PRIA Fee Category Table - Biopesticides Division (BPPD) - Plant-Incorporated Protectants (PIP)

Table 17.

EPA No.	New CR No.	Action	Decision Review Time (Months) ⁽¹⁾	FY'27 Fees ($)
B740	159	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; food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). ⁽⁴⁾ ⁽⁵⁾ ⁽¹²⁾	9	151,261
B750	160	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⁾	12	201,678
B771	161	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. ⁽⁵⁾ ⁽¹²⁾	13	201,678
B772	162	Application to amend or extend a PIP Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. ⁽¹²⁾	3	20,172
B773	163	Application to amend or extend a PIP Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. ⁽¹²⁾	9	50,426
B780	164	Registration application; new ⁽²⁾ PIP; non-food/feed or food/feed without tolerance petition based on an existing permanent tolerance exemption. ⁽⁵⁾ ⁽¹²⁾ ⁽¹⁴⁾	16	252,095
B800	165	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. ⁽⁵⁾ ⁽¹²⁾ ⁽¹⁴⁾	17	272,262
B820	166	Registration application; new ⁽²⁾ PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. ⁽⁵⁾ ⁽¹²⁾ ⁽¹⁴⁾	19	322,683
B851	167	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	201,678
B870	168	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⁾ ⁽¹⁴⁾	9	60,508
B880	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). ⁽⁵⁾ ⁽⁶⁾ ⁽⁷⁾ ⁽¹²⁾ ⁽¹⁴⁾	9	50,426
B883	170	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. ⁽⁵⁾ ⁽⁸⁾ ⁽¹²⁾ ⁽¹⁴⁾	13	201,678
B884	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. ⁽⁵⁾ ⁽⁸⁾ ⁽¹²⁾ ⁽¹⁴⁾	19	252,095
B885	172	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	50,426
B890	173	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). ⁽⁵⁾ ⁽¹²⁾ ⁽¹⁴⁾	9	100,841
B900	174	Application to amend a registration, including actions such as modifying an IRM plan, or adding an insect to be controlled. ⁽⁵⁾ ⁽¹⁰⁾ ⁽¹¹⁾ ⁽¹²⁾	6	20,172
B902	175	PIP Protocol review.	3	10,090
B903	176	Inert ingredient permanent tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD.	12	100,841
B904	177	Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient).	12	201,678
B905	178	FIFRA Scientific Advisory Panel Review.	6	100,841
B906	179	Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients.	9	50,421
B907	180	Petition to establish a tolerance exemption for one or more active ingredients based on an existing temporary tolerance/tolerance exemption.	9	20,172
B909	181 (new)	PIP tolerance exemption determination; applicant-initiated; request to determine if an existing tolerance exemption applies to a PIP.	6	20,172
B910	182 (new)	Biotechnology Notification for small scale field testing of genetically engineered microbes.	3	10,090
B921	183 (new)	Experimental Use Permit application; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); non-food/feed. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. Credit 75% of B921 fee toward registration application for the new active ingredient that follows (B922). ⁽⁵⁾ ⁽¹²⁾ ⁽¹³⁾	12	201,678
B922	184 (new)	Registration application; new active ingredient; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); non-food/feed. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. ⁽⁵⁾ ⁽¹²⁾ ⁽¹³⁾ ⁽¹⁴⁾	16	252,095
B923	185 (new)	Experimental Use Permit application; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); with petition to establish a temporary or permanent tolerance/tolerance exemption of an active ingredient. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. Credit 75% of B923 fee toward registration application for the new active ingredient that follows (B924). ⁽⁵⁾ ⁽¹²⁾ ⁽¹³⁾ ⁽¹⁴⁾	15	252,096
B924	186 (new)	Registration application; new active ingredient; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); with petition to establish a permanent tolerance/tolerance exemption of an active ingredient. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. ⁽⁵⁾ ⁽¹²⁾ ⁽¹³⁾ ⁽¹⁴⁾	19	322,683
B925	187 (new)	Experimental Use Permit application; exogenous applications of RNA to elicit the RNA interference pathway in pests; non-food/feed; credit 75% of B925 fee toward registration application for the new active ingredient that follows (B926). ⁽⁵⁾ ⁽¹²⁾	11	30,267
B926	188 (new)	Registration application; new active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; non-food/feed. ⁽⁵⁾ ⁽¹²⁾ ⁽¹⁴⁾	17	90,769
B927	189 (new)	Experimental Use Permit application; exogenous applications of RNA to elicit the RNA interference pathway in pests; with petition to establish a temporary or permanent tolerance/tolerance exemption of an active ingredient; credit 75% of B927 fee toward registration application for the new active ingredient that follows (B928). ⁽⁵⁾ ⁽¹²⁾	14	60,516
B928	190 (new)	Registration application; new active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; with petition to establish a permanent tolerance/tolerance exemption of an active ingredient. ⁽⁵⁾ ⁽¹²⁾ ⁽¹⁴⁾	22	151,275
B929	191 (new)	Registration application; new product, registered active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). ⁽⁵⁾ ⁽¹²⁾	10	8,074
B930	192 (new)	Application to amend or extend a non-PIP Emerging Technologies Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. ⁽¹²⁾	3	20,172
B931	193 (new)	Application to amend or extend a non-PIP Emerging Technologies Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. ⁽¹²⁾	9	50,426
B932	194 (new)	Amendment; application to amend a non-PIP Emerging Technologies registration. ⁽⁴⁾ ⁽⁵⁾ ⁽¹²⁾	6	20,172

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'New PIP' means a PIP with an active ingredient that has not been registered.

³'Registered PIP' means 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.

⁵If, during review of the application, it is determined that review by the FIFRA Scientific Advisory Panel (SAP) is needed, the applicant will submit an application for category B905, which will be processed concurrently, and the decision review time for both applications will be the longer of the two associated applications. The 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 Insect Resistance Management (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.

¹¹(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 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 section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (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.

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.

¹³This category does not include genetic modifications in animals not intended for use as a pesticide, e.g., genetic modifications in animals intended for food use or animals intended for use as companion animals.

¹⁴If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

PRIA Fee Category Table - Biopesticides Division (BPPD) - Plant-Incorporated Protectants (PIP)

Table 17.

PRIA Fees