Food safety

The Food and Drug Administration warned Monday that the explosion of products, manufacturers and countries involved in FDA-regulated markets has created a "perfect storm" for the agency and called for a "dramatic change in strategy."

To ensure the safety of both foreign-made final products as well as the imported materials and ingredients U.S. manufacturers rely on, the FDA unveiled a "Pathway to Global Product Safety and Quality."  It focuses on four key elements: 

• Promoting international partnerships to create global coalitions of regulators;

• Sharing data and regulatory resources across world markets;

• Focusing on risk analytics and information technology; and 

• Leveraging the efforts of the public and private sectors and allocating FDA resources based on risk. Read more...

Four senators — three Democrats and a Republican — have introduced legislation that would restrict the use of antibiotics in animal agriculture.

The bill is a companion measure to legislation introduced earlier in the House by Rep. Louise Slaughter (D-N.Y.). It would ban farmers from using seven classes of antibiotics critical for human health to treat sick animals.

The bill comes as the House on Wednesday repealed a provision of the 2012 agriculture spending bill that aimed to prevent the Food and Drug Administration from similarly restricting antibiotic use in livestock and poultry. The amendment, from Rep. Denny Rehberg (R-Mont.), drew concerns from Energy and Commerce Chair Fred Upton (R-Mich.) because of its wide-ranging policy implications.

"Congressman Rehberg has been working with Chairman Upton to highlight his concerns about FDA's burdensome and unscientific regulations on Montana's ag community while avoiding any unintended consequences that could come through the appropriations process," Rehberg spokesman Jed Link told The Hill.

The House over the next two days is expected to hear successful points of order against four controversial sections of the FY 2012 agriculture appropriations bill that key House Republicans believe violate the House rule against legislating on an appropriations bill.

These provisions, already embedded in the bill, are expected to be stripped through points of order even though three of the four were put forward by Republicans during committee work.

The first of the four sections at issue has been the most controversial, as it represents a Republican attempt to limit Food and Drug Administration (FDA) regulations. Section 740 would prevent funding in the bill from being used to enforce FDA regulations unless they are based on "hard science."

The Obama administration strongly opposes an amendment to the House FDA appropriations bill that would require agencies to use "hard science" when regulating.

A global vaccine charity raised $4.3 billion to carry out its immunization plans through 2015, The Wall Street Journal reports.

People are dying because they're spending too much time in ambulances diverted from crowded emergency rooms, says a new study in the Journal of the American Medical Association.

Personal injury attorney Bill Marler threatens to sue if food safety regulators don't classify E. coli strains as adulterants.

HHS Secretary Kathleen Sebelius applauds Blue Cross of California's decision to limit profits.

Summer nutrition programs for low-income children are falling way short, says the Food Research and Action Center.

Rep. Jean Schmidt (R-Ohio) is the latest lawmaker to criticize proposed school nutrition guidelines.

The VA failed to report to its Inspector General two-thirds of rape allegations at its facilities, the Government Accountability Office alleges.

The top regulator in charge of putting in place the new food-safety law said Tuesday that a Republican-sponsored amendment to the Food and Drug Administration's budget would curtail the agency's ability to protect the public health.

The amendment cleared the House Appropriations Committee last week on a 29-20 vote. Introduced by Rep. Denny Rehberg (Mont.), it prohibits funding for FDA regulatory activity unless it is based on "hard science" and a cost-benefit analysis.

"Public health is all about prevention," said Michael Taylor, the FDA's deputy commissioner for foods. "FDA prides itself in being a science-based agency that wants to use the best available science to protect people. And legislation that would require us to wait until people are hurt in order to take action is counter, in our view, to what public health is all about.

"We deal with scientific uncertainty all the time," Taylor said. "And I think if we waited until the last science was in, I think the public would find that unacceptable because you'd be waiting until people are hurt."

A Republican amendment adopted last week by House appropriators could weaken efforts to protect the public from unsafe drugs, tobacco, lead-filled candy and even tainted blood, the Food and Drug Administration said Monday in several documents.

The amendment, from Rep. Denny Rehberg (R-Mont.), would restrict the kind of information regulators use when making their decisions. The amendment cleared the Appropriations Committee last week.

"FDA must sometimes act when there are credible risks, but before the weight of scientific evidence has been established," the FDA said in its analysis of the amendment. "This amendment would require that consumers actually be harmed before FDA can take certain actions to protect the public health."

Federal regulators reiterated Friday that they don’t believe a major E. coli outbreak in Europe is likely to spread to the U.S.

Eleven people in Germany have died in the outbreak, which is currently linked to cucumbers, lettuce and tomatoes. Officials from the Food and Drug Administration and the Centers for Disease Control and Prevention stressed that the U.S. does not import much produce from Europe and the bacteria have not been found in the U.S.

The only Americans sickened during the outbreak likely ate contaminated food while visiting Germany and simply didn’t get sick until they returned, the FDA said.

“We have no reason to believe, and no expectation, that this is going to spread in our country,” said Chris Braden, the CDC’s director of foodborne diseases.

The FDA has placed controls on German imports and is targeting its inspections at the implicated products.

After a new strain of E. coli sickened more than 1,500 in Europe, U.S. authorities moved to tighten inspections on produce. 

A coalition of consumer groups on Wednesday sued the Food and Drug Administration to force it to curtail use of antibiotics in animal agriculture.

The use of drugs to promote animal growth and prevent illnesses in poultry and livestock kept in crowded conditions is causing concerns about drug-resistant strains. The agriculture and drug lobbies say those concerns are overblown.

"Accumulating evidence shows that antibiotics are becoming less effective, while our grocery store meat is increasingly laden with drug-resistant bacteria," said Peter Lehner of the Natural Resources Defense Council, one of the plaintiffs. "The FDA needs to put the American people first by ensuring that antibiotics continue to serve their primary purpose — saving human lives by combating disease."