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EC Opens Consultation Period on EFSA Risk Assessment and Scientific Advice

Beginning on January 23, 2018, the European Commission (EC) opened a consultation period on the European Food Safety Authority (EFSA) risk assessment process (scientific advice).  The EC states it is seeking feedback on its process both as  a “follow-up to the commitments made by the Commission in reply to the European Citizens’ Initiative on glyphosate,” and in response to “citizens [that] have put into question the risk assessment based on studies provided by the industry and this in particular where the industry seeks an authorisation, e.g. for  pesticides, GMOs etc.”

The General Food Law Regulation established EFSA, an independent scientific agency, to provide the risk assessment component of its risk analysis principle; the other two components are risk management and risk communication.  EFSA provides its scientific opinions “which form the basis for the measures taken by the [European Union (EU)] in the food chain.”  The EC states the General Food Law Regulation “is the cornerstone of the EU regulatory framework covering the entire food chain:  ‘from farm to fork.’”  The EC is requesting feedback to help it “look into how [the EC] can improve the current system and to address citizens’ expectations about independence and transparency of the EU risk assessment system.”   The EC is specifically requesting views and experiences on the following:

  • The transparency and independence of the EU risk assessment system with respect to the underlying industry studies and information on which EFSA's risk assessment/scientific advice is based;

  • Risk communication; and

  • The governance of EFSA, in particular the involvement of the EU Member States (MS) in the EU risk assessment system.

To contribute, interested parties must fill out the online questionnaire available here.  All stakeholders and EU as well as non-EU citizens are welcome to contribute to this consultation.  The consultation period will close on March 20, 2018

Commentary

This Consultation is of significant interest to stakeholders, particularly in balancing the potential need for increased transparency with the need to protect confidential business information, trade secret information, and proprietary expensive data investments.  Decisions made by EFSA also could have a global impact on data protection, as any decisions made by EFSA to increase transparency could affect whether certain data can continue to be protected under other regulatory programs. 

Outside of the transparency issues that are receiving much attention of late, it is important to note generally that views about risk assessment policies across governments tend to be driven by underlying political disagreements, with support or criticism somewhat predictable depending on how the resultant decisions are “for or against” the view of an interested constituency. 

The transparency issue here should be considered not only on its own merits, but also within the controversy that surrounded the EU assessment approach for glyphosate, an herbicide which is widely used in production of genetically modified crops.  As a stalking horse for the EU debate about biotechnology crops, the EU glyphosate assessment has, for example, become embroiled as part of the glyphosate carcinogenic classification of the International Agency for Research on Cancer (IARC). The IARC review concluded that glyphosate is a “probable human carcinogen,” contrary to most other assessments done by the U.S., Canada, and some EU Member States.  Comments on the general EU risk assessment process can be expected to be intertwined with the perspective that any commenter has on the glyphosate assessment, even though the request is for public comment on the assessment process generally, and not only specifically about glyphosate. 

©2019 Bergeson & Campbell, P.C.

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Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
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Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

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James V. Aidala, Bergeson, Senior Government Affairs Consultant, Toxic Substances Lawyer
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Jim Aidala, Senior Government Affairs Consultant with Bergeson & Campbell, P.C. is a critical ally for any client addressing chemical policy, legislative, and related issues. He has been intimately involved with the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) legislative reauthorization and key regulatory matters for over two decades. Mr. Aidala brings extensive legislative experience on Capitol Hill and past experience as the senior official at the U.S. Environmental Protection Agency (EPA) for pesticide and chemical regulation, and provides clients with vital insights into not only relevant current policies of EPA and sister agencies, but also the way these policies have been or are likely to be formulated to help clients more successfully address regulatory matters. This unmatched wealth of experience allows him to explain, interpret, and predict EPA policies to help clients resolve or address their issues.

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Lisa R. Burchi, Toxic Substances Control Act Attorney, FIFRA Lawyer, Bergeson and Campbell, Law firm
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Lisa Burchi's work involves Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulatory matters. She has particular expertise in data compensation matters under FIFRA, the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Biocide Product Regulation (BPR), and Plant Protection Product (PPP) Regulation, and also counsels on matters related to California law, including Proposition 65 and the recent Green Chemistry Initiative/Safer Consumer Products Regulations. She delivers...

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