June 2016

tofu-featuredThe U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Wa Heng Dou-Fu & Soy Sauce Corporation doing business as Wa Heng Dou-Fu & Soy Sauce International Enterprises (Wa Heng) and the firm’s co-owners, Peng Xiang “Martin” Lin and Yuexiao “Opal” Lin, to prevent the distribution of adulterated and misbranded soy products, the Department of Justice announced today.

The Department filed a complaint in the Eastern District of California on June 17, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that the defendants violated the Food, Drug and Cosmetic Act by causing food that is held for sale after shipment of one or more of its components in interstate commerce to become adulterated and misbranded. According to the complaint, the defendants have an extensive history of operating their food manufacturing facility under insanitary conditions, failing to follow current good manufacturing practice requirements and misbranding their food products.

“The American public deserves to be assured that companies and individuals preparing and distributing food subject to the Food, Drug and Cosmetic Act are complying with federal law,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to ensure a safe food supply.”

As detailed in the complaint, the company receives, prepares, processes, manufactures, packs, labels, holds and distributes soy products including fried tofu, firm tofu, seasoned tofu and soy drinks. The complaint alleged that Martin Lin’s responsibilities include the firm’s daily operations, raw material purchases, facility and equipment maintenance and production schedule and that Opal Lin’s responsibilities include training employees and overseeing employee performance.

In conjunction with the filing of the complaint, the defendants agreed to settle the case and to be bound by a permanent injunction that requires Wa Heng to cease all food preparation, manufacturing and distribution. If the defendants seek to resume preparing, manufacturing and distributing food, they must implement remedial measures set forth in the injunction, notify FDA of the measures taken, and receive written notification from FDA that they appear to be in compliance with the remedial requirements set forth in the injunction and the Food, Drug and Cosmetic Act.

According to the complaint, the defendants had a history of repeated violations. A 2015 inspection by FDA documented that the defendants failed to take reasonable precautions to ensure that production procedures do not contribute to contamination from any source. For example, as alleged in the complaint, FDA observed at least three employees spraying pressurized water from a water hose onto the production area floor, where FDA isolated Salmonella Havana, causing water to splash from the floor onto uncovered tofu and onto food contact surfaces, such as tofu presses and a filtration table. This was a repeat observation from the FDA’s 2012 inspection. In addition, FDA observed employees touching the bottoms of buckets and crates that had been on the floor and then touching tofu. The hand wash sink in the production room had no hot water because the valve had been turned off and the sink was inaccessible due to crates in front of it. This was also a repeat observation from the 2012 inspection.

According to the complaint, the most recent inspection also found that the defendants failed to maintain equipment and utensils in an acceptable fashion through appropriate cleaning and sanitizing. FDA observed spray hose nozzles, air valves, water valves and light switches that contained heavy residue, as well as a tofu cutting knife that was placed on top of a tofu press with greenish-brown buildup and then used to slice tofu.

Further, the complaint alleged that during the 2015 inspection, FDA conducted environmental sampling of the facility and five subsamples tested positive for pathogenic Salmonella Havana. According to the complaint, the positive samples were taken from, among other places, a floor drain near a cooking tank, a caster wheel on a cart carrying tofu and the floor between the packing and processing rooms. As noted in the complaint, FDA isolated a nearly identical strain of Salmonella Havana during its 2011 and 2012 inspections.

During the 2015 inspection, FDA also collected samples of the defendants’ product labeling. The complaint alleges that the defendants’ products are misbranded because, among other things, some of the firm’s soy products fail to include a label containing an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

“Firms and individuals that violate federal food safety regulations pose a danger to public health,” said Acting U.S. Attorney Phillip A. Talbert of the Eastern District of California. “The Department will not hesitate to hold companies and individuals accountable in order to protect the American people from adulterated food.”

The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney Colleen Kennedy of the Eastern District of California and Associate Chief Counsel for Enforcement Charlotte Hinkle of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.

ucm508640General Mills announced today a voluntary national recall of four specific flavors of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars. The recall is being issued as part of sunflower kernel supplier SunOpta’s ongoing national recall for the potential presence of Listeria monocytogenes. General Mills has not received any direct consumer reports of confirmed illnesses related to this supplier issue.
The four flavors of Nature Valley bars that are part of the recall were distributed to retail establishments throughout the United States.  Consumers are asked to check their pantries and dispose of the products affected by this recall, regardless of when they were purchased or what date is on the package.

This recall only affects four flavors of Nature Valley’s nearly 40 different products. Nature Valley’s other products are not affected by this recall.

Other General Mills products that use sunflower kernels have not been impacted.  SunOpta announced the expansion of their sunflower kernel recall yesterday (June 1, 2016) which impacted these four specific flavors of Nature Valley bars.

This voluntary recall includes the following products currently in stores or consumers’ pantries:

Nature Valley Protein Chewy Bar -Honey, Peanut & Almond with Pumpkin Seeds – 5 count
Package UPC:  000-16000-47196

Nature Valley Protein Chewy Bar-Peanut, Almond & Dark Chocolate – 5 count
Package UPC: 000-16000-45724

Nature Valley Simple Nut Bar – Roasted Peanut & Honey – 4 count
Package UPC: 000-16000-46475

Nature Valley Simple Nut Bar – Roasted Peanut & Honey – 16 count
Package UPC: 000-16000-41308

Nature Valley Simple Nut Bar – Almond, Cashew & Sea Salt – 4 count
Package UPC: 000-16000-46474

Nature Valley Simple Nut Bar-Almond, Cashew & Sea Salt – 25 count
Package UPC: 000-16000-41301

For the last 20 plus years at food safety conferences around the world, I have primarily pitched the moral reason not to poison customers.  With 48,000,000 sickened each year, 125,000 hospitalized and 3,000 deaths in the U.S., I have had far too many examples to choose from.  With the economic losses to the victims and their families being nearly $100,000,000,000 yearly, foodborne illness clearly impacts people, and in and of itself is reason enough to focus on food safety.

However, if the above statistics do not motivate a CEO to invest in food safety, the below graph certainly should:

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With several food safety lapses in 2015 and resulting outbreaks of E. coli (some never reported), Salmonella and Norovirus, Chipotle has seen its stock price fall from over $750 to below $400 – that is serious money.  Paying attention to detail and investing in food safety likely would have prevented this loss as well as the various stockholder lawsuits and a criminal investigation.

So, pick the moral or business reason to not sicken customers – hopefully both.

One, note – the other costs that are not even counted above include recall cost (can be massive) and other economic losses throughout a chain of production.

I am off to the other Washington this week to teach a class on business ethics, give a speech to a couple of dozen congress members, and meet with some FDA, FSIS and White House staffers – wish me luck.

linfufood$819249National Frozen Foods Corporation is voluntarily recalling a limited quantity of Not-Ready-To Eat frozen green peas and frozen mixed vegetables because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeriainfection can cause miscarriages and stillbirths among pregnant women.

This press release does not include recalled products distributed to food service accounts in bulk containers and recalled products distributed to food service accounts in Canada and Japan.

The frozen green peas and frozen mixed vegetables are being recalled as a precaution with the health and safety of consumers as top priority. The recall was the result of a sample tested by the company which revealed that the finished products may potentially be contaminated with the bacteria. The Food and Drug Administration has been made aware of this recall. There have been no reported illnesses attributed to the recalled items to date.

The products being recalled listed below were distributed in retail stores nationwide between September 2, 2015 and June 2, 2016.

The recalled items can be identified by the date codes printed on the back of the retail sized bag or the side of the master case. Link to Recall List.

images.washingtonpost.comThe Willamette Week reports that the Oregonian has begun rebuilding its staff—it welcomed three new reporters in the past couple of weeks—and newsroom morale after years of buyouts.

But one feel-good initiative, a May 31 cake-and-coffee gathering to recognize outstanding staff performance, went awry.

The Multnomah County Health Department is now investigating a potential norovirus outbreak after at least 14 people came down with stomach pain and severe diarrhea after the event.

The county sent samples of the cake to a laboratory for testing, according to health department spokeswoman Julie Sullivan-Springhetti. “One person did test positive to norovirus,” Sullivan-Springhetti says, referring to the stomach-flu-like ailment sometimes called “cruise-ship disease.”

As The Oregonian has reported, norovirus and other food-borne disorders are increasingly common.

“It was definitely unfortunate,” Oregonian Editor Mark Katches says in an email. “But it won’t stop us from doing these types of celebrations in the future.”

hat-trick_square_400x400‘A hat-trick or hat trick in sports is the achievement of a “positive” feat three times in a game.’

Campylobacter:  Solana Health Department reports that a Mexican restaurant in Fairfield, California has been closed since Wednesday while an investigation continues into 32 confirmed cases of Campylobacter infection.

Alejandro’s Taqueria on Texas Street in downtown Fairfield is to remain shut down until revised operations meet with approval from county health officials. County health officials are not certain what food item might have caused the illnesses. They are still checking samples of cooked foods taken from the restaurant on June 8 and also continuing to investigate the reports of those sickened.

E. coli: The Colorado Department of Public Health and Environment are investigating an outbreak of E. coli O157:H7 in Aurora. The outbreak was reported at Pho 75, an Aurora restaurant located at 2050 South Havana Street.

So far, four ill people have been identified, but as with any outbreak, it is possible that there are more sick than reported, as some might not go to the doctor. One of the four ill was hospitalized.

The Tri-County Health Department is working with the restaurant during the investigation. Pho 75 voluntarily closed yesterday. According to the state, typically when a restaurant closes in this kind of situation, a list of requirements must be met before they are allowed to reopen.

Salmonella:  Ector County Texas Health Department announced the total number of people who have lab-confirmed cases of Salmonella has increased by one, bringing the total number to three.  There are also 24 probable cases. The restaurant where the people got the illness was Ajuua’s Mexican Restaurant.

The restaurant, at the request of the health department, closed their doors Monday after complaints were made by residents who said they got sick after eating at the restaurant on June 1. The investigation started around 4:15 p.m. June 3 after officials with the health department got a call saying 10 people had gotten sick after eating at Ajuua’s.

General_Mills-512x384The CDC reports that 38 people infected with the outbreak strain of E. coli O121 have been reported from 20 states. Illnesses started on dates ranging from December 21, 2015 to May 3, 2016. Ten ill people have been hospitalized. In its investigation, CDC learned that some people who got sick had eaten or handled raw dough.

FDA’s traceback investigation determined that the raw dough eaten or handled by ill people or used in restaurant locations was made using General Mills flour that was produced in the same week in November 2015 at the General Mills facility in Kansas City, Missouri. Epidemiology and traceback evidence available at this time indicate that General Mills flour manufactured at this facility is the likely source of the outbreak. On June 10, 2016, FDA whole genome sequencing on E. coli O121 isolates recovered from an open sample of General Mills flour belonging to one of the consumers who was sickened was found to be closely genetically related the clinical isolates from human illnesses. The flour came from a lot that General Mills has recalled.

On May 31, 2016, following a conference call among FDA, CDC and the firm, General Mills conducted a voluntary recall of flour products produced between November 14, 2015 and December 4, 2015. Recalled products are sold in stores nationwide or may be in consumers’ pantries and are sold under three brand names: Gold Medal flour, Signature Kitchens flour and Gold Medal Wondra flour. The varieties include unbleached, all-purpose, and self-rising flours.

General Mills also sells bulk flour to customers who use it to make other products. General Mills has contacted these customers directly to inform them of the recall. FDA is working with General Mills to ensure that the customers have been notified, and to evaluate the recall for effectiveness. Because of legal restrictions on commercial confidential information, FDA is not at this time authorized to release the names of these customers or the products they make with the flour.

Flour has a long shelf life, and bags of flour may be kept in peoples’ homes for a long time. Consumers unaware of the recall could continue to eat these recalled flours and potentially get sick. If consumers have any of these recalled flours in their homes, they should throw them away.

Recalled products are currently sold in stores or may be in consumers’ pantries and are sold under three brand names: Gold Medal Flour, Signature Kitchens Flour, and Gold Medal Wondra flour. The recalled products were sold nationwide and include unbleached, all-purpose, and self-rising flours varieties.

The specific products in the recall include:

13.5 ounce Gold Medal Wondra Flour

Package UPC 000-16000-18980
Recalled Better if Used by Dates 25FEB2017 thru 30MAR2017

2 lb. Gold Medal All Purpose Flour

Package UPC 000-16000-10710
Recalled Better if Used by Dates 25MAY2017KC thru 03JUN2017KC

2lb Gold Medal Self-Rising Flour

Package UPC 000-16000-11710
Recalled Better if Used by Dates 23AUG2016KC

10lb Gold Medal All Purpose Flour

Package UPC 000-16000-10410
Recalled Better if Used by Dates 02JUN2017KC,  03JUN2017KC

5lb Gold Medal All Purpose Flour

Package UPC 000-16000-10610
Recalled Better if Used by Dates 25MAY2017KC, 27MAY2017KC thru 31MAY2017KC, 01JUN2017KC, 03JUN2017KC thru 05JUN2017KC, 11JUN2017KC thru 14JUN2017KC

5lb Gold Medal Unbleached Flour

Package UPC 000-16000-19610
Recalled Better if Used by Dates 25MAY2017KC, 27MAY2017KC, 03JUN2017KC, 04JUN2017KC

10lb Gold Medal All Purpose Flour- Banded Pack

Package UPC 000-16000-10410
Recalled Better if Used by Dates 03JUN2017KC, 04JUN2017KC, 05JUN2017KC

5lb Signature Kitchens All Purpose Flour Enriched Bleached

Package UPC 000-21130-53001
Recalled Better if Used by Dates BB MAY 28 2017

5lb Signature Kitchens Unbleached Flour All Purpose Enriched

Package UPC 000-21130-53022
Recalled Better if Used by Dates BB MAY 27 2017

 

Alejandros-TaqueriaSolano Health Department reports that a Mexican restaurant in Fairfield, California has been closed since Wednesday while an investigation continues into 32 confirmed cases of Campylobacter infection. Alejandro’s Taqueria on Texas Street in downtown Fairfield is to remain shut down until revised operations meet with approval from county health officials.

According to Deputy Health Officer Dr. Michael Stacey, Solano County has received an unusually high number of reports of abdominal illness this month.

“There have been increased reports of laboratory-confirmed campylobacteriosis since the beginning of June,” he stated. “So far, 32 campylobacter cases have been reported to us this month, almost double the number of reported cases that we had for the whole month of June in 2015.” A number of those people said they had eaten at Alejandro’s from May 26-29, according to health department reports, making the timeline for potential illness a few days before and after that period.

County health officials are not certain what food item might have caused the illnesses. They are still checking samples of cooked foods taken from the restaurant on June 8 and also continuing to investigate the reports of those sickened.

According to a health alert sent out June 6 by the Solano County Public Health Department, the most common sources of Campylobacter are the infected feces of animals or people, unpasteurized milk, and contaminated poultry, meat, water or other food products.

Infection with Campylobacter bacteria typically causes diarrhea, cramping, abdominal pain, and fever within two to five days after exposure to the organism. The diarrhea may be bloody and can be accompanied by nausea and vomiting. The illness typically lasts about one week.

Some infected people do not have any symptoms but can transmit the illness to others. In those with compromised immune systems, Campylobacter occasionally spreads to the bloodstream and causes a serious life-threatening infection.

Screen Shot 2016-06-09 at 10.01.59 PMThe March 14, 2016 inspection seemed to be a standard follow-up of an inspection by the Washington State Department of Agriculture (WSDA) on September 1, 2015.  Here is also an inspection by WSDA on December 14 and 15, 2014.

Setting aside what food safety violations that were found on each of the inspections, the most disturbing part of the 2016 “inspection” were the refusals by the company to produce documents regarding “consumer complaints, recalls, pest control, sanitation, environmental and finished product sample results, interstate shipping documents, receiving documents and metal detection logs.”  CFR management also refused to allow the FDA to take pictures, “citing proprietary concerns and company policy.”  I highlight the refusals in pink on the 2016 document for easy reference.

I’m sorry, but I am stumped here.  How is it that a company that is producing food for interstate and international shipment can refuse FDA inspector’s legitimate requests for documents that would in fact document food safety?

And, then on on May 3, 2016 the CDC, FDA and others weighed in.

Since March 2016, CDC has been collaborating with public health officials in several states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Listeria monocytogenes infections (listeriosis).

Eight people infected with the outbreak strains of Listeria have been reported from three states since September 13, 2013. All eight people were hospitalized, including one from Maryland and one from Washington who died.

Epidemiologic and laboratory evidence available at this time indicates that frozen vegetables produced by CRF Frozen Foods of Pasco, Washington and sold under various brand names are one likely source of illness in this outbreak. Investigations are ongoing to determine if food sources used to manufacture CRF Frozen Foods products could explain some of the illnesses.

On April 23, 2016, CRF Frozen Foods recalled 11 frozen vegetable products because they may be contaminated with Listeria. On May 2, 2016, CRF Frozen Foods expanded the initial recall to include all organic and traditional frozen vegetable and fruit products processed in its Pasco, Washington facility since May 1, 2014. Approximately 358 consumer products sold under 42 separate brands were recalled.

Our ongoing audit of FDA’s food recall program found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply. Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.

We suggest that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.

Here is the full report.

Screen Shot 2016-06-09 at 9.16.29 AM

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FDA’s response.