Previous Article 72 FR 209 pgs. 61466-61477 - Pesticides; Revised Fee Schedule for Registration Applications
Type: NOTICEVolume: 72Number: 209Pages: 61466 - 61477
Docket number: [EPA-HQ-OPP-2007-1066; FRL-8155-6]
FR document: [FR Doc. 07-5381 Filed 10-29-07; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1066; FRL-8155-6]
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 Renewal Act, the number of fee categories has been increased, the registration service fees for some covered pesticide registration applications received on or after October 1, 2007, have been increased, and certain new procedures have been established. The new fees became effective on October 1, 2007.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Leovey (7501P), Immediate Office, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7328; fax number: (703) 308-4776;e-mail address: leovey.elizabeth@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?
1. Docket . EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-1066. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the " Federal Register " listings at http://www.epa.gov/fedrgstr .
II. Background
In accordance with FIFRA section 33(b)(3), EPA published in the Federal Register of March 17, 2004 (69 FR 12772) (FRL-7348-2), a schedule of the fees and decision times for review of a covered application. Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), establishes 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 established a schedule of decision review times for applications covered by the service fee system. Since March 23, 2004, the Agency has been administering the registration service fee system. The schedule of fees and decision review times was published in the Federal Register of March 17, 2004 (69 FR 12772). Subsequently, as authorized by FIFRA section 33, fees were increased by 5% in a notice issued in the Federal Register of June 2, 2005 (70 FR 32327) (FRL-7706-1).
III. The Pesticide Registration Improvement Renewal Act (PRIRA)
On October 9, 2007, the Pesticide Registration Improvement Renewal Act was signed by the President, revising, among other things, FIFRA section 33. The new law reauthorized the service fee system through 2012 and established fees and review times for applications received during fiscal years 2008 through 2012. The publication of this fee schedule is required by section 33(f)(1) of FIFRA as amended.
Key changes in the new law include the following:
1. The number of fee categories has been increased from 90 to 140. In so doing, new categories were added, particularly in the area of tolerances, review of study protocols, risk assessments not associated with an application, and plant-incorporated protectants (PIPs). In addition, some current categories were split into several new categories to provide more specific listings.
2. The EPA identification system for fee categories has been revised to a 3-digit system to accommodate the increased number of categories. The new fee schedule continues to preface fee categories according to the Divisional responsibilities within OPP (e.g., R for Registration Division). As an example, the fee category for the new category "Enriched isomer(s) of registered mixed-isomer active ingredient" is R122.
3. Fees are due at application. Previously, the application could be submitted to the Agency in advance of fee submittal and EPA would "invoice" or "bill" the applicant for the fee. Units VI. and VII. discuss how the Agency intends to implement this new provision.
4. EPA must within 21 days after receipt of the application and payment reject any application that does not pass the initial content screen and that cannot be corrected. EPA must screen the application within 21 days and make a determination, and verify appropriate fee submission (or a waiver request with at least 25% of the applicable fee accompanying the waiver request).
5. A portion of the fee, 25%, is non-refundable. The amount of a refund for an early withdrawal during the first 60 days of the decision time review period is now 75% of the fee. Previously, the Agency was required to refund 90% for an early withdrawal.
6. A small business fee waiver cannot reduce the fee more than 75% of the appropriate registration service fee instead of 100%, previously.
7. Fees will be increased by 5% for applications received during the period October 1, 2008 through September 30, 2010, and thereafter increased by an additional 5% for applications received as of October 1, 2010. EPA will issue notice in the Federal Register of the new fee schedules as appropriate.
IV. Elements of the Fee Schedule
This unit explains how EPA has organized the fee schedule identified in the statute and how to read the fee schedule tables, and includes a key to terminology published with the table in the Congressional Review. EPA's organization and presentation of the fee schedule information does not affect the categories of registration service fees, or the structure or procedures for submitting applications or petitions for tolerance.
A. The Congressional Record Fee Schedule
The fee schedule published in the Congressional Record of July 21, 2007 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 and examples include:
1. The re-establishment of a time-limited tolerance.
2. Review of confirmatory data submitted in support of an already-issued registration.
3. Submission of a sub-registrant/supplemental distributor label.
4. Special Local Needs Registrations submitted under FIFRA section 24(c).
5. Emergency Exemption Requests submitted under FIFRA section 18.
6. Notifications as described in Pesticide Registration Notice 98-10.
7. Fast track amendments or label amendments that require no data review.
8. Minor formulation amendments as described in Pesticide Registration Notice 98-10.
9. 6(a)2 evaluations.
B. Fee Schedule and Decision Review Times
In today's notice, EPA has retained the format of previous schedule notices and included the corrections to the schedule published in the September 24, 2007 issue of the Congressional Record. These corrections included: The registration service fee for new category No. 133 should be $78,750, rather than $278,250; the decision time for new category No. 47 in fiscal year 3 should be 12 months; and the action description for the new category No. 61 should read: "Non-food use; outdoor; FIFRA, subsection 2(mm) uses (1)." The schedules are presented as 11 tables, organized by OPP Division and by type of application or pesticide subject to the fee. These tables only list the decision time review periods for fiscal years 2008, 2009, and 2010 as these are the only applicable review periods for applications received on or after October 1, 2008. Unit V. presents fee tables for the Registration Division (RD) (5 tables), the Antimicrobials Division (AD) (3 tables), and the Biopesticides and Pollution Prevention Division (BPPD) (3 tables).
C. How to Read the Tables
1. Each table consists of the following columns:
•The column entitled "EPA No." assigns an EPA identifier to each fee category. There are 140 categories spread across the 3 Divisions. There are 58 RD categories, 27 AD categories, and 55 BPPD categories. For tracking purposes, OPP has assigned a 3-digit identifier to each category, beginning with RD categories, followed by AD and BPPD 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).
•The column entitled "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 entitled "Action" describes the categories of action. In establishing the expanded fee schedule categories, Congress eliminated some of the more confusing terminology of the original categories. For example, instead of the term "fast-track," the schedule in the Congressional Record uses the regulatory phrase "identical or substantially similar in composition and use to a registered product."
•The column entitled "Decision Time" list the decision times in months for each type of action for Fiscal Years 2008, 2009, and 2010. The 2010 decision times apply to 2011 and 2012. The decision review periods in the tables are based upon EPA fiscal years (FY), which run from October 1 through September 30.
•The column entitled "FY 08 Registration Service Fee ($)" lists the registration service fee for the action for fiscal year 2008 (October 1, 2007 through September 30, 2008).
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
V. PRIRA Fee Schedule Tables-Effective October 1, 2007
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 5 of Unit V.A. cover RD actions.
| EPA No. | CR No. | Action | Decision time (in months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| R010 | 1 | Food use1 | 24 | 24 | 24 | 516,300 | |
| R020 | 2 | Food use; reduced risk1 | 18 | 18 | 18 | 516,300 | |
| R030 | 3 | Food use; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit and temporary tolerance same as #R0401 | 24 | 24 | 24 | 570,700 | |
| R040 | 4 | Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit $326,025 toward new active ingredient application that follows | 18 | 18 | 18 | 380,500 | |
| R050 | 5 | Food use; application submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit and temporary tolerance are granted1 | 14 | 14 | 14 | 190,300 | |
| R060 | 6 | Non-food use; outdoor1 | 21 | 21 | 21 | 358,700 | |
| R070 | 7 | Non-food use; outdoor; reduced risk1 | 16 | 16 | 16 | 358,700 | |
| R080 | 8 | Non-food use; outdoor; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit same as #R0901 | 21 | 21 | 21 | 396,800 | |
| R090 | 9 | Non-food use; outdoor; Experimental Use Permit application submitted before application for registration; credit $228,225 toward new active ingredient application that follows | 16 | 16 | 16 | 266,300 | |
| R100 | 10 | Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit isgranted1 | 12 | 12 | 12 | 130,500 | |
| R110 | 11 | Non-food use; indoor1 | 20 | 20 | 20 | 199,500 | |
| R120 | 12 | Non-food use; indoor; reduced risk1 | 14 | 14 | 14 | 199,500 | |
| R121 | 13 | Non-food use; indoor; Experimental Use Permit application submitted before application for registration; credit $100,000 toward new active ingredient application that follows | 18 | 18 | 18 | 150,000 | |
| R122 | 14 | Enriched isomer(s) of registered mixed-isomer activeingredient1 | 18 | 18 | 18 | 260,900 | |
| R123 | 15 | Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities1 | 18 | 18 | 18 | 388,200 | |
| R124 | 16 | Conditional Ruling on Preapplication Study Waivers; applicant-initiated | 6 | 6 | 6 | 2,080 | |
| 1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. | |||||||
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| R130 | 17 | First food use; indoor; food/food handling1 | 21 | 21 | 21 | 157,500 | |
| R140 | 18 | Additional food use; Indoor; food/food handling | 15 | 15 | 15 | 36,750 | |
| R150 | 19 | First food use1 | 21 | 21 | 21 | 217,400 | |
| R160 | 20 | First food use; reduced risk1 | 16 | 16 | 16 | 217,400 | |
| R170 | 21 | Additional food use | 15 | 15 | 15 | 54,400 | |
| R180 | 22 | Additional food use; reduced risk | 10 | 10 | 10 | 54,400 | |
| R190 | 23 | Additional food uses; six or more submitted in one application | 15 | 15 | 15 | 326,400 | |
| R200 | 24 | Additional food uses; six or more submitted in one application; reduced risk | 10 | 10 | 10 | 326,400 | |
| R210 | 25 | Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration | 12 | 12 | 12 | 40,300 | |
| R220 | 26 | Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration | 6 | 6 | 6 | 16,320 | |
| R230 | 27 | Additional use; non-food; outdoor | 15 | 15 | 15 | 21,740 | |
| R240 | 28 | Additional use; non-food; outdoor; reduced risk | 10 | 10 | 10 | 21,740 | |
| R250 | 29 | Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration | 6 | 6 | 6 | 16,320 | |
| R260 | 30 | New use; non-food; indoor | 12 | 12 | 12 | 10,500 | |
| R270 | 31 | New use; non-food; indoor; reduced risk | 9 | 9 | 9 | 10,500 | |
| R271 | 32 | New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration | 6 | 6 | 6 | 8,000 | |
| R272 | 33 | Review of Study Protocol; applicant-initiated; excludes DART, pre-registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review | 3 | 3 | 3 | 2,080 | |
| R273 | 34 | Additional use; seed treatment; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses | 12 | 12 | 12 | 41,500 | |
| R274 | 35 | 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 | 12 | 12 | 249,000 | |
| 1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. | |||||||
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| R280 | 36 | Establish import tolerance; new active ingredient or first food use1 | 21 | 21 | 21 | 262,500 | |
| R290 | 37 | Establish import tolerance; additional food use | 15 | 15 | 15 | 52,500 | |
| R291 | 38 | Establish import tolerances; additional food uses; six or more crops submitted in one petition | 15 | 15 | 15 | 315,000 | |
| R292 | 39 | Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated | 10 | 10 | 10 | 37,300 | |
| R293 | 40 | Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated | 12 | 12 | 12 | 44,000 | |
| R294 | 41 | Establish tolerances for inadvertent residues; six or more crops submitted in one application; applicant-initiated | 12 | 12 | 12 | 264,000 | |
| R295 | 42 | Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated | 15 | 15 | 15 | 54,400 | |
| R296 | 43 | Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; six or more crops submitted in one application; applicant-initiated | 15 | 15 | 15 | 326,400 | |
| 1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. | |||||||
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| R300 | 44 | 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. | 3 | 3 | 3 | 1,300 | |
| R301 | 45 | 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 | 4 | 4 | 1,560 | |
| R310 | 46 | New end-use or manufacturing-use product; requires review of data package within RD; includes reviews and/or waivers of data for only: •Product chemistry and/or •Acute toxicity and/or •Public health pest efficacy | 6 | 6 | 6 | 4,360 | |
| R311 | 49 | New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners | 12 | 12 | 12 | 15,540 | |
| R312 | 50 | New product; requires approval of new non-food-use inert; applicant-initiated | 6 | 6 | 6 | 8,300 | |
| R313 | 51 | New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated | 10 | 10 | 10 | 11,420 | |
| R320 | 47 | New product; new physical form; requires data review in science divisions | 12 | 12 | 12 | 10,880 | |
| R330 | 48 | New manufacturing-use product; registered active ingredient; selective data citation | 12 | 12 | 12 | 16,320 | |
| R331 | 52 | New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only | 3 | 3 | 3 | 2,080 | |
| R332 | 53 | New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only | 24 | 24 | 24 | 233,000 |
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| R340 | 54 | Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient)1 | 4 | 4 | 4 | 3,280 | |
| R350 | 55 | Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement)1 | 8 | 8 | 8 | 10,880 | |
| R370 | 56 | Cancer reassessment; applicant-initiated | 18 | 18 | 18 | 163,100 | |
| R371 | 57 | Amendment to Experimental Use Permit; requires data review/risk assessment | 6 | 6 | 6 | 8,300 | |
| R372 | 58 | Refined ecological and/or endangered species assessment; applicant-initiated | 18 | 18 | 12 | 155,300 | |
| 1 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees. | |||||||
B. Antimicrobials Division (AD)
The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 6 through 8 of Unit V.B. cover AD actions.
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| A380 | 59 | Food use; establish tolerance exemption1 | 24 | 24 | 24 | 94,500 | |
| A390 | 60 | Food use; establish tolerance1 | 24 | 24 | 24 | 157,500 | |
| A400 | 61 | Non-food use; outdoor; FIFRA section 2(mm) uses1 | 18 | 18 | 18 | 78,750 | |
| A410 | 62 | Non-food use; outdoor; uses other than FIFRAsection 2(mm)1 | 21 | 21 | 21 | 157,500 | |
| A420 | 63 | Non-food use; indoor; FIFRA section 2(mm) uses1 | 18 | 18 | 18 | 52,500 | |
| A430 | 64 | Non-food use; indoor; uses other than FIFRAsection 2(mm)1 | 20 | 20 | 20 | 78,750 | |
| A431 | 65 | Non-food use; indoor; low-risk and 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 | 12 | 12 | 55,000 | |
| 1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. | |||||||
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| A440 | 66 | First food use; establish tolerance exemption1 | 21 | 21 | 21 | 26,250 | |
| A450 | 67 | First food use; establish tolerance1 | 21 | 21 | 21 | 78,750 | |
| A460 | 68 | Additional food use; establish tolerance exemption | 15 | 15 | 15 | 10,500 | |
| A470 | 69 | Additional food use; establish tolerance | 15 | 15 | 15 | 26,250 | |
| A480 | 70 | Additional use; non-food; outdoor; FIFRA section 2(mm) uses | 9 | 9 | 9 | 15,750 | |
| A490 | 71 | Additional use; non-food; outdoor; uses other than FIFRA section 2(mm) | 15 | 15 | 15 | 26,250 | |
| A500 | 72 | Additional use; non-food; indoor; FIFRA section 2(mm) uses | 9 | 9 | 9 | 10,500 | |
| A510 | 73 | Additional use; non-food; indoor; uses other than FIFRA section 2(mm) | 12 | 12 | 12 | 10,500 | |
| A520 | 74 | Experimental Use Permit application | 9 | 9 | 9 | 5,250 | |
| A521 | 75 | Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 | 6 | 4 | 3 | 2,000 | |
| A522 | 76 | Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2 | 18 | 15 | 12 | 10,000 | |
| 1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. | |||||||
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| A530 | 77 | 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. | 3 | 3 | 3 | 1,050 | |
| A531 | 78 | 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 | 4 | 4 | 1,500 | |
| A532 | 85 | 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 | 4 | 4 | 4 | 4,200 | |
| A540 | 79 | New end use product; FIFRA section 2(mm) uses only | 4 | 4 | 4 | 4,200 | |
| A550 | 80 | New end-use product; uses other than FIFRA section 2(mm); non-FQPA product | 6 | 6 | 6 | 4,200 | |
| A560 | 81 | New manufacturing-use product; registered active ingredient; selective data citation | 12 | 12 | 12 | 15,750 | |
| A570 | 82 | Label amendment requiring data submission1 | 4 | 4 | 4 | 3,150 | |
| A571 | 83 | Cancer reassessment; applicant-initiated | 18 | 18 | 18 | 78,750 | |
| A572 | 84 | Refined ecological risk and/or endangered species assessment; applicant-initiated | 18 | 18 | 12 | 75,000 | |
| 1 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees. | |||||||
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 tables 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 and use the same terminology as in Unit III. Tables 9 through 11 of Unit V.C. cover BPPD actions.
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| B580 | 86 | New active ingredient; food use; establish tolerance1 | 18 | 18 | 18 | 42,000 | |
| B590 | 87 | New active ingredient; food use; establish toleranceexemption1 | 16 | 16 | 16 | 26,250 | |
| B600 | 88 | New active ingredient; non-food use1 | 12 | 12 | 12 | 15,750 | |
| B610 | 89 | Food use; Experimental Use Permit application; establish temporary tolerance exemption | 9 | 9 | 9 | 10,500 | |
| B620 | 90 | Non-food use; Experimental Use Permit application | 6 | 6 | 6 | 5,250 | |
| B621 | 91 | Extend or amend Experimental Use Permit | 6 | 6 | 6 | 4,200 | |
| B630 | 92 | First food use; establish tolerance exemption | 12 | 12 | 12 | 10,500 | |
| B631 | 93 | Amend established tolerance exemption | 9 | 9 | 9 | 10,500 | |
| B640 | 94 | First food use; establish tolerance1 | 18 | 18 | 18 | 15,750 | |
| B641 | 95 | Amend established tolerance (e.g., decrease or increase) | 12 | 12 | 12 | 10,500 | |
| B650 | 96 | New use; non-food | 6 | 6 | 6 | 5,250 | |
| B660 | 97 | 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. | 3 | 3 | 3 | 1,050 | |
| B670 | 98 | New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales | 6 | 6 | 6 | 4,200 | |
| B671 | 99 | New product; food use; unregistered source of active ingredient; requires amendment of established tolerance or tolerance exemption; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales | 16 | 16 | 16 | 10,500 | |
| B672 | 100 | New product; non-food use or food use having established tolerance or tolerance exemption; unregistered source of active ingredient; no data compensation issues; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales | 12 | 12 | 12 | 7,500 | |
| B680 | 101 | Label amendment requiring data submission2 | 4 | 4 | 4 | 4,200 | |
| B681 | 102 | Label amendment; unregistered source of active ingredient; supporting data require scientific review | 6 | 6 | 6 | 5,000 | |
| B682 | 103 | Protocol review; applicant-initiated; excludes time for HSRB review (preapplication) | 3 | 3 | 3 | 2,000 | |
| 1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. | |||||||
| 2 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees. | |||||||
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| B690 | 104 | New active ingredient; food or non-food use1 | 6 | 6 | 6 | 2,100 | |
| B700 | 105 | Experimental Use Permit application; new active ingredient or new use | 6 | 6 | 6 | 1,050 | |
| B701 | 106 | Extend or amend Experimental Use Permit | 3 | 3 | 3 | 1,050 | |
| B710 | 107 | 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. | 3 | 3 | 3 | 1,050 | |
| B720 | 108 | New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales | 4 | 4 | 4 | 1,050 | |
| B721 | 109 | New product; unregistered source of active ingredient | 6 | 6 | 6 | 2,200 | |
| B722 | 110 | New use and/or amendment to tolerance or tolerance exemption | 6 | 6 | 6 | 2,200 | |
| B730 | 111 | Label amendment requiring data submission2 | 4 | 4 | 4 | 1,050 | |
| 1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. | |||||||
| 2 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees. | |||||||
| EPA No. | CR No. | Action | Decision time (months) | FY 08 | FY 09 | FY 10 | FY 08 Registration Service Fee ($) |
|---|---|---|---|---|---|---|---|
| B740 | 112 | Experimental Use Permit application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review required1 | 6 | 6 | 6 | 78,750 | |
| B750 | 113 | Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP reviewrequired1 | 9 | 9 | 9 | 105,000 | |
| B760 | 114 | Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct basis; SAP review required; credit $78,750 toward new active ingredient application that follows | 12 | 12 | 12 | 131,250 | |
| B761 | 115 | Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct; no SAP review required; credit $78,750 toward new active ingredient application that follows | 7 | 7 | 7 | 78,750 | |
| B770 | 116 | Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; SAP review required; credit $105,000 toward new active ingredient application that follows | 15 | 15 | 15 | 157,500 | |
| B771 | 117 | Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required; credit $105,000 toward new active ingredient application that follows | 10 | 10 | 10 | 105,000 | |
| B772 | 118 | Amend or extend Experimental Use Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected | 3 | 3 | 3 | 10,500 | |
| B773 | 119 | Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption | 5 | 5 | 5 | 26,250 | |
| B860 | 120 | Amend Experimental Use Permit; first food use or major revision of experimental design | 6 | 6 | 6 | 10,500 | |
| B780 | 121 | New active ingredient; non-food/feed; no SAP reviewrequired2 | 12 | 12 | 12 | 131,250 | |
| B790 | 122 | New active ingredient; Non-food/feed; SAP reviewrequired2 | 18 | 18 | 18 | 183,750 | |
| B800 | 123 | New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required2 | 12 | 12 | 12 | 210,000 | |
| B810 | 124 | New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP review required2 | 18 | 18 | 18 | 262,500 | |
| B820 | 125 | New active ingredient; establish tolerance or tolerance exemption; no SAP review required2 | 15 | 15 | 15 | 262,500 | |
| B840 | 126 | New active ingredient; establish tolerance or tolerance exemption; SAP review required2 | 21 | 21 | 21 | 315,000 | |
| B830 | 127 | New active ingredient; Experimental Use Permit application submitted simultaneously; establish tolerance or tolerance exemption; no SAP review required2 | 15 | 15 | 15 | 315,000 | |
| B850 | 128 | New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required2 | 21 | 21 | 21 | 367,500 | |
| B851 | 129 | New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; no SAP review required | 9 | 9 | 9 | 105,000 | |
| B852 | 130 | New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; SAP review required | 9 | 9 | 9 | 157,500 | |
| B870 | 131 | New use1 | 9 | 9 | 9 | 31,500 | |
| B880 | 132 | New product; no SAP review required3 | 9 | 9 | 9 | 26,250 | |
| B881 | 133 | New product; SAP review required3 | 15 | 15 | 15 | 78,750 | |
| B890 | 134 | Amendment; seed production to commercial registration; no SAP review required | 9 | 9 | 9 | 52,500 | |
| B891 | 135 | Amendment; seed production to commercial registration; SAP review required | 15 | 15 | 15 | 105,000 | |
| B900 | 136 | Amendment (except B890); No SAP review required; (e.g., new IRM requirements that are applicant initiated; or amending a conditional registration to extend the registration expiration date with additional data submitted)4 | 6 | 6 | 6 | 10,500 | |
| B901 | 137 | Amendment (except B890); SAP review required4 | 12 | 12 | 12 | 63,000 | |
| B902 | 138 | PIP Protocol review | 3 | 3 | 3 | 5,250 | |
| B903 | 139 | Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD | 6 | 6 | 6 | 52,500 | |
| B904 | 140 | Import tolerance or tolerance exemption; processed commodities/food only | 9 | 9 | 9 | 105,000 | |
| 1 Example: Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn. | |||||||
| 2 May be either a registration for seed increase or a full commercial registration. If a seed increase registration is granted first, full commercial registration is obtained using B890. | |||||||
| 3 Example: Stacking PIP traits within a crop using traditional breeding techniques. | |||||||
| 4 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees. | |||||||
VI. How to Pay Fees
Applicants must now 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 (and other amounts) 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 website www.pay.gov .
1. From the pay.gov home page, under "Find Public Forms."
2. Select "search by form name."
3. On the A-Z Index of Forms page, select "P."
4. From the list of forms on the second page, select "Pre-payment of Pesticide Registration Improvement Act Fee."
5. Complete the form entering the PRIA fee category and fee.
6. 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 should be in United States currency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency. On the check, the applicant must supply in the information line either the registration number of the product or the company number. A copy of the check must accompany the application to the Agency, specifically attached to the front of the application. The copy of the check ensures that payment has been made at the time of application and will enable the Agency to properly connect the payment with the application sent to the Agency.
If you send the Agency a check, it will be converted into an electronic funds transfer (EFT). This means the Agency will copy your check and use the account information on it to electronically debit your account for the amount of the check. The debit from your account will usually occur within 24 hours, and will be shown on your regular account statement.
You will not receive your original check back. The Agency will destroy your original check, but will keep the copy of it. If the EFT cannot be processed for technical reasons, you authorize the Agency to process the copy in place of your original check. If the EFT cannot be completed because of insufficient funds, the Agency may try to make the transfer up to two times.
All paper-based payments should be sent to the following address:
1. 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.
2. 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.
VII. How to Submit Applications
Submissions to the Agency should be made at the address given in Unit VIII. The applicant should attach documentation that the fee has been paid which may be a copy of the check or 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 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 e-mail if EPA has either an e-mail address on file or an e-mail address is provided on the application.
VIII. Addresses
New covered applications should be identified in the title line with the mail code REGFEE.
1. By USPS mail . Document Processing Desk (REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001.
2. 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: October 23, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.
[FR Doc. 07-5381 Filed 10-29-07; 8:45 am]
BILLING CODE 6560-50-S