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.
