PRIA 2

1. PRIA 2 Overview of Pesticide Registration Improvement Renewal Act for Antimicrobials November 27, 2007

2. Topics for Discussion • New Fees • New Fee Categories • New Numbering System • No 100% Fee Waivers • New Action Codes

3. Topics for Discussion (cont’d) • How an Application is Processed • 21-day Completeness Review • 75-day letters • Negotiations • Not Grant Letters

4. Timeframes and Fees • 90 to 140 fee categories • Applications now covered by PRIA2 • Protocols • Waivers • Refined eco/endangered species • Cancer Reassessment • Reduced risk ai’s for AD

5. Timeframes and Fees • Fees: • FY08 increased for conventional applications, same for others from FY07 • FY09 - +5% increase • FY11 - +5% increase

6. Fee Payments • Full fee payment at time of submission • Web site enhanced included Decision Tree • 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

7. Fee Payment • Refund if too much is paid • 25% of fee nonrefundable • If application is rejected, Agency will retain 25% of fee

8. Start of the Decision Time Review Period • Decision time review period begins 21 days after EPA receives the fee payment and application • An initial screening of contents of the application will be performed • 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

9. 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

10. New Numbering System for Action Codes • Current action codes changed in that a “0” has been added to each code • A38 is now A380 • A42 is now A420 and so forth • No codes have been removed but some new ones have been added

11. New AD Categories

12. A431 • Non-food use; indoor; low-risk and low-toxicity food–grade active ingredient(s), efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol • Decision time frame – 12 mo • Fee - $55,000

13. A431 • An application that proposes an indoor non-food use for a low risk/low toxicity food grade active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. A non-food use includes a proposed use that is not a “food use” as described in the food use categories. The product is for use inside a manmade structure. Low risk/low toxicity food grade active ingredients are those described in PR Notice 2000-6. (www.epa.gov/PR_Notices/pr2000-6.pdf).

14. A431 • Other active ingredients proposed as low risk/low toxicity will be considered on a case–by-case basis. A product making public health claims require efficacy be submitted using a protocol that AD has approved or using a standardized AOAC, ASTM or OECD protocol. DSS/TSS protocols can be found athttp://www.epa.gov/oppad001/sciencepolicy.htm. Other protocols that AD has approved are found athttp://www.epa.gov/oppad001/regpolicy.htm. All studies must be completed under GLP.

15. A521 • Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process ; Applicant initiated; Tier 1 • Decision time frame • 1st year – 6 mo • 2nd year – 4 mo • 3rd year and after – 3 mo • Fee - $2,000

16. A521 • An application that requires the review of a modified public health efficacy protocol where only minor changes are made to an exiting efficacy method. • The proposed protocol is similar to an existing approved protocol. • Existing methods are those established by ASTM, AOAC or AD approved methods described in A431. • Study design can be reviewed and approved within AD.

17. A521 • A draft label with proposed directions for use and marketing claims must accompany the application. • Protocol review and approval must be completed before an application for registration is submitted that includes efficacy data generated using the protocol.

18. A522 • Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant initiated; Tier 2 •  Decision time frame • 1st year – 18 mo • 2nd year – 15 mo • 3rd year and after – 12 mo • Fee - $10,000

19. A522 • An application that requires the review of a new public health efficacy protocol or a major change to an existing protocol. • Study design requires review by external members of AD Efficacy Protocol Review Expert Panel. • A draft label with proposed directions for use and marketing claims must accompany the application. • Protocol review and approval must be completed before an application for registration is submitted that includes efficacy data generated using the protocol

20. A531 • New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where the applicant does not own all required data and does not have a specific authorization letter from data owner

21. A531 • Decision Time Frame – 4 mo • Fee - $1500 • An application for registration of an end-use pesticide product that is substantially similar or identical in its uses and/or formulation to products that are currently registered or differ only in ways that would not significantly increase the risk of unreasonable adverse effects. A registered source of active ingredient must be used.

22. A531 • Chemistry, acute toxicity and/or efficacy data may be satisfied using the selective method of data citation. • However, similarity clinic, bridging or waiver requests will place the product into an A540 category. If efficacy and/or acute toxicity data are submitted to support this application then it will also be assigned to the A540 category.

23. A531 • In order to use the selective method to satisfy the chemistry data requirements, the proposed formulation must be identical to a currently registered product.

24. A532 • New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted • Decision time frame – 4 mo • Fee - $4200

25. A532 • An application for registration of an end-use pesticide product that is substantially similar or identical in its uses and/or formulation to products that are currently registered or differ only in ways that would not significantly increase the risk of unreasonable adverse effects. • All applications require submission of product chemistry data on the end-use product as well as the unregistered source.

26. A532 • Acute toxicity requirements must be addressed by using the cite-all method or cite-all selective method. However, similarity clinic, bridging or waiver requests will place the product into an A540 category. If efficacy and/or acute toxicity data are submitted to support this application then it will be assigned to the A540 category. • Additionally, to be included in this category, the cite-all method must be used to satisfy the generic data requirements. The applicant must identify the registered similar product.

27. A571 • Cancer reassessment; applicant initiated • An application in which a request is made to change the cancer classification • Decision time frame – 18 mo • Fee - $78,750

28. A572 • Refined ecological risk and/or endangered species assessment; applicant initiated • Decision time frame • 1st year – 18 mo • 2nd year – 18 mo • 3rd year and after - 12 mo • Fee - $75,000

29. A572 • An application is made which requests that the Agency refine its existing ecological risk or endangered species assessment based on new information or when an applicant has submitted their own assessment and requests that the Agency evaluate it.

30. Questions on the Action Codes???

31. How an Application is Processed

32. Coding the Mail • Incoming applications are divided among the regulatory divisions by the Front-End processing staff. • Once a day, the AD Expert Team assigns the appropriate PRIA code to incoming submissions. • Non-PRIA submissions are referred for FQPA coding.

33. Expert Teams • AD Expert Teams consist of 4 persons including both Product Managers and Staff. • Questions/comments concerning the application are noted on the review form. • Lack of clarity, or a non-existent cover page, can lead to a higher PRIA code being assigned.

34. Once Coded… • Once the PRIA code has been assigned/confirmed, the submission is returned to the Information Services Branch (ISB). • If data are associated with the submission, 86-5 review is conducted prior to data being forwarded to the regulatory division. • If 86-5 review is acceptable, data is sent to division for review.

35. Once Coded… • If 86-5 review is unacceptable, the registrant will have 21 days from the date the fee has been paid and the application submitted to correct the deficiencies or have the entire submission rejected. • A 21-day rejection will result in the Agency retaining 25% of the original PRIA fee.

36. Receipt by AD • Once the submission has been received by AD, the submission is given to the appropriate Product Manager (PM) Team for review. • Data is routed to the discipline for which it has been submitted. • The submission is given a more thorough review that includes completeness and deficiencies.

37. Completeness vs. Deficiencies • Any submissions that are incomplete will be given 21 days from the date the fee has been paid and the application submitted, for correction by the registrant. • Any submissions that are deficient will receive a 75-day letter from the PM Team.

38. AD PRIA Review (Tues/Thurs) • Every Tuesday and Thursday, PM Teams present their incoming PRIA submissions for discussion. • Issues concerning application coding, fees, completeness, deficiencies, and not grant letters are discussed.

39. Director’s Meeting (every Wednesday) • Every Wednesday, the AD Director meets with Branch Chiefs, Product Managers, and staff to review PRIA submissions. • Negotiation of time frames, 75-day letters, not grant letters, and overall processing issues are addressed. • Submissions requiring negotiations or not grant letters are submitted to the Deputy Office Director (DOD) for approval.

40. 21-Day Content Review

41. 21- Day Content Form • EPA File Symbol: ________ EPA Receipt Date: _________ • Fee Paid: Yes No • Experts In-Processing Signature: • EPA Reg. Number: EPA Receipt Date: • 1. Application Form (Form 8570-1) –signed & complete including package type? • 2. Confidential Statement of Formula (Form 8570-29) Is the CSF completely filled out (Boxes 1-21)? • 3. Certification with Respect to Citation of Data (Form 8570-34)? [Applicable, if submission is not a 100% repack]

42. 21- Day Content Form (cont’d) • 4. Formulator’s Exemption Statement (Form 8570-27)?If Formulator’s Exemption Statement was not addressed because registrant owns/formulates the source of active ingredient in product formulation, was a generic data matrix included? • 5. Data Matrix (Form 8570-35) [Applicable, if submission is not a 100% repack] a)Selective Method? If YES – then submission is not a Me-too.b) Cite-All Method? If YES – list only the companies offered to payc) Public copy of Matrix provided? See PR Notice 98-5 • 6. Is Label Included?

43. 21- Day Content Form (cont’d) • 7. If Data Required, has it been submitted? • 8. CRP Certification Statement (if applicable): • 9. 86-5 Rejection List?

44. In General… • No change from PRIA I process in regard to coding incoming mail • ITRMD forwards applications to PM • PM conducts the 21 day content screen using the checklist • Give 5 to 6 days for application review • AD Meets every Tuesday, Wednesday and Thursday to address any issues identified by the PM during their screen • Day 8 or 9, PM is expected to present any problems with the application during AD meeting • PM contacts the applicant at least twice to obtain missing information/data and documents each attempt. • If the Division recommends rejection, PM drafts rejection letter, attaches documentation of attempts to obtain the missing information and the package will be presented to DOD within the 21 days for signature.

45. Questions on How an Application is Processed???

46. The “Old” Stuff… • 75 Day Letters • Negotiations • Not Grant Letters

47. 75 Day Letters When a deficiency is identified, AD will provide notice to the registrant that they have 75 days to address the deficiency. If the “fix” is not received by day 75 or the date scheduled, the Agency will administratively withdraw the submission.

48. 75 Day Letters (cont’d) • 40 CFR Part 152.105 states: The Agency will not begin or continue the review of an application that is incomplete. If the Agency determines that an application is incomplete or that further information is needed in order to complete the Agency's review, the Agency will notify the applicant of the deficiencies and allow the applicant 75 days to make corrections or additions to complete the application. If the applicant believes that the deficiencies cannot be corrected within 75 days, he must notify the Agency within those 75 days of the date on which he expects to complete the application. If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the application within the time scheduled for completion, the Agency will terminate any action on such application, and will treat the application as if it had been withdrawn by the applicant. Any subsequent submission relating to the same product must be submitted as a new application.

49. 75 Day Letters (cont’d) • If you receive a deficiency notice that has the 75-day language in it, you are urged to contact the PM Team as soon as possible to resolve the deficiency and request a negotiated due date if needed. • OPP has withdrawn applications that have failed to respond to these letters.

50. Negotiations • If the Agency discovers that a deficiency may compromise the regulatory clock, the registrant is notified. • The negotiation request is sent to the reviewer who then completes the “Renegotiation Form” and submits to the Branch Chief. • The Branch Chief then discusses the negotiation request with AD Management. • Once reviewed, the negotiation request is sent to the OD or DOD for acceptance.