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 Lynn L. Bergeson and Carla N. Hutton

In a bit of a surprise announcement, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. The Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture, is short, but clear as to timetable and deliverables.

 

Last updated in 1992, and first rolled out in 1986, the Coordinated Framework is the blueprint for federal regulatory policy for ensuring the safety of products of biotechnology.  The Coordinated Framework is of significant interest to the agribusiness community as USDA and EPA regulate genetically modified crops and plant pests.  According to the New York Times, more than 90 percent of the corn, soybeans, and cotton grown in the U.S. have foreign genes inserted into the DNA to make the crops resistant to herbicides, insects, or both.  While acknowledging the Coordinated Framework is working as intended in ensuring the safety of biotechnology products, the OSTP was quick to note in their blog item “Improving Transparency and Ensuring Continued Safety in Biotechnology,” that “the complexity of the array of regulations and guidance documents developed by the three federal agencies with jurisdiction over biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.”

 

The goal of the update effort, according to the memorandum, is to ensure public confidence in the regulatory system, improve transparency, predictability, coordination, and efficiency in the regulatory system, and encourage and support innovation in the area of biotechnology and products of biotechnology.  According to the OSTP blog item:

 

  • “First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process.  This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.

 

  • Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology.  This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
  • Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology.  The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.”

 

According to the memorandum, the following elements will support the process to achieve these objectives:

 

  • Biotechnology Working Group Under the Emerging Technologies Interagency Policy Coordination Committee:  The Biotechnology Working Group will include representatives from the Executive Office of the President, EPA, FDA, and USDA.

 

  • Mission and Function of the Biotechnology Working Group:  Within one year of the date of the memorandum, the Biotechnology Working Group shall take steps detailed below and others, as appropriate, to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology.  The Working Group will:
    1. Update the Coordinated Framework to clarify the current roles and responsibilities of the agencies that regulate the products of biotechnology, after input from the public; and
    2. Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.

 

  • Independent Assessment:  EPA, FDA, and USDA shall commission an external, independent analysis of the future landscape of biotechnology products that will identify (1) potential new risks and frameworks for risk assessment, and (2) areas in which the risks or lack of risks relating to the products of biotechnology are well understood.  The review will help inform future policy making.  Due to the rapid pace of change in this arena, an external analysis should be completed at least every five years.

 

  • Budgeting for Efficiency:  EPA, FDA, and USDA shall work with OSTP and OMB, within the annual President’s budget formulation process, to develop a plan for supporting the implementation of this memo in agency fiscal year (FY) 2017 budget requests and, as appropriate, in future budget submissions.

 

  • Annual Reporting:  For at least five years, starting one year after the release of the strategy described above, the Biotechnology Working Group will produce an annual report on specific steps that agencies are taking to implement that strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products.  This report will be made available to the public by the Executive Office of the President.

 

A number of reports have .issued in the recent past calling for exactly what the Administration announced on July 2.  Last year, the Venter Institute issued a landmark analysis of the domestic biotechnology regulatory system in which it highlighted the critical need for modernizing the Coordinated Framework.  J. Craig Venter Institute.  Synthetic Biology and the U.S. Biotechnology Regulatory System:  Challenges and Options (May 2014).

 

More recently, the National Research Council of the National Academies issued, on March 13, 2015, Industrialization of Biology:  A Roadmap to Accelerate the Advance Manufacturing of Chemicals.  The report, prepared by the Board on Chemical Sciences and Technology, Board on Life Sciences, Division on Earth and Life Studies, identified the challenges and opportunities posed by the current regulatory system relating to biotechnology and synthetic biology.  

 

The Woodrow Wilson International Center for Scholars Synthetic Biology Project issued a statement praising the Administration’s decision:  “The Synthetic Biology Project supports the effort by the White House Office of Science and Technology Policy (OSTP) to update the Coordinated Framework for the Regulation of Biotechnology to address emerging technologies like synthetic biology.”  The statement goes on to say:  “We see this as a positive development and one that is long overdue considering the rapid advancement of biotech-related fields like synthetic biology.”

 

A forthcoming report from the Synthetic Biology Project examines the regulatory pathways of new applications that are close to entering the market.  That report finds confusion about the regulatory jurisdiction of different agencies in the framework and questions which statutes apply to the applications.  Earlier this year, the Project released an interactive, crowdsourced inventory to track applications and products that utilize synthetic biology techniques.

 

The memorandum is welcome news as the Coordinated Framework needs updating for all the reasons outlined in the reports noted above.  Despite the Framework’s inherent elasticity and nimbleness, the pace of innovation and complexity of new biotechnology products require a modernized, forward-focused framework.  


 

By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.


On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to develop draft Biological Evaluations (BE) for three pilot chemicals (chlorpyrifos, diazinon, and malathion) in response to the National Academy of Sciences’ (NAS) report “Assessing Risks to Endangered and Threatened Species from Pesticides.” The workshop was the fourth interagency workshop on this issue, and follows previously-held public meetings in November and December 2013, April 2014, and October 2014, and was held as part of the enhancement of the stakeholder engagement process finalized in March 2013. A copy of the Fourth ESA Stakeholder Workshop agenda is available online. The Interagency presentations are also available online.

This workshop presentations and discussion appeared to demonstrate progress among the agencies in coordinating their work to address the issues that have been the subject of this and prior workshops. The presentation content exhibited a better understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) evaluation process by the Services, and the presentations themselves allowed for more interaction between the presenters and participants; some of the question and answer sessions (conducted after each segment) included detailed exchanges of information among the participants.

To the dismay of some registrants and observers, however, as the various evaluation models were described, and an avian case study presented, the direction of the joint analyses seemed to be moving towards the marriage of very conservative EPA assessment models and assumptions with the Services’ desire to avoid any potential impacts on individual members of a protected species and any habitat. Should this direction not change, the Endangered Species Act pilot assessments could be very conservative and indicate what many may believe is an unwarranted need for significant changes in some current pesticide labels. Simply put, from a registrant perspective, the good news is that the agencies are cooperating and working better together; the bad news is that both EPA and the Services appear to be planning to use very conservative models and assumptions, which could result in proposals for severe restrictions on some current use patterns.