Introduction

The process of registering a pesticide is a scientific, legal, and administrative procedure where EPA examines the ingredients of the pesticide; the particular site or crop where it is to be used; the amount, frequency, and timing of its use; and storage and disposal practices. In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product. The company that wants to produce the pesticide must provide data from studies that comply with specific testing guidelines. This Fact File outlines some common errors made by organizations when submitting data for pesticide registration so that your business can avoid making the same mistakes.

Background

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides for federal regulation of pesticide distribution, sale, and use, and requires all pesticides sold or distributed in the United States (including those that are imported) to be registered by EPA. Procedures for submitting a complete application for registration of a pesticide product are detailed in regulations at 40 CFR 152.40–152.55, and Pesticide Registration (PR) Notice 11-3 discusses both the recommended and the required procedures for submitting FIFRA data. EPA has also published the Pesticide Registration Manual as a resource for companies and individuals who want to have their pesticide products registered for sale in the United States.

Common data submission errors

The process of registering a pesticide is complex, and due diligence is essential throughout the application and data submission process. Many organizations falter when it comes to clerical errors in their data submissions — although a mistake may seem small, it can delay or altogether derail an organization’s registration efforts.

In an analysis conducted by the Office of Pesticide Programs (OPP), EPA identified common formatting errors of submitted data. These common errors included:

• Incorrectly formatted Confidential Business Information Statement.
• Missing or incomplete Good Laboratory Practice (GLP) Standards Compliance Statement. · Incorrect pagination.
• Legibility problems.
• Unsigned documents.

Certain forms have been identified that are often missing from the data submission, including the:

• Certification of Data Compensation statement.
• Formulator’s Exemption statement.
• Data Matrix Form.

Specific problems with Data Matrix requirements include failure to include all required generic and product-specific data and citing incorrect Master Record Identification (MRID) Numbers. MRIDs are unique eight-digit numbers that are assigned to each study that is submitted to EPA.

Additional Tip: Following the instructions in PR Notice 11-3 is essential. Taking the time to ensure that data submissions follow these formatting guidelines will avoid rejection of the application during the 21-day initial content review.

A Final Note: An application will be rejected if the required three copies of the data are not properly bound and formatted or the electronic submission does not follow Agency guidance.

Applicable laws & regulations

40 CFR 152 – Pesticide Registration and Classification Procedures

40 CFR 155 – Registration Standards and Registration Review

40 CFR 156 – Labeling Requirements for Pesticides and Devices

40 CFR 162 – State Registration of Pesticide Products

Related definitions

“Pesticide” means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant.

“Labeling” means the label on a pesticide product as well as any printed or written material that accompanies the product (for example, a booklet or manual). Labeling can also include material to which the label (or other labeling material) refers.

Key to remember

FIFRA data submission is a key step in pesticide registration, as it allows EPA to conduct effective ecological, human, and cumulative risk assessments before approval. Relatively minor errors in data submission can result in the rejection of an application.

Real world examples

While pesticide registration can be complicated, the consequences of failing to comply with the requirements can be extremely costly for organizations … seven-figure penalties are not unusual. One company in Northfield, IL, agreed to pay a $4,930,000 administrative penalty for numerous alleged violations of FIFRA through the selling or distribution of an unregistered pesticide. Another organization that imported devices containing an unregistered component that made pesticidal claims faced an even steeper civil penalty of $6,991,400.

EPA takes violations of pesticide regulations very seriously. Ensure that your organization follows the proper registration procedures — a little extra work up front could end up saving millions of dollars.