FDA IssuesFoodImport

I am Not Worried That My Food Is “Safe”, Are You?

posted by Customs & International Trade Law Blog November 10, 2009 2 Comments

The United States Congress is considering legislation to make the food we eat, especially imported food, “safe and secure”.  In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy.  The U.S. Food and Drug Administration (FDA) already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human (or animal) consumption.  The current FDA system is working very well, and  the only achievement of the proposed legislation will be to increase the price of food.  We need enforcement of the current laws, not a bunch of new laws.

Granted, there are numerous instances of imported food making people sick, and even causing death.  15% of the food we eat is imported. Nevertheless, the overwhelming number of Americans who get sick or die from consuming food had nothing to do with imported food.  You may get sick at your local restaurant with food poisoning because of the poor handling of the food at the restaurant, not because the food came from overseas.

Currently, for any food to enter the United States, the importer must submit an electronic entry to both U.S. Customs and Border Protection and the FDA.  The entry information includes the name of the importer, a description of the imported food, the name of its manufacturer, the country of origin, the value, the buyer of the food, and where the food is to be delivered.  The requirements of the Bio-terrorism Act of 2002 require “prior notice” which means that the importer must advise U.S. Customs and the FDA far in advance of the arrival of the food at a border crossing of the United States. The U.S. General Accountability Office just issued a thorough Food Safety Report which has an excellent graphic at page 58-59 describing the imported food procedures.  The Report did state that our food supply is safe, but that U.S. Customs and FDA could do better. 

The Government made significant changes already regarding the traceability of food in the Bioterrorism Act which went into effect in December 2003. It required all foreign companies involved in the manufacturing, processing, packing, or holding food that enters the United States to first register with the FDA so that the food may be traced all the way back from the retailer to its source overseas.  Companies may register on-line at www.FDA-USA.com.   

The prior notice requirement gives the FDA computer system the information to determine what action should be taken on any particular shipment.  Most of the time, the importer gets a “May Proceed” instruction from the FDA, meaning, once the merchandise arrives in the United States, it may promptly proceed to the importer for distribution without any further FDA involvement.  Alternatively, using the Import Alert system, the FDA may automatically refuse the importation of the food into the United States, require more documentation before it may be distributed, or require a physical inspection by an FDA officer.  A physical inspection usually means a sample is obtained and tested at an FDA laboratory to determine if it is in any way contaminated. Chapter 9 (Import Operations ) of the FDA Regulatory Procedures Manual describes in detail the FDA requirements. Every day, all kinds of food products from all over the world are prevented by the FDA from entering the United States, or are sampled for laboratory analysis before getting a “May Proceed” order from the FDA. Failure of a U.S. importer to hold the food for examination or re-deliver food to the FDA will result in a fine from U.S. Customs for three (3) times the value of the shipment.

The proposed legislation, the Food Safety Enhancement Act of 2009, has already passed the U.S. House of Representatives this summer, and is now pending before the U.S. Senate. It would amend the Federal Food, Drug, and Cosmetic Act of 1938 to provide that the importer of the food:

(1) verifies that each facility involved in the production, manufacture, processing, packaging, and holding of the food is in compliance with the food safety and security guidelines developed [by the FDA]; and

(2) ensures that appropriate safety and security controls are in place throughout the supply chain for such food.

It  is unrealistic to expect that a U.S. importer is supposed to verify and ensure that the food it is importing was grown, processed,  warehoused, and transported in compliance with some yet to be written FDA standards.  A U.S. importer typically has no knowledge about or connection with the manufacturer of the food it desires to import. There is an international supply chain that may involve dozens of companies before the food arrives in the United States. In even a simple transaction, just think of the farmer, trucking company, food processor, canning company, warehouse, port terminal operator, and ship or airline that transports the food to the United States.  To legally require a U.S. importer to certify, under penalty of criminal prosecution or a civil fine, to “ensure” everything about the food it imports that may have been produced months ago at a farm or factory overseas is expecting too much.

The proposed legislation has penalties that are just as outrageous. It provides that an individual who commits a violation may be assessed $50,000 for a single shipment, and up to $1,000,000 against a company for a single shipment of food.  If the person commits a violation “knowingly” then the civil penalty for each such violation is huge – $100,000 in the case of an individual, and $7,500,000 against a company for a single shipment.  If that is not harsh enough, the proposed legislation states that “each day during which the violation continues shall be considered to be a separate offense.”  

Food importers are not insurance companies, and simply cannot “ensure” that each any every person or company that previously grew, picked, processed, transported, warehoused, or had any contact with the food overseas complies with whatever regulations the FDA may issue as a result of what may become a new law. So, the next time your stomach is upset after eating a hot dog or hamburger with lettuce and tomato (says Jimmy Buffet) from your local restaurant, don’t blame the lettuce or tomato grower in Mexico, or complain that U.S. Customs and FDA officials are not doing enough. Instead, consider whether the restaurant properly refrigerated or otherwise handled your food before serving it to you.

In a future blog post, I will discuss the FDA PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting) system which will soon be implemented to oversee imported food safety. That will really change things for the better without any new legislation from Washington, D.C.

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2 Comments

Al Germi November 11, 2009 at 8:18 am

This reminds me of the following e-mail I received about a week ago where you can draw some parallels…

Once upon a time the government had a vast scrap yard in the middle of a desert. Congress said, “Someone may steal from it at night.” So they created a night watchman position and hired a
person for the job.

Then Congress said, “How does the watchman do his job without instruction?” So they created a
planning department and hired two people, one person to write the instructions, and one person to do time studies.

Then Congress said, “How will we know the night watchman is doing the tasks correctly?” So they created a Quality Control department and hired two people. One to do the studies and one to write the reports.

Then Congress said, “How are these people going to get paid?” So They created the following positions, a time keeper, and a payroll officer, Then hired two people.

Then Congress said, “Who will be accountable for all of these people?” So they created an administrative section and hired three people, an Administrative Officer, Assistant Administrative Officer, and a Legal Secretary.

Then Congress said, “We have had this command in operation for one Year and we are $18,000 over budget, we must cutback overall cost.”

So they laid off the night watchman.

NOW slowly, let it sink in.

Does anybody remember the reason given for the establishment of the DEPARTMENT OF ENERGY…. during the Carter Administration?

Anybody?

Anything?

No?

Didn’t think so!

Bottom line. We’ve spent several hundred billion dollars in support of an agency…the reason for which not one person who reads this can remember!

Ready??

It was very simple…and at the time, everybody thought it very appropriate.

The Department of Energy was instituted on 8-04-1977.

TO LESSEN OUR DEPENDENCE ON FOREIGN OIL.

Hey, pretty efficient, huh???

AND NOW IT’S 2009 — 32 YEARS LATER — AND THE BUDGET FOR THIS “NECESSARY” DEPARTMENT IS AT $24.2 BILLION A YEAR. THEY HAVE 16,000 FEDERAL EMPLOYEES AND APPROXIMATELY 100,000 CONTRACT EMPLOYEES; AND LOOK AT THE JOB THEY HAVE DONE!

THIS IS WHERE YOU SLAP YOUR FOREHEAD AND SAY, “WHAT WAS I THINKING?”

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eCustoms December 3, 2009 at 2:26 pm

Fab, thanks…

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