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US government shutdown delays release of FSMA Preventative Controls for Animal Food proposed rule

The Centers for Disease Control and Prevention (CDC) furloughed 68 percent of its staff as a result of the US government shutdown, which impacts the monitoring of foodborne illnesses and contaminants and delays indefinitely the release of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food proposed rule.

CDC had to furlough 8,754 workers, according to a tweet from agency director, Tom Frieden. Although more than 4,000 people remain at the agency during the shutdown to protect stocks of deadly viruses, like smallpox and Ebola, and run CDC's emergency operations, the agency will not be able to conduct routine inspections of high-security labs that work with "select agent" pathogens that pose severe threats to human and animal health. Most of CDC's own lab work has also been stopped.

Just one CDC staffer is tracking reports of only the most dangerous foodborne pathogens, such as Salmonella, E. coli and listeria, compared to the six staffers who usually do the work.

"We're not looking at campylobacter or shigella unless we get word from the states saying to look at this," said Christopher Braden, director of the CDC's division of foodborne, waterborne and environmental diseases.

Additionally, only seven epidemiologists are monitoring and responding to outbreaks or clusters of foodborne disease, rather than the 18 who usually handle this work, Dr. Braden said. "What we're able to do at this point is monitor and continue the investigations where we know that people are at risk. What we don't have the staff to do is address those things we normally would where there's some potential risk out there."

The US government shutdown also delays indefinitely the anticipated release of the Food and Drug Administration (FDA)'s FSMA Preventative Controls for Animal Food proposed rule. According to an update from FDA's Center for Veterinary Medicine (CVM):

"In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, agency operations will be limited to the following:
• Emergency work involving the safety of human life or the protection of property;
• Criminal law enforcement work; and
• Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act.

"With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period."

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