Food Safety Consulting Services

New food products, new packages and new methods of distribution and consumption have presented a variety of food safety issues, such as:

• Sanitation
• Equipment
• Environmental monitoring
• Foreign supplier verification plans
• Intentional adulteration
• Root cause analysis
• Raw materials
• Supplier risk assessment

The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) each have a unique responsibility for food safety. The FDA is the agency of the U.S. Department of Health and Human Services (DHHS) responsible for the safety of all food products and ingredients, except foods regulated by USDA’s Food Safety and Inspection Service (FSIS), which is responsible for the safety, wholesomeness and accurate labeling of meat, poultry and egg products. All food establishments, whether FDA- or USDA-regulated, are required to maintain sanitary conditions to ensure the safe production of food.

The Foreign Supplier Verification Program is a Food and Drug Administration (FDA) program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling. USDA is exempt from FSVP importing requirements.

For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of the consignee at the time of entry, as confirmed in a signed statement of consent.

The FSVP applies to anyone who is importing food or beverages for human or animal consumption. It can be the importer, broker, warehouse, or manufacturer. See the Am I Subject to FSVP? guide from the FDA for more information.

Certain categories of food and importers are exempt from the Foreign Supplier Verification Program (FSVP) rules and regulations. These exemptions include:

• Juice and seafood products that are subject to FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations.
• Meat, poultry, and egg products regulated by the USDA.
• Food imported for research or evaluation purposes
• Food imported for personal consumption.
• Alcoholic beverages and specific ingredients used in alcoholic beverages
• Food that is transshipped or exported.

The rule requires importers to perform risk-based foreign supplier verification activities to verify that:

• The food is produced in a manner that provides the same level of public health protection as section 418 (concerning hazard analysis and risk-based preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs) of the FD&C Act (21 U.S.C. 350g and 350h), if applicable;
• The food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and
• The human food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (concerning food allergen labeling).

• Determining known or reasonably foreseeable hazards with each food
• Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance;
• Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities;
• Conducting supplier verification activities;
• Conducting corrective actions; and
• Must have an FSVP Plan in place (and developed by a qualified individual) prior to bringing food or beverages into the USA.

An importer must evaluate

• 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; and
• Other factors as necessary, including storage and transportation practices.

The importer can rely on another entity (other than the foreign supplier) to perform the evaluation of risk, so long as the importer reviews and assesses the relevant documentation.

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. FSVP requires annual reviews or, as needed, for any corrective actions, such as import alerts.