FDA Finalizes Produce Safety Rule

The FDA Food Safety Modernization Act (FSMA) Produce Safety rule first proposed in January, 2013, is now final.[1] The rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.[2]

Subsequent to the rule proposed in 2013, a supplemental notice of proposed rulemaking was issued by the FDA in September 2014. The final rule is a combination of the original proposal and revisions outlined in the supplemental proposal.[3]

Key requirements under the final rule include criteria for: the quality of water used for crop irrigation (confirmed through testing); biological soil amendments addressing the application of raw manure and stabilized compost; and requirements to help prevent the contaminations of sprouts.[4] In addition, the final rule also addresses concerns about the “feasibility of compliance for farms that rely on grazing animals (such as livestock) or working animals for various purposes.”[5] Worker training, health and hygiene requirements are also set forth in the final FSMA, as are standards related to equipment, tools and buildings meant to ensure adequate sanitation and preventing contamination of produce.[6]

The final rule provides for exemptions, as well as a variance process for those qualifying for the same. Compliance dates are established based on the size and/or type of the affected farming operations, with the earliest of the compliance dates coming as soon as one year from the effective date of the new rule.

For more information about the possible effects the FSMA is likely to have on your farming operations, please contact Anna H. Long in our Orlando office: ALong@www.deanmead.com.

About the Author:
Anna H. Long is a member of Dean Mead’s Agribusiness and Real Estate Development Industry teams. She has been practicing law for over 30 years in the areas of environmental law, land use, zoning and administrative law. Before moving to private practice, Ms. Long held numerous environmental managerial positions throughout Florida and the Northwest. She may be reached at Along@www.deanmead.com.


[1] FDA, U.S. Food and Drug Administration, FSMA Final Rule on Produce Safety, (November 16, 2015), http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

[2] Id.

[3] Id.

[4] Id.

[5] Id.

[6] Id.