Mar 25, 2013
FDA food safety laws weakened by rarely disclosed OMB changes
US Food and Drug Administration (FDA) food safety documents showing changes made by the Office of Management and Budget (OMB) prove that OMB "stripped product and environmental testing requirements, among other provisions that FDA sought, from the preventive controls rule," says a story today in Food Safety News (FSN). The track-change documents were posted online last week by the Department of Health and Human Services and reported by Food and Chemical News Thursday. Called Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, the rules comprise the preventive controls proposed by FDA in November 2011 that would have required environmental and finished product testing by food companies, maintenance of supplier verification programs, and consumer complaint tracking as means to quickly identify foodborne pathogens before they enter the food supply. It is
standard for regulations that are economically significant to go through OMB review, but specific changes made there are generally not disclosed. The tracked documents show that OMB struck the requirements and also extended the time to compliance for farms and small and large businesses. Said David Plunkett, senior food safety attorney for the Center for Science in the Public Interest, "It's OMB once again protecting corporate bottom lines at the expense of protection for public health. Testing is critical to verification."
Mar 25 FSN story
Mar 21 Food and Chemical News preview
OMB-edited FDA documents, posted Feb 27
Summer furloughs of meat inspectors off the burner
The threatened 11 furlough days for federal meat and poultry inspectors this summer because of the sequester have been squelched by Congress after the House passed a resolution Mar 21 by a vote of 318 to 109 to approve the reallocation of $55 million in funds from other parts of the US Department of Agriculture (USDA) to its Food Safety and Inspection Service, according to a Mar 22 FSN story. This followed Senate passage of the resolution the day before by a vote of 73 to 26; the legislation now goes to President Obama for his signature. Beef, poultry, and pork plants can operate only if a federal inspector is present, so the plants would have had to shut down on the furlough days, putting an estimated 500,000 workers at 60,000 plants out of work for the 2 weeks' worth of days, costing nearly $400 million in wages, the story says.
Mar 22 FSN article
Mar
14 CIDRAP News item on the furlough
Feb 14 CIDRAP News item on the furlough
First botulinum antitoxin approved by FDA, will go in stockpile
Botulinum toxin, which formerly was untreatable, can now be neutralized. With FDA approval on Mar 22, the life-threatening disease can be treated, and a countermeasure to the potential use of the toxin as a bioterror weapon is now available. Called Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine), the new agent is capable of neutralizing all seven of the known serotypes of botulinum. The effectiveness of the product, which is derived from horse plasma, was studied in animals because human testing was not feasible or ethical, says a Mar 22 FDA news release. Safety was tested in 40 human volunteers and monitored in an additional 228 patients. The FDA Animal Rule allows approval of a biological product if well-controlled studies in animals show it likely to be effective in humans and if safety in humans has been established; the botulism antitoxin is the first plasma derivative approved using the Animal Rule,
according to the release. The most common side effects of the agent in the human subjects were headache, fever, chills, rash, itching, and nausea, and people sensitive to horse proteins may have allergic reactions. The antitoxin, manufactured by Cangene Corporation in Winnipeg, will be maintained in the Strategic National Stockpile.
Mar 22 FDA news release
