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Pesticide Registration Improvement Renewal Act (PRIA 2)
Tables - FY 2009/FY 2010 Fee Schedule for Registration Applications
The following PRIA fee schedule tables were published in the Federal Register of August 5, 2008 (Volume 73, Number 151) Page 45438-45450 and apply to pesticide registration applications received by the Agency on October 1, 2008 through September 30, 2010.
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 140 categories spread across the 3 Divisions. There are 58 RD categories, 27 AD categories, and 55 BPPD categories. For tracking purposes, OPP has assigned a 3-digit identifier to each category, beginning with RD categories, followed by AD and BPPD categories. The categories are prefaced with a letter designation indicating which Division of OPP is responsible for applications in that category (R= Registration Division, A=Antimicrobials Division, B=Biopesticides and Pollution Prevention Division). 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 Years 2009 and 2010. The 2010 decision times apply to 2011 and 2012. The decision review periods in the tables are based upon EPA fiscal years (FY), which run from October 1 through September 30.
- The column entitled "FY 09/FY 10 Registration Service Fee ($)" lists the registration service fee for the action for fiscal year 2009 (October 1, 2008 through September 30, 2009) and fiscal year 2010 (October 1, 2009 through September 30, 2010).
- The following acronyms are used in some of the tables:
- DART - Dose Adequacy Response Team
- DNT - Developmental Neurotoxicity
- HSRB - Human Studies Review Board
- GW/SW - Ground Water/Surface Water
- PHI - Pre-Harvest Interval
- PPE - Personal Protective Equipment
- REI - Restricted Entry Interval
- SAP - FIFRA Scientific Advisory Panel
Fee Schedule Tables - Effective October 1, 2008
- A. Registration Division
- B. Antimicrobials Division
- C. Biopesticides and Pollution Prevention Division
A. Registration Division (RD)
The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed "conventional chemicals," excluding pesticides intended for antimicrobial uses. The term "conventional chemical" is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic origin, synthetic chemicals that are identical to naturally-occurring chemicals and microbial pesticides. Tables 1 through 5 cover RD actions.
TABLE 1. REGISTRATION DIVISION–NEW ACTIVE INGREDIENTS
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| R010 | 1 | Food use1 | 24 | 24 | 542,115 |
| R020 | 2 | Food use; reduced risk1 | 18 | 18 | 542,115 |
| R030 | 3 | Food use; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit and temporary tolerance same as #R0401 | 24 | 24 | 599,235 |
| R040 | 4 | Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit $326,025 toward new active ingredient application that follows | 18 | 18 | 399,525 |
| R050 | 5 | Food use; application submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit and temporary tolerance are granted1 | 14 | 14 | 199,815 |
| R060 | 6 | Non-food use; outdoor1 | 21 | 21 | 376,635 |
| R070 | 7 | Non-food use; outdoor; reduced risk1 | 16 | 16 | 376,635 |
| R080 | 8 | Non-food use; outdoor; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit same as #R0901 | 21 | 21 | 416,640 |
| R090 | 9 | Non-food use; outdoor; Experimental Use Permit application submitted before application for registration; credit $228,225 toward new active ingredient application that follows | 16 | 16 | 279,615 |
| R100 | 10 | Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit is granted 1 | 12 | 12 | 137,025 |
| R110 | 11 | Non-food use; indoor1 | 20 | 20 | 209,475 |
| R120 | 12 | Non-food use; indoor; reduced risk1 | 14 | 14 | 209,475 |
| R121 | 13 | Non-food use; indoor; Experimental Use Permit application submitted before application for registration; credit $100,000 toward new active ingredient application that follows | 18 | 18 | 157,500 |
| R122 | 14 | Enriched isomer(s) of registered mixed-isomer active ingredient1 | 18 | 18 | 273,945 |
| R123 | 15 | Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities1 | 18 | 18 | 407,610 |
| R124 | 16 | Conditional Ruling on Preapplication Study Waivers; applicant-initiated | 6 | 6 | 2,184 |
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 2. REGISTRATION DIVISION–NEW USES
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| R130 | 17 | First food use; indoor; food/food handling1 | 21 | 21 | 165,375 |
| R140 | 18 | Additional food use; Indoor; food/food handling | 15 | 15 | 38,588 |
| R150 | 19 | First food use1 | 21 | 21 | 228,270 |
| R160 | 20 | First food use; reduced risk1 | 16 | 16 | 228,270 |
| R170 | 21 | Additional food use | 15 | 15 | 57,120 |
| R180 | 22 | Additional food use; reduced risk | 10 | 10 | 57,120 |
| R190 | 23 | Additional food uses; 6 or more submitted in one application | 15 | 15 | 342,720 |
| R200 | 24 | Additional food uses; 6 or more submitted in one application; reduced risk | 10 | 10 | 342,720 |
| R210 | 25 | Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration | 12 | 12 | 42,315 |
| R220 | 26 | Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration | 6 | 6 | 17,136 |
| R230 | 27 | Additional use; non-food; outdoor | 15 | 15 | 22,827 |
| R240 | 28 | Additional use; non-food; outdoor; reduced risk | 10 | 10 | 22,827 |
| R250 | 29 | Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration | 6 | 6 | 17,136 |
| R260 | 30 | New use; non-food; indoor | 12 | 12 | 11,025 |
| R270 | 31 | New use; non-food; indoor; reduced risk | 9 | 9 | 11,025 |
| R271 | 32 | New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration | 6 | 6 | 8,400 |
| R272 | 33 | Review of Study Protocol; applicant-initiated; excludes DART, pre-registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review | 3 | 3 | 2,184 |
| R273 | 34 | Additional use; seed treatment; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses | 12 | 12 | 43,575 |
| R274 | 35 | Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses | 12 | 12 | 261,450 |
1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 3. REGISTRATION DIVISION–IMPORT AND OTHER TOLERANCES
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| R280 | 36 | Establish import tolerance; new active ingredient or first food use1 | 21 | 21 | 275,625 |
| R290 | 37 | Establish import tolerance; additional food use | 15 | 15 | 55,125 |
| R291 | 38 | Establish import tolerances; additional food uses; 6 or more crops submitted in one petition | 15 | 15 | 330,750 |
| R292 | 39 | Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated | 10 | 10 | 39,165 |
| R293 | 40 | Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated | 12 | 12 | 46,200 |
| R294 | 41 | Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated | 12 | 12 | 277,200 |
| R295 | 42 | Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated | 15 | 15 | 57,120 |
| R296 | 43 | Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated | 15 | 15 | 342,720 |
1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 4. REGISTRATION DIVISION–NEW PRODUCTS
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| R300 | 44 | New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. | 3 | 3 | 1,365 |
| R301 | 45 | New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. | 4 | 4 | 1,638 |
| R310 | 46 | New end-use or manufacturing-use product; requires review of data package within RD; includes reviews and/or waivers of data for only:
|
6 | 6 | 4,578 |
| R311 | 49 | New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners | 12 | 12 | 16,317 |
| R312 | 50 | New product; requires approval of new non-food-use inert; applicant-initiated | 6 | 6 | 8,715 |
| R313 | 51 | New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated | 10 | 10 | 11,991 |
| R320 | 47 | New product; new physical form; requires data review in science divisions | 12 | 12 | 11,424 |
| R330 | 48 | New manufacturing-use product; registered active ingredient; selective data citation | 12 | 12 | 17,136 |
| R331 | 52 | New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only | 3 | 3 | 2,184 |
| R332 | 53 | New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only | 24 | 24 | 244,650 |
TABLE 5. REGISTRATION DIVISION–AMENDMENTS TO REGISTRATION
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| R340 | 54 | Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient)1 | 4 | 4 | 3,444 |
| R350 | 55 | Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement)1 | 8 | 8 | 11,424 |
| R370 | 56 | Cancer reassessment; applicant-initiated | 18 | 18 | 171,255 |
| R371 | 57 | Amendment to Experimental Use Permit; requires data review / risk assessment | 6 | 6 | 8,715 |
| R372 | 58 | Refined ecological and/or endangered species assessment; applicant-initiated | 18 | 12 | 163,065 |
1EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
B. Antimicrobials Division (AD)
The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 6 through 8 cover AD actions.
TABLE 6. ANTIMICROBIALS DIVISION–NEW ACTIVE INGREDIENTS
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| A380 | 59 | Food use; establish tolerance exemption1 | 24 | 24 | 99,225 |
| A390 | 60 | Food use; establish tolerance1 | 24 | 24 | 165,375 |
| A400 | 61 | Non-food use; outdoor; FIFRA §2(mm) uses1 | 18 | 18 | 82,688 |
| A410 | 62 | Non-food use; outdoor; uses other than FIFRA §2(mm)1 | 21 | 21 | 165,375 |
| A420 | 63 | Non-food use; indoor; FIFRA §2(mm) uses1 | 18 | 18 | 55,125 |
| A430 | 64 | Non-food use; indoor; uses other than FIFRA §2(mm) 1 | 20 | 20 | 82,688 |
| A431 | 65 | Non-food use; indoor; low-risk and low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol | 12 | 12 | 57,750 |
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 7. ANTIMICROBIALS DIVISION–NEW USES
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| A440 | 66 | First food use; establish tolerance exemption1 | 21 | 21 | 27,563 |
| A450 | 67 | First food use; establish tolerance 1 | 21 | 21 | 82,688 |
| A460 | 68 | Additional food use; establish tolerance exemption | 15 | 15 | 11,025 |
| A470 | 69 | Additional food use; establish tolerance | 15 | 15 | 27,563 |
| A480 | 70 | Additional use; non-food; outdoor; FIFRA §2(mm) uses | 9 | 9 | 16,538 |
| A490 | 71 | Additional use; non-food; outdoor; uses other than FIFRA §2(mm) | 15 | 15 | 27,563 |
| A500 | 72 | Additional use; non-food; indoor; FIFRA §2(mm) uses | 9 | 9 | 11,025 |
| A510 | 73 | Additional use; non-food; indoor; uses other than FIFRA §2(mm) | 12 | 12 | 11,025 |
| A520 | 74 | Experimental Use Permit application | 9 | 9 | 5,513 |
| A521 | 75 | Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 | 4 | 3 | 2,100 |
| A522 | 76 | Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2 | 15 | 12 | 10,500 |
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 8. ANTIMICROBIALS DIVISION–NEW PRODUCTS AND AMENDMENTS
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| A530 | 77 | New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. | 3 | 3 | 1,103 |
| A531 | 78 | New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. | 4 | 4 | 1,575 |
| A532 | 85 | New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted | 4 | 4 | 4,410 |
| A540 | 79 | New end use product; FIFRA §2(mm) uses only | 4 | 4 | 4,410 |
| A550 | 80 | New end-use product; uses other than FIFRA §2(mm); non-FQPA product | 6 | 6 | 4,410 |
| A560 | 81 | New manufacturing-use product; registered active ingredient; selective data citation | 12 | 12 | 16,538 |
| A570 | 82 | Label amendment requiring data submission 1 | 4 | 4 | 3,308 |
| A571 | 83 | Cancer reassessment; applicant-initiated | 18 | 18 | 82,688 |
| A572 | 84 | Refined ecological risk and/or endangered species assessment; applicant-initiated | 18 | 12 | 78,750 |
1EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
C. Biopesticides and Pollution Prevention Division (BPPD)
The Biopesticides and Pollution Prevention Division of OPP is responsible for the processing of pesticide applications for biochemical pesticides, microbial pesticides, and plant-incorporated protectants (PIPs).
The fee tables for BPPD tables are presented by type of pesticide rather than by type of action: Microbial and biochemical pesticides, straight chain lepidopteran pheromones (SCLPs), and PIPs. Within each table, the types of application are the same as those in other divisions and use the same terminology as in Unit III. Tables 9 through 11 cover BPPD actions.
TABLE 9. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION–MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS AND AMENDMENTS
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| B580 | 86 | New active ingredient; food use; establish tolerance1 | 18 | 18 | 44,100 |
| B590 | 87 | New active ingredient; food use; establish tolerance exemption 1 | 16 | 16 | 27,563 |
| B600 | 88 | New active ingredient; non-food use1 | 12 | 12 | 16,538 |
| B610 | 89 | Food use; Experimental Use Permit application; establish temporary tolerance exemption | 9 | 9 | 11,025 |
| B620 | 90 | Non-food use; Experimental Use Permit application | 6 | 6 | 5,513 |
| B621 | 91 | Extend or amend Experimental Use Permit | 6 | 6 | 4,410 |
| B630 | 92 | First food use; establish tolerance exemption | 12 | 12 | 11,025 |
| B631 | 93 | Amend established tolerance exemption | 9 | 9 | 11,025 |
| B640 | 94 | First food use; establish tolerance 1 | 18 | 18 | 16,538 |
| B641 | 95 | Amend established tolerance (e.g., decrease or increase) | 12 | 12 | 11,025 |
| B650 | 96 | New use; non-food | 6 | 6 | 5,513 |
| B660 | 97 | New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. | 3 | 3 | 1,103 |
| B670 | 98 | New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product specific data or with request for data waivers supported by scientific rationales | 6 | 6 | 4,410 |
| B671 | 99 | New product; food use; unregistered source of active ingredient; requires amendment of established tolerance or tolerance exemption; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales | 16 | 16 | 11,025 |
| B672 | 100 | New product; non-food use or food use having established tolerance or tolerance exemption; unregistered source of active ingredient; no data compensation issues; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales | 12 | 12 | 7,875 |
| B680 | 101 | Label amendment requiring data submission2 | 4 | 4 | 4,410 |
| B681 | 102 | Label amendment; unregistered source of active ingredient; supporting data require scientific review | 6 | 6 | 5,250 |
| B682 | 103 | Protocol review; applicant-initiated; excludes time for HSRB review (pre application) | 3 | 3 | 2,100 |
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
2EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
TABLE 10. BIOPESTICIDES AND POLLUTION PREVENTION DIVISION–STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| B690 | 104 | New active ingredient; food or non-food use 1 | 6 | 6 | 2,205 |
| B700 | 105 | Experimental Use Permit application; new active ingredient or new use | 6 | 6 | 1,103 |
| B701 | 106 | Extend or amend Experimental Use Permit | 3 | 3 | 1,103 |
| B710 | 107 | New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. | 3 | 3 | 1,103 |
| B720 | 108 | New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product specific data or with request for data waivers supported by scientific rationales | 4 | 4 | 1,103 |
| B721 | 109 | New product; unregistered source of active ingredient | 6 | 6 | 2,310 |
| B722 | 110 | New use and/or amendment to tolerance or tolerance exemption | 6 | 6 | 2,310 |
| B730 | 111 | Label amendment requiring data submission 2 | 4 | 4 | 1,103 |
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
2EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
TABLE 11. BIOPESTICIDE AND POLLUTION PREVENTION DIVISION–PLANT INCORPORATED PROTECTANTS (PIPS)
| EPA No. | CR No. | Action | Decision time (months) | FY 09/FY 10 Registration Service Fee ($) | |
|---|---|---|---|---|---|
| FY 09 | FY 10 | ||||
| B740 | 112 | Experimental Use Permit application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review required 1 | 6 | 6 | 82,688 |
| B750 | 113 | Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required 1 | 9 | 9 | 110,250 |
| B760 | 114 | Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct basis; SAP review required; credit $78,750 toward new active ingredient application that follows | 12 | 12 | 137,813 |
| B761 | 115 | Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct; no SAP review required; credit $78,750 toward new active ingredient application that follows | 7 | 7 | 82,688 |
| B770 | 116 | Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; SAP review required; credit $105,000 toward new active ingredient application that follows | 15 | 15 | 165,375 |
| B771 | 117 | Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required; credit $105,000 toward new active ingredient application that follows | 10 | 10 | 110,250 |
| B772 | 118 | Amend or extend Experimental Use Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected | 3 | 3 | 11,025 |
| B773 | 119 | Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption | 5 | 5 | 27,563 |
| B860 | 120 | Amend Experimental Use Permit; first food use or major revision of experimental design | 6 | 6 | 11,025 |
| B780 | 121 | New active ingredient; non-food/feed; no SAP review required 2 | 12 | 12 | 137,813 |
| B790 | 122 | New active ingredient; Non-food/feed; SAP review required 2 | 18 | 18 | 192,938 |
| B800 | 123 | New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required2 | 12 | 12 | 220,500 |
| B810 | 124 | New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP review required2 | 18 | 18 | 275,625 |
| B820 | 125 | New active ingredient; establish tolerance or tolerance exemption; no SAP review required 2 | 15 | 15 | 275,625 |
| B840 | 126 | New active ingredient; establish tolerance or tolerance exemption; SAP review required2 | 21 | 21 | 330,750 |
| B830 | 127 | New active ingredient; Experimental Use Permit application submitted simultaneously; establish tolerance or tolerance exemption; no SAP review required 2 | 15 | 15 | 330,750 |
| B850 | 128 | New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required2 | 21 | 21 | 385,875 |
| B851 | 129 | New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; no SAP review required | 9 | 9 | 110,250 |
| B852 | 130 | New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; SAP review required | 9 | 9 | 165,375 |
| B870 | 131 | New use 1 | 9 | 9 | 33,075 |
| B880 | 132 | New product; no SAP review required3 | 9 | 9 | 27,563 |
| B881 | 133 | New product; SAP review required3 | 15 | 15 | 82,688 |
| B890 | 134 | Amendment; seed production to commercial registration; no SAP review required | 9 | 9 | 55,125 |
| B891 | 135 | Amendment; seed production to commercial registration; SAP review required | 15 | 15 | 110,250 |
| B900 | 136 | Amendment (except #B890); No SAP review required; (e.g., new IRM requirements that are applicant initiated; or amending a conditional registration to extend the registration expiration date with additional data submitted)4 | 6 | 6 | 11,025 |
| B901 | 137 | Amendment (except #B890); SAP review required4 | 12 | 12 | 66,150 |
| B902 | 138 | PIP Protocol review | 3 | 3 | 5,513 |
| B903 | 139 | Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD | 6 | 6 | 55,125 |
| B904 | 140 | Import tolerance or tolerance exemption; processed commodities/food only | 9 | 9 | 110,250 |
1Example: Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
2May be either a registration for seed increase or a full commercial registration. If a seed increase registration is granted first, full commercial registration is obtained using B890.
3Example: Stacking PIP traits within a crop using traditional breeding techniques.
4EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.