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: non-food/feed use(s) for a new ⁽²⁾ or registered ⁽³⁾ PIP ⁽¹²⁾; food/feed use(s) for a new or registered PIP with crop destruct ⁽¹²⁾; 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: 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); 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.