Food & Bev

FSMA Foreign Supplier Verification Rule: What Manufacturers Need to Know Now

Food Manufacturing • Randy Fields

It's a new world for any company manufacturing food products for sale in the United States.

As part of the Food Safety Modernization Act (FSMA), all importers of foreign food must maintain a Foreign Supplier Verification Program (FSVP) that ensures each imported item is produced in compliance with processes that meet the FDA's standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis. The supplier's record of compliance is also considered along with a renewed analysis every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Here's what you need to know:

1. There Are New Rules Defining Who Is An Importer Under FSMA's Foreign Supplier Verification Rule

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the U.S. from any other country at the time of U.S. entry. And it's likely that there may be more than one entity considered the importer. If you are still unsure as to whether you are the importer, try answering the questions below. If you answer "me" to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who is in the best position to assure the foreign supplier produces food that meets U.S. standards and is as safe as food produced by a U.S. supplier?
  • Who is most likely to have knowledge of food safety practices?
  • Who controls the supply chain of an imported food?
  • Who controls the finances of the imported food (owner or consignee)?
  • Who controls the goods? Whose truck picks it up or in whose distribution center is the product stored?
  • Who can best ensure that supplier verification activities are conducted for each food imported into the U.S.?

2. It Is Critical To Know What Comprises A FSVP Program

The new regulation puts the burden of proof on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP program in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file. (Hint: it's a good idea to trust, but verify in this situation.)

3. You Will Need To Meet The FSVP Challenge

Any record requested by the FDA must be available within 24 hours and could go two years back. If you don't have an automated system, it's time to consider one, as it's really the only way to manage the range of documents required by FSVP across a retailer's or wholesaler's vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. The CEO's Responsibility Under FSVP Has Expanded Dramatically

Senior executives in the extended retail food supply chain are personally responsible not only for their company's compliance with FSVP, but also for verifying the compliance of the company's upstream supply chain.

5. Now Is The Time To Take Action

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While most like to think that providing safe food is just the right thing to do, there's an obvious competitive advantage for those foreign suppliers who are able to meet the requirements, thereby making themselves more desirable in the supply chain. So it's critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.

The information contained in this article is intended for general information purposes only and is based on information available as of the initial date of publication. No representation is made that the information or references are complete or remain current. This article is not a substitute for review of current applicable government regulations, industry standards, or other standards specific to your business and/or activities and should not be construed as legal advice or opinion. Readers with specific questions should refer to the applicable standards or consult with an attorney.


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