The Food Safety Modernization Act (FSMA) - U.S.

BACKGROUND: (Quote from FDA website) “The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011.  It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”  There were few changes at first due to the time needed to research and write the specific regulations that would implement this objective.

In January of 2013 the FDA published for comment the draft regulations that would “put the teeth” in the FSMA.  Modifications led to a second comment period that closed in December, 2015.  After many delays, the regulation was finally published in the Federal Register in September of 2015, with an initial compliance date for large processors of September, 2016.  Just before this date, however, FDA extended compliance dates for an additional 2 years, meaning that large companies now have until Sept. of 2018.

Since Manoush Associates specializes in food manufacturing, only that part of the regulations will be discussed here, but it is worth noting that there are several other sections of the regulation, including produce safety and on-farm controls, foreign supplier verification and animal food production.  Companies involved in business other than domestic human food should review the regulations that affect them.

IMPLICATIONS FOR MANUFACTURERS: The bottom line for those companies engaged in food manufacturing is that a written food safety plan (FDA now uses the broader term, “food safety” instead of HACCP) will become mandatory by the following compliance dates.  Larger companies with over 500 employees will have until Sept, 2018 to comply.  Smaller companies will be given one additional year to comply, while very small companies (<$1 million in sales) will be granted 2 additional years and a much less stringent set of requirements.

Those companies already covered by regulatory HACCP as shown on the HACCP REGULATIONS page of this site, will experience little change since those specific regulations will remain in effect.  For the many other companies engaged in food manufacturing there will be a great deal of work to do, and this should not be underestimated and left until the last minute.  Even if you already have a HACCP plan, the new regulation contains requirements for Preventive Controls, training, verification and record keeping that will require changes in your plan(s).

HOW TO PROCEED: Affected companies should study the regulation at once.  It is lengthy and will require significant time to digest.  If you are part of a trade association you will likely find good help available there.  The FDA web site will provide substantial guidance as well as examples and links to training resources as it has done with previous new regulations, but again, do not underestimate the time and effort it will require to understand your new responsibilities and to fully comply with this law.

At least one person at your firm should become a PCQI, or Preventive Controls Qualified Individual.  The use of a consultant such as Manoush Associates can be of significant benefit, particularly if your company staff does not include anyone with scientific training regarding food pathogens and their control.  However, an in-house Food Safety coordinator is still a must even with the use of a consultant.  We can help you do a hazard analysis and write the Food Safety plan, but the responsibility to implement the plan (monitor the control points, keep accurate records, respond to deviations and more) remains a legal responsibility of the processor that cannot be delegated to an outside service.  If you do not comply with this regulation by the final dates published, your products may be considered in violation and subject to recall, even if there is no known problem with them!  To discuss your specific situation please contact us.

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