xvEPA OFFICE OF POLLUTION PREVENTION AND TOXICS EPA-745-N-93-001 Chemicals in Progress highlights 2 TRI Releases Decreased by 334 Million Pounds in 1991 3 EPA Plans to Expand the TRI 22 OPPT Proposes New Strategy for Information Management 24 OPPT Assessing Health and Environmental Effects of Cleaning Products Used in Government Buildings OPPT's Pollution Prevention Strategy For Toxic Chemicals By Mark A. Greenwood Director, Office of Pollution Prevention and Toxics The Office of Pollution Prevention and Toxics (OPPT) prepared this paper as a working draft for a discussion organized under the auspices of the American Chemical Society. The paper lays out new directions that OPPT is developing to carry out its responsibility for preventing pollu- tion and reducing risks associated with the manufacture and use of exist- ing chemicals. The paper does not present a comprehensive plan for all OPPT work. The office's responsibilities in areas outside of existing chemicals, such as for new chemicals and for the promotion of other pol- lution prevention strategies (such as environmental cost accounting) are not included. The paper is in draft form and is presented to help initiate a broad-based discussion with interested parties. OPPT hopes to learn from these dis- cussions how to develop the ideas discussed below and to identify con- structive follow-up actions. I. Change to a mission-based definition of the OPPT program The past several years have been a time of important change for OPPT. Much of this change has been a result of OPPT's new responsibilities as national program manager for pollution prevention in EPA. The focus on pollution prevention is the result of lessons learned from years of experi- ence in carrying out the agency's statutory mandates. The changes in OPPT also reflect new attitudes and strategies for environmental protec- tion being embraced by industry, public interest groups, states, and other elements of the public. The tools of public policy must change to reflect the changing expectations and capabilities of these customers. The creation of a comprehensive pollution prevention program is the goal OPPT continued on page 13 B VOL. 14 / NO. 3 NOVEMBER 1993 ------- I Toxics Release Inventory TRI Releases Decreased by 334 Million Pounds in 1991 U.S. manufacturers managed or released 38 billion pounds of toxic chemicals during 1991, according to data submitted to EPA's Toxics Release Inventory (TRI). Of that amount, more than 20 billion pounds were recycled and about 13 billion pounds were treated or con- verted into energy. About 3-36 billion pounds of toxic chemicals were released to the environmentalmost 10 percent less than the quantity released in 1990. This decline in chemical releases continues a trend: TRI data show that emissions to air, water, and land have dropped 30 percent from 1988 to 1991- About 1.07 billion pounds of wastes were transferred off-site for treatment or disposal in 1991, a decrease of 1.2 billion pounds from 1990, New TRI information The TRI, which is available to the public, includes detailed data on the releases and transfers of toxic chemicals from manufacturing facilities across the nation. The 1991 reporting year was the first for which EPA collected information on how industry manages its wastes. Thus, the 1991 TRI pro- vides a more complete picture of waste generation and management than did previous inventories. The TRI is required by section 313 of the 1986 Emergency Planning and Right-to-Know Act (EPCRA). The information on waste manage- ment is required by the Pollution Prevention Act of 1990. Required information includes recycling, energy recovery, and source-reduc- tion activities. Since 1987, about 24,000 indus- trial facilities have reported annu- ally on more than 300 chemicals, including 20 chemical classes. EPA received 81,545 reports for the 1991 reporting year. TRI data show that emissions to air, water, and land have dropped 30 percent from 1988 to 1991. Summary of 1991 TRt data Releases to air. 1991 TRI data show that 1.98 billion pounds of toxic chemicals were released to the air, a decrease of more than 13 percent from the 1990 total of 2.28 billion pounds. EPA attributes this decrease to reduced emissions of industrial solvents. Releases to water. 1991 TRI data show that about 244 million pounds of toxic chemicals were released to the nation's rivers, streams, and other bodies of water, an increase of almost 24 percent from the 1990 total of 197 million pounds. EPA attributes this increase to runoff from an incident involving four fertilizer facilities in Louisiana. Without this runoff, water releases would have declined 7 percent, according to EPA. Releases to land. 1991 TRI data show thac about 421 million pounds of toxic chemicals were released to land, a decrease of 9 percent from the 1990 total of 463 million pounds. Underground injection. 1991 TRI data show that about 710 million pounds of toxic chemicals were injected underground, a decrease of 5 percent from the 1990 total of 745 million pounds. For more information To obtain the 1991 Toxics Release Inventory: Public Data Release, EPA 745-R-93-003, contact the EPCRA Hotline at (800) 535-0202 or (703)412-9877. For information on obtaining access to the TRI database in the National Library of Medi- cine's TOXNET system, call the library's TRI representative at (301)496-6531. For information about other ways to gain access to the TRI, contact the EPCRA Hotline at the number listed above. 0 CHEMICALS IN PROGRESS ------- Toxics Release Inventory EPA To Collect More TRI Data in the Future EPA plans a significant expansion of the Toxics Release Inventory (TRI). Early next year, the agency expects to propose a rule that would add more than 300 chemi- cals to the TRI reporting list. By next fall, the agency plans a sec- ond proposed rule that would require additional types of facili- ties to report. The additional data will provide a more complete picture of chemical releases in our nation's communi- ties. It will also be useful for iden- tifying further opportunities for pollution prevention. Why expand TRI? The TRI was the first program that made information about chemical releases and transfers readily available to the public. Since the first year of reporting in 1987, the usefulness of TRI data has become increasingly evident. The public, the government, and the regulated community use TRI data to compare the levels of releases and chemical wastes among states, industries, facilities, and environmental media. The Emergency Planning and Community Right-to-Know Act (EPCRA), which established the TRI, also defined the manufactur- ing facilities that are required to report and the chemicals for which reporting is required. About 300 toxic chemicals and chemical com- pounds are listed in section 313 of EPCRA. The facilities required to report are those manufacturers that have 10 or more full-time employ- ees and that are in the U.S. Com- merce Department's Standard Industrial Classification (SIC) codes 20 to 39- Federal facilities were not included. EPCRA gives EPA the authority to modify both the list of chemi- cals and the type of facilities required to report. Thousands of chemicals in commerce, in fact, may meet the criteria of the law for TRI reporting. Furthermore, many sectors of the economy process, use, and even manufacture many toxic chemicals that are cur- rently reportable. It is as appropri- ate for the public to know about these releases as it is for them to know about releases from manufac- turing facilities. For 1991, the most recent year for which EPA collected data, 83,000 TRI reports were submitted by about 23,000 facilities. Despite the large amount of data collected, envi- ronmental groups have for many years asked EPA and Congress to add more chemicals to the report- ing list. Last year, a legislative effort by Senator Frank Lautenberg (D-NJ) and former Representative Gerry Sikorski (D-MN) to add almost 600 chemicals to the TRI failed. At the same time, EPA began exploring how to expand the TRI. Two-phased approach EPA plans to expand the TRI in two phases. In May 1993, EPA Administrator Carol Browner announced EPA would propose a TRI Data continued on page 4 Chemicals Under Consideration Clean Air Act, section 112(b), as amended in 1990: Hazardous Air Pollutants Clean Air Act, section 602(b): Class II ozone-depleting substances Clean Water Act, section 307(a): Priority pollutant list Federal Insecticide, Fungicide, Rodenticide Act (FIFRA), sec- tion 6: Special review, canceled/ denied or suspended, and restricted use pesticides Resource Conservation and Recovery Act, section 3001 and chemicals listed at 40 CFR 26l.33(f) and in appendix VIII EPCRA, section 302: Extremely hazardous substances Comprehensive Environmental Response, Compensation, and Liability Act, section 102 Safe Drinking Water Act, sec- tion 1412, as amended The State of California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): List of chemi- cals known to the state to cause reproductive toxicity In addition, EPA considered chem- icals designated as possible, proba- ble, or known carcinogens in the Monographs of the International Agency for Research on Cancer and in the 6th Annual Report on Carcinogens of the National Toxicology Program, published by the U.S. Department of Health and Human Services. VOL. 14/NO.3 NOVEMBER 1993 ------- I Toxics Release Inventory TRI Data continued from page 3 rule to add at least 170 chemicals to the TRI list. Browner said that EPA will announce a candidate list of additional facilities by next spring or by the time of the next TRI data release. This is not the first time that EPA has modified TRI reporting requirements. In 1989, for exam- ple, EPA added nine chemicals to the TRI list (54 FR 49948, Decem- ber 1, 1989). In addition, EPA has made a number of changes to the TRI list in response to petitions submitted to EPA under section 313(e). As of August 1993, in response to these petitions, EPA has deleted 12 chemicals from the TRI list and added 16. Phase 1: Process for adding chemicals to the TRI list. As a starting point, EPA is examining the more than 1,000 chemicals regulated under various statutes. To screen such a large number of chemicals, EPA developed a methodology and some criteria for prioritizing chemicals for further evaluation. According to EPA's schedule, the newly desig- nated TRI chemicals would be reportable for the first time on TRI reports due July 1, 1994. The statutes that contain the chemicals that EPA is considering for addition to the TRI list are shown in the list on page 3. Phase 2: Process for adding facilities to the TRI list. EPA is considering requiring facilities that perform manufacturing-like activities to report to the TRI. These facilities mix, formulate, or distribute mate- rials that contain TRI chemicals. EPA is also examining treatment and disposal facilities, which are not required to report even though many receive wastes containing TRI chemicals. Newly listed facil- ities would have to provide TRI reports by July 1, 1995. Many federal facilities are also sig- nificant customers of the chemical industry. The process for obtaining TRI information from these facili- ties has already begun. In August 1993, President Clinton directed federal facilities to submit TRI reports beginning with calendar year 1994. (See article on page 5.) For more information Call Maria Doa, of OPPT's Envi- ronmental Assistance Division, at (202) 260-9592, or Tim Crawford, of OPPT's Environmental Assis- tance Division, at (202) 260-1715. Or, write to them at the address on page 43. Update on TRI Section 313 Petitions Anyone can petition EPA to add or delete a chemical from the list of toxic chemicals that are subject to Toxics Release Inventory (TRI) Receipt Date Chemical Name reporting. The list on this page shows petition activity occurring from January 1993 through August 1993. For more information, call Maria Doa at (202) 260-9592 or the EPCRA Hotline at (800) 535-0202 or (709) 412-9877. Submitter Action 180-Day Proposed Rule Final Rule or Requested Deadline FR Pub Date Denial Pub Date Petitions Pending 10/6/92 Cr, Mi, Cu, in Brass, Bronze and Stainless Steel 03/05/93 Cl Pigment Blue 15:1 Proposed Rules 09/24/91 11/06/91 01/28/92 Barium Sulfate Barium Sulfate Di-N-Octyl Phthalate Stillwater Fasteners Exempt 04/06/93 / / / / Color Pigments Manufacturers Assn. Delist 09/08/93 / / / / Chemical Products Corp. Delist / / 06/11/93 / / Dry Color Manufacturers Assn. Delist / / 06/11/93 / / Vista Chemical Company Delist / / 01/13/93 / / CHEMICALS IN PROGRESS ------- Toxics Release Inventory Clinton Tells Federal Agencies to Reduce Pollution, Report to TRI On August 3, 1993, President Clinton signed an executive order that requires federal facilities to comply with planning and report- ing provisions of the Emergency Planning and Community Right- To-Know Act and the Pollution Prevention Act of 1990. The exec- utive order goes beyond these laws' requirements, though, asking fed- eral facilities to lead the nation in preventing pollution and adhering to right-to-know principles. Here is a summary of the executive order's major requirements: Federal agencies are required to submit Toxics Release Inventory (TRI) reports beginning with the 1994 calendar year. The sub- mission deadline for the 1994 calendar year is July 1, 1995. Federal agencies are required to establish voluntary goals to reduce all TRI chemical releases and transfers for treatment and disposal. The goal for reductions is 50 per cent by 1999. Some agencies are expected to broaden their voluntary goals and reduce other pollutants as well. Federal agencies are required to develop and make public their plans for reducing or eliminating the manufacture, processing, and use of toxic chemicals and extremely hazardous substances. As part of this effort, agencies are to review and modify procure- ment and acquisition practices and generally employ source reduction as a first method of choice to reach their goals. EPA will be responsible for moni- toring compliance for this executive order and will also set up an incen- tives program. The Federal Govern- ment Environmental Challenge Program will recognize outstanding environmental management by fed- eral agencies and their employees. California Asks U.S. Facilities to File TRI Reports U.S. military bases and Depart- ment of Energy facilities located in California were asked by the state to report their releases of toxic chemicals to the California Depart- ment for Environmental Protec- tion. Federal facilities are exempt from the federal law that requires industrial facilities to report releas- es of toxic chemicals to the U.S. EPA. EPA compiles the data in the Toxics Release Inventory (TRI). Many states also require TRI reporting and maintain their own TRI databases. "This action puts the government on the same footing as private companies," said Jim Strock, Sec- retary of the Department for Environmental Protection. On March 1, Secretary Strock asked 42 military bases and six U.S. Energy Department facilities to file TRI forms no later than July 1, 1993. State TRI coordinator Steve Hanna said that two military bases have agreed to submit TRI reports by the deadline, two bases plan to submit reports by July 1, 1994, one base is preparing guidance for submitting data, and 13 bases refused to report. One base said it is closing and another said it does not process or use any TRI sub- stances in the threshold amounts required for reporting. Other responses are expected in the future. B Two Department of Energy facili- ties agreed to report, Mr. Hanna said. One facility said it is below the reporting threshold, one stated it would not report, and two did not respond. About the same time, the Department of Energy announced it would file TRI forms for all of its facilities starting on July 1, 1994. The state request parallels similar activities occurring at the federal level. In August 1993, President Clinton issued an executive order requiring all federal facilities to file TRI reports by July 1, 1995. (See article on this page.) VOL. 14/NO.3 NOVEMBER 1993 ------- I Existing Chemicals Program TSCA Chemical Testing Program: Implementing a Program for the '90s By Joseph S. Carra Deputy Director, Office of Pollution Prevention and Toxics The Chemical Testing Program was established in EPA's Office of Pollution Prevention and Toxics (OPPT) to carry out the policy expressed in section 2 of the Toxic Substances Control Act (TSCA) that adequate data be developed with respect to the health and environmental effects of chemical substances and that the develop- ment of these data is the responsi- bility of chemical manufacturers and processors. In recent years, OPPT has received criticism (e.g., from the Government Accounting Office, Congress, environmental groups) for a general "lack of pro- ductivity" in its TSCA Chemical Testing Program. While criticism of past productivity is deserved, OPPT's TSCA Chemical Testing Program has made substantial progress and the prognosis for the future is positive. The early years Since the enactment of TSCA in 1977, OPPT and the Interagency Testing Committee (ITC) have reviewed a large number of the 70,000 chemicals listed on the TSCA Chemical Substances Inven- tory to determine the need for health and/or environmental test- ing. (The ITC is a federal intera- gency body established by TSCA that makes recommendations to EPA about testing.) For example, the ITC, in fulfilling its mandate under section 4 of TSCA, has reviewed in excess of 50,000 chemicals to determine if testing is needed to characterize potential health and/or environmental risks. As a direct result of years of chem- ical screening efforts, OPPT has determined that its efforts to iden- tify candidates for testing or risk assessment should focus primarily on the approximately 14,000 non- polymeric TSCA Inventory chemi- cals that are produced at levels of over 10,000 pounds per year. OPPT has employed and will con- tinue to employ reactive and proactive hazard-based and expo- sure-based screening techniques to identify priority testing candi- dates from among this 14,000 chemical subset. Since 1977, OPPT has published over 30 TSCA section 4 final test rules covering more than 60 chem- icals and is currently in the process of promulgating final Test Rules on more than 30 additional chemicals. OPPT expects to receive completed test data sets on approximately 60 chemicals by October 1993. Once received, the total number of chemical substances that will have completed health and/or environ- mental testing under the TSCA Chemical Testing Program since 1977 will be about 160. Meeting the future In order to increase productivity, OPPT is now seeking testing through mechanisms other than the time-consuming "notice and comment" rulemaking procedures of section 4 of TSCA. Recently, OPPT has instituted two strategic changes in the TSCA testing pro- gram that should accelerate testing actions. First, OPPT has redefined its test- ing program to include the devel- opment of testing actions by means other than TSCA section 4 test rules, namely negotiated enforceable consent agreements (EGAs) under TSCA, and volun- tary testing programs. ECAs are used in those situations in which chemical manufacturers or groups of manufacturers agree to conduct testing under the potential sanc- tions of TSCA. The EGA mecha- nism was established in accordance with the procedures specified in the U.S. Code of Federal Regula- tions. In July of 1992, OPPT announced an open season to encourage chemical manufacturers and processors to submit offers to conduct ECA-based testing on chemicals for which OPPT had not yet issued final testing actions. OPPT received and evaluated 22 testing offers covering 12 individ- ual chemicals and four chemical categories. In March 1993, OPPT B CHEMICALS IN PROGRESS ------- I Existing Chemicals Program solicited interested parties and negotiations are now under way on submitted offers; negotiations are continuing. The second strategic change OPPT made to its Chemical Testing Pro- gram involves the development of a Master Testing List (MTL). The MTL establishes for OPPT a clear agenda of priority testing needs identified by EPA, other federal agencies, and the international community as represented by the Organization for Economic Coop- eration and Development (OECD). The MTL also allows OPPT to focus its limited resources on the highest priority testing needs. In addition, OPPT uses the MTL to keep the public informed of OPPT's testing priorities and to solicit public input into OPPT's Chemical Testing Program. Final- ly, OPPT uses the MTL to encour- age chemical industry initiatives to conduct testing designed to address and fill the priority data needs identified on the MTL. With regard to voluntary testing initiatives, one program in partic- ular is of major importance to EPAthe OECD Screening Infor- mation Data Set (SIDS) program. Under the auspices of the OECD, of which the United States is a member along with 23 other coun- tries, member countries "share the burden" of chemical testing. The OECD/SIDS program is focused on obtaining needed test data for international high-production-vol- ume chemicals and allocates chem- icals among the OECD countries for testing using a formula based on each nation's gross national product. The United States is responsible at the present time for conducting the testing on 25 per- cent of the SIDS chemicals while the other OECD member countries cover the balance. Prior to the SIDS program, the United States was conducting more than 90 per- cent of the world's chemical test- ing; the OECD/SIDS program offers the opportunity for sharing the testing burden and dramatical- ly increasing the amount of world- wide testing of those chemicals posing the greatest potential for harm to health and/or the environ- ment. Since the OECD/SIDS pro- gram began several years ago, test- 'ing has been completed on 30 chemicals and testing will be initi- ated on an additional 120 chemi- cals by the end of 1993; testing on another 30 to 50 chemicals will be initiated in 1994. The fact that most of the OECD/SIDS chemicals are in U.S. commerce makes this voluntary international testing program a very important compo- nent of EPA's domestic chemical testing program. By establishing a TSCA Chemical Testing Program that utilizes a variety of available tools, the development of test data is acceler- ated and a greater number of chemicals can be tested. EGAs and voluntary testing agreements clearly offer OPPT and the regu- lated community less resource intensive and less time-consuming alternatives for obtaining test data. Another major benefit of using EGAs and voluntary testing agree- ments is that these mechanisms provide opportunities for industry to offer balanced programs addressing OPPT's concerns about a chemical by combining testing activities with pollution preven- tion and product stewardship efforts designed to reduce or elimi- nate chemical exposures leading to reduced potential health and/or environmental risks. Into the future It is clear that OPPT's TSCA Chemical Testing Program is viable and is becoming more pro- ductive. As OPPT moves forward under the new administration, the strategies outlined above are expected to significantly increase the pace and scope of OPPT's chemical testing actions. Using a mix of regulatory, voluntary and consent agreement actions, OPPT now has active projects to obtain testing on almost all of the more than 300 chemicals currently list- ed on the MTL. OPPT intends to ensure that its Chemical Testing Program represents the best efforts of EPA to meet the data needs of the agency and others and at the same time achieve success in these efforts by using the most effective balance of TSCA regulatory and non-regulatory tools available. B VOL. 14/NO.3 NOVEMBER 1993 ------- I Existing Chemicals Program Update of Existing Chemicals Program RM1 and RM2 Activity EPA's Existing Chemicals Program screens those chemicals currently in production or in use to deter- mine their potential health and environmental risks. If potential risks are identified, a further assessment is performed and risk reduction strategies are developed. These activities occur in two dis- tinct stages. In the first stage, Risk Manage- ment One (RM1), chemicals are screened to identify those that (1) require additional testing, (2) present potentially signifi- cant risk-management concerns, or (3) do not currently require further review. In the second stage, Risk Man- agement Two (RM2), chemicals that present significant risk- management concern are further assessed. Strategies to reduce or eliminate the potential risks posed by exposure to these chemicals are developed. For more information The Office of Pollution Prevention and Toxics (OPPT), which admin- isters the Existing Chemicals Pro- gram, encourages public participa- tion throughout the RM process. RM materials are available from the RM administrative record, located in the TSCA Non-Confi- dential Information Center. For information about the center, call (202) 260-7099 or (202)260-0660. RM Risk Management (RM) Activity from January 1,1993, through September 15,1993 Chemical Name Source/ Why is it in RM? Acrylamide/ In 1991, EPA pro- N-rnethylacrylamide : posed a rule to (1) (NMA) Acrylonitrile immediately ban acrylamide from all grouting uses; (2) Concerns Cancer concerns for workers exposed to acrylamide and NMA during grouting. immediately ban , NMA from all grout- ing uses except sew- er applications; and (3) ban the sewer applications use in three years. High-production vol- ume chemical with large environmental releases as reported to the Toxics Release Inventory. Acrylonitrile is classi- fied by EPA as a B1 "probable human carcinogen." Stage in Process Evaluating comments to 1991 proposed rule. Next Steps Developing response and preparing final rule. Projected Resolution Anticipate issuing a final rule in early 1994. i OPPT has concluded that the chemical industry has taken EPA's concerns for acrylonitrile very seriously. No further OPPT action is war- ranted at this time, although EPA will provide technical support to other EPA offices evaluating the risks posed by acry- OPPT is writing let- ters to acrylonitrile manufacturers encouraging them to continue their pollution prevention efforts. Project closure anticipated by fall 1993. lonitrile. D CHEMICALS IN PROGRESS ------- I Existing Chemicals Program RM Risk Management (RM) Activity from January 1,1993, through September 15,1993, cont'd Chemical Name Aerosol Spray Paints Benzidine Dyes Chlorinated Paraffins (CPs) Chloroethane Cultural Uses of Mercury Source/ Why is it in RM? To investigate pollu- tion prevention opportunities. Benzidine is a known human carcinogen and benzidine con- geners are animal carcinogens. Designated for test- ing by the Inter- agency Testing Committee for both human health and environmental concerns. High production vol- ume chemical with significant releases to air and water as reported to the Toxcs Release Inventory. Referral from state of California that certain ethnic groups were using mercury in some of their reli- gious practices. Concerns Some chemicals Stage in Process Developing project found in aerosol : scope. spray paint are carcinogenic. Con- cern for consumers Next Steps Perform substitute analyses and new technologies assess- ments, hold informa- tional exchange and workers who ; meetings with use aerosol spray paints in indoor air industry. environments. Cancer concerns 1or workers exposed to these chemicals. Short-chain CPs and alpha olefins used in metai-working fluids are hazardous to aquatic lite. All CP chain lengths are of concern to human health. Chloroethane is an Preparing for negoti- ations with industry, labor unions, and environmental groups. Preparing for risk management deci- sion making. OPPT negotiated a animal carcinogen labeling program with based on a 1989 Chloroethane manu- National Toxicology facturers to warn Program study. workers who install : chloroethane-con- Neurotoxicity and potential lethality to individuals who use mercury in these practices. I taining foam boards of the hazards and to provide recommen- dations on how to reduce exposure. Developing outreach and education cam- paign targeting affect- ed communities. Hold negotiation meetings. Select risk manage- ment strategy. Develop radio public service announce- ments and distribute fact sheets to com- munity organizations. Projected Resolution Complete RM2 by the middle of 1994. Hoping to complete a SNUR for benzidine- based dyes and an MOU in principle by December, 1993, for non-metalized diani- sidine-based dyes. Expect to complete RM2 by September 1993. Project completed. Anticipate completion of program by November 1993. Q VOL. 14/NO.3 NOVEMBER 1993 ------- I Existing Chemicals Program RM Risk Management (RM) Activity from January 1,1993, through September 15,1993, cont'd Chemical Name 1,2-Dichloroethane Glycol Ethers Update and Follow-on Mercury N-Methylpyrrolidone (NMP) 2-Nitropropane (2-NP) Nitrosamines Source/ Why is it in RM? High-volume feed- stock chemical that is an EPA B2: "probable human carcinogen." TSCA8(e)data reporting preliminary results that expo- I sures to these chemi- cals could be linked to an increased inci- dence of sponta- neous miscarriages in women working in semiconductor man- ufacturing plants. Evaluation of envi- ronmental exposures from the disposal of consumer products containing mercury. Referral from the Consumer Product Safety Commission. Animal carcinogen with possible high exposures to workers. i Request from the United Rubber Work- ers Union to evaluate the potential risks posed by these chemicals. Concerns Cancer risk to indi- viduals living near 4 specific facilities. Reproductive toxicity to workers. i Mercury is a highly toxic chemical, caus- ing serious neurolog- ical effects at very low exposure levels. Reproductive toxicity to workers and to users of consumer "do-it-yourself" paint stripping products. Cancer and liver toxi- city concerns for workers. Cancer concerns for workers in the rubber manufacture and leather tanning industries. Stage in Process Finalizing draft | report. ] i Evaluating data results. i Under most circum- stances, human exposure to mercury is negligible. Discussing risk man- agement strategies with industry groups, labor unions, and consumer groups. Completed RM2 evaluation. Stakeholder's dia- logue held in July 1993. Currently i incorporating new information into review. Next Steps Distribute final report to interested parties. Complete data reviews; review/revise hazard and risk assessments; identify potential substitutes. OPPT may provide technical support to EPA's Office of Solid Waste. Negotiate a glove testing and product warning program. Informal referral to the Occupational Safety and Health Administration. 2-NP may be added to OPPT's Master Testing List. Further review, and discussion of risk reduction methods ; with stakeholders. Projected Resolution Anticipate completion of project by December 1993. Project closed in August 1993. Work on this project will be incorporated into OPPT's activities on a consumer/small shop paint stripping use cluster analysis. Project closed in September 1993. n CHEMICALS IN PROGRESS ------- I Existing Chemicals Program RM Risk Management (RM) Activity from January 1,1993, through September 15,1993, cont'd Chemical Name Non-Residential Lead Paints Land-Applied Sludge Source/ Concerns Why is it in RM? In 1991 EPA pro- posed a rule to gov- ern the land applica- tion of pulp and paper mill sludge contaminated with dioxins and furans. Concerns for occupa- tional exposures and general population exposures. Dioxins and furans are very toxic to humans. Stage in Process Held stakeholder dialogues to discuss substitutes and possible abatement technologies. Negotiating a volun- tary agreement which will set up guidelines for land application dioxin/fu ran stan- dards and manage- ment practices and to obtain data to improve our under- standing of the eco- logical risks of sludge land application. Next Steps ! Projected Resolution Finalizing EPA evaluation. Develop the actual agreement with industry. Completion of project is likely in fall 1993. Voluntary agreement expected to be signed by January, 1994. PCB Rules Revised to Update RCRA References EPA has updated references to reg- ulations that govern the marketing and burning of used oil containing polychlorinated biphenyls (PCBs) at levels of less than 50 parts per million (ppm). The technical amendment became effective on March 23, 1993 (58 FR 15435). Under the Toxic Substances Con- trol Act (TSCA), EPA allowed waste oil with fewer than 50 ppm PCBs to be burned and marketed for purposes of energy recovery. In the TSCA PCB regulations, the agency referenced Resource Con- servation and Recovery Act (RCRA) requirements. However, the RCRA requirements were repositioned on September 10, 1992, when EPA published a final rule that established standards for used oil. Specifically, the provisions at 40 CFR Part 266 were moved to the newly created 40 CFR Part 279 (57 FR 41566). To reflect this change, EPA amended TSCA PCB regulations at 40 CFR 76l.20(e). The amendment does not change the substantive requirements of the TSCA PCB regulations and does not affect the burden on the regu- lated community to comply with TSCA used oil requirements. In addition, EPA published a cor- rection to the March 23 technical amendment (58 FR 32060). The correction addressed the omission of a citation found in paragraph (4) of the definition for a "qualified incinerator" at section 761.3- The reference to industrial furnaces and boilers in 40 CFR 266.4 l(b) should have been changed also to read 40 CFR 279.6l(aXD and (2). B VOL. 14 / NO. 3 NOVEMBER 1993 ------- Existing Chemicals Program Efforts to Replicate Anderson Laboratory Carpet Study Point to More Work Ahead "Failure to replicate the findings does not prove that carpet emissions do not pose any adverse effects...." EPA has been unable to indepen- dently reproduce the findings of a 1992 private study in which mice died after being exposed to carpet emissions. Failure to replicate the findings does not prove that carpet emissions do not pose any adverse effects, said Victor J. Kimm, acting administrator for EPA's Office of Pollution Prevention and Toxic Substances, in testimony before the House of Representatives' Subcom- mittee on Environment, Energy, and Natural Resources in June 1993. At the same time, he said, EPA does not have a sound basis for concluding that exposure to carpet emissions presents a health risk. Background In a 1992 announcement, Ander- son Laboratories, of Dedham, Mass- achusetts, described neurotoxicity, pulmonary irritation, and death in mice exposed to emissions from certain carpets. The lab's findings seemed to support complaints asso- ciating health problems with expo- sure to emissions from carpets. In January 1993, EPA scientists traveled to Anderson Laboratories, where, using a combination of EPA and Anderson apparatuses, they conducted a carpet emissions test in which some mice died. However, a scientific finding is considered reliable only when it can be independently replicated. In a replication study in EPA labs, EPA scientists were unable to pro- duce severe toxicity in mice, nor m did EPA's tests produce any con- vincing signs of even mild toxicity. Details of study replication The replication study was conduct- ed simultaneously by EPA and Anderson Laboratories. EPA collab- orated with Anderson Laboratories in designing and executing the study. Both EPA and Anderson Laboratories agreed to the protocol for performing the study. Each lab received pieces from the same car- pet to test, and scoring procedures for neurotoxicity were developed by EPA and Anderson Laboratories. EPA found no deaths in 24 tested animals, no severe or moderate sensory irritation, and no clear evi- dence of neurotoxicity. By con- trast, Anderson Laboratories found five test-related deaths, pulmonary irritation, and neurotoxicity in 24 tested animals. Both labs sent draft reports of their findings to a panel of independent scientists for peer review. At the conclusion of the peer review, it was clear that there was virtually nothing in common between the two sets of findings. EPA con- cludes that an essential difference between the conditions of its experiments and those of Anderson Laboratories exists but has not been identified. EPA addresses indoor air quality At this point, EPA is continuing research to determine the cause of Anderson Laboratories' findings. Carpet continued on page 13 CHEMICALS IN PROGRESS ------- I Existing Chemicals Program Carpet continued from page 12 EPA is addressing carpet-related issues as part of its indoor air qual- ity strategy. Descriptions of some EPA activities follow. EPA has scheduled a workshop at which scientists working on carpet emissions will present data on their experience with Anderson Laboratories' test pro- cedure. Scientists from the car- pet industry, Anderson Labora- tories, and EPA, in addition to independent peer reviewers, will participate in the workshop. EPA will consider the outcome of the workshop in deciding what steps are necessary to fur- ther understanding of concerns about carpets. EPA is continuing efforts to develop better methodologies for detecting and studying the potential health effects of emis- sions from indoor sources. For instance, toxicology tests to detect health effects associated with indoor air complaints are being developed by EPA's Office of Research and Develop- ment's Health Effects Research Laboratory. EPA is continuing to follow the voluntary testing of emissions from carpet and carpet products. The testing is being performed by the Carpet and Rug Insti- tute, the Carpet Cushion Coun- cil, and the Floor Covering Adhesive Manufacturers Com- mittee. The voluntary testing programs were one of the many agreements that came out of a carpet policy dialogue, convened by EPA in 1990 as part of its general pollution prevention strategy to minimize indoor exposures to total volatile organic chemical emissions where reasonable. EPA is working toward defin- ing exposures and risks caused by indoor pollution sources. The ongoing Indoor Air Source Characterization Project will provide a mechanism for EPA to identify indoor air source categories that warrant further evaluation. EPA is assessing the health and environmental risks of selected cleaning products that the U.S. General Services Administration (GSA) purchases for use in gov- ernment buildings. OPPT will assist GSA in developing pro- curement criteria based on effi- cacy, health, and environmental considerations. (See article on page 24.) OPPT continued from page 1 of the changes and initiatives in OPPT. The new approach is designed to maximize the utility of three key OPPT assetsthe expertise of the staff, the assem- bled information on chemicals, and the statutory authorities1 of the officeto achieve results in prevention and risk reduction. The change to a comprehensive pollution prevention program rep- resents a shift away from an activi- ty-based definition of the OPPT program to a broad, integrated, mission-based definition. In the 1 For example, TSCA, EPCRA, PPA (Pollution Prevention Act of 1990) past, OPPT work was primarily organized around section-by-sec- tion implementation of the Toxic Substances Control Act (TSCA). The organization of programs for the TSCA inventory, chemical test- ing, new chemicals, existing chem- icals, and Toxics Release Inventory (TRI) reporting, etc., while pro- viding the needed foundation for a toxics program, has made it diffi- cult to articulate and pursue more broadly based and cross-cutting environmental goals. The articulation of the broad office mission by OPPT's management and staff, has been a key to the shift to a mission-based definition of the OPPT program. The OPPT mission has been defined as: Promoting pollution prevention as a principle of first choice to achieve environmental steward- ship throughout society. Promoting the design, develop- ment, and application of safer chemicals, processes, and tech- nologies in the industrial sector of the economy. Promoting risk reduction and responsible risk management practices throughout the life cycle of major chemicals of concern. Promoting public understand- ing of the risks of chemicals and public involvement in environ- OPPT continued on page 14 D VOL. 14/NO.3 NOVEMBER 1993 ------- I Existing Chemicals Program OPPT continued from page 13 mental decisionmaking through dissemination of information on toxic chemicals. The changes and initiatives that characterize recent OPPT activi- ties reflect an attempt to ensure that OPPT efforts effectively pro- mote the denned mission. A mis- sion-based definition of the OPPT program places the specific imple- mentation of sections of the statutes in the context oflong- term goals. The focus on the broad OPPT mission enables the office to use its resources more flexibly and effectively. This approach has allowed the office to blur the lines between new chemical and exist- ing chemical activities to find new and creative ways to integrate our risk assessment and management experience with our new pollution prevention mandate. For example, test data, expertise in structure- activity relationships, and other assessment tools acquired in the development of the New Chemi- cals Program now frequently con- tribute to decisionmaking in the Existing Chemicals Program. The shift to a mission-based definition of the OPPT program has not weakened the base activities; it has strengthened them by measur- ing their progress in terms of movement toward significant long-term goals, such as reduced risk and pollution prevention. The origins and the outline of the strategy for dealing with chemicals in commerce that have emerged from this new focus on the OPPT mission are discussed below, II. Background and strategy for a common approach to pollution prevention and toxics Finding a means to comprehen- sively address the issues surround- ing "chemicals in commerce" has been the central problem for the EPA toxics program. Dealing with such a large number of chemi- calseither the 70,000 chemicals on the inventory or, sharpening the focus, the approximately 14,000 nonpolymer chemicals produced in amounts above 10,000 pounds per yearhas been a significant chal- lenge. The challenge is especially apparent when one recognizes that the almost countless facilities, use applications, and exposure scenar- ios expand the task beyond the realm of traditional chemical risk management solutions. Moreover, we cannot responsibly assume that all of these chemicals present sig- nificant risk. Clearly, the develop- ment of an adequate method for sorting through these chemicals is one of the central tasks facing OPPT and the nation. OPPT's evolving agenda for toxics OPPT's efforts over the past sever- al years has made considerable progress in the development and implementation of a process for evaluating and making decisions on toxic chemicals. These efforts have been successful in helping to set an agenda for the OPPT Exist- ing Chemicals Program. The OPPT agenda has been developed from reactive, collaborative, and proactive elements. The reactive element of the OPPT agenda, the traditional TSCA agenda, is made up of chemicals brought to the attention of OPPT through TSCA statutory authori- ties such as TSCA section 8(e) sub- missions or recommendations from the Interagency Testing Commit- tee. In the collaborative element of the agenda, OPPT uses TSCA tools and approaches to help other EPA programs on important parts of their environmental agendas. Examples of the collaborative part of the OPPT agenda include work on phosphoric acid production waste, a joint project with EPA's Office of Solid Waste and Emer- gency Response, and the testing of Clean Air Act Amendment chemi- cals. In the proactive element of the OPPT agenda, the office devel- ops its own agenda focused on par- ticular policy or risk concerns in which the agency has otherwise shown an interest. Recent exam- ples include the work with indoor air contaminants, high-release TRI facilities, and persistent bioaccu- mulators. The recently instituted Design for the Environment (DfE) program is also a major component of this proactive agenda. OPPT intends to continue these types of efforts but believes they need to be placed in a larger framework of work on chemicals in commerce. We need to assure our- selves and the constituencies the program serves that we have devel- oped a rational overall agenda for our work on existing chemicals that maximizes pollution preven- tion and risk reduction. D CHEMICALS IN PROGRESS ------- I Existing Chemicals Program Role of government Any effort to address existing chemical issues must also recog- nize that even the most optimistic projection of OPPT resources would allow direct government action on only a handful of the thousands of existing chemicals. Recognition of OPPT's limitations is crucial to any realistic approach to existing chemicals. It is also important to recognize that for many, if not most, chemi- cals of concern significant pollu- tion prevention or other risk reduction gains can be realized with relatively small adjustments in chemical use and management practices. These are the kinds of adjustments that can effectively occur only on an industry-by- industry, community-by-commu- nity, plant site-by-plant site, process-by-process, or chemical application-by-chemical applica- tion basis. The integration of the pollution prevention mandate into the OPPT and EPA programs offers a challenge similar to the task of managing existing chemicals. Pol- lution prevention cannot be dis- tilled into a few big issues. Preven- tion is characterized by large numbers of positive and specific actions by those who understand the details of the manufacture and use of chemicals. Pollution preven- tion opportunities need to be pur- sued for each of the issues of con- cern, large and small, that surround the chemicals in com- merce. The limited resources of government can only be applied directly to a limited number of these transactions. OPPT must, as in addressing toxics issues, recog- nize the limits of its resources and face the problem of determining which of the countless pollution prevention opportunities to target with its limited resources. At the same time, however, OPPT has recognized the growing inter- est and involvement of other par- ties in dealing with toxics issues and in pursuing pollution preven- tion outcomes. Included under this heading are numerous state toxics and pollution prevention pro- grams, industry initiatives such as the Chemical Manufacturers Asso- ciation's Responsible Care Pro- gram, and community-level efforts (based in many cases on the right- to-know premise). Despite their different starting points, OPPT and these other parties have over- lapping objectives. New OPPT strategies The challenges facing OPPT in its attempt to integrate its toxics and prevention programs, lead to some common solutions. Clearly, any realistic plan to address the over- whelming issues and prevention opportunities surrounding chemi- cals in commerce must be designed to facilitate initiative in the private sector, in state and local govern- ments, in labor unions, and in the public. Just as clearly, the overall strategy must include the identifi- cation of priorities so that resources, both of OPPT and of others, can be effectively targeted. Based on these key points, the new OPPT approach for accomplishing its mission is organized around the following three strategies: 1. Empowering the broadest possi- ble initiative from industry, the public and government agencies by providing information and support. 2. Establishing, in conjunction with others, national goals and measures of progress for address- ing toxic chemical issues. 3. Targeting direct OPPT action to areas of high priority to aug- ment ongoing public and pri- vate sector efforts or require activity in areas where initiative is either lacking or insufficient. In carrying out the above strate- gies, OPPT will give special priori- ty to collection and dissemination of environmental information. The OPPT focus on information follows from the recognition of the critical role of information access to the success of others' plans for address- ing toxics issues. The OPPT focus on collecting and disseminating information is not a retreat from government regulation; there will always be a need to use government regulatory processes to address sit- uations where private parties are not responding to environmental issues responsibly. The emphasis on information dissemination is sim- ply a recognition that in the cur- rent environment a large number of private and other public organi- zations are able to develop and implement sound pollution pre- vention strategies to reduce risk. OPPT continued on page 16 VOL 14/NO.3 NOVEMBER 1993 ------- Existing Chemicals Program OPPT continued from page 15 III. Empowering the public with information The most effective way for OPPT to encourage and empower private initiative is to deliver key environ- mental information to industry and the public. The public release of important environmental data gives everyone the ability to par- ticipate in the broader national effort to address chemical issues. The TRI clearly illustrates the ability of information to dramati- cally promote and empower initia- tives by the toxics community. TRI has helped industry to identi- fy problems and target actions, and it has given the public an opportu- nity to learn about problems and become involved in their solution. OPPT will work to provide access to information on facilities, chemi- cals, and uses. For facilities, OPPT will continue to publish and improve the TRI. The recent addi- tion of site-specific pollution pre- vention information will increase the usefulness of this tool. Publica- tion of the Existing Chemicals Program's Risk Management (RM) analysis of targeted high-release facilities will continue. For the future, OPPT has begun a major effort to expand the TRI, which will at a minimum include the addition of chemicals and industri- al sources to the TRI. OPPT will also explore integration of its data- base with others in the agency to provide as complete a picture as possible of releases from facilities. For information on the chemicals of greatest concern, OPPT will continue to make public the chem- ical-related data and information collected and generated through the various authorities of the office such as TSCA section 8 reporting, the testing program, the New Chemicals Program, and the Exist- ing Chemicals Program's RM process. Efforts to improve infor- mation collection and make it more accessible to the public are ongoing. CBI reform to improve public accessibility, exploration of methods for disseminating the 8(e) CAP information, and efforts to work with industry to collect bet- ter exposure information for the RM process are currently in progress. The collection and dissemination of information on chemical use will be a priority for OPPT. Details of the OPPT proposal for collecting use information through a Chemical Use Inventory are dis- cussed in later sections of this paper. In each of the above areas, the col- lection and dissemination of pollu- tion prevention information is essential. Pollution prevention information added to TRI by the Pollution Prevention Act will help to identify prevention opportuni- ties at the facility level. For chemi- cals of concern, the assembly of more complete hazard and expo- sure information will ensure that where prevention is denned as chemical substitution, the public can be more confident that safer materials are being used. Perhaps most importantly, the OPPT focus in the RM and DfE programs on chemical uses instead of individual chemicals will provide an effective means for uncovering and promot- ing pollution prevention opportu- nities. Further development of the pollution prevention clearinghouse and dissemination of DfE informa- tion will also encourage pollution prevention in the private sector. Analytical tools developed by OPPT will also be made available to the public. Details of the risk management screening analyses and the DfE chemical substitute assessment methodology are now being packaged for public use. Other tools and models, such as software to estimate the aquatic toxicity of chemicals, are being modified so they can be used by others outside EPA. IV. Establishing national goals and measures of progress Defining the chemicals, facilities, processes, and chemical uses of most concern and setting national goals are essential to a successful toxics program. Current OPPT efforts to set goals and measures of progress include the TRI and the 33/50 Program, as well as the Master Testing List. The proactive agenda of the RM process, dis- cussed above, has also helped to clarify national goals with its cur- rent focus on indoor air pollutants, high-release TRI facilities, and persistent bioaccumulators. Based on these efforts, it now seems appropriate to develop a more systematic, collaborative and com- prehensive approach to this goal-setting process. OPPT is not now in the position D CHEMICALS IN PROGRESS ------- Existing Chemicals Program to articulate comprehensive, broadly applicable, specific goals for chemical risk reduction. OPPT is, however, engaged in a major strategic effort that will provide EPA with a sound technical basis for setting priorities and denning environmental goals. Specifically, OPPT has under way two projects: Developing a method to screen chemicals in commerce to iden- tify those of most concern. Identifying the patterns of chemical use that are of most concern. The effort to screen chemicals begins by identifying high- and moderate-volume chemicals with significant hazard concerns. Use information will then be used to identify chemicals with high-exposure potential, such as those used in consumer products or handled by large numbers of workers. To collect information on exposure potential, OPPT is in the process of evaluating how the TSCA Inventory Update Rule can be amended to generate a Chemi- cal Use Inventory. (Details of pro- posals for a Chemical Use Invento- ry and a comprehensive screening method can be found in the final section of this paper.) Following the identification of the chemicals of most concern, OPPT will work to assure that basic information on the hazards and exposures associated with these chemicals is available to the pub- lic. OPPT will also work to pro- vide the public, through a combi- nation of government and private efforts, with analyses of the risks associated with these chemicals and with pollution prevention and risk management strategies that can be adopted to mitigate con- cerns. Identification of the chemi- cals of most concern and the col- lection and dissemination of information on these chemicals will help to focus national efforts to areas where they can be most effective. As a complement to this effort, OPPT will also work to identify the patterns of chemical use that are of most concern. OPPT has already developed the basics of a scoring system that ranks potential concerns associated with chemicals used in the same application or use clusters. This system accesses read- ily available information on expo- sure and hazard. An algorithm, based on past OPPT risk screening experience, is then used to gauge potential concerns. Using the scor- ing system to help identify the chemical uses of most concern will help to focus pollution prevention and risk management efforts to priority areas. The identification of priority uses will also help to direct research and other private and public efforts to areas where they can be most effective. V. Targeting government action Current OPPT direct actions are usually targeted using risk, expo- sure, and hazard criteria. Actions can be organized by specific chem- icals, by clusters of chemicals defined by concern or use, or by facilities and industries. Targeted concerns are analyzed in the RM process of the Existing Chemicals Program and appropriate pollution prevention or other risk manage- ment approaches, either voluntary or regulatory, are developed. Use clusters While review of individual chemi- cals of concern will continue, OPPT currently emphasizes the targeting of use clusters for review. Use clusters, which focus on a spe- cific chemical use and the alterna- tives available for that use, pro- mote consideration of major factors that are needed for the develop- ment of pollution prevention or other risk management plans. As a result, use cluster reviews can be more helpful to chemical users than single chemical reviews. The current RM review of aerosol spray paints illustrates this point. The cluster was chosen to address the Science Advisory Board's choice of indoor air as a potential priority risk area. Focus on the use of aerosol spray paints as a group allows the review process to gather all the necessary information on chemicals and alternatives that will provide the basis for pollution prevention or other risk manage- ment approaches. OPPT's DfE program builds on the use cluster approach by focus- ing on specific uses and expands beyond the RM process to include the active involvement of a willing industry. In DfE efforts, OPPT works with all sectors of an indus- try to develop a long-range plan for the identification and imple- OPPT continued on page 18 VOL 14/WO.3 NOVEMBER 1993 ------- Existing Chemicals Program OPPT continued from page 17 mentation of pollution prevention or other risk reduction plans. The printing, dry cleaning, and com- puter industries are working with OPPT on Dffi projects. In addition to direct work with chemical manufacturers and users, OPPT targets its own resources, through the Source Reduction Review Project, to assist other EPA program offices in identifying opportunities for incorporating pollution prevention into regula- tions affecting 17 industrial source categories. (See article on page 28.) In the future, direct OPPT actions will be able to take advantage of public tools, such as the Chemical Use Inventory comprehensive screening, to more clearly identify high-priority use patterns, facili- ties, and chemicals for RM action. OPPT will continue to select such cases for entry into its Existing Chemicals Program, where we can achieve risk reduction through a combination of regulatory and vol- untary actions. VI. Chemical use inventory and comprehensive screening proposals The Chemical Use Inventory would amend the current TSCA Inventory Update Rule to include basic information on chemical use. This inventory proposal is a clear example of the kinds of initiatives that develop out of the combina- tion of the toxics, pollution pre- vention, and information perspec- tives of the new OPPT strategy. The OPPT toxics program has from its inception been faced with the need to find an adequate process to sort through the 70,000 chemicals on the inventory to identify the chemicals of greatest concern. The current inventory update rule collects some of the key information, such as produc- tion volumes, to identify the chemicals of concern, but informa- tion on the use of chemicals, which is essential to determining possible exposure routes and scenarios and potential safer substitute chemi- cals, is not covered by the Inven- tory Update Rule. With modifica- tions to include basic information on chemical uses, the inventory update could supply information essential to an effective TSCA inventory screening program. To enhance the value of the data, OPPT is considering broadening the scope of the industries that report, increasing the frequency of reports (e.g., every two years) and placing the reporting cycle on the same timeframe as TRI reporting. The proposed screening would identify chemicals of concern via the following criteria: High-volume chemicals (those produced annually in amounts greater than 1 million pounds a year) of more that low hazard. Moderate-volume chemicals (those produced annually in amounts of 10,000 pounds to 1 million pounds) of relatively high potential hazard, potential consumer use, or high potential occupational exposure. Appropriate criteria for the high- and low-hazard points, consumer use, and high potential occupa- tional exposure would also need to be developed. Agreement of the toxics communi- ty on a screening tool based on the Chemical Use Inventory would produce a list of chemicals of greatest concern that could serve as the basis for a national agenda for toxics. Instead of an unmanageable list of 70,000 chemicals, the nation would have a list of the sev- eral thousand chemicals of greatest concern. This would help to focus limited resources to the areas of greatest need. Based on this agen- da, clear and measurable national goals for information collection, pollution prevention, and other forms of risk management could be established. The evolution of the OPPT infor- mation strategy also leads to the Chemical Use Inventory. TRI emissions information has empow- ered industry and the public to identify problems and set clear goals for addressing toxics con- cerns in the areas of the manufac- ture and processing of chemicals. Progress in this area has led natu- rally to consideration of the areas of concern not covered by TRI, in particular, the exposures and risks associated with chemical use. The Chemical Use Inventory would provide the basic use information necessary to expand the public ini- tiatives around the TRI to the area of chemical use. The issue of confidential business information (CBI) will be a key consideration in implementing a Chemical Use Inventory initiative. While accommodating legitimate m CHEMICALS IN PROGRESS ------- I Existing Chemicals Program / Export Notification CBI concerns, the Chemical Use Inventory, in order to achieve the objectives of empowering the pub- lic, would emphasize public access. One possible way to accommodate competing interests would be to require reporting at a more detailed level to allow EPA to use the data for chemical screening while providing public disclosure at a more aggregated level that would overcome most CBI issues while still providing the level of information needed for public tracking. The ability to use the Chemical Use Inventory to identify trends and patterns of chemical use are also key to pollution prevention. Pollution prevention gains in the area of chemical use require detailed consideration of specific chemical applications. The Chemi- cal Use Inventory would help to identify the use areas of greatest concern and allow for the effective targeting of pollution prevention efforts. The Chemical Use Invento- ry could also be used to set goals and measure the progress of pollu- tion prevention for chemicals in commerce. In sum, the Chemical Use Inven- tory and the accompanying screen- ing proposal are examples of the kinds of initiatives that result from the new OPPT strategy. The pro- posals are designed to assist with setting goals, empowering private initiative, and targeting OPPT actions. They also provide key building blocks for the advance- ment of pollution prevention. EPA Amends Notification Rule for Chemical Exports EPA has changed one of the annual reporting requirements of its export notification rule. The change affects reporting on chemi- cals subject to test rules under sec- tion 4 of the Toxic Substance Con- trol Act (TSCA). As of January 1, 1994, companies are required to provide a one-time notice to EPA for each country to which they export a TSCA section 4 chemical. Previously, companies were required to provide annual notices. At the same time, EPA will begin notifying foreign gov- ernments of the import of each chemical only once, instead of annually. Reporting requirements for sections 5, 6, and 7 of TSCA remain unchanged. Background of TSCA section 12(b) program In 1980, EPA began requiring notification for the export of cer- tain chemicals, as mandated by section 12(b) of TSCA. In addition to chemicals that are subject to TSCA section 4 test rules, notifica- tion is required for chemicals that are subject to: Submission of test data under TSCA section 5(b) Consent orders issued under TSCA section 5 Significant new use rules (SNURs) or proposed SNURs under TSCA section 5 Rules or proposed rules under TSCA section 6 Pending actions or granting of relief under TSCA section 5 or section 7 EPA sends the notices to the importing country to alert it that a chemical is subject to regulatory actions in the United States. Since the program started, the volume of notices submitted to EPA has increased significantly, as have the notices EPA sends to foreign gov- ernments. By the end of 1993, EPA expects to receive more than 15,000 notices; about 12,000 of these are for TSCA section 4 chemicals. The increasing number of notices is making it difficult for foreign governments to review and moni- tor imported chemicals. Decreas- ing the number of notices for TSCA section 4 chemicals will allow foreign governments to focus their efforts on imported chemicals that are subject to restrictive regu- lations or proposed restrictive reg- ulatory actions. For more information Call or write to the TSCA Hotline (see page 43). See 40 CFR part 707 for the TSCA section 12(b) export notification rule. See 58 FR 40238, July 27, 1993, for the amendments to the reporting requirements of the TSCA section 12(b) export notification rule. VOL14/N0.3 NOVEMBER 1993 ------- I Existing Chemicals Program States Support Efforts on Forming Voluntary Agreement on Pulp and Paper Mill Sludge EPA is negotiating a voluntary agreement with the American For- est and Paper Association to estab- lish dioxin and furan standards and management practices for the use of sludge as a soil conditioner. The association is representing pulp and paper mills that currently land-apply the sludge. The proposed agreement would establish three standards for dioxin and furan concentrations in pulp and paper mill sludge. The stan- dards are: A maximum dioxin and furan concentration, or "cap," for sludge that can be land-applied A dioxin and furan concentra- tion at or below which sludge would be exempted from most provisions of the agreement A maximum dioxin and furan soil concentration that may not be exceeded for land on which sludge is applied. EPA is interested in setting dioxin standards that are acceptable to states that allow land application. At the June 1993 meeting of the Forum on State and Tribal Toxics Action, representatives from 10 of these states said they agreed with the standards' framework. Some states also expressed interest in incorporating dioxin and furan standards into their existing efflu- ent regulations for mills. Pulp and paper mills would be required to meet these standards to remain in compliance with effluent permits. Concern about contaminated sludge In 1985, EPA found that the man- ufacture of chlorine-bleached pulp and paper produces dioxins and furans. These chlorinated organics are highly toxic and are classified by EPA as a probable human car- cinogen. While pulp and paper EPA believes that improper land application of pulp and paper mill sludge can pose a significant risk to wildlife. products themselves contain negli- gible levels of dioxins and furans, EPA determined that pulp and paper mill sludge produced in manufacturing these products may be of concern. In the United States, 104 facilities use chlorine or chlorine derivatives to manufac- ture bleached pulp. In 1991, EPA proposed a regula- tion under the Toxic Substances Control Act (TSCA) to (1) limit the concentration of dioxins and furans in soil to 10 parts per tril- lion and (2) establish site-manage- ment practices for land application of the sludge. EPA deferred finalizing the rule until issuance of integrated regula- tions for effluent guidelines and Most Achievable Control Technol- ogy (MACT) standards. These reg- ulations will require bleach plant process changes in the pulp and paper industry and are expected to reduce the concentration of dioxins and furans in sludge. Concentra- tions may be reduced to a level that would make TSCA rulemak- ing unnecessary. EPA believes that improper land application of pulp and paper mill sludge can pose a significant risk to wildlife. The voluntary agree- ment would be the first part of an environmental stewardship pro- gram that EPA is proposing for the pulp and paper industry. The stew- ardship program would ensure responsible land application and greatly reduce potential risks from land-applying pulp and paper mill sludge. CHEMICALS IN PROGRESS ------- I Existing Chemicals Program Public Meeting Held on TSCA CBI Reform About 60 people attended a public meeting in July 1993 on reform- ing confidential business informa- tion (CBI) policies for data sub- mitted under the Toxics Substances Control Act (TSCA). In May 1993, EPA's Office of Pol- lution Prevention and Toxics (OPPT) proposed a series of short- and long-term actions to address the problem of inappropriate CBI claims. OPPT sponsored the pub- lic meeting to elicit comment on its proposed actions. At the public meeting, 16 repre- sentatives from various constituen- cies spoke about the proposed actions to address inappropriate claims. Among the speakers were representatives from the Illinois EPA, the Chemical Manufacturers Association, the Sierra Club, the AFL-CIO, the Dow Chemical Company, and the World Wildlife Federation. By and large, the speakers recognized that CBI claims made without regard to statutory and regulatory right are not desirable. Several industry speakers noted that there are some improper filings and that these need to be limited. There was dis- agreement, however, about the number of these improper filings. All parties agreed that it would be helpful if EPA would issue clear guidelines on making CBI claims and that education courses on the subject would be useful. But the speakers disagreed on the appropri- ateness of regulatory amendment. OPPT will consider all public comments before publishing a final TSCA CBI action plan. EPA's Office of Pollution Prevention and Toxics (OPPT) proposed a series of short- and long- term actions to address the problem of inappropriate CBI claims. Background of CBI reform Over the past several years, OPPT has sought broad participation in toxics management. To understand the risks from chemical substances, however, the public requires access to TSCA data. There is wide agree- ment that dissemination of these data is consistent with the lan- guage and intent of the statute. Inappropriate CBI claims limit the toxics data available to the public and hamper efforts (1) to promote public education about chemicals and (2) to encourage public partic- ipation in toxics control. OPPT has committed itself to making toxics data available to the public and states. For more information Two documents are available by calling the TSCA Hotline at (202) 554-1404 or by writing to the address on page 43: (1) OPPT's Proposed Actions to Reform TSCA Confidential Business Infor- mation and (2) Influence of CBI Requirements on TSCA Implemen- tation, a contractor study com- missioned by OPPT. Public comments on the TSCA CBI reform effort are contained in the administrative record, docket number OPPTS 00124, in OPPT's Non-Confidential Information Center. To contact the information center, call (202) 260-7099. For additional information, con- tact Scott Sherlock, in OPPT's Information Management Divi- sion; telephone, (202) 260-1536 or (202) 260-1657; or, write to him at the address on page 43. B VOL 14/NO.3 NOVEMBER 1993 ------- Information Management OPPT Proposes New Strategy for Information Management Written Comments Sought Making toxics information avail- able to the public is integral to both the management of toxic chemicals and the promotion of pollution prevention. EPA's Office of Pollution Prevention and Toxics (OPPT) recently drafted a strategy for improving the management and accessibility of toxics data. OPPT is soliciting comments on the strategy through this article and meetings with industry, public interest groups, state officials, and other EPA offices. The final strate- gy will be based on careful consid- eration of all comments. The strategy is organized around six goals and provides a broad framework for all the activities that OPPT plans to undertake. A summary of the six goals follows. 7. Increase awareness throughout EPA of the importance of informa- tion collection, processing, and dis- semination; incorporate an infor- mation product focus in all OPPT activities. OPPT has a storehouse of useful toxics data collected under various federal laws. The data include exposure, hazard, risk, and other relevant information and are essen- tial for making decisions about chemical risk reduction, risk man- agement, testing needs, and pollu- tion prevention. Also essential is how these data are managed, including how they are compiled, stored, and delivered. The impor- tance of data management must be clearly expressed to OPPT staff, managers, and outside parties to ensure the success of OPPT pro- grams. To maximize the benefits of the information, OPPT must orga- nize it in useful and accessible products, such as computer diskettes, written reports, and CD- ROMs. At every stage of OPPT programs, from start to finish, the information products must be con- sidered and understood. This awareness must be conveyed throughout EPA as OPPT works to integrate its data with other data sources in EPA. 2. Expand and enhance OPPT's relations with constituents. To achieve the goals of OPPT, there must be a true partnership between OPPT, other EPA offices, the federal government, other countries, the states and tribes, industry, and the public. To achieve that partnership, it is essential that OPPT adopt a cus- tomer-oriented focus, communi- cating with both the providers and users of information. OPPT must continually evaluate its services and products with both suppliers and customers in mind. 3- Widely distribute and provide easy public access to meaningful infor- mation, thereby providing a model for government, Information is truly power. OPPT must take all necessary steps to ensure meaningful access to its Statutes Under Which OPPT Collects Data Toxic Substances Control Act Emergency Planning and Community Right-to- Know Act Pollution Prevention Act substantial stores of information and tools. They should be pack- aged in user-friendly and accessible products that are marketed and distributed to the public. Where possible, information should be integrated with other pertinent data. The information must be dis- seminated in a manner consistent with OPPT's statutory mandates, including the adequate protection of confidential information. 4. Establish standards for informa- tion quality and establish a process for achieving them. OPPT strives to provide informa- tion that is reliable, accurate, and up to date. The data collected and disseminated must be of sufficient quality for the intended purposes, with consideration for broader uses over its entire lifecycle. OPPT will establish appropriate data-quality New Strategy continued on page 23 CHEMICALS IN PROGRESS ------- I Information Management New Strategy continued from page 22 standards and let users know how well the data meet the standards. 5. Develop enhanced capabilities to allow OPPT and its constituents to analyze and use information more effectively. Analytical capabilities are essential for OPPT to accomplish its pro- gram goals. These tools must be scientifically credible, current, and well documented. Tools and infor- mation systems must be developed and maintained in accordance with accepted standards for information resources management. 6. Invest in and apply human and technological resources to achieve efficiency in information management. OPPT must increase its efficiency by investing in information tech- nology, including computer plat- forms, applications, and mainte- nance. Most importantly, however, OPPT must invest in people. OPPT must continually evaluate information management responsi- bilities to ensure adequate staffing and training. Because contractors represent a large part of OPPT's total information management resources, it is essential that OPPT continually improve management of them. To provide written comments OPPT will base its final informa- tion-management strategy on care- ful consideration of all comments. Written comments can be submit- ted to Andrew Wheeler, of OPPT's Information Management Division (7407), 401 M Street, S.W., Washington, D.C. 20460 Workshops on Confidential Business Information Offered The Chemical Manufacturers Asso- ciation (CMA) is offering work- shops on how to make effective confidential business information (CBI) claims on submissions to EPA under the Toxic Substances Control Act (TSCA). EPA's Office of Pollution Prevention and Toxics (OPPT) is participating in the workshops. The workshops will cover the sig- nificance of CBI; its value to industry, EPA, and the public; how inappropriate CBI claims lim- it public access to information; applicable law and regulations; allowable claims content; criteria for substantiation; procedures to assure claim validity; generic nam- ing; and EPA screening practices. In 1992, EPA determined that some CBI claims in TSCA submis- sions do not appear to be fully sup- portable under the statute. EPA subsequently identified CBI claim procedures as an area that could be improved through voluntary industry actions, public dialogue, and education. Locations and dates. Two-day workshops are planned for Washington, D.C., on December 1 and 2, 1993; for Houston, Texas, on February 23 and 24, 1994; and for Newark, New Jersey, on June 16 and 17, 1994. Who should attend. Anyone who submits TSCA section 5 premanufacture notices (PMNs), TSCA section 8(e) notices of substantial risks, TSCA section 8(d) health and safety studies, or data under TSCA 8(a), the inventory update rule. For more information For additional information, call Charles Walton, of the CMA, at (202)887-1365. VOL. 14 /N0.3, NOVEMBER 1993 ------- Design for the Environment Before Buying, GSA to Check Custodial Products' Health and Environmental Effects Products Could Be Used In Thousands of Government Buildings At least one U.S. agency plans to use its purchasing power to advance pollution prevention. The General Services Administration (GSA) plans to buy cleaning prod- ucts for the government buildings it services only if the products meet certain efficacy, health, and envi- ronmental standards. EPA's Office of Pollution Preven- tion and Toxics (OPPT) is helping GSA's Public Buildings Service (PBS) to organize and implement this effort. Using the Existing Chemicals Program's Risk Manage- ment process, OPPT is assessing the health and environmental risks of selected cleaning products. Later, OPPT will assist PBS in develop- ing procurement criteria based on efficacy, health, and environmental considerations. Leading edge in acquisition policies This effort may have long-term implications. On October 20,1993, President Clinton signed an execu- tive order requiring the federal gov- ernment to incorporate environmen- tal considerations in its acquisition policies. GSA's Federal Supply Ser- vice will be required to use environ- mental criteria to select the prod- ucts that it supplies throughout the federal government. While the full implications of their efforts within the context of the executive order must still be determined, OPPT and PBS expect that their selection criteria will be suitable for incorpo- ration into the Federal Supply Ser- vice system. Cleaning products that meet the selection criteria will reduce pollu- tion that now occurs during manu- facturing, packaging, use, or dis- posal. If the U.S. government buys these cleaning products, so the thinking goes, other parts of the public and private sectors will demand products that meet similar standards. The demand would motivate manufacturers to design into their products steps that will prevent pollution. This approach is at the core of OPPT's Design for the Environment (DfE) program. Project phases OPPT and PBS are following a multiphased process to develop environmental and health criteria for custodial products. PBS select- ed all-purpose cleaners, floor care products, carpet cleaning products, snow removal products, and sweep- ing compounds for evaluation first. An example of how the criteria will be developed is described below. 1. OPPT is currently assessing the environmental and health effects of three sets of cleaning products. These products are also being tested at a building that GSA services. Among the considerations in selecting these products is that they are concentrates. From PBS's point of view, a one-gallon container of a concentrated product is easier to store and handle than a 55-gallon drum. From an environmental point of view, concentrated products dramat- ically decrease packaging and disposal needs. 2. In conjunction with the prod- uct assessments, OPPT and PBS are developing criteria for selecting custodial products that have the most favorable combinations of efficacy, human health, and environ- mental safety. Interested par- ties will be invited to partici- pate in the development of criteria. Development of voluntary standards OPPT's DfE program and PBS are encouraging manufacturers of all products to develop and imple- ment voluntary criteria to prevent pollution. The OPPT/PBS teams may work with the American National Standards Institute to develop voluntary criteria that would meet the needs of the federal civilian and military supply sys- tems. All interested parties are wel- come to participate in this effort. For more information To find out more about the activi- ties described in this article, call Conrad Flessner, of OPPT's Exo- nomics, Exposure, and Technology Division, at (202) 260-3918, or write to him at the address on page 43. ffl CHEMICALS IN PROGRESS ------- Design for the Environment Update: Design for the Environment Program EPA's Design for the Environment (DfE) program is stimulating pri- vate sector efforts to design prod- ucts and services that reduce potential risks from chemicals. DFE programs involve industry, trade groups, and environmental groups in cooperative projects to promote environmental protec- tion. Current DfE programs focus on the printing industry, the dry cleaning industry, and the finan- cial business community. The Office of Pollution Prevention and Toxics (OPPT) administers the DfE program. Risk ranking workshop A summer workshop kicked off DfE efforts to identify a framework for ranking the health and envi- ronmental risks from chemicals and products used in printing. The workshop was the first step in coordinating the different ranking methods being developed by industry, universities, and EPA. Currently, the lack of standardized methods for comparing chemicals and product formulations impedes efforts to (1) design products and services that are better for the environment and (2) quickly screen and rank environmental impacts of existing products and services. Workshop proceedings are available from the Pollution Prevention Information Clearing- house (PPIC) at (202) 260-1023. Printing project The printing project is focusing on developing comparative informa- tion on the risks, exposures, per- formance, and costs of cleaning products and inks used in three methods of printing: lithography, screen printing, and flexography. Lithography The project has become involved with the Great Printers Project, sponsored by the Environmental Defense Fund, Printing Industries of America, and the Council of Great Lakes Governors. The Great Printers Project will communicate DfE information to lithographers in eight Great Lake states as part of a larger effort to develop region- al and local outreach contacts with craft shops and local printers who are making environmental strides. Screen Printing Screen printers use a process called screen reclamation to remove the ink, stencil, and ghost image from screens. During this process, recla- mation chemicals and residue ink are often washed directly down the drain. The DfE printing project is evaluating the health and environ- mental risks associated with differ- ent chemicals (including those labeled "biodegradable" or "drain safe"), work practices, and techno- logical alternatives. Flexography Several preliminary meetings with the flexography sector of the print- ing industry have been held to begin investigating alternatives for work practices involving inks and for chemicals used in inks. Financial business community projects Three DfE projects are concerned specifically with integrating envi- ronmental factors into general business practices. These projects focus on the financial business community, since financial consid- erations drive nearly all business decisions. Pollution prevention financing New pollution prevention tech- nologies cannot be developed and implemented without the avail- ability of financing. EPA is form- ing a pilot program to test the fea- sibility of including financial counseling in state technical assis- tance programs for pollution pre- vention. This will aid businesses, especially small and mid-sized firms, that lack the resources to package their loan requests in a convincing manner. The DfE pro- ject also plans to begin outreach to the financial community which tends to associate environ- mental investments with liability on the opportunities and value provided by pollution prevention investments. Accounting and capital budgeting Experts who are active in improv- ing managerial accounting and capital budgeting practices will meet at a December workshop. The objective of the workshop is to discuss issues involved in incorpo- rating environmental factors into managerial accounting and capital Update continued on page 26 VOL. 14/NO.3 NOVEMBER 1993 ------- I Design for the Environment Update continued from page 25 budgeting practices and to develop a strategy to promote needed changes in these fields. The work- shop is sponsored by EPA, the U.S. Chamber of Commerce, the Amer- ican Institute of Certified Public Accountants, the Institute of Man- agement Accountants, and AACE International, which is an associa- tion for cost engineers. Insurance and risk management EPA is working with the American Insurance of Chartered Property and Casualty Underwriters (AICPCU) to incorporate pollution prevention into its certification program for Associates in Risk Management. AICPCU offers edu- cation and professional certification to people in the property and lia- bility insurance field. EPA is also examining other opportunities to incorporate pollution prevention into the risk management profes- sion and the insurance industry. For more information For information about DfE speak- ers or to obtain materials about DfE projects, contact EPA's Pollu- tion Prevention Information Clear- inghouse (PM-211 A), U.S. EPA, 401 M Street, S.W., Washington, D.C. 20460; telephone, (202) 260-1023; FAX, (202)260-0178. New case studies are available about the successful pollution prevention efforts of a Minnesota lithographer and a Wisconsin screen printer. New materials about integrating pollution prevention into account- ing systems and capital budgeting practices are also available. EPA Completes Study of Dry Cleaning Demonstration Project EPA has completed a study com- paring the cost and performance of dry cleaning with an alternative process that uses heat, steam, and natural soaps to clean clothes. In general, the results of the study indicate that the alternative processcalled wet cleaningis a viable option for some segments of the dry cleaning industry. The purpose of the study was to evaluate a process that could decrease exposures to perchloroeth- ylene, often referred to as "perc." Perc is a chemical solvent used by most dry cleaners. Dry cleaners are one of the largest groups of chemi- cal users that come in direct con- tact with the public. In November and December 1992, EPA's Design for the Environment (DfE) program and the dry clean- ing industry collaborated on a demonstration in which 1,500 gar- ments were cleaned using either the standard dry cleaning method or wet cleaning. After cleaning, both sets of clothes were pressed on the same equipment and returned to the consumer. Includ- ed with each garment was a postage-paid form for consumers to use to indicate their satisfaction with the cleaning of their garment. Consumers were not informed of which process was used to clean their clothes. Comparisons of customer satisfac- tion and fabric wear found little statistical difference between the two processes, aside from a slight customer preference for the lesser odor from clothing cleaned with the wet cleaning process. Effects of the wet process over the long term were not tested and are unknown. The total estimated costs of the wet cleaning process are slightly less than the standard dry cleaning process. Although the wet clean- ing process requires more than three times the skilled labor in the cleaning phase, this cost is offset by the higher annualized costs of equipment, hazardous waste dis- posal, electricity, and supplies needed in the dry cleaning process. In addition, EPA projections show that converting an existing dry cleaning plant to a facility capable of using both cleaning methods or building a new wet cleaning facili- ty are both technically feasible and economically competitive. For more information: For more information about the EPA's study of the dry cleaning demonstration, call the Pollution Prevention Information Clearing- house at (202) 260-1023. CHEMICALS IN PROGRESS ------- Design for the Environment Consideration of Alternate Synthetic Pathways Is Incorporated Into Some PMN Reviews EPA has expanded its analysis of new chemicals to include a source- reduction review of synthetic path- ways. The objective is to find ways to reduce the use of toxic feed- stocks and to prevent production of toxic byproducts. This approach is in sync with the objective of the Pollution Prevention Act of 1990 to prevent pollution or reduce it at its source whenever possible. In its assessment of a chemical's synthetic pathway, EPA uses infor- mation provided by manufacturers in premanufacture notices (PMNs). Federal law requires PMNs for new chemicals before production or marketing. Determining which chemicals are reviewed In assessing new chemicals for source-reduction opportunities, EPA's Office of Pollution Preven- tion and Toxics (OPPT) focuses on nonpolymer chemicals produced in volumes of at least 25,000 kilo- grams a year. Excluded from the source-reduction review are com- plex reaction mixtures and sub- stances that qualify for test mar- keting exemptions, low-volume exemptions, and polymer exemp- tions. During a two-stage screen- ing and assessment, OPPT per- forms the following steps: Determines the sources, identi- ties, and quantities of the wastes generated during chemical syn- thesis prior to treatment or disposal. Determines if any of these wastes are regulated substances or are classified as extremely toxic. Determines if the solvent used in synthesizing the chemical is potentially hazardous and if it is recycled. Assesses whether any of the byproducts generated during production are potentially hazardous. Determines whether the amount of any single Toxics Release Inventory chemical present in any process stream is equal to or exceeds 11,340 kilograms each year. If specific conditions are met, the PMN chemical is sent to the next stage of assessment. During this stage, OPPT examines possible causes for the generation of haz- ardous wastes and ways to elimi- nate or significantly reduce the volume of those wastes to a level at which they no longer pose poten- tial risks to human health or the environment. Examples of options for reducing wastes include the use of: In-process recovery and recy- cling of the solvent. Recovery and recycling of unconsumed reactants. Purer reactants and solvents. More selective catalysts that create fewer byproducts or impurities. Lower temperatures or longer time periods to increase yields. more efficient separation processes to purify the new chemical. Alternate feedstocks or alternate synthetic pathways. Early results Between January 1993 and June 1993, EPA conducted a source- reduction review for about 5 per- cent, or 75, of the approximately 1,500 PMN chemicals reviewed. In these 75 cases, EPA's chemists specifically evaluated how synthe- sis of the chemical would generate pollution. They developed alter- nate methods of synthesis or found ways to apply new pollution-pre- vention technologies in a number of these cases. EPA has notified the manufactur- ers of the chemicals by letter that source reduction is possible. In the letter, EPA specified its con- cerns on the particular chemical and the options that can be implemented to prevent pollution at its source. It is up to the manu- facturer to put these options into practice since the program is completely voluntary. VOL. 14/NO.3 NOVEMBER 1993 ------- I Pollution Prevention Activities New EPA Project Integrates Source Reduction into Rulemaking EPA's new Source Reduction Review Project is laying the groundwork for building pollution prevention into rulemaking. The project is analyzing 24 proposed standards to determine how to develop regulations that will encourage industry to use source- reduction options. The 24 stan- dards affect 17 industrial cate- gories. (See accompanying list.) EPA's Pollution Prevention Senior Policy Council initiated the Source Reduction Review Project after Congress passed the Pollution Pre- vention Act of 1990. The act directed EPA to determine how proposed regulations would affect source reduction. The term "source reduction" refers to reducing the amount of pollutants that enter a waste stream or are otherwise released into the environment pri- or to recycling, treatment, or dis- posal. The Source Reduction Review Project is scheduled to complete analysis of the 24 pro- posed rules in 1999. This is not the first time that EPA has incorporated source reduction into rulemaking. It is the first time, however, that EPA has estab- lished an agencywide process for examining the entire picture before writing rules. This process includes two important factors: Using rigorous technical and economic analysis to compare source-reduction techniques to other controls. Taking into account any cross- Standards Affect 17 Industrial Categories The Source Reduction Review Project is analyzing source-reduction options for 24 proposed rules. The proposed rules include the air toxic standardsknown as MACT standardsset by the Clean Air Act, efflu- ent guidelines set by the Clean Water Act, and the hazardous waste list- ings set by the Resource Conservation and Recovery Act. The proposed rules will affect the following 17 industrial categories: Pesticide formulating Pharmaceuticals production Degreasing operations Printing/publishing Styrene butadiene latex and rubber production Reinforced plastic composites production Plywood and particleboard manufacturing Acrylic fibers/modacrylic fibers Wood furniture manufacturing Pulp and paper production Paint Stripper Users Polystyrene production Rubber chemicals manufacturing Integrated iron and steel manufacturing Machinery manufacturing and rebuilding Paints, coatings, and manu- facturing Adhesives manufacturing Paper and other webs coating media effects and possible impacts on the use of energy and other resources. Review process The project's review process con- sists of three steps. 1. Conduct source-reduction analyses. EPA identifies and evaluates source-reduction measures and other controls through industry surveys, studies, and other means of collecting data. Factors that are considered include confor- mance with statutory authori- ty, performance in all media, cost, energy requirements, and raw materials requirements. 2. Use the analyses to develop regulations. When consistent with its statutory mandates, EPA uses the information from its analyses to develop regula- tions that encourage source reduction. The analyses sup- port development of: Source Reduction continued on page 29 CHEMICALS IN PROGRESS ------- I Pollution Prevention Activities Source Reduction continued from page 28 Standards that are based on or met through source reduction (although specific source-reduc- tion technologies would not be required) Regulatory incentives for adopting source-reduction mea- sures as an alternative means of compliance Guidance materials that accom- pany the final rulemaking to educate permit writers and industry about the performance and cost of source-reduction measures 3. Implement the regulation. EPA will provide permit writ- ers with training and assistance to expedite the review and approval of source-reduction measures as a means of compli- ance. EPA will offer targeted assistance to industry to help identify and implement source-reduction techniques that offer the most cost-effec- tive means of compliance. Pollution Prevention Curricula Developed for Higher Education The National Pollution Prevention Center for Higher Education, located at the University of Michigan, was established in 1991 to help incorporate pollution prevention principles into undergraduate and graduate courses throughout the nation. The national center conducts a range of activities. However, development and dissemination of curriculum modules on pol- lution prevention are its first order of business. The modules can be easily integrated into existing graduate and undergraduate courses. The center has completed and distributed curriculum modules for courses in accounting, business law, industrial and operations engineering, and chemical engineering. Near completion are modules for architecture, cor- porate strategy, operations management, chemistry, and environmental engineering. Other programs The center has organized a National Pollution Prevention Internship Pro- gram. The summer program allows qualified students to work on pollu- tion prevention projects for different organizations. Representatives from the center also participate in conferences to spread information about pol- lution prevention and its place in education. This dialogue helps in dis- tribution of pollution prevention modules to interested parties as well as in ensuring that necessary information is included in the modules. Directory is available A national network of university faculty involved in various aspects of pollution prevention is being used in the dissemination, development, and review of pollution prevention modules. The network is listed in a directory, developed by the University of California at Los Angeles and the National Pollution Prevention Center for Higher Education. To obtain the directory, call the center at (313) 764-1412. OPPT Puts First-Time Integrated Report on Hold In January 1993, EPA's Office of Pollution Prevention and Toxics (OPPT) announced it was integrat- ing a range of information about toxic chemicals into the report Industrial Toxics and Pollution Pre- vention: A National Report. Howev- er, OPPT found integration of these data to be quite complex and decided against trying to develop a single document at this time. Individual components of the report are available to the public in other documents. For example, the analysis of selected Toxics Release Inventory data normalized with economic data is in chapter 3 of the 1991 Toxic Release Inventory: Public Data Release. The document is available from the Emergency Planning and Community Right- to-Know Hotline; telephone, (800) 535-0202; for the Washing- ton, D.C., area, (703) 412-9877; for TDD callers, (800) 553-7672. In addition, several case studies developed for the report were pub- lished in the July/September 1993 issue of the EPA Journal, which became available in October 1993. These case studies show the con- nections between pollution pre- vention and good business. The EPA Journal is available from EPA's Public Information Center at (202) 260-7751. VOL. 14/NO.3 NOVEMBER 1993 ------- I Pollution Prevention Activities / 33/50 Program 33/50 Program Achieves 1992 Reduction Goal One Year Early Releases and transfers of 17 toxic chemicals declined by 34 percent from 1988 to 1991, meeting the interim goal of EPA's 33/50 Pro- gram a year early. The interim goal of the program was to reduce nationwide releases and transfers of 17 chemicals by 33 percent, or about 486 million pounds, by the end of 1992. According to data reported by facilities to EPA's Toxics Release Inventory (TRI), releases and transfers of the 17 chemicals declined 501 million pounds, from 1.47 billion pounds in 1988 to 973 million pounds in 1991. (The 1991 figures provided here exclude categories of reporting that were not required in 1988.) An analysis of the facilities' pro- jected emissions indicate the 33/50 Program could reach its 1995 goal of a 50 percent reduction of releases and transfers by the end of 1993. EPA began the 33/50 Program to encourage companies to prevent pollution rather than continue to release wastes to the environment or transfer them to waste manage- ment facilities. When companies agree to participate in the 33/50 Program, they provide EPA with a commitment letter detailing their reduction targets. TRI data from 1991 show that more than 200 of the participating companies and individual facilities have met or exceeded their target reductions. Progress reflects many levels of activity EPA views the 33/50 Program as an umbrella under which the fed- eral government, states, industry, and local communities work in partnership to achieve common goals. Any progress in reducing emissions reflects the efforts of all these partners. Many states, a number of industry associations, and numerous indi- vidual companies include 33/50 Program chemicals in their reduc- tion programs. Twenty-six states established toxics use reduction and pollution prevention programs prior to establishment of the 33/50 Program, contributing to its design. Other states have modeled their pollution prevention pro- grams on the 33/50 Program. For more information Call or write the 33/50 Program Coordinators in EPA's ten regional offices. For information about the closest regional office, call the TSCA Hotline at (202)554-1404. Written communications from companies are maintained in a publicly available 33/50 Pro- gram Administrative Record. To view these communications or to obtain other information, call the 33/50 Program at (202) 260-6907 or write to it at the address on page 43. Industry and EPA Find MERIT in Partnership to Prevent Pollution On October 4, 1993, EPA's region- al office in San Francisco announced a new partnership between industry and government to reduce the level of emissions in southwest Los Angeles County. The MERIT Partnership for Pollu- tion Prevention emphasizes multi- media prevention and the mutual goals of economic and environ- mental well-being. MERIT is an acronym for Mutual Efforts to Reduce Industrial Toxics. The ultimate goal of the MERIT partnership is to develop a pollu- tion prevention technology enter- prise zone in southwest Los Ange- les County. This zone would foster innovative methods for reducing releases to the environment. Carl O. Weisinger, of Dow Chemi- cal Company, is co-chairing the MERIT Partnership with Dan Reich, of EPA. About 16 compa- nies, representing a cross-section of manufacturing industries, have joined the partnership, as have rep- resentatives from federal facilities in the area and from state, region- al, and local agencies. CHEMICALS IN PROGRESS ------- I Lead Activities EPA Developing Four Rules on Lead-Based Paint EPA is developing four rules to meet the requirements of the Resi- dential Lead-based Paint Hazard Reduction Act of 1993. A summa- ry of these rules follows. Training, accreditation, and contractor certification In July 1993, EPA submitted to agency review a proposed rule that would: Require that people who engage in lead-based paint activities are properly trained, that training programs are accredited, and that contractors are certified. Set standards for performing lead-abatement activities. Establish a model state program for accrediting and training lead-abatement professionals in accordance with federal standards. Establish a federal program for accrediting and training lead- abatement professionals in states that do not set up their own programs. Provide grants to states to carry out authorized accreditation and training programs. By law, EPA must publish the final rule in the Federal Register by April 28, 1994. identification of dangerous levels of lead EPA is developing a rule to identi- fy lead-based paint hazards, lead- contaminated dust, and lead-cont- aminated soil. To develop lead standards for the rule, EPA is rely- ing on the integrated exposure uptake biokinetic model, which estimates blood lead levels for peo- ple exposed to different environ- mental sources of lead. Final rules for lead-based paint will be published by EPA in 1994. The agency is now documenting the model, using blood lead stud- ies for validation, and is perform- ing independent review of epi- demiological studies. EPA anticipates that the proposed rule will go to EPA's Office Directors' Lead Committee for review in December 1993. The proposed rule would: Identify hazardous conditions for lead-based paintfor instance, paint in deteriorated condition, paint on surfaces accessible to children, or paint that is exposed to friction or high impacts. Develop health-based standards for determining hazardous levels of lead in dust and soil. By law, EPA must publish the final rule in the Federal Register by April 28, 1994. Renovation information In August 1993, EPA submitted to agency review a proposed rule that would require renovators and remodelers to furnish customers with a copy of an EPA brochure about lead hazards before starting work. By law, EPA must publish the final rule in the Federal Register by October 28, 1994. Disclosure of lead-based paint hazards to home-buyers and renters In August 1993, EPA submitted to agency review a proposed rule that would: Require that people selling or leasing housing disclose all known lead-based paint hazards to homebuyers and renters. Require that people selling or leasing housing provide to homebuyers and renters EPA's pamphlet describing lead-based paint hazards. Allow homebuyers 10 days in which to obtain a lead inspection. Require the purchasing contract for a home to contain a warning that the property may contain lead-based paint. By law, EPA must publish the final rule in the Federal Register by October 28, 1994. VOL. 14/NO.3 NOVEMBER 1993 ------- I Lead Activities Lead Legislation Gets Attention on Capitol Hill Congress is expected to consider new lead legislation this session, some of which would expand the requirements of the Residential Lead-based Paint Hazard Reduc- tion Act of 1993. As this article went to print in September 1993, Senator Harry Reid (D-NV), Sena- tor Bill Bradley (D-NJ), and Rep- resentative Ben Cardin (D-MD) had introduced key lead bills. Senate activity Senator Reid's bill (S. 729) requires EPA to promulgate restrictions on the lead content of certain products such as industrial paint and children's toys. S. 729 would also require states to inspect schools and daycare centers for lead hazards, using grant funding to be distributed by EPA. Senator Reid is not new to lead legislation. Over the last few years, he has introduced a number of lead bills. An element common to each of the bills, including S. 729, is an inventory of lead uses that EPA would be required to compile and update periodically. This inventory provision has faced strong opposi- tion from industry. Another ele- ment of Senator Reid's bills in the past was training requirements for those conducting lead-based paint abatement activities. These train- ing provisions were worked into the lead bill that passed last year and are being implemented by EPA. While the schools and day- care provisions are new to the Reid bill this year, Congressmen Henry Waxman (D-CA) and Al Swift (D- WA) included them in lead legis- lation last year. Several committees acted on the legislation, but it never saw action on the House floor. As of September 1993, no lead bills similar to the Reid bill had been introduced in the House. On June 29, the Toxic Substances Research and Development Sub- committee of the Senate Environ- ment and Public Works Committee held a hearing on S. 729- Senator Reid chairs the subcommittee. Victor Kimm, acting assistant administrator for EPA's Office of Prevention, Pesticides and Toxic Substances, testified for EPA. Also testifying were representatives from the National PTA, the Alliance to End Childhood Lead Poisoning, the National School Boards Associa- tion, and the Lead Industries Asso- ciation, among others. Senator Bradley's lead bill was introduced earlier in the summer and has not seen any activity. The bill is very similar to Representa- tive Cardin's bill, which is described in the next section. House activity The lead bill introduced by Repre- sentative Cardin has strong sup- port from the environmental com- munity. Representative Cardin's bill (H.R. 2479) would create a lead-abatement trust fund by levy- ing an excise tax on lead and lead- containing products. The Depart- ment of Housing and Urban Development would allocate mon- ey from the trust fund to public organizations in urban areas to conduct inspections and abate- ments of lead hazards. Representa- tive Cardin introduced a bill with the same concept last year. The Bush Administration, represented by the Department of the Treasury and the Department of the Interi- or, opposed the bill at a hearing in the summer of 1992 before a sub- committee of the House Ways and Means Committee. For more information To obtain more information on activity surrounding these lead bills, call Ruth Heikkinen, of OPPT's Environmental Assistance Division, at (202) 260-1803- Pamphlet on Lead Hazards Being Prepared EPA expects to distribute more than 25 million copies a year of a pamphlet for homeowners and ten- ants about lead risks in housing and how to assess and avoid those risks. The pamphlet is being prepared by EPA, in cooperation with the Department of Housing and Urban Development and the Department of Health and Human Services. The Residential Lead-based Paint Hazard Reduction Act of 1993 directed that the pamphlet be published and distributed. The pamphlet will be ready for distrib- ution in October 1994. CHEMICALS IN PROGRESS ------- Lead Activities OPPT Begins 'Check Our Kids for Lead' Program Employee Program To Serve as Public, Private Model By Joseph J. Breen, Sineta Wooten, and Cindy Stroup Office of Pollution Prevention and Toxics In the Office of Pollution Preven- tion and Toxics (OPPT), we have had many reasons to feel good about our activities to protect children from lead poisoning. These good feelings were bruised a bit, however, when staff members attending a national conference on lead poison- ing in children overheard some comments to this effect: "All these government people ever talk about are their programs and statistics. What does it mean to my sister that 200,000 children are at risk? She wants to know about her boy." When we returned from the confer- ence, these comments prompted us to question how much our col- leagues knew about preventing or reducing their children's exposures to lead. We decided to encourage all OPPT personnel with children under the age of 7which is when children are at increased riskto have them screened for lead poisoning. OPPT management wholeheartedly supported the idea of a Check Our Kids for Lead Program. Check Our Kids for Lead brings a strong personal ele- ment into OPPT's strategy to reduce lead poisoning and serves as a model for business and govern- ment. In developing the program, we were helped by EPA's strong vol- unteer spirit and the special techni- cal talents found in OPPT. The Check Our Kids for Lead work- group obtained support for the pro- gram from EPA's Office of Human Relations and Management, EPA's Office of Safety and Health, and the labor unions. EPA's Safety, Health and Environmental Management Division was already considering a staff educational program on child- hood lead poisoning. The division welcomed the idea of OPPT pilot- ing a lead screening and education program. The primary goals of Check Our Kids for Lead are to educate OPPT staff on lead exposure issues and to encourage OPPT employees to have their children's blood lead levels tested. Once the program is success- fully piloted, we would like to make it available to other offices at EPA headquarters, EPA regional offices, other federal agencies, and the pri- vate sector. Toward that end, we are developing an education program that can be packaged and provided to other groups. Some of the components of Check Our Kids for Lead that we have devel- oped and implemented are described below. A baby card to celebrate the birth of a child in an OPPT family was designed by an OPPT staff mem- ber. The card welcomes the new arrival and includes a copy of the EPA brochure Lead Poisoning and Your Children. The baby card comes in pink or blue. A brochure listing blood lead screening laboratories that service Washington, D.C., and its sur- rounding areas in Maryland and Virginia was produced. An information package about lead poisoning and how to mini- mize exposures was distributed to every OPPT staff member. The package included a cover memo- randum signed by the OPPT deputy director and the presi- dents of the National Federation of Federal Employees, Local 2050, and American Federation of Government Employees, Local 3331. Public outreach activities have included a presentation to Lead- ership Washington, a group of public and private sector execu- tives working to support the Washington, D.C., community; a lead awareness seminar for EPA employees; distribution of the information packages at EPA's Wellness Fair; and participation in the Public and Community Health Program of the Howard University College of Nursing. Discussions have been held with private sector institutes and cor- porations to develop Check Our Kids for Lead programs as part of their employee health care and wellness programs. For more information To obtain OPPT's Check Our Kids for Lead information packet, call Sineta Wooten, of OPPT's Chemical Management Division, at (202) 260-3888 or write to her at the address on page 43. VOL. 14/NO.3 NOVEMBER 1993 ------- Lead Activities Lead Activities at the State Level Are Growing Since Congress passed the Residen- tial Lead-based Paint Hazard Reduction Act in 1992, states have increased their activities to reduce lead exposures. During the 1993 legislative sessions, 12 states intro- duced comprehensive bills relating to reduction of lead hazards. Four of these bills passed, five failed, and three others are pending. Most of the state legislation includes development of certifica- tion programs for lead-abatement professionals. In the Residential Lead-based Paint Hazard Reduc- tion Act, Congress set aside funds for states to use for developing these programs. Before the Residential Lead-based Paint Reduction Act was passed, eight states already had laws aimed at preventing lead poisoning: Cali- fornia, Connecticut, Illinois, Maine, Maryland, Massachusetts, Minnesota, and Rhode Island. Since passage of the act, four states have passed similar laws: Louisiana, Missouri, New Hampshire, and Vermont, Legislation is pending in New Jersey, Ohio, and Wisconsin. The chart on this page identifies the basic elements of each state's lead-hazard reduction laws. State Lead Hazard Reduction Statutes: September 1993 AL AK AZ AR CA CO CT DE FL GA HI ID IL IN IA KS KY LA m Lead screening required Lead poisoning must be reported to state Abatement standards required Training, certification, and accreditation required for abatement professionals Disclosure of lead hazards in real estate transactions required . Public information and education required . . Lead Task Force Required . . I CHEMICALS IN PROGRESS ------- I Lead Activities State Lead Hazard Reduction Statutes: September 1993, cont'd. MD MA MN Ml MS MO MT NE NV NH NJ NM MY NC ND OH OK OR PA Rl SC SD TN TX UT VT VA WA WV Wl WY Lead screening required Lead poisoning must be reported to state Abatement standards required Training, certification, and accreditation required tor abatement professionals Disclosure of lead hazards in real estate transactions required Public information and education required Lead Task Force Required VOL 14/NO.3 NOVEMBER 1993 ------- I Lead Activities / International Activities Lead Update Clearinghouse Provides Technical Information about Lead The U.S. government has a clear- inghouse to provide federal publi- cations, selected journal articles, and other technical information on lead. The clearinghouse is staffed by trained information specialists who can answer specific questions on lead-related issues. The clear- inghouse serves interested citizens; people in the medical, health care, and public health fields; people in the housing construction and resi- dential renovation sectors; people in the retail, financial, real estate, and insurance sectors; the news media; and public agencies at the federal, state, and local levels. The telephone number for the National Lead Information Clear- inghouse is (800) 424-LEAD (424-5323). In the Washington, D.C., metropolitan area, the num- ber for the clearinghouse is (202) 833-1071. Hearing- impaired persons can reach the clearinghouse by calling TDD number (800) 526-5456; the TDD number for the Washington, D.C., area is (202) 293-0113. U.S. Attends OECD Meetings on Chemicals The Organization for Economic Cooperation and Development (OECD) held a series of meetings concerning chemicals the week of May 23, 1993. Representatives from the United States and the 23 other OECD member nations attended the meetings, which took place in Paris. Summaries of the meetings are below. SIDS update The nations that participate in OECD's Screening Information Data Set (SIDS) program agreed to update and expand the list of chemicals for which it is develop- ing test data. Among the chemi- cals that will be considered are those on the European Communi- ty's list of existing chemicals that are produced or imported in excess of 1,000 tons each year. The Euro- pean Community is using the list to identify chemicals of concern. The SIDS program is an effort to develop a base set of test data for existing chemicals produced in the largest quantities worldwide. In 1990, the SIDS program identified for initial action 154 chemicals that are produced in large quanti- ties worldwide. Since then, the SIDS program has worked with industry in its 24 member nations to voluntarily test the chemicals for toxicity potential. Prior to this effort, few test data were available publicly on these substances. EPA's Office of Pollution Preven- tion and Toxics (OPPT) represent- ed the United States at the meet- ing. Also in attendance were repre- sentatives from the European Community, Mexico, the Interna- tional Registry of Potentially Tox- ic Chemicals, and the Business and Industry Advisory Committee. The SIDS prog ram is an effort to develop a base set of test data for existing chemicals produced in the largest quantities worldwide. A meeting was held in September 1993 to determine testing needs for the 58 chemicals in Phase 3 of the SIDS program. In the future, only those chemicals identified as needing discussion will be put on the agenda for SIDS review meet- ings. Other reviews will be con- ducted through written communi- cations. Risk reduction pilot project The risk reduction pilot project is CHEMICALS IN PROGRESS ------- I International Activities exploring how to reduce the risks from exposure to lead, mercury, cadmium, methylene chloride, and brominated flame retardants. Each participating nation is developing a monograph that explains how it regulates each chemical. The monographs will be analyzed to identify risk reduction activities for the nations to act on, either individually or collectively. Lead is the first chemical to under- go this process. The monograph was recently completed and mem- ber nations are developing collec- tive activities for implementation. These activities will be incorporat- ed into the OECD Council Lead Act. Drafting of the act will begin in November 1993. Harmonization The OECD renewed the mandate for the Good Laboratory Practice Panel and endorsed a document clarifying procedures for develop- ing test guidelines that meet OECD harmonization standards. The United States and European Community nations are analyzing how each nation's industry will be affected economically by harmo- nization of health effects classifica- tions. The OECD's long-term plans include harmonizing the classification of reproductive effects and carcinogenicity. New chemicals assessments The United States and Canada are conducting a pilot study on the feasibility of exchanging new chemicals assessments. The Aus- tralian delegation reported on the results of a survey they conducted on new chemicals assessment pro- grams. The study shows that nations agree on the need for increased exchange of assessments and notes existing barriers may prevent more sharing. Intergovernmental forum on chemical safety The Swedish delegation hosted an informal meeting to prepare for the first session of the Intergovern- mental Forum on Chemical Safety, scheduled for April 1994. The forum will oversee implementation of the toxic chemicals program areas identified in UNCED Agen- da 21, chapter 19. The program areas are risk assessment, risk reduction, information exchange, strengthening national capabilities for managing chemicals, and stan- dardizing the way chemicals are classified and labeled. At the meeting, the United States emphasized the need to move toward organizing risk-reduction activities around specific process or use patterns rather than on a chemical-by-chemical basis. This approach would allow risk compar- isons, which helps assessors to identify safer products and process- es that can prevent pollution. The United States also advocated that developing countries build their capacity for chemicals manage- ment by first implementing low- cost, high-benefit programs and moving to more sophisticated pro- grams as resources permit. Nations' Biotechnology Regulations Are Surveyed In a survey of its member nations, the Organization for Economic Cooperation and Development found many similarities among the nations' biotechnology regulations. The results of the survey were reported in the Workshop on the Environmental Aspects of Biotech- nology held in Brussels on May 3 and 4, 1993. A second workshop is scheduled for May 1994. OECD Forms International Pesticide Forum In June 1993, the OECD estab- lished a forum to support efforts to harmonize requirements for pesti- cide licensing programs. The new Environment Pesticide Forum will work on test guidelines, data requirements, hazard/risk assess- ment, re-registration, information exchange, risk reduction, and har- monization of classification sys- tems. Forum members agreed that whenever its work overlapped with work being done by OECD's ongo- ing chemical program, the two programs would integrate their efforts. Two areas in which this is likely to occur are development of test guidelines and harmonization of classification systems. m VOL 14/NO.3 NOVEMBER 1993 ------- I Biotechnology EPA and Environment Canada Address Bioremediation Risk Assessment A workshop on risk assessment issues related to use of bioremedia- tion to clean up hazardous waste sites in the United States and Canada was held June 17 to June 18 in Duluth, Minnesota. The workshop was attended by about 90 people, representing universi- ties, industries, federal organiza- tions, and state and provincial gov- ernments in both nations. The workshop targeted 10 groups of biodegradable wastes commonly found at U.S. and Canadian sites, including trichlorethylene (TCE), polychlorinated biphenyls (PCBs), and munitions. It was sponsored by Environment Canada's Com- mercial Chemicals Branch and two EPA officesthe Office of Pollu- tion Prevention and Toxics (OPPT) and the Office of Research and Development (ORD). At the workshop, a private firm, Southern Bioproducts, gave a detailed presentation on its pro- posal to test the TCE-degrading capabilities of a strain of Pseudomonas cepacia at a Canadi- an site. The test would involve the first North American release of a recombinant bacterium for on-site cleanup. The U.S. Department of Defense's laboratory at Fort Det- rick, Maryland, also gave a presen- tation on a set of biological assays for toxicity screening of remedia- tion site effluents. Workshop participants received a detailed issue paper, prepared by the University of Tennessee and EPA, summarizing the available literature in five areas: risk assessment schemes major metabolic pathways of selected hazardous pollutants human health protocols for metabolite and pathogenicity tests ecological effects protocols for metabolite and pathogenicity tests fate protocols and issues for microorganisms and metabolites The workgroups' key findings and recommendations in these areas will be considered by EPA and Environ- ment Canada as they continue to develop guidance for bioremedia- tion product evaluations. Summary of key findings Risk assessment schemes. The risk assessment workgroup developed a general flow diagram for health and environmental risk assessment relevant to bioremediation sites. Information on microorganisms, site pollutants and their physical and chemical properties, and gen- eral site characteristics were identi- fied as necessary components of a risk assessment. Participants rec- ommended that laboratory and/or greenhouse efficacy studies (such as mass balance or other microcosm tests) and information on metabol- ic pathways also could be useful for identifying metabolites and assess- ing metabolite toxicity. Metabolic pathways. The goal of this workgroup was to determine the combinations of pollutants, path- ways, and environmental factors that lead to generation of signifi- cant quantities of hazardous metabolites. The group concluded that the intermediates for some compounds (such as aromatics) and specific organisms are predictable given certain site information. Often, however, the presence of complex mixtures complicates the process. For metabolites of known structure, quantitative structure- activity analysis techniques can be useful in predicting toxicity. The workgroup discussed specific metabolites of concern for metals, aromatic hydrocarbons, phenolics, halogenated organic compounds, alkanes, pesticides, sulfur- and nitrogen-containing heterocyclics, complex mixtures, and munitions. Human health protocols. This work- group determined that metabolite toxicity should be tested separately from pathogenicity and toxin pro- duction. Participants acknowl- edged that reliable tests already exist for assessing metabolite toxi- city but that techniques for extrac- tion of chemicals sorbed to sedi- ments need further development. Exposure routes for microorgan- isms depend on the specific biore- mediation process, but pathogenic- ity tests might need to consider oral, intravenous or intraperi- toneal, and pulmonary exposures CHEMICALS IN PROGRESS ------- Biotechnology when the microorganism is unknown. When some information is available, rapid screening tests, such as gene probes, are needed. The group also recommended fur- ther research on the allergenicity effects of microbial antigens, and their effects when combined with chemicals at a site. The group also developed a decision tree for tiered mammalian health effects. Ecological effects. Like the human health workgroup, the ecological effects workgroup also concluded that metabolite toxicity and path- ogenicity should be addressed using separate tests, with patho- genicity tests dependent on the availability taxonomic informa- tion. The decision tree developed by the workgroup began with tests for pathogenicity, followed by single species tests with both positive and negative controls. For pathogenicity testing, the work- group recommended using, for aquatic vertebrates and mammals, EPA Pesticides Program's Subdi- vision M tests and, for plants, in vitro screening tests, such as enzyme tests. For toxicity testing, the group concluded that protocols such as EPA's Office of Water's short-term chronic tests would be appropriate, but that tests for terrestrial organ- isms might need refinement. The decision tree also included the selection of toxicity tests based on exposure and ecosystem tests, where applicable. Fate protocols and issues. This work- group felt that the microcosms currently used for efficacy studies are simplistic relative to field con- ditions. Participants recommended the following test endpoints for risk assessments: mass balance for parent compounds, accumulated metabolites, and gaseous end prod- ucts; persistence; and residual den- sity of organisms mediating the bioremediation process. The work- group also identified site informa- tion critical to determinations of chemical and microbial fate and transport. The workgroup exam- ined the applicability of some mathematical models to determin- ing metabolite and bacterial/fun- gal fate and transport in the sub- surface, and found them inadequate for risk assessment. Items recommended for inclusion in risk assessment models were microorganism growth and death rates, dissemination and transport, persistence of boundary values such as lower survival levels of degradative organisms, sensitivity analysis, potential for formation and exposure, contaminant strate- gy under site conditions, potential for genetic exchange, predation rate quantitation, and net metabo- lite formation and decay. For more information Workshop findings will be detailed in an ORD report that will be available in early 1994. For more information, call Philip Sayre, OPPT's Health and Envi- ronmental Review Division, tele- phone, (202) 260-9570, or write to him at the address on page 43. Or, call Terry Mclntyre, of Environment Canada, at (819)953-6684. Biotechnology Workshop Scheduled for January A workshop to develop ecological tier testing schemes for micro- organisms used in biotechnology applications will be held January 11 through 13, 1993, in Washington, D.C. The applications on which the workshop will focus are bioremedi- ation, biomining, mineral leach- ing, coal transformations, desulfur- ization of petroleum products, oil recovery, biomass conversion, fuel production, waste treatment, nitrogen fixation, and closed sys- tem fermentation. Key findings and recommendations from the workshop will be consid- ered by EPA and Environment Canada as the agencies develop guidance for using microorganisms in these applications for the United States and Canada, respectively. The workshop is jointly sponsored by EPA's Office of Pollution Pre- vention and Toxics, EPA's Office of Research and Development, and the Commercial Chemicals Branch of Environment Canada. For information about attending the workshop To arrange to attend the confer- ence, call Lou Borghi, telephone, (703) 934-3255 or Jennifer Wei- ham, telephone, (703) 218-2639, at Clement International Corporation. VOL. 14/NO.3 NOVEMBER 1993 ------- Enforcement/General Information Roundup: Enforcement Activity In a brief supporting its petition for review before the U.S. Court of Appeals for the District of Columbia Circuit, the Minneso- ta Mining and Manufacturing (3M) Company argued that the federal five-year statute of limi- tations should apply to assess- ment of civil penalties under the Toxic Substances Control Act (TSCA). Last year, EPA's Envi- ronmental Appeals Board upheld a 1988 administrative law judge's decision against the 3M Company for importing chemicals not on the TSCA Inventory and for incorrect import certification between 1980 and 1986. The 3M Com- pany is headquartered in Min- neapolis, Minnesota. Hall-Kimbrell Environmental Services and EPA have signed consent agreements to settle cas- es brought by four EPA regional offices. The cases resolved the issue of whether dry wall and hard plaster are suspect materi- als under the Asbestos Hazard Emergency Response Act (AHERA). Under the consent agreements in EPA regions 2, 7, 8, and 9, Hall-Kimbrell, an asbestos contractor, will pay penalties amounting to $285,000. In EPA regions 7 and 8, Hall-Kimbrell will also send to every school district for which it prepared an asbestos management plan a letter stat- ing that EPA instructs the dis- trict to assume that any drywall and hard plaster in schools con- tain asbestos. EPA acknowl- edged in the agreements for regions 2 and 7 that Hall-Kim- brell had voluntarily re-per- formed $5 million of work in schools. Hall-Kimbrell is based in Lawrence, Kansas. EPA's region 2 office is in New York, New York; the region 7 office is in Kansas City, Kansas; the region 8 office is in Denver, Col- orado; and the region 9 office is in San Francisco. EPA and the Ciba-Geigy Com- pany have entered into a consent agreement that requires Ciba- Geigy to pay a civil penalty of $62,000 and to perform an audit to ensure compliance with EPA regulations. Penalties stip- ulated as a result of this volun- tary audit cannot exceed $1 mil- lion. EPA filed suit against Ciba-Geigy and 21 other com- panies for failing to submit pre- manufacture notices (PMNs) before manufacturing or importing new chemical sub- stances, as required by section 5 of the Toxic Substances Control Act (TSCA). The Ciba-Geigy case was the first of these cases to be settled. Schools Awarded $76.2 Million for Asbestos Abatement EPA has awarded $76.2 million in grants and loans to schools for use in abating asbestos. The funds were offered to public school districts and private nonprofit schools for abatement projects in 239 schools. More than 400 local education agencies had applied for the funds. The awards consist of about $5.7 million in grants and $70.5 mil- lion in interest-free loans. They constitute the largest appropria- tion in the history of EPA's asbestos abatement program, established by the Asbestos School Hazard Abatement Act (ASHAA). The schools that were offered awards met two conditions: They demonstrated financial need, and they contained asbestos posing a high degree of hazard. ASHAA directs EPA to rank each school's proposed projects according to the type of asbestos-containing build- ing materials in the school and the materials' condition. Since 1985, EPA has provided $422 million to 2,377 schools for asbestos abatement. EPA estimates these abatement projects, once completed, will eliminate 28 mil- lion exposure hours per week. Public school districts and private nonprofit schools will be notified if Congress appropriates funds for awards in fiscal 1994. ffl CHEMICALS IN PROGRESS ------- I Biotechnology Availability of 8(e) Notices and FYI Submissions Under section 8(e) of the Toxic Substances Control Act (TSCA), anyone who obtains information that indicates a chemical may pose a substantial risk of injury to human health or to the environ- ment must report that information to EPA within 15 working days of obtaining it. From October 1, 1991, to August 27, 1993, more than 7,900 TSCA section 8(e) notices were submitted to EPA's Office of Pollution Pre- vention and Toxics (OPPT). The majority of these were submitted by companies participating in EPA's Compliance Audit Program (CAP), which provides reduced penalties for companies submit- ting late studies. FYI submissions EPA received 10 For Your Infor- mation (FYI) submissions from April 1, 1993, to August 31, 1993. FYIs are voluntary submis- sions and may include data on chemical toxicity and exposure, epidemiology, monitoring, and environmental fate. How to obtain 8(e) notices and FYI submissions Section 8(e) and FYI submis- sions can be reviewed and photocopied at EPA headquar- ters, in the TSCA Non-Confi- dential Information Center, telephone (202) 260-7099 or (202) 260-0660. A copy of a full section 8(e) or FYI submission can be obtained by writing to Freedom of Infor- mation Office (A101), U.S. EPA, 401 M Street, S.W., Washington, D.C. 20460. Duplication of the first 166 pages of any document is free. At the 167th page, there is a $25 fee and an additional $0.15 charge for each page. Chronological indices of section 8(e) and FYI notices are avail- able from the TSCA Hotline two to three months after the end of each fiscal quarter. The fiscal quarters end on September 30, December 31, March 31, and June 30. Information on contacting the hotline is on page 43. Overview of TSCA Section 8(e) Notices October 1,1991 to August 27,1993 Total number received 7,965 Number entering initial screening Number completing initial screening Hazard concern Low Medium High Number on TSCA Inventory* 5,958 4,984 1,358 1,863 1,763 2,818 * Once a CAP submission enters initial screening, OPPT determines whether the chemical substance is listed on the TSCA Inventory. Thus, the numbers in this col- umn do not include submissions that have not entered screening. New Databases Available to the Public The Office of Pollution Prevention and Toxics is making available the Toxic Substances Control Act (TSCA) section 8(e) database and the TSCA section 4 abstracts database. Section 8(e) of TSCA requires manufacturers, importers, and distributors of chemical substances and mixtures to inform EPA of risk of injury to human health or the environment. The TSCA section 8(e) database con- tains the ranking system that EPA uses to prioritize section 8(e) submis- sions by toxicity concern. Section 4 of TSCA requires industry to submit to EPA unpublished test- ing data on the health and environmental effects of specific chemicals. This database contains abstracted summaries of the full studies submitted under section 4. Both databases can be used as pointer systems to access full studies of interest to users. For copies of the databases, please call the TSCA Hot- line at (202) 554-1404. D VOL 14/NO.3 NOVEMBER 1993 ------- TSCA Hotline/IRIS TSCA Hotline: Question & Answer Q: What are my responsibilities for providing updates to the TSCA inventory data base? A: The Toxic Substances Control Act (TSCA) Chemical Substances Inventory is a comprehensive list of chemical substances that can legally be manufactured in the United States or imported. Every four years, EPA requires companies to report certain information to update the TSCA inventory. You will be required to report in 1994 if you import or manufacture 10,000 pounds or more of a reportable substance at any single site during the last fiscal year com- pleted prior to the reporting peri- od. The reporting period begins August 25, 1994, and runs to December 23, 1994. All substances on the TSCA inven- tory are subject to the rule's reporting requirements, with the exception of polymers, inorganic substances, microorganisms, and naturally occurring substances. Substances in these excluded cate- gories are reportable, however, if they are subject to proposed or final rules under sections 4, 5(b), 5(e), 6 of TSCA, or if they are the subject of relief granted under a civil action under sections 5 or 7 of TSCA. Exemptions from reporting Exempted from reporting are cer- tain small businesses and those that manufacture or import under limited circumstances (such as, nonisolated intermediates or small quantities of a substance for research and development). Also exempted from reporting is anyone who has already submitted the information required for the inventory update to EPA under section 8(a) of TSCA. To qualify for this exemption during the next reporting period, the information would have to be submitted on or after August 25, 1993. To submit information for the update Information for the update must be reported on an original copy of Form U or by magnetic media. Complete instructions for com- pleting the reporting form or preparing a magnetic media report are in the booklet Instructions for Reporting for the Partial Updating of the TSCA Chemical Inventory Data Base. Reporting forms and the instruc- tion booklet for the 1994 report- ing year will be available from the TSCA Hotline; telephone, (202) 554-1404. Anyone who reported for the last reporting period will automatically be mailed reporting materials. Late reporting. The last reporting period began August 23, 1990, and was extended to February 21, 1991. If you were required to sub- mit information for that period and did not do so, call Scott Sherlock, of OPPT's Information Management Division, at (202) 260-1536. For more information For more information about the Partial Updating of the TSCA Chemical Inventory Data Base, see 40 CFR 710.25 to 710.39. IRIS Is Accessible to the Public The Integrated Risk Information System (IRIS) is an EPA database containing health effects informa- tion and regulatory information on about 400 chemical sustances. The database is accessible to the public through the National Library of Medicine's Toxicology Data Net- work. Disketttes containing the database can be purchased from National Technical Information Service (NTIS) (order number PB91-591331). For more informa- tion, call the National Library of Medicine at (301) 496-6531; the NTIS at (703) 487-4650; or IRIS User Support at (513) 569-7254. CHEMICALS IN PROGRESS ------- I For More Information Send All Correspondence to Environmental Assistance Division (7408) Office of Pollution Prevention and Toxics U.S. EPA 401M Street, S.W. Washington, D.C, 20460 Would You Like to Receive the Chemicals-in-Progress Bulletin? The Chemicals-in-Progress Bulletin is published by EPA's Office of Pol- lution Prevention and Toxics. If you are not currently receiving the Bulletin and would like to become a subscriber, or if you would like to stop receiving the Bulletin, please fill out this form or tape a mail- ing label onto it, and mail it to the address on this page. D Please add my name to the mailing list. D Please change my address. D Please take my name off the mailing list. D Please send me the following publication(s): Name Title Company or Organization Name Type of Business Street Address City State Zip Code TSCA Hotline: Call (202) 554-1404 The TSCA Hotline operates Mon- day through Friday, from 8:30 a.m. to 5 p.m., Eastern time. To speak to an information specialist, call (202) 554-1404. FAX requests for documents are received every day, at all times, on (202) 554- 5603. Documents can also be requested by deaf persons who have TDD equipment by calling (202)554-0551. To request assistance by mail, write to the Environmental Assis- tance Division at the address at the left. Lead Hotline: Call (800) LEAD-FYI Parents can obtain information about protecting their children from lead poisoning by calling the National Lead Information Center Hotline at (800) LEAD-FYI (532- 3394), The hotline operates 24 hours a day, seven days a week, in English and in Spanish. The line is answered by a record- ing that asks callers to leave their name and address. Callers are then sent information on reducing chil- dren's exposure to lead, testing a home for lead, getting blood-lead levels tested, and the possible lead hazards generated by home repairs and renovations. A list of state and local agencies that can provide additional information is also included. Materials are available in English or Spanish. VOL. 14/NO.3 NOVEMBER 1993 ------- |