Food safety

After three contentious votes in the House and two in the Senate over 18 months, the real debate begins.

EPA's Jackson tells senators her agency is evaluating findings of a carcinogen in the drinking water of several cities.

House Democratic leaders are trying to drum up support for a bill that would give the Food and Drug Administration (FDA) more resources to regulate the global drug marketplace.

More and more drugs are produced overseas, presenting an “alarming” risk to consumer safety, said Democratic Reps. John Dingell, (Mich.), Henry Waxman (Calif.), Frank Pallone (N.J.) and Bart Stupak (Mich.), who sponsored the bill.

According to a joint statement, the bill:

•    creates an up-to-date registry of all drug facilities — both foreign and domestic — serving American consumers;
•    generates funding for increased Good Manufacturing Practices inspections for brand and generic drugs;
•    requires parity between foreign and domestic inspections;
•    prohibits entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections;
•    prohibits the entry of drugs into the U.S. lacking documentation of safety;
•    requires manufacturers to know their supply chain, identify and mitigate risk throughout their supply chain, and to document measures taken to secure their supply chain;
•    prohibits false or misleading reports to FDA;
•    provides strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations;
•    provides protection for whistleblowers that bring attention to important safety information; and
•    requires unique identification numbers for drug establishments and importers to improve the ability of the FDA to more quickly identify parties involved in a crisis situation.

The legislation is a high priority for Reid and Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin (D-Iowa).

Democrats may try to add the bill to a measure funding the government, but GOP says it is dead.

While a bill to overhaul the nation’s food-safety system is still in limbo, a new Centers for Disease Control and Prevention report said that one in six Americans get sick from foodborne illnesses each year.

Further, nearly 128,000 are hospitalized and 3,000 die each year, according to the CDC report released Wednesday. CDC said the report is the first comprehensive look at food illnesses since 1999.

Although the new numbers are lower than 1999 estimates, the CDC said they are more accurate. However, the numbers included a fair amount of uncertainty — unspecified agents accounted for 38 million of 48 million illnesses annually, while the remaining illnesses are due to 31 known foodborne pathogens. 

Proponents of the food-safety overhaul said the new CDC report highlights the need for the FDA Food Safety Modernization Act, which is in the Senate's omnibus spending bill.

“If we do not act quickly to modernize our food safety system, millions more Americans will fall ill due to contaminated food, and thousands more will die,” said bill sponsor Sen. Tom Harkin (D-Iowa) in a statement.

House Democrats last week tucked the food-safety bill into a continuing resolution to keep the government funded through Sept. 30, despite objections from Republicans. It narrowly passed the House, 212-206, before going to the Senate.

Some products marketed as dietary supplements have an “alarming variety” of undeclared active ingredients, according to a letter the Food and Drug Administration sent Wednesday to the drugs' manufacturers.

“These ingredients, generally undeclared in the labeling, can pose considerable dangers to consumers who may take these products without knowing that the ingredients are present, that the ingredients may be associated with serious side effects, or that they may interact in dangerous ways with other products consumers may be taking,” wrote FDA Commissioner Margaret Hamburg.

Some products marketed as dietary supplements have also been found to contain controlled substances, such as anabolic steroids, Hamburg wrote. Further, the dietary supplements are often marketed for other purposes, such as weight loss, sexual enhancement and bodybuilding.

“These products not only pose risks to consumers but undermine confidence in legitimately marketed dietary supplements in these and other categories,” Hamburg said.

The FDA has already worked with industry to recall more than 70 of these products marketed for sexual enhancement, more than 40 marketed for weight loss and more than 80 marketed for bodybuilding.

The FDA announced in the letter that it is starting an RSS feed on its website to provide more rapid alerts when the agency finds that a dietary supplement is tainted. Following the alert, the FDA will contact companies to recall the products.

House Republicans objected to the House Democrats’ insertion of the food-safety bill into the continuing resolution to fund the federal government through Sept. 30.

Rep. Frank Lucas (R-Okla.), the incoming Agriculture Committee chairman, said Democrats are resorting to legislative tricks to pass the FDA Food Safety Modernization Act.

“This is the sort of nonsense that Americans rejected just a few weeks ago,” Lucas said Wednesday afternoon on the House floor.

The food-safety bill passed the Senate last week, but a procedural error forced the House to reconsider the measure. Democrats feared that Republicans would try to stall the bill throughout the rest of the lame-duck session. Instead, on Wednesday morning, they tucked the food-safety bill into a continuing resolution to keep the government running past Dec. 18.

“[Democrats] have shut out Republicans over the past four years, and they continue to shut out common sense and the American people,” said Rep. Pete Sessions (R-Texas).

Some Republicans have objected to the bill because they said it gives too much authority to the Food and Drug Administration and creates too much of a burden on small farmers and ranchers.

The food-safety bill passed the Senate 73-25 last month before the technical glitch was discovered. A stronger version passed the House in 2009 by a vote of 283-142, but House Democrats are trying to pass the Senate version because they believe it is more politically feasible.

Rep. Jim McGovern (D-Mass.), who co-chairs the House Hunger Caucus, said he was “baffled” by the controversy over the bill, which would represent the most major changes to food-safety practices in more than 70 years.

“The fact is the food safety in this country needs to be strengthened and modernized,” McGovern said.

Senate Democrats had braced for GOP opposition and fear Sen. Tom Coburn will try to stop the measure.

The House this week will consider legislation to modernize the nation's food-safety protections, a top Democrat indicated Tuesday.

Although the Senate passed a food-safety bill last week, it contained tax provisions that, according to the Constitution, must originate in the House.  

House Majority Leader Steny Hoyer (D-Md.) told reporters Tuesday that the lower chamber this week will take up a new House bill, in hopes of sending it back to the Senate before the weekend.

Though the House last year had passed a much stronger food-safety bill pushed by liberal members of the caucus, the proposal emerging this week will more closely resemble the Senate-passed version, Hoyer indicated.

"We think that's a better bill," Hoyer said of the initial House measure, "but we're inclined to take the Senate bill, and the new bill will reflect the Senate bill."

Returning the bill to the Senate complicates the process. Not only have Senate Republicans vowed to oppose anything that hits the floor before tax cuts and government funding matters are finalized, but the second upper chamber vote allows Sen. Tom Coburn (R-Okla.) another chance to block the bill.

Last month, Coburn had forced a lengthy debate on the measure, which eventually passed easily, 73 to 25. Coburn's stalling tactics have left bill supporters wary that there's little room on the Senate calendar to accommodate the food safety vote if he repeats them.