Document amwakB9Md3wa41gN422rdnOY

TO: Distribution FROM: DATE: Interoffice Communication SUBJ: T. G. Grumbles May 8, 1987 SPC AT EPA EPA is also into process flow diagrams. Attached is a simplified flow description of what happened to our recent EDC 8(e) notification. crw T. G. Grumbles ajo Attachment DISTRIBUTION: M, G. Hayes E. R. Taylor J. A. DeBernardi R. A. Conrad W. L. McGlain R. T. Ferrell cc H, J. Neeld A VVv 000008954 An Overview Section 8(e) of the Toxic Substances Control Act Section 8(e) of the Toxic Substances Control Act (TSCA) states that "any person who manufactures. [imports.J processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the envi ronment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information." Section 8(e) became effective on January I. 1977, the effective date of TSCA. A Section 8(e) policy statement ("Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk"), which clarified the types of information to be submitted and the procedures for doing so, was published in the Federal Register on March 16. 1978 (43 FR 11110). Since January 1, 1977, a large number of Section 8(e) notices covering a wide range of chemical toxicity/exposure information have been received and given priority evaluation and appropriate followup attention by the Office of Toxic Substances (OTS) (see reverse). Upon receipt of a Section 8(e) submission, OTS prepares a status report which contains a description and preliminary assessment of the submitted information, a statement regarding production and use(s) of the subject chemical(s), and recommendations for appropriate OTS followup actions/activities. EPA's implementation of Section 8(e) has brought about heightened corporate awareness of potential chemical risks, leading to voluntary company actions designed to protect human health and the environment. Many companies have reported that in direct response to submitted chemical toxicity/exposure information, the following types of health and environmental protection measures were initiated: Notification of workers, customers, and others Labelling and Material Safety Data Sheet (MSDS) changes made Manufacturing, processing, and/or handling changes made Chemical production or use halted temporarily or discontinued altogether Additional toxicity/exposure studies performed. The chemical industry's increased awareness of potential risks posed by chemicals to health and the environment is evidenced further by many voluntary industry submissions received by OTS on a "For Your Information" (FYI) basis. High-level scientific and administrative contacts have been established by OTS in each of EPA's Program Offices and in other Federal agencies (e.g., NIOSH, OSHA. CPSC, FDA, NTP) in order to provide a mechanism for timely and prioritized dissemination of information concerning newly discovered hazards/risks associated with exposure to chemical substances or mixtures. For further information regarding TSCA Section 8(e), please call: David R. Williams (TS-778J TSCA Section 8(e) Coordinator Office of Toxic Substances U.S. Environmental Protection Agency 401 M Street, SW Washington, DC 20460 Telephone: (202) 382-3468 VVV 000008955 Office of Toxic Substances Existing Chemical Assessment Division U.S Environmental Protection Agency 3/87 Processing of 8(e) Notices of Substantial Risk r Notice _L_ DCO IMD Log In Acknow. Letter Public File Sanitized Copy Acknow. Challenge Letter Response NonConfidential Public File Claim Upheld OGC Review t Claim | Waived [ 8(e) Coordinator CRIS TSCA CBI Procedures In Effect; Only Authorized Persons Involved In Process IMD: Information Management Division/OTS CRIS: Chemical Risk Identification Section/CSB HERD: Health & Environmental Review Division/OTS CSB: Chemical Screening Branch/ECAD/OTS OGC: Office of General Counsel OCM: Office of Compliance Monitoring DCO: Document Control Office/IMD OTS- Office of Toxic Substances ECAD: Existing Chemical Assessment Division/OTS IMD Distribution Appropriate File Confidential Public David R. Williams Section 8[e) Coordmator/CRIS/CSB Telephone: (202) 382-3468 FTS: 382-3468 James F. Darr Section Head/CRIS/CSB Telephone: [Z02| 382-3470 FTS-382-3470 Frank D. Kover 8ranch Chief/CSB Telephone: [202) 382-3436 FTS-382-3436 Followup Activities l EPA CPSC FDA NIOSH OSHA Others Followup Letter to Submitter VVV 000008956