2013-23368. 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 Extension Act, the registration service fees for covered pesticide registration applications received on or after October 1, 2013, increase by 5% rounding up to the nearest dollar from the fees published for fiscal year 2012. The new fees become effective on October 1, 2013.

FOR FURTHER INFORMATION CONTACT:

Peter Caulkins (7501P), Immediate Office, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; email 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?

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0621, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the OPP Docket is [phone]. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.

II. Background

A. What action is the Agency taking?

The Pesticide Registration Improvement Act of 2003 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 September 28, 2012, the Pesticide Registration Improvement Extension Act was signed by the President, revising, among other things, FIFRA section 33. The new law reauthorized the service fee system through fiscal year 2017 and established fees and review times for applications received during fiscal years 2013 through 2017. As required by section 33(b)(6)(A) of FIFRA, the registration service fees for covered pesticide registration applications received on or after October 1, 2013, increase by 5% rounding up to the nearest dollar from the fees published in the September 28, 2012 Pesticide Registration Improvement Extension Act.

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 to read the fee schedule tables, and includes a key to terminology published with the table.

A. The Pesticide Registration Improvement Extension Act Fee Schedule

The fee schedule published in the Pesticide Registration Improvement Extension Act of September 28, 2013, 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.

B. Fee Schedule and Decision Review Times

In today's notice, EPA has retained the format of the tables included in the Pesticide Registration Improvement Extension Act of September 28, 2012. The schedules are presented as 18 tables, organized by OPP Division and by type of application or pesticide subject to the fee. Unit IV. presents fee tables for the Registration Division (RD) (6 tables), the Antimicrobials Division (AD) (4 tables), the Biopesticides and Pollution Prevention Division (BPPD) (7 tables), and Inert Ingredients, External Review and Miscellaneous (1 table).

C. How To Read the Tables

1. Each table consists of the following columns:

• The column titled “EPA No.”' assigns an EPA identifier to each fee category. There are 189 categories spread across the 3 Divisions. There are 63 RD categories, 39 AD categories, 69 BPPD categories, 10 inert categories, and 8 miscellaneous categories. For tracking purposes, OPP has assigned a 3-digit identifier to each category, beginning with RD categories, followed by AD, BPPD, inert and miscellaneous 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, I=inert ingredients, M= miscellaneous).
• The column titled “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 titled “Action”' describes what registration actions are covered by each category.
• The column titled “Decision Time” lists the decision times in months for each type of action.
• The column titled “FY 2014/FY 2015 Registration Service Fee ($)” lists the registration service fee for the action for fiscal year 2014 (October 1, 2013 through September 30, 2014) and fiscal year 2015 (October 1, 2014 through September 30, 2015).
• Footnote text has been removed to save on Federal Register costs but remains unchanged from what was published in FY 2013. The tables and footnote text will be available in full after October 1 at http://www.epa.gov/​pesticides/​regulating/​fees/​tool/​category-table.html.

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.

IV. PRIA Fee Schedule Tables—Effective October 1, 2013

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 6 cover RD actions.

Table 1—Registration Division—New Active Ingredients

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
R010	1	New active ingredient, food use	24	597,683
R020	2	New active ingredient, food use; reduced risk	18	597,683
R040	3	New active ingredient, food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows	18	440,478
R060	4	New active ingredient, non-food use; outdoor	21	415,241
R070	5	New active ingredient, non-food use; outdoor; reduced risk	16	415,241
R090	6	New active ingredient, non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows	16	308,276
R110	7	New active ingredient, non-food use; indoor	20	230,947
R120	8	New active ingredient, non-food use; indoor; reduced risk	14	230,947
R121	9	New active ingredient, non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows	18	173,644
R122	10	Enriched isomer(s) of registered mixed-isomer active ingredient	18	302,026
R123	11	New active ingredient, seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities	18	449,391
R125	12	New active ingredient, seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows	16	308,276

Table 2—Registration Division—New Uses

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
R130	13	First food use; indoor; food/food handling	21	182,327
R140	14	Additional food use; indoor; food/food handling	15	42,544
R150	15	First food use	21	251,669
R160	16	First food use; reduced risk	16	251,669
R170	17	Additional food use	15	62,975
R175	18	Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups	10	62,975
R180	19	Additional food use; reduced risk	10	62,975
R190	20	Additional food uses; six or more submitted in one application	15	377,849
R200	21	Additional food use; six or more submitted in one application; reduced risk	10	377,849
R210	22	Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration	12	46,653
R220	23	Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration	6	18,893
R230	24	Additional use; non-food; outdoor	15	25,168
R240	25	Additional use; non-food; outdoor; reduced risk	10	25,168
R250	26	Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration	6	18,893
R251	27	Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis	8	18,893
R260	28	New use; non-food; indoor	12	12,156
R270	29	New use; non-food; indoor; reduced risk	9	12,156
R271	30	New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration	6	9,261
R273	31	Additional use; seed treatment; 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	48,042
R274	32	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	288,250

Table 3—Registation Division—Import and Other Tolerances

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
R280	33	Establish import tolerance; new active ingredient or first food use	21	303,878
R290	34	Establish Import tolerance; additional new food use	15	60,777
R291	35	Establish import tolerances; additional food uses; six or more crops submitted in one petition	15	364,653
R292	36	Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated	11	43,181
R293	37	Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated	12	50,936
R294	38	Establish tolerances for inadvertent residues; six or more crops submitted in one application; applicant-initiated	12	305,613
R295	39	Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated	15	62,975
R296	40	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	377,849
R297	41	Amend six or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated	11	259,082
R298	42	Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated)	13	55,776
R299	43	Amend six or more established tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated)	13	271,677

Table 4—Registration Division—New Products

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
R300	44	New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP—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% repackage of registered end-use or manufacturing-use product that requires no data submission nor data matrix	4	1,506
R301	45	New product; or similar combination product (already registered) to an 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	1,806
R310	46	New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • child resistant packaging	7	5,048
R314	47	New end-use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • child resistant packaging	8	6,310
R315	48	New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • animal safety studies and/or • child resistant packaging	9	8,400
R320	49	New product; new physical form; requires data review in science divisions	12	12,596
R331	50	New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only	3	2,409
R332	51	New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions	24	269,728
R333	52	New product; MUP or end-use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data	10	18,893
R334	53	New product; MUP or end-use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation	11	18,893

Table 5—Registration Division—Amendments to Registration

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
R340	54	Amendment requiring data review within RD (e.g., changes to precautionary label statements)	4	3,798
R345	55	Amending non-food animal product that includes submission of target animal safety data; previously registered	7	8,400
R350	56	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)	9	12,596
R351	57	Amendment adding a new unregistered source of active ingredient	8	12,596
R352	58	Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data	8	12,596
R371	59	Amendment to Experimental Use Permit; (does not include extending a permit's time period)	6	9,609

Table 6—Registration Division—Other Actions

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
R124	60	Conditional ruling on pre-application study waivers; applicant-initiated	6	2,409
R272	61	Review of study protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review	3	2,409
R275	62	Rebuttal of agency reviewed protocol, applicant-initiated	3	2,409
R370	63	Cancer reassessment; applicant-initiated	18	188,809

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 7 through 10 cover AD actions.

Table 7—Antimicrobials Division—New Active Ingredients

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
A380	64	New active ingredient food use, establish tolerance exemption	24	109,397
A390	65	New active ingredient food use, establish tolerance	24	182,327
A400	66	New active ingredient, non-food use, outdoor, FIFRA section 2(mm) uses	18	91,165
A410	67	New active ingredient non-food use, outdoor, uses other than FIFRA section 2(mm)	21	182,327
A420	68	New active ingredient non-food use, indoor, FIFRA section 2(mm) uses	18	60,777
A430	69	New active ingredient, non-food use indoor, uses other than FIFRA section 2(mm) uses	20	91,165
A431	70	New active ingredient, non-food use; indoor; low-risk; 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	63,670

Table 8—Antimicrobials Division—New Uses

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
A440	71	New use, first food use; establish tolerance exemption	21	30,390
A450	72	New use, first food use; establish tolerance	21	91,165
A460	73	New use, additional food use; establish tolerance exemption	15	12,156
A470	74	New use, additional food use; establish tolerance	15	30,390
A471	75	Additional food uses; establish tolerances; six or more submitted in one application	15	182,335
A480	76	New use, additional use, non-food, outdoor; FIFRA section 2(mm) uses	9	18,234
A481	77	Additional non-food outdoor uses; FIFRA section 2(mm) uses; six or more submitted in one application	9	109,400
A490	78	New use, additional use, non-food, outdoor, uses other than FIFRA section 2(mm)	15	30,390
A491	79	Additional non-food; outdoor; uses other than FIFRA section 2(mm); six or more submitted in one application	15	182,335
A500	80	New use, additional use, non-food, indoor FIFRA section 2(mm) uses	9	12,156
A501	81	Additional non-food; indoor; FIFRA section 2(mm) uses; six or more submitted in one application	9	72,936
A510	82	New use, additional use, non-food, indoor, other than FIFRA section 2(mm)	12	12,156
A511	83	Additional non-food; indoor; uses other than FIFRA section 2(mm); six or more submitted in one application	12	72,936

Table 9—Antimicrobials Division—New Products and Amendments

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
A530	84	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	4	1,217
A531	85	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	1,737
A532	86	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	5	4,863
A540	87	New end-use product; FIFRA section 2(mm) uses only	5	4,863
A550	88	New end-use product; uses other than FIFRA section 2(mm); non-FQPA product	7	4,863
A560	89	New manufacturing use product; registered active ingredient; selective data citation	12	18,234
A570	90	Label amendment requiring data review	4	3,648
A572	91	New product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate)	9	12,596

Table 10—Antimicrobials Division—Experimental Use Permits and Other Type of Actions

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
A520	92	Experimental Use Permit application	9	6,079
A521	93	Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1	3	2,363
A522	94	Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2	12	11,577
A524	95	New active ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows	18	145,862
A525	96	New active ingredient, Experimental Use Permit application; food use requires tolerance exemption. Credit 45% of fee toward new active ingredient application that follows	18	87,774
A526	97	New active ingredient, Experimental Use Permit application; non-food, outdoor use. Credit 45% of fee toward new active ingredient application that follows	15	91,165
A527	98	New active ingredient, Experimental Use Permit application; non-food, indoor use. Credit 45% of fee toward new active ingredient application that follows	15	60,900
A528	99	Experimental Use Permit application, food use; requires tolerance or tolerance exemption	15	21,273
A529	100	Amendment to Experimental Use Permit; requires data review or risk assessment	9	10,884
A523	101	Review of protocol other than a public health efficacy study (i.e., toxicology or exposure protocols)	9	11,577
A571	102	Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated	18	91,165

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 actions 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. Tables 11 through 17 cover BPPD actions.

Table 11—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Active Ingredients

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
B580	103	New active ingredient; food use; petition to establish a tolerance	19	48,621
B590	104	New active ingredient; food use; petition to establish a tolerance exemption	17	30,390
B600	105	New active ingredient; non-food use	13	18,234
B610	106	New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption	10	12,156
B611	107	New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption	12	12,156
B612	108	New active ingredient; no change to a permanent tolerance exemption	10	16,714
B613	109	New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption	11	16,714
B620	110	New active ingredient; Experimental Use Permit application; non-food use including crop destruct	7	6,079

Table 12—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Active Ingredients

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
B630	111	First food use; petition to establish a tolerance exemption	13	12,156
B631	112	New food use; petition to amend an established tolerance	12	12,156
B640	113	New food use; petition to amend an established tolerance	19	18,234
B643	114	New food use; petition to amend tolerance exemption	10	12,156
B642	115	First food use; indoor; food/food handling	12	30,390
B644	116	New use, no change to an established tolerance or tolerance exemption	8	12,156
B650	117	New use; non-food	7	6,079

Table 13—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Products

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
B652	118	New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply	13	12,156
B660	119	New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated	4	1,217
B670	120	New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply	7	4,863
B671	121	New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: (1) Submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply	17	12,156
B672	122	New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply	13	8,683
B673	123	New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product	10	4,863
B674	124	New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only	4	1,217
B675	125	New product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only	10	8,683
B676	126	New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: (1) Submission of product-specific data, and (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply	13	8,683
B677	127	New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • animal safety studies and/or • child resistant packaging	10	8,400

Table 14—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; Amendments

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
B621	128	Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption	7	4,863
B622	129	Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption	11	12,156
B641	130	Amendment of an established tolerance or tolerance exemption	13	12,156
B680	131	Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission	5	4,863
B681	132	Amendment; unregistered source of active ingredient(s). Requires data submission	7	5,789
B683	133	Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI)	6	4,863
B684	134	Amending non-food animal product that includes submission of target animal safety data; previously registered	8	8,400

Table 15—Biopesticides and Pollution Prevention Division—Straight Chain Lepidopteran Pheromones (SCLPS)

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
B690	135	New active ingredient; food or non-food use	7	2,432
B700	136	Experimental Use Permit application; new active ingredient or new use	7	1,217
B701	137	Extend or amend Experimental Use Permit	4	1,217
B710	138	New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix	4	1,217
B720	139	New product; registered source of active ingredient(s); requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply	5	1,217
B721	140	New product; unregistered source of active ingredient	7	2,548
B722	141	New use and/or amendment; petition to establish a tolerance or tolerance exemption	7	2,359
B730	142	Label amendment requiring data submission	5	1,217

Table 16—Biopesticides and Pollution Prevention Division—Other Actions

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
B614	143	Conditional ruling on pre-application study waivers; applicant-initiated	3	2,409
B615	144	Rebuttal of agency reviewed protocol, applicant-initiated	3	2,409
B682	145	Protocol review; applicant-initiated; excludes time for HSRB review	3	2,316

Table 17—Biopesticides and Pollution Prevention Division—Plant Incorporated Protectants (PIPS)

EPA No.	New CR No.	Action	Decision review time (months)	FY '14/15 registration service fee ($)
B740	146	Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: 1. non-food/feed use(s) for a new or registered PIP; 2. food/feed use(s) for a new or registered PIP with crop destruct; 3. food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s)	6	91,165
B750	147	Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered PIP	9	121,552
B770	148	Experimental Use Permit application; new PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review	15	182,327
B771	149	Experimental Use Permit application; new PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows	10	121,552
B772	150	Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected	3	12,156
B773	151	Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient	5	30,390
B780	152	Registration application; new PIP; non-food/feed	12	151,940
B790	153	Registration application; new PIP; non-food/feed; SAP review	18	212,715
B800	154	Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption	12	243,165
B810	155	Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review	18	303,878
B820	156	Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient	15	303,878
B840	157	Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review	21	364,653
B851	158	Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s)	9	121,552
B870	159	Registration application; registered PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s)	9	36,466
B880	160	Registration application; registered PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s)	9	30,390
B881	161	Registration application; registered PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). SAP review	15	91,165
B883	162	Registration application; new PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption	9	121,552
B884	163	Registration application; new PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient	12	151,940
B885	164	Registration application; registered PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s)	9	91,165
B890	165	Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s)	9	60,777
B891	166	Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s), SAP review	15	121,552
B900	167	Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled	6	12,156
B901	168	Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review	12	72,931
B902	169	PIP Protocol review	3	6,079
B903	170	Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD	6	60,777
B904	171	Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient)	9	121,552

Table 18—Inert Ingredients, External Review and Miscellaneous Actions

EPA No.	New CR No.	Action	Decision review time (months)	FY'14/15 registration service fee ($)
I001	172	Approval of new food use inert ingredient	12	18,900
I002	173	Amend currently approved inert ingredient tolerance or exemption from tolerance; new data	10	5,250
I003	174	Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data	8	3,150
I004	175	Approval of new non-food use inert ingredient	8	10,500
I005	176	Amend currently approved non-food use inert ingredient with new use pattern; new data	8	5,250
I006	177	Amend currently approved non-food use inert ingredient with new use pattern; no new data	6	3,150
I007	178	Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern	4	1,575
I008	179	Approval of new polymer inert ingredient, food use	5	3,570
I009	180	Approval of new polymer inert ingredient, non-food use	4	2,940
I010	181	Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data	6	1,575
M001	182	Study protocol requiring Human Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient	9	7,560
M002	183	Completed study requiring Human Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient	9	7,560
M003	184	External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant-initiated request based on a requirement of the Administrator, as defined by FIFRA section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients	12	60,900
M004	185	External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant-initiated request based on a requirement of the Administrator, as defined by FIFRA section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients	18	60,900
M005	186	New product: combination, contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product	9	21,000
M006	187	Request for up to 5 letters of certification (Gold Seal) for one actively registered product	1	263
M007	188	Request to extend Exclusive Use of data as provided by FIFRA section 3(c)(1)(F)(ii)	12	5,250
M008	189	Request to grant Exclusive Use of data as provided by FIFRA section 3(c)(1)(F)(vi) for a minor use, when a FIFRA section 2(ll)(2) determination is required	10	1,575

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. 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 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 Web site www.pay.gov.

1. From the pay.gov home page, under “Find Public Forms.”

2. Select “search by Agency name.”

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

4. Select “Environmental Protection Agency.”

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

6. Complete the form entering the PRIA fee category and fee.

7. 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 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:

• 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.
• 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 VII. 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% 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 email if EPA has either an email address on file or an email address is provided on the application.

VII. Addresses for Applications

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

• By U.S. Postal Service mail. Document Processing Desk (REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460-0001.
• 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: September 18, 2013.

Martha Monell,

Acting Director, Office of Pesticide Programs.