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From: Food Quality & Safety magazine, October/November 2013

Will FSVP Shed Light on Food Safety or Keep it in the Dark?

by Shawn Stevens

Will FSVP Shed Light on Food Safety or Keep it in the Dark?

It’s the things we can’t see that we fear most. In the food industry, our fear of invisible pathogens is really no different than the fear of the basement we had as a child (or in my case, as an adult). We were terrified of going down the basement stairs because we couldn’t easily see and thus not easily verify whether there were any ugly creatures waiting in the shadows for the opportunity to pounce. Human instinct has made us fearful of such places because it is difficult to protect against threats we simply cannot see. Fortunately, the solution, in most cases, was to quickly “turn on the lights.”

Fears of the unknown have driven substantial change in the food industry. In the U.S., industry responded in a similar fashion to the threat of invisible microorganisms by “turning on more lights.” More food companies are testing more ingredients, equipment, and finished products—and now more harmful pathogens are being found.

Similar concerns exist with respect to the overall safety of foreign food product imports. If we stand on the beaches of California, we cannot see what’s happening on the opposite shore. The inability to see clearly (or at all) what is occurring with respect to the growing, processing, and export of incoming foreign foods causes both industry and government to become increasingly fearful of the unknown.

There are political reasons as well. More than 15 percent of the food consumed in the U.S. each year is imported from foreign shores. And this number is growing larger. Increasingly, more consumers are beginning to question where their food is coming from and what is being done by government and industry to ensure its safety. This is especially true when foreign food products have been involved in an increasing number of food safety scandals. Headlines have included stories about melamine in pet food, mercury in baby formula, and the misbranding of meat.

So what is the solution? Here too, rather than urging companies to stop buying foods from foreign countries, FDA has proposed instead to “turn on a few more lights.” Moving forward, FDA will require all food companies in the U.S. who import foreign food products to take steps designed to ensure the food they are importing is as safe as it can be.

Well, maybe. No one expected that when the FDA published its proposed Foreign Supplier Verification Program rules, FDA would actually publish two sets of rules and invite key stake holders to, in effect, “vote” on which of the two they liked best.

On the one hand, the FDA’s approach might be viewed as commendable for letting consumers, industry, and politics guide the debate; but on the other hand, the agency appears to be sidestepping its responsibility of issuing regulations which, in its expert judgment, are best suited to keep industry strong and consumers safe. With that said, whether motivated by a fear of being perceived by suppliers, industry, and consumers as doing “too little” or being perceived as doing “too much,” FDA seems to be hedging its bets by proposing two alternatives.

Two Options

For simplicity sake, let’s call the two sets of proposed rules “Option 1” and “Option 2.” In its most simple form, Option 1 creates stringent auditing requirements on higher-risk foods and less stringent requirements on low-risk foods. Option 2 simply creates less stringent requirements on all foods, regardless of risk.

Under Option 1, if a food product is subject to a hazard that is reasonably likely to occur and there is a reasonable probability that exposure to the hazard will cause serious adverse health consequences or death, then the importer must ensure the foreign supplier is being audited at least once annually by a qualified individual. A qualified individual is a person with the necessary education, training, and experience to conduct a food safety audit which will ensure the foreign supplier is complying with the regulations.

If, however, a food product under Option 1 is subject to a hazard for which there is not a reasonable probability that exposure will cause adverse health consequences or death, the requirements are far less stringent. In these circumstances, the importer will have the ability to choose for itself which verification procedure from a list proposed by FDA it will use. These less stringent verification procedures include periodic onsite auditing; periodic lot-by-lot sampling and testing of the food; periodic review of the foreign supplier’s food safety records; and any other procedures which, in the discretion of the importer, are deemed “appropriate.”

Under Option 2, regardless of the level of risk associated with a food product, an importer will be able to establish compliance by merely selecting one of the less stringent verification procedures outlined above. Thus, the real difference between Option 1 and Option 2 is that, with respect to food products that carry a reasonable likelihood of causing adverse health consequences or death, under Option 2 there is no auditing requirement. Instead, importers simply could choose to periodically review the supplier’s food safety records, to periodically test the supplier’s products, or to follow any other verification procedures the importer deems “appropriate.”

Many foreign food product suppliers who remain unable to pass a simple audit will continue to exist unregulated and unsupervised in the shadows.

Life or Death Decisions?

In light of the differences between options, how could choosing one or the other really be a matter of life or death? The answer really depends upon whether the question is viewed through the lenses of foreign product suppliers, importers, or consumers.

From the perspective of foreign food product suppliers, Option 2 may be interpreted as the only real option. Under Option 2, importers could demonstrate compliance, regardless of the capabilities or qualifications of the foreign supplier, by “periodically” testing incoming products or selecting one of the other less stringent procedures (or, I guess, by simply making up one of its own). If Option 1 were selected, however, a large number of existing foreign food product suppliers would likely be forced out of business.

This is because many foreign suppliers, in order to export to the U.S., would be forced to pass a physical audit demanding them to demonstrate actual compliance with each of the requirements of the Food Safety Modernization Act (FSMA), including the requirement that they develop and implement a science-based written preventative control program. Foreign suppliers would also be required, in order to pass that audit, to comply in other respects as well, demonstrating they have adequate prerequisite programs, equipment, and facilities. Because many foreign suppliers would be unable to satisfy the proposed auditing requirements, they would also be unable to export foods to the U.S. Thus, from the perspective of many foreign food product suppliers, the choices being proposed by FDA raise literal questions of life and death.

From the standpoint of the importer, the answer is less clear. On the one hand, the audit requirements should be welcome from the standpoint of sophisticated companies. Requiring audits of all foreign suppliers of high risk foods will enhance incentives for foreign suppliers to upgrade their food safety systems, will ensure the increased safety of all high-risk foods, will promote the application of uniform standards applicable to all foreign suppliers, and will level the competitive playing field for all importers. On the other hand, the cost of foreign food product imports will likely increase (at least in the short-term) as companies work to achieve compliance, and importers will likely be burdened with increased regulatory costs as they themselves work to ensure their foreign suppliers are FSMA compliant and being properly audited by qualified individuals. Bottom line is everyone wins, but foreign imports become a bit more costly.

From the standpoint of consumers, Option 1 is without question the only option. As noted above, we often fear what we cannot see. Option 1, for all practical purposes, is the only option that actually “turns on the lights” with respect to foreign food products. If enacted, each foreign supplier of high risk foods will be required to have an audit. In order to pass that audit, the foreign food product supplier will be required to establish it satisfies, with only a few exceptions, each of the more stringent requirements of FSMA. Unless this option is selected for enforcement by FDA, importers will be able to select any one of the less stringent verification procedures requiring only “periodic” checks of records or testing, and many foreign food product suppliers who remain unable to pass a simple audit will continue to exist unregulated and unsupervised in the shadows. From the standpoint of the consumer, choosing the wrong path could have catastrophic consequences.

So, if you join me in the basement to escape for a moment the politics of global food safety and foreign trade (which in this business is nearly impossible to do), I offer the following advice: If the real goal is to improve the safety of foreign food product imports, then Option 1 is the best choice. Option 1 will quickly and brightly illuminate noncompliant suppliers, will improve the quality and safety of all imported foods, and, in doing so, will save lives.

FDA has given stakeholders until November 26, 2013 to comment on the two competing rules. I urge you to comment on the option you like best, but warn that the choice you make could, quite literally, mean the difference between someone’s life and death.


Stevens, an attorney at Gass Weber Mullins LLC in Milwaukee, Wis., counsels food industry clients nationally on food safety regulatory and liability issues. He can be reached at stevens@gasswebermullins.com.

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