FSMA Files: Anatomy of FSMA - How Each Rule Applies to Almonds

Get your FSMA Facts straight from the experts. Almond Board of California has engaged a consulting firm whose lawyers have worked with FSMA since its beginning.  In this month’s FSMA Files column they answer your questions about which FSMA rules the almond industry needs to address.

Question: We often see the FDA Food Safety Modernization Act (FSMA) rules referenced in isolation, and it’s easy to lose sight of the big picture. Can you name each of the FSMA rules and explain how it applies to the almond industry?

There are 7 FSMA rules, but only 6 that the almond industry potentially needs to address, based on business structure and operations. They are as follows:

Produce Safety: Establishes federal food safety regulations for farms covering: agricultural water; biological soil amendments; worker hygiene and training; buildings, tools and equipment; growing, harvesting, packing and holding; and management of domesticated and wild animals.

Preventive Controls for Human Food: Requires facilities to conduct a hazard analysis and implement a food safety plan, with additional requirements existing around supply chain controls and employee training.

Preventive Controls for Animal Food: Is similar to the Preventive Controls for Human Food rule and establishes requirements for animal food that are relevant under two conditions: 1) If you are a facility that manufactures feed for animals or 2) If you’re a facility that sends human food byproducts (e.g. hulls/shells) for use as animal feed.

Sanitary Transportation of Human and Animal Food: Reflects longstanding industry best practices for food transportation and establishes requirements for vehicles and transportation equipment, records, training and waivers.

Intentional Adulteration: Outlines risk-reducing strategies to prevent intentional adulteration from acts intended to cause wide-scale public health harm and requires, for the first time, a food defense plan.

  • Applies to facilities including non-farm almond handlers and non-farm huller/shellers.
  • Next Compliance Deadline: July 26, 2019 for large businesses.

Foreign Supplier Verification Program: Requires importers to verify that their foreign suppliers have adequate programs in place to ensure the food coming into the U.S. meets food safety standards comparable to those in the U.S.

  • Applies to almond handlers that import ingredients directly from a foreign supplier (you are exempt from this rule if you purchase ingredients from a U.S. supplier).
  • Compliance Deadline: Began May 20, 2017 for all businesses.  
  • FSMA Fact Sheet: 

Accredited Third-Party Certification:  Establishes a voluntary program for the accreditation of third-party certification bodies/auditors to conduct food safety audits and issue certifications outside the U.S. It would only apply in two situations, neither of which affect the U.S. almond industry: 1) if you’re trying to be part of FDA’s Voluntary Qualified Importer Program or 2) if you’re importing food from a country for which FDA requires certification as a condition of import.

New resources to help the almond industry get up-to-speed on FSMA are now available on the grower and processor webpages. 

Please keep your questions coming! You can send them to Tim Birmingham at tbirmingham@almondboard.com with the subject line “FSMA Files.” 


ABC utilized input from Elizabeth Fawell and Maile Hermida, lawyers with Hogan Lovells US LLP in Washington, DC. in the preparation of this column. The FSMA Files column is provided for informational purposes only and does not constitute legal advice.  

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