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The U.S. House of Representatives (HOR) allocated $2.72 billion dollars in discretionary funding to the U.S. Food and Drug Administration (FDA) as part of the fiscal year 2016 spending bill.  HOR released the bill on December 15.

The bill designates an increase of $104.5 million dollars to FDA’s food safety activities.  This is likely due to the ongoing implementation of FDA’s Food Safety Modernization Act (FSMA), an act that aims to change the United States’ approach to food safety to preventive rather than reactive.  With an overhaul of the food safety system come new regulations, and those regulations need funding.

FSMA puts more responsibility on the food industry to ensure that America’s food supply is safe.  The act requires FDA-registered food facilities and importers of food and beverages to identify and control potential hazards of foods they supply as well as monitor the FDA compliance of their suppliers and the food they receive from them.

FSMA also created an inspection frequency mandate for the first time.   FSMA requires FDA to inspect all high risk U.S. facilities by 2016 and again every three years thereafter.  FDA must inspect all non-high-risk U.S. facilities by 2018 and again every five years thereafter.   For foreign facilities, FDA must double the number of inspections it conducts every year through 2016.  The increased funding may help FDA meet the FSMA inspection mandate.

FDA has published five of the seven major FSMA rules thus far. The agency published its Preventive Controls rules in September.  In November, FDA published the produce safety, the foreign supplier verification program (FSVP), and the third-party accreditation rules. The final sanitary transport rule is due March 2016 and the final rule on intentional adulteration is due May 2016.

Registrar Corp is an FDA consulting firm and stays up to date on FSMA developments. Our Regulatory Specialists can help you prepare for an FDA inspection, create a food safety plan as required by the Preventive Controls rules, and more.  If you have any questions about new FDA requirements under FSMA, or if you would like compliance assistance, contact +1-757-224-0177 or live help is available 24-hours a day at

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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