US EPA Pesticide Registration

Pesticides sold and used in the United States are strictly regulated by the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) and state regulations. The U.S. Environmental Protection Agency (EPA) is responsible for managing pesticide registration. If a pesticide product is exported to the United States and intended for use within the country, it must be registered with the US EPA  at the federal level first according to Section 136 of FIFRA, unless it is exempted. In addition, most of the States have their own specific state registration requirements, which can vary significantly in terms of data requirements, submission methods, and review periods.

Main Pesticide Regulations in the USA

• Federal Insecticide Fungicide & Rodenticide Act (FIFRA)
• Federal Food, Drug and Cosmetic Act (FFDCA)
• Food Quality Protection Act (FQPA)
• U.S. Code of Federal Regulations (CFR)
• Pesticide Registration Improvement Act (PRIA)

Who Shall Register？

Any person may apply for pesticide registrations in the USA. Foreign enterprises must designate an agent residing in the United States to act on behalf of the applicant on all registration matters.

Regulatory Authorities

• Environmental Protection Agency (EPA)
• Office of Chemical Safety and Pollution Prevention (OCSPP)
• Office of Pesticide Programs (OPP)

Pesticide Registration Types

There are three major pesticide registrations types under FIFRA:

• Conventional pesticides such as insecticides, herbicides, fungicides and rodenticides;
• Antimicrobial pesticides such as sterilants, sporicides, disinfectants, sanitizers, germicides, and products that control growth of microorganisms ;
• Biopesticides such as biochemicals, microbe-containing (microbial) pesticides and plant-incorporated protectants (PIPs).

Additionally, FIFRA also regulates pesticide devices. If an article is an instrument or contrivance that uses physical or mechanical means to trap, destroy, repel, or mitigate any plant or pest life, it is considered to be a device and subject to regulation under FIFRA. More info can be found here.

Note:

• Pesticide devices are not subject to product registrations with the US EPA. However, they must comply with regulations regarding establishment registration, reporting, recordkeeping, import and export procedures, and labeling.
•  Certain "minimum risk pesticides" pose little to no risk to human health or the environment, EPA has exempted them from federal registration. 

Registration Data Requirements

The registration data requirements vary depending on the product type (such as manufacturing-use product or end-use product), the type of registration application (identical products, similar products, new active ingredients, biopesticides), and the intended use (terrestrial/aquatic, indoor/outdoor). Typically, the registration data requirements include the following:

• Product Chemistry
• Toxicology
• Efficacy (for public health pest control products only, such as mosquito control)
• Applicator and post-application exposure
• Pesticide Spray Drift Assessment
• Environmental Fate
• Residue chemistry

The registration data can be the applicant's own new studies, or studies previously submitted to the Agency by the applicant or another person with any necessary written authorizations or offers to pay. Studies previously submitted by others over 15 years can be cited free of charge.

Pesticide Data Compensation under FIFRA

To cite another company's data, the composition and proposed uses of the “follow-on” or “me too” applicant's pesticide must be substantially similar to a previously registered product. In addition, the applicant must offer to compensate the data owner, in writing, for using the data. If the two companies are unable to reach a voluntary agreement on the amount of compensation owed either may initiate binding arbitration to resolve the dispute.

Because EPA is not involved in resolving data compensation disputes, the time required to negotiate or arbitrate a dispute will not delay the time required to obtain a me-too registration. This means that follow-on applicants typically can sell and earn profits on me-too products for several years before they actually pay any compensation.

However, if a follow-on registrant fails to comply with a data compensation agreement or an arbitration award, the data owner may petition EPA to cancel the me-too registration.

Pesticide Registration Process in USA

The picture below summarizes typical pesticide registration process in the USA.

US State Pesticide Registrations

Most of the States have their own specific state registration requirements for end-use pesticide products, which can vary significantly in terms of documentation, submission methods, review periods and fees. The state registration is usually less time-consuming and cheaper than the federal registration. Typical info required includes identification info of applicant, pesticide product labels, formula and product classification. 

Our Services

CIRS Group USA Inc can be your agent to help you navigate the complex pesticide regulatory barriers in the USA and bring your pesticide products to the US market efficiently and compliantly.  

Our services include:

• EPA Company and Establishment Registration
• Data Gap Analysis/Cost Assessment for EPA Pesticide Registration
• EPA Federal and State Pesticide Registration
• Evaluation and Negotiation of Data Compensation Fees for EPA Pesticide Registration
• EPA Registration of Pesticide Adjuvants and Disinfectants
• EPA Establishment Registration of Pesticide Devices

For more information on how we can assist with your pesticide registration needs in USA, contact us today via Email: service@cirs-group.com.