Pesticides; Fees and Decision Times for Registration Applications

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is publishing a list of pesticide registration service fees and decision times applicable to specified pesticide applications and tolerance actions. This notice further provides initial guidance on submission of the required fees. The registration service fees will be used to supplement funding for expeditious review of the specified applications and their associated tolerance actions. This fee schedule becomes effective on March 23, 2004, for all covered applications received on or after that date, and for certain pending applications received before that date. Applications not covered by the fee schedule are not subject to the fee requirement or the decision review times. The publication of this fee schedule is required by section 33(b)(3) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended by the Consolidated Appropriations Act of 2004.

FOR FURTHER INFORMATION CONTACT:

Jean M. Frane, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5944; fax number: (703) 305-5884; e-mail address: frane.jean@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you register pesticide products, or engage in animal or crop production, food processing, or public health activities that use pesticides. Potentially affected entities include, but are not limited to:

• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food processing (NAICS 3110)
• Pesticide manufacturers (NAICS 32532)

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 provisions in Unit V. of this document. 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 an official public docket for this action under docket identification (ID) number OPP-2004-0060. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket 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/ . An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

II. Background

The Consolidated Appropriations Act of 2004, signed by President Bush on January 23, 2004, established a new section 33 of FIFRA, which establishes a registration service fee system for applications for specified pesticide registration, amended registration, and associated tolerance actions. Under that system, fees will be charged for covered applications received on or after March 23, 2004, and for certain pending applications received before that date. EPA is required to make a determination on the application within the decision times specified. The fee system is authorized until September 30, 2010, although the decision times under the system do not apply to applications received after September 30, 2008.

Under new section 33(b)(3) of FIFRA, EPA is required to publish a schedule of the fees and decision times for review of a covered application, which schedule is to be the same as that published in the Congressional Record of September 17, 2003, pages 11631 through 11633. Today's notice publishes that schedule, reformatted for clarity and understanding.

The fee schedules in this notice establish fees and decision times for 5 years; however, under section 33(b)(6) of FIFRA, the fee amounts will be increased as of October 1, 2005 by 5%. Furthermore, in FY 2009, the fees will be reduced by 40% and in FY 2010, the fees will be reduced by 70%. EPA will issue appropriate notices in the Federal Register publishing revised schedules.

III. Transition Provisions

A. New Applications Received on or After March 23, 2004

Under section 33(b)(1) of FIFRA, the fees apply to each new application (or other action specified in this notice) received by EPA on or after March 23, 2004. If accompanied by a petition for tolerance, no tolerance fee under 40 CFR 180.33 is required.

B. Pending Applications Received Before March 23, 2004

1. Application for a new active ingredient. (i) Applications for new covered active ingredients received by EPA before March 23, 2004, but that are not on the FY 2003 OPP Registration Division Work Plan are subject to the fees in the tables in this notice. Any fee previously paid in conjunction with the submission of a petition under section 408(m) of the Federal Food, Drug and Cosmetic Act and 40 CFR 180.33 will be credited toward the registration service fee specified in this notice. Readers may access the Registration Division workplan at ww.epa.gov/opprd001/workplan.

(ii) Applications for a new active ingredient received by EPA before March 23, 2004, and that are on the FY 2003 OPP Work Plan are not required to pay the fee in the tables in this notice.

2. All other pending applications. Pending applications other than those for a new active ingredient, i.e., all applications for existing active ingredients, are not required to pay a fee.

IV. How to Pay Fees

Fees apply to covered applications and must be submitted. The majority of covered actions are new applications or requests; the remainder are applications submitted before March 23, 2004. EPA is considering different procedures for each.

Because applications and fees are sent to different addresses, there is potential for confusion and delay if clear procedures for submission, categorization, and verification are not established. EPA intends that the payment and verification of payment process be as expeditious as possible so that Agency review may begin (or continue). To facilitate this process, EPA is issuing the following guidance regarding submission of covered applications and associated fee payments and waiver requests.

A. Required Fees for New Covered Applications

The Agency is considering a two-step process for new covered applications. Under this process an application will first be submitted to the Agency and screened. EPA will then notify the applicant of the categorization of the application and the correct fee to be transmitted to the Agency's lockbox.

Applications (or other type of request) would be submitted to the Agency, at the address given in Unit IX. The applicant would identify the category number (1 through 90) that he believes applies to the action, explain why that category applies, and specify the amount of fee due for that particular action. These notations would be made in the comments section of the application form (EPA Form 8570-1), or in a submittal letter. If the applicant is applying for a fee waiver, the applicant would provide sufficient documentation as described in section 33(b)(7) of FIFRA. The applicant would not send payment at the time of application.

Upon receipt of application, EPA would screen the application to determine that the category is correct, and would assign a unique identification number to each covered pesticide registration application for which payment is expected. Within 3 business days, EPA would notify the applicant of the unique identification number together with instructions for submitting payment. This information would always be sent by mail and by either e-mail or fax at the applicant's request.

After receiving EPA's acknowledgment of the application and its unique identification number, the applicant may submit payment of the fee to the address provided in the acknowledgment. All payments would be in United States currency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency, and would be required to include the unique identifying number assigned to the application.

The Treasury Department is currently upgrading its system for accepting electronic payment, and will not accept new electronic fund transactions at this time. When this situation is resolved, EPA will issue guidance regarding submission of payments via electronic fund transfer.

B. Required Fees for New Active Ingredients Not on the FY 03 Work Plan

Applications for new active ingredients submitted prior to March 23, 2004, and not on OPP's FY 2003 Work Plan are subject to fees. EPA would identify all such applications. EPA would assign each of the applications to the appropriate fee category, and calculate the fee that is due. The amount of fee due would be calculated by identifying the appropriate fee amount in the Fee Schedule and subtracting any previously submitted tolerance fees from that amount. This amount may be further reduced in proportion to the amount of work that has been done on the action prior to March 23, 2004.

EPA intends to notify each affected applicant, and provide instructions for submitting payment.

V. Elements of the Fee Schedule

This unit explains how EPA has organized the fee schedule required by the statute and how to read the fee schedule tables, and provides a key to the terminology published with the table in the Congressional Record. 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 September 17, 2003, identifies the registration service fees and decision times and is organized according to the organizational units of the Office of Pesticide Programs (OPP) within the Environmental Protection Agency (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 categories of fee differ by Division. Further guidance will be issued on the various categories in this fee schedule to improve descriptions and facilitate proper identification for the application process. Not all application types are covered by, or subject to, the fee system.

B. Fee Schedule and Decision Review Times

The table in the Congressional Record is presented as a single table for all Divisions and actions. In issuing today's notice, EPA has reformatted the information to be more user-friendly. EPA has divided the single table from the Congressional Record into 11 tables, organized by OPP Division and by type of application or pesticide subject to the fee. Unit VI. presents fee tables for the Registration Division (RD) (5 tables), Unit VII. presents fee tables for the Antimicrobials Division (AD) (3 tables), and Unit VIII. presents fee tables for the Biopesticides and Pollution Prevention Division (BPPD) (3 tables).

Under section 33(f)(4) of FIFRA, the decision review period for many applications commences within 21 days of EPA's receipt of the application and fee. For the initial stages of implementation, however, EPA intends to exercise flexibility in terms of when EPA's review begins in relationship to its receipt of the fee.

C. How to Read the Tables

1. Each table consists of the following columns:

• Column A numbers the fee categories. There are 90 categories spread across the 3 Divisions. There are 37 RD categories, 20 AD categories and 33 BPPD categories. For tracking purposes, OPP has numbered the 90 categories in sequential order, beginning with RD categories, followed by AD and BPPD categories. This is a change from the sequence of the Congressional Record. 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).
• Column A-1 cross-references the Congressional Record category number for convenience. However, EPA will be using the categories as numbered in Column A in its tracking systems.
• Column B describes the categories of action. The key in this unit is unchanged from that published in the Congressional Record.
• Columns C through G list the decision times in months for each type of action for Fiscal Years 2004 (beginning on March 23, 2004) though 2008. The decision review periods in the tables are based upon EPA fiscal years (FY), which run from October 1 through September 30.
• Column H lists the registration service fee for the action.

2. The tables use a number of abbreviations and acronyms, statutory citations and other terminology that may be unfamiliar to registrants and the public. The following terms are defined in footnotes to the Congressional Record table:

EUP—Experimental Use Permit (EUP)

Fast-track—An application that qualifies for expedited processing under section 3(c)(3)(B)(i)(I) of FIFRA.

GW—Ground Water

Me-too product—A new product registration of an already registered active ingredient.

PHI—Pre-Harvest Interval

PPE—Personal Protective Equipment

REI—Restricted Entry Interval

SAP—FIFRA Scientific Advisory Panel

SW—Surface Water

3. The following footnotes apply to the tables:

Footnote 1—All uses (food and non-food) included in any original application or petition for a new active ingredient or a first food use are covered by the base fee for that application.

Footnote 2—EPA-initiated amendments shall not be charged fees.

Footnote 3—Example: Transfer of existing PIP by traditional breeding, such as from field corn to sweet corn.

Footnote 4—Example: Stacking PIP traits within a crop using traditional breeding techniques.

VI. Registration Division (RD) Fee Schedules

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.

VII. Antimicrobials Division (AD) Fee Schedules

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 section 2(mm)(1)(A) of FIFRA, 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. The Antimicrobials Division fee tables use the same terminology as listed in Unit V.

VIII. Biopesticides and Pollution Prevention Division (BPPD) Fee Schedules

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 plant-incorporated protectants (PIPs). Within each table, the types of application are the same as those in other divisions and use the same terminology as in Unit V.

IX. Addresses

New covered applications should be identified in the title line with the mail code (REGFEE).

A. By USPS Mail

Document Processing Desk (REGFEE)

Office of Pesticide Programs (7504C)

Environmental Protection Agency

1200 Pennsylvania Ave., NW.

Washington, DC 20460-0001

B. By Courier

Document Processing Desk (REGFEE)

Office of Pesticide Programs

Environmental Protection Agency

Room 266A, Crystal Mall #2

1921 Jefferson Davis Hwy.

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 procedures
• Pesticides and pests