Understanding the Foreign Supplier Verification Program’s Requirements
AFI Staff Report
The FDA Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final and compliance dates for many businesses begin May 30, 2017. An importer of food is required to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) to ensure that each food it imports meets FDA food safety standards.
Specifically, an importer’s FSVP must provide adequate assurances that: (a) the importer’s foreign suppliers produce food with the same level of public health protection as those required by FDA for domestically produced food; and (b) the importer’s foreign suppliers produce food that is not adulterated under FD&C Act § 402 or misbranded under § 403(w) (undeclared allergens).
WHO IS COVERED?
With certain exemptions, the FSVP regulations apply to “importers.” For purposes of the FSVP regulations, the “importer” is defined as “the U.S. owner or consignee of an article of food that is being offered for import into the U.S.” The “U.S. owner or consignee” is defined as “the person in the U.S. 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.”
The letters U and S are perhaps the most important in the above paragraph. The law passed by Congress mandates the FSVP importer be a U.S. entity, so non-U.S.-based firms who have for years been importers of record for CBP entries cannot be an FSVP importer and will either have to open a U.S. office or hire a U.S. firm to serve as its agent for FSVP purposes. It’s important to note this agent is different than the facility registration agent; the FSVP agent is the entity FDA will hold responsible for all FSVP compliance. Agreements regarding appointment of FSVP agents must be confirmed via a signed statement of consent by the entity agreeing to be the FSVP agent.
There may also be situations where more than one entity meets the definition of FSVP importer for a given imported food. For example, company A may own the imported food at time of entry but company B may have agreed in writing to purchase the food. In such situations, it’s incumbent on those entities to agree among themselves which entity will be the FSVP importer responsible for compliance with the FSVP regulations.
WHAT IS COVERED?
The FSVP regulations apply to all FDA-regulated food imported or offered for import into the United States, with some partial and somewhat minor exemptions. “Food” includes ingredients in food and beverages, food additives and color additives put in food during processing, dietary supplements and packaging and other food contact substances, though there’s a two-year extension FSVP compliance for food contact substances. Food regulated by USDA is not subject to the FSVP regulations.
WHAT IS AN FSVP?
As noted in the beginning of this article, It’s a program importers covered by the rule must have in place to verify their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.
Importers are responsible for actions that include:
● Determining known or reasonably foreseeable hazards with each food
● Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
● Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
● Conducting supplier verification activities
● Conducting corrective actions
Importers must establish and follow written procedures to ensure they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food. So if an importer trades in three food items each sourced from five facilities, it needs 15 FSVPs. Even in instances in which the information on a food product is nearly the same across suppliers/facilities, a separate FSVP is needed for each facility.
A “qualified individual” must develop the FSVP and perform each of the required tasks. A “qualified individual” is defined as “a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required [under the FSVP regulations], and can read and understand the language of any records that the person must review in performing this activity.” A qualified individual may be an employee of the FSVP importer, an outside consultant or a government employee. A qualified individual must be able to perform only the specific activity or activities it is assigned to perform in the FSVP importer’s FSVP, not necessarily all of the standard FSVP requirements. For example, someone with an understanding the science of the food in question would need to review the preventive control plan submitted by a foreign supplier but that person’s scientific knowledge is not required to compare the items listed on the bill of lading with the items on the purchase order.
RELIANCE ON OTHER ENTITIES
The FSVP importer may rely on other entities to perform most of the standard FSVP requirements, provided the FSVP importer reviews and assesses the other entity’s work and documents its review and assessment. This flexibility is intended to assist FSVP importers that are less knowledgeable about food safety, as well as FSVP importers that do not have a direct commercial relationship with the foreign supplier.
An importer is required to identify and evaluate—based on experience, illness data, scientific reports and other information—the known or reasonably foreseeable hazards for each type of food it imports to determine if there are any hazards requiring a control.
The FSVP importer then must evaluate the identified hazards to determine whether any of the identified hazards is a “hazard requiring a control.” A “hazard requiring a control” is defined as a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish one or more controls or measures to significantly minimize or prevent the hazard. The hazard evaluation must weigh the probability the hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur.
● Biological hazards, including parasites and disease-causing bacteria
● Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens
● Physical hazards, such as glass
They may be hazards reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain, such as substituting a less costly ingredient.
The analysis must assess the probability that these hazards will occur in the absence of controls and the severity of the illness or injury that could occur. The evaluation would have to consider factors that include the:
● Formulation of the food
● Condition, function and design of the establishment and equipment of a typical entity that produces the food
● Raw materials and other ingredients
● Transportation practices
● Harvesting, raising, manufacturing, processing and packing procedures
● Packaging and labeling activities
● Storage and distribution
● Intended or reasonably foreseeable use
● Sanitation, including employee hygiene
An importer can rely on another entity to conduct the hazard analysis, so long as the importer reviews and assesses the relevant documentation.
EVALUATION OF FOOD RISK AND SUPPLIER PERFORMANCE
An importer must evaluate:
● The hazard analysis
● The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier’s raw material or ingredient supplier
● A foreign supplier’s procedures, processes and practices related to the safety of food
● Applicable FDA food safety regulations and information regarding the foreign supplier’s compliance
● The foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems
● Other factors as necessary, including storage and transportation practices
The importer can rely on another entity (other than the foreign supplier) to perform the evaluation of risk, so long as the importer reviews and assesses the relevant documentation. It’s crucial importers remember the evaluation needs to focus on both the food and the supplier and that records must be kept that demonstrate both components were considered.
Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.
Importers have the flexibility to tailor supplier verification activities to unique food risks and supplier characteristics. The options include:
● Annual on-site audits of the supplier’s facility. This is generally required when there is a reasonable probability that exposure to a hazard controlled by the foreign supplier will result in serious adverse health consequences or death to humans or animals (called a SAHCODHA hazard).However, the importer can choose another means of verification provided that the importer documents that the alternate choice is appropriate and provides adequate assurances that the foreign supplier is producing the food in accordance with applicable U.S. safety standards.
● Sampling and testing
● A review of the supplier’s relevant food safety records. An importer can rely on another entity (other than the foreign supplier) to determine and perform appropriate supplier verification activities, so long as the importer reviews and assesses the relevant documentation.
In reviewing the foreign supplier’s compliance history, the FSVP importer is required to search for any FDA Warning Letters and Import Alerts. In addition, the FSVP importer must consider any other regulatory information that is publicly available (e.g., recall press releases, notices of suspension of facility registration) or that the FSVP importer otherwise obtains. FDA intends to create a webpage that FSVP importers can use to easily find compliance history information.
Verification is an ongoing process and each FSVP must constantly be reviewed. A full reevaluation, however, must be performed at least every three years. A reevaluation also must be performed promptly if the FSVP importer becomes aware of new information about new information that could impact the safety of the food produced at the facility, such as if the importer changes its hazard analysis, customer complaints, audit results, FDA refusals of that product or a similar one – whether or not from that particular facility and things such as changes in machinery, management and ownership. If a reevaluation reveals concerns about the safety of the imported food, the FSVP importer must determine whether it is appropriate to continue to import the food from the foreign supplier and whether the foreign supplier verification activities need to be changed. The FSVP importer is required to document the reevaluation.
What if something goes wrong? Importers must promptly take appropriate corrective actions if they determine that a foreign supplier has not used processes and procedures that provide the same level of public health protection as required under the produce safety and preventive controls regulations, as applicable, or that the supplier produces food that is adulterated or misbranded with respect to allergen labeling.
EXEMPTIONS AND MODIFIED STANDARDS
The requirements for dietary supplements vary according to a number of factors, including whether the import is a finished product or an ingredient / component.
● Importers who establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) required under the separate, pre-existing dietary supplement Current Good Manufacturing Practices (CGMP) regulation will not be required to comply with most of the standard FSVP requirements.
● The same would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements.
● Importers of other dietary supplements, including finished products, would be required to comply with most of the standard FSVP requirements (except the hazard analysis requirement) but their verification activities would focus on compliance with the dietary supplement CGMP regulations.
● Modified FSVP requirements are established for very small importers and importers of food from certain small suppliers. (An example of these modified requirements is that certain importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances from their supplier.)
● The definition of very small importer is consistent with the definition of very small business in the preventive controls rules: a sales ceiling of $1 million for human food and $2.5 million for animal food.
● Importers of certain small foreign suppliers are subject to modified FSVP requirements. Those small suppliers are:
● 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
● Shell egg producers with fewer than 3,000 laying hens
Each of these types of producers is either exempt from their underlying FDA food safety regulations or subject to modified requirements, mostly, and in some cases entirely, because of the size of these firms.
There are modified 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.
Additionally, certain categories of imported food are not covered by FSVP. These include:
● Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations.
● Food for research or evaluation
● Food for personal consumption
● Alcoholic beverages and certain ingredients for use in alcoholic beverages
● Food that is imported for processing and future export
● Low-acid canned foods (LACF), such as canned vegetables - but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards).
● Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation.
The effective date for the FSVP provisions is May 30, 2017. As of that date, the Customs entry filings will include fields for identification of the FSVP importer and any exemptions related to that entry. The FSVP importer will be identified via a DUNS number. Importers who don’t have a DUNS number may obtain one via the Dun & Bradstreet and FDA websites.
There are several compliance dates, based primarily on the size of the entities involved. The three major dates are:
May 30, 2017. Companies sourcing from foreign suppliers with more than 500 employees must meet FSVP requirements as of this date. (CBP entries will need to list an FSVP importer as of that date, so even if the entry is not subject to full compliance at that point, it needs a DUNS/FSVP listed in order for the entry to proceed.
March 18, 2018. Importers sourcing from manufacturers with less than 500 employees.
March 18, 2019. Importers sourcing from “very small manufacturers” or importers themselves who qualify as a “very small importer” – average annual (worldwide) sales over the past three years of less than $1 million. These figures include sales of any subsidiaries and affiliates.
The FSVP requirements are supplier-specific. That means an importing company sourcing from several companies may have several compliance dates that apply. Importers may also find that their customers may request the information prior to the actual compliance date. It means importers will need to be in communication with their suppliers and customers well before FSVP is implemented to ensure things are in place with regard to compliance and continuing customer relationships.