Jump to main content.


Registration Service Fees
Preliminary Interpretations of Fee Categories for Applications Received by EPA from March 23, 2007 to September 30, 2007- Biopesticides and Polllution Prevention 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.

Microbial pesticides consist of a microorganism (e.g., a bacterium, fungus, virus or protozoan) as the active ingredient. Microbial pesticides can control many different kinds of pests, although each separate active ingredient is relatively specific for its target pest[s]. For example, there are fungi that control certain weeds, and other fungi that kill specific insects.

Biochemical pesticides are naturally occurring substances that control pests by non-toxic mechanisms. Conventional pesticides, by contrast, are generally synthetic materials that directly kill or inactivate the pest. Biochemical pesticides include substances, such as Straight Chain Lepidopteran Pheromones (SCLP). SCLPs are naturally occurring, or if synthesized, similar in structure (and functionally identical) to naturally occurring pheromones produced by lepidopteran species (moths and butterflies) that are chemically characterized by an unbranched, aliphatic chain, between 9 and 18 carbons in length, containing up to three double bonds in the aliphatic backbone, and ending in an alcohol, aldehyde, or acetate functional group. These compounds are exempt from the requirement of a tolerance when applied to growing crops at a rate up to 150 grams of active ingredient per acre per year. The toxicity of these types of chemicals is well-known and toxicity data is normally waived.

Plant-Incorporated Protectant is a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof. A peer review by the FIFRA Science Advisory Panel (SAP) may or may not be required for a given action.


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

Biopesticides and Pollution Prevention Division Fee Categories
DRAFT 3/20/04
EPA No. CR No. Action Interpretation
B58 03 New AI, Food Use, Microbial/Biochemical, w/Tolerance A new microbial or biochemical pesticide active ingredient.. Use requires a tolerance under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). A tolerance is the maximum residue level permitted for a pesticide active ingredient in or on food or animal feed, in accordance with FFDCA.
B59 04 New AI, Food Use, Microbial/Biochemical, w/Tol. Exemption A new microbial or biochemical pesticide active ingredient. Use requires an exemption from the requirement of a tolerance, which is appropriate when exposures to residues of the active ingredient causes no risks to the public health
B60 05 New AI, Non-Food Use, Microbial/Biochemical A new microbial or biochemical pesticide active ingredient. No food/animal feed uses.
B61 06 EUP, Food Use, Microbial/Biochemical, w/Temporary Tol./Exemption An experimental use permit for a microbial or biochemical pesticide. A temporary tolerance or exemption is set for an appropriate period of time to allow the harvested commodity to enter the food or feed supply.
B62 07 EUP, Non-Food Use, Microbial/Biochemical An EUP, with no food or feed uses, or with an agreement to destroy, or use only for experimental purposes, any crops treated during the experimental program.
B63 08 New Use, First Food Use, Microbial/Biochemical, w/Tol. Exemption Application for Registration of a new food use for a microbial or biochemical pesticide. Use requires an exemption from the requirement of a tolerance for the active ingredient, or a change in an existing exemption from tolerance when new data is required to support that change and where there is reasonably expectation that residues of the a.i. will occur in human food or use on livestock or livestock feed.
B64 09 New Use, First Food Use, Microbial/Biochemical, w/Tol. Application for Registration of a new food use for a microbial or biochemical pesticide. Use requires a tolerance(s) or a change in an existing tolerance for the active ingredient when residues of the ai will occur in human food or animal feed, and there is a potential human risk for dietary exposures above the maximum residues allowed.
B65 10 New Use, Non-Food, Microbial/Biochemical Application for Registration of a new use for a microbial or biochemical pesticide that will not result in residues in food/animal feed.
B66 11 New Product, Me-Too, Fast Track, Microbial/Biochemical A new product that is identical or substantially similar to an existing product.

Identical products are identical to another registered product and bear identical use patterns. Products that are substantially similar contain the same active ingredients, in substantially the same proportion, same physical/chemical properties, and the inert ingredients must be substantially similar, as the claimed similar product This requires no formal review of data, only a CSF.

Me-too products may have fewer uses, but all of its uses must have been approved for the claimed similar product. Adding or changing the use patterns (other than removal of uses) excludes the product from treatment as a substantially similar product.
B67 12 New Product, Non-Fast Track, Microbial/Biochemical

A new product containing an already registered pesticide active ingredient that includes data (mammalian and/or non-target toxicity, product chemistry, product performance, etc.) to support the registration and does not require a change in the tolerance or tolerance exemption.
B68 13 Amendment, Non-Fast Track, Microbial/Biochemical An amendment to an existing registration, with data that requires science review.
  • Alternate Formulations that result in significant changes to the basic formulation for the product
  • CRP
  • Signal word changes/review of acute tox data
  • Additional sources of ai with chemistry data
  • Efficacy reviews
  • A different pattern of use that changes or increases exposure requiring science review, i.e., increase in dosage rate, different method of application.
B69 14 SCLP, New AI, Food Use or Non-Food Use New active ingredient SCLP which fits within the existing tolerance exemption for SCLPs..
B70 15 SCLP, EUP (New AI or New Use) Application for an experimental use permit where the SCLP fits within the existing tolerance exemption for SCLPs, or with an agreement to destroy, or use only for experimental purposes, any crops treated during the experimental program.
B71 16 SCLP, New Product, Me-Too, Fast Track New product for an existing SCLP active ingredient that is substantially similar to an exiting product and requires minimal data review.
B72 17 SCLP, New Product, Non-Fast Track New product for an existing SCLP active ingredient that includes data to support the application.
B73 18 SCLP, Amendment, Non-Fast Track Application to amend an exiting registration for a SCLP product which requires data to support the application.
B74 19 PIP, EUP, Non-Food/Feed or Crop Destruct, No SAP A PIP EUP without food or feed uses, or with an agreement to destroy, or use only for experimental purposes, any crops treated during the experimental program. For example, no SAP would be expected when the EUP is for another genetic construct of a protein already approved for use.
B75 20 PIP, EUP, Set Temp. Tol. or Exemption, No SAP An experimental use permit to allow a PIP to be used under controlled, field or actual use conditions so that data required to support a federal registration can be developed to evaluate its efficacy and potential for adverse effects on humans and the environment.

A temporary tolerance or exemption is set for an appropriate period of time to allow the harvest of any treated food or feed commodities during the experimental period.

For example, no SAP would be expected when the EUP is for another genetic construct of a protein already approved for use.
B76 21 PIP, EUP, New AI, Non-Food/Feed or Crop Destruct, SAP A PIP EUP without food or feed uses, or with an agreement to destroy, or use only for experimental purposes, any crops treated during the experimental program. The new PIP raises issues which require a SAP.
B77 22 PIP, EUP, Set Temp. Tol. Or Exemption, SAP An experimental use permit to allow a PIP to be used under controlled, field or actual use conditions so that data required to support a federal registration can be developed to evaluate its efficacy and potential for adverse effects on humans and the environment.

A temporary tolerance or exemption is set for an appropriate period of time to allow the harvest of any treated food or feed commodities during the experimental period.

The new PIP raises issues which require a SAP.
B78 23 PIP, Register New AI, Non-Food/Feed, No SAP New PIP active ingredient for a non-food/feed use. No issues identified that warrant a SAP.
B79 24 PIP, Register New AI, Non-Food/Feed, SAP New PIP active ingredient for a non-food/feed use with issue(s) identified that warrant a SAP.
B80 25 PIP, Register New AI, Temp. Tol./Exemption Exists, No SAP New PIP active ingredient for a food/feed use. Tolerance or exemption from Tolerance already exists. No issues identified that warrant a SAP.
B81 26 PIP, Register New AI, Temp. Tol./Exemption Exists, SAP New PIP active ingredient for a food/feed use. Tolerance or exemption from Tolerance already exists. Issue(s) identified that warrant a SAP.
B82 27 PIP, Register New AI, Set Tol./Exemption, No SAP New PIP active ingredient for a food/feed use. Tolerance or exemption from Tolerance must be established. No issues identified that warrant a SAP.
B83 28 PIP, Register New AI, with EUP Request, Set Tol./Exemption, No SAP New PIP active ingredient for a food/feed use and EUP application accompanies the new ai application. Tolerance or exemption from Tolerance must be established. No issues identified that warrant a SAP.
B84 29 PIP, Register New AI, Set Tol./Exemption, SAP New PIP active ingredient for a food/feed use. Tolerance or exemption from Tolerance must be established. Issue(s) identified that warrant a SAP.
B85 30 PIP, Register New AI, w/EUP Request, Set Tol./Exemption, SAP New PIP active ingredient for a food/feed use and EUP application accompanies the new ai application. Tolerance or exemption from Tolerance must be established. Issue(s) identified that warrant a SAP.
B86 31 PIP, EUP, Amendment, Food Use Amendment to expand, extend, or modify an existing PIP EUP.
B87 32 PIP, New Use New use site amendment for an existing PIP product.
B88 33 PIP, New Product New product for an existing PIP active ingredient.
B89 34 PIP, Amendment, Seed Production to Commercial Registration Amending an existing PIP product with a registration to allow for growing seed, but not commercial sale and distribution to allow to commercial sale and distribution. Additional data for scientific review is typically considered that has not been part of the decision for the seed production registration.
B90 35 PIP, Amendment, Non-Fast Track Amendment to existing PIP product.

Publications | Glossary | A-Z Index | Jobs


Local Navigation


Jump to main content.