FDA Proposes New Foreign Supplier Verification Program

August 28, 2013

 

The U.S. Food and Drug Administration (FDA) is proposing to adopt new regulations requiring importers of food for humans and animals to adopt foreign supplier verification programs (FSVPs). As published in the July 29, 2013 Federal Register, the regulations are being proposed to ensure food imported into the U.S. is processed using U.S. standards. Written comments on the proposed rule are due by November 26, 2013.

The regulations will require importers to implement FSVPs for their foreign suppliers, meaning importers will be responsible for ensuring that foreign suppliers execute practices that align with the FDA’s framework for food safety, prevention of adulteration and labeling compliance. The proposed rule would establish modified FSVP requirements for very small food importers and importers of food from very small foreign suppliers. Exemptions also exist for certain food products and products that are not entered for consumption in the United States.

The regulations are said to focus on identifying foreseeable food safety risks through a hazard assessment process, rather than attempt to cover all possible risks covered by the adulteration provisions in section 402 of the Food, Drug & Cosmetic Act.

The specifics of the FSVP would vary depending on the food product, and are intended to assure that foreign food suppliers use the same processes and preventive controls as their American counterparts under the Food, Drug and Cosmetic Act. Under the regulations, onsite audits of foreign suppliers would be required, but some importers, depending on the product, could conduct lot-by-lot sampling and testing and safety record reviews.

Elements of the Foreign Supplier Verification Program

The proposed FSVP regulations would require importers to:

(1)       Review the compliance status of foods and potential foreign suppliers, including whether either is the subject of an FDA warning letter, import alert, or certification requirement relating to the safety of the food. These documents are or would be available at FDA’s web site.

(2)       Determine the hazards reasonably likely to occur with each food. Importers would need to conduct their own analysis of the potential hazards with a food or review and evaluate the hazard analysis conducted by the food’s foreign supplier.

(3)       Conduct supplier verification activities. Importers would need to maintain a written list of foreign suppliers and establish written verification procedures. Importers would need to verify that hazards identified as reasonably likely to occur in a food they import are being adequately controlled. If the importer or its customer is controlling a hazard, the proposed rule would require the importer to document such control.

(4)       Review complaints, investigate adulteration or misbranding (with respect to allergen labeling), and take corrective actions in the case of supplier noncompliance.

(5)       Reassess the effectiveness of its FSVP when the importer becomes aware of new information about potential hazards associated with a food or otherwise every three years.

(6)       Ensure that the importer’s name and Dun and Bradstreet Data Universal Numbering System (DUNS) number is provided for each line of entry of food.

(7)       Maintain records of their FSVP activities.

Supplier Verification Options

For supplier verification activities, the proposed rule presents two alternative proposals:

Under Option 1, onsite auditing of the foreign supplier would be required for hazards when there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death. Onsite auditing also would be required for microbiological hazards in certain raw agricultural commodities (RACs) that are fruits or vegetables.

For other hazards, including less serious hazards, importers would have the flexibility to choose the verification activity or activities that will provide sufficient assurance that the hazards are adequately controlled, such as: periodic or lot-by-lot sampling and testing, periodic review of the supplier’s food safety records, and any other procedure that an importer has established as being appropriate to verify adequate control of a hazard.

Option 2 would allow importers to choose from among the above verification activities for all types of hazards not controlled by the importer or its customer.

Additionally, certain exemptions from the FSVP are provided, including some juices, fish and fishery products (which are already subject to the FDA's Hazard Analysis & Critical Control Points regulations), food for personal consumption, alcoholic beverages, food that stops at other ports before arriving in the U.S., food that is imported for re-export and food for research or evaluation.

The FDA has proposed an amendment to its regulations "to provide accreditation of third-party auditors/certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications under the FDA Food Safety Modernization Act.”

Imports from Very Small Food Importers or Suppliers

The proposed rule would establish modified FSVP requirements for very small food importers and importers of food from very small foreign suppliers (i.e., entities with annual food sales of no more than $500,000).

Because of the relatively small volume of food imported by and from these entities, which FDA said should reduce consumers’ exposure to, and therefore potential risk from, the imported food, the FDA is proposing that in these situations the importer would not be required to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurance that describes the processes and procedures the suppliers use to ensure the safety of the food.

Imports of Dietary Supplements and Dietary Supplement Components

For dietary supplements and dietary supplement components, importers who establish and verify compliance with certain specifications (concerning dietary supplement components, labels, packaging, and labeling) under the dietary supplement CGMP regulations would not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. On the other hand, importers of finished dietary supplements would be required to comply with most of the standard FSVP requirements, but they would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier is in compliance with the dietary supplement CGMP regulations, rather than verifying that hazards identified as reasonably likely to occur are being adequately controlled.

Imports from Countries with Similar U.S. Food Safety Controls

The proposed rule would exclude from most of the standard FSVP requirements (including hazard analysis and verification that identified hazards are adequately controlled) food from a foreign supplier in a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, provided certain preconditions are met.

Additional Information

A copy of the Federal Register notice can be viewed at our website at www.tuttlelaw.com/customs_material/2013-17993.pdf.

A more extensive Preliminary Regulatory Impact Analysis for the proposed rules on Foreign Supplier Verification Programs (Docket No. FDA-2011-N-0143) is also available on our website at:  www.tuttlelaw.com/customs_material/ucm363286.pdf.

If you are interested in how this rule will affect your company or your activities, please contact George Tuttle III at george.tuttle.iii@tuttlelaw.com or (415) 986-8780. 

George R. Tuttle, III, is an attorney with the Law Offices of George R. Tuttle in San Francisco.

The information in this article is general in nature, and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence, and may not be considered as such.

 

Copyright © 2013 by Tuttle Law Offices. 

All rights reserved.  Information has been obtained from sources believed to be reliable.  However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.

 

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