Meeting Critical Food Safety Deadlines

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Meeting Critical Food Safety Deadlines

By Stephanie Barnes, Regulatory Counsel, FMI - 01/01/2015

The FDA Food Safety Modernization Act (FSMA) was designed to improve and modernize the country's food safety system and provide the U.S. Food and Drug Administration (FDA) with the necessary tools and authority to protect our food supply. Within this set of sweeping laws, comprised of 1,200 pages of proposed final rules, come greater responsibilities for food retailers and wholesalers regarding prevention, detection and imports.

A number of the provisions of the law impact food retailers and wholesalers including the sections related to mandatory consumer notification of recalls, third-party auditing, sanitary food transportation and hazard analysis and preventative controls. FMI works closely with the FDA as the agency implements FSMA regulations and the table below summarizes the key requirements and dates with which food retailers must comply.

Major FSMA Regulations and Compliance Dates

Preventive Controls on Human Food
Key requirements: Facilities are currently required to register with FDA (food facilities are covered under this rule), which includes facilities that manufacture, process, pack and hold food. The rule includes distribution centers but does not include retail stores.
Court-Ordered Final Rule Deadline: 8/30/2015
Compliance Date: 8/30/2016

Preventive Controls on Animal Food
Key requirements: Applies to manufacturing, processing, packing and holding of animal food. The rule establishes current good manufacturing practices for animal food and creates new preventive controls provisions.
Court-Ordered Final Rule Deadline: 8/30/2015
Compliance Date: 8/30/2016

Produce Safety
Key requirements: Establishes minimum standards for safe growing, harvesting, packing and holding of produce on farms. It applies to both domestic and imported produce with several exemptions.
Court-Ordered Final Rule Deadline: 10/31/2015
Compliance Date: 10/31/2016

Foreign Supplier Verification Program
Key requirements: Requires all importers to establish a program to verify that imported food:

  1. Is produced in compliance with the preventive controls rule (or standard that provides same level of public health protection);
  2. Is produced in compliance with produce safety rule (or standard that provides same level of public health protection);
  3. Is not adulterated;
  4. Is in compliance with allergen labeling requirements; and
  5. a supplemental proposed rule allowed for a hybrid of option-1 and option-2 based on the hazards in the product.

Court-Ordered Final Rule Deadline: 10/31/2015
Compliance Date: 10/31/2016

Third Party Certification of Auditors
Key requirements: FSMA Sec. 307 directs FDA to set up a system for recognizing bodies to accredit third-party auditors to conduct audits for purposes of the Foreign Supplier Verification Program. It is not a blanket regulation of all third-party auditors, only those that choose to opt-in.
Court-Ordered Final Rule Deadline: 10/31/2015
Compliance Date: 10/31/2016

Sanitary Food Transportation Act
Key requirements: Establishes criteria and definitions that would apply in determining whether food is adulterated because it has been transported or offered for transport by a shipper, carrier by motor or rail vehicle, or receiver engaged in the transportation of food.
Court-Ordered Final Rule Deadline: 3/31/2016
Compliance Date: 3/31/2017

Food Defense
Key requirements: Implements provisions of the Food, Drug and Cosmetic Act as they apply to intentional adulteration. It applies to domestic and foreign facilities required to register under section 415 of the Bioterrorism Act; distributions centers are generally exempt.
Court-Ordered Final Rule Deadline: 5/31/2016
Compliance Date: 5/31/2017

For a detailed look at FSMA resources in addition to an online portal to submit your specific questions, visit www.fmi.org/fsmaresources