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FDA proposes new FSMA proactive food safety rules

Attention those in the food industry, new rules released by the FDA that may have an impact on your business. The Food Safety Modernization Act (FSMA) is intended to reduce the rate of food-borne illness in the United States through pre-active measures instead of reactionary action. This means the focus of federal regulators will change from reacting to issues after they occur to prevent them from happening in the first place. New rules proposed under this act that will greatly affect both small and large businesses alike, and thus creating buzz throughout foodie circles. So what do you need to know about FSMA? 

What is the Food Safety Modernization Act?

The Food Safety Modernization Act was signed into law by President Obama in January 2011. This act grants regulators more power in hopes to minimize the number of food borne illness cases in the country. According to the Food and Drug Administration (FDA), regulators will change the focus from responding to food-safety issues to working to prevent them through an increased rate of compliance with prevention and risk based food safety standards in the country.  This will allow for regulators to better respond and contain problems when and if they do happen.

Recently, new laws are being implemented in relation to all imported food as well. The Supplier Verification Program part FSMA will be executed in partnership with state and local authorities, ensuring imported foods are held to the same standards as foods produced here in the U.S. Currently, food imports account for 15% of the U.S. food supply and even more in areas such as fresh produce.

What new power does this give the FDA?

According to the FDA’s website, this act is groundbreaking and grants the FDA powers it has never had before. The FDA will now have the power to issue mandatory recalls. Before this, it was voluntary for food manufacturers and distributors to recall.

Given that this act is based on prevention, the FDA has required mandatory preventative controls for food facilities, mandatory produce safety standards, and now has the authority to prevent intentional contamination.

Also according to the FDA’s website, FSMA allows for the FDA to gain increased frequency of inspection as well as access to records and requires regulators to establish a program for superior laboratory testing of food.

Mike Taylor, FDA’s Commissioner for food says this shift from reactive to proactive is long overdue: “The current system of oversight is a number of decades old. It relies primarily on being physically able to examine less than 2% of food imports… it relies on detective and reacting to problems.

What does this mean for businesses? Small businesses?

As of January 4, 2013, an FSMA Proposed Rule for Preventive Controls for Human Food was made public and will pose a great effect to businesses if implemented.

This rule will have two parts. First, businesses will now be required to implement a written food safety plan that will focus on the prevention of food borne illness. The second aspect of the rule would update Good Manufacturing Practices.

FDA language states, “These firms would be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results and specify what actions will be taken to correct problems that arise. FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly.” It is proposed this must be implemented within one year of the final rule being published.

Recognizing how this will be more difficult for smaller businesses, they will be granted two years and very small businesses will have three to complete the plan.

How you can be heard

All proposed rules are open for comment from the public. The Preventative Controls for Human Food rule is open for comment until September 16, 2013.

To comment on this or any other proposal, visit the FDA’s website: “http://www.fda.gov/fsma” . The comment period lasts 120 days after the proposed rule was published. 

 

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