Implementing the Pesticide Registration Improvement Act - Fiscal Year 2014 Eleventh Annual Report March 1, 2015 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 Pesticide Registration Service Fees Acc : "" -- Progress in Meeting Decision Times Number of PF ' Hons Completed it The EPA counts "decisions," rather than registration applications, and each application package can require more than one decision. The number of decisions that have to be made within an application depends on the number of product registrations and tolerance petitions in the application. For instance, one conventional new non-food outdoor use application package required five decisions, one for each product label being amended. One decision is designated as a "primary" decision, while the others are "secondary" decisions within the application package in the agency's tracking systems. Generally, each application categorized as a Fast Track, Non-Fast Track New Product, identical/substantially similar new product, new product, Non-Fast Track Amendment or label amendment submitted with data, contains a single product and is a single decision. EPA completed 1,919 decisions subject to PRIA during FY' 14. In addition, 12 non-PRIA inert clearances, which were submitted before inert clearances became a covered pesticide activity under PRIA 3, were also completed during FY' 14 making the total number of completed decisions equal to 1,931. FY'14 completions represent a 7% decrease over the 2,084 decisions completed in FY'13. This decrease is likely due to the government shutdown in October 2013. Among the FY' 14 completed decisions, 287 (15% of total) were antimicrobial decisions, 129 (7%) biopesticide decisions, 895 (46%) conventional pesticide decisions, 45 (2%) inert clearances and 575 (30%) miscellaneous decisions. Table III titled "Number of PRIA Actions Completed in FY 201 1, 2012, 2013 and 2014" summarizes the number of decisions completed by each PRIA category and compares the first two years under PRIA 3 (FY' 13 & FY' 14) with the last two fiscal years under PRIA 2 (FY' 11 & FY' 12). An additional 153 applications were withdrawn - a slight increase from the number withdrawn in FY' 13 (138 applications) but fewer than in FY' 11. FIFRA Section 33(f)(4)(B), "Initial Content and Preliminary Technical Screenings" first directs the agency, not later than 21 days after receiving an application and the required registration service fee, to conduct an initial screening of the contents of the application, and if the application fails the content screen and cannot be corrected by the applicant within the 21 day period, the agency is to reject the application. During FY' 14 nine applications were rejected/withdrawn for significant "content" deficiencies. In FY' 13, FY12, and FY' 11, six, four and eight applications, respectively, were rejected/withdrawn as a result of the 21-day content screen. Second, the Preliminary Technical Screen directs the agency to screen the application to determine if the data are accurate, complete and consistent with the proposed labeling and/or tolerance. The technical screen is to be completed not later than 45/90 days after the PRIA start date, and if the application fails the technical screen and cannot be corrected within 10 business days, the agency is to reject the application. During FY' 14, Preliminary Technical Screens were completed for 1,600 PRIA 3 submissions. 149 10-day deficiency letters were sent out resulting in 49 applications being rejected or withdrawn. Nineteen conventional chemical applications were withdrawn, and two applications were formally rejected. Ten antimicrobial packages were withdrawn, and five were rejected. Twelve BPPD applications were withdrawn, and one was rejected. Page 1 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 Reasons for applications being rejected or withdrawn as a result of the Preliminary Technical Screen include: - Not substantially similar; Missing data; Data deficiencies; Inadequate acute toxicity data; Uncleared inerts; Waiver request for post-application exposure study denied; Unacceptable bridging arguments; Data matrix/data comp issues - New AI rejected for inadequate characterization of the strain; Rejected applications are not counted as completed decisions. Number Decisions Completed in Number Withdrawn in Fiscal Year Fiscal Year Type of Pesticide 2011 2012 2013 2014 2011 2012 2013 2014 Conventional 1074 1068 1039 895 121 95 87 89 Antimicrobial 346 333 329 287 24 18 43 34 Biopesticide 134 173 111 129 20 10 8 30 Inert 43 45 0 0 Miscellaneous 562 575 0 0 Total 1554 1574 2084 1931 165 123 138 153 The EPA completed 85 percent of all decisions on or before their original or extended PRIA due date. In FY' 14, 292 decisions (out of 1,931 completed decisions) were late due to the government shutdown in October 2013 and the "short term strategy" implemented by EPA to reduce the backlog created by the shutdown. Average Decision Times The average decision time for each PRIA category, shown in Table III, is the number of days it took the agency to complete a decision once the application was received and payment was made or a fee waiver or an exemption was granted. The mandated time frame or decision review time-period changed from one fiscal year to another as prescribed by statute and depends on the fiscal year in which an application was received. Meaningful comparisons in average decision times can only be made for those fee categories with a significant number of completed decisions. In comparison to FY'13, average decision review times in FY' 14 seemed to increase across the board for new product submissions, most new active ingredient submissions, tolerances and most amendment submissions. Exceptions to this across the board increase in average decision review times would include several conventional new use Page 2 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 category submissions, and an AD amendment category submission where the average decision review times decreased. BPPD's major new active ingredient category submissions remained almost the same (i.e., increased on average by only one day). Due Date Extensions (Negotiated Due Dates) Among the FY'14 completions, we extended due dates for 340 decisions (17.6%) by mutual agreement with the applicant. The percentage of decisions completed with due date extensions increased slightly in FY'14 from FY'13 (17.6% vs 15%). Due to the government shutdown, FY'14 renegotiation percentages are somewhat of a special case. To deal with the backlog of PRIA actions which resulted from the two- week shutdown, OPP eschewed renegotiating PRIA due dates in favor of utilizing that time and resource to reduce the backlog. This was referred to as "the short term strategy". This strategy was in place from the middle of October 2013 to the middle of January 2014. In addition to the cascading effects of the shutdown, extensions generally were needed because of missing or deficient data or risk issues. In FY'14 we extended due dates for 14.3%, 23.2%, and 28.9% of completed antimicrobial, biopesticide, and conventional decisions respectively, while in FY' 13, the percentages we extended were 22.2%, 30.6% and 19.7% respectively. Number of Completed Decisions with Due Date Extensions Compared to Total Completed FY 2011 FY 2012 FY 2013 FY 2014 Fee Category Number due date extensions Total Number due date extensions Total Number due date extensions Total Number due date extensions Total Antimicrobial (A) 85 346 86 333 73 329 41 287 Biopesticide (B) 48 134 74 173 34 111 30 129 Conventional (R) 236 1074 235 1068 205 1039 259 895 Inerts - - - - 1 43 9 45 Miscellaneous - - - - - 562 1 575 Total Decisions 369 1554 395 1574 313 2084 340 1931 As discussed previously, an active ingredient or a new use application package can include a number of decisions to account for the number of registrations and tolerances requested for the new active ingredient or new use. All of the decisions associated with these applications are linked to one decision that has been designated as the "primary" decision with the rest termed "secondary" decisions. A new product or amendment application package will have only one decision in the agency's tracking system; however, some new product and amendment applications are dependent upon the data submitted with another application, the primary decision, as described in the primary/secondary guidance. If there are data issues, the due dates for both the primary and all of its secondary decisions will be extended. Page 3 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 Consequently, an analysis of due date extensions using decisions can only indicate trends from one fiscal year to another. To conduct a more detailed analysis, the agency focused on primary decisions. Number of Completed Primary Decisions with Due Date Extensions Compared to Total Completed FY 2011 FY 2012 FY 2013 FY 2014 Fee Category Due Date Extensions Total Due Date Extensions Total Due Date Extensions Total Due Date Extensions Total Antimicrobial (A) 70 292 71 304 64 285 41 256 Biopesticide (B) 31 112 43 136 16 88 19 106 Conventional (R) 153 880 127 800 109 797 159 678 Inerts _ _ _ _ 1 43 9 45 Miscellaneous _ _ _ _ 0 562 1 575 Total Decisions 254 1284 241 1240 190 1775 229 1660 If only primary decisions are considered, 13.8% had due date extensions in FY' 14 according to the agency's tracking systems, an increase from the 10.7% in FY' 13. Of the primary decisions, due dates for 16% of antimicrobial, 17.9% of Biopesticide, and 23.4% of conventional primary decisions were extended, in comparison to 22.4%, 18.2% and 13.7% respectively in FY' 13. The following general types of decisions involved due date extensions in FY' 11 - FY' 14: Number of Decisions with Due Date Extensions by Type of Decision (All Decisions) Fiscal Year New Active Ingredient New Uses New Products Amendments Inerts Misc Other (EUP, tolerances, protocols, etc.) Total with Due Date Extensions 2011 21 111 154 64 - - 19 369 2012 113 86 119 56 - - 21 395 2013 40 103 92 49 1 0 28 313 2014 47 79 95 67 9 1 42 340 In FY'14 80% of completed new active ingredient decisions required due date extensions; 40% of completed new use decisions required due date extensions; 18% of completed new product decisions required due date extensions; 16% of completed amendment decisions required due date extensions; Page 4 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 20% of completed inert decisions required due date extensions; 38% of completed other (EUP, tolerance, protocol review, cancer reassessment) decisions required due date extensions, and <1% of completed miscellaneous decisions required due date extensions. When only primary decisions are considered, the breakdown of decision types looks like this: Number of Primary Decisions with Due Date Extensions by Type of Primary Decision Fiscal Year New Active Ingredient New Uses New Products Amendments Inerts Misc Other (EUP, tolerances, protocols, etc.) Total with Due Date Extensions 2011 11 39 142 45 - - 17 254 2012 36 30 115 43 - - 17 241 2013 18 35 77 37 1 0 22 190 2014 14 28 87 53 9 1 37 229 In FY'14 70% of completed, new active ingredient, primary decisions required due date extensions; 35% of completed, new use, primary decisions required due date extensions; 17% of completed, new product, primary decisions required due date extensions; 16% of completed, amendment, primary decisions required due date extensions; 20% of completed, inert, primary decisions required due date extensions; 38.5% of completed, other (EUP, tolerance, protocol review, cancer reassessment), primary decisions required due date extensions and < 1% of completed miscellaneous primary decisions required due date extensions. Antimicrobials Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary Decisions - Antimicrobials Fiscal Year FY 2011 FY 2012 FY 2013 FY 2014 Type Number with Extensions Total Number with Extensions Total Number with Extensions Total Number with Extensions Total New Active Ingredient 1 3 3 4 4 4 0 1 New Uses 2 6 2 8 6 14 4 10 New Products 47 162 46 200 35 173 18 131 Amendments 15 106 11 81 11 80 9 95 Other (tolerances, EUP protocols, etc.) 5 15 9 11 8 14 10 19 Total with Extensions 70 292 71 304 64 285 41 256 In FY'14 the percentage of antimicrobial primary decisions with a due date extension (16%) was down from FY'13 (22.4%). Page 5 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 Biopesticides Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary Decisions - Biopesticides Fiscal Year FY 2011 FY 2012 FY 2013 FY 2014 Number Number Number Number Type with Extensions Total with Extensions Total with Extensions Total with Extensions Total New Active Ingredient 8 10 22 28 8 13 8 12 New Uses 5 7 2 2 0 0 1 14 New Products 11 48 14 65 6 41 7 51 Amendments 4 32 3 21 0 20 1 15 Other (tolerances, EUP,protocols, etc.) 3 15 2 20 2 14 2 14 Total with Due Date Extensions 31 112 43 136 16 88 19 106 In FY'14 the percentage of biopesticide primary decisions with due date extensions (18%) was almost the same as in FY'13 (18.2%). Conventional Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary Decisions - Conventional Pesticides Fiscal Year FY 2011 FY 2012 FY 2013 FY 2014 Type Number with Extensions Total Number with Extensions Total Number with Extensions Total Number with Extensions Total New Active Ingredient 2 4 11 12 6 9 6 7 New Uses 32 60 26 69 29 75 23 56 New Products 84 524 55 449 36 443 62 323 Amendments 26 235 29 236 26 221 43 229 Other (EUP, tolerances, protocols, etc.) 9 57 6 34 12 49 25 63 Total with Due Date Extensions 153 880 127 800 109 797 159 678 In FY'14 the percentage of conventional primary decisions with a due date extension (23%) increased substantially from FY'13 (13.7%). Page 6 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 Note: Appendix A lists all applications subject to PRIA completed during FY' 14_with the decision time for each decision. Pub iicipation Process Federal pesticide law includes only limited requirements for public participation in the pesticide registration process. In response to the President's directive on transparency and open government, the EPA explored opportunities for expanding the openness of the process, and in October 2009, began implementing a public participation process for certain registration actions. This process increased the public's opportunities to comment on risk assessments and proposed registration actions. Both the EPA and the public benefit from a public participation process because the public can aid in understanding potential risks and benefits, contribute to meaningful protective measures, and improve the public dialogue on pesticide registration decisions. The public participation process is used for the following types of applications: • new active ingredients, • first food use, • first outdoor use, • first residential use, and • other actions of significant interest. In FY' 14 the agency issued 20 PRIA actions for public comment, of those, 1 was an antimicrobial pesticide, 12 were biopesticides, and 7 were conventional chemicals. For additional information, please see http://www.epa.gov/pesticides/regulating/registration-public~involvement.html. Antimicrobial Tit rnies Section 33(k)(2)(E) directs the EPA to review its progress in meeting the timeline requirements for the review of antimicrobial pesticide products under section 3(h). The timeline requirement under section 3(h) for substantially similar or identical products is 90 days. Under PRIA 3, antimicrobial substantially similar or identical products fall under one of three fee categories, A530, A531 and A532. PRIA 3 time frames were 4 months for an A530 and an A531 and 5 months for an A532. Of the 39 decisions in fee category A530 completed in FY' 14, 10 (26%) were completed within 90 days and 20 (51%) were completed within the four month PRIA time frame, and 9 (23%) were completed late. In comparison, of the 64 decisions in fee category A530 completed in FY'13, 20 (31%) were completed within 90 days, and 40 (63%) were completed within the PRIA time frame and 4 (6%) met their extended (renegotiated) due dates. Of the 34 other substantially similar or identical products in fee categories A531 and A532, 28 were completed within their PRIA time frames, one met its extended (renegotiated) due date, and 5 were late. For other new product decisions in fee categories A540, and A550, the section 3(h) time frame is 180 days with a goal of reducing the review time to 120 days. Of the 58 FY' 14 decisions in these fee categories, 0 were completed within 120 days; 38 (66%) were completed within 180 days; 10 (17%) were completed within their extended PRIA due date, and 10 (17%) were late. Page 7 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 In response to the government shutdown in October 2013, the Agency eschewed renegotiating PRIA due dates in favor of utilizing that time and resources to reduce the backlog created by the shutdown. This has been referred to as the "short term strategy" which was in place from the middle of October 2013 to the middle of January 2014. Consequently, the late completions described above should probably be considered in view of this "short term strategy". ticidc Incident Data System Section 33(k)(2)(I) requires the EPA to report on the progress in updating the Incident Data System and making the data available to the public. The EPA has made improvements in the electronic recording of incident data received through FIFRA 6(a)(2) data as well as from consumer reporting. Through the EPA's cooperative agreement with the National Pesticide Information Center at Oregon State University, the more recently established ecological and pet reporting portals have been successful in providing more detailed information regarding incidents related to companion animals as well as bee kills from sources such as states, veterinarians, bee keepers and wildlife rehabilitation facilities. The EPA uses this incident information when developing risk mitigation options during the risk assessment process to ensure the continued safe use of pesticide products. Also, trends in incident data can be used at any time to mitigate potential emerging concerns. EPA provides this incident information to other federal agencies, states and EPA regions on a regular basis and provides information to public inquiries through the FOIA process. Sources of Pesticide Usage Data Section 33(k)(2)(J) requires the EPA to summarize the sources of publicly available pesticide usage data. FEDERAL SOURCES USDA Pesticide Usage Data Sources http://www.nass.usda.gov/Aboiit NASS/index.asp USDA National Agricultural Statistics Service (NASS):_NASS conducts farmer surveys to collect pesticide- usage data on major field (e.g., corn, cotton, and soybean), vegetable, and fruit crops in states that account for the bulk of production of these crops. These data are collected based on surveys and updated at various frequencies determined by USDA. Census of Agriculture:_NASS also produces the USDA Census of Agriculture, which consists of uniform, comprehensive data on agricultural production and operator characteristics in each county and state, as well as the U.S. as a whole. Crop Profiles: USDA produces Crop Profiles that provide information in narrative format about crop production, cultural practices, and pesticide usage. Each Crop Profile describes how a commodity is produced, with emphasis on critical pest management needs - including the role of pesticides in integrated pest management (IPM) and resistance management programs. USGS - http://water.usgs.gov/nawqa/pnsp/usage/maps/: USGS provides pesticide-use maps showing the geographic distribution of estimated use on agricultural land in the conterminous United States for numerous pesticides. Page 8 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 STATE SOURCES California Department of Pesticide Regulation http://www.cdpr.ca.gov/docs/label/labelque.htm: California Department of Pesticide Regulation collects usage information by conducting a pesticide-usage census in the state. Data collection is annual for all agricultural uses and offers site-specific information. New Jersey - http://www.pestmanagement.rutgers.edu/ni inpas/pesticidesurvevs .htm: Through collaboration with Rutgers University, the New Jersey Department of Environmental Protection Pesticide Control Program (NIDEP) collects pesticide use information from private applicators in New Jersey. These surveys are conducted every three years. New York - http://ai.psur.comell.edu/: In collaboration with Cornell University, the State of New York collects Pesticide Use data from commercial applicators, who are required to report each pesticide application, at least annually. Oregon - http://www.oregon.gov/ODA/shared/Documents/Publications/PesticidesPARC/PesticideusereportingsvstemAnnu alreport2006.pdf: Due to state budget constraints. Oregon discontinued its pesticide use surveys. However, pesticide usage statistics from 2006-2008 are available on the website. PROPRIETARY SOURCES GfK Kynetec - http://www. gfk.com/Pages/default.aspx: GfK Kynetec is a primary source of proprietary data for agricultural crops. The data are widely used by government entities as well as industry. These data are collected for a large range of row, vegetable, and fruit crops in the continental U.S. and include insecticides, fungicides, herbicides, nematicides, and growth regulators used by producers. Data are collected annually. SIGMA- http://www.gfk.com/us/Pages/default.aspx: SIGMA, a subsidiary of GfK Kynetec, is the primary source for international pesticide usage data for fruits and vegetables. SIGMA provides an annual global study that quantifies the pesticide usage crop-by-crop and by target pest in more than 65 countries. Kline and Company - http ://www Mine group. com/: Kline usage data provides non-agricultural pesticide data profiles of home/garden and professional usage by class/market segment and chemical. Reports cover professional pesticides and fertilizers in the turf and ornamental markets. Number of Pf cations Pent 1 , " 1 Table IV summarizes the pending registration applications (counted as decisions) in each of the PR. IA categories as required by FIFRA Section 33(k)(2)(v). As of September 30, 2014 1,330 decisions subject to PRIA were pending in the agency's registration queue. Numbers pending at the end of FY' 13 and FY'12 are shown for comparison and were, 1,102 and 1,143, respectively. The number of antimicrobial decisions pending at the end of FY' 14 (159) was greater than that at the end of FY' 13 (136) but less than that at the end of FY' 12 (184). The number of biopesticide decisions pending at the end of FY' 14 (145) was greater than that at the end of FY'13 (135) and FY'12 (110). Page 9 of 10 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2014 The number of conventional pesticide decisions pending at the end of FY' 14 (962) was greater than that at the end of FY'13 (794) and FY'12 (875). The number of PRIA inert decisions pending at the end of FY' 14 (51) was greater than that at the end of FY'13 (22). The number of miscellaneous decisions pending at the end of FY' 14 (13) was about the same as those pending at the end of FY' 13 (15). Page 10 of 10 ------- |