Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Sheryl Lindros Dolan and James V. Aidala

The Appropriations Bill that is expected to be signed into law on February 15, 2019, provides funding for the rest of Fiscal Year (FY) 2019 and averts another federal government shutdown.  It does not, however, include either an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or Reauthorization, widely referred to as PRIA 4.  This omission was a surprise to industry and to the U.S. Environmental Protection Agency (EPA).  On February 13, 2019, the Senate introduced a stand-alone PRIA 4 bill (S. 483).  Acting swiftly, the Senate passed the bill on February 14, 2019, by unanimous consent.  S. 483 directly references H.R. 1029, the Pesticide Registration Enhancement Act of 2017, from the last Congress, with amendments passed by the Senate on June 28, 2018.  

S. 483 has moved to the House, where the timing of a vote currently is unclear.  The House will go into a week-long recess after today.  It is possible that the bill will not further progress until the House reconvenes on February 25, 2019. 

The effect on EPA and the regulated community during this transition is also unclear.  Currently, EPA is sorting out applications and PRIA deadlines along with workload planning in the aftermath of the recently concluded federal government shutdown.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides for a reduction in applicable fees if PRIA is not reauthorized, but it is unclear if applications submitted during the transition will be assigned a PRIA review date.  If PRIA 4 is passed, we expect that the fee provisions will be retroactive and that EPA will send invoices to applicants for submissions made during the transition period for the difference between what was paid and the new PRIA 4 fee. 

More information on these topics is available in our blog items "Federal Budget Deal Negotiations Fail to Advance PRIA Reauthorization" and "Continuing Resolution to Re-open the Government Includes PRIA Extension."


 

By Lynn L. Bergeson and Carla N. Hutton

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.”  Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.”  To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.”  EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities.  In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products.  When completed, the agencies will consider the study’s findings, as well as the comments.  More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology