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etyU.S. FDA Proposes New FSMA Food Safety Regulations (Part 1 of 3)

On July 26th, the U.S. Food and Drug Administration (FDA) released two new proposed rules for the food and beverage industry as part of the Food Safety Modernization Act (FSMA) regulations. The long awaited proposed rules detail the Foreign Supplier Verification Programs (FSVP) for Importers of Food for humans and animals and the Accreditation of Third-party Auditors. In an effort to help food and beverage companies understand the new FDA requirements, Registrar Corp will produce a three-part series on FDA’s new proposed rules.

FSMA, signed into law in 2011, enables FDA to take a more proactive approach to food safety. With the goal of preventing food safety outbreaks before they occur, FDA’s proposed FSVP rule requires food importers to take more responsibility for the food they import into the U.S. This is a paradigm shift from the past. Until 2011, the onus was on the FDA to inspect food at the port and ensure that it was safe.

Under the proposed FSVP regulations, an importer (unless otherwise exempted) would be required to develop, maintain, and follow an FSVP for each food it imports, which, in general, would need to include the following:

• COMPLIANCE STATUS REVIEW: Importers would be required to review the compliance status of the food and the potential foreign supplier before importing the food and periodically thereafter. Such review would need to include any FDA warning letters, import alerts, and requirements for certification issued by the FDA under section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act).

• HAZARD ANALYSIS: Importers would be required to analyze the hazards associated with each food they import. The hazard analysis would identify the hazards that are reasonably likely to occur for each type of food imported, and evaluate the severity of the illness or injury if such a hazard were to occur.

• VERIFICATION ACTIVITIES: Importers would be required to conduct activities that provide adequate assurances that the hazards identified as reasonably likely to occur are adequately controlled. Verification activities could include: onsite auditing of foreign suppliers; periodic or lot-by-lot sampling and testing of food; and periodic review of foreign supplier food safety records; or other appropriate risk-based procedures. Verification activities applicable to all FSVPs, regardless of identified hazards, include maintaining a written list of foreign suppliers from which food is imported, and establishing and following adequate written procedures for conducting verification activities.

• CORRECTIVE ACTIONS: Importers would be required to review complaints they receive concerning the foods they import, investigate the cause or causes of adulteration or misbranding in some circumstances, take appropriate corrective actions, and revise their FSVPs when they appear to be inadequate.

• PERIODIC REASSESSMENT OF THE FSVP: Importers would be required to reassess their FSVPs within three years of establishing the FSVP or within three years of the last assessment. However, importers would have to reassess the effectiveness of their FSVP sooner if they become aware of new information about potential hazards associated with the food. Examples of such information might include information on changes to the source of raw materials or to product formulation.

• IMPORTER IDENTIFICATION: Importers would be required to obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number for their company and to ensure that, for each food product offered for importation into the United States, their name and DUNS number are provided electronically when filing for entry with Customs and Border Protection.

• RECORDKEEPING: Importers would be required to keep certain records, including those that document compliance status reviews, hazard analyses, foreign supplier verification activities, investigations and corrective actions, and FSVP reassessments.

The proposed program for the accreditation of Third Party Auditors will allow for bodies other than the FDA to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. These certifications will not be mandatory; rather importers can voluntarily undergo these audits. In certain circumstances, FDA may use these third party certifications to determine whether to admit certain imported food into the U.S.

The FDA would require accredited auditors to:

• ensure their audit agents are competent and objective;
• conduct rigorous audits;
• submit reports of audits used for certification purposes (called regulatory audits) to the FDA;
• notify the FDA upon finding any condition posing a serious risk to the public health;
• assess and correct any problems in its own performance;
• protect against conflicts of interest; and
• maintain and provide the FDA access to records.

FDA’s draft rules are not yet finalized. FDA will take comments from industry for 120 days. It is not until after the comments have been reviewed that FDA will finalize the rules.

As a FDA regulatory compliance firm, Registrar Corp assists companies with Food Facility Registrations, Renewals, and U.S. Agent requirements. Registrar Corp’s Food Safety Department also performs Mock FDA Inspections of facilities to help companies prepare for U.S. FDA inspections. FSMA requires FDA to inspect foreign food facilities and to double the number of inspections every year until 2015. This year alone, FSMA requires FDA to perform a minimum of 2400 inspections of foreign facilities. Prepare now for a U.S. FDA inspection.

Registrar Corp will continue to keep industry updated on changes to U.S. FDA requirements in order to help food and beverage exporters to understand and comply with U.S. FDA regulations. For more information on how the Food Safety Modernization Act may affect you, Registrar Corp is available by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive regulatory updates, visit: FDA Regulatory Updates by Registrar Corp.

Continue Reading this series:

U.S. FDA Proposes New FSMA Food Safety Regulations – Part 1
U.S. FDA Proposes New FSMA Food Safety Regulations:  Foreign Supplier Verification Program (FSVP) – Part 2
U.S. FDA Proposes New FSMA Food Safety Regulations: Third Party Auditors – Part 3





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