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FDA’s Foreign Supplier rule has an especially ambitious agenda

Of the seven rules the U.S. Food and Drug Administration (FDA) has issued under the 2011 Food Safety Modernization Act (FSMA), the one regarding Foreign Supplier Verification Programs (FSVP) is particularly ambitious. It attempts a number of things never done before with respect to the U.S. food safety system.

As FDA describes it, FSVP requires importers of food products into the U.S. which are destined for either humans or animals to take responsibility for the safety of the food they import by performing certain risk-based activities. The goal is to make sure that the imported food has been “produced in a manner that provides the same level of public health protection as that required of domestic food processors and produce farms and is not adulterated or misbranded with respect to allergen labeling.”

It’s hard to miss all the imported food items on grocery store shelves these days. According to FDA, the U.S. trades in food products with more than 200 countries and territories and imports food products through more than 300 U.S. ports. In addition, the agency states that food imports to the U.S. more than doubled from 2003-2013.

“This active international trade has allowed U.S. consumers to enjoy a wide variety of foods year-round, and U.S. consumers expect that all foods sold in U.S. markets will be safe for themselves and their families,” FDA notes.

What does the FSVP rule require?

FDA inspectors checking fish

FDA inspectors checking a shipment of imported fish.

Importers who come under the authority of the new rule will need to conduct hazard analyses for the food they produce and also for food products supplied to them by others. Specifically, they will need to:

  1. Anticipate known or foreseeable hazards associated with particular types of food.
  2. Evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance. The particular food risks, as well as the foreign supplier’s performance, must be reevaluated every three years, or when new information comes to light.
  3. Use the data to approve foreign suppliers and design appropriate methods of supplier verification. The importer is free to tailor the verification processes to the unique characteristics of a food or a supplier’s situation.
  4. Conduct corrective actions to maintain the integrity of their supply chain.

For food items entirely manufactured outside the U.S., the rule requires the importer of the finished product to make sure that appropriate safety controls are in place. If the food items are made in this country, the domestic facility must do so.

As noted by attorney Kathy Hardee in a December 2015 article for Food Safety magazine, the FSVP rule first looks to the importer, which is the U.S. owner or consignee of a food offered for import into the U.S.

“If the importer is a food manufacturer otherwise subject to the preventive controls rules, no FSVP program is necessary because the hazard is identified and managed under their preventive controls processes,” Hardee wrote. “If the importer is not a U.S. manufacturer subject to the preventive controls rules and does not meet one of the other enumerated exceptions, the importer must create and implement an FSVP.

CBP Officers search products coming into the U.S. as Cargo.

U.S. Customs and Border Protection officers search products coming into the U.S. as cargo.

“An FSVP requires the importer to vouch for the foreign supplier of an article of food. The foreign supplier is generally the foreign entity that manufacturers and processes the food being exported to the United States. If a foreign food passes through an intermediary packer, holder or re-labeler, the original manufacturer is still deemed to be the foreign supplier,” she stated.

FDA’s outreach efforts

While FDA is working on guidance for all food importers on how to comply with the FSVP rule, the agency has reached out to affected parties by previously soliciting public comments (now closed) and will be holding three public meetings next month to help ease the way.

The first meeting will be June 7 in Costa Mesa, CA, the second will be June 15 in Rutherford, NJ, and the third will be June 21 in Detroit, MI.

According to Liz Freedman, a health communications specialist with FDA, these meetings have two major goals:

“The purpose of the regional outreach public meetings is to continue the dialogue with the importer community on FSMA and elicit ideas that will help to inform the FDA and our stakeholders on how to continue to work together to endure the industry successfully complies with FSVP and other FSMA regulations.”

Charles Breen plans to attend these meetings in order to better advise his clients on complying with the FSVP. The food safety consultant, who retired in 2013 as FDA’s district director in Seattle, said he has been conducting assessments with food importers about the rule.

“What I hear is, ‘What does FDA expect?'” he told Food Safety News. “The rule provides a lot of different ways for suppliers to verify, and it’s baffling for those who do not read government documents on a regular basis.”

Timelines for compliance

TraceGains sidebar on FSVPCommon sources of confusion are the effective compliance dates for the rule and who will actually need to comply with it and to what degree.

FDA set up one entire web page to outline the effective compliance dates. It shows that the first one is May 30, 2017, for any FSVP importer whose foreign supplier is not subject to FDA’s FSMA PC or produce safety rules. (“PC” refers to Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, while “produce safety rules” means Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”)

At the outside, certain “very small businesses” could have until July 27, 2020, to comply with provisions of the FSVP rule. FDA defines that category of importer the same way as in the agency’s preventive controls rule, Freedman noted, or “a sales ceiling of $1 million for human food and $2.5 million for animal food.”

“Modified FSVP requirements are established for very small importers and importers of food from certain small foreign suppliers. (An example of these modified requirements is that certain importers would not have to conduct hazard analyses. They must verify their foreign supplier by obtaining written assurance of compliance from the supplier.),” she stated in an email to Food Safety News.

Additionally, importers of food from certain “small foreign suppliers” are subject to modified FSVP requirements, Freedman noted. These small suppliers include:

  • Facilities subject to modified requirements under the preventive controls rules because they are qualified facilities,
  • Farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption, and,
  • Shell egg producers with fewer than 3,000 laying hens.

“There are modified FSVP requirements for certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the United States’ system,” she pointed out.

The only countries meeting the criteria to date are New Zealand and Canada, Breen said.

Canada was officially recognized as having a food safety system sufficient to comply with requirements. The first was New Zealand,” he said, adding, “The rumor I’ve heard is that Australia and then the European community are next in line.”

Breen called the idea of the entire European community being recognized as equivalent “a challenge” because food safety systems in Spain or Greece may be different than, for example, those in Germany or France.

When a foreign country applies to the U.S. for food safety equivalency status, FDA uses what’s called an ICAT (International Comparability Assessment Tool) to evaluate the application.

Exemptions from the FSVP rule

FDA official checks imported zucchini.

A federal official inspects imported zucchini.

Freedman stated that the following foods are exempt from the FSVP rule:

  • Fish and Fishery Products (in compliance with FDA’s seafood HACCP regulations) or certain ingredients used in such products in compliance with the seafood HACCP regulations;
  • Juice (in compliance with FDA’s juice HACCP regulations) or certain ingredients used in juice products in compliance with the juice HACCP regulations;
  • Food for research or evaluation;
  • Certain alcoholic beverages or certain ingredients used in such beverages;
  • Certain meat, poultry, and egg products regulated by the USDA;
  • Food imported for personal consumption;
  • Food that is transshipped [transferred from a ship or other form of transport to another form of transport];
  • Food that is imported for processing and export, and,
  • U.S. food that is exported and returned without further manufacturing/processing in a foreign country.

More information about who and what is subject to the FSVP rule can be found here.

The question of enforcement

Due to its ambitious agenda, it’s assumed that the FSVP rule will require a strong enforcement presence. However, FDA has limited resources for that function, particularly overseas, and can only do so much with its current budget and staffing levels.

Asked how the agency plans to enforce the rule, Freedman responded this way:

“First, we plan to provide educational materials to industry (e.g. public meetings, webpages). After the compliance dates, the FDA will begin reviewing the records of importers to determine compliance with the FSVP regulation. If the FDA determines, based on the review, that the importer is not in compliance with the applicable FSVP requirements, the agency may pursue regulatory action (e.g., Warning Letter, placing the importer on Import Alert).”

Breen said FDA knows that the agency will need to work with staff on state, tribal and other levels to help with the enforcement piece of the puzzle. That’s why FDA is contracting with states (37 at last count) to get this done, he said.

Breen also said that he expects FDA to use a “risk-based approach” to enforcing the FSVP rule, meaning that it will “focus its traditional activities to better target firms and foods that prevent the highest potential risk,” as the agency puts it.

“I don’t think FDA will be enforcing for some time,” Breen said. “Paraphrasing from [FDA Deputy Commissioner for Foods and Veterinary Medicine] Mike Taylor, it will more be doing education before enforcement. Even though he’s leaving next month, I think that FDA knows that it will need to be educating for some time.” (Taylor has announced that he plans to depart FDA on June 1.)

fdashrimpinspection-iphone

Imported shrimp gets a close look from a FDA inspector.

According to the agency’s Office of Regulatory Affairs, FDA has approximately 2,000 investigators to handle an increasing number of imports, and there is ongoing concern about how they will be able to complete the additional foreign inspections called for under the FSVP rule.

“The question of what is enough has long been an issue,” Breen said. “I do know that one aspect of FSMA is that FDA has told Congress that it does not have the resources to do foreign inspections. By next year, there are supposed to be 9,000 foreign inspections. The agency has told Congress it will able to do between 1,200-1,300 of those inspections without additional resources.”

Like the other six FSMA rules FDA is responsible for implementing, the Foreign Supplier Verification Programs rule is ambitious, challenging and maybe even a bit scary for those who face changing the way they do business in order to meet its requirements.

However, Breen indicated that taking a longer and more collective view of these new regulations could be the best strategy, and he had the following advice for those who will need to comply with the FSVP rule:

“Everybody who is going to be subject to this rule should not forget to breathe,” he said. “FDA is going to make sure that this rule works. This is my personal opinion that the success of FSMA in general is as crucial to FDA as it is to the food industry. This has to work for both.”

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