By Lisa M. Campbell and Lara A. Hall, MS, RQAP-GLP
By Lisa M. Campbell and James V. Aidala
On April 30, 2018, the U.S. Environmental Protection Agency (EPA) will publish in the Federal Register a proposed rule entitled "Strengthening Transparency in Regulatory Science" (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.” EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.” EPA further states that “EPA is proposing to establish a clear policy for the transparency of the scientific information used for significant regulations: specifically, the dose response data and models that underlie what we are calling ‘pivotal regulatory science.’ ‘Pivotal regulatory science’ is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.”
EPA intends the rule to provide this transparency “in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.” EPA “will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.” EPA states that its “regulatory science” should be “consistent with the Office Management and Budget’s Final Information Quality Bulletin for Peer Review,” and that “[r]obust peer review plays a critical role in independently validating key findings and ensuring that the quality of published information meets the standards of the scientific and technical community.” In addition, EPA states, the proposed rule “is designed to increase transparency of the assumptions underlying dose response models,” noting that “[t]he use of default models, without consideration of alternatives or model uncertainty, can obscure the scientific justification for EPA actions.”
EPA states: “Across EPA programs much of the science that informs regulatory actions is developed outside the Agency. It is the charge of regulators to ensure that key findings are valid and credible, as required by OMB’s Guidelines.” EPA “believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government,” and “[n]othing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections.”
The rule as proposed has ten subparts:
- Section 30.1 states the purpose of the rule: “This subpart directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation.”
- Section 30.2 sets forth definitions of the following five terms: “dose response data and models”; “pivotal regulatory science”; “regulatory decisions”; “regulatory science”; and “research data.”
- Section 30.3 addresses what and what is not subject to the rule.
- Section 30.4 provides: “EPA shall clearly identify all studies (or other regulatory science) relied upon when it takes any final agency action. EPA should make all such studies available to the public to the extent practicable.”
- Sections 30.5 and 30.6 establish requirements applicable to EPA’s use of dose response data and models underlying pivotal regulatory science, as those terms are defined elsewhere in the proposed rule.
- Section 30.7 requires EPA to conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, as those terms are defined, and to ask peer reviewers to “articulate the strengths and weaknesses of EPA’s justification for the assumptions applied and the implications of those assumptions for the results.”
- Section 30.8 addresses how EPA is to account for cost under the rule.
- Section 30.9 provides that EPA may grant an exemption to the rule on a case-by-case basis if EPA “determines that compliance is impracticable” because either: it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science is publicly available in a manner sufficient for independent validation, in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security; or it is not feasible to conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions for reasons outlined in OMB Final Information Quality Bulletin for Peer Review Section IX.
- Section 30.10 addresses other requirements applicable under the rule.
EPA is soliciting comments on the proposed rule and “how it can best be promulgated and implemented in light of existing law and prior Federal policies that already require increasing public access to data and influential scientific information used to inform federal regulation.” Among the issues EPA asks for comment are the following:
- All aspects of the proposed regulation and the bases articulated for it.
- Whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the Agency may take to further the policies articulated.
- Effects of the proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted or if other requirements would affect implementation.
- Which criteria the Agency should use to base ay exceptions, including whether case-by-case exceptions may be appropriate.
- Whether and to what extent the rule requirements, or other provisions and policies, should apply to other stages of the rulemaking process, including proposed rules, as well as to other types of Agency actions and promulgations, such as guidance.
- Whether a narrower scope of coverage would be appropriate, such as only final regulations that are determined to be “major” under the Congressional Review Act, or “economically significant “under EO 12866.
- Whether certain categories of regulations should be excluded from coverage, such as those that merely reaffirm an existing standard, or some other category, including whether the rule should apply to individual party adjudications, enforcement activities, or permit proceedings when EPA determines that these provisions are practical and appropriate and that the actions are scientifically or technical novel or likely to have precedent-setting influence on future actions, and whether the Agency should apply the provisions of the proposed rule to these actions or to specific types of actions within these categories.
- Whether other agency actions, beyond significant final regulatory actions under EO 12866, should be included, such as site-specific permitting actions or non-binding regulatory determinations.
- The definitions of “pivotal regulatory science,” and “dose response data and models” and how to implement such definitions.
- How to incorporate stronger data and model access requirements into the terms and conditions of cooperative agreements and grants.
- How EPA can build up on other federal agencies’ policies regarding grantee and cooperator requirements for data access and data sharing.
- Methodologies and technologies designed to provide protected access to identifiable and sensitive data, such as individual health data, and on commenters’ experience with the use of such methodologies and technologies and their strengths and limitations.
- How to balance appropriate protection for copyrighted or confidential business information, including where protected by law, with requirements for increased transparency of pivotal regulatory science.
- Whether there are other compelling interests besides privacy, confidentiality, national and homeland security that may require special consideration when data are being released.
- Implementation of the proposed regulation, including which parts of the Agency should be responsible for carrying out these requirements.
- The effective date of the rule and whether there should be a phase-in, as well as the manner in which the rule should apply to previous records.
- Whether and how the proposed rule should apply to dose response data and models underlying pivotal regulatory science if those data and models were developed prior to the effective date.
- How the prospective or retrospective application of the provisions for dose response data and models or pivotal regulatory science could inadvertently introduce bias regarding the timeliness and quality of the scientific information available.
- How to address a circumstance in which EPA has a statutory requirement to make a determination for which scientific information publicly available in a manner sufficient for independent validation does not exist
- Additional implementation challenges not discussed in the notice.
- Whether proposed exemptions are appropriate.
- Whether disclosure requirements applicable to dose response data and models in the proposed rule should be expanded to cover other types of data and information, such as economic and environmental impact data and models that are designed to predict the costs, benefits, market impacts and/or environmental effects of specific regulatory interventions on complex economic or environmental systems.
On April 26, 2018, EPA Administrator Scott Pruitt was a witness in a hearing before the U.S. House Committee on Energy and Commerce, Subcommittee on Environment entitled The Fiscal Year (FY) 2019 U.S. Environmental Protection Agency (EPA) Budget. Administrator Pruitt discussed the forthcoming proposed rule at this hearing, stating that the rule is an effort to make the data and methodology that underlie scientific studies, oftentimes done by third parties, more accessible and more transparent -- especially to those interested stakeholders commenting on the determinations that the studies support. Many of the Committee members were supportive of the Science Rule, stating that the transparency is long overdue. Others expressed concerns with the proposed rule, including concerns about a potential for EPA to handpick certain “public” studies and to discount other valid studies only because they did not divulge all of their confidential data; and concerns regarding the inability to protect important confidential information, such as identities of patients.
The proposed rule is controversial and will likely be the subject of significant comment. Similar to when legislative proposals offer new terminology, the establishment and use of terms such as “pivotal regulatory science” suggest some distinction between it and “not so pivotal science” not subject to the new procedures and requirements. How such distinctions will be made and what the impact may be could be significant for companies that submit “routine” data under existing Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulations concerning registration data requirements. Interest in the subject has been reported to focus especially on questions some have raised about the way EPA has utilized studies and scientific data to support initiatives and rules issued by the air program. What that raises is a fear that addressing some concerns about how air regulations are justified might have unintended consequences in other EPA media programs.
In brief, for pesticide registrants, the rule poses significant potential issues. For example, registrants spending millions of dollars on studies necessary to register products that are proprietary and protected from release to those who might use them to register their own products without compensating the owners; issues with regard to EPA’s reliance under the proposed rule on these registrant generated and FIFRA required studies will need to be carefully considered carefully. As another example, EPA’s review of epidemiology data underlying its conclusions regarding chlorpyrifos and other organophosphate pesticide requirements potentially may be subject to more stringent requirements than they previously were. Registrants should review the proposed rule carefully and monitor closely developments relating to it.
By Lisa M. Campbell and Heather F. Collins, M.S.
On March 22, 2018, the U.S. Environmental Protection Agency (EPA) released the Pesticide Registration Notice (PR Notice) 2018-1 issued by the Office of Pesticide Programs (OPP) entitled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(ll)” (PR Notice 2018-1). Notice of Availability issued on March 21, 2018. 83 Fed. Reg. 12385. The PR Notice states that it “describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.” It “revises the method and criteria used by EPA for evaluating ‘sufficient economic incentive’ under FIFRA section 2(ll)(2),’” and it “also clarifies that minor use under FIFRA section 2(ll)(1) is based on acreage reported in the [U.S. Department of Agriculture (USDA)] Census of Agriculture.”
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)(1) defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States. Section 2(ll)(2) of FIFRA defines a minor use of a pesticide as one that lacks sufficient economic incentive to seek or maintain a registration but has private or social value.
PR Notice 2018-1:
- Clarifies that the USDA’s most recent Census of Agriculture, conducted every five years by the USDA’s National Agricultural Statistics Service (NASS), is the appropriate source for data on acreage or crops grown in the U.S. to establish a minor use under the acreage definition in FIFRA 2(ll)(1);
- Revises and provides guidance to registrants concerning the method used by EPA for evaluating “sufficient economic incentive” under FIFRA Section 2(ll)(2); and
- Explains how qualitative information may be used to inform the quantitative analysis and interpret the results.
Previously, EPA’s interpretation of economic minor use in Section 2(ll)(2) was based on PR Notice 97-2. EPA states PR Notice 2018-1 supersedes PR Notice 97-2. EPA states that through PR Notice 2018-1, EPA “seeks to identify and encourage the registration of pesticides for minor uses to protect communities from harmful pests.” EPA states in PR Notice 2018-1 that “the existing methods for identifying an economic minor use in PRN 97-2 do not consider all relevant factors which could affect the incentives of a registrant to apply to register a minor use,” and that “use of the approach in PRN 97-2 to identify economic minor uses could prevent applicants from registering pesticides that would be beneficial to users and growers, thus limiting the availability of pesticides for certain use sites.” For this reason, “EPA revised the method to determine an economic minor use.”
PR Notice 2018-1 is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use. The criteria in PR Notice 97-2 only applied to conventional pesticides.
EPA states the rationale for revising the PR Notice to consist of the following:
- EPA has decided to revise the policy on determining minor use.
- First, PRN 97-2 is outdated regarding the crops that would not meet the acreage definition of a minor use under FIFRA section 2(ll)(1). PRN 97-2 contained a fixed list of crops that were grown on more than 300,000 acres in 1997, but cropping patterns change over time and the list of crops provided in PRN 97-2 is no longer accurate.
- Second, the method in PRN 97-2 does not accurately reflect economic incentive to register pesticides. Gross revenue is not an appropriate measure for estimating returns on an investment; since it does not account for production and distribution costs, it overstates the returns to the investment. However, revenue from a single year understates the time period when a firm would receive a return on an investment. Finally, gross revenue at full market potential does not account for the difference in timing between costs of registration and future returns. Costs are likely to be incurred at the beginning of registration, whereas revenues will occur over multiple, future years.
- Third, PRN 97-2 applies only to registration actions on conventional pesticides. The notice specifically states that it does not apply to registrations of biopesticides and antimicrobials (e.g., disinfectants). The method described in this PRN may be used to evaluate the registration incentive for all types of products registered by each of OPP's registering divisions.
Additionally of note, EPA states in PR Notice 2018-1 that seeking minor use designation is not required as part of the pesticide registration process. It is an optional designation that an applicant can seek to obtain certain incentives associated with minor uses, such as:
- Extension of exclusive use of data under FIFRA Section 3(c)(1)(F)(ii); and
- Qualifying for an exemption from the fee or waiver of a portion of the registration service fee for an application for minor uses of a pesticide under FIFRA Section 33(b)(7)(D).
More information on other PR Notices is available on our blog under key phrase Pesticide Registration Notice.
By Lisa M. Campbell and Lisa R. Burchi
On March 8, 2018, the U.S. Environmental Protection Agency (EPA) announced its release of final guidance clarifying where first aid statements should appear on the label of pesticide products. EPA also posted a response to public comments. Links to the final guidance and to the response to public comments documents are below:
EPA states that it was prompted to develop this guidance when it learned “that there was a discrepancy in how the ‘location of first aid statement,’ per [40 C.F.R. Section 156.68(d)] is interpreted by EPA and those in the pesticide registrant community.” EPA notes that its review and approval of pesticide labeling is generally of a “master” label and thus does not always include a review of the location or placement of specific language on a label.
On December 7, 2016, EPA posted a memorandum for public comment entitled “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement and Clarification on Definition of Label ‘Panel’ per 40 CFR 156.68” to clarify the interpretation of the term “panel” in the context of 40 C.F.R. 156.68 and to clarify where first aid statements must appear on pesticide labels, based on their Toxicity Category.
In its final guidance, EPA states it “will continue to require that Toxicity Category I products have the first aid statements on the front panel except in cases where a variation has been approved.” Further, based on comments received and the wide reliance by the regulated community on the interpretation that “any panel” includes inside panels, EPA is changing its position from its 2016 memorandum and now “will not require Toxicity Category II and III products to bear the first aid statements on a visible front, back or side panel.”
EPA also listed three recommendations for registrants to consider when printing their container labels:
- For Toxicity Category I products, EPA strongly recommends that registrants consider placing duplicative first aid language on the very back page of the booklet/accordion/saddle stitch label that is immediately “stuck” to the container in case the booklet/accordion/saddle stitch label is accidentally removed.
- Regardless of whether a registrant chooses to place the first aid statements for Toxicity Categories II and III products on a visible front, back, side or inside panel, EPA recommends that duplicative first aid language appear on the very back page of the booklet/accordion/saddle stitch label that is immediately attached to the container in case the booklet/accordion/saddle stitch label is accidentally removed. EPA states that this recommendation is not intended to suggest other information that registrants typically include on the very back page should be moved elsewhere.
- EPA recommends that the registrant community consider designing new booklets/accordion/saddle stitch labels that are not easily removed from the containers. Per 40 C.F.R. Part 156.10(a)(4), the labels are to be “securely attached” to the immediate container of the pesticide product. EPA believes that in many instances these labels are easily removed which is why, EPA states, it believes many registrants have already chosen to put the duplicative first aid statements on the very last page of the label that is attached to the container.
Registrants should review this guidance carefully, as this issue has been the subject of concern and controversy for a number of registrants.
By Lisa M. Campbell and Susan M. Kirsch
On February 15, 2018, the U.S. Environmental Protection Agency (EPA) added resources to its website regarding the Worker Protection Standard (WPS) and the Application Exclusion Zone (AEZ) requirements of the WPS. As of January 2, 2018, full compliance is required with all of the AEZ-related requirements in the WPS. The new EPA website resources include:
While many welcome EPA’s guidance on the many thorny issues presented by the WPS and AEZ requirements, some believe that in places, the newly issued guidance raises additional questions and leaves some significant questions unaddressed. Given the controversy over this rule, this new guidance should be reviewed closely.
More information on the WPS, including EPA’s December 2017 announcement of its intention to revise the AEZ and other WPS provisions, and current implementation deadlines can be found on our blog under key word WPS and key phrase Worker Protection Standard.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On February 1, 2018, the U.S. Environmental Protection Agency (EPA) announced it is publishing new guidance that sets forth a tiered approach intended to help manufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced.
In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Divison (HED) has received “multiple waiver requests for seed-treatment field-trial residue data and has reviewed multiple field-trial datasets that indicated that there was the potential to reduce the number of field trials required to support the registration of seed-treatment uses.” EPA states that to evaluate this hypothesis, the HED Chemistry Science Advisory Council (ChemSAC), in collaboration with the Health Canada Pest Management Regulatory Agency (PMRA), in accordance with the July 11, 2017, Joint Canada/United States Field Trial Requirements “performed a retrospective analysis of all seed-treatment residue data that have been submitted to EPA/PMRA and has developed a tiered approach for determining if current crop-specific field trial data requirements are required to support new seed-treatment uses, or if a reduction in the number of required field trials is appropriate.” EPA’s announcement states that “the analysis showed that the data required to support registration could be substantially reduced and still be protective of human health.”
EPA developed two decision trees detailing the process for determining the residue chemistry field trial data requirements for seed-treatment uses: one for potato seed-piece (PSP) treatments only and another one for all remaining crops. EPA states that this case study demonstrates that application of the guidance set forth in these decision trees can, for both manufacturers and the agency, “potentially save considerable resources in terms of conducting, submitting, and reviewing the studies while still obtaining the data necessary to support seed-treatment pesticide registrations.”
The outlined procedure and memo document will supersede EPA’s previous guidance issued on October 28, 1999, entitled “Classification of Seed Treatments as Food or Nonfood Uses.”
More information is available on EPA’s Determining the Number of Field Trials Required to Register Seed-Treatment Uses webpage.
This announcement of improved review procedures allows EPA to cite both greater coordination across national borders (working with Canada), and reduce unnecessary data requirements. This would fit with the current Administration’s emphasis on reducing regulatory burdens and fostering greater innovation in regulated arenas. It also might be seen as general “good government,” as it updates guidance which is now almost twenty years old. Since seed treatment technology and associated policy issues have both evolved over the years, such a review and revision would seem timely regardless of any larger political directive.
By James V. Aidala
On January 31, 2018, Scott Pruitt, the Administrator of the U.S. Environmental Protection Agency (EPA), announced the establishment of an Interagency Working Group to Coordinate Endangered Species Act (ESA) Consultations for Pesticide Registrations and Registration Review. EPA, the U.S. Fish and Wildlife Service, and the National Marine Fisheries Service (NMFS) (the Services) signed a Memorandum of Agreement (MOA) on the establishment of the working group. The stated purpose of the working group is that it “will provide recommendations to EPA, FWS, and NMFS leadership on improving the [ESA] consultation process for pesticide registration and registration review (‘pesticide consultation process’) and will ensure that the new process is recorded and formalized as appropriate.” The working group’s action plan includes the following:
- Analyze relevant statutes, regulations, and case law. The Working Group will review the statutory requirements under ESA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the case law that has developed on the intersection of ESA and FIFRA; and existing regulations for the pesticide consultation process.
- Review past ESA pesticide consultation practices to learn lessons from recent experience and review current and previous pesticide consultation practices to identify problems and areas for improvement, as well as best practices that should be used in future pesticide consultations.
- Prepare recommendations to improve scientific and policy approaches to ESA pesticide consultations. For example, the Working Group will develop a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation. The Working Group will also help provide clarity as to what constitutes the “best scientific and commercial data available” in the fields of pesticide use and ecological risk assessment, which EPA and the Services are required to use under ESA section 7(a)(2).
- To the extent that current authorities and practices do not allow for the timely and accurate review of pesticides consistent with governing authorities, the Working Group may memorialize its recommendations for a revised regulatory framework, including addressing agency responsibilities, recommended technical approaches, and recommendations for new regulations, a memorandum of understanding, or other appropriate documentation.
Like others before them, the Trump Administration is embarking on a journey to address the problem of how to integrate ESA assessment and consultation requirements with the FIFRA registration process. This directive will help organize a senior level effort to coordinate activities of EPA and the Services and, like past efforts, at the senior management level there will likely be at least a recognition that something needs to be done to fashion a more efficient and predictable process. Currently ESA reviews add months and years to the registration review process and, to date, that process is followed by seemingly inevitable litigation challenging the EPA decision as not sufficient to meet ESA requirements.
The result has been an exhaustive, time and resource intensive initial set of “pilot” biological opinions, and a very long list of promised consultations resulting from past litigation cases. Currently, the workload already committed will be virtually unattainable for a number of years, and as EPA plans to have ESA assessments as part of the registration review process for older pesticides (as well as for future new product applications), the budget and staffing implications are staggering. Meantime, agricultural stakeholders, including pesticide manufacturers and grower groups who use pesticides, fear that the current process might result in the loss or delay in the introduction of needed pest control products.
This is the context for the current attempt to devise an integrated, more efficient process to have any realistic chance to fashion a process which meets the requirements of both statutes. We wish any and all participants good luck and constant senior political level involvement -- they will likely need much of it.
More information on ESA issues is available on our blog.
By Lynn L. Bergeson
Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.
Happy New Year and enjoy reading our predictions!
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 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.