What’s New in FSMA? – Overview of FSMA 7 Rules.

Food Safety Modernization Act (FSMA) was signed by President in 2011, passed by Congress in 2013 and published by FDA starting September 2015. This massive food safety regulation was published in pieces and specifies 7 rules covered under FSMA.

One of the first parts of FSMA regulation were Current Good Manufacturing Practices and Risk Based Preventive Controls for Human Food (PC Rule for short) 21 CFR 117. The PC Rule requires that businesses that manufacture, process, pack or hold food have a Preventive Controls Qualified Individual (PCQI) available. PCQI is responsible for the development, implementation, and maintenance of a food safety system with all responsibilities that come with it i.e., development of a food safety plan, identification of preventive controls for process, allergens, sanitation and supply chain, record review, verification activities, etc.

Simultaneously with PC Rule for Human Food, Preventive Controls for Animal Food Rule was published under 21 CFR 507. This regulation covers animal feed and animal food and requires similar types of controls as in human food regulation. The only difference is the lack of allergen preventive controls under PC for Animal Food Rule.

Soon after publishing the PC rules, FDA published the following parts of Food Safety Modernization Act:

  1. Produce Safety Rule that covers farms and requires them to identify, analyze and control biological hazards throughout farming operation. The rule covers growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption and specifies requirements for water, soil, sprouts, domesticated and wild animals, employee training, equipment, tools, and buildings.
  2. Sanitary Transport Rule that covers food transport and distribution companies and requires operations to be conducted in a manner that will protect food from adulteration and contamination. The rule specifies requirements for vehicles and transportation equipment, transportation operation, employee training and records.
  3. Accredited 3rd Party Certification Rule. This rule is voluntary and establishes accreditation criteria for certification bodies that would conduct food safety audits of foreign facilities. Certification may be required if a foreign facility wish to participate in VQIP (Voluntary Qualified Importer Program) or if requested by the FDA. FDA may request such certification if they suspect certain food to likely be a public health concern.
  4. Foreign Supplier Verification Program that covers food importers. According to this rule food importers are primarily responsible for food safety of food imported from foreign countries. An importer is to assure that imported food meets the same level of food safety and public protection as food made in the US. Compliance with FSVP rule is demonstrated through records pertaining to hazard analysis of imported food and assessment of the foreign supplier.

The most recent FSMA rule is Intentional Adulteration Rule or Mitigation Strategies to Protect Food from Intentional Adulteration. This is the newest and the last of FSMA rules with compliance dates in July of 2020 and March of 2021 for small businesses. IA rule requires that companies use HACCP method to build their Food Defense Plans. It requires that all covered facilities conduct Vulnerability Assessment to identify significant vulnerabilities in their food operation – Actionable Process Steps (APSs). For each APS identified the rule requires mitigation strategies with management components such as monitoring, corrective actions, verification, and records.

Complying with Food Safety Modernization Act may be challenging, especially for small businesses but there are external resources available. In addition to training curricula developed by FSPCA companies can use Technical Assistance Network.

BD Food Safety Consultants offers FSPCA’s PCQI and FSVP training courses and IHA accredited HACCP certification courses. In addition to Training Programs our consulting service includes the development and implementation of plans and programs in compliance with FSMA regulations. Contact us today by visiting our website or emailing [email protected]