April 4, 2019
EPA Releases Draft Guidance For Pesticide Registrants On Plant Regulator Label Claims, Including Plant Biostimulants
On March 25, 2019, the U.S. Environmental Protection Agency (EPA) finally weighed-in on the murky and often misunderstood topic of label claims for plant regulators and plant biostimulants in posting its Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. EPA states that the draft guidance, issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA, thereby subjecting the products to regulation as pesticides under FIFRA. EPA notes that when determining whether a plant biostimulant may trigger pesticide registration requirements, or may be excluded or exempt from FIFRA regulation, a “key consideration is what claims are being made on product labels.” Comments on the draft guidance are due by May 28, 2019.
Please see the Bergeson & Campbell, P.C. (B&C®) full memorandum for more information on this draft guidance including some background, information on the definition of a plant biostimulant, examples of product label claims, and B&C’s commentary.
FDA Highlights Advances In Animal Biotechnology Product Development
On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers, patients, and U.S. trading partners. In his published statement, Dr. Gottlieb emphasizes FDA’s ongoing implementation of the Action Plan, particularly on intentional genomic alterations in animals. Using genetic engineering and genome editing technologies, these innovations are providing additional clarity about how FDA’s regulatory framework works and should continue to work. A key part of the Action Plan’s implementation involves FDA’s Center for Veterinary Medicine’s Innovation Program, which provides sponsors with innovative products based on genomic alterations in animals to benefit from early feedback and guidance.
In the released statement, Abram further highlights the impacts of intentional genomic alterations in animals on human health. DNA editing not only benefits animals by halting animal-to-animal transmission of diseases, but also has the potential to benefit humans. According to Abram, FDA has already evaluated and approved several intentional genomic alterations in animals that produce drugs used to treat human diseases, advance the studies of new drugs, as well as human organ and tissue transplants. The Commissioners state that by ensuring safety of intentional genomic alterations to animals and animal-derived foods, FDA will continue to evaluate the effectivity of these alterations based on the totality of evidence provided rather than from any one particular assessment or result.
On April 25, 2019, FDA’s Center for Veterinary Medicine and the Center for Biologics Evaluation and Research will host a live webinar to discuss policy changes that may improve the Action Plan framework.
USDA APHIS Requests Public Comments On dEA And dPPRA Draft Documents
On April 3, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a request for comments on two documents related to the potential deregulation of a canola variety genetically engineered (GE) to convert oleic acid to docosahexaenoic acid (DHA) and eicosapentaeonic acid (EPA), as well as for resistance to an imidazolinone herbicide. The documents are a draft Environmental Assessment (dEA) and a draft Plant Pest Risk Assessment (dPPRA). While the dEA analyzes potential issues and environmental impacts, the dPPRA examines any plant pest risks. DHA and EPA are omega-3 fatty acids that support brain development and protect neurological function. The aforementioned GE canola accumulates higher concentrations of these fatty acids. Therefore, in a petition submitted by BASF Corporation (BASF), it stated that this canola provides a plant-based and scalable production system for omega 3-fatty acids that can be another source of EPA and DHA for consumers either as a food ingredient or as an aquaculture feed ingredient. Based on BASF’s statement and the draft documents, USDA will be accepting comments until May 6, 2019. APHIS intends to thoroughly review and consider the information provided in the completion of the final environmental documents and regulatory determinations.
Nouryon Announces “Weightless” Hair Styling Biobased Polymer
On April 2, 2019, Nouryon, a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the launch of a new biobased polymer for “weightless” hair styling. The newly developed biobased polymer, called Amaze SP, assists formulators to meet the latest trends in hair styling, which include lighter textures. Amaze SP is plant-based and part of Nouryon’s efforts in expanding its offerings to customers in the personal care market, which also includes a recently developed film-forming polymer for use in high SPF sunscreen products.
Check Out BRAG At ABLC 2019!
Hosted by Biofuels Digest, the Advanced Bioeconomy Leadership Conference (ABLC) will take place in Washington, D.C. at the Mayflower Marriot Hotel from April 3-5, 2019. BRAG and B&C are proud sponsors of this event and encourage interested parties to register. B&C’s Director of Chemistry, Richard E. Engler, Ph.D., will be moderating the Regulatory Workshop session on April 3, 2019, at 5:10 p.m. (EDT).
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The Biobased and Renewable Products Advocacy Group (BRAG®) helps members develop and bring to market their innovative biobased chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.
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