2016 surf and sandThe editors of Food Safety News have complied this list of major news from 2016. While the year will no doubt be best remember for its presidential election, there were other milestones worth remembering as we prepare to turn the page and begin the New Year.

No. 10 — Mike Taylor leaves FDA, heads to the major leagues
The food safety leadership changes now occurring across the board in the federal government began last spring when Dr. Stephen Ostroff took over for attorney Mike Taylor as the U.S. Food and Drug Administration’s deputy commissioner for foods and veterinary medicine.

Mike Taylor
Mike Taylor

Taylor, with a JD from the University of Virginia College of Law,  returned to government at the birth of the Food Safety Modernization Act (FSMA), which was the federal government’s response to a string of troubling and often deadly outbreaks of foodborne illness.   FSMA was passed in the final days of 2010 with large bipartisan margin.

Taylor’s appointment to implement it was not without controversy. After all, he led an internal policy group for fanatic-hated Monsanto Company for 16 months after he left government the first time.  His many critics never knew or cared that his USDA leadership during the Clinton administration banned a dangerous pathogen in meat (E. coli O157:H7) and for the first time adopted modern, science-based methods for preventing or minimizing such pathogen contamination in raw products.

The Obama administration brought him back for a second act to implement FSMA, and run the food divisions of FDA. FSMA called for prevention, not just reaction to  food illnesses and deaths.  Taylor headed up teams of FDA personnel who were charged with writing and adopting rules to make the new law work.

Taylor’s exit, to the well-connected Freedman Consulting, last June marked the start of the current period of transition being experienced at FDA and across the other federal good safety agencies. The changes in personnel probably won’t be complete until well into 2017.

As the man at the center of both  the E. coli E. coli O157H:7  crisis 22 years ago and implementing FSMA since 2010,  Taylor’s departure from government was a major food safety story of 2016.

No. 9 — Catfish inspection program survives the move to USDA

Workers kill pangasius catfish before transfering them to the next processing line in a seafood factory in the Mekong Delta of Vietnam. (© Jamesbox | Dreamstime.com)
Workers kill pangasius catfish before transfering them to the next processing line in a seafood factory in the Mekong Delta of Vietnam. (© Jamesbox | Dreamstime.com)

Just before the year began, catfish inspection was moved to the Food Safety and Inspection Service (FSIS) under a Memorandum of Understanding signed by both USDA and the FDA. Under that agreement, called for in both the 2008 and 2014 Farm Bills, the new catfish inspection program took effect on March 1, 2016, with an 18 month transition period. Next Sept. 1, full enforcement begins.

Yet, it’s somewhat surprising the new catfish inspection program remained intact and on-track as the year ended. The Senate voted to shift it back to FDA under a resolution that will expire at year’s end without a House vote. The steam for such a vote might have been lost after a Dec. 7 hearing at which the Government Accountability Office acknowledged the MOU ended duplication between FDA and USDA.

No. 8 — Blue Bell just can’t shake the Listeria blues
Blue Bell Ice Cream

After a tough year in 2015 that saw modern science identify and link a deadly, five-year, multi-state Listeria outbreak to its iconic ice cream, Blue Bell Creameries was supposed to be on a recovery track in 2016.

Ice cream lovers waited with spoons in hand for announcements about when Blue Bell would be back in their local stores. Company officials dribbled out information as the U.S. Department of Justice investigated what Blue Bell knew and when in relation to the Listeria that sickened 10 and killed three.

Justice won’t comment on the investigation, so the Brenham, TX, ice cream giant is headed into another New Year with the possibility of criminal charges it its future. Blue Bell officials came out early in 2016 with a report stating Listeria will always be a threat. They said their new cleaning, sanitizing and testing programs are keeping their customers safe as possible, though.

Texas officials imposed a fine and put Blue Bell on a short leash in July 2016. An agreement between Blue Bell and the Texas State Department of Health Services requires the company to pay $175,000 within 30 days of the signing of the agreement. Another $675,000 — for a total fine of $850,000 — must be “held in abeyance” and would go to the state if Blue Bell fails to meet food safety requirements in the coming 18 months.

Two months after signing the agreement with Texas, Blue Bell was again recalling ice cream because of potential Listeria contamination, but this time blaming cookie dough from a supplier as the source. That claim turned out to be true and cookie dough producer Aspen Hills Inc. of Garner, IA, recalled its dough, triggering a series of secondary recalls of other products.

No. 7 — DeCoster becomes a case name as the egg men appeal to Supreme Court
jackandpeterDeCoster_406x250-e1401772183375It was a surprising twist of events that bought us to this point, but it’s possible that by this time next year the DeCoster name will be case name found in law books.

That’s what will happen if the U.S. Supreme Court decides to take up the appeals of Austin “Jack” and Peter DeCoster v. U.S. The court has invited  the DeCoster attorney, former acting Attorney General of the Untied States, Peter D. Keisler,  to file a writ of certiorari by Jan. 10, 2017.

Acceptance of the writ, which is rare, would mean the two DeCoster v. U.S. cases would be heard on a consolidated basis by the highest court in the land. It would also likely mean the DeCoster name would become a case name. At one time, many though 82-year old “Jack” DeCoster was the largest egg producer in the U.S.

But the DeCoster name was also known for the family businesses that had environmental, labor, and food safety violations from Iowa to Maine.     Their history is why a federal judge in Sioux City, IA, decided to sentence both “Jack” DeCoster and his 52-year old son Peter, each to three months in federal prison.

Each DeCoster plead guilty to adulterated food from their egg production facilities in Iowa getting into interstate commence, and each agreed to pay $100,000 fines.   A near-record $6.8 million fine was also paid by their Quality Egg Corp., which plead guilty to two felonies and the same misdemeanor each  DeCoster was charged with.

DeCoster attorneys argued the DeCoster’s as “responsible corporate officials” without personal knowledge of a violation, cannot be jailed for it.   They appealed and lost, but that set the case up for the Supreme Court because 8th Circuit decision is not consistent with precedents in other circuits.

And while, few get to the Supreme Court, only the high court can bring about consistency among the circuit courts. That’s how DeCoster might become a case name.

No. 6 — FSMA goes live

The birth date for the Food Safety Modernization Act (FSMA) was Jan. 4, 2011, when it was signed into law by President Obama. The start date, however, came during May 2016 when all seven of foundational rules to implement the new law were finished.

The starting point remains where its been for awhile — about 48 million illnesses or 1 in 6 Americans get sick from foodborne diseases each year. The federal Centers for Disease Control and Prevention says 128,000 people require hospitalization and 3,000 die.

The foundational rules include: Preventive controls for human foods; Preventive controls for animal food; produce safety; foreign supplier verification; third-party certification; sanitary transportation; and intentional adulteration. All are now effective, although there are staggered compliance dates and enforcement dates, depending on business size and other factors.

No. 5 — Listeria in CRF Frozen Foods products and plant

Another multi-year, multi-state Listeria outbreak — this one running from September 2013 through May 2016 — was discovered in 2016 and traced to CRF Frozen Foods of pasco, WA, thanks to public health scientists sharing data.

The Centers for Disease Control and Prevention ultimately reported that nine people were sickened across four states. All required hospitalization. Three died, but only one of the deaths was specifically attributed to Listeria infection. CRF closed its plant and ultimately recalled all of the frozen vegetables and fruits it had produced from May 1, 2014, trough June 2016.

The FDA facilitated the recall of at least 456 products related to this outbreak. CRF Frozen Foods recalled 358 products and at least 98 other products were recalled by firms that received CRF’s recalled products. Ajinomoto Windsor Inc. recalled almost 50 million pounds of its meat products made with CRF’s vegetable and fruit products.

Although CDC closed its outbreak investigation there is an ongoing threat because of the long shelf life the frozen products, some of which have best-by dates through April 2018. Consumers could still become ill from the products because Listeria monocytogenes can survive freezing temperatures.

No. 4 — E. coli outbreak linked to flour rocks General Mills, food industry

The General Mills plant in Kansas City, MO, is just northeast of the heart of the city's downtown area. (Photo by Coral Beach)
The General Mills plant in Kansas City, MO, is just northeast of the heart of the city’s downtown area. (Photo by Coral Beach)

As with the ongoing Listeria threat from CRF’s frozen vegetables and fruits, additional E. coli infections are possible in a 24-state outbreak traced to flour made at General Mills’ plant in Kansas City, MO.

And as with CRF and Blue Bell, high-tech sleuthing by epidemiologists at the CDC and state health labs across the country are credited with cracking the case. Initially investigators, who had been watching the situation since December 2015, found a common denominator of raw dough among some of the 63 victims.

The dough led to flour and General Mills ended up recalling a total of 45 tons of the baking mainstay sold in consumer packages and large bulk lots to other food companies. Federal investigators matched E. coli from flour from bags in consumers’ homes in multiple states to pathogen isolates infecting the outbreak victims, ultimately identifying two strains O121 and O26.

General Mills issued its first flour recall related to the outbreak on May 31. After the outbreak strain of E, coli was found in victims’ homes the company expanded the recall twice.

In addition to the recalled General Mills flour — Gold Medal, Signature Kitchens and Wondra brands — a variety of packaged and fresh-baked foods, as well as shelf-stable baking mixes, were pulled back by manufacturers because they were made with the implicated flour. Some meat and poultry products that had the flour as a breading ingredient were also recalled.

National brands including Marie Callender’s and Betty Crocker were among those implicated in the main and secondary recalls. A list of the recalled products is available on the CDC website.

The outbreak also caused FDA and CDC to repeat warnings not to eat raw dough or batter.

3. — Dole knew of Listeria but kept salad plant running; 4 of 33 victims died

The salad production facility in Springfield, OH, was highlighted in Dole’s 2010 corporate report.
The salad production facility in Springfield, OH, was highlighted in Dole’s 2010 corporate report.

A number of factors combined to propel this ongoing story to the No. 3 spot  for 2016 — it spanned an international boundary; was directly responsible for one death and implicated in three others; spurred the CDC to alter its outbreak victim questionnaire; and launched a criminal investigation by the U.S. Justice Department.

The criminal investigation is still pending.

Inspection reports obtained by Food Safety News revealed that company officials at Dole Fresh Vegetables Inc. knew their salad production plant was contaminated with Listeria since at least mid-2014. Dole did not suspend production at the Springfield, OH, plant until on Jan. 21, 2016, after a random test by state officials found the pathogen in a bagged salad from a grocery store.

From mid-2014 through the end of 2015 internal testing revealed Listeria in the plant at least nine times. Dole’s vice president for quality assurance and food safety, as well as the company’s quality assurance manager, were also aware of internal tests on Jan. 5 and 7, 2016, that showed Listeria on equipment and other surfaces in the plant.

Dole continued to produce and ship salads until after the CDC posted an outbreak notice.

The CDC had become aware of the ongoing Listeria outbreak in fall of 2015. Investigators caught a break and linked the outbreak to Dole salads in 2016 after the Listeria found by the routine product sampling by the Ohio Department of Agriculture matched the outbreak victims.

The coincidental nature of the detection of the source was another example of how the investment of government resources into the CDC’s PulseNet database and whole genome sequencing of pathogens is paying off.

This outbreak also revealed a hole in the CDC’s outbreak victim questionnaire. It did not ask victims if they had eaten leafy greens before becoming ill, partly because Listeria had never before been linked to them.

“During December 2015 and January 2016, eight new or previously interviewed patients or their surrogates participated in open-ended interviews or provided shopper card records, and all reported consuming leafy greens in the month before illness onset,” CDC reported when it announced it was adding the leafy greens question to its standard questionnaire.

The Dole salad outbreak generated high consumer interest, according to the CDC, which reported the agency’s Web page on the outbreak received more than 787,000 page views, more than any other outbreak to date.

No. 2 — Federal GMO label law crushes states’ efforts to force disclosure

The Vermont law required food labels to declare genetically engineered ingredients.
The Vermont law required food labels to declare genetically engineered ingredients.

A Senate compromise bill for labeling food with genetically modified ingredients earned bipartisan support in both chambers of Congress and was signed by President Barak Obama in 2016.

The new law ends years of debate and supersedes attempts by states to impose disclosure requirements for labeling on foods that are made with genetically engineered or genetically modified organisms (GMOs).

The only state law in effect at the time the new federal law was signed was Vermont’s, which took effect July 1, 2016.

The Secretary of Agriculture must now come up with a symbol or notice about GMOs that food manufacturers can use on their packages. QR codes that can be scanned with smartphones, website addresses and toll-free telephone numbers are among the options.

More than 1,000 food and agricultural organizations supported the compromise. It allows food producers to choose how they want to disclose the presence of genetically modified ingredients in their products.

In a letter circulated by the Center for Food Safety, civil rights leader Jesse Jackson asked Obama to veto the compromise bill because of its reliance on smart phones.

Pamela G. Bailey, president and CEO of the Grocery Manufacturers Association (GMA), urged Obama to “sign this bill quickly.” GMA did much of the heavy lifting on behalf of the national labeling law.

“Vermont’s mandatory on-package GMO labeling law took effect on July 1 and threatens the nation’s food supply chain with costly and lasting disruptions,” Bailey said in July 2016. “Already, consumers in Vermont are finding fewer products on the shelves and small businesses are facing higher costs of compliance.”

No. 1 — Chipotle Mexican Grill finds out how much food safety failures cost

Chipotle founder and co-CEO Steve Ells
Chipotle founder Steve Ells posted this photo of himself handling food bare-handed when he announced new food safety measures for the burrito chain. In recent weeks he again demonstrated inappropriate food handling during a “Today Show” segment in a Chipotle kitchen when he poked meat on the grill with his bare fingers.

There is a lot that’s still unknown about the string of foodborne illness outbreaks among patrons of Chipotle Mexican Grill restaurants in 2015, but one thing became crystal clear in 2016. Bouncing back from burrito blunders isn’t as easy as founder Steve Ells said it would be.

The last in the series of six 2016 Chipotle outbreaks wasn’t declared over until February 2016. By then the Denver-based fast-food chain’s stock had dropped from its all-time closing high of $757.77 on Aug. 5, 2015, to below $400. By June 14, 2016, analysts said they thought the stock would bottom out at $384.77 per share, but it dipped even lower in recent weeks.

Through 2016 the chain’s founder predicted customers would return. He and the company gave away free food, retrained employees in food handling and hand hygiene, imposed an automatic closure protocol in the event of anyone vomiting at a restaurant, floated new product ideas, gave away more free food and made the talk show rounds.

The third-quarter numbers did not bear out Ells predictions. Net income for Q3 was only $7.8 million, compared with the previous year when Chipotle took in $144.9 million net.

Another crucial number for the third quarter was much lower than Ells had hoped. Same store sales were down more than 21 percent. The third quarter was also the fourth consecutive quarterly report showing year-over-year revenue declines

Whether changes at the top, made in late 2016, will boost the chain to its earlier glory will be revealed Feb. 2, 2017, when the fourth-quarter results are reported.

Those changes include billionaire investor Bill Ackman of Pershing Square Capital Management picking up a 9.9 percent stake in Chipotle; the resignation Monty Moran who had been co-CEO since 2009; and the installation of four new board members.

The bottomline impact of civil lawsuits brought by more than 100 of the more than 500 people sickened in the Chipotle outbreaks will remain unknown as confidentiality clauses in settlement agreements gag all parties.

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