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focus-area/environmental/pesticides
555795207
area/pesticides
555164670
['Pesticides']

The term “pesticides” includes pesticides, herbicides, rodenticides, antimicrobial products, biopesticides, and other substances used to control a wide variety of pests. Most pesticides may legally be sold in the United States if they have been “registered” by the Environmental Protection Agency (EPA) and bear an EPA registration number. EPA regulates the registration, labeling, import/export, management, and use of pesticides to ensure they do not pose unreasonable risks to the public or environment. The agency also has regulations that protect certain workers and handlers from occupational exposures to pesticides.

Pesticides

  • EPA is charged with ensuring that pesticides do not pose unreasonable risks to the public and to the environment.

Pests

Plants, insects, mold, mildew, rodents, bacteria, and other organisms are a natural part of the environment. They can benefit people in many ways, but they can also be pests. Residential and commercial locations are often hosts to common pests, such as cockroaches, fleas, termites, ants, mice, rats, mold, or mildew. Weeds, hornworms, aphids, and grubs can be a nuisance outdoors when they get into a lawn, garden, crop, or fruit and shade trees. Pests can also be a health hazard to people and animals.

Pest control

The good news is nowadays, there are many different pest control methods. Sometimes a non-chemical method of control is as effective and convenient as a chemical alternative. Fixing leaks, storing food in containers, controlling pest access, cleaning up garbage, and mowing the lawn high and often are good ways to prevent pests. Trapping rats and mice, swatting insects with a flyswatter, mulching gardens, and hoeing or hand-picking weeds are other manual ways of controlling pests.

However, sometimes the best solution to a pest problem is a chemical treatment — using a pesticide. Technically, the term “pesticides” includes pesticides, herbicides, rodenticides, antimicrobial products, biopesticides, and other substances used to control a wide variety of pests. Simply put, a “pesticide product” is a pesticide that is (or is intended to be) distributed or sold.

The trouble is many pesticide products can be hazardous to people, especially when stored, handled, applied, or disposed of improperly. For this reason, a pesticide product label is of utmost importance to the end user and informs him or her how to use and apply the product to achieve the product’s purpose while protecting both human health and the environment. Unlike general use (or unclassified) pesticides, “restricted use pesticides” can only be used by a certified applicator or someone under the certified applicator’s direct supervision.

Pesticides are regulated

The Environmental Protection Agency (EPA) is charged with ensuring that pesticides do not pose unreasonable risks to the public and to the environment. EPA has authority under the law to regulate the use of pesticides. Most pesticides may legally be sold in the United States if they have been “registered” by EPA and if they bear an EPA registration number. Federal pesticide registration, however, is only the first step in preventing pesticide risks. Other regulations call for proper pesticide labeling, effective pesticide management, restricted use of certain pesticides, and the protection of agricultural workers from pesticide hazards, for example. EPA also regulates pesticide residues on food and pesticide imports and exports and has other responsibilities under the law.

State agencies, too, may regulate and enforce pesticide laws and regulations for their jurisdictions. In general, states have primary authority for compliance monitoring and enforcing against illegal pesticide use. Often, a state’s department of agriculture has this responsibility, but it can be a state’s environmental or other agency. Anyone applying pesticides must comply with federal and state laws.

What are pesticides?

  • A pesticide is 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.
  • The term pesticide product is another term defined by EPA, and pesticide products contain both active and inert ingredients.

A “pesticide” is 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. See the technical definition of the term pesticide at 40 CFR 152.3.

“Pesticide product” means 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. Pesticide products contain both “active” and “inert” ingredients:

  • An “active ingredient” prevents, destroys, repels, or mitigates a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer.
  • All other ingredients are called “inert ingredients” by federal law. They are important for product performance and usability.

Active ingredients

Active ingredients are the chemicals in a pesticide product that act to control the pests. Active ingredients must be identified by name on the pesticide product’s label together with its percentage by weight.

There are several categories of active ingredients:

  • Conventional — All ingredients other than biological pesticides and antimicrobial pesticides.
  • Antimicrobial — Substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms, whether bacteria, viruses, or fungi, on inanimate objects and surfaces.
  • Biopesticides — Types of ingredients derived from certain natural materials.

Inert ingredients

Pesticide products contain at least one active ingredient and other intentionally added ingredients. Called inert ingredients by the federal law, they are combined with active ingredients to make a pesticide product. Inert ingredients are chemicals, compounds, and other substances, including common food commodities (e.g., certain edible oils, spices, or herbs) and some natural materials (e.g., beeswax or cellulose).

The name “inert” does not mean non-toxic. All inert ingredients must be approved by the Environmental Protection Agency (EPA) before they can be included in a pesticide. EPA reviews safety information about each inert ingredient before approval. If the pesticide will be applied to food or animal feed, a food tolerance is required for each inert ingredient in the product, and the agency may limit the amount of each inert ingredient in the product.

Inert ingredients play key roles in pesticide effectiveness and product performance. Examples of functions that inert ingredients can serve include:

  • Acting as a solvent to help the active ingredient penetrate a plant’s leaf surface;
  • Improving the ease of application by preventing caking or foaming;
  • Extending the product’s shelf-life;
  • Improving safety for the applicator; and
  • Protecting the pesticide from degradation due to exposure to sunlight.

Under federal law, the identity of inert ingredients is confidential business information. The law does not require manufacturers to identify inert ingredients by name or percentage on product labels. In general, only the total percentage of all inert ingredients is required to be on the pesticide product label.

Intended use

It should be noted that EPA says that it is the “intended use” of a product that determines if it is a pesticide. If a company can answer “yes” to the any of the following questions, the product is a pesticide:

  • Claims — Does the product’s label or distributor claim that the product can or should be used as a pesticide?
  • Composition — Is the product composed of one or more active ingredients that have no commercially valuable use other than for a pesticidal purpose?
  • Knowledge that the substances will be used as a pesticide — Does the distributor know that the product will be used for a pesticidal purpose?

Other key definitions

  • Various terms are crucial to understanding pesticide laws and regulations.

Active ingredient: The ingredient that prevents, destroys, repels, or mitigates a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer.

Antimicrobial pesticide: A substance or mixture of substances that destroys or suppresses the growth of disease-causing microbes and pathogens including bacteria, viruses, or fungi.

Appurtenance: Any equipment or device which is used for the purpose of transferring a pesticide from a stationary pesticide container or to any refillable container, including but not limited to, hoses, fittings, plumbing, valves, gauges, pumps, and metering devices.

Biopesticides: Naturally occurring substances that control pests (i.e., biochemical pesticides), microorganisms that control pests (i.e., microbial pesticides), and pesticidal substances produced by plants containing added genetic material (i.e., plant-incorporated protectants (PIPs)).

Crop advisor: Any person who is assessing pest numbers or damage, pesticide distribution, or the status or requirements of agricultural plants. The term does not include any person who is performing hand labor tasks.

Early entry: Entry by a worker into a treated area on the agricultural establishment after a pesticide application is complete, but before any restricted-entry interval for the pesticide has expired.

Fumigant: Any pesticide product that is a vapor or gas, or forms a vapor or gas on application, and whose method of pesticidal action is through the gaseous state.

Inert ingredients: Ingredients in a pesticide that do not act as active ingredients.

Label: Any text or images printed directly on, or attached to, a pesticide product or its packaging.

Labeling: The label on a pesticide product, as well as any printed or written material that accompanies the product (for example, a booklet or manual). Labeling can also include material to which the label (or other labeling material) refers.

Minimum risk pesticide: A pesticide that poses little to no risk to human health or the environment and is therefore exempted by the Environmental Protection Agency (EPA) from the requirement that it be registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Restricted-entry interval: The time after the end of a pesticide application during which entry into the treated area is restricted.

Restricted use pesticide: A pesticide that is classified for restricted use under the provisions of FIFRA 3(d) and 40 CFR 152 Subpart I.

Rinsate: The liquid resulting from the rinsing of the interior of any equipment or container that has come in direct contact with any pesticide.

Rodenticide: A pesticide or poison used to kill rodents such as rats and mice. Common types of rodenticides include anticoagulant compounds as well as bromethalin, cholecalciferol, and zinc phosphide.

Runoff: Surface water leaving the target site.

Secondary containment unit: Any structure, including rigid diking, that is designed and constructed to intercept and contain pesticide spills and leaks and to prevent runoff and leaching from stationary pesticide containers.

Soil fumigants: Pesticides that are applied to soil that form a gas to control pests that live in the soil and may disrupt plant growth and crop production.

Toxicity: The property of a pesticide that refers to the degree to which the pesticide, and its degradates and metabolites, can cause an adverse physiological effect on an organism.

Laws and regulations that apply to pesticides

  • Several laws and regulations relate to pesticides.

Federal pesticide laws and statutes

  • Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. — FIFRA provides for federal regulation of pesticide distribution, sale, and use, and requires all pesticides sold or distributed in the United States (including those that are imported) to be registered by the Environmental Protection Agency (EPA). This also covers labeling requirements and risk assessments by EPA.
  • Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq. — The FFDCA authorizes EPA to set tolerances (i.e., maximum limits) for pesticide residues on foods. To determine tolerances, EPA must deem the tolerance “safe,” which is defined as “reasonable certainty that no harm will result from aggregate exposure to the pesticide residue.” EPA may grant exemptions to tolerance requirements in some cases.
  • Food Quality Protection Act (FQPA), Public Law 104–170 — This law amended both FIFRA and FFDCA, which introduced additional factors EPA must consider in establishing pesticide tolerances on food or feed and directed the agency to review each pesticide registration at least once every 15 years.
  • Pesticide Registration Improvement Act (PRIA), Public Law 108–199 — Also amending FIFRA and FFDCA, PRIA established service fees for registration of pesticides as well as decision review time periods for EPA.

Federal pesticide regulations

Federal EPA regulations implementing the pesticide laws and statutes can be found at 40 CFR Parts 150 to 189. These regulations establish policies, requirements, and procedures. They include, but are not limited to:

  • Part 152: Pesticide Registration and Classification Procedures
  • Part 155: Registration Standards and Registration Review
  • Part 156: Labeling Requirements for Pesticides and Devices
  • Part 162: State Registration of Pesticide Products
  • Part 165: Pesticide Management and Disposal
  • Part 168: Statements of Enforcement Policies and Interpretations
  • Part 170: Worker Protection Standard
  • Part 171: Certification of Pesticide Applicators
  • Part 180: Tolerances and Exemptions for Pesticide Chemical Residues in Food

Other laws and regulations applicable to pesticides

  • Endangered Species Act (ESA), 16 U.S.C. 1531 et seq. — The ESA is directed toward the conservation of threatened and endangered plants, animals, and habitats. EPA must consider whether the registration of any pesticide will further endanger any listed species and/or destroy or adversely change any critical habitat for those species.
  • Hazard Communication Standard, 29 CFR 1910.1200 — Pesticides present a potential workplace hazard to employees, and these hazards must be communicated via information made available to employees via safety data sheets.
  • Standards for Universal Waste Management, 40 CFR 273 — Pesticides are one of five hazardous wastes that may be managed as universal waste under federal EPA regulations. Note, however, that many states are authorized to manage waste regulations in their states, and not all states recognize pesticides as universal waste.

State and local rules and regulations — Check state and local environmental regulations to determine additional or more stringent requirements that may apply. The National Pesticide Information Center (NPIC) website provides a list of local contacts for pesticide information across U.S. states and territories.

Pesticide registration and labeling

  • A manufacture must register a pesticide before it can sell it in the United States.
  • A proposed pesticide label must be submitted with the pesticide registration application.

Before manufacturers can sell pesticides in the United States, EPA must evaluate them thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA will grant a registration that permits a pesticide’s distribution, sale, and use only after the company meets the scientific and regulatory requirements.

As part of any pesticide registration application submitted to EPA, applicants must provide a proposed label containing detailed information. During its review, the agency may approve the label as submitted, approve the label with comments, or disapprove the submitted label.

Summary of requirements

Cited under 40 CFR 152 to 156, registration and labeling requirements include:

  • Submitting a Pesticide Registration Notice to begin the process of registering a new pesticide, new formula, or new use for an existing pesticide.
  • Completing and submitting an original Application for Pesticide Registration/Amendment form.
  • Paying fees with application submission.
  • Obtaining an EPA Company Number before submitting a first product with EPA. (For subsequent registrations, refer to the existing company number.)
  • Obtaining an EPA Establishment Number using EPA Form 3540-8, if a pesticide producer plans to register its own products.
  • Submitting a master label to EPA for review and approval.

Pesticide registration

  • 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.
  • Determine if a fee is required and, if so, identify the amount and pay the fee when submitting the application.

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. 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 40 CFR 152.30.

Under the registration review process, 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.

Summary of requirements

  • Understand the exclusions and exemptions at 40 CFR 152.
  • Obtain an EPA Company Number before registering the 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 a pesticide producer who plans to register its 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 submitting the 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 acknowledgment; 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 a product is to be marketed.
  • 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.)

Company and establishment numbers

  • A “company number” is a unique identifier assigned to a company that wishes to register a pesticide with the EPA.
  • Registrants must obtain a company number prior to registering their first product with EPA.

A “company number” is a unique identifier assigned to a company that wishes to register a pesticide (e.g., herbicide, rodenticide, or antimicrobial) with the Environmental Protection Agency (EPA). A company number is also necessary for a company that plans to produce pesticides or devices. Such production requires the company to obtain a “Pesticide-Producing or Device-Producing Establishment Number.” The company number is part of the establishment number.

How to obtain an EPA company number

Registrants must obtain a company number prior to registering their first product with EPA. For subsequent products or amendment to existing registrations, the registrant must refer to this company number. (Note: Registrants who plan to produce their own products will also need to obtain an “establishment number.”)

The registrant must submit a signed letter on company letterhead to request a company number and establish an official address with EPA as described in the agency’s guidance, “How to Obtain a Company Number and Register an Official Address.” EPA will direct all future correspondence to the official address. The registrant must keep this official address record up to date.

In its request for a company number, a foreign company must designate a U.S. agent to receive correspondence and represent it in matters concerning an application. A U.S. registrant may also designate an agent. The letter should include a statement authorizing the agent to act in all matters concerning the registration of the product with EPA. It should also include a statement acknowledging that all official correspondence from EPA will be directed to the agent.

The request for a new company number can be made via email with the signed letter on company letterhead (including all needed information) as an attachment.

How to obtain an EPA establishment number

When producing or formulating a pesticide, it is necessary to register the place or facility where the pesticide or device will be produced. To register an establishment, EPA Form 3540-8, Application for Registration of Pesticide-Producing Establishments must be completed and submitted to EPA as follows:

  • For domestic establishments, the completed application should be sent to the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. The instructions for Form 3540-8 list the Regional Offices’ mailing addresses and telephone contacts.
  • For foreign establishments, applications should be submitted to EPA headquarters at the address listed in the instructions on how to properly complete Form 3540-8.

To request termination of a pesticide-producing or device-producing establishment, domestic establishments should notify the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. Foreign establishments should notify the EPA Headquarters Office listed in the instructions for Registering Establishments on the EPA website.

Registration application overview

  • Companies must submit an application for a registration action.

Companies must submit an application for a registration action, such as to register a new pesticide active ingredient, new product for an existing pesticide, or a new use for an existing product.

The company’s application typically includes:

  • A service fee;
  • Forms describing the requested action;
  • The identity and quantity of all chemicals in the product;
  • Data on potential risks to human health and the environment, including about the potential for pesticide residues on food (if applicable);
  • Proof that the product manufacturing process is reliable;
  • Labeling, including directions for use, contents, and appropriate warnings; and
  • Evidence of meeting all legal and financial obligations.

EPA publishes a notice of receipt in the Federal Register for each application for registration of a new product that contains a new pesticide active ingredient or that proposes a new use for an existing pesticide.

Applications are assigned to the appropriate pesticide division, where it is processed and tracked. An agency project manager is then assigned to:

  • Complete a detailed review of the application;
  • Assign and coordinate the appropriate scientific review;
  • Implement priorities and timetable as set by law;
  • Coordinate administrative action; and
  • Communicate with the applicant, otherwise known as the registrant, about the review.

Registration procedures

  • A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package.
  • EPA welcomes requests for a pre-registration meeting.
  • PR Notice 11-3 discusses both the recommended and the required procedures for submitting FIFRA data.

Procedures for submitting a complete application for registration of a pesticide product are detailed in regulations at 40 CFR 152.40 to 152.55. The Environmental Protection Agency (EPA) has also published the Pesticide Registration Manual as a resource for companies and individuals who want to have their pesticide products registered for sale in the United States. Detailed information for pesticide registrants (i.e., the company or individual applying to register a pesticide) concerning their responsibilities before, during, and after the review process is included in the manual, which can be found on the agency’s website.

A separate application for registration must be made for each pesticide product that will be distributed or sold. A pesticide product registration is required for each manufacturing use product or end use formulation.

Note: EPA has classified some or all of the uses of certain pesticides as “Restricted Use.” The “Restricted Use” classification restricts a product, or its uses, to use by a certified pesticide applicator or under the direct supervision of a certified applicator. Criteria used for determining whether a product requires the restricted use classification can be found in 40 CFR 152.170.

Cover letter

A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package. It should also contain the email address of the applicant in order to receive registration milestone tracking emails.

Application form

Complete and submit an original Application for Pesticide Registration/Amendment Form (EPA Form 8570-1) with each application for registration. When EPA receives the application (and the applicable fee required), the agency will screen the application during a 21-day period to determine if it contains all required forms, labeling, and data formatted as described in the agency’s guidance in Pesticide Registration (PR) Notice 11-3, as well as documentation of fee payment.

The fee payment documentation may include a request for a fee reduction or waiver or an exemption. Any deficiencies identified during the 21-day screening that are not corrected by the applicant may lead to the agency’s rejection of the application. EPA will keep 25 percent of the fee.

Pre-registration meeting

EPA welcomes requests for a pre-registration meeting. This type of meeting can provide useful guidance to the applicant regarding information needed for registration. Applicants are encouraged to contact the appropriate branch assigned to the active ingredient in their product before submitting an application for registration. Contact the ombudsman for the division if the appropriate branch is unknown.

Pesticide Registration (PR) Notice 11-3

PR Notice 11-3 discusses both the recommended and required procedures for submitting Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data. All required procedures contained within the document, generally indicated by use of the word “must,” were previously made mandatory by statute or regulation. Where indicated by the use of non-mandatory language such as “may,” “should” and “can,” EPA provides recommendations or guidance.

The PR Notice applies to all data that are submitted to EPA to support any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:

  • Application for registration or amended registration of a pesticide product under FIFRA 3 or 24.
  • Submission of data required in conjunction with reregistration of a currently registered product under FIFRA 4 (or its registration review under FIFRA 3).
  • Application for an experimental use permit under FIFRA 5.
  • Submission of data in response to a notice issued by EPA under FIFRA 3(c)(2)(B).
  • Petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under Federal Food, Drug and Cosmetic Act (FFDCA) 408.
  • Studies submitted under FIFRA 6(a)(2).

Electronic submissions

Applications for pesticide registration can now be submitted electronically to EPA. Forms, studies, and draft product labeling may all be submitted via the Pesticide Submission Portal (PSP) which is accessed through EPA’s Central Data Exchange (CDX) Network (user registration is required). Application materials, tools, and resources for submission are all available on EPA’s website. Registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools based on EPA’s XML guidance may use the PSP and forego the costs of sending physical copies to EPA.

Note that applicants do not need to submit multiple electronic copies of any pieces of their applications. In PR Notice 2011-3, EPA made clear that the requirement to submit multiple copies of data is applicable only to paper submissions and, similarly, EPA interprets the requirement to submit five copies of draft labeling in 40 CFR 152.50(e) to apply only to applications made on paper. Since electronic submissions are easily reproducible, EPA will accept electronic applications containing one copy of all the required elements.

Registration fees

  • A fee (or a waiver from paying the fee) is required for certain types of actions.
  • Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.
  • All registrations are subject to an annual maintenance fee.

The Environmental Protection Agency (EPA) keeps a fee schedule current on its Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) webpage. This is the first stop for determining the application fee amount.

A fee (or a waiver from paying the fee) is required for the following types of actions:

  • New active ingredients;
  • New uses;
  • New products;
  • Certain tolerances;
  • Certain amendments;
  • Certain inert ingredients;
  • Certain combination products;
  • Cancer reassessments and certain ecological/endangered species assessments;
  • Manufacturing use products (MUPS);
  • Experimental use permits (EUPS);
  • Human study protocols and completed studies that require review by the human studies review board;
  • Certain covered actions that require external review by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) science advisory panel;
  • Gold Seal letters; and
  • Data extension requests.

FIFRA 33(b)(2)(F) directs the agency to reject any application submitted without the required registration service fee. Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.

A certification of payment should be the first page of the submission or application and precede a cover letter or fee waiver or reduction request to enable the agency to match a payment with an application.

To help applicants identify the appropriate fee and pay it in advance of submitting an application (pre-payment) or upon submission to EPA, the “Fee Determination Decision Tree” is available on the agency website. Through a series of questions and answers, pesticide registration applicants are led to the appropriate fee category and fee.

Also, chapter 5 of the Pesticide Registration Manual offers in-depth information about registration fees.

Annual pesticide registration maintenance fees

All registrations are subject to an annual maintenance fee. Affected applicants will be contacted by mail in November with instructions for submitting the fee, which is due by the fifteenth of January. No extensions of this due date are possible. The amount of the per product fee will vary from year to year as the fee is dependent upon the projected number of products for which registrants will pay this fee.

Although there are procedures for requesting a fee waiver for individual products, maintenance fees will be reduced by 25 percent for the first registration only, if the applicant can show that:

  • The applicant has 500 or fewer employees globally,
  • During the three-year period prior to the most recent maintenance fee billing cycle the applicant has average annual gross revenue from all sources that do not exceed $10,000,000, and
  • The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet certain narrow criteria in two categories: minor agricultural use products and public health pesticides.

EPA assessment

  • EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use are necessary to protect the environment.
  • EPA uses a four-step process for its human health risk assessments.
  • As a final step of evaluation, EPA implements an overall risk assessment and peer review.

The Environmental Protection Agency (EPA) evaluates new pesticides before they can enter the market and re-evaluates existing pesticides to ensure they continue to meet appropriate safety standards.

Ecological risk assessment

EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use or proposed use are necessary to protect the environment. Many plant and wildlife species can be found near or in cities, agricultural fields, and recreational areas. Before allowing a pesticide product to be sold on the market, EPA ensures that the pesticide will not pose any unreasonable risks to plants, wildlife, and the environment. This is done in phases:

  • Planning phase: Planning and scoping process — EPA begins the process of ecological risk assessment with planning and research.
  • Phase 1: Problem formulation — Information is gathered to help determine what plants and animals are at risk and need to be protected.
  • Phase 2: Analysis — This is the determination of what plants and animals are exposed and to what degree they are exposed, and whether or not that level of exposure is likely to cause harmful ecological effects.
  • Phase 3: Risk characterization — Risk characterization includes two major components (risk estimation and risk description). Risk estimation combines exposure profiles (i.e., the findings of exposure characterization) and effects from exposure. Risk description provides information important for interpreting the risk results and identifies a level for harmful effects on the plants and animals of concern.

Human risk assessment

A human health risk assessment is the process to estimate the nature and probability of adverse health effects in humans who may be exposed to chemicals in contaminated environmental media, now or in the future. Human health risk assessments address questions such as:

  • What types of health problems are caused by pesticides in the environment?
  • What is the chance that people will experience problems when exposed to different levels of pesticides?
  • Is there a low level below which some chemicals don’t pose a human health risk?
  • What pesticides are people exposed to and for how long?
  • Are legal limits for pesticide residues in food (tolerances or maximum residue limits) protective of human health?
  • Are people more likely to be susceptible or exposed to pesticides because of factors such as age, genetics, pre-existing health conditions, ethnicity, gender, where they work, where they play, what they eat, etc.

EPA uses the National Research Council’s four-step process for its human health risk assessments:

  1. Hazard identification examines whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances.
  2. Dose response assessment examines the numerical relationship between exposure and effects.
  3. Exposure assessment examines what is known about the frequency, timing, and levels of contact with a substance.
  4. Risk characterization examines how well the data support conclusions about the nature and extent of the risk from exposure to pesticides.

Cumulative risk assessment

The Food Quality Protection Act of 1996 requires EPA to also conduct a cumulative risk assessment for pesticides that have a common mechanism of toxicity. A common mechanism of toxicity is identified when two or more chemicals or other substances cause a common toxic effect(s) by the same, or essentially the same, sequence of major biochemical events.

Final assessment and review

As a final step of evaluation, EPA implements an overall risk assessment and peer review. The agency reviews all the scientific data on the pesticide product and develops comprehensive risk assessments that examine the potential effects of the product or ingredients on the human population and environment. Health and environmental risk assessments undergo a process of peer review by scientific experts.

EPA risk management and regulatory decisions

  • After completing its risk assessments and peer review, EPA makes risk management and regulatory decisions.

After completing its risk assessments and peer review, the Environmental Protection Agency (EPA) makes risk management and regulatory decisions to:

  • Consider the results of the risk assessments and the peer review;
  • Research alternative pesticides that are already registered;
  • Review any measures needed to mitigate any identified risks;
  • Discuss with the applicant if modifications to the product or labeling must be made to mitigate risk;
  • Establish new food tolerances if needed, after publishing notices for comment in the Federal Register;
  • Reject or grant the registration; and
  • Publish in the Federal Register a notice of issuance of the registration, if granted.

Required initial/annual reporting

For new establishments, an initial report must be submitted no later than 30 days after the first registration of each establishment. The records that must be maintained and the retention period are described in 40 CFR 169.

All active establishments are required to submit an annual production report on Environmental Protection Agency (EPA) Form 3540-16, Pesticide Report for Pesticide-Producing Establishments by March 1 of each year to the appropriate EPA Regional Office listed in the “Instructions for Completing EPA Form 3540-16.”

Pesticide labels and labeling

  • Unlike most other types of product labels, pesticide labels are legally enforceable.

Pesticide product labels and labeling provide critical information about how to safely and legally handle and use pesticide products. A pesticide product’s label and labeling are of utmost importance as they are the primary mechanism to inform the end-user about how to use and apply the product to achieve the product’s useful functions, as well as which precautions must be followed to protect both human health and the environment.

Label versus labeling

A pesticide “label” includes any text or images printed directly on, or attached to, the product or its packaging. “Labeling,” on the other hand, includes the label, as well as any printed or written material that accompanies the product (for example, a booklet). Labeling can also include material to which the label (or other labeling material) refers. For instance, if a label refers to a manual on how to conduct a procedure, that manual is also labeling that the user must follow and the Environmental Protection Agency (EPA) must review and approve before the product may be sold or distributed.

The label is the law

Every pesticide product must bear a label containing the information specified by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S. Code section 136 et seq., and its implementing regulations at 40 CFR 156. FIFRA and Part 156 govern what must be included on pesticide labels.

Unlike most other types of product labels, pesticide labels and labeling are legally enforceable, and all of them carry the statement: “It is a violation of federal law to use this product in a manner inconsistent with its labeling.” One could say, “The label is the law.” Enforcement of pesticide regulations and label requirements is primarily carried out by state agencies acting under cooperative agreements with EPA.

Label review and approval

As part of any pesticide registration application submitted to EPA, applicants must provide a proposed label containing detailed information. The agency ensures that the pesticide label translates scientific data about the potential health and environmental effects of a pesticide into a set of conditions, directions, precautions, and restrictions that define who may use a pesticide, as well as where, how, how much, and how often it may be used.

During its review, EPA may approve the label as submitted, approve the label with comments, or disapprove the submitted label. The label must be approved before a pesticide can be sold or distributed in the United States.

Ultimately, the accuracy of a label is vital as it may impact:

  • EPA and other agencies that use the label to manage and mitigate pesticide risks;
  • EPA and other agencies that enforce pesticide production, distribution, and use;
  • Registrants, including pesticide manufacturers, and their supplemental distributors;
  • Pesticide applicators who rely on the label for hazard and safety information and use directions to ensure safe and effective use;
  • Bystanders and other individuals who may be exposed to the pesticide; and
  • Courts that consider a label to be a legal document.

Summary of requirements

  • Determine whether the product is or is not a pesticide. See 40 CFR 152.
  • Determine whether the product is exempted from FIFRA. See 40 CFR 152.
  • Determine whether the pesticide product is exempted from registration. See 40 CFR 152.
  • If the pesticide product is unregistered and non-exempt, then it is not exempted from registration:
    • Develop draft labeling that meets the Part 156 requirements, including for content and format.
    • Follow the application procedures at 152.50 for submitting applications and draft labeling. Submit five copies of the proposed draft labeling with an application. The draft labeling may be typed or otherwise printed but must be legible, reproducible, and on 8-1/2 x 11-inch paper. However, EPA encourages electronic submission. See the EPA Electronic Submission of Labels webpage for information.
    • EPA will review draft labeling submitted with the application and can approve the label as submitted, approve the label with comments, or disapprove the submitted label.
    • Once EPA has granted a registration, EPA not only notifies the registrant of the decision but also will approve a submitted label for the product.
    • Include an approved label on every package on all registered products.
    • Do not alter or change the label after the registration approval. If the product was previously registered with EPA and a change to the registration, such as a change to the labeling text, is needed, file an application to amend the registered product.
    • Do not sell or distribute a pesticide if any claims made for it differ from the claims made on labeling required for registration. (Advertising claims for a pesticide product must not contradict claims made in the product’s labeling.)
  • Ensure that supplemental distributor products and their distributor labeling comply with 152.132. Distributor labels are not submitted for approval, but a Notice of Supplemental Distribution must be submitted to EPA before supplemental distribution of the product. A distributor label must be the same as that of the registered product label with some important exceptions.

Guidance

Given the high importance of labels in pesticide management, application, and regulatory enforcement, EPA has compiled a comprehensive Label Review Manual (LRM), which is available on the agency website. This instructional aid compiles existing interpretations of statutory and regulatory provisions and reiterates existing agency policies. The LRM also provides assistance and insight into how pesticide labels should generally be drafted.

Further regulatory guidance may be found in EPA Pesticide Registration Notices (PR Notices or PRN).

Types of labels/labeling

  • Master label, sub-label, supplemental distributor labeling, and supplemental labeling are the four types of pesticide labels and labeling.

There are four types of pesticide labels and labeling:

  • Master label,
  • Sub-label (split-label),
  • Supplemental distributor labeling, and
  • Supplemental labeling.

Master label

The master label displays the claims and directions for the approved uses of a given product and all associated required labeling. All other labeling for the product must not contain any text beyond that which is approved in the master label (with the exception of the supplemental label).

This label is filed with the Environmental Protection Agency (EPA) once it is stamped “accepted.”

Sub-label (split-label)

A sub-label or split-label displays the claims and directions for only a portion of the approved uses under a given master label. The label is complete, listing all of the required label elements, but the company may want the label displayed differently for marketing purposes. EPA allows registrants to distribute or sell a product under a sub-label or split-label provided that no changes would be necessary to the precautionary statements, use classification, or packaging of the product.

A sub-label or split-label only contains labeling text that also appears on the master label. When a sub-label is submitted with additions not on the accepted master label, a new master label containing all the uses currently approved under the product’s registration is required. Only the master label will be stamped “accepted.”

Supplemental distributor labeling

Supplemental distributor labeling includes labels for a product that is registered to one company but distributed by another company (sometimes referred to as a “sub-registrant”) under that company’s name. These labels must be the same as the labels for the registered product, with the following exceptions:

  • Product name
  • Name and address
  • Registration number (EPA Reg. No. xxxx-xx-xxxx, where the third set of numbers refers to the distributor’s company number)
  • Establishment

In addition, claims may be deleted, but new claims that differ from the parent label cannot be added to a distributor label.

The parent company must notify EPA before distribution by submitting a Notice of Supplemental Distribution (EPA Form 8570-5).

EPA does not receive or review supplemental distributor labeling, but EPA can review the distributor company names to ensure that they are not misleading. The parent company is responsible for ensuring that the supplemental distributor is in compliance with these requirements.

Supplemental labeling

Supplemental labeling includes labels that contain newly approved uses, use directions, or other instructions that have been added since the last accepted master label. These new uses and directions are incorporated into the EPA master label, but because they are not on those products already in the channels of trade, they are distributed with the product by the registrant or distributors.

These are partial labels, so they must include a statement referring the user to the product label for complete directions and precautions, and a statement that the labeling must be in the possession of the user. The user must follow the supplemental label, the product’s container label, and all other labeling that comes with the product in order to apply it in a way that reduces risk and maximizes efficacy.

The supplemental labeling must be submitted and stamped “accepted” by EPA prior to distribution. EPA requires that these labels include the following information:

  • Product name
  • EPA registration number
  • Restricted use classification statement (if applicable)
  • “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”
  • “The labeling must be in possession of the user at the time of application.”
  • “Read the label affixed to the container for [product name] before applying.”
  • “Use of [product name] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [product name].”

Normally, supplemental labeling will be incorporated into the affixed label at the next printing of the product label or within 18 months. The agency recommends an expiration date of 18 months after acceptance on supplemental labels. However, this might not be done in all cases, such as if the directions for use are subject to continual, frequent change.

Labels that require review

  • Various types of labels require EPA review, as discussed here.

Labels for products containing new active ingredients and/or new uses — This type of submission involves a new active ingredient that is currently not registered by the Environmental Protection Agency (EPA) as a pesticide or a new use of an existing product.

Labels for new products containing existing active ingredients — This type of submission involves an application for registration of a product containing an active ingredient that is currently registered for use as a pesticide in other products.

Labels for technical grade and manufacturing use products — This type of submission involves a product that is used to manufacture or formulate other pesticides.

Labels for products requiring amendments — This type of submission involves an application for an amendment to a currently registered pesticide. There are two kinds of amendment submissions:

  • No data review required. An example is an amendment for the addition to the label of a new site or pest that has been previously approved by EPA for other products containing the same active ingredient. For products composed of multiple active ingredients, the proposed new site or pest must be previously approved for all of the active ingredients.
  • Data review required. An example is an amendment involving a new use, a new application rate, or a change in precautionary statements. This is an action not previously approved by EPA, and a data submission and review are necessary. Review of the label will be based on the conclusions of the data reviews from the product chemists, toxicologists, or efficacy reviewers. Generally, the specific reviews will only affect a small portion of the label; the rest of the text should remain unchanged from the originally accepted label.

Fast track labels — This type of submission involves no data or only product chemistry data.

Me-too registration labels — This type of submission involves a pesticide product and proposed use that is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.

Labels for products with efficacy data requirements — This type of submission involves products for which efficacy data is required. Efficacy studies document how well pesticide products perform as pest control agents. Even though registrants/applicants must conduct efficacy studies, the agency only routinely requires the submission of these studies for certain types of products. EPA reviews efficacy data (also referred to as product performance data) when a pesticide product bears a claim to control pest organisms that pose a threat to human health. Such pests include, but are not limited to:

  • Microorganisms that are infectious to humans in any area of the inanimate environment;
  • Vertebrates (e.g., rodents, birds, bats, and skunks) that may directly or indirectly transmit diseases to or injure humans; or
  • Insects that carry human diseases (e.g., mosquitoes and ticks).

Public health pests are listed in Pesticide Registration (PR) Notice 2002-1. EPA also requires submission of efficacy data to support claims for the control of termites. On a case-by-case basis, the agency may require substantiation of an efficacy claim.

Labels for special local need (SLN) products — This type of submission involves products for which particular states register additional uses to meet their specific needs. Such registrations are for distribution and use only within a particular state to meet an SLN. Unlike other labels, EPA does not actively accept SLN labels. Instead, EPA has 90 days to disapprove it; otherwise, it is considered an accepted label under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Experimental use permits — Experimental use permits authorize testing (across an area greater than 10 acres of land or one acre of water) of unregistered pesticides or registered pesticides’ unregistered uses.

Labels that do not require review

  • With supplemental distributor labeling, EPA reviews the parent company’s labeling, but not the distributor’s labeling.
  • Certain types of products are exempt from FIFRA because EPA determined them to be adequately regulated by another federal agency or of a character that is unnecessary to be subject to FIFRA.

Supplemental distributor labeling — This type of submission involves labels for a product that is registered to one company, but distributed by another company. The Environmental Protection Agency (EPA) reviews the parent company’s labeling, but not the distributor’s labeling. Supplemental distributor products are still subject to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA can review distributor company names to ensure that they are not misleading.

Labels for products exempted from FIFRA by 40 CFR 152.20 and 152.25 — Certain types of products are exempt from FIFRA because EPA determined them to be:

  • Adequately regulated by another federal agency, or
  • Of a character that is unnecessary to be subject to FIFRA, such as insect pheromones or products containing only certain listed ingredients EPA determined to pose minimum risks.

Labels for modified products requiring notification and non-notification — This type of submission involves product modifications that do not require EPA approval. These modifications must have no potential to cause unreasonable adverse effects to the environment. Some of these modifications can be made simply by notifying EPA (known as notification). Examples include:

  • Adding or changing alternate brand names,
  • Changing primary product name, or
  • Changing symbols and graphics (except skull and crossbones).

Other modifications may be made without notifying EPA (known as non-notification). Examples include:

  • Correcting typographical and printing errors,
  • Changing package size and net contents (with some exceptions), and
  • Changing name or address of registrant.

Label compliance and enforcement

  • There are four steps in the pesticide label review and enforcement process.
  • Imprecise or vague language can make a label misleading and unenforceable.

Label review

When conducting a label review, the Environmental Protection Agency (EPA) considers:

  • Whether a user can understand and follow the label; and
  • Whether the label is clear, accurate, and consistent with EPA policy and is enforceable by the states or EPA regions.

EPA can stamp a label as “accepted,” send the label back to the manufacturer for corrections, or begin an investigation to detect violations and/or collect evidence necessary to successfully prosecute violators.

Violation investigation

Inspectors can include representatives from state agencies, federally recognized tribes, and EPA regional offices. They may conduct inspections that are routine or “for cause,” which means they are the result of a complaint or tip. Inspectors may investigate retail establishments or pesticide dealers to see if products for sale are legal. They may also investigate use sites, such as farms, to see if misuse has occurred or if standards and labeling requirements for worker protection have been violated.

Laboratory analysis

If the investigation involves physical samples, the inspector collects those samples and submits them to a laboratory for analysis. A laboratory analyst:

  • Verifies formulation of samples.
  • May perform antimicrobial efficacy testing on samples.

Case development

To determine whether a violation has taken place, a case developer (or attorney) develops a case following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Enforcement Response Policy, as well as the administrative procedures set forth in the regulations. The case developer:

  • Reviews the inspector’s report.
  • Reviews the evidence.
  • Performs a word-for-word comparison of the accepted label and the label collected during the inspection.
  • May send an Enforcement Case Review (ECR) to the Office of Enforcement and Compliance Assurance (OECA) and Office of Pesticide Programs (OPP) to build a case. ECRs often include label interpretation questions.

If a problem is uncovered during the label review phase, a pesticide manufacturer or distributor can have a serious issue. Label problems can affect thousands of products or millions of units of one product already in the marketplace.

Language must be enforceable

Because the label is the law, imprecise or vague language can make a label misleading and unenforceable. If the label is not enforceable, then users who misuse a pesticide may not be prosecuted, and victims of a product’s misuse might not be compensated.

Pesticide imports and exports

  • Certain rules and regulations under FIFRA apply to the import and export of pesticides and pesticide devices, many of them related to registration and labeling.
  • Importers of all FIFRA-regulated pesticides and devices must comply with U.S. CBP regulations.

Certain rules and regulations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) apply to the import and export of pesticides and pesticide devices, many of them related to registration and labeling. The Environmental Protection Agency (EPA) also sets limits (known as “tolerances”) on how much pesticide residue may remain on food and feed products as well as other commodities, and these limits apply to those foods or commodities that are imported and exported.

EPA recommends that importers and exporters work with their legal counsel or enlist the aid of a pesticide regulatory consultant if they need additional assistance or clarification regarding these rules.

Importation of pesticides and related devices

  • Importers of all FIFRA-regulated pesticides and devices (including unregistered pesticides) must comply with the U.S. Customs and Border Protection (CBP) regulations set forth at 12 CFR 12.110 to 12.117.
    • Unregistered pesticides may be imported only if the import meets the conditions of one of the specific exceptions in 40 CFR 152.30.
    • Persons who are importing unregistered pesticides for the sole purpose of exporting them must comply with Pesticide Registration Notice 99-1.
  • No imported pesticide or device may be adulterated, misbranded, or otherwise violative of FIFRA.
  • All imported pesticides and devices, including unregistered pesticides, must have been produced in an EPA-registered establishment, even when the production establishment is outside the United States. The pesticide or device must also be labeled accordingly with that establishment number. The producer is responsible for submitting annual production reports to EPA.
  • Notice of Arrival of Pesticides and Devices (NOA). The CBP regulations implementing FIFRA 17(c)(1) prohibit the importation of pesticides without a completed EPA NOA. Upon entry of a shipment of pesticides or pesticide devices into the United States, and concurrent with the filing of the entry documentation, CBP must be in receipt of the information required by the EPA NOA. The EPA NOA information may be submitted on paper using EPA Form 3540-1 or electronically via any CBP-authorized electronic data interchange system. Importers and their agents are encouraged to file their EPA NOA information well in advance of their shipment’s arrival at the port of entry to allow time for EPA review, any requests for additional information, and any necessary corrections. More detailed information on the NOA filing options and procedures and tips for preventing common filing errors are available via the EPA-authored report Automated Commercial Environment (ACE) Tips and Guidelines for Filing EPA Notice of Arrival (NOA) for Pesticides and Devices, which can be found on CBP’s website.

Exportation of pesticides and related devices

  • Registered pesticides that are exported must bear labeling (or collateral labeling per 40 CFR 168.69) that is approved by EPA as part of its registration. For the requirements related specifically to the export of registered pesticides, see 40 CFR 168.69.
  • Unregistered pesticides. Pesticides intended solely for export are not required to be registered in the United States if the exporter complies with the labeling and other applicable requirements in 40 CFR 168.70 and 168.75, which in most cases will include the submission of a foreign purchaser acknowledgement statement (FPAS) to EPA. Additional information on how to file an FPAS can be found on the EPA pesticides website.
  • Pesticide devices that are exported must bear labeling (or collateral labeling per 40 CFR 168.69) compliant with 40 CFR 168.71.
  • All exporters of pesticides, devices, and active ingredients must also:
    • Keep records and permit inspections of those records in accordance with 40 CFR 169; and
    • Submit annual reports to EPA in accordance with 40 CFR 167.

Pesticide management

  • EPA requires that pesticide producers, distributors, or refillers follow the container specifications for nonrefillable and refillable containers.
  • EPA has authorized 21 states to implement their own pesticide containment regulations rather than the federal regulations.

Pesticides require special care and handling, and the Environmental Protection Agency (EPA) sets standards and requirements for pesticide containers, repackaging pesticides, and pesticide containment structures. The regulations on the management of pesticides, cited under 40 CFR 165, describes the requirements for refillable and nonrefillable containers and for properly disposing of pesticides.

In summary, EPA requires that:

  • Pesticide producers, distributors, or refillers follow the container specifications for nonrefillable and refillable containers.
  • If the company stores pesticides onsite, it must:
    • Keep pesticides in appropriate containers;
    • Provide necessary secondary containment;
    • Follow label directions;
    • Follow safety procedures; and
    • Dispose of pesticides according to federal, state, and local laws.

Pesticide containment

The pesticide container regulations establish standards for pesticide containers and repackaging as well as label instructions to ensure the safe use, reuse, disposal, and adequate cleaning of the containers. Pesticide registrants and refillers (who are often distributors or retailers) must comply with the regulations, and pesticide users must follow label instructions for cleaning and handling empty containers.

Pesticide retailers who repackage pesticides, commercial applicators, and custom blenders must comply with the pesticide containment regulations if they handle agricultural pesticides and have a stationary container or pesticide dispensing area that is covered by the regulations.

Note that EPA has authorized 21 states to implement their own pesticide containment regulations rather than the federal regulations. These states are: Colorado, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, South Dakota, Vermont, Washington, West Virginia, and Wisconsin.

Summary of pesticide container and containment structure regulations

The table below summarizes pesticide container and containment structure regulations:

CategoryWho must complyMajor requirements
Nonrefillable containers
  • Registrants
  • Department of Transportation (DOT) container design, construction, and marking standards
  • Container dispensing capability
  • Standard closures
  • Residue removal
  • Recordkeeping
Refillable containers
  • Registrants
  • Refillers (retailers, distributors)
  • DOT container design, construction, and marking standards
  • Serial number marking
  • One-way valves or tamper-evident devices
  • Stationary container requirements
Repackaging pesticide products
  • Registrants
  • Refillers (retailers, distributors)
  • DOT container design, construction, and marking standards
  • Serial number marking
  • One-way valves or tamper-evident devices
  • Stationary container requirements
Container labeling
  • Registrants
  • Pesticide users (must follow new directions)
  • Identify container as nonrefillable or refillable (all)
  • Statements to prohibit reuse and offer for recycling; batch code (all nonrefillables)
  • Cleaning instructions (some nonrefillables)
  • Cleaning instructions before final disposal (all refillables)
Containment structures
  • Ag retailers
  • Ag commercials applicators
  • Ag custom blenders
  • Secondary containment structures (dikes) around stationary tanks
  • Containment pads for pesticide dispensing areas
  • Good operating procedures
  • Monthly inspections of tanks and structures
  • Recordkeeping
  • Provisions for states with existing programs

Pesticide storage

  • Limit the amount of pesticide the company buys and stores to only what the company will use, sell, or distribute quickly.
  • Always store pesticides in their original containers with the original label attached.

For pesticides in small portable containers (such as 55-gallon drums or smaller containers), the Environmental Protection Agency (EPA) regulates pesticide storage through specific storage instructions on pesticide labels. Some states regulate the storage of pesticides in small portable containers, so be sure to check state regulations.

Storage best practices

  • Limit the amount of pesticide the company buys and stores to only what the company will use, sell, or distribute quickly.
  • When given the option, choose refillable containers and return them to the pesticide seller for refilling.
  • Read the pesticide label for specific storage and safety information.
  • Keep pesticide storage facilities away from humans and livestock and do not locate them in flood-prone areas.
  • Provide secondary containment when required.
  • Situate pesticide containers so that leaks and spills cannot reach drains, surface water, ditches, etc.
  • Secure pesticide storage areas to ensure no unauthorized entry.
  • Post storage areas with signs reading “DANGER – PESTICIDES – KEEP OUT”.
  • Do not store pesticides with incompatible pesticides or other chemicals.
  • Keep pesticides separate from food, drinking water, animal feed, seeds, etc.

Safety tips for pesticide storage areas

  • Always store pesticides in their original containers with the original label attached. However, if a pesticide container is leaking, transfer the chemical to a sturdy new container that can be sealed. Attach the original label to the new container or label the new container with specific information immediately.
  • Purchase only the quantities of pesticides required for a single season to minimize the need for off-season storage.
  • Keep the storage site neat and tidy. Pesticide handlers must be able to:
    • See pesticide labels,
    • Detect leakage or corrosion, and
    • Get to leaks or spills to clean them up.
  • Store protective equipment and clothing in a nearby location that provides immediate access but is away from pesticides and their fumes, dusts, or possible spills.
  • Provide an immediate supply of clean water and have an eyewash dispenser immediately available for emergencies. Soap and a first aid kit are also necessary.
  • Establish procedures to control, contain, and clean up spills. Familiarize everyone with the procedures.
  • Provide tools (like a shovel, broom, and dustpan) and absorbent materials (like clay, sawdust, or shredded paper) to clean up spills.
  • Mark pesticide containers with the date of purchase and rotate inventory to ensure that the oldest material is used first.
  • Keep the following:
    • An accurate, up-to-date stored pesticide inventory;
    • A file of product labels available for reference;
    • A file of safety data sheets (SDSs);
    • A building floor plan showing the exact location of pesticides; and
    • Emergency phone numbers at the storage area and in the office.
  • Maintain an inventory of all safety kits and signs.
  • Develop a fire emergency plan in consultation with the local emergency planning committee and fire, police, and sheriff’s departments. Notify the appropriate officials of the types of pesticides and quantities stored.
  • Know and follow state and local fire codes. Consult with local fire authorities regarding the best fire extinguishing agent — water, foam, dry chemical, carbon dioxide, etc.

Pesticide disposal

  • Containers that held acute hazardous wastes must be triple rinsed in order to be considered “RCRA-empty.”
  • Only certain pesticides are eligible for the universal waste program.

Pesticides are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) until they are disposed, after which they are regulated under the Resource Conservation and Recovery Act (RCRA), which ensures responsible management of hazardous waste and non-hazardous solid waste.

Many pesticides are listed or characterized as hazardous waste, or even acute hazardous waste, when disposed. If a pesticide is listed as having acute hazardous characteristics, even a small amount of pesticide waste can push a facility into the large quantity hazardous waste generator (LQG) category.

Containers that have held pesticides that are listed or characterized as a hazardous waste (either acute or nonacute) must be triple rinsed in order to be considered “RCRA-empty.” Be sure to collect any rinsate that was not used to create a spray mixture for use in application equipment and dispose of it properly in accordance with the product labeling and federal and state regulations.

However, note that in most states, pesticides can be managed as a universal waste, which streamlines the regulation of certain hazardous waste management.

Pesticides as universal waste

Only certain pesticides are eligible for the universal waste program at 40 CFR 273 or state equivalent regulation. These are:

  • Recalled pesticides that are suspended or canceled and part of a voluntary or mandatory recall under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); or
  • Unused pesticide products that are collected and managed as part of a waste pesticide collection program.

Check the state’s regulations, as some states (including California, Maine, and Washington) do not recognize pesticides as a universal waste.

Organizations that may handle pesticides under the Universal Waste Program must manage the waste in a way that prevents releases to the environment, use proper containers, adhere to all labeling requirements, and ship the pesticide(s) offsite to another universal waste generator or to a facility that is authorized to accept the pesticide within one year.

Triple rinsing

  • The procedure for rinsing containers should begin immediately after emptying the contents into the application equipment.
  • Triple and pressure rinsing pesticide containers are not viable options in certain situations.

Triple rinsing is defined by a 1974 federal regulation as the “flushing of containers three times, each time using a volume of the normal diluent equal to approximately ten percent of the container’s capacity, and adding the rinse liquid to the spray mixture.” Pesticide labels on metal, plastic, and glass containers reflect this federal definition when directing applicators to triple rinse or the equivalent.

Triple rinsing process

  1. The same personal protective equipment (PPE) worn while handling the pesticide concentrate during the mixing process should be worn while rinsing containers.
  2. The procedure for rinsing containers should begin immediately after emptying the contents into the application equipment. Allowing the residue to dry in the empty containers for even a few hours will reduce the effectiveness of the procedure. If the company can’t rinse them immediately, leave the caps on the containers until prepared to do so. This will help prevent the pesticide from drying inside the containers.
  3. Pour the pesticide into the application equipment where the spray mix is created and let the pesticide container drain for an additional 30 to 60 seconds. This step greatly enhances the ability to remove the residue during the triple rinsing process.
  4. Add clean water (or other diluent specified on the label) equal to 10 to 25 percent of the container’s volume and secure the cap.
  5. Shake or roll the container so that the interior surfaces will be rinsed.
  6. Pour the rinsate into the spray mix and allow the container to drain for an additional 30 seconds. This completes the first cycle.
  7. Repeat the procedures outlined in steps 4 to 6. This completes the second cycle.
  8. Again, repeat steps 4 to 6. If the rinsate still appears cloudy or milky, keep repeating until the water looks clear, indicating a thorough rinse. If the pesticide is an emulsifiable concentrate (EC) or a liquid flowable (LF), multiple rinses are always advisable.
  9. Render all plastic and metal containers unusable by puncturing or crushing.
  10. The final step is to dispose of the empty containers in a sanitary landfill or offer them for recycling.

Technically, if the steps above are done properly for each pesticide container, the rinsate should all be in the spray mix in the application equipment. However, if any rinsate is left over, dispose of it properly in accordance with the product labeling and federal and state laws and regulations.

When rinsing is not an option

Triple and pressure rinsing pesticide containers are not viable options in certain situations. Thorough removal of pesticide products packaged in bags and aerosol spray cans may be accomplished by taking the following steps:

Container typePesticide removal steps
Multi-layered bags
  1. Empty the contents of the bag into the tank.
  2. Shake the bag to remove as much product as possible.
  3. Cut the sides and folds to fully open the bag and add any remaining pesticide to the tank.
  4. Dispose of the cut and flattened bag in a sanitary landfill.
Aerosol spray cans
  1. Spray remaining contents on the proper site as directed by the label.
  2. Recycle or deposit the empty aerosol can in the sanitary landfill.
  • Note: Some state regulations consider the act of spraying the can to be a treatment method and/or may prohibit this. Check with the state.

Best practices

  • There are certain best practices for pesticide management such as reading and following all label instructions and never reusing pesticide containers.

Consider the following best practices:

  • Read and follow all label instructions. This includes directions for use, precautionary statements (hazards to humans, domestic animals, and endangered species), environmental hazards, rates of application, number of applications, reentry intervals, harvest restrictions, storage and disposal, and any specific warnings and/or precautions for safe handling of the pesticide.
  • Wear appropriate protective clothing and equipment when working with pesticides.
  • Rinse containers immediately after emptying because some pesticide residues will dry quickly and become difficult to remove. If the container cannot be rinsed immediately, replace the cap until it can be rinsed.
  • Never reuse pesticide containers (rinsed or unrinsed).
  • Contact the manufacturer, dealer, or business where pesticides were purchased to see if they will take back rinsed pesticide containers or unused concentrates.
  • Never allow empty pesticide containers to accumulate where unauthorized people have access to them. Such containers may be dangerous to children, pets, livestock, and wildlife, as well as adults who might convert them to other uses.
  • In the event of a pesticide spill, remove all persons from possible chemical exposure; control the spill; contain it by diking and absorbing liquid pesticides with dry material such as sawdust, kitty litter, or shredded paper; and report the spill.
  • Post medical/spill emergency telephone numbers in a prominent location.

The proper transportation and storage of pesticides and the proper rinsing and disposal of empty pesticide containers demonstrate that applicators are competent professionals who are concerned about the environment.

Worker Protection Standard (WPS)

  • The WPS requires agricultural employers and commercial pesticide handler employers to provide specific information and protections to workers and handlers when WPS-labeled pesticide products are used on agricultural establishments in the production of agricultural plants.

The Environmental Protection Agency (EPA) originally issued 40 CFR 170, the Worker Protection Standard (WPS), in 1992 and subsequently revised it in 2015. The regulation is primarily intended to reduce the risks of illness or injury to workers and handlers resulting from occupational exposures to pesticides used in the production of agricultural plants on agricultural establishments (i.e., farms, forests, nurseries, and enclosed space production facilities such as greenhouses).

Workers are generally those who perform hand-labor tasks in pesticide-treated crops, such as harvesting, thinning, and pruning. Handlers are usually those that are in direct contact with pesticides such as mixing, loading, or applying pesticides.

The 2015 revisions to the WPS strengthened elements of the existing regulation to better protect workers and handlers from occupational exposure to pesticides and reduce the number of potentially preventable pesticide incidents and illnesses. The 2015 revisions also ensured that workers and handlers receive workplace protections comparable to those that are already provided to workers in other industries while still considering the unique needs of agricultural operations.

The WPS requires agricultural employers and commercial pesticide handler employers to provide specific information and protections to workers, handlers, and other persons when WPS-labeled pesticide products are used on agricultural establishments in the production of agricultural plants. It also requires owners of agricultural establishments to provide certain protections for themselves and their immediate family, requires handlers to wear the labeling-specified clothing and personal protective equipment when performing handler activities, and to take measures to protect workers and other persons during pesticide applications.

Basic principles of the WPS

  • WPS is based on a foundation of three basic principles — inform, protect, and mitigate.
  • There are WPS requirements for each of the three principles.

The Worker Protection Standard (WPS) is based on a foundation of three basic principles to enhance protections provided to agricultural workers, pesticide handlers, and other persons. These principles are to inform, protect, and mitigate.

Inform

To ensure employees will be informed about exposure to pesticides, the WPS requires:

  • Pesticide safety training for workers and handlers.
  • Pesticide safety information that includes basic safety concepts (on a poster or otherwise displayed) available at the central location and some decontamination sites.
  • Centrally located pesticide application information and safety data sheets (SDSs) available in an area accessible to workers and handlers. This information must be kept for two years at the establishment and must be provided to the employee, medical personnel, or the employee’s designated representative upon request.
  • Notification of workers about treated areas through posting signs or providing oral notification to avoid inadvertent pesticide exposures.
  • Information exchange between commercial pesticide handler employers and agricultural employers.

Protect

To ensure employees will be protected from exposures to pesticides, the WPS requires employers to:

  • Exclude workers and others from areas being treated with pesticides.
  • Exclude workers and others from the application exclusion zone (AEZ) within the boundaries of the agricultural establishment during pesticide applications.
  • Exclude workers from areas that remain under a restricted-entry interval (REI), with narrow exceptions.
  • Ensure a pesticide handler or an early-entry worker (i.e., one that enters a treated site prior to the expiration of the REI) be a minimum of 18 years old.
  • Prohibit handlers from applying a pesticide in a way that will expose workers or other persons.
  • Protect handlers during handling tasks, including monitoring, while handling highly toxic pesticides.
  • Provide, maintain, and ensure the correct use of personal protective equipment (PPE) including enhanced protections for the use of respirators.
  • Protect early-entry workers who are doing permitted tasks in treated areas during an REI, including special instructions and duties related to correct use of PPE.

In addition, the WPS requires handlers to:

  • Apply pesticides in a way that will not expose workers or other persons.
  • Suspend applications if anyone, other than a trained and equipped handler involved with the application, is in the AEZ during a pesticide application (which may be outside the establishment’s property boundary).
  • Wear PPE specified on the pesticide product labeling.

Mitigate

To address pesticide exposures that employees may experience, the WPS requires employers to provide:

  • Decontamination supplies. Employers at agricultural establishments must provide workers and handlers with:
    • Enough water for routine washing and emergency eye flushing.
    • Enough soap and single use towels for workers’ or handlers’ needs.
  • For handlers, employers must also provide:
    • Enough water for washing the entire body in case of emergency.
    • A clean change of clothes, such as one-size-fits-all coveralls, to put on if the handlers’ garments are contaminated and need to be removed immediately.
  • Eyewash water for handlers using pesticides requiring protective eyewear.
  • Emergency assistance, such as making transportation available to a medical care facility if an agricultural worker or handler may have been poisoned or injured by a pesticide and providing information about the pesticide(s) to which the person may have been exposed.

Who does the WPS apply to?

  • There are various people the WPS applies to including a person who owns or operates an agricultural establishment directly related to the production of an agricultural plant.

The Worker Protection Standard (WPS) applies to an individual if:

  • The person owns or operates an agricultural establishment directly related to the production of an agricultural plant. Even if the person is the owner of a farm, forest, nursery, or an enclosed space production facility (e.g., greenhouse, grow house, hoop house, or high tunnel) and the individual or members of the individual’s “immediate” family do all the work, the person is a “WPS employer” and must comply with some of the requirements of WPS.
  • The person hires or contracts for the services of agricultural workers to do tasks related to the production of agricultural plants on an agricultural establishment. This includes hiring labor contractors and others who contract with growers to supply workers or handlers to work on the agricultural establishment. The labor contractor can be assigned WPS responsibilities but is not responsible for the individual’s WPS compliance.
  • The person employs researchers who help produce agricultural plants. There is an exemption from the WPS requirements when conducting research on unregistered pesticides. This exemption does not include research on unregistered uses of a registered pesticide product or maintenance pesticide applications applied to agricultural plants subject to research.
  • The person operates a business in which the person (or people employed) apply pesticides that are used for the production of an agricultural plant. Commercial pesticide handlers and their employees are included in the WPS even if some of the pesticide handling tasks (mixing, loading, disposal, etc.) take place somewhere other than the agricultural establishment that is the treatment site. An example would be mixing/loading at the commercial handling establishment or an airport hangar.
  • The person operates a business in which the person (or people employed) perform tasks as a crop advisor on any agricultural establishment. “Crop advisor” means any person who is assessing pest numbers or damage, pesticide distribution, or the status, condition, or requirements of agricultural plants.
  • The person is a pesticide handler who applies WPS-labeled pesticide products on an agricultural establishment. Handlers have several specific responsibilities under WPS separate from employers of handlers that deal with the actual application of the pesticide and wearing personal protective equipment (PPE).

Exemptions from the WPS

  • Owners and immediate family members are exempt from some WPS requirements.
  • Certified or licensed crop advisors are exempt from certain WPS provisions when performing crop advisor tasks.
  • Other limited and narrow circumstances that may occur when pesticides are applied on an agricultural establishment are exempt from the WPS.

Certain exemptions from the Worker Protection Standard (WPS) apply. Note that these categories are exempt from only certain provisions of WPS, not the entire standard.

Owners and immediate family members are exempt from some WPS requirements. Specifically, agricultural owners are not required to provide themselves or members of their immediate family with the following WPS protections:

  • The display of pesticide safety information at a central location.
  • Keeping records of pesticide applications and safety data sheets (SDSs).
  • Minimum age requirements for handlers and early-entry workers.
  • Pesticide safety training.
  • Decontamination supplies and emergency assistance.
  • Notice about pesticide applications.
  • Monitoring of handlers and specific handling instructions.
  • Equipment safety.
  • All the specific duties related to the care of personal protective equipment (PPE) and management of its use.
  • The following duties related to early entry:
    • Training and instructions,
    • Decontamination supplies, and
    • Specific duties related to the care of PPE and management of its use.

Note: These WPS protections must be provided to any workers or handlers who are NOT immediate family members.

Certified or licensed crop advisors are also exempt from certain WPS provisions when performing crop advisor tasks. The following exemptions apply:

  • Certified or licensed crop advisors are exempt from pesticide safety training as well as WPS pesticide handler training (if they have received equivalent information from their certification or license).
  • If certified or licensed crop advisors conduct only crop advising tasks (i.e., perform no other handler activities) during the restricted-entry interval, they may determine the appropriate PPE to wear rather than wearing the handler PPE required by the label.
  • The employer of the certified or licensed crop advisor does not have to provide decontamination supplies, emergency assistance, or access to the label.

Non-certified crop advisors (who are handlers under the WPS) may enter treated areas during the restricted-entry interval without time limitations if they wear the PPE required on the pesticide labeling and provide the other protections required for handlers, including decontamination supplies, emergency assistance, monitoring, and special instructions for handlers.

Employees of agricultural establishments who perform crop advisor tasks in a treated area within 30 days of the expiration of the restricted-entry interval must receive the same protections as workers under the WPS.

Other limited and narrow circumstances that may occur when pesticides are applied on an agricultural establishment are exempt from the WPS. These circumstances include:

  • Application for mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs that are sponsored by governmental entities (note, however, that the WPSdoes apply to cooperative programs in which the growers themselves make or arrange for pesticide applications).
  • When used on livestock (or other animals) or in or about animal premises.
  • On plants grown for other than commercial or research purposes (e.g., plants in habitations, home fruit and vegetable gardens, and home greenhouses).
  • On plants that are in ornamental gardens, parks, and public or private lawns and grounds that are intended only for aesthetic purposes or climatic modification.
  • Application by injection directly into agricultural plants. Note that direct injection does not include “hack and squirt,” “frill and spray,” chemigation, soil-incorporation, or soil-injection.
  • Applications conducted in a manner not directly related to the production of agricultural plants (e.g., structural pest control, control of vegetation along rights-of-way and in other non-crop areas, and pasture and rangeland use).
  • For control of vertebrate pests not related to production of the agricultural crop, and use as attractants or repellents in traps.
  • On the harvested portions of agricultural plants or on harvested timber.
  • For research uses of unregistered pesticides.

Pesticides covered by the WPS

  • A pesticide product is usually covered by the WPS if an “AGRICULTURAL USE REQUIREMENTS” statement is in the Directions for Use section on the product labeling.
  • If the pesticide labeling bears an “AGRICULTURAL USE REQUIREMENTS” section, but the product can also be applied to rights-of-way, the rights-of-way use is not covered by the WPS.

Most pesticide uses involved in the indoor or outdoor production of agricultural plants on an agricultural establishment are covered by the Worker Protection Standard (WPS). This includes pesticides used on plants and pesticides used on the soil or other planting medium the plants are (or will be) grown in. Both general-use and restricted-use pesticides are covered by the WPS. A pesticide product is usually covered by the WPS if an “AGRICULTURAL USE REQUIREMENTS” statement is in the Directions for Use section on the product labeling.

When a pesticide product with labeling that refers to the WPS is used on an agricultural establishment directly related to the production of an agricultural plant, this usage must be in compliance with WPS requirements. Although some protective requirements for workers and handlers (personal protective equipment, restricted-entry interval, etc.) are clearly identified on the pesticide product label, other WPS requirements are referred to through the statement on the label, “It is violation of federal law to use a pesticide product in a manner inconsistent with its labeling.”

Which pesticide uses are not covered by the WPS?

Some pesticide uses are not covered by the WPS, even when the “AGRICULTURAL USE REQUIREMENTS” section is on the labeling.

For example, if the pesticide labeling bears an “AGRICULTURAL USE REQUIREMENTS” section, but the product can also be applied to rights-of-way, the rights-of-way use is not covered by the WPS. The WPS does not apply when a pesticide product label requires compliance with the WPS and is applied on an agricultural establishment in the following circumstances:

  • As part of government-sponsored public pest control programs over which the owner, agricultural employer, and handler employer have no control (e.g., mosquito abatement or Mediterranean fruit fly eradication).
  • On plants other than agricultural plants, which may include plants in home fruit and vegetable gardens, home greenhouses, and permanent plantings for ornamental purposes (e.g., plants that are in ornamental gardens, parks, public or private landscaping, and lawns or other grounds that are intended only for aesthetic purposes or climatic modification).
  • For control of vertebrate pests such as rodents, unless directly related to the production of an agricultural plant.
  • As an attractant or repellent in traps.
  • On the harvested portions of agricultural plants or on harvested timber.
  • For research uses of unregistered pesticides.
  • On pasture or rangeland where the forage will not be harvested for hay or for any use.
  • In a manner not directly related to the production of agricultural plants, including, but not limited to, livestock pest control (e.g., pesticide applications on livestock or other animals, or in or about animal premises), structural pest control, and control of vegetation in non-crop areas.

WPS workers and handlers

  • A worker is anyone who is employed in exchange for a salary or wages and doing tasks directly related to the production of agricultural plants on an agricultural establishment.
  • A handler is anyone who is employed in exchange for a salary or wages or by an agricultural establishment or a commercial pesticide handling establishment that uses pesticides in the production of agricultural plants and is also doing certain tasks.

Under the Worker Protection Standard (WPS), a “worker” is anyone who is employed (including self-employed) in exchange for a salary or wages or other monetary compensation and doing tasks directly related to the production of agricultural plants on an agricultural establishment such as harvesting, weeding, carrying nursery stock, repotting plants, pruning, or watering.

Under the WPS, the definition of a “handler” is a bit more complex. A handler is anyone who is employed (including self-employed) in exchange for a salary or wages or other monetary compensation by an agricultural establishment or a commercial pesticide handling establishment that uses pesticides in the production of agricultural plants and is also doing any of the following tasks:

  • Mixing, loading, transferring, applying, or disposing of pesticides;
  • Handling opened containers of pesticides; emptying, triple-rinsing, or cleaning pesticide containers according to pesticide product labeling instructions; or disposing of pesticide containers that have not been cleaned;
  • Acting as a flagger;
  • Cleaning, adjusting, handling, or repairing the parts of mixing, loading, or application equipment that may contain pesticide residues;
  • Assisting with the application of pesticides, including incorporating the pesticide into the soil after the application has occurred, or dipping plant cuttings in rooting hormones that are registered pesticides;
  • Entering a greenhouse or other enclosed space after application and before the inhalation exposure level listed on the pesticide product labeling has been reached or any ventilation criteria established by the WPS or on the pesticide product labeling has been met to:
    • Operate ventilation equipment,
    • Adjust or remove coverings, such as tarps used in fumigation, or
    • Check air pesticide concentration levels;
  • Entering a treated area outdoors after application of any soil fumigant to adjust or remove soil coverings, such as tarps; or
  • Performing tasks as a crop advisor:
    • During any pesticide application,
    • During any restricted-entry interval, or
    • Before any inhalation exposure level listed on the pesticide product labeling has been reached or any ventilation criteria established by the WPS or on the pesticide product labeling has been met.

For example: The individual is a handler if that individual is loading unopened water-soluble packets into a mixing tank (because the person is mixing and loading the pesticide). An individual is not a handler if that individual:

  • Purchases pesticides and transports them unopened to an establishment.
  • Carries containers that have never been opened into a pesticide storage facility.
  • Transports containers that have never been opened to the site where they are to be mixed, loaded, or applied.

Handlers who are currently certified as applicators of restricted-use pesticides must be given all the WPS handler protections (except they do not need to receive WPS training).

Requirements for handlers and employers of handlers

  • The handler employer and the handler must ensure that no pesticide is applied to contact, directly or through drift, any worker or other person, other than an appropriately trained and equipped handler involved in the application.
  • If a pesticide product with the skull-and-crossbones symbol is being used, a handler employer must ensure that the handler is monitored visually or by voice communication at least every two hours.

Agricultural employers must comply with certain requirements during pesticide applications to protect workers and other persons, such as bystanders, and those who employ handlers (i.e., handler employers) and the handlers themselves must comply with these requirements.

Do not let pesticides contact workers or any persons. The handler employer and the handler must ensure that no pesticide is applied so as to contact, directly or through drift, any worker or other person, other than an appropriately trained and equipped handler involved in the application. This is a requirement for both handlers and handler employers, and it is also a labeling requirement with which the pesticide applicator must comply.

Suspend pesticide applications in certain situations. A handler making a pesticide application must temporarily suspend the application if any worker or other person (other than an appropriately trained and equipped handler involved with the application) is in the:

  • Application exclusion zone (AEZ) for outdoor production applications, or
  • Area required to be free of workers or others during enclosed space production application.

The handler requirement to suspend the application applies if a worker or other person is in any portion of the AEZ. In this situation, the applicator must temporarily suspend the application and may not proceed until the applicator can ensure that the pesticide will not contact any persons that are in the AEZ, including areas that extend beyond the boundary of the establishment. An agricultural employer may not allow a pesticide to be applied, or a suspended application to be resumed, while any worker or other person on the establishment is in the treated area or within the AEZ.

Monitor handlers. If a pesticide product that has the skull-and-crossbones symbol on the front panel of the pesticide product label is being used, a handler employer must ensure that the handler is monitored visually or by voice communication at least every two hours.

Communicate continuously with handlers. When a handler is using a fumigant pesticide product in an enclosed space production area, a handler employer must ensure that the handler maintains continuous visual or voice contact with another handler stationed immediately outside of the enclosed space. The handler stationed outside of the enclosed space must have immediate access to and be able to use the personal protective equipment (PPE) required by the fumigant product labeling for applicators in case there is a need to assist or rescue the handler making the application.

Pesticide safety, application, and hazard information

  • Pesticide safety information must be conveyed in a manner that workers and handlers can understand.
  • The agricultural employer must update the pesticide safety information display within 24 hours of notice of any changes to the information.
  • Pesticide application and hazard information for any pesticides used at an agricultural establishment must be displayed and made accessible to employees.

Under the Worker Protection Standard (WPS), agricultural employers must display certain information at a central location whenever any worker or handler they employ is on their agricultural establishment and, within the past 30 days, a WPS-labeled pesticide product has been applied or a restricted-entry interval (REI) for the pesticide has been in effect. The requirement to display information is not applicable to commercial pesticide handler employers.

Pesticide safety information

Pesticide safety information must be conveyed in a manner that workers and handlers can understand. All of these points may be on one poster that conveys the required information, and the Environmental Protection Agency (EPA) provides posters that comply with this requirement in numerous languages on the agency’s Pesticide Worker Safety website under the heading “Worker Protection Standard Materials”.

As of January 2, 2018, the pesticide safety information must include all of the points listed below:

  • Avoid getting on the skin or into the body any pesticides that may be on or in plants, soil, irrigation water, tractors, and other equipment, on used personal protective equipment (PPE), or drifting from nearby applications.
  • Wash before eating, drinking, using chewing gum or tobacco, or using the toilet.
  • Wear work clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and socks, and a hat or scarf).
  • Wash or shower with soap and water, shampoo hair, and put on clean clothes after work.
  • Wash work clothes separately from other clothes before wearing them again.
  • If pesticides are spilled or sprayed on the body, use decontamination supplies to wash immediately or rinse off in the nearest clean water, including springs, streams, lakes or other sources if more readily available than decontamination supplies, and as soon as possible, wash or shower with soap and water, shampoo hair, and change into clean clothes.
  • Follow directions about keeping out of treated areas and application exclusion zones (AEZs).
  • Instructions to employees to seek medical attention as soon as possible if they believe they have been poisoned, injured, or made ill by pesticides.
  • The name, address, and telephone number of a nearby operating medical care facility capable of providing emergency medical treatment. This information must be clearly identified as emergency medical contact information on the display.
  • The name, address, and telephone number of the state or tribal pesticide regulatory agency.

The agricultural employer must update the pesticide safety information display (i.e., contact information for medical care facility and regulatory agency) within 24 hours of notice of any changes to this information.

Pesticide application and hazard information

Pesticide application and hazard information for any pesticides used at an agricultural establishment must be displayed and made accessible to employees. The following information must be included:

  • Hazard information in the form of a copy of the Occupational Health and Safety Administration (OSHA) safety data sheet (SDS) for each pesticide product.
  • Pesticide application information, including:
    • Name of the pesticide applied,
    • Active ingredient(s),
    • Environmental Protection Agency (EPA) registration number,
    • Restricted-entry interval (REI),
    • Crop or site treated,
    • Location and description of the treated area(s), and
    • Date(s) and times application started and ended.

Where must the information be displayed?

Pesticide safety, application, and hazard information must be displayed at a central location on an agricultural establishment that is always readily accessible during normal work hours and can be easily seen and read by workers and handlers. Usually, this is a location where employees congregate such as where they check in or out of work, change clothes, or eat. In addition, pesticide safety information must be displayed at:

  • Any permanent decontamination site, and
  • Any location where decontamination supplies are required in quantities for 11 or more workers.

Other employer responsibilities include:

  • Inform workers and handlers where the pesticide safety, application, and hazard information is located.
  • Allow workers and handlers unrestricted access to the posted information.
  • Ensure the pesticide safety information and pesticide application information remains legible the entire time they are posted.
  • Update the emergency medical facility information listed with the poster within 24 hours of obtaining new information.

Pesticide safety information must be conveyed in a manner that workers and handlers can understand. All of these points may be on one poster or any alternate display format that conveys the required information.

Notification of worker entry restrictions

  • Establishments must notify workers of all entry restrictions associated with pesticide applications if directed to do so by the pesticide product labeling.

The following requirements apply to agricultural employers who employ workers. Details are found in the regulation at 40 CFR 170.409.

Notice about applications

  1. Orally warn workers and post treated areas if required by the pesticide labeling.
  2. If not, post warning signs if the restricted-entry interval (REI) is greater than:
    • 48 hours for outdoor production, or
    • 4 hours for enclosed space production.
  3. For all other applications, either orally warn workers or post warning signs.

Posted warning signs

  1. Post legible 14-inch by 16-inch WPS-design warning signs no more than 24 hours prior to an application. Keep posted during REI. Remove or cover before workers enter and within 3 days after the end of the REI.
  2. Post signs so they can be seen at all reasonably expected entrances to treated areas.
  3. Warning signs can be smaller than 14 inches by 16 inches under certain conditions. All warning signs must meet specific requirements.

Regulations state the warning sign must use letters at least one inch in height on a white background. The words “DANGER” and “PELIGRO,” plus “PESTICIDES” and “PESTICIDAS,” must be at the top of the sign, and the words “KEEP OUT” and “NO ENTRE” must be at the bottom of the sign. Letters for all words must be clearly legible. Other graphical elements are required. Below is a compliant example of signage from the regulation.

Oral warnings

  1. Before each application, tell workers who are on the establishment (in a manner they can understand):
    • Location and description of treated area,
    • Date and times entry is restricted
    • Exclusion zone, REI, and not to enter during REI.
  2. Workers who enter the establishment after application starts must receive the same warning at the start of their work period.

Records and emergency assistance

  • Pesticide records must be maintained for any covered use of a WPS-labeled pesticide for either general-use or restricted-use pesticides.

Pesticide records must be maintained for any covered use of a Worker Protection Standard (WPS)-labeled pesticide for either general-use or restricted-use pesticides (even if state or tribal laws do not require pesticide recordkeeping).

Pesticide records must contain:

  • Name of the pesticide applied,
  • Active ingredient,
  • Environmental Protection Agency (EPA) registration number,
  • Restricted-entry interval (REI),
  • Crop or site treated,
  • Location and description of the treated area(s),
  • Date(s) and times application started and ended, and
  • Safety data sheet (SDS) of the pesticide applied.

Emergency assistance

The agricultural employer must provide transportation and emergency information promptly for their workers after learning of possible poisoning or injury if:

  • There is reason to believe that a worker or handler experienced a potential pesticide exposure during the worker’s or handler’s employment on their employer’s agricultural establishment, or
  • An employee shows symptoms similar to those associated with acute exposure to pesticides during or within 72 hours after the employee’s employment on the agricultural establishment and needs emergency medical treatment.

Provide all the following information to the treating medical personnel:

  • Copies of the applicable SDS, the pesticide product name, EPA registration number, and active ingredient(s) for each pesticide product to which the person may have been exposed.
  • Type of application or how the pesticide was used on the agricultural establishment.
  • The circumstances that could have resulted in exposure to the pesticide.

Training requirements

  • Employees must receive WPS training before they perform any worker or handler task on the establishment and once every 12 months.
  • Training records for each worker and handler must be kept on the establishment for two years from the date of training.
  • Handlers must receive training every 12 months.

All workers and handlers employed by an agricultural employer must receive annual Worker Protection Standard (WPS) training as a worker or as a handler (except as provided for in exemptions or exceptions). Employees must receive WPS training before they perform any worker or handler task on the establishment.

Workers must be trained once every 12 months (i.e., annually), counting from the end of the month in which the previous training was completed. Note that only qualified trainers may provide WPS training.

The following are key requirements for training workers and handlers:

  • The agricultural employer must ensure that WPS training is completed within the last 12 months before:
    • Any worker enters a treated area on an agricultural establishment where, within the last 30 days, a WPS-labeled pesticide product has been used or a restricted-entry interval (REI) for such pesticide has been in effect.
    • Any handler conducts any handling task.
  • Workers and handlers are exempt from WPS training if they are currently:
    • Certified as an applicator of restricted-use pesticides;
    • Certified as a crop advisor by a program acknowledged as appropriate in writing by the Environmental Protection Agency (EPA) or a state or tribal agency responsible for pesticide enforcement.
  • Additionally, a worker is exempt from WPS worker training if they have been trained as a WPS handler within the last 12 months.
  • Provide training in a manner that the workers or handlers can understand, using a translator if necessary.
  • Present training using EPA-approved materials either orally from written materials or audio-visually.
  • Keep records of worker or handler training for two years.
  • Make training records available to employees upon request.

Training records

Training records for each worker and handler must be kept on the establishment for two years from the date of training. The training record must include:

  • The worker’s or handler’s printed name and signature,
  • The date of training,
  • Trainer’s name,
  • Evidence of the trainer’s qualification to train,
  • Employer’s name, and
  • Information to identify which EPA-approved training materials (at https://www.epa.gov/pesticide-worker-safety) were used for the training (i.e., the EPA document number or EPA approval number for the materials).

WPS trainers are not required to provide each person trained with a copy of the training record. However, they must provide the record if the trained employee requests it. Individual training record forms or other methods of maintaining the required training information may be developed and used to meet this requirement.

Training pesticide handlers

Before any handler performs any handler task, the handler employer must ensure that each handler has completed WPS training within the last 12 months, unless the handler is currently:

  • Certified as an applicator of restricted-use pesticides, or
  • Certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or the state or tribal agency responsible for pesticide enforcement.

Train handlers every 12 months. In addition:

  • Only qualified trainers may provide training and must be present during the entire training program to respond to questions.
  • Provide training in a language or manner the handlers can understand, using a translator if necessary.
  • Present training using EPA-approved materials (at https://www.epa.gov/pesticide-worker-safety) either orally from written materials or audiovisually.
  • Keep training records for two years.
  • Provide training records to handler employees upon request.

Trainer qualifications and conducting training

  • Trainers must be a certified applicator; designated as a trainer by EPA, a state agency, or a tribal agency; or have completed an EPA-approved train-the-trainer program.

Trainer qualifications

The person who conducts worker or handler training under the Worker Protection Standard (WPS) must:

  • Currently be a certified applicator of restricted-use pesticides (in any category of certification), or
  • Currently be designated as a trainer of certified pesticide applicators, handlers, or workers by the Environmental Protection Agency (EPA) or the state or tribal agency having jurisdiction, or
  • Have completed an EPA-approved pesticide safety train-the-trainer program for trainers of workers.

Conducting training

Trainers of workers or handlers must:

  • Use EPA-approved training materials (learn more at www.epa.gov/pesticide-worker-safety);
  • Present the training orally from written materials or audiovisually;
  • Present the information in a manner that the trainees can understand, using a translator if necessary;
  • Be present at all times during the training to respond to trainees’ questions; and
  • Ensure training quality by providing an environment conducive to training that is reasonably free of distractions.

For handlers, labeling information as well as application-specific information and training on pesticide application equipment must be provided. The handler must either read or be informed of all sections of the pesticide product labeling applicable to the safe use of the pesticide, including label use directions and restrictions. The handler must be given this information in a manner they can understand, and the labeling must be available to the handler at all times during handler activities.

Handlers must be made aware of any entry restrictions, application exclusion zones (AEZs), and restricted-entry intervals (REIs) that may apply to the activities being performed by the handler.

A handler employer must also ensure that:

  • Handlers are instructed in the safe operation of equipment used to mix, load, transfer, or apply pesticides before they use the equipment.
  • Each day before using any equipment to mix, load, transfer or apply pesticides, the equipment is inspected for leaks, clogged nozzles, and worn or damaged parts, and the equipment is repaired or replaced before it is used.

Restricted use pesticides (RUPs)

  • RUPs may only be bought and used by certified pesticide applicators, and these workers must complete required training, testing, and continuing education.

Restricted use pesticides (RUPs) are not available for purchase or use by the general public, and they have the potential to cause unreasonable adverse effects to the environment and injury to applicators or bystanders without added restrictions. The “restricted use” classification restricts a product (or its various uses) to use by a certified applicator or someone under the certified applicator’s direct supervision.

RUPs may only be bought and used by certified pesticide applicators, and these workers must complete required training, testing, and continuing education. EPA maintains an updated list of RUPs on the agency’s website, and these substances are regulated under 40 CFR 171.

Requirements under RUP regulations include:

  • Commercial and private applicators of RUPS must comply with certification and recertification requirements for each pesticide category in which they wish to be certified.
  • Certified applicators must be tested and recertified every five years.
  • Certified applicators must be at least 18 years of age.
  • Certified applicators must supervise noncertified applicators.
  • Certified applicators must ensure noncertified applicators are trained and meet the minimum age requirements.

Certification categories for RUP applicators

  • Applicators of RUPs must be recertified every five years.
  • There are various categories of commercial applicators using or supervising the use of RUPs that require certification.

Several categories of commercial applicators using or supervising the use of restricted use pesticides (RUPs) that require certification are outlined here.

  • Agricultural pest control (crop pest control) — This category applies to commercial applicators who use or supervise the use of RUPs in production of agricultural commodities, including, but not limited to, grains, vegetables, small fruits, tree fruits, peanuts, tree nuts, tobacco, cotton, and feed and forage crops, including grasslands, and non-crop agricultural lands.
  • Agricultural pest control (livestock pest control) — This category applies to commercial applicators who use or supervise the use of RUPs on animals or to places on or in which animals are confined. Certification in this category alone is not sufficient to authorize the purchase, use, or supervision of use of products for predator control.
  • Forest pest control — This category applies to commercial applicators who use or supervise the use of RUPs in forests, forest nurseries, and forest seed production.
  • Ornamental and turf pest control — This category applies to commercial applicators who use or supervise the use of RUPs to control pests in the maintenance and production of ornamental plants and turf.
  • Seed treatment — This category applies to commercial applicators using or supervising the use of RUPs on seeds in seed treatment facilities.
  • Aquatic pest control — This category applies to commercial applicators who use or supervise the use of any RUP purposefully applied to standing or running water, excluding applicators engaged in public-health-related activities.
  • Right-of-way pest control — This category applies to commercial applicators who use or supervise the use of RUPs in the maintenance of roadsides, powerlines, pipelines, railway rights-of-way, and similar areas.
  • Industrial, institutional, and structural pest control — This category applies to commercial applicators who use or supervise the use of RUPs in, on, or around the following: food handling establishments, packing houses, and food-processing facilities; human dwellings; institutions, such as schools, hospitals, and prisons; and industrial establishments, including manufacturing facilities, warehouses, grain elevators, and any other structures and adjacent areas, public or private, for the protection of stored, processed, or manufactured products.
  • Public health pest control — This category applies to state, tribal, federal, or other governmental employees and contractors who use or supervise the use of RUPs in government-sponsored public health programs for the management and control of pests having medical and public health importance.
  • Regulatory pest control — This category applies to state, tribal, federal, or other local governmental employees and contractors who use or supervise the use of RUPs in government-sponsored programs for the control of regulated pests. Certification in this category does not authorize the purchase, use, or supervision of use of products for predator control listed below (i.e., sodium cyanide and sodium fluoroacetate).
  • Demonstration and research — This category applies to individuals who demonstrate to the public the proper use and techniques of application of RUPs or supervise such demonstration, and to persons conducting field research with RUPs who, in doing so, use or supervise the use of RUPs. This includes such individuals as extension specialists and county agents; commercial representatives demonstrating RUP products; individuals demonstrating application or pest control methods used in public or private programs; and state, federal, commercial, and other persons conducting field research on or involving RUPs.
  • Sodium cyanide predator control — This category applies to commercial applicators who use or supervise the use of sodium cyanide in a mechanical ejection device to control regulated predators.
  • Sodium fluoroacetate predator control — This category applies to commercial applicators who use or supervise the use of sodium fluoroacetate in a protective collar to control regulated predators.
  • Soil fumigation — This category applies to commercial applicators who use or supervise the use of an RUP to fumigate soil.
  • Non-soil fumigation — This category applies to commercial applicators who use or supervise the use of an RUP to fumigate anything other than soil.
  • Aerial pest control — This category applies to commercial applicators who use or supervise the use of RUPs applied by fixed or rotary wing aircraft.

Note: Applicators of RUPs must be recertified every five years. To be recertified, the applicator must pass a written exam or may be eligible for recertification by enrolling in approved continuing education programs

Commercial applicator competency and certification

  • To be certified, an applicator must be 18 years old and show competency in the core standards.
  • An applicator must show familiarity with pesticide labels and labeling and their functions and take measures to avoid or minimize adverse health effects.
  • Applicators must demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of RUPs for each category in which they wish to be certified.

To demonstrate competency in the use and handling of restricted use pesticides (RUPs), a commercial applicator must pass a written examination that meets the federal standards and any related performance tests required by the state. The exam must include the core standards and the standards applicable to each category in which an applicator wants to be certified.

To be certified, an applicator must be 18 years old and show competency in the core standards, which are listed below. In addition to the general core competencies, applicators also must demonstrate practical knowledge of the principles and practices of pest control and proper and effective use of RUPs for each category in which they wish to be certified.

Label and labeling comprehension — Familiarity with pesticide labels and labeling and their functions, including all the following:

  • The general format and terminology of pesticide labels and labeling.
  • Understanding instructions, warnings, terms, symbols, and other information commonly appearing on pesticide labels and labeling.
  • Understanding that it is a violation of federal law to use any registered pesticide in a manner inconsistent with its labeling.
  • Understanding labeling requirements that a certified applicator must be physically present at the site of the application.
  • Understanding labeling requirements for supervising noncertified applicators working under the direct supervision of a certified applicator.
  • Understanding that applicators must comply with all use restrictions and directions for use contained in pesticide labels and labeling, including being certified in the certification category appropriate to the type and site of the application.
  • Understanding the meaning of product classification as either general or restricted use and that a product may be unclassified.
  • Understanding and complying with product-specific notification requirements.
  • Recognizing and understanding the difference between mandatory and advisory labeling language.

Safety — Measures to avoid or minimize adverse health effects, including all of the following:

  • Understanding the different natures of the risks of acute toxicity and chronic toxicity, as well as the long-term effects of pesticides.
  • Understanding that a pesticide’s risk is a function of exposure and the pesticide’s toxicity.
  • Recognizing likely ways in which dermal, inhalation, and oral exposure may occur.
  • Common types and causes of pesticide mishaps.
  • Precautions to prevent injury to applicators and other individuals in or near treated areas.
  • The need for, and proper use of, protective clothing and personal protective equipment (PPE).
  • Symptoms of pesticide poisoning.
  • First aid and other procedures to be followed in case of a pesticide mishap.
  • Proper identification, storage, transport, handling, mixing procedures, and disposal methods for pesticides and used pesticide containers, including precautions to be taken to prevent children from having access to pesticides and pesticide containers.

Environment — The potential environmental consequences of the use and misuse of pesticides, including the influence of all of the following:

  • Weather and other indoor and outdoor climatic conditions.
  • Types of terrain, soil, or other substrate.
  • Presence of fish, wildlife, and other non-target organisms.
  • Drainage patterns.

Pests — The proper identification and effective control of pests, including all of the following:

  • The importance of correctly identifying target pests and selecting the proper pesticide product(s) for effective pest control.
  • Verifying that the labeling does not prohibit the use of the product to control the target pest(s).

Pesticides — Characteristics of pesticides, including all of the following:

  • Types of pesticides.
  • Types of formulations.
  • Compatibility, synergism, persistence, and animal and plant toxicity of the formulations.
  • Hazards and residues associated with use.
  • Factors that influence effectiveness or lead to problems such as pesticide resistance.
  • Dilution procedures.

Equipment — Application equipment, including all of the following:

  • Types of equipment and advantages and limitations of each type.
  • Use, maintenance, and calibration procedures.

Application methods — Selecting appropriate application methods, including all of the following:

  • Methods used to apply various forms and formulations of pesticides.
  • Knowledge of which application method to use in a given situation and that use of a fumigant, aerial application, sodium cyanide, or sodium fluoroacetate requires additional certification.
  • How selection of application method and use of a pesticide may result in proper use, unnecessary or ineffective use, and misuse.
  • Prevention of drift and pesticide loss into the environment.

Laws and regulations — Knowledge of all applicable state, tribal, and federal laws and regulations.

Responsibilities of supervisors of noncertified applicators — Knowledge of the responsibilities of certified applicators supervising noncertified applicators, including all of the following:

  • Understanding and complying with requirements in 40 CFR 171.201 for certified commercial applicators who supervise noncertified applicators using RUPs.
  • The recordkeeping requirements of pesticide safety training for noncertified applicators who use RUPs under the direct supervision of a certified applicator.
  • Providing use-specific instructions to noncertified applicators using RUPs under the direct supervision of a certified applicator.
  • Explaining pertinent state, tribal, and federal laws and regulations to noncertified applicators who use RUPs under the direct supervision of a certified applicator.

Professionalism — Understanding the importance of all of the following:

  • Maintaining chemical security for RUPs.
  • How to communicate information about pesticide exposures and risks with customers and the public.
  • Appropriate product stewardship for certified applicators.

Private applicator certification

  • A private applicator must be at least 18 years old and demonstrate competency in the use of pesticides.
  • Persons seeking certification as private applicators must demonstrate practical knowledge of the principles and practices of pest control associated with the production of agricultural commodities and effective use of RUPs.

A private applicator must be at least 18 years old and demonstrate competency in the use of pesticides. Before using or supervising the use of a restricted use pesticide (RUP) as a private applicator, a person must be certified by an appropriate certifying authority as having the necessary competency to use RUPs for pest control in the production of agricultural commodities, which includes the ability to read and understand pesticide labeling.

Persons seeking certification as private applicators must demonstrate practical knowledge of the principles and practices of pest control associated with the production of agricultural commodities and effective use of RUPs, including all of the following:

Label and labeling comprehension — Familiarity with pesticide labels and labeling and their functions, including all of the following:

  • The general format and terminology of pesticide labels and labeling.
  • Understanding instructions, warnings, terms, symbols, and other information commonly appearing on pesticide labels and labeling.
  • Understanding that it is a violation of federal law to use any registered pesticide in a manner inconsistent with its labeling.
  • Understanding when a certified applicator must be physically present at the site of the application, based on labeling requirements.
  • Understanding labeling requirements for supervising noncertified applicators working under the direct supervision of a certified applicator.
  • Understanding that applicators must comply with all use restrictions and directions for use contained in pesticide labels and labeling, including being certified in the appropriate category to use RUPs for fumigation or aerial application, or predator control devices containing sodium cyanide or sodium fluoroacetate, if applicable.
  • Understanding the meaning of product classification as either general or restricted use, and that a product may be unclassified.
  • Understanding and complying with product-specific notification requirements.
  • Recognizing and understanding the difference between mandatory and advisory labeling language.

Safety — Measures to avoid or minimize adverse health effects, including all of the following:

  • Understanding the different natures of the risks of acute toxicity and chronic toxicity, as well as the long-term effects of pesticides.
  • Understanding that a pesticide’s risk is a function of exposure and the pesticide’s toxicity.
  • Recognition of likely ways in which dermal, inhalation, and oral exposure may occur.
  • Common types and causes of pesticide mishaps.
  • Precautions to prevent injury to applicators and other individuals in or near treated areas.
  • Need for, and proper use of, protective clothing and personal protective equipment.
  • Symptoms of pesticide poisoning.
  • First aid and other procedures to be followed in case of a pesticide mishap.
  • Proper identification, storage, transport, handling, mixing procedures, and disposal methods for pesticides and used pesticide containers, including precautions to be taken to prevent children from having access to pesticides and pesticide containers.

Environment — The potential environmental consequences of the use and misuse of pesticides, including the influence of the following:

  • Weather and other climatic conditions.
  • Types of terrain, soil, or other substrate.
  • Presence of fish, wildlife, and other non-target organisms.
  • Drainage patterns.

Pests — The proper identification and effective control of pests, including all of the following:

  • The importance of correctly identifying target pests and selecting the proper pesticide product(s).
  • Verifying that the labeling does not prohibit the use of the product to control the target pest(s).

Pesticides — Characteristics of pesticides, including all of the following:

  • Types of pesticides.
  • Types of formulations.
  • Compatibility, synergism, persistence, and animal and plant toxicity of the formulations.
  • Hazards and residues associated with use.
  • Factors that influence effectiveness or lead to problems such as pesticide resistance.
  • Dilution procedures.

Equipment — Application equipment, including all of the following:

  • Types of equipment and advantages and limitations of each type.
  • Uses, maintenance, and calibration procedures.

Application methods — Selecting appropriate application methods, including all of the following:

  • Methods used to apply various forms and formulations of pesticides.
  • Knowledge of which application method to use in a given situation and that use of a fumigant, aerial application, or predator control device containing sodium cyanide or sodium fluoroacetate requires additional certification.
  • How selection of application method and use of a pesticide may result in proper use, unnecessary or ineffective use, and misuse.
  • Prevention of drift and pesticide loss into the environment.

Laws and regulations — Knowledge of all applicable state, tribal, and federal laws and regulations, including understanding the Worker Protection Standard (WPS) at 40 CFR 170 and the circumstances where compliance is required.

Responsibilities for supervisors of noncertified applicators — Certified applicator responsibilities related to supervision of noncertified applicators, including all of the following:

  • Understanding and complying with requirements at 40 CFR 171.201 for private applicators who supervise noncertified applicators using RUPs.
  • Providing use-specific instructions to noncertified applicators using RUPs under the direct supervision of a certified applicator.
  • Explaining appropriate state, tribal, and federal laws and regulations to noncertified applicators working under the direct supervision of a certified applicator.

Stewardship — Understanding the importance of all of the following:

  • Maintaining chemical security for RUPs.
  • How to communicate information about pesticide exposures and risks with agricultural workers and handlers and other persons.

Private applicators must also follow strict rules for fumigation and other application-specific safety measures.

Using noncertified applicators

  • A noncertified applicator must have been instructed within the last 12 months in the safe operation of any equipment the applicator will use for mixing, loading, transferring, or applying pesticides.
  • Before use of an RUP, the certified applicator must provide to each noncertified applicator instructions specific to the site and pesticide used.

In order to be able to use a noncertified applicator to apply restricted use pesticides (RUPs) under the certified applicator’s direct supervision, the certified applicator must have practical knowledge of the applicable federal, state, or tribal laws and must be certified in the particular pesticide category of supervised pesticide use.

The noncertified applicator must have been instructed within the last 12 months in the safe operation of any equipment the applicator will use for mixing, loading, transferring, or applying pesticides.

The noncertified applicator must be at least 18 years old; however, the noncertified applicator may be at least 16 years old if the following requirements are met:

  • The noncertified applicator is using the RUP under the direct supervision of a private applicator who is an immediate family member.
  • The RUP is not a fumigant, sodium cyanide, or sodium fluoroacetate.
  • The noncertified applicator is not applying the RUP aerially.

Additionally, the certified applicator must ensure that the noncertified applicator always has access to the applicable product labeling during its use.

Where the labeling of a pesticide product requires that personal protective equipment (PPE) be worn for mixing, loading, application, or any other use activities, the certified applicator must ensure that any noncertified applicator has clean PPE in proper operating condition and that the PPE is worn and used correctly for its intended purpose.

Before use of an RUP, the certified applicator must provide to each noncertified applicator instructions specific to the site and pesticide used. These instructions must include:

  • Labeling directions, precautions, and requirements applicable to the specific use and site; and
  • How the characteristics of the use site (e.g., surface and groundwater, endangered species, and local population) and the conditions of application (e.g., equipment, method of application, and formulation) might increase or decrease the risk of adverse effects.

The certified applicator must:

  • Provide this information in a manner that the noncertified applicator can understand.
  • Ensure that, before each day of use, equipment used for mixing, loading, transferring, or applying pesticides is in proper operating condition as intended by the manufacturer and can be used without risk of reasonably foreseeable adverse effects to the noncertified applicator, other persons, or the environment.
  • Ensure that a means to immediately communicate with the certified applicator is available to each noncertified applicator using RUPs under the applicator’s direct supervision.
  • Be physically present at the site of the use being supervised when required by the product labeling.

Training and recordkeeping

  • General noncertified applicator training must be given to noncertified applicators either orally from written materials or audiovisually.
  • The person conducting the training must be currently certified as an applicator of RUPs under 40 CFR 171.

General noncertified applicator training must be given to noncertified applicators either orally from written materials or audiovisually. The information must be presented in a manner that the noncertified applicators can understand, through a translator if necessary. The person conducting the training must be present during the entire training program and must respond to the noncertified applicators’ questions.

Trainer qualifications

The person conducting the training must meet one of the following criteria:

  • Be currently certified as an applicator of restricted use pesticides (RUPs) under 40 CFR 171;
  • Be currently designated as a trainer of certified applicators or pesticide handlers by the Environmental Protection Agency (EPA), the certifying authority, or a state, tribal, or federal agency having jurisdiction; or
  • Have completed an EPA-approved pesticide safety train-the-trainer program for trainers of handlers under 40 CFR 170.

Recordkeeping

Commercial applicators must create or verify the existence of records documenting that each noncertified applicator has the required minimum age and training qualifications. For each noncertified applicator, the records must contain the information appropriate to the method of qualification.

If the noncertified applicator was trained in accordance with requirements, the record must contain all of the following information:

  • The noncertified applicator’s printed name and signature,
  • The date the training requirement was met,
  • The name of the person who provided the training, and
  • The title or a description of the training provided.

Pesticide incidents

  • A pesticide incident is any exposure or effect from a pesticide’s use that is not expected or intended.
  • EPA stresses the importance of reporting incidents.

A pesticide incident is defined by the Environmental Protection Agency (EPA) as any exposure or effect from a pesticide’s use that is not expected or intended. These incidents have the potential to involve or affect humans, wildlife, pets, plants, and pollinators such as bees. Common causes and types of incidents include:

  • Pesticide spills;
  • Failure to follow pesticide label instructions regarding application or safety;
  • Applying pesticides in breezy conditions, which may cause drift;
  • Not wearing recommended or required personal protective equipment (PPE);
  • Equipment malfunctions;
  • Pesticide overuse;
  • Leaking or unsecured pesticide storage; and
  • Improper disposal of pesticides.

EPA stresses the importance of reporting incidents. The agency uses information reported to a variety of sources, including:

  • The National Pesticide Information Center (NPIC), a program that currently operates under a cooperative agreement between EPA and Oregon State University.
  • The Sentinel Event Notification System for Occupational Risk (SENSOR), which is administered by the National Institute for Occupational Safety and Health (NIOSH) and is the only existing aggregated pesticide surveillance program. The SENSOR-Pesticide program is critical for identifying existing and emerging pesticide issues.
  • Manufacturers (also called registrants) of pesticide products that are required to report adverse effects of their pesticides to EPA.
  • The American Association of Poison Control Centers.
  • EPA itself (some Information is submitted directly to the agency, including voluntary reporting by members of the public).

To report spills or misuse of pesticides, contact the state’s appropriate environmental regulatory agency, as regulation varies at the local level, and states generally have primary enforcement responsibility for pesticide misuse violations and for investigating possible instances of pesticide misuse.

If a person suspects that federal pesticide regulations have been violated, that person should submit a report to EPA on the agency’s website. For incidents that may not involve violations of pesticide laws and regulations, reports should be submitted to EPA via email at Report.Pesticide.Incident@epa.gov.

Pesticide drift

  • Pesticide spray drift is the movement of pesticide dust or droplets through the air, either at the time of application or soon afterward, to any site other than the area intended to be treated.
  • Pesticide drift can also result in economic loss and can pose health and environmental risks when sprays and dusts are carried by the wind and deposited on other areas.
  • In the case of pesticide drift, contact the NPIC or the state pesticide regulatory agency to report pesticide drift incidents.

Pesticide spray drift is the movement of pesticide dust or droplets through the air, either at the time of application or soon afterward, to any site other than the area intended to be treated. Pesticide droplets are produced by spray nozzles used in application equipment for spraying pesticides on crops, forests, turf, and home gardens (including aerial applications), while other pesticides take the form of very fine dry particles commonly referred to as dust formulations. Drift of sprays and dusts can affect people’s health and the environment and damage nearby crops.

Pesticide drift can pose health and environmental risks when sprays and dusts are carried by the wind and deposited on other areas, including:

  • Nearby homes, schools, playgrounds, or other public places;
  • Farm workers in adjacent fields; and
  • Wildlife, plants, and bodies of water.

Pesticide drift can also result in economic loss in the following ways:

  • Drift of herbicides can injure other crops on nearby farms, rendering the products unsellable; and
  • State and local agencies expend substantial resources investigating thousands of complaints about drifting pesticides each year.

Actions to reduce pesticide drift and runoff

When applying pesticides, the following best practices can help protect water resources by reducing runoff and spray drift:

  • Only apply the pesticide directly to the treatment area.
  • Be mindful of the location of storm drains, drainage ditches, gutters, or surface waters during a pesticide application and apply the product in a way that prevents the pesticide from entering these areas.
  • Apply pesticides during calm weather conditions and when rain is not predicted for the next 24 hours, whenever possible.
  • Rinse application equipment over the treated area to avoid runoff to water bodies or drainage systems.
  • When applying granular products, sweep any product that lands outside of the treated area back onto the treated area.

Reporting pesticide drift

In the case of pesticide drift, contact the National Pesticide Information Center (NPIC) or the state pesticide regulatory agency to report the incident.

Drift reduction technology

  • The voluntary pesticide DRT program encourages the manufacture, marketing, and use of safer spray technology and equipment that is scientifically verified to reduce pesticide drift.
  • To participate in the DRT program, EPA encourages technology manufacturers to test their technologies for drift reduction potential.

The Environmental Protection Agency’s (EPA’s) voluntary pesticide Drift Reduction Technology (DRT) program encourages the manufacture, marketing, and use of safer spray technology and equipment that is scientifically verified to reduce pesticide drift. The initial focus of the program is on spray technologies used primarily for pesticide applications to row and field crops by ground or aerial application equipment, but EPA hopes to expand the program to include technologies for orchard and vineyard crops.

To participate, EPA encourages technology manufacturers to test their technologies for drift reduction potential. The agency provides test methods for manufacturers on the EPA website and will use a rating system to indicate the level of potential drift reduction of tested technologies. Based on review of submitted test results, the agency will assign a DRT rating (one to four stars) to each technology that meets the minimum standard for drift reduction. Pesticide manufacturers are encouraged to state on their product labels that applicators should use DRT-rated technologies in applying pesticide products.

Technologies include:

  • Nozzles,
  • Spray shields, and
  • Drift-reducing adjuvant chemicals.

(An adjuvant is any substance added separately to a pesticide product, typically as part of a spray tank mixture, that will improve the performance of the pesticide product.)

The use of DRTs should result in significantly less pesticide from spray applications drifting and being deposited in areas not meant to be treated, and EPA may place fewer use restrictions on pesticide products that must be used in conjunction with DRTs.

Over time, EPA hopes the successful adoption of the DRT program will move the agricultural sector toward the widespread use of low-drift technologies. A robust adoption of this voluntary testing program by equipment and pesticide manufacturers and the widespread use of these technologies by pesticide applicators will provide a standardized, verified system for reducing pesticide drift.

Reporting pesticide incidents and adverse effects

  • Reporting procedures vary depending on the nature of the pesticide incident.

Through its pesticide registration, licensing, and labeling processes, the Environmental Protection Agency (EPA) must make the determination that a given product is safe for human health and the environment. Reporting pesticide incidents provides EPA with critical information while making these determinations, as they alert the agency to potential adverse effects. Incident reports help EPA determine whether:

  • The pesticide’s application directions need to be clarified,
  • EPA should restrict the uses of the pesticide, or
  • EPA should require additional protective safety equipment in the handling of the pesticide.

If, based on reports and subsequent risk analysis, it is found that the risks associated with exposures to a particular pesticide cannot be reduced, EPA has the authority to remove it from the marketplace.

Reporting procedures vary depending on the nature of the pesticide incident.

Incidents involving people

  • If a person has been exposed to a pesticide and has been harmed by that exposure, the priority is the health and safety of the affected person.

If a person has been exposed to a pesticide and has been harmed by that exposure, the first priority is the health and safety of the affected person. According to EPA, if someone has swallowed or inhaled a pesticide or been exposed to the product via the eyes or on the skin:

  • Call 911 if the person is unconscious, having trouble breathing, having convulsions, or has other symptoms indicative of an emergency.
  • Check the pesticide’s label for directions on first aid for that product.
  • Call the Poison Control Center at (800) 222-1222 for help with first aid information.
  • Call the National Pesticide Information Center (NPIC) at (800) 858-7378 to get more information about pesticide products and their toxicity.
  • Review EPA’s publication, Recognition and Management of Pesticide Poisoning, available on the agency’s website, to get information about symptoms caused by poisoning with specific pesticides and treatment information.

After the health and safety of the exposed person(s) is ensured, report the incident in one of the following ways described by EPA:

  • Call the NPIC to learn more about reporting pesticide exposure or illness. NPIC also provides summary reports to EPA on incidents but does not collect information for enforcement nor do they provide EPA with any personal identifying information.
  • Call the state pesticide regulatory agency, especially if there is concern about a possible illegal use of a pesticide. States generally have primary enforcement responsibility for pesticide misuse violations and for investigating possible instances of pesticide misuse.
  • If an individual suspects that federal pesticide regulations have been violated, submit a report to EPA on the agency’s website.
  • For incidents that may not involve violations of pesticide laws and regulations, make a report to EPA via email at Report.Pesticide.Incident@epa.gov. If available, useful information to provide in the report includes:
    • When, where, and how the exposure occurred,
    • Any medical outcome,
    • The number of people exposed,
    • The pesticide involved (provide the EPA registration number if available), and
    • Any other pertinent information.
  • Tell the product’s manufacturer, which is in turn required by law to submit reports of adverse effects to EPA. The manufacturer contact information is on the product label.
  • Contact the Occupational Health and Safety Administration (OSHA) depending on the type of incident and its outcome, for exposures in the workplace (see 29 CFR 1904.39 to determine if reporting is required).

Physicians and healthcare providers should also note that pesticide-related illness is a reportable condition in several states.

Incidents involving fish, wildlife, the environment, and pollinators

  • Wildlife and environmental incidents can be reported for all wildlife and for soil and water suspected or known to be affected by pesticide exposures.
  • EPA considers bee kill incident report data to help inform its pesticide regulatory decisions.

Pesticide incidents can be reported for all wildlife, including mammals, birds, fish, shellfish, reptiles, amphibians, insects (including bees and other pollinators), plants, soil, and water.

Reporting best practices from the Environmental Protection Agency (EPA) include:

  • Do not touch or disturb dead animals. Poisoned animals that are still alive may be taken to a veterinarian or wildlife rehabilitation center for treatment, and it is best to call the local animal control office or animal shelter for assistance. Rescue of ill animals should be attempted only by trained personnel who are properly protected from pesticide contamination and are knowledgeable about state and federal regulations related to the collection of wildlife.
  • Use the National Pesticide Information Center (NPIC)’s Ecological Incident Reporting Portal, which collects information from government organizations, the public, academia, wildlife rehabilitation centers, conservation societies, and beekeepers. NPIC provides reports to EPA on incidents but does not collect information for enforcement.
  • Contact the state pesticide regulatory agency, especially if there is concern about possible illegal use of a pesticide. States generally have primary enforcement responsibility for pesticide misuse violations and for investigating possible instances of pesticide misuse.
  • Contact the state’s department responsible for protecting fish, game, and natural resources, for incidents involving fish or wildlife.
  • Submit a report to EPA, if an individual suspects that federal pesticide regulations have been violated.
  • Tell the product’s manufacturer, which is in turn required by law to submit reports of adverse effects to EPA. The manufacturer contact information is on the product label.
  • Send EPA an email at Report.Pesticide.Incident@epa.gov, for any non-registrant wanting to report incidents that may not involve violations of pesticide laws and regulations:
    • For wildlife exposures, useful information for the report includes:
      • The type and number of animals exposed;
      • The condition of the animals;
      • The pesticide involved (EPA registration number if available); and
      • Any other pertinent information.
    • For environmental exposures affecting soils, plants, streams, rivers, and other bodies of water, useful information for the report includes:
      • Information on the pesticide involved (EPA registration number if available);
      • Number of plants, fish, or other aquatic organisms exposed;
      • The condition of the plants, fish, and other aquatic organisms; and
      • Any other pertinent information.

EPA considers bee kill incident report data to help inform its pesticide regulatory decisions, and information from these reports helps identify patterns of bee kills associated with the use of specific pesticides or active ingredients. Reports of bee kill incidents can be provided:

  • Through the NPIC’s Ecological Pesticide Incident Reporting portal, or
  • To EPA via email at beekill@epa.gov.

Incidents involving pets and domestic animals

  • Pesticide incidents involving pets and other domestic animals can be handled and reported in certain ways.

Pesticide incidents involving pets and other domestic animals can be handled and reported in the following ways:

  • If an animal needs immediate medical attention, call the local veterinarian, a local emergency clinic, or the National Animal Poison Control Center (NAPCC). NAPCC may charge a fee.
  • Tell the product’s manufacturer, which is in turn required by law to submit reports of adverse effects to the Environmental Protection Agency (EPA). The manufacturer contact information is on the product label.
  • For non-emergencies, call the National Pesticide Information Center (NPIC) at (800) 858-7378 to find out more about reporting a possible pesticide exposure or illness. NPIC provides summary reports to EPA on incidents but does not collect information for enforcement.
  • Contact the state pesticide regulatory agency, especially if there is concern about a possible illegal use of a pesticide. States generally have primary responsibility for investigating possible instances of pesticide misuse and for citing persons for pesticide misuse violations.
  • Submit a report to EPA if federal pesticide regulations have been violated.
  • Send EPA an email at Report.Pesticide.Incident@epa.gov, for any non-registrant wanting to report incidents that may not involve violations of pesticide laws and regulations. If available, useful information for the report includes:
    • Type and number of animals exposed;
    • Size, breed, and age of the animal;
    • Condition of the animal (e.g., symptoms exhibited and current health status);
    • The pesticide involved (include EPA registration number if available); and
    • Any other pertinent information.

For veterinarians wishing to report a pesticide incident involving pets and domestic animals, NPIC offers an online Veterinary Pesticide Incident Reporting Portal where veterinarians and their staff can submit reports to NPIC for surveillance purposes (but not enforcement). NPIC staff are also available to veterinarians for general pesticide-related questions regarding animal exposures.

Reporting requirements for pesticide manufacturers

  • Pesticide manufacturers are required to inform the EPA about harmful effects of their products under federal law.

Pesticide manufacturers (also known as registrants) are required to inform the Environmental Protection Agency (EPA) about harmful effects of their products under federal law, specifically the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 6(a)(2).

Adverse effect information that registrants must report includes:

  • New information derived from scientific studies (e.g., unexpected levels of toxicity).
  • Reports of incidents of harmful effects resulting from the use of their pesticide products.

EPA considers incident information submitted by registrants and all others in evaluating the safety of pesticide products. The agency provides Voluntary Incident Reporting Forms and Instructions on its website that provide useful tips and suggestions for meeting reporting requirements under FIFRA 6(a)(2). Use of these specific forms for required reporting is voluntary, and the forms have been developed by pesticide registrants and trade association representatives to meet incident reporting requirements.

Instructions and mailing addresses for submitting reports are available on EPA’s website.

Penalties

  • Violations of FIFRA can result in steep financial penalties, additional citations, fines, or other civil or criminal penalties that may be assessed by state or local environmental agencies.

The Environmental Protection Agency (EPA) regulates the distribution, sale, and use of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Violations of FIFRA can result in steep financial penalties, not to mention additional citations, fines, or other civil or criminal penalties that may be assessed by state or local environmental agencies.

While penalties at the state and/or local level will vary, the current FIFRA civil monetary penalties assessed by federal EPA (as adjusted for inflation) are as follows:

  • $20,528 — Statutory civil monetary penalty for a violation that occurs or occurred after November 2, 2015, where the penalty is assessed on or after December 23, 2020.
  • $20,288 — Statutory civil monetary penalty for a violation that occurred after November 2, 2015, where the penalty is assessed on or after January 13, 2020, but before December 23, 2020.

State requirements

  • A great deal of environmental legislation and enforcement is conducted at the state level, and pesticide management is no exception.
  • States may have stricter rules than those outlined by FIFRA.

A great deal of environmental legislation and enforcement is conducted at the state level, and pesticide management is no exception. Check with state environmental agencies for information about pesticide sale, distribution, and use, as some states may have stricter rules than those outlined in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other federal laws.

State law may also affect the organization’s ability to manage pesticides as universal waste. Some states, including California, Maine, and Washington, do not recognize pesticide as a universal waste, for example.

It should be noted that the National Pesticide Information Center (NPIC) website provides a list of state and local contacts for pesticide information across U.S. states and territories.

What are pesticides?

  • A pesticide is 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.
  • The term pesticide product is another term defined by EPA, and pesticide products contain both active and inert ingredients.

A “pesticide” is 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. See the technical definition of the term pesticide at 40 CFR 152.3.

“Pesticide product” means 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. Pesticide products contain both “active” and “inert” ingredients:

  • An “active ingredient” prevents, destroys, repels, or mitigates a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer.
  • All other ingredients are called “inert ingredients” by federal law. They are important for product performance and usability.

Active ingredients

Active ingredients are the chemicals in a pesticide product that act to control the pests. Active ingredients must be identified by name on the pesticide product’s label together with its percentage by weight.

There are several categories of active ingredients:

  • Conventional — All ingredients other than biological pesticides and antimicrobial pesticides.
  • Antimicrobial — Substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms, whether bacteria, viruses, or fungi, on inanimate objects and surfaces.
  • Biopesticides — Types of ingredients derived from certain natural materials.

Inert ingredients

Pesticide products contain at least one active ingredient and other intentionally added ingredients. Called inert ingredients by the federal law, they are combined with active ingredients to make a pesticide product. Inert ingredients are chemicals, compounds, and other substances, including common food commodities (e.g., certain edible oils, spices, or herbs) and some natural materials (e.g., beeswax or cellulose).

The name “inert” does not mean non-toxic. All inert ingredients must be approved by the Environmental Protection Agency (EPA) before they can be included in a pesticide. EPA reviews safety information about each inert ingredient before approval. If the pesticide will be applied to food or animal feed, a food tolerance is required for each inert ingredient in the product, and the agency may limit the amount of each inert ingredient in the product.

Inert ingredients play key roles in pesticide effectiveness and product performance. Examples of functions that inert ingredients can serve include:

  • Acting as a solvent to help the active ingredient penetrate a plant’s leaf surface;
  • Improving the ease of application by preventing caking or foaming;
  • Extending the product’s shelf-life;
  • Improving safety for the applicator; and
  • Protecting the pesticide from degradation due to exposure to sunlight.

Under federal law, the identity of inert ingredients is confidential business information. The law does not require manufacturers to identify inert ingredients by name or percentage on product labels. In general, only the total percentage of all inert ingredients is required to be on the pesticide product label.

Intended use

It should be noted that EPA says that it is the “intended use” of a product that determines if it is a pesticide. If a company can answer “yes” to the any of the following questions, the product is a pesticide:

  • Claims — Does the product’s label or distributor claim that the product can or should be used as a pesticide?
  • Composition — Is the product composed of one or more active ingredients that have no commercially valuable use other than for a pesticidal purpose?
  • Knowledge that the substances will be used as a pesticide — Does the distributor know that the product will be used for a pesticidal purpose?

Other key definitions

  • Various terms are crucial to understanding pesticide laws and regulations.

Active ingredient: The ingredient that prevents, destroys, repels, or mitigates a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer.

Antimicrobial pesticide: A substance or mixture of substances that destroys or suppresses the growth of disease-causing microbes and pathogens including bacteria, viruses, or fungi.

Appurtenance: Any equipment or device which is used for the purpose of transferring a pesticide from a stationary pesticide container or to any refillable container, including but not limited to, hoses, fittings, plumbing, valves, gauges, pumps, and metering devices.

Biopesticides: Naturally occurring substances that control pests (i.e., biochemical pesticides), microorganisms that control pests (i.e., microbial pesticides), and pesticidal substances produced by plants containing added genetic material (i.e., plant-incorporated protectants (PIPs)).

Crop advisor: Any person who is assessing pest numbers or damage, pesticide distribution, or the status or requirements of agricultural plants. The term does not include any person who is performing hand labor tasks.

Early entry: Entry by a worker into a treated area on the agricultural establishment after a pesticide application is complete, but before any restricted-entry interval for the pesticide has expired.

Fumigant: Any pesticide product that is a vapor or gas, or forms a vapor or gas on application, and whose method of pesticidal action is through the gaseous state.

Inert ingredients: Ingredients in a pesticide that do not act as active ingredients.

Label: Any text or images printed directly on, or attached to, a pesticide product or its packaging.

Labeling: The label on a pesticide product, as well as any printed or written material that accompanies the product (for example, a booklet or manual). Labeling can also include material to which the label (or other labeling material) refers.

Minimum risk pesticide: A pesticide that poses little to no risk to human health or the environment and is therefore exempted by the Environmental Protection Agency (EPA) from the requirement that it be registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Restricted-entry interval: The time after the end of a pesticide application during which entry into the treated area is restricted.

Restricted use pesticide: A pesticide that is classified for restricted use under the provisions of FIFRA 3(d) and 40 CFR 152 Subpart I.

Rinsate: The liquid resulting from the rinsing of the interior of any equipment or container that has come in direct contact with any pesticide.

Rodenticide: A pesticide or poison used to kill rodents such as rats and mice. Common types of rodenticides include anticoagulant compounds as well as bromethalin, cholecalciferol, and zinc phosphide.

Runoff: Surface water leaving the target site.

Secondary containment unit: Any structure, including rigid diking, that is designed and constructed to intercept and contain pesticide spills and leaks and to prevent runoff and leaching from stationary pesticide containers.

Soil fumigants: Pesticides that are applied to soil that form a gas to control pests that live in the soil and may disrupt plant growth and crop production.

Toxicity: The property of a pesticide that refers to the degree to which the pesticide, and its degradates and metabolites, can cause an adverse physiological effect on an organism.

Laws and regulations that apply to pesticides

  • Several laws and regulations relate to pesticides.

Federal pesticide laws and statutes

  • Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. — FIFRA provides for federal regulation of pesticide distribution, sale, and use, and requires all pesticides sold or distributed in the United States (including those that are imported) to be registered by the Environmental Protection Agency (EPA). This also covers labeling requirements and risk assessments by EPA.
  • Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq. — The FFDCA authorizes EPA to set tolerances (i.e., maximum limits) for pesticide residues on foods. To determine tolerances, EPA must deem the tolerance “safe,” which is defined as “reasonable certainty that no harm will result from aggregate exposure to the pesticide residue.” EPA may grant exemptions to tolerance requirements in some cases.
  • Food Quality Protection Act (FQPA), Public Law 104–170 — This law amended both FIFRA and FFDCA, which introduced additional factors EPA must consider in establishing pesticide tolerances on food or feed and directed the agency to review each pesticide registration at least once every 15 years.
  • Pesticide Registration Improvement Act (PRIA), Public Law 108–199 — Also amending FIFRA and FFDCA, PRIA established service fees for registration of pesticides as well as decision review time periods for EPA.

Federal pesticide regulations

Federal EPA regulations implementing the pesticide laws and statutes can be found at 40 CFR Parts 150 to 189. These regulations establish policies, requirements, and procedures. They include, but are not limited to:

  • Part 152: Pesticide Registration and Classification Procedures
  • Part 155: Registration Standards and Registration Review
  • Part 156: Labeling Requirements for Pesticides and Devices
  • Part 162: State Registration of Pesticide Products
  • Part 165: Pesticide Management and Disposal
  • Part 168: Statements of Enforcement Policies and Interpretations
  • Part 170: Worker Protection Standard
  • Part 171: Certification of Pesticide Applicators
  • Part 180: Tolerances and Exemptions for Pesticide Chemical Residues in Food

Other laws and regulations applicable to pesticides

  • Endangered Species Act (ESA), 16 U.S.C. 1531 et seq. — The ESA is directed toward the conservation of threatened and endangered plants, animals, and habitats. EPA must consider whether the registration of any pesticide will further endanger any listed species and/or destroy or adversely change any critical habitat for those species.
  • Hazard Communication Standard, 29 CFR 1910.1200 — Pesticides present a potential workplace hazard to employees, and these hazards must be communicated via information made available to employees via safety data sheets.
  • Standards for Universal Waste Management, 40 CFR 273 — Pesticides are one of five hazardous wastes that may be managed as universal waste under federal EPA regulations. Note, however, that many states are authorized to manage waste regulations in their states, and not all states recognize pesticides as universal waste.

State and local rules and regulations — Check state and local environmental regulations to determine additional or more stringent requirements that may apply. The National Pesticide Information Center (NPIC) website provides a list of local contacts for pesticide information across U.S. states and territories.

Pesticide registration and labeling

  • A manufacture must register a pesticide before it can sell it in the United States.
  • A proposed pesticide label must be submitted with the pesticide registration application.

Before manufacturers can sell pesticides in the United States, EPA must evaluate them thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA will grant a registration that permits a pesticide’s distribution, sale, and use only after the company meets the scientific and regulatory requirements.

As part of any pesticide registration application submitted to EPA, applicants must provide a proposed label containing detailed information. During its review, the agency may approve the label as submitted, approve the label with comments, or disapprove the submitted label.

Summary of requirements

Cited under 40 CFR 152 to 156, registration and labeling requirements include:

  • Submitting a Pesticide Registration Notice to begin the process of registering a new pesticide, new formula, or new use for an existing pesticide.
  • Completing and submitting an original Application for Pesticide Registration/Amendment form.
  • Paying fees with application submission.
  • Obtaining an EPA Company Number before submitting a first product with EPA. (For subsequent registrations, refer to the existing company number.)
  • Obtaining an EPA Establishment Number using EPA Form 3540-8, if a pesticide producer plans to register its own products.
  • Submitting a master label to EPA for review and approval.

Pesticide registration

  • 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.
  • Determine if a fee is required and, if so, identify the amount and pay the fee when submitting the application.

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. 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 40 CFR 152.30.

Under the registration review process, 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.

Summary of requirements

  • Understand the exclusions and exemptions at 40 CFR 152.
  • Obtain an EPA Company Number before registering the 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 a pesticide producer who plans to register its 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 submitting the 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 acknowledgment; 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 a product is to be marketed.
  • 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.)

Company and establishment numbers

  • A “company number” is a unique identifier assigned to a company that wishes to register a pesticide with the EPA.
  • Registrants must obtain a company number prior to registering their first product with EPA.

A “company number” is a unique identifier assigned to a company that wishes to register a pesticide (e.g., herbicide, rodenticide, or antimicrobial) with the Environmental Protection Agency (EPA). A company number is also necessary for a company that plans to produce pesticides or devices. Such production requires the company to obtain a “Pesticide-Producing or Device-Producing Establishment Number.” The company number is part of the establishment number.

How to obtain an EPA company number

Registrants must obtain a company number prior to registering their first product with EPA. For subsequent products or amendment to existing registrations, the registrant must refer to this company number. (Note: Registrants who plan to produce their own products will also need to obtain an “establishment number.”)

The registrant must submit a signed letter on company letterhead to request a company number and establish an official address with EPA as described in the agency’s guidance, “How to Obtain a Company Number and Register an Official Address.” EPA will direct all future correspondence to the official address. The registrant must keep this official address record up to date.

In its request for a company number, a foreign company must designate a U.S. agent to receive correspondence and represent it in matters concerning an application. A U.S. registrant may also designate an agent. The letter should include a statement authorizing the agent to act in all matters concerning the registration of the product with EPA. It should also include a statement acknowledging that all official correspondence from EPA will be directed to the agent.

The request for a new company number can be made via email with the signed letter on company letterhead (including all needed information) as an attachment.

How to obtain an EPA establishment number

When producing or formulating a pesticide, it is necessary to register the place or facility where the pesticide or device will be produced. To register an establishment, EPA Form 3540-8, Application for Registration of Pesticide-Producing Establishments must be completed and submitted to EPA as follows:

  • For domestic establishments, the completed application should be sent to the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. The instructions for Form 3540-8 list the Regional Offices’ mailing addresses and telephone contacts.
  • For foreign establishments, applications should be submitted to EPA headquarters at the address listed in the instructions on how to properly complete Form 3540-8.

To request termination of a pesticide-producing or device-producing establishment, domestic establishments should notify the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. Foreign establishments should notify the EPA Headquarters Office listed in the instructions for Registering Establishments on the EPA website.

Registration application overview

  • Companies must submit an application for a registration action.

Companies must submit an application for a registration action, such as to register a new pesticide active ingredient, new product for an existing pesticide, or a new use for an existing product.

The company’s application typically includes:

  • A service fee;
  • Forms describing the requested action;
  • The identity and quantity of all chemicals in the product;
  • Data on potential risks to human health and the environment, including about the potential for pesticide residues on food (if applicable);
  • Proof that the product manufacturing process is reliable;
  • Labeling, including directions for use, contents, and appropriate warnings; and
  • Evidence of meeting all legal and financial obligations.

EPA publishes a notice of receipt in the Federal Register for each application for registration of a new product that contains a new pesticide active ingredient or that proposes a new use for an existing pesticide.

Applications are assigned to the appropriate pesticide division, where it is processed and tracked. An agency project manager is then assigned to:

  • Complete a detailed review of the application;
  • Assign and coordinate the appropriate scientific review;
  • Implement priorities and timetable as set by law;
  • Coordinate administrative action; and
  • Communicate with the applicant, otherwise known as the registrant, about the review.

Registration procedures

  • A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package.
  • EPA welcomes requests for a pre-registration meeting.
  • PR Notice 11-3 discusses both the recommended and the required procedures for submitting FIFRA data.

Procedures for submitting a complete application for registration of a pesticide product are detailed in regulations at 40 CFR 152.40 to 152.55. The Environmental Protection Agency (EPA) has also published the Pesticide Registration Manual as a resource for companies and individuals who want to have their pesticide products registered for sale in the United States. Detailed information for pesticide registrants (i.e., the company or individual applying to register a pesticide) concerning their responsibilities before, during, and after the review process is included in the manual, which can be found on the agency’s website.

A separate application for registration must be made for each pesticide product that will be distributed or sold. A pesticide product registration is required for each manufacturing use product or end use formulation.

Note: EPA has classified some or all of the uses of certain pesticides as “Restricted Use.” The “Restricted Use” classification restricts a product, or its uses, to use by a certified pesticide applicator or under the direct supervision of a certified applicator. Criteria used for determining whether a product requires the restricted use classification can be found in 40 CFR 152.170.

Cover letter

A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package. It should also contain the email address of the applicant in order to receive registration milestone tracking emails.

Application form

Complete and submit an original Application for Pesticide Registration/Amendment Form (EPA Form 8570-1) with each application for registration. When EPA receives the application (and the applicable fee required), the agency will screen the application during a 21-day period to determine if it contains all required forms, labeling, and data formatted as described in the agency’s guidance in Pesticide Registration (PR) Notice 11-3, as well as documentation of fee payment.

The fee payment documentation may include a request for a fee reduction or waiver or an exemption. Any deficiencies identified during the 21-day screening that are not corrected by the applicant may lead to the agency’s rejection of the application. EPA will keep 25 percent of the fee.

Pre-registration meeting

EPA welcomes requests for a pre-registration meeting. This type of meeting can provide useful guidance to the applicant regarding information needed for registration. Applicants are encouraged to contact the appropriate branch assigned to the active ingredient in their product before submitting an application for registration. Contact the ombudsman for the division if the appropriate branch is unknown.

Pesticide Registration (PR) Notice 11-3

PR Notice 11-3 discusses both the recommended and required procedures for submitting Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data. All required procedures contained within the document, generally indicated by use of the word “must,” were previously made mandatory by statute or regulation. Where indicated by the use of non-mandatory language such as “may,” “should” and “can,” EPA provides recommendations or guidance.

The PR Notice applies to all data that are submitted to EPA to support any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:

  • Application for registration or amended registration of a pesticide product under FIFRA 3 or 24.
  • Submission of data required in conjunction with reregistration of a currently registered product under FIFRA 4 (or its registration review under FIFRA 3).
  • Application for an experimental use permit under FIFRA 5.
  • Submission of data in response to a notice issued by EPA under FIFRA 3(c)(2)(B).
  • Petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under Federal Food, Drug and Cosmetic Act (FFDCA) 408.
  • Studies submitted under FIFRA 6(a)(2).

Electronic submissions

Applications for pesticide registration can now be submitted electronically to EPA. Forms, studies, and draft product labeling may all be submitted via the Pesticide Submission Portal (PSP) which is accessed through EPA’s Central Data Exchange (CDX) Network (user registration is required). Application materials, tools, and resources for submission are all available on EPA’s website. Registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools based on EPA’s XML guidance may use the PSP and forego the costs of sending physical copies to EPA.

Note that applicants do not need to submit multiple electronic copies of any pieces of their applications. In PR Notice 2011-3, EPA made clear that the requirement to submit multiple copies of data is applicable only to paper submissions and, similarly, EPA interprets the requirement to submit five copies of draft labeling in 40 CFR 152.50(e) to apply only to applications made on paper. Since electronic submissions are easily reproducible, EPA will accept electronic applications containing one copy of all the required elements.

Registration fees

  • A fee (or a waiver from paying the fee) is required for certain types of actions.
  • Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.
  • All registrations are subject to an annual maintenance fee.

The Environmental Protection Agency (EPA) keeps a fee schedule current on its Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) webpage. This is the first stop for determining the application fee amount.

A fee (or a waiver from paying the fee) is required for the following types of actions:

  • New active ingredients;
  • New uses;
  • New products;
  • Certain tolerances;
  • Certain amendments;
  • Certain inert ingredients;
  • Certain combination products;
  • Cancer reassessments and certain ecological/endangered species assessments;
  • Manufacturing use products (MUPS);
  • Experimental use permits (EUPS);
  • Human study protocols and completed studies that require review by the human studies review board;
  • Certain covered actions that require external review by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) science advisory panel;
  • Gold Seal letters; and
  • Data extension requests.

FIFRA 33(b)(2)(F) directs the agency to reject any application submitted without the required registration service fee. Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.

A certification of payment should be the first page of the submission or application and precede a cover letter or fee waiver or reduction request to enable the agency to match a payment with an application.

To help applicants identify the appropriate fee and pay it in advance of submitting an application (pre-payment) or upon submission to EPA, the “Fee Determination Decision Tree” is available on the agency website. Through a series of questions and answers, pesticide registration applicants are led to the appropriate fee category and fee.

Also, chapter 5 of the Pesticide Registration Manual offers in-depth information about registration fees.

Annual pesticide registration maintenance fees

All registrations are subject to an annual maintenance fee. Affected applicants will be contacted by mail in November with instructions for submitting the fee, which is due by the fifteenth of January. No extensions of this due date are possible. The amount of the per product fee will vary from year to year as the fee is dependent upon the projected number of products for which registrants will pay this fee.

Although there are procedures for requesting a fee waiver for individual products, maintenance fees will be reduced by 25 percent for the first registration only, if the applicant can show that:

  • The applicant has 500 or fewer employees globally,
  • During the three-year period prior to the most recent maintenance fee billing cycle the applicant has average annual gross revenue from all sources that do not exceed $10,000,000, and
  • The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet certain narrow criteria in two categories: minor agricultural use products and public health pesticides.

EPA assessment

  • EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use are necessary to protect the environment.
  • EPA uses a four-step process for its human health risk assessments.
  • As a final step of evaluation, EPA implements an overall risk assessment and peer review.

The Environmental Protection Agency (EPA) evaluates new pesticides before they can enter the market and re-evaluates existing pesticides to ensure they continue to meet appropriate safety standards.

Ecological risk assessment

EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use or proposed use are necessary to protect the environment. Many plant and wildlife species can be found near or in cities, agricultural fields, and recreational areas. Before allowing a pesticide product to be sold on the market, EPA ensures that the pesticide will not pose any unreasonable risks to plants, wildlife, and the environment. This is done in phases:

  • Planning phase: Planning and scoping process — EPA begins the process of ecological risk assessment with planning and research.
  • Phase 1: Problem formulation — Information is gathered to help determine what plants and animals are at risk and need to be protected.
  • Phase 2: Analysis — This is the determination of what plants and animals are exposed and to what degree they are exposed, and whether or not that level of exposure is likely to cause harmful ecological effects.
  • Phase 3: Risk characterization — Risk characterization includes two major components (risk estimation and risk description). Risk estimation combines exposure profiles (i.e., the findings of exposure characterization) and effects from exposure. Risk description provides information important for interpreting the risk results and identifies a level for harmful effects on the plants and animals of concern.

Human risk assessment

A human health risk assessment is the process to estimate the nature and probability of adverse health effects in humans who may be exposed to chemicals in contaminated environmental media, now or in the future. Human health risk assessments address questions such as:

  • What types of health problems are caused by pesticides in the environment?
  • What is the chance that people will experience problems when exposed to different levels of pesticides?
  • Is there a low level below which some chemicals don’t pose a human health risk?
  • What pesticides are people exposed to and for how long?
  • Are legal limits for pesticide residues in food (tolerances or maximum residue limits) protective of human health?
  • Are people more likely to be susceptible or exposed to pesticides because of factors such as age, genetics, pre-existing health conditions, ethnicity, gender, where they work, where they play, what they eat, etc.

EPA uses the National Research Council’s four-step process for its human health risk assessments:

  1. Hazard identification examines whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances.
  2. Dose response assessment examines the numerical relationship between exposure and effects.
  3. Exposure assessment examines what is known about the frequency, timing, and levels of contact with a substance.
  4. Risk characterization examines how well the data support conclusions about the nature and extent of the risk from exposure to pesticides.

Cumulative risk assessment

The Food Quality Protection Act of 1996 requires EPA to also conduct a cumulative risk assessment for pesticides that have a common mechanism of toxicity. A common mechanism of toxicity is identified when two or more chemicals or other substances cause a common toxic effect(s) by the same, or essentially the same, sequence of major biochemical events.

Final assessment and review

As a final step of evaluation, EPA implements an overall risk assessment and peer review. The agency reviews all the scientific data on the pesticide product and develops comprehensive risk assessments that examine the potential effects of the product or ingredients on the human population and environment. Health and environmental risk assessments undergo a process of peer review by scientific experts.

EPA risk management and regulatory decisions

  • After completing its risk assessments and peer review, EPA makes risk management and regulatory decisions.

After completing its risk assessments and peer review, the Environmental Protection Agency (EPA) makes risk management and regulatory decisions to:

  • Consider the results of the risk assessments and the peer review;
  • Research alternative pesticides that are already registered;
  • Review any measures needed to mitigate any identified risks;
  • Discuss with the applicant if modifications to the product or labeling must be made to mitigate risk;
  • Establish new food tolerances if needed, after publishing notices for comment in the Federal Register;
  • Reject or grant the registration; and
  • Publish in the Federal Register a notice of issuance of the registration, if granted.

Required initial/annual reporting

For new establishments, an initial report must be submitted no later than 30 days after the first registration of each establishment. The records that must be maintained and the retention period are described in 40 CFR 169.

All active establishments are required to submit an annual production report on Environmental Protection Agency (EPA) Form 3540-16, Pesticide Report for Pesticide-Producing Establishments by March 1 of each year to the appropriate EPA Regional Office listed in the “Instructions for Completing EPA Form 3540-16.”

Pesticide labels and labeling

  • Unlike most other types of product labels, pesticide labels are legally enforceable.

Pesticide product labels and labeling provide critical information about how to safely and legally handle and use pesticide products. A pesticide product’s label and labeling are of utmost importance as they are the primary mechanism to inform the end-user about how to use and apply the product to achieve the product’s useful functions, as well as which precautions must be followed to protect both human health and the environment.

Label versus labeling

A pesticide “label” includes any text or images printed directly on, or attached to, the product or its packaging. “Labeling,” on the other hand, includes the label, as well as any printed or written material that accompanies the product (for example, a booklet). Labeling can also include material to which the label (or other labeling material) refers. For instance, if a label refers to a manual on how to conduct a procedure, that manual is also labeling that the user must follow and the Environmental Protection Agency (EPA) must review and approve before the product may be sold or distributed.

The label is the law

Every pesticide product must bear a label containing the information specified by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S. Code section 136 et seq., and its implementing regulations at 40 CFR 156. FIFRA and Part 156 govern what must be included on pesticide labels.

Unlike most other types of product labels, pesticide labels and labeling are legally enforceable, and all of them carry the statement: “It is a violation of federal law to use this product in a manner inconsistent with its labeling.” One could say, “The label is the law.” Enforcement of pesticide regulations and label requirements is primarily carried out by state agencies acting under cooperative agreements with EPA.

Label review and approval

As part of any pesticide registration application submitted to EPA, applicants must provide a proposed label containing detailed information. The agency ensures that the pesticide label translates scientific data about the potential health and environmental effects of a pesticide into a set of conditions, directions, precautions, and restrictions that define who may use a pesticide, as well as where, how, how much, and how often it may be used.

During its review, EPA may approve the label as submitted, approve the label with comments, or disapprove the submitted label. The label must be approved before a pesticide can be sold or distributed in the United States.

Ultimately, the accuracy of a label is vital as it may impact:

  • EPA and other agencies that use the label to manage and mitigate pesticide risks;
  • EPA and other agencies that enforce pesticide production, distribution, and use;
  • Registrants, including pesticide manufacturers, and their supplemental distributors;
  • Pesticide applicators who rely on the label for hazard and safety information and use directions to ensure safe and effective use;
  • Bystanders and other individuals who may be exposed to the pesticide; and
  • Courts that consider a label to be a legal document.

Summary of requirements

  • Determine whether the product is or is not a pesticide. See 40 CFR 152.
  • Determine whether the product is exempted from FIFRA. See 40 CFR 152.
  • Determine whether the pesticide product is exempted from registration. See 40 CFR 152.
  • If the pesticide product is unregistered and non-exempt, then it is not exempted from registration:
    • Develop draft labeling that meets the Part 156 requirements, including for content and format.
    • Follow the application procedures at 152.50 for submitting applications and draft labeling. Submit five copies of the proposed draft labeling with an application. The draft labeling may be typed or otherwise printed but must be legible, reproducible, and on 8-1/2 x 11-inch paper. However, EPA encourages electronic submission. See the EPA Electronic Submission of Labels webpage for information.
    • EPA will review draft labeling submitted with the application and can approve the label as submitted, approve the label with comments, or disapprove the submitted label.
    • Once EPA has granted a registration, EPA not only notifies the registrant of the decision but also will approve a submitted label for the product.
    • Include an approved label on every package on all registered products.
    • Do not alter or change the label after the registration approval. If the product was previously registered with EPA and a change to the registration, such as a change to the labeling text, is needed, file an application to amend the registered product.
    • Do not sell or distribute a pesticide if any claims made for it differ from the claims made on labeling required for registration. (Advertising claims for a pesticide product must not contradict claims made in the product’s labeling.)
  • Ensure that supplemental distributor products and their distributor labeling comply with 152.132. Distributor labels are not submitted for approval, but a Notice of Supplemental Distribution must be submitted to EPA before supplemental distribution of the product. A distributor label must be the same as that of the registered product label with some important exceptions.

Guidance

Given the high importance of labels in pesticide management, application, and regulatory enforcement, EPA has compiled a comprehensive Label Review Manual (LRM), which is available on the agency website. This instructional aid compiles existing interpretations of statutory and regulatory provisions and reiterates existing agency policies. The LRM also provides assistance and insight into how pesticide labels should generally be drafted.

Further regulatory guidance may be found in EPA Pesticide Registration Notices (PR Notices or PRN).

Types of labels/labeling

  • Master label, sub-label, supplemental distributor labeling, and supplemental labeling are the four types of pesticide labels and labeling.

There are four types of pesticide labels and labeling:

  • Master label,
  • Sub-label (split-label),
  • Supplemental distributor labeling, and
  • Supplemental labeling.

Master label

The master label displays the claims and directions for the approved uses of a given product and all associated required labeling. All other labeling for the product must not contain any text beyond that which is approved in the master label (with the exception of the supplemental label).

This label is filed with the Environmental Protection Agency (EPA) once it is stamped “accepted.”

Sub-label (split-label)

A sub-label or split-label displays the claims and directions for only a portion of the approved uses under a given master label. The label is complete, listing all of the required label elements, but the company may want the label displayed differently for marketing purposes. EPA allows registrants to distribute or sell a product under a sub-label or split-label provided that no changes would be necessary to the precautionary statements, use classification, or packaging of the product.

A sub-label or split-label only contains labeling text that also appears on the master label. When a sub-label is submitted with additions not on the accepted master label, a new master label containing all the uses currently approved under the product’s registration is required. Only the master label will be stamped “accepted.”

Supplemental distributor labeling

Supplemental distributor labeling includes labels for a product that is registered to one company but distributed by another company (sometimes referred to as a “sub-registrant”) under that company’s name. These labels must be the same as the labels for the registered product, with the following exceptions:

  • Product name
  • Name and address
  • Registration number (EPA Reg. No. xxxx-xx-xxxx, where the third set of numbers refers to the distributor’s company number)
  • Establishment

In addition, claims may be deleted, but new claims that differ from the parent label cannot be added to a distributor label.

The parent company must notify EPA before distribution by submitting a Notice of Supplemental Distribution (EPA Form 8570-5).

EPA does not receive or review supplemental distributor labeling, but EPA can review the distributor company names to ensure that they are not misleading. The parent company is responsible for ensuring that the supplemental distributor is in compliance with these requirements.

Supplemental labeling

Supplemental labeling includes labels that contain newly approved uses, use directions, or other instructions that have been added since the last accepted master label. These new uses and directions are incorporated into the EPA master label, but because they are not on those products already in the channels of trade, they are distributed with the product by the registrant or distributors.

These are partial labels, so they must include a statement referring the user to the product label for complete directions and precautions, and a statement that the labeling must be in the possession of the user. The user must follow the supplemental label, the product’s container label, and all other labeling that comes with the product in order to apply it in a way that reduces risk and maximizes efficacy.

The supplemental labeling must be submitted and stamped “accepted” by EPA prior to distribution. EPA requires that these labels include the following information:

  • Product name
  • EPA registration number
  • Restricted use classification statement (if applicable)
  • “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”
  • “The labeling must be in possession of the user at the time of application.”
  • “Read the label affixed to the container for [product name] before applying.”
  • “Use of [product name] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [product name].”

Normally, supplemental labeling will be incorporated into the affixed label at the next printing of the product label or within 18 months. The agency recommends an expiration date of 18 months after acceptance on supplemental labels. However, this might not be done in all cases, such as if the directions for use are subject to continual, frequent change.

Labels that require review

  • Various types of labels require EPA review, as discussed here.

Labels for products containing new active ingredients and/or new uses — This type of submission involves a new active ingredient that is currently not registered by the Environmental Protection Agency (EPA) as a pesticide or a new use of an existing product.

Labels for new products containing existing active ingredients — This type of submission involves an application for registration of a product containing an active ingredient that is currently registered for use as a pesticide in other products.

Labels for technical grade and manufacturing use products — This type of submission involves a product that is used to manufacture or formulate other pesticides.

Labels for products requiring amendments — This type of submission involves an application for an amendment to a currently registered pesticide. There are two kinds of amendment submissions:

  • No data review required. An example is an amendment for the addition to the label of a new site or pest that has been previously approved by EPA for other products containing the same active ingredient. For products composed of multiple active ingredients, the proposed new site or pest must be previously approved for all of the active ingredients.
  • Data review required. An example is an amendment involving a new use, a new application rate, or a change in precautionary statements. This is an action not previously approved by EPA, and a data submission and review are necessary. Review of the label will be based on the conclusions of the data reviews from the product chemists, toxicologists, or efficacy reviewers. Generally, the specific reviews will only affect a small portion of the label; the rest of the text should remain unchanged from the originally accepted label.

Fast track labels — This type of submission involves no data or only product chemistry data.

Me-too registration labels — This type of submission involves a pesticide product and proposed use that is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.

Labels for products with efficacy data requirements — This type of submission involves products for which efficacy data is required. Efficacy studies document how well pesticide products perform as pest control agents. Even though registrants/applicants must conduct efficacy studies, the agency only routinely requires the submission of these studies for certain types of products. EPA reviews efficacy data (also referred to as product performance data) when a pesticide product bears a claim to control pest organisms that pose a threat to human health. Such pests include, but are not limited to:

  • Microorganisms that are infectious to humans in any area of the inanimate environment;
  • Vertebrates (e.g., rodents, birds, bats, and skunks) that may directly or indirectly transmit diseases to or injure humans; or
  • Insects that carry human diseases (e.g., mosquitoes and ticks).

Public health pests are listed in Pesticide Registration (PR) Notice 2002-1. EPA also requires submission of efficacy data to support claims for the control of termites. On a case-by-case basis, the agency may require substantiation of an efficacy claim.

Labels for special local need (SLN) products — This type of submission involves products for which particular states register additional uses to meet their specific needs. Such registrations are for distribution and use only within a particular state to meet an SLN. Unlike other labels, EPA does not actively accept SLN labels. Instead, EPA has 90 days to disapprove it; otherwise, it is considered an accepted label under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Experimental use permits — Experimental use permits authorize testing (across an area greater than 10 acres of land or one acre of water) of unregistered pesticides or registered pesticides’ unregistered uses.

Labels that do not require review

  • With supplemental distributor labeling, EPA reviews the parent company’s labeling, but not the distributor’s labeling.
  • Certain types of products are exempt from FIFRA because EPA determined them to be adequately regulated by another federal agency or of a character that is unnecessary to be subject to FIFRA.

Supplemental distributor labeling — This type of submission involves labels for a product that is registered to one company, but distributed by another company. The Environmental Protection Agency (EPA) reviews the parent company’s labeling, but not the distributor’s labeling. Supplemental distributor products are still subject to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA can review distributor company names to ensure that they are not misleading.

Labels for products exempted from FIFRA by 40 CFR 152.20 and 152.25 — Certain types of products are exempt from FIFRA because EPA determined them to be:

  • Adequately regulated by another federal agency, or
  • Of a character that is unnecessary to be subject to FIFRA, such as insect pheromones or products containing only certain listed ingredients EPA determined to pose minimum risks.

Labels for modified products requiring notification and non-notification — This type of submission involves product modifications that do not require EPA approval. These modifications must have no potential to cause unreasonable adverse effects to the environment. Some of these modifications can be made simply by notifying EPA (known as notification). Examples include:

  • Adding or changing alternate brand names,
  • Changing primary product name, or
  • Changing symbols and graphics (except skull and crossbones).

Other modifications may be made without notifying EPA (known as non-notification). Examples include:

  • Correcting typographical and printing errors,
  • Changing package size and net contents (with some exceptions), and
  • Changing name or address of registrant.

Label compliance and enforcement

  • There are four steps in the pesticide label review and enforcement process.
  • Imprecise or vague language can make a label misleading and unenforceable.

Label review

When conducting a label review, the Environmental Protection Agency (EPA) considers:

  • Whether a user can understand and follow the label; and
  • Whether the label is clear, accurate, and consistent with EPA policy and is enforceable by the states or EPA regions.

EPA can stamp a label as “accepted,” send the label back to the manufacturer for corrections, or begin an investigation to detect violations and/or collect evidence necessary to successfully prosecute violators.

Violation investigation

Inspectors can include representatives from state agencies, federally recognized tribes, and EPA regional offices. They may conduct inspections that are routine or “for cause,” which means they are the result of a complaint or tip. Inspectors may investigate retail establishments or pesticide dealers to see if products for sale are legal. They may also investigate use sites, such as farms, to see if misuse has occurred or if standards and labeling requirements for worker protection have been violated.

Laboratory analysis

If the investigation involves physical samples, the inspector collects those samples and submits them to a laboratory for analysis. A laboratory analyst:

  • Verifies formulation of samples.
  • May perform antimicrobial efficacy testing on samples.

Case development

To determine whether a violation has taken place, a case developer (or attorney) develops a case following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Enforcement Response Policy, as well as the administrative procedures set forth in the regulations. The case developer:

  • Reviews the inspector’s report.
  • Reviews the evidence.
  • Performs a word-for-word comparison of the accepted label and the label collected during the inspection.
  • May send an Enforcement Case Review (ECR) to the Office of Enforcement and Compliance Assurance (OECA) and Office of Pesticide Programs (OPP) to build a case. ECRs often include label interpretation questions.

If a problem is uncovered during the label review phase, a pesticide manufacturer or distributor can have a serious issue. Label problems can affect thousands of products or millions of units of one product already in the marketplace.

Language must be enforceable

Because the label is the law, imprecise or vague language can make a label misleading and unenforceable. If the label is not enforceable, then users who misuse a pesticide may not be prosecuted, and victims of a product’s misuse might not be compensated.

Pesticide registration

  • 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.
  • Determine if a fee is required and, if so, identify the amount and pay the fee when submitting the application.

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. 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 40 CFR 152.30.

Under the registration review process, 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.

Summary of requirements

  • Understand the exclusions and exemptions at 40 CFR 152.
  • Obtain an EPA Company Number before registering the 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 a pesticide producer who plans to register its 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 submitting the 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 acknowledgment; 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 a product is to be marketed.
  • 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.)

Company and establishment numbers

  • A “company number” is a unique identifier assigned to a company that wishes to register a pesticide with the EPA.
  • Registrants must obtain a company number prior to registering their first product with EPA.

A “company number” is a unique identifier assigned to a company that wishes to register a pesticide (e.g., herbicide, rodenticide, or antimicrobial) with the Environmental Protection Agency (EPA). A company number is also necessary for a company that plans to produce pesticides or devices. Such production requires the company to obtain a “Pesticide-Producing or Device-Producing Establishment Number.” The company number is part of the establishment number.

How to obtain an EPA company number

Registrants must obtain a company number prior to registering their first product with EPA. For subsequent products or amendment to existing registrations, the registrant must refer to this company number. (Note: Registrants who plan to produce their own products will also need to obtain an “establishment number.”)

The registrant must submit a signed letter on company letterhead to request a company number and establish an official address with EPA as described in the agency’s guidance, “How to Obtain a Company Number and Register an Official Address.” EPA will direct all future correspondence to the official address. The registrant must keep this official address record up to date.

In its request for a company number, a foreign company must designate a U.S. agent to receive correspondence and represent it in matters concerning an application. A U.S. registrant may also designate an agent. The letter should include a statement authorizing the agent to act in all matters concerning the registration of the product with EPA. It should also include a statement acknowledging that all official correspondence from EPA will be directed to the agent.

The request for a new company number can be made via email with the signed letter on company letterhead (including all needed information) as an attachment.

How to obtain an EPA establishment number

When producing or formulating a pesticide, it is necessary to register the place or facility where the pesticide or device will be produced. To register an establishment, EPA Form 3540-8, Application for Registration of Pesticide-Producing Establishments must be completed and submitted to EPA as follows:

  • For domestic establishments, the completed application should be sent to the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. The instructions for Form 3540-8 list the Regional Offices’ mailing addresses and telephone contacts.
  • For foreign establishments, applications should be submitted to EPA headquarters at the address listed in the instructions on how to properly complete Form 3540-8.

To request termination of a pesticide-producing or device-producing establishment, domestic establishments should notify the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. Foreign establishments should notify the EPA Headquarters Office listed in the instructions for Registering Establishments on the EPA website.

Registration application overview

  • Companies must submit an application for a registration action.

Companies must submit an application for a registration action, such as to register a new pesticide active ingredient, new product for an existing pesticide, or a new use for an existing product.

The company’s application typically includes:

  • A service fee;
  • Forms describing the requested action;
  • The identity and quantity of all chemicals in the product;
  • Data on potential risks to human health and the environment, including about the potential for pesticide residues on food (if applicable);
  • Proof that the product manufacturing process is reliable;
  • Labeling, including directions for use, contents, and appropriate warnings; and
  • Evidence of meeting all legal and financial obligations.

EPA publishes a notice of receipt in the Federal Register for each application for registration of a new product that contains a new pesticide active ingredient or that proposes a new use for an existing pesticide.

Applications are assigned to the appropriate pesticide division, where it is processed and tracked. An agency project manager is then assigned to:

  • Complete a detailed review of the application;
  • Assign and coordinate the appropriate scientific review;
  • Implement priorities and timetable as set by law;
  • Coordinate administrative action; and
  • Communicate with the applicant, otherwise known as the registrant, about the review.

Registration procedures

  • A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package.
  • EPA welcomes requests for a pre-registration meeting.
  • PR Notice 11-3 discusses both the recommended and the required procedures for submitting FIFRA data.

Procedures for submitting a complete application for registration of a pesticide product are detailed in regulations at 40 CFR 152.40 to 152.55. The Environmental Protection Agency (EPA) has also published the Pesticide Registration Manual as a resource for companies and individuals who want to have their pesticide products registered for sale in the United States. Detailed information for pesticide registrants (i.e., the company or individual applying to register a pesticide) concerning their responsibilities before, during, and after the review process is included in the manual, which can be found on the agency’s website.

A separate application for registration must be made for each pesticide product that will be distributed or sold. A pesticide product registration is required for each manufacturing use product or end use formulation.

Note: EPA has classified some or all of the uses of certain pesticides as “Restricted Use.” The “Restricted Use” classification restricts a product, or its uses, to use by a certified pesticide applicator or under the direct supervision of a certified applicator. Criteria used for determining whether a product requires the restricted use classification can be found in 40 CFR 152.170.

Cover letter

A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package. It should also contain the email address of the applicant in order to receive registration milestone tracking emails.

Application form

Complete and submit an original Application for Pesticide Registration/Amendment Form (EPA Form 8570-1) with each application for registration. When EPA receives the application (and the applicable fee required), the agency will screen the application during a 21-day period to determine if it contains all required forms, labeling, and data formatted as described in the agency’s guidance in Pesticide Registration (PR) Notice 11-3, as well as documentation of fee payment.

The fee payment documentation may include a request for a fee reduction or waiver or an exemption. Any deficiencies identified during the 21-day screening that are not corrected by the applicant may lead to the agency’s rejection of the application. EPA will keep 25 percent of the fee.

Pre-registration meeting

EPA welcomes requests for a pre-registration meeting. This type of meeting can provide useful guidance to the applicant regarding information needed for registration. Applicants are encouraged to contact the appropriate branch assigned to the active ingredient in their product before submitting an application for registration. Contact the ombudsman for the division if the appropriate branch is unknown.

Pesticide Registration (PR) Notice 11-3

PR Notice 11-3 discusses both the recommended and required procedures for submitting Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data. All required procedures contained within the document, generally indicated by use of the word “must,” were previously made mandatory by statute or regulation. Where indicated by the use of non-mandatory language such as “may,” “should” and “can,” EPA provides recommendations or guidance.

The PR Notice applies to all data that are submitted to EPA to support any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:

  • Application for registration or amended registration of a pesticide product under FIFRA 3 or 24.
  • Submission of data required in conjunction with reregistration of a currently registered product under FIFRA 4 (or its registration review under FIFRA 3).
  • Application for an experimental use permit under FIFRA 5.
  • Submission of data in response to a notice issued by EPA under FIFRA 3(c)(2)(B).
  • Petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under Federal Food, Drug and Cosmetic Act (FFDCA) 408.
  • Studies submitted under FIFRA 6(a)(2).

Electronic submissions

Applications for pesticide registration can now be submitted electronically to EPA. Forms, studies, and draft product labeling may all be submitted via the Pesticide Submission Portal (PSP) which is accessed through EPA’s Central Data Exchange (CDX) Network (user registration is required). Application materials, tools, and resources for submission are all available on EPA’s website. Registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools based on EPA’s XML guidance may use the PSP and forego the costs of sending physical copies to EPA.

Note that applicants do not need to submit multiple electronic copies of any pieces of their applications. In PR Notice 2011-3, EPA made clear that the requirement to submit multiple copies of data is applicable only to paper submissions and, similarly, EPA interprets the requirement to submit five copies of draft labeling in 40 CFR 152.50(e) to apply only to applications made on paper. Since electronic submissions are easily reproducible, EPA will accept electronic applications containing one copy of all the required elements.

Registration fees

  • A fee (or a waiver from paying the fee) is required for certain types of actions.
  • Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.
  • All registrations are subject to an annual maintenance fee.

The Environmental Protection Agency (EPA) keeps a fee schedule current on its Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) webpage. This is the first stop for determining the application fee amount.

A fee (or a waiver from paying the fee) is required for the following types of actions:

  • New active ingredients;
  • New uses;
  • New products;
  • Certain tolerances;
  • Certain amendments;
  • Certain inert ingredients;
  • Certain combination products;
  • Cancer reassessments and certain ecological/endangered species assessments;
  • Manufacturing use products (MUPS);
  • Experimental use permits (EUPS);
  • Human study protocols and completed studies that require review by the human studies review board;
  • Certain covered actions that require external review by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) science advisory panel;
  • Gold Seal letters; and
  • Data extension requests.

FIFRA 33(b)(2)(F) directs the agency to reject any application submitted without the required registration service fee. Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.

A certification of payment should be the first page of the submission or application and precede a cover letter or fee waiver or reduction request to enable the agency to match a payment with an application.

To help applicants identify the appropriate fee and pay it in advance of submitting an application (pre-payment) or upon submission to EPA, the “Fee Determination Decision Tree” is available on the agency website. Through a series of questions and answers, pesticide registration applicants are led to the appropriate fee category and fee.

Also, chapter 5 of the Pesticide Registration Manual offers in-depth information about registration fees.

Annual pesticide registration maintenance fees

All registrations are subject to an annual maintenance fee. Affected applicants will be contacted by mail in November with instructions for submitting the fee, which is due by the fifteenth of January. No extensions of this due date are possible. The amount of the per product fee will vary from year to year as the fee is dependent upon the projected number of products for which registrants will pay this fee.

Although there are procedures for requesting a fee waiver for individual products, maintenance fees will be reduced by 25 percent for the first registration only, if the applicant can show that:

  • The applicant has 500 or fewer employees globally,
  • During the three-year period prior to the most recent maintenance fee billing cycle the applicant has average annual gross revenue from all sources that do not exceed $10,000,000, and
  • The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet certain narrow criteria in two categories: minor agricultural use products and public health pesticides.

EPA assessment

  • EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use are necessary to protect the environment.
  • EPA uses a four-step process for its human health risk assessments.
  • As a final step of evaluation, EPA implements an overall risk assessment and peer review.

The Environmental Protection Agency (EPA) evaluates new pesticides before they can enter the market and re-evaluates existing pesticides to ensure they continue to meet appropriate safety standards.

Ecological risk assessment

EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use or proposed use are necessary to protect the environment. Many plant and wildlife species can be found near or in cities, agricultural fields, and recreational areas. Before allowing a pesticide product to be sold on the market, EPA ensures that the pesticide will not pose any unreasonable risks to plants, wildlife, and the environment. This is done in phases:

  • Planning phase: Planning and scoping process — EPA begins the process of ecological risk assessment with planning and research.
  • Phase 1: Problem formulation — Information is gathered to help determine what plants and animals are at risk and need to be protected.
  • Phase 2: Analysis — This is the determination of what plants and animals are exposed and to what degree they are exposed, and whether or not that level of exposure is likely to cause harmful ecological effects.
  • Phase 3: Risk characterization — Risk characterization includes two major components (risk estimation and risk description). Risk estimation combines exposure profiles (i.e., the findings of exposure characterization) and effects from exposure. Risk description provides information important for interpreting the risk results and identifies a level for harmful effects on the plants and animals of concern.

Human risk assessment

A human health risk assessment is the process to estimate the nature and probability of adverse health effects in humans who may be exposed to chemicals in contaminated environmental media, now or in the future. Human health risk assessments address questions such as:

  • What types of health problems are caused by pesticides in the environment?
  • What is the chance that people will experience problems when exposed to different levels of pesticides?
  • Is there a low level below which some chemicals don’t pose a human health risk?
  • What pesticides are people exposed to and for how long?
  • Are legal limits for pesticide residues in food (tolerances or maximum residue limits) protective of human health?
  • Are people more likely to be susceptible or exposed to pesticides because of factors such as age, genetics, pre-existing health conditions, ethnicity, gender, where they work, where they play, what they eat, etc.

EPA uses the National Research Council’s four-step process for its human health risk assessments:

  1. Hazard identification examines whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances.
  2. Dose response assessment examines the numerical relationship between exposure and effects.
  3. Exposure assessment examines what is known about the frequency, timing, and levels of contact with a substance.
  4. Risk characterization examines how well the data support conclusions about the nature and extent of the risk from exposure to pesticides.

Cumulative risk assessment

The Food Quality Protection Act of 1996 requires EPA to also conduct a cumulative risk assessment for pesticides that have a common mechanism of toxicity. A common mechanism of toxicity is identified when two or more chemicals or other substances cause a common toxic effect(s) by the same, or essentially the same, sequence of major biochemical events.

Final assessment and review

As a final step of evaluation, EPA implements an overall risk assessment and peer review. The agency reviews all the scientific data on the pesticide product and develops comprehensive risk assessments that examine the potential effects of the product or ingredients on the human population and environment. Health and environmental risk assessments undergo a process of peer review by scientific experts.

EPA risk management and regulatory decisions

  • After completing its risk assessments and peer review, EPA makes risk management and regulatory decisions.

After completing its risk assessments and peer review, the Environmental Protection Agency (EPA) makes risk management and regulatory decisions to:

  • Consider the results of the risk assessments and the peer review;
  • Research alternative pesticides that are already registered;
  • Review any measures needed to mitigate any identified risks;
  • Discuss with the applicant if modifications to the product or labeling must be made to mitigate risk;
  • Establish new food tolerances if needed, after publishing notices for comment in the Federal Register;
  • Reject or grant the registration; and
  • Publish in the Federal Register a notice of issuance of the registration, if granted.

Required initial/annual reporting

For new establishments, an initial report must be submitted no later than 30 days after the first registration of each establishment. The records that must be maintained and the retention period are described in 40 CFR 169.

All active establishments are required to submit an annual production report on Environmental Protection Agency (EPA) Form 3540-16, Pesticide Report for Pesticide-Producing Establishments by March 1 of each year to the appropriate EPA Regional Office listed in the “Instructions for Completing EPA Form 3540-16.”

Company and establishment numbers

  • A “company number” is a unique identifier assigned to a company that wishes to register a pesticide with the EPA.
  • Registrants must obtain a company number prior to registering their first product with EPA.

A “company number” is a unique identifier assigned to a company that wishes to register a pesticide (e.g., herbicide, rodenticide, or antimicrobial) with the Environmental Protection Agency (EPA). A company number is also necessary for a company that plans to produce pesticides or devices. Such production requires the company to obtain a “Pesticide-Producing or Device-Producing Establishment Number.” The company number is part of the establishment number.

How to obtain an EPA company number

Registrants must obtain a company number prior to registering their first product with EPA. For subsequent products or amendment to existing registrations, the registrant must refer to this company number. (Note: Registrants who plan to produce their own products will also need to obtain an “establishment number.”)

The registrant must submit a signed letter on company letterhead to request a company number and establish an official address with EPA as described in the agency’s guidance, “How to Obtain a Company Number and Register an Official Address.” EPA will direct all future correspondence to the official address. The registrant must keep this official address record up to date.

In its request for a company number, a foreign company must designate a U.S. agent to receive correspondence and represent it in matters concerning an application. A U.S. registrant may also designate an agent. The letter should include a statement authorizing the agent to act in all matters concerning the registration of the product with EPA. It should also include a statement acknowledging that all official correspondence from EPA will be directed to the agent.

The request for a new company number can be made via email with the signed letter on company letterhead (including all needed information) as an attachment.

How to obtain an EPA establishment number

When producing or formulating a pesticide, it is necessary to register the place or facility where the pesticide or device will be produced. To register an establishment, EPA Form 3540-8, Application for Registration of Pesticide-Producing Establishments must be completed and submitted to EPA as follows:

  • For domestic establishments, the completed application should be sent to the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. The instructions for Form 3540-8 list the Regional Offices’ mailing addresses and telephone contacts.
  • For foreign establishments, applications should be submitted to EPA headquarters at the address listed in the instructions on how to properly complete Form 3540-8.

To request termination of a pesticide-producing or device-producing establishment, domestic establishments should notify the EPA Regional Office having jurisdiction over the state in which the company headquarters is located. Foreign establishments should notify the EPA Headquarters Office listed in the instructions for Registering Establishments on the EPA website.

Registration application overview

  • Companies must submit an application for a registration action.

Companies must submit an application for a registration action, such as to register a new pesticide active ingredient, new product for an existing pesticide, or a new use for an existing product.

The company’s application typically includes:

  • A service fee;
  • Forms describing the requested action;
  • The identity and quantity of all chemicals in the product;
  • Data on potential risks to human health and the environment, including about the potential for pesticide residues on food (if applicable);
  • Proof that the product manufacturing process is reliable;
  • Labeling, including directions for use, contents, and appropriate warnings; and
  • Evidence of meeting all legal and financial obligations.

EPA publishes a notice of receipt in the Federal Register for each application for registration of a new product that contains a new pesticide active ingredient or that proposes a new use for an existing pesticide.

Applications are assigned to the appropriate pesticide division, where it is processed and tracked. An agency project manager is then assigned to:

  • Complete a detailed review of the application;
  • Assign and coordinate the appropriate scientific review;
  • Implement priorities and timetable as set by law;
  • Coordinate administrative action; and
  • Communicate with the applicant, otherwise known as the registrant, about the review.

Registration procedures

  • A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package.
  • EPA welcomes requests for a pre-registration meeting.
  • PR Notice 11-3 discusses both the recommended and the required procedures for submitting FIFRA data.

Procedures for submitting a complete application for registration of a pesticide product are detailed in regulations at 40 CFR 152.40 to 152.55. The Environmental Protection Agency (EPA) has also published the Pesticide Registration Manual as a resource for companies and individuals who want to have their pesticide products registered for sale in the United States. Detailed information for pesticide registrants (i.e., the company or individual applying to register a pesticide) concerning their responsibilities before, during, and after the review process is included in the manual, which can be found on the agency’s website.

A separate application for registration must be made for each pesticide product that will be distributed or sold. A pesticide product registration is required for each manufacturing use product or end use formulation.

Note: EPA has classified some or all of the uses of certain pesticides as “Restricted Use.” The “Restricted Use” classification restricts a product, or its uses, to use by a certified pesticide applicator or under the direct supervision of a certified applicator. Criteria used for determining whether a product requires the restricted use classification can be found in 40 CFR 152.170.

Cover letter

A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package. It should also contain the email address of the applicant in order to receive registration milestone tracking emails.

Application form

Complete and submit an original Application for Pesticide Registration/Amendment Form (EPA Form 8570-1) with each application for registration. When EPA receives the application (and the applicable fee required), the agency will screen the application during a 21-day period to determine if it contains all required forms, labeling, and data formatted as described in the agency’s guidance in Pesticide Registration (PR) Notice 11-3, as well as documentation of fee payment.

The fee payment documentation may include a request for a fee reduction or waiver or an exemption. Any deficiencies identified during the 21-day screening that are not corrected by the applicant may lead to the agency’s rejection of the application. EPA will keep 25 percent of the fee.

Pre-registration meeting

EPA welcomes requests for a pre-registration meeting. This type of meeting can provide useful guidance to the applicant regarding information needed for registration. Applicants are encouraged to contact the appropriate branch assigned to the active ingredient in their product before submitting an application for registration. Contact the ombudsman for the division if the appropriate branch is unknown.

Pesticide Registration (PR) Notice 11-3

PR Notice 11-3 discusses both the recommended and required procedures for submitting Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data. All required procedures contained within the document, generally indicated by use of the word “must,” were previously made mandatory by statute or regulation. Where indicated by the use of non-mandatory language such as “may,” “should” and “can,” EPA provides recommendations or guidance.

The PR Notice applies to all data that are submitted to EPA to support any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:

  • Application for registration or amended registration of a pesticide product under FIFRA 3 or 24.
  • Submission of data required in conjunction with reregistration of a currently registered product under FIFRA 4 (or its registration review under FIFRA 3).
  • Application for an experimental use permit under FIFRA 5.
  • Submission of data in response to a notice issued by EPA under FIFRA 3(c)(2)(B).
  • Petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under Federal Food, Drug and Cosmetic Act (FFDCA) 408.
  • Studies submitted under FIFRA 6(a)(2).

Electronic submissions

Applications for pesticide registration can now be submitted electronically to EPA. Forms, studies, and draft product labeling may all be submitted via the Pesticide Submission Portal (PSP) which is accessed through EPA’s Central Data Exchange (CDX) Network (user registration is required). Application materials, tools, and resources for submission are all available on EPA’s website. Registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools based on EPA’s XML guidance may use the PSP and forego the costs of sending physical copies to EPA.

Note that applicants do not need to submit multiple electronic copies of any pieces of their applications. In PR Notice 2011-3, EPA made clear that the requirement to submit multiple copies of data is applicable only to paper submissions and, similarly, EPA interprets the requirement to submit five copies of draft labeling in 40 CFR 152.50(e) to apply only to applications made on paper. Since electronic submissions are easily reproducible, EPA will accept electronic applications containing one copy of all the required elements.

Registration fees

  • A fee (or a waiver from paying the fee) is required for certain types of actions.
  • Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.
  • All registrations are subject to an annual maintenance fee.

The Environmental Protection Agency (EPA) keeps a fee schedule current on its Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) webpage. This is the first stop for determining the application fee amount.

A fee (or a waiver from paying the fee) is required for the following types of actions:

  • New active ingredients;
  • New uses;
  • New products;
  • Certain tolerances;
  • Certain amendments;
  • Certain inert ingredients;
  • Certain combination products;
  • Cancer reassessments and certain ecological/endangered species assessments;
  • Manufacturing use products (MUPS);
  • Experimental use permits (EUPS);
  • Human study protocols and completed studies that require review by the human studies review board;
  • Certain covered actions that require external review by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) science advisory panel;
  • Gold Seal letters; and
  • Data extension requests.

FIFRA 33(b)(2)(F) directs the agency to reject any application submitted without the required registration service fee. Twenty-five percent of the fee is non-refundable once an application is submitted, even if it is rejected.

A certification of payment should be the first page of the submission or application and precede a cover letter or fee waiver or reduction request to enable the agency to match a payment with an application.

To help applicants identify the appropriate fee and pay it in advance of submitting an application (pre-payment) or upon submission to EPA, the “Fee Determination Decision Tree” is available on the agency website. Through a series of questions and answers, pesticide registration applicants are led to the appropriate fee category and fee.

Also, chapter 5 of the Pesticide Registration Manual offers in-depth information about registration fees.

Annual pesticide registration maintenance fees

All registrations are subject to an annual maintenance fee. Affected applicants will be contacted by mail in November with instructions for submitting the fee, which is due by the fifteenth of January. No extensions of this due date are possible. The amount of the per product fee will vary from year to year as the fee is dependent upon the projected number of products for which registrants will pay this fee.

Although there are procedures for requesting a fee waiver for individual products, maintenance fees will be reduced by 25 percent for the first registration only, if the applicant can show that:

  • The applicant has 500 or fewer employees globally,
  • During the three-year period prior to the most recent maintenance fee billing cycle the applicant has average annual gross revenue from all sources that do not exceed $10,000,000, and
  • The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet certain narrow criteria in two categories: minor agricultural use products and public health pesticides.

EPA assessment

  • EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use are necessary to protect the environment.
  • EPA uses a four-step process for its human health risk assessments.
  • As a final step of evaluation, EPA implements an overall risk assessment and peer review.

The Environmental Protection Agency (EPA) evaluates new pesticides before they can enter the market and re-evaluates existing pesticides to ensure they continue to meet appropriate safety standards.

Ecological risk assessment

EPA conducts ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use or proposed use are necessary to protect the environment. Many plant and wildlife species can be found near or in cities, agricultural fields, and recreational areas. Before allowing a pesticide product to be sold on the market, EPA ensures that the pesticide will not pose any unreasonable risks to plants, wildlife, and the environment. This is done in phases:

  • Planning phase: Planning and scoping process — EPA begins the process of ecological risk assessment with planning and research.
  • Phase 1: Problem formulation — Information is gathered to help determine what plants and animals are at risk and need to be protected.
  • Phase 2: Analysis — This is the determination of what plants and animals are exposed and to what degree they are exposed, and whether or not that level of exposure is likely to cause harmful ecological effects.
  • Phase 3: Risk characterization — Risk characterization includes two major components (risk estimation and risk description). Risk estimation combines exposure profiles (i.e., the findings of exposure characterization) and effects from exposure. Risk description provides information important for interpreting the risk results and identifies a level for harmful effects on the plants and animals of concern.

Human risk assessment

A human health risk assessment is the process to estimate the nature and probability of adverse health effects in humans who may be exposed to chemicals in contaminated environmental media, now or in the future. Human health risk assessments address questions such as:

  • What types of health problems are caused by pesticides in the environment?
  • What is the chance that people will experience problems when exposed to different levels of pesticides?
  • Is there a low level below which some chemicals don’t pose a human health risk?
  • What pesticides are people exposed to and for how long?
  • Are legal limits for pesticide residues in food (tolerances or maximum residue limits) protective of human health?
  • Are people more likely to be susceptible or exposed to pesticides because of factors such as age, genetics, pre-existing health conditions, ethnicity, gender, where they work, where they play, what they eat, etc.

EPA uses the National Research Council’s four-step process for its human health risk assessments:

  1. Hazard identification examines whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances.
  2. Dose response assessment examines the numerical relationship between exposure and effects.
  3. Exposure assessment examines what is known about the frequency, timing, and levels of contact with a substance.
  4. Risk characterization examines how well the data support conclusions about the nature and extent of the risk from exposure to pesticides.

Cumulative risk assessment

The Food Quality Protection Act of 1996 requires EPA to also conduct a cumulative risk assessment for pesticides that have a common mechanism of toxicity. A common mechanism of toxicity is identified when two or more chemicals or other substances cause a common toxic effect(s) by the same, or essentially the same, sequence of major biochemical events.

Final assessment and review

As a final step of evaluation, EPA implements an overall risk assessment and peer review. The agency reviews all the scientific data on the pesticide product and develops comprehensive risk assessments that examine the potential effects of the product or ingredients on the human population and environment. Health and environmental risk assessments undergo a process of peer review by scientific experts.

EPA risk management and regulatory decisions

  • After completing its risk assessments and peer review, EPA makes risk management and regulatory decisions.

After completing its risk assessments and peer review, the Environmental Protection Agency (EPA) makes risk management and regulatory decisions to:

  • Consider the results of the risk assessments and the peer review;
  • Research alternative pesticides that are already registered;
  • Review any measures needed to mitigate any identified risks;
  • Discuss with the applicant if modifications to the product or labeling must be made to mitigate risk;
  • Establish new food tolerances if needed, after publishing notices for comment in the Federal Register;
  • Reject or grant the registration; and
  • Publish in the Federal Register a notice of issuance of the registration, if granted.

Required initial/annual reporting

For new establishments, an initial report must be submitted no later than 30 days after the first registration of each establishment. The records that must be maintained and the retention period are described in 40 CFR 169.

All active establishments are required to submit an annual production report on Environmental Protection Agency (EPA) Form 3540-16, Pesticide Report for Pesticide-Producing Establishments by March 1 of each year to the appropriate EPA Regional Office listed in the “Instructions for Completing EPA Form 3540-16.”

Pesticide labels and labeling

  • Unlike most other types of product labels, pesticide labels are legally enforceable.

Pesticide product labels and labeling provide critical information about how to safely and legally handle and use pesticide products. A pesticide product’s label and labeling are of utmost importance as they are the primary mechanism to inform the end-user about how to use and apply the product to achieve the product’s useful functions, as well as which precautions must be followed to protect both human health and the environment.

Label versus labeling

A pesticide “label” includes any text or images printed directly on, or attached to, the product or its packaging. “Labeling,” on the other hand, includes the label, as well as any printed or written material that accompanies the product (for example, a booklet). Labeling can also include material to which the label (or other labeling material) refers. For instance, if a label refers to a manual on how to conduct a procedure, that manual is also labeling that the user must follow and the Environmental Protection Agency (EPA) must review and approve before the product may be sold or distributed.

The label is the law

Every pesticide product must bear a label containing the information specified by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S. Code section 136 et seq., and its implementing regulations at 40 CFR 156. FIFRA and Part 156 govern what must be included on pesticide labels.

Unlike most other types of product labels, pesticide labels and labeling are legally enforceable, and all of them carry the statement: “It is a violation of federal law to use this product in a manner inconsistent with its labeling.” One could say, “The label is the law.” Enforcement of pesticide regulations and label requirements is primarily carried out by state agencies acting under cooperative agreements with EPA.

Label review and approval

As part of any pesticide registration application submitted to EPA, applicants must provide a proposed label containing detailed information. The agency ensures that the pesticide label translates scientific data about the potential health and environmental effects of a pesticide into a set of conditions, directions, precautions, and restrictions that define who may use a pesticide, as well as where, how, how much, and how often it may be used.

During its review, EPA may approve the label as submitted, approve the label with comments, or disapprove the submitted label. The label must be approved before a pesticide can be sold or distributed in the United States.

Ultimately, the accuracy of a label is vital as it may impact:

  • EPA and other agencies that use the label to manage and mitigate pesticide risks;
  • EPA and other agencies that enforce pesticide production, distribution, and use;
  • Registrants, including pesticide manufacturers, and their supplemental distributors;
  • Pesticide applicators who rely on the label for hazard and safety information and use directions to ensure safe and effective use;
  • Bystanders and other individuals who may be exposed to the pesticide; and
  • Courts that consider a label to be a legal document.

Summary of requirements

  • Determine whether the product is or is not a pesticide. See 40 CFR 152.
  • Determine whether the product is exempted from FIFRA. See 40 CFR 152.
  • Determine whether the pesticide product is exempted from registration. See 40 CFR 152.
  • If the pesticide product is unregistered and non-exempt, then it is not exempted from registration:
    • Develop draft labeling that meets the Part 156 requirements, including for content and format.
    • Follow the application procedures at 152.50 for submitting applications and draft labeling. Submit five copies of the proposed draft labeling with an application. The draft labeling may be typed or otherwise printed but must be legible, reproducible, and on 8-1/2 x 11-inch paper. However, EPA encourages electronic submission. See the EPA Electronic Submission of Labels webpage for information.
    • EPA will review draft labeling submitted with the application and can approve the label as submitted, approve the label with comments, or disapprove the submitted label.
    • Once EPA has granted a registration, EPA not only notifies the registrant of the decision but also will approve a submitted label for the product.
    • Include an approved label on every package on all registered products.
    • Do not alter or change the label after the registration approval. If the product was previously registered with EPA and a change to the registration, such as a change to the labeling text, is needed, file an application to amend the registered product.
    • Do not sell or distribute a pesticide if any claims made for it differ from the claims made on labeling required for registration. (Advertising claims for a pesticide product must not contradict claims made in the product’s labeling.)
  • Ensure that supplemental distributor products and their distributor labeling comply with 152.132. Distributor labels are not submitted for approval, but a Notice of Supplemental Distribution must be submitted to EPA before supplemental distribution of the product. A distributor label must be the same as that of the registered product label with some important exceptions.

Guidance

Given the high importance of labels in pesticide management, application, and regulatory enforcement, EPA has compiled a comprehensive Label Review Manual (LRM), which is available on the agency website. This instructional aid compiles existing interpretations of statutory and regulatory provisions and reiterates existing agency policies. The LRM also provides assistance and insight into how pesticide labels should generally be drafted.

Further regulatory guidance may be found in EPA Pesticide Registration Notices (PR Notices or PRN).

Types of labels/labeling

  • Master label, sub-label, supplemental distributor labeling, and supplemental labeling are the four types of pesticide labels and labeling.

There are four types of pesticide labels and labeling:

  • Master label,
  • Sub-label (split-label),
  • Supplemental distributor labeling, and
  • Supplemental labeling.

Master label

The master label displays the claims and directions for the approved uses of a given product and all associated required labeling. All other labeling for the product must not contain any text beyond that which is approved in the master label (with the exception of the supplemental label).

This label is filed with the Environmental Protection Agency (EPA) once it is stamped “accepted.”

Sub-label (split-label)

A sub-label or split-label displays the claims and directions for only a portion of the approved uses under a given master label. The label is complete, listing all of the required label elements, but the company may want the label displayed differently for marketing purposes. EPA allows registrants to distribute or sell a product under a sub-label or split-label provided that no changes would be necessary to the precautionary statements, use classification, or packaging of the product.

A sub-label or split-label only contains labeling text that also appears on the master label. When a sub-label is submitted with additions not on the accepted master label, a new master label containing all the uses currently approved under the product’s registration is required. Only the master label will be stamped “accepted.”

Supplemental distributor labeling

Supplemental distributor labeling includes labels for a product that is registered to one company but distributed by another company (sometimes referred to as a “sub-registrant”) under that company’s name. These labels must be the same as the labels for the registered product, with the following exceptions:

  • Product name
  • Name and address
  • Registration number (EPA Reg. No. xxxx-xx-xxxx, where the third set of numbers refers to the distributor’s company number)
  • Establishment

In addition, claims may be deleted, but new claims that differ from the parent label cannot be added to a distributor label.

The parent company must notify EPA before distribution by submitting a Notice of Supplemental Distribution (EPA Form 8570-5).

EPA does not receive or review supplemental distributor labeling, but EPA can review the distributor company names to ensure that they are not misleading. The parent company is responsible for ensuring that the supplemental distributor is in compliance with these requirements.

Supplemental labeling

Supplemental labeling includes labels that contain newly approved uses, use directions, or other instructions that have been added since the last accepted master label. These new uses and directions are incorporated into the EPA master label, but because they are not on those products already in the channels of trade, they are distributed with the product by the registrant or distributors.

These are partial labels, so they must include a statement referring the user to the product label for complete directions and precautions, and a statement that the labeling must be in the possession of the user. The user must follow the supplemental label, the product’s container label, and all other labeling that comes with the product in order to apply it in a way that reduces risk and maximizes efficacy.

The supplemental labeling must be submitted and stamped “accepted” by EPA prior to distribution. EPA requires that these labels include the following information:

  • Product name
  • EPA registration number
  • Restricted use classification statement (if applicable)
  • “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”
  • “The labeling must be in possession of the user at the time of application.”
  • “Read the label affixed to the container for [product name] before applying.”
  • “Use of [product name] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [product name].”

Normally, supplemental labeling will be incorporated into the affixed label at the next printing of the product label or within 18 months. The agency recommends an expiration date of 18 months after acceptance on supplemental labels. However, this might not be done in all cases, such as if the directions for use are subject to continual, frequent change.

Labels that require review

  • Various types of labels require EPA review, as discussed here.

Labels for products containing new active ingredients and/or new uses — This type of submission involves a new active ingredient that is currently not registered by the Environmental Protection Agency (EPA) as a pesticide or a new use of an existing product.

Labels for new products containing existing active ingredients — This type of submission involves an application for registration of a product containing an active ingredient that is currently registered for use as a pesticide in other products.

Labels for technical grade and manufacturing use products — This type of submission involves a product that is used to manufacture or formulate other pesticides.

Labels for products requiring amendments — This type of submission involves an application for an amendment to a currently registered pesticide. There are two kinds of amendment submissions:

  • No data review required. An example is an amendment for the addition to the label of a new site or pest that has been previously approved by EPA for other products containing the same active ingredient. For products composed of multiple active ingredients, the proposed new site or pest must be previously approved for all of the active ingredients.
  • Data review required. An example is an amendment involving a new use, a new application rate, or a change in precautionary statements. This is an action not previously approved by EPA, and a data submission and review are necessary. Review of the label will be based on the conclusions of the data reviews from the product chemists, toxicologists, or efficacy reviewers. Generally, the specific reviews will only affect a small portion of the label; the rest of the text should remain unchanged from the originally accepted label.

Fast track labels — This type of submission involves no data or only product chemistry data.

Me-too registration labels — This type of submission involves a pesticide product and proposed use that is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.

Labels for products with efficacy data requirements — This type of submission involves products for which efficacy data is required. Efficacy studies document how well pesticide products perform as pest control agents. Even though registrants/applicants must conduct efficacy studies, the agency only routinely requires the submission of these studies for certain types of products. EPA reviews efficacy data (also referred to as product performance data) when a pesticide product bears a claim to control pest organisms that pose a threat to human health. Such pests include, but are not limited to:

  • Microorganisms that are infectious to humans in any area of the inanimate environment;
  • Vertebrates (e.g., rodents, birds, bats, and skunks) that may directly or indirectly transmit diseases to or injure humans; or
  • Insects that carry human diseases (e.g., mosquitoes and ticks).

Public health pests are listed in Pesticide Registration (PR) Notice 2002-1. EPA also requires submission of efficacy data to support claims for the control of termites. On a case-by-case basis, the agency may require substantiation of an efficacy claim.

Labels for special local need (SLN) products — This type of submission involves products for which particular states register additional uses to meet their specific needs. Such registrations are for distribution and use only within a particular state to meet an SLN. Unlike other labels, EPA does not actively accept SLN labels. Instead, EPA has 90 days to disapprove it; otherwise, it is considered an accepted label under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Experimental use permits — Experimental use permits authorize testing (across an area greater than 10 acres of land or one acre of water) of unregistered pesticides or registered pesticides’ unregistered uses.

Labels that do not require review

  • With supplemental distributor labeling, EPA reviews the parent company’s labeling, but not the distributor’s labeling.
  • Certain types of products are exempt from FIFRA because EPA determined them to be adequately regulated by another federal agency or of a character that is unnecessary to be subject to FIFRA.

Supplemental distributor labeling — This type of submission involves labels for a product that is registered to one company, but distributed by another company. The Environmental Protection Agency (EPA) reviews the parent company’s labeling, but not the distributor’s labeling. Supplemental distributor products are still subject to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA can review distributor company names to ensure that they are not misleading.

Labels for products exempted from FIFRA by 40 CFR 152.20 and 152.25 — Certain types of products are exempt from FIFRA because EPA determined them to be:

  • Adequately regulated by another federal agency, or
  • Of a character that is unnecessary to be subject to FIFRA, such as insect pheromones or products containing only certain listed ingredients EPA determined to pose minimum risks.

Labels for modified products requiring notification and non-notification — This type of submission involves product modifications that do not require EPA approval. These modifications must have no potential to cause unreasonable adverse effects to the environment. Some of these modifications can be made simply by notifying EPA (known as notification). Examples include:

  • Adding or changing alternate brand names,
  • Changing primary product name, or
  • Changing symbols and graphics (except skull and crossbones).

Other modifications may be made without notifying EPA (known as non-notification). Examples include:

  • Correcting typographical and printing errors,
  • Changing package size and net contents (with some exceptions), and
  • Changing name or address of registrant.

Label compliance and enforcement

  • There are four steps in the pesticide label review and enforcement process.
  • Imprecise or vague language can make a label misleading and unenforceable.

Label review

When conducting a label review, the Environmental Protection Agency (EPA) considers:

  • Whether a user can understand and follow the label; and
  • Whether the label is clear, accurate, and consistent with EPA policy and is enforceable by the states or EPA regions.

EPA can stamp a label as “accepted,” send the label back to the manufacturer for corrections, or begin an investigation to detect violations and/or collect evidence necessary to successfully prosecute violators.

Violation investigation

Inspectors can include representatives from state agencies, federally recognized tribes, and EPA regional offices. They may conduct inspections that are routine or “for cause,” which means they are the result of a complaint or tip. Inspectors may investigate retail establishments or pesticide dealers to see if products for sale are legal. They may also investigate use sites, such as farms, to see if misuse has occurred or if standards and labeling requirements for worker protection have been violated.

Laboratory analysis

If the investigation involves physical samples, the inspector collects those samples and submits them to a laboratory for analysis. A laboratory analyst:

  • Verifies formulation of samples.
  • May perform antimicrobial efficacy testing on samples.

Case development

To determine whether a violation has taken place, a case developer (or attorney) develops a case following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Enforcement Response Policy, as well as the administrative procedures set forth in the regulations. The case developer:

  • Reviews the inspector’s report.
  • Reviews the evidence.
  • Performs a word-for-word comparison of the accepted label and the label collected during the inspection.
  • May send an Enforcement Case Review (ECR) to the Office of Enforcement and Compliance Assurance (OECA) and Office of Pesticide Programs (OPP) to build a case. ECRs often include label interpretation questions.

If a problem is uncovered during the label review phase, a pesticide manufacturer or distributor can have a serious issue. Label problems can affect thousands of products or millions of units of one product already in the marketplace.

Language must be enforceable

Because the label is the law, imprecise or vague language can make a label misleading and unenforceable. If the label is not enforceable, then users who misuse a pesticide may not be prosecuted, and victims of a product’s misuse might not be compensated.

Types of labels/labeling

  • Master label, sub-label, supplemental distributor labeling, and supplemental labeling are the four types of pesticide labels and labeling.

There are four types of pesticide labels and labeling:

  • Master label,
  • Sub-label (split-label),
  • Supplemental distributor labeling, and
  • Supplemental labeling.

Master label

The master label displays the claims and directions for the approved uses of a given product and all associated required labeling. All other labeling for the product must not contain any text beyond that which is approved in the master label (with the exception of the supplemental label).

This label is filed with the Environmental Protection Agency (EPA) once it is stamped “accepted.”

Sub-label (split-label)

A sub-label or split-label displays the claims and directions for only a portion of the approved uses under a given master label. The label is complete, listing all of the required label elements, but the company may want the label displayed differently for marketing purposes. EPA allows registrants to distribute or sell a product under a sub-label or split-label provided that no changes would be necessary to the precautionary statements, use classification, or packaging of the product.

A sub-label or split-label only contains labeling text that also appears on the master label. When a sub-label is submitted with additions not on the accepted master label, a new master label containing all the uses currently approved under the product’s registration is required. Only the master label will be stamped “accepted.”

Supplemental distributor labeling

Supplemental distributor labeling includes labels for a product that is registered to one company but distributed by another company (sometimes referred to as a “sub-registrant”) under that company’s name. These labels must be the same as the labels for the registered product, with the following exceptions:

  • Product name
  • Name and address
  • Registration number (EPA Reg. No. xxxx-xx-xxxx, where the third set of numbers refers to the distributor’s company number)
  • Establishment

In addition, claims may be deleted, but new claims that differ from the parent label cannot be added to a distributor label.

The parent company must notify EPA before distribution by submitting a Notice of Supplemental Distribution (EPA Form 8570-5).

EPA does not receive or review supplemental distributor labeling, but EPA can review the distributor company names to ensure that they are not misleading. The parent company is responsible for ensuring that the supplemental distributor is in compliance with these requirements.

Supplemental labeling

Supplemental labeling includes labels that contain newly approved uses, use directions, or other instructions that have been added since the last accepted master label. These new uses and directions are incorporated into the EPA master label, but because they are not on those products already in the channels of trade, they are distributed with the product by the registrant or distributors.

These are partial labels, so they must include a statement referring the user to the product label for complete directions and precautions, and a statement that the labeling must be in the possession of the user. The user must follow the supplemental label, the product’s container label, and all other labeling that comes with the product in order to apply it in a way that reduces risk and maximizes efficacy.

The supplemental labeling must be submitted and stamped “accepted” by EPA prior to distribution. EPA requires that these labels include the following information:

  • Product name
  • EPA registration number
  • Restricted use classification statement (if applicable)
  • “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”
  • “The labeling must be in possession of the user at the time of application.”
  • “Read the label affixed to the container for [product name] before applying.”
  • “Use of [product name] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [product name].”

Normally, supplemental labeling will be incorporated into the affixed label at the next printing of the product label or within 18 months. The agency recommends an expiration date of 18 months after acceptance on supplemental labels. However, this might not be done in all cases, such as if the directions for use are subject to continual, frequent change.

Labels that require review

  • Various types of labels require EPA review, as discussed here.

Labels for products containing new active ingredients and/or new uses — This type of submission involves a new active ingredient that is currently not registered by the Environmental Protection Agency (EPA) as a pesticide or a new use of an existing product.

Labels for new products containing existing active ingredients — This type of submission involves an application for registration of a product containing an active ingredient that is currently registered for use as a pesticide in other products.

Labels for technical grade and manufacturing use products — This type of submission involves a product that is used to manufacture or formulate other pesticides.

Labels for products requiring amendments — This type of submission involves an application for an amendment to a currently registered pesticide. There are two kinds of amendment submissions:

  • No data review required. An example is an amendment for the addition to the label of a new site or pest that has been previously approved by EPA for other products containing the same active ingredient. For products composed of multiple active ingredients, the proposed new site or pest must be previously approved for all of the active ingredients.
  • Data review required. An example is an amendment involving a new use, a new application rate, or a change in precautionary statements. This is an action not previously approved by EPA, and a data submission and review are necessary. Review of the label will be based on the conclusions of the data reviews from the product chemists, toxicologists, or efficacy reviewers. Generally, the specific reviews will only affect a small portion of the label; the rest of the text should remain unchanged from the originally accepted label.

Fast track labels — This type of submission involves no data or only product chemistry data.

Me-too registration labels — This type of submission involves a pesticide product and proposed use that is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.

Labels for products with efficacy data requirements — This type of submission involves products for which efficacy data is required. Efficacy studies document how well pesticide products perform as pest control agents. Even though registrants/applicants must conduct efficacy studies, the agency only routinely requires the submission of these studies for certain types of products. EPA reviews efficacy data (also referred to as product performance data) when a pesticide product bears a claim to control pest organisms that pose a threat to human health. Such pests include, but are not limited to:

  • Microorganisms that are infectious to humans in any area of the inanimate environment;
  • Vertebrates (e.g., rodents, birds, bats, and skunks) that may directly or indirectly transmit diseases to or injure humans; or
  • Insects that carry human diseases (e.g., mosquitoes and ticks).

Public health pests are listed in Pesticide Registration (PR) Notice 2002-1. EPA also requires submission of efficacy data to support claims for the control of termites. On a case-by-case basis, the agency may require substantiation of an efficacy claim.

Labels for special local need (SLN) products — This type of submission involves products for which particular states register additional uses to meet their specific needs. Such registrations are for distribution and use only within a particular state to meet an SLN. Unlike other labels, EPA does not actively accept SLN labels. Instead, EPA has 90 days to disapprove it; otherwise, it is considered an accepted label under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Experimental use permits — Experimental use permits authorize testing (across an area greater than 10 acres of land or one acre of water) of unregistered pesticides or registered pesticides’ unregistered uses.

Labels that do not require review

  • With supplemental distributor labeling, EPA reviews the parent company’s labeling, but not the distributor’s labeling.
  • Certain types of products are exempt from FIFRA because EPA determined them to be adequately regulated by another federal agency or of a character that is unnecessary to be subject to FIFRA.

Supplemental distributor labeling — This type of submission involves labels for a product that is registered to one company, but distributed by another company. The Environmental Protection Agency (EPA) reviews the parent company’s labeling, but not the distributor’s labeling. Supplemental distributor products are still subject to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA can review distributor company names to ensure that they are not misleading.

Labels for products exempted from FIFRA by 40 CFR 152.20 and 152.25 — Certain types of products are exempt from FIFRA because EPA determined them to be:

  • Adequately regulated by another federal agency, or
  • Of a character that is unnecessary to be subject to FIFRA, such as insect pheromones or products containing only certain listed ingredients EPA determined to pose minimum risks.

Labels for modified products requiring notification and non-notification — This type of submission involves product modifications that do not require EPA approval. These modifications must have no potential to cause unreasonable adverse effects to the environment. Some of these modifications can be made simply by notifying EPA (known as notification). Examples include:

  • Adding or changing alternate brand names,
  • Changing primary product name, or
  • Changing symbols and graphics (except skull and crossbones).

Other modifications may be made without notifying EPA (known as non-notification). Examples include:

  • Correcting typographical and printing errors,
  • Changing package size and net contents (with some exceptions), and
  • Changing name or address of registrant.

Label compliance and enforcement

  • There are four steps in the pesticide label review and enforcement process.
  • Imprecise or vague language can make a label misleading and unenforceable.

Label review

When conducting a label review, the Environmental Protection Agency (EPA) considers:

  • Whether a user can understand and follow the label; and
  • Whether the label is clear, accurate, and consistent with EPA policy and is enforceable by the states or EPA regions.

EPA can stamp a label as “accepted,” send the label back to the manufacturer for corrections, or begin an investigation to detect violations and/or collect evidence necessary to successfully prosecute violators.

Violation investigation

Inspectors can include representatives from state agencies, federally recognized tribes, and EPA regional offices. They may conduct inspections that are routine or “for cause,” which means they are the result of a complaint or tip. Inspectors may investigate retail establishments or pesticide dealers to see if products for sale are legal. They may also investigate use sites, such as farms, to see if misuse has occurred or if standards and labeling requirements for worker protection have been violated.

Laboratory analysis

If the investigation involves physical samples, the inspector collects those samples and submits them to a laboratory for analysis. A laboratory analyst:

  • Verifies formulation of samples.
  • May perform antimicrobial efficacy testing on samples.

Case development

To determine whether a violation has taken place, a case developer (or attorney) develops a case following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Enforcement Response Policy, as well as the administrative procedures set forth in the regulations. The case developer:

  • Reviews the inspector’s report.
  • Reviews the evidence.
  • Performs a word-for-word comparison of the accepted label and the label collected during the inspection.
  • May send an Enforcement Case Review (ECR) to the Office of Enforcement and Compliance Assurance (OECA) and Office of Pesticide Programs (OPP) to build a case. ECRs often include label interpretation questions.

If a problem is uncovered during the label review phase, a pesticide manufacturer or distributor can have a serious issue. Label problems can affect thousands of products or millions of units of one product already in the marketplace.

Language must be enforceable

Because the label is the law, imprecise or vague language can make a label misleading and unenforceable. If the label is not enforceable, then users who misuse a pesticide may not be prosecuted, and victims of a product’s misuse might not be compensated.

Pesticide imports and exports

  • Certain rules and regulations under FIFRA apply to the import and export of pesticides and pesticide devices, many of them related to registration and labeling.
  • Importers of all FIFRA-regulated pesticides and devices must comply with U.S. CBP regulations.

Certain rules and regulations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) apply to the import and export of pesticides and pesticide devices, many of them related to registration and labeling. The Environmental Protection Agency (EPA) also sets limits (known as “tolerances”) on how much pesticide residue may remain on food and feed products as well as other commodities, and these limits apply to those foods or commodities that are imported and exported.

EPA recommends that importers and exporters work with their legal counsel or enlist the aid of a pesticide regulatory consultant if they need additional assistance or clarification regarding these rules.

Importation of pesticides and related devices

  • Importers of all FIFRA-regulated pesticides and devices (including unregistered pesticides) must comply with the U.S. Customs and Border Protection (CBP) regulations set forth at 12 CFR 12.110 to 12.117.
    • Unregistered pesticides may be imported only if the import meets the conditions of one of the specific exceptions in 40 CFR 152.30.
    • Persons who are importing unregistered pesticides for the sole purpose of exporting them must comply with Pesticide Registration Notice 99-1.
  • No imported pesticide or device may be adulterated, misbranded, or otherwise violative of FIFRA.
  • All imported pesticides and devices, including unregistered pesticides, must have been produced in an EPA-registered establishment, even when the production establishment is outside the United States. The pesticide or device must also be labeled accordingly with that establishment number. The producer is responsible for submitting annual production reports to EPA.
  • Notice of Arrival of Pesticides and Devices (NOA). The CBP regulations implementing FIFRA 17(c)(1) prohibit the importation of pesticides without a completed EPA NOA. Upon entry of a shipment of pesticides or pesticide devices into the United States, and concurrent with the filing of the entry documentation, CBP must be in receipt of the information required by the EPA NOA. The EPA NOA information may be submitted on paper using EPA Form 3540-1 or electronically via any CBP-authorized electronic data interchange system. Importers and their agents are encouraged to file their EPA NOA information well in advance of their shipment’s arrival at the port of entry to allow time for EPA review, any requests for additional information, and any necessary corrections. More detailed information on the NOA filing options and procedures and tips for preventing common filing errors are available via the EPA-authored report Automated Commercial Environment (ACE) Tips and Guidelines for Filing EPA Notice of Arrival (NOA) for Pesticides and Devices, which can be found on CBP’s website.

Exportation of pesticides and related devices

  • Registered pesticides that are exported must bear labeling (or collateral labeling per 40 CFR 168.69) that is approved by EPA as part of its registration. For the requirements related specifically to the export of registered pesticides, see 40 CFR 168.69.
  • Unregistered pesticides. Pesticides intended solely for export are not required to be registered in the United States if the exporter complies with the labeling and other applicable requirements in 40 CFR 168.70 and 168.75, which in most cases will include the submission of a foreign purchaser acknowledgement statement (FPAS) to EPA. Additional information on how to file an FPAS can be found on the EPA pesticides website.
  • Pesticide devices that are exported must bear labeling (or collateral labeling per 40 CFR 168.69) compliant with 40 CFR 168.71.
  • All exporters of pesticides, devices, and active ingredients must also:
    • Keep records and permit inspections of those records in accordance with 40 CFR 169; and
    • Submit annual reports to EPA in accordance with 40 CFR 167.

Pesticide management

  • EPA requires that pesticide producers, distributors, or refillers follow the container specifications for nonrefillable and refillable containers.
  • EPA has authorized 21 states to implement their own pesticide containment regulations rather than the federal regulations.

Pesticides require special care and handling, and the Environmental Protection Agency (EPA) sets standards and requirements for pesticide containers, repackaging pesticides, and pesticide containment structures. The regulations on the management of pesticides, cited under 40 CFR 165, describes the requirements for refillable and nonrefillable containers and for properly disposing of pesticides.

In summary, EPA requires that:

  • Pesticide producers, distributors, or refillers follow the container specifications for nonrefillable and refillable containers.
  • If the company stores pesticides onsite, it must:
    • Keep pesticides in appropriate containers;
    • Provide necessary secondary containment;
    • Follow label directions;
    • Follow safety procedures; and
    • Dispose of pesticides according to federal, state, and local laws.

Pesticide containment

The pesticide container regulations establish standards for pesticide containers and repackaging as well as label instructions to ensure the safe use, reuse, disposal, and adequate cleaning of the containers. Pesticide registrants and refillers (who are often distributors or retailers) must comply with the regulations, and pesticide users must follow label instructions for cleaning and handling empty containers.

Pesticide retailers who repackage pesticides, commercial applicators, and custom blenders must comply with the pesticide containment regulations if they handle agricultural pesticides and have a stationary container or pesticide dispensing area that is covered by the regulations.

Note that EPA has authorized 21 states to implement their own pesticide containment regulations rather than the federal regulations. These states are: Colorado, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, South Dakota, Vermont, Washington, West Virginia, and Wisconsin.

Summary of pesticide container and containment structure regulations

The table below summarizes pesticide container and containment structure regulations:

CategoryWho must complyMajor requirements
Nonrefillable containers
  • Registrants
  • Department of Transportation (DOT) container design, construction, and marking standards
  • Container dispensing capability
  • Standard closures
  • Residue removal
  • Recordkeeping
Refillable containers
  • Registrants
  • Refillers (retailers, distributors)
  • DOT container design, construction, and marking standards
  • Serial number marking
  • One-way valves or tamper-evident devices
  • Stationary container requirements
Repackaging pesticide products
  • Registrants
  • Refillers (retailers, distributors)
  • DOT container design, construction, and marking standards
  • Serial number marking
  • One-way valves or tamper-evident devices
  • Stationary container requirements
Container labeling
  • Registrants
  • Pesticide users (must follow new directions)
  • Identify container as nonrefillable or refillable (all)
  • Statements to prohibit reuse and offer for recycling; batch code (all nonrefillables)
  • Cleaning instructions (some nonrefillables)
  • Cleaning instructions before final disposal (all refillables)
Containment structures
  • Ag retailers
  • Ag commercials applicators
  • Ag custom blenders
  • Secondary containment structures (dikes) around stationary tanks
  • Containment pads for pesticide dispensing areas
  • Good operating procedures
  • Monthly inspections of tanks and structures
  • Recordkeeping
  • Provisions for states with existing programs

Pesticide storage

  • Limit the amount of pesticide the company buys and stores to only what the company will use, sell, or distribute quickly.
  • Always store pesticides in their original containers with the original label attached.

For pesticides in small portable containers (such as 55-gallon drums or smaller containers), the Environmental Protection Agency (EPA) regulates pesticide storage through specific storage instructions on pesticide labels. Some states regulate the storage of pesticides in small portable containers, so be sure to check state regulations.

Storage best practices

  • Limit the amount of pesticide the company buys and stores to only what the company will use, sell, or distribute quickly.
  • When given the option, choose refillable containers and return them to the pesticide seller for refilling.
  • Read the pesticide label for specific storage and safety information.
  • Keep pesticide storage facilities away from humans and livestock and do not locate them in flood-prone areas.
  • Provide secondary containment when required.
  • Situate pesticide containers so that leaks and spills cannot reach drains, surface water, ditches, etc.
  • Secure pesticide storage areas to ensure no unauthorized entry.
  • Post storage areas with signs reading “DANGER – PESTICIDES – KEEP OUT”.
  • Do not store pesticides with incompatible pesticides or other chemicals.
  • Keep pesticides separate from food, drinking water, animal feed, seeds, etc.

Safety tips for pesticide storage areas

  • Always store pesticides in their original containers with the original label attached. However, if a pesticide container is leaking, transfer the chemical to a sturdy new container that can be sealed. Attach the original label to the new container or label the new container with specific information immediately.
  • Purchase only the quantities of pesticides required for a single season to minimize the need for off-season storage.
  • Keep the storage site neat and tidy. Pesticide handlers must be able to:
    • See pesticide labels,
    • Detect leakage or corrosion, and
    • Get to leaks or spills to clean them up.
  • Store protective equipment and clothing in a nearby location that provides immediate access but is away from pesticides and their fumes, dusts, or possible spills.
  • Provide an immediate supply of clean water and have an eyewash dispenser immediately available for emergencies. Soap and a first aid kit are also necessary.
  • Establish procedures to control, contain, and clean up spills. Familiarize everyone with the procedures.
  • Provide tools (like a shovel, broom, and dustpan) and absorbent materials (like clay, sawdust, or shredded paper) to clean up spills.
  • Mark pesticide containers with the date of purchase and rotate inventory to ensure that the oldest material is used first.
  • Keep the following:
    • An accurate, up-to-date stored pesticide inventory;
    • A file of product labels available for reference;
    • A file of safety data sheets (SDSs);
    • A building floor plan showing the exact location of pesticides; and
    • Emergency phone numbers at the storage area and in the office.
  • Maintain an inventory of all safety kits and signs.
  • Develop a fire emergency plan in consultation with the local emergency planning committee and fire, police, and sheriff’s departments. Notify the appropriate officials of the types of pesticides and quantities stored.
  • Know and follow state and local fire codes. Consult with local fire authorities regarding the best fire extinguishing agent — water, foam, dry chemical, carbon dioxide, etc.

Pesticide disposal

  • Containers that held acute hazardous wastes must be triple rinsed in order to be considered “RCRA-empty.”
  • Only certain pesticides are eligible for the universal waste program.

Pesticides are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) until they are disposed, after which they are regulated under the Resource Conservation and Recovery Act (RCRA), which ensures responsible management of hazardous waste and non-hazardous solid waste.

Many pesticides are listed or characterized as hazardous waste, or even acute hazardous waste, when disposed. If a pesticide is listed as having acute hazardous characteristics, even a small amount of pesticide waste can push a facility into the large quantity hazardous waste generator (LQG) category.

Containers that have held pesticides that are listed or characterized as a hazardous waste (either acute or nonacute) must be triple rinsed in order to be considered “RCRA-empty.” Be sure to collect any rinsate that was not used to create a spray mixture for use in application equipment and dispose of it properly in accordance with the product labeling and federal and state regulations.

However, note that in most states, pesticides can be managed as a universal waste, which streamlines the regulation of certain hazardous waste management.

Pesticides as universal waste

Only certain pesticides are eligible for the universal waste program at 40 CFR 273 or state equivalent regulation. These are:

  • Recalled pesticides that are suspended or canceled and part of a voluntary or mandatory recall under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); or
  • Unused pesticide products that are collected and managed as part of a waste pesticide collection program.

Check the state’s regulations, as some states (including California, Maine, and Washington) do not recognize pesticides as a universal waste.

Organizations that may handle pesticides under the Universal Waste Program must manage the waste in a way that prevents releases to the environment, use proper containers, adhere to all labeling requirements, and ship the pesticide(s) offsite to another universal waste generator or to a facility that is authorized to accept the pesticide within one year.

Triple rinsing

  • The procedure for rinsing containers should begin immediately after emptying the contents into the application equipment.
  • Triple and pressure rinsing pesticide containers are not viable options in certain situations.

Triple rinsing is defined by a 1974 federal regulation as the “flushing of containers three times, each time using a volume of the normal diluent equal to approximately ten percent of the container’s capacity, and adding the rinse liquid to the spray mixture.” Pesticide labels on metal, plastic, and glass containers reflect this federal definition when directing applicators to triple rinse or the equivalent.

Triple rinsing process

  1. The same personal protective equipment (PPE) worn while handling the pesticide concentrate during the mixing process should be worn while rinsing containers.
  2. The procedure for rinsing containers should begin immediately after emptying the contents into the application equipment. Allowing the residue to dry in the empty containers for even a few hours will reduce the effectiveness of the procedure. If the company can’t rinse them immediately, leave the caps on the containers until prepared to do so. This will help prevent the pesticide from drying inside the containers.
  3. Pour the pesticide into the application equipment where the spray mix is created and let the pesticide container drain for an additional 30 to 60 seconds. This step greatly enhances the ability to remove the residue during the triple rinsing process.
  4. Add clean water (or other diluent specified on the label) equal to 10 to 25 percent of the container’s volume and secure the cap.
  5. Shake or roll the container so that the interior surfaces will be rinsed.
  6. Pour the rinsate into the spray mix and allow the container to drain for an additional 30 seconds. This completes the first cycle.
  7. Repeat the procedures outlined in steps 4 to 6. This completes the second cycle.
  8. Again, repeat steps 4 to 6. If the rinsate still appears cloudy or milky, keep repeating until the water looks clear, indicating a thorough rinse. If the pesticide is an emulsifiable concentrate (EC) or a liquid flowable (LF), multiple rinses are always advisable.
  9. Render all plastic and metal containers unusable by puncturing or crushing.
  10. The final step is to dispose of the empty containers in a sanitary landfill or offer them for recycling.

Technically, if the steps above are done properly for each pesticide container, the rinsate should all be in the spray mix in the application equipment. However, if any rinsate is left over, dispose of it properly in accordance with the product labeling and federal and state laws and regulations.

When rinsing is not an option

Triple and pressure rinsing pesticide containers are not viable options in certain situations. Thorough removal of pesticide products packaged in bags and aerosol spray cans may be accomplished by taking the following steps:

Container typePesticide removal steps
Multi-layered bags
  1. Empty the contents of the bag into the tank.
  2. Shake the bag to remove as much product as possible.
  3. Cut the sides and folds to fully open the bag and add any remaining pesticide to the tank.
  4. Dispose of the cut and flattened bag in a sanitary landfill.
Aerosol spray cans
  1. Spray remaining contents on the proper site as directed by the label.
  2. Recycle or deposit the empty aerosol can in the sanitary landfill.
  • Note: Some state regulations consider the act of spraying the can to be a treatment method and/or may prohibit this. Check with the state.

Best practices

  • There are certain best practices for pesticide management such as reading and following all label instructions and never reusing pesticide containers.

Consider the following best practices:

  • Read and follow all label instructions. This includes directions for use, precautionary statements (hazards to humans, domestic animals, and endangered species), environmental hazards, rates of application, number of applications, reentry intervals, harvest restrictions, storage and disposal, and any specific warnings and/or precautions for safe handling of the pesticide.
  • Wear appropriate protective clothing and equipment when working with pesticides.
  • Rinse containers immediately after emptying because some pesticide residues will dry quickly and become difficult to remove. If the container cannot be rinsed immediately, replace the cap until it can be rinsed.
  • Never reuse pesticide containers (rinsed or unrinsed).
  • Contact the manufacturer, dealer, or business where pesticides were purchased to see if they will take back rinsed pesticide containers or unused concentrates.
  • Never allow empty pesticide containers to accumulate where unauthorized people have access to them. Such containers may be dangerous to children, pets, livestock, and wildlife, as well as adults who might convert them to other uses.
  • In the event of a pesticide spill, remove all persons from possible chemical exposure; control the spill; contain it by diking and absorbing liquid pesticides with dry material such as sawdust, kitty litter, or shredded paper; and report the spill.
  • Post medical/spill emergency telephone numbers in a prominent location.

The proper transportation and storage of pesticides and the proper rinsing and disposal of empty pesticide containers demonstrate that applicators are competent professionals who are concerned about the environment.

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