Implementing the Pesticide Registration Improvement Act - Fiscal Year 2013 Tenth Annual Report March 1, 2014 ------- Table III Number of PRIA Actions Completed in fiscal year 2010, 2011, 2012, and 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 PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 R01 New active ingredient, food use 3 1106 R010 New active ingredient, food use 11 51 20 703 910 731 R020 New active ingredient, food use, reduced risk 6 587 R06 New active ingredient, non-food use, outdoor 4 1433 R060 New active ingredient, non-food use, outdoor 29 2 686 1069 R10 New active ingredient, non-food use, outdoor, submitted after EUP 3 1199 R110 New active ingredient, non-food use, indoor 3 3 630 1024 R120 New active ingredient, non-food use; indoor; reduced risk 2 755 R123 New active ingredient, seed treatment only 2 718 R124 Conditional ruling on pre-application study waivers; applicant-initiated 2 3 1 5 179 164 164 175 R140 Additional food use; indoor; food/food handling 3 7 6 399 548 455 R150 New use, first food use 2 11 1224 673 R17 New use, each additional new food use 4 4 1146 2098 R170 New use, additional food use 105 59 108 138 453 508 467 524 1 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 R180 New use, additional food use; reduced risk 13 6 27 336 595 277 R19 New use, additional new food uses, bundled, 6 or more 10 3 1829 1548 R190 New use, additional food uses; 6 or more submitted in one application 36 43 59 32 464 529 519 526 R200 New use, additional food uses; 6 or more submitted in one application; reduced risk 19 9 5 17 324 591 328 425 R210 Additional food use; experimental use permit application; establish temporary tolerance; no credit toward new use registration 2 3 2 368 341 389 R220 New use, additional food use; EUP; crop destruct basis; no credit toward new use registration 1 181 R230 New use, additional use; non-food; outdoor 13 16 19 9 441 572 481 442 R250 New use, additional use; non-food; outdoor; EUP; no credit toward new use registration 4 2 4 158 82 122 R260 New use; non-food; indoor 4 4 6 5 491 375 205 606 R270 New use; non-food; indoor; reduced risk 1 1 258 350 R272 Review of study protocol; applicant-initiated; excludes DART, pre- registration conferences, rapid response review, DNT protocol review, protocols needing HSRB review 20 43 22 21 64 76 72 99 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 8 7 6 3 373 390 588 300 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 2 5 586 470 R28 Import tolerance, new active ingredient or first food use 1 1155 R280 Establish import tolerance; new active ingredient or first food use 3 2 1 572 694 632 R29 Import tolerance, additional new food use 1 2485 R290 Establish import tolerance; additional food use 5 4 4 7 480 496 431 357 R292 Amend an established tolerance (e.g., decrease or increase); 22 7 6 14 399 311 385 324 2 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 domestic or import; applicant-initiated R295 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 1 5 506 448 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. 277 231 194 157 84 79 73 92 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. 36 40 24 59 123 138 131 108 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 167 250 225 178 204 198 190 186 R311 New product; requires approval of new food-use inert; applicant- initiated; excludes approval of safeners 2 3 1 406 353 365 R312 New Product; requires approval of new non-food use inert; applicant initiated 1 179 R313 New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated 1 2 654 279 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 10 236 R315 New end use, non-food animal product with 2 animal safety studies 2 63 3 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 R32 New product, non-fast track, new physical form (excludes selective citations) 1 797 R320 New product; new physical form; requires data review in science divisions 17 15 15 14 347 371 380 382 R330 New manufacturing-use product; registered active ingredient; selective data citation 8 6 6 12 360 320 354 313 R331 New product; repack of identical registered end-use product as a manufacturing-use product; same registrant uses only 4 6 2 23 72 65 22 61 R333 New product with unregistered source of Al;cite-all or selective data citation where applicant owns all required data 1 220 R334 New product with unregistered source of Al; selective data citation 1 5 R340 Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient) 162 218 228 193 113 116 116 108 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) 81 67 43 54 266 276 284 279 R351 Amendment adding new unregistered source of Al 15 147 R37 Cancer reassessment, applicant initiated 1 1185 R370 Cancer reassessment; applicant-initiated 2 1 2 534 535 349 A380 Food use; establish tolerance exemption 4 392 A400 New active ingredient; non-food use; outdoor; FIFRA §2(mm) 1 1692 A41 New active ingredient, non-food use, outdoor, other uses 2 1798 A42 New active ingredient, non-food use, indoor, FIFRA sec. 2(mm) uses 1 1864 A420 New active ingredient, non-food use, indoor FIFRA §2(mm) uses 3 4 736 1204 A460 Additional food use; establish tolerance exemption 5 2 4 1 620 432 740 -5 A470 New food use, additional food use; establish tolerance A480 New use, additional use; non-food; outdoor; FIFRA §2(mm) uses 3 2 7 356 151 406 A490 New use, additional use; non-food; outdoor; uses other than FIFRA 1 1 363 1239 4 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 §2 (mm) A500 New use, additional use; non-food; indoor; FIFRA §2(mm) uses 19 1 6 9 309 273 244 365 A510 Additional use; non-food; indoor; uses other than FIFRA section 2(mm) 1 1 496 748 A520 Experimental use permit application 1 4 1 321 403 274 A521 Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 4 11 8 12 208 143 177 204 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 1 797 622 829 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. 57 55 89 64 97 95 91 112 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. 8 19 19 14 124 186 128 119 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 19 15 15 17 124 130 143 139 A54 New product, non-fast track, FIFRA sec. 2 (mm) uses 1 1261 A540 New end use product; FIFRA §2(mm) uses only 65 66 69 74 190 159 193 192 A550 New end-use product; uses other than FIFRA §2(mm); non-FQPA product 1 7 7 8 270 179 218 263 5 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 A560 New manufacturing-use product; registered active ingredient; selective data citation 2 8 7 7 530 262 385 368 A570 Label amendment requiring data submission 120 151 99 108 145 136 180 129 A572 New product or amendment (REI, PPE, use rate changes) 1 38 B59 New active ingredient, food use, with exemption, microbial/biochemical 8 914 B590 New active ingredient; food use; establish tolerance exemption, microbial/biochemical 18 10 38 21 634 734 692 771 B60 New active ingredient, non-food use, microbial/biochemical B600 New active ingredient; non-food use, microbial/biochemical 6 6 14 9 392 681 541 469 B610 Food use; EUP; establish temporary tolerance exemption, microbial/biochemical 2 222 B620 Non-food use; experimental use permit application 2 3 2 103 143 326 B621 Extend or amend EUP, microbial/biochemical 4 8 3 69 37 33 B63 New use, first food use, with tolerance exemption microbial/biochemical, 3 1233 B630 First food use; establish tolerance exemption, microbial/biochemical 12 614 B631 Amend established tolerance exemption, microbial/biochemical 1 2 6 4 471 389 243 393 B641 Amend established tolerance 1 276 B650 New use; non-food, microbial/biochemical 2 209 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 11 12 22 6 106 61 85 85 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 11 16 13 17 188 262 189 211 6 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 request for data waivers supported by scientific rationales, microbial/biochemical 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 7 529 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 6 16 11 404 334 374 358 B673 New product; unregistered source; citation of TGAI data previously reviewed 1 192 B680 Label amendment requiring data submission, microbial/biochemical 12 20 13 12 169 103 89 115 B681 Label amendment; unregistered source of active ingredient; supporting data require scientific review, microbial/biochemical 7 5 6 3 227 263 281 183 B682 Protocol review; applicant-initiated; excludes time for HSRB review (pre-application), microbial/biochemical 1 1 4 2 84 52 64 79 B690 SCLP, new active ingredient; food or non-food use 5 1 1 167 169 140 B700 SCLP, experimental use permit application; new active ingredient or new use 1 120 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 92 67 B720 SCLP, new product; registered source of active ingredient; all Tier I 3 3 2 107 130 141 7 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 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 B721 SCLP, new product; unregistered source of active ingredient 5 4 2 2 185 185 160 176 B730 SCLP, label amendment requiring data submission 2 3 1 1 129 158 122 111 B740 Plant-incorporated protectants (PIP), EUP; registered active ingredient; non-food/feed or crop destruct basis; no Scientific Advisory Panel (SAP) review required 2 208 B771 PIP, experimental use permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required 2 1 370 280 B772 PIP, amend or extend EUP; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected 3 1 2 54 90 90 B773 PIP, amend or extend existing experimental use permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption 4 177 B800 PIP, new active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required 1 8 357 773 B84 PIP, register new active ingredient, set tolerance or exemption, SAP 2 1052 B851 New active ingredient, different genetic event of previously approved Al; same crop; no tolerance action required no SAP 1 394 B870 PIP, new use 1 269 B880 PIP, new product; no SAP review required 20 5 6 7 395 274 259 270 B881 PIP, new product; SAP review required 1 3 3 697 458 456 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 6 1 4 181 179 178 142 B902 PIP protocol review 1 84 8 ------- PRIA Category Description of Category Number Completed PRIA Decisions Average Decision Time in Days FY 2010 FY 2011 FY 2012 FY 2013 FY 2010 FY 2011 FY 2012 FY 2013 B903 Inert ingredient tolerance exemption; reviewed in BPPD 1 184 1002 Amend currently approved inert tolerance; new data 2 254 1003 Amend currently approved inert tolerance; no new data 1 273 1008 Approval of new polymer inert; food use 4 124 M006 Gold Seal letter 561 -13 M007 Extend exclusive use of data 3(c)(1)(F)(ii) 1 226 TOTAL 1517 1554 1574 2048 9 ------- |