Man spraying pesticides ontop of crops on a field

PESTICIDES: SCIENTIFIC AND REGULATORY SUPPORT

Federal EPA (FIFRA) Regulatory Support

Successfully registering pesticide products in the U.S. requires navigating the complex regulatory landscape of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). toXcel helps clients bring conventional, antimicrobial, and biopesticide products to market efficiently and in full compliance with U.S. Environmental Protection Agency (EPA) regulations.

Our team of regulatory scientists and former EPA reviewers and managers provides expert guidance through all stages of the pesticide registration process—from strategic planning to submission and post-registration support.

We Support All Product Types Regulated Under FIFRA, Including:

New Active Ingredients (Technical Grade Active Ingredient, TGAI)
Manufacturing Use Products (MUPs)
End-Use Products (EPs)
Substantially Similar Products (“Me-too” Registrations)
Experimental Use Permits (EUPs)
Conventionals, Antimicrobials, and Biopesticides
Herbicides, Insecticides, Fungicides, Nematicides, Fumigants

Our FIFRA Services Include:

Development and review of product labels in accordance with EPA requirements
Preparation and submission of registration applications, amendments, and notifications
Drafting and filing of tolerance petitions and inert ingredient petitions
Conducting human health and environmental risk assessments
Designing, monitoring, and interpreting GLP-compliant laboratory studies
Performing data gap analyses and preparing data waiver justifications
Managing data development, cost-sharing, and compensation agreements
Serving as an authorized U.S. agent or representative
Managing state registration applications and maintenance
Handling continuing registration efforts (e.g., Data Call-Ins, Registration Review, and Annual Maintenance Fees)

Why Choose toXcel?
Our deep experience in EPA regulatory pathways, combined with technical excellence in toxicology, exposure modeling, and data strategy, ensures your products meet federal and state requirements while avoiding costly delays.

State Regulatory Support

Many products are regulated at both the Federal and State level in the US and toXcel has extensive experience in navigating the State regulations for a variety of products including pesticides (chemicals, including new active ingredients, and devices), biostimulants, and fertilizers.

toXcel routinely submits regulatory applications on behalf of clients to help bring products to market, including new active ingredients, and maintain regulatory compliance. Activities include submission of registration applications, registration updates, sales reporting, and registration renewals. toXcel staff advocate on behalf of and routinely work with clients to monitor the ever-changing regulatory landscape to ensure products are up to date and companies are kept abreast of regulatory developments that may impact their product lines.

Expert Witness and Litigation

When science is central to your legal case, toXcel delivers credible, defensible expertise grounded in decades of regulatory and toxicological experience.

Our scientific and regulatory staff have extensive experience in development and presentation of expert opinions for litigation cases, including toxic torts. Our senior staff have developed expert reports for submission in a broad range of cases. Our experts have testified at deposition and trial, and have undergone direct examination, cross-examination, and rebuttal on scientific and regulatory issues related to the cases. We have represented both defendants and plaintiffs through the application of sound scientific principles.

Study Placement, Due Diligence, & Compliance Audits

toXcel helps clients ensure scientific integrity and regulatory readiness by providing expert oversight of study design, data quality, and compliance with applicable regulatory standards. Our goal is to reduce risk, avoid costly delays, and strengthen the foundation of your product registration or acquisition strategy.

We assist in identifying required studies based on product type and chemical properties, overseeing study placement and monitoring at trusted contract research organizations (CROs), and evaluating results across a range of disciplines—including toxicology, environmental fate, ecotoxicology, and physical/ chemical properties.

Our Services Include:

Study planning, placement, and monitoring at qualified CROs
Data review and interpretation for regulatory impact and submission readiness
On-site Good Laboratory Practice (GLP) audits to ensure compliance with EPA, FDA, and international regulatory standards
Regulatory due diligence and compliance assessments for self-audits, acquisitions, or licensing
Detailed reviews of internal files to identify regulatory gaps and vulnerabilities

As experts in regulatory compliance, toXcel provides clients with due diligence and compliance assessments tailored to your individual needs. Whether you are looking to conduct a self-audit or considering a merger or acquisition, toXcel brings the expertise you need to make confident decisions, maintain compliance, and support successful product development and business transactions.

FIFRA 101 Training

Understanding the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is essential for companies developing or marketing pesticide products in the US. Whether you’re onboarding new staff, launching anew product line, or aligning your leadership team on regulatory expectations, toXcel’s tailored FIFRA 101training gives your team the practical knowledge needed to succeed.

Our expert-led workshops are fully customized to your company’s specific products, regulatory challenges, and strategic goals. From the basics of FIFRA compliance to regulatory strategy, we design training that delivers actionable insights you can apply to your goals.

Our FIFRA Training Covers:

Introduction to FIFRA: Key concepts, structure, and regulatory authority
Overview of pesticide product registration, data requirements, and regulatory options and limitations
Strategic guidance for product development under FIFRA
Regulatory planning tailored to your company’s product portfolio and unique objectives
Live Q&A with seasoned regulatory professionals

Training can be delivered on-site at your facility, remotely, or at toXcel’s Gainesville, VA headquarters,depending on your team’s needs.

Let us equip your team with the knowledge to make informed regulatory decisions, reduce compliance risk, and better communicate with regulators and stakeholders.

White Papers and Other Downloadable Resources

mockup image of a Pesticide Registrations in the United States white paper

Image of toXcel team members outdoors from a company retreat.

Our team members are what make us great!

toXcel boasts a gender-inclusive workforce with a higher representation of women, reflecting our commitment to diversity and equality. Over 65% of our team identifies as female.