Section 8e reporting also must be done in a relatively short time frame. As noted in the june 3, 2003, federal register notice, the 2003 guidance document contained earlier guidance issued on tsca section 8e that had not been changed and that was being reprinted for the convenience of all interested persons. A large body of epidemiologic evidence exists for exploring causal associations between cancer and trichloroethylene tce exposure. Epa is announcing that notifications of substantial risk under section 8e of the toxic substances control act tsca and voluntary for your information fyi submissions may now be filed electronically using epa s electronic document submission system, the central data exchange cdx. Environmental protection agencys strategic plan for evaluating the toxicity of chemicals, which serves as a blueprint to ensure a leadership role for epa in pursuing the directions and recommendations presented in the 2007 nrc report. Environmental protection agency 2001 draft tce health risk assessment concluded that epidemiologic studies, on the whole, support associations between tce exposure and excess risk of kidney cancer, liver cancer, and. Tsca section 8e reporting guide pdf122 pp, 5 mb, june, 1991. The reader can be downloaded and used with no charge. In the federal register of february 1, 1991 56 fr 4128, the. There appears to be an opportunity, therefore, for the agency to revise its historical guidance and expand the reporting obligation in the future.
Reporting substantial risk information under section 8e of tsca. National environmental health association, the bureau of health professions of the u. Impact of a 1991 decision by the fifth circuit court on section 6. In the federal register of february 1, 1991 56 fr 4128, the agency announced a onetime voluntary tsca section 8e cap. Under the toxic substances control act tsca, as amended by the frank r. Introduction to the chemical import requirements of the. Epa explained that these sections of the 1978 policy statement need additional clarification and that possible misinterpretation with regard to the guidance in these sections could lead to overreporting. Us epa, office of pollution prevention and toxics oppt chemical. In 1991, the united states court of appeals for the fifth.
The alj held that elementis chromium elementis failed to report to the u. This timing, coupled with the fact that the epa requires that ehs information contained in limited studies, preliminary. Epas stated commitment to issue guidance on these issues will greatly assist the. In contrast, elementis maintained that according to epa s 1991 guidance the study was corroborative because it contained information that confirmed a wellestablished adverse effect, and did not show that the effects acknowledged by both parties that hexavalent chromium caused lung cancer in people occurred at lower levels of. Federal register 56 fr 63798 63826, december 5, 1991. Epas enforcement action against dupont involves the synthetic chemical amonium.
Compliance guide for the chemical import requirements of. Some publications are available as both html and pdf files. Implementation and new challenges summary title i of the toxic substances control act tscaof 1976 has never been amended, but recent legal, scientific, and technological changes are prompting some policy makers to reexamine the law. Federal register tsca section 8e reporting guidance. Epa is announcing that notifications of substantial risk under section 8e of the. This guide describes the chemical imports requirements under the toxic. Lautenberg chemical safety for the 21st century act, epa evaluates potential risks from new and existing chemicals and acts to address any unreasonable risks chemicals may have on human health and the environment. Four major goals comprise oppts mission and guide all oppt programs. Consent agreement and proposed final order to resolve duponts. Compliance guide for the chemical import requirements of tsca compliance guide for the chemical import requirements of tsca 12. United states environmental protection agency office of water 4305 epa 823b01002 october 2001 methods for collection, storage and manipulation of sediments for chemical. Guidance documents on substantial risk notifications under tsca on june 3, 2003, epa finalized revisions to its 1978 tsca section 8e policy statement. Overview of the draft iris assessment of ammonia presentation for the ammonia augmented chemical assessment advisory committee of the science advisory board july 14, 2014 susan rieth, mph audrey galizia, m. Cost of illness handbook united states environmental.
Us epa pesticide regregistration chemical status page. The 1978 policy statement described the types of information that epa considers reportable under section 8e and described the procedures for reporting such information to epa. This revised guidance was published in its entirety, after notice and comment, in the federal register and is entitled. This information is submitted in accordance with current guidance issued by epa indicating epa sinterpretation of section 8e ofthe toxic substances control act or, where it is not clear that reporting criteriahave been met, it is submitted as a precautionary measure and because it is information in which epa may have an interest. Epa guidance requires that entities subject to this provision submit the relevant information within 30 days of receipt. Assistant administrator, office of chemical safety and. On march, 2015, the environmental appeals board eab overturned a controversial decision issued by an administrative law judge alj in 20. Introduction to the chemical import requirements of tsga chemical substance or mixture, which epa has determined is imminently hazardous, andor for other relief against any person who manufactures imports, processes, distributes in commerce, uses, or disposes of an imminently hazardous chemical substance or mixture or any article. This final rule, issued pursuant to section 8d of the toxic substances control act tsca and its regulations, requires manufacturers including importers of consumer products intended for use by children who also manufacture including import lead or lead compounds to report certain. Guidance documents on substantial risk notifications under. Although this final rule document and supporting information will appear in docket epa hq oppt 20160461, both dockets for the proposed rules epa hq oppt 20110380 and epa hq oppt 20120018 contain supporting information with respect to this rule and should be considered merged for the purpose of this final rule. Environmental protecting agency epa a study on occupational exposure involving hexavalent chromium, in violation of section. The failure to clean up tsca poisons public health and. Environmental appeals board vacates penalties for tsca.
Tsca work plan chemical problem formulation and initial. Implementation guidance on cafo regulations cafos that discharge or are proposing to discharge 1 may 28, 2010 epa 833r6 implementation guidance on cafo regulations cafos that discharge or are proposing to discharge. Tsca section 8e reporting guide tsca section 8e reporting guide june 1991 notice to administrator of substantial risks. Environmental protection agency guidelines for devel opmental toxicity risk assessment. Tsca and engineered nanoscale substances the acta group. Chemical enforcement division, office of civil enforcement, united states environmental protection agency epa or agency, filed a complaint and notice of opportunity for hearing complaint pursuant to section 16a of the toxic substances control act tsca.
In order to develop effective wqbels, permit writers must be familiar with state water quality standards methods for predicting water quality impacts from discharges, and. Cwa and epa regulations require development of more stringent, water qualitybased effluent limits wqbel designed to ensure that water quality standards are met. This reporting guide has been compiled by epa s office of toxic substances ots to assist potential respondents who manufacture, import, process or distribute chemical substances in complying with section 8e, the substantial risk information reporting provision of the toxic substances control act tsca. In addition, opp recently announced an esubmission initiative to help epa move toward a more paperless environment. As described in the opinion, under these guidance documents, epa is adequately informed of information that is corroborative of a wellestablished adverse effect. Publications about indoor air quality indoor air quality. Epa has evaluated this substance for potential human carcinogenicity, a summary of that evaluation will be contained in section ii of this file. Assessment manager national center for environmental assessment office of research and development.
Environmental appeals board decision in the elementis case. Environmental protection agency 2001 draft tce health risk assessment concluded that epidemiologic studies, on the whole, support associations between tce exposure and excess risk of kidney cancer, liver cancer, and lymphomas, and, to a lesser extent. Toxic substances control act notifications of substantial risk and for your information submissions agency environmental protection agency epa. Any person who manufactures, imports, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion. Page 2 tsca section import compliance checklist purpose how to comply with tsca import certification requirements this checklist provides a simplified roadmap to help chemical importers walk through the logical analysis needed to determine how to certify their chemical imports in order to comply with the regulatory requirements under.
This reporting guide has been compiled by epas office of toxic. Epa is correcting certain language that was inadvertently changed from the march 16, 1978, tsca. Office of wastewater management water permits division. Epa guidance defines substantial risk of injury to health or the environment as a risk. Section 8e reporting guide june 1991 available in hard copy from. Opp has established adobe portable document format pdf as the standard file format for the electronic submission of required studies, using compact disks as the transport medium.
608 1346 467 974 290 8 549 658 26 1078 518 1433 1094 713 445 530 1504 1405 881 476 1467 33 307 978 728 1355 212 1340 1036 494 852 903 145 972 409 260 1315 188 880 724 1389