Implementing the Pesticide Registration Improvement Act - Fiscal Year 2013 Tenth Annual Report March 1, 2014 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 Pesticide Registration Service Fees Acc 1 } • - ess 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 2048 decisions subject to PRIA during FY' 13. In addition, 36 non-PRIA inert clearances, which were submitted before inert clearances became a covered pesticide activity under PRIA 3, were also completed during FY' 13 making the total number of completed decisions equal to 2084. FY' 13 completions represent a 32% increase over the 1574 decisions completed in FY' 12 and a 34% increase over the 1554 decisions completed in FY' 11. This increase is attributed to the completion of 561 Gold Seal Letter decisions completed in FY' 13 - a new PRIA 3 covered category. Among the FY' 13 completed decisions, 329 (16% of total) were antimicrobial decisions, 111 (5%) biopesticides, 1039 (50%) conventional pesticide decisions, 43 (2%) inert clearances and 562 (27%) miscellaneous decisions. Table III titled "Number of PRIA Actions Completed in FY 2010, 2011, 2012 and 2013" summarizes the number of decisions completed by PRIA category and compares the first year under PRIA 3 with the last three fiscal years under PRIA 2. An additional 138 applications were withdrawn - a slight increase from the number withdrawn in FY' 12 (123 applications) but fewer than in FY' 10 and FY' 11.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' 13 six applications were rejected/withdrawn for significant "content" deficiencies. In FY' 12, FY 11, and FY' 10, four, eight and four applications, respectively, were rejected/withdrawn as a result of the 21-day content screen, generally for missing data or incomplete forms. 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' 13, Preliminary Technical Screens were completed for 1,152 PRIA 3 submissions. 110 10-day deficiency letters were sent out resulting Page 1 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 in 22 applications being rejected or withdrawn. Twelve conventional chemical applications were withdrawn and five applications were formally rejected. Rebuttals were entertained for the five conventional chemical packages that were rejected which led to multiple phone conversations and meetings with the registrants; however, none of the rejections were overturned. Three antimicrobial packages were rejected and two were withdrawn. Reasons for applications being rejected or withdrawn as a result of the Preliminary Technical Screen include: - Not substantially similar; Lack of efficacy data to support a public health claim; Efficacy data tested above nominal concentration; Efficacy testing cited was inadequate; Inadequate rationale for changing signal word; Unacceptable bridging arguments; - New product with multiple AIs where acute tox data were submitted on individual AIs and not on mixture; - New AI rejected for the following deficiencies: hydrolysis data submitted not adequate, independent lab validation for aquatic field dissipation studies not submitted, mysid chronic tox study not submitted, fish early-life stage study not submitted, multi-residue methods study not submitted (registrant stated that the study was still ongoing at time of submission), product specific description of the production process not submitted; - New AI withdrawn for the following deficiencies: photodegradation in soil, aerobic aquatic metabolism, anaerobic aquatic metabolism, freshwater invertebrate life-cycle, freshwater fish early life-stage, vascular aquatic plant, estuarine/marine invertebrate acute, estuarine/marine fish, terrestrial field dissipation, environmental chemistry method & independent lab validation. Rejected applications are not counted as completed decisions. Number Completed in Fiscal Year Number Withdrawn in Fiscal Year Type of Pesticide 2010 2011 2012 2013 2010 2011 2012 2013 Conventional 1069 1074 1068 1039 145 121 95 87 Antimicrobial 310 346 333 329 28 24 18 43 Biopesticide 138 134 173 111 16 20 10 8 Inert 43 0 Miscellaneous 562 0 Total 1517 1554 1574 2084 189 165 123 138 Page 2 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 The EPA completed 98.8 percent of all decisions on or before their original or extended PRIA due date. In FY' 13, 25 decisions (out of 2084 completed decisions) missed their statutory due date. Decisions were delayed due to mandatory furloughs, budget cuts and the need for additional time to resolve risk issues to ensure adequate protection of human health and the environment. :isi ' les 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 large number of completed decisions. In comparison to FY' 11, average decision review times in FY' 13 decreased for antimicrobial amendment submissions, for some biopesticide new product submissions, and for some conventional new additional uses, new products and amendment submissions. Average decision review times increased for antimicrobial new uses, efficacy and some new product submissions, for biopesticide new active ingredients, some new product and some amendment submissions and some types of conventional new active ingredients, some new food use, and some new product submissions. Due Date Extensions (Negotiated Due Dates) Among the FY'13 completions, we extended due dates for 313 decisions (15%) by mutual agreement with the applicant. The percentage of decisions completed with due date extensions decreased significantly in FY' 13 from FY' 12 (25%). This percentage decrease is primarily due to the addition of Gold Seal Letters as a new PRIA 3 category which accounted for 561 completed decisions without a single renegotiated due date. Extensions generally were needed because of missing or deficient data or information and risk issues. In FY' 13 we extended due dates for 22.2%, 30.6%, and 19.7% of completed antimicrobial, biopesticide, and conventional decisions respectively, while in FY' 12, the percentages we extended were 25.8%, 42.8% and 22% respectively. [Note that the aggregate percentage of completions with renegotiated due dates for FY' 13 reported above (15%) is less than that reported for each individual division due to the fact that the aggregate percentage also includes the new PRIA 3 Inerts and Miscellaneous categories which are not division-specific.] Page 3 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 Number of Completed Decisions with Due Date Extension Compared to Total Completed FY 2010 FY 2011 FY 2012 FY 2013 Fee Category Number due date extensions Total Number due date extensions Total Number due date extensions Total Number due date extensions Total Antimicrobial (A) 108 310 85 346 86 333 73 329 Biopesticide (B) 85 138 48 134 74 173 34 111 Conventional (R) 277 1069 236 1074 235 1068 205 1039 Inerts - - - - - - 1 43 Miscellaneous - - - - - - 0 562 Total Decisions 470 1517 369 1554 395 1574 313 2084 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. 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 Extension Compared to Total Completed FY 2010 FY 2011 FY 2012 FY 2013 Fee Category Due Date Extensions Total Due Date Extensions Total Due Date Extensions Total Due Date Extensions Total Antimicrobial (A) 89 268 70 292 71 304 64 285 Biopesticide (B) 62 108 31 112 43 136 16 88 Conventional (R) 156 811 153 880 127 800 109 797 Inerts 1 43 Miscellaneous 0 562 Total Decisions 307 1187 254 1284 241 1240 190 1775 Page 4 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 If only primary decisions are considered, 10.7% had due date extensions in FY' 13 according to the agency's tracking systems, a decrease from the 19% in FY' 12. Of the primary decisions, due dates for 22.4% of antimicrobial, 18.2% of Biopesticide and 13.7% of conventional primary decisions were extended, in comparison to 23%, 32% and 16% respectively in FY' 12. The following general types of decisions involved due date extensions in FY' 10 - FY' 13: 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 2010 73 104 181 78 - 34 470 2011 21 111 154 64 - 19 369 2012 113 86 119 56 - 21 395 2013 40 103 92 49 1 0 28 313 In FY' 13 66.7% of completed new active ingredient decisions required due date extensions; 40.4% of completed new use decisions required due date extensions; 13.4% of completed new product decisions required due date extensions; 12.6% of completed amendment decisions required due date extensions; 2% of completed inert decisions and 34.7% of completed other (EUP, tolerance, protocol review, cancer reassessment) decisions required due date extensions. Page 5 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 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 2010 20 37 170 53 - 27 307 2011 11 39 142 45 - 17 254 2012 36 30 115 43 - 17 241 2013 18 35 77 37 1 0 22 190 In FY' 13 69% of completed, new active ingredient, primary decisions required due date extensions; 39% of completed, new use, primary decisions required due date extensions; 11.7% of completed, new product, primary decisions required due date extensions; 11.5% of completed, amendment, primary decisions required due date extensions; 2% of completed, inert, primary decisions and 28.6% of completed, other (EUP, tolerance, protocol review, cancer reassessment), 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 2010 FY 2011 FY 2012 FY 2013 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 New Uses 7 21 2 6 2 8 6 14 New Products 55 149 47 162 46 200 35 173 Amendments 19 90 15 106 11 81 11 80 Other (tolerances, EUP protocols, etc.) 8 8 5 15 9 11 8 14 Total with Extensions 89 268 70 292 71 304 64 285 In FY' 13 the percentage of antimicrobial primary decisions with a due date extension (22.4%) was down slightly from FY' 12 (23.4%). Page 6 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 Biopesticides Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary Decisions - Biopesticides Fiscal Year FY 2010 FY 2011 FY 2012 FY 2013 Type Number with Extensions Total Number with Extensions Total Number with Extensions Total Number with Extensions Total New Active Ingredient 13 19 8 10 22 28 8 13 New Uses 5 7 2 2 0 0 New Products 36 65 11 48 14 65 6 41 Amendments 11 20 4 32 3 21 0 20 Other (tolerances, EUP,protocols, etc.) 2 4 3 15 2 20 2 14 Total with Due Date Extensions 62 108 31 112 43 136 16 88 In FY' 13 the percentage of biopesticide primary decisions with a due date extension (18.2%) was down from FY' 12 (31.6%). Conventional Comparison of Number of Primary Decisions with Due Date Extensions versus Total Number of Primary Decisions - Conventional Pesticides Fiscal Year FY 2010 FY 2011 FY 2012 FY 2013 Type Number with Extensions Total Number with Extensions Total Number with Extensions Total Number with Extensions Total New Active Ingredient 7 7 2 4 11 12 6 9 New Uses 30 70 32 60 26 69 29 75 New Products 79 492 84 524 55 449 36 443 Amendments 23 195 26 235 29 236 26 221 Other (EUP, tolerances, protocols, etc.) 17 47 9 57 6 34 12 49 Total with Due Date Extensions 156 811 153 880 127 800 109 797 Page 7 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 In FY' 13 the percentage of conventional primary decisions with a due date extension (13.7%) was down slightly from FY' 12 (15.9%). The percentage of due date extensions for conventional primary decisions between FY' 10 and FY' 13 consistently decreased a small amount each year from 19.2% in FY' 10 to 13.7% in FY'13. Note: Appendix A lists all applications subject to PRIA completed during FY' 13_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' 13 the agency issued 24 PRIA actions for public comment, of those, 3 were antimicrobial pesticides, 12 were biopesticides, and 9 were conventional chemicals. For additional information, please see http://www.epa.gov/pesticides/reguiating/registration-pubiic- involvement, html. .Antimicrobial Tii limes 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 64 decisions in fee category A530 completed in FY' 13, 20 (31%) were completed within 90 days and 40 (63%) were completed within the four month PRIA time frame, and 4 (6%) met their extended (renegotiated) due dates. In comparison, of the 89 Page 8 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 decisions in fee category A530 completed in FY' 12, 55 (62%) were completed within 90 days, and 77 (87%) were completed within the PRIA time frame. Of the 31 other substantially similar or identical products in fee categories A531 and A532, 27 were completed within their PRIA time frames, and the remaining 4 met their extended (renegotiated) due dates. 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 82 FY' 13 decisions in these fee categories, all met their PRIA due dates or extended due dates. Of those, 18 (22%) were completed within 120 days, and 30 (31%) were completed within 180 days. In FY' 12, the percentages completed within 120 days and 180 days were 45% and 67% respectively. iicide 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. To date 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. The 6(a)(2) data have been migrated into a new system that enables EPA staff to query the database in the manner most relevant to their needs, such as: by location of the incident, by active ingredient, by product name, by registration number, etc. In addition, ecological and pet reporting portals were established through the EPA's cooperative agreement with the National Pesticide Information Center at Oregon State University. Other portals were established specifically for the reporting of bee kills. These portals bolster our data system by collecting detailed information from such sources as states, veterinarians, bee keepers and wildlife rehabilitation facilities. Increasing the availability of incident data to the public is part of a longer-term, ongoing EPA initiative. EPA provides 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/About NAS S/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. Page 9 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 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. 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/pesticide surveys .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 arc 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 arc required to report each pesticide application, at least annually. Oregon - http://www.oregon.gov/ODA/PEST/Pages/purs index.aspx#Annual reports: 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/imperia/md/content/gfkkvnetec/gfk kynetec sigma final 12-3-09.pdf: SIGMA, a subsidiary of GfK Kynetec, is the primary source for international pesticide usage data for Page 10 of 11 ------- Implementing the Pesticide Registration Improvement Act — Fiscal Year 2013 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 plications Penc 1 , Table IV summarizes the pending registration applications (counted as decisions) in each of the PRIA categories as required by FIFRA Section 33(k)(2)(v). As of September 30, 2013, 1102 decisions subject to PRIA were pending in the agency's registration queue. Numbers pending at the end of FY' 12, FY' 11 and FY' 10 are shown for comparison and were, 1143, 1217, and 1151,respectively. The number of antimicrobial decisions pending (136) was lower than at the end of FY' 12, FY'11 and FY 2010 (184, 191 and 201 respectively). The pending number of biopesticide decisions at the end of FY' 13 (135) was greater than that at the end of FY'12 (110). Among conventional pesticide decisions, the number pending at the end of FY'13 (794) was less than at the end of FY' 12 (849) and FY' 11(875). The number of PRIA inert decisions pending at the end of FY' 13 was 22. The number of miscellaneous decisions pending at the end of FY' 13 was 15. Page 11 of 11 ------- |