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The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3)

The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3). Inert Ingredients and PRIA 3 Presented at: PRIA 3 Workshop April 10, 2013 By Kerry Leifer Inert Ingredient Assessment Branch Registration Division. New Categories of Inert Ingredient Actions Under PRIA 3.

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The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3)

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  1. The Pesticide Registration Improvement Extension Act of 2012 (PRIA 3) Inert Ingredients and PRIA 3 Presented at: PRIA 3 Workshop April 10, 2013 By Kerry Leifer Inert Ingredient Assessment Branch Registration Division

  2. New Categories of Inert Ingredient Actions Under PRIA 3 PRIA 3 now includes 10 fee categories related to inert ingredient submissions: • I001 -- Approval of new food use inert ingredient • I002 -- Amend currently approved inert ingredient tolerance or exemption from tolerance; new data • I003 -- Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data • I004 -- Approval of new non-food use inert ingredient • I005 -- Amend currently approved non-food use inert ingredient with new use pattern; new data

  3. New Categories of Inert Ingredient Actions Under PRIA 3 (cont.) • I006 -- Amend currently approved non-food use inert ingredient with new use pattern; no new data • I007 -- Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern • I008 -- Approval of new polymer inert ingredient, food use • I009 -- Approval of new polymer inert ingredient, non food use • I010 -- Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data

  4. Inert Ingredients and PRIA 3

  5. Inert Ingredient PRIA 3 Submissions • Sixteen inert ingredient PRIA 3 actions received by the Agency to date • All inert ingredient PRIA 3 actions subject to initial content screen have been deemed complete • 45/90 day technical deficiency screen has been conducted on ten actions—no deficiency letters issued to date

  6. PRIA 3 Inert Submissions by Category

  7. Early “Trends” with PRIA 3 Inert Ingredient Submissions • To date no PRIA 3 submissions have been received by the Agency for any of the nonfood use inert ingredient categories (I-004, I-005, I-006, I-009) • Six of the 16 submissions were submitted with the incorrect category • Many of the incorrect category submissions involved food use requests submitted under nonfood use categories (e.g., new food use inert ingredient submitted under I-006 category)

  8. Evaluation of Inert Ingredient PRIA 3 Submissions • IIAB has developed new guidance documents to assist submitters in preparing and submitting applications • These documents can be found at http://www.epa.gov/opprd001/inerts/ • Other valuable resources: • “Inert Ingredient Frequently Asked Questions” http://www.epa.gov/opprd001/inerts/faqs.pdf • Inert Ingredient Assessment Branch email box: InertsBranch@epa.gov

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