Pesticide Registration in the U.S.: Navigating New Active Ingredient Registration with the EPA

In the United States, the Environmental Protection Agency (U.S. EPA) is the primary regulatory authority for pesticides. As a result, pesticide regulations in the U.S. are commonly referred to as U.S. EPA regulations. The cornerstone of pesticide regulation in the U.S. is the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

FIFRA provides federal regulation of pesticide distribution, sale, and use, outlining the specific requirements for pesticide registration within the U.S.. All pesticides intended for distribution, sale, or use in the U.S. must first be registered under FIFRA. This regulation applies to conventional pesticides, biopesticides, and antimicrobial pesticides (including disinfectants), including manufacturing use products, end-use products, and the related inert ingredients (e.g., solvents, stabilizers, and safeners).

In addition to FIFRA, two additional key regulations are related to pesticide registration:

• Pesticide Registration Improvement Act (PRIA): Enacted to complement FIFRA, PRIA provides detailed application rules, decision review time, and associated registration service fees for different pesticide registration types. PRIA 1 was initially enacted in 2003, and subsequently updated through PRIA 2 in 2007, PRIA 3 in 2012, PRIA 4 in 2019, and the most recent PRIA 5 in December 2022. PRIA 5 currently encompasses 226 pesticide registration types, covering various categories such as new active ingredients, new uses, and new product registrations.
• 40 CFR (Code of Federal Regulations, Title 40): The regulations relevant to pesticides are located within Title 40 of the CFR, specifically the Environmental Protection regulations, also known as 40 CFR. This section provides detailed guidance on the pesticide registration processes, data requirements, data protection regulations, and other aspects related to pesticide registration, essentially serving as the practical implementation manual for FIFRA.

New Active Ingredients Registration Types

Various registration types are related to new active ingredients registration for different pesticide categories in the U.S.: conventional pesticides, biopesticides, and antimicrobial pesticides.

For conventional pesticides, the PRIA actions include:

For each new active ingredient registration, a maximum of 5 end-use product registrations can be submitted simultaneously in a single application, while the review decision time and registration service fee remain unchanged.

Additionally, an Experimental Use Permit must be applied before conducting certain tests for the new active ingredient registration of conventional pesticides. The related PRIA actions are as follows:

For biopesticides, due to their generally lower toxicity and the fact that they are a type of pesticide encouraged by the Agency, there are significant discounts on the registration fees. The related PRIA actions for new active ingredient registration are as follows:

For antimicrobial pesticides, the related PRIA actions for new active ingredient registration are as follows:

Data Requirements for New Active Ingredient Registration

According to the data requirements in 40 CFR, two sets of data should be submitted for a new active ingredient registration: generic data and product-specific data. The data requirements are as follows:

• Product Chemistry
• Toxicology
• Ecological Effects
• Human Exposure
• Spray Drift
• Environmental Fate
• Residue Chemistry
• Product Performance

It is worth noting that for pesticides that are not related to public health, such as conventional pesticides, the U.S. EPA may waive the product performance data during product registration. However, the applicant must have the data to support claims on the label when used according to the labeled instructions. The U.S. EPA reserves the right to request efficacy reports from the registrant at any time.

Ways to Satisfy Data Requirements

1. Data Generation: When existing data suitable for citation is unavailable, the applicant must commission a laboratory to conduct the studies. The U.S. EPA mandates that all the studies be conducted by laboratories complying with GLP (Good Laboratory Practice) standards.
2. Waiver Request Data requirements may be waived based on the specific characteristics of the product. Applicants must provide robust scientific rationales to support a waiver request.
3. Expert Assessment: Certain data requirements, such as exposure assessments, may be satisfied through evaluations conducted by qualified experts in the relevant field.
4. Data Citation: For new active ingredients, particularly biopesticides, some data requirements can be complied by citing publicly available literature.

Pre-Application Meetings for New Active Ingredient Registration

The registration of new active ingredients often involves a significant volume of data requirements, which can lead to numerous questions for applicants during the preparation of their registration dossier. To facilitate a smoother and more efficient registration process, we strongly recommend that applicants request a pre-application meeting with the Agency before the formal submission of the dossier or prior to the initiation of key studies. The purpose of this pre-application meeting is to provide an opportunity for applicants to clarify any uncertainties they may have regarding proposed labeling, specific data requirements, appropriate testing methodologies, and other aspects of the registration process.

Data Protection

To protect the interests of data submitters, the U.S. EPA provides certain rights to protect the data submitted to the Agency in pesticide registration. The protection depends on the type of data.

Exclusive-Use Data

According to FIFR section 3(c)(1)(F), data submitted after September 30, 1978, for the initial registration of a new active ingredient, a new combination of active ingredients, or for the addition of a new use to amend an original registration, is considered exclusive-use data.

Exclusive-use data is protected for 10 years from the original registration date of the pesticide. During this 10-year data protection period, any applicant seeking to cite the exclusive-use data in support of a pesticide registration with the U.S. EPA must obtain written authorization from the original data submitter.

Compensable Data

Data submitted for a new product registration, an amendment to add a new use to an existing product registration, registration, and registration review of an existing product is considered compensable data.

Compensable data is protected for 15 years from the submission date and no longer retains exclusive-use protection. During this protection period, any applicant intending to cite this data must send a notification to the original data submitter, indicating a willingness to pay data compensation fees. Upon sending the “offer-to-pay” letter, the applicant can cite the data for pesticide registration without obtaining authorization from the original data submitter.

For New Active Ingredient Registration, the data used for the initial registration is considered exclusive-use data and is protected for 10 years from the date of registration. Following the expiration of the 10-year exclusive data protection period, the data typically continues to be protected for the remaining duration of the 15-year compensable data protection period.

PRIA Fee Waivers for Small Businesses

To support small businesses in the pesticide registration process, the Agency may provide a partial waiver of the registration fee. This fee waiver policy is also applicable to companies located outside the U.S. Eligibility for a PRIA fee waiver is determined based on a small business’s number of employees and their average annual global gross revenues from pesticides, according to the following criteria

Our Services

• Establishment Registration
• Initial and Annual Report Submission
• U.S. EPA New Active Ingredient Pesticide Registration
• U.S. EPA New Product/Similar Product Pesticide Registration
• U.S. EPA Pesticide Data Compensation Fee Evaluation
• U.S. EPA Pesticide Device Registration
• U.S. EPA Pesticide Inert Ingredient Registration
• Minimum Risk Pesticides Compliance
• U.S. EPA Official Pre-Application Meeting (pre-application meeting)
• U.S. EPA State Registration
• U.S. EPA Distributor Registration
• Pesticide Product Compliance Analysis/Data Gap Analysis Report
• U.S. Domestic Agent Annual Services
• Data Compensation Scheme Development and Negotiation with Data Owners
• Data Evaluation/Data Gap Analysis/Waiver Analysis
• Regulatory Consulting and Customized Training Services

Q&A

Could you provide clarification on the meaning of “Registered Active Ingredient”?

There are two scenarios when determining whether an active ingredient is “registered”, namely, a “registered active ingredient” and a “registered source” of a pesticide product, which are often confused:

• When determining whether the product contains a “registered” Active Ingredient: This refers to whether the active ingredient is currently contained in EPA-registered pesticide products. If it is, it’s considered an existing or “registered” active ingredient; otherwise, it is a new active ingredient.
• When determining whether the active ingredient of an end-use product is from a “registered source”: This refers to whether the specific active ingredient produced by a manufacturer has been registered by the U.S. EPA for use in pesticide products.

Is there any difference between registering a pesticide for agricultural use and non-agricultural use of the same active ingredient, especially regarding registration time, cost, and complexity?

 The essential difference between agricultural and non-agricultural use of pesticides lies in their intended application scenarios. The key factor affecting the registration of these two categories is whether it is for food use purposes.

Generally speaking, pesticide registration for food use tends to have a longer timeline, higher cost, and greater complexity compared to non-food use pesticides. This is principally due to the requirement for residue data and the establishment of tolerance or tolerance exemptions for food use.

For a specific active ingredient being registered for food use for the first time, the registration process is generally more challenging than for non-food use. However, if an existing product already has registrations for both food and non-food uses, the complexity of registering a new product for different uses would likely not differ significantly.