['Pesticides']
['Pesticide Registration and Labeling', 'Federal Insecticide, Fungicide and Rodenticide Act', 'Pesticides']
08/26/2024
Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.
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Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA regulates all pesticides that are sold and distributed in the United States. The term “pesticides” includes pesticides, herbicides, rodenticides, antimicrobial products, biopesticides, and other substances used to control a wide variety of pests. A pesticide product is defined as a pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold and includes any physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.
Before any pesticide product that EPA has not exempted from registration requirements can be lawfully sold or distributed, EPA performs a rigorous, comprehensive scientific assessment of the product, resulting in a registration decision. Under this review, the agency evaluates the following to ensure that, when the product is used according to labeled directions, no unreasonable adverse effects on human health or the environment will occur:
- The product’s active ingredient(s),
- Other constituent substances (including inert ingredients), and
- The proposed use pattern(s).
When EPA has determined that no unreasonable adverse effects to human health or the environment will result from the sale or distribution of a pesticide product, the agency grants the applicant a license or “registration” to legally sell and distribute the product in the United States. Once an EPA registration has been granted, applicants will then need to comply with the individual registration requirements imposed by the states in which they wish to market their product. The establishment in which a pesticide product is produced must also be registered.
Scope
Any person seeking to obtain a registration for a new pesticide product must submit an application for registration, containing the information specified in 40 CFR 152.50. An application for new registration must be approved by the EPA before the product may legally be distributed or sold, except as provided by 152.30.
Regulatory citations
- 40 CFR 150 to 180 — Pesticide programs
Key definitions
- Act or FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136-136y).
- Active ingredient: Any substance (or group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a), except as provided in 174.3 of this chapter.
- Acute dermal LD50: A statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test population under specified conditions.
- Acute inhalation LC50: A statistically derived estimate of the concentration of a substance that would cause 50 percent mortality to the test population under specified conditions.
- Acute oral LD50: A statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test population under specified conditions.
- Administrator: The Administrator of the United States Environmental Protection Agency or his delegate.
- Agency: The United States Environmental Protection Agency (EPA), unless otherwise specified.
- Applicant: A person who applies for a registration or amended registration under FIFRA sec. 3.
- Biological control agent: Any living organism applied to or introduced into the environment that is intended to function as a pesticide against another organism declared to be a pest by the Administrator.
- Distribute or sell, or distributed or sold, or distribution or sale: The acts of distributing, selling, offering for sale, holding for sale, shipping, holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any State.
- End use product: 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 the growth of plants, and (2) Does not state that the product may be used to manufacture or formulate other pesticide products.
- Final printed labeling: The label or labeling of the product when distributed or sold. Final printed labeling does not include the package of the product, unless the labeling is an integral part of the package.
- Inert ingredient: Any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product, except as provided by 174.3 of this chapter.
- Institutional use: Any application of a pesticide in or around any property or facility that functions to provide a service to the general public or to public or private organizations, including but not limited to: (1) Hospitals and nursing homes. (2) Schools other than preschools and day care facilities. (3) Museums and libraries. (4) Sports facilities. (5) Office buildings.
- Living plant: A plant, plant organ, or plant part that is alive, viable, or dormant. Examples of plant parts include, but are not limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.
- Manufacturing use product: Any pesticide product that is not an end-use product.
- New use: When used with respect to a product containing a particular active ingredient, means: (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 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.
- Operated by the same producer: When used with respect to two establishments, means that each such establishment is either owned by, or leased for operation by and under the control of, the same person. The term does not include establishments owned or operated by different persons, regardless of contractual agreement between such persons.
- Package or packaging: The immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.
- Pesticide: Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, other than any article that: (1) Is a new animal drug under FFDCA sec. 201(w), or (2) Is an animal drug that has been determined by regulation of the Secretary of Health and Human Services not to be a new animal drug, or (3) Is an animal feed under FFDCA sec. 201(x) that bears or contains any substances described by paragraph (s) (1) or (2) of this section.
- Pesticide product: A pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold. The term includes any physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.
- Plant-incorporated protectant: 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.
- Released for shipment: A product becomes released for shipment when the producer has packaged and labeled it in the manner in which it will be distributed or sold, or has stored it in an area where finished products are ordinarily held for shipment. Products stored in an area where finished products are ordinarily held for shipment, but which are not intended to be released for shipment must be physically separated and marked as not yet released for shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment unless subsequent activities, such as relabeling or repackaging, constitute production.
- Residential use: Use of a pesticide directly: (1) On humans or pets, (2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or (3) In any preschool or day care facility.
Summary of requirements
- Understand the exclusions and exemptions at 40 CFR 152.
- Obtain an EPA Company Number before registering your first product with EPA. (Refer to the existing EPA Company Number for subsequent registrations.)
- Obtain an EPA Establishment Number (using EPA Form 3540-8) if you are a pesticide producer who plans to register your own products.
- To begin the process of registering a new pesticide, new formula, or new use for an existing pesticide see 40 CFR 152.40 to 152.55 and:
- Complete and submit an original Application for Pesticide Registration/Amendment form (EPA Form 8570-1).
- Complete and submit two copies of a Confidential Statement of Formula (EPA Form 8570-4) with each application for registration.
- Determine if a fee is required and, if so, identify the amount and pay the fee when you submit your application (only applications received with a certification of payment will enter the review process):
- Documentation or certification of fee payment should be the first page of or on the front of an application. (Certification of payment may be: a copy of the check or pay.gov acknowledgement; or a request for an exemption from registration service fees.)
- Small business and minor use fee reductions or waiver requests should accompany the certification of payment as a document that can be separated from the rest of the application.
- Applicants are required to pay the agency 25 percent of the applicable fee even if an application is withdrawn or rejected for failure to pay a fee.
- Comply with the individual registration requirements imposed by the states in which they wish to market their product.
- Submit the annual maintenance fee described in FIFRA Section 4(i)(5), if required. (Affected applicants will be contacted by mail in November with instructions for submitting the fee, which is due by January 15.)
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['Pesticides']
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Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.