|2004N-0234 - Annual Guidance Agenda|
|FDA Comment Number :||EC2|
|Submitter :||Ms. Paula Bartholomy||Date & Time:||07/28/2004 11:07:03|
| Division of Dockets Management (HFA-305)
The Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
To: Division of Dockets Management (HFA-305)
Re: Program Priorities in the CFSAN, Request for Comments.
Docket No. 1998N-0359
I am writing to provide input on the program priorities for the Center
for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2005.
Public health concerns exist concerning imported farm raised shrimp; and
therefore, I recommend that the Food and Drug Administration should
prioritize inspections of imported shrimp for FY 2005.
Approximately 80 percent of the shrimp consumed in the United States is
imported, over half of which is farmed raised. Some chemicals, such as
chloramphenicol and nitrofurons, are used around the world to raise
shrimp in coastal farms for exportation to the United States.
Chloramphenicol is linked to human aplastic anemia, intestinal problems,
and neurological reactions; nitrofurons have been found to be
carcinogenic. As you know, these chemicals are actually banned by FDA.
Imported shrimp inspections fall under the FY 2004 workplan, and should
be included in the FY 2005 workplan as well. Imported shrimp
inspections uphold the FDA's domestic health standards, as well as
ensure international compliance with U.S. food safety rules. In order to
guarantee that imported shrimp is safe for American consumers and that
it adheres to the current FDA guidelines on chemical usage in foods,
shrimp inspection should be a priority, and placed on the FDA CFSAN
"A-list" for FY 2005.
I urge the FDA to recognize its mandate of ensuring a safe food supply
by prioritizing imported shrimp inspections and taking the following
1. For one year, inspect 100% of shrimp imported into the United States
for banned chemicals, such as chloramphenicol and nitrofurons. This will
allow the FDA to better understand the extent of the problem.
2. Once the year of 100% testing is complete, the agency should devise
a testing program for imported farm raised shrimp that is based on the
prevalence of banned chemicals found during the total testing period.
3. If shrimp entering the U.S. is detected with residues of banned
chemicals, the contaminated shrimp must be destroyed, rather than dumped
back on consumers in the country of origin or used in animal feed.