Conventional pesticide and biopesticide registration (FIFRA)
Supporting EPA compliance for conventional pesticides and biopesticides
Navigating US pesticide registration requires a clear understanding of the EPA’s expectations under FIFRA. Whether you’re developing a conventional pesticide, a biologically based product , or an antimicrobial, Sagentia Regulatory provides tailored support to help you meet federal and state requirements. We guide clients through every stage of the regulatory process – from strategic planning and data development to submission and ongoing compliance – ensuring your products are positioned for approval and long-term success.
Conventional pesticide regulations
From registration strategy to annual reporting – comprehensive support for conventional pesticide compliance
Conventional pesticides are regulated by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). These products, based on traditional synthetic chemistry, are used to control, repel, mitigate, or eliminate pests across a wide range of applications including: crop protection, insect and insect vector control, professional pest control, home and garden pest management, and livestock and companion animal care.
At Sagentia Regulatory, we help clients navigate the full regulatory lifecycle of conventional pesticide products. These may be formulated as liquid emulsifiable and soluble concentrates, aerosol sprays, ready-to-use liquids, water-dispersible granules, dusts, or impregnated materials.
We support compliance across all major categories including: herbicides, insecticides, fungicides, rodenticides, nematicides, insect repellents, ectoparasiticides, plant growth regulators, and other vertebrate control agents.
For products intended for use on or in food – such as those applied to growing crops, post-harvest produce, or livestock – we guide clients through the process of establishing tolerances (maximum residue limits) or securing tolerance exemptions based on toxicology and residue chemistry data.
For products targeting public health pests (e.g. cockroaches, bed bugs, mosquitoes, ticks, flies, rodents), we assist in generating and submitting efficacy data to demonstrate their effectiveness against the target pest.
All conventional pesticide products must be registered with the EPA and in every US state where they are sold or distributed. We help clients meet these requirements through strategic planning, data development and submission support, ensuring compliance with FIFRA and state guidelines at every stage.
Biopesticide regulations
Tailored regulatory support for biologically based pest control products
Biopesticides are regulated by the US Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), but follow a distinct regulatory pathway from conventional pesticides due to their biological origin. These products are often favored for their targeted modes of action and environmental compatibility.
Sagentia Regulatory helps clients navigate the unique requirements for biopesticide registration, including:
- Biochemical pesticides – naturally occurring substances such as insect pheromones, natural plant and insect regulators, naturally occurring repellents and attractants and enzymes
- Microbial pesticides – living organisms like bacteria, fungi, viruses, or protozoa
- Plant-Incorporated Protectants (PIPs) – pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance
While biopesticides may benefit from reduced data requirements, they must still meet standards for chemistry, toxicology, and product performance – particularly for public health uses – under FIFRA guidelines.
For genetically modified microbial pesticides, we provide tailored guidance on the specific data requirements based on the organism, use pattern, and exposure potential.
All biopesticide products must be registered with the EPA and in each US state where they are marketed. Our experts work closely with clients to identify applicable data waivers, coordinate studies, prepare robust submissions, and develop regulatory strategies that streamline the registration process and ensure full compliance with FIFRA.
Helping you comply with pesticide and biopesticide regulations
Sagentia Regulatory provides science-led, strategic support for companies navigating the complex regulatory landscape for both conventional and biopesticide products. We can help you with:
- Developing tailored EPA pesticide product registration strategies
- Preparing and submitting federal and state registrations
- Securing Company Number and Establishment Numbers
- Conducting data gap analyses and supporting data compensation requirements
- Preparing and submitting pesticide inert ingredient petitions
- Coordinating studies with contract research organizations (CROs)
- Preparing data waiver rationales
- Supporting EPA pre-submission meetings
- Preparing biochemical classifications and non-FIFRA determinations
- Reviewing and developing product labels and claims
- Managing annual establishment reporting, and maintenance fees
- Conducting compliance audits and recordkeeping reviews
- Supporting product defense and consortia management for generic data
- Managing registration review
- Verifying inputs for databases including CDMS and Agrian
Your regulatory experts in
conventional and biopesticide products
Sagentia Regulatory’s team of scientists and regulatory consultants manage all aspects of product registration, lifecycle management, and strategic planning for conventional and biopesticide products. Key professionals supporting pesticide regulatory compliance include Jonathan Walsh who leads our Federal pesticide team and Wendy McCombie, who brings extensive experience in EPA registration strategy and FIFRA compliance.
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Frequently asked questions
How do I obtain an EPA conventional pesticide registration?
A conventional pesticide registration can only be obtained by providing US EPA with the information and data required by the Code of Federal Regulations. Every item submitted in support of registration must be completed and formatted in compliance with numerous guidelines. Novel conventional registrations normally require pre-consultation with EPA staff. Sagentia Regulatory’s scientific and regulatory consultants have extensive expertise in supporting clients in developing product registration strategies, as well as preparing and submitting federal applications.
Is Registration Review only important for technical grade active ingredient registrants?
Registration Review is the paradigm under which EPA continually reevaluates pesticide active ingredients to ensure their use patterns do not pose unreasonable risk to human health or the environment. While Registration Review is important to technical grade active ingredient registrants, this process is equally important to formulators who rely on registered technical grade active ingredient sources. Formulators need to be aware of Registration Review activities for the active ingredients they use to ensure that their product labeled uses continue to be acceptable and to timely respond to any required label changes. Sagentia Regulatory’s experts routinely support clients throughout the Registration Review process, reviewing and commenting on Preliminary and Final Workplans, assisting with responding to Product-Specific (PDCI) and Generic Data Call-ins (GDCI), responding to Interim Decisions, and reviewing labels to ensure compliance and advising on any label changes that are required.
Is there data protection for new active ingredients?
Novel pesticide active ingredients are commercialized after extensive research and development efforts, regulatory data development, and EPA review. Following registration, the data submitted to support each new active ingredient or new use is afforded a period of exclusive use where no other company can apply for registration without obtaining written authorization from the original data submitter. Navigating data compensability issues and understanding data requirements can at times be challenging. Sagentia Regulatory’s scientific and regulatory consultants can assist in the review of relevant databases to inform you of likely compensable data hurdles.
How is EPA being protective of pollinator species in its evaluation of pesticides?
EPA has several honeybee toxicity requirements that must be addressed for pesticide active ingredients with outdoor use patterns. In recent years however, there has been a broader awareness of the potential impacts on sensitive pollinator species to select insecticidal active ingredients. Those neonicotinoid insecticides were required to develop additional pollinator protection data and some of required studies are “non-guideline”, meaning that there is no standard EPA guideline published. A total of five “tier 1” studies are now being required on virtually all insecticidal active ingredients with outdoor use patterns: honeybee acute contact toxicity; honeybee adult acute oral toxicity; honeybee larval acute oral toxicity; honeybee adult chronic oral toxicity; honeybee larval chronic oral toxicity; and residual toxicity on treated foliage. EPA will likely be requiring, at minimum, these tier 1 pollinator protection studies on other herbicidal and fungicidal active ingredients as well. If your company is in the position of needing to respond to an EPA Data Call-In or is required to generate pollinator protection data, Sagentia Regulatory’s scientific and regulatory consultants can assist in the placement, monitoring, and review of those studies at qualified contract research organizations.
Does my product qualify as a biopesticide, and does it require EPA registration?
If your product is intended to control pests via a non-toxic mode of action and contains naturally derived ingredients – such as microbes, plant extracts, or biochemical compounds – it likely qualifies as a biopesticide under the US Environmental Protection Agency (EPA) guidelines. In most cases, this means it must be registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) before it can be legally sold or distributed in the US. Determining the correct classification early is essential to avoid regulatory missteps and delays.
What if my product is classified as a conventional pesticide instead of a biopesticide?
If the EPA determines that your product does not meet the criteria for a biopesticide – perhaps due to its synthetic origin, broad-spectrum activity, or lack of a natural mode of action – it will be regulated as a conventional pesticide. This classification typically involves more extensive data requirements, including chronic toxicology, environmental fate, and residue studies. The review process may also be longer and more costly. Early identification of your product’s regulatory pathway is critical to avoid delays and ensure compliance with all applicable EPA standards.
What data and steps are required for EPA biopesticide registration?
The EPA requires a comprehensive data package that typically includes:
- Product composition and manufacturing details
- Toxicology and environmental safety data
- Efficacy studies (especially for public health claims)
- Proposed product labeling
The process begins with a pre-submission consultation with the EPA’s Biopesticides and Pollution Prevention Division (BPPD), followed by formal submission and review under PRIA timelines. Each step must be carefully managed to ensure compliance and avoid costly delays.
What are common reasons for registration delays or denials?
Some of the most frequent pitfalls include:
- Misclassifying the product (e.g., as a biostimulant or conventional pesticide)
- Incomplete or inconsistent data submissions
- Overstated or misleading label claims
- Failing to engage in a pre-submission meeting
- Overlooking state registration requirements
Avoiding these issues requires a clear regulatory strategy and attention to detail.
What is the proposed Plant Biostimulant Act of 2025 and why does it matter?
The proposed Plant Biostimulant Act of 2025 clarifies that biostimulants – products that enhance plant health or nutrient use without directly affecting growth – are not regulated as pesticides under FIFRA. This distinction helps manufacturers avoid unnecessary EPA registration, provided their product claims stay within defined limits. For companies developing innovative plant health solutions, understanding this law is essential to ensure compliance and accelerate time to market. Sagentia Regulatory can help you determine whether your product qualifies and guide you through the correct regulatory pathway.
As of June 16, 2025 – this bill has been introduced in both houses of the Congress, but is not an effective law.