How to Prepare Product Labeling for an EPA Label Review

The U.S. Environmental Protection Agency (EPA) label review process plays a crucial role in ensuring that pesticide products are used safely and effectively. These product label reviews are an essential part of the regulatory process before a pesticide can be registered and marketed.

Understanding the Pesticide Label Review Process

In the U.S., toxic or hazardous substances are regulated under various laws. Pesticides are covered by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As part of this, an EPA label submission and review is necessary during the registration of a pesticide or any device with pesticidal claims. Additionally, individual states may have their own label requirements, which leads to products being marketed with unique labels specific to a state.

When a registrant submits a label for registration, the EPA’s Office of Pesticide Programs (OPP) begins a thorough review of the Master Label and its accompanying information. [1] The primary goal of this review is to ensure safe and legal handling of the pesticide, thereby protecting human health and the environment. It also ensures compliance with regulatory standards, promoting trust among users and handlers.

During the label review process, the EPA evaluates the label for features such as clarity, accuracy, and consistency with EPA label requirements. Moreover, the Master Label must be legally enforceable, meaning that if a violation occurs, the EPA could prosecute based on the label.

How to Prepare Your Master Label for an EPA Label Review

Since multiple documents are required for the label review, efficient document management is crucial for achieving EPA compliance. Detailed checklists help ensure that all necessary materials are properly gathered and submitted. Effective workflows and quality systems at the document level are necessary to ensure that both the content and label formats (e.g. font size and layout) are compliant and complete.

Understanding Labeling Guidelines

To prepare a product label for EPA review, it is essential to understand the specific labeling requirements under EPA regulations. A product label functions as a legal document, providing key information about the product’s contents, usage, hazards and safety precautions.

For example, labels must include appropriate signal words like “CAUTION”.   Safety and health portions of pesticide labels must also appear in Spanish on the label or via a scan-able link. This is being phased in from 2025 to 2030. Requirements vary significantly depending on the product’s toxicity category and other factors.

Consulting the EPA before submitting a label is highly recommended. A label typically consists of two main parts: the front panel (with eight components) [2] and the back panel (with four components). [3] The EPA’s Label Review Manual [4] checklist provides insight into potential errors. Common ones include incorrect font size or placement of elements, which could lead to a failed review or delays in approval.

Make Use of EPA Resources for Regulatory Review

The EPA offers various online resources to assist registrants with label review submissions, including:

• Label Review Manual: A comprehensive guide originally developed for EPA reviewers, now designed for registrants. [5]
• Pesticide Label Review Training: Five free training modules covering the content of the Label Review Manual. [6]
• EPA Regulatory Website: Main portal, including access to laws and regulations, also with links for state-specific requirements. [7]
• Pesticide Registration Guidance: Key documents and links for registration. [8]
• Pesticide Product Label System (PPLS): A tool to search approved labels for similar products. [9]
• EPA links to external sources: Focused on the specific laws and regulations [10]

Best Practices for Label Review for an EPA Label Review

1. Assign clear roles for label submission: Ensure that experts familiar with regulations and guidelines are in place to communicate within the project team.
2. Ensure appropriate training: Team members must be trained and have easy access to necessary resources, like the Label Review Manual.
3. Submit complete and accurate documents: A draft Master Label containing all potential uses and associated labeling requirements from each potential state should be provisionally approved by the EPA before submitting the final printed version.
4. Use EPA-approved labels as a guide: Utilize the PPLS tools to find labels for similar products and use these as a reference for compliance.
5. Implement excellence in proofreading practices: Use digital files, automated proofreading, and e-submission options to ensure error-free labels.

Drafting and Designing Your Label for Submission

Compliant label drafting involves meeting content and formatting requirements for both the front and back panels, including the product name, net contents, and active ingredients. Clear, concise usage instructions, safety handling, along with hazard and precautionary statements, are vital for ensuring the product is used safely and effectively.

Consistency between the product label and accompanying documentation is critical. While aesthetic considerations like layout, font, and color enhance readability, ensure that the design remains compliant with EPA standards. Well-designed labels that meet these standards not only facilitate regulatory approval but also improve the product’s marketability.

Submitting Your Label for Regulatory Review

Label reviews can be submitted through the EPA’s Pesticide Submission Portal (PSP) [11], which streamlines the process for digital submissions. Although paper submissions are allowed, electronic submissions are preferred for efficiency. Live PDF documents are easier to store, search, and track in databanks.

Upon submission, a designated person within the EPA coordinates the registration and acts as the liaison between the EPA, the registrant, and the public. [12] To avoid delays, registrants must meet all key deadlines, including those associated with expedited reviews or resubmissions. Tracking submission timelines is essential, as label reviews can take several months or years depending on product complexity.

Submitting a draft Master Label electronically for provisional review is recommended. The EPA typically provides feedback, such as requests for clarification or revisions. Addressing these comments promptly is key to ensuring timely approval. Furthermore, registrations must be reviewed at least every 15 years to reassess pesticide effectiveness and risk to human health and the environment. [13]

EPA Decision Review Timeframes

The Pesticide Registration Improvement Act (PRIA) outlines fees and decision timeframes for product registrations. These timeframes vary based on several factors, including whether the active ingredient is conventional or antimicrobial, new or already registered, whether the product is for food or non-food use, indoor or outdoor, and more.

For instance, a product with a new active ingredient for food or non-food use has a decision timeframe of 24 months (Action Code R010), while “me-too” products with identical or similar active ingredients and uses have a decision timeframe of four months. The EPA has an excellent decision tree page to help you work out your decision timeframe. [14]

In 2023, the EPA registered three products with an Action Code R010 (new active ingredient) with an average delay of 633 days beyond the specified timeframe. However, it performed better on “me-too” products, with an average delay of 82 days [15].

Maintaining Regulatory Compliance

Once a product is registered, it is crucial to ensure ongoing compliance with EPA regulations. Registrants must stay updated on changes to EPA guidelines, which can evolve based on new scientific data. Regularly reviewing product labels and keeping them aligned with current standards – especially safety warnings and usage instructions – is essential.

Additionally, registrants must report any adverse events related to product use, such as environmental or health issues. The EPA may conduct compliance audits, making it essential to maintain accurate records.

Tips for a Smooth Regulatory Review Process

To ensure a smooth label review process, address common issues like incomplete submissions or inconsistent documentation. Proactive steps, such as consulting the EPA about submission requirements, using EPA checklists, and seeking assistance from regulatory consultants, can streamline the process.

Ensure clear communication with the EPA product manager, and always submit draft labels electronically for provisional review. Monitoring and promptly responding to EPA feedback is key to avoiding delays.

• Understand EPA Requirements: Consult the EPA in advance
• Use EPA’s Label Review Manual and training modules
• Ensure Accurate Product Information
• Be Clear and Concise: Keep text simple, avoiding unnecessary complexity
• Submit drafts, using electronic submission
• Respond Promptly to EPA Queries: Address any questions or deficiencies raised by EPA quickly to avoid delays.
• Monitor and review EPA updates and guidance documents.

Leverage Personal Assistance for Label Submissions

If your organization doesn’t have the inhouse competencies to navigate EPA label review submissions, consider engaging consultants or regulatory advisors with experience in your industry. These experts can provide valuable guidance, streamlining the submission process and enhancing compliance.