Monthly Archives

April 2010

FDA IssuesFoodImport

THE FDA IS FLEXING ITS ENFORCEMENT MUSCLES

posted by Customs & International Trade Law Blog April 22, 2010 0 comments

At today’s Food and Drug Law Institute’s annual conference in Washington, D.C., FDA Commissioner Margaret Hamburg, M.D. said that one of her priorities is responding to the globalization of the food supply, and the increase in misbranded and adulterated food products imported into the United States.  Dr. Hamburg stated that the FDA "cannot wait until the food arrives at our borders," that "extending the FDA’s global reach is key to our success," and that the FDA’s new PREDICT system will focus FDA Inspectors to select, stop, and examine high-risk shipments being imported into the United States.

Ralph Tyler, FDA’s new Chief Counsel, stated that the laws enforced by the FDA affect 25% of the American economy.  The crowd in attendance applauded when Ralph stated that "FDA lawyers are not doing their jobs when they simply say ‘no’" to the food, drug, and cosmetic companies regulated by the FDA.

Michael Chappell, FDA’s Associate Commissioner for the Office of Regulatory Affairs (ORA), is the person responsible for managing the import, inspections and enforcement policy of the FDA.   He stated that companies are now operating in "an age of heightened enforcement by the FDA."  He stated that "salmonella and listeria remain major problems in food manufacturing facilities."  He advised that there were 19 million customs entries in 2009, and the number is ever increasing.   He stated that the FDA had in 2010 already issued a record number of Warning Letters to importers, producers, and distributors of FDA regulated products, especially dietary supplements and cosmetics.

In summary, my take away after hearing from the top 3 people at FDA is that it is a much more aggressive agency under the leadership of Dr. Hamburg than previously.  Importers should be more careful than ever to understand and comply with the FDA regulations, or not be surprised to receive a Notice of Refusal, a Warning Letter, or even a civil penalty or subpoena.

Customs BrokerU.S.Customs

NATIONAL CUSTOMS BROKERS AND FORWARDERS CONFERENCE

posted by Customs & International Trade Law Blog April 15, 2010 0 comments

The annual conference of the National Customs Brokers and Forwarders Association of America (NCBFAA) just concluded in San Antonio, Texas. Several prominent speakers from U.S. Customs, the Federal Maritime Commission, the U.S. Census Bureau, the Bureau of Industry and Security, the Office of Foreign Assets Control, Transportation Security Administration, and the Department of Homeland Security discussed new policies and procedures that every customs broker and international freight forwarder should use to serve their import and export clients.

Deputy Commissioner for U.S. Customs, David Aguilar, used a new talking point in his repeated use of the phrase "protect the American way of life" which apparently has replaced "protect the border" in his description of the mission of the U.S. Customs and Border Protection.  U.S. Customs Senior Attorney Susan Terranova stated that in 2009, Customs had issued over 500 penalties against exporters and freight forwarders for failing to file timely or accurately complete Automated Export System (AES) filings. Each penalty was issued in the amount of $10,000.

Marc Rossi, Branch Chief, Certified Cargo Screening Program, Air Cargo Division, TSA, stated that there are 98 foreign flagged airlines that fly into the United States, over 4,000 indirect air carriers (IACs), 52 independent cargo screening facilities, and only 403 IACs certified by the TSA as Certified Cargo Screening Facilities (CCSF), in preparation for the August 1, 2010 100% screening of air cargo aboard passenger aircraft in the United States.  More information about the implementation of the 100% screening rule is available at www.tsa.gov/ccsp

Along with Brandon Fried, Director, Air Forwarders Association, I lectured at the NCBFAA Conference about Export Compliance for Freight Forwarders.  The focus of my presentation was on exactly how to mitigate penalties once a Proposed Charging Letter, Pre-Penalty Notice, or Notice of Proposed Penalty has been issued by BIS, OFAC, or TSA.  The Power Point presentation is available only upon request.

TSA

TSA 100% CARGO SCREENING RULE EFFECTIVE AUGUST 1, 2010

posted by Customs & International Trade Law Blog April 7, 2010 1 Comment

On January 11, 2010, I posted "You Ready for 100% Cargo Screening by the TSA" because at that time, the international aviation industry was not prepared for the implementation on August 1, 2010 of the TSA mandated 100% screening of air cargo aboard passenger planes.  The date is fast approaching, and shippers, indirect air carriers (freight forwarders) and airlines which need to get "on board" should attend an upcoming seminar.

The Council of Supply Chain Management Professionals South Florida Roundtable is hosting an excellent, informative seminar the morning of Friday, May 7, in Ft. Lauderdale, Florida. Presenters includes the Assistant Branch Chief of TSA from its Headquarters in Arlington, Virginia, and knowledgeable professionals who have already led the changes at American Airlines, DHL, and others. The seminar will focus on the practical steps that shippers, IACs, and air carriers must know, including how to comply with TSA’s Certified Cargo Screening Program (CCSP) and become a Certified Cargo Screening Facility (CCSF).  Registration for the seminar may easily be done on-line.

TSA

DOES TSA’s 3-1-1 RULE FOR PASSENGERS’ CARRY-ON BAGS MAKE SENSE TO YOU?

posted by Customs & International Trade Law Blog April 6, 2010 5 Comments

I just returned from a wonderful trip to both Italy and Israel, and I can’t help but compare our Transportation Security Administration (TSA) procedures to that of other countries.  In both Italy and Israel, I did not have to take off my shoes or follow the all too familiar 3-1-1 TSA enforced liquid policy. Yet, on April 2, 2010, Department of Homeland Secretary Napolitano announced another set of security measures that hassle passengers who travel by air.

As you may recall, TSA implemented the 3-1-1 policy in response to the thwarted liquid explosive bomb plot in the United Kingdom in August of 2006. The current TSA 3-1-1 rule for carry-on bags is that liquids and gels must be in a 3.4 ounce (100ml) bottle or less (by volume) , put in a 1 quart-sized, clear, plastic, zip-top bag, and that there is only 1 bag per passenger placed in screening bin. I would really like to know the scientific basis for why 3.4 ounces, and why a 1 quart-sized bag?  Who comes up with this stuff at TSA or DHS? And if it is so necessary to protect the traveling public, why does neither Italy or Israel follow the same rules since they both have far more experience with terrorism than the United States?

I am a customs and international trade lawyer, not a security expert. I don’t pretend to know the difference between a millimeter wave or backscatter body imaging system, I just am not thrilled about taking my shoes off or separating my liquids in my carry-on bag when going through TSA if it is not absolutely necessary (as it is not in both Italy and Israel). Civil libertarians are opposed to the new, anatomically revealing technology on all travelers, and consider the body scanners an invasion of privacy that is akin to a strip search. The devices detect objects concealed under clothes and can produce detailed images of the body.  According to Jay Stanley, public education director for the technology and liberty program at the American Civil Liberties Union (ACLU), he sarcastically announced that "We would certainly all be safer on airlines if we all flew naked."

I am all for TSA’s risk management approach to aviation safety, and I sure like to know that when I get on an airplane, it will safely take me from one city or country to another.  In Israel, I saw exactly the same x-ray machines as we have in the United States, but I did not see in Israel or Italy any canine teams or the use of the very controversial advanced imaging technology that the TSA is now promoting in the United States. So, I ask the question again, why does the TSA think they know better how to handle aviation safety than the law enforcement agencies in Italy and Israel?