2010-19720. 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. In accordance with the Pesticide Registration Improvement Renewal Act, the registration service fees for covered pesticide registration applications received on or after October 1, 2010, will increase by 5 percent, rounded up to the nearest dollar amount, from the fees published for fiscal years 2009 and 2010. The new fees become effective on October 1, 2010.

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 (32532).
• Antimicrobial pesticide manufacturers (32561).
• Antifoulant pesticide manufacturers (32551).
• Wood preservative manufacturers (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?

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2010-0599. 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].

II. Background

A. What Action is the Agency Taking?

The Pesticide Registration Improvement Act of 2003 (PRIA), established a new section 33 of FIFRA creating a registration service fee system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. The Agency began administering the registration service fee system for covered applications received on or after March 23, 2004.

On 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. As required by section 33(b)(6)(B) of FIFRA, the registration service fees for covered pesticide registration applications received on or after October 1, 2010, will increase by 5 percent, rounded up to the nearest dollar amount, from the fees published in the August 5, 2008, Federal Register Notice (73 FR 45438).

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

The publication of this fee schedule is required by section 33(b)(6)(C) of FIFRA as amended.

III. Elements of the Fee Schedule

This unit explains how 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 (Divisions) of the Office of Pesticide Programs (OPP) within EPA. Thereafter, the categories within the organizational unit sections of the table are further categorized according to the type of application being submitted, the use patterns involved, or, in some cases, upon the type of pesticide that is the subject of the application. The fee categories differ by Division. Not all application types are covered by, or subject to, the fee system.

B. Fee Schedule and Decision Review Times

In today's notice, EPA has retained the format of previous schedule notices and included the corrections to the schedule published in the September 24, 2007 issue of the Congressional Record. 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 2011 and 2012 as these are the only applicable review periods for applications received on or after October 1, 2010. Unit IV 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” lists the decision times in months for each type of action for Fiscal Years 2011 and 2012. 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 11/12 Registration Service Fee ($)” lists the registration service fee for the action for fiscal year 2010 (October 1, 2010 through September 30, 2011) and fiscal year 2011 (October 1, 2011 through September 30, 2012).

2. The following acronyms are used in some of the tables:

• DART = Dose Adequacy Response Team
• DNT = Developmental Neurotoxicity
• GW/SW = Ground Water/Surface Water
• HSRB = Human Studies Review Board
• PHI = Pre-Harvest Interval
• PPE = Personal Protective Equipment
• REI = Restricted Entry Interval
• SAP = FIFRA Scientific Advisory Panel

IV. PRIRA Fee Schedule Tables—Effective October 1, 2010

A. Registration Division

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 (months) FY 11/12	FY 11/12 Registration Service Fee ($)
R010	1	Food use1	24	569,221
R020	2	Food use; reduced risk1	18	569,221
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	629,197
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	419,502
R050	5	Food use; application submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit and temporary tolerance are granted1	14	209,806
R060	6	Non-food use; outdoor1	21	395,467
R070	7	Non-food use; outdoor; reduced risk1	16	395,467
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	437,472
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	293,596
R100	10	Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit is granted1	12	143,877
R110	11	Non-food use; indoor1	20	219,949
R120	12	Non-food use; indoor; reduced risk1	14	219,949
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	165,375
R122	14	Enriched isomer(s) of registered mixed-isomer active ingredient1	18	287,643
R123	15	Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities1	18	427,991
R124	16	Conditional Ruling on Preapplication Study Waivers; applicant-initiated	6	2,294
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 11/12	FY 11/12 Registration Service Fee ($)
R130	17	First food use; indoor; food/food handling1	21	173,644
R140	18	Additional food use; Indoor; food/food handling	15	40,518
R150	19	First food use1	21	239,684
R160	20	First food use; reduced risk1	16	239,684
R170	21	Additional food use	15	59,976
R180	22	Additional food use; reduced risk	10	59,976
R190	23	Additional food uses; 6 or more submitted in one application	15	359,856
R200	24	Additional food uses; 6 or more submitted in one application; reduced risk	10	359,856
R210	25	Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration	12	44,431
R220	26	Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration	6	17,993
R230	27	Additional use; non-food; outdoor	15	23,969
R240	28	Additional use; non-food; outdoor; reduced risk	10	23,969
R250	29	Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration	6	17,993
R260	30	New use; non-food; indoor	12	11,577
R270	31	New use; non-food; indoor; reduced risk	9	11,577
R271	32	New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration	6	8,820
R272	33	Review of Study Protocol; applicant-initiated; excludes DART, pre-registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review	3	2,294
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	45,754
R274	35	Additional uses; seed treatment only; 6 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	274,523
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 11/12	FY 11/12 Registration Service Fee ($)
R280	36	Establish import tolerance; new active ingredient or first food use1	21	289,407
R290	37	Establish import tolerance; additional food use	15	57,882
R291	38	Establish import tolerances; additional food uses; 6 or more crops submitted in one petition	15	347,288
R292	39	Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated	10	41,124
R293	40	Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated	12	48,510
R294	41	Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated	12	291,060
R295	42	Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated	15	59,976
R296	43	Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated	15	359,856
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 11/12	FY 11/12 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	1,434
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	1,720
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	4,807
R311	49	New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners	12	17,133
R312	50	New product; requires approval of new non-food-use inert; applicant-initiated	6	9,151
R313	51	New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated	10	12,591
R320	47	New product; new physical form; requires data review in science divisions	12	11,996
R330	48	New manufacturing-use product; registered active ingredient; selective data citation	12	17,993
R331	52	New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only	3	2,294
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	256,883

Table 5.—Registration Division—Amendments To Registration

EPA No.	CR No.	Action	Decision Time (months) FY 11/12	FY 11/12 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	3,617
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	11,996
R370	56	Cancer reassessment; applicant-initiated	18	179,818
R371	57	Amendment to Experimental Use Permit; requires data review / risk assessment	6	9,151
R372	58	Refined ecological and/or endangered species assessment; applicant-initiated	12	171,219
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

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 11/12	FY 11/12 Registration Service Fee ($)
A380	59	Food use; establish tolerance exemption1	24	104,187
A390	60	Food use; establish tolerance1	24	173,644
A400	61	Non-food use; outdoor; FIFRA section 2(mm) uses1	18	86,823
A410	62	Non-food use; outdoor; uses other than FIFRA section 2(mm)1	21	173,644
A420	63	Non-food use; indoor; FIFRA section 2(mm) uses1	18	57,882
A430	64	Non-food use; indoor; uses other than FIFRA section 2(mm)1	20	86,823
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	60,638
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 11/12	FY 11/12 Registration Service Fee ($)
A440	66	First food use; establish tolerance exemption1	21	28,942
A450	67	First food use; establish tolerance1	21	86,823
A460	68	Additional food use; establish tolerance exemption	15	11,577
A470	69	Additional food use; establish tolerance	15	28,942
A480	70	Additional use; non-food; outdoor; FIFRA section 2(mm) uses	9	17,365
A490	71	Additional use; non-food; outdoor; uses other than FIFRA section 2(mm)	15	28,942
A500	72	Additional use; non-food; indoor; FIFRA section 2(mm) uses	9	11,577
A510	73	Additional use; non-food; indoor; uses other than FIFRA section 2(mm)	12	11,577
A520	74	Experimental Use Permit application	9	5,789
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	3	2,205
A522	76	Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2	12	11,025
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 11/12	FY 11/12 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	1,159
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	1,654
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	4,631
A540	79	New end use product; FIFRA section 2(mm) uses only	4	4,631
A550	80	New end-use product; uses other than FIFRA section 2(mm); non-FQPA product	6	4,631
A560	81	New manufacturing-use product; registered active ingredient; selective data citation	12	17,365
A570	82	Label amendment requiring data submission1	4	3,474
A571	83	Cancer reassessment; applicant-initiated	18	86,823
A572	84	Refined ecological risk and/or endangered species assessment; applicant-initiated	12	82,688
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

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

The fee tables for BPPD actions are presented by type of pesticide rather than by type of action: Table 9—Microbial and biochemical pesticides; Table 10—straight chain lepidopteran pheromones (SCLPs), and Table 11—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.

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

EPA No.	CR No.	Action	Decision Time (months) FY 11/12	FY 11/12 Registration Service Fee ($)
B580	86	New active ingredient; food use; establish tolerance1	18	46,305
B590	87	New active ingredient; food use; establish tolerance exemption1	16	28,942
B600	88	New active ingredient; non-food use1	12	17,365
B610	89	Food use; Experimental Use Permit application; establish temporary tolerance exemption	9	11,577
B620	90	Non-food use; Experimental Use Permit application	6	5,789
B621	91	Extend or amend Experimental Use Permit	6	4,631
B630	92	First food use; establish tolerance exemption	12	11,577
B631	93	Amend established tolerance exemption	9	11,577
B640	94	First food use; establish tolerance1	18	17,365
B641	95	Amend established tolerance (e.g., decrease or increase)	12	11,577
B650	96	New use; non-food	6	5,789
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	1,159
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	4,631
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	11,577
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	8,269
B680	101	Label amendment requiring data submission2	4	4,631
B681	102	Label amendment; unregistered source of active ingredient; supporting data require scientific review	6	5,513
B682	103	Protocol review; applicant-initiated; excludes time for HSRB review (pre application)	3	2,205
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 11/12	FY 11/12 Registration Service Fee ($)
B690	104	New active ingredient; food or non-food use1	6	2,316
B700	105	Experimental Use Permit application; new active ingredient or new use	6	1,159
B701	106	Extend or amend Experimental Use Permit	3	1,159
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	1,159
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	1,159
B721	109	New product; unregistered source of active ingredient	6	2,426
B722	110	New use and/or amendment to tolerance or tolerance exemption	6	2,426
B730	111	Label amendment requiring data submission2	4	1,159
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 11/12	FY 11/12 Registration Service Fee ($)
B740	112	Experimental Use Permit application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review required1	6	86,823
B750	113	Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required1	9	115,763
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	144,704
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	86,823
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	173,644
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	115,763
B772	118	Amend or extend Experimental Use Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected	3	11,577
B773	119	Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption	5	28,942
B860	120	Amend Experimental Use Permit; first food use or major revision of experimental design	6	11,577
B780	121	New active ingredient; non-food/feed; no SAP review required2	12	144,704
B790	122	New active ingredient; Non-food/feed; SAP review required2	18	202,585
B800	123	New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required2	12	231,525
B810	124	New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP review required2	18	289,407
B820	125	New active ingredient; establish tolerance or tolerance exemption; no SAP review required2	15	289,407
B840	126	New active ingredient; establish tolerance or tolerance exemption; SAP review required2	21	347,288
B830	127	New active ingredient; Experimental Use Permit application submitted simultaneously; establish tolerance or tolerance exemption; no SAP review required2	15	347,288
B850	128	New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required2	21	405,169
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	115,763
B852	130	New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; SAP review required	9	173,644
B870	131	New use1	9	34,729
B880	132	New product; no SAP review required3	9	28,942
B881	133	New product; SAP review required3	15	86,823
B890	134	Amendment; seed production to commercial registration; no SAP review required	9	57,882
B891	135	Amendment; seed production to commercial registration; SAP review required	15	115,763
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	11,577
B901	137	Amendment (except #B890); SAP review required4	12	69,458
B902	138	PIP Protocol review	3	5,789
B903	139	Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD	6	57,882
B904	140	Import tolerance or tolerance exemption; processed commodities/food only	9	115,763
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.

V. How to Pay Fees

Applicants must submit fee payments at the time of application, and EPA will reject any application that does not contain evidence that the fee has been paid. The EPA has developed a web site at http://www.epa.gov/​pesticides/​fees/​tool/​index.htm to help applicants identify the fee category and the fee. All fees should be rounded up to the nearest 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 at http://www.pay.gov as follows:

1. From the pay.gov home page, under “Find Public Forms.” select “search by Agency name.”

2. On the A-Z Index of Forms page, select “E.”

3. Select “Environmental Protection Agency.”

4. From the list of forms, select “Pesticide Registration Improvement Act Fee - Pre-Payment.”

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 must be in U.S. 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 by one of the following methods:

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].

VI. 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 pay.gov payment acknowledgement or a copy of the check. If the applicant is applying for a fee waiver, the applicant should provide sufficient documentation as described in FIFRA section 33(b)(7) and http://www.epa.gov/​pesticides/​fees/​questions/​waivers.htm. The fee waiver request should be easy to identify and separate from the rest of the application and submitted with documentation that at least 25 percent 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 will notify 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.

VII. Addresses

New covered applications should be identified in the title line with the mail code REGFEE and sent by one of the following methods:

1. By USPS mail. Document Processing Desk (REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, D.C. 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: August 4, 2010.

Steven Bradbury,

Director, Office of Pesticides Programs.