FSMA Final Rules Issued for Mitigating Risk of Intentional Adulteration

Click here to learn about the FDA's final rules to prevent intentional adulteration of food products.

The FDA, in accordance with the directives of the Food Safety Modernization Act (FSMA) of 2011, recently issued final rules to prevent intentional adulteration of food products.  Such acts include food terrorism, sabotage by disgruntled employees, corporate sabotage, and more. It is now required that all registered food facilities develop risk mitigation strategies to reduce the negative effects such incidents might have on public safety and the vitality of the US food supply chain.

Who will this Affect?

This rule is designed to cover both domestic and foreign companies that are registered with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act.  It applies primarily to large companies whose products reach many people, exempting companies with smaller footprints. In total, there are 3,400 firms covered that operate 9,800 food facilities. The initial compliance date for the largest facilities is July 26, 2019.

Key Provisions of Food Defense Plan

The newly issued rules will build on Hazard Analysis Critical Control Point (HACCP) — a system the food industry is already utilizes for the identification, evaluation and control of food safety hazards. 

All covered facilities are required to prepare and implement a food defense plan. The written food defense plan must identify vulnerabilities & actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification.  The plan must be reanalyzed every three years or sooner if the strategies are determined to be inadequate or not properly implemented. 

Vulnerability Assessment

Identifying vulnerabilities and actionable process steps for all food manufactured, processed, packed or held at the food facility. Every point, step, or procedure in the facility’s process must be evaluated for the following:

  • The severity and scale of the potential impact on public health. This includes the volume of product, the number of servings, the number of exposures, how fast the food moves through the distribution system, potential agents of concern, the infectious/lethal dose of each, and the possible number of illnesses and deaths.
  • The degree of physical access to the product. This includes the presence of such physical barriers as gates, railings, doors, lids, seals, and shields.
  • The ability to successfully contaminate the product. [21CFR  121.130]

Mitigation Strategies for Actionable Process steps

Mitigation strategies must be identified and implemented at each actionable process step to provide assurances that vulnerabilities are minimized or prevented. These mitigation strategies must be tailored to each facility and its procedures.

  • The final rule recognizes that a mitigation strategy, applied in a directed and appropriate way to protect the actionable process step from an insider attack, would sufficiently minimize the risk of intentional adulteration. [21CFR121.135(b)]

Role of Management in Mitigation Strategy

Management must take necessary steps to ensure proper implementation of each mitigation strategy. In each of these areas of food defense, the facilities are given more flexibility to establish the actions most appropriate to their operation and product.

  • Monitoring: Establish and implement procedures, including the frequency of monitoring the mitigation strategies. 21 CFR 121.140
  • Corrective actions:  Responses if mitigation strategies are not properly implemented. 21 CFR 121.145]
  • Verification: Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made. [21CFR121.150]
  • Training and recordkeeping: Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training. Facilities must maintain records for food defense monitoring, corrective actions, and verification activities. [21CFR121.1]         

Compliance Dates

FDA recognizes that many of the food facilities covered by this rule will be implementing and meeting the requirements of other FSMA rules. Therefore, FDA is providing a longer timeline for facilities to comply with the intentional adulteration rule.

  • Very Small Businesses – defined as businesses (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g. held for a fee). These businesses would have to comply with modified requirements within five years after the publication of the final rule. (July 26, 2021)
  • Small Businesses – a business employing fewer than 500 persons would have to comply four years after the publication of the final rule. (July 26, 2020)
  • Other Businesses – a business that is not ‘small’ or ‘very small’ and does not qualify for exemption would have to comply three years after the publication of the final rule. (July 26, 2019)

Exemptions to The Rule Are:

  • ‘Very small’ businesses are exempt. However, these businesses must provide  documentation to FDA to prove the business is ‘very small’.
  • The holding of food, except the holding of food in liquid storage tanks
  • The 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
  • On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule. These foods include certain types of eggs, and certain types of game meats.

FDA assistance to industry

  • The agency will publish guidance documents to provide information that is relevant to the provisions of the final rule.
  • FDA has a number of existing tools and resources available on their website (www.fda.gov/fooddefense) developed for voluntary food defense program.
  • The Mitigation Strategies Database is an online, searchable listing of mitigation strategies that can be applied to different steps in a food operation to reduce the risk of intentional adulteration. 

Dr. Nayini earned his Ph.D in Food Sciences and Nutrition at Michigan State University and accrued 30 years of food industry experience working with Columbus Foods, Praxair Inc, Griffith Foods, Tyson Foods and Pepsico. He now provides Food Safety and Processing consulting services to the food and related industries.

Anresco Laboratories is family owned and provides comprehensive analytical testing services to food and cannabis industries

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