In one of his last official acts as EPA administrator, Douglas Castle on Jan. 19, 1981, signed a highly controversial document setting forth the agency’s policy on the preknufacture testing of new chemical substances. The debate over premanufacture testing has a long history. Bills to regulate toxic substances passed both houses of Congress in 1972 and 1973 but were never enacted into law, due largely to disagreement over the testing issue. The Toxic Substances Control Act was finally passed in 1976, but over testing has conto this day. In its reent, EPA acknowlCA does not establish uirement that premanufacture performed on all new ubstances,” but then prod s to establish a detailed “base set that the agency recommendsas rting point for premanufacture ’’ (40 FR 8986, Jan. 27, 1981).
new chemical testing.” Second, EPA has been working for three years to achieve “international testing harmonization” through the Organization for Economic Cooperation and Development (OECD), which consists of 24 nations, including mast of the major chemical-producing countries of the non-Communist world. The two basic elements of EPA’s guidance-a base set of data to be developed by manufacturers and recommended test protocols for developing the data-are both contained in the OECD proposals, which are scheduled to be voted upon by its Governing Council early next year. EPA maintains that its policy reflects the need for flexibility and scientificdiscretion in determining what tests are appropriate. Finally, EPA alleges that the data it receives under the premanufacture notice requirements is often insufficient to make an informed judgment about a chemical‘s ultimate impact.
Industry’s objeetions Industry vociferously challenges EPA’s policy. First, it argues that TSCA and its legislative history make plain that Congress specifically ruled out the type of premarket testing contained in EPA’s guidance. It did soon the basis that testing of chemicals likely to cause damage to health or the environment is already required by the act. Second, industry maintains that while the agency’s recent “policy statement” is couched as “nonbinding,” it will become defacto regulation and any submission by industry will be judged against the published policy. Industry feels strongly that a specific set of tests for chemicals of widely differing characteristics and intended uses, some involving worker or other human exposure and some not, simply does not make sense. Another concern of industry is that the cmt of the tests, estimated to range
base set, will substantially stifle t development of new chemicals study conducted by Arthur D. L for EPA in 1978 found that of the 1
exclusive of testing, $9000 and $42 000 an
The Reagan reaetiea President Reagan has pledged to reduce “the burden of existing and future regulations” and his recent executive order is broadly enough drafted to include “policy” statements as weU. EPA’s premanufacturing testing policy looms as a prime candidate for such
likely to become t curtailing industria
The debate over premanufac testing policies initiated in the e
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