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ENVIRONMENTAL PROTECTION AGENCY Informational Notice on the Interagency AGENCY: ENVIRONMENTAL PROTECTION AGENCY NUMBER: OPTS-62045A; FRL-3843-4 CONTACT: David Kling, Acting Director, Environmental Assistance Division (TS- 799), Office of Toxic Substances, Environmental Protection Agency, Rm. E-543, 401 M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0557. For further information on the 33/50 Project, contact Susan B. Hazen, at (202) 382-3671. ACTION: Notice. SUMMARY: This notice is provided to update the activities of the Chlorinated Solvents Project. The Chlorinated Solvents Project was initiated in 1985 by EPA in response to concerns with the use of methylene chloride (DCM, CAS No. 75-09-2), and expanded to include four Federal agencies investigating six major chlorinated solvents in four high-use categories. The integrated regulatory investigation led to significant exposure reductions in the major chlorinated solvent use applications, and established a precedent for future cooperative regulatory endeavors. I. Background In March 1985, the National Toxicology Program (NTP) reported positive results for a cancer bioassay on methylene chloride (DCM). Subsequently, the EPA made a preliminary determination to list DCM as a ''Hazardous Air Pollutant'' under section 112 of the Clean Air Act (CAA), and made a finding under section 4(f) of the Toxic Substances Control Act (TSCA) that occupational and ambient air exposures to DCM may present a significant risk of serious and widespread harm to humans (50 FR 20126, May 14, 1985). On October 17, 1985 (50 FR 42037), EPA issued an Advance Notice of Proposed Rulemaking (ANPR) on DCM. At the same time, EPA initiated an integrated Federal regulatory investigation of DCM in cooperation with the Consumer Product Safety Commission (CPSC), the Occupational Safety and Health Administration (OSHA), and the Food and Drug Administration (FDA). The agencies formed an Interagency Work Group, chaired by EPA's Office of Pesticides and Toxic Substances (OPTS), to determine whether DCM presents a significant risk to human health or the environment, and to determine if regulatory actions are needed to limit exposures to DCM. Following approval by all agencies involved with the integrated regulatory investigation, the Assistant Administrator for OPTS organized an interagency Committee of Office Directors, chaired by the Director of the Office of Toxic Substances (OTS), to oversee the Chlorinated Solvents Project, review the regulatory options developed, and recommend specific courses of action to senior management of participating agencies. Although the Work Group was initially formed to investigate DCM, its focus expanded to include the following solvent chemicals deemed possible substitutes for DCM: trichloroethylene (TCE, CAS No. 79-01-6); perchloroethylene (tetrachloroethylene, PCE, CAS No. 127-18-4); 1,1,1-trichloroethane (methyl chloroform, TCA, CAS No. 71-55-6); carbon tetrachloride (CAS No. 56-23-5); and 1,1,2-trichloro-1,2,2-trifluoroethane (CFC-113, CAS No. 7613-1). The Work Group directed their analyses to the use categories identified as presenting the greatest risk potential for these solvents: dry cleaning, solvent cleaning (electronics and metal cleaning), aerosols, and paint stripping. One of the primary purposes of integrating the chlorinated solvents investigation with other Federal agencies was to identify the most appropriate statutory authority for controlling the risks associated with different solvent uses. Risk control strategies were based on appropriate statutory authorities administered by all four participating agencies. These authorities included the Federal Hazardous Substances Act (FHSA), administered by CPSC; the Occupational Safety and Health Act (OSHAct), administered by OSHA; the Federal Food, Drug, and Cosmetic Act (FFDCA), administered by the FDA; and the Clean Air Act (CAA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Toxic Substances Control Act (TSCA), all administered by the EPA. Regulatory alternatives considered under the FHSA and FFDCA included labeling provisions and product bans. The primary option considered under the OSHAct was lowering of permissible exposure limits (PELs). The other regulatory options considered were National Emission Standards for Hazardous Air Pollutants (NESHAP) under the CAA, pesticide registration controls under the FIFRA, and commercial use bans under the TSCA. When the Work Group began its analysis, there were several existing regulations affecting the use of the chlorinated solvents under investigation. OSHA had existing PEL's for DCM, PCE, and TCE. The existing limits were: 500 ppm for an 8-hour time weighted average (TWA) for DCM; 100 ppm TWA for TCE; and 100 ppm TWA for PCE. Two of the six solvents originally under review by the Work Group were subsequently withdrawn from the analysis. Carbon tetrachloride was no longer being used in the major applications under investigation, and CFC-113 was subject to regulation by EPA's Office of Air and Radiation (OAR), as an ozone depletor (53 FR 30566, August 12, 1988). TCA remained a part of the Work Group analysis, but is now regulated by OAR as an ozone depletor. Under both the terms of the Montreal Protocol on Substances that Deplete the Ozone Layer and Title VI of the new Clean Air Act Amendments, CFC-113 and carbon tetrachloride will be completely phased out by the year 2000, and TCA will be phased out by the year 2002. II. Work Group Activities The Work Group completed hazard assessments for the four solvents remaining under investigation, risk assessments for the four high risk use categories, and economic analyses and risk management options papers for each use category. These references are available as described in Unit IV. A. Summary of Risk Management Actions The Work Group was responsible for conducting risk assessments, and developing risk management strategies for each category. The project did not generally require the Work Group to reconcile conflicting statutory directions, so much as to choose, from among the many authorities, those that would best reduce the risks. Below is a description of risk management actions completed by each agency for the chemicals and uses under review, as well as a discussion of ongoing risk control activities. 1. OSHA. In 1989, OSHA promulgated their generic PEL project, which addressed PEL's of 400 air contaminants. Two of the chlorinated solvents under investigation by the Work Group, PCE and TCE, were included in OSHA's PEL project. The PCE PEL was lowered from 100 ppm to 25 ppm for an 8-hour TWA (January 19, 1989, 54 FR 2686). The standard was revised primarily in response to occupational cancer risks attributable to PCE dry cleaning workplace exposure, although the reduced PCE standard effected reduction in the total occupational cancer risks resulting from PCE solvent cleaning and at aerosol packing plants. For TCE, OSHA lowered the PEL from 100 ppm to 50 ppm for an 8-hour TWA (January 19, 1989, 54 FR 2432). This standard was revised based on occupational cancer risks from TCE solvent cleaning. OSHA is also currently proceeding on a section 6(b) rulemaking for DCM, and is expected to propose a significant reduction of the DCM PEL, presently at 500 ppm, in late 1991. While the PEL would be lowered across the board for all uses of DCM, the reduction would be driven primarily by concern for the risks of solvent cleaning. 2. FDA. On June 29, 1989 (54 FR 27328), FDA promulgated a regulation under the FFDCA prohibiting the use of DCM as an ingredient of cosmetic products. The regulation was primarily targeted at the use of DCM in aerosol hair sprays, which FDA estimated resulted in high cancer risks for hair care specialists and users of hair spray (see 50 FR 51553, December 18, 1985). 3. CPSC. On August 20, 1986 (51 FR 29778), CPSC proposed a rule declaring household products containing DCM to be hazardous substances. CPSC suspended the rulemaking and issued a statement of interpretation and enforcement policy (52 FR 34698, September 14, 1987) declaring several DCM consumer products to be hazardous substances requiring labeling under the FHSA. Required labeling of the DCM products was implemented by CPSC in 1987. CPSC is in the process of assessing the effectiveness of their DCM labeling program. Once the assessment of DCM product labeling effectiveness is completed, CPSC staff will make a recommendation to the Commission on the appropriateness of a ban on certain DCM-containing products. The Commission is scheduled to make a decision on further regulation of DCM in household products in early 1992. 4. EPA. In October 1988, EPA's Office of Pesticide Programs (OPP) conducted a data call-in under section 3(c)(2)(B) of FIFRA. This action required registrants using DCM as an inert ingredient in their pesticide products to either develop toxicity and exposure data on DCM to support continued product registrations, cancel, reformulate their products, or have their registrations suspended. All registrants using DCM as an inert ingredient responded to the data call-in by canceling or reformulating their products, with the exception of one registrant who requested a waiver from data requirements based upon low volume/minor use considerations. On July 25, 1990 (55 FR 30370), the Office of Drinking Water proposed a Maximum Contaminant Level Goal (MCLG) of 0.00 and a Maximum Contaminant Level (MCL) of 5 parts per billion (ppb) for DCM in drinking water. Promulgation of the final drinking water standards for DCM is expected in Spring of 1992. The Office of Air and Radiation began development of a NESHAP for the PCE dry cleaning source category in 1986. On May 19, 1988, a meeting of the National Air Pollution Control Techniques Advisory Committee (NAPCTAC) was held to discuss results of EPA's analysis of control options, and associated environmental, cost, and economic impacts. Shortly thereafter, further work on the PCE dry cleaning NESHAP was delayed to determine the effect of the vinyl chloride NESHAP remand, and possible amendments to the Clean Air Act on subsequent NESHAP development. Currently, OAR plans to propose the PCE dry cleaning NESHAP under section 112 of the new CAA. Under these provisions, EPA will promulgate the PCE dry cleaning NESHAP based on maximum achievable control technology (MACT), which considers technological feasibility and cost. Based on the current schedule, it is anticipated that a NESHAP will be proposed in November of 1991 with promulgation in November of 1992. NESHAP's for DCM, PCE, and TCE solvent cleaning emissions are scheduled to be proposed by 1993. EPA's OTS is examining risk reduction possibilities for dry cleaning consumers. The dry cleaning and PCE manufacturing industries agreed to conduct a study intended to determine ways of minimizing the potential in-house exposures of consumers to PCE that may off-gas from dry-cleaned fabrics. The industry's study commenced in September 1990. The results of the industry's investigation could be used to issue guidance to dry cleaners on opportunities for minimizing any potential PCE contribution from dry cleaning to residential indoor air pollution. B. Other Activities As an adjunct to CPSC's continuing efforts concerning the use of DCM in paint strippers, EPA, in coordination with CPSC, NIOSH, and OSHA, sponsored an International Conference on Reducing Risk in Paint Stripping. The conference was held February 12-13, 1991, in Washington, DC. It was intended as a mechanism for obtaining information on feasible substitutes for DCM paint strippers. The conference brought together several interested Federal regulatory agencies, and both suppliers and users for each sector of the industry: original equipment manufacture (OEM), maintenance, and commercial/consumer refinishing. The discussions at the conference focused on the cost and effectiveness of alternative stripping technologies and information needs, including consideration of waste generation and exposure. III. New Initiatives Although there has been significant risk reduction effected by the agencies participating on the Chlorinated Solvents Project, and many of the most significant risks have been addressed, EPA strongly believes that the use of toxic chemicals, such as chlorinated solvents, should continue to be reduced or controlled wherever possible. While the regulatory actions detailed above yielded significant reductions in the risks associated with these solvents, there remain uses and emissions which result in unnecessary exposures to these chemicals. In a number of cases, the Agency has seen voluntary reductions in the use of these solvents, voluntary substitution of safer alternatives, and the institution of process controls which reduce exposures. In many instances these changes have proven to be both environmentally and economically beneficial. Building on the experience these voluntary actions have provided, the Agency is initiating a project to work closely with facilities in the industrial sector to voluntarily reduce or control unnecessary exposures associated with certain high production/high emission chemicals. These chemicals, which are a subset of the Toxic Release Inventory (TRI) list, have been targeted by the Agency for reductions of 50 percent by 1995, with an interim goal of 33 percent reduction by 1992. Carbon tetrachloride, DCM, PCE, TCA, and TCE are among the 17 chemicals selected for this effort. This project, known as the 33/50 Project, will work with the industrial sector to achieve exposure reductions in all environmental media, as well as transfers of chemical wastes to off-site management facilities. EPA anticipates that most of these reductions can be accomplished through pollution prevention practices which eliminate the wastes at the source, rather than relying on destructive treatment after wastes have been generated. The successes achieved in the integrated solvents regulatory investigation not only addressed risks posed by chlorinated solvents, but also raised the importance of integrated risk management decision making, while laying the foundation for future regulatory integration. With new emphases on pollution prevention and cross-media approaches to environmental risk reduction, such coordinative capabilities are essential. EPA's 33/50 Project is a good example of the type of project that will require such an integrated, cooperative effort for success. IV. Official Record EPA has established an official administrative record in support of this notice docket number OPTS-62045A . This record contains basic information developed and utilized by the Interagency Work Group and Committee of Office Directors over the course of the Chlorinated Solvents Project. The record is available in the TSCA Public Docket Office from 8 a.m. to noon and 1 p.m. to 4 p.m., Monday through Friday, excluding legal holidays. The TSCA Public Docket Office is located at EPA Headquarters, rm. NE-G004, 401 M St., SW., Washington, DC 20460. Dated: May 24, 1991. Victor J. Kimm, Acting Assistant Administrator for Pesticides and Toxic Substances. INTERNAL DATA: FR Doc. 91-12892; Filed 5-30-91; 8:45 am; BILLING CODE 6560-50-F |
