U.S. R EGULATIONS FOR I MPORTED FOODS

FDA R EQUIREMENTS Must comply with same US laws and regulations as domestic foods  GMPs  HACCP  Labeling  errors account for > 22% of detentions  Low acid canned foods  Importer must have:  food canning establishment registration on file with FDA  scheduled process filing with FDA

FDA R EQUIREMENTS Registration of foreign facilities and US agent Prior notice of import shipments  must be received no more than 5 days before arrival and no fewer than:  2 hours if by land by road  4 hours if by air or land by rail  6 hours if by water

FDA R EQUIREMENTS Administrative detention  based on past history and/or other information indicating the product may be in violation Maintenance of records  for all foods accepted for entry into the US  foods with < 60 day shelf-life - 6 months  foods with 60 days to 6 months shelf-life – 1 year  foods with > 6 month shelf-life – 2 years

A SSISTANCE FOR I MPORTERS Private companies offering assistance  e.g., Registrar Corp. (Virginia, USA)

A SSISTANCE FOR I MPORTERS Registrar Corp.  provides assistance with import regulations  not free!!  Registration of facility - $195  free of charge with FDA  Prior notice of shipping registration - $29.95/shipment  free of charge with FDA (pending FSEA)  Label/ingredient design - $1,495/product  FDA does not do this

FDA I NSPECTION OF I MPORTS Food arrives at the port  agent files entry notice and posts bond (3x value) US Customs notifies FDA (electronic) FDA elects NOT to examine – article enters commerce FDA elects to examine shipment  passes inspection →→ article enters commerce  fails inspection →→ article is refused entry  re-exported  destroyed  petition for reconditioning Once the article enters commerce, it is considered as domestic

USDA R EQUIREMENTS Must come from eligible countries and certified establishments  made by application Must be approved by USDA’s Animal and Plant Health Inspection Service  disease concerns Compliance with prerequisite programs  GMPs  SSOPs  HACCP

USDA R EQUIREMENTS Company must undergo an equivalency determination process  document reviews  laws, compliance, disease issues, etc.  on-site audits  technical team conducts the audit  must comply with same US laws and regulations as domestic meat, poultry, and egg products Must present items for inspection at an official port establishment (~327 ports in the US)

USDA R EQUIREMENTS Inspection at port of entry  inspection records from exporting country  post-mortem only  denied  exported or destroyed  accepted  USDA inspected and passed  treated as domestic from this point forward

US I MPORT R EGULATIONS Not a complex process Can be problematic for some importers  language issues  poor understanding of regulations On site compliance verification Inspection based on history of compliance  ~ 2% of imported items are actually inspected