The 10 Steps to the Subregistration Process 

Introduction

Successfully navigating the intricate web of EPA pesticide registration and subregistration is crucial for manufacturers and distributors aiming to expand their market reach. Also called "Supplemental Registrations", "White Labeling", or "Distributor Product", subregistration allows you to distribute an already registered pesticide product under your own brand name, offering a streamlined path to market entry. Our comprehensive guide outlines the key steps and considerations involved in the subregistration process, ensuring your compliance and success.

What is a Subregistration?

Subregistration, a pivotal aspect of pesticide product registration, permits a distributor to sell an EPA-registered pesticide product under their own branding. This process requires the original product registrant's permission and adherence to specific regulatory guidelines. Subregistration is essential for businesses looking to diversify their product lines without undergoing the full registration process independently. This service is integral to our pesticide regulatory consulting and compliance offerings, helping you achieve EPA pesticide registration efficiently.

A link to Chapter 9 of the EPA Manual which describes Subregistration:
https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-9-supplemental-distribution-registered#requirements 

Steps to EPA Pesticide Subregistration

EPA pesticide subregistration allows a distributor to sell a registered pesticide product under their own brand name. Here’s a step-by-step guide to the process:

1. Identify the Registrant

Ensure that the primary registrant (original manufacturer) has agreed to allow subregistration. Subregistration is only possible with the permission of the original product registrant.

2. Obtain a Letter of Authorization

The original registrant must provide a letter of authorization, granting you permission to subregister their product. This letter should outline the terms of the agreement and confirm that the subregistered product will be identical to the original. 

Note! The Letter of Authrorization will also be required during state registration.

3. Prepare Your Product Label

Develop a product label that complies with EPA guidelines. The label must include:

• • The product name (can be different from the original).

  • The phrase “Distributed by” followed by your company's name and address.

  • All required cautionary statements, usage instructions, and the original product's EPA registration number followed by a dash and the subregistration number.

Ensure the label accurately reflects the original product’s use and safety information without making additional claims.

Reminder! Many of the original manufacturer's label components will need to be transferred to the new label verbatim

4. Submit Form 8570-5: Notice of Supplemental Distribution of a Registered Pesticide Product

Complete EPA Form 8570-5, which notifies the EPA of the intent to subregister a product. This form requires:

• • Information about the primary registrant and the subregistrant.

  • Details about the product being subregistered.

  • The original product’s registration number.

5. Include Required Documentation

Along with Form 8570-5, include the following:

• • The letter of authorization from the primary registrant.

  • Two copies of the proposed label for the subregistered product.

6. Submit the Application

Send the completed form, letter of authorization, and proposed label copies to the EPA’s Office of Pesticide Programs (OPP). Electronic submission may be available through the EPA’s Pesticide Submission Portal.

7. EPA Review Process

The EPA will review your submission to ensure compliance with all regulations. This includes verifying that the subregistered product’s label matches the original product's label in terms of safety and efficacy.

8. Receive EPA Approval

Once the EPA approves the subregistration, you will receive confirmation and an EPA registration number for the subregistered product. This number will be the original product’s number followed by a unique subregistration code.

9. Complete State Registration

Once you are EPA approved, it is still required to conduct product registration with each state. 

Suggestion: If you have questions or need guidance or would prefer to have the work handled by specialists, USA Pesticide Registration's team of experienced and qualified specialists can help.

10. Begin Distribution

After receiving approval, you can begin distributing your subregistered product. Ensure ongoing compliance with all EPA regulations and maintain clear records of your subregistration.

Conclusion

The EPA subregistration process allows distributors to market pesticide products under their own brand while ensuring compliance with federal regulations. By following these steps and leveraging expert guidance from a pesticide registration consultancy, you can streamline the process and successfully bring your subregistered products to market. 

Contact us for more detailed assistance and support throughout your subregistration journey.