Resources for Varroacide Registration March 8, 2021
Varroa mites (Varroa destructor) are a major problem facing managed honey bee (Apis spp.) colonies and there is a critical need for more varied and effective varroa control tools that can be used in an integrated pest management approach. Registering products intended to kill varroa (i.e., varroacides) is a complicated and expensive process that has legally mandated data requirements. The following outlines resources with more information on this process.
Information on Varroacide Registration:
Beekeepers continue to face ongoing impacts on their colonies from the parasitic Varroa mite, which was introduced to the United States in the late 1980s. Although Integrated Pest Management (IPM) techniques can be effective in combatting this serious pest of honey bees, many beekeepers still find the need to apply chemical treatments intended to manage Varroa mites (i.e., varroacides). While there are multiple pesticides targeting mites (e.g., miticides) on agricultural crops, control of parasitic mites on an insect is more complicated, for both biological and regulatory reasons. Varroa control measures can target either phoretic (i.e., mites on adult bees) or reproductive (i.e., mites on bee larvae) stages of the Varroa mite, or both, but must minimize adverse effects on bee colony members. These criteria result in few effective treatment options being available for controlling Varroa. Historical reliance on a single product over extended periods of time has resulted in mite resistance to some of these products (e.g., coumaphos, tau-fluvalinate) and their loss of efficacy. Limited options and the recurring use of the same types of products will continue to promote the development of mite resistance to currently registered varroacides; however, efforts are underway to expand the number of treatment options that can be used by beekeepers through an IPM approach to extend the duration of efficacy.
While research and development of new varroacides is critical, it is equally important to appreciate the regulatory process needed to ensure that pesticides are safe and effective. The Environmental Protection Agency (EPA) oversees the registration process for pesticides, such as varroacides. The EPA operates under multiple statutes (e.g., Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA], the Food Quality Protection Act [FQPA], the Food Drug and Cosmetic Act [FDCA], and the Endangered Species Act [ESA]). These statutes require the Agency to assess potential risks of pesticides to ensure no unreasonable adverse effects on the environment and to demonstrate a reasonable certainty of no harm to human health. To do this, the EPA must consider all possible routes of chemical exposure depending on how, when, and where the pesticide is proposed for use. All pesticide products (including varroacides) sold in the U.S. must also be accompanied by a label containing both advisory hazard statements and directions for use.
For EPA to make these legally mandated determinations, extensive data requirements (e.g., product chemistry, human toxicity, environmental fate, ecological effects, and residue chemistry) involving both short- and long-term studies are necessary, even if an active ingredient (i.e., the ingredient which will prevent, destroy, repel, or mitigate the pest) has already been registered for other uses in agriculture. This is because active ingredients may have varying modes of action that can result in adverse effects beyond the target pest, and in-hive uses have some unique and challenging considerations in terms of assessing exposure. Data requirements for brand new active ingredients are often costly, with an average cost of $4.65 million for registration of a new biopesticide and $8.97 million for new conventional (chemical) pesticides. In addition to the costs of generating data to fulfill testing requirements, there are registration fees established under the Pesticide Registration Improvement Act (PRIA) and levied by EPA. For chemicals already registered for other uses, data requirements and overall costs may be lower relative to new active ingredients, but these costs are still significant.
Click Here for an overview of the Office of Pesticide Program’s role in processing new varroacide registrations.
Click Here for additional resources located at EPA’s Office of Pesticide Program’s website on the pesticide registration process, types of registrations, pesticide laws, registration fees, permits, waivers, and exemptions, manuals for pesticide registration and label review, submission information, requirements for data labeling, and additional policy and guidance documents.
Identifying a Registrant:
A necessary adjunct to the EPA registration process is the need to identify/secure a registrant. Any domestic entity can become a registrant, and foreign entities may also act as registrants via a U.S. agent. A useful resource for taking the appropriate next steps is EPA’s List of Pesticide Regulatory Consultants, which houses contact information for dozens of potential consultants. While the Code of Federal Regulations (CFR) and the resources identified above provide information on the steps needed to pursue a registration, there are consultants who can assist in the registration process. These consultants typically assist in guiding entities through the regulatory process and in identifying the necessary entities for getting a new product to market. Also, USDA is committed to pollinator protection and is happy to assist entities in identifying resources to support them in their varroacide registration efforts. Inquiries can be sent to Elizabeth Hill at email@example.com.
Relative to miticide uses on agricultural crops, applications of varroacides to bee colonies are considered a minor use that may not allow for registrants to justify the costs to develop varroacides and break-even on such investments, given the small relative market potential. A resource that is available when seeking varroacide registrations is the Inter-Regional Project 4 (IR-4), which helps to facilitate pesticide registrations to protect specialty food uses. In some cases, IR-4 may be able to assist with satisfying some data requirements or in offering other resources when financial incentives are lacking to expand or pursue a new registration. Additional information and contact information for IR-4 is located at their website.
USDA Varroacide Support:
USDA fully supports initiatives to explore the development of new varroacides and new registrations. Although USDA cannot act as the registrant for varroacides, there are other avenues through which USDA may be able to assist researchers and interested parties, such as through:
- Identifying opportunities for public-private partnerships to support research on new products;
- Ensuring public availability of data generated by USDA’s Agricultural Research Service, which may be of use to product developers or potential applicant/registrants in supporting data packages for varroacide registrations; and,
- Providing guidance to new applicants/registrants on the EPA registration process and its underlying data requirements.
For entities that are interested in keeping abreast of new opportunities and/or would like to request USDA’s assistance in navigating the EPA registration process, please email Elizabeth Hill at firstname.lastname@example.org.
Note that USDA historically held the registration for the varroacide oxalic acid but is transitioning the registration to a private entity. Announcements related to this transition will be made via the Federal Laboratory Consortium.
 Under the Federal Insecticide, Fungicide, and Rodenticide Act, a pesticide is defined as any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest https://www.govinfo.gov/content/pkg/USCODE-2013-title7/html/USCODE-2013-title7-chap6-subchapII-sec136.htm.
 These products may be regulated by either the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA), depending upon several factors. Firms with questions about a particular product should contact the agencies to discuss the oversight of their product.
 The term “label” means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers https://www.govinfo.gov/content/pkg/USCODE-2013-title7/html/USCODE-2013-title7-chap6-subchapII-sec136.htm.
 The term registrant means a person who has registered any pesticides pursuant to the provisions of FIFRA.
 The inclusion of any business in this listing does not constitute a recommendation or endorsement by the Federal Government, Environmental Protection Agency, of the U.S. Department of Agriculture. In addition, you will need to contact the entity you are interested in working with to confirm they are still operating as a regulatory consultant.