The challenge for the FDA when designing the program, however, will be getting the incentives just right, says Cary Coglianese, director of the Penn Program on Regulation at the University of Pennsylvania. “A problem with any voluntary program,” he explains, “is that there exists a tradeoff between maximizing membership and demanding members do all that much.”
It’s a problem the FDA is hard at work trying to solve. “One of the things we’re working toward is ‘What are benefits to the industry? ‘What are the ramifications if anything goes wrong?’ ‘How is it going to benefit the agency?’” says Veneziano. “Obviously there has to be a two-way street on a program that’s going to benefit both us and them.”
And considering the agency’s threadbare coffers, the FDA has an incentive to ensure VQIP’s attractiveness to importers. “[The FDA] wants to push people into that…potentially to generate revenues,” Acheson says. The revenues raised can then be allocated to identify those nonmembers who import high-risk food or do business with high-risk foreign suppliers.
FDA’s new import safety strategy is what some academics call metaregulation. This regulatory strategy means governments promote and supervise self-regulation, but pepper it with enough coercion to invite cooperation. This is precisely what FSMA does for U.S. importers, says Coglianese.
FSMA basically directs the FDA “to facilitate and oversee, through various regulatory and nonregulatory efforts, the ‘regulatory’ work of others, be they importers, third-party auditors, [or] foreign regulators,” Coglianese tells Security Management. Kennedy agrees, stating that it’s more efficient for importers to push safety standards down through their own supply chains than for the government to do it. McCormick’s Ramsey calls this the “20 Elephants Theory: When you take the 20 biggest companies in the country, and they decide they want something, then everyone that supplies them has to fall in line with that.”