Carroll-Loye

Generally any substance or mixture of substances claiming to prevent, destroy, repel, or mitigate a pest. Legal sales of pesticides can only be made following proper registration.

Federal: The U.S. Environmental Protection Agency (EPA) oversees all pesticide registrations. Synthetic pesticides are managed by the Registration Division, while biopesticides fall under the Biopesticide and Pollution Prevention Division. State: Individual state regulatory agencies, such as the Department of Pesticide Regulation in California or the State Chemist in Indiana, enforce local pesticide regulations.

EPA-Registered: These pesticides are reviewed and approved by the U.S. EPA to ensure they meet federal safety and efficacy standards. The registration process, regulated under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), requires manufacturers to submit scientific data on toxicity and environmental impact. FIFRA-Exempt: Some pesticides are exempt from EPA registration under FIFRA Section 25(b) if they contain active and inert ingredients considered safe. These "minimum risk pesticides" do not require extensive testing but must comply with state regulations. They are typically made from natural or low-risk substances, such as essential oils, and do not carry an EPA registration number.

Active ingredient list is found here: View list Inert ingredient list is found here: View list

All insect repellents are considered pesticides by the EPA.

Determine Eligibility: Ensure the product meets EPA registration requirements and is not exempt under FIFRA 25(b). Presubmission Meeting: Meet with EPA to determine submission requirements Generate Data: Submit scientific data on toxicity, efficacy when required, environmental impact, and product chemistry. Submit an Application: Apply through the EPA’s Pesticide Submission Portal (PSP), including a draft product label and supporting documents. The registration package will require dozens of documents reporting the outcomes of supporting studies. EPA Review: The EPA evaluates the application for safety, effectiveness, and compliance with federal regulations. Approval & Registration Number: If approved, the product receives an EPA registration number, which must appear on the label before sale. Carroll-Loye Biological Research provides consulting for all of these steps. Contact us today

Physical Chemistry Data (e.g., pH, viscosity, density, stability) Toxicological Data (e.g., acute toxicity, skin and eye irritation, dermal sensitization) Efficacy Data (e.g., mosquito or tick repellency duration, effectiveness against target pests)

The registration timeline can vary significantly depending on the product type, formulation complexity, and specific EPA data requirements. We can provide a more accurate estimate following a consultation. Careful preparation and planning is important for your project to be successful.

PRIA (EPA) Fee: The Pesticide Registration Improvement Act (PRIA) fee is required for EPA registration applications. The fee varies depending on the type of product and its intended use. Follow this link to view current fees. Individual State Registration Fee: In addition to the federal fee, individual states may charge their own registration fees for products sold within their jurisdiction. These fees vary by state.

Active ingredients and end products require independent registration submissions. All active ingredients used within end products need to come from EPA registered sources. All non-active ingredients must be present on EPA’s list of approved inert ingredients.

Some essential oil based repellents are exempt from Federal EPA registration as long as all ingredients are present on the EPA’s allowed minimum risk 25(b) ingredient lists. Note that all insect repellents require State registration prior to sales within each State. Note that EPA does not allow the use of the term “natural” on any pesticide product labeling. EPA does provide special consideration to naturally occurring compounds as active ingredients in federally registered products. Reduced data sets are allowed for such biopesticidal active ingredient registration packages. Organic designations for specific chemical ingredients fall outside of EPA’s jurisdiction.

EPA registered ingredients are DEET (N,N-diethyl-m-toluamide), Picaridin, IR3535, Oil of lemon eucalyptus (OLE) and para-menthane-3,8-diol (PMD), Catmint (Nepetalactone). Carroll-Loye Biological Research generated the original efficacy data for all repellent chemistries that followed DEET 25(b) FIFRA exempt repellent actives include Geraniol, Thyme oil, Citronella oil, Peppermint oil, Eucalyptus oil, Lemongrass oil, Rosemary oil, Clove oil, Cinnamon oil, Lavender oil, Lemongrass extract, Soybean oil, Garlic oil, Cedarwood oil.

Yes. EPA requires all new repellent formulations to have data showing reasonable safety levels for acute dermal, oral, and ocular toxicity and dermal sensitization, while spray products must also have data on inhalation toxicity. Registrations of new active ingredients require much more comprehensive toxicological characterization, including tests for chronic exposures, and tests for mutagenicity and teratogenicity (birth defects). Small revisions to existing registered repellent products (e.g., minor cosmetic tweak or substitutions of like inserts) may be exempted from further tox screening at EPA’s discretion. If you would like, Carroll-Loye can identify your toxicology requirements, negotiate your data needs with EPA, and manage the acquisition of the data.

EPA-registered insect repellents must meet strict labeling requirements to ensure safety, efficacy, and compliance with federal regulations. Here are the key requirements: 1. Required Statements on the Label Product Name: Must not be misleading and should include the word "repellent." Active Ingredients Statement: List all active ingredients and their percentages. EPA Registration Number: Must be clearly displayed. EPA Establishment Number: Identifies where the product was produced. Directions for Use: Includes specific application instructions, frequency, and any age restrictions. Precautionary Statements: Covers hazards to humans and pets, first aid instructions, and any safety warnings. Storage and Disposal Instructions: Provides guidance on proper storage and disposal to prevent environmental contamination. 2. Effectiveness Claims and Limitations Label claims must be scientifically supported and approved by the EPA. The label cannot claim the product to be "safe," "non-toxic," or make unproven efficacy statements. If the product repels specific insects, this must be backed by EPA compliant testing for health related pests. 3. Child Safety Requirements Must indicate if the product is not recommended for use on children under a certain age. Child-resistant packaging may be required based on toxicity. 4. Environmental and Health Warnings Any potential environmental hazards must be clearly stated, including risks to water sources or pollinators. Labels may require "Keep out of reach of children" or "Caution," "Warning," or "Danger" depending on toxicity level. 5. Net Contents & Manufacturer Information The net weight or volume must be displayed. Manufacturer or distributor contact information must be included for consumer inquiries.

The label cannot make claims that the product is "safe," "non-toxic," or make unproven efficacy statements.

Allowed label claims: Claims regarding Effectiveness Against Specific Pests Labels can state that the product repels specific insects (e.g., mosquitoes, ticks, fleas) if supported by efficacy data submitted to the EPA. Example: "Repels mosquitoes that may carry Zika virus." Claims for Duration of Protection The label may specify how long the product repels insects if the claim is backed by EPA-reviewed test data. Example: "Provides up to 8 hours of protection against mosquitoes." Claims of Repelled Pest Disease Association (with Conditions) The label can mention that the product repels insects that may carry diseases, but it cannot claim to prevent disease transmission. Example: "Repels ticks that may carry Lyme disease." Not allowed: "Prevents Lyme disease."