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EPA Announces Start of Voluntary Pilot Program to Reduce Animal Testing

On December 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.”

For this pilot program, EPA is requesting submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations; instruction for doing so are available on the GHS Equation Pilot Program webpage, and Guidance on the GHS Mixtures Equation is available in the Guidance on the Application of the CLP (Classification, Labeling and Packaging) Criteria.

The program is an interesting approach considering the conceptual differences of risk assessment and hazard determination that exist at the core of  EPA risk approaches and GHS fundamentals.  Also, the definition of the EPA Categories compared to GHS has been problematic for hazard communication applications. 

Mixture calculation tools rely on the availability of data for all components and would only be applicable if the data for each were generated using the same species under similar exposure conditions.  

This pilot program is being developed under EPA’s initiative to develop non-animal alternatives for acute toxicity testing, as well as EPA’s Office of Pesticide Programs’ Strategic Vision for Adopting 21st Century Science Methodologies.

©2019 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Karin F. Baron, Bergeson Campbell, Chemicals Regulation Lawyer, Industrial Hygiene Attorney
Senior Regulatory Consultant

Karin F. Baron, Senior Regulatory Consultant with Bergeson & Campbell, P.C. (B&C®) has more than 15 years' experience developing, implementing, and managing complex chemical regulatory compliance matters for some of the largest industrial and specialty chemical companies in the world. Her primary areas of practice include hazard and risk assessment and communication, industrial hygiene and environmental health and safety (EHS) programs, U.S. Food and Drug Administration (FDA) regulations pertaining to food contact materials, and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), including compliant safety data sheets (SDS).

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Margaret Graham, Environmental Science and Policy Paralegal, Bergeson Campbell Law firm
Paralegal

Margaret R. Graham (Maggie), a paralegal with Bergeson & Campbell, P.C. (B&C®), holds a Masters degree in Environmental Science and Policy, and has over a decade of paralegal experience, including eight years focused in federal regulatory law.  Her understanding of environmental policy and the administrative and legislative process involved in regulatory compliance makes her an invaluable resource to B&C staff and clients, who rely on her research, project management, and writing and editing skills to complete efficiently briefs, pleadings, and other documents.

202-557-3815