# Presentation: 024995

## Pesticide Registration Service Fees

- Overview of Pesticide Registration Improvement Renewal Act
- Marty Monell
- Deputy Office Director
- Office of Pesticide Program
- Pesticide Registration Improvement Renewal Act                    (PRIA2) Workshop
- November 27, 2007

## Pesticide Registration  Improvement Renewal Act (PRIA2)

- Coalition of Stakeholders (Farm Bureau, Registrants, Growers, Public Interest Groups) to ensure stable funding for OPP
- American Chemistry Council Biocides Panel
- Biotechnology Industry Organization
- Biopesticide Industry Alliance
- Chemical Producers & Distributors Association
- Consumer Specialty Products Association
- CropLife America
- International Sanitary Supply Association
- Natural Resources Defense Council
- Protected Harvest
- Responsible Industry for a Sound Environment

## PRIA2

- Highlights of changes to PRIA in PRIA2
- signed by the President October 9, 2007,
- retroactive to October 1, 2007
- Two Types of Fees
- Maintenance Fees
- Registration Service Fees

## Maintenance Fees

- Support Reassessment of registered pesticides
-  “Old Chemical program”
- Support Reregistration – complete reassessment of nonfood pesticide and product reregistration
- Under PRIA2 – Maintenance fees can be used for registration review

## Maintenance Fees

- Subsequent Registration Review
- Administrator shall complete a subsequent registration review for each pesticide or pesticide case
- This review will occur no later than 15 years after the date on which the initial review is completed
- Additional reviews to be completed each 15 years thereafter

##  Maintenance Fees

- $110 M to be collected over 5 years
- $22M per year
- Caps slightly increase
- FY08 → FY12 approximately $3M earmarked for fast tracks & new inert reviews

## Registration Service Fee “Enhanced Service”

- PRIA
- March 23, 2004  →  September 30, 2008
- PRIA2
- Implementation October 1, 2007
- Fees tied to specific decision completion timeframes

## Other Fees

- Cannot levy other registration fees
- Suspends authority to collect the tolerance petition fee through September 30, 2012

## PRIA Principles

- Consistent with Statute
- Ease of Implementation
- Fairness
- Transparency

## Timeframes and Fees

- 90 to 140 fee categories
- Applications now covered by PRIA2
- Protocols
- Waivers
- Refined eco/endangered species
- Uncleared inerts in products

## Timeframes and Fees

- Timeframes further reduced for reduced risk
- Fees:
- FY08 increased for conventional applications, same for others from FY07
- FY09 - +5% increase
- FY11 - +5% increase

## Fee Payments

- Full fee payment at time of submission
- Developed web information
- All requests for small businesses waivers must include partial payment of at least 25% fee
- Additional fees may be billed:
- Incorrect fee and decision review period
- Waiver request denied
- Different fee and decision review period determined

## Fee Payment

- Refund if too much is paid
- 25% of fee nonrefundable
- If application is rejected, Agency will retain 25% of fee

## Fee Payment

- If no payment is received 30 days after fee is due, fee will be treated as claim of the US Government (subchapter II of chapter 37 of title 31)
- Applications received by EPA as of October 1, 2007 fall under PRIA2, earlier applications continue under PRIA
- Interim invoicing application received during October to allow applicants time to become familiar with new payment process

## Waivers: Small Business

- If applicant provides adequate documentation demonstrating that it qualifies as a small business (i.e. average annual global gross pesticide revenues of less than $60M)
- 50% is waived
- If applicant provides adequate documentation demonstrating that it qualifies as a small business (i.e. average annual global gross pesticide revenues less than $10M)
- 75% is waived

## Waivers: Other

- IR-4
- Exempt if in conjunction with IR-4 petition and in the public interest
- Minor Uses
- May be waived or reduced
- Exempt from registration fees
- Agencies of Federal and State Government

## Withdrawal – Refunds	

- If application withdrawn within 60 days after start, then 75% of fee is refunded
- If application is withdrawn more than 60 days after start date, then refund based on % of work not completed
- Refunds can not exceed 75%
- Determination of the amount of the refund must be made within 90 days after the date of the withdrawal
- Formula  _[http://www.epa.gov/pesticides/fees/questions/waivers.htm](http://www.epa.gov/pesticides/fees/questions/waivers.htm)_

## Authority to Assess Fees

- Authority to assess fees is suspended if Congressional appropriations fall below the amount allocated to OPP in FY02 by more than 3%
- This protection applies for FY08 → FY12

## Start of the Decision                 Time Review Period

- Decision time review period begins 21 days after EPA receives the fee payment and application
- Administrator will perform an initial screening of contents of the application
- Application contains necessary forms, data, and draft labeling in accordance with the Administrator’s Guidance
- If application does not pass initial screening and cannot be corrected in 21 days, Administrator reject no later than 10 days after determination

## Start of the Decision                   Time Review Period

- For applications with a waiver
- Provided the 25% or 50% have been paid, clock starts when waiver is granted
- If denied, it starts when full payment is received

## Timeframes

- The timeframes established in PRIA are the MAXIMUM allowable timeframes.  In many cases, OPP is able to complete the registration prior to the PRIA due date
- PRIA provides expedited timeframes for “reduced risk” actions
- Can be extended by mutual agreement between registrant and EPA (i.e. negotiated due date)

## Negotiations

- Regulatory division/Registrant identifies the need to extend/renegotiate the decision time review period and reach agreement in writing on new due date
- The Deputy Office Director or Office Director gives decision if a new due date will be given

## PRIA Determination to Not-Grant

- Registering Division determines the application does not meet FIFRA standard for registration
- Involves missing data or information that makes it difficult for the Agency to predict the amount of time it will take to reach a decision on the action
- It completes a PRIA decision within the review timeframe and issued on a case by case basis
- The Office Director or Deputy Office Director signs the “PRIA determination to not grant” letter

## Judicial Review	

- Judicial review for new AIs & new uses where completion timeframe is exceeded by more than 2 years
- Covers only new AIs & new uses and only those for which a fee has been paid
- Can only be requested 2 years after the decision review period has expired

## Judicial Review

- Registrant must request a meeting with the Agency to try to work out the problem 4 months prior to petitioning for judicial review
- Judicial review remedy can NOT result in any fee refund

## Worker Protection

- Increase from PRIA
- To enhance scientific and regulatory activities, for FY08 → FY12, the Administrator shall use about 1/17th of the Fund (not less than $1,000,000)
- PRIA - $750K per year

## Other Initiatives

- Partnership grants – New
- FY08 and FY09 - $750K
- FY10 → FY12 - $500K
- Fund Pesticide Safety Education Program (PSEP) – New
- FY08 → FY12 – $500K

## Improvements

- Statutory Provision
- ...the Administrator shall identify and evaluate reforms to the pesticide registration process under this Act with the goal of reducing decision review periods in effect...
- Stakeholder Subcommittee of PPDC formed
- PPDC PRIA Process Improvement Workgroup

## Accounting

- Annual inspector general audit report detailing
-  amount of fees received,
-  expenditures from the fund,
-  decision making performance
-     achieved in comparison with decision
-     completion time periods, and
-  reasonableness of overhead costs
- IG report goes to Administrator and appropriate Congressional Committees

## Annual Reports

- # of applications reviewed and their individual decision timeframes
- # of label amendments reviewed using electronic means
- Amount of money from Reregistration and Expedited Processing Fund money used to carry out inert and similar application reviews
- # of applications completed for identical or substantially similar applications (and # completed within 90days)

## Annual Reports

- # of actions pending in each covered category including new inert petitions
- Progress made in meeting timeline requirements
- Description of staffing and resource allocations to support decision-making for covered actions

## Annual Reports

- Include as appropriate recommendations for:
- Expansion of self-certification
- Accreditation of outside reviewers
- Broadening the scope of the notifications process
- Electronic submission and review of labels
- Use of acute toxicity study summaries

## Annual Reports

- Use of Performance based contracts
- Review of progress of registration review
- # of pesticide or pesticide cases reviewed
- Staffing and costs related to Reregistration and Registration Review
- Recommendation for:
- Process improvements handling registration review
- Accreditation of outside reviewers
- Streamlining registration review process

## Annual Reports

- Review of timelines for Antimicrobials 3(h)
- Review of inert ingredients, including the number of applications pending, new applications, applications reviewed, staffing resources devoted to improve the timeliness
- Reports due March 1 (of each year) on the web
- _[http://www/](http://www/epa.gov/pesticides/fees/)__[epa.gov](http://www/epa.gov/pesticides/fees/)__[/pesticides/fees/](http://www/epa.gov/pesticides/fees/)_

## Phase Out

- Sunset – September 30, 2012
- In FY13, the first year of the phase out, fees are reduced by 40% from FY08 levels
- In FY14, the second year of the phase out, fees are reduced by 70% from FY08 levels

## PRIA2 Implementation

- IT systems modified
- Website – information updated
- Decision Tree
- PRIA2 on _[http://www.epa.gov/pesticides/fees/](http://www.epa.gov/pesticides/fees/)_
- Federal Register Notice Fee Schedule