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 ingredientâ€� 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 means the ingredient that prevents, destroys, repels, or mitigates a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer.

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

Appurtenance means 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 means 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 means 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 means 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 means 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 means ingredients in a pesticide that do not act as active ingredients.

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

Labeling means 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 means 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 means the time after the end of a pesticide application during which entry into the treated area is restricted.

Restricted use pesticide means a pesticide that is classified for restricted use under the provisions of FIFRA 3(d) and 40 CFR 152, subpart I.

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

Rodenticide means 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 means surface water leaving the target site.

Secondary containment unit means 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 means 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 means 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,â€� which is defined as “reasonable certainty that no harm will result from aggregate exposure to the pesticide residue.â€� 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.

Company and establishment numbers

• A “company numberâ€� 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�.

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.â€�
• “The labeling must be in possession of the user at the time of application.â€�
• “Read the label affixed to the container for [product name] before applying.â€�
• “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].â€�

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.