In October of 2018, the FDA released new draft guidance for the Food Safety Modernization Act (FSMA) on how to meet its seven key rules for ensuring the safety of our food supply. A month later, the nation was hit with yet another major food-borne outbreak – E. coli-contaminated romaine lettuce that killed five and sickened hundreds of consumers across 36 states.
This disconnect tells us that while progress in modernizing food safety is forthcoming, implementation is happening at a snail’s pace. Yet, the progress is promising, and recent updates to the FSMA may accelerate the transition from simply responding to foodborne illnesses via a food recall, to actually preventing them in the first place.
As deadlines for the FSMA compliance approach, the FDA is tying up remaining requirements and guidelines while the agency begins its enforcement phase. Let’s look at some of the more important new updates for food producers.
Nearly every food recall has been voluntary. But sometimes mandatory recalls are required. In November, the FDA released new guidance on mandatory food recalls; specifically, on how to implement mandatory food recall provisions of the Federal Food, Drug, and Cosmetic Act. It’s the law that gives the FDA the authority to order a company to recall a food product when there is a reasonable probability it is adulterated, misbranded, or can cause serious adverse health consequences or death to humans or animals. The new update explains what the criteria is for a mandatory recall, what processes to follow, and who is responsible for what actions.
Growing, harvesting and handling practices
The aforementioned October draft guidance is designed to help farmers and makers of produce meet FSMA requirements by putting contamination-protection measures in place during growing, harvesting, packing and holding of their fruits and vegetables. For example, the FDA found that in the recent romaine lettuce outbreak, E. coli contamination probably stemmed from tainted water via an irrigation canal located too close to a large concentrated animal feeding operation.
At the same time, the FDA also issued draft guidance – the Guide to Minimize Food Safety Hazards of Fresh-cut Produce – to help fresh-cut produce processors comply with the requirements found in the FSMA rule on Preventive Controls for Human Food Rule. This rule requires food processors to have a food safety plan that can analyze hazards before they get into the food supply, as well as provide preventative measures.
In December, the FDA updated its Intentional Adulteration Rule to provide new and free ways to comply with required FSMA training. The Adulteration Rule aims at preventing intentional adulteration of food in an effort to harm public health, including acts of terrorism targeting the food supply.
The update requires developing risk mitigation strategies for food processing in facilities to prevent intentional harm. The update also includes a number of resources and links to train employees on implementing the mitigation strategies.
Accredited Third-Party Certification
Just before the holidays, the FDA published a user guide for its Accredited Third-Party Certification Program. The voluntary FSMA program enables certain third-party organizations to become “accredited bodies” so they can help the overstretched FDA conduct food safety audits and issue certifications for food facilities.
The program has two objectives: a) address potential safety issues before the food reaches the country, and, b) ensure that imported foods are produced in accordance with U.S. safety standards. This update aims to accelerate the speed and scale of food auditing in the country by throwing more certified resources at the problem.
The volume and regularity of food-borne outbreaks might suggest to some that implementation of the landmark FSMA has been lagging. But we are definitely reaching a turning point as compliance deadlines and enforcement begins to kick in. The good news is that these updates to FMSA rules all reflect the transition to prevention rather than reaction, which is finally becoming a reality.
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