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The US Food Safety Modernization Act (FSMA) rule for “Mitigation Strategies to Protect Food Against Intentional Adulteration” (or simply, the intentional adulteration rule) is aimed at protecting the US food supply against acts intended to cause wide-scale harm to public health.

The intentional adulteration rule is a major breakthrough, since it provides a regulatory framework for food defense, while keeping it at a practical level, covering the requirements of food defense plan, training and record-keeping (See Figure 1). The rule is covered under 21 CFR Part 121, as follows:

  • General provisions: Applicability, Definition, Qualification of individuals performing activities for prevention of intentional adulteration (Subpart A)
  • Food Defense Measures: (Subpart C)
  • Record keeping requirements (Subpart D)
  • Compliance (Subpart E)

The intentional adulteration rule applies to both domestic and foreign companies required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has set compliance dates for the rule as follows:

  • Very small businesses – those businesses (including any subsidiaries and affiliates) averaging less than $10,000,000 in sales of human food – July 26, 2021
  • Small businesses – those employing fewer than 500 persons – July 27, 2020
  • All other businesses – July 26, 2019

The rule also offers exemptions and modified requirements for certain categories, namely:

  • Small businesses are exempt, but would be required to provide upon request, documentation to demonstrate that the business is very small
  • Holding of food, except the holding of food in liquid storage tanks
  • Packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact
  • Activities that fall within the definition of “farm”
  • Manufacturing, processing, packing, or holding of food for animals
  • Alcoholic beverages (under certain conditions)
  • Certain categories of on-farm manufacturing, processing, packing, or holding of foods
Food Defense Plan inforgraphic

Food defense guidelines and criteria have been around for many years, and are expected to gain new momentum with FSMA. PAS 96 and other schemes have taught us best practices in preventing intentional adulteration, and now FSMA creates an environment for food defense practices to grow and evolve within a sustainable system focused on preventing potential attacks.

A Practical Approach

Best practices have taught us that implementing a corporate initiative such as food defense is best achieved with a multidisciplinary team. One which should be responsible for planning, implementing and ensuring the effectiveness of the system.

The intentional adulteration rule requires facilities to develop a food defense plan which is based on assessing vulnerabilities in a facility’s food system against potential attacks – both internal and external. As a starting point, the facility needs to identify the steps of its food system, in order to conduct an assessment of each step and pinpoint system vulnerabilities and critical areas. In FSMA, those areas are called Actionable Process Steps. These steps require remedies, or as the regulation calls them “mitigation strategies”.

Once mitigation strategies are set, the facility is then required to have documented monitoring systems in place. Facilities will have a variety of monitoring methods to choose from, depending on their own systems, products and facility specifics. While in some facilities basic monitoring systems such as visual checks and random inspections may prove effective, others may opt for IT solutions, secondary intrusion detection systems, etc. There are also verification requirements in FSMA. These would also be specific to each facility. Random sampling and testing, audits, mock intrusions or any other verification measure chosen by the facility would need to be documented. Other requirements include system reanalysis, records control and training.

Training

The FSMA rule for Mitigation Strategies to Protect Food Against Intentional Adulteration has set specific requirements for training.

Individuals working at actionable process steps and supervisors of actionable process steps must be trained in food defense awareness and have the appropriate education, training, or experience (or a combination thereof) to ensure they will properly implement the mitigation strategies at the actionable process steps.

There are also qualification requirements for supervisory personnel and individuals performing specific job duties, namely:

  • Food defense plan preparation
  • Vulnerability assessments
  • The identification and explanation of mitigation strategies
  • Reanalysis

Success Factors

Best practices and industry experience have demonstrated that an effective food defense journey starts with a robust, multidisciplinary food defense team. Also, existing food defense procedures and documentation whether for PAS 96, GFSI or other schemes can certainly be of great help in facilitating compliance. However, each facility has its own characteristics, unique vulnerabilities and therefore food defense plans should be tailored to the facility.

Food defense is an on-going process as new means and threats are discovered every day. Any potential attack with the intention to cause public harm, whether external or internal, should be addressed and mitigated.

Training is a key requirement and a critical success factor in creating awareness and building organizational capacity to develop and maintain a robust food defense system.

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For further information, please contact:

Hank Karayan
Global FSMA Program Director
t: +1 (201) 508 3000