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Preparing for FSMA Compliance: Are You Ready?
by Jim Bail
By now, your organization has begun preparation to comply with the Food Safety Modernization Act or FSMA. This article provides background on FSMA and highlights some best practices that will help your organization with compliance.
President Obama signed FSMA into law in 2011 and the FDA began publishing proposed rules in January 2013.
The Act makes extensive changes to U.S. food safety laws, most notably shifting focus from reacting to food safety problems to preventing them in the first place. By requiring a risk-based approach to identifying and implementing preventive controls, FSMA places new and more extensive requirements on food manufacturers, processors, growers, and importers. The Act focuses primarily on the following to minimize or prevent food safety hazards:
- Produce safety,
- Imported food safety,
- Mandated inspections on a risk-based schedule,
- Third-party laboratory testing,
- Farm-to-table responsibility, and
- Ability to require third-party certification for high-risk operations.
Another important component of the legislation provides for FDA recognition of accredited third-party audit and certification programs for imported foods a category that has grown steadily over the years.
Currently, the FDA is holding meetings and receiving comments on how to best implement the new law and promulgate effective regulations. Additional updates can be found at www.fda.gov/fsma.
The FDA is required to publish several rules that will be the basis for compliance enforcement once they are made final. These rules are to be presented in draft form to the public for a specified comment period. To date, two of the five proposed FSMA rules related to produce and processing have been published. The public comment period for the two proposed rules has already been extended, but a word of advice: Don’t wait.
Start preparing for FSMA now by reassessing your prerequisite programs and Hazard Analysis and Critical Control Points (HACCP) plans. Are SOPs or standard operating procedures current and adequate for their purpose? Has employee training been conducted and documented? The following are some key steps to keep in mind.
- Develop your Food Safety Plan.
- Identify, train, and qualify the experienced individual who is responsible for developing the facility’s Food Safety Plan.
- Identify and evaluate the hazards that could affect food manufactured, processed, packed, or held by your facility.
- Identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that the food you make is not adulterated.
- Monitor the performance of those established controls.
- Maintain records of monitoring as a matter of routine practice.
- If you are importing foods, you are responsible for compliance to FSMA by your foreign suppliers.
Once the basic food safety elements are developed and implemented for your operations, you may not have as much to modify once the final rules are published.
Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility and food.
Where to start? It can be summed up in two words: Plan ahead. Companies can begin by performing a basic hazard analysis.
Prepare a written Food Safety plan that documents and describes the procedures used by your facility to comply with the requirements of the Act, including analyzing the hazards and identifying the preventive controls adopted to address those hazards. Your written plan, together with the documentation must be made promptly available to a duly authorized representative of the FDA upon oral or written request.
Identify, train, and qualify your skilled individual who is responsible for developing your facility’s Food Safety Plan. Establish your team with clearly defined roles and responsibilities.
Perform a hazard analysis. Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility and food including:
- Biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives;
- Hazards that occur naturally, or may be unintentionally introduced;
- Hazards that may be intentionally introduced, including by acts of terrorism; and
- Develop a written analysis of the established hazards.
Identify and implement preventive controls, including any critical control points, to provide assurance that:
- Validate your HACCP plan, control points, and limits using objective, scientific, and defensible data;
- The hazards identified in the hazard analysis will be prevented, eliminated, or significantly minimized; and
- The food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Food Drug and Cosmetic Act.
Monitor the effectiveness of the preventive controls you have implemented.
Establish corrective action procedures to ensure that if the preventive are not properly implemented or are found to be ineffective:
- Appropriate action is taken to reduce the likelihood of recurrence of the failure;
- All affected food is evaluated for safety; and
- All affected food is prevented from entering into commerce if the owner, operator, or agent in charge of your facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w) of the Food Drug and Cosmetic Act.
- The preventive controls implemented are adequate to control the hazards identified;
- You are making appropriate decisions about corrective actions;
- The preventive controls implemented are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and
- There is documented, periodic reanalysis of the plan to ensure the plan is still relevant to the raw materials, conditions, and processes in the facility, and new and emerging threats.
Maintain records for not less than two years, documenting:
- The monitoring of the preventive controls implemented;
- Instances of nonconformance material to food safety;
- The results of testing and other appropriate means of verification instances when corrective actions were implemented; and
- The effectiveness of preventive controls and corrective actions.
Conduct a reanalysis of your preventive controls whenever a significant change is made in the activities conducted at your facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or not less frequently than once every three years, whichever is earlier. This reanalysis must be completed and additional preventive controls needed to address the hazard identified, if any, must be implemented before the change in activities at the facility is operative. You must revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed.
Completing these steps will help companies prepare for FSMA and be ready once the final rules are passed.
Bail is the director of supply chain food safety technical services for NSF International. He can be reached at email@example.com or 734-827-6844.