Beveridge & Diamond
 

AgTech Regulatory Resource Center


B&D established this AgTech Regulatory Resource Center in light of federal agencies’ announcements starting in January 2017 proposing fundamental changes to the regulation of agricultural biotechnology products, genetically engineered organisms, and related research and development activities. 

We prepared this Resource Center to help companies monitor these key developments and plan for next steps. We post regular updates to this Resource Center as circumstances warrant, and we invite you to explore these materials and contact Kathy Szmuszkovicz or Alan Sachs at any time with questions or for further discussion.

IMPORTANT NOTE

February 1, 2017

The status of many draft proposals and guidance originally issued by the Obama Administration likely will remain uncertain in the near term. At a minimum, all earlier proposals will be subject to full review and possible reconsideration by the Trump Administration before they are finalized. In this vein, it is important to note that, on January 30, 2017, the Trump Administration ordered that at least two existing regulations be identified for elimination with each new regulation issued. B&D will continue to monitor federal administrative and legislative developments that may impact agency activities and update this Resource Center website as circumstances warrant.

 

Coordinated Framework for the Regulation of Biotechnology

(No developments since 3-9-17)

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine released its report on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System”. Commissioned in connection with the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, the new report provides an overview of developing plant, animal, and microbial technologies and recommends that federal agencies expand their scientific capabilities and levels of expertise in order to prepare for significant biotechnology product innovations anticipated over the next decade.    

On January 4, 2017, the U.S. Environmental Protection Agency, U.S. Department of Agriculture, and U.S. Food and Drug Administration released their final version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.

U.S. Department of Agriculture

(No developments since 6-28-18)

  • APHIS Announces Renewed Effort to Amend Regulation of Genetically Engineered Organisms

Following withdrawal of its January 2017 proposal to revise the regulation of genetically engineered organisms on November 6, 2017, APHIS is now relaunching its effort with publication of a notice of intent to prepare a new programmatic environmental impact statement (EIS), as required under the National Environmental Policy Act (NEPA).  APHIS explains that it seeks to address “advances in biotechnology” over the past 30 years and allow APHIS to more effectively protect plant health by focusing its regulations on the risks that may be posed by certain genetically organisms “rather than on the methods used to produce the products.”  APHIS also seeks to “make the regulatory processes more transparent while removing unnecessary regulatory burdens.”

Rather than identify any specific regulatory approaches now under consideration, APHIS’s notice broadly solicits comments from the public “to help APHIS further define the issues and alternatives that should be considered and to help APHIS identify additional impacts, both positive and negative, to the human environment that should be examined in the EIS.”

The deadline for comments will be July 30, 2018.

On May 3, 2018, the U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) announced its proposed bioengineered food disclosure standard.  Consistent with the federal mandate signed into law on July 29, 2016, the proposed National Bioengineered Food Disclosure Standard (NBFDS) establishes the first-ever nationwide labeling requirements for bioengineered food.  USDA is charged with finalizing its implementing rules by July 29, 2018, and is accepting public comments on its proposal for 60 days.

  • USDA Extends Comment Period for “Clean Meat” Labeling Petition

On April 13, 2018, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) extended by one month the comment period associated with the U.S.Cattlemen’s Association (USCA) petition requesting the exclusion of products not derived directly from animals that have been raised and slaughtered from the definition of “beef” and “meat.”  According to FSIS, the February 9, 2018 petition has generated “significant interest” from stakeholders.  Comments must now be submitted by May 17, 2018. 

On February 8, 2018, the United States Cattlemen’s Association (USCA) filed a petition with the United States Department of Agriculture (USDA) requesting that the Agency establish a food labeling requirement that the term “beef” only be used to refer to products that “come from cattle that have been born, raised, and harvested in the traditional manner.”  If USDA takes the requested action, manufacturers of new “clean meat” products would be prevented from labeling their products as “beef” or “meat.”  Industry stakeholders and other interested members of the public may submit comments on USCA’s petition until April 23, 2018. 

The term “clean meat” refers to products that are grown in cell cultures from animal stem cells (also called “cultured meat” or “synthetic meat”).  The processes for clean meat production have developed along with broader advances in tissue engineering, many in the medical field.   The petition does not directly address how USDA should view meat derived from cows or other livestock bred with any kind of genetic engineering or gene-editing techniques (i.e., CRISPR).  While these products are still under development and have not yet reached the market, industry stakeholders should consider the potential impacts of any USDA labeling policies for clean meat on food products that may be derived from gene-edited livestock in the years to come.

The petition and public comments may be reviewed here.

  • USDA Clarifies Position on Regulatory Status of Genome-Edited Plants

On March 28, 2018, U.S. Secretary of Agriculture Sonny Perdue issued a statement to clarify USDA’s position on the regulatory status of plants produced through genome-editing and other innovative breeding techniques. Consistent with responses to individual letters of inquiry by USDA’s Animal and Plant Health Inspection Service (APHIS) over the last few years, USDA’s statement confirms that the Agency does not currently regulate, or have any plans to regulate, plants “that could otherwise have been developed through traditional breeding techniques as long as they are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.” According to USDA, such techniques may involve plant varieties with the following changes:

  • Deletions—the change to the plant is solely a genetic deletion of any size.
  • Single base pair substitutions—the change to the plant is a single base pair substitution.
  • Insertions from compatible plant relatives—the change to the plant solely introduces nucleic acid sequences from a compatible relative that could otherwise cross with the recipient organism and produce viable progeny through traditional breeding.
  • Complete Null Segregants—off-spring of a genetically engineered plant that does not retain the change of its parent.

While such plants do not require regulatory oversight by USDA, the statement notes that EPA and FDA retain separate oversight authority of biotechnology products under the Coordinated Framework for the Regulation of Biotechnology.

  • APHIS Withdraws Proposed Revisions to Biotechnology Regulations

On November 6, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced the withdrawal of its January 19, 2017 proposal to revise the regulation of genetically engineered organisms.  According to the APHIS, it received 203 comments on the proposal, including many objections to its scope and concerns about the proposed risk assessment process.  In its announcement, APHIS indicates that it will begin “a fresh stakeholder engagement aimed at exploring alternative policy approaches,” while continuing to consider the comments received on the withdrawn rule.

On September 5, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced the launch of a new website tool to search biotechnology permit and notification data.  Previously, these data were available in various forms on the APHIS website and the Information Systems for Biotechnology (ISB) website separately maintained by Virginia Polytechnic Institute and State University (popularly known as Virginia Tech).  Beginning September 15, 2017, the ISB website will no longer contain data for biotechnology permits and notifications issued by APHIS; these data will be available exclusively on the APHIS website.

APHIS reports that it has increased its data-managing capability and is bringing this functionality in-house to increase government efficiency and enhance user experience.  The data, which were previously also available on the APHIS website but only in a downloadable spreadsheet format, will now be presented both as a downloadable spreadsheet and in a user-friendly searchable format.  With the new tool, users will be able to search data by institution, article, action, type, status, state, genotype, and phenotype, as well as by a global search field.  APHIS intends to continue to improve the site by providing improved search functions and visual representations of data in the near future.

  • APHIS Extends Comment Periods for Proposed Revisions to Biotechnology and Plant Pest Regulations

On February 10, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) extended the comment period associated with its January 19, 2017 proposal to revise the regulation of genetically engineered organisms by one month, to June 19, 2017. On February 13, 2017, APHIS similarly extended the comment period associated with its separately issued January 19, 2017 proposal to revise the regulation of plant pests by one month, to April 19, 2017.

On January 19, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) proposed major changes to its existing rules governing plant-based biotechnology. The proposal would represent the first comprehensive revision of APHIS’s biotechnology regulations since they were first established in 1987. Comments must be submitted by May 19, 2017. 

On January 19, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) proposed to substantially revise its regulations at 7 C.F.R. Part 330 governing the movement of plant pests. Comments on the proposed rule must be submitted by March 20, 2017.

U.S. Food and Drug Administration

(No developments since 3-27-18)

  • FDA Submits Proposed Collection of Information for Biotechnology Consultations

On March 27, 2018, the U.S. Food and Drug Administration (FDA) announced the submission of a proposed collection of information in connection with its longstanding voluntary consultation process for foods derived from plant-based biotechnology.

Under the Paperwork Reduction Act, every federal agency must obtain approval from the Office of Management and Budget (OMB) before collecting certain information (including reports, applications, and plans) from ten or more members of the public. Ongoing collection activities like FDA’s biotechnology consultation process must be approved by OMB at least once every three years.

FDA’s voluntary consultation process (first outlined by FDA in a 1997 guidance document) is intended to allow producers who use biotechnology in the manufacture or development of foods and food ingredients to work cooperatively with FDA to ensure that products derived through biotechnology are safe and comply with all applicable legal requirements.

FDA announced an initial opportunity to comment on the proposed information collection associated with this process on December 13, 2017. According to FDA, it received two comments, both of which were supportive of the Agency’s need for the information collection. Accordingly, FDA has proposed retaining the previously approved annual reporting burden (1,960 hours) estimate associated with the consultation process.

Comments on FDA’s proposal may be submitted directly to OMB until April 26, 2018.

On October 4, 2017, the U.S. Food and Drug Administration (FDA) issued final guidance clarifying that mosquito-related products intended to control mosquito populations are regulated by the U.S. Environmental Protection Agency (EPA), while FDA has jurisdiction over products intended to reduce the virus/pathogen load within a mosquito or prevent mosquito-borne disease.  See Guidance for Industry #236.   This final guidance closely tracks, and is in most respects identical to, the draft version that FDA distributed for public comment on January 18, 2017. 

  • FDA Extends Comment Periods for Proposed Guidance on Genome-Edited Animals and Docket Seeking Input on Approach to Genome-Edited Plants

On April 12, 2017, the U.S. Food and Drug Administration (FDA) announced extensions of the comment periods associated with its draft guidance document on genome-edited animals (Guidance for Industry #187, proposed on January 18, 2017) and its separate docket requesting input on FDA’s regulatory approach to human and animal foods derived from plants developed using genome editing (opened on January 19, 2017). Both comment periods will now close on June 19, 2017.

On January 19, 2017, the U.S. Food and Drug Administration (FDA) established a docket to receive comments on the use of genome-editing techniques to produce new plant varieties that are used for human or animal food. Comments are due by April 19, 2017. 

On January 18, 2017, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents that, if adopted, would clarify how FDA intends to regulate biotechnology and mosquito products under the agency’s new animal drug (NAD) authority. The first, Guidance for Industry # 187: Regulation of Intentionally Altered Genomic DNA in Animals, revises previous FDA guidance that applied solely to genetic modifications achieved using recombinant DNA (rDNA) technology. The second document, Guidance for Industry # 236: Regulation of Mosquito-Related Products, specifies the circumstances under which FDA would regulate products that affect or modify mosquitoes and when FDA will defer to the authority of the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Comments on the draft Guidance for Industry # 187 are due on April 19, 2017.  The public may also comment on FDA’s draft mosquito product guidance through February 21, 2017. 

U.S. Environmental Protection Agency

  • No Updates 

AgTech Practice Team

 

Editor

Alan J. Sachs

Principal

(212) 702-5445

asachs@bdlaw.com

 

Kathryn E. Szmuszkovicz

Principal

(202) 789-6037

kes@bdlaw.com

   
 

K. Russell LaMotte

Principal

(202) 789-6080

rlamotte@bdlaw.com

   
 

James M. Auslander

Principal

(202) 789-6009

jauslander@bdlaw.com

   
 

Andrew C. Silton

Associate

(202) 789-6078

ASilton@bdlaw.com

 

Beveridge & Diamond's reputation for excellence in agricultural biotechnology law and regulation is based on forty years of working with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use conventional pesticides, pesticides produced through biotechnology, and other chemical and biotechnology products. We represent both large and small companies, as well as task forces of companies, with an emphasis on entities that invest in research to discover, develop, and defend new technology.  We work with each client to identify its business objectives, and then to establish and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives. To learn more, please contact Kathy Szmuszkovicz (kes@bdlaw.com, (202) 789-6037), Alan Sachs (asachs@bdlaw.com, (212) 702-5445), or any member of our Pesticides and Biotechnology practice groups.