1. Regulatory Consultation & Planning: Analyze product compliance and develop registration strategy.

2. Application Agency Services: Assist in appointing US Agent and complete company/facility registration.

3. Data Support:

·Toxicological and environmental impact data assessment for chemical products

·Negotiation of data compensation fees for existing studies

4. Documentation & Submission: Compile test reports/technical dossiers and monitor EPA review process.

5. Annual Maintenance: Submit required annual reports to maintain active registration.

6. Label Compliance Review: Ensure product labels meet FIFRA and 40 CFR requirements.

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1. Definition and Background

The U.S. Environmental Protection Agency (EPA), established in 1970, regulates pesticides, antimicrobial devices, engine emissions, and related products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA registration evaluates environmental and health impacts to ensure product safety and ecological sustainability.

2. Applicable Scope

·Pesticides/Chemicals: Insecticides, fungicides, herbicides, disinfectants, antimicrobials.

·Physical Devices: UV sterilizers, ozone generators, ultrasonic pest repellers.

·Engines/Power Equipment: Gasoline/diesel engines, agricultural machinery (subject to EPA emission standards).

·Other Regulated Products: Water/air treatment systems, waste recycling equipment.

3. Basic Requirements

·U.S. Agent Requirement: Non-U.S. companies must appoint an in-country agent (individual or company) to file applications.

·Facility Registration: Obtain EPA-issued "Company Number" and "Establishment Number."

·Labeling & Reporting:

Product labels must include EPA Establishment Number and shall not contain misleading claims. Initial production report must be submitted within 30 days post-registration; annual reports due by March 1 thereafter.

·Testing Requirements:

Chemical products: Must submit toxicological and environmental impact data.

Engine products: Required to pass EPA-approved emissions testing.

Data compensation fees mandatory when referencing protected studies (within 15-year exclusivity period).

4. Registration Process

1）Preparation: Categorize product, appoint agent, compile documentation.

2）Submission:

·Online registration for Company/Establishment Numbers.

·Submit test reports (chemicals/engines).

3）Review: EPA processing takes 30 days–9 months; approval grants compliance certificate.

4）Maintenance: Submit annual reports; maintain active agent status.

5. Regulatory Basis

·Primary Laws:

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA): Regulates the production, distribution and use of pesticides and antimicrobial devices.

Clean Air Act (CAA): Establishes emission standards for engines and power equipment.

·Supporting Regulations:

Federal Food, Drug, and Cosmetic Act (FFDCA), Pesticide Registration Improvement Act (PRIA), etc.

40 CFR Part 156 (Labeling Requirements), 40 CFR Part 158 (Data Submission Requirements), etc.