The U.S. imports approximately 19 percent of its total food supply, including 80 percent of seafood, 52 percent of fresh fruits, and 22 percent of fresh vegetables (USDA Economic Research Service, 2013). Although food and beverage comprised the smallest imported product category in 2017, the U.S. imported approximately $115.5 billion of animal and plant foods and $21.8 billion of beverages excluding liquors (USDA Economic Research Service, 2018).
One of the main factors contributing to this sizeable volume in imported foods is the dramatic change in food preferences brought about by an increase in the non-Caucasian population in the U.S. As of November 2016, Pew Research Center estimated baby boomers, those born 1946-1964, comprised approximately 70 million people and were about 28 percent non-white. Generation X, those born 1965-1980, comprised 57 million and was about 40 percent non-white, an almost 43 percent increase in ethnic diversity from the baby boomers. Generation Y/millennials, who were born 1981-1996, numbered 62 million during the same time period. Millennials were about 44 percent non-white. Generation Z, composed of those born after 1996, was estimated at 65 million and was almost 50 percent ethnically diverse.
Every generation has characteristics specific to their population. For example, baby boomers led the demand for fresh and less processed foods, organic, and sustainability—food and beverage trends that we still see today. Generation X depended on nutrition information on food labels to make their choices and were increasingly adventurous with the food they chose. The millennials sought variety in foods, including experimenting with new ethnic foods. The millennials also readily integrated technology in their daily lives, sharing their food experiences with their digital social network, thus broadening the exposure and ultimately the acceptance of ethnic foods. The youngest and fast-growing population who grew up completely in the digital age, Generation Z, preferred authentic, global food experiences that they also electronically shared with their contemporaries and affected the other aspects of their lives. Diversity in foods is becoming the norm and imported foods are projected only to increase in volume.
Imported Foods Called for FSVP
To assure imported foods are of the same level of public health protection as food produced in the U.S. and are not adulterated or misbranded with respect to allergen labeling, the Foreign Supplier Verification Program (FSVP) was published in the Federal Register on Nov. 27, 2015. FSVP changed the focus on food contamination from reactive to preventive and required importers to conduct risk-based verification activities. This was largely driven by high-profile food outbreaks involving imported food and food ingredients, including the 2009 scandal of imported Chinese melamine-contaminated milk used to prepare infant formula, liquid milk, ice cream, other foods containing dairy products, and animal feed. There were at least three confirmed deaths, approximately 53,000 babies who received treatment mostly for kidney damage, and over 20 companies involved in the scam.
The FSVP importer is defined as the U.S. owner or consignee of an article of food for import into the U.S. If there is no U.S. owner or consignee of the food at the time of entry into the U.S., the FSVP 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. Standard FSVP requirements include a hazard analysis of each imported food (or type of food), evaluation of foreign supplier’s performance and the risk posed by the imported food, foreign supplier approval, appropriate supplier verification and related activities done by “Qualified Individuals,” corrective action when necessary, and keeping records of the FSVP activities. Although persons with technical backgrounds do not find FSVP requirements difficult to comply with, they describe compliance as a tedious, time-consuming responsibility. Importers, who do not possess the technical knowledge, often feel overwhelmed and intimidated by the required FSVP tasks. Qualified Individuals who may or may not be employees of the importers are allowed to perform FSVP activities.
A very small importer is one whose annual average in food sales, and the U.S. market value of food imported, processed, packed, or held without sale, during the previous three-year period is less than U.S. $1 million in human food or less than U.S. $2.5 million in animal food. The very small importer, small foreign supplier, importers of dietary supplements/components, and importers of certain foods from countries with food safety systems officially recognized by the U.S. FDA as equivalent to that of the U.S. are under modified FSVP requirements. These clauses exclude them from having to conduct hazard analyses of the imported food, evaluate the risk of the food, evaluate the foreign supplier’s performance, implement a foreign supplier approval program, or meet certain recordkeeping requirements. There are other requirements of very small importers and their foreign suppliers that cannot be discussed adequately in this column.
There are also foods exempt from FSVP requirements. Exempted foods include those regulated under the FDA seafood and juice HACCP (Hazard Analysis and Critical Control Point) rules and raw materials and ingredients used for those foods; meat, poultry, or egg products under the USDA regulation; certain alcoholic beverages and raw materials and ingredients for those beverages; those intended for personal or research use and not for sale or distribution in the U.S.; those manufactured or processed, raised, or grown in the U.S. then exported but not subjected to further manufacturing or processing and returned to the U.S.; foods transshipped through the U.S. but not for sale or distribution in the U.S. then exported; foods imported for processing in the U.S. but not for sale or distribution in the U.S. then exported; and low-acid canned foods and raw materials and ingredients for such foods but only for microbiological hazards.
Implementation of the FSVP requirements, however, is still proving to be difficult even for importers eligible for modified requirements. Below are some of the concerns shared with me during my interviews with processors and customs brokers.
Varying FSVP Enforcement Dates
According to some small food processors, they were advised by U.S. FDA that they will probably not see FSVP enforcement for another two years, i.e., by 2020. Other food processors are stating, however, that they are currently seeing enforcement. The FDA may enter any food facility under its jurisdiction at any time of food manufacture, leaving the food processor uncertain when to expect the FDA investigator—leading to increased anxiety levels brought by the unknown.
It is recommended the FDA conduct updates for the industry clarifying FSVP compliance and enforcement dates.
Obtaining a Foreign Supplier’s Food Safety Plan
Having a working food safety plan may be routine practice in most regions in the U.S., but is still considered novel in other areas including overseas. Some processors have encountered foreign suppliers who prefer not to share their food safety plans because those are considered “proprietary.” There is a misunderstanding about the purpose of a food safety plan. It is not understood or accepted that asking for a food safety plan from suppliers and customers is a standard procedure. The food safety plan demonstrates that the processor has evaluated the risks associated with a food item or ingredient, and if the severity of the risks significantly impacts the safety of the food, at least one preventive control must be identified. The food safety plan also details what corrective actions should be taken when deviations occur, including steps to prevent their recurrence. These actions are verified by various means including records review with management sign-off. These records must be kept as evidence of what the food processor declared as critical in protecting the safety of its food.
To assist very small importers and small foreign suppliers in complying with FSVP, modified requirements grant them exemption from most of the standard requirements, including conducting a hazard analysis of the imported food or ingredient. Without a hazard analysis, there is no working food safety plan. But as is currently occurring in the food industry, these exemptions do not stop a buyer or an auditor from demanding a working food safety plan whether or not it is required.
Difficulties in Reviewing a Food Safety Plan
If the FSVP importer can obtain the foreign supplier’s safety plan, a thorough evaluation of each imported food item (or type of food) is required, unless the imported food is exempt or under modified requirements. If the importer is the U.S. processor or manufacturer, it is already devoting a substantial amount of time developing, monitoring, and maintaining all the elements of a working food safety plan. The FSVP further requires the importer to spend additional time analyzing its foreign supplier’s food safety plan. Some importers have neither the technical background for such analyses nor the time to allot for review. The requirement for the Qualified Individual to read or understand the documents in the language of the foreign supplier further handicaps the U.S. importer. Although the importer understands that its Qualified Individual may perform these FSVP verification activities, some importers are having difficulties searching the already tight employment market then employing another staff member with technical qualifications. Hiring a Qualified Individual as a consultant imposes financial burden to the importer and will most likely not encourage the degree of involvement that is desirable between the importer and its FSVP.
The importer understands there are alternative verification procedures, such as internet searches of publicly available documents describing the foreign supplier’s food safety records. Internet search can be accomplished without significant problems or costs. Sampling and testing of food samples is another FSVP task, but this activity is already costing the food processor tens of thousands of dollars prior to implementing a FSVP. In addition, sampling and testing is not a definitive tool for ensuring food safety and is a major reason for the development of the HACCP system. The preferred FSVP verification activity, an onsite audit, also poses a significant financial cost to the importer.
These are issues that will entail several solutions that cannot be completely discussed in this column.
Customs Brokers—The Forgotten Partners
Importers have a natural close working relationship with their customs brokers. Brokers field questions on the process and the product and try to resolve issues expediently. Customs brokers expect their clients (importers) to ask them about FSVP and consider it their responsibility to be familiar with the program, its requirements, and their possible role in alleviating some of the anxiety importers have with FSVP. Some have been asked to be the FSVP importer for the products brought into the U.S., a request that brokers reasonably decline. But if a customs broker is located in the U.S. and purchases the food and distributes in the U.S., the broker could become the FSVP importer and is expected to meet FSVP requirements, including a hazard analysis of the purchased food.
The current objective of the customs broker is to at least understand the FSVP issues raised to them and be able to refer importers to the appropriate persons who could assist them. Importers are their customers, and brokers would like to maintain them as satisfied customers.
An issue that brokers have raised is LTL, or less than truckload, of imported products. Although the very small importer may operate under modified FSVP requirements that should assist them with the timely compliance to the rule, importers also have to address sanitary transportation issues. LTLs are susceptible to cross-contact and cross-contamination due to the presence of other products in the shipping or road container and the various stops at different customers. LTLs are already occurring in importation and brokers manage them for their importers, but the additional food safety rules increase the cost of operations for both the importer and the broker. Brokers, however, stated they will fully cooperate with their importers in addressing FSVP issues.
It’s recommended that the U.S. FDA continue to include customs brokers in its FSVP update sessions.
What are the Next Steps?
There are modified requirements designed specifically for the very small importer and small foreign supplier. Although FSVP exempts the food from certain FSVP requirements, buyers are continuing to ask for a food safety plan prior to the purchase of the food or food ingredient. This is a reasonable request. Any processor can make people sick, regardless of the company size. When a buyer asks for a food safety plan, the seller produces a food safety plan. Thus, as a trainer, I advocate not depending on exemptions and modified requirements when food safety is concerned. Having a working food safety plan is not only good manufacturing practice but also good business.
Dr. Saulo is a professor and extension specialist in food technology at the University of Hawaii at Manoa. Reach her at aurora@hawaii.edu.
Good Article! It helped me to understand what difficulties one can face during FDA Registration after the FSVP rule arrived.