Office of Toxic Substances

Toxic Substances Control Act, Public Law No. 469, 94th U.S. Congress Chemical Substance Inventory, U.S. Environmental Protection Agency, Office of Toxic Substances, Wasliiagton, D.C., 1975. 

TSCA sec. 8(d) submission 878214937/ Summary of environmental data, Dow item 1594, The Dow Chemical Company, Office of Toxic Substances, U.S. EPA, Washington, D.C., 1985. 

Ciba-Geigy. 1984e. TSCA sect. 8(d) submission no. 86-870000078. Hydrolysis report with cover letter dated 01/09/87. Washington, DC Office of Toxic Substances, U.S. Environmental Protection Agency. Microfiche no. 513263. 

EPA. 1979a. Environmental Protection Agency. Analysis of aryl phosphate samples. Intra-Agency memorandum from A.B. Crockett, Environmental Monitoring and Support Laboratory, Office of Research and Development to P. Hilgard, Office of Toxic Substances. 

An application of transport and compartment-type models to hazard analysis is described in the paper by Honeycutt and Ballantine (19). The compound CGA-72662 running off from agricultural areas into surface waters was modeled in order to set safe application procedures consistent with the protection of aquatic environments. Patterson, et al (2 0) have adapted the UTM model to a software package that is generally applicable to fate assessments of toxic substances in air, water, soil and biota. Their work, now in working draft form, is being used by Dr. William Wood and Dr. Joan Lefler in the Office of Toxic Substances of the U.S. Environmental Protection Agency. 

For a limited number of exposure pathways (primarily inhalation of air in the vicinity of sources), pollutant fate and distribution models have been adapted to estimate population exposure. Examples of such models include the SAI and SRI methodologies developed for EPA s Office of Air Quality Planning and Standards (1,2), the NAAQS Exposure Model (3), and the GEMS approach developed for EPA s Office of Toxic Substances (4). In most cases, however, fate model output will serve as an independent input to an exposure estimate. 

L. Hall, "The OTS Graphical Exposure Modeling System (GEMS)." Pre-publication Draft, EPA Office of Toxic Substances, July 20, 1982. 

EPA. 1990. Uptake of lead from formula and food by infants Reanalysis of the Ryu et al. data. Draft final report. US Environmental Protection Agency, Office of Pesticides and Toxic Substances Exposure Evaluation Division, Office of Toxic Substances. 

Protection Agency, Office of Toxic Substances. EPA 560/2-78-003. NTIS No. PB-285881. 

Wasik, S.P., Tewari, Y.B., Miller, M.M., Martire, D.E. (1981) Octanol/Water Partition Coefficients and Aqueous Solubilities of Organic Compounds. NBSIR 81-2406, report prepared for Office of Toxic Substances, Environmental Protection Agency, Washington, DC. 

First, of all, I would like to clarify the term "new chemicals." I am referring to the TSCA definition as those chemicals not listed on the TSCA Chemical Substance Inventory and maintained on a daily basis by the Office of Toxic Substances within EPA. This is a list of all commercial chemicals - some 55,000 in all - produced in or imported into the United States during the period of 1975 through 1979. My talk this afternoon will not cover the thousands of formula changes in mixtures of chemicals which occur almost daily as industry tries to meet changing market demands. 

Neverthless, it is possible to analyze the information supplied by industry on new chemicals and summarize it in a way which does not breach CBI. This is what I have done in preparing this paper and it is the work of many of my cohorts within the Office of Toxic Substances. I intend to summarize the experience of EPA in dealing with these notices including an analysis of the classes and types of new chemicals, market areas, company size and other data. From this I will draw some conclusions about the impact of this requirement of TSCA on new product innovation and will describe what EPA is doing about it. 

The Office of Toxic Substances has assembled a team of multi-disciplined scientists to review each of these PMNs and assess the potential risks to human health and the environment posed by commercial manufacture and sale. These assessments are based upon limited firm data on the specific chemical, comparison with structurally similar chemicals of known toxicity, plus estimates of exposure from calculations of the potential number of people involved in manufacturing and processing operations and in consumer use. Most PMNs contain elementary data on physical and chemical properties and obvious acute health effect such as skin... 

Under the new administration, this section of TSCA has come under the scrutiny of Vice President Bush s task force on regulatory relief and the Office of Toxic Substances is placing a high priority on efforts to develop more cost-effective means for achieving industry compliance with OTS policies. In addition to fostering voluntary actions by industry wherever possible in lieu of formal rules, these effects include elimination of unnecessary burdens on industry in complying with mandated TSCA requirements. 

The Office of Toxic Substances is devoting substantial resources to issuing exemptions to PMN requirements which should still further reduce the regulatory burden. Naturally, these exemptions will cover only those new chemicals which are expected to pose no unreasonable risk to health or the environment. As you heard this morning from David Zoll of CMA, we are approaching this... 

So my message to the chemical industry broadly and in particular to the segment of small businesses is to not let the PMN requirements limit your creative spirit in the development and commercialization of new chemicals. The Office of Toxic Substances in EPA stands ready to assist you at no cost in filling out the forms and distinguishing clearly what is minimally essential for risk assessment purposes from what is optional. We have trained consultants in the northeastern and mid-west sections of the country ready to travel to your location and advise you in a confidential way on PMNs. Our staff in Washington can be immensely helpful and you should feel free to discuss your specific situation with them. And, to top it off, we have one recently-retired experienced chemcial industry man concentrating his entire effort to assist the small business man in any TSCA-related matter. His name is Dr. Bob Toomey give him a call on the Industry Assistance Office toll-free line. 

Mr. Don Clay, Director of the Office of Toxic Substances, discussed the premanufacture review procedures and experience with PMNs to date at a meeting of the Organization for Economic Cooperation on Development (OECD) Chemicals Forum in December, (10). He noted that EPA s chemistry, toxicology, and exposure assessment teams normally complete their preliminary evaluation within a week of receipt of a PMN, and, that preliminary assessment eliminates about 50 percent of the substances as chemicals of low concern. They then proceed to structure activity analysis and reasonable worst case assumptions to assess unreasonable risk or the need for more data. 

This should not be too surprising. They started from scratch in 1977 with only a handful of people. Today the Office of Toxic Substances is 600 strong. In fairness to the Agency, it takes time to hire and train the people to do an effective job with a new "balancing-type" law. 

This paper does not address EPA plans for further implementation of sections 5 and 8 of TSCA. The agency is active in both areas. For information on future plans.refer to the most recent EPA publication of its events calendarand EPA.Office of Toxic Substances report Priorities for OTS Operation --. ... 

I now shall present a summary of an application of decision analysis to a specific chemical, perchloroethylene (PCE), a widely used dry cleaning solvent (also called tetrachloroethylene). Full details of this application are presented in an EPA report (5). Perchloroethylene was selected for us by the staff of the EPA Office of Toxic Substances as representative of chemicals on which EPA needed to make an unreasonable risk determination under TSCA. Our analysis was carried out as an exercise in methodology development and not to support any specific regulatory activities by EPA concerning perchloroethylene. 

Campbell, G. L. Cohan, D. and North, D. W. "The Application of Decision Analysis to Toxic Substances Proposed Methodology and Case Studies" prepared by Decision Focus Incorporated for the Office of Toxic Substances, Environmental Protection Agency, 1982. 

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