The US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is a combination of scientific, legal, and administrative procedures through which the EPA examines the ingredients of the pesticide the site or crop where it is to be used the amount, frequency, and timing of its use and storage and disposal practices.
Pesticides products in the US can be categorized into 3 groups – conventional pesticides, antimicrobial pesticides, and biopesticides. The EPA’s conventional pesticides group includes all ingredients other than biological pesticides and antimicrobial pesticides. As for antimicrobial pesticides, they are substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms whether bacteria, viruses, or fungi on inanimate objects and surfaces. The antimicrobial category is also known as a “disinfectant” in other countries. Meanwhile, biopesticides are pesticides derived from certain natural materials. Irrespective of the type of pesticides, and/or whether they are produced locally or by foreign manufacturers and imported for sale or distribution in the United States, they are required to be registered with EPA for sale in the United States.
Registration for a Pesticide Product
If you would like to obtain a registration for a pesticide (or disinfectant) product, you are required to submit complete information and data to support the registration. The information required includes but is not limited to the following:
- Company number – a number assigned by EPA to your company
- Establishment number (if applicable) – a unique number assigned to each production facility
- Identity of the product – the unique brand name of the product
- Draft label – critical information about how to handle and safely use the pesticide product and avoid harm to human health and the environment
- Applicable scientific data on product chemistry, residue chemistry, environmental fate, toxicology, wildlife, and aquatic organism among others
- Efficacy (Product Performance) data – applicable to control pests of public health importance such as roaches, viruses, pathogenic bacteria, ticks, rats among others
- Child-resistant packaging certification
- Confidential Statement of Formula
- US Agent (only for applicants not residing in the US)
Obtaining a Supplemental Registration to Distribute a Product Registered by Someone Else
An applicant who does not wish to register and produce its unique product (but would rather market a product that is currently registered to another company) may become a supplemental registrant for the company that has already registered the product. This supplemental registration allows the new registrant to market the product under its own company and brand name. To use the supplemental registration process, both parties (the original registrant and the supplemental distributor) must submit a complete application detailing the:
- address of the registrant of the basic registered product
- basic registered product and the registration number of the federally registered product
- name and address of the distributor, the distributor’s company number, and the name of the distributor product
It is instructive to note that supplemental registration is an extension of the basic registration and if the basic registered product is canceled, the supplemental registration is automatically canceled effective on the same date as the basic registered product, and existing stocks must be sold in the same time period.
Screening and Review Timelines
As soon as the application for pesticide/disinfectant registration is submitted to EPA, the Agency will screen the application within 21 days to determine if it contains all required forms, labeling, data format, and documentation of fee payment. Any deficiencies identified during the 21-day Content Screen and uncorrected by the applicant may lead to the Agency’s rejection of the application and retention of 25% of the fee.
Following the 21-day Content Screen, EPA will conduct a Preliminary Technical Screen within 45 days after the start date for pesticide/disinfectant submissions with decision review timeframes ≤6 months, and, within 90 days for pesticides/disinfectant submissions with decision review timeframes > 6 months.
If the application fails the technical screen, and the deficiencies cannot be corrected by the applicant within 10 business days after receipt of EPA’s notification of deficiencies, such application will be rejected and a maximum of 75% fee refund may be provided, if appropriate.
