PRIA Overview and History
- Pesticide Registration Improvement Act (PRIA 1)
- Pesticide Registration Improvement Renewal Act (PRIA 2)
- Pesticide Registration Improvement Extension Act (PRIA 3)
- Pesticide Registration Improvement Extension Act of 2018 (PRIA 4)
Effective March 8, 2019, the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) reauthorized the Pesticide Registration Improvement Act (PRIA) for five years, through fiscal year 2023. This page provides background on PRIA and explains changes and continuities across PRIA 1, 2, 3, and 4.
Pesticide Registration Improvement Act (PRIA 1)
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.
Pesticide Registration Improvement Renewal Act (PRIA 2)
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 and pesticide safety education programs.
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.
Pesticide Registration Improvement Extension Act (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. PRIA 3:
- Expanded number of fee categories of registration applications from 140 to 189.
- Inert clearances (I codes) included as covered PRIA categories.
- Miscellaneous categories included as covered PRIA categories.
- Established significant footnotes for covered PRIA categories.
- Continued funding for farm worker protection activities.
- Continued funding for partnership grants and pesticide safety education programs.
- Established funding for IT enhancements. (from maintenance fees)
- Continued 50% and 75% fee waiver reductions for small businesses.
- Continued exemption from requirement of fee for Federal/State agencies and for applications associated with IR-4 that meet certain criteria.
- Provided for maintenance fee reduction for certain small businesses.
- Process improvements in receiving PRIA application and for clear labels and label issue resolution period established.
Process Improvements
- 45/90 Preliminary Technical Screen.
- Clean label/Label Resolution Period (RD, AD only).
- IT enhancements.
Preliminary Technical Screen
The Preliminary Technical Screen allowed 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 included 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 applied 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 provided a draft accepted label to applicant on or before the PRIA due date. The applicant:
- Agreed to all of the terms associated with draft accepted label.
- Did not agree to one or more terms and requested additional time to resolve difference(s).
- Withdrew the application without prejudice for subsequent resubmission, but forfeited the associated registration service fee.
An applicant who requested additional time to resolve differences had up to 30 days to reach agreement with the Agency on the final terms of the EPA-accepted label. If agreement was reached, EPA had two business days after submission of the revised label to review and approve the final stamped label.
IT Enhancements
PRIA 3 provided funding for and required 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.
Miscellaneous Changes
- PRIA 3 due dates that fell on a weekend or holiday were extended to the next business day.
- There was 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 was subject to its registration service fee, as was 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 was subject to 25% of the related fee for "new active ingredient and first food use" category.
- If an application was associated with and dependent upon a pending inert ingredient approval, the decision time line for the associated application was extended to match the PRIA due date of the pending inert action, unless the due date for the associated action was further out, in which case it was 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 was assessed.
Pesticide Registration Improvement Extension Act of 2018 (PRIA 4)
Effective March 8, 2019, the Pesticide Registration Improvement Extension Act of 2018 (PRIA 3) reauthorized the Pesticide Registration Improvement Renewal Act (PRIA 3) for five years, through 2023. PRIA 4:
- Expands the number of covered categories from 189 to 212;
- Provides enhanced financial incentives for reduced-risk submissions;
- Continues small business fee waivers as well as exemption for federal and state agencies and IR-4 applications that meet certain criteria;
- Continues PRIA set-aside for farm worker protection activities, partnership grants and pesticide safety education programs;
- Raises the annual maintenance fee collection target from $27.8 million to $31 million;
- Eliminates appropriations constraint (the “1-to-1” provision) on spending FIFRA maintenance fees;
- Creates two new maintenance fee set-asides (up to $500,000/year for each, from 2018 through 2023) for:
- efficacy guideline development and rulemaking for invertebrate pests of significant public health or economic importance;
- Good Laboratory Practices (GLP) inspection support;
- Eliminates maintenance fee set-aside for IT enhancements;
- Establishes new reporting requirements for (a) efficacy guidelines and rulemaking deliverables (b) GLP inspections (c) registration review mitigation implementation (d) identification of reforms to streamline new a.i. and new use review processes, (e) registration of pesticides to control vector-borne public health pests, and (e) EPA and stakeholder evaluation of the appropriateness and effectiveness of worker protection activities, partnership grants, and pesticide safety education programs funded under the PRIA set-aside.