Long road to implementation seen for FDA's new FSMA rules on food imports, audits

“These new import authorities are going to change from a strategy of catching problems at the border to building prevention into the food supply chain,”​ said Margaret Hamburg, commissioner of the Food and Drug Administration.

Verification program, auditor accreditation​

The proposed new rules are the Foreign Supplier Verification Program (FSVP)​ and the Accreditation of Third Party Vendors​.  The rules are intended to help FDA deal effectively with food imports, which account now for 15% of the US food supply, and much more in certain categories such as fresh produce. Under FSVP, FDA would audit the way importers verify that their overseas partners are meeting food safety standards.  The third party auditor rule is intended to create a cadre of auditors, whether from private industry or foreign governmental agencies, whose work could be relied upon as if it were FDA's own.

While FDA would still conduct its own inspections of farms overseas, Mike Taylor, FDA's deputy commissioner for food, said the FSVP is a fundamental shift in the safety regime for imported food.

“The foreign supplier verification rule is the foundation for the new food safety system called for in the act,”​ Taylor said.  “It defines industry responsibility and accountability for managing their global supply chains.​

“FDA will be able to audit the importers plan and stop imports from coming in if we find the plans or implementation are inadequate,”​ he said in a conference call with reporters.

The rule pertaining to third party auditors is intended to help manage the new overseas inspection workload called for in the draft rule, Taylor said.

“We do see these accredited audits has having wider application in the food safety system. This reflects the common interest we all have in credible supply chain management,”​ he said.

Oversight is currently lacking​

The shift in focus is long overdue, Taylor said, and will help make for both a safer and more fair arena for imported food products.

 “The current system of import oversight is a number of decades old. It relies primarily on being physically able to examine less than 2% of food imports, and being able to chemically analyze even less than that. It relies on detecting and reacting to problems,” ​Taylor said.

“It’s a shift toward prevention and for industry being responsible in documenting what they have doing in the area in prevention. We want a level playing field so that all producers and their systems are operating at an appropriate level of prevention,”​ he said.

And Hamburg said the draft rules are not just new sticks for FDA, but include a carrot for industry, too.

“This will be able to identify the good actors and the bad actors and will put some incentives in place for compliance because companies will see their shipments move faster as they build up a track record of compliance,”​ she said.

Some provisions seen as nonstarters​

Food consultant and attorney Ben England, a principal of the firm FDA Imports, praised FDA for allowing a 120-day comment period right from the get-go, rather than starting with 90 days and then responding to calls for an extension.  But his first reading of the rules gave rise to a number of reservations, among them a provision that is meant to categorize risk by focusing less attention on products coming from countries that are deemed to have adequate internal governmental food safety controls.

“The problem is that the underlying language in the statute is not very good,” ​England told FoodNavigator-USA. “Congress asked FDA to require importers to do things that the trade would not normally tolerate because it would require knowledge they wouldn’t typically have.​

“There are some aspects that are nonstarters.  The idea of requiring an importer to determine whether a foreign government’s food regulatory system is comparable that of the United States is a nonstarter.  FDA can’t even do that,”​ he said.

For Nate Beaver, an attorney with the firm Foley & Lardner who has some large food companies as clients, there isn’t much in the FSVP draft rule that presents a huge red flag.

“For the largest companies, this is something that they are already doing. Most companies, this is something that is not really new to them. We don’t see this as an entirely new paradigm,” ​he said.

“My questions are from a timing and resource perspective.  That has some of the biggest question marks.  Given sequestration, given the limited budget, is FDA really ​going to have the resources to do what’s required in these rules?” ​

A pie-in-the-sky auditor?​

England also questioned the idea of whether a viable way can be found to accredit a third party auditor.  In other FDA regulated industries, dietary supplements for example, third party audits can help a company get a grip on regulatory issues such as GMP compliance.  But the findings of such an audit carry zero regulatory weight as far as FDA is concerned. 

“I think they put that rule out kicking and screaming because Congress told them to,” ​England said. “I think the idea of having accredited third party auditors is a little bit pie in the sky.  No such person exists, and that includes at the US Department of Commerce. The USDC already conducts foreign inspections of seafood facilities and FDA does not accept their inspections.​

“The implementation of this is unlikely to be very impressive,”​ he said.

Protracted implementation seen​

In the conference call, Taylor said that FDA plans to implement the rules over the next few years.  From England’s point of view, it could go on for a lot longer than that.  Whether FDA can pass judgement on a given importer's verification program implies that the agency has a handle on the risks inherent in a given type of food. And England said that is not always going to be the case.

“If you look at the guidance document that FDA has out for seafood HAACP, it’s 480 pages long and that’s just seafood.  And we know something about seafood,”​ he said.

“We probably know something about bakery and other products. But there are a lot of products coming into this country that FDA does not know much about.  The idea of FDA formulating a risk model for those is a bit of a pipe dream. So in that sense, the regs have to be vague, and it also means that implementation of this is still probably 10 years off,”​ England said.

“If someone has no plan, if they make no effort, then FDA can enforce that.  But that is probably going to be the limit of the enforcement probably for the first five years or so. ​If you look at the implementation of seafood HAACP, that started in 1995 or 1996. And in 1998, FDA was still writing warning letters that said, ‘You’ve got to have a HAACP plan,’ ” ​England said.