The Food Safety Modernization Act (FSMA)
The implementation of new FSMA rules will require comprehensive changes to your company’s food safety compliance program. The following checklists can help guide the development and implementation of a food safety plan to help satisfy the new FSMA requirements for Rule 1, Preventive Controls.
Scope and Personnel
☐ Designate an FSMA Qualified Individual, competent FSMA Auditor and competent Sanitation Manager.
☐ Establish roles for Qualified Individuals, delegating responsibility for every step of your safety plan’s implementation,
verification, validation and correction.
☐ Ensure that Qualified Individuals have been trained in the application of risk-based preventive controls.
☐ Determine which FSMA requirements are applicable to your facility.
☐ If any sections of FSMA do not apply to your facility, the reasons for non-applicability must be justified in your Food Safety Plan.
Identify and evaluate known or reasonably foreseeable hazards. Section 103 (21 U.S.C. 350g (b))
☐ Hazards should be evaluated based on the significance of the risk they pose. A significant hazard is either highly probable,
could have severe consequences, or both.
☐ Is the hazard likely to occur if preventive measures are not taken? For example, the spoilage of fresh produce is almost
certain if preventive controls are not in place to remove blemished and bruised fruit from the production line.
☐ Does the hazard pose a severe threat to consumers? For example, cross-contamination with peanut residue could
endanger the lives of allergic consumers. No matter how unlikely, the severe consequences of contamination warrant
☐ Allergens should be evaluated with a focus on points at which cross-contamination hazards could emerge.
☐ Labeling: Are raw ingredients containing allergens properly labeled?
☐ Storage: Are storage areas organized to minimize the chances of allergen contamination from a spill? Can storage
areas be effectively cleaned in the event of an allergen spill? Are bulk storage containers and silos designated
☐ Staging: Do ingredients containing allergens share staging areas with allergen-free areas? Are staging areas
designed for thorough cleaning between production runs?
☐ Utensils: Are separate utensils used for preparing allergen-free foods? Are they clearly marked? Do utensils share
storage or cleaning areas?
☐ Personnel: Are any workers able to move between areas preparing allergen and allergen-free products? What PPE
and sanitation procedures are needed to prevent cross-contamination?
☐ Equipment: Is processing equipment designed for sanitation? Are processing surfaces free of cracks that could
☐ Transportation: Are transportation containers routinely sterilized? Are ingredients transported at proper
temperatures? Are containers designed to effectively seal out environmental contaminants?
☐ Sanitation: What measures are in place to prevent cross-contamination from employees? Are processing areas
designed for routine sanitation?
☐ Raw materials: Are raw ingredients checked for spoilage and contamination prior to processing?
☐ Grounds: Are pests, dirt, and other potential contaminants present on the facility’s grounds?
☐ Structure: Are roofs and walls effectively sealing out environmental contaminants?
☐ Non-contact surfaces: Are the facility’s floors and fixtures free of cracks that could harbor bacteria or other
☐ Plumbing and HVAC: Are drains and vents able to be sanitized?
☐ Non-food chemicals: Are potentially hazardous chemicals properly labeled and stored? Do routine maintenance
tasks require introducing non-food chemicals into the processing area?
☐ Are suppliers of potentially-hazardous ingredients routinely audited?
☐ Have the preventive controls of suppliers been documented and reviewed?
☐ Does your Food Safety Plan require taking action if a supplier fails to conform to your standards?
☐ Intentional adulteration: Could a malicious employee or intruder intentionally contaminate products? What supervisory
measures are in place to prevent and detect intentional contamination?
Action must be taken to minimize or eliminate significant hazards.
☐ Monitoring. Your Food Safety Plan should:
☐ Identify Critical Control Points where contamination can be stopped at its source (ie, handwashing stations,
pasteurization baths). What oversight procedures are in place to ensure the Safety Plan is followed at these points?
☐ Specify critical limits (eg, temperature, or cooking time) which must not be exceeded.
☐ Schedule routine product testing to verify the effectiveness of controls.
☐ Constantly monitor the processing environment (eg, condensation from pipes, accumulation of waste materials) to ensure conditions do not promote contamination.
☐ How can you confirm that preventive controls are effectively mitigating hazards?
☐ What key performance indicators will demonstrate that hazards have been reduced or eliminated?
☐ Do verification processes follow a regular schedule?
☐ Is verification performed by a designated Qualified Individual?
☐ Are implementation records regularly audited for compliance?
☐ Is testing equipment routinely calibrated to ensure accuracy
Corrections. If a critical limit is exceeded:
☐ How will the contaminated product be removed from production and disposed of?
☐ Who will be responsible for revising procedures to prevent recurrence?
☐ How will the implementation of new controls be verified?
☐ What new testing protocols will be used to validate the effectiveness of new controls
☐ Has your Food Safety Plan been reanalyzed in the past three years?
☐ What is the process for revising the plan to mitigate new hazards?
☐ How will the plan adapt to the introduction of new production processes?
☐ Does the plan reflect the latest food safety research?
☐ Is there a documented plan in the event of a recall?
☐ Has a recall team been designated? Are the team members’ roles clear?
☐ Can at least 98% of the affected product be removed from the supply chain?
☐ Can all affected products be identified and located within four hours?
☐ Can the supply chain be traced to locate the source of contamination?
☐ What notification procedures are in place to alert distributors in the event of a recall?
☐ What disposal procedures will be followed to ensure the removal of contaminated products and ingredients?
Updated cGMPs: 21 CFR Part 117
Updated cGMPs in Part 117 will supplant the current requirements in section 110. The following is a partial list of the most significant cGMP updates.
• Wearing outer garments suitable for protection against allergen contamination of food, food‐contact surfaces or food packaging. 117.10
• If the plant grounds are bordered by grounds not under the operator’s control, care must be exercised by inspection to exclude pests, dirt and filth that may be a source of food contamination. 117.20
• Taking adequate precautions to reduce the potential for allergen cross‐contact and for contamination of food. 117.20
• Taking adequate precautions to protect food in installed, outdoor bulk vessels by any effective means including protective coverings, controlling areas over and around the vessels and checking (on a regular basis) for pests/infestation. 117.20
• Cleaning and sanitizing utensils and equipment must be conducted in a manner that protects against allergen cross‐contact and against
contamination of food, food‐contact surfaces or food‐packaging materials. 117.30
• Pests must not be allowed in any area of a food plant. Guard, guide or pest‐detecting dogs may be allowed in some areas of a plant if the
presence of the dogs is unlikely to result in contamination of food/contact surfaces. 117.35
• Sanitation of food‐contact surfaces, including utensils. These surfaces must be cleaned as frequently as necessary to protect against allergen contamination of food. 117.35
• In wet processing, cleaning is necessary to protect against allergen cross‐contact or the introduction of microorganisms; all food‐contact surfaces must be cleaned and sanitized before use and after interruption. 117.35
• Sanitation of non‐food‐contact surfaces of equipment used in the food plant. These surfaces must be cleaned in a thorough manner and as frequently as necessary to protect against allergen cross‐contact. 117.35
• Cleaned and sanitized portable equipment with food‐contact surfaces and utensils must be stored in a manner that protects them from allergen contamination. 117.35
• All plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed and of such material as to be cleanable, and must be maintained to protect against allergen contamination. 117.40
• Food‐contact surfaces must be maintained to protect food from allergen and being contaminated by any source, including unlawful indirect additives. 117.40
• Seams on food‐contact surfaces must be smooth or maintained to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and allergens. 117.40
• Adequate precautions must be taken to ensure that production procedures do not contribute to allergen contamination. 117.80
• Raw materials and ingredients must be inspected and segregated or handled to ascertain that they are clean for processing into food and stored under conditions that will protect against allergen contamination. 117.80
• Raw materials and ingredients that are food allergens, and rework containing food allergens, must be identified to prevent allergen
• All food manufacturing, processing, packing, and holding must be conducted under controls as are necessary to minimize the growth of
microorganisms and allergen contamination of food. 117.80
• Effective measures must be taken to protect finished food from allergen contamination by raw materials, other ingredients or refuse. 117.80
Bill Bremer is a Principal with Kestrel Management’s Chicago area practice and heads Kestrel’s food safety consulting group. In his food compliance roles, he has led compliance and assurance activities to help many food industry companies meet FDA/FSMA, GFSI (i.e., BRC, IFS, FSSC22000, SQF), HACCP, EHS, and overall operations management requirements.