United States January 1984 Environmental Protection Agency Washington DC 20460 &EPA Toxic Substances Control Act (TSCA) Report to Congress for Fiscal Year 1983 ------- Toxic Substances Control Act (TSCA) Report to Congress for Fiscal Year 1983 Prepared by: U. S. Environmental Protection Agency Washington, DC 20460 January, 1984 ------- Contents 1 Introduction : 1 2 Highlights of the Year Program Implementation 3 International Activities 5 Regulatory Improvement 6 Enforcement 7 3 New Chemicals Program Status 9 PMN Rule 10 Exemptions 11 Follow-Up program 11 4 Existing Chemicals Program Status 13 Existing Chemicals Control 15 Information Activities 18 5 Chemical Testing Program Status 21 Test Guidelines 22 Reimbursement of Testing Costs 22 Quality of Data 23 6 Enforcement 24 7 Litigation 27 8 State Programs 32 Tables 1. Summary of New Chemical Actions 2. Summary of Existing Chemical Actions 2A. Detail Summary on National Toxicology Program Studies and CHIPs 3. EPA Response to Interagency Testing Committee (ITC) 4. Administrative Civil Actions Taken Under Section 16 of TSCA 5. TSCA Section 28 Appendices. Appendix A - Summary/Guide to Information Required by Congress (Section 9(d), 28(c) and 30) Appendix B - Major FY'83 TSCA Actions ------- 1 Introduction This sixth annual report to Congress summarizes progress made by the Environmental Protection Agency (EPA) in implementing the Toxic Substances Control Act (TSCA) during Fiscal Year 1983. This report fulfills the Congressional reporting requirements of sections 9(d), 28(c) and 30, in addition to providing highlights of significant environmental programs and Agency progress in achieving environmental quality. The Toxic Substances Control Act (TSCA) took effect on January 1, 1977. Since that time, the Office of Toxic Substances (OTS) under the direction of the Assistant Administrator for the Office of Pesticides and Toxic Substances (OPTS) has had the responsibility for developing and implementing the statutory requirements of the Act as well as the discretionary authorities included by the Congress to enhance its effectiveness. TSCA is a complex piece of legislation with a scope comprehensive enough to encompass the many gaps in the eighteen existing public health and environmental laws. Through TSCA, the EPA seeks to prevent or reduce the chance of injury to the public and the environment from harmful chemicals. TSCA provides EPA with the authority to evaluate and regulate if necessary at any stage in a chemical's life cycle including manufacture, process, commercial distribution, use and disposal. Programs now exist under the Act to evaluate chemicals prior to commercialization through a process of premanufacture notification for new chemicals and new uses of existing chemicals (Section 5); to evaluate existing chemicals (after commercialization) by requiring testing under Section 4 and reporting of additional data under Section 8; and to control unreasonable risks of existing chemicals through regulatory action under Sections 6 and 7. While TSCA authorizes many regulatory approaches in response to harmful chemicals, it is wholly consistent with the concept of adequately controlling problems while ------- imposing minimal burdens (Executive Order 12291, the Regulatory Flexibility Act, and the Paperwork Reduction Act). Specifically, TSCA mandates that its authorities not impede or create unnecessary economic barriers to technological innovation and that EPA use reason and prudence in carrying out its responsibilities. To achieve a balanced regulatory approach, the Act requires a weighing of risks against the benefits provided by particular chemicals or classes of chemicals. ------- 2 Highlights of the Year Program Fiscal Year 1983 saw significant achievements in all areas Implements- °f TSCA implementation. While the Agency met all tion statutory requirements of the Toxic Substances Control Act and all court ordered deadlines, a major accomplishment in itself, it also focused on developing and implementing discretionary, yet critical, sections of the Act. This was the first year in which the Agency saw the results of its negotiated testing program under Section 4 of TSCA. This program, initiated in 1980, sought to minimize the time and resources needed to develop test data for chemicals identified as having potential adverse effects. EPA, working with the affected manufacturers and industry consortia, developed a negotiating process to abbreviate the formal rulemaking process of Section 4. While the integrity of the data and its development is maintained, the time of development is shortened substantially, providing data more rapidly for,risk evaluation. These negotiated testing agreements (NTAs) are made in lieu of formal testing rules whenever agreement can be reached. In FY'83, the Agency received nearly 200 test studies performed on chemicals subject to past testing actions under these Negotiated Testing Agreements. These incoming data are a key component in the risk identification activities carried out under TSCA's existing chemicals program and would not yet be available save for the negotiated process. FY'83 was also a year of major changes in the Agency's approach to existing chemical control. In FY'83, an OTS Existing Chemicals Task Force developed and put into place a project management system for evaluation and decisionmaking on risks from existing chemicals. During the year more than 60 chemicals were brought under evaluation, selected on the basis of Section 8(e) notices, Section 4 test results, and NTP test results. ------- Nearly half of these 60 were identified for further analysis over the next year and five were chosen as candidates for possible regulatory action. With the exception of the promulgation of the PCB rules, which are specifically mandated by Section 6(e) of TSCA, this represents more actions than taken in all previous years since TSCA was enacted. On August 22, 1983, the Agency promulgated the final Section 8(c) rule requiring manufacturers and processors to maintain records of alleged significant adverse reactions to health or the environment. When a chemical worker, consumer or a resident living nearby a plant alleges an adverse reaction to a chemical, mixture, process article or plant effluent, this rule establishes the mechanism for the retention of such allegations. Worker health allegations must be retained for 30 years and all others for five years. The Agency will inspect and require reporting of such records. This rule will help the Agency identify previously unknown chemical hazards as well as to reveal patterns of effects that might otherwise go unnoticed for long periods of time. In May 1983, a final premanufacture notice (PMN) rule was issued. The effective date of the rule was October 1983. Prior to this time, the PMN process was conducted under an interim policy with proposed rules. The final PMN rule establishes standardized PMN reporting and recordkeeping requirements and provides consistent requirements for new chemical review. The important benefits of the rule include 1) a standardized reporting form and 2) the ability to declare individual PMN submissions incomplete. As a result EPA is able to address more effectively the increasing number of PMNs it receives. In 1983 EPA developed more Section 5(e) orders than in all other years to date. These orders are aggressive responses by EPA to the PMN submitter that additional data must be submitted or developed prior to commercialization. "Consent 5(e) order", a new approach to the problem of insufficient data submission, is an agreement between EPA and the submitter to allow commercialization with tight controls until data are developed, thereby encouraging innovation while ensuring protection of the public health and the environment. In FY'83 EPA issued the first proposed significant new use rules (SNUR); three for new chemicals and one for an existing chemical. The SNUR authority of TSCA (Section 5(a)(2)) provides the Agency with the ability to require additional review and evaluation of a chemical for which production, use or exposure patterns have changed significantly. Before introducing a designated changed use ------- pattern, the SNUR would require the manufacturer to submit additional data and information to allow he Agency to re-evaluate the potential risks associated with the chemical. The implementation of this authority is a critical step towards continuing chemical control after commercialization. These highlights present an overview of major TSCA implementation steps. Many additional activities within EPA, and the Office of Toxic Substances, will be presented in more detail in specific programmatic sections of this report. International Since the passage of TSCA, EPA has actively participated Activities 'n a ran9e °f international programs centered on toxic - substances control. EPA participation in these programs is critical as toxic substance issues often transcend national bouhdaries. International chemical regulation can affect international trade and the economic stability of various chemical industries. Exchange of data and assessment techniques can offer significant benefits to all nations. EPA contributes strongly to the success of these programs through the sharing of its technical expertise and its broad experience in chemical review and control. EPA's participation also enhances the effectiveness of its own operations and its role in chemical control in the United States. Perhaps the most visible and successful of EPA's international efforts continues to be its participation in the Chemicals Program of the Organization for Economic Cooperation and Development (OECD), an international group composed of the major industrial trading nations. Because national laws regulating hazardous chemicals can create barriers to international trade in chemicals, the OECD began a program in 1977 to harmonize its member countries' programs regarding toxic substances control. The OECD Chemicals Program focuses primarily on the elimination or reduction of barriers to international trade in chemicals and on the sharing of technical expertise. During 1983 EPA participated actively in the OECD test guidelines development program. EPA has the lead for developing four new OECD test guidelines as well as participating in the OECD Test Guideline Update Panel and expert workgroups. The development of additional OECD test guidelines will improve the quality of data developed worldwide and will reduce the need for unnessary, duplicative testing. Also, FY'83 was the first year of a new international initiative in existing chemicals. This existing chemical initiative focuses on identifying and harmonizing the needs of member countries with respect ------- to chemical testing. As part of this activity, EPA chairs the Switchboard Project, a referral system which will improve access by member countries to unpublished information. In addition, EPA experts made significant contributions to the development of a common format for existing chemical reviews. This common format will facilitate the exchange of information and the development of methods for identifying chemicals on which data are currently inadequate. The U.S. has also developed a notification program under Section 12 of TSCA, which provides for notification to foreign countries regarding the hazards associated with chemicals regulated under TSCA. Also, EPA participates in several United Nations' programs, such as the International Register of Potentially Toxic Chemicals (IRPTC) of the U.N. Environmental Program (UNEP). The basic objective of IRPTC is to promote more efficient use of national and international resources in the evaluation and control of chemical risks. EPA supports the IRPTC by notifying the program of chemical incidents, completed preliminary risk assessments and proposed regulatory actions and by responding to foreign inquiries relayed through IRPTC. EPA also participates in another UNEP project to develop a Global Ozone Protection Convention. Once adopted, this convention will provide for better coordination and greater cooperation among nations in regulation, research, monitoring, and information exchange concerning stratospheric pollution and potential modification of the ozone layer. EPA is also active with the U.N. World Meteorological Organization and the Chemical Manufacturers Association (CMA) Fluorocarbon Program Panel in a joint international effort to improve global monitoring of the earth's ozone layer. Additionally, EPA has a working agreement with the Federal Republic of Germany to exchange technical information in the area of exposure modeling. Regulatory The major focus of OTS' activities in pursuing regulatory Improvement improvements has been to maximize public input into its decisionmaking in order to minimize the burden of regulation wherever appropriate. EPA is continuing to develop ways to ensure public health and environmental protection while minimizing the adverse impact on innovation and the economic costs of regulatory controls. This is accomplished through such activities as negotiated rulemaking, development of Agency wide strategies for chemical control and public outreach activities. ------- In addition to the negotiated testing agreements mentioned earlier, EPA is actively developing plans for negotiated rulemaking. A negotiated process such as the negotiated testing agreements has enabled the Agency to develop regulations more rapidly, achieving greater public input in the beginning and less adversarial conflict during the process. A recent project demonstrates the benefits of this approach. The most recent PCB regulations were negotiated between the affected industry and two environmental groups. This proposal was submitted to the Agency and will provide the core of final rulemaking. In addition, toluenediamine (TDA), a chemical under assessment for TSCA rulemaking, has been identified by the Agency as another candidate for negotiation under this new program. The Agency is also working toward coordinating i strategies for chemical control with all EPA programs. While TSCA enables EPA to utilize various control options, the Agency is encouraging intra-office input into risk assessment activities and risk management alternatives. The evaluation of hexachlorobenzene (HCB) is a good example of this comprehensive approach. EPA has found that effective public outreach and education programs have often helped minimize the adverse impact of Agency regulations. Providing accurate and timely information to the public and industry allows for a better understanding of the rule or regulation and encourages compliance. Toward this end, OTS has created a task force to develop an education program for those affected by the Section 8(c) rule. OTS is also currently developing a strong program to interact with the Regions and States on information sharing on chemicals of mutual concern. EPA has held two well-attended public meetings to explain the final PMN reporting rule and the final Section 8(c) rule. Each of these meetings were attended by over 200 people. Enforcement Under Section 16 of TSCA, EPA may levy either civil or criminal penalties for a violation of certain sections of the Act. In FY'83, most of the civil enforcement actions under Section 16 involved alleged violations of the PCB rules. The Agency filed a total of 285 civil complaints during the fiscal year as a result of PCB inspections. Also in FY'83, the Agency took its first dioxin enforcement action under TSCA concerning disposal requirements. In FY'83, the Justice Department, on behalf of EPA, obtained a criminal conviction for illegal interstate transportation of PCBs and 7 ------- PCB containers and for improper disposal of PCB material. FY'83 also saw the first imposition of major fines for PMN violations. In addition, the Agency initiated inspection programs to monitor compliance with Negotiated Testing Agreements, and inspections continued under the Section 6 asbestos-in-schools rule. 8 ------- 3 New Chemicals Program In Section 5 of TSCA, Congress instructed EPA to review Status new chemicals. New chemicals are those which do not appear on the Agency's inventory of existing chemicals. Under Section 5(a), manufacturers must notify the Agency of their intent to manufacture or process a new chemical through the PMN process. EPA has devoted significant resources in FY'83 to refining the PMN review process; to developing appropriate analytical tools for review of new chemicals, to executing the reviews and, where appropriate, making the decision to regulate new chemicals. Section 5(e) of TSCA authorizes EPA to propose an order to regulate a new chemical, pending the development of information that is needed to make a reasoned evaluation of its health and environmental effects. This authority is used if additional data are needed to evaluate whether a chemical may present an unreasonable risk or may result in significant or substantial environmental release or human exposure. Section 5(f) authorizes EPA to issue rules, or orders controlling the manufacture, processing, or distribution of individual new chemicals in commerce that present or will present unreasonable risks. EPA identified two potential Section 5(f) actions in FY'83. In both cases the submitting company voluntarily withdrew the PMN. Regulations written pursuant to Section 5 also require a manufacturer to provide a Notice of Commencement of Manufacture after EPA review of the PMN is completed. This notice is given when the manufacturer is actually ready to begin producing the substance. It is at this point that a new chemical is added to the EPA inventory of existing chemicals. With its experience in new chemical review and regulation, EPA can now act more quickly to identify potential problems or gaps in data. This is partly due to the refinement of the PMN program but also reflects a general improvement in the quality and quantity of data ------- 10 being generated by submitters. With EPA's programmatic refinements and improved quality of data available to EPA decision-makers, the PMN program has evolved to a sophisticated problem identification and control tool. (See Table 1). For example, since the beginning of the program in 1979 through September, 1983, EPA has received 3012 PMNs; issued 14 Section 5(e) orders banning or controlling exposure to 27 chemicals, pending the development of additional data — 10 of these orders, covering 16 chemicals (one of these 16 represents 106 Synfuel PMNs), were issued this year. In one major action under the PMN program, EPA reviewed a notice submitted by Union Oil Company on a wide range of new synthetic fuels to be derived from oil shale in the nation's first commercial shale oil project. Union Oil Company provided extensive information on its products in the notice, including interim data on long-term toxicity tests. After extended negotiations, EPA and Union entered into a Section 5(e) consent agreement that required controls on workplace exposure and environmental release, and limiting the overall production of shale oil until the long-term tests were completed and the results reviewed. In addition to those Section 5(e) actions which EPA issued, 20 PMNs were withdrawn by their submitters in anticipation of EPA action under 5(e). PMN Until recently the PMN process was conducted under an Rule interim policy with proposed rules. The final PMN rule, together with a mandatory notice form, was issued on May 13, 1983 (48 FR 21722). In response to petitions received in June, 1983 from the Chemical Manufacturers' Association (CMA) and the Society of the Plastics Industry (SPI), EPA postponed the effective date of the PMN rule to allow clarification of specific rule provisions. On September 13, 1983 a Federal Register Notice (48 FR 41132) was published which announced that the major provisions of the PMN rule would go into effect on October 26, 1983. These requirements will promote standardized PMN reporting and recordkeeping procedures. They will allow EPA to more effectively address the increasing number of PMNs it is now receiving and will ensure consistent enforcement of Section 5 provisions. Three provisions regarding exemptions for research and development activities, the definition of "possession or control," and data requirements on related chemicals have been stayed pending further review. EPA's interim policy will continue to govern these questions until final provisions have been developed. ------- Exemptions The statutory determination for exempting chemicals from the PMN process requires an Agency finding that such chemicals will not present an unreasonable risk (Section 5(h)(4)). EPA has found that for many new chemicals its review can be completed in the first three weeks of the 90 day period. EPA has, therefore, identified certain chemicals and categories of chemicals that can be exempted from full PMN review and has proposed rules to exempt those chemicals. The intent of these proposed rules is to allow companies to manufacture low risk chemicals more promptly and to allow EPA to devote more time and resources to detailed reviews and follow-up actions for other chemicals .which raise serious concerns. These broad exemption categories include site limited intermediates (chemicals that react to form other chemicals at their site of manufacture), chemicals that are produced in small amounts (i.e., less than 10,000 kg./yr.), and certain polymers. These rules were proposed in August 1982 and resulted in many public comments. These comments covered the entire spectrum of concern from industry fears that the burdens associated with complying with the exemption were too great to the public's concern that the exemptions compromised'the safeguards imposed by the PMN process. After evaluating these comments, EPA developed final rules, which are currently undergoing final review. Under Section 5(h)(1) of TSCA, EPA can grant exemptions to full PMN review for substances produced for test market purposes if the substance does not present an unreasonable risk to human health and the environment under test marketing conditions. In FY'83 EPA acted on 81 test market exemption applications, of which 74 were granted, 2 denied and 5 were withdrawn in anticipation of EPA denial. EPA's review of test market exemption requests places the burden for establishing no unreasonable risk findings on the manufacturer. If there is insufficient data to make this finding the application is denied. Follow-up Program An additional element of the PMN review program is a strategy to track new chemicals that might be of concern if their uses change or production volumes increase after their initial PMN review. EPA employs two major follow-up tools to ensure the re-evaluation of any PMN chemical that has the potential to present an unreasonable risk under new conditions of use. 11 ------- First, the Section 5(a) significant new use (SNUR) provisions allow EPA to review a given chemical before manufacture or processing for a new use that is significantly different from that described in the original PMN submission, and that would cause EPA concern, such as changes in use that would change or increase human or environmental exposure. Such uses would include major increases in production volume, changes in methods of manufacture or processing or use of a chemical in different types of products. Second, the Section 8(a) information gathering requirements allow EPA to require manufacturers to report information that is needed to fully evaluate the uses, production volumes, descriptions of by-products, health and environmental effects data, or exposure to the chemical. Hence, this "as needed" reporting requirement serves to identify any change in a chemical status not previously identified. FY'83 was the first year in which EPA fully implemented the follow-up program. Since PMN reviews began in 1979, approximately 275 chemicals have been identified as possible follow-up review candidates. During the past year this backlog of follow-up candidates was subjected to a staged review process to determine if there was sufficient toxicity and exposure concern to warrant follow-up action by EPA. In addition EPA promptly acted on those chemicals identified during the year for follow-up action. As a result of the emphasis placed on follow-up, the Agency initiated regulatory action to follow-up after commercialization on 1 ? of these chemicals. These actions took the form of one significant new use rule and ten Section 8 information collection rules. The Agency also prepared documentation explaining why no action was taken on those chemicals for which it found no regulatory action was necessary. In FY'83, EPA adopted a practice of issuing SNURs in conjunction with Section 5(e) orders. A SNUR extends the conditions of the Section 5(e) order to other manufacturers and processors who otherwise could make or process the chemical without the restrictions in the original Section 5(e) order. It ensures that the original submitter does not suffer a competitive disadvantage. In 1983, EPA proposed four significant new use rules in conjunction with Section 5(e) orders; three covering five new chemicals and one on an existing chemical. 12 ------- 4 Existing Chemicals Program ln pyga EPA instituted a new OTS project management Status program for evaluation of risks associated with existing chemicals. This program undertook more than 60 evaluations on chemicals for which: (1) Section 4 test data were received, (2) Section 8(e) notices regarding substantial risk were received, (3) test data have been received from other sources, such as the National Toxicology Program, (4) Section 21 petitions were received, or (5) concerns have been raised consistently during PMN review. The purpose of each chemical evaluation is to consider a chemical's risks in a five-phase process. The phases are termed: entry review, problem characterization, information gathering and risk analysis, risk reduction analysis, and risk management. Only those chemicals for which significant risks are identified will complete all of the phases. Chemicals which are found not to pose significant risks are dropped from further evaluation and the resources are reprogrammed to evaluation of other chemicals. In FY'83 the existing chemicals program received and reviewed a substantial amount of data on existing chemicals. A summary of existing chemical program activities can be found in Table 2. The Section 4 negotiated testing program resulted in submission of 200 completed test studies by industry. Section 8(a) and Section 8(d) rules resulted in submission by the chemical industry of 3,159 studies and reports on existing chemicals. Under the Section 8(e) substantial risk notification program, EPA received 35 initial reports, 59 "For Your Information" submissions, and 94 supplements related to previous initial reports, totalling 188 for FY'83. Twenty-six NTP studies were also received and reviewed by OTS. Chemical Hazard Identification Profile documents were prepared for 20 of the chemicals. Those profiles collect and evaluate the available information on the chemical and identify data gaps. They are used in the first 13 ------- phase (entry review) of the existing chemicals project management program to evaluate risk. The various actions which result from these evaluations include initiation of rulemaking under Section 6 for risk control, under Section 5 for reporting of significant new uses, under Section 8 for information reporting or recordkeeping, under Section 4 for testing and issuance of chemical advisories to inform those concerned of measures that can be taken to mitigate potential risks. As a result of the 64 chemical evaluations undertaken in FY'83, approximately 30 chemicals were targeted for further analyses and decisions in FY'84, eight chemicals were moved into development of Section 5 or Section 8 rules, one chemical, methylenedianiline (4,4'-MDA) was identified as a Section 4(f) candidate, and five chemicals were moved into risk management (Section 6 regulatory development). About 20 chemicals were dropped and the resources were reprogrammed for 20 other chemicals which replaced them in the program. Priority review under Section 4(f) of TSCA identified a number of control actions which could alleviate potential problems associated with 4,4'-MDA. As a result EPA issued an Advance Notice of Proposed Rulemaking (ANPR) in September 1983 on 4-4'-MDA. An ANPR was issued on methylenebis (2 chlorobenzenamine), MBOCA, in May 1983. Three separate rules were proposed or promulgated on PCBs in FY'83. A rule, setting numerical cutoffs for purposes of defining the absence of PCBs in releases from closed/controlled systems, was published in October 1982. This rule also adds additional disposal mechanisms to the list of acceptable practices. Two amendments, one for railroad transformers and one procedural rule regarding approval authority for PCB disposal, were also published in FY'83. Ten Section 8 rules and one SNUR on an existing chemical were issued in FY'83. As each new ITC list is submitted to EPA, the Agency will automatically amend the Section 8(d) rule and propose new Section 8(a) rules to include the chemicals on each list. This will ensure that all available information is submitted to the Agency for use in decisionmaking for Section 4 test rules. The Section 8(d) health and safety rule was amended three times in FY'83 to include ITC chemicals from the 6th-12th lists. A proposed Section 8(a) rule specifically requiring information on chlorinated terphenyls was published on April 29, 1983. Four Section 8(a) Preliminary Assessment Rules were published to trigger automatic reporting on all ITC designated substances and to cover the 6th-9th and 11th and 12th lists of chemicals proposed by the ITC. The 14 ------- Section 8(c) rule discussed earlier was finalized on August 22, 1983. The first existing chemical SNUR was proposed on a category of chemicals known as chlorinated naphthalenes on May 6, 1983. To support its existing chemicals program and to complement the Section 4 testing program, EPA conducts chemical-specific and broad-based monitoring activities. Chemical-specific monitoring is conducted to obtain data on chemical exposure necessary to support regulatory decisionmaking. Generally available information on exposure to existing chemicals is often unreliable or difficult to interpret. Chemical-specific monitoring activities are designed to resolve these problems by measuring actual levels of human and environmental exposure to the specific substance. In addition to chemical-specific monitoring, EPA also conducts broad-based monitoring studies to identify potential regulatory candidates and to define a baseline of exposure to specific chemicals of concern. An example of such monitoring is the National Human Adipose Tissue Survey, the results of which were released by EPA in May 1983. These studies indicated that the estimated percentage of the national population having greater than three parts per million (ppm) levels of PCBs in adipose tissue has decreased from eight percent to one percent from 1977 to 1981. This level had increased from 2.7 percent to eight percent of the population from 1972 to 1977. These results indicate that exposure levels for PCBs have been decreasing. Information from these broad studies helps EPA plan future TSCA ambient monitoring programs, identify candidates for testing under Section 4 or for regulatory controls under other TSCA authorities, and evaluate the effectiveness of TSCA actions in protecting human health and the environment. Existing Chemicals Control The general progress of the Existing Chemicals Control Program has been presented in earlier sections. FY'83 actions on specific chemicals are presented below: Methylene Bis (2-Chloroaniline) - (MBOCA) On May 23, 1983, EPA published in the Federal Register (48 FR 22954) an Advance Notice of Proposed Rulemaking (ANPR) on MBOCA. MBOCA is used as a curing agent in the manufacture of certain polyurethane plastics and has been demonstrated to be carcinogenic in animals. EPA is concerned that the risk from exposure to MBOCA may be unreasonable and is exploring a range of 15 ------- regulatory options including a complete or partial ban. The primary risks from MBOCA appear to be to plastics formulators, generally working in small establishments. Currently there is no OSHA standard for this chemical. 4,4'-Methylenedianiline - (4,4'-MDA) 4,4'-MDA is a high production chemical used primarily as an intermediate to make other chemicals and plastics. In June, 1979, 4,4'-MDA was designated for testing consideration by the Interagency Testing Committee (ITC). In June 1982, the National Toxicology Program (NTP) completed a study which indicated serious carcinogenic potential. Completion of the NTP study was a major factor in EPA's June 1983 decision not to require additional tesing under section 4 of TSCA. However, prompted by this study, evidence of potential high level workplace exposure, and the absence of a Federal workplace standard, EPA initiated priority review of 4,4'-MDA under Section 4(f) in April 1983. As a result of this review, EPA determined that regulatory action was necessary, and jointly with OSHA, issued an ANPR on September 20, 1983. Asbestos Asbestos is a demonstrated human carcinogen. It causes mesothelioma, lung cancer and other cancers, as well as asbestosis. Asbestos has been the subject of EPA TSCA activities since the early years of the program as well as the subject of activity by other Federal agencies. To more effectively coordinate these Federal activities in FY'83, EPA joined several other government agencies in establishing the Federal Asbestos Task Force. Current members of the Task Force are EPA, the Consumer Product Safety Commission, the Occupational Safety and Health Administration, the Food and Drug Administration, the National Institutes of Environmental Health Sciences and the National Cancer Institute. The Mine Safety and Health Administration and the National Institute for Occupational Safety and Health have also been invited to join. During FY'83 EPA also articulated a clear program under TSCA to control exposures to commercial and industrial uses of asbestos. Polychlorinated Biphenyls (PCBs) Section 6(e) of TSCA specifically bans the manufacture, processing, distribution in commerce and use of PCBs with certain exceptions. Section 6(e) also requires EPA to issue regulations regarding disposal and labeling of materials containing PCBs. 16 ------- During FY'83 four final rules regarding PCBs were promulgated in the Federal Register. The first rule, issued on October 21, 1982, (47 FR 46980), set numerical cutoffs (parts per million) for purposes of defining the absence of PCBs in releases from closed and controlled waste processes. The rule also adds additional disposal practices to the list of acceptable mechanisms for the disposal of controlled wastes containing PCBs in concentrations between the limit of quantitation and 50 parts per million. Finally, the October rule instituted new recordkeeping and reporting requirements. The second rule, issued on January 3, 1983 (48 FR 124) amended an earlier rule regarding use authorization for PCB railroad transformers. This rule requires railroad transformers to meet a level no greater than 60,000 ppm concentration of PCBs by July 1, 1984. The third rule, published on February 8, 1983 deals with the updating of analytical test methodology. The fourth issued on March 30, 1983, (48 FR 13181) is a procedural rule regarding approval authority for PCB disposal facilities and guidance for obtaining approval. Chlorinated Naphthalenes and Chlorinated Terphenyls Chlorinated naphthalenes (CNs) and chlorinated terphenyls (CTs) are organic chemicals with a wide range of uses. They were designated for Section 4 testing consideration by the Interagency Testing Committee (ITC) because of possible carcinogenicity and other health concerns. However, the use of chlorinated naphthalenes has declined to low levels, while chlorinated terphenyls are no longer used in the United States. As a result, EPA concluded that test rules were not justified at this time. To ensure against renewed production or expansion of current uses without adequate review, the Agency will monitor these chemicals through Section 5 and Section 8 rules. On April 29, 1983 EPA published a proposed rule in the Federal Register (48 FR 19419) under Section 8(a) which requires manufacturers or importers of chlorinated terphenyls to report to EPA certain information on existing and proposed production. On May 6, 1983, EPA published a proposed rule under Section 5(a)(2) defining a significant new use of chlorinated naphthalenes. Under this rule, any domestic manufacture of chlorinated naphthalenes or any cumulative import over 100,000 pounds a year is considered a "significant new use" and subject to review by EPA under Section 5 PMN requirements. 17 ------- Information Section 8 of TSCA includes several authorities for Activities requiring reporting of production and use information. Section 8 reporting requirements enhance the Agency's ability to make decisions concerning the need for chemical testing or control activities. These requirements also are used to obtain information to support test rule development and risk assessments for the existing chemicals program. Section 8(b) requires the Administrator to compile an inventory of chemicals existing in U.S. commerce during the period of January 1, 1975 through December 31, 1977 and to update the listing of chemicals by adding newly manufactured substances that have been reviewed under the PMN program. The purpose of Section 8(e) is to ensure that information which reasonably supports the conclusions that a chemical substance or mixture presents a "substantial risk" to health or the environment is brought to EPA's attention immediately upon discovery and not solely just upon request by the Agency. "Substantial risk" information received by the Agency may indicate the need for further evaluation which may in turn lead to control. Therefore, each Section 8(e) submission is reviewed by the Agency immediately upon receipt. The information is analyzed in conjunction with other data available to EPA on the reported chemical and its analogs. A status report is prepared for each submission. The status report summarizes the nature of the problem, available data on the chemical, and recommends disposition. The recommendations can range from no further action required to referral to another agency to immediate control. In any case, the reported data are available for use by other programs and agencies that are currently studying the reported chemical. Section 8(e) is a valuable tool in early identification of potential substantial risk situations and helps to focus Agency resources on chemicals of the highest concern. In FY'83 EPA received 35 initial Section 8(e) submissions, 94 follow-ups on initial Section 8(e) submissions and 59 "For Your Information" submissions (not statutorily required). Twenty-nine of the initial submissions were referred for further evaluation within the Existing Chemicals Program while for 28 of the initial submissions the submitter reported instituting voluntary risk reduction measures. Last fiscal year EPA published a final TSCA Section 8(a) Preliminary Assessment Reporting Rule which requires manufacturers of certain chemicals to report general production, use, and exposure information. These data are crucially important to the Agency's review of chemicals 18 ------- 31. designated by the Interagency Testing Committee (ITC). In FY'83 EPA issued four Section 8(a) rules amending the Preliminary Assessment Reporting Rule. As mentioned earlier, two final amendments added chemicals from the 6th through 9th ITC lists and from the 11th and 12th ITC lists to the rule. The Agency also proposed the addition of chemicals listed by the ITC in its 11th report. These actions establish reporting requirements for 51 existing chemicals. Another Section 8(a) amendment established a requirement for automatic reporting by manufacturers of chemicals designated by the ITC. In FY'82 the Agency promulgated a Section 8(d) rule which requires manufacturers of certain chemicals to provide health and safety studies conducted on those substances. By adding each new ITC list to both the Section 8(a) and 8(d) rules, EPA ensures that it will receive current information on those substances under review. In FY'83 EPA implemented another major TSCA information authority. On August 22, 1983 the Section 8(c) Allegations of Significant Adverse Reactions Rule was promulgated. This rule requires manufacturers and processors to keep records of such reactions to health or the environment that allegedly were caused by a chemical. Records concerning health effects on employees must be kept for 30 years; other records i.e., environmental release, for five years. Unlike the other major Section 8 rules, these records are not submitted to EPA but are maintained by industry. Under the rule EPA can require that all records on a specific substance be submitted to the Agency or may require access to the records at the site where they are kept. EPA will use this rule to strengthen and support the existing chemicals program. The Section 8(c) rule will also assist industry to identify substantial risk cases and may trigger reporting to the Agency pursuant to TSCA Section 8(e). In developing TSCA, Congress clearly recognized the need for broad public access to data on commercial chemicals and chemical hazards. It charged EPA with specific responsibility for sharing data obtained under the Act with all interested parties — including Federal, State and local agencies responsible for the protection of health and the environment. EPA's information-sharing responsibilities are especially important because of its unique authority under TSCA to gather or require the development of data on industrial chemicals. This sharing of information is limited only by the confidential business information protection guaranteed by TSCA. During FY'83 several interagency information-sharing activities were conducted. EPA, in conjuction with the 19 ------- Consumer Product Safety Commission, published a technical guidance document entitled Asbsestos in Homes Booklet which provides guidance for detecting and remedying problems with asbestos in the home. In FY'83 EPA published another document entitled Guidance for Controlling Friable Asbestos-Containing Materials in Buildings. The purpose of the report is to supplement previous EPA guidance by emphasizing recent experience and new information on asbestos abatement and control. This document will be most helpful to school officials and building owners who are considering implementing an asbestos»control program. EPA has also worked out a system for sharing Section 8(a) data and Section 5 data with both CPSC and OSHA. 20 ------- 5 Chemical Testing CA ? EPA's chemical testing program is one of the focal points btatUS for tne development and accumulation of test data under TSCA. Test data developed under the authority of TSCA Section 4 narrows the gap of scientific knowledge for other regulatory agencies as well as for EPA. Section 4 of TSCA gives EPA the authority to require manufacturers and processors of a designated chemical to test for certain health or environmental effects. As mentioned previously Section 4 also established an Interagency Testing Committee which designates chemicals for priority testing consideration. The ITC's list of designations is limited to 50 chemical substances at any one time, although additional chemicals may be added as EPA responds to previous designations. The Committee, under the Act, must consider revising its list every six months. EPA must respond within one year to each designation by initiating rulemaking to require testing or by providing reasons for not doing so. In 1979 the EPA was sued by the Natural Resources Defense Council for failure to respond to ITC designations within the statutory deadline of one year. The result of the suit was a court order establishing a three-year schedule to respond to the backlog of chemicals from ITC lists 1 through 6 and to remain current on all newly designated chemicals. By the end of FY'83 the Agency had complied with the statutory deadline for all new ITC designations. (The Agency, by December 31, 1983 eliminated the backlog, as required by the court order). In responding to ITC designations, EPA places considerable importance on developing needed test data rapidly, so potential risks can be identified as soon as possible. As a result, where appropriate, EPA develops negotiated testing programs with manufacturers or industrial consortia, rather than promulgating test rules to obtain these data. This is often in industry's interest as * well as EPA's because, according to industry, ITC designations can place chemical companies at a 21 ------- competitive disadvantage. Therefore, industry has an incentive to complete testing and to clear up any uncertainties as soon as possible. EPA believes that negotiated testing programs are in the public interest and are sometimes preferable to rulemaking because they will provide the needed test data substantially sooner than could be accomplished through rulemaking. If EPA has reason to believe that industry has not acted in good faith, the Agency can still initiate formal Section 4 test rules. In FY'83, EPA responded to a total of 23 ITC designations. Sixteen were backlogged designations and seven were new ITC designations. These produced seven decisions not to test; ten Negotiated Testing Agreements; and six proposed rules. Table 3 reflects FY'83 actions taken on ITC designated chemicals. Test Guidelines Section 4 of TSCA also requires the development and annual review of test standards and guidelines. EPA has developed test guidelines for a wide variety of health and environmental effects. These guidelines are available through the National Technical Information Service (NTIS). To ensure that the guidelines are consistent and of accepable scientific quality, EPA implemented a process that ensures that all guidelines are peer reviewed by scientists in other EPA Program Offices and by expert scientists from academia, State and other Federal agencies, public interest groups and industry. In FY'83 EPA published six new guidelines for conducting basic health and environmental effects and environmental fate testing. These guidelines have been harmonized with the testing guidelines published by the OECD. Section 4 requires EPA to perform an annual review and update of published guidelines to ensure their adequacy. Using responses from solicited public comments and other information gathering procedures, EPA reviews the guidelines to ensure that they reflect the most current and valid testing practices. During FY'83, EPA revised 40 of the 80 guidelines published in FY'82 after determining that technical areas of the guidelines needed updating. All but one of the revisions were minor. Reimburse- ment of Testing Costs 22 To ensure fair distribution among chemical manufacturers of costs connected with performing required testing under Section 4, EPA published a final data reimbursement rule under Section 4(c)(3)(A) on July 11, 1983 (48 FR 31786). ------- The rule sets forth methods for voluntary allocation of costs among those subject to a test rule and provides a framework for the efficient resolution of disputes that the parties choose to refer to EPA, if they cannot come to a settlement. The rule incorporates the procedures of the American Arbitration Association. The arbitration officer hearing these disputes and rendering the initial cost allocation decision would be appointed from the private sector rather than from the Federal government. Quality In order to maintain the scientific integrity of EPA's of Data decisionmaking regarding the regulation of chemical substances, the Agency pursues a rigorous program to ensure the quality of data received as a result of TSCA's testing requirements. In addition to test guidelines discussed previously, EPA scrutinizes in other ways the quality of data upon which it must make crucial decisions. At the close of FY'83 EPA had drafted a rule specifying "good laboratory practices" that must be observed by laboratories conducting tests in compliance with TSCA. At the close of FY'83 this rule was in final review and has now been signed by the Administrator. This rule specifies requirements for recordkeeping and data handling procedures, animal care, personnel qualifications, and similar practices. Also, in FY'83, EPA developed health and environmental data audit procedures to monitor compliance with procedures specified in negotiated testing agreements and Section 5(e) orders. These procedures ensure that audits are conducted in a consistent fashion. In cooperation, EPA's Office of Enforcement and Compliance Monitoring and the Food and Drug Administration, perform periodic inspections and audit testing programs conducted under TSCA. Compliance monitoring personnel inspect the laboratory facility and TSCA program personnel audit the actual test study. In FY'83 13 laboratories and 93 test studies were subjected to audits. 23 ------- 6 Enforcement Under Section 16 of TSCA, EPA may levy either civil or criminal penalties for a violation of several sections of the Act. The Agency has developed specific enforcement strategies for implementing regulations under TSCA. These strategies identify and rank possible violations of a particular regulation, identify the tools available for compliance monitoring and how they will be used, provide a formula for determining the application of inspection resources, and establish a policy for determining civil penalties under the regulation. Civil Enforcement Actions In FY'83, most of the enforcement actions under Section 16 involved alleged violations of the PCB rules. The Agency filed a total of 285 civil complaints during the fiscal year as a result of PCB inspections; 203 cases were completed; and $1,364,652 in civil penalties were assessed. Figures for each EPA Region appear in Table 4. In addition to the PCB cases, the Agency issued six civil complaints to companies for alleged violations of the Section 5 Premanufacture Notification (PMN) requirements and three civil complaints for alleged violations of the Section 6 dioxin disposal requirements. These complaints represent the first PMN and dioxin enforcement actions taken by the Agency under TSCA. Civil penalty assessments for infractions of the PMN requirements totaled $334,000. Criminal Enforcement Actions Criminal cases must be filed on EPA's behalf in Federal court by the Department of Justice. In FY'83, five cases alleging criminal violations were referred to the Department of Justice for consideration. One of these cases, U.S. vs. Baseman, et a/., has resulted in a conviction. Defendent Baseman entered a plea of guilty to two counts under TSCA; one count for illegal interstate transportation of PCB and PCB containers and one count 24 ------- for improper disposal of PCB material. Grand jury indictments were returned in two other TSCA cases which had been referred to the Justice Department prior to FY'83. Compliance Actions The EPA took action to enforce compliance with various TSCA requirements. The EPA, along with-five State agencies cooperating under the terms of enforcement grants-in-aid, conducted 1,633 PCB compliance monitoring inspections. The Agency conducted 19 inspections to monitor compliance with the interagency ban on nonessential aerosol uses of chlorofluorocarbons and conducted 55 inspections to determine compliance with the dioxin rule under Section 6. The Agency also conducted 126 compliance monitoring inspections at facilities subject to Section 5 requirements. During FY'83, the Agency initiated inspection programs to monitor compliance with Negotiated Testing Agreements which were developed in lieu of Section 4 test rules, the Section 6 asbestos-in-schools rule, and the TSCA Section 8(a) level A reporting requirements. The Agency inspected 13 laboratories conducting testing under Negotiated Testing Agreements to determine if the laboratories were in compliance with agreed-upon good laboratory practice requirements. During these inspections, 93 data audits of health and environmental tests were conducted to determine if testing was being conducted in accordance with test protocols, and if reports accurately reflected study findings. Compliance inspections were conducted at 207 local education agencies to determine compliance with the Section 6 asbestos-in-schools rule. The Agency also conducted 83 compliance inspections to determine compliance with Section 8(a) level A reporting requirements. Program Actions During FY 1983, EPA developed and issued compliance monitoring strategies for the TSCA Section 5(h)(4) Premanufacture Notice Exemption for Chemicals Used in or for Instant Photographic or Peel-Apart Film Articles, the Section 6 dioxin rule, the asbestos-in-schools rule, and the Section 8(a) asbestos reporting rule. EPA also issued enforcement response policies for the dioxin rule and the asbestos-in-schools rule, and developed compliance assistance guidelines for the asbestos-in-schools rule. Pilot cooperative enforcement agreements with five States, (California, Connecticut, Maryland, Michigan, and Ohio) continued in FY 1983. These agreements supplement EPA compliance monitoring activities and 25 ------- provide data for use by EPA in developing policy and guidance to support a continuing and expanded cooperative enforcement program with the States. 26 ------- 7 Litigation Environmental Defense Fund, Inc. v. Environmental Protection Agency (Mo. 79-1580, D.C. Cir.) In 1979 the Environmental Defense Fund (EOF) petitioned for review of EPA's regulations under TSCA Section 6(e)(2) and (3) governing the manufacture, processing, distribution, and use of polychorinated biphenyls (PCBs). A decision largely in EDF's favor was issued on October 30, 1980. This decision and its aftermath were described in reports for previous years. Developments of this case for Fiscal Year 1983 are described below. On August 18, 1982, EPA, in response to previous Court orders in this case, promulgated a final rule on the use of PCBs in electrical equipment. Petitions for review of that rule were filed by several parties in the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of Appeals for the Fourth Circuit. EDF also amended its petition for review in the original PCB case. By the end of calendar year 1982 all dockets were consolidated for hearing. The various parties to this consolidated proceeding, in order to reconcile their views on the validity of the EPA rule, began settlement negotiations in early 1983. EPA, EDF and NRDC have since indicated that they may be able to arrive at a separate agreement as to the issues in controversy among them. These parties were close to agreement at the end of Fiscal Year 1983. A schedule with respect to other issues in the case involving other parties is expected to be developed early in Fiscal Year 1984. On October 12, 1982, EPA issued a rule excluding from the restrictions of Section 6(e) of TSCA certain PCBs generated in closed processes or discharged into wastes which are disposed of in an acceptable manner. A petition for review of this rule was filed by the Chemical Manufacturers Association on December 23, 1982. By agreement of the parties, approved by the Court, this petition has been stayed pending further PCB rulemaking 27 ------- On November 1, 1982, EPA requested that the D. C. Circuit Court further extend its stay of mandate until October 1, 1984, to allow further rulemaking for all PCBs not covered in the August and October 1982 rules. On December 17, 1982, the court extended the mandate for an indefinite period, but required the agency to report to it on a quarterly basis its progress in achieving rulemaking. Warren County v. North Carolina (No., 79-560-CIV-5) and Twitty v. North Carolina (No. 80-41 -CIV-5) (E.D.N.C.) These actions were brought by Warren County and private parties against the State of North Carolina and EPA to prevent a tract of land in Warren County from being used as a landfill for the disposal of soil contaminated with PCBs. The cases were decided by the Federal District Court in EPA's favor. Significant events in these actions were described in last year's report. Warren County and the plaintiffs in Twitty filed notices of appeal with the U.S. Court of Appeals for the Fourth Circuit. Warren County voluntarily dismissed its appeal. On December 27, 1982 the Fourth Circuit reaffirmed the decision of the District Court in the Twitty appeal. T. Mitchell Langdon et al. v. James B. Hunt et. al. (No. 86-487-CIV-5, E.D.N.C.) This is another case arising out of the Warren County, North Carolina, PCB situation. It has been described in reports from previous years. On May 17, 1983, the District Court, in accordance with an agreement by the parties, dismissed all claims in this case. The Dow Chemical Company v. Ruckelshaus (No. 82-3536, 3d. Cir.) and The Dow Chemical Company v. Ruckelshaus (No., 80-1498, 3d. Cir.) [The latter case is an appeal from The Dow Chemical Company v. Costle (Civ. Action No. 79-581, D. Del.), described in previous years' reports.] Case No. 82-3536 involves a petition for review of an EPA order assessed against Dow for violation of EPA's PCB regulations. Case No. 80-1498 is an appeal from a judgment in Federal District Court which dismissed Dow's attempt to obtain pre-enforcement judicial review of the regulations appealed in No. 82-3536. The District Court had held that TSCA lodges jurisdiction over preenforcement judicial review of TSCA regulations exclusively in the Court of Appeals within 60 days of promulgation of those regulations. The cases involved related issues and were consolidated in the Third Circuit on appeal. 28 ------- Dow was prosecuted under EPA regulations that require products containing more than 500 parts per million (ppm) PCBs to be labeled. Dow failed to label a product that contained more than 500 ppm monochlorinated biphenyl (MCB). EPA has interpreted TSCA to require it to regulate MCBs as PCBs. That interpretation was questioned in comments on EPA's proposed rule, and Dow challenged that interpretation in enforcement proceedings. At the same time EPA was engaged in rulemaking to replace regulations that were invalidated by the D.C. Circuit Court in EDF v. EPA (described above). EPA was in the process of revising its regulations as they relate to products containing trace amounts of PCBs. On April 15, 1983, certain plaintiffs in EOF v. EPA (EDF, Natural Resources Defense Council, and the Chemical Manufacturers Association (CMA)) jointly submitted a "consensus proposal" for the rulemaking. EDF, NRDC and CMA recommended, among other things, that companies which manufacture up to 1250 ppm of MCBs in their products be exempt from regulation under TSCA. EPA had determined that it intended to include the suggested provisions in proposed regulations and would issue final regulations containing such a provision by July 1984, subject to comments received. Thus, completely independent of the Dow litigation, EPA, at the urging of industry and environmental groups, decided to amend its PCB regulations to make Dow's product subsequently legal. Accordingly, EPA and Dow entered into settlement discussions in Dow v. Ruckelshaus. On August, 2, 1983, EPA and Dow settled the case by agreeing that, if EPA promulgates a final rule that would affect MCBs as described above, Dow would drop its challenge to EPA's interpretation of TSCA and would pay the entire penalty assessed in the enforcement action ($120,000). Metro-North Commuter Railroad Company v. EPA (No. 83-3213, 3d Cir.) and Southeastern Pennsylvania Transportation Authority v. EPA (No. 83-3116, 3d Cir.) Two railroad organizations challenged EPA's regulations to require reduction in PCB concentrations in railroad transformers. Under the regulation, the railroads would have had to reduce one-third of their transformers to 60,000 ppm PCB concentration by July 1, 1983, and eventually, would have had to meet a series of deadlines to reduce all their transformers to 1,000 ppm PCB concentration. The railroads challenged the early compliance deadlines. EPA entered into settlement negotiations with the railroads and, in July 1983, the 29 ------- parties agreed to extend the earliest compliance deadlines, but agreed that, ultimately, the railroads would comply with the 1,000 ppm requirement in all their transformers by the original final deadline of July 1, 1986. Cramer v. EPA (No. 83-1314, D. Kan.) On April 1, 1983, plaintiff filed a citizen's suit under Section 20 of TSCA to require EPA to investigate and prosecute a PCB storage facility near his home in Mound Valley, Kansas. Section 20 authorizes citizen suits to compel EPA to perform nondiscretionary acts. EPA argued that Section 20 does not apply to Agency decisions whether to prosecute, since those decisions are discretionary. Besides, plaintiff has a remedy at law by way of a citizen's suit directly against the storage facility. Furthermore, EPA had already investigated the plaintiff's allegations and had pursued a civil penalty action for which monetary damages were assessed. The case was dismissed by agreement of the parties, with no obligations imposed on EPA. Noble Automative Chemical and Oil Co. v. EPA (No. 81-1581) (D.N.J.) Noble Oil filed suit to enjoin administrative penalty proceedings against it for violations of PCB disposal and marking regulations under TSCA. Noble argued that EPA was acting to enforce regulations which had been invalidated by the U. S. Court of Appeals for the District of Columbia Circuit in EOF v. EPA, supra. EPA argued that the D.C. Circuit's opinion did not affect the disposal and marking regulations and filed a motion to dismiss Noble Oil's case. The District Court dismissed Noble's Suit due to lack of subject matter jurisdiction. Natural Resources Defense Council v. EPA (No. 82-2039, D.D.C) On July 18, 1983, public interest groups challenged EPA's decision not to take steps to place formaldehyde on a priority track for evaluation under Section 4(f) of TSCA. Under Section 4(f), if EPA receives information which indicates that there may be a reasonable basis to conclude that a chemical presents a significant risk of serious or widespread harm to human beings from cancer, gene mutations, or birth defects, EPA shall within 180 days initiate appropriate action under Section 5, 6, or 7 of TSCA to prevent or reduce the risk, or publish in the Federal Register a finding that the risk is not unreasonable. , Plaintiffs claim that EPA's decision, in late 1982, not to evaluate formaldehyde under Section 4(f) was unlawful 30 ------- because EPA applied too strict a standard for triggering the Section 4(f), "significant risk of serious or widespread harm" finding, and because the decision was tainted by unlawful Agency conduct. Plaintiffs claim that EPA had improperly held private meetings with industry groups in the summer of 1982 and had improperly evaluated animal test data. The Agency is now examining the Section 4(f) decision on formaldehyde. There is nothing further to report on the following cases which were noted in last year's report: Olin Corporation v. EPA (No. 79-1437, 4th Cir.) General Electric Company v. EPA (No. 79-1816, D.C. Cir.) Aluminum Company of America v. EPA (No. 79-1811, D.C. Cir.) 31 ------- 8 State Programs State Section 28(c) of TSCA authorizes EPA to award grants to Programs States to assist in programs that prevent or eliminate problems created by toxic substances. Since 1978, EPA has assisted eight States with the development of 11 toxic substances programs. On August 28, 1978, EPA announced in the Federal Register the availability of $3 million for this Federal assistance program and provided guidance to prospective applicants. The announcement also described a two-cycle award process; approximately half the funds were to be distributed in each cycle. In April, 1979, cooperative agreements were signed with Maryland, Michigan, New Jersey, New York, and Wisconsin under the first cycle. In February 1980, cooperative agreements were signed with three States (New Jersey, North Carolina, and Puerto Rico*). On February 11, 1980, EPA annouced in the Federal Register the availability of an additional $1.25 million for a third and final cycle in the program. Cooperative agreements were signed with Illinois, Maryland and Michigan. Refer to Table 5 for the status of these awards. Four State cooperative agreement projects have been completed. These projects are the Michigan Critical Materials Program, the Wisconsin study of health problems related to formaldehyde in mobile home construction, the Maryland Toxic Substances Registry, and the North Carolina toxics management project. * As defined by TSCA, "State" includes any U.S. territory or possession. 32 ------- Table 1 Summary of New Chemical Actions October 1, 1982 - September 30, 1983 Actions Valid PMNs Received Voluntary Testing in Response to EPA Concerns Voluntary Control Actions by Submitters PMNs Voluntarily Withdrawn in Light of EPA Concern PMNs Subject to Section 5(e) Orders PMNs Subject to Section 5(f) Orders Notice of Commencement of Manufacture No. of PMN Actions 1301* 43 1 20 121* 0 316** Aggregate Total Since Beginning (mid-1979) 3012* 53 31 24 132* 0 1232 * This number includes 106 synfuels ** This number includes PMNs received in previous fiscal years for which notices were received in FY'83. 33 ------- Table 2 Summary of Existing Chemical Actions RISK IDENTIFICATION - Action/Chemical # in FY'83 Testing Studies Received Under Section 4 200 Section 8(e) Submissions Received 188 Initial Submissions 35 "For Your Information" (FYI) Submissions 59 Supplemental/Follow up Submissions 94 National Toxicology Program Studies Reviewed 26 (see Table 2A for listing) Chemical Hazard Information Profiles (see Table 2A 20 for listing) Section 21 Petitions 3 GE petition for an amendment to the PCB Rule; denied, 10/20/82 (47 FR 46723). MET Electrical Testing Co. petition for an amendment to the PCB Rule; denied, 4/20/83 (48 FR 16884). Central Michigan petition for an investigation of dioxin and furan pollution; denied, 7/25/83 (48 FR 33739). RISK EVALUATION - Action/Chemical Chemical Evaluations 64 Drop from further evaluation 20 Further analysis required 30 Develop Section 5 or section 8 rules 8 Develop Section 6 rules 5 Section 4(f) Designations 1 Risk Assessments 4 4,4'-Methylenedianiline (MDA) Methylenebis (2-chloroaniline) (MBOCA) Glycol ethers (2-methoxyethonal, 2-ethoxythonal and their acetates) Chloromethane 34 ------- RISK EVALUATION - Action/Chemical (Cont'd) # in FY'83 Section 8 Rules 10 Chlorinated Terphenyl; Submission of Notice of 1 Manufacture or Importation Proposed Rule, 4/29/83 (48 FR 19419). - Records and Reports of Allegations that Chemical 1 Substances Cause Significant Reactions to Health or the Environment; Recordkeeping and Reporting Procedures Final Rule, 8/22/83 (48 FR 38178). Recordkeeping and Reporting Requirements; 1 Recodification Final Rule; Redesignation, 5/25/83 (48 FR 23420). Amendments to Section 8(a) Preliminary 4 Assessment Information Rule: To include chemicals designated in the 6th-9th ITC Lists Final Rule, 5/19/83 (48 FR 22694). To include chemicals designated in the 11th List Proposed Rule, 5/19/83 (48 FR 22697). To include chemicals designated in the 12th List Final Rule, 6/22/83 (48 FR 28843). To require automatic reporting on all chemicals and mixtures designated by the ITC for testing consideration - Final Rule, 5/11/83 (48 FR 21294). Amendments to Section 8(d) Health and Safety 3 Data Reporting Rule: To include chemicals designated in the 6th-10th ITC Lists Final Rule, 3/30/83 (48 FR 13178). To include chemicals designated in the 11th ITC List Final Rule, 12/03/82 (47 FR 54624). To include chemicals designated in the 12th ITC List- Final Rule, 6/01/83 (48 FR 24366). 35 ------- RISK MANAGEMENT - Action/Chemical # in FY'83 Control Rules 6 Advance Notices of Proposed Rulemaking/ 2 Proposed Rules: Methylene Bis (2-Chloroaniline); Initiation of Regulatory Investigation, Advance Notice of Proposed Rulemaking 5/23/83 (48 FR 22954) 4,4'-Methylenedianiline; Initiation of Regulatory Action, Advance Notice of Proposed Rulemaking, 9/20/83 (48 FR 42898) Final Rules: 4 Polychlqrinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions; Use in Closed and Controlled Waste Manufacturing Processes Final Rule, 10/21/83 (47 FR 46980). Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions; Amendment to Use Authorization for PCB Railroad Transformers Final Rule, 1/03/83 (48 FR 124). Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions; Incorporation by Reference Revisions (Updating Analytical Test Methodology) Final Rule, 2/08/83 (48 FR 5729). Polychlorinated Biphenyls (PCBs); Procedural Amendment of the Approval Authority for PCB Disposal Facilities and Guidance for Obtaining Approval; Procedural Rule Amendment and Statement of Policy, 3/30/83 (48 FR 13181). Significant New Use Rules 1 Category of Chemical Substances Known as Chlorinated Naphthalenes Proposed Determination of Significant New Uses - Proposed Rule, 5/06/83 (48 FR 20668). CFC Exemption Requests 1 Fully Halogenated Chlorofluoroalkanes; Denial of Exemption for Use of Chlorofluorocarbons in Aerosol Self-Defense Chemical Weapons Processed for Export Rules Related Notice, 11/18/82 (47 FR 51866). PCB Disposal Permits 2 36 ------- Table 2A Detail Summary on NTP Studies and CHIPs National Toxicology Program (NTP) Studies Reviewed Sodium 2-ethylhexyl sulfate Amosite asbestos 1,2-dichlorobenzene Tremolite Allyl isovajerate toluene diisocyanate geranyl acetate 2,6-xylidine 1,2-dichloropropane 1,1,1-trichloroethane chlorobenzene ethyl acrylate 2-chloro-l-methylethyl-(2-chloroprophyl) ether propyl gallate bis (2-chloro-l-methyl ethyl) ether diallyl phthalate Ziram L-ascorbic acid propylene gilsonite Monuron propylene oxide sodium fluoroscein 1,1,1,2-tetrachloroethane 4,4'-methylenedianiline PBB mixture Chemical Hazard Information Profiles (CHIPs) Prepared C.I. Disperse Yellow, 3, 12/82 D and C Red No. 9, 12/82 Melamine, 12/82 Pentachloroethane, 1/83 iso-Butanol, 3/83 Chlorobenzotrichloride, 2/83 High Explosive, 2/83 n-Propanol, 3/83 Bis (2-chloro-1-methylethyl) Acetaldehyde, 5/83 2,2'-Dithiobis(benzothiazole), 5/83 Tetrabromoethane, 5/83 Chloro-2-nitrobenzene, 6/83 Chloro-4-nitrobenzene, 6/83 Diaminoazobenzene, 6/83 Hexachloronorbornadiene, 8/83 2,3 Dichloro-p-dioxane, 8/83 Dimethylmethy phosphonate, 9/83 Propiontrile, 9/83 Ziram, 9/83 37 ------- Table 3 Date Responses to Interagency Testing Committee (ITC) Designations Chemical Category Action ITC List 10/12/82 Chlorendic Acid 11/01/82 11/08/82 12/16/82 12/16/82 12/29/82 12/29/82 Tris (2-chloroethyl) phosphite Final decision not to test; Release to the environment is limited and such releases are unlikely to present an unreasonable risk Final decision not to test; available data indicate that production and use result in little health risk and there is no known release to the environment. 4-Chlorobenzotri floride Preliminary testing agreement; final negotiated testing agreement- 7/18/83 Toluene Final decision not to test; ongoing health effects testing will be sufficient to respond to ITC concern Xylenes Pyridine Methyl Ethyl Ketone Methyl Isobutyl Ketone (2 substances) 12/29/82 Hexachlorobutadiene 12/29/82 Acetonitrile 12/29/82 Hexachlorocyclopenta- dine 01/06/83 Acrylamide 01/06/83 Antimony Compounds (3 compounds) 01/06/83 Isophorone 05/23/83 Formamide 05/23/83 Ethyltoluenes; Trimethybenzenes and C9 Aromatic Hydrocarbon Fraction (2 substances) 05/23/83 Biphenyl 07/05/83 Mesityl Oxide 07/11/83 Cresols 09/20/83 Methylenedianiline Final decisions not to test; sufficient data have been identified to characterize effects adequately Proposed decision not to test Preliminary testing agreement; final negotiated testing agreement -9/30/83 Final decision not to test; not sufficient basis to find that the current manufacture, distribution in commerce, processing, use of disposal presents unreasonable risk Proposed testing agreement negotiated with industry; preliminary decision not to require testing Final decision not to test; not sufficient basis to find that the current manufacture, distribution in commerce, processing, use of disposal presents unreasonable risk; no substantial or significant human exposure or environmental release; ongoing bioassay Proposed testing agreement negotiated with industry; preliminary decision not to require testing Preliminary testing agreement; final negotiated testing agreement - 9/26/83 Proposed testing agreement negotiated with industry; preliminary decision not to require testing Proposed testing agreement negotiated with industry; ongoing government and industry testing is sufficient Proposed health effects testing requirements Proposed environmental effects testing requirements Proposed health effects testing requirements Proposed health effects testing requirements Final decision not to test; ANPR for control action 9 1 1 2 4 4 4 2 4 4 10 10 &11 10 4 1 4 38 ------- •able Region 1 2 3 4 5 6 7 8 9 10 HG Total 4 Total No. Complaints Issued in FY 79-83 17 100 36 27 185 82 51 45 28 21 4 596 Administrative Civil Actions Taken Under Section 16 of TSCA for Violations of PCB Regulations Complaints Issued, Cases Completed, and Amounts Assessed (by Regions)* No. Complaints Issued in FY 83 9 32 10 15 119 28 29 15 13 13 2 285 Total No. Cases Completed FY 79-83 11 66 28 11 122 61 30 39 20 11 3 402 No. Cases Completed** in FY 83 5 23 11 8 86 21 16 15 10 6 2 203 Total No. of Cases Pending 6 34 8 16 63 61 21 6 8 10 1 194 Total Civil Penalty Assessed (in$) in FY83 56,503 195,230 58,325 36,970 500,784 148,930 77,700 77,800 74,450 17,960 120,000 1,364,652 Total Civil Penalty Amount Assessed (in$) in FY 79-83 88,603 674,530 140,100 60,495 779,704 291,390 127,000 241,100 131,125 32,160 120,000 2,686,207 * All actions taken involved alleged violations of Section 6 PCB rules. ** Includes cases carried over from FY 80 FY 82. 39 ------- Table 5 State/Department Project Grant Descriptions and Status TSCA Section 28 State Cooperative Agreements Program Amount($) Grant Period Illinois Department of Public Health Maryland Department of Health and Mental Hygiene Maryland Department of Health and Mental Hygiene Michigan Department of Natural Resources Purpose: Develop an integrated voluntary system detecting morbidity and mortality rates resulting from exposure to toxic substances. Current Status: Wrote and disseminated a brochure and newsletter to State and local health officials and medical professionals to explain the Environmental Toxicology Program and obtain information on disease clusters and trends in local communities. Follow-up investigations are being conducted by the Department. A guide and a questionnaire are being prepared to assist in epidemiological investigations. State mortality and birth data are being organized and computerized for easier access. Cancer surveillance data from sixteen countries are being completed. In one county, an investigation of birth outcome and maternal history is underway. Purpose: Develop a computer based toxic substances registry. Current Status: The registry now contains information on 250 chemicals, an incidents record, industrial survey reports, all OSHA violations, and a record of all occupationally related diseases. Maryland received a no-cost extension to include birth defects data. The final report has been received and distributed. Purpose: Develop a program to assure the safe and effective containment of toxic substances in storage tanks. Current Status: The contractor, the Ecology and Environment Corporation, has drafted a guidance and procedures manual. Seminars are being conducted. Grantee received no-cost extension to December 1983. 475,626 March 81 to June 84 230,953 April 79 to April 83 100,000 March 81 to Decem- ber83 Purpose: Develop an interdepartmental risk assessment process. Current Status: Many risk assessment models have been reviewed and five major models selected for use by the Departments of Natural Resources, Agriculture and Public Health. Extensive environmental fate data has been gathered by DNR on 90 priority chemicals used or discharged in Michigan and 33 chemical assessments have been completed. The Department of Agriculture continues to sample and analyze for PCB's and heavy metals. The Department of Public Health has developed a computerized data system handling the State's occupational health exposure data. The pesticide toxaphene will be used to test the Michigan risk assessment process. The grantee was granted a no-cost extension to December 1983. 532,258 March 81 to Decem- ber 83 40 ------- State/Department Michigan Department of Natural Resources Project Grant Descriptions and Status Purpose: Critical Materials Program Current Status: This project has been final report was received and summary completed. The distributed. Amount($) 504,500 Grant Period April 79 to Sept. 82 New Jersey Department of Environmental Protection Purpose: Set up a toxic substances investigation and integration unit; expand current project monitoring volatile organic compounds in air. Current Status: Toxic Substances Investigation and Integration Unit has identified and investigated various hazardous waste sites in New Jersey. Cancer and birth defects clusters are being investigated. The mobile monitoring van is completed and is currently operating throughout the State. A final report is being completed. 453,947 April 79 to April 84 New Jersey Department of Environmental Protection New York Department of Environmental Conservation Purpose: Study movement, distribution and uptake of 794,053 in-place mercury; monitor emissions of selected toxic substances; assess the ecological effects of water contaminants; establish and operate a Toxic Substances Information Resources Center; conduct a field application study of in vitro mutagenesis tests. Current Status: Additional sampling of biota has been collected and analyzed for mercury and other heavy metals. Methods and resources required for sampling and analysis of various environmental emissions from selected groups of facilities have been identified and field tested. Research on the effects of environmental stress in aquatic organisms continues. Summary reports of toxic substances research have been prepared along with other educational materials. Waste water samples have been assayed for mutagenic activity using the Ames test. New Jersey was granted a no-cost extension from May 1983 to April 30, 1984. Purpose: Identify, characterize and plan for managing 348,000 toxic substances. Current Status: The grantee proposed to use New York's experience in the Niagara River Project as the basis for a Statewide management plan. This proposal is being revised to include the State's experience in projects other than the Niagra River, and abstract from that project only those characteristics that can be reasonably expected to be applicable to other sites around the State. In order to carry this out effectively, the grantee has received a no-cost extension to June 30, 1984. March 80 to April 84 April 79 to June 84 North Carolina Purpose: Identify, assess and plan to control toxic Office Natural substances by profiling substances; identifying sources, Resources level and duration of exposures; and developing a plan to control toxic substances posing an unreasonable risk. Current Status: The project has been completed; a grant extension has enabled North Carolina to complete 51 chemical guides which have been distributed. 385,000 March 80 to December 83 Puerto Rico Purpose: Develop and manage the Commonwealth's. Environmental toxic substances management strategy; expand an Quality Board existing public participation/ awareness program. 258,394 March 80 to October 83 41 ------- State/Department Project Grant Descriptions and Status Amount($) [?ra.n*. Current Status: Developed and sponsored a meeting for the Inter-Agency Advisory Committee on Toxic Substances Control. Prepared a questionnaire on PCBs for the industrial plants in Puerto Rico and planned inspection visits. An extension until October 31, 1983 was granted to implement part of the strategy. Wisconsin Purpose: Study health problems related to 202,947 April 79 Department formaldehyde vapors from mobile home construction to Social Sciences materials. September 82 Current Status: This study is complete. The final report was received and distributed. 42 ------- Appendix A Summary/Guide to Information Required by Congress Section 30, 28(c), and 9(d) of TSCA require that certain information be reported each year to the President and Congress. To assist readers in locating this information, a summary of each pertinent TSCA action and reference to a more detailed explanation, within this report, is given here. Section 30. This section contains the basic requirement for an Annual Report and requests the following information: (1) Testing. In FY'83, EPA proposed four negotiated testing agreements and finalized six. (See Table 3.) The Agency published seven decisions not to test and one proposed decision not to test. This proposed decision sought additional public comment on the chemical of concern. In addition, on July 19, 1983 a final Section 4(c) TSCA data reimbursement rule was promulgated. See Section 5. (2) Premanufacture Notices (PMN). EPA received 1301 PMNs during FY'83 bringing the total received since the program's beginning in mid-1979 to 3012. (None of these chemicals were subject to rulemaking under Section 4). In approximately 36 cases, voluntary testing or control activities took place in FY'83, while 27 chemicals were subject to the development of either a Section 5(e) or 5(f) order. See Section 3, Program Status and Table 1. (3) Rules Issued Under Section 6. During FY'83, four rules were promulgated regarding PCBs. On October 21, 1982, a final rule was published regarding PCBs in releases from closed and controlled waste processes. On January 3, 1983, a final rule was published regarding use authorization for PCB railroad transformers. On February 8, 1983, a final rule was published which served to update analytical test methodology. On March 30, 1983 a procedural rule was issued regarding approval authority for PCB disposal facilities. See Section 4, PCBs. Advance Notices of Proposed Rulemaking were issued for two chemicals. Methylene bis (2-chloroaniline) (MBOCA) and 4,4'-methylenedianiline (MDA). MBOCA is used as a curing agent in the polyurethane plastics industry. 4,4'-MDA is a high production chemical used primarily as an intermediate to make other chemicals and plastics and poses a serious carcinogenic potential in the workplace (See Section 4, MBOCA and 4,4'-MDA.) (4) Judical Actions Under TSCA and Administrative Actions Under Section 16. All judicial actions concern PCBs except 43 ------- one which concerns formaldehyde. In FY'83 three suits were filed, one petition to review rulemaking was filed, two suits were dismissed, one suit is pending and three suits were settled, including the suit regarding formaldehyde. (See Section 7, Litigation, for details.) A total of 203 PCB civil enforcement cases were completed in FY'83. A total of 194 PCB cases are pending. See full discussion in Section 6, Enforcement. (5) Major Problems. No major problems were encountered in FY'83 in-administering TSCA. (6) Recommended Legislation. No legislative changes are sought at this time. Section 28(c). This section requires a report on grants to States during the year. Four State cooperative agreement projects were completed in FY'83. These were undertaken by Michigan, Wisconsin, Maryland and North Carolina. Seven additional State grants are due to be completed in 1983 and 1984. See description of projects in Section 8, State Programs. Section 9(d). This section requires that EPA's efforts to coordinate its TSCA activities with related activities of other Federal activities be reported annually. During FY'83, EPA continued in several formal and informal agreements with other Federal government programs concerning specific chemical activities. These include a Federal Asbestos Task Force of which OSHA, CPSC, EPA are charter members. Others have been invited to join — Mine Safety and Health Administration, Food and Drug Administration, National Institute for Occupational Safety and Health, National Institute for Environmental Health Sciences, and the National Cancer Institute. In addition EPA, in conjunction with the CPSC, published a technical guidance booklet on asbestos in the home. A joint ANPR on the chemical 4,4'-MDA was coordinated with the Occupational Safety and Health Administration. Other areas include information exchange under Section 8(e) and work with several international organizations. Details on these activities appear in appropriate sections of the report. 44 ------- Appendix B Major FY'83 TSCA Actions Section Description of Law Date 4(a) For Listing of Testing Decisions see Table 3 4(b) Testing Guidelines Published 9/22/83 4(c) TSCA Data Reimbursement Final Rule 7/19/83 4(f) 4,4'-Methylenedianiline 4/18/83 5(a) Potassuim N,N-Bis (Hydroxyethyl) Cocoamine 2/17/83 Oxide Phosphate and Potassuim N,N-Bis (Hydroxyethyl) Tallowamine Oxide Phosphate Proposed Significant New Use Rule Chlorinated Naphthalenes Proposed 5/06/83 Significant New Use Rule 1 Sopropylamine, Distillation, Residues, and 8/24/83 Etylamine, DistillationResidues 1,2 Benzenediamine, 4-Ethoxy, Sulfate 8/30/83 Proposed Significant New Use Rule 5(e) Consent Order; Halogenated Hydrocarbon 1/20/83 Established use of protective equipment Consent Order; Substituted Phenol, 3/09/83 Substituted Pyridine, Sodium 2-Substituted Proponate Requires use of dermal protection for all of the substances, and positive pressure, full facepiece air-supplied respirators Consent'Order; Substituted Pyridine 4/04/83 Requires use of safety equipment and processing controls at manufacturing and processing sites Consent Order; Discarboxylic Acid 4/18/83 Monoester Requires use of protective equipment during processing, application of a label, and a written notice to all workers who may be exposed Consent Order; Shale-Derived Syncrude 5/25/83 Restricts production volume, worker exposure controls and waste handling pending development of sufficient information Order; Two Chlorinated Azo Pigments - 6/23/83 Possible carcinogenic effects Proposed Order; Dyes for Fibers and Fabrics 7/19/83 Possible carcinogenic effects Consent Order; Polyglycidyl amine Restricts 8/16/83 manufacturing processing and distribution in commerce and use Consent Order; 8-acetyl 3-dodecyl 7,7,9, 9/02/83 9-tetramethyl 1,3,8-triazaspiro decane 2,4-diane, Prohibits demestic manufacture 45 ------- and requires workers to use protective equipment during processing. Requires precautionary labels to be affixed to all containers of PMN substances that are distributed. Consent Order; Substituted Nitrile Limits 9/29/83 production to six months pending develop- ment of neurotoxicity and aquatic toxicity testing. Dumping of waste is not permitted until completion of aquatic toxicity text 6(a) Methylene Bis, Advance Notice of Proposed 5/23/83 Rulemaking 4,4'-Methylenedianiline, Advance Notice of 9/20/83 Proposed Rulemaking 6(e) Polychlorinated Biphenyls (PCBs); 10/21/82 Manufacturer, Processing Distribution, and Use in Closed and Controlled Waste Manufactured Processes (Final Rule) Polychlorinated Bipheny|s (PCBs); Use 1/03/83 Authorization for PCB Disposal Facilities (Final Rule) Polychlorinated Biphenyls (PCBs); 2/08/83 Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions; Incorporation by Reference Revisions (Updating Analytical Test Methodology) (Final Rule) Polychorinated Biphenyls (PCBs); Approval 3/30/83 authority for PCB Disposal Facilities (Final Rule) 8(a) Chlorinated Terphenyl Submission of Notice 4/29/83 of Manufacture or Importation (Proposed Rule) Preliminary Assessment Information 5/19/83 Amendment to Include the 6th 9th ITC Lists (Final Rule) Preliminary Assessment Information 5/19/83 Amendment to Include the 11th ITC List (Proposed Rule) Amendment to Add the 12 ITC List to the 6/22/83 8(a) Preliminary Assessment Information Rule (Final Rule) 8(a) Amendments Rule, Automatic Update (Final 5/11/83 Level A Rule) 8(c) Significant Adverse Reaction to Health and 8/22/83 Environment 8(d) Health and Safety Data Reporting 12/03/82 Amendment to include 11th ITC List (Final Rule) Health and Safety Data Reporting 3/30/83 Amendment to Include Chemicals Designated in the 6th 10th ITC Lists (Final Rule) Amendment to Add 12th ITC List to 8(d) Rule 6/01/83 (Final Rule) 46 ------- |