U.S. FDA Proposes New FSMA Food Safety Regulations–Foreign Supplier Verification Program (FSVP) (Part 2 of 3)
On July 26, 2013, FDA issued two new proposed regulations in accordance with section 301 of the Food Safety Modernization Act (FSMA): Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (1) and the Accreditation for Third-Party Auditors/ Certification Bodies to Conduct Food Safety Audits and To Issue Certifications (2). These new proposed rules follow two proposed rules issued by FDA on January 4, 2013: “Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice” and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” The four proposed rules are designed to work together to strengthen food safety in the United States. Accordingly, the proposed rules will impact almost all companies selling food in the United States. In this article, Registrar Corp discusses how FDA’s Proposed Rule for the Foreign Supplier Verification Program (FSVP) may apply to the food and beverage industry.
FDA is proposing to adopt regulations on foreign supplier verification programs (FSVP) for Importers of food for humans and animals. In the proposed rule, FDA defines an “Importer” as “the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee.” The FSVP regulation applies to all food offered for import in to the United States and to the Importers of such food EXCEPT for:
- Most imported juice, fish, and fishery products;
- Most imported small quantity shipments of food imported for research or evaluation;
- Most imported small quantity shipments of food that imported for personal consumption;
- Most imported alcoholic beverages;
- Most imported food that is transshipped or imported for further processing and export.
For non-exempt imported food, Importers must develop, maintain, and follow a FSVP that provides adequate assurances that their foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required currently required in the United States. A “qualified individual” must develop your FSVP and perform each of the required activities. A FSVP would include procedures such as for the following:
- Review of the compliance status of foods and foreign suppliers
- Analysis of hazards reasonably likely to occur with foods
- Determination and performance of appropriate foreign supplier verification activities for foods
- Review of complaints, investigation of adulteration or misbranding, and taking of corrective actions
- Reassessment of the FSVP
- Ensuring that required information is submitted at entry
- Maintenance of records
Before importing a food from a foreign supplier, an Importer must review the compliance status of the food and the foreign supplier to determine whether it would be appropriate to import food from the foreign supplier. This would require a review of (but not limited to) FDA Warning Letters, Import Alerts, FDA Form 483s, Establishment Inspection Reports (EIR), Recall Notices, and documents relating to injunctions or seizures. Importers must document this review. Further, Importers must continue to monitor and document the compliance status as long as you import the food from the foreign supplier.
For non-exempt imported food, importers must determine the hazards, if any, that are reasonably likely to occur with the food and, for each, the severity of the illness or injury if such a hazard were to occur. Importers must document this determination and use it to determine appropriate verification activities.
An importer’s evaluation of the hazards that are reasonably likely to occur with each imported must consider hazards that may occur naturally or may be unintentionally introduced, including the following:
- Biological hazards, including microbiological hazards such as parasites and environmental pathogens, and other microorganisms of public health significance;
- Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens;
- Physical hazards; and
- Radiological hazards.
Importers would be required to conduct the following foreign supplier verification activities:
- Maintain a written list of foreign suppliers.
- Establish and follow adequate written procedures for conducting foreign supplier verification activities with respect to their imported foods.
- For non-exempt imported food, Importers will be required to provide adequate assurances that identified hazards are adequately controlled.
- For hazards controlled by the Importer, the Importer must document, at least annually, that the Importer have established and are following procedures that adequately control the hazard.
- For hazards controlled by the Importer’s customer, the Importer must document that the customer controls the hazard by obtaining written assurance, at least annually, from the customer that it has established and is following procedures (identified in the written assurance) that adequately control the hazard.
- For hazards controlled or verified by the supplier, FDA proposes multiple verification options including (but not limited to) onsite auditing; lot-by-lot sampling and testing; review of the supplier’s food safety records.
If an Importer becomes aware that their imported food is adulterated, the Importer must promptly investigate the causes of such adulteration or misbranding and document any such investigation. This includes a review of any customer, consumer, or other complaint that Importers receive to determine whether the complaint relates to the adequacy of their FSVP. Importers must promptly take appropriate corrective actions if they determine that their foreign suppliers did not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as required. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. Importers must document such corrective actions.
The FSVP must undergo periodic reassessment by a qualified individual. The FSVP must be reassessed within three years of its establishment, three years of the last assessment, or sooner if new information indicates that a reassessment is warranted.
Importers must obtain a Duns and Bradstreet Data Universal Numbering System (DUNS) number for their company and to provide their name and DUNS number when electronically filing for entry with Customs and Border Protection.
Finally, Importers must maintain certain FSVP records:
- Records must be maintained in English and made available to FDA upon request. If requested in writing by FDA, an Importer must send records to FDA electronically.
- Importers must maintain FSVP records at their place of business or at a reasonably accessible location.
- FSVP records must be legible and stored to prevent deterioration or loss.
- FSVP records must be maintained for at least 2 years after their use is discontinued (e.g., because an Importer no longer imports a particular food, no longer import from a particular supplier, or an Importer’s FSVP procedures have changed).
- Importers must sign and date records concerning their FSVP upon initial completion and upon any modification of the FSVP.
The proposed regulation prohibits the importation (or offering for importation) of non-exempt food into the United States without a FSVP that meets the requirements. Importers that fail to comply with a FSVP may be subject to refusal of admission.
Registrar Corp will be providing additional information on the Foreign Supplier Verification Program and will alert industry when the final rule is published. Tweet Registrar Corp (@RegistrarCorp) if you have specific questions. Or, for any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.
About Registrar Corp: Registrar Corp is a FDA Compliance Agency that helps companies with U.S. FDA Regulations. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 19 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations. For immediate assistance with U.S. FDA Regulations, phone Registrar Corp: +1-757-224-0177 or receive online Live Help from our regulatory specialists.
1. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
2. Accreditation for Third-Party Auditors/ Certification Bodies to Conduct Food Safety Audits and To Issue Certifications
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