March 14, 2016

FSMA UPDATE: U.S. Food Safety Laws Overhauled

The FDA’s Food Safety Modernization Act (FSMA), the most comprehensive reform of the United States food safety laws in more than 70 years, was signed into law on January 4, 2011.  Following a nearly five-year rulemaking process, five of seven major FSMA rules are now effective.  These five rules addressing key food safety areas include:

•   Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule)

•   Current Good Manufacturing Practice (CGMPs) and Hazard Analysis and Risk-Based Preventive Controls for Human Food (HARPC) (Preventive Controls or PC Rule)

•   Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP Rule)

•   Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party Accreditation Rule)

•   Current Good Manufacturing Practice (GMPs) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Food for Animals (Preventive Controls Rule for Animal Food)

Food defense and sanitary transportation will be covered by two additional rules expected to be published before the summer.  How these major rules will impact Western Growers’ members depends on their size, commodities produced, type of operation and activities conducted.  We recognize that navigating through many pages of regulations can be overwhelming; therefore, we are developing resources and providing educational opportunities for members to understand these rules, implement them as applicable and meet compliance dates.  Although enforcement of the now effective rules will only begin in September 2016, it is in the best interest of affected entities to determine whether they are exempt, subject to modified requirements or covered by all rule provisions to prepare accordingly.

Western Growers staff have been primarily focused on two rules: the Produce Safety Rule and the Preventive Controls Rule for Human Food.  Questions we most often hear are:

•   Is my operation subject to one or more of the FSMA rules?

•   Which provisions of the rules apply to my operation?

•   How close or far is my operation from reaching compliance?

•   When do I have to be in compliance or when will the FDA inspect my operation?

Specialty crop producers, harvesters, packers and handlers are subject to the Produce Safety Rule with the following exceptions:

•   The farm’s produce annual sales are less than $25,000.

•   The produce receives commercial processing.

•   The produce is rarely consumed raw.

•   The produce grown is destined for personal or farm consumption.

The extent to which an operation will be affected by the Produce Safety Rule depends greatly on the farm size and annual sales.  In addition, depending on current food safety culture and practices, covered farms may either have to make minimal or major adjustments to their operations in order to be in compliance with this rule.  Although subject to the Produce Safety Rule, farms are not required to register with the FDA.  When a farm conducts certain activities outside of the farm definition (primary production farm and secondary activities farm), it becomes a mixed-type facility required to register with the FDA and partially or fully subject to the Preventive Controls Rule.

In general, activities performed by fresh-cut operations are considered processing/manufacturing and are covered by the Preventive Controls Rule.  If a fresh-cut processor currently operates under a Hazard Analysis and Critical Control Point (HACCP) plan, they are likely to need minimal adjustments to their current food safety programs or systems, although they may need to reevaluate their plan to address new provisions in this rule.  On the other hand, those facilities unfamiliar with HACCP or not operating under CGMPs or a food safety plan may need to perform extensive work to be in compliance.  No matter where companies find themselves on the spectrum of preparedness, Western Growers is committed to providing timely and adequate resources to assist members to meet the requirements of these new rules by the applicable compliance dates. In a proactive manner, Western Growers has launched an online FSMA portal containing tools and guidance that will be updated periodically as new materials become available.

Additionally, the FDA has developed a Technical Assistance Network (TAN) to address specific questions from industry, regulators, academia, consumers and others regarding FSMA rules implementation.  According to the agency, these questions will inform the development of forthcoming guidance documents for the industry expected to be available when compliance dates are in effect.

The Western Growers’ FSMA Portal can be accessed at:

The FDA’s TAN can be accessed at: