Written by Stacy Telfer, Esq.
On January 4, 2011, President Obama signed into law the Food Safety Modernization Act (FSMA), the most far-reaching reforms to U.S. food safety laws since passage of the Food Drug & Cosmetic Act of 1937. The FSMA aims to ensure the safety of the U.S. food supply by a focus on preventing, rather than responding to, the problem of food contaminations.
As the agency charged with regulating U.S. food laws, the Food and Drug Administration (FDA) has issued several rules of importance to suppliers of domestic and imported foods. One component of the FSMA which specifically affects importers is the Food Safety Verification Program (FSVP). The FSVP requires importers to ensure that their food suppliers are providing them with quality food that is in compliance with the new safety requirements. Below is an overview of the FSVP and how it affects importers:
Who is an Importer?
The FDA defines an importer as a “U.S. owner or consignee of a food offered for import into the United States.” This means that an importer is a person or entity who brings human and animal food into the U.S. from a foreign country for trade or sale. The FDA’s definition of an importer does not apply to someone who imports food for personal consumption.
Key Requirements of the FSVP
Importers are required to develop, maintain, and follow a Food Safety Verification Program for each food imported and for each supplier associated with that food. Importers are being charged with a greater responsibility for ensuring that the food that enters the United States is not adulterated (contaminated) or mislabeled (with respect to allergen labeling). As such, importers must provide oversight to their suppliers’ supply chain. They must assess whether these suppliers are “producing food in a manner that provides the same level of public health protection as the [FDA’s] preventive controls.”
These preventive controls include the following action steps:
- Perform a Hazard Analysis to determine known or reasonably foreseeable hazards with each food.
- Evaluate the food risks based on the hazard analysis and the supplier’s performance.
- Use the risk evaluation to approve suppliers and determine appropriate supplier verification activities.
- Conduct supplier verification activities through audits, sampling and testing, review of food safety records, etc.
- Conduct corrective action if there is a problem, which could include discontinuing use of the foreign suppliers.
When executing the above tasks, importers are required to create a written plan. They must keep records to show that their suppliers have met the FSVP requirements. These records are subject to FDA inspection or third-party audits at any time.
Importer Preparation Checklist
Generally speaking, importers have until July, 2017 to comply with the FSVP. Specific due dates vary for actual importers, based on the size of the importer’s facility. Here is a non-exhaustive list of proactive steps importers can take now to get in compliance before the deadline:
- Check to see if your foreign food suppliers are on an import alert or have a history of FDA violations.
- Review your current food safety plans and begin drafting FSVP-compliant plans.
- Begin your record-keeping/documentation process.
- Perform verification activities such as on-site audits, sampling and testing of supplier’s foods, and/or review of suppliers’ food safety records.
- Stay informed of any new potential risks that could be associated with the food you import.
Invest the time and money necessary to get into compliance and to avoid expensive mistakes. Making sure your products comply with FDA regulations BEFORE your first post-FSVP shipment to the United States is much cheaper than having your food product detained at the border!
Contact us if you need help with your plan, or to learn more about how the FSMA and its FSVP requirements affect you.