Biopesticide regulations – USA
Biopesticide products include naturally occurring substances that control pests (biochemical pesticides), microorganisms that control pests (microbial pesticides), and pesticidal substances produced by plants containing added genetic material (plant-incorporated protectants) or PIPs.
What are EPA biopesticide regulations?
Biochemicals can include insect pheromones, natural plant and insect regulators, naturally occurring repellents and attractants and enzymes. Microbial pesticides can include protozoa, algae, fungi, bacteria, and viruses. For plant-incorporated protectants, scientists can introduce a pesticidal protein specific to a pest into the plant’s own genetic material which would allow the plant to manufacture the substance that destroys the pest instead of manufacturing the pest. Biochemicals are further classified into functional classes based on their mode of action which include semiochemicals (pheromones), natural insect growth regulators and natural plant growth regulators.
Biopesticide products require pre-approval from the U.S. EPA (Environmental Protection Agency) before being offered for sale and are evaluated based on their chemistry, toxicology and product performance (if pests are considered public health) using guidelines established under FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act). Although both are considered biopesticides, microbial and biochemical pesticides are subject to separate data requirements. Furthermore, genetically-modified microbial pesticides may be subject to different data requirements depending on use pattern, microorganism, and other factors.
TSG can help
- Prepare and submit federal and state registration applications
- Develop product registration strategy
- Obtain Company Number and Establishment Numbers
- Prepare and submit biochemical classifications and non-FIFRA regulated determinations
- Prepare for and participate in EPA pre-submission meetings
- Prepare and submit pesticide inert petitions
- Place and monitor studies with contract research labs
- Prepare data waivers rationales
- Conduct compliance audits including recordkeeping requirements
- Develop and review labels
- Review product claims for compliance
- Address annual reporting, registration review and renewals
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG's team of scientists and regulatory consultants manage all aspects of product registration, lifecycle management and strategic planning with our customers. Our Washington, DC-based Federal Affairs team is led by Abigail Wacek.
Frequently asked questions
Determining if a product requires registration with EPA is not always an easy process due to the ever-changing regulatory landscape. However, TSG’s regulatory consultants routinely review product claims, use sites and ingredients to determine if the proposed product requires registration as a pesticide with EPA.
If a product falls under EPA’s pesticide registration requirement, TSG can assist your company in developing product registration strategies, preparing and submitting federal and state registrations, and supporting the product post-EPA registration through product life-cycle management. Our regulatory consultants will work with you to identify the data applicable to your registration, then along with TSG’s scientific consultants, provide guidance on addressing each data requirement. TSG frequently assists clients in developing EPA pesticide labels as well as completing the necessary administrative paperwork to support the proposed product application. TSG can submit product applications to EPA on your company’s behalf and will act as your advocate during communications with EPA throughout the registration process, supporting your application from beginning to end.
Plant biostimulants are a growing industry within the naturally-occurring substance arena. Some of the claims commonly found on plant biostimulant labels could be considered as plant growth regulator claims, which would require registration as pesticides under FIFRA. EPA’s draft guidance aims to provide direction as to the claims that trigger EPA pesticide registration as well as known active ingredients that require registration as pesticides with EPA. Although the guidance is currently in draft form and Industry representatives are working with EPA to address concerns, it is important for registrants to be aware of EPA guidance that could potentially impact their existing product line, marketing strategy, budgets and timelines. TSG is following the discussions revolving around the draft guidance closely and can assist registrants with assessing their products in light of the draft guidance. For further information, download our paper on navigating the U.S. regulatory landscape for biostimulants.