Implementing the Pesticide Registration Improvement Act - Fiscal Year 2018 Fifteenth Annual Report ------- Table IV Number of PRIA Decisions Pending at the End of the Fiscal Year (FY 2015 through FY 2018) Key to the table • R - Conventional Pesticides • A - Antimicrobial Pesticides • B - Biopesticides • EUP - Experimental Use Permit • I - Inert Ingredient • M - Miscellaneous • 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 2015 2016 2017 2018 R010 New Active Ingredient, Food Use 20 27 36 65 R020 New Active Ingredient, Food use; reduced risk 26 20 20 6 R060 New Active Ingredient, Non-food use, outdoor 6 10 10 R090 New Active Ingredient, Non-food use, outdoor, EUP 1 1 R110 New Active Ingredient, Non-food use; indoor 3 2 2 2 R121 New Active Ingredient, Non-food use; indoor; EUP 1 R124 Conditional Ruling on Pre-application Study Waivers; applicant- initiated 2 5 5 3 R140 Additional food use; Indoor; food/food handling 2 3 R150 New Use, First food use 10 6 3 6 R17 New Use, Each Additional New Food Use 5 5 5 5 R170 New Use, Additional Food Use 202 190 198 192 R175 Additional food uses covered within a crop grouping resulting from the conversion of an existing approved crop grouping 76 56 85 101 R180 New Use, Additional food use; reduced risk 16 33 23 30 R190 New Use, Additional food uses; 6 or more submitted in one application 73 50 49 57 R200 New Use, Additional food uses; 6 or more submitted in one application; reduced risk 10 12 15 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 2015 2016 2017 2018 R230 New Use, Additional use; non-food; outdoor 19 13 17 18 R240 New Use, Additional use; non-food; outdoor; reduced risk 3 4 2 R250 EUP, new use; no credit toward new use registration 1 R251 EUP which requires no changes to tolerance; non-crop destruct 1 R260 New use; non-food; indoor 8 2 5 6 R270 New use; non-food; indoor; reduced risk 2 1 2 R271 New use; non-food; indoor; EUP 1 R272 Review of Study Protocol; applicant-initiated; excludes DART, pre- registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review 3 4 7 7 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 12 7 4 1 R280 Establish import tolerance; new active ingredient or first food use 2 3 5 3 R29 Import tolerance, Additional new food use 1 1 1 1 R290 Establish import tolerance; additional food use 7 18 14 21 B291 Establish import tolerances; additional food uses; 6 or more crops submitted in one petition 2 2 R292 Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated 18 9 10 11 R294 Establish tolerances for inadvertent residues; 6 or more 1 1 1 1 R295 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 1 1 7 R298 Amend established tolerance, submission of amended labels 28 22 21 7 R299 Amend 6 or more established tolerances; submission of amended labels. 11 11 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 2015 2016 2017 2018 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, 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. 47 32 76 45 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. 27 30 42 29 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 46 52 67 44 R314 New product with 2 or more registered AIs never before registered as this combination 30 17 38 22 R315 New product, non-food, animal product with 2 animal safety studies 9 13 2 8 R320 New product; new physical form; requires data review in science divisions 25 18 17 18 R331 New product, repack of identical end-use product as a MUP 2 R333 New product with unregistered source of AI, cite-all 29 21 37 20 R334 New product with unregistered source of AI, selective citation 22 48 43 35 R340 Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient) 38 28 49 35 R345 Amendment; non-food animal product with animal safety data 1 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) 50 31 39 54 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 2015 2016 2017 2018 R351 Amendment adding new unregistered source of AI 51 47 65 76 R352 Amendment adding already approved uses, 5 2 3 2 R370 Cancer reassessment; applicant-initiated 1 4 5 2 A380 New a.i., food use, establish tolerance exemption 2 A420 New a.i., non-food use; indoor; FIFRA section 2(mm) uses 17 5 2 4 A440 New use, First food use; establish tolerance exemption 4 1 1 A460 New use, Additional food use; establish tolerance exemption 5 5 3 3 A470 New use, Additional food use; establish tolerance 2 A480 New use, Additional use; non-food; outdoor; FIFRA §2(mm) uses 2 A490 New use, Additional use; non-food; outdoor; uses other than FIFRA §2(mm) 1 A500 New use, Additional use; non-food; indoor; FIFRA §2(mm) uses 2 2 9 A510 Additional use; non-food; indoor; uses other than FIFRA section 2(mm) 4 A521 Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 1 3 4 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 3 A523 Review of protocol other than public health efficacy study 1 1 A530 New product; identical or substantially similar in composition anduse 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. 11 10 9 10 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. 11 4 7 2 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 5 5 1 5 A540 New end use product; FIFRA §2(mm) uses only 41 47 41 45 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 2015 2016 2017 2018 A550 New end-use product; uses other than FIFRA §2(mm); non-FQPA product 1 3 3 3 A560 New manufacturing-use product; registered active ingredient; selective data citation 16 9 9 3 A570 Label amendment requiring data submission 62 54 82 48 A571 Science reassessment: cancer; eco; ESA 1 1 1 A572 New product or amendment requiring data review 3 2 1 2 B590 New active ingredient; food use; establish tolerance exemption, Mi crobi al/B i ochemi cal, 29 46 136 49 B600 New active ingredient; non-food use, Microbial/Biochemical, 5 4 6 12 B610 Food use; EUP; establish temporary tolerance exemption, Mi crobi al/B i ochemi cal 2 2 B612 New active ingredient; no change to permanent tolerance exemption. 10 1 1 B614 Conditional ruling pre-application study waiver 1 1 1 3 B620 Non-food use; Experimental Use Permit application, Mi crobi al/B i ochemi cal 1 1 B621 Extend or amend Experimental Use Permit, Microbial/Biochemical 2 1 B630 First food use; establish tolerance exemption, Microbial/Biochemical, 9 2 13 B640 New food use; petition to amend an established tolerance 4 4 B641 Amend established tolerance (e.g., decrease or increase) 1 B643 New food use; petition to amend tolerance exemption 5 4 B644 New use, no change to existing tolerance or tolerance exemption 1 1 8 B650 New use; non-food 4 1 B660 New product; identical or substantially similar in composition anduse 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 3 6 4 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, Mi crobi al/B i ochemi cal 9 15 13 16 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 2015 2016 2017 2018 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 2 2 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, Mi crobi al/B i ochemi cal 8 6 12 13 B673 New product, unregistered source of AI; citation of TGAI previously approved 7 2 5 13 B674 New product; MUP; repack of identical end-use product as MUP 1 B676 New product, more than 1 active ingredient where one is an unregistered source 1 B680 Label amendment requiring data submission, Microbial/Biochemical 6 8 8 3 B681 Label amendment; unregistered source of active ingredient; supporting data require scientific review, Microbial/Biochemical 3 12 4 8 B682 Protocol review; applicant-initiated; excludes time for HSRB review 1 B683 Label amendment; update of previous risk assessment; no new data 1 2 1 B690 SCLP, New active ingredient; food or non-food use 4 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 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 5 2 1 B721 SCLP, New product; unregistered source of active ingredient 2 3 4 B730 SCLP, Label amendment requiring data submission 1 7 ------- Progress in Meeting Decision Times - Number of PRIA Decisions Pending at End of Fiscal Year Number of PRIA Decisions PRIA Category Description of Category Pending at the End of Fiscal Year 2015 2016 2017 2018 B771 PIP, Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required; 2 2 B772 Amend or extend EUP 1 1 B773 Amend or extend EUP with temporary tol exemption extension 2 B780 New PIP; non-food/feed 1 B790 New PIP; non-food/feed; SAP review 1 B800 New PIP; establish tol or exemption based on temporary tol 4 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 B880 PIP, New product; no SAP review required 2 7 2 1 B881 New PIP product; new terms of registration; additional data; SAP review 2 B883 New PIP, seed increase with negotiated acreage cap and time-limited registration with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption 2 B885 PIP, seed increase, breeding stack of previously approved PIPs, same crop 2 9 1 3 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) 1 1 10 B903 Inert tolerance exemption, reviewed in BPPD 1 B904 Import tolerance or tolerance exemption; processed commodities/ food use only (inert or active ingredient) 1 1001 New food-use inert 26 18 18 28 1002 Amend existing inert tolerance or exemption, new data 2 5 2 1 1003 Amend existing inert tolerance or exemption, no new data 1 1 4 5 1004 New non-food use inert 3 6 4 2 8 ------- 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 2015 2016 2017 2018 1005 Amend currently approved non-food use inert with new use pattern, no new data 1 1006 Amend existing non-food use inert with new use pattern, no new data 1 1008 New polymer inert, food use 8 4 4 6 1009 New polymer inert, non-food use 3 1 4 5 M001 Protocol review by HSRB 1 2 4 1 M002 Completed study requiring HSRB review 1 M005 New product, combination of AIs from AD, BPPD, RD 3 2 1 M006 Gold seal letters 36 160 M007 Extension of Exclusive use of data 3(c)(l)(F)(ii) 2 1 4 3 M008 Exclusive use of data for a minor use 3(c)(l)(F)(vi) 4 9 ------- |