Food Safety by Design: Focus on FSMA Preventive Controls

According to Dr. David Acheson, Founder and CEO of the Acheson Group, FSMA passed Congress because of public, congressional and regulatory response to a series of major outbreaks that started with the spinach E. coli O157 in 2006, salmonella cases in peanut butter in 2007 and 2009, melamine in pet food in 2007 and most recently the Peanut Corporation of America that led to multiple deaths resulting in shutting down the company and imprisoning several top executives.

FDA Expectations

FDA expects to see a validated food safety plan that is maintained and monitored continuously, according to Dr. Acheson. This means a company must identify all the risks pertaining to the food you manufacture, process pack or hold. This requires determining which risks need to be controlled to prevent food borne illness; understanding how to control the risks (in plant and supply chain); making sure that those risks are being controlled; and tracking that the systems are working every day.
According to the expert, what keeps a food company executive awake at night is regulatory compliance; economic pressures on the company; innovation and the chance of a recall. To protect the brand, every company must implement risk based preventive controls.

Final Preventive Controls Rule

The key principles of the Preventive Controls Rule

  1. Rules are risk based and focused on prevention
  2. Each facility is required to implement a written food safety plan that focuses on preventing “hazards requiring preventive controls”
  3. Facilities must identify “Hazards Requiring Preventive Controls” and then implement preventive controls
  4. Facilities should monitor, verify, validate, and take corrective actions
  5. Facilities must keep records

FDA can inspect your food safety plan which is protected by the Freedom of Information Act (FOIA) and considered a “Trade Secret” unless there is a problem which means there is no more protection under FOIA.

Does your facility manufacture, process, pack, or hold food? If so, you need to register unless exempt. Exemptions are defined in the rules. The next facility registration is due November, 2018.

The Food Safety Plan

You must prepare, or have prepared, and implement a written food safety plan, says Dr. Acheson. The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. Preventive controls qualified individual means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

Environmental Monitoring

Environmental monitoring would be required where ready-to-eat (RTE) product is exposed to the environment prior to packaging and the packaged food does not receive a treatment that would significantly minimize an environmental pathogen that could contaminate the food when it is exposed. Routine testing does not have to be conducted by an accredited lab, the test method must be scientifically valid, and results do not need to be sent to the FDA. For details on verification and reanalysis procedures refer to FSMA rules as outlined in Dr. Acheson’s presentation.

FSMA Approach to Supply Chain Control

The Preventive Controls Rule (Human and Animal Food) requires that registered firms must assess supply chain risk. If suppliers are responsible for controlling risk, the customer must verify that the risk is being controlled. The Foreign Supplier Verification Program shifts the burden of ensuring safe food to importers who are required to perform risk-based activities to verify that food imported into the U.S. is to the same food safety standards as those required of U.S. producers.

The receiving facility must establish and implement a risk-based supply chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain applied control in a written program. When applied by an entity other than the receiving facility’s supplier, the facility must verify the supply-chain-applied control; or label food as not having the risk controlled; and obtain documentation of an appropriate verification activity from another entity, review and assess the entity’s applicable documentation, and document that review and assessment. Refer to the rule for importers responsibilities, exemptions and verification procedures.


To the extent that an existing HACCP plan or GFSI-compliant food safety plan includes all required information, a facility can use such plans to meet the requirements of this rule. Areas of difference are that GFSI is HACCP focused with CCPs and a prerequisite program. FSMA is HARPC focused with risks that require a preventive control and it avoids creating CCPs for all risks. When implemented properly both will protect the food supply.

According to Dr. Acheson, his group “has compared several GFSI schemes with FSMA Preventive Control Rules for SQF, BRC, and FSSC: all match up well and are essentially either comparable or exceeding FSMA … Compliance with FSMA Preventive control rules will reduce brand risk through supply chain risk and environmental control programs,” adds the expert. “Record keeping is critical. Maintain the program; don’t just build it and walk away! Being GFSI compliant is a good start to FSMA compliance,” he concludes.

Download Dr. Acheson’s presentation for a complete outline of the components of a Food Safety Plan that includes hazard analysis, preventive controls, monitoring, corrective action, verification, reanalysis, and documentation.