By Sheryl L. Dolan and Barbara A. Christianson
On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. Developers of certain genetically modified organisms may use the RSR process to determine the regulatory status of the organisms. The draft guide is open for public comment for 60 days. APHIS also will host a webinar to provide an overview of the draft RSR guide.
On May 18, 2020, APHIS published revised biotechnology regulations, codified in 7 C.F.R. Part 340 and referred to as the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. For a discussion of the SECURE rule, please review Final SECURE Rule Will Update and Modernize USDA's Biotechnology Regulations. The revised regulations identify high-level information requirements for submissions to support RSR requests. In response to comments on the proposed SECURE rule, APHIS stated that it would publish detailed information requirements as a draft guide for public comment prior to issuing the draft guide in final.
The draft RSR guide is available on the APHIS website, at the bottom of the tab labeled The Regulatory Status Review Process, and also in the online docket. The public may submit comments at https://www.regulations.gov/docket/APHIS-2021-0062. APHIS states that it will consider all comments received by October 25, 2021, prior to issuing the final RSR guide. Additionally, APHIS will host a technical webinar on September 21, 2021, to discuss the RSR process and guide, and provide stakeholders the opportunity to ask questions. Registration is available now on the APHIS website.
APHIS is authorized by the Plant Protection Act to evaluate potential plant pest risks resulting from certain organisms developed using genetic engineering techniques. Prior to the SECURE rule, developers of genetically modified plants could petition APHIS to seek a determination that a modified plant is unlikely to pose a plant pest risk and therefore is no longer subject to APHIS’ biotechnology regulations. With the SECURE rule, APHIS made several changes to its procedures, including introduction of the RSR process. The RSR process was implemented for select crops on April 5, 2021, and will be fully implemented for all crops on October 1, 2021.
Developers must submit a significant amount of technical information to APHIS to support a determination that a genetically modified plant can be deregulated. It typically is welcome news when regulators clarify the information that they need to make a regulatory determination, particularly given the time and resources invested in a new technology. A clear regulatory process, including information requirements and review timelines, allows industry to plan accordingly. The APHIS draft guide addresses information requirements, the review process, decision timelines, confidential business information justifications, and key definitions, and provides an optional submission template. It appears to be a useful tool in planning an RSR submission. We urge developers of genetically modified plants to review the guide carefully. If, following review, there are issues that require additional clarification, developers should highlight those issues in comments submitted to the docket linked above.
By Heather F. Collins, M.S. and Barbara A. Christianson
On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment. 85 Fed. Reg. 70146.
EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service, develops and implements programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance. According to EPA, the list serves as a tool for private and public organizations, including local or state governments, departments of public health, pesticide registrants, and non-governmental organizations, when making decisions and plans about future public health actions.
Since this list’s original publication in 2002, new vector-borne diseases have been identified and pests that had been previously thought of as benign or nuisance pests have been found to impact adversely public health. EPA, CDC, and USDA collaborated to update the list to incorporate significant changes regarding vector-borne diseases and related research, and eliminate gaps or ambiguities in the current pests list.
EPA states in the notice that the draft Pesticide Registration (PR) Notice 2020-X more precisely describes both the pests and expected public health impacts and adds several new pests (the brown dog tick) and public health impacts (Zika fever and coronaviruses like SARS-CoV-2) and that other pests have been renamed or grouped with similar species or removed altogether (hobo spider).
Draft PR Notice 2020-X describes the groups of pests and their potential impact on public health as follows:
- Arthropods: The listed arthropods may cause asthma or trigger allergies, contaminate food, irritate skin, cause direct injury, or carry diseases such as epidemic typhus, trench fever, epidemic relapsing fever, malaria, encephalitis (St. Louis, Eastern, Western, West Nile, and LaCrosse), yellow fever, dengue fever, and many others.
- Vertebrates: The listed organisms have the potential for direct human injury and can act as disease reservoirs for rabies and other diseases. The rats and mice include those that spread rodent-borne diseases and contaminate food for human consumption.
- Microorganisms and acellular particles: This category includes listed bacteria, fungi, protozoans, viruses, virusoids, and prions. The microorganisms and acellular particles listed in this category cause diseases such as COVID-19, cholera, meningitis, Legionnaire’s Disease, and many others.
The complete list of pests is identified in draft PR Notice 2020-X in Appendix A.
EPA states that the list does not affect the regulatory status of any registration or application for registration of any pesticide product.
Comments on the draft PR Notice are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2020-0260.
By Timothy D. Backstrom
On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products. This “one-stop-shop” website was created under the direction of Executive Order (EO) “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”
EPA regulates biotechnology-based pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and residues from such pesticides under the Federal Food, Drug and Cosmetic Act (FFDCA). EPA also regulates under the Toxic Substances Control Act (TSCA) certain new microorganisms that are not subject to regulation under other statutes. USDA regulates certain new biotechnology products under the Plant Protection Act (PPA), including agricultural crops that have been modified to be resistant to conventional pesticides. FDA regulates the safety of human and animal foods produced using biotechnology, including genetically modified agricultural crops and animals, and the safety of drugs and human biologics produced with biotechnology, under the FFDCA.
The website, The Unified Website for Biotechnology Regulation, describes the federal review process for biotechnology products, outline’s each agency’s role in regulating biotechnology products, and allows users to submit questions to the three agencies. EPA Administrator Andrew Wheeler states that the new website “will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace.”
In recent years, a number of Non-Governmental Organizations (NGO) have raised concerns regarding the risks from products that have been genetically modified using biotechnology, including agricultural crops that have been genetically modified to improve pesticide or disease resistance, and agricultural animals that have been genetically modified to enhance food production. In some instances, farmers have also expressed concern that crops with novel traits may exchange genetic information with other plant strains or species. Implicit in all of this criticism is a presumption that the agencies with regulatory jurisdiction over these novel organisms have not adequately prevented or mitigated the risks associated with biotechnology.
In contrast, proponents of biotechnology have complained that regulatory requirements imposed by the responsible agencies have stifled useful innovation and have requested relief from regulatory requirements that they contend have impeded or slowed introduction of new products of agricultural biotechnology. The Executive Order that underlies the new website seeks to streamline the administrative process for introducing novel agricultural products without increasing potential risks of biotechnology.
Additional information on how EPA regulates biotechnology products is available here.
By James V. Aidala and Susan M. Kirsch
On October 31, 2019, as required by the 2018 Farm Bill, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service published its interim rule, “Establishment of a Domestic Hemp Production Program” (Interim Rule). The Interim Rule proposal specifies rules and regulations governing hemp production in the U.S., including:
- Requirements for state/tribal plans for states pursuing regulatory authority over hemp production;
- Recordkeeping requirements;
- Licensing requirements;
- Delta-9 tetrahydrocannabinol (THC) testing;
- Procedures for disposing of non-compliant plants; and
- Compliance provisions and procedures for handling violations.
The Interim Rule does not alter the federal definition distinguishing hemp from marijuana, a distinction hinging on the levels of THC in the plant. Plants containing 0.3 percent or less THC on a dry weight basis are considered hemp, while plants exceeding this level of THC are marijuana. The Interim Rule introduces the term “acceptable hemp THC level” to account for a degree of uncertainty in testing results and explains how to interpret lab results with a measurement of uncertainty. This is a critical clarification given that THC levels dictate whether a grower is engaged in the legal production of hemp or is growing marijuana -- prohibited federally and in the majority of states.
The USDA is not proposing a single uniform testing method and will accept numerous testing methods and protocols employed by states. The Interim Rule does not include a federal seed certification program. The Interim Rule makes clear that interstate transport of hemp is permissible regardless of whether the states the shipment passes through allow hemp production.
The publication of the Interim Rule initiates USDA’s implementation of the hemp program, which includes reviewing state/tribal plans and issuing licenses. USDA will accept public comments on the Interim Rule for 60 days through December 30, 2019. Within two years of publication, USDA will publish a final rule. Also relevant for hemp producers are forthcoming proposals from the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency (EPA) addressing the sale of cannabidiol (CBD) and pesticide approvals for application to hemp plants, respectively.
For some, federal policies facilitating hemp production not only is a long-awaited policy goal, but a kind of “gateway drug” (pun intended) for renewing the debate about approval for pesticide products to be used on the legal production of marijuana crops.
To date, the federal government position is that since marijuana production is not allowed under federal law, attempts by states to permit pesticides for state use are forbidden. Some states have argued that since their state law allows the production of marijuana crops, pesticide products should be subject to registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency use or FIFRA Section 24(c) special local needs.
Separate from any debate about marijuana production, residues of pesticides on hemp products intended for human consumption, such as CBD products, will force EPA to consider how such products should be reviewed. Those policies, in time, will be relevant to any eventual evaluation of similar exposure and risk assessment questions regarding approval of pesticide products to be used in marijuana production.
By Lynn L. Bergeson and Margaret R. Graham
On October 25, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and OPP, will be holding two public meetings to discuss FDA’s Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North Carolina on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST). EPA states that this initiative, which Congress appropriated three million dollars to fund, “calls for FDA to work with EPA and USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology, and the purpose of the meetings is “to provide the public an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.” FDA issued a notice on these public meetings in the Federal Register on October 13, 2017. 82 Fed. Reg. 47750. More information on the initiative and how to register for the meetings is available on FDA’s website. Participation is available in person or by webcast.
In the notice, FDA also invites comments and responses to the following questions specifically regarding agricultural biotechnology and biotechnology-derived food products and animal feed:
- What are the specific topics, questions, or other information that consumers would find most useful, and why?
- Currently, how and from where do consumers most often receive information on this subject?
- How can FDA (in coordination with USDA) best reach consumers with science-based educational information on this subject?
Comments can be filed in Docket No. FDA-2017-N-5991 on www.regulations.gov; comments are due by November 17, 2017.
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.
By Lisa M. Campbell and Lisa R. Burchi
The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016. A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use,” is discussed in our blog item EPA Solicits Comments on Updated Method for Establishing Economic Minor Use.
In the notice extending the comment period, EPA noted that the current comment period is “one of the busiest times of year for pest control experts” and provides an extension that “will allow them extra time to complete their review and comment on the PR Notice.”
There is one comment that already has been submitted by the U.S. Department of Agriculture (USDA), which EPA stated it consulted prior to releasing the draft PRN 2016-X. In its comments, USDA states:
- Regarding acreage cutoffs, USDA supports EPA’s use of acreage estimates from the USDA Agricultural Census, as it is the “most reliable and comprehensive public source for such information in the country.”
- Regarding EPA’s proposal to apply a seven percent discount rate, USDA recommends that EPA be “open to using supplemental information in determining whether or not an alternative discount rate should be considered.”
- Regarding EPA’s proposal that all cases be evaluated using values for costs that range from 60 to 85 percent of gross revenue, USDA requests that EPA provide its rationale as to why this range was chosen. USDA states: “Although USDA understands that EPA is attempting to reveal the ratio of gross revenue to cost associated with the minor use rather than across an entire company, one could assume that a rational company would not pursue registering a minor use if the ratio of costs to gross revenue was exceedingly higher than the average standard ratio for the company. Qualitative information, as suggested by EPA, could then be used to further refine the estimate for this ratio.”
- Regarding EPA’s proposal to use study cost estimates provided by independent laboratories, USDA notes there are instances where data can be significantly more expensive than what would be expected generally and, thus, recommends that EPA “be open to additional, verifiable data a registrant wishes to submit that may indicate that its cost of data generation differs from EPA's standard estimates.” USDA also suggests that EPA “consider making the cost estimates it is using for individual tests available publically to aid registrants in determining whether or not they need to submit alternative incurred costs for studies they have conducted.”
By Lynn L. Bergeson and Margaret R. Graham
On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products." The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas. The third public meeting will be held on March 30, 2016, at the University of California, Davis Conference Center in Davis, California. Additional details on meeting times, agendas, and how to participate will be announced in a forthcoming Federal Register notice.
The July 2, 2015, memorandum was jointly issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality, and directs 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 (Coordinated Framework). The memorandum also directs the federal agencies to develop a long-term strategy to ensure that the regulatory system for biotechnology products is prepared for future products, and commissions an expert analysis of the future landscape of biotechnology products. Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology and describes the federal regulatory policy intended to ensure the safety of biotechnology products.
The first public engagement session took place on October 30, 2015, at the FDA’s White Oak Campus in Silver Spring, Maryland. Opening remarks were given by John Holdren, Ph.D., Assistant to the President for Science and Technology and Director of OSTP. Roberto Barbero, Ph.D., Assistant Director for Biological Innovation at OSTP, gave an overview on what OSTP is doing and how, as well as the principles that have led up to OSTP’s current efforts. Representatives from USDA’s Animal and Plant Health Inspection Service, EPA, and FDA also delivered statements on the federal regulation of biotechnology products. Interested parties in attendance included a number of non-governmental organizations that spoke out against the use of biotechnology, academic institutions that were supportive of continued research, and industry participants that were supportive of reasonable risk-based regulation to oversee biotechnology’s continued growth. A transcript from the meeting is available online.
More information regarding the Coordinated Framework is available in our October 6, 2015, memorandum OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and in our July 6, 2015, memorandum White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology.
By Kathleen Roberts
On November 19, 2015, the USDA published Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational process, and member responsibilities of the AC21; update committee members on relevant regulatory developments, initiatives, and USDA activities; and to outline new tasks for the committee to address. There will also be an opportunity for members of the public to make oral statements, as long as they contact Dr. Michael Schechtman (contact information below) about presenting a statement at least three business days before the meeting. The meeting will be held in Washington, DC on December 14 and 15, 2015, from 8:30 am to 5:00 pm both days.
By Lisa M. Campbell and Lisa R. Burchi
On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), announced in the Federal Register a public meeting to be held on October 30, 2015, to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework).
The meeting is intended to discuss FDA’s role in responding to the July 2015 memorandum issued by the OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled “Modernizing the Regulatory System for Biotechnology Products,” and will invite oral comments from interested parties. The July 2015 memorandum and the October 6, 2015, OSTP-issued Request for Information (RFI) to solicit relevant data and information to update the Framework are discussed in our memorandum Biotechnology: OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology.
The Executive Office memorandum directs FDA, EPA, and USDA -- the three agencies responsible for regulating biotechnology products -- to:
- Establish a working group to update the Coordinated Framework to clarify roles and responsibilities, and
- Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess any risks 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.
This meeting is another important step in the process to update the Framework, first issued in 1986 and last updated in 1992, to reflect better promising technologies routinely entering the market and, as the July 2015 memorandum provides, “to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.” Companies with biotechnology interests should monitor and participate in this process as appropriate, given its potential impact on the industry.
The meeting will be held on October 30, 2015, from 9:30 a.m. to 1:00 p.m. (EDT) at FDA’s White Oak Campus, Building 31 Conference Center, the Great Room, 10903 New Hampshire Avenue, Silver Spring, Maryland. Registering early is recommended due to limited space. The deadline for written comments is November 13, 2015.
For more information or to register for this meeting, visit FDA’s website.