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EDF Reports That EPA Has “Muzzled” SACC

The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.”  EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA),” including:

  • Excluding from its analysis known human and environmental exposures to a chemical, based on the assumption that those exposures are adequately managed by other statutes;

  • Claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of the Occupational Safety and Health Administration (OSHA) regulations that either do not apply or are out of date;

  • Arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and

  • Choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, instead making “questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.”

EDF states that through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or find risks that are low enough that it can impose few restrictions.  According to EDF, in response to each of these decisions, EPA received critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental non-governmental organizations (NGO), and members of the scientific community.  EDF reports that during the first several peer reviews conducted by EPA’s Scientific Advisory Committee on Chemicals (SACC), many of the SACC members raised similar concerns.  According to EDF, EPA has directed SACC “that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.”  EDF states that “[t]his is beyond the pale” for the following reasons:

  1. Such issues fall squarely within SACC’s charge.  EPA’s charge questions to SACC for its most recent peer review of 1-bromopropane (1-BP) “specifically (and appropriately) call on the SACC to comment on the ‘assumptions, uncertainties and data limitations in the methodology used to assess risks from 1-BP’”;

  2. It is “absolutely” SACC’s role and responsibility to comment on the scientific consequences of EPA’s decisions that directly affect its characterization of exposure, hazard, and risk; and

  3. With respect to the adequacy of the information on which EPA relies, EPA “has recently made an additional claim to the SACC:  that EPA has no choice but to use the data it has readily at hand, however limited they are.”

EDF concludes that EPA’s direction to SACC “is but the latest in a series of moves to limit the scientific information and scientific advice that EPA can obtain and use to make decisions.”

©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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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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