Reproductive and Developmental Hazards:

Regulatory Actions Provide Uncertain Protection

T-PEMD-92-1: Published: Oct 2, 1991. Publicly Released: Oct 2, 1991.

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GAO discussed the extent and sufficiency of federal regulation of toxicants that cause adverse reproductive and developmental outcomes. GAO noted that: (1) major obstacles to regulatory consideration of reproductive and developmental hazards include the lack of scientific knowledge regarding reproductive and developmental toxicity and the lack of quantitative risk assessment protocols; (2) no federal agency is required to publish a list of known human reproductive toxicants and no authoritative federal listing is available for those diseases; (3) agencies reported taking 138 major regulatory actions on the 30 toxicants reviewed, including 20 cases of banning or cancelling selected toxicants, 97 cases of setting numerical standards or restrictions, and 21 cases of guidance or guidelines; (4) all but 1 of the 30 chemicals are covered by 1 or more major regulatory actions, two-thirds are covered by at least 4 actions, and 7 are covered by 7 or more actions; (5) agencies have not consistently applied reproductive and developmental toxicity data in making regulatory decisions, focusing instead on cancer and acute toxicity; (6) 40 percent of the experts surveyed judged federal regulation of reproductive and developmental toxicants as fair and 38 percent judged it as poor to very poor; (7) in roughly half of the cases, agency officials judged their own standards and guidelines to be of uncertain protection against reproductive disease; and (8) 25 percent of the 138 regulatory decisions were made before 1980 and need revision because reproductive data available at the time were not considered or new data have become available.

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