Originally printed in the January 2022 issue of Produce Business.
Despite a global pandemic that has claimed the lives of more than 5 million individuals and closed major economic sectors throughout the world, U.S. imports of fresh produce have increased, a tribute to the resiliency of the fresh produce industry. In just one year, trade statistics showed that U.S. imports of fresh and frozen fruits rose by 11%. The U.S. Department of Agriculture reports the value of fresh and frozen fruit imports was $16.7 billion in 2020, compared with $14.95 billion for the previous year.
Imports of fresh vegetables rose by 7%, according to the USDA. While U.S. imports of fresh vegetables were $9.78 billion two years ago, last year, the U.S. imported $10.47 billion.
Amid these increases, the FDA has stepped up its education and inspection efforts, especially for food importers that fall under the requirements of the Foreign Supplier Verification Program (FSVP) of the Food Safety Modernization Act (FSMA).
The agency now holds importers accountable for ensuring that food entering the United States meets the FDA’s standards. This creates a new role within import companies for a “Qualified Individual (QI)” to develop and review the preventive control and verification activities of an importer’s foreign suppliers. This new requirement poses a significant burden for mid-size and small import companies that do not employ a food safety professional familiar with FSVP or one who is simply overwhelmed by the task.
In 2021, the FDA performed an increasing number of FSVP inspections, most conducted on a remote basis. There was a significant increase in FDA Form 483s (a formal process of informing a firm of the FDA’s concerns that requires a timely response with corrective actions identified and taken) and warning letters issued. Many resulted from the importer’s failure to develop a Food Safety Verification plan. Failure to develop a plan may result in the importer’s product being refused entry.
The U.S. is not alone in these actions. Similarly, we have also seen increasing import enforcement from the Canadian Food Inspection Agency, in which Canadian importers have also been challenged to comply with the Safe Food for Canadians Regulations (SFCR).
To meet the compliance requirements for importers, QIs must not only understand the importing business and the rules of FSMA or SFCR, but they must also verify that their foreign suppliers are compliant. This comes with its own set of challenges because importers may have large numbers of international suppliers in multiple countries, each with different food safety cultures, languages, and modes of communication.
These QI-conducted verification activities are the most critical, because suppliers throughout the world face their own challenges. An example this year occurred in Haiti. Haiti is one of the top mango exporters in the world, but those exporters have faced difficulties achieving full compliance due to security issues that have delayed the implementation of growers’ food safety plans. Since most of the Haitian mango growers didn’t have food safety audit certifications in place, importers were challenged in completing their FSVP evaluations.
Both Qualified Individuals and the technologies they use are critical to meeting the requirements of FSVP. When outbreaks are identified, QIs will be crucial in helping to determine the specific lots of contaminated food and trace them back to their lot origin, a valuable asset when everyone is interested in identifying the source or narrowing the scope of a recall. The FDA has been advocating for new and smart food safety technologies to address these situations, especially leveraging technologies that already exist, such as shopper card data, barcodes from food packages, supplier-customer data, and purchase orders.
While we seem to be getting better at finding outbreaks and connecting them with specific types of foods, the quality and compatibility of this data are highly variable. According to the FDA, “streamlining pieces of data will help to identify outbreaks and trace the origin of a contaminated food to its source in minutes, or even seconds, speeding our response when public health is at risk.”
If QIs use platforms for food safety documentation that allow them to monitor their suppliers’ records and connect the dots within supply chains, they will be able to conduct real-time audits in places that would otherwise be unreachable. QIs using effective technology will be the key to getting help and guidance delivered to suppliers where being on-site was not possible before.
Cynthia Temblador, Regulatory Compliance & QA Manager at Azzule Systems LLC, has over 10 years of experience working in Food Safety and Quality Assurance in different food sectors.
Temblador has supported different companies throughout her career, including McDonald’s Mexico as the Food Safety and Quality Assurance Manager. She currently leads the Core Support program team and supports the PrimusGFS audit scheme’s technical team through the incorporation of international standards and produce industry requirements. In addition, in her time at Azzule Systems, she has provided technical support in the development of software compliance programs for different food sectors.
Temblador has a strong background in international food regulations, working to develop food safety programs to help various food industries comply with domestic and international regulatory agencies.