Food Safety News
According to FDA, the Food Defense Plan Builder, available online, is a “comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.”
As the agency noted this week in its release, FDA does not require food facilities to implement food defense plans, but many companies voluntarily craft plans and put them in place at their own facilities.
“The FDA is committed to providing best practices and resources to support industry as we pursue our shared goal of protecting our food supply,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor, in a press release. “We strongly encourage companies to take full advantage of the Food Defense Plan Builder.”
More from FDA:
“Cases of intentional contamination are infrequent but can entail serious adverse public health consequences. For example, in 2009, more than 40 people in Kansas became ill after disgruntled restaurant employees intentionally contaminated salsa with a pesticide. In 1996, 12 lab workers at a Texas medical facility became ill after eating pastries that were intentionally contaminated with a virulent strain of Shigella bacteria.
The Food Defense Plan Builder is FDA’s latest effort to help owners and operators of food facilities take appropriate action to defend the food supply. In the years following the September 11, 2001 attacks, the FDA released a number of food defense tools and resources to aid the U.S. food industry, federal partners, state and local regulators, and the international community in protecting the food supply against biological, chemical and radiological attack.
The Food Defense Plan Builder guides users through a series of substantive questions about the user’s food facility and the food manufactured, processed, packed or held there to develop a comprehensive food defense plan for the facility, which includes a vulnerability assessment, broad and focused mitigation strategies, and an action plan.
The content in the tool is based on the FDA’s food defense guidance documents and as such, the Food Defense Plan Builder is consistent with the FDA’s current thinking on food defense preparedness. In addition to providing new functionality for food defense planning and implementation, the Food Defense Plan Builder harnesses existing FDA tools and resources into a single application. These tools and resources include the FDA’s food defense guidance documents, Vulnerability Assessment Software Tool, and Mitigation Strategies Database.”
The veto by Tennessee Republican Gov. Bill Haslam of a bill requiring anyone taking pictures or shooting video of animal abuse to turn the evidence over to law enforcement within 48 hours may have national impact.
Haslam’s veto, coming on the heels of an opinion by his democratic Attorney General that the so-called “ag-gag” measures are “constitutionally suspect,” could be a turning point. Tennessee Attorney General Bob Cooper said SB 1248/HB 1191 possibly violates the First and Fifth Amendments to the U.S. Constitution for placing burdens on the news media and violating the right against self-incrimination.
In addition to sharing Cooper’s concerns, Haslam said the bill passed by the Tennessee Legislature appears to repeal parts of the state’s Shield Law, which exists to protest journalists from being used by law enforcement. And, Haslam said, some of the state’s district attorneys are concerned that the law actually makes it more difficult to prosecute animal abuse.
Differing views on when animal abuse should be reported was at the heart of the Tennessee debate. The most significant animal abuse cases are often the product of undercover investigations by animal activists. They say those investigations usually take several weeks, and would be harmed by premature presentations to law enforcement. Animal agriculture wants quick reporting, arguing that animal abuse should not be stretched out for the sake of making a better case.
“Ag-gag” laws would put undercover investigators out of business, according to groups like the Humane Society of the United States (HSUS). After Tennessee’s “ag-gag” bill passed, campaigns broke out to persuade Haslam to both sign and veto it. Veto advocates were able to remind state voters of a recent undercover investigation conducted by HSUS in the state.
Multiple state and federal indictments followed HSUS’s investigation into Tennessee walking horse trainer Jackie McConnell’s stable in Collierville in 2011. The group’s undercover investigator collected recordings of horses being whipped, kicked and shocked in the face. McConnell and two others were charged with multiple counts of animal cruelty. Had the vetoed law been in effect, HSUS said the cruelty to horses would never come to light.
Six states have adopted “ag-gag” laws. Iowa, Utah, and Missouri passed such legislation last year. Kansas, Montana and North Dakota did so back in 1990-91. No one can find much in the way of prosecutions under these laws, but that could be because animal welfare groups might be less active in those six states.
This year, “ag-gag” bills have fallen short. Wyoming adjourned before there could be a vote in the second house. Indiana’s chambers could not agree after passing differing versions. The bill’s California sponsor dropped it in that state. And now Tennessee’s bill died in a gubernatorial veto.
State legislatures are quickly shutting down for the year. Of the 50, 20 have already adjourned sine die. Many others will do so before June. A couple that meet into the summer, such as Nebraska and Pennsylvania, could still pass another “ag-gag” this year.
But the Tennessee veto makes that less likely than it was before the Haslam veto.
Photo of Gov. Haslam courtesy of the Southern Governors Association.
Levels of inorganic arsenic found in samples of chicken may be responsible for a slight increase in cancer risk to consumers over their lifetimes, according to a study by researchers at John Hopkins University published this week.
That research comes on the heels of a lawsuit filed against the U.S. Food and Drug Administration two weeks ago by the Center for Food Safety and eight other government watchdog organizations which demands that the FDA respond to a three-year-old petition to disallow compounds containing arsenic from food animal feed.
The samples of chicken in the John Hopkins study were collected in 2010 and 2011, just before Pfizer, the manufacturer of 3-Nitro (also known as roxarsone), an antibiotic containing arsenic, suspended sales of the product in summer 2011.
Roxarsone had been given to feed animals to kill intestinal parasites and promote growth since the 1940s, though only recently did researchers find evidence that the harmless, organic arsenic in the drug could turn into carcinogenic, inorganic arsenic in meat. One other arsenic-containing drug, nitarsone, is still on the market.
In 2011, the FDA’s Center for Veterinary Medicine concluded that the safe level of inorganic arsenic in chicken meat stood at 1 part per billion (ppb). The agency later revised that statement to say that any level of inorganic arsenic was concerning.
The John Hopkins study analyzed samples of conventionally raised chickens that were fed antibiotics, antibiotic-free chickens, and organically raised chickens. Meat from those chickens raised with antibiotics had more than twice the amount of inorganic arsenic (1.8 ppb) compared with the antibiotic-free (0.7 ppb) and organic (0.6 ppb) chickens.
Speaking to the New York Times, a spokeswoman for the National Chicken Council called those arsenic levels “very low” and noted that they reflected levels from before roxarsone was removed from the marketplace.
Researchers found roxarsone in 20 out of the 40 samples of antibiotic-raised chickens, 1 out of 13 of the antibiotic free samples, and none of the 25 organic samples. Meat from chickens given roxarsone was found to contain arsenic at 2.3 ppb, while meat from roxarsone-free chickens contained arsenic, on average, at 0.8 ppb.
That dosage of inorganic arsenic, the researchers determined, might result in an additional 3.7 cases of bladder and lung cancer for every 100,000 people eating chicken.
Though Pfizer voluntarily suspended roxarsone sales, the FDA has not banned the product for use in feed animals. The company told the Times that it had no plans to reintroduce the drug.
The coalition of watchdog groups led by the Center for Food Safety still wants FDA to place an outright ban on arsenic-based drugs.
“FDA could easily and immediately fix the problem, but instead puts its head in the sand,” said Paige Tomaselli, senior staff attorney with the Center for Food Safety in a press release. “We can only conclude the FDA is catering to the companies that continue to sell products containing arsenic that ends up in our food supply.”
In 2012, Maryland became the first state to ban arsenic-based drugs for feed animals.
The John Hopkins study on inorganic arsenic levels in chicken meat can be accessed here.
Nearly two years after Consumer Reports and Dr. Oz sparked national concern after finding arsenic in popular brands of children’s apple juice, a handful of Democrats in the House and Senate are asking the White House Office of Management and Budget to release a long-delayed voluntary guidance on limiting arsenic, a known carcinogen, in juice products.
The recent letters from lawmakers, which argue that delays on such issues have a negative impact on public health, come right as OMB is going through a major leadership transition. Syliva Mathews Burwell was recently confirmed by the Senate as the new director, taking over for Jeffrey Zients, a deputy director who had been acting director for the past year. Zients, who the administration had dubbed the nation’s first “chief performance officer,” left OMB last week and the agency’s Office of Information and Regulatory Affairs – the increasingly powerful entity that oversees the review of economically significant regulations – will also soon have a new head. In late April, President Obama nominated Federal Trade Commission economist and law professor Howard Shelanski, who is awaiting Senate confirmation.
Amid these changes, Democrats are expressing frustrations about dozens of delayed regulations, whether they be environment, worker safety, or food-related.
“I’m writing OMB to remind the agency that there are human costs to delay,” Senator Richard Blumenthal (D-CT), chair of a key judiciary subcommittee, wrote in a letter sent to OMB last week. “Parents should not have to worry about whether the juice they give their child has arsenic in it, and workers should not have to risk contracting lung disease while on the job. Rules and guidelines that could prevent both of these problems have been moved from the back burner to the deep freeze at OMB.”
Blumenthal noted that 84 of the 153 regulatory actions under review at OIRA have been there for more than 90 days, which is supposed to be the limit for review. For example, Blumenthal pointed to a rule meant to protect workers from inhaling silica dust, submitted by the Occupational Safety and Health Administration, that has now been “sitting before [OIRA]” for more than two years.
“Given the health and safety implications of these agency actions, the length of delay in OIRA’s review is unacceptable,” wrote Blumenthal.
The senator is asking OMB to immediately complete its review of languishing regulations and return them to the agencies so they can move forward. “Otherwise, I would like you to please explain in writing the reasons for delay, and propose an alternate timeline for completion of OIRA’s review process.”
In a separate letter to OMB, Reps. Rosa DeLauro (D-CT) and Frank Pallone (D-NJ) last week urged the administration to make progress on limiting arsenic in juice. DeLauro and Pallone have sponsored legislation that would mandate enforceable standards for heavy metals like arsenic in food products, similar to what the government already has in place for drinking water and bottled water.
“We believe that while FDA should implement enforceable standards for the maximum allowable levels of arsenic in rice and juice, the Agency’s guidance document on arsenic in juice is an important first step that will inform and educate industry and consumers,” state DeLauro and Pallone in the letter. “We applaud FDA for its efforts to address the issue and develop new guidelines to reduce the risk posed by arsenic in apple juice. It is inexcusable that these guidelines are stalled while consumers continue to be exposed to potentially dangerous levels of arsenic.” (The lawmakers were likely referring to FDA’s 2011 testing of apple juice products and the agency’s consideration of a standard for arsenic in juice).
FDA says it remains confident in the overall safety of the nation’s apple juice, because the vast majority of products tested contain “low amounts” of inorganic arsenic, which is a health concern. But testing by Consumer Reports, FDA, Dr. Oz and others have found that some products contained levels of arsenic well above the standards set for drinking water.
“We want to minimize the public’s exposure to arsenic in foods as much as we can,” FDA’s Deputy Commissioner for Foods and Veterinary Medicine Micahel Taylor in a 2011 consumer update, which added: “For that reason, FDA plans to consider all the relevant evidence and, based on this work, FDA may set a guidance or other maximum level to further reduce arsenic in apple juice and juice products.”
The agency has drafted a risk assessment and draft action levels for arsenic in juice, but, according to a January Food Chemical News report, clearance by OMB is taking longer than FDA expected.
So what, exactly, is the status of those draft guidelines today? Presumably, the documents submitted by FDA remain under review at OMB, but the White House agency did not respond to inquiries from Food Safety News. A spokesman for the FDA was unable to answer questions about when the agency submitted guidance documents to OMB or discuss anything related to the status of the process.
“Given the attention the agency has paid to this important issue, we think the OMB should release the guidance so that the juice industry can move forward to provide consumers with better assurances that the levels of arsenic in juice will at least be monitored,” said Urvashi Rangan, director of safety and sustainability at Consumer Reports. ”We have standards for arsenic bottled water, there is no understandable reason we don’t have those (or guidances) for food and beverages.”
Take a moment to consider some of the foods found in a supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and processes that food went through to get all the way to those shelves.
While the ice cream likely went through more processes than, say, the tomatoes, most food items found in a supermarket likely underwent a multitude of steps and passed through several hands before ultimately reaching their destination. The decision of food suppliers to record those steps could make a significant difference in the impact those products have on public health in the event of an outbreak or recall.
But when it comes to food, the variety of traceability systems in the marketplace nearly parallels the number of ingredients in a pint of that chocolate chip peppermint brownie ice cream. Not only do most competitors use different systems and technology, most firms along the same supply chain — from farm to processing plant to retailer — record and translate their data in different ways.
Picture a pile of tomatoes in the produce section. Farms supply tomatoes to a distributor, who gives them a product code before passing them onto a retailer who may give them a different identifying code. Go find a can of diced tomatoes in another aisle and the number of changed hands and identification codes may have doubled. Find a jar of salsa — the ingredients, codes and suppliers compound exponentially.
Now, throw a Salmonella outbreak into the mix. Hundreds of people around the country report illnesses and face interviews with investigators asking them to recall several weeks of meal histories.
At first, interviews seem to point to tomatoes as the most likely source — maybe a lot of the victims ate salsa — and so investigators begin tracing back through the tomato supply chain in search of the contamination. Eventually, however, the investigation into tomatoes dries up, and it only later becomes apparent that the outbreak was instead likely caused by contaminated jalapeño peppers.
That’s what happened across 43 states in the spring of 2008, and while investigators were tracing back through tomato supply chains, the jalapeños were granted more time to sicken additional consumers, according to Christopher Waldrop, director of the Food Policy Institute at the Consumer Federation of America. Investigators might have ruled out tomatoes and moved on to jalapeños faster if suppliers had implemented better functioning traceability systems, saving more people from illness, Waldrop said.
“If you work quickly, you can save lives,” said Jennifer McEntire, Ph.D., senior director of the Food and Import Safety Practice at Leavitt Partners.
McEntire served as lead author of a report published by the Institute of Food Technologists (IFT) and commissioned by the U.S. Food and Drug Administration which details pilot projects for improving tracing through the food system. That report, in part, looked at a number of well-researched outbreaks to perform a cost-benefit analysis of using traceability systems.
If the duration of tracebacks during outbreak investigations could be reduced by half — or even a quarter — through the use of effective traceability systems, the impact of outbreaks could be significantly reduced, McEntire said. The money saved on healthcare alone would have reached into millions of dollars in some of the outbreaks IFT studied — and that’s not to mention the damage caused to industry when investigations persist in the spotlight and the public loses trust in a food product.
The FDA asked IFT to compose that report to better inform rules on traceability to be proposed as part of the Food Safety Modernization Act (FSMA), signed into law in 2011. While the FDA has released detailed proposals for some rules in the FSMA, the current section on traceability is still relatively open-ended, McEntire said.
Thus far, the FDA has suggested that it will require producers of “high-risk foods” to implement traceability programs, though no one has yet established what counts as a high-risk food. Given that there are a wide variety of traceability systems available to food makers, McEntire said it is highly unlikely that the FDA would endorse any particular traceability technology.
“I assume FDA will come out with an objective-based requirement: ‘Here is what you need to be able to do. Here are the data that need to be captured. Here’s the format you need to share it in,’” McEntire said.
The first goal should be to make sure producers and distributors are working with the same information and everyone knows what information they need to have, McEntire said. Data as simple as names, locations, and lot numbers can get muddled as product switches hands on the way to the supermarket, and everyone prioritizes information differently.
One of the biggest challenges for traceability systems, both McEntire and Waldrop agreed, is that they require human input at every link in the supply chain to function effectively. But traceability can require a lot of paperwork, and data may be subject to human error — assuming companies can find the resources and interest to have someone record it in the first place.
Companies view traceability as an additional cost, McEntire said, and so few of them adopt traceability systems for the sake of having traceability in the event of an outbreak. It’s better sold as a tool to improve supply chain efficiency and accuracy.
“Traceability is best positioned as a byproduct,” McEntire said. “Companies want to have it for other reasons, like improved record-keeping, inventory purposes, a better grasp of suppliers in order to gauge quality. That’s how you build traceability — sneaking it in on the side.”
Until the FDA makes its formal proposal on FSMA traceability rules, both IFT and the Consumer Federation of America are encouraging the agency to reconsider requiring all foods to have some sort of traceability — not just those deemed “high-risk.”
That’s mainly for two reasons, Waldrop said.
First, food once thought to be low-risk could become high-risk. Cucumbers, for example, were never connected to a foodborne illness outbreak until last month. The second reason is that some producers would be making both low-risk and high-risk foods, meaning that their facilities could theoretically be operating under two different record-keeping rules.
For now, though, Waldrop expressed a hope that the FDA would soon form a more clear impression of its plans for traceability requirements.
“FDA needs to articulate its traceback information needs so that everyone has a better sense of the information they should be collecting,” Waldrop said. “If FDA could provide that, it would help push this issue along and address concerns about what information they’re collecting and not collecting.”
Chewing gum and mint giant Wrigley announced last week that it will temporarily remove its new caffeinated gum from the market after the U.S. Food and Drug Administration expressed concerns over the product’s safety.
The gum was greeted with skepticism immediately after its release late last month by FDA and consumer groups alike.
The federal food safety agency said the gum is the latest in a series of products containing added caffeine at levels beyond those FDA considered when it last evaluated the issue in the 1950s while assessing the safety of caffeine in colas.
Given the rise of added caffeine in food and drinks since that time, FDA declared its intention to reevaluate the safety of added caffeine in foods and beverages.
The agency made this announcement April 29, the same day Wrigley released its caffeinated gum, Alert, which contains 40 mg of caffeine per stick – the amount found in half a cup of coffee.
Wrigley responded to FDA’s concerns Thursday, saying it would halt production and sales of Alert.
FDA praised the move and encouraged other companies to follow Wrigley’s lead.
“The FDA applauds Wrigley’s decision and its recognition that we need to improve understanding and, as needed, strengthen the regulatory framework governing the appropriate levels and uses of caffeine in foods and beverages,” said Michael Taylor, FDA Deputy Commissioner of Health and Veterinary Medicine, in a statement Thursday.
With these words, Taylor signaled that stricter regulation of added caffeine in foods and beverages is on the horizon.
“We look forward to working with industry, the scientific and medical community, and all interested parties to address the issues posed by added caffeine in foods and beverages,” said Taylor.
Last month I wrote a news story along the lines that President Obama this spring signed House Resolution 933 after California voters last fall defeated Proposition 37 marked two big defeats for the GMO labeling crowd. HR 933 was dubbed the “Monsanto Protection Act” for its limiting federal courts from ordering genetically modified crops from being destroyed. Failed Prop 37 would have required GM foods sold in California to be labeled.
So it’s only fair that I note that GMO labeling forces are celebrating a victory of sorts. The Vermont House of Representatives on May 10, 2013 became the first legislative body in America to pass a GM food labeling bill. The historic vote was 99-to-42 on H-112, requiring the labeling of all genetically engineered food in the state.
I say it’s a victory of sorts because the GMO bill is not getting a vote in the Vermont Senate this year. If H-112 gets a Senate vote in 2014, it still does not become law until at least two other states adopt similar measures. Still, milestones are milestones. The national “Just Label It” campaign and Consumers Union, the lobbying arm of Consumer Reports, both put out press statements applauding the action by the Vermont House.
Alaska earlier this year did enact a law requiring the labeling of GE fish, which is designed to give extraordinary protection to the state’s prized salmon stocks. Washington State voters will likely also be hearing plenty about the threat of bulked-up GE salmon this fall.
In perhaps its smartest move since the Prop 37 defeat, the GM food labeling campaign did an initiative to the Legislature in Washington, which required less money spent on acquiring petition signatures and is ending up on November ballots because lawmakers opted to take no action against it.
They could have amended it, or put up their own alternative against it, but by taking no action the Initiative 522 campaign starts out on top much the way Prop 37 did in California. I guess this means that the GMO labeling issue just keeps on giving.
Before I go further, let me state for the record that I like to see the “wiring diagrams” for any and all food available to all of us. In the past, I’ve suggested we should all be supporting the contest for developing a Star Trek-style Tricorder that we could use to satisfy our curiosity.
What I haven’t been able to get all that excited about is just labeling GM food with some simple line like; “This product has been modified by genetic engineering.” If that fulfills the “right to know” mandate, I for one would be very disappointed.
If the scientific consensus is that GM foods carry no more risk to human health or the environment that their non-GMO counterparts, is this line on the label really going to mean that much? On the other hand, if, as I suspect, it’s another meaningless throw-away line on our already crowded food labels, why does the food industry care so much? (Or at least to the tune of the $45 million it spent opposing Prop 37 in California.)
The food industry’s problem is that it cannot see over the horizon. My guess is that the GM label would become another indicator, not unlike the organic label, that consumers would use to process their decisions. Sure, some might stop buying anything with a GM label, but how many? If the hops used in my favorite beer were genetically modified, I doubt if I’d care.
What consumers really want to know is more. If they find their favorite cereal is made with wheat genetically modified to grow during droughts, they probably will be happy to know without changing their purchase decision.
In other words, the food industry should pour on more information, not less. It should make transparency its friend and cease playing defense to a motley collection of activists. Consumers are hungry for more information. We in media love campaigns that never end, but the public would really like to see somebody do something useful with food information for a change.
Another three individuals have been confirmed ill with E. coli O121 after eating Farm Rich products, bringing the total number ill to 35 people in 19 states, according to the U.S. Centers for Disease Control and Prevention.
At least nine patients have been hospitalized, and 82 percent of those ill are 21 years old or younger. Two of those hospitalized developed hemolytic uremic syndrome, a kidney disease resulting from severe E. coli infections.
Farm Rich has recalled a number of products, all of which are listed here. The recalled products have best-by dates ranging from January 1, 2013 to September 29, 2014.
Consumers are encouraged to discard any recalled Farm Rich products.
The U.S. Department of Agriculture and the U.S. Food and Drug Administration are currently investigating the cause of the Farm Rich E. coli contamination.
The U.S. Food and Drug Administration is warning consumers not to drink any juice from a New York-based juice maker whose manufacturing processes do not adequately prevent its products from the growth of Clostridium botulinum.
According to FDA, carrot and beet juices from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. have the potential to be contaminated with Clostridium botulinum due to food safety insufficiencies in production.
FDA filed a complaint for permanent injunction against the company in October of 2010 after the company failed to correct continuing sanitation violations at its facility.
A judge ordered the permanent injunction in January of 2011, thus blocking the company from manufacturing or selling product until it corrected its sanitation issues.
However, Juices Incorporated failed to comply with the consent decree, prompting a Judge for the Eastern Disctrict of New York to issue an Order to Enforce Consent Decree.
Now, FDA reports that “FDA investigators recently confirmed that Juices Incorporated and its owners continue to manufacture and distribute juice products and other beverages.”
Juices from the company were recently found in New York City area retail establishments and restaurants, reports FDA.
While the company’s carrot and beet juices are the ones that pose a particular botulism risk due to the way they have been produced, FDA is also recommending that consumers avoid any products made by Juices Incorporated, including Ginger Beer Drink, Agony Peanut Punch, Front End Lifter Magnum Punch, Irish Sea Moss, Cashew Punch, Sorrel Drink, Pineapple Twist, Soursop Juice, Corn Punch and any other types of juice the company might have distributed.
The carrot and beet juices FDA says are known to pose a botulism risk include:
- Carrot Juice Drink
- Carrot & Beet Juice Drink
- Carrot & Ginger Drink
- Double Trouble Carrot Punch
- Ginger Beet Juice
- Beet Juice Drink
Salmonella Typhimurium Outbreak
The first outbreak, caused by a strain of Salmonella Typhimurium, has sickened 146 people in 26 states since early March, when the outbreak began.
Of these patients, 27 have been hospitalized, but no deaths have been caused by the bacteria. Approximately two thirds (66 percent) of the victims are children 10 years old or younger.
While epidemiological investigation have pointed to baby chickens, ducks and other live baby poultry, the source of the outbreak has yet to be determined.
In interviews, 94 percent of patients report having contact with live baby poultry in the days prior to their illnesses. A ful 97 percent of patients with available information report having purchased baby poultry from one of 13 agricultural feed store companies around the country.
The number of cases by state is as follows: Arizona (5), California (3), Colorado (16), Florida (2), Indiana (4), Iowa (2), Kansas (10), Louisiana (5), Minnesota (2), Mississippi (3), Missouri (9), Nebraska (9), Nevada (1), New Hampshire (1), New Mexico (10), New York (8), North Dakota (1), Oklahoma (9), Oregon (5), South Dakota (6), Texas (19), Utah (3), Vermont (1), Virginia (1), Washington (10) and Wyoming (1).
Salmonella Infantis and Salmonella Mbandaka Outbreaks
A second Salmonella outbreak tied to contact with live baby poultry is being caused by a strain of Salmonella Infantis and a strain of Salmonella Mbandaka, according to CDC.
A total of 61 people in 18 states have fallen ill in this outbreak since March 8 of this year. Of those sickened, 12 were hospitalized. No deaths have been linked to the outbreak strains of bacteria. In this outbreak, 48 percent of victims are 10 years old or younger.
The live chicks and ducklings thought to be the source of this outbreak were sold by Mt. Healthy Hatchery in Ohio.
“This hatchery uses multiple source flocks to obtain eggs and chicks, so it is unclear at this time where the contamination originated,” said CDC in its outbreak report.
Mt. Healthy Hatchery is the same operation whose baby poultry were the source of a 2012 outbreak of Salmonella Infantis, Salmonella Newport and Salmonella Lille that sickened 195 people in 27 states and led to 2 deaths.
At least 196 patrons and four employees of Las Vegas tapas restaurant Firefly have fallen ill in the Salmonella outbreak health officials have called Nevada’s worst outbreak of the past decade, according to a report released Friday morning by the Southern Nevada Health District.
The outbreak sickened diners from 20 U.S. states, along with Canada and the United Kingdom.
Both Firefly on Paradise Ave. and neighboring restaurant Dragonfly, which shares kitchen facilities, have been closed since April 26 after the health district received reports of eight separate groups of patrons experienced illness. A health inspection at the establishment cited 44 demerits for Firefly and 47 for Dragonfly, including improper cooling practices, holding temperatures and storing of potentially hazardous foods that included “raw animal products” being stored above ready-to-eat foods.
Health investigators confirmed 16 of the cases through laboratory analysis to have been infected with Salmonella serotype I:4,5,12:i:-. Three of the confirmed cases were employees, each of whom consumed food at the restaurant and experienced illness onset timing showing they were not the source of the outbreak.
No new illnesses have been reported since May 1.
In a written statement to the community, Firefly owner John Simmons said there were no plans to reopen Firefly at the closed location, but would instead move the restaurant to a new building on the same street.
“Firefly has been a proud member of Southern Nevada for 10 years and we are optimistic that the combination of moving to this new location, that has a kitchen as large as the entire original Firefly restaurant, and the recommended retraining on operations and procedures, will help us regain the confidence of the community,” Simmons said.
Health investigators could not pinpoint a specific food item as the source, though ill patrons were much more likely to eat certain menu items when compared to patrons who didn’t fall ill in a case-control study.
The investigation initially looked at Firefly’s unpasteurized egg-based aioli sauce because of the number of ill patrons who reported eating it, but further analysis showed it was not the cause. Specific ingredients such as parsley and grated hard cheese underwent additional scrutiny but were not shown to be a likely source.
Inspectors visited two other Firefly establishments in Clark County and did not find evidence of Salmonella contamination. One location, on Eastern Ave. in Henderson, received an ‘A’ rating following its inspection. The other, on Sahara Ave. in Las Vegas, was cited for 30 demerits, which were found to be corrected in a follow-up inspection.
Health officials are still performing laboratory analysis on a number of individual food items in an effort to identify an outbreak source. Three Salmonella samples have also been sent to a federal lab to test for antimicrobial resistance.
Those sickened in the outbreak included travelers from the following 20 states:
AZ, CA, CO, HI, IL, MA, MN, MS, NC, NE, NV, NY, OH, OK, OR, PA, SC, TX, UT, and WA.
Salmonella serotype I:4,5,12:i:- is a variant of Salmonella Typhimurium most notably associated with a 2007 outbreak associated with Banquet pot pies that sickened at least 401 people.
A French-owned bakery in Seattle, a juice processor in Melville, NY, and a seafood processing facility in San Juan Bautista, CA are subjects of recent warning letters from the U.S Food and Drug Administration (FDA).
On April 18, FDA warned Biofournil of America, Inc. about its Seattle bakery after an inspection documented numerous violations of Current Good Manufacturing Practice regulations for the manufacturing, packing, or holding of human food.
Among specific violations observed were pest on the premises, including dead insects in the baking and proofing area and live insects under the wall of a baking oven. Mouse excreta and urine stains were also found in abundance.
Transparent plastic bags were being used repeatedly for dough production, and contained bits of dried dough. Soiled triangular cardboard cutouts were being used as patterns for croissants.
Further, toxic compounds were not properly stored, employee hand washing facilities were inadequate, and the plant and facility had problems when it came to keeping the bakery clean and in good repair.
On April 26, FDA sent a 7-page warning letter to Melville, NY-based Sirob Imports Inc. about its Lindenhurst, NY manufacturing facility for acidified foods and juice products. FDA said its inspection found serious violations, including insanitary conditions of filth that cause adulteration of the products being produced there.
The company did respond to the agency’s Form 483 Inspectional Observations report, but the warning letter says FDA was not provided with any supporting documentation and the manufacturer has a history of promising corrective actions, but not taking them.
The warning letter then goes on to outline the company’s extensive regulatory shortcomings in the areas of acidified foods, juice Hazard Analysis and Critical Control Point plans, and Current Good Manufacturing Practices.
On May 1, FDA sent a warning letter to Pacific Harvest Seafood based in San Juan Bautista, CA over serious violations of seafood HACCP regulations. “Accordingly, your seafood products, including fresh, refrigerated scombroid finfish Mahi Mahi and ready-to-eat refrigerated, cooked Dungeness Crabmeat in hermetiucally sealed containers, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the warning letters says.
In addition to saying Pacific Harvest must have a HACCP for each species of fish it processes, FDA called out the company’s “transit control strategies.” The agency is concerned about transit times for fish taking too long and that fish delivered in open-bed trucks being completely covered in ice.
FDA gave each company receiving a warning letter 15 business days to respond.
Amidst growing regulations and interest in ISO (International Organization for Standardization) certification, Exact Scientific Services has become one of the few testing laboratories in Washington State that is ISO 17025 certified.
“The BRC, and now the recent SQF Code for Product Sampling, Inspection and Analysis, were no small part of our decision to pursue this strenuous process,” says Kent Oostra, CEO and Laboratory Director for Exact Scientific Services, a chemistry and microbiological testing and compliance lab working with food, nutraceutical, environmental and agriculture clients.
For instance, SQF Code, Edition 7, 2.5.6 mandates that, “Where external laboratories are utilized to conduct input or product analysis, the laboratories shall be accredited to ISO 17025 or an equivalent national standard.”
In addition, the U.S. Food and Drug Administration will be requiring labs to be accredited to ISO or an equivalent standard if they do detained samples, pending approval.
Nutraceutical companies also enter into the ISO discussion in that ISO 17025 certification meets such requirements as CFR 111 FDA for food and dietary supplement manufacturers.
Unexpected benefits: internal auditor and customer assurance — at a global level
Himself a farmer, Oostra knows the practical implications of these regulations – and how they can impact the bottom line of his clients. So he wanted to do it right on behalf of making life a little easier for his clients, and in being able to share his experience with others along the way.
Fortunately, Oostra discovered a silver lining along the way. “We uncovered a number of surprising benefits for our clients through ISO certification,” he says. “Our clients are telling us that ISO provides peace of mind during internal audits, as well as assurances for their customers.”
According to Barleans Organic Oils’ Director of Quality Assurance, Mike Kaminski, an Exact client, ISO accreditation “helps us when we have internal audits and they ask us if our lab has certifications. The ISO speaks volumes and helps us a lot.”
Client Enfield Farms agrees. According to Quality Assurance Manager Laura Macaulay, “ISO is gaining in importance in our audits. A third-party lab negates the potential for conflict of interest, and an ISO certified lab negates any concerns for testing procedures.”
Enfield’s Macaulay points out another benefit, “Our customer base is a huge reason to have third-party ISO certification. Customers are everything in the food industry.”
And since ISO is an internationally recognized accreditation by ILAC, ISO accredited laboratory results receive a form of international recognition which allows their data to be more readily accepted.
A client working in offices across the globe points out key benefits from internationally recognized accreditation: “We don’t need to get products double tested in different markets to accommodate regional requirements. ISO accreditation also means that we can be assured Exact Scientific’s processes are audited and certified under strict guidelines, which supports our SQF auditing requirements.”
This stringent mandate for precise and accurate testing ends up minimizing risk, helps reduce or eliminate the need for retesting, and builds confidence for customers through thorough evaluation of products by an independent and competent testing laboratory. “All of this reduces costs, improves acceptance, and positively impacts the bottom line,” says Oostra.
Indeed, ISO 17025 looks at a laboratory’s ability to produce precise and accurate tests. ISO evaluates the technical competence of the staff, validity of test methods, traceability of the testing, quality assurance of data and the testing environment, and suitability, calibration and maintenance of test equipment. And to ensure continued compliance, accredited laboratories are audited on a yearly basis to check that they are maintaining their technical expertise.
It was worth it
The work has also paid off by providing benefits to Exact itself. “Besides now being one of the few testing laboratories in Washington State, and a relative few nation-wide that is ISO 17025 certified,” Oostra says, “Exact has also became one of few, if not the only, ISO lab in Washington State that is accredited to gluten, proximates, rancidity, and fatty acid profile testing, and that meets USP methods needed by supplement companies.”
Looking back on the process, Oostra says it wasn’t easy, but it was worth it in several practical ways: “It has helped streamline our work, organize our flow and serve our clients better, wherever they are located in the world” In the big picture,” Oostra says, “ISO Certification has given one more opportunity of providing our clients and employees with a higher standard of service. In fact, it has been such a benefit, we apply it to all aspects of our own business each and every day.”
The Jackson County Health Department is now asking anyone who ate at the restaurant between April 26 and 29, or May 1, 2013, to contact the health department to receive information on Hepatitis A in the event of exposure. Those at risk may not fall ill if given a vaccine within 14 days of exposure.
Anyone who ate at the restaurant on those days and experienced fever, headache, vomiting, or diarrhea are encouraged to contact a healthcare provider.
Health investigators in Jackson County are trying to determine if any other people have been infected with the virus.
Tibor’s Gourmet, of Palmdale, Calif., is recalling approximately 200 pounds of ready-to-eat smoked pork sausage distributed in Los Angeles and Orange County because they were produced without inspection from the U.S. Department of Agriculture.
The following two products are subject to recall:
- “Ready To Eat” Gourmet Hungarian Brand Mild Smoked Sausage
- “Ready To Eat” Gourmet Hungarian Brand Spicy Smoked Sausage
Each product bears the establishment number ‘EST. 44866′ and was produced between February 25 and May 2, 2013.
The company was in the process of receiving a Grant of Inspection from the USDA, but had not yet received it. USDA investigators became aware of the issue after finding the company’s product for sale in a retail location.
No illnesses have been associated with the product.
This article was co-authored by Dr. Kathleen Vidoloff, Emergency Risk Communication Officer for Oregon Public Health Division, and Dr. Jean O’Connor, former Oregon Deputy Public Health Director.
One of the many roles of public health is to protect consumers from threats like foodborne outbreaks. Much of this hinges on quickly getting out clear messages to the public that provide simple steps to help stem the spread of disease. This is something public health professionals have been doing for over a hundred years, but a recent outbreak of Salmonella Heidelberg got us wondering, “Are we doing enough to keep the public safe? Are we too slow? And, how can we improve?”
That’s not to say there weren’t triumphs in this outbreak, but like most responses we had a moment of self-reflection when the crisis was over and we were able to take a step back and consider our methods. What we found was a need for stronger policies and faster messaging to the public.
Between June 2012 and January 2013 epidemiologists with Oregon Public Health, along with the Washington State Department of Health, CDC, and the US Department of Agriculture independent of each other, began noting increases in the number of Salmonella infections. Thanks to surveillance systems like CDC’s Pulsenet and National Retail Monitoring System (NARMS), epidemiologists were able to narrow down the specific genetic make-up of the Salmonella in question (Salmonella Heidelberg) and link it to raw or undercooked Foster Farms brand chicken.
The Pros and Cons
For decision-making and public information, we did several things right. Including:
- Communicating with the company responsible for the tainted chicken, which helped provide critical information needed to confirm the source.
- Developing simple messages that explained the outbreak and how individuals could prevent Salmonella were developed. These messages followed the Crisis & Emergency Risk Communication framework, which encourages the use of transparent messaging that provides the public with meaningful actions to protect themselves from harm.
- Growing a strong partnership between our epidemiologists, leadership, and risk communication officer over the course of the investigation provided a basis for mutual trust and respect. This rapport led to faster message development.
- Finally, by following Incident Command System principles, we were able to better coordinate communication activities across the several agencies involved.
Although we were successful in getting the message out, there were several factors that we felt slowed this outbreak response down:
- Despite having several state and federal agencies collecting clues, we weren’t doing it together, which meant more time was spent on the backend to get everyone on the same page.
- Not all staff had been trained on the laws and policies related to release of information, which was needed for rapid decision-making during the outbreak.
- Oregon Public Health (as we suspect is the case with many state health departments) has no risk communication policy, which meant not everyone was on the same page about how and when we would share information and release information to our partners and the public.
- Political happenings unrelated to the outbreak ended up blocking the release of important health messages by two days — another all-too-common experience for many risk communicators.
How Can We Improve?
Given these pros and cons, we still think much can be done to improve decision-making and risk communication during an outbreak. The federal Food Safety and Modernization Act of 2011 was an important step toward improving the safety of our nation’s food supply. However, our experience responding to Salmonella Heidelberg outbreak in Oregon also suggests that additional state and federal policies are needed not only to prevent outbreaks, but also to help public health authorities implement best practices in risk communications and public health responses when outbreaks do occur.
No state health department funded with federal dollars — CDC or otherwise — should be without a well-developed risk communications plan that can be operationalized at a moment’s notice. Similarly, states should be held accountable to ensure information about emerging outbreaks is shared between epidemiologists, other partners, and response staff, and to identify the triggers for public warning and messaging about health risks. Depending on the risk, even a one day delay in response could mean more sick people, and in turn more health care and social costs.
We do know from our own experience that state and local public health agencies sometimes face unique challenges in balancing the need to be right and credible with the public’s need to know about potential health threats. In many states, there are laws that—very appropriately–prevent public health agencies from releasing certain types of identifiable or highly sensitive information. However, there are almost no laws that ensure public health officials with information about a health risk be allowed or even required to warn the public, free from interference by political forces or threats of litigation by the food industry.
Policies that encourage health departments to share what they know, possibly by providing immunity from lawsuits when warning the public about risky food products, are needed. Policies that ensure that all parties work together as early as possible in a suspected outbreak are needed, along with policies that ensure that health care technologies can capture and send essential data from the health care setting to public health officials.
The public health system is under more pressure than ever to be relevant, timely, and right. While important progress has been made over the past decade, identifying outbreaks, analyzing them, and disseminating information to the public requires the expertise of highly trained professionals with the tools and policies that enable them to do their jobs.
Health officials too must sometimes strike the difficult balance between the political realities of our work and the public’s health and safety. As Dr. Martin Luther King, Jr. said “[T]here comes a time when one must take a position that is neither safe, nor politic, nor popular, but he must do it because Conscience tells him it is right.” As public health professionals, we have a responsibility to our colleagues, constituents, friends, families and ourselves to improve the quality and performance of our public health systems and services.
For more on this topic check out the Pew Charitable Trust report, “Too Slow” analyzing the detection and response to a 2011 outbreak linked to ground turkey.
Disclaimer: This blog post does not represent the official views of the Oregon Public Health Division or the Oregon Health Authority
About the authors:
Dr. Kathleen Vidoloff is the Emergency Risk Communication Officer for Oregon Public Health Division where she oversees the development, implementation and evaluation of risk communication activities. She is also an Adjunct Professor of risk communication at the University of Oregon. Dr. Vidoloff previously worked as a contractor at the U.S. Centers for Disease Control and Prevention evaluating emergency risk communication strategy for international and domestic emergency responses.
Dr. Jean O’Connor was Oregon’s Deputy Public Health Director and the Principal Investigator for Oregon’s public health preparedness and infrastructure improvement funding awards from 2011 to 2013. She has more than 15 years of experience with CDC, state public health agencies, and non-profit organizations, including work on numerous responses to domestic and international public health events. She is also an Adjunct Associate Professor at Emory University’s Rollins School of Public Health where she teaches law and policy.
Disclaimer: This blog post does not represent the official views of the Oregon Public Health Division or the Oregon Health Authority
Editor’s Note: This article originally appeared on CDC’s Public Health Matters Blog May 1, 2013.
Europe and America appear to be taking decidedly different approaches to honeybee colony collapse.
The European Union just adopted continent-wide restrictions against the neonicotinoid class of insecticides called out by the European Food Safety Authority as especially damaging to bees. In the U.S., however, a newly released comprehensive scientific report on honey bee health says multiple factors are contributing to colony decline, including parasites and disease, genetics, poor nutrition and pesticide exposure.
“There is an important link between the health of American agriculture and our honeybees for our country’s long term agriculture productivity,” said USDA’s Kathleen Merrigan. “The forces impacting honeybee health are complex and USDA, our research partners, and key stakeholders will be engaged in addressing this challenge.”
Merrigan’s comments came on her last day as USDA Deputy Secretary.
Acting EPA Administrator Bob Perciasepe said the joint report shows significant progress is being made to return honeybee colonies to health, but more work needs to be done. He said the problem is complex involving “a combination of stressors.”
And this week, USDA released its findings of the damage done to honeybee colonies during the winter of 2012-13, finding a decline of 31 percent or about 800,000 colonies.
It marks another year that U.S. bee populations have experienced a mass kill off. USDA estimates are that there are $20 billion in annual harvests relying upon bee pollination. Decline during the previous winter of 2011-12 was 22 percent.
Scientists on both sides of the Atlantic have been investigating the mysterious collapse of honeybee colonies for most of the last decade. It’s been a difficult phenomenon to track because whatever the name might imply, bees are not dying in the hives, but simply flying away and not returning.
Since the EFDA report was issued early in 2013, support for a ban on the bee-harming pesticides have grown and 15 of the EU’s 27 member nations voted to remove the so-called “neonics” from the market.
Because the EU vote fell short of a “qualified majority,” the decision on whether to go through with the ban was left up to the European Commission. Tony Borg, the Health and Consumer commissioner, pledged his “utmost” to protect the bees.
The campaign to ban “neonics” pesticide is not limited to Europe. Beyond Pesticides, the Pesticide Action Network North America, and the Center for Food Safety have petitioned EPA to request the bee-harming pesticides be removed from the market.
With the new EPA-USDA report, a ban on those pesticides in the U.S. seems less likely.
A turning point for a U.S. approach to the honeybee problem may have come last year with the National Stakeholders Conference on Honey Bee Health at Pennsylvania State University gained consensus among researchers and managers involved not to accept a single-cause theory to the problem.
Instead it called for more research and supported the Colony Collapse Disorder Steering Committee to develop an action plan with five and ten year priorities. It foresees collaborative efforts involving farmers, beekeepers, researchers, federal researchers, and the public.
The EU ban on the pesticides known as neonicotinoids will last for two years.
Sens. Kirsten Gillibrand (D-NY), Dianne Feinstein (D-CA), and Susan Collins (R-ME) on Wednesday introduced a bill that would require the U.S. Food and Drug Administration to collect more data on exactly how antimicrobial drugs are used in food animal production.
The Antimicrobial Data Collection Act calls for increased data collection by the Food and Drug Administration (FDA), enhanced transparency and public awareness of antimicrobial drug use in agriculture and strengthened FDA accountability regarding unsafe antimicrobial drug use. The Centers for Disease Control estimates that, each year, antimicrobial resistance costs taxpayers $20 billion in excessive healthcare and results in more severe illness and a greater risk of death for infected patients. Currently, there are at least six multidrug resistant major human pathogens.
“Antimicrobial resistance is a public health concern that needs to be adequately addressed,” said Senator Gillibrand. “Increased data collection, transparency, and accountability are part of a comprehensive solution that will help protect American citizens from drug resistant microbes, saving lives and tax dollars.”
“Our bill would not create any new reporting requirements for drug companies, feed mills, or farmers. It would only require the FDA to provide more transparency in reporting the antimicrobial data which is already being reported to it,” said Senator Collins.
Specifically, the legislation requires a pilot program to look into new data sources on antibiotics used on food producing animals. The FDA will create a comprehensive data collection strategy, based on the new data sources, in order to increase data availability to the public, increasing the FDA’s transparency. The FDA’s increased transparency would shed light on information about antimicrobial drugs used in agriculture that are not currently made public, such as dosage form, strength and targeted animals. The Government Accountability office will then audit the FDA to determine if the data collection for antimicrobial resistance programs is effective in protecting public health.
An outbreak of Salmonella Saintpaul linked to imported cucumbers has sickened at least 81 people in 18 states, according to the U.S. Centers for Disease Control and Prevention.
That’s up from the 78 illnesses CDC reported April 25. The number of patients hospitalized as a result of their infections has risen from 14 to 16 since that time.
The updated number of victims, by state, is as follows: Arizona (11), California (28), Colorado (1), Idaho (2), Illinois (3), Louisiana (1), Massachusetts (1), Maryland (1), Minnesota (9), Nevada (1), New Mexico (2), North Carolina (3), Ohio (3), Oregon (2), South Dakota (2), Texas (6), Virginia (3) and Wisconsin (2).
The first outbreak victim fell ill on January 12 of this year, and the latest known illness onset was April 19. However, health officials note that illnesses with an onset date of April 7 or later may not have been reported yet.
The strain of Salmonella Saintpaul causing these illnesses has been traced back to cucumbers from Daniel Cardenas Izabal and Miracle Greenhouse in Culiacán, Mexico, according to CDC.
FDA has issued an import alert regarding produce from these two companies. Fresh fruits and vegetables may not be imported from these firms until testing shows that they are clear of Salmonella.
The Brazos County Health Department has confirmed five of the illnesses, and investigators believe another three patients are infected with the same strain of bacteria.
Two related children under the age of five have been hospitalized at Texas Children’s Hospital in Houston for the past week, The Eagle reports. The other six cases are adults and were not hospitalized.
Investigators are still searching for a possible outbreak source, saying that the patients did not eat at the same restaurant.