Pesticide Registration Improvement Extension Act (PRIA 3)
Tables - FY 2013 Fee Schedule for Registration Applications

The following PRIA fee schedule tables were included in the Pesticide Registration Improvement Extension Act (PRIA 3) Bill and apply to pesticide registration applications received by the Agency on October 1, 2012 through September 30, 2013.

Fee Schedule Tables - Effective October 1, 2012

A. Registration Division
B. Antimicrobials Division
C. Biopesticides and Pollution Prevention Division
D. Inerts
E. Miscellaneous Actions

How to Read the PRIA Fee Tables

Each table consists of the following columns:

The column entitled "EPA No." assigns an EPA identifier to each fee category. There are 189 categories spread across the 3 Divisions, inerts and miscellaneous actions. 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=Inerts and M=Miscellaneous). A detailed explanation of the type of application that falls under a fee category is linked to the fee category number. When accessed, the link will go to the appropriate page of the Fee Determination Decision Tree with the fee category interpretation.
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." Further information may be obtained by accessing the link provided with the fee category in the first column.
The column entitled "Decision Time" lists the decision times in months for each type of action for Fiscal Year 2013. The 2013 decision times apply to 2013. 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 13 Registration Service Fee ($)" lists the registration service fee for the action for fiscal year 2013 (October 1, 2012 through September 30, 2013).

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

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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 cover RD actions.

TABLE 1. REGISTRATION DIVISION–NEW ACTIVE INGREDIENTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
R010	1	New Active Ingredient, Food use ⁽²⁾ ⁽³⁾	24	569,221
R020	2	New Active Ingredient, Food use; reduced risk ⁽²⁾ ⁽³⁾	18	569,221
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 ⁽³⁾	18	419,502
R060	4	New Active Ingredient, Non-food use; outdoor ⁽²⁾ ⁽³⁾	21	395,467
R070	5	New Active Ingredient, Non-food use; outdoor; reduced risk ⁽²⁾ ⁽³⁾	16	395,467
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 ⁽³⁾	16	293,596
R110	7	New Active Ingredient, Non-food use; indoor ⁽²⁾ ⁽³⁾	20	219,949
R120	8	New Active Ingredient, Non-food use; indoor; reduced risk ⁽²⁾ ⁽³⁾	14	219,949
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 ⁽³⁾	18	165,375
R122	10	Enriched isomer(s) of registered mixed-isomer active ingredient ⁽²⁾ ⁽³⁾	18	287,643
R123	11	New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities ⁽²⁾ ⁽³⁾	18	427,991
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 ⁽³⁾	16	293,596

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

²All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

³Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

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TABLE 2. REGISTRATION DIVISION–NEW USES

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
R130	13	First food use; indoor; food/food handling ⁽²⁾ ⁽³⁾	21	173,644
R140	14	Additional food use; Indoor; food/food handling ⁽³⁾ ⁽⁴⁾	15	40,518
R150	15	First food use ⁽²⁾ ⁽³⁾	21	239,684
R160	16	First food use; reduced risk ⁽²⁾ ⁽³⁾	16	239,684
R170	17	Additional food use ⁽³⁾ ⁽⁴⁾	15	59,976
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. ⁽³⁾ ⁽⁴⁾	10	59,976
R180	19	Additional food use; reduced risk ⁽³⁾ ⁽⁴⁾	10	59,976
R190	20	Additional food uses; 6 or more submitted in one application ⁽³⁾ ⁽⁴⁾	15	359,856
R200	21	Additional Food Use; 6 or more submitted in one application; Reduced Risk ⁽³⁾ ⁽⁴⁾	10	359,856
R210	22	Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration ⁽³⁾ ⁽⁴⁾	12	44,431
R220	23	Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration ⁽³⁾ ⁽⁴⁾	6	17,993
R230	24	Additional use; non-food; outdoor ⁽³⁾ ⁽⁴⁾	15	23,969
R240	25	Additional use; non-food; outdoor; reduced risk ⁽³⁾ ⁽⁴⁾	10	23,969
R250	26	Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration ⁽³⁾ ⁽⁴⁾	6	17,993
R251	27	Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis ⁽³⁾	8	17,993
R260	28	New use; non-food; indoor ⁽³⁾ ⁽⁴⁾	12	11,577
R270	29	New use; non-food; indoor; reduced risk ⁽³⁾ ⁽⁴⁾	9	11,577
R271	30	New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration ⁽³⁾ ⁽⁴⁾	6	8,820
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 ⁽³⁾ ⁽⁴⁾	12	45,754
R274	32	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 ⁽³⁾ ⁽⁴⁾	12	274,523

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

⁴Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

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TABLE 3. REGISTRATION DIVISION–IMPORT AND OTHER TOLERANCES

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
R280	33	Establish import tolerance; new active ingredient or first food use ⁽²⁾	21	289,407
R290	34	Establish Import tolerance; Additional new food use	15	57,882
R291	35	Establish import tolerances; additional food uses; 6 or more crops submitted in one petition	15	347,288
R292	36	Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated	11	41,124
R293	37	Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated	12	48,510
R294	38	Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated	12	291,060
R295	39	Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated	15	59,976
R296	40	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
R297	41	Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated	11	246,744
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) ⁽³⁾	13	53,120
R299	43	Amend 6 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) ⁽³⁾	13	258,740

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

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TABLE 4. REGISTRATION DIVISION–NEW PRODUCTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 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% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. ⁽²⁾ ⁽³⁾	4	1,434
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. ⁽²⁾ ⁽³⁾	4	1,720
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. ⁽²⁾ ⁽³⁾	7	4,807
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 ublic health pest efficacy and/or child resistant packaging. ⁽²⁾ ⁽³⁾	8	6,009
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 ⁽²⁾ ⁽³⁾	9	8,000
R320	49	New product; new physical form; requires data review in science divisions ⁽²⁾ ⁽³⁾	12	11,996
R331	50	New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only ⁽²⁾ ⁽³⁾	3	2,294
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 ⁽²⁾ ⁽³⁾	24	256,883
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. ⁽²⁾ ⁽³⁾	10	17,993
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. ⁽²⁾ ⁽³⁾	11	17,993

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

²An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

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TABLE 5. REGISTRATION DIVISION–AMENDMENTS TO REGISTRATION

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
R340	54	Amendment requiring data review within RD (e.g., changes to precautionary label statements) ⁽²⁾ ⁽³⁾	4	3,617
R345	55	Amending non-food animal product that includes submission of target animal safety data; previously registered ⁽²⁾ ⁽³⁾	7	8,000
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) ⁽²⁾ ⁽³⁾	9	11,996
R351	57	Amendment adding a new unregistered source of active ingredient. ⁽²⁾ ⁽³⁾	8	11,996
R352	58	Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data ⁽²⁾ ⁽³⁾	8	11,996
R371	59	Amendment to Experimental Use Permit; (does not include extending a permit's time period) ⁽³⁾	6	9,151

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

²(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

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TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
R124	60	Conditional Ruling on Preapplication Study Waivers; applicant-initiated	6	2,294
R272	61	Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review	3	2,294
R275	62	Rebuttal of agency reviewed protocol, applicant initiated	3	2,294
R370	63	Cancer reassessment; applicant-initiated	18	179,818

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

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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 8 cover AD actions.

TABLE 7. ANTIMICROBIALS DIVISION–NEW ACTIVE INGREDIENTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
A380	64	New Active Ingredient Food use, establish tolerance exemption ⁽²⁾ ⁽³⁾	24	104,187
A390	65	New Active Ingredient Food use, establish tolerance ⁽²⁾ ⁽³⁾	24	173,644
A400	66	New Active Ingredient, Non-food use, outdoor, FIFRA §2(mm) uses ⁽²⁾ ⁽³⁾	18	86,823
A410	67	New Active Ingredient Non-food use, outdoor, uses other than FIFRA §2(mm) ⁽²⁾ ⁽³⁾	21	173,644
A420	68	New Active Ingredient Non-food use, indoor, FIFRA §2(mm) uses ⁽²⁾ ⁽³⁾	18	57,882
A430	69	New Active Ingredient, Non-Food Use Indoor, uses other than FIFRA §2(mm) uses ⁽²⁾ ⁽³⁾	20	86,823
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 ⁽²⁾ ⁽³⁾	12	60,638

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

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TABLE 8. ANTIMICROBIALS DIVISION–NEW USES

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
A440	71	New Use, First Food Use, establish tolerance exemption ⁽²⁾ ⁽³⁾ ⁽⁴⁾	21	28,942
A450	72	New use, First food use, establish tolerance ⁽²⁾ ⁽³⁾ ⁽⁴⁾	21	86,823
A460	73	New use, additional food use; establish tolerance exemption ⁽³⁾ ⁽⁴⁾ ⁽⁵⁾	15	11,577
A470	74	New use, additional food use, establish tolerance ⁽³⁾ ⁽⁴⁾ ⁽⁵⁾	15	28,942
A471	75	Additional food uses; establish tolerances; 6 or more submitted in one application ⁽³⁾ ⁽⁴⁾ ⁽⁵⁾	15	173,652
A480	76	New use, Additional use, non-food, outdoor; FIFRA §2(mm) uses ⁽⁴⁾ ⁽⁵⁾	9	17,365
A481	77	Additional non-food outdoor uses; FIFRA §2(mm) uses; 6 or more submitted in one application ⁽⁴⁾ ⁽⁵⁾	9	104,190
A490	78	New use, additional use, non-food, outdoor, uses other than FIFRA §2(mm) ⁽⁴⁾ ⁽⁵⁾	15	28,942
A491	79	Additional non-food; outdoor; uses other than FIFRA §2(mm); 6 or more submitted in one application ⁽⁴⁾ ⁽⁵⁾	15	173,652
A500	80	New use, additional use, non-food, indoor FIFRA §2(mm) uses ⁽⁴⁾ ⁽⁵⁾	9	11,577
A501	81	Additional non-food; indoor; FIFRA §2(mm) uses; 6 or more submitted in one application ⁽⁴⁾ ⁽⁵⁾	9	69,462
A510	82	New use, additional use, non-food, indoor, other than FIFRA §2(mm) ⁽⁴⁾ ⁽⁵⁾	12	11,577
A511	83	Additional non-food; indoor; uses other than FIFRA §2(mm); 6 or more submitted in one application ⁽⁴⁾ ⁽⁵⁾	12	69,462

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

³If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.

⁴Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

⁵Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

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TABLE 9. ANTIMICROBIALS DIVISION–NEW PRODUCTS AND AMENDMENTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 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. ⁽²⁾ ⁽³⁾	4	1,159
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. ⁽²⁾ ⁽³⁾	4	1,654
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 ⁽²⁾ ⁽³⁾	5	4,631
A540	87	New end use product; FIFRA §2(mm) uses only ⁽²⁾ ⁽³⁾	5	4,631
A550	88	New end-use product; uses other than FIFRA §2(mm); non-FQPA product ⁽²⁾ ⁽³⁾	7	4,631
A560	89	New manufacturing use product; registered active ingredient; selective data citation ⁽²⁾ ⁽³⁾	12	17,365
A570	90	Label amendment requiring data review ⁽³⁾ ⁽⁴⁾	4	3,474
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) ⁽²⁾ ⁽³⁾ ⁽⁴⁾	9	11,996

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

⁴(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

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TABLE 10. ANTIMICROBIALS DIVISION-EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
A520	92	Experimental Use Permit application ⁽²⁾	9	5,789
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	2,250
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	11,025
A524	95	New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. ⁽²⁾	18	138,916
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. ⁽²⁾	18	83,594
A526	97	New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. ⁽²⁾	15	86,823
A527	98	New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. ⁽²⁾	15	58,000
A528	99	Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption ⁽²⁾	15	20,260
A529	100	Amendment to Experimental Use Permit; requires data review or risk assessment ⁽²⁾	9	10,365
A523	101	Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols)	9	11,025
A571	102	Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated.	18	86,823

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

²Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

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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 9 through 11 cover BPPD actions.

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TABLE 11. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
B580	103	New active ingredient; food use; petition to establish a tolerance ⁽²⁾	19	46,305
B590	104	New active ingredient; food use; petition to establish a tolerance exemption ⁽²⁾	17	28,942
B600	105	New active ingredient; non-food use ⁽²⁾	13	17,365
B610	106	New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption	10	11,577
B611	107	New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption	12	11,577
B612	108	New active ingredient; no change to a permanent tolerance exemption ⁽²⁾	10	15,918
B613	109	New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption ⁽²⁾	11	15,918
B620	110	New active ingredient; Experimental Use Permit application; non-food use including crop destruct	7	5,789

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

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TABLE 12. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
B630	111	First food use; petition to establish a tolerance exemption ⁽²⁾	13	11,577
B631	112	New food use; petition to amend an established tolerance ⁽³⁾	12	11,577
B640	113	New food use; petition to amend an established tolerance ⁽²⁾	19	17,365
B643	114	New Food use; petition to amend tolerance exemption ⁽³⁾	10	11,577
B642	115	First food use; indoor; food/food handling ⁽²⁾	12	28,942
B644	116	New use, no change to an established tolerance or tolerance exemption ⁽³⁾	8	11,577
B650	117	New use; non-food ⁽³⁾	7	5,789

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

³Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

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TABLE 13. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 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 ⁽²⁾	13	11,577
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. ⁽²⁾	4	1,159
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. ⁽²⁾	7	4,631
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. ⁽²⁾	17	11,577
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. ⁽²⁾	13	8,269
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. ⁽²⁾	10	4,631
B674	124	New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only ⁽²⁾	4	1,159
B675	125	New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. ⁽²⁾	10	8,269
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. ⁽²⁾	13	8,269
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 ⁽²⁾	10	8,000

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

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TABLE 14. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
B621	128	Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption.	7	4,631
B622	129	Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption.	11	11,577
B641	130	Amendment of an established tolerance or tolerance exemption.	13	11,577
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. ⁽²⁾	5	4,631
B681	132	Amendment; unregistered source of active ingredient(s). Requires data submission. ⁽²⁾	7	5,513
B683	133	Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). ⁽²⁾	6	4,631
B684	134	Amending non-food animal product that includes submission of target animal safety data; previously registered ⁽²⁾	8	8,000

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

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TABLE 15. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
B690	135	New active ingredient; food or non-food use. ⁽²⁾	7	2,316
B700	136	Experimental Use Permit application; new active ingredient or new use.	7	1,159
B701	137	Extend or amend Experimental Use Permit.	4	1,159
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. ⁽³⁾	4	1,159
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. ⁽³⁾	5	1,159
B721	140	New product; unregistered source of active ingredient. ⁽³⁾	7	2,426
B722	141	New use and/or amendment; petition to establish a tolerance or tolerance exemption. ⁽⁴⁾ ⁽⁵⁾	7	2,426
B730	142	Label amendment requiring data submission. ⁽⁴⁾	5	1,159

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

³An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

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TABLE 16. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — OTHER ACTIONS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
B614	143	Conditional Ruling on Preapplication Study Waivers; applicant-initiated	3	2,294
B615	144	Rebuttal of agency reviewed protocol, applicant initiated	3	2,294
B682	145	Protocol review; applicant initiated; excludes time for HSRB review	3	2,205

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

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TABLE 17. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
B740	146	Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: non-food/feed use(s) for a new ⁽²⁾ or registered ⁽³⁾ PIP; food/feed use(s) for a new or registered PIP with crop destruct; food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). ⁽⁴⁾	6	86,823
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 ⁽³⁾ PIP. ⁽⁴⁾	9	115,763
B770	148	Experimental Use Permit application; new ⁽²⁾ 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. ⁽⁵⁾	15	173,644
B771	149	Experimental Use Permit application; new ⁽²⁾ 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	115,763
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	11,577
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	28,942
B780	152	Registration application; new ⁽²⁾ PIP; non-food/feed.	12	144,704
B790	153	Registration application; new ⁽²⁾ PIP; non-food/feed; SAP review. ⁽⁵⁾	18	202,585
B800	154	Registration application; new ⁽²⁾ PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption.	12	231,585
B810	155	Registration application; new ⁽²⁾ PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. ⁽⁵⁾	18	289,407
B820	156	Registration application; new ⁽²⁾ PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient.	15	289,407
B840	157	Registration application; new ⁽²⁾ PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. ⁽⁵⁾	21	347,288
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	115,763
B870	159	Registration application; registered ⁽³⁾ PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). ⁽⁴⁾	9	34,729
B880	160	Registration application; registered ⁽³⁾ 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). ⁽⁶⁾ ⁽⁷⁾	9	28,942
B881	161	Registration application; registered ⁽³⁾ 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. ⁽⁵⁾ ⁽⁶⁾ ⁽⁷⁾	15	86,823
B883	162	Registration application; new ⁽²⁾ 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. ⁽⁸⁾	9	115,763
B884	163	Registration application; new ⁽²⁾ PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. ⁽⁸⁾	12	144,704
B885	164	Registration application; registered ⁽³⁾ 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⁾	9	86,823
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	57,882
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. ⁽⁵⁾	15	115,763
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. ⁽¹⁰⁾ ⁽¹¹⁾	6	11,577
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. ⁽¹⁰⁾ ⁽¹¹⁾	12	69,458
B902	169	PIP Protocol review	3	5,789
B903	170	Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD.	6	57,882
B904	171	Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient).	9	115,763

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

²New PIP = a PIP with an active ingredient that has not been registered.

³Registered PIP = a PIP with an active ingredient that is currently registered.

⁴Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn.

⁵The scientific data involved in this category are complex. EPA often seeks technical advice from the Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed.

⁶Registered PIPs stacked through conventional breeding.

⁷Deployment of a registered PIP with a different IRM plan (e.g., seed blend).

⁸The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category.

⁹Application can be submitted prior to or concurrently with an application for commercial registration.

¹⁰For example, IRM plan modifications that are applicant-initiated.

¹¹EPA-initiated amendments shall not be charged fees.

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TABLE 18. INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'13 Registration Service Fee ($)
I001	172	Approval of new food use inert ingredient ⁽²⁾ ⁽³⁾	12	18,000
I002	173	Amend currently approved inert ingredient tolerance or exemption from tolerance; new data ⁽²⁾	10	5,000
I003	174	Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data ⁽²⁾	8	3,000
I004	175	Approval of new non-food use inert ingredient ⁽²⁾	8	10,000
I005	176	Amend currently approved non-food use inert ingredient with new use pattern; new data ⁽²⁾	8	5,000
I006	177	Amend currently approved non-food use inert ingredient with new use pattern; no new data ⁽²⁾	6	3,000
I007	178	Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern ⁽²⁾	4	1,500
I008	179	Approval of new polymer inert ingredient, food use ⁽²⁾	5	3,400
I009	180	Approval of new polymer inert ingredient, non food use ⁽²⁾	4	2,800
I010	181	Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data ⁽²⁾	6	1,500
M001	182	Study protocol requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient ⁽⁴⁾	9	7,200
M002	183	Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient ⁽⁴⁾	9	7,200
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 § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. ⁽⁵⁾	12	58,000
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 § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. ⁽⁵⁾	18	58,000
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. ⁽⁶⁾ ⁽⁷⁾	9	20,000
M006	187	Request for up to 5 letters of certification (Gold Seal) for one actively registered product.	1	250
M007	188	Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii)	12	5,000
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	1,500

¹A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.

²If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to its respective registration service fee. The decision review time line for both submissions will be the longest of the associated applications. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.

⁴Any other covered application that is associated with and dependent on the HSRB review will be subject to its separate registration service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest review time.

⁵Any other covered application that is associated with and dependent on the SAP review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review.

⁶An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

⁷Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

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Publications | Glossary | A-Z Index | Jobs

Pesticide Registration Improvement Extension Act (PRIA 3) Tables - FY 2013 Fee Schedule for Registration Applications

Fee Schedule Tables - Effective October 1, 2012

How to Read the PRIA Fee Tables

A. Registration Division (RD)

TABLE 1. REGISTRATION DIVISION–NEW ACTIVE INGREDIENTS

TABLE 2. REGISTRATION DIVISION–NEW USES

TABLE 3. REGISTRATION DIVISION–IMPORT AND OTHER TOLERANCES

TABLE 4. REGISTRATION DIVISION–NEW PRODUCTS

TABLE 5. REGISTRATION DIVISION–AMENDMENTS TO REGISTRATION

TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS

B. Antimicrobials Division (AD)

TABLE 7. ANTIMICROBIALS DIVISION–NEW ACTIVE INGREDIENTS

TABLE 8. ANTIMICROBIALS DIVISION–NEW USES

TABLE 9. ANTIMICROBIALS DIVISION–NEW PRODUCTS AND AMENDMENTS

TABLE 10. ANTIMICROBIALS DIVISION-EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS

C. Biopesticides and Pollution Prevention Division (BPPD)

TABLE 11. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS

TABLE 12. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS

TABLE 13. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS

TABLE 14. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS

TABLE 15. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)

TABLE 16. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — OTHER ACTIONS

TABLE 17. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)

TABLE 18. INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS

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Pesticide Registration Improvement Extension Act (PRIA 3)
Tables - FY 2013 Fee Schedule for Registration Applications