By Mark Huffman and
Lisa Wade McCormick
December 1, 2008
Under increasing criticism for its oversight of the nation's food
supply, the U.S. Food and Drug Administration (FDA) has issued a plan to better protect from accidental and
Protection Plan, which outlines strategies for prevention, intervention
and response, is designed to address food safety and food
defense for both domestic and imported products and covers the full
lifecycle of food, by encouraging the building of safety into every step of
the food supply chain, the agency said.
"Science and 21st century technologies help drive the FDA's efforts
to transform our food safety efforts from the Food Protection Plan into a
reality," said Commissioner of Food and Drugs
Andrew C. von Eschenbach, M.D. "Every day,
is working with foreign countries, state and local governments, regulated
industry and consumer groups to ensure the safety of the food supply. We
also continue to work with members of Congress to achieve new authorities
requested in the Food Protection Plan."
The plan is designed to reassure the public and Congress that the FDA
can reform itself to provide needed protections. Rep. Rosa DeLauro
(D-Conn), a frequent FDA critic, said she is trying to keep an open mind,
but remains skeptical about the agency.
"It's got to be so totally redone," DeLauro told the New York
Times. "It needs resources; it needs better management; it needs less
influence from the industry and more influence on the science."
In addition to revealing its plan, the FDA also listed what it called
the agency's accomplishments in implementing the Food Protection Plan's
three core strategies: prevention, intervention, and response.
Among the accomplishments the agency cited in its report:
Establishing offices in China,
India, Europe, Latin
America, and the Middle East -- all regions that export food and other
FDA-regulated products to the United States. The FDA has
hired staff in China and
India and its officials
were part of a U.S.
delegation to China to
address food safety issues, including the melamine contamination of dairy
products in China;
• Releasing its CARVER self-assessment tool to minimize the risk of
intentional contamination of food;
• Meeting with more than 200 federal, state, local, tribal and
territorial partners to address ways to protect the nation's food supply;
• Hiring an International Notification Coordinator to manage information
exchanges between the FDA and its foreign counterparts;
• Approving the use of irradiation of iceberg lettuce and spinach to
such as E-coli;
• Developing methods to detect melamine and cyanuric
acid in feed and feed ingredients;
• Using genetic analysis to identify hundreds of Salmonella strains from
• Inspecting 5,930 high-risk domestic food establishments;
• Developing a rapid detection method to identify E. coli and Salmonella
in food. This is now used in poultry-processing facilities to detect and
prevent bacterial contamination during food processing;
• Expanding its database to include adverse feed events. This means the
FDA can respond faster to outbreaks of feedborne disease
in animals, contamination episodes, and/or product defects;
• Working with industry and the public to identify ways to trace fresh
produce throughout the supply chain;
• Hiring two emergency /complaint-response coordinators to improve its
response to emergencies that involve animal feed, including pet food;
• Working with state and local officials to inspect more than 2,100
stores for Chinese infant formula contaminated with melamine;
After reports from China
of melamine-contaminated infant formula, the FDA worked with its state and
local counterparts to quickly canvas over 2,100 Asian markets to remove any
infant formula from China
that might be available and to sample milk-derived products to check for
Many U.S. consumers
are fearful about melamine and cyanuric acid
contamination in products imported from China.
Just a few days ago, the FDA confirmed it found traces
of melamine in Good Start Supreme Infant Formula and traces of cyanuric acid in Enfamil LIPIL with iron.
The FDA, however, said the formulas were safe because of the low levels
of those chemicals.
That announcement reversed the position the agency took less than two
months ago when it said it would not allow any melamine in infant formula.
This latest discovery comes just months after Chinese officials blamed
melamine-tainted infant formula for the deaths of four babies in that
country and the illnesses of 53,000 others.
Melamine and cyanuric acid are also the
chemicals blamed for the 2007 pet food recall -- the largest in U.S. history.Thousands
of dogs and cats became sick or died after eating pet food made with
tainted wheat gluten imported from China.
But FDA officials say they have--since the agency first outlined its
Food Protection Plan in November 2007--made significant strides to protect
the country's food supply.
Today's report, however, doesn't appease all the FDA's critics.
"I've tried to be open about when they come in and say they are
doing this and doing that," DeLauro said. "But at every step,
they fail on just such a large scale."
DeLauro said the FDA's position on melamine in infant formula--first
stating it would allow none and then saying trace amounts were not
harmful--illustrates what she calls the agency's "continued
Today's report also did little to change consumer Carol V.'s opinion of the FDA. This Rhode Island woman has been leery of the
agency since her two cats became gravely ill last year after eating Special
Kitty food tainted with acetaminophen. Last December, she made the tough
decision to euthanize one of her beloved cats.
"My lack of confidence in the FDA that first happened in March 2007
due to the pet food crisis has not been alleviated by reading this report
and also by the absence of the implementation
of the FDAAA," Carol told us today. "I see where the FDA has
held meetings and set up offices, yet we are still seeing problems as
recent as this month with the again expanded salmonella recall with Mars
Pet Foods to the discovery of melamine and cyanuric
acid in US made baby formula.
"I still see a reactive FDA, not a proactive FDA," she added.
"I see nothing in this article making it a greater risk than benefit
to adulterate foodstuffs. I see no immediate ability to track our food
supply in the US
or abroad. The few offices being set up abroad can not possibly control the
foodstuffs coming into our country."
Carol said she is still worried about the safety of the U.S. food
"I am afraid. Because I was affected by the importing of a contaminant
I am especially concerned that I do not see any increase in inspections of
imports or detention of suspected imports. I truly see a lot of words but
little true action. I do not see the hugely ambitious plan that I was
hoping to see."