07-5381. 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: [phone]; fax number: [phone];e-mail address: [e-mail].

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 [phone].

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.

Table 1.-Registration Division—New Active Ingredients

EPA No.	CR No.	Action	Decision time (in months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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 is granted1	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 active ingredient1	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.

TABLE 2.—Registration Division—New Uses

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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.

Table 3.—Registration Division—Import and Other Tolerances

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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.

Table 4.—Registration Division—New Products

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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

Table 5.—Registration Division—Amendments to Registration

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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.

Table 6.—Antimicrobials Division—New Active Ingredients

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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 FIFRA section 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 FIFRA section 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.

Table 7.—Antimicrobials Division—New Uses

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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.

Table 8.—Antimicrobials Division—New Products And Amendments

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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.

Table 9.—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Products and Amendments

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
B580	86	New active ingredient; food use; establish tolerance1	18	18	18	42,000
B590	87	New active ingredient; food use; establish tolerance exemption1	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.

Table 10.—Biopesticides and Pollution Prevention Division—Straight Chain Lepidopteran Pheromones (SCLPs)

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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.

Table 11.—Biopesticide And Pollution Prevention Division—Plant Incorporated Protectants (PIPs)

EPA No.	CR No.	Action	Decision time (months)			FY 08 Registration Service Fee ($)
			FY 08	FY 09	FY 10
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 review required1	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 review required2	12	12	12	131,250
B790	122	New active ingredient; Non-food/feed; SAP review required2	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, [phone].

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.