Overview of U.S. Pesticide Regulations
- 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:| EPA No. | Action | Decision Review Time (Months) | FY'25-FY'26 Registration Service Fee ($) |
| R010 | New active ingredient; Food use | 36 | 1,133,324 |
| R020 | New active ingredient; Food use; reduced risk | 27 | 944,438 |
| R060 | New active ingredient; Non-food use; outdoor | 30 | 787,381 |
| R070 | New active ingredient; Non-food use; outdoor; reduced risk | 24 | 656,151 |
| R110 | New active ingredient; Non-food use; indoor | 20 | 437,923 |
| R120 | New active ingredient; Non-food use; indoor; reduced risk | 14 | 364,934 |
| R122 | Enriched isomer(s) of registered mixed-isomer active ingredient | 27 | 477,253 |
| R123 | New active ingredient; Seed treatment only; includes agricultural and non-agricultural seeds; Non-food use; not requiring a tolerance | 27 | 710,111 |
| R126 | New active ingredient; Seed treatment only; limited uptake into raw agricultural commodities; use requiring a tolerance | 31 | 781,122 |
| EPA No. | Action | Decision Review Time (Months) | FY'25-FY'26 Registration Service Fee ($) |
| R040 | New active ingredient; Food use; Experimental Use Permit application | 18 | 696,028 |
| R090 | New active ingredient; Non-food use; outdoor; Experimental Use Permit application | 16 | 487,127 |
| R121 | New active ingredient; Non-food use; indoor; Experimental Use Permit application | 18 | 274,389 |
| R125 | New active ingredient; Seed treatment; Experimental Use Permit application | 16 | 487,127 |
| EPA No. | Action | Decision Review Time (Months) | FY'25-FY'26 Registration Service Fee ($) |
| B580 | New active ingredient; petition to establish a tolerance | 22 | 76,382 |
| B590 | New active ingredient; petition to establish a tolerance exemption | 20 | 48,024 |
| B600 | New active ingredient; no change to a permanent tolerance or tolerance exemption (includes non-food use) | 15 | 28,816 |
| EPA No. | Action | Decision Review Time (Months) | FY'25-FY'26 Registration Service Fee ($) |
| A380 | New active ingredient; indirect food use, establish tolerance or tolerance exemption if required | 26 | 239,355 |
| A390 | New active ingredient; Direct food use, establish tolerance or tolerance exemption if required | 26 | 345,729 |
| A410 | New active ingredient; Non-food use | 23 | 292,592 |
| A431 | New active ingredient; Non-food use; indoor; low-risk | 14 | 120,734 |
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
Ways to Satisfy Data Requirements
- 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.
- 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.
- Expert Assessment: Certain data requirements, such as exposure assessments, may be satisfied through evaluations conducted by qualified experts in the relevant field.
- 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| Number of employees | Average Annual Revenue from Pesticides | Waiver |
| 500 or fewer | ≤ $60 million | 50% |
| 500 or fewer | ≤ $10 million | 75% |
Our Services
- Establishment Registration
- Initial and Annual Report Submission
- U.S. EPA New Product/Similar Product Pesticide Registration
- U.S. EPA Pesticide Data Compensation Fee Evaluation
- U.S. EPA Pesticide Device Registration
- Minimum Risk Pesticides Compliance
- U.S. EPA Official Pre-Application Meeting (pre-application meeting)
- 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.
