[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)] [Notices] [Pages 59347-59359] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2013-23368] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2013-0621; FRL-9399-5] Pesticides; Revised Fee Schedule for Registration Applications AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: EPA is publishing a revised list of pesticide registration service fees applicable to specified pesticide applications and tolerance actions. Under the Pesticide Registration Improvement Extension Act, the registration service fees for covered pesticide registration applications received on or after October 1, 2013, increase by 5% rounding up to the nearest dollar from the fees published for fiscal year 2012. The new fees become effective on October 1, 2013. FOR FURTHER INFORMATION CONTACT: Peter Caulkins (7501P), Immediate Office, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-6550; fax number: (703) 308-4776; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you register pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Potentially affected entities may include, but are not limited to:Agricultural pesticide manufacturers (NAICS code 32532). Antimicrobial pesticide manufacturers (NAICS code 32561). Antifoulant pesticide manufacturers (NAICS code 32551). Wood preservative manufacturers (NAICS code 32519). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American [[Page 59348]] Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in the notice and in FIFRA section 33. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How can I get copies of this document and other related information? The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0621, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305- 5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. II. Background A. What action is the Agency taking? The Pesticide Registration Improvement Act of 2003 established a new section 33 of FIFRA creating a registration service fee system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. The Agency began administering the registration service fee system for covered applications received on or after March 23, 2004. On September 28, 2012, the Pesticide Registration Improvement Extension Act was signed by the President, revising, among other things, FIFRA section 33. The new law reauthorized the service fee system through fiscal year 2017 and established fees and review times for applications received during fiscal years 2013 through 2017. As required by section 33(b)(6)(A) of FIFRA, the registration service fees for covered pesticide registration applications received on or after October 1, 2013, increase by 5% rounding up to the nearest dollar from the fees published in the September 28, 2012 Pesticide Registration Improvement Extension Act. B. What is the Agency's authority for taking this action? The publication of this fee schedule is required by section 33(b)(6)(C) of FIFRA as amended. III. Elements of the Fee Schedule This unit explains how to read the fee schedule tables, and includes a key to terminology published with the table. A. The Pesticide Registration Improvement Extension Act Fee Schedule The fee schedule published in the Pesticide Registration Improvement Extension Act of September 28, 2013, identifies the registration service fees and decision times and is organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA. Thereafter, the categories within the organizational unit sections of the table are further categorized according to the type of application being submitted, the use patterns involved, or, in some cases, upon the type of pesticide that is the subject of the application. The fee categories differ by Division. Not all application types are covered by, or subject to, the fee system. B. Fee Schedule and Decision Review Times In today's notice, EPA has retained the format of the tables included in the Pesticide Registration Improvement Extension Act of September 28, 2012. The schedules are presented as 18 tables, organized by OPP Division and by type of application or pesticide subject to the fee. Unit IV. presents fee tables for the Registration Division (RD) (6 tables), the Antimicrobials Division (AD) (4 tables), the Biopesticides and Pollution Prevention Division (BPPD) (7 tables), and Inert Ingredients, External Review and Miscellaneous (1 table). C. How To Read the Tables 1. Each table consists of the following columns: The column titled ``EPA No.''' assigns an EPA identifier to each fee category. There are 189 categories spread across the 3 Divisions. There are 63 RD categories, 39 AD categories, 69 BPPD categories, 10 inert categories, and 8 miscellaneous categories. For tracking purposes, OPP has assigned a 3-digit identifier to each category, beginning with RD categories, followed by AD, BPPD, inert and miscellaneous categories. The categories are prefaced with a letter designation indicating which Division of OPP is responsible for applications in that category (R=Registration Division, A=Antimicrobials Division, B=Biopesticides and Pollution Prevention Division, I=inert ingredients, M= miscellaneous). The column titled ``CR No.'' cross-references the current Congressional Record category number for convenience. However, EPA will be using the categories as numbered in the ``EPA No.'' column in its tracking systems. The column titled ``Action''' describes what registration actions are covered by each category. The column titled ``Decision Time'' lists the decision times in months for each type of action. The column titled ``FY 2014/FY 2015 Registration Service Fee ($)'' lists the registration service fee for the action for fiscal year 2014 (October 1, 2013 through September 30, 2014) and fiscal year 2015 (October 1, 2014 through September 30, 2015). Footnote text has been removed to save on Federal Register costs but remains unchanged from what was published in FY 2013. The tables and footnote text will be available in full after October 1 at http://www.epa.gov/pesticides/regulating/fees/tool/category-table.html. 2. The following acronyms are used in some of the tables: DART-Dose Adequacy Response Team. DNT-Developmental Neurotoxicity. HSRB-Human Studies Review Board. GW/SW-Ground Water/Surface Water. PHI-Pre-Harvest Interval. PPE-Personal Protective Equipment. REI-Restricted Entry Interval. SAP-FIFRA Scientific Advisory Panel. IV. PRIA Fee Schedule Tables--Effective October 1, 2013 A. Registration Division (RD) The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed ``conventional chemicals,'' excluding pesticides intended for antimicrobial uses. The term ``conventional chemical'' is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic [[Page 59349]] origin, synthetic chemicals that are identical to naturally occurring chemicals and microbial pesticides. Tables 1 through 6 cover RD actions. Table 1--Registration Division--New Active Ingredients ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- R010......................... 1 New active ingredient, food use.. 24 597,683 R020......................... 2 New active ingredient, food use; 18 597,683 reduced risk. R040......................... 3 New active ingredient, food use; 18 440,478 Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. R060......................... 4 New active ingredient, non-food 21 415,241 use; outdoor. R070......................... 5 New active ingredient, non-food 16 415,241 use; outdoor; reduced risk. R090......................... 6 New active ingredient, non-food 16 308,276 use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. R110......................... 7 New active ingredient, non-food 20 230,947 use; indoor. R120......................... 8 New active ingredient, non-food 14 230,947 use; indoor; reduced risk. R121......................... 9 New active ingredient, non-food 18 173,644 use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. R122......................... 10 Enriched isomer(s) of registered 18 302,026 mixed-isomer active ingredient. R123......................... 11 New active ingredient, seed 18 449,391 treatment only; includes agricultural and non- agricultural seeds; residues not expected in raw agricultural commodities. R125......................... 12 New active ingredient, seed 16 308,276 treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. ---------------------------------------------------------------------------------------------------------------- Table 2--Registration Division--New Uses ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- R130......................... 13 First food use; indoor; food/food 21 182,327 handling. R140......................... 14 Additional food use; indoor; food/ 15 42,544 food handling. R150......................... 15 First food use................... 21 251,669 R160......................... 16 First food use; reduced risk..... 16 251,669 R170......................... 17 Additional food use.............. 15 62,975 R175......................... 18 Additional food uses covered 10 62,975 within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. R180......................... 19 Additional food use; reduced risk 10 62,975 R190......................... 20 Additional food uses; six or more 15 377,849 submitted in one application. R200......................... 21 Additional food use; six or more 10 377,849 submitted in one application; reduced risk. R210......................... 22 Additional food use; Experimental 12 46,653 Use Permit application; establish temporary tolerance; no credit toward new use registration. R220......................... 23 Additional food use; Experimental 6 18,893 Use Permit application; crop destruct basis; no credit toward new use registration. R230......................... 24 Additional use; non-food; outdoor 15 25,168 R240......................... 25 Additional use; non-food; 10 25,168 outdoor; reduced risk. R250......................... 26 Additional use; non-food; 6 18,893 outdoor; Experimental Use Permit application; no credit toward new use registration. R251......................... 27 Experimental Use Permit 8 18,893 application which requires no changes to the tolerance(s); non- crop destruct basis. R260......................... 28 New use; non-food; indoor........ 12 12,156 R270......................... 29 New use; non-food; indoor; 9 12,156 reduced risk. R271......................... 30 New use; non-food; indoor; 6 9,261 Experimental Use Permit application; no credit toward new use registration. R273......................... 31 Additional use; seed treatment; 12 48,042 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. R274......................... 32 Additional uses; seed treatment 12 288,250 only; six 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. ---------------------------------------------------------------------------------------------------------------- [[Page 59350]] Table 3--Registation Division--Import and Other Tolerances ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- R280......................... 33 Establish import tolerance; new 21 303,878 active ingredient or first food use. R290......................... 34 Establish Import tolerance; 15 60,777 additional new food use. R291......................... 35 Establish import tolerances; 15 364,653 additional food uses; six or more crops submitted in one petition. R292......................... 36 Amend an established tolerance 11 43,181 (e.g., decrease or increase); domestic or import; applicant- initiated. R293......................... 37 Establish tolerance(s) for 12 50,936 inadvertent residues in one crop; applicant-initiated. R294......................... 38 Establish tolerances for 12 305,613 inadvertent residues; six or more crops submitted in one application; applicant-initiated. R295......................... 39 Establish tolerance(s) for 15 62,975 residues in one rotational crop in response to a specific rotational crop application; applicant-initiated. R296......................... 40 Establish tolerances for residues 15 377,849 in rotational crops in response to a specific rotational crop petition; six or more crops submitted in one application; applicant-initiated. R297......................... 41 Amend six or more established 11 259,082 tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant- initiated. R298......................... 42 Amend an established tolerance 13 55,776 (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant- initiated). R299......................... 43 Amend six or more established 13 271,677 tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated). ---------------------------------------------------------------------------------------------------------------- Table 4--Registration Division--New Products ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- R300......................... 44 New product; or similar 4 1,506 combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP--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% repackage of registered end-use or manufacturing-use product that requires no data submission nor data matrix. R301......................... 45 New product; or similar 4 1,806 combination product (already registered) to an 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. R310......................... 46 New end-use or manufacturing-use 7 5,048 product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only: product chemistry and/or acute toxicity and/or... public health pest efficacy and/or. child resistant packaging. R314......................... 47 New end-use product containing 8 6,310 two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: product chemistry and/or acute toxicity and/or... public health pest efficacy and/or. child resistant packaging. [[Page 59351]] R315......................... 48 New end-use non-food animal 9 8,400 product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: product chemistry and/or acute toxicity and/or... public health pest efficacy and/or. animal safety studies and/or. child resistant packaging. R320......................... 49 New product; new physical form; 12 12,596 requires data review in science divisions. R331......................... 50 New product; repack of identical 3 2,409 registered end-use product as a manufacturing-use product; same registered uses only. R332......................... 51 New manufacturing-use product; 24 269,728 registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions. R333......................... 52 New product; MUP or end-use 10 18,893 product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. R334......................... 53 New product; MUP or end-use 11 18,893 product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. ---------------------------------------------------------------------------------------------------------------- Table 5--Registration Division--Amendments to Registration ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- R340......................... 54 Amendment requiring data review 4 3,798 within RD (e.g., changes to precautionary label statements). R345......................... 55 Amending non-food animal product 7 8,400 that includes submission of target animal safety data; previously registered. R350......................... 56 Amendment requiring data review 9 12,596 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). R351......................... 57 Amendment adding a new 8 12,596 unregistered source of active ingredient. R352......................... 58 Amendment adding already approved 8 12,596 uses; selective method of support; does not apply if the applicant owns all cited data. R371......................... 59 Amendment to Experimental Use 6 9,609 Permit; (does not include extending a permit's time period). ---------------------------------------------------------------------------------------------------------------- Table 6--Registration Division--Other Actions ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- R124 60 Conditional ruling on pre- 6 2,409 application study waivers; applicant-initiated. R272 61 Review of study protocol 3 2,409 applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review. R275 62 Rebuttal of agency reviewed 3 2,409 protocol, applicant-initiated. R370 63 Cancer reassessment; applicant- 18 188,809 initiated. ---------------------------------------------------------------------------------------------------------------- B. Antimicrobials Division (AD) The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 7 through 10 cover AD actions. [[Page 59352]] Table 7--Antimicrobials Division--New Active Ingredients ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- A380......................... 64 New active ingredient food use, 24 109,397 establish tolerance exemption. A390......................... 65 New active ingredient food use, 24 182,327 establish tolerance. A400......................... 66 New active ingredient, non-food 18 91,165 use, outdoor, FIFRA section 2(mm) uses. A410......................... 67 New active ingredient non-food 21 182,327 use, outdoor, uses other than FIFRA section 2(mm). A420......................... 68 New active ingredient non-food 18 60,777 use, indoor, FIFRA section 2(mm) uses. A430......................... 69 New active ingredient, non-food 20 91,165 use indoor, uses other than FIFRA section 2(mm) uses. A431......................... 70 New active ingredient, non-food 12 63,670 use; indoor; low-risk; low- toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol. ---------------------------------------------------------------------------------------------------------------- Table 8--Antimicrobials Division--New Uses ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- A440......................... 71 New use, first food use; 21 30,390 establish tolerance exemption. A450......................... 72 New use, first food use; 21 91,165 establish tolerance. A460......................... 73 New use, additional food use; 15 12,156 establish tolerance exemption. A470......................... 74 New use, additional food use; 15 30,390 establish tolerance. A471......................... 75 Additional food uses; establish 15 182,335 tolerances; six or more submitted in one application. A480......................... 76 New use, additional use, non- 9 18,234 food, outdoor; FIFRA section 2(mm) uses. A481......................... 77 Additional non-food outdoor uses; 9 109,400 FIFRA section 2(mm) uses; six or more submitted in one application. A490......................... 78 New use, additional use, non- 15 30,390 food, outdoor, uses other than FIFRA section 2(mm). A491......................... 79 Additional non-food; outdoor; 15 182,335 uses other than FIFRA section 2(mm); six or more submitted in one application. A500......................... 80 New use, additional use, non- 9 12,156 food, indoor FIFRA section 2(mm) uses. A501......................... 81 Additional non-food; indoor; 9 72,936 FIFRA section 2(mm) uses; six or more submitted in one application. A510......................... 82 New use, additional use, non- 12 12,156 food, indoor, other than FIFRA section 2(mm). A511......................... 83 Additional non-food; indoor; uses 12 72,936 other than FIFRA section 2(mm); six or more submitted in one application. ---------------------------------------------------------------------------------------------------------------- Table 9--Antimicrobials Division--New Products and Amendments ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- A530......................... 84 New product, identical or 4 1,217 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. A531......................... 85 New product; identical or 4 1,737 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. A532......................... 86 New product; identical or 5 4,863 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. A540......................... 87 New end-use product; FIFRA 5 4,863 section 2(mm) uses only. A550......................... 88 New end-use product; uses other 7 4,863 than FIFRA section 2(mm); non- FQPA product. A560......................... 89 New manufacturing use product; 12 18,234 registered active ingredient; selective data citation. A570......................... 90 Label amendment requiring data 4 3,648 review. [[Page 59353]] A572......................... 91 New product or amendment 9 12,596 requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate). ---------------------------------------------------------------------------------------------------------------- Table 10--Antimicrobials Division--Experimental Use Permits and Other Type of Actions ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- A520......................... 92 Experimental Use Permit 9 6,079 application. A521......................... 93 Review of public health efficacy 3 2,363 study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1. A522......................... 94 Review of public health efficacy 12 11,577 study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2. A524......................... 95 New active ingredient, 18 145,862 Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. A525......................... 96 New active ingredient, 18 87,774 Experimental Use Permit application; food use requires tolerance exemption. Credit 45% of fee toward new active ingredient application that follows. A526......................... 97 New active ingredient, 15 91,165 Experimental Use Permit application; non-food, outdoor use. Credit 45% of fee toward new active ingredient application that follows. A527......................... 98 New active ingredient, 15 60,900 Experimental Use Permit application; non-food, indoor use. Credit 45% of fee toward new active ingredient application that follows. A528......................... 99 Experimental Use Permit 15 21,273 application, food use; requires tolerance or tolerance exemption. A529......................... 100 Amendment to Experimental Use 9 10,884 Permit; requires data review or risk assessment. A523......................... 101 Review of protocol other than a 9 11,577 public health efficacy study (i.e., toxicology or exposure protocols). A571......................... 102 Science reassessment: Cancer 18 91,165 risk, refined ecological risk, and/or endangered species; applicant-initiated. ---------------------------------------------------------------------------------------------------------------- C. Biopesticides and Pollution Prevention Division (BPPD) The Biopesticides and Pollution Prevention Division of OPP is responsible for the processing of pesticide applications for biochemical pesticides, microbial pesticides, and plant-incorporated protectants (PIPs). The fee tables for BPPD actions are presented by type of pesticide rather than by type of action: Microbial and biochemical pesticides, straight chain lepidopteran pheromones (SCLPs), and PIPs. Within each table, the types of application are the same as those in other divisions. Tables 11 through 17 cover BPPD actions. Table 11--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Active Ingredients ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- B580......................... 103 New active ingredient; food use; 19 48,621 petition to establish a tolerance. B590......................... 104 New active ingredient; food use; 17 30,390 petition to establish a tolerance exemption. B600......................... 105 New active ingredient; non-food 13 18,234 use. B610......................... 106 New active ingredient; 10 12,156 Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption. B611......................... 107 New active ingredient; 12 12,156 Experimental Use Permit application; petition to establish permanent tolerance exemption. B612......................... 108 New active ingredient; no change 10 16,714 to a permanent tolerance exemption. B613......................... 109 New active ingredient; petition 11 16,714 to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption. [[Page 59354]] B620......................... 110 New active ingredient; 7 6,079 Experimental Use Permit application; non-food use including crop destruct. ---------------------------------------------------------------------------------------------------------------- Table 12--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Active Ingredients ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- B630......................... 111 First food use; petition to 13 12,156 establish a tolerance exemption. B631......................... 112 New food use; petition to amend 12 12,156 an established tolerance. B640......................... 113 New food use; petition to amend 19 18,234 an established tolerance. B643......................... 114 New food use; petition to amend 10 12,156 tolerance exemption. B642......................... 115 First food use; indoor; food/food 12 30,390 handling. B644......................... 116 New use, no change to an 8 12,156 established tolerance or tolerance exemption. B650......................... 117 New use; non-food................ 7 6,079 ---------------------------------------------------------------------------------------------------------------- Table 13--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Products ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- B652......................... 118 New product; registered source of 13 12,156 active ingredient; requires petition to amend established tolerance or tolerance exemption; requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. B660......................... 119 New product; registered source of 4 1,217 active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re- isolated. B670......................... 120 New product; registered source of 7 4,863 active ingredient(s); no change in an established tolerance or tolerance exemption; requires: (1) submission of product- specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. B671......................... 121 New product; unregistered source 17 12,156 of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: (1) Submission of product- specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. [[Page 59355]] B672......................... 122 New product; unregistered source 13 8,683 of active ingredient(s); non- food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: (1) submission of product- specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. B673......................... 123 New product MUP/EP; unregistered 10 4,863 source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. B674......................... 124 New product MUP; Repack of 4 1,217 identical registered end-use product as a manufacturing-use product; same registered uses only. B675......................... 125 New product MUP; registered 10 8,683 source of active ingredient; submission of completely new generic data package; registered uses only. B676......................... 126 New product; more than one active 13 8,683 ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: (1) Submission of product-specific data, and (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. B677......................... 127 New end-use non-food animal 10 8,400 product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: product chemistry and/or acute toxicity and/or... public health pest efficacy and/or. animal safety studies and/or. child resistant packaging. ---------------------------------------------------------------------------------------------------------------- Table 14--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; Amendments ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- B621......................... 128 Amendment; Experimental Use 7 4,863 Permit; no change to an established temporary tolerance or tolerance exemption. B622......................... 129 Amendment; Experimental Use 11 12,156 Permit; petition to amend an established or temporary tolerance or tolerance exemption. B641......................... 130 Amendment of an established 13 12,156 tolerance or tolerance exemption. B680......................... 131 Amendment; registered source of 5 4,863 active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. B681......................... 132 Amendment; unregistered source of 7 5,789 active ingredient(s). Requires data submission. B683......................... 133 Label amendment; requires review/ 6 4,863 update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). B684......................... 134 Amending non-food animal product 8 8,400 that includes submission of target animal safety data; previously registered. ---------------------------------------------------------------------------------------------------------------- [[Page 59356]] Table 15--Biopesticides and Pollution Prevention Division--Straight Chain Lepidopteran Pheromones (SCLPS) ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- B690......................... 135 New active ingredient; food or 7 2,432 non-food use. B700......................... 136 Experimental Use Permit 7 1,217 application; new active ingredient or new use. B701......................... 137 Extend or amend Experimental Use 4 1,217 Permit. B710......................... 138 New product; registered source of 4 1,217 active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. B720......................... 139 New product; registered source of 5 1,217 active ingredient(s); requires: (1) submission of product- specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. B721......................... 140 New product; unregistered source 7 2,548 of active ingredient. B722......................... 141 New use and/or amendment; 7 2,359 petition to establish a tolerance or tolerance exemption. B730......................... 142 Label amendment requiring data 5 1,217 submission. ---------------------------------------------------------------------------------------------------------------- Table 16--Biopesticides and Pollution Prevention Division--Other Actions ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- B614......................... 143 Conditional ruling on pre- 3 2,409 application study waivers; applicant-initiated. B615......................... 144 Rebuttal of agency reviewed 3 2,409 protocol, applicant-initiated. B682......................... 145 Protocol review; applicant- 3 2,316 initiated; excludes time for HSRB review. ---------------------------------------------------------------------------------------------------------------- Table 17--Biopesticides and Pollution Prevention Division--Plant Incorporated Protectants (PIPS) ---------------------------------------------------------------------------------------------------------------- FY '14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- B740......................... 146 Experimental Use Permit 6 91,165 application; no petition for tolerance/tolerance exemption. Includes: 1. non-food/feed use(s) for a new or registered PIP;. 2. food/feed use(s) for a new or registered PIP with crop destruct;. 3. food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). B750......................... 147 Experimental Use Permit 9 121,552 application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/ feed use for a registered PIP. B770......................... 148 Experimental Use Permit 15 182,327 application; new PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. B771......................... 149 Experimental Use Permit 10 121,552 application; new PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows. B772......................... 150 Application to amend or extend an 3 12,156 Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. B773......................... 151 Application to amend or extend an 5 30,390 Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. B780......................... 152 Registration application; new 12 151,940 PIP; non-food/feed. [[Page 59357]] B790......................... 153 Registration application; new 18 212,715 PIP; non-food/feed; SAP review. B800......................... 154 Registration application; new 12 243,165 PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. B810......................... 155 Registration application; new 18 303,878 PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. B820......................... 156 Registration application; new 15 303,878 PIP; with petition to establish or amend a permanent tolerance/ tolerance exemption of an active ingredient. B840......................... 157 Registration application; new 21 364,653 PIP; with petition to establish or amend a permanent tolerance/ tolerance exemption of an active ingredient. SAP review. B851......................... 158 Registration application; new 9 121,552 event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). B870......................... 159 Registration application; 9 36,466 registered PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). B880......................... 160 Registration application; 9 30,390 registered PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). B881......................... 161 Registration application; 15 91,165 registered PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). SAP review. B883......................... 162 Registration application; new 9 121,552 PIP, seed increase with negotiated acreage cap and time- limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. B884......................... 163 Registration application; new 12 151,940 PIP, seed increase with negotiated acreage cap and time- limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. B885......................... 164 Registration application; 9 91,165 registered PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). B890......................... 165 Application to amend a seed 9 60,777 increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). B891......................... 166 Application to amend a seed 15 121,552 increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s), SAP review. B900......................... 167 Application to amend a 6 12,156 registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. B901......................... 168 Application to amend a 12 72,931 registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. B902......................... 169 PIP Protocol review.............. 3 6,079 B903......................... 170 Inert ingredient tolerance 6 60,777 exemption; e.g., a marker such as NPT II; reviewed in BPPD. B904......................... 171 Import tolerance or tolerance 9 121,552 exemption; processed commodities/ food only (inert or active ingredient). ---------------------------------------------------------------------------------------------------------------- Table 18--Inert Ingredients, External Review and Miscellaneous Actions ---------------------------------------------------------------------------------------------------------------- FY'14/15 Decision registration EPA No. New CR No. Action review time service fee (months) ($) ---------------------------------------------------------------------------------------------------------------- I001......................... 172 Approval of new food use inert 12 18,900 ingredient. I002......................... 173 Amend currently approved inert 10 5,250 ingredient tolerance or exemption from tolerance; new data. I003......................... 174 Amend currently approved inert 8 3,150 ingredient tolerance or exemption from tolerance; no new data. I004......................... 175 Approval of new non-food use 8 10,500 inert ingredient. [[Page 59358]] I005......................... 176 Amend currently approved non-food 8 5,250 use inert ingredient with new use pattern; new data. I006......................... 177 Amend currently approved non-food 6 3,150 use inert ingredient with new use pattern; no new data. I007......................... 178 Approval of substantially similar 4 1,575 non-food use inert ingredients when original inert is compositionally similar with similar use pattern. I008......................... 179 Approval of new polymer inert 5 3,570 ingredient, food use. I009......................... 180 Approval of new polymer inert 4 2,940 ingredient, non-food use. I010......................... 181 Petition to amend a tolerance 6 1,575 exemption descriptor to add one or more CASRNs; no new data. M001......................... 182 Study protocol requiring Human 9 7,560 Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient. M002......................... 183 Completed study requiring Human 9 7,560 Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient. M003......................... 184 External technical peer review of 12 60,900 new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant-initiated request based on a requirement of the Administrator, as defined by FIFRA section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. M004......................... 185 External technical peer review of 18 60,900 new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant- initiated request based on a requirement of the Administrator, as defined by FIFRA section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. M005......................... 186 New product: combination, 9 21,000 contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/ or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. M006......................... 187 Request for up to 5 letters of 1 263 certification (Gold Seal) for one actively registered product. M007......................... 188 Request to extend Exclusive Use 12 5,250 of data as provided by FIFRA section 3(c)(1)(F)(ii). M008......................... 189 Request to grant Exclusive Use of 10 1,575 data as provided by FIFRA section 3(c)(1)(F)(vi) for a minor use, when a FIFRA section 2(ll)(2) determination is required. ---------------------------------------------------------------------------------------------------------------- V. How to Pay Fees Applicants must submit fee payments at the time of application, and EPA will reject any application that does not contain evidence that the fee has been paid. EPA has developed a Web site at http://www.epa.gov/pesticides/fees/tool/index.htm to help applicants identify the fee category and the fee. All fees should be rounded up to the whole dollar. Payments may be made by check, bank draft, or money order or online with a credit card or wire transfer. A. Online You may pay electronically through the government payment Web site www.pay.gov. 1. From the pay.gov home page, under ``Find Public Forms.'' 2. Select ``search by Agency name.'' 3. On the A-Z Index of Forms page, select ``E.'' 4. Select ``Environmental Protection Agency.'' 5. From the list of forms, select ``Pre-payment of Pesticide Registration Improvement Act Fee.'' 6. Complete the form entering the PRIA fee category and fee. 7. Keep a copy of the pay.gov acknowledgement of payment. A copy of the acknowledgement must be printed and attached to the front of the application to assure that EPA can match the application with the payment. B. By Check or Money Order All payments must be in United States currency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency. On the check, the applicant must supply in the information line either the registration number of the product or the company number. A copy of the check must accompany the application to the Agency, specifically attached to the front of the application. The copy of the check ensures that payment has been made at the time of application and will enable the Agency to properly connect the payment with the application sent to the Agency. If you send the Agency a check, it will be converted into an electronic funds transfer (EFT). This means the Agency will copy your check and use the account information on it to electronically debit your account for the amount of the check. The debit from your account will usually occur within 24 hours and will be shown on your regular account statement. You will not receive your original check back. The Agency will destroy your original check but will keep the copy of it. If the EFT cannot be processed for technical reasons, you authorize the Agency to process the copy in place of your original check. If [[Page 59359]] the EFT cannot be completed because of insufficient funds, the Agency may try to make the transfer up to two times. All paper-based payments should be sent to the following address: By U.S. Postal Service. U.S. Environmental Protection Agency, Washington Finance Center, FIFRA Service Fees, P.O. Box 979074, St. Louis, MO 63197-9000. By courier or personal delivery. U.S. Bank, Government Lockbox 979074, 1005 Convention Plaza, SL-MO-C2-GL, St. Louis, MO 63197, (314) 418-4990. VI. How to Submit Applications Submissions to the Agency should be made at the address given in Unit VII. The applicant should attach documentation that the fee has been paid which may be pay.gov payment acknowledgement or a copy of the check. If the applicant is applying for a fee waiver, the applicant should provide sufficient documentation as described in FIFRA section 33(b)(7) and http://www.epa.gov/pesticides/fees/questions/waivers.htm. The fee waiver request should be easy to identify and separate from the rest of the application and submitted with documentation that at least 25% of the fee has been paid. If evidence of fee payment (electronic acknowledgement or copy of check properly identified as to company) is not submitted with the application, EPA will reject the application and will not process it further. After EPA receives an application and payment, EPA performs a screen on the application to determine that the category is correct and that the proper fee amount has been paid. If either is incorrect, EPA will notify the applicant and require payment of any additional amount due. A refund will be provided in case of an overpayment. EPA will not process the application further until the proper fee has been paid for the category of application or a request for a fee waiver accompanies the application and the appropriate portion of the fee has been paid. EPA will assign a unique identification number to each covered application for which payment has been made. EPA notifies the applicant of the unique identification number. This information is sent by email if EPA has either an email address on file or an email address is provided on the application. VII. Addresses for Applications New covered applications should be identified in the title line with the mail code REGFEE. By U.S. Postal Service mail. Document Processing Desk (REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460- 0001. By courier. Document Processing Desk (REGFEE), Office of Pesticide Programs, U.S. Environmental Protection Agency, Room S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA 22202-4501. Couriers and delivery personnel must present a valid picture identification card to gain access to the building. Hours of operation for the Document Processing Desk are 8 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. List of Subjects Environmental protection, Administrative practice and procedure, Pesticides. Dated: September 18, 2013. Martha Monell, Acting Director, Office of Pesticide Programs. [FR Doc. 2013-23368 Filed 9-25-13; 8:45 am] BILLING CODE 6560-50-P