Government
EPA revising pesticide registration program More thorough checking of safety data on products helps to put Environmental Protection Agency three years behind original schedule The Environmental Protection Agency's pesticide reregistration program has ground to a halt, and all because the agency made one erroneous assumption when it was planning the program in 1973. As a result of findings by the General Accounting Office and a Senate subcommittee this spring, EPA has discovered that it simply isn't enough to reregister a product on the basis that data to support the safety of the product had been submitted when the product was first registered. The agency now recognizes that it must go back and determine the accuracy of that data. It must also determine that data problems identified by prior reviewers have been followed up and resolved. Reregistration of some 35,000 products, as mandated by the 1972 Federal Environmental Pollution Control Act, finally got off the ground this January. EPA concentrated its efforts on the about 1500 active ingredients used in the 35,000 formulations. It was already too late a start for the agency to meet the October 1976 deadline called for by the law. Instead, EPA was aiming to complete its task by October 1977. About 2500 products representing 650 active ingredients had been registered without too many hitches when GAO and the Senate Subcommittee on Health came out with their findings this March. Now the agency says it won't be able to finish the project any earlier than October 1979. GAO and the Senate Subcommittee on Health, chaired by Sen. Edward M. Kennedy (D.-Mass.), had questioned the validity of data submitted by pesticide manufacturers to support the safety of their products. Evidence had surfaced at the subcommittee hearings that some laboratories performing and reporting tests for pesticide and drug producers were falsifying data or were testing and reporting in a scientifically incompetent or inadequate manner. Witnesses suggested that a laboratory's independent scientific judgment might be impaired by its close economic relationship with a pesticide manufacturer on which it is dependent for contract work. Or, they said, the laboratory could be intentionally
misrepresenting test results at the request of the manufacturer. Just what is EPA's strategy following these revelations? Edwin L. Johnson, deputy assistant administrator for pesticide programs, summed it up in a speech he gave before the Pesticide Formulators Association late last month. The agency is taking several steps, Johnson says. It is looking at the data files more closely to check the accuracy and to determine if proper followup has been made in the past. It is developing standard procedures for staff reviewers to document their findings, so that a clear record is established leading to a decision. And it is looking at primary literature sources and consulting with other agencies. The heart of the new strategy, Johnson explains, will be a chemical review file. Each chemical will have its own file, which will contain a summary of prior reviews, citations of acceptable environmental chemistry data, summary of use history, summary of use patterns by formulation, summary of inputs from other sources, and formal observations and recommendations from the compiler of the file. A review panel, consisting of scientists, lawyers, and policy makers within EPA will look over the files and determine if the recommendation for reregistration should be approved, or if cancellation or other actions are warranted. Using this strategy, Johnson says that EPA expects to complete reregistration procedures for about 200 active ingredients by July 1977, including those whose uses are restricted to professional applicators. During 1977, EPA also will register or cancel products triggering presumptions against registration on the basis of their potential chronic health effects. It will make the basic registration process more workable by improving data cataloging, data validation, and regional support to help small firms properly make applications, particularly when minor uses are involved. Between 1977 and 1979, EPA aims to reregister all products destined for general use, Johnson adds. Simultaneous with coming to grips with the data reliability problem in the reregistration program, EPA has initiated, with the help of the Food & Drug Administration and the National Cancer Institute, an auditing program to examine the validity of toxicity tests that are submitted with applications to register new pesticides. FDA is developing a training program for auditing personnel. And NCI is providing insight from its own auditing program. As part of the auditing program, EPA is preparing a manual describing generally what the agency expects in toxicity test
Johnson: chemical review file reports, such information as proper test methods, post mortem examination of animals, and statistical evaluation of test results. Earlier this month, the agency asked for public comments on what should go into these reports. For instance, should EPA require that each report identify not only the laboratory where the tests were performed but identify the supervisers and director of the laboratory too? Should the director sign and certify that a report is true and complete? In addition to the data reliability problem EPA must settle the question of how best to regulate health hazards associated with petroleum derivatives that are used as inert as well as active ingredients in pesticide products. Petroleum distillates, Johnson said in his speech, may be posing a much greater problem in areas where the pesticide program has no regulatory control, such as in air pollution, energy, or petroleum-based food additives. And even more of a problem is the issue of trade secrets, Johnson points out. Under current agency policy, EPA makes data submitted by companies available to other companies that might want to use the data in support of their registration applications. To date, 10 suits have been brought to court, with the plaintiffs claiming that making their data available to other companies is a violation of the confidentiality of their trade secrets. As a result, several thousand products are awaiting registration or reregistration pending the outcome of these cases, Johnson says. D Oct. 25, 1976 C&EN
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