FDA Now More Proactive in Food Safety
The U.S. Food and Drug Administration Now More Proactive in Food Safety
As FDA becomes more proactive, food companies will have to adhere to stricter food safety standards.
In 2011, the U.S. Congress passed the U.S. Food Safety Modernization Act (FSMA) with the purpose of changing the approach of U.S. Food and Drug Administration (FDA) policies from “reactive to “proactive” in nature. In the past, FDA spent much of its efforts mitigating the effects of food-borne crises. Under FSMA, FDA will attempt to prevent food-borne crises from ever occurring in the U.S. In order to accomplish this, FSMA allows FDA to require that food facilities maintain stricter preventive control measures to ensure food safety. FSMA also establishes two new programs for importers: the Foreign Supplier Verification Program (FSVP) and the Voluntary Qualified Importer Program (VQIP). These new regulations will result in foreign companies having to comply with stricter standards in order to export food and beverages to the United States.
FSMA will require all food facilities that manufacture, process, pack, or hold food that will be consumed in the United States to develop comprehensive, preventive-based controls across their food supply chain. Facilities will be required to identify hazards, establish and monitor preventive controls, and record and document their food safety plan. While food facilities will still be required to comply with Current Good Manufacturing Practices (CGMPs), FDA intends for preventive controls to expand on CGMPs.1
Preventive controls are risk-based, scientific steps that a food facility would take to prevent or significantly minimize the likelihood of problems occurring. Once preventive controls are in place, facilities will be required to monitor them to verify that they are working as they were designed. FDA will require food facilities to maintain written records of their preventive control plans; these plans must be updated with each change in operations or every three years, whichever is more frequent. In addition, written records of compliance must be available for FDA inspection. Food facilities are required to keep these records for at least two years.
FDA will also require importers to participate in the Foreign Supplier Verification Program (FSVP) to ensure imported food is not adulterated and is in compliance with FDA’s safety standards and control requirements. An “importer,” for the purposes of this program, is defined as the United States owner or consignee of the article of food at the time of entry of such articles into the United States, or, if there is no United States owner or consignee, the importer is defined as the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry into the United States.
FDA will require importers to establish programs to verify the safety of all shipments of imported food and may also require certifications of safety for each shipment. FDA will take into account the different risk-levels of imported food, but all importers will be required to participate in FSVP. Under FSVP, importers may verify shipments by monitoring records of shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments. FSVP requires importers to perform these verification activities for the purpose of verifying that the food imported is produced safely, unadulterated, and not misbranded. The specific regulations on safety certification in FSVP have yet to be promulgated by FDA.
FDA is required to publish and maintain a list of FSVP participants that will display, at a minimum, the name and location of suppliers in the program. Products that are excluded from FVSP include seafood, juice and low-acid canned food products, which already comply with HACCP regulations, and small quantities of food imported for research or personal consumption. Regulations implementing these requirements were due on January 4, 2012, but FDA has yet to release these regulations.
Unlike the FSVP, the Voluntary Qualified Importer Program (VQIP) is an entirely voluntary program established to expedite the process of importing food to the U.S. from the list of importers participating in VQIP. FDA will qualify importers based on risk-level and certification. To be eligible to participate in VQIP, FDA will require that companies be certified by an accredited third party. FDA must approve the accredited third parties. These third parties will accredit laboratories both inside and outside of the U.S. that demonstrate the capability to conduct analytical testing of food products. VQIP will also establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in the program. Under this program, an “importer” is defined as the person that brings food, or causes the food to be brought, from a foreign country into the United States. This is an important distinction from the definition of an importer under FSVP because it could mean that foreign manufacturers may be allowed to participate in this program. As with all new requirements under FSMA, the deciding factors will not be known until the final regulations are issued. Indeed, FSMA does not define details of entities that are or are not allowed to participate in VQIP, nor does it outline the specific benefits and advantages of participating. FSMA merely states that importers may request to participate and that participation will provide an expedited review process. Regulations implementing this provision are due by January 4, 2013.
Both FSVP and VQIP identify importers as the front line of contact for food safety awareness and hazard prevention. FDA has indicated that these two programs are of top priority amongst all new FSMA requirements as the two programs were key components discussed during FDA’s first series of Public Meetings. FDA intends FSVP and stricter preventive controls to prevent future industry crises. As FDA promulgates further regulations, Registrar Corp will be available to answer any questions foreign companies may have about U.S. FDA compliance.
For more information about FSMA and any other FDA regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.
1“Frequently Asked Questions on Imports.”The U.S. Food and Drug Administration.14 June 2012. The U.S. Department of Health & Human Services. 29 June 2012 <http://www.fda.gov/Food/FoodSafety/FSMA/ucm247559.htm>
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