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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- Antimicrobials 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)

Antimicrobials Division Fee Categories     DRAFT 3/20/04
EPA No. CR No. Action Interpretation
A38 36 New Active Ingredient
Food use, with exemption
Use requires a tolerance exemption under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) or a food additive regulation or other clearance under section 409 of the FFDCA. An exemption from the requirement of a tolerance is appropriate when the total quantity of the chemical involves no hazard to the public health.
  • Pre- and post-harvest use on crops
  • Animal drinking water treatment (meat, meat by-products and/or milk tolerance exemption)
  • Process water treatment for post harvest use (field washing of raw agricultural commodities)
  • Treatment of permanent or semi-permanent food contact surfaces (sanitizers)
  • Use of the product in food contact articles, other than food packaging with an intended ongoing effect in the finished article, including the articles surface or in food that may contact the article (e.g., conveyor belt - claims to kill bacteria on articles that come in contact with belt)
  • Home produce washes
  • Treatment of raw agricultural commodities in a food processing facility (FDA food additive regulation) (e.g., washing, coloring, removal of stems, leaves or husks, shelling of nuts)
  • Process water treatment in a food handling facility to control a pest in the water (FDA food additive regulation)
  • Production of food packaging (FDA food additive regulation) (e.g., adhesives, coatings)
  • Production of food contact articles other than food packaging (FDA food additive regulation) (cutting board that contains an antimicrobial as a preservative)
  • Slimicides (FDA food additive regulation) (e.g., pulp and paper board)
A39 37 New Active Ingredient
Food use, with tolerance
Requires a 408 tolerance . A tolerance is the amount of residue allowed to remain in or on a raw agricultural commodity (RAC), food, or feed.
  • Pre- and post-harvest use on crops
  • Animal drinking water treatment (meat, meat by-products, and/or milk tolerance)
  • Process water treatment for post harvest use (field washing of raw agricultural commodities)
  • Treatment of permanent or semi-permanent food contact surfaces (sanitizers)
  • Use in the production of food contact articles, other than food packaging, with an intended ongoing effect in the finished article, including the article's surface or in food that may contact the article (e.g., conveyer belt: claims to kill bacteria on articles that come in contact with belt)
A40 38 New Active Ingredient
Non-food use, outdoor, FIFRA 2(mm) uses
  • Once through cooling tower
  • Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems, intermittently flooded areas)
  • Oil fields (marine use)
A41 39 New Active Ingredient
Non-food use, outdoor, other uses (not FIFRA 2(mm)
  • Wood preservative
  • Antifoulant
A42 40 New Active Ingredient
Non-food use, indoor, FIFRA 2(mm) uses
  • Residential use (i.e., carpet sanitizer, hard surface disinfectant )
  • Commercial, institutional, industrial premise and equipment (e.g., offices, hotels industrial buildings, nursing homes)
  • Agricultural premise treatment (e.g., farm structures, buildings and equipment, animal drinking water)
  • Materials Preservatives (e.g., adhesives, coatings, plastic, fabric)
  • Swimming pool, spa
  • Human drinking water systems (e.g., water purifier units, emergency water systems)
  • Industrial processes and water systems treatment (e.g., reverse osmosis water systems, sewage systems, recirculating cooling tower systems, oil field recovery (non-marine), evaporative condensers)
  • Medical premises and equipment (e.g., dental equipment, dental unit water lines, hospitals)
  • Food handling storage establishments premises and equipment (e.g., eating establishments, meat processing equipment, food handling equipment)
A43 41 New Active Ingredient
Non-food use, indoor, other uses
Wood preservative (pressure and non-pressure treatments. e.g., joinery and mill work for door, window frames)
A44 42 New Use
First food use, with exemption
First time an old chemical is used in a manner which may result in pesticide residues in or food, directly or indirectly. Tolerance exemption requested. This includes indirect food additive regulations or other clearances (409 FFDCA) established by FDA.
  • Pre- and post-harvest use on crops
  • Animal drinking water treatment (meat, meat by-products and/or milk tolerance exemption)
  • Process water treatment for post harvest use (field washing of raw agricultural commodities)
  • Treatment of permanent or semi-permanent food contact surfaces (sanitizers)
  • Use of the product in food contact articles, other than food packaging with an intended ongoing effect in the finished article, including the articles surface or in food that may contact the article (e.g., conveyor belt - claims to kill bacteria on articles that come in contact with belt)
  • Home produce washes
  • Treatment of raw agricultural commodities in a food processing facility (FDA food additive regulation) (e.g., washing, coloring, removal of stems, leaves or husks, shelling of nuts)
  • Process water treatment in a food handling facility to control a pest in the water (FDA food additive regulation)
  • Production of food packaging (FDA food additive regulation) (e.g., adhesives, coatings)
  • Production of food contact articles other than food packaging (FDA food additive regulation) (cutting board that contains an antimicrobial as a preservative)
  • Slimicides (FDA food additive regulation) (e.g., pulp and paper board)
A45 43 New use
First food use, with tolerance
First time an old chemical is used in a manner which may result in pesticide residues in or on food, directly or indirectly where a numerical tolerance is required.
  • Pre- and post-harvest use on crops
  • Animal drinking water treatment
  • Process water treatment for post harvest use (field washing of raw agricultural commodities)
  • Treatment of permanent or semi-permanent food contact surfaces (sanitizers)
  • Use in the product of food contact articles, other than food packaging with an intended ongoing effect in the finished article, including the articles surface or in food that may contact the article (e.g., conveyor belt: claims to kill bacteria on articles that come in contact with belt)
A46 44 New food use, with exemption Additional use to an old chemical resulting in pesticide residues in or on food, directly or indirectly. Tolerance exemption requested. This includes additional indirect food additive regulations or other clearances (409 FFDCA) established by FDA.
  • Pre- and post-harvest use on crops
  • Animal drinking water treatment (meat, meat by-products and/or milk tolerance exemption)
  • Process water treatment for post harvest use (field washing of raw agricultural commodities)
  • Treatment of permanent or semi-permanent food contact surfaces (sanitizers)
  • Use in the product of food contact articles, other than food packaging with an intended ongoing effect in the finished article, including the articles surface or in food that may contact the article (conveyor belt - claims to kill bacteria that on articles that come in contact with belt)
  • Home produce washes .
  • Treatment of raw agricultural commodities in a food processing facility (FDA food additive regulation) (e.g., washing, coloring, removal of leaves, stems or husks, shelling of nuts)
  • Process water treatment in a food handling facility to control a pest in the water (FDA food additive regulation-EPA dietary risk assessment)
  • Production of food packaging (FDA food additive regulation) (adhesives, coatings)
  • Production of food contact articles other than food packaging (FDA food additive regulation) (cutting board that contains an antimicrobial as a preservative)
  • Slimicides (i.e. pulp and paper board)
A47 45 New food use, with tolerance Additional use to an old chemical resulting in pesticide residues in or on food, directly or indirectly where a numerical tolerance is required.
  • Pre and post harvest use on crops
  • Animal drinking water treatment
  • Process water treatment for post harvest use (field washing of raw agricultural commodities)
  • Treatment of permanent or semi-permanent food contact surfaces (sanitizers)
  • Use in the product of food contact articles, other than food packaging with an intended ongoing effect in the finished article, including the articles surface or in food that may contact the article)
A48 46 New use
Non-food, outdoor FIFRA sec 2(mm) uses
  • Once through cooling tower
  • Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems, intermittently flooded areas)
  • Oil fields (marine use)
A49 47 New use, non-food, outdoor, other uses (not FIFRA 2(mm) uses
  • Wood preservative
  • Antifoulant
A50 48 New use, non-food, indoor FIFRA sec 2(mm) uses Residential use (i.e., carpet sanitizer, hard surface disinfectant)
  • Commercial, institutional, industrial premise and equipment (e.g., offices, hotels industrial buildings, nursing homes)
  • Agricultural premise treatment (e.g., farm structures, buildings and equipment, animal drinking water)
  • Materials Preservatives (e.g., adhesives, coatings, plastic, fabric)
  • Swimming pool, spa
  • Human drinking water systems (e.g., water purifier units, emergency water systems)
  • Industrial processes and water systems treatment (e.g., reverse osmosis water systems, sewage systems, recirculating cooling tower systems, oil field recovery (non-marine), evaporative condensers)
  • Medical premises and equipment (e.g., dental equipment, dental unit water lines, hospitals)
  • Food handling storage establishments premises and equipment (e.g., eating establishments, meat processing equipment, food handling equipment)
A51 49 New use, non-food, indoor, other uses Wood preservative, pressure and non-pressure treatments (e.g., joinery and mill work for door, window frames).
A52 50 Experimental Use Permit An experimental use permit is a tool that allows a pesticide to be used under controlled, field or actual use conditions so that data required to support a FIFRA section 3 registration can be developed necessary to evaluate efficacy and potential for safe use or adverse effects on humans and the environment (e.g., swimming pool use).
A53 51 New Product, me-too, fast track Identical or substantially similar in composition and use to an already registered product. Requires review of product chemistry data only.

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 product bears the same use patterns or fewer but adding or changing use patterns excludes the product from treatment as a substantially similar product. Substantially similar use patterns for public health products are limited to identical organisms on both products. For non-public health products, substantially similar use patterns could involve organisms that are similar but not identical.

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

A54 52 New product, non-fast track, FIFRA sec. 2(mm) uses New product, old chemical. Requires science review other than chemistry, including acute toxicity, efficacy, or a different pattern of use that changes or increases exposure such as a dosage rate increase or different method of application.
A55 53 New product, non-fast track, other uses New product, old chemical. Requires science review other than chemistry, including acute toxicity, efficacy, or a different use pattern that changes or increases exposure, such as a dosage rate increase or different method of application. This relates to non-FQPA uses: wood preservation, antifoulants, and food contact sanitizers.
A56 54 New manufacturing use product, old AI, selective citation A registration for a new manufacturing use product for an old chemical. Data requirements are fulfilled by submission of data and/or citation of selected studies required to support the proposed uses.
A57 55 Amendment, non-fast track An amendment with or without data that requires a toxicology, efficacy or other science review.
  • CRP exemptions
  • Signal word changes/review of acute tox data
  • New ai sources with chemistry data
  • Efficacy reviews
  • A modification to the pattern of use that changes or increases exposure requiring science review, e.g., increase in dosage rate, different method of application (fog vs spray, continuous mist), change in a use site, indoor product adding outdoor uses.

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