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Don’t Let FDA’s Delays with some FSMA Regulations Make You Complacent

On January 4, 2011, President Obama passed the Food Safety Modernization Act (FSMA) which became the most significant update of U.S. food safety laws since the passage of the Federal Food, Drug, and Cosmetic Act in 1938.  FSMA mandated a number of changes to food safety laws, including implementation of a Foreign Supplier Verification Program, Voluntary Qualified Importer Program, mandatory preventative controls for all food facilities, and a mandatory registration renewal for all food facilities.  The U.S. Food and Drug Administration (FDA) is responsible for issuing final regulations to implement these changes.

At this point in time, many of the regulations have not been finalized.  The Center for Food Safety and the Center for Environmental Health (public interest advocacy groups) have filed a lawsuit against FDA for failure to implement FSMA and failure to issue its associated final regulations by the deadlines mandated by the Act.

Despite much industry discussion regarding the delays in FSMA implementation, several important FSMA regulations have actually been issued, including the requirement for food facility registration renewals. FSMA mandates all food facilities to renew their registration with FDA between October 1 and December 31, 2012.  Food facilities that fail to renew may find their registration suspended and will be unable to ship to the United States.  Registrar Corp can assist companies with the complicated renewal process, serve as U.S. Agent, and ensure that their registration is complete.

During this renewal process, FDA requires facilities to “consent to FDA inspections.” FDA is increasing the number of food facility inspections abroad.  FSMA requires the FDA to double the number of foreign food facility inspections every year for the next 5 years. This results in an increase from 600 inspections in 2011 to 19,200 in 2016.  Under FSMA, inspections that identify noncompliance materially related to food safety may now result in FDA assessing reinspection fees, without limit, at rates of $289 per hour and $221 per hour, outside and inside the U.S., respectively.   Registrar Corp offers a pre-inspection assistance service to its clients to help them prepare for an FDA food facility inspection and minimize the risk of reinspection and associated fees.

For more information about the Food Safety Modernization Act (FSMA) or any FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

Read more about the Top New Requirements Food Industry Professionals need to know about FSMA