United States Office of Pesticides June 1987 Environmental Protection and Toxic Substances Agency Washington DC 20460 &EPA Toxic Substances Control Act (TSCA) Report to Congress for Fiscal Year 1986 ------- CONTENTS 1. INTRODUCTION 1 2. HIGHLIGHTS 3 PROGRAM IMPLEMENTATION 3 Enforcement 6 International Activities . 6 3. NEU CHEMICALS 8 Program Status 8 PMN Review 9 Exemptions 12 Test Data 12 Fol1owup SNURs 13 Category Evaluations 15 PMN User Fees 15 Bi otechnology 16 4. EXISTING CHEMICALS 19 Program Status 19 .RISK IDENTIFICATION ,, ....-./ .'.... .20 Section 8(c) Records ., 24 Section 8(d) Support to Multiple Programs 25 TSCA Chemical Inventory Update Rule 26 CAIR 27 Chemical Hazard Information Profiles (CHIPs) 27 Substitute Hazard Profiles 28 Section 21 Petitions ...28 Monitoring Activities 29 Underground Storage Tanks 32 RISK EVALUATION 33 Chiori nated Sol vents 33 Risk Assessments 34 Pesticide Inerts Project 35 Chemical Emergency Preparedness Program (CEPP) 36 Chemi cal Category Evaluati on 36 ------- RISK MANAGEMENT 37 Polychlorinated Biphenyls 37 TSCA Ground Water Protection Strategy 39 Quality Assurance 39 Asbestos 39 ASHAA Asbestos Activities » 44 Referrals 46 1,3-Butadi ene 47 Glycol Ethers 47 Toluenediamine 47 MBOCA ' .48 Formaldehyde .49 Chloromethane 49 Significant New Use Rules • 49 PBBs and tris 50 1,2,3,4,7,.7-Hexachloronorbornadiene 50 11-Aminoundecanoic Acid 51 HMPA and Urethane 51 Pentachloroethane 52 Methyl-n-Butyl Ketone 52 Chemical Advisories 53 5.. CHEMICAL TESTING- ,.. '. 55 ' Program. Status ., ... — ;. .55 Test Rule-Development 57 Enforceable Consent Agreements 64 Quality of Data .' • 64 Test Guidel ines 65 6. SUPPORT TO OTHER PROGRAMS, REGIONS, AGENCIES, STATES, INDUSTRY ...66 Program Status .66 INFORMATION DISSEMINATION 67 Chemical Assessment Desk 67 TSCATS 67 GEMS 68 V1deos 68 INDUSTRY COLLABORATION 69 TECHNICAL EXPERTISE 70 STATE PROGRAM 71 MINET 73 ------- 7. COMPLIANCE AND ENFORCEMENT 74 PROGRAM ACTIONS 74 COMPLIANCE ACTIONS 75 CIVIL ENFORCEMENT ACTIONS 76 8. LITIGATION '. 81 9. INTERNATIONAL ACTIVITIES 92 10. RESEARCH AND DEVELOPMENT ACTIVITIES 97 MAJOR RESEARCH ISSUES 97 Test Method Development 97 Structure-Activity Relationships (SAR) 98 Special Human Data Needs 98 Ecology: Transport/Fate/Field Validation 99 Health: Markers, Dosimetry, and Extrapolation 99 Exposure Monitoring 100 Biotechnology/Microbial and Biochemical Pest Control Agents ...100 Engineering Release and Controls 101 Ecology: Ecotoxicity and Risk Assessment 102 Support 103 TABLES . 1. Summary of New-Chemical Actions: October 1, 1985-September 30, 1986 10 2. Summary of Existing Chemical Activities 24 3. PCB Disposal Actions 38 4. Summary of Chemical Testing Actions 58 5. Administrative Civil Actions Taken under Section 16 of TSCA, Complaint's Issued, Cases Completed, and Amounts Assessed (by Region) 80 APPENDICES A. Summary/Guide to Information Required by Congress 104 B. Major FY 1986 TSCA Actions 109 C. Chemical Hazard Information Profiles (CHIPs) ...; 120 D. Substitute Hazard Profiles 120 111 ------- E. Section 4 Test Studies Received 121 F. NTP Studies Received 121 G. FY 1986 Section 21 Petitions 122 H. Summary of Research and Development Activities 123 ------- ABBREVIATIONS AAP Ashestos Action Program ANPR Advance Notice of Proposed Rulemaking ASHAA Ashestos School Hazard Abatement Act BSCC Biotechnology Science Coordinating Committee CAIR Comprehensive Assessment Information Rule CHIP Chemical Hazard Information Profile CMA Chemical Manufacturers Association CPSC Consumer Product Safety Commission EDF Environmental Defense Fund FPA U.S. Environmental Protection Agency FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FWS U.S. Fish and Wildlife Service GLP Good Laboratory Practice HF.SAP Health and. Environmental Studies Audit Program HSWA Hazardous and Solid Waste Amendments IPCS International Program on Chemical Safety IRPTC International Register of Potentially Toxic Chemicals ITC Interagency Testing Committee NBM National Rlood Network NCI National Cancer Institute NFR Notice of Final Rulemaking NHATS National Human Adipose Tissue Survey MIEHS National Institute of Environmental Health Sciences NinsH National Institute for Occupational Safety and Health NPR. Notice of Proposed Rulemaking ------- NSF National Science Foundation NV'F National Wildlife Federation NOC Noble Oil Company, Inc. OFCD Organization for Economic Cooperation and Development OPTS Office of Pesticides and Toxic Substances ORD Office of Research and Development OSHA Occupational Safety and Health Administration OSW Office of Solid Waste OTS . Office of Toxic Substances PAIR Preliminary Assessment Information Rult. PMN Premanufacture Notification RCRA Resource Conservation and Recovery Act SFIH Service Employees International Union SNIIR- Significant New I ISP- Rule TSC'A ' Toxic Substances Control Act IINFP United Nations Environment Program WHO World Health Organization VI ------- 1. INTRODUCTION The Toxic Substances Control Act (TSCA), enacted in 1976, provides the Environmental Protection Agency (EPA) with the authority and responsibility to protect human health and the environment from unreasonable risks arising from the manufacture, distribution, use, or disposal of chemicals. . This ninth annual report to Congress summarizes activities and accomplishments during Fiscal Year 1986, and fulfills the Congressional reporting requirements of TSCA sections 9(d), 28(c), and 30 (see Appendix A). Through TSCA, EPA seeks to prevent or reduce the possibility of injury to the public and the environment from harmful chemicals. The authority of TSCA allows EPA to evaluate and regulate a chemical at any stage in its life cycle including manufacture, processing, commercial distribution, use .and disposal. Programs have been implemented to evaluate chemicals prior to commercialization through premanufacture notification for new chemical substances and new uses of existing chemical substances (section 5); to evaluate existing chemicals by requiring testing (section 4) and reporting of unpublished health and safety data (section 8); and to control unreasonable risks of existing chemicals through regulatory action (sections 6 and 7). EPA may also refer a substance to another Federal agency for action (section 9) in the event that TSCA is not the most appropriate mechanism for controlling the particular situation. In any event, appropriate control actions are instituted after carefully weighing the risks posed by a ------- substance against the benefits it provides and the associated costs of regulation. As a result of these programs, data are being collected on a number of chemical substances subject to recordkeeping and reporting rules* Models have been created to calculate exposures to various toxic substances, and surveys have been conducted to determine current levels of exposure. Test rules, and other approaches to require industry testing where existing data are inadequate, have been developed and are providing valuable toxicity information to support risk evaluation. Laboratory inspections and data audits ensure the quality and integrity of data received from industry as a result of chemical testing. To ensure compliance with regulations, TSCA authorizes both civil and criminal penalties for violations.. Specific strategies' and.tools have been developed and implemented to enforce TSCA regulations. TSCA's ninth year of operation finds EPA enhancing the existing chemical management process, coordinating cross-media toxic evaluations, sharing TSCA acquired information with other programs and Federal Agencies, and expanding the use of TSCA authority to contribute toward the solution of toxic problems identified in various program media. ------- 2. HIGHLIGHTS PROGRAM In FY 1986, EPA advanced all areas of implementation. In addition IMPLEMEN- TATION to meeting the statutory requirements of the Act, EPA focused on data management activities. Major efforts were undertaken to share collected data and technical expertise with other EPA programs, Federal agencies, regions, and States. FY 1986 was the first year that TSCA authority was used to address the chemical problems of other EPA programs and other Federal agencies. The Comprehensive Assessment Information Rule (CAIR) was developed under the authority of TSCA section 8(a) to consolidate many information-gathering requirements into a single rule. As proposed this rule will obtain information to support the assessment and regulation of 47 chemicals identified by EPA, OSHA, NIOSH, and CPSC; other chemicals may be added if necessary. Additionally, the information collection authority of section 8(d) was used to obtain unpublished health and safety studies on 33 chemicals that are subject to the 1984 RCRA amendments, and on another 107 chemicals which were identified by multiple users in EPA and CPSC. Section 4 was also used for the first .time to acquire test data on a chemical, 1,1-dichloroethylene, that is being investigated under the Clean Air Act. TSCA data supported the Chemical Emergency Preparedness Program (CEPP) that was developed in FY 1986 to address sudden accidental releases of chemicals that are potentially acutely hazardous. TSCA data bases were also used to help develop an ------- acute hazard list, of 4fi? toxic substances; these were identified as chemicals that could potentially cause serious human hpalth effects from short-term pxposure. Tn FY 1Q%, the Agency promulgated the Inventory Updatp ^ule requirinq manufacturers and importers to report currpnt production volume and site data on many of the more than K£,nnp chemicals that are on the TSCA Chemical Substances Inventory. Thp rule reprpsents the first update since 1Q77, and includes new substances that have been added to the Inventory after r°view under section 5. Current production volume and site data are imperative in estimating new and existinq chemical exposure?.. The New Chemicals program continues to he one of FPft's ma.ior tools in prpventinq future health and envi ronmpntal problems. In FY 1986, the Agency received ?,?!.?. new ckpmir:al substance notices.' This is the highest annual volume received since the program's incept'ion in 1^79, whrch ^rinos the total number received to date to £,511. Mew chemical substance notices include premanufacture notifications (PMNs), as well as polymer PMMs, low volume exemption notices, and test market exemption applications:. Under section F(e) this ypar, FPfl issued more orders directed to new chemicals than in any other year. The testing requirements that were imposed on PMN submitters last year are beginning to yield toxicity data that support the evaluation of new substances, and enhance rPA's ability to protect human health and the environment from unreasonable risk. ------- Criteria designating certain new biotechnology substances as new chemical substances were developed, as well as scientific tools to assess the risks of these substances. Throughout FY 1986, EPA continued to work closely with Federal agencies and international organizations on biotechnology issues. A Statement of Policy was published in June 1986, describing how five Federal agencies will use existing laws to ensure protection of human health and the environment from biotechnology research and products. Asbestos continues to be a priority concern at EPA, with emphasrs on worker protection requirements for asbestos abatement activities in schools and buildings. In April 1986, EPA published * a final rule effectively extending the protection of the OSHA Asbestos Standard to State and local asbestos abatement workers outside of OSHA-jurisdiction. In January 1'986, EPA proposed a rule which would ban the manufacture, import and processing of certain asbestos products, and phase out the use of asbestos in other products. All products that are not immediately banned would have to be labeled as containing asbestos. EPA also produced several guidance documents that incorporate the latest information on asbestos control and abatement activities. The Chemical Testing program introduced a new approach of using enforceable consent agreements as an alternative to test rules, when consensus can be reached on testing. This approach will expedite testing, while providing, safeguards equivalent to those of test rules. ------- Enforce- In FY 1986, EPA continued to enforce the provisions of TSCA through ment inspections and by issuing civil and criminal compliants where violations were identified. This fiscal year, EPA inspections focused on PCBs (1,639 inspections), and asbestos in schools (2,393 inspections). In addition, the Agency conducted. 1,005 inspections on chemical substance imports, 393 inspections on new chemicals, 452 inspections for compliance with reporting and recordkeeping under TSCA section 8, and 16 inspections of labor- atories for compliance with Good Laboratory Practices (GLPs). In the enforcement area, 781 civil complaints were issued. The majority of these were for- asbestos-in-schools (425) and PCB (323) violations. In FY 1986, the Agency also issued complaints for violations of section 8(a) of TSCA (2), for TSCA section 13 import requirements. (23), and. TSCA section.5 (3). Inter- In FY 1986, EPA" continued to actively participate in international national Activi- programs. Good Laboratory Practice (GLP) experts met and reached' ties agreement on two documents: the Guide for Compliance Monitoring Procedures for Good Laboratory Practice, and Guidance for the Conduct of Inspection and Study Audits. A group of experts met twice in FY 1986 regarding the exchange of confidential information. The group designed a model form for bilateral agreements as well as guidance for countries negotiating such agreements. The Chemical Information Switchboard continued its operations during FY 1986 and increased access to unpublished information on chemicals for its member States. Also during FY 1986, four new test guidelines in genetic toxicology were adopted by the OECO Council; the Updating ------- Panel endorsed revisions to three acute toxicity guidelines, primarily as a result of concern for animal welfare. ------- 3. NEW CHEMICALS .Program The goal of the new chemicals program is to protect human health Status and the environment from the harmful effects of new chemical substances, New substances are defined as those which do not appear on the TSCA Chemical Substances Inventory. Under section 5(a) of TSCA, manufacturers are required to provide FPA with a premanufacture notification (PMN) 90 days prior to manufacture or import of a new chemical substance. Following EPA's review and evaluation of the PMN, if information available to EPA is insufficient to permit a reasoned evaluation of the substance, and EPA-determines that the activities may present* . an unreasonable risk of injury to human health or the environment or that the substance will he produced in substantial quantities and will resu.lt in significant nr substantial human exposure or substantial release to the environment, .a section 5fe) order-may be issued to limit or prohibit manufacture, .import, processing, distribution in commerce, use, or disposal of the substance, pending development of the test data needed to evaluate the potential hazard. Regulations under section R also require manufacturers to sub- mit a Notice of Commencement of Manufacture after PMN review, when actual manufacture begins, at which point the new suhstancp is added to the TSCA Chemical Substances Inventory. Additionally, EPA may monitor new and existing substances that could be of concern should their uses change or production ------- volume increase significantly, via significant new use rules (SNURs). Under a SNUR, any person who intends to manufacture or import a substance for a designated "significant new use" would be required to submit a notification for EPA review much like a PMN. Although the new chemicals program has become increasingly effective, the growing volume of PMNs, has necessitated new procedures to streamline and standardize the review process. In FY 1QR5, for example, EPA implemented two exemption rules which shortened the review period for certain polymers and low volume chemicals. Total new chemical substance submissions, which include PMNs, Tow volume exemption notices, polymer PMNs, and test market exemption applications, reached ?,?13 in FY 1986 fa 20"? increase over the 1,784 in FY 1985). PMN Review Since the beginning, of the HPW chemicals program in 1979, FPA has received 7,356 valid PMNs. In FY 1986, EPA received 1,693 PMNs, thP greatest number received in a sinale year. Most of the new substances reviewed did not reguire regulatory action. The Agency took action on the remainder according to several renulatory options available under TSCA section 5. EPA issued 49 section 5(e) orders controlling exposure to 67 substances, pending development of additional data. In addition, 45 PMNs were withdrawn by their submitters in anticipation of EPA action under section 5(e) or 5(f). Table 1 summarizes new chemical actions. ------- Table 1 Summary of New Chemical Actions October 1, 1.985-Septemher 30, 1986 Actions Total Mew Chemical Substance Submissions Received (PMNS;._Iest Market, Polymer, and ^ Low Volume r — " ^ s < Valid PMNs Received PMMs Requirinq No Further Action Voluntary Testing in Response to FPA Concerns Voluntary Control Actions by Submitters PMNs WitHdrawn in Face- of 5(e)/5(f) PMNs Subject to section 5(e) Consent Orders* PMMs Subject to Unilateral section ^fe) Orders*' PMNs 'Subject to section -5 ff) Rules Number of Chemicals for which Commencement of Manufacture Notices Were Received Submissions of Bona Fide Intent to Manufacture New Substances Subject to Proposed Siqnificant New Use Rules New Substances Subject to Final Significant New Use Rules Test Data Received as a Result of Section R(e) Consent Orders Valid Test Market Exemption Applications Received Granted Withdrawn Denied No. of Actions in FY'86 2,213. 1,693 1,414 18 0 . 47 66 . 0 o 1,098** 543 13*** 1*** 25 56 48 7 0 Aqareqated Total To Hate fsince -mid-107Q) 8,511 7,35fi* ^,7fi! ' fi4 33 139 27! a . 1.2 4 3,678 ?,631 B5 15 ?5 4?7 377 40 6 10 ------- Polymer PMNs Received 233 387 Granted 198 32* Withdrawn 35 RR Low Volume Exemption Notices Received ?34 31.fi Granted 223 298 Withdrawn - 8 11 a Includes lOfi synfuels. *A section 5(e) consent order is issued hy FPA with the agreement of the PMN submitter. A section 5(e) unilateral order is issued hy FPA without the aoreement of the PMN submitter. **This number includes PMNs received in previous fiscal years for which commence- ment of manufacture notices were received, in FY-1986-. ***This number includes substances which were the subjects of PMNs receivpH in previous fiscal years but for which proposed-or final rules were not published until FY 19PR.. 11 ------- Exemptions Certain requirements for exemptions from PMN review or from the full 90-day PMN review process were written into the statute. These include exemptions for research and development (R&D), and test marketing exemptions (TME). Substances manufactured solely for R&D are exempt from PMN review. However, manufacturers of R&D substances must meet requirements set forth in a final rule published in April 1986, clarifying R&D provisions. New substances produced for limited test marketing are subject to an abbreviated 45-day review.. A test marketing exemption application must be submitted for EPA review prior to commencement of test marketing activities. If a manufacturer subsequently wishes to commence full-scale commercialization of the new- substance, a PMN must be submitted for -a full 90-day PMN review. Other exemptions from full PMN review have been created by regulation-.. These include exemptions, for certain polymers and low volume substances. Polymer PMNs and low-volume exemption notices are subject to a 21-day review period. These actions are summarized in Table 1. Test Data EPA may ask for pre-production testing if this can be done quickly and without unreasonable expense, or if the Agency has reason to suspect that potential risk may not be adequately characterized. EPA can issue section 5(e) orders with "testing triggers" if the potential risk can be controlled until a substance reaches a predetermined production volume; production above the stipulated volume requires that test data be submitted. In FY 1986, EPA 12 ------- issued 12 section 5(e) consent, orders with testing triggers. Test data, prompted by section 5(e) consent orders, were received on 25 PMN chemicals. These test data have additional value, as the data are shared with other FPA programs. Followup SNURs 'TSCA authorizes FPA to monitor new and existing substances that may be.of concern if their uses chance, or if production volumes increase significantly from those estimated in the PMN. Under TSCA section 5, EPA may determine by rtilf that certain uses of chemical substances are significant new uses. These rules are referred to as significant new use rules (SNUPsU In manna such a determination, the Agency considers the potential exposure associated with thp us.*3, *"he toxicity associated with the substance and whether the use is ongoing at the time-the rule is proposed. Persons subject to a SNUR must notify FPA at least Q0 days hpfnro manufacturing, import!no, or processinq the chemical substance identified in t>e SNUR for the defined significant new use or uses. A SNUR may be issued for any TSr.A chemical substance, includina individual substances and chemical categories, and for new or existing substances. A SNUR may be written in conjunction with a section 5(e) order. A section 5(e) order can limit or prohibit the use of the chemical substance that is the subject of a SNUR. Once commercial manufacture of a new substance begins, it is placed on the Inventory. If no SNUR is issued, this substance may he manufactured, processed 13 ------- or used hy others without any restrictions. To establish equity nf treatment, EPA issues SNURs on new substances .which are subject 1 section 5(e) orders, thus requirina other persons who intend to manufacture the substances to notify EPA before manufacturino, importing, or processing the substances for any activity other tl those specifically permitted in the section 5(e) order. The Agency also writes followup SNURs for certain new su^s' ; which were not subject to section 5(e) orders. These SNURs address concerns which had not ori.ginally triggered a section 5(e) order either because the concerns arose after the completion of the PMN review, or because-the uses described in the PMN did not' involve enough exposure to warrant action. Followup SNURs allow the Aoency to permit safe uses of potentially hazardous new substances, while ensuring that it Has the- opportunity to review uses which may lead to. signi-f-icant changes in human- or environmental exposure. . • Additionally, EPA develops SNURs which support the existing chemical program's risk assessment an-d risk management activities by monitoring significant new uses of substances that are on the TSCA Chemical Substance Inventory. These SNURs enable EPA to take immediate. followup control action to limit potential exposure resultinq from significant new uses of existing chemical substances. EPA proposed 8 SNURs covering 13 PMN substances in FY IPflfi and promulgated 1 SNIIR covering 1 PMN substance (see Appendix B). In addition to the SNURs on PMN substances, EPA proposed 5 SNURs on 1? existing substances, and promulgated 4 SNURs on 4 existing 14 ------- chemicals under the authority of section 5 (see Appendix B and Chapter 4). Category Evaluations Until FY 1986, new and existino chemical SNDRs were developed on a case-by-case basis, tailored to meet specific circumstances. In April 1986, EPA introduced the listing SNUR for acrylate substances. That SNUR, as proposed will establish in the Code of Federal Regulations (CFR) a list of the significant new uses the Agency routinely designates for acrylates and a list of recnrdkeeping provisions the Agency requires for those significant new uses in a chart format. The chart will contain the name of the substance, references to the appropriate significant new uses selected from the established standard list, and references to the applicable record- keeping requirements'. F'ach time a SNUR is issued for an acrylatp substance an addition will he made to the chart.. This SNHP eliminates the development of new significant new use triggers each time an acrylate SNUR is proposed.. By means of this mechanism, the Aciency hopes to speed up the process of issuing SNURs for acrylates and to make those SNURs more uniform. PMN EPA is planning to use the authority of section ?6(h) to require User Fees a fee for premanufacture notifications, exemption applications and notices, and significant new use notices submitted under TSCA sections 5(a) and (h). The Agency prepared a paper that discussed options for setting a fee and provided preliminary estimates of the economic impact of such a fee. The Federal Register announced the availability of the "Options for PMN Fees" paper in July 1986, soliciting comments on the options it presented. Subsequently, ------- a proposed rule has been developed that will propose the fee option of $100 for section 5 premanufacture notices submitted by small business concerns, $100 for low volume exemption notices, $100 for test market applications, and $2,500 for all other section 5 notices. The proposed rule will be published in FY 1987. Biotech- In June 1986, a Statement of Policy was published describing. nology how five Federal agencies will apply their respective authorities to biotechnology research and products in order to protect human health and the environment from potential hazards. Each of the five agencies is charged with assessing a portion of the risks and benefits resulting from artificial manipulation of the genetic structures of plants,, animals or microorganisms. Existing Federal laws will then provide a basic network of jurisdiction over.-both research and products- Five agency-level committees have been formed. The purpose of EPA's agency-level advisory committee is to provide advice on scientific issues pertaining to biotechnology. The EPA Bio- technology Science Advisory Committee is comprised of 11 members, nine from the scientific community; the other two representing general public policy issues. On July 9, 1986, the first public meeting of the Biotechnology Science Coordinating Committee (BSCC) was held in Washington, D.C. The Committee received oral comments from the public on the Federal biotechnology policy. The BSCC was established on October 31, 1985, 16 ------- and consists of senior policy officials from the agencies involved in the oversight of biotechnology research and products. It is authorized to hold public meetings in order to discuss public concerns about issues involving biotechnology. The Committee was formed by the Federal Coordinating Council for Science, Engineering and Technology, a statutory interagency coordinating mechanism managed by the Office of Science and Technology Policy, which operates out of the Executive Office of the President. Its mission is to coordinate science activities among Federal agencies. EPA is responsible for regulating microorganisms used as pesticides, or for general industrial or environmental purposes. EPA's biotechnology policy gives special consideration to three categories of microorganisms: 1) microorganisms that contain new combinations of traits, or'that are new to the environment in which they are used; 2) microorganisms that are pathogens, or contain genetic material from pathogens, except those that are native to the area where they will be released; and 3) all other microorganisms that are subject to the Federal Insecticide, Fungicide and Rodenticide Act or TSCA, and are deliberately released into the environment. Microorganisms altered to contain genetic material from dissimilar source organisms through deliberate human intervention (intergeneric microorganisms) are considered "new" and are therefore subject to premanufacture notification requirements if they are manufactured for TSCA purposes. This policy became effective when the Statement of Policy was published. 17 ------- Testing in the environment of "new" (inter-generic) micro- organisms will not fall under the R&D exemption from the PMN process that is accorded to other R&D substances. Thus, persons developing "new" microorganisms for commercial purposes will be required to notify EPA prior to environmental releases. Rulemaking will be required to fully implement this component of EPA's policy; until the necessary rule changes are promulgated, EPA expects to be voluntarily notified of such uses. Because of its concern that certain microorganisms will not be subject to PMN policies but should nonetheless be reviewed, EPA expects to complement its PMN policy with a requirement to be notified prior to new environmental uses of genetically engineered micro- organisms that are pathogens or contain genetic material from pathogens. This would be accomplished through a "significant new use rule" issued under section 5(a)(2) of TSCA. Again, until any rule is promulgated, EPA expects" to be-notified, of such releases on a voluntary basis. The Agency intends to require that some information be reported to EPA prior to all environmental uses of microorganisms that are subject to TSCA but not subject to the PMN or significant new use requirements described above. To accomplish this, EPA intends to promulgate a rule under the authority of section 8(a) of TSCA. EPA also intends to consider an exemption from PMN requirements for "new" microorganisms used solely in contained systems and never intentionally released to the environment. 18 ------- EPA must be notified by manufacturers, processors or distributors of microorganisms immediately if they become aware of any new information that suggests that any microorganisms present a substantial risk of injury to human health or the environment. This is not a new requirement; it applies to all substances subject to TSCA. 19 ------- 4. EXISTING CHEMICALS Program The goal of the existing chemicals program is to reduce unreason- Status able risks of injury to health or the environment from chemicals already in commerce. The objectives of this program include identifying potential risks to public health and the environment, evaluating those risks, and when appropriate, addressing those risks with regulatory actions under TSCA or another relevant authority. TSCA addresses all phases of a chemical's life cycle, including manufacture, processing, distribution,..use, and disposal. To identify potential risks, EPA uses the authority of TSCA section 8 to gather information about exposure and toxicity of particular chemicals- When data, are unavailable or insufficient, TSCA section 4 authorizes EPA to require testing by manufacturers and processors.. The Agency makes' a risk assessment of a given--chemical based on analysis of exposure data and health and environmental effects data. From the available information and the risk assessment, EPA makes a decision regarding the need for risk management actions. Alternative risk management actions are identified and evaluated, considering effectiveness and cost factors. The. Agency focuses its efforts on the potential risks of greatest concern and implements the appropriate risk management actions. Provisions of section 5 (i.e., significant new use rules), as well as nonregulatory tools (such as chemical advisories) can be used to monitor or warn of situations 20 ------- which raise some concern, hut do not necessitate immediate regulation. FPA can control unreasonable risks through regulatory action under the authority of section fi, or require immediate elimination of any imminent hazards under section 7. When TSCA is not the most appropriate mechanism for given exnsotire or risk situation associated with a chemical of concern, that chemical will be referred to another Federal authority for action under section 9. Only those chemicals with identified unreasonable ri'sks are addressed in all phases of the program descrihed above. Chemicals that are not found to pose unreasonable risks are drooped from further evaluation; resources are reproqrammed into evaluation of potentially more hazardous chemicals. Ourinq FY 19flfi, 76 chemicals were considered in the Fxistinq Chemicals Program review process, flf that number, fi were referred for information .qathering rules includino testing, and ^1 are undergoing further evaluation. Table ? summarizes existing chemical program activities. Kl 3N IDENTI- FICATION The authority of TSCA section P allows FPA to require reporting and recordkeeping relating to chemical substances and mixtures. Section 8(a) allows FPA to promulgate rules that require manufacturers, importers, and processors to maintain records and report certain information to the Agency. The section P(a) Preliminary Assessment Information Rule (PAIR) requires manufacturers and importers of the chemicals that it specifies to report general.production, use and ?\ ------- exposure information using the rule's Report Form. These data are especially important to the Agency's review of chemicals designated by the Interagency Testing Committee (ITC) for priority testing consideration. EPA may also add non-ITC chemicals to the rule. In FY 1986, EPA developed the Comprehensive Assessment Information Rule under section 8(a), designed to consolidate a comprehensive list of reporting provisions and questions into a model rule. This rule is expected to reduce duplicative efforts within EPA and other Federal agencies as well as industry reporting burdens. This information must be provided to EPA upon request. Under section 8(c), manufacturers and certain processors must maintain records of alleged "significant adverse reactions". In FY 1986, EPA required s-ubmission of such records for the first time. Amendments to EPA's section 3(c) rule in FY 1986 exempt coincidental manufacturers of substances and revise the description of processors Section 8(d) requires certain manufacturers, importers, processors, and distributors to submit lists of unpublished health and safety studies to EPA. In FY 1986 EPA amended the model Health and Safety Data Reporting rule. This model rule requires past, current, or prospective manufacturers, importers and processors of certain named substances to submit unpublished health and safety data to EPA. EPA adds substances to the model rule as the Agency identifies a need for health and safety information. Under section 8(e), persons who obtain new information that reasonably supports the conclusion that a substance or mixture which they manufacture, import, process or distribute presents substantial 22 ------- risk of injury to human health or the environment must notify EPA within 15 workinq Days. These notices are then reviewed and an initial evaluation (status report) is prepared containing, if appropriate, follow-up questions to the submitter, referrals to other agencies, and recommended EPA followup actions. The Aqency also receives a large numher of "For Your Information" (FYI) submissions, submitted voluntarily to the Aqency on chemical toxicity and/or exposure. FYIs are submitted by chemical manufacturers, processors and distributors, trade associations, labor organizations, Federal, State or local anencies, foreign governments, academia, public interest and environmental cirouns, as well as by the general public. Another source of data on existing chemicals risks is the National Toxicology Program, from which test data are routinely received and reviewed. In FY 1986, the existing chemicals program- received and reviewed a substantial amount of.data on existing chemicals (see Table 2). During the fiscal" year, section 8(a) and 8(d) rules were amended to require reporting on 160 chemicals. Section 8(a) and section 8(d) rules resulted in submission by the chemical industry of 362 studies and reports on existing chemicals, Under the section 8(e) substantial risk notification proqram, FPA received 66 initial submissions, 125 supplemental/followup submissions to previous section 8(e) initial reports, and 20F "For Your Information" submissions, totalling 3% for FY 1986. A total of 97 completed test studies required under section 4 were received from industry (see Appendix F.). Twenty-one National Toxicology Program studies were also received and reviewed (see Appendix F). 23 ------- Table 2 Summary of Existing Chemical Activities Risk Identification # in FY 1986 Section 8(a) Preliminary Assessment Reports Received 31 Section 8(d) Health and Safety Studies Received 331 Section 8(e) Substantial Risk Notification Program: - Initial 8(e) Submissions . 66 - Supplemental/Followup 8(e) Submissions 125 - "For Your Information" (FYI) Submissions 205 Chemical Hazard Information Profiles (see Appendix C) 10 Substitute Hazard Profiles (see Appendix D) 17 Testing Studies Received under Section 4 (see Appendix E) 97 National Toxicology Program Studies Reviewed (see Appendix F) 21 Section 21 Petitions Received (see Appendix G) 5 Risk Evaluation # in FY 1986 - Continued assessment 51 - Referred for risk management 3 - No further action required 13. - Section 4(f) designations' 0 - Referred for information gathering 6 Risk Management # in FY 1986 Proposed and final rules under section 6 3 Proposed and-final rules under section 6(e) 1 Chemical' Advisories . 2' •Proposed and final, significant:, new-use. rules 9 Sect.ion 9 Referrals 5 Section EPA published a TSCA section 8(c-) regulation in August 1983, 8(c) Records requiring manufacturers and certain processors of chemical substances and mixtures to keep records of significant adverse reactions to health and/or the environment alleged to have been caused by a substance or mixture. In FY 1986, for the first time since the 8(c) regulation became final, EPA required submission of such records. Two sets of records were submitted on poly- fluorinated or partially fluorinated compounds used in preparations for water and stain repellent treatment of porous materials. The 24 ------- Section 8(d) Support to Multiple Programs Agency used these submissions to determine if the compounds showed similar effects to others observed in animal toxicology studies. EPA promulgated a final rule under section 8(d) of TSCA to collect health and safety data for the Office of Solid Waste (OSW). This rulemaking marked the first time that OTS specifically developed a rule under TSCA authority to collect information needed for another EPA program. The rule requires past, current, and prospective manufacturers, importers, and processors of 33 chemical substances to submit lists and copies of unpublished health and safety studies on those substances to EPA. The mandates of the Hazardous and Solid Waste Amendments of 1984 (HSWA) prescribe statutory deadlines by which EPA must develop land disposal restriction regulations for certain substance-s that are subject to the Resource Conservation and Recovery Act (RCRA). If these deadlines are not met, the HSWA impose an automatic ban on the land disposal of the substances. OSU is devising treatment standards with regard to which health and safety data on the 33 substances are needed. In August 1986, EPA proposed another section 8(d) rule adding 107 chemical substances nominated by EPA's Office of Drinking Water, Office of Water Regulations and Standards, Office of Solid Waste, Office of Toxic Substances, and the Consumer Product Safety Commission. This coordination will lead to resource savings for both industry and the government by avoiding duplicative information requests by multiple offices. 25 ------- TSCA-Chemical The TSCA Chemical Substance Inventory is a list of all chemical Inventory Update Rule substances that are in commerce in the U.S. The data originally reported for the Inventory included 1977 production volume and site data. Since these data are nine years old, their reliability is diminishing. Therefore, in FY 1986, the Agency promulgated a section 8(a) rule that requires manufacturers and importers of certain chemical substances included on the Inventory to report current data on production volume, plant site, and site-limited status. The information collected under this rule will be used by EPA for chemical screening, priority setting, exposure determination,, as well as support, for risk assessment and develop- ment of TSCA regulations. This rule became effective on August 25, 1986. During the initial reporting period, August 25 through December 23, 1986, every manufacturer or importer who produces or imports 10,000 pounds or more, per year of a substance covered by this rule must report separately on every substance at each plant site. After the initial reporting period, the same type of reporting will be required every four years, as long as the rule is in effect. Four categories of substances on the TSCA Inventory are generally excluded from reporting: polymers, inorganic substances, micro- organisms and naturally occurring substances. However, no substance, except one that is naturally occurring, is excluded from reporting if the substance is: subject to an order issued under section 5(e) 26 ------- of TSCA; or subject to a rule proposed or issued under section 4, 5(a)(2), or 5(b)(4), or to a rule issued under section 6 made immediately effective under section 5(f); or is subject of relief granted under a civil action under section 5 or 7. Small businesses, as defined by the rule, are exempted from reporting; even they, however, must report substances which are subject to an order, rule, or action listed above (except section 5(a)(?) SNMJRs). Comprehensive EPA has proposed a model information gathering rule under TSCA Assessment Information section 8(a) to obtain data on the manufacture, import, and Rule (CAIR) processing of chemical substances and mixtures. This model rule- making, called the Comprehensive Assessment Information Rule (CAIR), establishes uniform reporting and recordkeeping require- ments along with a list of questions from which specific information requests <*re to he assembled on a chemical-hy-chpmical basis. This rule would obtain information needed by -FPA, OSHA, ' NIOSH, and CPSC to support the assessment and regulation of d7 chemical substances and mixtures. EPA expects to add other chemicals to the rule in the future; thus, any chemical manufacturer, importer, or processor is potentially subject to it. CAIR is expected.to he time- and cost-efficient both for industry and for the participating Federal agencies. Chemical • In FY 1986, EPA prepared in Chemical Hazard Information Profiles f.CHIPs) Hazard information for 51 chemicals (see Appendix C). A CHIP is a brief summary of the Profiles information that is readily available concerning the health and environ- ------- mental effects and the potential exposure scenario of a particular chemical or chemical class. CHIP candidates are chosen if the information available indicates a potential for adverse health or environmental effects, or if there is evidence of significant production or exposure. Information gathering for a CHIP consists primarily of a search of secondary literature sources, including computerized data bases, scientific review documents, and reference works. In preparing a CHIP, EPA also solicits unpublished information from industry, other government agencies and various other institutions that are involved in chemical risk assessment. Substitute Seventeen Substitute Hazard Profi>es were prepared in FY 1986 as Hazard Profiles part of the overall risk identification and evaluation process (see Appendix D).. Substitute Hazard Profiles, similar in content and. format, to CHIPs, are preliminary risk identification documents'.. If one chemical is~ being considered for risk, management' action under TSCA, these profiles will help to ensure that an even more hazardous chemical is not substituted for the first one. Section 21 Under section 21 of TSCA, any person may petition the EPA Adminis- Petitions trator to initiate a proceeding for the issuance, amendment, or repeal of a rule or order under various sections of the Act. With- in 90 days of when the petition is filed, EPA must either grant or deny the petition. If it is granted, EPA must promptly commence an appropriate proceeding in accordance with section 4, 5, 6, or 8 of TSCA. Denials must be published in the Federal Register along 28 ------- with EPA's reasoning. If EPA denies the petition or fails to act within 90 days, the petitioner may begin a civil action in a U.S. District Court. Five petitions were received in FY 1986, one of which was withdrawn, three of which were denied, and one is pending. A petition that was submitted by the Environmental Defense Fund and the National Wildlife Federation in FY 1985, and partially granted in FY 1.985, resulted in a regulatory investigation of dioxins and furans. The actions taken included a proposed section 4 test rule and a section 8(a), (c), and (d) information gathering rule, both published in December of 1985. In FY 1986, EPA published guidance for preparing citizens' petitions. This guidance is intended to help petitioners effectively present their concerns to EPA with the maximum amount of documentation. Use of this guidance will help the Agency properly evaluate petitions within the mandated 90-day review. Monitoring Several chemical-specific and broad-based monitoring activities Activities were undertaken in FY 1986 to support regulatory decisionmaking on new and existing chemicals. The National Human Monitoring Program (NHMP) monitors the prevalence and levels of exposure to toxic substances in the U.S. population. These data are used to identify trends, assess regulatory efficacy and to provide environmental results measures. In FY 1986, emphasis was placed on increasing EPA's capability to assess existing chemical problems through the use of human body burden data. 29 ------- The National Human Adipose Tissue Survey (NHATS) is currently the main program under the NHMP. The NHATS has been expanded to monitor additional chemical classes by means of a new analytical protocol. To assist in this change, a methods comparability study is underway to compare old and new protocols. In addition, a special study of the unidentified chromatographic peaks from a previous broad scan analysis has resulted in the identification of additional compounds for assessment. EPA and the Veterans Administration are working on a collaborative project to study'dioxin and furan levels in human adipose tissue of Vietnam Veterans and matched control samples of non-Vietnam Veterans and non-veterans. The National Human Adipose Tissue Survey is the source of specimens for this retrospective study. EPA is participating in a cooperative study with the Ecological and Toxicological Association of the Dyestuffs Manufacturing Industry and the American Textile Manufacturers Institute. The purpose of the study is to improve EPA's assessment of exposure and associated risk from the use of powdered dyes in the American textile industry. During the first phase of the survey, a questionnaire was sent to a representative sample of the industry to collect general information. The second phase involves the measurement of actual exposure levels in a representative group of U.S. textile plants. A wide variety of information is being collected characterizing the dye/drug room operations at each site as well as the air samples in the breathing zone of the workers. This study is expected to be completed in late FY 1987. 30 ------- As part of the overall exposure assessment for methylene chloride and five other solvent chemicals, EPA is examining consumer exposure by means of data from a nationwide survey of household usage of products containing these solvent chemicals. Consumers were asked about their frequency, extent, and patterns of use of different household .cleaning, lubricating, painting, and automotive products. The data, which are currently being analyzed, will be used to produce the consumer segment of an overall exposure assessment for these chemicals. As part of the planning of the national survey, a shelf survey was conducted to determine the incidence and levels of methylene chloride in a variety of consumer products. EPA began collecting preliminary information on the presence of chlorinated paraffins in water, sediment, biological tissue, and associated environmental levels. . Samples were collected in the Sugar Creek, Dover, Ohio area. Additional sites will be be evaluated in FY 1987. An ancillary effort to see if chlorinated paraffins can be found in human adipose tissue is also being planned, using the National Adipose Tissue Survey as a mechanism to collect the samples. In support of the PMN program, a series of national surveys was initiated to examine the frequency, duration and amount of consumer use of certain products containing chemicals of interest to EPA. Two surveys examined consumer usage of household cleaning products and painting products, two categories into which many PMN chemicals fall. The information from these surveys will be 31 ------- Underground Storage Tanks used to support the exposure assessment process for new chemicals manufactured for these types of products. The FPA National Survey found that a significant proportion of the nation's estimated 800,000 underground motor fuel storage tanks may be leaking. The National Survey, conducted for FPA's Office of Underground Storage Tanks, was" based on a national probability sample of 890 establishments with.?,400 tanks on thp premises. A random subsa^ple of ?1& establishments was chosen for physical tank testinq, and at these sitps d?3 t.ank s.vstpms were tested for tightness. An estimated 35 percent of fhese tank systems failed the FPA' tightness tost, which ppnuired that the tanks and associated piping be filled above normal operaHnn levels. The information obtained in the survpy will bp n$pd by FPA' when developing regulations to control leaking underground motor fuel' storage tanks.' RISK EVALUATION Major risk evaluation activities in FY 198F focused on the regulatory investigation of formaldehyde and methylene chloridp. The Agency prepared risk assessment documents on six potentially hazardous chemicals. Additionally, a major toxic air pollution strategy was produced by the Agency, indicative of orowing attention to the problem of sudden accidental releases. Chlorinated In FY 1985, FPA, under section *(f) of TSCA, announced that Solvents methylene chloride may present a risk of human cancer from certain exposures. Methylene chloride is a high-volume chemical with a 32 ------- variety of uses, including as a solvent, aerosol . propel lant, and degreaser. In October 19R6, the Agency published an Advance Notice of Proposed Rulemaking (AMPR), announcing plans to conduct a comprehensive interaqency regulatory investigation of exposures to methylene chloride. Other Federal agencies participating include OSHA, CPSC, and FDA. A major issue in the regulatory investigation is that other chlorinated solvents with similar toxicities could he used as substitutes for methylpne chloride. The potential substitutes may not result in significant risk reductions; therefore, the Aoency is assessing the risks and benefits of alt-ernative regulatory apnroaches for six solvpnts (carbon tetrachloride, trichloroethylenp, perchloroethyl ene, trichloroe^hane, CFC-113, and methylene chioridp). The use of other solvents in four use categories (decreasing, dry cleaning, paint stripping and aerosols) are being evaluated. EPA will assess the control measures of several statutes including TSCA, the Clean Air Act, the Safe Prinking Water Act, thp Clean Water Act, and the Resource Conservation and Recovery Act to determine which will be most appropriate in this case. PPA win also consider the regulations administered by other agencies, including OSHA, CPSC, and FDA, as well as whether non-regulatory options could suffice. Risk Six risk assessment documents were prepared in FY IQPfi. The risk .Assessments assessment on the chemical perchloroethyl ene, used as a solvent in dry cleaning and as a metal degreaser, addressed carcinogpnic effects and general population, worker, and consumer exposure. 33 ------- Perch!oroethylene is now part of the chlorinated solvents strategy described above. The risk assessment on 3-chloro-2-methylpronene, an intermediate, addressed carcinogenic effects and exposure from manufacturing and emissions. This document was prepared for the State of Maryland. The risk assessment on l,4-dichloro-?-hutene, also an intermediate, addressed workplace exposure and carcinogenic effects. The document was prepared for OSHA, NIOSH, and the manufacturers of l,4-dichloro-2-hutene. A risk assessment on acrylamide, an intermediate in polyacrylamide manufacture, addressed carcinogenic and systemic toxicity as well as mutagenicity. Exposures to manufacturing workers and workers doina sewer line grouting are expected. The risk assessment on paradichlorohenzene, us^d as a deodorizer and moth repellant, addressed carcinogenic risk to consumers. A final risk assessment addressed formaldehyde, used in wood products, and in-moMle and conventional homes huilt w-ith. urea-formaldehyde. Pesticide EPA developed a proposed strategy for reaulating the toxic and Inerts Project potentially toxic inert ingredients that are used in pesticide products, in order to minimize public health and environmental risks. Of the 1?00 substances identified as inerts, most have been tested only for acute toxicity, hut not for their potential chronic effects such as cancer and hirth defects. The 1200 inerts have been divided into four different categories: toxic inerts (List 1 - known human and environmental effects); potentially toxic inerts (List ?.)• inerts of unknown toxicity (List 3); and inerts of minimal hazard (List 4). 34 ------- The Office of Pesticide Programs (OPP) is reviewing the 55 substances on List 1 in order to assess the extent of exposures and risks each poses and subsequently to determine what, if any, regulatory action is warranted. The Office of Toxic Substances (OTS) is responsible for managing the review of approximately 60 inert substances on List 2 which have high priority for testing. This involves gathering any relevant data in the published literature, data developed under EPA and other governmental testing programs, and data submitted to EPA under TSCA section 8. OTS will work with OPP to identify significant data gaps and to determine which mechanism under FIFRA or TSCA is most.appropriate to obtain the necessary toxicity data. EPA will then use these test data to determine if an inert should be placed on List 1 for further action or on List 4 because of minimal hazard. Chemical In December 1985, EPA announced the development, of a voluntary Emergency Prepared- program to address accidental releases of chemicals that could be ness Program acutely hazardous. The Chemical Emergency Preparedness Program (CEPP) was designed both to increase community awareness of potential hazards and to stimulate the development of State and local emergency plans for responding to chemical accidents. CEPP produced a guidance document which included an introduction to the program, sections on developing community emergency contingency plans, gathering and analyzing site specific information, contingency planning appraisal, and criteria to identify acutely toxic chemicals. An interim list of 402 acutely toxic substances that have the 35 ------- potential to create an emergency situation accompanied the document, plus information profiles on these substances. The guidance includes a procedure to determine the minimum quantities of concern for these chemicals. Chemical EPA is evaluating the potential application of categorical approaches Category Evalua- for risk assessment of several groups of chemicals. This evaluation tion includes a review of the health or environmental concerns, 'exposure, and economic aspects of these categories. The categories under review were selected based on the experience of both the new and existing chemical programs. The main criteria for their selection for this review were concerns about the toxicities of several of their constituent members and high levels of current activity in the new or existing chemical programs. A decision is expected in early FY 1987 on whether any of these categories, should enter a more detailed analysis to determine the-need for regulatory activity. RISK MANAGEMENT Risk management activities in FY 1986 resulted in TSCA section 6 actions or section 9 referrals on polychlorinated biphenyls, asbestos, 1,3-butadiene, glycol ethers, formaldehyde, MBOCA, toluenediamine and chloromethane. The Agency also developed section 5 significant new use rules (SNURs) to monitor new uses of substances on the TSCA Chemical Substances Inventory, including PBBs, Tris, methyl £-butyl ketone (MBK), hexachloronorbornadiene (Hex-BCH), hexamethyl phosphoramide (HMPA), urethane, 11-amino- 36 ------- undecanoic acid (11-AA1, and pentachloroethane. Descriptions of some siqnificant FY 1986 activities are presented below. Polychlorinated Biphenyls In FY 1986, EPA made substantial progress in developino a nationwide policy for the cleanup of spilled PCPs. This policy is being developed to establish consistent nationwide standards for the cleanup of PC3s in soil and on surfaces such as concrete and asphalt. The Agency hopes that by publishing its standards for cleanup, industry will move quickly tn conduct thorounh cleanups with minimal oversiaht by FPA. The existing process involves consultation with the Regional offices prior to cleanup and has led to protracted cleanups in some cases. In FY 1°86, EPA continued to implement the TSCA section *(e) prohibitions on polychlorinated biphenyls fPCRs) by is^m'na a final rule in August 1986 that ^responded-to ??. petitions for exemption from the prohibition against, manufacture, processinq, and distribution in commerce of PCRs; 16 were granted, ? were denied, 1 was granted in part and denied in part, and ? were dismissed. TSCA provides that EPA may grant exemptions if (1) the Administrator finds that there would be no unreasonable risk to health or the environment, and (?.} good faith efforts have been made to develop a chemical which does not present an unreasonable risk, and which may he substituted for PCR. In April 1986, EPA published "PCR Transformers and the Pisk of Fire: A Guide for Ruilding Owners," an information leaflet designed 37 ------- to improve compliance with the final PCB Transformer Fires Rule published in FY 1985. EPA continues to promote industry participation in the development of PCB destruction methods with the objective of attaining safe handling of these toxic chemicals. Accomplishments in FY 1986 include the issuance of 10 research and development (R&D) permits, 9 demonstration permits, and 5 nationwide disposal permits (see Table 3). Table 3 Actions on Nationwide PCS Disposal Permits FY 1986 Applications Received: 18 R&D Permits Issued: 10 Permit Deficiency Letters: 16. Demonstration Permits Issued: 9 Nationwide Final Permits Issued: 5 38 ------- TSCA The TSCA Ground-Water Protection Strategy focuses on sources of Ground- Water ground-water contamination that are not presently being emphasized Pro- tection by other Agency programs. In FY 1986, the TSCA Strategy Strategy concentrated on collecting information on the following potential sources of ground-water contamination: septic tank systems; agricultural chemicals outside the jurisdiction of FIFRA; fertilizers used on lawns, gardens, and shrubbery; and volatile organic.chemicals released through leaks, spills, and dumping, especially by small industries and commercial establishments. The Agency will use this information to develop strategies for preventing or mitigating ground-water contamination from these sources. Quality The Office of Toxic Substances Quality Assurance (QA) program is a Assur- ance dynamic and integral part of all intramural and. extramural projects requiring environmentally related measurements. A major strength of the QA program is the commitment and awareness that management, at all levels within the program office, has with respect to quality assurance. Through this commitment, and in concert with a program which is practiced on a day-to-day basis, the OTS Quality Assurance Program Plan was approved by the Agency's Quality Assurance Management Staff. The OTS was one of the first program offices to receive this approval. Asbestos On April 25, 1986, EPA issued a final rule under TSCA to protect State and local government employees from the potential hazards of 39 ------- asbestos abatement work. This rule effectively extends Occupational Safety and Health Administration (OSHA) worker-protection require- ments for asbestos abatement to State and local employees who perform asbestos abatement work. OSHA is normally responsible for the Federal regulations protecting workers, but the Occupational Safety and Health Act does not give it authority to cover State and local government employees. However, 23 States and territories have set standards for State, and local employees that are at least as strict as OSHA's worker-protection rules. In addition, EPA decided that four other States,. Idaho,. Kansas,. Oklahoma- and Wisconsin, have. regulations that-are comparable to or more stringent than its rule.. The EPA final regulation thus applies to the remaining 23 States only. The EPA regulation is similar to.; the. exist-ing OSHA. standard'-in both the exposure 1imits it establishes and the maximum concentration it allows at any one time. It also requires work practices such as wetting of asbestos, use of personal protective equipment and provision of special clothing. Furthermore, it requires environmental monitoring, the posting of caution signs, cleanup, and proper disposal of'asbestos waste, as well as medical examinations for certain employees and the retention of medical examination and environmental monitoring records. However, the EPA rule does not cover routine repair of less than three linear or three square feet of friable asbestos material. Thus, minor routine repairs of pipe insulation by sealing or taping would be exempt. 40 ------- In January 1986, EPA proposed a rule under section 6 of TSCA to ban the manufacture, import and processing of certain asbestos products. The Agency also proposed to phase out asbestos use in other products, and to require labeling of any product that contains asbestos and is not banned. Labeling would ensure that persons working with the products would know they contain asbestos, and enable them to reduce the likelihood of exposure. Under section 6, EPA proposed to prohibit five asbestos products: roofing felts, flooring felts, vinyl-asbestos floor tile, asbestos cement pipe and fittings, and asbestos clothing. In addition, all remaining domestic mining and importation of asbestos would be phased out over a 10-year period. The 10-year phase out that affects other products would be accomplished via a transferable permit system, under which EPA would allocate permission to mine or import, a specific volume of asbestos per year. EPA is considering additional approaches to address the risks associated with asbestos products, including the ban of categories of asbestos products, such as asbestos construction products and .asbestos friction products, at staged intervals. In encouraging the development of substitutes, EPA is promoting a significant reduction in risk. The products that are currently replacing asbestos appear to present lower risk. However, EPA will monitor the development of substitutes, and will use TSCA to require that the substitutes be tested, if that measure seems necessary to ensure their safety. In August 1986, EPA published an advance notice of proposed 41 ------- rulemaking soliciting comments on the future direction of its program to reduce risks from asbestos in schools. EPA currently uses guidance and technical assistance, with limited Federal regulation, to motivate schools to abate asbestos risks. EPA is considering whether to continue with the status quo or to implement its current approach more aggressively or to selectively incorporate a greater emphasis on Federal regulation. After review of these comments, EPA may propose further regulatory requirements under section 6(a) of TSCA. In FY 1987, EPA expects either to propose additional Federal regulations or publish reasons why it believes additional regulations are not. necessary.. The study, "Evaluation of Asbestos Abatement Techniques; Phase I: Removal", completed in FY 1986, concluded that it is possible both to remove asbestos-containing material from a school, and to achieve 'low'airborne levels after that- removal, by means of post-reTnoval cleanup., EPA selected four schools in-one suburban school district for the study because the district was already committed to an asbestos removal program. The study also concluded that transmission electron microscopy (TEM) provides the clearest documentation of changes in airborne asbestos levels. Two other analytical methods in addition to TEM, scanning electron microscopy and phase contract microscopy, were studied. The study, "Evaluation of Asbestos Abatement Techniques; Phase II: Encapsulation With Latex Paint," was published in FY 1986. The study concluded that high airborne asbestos levels can occur within the work site during encapsulation and that airborne 42 ------- asbestos levels can be significantly reduced after encapsulation of asbestos material, although it is impossible to predict how long this reduction will last. Because airborne asbestos levels can be high within the work area during encapsulation, containment barriers should always be used to prevent contamination of the rest of the building, and workers involved in the project should' wear respirators for protection while in the containment area. Air samples for this field study were collected at a variety of sites in a suburban school undergoing encapsulation with latex paint. The samples were analyzed with Transmission Electron Microscopy. In the "Asbestos Abatement Efficacy Study—Phase III", air level samples were monitored in schools with students present to determine the effectiveness of the asbestos removal that had taken .place-during the previous summer. Sampling was completed in November 1985; results will be published in FY 1987; EPA completed a random sampling scheme for friable surfacing materials in buildings. The scheme is contained in the document, "Asbestos in Buildings: Simplified Sampling Scheme for Friable Surfacing Materials." Pertinent statistical support is detailed in the document, "Statistical Support for Asbestos in Buildings: Simplified Sampling Scheme for Friable Surfacing Materials." EPA also finalized "Measuring Airborne Asbestos Following an Abatement Action." This guidance document discusses methods for determining when an asbestos abatement project has been completed 43 ------- satisfactorily, a process which involves both air monitoring and sample analyses. ASHAA Effective in FY 1986, Congress included tough new restrictions Asbestos Activities for Federally-funded asbestos work in schools. Now all on-site supervisors and a majority of the hired asbestos abatement workers must either be State-certified or have attended EPA-approved asbestos abatement training courses. With these restrictions in place, Congress appropriated $50 million in FY 1986 under the Asbestos School Hazard Abatement Act (ASHAA) to aid those primary and secondary schools with a severe asbestos hazard who cannot afford to abate the hazard on their own. EPA- awarded $47'million in grants and loans to 173 of the Nation's neediest public and private school districts, to help perform 421 asbestos abatement projects in 295" schools.. All of the-1,777 schools that applied. for ASHAA funds in 1986 were- ranked on a national scale, based on the extent of the health hazard the friable asbestos posed to students and employees. EPA decided how much money each school district was to receive on the basis of that ranking. Each school authority then decides on the most effective remedy: removal, encapsulation or enclosure of the asbestos. Most of the EPA-supported schools chose asbestos removal. The legislation has authorized EPA to spend $600 million over seven years to abate asbestos in qualifying schools. Fourteen States already have certified programs for contractors; within a year an additional nine States should have 44 ------- qualified certification programs. Meanwhile, EPA is funding the National Association of Minority Contractors to conduct training in New York City, Detroit, and Los Angeles. These courses will be EPA-approved, and will meet the congressional requirement. In 1986, EPA approved a number of asbestos abatement training courses for supervisors and workers. EPA-funded training facilities are located in (Georgia Tech) Atlanta, (University of Kansas) Kansas City, (Tufts) Boston, (the University of Illinois) Chicago, (the University of Texas) Arlington, TX, (the University of Utah) Salt Lake City, (Drexel University) Philadelphia, and (Rutgers University) Piscataway, NJ. The University of California at Berkeley is funded by EPA to offer EPA-approved courses. EPA expects to begin approving other courses for the ASHAA program within the next few months. The National Asbestos Council (NAC) and the Committees on Occupational: Safety and Health also have received EPA approval and are receiving Agency funds to conduct abatement worker training courses. These programs are designed for nonsupervisory workers in the abatement industry. NAC can send field personnel to a particular project location for on-site training. Under the ASHAA program for contractors in States without training requirements, a training course that has been approved by any State certification and training program is an EPA-approved course. For example, the Association of Wall and Ceiling Industries (AWCI) training course is approved by Alabama. As a result, the AWCI course is acceptable not only in Alabama, but also in any 45 ------- other State that has no certification and training programs. Referrals In FY 1986, the EPA Administrator signed separate agreements with the heads of two other Federal agencies to enhance interagency control of toxic substances. These agreements coordinate and streamline the way TSCA section 9(a) actions are handled by EPA, the Occupational Safety and Health Administration (OSHA) and the Consumer Product Safety Commission (CPSC). The intent of the two memoranda of understanding is to promote more efficient EPA administration of TSCA section 9(a) actions, in order to better conform with the responsibilities of OSHA and CPSC. EPA, OSHA and CPSC have different, though related, responsibilities and objectives with regard to.toxic substance control. In order to regulate a toxic substance under TSCA, EPA must make a finding of unreasonable risk -of injury to health or the environment. The Occupational Safety and Health Act, enacted in 1970, requires OSHA to demonstrate that there is a significant risk to employees from a substance in the workplace, in order to regulate it. CPSC administers three laws that could be used in certain circumstances to address those risks that EPA would otherwise process under TSCA. These acts are the Consumer Product Safety Act, the Federal Hazardous Substances Act and the Poison Prevention Packaging Act. 1,3-Butadiene In October 1985, EPA referred 1,3-butadiene to OSHA for regulatory 46 ------- consideration. EPA presented its conclusion that the manufacture of 1,3-butadiene and its processing into polymers presents an unreasonable risk of cancer to workers. EPA has determined that this risk may be prevented or reduced to a sufficient extent if action is taken under the Occupational Safety and Health Act. Glycol Ethers In FY 1984, EPA initiated a regulatory investigation under TSCA to explore the^need for reducing worker exposure to two glycol ethers, 2-ethoxyethanol and 2-methoxyethanol, and their acetates. Studies indicated that glycol ethers produced adverse reproductive and developmental effects in animals at low doses. The Agency determined that a workplace standard of the same type as the current OSHA standard can sufficiently reduce risk for workplace settings where glycol ethers are used, manufactured, formulated or processed. In May 1986, EPA -referred the class- of glycol ethers to CPSC under the authority of TSCA section 9(a), Toluenediamine In July 1986, EPA announced termination of its investigation of work- place exposure to toluenediamine (TDA). In accordance with TSCA section 9(d) EPA transmitted to OSHA its public record pertaining to this issue. EPA made this decision because the chemical's potential risks in the workplace are properly a matter of concern for OSHA. Subsequently, EPA issued a Chemical Advisory to inform manufacturers who use TDA that it is a probable human carcinogen. The Chemical Advisory also suggests ways to reduce worker exposure. EPA will continue to investigate the environmental hazards posed 47 ------- by IDA in non-occupational settings. 4,4'-Methylene Bis(2-ch1oroani1ine) (MBOCA) In June 1986, EPA announced termination of its regulatory investi- gation of MBOCA, which had begun in May 1983. EPA transferred its public file on the chemical to OSHA, in accordance with section 9(d) of TSCA. OSHA has statutory authority to prevent, or reduce to a significant extent, the risks associated with the processing and use of MBOCA in the workplace. OSHA has been kept informed of EPA activities during the latter's regulatory investigation of this chemical. EPA had previously issued a Chemical Advisory to all MBOCA processors-in tha United. States., The-Agency also issued a TSCA section 8 reporting and recordkeeping rule which requires persons to notify EPA if they currently are manufacturing MBOCA in this country,, or if they begin-manufacturing the-substance or alter their method of manufacture-.in the future.. The rule excludes importers from its reporting requirements. It enables EPA to evaluate activities which may result in exposure to MBOCA, and to take followup regulatory action, if necessary, to reduce risk to human health or the environment. Formaldehyde In May 1984, EPA determined under section 4(f) of TSCA that exposure to formaldehyde may pose significant risk of widespread harm to the large number of persons who either live in mobile and conventional homes made with urea-formaldehyde wood products, or who manufacture apparel from fabric treated with formaldehyde-based, durable-press resins. 48 ------- In March 1986, EPA published a notice announcing that the Agency was ending its investigation of the risk posed by formaldehyde exposure in the workplace, including the risk to manufacture apparel workers, and was sending the information it had developed to OSHA. Uith respect to the risks posed by exposures in mobile and conventional homes, a risk assessment document was prepared in FY 1986; regulatory options will be considered early in FY 1987. Chloromethane In May 1986, EPA referred chloromethane to OSHA, under TSCA section 9(d), for consideration of potential carcinogenic and systemic toxicity risks at the current OSHA Permissible Exposure Limit (PEL). Signifi- Once a final SNUR (TSCA section 5{a)(2)) for a substance is issued, cant New Use a person who intends to manufacture, import or'proeess the Rules ... • substance for a significant new use is required to. notify EPA at least 90 days before beginning such activity. A substance listed in a SNUR is generally subject to the same statutory procedures as those required under TSCA's PMN rule for a new chemical substance. The purpose of the SNUR notice requirement is to furnish EPA with the opportunity to evaluate the intended use of the substance and, if necessary, give the Agency enough time to prohibit or limit the use before its inception. PBBs and Tris EPA proposed a SNUR for eight polybrominated biphenyls (PBBs) and for tris 2,3-dibromopropyl phosphate, also known as Tris. 49 ------- In this proposed rule, EPA indicated that any use or related activities involving PBRs or Tris may result in significant human or environmental exposures. Even though these substances are listed on the TSCA Inventory, EPA is not aware of any use of them in the United States since at least 1980. In 1977, EPA began to investigate the need to control PRRs and Tris under TSCA. In 1980, EPA issued a TSCA section fl(a) rulp reguiring submission of a Notice of Manufacture or Importation for PB^s and Tris. That rule included a "sunset provision" that terminated the reporting requirements for those chemicals by May 1, 19RB. Since then, EPA has reassessed the toxicity of PRRs and Tris, past and present exposure, and the need for further information about these chemicals. The Agency decided a SNUR would provide the information. 1,2,3,4,7,7-Hexachloronorbornadi pne In November 1985, EPA issued a final rule reguiring certain manufacturers, importers, and processors of 1,?,3,4,7,7-hexachlorn- norbornadiene (Hex-RCH) to submit a section 8(aj report; and other manufacturers, importers, and processors of Hex-BCH to submit a significant new use notice under section 5(a)(2). The reports and notices will allow EPA to monitor the volume of Hex-RCH manufactured, imported, and processed; the number of individuals exposed; the manner of environmental release; and the method of disposal. EPA will evaluate the reported information to determine if further regulatory action is appropriate. 50 ------- 11-Aminoundecanoic Acid In July 1986, EPA. proposed a SNUR to require manufacturers, importers, and processors of 11-aminoundecanoic acid (11-AA) to submit a significant new use notice for any use except as an intermediate in the manufacture of nylon 11 in an enclosed process. At the same time, EPA also proposed, under TSCA section 8(a), that manufacturers, importers, and processors of 11-AA who are not covered by the SNUR notification requirements notify EPA of prospective manufacture, import, or processing of this substance. Both requirements would provide EPA with the -information needed to determine if further regulatory action is warranted to control exposure. HMPA and Uretnane EPA issued a final SNUR for two substances, hexamethylphosphoramide (HMPA) and urethane, because they are expected to be hazardous to health, and their use may result in significant human and environmental exposures. Both substances are known animal carcinogens and suspected human carcinogens. Neither substance has been imported into the United States, nor manufactured nor processed here, for some time. The SNUR requires that any person who intends to manufacture, import or process either substance for any use must submit a significant new use notice to EPA. Pentachloroethane EPA proposed and promulgated a SNUR to require persons to notify 51 ------- the Agpncy at least 90 days before beginning the manufacture, import, or processing of pentachl.oroethane for any use. At one time, pentachloroethane was used as an intermediate in the production of tetrachloroethylene. The Agency believes that initiation of a significant new use of pentachloroethane could result in significant human exposure. The rule will furnish FPA with information needed to evaluate an intended use, and allow the Agency to take steps to protect against potentially adverse exposures to this substance before such exposures can occur. ^ Methyl n-Rut.yl Ketone (MRK) In July 19Sfi, FPA proposed a SNUR for methyl n-butyl ketone- (MRK)., EPA believes M5K can cause neurotoxic effects in humans, and any use of it may result in significant human exposure. The substance has been* used as' a solvent" for lacquers and in lacquer and varnish removers.. MRK also.has been used as a sol vent. for-'Oi Is,..fat's1 and waxes'. In 1979, the1 only known- MBK manufacturer in the- United States discontinued production of the substance and sold the last of its inventory in 1981. MRK is not now being imported into the United States. Chemical EPA uses Chemical Advisories to inform individuals or organizations Advisories about toxic effects of certain chemicals, exposures which are of concern, and alternative methods of reducing risks. They are developed after consultation with interested parties, including companies, public interest groups, and other agencies. Chemical Advisories are designed to he used where increased awareness of ------- potential risk is likely to lead to meaningful precautions, and are addressed and.distributed to individuals or organizations for whom the information is most useful. They are intended to encourage voluntary risk reduction actions by individuals or organizations in instances where regulatory control is not appropriate, or as interim measures while regulatory action is pursued. In FY 1986, two Chemical Advisories were issued, addressing hazards from burning used motor oil and 2,4-toluenediamine. The Chemical Advisory on burning used motor oil addresses the problem of potential exposure to lead and other combustion products from improperly vented space heaters. Small workplaces, such as garages and service stations, often heat by burning used oil drained from gasoline-powered engines. This oil contains lead that has been deposited in the engine as a by-product of fuel combustion. When the used oil is burned in undented heaters', lead in the exhaust gases enters the workplace air. Excessive lead levels in inhaled air can cause toxic effects in humans, including nerve and irreversible brain damage, kidney failure, anemia, high blood pressure, various blood and metabolic disorders and gastrointestinal disturbances. Lead particles may also be deposited on workplace surfaces. These particles can be ingested inadvertently, increasing the total exposure. The Advisory was distributed in November 1985 to com- plement a proposed rule by the Office of Solid Waste, under the Resource Conservation and Recovery Act (RCRA). As proposed, that rule would ban burning used oil in unvented space heaters. 53 ------- The second Chemical Advisory, completed in September 1986, advises .manufacturers of products that contain 2,4-toluenediamine to minimize worker exposure to these products. 2,4-Toluenediamine causes cancer in laboratory animals and is considered by EPA to be a probable human carcinogen. This Advisory also suggests ways to reduce exposure. Workers may be exposed to TDA by inhalation or .ingestion of vapors or particles, and by skin contact. TDA is shipped and handled in either molten or solid state. When molten TDA is handled, any vapors which escape into workplace air may condense into fine particles and be deposited on clothing or on work surfaces,, making them available-for absorption through the skin. TDAs in the solid state have low vapor pressure and do not normal'ly present an inhalation hazard. 54 ------- 5. CHEMICAL TESTING PROGRAM Program Data obtained through testing are used by EPA and others to determine Status whether and how to regulate or control potentially hazardous chemicals. Section 4 of TSCA gives EPA the authority to require manufacturers or processors of chemicals to test for certain health or environmental effects. A test rule specifies the chemical to be tested, health and environmental effects for which testing is required, test standards, schedules for submission of data, and who is responsible for conducting the testing. To require testing EPA must find that a chemical may present an unreasonable risk, that there are insufficient data available with which to reasonably determine or predict the effects of the chemical, and that testing is necessary to generate such data. A test rule may also be based on an EPA finding of substantial production and exposure to humans and the environment. In June 1986, EPA issued an Interim Final Rule that amended the existing regulations for the development-and implementation of testing requirements under section 4 of TSCA. The amendment establishes procedures for using enforceable consent agreements to require testing under section 4. This rule will allow EPA to negotiate with manufacturers, processors, and other interested parties to establish testing programs that satisfy EPA testing needs. An enforceable consent agreement may be adopted in a case where consensus on an industry test program is reached in a timely manner by EPA, affected manufacturers, processors, and other interested parties. If timely consensus cannot be reached or 55 ------- appears unlikely, EPA will invoke the pertinent rulemaking procedure, as specified in the Act. The Agency believes the consent agreement process will lead to the development of necessary test data significantly earlier than formal rulemaking. The Interagency Testing Committee (ITC) continues to designate chemicals to EPA for priority testing. The ITC is comprised of appointed members from eight Federal agencies, as specified in TSCA. Representatives from six additional Federal agencies serve in a liaison capacity. EPA must respond to chemical designations within twelve months either by initiating rulemaking or by giving reasons for not so doing. The ITC may designate up to 50 chemicals or categories of chemicals for testing; it must consider revising its' list, and report to EPA at least every six months. To date, the use of section 4 authority to obtain data through testing has been primarily in response to ITC-designated and recommended chemicals; however, two new. uses of this' authority were introduced in FY 1986. First, EPA developed a test rule in response to a citizens' petition filed under section 21 of TSCA. The proposed test rule would require manufacturers and importers of fourteen commercial organic chemicals to test these substances for the presence of chlorinated and brominated dioxins. EPA will ultimately issue a decision that indicates either that no further action is warranted, or that regulatory action is warranted in the form of controls to limit the amount of these materials manufactured and released. Second, EPA developed a test rule in support of priority data development activities of another Agency program, 56 ------- the Office of Air Quality Planning and Standards. In 1985, 1,1-dichloroethylene was considered for regulation as a potentially toxic air pollutant under the Clean Air Act, but available information was insufficient at that time to support a decision to regulate. The Agency proposes to obtain the data needed to better assess the chemical's oncogenic potential via section 4. Test Rule In FY 1986, EPA took a total of 38 ITC-related actions. Development Of these, 12 were responses to new ITC designations, and 26 were post-initial response determinations. These produced 13 proposed rules, 9 final rules, 10 proposed test standards, and 6 decisions not to test. Other testing actions produced an additional 4 proposed rules. Table. 4 presents a summary of all testing actions taken in FY 1986. 57 ------- Date Table 4 Summary of Chemical Testing Actions Testing in Response to the Interagency Testing Committee (ITC) Chemical Action ITC List 08/26/85 2-Chloro-l,3-butadiene (Chloroprene) 10/18/85 4-Chlorobenzotri f1uoride 10/30/85 Octamethylcyclo- tetrasiloxane 1.1/06/85 Cumene 11/06/85 Mercaptobenzothiazole Decision Not. to Test; 15 available data are sufficient; EPA is not requiring environ- mental effects or chemical fate testing at this time. Decision Not to Test; data 9 available to the Agency, including data received pursuant to a negotiated testing agreement, are adequate for health, environmental, and chemical fate effects; no further testing is required. Notice of Proposed Rulemaking; 15 proposes that manufacturers and processors conduct chemical fa.te and. environmental effects tests; Notice of Proposed Rulemaking; 15 proposes that manufacturers and processors perform testing for pharmacokinetics, subchronic toxicity, oncogenicity, mutagenicity, neurotoxicity, developmental toxicity and reproductive toxicity; if triggered, acute and chronic aquatic toxicity in saltwater and freshwater fish and invertebrates, and biodegrada- tion and volatilization from water. Notice of Proposed Rulemaking; to 15 perform chemical fate and environ- mental effects testing including persistence and mobility, chronic aquatic toxicity, pharmaco- kinetics, developmental toxicity, reproductive toxicity, neuro- toxicity and chromosomal aberrations. 58 ------- 11/06/85 Anthraquinone 11/06/85 Sodium N-Methyl-N- Oleyltaurine 11/06/85 Fluoroalkenes 11/13/85 Pentabromoethylbenzene U/27-/85 Propylene Oxide 11/27/85 Propylene Oxide 12/19/85 1,1,1-Trichloroethane 12/20/85 Mesityl Oxide 12/20/85 Mesityl Oxide 59 Notice of Proposed Rulemaking; to 15 perform testing for water solubility, bioconcentration and acute toxicity to aquatic organisms. Testing for bio- degradation and chronic toxicity of aquatic organisms, will be required if the acute toxicity or bioconcentration test results and the annual production and importatioQ level meet specified criteria. Decision Not to Test; existing 15 information on health effects does not suggest potential for an unreasonable risk at expected exposure levels. Notice of Proposed Rulemaking; 7 to perform health effects testing of vinylidene fluoride, vinyl fluoride, hexafluoropropene, and tetrafluoroethane. Notice of Proposed Rulemaking; 1R to perform testing for chemical fate and environmental effects. Notice of Proposed Rulemaking- 1 Test Standards; proposes TSCA test guidelines for develop- mental toxicity be used as test standard for the required study and that test data be submitted within a specified time frame. Notice of Final Rulemaking; 1 requires developmental toxicity testing. Notice of Final Rulemaking; 3 promulgates testing in accordance with proposed test standards and reporting requirements. Notice of Proposed Rulemaking- 4 Test Standards; proposes that certain TSCA test guidelines be used as test standards for the required studies and that test data be submitted within specified time frames. Notice of Final Rulemaking; 4 requires testing for chronic effects, mutagenicity, and oncogenicity if triggered from mutagenicity test results. ------- 12/30/85 Hydroquinone 12/30/85 Hydroquinone 12/30/85 Quinone 01/06/86 Phenylenediamines (o-f m-, p-) 02/27/86 Formamide 03/27/86 Ethyltoluenes 03/27/86 Trimethyl benzene Notice of Proposed Rulemaking- 5 Test Standards; proposes that certain TSCA test guidelines and industry-submitted guidelines be used as the test standards for the required studies and that test data be submitted within specified time frames. Notice of Final Rulemaking; 5 requires testing for reproductive, teratogenic and nervous system effects and that the chemical's toxicokinetics be evaluated. Decision Not to Test; data 5 received in response to the proposed rule indicate human and environmental exposure to quinone are so low as to be unlikely to present an unreason- able- risk to-humans or the environment. Notice of Proposed Rulemaking; 6 proposes testing of 0-, m-, p-POA for their chemical fate and environmental toxicity and. m-PDA for mutagenic effects and oncogenic. effects if triggered by mutagenicity test results. Decision Not to Test; data 10 available, includi-ng data received pursuant to a negotiated testing agreement, are adequate to character- ize formamide for health effects; no further testing is required at this time. EPA may propose rulemaking to monitor any significant change in exposure to the chemical. Notice of Proposed Rulemaking- Test Standards; proposes that protocols submitted by the American Petroleum Institute, with minor additions as proposed by EPA, be adopted as test standards; establishes schedules for the testing. 10 10 Notice of Proposed Rulemaking- Test Standards; proposes that protocols submitted by thfe American Petroleum. Institute, with minor additions as proposed by EPA, be adopted as test standards; establishes schedules for the testing. 60 ------- 04/07/86 Chlorinated Benzenes (Environmental) 04/07/86 Chlorinated Benzenes (Environmental) 04/10/86 Diethylenetriamine 04/28/86 Cresols 04/28/86 Cresols 05/15/86 'Methylcyclopentane 05/15/86 Tetrabromobisphenol A 05/15/86 Triethylene Glycol Monomethyl Ether 05/15/86 Triethylene Glycol Monoethyl Ether Notice of Proposed Rulemaking- 1,3 Test Standards; proposes that certain TSCA test guidelines be used as the test standards for the required studies and specifies time frames for test submissions. Notice of Final Rulemaking; 1,3 promulgates EPA's decision to require environmental effects and chemical fate testing. Notice of Proposed Rulemaking- 8 Test Standards; proposes the adoption of study plans and schedules fate testing. Notice of Proposed Rulemaking- 1 Test Standards; proposes that certain TSCA test guidelines be used as the test standards for the required studies and specifies time frames for test submissions. Notice of Final Rulemaking; 1 requires mutagenic effects, developmental t-oxicity, and reproductive .effects testing/ studies. Notice of Proposed Rulemaking; 16 to perform testing for neuro- toxicity, subchronic toxicity, and inhalation and dermal pharmacokinetics. Notice of Proposed Rulemaking; 16 to perform testing for chemical fate and environmental effects. Notice of Proposed Rulemaking; 16 to perform subchronic toxicity, developmental toxicity, neuro- toxicity, mutagenicity, repro- ductive toxicity, and onco- genicity testing. Notice of Proposed Rulemaking; 16 to perform subchronic toxicity, developmental toxicity, neuro- toxicity, mutagenicity, repro- ductive toxicity, and onco- genicity testing. 61 ------- 05/15/86 Triethylene Glycol Monobutyl Ether 07/08/86 Chlorinated Benzenes (Health) 07/10/86 Biphenyl U/ i eurdi.ii i uruueruene 08/04/86 2-(2-Butoxyethoxy)- ethyl acetate 09/09/86 1,2-Dichloropropane Notice of Proposed Rulemaking; 16 to perform subchronic toxicity, developmental toxicity, neuro- toxicity, mutagenicity, repro- ductive toxicity, and onco- genicity testing. Notice of Final Rulemaking; 3 requires manufacturers and processors to conduct cfhcogenicity testing of 1,2,4- TCB; reproductive effects testing of MCB, 1,2- and 1,4-DCBs; repro- ductive effects and developmental toxicity testing of 1,2,4,5-TCB. This action also terminates rule- making process for subchronic/ chronic and oncogenicity testing of 1,2,4,5-TCB. Notice of Proposed Rulemaking- 10 Test Standards;, proposes that industry-submitted study plans and schedules be adopted, with certain revisions, as the test standards and reporting deadlines for the required testing.. Decision Not to Test; announces 3 EPA is not at this time continuing rulemaking~to require environ- mental effects testing. Notice of Proposed Rulemaking; to 13 perform health effects testing for subchronic toxicity; neuro- toxicity/behavioral effects; developmental neurotoxicity; pharmacokinetics; mutagenicity; oncogenicity and dermal absorp- tion testing. Notice of Proposed Rulemaking- 3 Test Standards; proposes that pharmacokinetic testing be con- ducted using TSCA test guidelines for the required studies and that test data be submitted within specified time frames. 62 ------- 09/09/86 1,2-Dichloropropane 09/18/86 Bisphenol A Notice of Final Rulemaking; requires manufacturers and processors to test for neuro- toxicity, mutagenicity, repro- ductive effects, developmental toxicity, as well as acute and chronic toxicity to aquatic invertebrates and acute toxicity to algae. Notice of Final Rulemaking; requires manufacturers and processors to conduct a 90-day inhalation study with particular emphasis on pul- monary effects. EPA is ter- minating the test rule process for acute and chronic aquatic toxicity testing. 14. Other Testing Actions 12/19/85 Polyhalogenated Dibenzo-p-di.oxins/ Oibenzofurans 05/15/86 Commercial Hexane 08/04/86 Diethylene Glycol Butyl Ether Notice of Proposed Rulemaking; requires manufacturers and importers of 14 commercial organic chemicals to test for the presence of chlorinated and brominated dioxins and furans. Testing would also be required on 20 other organic chemicals (not now commercially manufactured in the U.S. or imported) if manufacture or importation resumes. Notice of. Proposed Rulemaking; to perform testing for acute and subchronic toxicity, oncogenicity, reproductive toxicity, develop- mental toxicity, mutagenicity, neurotoxicity, and inhalation and dermal pharmacokinetics. Notice of Proposed Rulemaking; to perform health effects testing for subchronic toxicity; neurotoxicity/ behavioral effects; developmental neurotoxicity; pharmacokinetics; mutagenicity and oncogenicity. 63 ------- 08/12/86 1,1-Dichloroethylene Enforceable Consent Agreements Quality of Data Notice of Proposed Rulemaking; to conduct distribution, excretion and metabolism (DRM) studies and a two- year inhalation oncogenicit.y Mnassa.y, Oncoqenicity testing would be delayed until after DEM data Have been completed and evaluated. To initiate the enforceable consent agreements neootiation process, EPA publishes a solicitation of interested parties in the Federal Register which 1) announces its tentative evaluation of testing needs for a given chemical, ?) announces a public meeting to discuss such testing,, and 3) requests all persons desiring to have the status of "interested parties" in any negotiations on the-chemical to notify EPA of their interest. Since publication of the Interim Final Rule, FPA has published such solicitations on two ITC-designated chemicals, - two'non-ITC designated chemicals and one'chemical cateoory.. In order to maintain *~he scientific integrity of EPA's' decision- making regarding the regulation of chemicals, the Agency pursues a rigorous program to ensure the quality of the data received as a result of test requirements meeting established criteria. In FY 1984, the Agency promulgated Rood Laboratory Practice (GI..P) standards (48 FR 53922-53944, November 29, 1983). The RLPs specify procedures for conducting health effects and environmental effects testing under TSCA, and requirements for facility operations, maintenance of equipment and recordkeeping. To ensure compliance with the GLP standards and with testing requirements under TSCA and FIFRA, FPA's • Office of Compliance Monitoring is responsible for conducting fi4 ------- laboratory inspections, and for auditing completed test studies. Inspection staffs are drawn from EPA headquarters, Regional Offices, and from the Food and Drug Administration (FDA). The Office of Toxic Substances provides scientific and technical support to the Office of Compliance Monitoring through its Health and Environmental Studies Audit Program (HESAP). HESAP staff participate in laboratory audits and.review test data resulting from ongoing industry testing and test rules. Inspection and study audit reports from EPA Regional and Headquarters Inspectors are reviewed, and regulatory actions recommended as appropriate. In FY 1986, 16 laboratory inspections were conducted and 65 test studies were audited under section 4 testing authority. See Chapter 7 for detailed compliance and enforcement actions. Test Section 4 of TSCA also requires the-development and annual review Guidelines • of test standards and guidelines.. Tb ensure consistency and scientific quality, all new guidelines are peer-reviewed by scientists and experts within the Agency and in the academic community, State and Federal agencies, public interest groups, and industry. During FY 1986, EPA published one new test guideline, "Indirect Photolysis - Screening Level Test", and published revisions to 37 guidelines. 65 ------- 6. SUPPORT TO OTHER PROGRAMS, REGIONS, AGENCIES, STATES, INDUSTRY Program The Office of Toxic Substances (OTS) made a major effort in FY Status 1986 to inform other EPA program offices and regional offices, other Federal agencies, and States about the chemical information collected under TSCA sections 4, 5 and 8; about potential uses of TSCA in filling information or control gaps that cannot be obtained through other legislative authorities; and about the technical expertise (i.e., risk assessment, structure activity, modeling) that is available for cross-media activities. Since many other programs address priority chemical exposure problems, OTS feels that these programs can benefit greatly from its unpublished health and safety information, and from its >xpertise. Several activities have been discussed in the previous chapters [i.e., in Chapter 4, CAIR, section 8(d) information gathering, CEPP; and in Chapter 5, test rule develop- ment support]; however, additional significant accomplishments cannot be categorized under a specific program. These are discussed in this chapter. Two formal mechanisms were established to assess the needs of other program offices and to determine how to best meet these needs. The Committee for Programs' Regulatory Use of TSCA examines potential uses of TSCA, uses of OTS technical expertise by other programs, and the potential impacts of both on existing OTS programs. The Testing Priority Committee 66 ------- (TPC) examines the technical merits of program offices' requests for testinq under TSCA. The TPC has established a standing procedure for the nomination of chemicals, satisfying multiple proaram needs, for testing under TSCA as well as other testing mechanisms. In addition, the TPC serves as a forum for information exchange with respect to ongoing and planned testing. INFORMATION DISSEMINATION Chemical Assessment Desk TSCATS OTS has collected a wealth of unpublished data on chemicals as a result of various section a and 8 rules, and has gained much exper- ience in evaluating new and existing chemicals (i.e., hazard, exposure, source, risk assessment, modeling). OTS makes its information and expertise available through the activities below, and is continuina to explore methods to. enhance the accessibility of TSCA data to outside users. The Chemical Assessment Desk pilot project was introduced in ^arch to provide consultation on chemical toxicity and exposure potential, based on available OTS information and evaluations plus information from other EPA programs. The project's initial client, Region 8, has referred approximately 20 issues to the Chemical Desk to date. In August 198fi, the pilot project was expanded to include Region 10. Regions 1, 4, and 9 will be added by the end of calendar year 1986. In December 1985, EPA. implemented the Toxic Substances Control Act Test Submissions (TSCATS) data base, which is an online 67 ------- index to tne compiled unpublished health and safety studies that have been submitted to EPA from chemical manufacturers and processors. This is non-confidential information that can be made available to the public. Users include Federal and State agencies, researchers, risk assessors, trade and professional associations, and toxicologists. The data base contains over 10,000 citations that cover more than 1,?00 unique chemical substances. Used in conjunction with published material, the data can help formulate hazard evaluations and risk assessments. GF.MS The Office of Toxic Substances has several information and model ing-systems available to hplp States deal" w-ith their toxic- related problems and projects. Among the most, important is the Graphical Exposure Model ing System. (GFMS"), which features chemical property .estimation and- envi ronmenfal partitioning fate, and exposure models, and draws upon a wide range of demo- graphic and environmental characteristics data. Videos In FY 198fi, FPA produced 4 videos to provide the public with information, clarification, or guidance on TSCA regulations. TSCA Inventory Update: An Overview for Chemical Manufactures and Importers was produced as an instructional videotape to aid persons required to report during the partial updating of the TSCA Inventory. TSCA: Balancing Risks and Benefits was produced to provide general information on TSCA's preventive risk/benefit fiR ------- INDUSTRY COLLABORATION approach, review of new chemicals before they are in commerce, information-gathering on chemicals of concern, and related issues. The videotape is designed to explain the Act to public health organizations, State governments, labor oraam'zations, public interest groups, a.nd'universities or secondary schools. Deducing the Risks of PCBs explains the history of PCB regulation under TSCA, and the effect of PCBs on health and the environment. The video also focuses on the general requiregents of the rules, including disposal requirements, registration of PCB transformers with fire departments, notification of huildinq owners, and the filiag of an annual inventory report. This tane is dpsianed to explain PCBs to the utility industry, fire departments, building owners, and scrap and salvage Hpalers. npn't Blow It! was produced for brake and fleet garaqe mechanics and vocational schools; it provides information on potential health hazards from exposure to asbestos in brake dust, as well as step-hy-step methods to effectively control brake dust. A February 19P6 workshop reviewed the methods currently available to assess workplace exposures to chemicals, given limited data only. The workshop convened EPA, industry, and academic representatives to address concerns about inhalation exposure, dermal contact, engineering controls, and respiratory protection. For many participants, the workshop served to clarify thp regulatory, temporal, and economic limitations under which FPA ------- operates its new chemicals program. The workshop also enabled EPA to draw upon considerable external expertise to help advance the technical tools and procedures the Agency uses to assess new chemicals and workplace exposures. Another example of industry collaboration was a national conference on risk communication held in January 1QP6. The conference was co-sponsored by the Conservation Foundation, the National Science Foundation, the American Industrial Health Council, and the University of Southern California. Government, industry, environmental, and consumer leaders discussed new and practical ways to communicate about health, safety, and environmental risks from hazardous wastes, nuclear energy, and pesticides. TECHNICAL EXPERTISE In addition to providing test rule development and data-gathering support, OTS made its expertise available to other EPA programs. One particular example of a unique scientific expertise OTS possesses is the Office's ability to evaluate the potential hazards of chemicals for which adequate test data are lacking. Through its experience in assessing new chemical substances over the past six years, OTS has developed a special expertise and recognition in the application of structure-activity relationships (SAR) to the evaluation of chemical hazards. During FY 1P86, OTS assisted a number of other groups by providing high quality hazard assessments of a variety of poorly studied chemicals. For example, OTS assisted the Office of Pesticide Programs in evaluating the health ------- and environmental effects of 37 pending pesticide inert inqredients. OTS also assisted the Office of Solid Waste and Emergency Response (OSWER) hy providinq SAR-hased analyses of potential carcinooenicity and chronic toxicity of 515 chemicals on the Comprehensive Environmental Response, Compensation and Liability Act fCFRCLA) "Reportahle Quantity" list. During FY 1QS6, OTS also assisted several States and EPA reqions as well as the U.S. Departments of State and Defense by providina SAR-hased analysis of a variety of chpmicals including environmental pollutants, chemical tracking agents, research and development chemicals, etc. OTS technical expertise supported the Office of Water Peculations and Standards' Effluent Guideline on the Orqanic, Plastic and Synthetic Fibers Industry-. The information that OTS proviripd or developed included 1^50 data, hiocohcentration-, half-lifp in water, cancer risk values, and otHpr faf.e and transport values. OTS also, provided Region 7 with-a.ll the information needed to evaluate its need for an information services unit. STATE PROGRAM The exchange of information between States and EPA benefits both. The States benefit by gaining access to chemical information that can help them develop solutions to local toxics problems that may not he addressed hy Federal authorities. EPA benefits hy receiving information (e.g., data on release, exposure, pt.c.) from the States which can help the Agency anticipate and plan solutions ------- to emerging problems. A mutual benefit of information exchanae is the use of similar rlata; this will hopefully lead fo standardizing regulations developed at the .State and. Fedprai levels. To facilitate the exchanae of toxics information and technical expprtise between State and Federal officials, a forum was provided throuqh a grant with the National Governors' Association (NGA), which sponsors conferences and workshops of this nature. FY 1986 conference topics included: Chemical Safety and. Emergency Preparedness; Indoor Air Pollution: Total Exposure to Toxics; and a workshop entitled Designing a Risk Assessment Office. In addition, the NfiA grant provides- an information clearinghouse and ripvelnps "how-tri" memoranda, issue briefs, and conference proceedings. Additional meetings with Strate officia-ls' have~ taken place with representatives of key States includinn California, Michigan, North Carolina, Maryland, South Carolina, Virninia, Kentucky, New Jersey, Minnesota, and Illinois. These meetinos have had two main purposes: to determine common areas of concprn in the toxics mananement area; and to promote the exchange of risk information, health and safety data, the availability of on-line data assistancp, and thp exchange of information regardina ongoing studies of specific chemicals. The target audiences for such briefings include staff of State environmental (natural resources), public health and agricultural departments. ------- MINET In another effort to inform States of TSCA information and activities, OTS has joined a telecommunication*; network, the Medical Information Network (MINET) which has 43 State health departments online. In FY 198fi, OTS sponsored 13 Statp environmental departments to enable them to sinn on to the system as well. MINET notifies States of key Federal Register notices; of new assessments and health data; of the availability of Chemical Hazard Information Profiles (CHTPs) documents; of regulatory aqenda; and of conferences, meetings, and seminars. Through MINET, States may request information on specific chemicals that are related to their own State activities. ------- 7. COMPLIANCE AND ENFORCEMENT EPA has developed specific strategies to enforce regulations under TSCA. These strategies identify and rank possible violations, identify the available tools for compliance monitoring, specify how these tools are to be used, and provide a formula to determine the applications of inspection resources. Where inspections uncover violations of TSCA requirements, EPA levies civil penalties, as authorized by section 16 of TSCA. PROGRAM ACTIONS During FY 1986, EPA developed and issued compliance monitoring strategies for the Asbestos Abatement. Projects Rule and.the PCB Transformer Fires Rule. EPA also developed and issued an Amendment to the Revised Asbestos-In-Schools Enforcement Response Policy, and.Interim Final Amendments to the Enforcement Response Policy for TSCA section 13 (imports) and TSCA section 8(a) (reporting rules).. EPA continued cooperative enforcement programs to monitor compliance with the PCB regulations in the States of Connecticut, Florida, Maryland, Michigan, New Hampshire, North Dakota, Ohio and Texas; and cooperative enforcement agreements to monitor compliance with Asbestos-In-Schools regulations in.the States of Arizona, California, Colorado, Idaho, Iowa, Maryland, New Hampshire, Oklahoma, Texas, West Virginia and Wisconsin. In FY 1986, the States conducted 732 PCB compliance inspections and 877 Asbestos-In-Schools compliance inspections. 74 ------- COMPLIANCE ACTIONS The California and Idaho Ashestos-In-Schools cooperative enforce- ment agreement programs were completed in FY 198*. For the .States of California, Kansas, Puerto Rico and Washington, PCP cooperative enforcement agreement programs were initiated late in FY 1986. In FY 1986, EPA conducted a hroad range of insppctions for TSCA reguirements. FY 1986 was the first year in which FPA conducted asbestos worker protection inspections. Fifty-five of these types of inspections were carried out. The FPA, alono with piqht State agencies cooperatina under the terms of enforcement grant.s- in-aid, conducted ?,371 PCP compliance monitorina inspections. In addition, the Agency, operatinq under a cooperative agreement with the American Association of Retired °ersons and fhp Statps of Arizona, California, Colorado, Idaho, Iowa, Maryland, New Hampshire, Oklahoma, Texas, West Virginia and Wisconsin, conducted 3,?7n Ashestos-in-Schools inspections. During FY 1986, the Agency also monitoring compliance with TSCA section 4, 5, 8, and 13 reguirements. FPA inspected 1.6 laboratories conducting testing under TSCA to determine if the laboratories were in compliance with Good Laboratory Practice (GLP) reguirements. During these inspections FPA conducted 65 audits of health and environmental tests to determine if testing had been conducted according to test protocols, and if reoorts accurately reflected study findings. EPA also conducted over 75 ------- CIVIL ENFORCEMENT ACTIONS inspections to determine compliance wifh section R and 8 require- ments. The Agency conducted a total of 1,005 inspections to determine compliance with section 13 chemical import requirements. Again in FY 1986, the number of administrative complaints issued by the Regions increased over those issued in FY 1Q85. A total of 781' administrative complaints were issued in FY 1Q86 compared to 733 in FY 1985. For allege^ failure to comply with the import certification requirements (section 13), the Aaency issued ?3 civil administrative-complaint's.. The Aqency also issued-APS civil administrative complaints for alleged violations of the section fi asbestos-in-schools requirements and 3?3 administrative complaints as* a result of PCR inspections... Tn addition, FPA--issued .? civil complaints, for a-lleaed violations'of section s(a), and R civil complaints' for alleged violations of section 5. Hqures for each EPA Regional Office and Headquarters appear in Table 5. The following are case summaries of sianificant TSP.A.civil administrative and judicial cases concluded during FY 1Q86. United States vs. Southeastern Pennsylvania Transit Authority (Civil Action 86-1094 E.D. Pa) - Paoli, Pennsylvania. This TSCA section 7 emergency action, filed jointly as part of CERCI.A and RCRA action, is addressing the imminent hazard to health and the environment posed by massive PC8 contamination at the Paoli Railyard near Philadelphia. The Paoli Railyard serves as the major northeast junction and repair terminal for commuter trains 76 ------- owned and operated by Septa, Amtralc and Conrail, the joint defendants. The civil action souqht. the cleanup of all PCR and PCB-related toxic substances at the Paoli Railyard and the surrounding area. Extensive contamination of adjacent residential areas is being addressed on an emergency basis by an EPA-constructed surface runoff containment system, and by related removal actions. Union Carbide Corporation (Docket No. TSrA-flS-H-n?) - nanhury, Connecticut. This administrative penally enforcement action charged Union Carbide with the failure to provide to the Agency substantial risk information, namely, a cancer study on diethyl sulfate, as required by section 3(e) of TSCA. Following a ypar of administrative litigation, the innovative settlement agreement,- which i* oresently before the Judicial Officer for approval, requires a comprehensive environmental audit of the comoany's risk information and provides for a novel alternative dispute resolution (Anp) procedure, the first such use of ADR in an FPA enforcement action. BASF Systems Corporation fPocket No. TSCA-85-H-nd) - PedfnrH, Massachusetts. In this action, BASF voluntarily disclosed that- it imported and used chemical substances that had not been listed on the TSCA Chemical Substances Inventory, which constitutes a violation of the section 5 premanufacture notification requirements of TSCA. In the settlement of the subsequent enforcement action, RASF aoreed to pay a fine of $80,000 and to initiate a comprehensive environmental compliance audit of its operations at- Bedford, Massachusetts. BASF is required to report any violations discovered in the course of the 77 ------- audit to EPA within 15 days- of discovery, and pay a minimum penalty of $10,000 for each chemical violation reported for chemicals that do not represent a threat to health or the environment. For other chemicals, E°A is free to seek the maximum civil penalty. In addition to these terms, RASF agreed to conduct an evaluation of the TSCA compliance program of its parent corporation, PASF, A.R., of West Germany. United States vs. Commonwealth Edison (Civil Action P4-C-1.507, N.D. IL) - Chicaao, Illinois. Thp Consent Pecree in this enforcement action, signed in FY 1986, resolves FPA charoes that Commonwealth Edison was not properly decontaminating spilled PCBs from pole-mounted electrical capacitors-, which resulted in residual contamination as high as.^.fiOD - 33,-5nn pnm. The company agreed to conduct soil samplina and analysis for thp presence of PCBs at an pstimated' Son spill' sifes in Northern Illinois, and will decontaminate to an FPA approved level an additional estimated 3^0 spill sites. As part of this settlement, Commonwealth Edison is also scheduled to remove all pole-mounted capacitors by January 19*7. DuPont Corporation (Pocket No. TSCA-8fi-H-01 ) _ Wilmington, Delaware. In this action, DuPont was charged with violations of TSCA section 5 premanufacture notification requirements for new substances and paid a ^100,000 civil penalty. Under the terms of settlement, DuPont 's Finishes and Fabricated Products Department, the Division involved in this action, 78 ------- is required to formalize a series of TSCA section 5 compliance assurance procedures. These procedures were compiled into a guidance manual for employees affected by TSCA requirements. The manual has been distributed at plants and laboratories throughout the country. Training programs, with respect to the compliance procedures, have been held at many of DuPont's- facilities. The settlement required DuPont to produce a broadcast quality videotape on the requirements of TSCA, to be used as part of the company's employee education program on TSCA compliance. In addition, DuPont is developing an "artificial input" system to monitor TSCA compliance. .Under this program, test inputs will be designed to test the company's ability to recognize and prevent the unlawful manufacturing or importation of new. chemical- substances that are not on the TSCA Inventory, and the release of new products containing components that are not on the Inventory.' Results of these tests will be reported to'EPA. 79 ------- Table 5 Administrative Civil Actions Taken under section 16 of TSCA, Complaints Issued, Cases Completed, and Amounts Assessed (by Region)* Region 1 2 3 4 5 6 7 3 9 10 HQ TOTAL Total No. Complaints Issued FY' 79-86 110 350 193 184 '615 221 261 215 149 171 29 2,498 No. Complaints Issued FY'86 31 110 61 34 162 63 76 85 64 89 6 781 1 Total No. Cases Completed FY1 79-86 59 218 119 137 419 126 133 122' 92 53" 19 ,497 No. Cases Completed In FY'86** 18 62 25 23 105 22 13 43 40. 10 2 363 1 Total No. of Cases Pending 51 132 74 47 196 95 128 93 57 118 10 ,001 Total Civil Penalties Collected ($) in FY'86 133,504 632,030 262,670 37,855 802", 490 191. ,.780 122,380 60,000 191,330 288,955 160,000 2,882,994 Total Penalties (In $) Collectec FY'79-86 483,735 2,405,815 803,805 429,527 5', 236, .879 1,536,245 511,035 461,515 692,455 438,095 1,954,750 14,953,856 * All actions taken involved alleged violations of TSCA sections 4,5,6,8, and/or 13. ** Includes cases carried over from FY 1980 - FY 1985. 80 ------- 8. LITIGATION ENVIRONMENTAL DEFENSE FUND, INC. v. ENVIRONMENTAL PROTECTION AGENCY (No. 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 polychlori- nated 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. As a result of the Court':; orders in this case, EPA has issued three additional PCB rules. In August 1982, EPA issued a regulation affecting the use of PCBs in electrical equipment; in October 1982, the Agency issued a rule providing an exclusion from the'Statutory ban for PCBs produced in closed manufacturing processes or.discharged into wastes that are disposed of in an acceptable manner; finally, in July 1984, EPA issued a regulation affecting other PCBs inadvertently generated in chemical manufacturing processes. These rules, in turn, have generated other litigation and other regulation. Litigation developments for FY 1986 are described below. August 1982 electrical equipment rule. Previous TSCA Annual Reports described the litigation and subsequent additional rules resulting from the August 1982 rule. One of the additional rules, issued in July 1985, placed additional restrictions and conditions on the use of PCB transformers. The July 1985 rule generated another lawsuit — MISSISSIPPI POUER COMPANY v. EPA (No- 85-4498, 81 ------- 5th Cir.). No further action has been taken in this case in FY 1986 pending the outcome of settlement negotiations. October 12, 1982, closed manufacturing processes rule. The Chemical Manufacturers Association (CMA) filed a petition for review of this rule in December 1982 — CMA v. EPA (No. 82-2518, D.C. Cir.). This suit was rendered moot as a result of developments in the suit. on the July 1984 rule, discussed below. In August 1986, the Court approved a joint motion to dismiss. July 1984, inadvertent generation rule. In late September 1984, petitions, for-review of the July. 1984 rule were filed by the-American Die Casting Institute and Outboard Marine Corporation in the Seventh Circuit, and by the American Paper Institute and Fort Howard Paper Company in the D.C. Circuit., The Seventh Circuit petition was transferred to the D.C., Circutt where the Court consolidated all cases — AMERICAN PAPER INSTITUTE v. EPA (No. 84-1481, D.C. Cir.) and CONSOLIDATED CASES. The Chemical Manufacturers Association was granted permission to intervene. A Settlement Agreement was filed with the Court in August 1986 by most of the parties. Fort Howard Paper Company opposed the Agreement. EPA has agreed to propose and obtain public comment on amendments to the rule that may allow certain activities involving existing stocks of very low level PCB products and materials. EPA also agreed to make a final decision on the proposal within specified time frames. The other settling parties agreed to dismiss the case if EPA issues a final rule substantially similar to the proposed ------- amendments. The Court is asked to hold the proceeding in abeyance until the rulemaking is completed. Fort Howard Paper Company requested the Court not to wait for the outcome of the rulemaking but to order EPA to issue a water discharge effluent standard under TSCA for companies recycling paper contaminated with low levels of PCBs. EPA argues that Fort Howard will have the opportunity to raise its issues in the rulemaking proceeding and that the Court should not waste judicial resources by dealing with the issue before EPA has had the opportunity to consider Fort Howard's position. The parties are awaiting the Court's final decision on approval of the Settlement Agreement. N.Q.C... Inc., t/a Noble Oil Company v. Administrator, (No. 85-3175 3rd Cir.) and (No. 85-1650, U.S. Supreme Court) The Circuit Court of Appeals j'ssued'an opinion affirming EPA's assessment against Noble Oil Company of a civil penalty of $40,000" for three separate violations of Agency regulations on disposal, marking and storage of PCBs. Arguments raised by Noble Oil were discussed in last year's Annual Report. Thereupon, Noble Oil sought review in the U.S. Supreme Court, arguing among other things that (1) the PCB regulations were unenforceable because they were invalidated by the D.C. Circuit in 1979 (see ab-ove) and (2) the Administrator's decision was not supported by substantial evidence. The Supreme Court denied review on June 23, 1986. Service Employees International Union (SEIU) v. Ruckelshaus, (No. 84-2790, D.D.C.) SEIU brought this action in September 1984 to require EPA to issue (1) 83 ------- Federal regulations setting standards for determining when an asbestos hazard requiring correction exists in schools and other public and commercial buildings, (2) requirements for abatement activities where such hazards exist, and (3) standards for performing abatement activities, including standards for the protection of persons performing abatement. In early proceedings SEIU asked the Court for a preliminary injunction, arguing that EPA had a mandatory duty to issue such rules based on promises made by the Agency in response to citizens' petitions. Alternatively, SEIU argued that EPA had failed to complete rulemaking actions on asbestos hazards, in a reasonable time- On November 16, 1984, the Court denied the preliminary injunction because. EPA was "actively pursuing: new. approaches for asbestos abatement," and because EPA has-. In place a voluntary/regulatory asbestos program. Further, the Court determined that deference to EPA was appropriate, citing EPA's assurances that it would shortly issue a final decision on the most feasible asbestos regulatory approach. On November 30, 1984, EPA issued a final decision with respect to certain parts of SEIlTs request, stating that it would not issue regulations governing decisions affecting asbestos abatement activities because such decisions are best made at the local level, and the Agency's current program and planned improvements should adequately deal with the problem. EPA, however, continued with rulemaking efforts related to protection of workers conducting abatement activities and protection of building occupants during abatement. 84 ------- Activities in this area are discussed elsewhere in this report. SEIU amended its complaint, asking the Court to reverse EPA's decision not to issue some of the regulations requested, claiming that EPA's program is not adequate to deal with the asbestos hazard in schools and other buildings. By the end of FY 1985, SEIU and EPA had filed written arguments supporting their respective positions. A hearing before the Court on pending motions was held in October 1985. In September 1986, the Court issued an order indicating it intended to hold a new proceeding on SEIU's request. As of the end of FY 1986, the Court had not yet issued an opinion stating its reasons or an order governing further proceedings. Environmental Defense Fund (EOF) and National Wildlife Federation (NWF) v. Thomas, (No. 35-0973, D.D.C.) '':' Plaintiffs brought this action after EPA had denied, in part, their citizens' petition to issue comprehensive regulations under TSCA on certain isomers of the chemicals known as dioxins. These are substances chemically similar in structure to 2,3,7,8-tetrachlorodibenzo- p-dioxin (TCDD) and which, according to plaintiffs, may present risks similar to TCDD. In early 1986, plaintiffs filed a motion requesting the Court to order EPA to initiate rulemaking because the Agency had improperly denied their petition. EPA opposed plaintiffs' request arguing that its denial was in accordance with statutory requirements. The parties are awaiting the Court's decision. 85 ------- Polaroid Corporation v. United States Environmental Protection Agency and William M. Ruckelshaus (No. 84-3134-K, D. Mass.) In October 1984, Polaroid Corporation (Polaroid) challenged EPA's disclosure and handling of information, submitted by Polaroid under TSCA which had been claimed as confidential (confidential business information) under both section 14 of TSCA and EPA's confidentiality regulations in 40 CFR Part 2. Polaroid challenged EPA's making disclosures of such confidential business information to certain EPA contractors and subcontractors, other Federal agencies, and certain arms of Congress and challenged the adequacy of EPA's security and handling of such information. Further, Polaroid alleged that some of EPA's actions violated the settlement of a previous Polaroid suit involving confidentiality issues in 1978 (Polaroid Corp. v. Costle .No. 78-1133S, 0. Mass.). Polaroid .sought declarative and injunctive relief.. Polaroid requested and was granted expedited discovery which focused primarily on EPA's physical handling and security of confidential business information under the procedures in EPA's "TSCA Confidential Business Information Security Manual"" and the related manual "Contractor Requirements for the Control and Security of TSCA Confidential Business Information." In January 1985, Polaroid unsuccessfully sought a temporary restraining order which would have severely constrained EPA's review of certain premanufacture notices submitted by Polaroid under section 5 of TSCA. After further discovery, EPA and Polaroid entered settlement negotiations.which resulted in the District Court's entering a 86 ------- Consent Order. The Consent Order addressed two areas. First, EPA was in the process, separate from this litigation, of making certain refinements of its security procedures for handling and protecting TSCA confidential business information, including revisions of its security manuals. With respect to those refinements, EPA agreed to report to the Court when they were completed. Second, in the course of settlement discussions, EPA and Polaroid identified certain additional refinements which EPA concluded would be worthwhile. The Consent Order committed EPA to making those additional refinements and to reporting to the Court when they were completed. The Court dismissed the case on September 4, 1986, after the last of the requirements of the Consent Order were met. Chemical Manufacturers Association v. Environmental. Protection Agency (No. 84-1569, D.C. Cir.) On November 19, 1984, the Chemical Manufacturers Association (CMA) filed a petition for review of the first significant new use rule EPA promulgated under section 5(a)(2) of TSCA. The rule was promulgated on September 5, 1984 (49 FR 35011) and related to two chemical substances which were the subject of premanufacture notices under section 5 of TSCA. The rule also included general procedural provisions that will be applicable to all significant new use rules. In the course of informal discussions, CMA indicated that it was concerned about some of these procedural provisions. EPA indicated that it was willing to undertake further rulemaking on these provisions which was likely to meet these concerns. Accordingly, CMA agreed to 87 ------- defer briefing until EPA proposed revisions to these procedural provisions. The revisions were proposed on April 22, 1986. CMA and EPA entered into a settlement agreement under which CMA will voluntarily dismiss its action if EPA promulgates revisions substantially similar to those proposed. Further action in this case is stayed pending completion of the rulemaking. Citizens for a Better Environment, et al. v. Lee M. Thomas (No. 85 C 08000, N. 111.) In September 1985, two public interest, groups challenged EPA's decision denying their petition filed in April 1985, pursuant to section 21 of TSCA. The petition had requested EPA to identify business entities in the southeast area of Chicago which were releasing 1.1. named chemical substances into the environment, and. to initiate rulemaking under TSCA section 4(a) to require testing on the chemical substances — including.testing for cumulative and antagonistic effects. EPA denied the petition, in part, on the basis that there are no available test standards for studying cumulative effects of chemical substances. In addition, the denial notice indicated that health effects data were adequate for regulatory assessment. Finally, the notice stated that EPA had already identified 44 businesses in-southeast Chicago which emit pollutants into the air, and that EPA was conducting a variety of environmental investigations in southeast Chicago. The discovery process, wherein each side may request documents and depositions from the other side, has been initiated and may continue until the spring of 1987. ------- Shell Chemical Co. v. EPA (No. 86-4161, 5th Cir.) and Shell Chemical Co. v. Thomas (No. 86-2671, D.D.C.). On January 7, 1986, four manufacturers of mesityl oxide and the Chemical Manufacturers Association filed in the Court of Appeals a petition for judicial review of EPA's final rule requiring health effects testing of mesityl oxide (Shell v. EPA). The rule was published in the December 30, 1985 Federal Register (50 FR 51857). The proceeding was held in abeyance pending EPA's consideration of the manufacturers' petition under section 21 of TSCA to withdraw the test rule. EPA denied the petition on August 21, 1986 (51 FR 30216). The manufacturers have informed the Court that they will reinstitute the lawsuit. The four manufacturers have also filed an action in District Court, on September 26, 1986, challenging the denial of their section 21 petition (Shell v. Thomas). Th-is District Court action may be stayed pending the outcome of the reinstituted lawsuit in the Court of Appeals. Jack Pierce, d/b/a Jack Pierce Waste-Oil. Inc. v. EPA (No. 86-1486, 7th Cir.): Jack Pierce seeks review of a $29,000 penalty assessed by EPA for violation of the Agency's PCB disposal regulations. Pierce challenges EPA's determination that he owned the tanks from which PCBs spilled and the legal conclusion that he could be held personally liable for a violation alleged to be caused by his business. The case is being held in abeyance pending the outcome of settlement negotiations. New Orleans Public Service. Inc. v. EPA (No. 86-4577, 5th Cir.) New Orleans Public Service, Inc. seeks review of a penalty assessed 89 ------- by EPA for improper disposal of PCB-contaminated transformers. The administrative record of the penalty proceeding before EPA has been filed with the court. Briefs containing legal arguments are expected to be filed shortly. U.S. v. Cannelton Industries, Inc. (No. 83-2406, S.D.W.Va) and CONSOLIDATED CASES. This group of three cases resulted from a spill of PCBs from a transformer in an underground mine operated by Cannelton. EPA filed a complaint alleging Cannelton violated the Agency's regulations regarding disposal of PCBs. Cannelton filed two suits against EPA. One suit requested that the court declare Cannelton's rights and resppnsibilites with respect to storage and disposal of PCBs in its mine. In the second sui.t, Cannelton requested- the Court to order EPA to .initiate a'proceeding .to amend .its PCB disposal rules. EPA and Cannelton reached an agreement on cleanup of the. PCBs, which was approved by the Court in February 1986. The court has retained supervisory jurisdiction over the agreement. Two suits were filed against EPA regarding the Agency's consideration of whether to allow a PCB disposal facility in Henderson, Kentucky. Michael D. Vanderveer and City of Evansville, Indiana v. EPA and Unison Transformer Services. Inc. (No. EV86-183C, D.C.Ind.) Plaintiffs requested a preliminary injunction to prevent a trial demonstration, approved by EPA, of Unison's PCB disposal process. The process chemically separates PCBs from transformer fluid. The PCBs are then shipped to other facilities where permanent disposal takes place. 90 ------- In support of the preliminary injunction plaintiffs argued that the City of Henderson, Kentucky had failed to comply with.its procedures for issuing zoning permits before the trial demonstration was authorized. The Court denied the preliminary injunction on September 11, 1986, stating that the citizens did have an adequate opportunity to present their views before the zoning authority. Plaintiffs also requested a permanent injunction against operation of the facility, stating in their complaint that EPA needs to consider criteria applicable under the Resource Conservation and Recovery Act (RCRA) in addition to criteria under TSCA when approving the Unison facility and that the operation of the facility would present an unreasonable risk of harm to plaintiffs. Further proceedings on the permanent injunction are expected during FY 1987. Citizens for Healthy Progress, Inc. v. EPA (No. 86-0155, D.C. Kentucky] Plaintiffs in this suit, filed on September 18, 1986, are requesting temporary and permanent injunctions to prevent EPA from allowing operation of the Unison facility. The Complaint states that the permit for the facility should only be granted after consideration of RCRA criteria, not criteria under TSCA, and that they are unable to evaluate the risks caused by the facility because EPA and Unison have not disclosed the identity of the chemical used to separate PCBs. Further proceedings are expected in this case in FY 1987. 91 ------- 9. INTERNATIONAL ACTIVITIES Since" the passage of TSCA, EPA has been involved in a number of international activities to promote coordinated approaches to evaluating and managing toxic substances. The Agency considers these programs of critical importance, and continued to play a very active role during FY 1986. EPA's i-nternational activities include the exchange of information and expertise, which provides significant benefits to several international organizations. One of its most visible and successful international efforts is its participation in the Chemicals Group and Management Committee. of the Organization for Economic Cooperation and Development (OECD). The OECD, a 24-member international organization comprised of the world's major industrialized nations, was founded both to. promote the development of, and. to prevent barriers to,. international trade. .Due to a proliferation of national chemical laws during the. 1970s, the-OECD membership recognized the potential for chemical trade barriers. It therefore established a program in 1977 to develop harmonized approaches to the review, evaluation and management of toxic substances. During FY 1986,. EPA continued to build on several important initiatives and, through continuing preparations for a third meeting of the Chemicals Group at High Level (HLM III), to define a framework for Chemicals Group and Management Committee activities into the next decade. Three early efforts in the Chemicals Program involved hazard assessment, good laboratory practice and confidentiality of data; important followup work was also initiated in 1985. During 1986, 92 ------- significant progress was made in each of these important areas. Responding to previous recommendations of hazard assessment experts that the initial work in this complex area should focus on exposure assessment, a Workshop on Practical Approaches to the Assessment of Environmental Exposure convened in Vienna, Austria, in April 1986. The Workshop produced reports summarizing the technical methodologies Member countries use for conducting environmental exposure assessments in three areas Source Characterization, Fate and Pathways, and Targets of Exposure. U.S. experts were generally pleased with the outcome. Further work on hazard assessment will be developed and undertaken under the supervision of the newly established Hazard Assessment Panel, which the U.S. chairs.. With regard to Good Laboratory Practice, GLP experts met twice during 1986 and. reached agreement on two basic'documents: the Guide for Compliance Monitoring Procedures for Good Laboratory Practice and Guidance for the Conduct of Inspection and Study Audits. Although the group agreed that it had completed its major tasks and should not continue after May 1987, it also recognized that GLP experts should continue to meet periodically to exchange information and experiences in GLP implementation. An expert group on confidentiality met twice during 1986 to continue efforts to develop a model form for agreements for the exchange of confidential information. After initial difficulties, this group has succeeded in producing a model form for bilateral agreements, as well as guidance for countries negotiating such 93 ------- agreements that is designed to highlight important issues for consideration during negotiations. In the area of existing chemicals, the pilot phase of the Chemical Information Switchboard, which began with six countries (including the U.S.) during 1985, continued operations during 1986 to increase Member state access to unpublished information on chemicals. Early in the year, agreement was reached with other pilot members to increase the number of allowable requests from two to four per month, since the Switchboard seemed able to accommodate such an information exchange. An evaluation of the usefulness of the Switchboard will be initiated late in 1986 and a determination made concerning the expansion of the. Pilot to all OECD Member states. Increasingly, EPA's attention and efforts have focused on preparations for the third meeting of the Chemicals Group at High Level (called HIM). These HLMs occur periodically to review work in the Chemicals Program and, more importantly, to give guidance for the nature and direction of future work. A special Steering Group to prepare for HIM III met three times in 1986 to discuss HIM documents on: past Chemicals Program achievements, Chemicals Safety Testing and the Use of Animals, Cooperation on Existing Chemicals Investigation, Chemicals Risk Management, and the Future of the Chemicals Program. The Ongoing Chemicals Program activities that are important to OTS are the Test Guidelines Updating Panel and the Complementary 94 ------- Information Exchange Procedure. During the past year, four new guidelines in genetic toxicology were adopted by the OECD Council. The Updating Panel endorsed revisions to three acute toxicity guidelines, primarily as a result of ongoing a.nd increasing concern for animal welfare. This concern was apparent at two meetings during 1986, an experts meeting in April on acute toxicity testing, and a Seminar on Chemicals Testing hosted by the government of Sweden in May. The Complementary Information Exchange Procedure was established in 1978 to provide Member states early notice of regulatory plans or actions. The U.S. has historically sent more information through this system than other Member countries. .However, as more and more countries have legislation or regulatory action to report, the system is' being used to- an increasing degree.. EPA also participates in several programs of the United Nations, such as the United Nations Environmental Program (UNEP) International Register of Potentially Toxic Chemicals (IRPTC) and the World Health Organization (WHO) International Program on Chemical Safety (IPCS). The basic objective of the IRPTC is to promote more efficient use of national and international resources in the evaluation of chemicals. EPA supports IRPTC by providing scientific and regulatory information on chemicals, and by responding to chemical inquiries relayed through IRPTC headquarters in Geneva. In 1986, the IRPTC assumed responsibility for compiling regulatory information on chemicals slated for inclusion on the U.N.'s Consolidated List of Banned, Withdrawn or Severely Restricted Products. 95 ------- A UNEP group of experts continued work during 1986 on the development of guidelines for the exchange of information related to banned .or severely restricted chemicals in international trade. An information exchange scheme on such chemicals, which closely resembles EPA's existing export notification procedures has been in operation on a provisional basis since 1984. The experts will meet to finalize the guidelines in February 1987. The IPCS was established in response to the need for a collaborative international approach to evaluate the effects of chemicals on- health and' the environment. Member state experts work within the .IPCS to develop assessment documents on chemicals,. set exposure guidelines, coordinate testing when appropriate, and promote technical cooperation and. training., OTS has been the-1 lead- in preparing'the IPCS assessment document on gly.c"ol ethers and- also will be preparing such documents for nitrobenzene, 2-nitro- propane, chloroparaffins and methyl ethyl ketone. In response to . the Bhopal tragedy, IPCS launched an effort to promote international chemical safety. The first steps of this effort include projects on reactive intermediates, and the identification of national emergency response mechanisms and reported incidents. 96 ------- 10. RESEARCH AND DEVELOPMENT ACTIVITIES Toxic substances research provides support to meet the current and future needs of the Toxic Substances Control Act. Research efforts are geared toward providing scientifically valid yet cost- effective evaluations of the risks associated with the manufacture and use of new and existing chemicals. The research program in support of TSCA develops, evaluates, and validates health and environmental test methodologies and procedures to improve the predictability of human risk estimates and to develop exposure monitoring systems, environmental fate and effects methods, and develops guidelines to perform environmental risk assessments. Additional research develops and evaluates release and control methods for new and existing chemicals, structure- activity relationships as predictors of chemical fate and/biological effects, and procedures for ensuring the human and environmental safety of the products of biotechnology. MAJOR RESEARCH ISSUES Test Method Development Under TSCA, manufacturers must test chemicals for potential hazards to human health and the environment. Consequently, research is conducted to provide guidance for performing such tests,. Regulatory decisions on a chemical depend on qualitative and quantitative scientific data from industry regarding the potential adverse environmental and human health effects of 97 ------- exposure to the chemical. Sensitive, reliable, cost- and time- effective tests are needed; therefore, the Agency is developing and approving carefully screened methods. Such methods will he incorporated into testing guidelines for use by industry and others who must evaluate the safety of chemicals. Structure Activity .Relationships (SAR) To enhance the efficiency of the regulatory process for toxic chemicals, EPA groups various chemicals which share common or similar chemical characteristics instead of dealing separately with each individual chemical. If it can he demonstrated that chemical relationships, such as similar molecular structures and simiTar modes of toxic activity, form a-firm scientific basis for estimating probable environmental risks, then better guide- lines and techniques can be applied and regulatory actions can he completed more quickly using less resources. The SAR approach is vital for reviewing and screening new chemical substances under section 5 of TSCA. The findings and techniques established in this research are used to select appropriate toxicity tests, to document test results, to develop fate and effects data bases where necessary and to provide the modeling means to predict toxicity. Special Human Data Needs To improve the Agency's ability to estimate human risk, these activities examine population groups exposed to environmental contaminants which are suspect toxicants to determine if biological 98 ------- indicators of Hose and/or effects are related to environmental levels of exposure. Data are also being developed on adverse effects as measured hy traditional eoidemiological studies. Ecology: Transport/Fate/Field Validation To adequately evaluate the likely perturbations a toxic chemical may cause in the environment, it is necesary to understand probable exposure concentrations and durations, movements through ecosystems, degradation rates, reservoirs, effects and residues. The Agency must have available techniques which may be applied to attain this information, must be caoable / of interpreting findings and must have a predictive capacity ^o anticipate problems. Activities in this area are desinnpd to mpet t.hpse needs, to improve the criteria and standards with which industry, the user?;, nr the Agency must comply. Thp int.pnt is to provide new or improved state-of-the-art technigues to fill data gaps in order to take regulatory actions that are both scientifically credible, and legally defensible. Health: Markers, Dosimetry, and Extrapolation Health effects research, is focused on development of methodol- ogies for the extrapolation of data from high to low doses and between mammalian species, to enhance human health risk assessment predictability. Additional studies in the toxic substances research program involve defining the relationship between biologic markers of exposure and non-cancer health endpoints such as neurotoxicity and immunotoxicity as well as genotoxic endpoints. Posimetry 99 ------- studies are examining dermal and inhalation routes of exposure. Extrapolation research has a larae pffort dpvoted to gpnpt.ically mediated health effects. Exposure Monitoring The major TSCA-related monitoring research efforts are currently directed toward improving the monitoring systems designed to estimate total human exposure. Research is also .continuing on approaches for multi-media/multi-pathway monitoring systems which generate-data that will provide an estimate of total human exposure. Epa is also conducting studips to incorporatp environmental dose into personal exposure monitors to provide a better understanding of the contribution-of diffprent pxposure • routes to pollutant intake. The relationship of network monitoring to personal exposure monitoring will be eyalua-ted in-a Human Exposure'Assessment- Location Proipct., Biotechnology/Microhial and Biochpmical Ppst Control Agents Users of hiotechnological products must follow recommendpd Agency guidelines in a Besting regime designed to help prevent. adverse environmental impacts. EPA's Office of Research and Development (ORn) helps establish these technigues, determines if environmental effects are exhibited by previously untested non- target organisms, and conducts field-oriented validation studies as necessary to ensure that testing criteria and guidelines are appropriate and functional. Engineering research is also underway • to develop and/or improve methods to contain or destroy genetically engineered organisms. inn ------- Under TSCA, efforts focus on developing scientific rationales and procedures for evaluating the environmental survivability, reproduction, distribution, effects and risk associated with the escape of genetically manipulated organisms. The results will be used to prepare protocols for use in evaluating TSCA products involving environmental application of microbes. This research wi.ll also support regulatory rulemaking by specifying which products are to be considered under TSCA. In the health research area, studies are being conducted to determine the genetic stability and function of a baculovirus expression vector in vertebrate cells. Methods are also being developed to evaluate the potential health consequences of deliberate or inadvertent release of genetically altered organisms. Engineering Release and Controls Under section 5, manufacturers are required to submit information to EPA on both the release and control of new chemical substances, and on significant new uses of designated existing substances. EPA uses existing data to predict the risk.s from the release of new substances, and under the existing chemicals control program, evaluates technological alternatives to reduce the release of and exposure to chemicals that are already in use. Models are being developed which predict release of and exposure to classes of new substances, in order to assess chemical - unit operations and processes, and the physical and chemical 101 ------- properties of chemical substances. Models to predict potential exposure and release levels, as well as the best control measures to control release of and exposure to new substances are also being developed. Treatability testing of potentially toxic chemical.s is also being conducted. Alternatives devised to mitigate the release of and exposure to specific existing and pew toxic substances are being defined, through the evaluation and adaptation of control measures related to the release of chemicals in the workplace and into the environ- ment. EPA is also evaluating technologies, management, practices, and personal protective equipment.to limit exposure to those toxic substances and their release into the environment. Ecology: .Ecotoxicity and Risk Assessment. In the. past, the emphasis of ORD's scientific assessment program has been on the assessment of risk to human populations. However, there is also a need to assess the risk to non-human populations and to the environment. The development of ecological risk assessment methodologies for terrestrial and aquatic ecosystems (primarily endangered species and commercial fisheries) is necessary to quantify the probability that adverse effects may occur as a result of exposure to a toxic substance, and to estimate the significance of such effects in the environment. .Since environmental data developed by industry may vary greatly from chemical to chemical, procedures need to be developed which provide guidance and consistency for the various environmental exposure activities. This work will provide risk assessment protocols, guidelines, and a 102 ------- computerized decision support system for the assessment of effects to terrestrial and aquatic ecosystems. This decision support system will provide analysts in OTS with information on specific ecological risks and their long-term consequences to provide the technical foundation for regulations based on probable ecological damage. Support For certain assessments, the technical expertise of the ORD staff is required to conduct literature searches, interpret data or render technical and scientific judgments due to of the lack of data. In cases where program office evaluations are complicated and/or controversial, independent peer review of assessments is required to ensure consistency. There is a continuing need for ORD participation in and review of major.exposure and hazard assessments conducted by OPTS, for supplying Agency policy-makers with technical assistance from qualified scientists, and for improving the scientific basis of Agency decisions in regulatory matters. Finally, in both the pesticides and toxics areas, support will continue for quality assurance, and the maintenance and dissemination of standard reference materials. See Appendix H for a summary of FY 1986 accomplishments. 103 ------- Appendix A Summary/Guide to Information Required hy Congress Sections 30, ?R(c) and 9(d) of TSCA require that, certain information he reported each year to the President and Connress. To assist readers in locating this information, a summary of each pertinent TSCA action and reference to a more detailed explanation found within this report are qiven here: Section 3D, This section contains the basic requirement for the Annual Report as follows: (1) Testing. Tn FY 19fl*, EPA published 17 notices of proposed rulemaking, 10 proposed t»st standards, 9 notices of final rulemaMnq, and 6 decisions not to test (see-Tahlp-4).,. (?) New Chemical Substance Submissions. EPA received ?,?13 new chemical substance notices f"l,fi93 Premanufacture Noticps, Fifi Test Market Exemption Applications, 233 Po'lymer Fxemption Nnticesv and ?31 Low >'.o1ume Exemption Notices]' during EY 1Q86, which brought the "trot a T received since .thp. proaram's heginninq in mid-1979, to-3,511. None-of these substances were subject to rulemaking under section 4. In EY 19Pfi, 3? cases underwent voluntary testing or control activities, while P7 chemicals were subject to the development of either a section fife) or 5(fl order (see Table 1). (3) Rules Issued under Section 6. During FY 19«fi, four rules were published under section 6. One action responded to ?? PCR exemption petitions (NFR); the other three actions were related to asbestos activities (1 ANPR, 1 NPR, 1 NFR) (see Chapter 4, Existinn Chemicals for detailed description of PCB and Asbestos accomplishments). 104 ------- (4). Judicial Actions under T.SCA and Administrative Actions under Section 16. Judicial actions involved PCRs, asbestos, dioxins, significant npw use rules, FPA's testing program under section 4 of TSCA, and section ?1 citizen petitions. Ry far, the greatest amount of litigation was on PCRs. There has hpen extensive litigation on PCR rulemaking resultina from the 1QPO decision invalidating FPA's original PCR' rules. All thp lit.ination involving rule- making suhseguent to the 19PO decision, however, is likely tn he settled. Four PCR cases involved situations .where FPA was enforcing its PCP disposal regulations. Three PCR enforcement related cases were appeals from penalties assessed hy FPA; one was resolved in FPA's favor, two have heen recently filed and are awaiting the setting of a schedule for submitting hripfs. One PCR enforcement-related case (actually a'consolidation of three cases involving the same company) was settled when the defendant and FPA anreed to procedures for cleanup of PCRs. -Two lawsuits have been filed recently against FPA's approval of a PCR disposal facility in Henderson, Kentucky. Three suits are pending attempting to compel FPA to regulate, one with respect to dioxins, one with respect to asbestos, and one to require tpsting of certain chemical substances present in the southpast area of Chicaqo. A petition for rev'iew was filed with respect to the first sianificant new use rule under section 5(a)(?); briefing has been stayed pendinq further rulemaking. A petition for review has been filed challenging one of FPA's rules to require testing under section *(a) Of TSCA. (5) Ma.jor Problems in Administering the Act. No major problems were encountered in FY 19flfi in administering TSCA. 105 ------- (6) Recommended Legislation. Mo leqislative changes are souqht at this time. Section 2fl(c). This section reouires a report on grants to States durino the year. There were no grants administered under TSCA in FY 1QPK. Grants associated with asbestos were administered under the authority of the Asbestos School Hazard Abatement Act (ASHAA) (see Chapter A on Fxistinq Chemicals). Section 9fd).. This section requires that FPA's efforts to coordinate its TSCA activities with related activities of othpr Federal anenries he reported annually. During FY 19Pfi, EPA continued, in several formal and informal agree- ments with- other Federal government proqrams, to address specific chemical activities with respect to. the devplopment and implementation of regulations under TSCA. One of these continued efforts1 is participation in the Federal Asbestos Task Force, of which OSHA, CPSC and FPA are charter mpmbers. Other members include the Food and Drug Administration (FDA), the National Institute of Occupational Safety and Health (NIOSH), the National Institute of Environmental Health Sciences (NIEHS), and the National Cancer Institute (NCI). In FY 1986, the Plan for the Interaqency Pequlatory Investigation of Chlorinated Solvents in four ma.ior exposure cateqories was submitted to the EPA Assistant Administrators and senior manaoement of OSHA, CPSC, and FDA. Representatives of the four agencies met in July 19flfi and essentially approved the Plan. The Plan calls for submission of options to control risks associated with metal cleaning and dry cleaninq in December 19P6, and paint, strippers and aerosols in August 1937. Five chemicals were referred to OSHA for regulatory consideration in lOfi ------- FY 1986. These were: 1,3-butadiene; formaldehyde (apparel manufacturing); glycol ethers; methylene bis (2-chlorobenzenamine) (MBOCA); and toluenediamines. Under an interagency agreement with NIOSH, EPA and NIOSH completed selection of a respiratory strategy for use in PMN review, and developed a final table of assigned respiratory factors. Laboratory work on respiratory protection is nearly complete; NIOSH will begin field studies in FY 1987. In FY 198(5, the article, "Relation of Survival to other Endpoints in Chronic Toxicity Tests with Fish" was published in Environmental Toxicology and Chemistry. This was the result of work accomplished between EPA and the U.S. Fish- and Wildlife Service (FWS). Also under the interagency agreement with FWS, a wildlife toxicity handbook was reprinted. The Agency continued to participate in FY 1986 on the Working Group on Biotechnology, established by the Cabinet Council on National Resources and the Environment. The group discusses major Federal interagency issues on biotechnology and develops a coordinated position on them. Members include: Biotechnology Science Coordinating Committee, the Department of Agriculture, EPA, FDA, NSF and OSHA. A joint policy statement was published in June 1986. Under an interagency agreement, the Department of Health and Human Services/National Institute of Dental Research continued to provide data and information management support for hazard and risk analysis of genetically modified organisms. Through an interagency agreement, the Agency is working with NIOSH to better characterize occupational exposure and environmental release for acrylates/methacrylates used in radiation-cured applications. NIOSH is presently conducting walk-through industrial hygiene surveys to collect 107 ------- data from approximately a dozen facilities that process and use acrylates in radiation-cured coatings, inks, and adhesives. The surveys, along with NIOSH site reports,.are expected to be completed by March 1987. Chemical Advisories are coordinated with other Federal agencies as appropriate. For example,'advanced drafts of the Advisories on 2,4-Toluene- diamines and burning used oil were reviewed by program management and technical experts at OSHA, because of the obvious workplace setting of the hazards covered in these documents. 108 ------- Appendix B Major FY 1986 TSCA Actions Description Section of Law Date 4 Procedures Governing Testing Consent Agreements 06/30/86 and Test Rules under the Toxic Substances Control Act 4(a) For listing of testing decisions see Table 4. 4(b) Test Guidelines Published 01/06/86 -Indirect Photolysis Screening Test 4(f) Methylene Chloride; Initiation of Regulatory 10/17/85 Investigation (Advance Notice of Proposed Rulemaking) 5(a)(2) N,N,N'N'-Tetrakis(oxiranylmethy1)-l,3-cyclo- 01/13/86 hexane dimethanamine (Proposed Significant New Use Rule) Methyl ammonium- n-methyldithiocarbamate (Proposed "03/24/86 Significant New Use Rule) Substituted benzenes, halogenated (Proposed 03/18/86 Significant New Use Rule) (2 chemicals) Certain acrylate chemicals (Proposed Significant 04/04/86 New Use Rule) (4 chemicals) Benzoic acid, 3,3'-methylenebis [6-amino-, di-2- 05/06/86 propenyl ester (Final Significant New Use Rule) Certain alkylsulfonic acids ammonium salts 06/11/86 (Proposed Significant New Use Rule) (2 chemicals) Poly(2-hydroxypropyl)melamine, polymers with 06/25/86 5-isocyanato-l-(isocyanatomethyl)-1,3,3-trimethyl cyclohexane, 2-hydroxyethyl acrylate-blocked (Proposed Significant New Use Rule) Benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl- 07/24/86 4-(trifluoromethyl) (Proposed Significant New Use Rule) 109 ------- 5(e) 1-Propanol, 3-mercapto-(Proposed Significant . 09/12/86 New Use Rule) Hexachloronorbornadiene (Final Significant New 11/19/85 Use Rule on an Existing Chemical) Hexamethylphosphoramide and Urethane (Final 03/19/86 Significant New Use Rule on an Existing Chemical) (2 chemicals) Pentach.loroethane (Proposed Significant New Use 03/24/86 Rule on an Existing Chemical) Methyl ^-butyl ketone (Proposed Significant New 07/07/86 Use Rule on an Existing Chemical) PBBs and Tris (Proposed Significant New Use 07/07/86 Rule on an Existing Chemical) (9 chemicals) 11-Aminoundecanoic acid (Proposed Significant 07/22/86 New Use Rule on an Existing Chemical) Pentachloroethane (Final Significant New Use 09/09/86 Rule on an Existing Chemical) Significant New Use Rules; Proposed Amendments 04/22/86- to General Provisions and Individual Rules (Proposed Rule) Consent Order with Testing Trigger; Substituted 11/20/85 phosphate ester (P85-730) - requires protective equipment to control worker exposure, and ecotoxicity testing. The Consent Order includes a testing trigger for a 90-day subchronic study. Consent Order; Alcohols, Cl-4, ethers with 12/20/85 polyethylene-polypropylene glycol mono(2- aminopropyl)ether, polymer with maleic anhydride and trimethylolpropane triacrylate .(P85-1176) - requires gloves, goggles and protective equipment to control worker exposure pending development of information. Consent Order; Substituted aromatic amide (P84- 12/23/85 1136) - requires use of worker protective equipment, including impervious gloves, safety goggles and protective clothing. Training including warning statements are also required, and MSDS. 110 ------- Consent Order with Testing Trigger; Substituted 12/24/85 aromatic (P84-954) - requires protective equipment to control worker exposure, eco- taxicity testing, and release monitoring. Consent Order includes a testing trigger at which tne Company must submit acute and chronic eco- toxicity data. Consent Order; Isopropylidene-bis-(l,l-dimethyl- . 12/24/85 propyl) derivative (P85-648) - requires protective equipment and labeling to control worker exposure pending development of infor- mation. Consent Order; Polymer of: methacrylate -acid; 01/03/86 succinic anhydride; phenol, 4,4'-(l-methylethyli- dene)bis-polymer with (chloromethyl); 2-methyl- irnidazole (P85-1014) - requires protective equipment to control worker exposure pending development of information. Consent Order; Silicone ester polyacrylate 01/09/86 (P85-296) - requires protective equipment to control worker exposure pending development of information. Consent Order; Ami no aery late monomer (P85-298) - 01/09/86 requires protective equipment to control worker exposure pending development of information. Consent Order; Substituted pyridine (P85-36) - 01/17/86 requires protective equipment and engineering measures to control worker exposure pending development of information. Consent Order; Haloalkyl substituted cyclic ether 01/17/86 (P85-367/368) - requires protective equipment to control worker exposure pending development of information. Consent Order; Haloalkyl substituted cyclic ether 01/17/86 (P85-369) - requires protective equipment and respirators to control worker exposure pending development of information. Consent Order; Substituted pyridine (P85-706) - 01/17/86 requires protective equipment to control worker exposure pending development of information. Consent Order; Functionally modified urethane (P85-1063) - requires protective equipment to 01/17/86 control worker exposure pending development of information. Ill ------- Consent Order; Polyester polyurethane 01/17/86 (P85-1068) - requires protective equipment to control worker exposure pending development of information. Consent Order with Testing Trigger; Disubstituted 01/24/86 alkyltriazine (P85-932/933) - requires protective equipment and respirators to control worker exposure. The Consent Order includes a testing trigger for a 28-day oral subchronic study. Consent Order; Cycloaliphatic epoxide 01/30/86 (P84-1137) - requires protective equipment to control worker exposure pending development of information. Consent Order; 1,1-Oimethylpropyl peroxyester 01/31/86 (P85-680) - requires protective equipment to control worker exposure pending development of information. Consent Order with Testing Trigger; Polypropylene 02/10/86 glycol alkyl ether (P85-390/891/892) - requires protective clothing to control worker exposure. The Consent Order includes a testing trig-ger for a .90-day subchronic study.. Consent Order; Kel acrylate complex (P85-1XJ34) - 02./13/86 requires gloves to control worker exposure- pending development of information. Consent Order with Testing Trigger; Disubstituted 03/05/86 sulfide (P85-234) - requires a production volume trigger, at which the Company must submit 28-day subchronic and sister chromatid exchange studies. Consent Order; Ester-modified epoxy resin 03/06/86 (P85-1380) - requires protective clothing to control worker exposure pending development of information. Consent Order; Halogenated alkene (P85-1167) - 03/07/86 requires protective equipment and respirators to control worker exposure pending develop- ment of information. 112 ------- Consent Order with Testing Trigger; Polymer of 03/17/86 an aerylate ester and mixed methacrylate esters (P85-1283) - requires protective equipment to control worker exposure. The Consent Order includes a testing trigger for a 90-day oral subchronic study. Consent Order; Omega-functional esterified hydroxy 03/17/86 methacrylate (P85-1302) - requires protective equip- ment to control worker exposure pending development of information. Consent Order; Functional polyurethane from poly- 03/17/86 alkylene oxide, aliphatic diisocyanate and substituted alkanol (P85-1318) - requires protective equipment to control worker exposure pending development of information. Consent Order; Substituted amino anthraquinones 03/20/86 (P85-18) - requires protective equipment to control worker "exposure pending development of information. Consent Order; Capralactone modified by 03/25/86 hydroxyethyl methacrylate (P86-164) - requires protective clothing to control worker exposure pending development of information. Consent Order; Aliphatic diurethane acrylate 04/01/86 ester (P85-1013) - requires protective equipment, clothing, and respirators to control worker exposure pending development of information. Consent Order; Unsaturated acid and heterocyclic 04/01/86 modified epoxy resin (P85-1425) - requires protective equipment, clothing, and respirators to control worker exposure pending development of information. Consent Order with Testing Trigger; Benzoic acid, 04/03/86 2-((3A,4,5,6,7,7A-hexahydro-5(or 6) methoxy- 4,7-methanoindan)-methyidene)amino, methyl ester (P85-1210) - requires a production volume trigger at which time the Company must submit acute ecotoxicity studies. Consent Order with Testing Trigger, Benzoic acid, 04/03/86 2-(3-phenyl,butylidene)amino, methyl ester (P85- 1211) - requires a production vo.lume trigger at which time the Company must submit acute toxicity studies. 113 ------- Consent Order with Testing Trigger; Benzoic acid, 04/03/86 2-(3-(4-methyl,cyc1ohex-3-enyl)butylidene)amino, methyl ester (P85-1212) - requires a production volume trigger at which time the Company must submit acute toxicity studies. Consent Order; Substituted alky! alkanol (P85- 04/05/86 822) - requires protective equipment to control worker exposure pending development of information. Consent Order; Substituted pyridine (P84-1219.) - 04/09/86 requires protective clothing respirators and gloves to control worker exposure pending development of information. Consent Order; 3-Chloro-2,6-dinitro-N,N-dipropyl- 04/09/86 4-(trifluoromethyl)-benzenamine (P86-83) - requires protective equipment and clothing to control worker exposure pending development of information. Consent Order;- Acid modified acrylated epoxide 04/11/86- (P85-1169) - requires gloves, goggles, protective clothing, and respirators to control worker exposure pending development of information. Consent Order; Acid modified acrylated ha-logenated 04/11/86 epoxide (P85-1170) - requires gloves, goggles, protective clothing, and respirators, to control worker exposure pending development of information. Consent Order with Testing Trigger; Sodium salt 04/28/.86 of an alkylated, sulfonated aromatic (P84-591) - requires a production volume trigger, at which time the Company must submit chronic ecotoxicity testing. Consent Order; Tert-amyl peroxy alkylene ester 05/23/86 (P85-1180) - requires protective clothing and gloves to control worker exposure pending development of information. Consent Order; Polymeric aliphatic polyol 06/05/86 acrylate ester (P85-159/160/161/162) - requires gloves, goggles, protective clothing, and res- pirators to control worker exposure pending development of information. Consent Order; Substituted acrylated alkoxylated 06/09/86 aliphatic polyol (P86-346) - requires protective equipment to control worker exposure pending development of information. 114 ------- Consent Order; Substituted alkyl aniline (P85- 06/13/86 1420) - requires protective equipment, clothing, and respirators to control worker exposure pending development of information. Consent Order; Substituted pyridine (P85-236) - 06/15/86 requires protective equipment, clothing, and respirators to control worker exposure pending development of information. Consent Order with Testing Trigger; 1-Propanol, 06/16/86 3-mercapto- (P85-433) - requires protective equipment, clothing, and respirators to control worker exposure. The Consent Order includes a testing trigger for a developmental toxicity study. Consent Order with Testing Trigger; Ethenyl silane 07/11/86 ester (P85-1369) - requires 90-day subchronic test after reaching specified aggregate production volume. Consent Order; Modified acrylic ester (P86-387) - 07/11/86 requires worker protective clothing and use of a NIOSH-approved respirator, plus warning statements and MSDS. Consent Order; N-Nitrosophenylhydroxylamine, 07/24/86 ethanolamine salt (P86-542) - requires worker protective clothing, warning statements and MSDS. Consent Order with Testing Trigger; Benzothiazole- 08/12/86 sulfonic acid, substituted-((substituted-pyrimidinyl) azo)carbamonocycle-, alkali metal salt (P85-994) - requires use of worker protective equipment during manufacturing and processing. Consent Order with Testing Trigger; Alkyl(hetero- cyclicylJphenylazo-heteromonocyclicpolyone (85- 1370) - requires standard development toxicity test in two mammalian species after reaching aggregate combined production volume of the PMN substance. Consent Order with Testing Trigger; Alkyl unsub- stituted spiro heterocyclic (P86-136) - requires use of worker protective equipment during manufacturing and processing. 08/12/86 08/12/86 Consent Order with Testing Trigger; Triglycidyl ether of substituted tri(hydroxyphenylJmethane (P85-854/855) - requires 90-day subchronic test one species after reaching specified production volume. 08/15/86 in 115 ------- Consent Order with Testing Trigger; Triglycidyl ether 08/15/86 of a substituted tri(hydroxyphenyl) methane (P85-973) - requires 90-day subchronic test in one species after reaching specified production volume. Consent Order with Testing Trigger; Modified tris- 08/15/86 phenol epoxy novolac (P86-382) - requires use of worker protective equipment, including impervious gloves, safety goggles and protective clothing. Training and warning statements are also required, and MSDS. Consent Order with Testing Trigger; 1,3,5-Triazine- 08/19/86 2,4,6(lh,3h,5h)-trione, l,3,5-tris(2,3-dibromo- propyl) (P84-900) - requires worker protective equipment, use of approved respirator, warning, labelling. Production volume trigger requires 2- generation reproduction study. Consent Order with Testing Trigger; Methyltris 08/25/86 (1-methylethyl )benzene (P86"-124) - requi res" two- tiered testing after reaching specified aggregate pro- duction volume. Tier 1 test requirements are acute and chronic aquatic studies. Tier 2 requires 90-day oral subchronic and a fish bioconcentration test. Requires worker protect!v-e equipment, including protective clothing-and respirators; and. restrict.ron of releases to approved sites. • ' . Consent Order; Poly(oxy~l,2-ethaned1yl),alpha(l-oxo- 09/08/86 2-propenyl)omega-(dodecyloxy)- (P86-554) - requires protective equipment, notification, labelling and MSDS. Consent Order; Poly(oxy-l,2-ethanediyl),A-(2-methyl-l- 09/08/86 oxo-2-propenyl)-w-(dodecyloxy)- (P86-588) - requires pro- tective equipment, notification, labelling and MSDS. Consent Order; Methacrylic ester (P86-650) - requires 09/25/86 worker protective equipment, MSDS and labelling. Unilateral Action; vinyl chloride - vinyl acetate 04/22/86 hydroxyl modified copolymer (P85-1388) - bans chemical to control worker exposure. Unable to address health concerns without additional data. 116 ------- 5(h)(3) 6(e) 8(a) 8(b) Revisions of Premanufacture Notification 04/22/86 Regulations (Final Rule) Asbestos; Proposed Mining and Import Restrictions 01/29/86 and Proposed Manufacturing, Importation and Processing Prohibitions (Proposed Rule) Asbestos Abatement Projects (Final Rule) 04/25/86 Asbestos-Containing Materials in Schools; Inspec- 08/12/86 tion, Notification, Management Plans, and Technical Assistance (Advance Notice of Proposed Rulemaking) Response to Exemption Petitions (PCBs) (Final Rule) 08/08/86 Partial Updating of TSCA Inventory Data Base; 06/12/86 Production and Site Reports (Final Rule) Anthraquinone Reporting and Recordkeeping Require- 11/06/85 ments (Proposed Rule) P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene, 11/07/85 P-Tertr-Butylbenzaldehyde; Reporting and Record- keeping Requirements (Proposed Rule) Hexachloronorbornadiene; Submission of Notice of 11/19/85 Manufacture, Import, or Processing (and Deter- mination of Significant New Use) Additiorrof 17th ITC Report Chemicals to the 11/19/85 Section 8(a) Preliminary Assessment Information Rule (Final Rule) Polyhalogenated Dibenzo-p-dioxins/Dibenzofurans; 12/19/85 Reporting Requirements (Proposed Rule) 4,4'-Methylenebis(2-Chloroaniline); Reporting and 04/18/86 Recordkeeping Requirements (Final Rule) P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene, 05/12/86 P-Tert-Butylbenzaldehyde; Reporting and Recordkeeping Requirements (Final Rule) Addition of 18th ITC Report Chemical to the 05/19/86 Section 8(a) Preliminary Assessment Information Rule (Final Rule) 11-Aminoundecanoic Acid; Recordkeeping Requirements 07/22/86 (Proposed Rule) Chemical Assessment Information Rule (Proposed 10/07/86 Rule) Chemical Substances Inventory; Removal of 104 10/11/85 Incorrectly Reported Chemical Substances from the TSCA Inventory 117 ------- 8(c) 8(d) 9(a) 9(d) Records and Reports of Allegations of Significant 11/13/85 Adverse Reactions to Health or the Environment (Final Rule) Health and Safety Data Reporting; Urea-Formaldehyde 11/07/85 Resins (Final Rule) P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene, 11/07/85 P-Tert-Butylbenzaldehyde; Health and Safety Data Reporting Rule (Proposed Rule) Addition of 17th ITC Report Chemicals to the 11/19/85 Section 8(d| Health and Safety Data Reporting Rule (Final Rule) Polyhalogenated Dibenzo-p-dioxins/Dibenzofurans; 12/19/85 Reporting Requirements (Proposed Rule) Submissions of Lists and Copies of Health and 12/27/85 Safety Studies on Vinyl Acetate (Final Rule) Health and Safety Data Reporting; Hexachlorocyclo- 01/09/86 pentadiene (Final Rule) Submission of Lists and Copies of Health 'and Safety 01/22/86 Studies on Certain Substances Subject to the 1984 RCRA Amendments (Final Rule) P-Tert-8utylbenzoic Acid, P-Tert-Butyltoluene, 05/12/86 P-Tert-Butylbenzaldehyde; Health and Safety Data Reporting Rule (Final Rule) Addition of 18th ITC Report chemical to the Section 05/19/86 8(d) Health and Safety Data Reporting Rule (Final Rule) Health and Safety Data Reporting; Submission of 08/01/86 Lists and Copies of Health and Safety Studies on Certain Substances (Proposed Rule) Health and Safety Data Reporting Submission of 09/15/86 Lists and Copies (Final Rule) 1,3-Butadiene; Decision to Report to the 10/10/85 Occupational Safety and Health Administration 2-Methoxyethanol, 2-Ethoxyethanol and Their 05/20/86 Acetates; Referral for Additional Action Formaldehyde; Termination of Regulatory Investi- 03/19/86 gation Concerned with Occupational Exposure 4,4'-Methylene Bis(2-Chloroaniline); Termination of 06/23/86 Regulatory Investigation 118 ------- To!uenediamines; Termination of Regulatory 07/22/86 Investigation Concerned with Occupational Exposure 21 Guidance for Petitioning the EPA under Section 21 11/13/85 of TSCA 26(b) Toxic and Hazardous Substances; Premanufacture 07/11/86 Notice Fees CHEMICAL ADVISORIES Burning Used Oil 11/86 Toluenediamines 09/86 119 ------- Appendix C Chemical Hazard Information Profiles (CHIPs) Acrylic Acid 2 Brominated Diphenyl Ethers (12 chemicals) C.I. Basic Red 9 Monohydrochloride Chlorendic Acid/Anhydride (2 chemicals) Chlorinated Styrenes (9 chemicals) Chlorobromoethane Diisopropyl Sulfate Hexaf1uoroi sobutylene Nitropropane 2 Organosilanes (22 chemicals) Appendix D Substitute. Hazard Profiles. Triethanolamine N ,N' -Methyl enebi sacry 1-ami de Ammonium Persulfate Carbon (fibers) Wollastonite Ethanol Methanol Isopropanol Acetone 1-Butanol Kerosene Mineral Spirits Stoddard Solvent Cure-Rite 18 Tetrachlorophthalic Anhydride Dibromoneopentyl Glycol Tetrabromophthalic Anhydride 120 ------- Appendix E Section 4 Test Studies* Received Aryl phosphates (2 studies) Propylene oxide Tri s(2-ethylhexyl)trimel1itate (7 studies) Hydroquinone (7 studies) 1,3-Dfoxolane Antimony trioxide (3 studies) 2-Chlorotoluene (3 studies) Di(2-ethylhexyl)terephthalate D1(2-ethylhexyljphthalate (2 studies) Chlorotoluene (mixture) Cyclohexanone (7 studies) Di-(n-heptyl, nonyl, n-octyl undecyl) phthalate (2 studies) Di-isodecyl phthalate (4 studies) D'i-undecyl phthalate (4 studies) Vinylidene fluoride Trichloroethane 2-Mercaptobenzot:hi azol e 2-Mercaptobenzot:hiazole disu] fide *97 studies on 24 chemicals Di-methyl phthalate (2 studies) Di-n-butyl phthalate (3 studies) Di-(n-hexyl, n-octyl, n-decyl) phthalate (3 studies) Di-isononyl phthalate (4 studies) o-Phenylenediamines (4 studies) m-Phenylenediamines (5 studies) p-Phenylenediamines (5 studies) Butyl benzyl phthalate (6 studies) 2-Ethylhexanol Mono-2-ethylhexyl phthalate Bis(2-ethylhexyl jtrlmellitate (7 studies) Hexafluoropropylene oxide Acrylamide Di-(2-ethylhexyl)adipate Di-(n-heptyl , n-nonyl, n-undecyl) phthalate (2 studies) .Acrylamide monomer (2 studies) Appendix F NTP Studies National Toxicology Program (NTP) Studies Reviewed l-Chloro-2-methylpropene (Dimethylvinyl Chloride) Ampicillin trihydrate Chloropheniramine maleate Oxytetracycline hydrochloride Methyl methacrylate 1,1,2-Tri chloroethylene Decabromodiphenyl oxide Chlorendic acid Pentachloronitrobenzene Boric acid 1,4-Dichlorobenzene Tetra kis(hydroxymethyl) Tetra kis(hydroxymethyl) PhenyTephrene hydrochloride Mixed xylenes Rotenone Dimethyl methylphosphonate Methyl carbamate Bromodichloromethane Ethylene oxide phosphonium chloride phosphonium sulfate 121 ------- Appendix G Date Filed FY 1986 Section 21 Citizens' Petitions Who Filed Action Requested EPA's Disposition Date of Disposition 3/7/86 Chemical Waste Management That EPA amend its PCB disposal regula- tions to clarify that materials at the Model City facility may be legally landfilled withdrawn 06/13/86 11/20/85 Citizens for Healthy Progress 12/09/85 Valley Watch 04/29/86 08/18/86 Chemical Manufacturers Association Standard Chlorine Chemical Co., Inc. That EPA halt the construction of a PCB disposal facil-ity planned for Henderson, KY That EPA issue either a "proposed order" under section 5(e), or.an injunction prohibiting, the construction of the Henderson facility That EPA reconsider and withdraw Phase 1 test rule for mesityl oxide That EPA reconsider the.test require- ment for 1,2,4,5- tetrachlorobenzene denial denial denial 02/24/86 (51FR6423) 02/24/86 (51FR6423) 08/25/86 (51FR30216) pending as of 9/30/86 122 ------- Appendix H Summary of Research and Development Activities FY 1986 Accomplishments A. TEST METHOD DEVELOPMENT ENVIRONMENTAL PROCESSES o Report on techniques for effects and update of sediment-associated toxic chemicals by Benthic Marine Species. 06/86 o Report on the Fathead minnow as a surrogate for other aquatic species. 07/86 o Report on use of relative, position-specific efficiency measurement of benzo(a)pyrene metabolism as field indicators of carcinogenicity stress aquatic environment. 09/86 HEALTH o Complete development of two immunotoxicity assays in an-imals. 09/86 o Journal article on growth enhancement of human bronchial epithelial cells by nickel sulfate. 09/86 o Journal article on the use of a renal concentration test in the neonate as a predictor of long-term alterations. in urogenital morphology. 09/86 B. HEALTH: MAiRKERS. DOSIMETRY, EXTRAPOLATION o Predictive models for dose effects of asbestiform minerals. 09/86 o Journal article on the review and analysis of the literature of select chemicals and the establishment of the gene-tox data base. 07/86 o Journal article on metabolism of benzo(a)pyrene in monolayer cultures of human bronchial epithelial cells from a series of donors. 03/86 o Journal article on interspecies comparison of adult to developmental toxicity ratios. 08/86 C. SPECIAL HUMAN DATA NEEDS o Proceedings of conference on medical screening and monitoring for effects of chemical exposure in the workplace. 09/86 123 ------- D. ECOLOGY: TRANSPORT, FATE AND FIELD VALIDATION ENVIRONMENTAL PROCESSES o Journal article on environmental factors governing the kinetics of abiotic reduction transformation. 12/85 o Journal article on light-induced oxidation of pollutants involving natural inorganic species. 12/85 o Progress report on evaluation of Leffler & Taub microcosms for screening chemicals. 01/86 o Report on the influence of scale in marine microcosms perturbed by toxic chemicals derived from laboratory microcosms. 03/86 o Journal article on exposure study of organics in Delaware River using TOXIWASP. 04/86 o Journal article on SAR at the ecosystem levels single: species relative toxicity vs. ecosystem level toxicity using microcosms. 08/86 o Report on suitability of biodegradation information from fate screen tests for predicting fate of toxic organic compounds in microcosms and' field studies.. 09/86 E. ENGINEERING- o Preliminary assessment of predictive techniques for extraction,. flaking, and agglomeration unit operations. 01/86 o Evaluations of procedures and methodology of asbestos abatement. 03/86 F. EXPOSURE MONITORING o Interim report on pollutant sources and human exposure to toxic pollutants using TEAM Data - FY 86. 12/85 G. STRUCTURE-ACTIVITY RELATIONSHIPS HEALTH o Report on how to use molecular electrostatic potential to make risk assessments on chemically induced toxicity for one class of chemicals. 09/86 o Report on SAR studies on azoreductase II. 09/86 124 ------- ENVIRONMENTAL PROCESSES o Report on a comprehensive structure-toxicity method to estimate toxicity of chemicals to aquatic organisms. 03/86 o Report on SAR methods to predict major metabolites of industrial chemicals. 08/86 o Report on SAR identification of.potential tumorogenic industrial chemicals. 09/86 o Journal article describing relationships between microbial degradation rate constants and chemical properties. 09/86 H. BIOTECHNOLOGY ENVIRONMENTAL PROCESSES o Report on data base for detecting, identifying, and enumerating novel organisms in terrestrial environments. 01/86 o Report on development of data base assessing genetic stability of novel organisms. 02/86 ECOLOGY: ECOTOXICITY AND- RISK ASSESSMENT ENVIRONMENTAL.PROCESSES o Journal article on model developed to describe exchange of non-polar hydrophobic toxicants across fish gills. 08/86 o Computer program of gill exchange model for predicting bioaccumulation of hydrophobic xenobiotic chemicals. 09/86 J. SUPPORT MONITORING o Guidelines for field testing soil, date, and transport models - Final report. 04/86 o Report on Asbestos Audit Program. 09/86 ENVIRONMENTAL PROCESSES 0 Final report on chronic toxicity of phthalate esters to Daphnia and Fathead minnows. 03/86 125 ------- |