By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson
On November 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of, and requested comments on, the updated Draft Guidance for Plant Regulator Products and Claims, Including Plant Biostimulants (Draft Guidance). The original Draft Guidance (2019 Draft Guidance) was made available on March 27, 2019. EPA states that the updated Draft Guidance “incorporates diverse and helpful changes made in response to stakeholder feedback” received during the initial comment period in 2019 and “clarifies which biostimulants, biological substances, and mixtures, in addition to the associated product label claims, EPA considers plant regulators.”
EPA is now seeking comments on those changes. Comments on the updated Draft Guidance are due on or before December 30, 2020, in docket EPA-HQ-OPP-2018-0258. 85 Fed. Reg. 76562. EPA states that it anticipates issuing the Draft Guidance in final form in January 2021.
Updates to the Draft Guidance
EPA made several changes to the Draft Guidance. Of note, the Disclaimer section of the Draft Guidance EPA now states that the “contents of this document do not have the force and effect of law and are not meant to bind the public in any way.” It states further that the “document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.”
Additional changes of interest to the updated Draft Guidance include:
- Revised Definitions of “Plant Biostimulant”: In the 2019 Draft Guidance, EPA sought comments on whether it should develop, through rulemaking procedures, a definition for plant biostimulant. EPA states that subsequent to the release of the 2019 Draft Guidance, the U.S. Department of Agriculture (USDA) issued a Report to Congress on Plant Biostimulants that included two new definitions of plant biostimulants. As a result, EPA states that it does not plan to develop a separate definition of plant biostimulants. In the Draft Guidance, EPA deleted the Proposed European Commission definition of plant biostimulant and added two of USDA’s new definitions of plant biostimulants:
- 2019 USDA Report Alternative Definition 1: A plant biostimulant is a naturally-occurring substance, its synthetically derived equivalent, or a microbe that is used for the purpose of stimulating natural processes in plants or in the soil in order to, among other things: improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve characteristics of the soil as a medium for plant growth. The characteristics may be physical, chemical, and/or biological. The plant biostimulant may be used either by itself or in combination with other substances or microbes for this purpose.
- 2019 USDA Report Alternative Definition 2: A plant biostimulant is a substance(s), microorganism(s), or mixtures thereof, that, when applied to seeds, plants, the rhizosphere, soil or other growth media, act to support a plant’s natural nutrition processes independently of the biostimulant’s nutrient content. The plant biostimulant thereby improves nutrient availability, uptake or use efficiency, tolerance to abiotic stress, and consequent growth, development, quality or yield.
- Clarification of Focus on Pesticide Claims and Composition: In the section “Pesticide Products Required to be Registered,” EPA has added the following paragraph:
The Agency historically has had a claims-based approach to pesticide regulation, but emphasizes that the term “claims-based” does not mean “claims-only based.” As the Agency has explained, “…the term “pesticide product” will be used to describe a particular pesticide in the form in which it is (or will be) registered and marketed, including the product’s composition, packaging and labeling.” (49 FR 37917, September 26, 1984.) The Agency has always considered the composition of a product, as well as its associated claims, when making a regulatory determination, which is reflected in 40 CFR 152.15.
In the “Claims Examples” section, EPA further adds the following sentences:
When claims for increased or decreased growth, yield, germination, maturation, etc. are consequent to intended uses of products or substances as plant nutrients (fertilizers), plant inoculants, soil amendments, and/or as other non-pesticidal uses, such products and substances may be excluded from regulation under FIFRA in the absence of any plant regulator claims. The example claims listed in Tables 1a through 1c are specifically tied to the exclusions from the FIFRA definition of a plant regulator and are worded as such. When such claims for accelerating or retarding the rate of growth, or maturation, the behavior of plants, or the produce thereof are made without qualification or reference to a specific exclusion, such claims are and will continue to be considered plant regulator claims.
- Revisions to Claim Examples: EPA has modified the examples of plant nutrition, plant inoculant, soil amendment, generic non-pesticidal, and pesticidal claims as set forth in Tables 1a, 1b, 1c, 2, and 3. Some of the changes move a claim from one chart to another. EPA has added that certain claims can improve foliar and seed nutrient conditions. Perhaps most importantly, EPA has added a footnote to each chart that the stated examples “are not comprehensive and other claims may include other synonymous terms and phrases.”
- Discussion of Plant Regulator Active Ingredients: EPA has deleted what was Table 4 in the 2019 Draft Guidance, which provided a list of active ingredients contained in EPA registered products having modes of action that trigger regulation under FIFRA as a pesticide. Instead, EPA has added three new sections:
- Substances that have no other use than as plant regulators or pesticides: EPA has identified certain substances that “are generally recognized to have no other significant commercially valuable use, either alone or in combination with other substances, other than use as plant regulators (i.e., as pesticides).” These include corn glutens; L-glutamic acid (LGA) and gamma-aminobutyric acid (GABA); homobrassinolide and other brassinosteroids; lysophosphatidylethanolamine (LPE); 1-Octanol; and sodium o-nitrophenolate, sodium p-nitrophenolate, and sodium guaiacolate.
- Substances that may have plant regulator and non-plant regulator activity: EPA has identified “substances with additional modes of action, not considered to be plant regulator modes of action that may include, but are not limited to: the alleviation of abiotic stressors (e.g., temperature and water stress); increased water and nutrient use efficiency and/or uptake; increased availability of inorganic nutrients in the soil to plant roots and seeds; increased absorption of inorganic nutrients applied to plant foliage; and changes to the biotic and abiotic characteristics of soils making them a better medium for plant growth.” Those described by EPA include complex polymeric polyhydroxy acids (CPPAs) and humic acids (HAs); and seaweed extracts (SWE).
- Regulatory approaches for substances and products that have multiple plant regulator and non-plant regulator modes of action: The Draft Guidance now states the following:
The Agency recognizes that CPPA, humic acids, seaweed extracts and other PBS products may possess multiple modes of action that are occurring simultaneously when applied to plant foliage, roots, seeds, other propagules, and to the soil. The Agency also recognizes that not all uses of PBS may be intended for plant regulator or other pest control purposes. If it can be demonstrated that a particular product has the activity claimed on the product label (and any other informational media) and does not make any plant regulator or pest control claims on the product label (and any other informational media) it may be excluded from FIFRA regulation. Pursuant to 40 CFR 152.15(b), the Agency will consider whether a substance “has no significant commercially valuable use” other than as a pesticide, when considering whether the substance (or product) is a pesticide. If it can be demonstrated that the substances contained in such products may have significant commercially valuable uses other than as plant regulators (i.e., pesticides), they may be excluded from regulation under FIFRA in the absence of any plant regulator claims (see examples in Table 3) and in the absence of any other pesticidal claims (e.g., anti-plant pathogen claims). Review of such “multiple use” products may be conducted by the Agency under PRIA Code M009.
For example, if a product containing seaweed extracts or humic acids is intended for use in alleviating abiotic stress (e.g., extreme temperature, drought/salt stress) on plants, or for stimulating increased nutrient assimilation from the soil, is labeled using product claim examples (Tables 1a-c and 2), and can provide product performance data supporting such product claims, the product may be excluded from regulation under FIFRA.
The removal of Table 4 from the Draft Guidance appears to address comments submitted on the 2019 Draft Guidance that criticized EPA for developing a list of active ingredients that would trigger pesticide registration requirements when several of those substances possessed non-pesticidal modes of action. Interestingly, many of the significant proposed changes address issues related to composition and to substances and products with plant regulator and non-plant regulator modes of action, rather than claims. Also of note is EPA’s current intent not to initiate a rulemaking to define plant biostimulant, but instead to rely upon definitions developed by USDA and under review by Congress.
There are a significant number of issues of interest, and those with potentially affected products should review the updated guidance closely.
By Lisa M. Campbell, Timothy D. Backstrom and Barbara A. Christianson
On May 1, 2020, the U.S. Environmental Protection Agency granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations that serve as a vector for a variety of diseases including Zika virus. The EUP is designed to test the effectiveness of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in specific locations with monitoring and sampling of the resultant mosquito populations. These field tests will proceed only after state and local approval, and they are intended as a first step toward potential wider use of genetically modified mosquitoes in the U.S.
Oxitec’s field tests will be conducted, if approved by state and local authorities, over a two-year period in Monroe County, Florida, beginning in summer 2020, and in Harris County, Texas, beginning in 2021. During these field tests, Oxitec will release into the environment male mosquitoes that have been genetically modified to carry a protein that will inhibit the survival of female offspring. After males carrying this protein mate with wild female mosquitoes, it is anticipated that only the male offspring will survive to become fully functional adults and that these male offspring will retain the same genetic modification. This should provide multi-generational effectiveness in reducing the number of adult females in Aedes aegypti mosquito populations in the release areas.
Female mosquitoes are the ones who bite humans and that serve as the vector for blood-borne illnesses. Since only male mosquitoes will be released into the environment and their female offspring are not expected to survive, EPA does not believe they will pose a health risk to the human population. EPA anticipates that these modified mosquitoes could be an effective tool in combatting the spread of certain diseases like the Zika virus in light of the growing resistance of mosquito populations to current insecticides. It is also anticipated that there will be no adverse effects to animals such as bats and fish who consume the genetically modified mosquitoes.
Oxitec is required to monitor and sample the mosquito population weekly in the treatment areas to determine how well the product works for mosquito control and to confirm that the modified genetic traits disappear from the male Aedes aegypti mosquito population over time. EPA has also maintained the right to cancel the EUP at any point during the 24-month period if unforeseen outcomes occur.
EPA’s decision and the approved permit are available here.
Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.
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 Lisa M. Campbell and Lisa R. Burchi
On May 15, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is extending the comment period for the Draft Guidance for Plant Regulator Label Claim, Including Plant Biostimulants that was made available on March 27, 2019. 94 Fed. Reg. 21773. The original comment date was May 28, 2019; comments are now due by July 28, 2019, in Docket No. EPA-HQ-OPP-2018-0258. Several trade groups and a number of individual companies had requested an extension due to the complexity and breadth of the guidance. EPA’s grant of additional time is likely very welcome to many stakeholders, given the significant issues that this guidance addresses and given the work that many stakeholders have done on the issues it addresses.
EPA states that the draft guidance is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and thereby distinguish claims that would not subject plant biostimulants to regulation under FIFRA as plant regulators.
More information on the guidance is available in our April 2, 2019, memorandum “EPA Releases Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Plant Biostimulants.”
By Lisa M. Campbell, Sheryl Lindros Dolan, and Margaret R. Graham, M.S.
On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted 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. Comments on the draft guidance are due by May 28, 2019.
EPA states that the draft guidance is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and thereby distinguish claims that would not subject plant biostimulants (PBS) to regulation under FIFRA as plant regulators. While EPA has not yet promulgated a regulatory definition for a PBS, the draft guidance describes a PBS as “a naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.” EPA is seeking comment on the draft guidance itself, as well as on whether it should develop a definition for PBSs. EPA states that there is currently no statutory definition for PBSs under FIFRA and that development of a definition for PBSs would require rulemaking. The guidance also notes that the 2018 Farm Bill, enacted on December 20, 2018, does provide a statutory definition for PBSs, which is: “a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield.”
In developing the draft guidance, EPA states that it “considered whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators under FIFRA thereby triggering regulation as a pesticide” and that “a key consideration is what claims are being made on product labels.” Further, as FIFRA Section 2(v) both defines plant regulator and explains which substances are excluded from the definition, “many PBS products and substances may be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products.”
The draft guidance provides several examples of both product label claims that are considered plant regulator claims and claims that that are not considered plant regulator claims. The examples are described in the Tables below.
- “Product label claims generally considered ‘non-pesticidal’ (i.e. non-plant regulator claims),” including: “plant nutrition-based claims” (Table 1a); “plant inoculant-based claims” (Table 1b); and “soil amendment-based claims” (Table 1c):
- “Generic product label claims for products not covered by the exclusions in the FIFRA Section 2(v) definition of a plant regulator,” including “examples of generic product label claims generally considered by the Agency to be ‘non-pesticidal’” (Table 2):
- “Plant regulator product label claims that are consistent with the FIFRA Section 2(v) plant regulator definition” including “examples of label claims that are considered … to be plant growth regulator claims that trigger regulation under FIFRA as a pesticide” (Table 3):
- “EPA-registered, naturally-occurring, plant regulator active ingredients having modes of action and associated product label claims that are consistent with the FIFRA definition of a plant regulator” (Table 4):
By Lisa M. Campbell and Lisa R. Burchi
On November 21, 2018, in Court of Justice of the European Union (EU), the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an active substance, specifically the complete list of all tests submitted by the operators seeking the inclusion of glyphosate in Annex I to Directive 91/414.
The judgment provides a detailed history of the case, beginning in 2010, when Applicants requested access to the documents in question. In this initial case, the Secretary General of the Commission agreed with the Federal Republic of Germany’s decision to refuse access to the documents (contested decision) on the basis that disclosure in Article 4(2) of Regulation No. 1049/2001 would undermine protection of the commercial interests of a natural or legal person. In upholding Germany’s decision, the Secretary General found that there was “no evidence of an overriding public interest in disclosure” within the meaning of Article 4(2) of Regulation No. 1049/2001, and also that the information “did not relate to emissions into the environment” within the meaning of Article 6(1) of Regulation No. 1367/2006 concerning public disclosure of information on the environmental effects of glyphosate. As such, “protection of the interests of the manufacturers of that substance had to prevail.”
The Applicants brought an action for annulment of the contested decision to the Registry of the General Court. After one of the documents at issue (a draft assessment report issued by Germany prior to the initial inclusion of glyphosate in Annex I to Directive 91/414) was produced to the court (but still not released to the Applicants), the General Court ruled to annul the contested decision. The Commission appealed this annulment, stating that the General Court erred in its interpretation of the term “information [which] relates to emissions into the environment.” The Court of Justice was persuaded by this argument, set aside the initial judgment, and referred the case back to the General Court. The case was then assigned to the Fourth Chamber. The dispute was limited to the part of the document at issue that “contains information on the degree of purity of the active substance, the ‘identity’ and quantities of all the impurities present in the technical material, the analytical profile of the batches, and the exact composition of the product developed.”
The Applicants put forward three pleas in law in support of their action. The pleas, and the basis for the General Court/Fourth Chamber’s rejections of those pleas, are as follows:
- Failure to Take Account of the Scope of Article 4(5) of Regulation No. 1049/2001: Article 4(5) of Regulation No. 1049/2001 provides that a Member State may request an institution not to disclose a document originating from that State without its prior agreement. Applicants submitted that Article 4(5) of Regulation No. 1049/2001 does not constitute a right of veto for a Member State and that the Commission may not rely on the Member State’s opinion regarding the application of an exception provided for by Article 4(2) of that Regulation. The General Court/Fourth Chamber stated that “the argument put forward cannot succeed, since Article 4(5) of Regulation No 1049/2001 is not the basis on which the Commission refused access to that document. Consequently, the first plea in law must be rejected.” Instead, Article 4(2) was the basis for Germany’s decision, and the Commission verified that Germany’s reasons for that decision were “prima facie, well founded.”
- Overriding Public Interest In Disclosing Information Relating to Emissions Into the Environment: Applicants maintained that the exception to the right of access designed to protect the commercial interests of a natural or legal person must be waived, because of an overriding public interest in disclosure of the information requested, which relates to emissions into the environment. Specifically, Applicants argued that information related to the identity and quantity of impurities present in glyphosate and related test information must be disclosed so that it could be determined “which toxic elements are emitted into the environment and are liable to remain there for some time.” With regard to the concept of “information relating to emissions into the environment,” the General Court/Fourth Chamber rejected arguments that the provision must be interpreted restrictively to mean only direct or indirect release of substances from installations. The General Court/Fourth Chamber also found, however, that the concept cannot be interpreted in a way that would “deprive of any practical effect the possibility” that a Member State could refuse to disclose environmental information or “jeopardise the balance which the EU legislature intended to maintain between the objective of transparency and the protection of [commercial] interests.” In rejecting the second plea, the General Court/Fourth Chamber states:
Since the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance, it must be held that the information in the document at issue does not relate to emissions whose release into the environment is foreseeable and has, at the very most, a link to emissions into the environment. Accordingly, such information is excluded from the concept of “information relating to emissions into the environment,” in accordance with paragraph 78 of the judgement on appeal.
- Alleged Infringement of Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention: Applicants argued that the contested decision is not in accordance with Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention, on the ground that the Commission did not evaluate the actual risk of damage to the commercial interests invoked. The General Court/Fourth Chamber stated that it must be held “that the Commission correctly weighed up the relevant interests, having set out precisely and specifically the way in which the commercial interests of producers of glyphosate or plant protection products containing it would be jeopardised by the disclosure of the document at issue.”
After rejecting all three pleas, the General Court/Fourth Chamber held that the action must be dismissed in its entirety, and ordered Applicants to pay the costs relating to the various proceedings.
This case has been monitored closely because of the potential implications for companies that have submitted data or other information claimed as confidential that could be disclosed based on “overriding public interest.” The American Chemistry Council (ACC), CropLife America, CropLife International (CLI), the European Chemical Industry Council (Cefic), the European Crop Care Association (ECCA), the Association européenne pour la protection des cultures (ECPA) and the National Association of Manufacturers (NAM) all intervened in support of the form of the order sought by the Commission. The decision, and, in particular, the limitations placed on the scope of what is to be considered “information on emissions into the environment” provides helpful guidance and ensures that the exceptions provided for disclosure do not swallow the general rules under which institutions must refuse access to documents.
More information on glyphosate issues is available on our blog.
By Margaret R. Graham
On October 10, 2018, EPA’s Office of Pesticide Programs (OPP) announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and that on November 1, 2018, from 8:30 a.m. to 12:00 p.m., it will be hosting an informational seminar on biotechnology-pesticide issues for stakeholders. 83 Fed. Reg. 50921. The PPDC meeting and informational seminar will be held at 1 Potomac Yard South, 2777 S. Crystal Dr., Arlington, Virginia, in the lobby-level Conference Center. EPA’s draft agenda for the PPDC meeting has been posted to the PPDC website.
The PPDC meeting agenda lists the following seven sessions:
- Pesticide Registration Improvement Act (PRIA) -- session goal is to “provide the PPDC with an update on EPA’s progress in implementing PRIA”;
- Smart Label Project/e-CSF -- session goal is to “provide the PPDC with an overview the electronic pesticide label, the benefits to EPA and stakeholders, and next steps”;
- Emerging Application Technologies -- session goal is “to inform the PPDC about how new unmanned aerial vehicle (UAV) technology is working in the field for pesticide applications and how this new technology may benefit the agricultural sector”;
- Benefits of Biological Products: Industry Perspective -- session goal is to explain “BPPD’s focus on low risk products and biopesticides, how EPA encourages low risk products by having a different division and registration timelines and costs” and “how pesticides, whether conventional or biological, are reviewed with rigor and held to the same safety standard”;
- Integrated Mosquito Management Training -- session goal is to “provide awareness of on-line training and manual (in English and Spanish) focusing on Integrated Mosquito Management created by AMCA with funding by the Centers for Disease Control and Prevention”;
- Public Health Workgroup -- session goal is to “report on the progress of the group’s Emergency Preparedness Plan and solicit feedback”; and
- 21st Century Toxicology: OPP’s Efforts on Non-Animal Alternative Testing for the Acute 6-Pack -- session goal is to “update the PPDC on OPP’s recent progress toward the reduction of animal use in testing, and the implementation of alternative methods.”
Nancy Beck, Ph.D., Deputy Assistant Administrator of the Office of Chemical Safety and Pollution Prevention and Richard Keigwin, OPP Director, will make the opening remarks. After the sessions, EPA is providing a 15-minute window for public comments. PPDC meetings are free, open to the public, and no advance registration is required.
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.