WASHINGTON — The U.S. Food and Drug Administration drew a mix of praise and criticism here last week after reporting the progress made with its year-old Food Protection Plan.
Highlights of the agency's summary include: steps to establish FDA offices in China, India, Europe, Latin America and the Middle East; inspections of more than 5,000 high-risk domestic food establishments; and work with state and local counterparts to canvas 2,100 domestic Asian markets and remove infant formula imported from China, as well as check milk-derived products for possible melamine contamination.
Although the nonprofit consumer advocacy group Consumers Union applauded the agency's efforts to shore up the integrity of imported foods by establishing offices in regions that export to the U.S., it was critical of the agency's handling of the recent discovery of trace amounts of melamine in infant formula.
Last month, an FDA analysis of domestically manufactured infant formula revealed “extremely low levels of melamine in one sample and extremely low levels of cyanuric acid in another.” The FDA concluded that the levels were so low that they do not pose a health risk to infants.
Consumers Union is not convinced. It called for a recall of this formula, while noting that the FDA hasn't considered the consequences that could result from the combination of the two chemicals.
“The discovery that melamine is contaminating infant formula in the U.S. as well as in China indicates that much more action is needed,” said a statement issued by the Consumer Reports publisher.
Although the FDA didn't respond to Consumer Union's statement, it did tell SN that it wants to assure parents that the domestic supply of infant formula is safe. Its website reads: “There is too much uncertainty to set a level [of melamine and melamine compounds] in infant formula and rule out any health concern. However, it is important to understand this does not mean that any exposure to any detectable level of melamine and melamine-related compounds in formula will result in harm to infants.”
During the year since the FDA set forth its strategy that takes a risk-based approach to preventing foodborne contamination, intervening at critical points in the food supply chain and responding rapidly to both deliberate and unintentional contamination, the agency has focused its resources on areas posing the greatest threat.
The development of methods to detect melamine and cyanuric acid in feed (including dog food) and feed ingredients, and the approval of the use of irradiation on iceberg lettuce and spinach for the control of pathogens, have been among its efforts.
The Food Marketing Institute deemed actions like these steps in the right direction.
“FDA's announcement marks important progress toward protecting the safety of domestic and imported foods,” said Leslie Sarasin, president and chief executive officer of FMI, Washington. “FMI will continue to work closely with the government and our industry partners to ensure that Americans continue to have the most safe, affordable and abundant food supply in the world.”
The FDA's progress report comes at the end of a year of increased scrutiny for the agency.
Earlier this year, the U.S. Government Accountability Office concluded that the “FDA's oversight and enforcement efforts have not kept pace with the growing number of food firms.”
Last December, an FDA subcommittee report went so far as to say that American lives were at risk.
In June, the FDA asked for an additional $275 million above its original fiscal year 2009 request. Later that month, President Bush signed the 2008 Supplemental Appropriation into law, providing an additional $150 million for the FDA, including $72 million for food protection. The funds can be spent through September 2009.
The FDA continues to seek additional legislative authority to carry out its Food Protection Plan.
In order to strengthen its ability to ensure the safety of food, it's seeking the authority to refuse admission of imported food if FDA inspection is delayed, limited or denied; the power to issue additional preventive controls for certain high-risk foods; and the ability to gain enhanced access to food records during emergencies.
Progress made under the U.S. Food and Drug Administration's Food Protection Plan includes:
- The FDA released the CARVER self-assessment tool for industry, to minimize the risk of intentional contamination of food.
- The agency is hiring an international notification coordinator to manage enhanced information exchanges between the FDA and its foreign counterparts in regulatory authority.
- The FDA has developed a rapid-detection method that uses flow cytometry to identify E. coli and salmonella in food. It's currently in use in poultry processing facilities to detect and prevent bacterial contamination during food processing.
- The FDA has authored tools to track emergency response resources.
- The agency has signed cooperative agreements with six states to form a rapid response team to develop, implement and integrate an all-hazards response capability for food contamination and foodborne illnesses.