Pesticide compliance (FIFRA) - USA
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is the federal statute governing U.S. pesticide regulation. Generally speaking, pesticides are defined as substances or mixtures of substances intended for preventing, destroying, repelling, or mitigating any pest. In order for a pesticide product to be sold or distributed in the U.S., it must be pre-approved and registered with the U.S. Environmental Protection Agency (EPA), each individual state and U.S. territory. TSG helps companies register, renew and maintain the registrations of their products both federally (EPA FIFRA registration) and in the states where the products are to be marketed.
Understanding federal pesticide requirements
EPA separates pesticides into distinct categories and each category has specific data requirements that must be met when applying for federal / FIFRA registration and renewal:
- Antimicrobials – These substances include disinfectants, sanitizers, preservatives, virucides, and fungicides and are used to control the growth of microorganisms such as bacteria, viruses, or fungi.
- Biopesticides – These products are derived from natural materials that have pesticidal applications. There are three classifications: biochemical, microbial, and plant incorporated protectants (PIPs). These products are inherently less toxic, affect only the target pest and are used in very small quantities.
- Conventional pesticides – These pesticides are generally produced synthetically and are used to control various types of pests such as weeds, insects, fungi, and rodents.
- Pesticide device registration - These devices pesticidal activity is due to physical or mechanical actions or due to a substance or mixture of substances.
It should be noted that pesticides that come in contact with food or food contact surfaces require additional approval such as a tolerance or an exemption from tolerance to address residues on surfaces and crops. These tolerance assessments address human exposure.
Addressing state pesticide regulations
Upon EPA approval, pesticides must be registered in each state and territory where they will be distributed or sold and each state has its own laws regarding pesticides. Find out more about state regulations...
TSG can help
We can assist with navigating all areas of federal pesticide regulation in U.S. including:
- Developing a comprehensive product/pesticide registration strategy
- Represent and advocate on behalf of companies with regulators
- Preparing and submitting federal registration and renewals ensuring EPA FIFRA compliance
- Developing product labels
- Preparing and submitting inert petitions
- Placement and monitoring of studies with contract research labs (CRO)
- Preparing data waivers and rationales
- Responding to re-evaluation of pesticide products
- Conducting compliance audits
- In-house training
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.
Thank you for helping us register our products both federally and in so many states – thanks for making the complex straightforward!
Frequently asked questions
According to EPA, Pesticide law defines a “pesticide” (with certain minor exceptions) as:
- Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest
- Any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant
- Any nitrogen stabilizer
The length of time involved in obtaining a federal registration depends on many factors such as the proposed uses of the product, the formulation of the product and how the data requirements will be addressed. Delays can be avoided by submitting quality packages in the initial submission and working hand-in-hand with EPA during the review process. TSG can provide time estimates for the preparation of the pesticide application package as well as an estimate of EPA’s time to review the application package once it is submitted to EPA.
The data requirements that are needed for an EPA pesticide registration are dependent on the proposed product uses including location and claims made on the labeling. The formulation of the proposed product can also impact the type of data required. There are many ways the data requirements can be addressed such as data citation, waiver rationales and lab generation. The data requirements for pesticides can be found in 40 CFR Part 158. TSG can provide a list of data requirements specific to your proposed product through a registration strategy assessment document or a data gap analysis.
The costs and fees that go into getting a pesticide registered with EPA vary greatly depending on numerous factors. These factors include how the product will be used (for example, public health vs non-public health), the formulation of the product (for example, new active ingredient vs existing active ingredient in EPA’s database), and how the data requirements will be addressed (for example, data citation vs lab generation). TSG can provide cost estimates specific to the proposed product upon request.
Pesticide registrations with the EPA must be maintained throughout their life cycle through various obligations. EPA requires annual maintenance fees to be paid per product. Furthermore, if EPA issues a data call-in that is applicable to your product, the data call-in must be addressed by the product registrant. Occasionally, EPA issues other labeling and data mandates outside of the data call-in which must also be addressed. Lastly, if a registrant owns an EPA-registered establishment facility, annual reports are required to maintain the establishment registration. TSG can assist companies with the above-mentioned tasks as well as other EPA obligations.
Our regulatory specialists and scientists address all aspects of product registration and ongoing compliance. Read more about the individuals who make up our multi-disciplinary teams.
We work in various different markets, including agriculture, industrial, consumer and medical.