FDA changes FSMA compliance dates and publishes draft guidance

By Joseph James Whitworth contact

- Last updated on GMT


Related tags: Food

The US Food and Drug Administration (FDA) has extended and clarified compliance dates for certain parts of rules within the Food Safety Modernization Act (FSMA).

The action affects four of the seven rules – the two CGMP and Preventive Controls rules for human and animal food, Foreign Supplier Verification Programs (FSVP) and Produce Safety. More details can be found in the Federal Register notice​.

The first major compliance dates begin next month for large food facilities.

Compliance dates approaching

Human food companies other than small and very small businesses will need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by September 19 this year.

Changes include providing more time for manufacturers to meet requirements related to assurances their customers must provide, for importers of food contact substances and other extensions to align compliance dates for other food operations or provide time for FDA to resolve issues.

The rule also clarifies that farms subject to the Produce Safety rule have discretion in how they sample agricultural water to develop a microbial quality profile.

It provides an additional two years to comply with the customer assurance requirements while FDA considers the best approach to address concerns.

Compliance dates for these requirements are different for each rule, with the earliest being September 19, 2018 for large human food facilities.

Importers subject to the FSVP rule have an additional two years to meet the requirements for importation of food contact substances. The earliest compliance date is May 28, 2019.

Draft guidance for different areas and rules

FDA also issued draft guidance​ to help industry comply with the Preventive Controls for Human Food rule (deadline 21 February 2017).

The text involves five chapters of what will be multi-chapter guidance designed to help businesses comply with the CGMP and Preventive Controls for Human Food Rule.

It explains FDA’s thinking on how to comply with requirements for hazard analysis and risk-based preventive controls and includes establishing a food safety plan.

The agency plans on releasing all chapters of this work by early 2018.

FDA also published draft guidance​ to assist businesses in determining whether they fall within the “farm” definition.

Businesses that perform activities within the “farm” definition are not subject to the Preventive Controls for Human Food or Animal Food rules. Instead, when activities involve covered produce, farms may be subject to the Produce Safety rule.

Facilities operating outside the farm definition generally need to register with the FDA as food facilities (unless other exemptions apply) and may be subject to the Preventive Controls for Human Food or Animal Food rule.

Another draft guidance​ is intended to help facilities that manufacture, process, pack or hold animal food that will be eaten in the US to comply with CGMP requirements in areas such as plant and grounds, sanitation, equipment and utensils, plant operations and holding and distribution.

It also includes information on training and related recordkeeping. The CGMPs required under the Preventive Controls for Animal Food rule address the diversity of facilities and animal foods, the range of animal food activities and the potential safety risks posed by some animal foods.

Grant Award for tribes and local food producers

FDA has also announced grant awards to develop training options for local food production systems and tribal operations.

The Local Food Producer Outreach, Education and Training to Enhance Food Safety and FSMA Compliance cooperative agreement went to the National Farmers Union Foundation.

The Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance cooperative agreement was awarded to the University of Arkansas.

Awards will provide one year of support at $1.5m for the local food agreement and $750,000 for the tribal agreement and each includes recommended support for two additional years.

Related topics: Food Safety & Quality

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