Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Guide

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) apply to pesticide products, such as insecticides, fungicides, and rodenticides, as well as pesticidal devices (e.g., ultrasonic devices).

This guide explains what you need to know about making pesticide claims, registering a pesticide product or device, and labeling your products. We also cover packaging, lab testing, and other requirements.

What is FIFRA?

According to the Environmental Protection Agency (EPA), the FIFRA sets requirements for pesticides and pesticidal devices that are distributed, sold, or used in the United States.

Pesticides and pesticidal devices must be registered by the EPA. Before you can register a product under the FIFRA, you must provide evidence that its usage does not result in:

a. Any “unreasonable risk” to human health or the environment.

b. A risk to human diets from residues of pesticide use in or on food.

The FIFRA also sets other types of requirements, which might vary according to the product. This includes the following requirements:

• Claims
• Labeling
• Packaging
• Substance restrictions

Product scope

The FIFRA regulates pesticides and pesticidal devices, two different product categories that aid in pest control.

Pesticide products

The EPA states that pesticides and pesticide products are substances meant to destroy, mitigate, prevent, or repel pests. Examples of pesticide products include:

• Insecticides
• Fungicides
• Rodenticides
• Disinfectants
• Herbicides
• Pest attractants (pest traps)
• Liquid pesticides
• Equipment sold with a pesticide-generating substance (e.g., salt)

Devices

Pesticidal devices are instruments that, while not containing substances, use physical means (e.g., electricity, or light) for pest control. Examples of such devices include:

• UV lights
• Untreated air and water filters
• Ultrasonic devices
• Replacement parts (e.g., bulbs) for pesticidal devices

Exemptions

Some pesticide products and devices are exempted from FIFRA requirements. Here are several examples of exempted products and devices listed in 40 CFR Part 152.25:

a. Treated articles or substances – Products or substances containing a pesticide to protect the product or substance (e.g., wooden products treated with insecticide to protect against insect infestation).

b. Pheromones and pheromone traps – Synthetically-produced compounds mimicking an arthropod’s pheromones that modify the arthropod’s behaviors, and pheromone-containing devices used to lure, catch, or kill specific arthropods.

c. Preservatives for biological specimens – Products used to preserve biological specimens or bodily fluids (e.g., embalming fluid).

d. Foods – Food-containing, pest-luring products.

e. Natural cedar – Cedar-containing, untreated, arthropod-repelling products

f. Minimum risk pesticides – This includes active ingredients such as citronella oil, and inert ingredients such as almond oil.

Claims

Claims made by producers for certain products (e.g., cleaning products) would affect whether the product might, or might not, be covered by the FIFRA.

Claims that the EPA considers as “Pesticidal”

Here are a few examples of claims that the EPA considers to be pesticidal, and that would result in the requirement for product registration under FIFRA:

• Removes pests by suffocating or drowning
• Cleans or removes pest habitats or breeding sites
• Sanitizes, disinfects, or sterilizes

Claims that the EPA does not consider as “Pesticidal”

The EPA does not consider types of claims such as the following to be pesticidal:

• Cleans or removes stains
• Cleans a site
• Cleans, reduces or removes sludge

Claims that the EPA may or may not consider as “Pesticidal”

The EPA may consider products claiming pesticidal properties based on context and use, potentially subjecting them to the FIFRA requirements if claims indicate pest-mitigation properties.

For instance, sometimes websites or catalogs may list cleaning products and pesticides next to each other. This listing, then, would suggest that the cleaning products have pesticidal properties.

Conversely, websites or catalogs could list their products in different sections to avoid suggesting that cleaning products have pest-deterrent properties.

Registration requirements

The EPA requires applicants to register their pesticide products and devices under FIFRA for sale in the US and adhere to the registration procedure detailed in the Pesticide Registration Manual, which can be browsed here.

Applicants may also refer to 40 CFR Part 152.50 for details on what to include in their registration application, and to 40 CFR Part 152.30 for products exempted from registration.

Products subject to registration under FIFRA

According to the EPA, a product is subject to registration under FIFRA if it is meant to mitigate pests, contain pest-prevention substances, or if it sold with a pesticide-generating substance. Here, we list a few examples of products subject to registration:

• Insecticide
• Disinfectants
• Pest attractants

Exemptions

Examples of products exempted from FIFRA registration include those that are:

a. Transferred between registered establishments operated by the same, or different, producers.

b. Distributed or sold under an “experimental-use” permit or an emergency exemption.

c. Transferred exclusively for export or disposal purposes.

d. Existing stocks of a formerly-registered product.

Note that pesticides exempted from registration may still be subject to other FIFRA requirements.

Registration procedure

40 CFR Part 152.42 states that those who wish to register a new pesticide product, or apply for amendment of their product registration, must apply for registration to the EPA. The application must contain the following information:

1. The applicant’s identity – Name, correspondence address, authorized agent (if applicable), and company number (if assigned by the EPA).

2. Application summary – A list of data, a brief description of studies carried out, and a statement declaring the pesticide’s fitness for public release after registration per 40 CFR Part 152.119.

3. Product identity – The product’s name, trade name, and EPA Registration Number (if currently registered).

4. Draft labeling – Five legible copies of draft labeling (e.g., mockup or typescript), and any proposed changes to the labeling for applications for amended registrations.

5. Registration data – FIFRA compliance materials, data specified in 40 CFR Parts 158 or 161, and factual information regarding unreasonable negative health or environmental effects

6. Certification regarding child-resistant packaging – Applicants must submit information certifying the product’s distribution or sale exclusively in child-resistant packaging, per 40 CFR Part 157.

7. Request for classification – Applicants requesting a classification that differs from that established by the EPA in 40 CFR Part 152.164 must submit a request for that classification, as well as supporting information.

8. Statement concerning tolerances – Applicants must submit a statement specifying the authorization, or exemption from the requirement, of chemical residue tolerances.

9. Fees – Applicants must identify the appropriate fee category in FIFRA’s sec. 33 schedule, and submit the fee for that category per the EPA’s latest notice.

Registrants must send their applications, and correspondence regarding registration, to the Office of Pesticide Programs’ Document Processing Desk at the relevant address specified in 40 CFR Part 150.17.

Labeling requirements

The FIFRA requires producers to label their pesticide products and devices. They must ensure that they provide the proper label content, and securely attach it to the product or container.

Producers must also refrain from providing false and misleading statements and must provide precautionary statements and instructions.

Labeling content

Producers must ensure that the contents of the label contain the following, per 40 CFR Part 156.10:

• The product’s name, brand, or trademark
• The registrant’s, or producer’s, name and address
• The net contents (weight or measure) of the pesticide product or device
• The product’s, or device’s, registration number
• The producing establishment’s registration number
• A statement declaring the ingredients in percentages
• Hazard and precautionary statements
• Directions for use
• Statement of use classifications

Labeling placement

The pesticide product’s or device’s immediate container must carry a securely attached label.

The label is expected to remain affixed to the immediate container during the product’s use. If the readability of the label on the immediate container is hindered, then the label must be securely attached to the immediate container’s wrapper or outside package.

Tank cars and other bulk containers

The shipping papers must carry a copy of the accepted label and be left with the recipient of the tank cars or bulk containers at the time of delivery.

When pesticide products are stored in mobile or stationary bulk containers, a copy of the labeling, including relevant usage directions, must be securely attached to the container next to the discharge control valve.

False or misleading statements

Pesticide products or devices subject to the FIFRA are deemed to be misbranded if the labeling provides false or misleading claims. Examples of such false and misleading statements include, but are not limited to:

a. Those that imply its recommendation by any Federal Government agencies.

b. True statements worded to provide false or misleading impressions to users.

c. Safety claims (e.g., “Nonpoisonous” or “harmless”).

d. Comparative safety statements (e.g., “Pollution approved” or, “Contains all natural ingredients”).

Precautionary statements

According to Subparts D and E of 40 CFR Part 156, precautionary statements are meant to direct or inform users to take action to avoid human (and, if applicable, domestic animals) and environmental hazards or mitigate their effects.

There are different toxicity categories, which generally require different precautionary statements.

Note that products are categorized based on their capacity to hurt or irritate the user, where category I is considered the most toxic.

Human (and if applicable, pet) hazard precautionary statements (systemic effects)

Here, we list some examples of precautionary statements warning concerning the systemic effects of pesticides:

a. Toxicity category I – “Fatal (poisonous) if swallowed [inhaled or absorbed through skin]. Do not breathe vapor [dust or spray mist]. Do not get in eyes, on skin, or on clothing.”

b. Toxicity category II – “May be fatal if swallowed, [inhaled or absorbed through the skin]. Do not breathe vapors [dust or spray mist]. Do not get in eyes, on skin, or on clothing.”

c. Toxicity category III – “Harmful if swallowed [inhaled or absorbed through the skin]. Avoid breathing vapors [dust or spray mist]. Avoid contact with skin [eyes or clothing].”

Human (and if applicable, pet) hazard precautionary statements (irritation effects)

Here are examples of precautionary statements warning concerning the irritation effects of pesticides:

a. Toxicity category I – “Corrosive, causes eye and skin damage [or skin irritation]. Do not get in eyes on skin, or on clothing. Wear goggles or face shield and rubber gloves when handling. Harmful or fatal if swallowed.”

b. Toxicity category II – “Causes eye [and skin] irritation. Do not get in eyes, on skin, or on clothing. Harmful if swallowed.”

c. Toxicity category III – “Avoid contact with skin, eyes or clothing.”

Human (and if applicable, pet) hazard precautionary statements (sensitizers)

Additionally, if the pesticidal product is a sensitizer, which is not classified under any category, its precautionary statement should read as follows:

“Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.”

Physical or chemical hazards precautionary statements

40 CFR Part 156 also contains precautionary statements concerning specific physical or chemical hazards.

Here is an example:

“Extremely flammable. Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 130 °F may cause bursting.”

Environmental hazard precautionary statements

The EPA may require precautionary statements for the existence of environmental hazards to non-target organisms.

For example, labels on products meant for outdoor use other than aquatic applications must bear the following precautionary statements:

“Keep out of lakes, ponds or streams. Do not contaminate water by cleaning of equipment or disposal of wastes.”

First aid statements

First aid statements might also be required. The following heading should be used:

“First Aid” or “Statement of Practical Treatment.”

Signal words

Besides precautionary statements, signal words are also necessary. Signal words are different according to the Toxicity category:

a. Toxicity category I: “DANGER”

b. Toxicity category II: “WARNING”

c. Toxicity category III: “CAUTION”

d. Toxicity category IV: No signal word is required, but “CAUTION” might be used.

Note that products of toxicity category IV for which no signal word is used should include the following warning:

“Keep Out of Reach of Children.”

Instructions

40 CFR Part 156 lists different types of instructions. We list some examples below.

Residue removal instructions for nonrefillable containers

40 CFR 156.146(b)-(d) provides instructions for triple rinse, pressure rinse, and non-water diluents. These instructions must be preceded by one of the following statements:

a. “Clean container promptly after emptying.”

b. “Triple rinse or pressure rinse container (or equivalent) promptly after emptying.”

c. “Triple rinse container (or equivalent) promptly after emptying.”

Residue removal instructions for refillable containers

40 CFR 156.156(b) requires the provision of instructions for residue removal before container disposal. These instructions must be preceded by one of the following statements:

a. “Cleaning the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”

b. “Pressure rinsing the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”

Packaging requirements

Subpart B of 40 CFR Part 157 covers child-resistant packaging requirements for pesticides and devices covered by the FIFRA.

Child-resistant packaging

This part defines child-resistant packaging as packaging designed and manufactured to considerably hamper the ability of children aged under 5 years to open, but that is not difficult for normal adult use.

Products that need child-resistant packaging are listed in 40 CFR Part 157.22, according to toxicity and usage criteria.

Exemptions

Per 40 CFR Part 157.24, the EPA generally exempts from child-resistant packaging requirements pesticide products that are either classified for restricted use or packaged in large sizes.

Products classified for restricted use

The EPA does not require the distribution or sale of products in child-resistant packaging if those products are regulated for use by, or under observation of, an authorized applicator.

Notwithstanding this exemption, however, it may require restricted-use products to have child-resistant packaging if it can reduce the product’s risk of serious injury or illness.

Products packaged in large sizes

Products packaged in the following sizes do not require child-resistant packaging:

a. 50 pounds or greater – if the product is solid, regardless of pesticide type.

b. 7.5 gallons or greater by volume – if the product is liquid and meant for use in swimming pools.

c. 5 gallons or greater by volume – if the product is liquid and meant for other pesticide use.

d. 2 pounds or greater by weight – if the product is packaged as an aerosol, regardless of pesticide type.

Standards

The EPA provides three types of standards to which registrants must ensure their product’s child-resistant packaging meet:

• Effectiveness standard
• Compatibility standard
• Durability standard

Child-resistant packaging might require testing using the protocol specified in 16 CFR Part 1700.20 to meet the effectiveness specifications in 16 CFR Part 1700.15(b). Both of these parts are under the Poison Prevention Packaging Act (PPPA).

Certification

Per 40 CFR Part 157.34, registrants of pesticide products requiring child-resistant packaging must submit to the EPA a certification that the package meets the standards listed previously.

Contents of certification

The EPA mandates that registrants ensure the certification contains the following information:

a. The product’s name and EPA registration number.

b. The registrant’s name and address.

c. The date.

d. The certifying company official’s name, title, and signature.

e. A certifying statement declaring that the product’s packaging meets 40 CFR 157.32’s standards.

Certification requirements

Subpart B of 40 CFR Part 171 establishes certification requirements for applicators of “restricted use pesticides”. Such restricted-use pesticides include, but are not limited to, those used for:

• Agricultural (crop or livestock) pest control
• Ornamental and turf pest control
• Aquatic pest control
• Industrial, institutional, and structural pest control
• Regulatory pest control
• Sodium cyanide predator control
• Soil fumigation
• Aerial pest control

The EPA requires commercial, private, and certified applicators to adhere to different standards for certification. Here are examples of three requirements about their respective applicators:

a. Commercial applicators – Must pass a written examination that determines the competency in their usage and handling of restricted-use pesticides.

b. Private applicators – Must be certified by relevant certifying authority as having competency in the usage of restricted-use pesticides.

c. Certified applicators – Certified commercial and private applicators must be recertified within five years by a certifying authority to maintain their continued competency.

Worker protection standards

Manufacturing facilities that handle pesticides must establish protocols for handling exposure-related situations and employ working practices that aim to minimize or eliminate pesticide exposure.

As the FIFRA bans registration of unreasonably harmful pesticides, the EPA uses restrictions and label requirements for specific pesticides, as well as Worker Protection Standards (40 CFR Part 170) to protect agricultural workers. The standards, which address lowering the risk of disease or harm brought on by occupational pesticide exposures, establish the following:

• Ventilation criteria
• Entry restrictions
• Personal protective equipment guidelines
• Information display requirements

Substance restrictions

Subpart C of 40 CFR Part 180 contains a list of specific tolerances for residues of pesticide chemicals on different food products.

Here we provide some examples:

• Captan (fungicide) < 20 ppm for blueberries
• Diuron (herbicide) < 0.05 ppm for grape
• Imidacloprid (insecticide) < 0.05 ppm for fish
• Malathion (insecticide) < 8.0 ppm for green onions
• Ziram (fungicide) < 0.10 ppm for hazelnut

Lab testing

The EPA might require producers to have their formulas for pesticide products and devices under the FIFRA lab tested to determine:

• The risks and benefits of pesticide products
• How safe pesticide chemical residues are, under FFDCA sec. 408

Additionally, testing according to the PPPA requirements might be required for child-resistant packages.

Test guidelines

The EPA’s test guidelines, which cover pesticides and toxic substances, specify their recommended methods. Producers may use those methods to submit data to the EPA to support:

a. Registration of pesticides under FIFRA.

b. Setting of tolerances, or exemptions for such, for pesticide residues under FFDCA sec. 408.

Good laboratory practice

40 CFR Part 160 provides good laboratory practices for performing studies meant to support research applications or marketing permits for EPA-regulated pesticide products.

This part is meant to help labs ensure the integrity and quality of their submitted data.

Testing companies

Here are a few companies that offer testing against the FIFRA requirements:

• Eurofins
• SGS
• Pacific BioLabs
• OMIC USA Inc
• North Coast Laboratories Ltd.