Strict Food Quality Rules Come into Effect This Week: FSMA Compliance [Posted on: Thursday, September 22, 2016]

The first stage of the implementation of the Food Safety Modernization Act (FSMA) officially came into effect this Monday (19 Sep 2016) whereby all large food manufacturers, with 500 or more employees, have to be in compliance with strict food quality and contamination prevention standards. The food GMP regulations require manufacturers to control all aspects of growth, collection, processing, packaging, and distribution to assure absence of microbial contamination and prevent spread of diseases. The law was enacted in Jan 2011 in response to wide-spread incidences of food poisoning related to contaminated food sold of consumers. For the last 6 years, FDA has been very busy creating rules and infrastructure to implement this law with perhaps the largest impact of every life of all Americans. The law applies to farmers, food manufacturers, distributors, shippers and retailers. FDA wrote about 30 new rules and released 24 new Guidance documents describing requirements for practically all aspects of food industry. It also held 21 public meetings and 5 online seminars to educate the industry about the new requirements. Overall, the focus has been on education and training rather than enforcement. This changes starting this week. The first step of the final implantation of the law starts this week whereby large food manufacturers could be audited and, if found to be non-compliant, penalized. One year from now, the medium size manufacturers will need to be in compliance and after 2 years, all manufacturers, big and small, are required to be in full compliance. In its announcement of the milestone, FDA acknowledged that over the last 6 years, much of the large food manufacturers already have implemented core elements of FSMA, namely the hazard control requirements. Hence the Agency does not expect many issues, however, it warns the manufacturers that they should be ready at all times to be inspected, and that it will not tolerate non-compliance. This should be an interesting year as for the first time contamination of food will be an FDA compliance issue for an industry that has never before been subject to such strict federal rules. Being a Federal rule, FSMA is expected to have a much wider impact than local rules. FDA is planning to work closely with local regulators. The laws governing food supply are vast and require not only extensive training, but also robust managerial oversight and quality systems. While large corporations can afford the resources needed for compliance, it would be interesting to see how the small “mom and pop” food manufacturers comply. For a small manufacturer with limited resources and small revenues, getting proper training and maintaining the required documentation may be highly burdensome. But the law is here to stay, so the smaller manufacturer will either comply or close shop. The good news is that FDA plans to create many free educational programs and apply enforcement discretion, much like it has done for the other industries like the dietary supplement and cosmetic industries. Increased regulation is much needed and these steps should help indeed.