Product Recall, Business Insurance

FSVP Is In Effect! Are You Ready?


Authored by an industry leader:

Joel Berrian, CPCU, ARM, AIC

The latest FSMA regulation goes into effect today. While the effective date has been calendared for quite some time, some confusion still exists about the Rule and what efforts companies should undertake to meet FSVP’s first major compliance date.

The great news: the FDA continues to reach out to companies to assist with regulation compliance. Moreover, the FDA understands that the FSVP regulations are new to companies and are taking an educational approach in order to create a culture of compliance. Use this opportunity to understand the Rule and what efforts your team needs to undertake to comply.

Generally, understand the basis for FSVP: the Rule has been implemented to assure that imported foods, including their ingredients, meet the same levels of food safety or public health protection as food produced in the U.S. In other words, FSVP is here to assist your foreign-related supply chain in reaching and maintaining the same standards required domestically under FSMA.

Here are a few very basic ideas to assist your FSVP efforts:

  • ŸComprehend the basic definitions: “importer”, “foreign supplier”, “qualified individual”, etc.
  • Communicate with your supply chain partners about FSVP responsibilities
  • Understand what is and is not covered under the Rule
  • Recognize what is required under YOUR foreign supplier verification program
  • Create a company culture of compliance:
    • Develop a written, easy to understand program
    • Create a global schedule of importers and suppliers
    • Ensure continuous follow up with your supply chain partners
    • Implement an alert/notification system
    • Develop record keeping procedures (Remember: 2 years/24 hours)
  • Get it all written down – if it’s not documented, it didn’t happen
  • Conduct a gap analysis
  • Review and practice

Remember, the Rule’s first compliance date is here and the related regulations are now in effect. The FDA is taking a helpful, educational approach to the new regulations in order to assist your compliance efforts. Take advantage of the FDA’s perspective and make sure that your team is working towards full compliance. Companies can also gain assistance by working with ReposiTrak and FMI, which have experts to assist your compliance efforts. A window of opportunity exists so make the most of it!

Joel Berrian is co-owner of Berrian Insurance Group and specializes in insurance for large risks with complex exposures such as mining and energy, product and professional liability, catastrophe exposed property, food and beverage, and global cargo and marine.