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Experts worry importers not ready for next FSVP deadline this month

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While the March 19 compliance deadline for Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) is quickly approaching, results from FDA’s first FSVP-related inspections are raising questions about how prepared importers are for the new requirements.

Since FDA started inspecting importers for the new FSVP mandates last year, the agency has already issued more than 100 compliance-related citations.

And in many of those cases importers lacked not just understanding of the new mandates, but also of the consequences related to non-compliance, says Charles Breen, a former FDA official who advises on FSMA at EAS Consulting.

With many more companies having to come into compliance with the second wave of the new FSVP mandates in less than two weeks, experts like Breen are warning companies that they could be facing significant problems if they don’t step up and make an effort to prepare for the complexities of this new mandate.

“Being unable to import is a pretty severe consequence,” Breen told IEG Policy Wednesday (March 7).

“If they are making a good-faith effort to come into compliance, they will be fine. But if they have not made a good-faith effort to come into compliance … FDA will come knocking on the door,” Breen added. “If I were an importer and had not made good faith effort to come into compliance by now, I would do that as soon as possible.”

Depending on the severity of violations, a non-FSVP compliant company could face anything from a warning letter, to being placed on import alert and even suspension of facility registration.  

In the most extreme cases FDA can even stop an importer from importing food, for which there is no evidence for compliance, Breen noted.

It remains unclear what portion of “small” importers will be ready to meet the new mandates by the March deadline. But knowing that the upcoming deadline will affect a significantly larger number of importers than it did last year, and that FDA is planning to ramp up FSVP inspections – from about 300 last year to thousands over the coming months – some experts are already predicting a spike in upcoming FSVP violations.

“I do think that number’s going to go up next year,” said John Johnson, a senior associate attorney at FDAImports.com.

“This is a brand new regulatory regime on a community,” Johnson explained. “You are taking food importers, which are really brokers and their specialty is logistics and supplier selection and customs. And now they are being asked to take in a food safety model.”

A new regulatory framework

The Foreign Supplier Verification Programs (FSVPs) for Importers of Food for Humans and Animals Rule is one of the seven foundational rules issued under FSMA with the goal of making importers accountable for verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards.

The rule was developed to ensure food importers verify they are significantly minimizing or preventing risks and producing food in a manner that provides the same level of public health protection, as required under the other new FSMA regulations on preventive controls and produce safety. The verification activities could include annual on-site audits of a supplier’s facility, sampling and testing of food, or reviews of the supplier’s relevant food safety records.

Upon implementation, importers of food are required to follow specific steps before importing food products into the U.S.:

  • develop, maintain and follow an FSVP for each food brought into the United States, as well as for the foreign supplier of that food;
  • determine known or reasonably foreseeable hazards with each food, based on experience, illness data, scientific reports and other information;
  • determine and conduct supplier verification activities tailored to the unique food risks and supplier characteristics to ensure suppliers are producing food consistent with U.S. requirements; and
  • conduct corrective actions if they determine that a foreign supplier has used inappropriate processes and procedures or produces food that is adulterated or misbranded with respect to allergen labeling.

The FSVP rule is being implemented in stages, depending on the size of the foreign supplier, the nature of the importer, and whether the foreign supplier must meet the requirements of the final rules for Preventive Controls rules for human and animal foods and the Produce Safety rule.

The upcoming March deadline applies to a range of importers, namely:

  • importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF);
  • importers of animal food whose Large Business Foreign Supplier is subject to the Preventive Controls (PC) requirements in Preventive Controls rule for Animal Foods (PCAF), but not to current Good Manufacturing Practices (CGMP) requirements, and
  • importers of animal food whose Small Business Foreign Supplier is subject to PCAF CGMP requirements 

FSVP challenges

While the first FSVP mandates have been in effect for the larger food processing suppliers since May 30, 2017, experts believe that the upcoming March 19 deadline will have a much wider impact on importers.

That is because the upcoming deadline applies to food producers that are considered “small,” which FDA defines as food facilities with less than 500 full-time equivalent (FTE) staff positions. And in reality, most food facilities fit into that definition, Johnson said.

And over the past year, it has become clear that meeting the FSVP requirements is not a simple task, Johnson noted.

 

“If they are making a good-faith effort to come into compliance, they will be fine. But if they have not made a good-faith effort to come into compliance … FDA will come knocking on the door.” - Charles Breen, EAS Consulting

 

Completing the hazard analysis required by the new rule, for example, has been one challenging area.  

“What you are being asked to do is look at a food product and the manufacturing process and think about all of the hazards and which ones are the ones that would require a control,” he said. “There are people who get PhDs in that type of work. FDA is working to simplify it through guidances and they did it with seafood and they are trying to with all the other food products, but it’s still challenging.”

And in some food product areas, trade groups have also tried assisting industry by providing hazard analysis for their specific types of products. Coffee trade groups for instance, have issued a hazard analysis for imported green coffee beans, Johnson said.

“But these are not things that are familiar to many importers,” he said. “Because many importers are relatively small companies.”

Importers have also been having hard time realizing what the requirements are for their Global Food Safety Initiative inspection reports.

“The rule says you need to actually read it and understand it. Did they inspect the right thing? Were there any issues that came up you should be worried about?” he said, noting that in some cases importers receive the report and simply put it aside, without studying it any further.

“Having that and not understanding it is not enough,” he said.

Maintaining the documents for the new rule has also been a challenge for importers, who in some cases don’t understand that under FSMA, not having a written record is a violation, he noted.

And days before the new deadline, import companies appear to be all over the map in terms of their understanding of the new FSVP requirements, Johnson said.

“There are those who are prepared and understand the rule, they are ready to go,” Johnson said. “There are those who know the rule is there, but aren’t really certain what to do. There are also those who are going to wait till FDA starts beating people up, till then they are just going to sit around. And then, there are those who have no clue what’s going on. We don’t really know the exact numbers, but we do know that there are a number of firms in all four categories.”

There is still time to come into compliance 

The good news however, is that FDA is also new to implementing this rule, and as in other FSMA areas, the agency has indicated that in the first years of implementation it plans to educate, while regulating.    

What that means for importers, according to both Johnson and Breen, is that despite the looming deadline, companies still have time to prepare for compliance or seek assistance when the complex FSVP framework becomes a challenge.

According to Breen, one of the first steps for businesses should be determining whether their company needs to comply with FSVP, what specific FSVP mandates they need to apply and ensuring that their foreign food suppliers are aware that in order to comply fully with FSVP, they must first be compliant with the FSMA Preventive Controls regulations for both human food and animal foods.

Companies also have to consider a number of FSVP exemptions, Breen noted in a blog post he penned on the subject on Feb. 28.

For instance, while foods imported Canada, New Zealand and Australia are still subject to FSVP requirements, companies that import foods from these countries “may document FSVP compliance by relying on inspections by officially recognized food safety inspections in those countries,” Breen noted.

“Their food safety systems are deemed to be comparable to that of FDA. Companies must clarify that imported food is within the scope of that official recognition or equivalency determination,” Breen noted.

Because the details of this FDA recognition are still being worked out, food companies from Canada, New Zealand and Australia should consult with their US customs agents or a consultant company to ensure they have the latest information on this moving target, Breen stressed.

There are some tools that FDA has developed to assist businesses with that determination. Importers for instance, can use an FDA flow-chart, outlining FSVP exceptions, as well as cases when they might need to meet modified FSVP mandates; and cases when businesses must meet the full FSVP mandate.   

Because the size of a business is also a factor that determines when companies need to comply, importers can also use another tool that FDA developed to help companies calculate inflation and determine if their income places them into the definition for “very small business,” Breen said.   

“The size of a business is a factor in whether companies need to comply, as is the case with those that meet the definition of a ‘very small businesses’ (i.e., earned less than $1 million per year on average in the preceding three calendar years, adjusted for inflation from 2011, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale; or in the case of Animal Food – $2.5 million per year for three years in sales of animal food, combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee)),” Breen wrote in his post.

And while the path to FSVP compliance may not always be easy to understand, companies may also use consultants to help them navigate the new regulatory framework, Breen noted.

“Whether with the help of EAS or working independently with your own internal staff, make sure your FSVP compliance documentation is in good working order,” Breen urged.

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