In 18 months, June 2017, the Foreign Supplier Verification Program will be mandatory for importers, due to the Food Safety Modernization Act. Importers, or their U.S. Agents, will be required to have documentation on hand to support they have developed a Foreign Shipper Verification Program, for each of the products they import. These programs will most likely require a number of enumerated documents, including, but not limited to: 1) Hazard Analysis, 2) Foreign Supplier Evaluation, 3) Verification of Activities, and 4) Corrective Action Plans. There are different rules for foods for the industry, from very small importers and suppliers, to dietary supplements. There are also several exemptions and consequences of non-compliance, which any company importing food will need to be aware of. This article is meant to address some of these areas.
The importer or the U.S. agent must identify and list all the hazards reasonably likely to cause illness or injury. There are three types of hazards to identify: biological, chemical, and physical. Then, the importer or agent must analyze how they could occur, either naturally or unintentionally or intentionally for economic gain. In order to do this analysis, an importer must employ or outsource a qualified individual–a person with adequate, experience, education or training to conduct such analysis. Thus, the first question that your company will need to answer is how will you qualify such individuals?
Finally the importer must evaluate these hazards, list the controls in place to prevent hazards, and evaluate the likelihood and severity of illness if these controls were not in place. The following factors must be considered for each hazard evaluation: the formulation of the food, the equipment used to process the food, raw materials used, transportation practices, harvestings, raising processing, the packaging, labeling, storage, distribution intended use, foreseeable use, sanitation, hygiene, and any other factors.
An importer may have a third party perform this analysis, or rely on the customer doing their own analysis, but they must independently review the analysis for themselves, and then document that they reviewed it. However, imports of raw agricultural goods, fruits and vegetables, will need to follow extensive rules for those products, which again will lead to additional controls companies in those industries must follow.
With the exception of fruits and vegetables, if there are no hazards requiring control, importers do not need to conduct a foreign supplier evaluation for approval or verification of activities. Nonetheless, they must document the above, in ensuring they have conducted the hazard analysis described.
After completing the hazard analysis, the importer must evaluate the foreign supplier, and approve or refuse the foreign supplier, due to lack of proper controls and compliance. Everything that a hazard analysis identifies, as requiring controls, must be addressed. The importer must review the foreign supplier’s procedures, processes and practices, and then, compare those with current FDA safety regulations. They must also review the foreign supplier safety history, all of which must be documented.
This review may also consider regulations and safety procedures of the country from which the manufacturer is located, if FDA recognizes the exporting country as comparable or equivalent to the U.S. FDA standards. The importer will be required to have information about these, plus testing results, audits, and the foreign supplier responsiveness in correcting problems. Again, all of this evaluation must be documented.
After identifying hazard controls, processes and procedures of foreign suppliers, the importer will then be responsible for verifying these results. This may be in the way of quality testing, on site visits, review of safety records, and any other ways, to verify that food safety hazards are minimized. The risks, and severity of illness or injury, must be evaluated to determine the frequency of each review. The default will require at least annual review, on site audits, and lab tests. Less frequent audits may be warranted only if the results of the Foreign Supplier Evaluation indicate it would be appropriate.
Importers may use the services of qualified third party providers to run these tests or rely on outside audits, conducted by authorized parties, other that the foreign supplier to confirm they are in compliance with the FSMA. However, importers must document their review and assessment of appropriateness of the third parties verification activities, and include that the party conducting the review was a qualified individual.
Finally if any hazards are found, or if there is a chance of persisting to cause illness or injury, the importer must also document all corrective actions that are taken to prevent such risks. Importers must review, verify, and update the Foreign Supplier Verification Program if a new corrective action is taken.
If it is determined, through the verification activities, that a supplier does not produce food in compliance with safety standards the importer must take steps to discontinue accepting food from that supplier, or if it possess a risk conduct a recall. Importers also must have a documented recall plan.
The consequences for not documenting a Foreign Supplier Verification Program include refusal of admission of those foods items from being imported into the US. Another consequence may also be a mandatory recall of that food item. All the records may be kept in electronical form or in physical form but they must be available to be produced to the FDA upon request within a reasonable time. Failure to produce these records in a timely manner may result in refusal by U.S. Customs, to import food.
Disclaimer and Exceptions
There are many exceptions and other inter-threading rules. Each particular food item may have specific regulations addressing it. An Importer will need to examine each food item to address the regulations for that item. Such exceptions are seafood, alcoholic beverages, small importers, food not consumed without further processing, shell eggs, etc. It is likely every importer will need some form of consultation and education, in order to navigate the complexities of the Food Safety Modernization Act.
Visit our Webinars and Seminars page for our upcoming FSVP webinar that will discuss the above and more
Written by: Lowell DeFrance, CHB, J.D.