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| EPA/OPPTS | RIN: 2070-AJ13 | Publication ID: Fall 2008 |
| Title: Testing Agreement for Maleic Anhydride | |
| Abstract: Section 4 of TSCA gives EPA the authority to require chemical manufacturers and processors to test existing chemicals. Under Section 4, EPA can by rule require testing after finding that (1) a chemical may present an unreasonable risk of injury to human health or the environment, and/or the chemical is produced in substantial quantities and enters the environment in substantial quantities or there is or may be significant or substantial human exposure to the chemical, (2) the available data to evaluate the chemical are inadequate, and (3) testing is necessary to develop the needed data. The Chemical Testing Program in EPA's Office of Pollution Prevention and Toxics (OPPT) also works with members of the U.S. chemical industry to develop data via TSCA Section 4 Enforceable Consent Agreements (ECAs) and Voluntary Testing Agreements (VTAs). ECAs and VTAs are usually less resource intensive than formal TSCA rule-making. In developing ECAs and VTAs EPA may consider agreed-upon pollution prevention and other types of product stewardship initiatives by the chemical industry as a possible substitute for or adjunct to certain types of testing. EPA proposed health effects testing under TSCA section 4(a) for a number of hazardous air pollutants ("HAPs"), including maleic anhydride (61 FR 33178, June 26, 1996 (FRL-4869-1), as amended by 62 FR 67466, December 24, 1997 (FRL-5742-2). In the proposed HAPs test rule, as amended, EPA invited the submission of proposals for developing needed HAPs data via ECAs, including developing pharmacokinetics studies that would permit extrapolation from oral data to predict risk from inhalation exposure. In response to EPA's request for proposals for ECAs, the Maleic Anhydride (MA) Panel submitted a proposal for alternative testing involving PK studies for MA on November 8, 1996. EPA responded to the Panel's proposal by letter on July 10, 1997, indicating that this approach could offer sufficient merit to proceed with ECA negotiations. Under this action, EPA will continue negotiations to develop an ECA for health effects testing data specified in the proposed HAPs Section 4 test rule, as amended. | |
| Agency: Environmental Protection Agency(EPA) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 40 CFR 790 to 799 | |
| Legal Authority: 15 USC 2603 TSCA 4 | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: SAN No. 3493.6 | |
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Information URL: http://www.epa.gov/oppt/chemtest | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Bob Jones Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7405M, Washington, DC 20460 Phone:202 564-8161 Fax:202 564-4765 Email: jones.robert@epa.gov Mike Mattheisen Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7405M, 1200 Pennsylvania Avenue NW., Washington, DC 20460 Phone:202 564-3077 Email: mattheisen.mike@epa.gov |
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