- In the time frame analyzed, inspectors found significant dificiences in 1245 establishments.
- While some type of actions was taken in 78% of the inspctions, in 22% nothing was done.
- "Almost half of the warning letters were sent after the agency’s goal of four months [which is still a long time]. Twenty percent were sent after more than six months, and 2 percent were sent more than a year after the inspection."
- "The agency took an average of 6.7 months to initiate judicial action, the audit said. In one case, a seizure didn’t occur for more than a year, and an injunction didn’t occur for nearly two years."
- "Of 766 facilities that received “advisory” actions, about 1 in 5 were found to have significant violations on follow-up inspections. In about three-quarters of them, the violations were identical to those previously discovered."
The Morning Call (Allentown, PA)
http://www.mcall.com/news/watchdog/mc-nws-food-safety-inspection-problems-watchdog-20171003-story.html
Food safety oversight not well done
by Paul Muschick•Contact Reporter
The Watchdog
October 4, 2017, 8:55 PM
Don’t eat while reading this column, because what follows isn’t very appetizing.
Unless, of course, you don’t mind rainwater leaking through the roof of a food processing facility, directly above where the grub is made, and government inspectors not doing anything more than issue a warning letter, which wasn’t heeded.
Or inspectors taking no action at all when serious health risks were found. Or taking action slower than they should. Or relying on food processors to voluntarily clean up their act and not bothering to check whether they did.
That’s some of what was happening under the Food and Drug Administration’s watch of food processing facilities, according to an audit released last week.
“More needs to be done to protect our food supply,” concluded the report from the inspector general for the Department of Health and Human Services, which includes the FDA.
The FDA agreed and said it is working to implement the inspector general’s recommendations to take appropriate action against facilities with significant violations; to improve the timeliness of inspections so facilities don’t continue operating under harmful conditions; and to follow up to ensure that problems are fixed.
“The FDA recognizes the importance of its oversight of domestic food facilities, the need to ensure that resources are utilized in the most efficient way, and the importance of following up on public health concerns identified during inspections in a timely manner,” spokeswoman Lauren Sucher told me.
She said the agency’s “commitment to public health remains strong and unwavering.”
Most food products sold in the U.S., with the exception of meat, poultry and some egg products, fall under the FDA’s jurisdiction. It inspects facilities that make, process, pack and store food. The audit looked into the agency’s compliance with a 2011 law, the Food Safety Modernization Act, which required more frequent inspections and allowed for stronger penalties.
Auditors examined data from 2011 to 2015 and determined the agency was on pace to conduct the required inspections, but hadn’t made sure that all problems were corrected.
“Significant” violations were found at 1,245 facilities during that time. That often meant there were unsafe manufacturing and handling practices and unsanitary conditions, such as live birds and insects in production areas and evidence of live and dead rodents in the packaging room at a tofu plant in Washington.
Another example cited in the report was live and dead “pests” found throughout a cheese processing plant in Kentucky, where an employee was stirring cheese curds with bare hands. Neither facility was identified by name.
The FDA took “advisory” action 73 percent of the time, meaning a warning letter was sent or a meeting was held with company officials asking them to voluntarily correct the problems. Four percent of the time, the FDA pursued judicial remedies such as seizures or injunctions. Only 1 percent of the time were food products detained or operating privileges suspended.
What happened the other 22 percent of the time? Nothing. No action was taken, drawing a rebuke from the inspector general.
“If FDA takes no action in such cases, facilities may not correct the violations; this undermines FDA’s efforts to ensure that the food supply is safe,” the audit said.
When the agency took action, it sometimes took a long time to do it.
Food safety oversight not well done
by Paul Muschick•Contact Reporter
The Watchdog
October 4, 2017, 8:55 PM
Don’t eat while reading this column, because what follows isn’t very appetizing.
Unless, of course, you don’t mind rainwater leaking through the roof of a food processing facility, directly above where the grub is made, and government inspectors not doing anything more than issue a warning letter, which wasn’t heeded.
Or inspectors taking no action at all when serious health risks were found. Or taking action slower than they should. Or relying on food processors to voluntarily clean up their act and not bothering to check whether they did.
That’s some of what was happening under the Food and Drug Administration’s watch of food processing facilities, according to an audit released last week.
“More needs to be done to protect our food supply,” concluded the report from the inspector general for the Department of Health and Human Services, which includes the FDA.
The FDA agreed and said it is working to implement the inspector general’s recommendations to take appropriate action against facilities with significant violations; to improve the timeliness of inspections so facilities don’t continue operating under harmful conditions; and to follow up to ensure that problems are fixed.
“The FDA recognizes the importance of its oversight of domestic food facilities, the need to ensure that resources are utilized in the most efficient way, and the importance of following up on public health concerns identified during inspections in a timely manner,” spokeswoman Lauren Sucher told me.
She said the agency’s “commitment to public health remains strong and unwavering.”
Most food products sold in the U.S., with the exception of meat, poultry and some egg products, fall under the FDA’s jurisdiction. It inspects facilities that make, process, pack and store food. The audit looked into the agency’s compliance with a 2011 law, the Food Safety Modernization Act, which required more frequent inspections and allowed for stronger penalties.
Auditors examined data from 2011 to 2015 and determined the agency was on pace to conduct the required inspections, but hadn’t made sure that all problems were corrected.
“Significant” violations were found at 1,245 facilities during that time. That often meant there were unsafe manufacturing and handling practices and unsanitary conditions, such as live birds and insects in production areas and evidence of live and dead rodents in the packaging room at a tofu plant in Washington.
Another example cited in the report was live and dead “pests” found throughout a cheese processing plant in Kentucky, where an employee was stirring cheese curds with bare hands. Neither facility was identified by name.
The FDA took “advisory” action 73 percent of the time, meaning a warning letter was sent or a meeting was held with company officials asking them to voluntarily correct the problems. Four percent of the time, the FDA pursued judicial remedies such as seizures or injunctions. Only 1 percent of the time were food products detained or operating privileges suspended.
What happened the other 22 percent of the time? Nothing. No action was taken, drawing a rebuke from the inspector general.
“If FDA takes no action in such cases, facilities may not correct the violations; this undermines FDA’s efforts to ensure that the food supply is safe,” the audit said.
When the agency took action, it sometimes took a long time to do it.
Almost half of the warning letters were sent after the agency’s goal of four months. Twenty percent were sent after more than six months, and 2 percent were sent more than a year after the inspection.
The agency took an average of 6.7 months to initiate judicial action, the audit said. In one case, a seizure didn’t occur for more than a year, and an injunction didn’t occur for nearly two years.
Delays in seeking compliance can allow food plants to continue operating “under conditions that are harmful to public health,” said the audit, which acknowledged some actions can be delayed by legal disputes.
The FDA’s efforts to get facilities to voluntarily comply with food safety regulations didn’t always work. At the plant where rainwater was leaking through the roof, inspectors found a type of listeria that can cause life-threatening illness. A warning letter was issued, but violations went uncorrected for two years. Unsanitary conditions continued to be found in follow-up inspections, including listeria, the audit said.
The agency took an average of 6.7 months to initiate judicial action, the audit said. In one case, a seizure didn’t occur for more than a year, and an injunction didn’t occur for nearly two years.
Delays in seeking compliance can allow food plants to continue operating “under conditions that are harmful to public health,” said the audit, which acknowledged some actions can be delayed by legal disputes.
The FDA’s efforts to get facilities to voluntarily comply with food safety regulations didn’t always work. At the plant where rainwater was leaking through the roof, inspectors found a type of listeria that can cause life-threatening illness. A warning letter was issued, but violations went uncorrected for two years. Unsanitary conditions continued to be found in follow-up inspections, including listeria, the audit said.
That situation wasn’t unique. Of 766 facilities that received “advisory” actions, about 1 in 5 were found to have significant violations on follow-up inspections. In about three-quarters of them, the violations were identical to those previously discovered.
That may be happening even more often, but the FDA wouldn’t know it because timely follow-up inspections weren’t done about half the time, according to the audit. Seventeen percent of the time, there was no follow-up inspection at all.
“If FDA does not ensure that significant inspection violations are corrected in a timely manner, it is unable to guarantee that these facilities are not producing and distributing food that is harmful to the public,” the report said.
Lisa Rovin, an FDA deputy associate commissioner, said in a written response to the audit that the agency “agrees that there are challenges” in its inspections. She said the FDA recently developed a reporting system to more efficiently track compliance activities.
Regarding the late warning letters, she said more than 65 percent of those issued beyond six months involved dietary supplement facilities, a rapidly expanding industry that is receiving more attention since 2015 through an internal restructuring.
The Watchdog is published Thursdays and Sundays. Contact me at watchdog@mcall.com, 610-841-2364 or The Morning Call, 101 N. Sixth St., Allentown, PA, 18101. I’m on Twitter @mcwatchdog and Facebook at Morning Call Watchdog.
That may be happening even more often, but the FDA wouldn’t know it because timely follow-up inspections weren’t done about half the time, according to the audit. Seventeen percent of the time, there was no follow-up inspection at all.
“If FDA does not ensure that significant inspection violations are corrected in a timely manner, it is unable to guarantee that these facilities are not producing and distributing food that is harmful to the public,” the report said.
Lisa Rovin, an FDA deputy associate commissioner, said in a written response to the audit that the agency “agrees that there are challenges” in its inspections. She said the FDA recently developed a reporting system to more efficiently track compliance activities.
Regarding the late warning letters, she said more than 65 percent of those issued beyond six months involved dietary supplement facilities, a rapidly expanding industry that is receiving more attention since 2015 through an internal restructuring.
The Watchdog is published Thursdays and Sundays. Contact me at watchdog@mcall.com, 610-841-2364 or The Morning Call, 101 N. Sixth St., Allentown, PA, 18101. I’m on Twitter @mcwatchdog and Facebook at Morning Call Watchdog.
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