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EPA is the abbreviation of U.S. Environmental Protection Agency (U.S. Environmental Protection Agency). According to the U.S. Federal Pesticide, Fungicide and Rodenticide Act (FIFRA: Federal Insecticide, Fungicide and Rodenticide Act) requirements, sterilization, disinfection, insect repellent, mosquito control class of electrical equipment belongs to the scope of EPA control.


The U.S. FIFRA Federal Insecticide, Fungicide and Rodenticide Act was enacted in 1947 and is included in the U.S. Code U.S.C. Chapter 7, Section 136. Its provisions of all sales in the United States or exported to the United States of insecticides and sterilants, disinfection and sterilization equipment, insect and bird repellent equipment and air sterilization and purification equipment, all belong to the U.S. Environmental Protection Agency EPA control products, and through the following two ways to control:


1, for sterilization products (will use chemical substances) such as pesticides, insecticides, herbicides, antimicrobial agents, etc., these products need to be in accordance with the FIFRA directive for business registration and product registration.


2, for the use of physical means to achieve the established function (such as UV or ozone) of disinfection, sterilization, insect repellent, mosquito control device (Pesticide Device), only need to register the enterprise.


I. EPA-regulated electrical products and equipment (Regulated Devices) include:


Ozone Sterilizers, Ultraviolet Sterilizer Lamps, UV Water Filters, UV Air Filters, UV Mosquito Lamps, Ultrasonic Insect Repellents, UV Disinfectors, High Frequency Bird Repellents, Electronic Rodent Repellents, Air Sanitizing and Purifying Equipment, and Insecticidal Electrical Appliances, etc., which are physically designed to sanitize and disinfect, and the manufacturers of these products are required to apply to the EPA for and complete business registration to obtain the EPA Manufacturer Establishment Number, and provide the initial export report and subsequent annual reports. Manufacturers of these products are also required to apply for and complete business registration with the EPA, obtain an EPA Establishment Number, and provide an initial export report as well as subsequent annual reports.

 

(ii) Establishment No. Application:


Under the requirements of FIFRA, manufacturers of these regulated devices must first obtain a company number (usually a 5-digit XXXXXX) through the EPA;


After obtaining an EPA-issued Manufacturer's Establishment Number (MEN), which consists of the company number plus a country and plant identification suffix, e.g., XXXXX-CHN-01, an Initial Report must be completed within 30 days;


Subsequent annual EPA production reports must be submitted by March 1st of each year.


In addition, the labeling and product information for these regulated devices must meet the following requirements in accordance with FIFRA and federal regulations at 40 CFR Part 156:


The instructions must make rigorous and correct claims about the performance of the product and not use any statements that could be misleading or deceptive in nature;


Labels must bear the EPA Establishment Number;


Product packaging must meet the requirements of FIFRA section 25(c)(3);


The product must have relevant warnings, etc.

 

Basic Process:


1: Apply for obtaining EPA company number;

2: Apply for an Establishment Number;

3: After successful registration - submit the last annual report within one month;

4: Export clearance requires submission of EPA Form 3540-1 application form;

5: Submit the last annual report before March 1 of the following year.