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By Pat Rizzuto
A new EPA list of automated chemical safety tests that manufacturers can use instead of laboratory animals when securing regulatory approval for their products will be reviewed Nov. 3.
The upcoming tests are in part the result of pressure animal welfare groups, some toxicologists, and others exerted while Congress amended a chemicals law. The law requires the Environmental Protection Agency to finalize a strategic testing plan by June 2018.
The plan will encourage the agency and chemical makers to use automated toxicity tests, computer models, and other methods to reduce, refine, or replace traditional reliance on rats, mice, rabbits, fish and other test animals. The challenge: to make the new tests as informative, or even more so.
Louis Scarano, a toxicologist in the EPA’s Risk Assessment Division, briefed an interagency committee’s scientific advisers Sept. 19 about the EPA’s progress in developing the plan, which they will unveil to the advisers Nov. 3.
Clear guidance and specific lists of approved tests would encourage chemical and drug companies to give regulators product safety data using animal-free tests, industry members of that advisory panel said Sept. 18 as they evaluated a broader cross-government plan to improve toxicity tests while reducing animal use.
“Agencies should articulate their expectations,” said panel member Hisham Hamadeh, director of safety sciences at Amgen, Inc., and other industry members agreed.
Chemical makers would like the EPA to offer guidance on when information from a cellular, genetic, or other new type of test shows a chemical has “substantial risk” that the company must promptly report, according to panel member Lawrence Milchak, a senior toxicology manager at 3M. Milchak referenced a substantial risk notification requirement in Section 8(e) of the Toxic Substances Control Act.
The EPA will present a draft plan Nov. 3 before the Interagency Coordinating Committee on the Validation of Alternative Methods meeting, Scarano said. Scientists from 16 federal agencies that require, use, generate, or disseminate toxicity and safety information participate in that committee.
The agency is scheduled to release its first draft plan for comment sometime between December and April, and finalize it by June 2018, Scarano said. In addition to the list of toxicity tests and chemical characterization methods, the EPA plan will include criteria such tests must have to prove they are reliable and relevant for their intended purposes, Scarano said.
The plan also must show how the EPA will phase-in testing requirements, so that chemical manufacturers would begin with simpler, quicker, cheaper tests before EPA would require more complex and expensive tests, some of which take years and cost millions of dollars.
TSCA requires that EPA show that the new types of toxicity tests would generate information that’s “equivalent or better” at predicting health and environmental injuries than the tests they replace.
Other challenging issues, such as how to use new types of tests for nanoscale chemicals, are likely to be dealt with in the future, Scarano said. The agency plans to train staff to understand and use new testing methods described in the plan, he said.
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An EPA summary of TSCA's requirements is available at http://src.bna.com/sFT.
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