FDA will have a legislative mandate to require comprehensive preventive controls across the food supply

The FSMA Final rule will protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal harmful means

The U.S. Food and Drug Administration (FDA) is due to release the Food Safety Modernisation Act (FSMA) Final Rule on Intentional Adulteration on May 31, 2016. Food Industry Security Professionals will soon be tasked with assessing their facilities to reduce supply chain food adulteration vulnerabilities.

Food Security Professionals will need to develop an effective site plan to include where and when to conduct vulnerability assessments, implement focused mitigation strategies, and examine resources available to the food defence practitioner to minimise risk exposure and meet outlined regulatory requirements.

Food Drug Administration’s proposed rule on food defence

The FDA’s proposed rule on food defence would require facilities to address vulnerable processes in their food supply operations to prevent acts of intentional adulteration intended to cause large-scale public harm. Some background on what led to this aspect of the rule may provide insight into its key elements. The Act was signed into law on January 4, 2011 to better protect human and animal health by helping to guarantee the safety and security of the food and feed supply. Its focus was to ensure that the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing contamination. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention & risk-based food safety standards, and to better respond to and contain problems when they do occur.

 Danger of large-scale public health harm

Intentional adulteration includes those types of acts committed by disgruntled employees, consumers, or competitors where the intention is to cause large-scale public health harm; or by economically-motivated adulteration. Acts of disgruntled employees, consumers, or competitors are generally directed at attacking the reputation of the company and not at causing public health harm. The primary purpose of economically-motivated adulteration is to obtain economic gain, and not to impact public health, although public health harm may occur. From a historical perspective, the threat to the food supply chain has been evident for decades.

Examples include during World War I when German agents in the U.S. infected horses and cattle in transit across the Atlantic to France; to al Qaeda documents and manuals found in Afghanistan after the 2001 U.S.-led invasion revealed interest in conducting chemical & biological attacks on food supplies; to 2014 when a Chinese court sentenced a former plant employee to life in prison after the poisoning of frozen dumplings that made at least 10 individuals ill.

An effective overall site security plan will soon require the aspect of food defence to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means. The rule applies to facilities required to register as “food facilities” under Section 415 of the Food, Drug, and Cosmetics Act. Facilities covered under the rule would be required to develop a “Food Defence Plan” and identify and implement mitigation strategies to minimise or prevent significant vulnerabilities in food operations. The four key activities within the food system that are the most vulnerable to intentional adulteration, and have the potential to cause large scale public harm, are defined as liquid receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing and similar activities.


Personnel and supervisors assigned to the Actionable Process Steps would be required to receive appropriate training in food defence awareness and in their responsibilities for implementing Focused Mitigation Strategies

Each facility will be required to conduct a reanalysis of its Food Defence Plan at least once every three years

Food Defence Plan against intentional contamination

Covered facilities would be required to review their production systems to determine if they have any of these activity types and conduct their own vulnerability assessment to identify and prioritise points in their food operations that may be vulnerable to intentional adulteration. For the first time, FDA will have a legislative mandate to require comprehensive preventive controls across the food supply. This mandate includes compulsory preventive controls for food facilities to include the implementation of a written preventive controls plan. This plan involves:

  1. Evaluating the hazards that could affect food safety
  2. Specifying what preventive steps, or controls, will be put in place to significantly minimise or prevent the hazards
  3. Specifying how the facility will monitor these controls to ensure they are working
  4.  Maintaining routine records of the monitoring
  5. Specifying what actions the facility will take to correct problems that arise.

Each facility would be required to conduct a reanalysis of its Food Defence Plan at least once every three years, or following certain conditions (e.g., significant change in facility operations, new information about potential vulnerability, etc.). Personnel and supervisors assigned to the Actionable Process Steps would be required to receive appropriate training in food defence awareness and in their responsibilities for implementing Focused Mitigation Strategies. Facilities would be required to maintain certain records, including the written Food Defence Plan, personnel training documentation, and records related to monitoring, verification, and corrective actions.

Lastly, as the issuing of the Final Rule approaches, the FDA has proposed to also publish a guidance document that provides the requirements in plain language to help businesses, particularly small businesses, comply with the identification of actionable process steps and implementation of focused mitigation strategy requirements. Industry can prepare now by conducting a comprehensive security assessment of their facilities to include the site perimeter, access control, security & emergency procedures, shipping, receiving & warehouse storage security practices, on-site security personnel, law enforcement outreach, site utilities, suppliers, hazardous materials/chemicals, criminal background check programs, cyber security, employee security awareness training, incident reporting & documentation, and recordkeeping requirements. The FDA website also includes useful information on FSMA, as well as links to their software programs such as the “Food Defence Plan Builder” that is designed to assist in developing a food defence plan based on a user entering specific answers relevant to their facility.

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