On February 17, 2011, around the time the Food Safety Modernization Act (FSMA) became law, Michael R. Taylor, FDA deputy commissioner for foods, spoke before the Global Food Safety Conference in London, England stating: “Importers will, for the first time, have a clearly defined responsibility and accountability for the safety of the food they [import].”
Concern about food safety since then has only heightened against a backdrop of serious food safety lapses in countries like China and its milk scandal. One basis for objection by food importers to the complex new regulations is all shipments are reported to FDA at time of importation, but the same is not true of U.S. domestic food production, a frustration for importers as the vast majority of food related illnesses have been associated by the CDC with domestic production. On November 3, 2011, CNN ran a story about the 10 biggest foodborne illnesses of the decade, while the 10 cases cited were serious, eight related to solely U.S. processing, while the two imported incidents involved Mexican peppers and cantaloupes.
The concept of risk management is not new, even to FDA. For years, Hazard Analysis and Critical Control Points (HACCP) plans have been required for imports of seafood, juice, and low acid canned food, but are voluntary for dairy product. HACCP operates on the principle each member in the supply chain must identify potential hazards and minimize or eliminate them during production or handling, but if that fails, manage them when they arise. This concept has been expanded by the FSMA to all imported food. The definition of food is broad and encompasses articles used for food or drink for man or animals; chewing gum; and inputs, ingredients and components for such articles, including dietary supplements, but not pesticides. FDA is able to inspect barely 1 percent of these food imports, so the focus is on prevention mechanisms and that is where the burden is greatest on smaller companies due to higher risk and compliance costs in an already tough economic environment. Cost alone can no longer drive the deal.
An importer is here defined as the U.S. owner or consignee at time of entry, or, if there is none, the U.S. agent or representative of the foreign owner or consignee. Under the proposed rules, importers must now ensure their foreign suppliers comply with FDA safety rules or equivalent local regulations. The clearest expectations come from the newly proposed foreign supplier verification (FSVP) rules wherein the importer is expected to focus on foreseeable food safety risks identified through a hazard assessment process, not every possible risk. The regulatory requirements differ depending on the type of food product or dietary supplements; category of importer; nature of hazard; and who controls it.
The proposed FSVP rules require importers do much more homework and keep records of such actions as the following.
• Review the compliance status of the imported product(s) and foreign supplier(s), including warning letters, import alerts and required certifications.
• Analyze the hazards associated with each food and evaluate the severity of the illness or injury, if such hazard occurs, with more robust efforts mandated as the hazard risk increases.
• Importers must maintain a written list of foreign suppliers; establish written verification procedures; and verify that reasonably likely to occur hazards are adequately controlled.
o If the importer or its customer/buyer controls the hazard, the importer must document such controls, including obtaining buyers’ certification if they control the hazard.
o If the foreign supplier controls the hazard or its compliance is verified as being controlled by its raw material/ingredient supplier, there are two options to choose from.
Option 1 – Importer must conduct onsite auditing of the foreign supplier or rely on an inspection by FDA or the approved food safety authority in the country for the reasonable probability exposure that will result in serious adverse health consequences or death, or hazards in certain raw agricultural commodities. For others, importers may choose onsite auditing, periodic or lot-by-lot sampling and testing, periodic review of the supplier’s food safety records, or other appropriate measures.
Option 2 – Importers may choose from the various verification options for all types of hazards, so long as the chosen verification activities are sufficient to ensure the hazards presented are adequately controlled.
Whichever option is chosen, the importer must implement and revalidate it every few years or sooner as circumstances warrant.
These initial steps are costly on their own, but then importers are expected to review complaints, investigate adulteration or misbranding, and take corrective actions in noncompliance cases, including supplier termination, plus reassess the suppliers’ activities if new information arises about potential hazards, or otherwise every three years.