With the development of the North American epidemic and the increasing demand for sterilization, disinfection, insect repellent, and mosquito-killing electrical products and equipment in the post-epidemic era, more and more disinfection and antibacterial appliances, air sterilization equipment, and non-insect and mosquito-repellent Large quantities of electrical products or equipment for medical purposes are exported to the United States. In accordance with the requirements of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA: Federal Insecticide, Fungicide and Rodenticide Act), electrical products such as sterilization, disinfection, insect repellent, and mosquito control are all within the scope of EPA control. Therefore, the majority of manufacturers and sellers need to pay special attention to the specific control requirements of EPA to avoid being denied entry when the goods enter the US customs.
The electrical products and equipment regulated by EPA are as follows:
Ozone disinfector, ultraviolet disinfection, UV water filter, UV air filter, UV mosquito lamp, ultrasonic insect repellent equipment, UV sterilizer, high frequency bird repellent, electronic mouse repellent, air sterilization and purification equipment, and insect-killing appliances Equipment that uses physical functions to realize disinfection and insecticide. Manufacturers of the above categories of products need to apply to EPA and complete the company registration, obtain the EPA establishment number (Establishment Number), and provide the first export report and subsequent annual reports.
Specific control requirements:
The Federal Pesticide, Fungicide, and Rodenticide Act of the United States FIFRA was enacted in 1947 and is included in the U.S.C. Chapter 7, Section 136. It stipulates that all the above-mentioned product categories sold in the United States or exported to the United States belong to the United States Environmental Protection Agency•EPA controlled products, and are controlled in the following two ways:
• For insecticidal sterilization products (chemical substances will be used), such as pesticides, herbicides, antibacterial agents, etc., these products need to be registered in accordance with FIFRA directives and product registration (please contact us for such products Further consultation).
• For disinfection, sterilization, insect repellent, and mosquito killing devices (Pesticide Device) that use physical methods to achieve established functions (such as UV or ozone), only company registration is required.
Manufacturer establishment number application
1. According to the requirements of the FIFRA Act, the manufacturers of these controlled devices must first obtain a company number (Company Number, usually composed of 5 digits XXXXX) through EPA;
2. After obtaining the establishment number issued by the EPA (Establishment Number, which consists of the company number plus the country and factory identification suffix, for example, XXXXX-CHN-01), the first export report must be completed within 30 days (Initial Report);
3. Every subsequent year, the EPA production report must be submitted before March 1.
In addition, in accordance with the FIFRA Act and the Federal Regulations 40 CFR Part 156, the labels and product information of these controlled devices must also meet the following requirements:
• The manual must make a rigorous and correct statement on the performance of the product, and cannot use any statements that may be misleading or deceptive;
• The label must be printed with the EPA establishment number (Establishment Number);
• Product packaging needs to meet the requirements of FIFRA section 25(c)(3);
• The product must have related warnings, etc.
State Registration requirements
Since the United States is a federal country, there will be some differences between State Law and Federal Regulation/Art. That is, products that meet the requirements of Federal Regulations may not necessarily meet the requirements of state laws. Therefore, for EPA-controlled Pesticide Devices (Pesticide Devices), in addition to meeting the requirements of FIFRA, if the products will be sold in the following 8 states, they also need to meet the special requirements of these states. The governments of these states require State Registration for these products, including submission and review of efficacy data and labels, before they can be sold or distributed in the state. Among them, Hawaii and Indiana also need to provide relevant sterilization efficacy reports. See the table below for specific requirements:
State registration content | State government registration time (natural days) | State registration validity period (years) | |
Colorado | Factory information and product information | 21 | 1 |
Hawaii | Factory information, product information, and sterilization efficiency report | 44 | 3 |
Indiana | Factory information, product information, and sterilization efficiency report | 21 | 1 |
New Mexico | Factory information and product information | 24 | 1 |
Oklahoma | Factory information and product information | 11 | 1 |
Wyoming | Factory information and product information | 15 | 1 |
District of Columbia | Factory information and product information | 7 | 1 |
Puerto Rico | Factory information and product information | 135 | 2 |
In order for your company's products to enter the American market smoothly, you can contact the ZRLK testing agency for help and advice on meeting these new market requirements. ZRLK has focused on testing and certification of batteries and peripheral consumer products for 15 years, always paying attention to changes in national regulations, and providing customers with one-stop certification services in multiple countries and regions to ensure that your products quickly enter the target market. Companies can call to consult related businesses.
