The FDA Food Safety Modernization Act was enacted by the U.S. Congress and signed into law by President Obama on January 4, 2011. This law creates the most significant changes to the U.S. food production and distribution system in more than seventy years. It imposes broad new requirements on manufacturers, processors, packers and distributors of food, and grants U.S. FDA sweeping new enforcement powers. To assist food industry professionals, Registrar Corp has analyzed the new law and provides the following information that all food industry professionals should know about the new law:
1. Most of the provisions of the new law require U.S. FDA to issue regulations providing the details. The specific requirements will depend on these regulations to be issued over the next two years. Registrar Corp will provide updates as these regulations are issued.
2. Commencing in October 2012, each food facility must renew its U.S. FDA registration biennially (every two years). Registration renewal will be required during the 4th quarter of every even-numbered year (i.e., 2012, 2014, 2016, etc.). Facilities located outside the United States will still be required to designate a U.S. Agent for U.S. FDA communications, as established by the U.S. Bioterrorism Act of 2002.
3. The law grants power to U.S. FDA to suspend a company’s food facility registration if U.S. FDA believes that food manufactured, processed, packed, received, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Additionally, the law authorizes U.S. FDA to administratively detain articles of food believed to be misbranded or adulterated. The law also grants U.S. FDA the power to order, rather than merely request, the recall of tainted food.
4. As part of each company’s food facility registration, the company will be required to agree to permit inspection by U.S. FDA. The law does not require U.S. FDA to inspect all facilities, but it increases the number of inspections and requires all firms to agree to an inspection upon U.S. FDA request. A company may be required to pay for any required re-inspection.
5. The law imposes new requirements on persons designated in food facility registrations as U.S. Agents for food facilities located outside the United States. The U.S. Agent is now obligated to pay the cost of foreign food facility re-inspections (billed at $325/hour if foreign travel is required).
6. The law directs U.S. FDA to hire a significant number of new field staff to carry out its purposes between now and 2014. FSMA mandates that U.S. FDA hire thousands of new employees, including a special unit dedicated to detecting and tracking threats such as “smuggled food.” The law defines “smuggled food” as “any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead.”
7. Food facilities will be required to develop written plans for hazard analysis, preventive controls and corrective measures, to be updated with each change in operations or every three years, whichever is more frequent. These records must be available for U.S. FDA inspection. Specific regulations will be promulgated by U.S. FDA. Small businesses may be exempt from the more stringent of these requirements. A small business is defined as one with sales of less than $500,000 per year, which must be mostly to local restaurants or retailers and to consumers. The upcoming regulations will provide details.
8. Importers will be required to establish programs to verify the safety of all shipments of imported food, and U.S. FDA may require certifications of safety for each shipment. Regulations implementing these requirements were due by January 4, 2012. U.S. FDA may establish a Qualified Importer program, easing requirements for some importers, by July 4, 2012.
9. U.S. FDA will provide for the recognition of accreditation bodies that accredit laboratories, including laboratories outside the United States, with a demonstrated capability to conduct analytical testing of food products. Regulations implementing this provision are due by January 4, 2013.
10. Registrar Corp will be available to assist you as each of these new requirements takes effect and as new regulations are promulgated. For more information about new FDA FSMA regulations or any existing FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.
To view the full text of the FDA Food Safety Modernization Act, click here.