EPA High Production Chemicals Review Committee Suggested By P&G

Procter & Gamble proposes the Environmental Protection Agency establish a scientific review committee to enable EPA's high production volume chemicals program "to progress more efficiently and to minimize unnecessary duplicative animal testing."

In a recent letter to the EPA, P&G suggests the proposed committee could "serve as consultants for development of all phases of the chemical evaluation programs, including data adequacy, use of data from related chemicals, formation and validation of categories, testing protocols, etc." In addition, the EPA group "would be available to review and approve, in a timely fashion, any portion of the evaluation strategy that is controversial," P&G adds.

The company recommends using the "scientific expertise" of the Society of Toxicology and the Society of Environmental Toxicology and Chemistry to establish the committee.

P&G was one of 900 chemical manufacturers that received a letter from EPA in the fall requesting the company voluntarily join the Chemical Right-To-Know HPV Challenge Program by March 15 ("The Rose Sheet" Jan. 25, p. 6). Companies not in compliance with the initiative may be listed in an upcoming Federal Register proposed rule.

EPA's Chemical Right-To-Know Program was established to conduct safety testing on 2,800 high production volume chemicals to obtain basic toxicity information on chemicals in significant distribution in the U.S. and provide the data for consumers in a public forum.

While P&G said its comments are not in direct response to the Right-To-Know initiative, the company has been working both independently and through the Chemical Manufacturer's Association with EPA on the subject of HPVs.

P&G is "concerned that [EPA's] current approach to the HPV program continues to be focused almost entirely on a need for check-box animal and ecotoxicological testing." The initiative requires all chemicals be tested without consideration for the safety data available from other federal agencies, the company states.

For example, P&G says 300 of the 2,800 HPV chemicals are approved for use either in or on food. "Many of these materials could be eliminated from HPV testing on the basis that toxicology data on them is available from and maintained by FDA, and also based on their long history of safe as use as food ingredients."

The agency's "overwhelming emphasis on testing, coupled with the envisioned scoring system, makes testing the path of least resistance, providing less incentive to look at all available data and develop scientifically valid safety assessment without further animal testing," the company maintains.

"This approach completely discounts the many advances in toxicology and risk assessment that have been made in the past years, particularly science-based testing strategies that minimize the use of animals."

The HPV program centers on "a specific set of environmental and animal tests" and does not take into consideration whether additional assays would benefit a specific chemical, P&G states. Rather, testing strategies "should utilize all available data" such as the human experience, mechanistic understanding and recognized differences between species.

In communications with companies, EPA "consistently emphasizes only the testing aspect of the program," P&G contends. The agency instead should ask industry to provide safety data on individual chemicals for production, transport, use and disposal.

P&G also argues EPA should offer "strong incentives" for companies to "find and evaluate all safety data before deciding to run additional animal testing." The agency's current position on data adequacy "appears overly restrictive and may well lead to significant unnecessary repeat testing." Older data should not be ruled out "because it does not meet today's standards," P&G maintains.

The company is also working with an industry-government coalition to "develop the large databases needed to increase the predictive ability of toxicological effects based on the chemical structure or chemical properties of a material and...will continue to share [its] approaches broadly."