PRIA Overview and History
- Pesticide Registration Improvement Act (PRIA 1)
- Pesticide Registration Improvement Renewal Act (PRIA 2)
- Pesticide Registration Improvement Extension Act (PRIA 3)
- What's new in PRIA 3?
Effective October 1, 2012, the Pesticide Registration Improvement Extension Act (PRIA 3) reauthorized the Pesticide Registration Improvement Renewal Act of 2007 (PRIA 2) for five years, until 2017. This page provides background on PRIA and explains changes and continuities across PRIA 1, 2 and 3.
The Consolidated Appropriations Act of 2004 established a new system for registering pesticides, called the Pesticide Registration Improvement Act, or PRIA. The new section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) created a registration service fee system for applications for specified pesticide registration, amended registration, and associated tolerance actions, which set maximum residue levels for food and feed.
The Environmental Protection Agency (EPA) was required to make a determination on the application within the decision times specified. Fees covered 90 different categories of registration applications. PRIA also provided funding for worker protection activities.
Fee Waivers under PRIA 1
- Fee waivers for small businesses:
- 50% fee waiver for businesses with < 500 employees and ≤ $60 M in global pesticides sales.
- 75% fee waiver for businesses with < 500 employees and ≤ $10 M in global pesticide sales.
- 100% fee waivers to federal/state agencies and IR-4 submissions that meet criteria specified in FIFRA.
- Voluntary payment for registration action under review at the time of passage of PRIA 1.
PRIA 1 Funding for Worker Protection Activities
- $750,000 to 1 million per year. Funding for:
- Surveys on farm worker employment, health, living conditions, demographics.
- State oversight of farm worker illnesses and injuries.
- Training programs and materials for farm workers to reduce risks of pesticide use.
- Training for health care providers to recognize and treat pesticide poisonings.
Congress reauthorized PRIA effective October 1, 2007, the beginning of Fiscal Year 2008. The Pesticide Registration Improvement Renewal Act (PRIA 2) authorized the fee system until September 30, 2012. PRIA 2:
- Expanded the number of fee categories of registration applications from 90 to 140.
- Continued funding for farm worker protection activities.
- Established funding for partnership grants.
- $500,000-750,000 per year.
- Administered under Pesticide Environmental Stewardship Program.
- Used in conjunction with appropriated funds to support innovative Integrated Pest Management projects that help to reduce pesticide risk.
Effective October 1, 2012, the Pesticide Registration Improvement Extension Act (PRIA 3) reauthorized the Pesticide Registration Improvement Renewal Act of 2007 (PRIA 2) for five years, until 2017. PRIA 3:
- Expands number of fee categories of registration applications from 140 to 189.
- Continues funding for farm worker protection activities.
- Continues funding for partnership grants.
- Establishes funding for IT enhancements.
- Continues 50% and 75% fee waiver reductions for small businesses.
- Continues exemption from requirement of fee for Federal/State agencies and for applications associated with IR-4 that meet certain criteria.
- Provides for maintenance fee reduction for certain small businesses.
|PRIA 3 Continuities||PRIA 3 Changes|
|50% and 75% fee waiver reductions for small businesses||
New categories added and some old categories deleted:
|Exemption from requirement of fee for federal/state agencies and for applications associated with IR-4 that meet certain criteria||Some decision review timelines increased (33); one decreased|
|Funding for farm worker protection activities||Process improvements|
|Funding for partnership grants||Funding for IT enhancements|
Significant footnote additions to covered PRIA categories
PRIA 3 creates new categories for the three regulatory divisions (A, B, R codes), inert clearances (I codes), and miscellaneous actions (M codes). This is designed to increase consistency among the three regulatory divisions, capture additional actions where data review is required, and encourage adoption of updated crop groups in tolerances and on labels.
Some categories are deleted based on either lack of use or inclusion in a new category. All inert clearances are now subject to the fee-for-service structure and set decision time lines (in PRIA 2, only inert clearances associated with new product applications were subject to the fee-for-service process).
A new “Miscellaneous Table” includes:
- Applicant-initiated requests for external review (HSRB, SAP).
- Requests for extension of the exclusive use period.
- Gold Seal letters.
Decision Review Timelines
Some decision timelines are increased to address high rates of renegotiation experienced under PRIA 2 (e.g., new product applications), as well as to allow adequate time for label resolution period (33 increased). One timeline decreased.
- 45/90 Preliminary Technical Screen.
- Clean label/Label Resolution Period (RD, AD only).
- IT enhancements.
Prelininary Technical Screen
The Preliminary Technical Screen allows the Agency to identify deficiencies early in the application process and allows the applicant a 10-day period to correct these deficiencies at the front end of the review process.
- A 45-Day technical deficiency screen time frame for actions with decision review timeline of 6 months or less.
- A 90-day technical deficiency screen time frame for actions with decision review timeline of greater than 6 months.
- Deficient applications that are not corrected may be rejected, thus freeing up Agency resources for those applications that can proceed toward a regulatory decision.
These screens augment the 21-Day Completeness Screen established under PRIA 2, which checks to make sure all components of the application are present. This completeness screen does not include evaluation of quality of submission.
Clean Labels/Two-Day Label Review
PRIA 3 includes a provision to ensure “clean” labels. Previously, some labels may have been approved by EPA with numerous conditions. The label conditions were placed on the accompanying label amendment, which made state enforcement of the labels more difficult. This will apply to registration applications submitted under PRIA 3.
Label Resolution Period
The label resolution period applies to RD and AD actions only, and only to actions submitted under PRIA 3. EPA provides a draft accepted label to applicant on or before the PRIA due date. The applicant:
- Agrees to all of the terms associated with draft accepted label.
- Does not agree to one or more terms and requests additional time to resolve difference(s).
- Withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee.
An applicant who requests additional time to resolve differences has up to 30 days to reach agreement with the Agency on the final terms of the EPA-accepted label. If agreement is reached, EPA has two business days after submission of the revised label to review and approve the final stamped label.
PRIA 3 provides funding for and requires EPA to:
- Develop electronic tracking of registration submissions.
- Develop tracking of status of conditional registrations.
- Enhance the endangered species database.
- Allow for electronic submission and review of labels and confidential statements of formula.
- PRIA 3 due dates that fall on a weekend or holiday are now extended to the next business day.
- There is a limitation on the number of new product applications (5) with a new active ingredient or first food use application; each additional new product application is subject to its registration service fee, as is a new inert approval submitted with the new a.i. or first food use package.
- Applicant-initiated information submitted after completion of the technical deficiency screen is subject to 25% of the related fee for "new active ingredient and first food use" category.
- If an application is associated with and dependent upon a pending inert ingredient approval, the decision time line for the associated application will be extended to match the PRIA due date of the pending inert action, unless the due date for the associated action is further out, in which case it will be subject to its own decision review time line.
- There is a similar approach for applications associated with and dependent upon external review (Human Studies Review Board, Scientific Advisory Panel).
- If an inert approval application covers multiple inert ingredients grouped by EPA into one chemical class, a single registration service fee may be assessed.