GOVERNMENT
Changes in New Chemical Rules Drafted In one of Congress' initial efforts to rewrite the Toxic Substances Control Act, staff members of the Senate Environment & Public Works Committee have prepared a preliminary draft of possible amendments dealing with registration of new chemicals to be used in commerce. Among those proposals are putting compounds on a two-track registration system depending on their supposed toxicity, requiring some additional toxicity tests for chemicals, and mandating a list of chemicals presumed to be toxic. TSCA is one of the most controversial laws under the jurisdiction of the Environmental Protection Agency. Passed in 1976, TSCA covers the manufacture and use of new and existing chemicals and provides an inventory of chemicals used by manufacturers. It also serves as kind of catchall, giving EPA the potential authority to regulate chemicals and situations that it may not have under other laws. In rewriting the law, one of the first sections to be tackled is that dealing with registration of new chemicals (section 5). That section, says Ronald B. Outen of the Senate committee staff that prepared the proposed amendments, is where some of the biggest problems are. The amendments would change the current registration process most visibly in the area of premanufacture notifications. PMNs currently filed by chemical companies seeking to make a new product have been criticized heavily for incompleteness and for containing large amounts of data labeled "trade secret/ 7 A detailed analysis of PMNs by the Office of Technology Assessment a year ago added credence to those complaints, finding that as many as 47% of the PMNs submitted to EPA contain no toxicity data at all. Although the OTA report may have exaggerated this problem, the Senate staff is considering changes to eliminate it as well as shift the bur18
July 9, 1984 C&EN
Certain chemicals would be defined as hazardous The proposed amendments to TSCA now being worked on in the Senate include a mandatory list of chemical categories that would be considered hazardous and require special testing before they could be used. Although the list may be modified, refined, and some categories even dropped, the list would have to be used. Based on a preliminary list supplied to the environment committee by EPA Administrator William D. Ruckelshaus earlier this year, the chemicals that could be declared hazardous by Congressional fiat include: • Acrylates with fewer than 12 carbon atoms. • Polyacrylates with molecular weights less than 1000. • A variety of aromatic amines and azo compounds. • Dithiophosphate esters. • A variety of epoxides. • Glycol ethers. • Phthalates. • Polyhalogenated aromatics. • A number of substituted pyridines. • Quaternary ammonium compounds. • Thio and alkyl ureas.
den of showing a chemical is safe from EPA to industry. Currently, if EPA does not get enough information to tell if a chemical is hazardous, it has little leverage to force the submitter to add more. The amendments would give EPA more authority to pressure the company for data. Requiring companies to do specific tests and to include the results in their PMNs would, it is hoped, provide better data for EPA to make decisions. What the Senate staff is considering are the same sort of tests presently called for in guidelines developeid by the Organization for Economic Cooperation & Development, Outen says. These include
about 10 basic toxicity tests and physical and chemical information. Companies could ask for exemption from the tests but they would have to file, along with their PMN, an explanation of why the required data are not included. Reasons that would be considered acceptable include it not being technically possible to perform the test or a convincing statement that manufacture of the chemical will in no way present an unreasonable risk to people or the environment. Just what tests had to be done for a particular chemical also could be a matter for negotiation between the submitter and EPA. Although companies might have to submit more data, the draft amendments try to speed up EPA's PMN review process by setting up a two-track system. Low-volume chemicals and site-restricted intermediates would be expected to be reviewed within 30 days. Other chemicals would continue to undergo a 90-day review. The key to what would be heavily scrutinized would be a new list of chemicals deemed potentially hazardous. The EPA administrator has had the authority to draw up a list of suspected problem chemicals but has not done so. Although Congress asked for such a list more than a year ago, none has surfaced. However, based on information in a letter from EPA Administrator William D. Ruckelshaus, the environment committee staff has listed 10 categories of compounds that it feels is a good beginning for a presumptive toxicity list. Companies submitting PMNs for chemicals on the list would have to show specifically that the chemical is not a hazard. There is no specific timetable for amending TSCA, as the staff is working through it a section at a time. Outen says that the way things are going now, it is likely that hearings will be held late this year or early next year. David Hanson, Washington
