mm s r4 US Environmental Protection Agency Office of Pesticide Programs Table III Number of PRIA Applications Pending at the End of Fiscal Year (FY 2005 through FY 2008) February 2009 ------- Table III Number of PRIA Applications Pending at the End of Fiscal Year (FY 2005 through FY 2008) Key to the table • R - Conventional Pesticides • A - Antimicrobial Pesticides • B - Biopesticides • EUP - Experimental Use Permit • PIP - Plant-Incorporated Protectants • SAP - FIFRA Scientific Advisory Panel • SCLP - Straight Chain Lepidopteran Pheromones Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 R01 New Active Ingredient, Food Use 27 54 48 24 R010 New Active Ingredient, Food Use 14 R02 New Active Ingredient, Food Use, Reduced Risk 10 22 18 6 R03 New Active Ingredient, Food Use, Experimental Use Permit (EUP) submitted simultaneously with application for registration 0 1 0 R04 New Active Ingredient, Food Use, EUP with temporary tolerance, submitted before application for registration 0 2 0 R05 New Active Ingredient, Food use submitted after an EUP 0 0 17 1 R06 New Active Ingredient, Non-food use, outdoor 10 10 6 5 R060 New Active Ingredient, Non-food use, outdoor 11 R07 New Active Ingredient, Non-food use, outdoor, reduced risk 1 0 1 R08 New Active Ingredient, Non-food use, outdoor, EUP request submitted simultaneously with application for registration 0 2 0 R09 New Active Ingredient, Non-food use, outdoor, EUP submitted before application for registration 0 1 2 RIO New Active Ingredient, Non-food use, outdoor, submitted after EUP 0 0 3 3 Rll New Active Ingredient, Non-food use, indoor 4 6 2 R120 New Active Ingredient, Non-food use; indoor; reduced risk 2 R123 New Active Ingredient, Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities 2 R124 Conditional Ruling on Preapplication Study Waivers; applicant- initiated 11 R13 New Use, First food use, indoor food/food handling 0 0 2 2 ------- Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 R14 New Use, Additional food use, indoor Food/Food handling 3 6 5 3 R15 New Use, First Food Use 2 9 18 11 R16 New Use, First Food Use, Reduced Risk 0 0 3 3 R17 New Use, Each Additional New Food Use 214 278 255 67 R170 New Use, Additional Food Use 112 R18 New Use, Each Additional New Food Use, Reduced Risk 39 11 11 2 R180 New Use, Additional food use; reduced risk 13 R19 New Use, Additional New Food Uses, Bundled, 6 or more 64 81 93 31 R190 New Use, Additional food uses; 6 or more submitted in one application 34 R20 New Use, Additional New Food Uses, Bundled, 6 or more, Reduced Risk 6 4 4 R200 New Use, Additional food uses; 6 or more submitted in one application; reduced risk 11 R21 New food use, With EUP and temporary tolerance 0 1 2 1 R210 New Use, Additional food use; EUP; establish temporary tolerance; no credit toward new use registration 2 R220 New Use, Additional food use; EUP; crop destruct basis; no credit toward new use registration 2 R23 New use, Non-food, outdoor 44 43 24 7 R230 New Use, Additional use; non-food; outdoor 25 R24 New Use, Non-food, outdoor, Reduced Risk 1 7 6 R240 New Use, Additional use; non-food; outdoor; reduced risk 4 R25 New use, Non-food, outdoor with EUP (no credit toward new use registration) 3 0 1 R250 New Use, Additional use; non-food; outdoor; EUP; no credit toward new use registration 1 R26 New Use, Non-food, indoor 17 15 4 1 R260 New use; non-food; indoor 3 R272 Review of Study Protocol; applicant-initiated; excludes DART, pre- registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review 7 R274 New Uses, Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses 3 ------- Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 R28 Import tolerance, New Active Ingredient or first food use 12 4 1 1 R280 Establish import tolerance; new active ingredient or first food use 2 R29 Import tolerance, Additional new food use 9 10 9 5 R290 Establish import tolerance; additional food use 2 R292 Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated 22 R293 Establish tolerance(s) for inadvertent residues in one crop; applicant- initiated 3 R295 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 1 R30 New Product, Me-Too, Fast Track 45 62 85 R300 New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. 51 R301 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 applicant does not own all required data and does not have a specific authorization letter from data owner. 13 R31 New Product, Non-Fast Track (includes review of product chemistry, acute toxicity, public health pest efficacy) 221 204 189 4 R310 New end-use or manufacturing-use product; requires review of data package within RD; includes reviews and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy 141 R313 New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated 6 R32 New Product, Non Fast Track, new physical form (excludes selective citations) 17 11 17 5 R320 New product; new physical form; requires data review in science divisions 9 R33 New manufacturing-use product, Old Active Ingredient, Selective Citation 25 21 21 1 ------- Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 R330 New manufacturing-use product; registered active ingredient; selective data citation 3 R34 Amendment, Non-fast Track (includes changes to precautionary label statements, source changes to an unregistered source) 57 68 58 1 R340 Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient) 63 R35 Amendment, Non-fast track (changes to REI, PPE, PHI, rate and number of applications, add aerial application, modify GW/SW advisory statement) 85 55 48 2 R350 Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement) 63 R36 Non-fast track, Isomers 2 0 0 R37 Cancer Reassessment, applicant initiated 6 5 6 1 A38 New Active Ingredient, Food use, with exemption 1 0 0 A380 New Active Ingredient, Food use; establish tolerance exemption 1 A41 New Active Ingredient, Non-food use, outdoor, other uses 12 9 5 2 A42 New Active Ingredient, Non-food use, indoor, FIFRA sec. 2(mm) uses 14 5 5 3 A44 New Use, First food use, with exemption 0 3 5 2 A440 New Use, First food use; establish tolerance exemption 2 A46 New Food Use, with exemption 6 6 4 1 A460 New Food Use, Additional food use; establish tolerance exemption 3 A47 New Food use, with tolerance 1 0 0 A470 New Food use, Additional food use; establish tolerance 1 A48 New use, Non-food, outdoor FIFRA sec. 2(mm) uses 1 0 4 A480 New use, Additional use; non-food; outdoor; FIFRA §2(mm) uses 2 A49 New use, Non-Food, outdoor, other uses 0 3 2 1 A490 New use, Additional use; non-food; outdoor; uses other than FIFRA §2(mm) 3 A50 New use, Non-Food, indoor FIFRA sec. 2(mm) uses 5 15 10 1 A500 New use, Additional use; non-food; indoor; FIFRA §2(mm) uses 27 A51 New use, Non-Food, indoor, other uses 3 3 0 A52 Experimental Use Permit 1 0 0 A520 Experimental Use Permit application 1 ------- Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 A521 Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 2 A522 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant- initiated; Tier 2 3 A53 New Product, Me-too, Fast Track 24 23 22 A530 New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. 15 531 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 applicant does not own all required data and does not have a specific authorization letter from data owner. 5 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 6 A54 New Product, Non-Fast Track, FIFRA sec. 2 (mm) uses 28 36 41 4 A540 New end use product; FIFRA §2(mm) uses only 32 A55 New Product, Non-Fast Track, other uses 10 7 4 1 A550 New end-use product; uses other than FIFRA §2(mm); non-FQPA product 1 A56 New Manufacturing use product, old active ingredient, selective citation 7 6 5 A560 New manufacturing-use product; registered active ingredient; selective data citation 4 A57 Amendments, Non-Fast Track 42 56 50 1 A570 Label amendment requiring data submission 55 B59 New Active Ingredient, Food Use, Microbial/Biochemical, with exemption 17 13 11 12 B590 New active ingredient; food use; establish tolerance exemption, Mi crobi al/Bi ochemi cal, 19 ------- Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 B60 New Active Ingredient, Non-food use, Microbial/Biochemical 11 13 14 10 B600 New active ingredient; non-food use, Microbial/Biochemical, 9 B61 EUP, Food Use with temporary tolerance exemption, Microbial/Biochemical 2 2 2 B610 Food use; EUP; establish temporary tolerance exemption, Mi crobi al/Bi ochemi cal, 2 B62 EUP, Non-food use, Microbial/Biochemical 0 1 0 B63 New Use, First Food Use, Microbial/Biochemical, with exemption 10 2 11 7 B630 First food use; establish tolerance exemption, Microbial/Biochemical, 1 B631 Amend established tolerance exemption, Microbial/Biochemical 4 B65 New Use, Non-Food, Microbial/Biochemical 0 3 0 B66 New Product, Me-Too, Fast Track, Microbial/biochemical 0 2 4 B660 New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. Microbial/biochemical 2 B67 New Product, Non-Fast Track, Microbial/Biochemical 30 29 27 1 B670 New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product specific data or with request for data waivers supported by scientific rationales, Microbial/Biochemical 5 B671 New product; food use; unregistered source of active ingredient; requires amendment of established tolerance or tolerance exemption; all Tier I data requirements for product chemistry, toxicology, non- target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales, Microbial/Biochemical 6 B672 New product; non-food use or food use having established tolerance or tolerance exemption; unregistered source of active ingredient; no data compensation issues; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales, Microbial/Biochemical 13 B68 Amendment, Non-Fast Track, Microbial/Biochemical 8 13 6 ------- Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 B680 Label amendment requiring data submission, Microbial/Biochemical 6 B681 Label amendment; unregistered source of active ingredient; supporting data require scientific review 2 B69 Straight Chain Lepidopteran Pheromones (SCLP), New Active Ingredient, Food Use or non-Food Use 0 1 0 B690 SCLP, New active ingredient; food or non-food use 2 B70 SCLP, EUP, New Active Ingredient or New Use 0 0 0 B71 SCLP, New Product, Me-Too, Fast Track 0 2 0 B710 SCLP, New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. 2 B72 SCLP, New Product Non-Fast Track 3 3 2 B720 SCLP, New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product specific data or with request for data waivers supported by scientific rationales 1 B73 SCLP, Amendment, Non-Fast Track 0 0 0 B740 Plant-Incorporated Protectants (PIP), EUP; registered active ingredient; non-food/feed or crop destruct basis; no Scientific Advisory Panel (SAP) review required 1 B761 PIP, EUP; new active ingredient; non-food/feed or crop destruct; no SAP review required; credit $78,750 toward new active ingredient application that follows B75 PIP, EUP, with Temporary Tolerance or Exemption, No SAP 2 2 0 B77 PIP, EUP, New Active Ingredient, Set Temporary Tolerance or Exemption, SAP 1 0 1 B80 PIP, Register New Active Ingredient, Temporary Tolerance or Exemption Exists, No SAP 2 0 1 B81 PIP, Register New Active Ingredient, Temporary Tolerance or Exemption Exists, SAP 2 3 7 3 B84 PIP, Register New Active Ingredient, Set Tolerance or Exemption, SAP 1 0 2 2 B86 PIP, EUP, Food Use, Amendment 2 0 3 B88 PIP, New Product 5 0 0 ------- Progress in Meeting Decision Times - Number of PRIA Actions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2005 2006 2007 2008 B880 PIP, New product; no SAP review required 2 B881 PIP, New product; SAP review required 1 B90 PIP, Amendment, Non-Fast Track 3 2 0 B900 PIP, Amendment (except #B890); No SAP review required; (e.g., new IRM requirements that are applicant initiated; or amending a conditional registration to extend the registration expiration date with additional data submitted) (2) 13 B901 PIP, Amendment (except #B890); SAP review required 1 ------- |