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DWPE

FoodFSMA

2012 International Boston Seafood Show

posted by Customs & International Trade Law Blog March 12, 2012 0 comments

The annual International Boston Seafood Show is today and tomorrow at the Boston Convention Center.  The Show attracts 19,000 visitors, and is the largest seafood show in North America.  See www.bostonseafood.com.  I am again lecturing on the Food Safety and Compliance Track with emphasis on the implementation of the Food Safety Modernization Act of 2011: What every food importer and customs broker needs to know – now.

My topic is "Food Safety Compliance under the New Food Safety Modernization Act of 2011."  My fellow panelists discussing the FSMA, and import safety generally, include Ted Poplawski from the FDA, Judith Webster from U.S. Customs and Border Protection (CBP), Howard Tennen from Quirch Foods, Dean Leaman of ABC Research Laboratories, and Dan Fone of NSF International.  Since 80% of the seafood consumed in the United States is imported, compliance with the food safety laws and regulations that have now been implemented by the FDA, in cooperation with CBP, is critical.

There were a record number of FDA Import Alerts for seafood in 2011, and a higher number of imported shipments of seafood are now the subject of Detention Without Physical Examination (DWPE). What is surprising to many people is that the seafood is not just being stopped and inspected from China, but also Vietnam, Chile, and Canada, to name a few.  Moreover, seafood fraud in many forms such as species substitution or false country of origin to avoid the payment of anti-dumping duties is now being discovered by the FDA, CBP, and NOAA.  Criminal prosecutions and civil penalties by CBP are now front page news.

Thank you to Diversified Business Communications, based in Portland, Maine, for again inviting me to be a speaker at the Show.  See www.divbusiness.com.

By the way, the abundance of free seafood is FABULOUS at the Show!

FoodImportImport Alert

How To Get Off The FDA ‘Black List’

posted by Jennifer Diaz August 3, 2009 4 Comments

What is the FDA ‘Black List’?

The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list  (a/k/a the FDA’s ‘Black List’).  To check if a company you are doing business with is on such a list, check FDA’s Import Alert page.   You can search by country, company, etc.  If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States.  An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days.  The company/country, etc. will remain on this ‘Black List’ until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

How to Get Off the Black List

FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the ‘Black List’.  The specific method to use to get off the ‘Black List’ is directly related to why you were placed on the ‘Black List’ in the first place.  For example, if a food product was placed on the ‘Black List’ because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance.  The five shipments must be over a reasonable time period, not one day.  Separately, a Petition must be filed with the FDA requesting that the importer be removed from the ‘Black List’.  The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA’s many requirements. 

It is wise to know whether you or your company are on the FDA ‘Black List’, to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off the FDA ‘Black List’.