U.S. EPA Establishment Requirements for Pesticides and Related Devices

Do I Need an Establishment Number?

10 August 2021

To be fully compliant with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), producers and distributors of pesticides and pesticide devices in the United States (U.S.) must meet all requirements of the Act. Section 7 of FIFRA requires that production of pesticides, active ingredients, or pesticide devices be conducted in a registered establishment. Under FIFRA, production includes:

  • Formulation of a pesticide or active ingredient;
  • Manufacturing of a pesticide device;
  • Packaging or repackaging a pesticide or pesticide device; and
  • Labeling or relabeling a pesticide or pesticide device.

Obtaining an Establishment Number

Any facility involved in the production of pesticides or pesticide devices must be registered with the U.S. Environmental Protection Agency (EPA) by the owner of the facility to obtain an establishment number. Under FIFRA, the labels of pesticide and pesticide device must bear an establishment number. The full labeling requirements for pesticides and pesticide devices can be found in Title 40, Code of Federal Regulations (40 CFR) Section 156.10. If the product was produced at more than one establishment, the establishment number of the facility where the last production activity occurred must appear on the label.

Establishment numbers can be obtained using the U.S. EPA's Central Data Exchange (CDX) electronic reporting site.

Reporting Requirements

A report is due annually by March 1st from each registered establishment. An initial report for the previous calendar year must be submitted by all new establishments within 30 days of the establishment number assignment. For each pesticide or pesticide device produced at the establishment, the following information is required:

  • Amount produced in the previous calendar year;
  • Amount sold and distributed to the U.S. in the previous calendar year; and
  • Estimate of the amount to be produced in the current year.

This reporting can also be completed through CDX. If an establishment is no longer producing pesticides or pesticide devices, the establishment can be terminated so that annual reports will no longer be required.

Conclusion

If you are involved in the production of pesticides or pesticide devices, it is important to understand the U.S. EPA requirements for establishments to ensure your facility is compliant with FIFRA. Do you have questions about this topic, labeling and registration requirements for pesticides and pesticide devices, or a related topic? Do you need assistance preparing a federal registration dossier for a pesticide or state registration applications for a pesticide or pesticide device? Contact our experts at Intertek. We're here to help!

References:

FIFRA Section 7: https://www.govinfo.gov/content/pkg/USCODE-2011-title7/html/USCODE-2011-title7-chap6-subchapII-sec136e.htm

U.S. EPA Central Data Exchange: https://cdx.epa.gov/

40 CFR 156.10: https://www.govinfo.gov/content/pkg/CFR-2011-title40-vol24/pdf/CFR-2011-title40-vol24-sec156-10.pdf

Michaela Marshall,
Associate II, Chemicals Group

 

Today's expert blogger is Michaela Marshall. Michaela is an Associate II in Intertek's Chemicals Group. As part of the biocides team, she assists clients with the regulatory requirements for pesticides and pesticide devices in Canada and the United States. This includes product registrations, label reviews, and other regulatory support to comply with the PMRA and U.S. EPA regulations. Michaela holds a M.Sc. in Environmental Chemistry from the University of Toronto.