Berger, Votaw, and Gustafson in Bloomberg Article

Keller and Heckman Partners Tom Berger and James Votaw and Associate John Gustafson were quoted in the Bloomberg Law article, “Companies See Ambiguity in Animal Tests as Chemical Law Unfolds.” The article discusses how the Environmental Protection Agency (EPA) aims to reduce animal tests as required by the nation’s amended chemicals law. However, there’s a long way to go before the agency, or outside organizations, will be comfortable with new types of data that come from alternatives to those tests, trade association officials, attorneys, and nonprofit organizations say. 

The groups have been analyzing similarities and changes in the agency’s approach to getting toxicity, exposure, and other data since Congress amended the nation’s primary chemicals law, the Toxic Substances Control Act, in 2016. The requirement for more animal tests is likely to increase as the agency implements TSCA’s requirements on existing chemicals in commerce, said James. 

In 2016, soon after chemicals law was overhauled, almost all requests to make new chemicals “were met with a requirement to submit the results of a 90-day mammalian oral or inhalation toxicological study,” Tom said. Since then, “we have seen a trend towards requiring or suggesting that certain physical or chemical property tests be conducted prior to conducting mammalian studies.”

The EPA is trying to get comfortable with new chemical testing methods, but it may take some time for the EPA to get comfortable, said John. On the one hand, a policy the agency issued shows the agency’s interest, he said. That policy allows the use of non-animal tests that can determine whether a chemical would cause skin allergies.

Yet the agency’s proposed, broader strategy is largely aspirational, John said. It omits critical issues such as how much money it needs to implement the plan and how companies that have developed new testing approaches could get the use of those methods approved, James and John both said. 

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