Nerd alert: US FDA releases supplement to the 2013 Food Code

The U.S. Food and Drug Administration has issued the Supplement to the 2013 Food Code. The update addresses recommendations made by regulatory officials, industry, academia, and consumers at the 2014 Biennial Meeting of the Conference for Food Protection. Food Code and its Supplement provide government and industry with practical, science-based controls for reducing the risk of foodborne illness in retail and foodservice establishments of all types. The Food Code and the Supplement are joint projects of the FDA, Centers for Disease Control and Prevention, and the United States Department of Agriculture – Food Safety Inspection Service.

The Supplement modifies the 2013 Food Code to:

Expand the duties of the Person in Charge in a food establishment to include overseeing the routine monitoring of food temperatures during hot and cold holding.

Expand and clarify the type of information that should be included when a Hazard Analysis and Critical Control Point Plan is required by a regulatory authority.

Emphasize that cleaning and sanitizing agents should be provided and available for use during all hours of operation.

Clarify the difference between Typhoid Fever and nontyphoidal Salmonellosis with regard to the reporting of illness and the exclusion and restriction of ill food employees.

Suggest that regulatory authorities ensure that inspection staff has access to the necessary training and continuing education.

The Food Code is the model for retail food regulations in all 50 states, the District of Columbia and Puerto Rico. The FDA encourages its state, local, tribal, and territorial partners to adopt the latest version of the FDA Food Code, including the Supplement to the 2013 Food Code.

FDA’s National Retail Food Team assists regulatory officials, educators, and industry in their efforts to understand, adopt, and implement, the FDA Food Code. Inquiries may be sent to: or directly to a Regional Retail Food Specialist.

The 2013 FDA Food Code and its Supplement is available on the FDA website at 



Didn’t pay attention to the safety: Blue Bell, FDA had Listeria warning signs at Alabama plant years ago

On the heels of reaching a deal with Alabama state health officials to boost testing and other safety measures, federal reports show Blue Bell Creameries was also warned of leaks and hygiene issues at its facilities in that state as far back as 2011.

blue.bell.creameriesOver the course of at least a half dozen visits by Alabama state health department inspectors dating back to 2010, reports show that the Blue Bell facility in Sylacauga, Ala., saw issues also seen at its plants in Broken Arrow, Okla., and Brenham, where the company is based. The reports were obtained by the American-Statesman as part of an open records request.

The U.S. Food and Drug Administration, however, did not follow up directly at that plant until this year when reports revealed listeria-related concerns for Blue Bell’s products.

Blue Bell Creameries responded Tuesday afternoon to the federal and state inspection reports, saying the company takes inspections seriously and is currently conducting a thorough review of their operations.

On Monday, Blue Bell struck a deal with Alabama state health officials like ones it had brokered two weeks ago in Texas and Oklahoma to step up testing and safety measures when production resumes. The agreement with the state of Alabama also says there will be a trial production period before products are shipped to consumers.

Company warned to get its HACCP together for eel

The U.S. Food and Drug Administration issued a warning letter to seafood processing company Saemus on May 18 over what it called “serious” Hazard Analysis and Critical Control Point (HACCP) violations.

eelThe determination is based on inspection of the processing facility in Virginia from Oct. 29 through Nov. 5 of last year, the letter said.

Among concerns was that the firm does not have a HACCP plan in place for its frozen vacuum packed, cooked, ready to eat eel.

Also, its ready-to-eat broiled eel kabayaki and hot and spicy eel productslacked the required HACCP plan to assure the fish are cooked sufficiently.

It also found a product — Natural Fresh Water Eel — was misbranded, since the label fails to declare all major food allergens present in the product.

FDA alleges California crab, halibut importer violated food safety rules

The U.S. Food and Drug Administration has issued a warning letter to a California seafood firm, alleging violations of food safety rules.

Mr-Krabs-SpongeBob-SquarePants-300x214In 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.

Increased inspections mean little: FDA unaware of Listeria in Blue Bell plant before outbreak

I’ve always told my daughters, whenever someone says, “trust me,” immediately do not trust them.

Do-Not-Trust-MeTrust is earned by actions, not words.

Amidst reports that Listeria-contaminated Blue Bell ice cream is selling well on Craiglist and other Internet markets, U.S. Food and Drug Administration types said they were never told of repeated findings of Listeria at a Blue Bell Creameries facility before an outbreak linked to the ice cream turned deadly.

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.

Which is why all test results should be public.


Going public (sort of?): FDA issues draft guidance on mandatory food recalls for comment

The U.S. Food and Drug Administration has published a notice in the Federal Register that a draft guidance for industry on mandatory food recalls is available for public comment.

communicationThe 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.

For More Information:

Money where your mouth is: A shortage of funds for US food safety

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.

restaurant.inspectionNow, 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.

Draft guidance to help evaluate effectiveness of drugs to reduce pathogenic Shiga toxin-producing E. coli in cattle

The U.S. Food and Drug Administration issued today draft Guidance for Industry #229: Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli (STEC) in Cattle. GFI #229 provides recommendations on study design and criteria drug manufacturers should use when evaluating the effectiveness of animal drugs intended to reduce STEC. The draft guidance addresses topics including:

supershedder.e.coliprotocol development;

study conduct;

animal welfare;

nutritional content of experimental diets;

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 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.


Almost 6000 sick with 1000 dead dogs: Jerky pet treat investigation in US

The U.S. Food and Drug Administration has issued an update on its ongoing investigation into pet illnesses and deaths in animals that ate jerky pet treats. 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.

Portlandia gets raw as they expose the FDA’s lies (it’s satire)

Things are about to get raw on Portlandia.

Fred Armisen, Carrie Brownstein- Photo Credit: Augusta Quirk/IFCIn 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.