New FDA Food Safety Rules Could Close Doors for Small Businesses and Developing Countries

(FDA published its proposed rules on produce safety and hazard analysis and risk-based preventative controls (HARPC) on Jan. 16. The produce safety rule would apply to foreign and domestic growers, harvesters, packers, and holders of fresh fruits and vegetables, while the preventative controls rule would apply to foreign and domestic food facilities that manufacture, process, or pack human food. Another component of the Food Safety Modernization Act, the Foreign Supplier Verification Program, would require food importers to verify their foreign suppliers’ compliance with these two food safety regulations. The FSVP proposal has yet to be published, and is currently awaiting Office of Management and Budget approval. See ITT’s Online Archives 13010429 for summary of the preventative controls rule, and 13010805 for summary of the produce safety rule.)

Potentially Onerous Requirements Could Push Out Small Businesses

The applicability of the new food safety requirements to foreign farms and facilities, combined with importer verification, means exporters “are going to have to be on the ball in order to ensure their importing counterpart that they know what they’re doing, and that they are compliant,” said Sara Zborovski of Gilbert’s, a Canadian law firm. “I think we’re going to potentially see a lot of smaller companies getting squeezed out, because the requirements will be potentially onerous.”

Zborovski is particularly concerned about the preventative controls proposal’s requirement for food facilities to have a “qualified individual” to prepare and oversee food safety plans. The proposal defines a qualified individual as a person who has completed specialized training in developing and implementing risk-based preventative controls, or is otherwise qualified through job experience, said Zborovski. The training must be at least equivalent to an upcoming FDA-approved curriculum, and must be documented.

But at this point, industry is still in the dark on exact requirements for the position. It isn’t clear whether the qualified individual could be a current employee sent for training or a new hire, or how expensive the position will be to fill, Zborovski said. Questions also remain about whether there will be enough qualified individuals to satisfy demand. “I think there’s a fair bit of concern that this is going to be an onerous requirement," she said.

The entire process of preventative controls will be difficult and could require outside assistance, said Ricardo Carvajal of Hyman, Phelps, & McNamara. “I think anybody can put together something on paper,” he said. “But as we’ve seen in the seafood context, doing It right and doing it in a way that meets FDA’s criteria is a whole other issue,” said Carvajal, referring to implementation of seafood hazard analysis and critical control point requirements. Conducting the hazard analysis, applying the results to the development of preventative controls, and creating a plan with the right kind of monitoring and verification is not easy, he said. “Maybe for some foods and some types of foods it’s not going to be particularly challenging, but on the whole it’s not a really simple exercise, and I think there are going to be any number of businesses that are going to have a hard time with it.”

In the seafood case, some countries have entities on import alert for violations of seafood HACCP requirements, Carvajal said. “I know from my experience that those businesses have had to go out and retain consultants, because they didn’t have the sophistication or understanding.”

“I think if you are a small mom-and-pop shop and you want to export to the U.S., you’re going to have to make some investments to make sure that you can satisfy your importing counterpart that you are compliant with FSMA,” said Zborovski. As the food industry as a whole gets more regulated and governments tighten food safety standards, the smallest operations are going to get squeezed out. “I don’t know if that’s a good thing or a bad thing -- if you’re looking from a pure food safety perspective, I’m sure people would argue that’s a good thing. I’m sure from a commercial and competition perspective others would argue it’s not a good thing,” she said.

Impact Worse for Less Developed Country Food Facilities and Farms

Meanwhile, the ability of foreign suppliers to comply with the rules may vary with their countries’ level of development. “I think FDA and industry understand that there is a pretty broad diversity out there in terms of the regulatory capabilities in different countries, and the resource base in different countries,” Carvajal said. “And those things are typically linked.” Developing economies with less developed regulatory infrastructure also tend to be the countries where there are smaller producers who are less sophisticated, particularly when it comes to making more challenging products from a food processing standpoint, he said. “I don’t think FDA is going to spend as much time worrying about products coming out of advanced economies in the European Union as they’re going to spend worrying about products coming from some of the more underdeveloped countries in Southeast Asia, or in Latin America.”

An already sophisticated food safety system in the EU will make it easier for European companies to comply, said Philippe Binard, general delegate of Freshfel Europe, a European produce industry group. “Given the high level of food safety regulations already in place in the EU, the compliance process will be facilitated for EU exporters,” he said. Several monitoring plans are already in place, including the EU General Food Law and other quality, food safety, and labeling legislation, he said. “EU exporters will therefore be in a good position to provide to their U.S. import agents the necessary certifications and monitoring plans confirming that the products were grown under the same level of health protection as that required by … the new Food Safety Modernization Act.” Binard said European produce exporters are more worried about “protectionist and excessive plant health barriers” blocking imports of a wide range of EU fresh produce to the U.S., and noted a lack of progress in negotiations.

Canada passed its Safe Food for Canadians Act in November, which shares many themes with FSMA, Zborovski said. It places an increased burden on importers, and prioritizes the prevention of recalls rather than reaction to food safety problems. There is also talk of preventative controls and more recordkeeping requirements, she said, although the law leaves many details to be decided by Canadian regulators. “I think that we can hope for some harmonization,” Zborovski said. “It would be nice to only comply with one set of rules, or at least have a system in place that would work for both countries, because we do pass things between our borders so regularly.”

In developing countries, however, with fewer resources and less-developed food safety systems, compliance with the preventative controls and produce safety rules will be more difficult. Farms and food facilities in some less developed countries are not going to be able to afford a consultant with the level of expertise that a company based in the EU would be able to afford, said Carvajal. While FDA has set up foreign offices to build capacity in foreign countries, coverage is far from widespread. For example, in all of Latin America the FDA only has offices in Mexico City, San Jose, Costa Rica, and Santiago, Chile, he said.

“The further out you get from the very developed, very food safety-focused countries … I think it will be harder and harder to ensure that you’re getting the same standard of food from a safety perspective,” said Zborovski. And with the onus on them, importers may be more likely to source from countries with similar food safety systems. “Mexico and Brazil aren’t necessarily that far off,” she said. “They’ve established relationships, and they know about food safety. There’s no question. But as you go further and further in the world, I wonder if doors may become more closed.”