Source: The Houston Chronicle, May 8, 2015
Posted on: http://fpn.advisen.com
Blue Bell’s listeria crisis worsened Thursday as federal regulators released documents showing Texas’ iconic ice cream maker knew about bacteria problems in its plants as early as 2013 but failed to correct them.
The reports were released by the U.S. Food and Drug Administration after a Freedom of Information Act request by the Houston Chronicle and other news outlets. Blue Bell is already reeling from a recall that leaves it without sales revenue.
The FDA findings raise troubling new questions, including why — given that Blue Bell knew listeria was in its Oklahoma plant for years — the company didn’t shut down operations as soon as listeria turned up in ice cream this year. Blue Bell’s incremental recalls and public statements initially suggested listeria was limited to a single production line.
Reports from the FDA and South Carolina officials also show Blue Bell was notified Feb. 13 about listeria in its single-serving Chocolate Chip Country Cookie Sandwich and Great Divide Bar, manufactured in Brenham, but didn’t issue its first recall until March.
“Who is in charge of making the decisions?” wondered Seattle attorney and food safety expert Bill Marler. “Somebody has got to be sophisticated enough … that they should just shut things down.”
Blue Bell officials acknowledged shortcomings Thursday.
“Several swab tests did show the presence of listeria on nonfood surfaces in Blue Bell’s Broken Arrow (Oklahoma) plant in 2013,” company spokesman Joe Robertson said in an email. “As is standard procedure for any such positive results, the company would immediately clean the surfaces and swab until the tests were negative. We thought our cleaning process took care of any problems, but in hindsight, it was not adequate, which is why we are currently conducting such a comprehensive re-evaluation of all our operations.”
In a separate statement Thursday, company officials said they are preparing detailed responses to the FDA findings and reiterated their commitment to conduct extensive plant upgrades, new product testing and employee training. But that will take time.
They said Blue Bell won’t return to stores for at least “several months” — another blow to the privately owned company.
No smoking gun
The new reports, while highlighting problems in Blue Bell cleaning programs, stop short of providing a smoking gun for how listeria entered the ice cream, food safety consultant Larry Keener said.
The FDA documents show Blue Bell’s own testing programs in 2013 indicated listeria on surfaces like floors, pallets used to store and carry ingredients, and other non-food-contact surfaces at Broken Arrow.
And even though repeated tests — five samples in 2013, 10 samples in 2014 and two samples in 2015 — showed listeria, there apparently were no significant changes to Blue Bell’s sanitation procedures or efforts to find the root cause of contamination, the reports say. What’s more, the company didn’t check surfaces that do come into contact with food.
In 2014 and 2015, Blue Bell found high levels of another type of bacteria, coliform, along the entire production process: raw materials, in-process ice cream and finished products. The levels violated limits under Oklahoma regulations.
List of infractions
FDA inspectors looked at the plants in March following the outbreak. They describe dirty conditions previously unreported. Among the findings from Oklahoma:
Condensation inside the plant dripped into frozen sherbet containers during production and possibly found its way into ice cream.
Water used to clean equipment, utensils and food packaging wasn’t hot enough.
Plant operators handled dirty surfaces like pallets with “black moldlike residue and red stains” and then touched food surfaces without changing gloves, a violation the FDA also found in 2012.
Employees wore their own shoes into production areas without cleaning requirements.
The plant used hard-to-clean wooden pallets to store and move ingredients.
Equipment wasn’t taken apart to ensure thorough cleaning. For example, a freezer with ready-to-eat ice cream had black “mold-like material” on a gasket.
“In a routine inspection, it’s likely that the FDA representatives may not have included many of these items,” Keener said. “But given the outbreak, the scrutiny is intensified, and every item or infraction, small or large, is noted.”
The FDA described similar problems at the other two facilities in Alabama and Brenham.
Marler said the 2013 findings should have prompted Blue Bell to follow up with tests on surfaces that directly contact food, calling the failure to do so “as bad as it gets.”
His firm is talking to two people who ate Blue Bell and tested positive for listeria, but have not been linked to the outbreak.
The FDA findings could provide fodder for lawsuits and force the company to pay more than medical expenses, because of repeated findings of listeria.
“If one of my clients got sick from ice cream from the Broken Arrow plant in 2015, I would see Blue Bell as liable for punitive damages,” Marler said.
Scott Callahan, a Houston personal injury attorney who has no Blue Bell-related clients, said the company also must worry about lawsuits from stores, retailers and food producers who may have used Blue Bell in their own products.
He called the FDA reports “exactly what we didn’t want to hear. We all know how loyal Blue Bell followers are … The more you trust, the more it hurts when there’s a betrayal.”
Criminal investigation
Legal experts say Blue Bell also could face a criminal investigation. Officials at other food companies, including Colorado’s Jensen Farms, linked to a deadly listeria outbreak from tainted cantaloupes in 2011, have had misdemeanor convictions for unknowingly shipping contaminated products across state lines. Similar convictions were tied to eggs, peanuts and peanut butter.
Troubles for Blue Bell, the third- or fourth-largest U.S. ice cream seller by various measures, became public after random product testing by South Carolina regulators found listeria in an ice cream sample. That set off a flurry of testing by the company and the government. Blue Bell was linked to 10 illnesses in four states since 2010. Three patients who died were sick with other illnesses before eating Blue Bell.
Ice cream traditionally hasn’t been a target for regulators.
But technology is catching up to the industry. Cheaply available whole genome sequencing, which lets scientists decode the DNA of bacteria in a matter of hours, provides conclusive links between illnesses and ice cream.
Industry observers say the Blue Bell case is likely to prompt other frozen dessert manufacturers to re-evaluate safety programs. It’s already bringing new scrutiny from regulators, who discovered listeria in Ohio-based Jeni’s Splendid Ice Creams after testing spurred by the Blue Bell outbreak.