Implementing the Pesticide Registration Improvement Act - Fiscal Year 2013 Tenth Annual Report March 1, 2014 ------- Table IV Number of PRIA Decisions Pending at the End of Fiscal Year (FY 2010 through FY 2013) 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 Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 R01 New Active Ingredient, Food Use 1 1 1 1 R010 New Active Ingredient, Food Use 78 74 30 38 R020 New Active Ingredient, Food use; reduced risk 4 24 17 20 R040 Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit $326,025 toward new active ingredient application that follows 2 1 R060 New Active Ingredient, Non-food use, outdoor 2 9 R090 New Active Ingredient, Non-food use, outdoor, EUP 1 R110 New Active Ingredient, Non-food use; indoor 3 7 5 3 R123 New Active Ingredient, Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities 2 4 2 R124 Conditional Ruling on Pre-application Study Waivers; applicant- initiated 2 4 2 R125 New Active Ingredient, Seed Treatment; EUP 1 R13 New Use, First food use, indoor food/food handling 2 2 R140 Additional food use; Indoor; food/food handling 6 10 6 7 R15 New Use, First Food Use 2 R150 New Use, First food use 11 25 14 14 R17 New Use, Each Additional New Food Use 11 7 5 5 R170 New Use, Additional Food Use 131 179 209 159 R175 Additional food uses covered within a crop grouping resulting from the conversion of an existing approved crop grouping 15 1 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 R180 New Use, Additional food use; reduced risk 13 7 28 22 R19 New Use, Additional New Food Uses, Bundled, 6 or more 3 3 R190 New Use, Additional food uses; 6 or more submitted in one application 58 75 62 52 R200 New Use, Additional food uses; 6 or more submitted in one application; reduced risk 9 14 21 4 R210 New Use, Additional food use; EUP; establish temporary tolerance; no credit toward new use registration 2 3 2 R220 New Use, Additional food use; EUP; crop destruct basis; no credit toward new use registration 2 2 R23 New use, Non-food, outdoor 1 1 1 1 R230 New Use, Additional use; non-food; outdoor 25 22 20 17 R240 New Use, Additional use; non-food; outdoor; reduced risk 2 R251 EUP which requires no changes to tolerance; non-crop destruct 1 R260 New use; non-food; indoor 7 6 7 8 R270 New use; non-food; indoor; reduced risk 1 1 R272 Review of Study Protocol; applicant-initiated; excludes DART, pre- registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review 3 5 9 3 R273 Additional use; seed treatment; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses 11 6 3 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 5 R280 Establish import tolerance; new active ingredient or first food use 5 5 4 4 R29 Import tolerance, Additional new food use 3 1 1 1 R290 Establish import tolerance; additional food use 5 7 13 12 B291 Establish import tolerances; additional food uses; 6 or more crops submitted in one petition 1 1 R292 Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated 12 22 22 16 R293 Establish tolerance(s) for inadvertent residues in one crop; applicant- 2 1 2 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 initiated R295 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 5 5 5 5 R296 Establish tolerances for residues in rotational crops in response to specific petition; 6 or more crops submitted in one application 1 R298 Amend established tolerance, submission of amended labels 18 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. 60 64 54 40 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. 11 11 31 12 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 140 122 118 70 R311 New product; requires approval of new food-use inert; applicant- initiated; excludes approval of safeners 3 2 1 R312 New product; requires approval of new non-food use inert, applicant initiated. 2 R313 New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated 2 R314 New product with 2 or more registered AIs never before registered as this combination 18 R315 New product, non-food, animal product with 2 animal safety studies 7 R32 New Product, Non Fast Track, new physical form (excludes selective citations) R320 New product; new physical form; requires data review in science divisions 25 18 15 15 R330 New manufacturing-use product; registered active ingredient; 6 8 15 3 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 selective data citation R333 New product with unregistered source of AI, cite-all 29 R334 New product with unregistered source of AI, selective citation 10 R340 Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient) 66 82 56 57 R35 Amendment, Non-fast track (changes to REI, PPE, PHI, rate and number of applications, add aerial application, modify GW/SW advisory statement) 2 2 2 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) 55 45 57 44 R351 Amendment adding new unregistered source of AI 33 R352 Amendment adding already approved uses, 2 R370 Cancer reassessment; applicant-initiated 3 1 2 2 R371 Amendment to EUP 1 A380 New Active Ingredient, Food use; establish tolerance exemption 1 1 A400 New Active Ingredient, Non-food use; outdoor; FIFRA section (2mm) uses 1 1 1 A41 New Active Ingredient, Non-food use, outdoor, other uses 2 2 A42 New Active Ingredient, Non-food use, indoor, FIFRA sec. 2(mm) uses 1 1 A420 Non-food use; indoor; FIFRA section 2(mm) uses 7 10 8 6 A440 New Use, First food use; establish tolerance exemption 2 2 4 2 A460 New Food Use, Additional food use; establish tolerance exemption 6 6 6 6 A470 Additional food use, establish tolerance 1 A480 New use, Additional use; non-food; outdoor; FIFRA §2(mm) uses 2 1 3 2 A490 New use, Additional use; non-food; outdoor; uses other than FIFRA §2(mm) 1 2 3 2 A500 New use, Additional use; non-food; indoor; FIFRA §2(mm) uses 6 8 9 8 A510 Additional use; non-food; indoor; uses other than FIFRA section 2(mm) 1 3 A520 Experimental Use Permit application 2 1 A521 Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; 3 4 10 6 4 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 applicant-initiated; Tier 1 A522 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant- initiated; Tier 2 3 4 2 4 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. 21 24 28 9 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 applicant does not own all required data and does not have a specific authorization letter from data owner. 14 8 10 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 3 12 11 9 A540 New end use product; FIFRA §2(mm) uses only 41 48 45 35 A550 New end-use product; uses other than FIFRA §2(mm); non-FQPA product 3 6 7 A560 New manufacturing-use product; registered active ingredient; selective data citation 6 7 7 1 A570 Label amendment requiring data submission 75 44 30 35 A572 New product or amendment requiring data review 1 B590 New active ingredient; food use; establish tolerance exemption, Microbial/Biochemical, 63 60 40 44 B600 New active ingredient; non-food use, Microbial/Biochemical, 12 17 14 7 B610 Food use; EUP; establish temporary tolerance exemption, Microbial/Biochemical 2 B620 Non-food use; Experimental Use Permit application, Microbial/Biochemical 1 1 1 B621 Extend or amend Experimental Use Permit, Microbial/Biochemical 1 1 B63 New Use, First Food Use, Microbial/Biochemical, with exemption 3 5 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 B630 First food use; establish tolerance exemption, Microbial/Biochemical, 11 2 5 12 B631 Amend established tolerance exemption, Microbial/Biochemical 2 6 4 B641 Amend established tolerance (e.g., decrease or increase) 1 B644 New use, no change to existing tolerance or tolerance exemption 1 B650 New use; Non-Food, Microbial/Biochemical 3 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 8 3 7 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 11 9 12 23 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 3 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 10 18 12 12 B673 New product, unregistered source of AI; citation of TGAI previously approved 5 B680 Label amendment requiring data submission, Microbial/Biochemical 4 2 6 2 B681 Label amendment; unregistered source of active ingredient; supporting data require scientific review, Microbial/Biochemical 2 4 1 4 B682 Protocol review; applicant-initiated; excludes time for HSRB review (pre application), Microbial/Biochemical 1 B690 SCLP, New active ingredient; food or non-food use 1 1 6 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 B700 EUP, new AI or new use 1 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. 1 1 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 2 1 1 B721 SCLP, New product; unregistered source of active ingredient 2 1 1 B730 SCLP, Label amendment requiring data submission 2 B740 Plant-Incorporated Protectants (PIP), EUP; registered active ingredient; non-food/feed or crop destruct basis; no Scientific Advisory Panel (SAP) review required 2 B771 PIP, Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required; 2 1 B773 PIP, Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption 2 B800 PIP, New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required 4 8 B820 PIP, New active ingredient, establish tolerance or exemption; no SAP 2 2 B851 PIP, New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; no SAP review required 1 B870 PIP, New use 1 B880 PIP, New product; no SAP review required 2 3 3 6 B881 PIP, New product; SAP review required 5 3 B885 PIP, seed increase, breeding stack of previously approved PIPs, same crop 1 B890 Amendment to seed increase registration; converts to commercial registration 2 7 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year PRIA Category Description of Category Number of PRIA Decisions Pending at the End of Fiscal Year 2010 2011 2012 2013 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) 5 3 B902 PIP protocol review 1 B903 Inert ingredient tolerance exemption, e.g., a marker such as NPT II 1 1001 New food-use inert 10 1002 Amend existing inert tolerance or exemption, new data 2 1003 Amend existing inert tolerance or exemption, no new data 2 1004 New non-food use inert 1 1006 Amend existing non-food use inert with new use pattern, no new data 1 1007 Substantially similar non-food use inert 1 1008 New polymer inert, food use 3 1009 New polymer inert, non-food use 1 1010 Amend a tolerance exemption descriptor to add CASRNs, no new data 1 M005 New product, combination of AIs from AD, BPPD, RD 2 M006 Gold seal letters 10 M007 Extension of Exclusive use of data 3©(l)(F)(ii) 3 8 ------- |