78 FR 187 pgs. 59347-59359 - Pesticides; Revised Fee Schedule for Registration Applications
Type: NOTICEVolume: 78Number: 187Pages: 59347 - 59359
Pages: 59347, 59348, 59349, 59350, 59351, 59352, 59353, 59354, 59355, 59356, 59357, 59358, 59359Docket number: [EPA-HQ-OPP-2013-0621; FRL-9399-5]
FR document: [FR Doc. 2013-23368 Filed 9-25-13; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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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: 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).
[top] 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
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 ($)" lists the registration service fee for the action for fiscal year 2014 (October 1, 2013 through September 30, 2014) and fiscal year 2015 (October 1, 2014 through September 30, 2015).
• Footnote text has been removed to save on Federal Register costs but remains unchanged from what was published in FY 2013. The tables and footnote text will be available in full after October 1 at http://www.epa.gov/pesticides/regulating/fees/tool/category-table.html.
2. The following acronyms are used in some of the tables:
• DART-Dose Adequacy Response Team.
• DNT-Developmental Neurotoxicity.
• HSRB-Human Studies Review Board.
• GW/SW-Ground Water/Surface Water.
• PHI-Pre-Harvest Interval.
• PPE-Personal Protective Equipment.
• REI-Restricted Entry Interval.
• SAP-FIFRA Scientific Advisory Panel.
IV. PRIA Fee Schedule Tables-Effective October 1, 2013
A. Registration Division (RD)
[top] The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed "conventional chemicals," excluding pesticides intended for antimicrobial uses. The term "conventional chemical" is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| R010 | 1 | New active ingredient, food use | 24 | 597,683 |
| R020 | 2 | New active ingredient, food use; reduced risk | 18 | 597,683 |
| 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 | 440,478 |
| R060 | 4 | New active ingredient, non-food use; outdoor | 21 | 415,241 |
| R070 | 5 | New active ingredient, non-food use; outdoor; reduced risk | 16 | 415,241 |
| 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 | 308,276 |
| R110 | 7 | New active ingredient, non-food use; indoor | 20 | 230,947 |
| R120 | 8 | New active ingredient, non-food use; indoor; reduced risk | 14 | 230,947 |
| 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 | 173,644 |
| R122 | 10 | Enriched isomer(s) of registered mixed-isomer active ingredient | 18 | 302,026 |
| R123 | 11 | New active ingredient, seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities | 18 | 449,391 |
| 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 | 308,276 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| R130 | 13 | First food use; indoor; food/food handling | 21 | 182,327 |
| R140 | 14 | Additional food use; indoor; food/food handling | 15 | 42,544 |
| 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 within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups | 10 | 62,975 |
| R180 | 19 | Additional food use; reduced risk | 10 | 62,975 |
| R190 | 20 | Additional food uses; six or more submitted in one application | 15 | 377,849 |
| R200 | 21 | Additional food use; six or more submitted in one application; reduced risk | 10 | 377,849 |
| R210 | 22 | Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration | 12 | 46,653 |
| R220 | 23 | Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration | 6 | 18,893 |
| R230 | 24 | Additional use; non-food; outdoor | 15 | 25,168 |
| R240 | 25 | Additional use; non-food; outdoor; reduced risk | 10 | 25,168 |
| R250 | 26 | Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration | 6 | 18,893 |
| R251 | 27 | Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis | 8 | 18,893 |
| R260 | 28 | New use; non-food; indoor | 12 | 12,156 |
| R270 | 29 | New use; non-food; indoor; reduced risk | 9 | 12,156 |
| R271 | 30 | New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration | 6 | 9,261 |
| 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 | 48,042 |
| R274 | 32 | Additional uses; seed treatment 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 | 12 | 288,250 |
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| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| R280 | 33 | Establish import tolerance; new active ingredient or first food use | 21 | 303,878 |
| R290 | 34 | Establish Import tolerance; additional new food use | 15 | 60,777 |
| R291 | 35 | Establish import tolerances; additional food uses; six or more crops submitted in one petition | 15 | 364,653 |
| R292 | 36 | Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated | 11 | 43,181 |
| R293 | 37 | Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated | 12 | 50,936 |
| R294 | 38 | Establish tolerances for inadvertent residues; six or more crops submitted in one application; applicant-initiated | 12 | 305,613 |
| R295 | 39 | Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated | 15 | 62,975 |
| R296 | 40 | Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; six or more crops submitted in one application; applicant-initiated | 15 | 377,849 |
| R297 | 41 | Amend six or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated | 11 | 259,082 |
| 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 | 55,776 |
| R299 | 43 | Amend six 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 | 271,677 |
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| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 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% repackage of registered end-use or manufacturing-use product that requires no data submission nor data matrix | 4 | 1,506 |
| 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 | 1,806 |
| 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 | 5,048 |
| 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 | 6,310 |
| 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 | 8,400 |
| R320 | 49 | New product; new physical form; requires data review in science divisions | 12 | 12,596 |
| R331 | 50 | New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only | 3 | 2,409 |
| 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 | 269,728 |
| 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 | 18,893 |
| 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 | 18,893 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| R340 | 54 | Amendment requiring data review within RD (e.g., changes to precautionary label statements) | 4 | 3,798 |
| R345 | 55 | Amending non-food animal product that includes submission of target animal safety data; previously registered | 7 | 8,400 |
| 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 | 12,596 |
| R351 | 57 | Amendment adding a new unregistered source of active ingredient | 8 | 12,596 |
| R352 | 58 | Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data | 8 | 12,596 |
| R371 | 59 | Amendment to Experimental Use Permit; (does not include extending a permit's time period) | 6 | 9,609 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| R124 | 60 | Conditional ruling on pre-application study waivers; applicant-initiated | 6 | 2,409 |
| R272 | 61 | Review of study protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review | 3 | 2,409 |
| R275 | 62 | Rebuttal of agency reviewed protocol, applicant-initiated | 3 | 2,409 |
| R370 | 63 | Cancer reassessment; applicant-initiated | 18 | 188,809 |
B. Antimicrobials Division (AD)
[top] The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 7 through 10 cover AD actions.
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| A380 | 64 | New active ingredient food use, establish tolerance exemption | 24 | 109,397 |
| A390 | 65 | New active ingredient food use, establish tolerance | 24 | 182,327 |
| A400 | 66 | New active ingredient, non-food use, outdoor, FIFRA section 2(mm) uses | 18 | 91,165 |
| A410 | 67 | New active ingredient non-food use, outdoor, uses other than FIFRA section 2(mm) | 21 | 182,327 |
| A420 | 68 | New active ingredient non-food use, indoor, FIFRA section 2(mm) uses | 18 | 60,777 |
| A430 | 69 | New active ingredient, non-food use indoor, uses other than FIFRA section 2(mm) uses | 20 | 91,165 |
| 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 | 63,670 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| A440 | 71 | New use, first food use; establish tolerance exemption | 21 | 30,390 |
| A450 | 72 | New use, first food use; establish tolerance | 21 | 91,165 |
| A460 | 73 | New use, additional food use; establish tolerance exemption | 15 | 12,156 |
| A470 | 74 | New use, additional food use; establish tolerance | 15 | 30,390 |
| A471 | 75 | Additional food uses; establish tolerances; six or more submitted in one application | 15 | 182,335 |
| A480 | 76 | New use, additional use, non-food, outdoor; FIFRA section 2(mm) uses | 9 | 18,234 |
| A481 | 77 | Additional non-food outdoor uses; FIFRA section 2(mm) uses; six or more submitted in one application | 9 | 109,400 |
| A490 | 78 | New use, additional use, non-food, outdoor, uses other than FIFRA section 2(mm) | 15 | 30,390 |
| A491 | 79 | Additional non-food; outdoor; uses other than FIFRA section 2(mm); six or more submitted in one application | 15 | 182,335 |
| A500 | 80 | New use, additional use, non-food, indoor FIFRA section 2(mm) uses | 9 | 12,156 |
| A501 | 81 | Additional non-food; indoor; FIFRA section 2(mm) uses; six or more submitted in one application | 9 | 72,936 |
| A510 | 82 | New use, additional use, non-food, indoor, other than FIFRA section 2(mm) | 12 | 12,156 |
| A511 | 83 | Additional non-food; indoor; uses other than FIFRA section 2(mm); six or more submitted in one application | 12 | 72,936 |
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| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| 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 | 1,217 |
| 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 | 1,737 |
| 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 | 4,863 |
| A540 | 87 | New end-use product; FIFRA section 2(mm) uses only | 5 | 4,863 |
| A550 | 88 | New end-use product; uses other than FIFRA section 2(mm); non-FQPA product | 7 | 4,863 |
| A560 | 89 | New manufacturing use product; registered active ingredient; selective data citation | 12 | 18,234 |
| A570 | 90 | Label amendment requiring data review | 4 | 3,648 |
| 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 | 12,596 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| A520 | 92 | Experimental Use Permit application | 9 | 6,079 |
| 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 | 2,363 |
| 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 | 11,577 |
| 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 | 145,862 |
| 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 | 87,774 |
| 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 | 91,165 |
| 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 | 60,900 |
| A528 | 99 | Experimental Use Permit application, food use; requires tolerance or tolerance exemption | 15 | 21,273 |
| A529 | 100 | Amendment to Experimental Use Permit; requires data review or risk assessment | 9 | 10,884 |
| A523 | 101 | Review of protocol other than a public health efficacy study (i.e., toxicology or exposure protocols) | 9 | 11,577 |
| A571 | 102 | Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated | 18 | 91,165 |
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.
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| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| B580 | 103 | New active ingredient; food use; petition to establish a tolerance | 19 | 48,621 |
| B590 | 104 | New active ingredient; food use; petition to establish a tolerance exemption | 17 | 30,390 |
| B600 | 105 | New active ingredient; non-food use | 13 | 18,234 |
| B610 | 106 | New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption | 10 | 12,156 |
| B611 | 107 | New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption | 12 | 12,156 |
| B612 | 108 | New active ingredient; no change to a permanent tolerance exemption | 10 | 16,714 |
| B613 | 109 | New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption | 11 | 16,714 |
| B620 | 110 | New active ingredient; Experimental Use Permit application; non-food use including crop destruct | 7 | 6,079 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| B630 | 111 | First food use; petition to establish a tolerance exemption | 13 | 12,156 |
| B631 | 112 | New food use; petition to amend an established tolerance | 12 | 12,156 |
| B640 | 113 | New food use; petition to amend an established tolerance | 19 | 18,234 |
| B643 | 114 | New food use; petition to amend tolerance exemption | 10 | 12,156 |
| B642 | 115 | First food use; indoor; food/food handling | 12 | 30,390 |
| B644 | 116 | New use, no change to an established tolerance or tolerance exemption | 8 | 12,156 |
| B650 | 117 | New use; non-food | 7 | 6,079 |
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| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| 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 | 12,156 |
| 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 | 1,217 |
| 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 | 4,863 |
| 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 | 12,156 |
| 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 | 8,683 |
| 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 | 4,863 |
| B674 | 124 | New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only | 4 | 1,217 |
| B675 | 125 | New product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only | 10 | 8,683 |
| 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 | 8,683 |
| 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 for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • animal safety studies and/or • child resistant packaging | 10 | 8,400 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| B621 | 128 | Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption | 7 | 4,863 |
| B622 | 129 | Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption | 11 | 12,156 |
| B641 | 130 | Amendment of an established tolerance or tolerance exemption | 13 | 12,156 |
| B680 | 131 | Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission | 5 | 4,863 |
| B681 | 132 | Amendment; unregistered source of active ingredient(s). Requires data submission | 7 | 5,789 |
| B683 | 133 | Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI) | 6 | 4,863 |
| B684 | 134 | Amending non-food animal product that includes submission of target animal safety data; previously registered | 8 | 8,400 |
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| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| B690 | 135 | New active ingredient; food or non-food use | 7 | 2,432 |
| B700 | 136 | Experimental Use Permit application; new active ingredient or new use | 7 | 1,217 |
| B701 | 137 | Extend or amend Experimental Use Permit | 4 | 1,217 |
| 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 | 1,217 |
| 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 | 1,217 |
| B721 | 140 | New product; unregistered source of active ingredient | 7 | 2,548 |
| B722 | 141 | New use and/or amendment; petition to establish a tolerance or tolerance exemption | 7 | 2,359 |
| B730 | 142 | Label amendment requiring data submission | 5 | 1,217 |
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| B614 | 143 | Conditional ruling on pre-application study waivers; applicant-initiated | 3 | 2,409 |
| B615 | 144 | Rebuttal of agency reviewed protocol, applicant-initiated | 3 | 2,409 |
| B682 | 145 | Protocol review; applicant-initiated; excludes time for HSRB review | 3 | 2,316 |
[top]
| EPA No. | New CR No. | Action | Decision review time (months) | FY '14/15 registration service fee ($) |
|---|---|---|---|---|
| B740 | 146 | Experimental Use Permit 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) | 6 | 91,165 |
| 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 | 121,552 |
| 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 | 182,327 |
| 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 | 121,552 |
| 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 | 12,156 |
| 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 | 30,390 |
| B780 | 152 | Registration application; new PIP; non-food/feed | 12 | 151,940 |
| B790 | 153 | Registration application; new PIP; non-food/feed; SAP review | 18 | 212,715 |
| 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 | 243,165 |
| 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 | 303,878 |
| B820 | 156 | Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient | 15 | 303,878 |
| B840 | 157 | Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review | 21 | 364,653 |
| 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 | 121,552 |
| 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 | 36,466 |
| 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 | 30,390 |
| 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 | 91,165 |
| 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 | 121,552 |
| 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 | 151,940 |
| 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 | 91,165 |
| 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 | 60,777 |
| 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 | 121,552 |
| 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 | 12,156 |
| 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 | 72,931 |
| B902 | 169 | PIP Protocol review | 3 | 6,079 |
| B903 | 170 | Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD | 6 | 60,777 |
| B904 | 171 | Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient) | 9 | 121,552 |
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| EPA No. | New CR No. | Action | Decision review time (months) | FY'14/15 registration service fee ($) |
|---|---|---|---|---|
| I001 | 172 | Approval of new food use inert ingredient | 12 | 18,900 |
| I002 | 173 | Amend currently approved inert ingredient tolerance or exemption from tolerance; new data | 10 | 5,250 |
| I003 | 174 | Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data | 8 | 3,150 |
| I004 | 175 | Approval of new non-food use inert ingredient | 8 | 10,500 |
| I005 | 176 | Amend currently approved non-food use inert ingredient with new use pattern; new data | 8 | 5,250 |
| I006 | 177 | Amend currently approved non-food use inert ingredient with new use pattern; no new data | 6 | 3,150 |
| I007 | 178 | Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern | 4 | 1,575 |
| I008 | 179 | Approval of new polymer inert ingredient, food use | 5 | 3,570 |
| I009 | 180 | Approval of new polymer inert ingredient, non-food use | 4 | 2,940 |
| I010 | 181 | Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data | 6 | 1,575 |
| M001 | 182 | Study protocol requiring Human Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient | 9 | 7,560 |
| M002 | 183 | Completed study requiring Human Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient | 9 | 7,560 |
| 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 section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients | 12 | 60,900 |
| 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 section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients | 18 | 60,900 |
| 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 | 21,000 |
| M006 | 187 | Request for up to 5 letters of certification (Gold Seal) for one actively registered product | 1 | 263 |
| M007 | 188 | Request to extend Exclusive Use of data as provided by FIFRA section 3(c)(1)(F)(ii) | 12 | 5,250 |
| 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 | 1,575 |
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.
[top] 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
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