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FDA Rolls Out Food Safety Plan

Agency touts accomplishments, sidesteps criticism for melamine response





By Mark Huffman and Lisa Wade McCormick
ConsumerAffairs.com

December 1, 2008

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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 intentional contamination.

The Food 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, the FDA 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 control pathogens, 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 seafood imports;

• 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;

"Continued dysfunction"

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 melamine contamination.

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 dysfunction."

"Reactive, not proactive"

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 supply.

"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."



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