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PRIA Fee Category Table - Biopesticides Division - PIP

Table 17.

EPA No. New CR No. Action Decision Review Time (Months) (1) FY'20 - FY'21 Fees ($)
B740 153 Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes:
  1. non-food/feed use(s) for a new (2) or registered (3) PIP (12);
  2. food/feed use(s) for a new or registered PIP with crop destruct (12);
  3. food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4) (12)
6 100,511
B741 154 (new) Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes:
  1. non-food/feed use(s) for a new (2) or registered (3) PIP;
  2. food/feed use(s) for a new or registered PIP with crop destruct;
  3. food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s);

SAP Review (12)

12 167,515
B750 155 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) (12) 9 134,012
B770 156 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) (12) 15 201,017
B771 157 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.(12) 10 134,012
B772 158 Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. (12) 3 13,403
B773 159 Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. (12) 5 33,506
B780 160 Registration application; new (2) PIP; non-food/feed. (12) 12 167,514
B790 161 Registration application; new (2) PIP; non-food/feed; SAP review. (5) (12) 18 234,519
B800 162 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) 13 180,915
B810 163 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) (12) 19 247,920
B820 164 Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. (12) 15 214,419
B840 165 Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5) (12) 21 281,424
B851 166 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).(12) 9 134,012
B870 167 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) (12) 9 40,205
B880 168 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) (12) 9 33,506
B881 169 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) (12) 15 100,511
B882 170 (new) 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; SAP Review (8) (12) 15 201,017
B883 171 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) (12) 9 134,012
B884 172 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) 12 167,514
B885 173 Registration application; registered (2)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) (12) 6 33,506
B886 174 (new) 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. SAP Review. (8) (12) 18 234,519
B890 175 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). (12) 9 67,007
B891 176 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) (12) 15 134,012
B900 177 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) (12) 6 13,403
B901 178 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) 12 80,407
B902 179 PIP Protocol review 3 6,703
B903 180 Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD. 6 67,007
B904 181 Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient). 9 134,012
B905 182 (new) SAP Review 6 67,007
B906 183 (new) Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients. 3 33,503
B907 184 (new) Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients based on an existing temporary tolerance/tolerance exemption. 3 13,403
B908 185 (new) Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients or inert ingredients 3 46,905

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.

12Where 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.