By Sam Lewis
On May 30, the FDA’s Foreign Supplier Verification Program (FSVP) went into effect. The legislation has meandering requirements and exemptions leaving some in the food industry befuddled about what to do to comply. Here, Dr. Janie Dubois, director of the laboratory program at the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), answers my questions on FSVP requirements, some misconceptions of FSVP, as well as the role it plays in laboratory testing. Dubois will be speaking at the Global Food Safety Forum’s event: Food Safety Training Summit on Monday, August 28, 2017 in Ho Chi Minh City, Vietnam.
Food Online: How does foreign supplier verification under FSMA allocate food safety responsibilities across the supply chain?
Dubois: I work mostly with laboratory analysts, managers, and regulators who are using laboratory data to ensure food is safe, so this is a question I get in every training workshop. Simply put, FSVP gives the responsibility to the importer who then must take the necessary steps to ensure the whole supply chain was under control.
This is difficult for laboratory analysts to grasp because they often think the results generated are the final answer to the question of safety. I guess it would be true if we could afford to test for every possible contaminant and with a very-high level of confidence (i.e. using a very-large sample). However, since we want to trade food at a cost consumers can afford, we have to be a little more strategic about how we ensure safety; and that is what FSMA is all about. It says safety has to be built into the products, not tested at the end.
This isn’t a new concept. The food industry has been using a variety of equivalents to HACCP principles since the 1970s. Testing is a verification tool, a series of numbers that give us confidence that production, transport, processing, and packaging were done under appropriate conditions and controls.
Food Online: What are the requirements of FSVP?
Dubois: I like to say it simply requires all players in the supply chain to tie up loose ends and gives the necessary assurances to the next player that they did everything they could to ensure the safety of the product. If all stakeholders do that, then the whole supply chain is under control.
It’s a two-way street from start to finish: stakeholders have to educate each other about the risks they know. For example, an importer of red pepper flakes for the U.S. market knows this spice is sprinkled on food once it is served; this is very different from the way it is used in Indian cuisine, where the pepper flakes are grilled in a pan then boiled in the stew. The grower of this pepper may have never sold anything to a market where they use products that way. Therefore, the grower would probably be unaware of the need for tighter controls on microbial contamination risks during irrigation, harvest, when the peppers are dried, packaged, etc.
Importers must tell their suppliers, probably an aggregator, who must tell their suppliers who are the farmers or farmers’ co-op. The importer has the responsibility of generating or gathering the paperwork demonstrating proper controls were put in place based on the risks associated with the food. Other players have to meet other requirements concerning the product, for example, preventive controls and qualified individuals, but that’s another topic for another day.
Food Online: Building off the previous question, what are some common misconceptions about foreign supplier verification? What can food makers do to help dispel them?
Dubois: In the circles I navigate, the most-common misconceptions are that the FDA requires export certificates and tests all imported products as they come in. Some people see a piece of paper as the golden ticket, as a regulatory authority taking responsibility and saying they checked and this food is safe.
Some countries have export certificate programs requiring a national government laboratory to perform selected tests and sign off on shipments before they can go, while others don't. This is a form of control put in place to safeguard the reputation of that country as a source for that food. In other words, safeguard their brand, but it is not all the controls needed to ensure the food is safe.
As countries invest in their food safety systems by adding tools — such as extension services, to teach farmers how to minimize risks, infrastructure, such as refrigerated warehouses, and better roads for efficient transport — they will be able to move to a situation where testing verifies the effectiveness of a controlled process. This is effectively what the FDA"s imported food testing is about. The FDA doesn't have the laboratory infrastructure or staff to test every shipment that comes in.
The relatively-new Operational and Administrative System for Import Support (OASIS) analyzes the information about the shipment. We can think of it as a risk assessor, looking at the level of risk associated with this food, the country of origin, the manufacturer, the importer, etc. If all looks good and the manufacturer and importer have a good track record, there is a pretty good chance this shipment will not be physically inspected because there is enough confidence the safety system in place worked. And, it has been working well for us since we seldom hear of foodborne outbreaks associated with imported foods, despite the fact we import the vast majority of some high-risk foods, such as seafood and fresh fruits, in the off season.
Food Online: What role is laboratory testing playing in foreign supplier verification? How does the domestic view differ from other large countries?
Dubois: FSVP lists periodically sampling and testing shipments as verification activities under a foreign supplier verification program. Of course, many importers are purely trading businesses and don't have laboratories, but laboratory testing is becoming more accessible because of the proliferation of third-party laboratories. They certainly help smaller industries have access to testing without needing to make the investment in infrastructure and staff themselves. In some countries, such as Malawi, government labs perform contract work for industry and traders, and the income from this service helps them support their regulatory testing functions. In other countries, such as Chile, private contract laboratories perform regulatory testing for the government. It is great that we are finally seeing creative ways to gain access to testing services.
Food Online: Are there certifications for laboratory testing? Why are they important and how do companies go about receiving them?
Dubois: The FDA was given the option to have its own certification scheme by FSMA, but the agency chose to rely on an internationally-recognized (and deployed) scheme offered by ISO. Food safety laboratories should seek ISO 17025 accreditation for the methods they use to demonstrate safety. The accreditation audits will look into all aspects of lab management to ensure proper traceability, training for the staff, documentation, and controls of the equipment. It is an expensive process and we have to keep in mind State labs in the U.S. did not seek this accreditation until very recently. The FDA invested some $50 million to help the labs reporting results for compliance achieve accreditation for selected methods. Therefore, this is a very-difficult endeavor in many developing countries because it is expensive, requires the production of a lot of documentation, and dedicated staff. So the cost is high, but it is agreed that the payoff is worth it since it is really what a laboratory needs to be able to present results that the trade partners will trust.
About Janie Dubois And JIFSAN
Janie Dubois manages the JIFSAN lab program at the University of Maryland. The Institute was established between the FDA and the University of Maryland (UM) in April 1996. The Institute is a jointly administered, multidisciplinary research, education, and outreach program.
The Institute fosters the missions of FDA and the University through the creation of partnerships to increase the quantity and quality of research, which will provide the basis for sound public health policy. It promotes food safety, human nutrition, and animal health and production through integrated research, education, and outreach programs. Opportunities exist for collaborative projects with Federal and state agencies, private industry, consumer and trade groups, and international organizations with mutual interests.