Implementing the Pesticide Registration Improvement Act - Fiscal Year 2017 Fourteenth Annual Report S7>% % PRO^ March 1, 2018 ------- Table III Number of PRIA Actions Completed in fiscal year 2014, 2015, 2016, and 2017 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 PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 R010 New active ingredient, food use 10 23 8 16 1087 917 1186 934 R020 New active ingredient, food use, reduced risk 16 10 6 940 690 711 R060 New active ingredient, non-food use, outdoor 10 727 R090 New active ingredient, non-food use, outdoor, EUP 1 606 R110 New active ingredient, non-food use, indoor 1 1 478 327 R123 New active ingredient, seed treatment only 2 861 R124 Conditional ruling on pre-application study waivers; applicant-initiated 5 10 6 6 159 199 104 170 R125 New active ingredient, seed treatment, EUP 1 491 R140 Additional food use; indoor; food/food handling 1 8 2 456 494 1119 R150 New use, first food use 4 2 1 3 1161 1554 2040 728 R170 New use, additional food use 82 82 122 92 515 486 562 560 R175 Additional food uses covered within a crop grouping/conversion 14 38 65 17 325 433 527 439 R180 New use, additional food use; reduced risk 13 2 14 24 306 494 607 457 R190 New use, additional food uses; 6 or more submitted in one application 40 30 52 25 488 533 519 541 1 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 R200 New use, additional food uses; 6 or more submitted in one application; reduced risk 4 3 12 743 359 640 R230 New use, additional use; non-food; outdoor 4 11 12 8 511 476 632 718 R240 New use, additional use; non-food; outdoor; reduced risk 4 421 R250 New use, additional use; non-food; outdoor; EUP; no credit toward new use registration 1 2 198 264 R251 EUP, non-crop destruct, no change to tolerance 1 3 1 358 259 695 R260 New use; non-food; indoor 2 5 7 1 390 482 611 369 R270 New use; non-food; indoor; reduced risk 1 1 1 272 359 437 R272 Review of study protocol; applicant-initiated; excludes DART, pre- registration conferences, rapid response review, DNT protocol review, protocols needing HSRB review 25 25 29 40 89 77 70 61 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 9 1 10 4 354 360 458 687 R280 Establish import tolerance; new active ingredient or first food use 3 1 2 716 854 635 R290 Establish import tolerance; additional food use 10 7 2 14 643 416 473 471 R291 Establish import tolerance; additional food uses; 6 or more crops submitted in one petition 2 1083 R292 Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated 10 4 13 4 561 759 462 399 R293 Establish tolerance(s) for inadvertent residues in one crop, applicant initiated 1 497 R295 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 5 1 560 616 R296 Establish rotational crop tolerances; 6 or more crops 1 491 R298 Amend established tolerance and amended labels 14 19 18 11 380 428 571 435 R299 Amend 6 or more tolerances and amended labels 4 541 R300 New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; 118 127 108 128 115 107 101 106 2 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 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. 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. 33 49 60 65 130 110 108 119 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 96 90 73 86 248 224 207 207 R311 New product; requires approval of new food-use inert; applicant- initiated; excludes approval of safeners 1 1043 R314 New end use product, 2 or more registered active ingredients never before registered as this combination in a formulated product; new product label is substantially similar to labels of currently registered products which separately contain respective component active ingredients 32 44 33 21 235 233 264 234 R315 New end use, non-food animal product with 2 animal safety studies 9 5 14 14 345 271 223 242 R320 New product; new physical form; requires data review in science divisions 10 21 15 15 390 367 403 347 R331 New product; repack of identical registered end-use product as a manufacturing-use product; same registrant uses only 2 3 3 3 94 38 51 79 R333 New product with unregistered source of Al;cite-all or selective data citation where applicant owns all required data 29 24 34 28 305 264 270 271 R334 New product with unregistered source of Al; selective data citation 13 22 21 50 302 354 318 321 R340 Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient) 142 117 90 108 126 107 92 111 3 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 R345 Amending non-food animal product that includes submission of target animal safety data; previously registered 1 213 R350 Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; oradd aerial application; or modify GW/SW advisory statement) 42 60 48 39 372 343 335 254 R351 Amendment adding new unregistered source of Al 83 89 73 82 215 204 203 208 R352 Amendment adding already approved uses; 6 6 3 193 237 203 R371 Amendment to EUP 1 2 2 184 99 141 R370 Cancer reassessment; applicant-initiated 3 1 386 665 R.30 Footnote 3-30 calendar days to reach agreement on label 4 63 R.LR Footnote 3 - Agency label review within 2 business days 15 4 23 2 A380 New active ingredient, food use; establish tolerance exemption 1 332 A420 New active ingredient, non-food use, indoor FIFRA §2(mm) uses 1 12 1 2075 997 732 A440 New use, first food use, establish tolerance exemption 1 532 A460 Additional food use; establish tolerance exemption 2 1 1 454 485 456 A480 New use, additional use; non-food; outdoor; FIFRA §2(mm) uses 1 3 274 268 A490 New use, additional use; non-food; outdoor; uses other than FIFRA §2 (mm) 2 1 835 405 A500 New use, additional use; non-food; indoor; FIFRA §2(mm) uses 6 5 1 389 1082 276 A510 New use, additional use; non-food; indoor; non-FIFRA §2(mm) uses 1 323 A521 Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 13 7 8 6 255 184 90 94 A522 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant- initiated; Tier 2 4 2 2 460 420 355 A523 Protocol review; other than public health efficacy 1 268 4 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 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. 39 36 28 42 113 107 104 100 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. 21 16 21 11 124 120 121 119 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 13 17 8 8 152 147 147 155 A540 New end use product; FIFRA §2(mm) uses only 58 84 80 85 200 179 167 166 A550 New end-use product; uses other than FIFRA §2(mm); non-FQPA product 8 3 3 173 209 216 A560 New manufacturing-use product; registered active ingredient; selective data citation 1 2 14 7 369 347 393 315 A570 Label amendment requiring data submission 124 139 134 132 127 117 119 116 A572 New product or amendment (REI, PPE, use rate changes) 2 2 3 334 365 266 A.30 Footnote 3-30 calendar days to reach agreement on label 18 17 21 9 A.LR Footnote 3 - Agency label review within 2 business days 19 19 2 1 B590 New active ingredient; food use; establish tolerance exemption, microbial/biochemical 21 25 17 11 772 553 600 605 B600 New active ingredient; non-food use, microbial/biochemical 4 5 3 576 786 417 B610 New Al EUP; establish temporary tolerance or exemption 4 308 B612 New Al; no change to permanent tolerance exemption 9 1 405 479 B614 Conditional ruling on pre-application study waivers 1 3 9 73 84 74 5 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 B620 Non-food use; experimental use permit application 1 2 1 231 132 210 B621 Extend or amend EUP, microbial/biochemical 7 6 3 3 106 113 153 140 B630 First food use; establish tolerance exemption, microbial/biochemical 1 6 4 567 530 851 B641 Amend established tolerance 1 332 B643 New food use; petition to amend tolerance exemption 3 5 3 301 293 302 B644 New use, no change to tolerance 1 1 2 336 241 119 B650 New use, non-food 4 211 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 12 15 16 17 113 110 75 100 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 22 21 32 22 235 210 165 210 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 1 1 512 518 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 11 11 9 7 496 389 333 374 6 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 B673 New product; unregistered source; citation of TGAI data previously reviewed 7 5 2 6 267 354 267 281 B674 New product; MUP; repack of identical end-use product; same uses 1 89 B676 New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry must be submitted 1 345 B680 Label amendment requiring data submission, microbial/biochemical 13 18 8 19 125 139 116 190 B681 Label amendment; unregistered source of active ingredient; supporting data require scientific review, microbial/biochemical 3 6 5 11 196 229 148 169 B682 Protocol review; applicant-initiated; excludes time for HSRB review (pre-application), microbial/biochemical 3 5 2 6 58 61 59 78 B683 Label amendment; requires update of RA (REI, PPE, PHI changes) 1 1 117 351 B690 SCLP, new active ingredient; food or non-food use 1 1 2 272 217 208 B700 SCLP, experimental use permit application; new active ingredient or new use 1 310 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 3 1 1 135 100 99 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 3 12 9 3 147 136 128 123 B721 SCLP, new product; unregistered source of active ingredient 2 3 149 211 B730 SCLP, label amendment requiring data submission 1 1 1 113 147 43 B740 Plant-incorporated protectants (PIP), EUP; registered active ingredient; non-food/feed or crop destruct basis; no Scientific Advisory Panel (SAP) review required 1 1 112 182 7 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 B771 PIP, experimental use permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required 5 2 315 305 B772 PIP, amend or extend EUP; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected 1 1 2 1 95 92 86 89 B773 Amend or extend an EUP; extend temporary tolerance or exemption 2 1 147 146 B780 New PIP; non-food/feed 1 399 B790 New PIP; non-food/feed; SAP review 1 300 B800 New PIP, with petition to establish permanent tolerance/tolerance exemption based on an existing tolerance/tolerance exemption 4 405 B820 New PIP with tolerance petition 2 527 B851 New active ingredient, different genetic event of previously approved Al; same crop; no tolerance action required no SAP 1 265 B880 PIP, new product; no SAP review required 7 1 3 7 245 268 316 302 B881 PIP; new product; SAP review 2 436 B884 New PIP, seed increase, acreage cap, time-limited reg, tol exemption 3 365 B885 Registration application, registered PIP, seed increase, breeding stack of approved PIPs 1 1 2 9 276 273 262 276 B890 Application to amend a seed increase registration, converts to commercial registration 2 272 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 95 1001 New food use inert 5 13 17 11 389 463 509 474 I002 Amend currently approved inert tolerance; new data 1 1 2 2 528 349 447 401 I003 Amend currently approved inert tolerance; no new data 3 2 1 1 324 290 233 376 I004 New non-food use inert 6 18 7 10 136 200 210 202 I006 Amend approved non-food use inert 1 1 34 135 I007 Substantially similar non-food use inert 5 1 1 5 110 120 121 117 8 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2014 FY 2015 FY 2016 FY 2017 FY 2014 FY 2015 FY 2016 FY 2017 1008 Approval of new polymer inert; food use 6 8 14 7 166 171 155 201 1009 New polymer inert ingredient 4 12 4 5 94 90 87 108 1010 Amend tolerance exemption descriptor to add CASRNs 2 1 2 1 268 253 182 235 M001 Human Studies protocol review - HSRB 1 1 1 105 213 256 M002 Completed human study HSRB review 2 6 273 128 M005 New product, combination of Als across divisions 2 1 3 4 240 253 265 270 M006 Gold Seal letter 570 611 639 540 -15 -6 -3 2 M007 Extend exclusive use of data 3(c)(1)(F)(ii) 2 6 1 1 313 369 363 337 M008 Extend exclusive use of data 3(c)(1)(F)(vi) 1 1 4 454 488 474 TOTAL 1919 2111 2174 2026 9 ------- |