SPECIALTY CROP REGULATORY ASSISTANCE WORKSHOP II: NUTS AND BOLTS OF US REGULATORY DOSSIERS FOR GENETICALLY ENGINEERED PRODUCTS

Target Audience
The attendees at the regulatory workshop included university personnel, many small companies, regulatory consultants and government agency representatives. The workshop included approximately 50 individuals. Workshop participants had the opportunity to spend two days with regulatory officials from the 3 agencies with jurisdiction over GE products (USDA-APHIS, FDA, and EPA) and learned the specifics of putting together dossiers for regulatory approval. The majority of the workshop focused on actual case studies (i.e., dossiers of actual approved GE products and of GE products poised to enter or complete the regulatory process). Of the 38 attendees: 14 goverment representatives from USDA, FDA and EPA 8 consultants 9 SMEs 1 large company 6 academic

Changes / Problems
Nothing Reported

Training & Professional Development
Three agencies, USDA APHIS, EPA, and FDA presented general information on the desires of each agency for data that would be important for informing a decision on the transgenic plant. The Coordinated Framework and USDA APHIS BRS Sally McCammon (USDA) and Mike Mendelsohn (EPA) presented an overview of the Coordinated Framework (CF). The Office of Science and Technology Policy in 1986 declared that using genetic engineering to produce new phenotypes was not substantially different from other types of technology. All regulations should be based on science on a case-by-case basis. Statues (the laws) on the books were sufficient to regulate the products of the new technology. Four major acts of law govern the regulatory code: Plant Pest Act (PPA) USDA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) EPA Toxic Substances Control Act (TSCA) Federal Food, Drug, and Cosmetics Act (FFDCA) FDA Regulations are the implementation of the laws in order to comply with the law. These are written by the agencies, posted for public comment and revised based on comment. Guidance is offered by the agencies to assist producers to comply with the regulations. Department of Agriculture (USDA-APHIS): Plant Protection Act (PPA): Protecting against damage from plant pests and noxious weeds Environmental Protection Agency (EPA): Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA): Regulating the safe use of pesticides; and Federal Food Drug and Cosmetic Act (FFDCA): Tolerance actions for pesticide residues on food and feed products Food and Drug Administration (FDA): Federal Food, Drug and Cosmetics Act (FFDCA): Safe use of GE organisms in food and feed products USDA APHIS Dr. Mike Mendelssohn reported on the effort to modernize the CF. Three workshops were scheduled seeking public input at White Oak MD; Dallas TX; and Davis CA. The update was announced in the federal register with the goals of reducing unpredictability of the regulatory process, to make it entirely science-based, and to promote public confidence in the system. The agencies are developing a long-term strategy for the future of biotechnology products. The update will also clarify the current roles and responsibilities of each of the agencies. It was open for public comment at the time of the workshop (September, 2016). Dr. John Turner, USDA APHIS, discussed the experience of APHIS in the regulation of biotechnology-derived plants. In the nearly 30 years of looking at these products, the agency has authorized over 100,000 field releases and granted non-regulated status to 120 petitions representing 17 species. Triggers for regulatory oversight include: The organism has been altered or produced through genetic engineering (recombinant DNA techniques), and The organism is produced using plant pests (i.e. donor, recipient, or vector is a plant pest) or There is otherwise a reason to believe that the organism is a plant pest. Not all organisms produced using modern biotechnology techniques are regulated. Environmental Protection Agency Chris Wozniak from EPA presented the agency process for plant-incorporated protectants (PIPs). A PIP is a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof." (40 CFR Sec. 174.3) Developers are encouraged to consult early and often with EPA on new plant varieties with PIPs. Once a product is registered with EPA, maintenance fees are required for continued registration. EPA is implements regulations for 4 laws: Federal Insecticide, Fungicide and Rodenticide Act -(FIFRA) pesticides; Federal Food Drug and Cosmetic Act - (FFDCA) food and feed safety; Food Quality Protection Act ? (FQPA) amends FIFRA and FFDCA to include sensitive groups; Endangered Species Act ? (ESA) any impact on threatened or endangered species. FIFRA is a risk benefit act where risk equals hazard X exposure. EPA analyzes data for PIPs at 3 levels: product characterization, effects on human health, and effects on the environment. Food and Drug Administration Patrick Cournoyer, Center for Food Safety and Applied Nutrition and Office of Food Additive Safety, gave an overview of the FDA process for evaluating new plant varieties used in food. Within the coordinated framework, the FDA applicable laws governed 1) endogenous substances--to ensure sufficient nutrition and to ensure that added substances must not be at harmful levels, and 2) new ingredients including those added through biotechnology--must meet established safety criteria. In 1992, the agency supported labeling that was truthful and not misleading. Any developer of a biotechnology-derived plant product is encouraged to do a consultation with the FDA to determine if safety concerns will exist. In some instances, food items or additives can be considered GRAS--Generally Recognized as Safe. Among experts qualified by scientific training and experience to evaluate their safety, these ingredients have been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. Safe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not be harmful under the intended conditions of use. (Code of Federal Regulations 170.3(i)) The same considerations apply to food products produced through biotechnology. Data and information that FDA evaluates are based on the FD&C Act and it is important to consult with FDA to resolve safety and regulatory questions before marketing. Topics include endogenous substances, added substances and/or labeling. The developer will submit a safety and regulatory assessment to the FDA. An FDA team of experts will review the data and information and request additional information as needed. This process is repeated until the FDA is satisfied that the data set is complete, i.e., until all safety and regulatory questions are resolved. Then the FDA will summarize the evaluation in a memo and send a letter to the developer that states they have no more questions. The FDA encourages meeting with them early and often when developing a product that may enter the food supply. This can be in person or by teleconference. It is at no cost to the crop developer. Each of the presenters and attendees gained information on how to submit a dossier on a biotechnology crop--at least the general approach. They also learned that each crop dossier is unique and that they should consult as often as possible with the regulatory agenices to make the process efficient for themselves and the agencies

Dissemination Streams
Publication of the conference proceedings is in progress. A report was written and is being formatted for submission to Nature Biotechnology.

Next Reporting Steps
Nothing Reported

Target Audience
Preparations are being made for the workshop to be held September 19-21 in Washington D.C. The audience will be developers of biotechnology regulated crops from small and medium sized companies, government labs, academic labs, and consultants. We will have 3 Case studies presented during the workshop. The 3 case studies to be presented are as follows: 1. Citrus Tree Defensin Protein, developed by Mike Irewy with Southern Garden Citrus 2. Blight-resistant potato with reduced acrylamide potential, developed by Susan Collinge with J.R. Simplot, and 3. Ultra-low Gossypol Cottonseed, developed by Keerti Rathore at Texas A&M University The workshop agenda is set up to allow each regulatory agency to present an overview of the regulatory process and the Coordinated Framework followed by questions and answers with time for discussion. Case studies will be presented by the developer of each trait giving an overview of the project followed by presentations from each regulatory agency. In order to allow the regulatory agencies the ability to address each case study in a relevant manner, we have provided them with the case study abstracts in advance. After the developer has presented and each regulatory agency has responded we have scheduled an hour for Q & A's and discussion for each case study. The agenda also includes a working lunch to allow participants to make connections with regulatory agency officials, regulatory consultants participating in the workshop, and other developers. Detailed information, including the workshop agenda, can be found by visiting www.specialtycropassistance.org

Changes / Problems
The only change we made is in the projected date of the workshop. We intended to do this in spring, 2016, but the logistics did not work out and the September date was chosen. Because of this, a no cost extension was requested and granted.

Training & Professional Development
Each of the presenters and attendees will learn how to submit a dossier on a biotechnology crop--at least the general approach. They will also learn that each crop dossier is unique and that they should consult as often as possible with the regulatory agenices to make the process efficient for themselves and the agencies.

Dissemination Streams
Nothing Reported

Next Reporting Steps
We will conduct the workshop, write up a summary of the workshop, and Infinite Eversole Strategic Crop Services will follow up with any attendees that are interested in pursuing deregulation of their biotechnology crop. <br><br>