70 FR 105 pgs. 32327-32335 - Pesticides; Revised Fee Schedule for Registration Applications

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Type: NOTICEVolume: 70Number: 105Pages: 32327 - 32335

Docket number: [OPP-2005-0088; FRL-7706-1]

FR document: [FR Doc. 05-10998 Filed 6-1-05; 8:45 am]

Agency: Environmental Protection Agency

Official PDF Version: PDF Version

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0088; FRL-7706-1]

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 Act (PRIA), the registration service fees for covered pesticide registration applications received on or after October 1, 2005, increase by 5 percent from the fees originally published in the March 17, 2004, Federal Register Notice (69 FR 12772). This revised fee schedule becomes effective on October 1, 2005. The publication of this fee schedule is required by section 33(b)(6)(B) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended by the Consolidated Appropriations Act of 2004.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Leovey, (7501C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7090; fax number: (703) 308-4776; e-mail address: leovey.elizabeth@epa.gov@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, or engage in animal or crop production, food processing or public health activities that use pesticides. Potentially affected entities may include, but are not limited to:

• Crop production - NAICS Code 111

• Animal production - NAICS Code 112

• Food processing - NAICS Code 311

• Pesticide manufacturers - NAICS Code 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 applicability provisions in Unit III. 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 number OPP-2005-0088. 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, 1801 S. Bell St., 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

A. What Action is the Agency Taking?

The Consolidated Appropriations Act of 2004, signed by President Bush on January 23, 2004, established a new section 33 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), creating a registration service fee system for applications for specified pesticide registration, amended registration, and associated tolerance actions. Under this system, the Agency began charging registration service fees 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 FIFRA section 33(b)(3), EPA was required to publish a schedule of the fees and decision times for review of a covered application. This schedule was to be the same as that published in the Congressional Record of September 17, 2003, pages 11631 through 11633. The Agency published this schedule in the Federal Register on March 17, 2004 (69 FR 12772).

Under FIFRA section 33(b)(6), the fee amounts will increase as of October 1, 2005 by 5%. This notice provides the revised fee schedule for applications received on or after October 1, 2005.

B. What is the Agency's Authority for Taking this Action?

The Agency is authorized to issue this notice under section 33(b)(6)(B) of FIFRA.

III. 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 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. 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, using the format utilized in the March 17, 2004, Federal Register Notice (69 FR 12772). 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. These tables only list the decision time review periods for fiscal years 2006, 2007, and 2008 as these are the only applicable review periods for applications received on or after October 1, 2005. Unit IV presents fee tables for the Registration Division (RD) (tables 1 through 5), Unit V presents fee tables for the Antimicrobials Division (AD) (tables 6 through 8), and Unit VI presents fee tables for the Biopesticides and Pollution Prevention Division (BPPD) (tables 9 through 11).

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 three 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 E list the decision times in months for each type of action for Fiscal Years 2006 though 2008. Certain AD decision times are referred to the decision times in FIFRA section 3(h), and thus may be stated differently. The decision review periods in the tables are based upon EPA fiscal years (FY), which run from October 1 through September 30.

• Column F 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

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

• 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

IV. Registration Division Fee Schedules

The Registration Division (RD) 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.

RD-New Active Ingredients	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
R1	56	Food use¹	24	24	24	498,750
R2	57	Food use, reduced risk¹	21	21	21	498,750
R3	58	Food use Experimental Use Permit request submitted simultaneously with application for registration¹ (decision time for Experimental Use Permit and temporary tolerance same as # R4)	24	24	24	551,250
R4	59	Food use Experimental Use Permit, with temporary tolerance, submitted before application for registration ($315K credited toward new AI registration)	18	18	18	367,500
R5	60	Food use Submitted after an Experimental Use Permit¹ (decision time begins after EUP and temporary tolerance are granted)	14	14	14	183,750
R6	61	Non-food use, outdoor¹	21	21	21	346,500
R7	62	Non-food use, outdoor¹ Reduced risk	18	18	18	346,500
R8	63	Non-food use, outdoor¹ Experimental Use Permit request submitted simultaneously with application for registration (decision time for EUP same as #R9)	21	21	21	383,250
R9	64	Non-food use, outdoor Experimental Use Permit submitted before application for registration ($220.5K credited toward new AI registration)	16	16	16	257,250
R10	65	Non-food use, outdoor Submitted after Experimental Use Permit¹ (decision time begins after EUP has been granted)	12	12	12	126,000
R11	66	Non-food use, indoor¹	20	20	20	199,500
R12	67	Non-food use, indoor¹ Reduced risk	17	17	17	199,500
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.

RD-New Uses	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
R13	68	First food use Indoor food/food handling 1	21	21	21	157,500
R14	69	Additional food use Indoor food/food handling	21	15	15	36,750
R15	70	First food use 1	21	21	21	210,000
R16	71	First food use Reduced risk 1	18	18	18	210,000
R17	72	Each additional new food use	22	15	15	52,500
R18	73	Each additional new food use Reduced risk	20	12	12	52,500
R19	74	Additional new food uses, bundled, 6 or more	22	15	15	315,000
R20	75	Additional new food uses, bundled, 6 or more Reduced risk	20	12	12	315,000
R21	76	New food use With Experimental Use Permit and temporary tolerance (no credit toward new use registration)	19	12	12	38,850
R22	77	New food use With Experimental Use Permit, crop destruct basis	6	6	6	15,750
R23	78	New use Non-food, outdoor	20	15	15	21,000
R24	79	New use Non-food, outdoor Reduced risk	18	12	12	21,000
R25	80	New use Non-food, outdoor With Experimental Use Permit (no credit toward new use registration)	6	6	6	15,750
R26	81	New use Non-food, indoor	12	12	12	10,500
R27	82	New use Non-food, indoor Reduced risk	9	9	9	10,500
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.

RD-Import Tolerances	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
R28	83	Import tolerance New active ingredient or first food use¹	21	21	21	262,500
R29	84	Import tolerance Additional new food use	22	15	15	52,500
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.

RD-New Products	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
R30	85	New product Me-too product Fast track	3	3	3	1,050
R31	86	New product Non-fast track (includes reviews of product chemistry, acute toxicity, public health pest efficacy)	6	6	6	4,200
R32	87	New product Non-fast track, new physical form (excludes selective citations)	12	12	12	10,500
R33	88	New manufacturing use product Old AI Selective citation	12	12	12	15,750

RD-Amendments	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
R34	89	Non-fast-track (includes changes to precautionary label statements, source changes to an unregistered source)¹	4	4	4	3,150
R35	90	Non-fast track (changes to REI, PPE, PHI, rate and number of applications, add aerial application, modify GW/SW advisory statement 1	12	8	8	10,500
R36	91	Non-fast track, isomers	18	18	18	252,000
R37	92	Cancer reassessment, applicant-initiated	18	18	18	157,500
¹ EPA-initiated amendments shall not be charged fees.

V. Antimicrobials Division Fee Schedules

The Antimicrobials Division (AD) 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 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.

The AD fee tables use the same terminology as listed in Unit III.

AD-New Active Ingredients	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
A38	36	Food use, with exemption¹	24	24	24	94,500
A39	37	Food use, with tolerance¹	24	24	24	157,500
A40	38	Non-food use, outdoor FIFRA sec 2(mm) uses¹	FIFRA section 3(h) decision times	78,750
A41	39	Non-food use, outdoor, other uses¹	21	21	21	157,500
A42	40	Non-food use, indoor FIFRA sec 2(mm) uses¹	FIFRA section 3(h) decision times	52,500
A43	41	Non-food use, indoor, other uses¹	20	20	20	78,750
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.

AD-New Uses	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
A44	42	New use First food use, with exemption¹	21	21	21	26,250
A45	43	New use First food use, with tolerance¹	21	21	21	78,750
A46	44	New food use, with exemption	15	15	15	10,500
A47	45	New food use, with tolerance	15	15	15	26,250
A48	46	New use Non-food, outdoor FIFRA sec 2(mm) uses	FIFRA section 3(h) decision times	15,750
A49	47	New use, non-food, outdoor, other uses	15	15	15	26,250
A50	48	New use Non-food, indoor FIFRA sec 2(mm) uses	FIFRA section 3(h) decision times	10,500
A51	49	New use Non-food, indoor Other uses	12	12	12	10,500
A52	50	Experimental Use Permit	9	9	9	5,250
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.

AD-New Products and Amendments	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
A53	51	New product, me-too, fast track	3	3	3	1,050
A54	52	New product, non-fast track, FIFRA section 2(mm) uses	FIFRA section 3(h) decision times	4,200
A55	53	New product, non-fast track, other uses	6	6	6	4,200
A56	54	New manufacturing use product, old AI, selective citation	12	12	12	15,750
A57	55	Amendment, non-fast track¹	4	4	4	3,150
¹ EPA-initiated amendents shall not be charged fees.

VI. Biopesticides and Pollution Prevention Division Fee Schedules

The Biopesticides and Pollution Prevention Division (BPPD) is responsible for the processing of pesticide applications for biochemical pesticides, microbial pesticides, and plant-incorporated protectants (PIPs).

The fee tables for BPPD are presented by type of pesticide rather that 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 III.

BPPD-New Products and Amendments	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
B58	3	New AI Food use, with tolerance¹	18	18	18	42,000
B59	4	New AI Food use, with exemption¹	16	16	16	26,250
B60	5	New AI Non-food use¹	12	12	12	15,750
B61	6	Experimental Use Permit Food use, with temporary tolerance exemption	9	9	9	10,500
B62	7	Experimental Use Permit, Non-food use	6	6	6	5,250
B63	8	New use First food use, with exemption	12	12	12	10,500
B64	9	New use First food use, with tolerance¹	18	18	18	15,750
B65	10	New use, non-food	6	6	6	5,250
B66	11	New product Me-too Fast-track	3	3	3	1,050
B67	12	New product Non-fast-track	4	4	4	4,200
B68	13	Amendment² Non-fast-track	4	4	4	4,200
¹ All uses (food and non-food) included in any original application or petition for a new active ingredient or a first use are covered by the base for that applicaiton.
² EPA-initiated amendments shall not be charged fees.

BPPD-Straight Chain Lepidopteran Pheromones	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
B69	14	New AI Food or non-food use¹	6	6	6	2,100
B70	15	Experimental Use Permit New AI or new use	6	6	6	1,050
B71	16	New product Me-too Fast-track	3	3	3	1,050
B72	17	New product, non-fast-track	4	4	4	1,050
B73	18	Amendment, non-fast-track²	4	4	4	1,050
¹ All uses (food and non-food) included in any original application or petition for a new active ingredient or a first use are covered by the base for that applicaiton.
² EPA-initiated amendments shall not be charged fees.

BPPD-Plant Incorporated Protectants	A	A-1	B	C	D	E
EPA No.	CR No.	Action	Fiscal Year	Fee $
			FY 06	FY 07	FY 08
B74	19	Experimental Use Permit Non food/feed or crop destruct No Scientific Advisory Panel review required (if submitted before new AI package, $26.25K credit toward new AI registration)	6	6	6	78,750
B75	20	Experimental Use Permit, with temporary tolerance or exemption No Scientific Advisory Panel review required (if submitted before new AI package, $50.5K credit toward new AI registration)	9	9	9	105,000
B76	21	Experimental Use Permit New AI Non-food/feed or crop destruct Scientific Advisory Panel review required (if submitted before new AI package, $78.75K credit toward new AI registration)	12	12	12	131,250
B77	22	Experimental Use Permit New AI Set temporary tolerance or exemption Scientific Advisory Panel review required (if submitted before new AI package, $105K credit toward new AI registration)	15	15	15	157,500
B78	23	Register new AI Non-food/feed No Scientific Advisory Panel review required	12	12	12	131,250
B79	24	Register new AI Non-food/feed Scientific Advisory Panel review required	18	18	18	236,250
B80	25	Register new AI Temporary tolerance or exemption exists No Scientific Advisory Panel review required	12	12	12	210,000
B81	26	Register new AI Temporary tolerance or exemption exists Scientific Advisory Panel review required	18	18	18	315,000
B82	27	Register new AI Set tolerance or exemption No Scientific Advisory Panel review required	15	15	15	262,500
B83	28	Register new AI Experimental Use Permit request Set tolerance or exemption No Scientific Advisory Panel review required	15	15	15	315,000
B84	29	Register new AI Set tolerance or exemption Scientific Advisory Panel review required	21	21	21	367,500
B85	30	Register new AI With Experimental Use Permit request Set tolerance or exemption Scientific Advisory Panel review required	21	21	21	420,000
B86	31	Experimental Use Permit Food use Amendment	6	6	6	10,500
B87	32	New use¹	9	9	9	31,500
B88	33	New product²	9	9	9	26,250
B89	34	Amendment, seed production to commercial registration	12	9	9	52,500
B90	35	Amendment, non-fast-track³ (except #B89 above)	6	6	6	10,500
¹ Example: Transfer of existing PIP trait by traditional breeding, such as from field corn to sweet corn.
² Example: Stacking PIP traits within a crop using tradtional breeding techniques.
³ EPA-initiated amendments shall not be charged fees.

VII. How to Pay Fees

Applications (or other types of requests) should be submitted to the Agency, at the address given in Unit VIII below. The applicant should 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 should 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 should provide sufficient documentation as described in FIFRA section 33(b)(7). The applicant for a fee waiver may want to consult the Agency's fee waiver guidance for further information ( http://www.epa.gov/pesticides/fees/questions/waiver.htm ). The applicant should not send payment at the time of application.

Thereafter, EPA performs a screen on the application to determine that the category is correct, and assigns a unique identification number to each covered pesticide registration application for which payment is expected. EPA notifies the applicant of the unique identification number together with instructions for submitting payment. This information is 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 should be in U.S. currency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency, and should include the unique identification number assigned to the application.

VIII. Addresses

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

A. By USPS Mail

Mail applications and payments to: Document Processing Desk (REGFEE), Office of Pesticide Programs (7504C), U.S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW, Washington, D.C. 20460-0001

B. By Courier

Couriers and delivery personnel should bring correspondence to: Document Processing Desk (REGFEE), Office of Pesticide Programs,U.S. Environmental Protection Agency, Room 266A, Crystal Mall #2, 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.

Dated: May 24, 2005.

Susan B. Hazen,

Acting Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances.

[FR Doc. 05-10998 Filed 6-1-05; 8:45 am]

BILLING CODE 6560-50-S