-52-0 per molecule 63936-56-1 Abbreviated final report from an oral rat teratology study 0585-0556 S Complex methacrylate monomer mixtures Results of a 2-week repeated dermal study in rabbits 0585-0557 Oil refinery products 10-year worker retrospective mortality study report 0685-0558 S Substituted oximidoalkane Final results of a battery of in vitro genotoxicity studies 0685-0559 S T ris(dlmethylamino)silane 15112-89-7 Results of new and previously conducted acute inhalation toxicity studies in rats 0785-0560 Acrylamlde monomer Preliminary results from an ongoing 2-generation reproduction/dominant lethal study In rats 0785-0561 1 -Ethenyl-2-pyrrolidinone Results of several in vitro and in vivo toxicity studies 79-06-1 88-12-0 29082-74-4 61225-61-0 S at the end of a Log Number means a sanitized version is available 6 ------- Below are explanations of sections of TSCA that are cited in this issue of the Bulletin. For additional information about TSCA's provisions, call (800) 424-9065 or write the TAO. Testing ol Chemical Substances and Mixtures.. .Section 4 Section 4 of TSCA gives EPA authority to require manufac- turers or processors of chemicals to test the toxic effects of a designated substance. To require testing EPA must find that the chemical may present an unreasonable risk; that there are insufficient data available 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 substantial production and exposure to humans or the envi- ronment, 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 for the promulgation of section 4 test rules. Besides recommending, the ITC can additionally "designate" the chemicals, in which case EPA must respond to the desig- nation within 12 months by starting rulemaking under section 4 or giving reasons for not doing so. The ITC can designate up to 50 chemicals or categories of chemicals for testing and must make revisions to this section 4 priority list as needed. The ITC is made up of appointed members from eight Federal agencies, as specified in TSCA. Representatives from six additional Federal agencies serve in a liaison capacity. For Your Information For Your Information (FYI) submissions are notices submit- ted voluntarily to the Agency or the Office of Toxic Substan- ces on chemical toxicity and/or exposure. FYls are submitted by chemical manufacturers, processors and distributors, trade associations, labor organizations, Federal, State and local agencies, foreign governments, academia, public inter- est and environmental groups, as well as the general public. Microfiche copies of these submissions are located in the OTS Public Reading Room, first floor, East Tower, Waterside Mall, 401 M Street, S.W., Washington, D.C. To obtain a copy of an FYI, follow the procedure outlined above for TSCA section 8(e) submissions. Health and Safety Data Reporting.. .Section 8(d) Section 8(d) ol TSCA authorizes EPA to promulgate rules on speciiic chemicals and categories of chemicals that require manufacturers, importers, and processors to submit lists and copies of health and safety studies that they initiate or con- duct, know about or can reasonably discover. Section 8(e)...Substantial Risk Under section 8(e), persons who obtain new information that reasonably supports the conclusion that a substance which they manufacture, import, process or distribute presents sub- stantial risk of injury to human health or the environment must notify EPA within 15 working days. These notices are then reviewed by the Office of Toxic Substances (OTS) and an initial evaluation (status report) is prepared containing, if appropriate, followup questions to the submitter, referrals to other agencies, and recommended OTS/EPA followup actions. The 8(e) notices represent a company's first review of a situation and a judgment in compliance with the statute to submit a notice within 15 working days of obtaining the infor- mation. See page 6 for the latest section 8(e) notices. EPA publishes its status reports to make 8(e) information widely available and understandable to a broad public. The submissions and status reports are located in the OTS Public Reading Room, first floor, East Tower, Waterside Mall, 401 M Street, S.W., Washington, D.C. Persons wishing to obtain a copy of a section 8(e) notice may write: EPA, Freedom of Information, Ms. Jeralene Green, (A- 101). Washington, DC, 20460. There is no charge forduplicat- ing the first 49 pages, but at page 50 of a request for duplication there is a $10.00 fee and a 20 cent charge for each additional page (e.g., 51 pages cost $10.20). Single copies of the section 8(e) status reports (not the full submission) are available from the TAO. Citizens' Petltion...Sectlon 21 Any person may petition the EPA Administrator to begin a proceeding for the issuance, amendment or repeal of a rule or order under sections 4,5,6, or 8 of the Act. The Administrator may hold a public hearing, conduct an investigation or pro- ceeding to determine if the petition should be granted. If granted, EPA must begin promptly an appropriate proceed^ Ing. If denied, EPA must publish in the Federal Register the reasons for the denial. If there is a denial, the petitioner may begin a civil action in a Qistrfpt Court to compel EPA to start an appropriate proceeding. The civil action must be filed within 60 days of the Administrator's denial, If the Administra- tor fails to grant or deny the petition within 00 days after the petition is filed, the petitioner may file a civil action with the District Court within 60 days following the expiration of the 90-day response period. 7i ------- OTS Plans TSCA Conference for Small Businesses As the Bulletin was going to press it was learned that the Office of Toxic Substances will sponsor a one-day TSCA Smalt Business Conference, on December 10 or 11, in the greater New Brunswick, New Jersey area. The conference will stress what small business managers must know about TSCA and their obligations to comply with provisions of the Act. If there is enough interest a subsession workshop on the premanufacturing notice provisions of TSCA (PMN section 5) will be held. The workshop will include filling the PMN forms. Preregistration will be required. For more details call the TAO information specialists (800) 424-9065, after November 1, or write: Edward A. Klein, Director, TAO, TS-799, Washington D.C. 20460. Persons interested in an outline of the studies received should read the August 7, 1985 notice. Persons who want copies of the data submissions should write: EPA, Freedom of Informa- tion, Ms. Jeralene Green, (A-101), Washington, DC 20460, There is no charge for duplicating the first 49 pages of a study, but at page 50 of a request for duplication there is a $10.00 fee and a 20 cent charge for each additional page (e.g., 51 pages cost $10.20). For additional information on section 4 and the ITC see page 7. EPA Receives Data on ITC Chemicals EPA recently received test data on six chemicals, all of which are subjects of section 4 negotiated testing programs [August 7, 1985 (50 FR 31919)], Each of the chemicals originally was recommended to EPA for priority consideration for testing by the ITC. The chemi- cals with the approximate n umber of pages of each report are: 2-Chlorotoluene 35 pages 1,3-Dioxolane 30 pages Oleylamine 125 pages Formamide 220 pages 2-Phenoxyethanol 50 pages Tris (2-ethylhexyl) trimellitate 15 pages Advisory Urges Minimizing Worker Exposure to MBOCA A chemical advisory urging manufacturers of polyurethane products to minimize worker exposure to 4,4'methylene-bis (2-chloroaniline) was issued by EPA in June 1983. TheehWW®' ical also known as MBOCA (CAS No. 141-14-4), has been shown to cause cancer in laboratory animals. On the basis of these studies EPA considers MBOCA to be a probable human carcinogen, although available data on cancer in humans are inconclusive, The EPA advisory reports that workers can be exposed through inhalation or ingestion of MBOCA's dust particles or through skin absorption. The advisory recom- mends engineering controls, protective clothing and im- proved work practices. Copies of the MBOCA advisory are available through the TAO. TSCA Assistance Office (TS-799) official Businm Office of Pesticide & Toxic Substances ,0'p,w,wu" U.S.E.P.A. Washington, D.C. 20460 Flnt Clan Mail Portage and Feel Paid EPA Permit No. G-36 THE TSCA CHEMICALS-IN-PROGRESS BULLETIN ------- |