Food Safety Activity Critical Regardless of Final Rule

It was January 4, 2011, when President Barack Obama signed the Food Safety Modernization Act (FSMA) into law. While much has happened around the world to improve food safety regulations, the waiting is ongoing with regard to regulations around several of the foundational provisions which are still pending government review. More specifically, the FDA forwarded its draft regulations to the Office of Management and Budget later in the year of 2011, and, at the time of this writing, that is where the regulations remain.

Granted, a great deal of work and effort has been put forth by many stakeholders, most incredibly by the FDA. FSMA did contain several provisions that went into effect, including the Suspension of Facility Registration, Mandatory Recall, Administrative Detention and Record Access, and the Biennial Registration, to name a few. The Hazard Analysis and Risk Based Preventive Controls (PC) and the Foreign Supplier Verification (FSV) rules are still pending governmental and public review.

In a response letter to the Grocery Manufacturers Association in June, FDA Deputy Director of Foods Mike Taylor reinforced the FDA’s commitment to the full and timely implementation and enforcement of FSMA requirements regarding section 103 Preventative Controls and section 301 Foreign Supplier Verification. While this gave industry an update on the status of sections 103 and 301, the document did not provide specific details of what would be documented within the anticipated regulations. Regardless of any additional specific regulatory content on FSMA, the FDA continues its diligent work and effort toward food safety.

Despite this delay of draft rule review and final rule publication, manufacturers should not take this as a signal to remain idle in anticipation of the new regulations. Those in the industry may even ask if their companies should be doing anything in response to the delayed food safety regulation.

The answer to that question is simple. It is industry’s responsibility to produce, manufacture, package, and distribute safe foods to consumers, and move ahead with what is known in the law toward compliance. Industry also should continue identifying areas of improvement for food safety processes and programs. In fact, the provisions in the law suggest areas for change.

The Preventive Controls rule is a foundational structure toward a successful food safety program. The term HACCP (Hazard Analysis Critical Control Point) is regularly used for prevention and proper food safety controls. But the FSMA expects food manufactures to go beyond HACCP and interpret risk-based preventive controls that go well beyond traditional HACCP methods.

In advance of any final rule, FSMA section 103 provides the following steps that owners, operators or agents in charge of a facility can take to prevent foreseeable hazards:

• Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility.
• Develop a written analysis of the hazards.
• Document implemented preventive control methods to minimize, reduce or prevent the hazard completely.
• Monitor the effectiveness of preventive controls to assure they fulfill their intended purpose.
• Document corrective action to preventive controls if they were not implemented properly or require adjustment. This will reduce or eliminate the likelihood of a recurring failure.

As with any quality process, good record keeping is critical. Documentation tells a story of what has been analyzed and evaluated, identified and implemented. It also confirms that proper controls are in place. Regardless of when the final rule is published, it is prudent for a firm to reanalyze and update documentation to assure it is relevant and up to date. The law requires companies to reanalyze every three years or after any significant change. More frequent updates are encouraged.

As important as FSMA section 103 preventive controls is to food safety, FSMA section 301 is equally important to foreign supplier verification. A good foreign supplier verification program places the expectations of Preventive Controls section 103 within the foreign supplier facility. Even though the regulations are not yet issued, the law is well-known and describes what is expected to be promulgated into regulation. Therefore, manufacturers can begin working with foreign suppliers to confirm their understanding of FSMA, specifically section 103 and 301. It is important to work with the suppliers to advance their risk-based preventive control plans and review documentation of the supplier’s activities around food safety.

There are significant actions you can take to promote food safety and preventive controls that reduce, minimize, or eliminate opportunities that harm the food supply. Focus within and around your facility and complete your due diligence—regardless of the current status of the issuance process. Work with your suppliers around the world to help them understand the forthcoming expectations regarding the FSMA. Those manufacturers that ensure their facility and suppliers are successful with good risk-based preventative control plans will be prepared when the time comes and regulations are put in place.

Bradd Eldridge is Director of Quality Assurance for Abbott Nutrition and is on QA’s Advisory Board.