Implementing the Pesticide Registration Improvement Act - Fiscal Year 2018 Fifteenth Annual Report ------- Table III Number of PRIA Actions Completed in fiscal year 2015, 2016, 2017, and 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 PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 R010 New active ingredient, food use 23 8 16 5 917 1186 934 860 R020 New active ingredient, food use, reduced risk 10 6 15 690 711 709 R060 New active ingredient, non-food use, outdoor 10 3 727 737 R090 New active ingredient, non-food use, outdoor, EUP 1 466 R110 New active ingredient, non-food use, indoor 1 327 R124 Conditional ruling on pre-application study waivers; applicant-initiated 10 6 6 10 199 104 170 116 R140 Additional food use; indoor; food/food handling 8 2 494 1119 R150 New use, first food use 2 1 3 1554 2040 728 R170 New use, additional food use 82 122 92 94 486 562 560 640 R175 Additional food uses covered within a crop grouping/conversion 38 65 17 40 433 527 439 566 R180 New use, additional food use; reduced risk 2 14 24 15 494 607 457 396 R190 New use, additional food uses; 6 or more submitted in one application 30 52 25 19 533 519 541 564 1 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 R200 New use, additional food uses; 6 or more submitted in one application; reduced risk 3 12 359 640 R230 New use, additional use; non-food; outdoor 11 12 8 9 476 632 718 461 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 1 198 264 122 R251 EUP, non-crop destruct, no change to tolerance 3 1 1 259 695 140 R260 New use; non-food; indoor 5 7 1 5 482 611 369 384 R270 New use; non-food; indoor; reduced risk 1 1 2 359 437 R272 Review of study protocol; applicant-initiated; excludes DART, pre- registration conferences, rapid response review, DNT protocol review, protocols needing HSRB review 25 29 40 20 77 70 61 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 1 10 4 4 360 458 687 456 R275 Rebuttal of agency reviewed protocol; applicant-initiated 1 21 R280 Establish import tolerance; new active ingredient or first food use 1 2 3 854 635 613 R290 Establish import tolerance; additional food use 7 2 14 7 416 473 471 536 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 4 13 4 4 759 462 399 437 R295 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 1 1 616 462 R296 Establish rotational crop tolerances; 6 or more crops 1 491 R298 Amend established tolerance and amended labels 19 18 11 13 428 571 435 661 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; 127 108 128 204 107 101 106 111 2 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 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. 49 60 65 89 110 108 119 118 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 90 73 86 97 224 207 207 214 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 44 33 21 37 233 264 234 260 R315 New end use, non-food animal product with 2 animal safety studies 5 14 14 2 271 223 242 255 R320 New product; new physical form; requires data review in science divisions 21 15 15 11 367 403 347 372 R331 New product; repack of identical registered end-use product as a manufacturing-use product; same registrant uses only 3 3 3 2 38 51 79 58 R333 New product with unregistered source of a.i..; cite-all or selective data citation where applicant owns all required data 24 34 28 38 264 270 271 299 R334 New product with unregistered source of a.i.; selective data citation 22 21 50 42 354 318 321 326 R340 Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient) 117 90 108 91 107 92 111 110 3 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 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) 60 48 39 24 343 335 254 304 R351 Amendment adding new unregistered source of Al 89 73 82 96 204 203 208 215 R352 Amendment adding already approved uses; 6 3 6 237 203 133 R370 Cancer reassessment; applicant-initiated 3 1 3 386 665 698 R371 Amendment to EUP 2 2 99 141 R.30 Footnote 3-30 calendar days to reach agreement on label 4 7 63 11 R.LR Footnote 3 - Agency label review within 2 business days 15 4 25 23 2 2 A420 New active ingredient, non-food use, indoor FIFRA §2(mm) uses 1 12 1 1 2075 997 732 182 A440 New use, first food use, establish tolerance exemption 1 532 A460 Additional food use; establish tolerance exemption 1 1 3 485 456 1594 A480 New use, additional use; non-food; outdoor; FIFRA §2(mm) uses 3 2 268 273 A490 New use, additional use; non-food; outdoor; uses other than FIFRA §2 (mm) 1 405 A500 New use, additional use; non-food; indoor; FIFRA §2(mm) uses 5 1 2 1082 276 271 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 7 8 6 10 184 90 94 85 A522 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant- initiated; Tier 2 2 2 420 355 A523 Protocol review; other than public health efficacy 1 1 268 212 4 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 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. 36 28 42 26 107 104 100 109 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. 16 21 11 18 120 121 119 120 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 17 8 8 6 147 147 155 150 A540 New end use product; FIFRA §2(mm) uses only 84 80 85 69 179 167 166 151 A550 New end-use product; uses other than FIFRA §2(mm); non-FQPA product 8 3 3 3 173 209 216 211 A560 New manufacturing-use product; registered active ingredient; selective data citation 2 14 7 9 347 393 315 341 A570 Label amendment requiring data submission 139 134 132 132 117 119 116 116 A572 New product or amendment (REI, PPE, use rate changes) 2 3 3 365 266 233 A.30 Footnote 3-30 calendar days to reach agreement on label 18 17 22 21 9 14 A.LR Footnote 3 - Agency label review within 2 business days 19 19 21 2 1 3 B590 New active ingredient; food use; establish tolerance exemption, microbial/biochemical 25 17 11 110 553 600 605 361 B600 New active ingredient; non-food use, microbial/biochemical 5 3 2 786 417 507 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 1 73 84 74 94 5 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 B620 Non-food use; experimental use permit application 2 1 132 210 B621 Extend or amend EUP, microbial/biochemical 6 3 3 3 113 153 140 171 B630 First food use; establish tolerance exemption, microbial/biochemical 6 4 2 530 851 217 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 2 241 119 B650 New use, non-food 4 1 211 212 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 15 16 17 9 110 75 100 83 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 21 32 22 18 210 165 210 194 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 1 518 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 9 7 9 389 333 374 380 6 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 B673 New product; unregistered source; citation of TGAI data previously reviewed 5 2 6 6 354 267 281 294 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 18 8 19 15 139 116 190 127 B681 Label amendment; unregistered source of active ingredient; supporting data require scientific review, microbial/biochemical 6 5 11 14 229 148 169 198 B682 Protocol review; applicant-initiated; excludes time for HSRB review (pre-application), microbial/biochemical 5 2 6 3 61 59 78 29 B683 Label amendment; requires update of RA (REI, PPE, PHI changes) 1 1 2 117 351 137 B690 SCLP, new active ingredient; food or non-food use 1 2 217 208 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 1 100 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 12 9 3 4 136 128 123 119 B721 SCLP, new product; unregistered source of active ingredient 2 3 4 149 211 203 B730 SCLP, label amendment requiring data submission 1 1 1 1 113 147 43 92 B740 Plant-incorporated protectants (PIP), EUP; registered active ingredient; non-food/feed or crop destruct basis; no Scientific Advisory Panel (SAP) review required 1 182 7 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 B771 PIP, experimental use permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required 5 2 2 315 305 318 B772 PIP, amend or extend EUP; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected 1 2 1 92 86 89 B773 Amend or extend an EUP; extend temporary tolerance or exemption 2 1 2 147 146 212 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 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 1 3 7 2 268 316 302 277 B881 PIP; new product; SAP review 2 436 B883 PIP; seed increase with negotiated acreage cap and time-limited registration; petition to establish permanent tolerance/tolerance exemption based on temporary tolerance/tolerance exemption 2 287 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 2 9 1 273 262 276 248 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 95 156 B903 Inert Ingredient tolerance exemption; reviewed in BPPD 1 304 1001 New food use inert 13 17 11 8 463 509 474 643 I002 Amend currently approved inert tolerance; new data 1 2 2 3 349 447 401 531 I003 Amend currently approved inert tolerance; no new data 2 1 1 2 290 233 376 350 I004 New non-food use inert 18 7 10 7 200 210 202 259 I005 Amend currently approved non-food use inert ingredient with new use pattern; new data 1 238 I006 Amend approved non-food use inert 1 135 I007 Substantially similar non-food use inert 1 1 5 1 120 121 117 121 8 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2015 FY 2016 FY 2017 FY 2018 FY 2015 FY 2016 FY 2017 FY 2018 1008 Approval of new polymer inert; food use 8 14 7 9 171 155 201 193 1009 New polymer inert ingredient 12 4 5 8 90 87 108 108 1010 Amend tolerance exemption descriptor to add CASRNs 1 2 1 253 182 235 M001 Human Studies protocol review - HSRB 1 1 1 4 105 213 256 260 M002 Completed human study HSRB review 2 6 273 128 M005 New product, combination of Als across divisions 1 3 4 1 253 265 270 294 M006 Gold Seal letter 611 639 540 571 -6 -3 2 1 M007 Extend exclusive use of data 3(c)(1)(F)(ii) 6 1 1 3 369 363 337 407 M008 Extend exclusive use of data 3(c)(1)(F)(vi) 1 4 488 474 TOTAL 2111 2174 2026 2206 9 ------- |