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Registration Service Fees
Preliminary Interpretations of Fee Categories for Applications Received by EPA from March 23, 2007 to September 30, 2007 - Registration Division

Current as of October 2007

Resources

Fee Categories:

The 90 Fee Categories Have Been Separated into Three (3) Tables for the Regulatory Divisions. The Tables Provide a Crosswalk of the Fee Code Numbers Listed in the Congressional Record and the Federal Register (Published on March 17, 2004).

The Three Tables Attached Below, Do Not Read Identically Because There Are Circumstances Which Do Not Allow This, Based on the Types of Applications Processed in Each Division (E.g. Antimicrobials, Biopesticides and Conventional Pesticides). However, All Three Divisions Agree and Define or Interpret the Following Types of Applications Identically Thus They Are Not Reiterated in Applicable Fee Code Categories.

New Active Ingredient

New Use (As Defined in 40 Cfr 152.3)

    1. Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 or 409 of the Federal Food, Drug and Cosmetic Act;
    2. Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or
    3. Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms.

Experimental Use Permit as Define in 40 Cfr 172.2

    1. a pesticide not registered with this Agency or
    2. a registered pesticide for a use not previously approved in the registration of the pesticide may apply to the Administrator at any time for an experimental use permit. (b) Pesticides under experimental use permits may not be sold or distributed other than through participants and, if sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of the experimental use permit.

Printed version (PDF) : Federal Register: March 17, 2004
(172 KB, 10 pgs PDF)

Registration Division Fee Categories     DRAFT 3/20/04
EPA No. (1) CR No. (2) Action Interpretation
R1 56 Food use An application that proposes a new food use that would require the establishment of, the increase in or the exeption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA. The submission will contain e.g. a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s). If the applicants for the manufacturing use product and end-use product are not with the same company, each application will be reviewed as a separate application under this category and the fee will apply to both applicants.
R2 57 Food use, reduced risk An application that proposes a new food use that would require the establishment of, the increase in or the exeption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA. The submission will contain e.g. a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s). The submission will contain e.g. a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s). If the applicants for the manufacturing use product and end-use product are not with the same company, each application will be reviewed as a separate application under this category and the fee will apply to both applicants A "reduced risk" submission must accompany the application for registration. The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstate that the use/applicaton is reduced risk, the Agency may reject reduced risk status..
R3 58 Food use; Experimental Use Permit request submitted simultaneously with application for registration An Experimental Use Permit (EUP) application and the first application for registration submitted simultaneously for food use(s) of an active ingredient that is currently not contained as an active ingredient in any registered pesticide product and where there is reasonable expectation that residues of the pesticide will occur in food or feed. The submission also contains e.g. a petition for temporary tolerances or exemption(s) from tolerances for all food/feed commodities covered by the pending registration application (s); or a certification that all food/feed treated under the EUP will be destroyed or fed to experimental animals for testing purposes only; an EUP request; and an application for registration of a pesticide product
R4 59 Food use; Experimental Use Permit with temporary tolerance, submitted before application for registration An Experimental Use Permit (EUP) application for food use(s) of an active ingredient that is currently not contained as an active ingredient in any registered pesticide product and where there is reasonable expectation that residues of the pesticide will occur in food or feed. The submission also contains e.g. a petition for temporary tolerances or exemption(s) from tolerances for all food/feed commodities covered by the pending registration application(s). ; or a certification that all food/feed treated under the EUP will be destroyed or fed to experimental animals for testing purposes only.
R5 60 Food use; submitted after an Experimental Use Permit An application that proposes a new food use that would require the establishment of, the increase in or the exeption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA. The submission will contain e.g. a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s).. Data required to support the first application for registration has been previously reviewed in association with an earlier EUP for the same use(s).
R6 61 Non-food use, outdoor The first application for registration for an active ingredient that is currently not contained as an active ingredient in any registered pesticide product. The product is for use outside of manmade structures and there is reasonable expectation that residues of the pesticide will not occur in food or feed commodities. If the applicants for the manufacturing use product and end-use product are not the same, each application will be reviewed under this category and the fee will apply to both applicants. Also included in this category is any application for an old chemical in which the applicant wants the Agency to evaluate a data set that is comparable to the data set of a new active ingredient.
R7 62 Non-food use, outdoor, reduced risk The first application for registration for an active ingredient that is currently not contained as an active ingredient in any registered pesticide product. The product is for use outside of manmade structures and there is reasonable expectation that residues of the pesticide will not occur in food or feed commodities. A "reduced risk" submission must accompany the application for registration. The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstate that the use/applicaton is reduced risk, the Agency may reject reduced risk status
R8 63 Non-food use, outdoor Experimental Use Permit request submitted simultaneously with application for registration An Experimental Use Permit request and the first application for registration for the same active ingredient submitted simultaneously for non-food use(s) of an active ingredient that is currently not contained in any registered pesticide product. The product is for use outside of manmade structures and there is reasonable expectation that residues of the pesticide will not occur in food or feed commodities.
R9 64 Non-food use, outdoor Experimental Use Permit submitted before application for registration An Experimental Use Permit request for non-food use(s) of an active ingredient that is currently not contained in any registered pesticide product. The product is for use outside of manmade structures and there is reasonable expectation that residues of the pesticide will not occur in food or feed commodities
R10 65 Non-food use, outdoor, submitted after Experimental Use Permit The first application for registration for non-food use(s) of an active ingredient that is currently not contained in any registered pesticide product. Data required to support the first application for registration has been previously reviewed or is being reviewed in association with an earlier EUP for the same use(s).
R11 66 Non-food use, indoor The first application for registration for an active ingredient that is currently not contained in any registered pesticide product. The product is for use inside of manmade structures and there is reasonable expectation that residues of the pesticide will not occur in food or feed. If the applicants for the manufacturing use product and end-use product are not the same, each app0lication will be reviewed under this category and the fee will apply to both applicants. Also included in this category is any application for an old chemical in which the applicant wants the Agency to evaluate a data set that is comparable to the data set of a new active ingredient..
R12 67 Non-food use, indoor, reduced risk The first application for registration for an active ingredient that is currently not contained in any registered pesticide product. The product is for use inside of manmade structures and there reasonable expectation that residues of the pesticide will not occur in food or feed. a chemical is an initial assessment. A "reduced risk" submission must accompany the application for registration. The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstate that the use/applicaton is reduced risk, the Agency may reject reduced risk status
R13 68 First Food Use, Indoor, Food/Feed Handling An application that proposes the first food use that would require the establishment of, the increase in, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 or 409 of the FFDCA.. The submission will contain e.g. a petition to establish tolerances or exemption(s)a petition to establish tolerance(s) or an exemption from tolerances for all food/feed commodities in the pending application where there is reasonable expectation that residues of the pesticide will occur in food or feed. The product is for use inside of manmade structure in commercial or institution use areas where human food and animal feed are prepared and stored [excluding greenhouses] .
R14 69 Additional food use, Indoor, Food/Feed Handling An application for an additional food use that would require the establishment of , the increase in,or the exemption from the requirement of, a tolerance or food additive regulation under section 408 or 409 of the FFDCA. The submission will contain a petition to establish tolerances or an exemption from tolerances for all food/feed commodities in the pending application where there is reasonable expectation that residues of the pesticide will occur in human food or use on livestock or livestock feed. The product is for use inside a manmade structure in commercial or institution use in areas where human food and animal feed are prepared and stored [excluding greenhouses] .
R15 70 First Food Use An application that proposes the first food use that would require the establishment of, the increase in, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 or 409 of the FFDCA.. The submission will contain a petition to establish tolerances or an exemption(s) from tolerances for all food/feed commodities in the pending application where there is reasonable expectation that residues of the pesticide will occur in human food or use on livestock or livestock feed
R16 71 First Food Use, Reduced Risk An application that proposes the first food use that would require the establishment of, the increase in, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 or 409 of the FFDCA The submission will contain a petition for tolerances or an exemption from tolerances where there is reasonable expectation that residues of the pesticide will occur in human food or use on livestock or livestock feed. A "reduced risk" submission must accompany the application for registration. The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstate that the use/applicaton is reduced risk, the Agency may reject reduced risk status.
R17 72 Each Additional New Food Use An application that proposes an additional food use that would require the establishment of, the increase in or the exeption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA.. This submission also contains e.g. a petition for tolerance(s) for a specific crop or representative commodities for a specific crop subgroup or a specific crop group or an exemption from tolerances where there is reasonable expectation that residues of the pesticide will occur in human food or use on livestock or livestock feed
R18 73 Each Additional New Food Use, Reduced Risk An application that proposes an additional food use that would require the establishment of, the increase in or the exeption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA.. This submission also contains e.g. a petition for tolerances or an exemption from tolerances where there is reasonable expectation that residues of the pesticide will occur in human food or use on livestock or livestock feed on a new distinct application site or specific food crop. A "reduced risk" submission must accompany the application for registration. The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstate that the use/applicaton is reduced risk, the Agency may reject reduced risk status.
R19 74 Additional New Food Use, Bundled, 6 or more An application that proposes additonal food uses, 6 or more, that would require establishment of, the increase in, or the exemption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA. The submission also contains e.g.a petition for tolerances or an exemption from tolerances for at least (6) specific food or feed crops or 6 or more representative commodities for crop subgroups or crop groups where there is reasonable expectation that residues of the pesticide will occur in human food or use on livestock or livestock feed.A "reduced risk" submission must accompany the application for registration.
R20 75 Additional New Food Use, Bundled, 6 or more, Reduced Risk An application that proposes additonal food uses, 6 or more, that would require establishment of, the increase in, or the exemption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA The submission also contains a petition for tolerances or exemption from the requirement of tolerances for at least (6) specific food or feed crops or 6 or more representative commodities for crop subgroups or crop groups where there is reasonable expectation that residues of the pesticide will occur in human food or use on livestock or livestock feed.The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstate that the use/applicaton is reduced risk, the Agency may reject reduced risk status.
R21 76 New Food Use with Experimental Use Permit and temporary tolerance (no credit toward new use registration) An application for an Experimental Use Permit (EUP) for testing any registered pesticide for a use not currently registered on food, livestock or livestock feed . There is also e.g. a petition to establish temporary tolerances or an exemption from tolerances where there is reasonable expectation that residues of the active ingredient (ai) will occur in human food or use on livestock or livestock feed. The temporary tolerance or exemption from tolerance is issued for a period designated to allow the orderly marketing of the raw agricultural commodities produced while testing the pesticide chemical under the EUP. Fees will not cover any subsequent application for registration of the new use.
R22 77 New Food Use with Experimental Use Permit, Crop Destruct Basis An application for an Experimental Use Permit (EUP) for testing any registered pesticide for a use not currently registered on food or feed crops (including but not limited to crops subsequently grown on land which may reasonably be expected to contain pesticide residues). All crops affected by such testing must be destroyed (CROP DESTRUCT PERMIT).
R23 78 New Use, Non-food, Outdoor An Application for Registration of an additional use for an active ingredient not currently included in the directions for use of any registered product that contains such active ingredient (ai). Use of the product occurs outside manmade structures where there is no reasonable expectation from the use that residues of the pesticide will occur in human food.
R24 79 New Use, Non-food, Outdoor, Reduced Risk An Application for Registration of an additional use for an active ingredient not currently included in the directions for use of any product that contains such active ingredient (ai). Use of the product occurs outside manmade structures where there is no reasonable expectation from the use that residues of the pesticide will occur in human food. A "reduced risk" submission must accompany the application for registration, or the registrant must indicate in the transmittal letter that "reduced risk" status is being pursued and that the associated submission is forthcoming. The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision review times. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or incomplete, the Agency may re-evaluate and possibly revoke the submission's reduced risk status
R25 80 New Use, Non-food, Outdoor with Experimental Use Permit (no credit toward new use registration) An Experimental Use Permit (EUP) for testing any registered pesticide for an unregistered use where there is no reasonable expectation from the use that residues of the pesticide will occur in human food outside any manmade structure. Fees will not cover any subsequent application for registration of the new use.
R26 81 New Use, Non-food, Indoor An Application for Registration of an additional use for an active ingredient not currently included in the directions for use of any product that contains such active ingredient (ai) inside manmade structures where there is no reasonable expectation from the use that residues of the pesticide will occur in human food. Review of animal use products with existing tolerances or meat/milk tolerances fall under this category for review.
R27 82 New Use, Non-food, Indoor, Reduced Risk .An Application for Registration of an additional use for an active ingredient not currently included in the directions for use of any product that contains such active ingredient (ai) inside manmade structures where there is no reasonable expectation from the use that residues of the pesticide will occur in human food.feed.The Agency's Reduced Risk Committee will evaluate the submission and make the determination, based on criteria listed in PR Notice 97-3 and FIFRA 3(10) (B) (i-iv) , whether the requested use(s) qualify as "reduced risk" when compared to currently registered pesticides for the use(s). In the event that all uses do not qualify as reduced risk, the non-reduced risk uses will not get the reduced decision timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstate that the use/applicaton is reduced risk, the Agency may reject reduced risk status.
R28 83 Import tolerance
New active ingredient or first food use
Petition for food or feed tolerances for residues on food or feed commodities imported into the U.S.A. for an new active ingredient without a domestic registration or the first food use for an active ingredient for which no domestic registration exists for that use.
R29 84 Import tolerance
Additional new food use
Petition for food or feed tolerances for residues on additional food or feed commodities imported into the U.S.A. for an active ingredient for which no domestic registration exists for that use.
R30 85 New product - Me-Too, Fast Track An application for registration of an end-use pesticide product that is substantially similar or identical in its uses and/or formulation to products that are currently registered.. All applications require product chemistry data unless it is identical (e.g.100% repackaged product) and bridging/waiver rationale for each of the 6 acute toxicity studies. An application does not qualify for an expedited review if an unregistered source of TGAI material is used, efficacy and/or acute toxicity data are submitted with the application to support a change and/or additional end use product chemistry data beyond the Group A data are submitted to support the label or Confidential Statement of Formula.

Substantially similar: Product must have the same active ingredient, in substantially the same proportion, same chemical composition (solid, liquid, granular), and substantially similar inert ingredients as the already registered product,. In addition, substantially similar means that the proposed product bears the same use patterns but adding or changing use patterns excludes the proposed product from treatment as a substantially similar product..

Identical products: Same composition and use patterns as an already registered end use product.

R31 86 New product - Non-Fast Track, (includes reviews of product chemistry, acute toxicity, public health pest efficacy) An application for registration of a pesticide product that is not substantially similar or identical in it uses and/or formulation to products that are currently registered. These applications require product chemistry data (Group A and Group B), acute toxicity data (addressing all 6 endpoints), efficacy data and/or public health pest efficacy data, companion animal safety data, and/or child resistant packaging data where applicable.

An application for registration of a pesticide product that is substantially similar or identical in its uses and formulation to a product currently registered and an acute toxicity study(s) and or efficacy data are submitted for review fall under this category. An application for a product that is used as both an end-use and TGAI or MUP would fall under this category as long as the proposed uses on the product are similar or identical to another currently registered product for the same active ingredient. All applications using an unregistered source of TGAI material to formulate an end use product, applications to register a Manufacturing Use Product (MUP) or Technical Grade Active Ingredient (TGAI) and applications for termite baits, applications where the registrant is submitting acute toxicity data (addressing all 6 endpoints), efficacy data and/or public health pest efficacy data, companion animal safety data, and/or child resistant packaging data would fall under this category.

R32

87 New product - Non Fast Track, new physical form (excludes selective citations) An application for registration of a pesticide product that is not substantially similar or identical in its uses or formulation to products that are currently registered. A change in the formulation that would change the way a product is applied, change the tolerances currently established, change the toxicity of the product, pre-mix never registered, change in application rates, PHI, animal products with rate depletion data, etc. In all cases for these types of application tolerances currently exist.
R33 88 New manufacturing-use product, Old AI, Selective citation (MP or MUP) is any product intended (labeled) ONLY for formulation or repackaging into an end use formulated pesticide product. This product does not contain directions for use as normally found on an end use product. This product can ONLY be formulated for uses that are currently registered for the active ingredient. Submission of product chemistry data and acute toxicity data are required with this application. Data requirements are fulfilled by submission of data and/or citation of selected studies required to support the proposed uses.
R34 89 Non-fast track (includes changes to precautionary label statements, source changes to an unregistered source) Modification in the label, formula, or packaging of a registered product which is not substantially similar to a currently registered product and which requires the submission of data by registrant and analysis by the Registration Division (RD) only. Examples of actions in this category include: label changes to Precautionary Statements based on product chemistry and/or acute product toxicity data; efficacy data; companion animal safety data; child resistant packaging data; formula changes to use an unregistered source of active ingredient.
R35 90 Non-fast track (changes to REI, PPE, PHI, rate and number of applications, add aerial application, modify GW/SW advisory statement Modification in the label of a registered product which is not substantially similar to a currently registered product and which requires risk analysis by the Agency (i.e. by the Health Effects Division (HED), the Environmental Fate and Effects Division (EFED), the Biological and Economic Analysis Division (BEAD), et al) to support the change. Examples of actions in this category include: label changes to Directions for Use (including REI, PPE, PHI, application rate, application frequency, application timing, addition of aerial or chemigation application methods, ground water or surface water advisory statements, et al) that require risk analysis by EPA.
R36 91 Non-fast track, isomers Registration of a new product using an isomer of a registered active ingredient when there are currently no registered products for the isomer alone.
  • includes: new products where the active ingredient is a variation on the molecular structure or composition of a registered product and which will cite at least some of the generic data conducted with the registered product
R37 92 Cancer reassessment, applicant-initiated An application which requests to change the cancer classification made by the Agency on a specific chemical. This application is not being submitted due to a request from the Agency.

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