In 2011, Congress Passed the Food Safety Modernization Act (FSMA), which included the directive to create a food safety system in which the focus should shift to the prevention of contamination rather than primarily reacting to problems after occurring. The FSMA rules apply to food establishments that manufacture/process, pack, and hold human and animal foods, and establish science-based standards for produce grown on farms. These rules apply to domestic food producers and those in other countries who export to the United States and its territories.
One of the rules the FDA has established is the Foreign Supplier Verification Program (FSVP), which requires food importers to verify that the food they import meets the U.S. safety standards. The importers are required to develop, maintain, and follow the FSVP for each food imported unless an exemption applies. Each food imported into the United States is identified by the FSVP importer who takes responsibility for meeting the FSVP requirements.
Some of the key requirements of the FSVP rule include the following for each imported food:
- Use a qualified individual to develop the FSVP.
- Complete a hazard analysis that identifies known or reasonably foreseeable hazards.
- Determine whether the hazard requires a control. Potential hazards include:
- Harmful bacteria
- Pesticide and drug residues
- Natural toxins
- Food decomposition
- Unapproved additives
- Food allergens
- Nutrient deficiencies or toxicities
- Physical hazards
- Hard plastic
- Evaluate the risks posed by the food and the performance of the foreign supplier. Consider these:
- The above hazard analysis
- The company/entity implementing/managing the hazard controls
- The foreign supplier’s food safety practice and procedures
- The degree of compliance to U.S. food safety regulations, practices, and procedures
- Whether the foreign supplier is subject to an FDA warning letter or import alert
- The results of the foreign supplier performance history/records review
- Conduct ongoing supplier verification activities to provide assurance that the identified hazards have been significant minimized or prevented. These activities can include:
- Annual onsite auditing performed by a qualified auditor
- Sampling/testing of the food
- Reviewing relevant food safety records
- Take corrective action as necessary
- Reevaluate the food and foreign supplier at least once every three years or less, if the FSVP importer learns of new hazards in the food or changes in the foreign supplier’s performance.
Adroit North America can help your company develop or improve upon a systemic approach that establishes effective supply chain preventive controls, improved supplier performance, and management of information, food safety system records and notifications. Key activities we typically get involved with include:
- Collaborate with your team to develop a full working knowledge of the Food Safety Modernization Act (FSMA) requirements including the FSVP rule.
- Review your supply program and determine what foreign supplier verification programs (FSVP) you are required to have
- Assess your ingredients and raw material’s risk assessment considering biological, chemical, allergens, radiological and physical hazards
- Conduct a Supplier Risk Assessment considering your food safety system performance and other supply chain aspects
- Assess the efficacy of your current Supplier QA program, for the process for approval, verification activities, ongoing approval, and removal of suppliers to guarantee that the Food Safety and Quality System fulfills food safety, product quality, food defense and food fraud expectations
- Conduct on-site or remote audits, verifying your foreign suppliers’ food safety and quality programs to ensure the hazards requiring a supply-chain-applied control for the raw material or other ingredient have been significantly minimized or prevented
- Review your supplier’s relevant food safety system records and conduct other appropriate supplier verification activities based on supplier performance and the risk associated with the raw material or other ingredients
- Establish proper FSVP electronic record keeping and reporting into your ERP – such as Aptean Food and Beverage ERP JustFood Edition and/or other food safety systems of record
Food Safety Modernization Act (FSMA); CFR Code Federal Regulations Title 21, part 117—Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls for Human Food, Subpart L – Foreign Supplier Verification Programs for Food Importers.
www.fda.gov – fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.