Deadline looms for Food Safety Modernization Act compliance

The Food Safety Modernization Act (FSMA) was passed by Congress in January of 2011 in response to an increase in the number of foodborne illnesses that made headlines during the 2000s. Considered the first major piece of Federal legislation addressing food safety since 1938, the FSMA gave the Food and Drug Administration (FDA) new abilities to regulate the way food is grown, harvested and processed. In addition, the FSMA granted the FDA the authority to issue mandatory recalls.

The FSMA raised the requirements for many manufacturers and transportation companies within the food and beverage industry to take active steps to prevent food safety issues rather than merely reacting to them once they have occurred. Notably, this legislation also covered breweries and wineries. In many cases, the mandated compliance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP) directs the food and beverage industry to enact many of the same practices already employed in the pharmaceutical industry.

The ultimate goal, of course, is to ensure public confidence in the nation’s food supply while preventing outbreaks of any of the 31 known pathogens and ‘unspecified agents’ transmitted through food, including E. Coli, Salmonella and Listeria.

Previously, the FDA had only been able to issue guidance documentation, lacking the ability to enforce the standards. The very high-profile outbreaks which have happened show not only that contamination can occur anywhere where standards have not been met, but that the financial impact of such an incident far outweighs the cost of compliance.

Compliance required for businesses of all sizes

For its part, the FSMA directed that the FDA had to establish science-based preventative controls and minimum standards that cover every aspect of the U.S. food system, ranging from farmers and manufacturers to importers and transporters. The standards had to take into account natural hazards as well as accidental and deliberate contamination.

Since it was enacted, the FSMA has been implemented in a phased manner with the biggest companies having to create and document their procedures. Smaller companies and entities were given progressively longer periods to come into compliance with “very small businesses” (defined as less than $1 million in total sales of human food) having until January 2020 to comply with the documentation and implementation rules known as Hazard Analysis and Risk-Based Preventative Controls (HARPC).

The biggest impact for businesses in the industry is the requirements mandated under HARPC. The ‘hazard analysis’ portion of the regulations involves the company reviewing its facilities, equipment and processes to identify potential food safety problem areas along with evaluating the risks associated with those identified problems.

Once the hazards have been identified, the ‘risk-based preventative controls’ portion comes into play. Plans must be developed for minimising risks and controls must be in place to ensure that the risks are continuously monitored and controlled. Consistent execution and constant evaluation are key as is creation of corrective plans of action for potential problems that may occur during operation. Equally critical is the thorough documentation of the compliance procedures with the ability to produce them for inspection during audits.

Proactiveness is the key

Many foods are processed with stainless steel equipment or stored in stainless steel tanks. The common impression is that stainless steel is not subject to corrosion or contamination, but between mechanical forces, acidity or abrasiveness of the materials and other factors, the thin, corrosion resistant layer of stainless steel can get damaged and require restoration.  This can be addressed with surface treatments such as mechanical and electropolishing along with passivation, augmented with a regimen of regularly scheduled, high-purity chemical cleanings, sterilisations and sanitisations.

Many companies find the prospect of implementing a HARPC plan to be a daunting prospect. While the company’s staff may have the needed institutional knowledge required to detect and prevent problems, they cannot be expected to know all of the key points required to produce compliant documentation. In such cases, an outside company with the needed expertise can be contracted to help plan, implement and, just as importantly, document the HARPC process to ensure FSMA compliance.

It is important to engage a partner that has deep experience with the food and beverage industry as they will have the required knowledge needed to avoid the pitfalls that may lie ahead.