By Lynn L. Bergeson and Sheryl Lindros Dolan
On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology. The notice was published in the Federal Register on October 5, 2017. 82 Fed. Reg. 46500. Guidance for Industry #236, “Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products” (Guidance), provides information for industry and other stakeholders regarding the regulatory oversight of articles, including substances, for use in or on mosquitoes (mosquito-related products). FDA states that it is providing the Guidance to clarify circumstances under which such products are regulated by FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) and other circumstances under which such products are regulated by EPA as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Scope of Guidance
FDA notes that the Guidance is important in light of the public health urgency of countering the spread of mosquito-borne disease such as that caused by the Zika virus. While novel mosquito control technologies have gained greater attention, there has been confusion regarding FDA and EPA jurisdiction over such products. FDA, working collaboratively with EPA, is providing the Guidance to clarify the regulatory oversight of mosquito-related products. This includes, but is not limited to, those produced through biotechnology.
The Guidance includes the following examples of new animal drugs regulated by FDA:
- Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans; and
- Products intended to prevent mosquito-borne disease in humans or animals.
Examples of pesticide products regulated by EPA are “[p]roducts intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development).”
Guidance for Sponsors/Manufacturers of Products Intended for use on Mosquitoes
In the Guidance, FDA encourages sponsors of mosquito-related products, other than those that are “intended to prevent, destroy, repel, or mitigate mosquitoes by controlling a mosquito population,” to contact FDA early in the development process. FDA states that if a developer has a jurisdictional question, such as which agency or agencies would have oversight of a mosquito-related product that is expressly intended for both mosquito population control and human disease suppression, the developer may contact either or both agencies via the contacts listed. FDA and EPA will consult with each other on the jurisdictional question, “as is already common practice.” The agencies may suggest a joint meeting among EPA, FDA, and the sponsor to discuss appropriate pathways to market.
The guidance notes that FDA, EPA, and the U.S. Department of Agriculture (USDA) have committed to clarifying how the federal government intends to regulate genetically engineered insects as described in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products. More information on the National Strategy is available in our September 21, 2016, memorandum White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products.
The new FDA guidance states that products intended to prevent mosquito-borne disease in humans or animals are regulated as new animal drugs subject to FDA jurisdiction, but products intended to control mosquito populations would be regulated by EPA as pesticides. That FDA and EPA are attempting to clarify their respective jurisdictions is appreciated. Potential commenters may wish to consider whether the guidance offers sufficient clarity for product development planning purposes. If “products intended to prevent mosquito-borne disease in humans or animals” are under FDA jurisdiction, the status of mosquito repellents currently registered by EPA that make claims about repelling mosquitoes that carry the Zika virus, the West Nile virus, or other viruses is unclear. Additionally, it would seem that the Oxitec mosquito is intended to reduce the mosquito population, among other goals. The Guidance is a good start, but further clarification likely will be needed to support emerging technologies.
More information is available in our memorandum FDA Guidance Addresses FDA and EPA Jurisdiction over Mosquito-Related Products.
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
On February 2, 2016, the Executive Board of the North American Free Trade Agreement (NAFTA) Technical Working Group on Pesticides (TWG) released details of its proposed strategic framework the next five years. The environmental regulatory authorities in the U.S., Canada, and Mexico comprise the TWG and developed the strategy. They are the U.S. Environmental Protection Agency (EPA), Health Canada’s Pest Management Regulatory Agency (PMRA), and Mexico’s Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA) and its Secretaría de Medio Ambiente y Recursos Naturales (SEMARNAT) .
The message from the Executive Board states that the main goal is to “align the North American registration systems for pesticides and products treated with pesticides and make work-sharing a way of doing business.” There are three strategic objectives listed in the message, as described below. Information regarding some of these strategic objectives is discussed in our blog.
Objective 1: Identify trade barriers and approaches to promote equal access and simultaneous introduction for pest management tools, which includes:
- MRL Alignment: This objective includes the alignment of maximum residue limits (MRL) to encourage registrants to consider potential export markets of agricultural commodities intended for treatment with proposed new pesticides or new uses as a way to reduce the number of use expansion submissions and reduce potential trade barriers.
- Expansion, Development and Harmonization of Crop Groups with Specified Representative Crops for Field Crop Residues Studies: The TWG plans to continue ongoing work, through the International Crop Grouping Consulting Committee (ICGCC) for harmonizing crops, on the process for developing new/additional crop groups and to revise the existing guidance document as new scientific information becomes available.
Objective 2: Encourage cooperation on joint reviews of new pesticides and uses, and the reevaluation/re-registration review of pesticides to increase efficiency and quality of decision making, which includes:
- Increasing Simultaneous Registration of Biopesticides: The TWG will seek opportunities with biopesticide manufacturers for their simultaneous submission of registration applications to NAFTA countries to provide opportunities for joint review.
- Minor Use Joint Reviews: The TWG will continue the focus on pesticide registration for minor uses, and will work with the minor crop grower communities, the U.S. IR-4 program, and the Canadian Pest Management Centre program to: identify pest control gaps; follow the established minor use joint review procedures to enable joint submissions of registration applications in U.S. and Canada; and make simultaneous regulatory decisions in both countries within a 10-month timeframe.
- Coordination of Registration Review and Re-evaluation: The TWG will continue to identify opportunities for countries to work-share on pesticides; work shares that are currently ongoing include the glyphosate and neonicotinoid pesticides.
Objective 3: Work cooperatively on priority science and regulatory issues and practices including data requirements, science approaches and policies for data interpretation, and risk assessment and communications of regulatory decisions, which includes:
- Pollinator Protection: The TWG will share information on policies, risk assessments, initiatives, and actions to improve the countries’ protection of pollinators, and EPA and PMRA will provide training to SAGARPA and SEMARNAT on the process for conducting pollinator risk assessments.
- Alignment of Data Requirements/Science Policies: The TWG will facilitate a common approach and efficiencies in joint reviews and worksharing among the EPA, PMRA, and Mexico; all countries will continue to consider the alignment of data requirements and science policies. This will include developing and completing guidance for the review and interpretation of specific data and guidance related to risk assessment methodologies (e.g., cumulative exposure) and novel technologies such as RNAi (Ribonucleic acid Interference).
- Integrated Approaches to Testing and Assessment (IATA): EPA and PMRA will continue to work on initiatives related to Chemical Testing in the 21st Century, e.g., a bilateral effort by EPA and PMRA to develop an OECD Guidance Document that builds upon the existing EPA and PMRA guidelines on waiving/bridging acute toxicity studies, and a continuation of their joint efforts to work with stakeholders on alternative approaches for the acute toxicity studies.
The objectives and specific focus areas are ambitious. To achieve some of these objectives will require addressing some controversial issues, for example, the confidential treatment of data that underlie these programs (e.g., MRLs, residue studies, biopesticide registrations).
More information on the strategy is available on Health Canada’s website.
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.
By Lisa M. Campbell and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has launched a new pesticides website: http://www2.epa.gov/pesticides, and a new biopesticides website: http://www2.epa.gov/pesticides/biopesticides, among others. EPA states that this gradual move to new versions of its content is part of a larger EPA effort to build a more user-friendly website.
The updated biopesticides website focuses on providing general information on biopesticides, as well as tools to assist applicants for registration, and is organized into the following areas:
- What are biopesticides?;
- Biopesticide registration information;
- Plant incorporated protectants (PIPs); and
- Where can I find more information on biopesticides?
With this transition, web page addresses will be different which may cause links and bookmarks to break. EPA states that it is working to fix any broken links. The majority of the old pesticide pages will redirect to the new web areas, but bookmarks will still need to be updated. EPA’s new “Page Not Found” notification will help website users find what they are looking for by providing suggested search terms, links to the A-Z index, and other helpful links. The search feature available on every EPA web page and in the archive (archive.epa.gov) can also be useful in finding content.
Other updated pesticide related links are:
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:
- 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
- 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.