Notices. Notice
7,163 words·~33 min read·
/register/2015/09/22/2015-24064·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6717-01-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0614; FRL-9933-75] 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, 2015, increase by 5% rounding up to the nearest dollar from the fees published for fiscal year 2015.
The new fees for FY'2016 become effective on October 1, 2015. 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: *caulkins.peter@epa.gov.* 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 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-2015-0614, 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, 2015, increase by 5% rounding up to the nearest dollar from the fees published in the September 26, 2013, “Pesticides: Fee Schedule for Registration Applications,” FRN Vol. 78. No. 187 pp. 59347-59359. 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, 2012, 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 19 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), Inert Ingredients (1 table), 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' 2016/17 Registration Service Fee ($)” lists the registration service fee for the action for fiscal year 2016 (October 1, 2015 through September 30, 2016) and fiscal year 2017 (October 1, 2016 through September 30, 2017). • Footnote text has been removed to save on **Federal Register** costs but remains unchanged from what was published in FY' 2013. The tables and footnote text will be available in full after October 1, 2015 at *http://www.epa.gov/pesticides/regulating/fees/tool/category-table.html.* 2. *The following acronyms are used in some of the tables:* • DART—Dose Adequacy Response Team. • DNT—Developmental Neurotoxicity. • HSRB—Human Studies Review Board. • GW/SW—Ground Water/Surface Water. • PHI-Pre—Harvest Interval. • PPE—Personal Protective Equipment. • REI—Restricted Entry Interval. • SAP—FIFRA Scientific Advisory Panel. IV. PRIA Fee Schedule Tables—Effective October 1, 2015 A. Registration Division
(RD)The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed “conventional chemicals,” excluding pesticides intended for antimicrobial uses. The term “conventional chemical” is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic origin, synthetic chemicals that are identical to naturally occurring chemicals and microbial pesticides. Tables 1 through 6 cover RD actions. Table 1—Registration Division—New Active Ingredients EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) R010 1 New Active Ingredient, Food use 24 627,568 R020 2 New Active Ingredient, Food use; reduced risk 18 627,568 R040 3 New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows 18 462,502 R060 4 New Active Ingredient, Non-food use; outdoor 21 436,004 R070 5 New Active Ingredient, Non-food use; outdoor; reduced risk 16 436,004 R090 6 New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows 16 323,690 R110 7 New Active Ingredient, Non-food use; indoor 20 242,495 R120 8 New Active Ingredient, Non-food use; indoor; reduced risk 14 242,495 R121 9 New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows 18 182,327 R122 10 Enriched isomer(s) of registered mixed-isomer active ingredient 18 317,128 R123 11 New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities 18 471,861 R125 12 New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows 16 323,690 Table 2—Registration Division—New Uses EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) R130 13 First food use; indoor; food/food handling 21 191,444 R140 14 Additional food use; Indoor; food/food handling 15 44,672 R150 15 First food use 21 264,253 R160 16 First food use; reduced risk 16 264,253 R170 17 Additional food use 15 66,124 R175 18 Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. 10 66,124 R180 19 Additional food use; reduced risk 10 66,124 R190 20 Additional food uses; 6 or more submitted in one application 15 396,742 R200 21 Additional food use; 6 or more submitted in one application; reduced risk 10 396,742 R210 22 Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration 12 48,986 R220 23 Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration 6 19,838 R230 24 Additional use; non-food; outdoor 15 26,427 R240 25 Additional use; non-food; outdoor; reduced risk 10 26,427 R250 26 Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration 6 19,838 R251 27 Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis 8 19,838 R260 28 New use; non-food; indoor 12 12,764 R270 29 New use; non-food; indoor; reduced risk 9 12,764 R271 30 New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration 6 9,725 R273 31 Additional use; seed treatment; 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 12 50,445 R274 32 Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses 12 302,663 Table 3—Registration Division—Import and Other Tolerances EPA No. New CR No. Action Decision review time (months) FY '16/17— registration service fee ($) R280 33 Establish import tolerance; new active ingredient or first food use 21 319,072 R290 34 Establish Import tolerance; Additional new food use 15 63,816 R291 35 Establish import tolerances; additional food uses; 6 or more crops submitted in one petition 15 382,886 R292 36 Amend an established tolerance ( *e.g.,* decrease or increase); domestic or import; applicant-initiated 11 45,341 R293 37 Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated 12 53,483 R294 38 Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated 12 320,894 R295 39 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 15 66,124 R296 40 Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated 15 396,742 R297 41 Amend 6 or more established tolerances ( *e.g.,* decrease or increase) in one petition; domestic or import; applicant-initiated 11 272,037 R298 42 Amend an established tolerance ( *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) 13 58,565 R299 43 Amend 6 or more established 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) 13 285,261 Table 4—Registration Division—New Products EPA No. New CR No. Action Decision review time (months) FY'16/17 registration service fee ($) R300 44 New product; or similar 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% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix 4 1,582 R301 45 New product; or similar 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 4 1,897 R310 46 New end-use or manufacturing-use 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 7 5,301 R314 47 New end use product containing 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 8 6,626 R315 48 New end-use non-food animal 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 9 8,820 R320 49 New product; new physical form; requires data review in science divisions 12 13,226 R331 50 New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only 3 2,530 R332 51 New manufacturing-use product; 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 24 283,215 R333 52 New product; MUP or End use 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 10 19,838 R334 53 New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc Selective data citation 11 19,838 Table 5—Registration Division—Amendments to Registration EPA No. New CR No. Action Decision review time (months) FY'16/17 registration service fee ($) R340 54 Amendment requiring data review within RD ( *e.g.,* changes to precautionary label statements) 4 3,988 R345 55 Amending non-food animal product that includes submission of target animal safety data; previously registered 7 8,820 R350 56 Amendment requiring data review in science divisions ( *e.g.,* changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement) 9 13,226 R351 57 Amendment adding a new unregistered source of active ingredient 8 13,226 R352 58 Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data 8 13,226 R371 59 Amendment to Experimental Use Permit; (does not include extending a permit's time period) 6 10,090 Table 6—Registration Division—Other Actions EPA No. New CR No. Action Decision review time (Months) FY'16/17 registration service fee ($) R124 60 Conditional Ruling on Preapplication Study Waivers; applicant-initiated 6 2,530 R272 61 Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review 3 2,530 R275 62 Rebuttal of agency reviewed protocol, applicant initiated 3 2,530 R370 63 Cancer reassessment; applicant-initiated 18 198,250 B. Antimicrobials Division
(AD)The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2 (mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 7 through 10 cover AD actions. Table 7—Antimicrobials Division—New Active Ingredients EPA No. New CR No. Action Decision review time (Months) FY'16/17 registration service fee ($) A380 64 New Active Ingredient Food use, establish tolerance exemption 24 114,867 A390 65 New Active Ingredient Food use, establish tolerance 24 191,444 A400 66 New Active Ingredient, Non-food use, outdoor, FIFRA § 2
(mm)uses 18 95,724 A410 67 New Active Ingredient Non-food use, outdoor, uses other than FIFRA § 2(mm) 21 191,444 A420 68 New Active Ingredient Non-food use, indoor, FIFRA § 2(mm) uses 18 63,816 A430 69 New Active Ingredient, Non-Food Use Indoor, uses other than FIFRA § 2(mm) uses 20 95,724 A431 70 New Active Ingredient, Non-food 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 12 66,854 Table 8—Antimicrobials Division—New Uses EPA No. New CR No. Action Decision review time (Months) FY'16/17 registration service fee ($) A440 71 New Use, First Food Use, establish tolerance exemption 21 31,910 A450 72 New use, First food use, establish tolerance 21 95,724 A460 73 New use, additional food use; establish tolerance exemption 15 12,764 A470 74 New use, additional food use, establish tolerance 15 31,910 A471 75 Additional food uses; establish tolerances; 6 or more submitted in one application 15 191,452 A480 76 New use, Additional use, non-food, outdoor; FIFRA § 2(mm) uses 9 19,146 A481 77 Additional non-food outdoor uses; FIFRA § 2(mm) uses; 6 or more submitted in one application 9 114,870 A490 78 New use, additional use, non-food, outdoor, uses other than FIFRA § 2(mm) 15 31,910 A491 79 Additional non-food; outdoor; uses other than FIFRA § 2(mm); 6 or more submitted in one application 15 191,452 A500 80 New use, additional use, non-food, indoor FIFRA § 2(mm) uses 9 12,764 A501 81 Additional non-food; indoor; FIFRA § 2(mm) uses; 6 or more submitted in one application 9 76,583 A510 82 New use, additional use, non-food, indoor, other than FIFRA § 2(mm) 12 12,764 A511 83 Additional non-food; indoor; uses other than FIFRA § 2(mm); 6 or more submitted in one application 12 76,583 Table 9—Antimicrobials Division-New Products and Amendments EPA No. New CR No. Action Decision review time (Months) FY'16/17 registration service fee ($) A530 84 New product, identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite all data citation or selective data citation where applicant owns all required data; or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing use product that requires no data submission nor data matrix 4 1,278 A531 85 New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: Selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner 4 1,824 A532 86 New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted 5 5,107 A540 87 New end use product; FIFRA § 2(mm) uses only
(3)5 5,107 A550 88 New end-use product; uses other than FIFRA § 2(mm); non-FQPA product 7 5,107 A560 89 New manufacturing use product; registered active ingredient; selective data citation 12 19,146 A570 90 Label amendment requiring data review 4 3,831 A572 91 New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate) 9 13,226 Table 10—Antimicrobials Division—Experimental Use Permits and Other Type of Actions EPA No. New CR No. Action Decision review time (Months) FY'16/17 registration service fee ($) A520 92 Experimental Use Permit application, non-food use 9 6,383 A521 93 Review of public health efficacy 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 3 2,482 A522 94 Review of public health efficacy 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. 12 12,156 A523 101 Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols) 9 12,156 A524 95 New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows 18 153,156 A525 96 New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows 18 92,163 A526 97 New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows 15 95,724 A527 98 New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows 15 63,945 A528 99 Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption 15 22,337 A529 100 Amendment to Experimental Use Permit; requires data review or risk assessment 9 11,429 A571 102 Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated 18 95,724 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 EPA No. New CR No. Action Decision review time (months) FY'16/17 registration service fee ($) B580 103 New active ingredient; food use; petition to establish a tolerance 19 51,053 B590 104 New active ingredient; food use; petition to establish a tolerance exemption 17 31,910 B600 105 New active ingredient; non-food use 13 19,146 B610 106 New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption 10 12,764 B611 107 New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption 12 12,764 B612 108 New active ingredient; no change to a permanent tolerance exemption 10 17,550 B613 109 New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption 11 17,550 B620 110 New active ingredient; Experimental Use Permit application; non-food use including crop destruct 7 6,383 Table 12—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Uses EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) B630 111 First food use; petition to establish a tolerance exemption 13 12,764 B631 112 New food use; petition to amend an established tolerance 12 12,764 B640 113 New food use; petition to amend an established tolerance 19 19,146 B642 115 First food use; indoor; food/food handling 12 31,910 B643 114 New Food use; petition to amend tolerance exemption 10 12,764 B644 116 New use, no change to an established tolerance or tolerance exemption 8 12,764 B650 117 New use; non-food 7 6,383 Table 13—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Products EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) B652 118 New product; registered source of 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 13 12,764 B660 119 New product; registered source of 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 4 1,278 B670 120 New product; registered source of 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 7 5,107 B671 121 New product; unregistered source 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 17 12,764 B672 122 New product; unregistered source 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 13 9,118 B673 123 New product MUP/EP; unregistered 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 10 5,107 B674 124 New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only 4 1,278 B675 125 New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only 10 9,118 B676 126 New product; more than one active 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 13 9,118 B677 127 New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data 10 8,820 Table 14—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; Amendments EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) B621 128 Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption 7 5,107 B622 129 Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption 11 12,764 B641 130 Amendment of an established tolerance or tolerance exemption 13 12,764 B680 131 Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption Requires data submission 5 5,107 B681 132 Amendment; unregistered source of active ingredient(s) Requires data submission 7 6,079 B683 133 Label amendment; requires review/update of previous risk assessment(s) without data submission ( *eg.,* labeling changes to REI, PPE, PHI) 6 5,107 B684 134 Amending non-food animal product that includes submission of target animal safety data; previously registered 8 8,820 Table 15—Biopesticides and Pollution Prevention Division—Straight Chain Lepidopteran Pheromones (SCLPS) EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) B690 135 New active ingredient; food or non-food use 7 2,554 B700 136 Experimental Use Permit application; new active ingredient or new use 7 1,278 B701 137 Extend or amend Experimental Use Permit 4 1,278 B710 138 New product; registered source of 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 4 1,278 B720 139 New product; registered source of 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 5 1,278 B721 140 New product; unregistered source of active ingredient 7 2,676 B722 141 New use and/or amendment; petition to establish a tolerance or tolerance exemption 7 2,477 B730 142 Label amendment requiring data submission 5 1,278 Table 16—Biopesticides and Pollution Prevention Division—Other Actions EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) B614 143 Conditional Ruling on Preapplication Study Waivers; applicant-initiated 3 2,530 B615 144 Rebuttal of agency reviewed protocol, applicant initiated 3 2,530 B682 145 Protocol review; applicant initiated; excludes time for HSRB review 3 2,432 Table 17—Biopesticides and Pollution Prevention Division—Plant Incorporated Protectants
(PIPS)EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) B740 146 Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: Non-food/feed use(s) for a new or registered PIP; food/feed use(s) for a new or registered PIP with crop destruct; food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s) 6 95,724 B750 147 Experimental Use Permit 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 9 127,630 B770 148 Experimental Use Permit 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 15 191,444 B771 149 Experimental Use Permit 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 10 127,630 B772 150 Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected 3 12,764 B773 151 Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient 5 31,910 B780 152 Registration application; new PIP; non-food/feed 12 159,537 B790 153 Registration application; new PIP; non-food/feed; SAP review 18 223,351 B800 154 Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption 12 255,324 B810 155 Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review 18 319,072 B820 156 Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient 15 319,072 B840 157 Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review 21 382,886 B851 158 Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s) 9 127,630 B870 159 Registration application; registered PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s) 9 38,290 B880 160 Registration application; 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) 9 31,910 B881 161 Registration application; 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 15 95,724 B883 162 Registration application; new 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 9 127,630 B884 163 Registration application; new PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient 12 159,537 B885 164 Registration application; 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) 9 95,724 B890 165 Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s) 9 63,816 B891 166 Application to amend a seed 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 15 127,630 B900 167 Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled 6 12,764 B901 168 Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review 12 76,578 B902 169 PIP Protocol review 3 6,383 B903 170 Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD 6 63,816 B904 171 Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient) 9 127,630 Table 18—Inert Ingredients EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) I001 172 Approval of new food use inert ingredient 12 19,845 I002 173 Amend currently approved inert ingredient tolerance or exemption from tolerance; new data 10 5,513 I003 174 Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data 8 3,308 I004 175 Approval of new non-food use inert ingredient 8 11,025 I005 176 Amend currently approved non-food use inert ingredient with new use pattern; new data 8 5,513 I006 177 Amend currently approved non-food use inert ingredient with new use pattern; no new data 6 3,308 I007 178 Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern 4 1,654 I008 179 Approval of new polymer inert ingredient, food use 5 3,749 I009 180 Approval of new polymer inert ingredient, non food use 4 3,087 I010 181 Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data 6 1,654 Table 19—Miscellaneous Actions EPA No. New CR No. Action Decision review time (months) FY '16/17 registration service fee ($) M001 182 Study protocol requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient 9 7,938 M002 183 Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient 9 7,938 M003 184 External technical peer review of 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 § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients 12 63,945 M004 185 External technical peer review of 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 § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients 18 63,945 M005 186 New Product: Combination, 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 9 22,050 M006 187 Request for up to 5 letters of certification (Gold Seal) for one actively registered product 1 277 M007 188 Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii) 12 5,513 M008 189 Request to grant Exclusive Use of 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 10 1,654 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. Due to changes mandated by the U.S. Department of the Treasury, checks, bank drafts and money orders are no longer acceptable as of September 30, 2015. Credit card payments are only acceptable for amounts less than or equal to $25,000. All payments above $25,000 can be made by electronic funds transfer via *www.pay.gov.* 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. 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 in most cases will be pay.gov payment acknowledgement. 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) 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 15, 2015. Marty Monell, Acting Director, Office of Pesticide Programs. [FR Doc. 2015-24064 Filed 9-21-15; 8:45 am]
Connections1 off-index
1 reference not yet in our index
- 40 CFR 26
Citation graph
cites case law
Notices
Notice
Cite40 CFR 26
Cites 1Cited by 0 across 0 sources