Pesticide Registration Improvement Extension Act (PRIA 3)
Fee Determination Decision Tree
Decision Tree Resources:
Active Ingredient - The active ingredient in a pesticide product is the component which kills/controls the target pest. The active ingredient or AI includes any substance, or group of substances as specified by the Agency, that prevents, mitigates, destroys, or repels any pest; or that acts as a plant growth regulator, desiccant, defoliant, or nitrogen stabilizer. Pesticides are generally regulated on the basis of the AI.
Acute Toxicity - The potential for a substance to result in adverse effects to an organism soon after exposure. The acute toxicity of a compound is established through scientifically verifiable data from animal studies or human exposure tests.
Additional use - A request to add another use or new use on the label for an active ingredient with currently EPA registered products. New uses mean:
- any proposed use pattern that would require the establishment of, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 of the Federal Food, Drug and Cosmetic Act;
- any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or
- 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.
Antimicrobial Pesticide - An antimicrobial pesticide is intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and in the intended use is exempt from, or otherwise not subject to, a tolerance or a food additive regulation. Wood preservatives and anti-foulants are classified as antimicrobial pesticides if the products have antimicrobial claims. Other wood preservative, anti-foulant, agricultural fungicide, and aquatic herbicide products are either classified as conventionals or biopesticides.
Biochemical Pesticides - Biochemical Pesticides are substances that: (1) are naturally occurring chemicals or are synthetically derived equivalents; (2) have a history of exposure to humans and the environment demonstrating minimal toxicity, or in the case of a synthetically-derived biochemical pesticides, are equivalent to a naturally occurring chemical that have such a history; and (3) have a nontoxic mode of action to the target pest(s).
Biochemical pesticides include, but are not limited to: (1) semiochemicals (insect pheromones and kairomones), (2) natural plant and insect regulators, (3) naturally occurring repellents and attractants, and (4) enzymes. Biochemical pesticides include substances, such as insect sex pheromones, which interfere with mating, as well as various scented plant extracts that attract insect pests to traps. Because it is sometimes difficult to determine whether a substance meets the criteria for classification as a biochemical pesticide, EPA has established the Biochemical Classification Committee to make such decisions.
Biopesticides - Biopesticides are certain types of pesticides derived from such natural materials as animals, plants, bacteria, and certain minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. At the end of 2001, there were approximately 195 registered biopesticide active ingredients and 780 products. Biopesticides fall into three major classes:
- 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.
The most widely used microbial pesticides are subspecies and strains of Bacillus thuringiensis, or Bt. Each strain of this bacterium produces a different mix of proteins, and specifically kills one or a few related species of insect larvae. While some Bt's control moth larvae found on plants, other Bt's are specific for larvae of flies and mosquitoes. The target insect species are determined by whether the particular Bt produces a protein that can bind to a larval gut receptor, thereby causing the insect larvae to starve
- Plant-Incorporated-Protectants (PIPs) are pesticidal substances that plants produce from genetic material that has been added to the plant. For example, scientists can take the gene for the Bt pesticidal protein, and introduce the gene into the plant's own genetic material. Then the plant, instead of the Bt bacterium, manufactures the substance that destroys the pest. The protein and its genetic material, but not the plant itself, are regulated by EPA.
- 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 insect sex pheromones, that interfere with mating, as well as various scented plant extracts that attract insect pests to traps. Because it is sometimes difficult to determine whether a substance meets the criteria for classification as a biochemical pesticide, EPA has established a special committee to make such decisions.
Child-Resistant Packaging (CRP) - Packaging designed to be significantly difficult for young children to open. Pesticide products that are required to be in child-resistant packaging must be certified, under 40 CFR section 157.34.
Chronic Toxicity - The potential for a substance to result in adverse effects to an organism after long-term exposure. The chronic toxicity of a compound is established through scientifically verifiable data from animal studies or human exposure tests.
Conventional Pesticide - Conventional pesticides are all active ingredients other than biological pesticides and antimicrobial pesticides. Conventional active ingredients are generally produced synthetically, i.e., are synthetic chemicals that prevent, mitigate, destroy, or repel any pest; or that act as a plant growth regulator, desiccant, defoliant or nitrogen stabilizer. Wood preservative and anti-foulant products that do not have antimicrobial uses and agricultural fungicide and aquatic herbicide products are either classified as a conventional or a biochemical pesticide. Biochemical pesticides with a toxic mode of action are classified for the purposes of the registration process as conventional pesticides.
Differ only in ways - The Agency has interpreted the phrase “….or that differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment….” with regard to a substantially similar or identical product to mean:
- the proposed product must contain the same active ingredient,
- have the same percentage or fall within the range of composition of currently registered products,
- have the same chemical composition,
- have similar inert ingredients and contain the same use patterns or fewer.
Efficacy Data - Data showing that the pesticide is effective in controlling the pests for which control claims are made on the product label. Efficacy data are routinely required to be submitted to support products that control pests of public health significance, including but not limited to products to control pathogenic bacteria, viruses, mosquitoes, ticks, roaches, fleas, rats, and mice. Efficacy data requirements related to these types of pest control products are detailed at 40 CFR §158.640. Also, refer to the OPPTS Harmonized Test Guidelines, Series 810 and Antimicrobial Science Policies, Disinfectant Technical Science Section (DIS/TSS) documents.
Although efficacy data (product performance data) are not routinely required to be submitted for most insecticide, fungicide, or herbicide products, the applicant or registrant must conduct efficacy tests on each of its products in order to ascertain through testing that the product performs in accordance with its labeling and use directions claims.
- Efficacy data may be required to be submitted on a case-by-case basis and must be kept in the applicant's or registrant's files.
End-Use Product (EP) - An EP is a pesticide product whose labeling (1) includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, and (2) does not state that the product may be used to manufacture or formulate other pesticide products. 40 CFR § 153(b).
Experimental Use Permits (EUPs) - An EUP is a permit authorized under FIFRA section 5 that allows applicants to develop data to support an anticipated registration application. 40 CFR Part 172 provides more detail on which data collection activities may require an EUPs.
FIFRA Science Advisory Panel (SAP) - The FIFRA SAP, authorized under FIFRA, is an independent review panel. Its charge is to comment on actions under section 6 and 25(a), and to comment on and make recommendations on scientific analyses done by the Agency.
Fast track amendments - If an amendment requests a change to a product that is "substantially similar" or "identical" to another product or "differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment" from another product, the similar or identical product and its applicable data may be cited in lieu of submitting required product-specific data. This amendment includes labeling changes or basic alternate product formulation changes that do not require supporting data and is also called a "me-too" amendment.
Food Use - A food use is a use in, on or around or that may come into contact with food, including water for human consumption; feed, including water for animal consumption; or livestock unless a review of all available data supports the conclusion that the use will not result in residues in the food (including water for human consumption) or feed (including water for animal consumption).
Examples of Food Uses:
- Pre- and post-harvest use on crops
- Direct or indirect application to livestock
- Crop seed treatments
- Human and animal drinking water treatment ((e.g., water purifier units, emergency water systems, municipal water treatment)
- Home produce washes
- Home gardens
- 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
- Structure treatments, where the structure is used to support livestock? (includes feeding or drinking water troughs)
- Livestock feed-throughs
- Process water treatment in a food handling facility to control a pest in the water
- Production of food packaging
- Production of food contact articles other than food packaging (cutting board that contains an antimicrobial as a preservative)
- Food handling storage establishment premises and equipment (e.g. eating establishments, meat processing equipment, food handling equipment)
- Aseptic packaging
- Ethanol production (treatment of empty fermentation tank)
- Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems)
Inert Ingredients - FIFRA 2(m) defines inert ingredient as "an ingredient which is not active." Inert ingredients may be solvents, carriers, perfumes, dyes, perfumes, and surfactants. They include any substance (or group of structurally similar substances) other than the active ingredient(s) that are intentionally included in a pesticide product. Inert ingredients are regulated under both FIFRA and FFDCA.
Interregional Research Project No. 4 (IR-4) - Funded by the U.S. Department of Agriculture; IR-4 generates data to support minor use registrations, and coordinates the development of information on the clearance of these pesticides.
Manufacturing Use Product (MP or MUP) - An MP or MUP is any pesticide product other than an end use product. A product may consist of the technical grade of active ingredient only, or may contain inert ingredients such as stabilizers or solvents (40 CFR § 153(h)). MPs are intended and labeled for formulation and repackaging into other pesticide products.
Me-Too Product - A "Me-Too" pesticide registration application refers to a request to register a new pesticide product that is identical in its uses and formulation or substantially similar in its uses and formulation to one or more products currently registered and marketed in the United States, or differing only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment. These applications are also called "Fast Track New Products," though the preferred term consistent with FIFRA is "identical or substantially similar product." For all "me-toos," the Agency must also find that approving the registration or amendment in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment.Common terms used for some "Me-Toos" are:
- Identical Repack Registrations
A complete (100-percent) repackaging of an identical, already registered product, where the same label is used for the product other than name , address, name of product, and registration number.
- Old Chemical New Product Registrations
A previously registered active ingredient that is being reformulated to make a new product with the same use pattern as the registered active ingredient. (Note: the applicant will be required to explain how the labeling has been derived and justify certain aspects of the labeling.)
- the maximum use rate of the product is increased beyond that which is currently registered;
- a pre-harvest interval (PHI) is changed;
- any other changes are made that might affect the pesticide residues in food or feed commodities or exposure to nontarget organisms;
- the source of the active ingredient is not registered;
- inert ingredients do not currently exist in any other pesticide formulation;
- a reference is made to a cancelled product (link to NPIRS );
- significant changes in the percentage of active ingredient;
- new formulation types;
- differences in directions for controlling new, non-public health pests;
- differences in directions for new dosage rates;
- differences in directions for different frequency and timing of applications;
- differences in directions for use in geographical locations other than those previously registered; and
- differences in directions for use on new sites and for new methods of application for that active ingredient or ingredients.
- Applicant submits required acute toxicity and efficacy data for EPA review.
- Applicant references similar, registered pesticide product and submits product chemistry and required efficacy for specific formulation purposes.
- Applicant asserts similarity, but does not reference a registered pesticide product. Submits product chemistry.
- Applicant references a similar pesticide product and submits product chemistry and required nitrosamine data for a specific formulation.
- Applicant does not reference a pesticide product. Submits product chemistry and required nitrosamine data for a specific formulation.
- Applicant does not reference a pesticide product. Submits product chemistry and the full battery of acute data.
- Applicant references a similar registered pesticide product. Submits product chemistry, the full battery of acute data and required efficacy data.
- Applicant references a pending registration.
Microbial Pesticides - Microorganisms that produce a pesticidal effect that are: (1) eukaryotic microorganisms including, but not limited to, protozoa, algae, and fungi; (2) prokaryotic microorganisms, including, but not limited to, bacteria; or (3) autonomous replicating microscopic elements, including, but not limited to, viruses.
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. The most widely used microbial pesticides are subspecies and strains of Bacillus thuringiensis, or Bt. Each strain of this bacterium produces a different mix of proteins and specifically kills one or a few related species of insect larvae. While some Bt's control moth larvae found on plants, other Bt's are specific for larvae of flies and mosquitoes. The target insect species are determined by whether the particular Bt produces a protein that can bind to a larval gut receptor, thereby causing the insect larvae to starve.
Minor Use - "The use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health"(FIFRA section 2(ll)) under certain conditions. These conditions include where the total U.S. acreage for the crop is less than 300,000 acres; or the use does not provide sufficient economic incentive to support the initial or continuing registration of the pesticide for the use, provided additional criteria are met, such as that the pesticide plays a significant part in managing pest resistance or in an integrated pest management program.
New Active Ingredient - An active ingredient that is not currently contained as an active ingredient in any EPA registered pesticide product.
New Use - A new use, when used with respect to a product containing a particular active ingredient, means:
- Any proposed use pattern that would require the establishment of, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 of the Federal Food, Drug, and Cosmetic Act;
- Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or
- 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.
Nontarget Organism - Any organism for which pesticidal control was either not intended or not legally permitted by application of a pesticide.
Plant-Incorporated-Protectants (PIPs) - Pesticidal substances and the genetic material needed to produce them by plants that have been genetically modified so the plant is protected from certain insect pests. For example, scientists can take the gene for the Bt pesticidal protein from the bacterium, and introduce that gene into the plant's own genetic material. Then the plant manufactures the substance that destroys the pest. EPA regulates the protein and its genetic material, but not the plant itself. It also includes any inert ingredient contained in the plant, or product thereof. A peer review by the FIFRA Science Advisory Panel (SAP) may or may not be required for a given action -- this is determined on a case-by-case basis.
Product Chemistry - Applies to data on a product's composition and the physical and chemical characteristics of the active ingredient and products. These data include:
- information on the starting materials, product, or formulating process;
- information on possible formation of impurities;
- results of preliminary analysis of product samples;
- description of analytical methods to identify and quantify ingredients and validation data for such methods; and
- information on stability, oxidizing and reducing action, flammability, explodability, storage stability, corrosion, dielectric breakdown voltage, octanol/water partition coefficient, vapor pressure, viscosity, and miscibility of the product.
Product Performance - Efficacy; A study to determine how efficacious a pesticide is towards its targeted pest(s).
Reduced Risk Pesticides - FIFRA section 3(c) (10) provides for expediting the review of certain types of applications for registration. This program is referred to as the Conventional Reduced Risk Pesticide Program (link to Conventional Reduced Risk Pesticide Program) . The Reduced Risk program expedites the review and regulatory decision-making process of conventional pesticides that meet one or more of the following criteria:
- Reduce the risks of pesticides to human health.
- Reduce the risks of pesticides to nontarget organisms.
- Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.
- Broaden the adoption of integrated pest management strategies, or make such strategies more effective.
This program does not apply to biological or antimicrobial pesticides, which are handled through separate expediting processes.
Science Advisory Panel (SAP) - The FIFRA SAP, authorized under FIFRA, is an independent review panel. Its charge is to comment on actions under section 6 and 25(a), and to comment on and make recommendations on scientific analyses done by the Agency. FIFRA Science Advisory Panel Web site.
Small Business - A small business means a corporation, partnership, or un-incorporated business that has 500 or fewer employees and, during the 3-year period before the most recent maintenance fee billing cycle, has average annual global gross revenue from pesticides that did not exceed $60 million (including any such revenue from all of its affiliates).
Straight Chain Lepidopteran Pheromone (SCLP) - SCLPs are naturally occurring, or if synthesized, structurally and functionally identical to naturally occurring pheromones produced by moths and butterflies that are chemically characterized by a long, straight chain of fatty acids, between 9 and 18 carbons in length, containing up to three double bonds 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 (extremely low) toxicity of these types of chemicals is well-known and toxicity data is normally waived.
Tolerance - The maximum permissible residue level for pesticides in raw agricultural produce and processed foods. Any food bearing a pesticide residue for which there is no tolerance or exemption from tolerance in effect is considered adulterated and subject to seizure. Similarly, if a pesticide residue in a food exceeds the applicable tolerance, the food would be considered adulterated and subject to seizure. EPA establishes the tolerances, which are enforced by the Food and Drug Administration and the Department of Agriculture. Before the passage of the Food Quality Protection Act of 1996, established tolerances and exemptions for pesticide chemicals in or on RACs were established in section 408 of FFDCA and tolerances, where needed for processed commodities, were set in section 409. Under FQPA, all tolerances or exemptions will be set under section 408. EPA will not register a pesticide under FIFRA until all needed tolerances have been established.
"50% Waiver - An applicant that meets the definition of a small business is eligible for a fifty percent (50%) waiver of the pesticide registration service fee. A small business means a corporation, partnership, or un-incorporated business that has 500 or fewer employees and during the 3-year period prior to the most recent maintenance fee billing cycle beginning January 15, has an average annual global gross revenue from pesticides that did not exceed $60 million (including any such revenue from all of its affiliates).
75% Waiver - An applicant that meets the definition of a small business, a corporation, partnership or un-incorporated business of 500 employees or fewer and during the 3-year period prior to the most recent maintenance fee billing cycle beginning January 15, has an average annual global gross revenue from pesticides of less than $10 million (including any such revenue from all of its affiliates) is eligible for a seventy-five percent (75%) waiver of the pesticide registration service fee.