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PRIA 2 Workshop Webcast Questions and Answers -- December 2007

  1. Is anyone paying attention to these questions?
  2. If deadline for withdrawal is 60 days to obtain maximum refund ...
  3. What are 86-5 issues?
  4. Beginning of decision review period, ... is it possible for the clock to start less than 21 days after receipt of fee payment and application?
  5. Will the contractor be the applicants contact for 21 day review concerns?
  6. Under the long term procedure will the applicant be able to respond to incomplete content review?
  7. How do the 4 lists of inert pesticide ingredients relate to the new lists of approved inert ingredients ...?

The following are a series of questions asked by e-mail during the November 27, 2007 PRIA 2 webcast. The Agency apologizes that because of audio difficulties you were not able to ask your question during the workshop. Answers to your questions are below.

  1. Is anyone paying attention to these questions?
  2. Due to nature of the webcast, your questions are being addressed in this format after the workshop. The Agency apologizes for the technical difficulties experienced by webcast participants. This was the Office of Pesticide Programs initial attempt to use this specific technology.
  3. If deadline for withdrawal is 60 days to obtain maximum refund, and EPA minimum timeline for review/response is 90 days -- how is registrant assured of knowing when the Agency may require additional registration support that would precipitate a withdrawal?
  4. There is no minimum timeline for an EPA review or response to an application. A refund for an early withdrawal defined as within the first 60 days of the decision time review period is 75% of the fee. The amount of the refund for an application withdrawn after the first 60 days is dependent upon the amount of EPA work remaining on the application. The EPA has 90 days to make a determination on the amount of this refund and its maximum is also 75%.
  5. What are 86-5 issues?
  6. The Agency has published standards for formatting data submissions in the document Pesticide Registration Notice 86-5: Standard Format for Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) available on the internet, http://www.epa.gov/PR_Notices/pr86-5.html. 86-5 issues arise when this guidance is not followed.
  7. Beginning of decision review period, assuming no problems with completeness, is it possible for the clock to start less than 21 days after receipt of fee payment and application?
  8. The Pesticide Registration Improvement Renewal Act is specific regarding when the timeframe or "clock" begins. Under Section 33(f)(4), "Start of decision time review period, (A), In general,

    "Except as provided in subparagraphs (C), (D), and (E), in the case of a pesticide registration application accompanied by the registration service fee required under this section, the decision time review period begins 21 days after the date on which the Administrator receives the covered pesticide registration application."

    Subparagraphs (C), (D), and (E) address fee waivers, fee reductions, pending applications, and the Registration Division's 2003 workplan. In the case of a request for a fee waiver or a fee reduction under (C), provided the appropriate portion of the fee has been paid, the "clock" begins when the waiver is granted. If monies are still owed or the waiver is denied, the "clock" begins when payment is received. For applications pending with the Agency prior to March 23, 2004 and for which the applicant would like to pay a voluntary fee to obtain a PRIA timeframe covered by (D), the "clock" begins on the date that certification of payment of the applicable registration service fee is received. Subparagraph (E) covers actions in the Registration Division's 2003 workplan and these applications already have a PRIA timeframe under PRIA 1.

    The PRIA decision review timeframe could start in less than 21 days if a fee waiver is granted in less than 21 days and the appropriate portion of the fee had been received by the Agency before the waiver was granted.

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  9. Will the contractor be the applicants contact for 21 day review concerns?
  10. The contact for any 21 day review concerns will be an Agency employee and the individual(s) will be identified when the contractor informs an applicant of any 21 day review concerns.
  11. Under the long term procedure will the applicant be able to respond to incomplete content review?
  12. Yes, applicants will be able to and should respond to the results of the 21 day content review within the 21 day period that begins when the Agency has received both the appropriate registration service fee and the application. If the applicant is exempted from paying registration service fees, the 21 day content review begins when the Agency grants the exemption.
  13. How do the 4 lists of inert pesticide ingredients relate to the new lists of approved inert ingredients or what are the differences between the 4 lists of inerts that are out now and the list of cleared inerts that are to come out?
  14. The 1 through 4 lists of inerts are no longer valid lists for pesticide products regulated by OPP. The old list 4 is currently being used by USDA for their organic program. As soon as USDA updates their website OPP will remove all the 4 outdated lists. The "1-4 lists" categorized inerts ingredients according to whether there were toxicological concerns, potential concerns, unknown toxicities, minimal risks or no adverse affects to public health and the environment. In August 2006, OPP completed tolerance reassessment for the food use inert ingredients, only inerts ingredients that met FQPA safety requirements were reassessed and not revoked; and this is the reason the 1-4 lists are no longer valid for OPP.

    The new inerts list (expected to be available late December 2007/early January 2008) will contain all non food use inert ingredients used in pesticide products. The list of approved food use inert ingredients are already on the website of the Code of Federal Regulations (E-CFR). This is the same website where all other pesticide tolerances are listed in real time. Inert ingredients are found in title 40, part 150-180, sections 180.910 - 960 (with a few in later sections)

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