Tuesday, February 16, 2016

Get Ready for FDA's New Foreign Supplier Verification Program.

Foreign Supplier Verification Program.
            In 18 months, June 2017,  the Foreign Supplier Verification Program will be mandatory for importers. Importers or their US Agents will have to have documentation on hand at the ready, that they have developed a Foreign Shipper Verification Program, for each they product import.  These programs will most require a number of enumerated documents, 1) Hazard Analysis, 2) Foreign Supplier Evaluation,  3) Verification of Activities, and 4) Corrective Actions. There are different rules for foods from very small importers from very small  suppliers, and dietary supplements.  There are also several exemptions and consequences of non compliance.
1.    Hazard Analysis.
            The importer or the US agent must identify and list all the hazards reasonable likely to cause illness or injury. There are three types of hazards to identify:  1) biological, chemical, and physical. Then the importer or agent must analyse how they could occur, either naturally, unintentional or intentional 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.
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, harvesting s, 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. then they must document that they reviewed it. However, imports of raw agricultural goods, fruits and vegetables, needs to follow extensive rules for fruits and vegetables.
With the exception of fruits and vegetables, if there are no hazards requiring control, importers do not need conduct a foreign supplier evaluation for approval or verification of activities. Nonetheless, they must document conducting the hazard analysis described.  
2.    Foreign Supplier Evaluation for Approval
After completing the hazard analysis every imported of food, the importer must evaluate the foreign supplier, and approve or refuse the foreign supplier. Everything that hazard analysis identified as requiring controls must be addressed. The importer must review the foreign supplier’s procedures process and practices compare those with current FDA safety regulations. They must also review the foreign supplier safety history. all of this again must be documented.  
This review may also consider regulations and safety procedures of the country from which the manufacture 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 and testing results, audits, and the foreign supplier responsiveness in correcting problems. Again, all of this evaluation must be documented. 
3.    Verification of Activities.
            After identifying hazards controls, process and procedures of foreign suppliers, the importer will then be responsible for verifying these results. This maybe in the way of quality testings, on site visits, review of safety records, and any other ways, to verify the foods safety and 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 reviews, 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 test. Importers may rely on outside audits, conducted by authorized parties, other that the foreign supplier. However, importer must document their review and assessment of appropriateness of the the third parties verification activities. Included in that review must also determine the party conducting the review was a qualified individual.
4.    Correction Actions.
            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 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 electronic 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 of admission of imported food.
Disclaimer and Exceptions
There are many exceptions and other inter threading rules. Each particular food item may have specific regulation 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 more consultation.