Coincidence or not, following closely on the heels of major food poisoning incidents in the United States, the FDA kicks FSMA into high gear. The Centers for Disease Control (CDC) cautions that there are about 24 multi-state (involving at least two states) food contamination outbreaks each year. That averages two major outbreaks each month.
The most recent outbreak involved E. coli from fresh produce which led Chipotle to voluntarily close 43 restaurants in Portland and Washington this past week-end (October/November 2015). And this outbreak follows incidents of salmonella poisoning from tomatoes served at the restaurants in Minnesota in August/September, 2015.
In the last twenty (20) years, major foodborne outbreaks in the U.S. have more than tripled, writes The Washington Post. While there have been 4,000 reported incidents in all, those that have involved more than one state are bigger and more lethal. They have caused more than half of all deaths, the article continues. The foods implicated were wide-ranging – fresh fruits and vegetables, chicken, beef, and even caramel apples. Most commonly, the germ-culprits have been E. coli, listeria, and salmonella.
Imported foods have accounted for only 18% of the large outbreaks. This is why, as the FDA kicks FSMA into high gear, the agency’s focus is on foreign and domestic suppliers.
What is FSMA?
The Food Safety Modernization Act (FSMA) aims to address the problem of these food contaminations by transforming the U.S. food safety system. The goal is to change the focus from reaction to prevention. Signed into law in January, 2011, FSMA is being implemented in stages. Already in place are rules that require food facilities to be registered with the US Food & Drug Administration (FDA), required information for advance notice of imported foods, permit the FDA to detain food imports, and impose recordkeeping requirements. (More information on the FSMA process is available here.)
In September, final rules were introduced for:
- Rule for Preventive Controls for Human Food and Rule for Preventive Controls for Food for Animals, which require that affected businesses establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. For some businesses, the deadline to comply begins as soon as September 2016.
On November 2nd, the FDA announced that the following final rules are ready and will shortly be published:
- Rule for Produce Safety establishes standards for growing, harvesting, packing, and holding produce for human consumption (rule as proposed by FDA is available here)
- Revised Rule for Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (background information is available here)
- Rule on User Fee Program to Provide Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certification (rule as proposed by FDA is available here)
Typically, businesses will have 18 months from the date the rules are published to implement the new rules.
The FDA has announced a strategy to train industry as it rolls out these new rules. Stay tuned, also, for our blog posts as we explain the rules and what they will mean for you!