Overview

Pesticide regulation in the United States is regulated by the United States Environmental Protection Agency (U.S. EPA), and therefore, US pesticide regulations are often referred to as US EPA regulations.

One of the most important regulations is FIFRA, or the Federal Insecticide, Fungicide, and Rodenticide Act. This regulation is the legal basis for the regulation of pesticides in the United States. FIFRA is the Federal statute that governs the registration, distribution, sale, and use of pesticides in the United States. Generally, before a pesticide may be sold or distributed in the United States, it must be registered (licensed) with EPA.

In addition to FIFRA, there are two other supporting laws:

• Pesticide Registration Improvement Act, or PRIA. There are more than 200 pesticide registration action codes in the United States. As a supplement to FIFRA, PRIA gives detailed clarification for different registration action codes, their applicable scope, review decision time, and EPA administration fee.
• Code of Federal Regulations (or CFR). There are 50 Titles in total, covering all federal regulations. The contents related to pesticide registrations are in Title 40. It covers the relevant registration procedures, data requirements, data protection, etc., serving as the implementation regulation to FIFRA.

Corporate Obligations and Coping Strategies

Registration Scope

FIFRA’s regulatory scope includes conventional pesticides, biopesticides and Antimicrobial pesticides (i.e. disinfectants), including active ingredients, formulations and corresponding pesticide inert ingredients (solvents, stabilizers, safety agents, etc.).

Exemptions Situation

• Treated articles
• Pheromones and pheromone traps
• Preservatives for biological specimens
• Foods
• Natural cedar
• Minimum risk pesticides

Who Should Register?

Pesticide registration is not only an obligation of pesticide manufacturers, traders, distributors, and pesticide users can also apply for EPA pesticide registration if necessary.

Besides, foreign companies must designate a U.S. agent to receive correspondence and represent them in matters concerning their application.

Compliance Obligations

• Obtain a company and establishment number
• Submit an initial report and annual report for pesticide-producing establishment
• Federal product registration
• State product registration
• Annual maintenance fee of registration certificate

Pesticide Registration Process

Registration Process

US EPA pesticide registration process

Registration Type

US EPA pesticide registration type decision

For US EPA pesticide registration, the simplest type of registration is me-too Product registration, which is determined on the following basis:

The identical/similar product registration is a short and cost-effective type of registration compared to other registration types, which can cost hundreds of thousands of dollars and take up to two years to review. In addition, new product registration, other than new use, or new active ingredient, is also a cost-effective type of registration.

Review Procedures

Fee Waivers

An applicant that qualifies as a small business is eligible for a partial waiver of 50% or, in some cases, 75% of the registration service fee. The fee waivers apply to both domestic and foreign registrants. A small business means a corporation, partnership, or unincorporated business that fulfill the requirements below:

Pesticide Reevaluation

EPA reviews each registered pesticide at least every 15 years to ensure that each pesticide can carry out its intended function(s) without creating unreasonable adverse effects to human health and the environment. While each pesticide review is unique, all pesticides go through the same basic registration review process.

If a new assessment of the pesticide and additional data are needed to conduct the review, EPA issues a Data Call In (DCI).

Data protection

To protect the interests of registrants, EPA protects data used for pesticide registration in ways that depend on the type of data.

• Exclusive Use Data

Data submitted after September 30, 1978 to the Agency in support of the initial registration of a new active ingredient, a new combination of active ingredients, or in support of an application to amend the original registration to add a new use.

These data have “exclusive-use” protection for a period of 10 years after the date of the initial registration. The Agency cannot consider these data in support of an application for registration or amendment to a registration unless written authorization from the original data submitter is obtained authorizing the Agency to use these data to support the application.

• Compensable Data

Compensable data are data submitted to support an application (including reevaluation and DCI data) and no longer retain exclusive-use protection.

These data have a 15-year compensatory period beginning on the date the data were originally submitted to EPA. As long as the applicant/registrant relying on these data has certified to the Agency that it has offered to pay compensation to the original data submitter(s), the Agency may, without the permission of the original data submitter, consider these data in the registration review.

• Other Data

Besides these two categories. All other data including public literature articles, government-generated studies, and data for which all periods of exclusive use and compensation have expired, may be cited by an applicant without permission or an offer of compensation.

Our Services

• Company and Establishment Number Registration
• Submit an Initial Report and Annual Report
• Federal Pesticide Registration
• State Registration
• Pesticide Data Compensation Assessment
• Pesticide Device Registration
• Minimum Risk Pesticide Compliance
• Inert Registration
• Annual Service of US Agent
• Data Compensation Strategy and Data Holder Negotiation
• Data Assessment/Gap Analysis/Exemption Analysis
• Compliance Analysis Report of Pesticide Registration
• Comprehensive Regulatory Consulting and Training Services

Why Choose Us?

• Profound experience: professional tracking and studying the US EPA pesticide management regulations for many years, REACH24H is the US EPA official recommended compliance agency.
• Outstanding performance: By November 2021, REACH24H has successfully helped hundreds of domestic and foreign enterprises to submit EPA applications, completed more than 150 projects, and has the successful registration experience of EPA field pesticides, antibacterial pesticides and biological pesticides.
• Strong technical strength: with analytical chemistry, chemical engineering, biology, pharmacology, environment and other professional background of senior technical personnel composed of a strong team; It has a number of internationally certified toxicologists and risk assessment experts.
• International service level: with English, Chinese, Korean, Japanese, Spanish, German and other language abilities of customer service staff, efficient service to international customers.
• Rich accumulation: in many years engaged in pesticide and disinfectant regulatory response and technical advisory services have accumulated rich experience.
• Superior resources: to cooperate with many excellent laboratories at home and abroad, to design professional and efficient test programs for enterprises, to provide quality services.
• Good relationship channels: establish long-term friendly communication channels with EPA officials, associations and experts to significantly improve service quality and efficiency.

Compliance Solutions

Case Show: EPA Pesticide Registration

Case 1: Chinese pesticide enterprises have developed rapidly in recent years, and many of their superior products have reached the world’s leading level. As an OEM factories of foreign customers, pesticides have been exported to the United States, but due to a lack of registration certificates and initiative in trade, sales profits are limited. After receiving the requirements of enterprises, based on years of compliance experience, REACH 24H immediately analyzed the compliance status of different pesticide products, estimated data compensation costs, and issued customized compliance programs for enterprises. In the selection of the registration scheme, we try to use identical and similar registration, citing the data of the protection period and other methods, and try to reduce the cost of registration and save the registration cycle. The registration scheme has been unanimously recognized by enterprises, and the follow-up registration work has been carried out smoothly.

Case 2: Since it was punished by EPA for the first time in 2018, Amazon has strengthened supervision on the sale of pesticide products through e-commerce channels, such as mosquito repellent bracelets and other pesticides with the lowest risk, which has affected many manufacturers and forced them to remove their products from the shelves. After receiving the inquiry from the enterprise, REACH 24H quickly formulated strategies. On the one hand, he issued an exemption statement for the enterprise to adjust the product label, and on the other hand, he actively communicated with Amazon to convey the compliance requirements of EPA for the registration of the lowest risk pesticide exemption. As a result of our efforts, enterprise products are back on the shelves.