The Food Safety Modernization Act (FSMA) was signed into law a little over a year ago — on January 4, 2011. According to the U.S. Food and Drug Administration, it is the “most sweeping reform of our food safety laws in more than 70 years, and aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.” Registration under this new law is not only required of manufacturers of human food products — but also pet food and animal feed manufacturers — thus our focus on this legislation and its management implication in this month’s column.
We understand that additional regulations are not popular and you may be tempted to stop reading right now. We urge you to resist that temptation, keep reading to learn more about the regulations so you can develop a proactive approach. In the following section we present an overview of the changing regulatory environment, to provide some perspective. Then we highlight the current changes affecting the feed and grain industry. In the final section we suggest some approaches you as the manager could adopt to ensure that your business is both compliant and can enjoy business success and profitability.
Changing regulatory environment
Many observers might argue that the Food and Drug Administration (FDA) has transformed from a regulatory agency to a public health agency. Recent actions by FDA highlight this change in thinking — a case in point was the nation’s second-largest processor of pistachios agreeing to recall its entire 2008 crop despite no confirmed illnesses. This was primarily an issue with sanitation practices and Salmonella found in the processing environment — there were food safety concerns, but this was a “proactive/preemptive response,” and there were no documented illnesses attributed to this pathogen (California-based Setton Farms was the firm involved, and according to press releases at the time “…health officials stressed that this is how the food safety net should work: By recalling products to prevent an illness outbreak, rather than reacting after an illness has spread.”) This is a very different mindset than has been in place in the past, and is part of the discussion that led to passage of the FSMA. The legislation was supported by many of the major food trade organizations based on the following issues:
1) A significant feeling that “all ships rise and fall together on the tide of public opinion,” in other words — a problem in one area of the food industry negatively impacts many of the other areas,
2) Imports should be equally as safe as domestic foods; and
3) No company should be allowed a competitive advantage by taking food safety shortcuts.
The FSMA represents the most significant expansion of food safety requirements and FDA food safety authority since the original enactment of the Food, Drug and Cosmetic Act (FDCA) of 1938 which broadened the powers of the FDA (so named in congressional action in 1930). It grants the FDA a number of new powers, including mandatory recall authority. Specifically, it covers the following highlighted areas (this is a non-exhaustive list): traceability, recordkeeping and expanded records access (sections 101, 204); certification/accreditation of third party auditors (section 307); laboratory accreditation (section 202 and others); whistle blower protection (section 402); sanitary transportation of food (section 111); improving the Reportable Food Registry (section 211); and fees (section 107), increased inspection of facilities, administrative detention, food defense, preventive controls, produce safety standards, food safety plans and many other requirements.
Mandatory recall authority
Under FSMA, FDA may force a recall of a product if:
1) There is a reasonable probability that the food is adulterated or misbranded;