\ / -< T~Tv , F1 I TSCA Chemicals-in-Progress r !' k w Bulletin Office of Toxic Substances (OTS) fi tXXZZZ «* M ®«i*' "T ' •*. • vi r,- v : ixiAZi < A i Vol. 8 No. 4 September 1987 INSIDE What's Happening in OTS—By Charles L. Elkins 2 EPA ISSUES BIPHENYL TESTING RULE 6 TESTING OF SOME FLUROALKENES REQUIRED 3 UNION CARBIDE FINED $80,000 2 EPA PROPOSES TESTING FOR DTBP 4 AGENCY SETS TESTING FOR DCBTF 7 ANTHRAQUINONE TESTING AND REPORTING RULE ISSUED 4 EPA SETS HDD AND HDF TESTING AND REPORTING REQUIREMENTS 5 AGENCY ISSUES HYDROQUINONE STANDARDS 7 ITC USING NEW AUTOMATED SCORING SYSTEM 3 EPA PROPOSES AMENDMENTS TO PCB RULE 4 AGENCY DENIES CITIZEN'S PETITION ON PCBs 4 SNUR ISSUED FOR 11-AA 5 FOR YOUR INFORMATION EPA Report on Regulatory Investigation of Formaldehyde 3 OTS Receives 16 Substantial Risk Notices 6 Trichlorobenzenes and Tetrabromobisphenol A 4 Available: TSCA Guide for Chemical Importers/Exporters 7 Chemicals on Reporting Rules Database 6 12 New FYls Available 7 EPA Files Motion to Withdraw Civil Administration Complaint 2 ITC Brochure Available 3 This news bulletin is intended to inform all persons concerned with the Toxic Substances Control Act (TSCA) about recent de- velopments and near-term plans. For further information or to re- quest copies of documents mentioned, write the TSCA Assist- ance Office (TAO), (TS-799) EPA, Washington, D.C. 20460, or call (202) 554-1404. ------- What's Happening in OTS—Charles L. Elkins Suppose you suddenly discovered that a company in a neighbor- ing town was using a chemical believed to be hazardous to your health and that some of this chemical is being released to the air. And suppose some of this same chemical is being released in the company's waste stream to the river from which your community draws its drinking water. What would you do? Complain to EPA or your State? Call the president of the company? Drink bottled wa- ter? Sell your home and move? All of these are possible reactions and you might end up doing one or more of them. As a first step, however, you could do what the scientists in the Office of Toxic Substances do when con- fronted with a similar problem—use sophisticated computer mod- eling systems to predict the potential exposure of people to these emissions. Specifically, you could apply the Graphical Exposure Modeling System (GEMS) to the estimated emissions from the company in order to estimate what the chemical concentrations in the air and water would be by the time the chemical has moved to your community. Many of you may be familiar with GEMS. Over the past seven years while OTS has been developing, expanding, and refining the system, the GEMS user community has grown to greater than 230 people. GEMS users can be found in nearly every EPA pro- gram office, every EPA regional office, six other Federal agen- cies, 21 States, and two European countries. Its popularity results from having many capabilities in a single, integrated system which is easy to use and doesn't require the user to be a com- puter programmer. GEMS contains several computerized tools that are useful in as- sessing exposure of chemical substances released to the en- vironment. These tools include models to simulate the movement of chemicals in the atmosphere, lakes and streams, soils and groundwater aquifers. They also include databases to support the use of these models, methods for estimating properties of organic chemicals, statistical analysis programs, and graphics and mapping packages. Now back to one part of our earlier example community. Using GEMS you can generate a map showing the river that receives the chemical discharge, the location of the discharger and the lo- cation of downstream drinking water facilities. Next, you can esti- mate any missing chemical property information that might influ- ence the behavior of the chem- ical in the river. The river database has the environmen- tal information necessary to describe the river into which the chemical is released; and a component of GEMS automat- ically builds the needed model input files in the proper format. The model is run to estimate the chemical concentrations in the river water at the location of the drinking water intake. Statistical analysis and graphi- cal displays of the model data may be made at this time. After factoring in any additional removal that might be expected to oc- cur from drinking water treatment, the data can be compared with health (toxicity) data to get a better sense of the seriousness of the problem. I haven t mentioned other exposure pathways which may be important, such as eating fish or swimming in the river, but I'm sure you get the idea. The existence and release of a toxic chemical doesn't necessarily constitute a serious problem. What is particularly important to the calculation of the risk to the public is the concentration of the chemical in proximity to the population. Emission data do not provide this parameter, but with GEMS one can make an approx- imation of these concentrations. As OTS prepares to collect yearly emission data from all major manufactures and users of toxic chemicals under section 313 of the Superfund Amendments and Reauthorization Act (SARA), we are seriously considering making GEMS and a personal computer version of GEMS avail- able widely to the public in order to lend support to the public's as- sessment of the significance of these chemical releases to the environment. Without some way to relate these emissions to ac- tual exposure, it will be very difficult indeed for the public to dis- tinguish between really serious toxics problems and less serious ones. We expect the section 313 Inventory will uncover many ap- parently serious toxic problems and it will be important that the public, the States and Federal government be able to distinguish the really serious problems right away. GEMS may provide part of the solution. Access to GEMs is available through EPA and the National Tech- nical Information Service under an account system. If you are in- terested in finding out more about GEMS; please write to me in care of Joe Boyle, Editor, Chemicals-ln-Progress Bulletin, at my office in Washington. Union Carbide Fined $80,000 For Risk-Reporting Violations On July t, 1987, EPA announced that Union Carbide Corp. of Danbury, Conn., agreed to pay a cash penalty of $80,000 and perform a corporate-wide environmental audit to settle an admin- istrative complaint that EPA filed against the company on March 1,1985. In the administrative civil complaint, EPA charged Union Carbide with delaying over four years the reporting of the results of a study that showed that diethyl sulfate caused skin cancer in mice. The $80,000 payment represents the first major penalty ever collected on a risk-reporting violation under TSCA. The cor- porate-wide environmental audit that Union Carbide will perform of its substantial-risk information is the first of this type agreed to in settlement of a TSCA complaint. Any violations discovered by the audit will be subject to civil penalties under TSCA. The settle- ment agreement also incorporates for the first time in an enforce- ment action an alternative dispute resolution mechanism for re- solving technical questions. This mechanism is a tool EPA is now using to resolve disputes. Lonza Inc. On July 10, 1987, EPA filed a motion to withdraw a civil admin- istrative complaint that alleged Lonza Inc. had violated section 8(d) of TSCA, by failing to submit to EPA a short-term air-monitor- ing study. Section 8(d) of TSCA requires chemical companies to submit to EPA copies of unpublished health and safety studies on specific chemicals listed by an EPA rule. The rule requires the re- porting of workplace monitoring studies, but only when the results "have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mix- ture." Lonza's case involves a one-time, one-site atmospheric con- centration sampling which, according to informal EPA guidance, is not the type of test data intended to be required by the section 8(d) rule. In addition to dropping the civil complaint against Lonza Inc., EPA intends to promulgate amendments to the section 8(d) model health and safety data reporting rule to describe more pre- cisely what types of monitoring studies must be submitted. 2 ------- EPA Reports on Its Regulatory Investigation of Formaldehyde The Agency's regulatory investigation of urea-formaldehyde pressed wood products continues its progress as OTS prepares for an EPA options selection meeting presently targeted for the spring of 1988. The pressed wood products under investigation include particleboard, hardwood plywood and medium density fi- berboard that contain urea-formaldehyde (UF) resin which func- tions as a wood adhesive. Since beginning the investigation in May 1984, EPA has reported semi-annually in the Chemicals-in- Progress Bulletin on the progress of the investigation. This is its sixth report. UF pressed wood is widely used as building materials for con- structing manufactured (mobile) and some conventional homes. It is also used as industrial board for manufacturing furniture and cabinetry. Both uses are recognized as important sources of for- maldehyde and contribute to the higher than normal ambient lev- els of the chemical sometimes encountered in new or recently re- modeled indoor environments. With time, high initial levels in homes decay to lower levels as free formaldehyde emissions from these boards decline. At the options selection meeting, EPA decisionmakers will assess the need for, and potential nature of, additional Federal regulations that address formaldehyde emis- sions from these products. Since its last report, EPA has completed and publicly released its 1987 formaldehyde risk assessment. The assessment document was prepared by Agency scientific staff in consultation with EPA's Science Advisory Board, an independent panel comprised of sci- entific experts from outside the Agency. Prepared to serve the needs of the present OTS investigation, the risk assessment will also be used by other EPA programs that are concerned with for- maldehyde exposure from other sources. These programs are administered by EPA's Office of Air and Radiation and the Office of Pesticide Programs. EPA's assessment looked at both the acute and chronic health effects of low-level exposure to the chemical. In terms of acute effects (eye, nose and throat irritation, headaches, nausea and a variety of asthma-like symptoms), it found that people will re- spond at different levels within the range of 0.1 to 1.1 parts per million. With respect to chronic effects, the assessment re- affirmed an earlier classification of formaldehyde as a "Group B1 Probable Human Carcinogen," a classification derived from eval- uating the scientific evidence in accordance with EPA risk as- sessment guidelines. The assessment reports cancer risk esti- mates (including both the "upper bound" and maximum likelihood" estimates) for several exposure conditions. A sum- mary of EPA's formaldehyde risk assessme.it is available from the TSCA Assistance Office. EPA Requires Testing of Some Fluroalkenes On June 6, 1987, EPA issued a TSCA section 4 rule requiring testing for certain health effects for some fluoroalkenes (52 FR 21516). At the same time the Agency withdrew its proposed re- productive effects testing for vinylidene fluoride. The fluoroalkenes covered by this rule are: vinyl fluoride 75-02-3 vinylidene fluoride 75-36-7 hexafluoropropene 116-15-4 tetrafluoroethene 116-14—3 In its seventh report the Interagency Testing Committee desig- nated the chemical category fluoroalkenes for priority testing con- sideration by EPA [November 25, 1980 (45 FR 78432)]. Since then EPA has taken various actions pertaining to fluoroalkenes. ITC Using New Automated Scoring System In 1986, the Interagency Testing Committee (ITC) developed new approaches for the evaluation of several thousand chemi- cals. This automated chemical scoring system is being used to govern the process for selecting chemicals to be reviewed in de- tail by the ITC. Following its detailed review of a chemical, the ITC may recommend the chemical to EPA for priority consideration for testing under section 4 of TSCA. Between 1977 and 1983 the ITC held five "scoring exercises" to select existing chemicals for the committee to review in detail. Those exercises focused on chemicals of regulatory concern, high production chemicals and chemicals recommended by other organizations. The ITC is made up of appointed members from eight Federal agencies as specified in TSCA. Representatives from seven ad- ditional Federal agencies serve in a liaison capacity. In 1986, during the ITC's sixth chemical scoring exercise, new ways of scoring were developed and implemented. Approx- imately 20,000 discrete organic chemicals that are on the TSCA Chemical Substance Inventory were screened to remove inap- propriate chemicals. The remaining chemicals were further ana- lyzed for potential for adverse health and ecological effects and for potential exposure. This process identified 407 chemicals with both effects and exposure potential. An automated scoring step was developed with scores based on effects potential, exposure potential and annual consumption. Implementation of the auto- mated scoring step has been postponed pending completion of the TSCA Inventory update. In the interim, chemicals were se- lected for detailed review at a workshop. Plans to improve the process include adding additional TSCA In- ventory chemicals to the initial list, identifying additional com- puter-searchable descriptors for potential effects and adding ad- ditional monitoring information. "While the new process is in need of considerable improvement and refinement, it should provide the foundation for continuous, automated chemical screening and scoring that can be used by the ITC whenever the need arises to select chemicals for detailed review," said Dr. Robert Brink, the ITC's executive secretary. Persons interested in learning the details may request a copy of the ITC's interim report on the Sixth Scoring Exercise. Page 8 of this issue of the Bulletin contains an explanation of the legal authority for the existence of the TSCA Interagency Testing Committee (ITC). Because of the interest in its work, the ITC re- cently produced a brochure explaining its mission, scope, priority, membership, review policy and process, scoring of chemicals and the chemical nomination process. The brochure can serve as a ready reference when questions arise as to how the ITC func- tions. The TAO is distributing copies of the brochure upon re- quest. ------- EPA Proposes Amendments to PCB Rule On July 8, 1987, EPA proposed (52 FR 25838) to amend the Agency's July 10, 1984 rule on inadvertantly generated poly- chlorinated biphenyls (PCBs) by excluding additional materials from regulation. EPA has determined that activities involving these materials do not present an unreasonable risk of injury to health or the environment. A July 10,1984 rule (called, the Uncontrolled PCB rule) permitted the manufacture, processing, distribution in commerce, and use of inadvertently generated and recycled PCBs under limited cir- cumstances. Specifically, the Uncontrolled PCB rule excluded from the TSCA bans, activities involving less than 50 ppm PCBs which were generated in manufacturing processes which com- plied with the rule's conditions limiting releases to air, water, products, and wastes. After the 1984 rule took effect, some companies and trade asso- ciations filed petitions, under section 19 of TSCA, seeking judicial review of the law. A settlement agreement outlining proposed amendments to the July 10, 1984 rule was reached. The points agreed to are included in the proposed rule issued on July 8, 1987. Specifically, the July 8, 1987 proposed rule would eliminate from the use authorization for PCBs in heat transfer and hydraulic sys- tems the June 10, 1984 requirement that Viton"' elastomer gloves be worn by workers performing maintenance on such systems. The proposed rule also would exclude from the PCB ban on use and distribution in commerce, certain equipment and materials which have been adequately decontaminated. The proposal also would amend the July 8,1984 definition of "re- cycled PCBs." The redefinition would eliminate the condition lim- iting the amount of Aroclor PCBs in water discharges from paper recycling facilities and leave that control to individual NPDES per- mits. Certain restrictions remain on uses of waste oil containing any detectable level of PCBs. The proposal adds a prohibition on burning such oils in small, nonindustrial boilers. The following TSCA rules were issued recently: Trichlorobenzenes On July 1,1987, EPA issued a phase II TSCA rule that specified test standards and reporting requirements for environmental effects testing of 1,2,3- and 1,2,4-tricblorobenzene (52 FR 24460). The CAS numbers for the two chemicals are 87-71-6 and 120-82-1. The chemical fate testing requirements in the phase I rule [April 7, 1986 (51 FR 11728)] have been satisfied and withdrawn. Tetrabromobisphenol A On July 6,1987, EPA issued a test rule requiring manufacturers and processors of tetrabromobisphenol A (TBBPA) to perform testing for chemical fate and environmental effects (52 FR 25219). The testing requirements for TBBPA (CAS No. 79-94-7) include biodegradation studies in sediment/water and soil, an acute toxicity study in freshwater algae, acute and early life stage toxicity studies in fish, a partial life-cycle toxicity study in a benthic invertebrate, a chronic toxicity study in an aquatic invertebrate and bioconcentration studies in fish and invertebrates. EPA Proposes Testing For DTBP On June 25, 1987, EPA proposed that manufacturers and proc- essors of 2,6-di-?ert-butylpenol (DTBP) test for chemical fate and environmental effects (52 FR 23862). The proposed rule was issued in response to an Interagency Testing Committee designation of DTBP for priority consideration for chemical fate, health effects and ecological effects testing [November 19, 1985 (50 FR 47603)]. EPA is not proposing DTBP health effects testing at this time. The Agency concluded that occupational exposures to the chemical are low and intermittent, and fewer than 100 workers are proba- bly involved. After reviewing available data the Agency concludes human exposure to DTBP is extremely low and does not present an unreasonable risk to human health. DTBP (CAS No. 128-39-2) is a crystalline solid that is soluable in many organic solvents. It is produced at sites in New York, South Carolina and California. Annual production is estimated to be 24 to 34 million pounds per year. At least one firm imports DTBP. In the United States, an estimated 75 to 95 percent of all DTBP is used as a synthetic intermediate for the production of higher mo- lecular weight phenolic antioxidants. DTBP is also incorporated into fuels, oils, plastics, rubber and other products as an oxidation inhibitor and stabilizer. DTBP is expected to enter the environment mainly as a result of water releases from sites where the substance is made and used. DTBP is expected to be rapidly oxidized in air. EPA Denies Citizen s Petition on PCBs On July 2, 1987, EPA published the denial of a citizen's petition calling for an amending of the TSCA definition of polychlorinated biphenyls (PCBs); the petitioner wanted mono-, di-, and tri- chlorobiphenyls to be excluded from the definition (52 FR 25068). In denying the petition, filed under section 21 of TSCA, EPA said Congress directed the Agency through section 6(e) of TSCA to eliminate all PCBs from the environment. The Agency said it had addressed the issue of excluding lower chlorinations of PCBs in response to an earlier petition [August 25, 1982 (47 FR 37259)]. In the 1982 denial EPA acknowledged the technical merits claimed regarding the relative risks of monochlorobiphenyls; nev- ertheless, it denied the 1982 petition because of congressional intent to include all chlorinated biphenyls. For addition informa- tion about section 21 of TSCA, see page 8 of this issue of the Bulletin. EPA Issues Testing and Reporting Rule for Anthraquinone On June 4, 1987, EPA issued a TSCA rule requiring manufac- turers and processors of 9,10-anthraquinone (anthraquinone) to perform certain chemical fate and environmental effects testing and to report annually the volume manufactured or imported, dur- ing the latest corporate fiscal year (52 FR 21018). Under TSCA, importers are considered manufacturers. Section 8 of TSCA gives EPA reporting authority, and section 4, testing au- thority. The tests required under the anthraquinone rule are for water sol- ubility, bioconcentration, sediment toxicity to benthic organisms and acute toxicity to acquatic organisms. 4 ------- EPA Sets HDD and HDF Testing and Reporting Requirements Ori June 5, 1987, EPA issued a TSCA rule requiring manufac- turers and importers of 12 organic chemicals to test the sub- stances for the presence of chlorinated and brominated dibenzo- p-dioxins (HDDs) and dibenzofurans (HDFs). HDDs and HDFs are recognized as having potential health and environmental sig- nificance because of their potential for adverse toxic effects at The rule names an additional 29 chemicals as precursors, and re- quires companies which use one of these chemicals as a precur- sor in the manufacture of another chemical to report certain infor- mation to EPA. The precursor chemicals are: very low doses. The rule (52 FR 21412) will require testing of any of 20 additional organic chemicals not currently manufactured or imported into the United States if manufacturing or importation resumes. The rule also requires manufacturers and importers of the 12 chemicals currently available in the United States to submit. • existing test data on HDD or HDF contamination • unpublished health and safety studies on HDDs and HDFs • consumer or worker allegations of significant adverse reactions to HDDs and HDFs. The same reporting information will be required for any of the 20 other chemicals if manufacturing or importation resumes. The 12 chemicals currently manufactured in, or imported into, the United States are: CAS NO CHEMICAL NAME 79-94-7 Tetrabromobisphenol-A 118-75-2 2,3,5,6-Tetrachloro-2-5-cyclohexadiene-1,4- dione 118-79-6 2,4,6-T ribromophenol 120-83-2 2,4-Dichlorophenol 1163-19-5 Decabromodiphenyl oxide 4162-45-2 Tetrabromobisphenol-A-bisethoxylate 21850-44-2 Tetrabromobisphenol-A-bis-2,3-dibromopropyl ether 25327-89-3 Allyl ether of tetrabromobisphenol-A 32534-81-9 Pentabromodiphenyl oxide 32536-52-0 Octabromodiphenyl oxide 37853-59-1 1,2-Bis(tribromophenoxy)-ethane 55205-38-4 Tetrabromobisphenol-A-diacrylate The 20 chemicals not currently manufactured in, or imported into, the United States that are subject to this rule are: 79-95-8 T etrachlorobisphenol-A 87-10-5 3,4,5-T ribromosalicylanilide 87-65-0 2,6-Dichlorophenol 95-77-2 3,4-Dichlorophenol 95-95—4 2,4,5-Trichlorophenol 99-28-5 2,6-Dibromo-4-nitrophenol 120-36-5 2[2,4-(Dichlorophenoxy)]-propionic acid 320-72-9 3,5-Dichlorosalicyclic acid 488-47-1 Tetrabromocatechol 576-24-9 2,3-Dichlorophenol 583-78-8 2,5-Dichlorophenol 608-71-9 Pentabromophenol 615-58-7 2,4-Dibromophenol 933-75-5 2,3,6-Trichloropbenol 1940-42-7 4-Bromo-2,5-dichlorophenol 2577-72-2 3,5-Dibromosaiicylanilide 3772-94-9 Pentachlorophenyl laurate 37853-61 -5 Bismethylether of tetrabromobisphenol-A — Alkylamine tetrachlorophenate — Tetrabromobisphenol-B 85-22-3 Pentabromoethylbenzene 87-61-6 1,2,3-Trichlorobenzene 87-84-3 1,2,3,4,5, Pentabromo-6-chlorocyclohexane 89-61-2 1,4-Dichloro-2-nitrobenzene 89-64-5 4-Chloro-2-nitrophenol 89-69-0 2,4,5-T richloronitrobenzene 92-04-6 2-Chloro-4-phenylphenol 94-74-6 4-Chloro-o-toloxy acetic acid 94-81-5 4-(2-Methyl-4-chlorophenoxy) butyric acid 95-50-1 o-Dichlorobenzene 95-58-7 o-Bromophenol 95-57-8 o-Chlorophenol 95-88-5 4-Chlororesorcnol 95-94-3 1,2,4,5-Tetrachlorobenzene 97-50-7 5-Chloro-2,4-dimethoxyaniline 99-30-9 2,6-Dichloro-4-nitroaniline 99-54-7 1,2-Dichloro-4-nitrobenzene 106-37-6 Dibromobenzene 106-46-7 p-Dichlorobenzene 108-70-3 1,3,5-Trichlorobenzene 108-86-1 Bromobenzene 108-90-7 Chlorobenzene 117-18-0 1,2,4,5-Tetrachloro-3-nitrobenzene 120-82-1 1,2,4-T richlorobenzene 348-51-5 o-Chlorofluorobenzene 350-30-1 3-Chloro-4-Muoronitrobenzene 615-67-8 Chlorohydroquinone 626-39-1 1,3,5-T ribromobenzene 827-94-1 2,6-Dibromo-4-nitromaine Section 4 of TSCA gives EPA the authority to require testing and section 8 gives the reporting authority. For additional information on these sections see page 8 of this Bulletin. SNUR Issued for 11-AA On May 28, 1987, EPA published a significant new use rule (SNUR) for 11-aminoundecanoic acid (11-AA). (52 FR 19860) The Agency believes the substance may be hazardous to health and certain uses of it may result in significant human exposure. A significant new use of 11-AA is any use except when the sub- stance is used: • as an intermediate in the manufacture of polymers in an en- closed process and when 11-AA is expected to be fully poly- merized during the manufacturing process, or • as a component in photoprocessing solutions. The SNUR requires persons who intend to manufacture, import or process 11-AA for a significant new use to notify EPA at least 90 days before beginning that activity. That notice will give EPA time to evaluate the intended use and if necessary prohibit or limit that activity before it begins. EPA is also requiring, under section 8(a) of TSCA, manufac- turers, importers and processors of 11-AA who are not covered by the SNUR to notify the Agency of prospective manufacture, import, or processing. Small businesses that manufacture, im- port, or process 11-AA are exempt from the reporting rule. 5 ------- Section 8(e)... Substantial Risk Below is a list of 16 initial section 8(e) notices recently placed in EPA's public file. For an explanation of section 8(e)and how copies of notices can be acquired see page 8 of this Bulletin. Log No. 8EHQ- Pages* CAS No. 0487-0661 S Poly addition product of bischloromethyl- 63943-38-4 diphenyl and N,N,N',N'- tetramethylhexanediamine 5 Summary results from a dermal sensitization study in guinea pigs 0487--0666 S A diallyl diglycol carbonate 5 Results of a dermal teratology study in rabbits 142-22-1 0487-0668 Xerographic toner 304 Protocol and interim findings from an ongoing chronic study of a Xerox 9000-type photocopying toner by inhalation in rats 0487-0671 Pentachlorophenol and polychlorinated dibenzo-p-dioxins 3 Report of accidental release 0587-0672 S Di (2-ethylhexyl)phthalate 2-Ethylhexanol 2-Ethylhexanoic acid Valproic acid Results of an oral teratology study in rats 20 117-81-7 104-76-7 149-57-5 99-66-1 0587-0673 Bis(trichloromethyl) sulfone and 3064-70-8 Petroleum naphtha solvent (mixture) 56 64742-95-6 Final report from an acute (1-hour) inhalation study in rats 0587-0674 S Sulfurized olefin and substituted ammonium carboxylate (mixture) 110 Results of acute oral, dermal and inhalation studies and a 28- day inhalation study in rats Log No. 8EHQ- Pages* CAS No. 0587-0675 Calcium naphthenate 408 61789-36-4 Final report from a chronic mouse skin-painting study 0587-0676 1,2-Dichloro-1,1-difluoroethane 2 1649-08-71 Preliminary results of a 90-day inhalation study in rats 0687-0677 Pyrazol Yellow BG 250% (C.I. Direct Yellow 28) Preliminary results of an Ames assay 8005-72-9 0587-0678 Pentachlorocyclopropane 8 6262-51-7 Preliminary results of acute oral and dermal toxicity studies in rats 0687-0679 Reaction product of D-glucitol and epichlorohydrin 165 Final reports from six genotoxicologic studies 68412-01-1 0687-0680 Di-, tri-, and tetraiodonaphthalenes (mixture) 168 Final report from a repeated oral gavage study in rats 0787-0681 N-(cyclohexylthio)phthalimide 10 17796-82-6 Final results of a 2-year oncogenicity I chronic feeding study in rats 0687-0682 Dodecylphenol 2 27193-86-8 Preliminary findings from an oral teratology study in rats 0687-0683 Bis(2-dimethylamino ethyl)ether 2 3033-62-3 Preliminary findings of a short-term repeated inhalation study in rats 'S" at the end ot a Log Number means a sanitized versionis available. 1 Page count as ot publication date. New data are constantly being added to section 8(e) tiles. The page total at the time of request may exceed the 125-page cutoff and a charge must be made. For additional information on obtaining section eight(e) files see page 8 ot this issue. EPA Issues Blphenyl Testing Rule On June 3,1987, EPA issued a final Phase I rule for the chemical biphenyl that requires industry to perform specific tests within a scheduled time frame (52 FR 20710). The rule covers environ- mental effects and chemical fate testing. Biphenyl (CAS No. 92-52-4) was designated by the Interagency Testing Committee for priority consideration by EPA [May 25, 1982 (47 FR 22585]. On September 12, 1985, EPA issued, under two-phase rulemaking, a Phase I rule (50 FR 37182), On Decem- ber 12, 1985 a biphenyl industry group submitted to EPA pro- posed study plans and schedules for the required testing. EPA rejected some of the plans and schedules. Revisions were made by the industry group. The June 3, 1987 rule accepts the revised plans and schedules. CORR The Office of Toxic Substances (OTS) is distributing a list of chemical substances, chemical categories and mixtures that are, or have been, subject to proposed or final TSCA regulations and section 313 of the Superfund Amendments and Reauthorization Act. The listing is called Chemicals on Reporting Rules Database (CORR) and is available, as are all other free publications men- tioned in this Bulletin, through the TSCA Assistance Office. In CORR, individual substances are listed by Chemical Abstracts Service (CAS) Registry Number. Categories of chemicals and chemicals without CAS numbers are listed in alphabetical order or by their TSCA premanufacture notice number. Each chemical, mixture or category is followed by one or more rule codes. The codes are explained in an index that includes information on Fed- eral Register citations, the Code of Federal Regulations citations and dates relevant to the rulemaking. CORR will be updated quarterly. The most recent update includes OTS regulations through June 30, 1987. 6 ------- Latest FYI Submissions In recent weeks EPA received 12 FYI (For Your Information) sub- missions. For additional information on FYls see page 8 of this Bulletin. Pages* 284 CAS No. 68-12-2 109-55-7 111-18-2 Log No. FYI OTS-0587-0545 N,N-Dimethylformamide Dimethylaminopropylamine N,N,N,N,-Tetramethyl-1, 6-Hex anediamine Reports on 3 section 8(c) allegations, final results from guinea pig maximization tests, acute oral and inhalation toxicity stu ies, primary dermal irritation tests and an Ames mutagenicity assay OTS-0587-0548 1,1,1-Trichloroethane 71-55-6 Published report reviewing carcinogenicity bioassay results in rats unknown OTS-0687-0549 36 Tungsten Carbide Final results from an epidemiology study entitled "Mortality Among Carbology Workers" OT S-0687-0550 40 Bis(Tri-n-Butyltin) Oxide 56-35-9 Protocol and final report on a lifetime chronic toxicity and car- cinogenicity study, a tentative evaluation for human safety, and summarized results from a series of short-term toxicity studies in rats OTS-0687-0551 61 4-Chloro-2-Methylaniline 95-69-2 Thiourea 62-56-6 Published information on chemical and physical properties, pro- duction, and use Log No. FYI Pages* CAS No. OTS-0687-0553 4 Diethylene Glycol Dimethyl Ether 111-96-6 Summarized results of a two week subchronic inhalation study in rats AX-0687-0554 Catalytically Cracked Clarified Oil Solvent Refined Coal Distillate 39 64741-62-4 unknown Solvent Henneu OUcll L/tOilliuiv Preliminary report on limb bud tissue culture studies AX-0687-0555 345 Light Catalytically Cracked Naphtha 64741-55-5 Draft report on a 13 week subchronic inhalation study in rats OT S-0687-0556 1 Nitrosamines none Nitrosomorpholine 59-87-2 Morpholine 110-91-8 Report on concentration levels found in water glycol hydraulic fluids OTS-0687-0557 60 Vinyl Fluoride 75-02-5 Draft report of results from an in vivo mutagenicity mouse micro- nucleus test AX-0787-0558 4 Benzidine 92-87-5 befa-Naphthylamine 91-59-8 Summarized results from an epidemiology study indicating ex- cess kidney and bladder cancers in workers "Page count as of publication date. New data are constantly toeing added to the FYI tiles. It the page total at the time of a request exceeds ttie 125-page cutoff, a change must be made. For additional information on obtaining FYI tiles see page 8 of this issue. OTS-0687-0552 4,4'-Methylene-bis-2-Chloroaniline Case report of worker bladder tumor 101-14-4 EPA Issues: Hydroqulnone Test Standards, Reporting Requirements On May 28, 1987 EPA published a rule that specifies certain guidelines, protocols and schedules as the test standards and re porting requirements for the testing of hydroquinone (5 19865). This action results from the December 30,1995 issuance of a rule by EPA establishing testing requirement under T manufacturers of hydroquinone (CAS No. 128-31-9)- time the Agency also proposed that certain TSCA test gui e in and industry submitted protocols be used as the test s an ar for the required studies. EPA also proposed that that test date submitted within specified time frames. EPA reviewed comm received on test guidelines and scheduling for hydroqui issued the May 1987 rule. The TSCA Guide for Chemical Importers/Exporters has been up- dated. Volume I of the guide provides an overview of the require- ments under sections 12 and 13 of TSCA. Volume II and the Ad- dendum provide an alphabetical listing of the chemicals relevant to these requirements. The two volume set is available through the TAO. EPA Sets Testing For DCBTF On June 23,1987, EPA signed an enforceable testing consent order with Occidental Chemical Corp. in which the company agreed to perform certain chemical fate and environmental effects tests on 3,4-dichlorobenzotrifluoride (DCBTF) (52 FR 23547). EPA considers this action to be its response to the Interagency Testing Committee's recommendation that the Agency consider health effects, chemical fate and environmental effects testinq of DCBTF [May 28,1984 (49 FR 22389], 7 ------- Substantial Risk... Section 8(e) Under section 8(e), persons who obtain new information that rea- sonably supports the conclusion that a substance or mixture which they manufacture, import, process or distribute presents substantial risk of injury to human health or the environment, must notify EPA within 15 working (jays. 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 work- ing days of obtaining the information. 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, ground floor, Northeast section, 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, D.C. 20460. There is no charge for duplicating the first 124 pages, but at page 125 of a request for duplication there is a $25.00 fee and a 20 cent charge for each additional page (e.g., 126 pages will cost $25.20). Single copies of the section 8(e) status reports (not the full sub- missions) are available from the TAO. Testing of Chemical Substances and Mixtures... Section 4 Section 4 of TSCA gives EPA authority to require manufacturers or processors of chemicals to test the toxic effects of a desig- nated substance. To require testing, EPA must find that the chemical may present an unreasonable risk; that there are insuf- ficient data available with which to perform a reasoned risk as- sessment; and that testing is necessary to generate such data. A test rule may also be based on an EPA finding of substantial pro- duction 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 consid- eration for the promulgation of section 4 test rules. The ITC can designate up to 50 chemicals or categories of chemicals for test- ing and must make revisions to this section 4 priority list as needed. In turn, EPA must respond within one year after the ITC adds a substance to the priority list by starting rulemaking under section 4 or giving reason for not doing so. Section 8(a)... Preliminary Assessment Information Rule Manufacturers (including importers) of chemical substances listed in the section 8(a) rule must report certain production, use, and exposure data to EPA using the rule's Report Form. EPA may add chemicals to the rule when the Agency wishes to obtain Preliminary Assessment Information of those substances. For Your Information (FYI) For Your Information (FYI) submissions are submitted voluntarily to the Agency or to the Office of Toxic Substances (OTS) on chemical toxicity and/or exposure. FYls are submitted by chemi- cal manufacturers, processors and distributors, trade associa- tions, labor organizations, Federal, State or local agencies, for- eign governments, academia, public interest and environmental groups, as well as by the general public. Microfiche copies of these submissions are located in the OTS Public Reading Room, ground floor, Northeast section, Waterside Mall, 401 M Street, S.W., Washington, D.C. To obtain a copy of an FYI, follow the procedure outlined under section 8(e) Substantial Risk just above. Citizens' Petition... Section 21 Under section 21 of TSCA any person may petition the EPA Ad- ministrator to begin a proceeding for the issuance, amendment or repeal of a rule under section 4,6 or 8 of TSCA, or an order undar section 5(e) or 6(b) of the Act. Within 90 days after the petition is filed the Administrator must either grant or deny the petition. The Administrator may hold a public hearing or conduct an investiga- tion or proceeding as deemed appropriate in order to determine whether the petition should be granted. If the petition is denied, the Administrator must publish the reasons for the denial in the Federal Register. If the petition is granted, the Administrator must promptly initiate an appropriate proceeding in accordance with section 4, 5, 6 or 8 of TSCA. TSCA Assistance Office (TS-799) official awiimt Office of Pesticides & Toxic Substances "" "** U.S.E.P.A. tM0 Washington, D.C. 20460. Firat Clan Mall Potlag* and Fmi Paid EPA Parmlt Ho. Q-35 THE TSCA CHEM1CALS-IN-PROGRESS BULLETIN ------- |