We continue to do blogs on the importance of food safety and the regulatory environment that we, as a food-manufacturing ecosystem, find ourselves. Products come into the United States from all over the world and from many different cultures with many different ways to process food. In September of 2018 FDA produced an introduction in which the beginning stated:
“The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.”
Foreign supplier verification is a method for assuring that these products from all over the world adhere to the best practices and regulation being implemented in the United States. We will be walking you through the fundamentals as listed on the FDA website. These areas include:
• Hazard Analysis
• Evaluation of Food Risk and Supplier Performance
• Supplier Verification
• Corrective Actions
• Exemptions and Modified Standards
• Unique Facility Identifier
Each of these areas is define as a key requirement and we will walk through some of the basics included. A comprehensive overview can be found at https://www.fda.gov/food/guidanceregulation/fsma/ucm361902. connectfood.com is not here to interpret guidance but is here to help food manufacturers and importers on their journey towards a globally safe food supply.
The scope covers making sure that an importer understands the responsibility of food safety. The importer must collect the information that they will have to provide regarding the safety of incoming products. The companies that are shipping products into the country must have food safety plans for the incoming products that matches the current standards of preventive controls and produce safety.
“Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.” FDA.gov
The scope is not a simple process and it requires detailed information reaching into countries across the globe.
The importer must understand what reasonable hazards are like likely to occur in a food and make sure that these hazards are addressed by a food safety plan and controls. The importer does not necessarily have to “do” the hazard analysis but must be able to review the documents that have been done by a qualified individual assuring the safety of the food. Ultimately the importer is the gatekeeper of food safety for products that are coming into the country.
Evaluation of Food Risk and Supplier Performance
There is a set list of task that an importer must look at to help assure supplier performance and this will allow them to understand what the companies supplying products are doing to protect the integrity of the food supply. The below points are straight from the FDA website mentioned above:
• The hazard analysis
• The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier’s raw material or ingredient supplier
• A foreign supplier’s procedures, processes and practices related to the safety of food,
• Applicable FDA food safety regulations, and information regarding the foreign supplier’s compliance
• The foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems
• Other factors as necessary, including storage and transportation practices
An importer must be confident that that a supplier is doing the right thing and has a food safety plan that has analyzed hazards and controlled them. There different ways to go about this including annual audits by a qualified individual, sampling and testing. Review of the food safety plan by outside experts and the supplier.
“What supplier verification activities must be conducted? Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.” FDA.gov
If something happens that is outside of the food safety plan the issue must be evaluated and decided if the product is a danger to the consumer. When this happens it must be decided what to do with the product and how much product was adulterated and where that product is in the supply chain. This will also impact if the supplier should continue to be used by the importer.
“The appropriate corrective measure will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.” FDA.gov
Exemptions and Modified Standards:
The exemptions are listed on the FDA website and should be reviewed; however, it is our viewpoint that all products should have GMP’s and a food safety plan. Some of these exemptions could include the size of the establishment or the type of product being supplied such as dietary supplements but all of these products must be evaluated by the importer and compared with the FDA requirements.
Unique Facility Identifier
The FSVP rule requires information about importer and the products that are coming into the country so that if there is an issue it can be stopped and contained before there are any human health issues. Below is some of the information from the FDA.
• The final FSVP rule requires that an importer provide its name, electronic mail address, and unique facility identifier (UFI) recognized as acceptable by the FDA for each line entry of food product offered for importation into the United States.
• The FDA has recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.
• DUNS numbers, assigned and managed by DUN & Bradstreet, are available free of charge to importers by visiting FDAdunslookup.com.
In conclusion, the FSVP Rule is set up so that there are checks and balances for the importers and the companies that are supplying them from all over the world. The FSVP requirements are right in line with the rest of the Food Safety Modernization Act that is assuring the safety of consumers and protecting the safest food supply in the world. Remember, as an importer you must understand risk associated with the products coming in and understand what is being done by the supplier to control any hazards. It is the importer’s job to set up a system that complies with the above points.
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About the Author
Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.