New Food Safety Regulatory Enforcement is Here

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By Ben England
| Legal News

Fruit Sailboat

Increased reporting of food borne illnesses and immediate access to news through virtually instant media have allowed American consumers to learn about outbreaks and food recalls much more quickly than they did a mere 20 years ago. In 2011, this increased visibility brought a need for Congress to rework the Food and Drug Administration’s food safety regime with the Food Safety Modernization Act (FSMA) of 2011. Although the statutory changes imposed by the FSMA were developed with surprising speed (and none-too-few procedural oddities), May 30, 2017 represents the first time the food industry must confront a truly impactful FSMA implementation date. 

As background, the FSMA substantially enlarged FDA’s power to regulate the safety procedures for producing, manufacturing, packaging, storing, and transporting food. FSMA also provided FDA with new powers to regulate food imports by increasing FDA's ability to inspect foreign and domestic facilities and the agency’s enforcement powers (including broadening FDA's administrative detention powers and FDA's ability to require production of information) and granting FDA the authority to issue mandatory recalls in the case of serious food safety risks.

On May 30, FDA will begin to enforce the Foreign Supplier Verification Program (FSVP) under FSMA. Pursuant to FSVP, FDA will require many food importers to verify that their foreign suppliers are in compliance with relevant food safety standards and that the food they import is not adulterated. 

All of this seems reasonable enough. But what does this mean for food importers? And what about companies purchasing imported food from U.S. sellers?

What is FSVP?

FDA’s Foreign Supplier Verification Program (FSVP) rule arises out of FSMA and is intended to promote the safety and compliance of imported food from foreign suppliers. It requires non-exempt importers to establish documented procedures that evaluate the hazards and risks associated with each foreign supplier and each imported food product. In essence, it is a documented check-and-balance system that puts the responsibility of protecting Americans from unsafe foreign food on the shoulders of the importer. FDA has the authority to evaluate food importers’ FSVP to determine if they are adequate to achieve the goal of food safety. FDA also can refuse admission to imported food received by importers with an inadequate FSVP system.

What needs to be included in this program?

  • A Food Safety Hazard Analysis
  • A Food Safety Plan
  • An array of verification activities designed to demonstrate foreign food suppliers are complying with FDA’s food safety regulations
  • Documentation that they are relying on a qualified individual with adequate training and/or experience capable of performing and monitoring these steps
  • A corrective action plan
  • A Good Manufacturing Practice System to govern non-safety related food adulteration issues (e.g., filth, decomposition, etc.)

Who is the food “importer”?

“Importer” in this context is different than an Importer of Record, which is a term with legal significance in Customs law. FDA provides that an “importer” is “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer.” [21 C.F.R. § 1.500] It turns out that neither “consignee” nor “owner” have common meanings in FDA’s world. In this instance, however, FDA has defined “U.S. owners or consignee” to represent “the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food.”

Therefore the importer, for FDA’s FSVP purposes, might not be the importer for Customs purposes. FDA refers to this company or individual as the “FSVP Importer.”

So the importer is now in charge of food safety?

That is the idea. FSVP shifts certain burdens of ensuring the safety of imported food from FDA to the importers themselves. Importers must identify all potential hazards related to each of their foreign suppliers’ food products. Food safety hazards may be physical, biological, chemical, or radiological; examples include harmful bacteria, illegal pesticide residues, harmful chemicals, radioactive particles, unapproved additives, and glass or metal – and all must be considered – for every food, from every supplier. Importers must conduct risk analysis of each food product and identify, evaluate and document who controls potential hazards.

The importer also must evaluate the foreign supplier’s food safety history and compliance with FDA food regulations. Those performing the required analyses must have expertise about the imported food as well as FDA regulations; including regulations on food adulteration and misbranding, good manufacturing practices (GMPs), preventative controls, and produce safety requirements.

Overall, FSVP and related regulations under FSMA give FDA new tools to monitor food safety through the entire supply chain for both domestic and foreign food companies. Most notably, the Preventive Control rules (aka Hazard Analysis and Risk-Based Preventive Controls or HARPC) require manufacturing and processing facilities identify hazards and control those hazards for raw materials, packaging, dyes, etc. Burdens fall to most parties in the supply chain, including packing, storing, and distribution. Risk-based controls must be developed for each “critical control point” where food safety hazards may exist.

What Happens on May 30, 2017… and what if I’m not ready?

Many in the food industry have begun to worry that on May 31, 2017 FDA will begin issuing import refusals against all food shipments with an importer that is out of compliance with the FSVP rule. That is not going to happen.

FDA has publicly stated that it does not intend to verify compliance with the FSVP rule in conjunction with an individual shipment of imported food. Nor could it do so. FDA does not intend to hold an imported food shipment while it reviews the importer’s FSVP system. Rather, FDA will use physical inspections of the importer’s facility to determine compliance with the FSVP rule. 

We expect FDA to follow its traditional administrative practices related to these inspections. Beginning May 31, 2017, FDA may indeed conduct a few FSVP inspections of food importers – most likely larger ones which are likely to have well-established food safety systems. But if FDA has had any questions about a food importer’s ability to ensure its imported food is safe in the past, that importer could be targeted as well. If FDA observes a non-significant health/safety issue during an FSVP inspection, the Agency will likely provide the importer an opportunity to voluntarily fix it prior to FDA taking an enforcement action, such as a Warning Letter, import refusal, or import alert. In fact, in the near term, we expect FDA to primarily operate in an education mode – rather than an enforcement mode – with respect to FSVP inspections.

In fact, FDA is still training its own inspection and compliance staff on the regulation. That will take some time. Furthermore, FDA still has not issued any substantive guidance (even in draft form) about how to comply with the rule, even though the statute requires FDA to do so. Moreover, many food importers will not be required to comply with FSVP yet because their suppliers are not yet required to comply with the underlying food safety processing and produce handling regulations. There will be declaration obligations to Customs and FDA when importing food. This means that food importers should ensure their customs brokers know whether FSVP applies. Identifying when the rule applies is as important as what the rule requires.

In order to better predict early behavior around FSVP enforcement, it is useful to remember that Customs and Border Protection and FDA have been working together to implement FSVP as a major advance in pushing food safety responsibilities out to the importer and foreign food processor. Therefore, what is likely to happen on May 31, 2017 is the customs broker hired to file the Customs entry for an imported food shipment will ask the importer to identify the FSVP Importer’s name, contact information and DUNS# (issued by Dun & Bradstreet). For shipments of food that are exempt from FSVP (because the statute or regulation exempts them) or for which FSVP is not yet implemented (because, for instance, the foreign supplier is a “small” food processor), the broker is able to (legally) by-pass FSVP Importer verification. If the FSVP Importer declaration is required, it must be supplied or Customs will reject the electronic entry filing. 

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