In an April letter stemming from February inspections, the government said that T&L Trading’s live king crab and halibut had been prepared, packed or held under insanitary conditions that may have rendered them injurious to health.
A phone call to the company in Montebello, California, on Thursday morning went unanswered.
Among the alleged violations, the company wasn’t in compliance with Hazard Analysis and Critical Control Point regulations because it did not have product specifications designed to ensure fish and fishery products the company imports are not injurious to health or have not been processed under insanitary conditions, the FDA said.
The firm also did not monitor the safety of water that comes into contact with food or food-contact surfaces, the condition and cleanliness of food contact surfaces or the prevention of cross contamination with sufficient frequency to ensure compliance with good manufacturing practice requirements, the FDA said.
Results of a Food and Drug Administration investigation released last week showed the company had found 17 positive samples of Listeria on surfaces and floors in its Oklahoma plant dating back to 2013. The FDA said Friday that it “was not aware of these findings” before doing its own inspection this year.
“Although Blue Bell’s testing did identify Listeria, the company did not further identify the strain to determine if it was pathogenic,” FDA spokeswoman Lauren Sucher said.
The FDA has the authority to order a responsible party to recall a food if there is reasonable probability that the food (other than infant formula, for which FDA has separate recall authority) is adulterated or misbranded under certain provisions of the Federal Food, Drug, and Cosmetic Act, and that the use of or exposure to that food will cause serious adverse health consequences or death.
This authority for mandatory food recalls was provided by the FDA Food Safety Modernization Act to better protect public health by strengthening food safety measures and providing more effective enforcement tools. Before the enactment of FSMA in January 2011, the FDA had to rely on manufacturers to voluntarily recall food products.
In February 2015, the FDA reported to Congress that it has used this new authority twice. In both cases, the FDA issued letters to the responsible party warning that if the firm did not voluntarily cease distribution and conduct a recall, FDA may, by order, require the firm to cease distribution and give notice to other parties.
The draft guidance is in the form of questions and answers that focus on common questions that might arise about how FDA will use this mandatory recall authority. They include:
What foods are subject to FDA’s mandatory food recall authority?
What are the criteria for a mandatory recall?
What is the process FDA must follow for a mandatory recall?
The draft guidance will be available for public comment for 60 days starting May 7, 2015. The FDA will consider all comments before completing a final version.
The N.Y. Times writes in an editorial that a farsighted food safety law enacted in 2011 has faced obstacles to meaningful enforcement ever since, including delays in issuing necessary rules and a shortage of money.
Now, in what may become the latest shameful chapter, Congress seems unwilling to provide enough money to effectively carry out regulations that are about to be issued. The losers, of course, will continue to be consumers, who live with the hazards of an unsafe food supply.
The Food Safety Modernization Act was designed to prevent deadly outbreaks, not just react to them. It put the burden on food producers to make sure that their products are safe and to develop plans to prevent contamination. It also gave the F.D.A. new powers to set standards for harvesting fresh produce, recall tainted foods and monitor produce imported from abroad.
The Congressional Budget Office had estimated that the F.D.A. would need a total of $580 million from 2011-15 to carry out its reforms. That is a pittance for policing an enormous sector of the nation’s economy and barely noticeable in the vast federal budget. Yet Congress has appropriated less than half that amount — roughly $162 million — over the five-year period.
The president’s budget request for fiscal year 2016, which starts in October, asks for an appropriation of $109.5 million, an increase from $27.5 million in the current year. In addition, it calls for an increase of almost $192 million in user fees from the industry that it is virtually certain not to get. The F.D.A. in its last five budget requests proposed user fees that would cover the bulk of the costs, but Congress rejected those proposals after industry lobbying.
That’s all nice, but the industry that profits from selling food should be taking control and far exceeding government standards, as Costco and Walmart have done.
the assessment of drug concentrations in experimental diets;
experimental parameters; and
substantial evidence of effectiveness.
The draft guidance also provides recommendations for acceptable indications, as well as study designs and analyses that sponsors should use to verify the effectiveness of drugs intended to reduce pathogenic STEC in cattle.
STEC is a foodborne pathogen found mostly in cattle, but can cause serious human illness if contracted. In the U.S., E. coli O157:H7 is the most common type of STEC associated with foodborne E. coli outbreaks, but other serotypes of STEC may also cause illness in people. Most foodborne E. coli infections can be prevented by thorough hand washing, cooking meats to the appropriate temperature, and preventing cross contamination in food preparation.
The FDA is accepting public comments on this draft guidance beginning on February 24, 2015. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2015-D-0235 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close 60 days after it publishes in the Federal Register. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final guidance.
As of September 30, 2014, the FDA has received approximately 5,000 complaints of illness associated with consumption of chicken, duck, or sweet potato jerky treats, most of which involve products imported from China. The reports involve more than 5800 dogs, 25 cats, three people, and include more than 1,000 canine deaths.
These numbers include approximately 270 complaints received since the FDA’s last update in May 2014. This is a significant decrease from the previous period (October 2013 to May 2014), in which the FDA had received 1,800 complaints.
Because of the sharp reduction in complaints, the FDA is tentatively planning to shift from a biannual routine reporting cycle to issuing annual updates. This shift in reporting cycles does not mean that the FDA is reducing its effort to investigate the cause of these illnesses: the agency continues to devote significant resources to its investigation, and will post non-routine updates if notable events occur.
Although it is impossible to determine in every case whether the events reported were in fact caused by eating jerky pet treats, the FDA continues to believe that there is an association between some of the reports and consumption of jerky pet treats.
The agency continues to caution pet owners that jerky pet treats are not required for a balanced diet, and encourage them to consult with their veterinarians, both prior to feeding treats and if they notice symptoms in their pets.
In the words of Candace and Toni: If you’re not outraged, you’re not paying attention to the lies that the FDA is feeding you about the joys of raw milk.
This week, Brendan (Fred Armisen) and Michelle (Carrie Brownstein) were feeling lethargic, sluggish and generally under the weather until they discovered that raw milk is a miracle cure-all. A miracle that the FDA is trying to prevent you from enjoying! Check out this clip as they storm a doctor’s (Ed Begley Jr.) office to spread the truth about raw milk.
According to a letter sent Dec. 9 to NYWP Enterprise LLC, the FDA found numerous violations at its warehouse in McKees Rocks, Pa. between Oct. 15 and Oct. 30, including:
FDA inspectors found pests in the food plant. An apparent rodent nest was found in a plastic box containing thawing red meat.
Plumbing was not properly installed.
Rodenticides were found near food.
The warehouse failed to take proper precautions to reduce food contamination from chemicals.
The warehouse had inadequate drainage.
They did not properly store equipment and remove litter and waste.
There was inadequate workspace.
Improper storage of single-service items.
Improper lighting fixtures were found over food.
Employees were found using tobacco near food.
The list of violations was posted to the FDA’s website on Dec. 24. The company acknowledges the list of violations and said they are committed to maintaining and operating a facility that provides the highest quality service for its customers.
However, the FDA said the company did not provide proper documentation to detail how they would fix the violations.
The Food and Drug Administration (FDA), Konkan division, conducted a surprise inspection of 14 hotels and restaurants in Thane and Navi Mumbai on Wednesday night during New Year celebrations.
Nine such places came under the FDA radar that did not follow general hygiene norms. There were several complaints about the sub-standard quality of food and drinks served, owing to heavy rush.
The food safety officials collected 15 food samples, besides 13 liquor samples, in an effort to crack down on poor quality of food and drinks. The samples will be sent to Mumbai laboratory for further testing. FDA sources said that the test report was expected in a day or two, which will follow necessary action against offenders based on the Food Safety and Standards Act.
Coral Beach of The Packer writes the U.S. Food and Drug Administration has Brooklyn wholesaler New Yung Wah Trading Co. in its sights because of unresolved food safety issues that include rodents nesting in a box of thawing meat that was stored on top of fresh melons.
On Dec. 23 the FDA posted its Dec. 9 warning letter to co-owner Juan Qing Lin. FDA officials cited numerous instances of live and dead rodents, birds flying through the warehouse and landing on fresh produce and other food products during a two-week inspection of one of the company’s warehouses.
There were also plumbing problems, leaking roofs and clogged floor drains. The company had until Dec. 24 to reply to the warning letter.