March 2013

According to Herald News reporter, Michael Holtzman, T.A. Restaurant remained closed for a second day Friday and could remain shuttered for the near future while city and state inspectors continue an investigation aimed at eradicating a Salmonella food poisoning problem.  Oddly, although the restaurant has been shuttered, no illnesses have been reported.

According to the Herald News, the Portuguese restaurant on South Main Street, which can hold up to 200 people, has had to throw out all of its food, have its employees tested for Salmonella contamination and disinfect the kitchen and entire premises during the traditionally busy Easter holiday.

T.A. Restaurant, at 408 S. Main St., was opened in 1980 by founder Al Alves, a former longtime city councilor and a mayoral candidate in 2007.

OIG finds that more components of ground beef need to be tested for E. coli, as well as needle tenderized steaks.  OIG also found traceback records were lacking.

The Office of Inspector General (OIG) audited Food Safety Inspection Service (FSIS) to determine how effectively the agency was testing boxed beef items that downstream processors used for ground beef production.

Finding 1: FSIS Needs to Ensure that All Components of Ground Beef are Included in the Agency’s E. coli Testing Program

The OIG found that FSIS needs to re-evaluate its E. coli testing methodology, as it relates to the downstream processing of boxed beef products.  FSIS tests product designated as ground beef or likely to become ground beef, but they do not sample all boxed beef product. Some downstream processors grind such boxes of unsampled cuts of beef without sampling it for E. coli prior to grinding.

Finding 2: FSIS Needs to Improve How It Oversees the Grinding of Bench Trim at Retail Exempt Establishments

Similarly, “retail exempt establishments”—grocery stores, butcher shops, etc.— potentially grind their own ground beef; but unlike Federally inspected plants, FSIS does not sample and test bench trim at these establishments for E. coli. FSIS does have a program for periodically testing the final ground beef products at downstream processors and retail exempt establishments before it enters commerce.

Finding 3: FSIS Does Not Sample Tenderized Meat Products for E. coli Testing

FSIS is not testing tenderized meat products for E. coli despite several recent recalls.

Finding 4: FSIS Needs to Ensure PHIS Contains Accurate Data, so that Establishments are Correctly Sampling Beef for E. coli Testing

FSIS has recently transitioned to their new Public Health Information System (PHIS), which relies, in part; on correct profile information to accomplish such tasks as sending inspectors E. coli sampling requests. However, we found some establishments had incorrect profile information, resulting in incorrect requests for sampling. This profile error caused FSIS not to sample one establishment’s “other ground beef components” for over 4 years. However, FSIS did sample the ground product before it left the plant.

Finding 5: FSIS Needs to Ensure Processors Maintain Sufficient Records for Trace Back and Recall Purposes

Lastly, not all plants we reviewed had adequate records for tracing source material back to the originating slaughter establishment. Such information is crucial during a recall.

And, my favorite part (OIG citing sources):

Online Articles and Blogs: We reviewed sources, such as foodsafetynews.com and meatingplace.com, to stay current on relevant industry issues.

Full Audit Here.

On March 28, 2013, Rich Products Corporation recalled approximately 196,222 pounds of Farm Rich brand frozen chicken quesadillas and several other frozen mini meals and snack items because they might be contaminated with E. coli O121.  USDA/FSIS lists the following places of purchases:

Walmart – Stores Nationwide

Winn-Dixie – Stores in South Florida

And, in Michigan, the following grocery stores: Harding’s Market, Town And Country Market, Hollywood Super Market, Family Fare, Wingert’s Food & Variety Center, Glen’s, Riverside Market, Martin’s Super Markets, Bryan’s Market, Oleson’s Foods, VG’s Grocery, Hollywood Super Market, Shop-Rite, Value Fresh Marketplace, Heartland Marketplace, Vinckier Foods, Village Market Food Center, Neiman’s Family Market, Mcdonald’s Food & Family Ctr., Leppink’s Food Center, Value Center Marketplace, Greenfield Super Market, King Cole Foods, Carrow’s Super Market, Shop – N – Save Food Center, D&W Fresh Market and Glory Supermarket.

Information available to date indicates that consumption of Farm Rich brand frozen food products is one likely source of infection for the ill persons in this outbreak.

Testing conducted by the New York State Department of Health, Wadsworth Center Laboratory, identified the outbreak strain of STEC O121 in an open package of Farm Rich brand frozen chicken quesadillas from an ill person’s home.

On March 28, 2013, Rich Products Corporation recalled approximately 196,222 pounds of Farm Rich brand frozen chicken quesadillas and several other frozen mini meals and snack items because they might be contaminated with E. coli O121.

The CDC reports a total of 24 individuals infected with the outbreak strain of STEC O121 have been reported from 15 states. The number of ill persons identified in each state is as follows: Alabama (1), Arkansas (1), Illinois (1), Indiana (2), Michigan (2), Mississippi (1), New York (3), Ohio (3), Pennsylvania (1), South Dakota (1), Texas (3), Utah (1), Virginia (1), Washington (1), and Wisconsin (2).

78% of ill persons are 21 years of age or younger.  33% of ill persons have been hospitalized. One ill person developed hemolytic uremic syndrome (HUS), a type of kidney failure, and no deaths have been reported.

One of the “Big Six” E. coli strains (O26, O45, O103, O111, O121 and O145) prompts recall.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) was notified of a multistate investigation of E. coli O121 illnesses on March 19, 2013. Food samples were collected from an ill individual in New York as part of this investigation, and tested by the New York State Department of Health Wadsworth Laboratory. At present, the cluster includes 24 cases in 15 states. A sample of a Farm Rich frozen chicken mini quesadilla product from a New York case tested positive for the outbreak strain of E. coli O121. Eight cases in Michigan, Mississippi, New York, Ohio, Pennsylvania, Texas, and Virginia report consuming Farm Rich products. FSIS is continuing to work with federal and state public health partners on this investigation, including the New York State Department of Health, New York State Department of Agriculture & Markets, Food and Drug Administration, and Centers for Disease Control and Prevention.

Rich Products Corporation, a Buffalo, NY firm, is recalling approximately 196,222 pounds of frozen chicken quesadilla and various other heat treated, not fully cooked frozen mini meals and snack items because they may be contaminated with E. coli O121, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.   The following products are subject to FSIS and FDA recall:

  • 7.2-oz. cartons of Farm Rich mini pizza slices with cheese pepperoni and sauce in pizza dough, UPC code 041322376909 with a best by date of May 15 or May 16, 2014.
  • 22-oz. cartons of Farm Rich mini pizza slices with cheese pepperoni and sauce in pizza dough, UPC code 041322356437 with a best by date of May 15 or May 16, 2014.
  • 18-oz. bags of Farm Rich mini quesadillas with cheese, grilled white meat chicken in a crispy crust, UPC code 041322356352 with a best by date of May 14, 2014.
  • 21-oz. bags of Farm Rich philly cheese steaks with cheese, beef & onions in a crispy crust, UPC code 041322356345 with a best by date of May 13, 2014.
  • 22-oz. cartons of Farm Rich mozzarella bites in a pizzeria style crust, UPC code 041322374431 with a best by date of May 19, 2014.
  • 7-oz. cartons of Farm Rich mozzarella bites in a pizzeria style crust, UPC code 041322376916 with a best by date of May 19, 2014.
  • 22-oz. bags of Market Day Mozzarella Bites, UPC code 041322804358 with a best by date of May 12, 2014.

Here are a few earlier E. coli O121 outbreaks:

Dungeness Valley Creamery Raw Whole Milk 2009

Jefferson County Jail Pasteurized American Cheese or Margarine 2007

Utah Wendy’s Restaurant Lettuce 2006

Nebraska Day Care 2006

Connecticut Lake Water 1999

Lisa Kubota of Hawaii News Now reports that investigators with the Hawaii Department of Health are looking into at least nine people have now become ill from E. coli O157:H7.  The confirmed cases consist of three adults and six children. All of them live on Oahu except for a Canadian visitor who spent time on Oahu, but was later diagnosed on the Big Island. Officials are having trouble pinpointing the source of the infections.

Oahu healthcare providers recently received a letter from health officials warning them to be on the lookout for E. coli O157:H7. Around the same time, Dr. James Ireland saw a 67-year-old patient with symptoms like severe diarrhea and abdominal cramps.  Ireland said the man is now recovering after being hospitalized. There have been a total of 11 cases so far this year, including two unrelated to the current cluster. There were 20 last year, 9 the previous year, and 29 in 2010.

According to the state, three of the children in this latest group developed a life-threatening complication called Hemolytic Uremic Syndrome.

Where have I heard this before?

Kaua’i, Hawaii, Restaurants Mesclun Lettuce Mix From an Unnamed, Local Lettuce Farm 2007

A confirmed outbreak of E. coli O157:H7 occurred among people who ate lettuce at restaurants on the island of Kaua’i, Hawaii. Mesclun lettuce mix was named as the vehicle of infection. The lettuce was grown on a local farm near a cattle ranch. Recent rains likely carried runoff from the cattle ranch onto the lettuce crop.

In January 2013 local, state and federal officials announced an outbreak of Salmonella Typhimurium linked to consumption of ground beef produced by Jouni Meats, Inc. and Gab Halal Foods.  Public health investigators used DNA “fingerprints” of Salmonella bacteria obtained through diagnostic testing with pulsed-field gel electrophoresis (PFGE) to identify patients considered to be part of the outbreak. Collaborative investigative efforts indicated that ground beef produced by Jouni Meats, Inc. and Gab Halal Foods were the likely source of the outbreak.

A total of 22 persons infected with the outbreak strain were reported from six states:  Arizona, Illinois, Iowa, Michigan, Pennsylvania, and Wisconsin. Among persons for whom information was available, illness onset dates ranged from December 9, 2012 to February 20, 2013.  Ill persons ranged in age from 2 years to 87 years. Among 14 persons with available information, 7 ill persons were hospitalized.  No deaths were reported.

Initial investigations focused on 7 ill persons in Michigan (6) and Arizona (1) who reported eating at the same restaurant before their illness began.  All seven of these ill persons reported eating raw ground beef kibbeh (a dish typically made of finely ground red meat, usually beef, minced onions, and bulghur wheat) at this restaurant before becoming ill.  An additional 9 ill persons were interviewed and answered questions about foods consumed and other exposures during the week before becoming ill.  Although several of these ill persons reported eating beef prior to becoming ill, a likely source was not identified that linked these illnesses with the illnesses at the restaurant.

On January 24, 2013 Jouni Meats, Inc. recalled approximately 500 pounds of ground beef products.[1]  In the FSIS recall news release announcing this recall, FSIS stated that the investigation identified that raw ground beef was consumed at a restaurant. The products subject to recall are various size packages of ground beef. These products were produced between December 4, 2012 and December 9, 2012, and distributed to a restaurant in Macomb County, Michigan, and sold directly to consumers at Jouni Meats, Inc.  On January 25, 2013 Gab Halal Foods recalled approximately 550 pounds of ground beef products.[2]  The products subject to recall are various size packages of ground beef wrapped in clear plastic. These products were produced between Dec. 4, 2012, and Dec. 10, 2012, and distributed to a restaurant in Macomb County, Michigan, and sold directly to consumers at Gab Halal Foods.

The causal link between our clients’ Salmonella Typhimurium infection and ground beef produced by Jouni Meats, Inc. is clear.  On December 8, 2012 they ate kibbeh prepared at Ikes Restaurant in Sterling Heights, Michigan.  They shared this meal with other family members, who were also diagnosed with Salmonella Typhimurium.

On March 15, 2013 the CDC issued a final notice declaring the outbreak to be over.[3]  Yet, no one has yet to trace the Salmonella Typhimurium to its source.

On Sunday, May 22, 2005, the Department of Health and Environmental Control (DHEC) was alerted to a possible outbreak of foodborne illness centered at Old South restaurant in Camden, South Carolina.  See Final Report, as Attachment No. 1. DHEC officials commenced their investigation the same afternoon.  The outbreak they would soon confirm turned out to be one of the biggest in South Carolina history, sickening over 300 people and killing one man.

The environmental investigation commenced the same afternoon with an inspection of the restaurant.  The facility had closed for the day, and food from the previous week had already been discarded.  Officials returned on May 23 after receiving reports of illness from a family who had received catered food from the previous Thursday’s menu.  This time, environmental staff collected surface swabs and questioned staff and owners about food preparation.  Officials returned again on May 24, and on this date collected samples of raw turkey and eggs from the lot that had been used in meals on May 19 and 22.  The turkey samples were taken for testing to the Food Safety and Inspection Service laboratory in Athens.

Meanwhile, DHEC officials had also begun their epidemiological investigation.  Information, including reports of illness, suggested an outbreak at Old South between and including May 18 and May 22.  Officials developed the following case definition:

A case is an individual with onset of diarrhea with or without fever, vomiting, abdominal cramps, or nausea OR with at least 3 of 4 non-diarrheal symptoms with onset of symptoms after May 18 and who ate at [Old South] between Thursday, May 18 and Sunday, May 22.

For their case-control study, DHEC officials initially analyzed only people who had dined at Old South on May 19.  This analysis revealed that roast turkey was significantly associated with illness, thus prompting second and third studies involving diners from both May 19 and May 22.  Ultimately, the combined results of all studies implicated roasted turkey and biscuits as the likely foods that caused illness.

Laboratory results from the environmental investigation further implicated the roast turkey.  The raw turkey samples that had been taken for testing at the FSIS laboratory returned positive for Salmonella enteritidis.  The Final Report states:

The laboratory results documented the presence of Salmonella enteritidis in the roasted turkey sample collected from the catered event.  All the isolates of Salmonella [including stool samples from “cases”] were indistinguishable by PFGE testing using both the Xba I enzyme and the Bln I enzyme.  The phage typing of nine isolates from the outbreak by the CDC also identified all of them to be identical.

The final circumstances implicating the turkey were discovered by Old South employees during the course of the investigation.  The convection oven  that employees had used to cook the contaminated turkey had malfunctioned, thus preventing the turkey from reaching a temperature sufficient to kill Salmonella.  More specifically, two of the oven’s three heating elements were inoperable during the outbreak exposure period, leaving only one element to warm the oven.

Nonetheless, and by design, the green indicator light on the oven’s control panel remained lit, thus preventing Old South employees from learning of the malfunction.  This was despite the representation in the oven’s manual that, “when lit,” the light “indicates [that] elements are operating.”  With no device to indicate that the oven had malfunctioned, restaurant employees continued to cook the contaminated turkey to an insufficient temperature.

In addition, the oven contained no gauge, display, or device to disclose the oven’s actual temperature, thus creating a variance between the operator-designated temperature and the actual oven temperature.  This variance was not disclosed to the operator, thus producing false, misleading, and confusing information regarding the operation and actual internal temperature of the oven.

The confluence of these several circumstances formed one of the largest outbreaks in South Carolina history.  A total of 304 confirmed and suspected cases were identified during the course of the investigation, and one man died as a result of his infection.  The restaurant remained closed during the investigation, re-opening on June 10, after employees had completed food safety training.

I have known of Mike Taylor since shortly after September 29, 1994.

As Food Safety News reported in “Looking Back: The Story Behind Banning E. Coli O157:H7,” Taylor took the podium that day in San Francisco at the American Meat Institute’s annual convention to make his first, and arguably most significant, speech as the top food safety official at the U.S. Department of Agriculture.

“I am here to talk about change,” began Taylor, who had just become administrator for the USDA’s Food Safety Inspection Service (FSIS), as he looked out over his all-industry audience. “Change in what the public expects when it comes to food safety, change in how we at the FSIS are approaching our job, and change in the demands being placed on all those who produce, process and market meat and poultry for American consumers.”

Taylor explained his belief that the meat industry had an opportunity to move beyond the politics of food safety and find real solutions on the heels of the massive Jack in the Box E. coli O157:H7 outbreak in the Pacific Northwest that had happened a year before.

And then, Taylor uttered a few lines the industry may not have wanted to hear:

“In one critical respect, our inspection program at FSIS does not currently meet the public expectation. There is a gap in our system.  The fact is we do not deal directly enough and scientifically enough with the microbial pathogens that can make people sick.”

“To clarify an important legal point, we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act.”

“We are prepared to use the Act’s enforcement tools, as necessary, to exclude adulterated products from commerce.”

And, with that the world changed.  This seemingly simple change – calling E. coli O157:H7 an adulterant – has over the last 20 years saved countless children from kidney failure and death.  In the long run it has also saved the beef industry millions of dollars – dollars that would have gone into my pocket and the pockets of clients sickened by that deadly bacterium.  And, that has been a very good thing.

Over the last decades I have bumped into Mike at food safety conferences around the world, as he ushered in HACCP in the meat industry, worked on food safety in academia and in his current food safety role at FDA – forcing the industry to think hard about how to prevent another Jack in the Box.  During the run-up to the passage of the Food Safety Modernization Act (FSMA) in 2010, I watched as he deftly helped consumers and industry form partnerships to press for the most comprehensive changes in FDA rules in too many decades.

And, during the last few years I have watched quietly as a few groups raised questions about his integrity, including a petition to President Obama to fire him.

Last Friday I flew from Seattle to spend two hours of Saturday in Boston participating in a panel before some 75 journalists at a session of the annual meeting of the Association of Health Care Journalists.  Along with Mike Taylor and Will Daniels (food safety leader at Earthbound Farms), we discussed why foodborne illness persists as a challenging problem and what consumers, government and industry are doing to prevent it.  Each of us had about 20 minutes each to speak.  The plan then was to open it up for questions.

One of the first questions posed to Mike was not about E. coli O157:H7 or how with a limited budget was the FDA trying to implement FSMA.  The first question was about Mike’s “Monsanto baggage,” specifically whether his past role working on biotechnology-related matters for Monsanto, created a conflict of interest for his current role at FDA as Deputy Commissioner for Foods and Veterinary Medicine.

As the question was being asked, I looked over at Mike and thought to myself, “he simply does not get paid enough to take this.”  But, then again I thought, “heck he is a public servant.  I suppose it simply comes with the territory.”  But, I admit that I was surprised when he responded – politely – and with some details that I do not think he had ever talked about publicly.

Mike explained that his career included time as a staff lawyer at the FDA in the mid 1970s and then practicing law during the 1980s at a law firm that represented Monsanto. He then returned to FDA in 1991 as Deputy Commissioner for Policy under Commissioner David Kessler.  He then led FSIS from 1994 – 1996, where I first heard of him.   In the late 1990s he was employed at Monsanto itself for 16 months, and beginning in 2000 he spent almost a decade in academia doing policy research related to food safety and African agricultural development.  In 2009 he returned to lead the food side of FDA.

Mike was candid with the fact that a history of moving in and out of government through the “revolving door” concerns people and can raise the question of whether his current role at FDA is conflicted by previous private sector roles.  He explained to the questioner, that to guard against such conflicts, the government has clear rules about what a person can and cannot work on under those circumstances, and he follows those rules very carefully.  For example, as Deputy Commissioner for Policy in the mid-’90s, Ethics Counsel said that he could work on general policy matters, such as policies for food labeling, but he was precluded from any involvement in specific product approvals of interest to Monsanto.  So, he explained, among the mythologies surrounding his career was that he was involved in FDA’s decision to approve rBGH, the growth hormone used in dairy cows – he was not.

Surprisingly, Mike was not done setting the record straight.  I say surprisingly, because in all the years I have known him, I had never heard him speak to the issue. He went directly to concerns about his time at Monsanto, and the suggestion one can find readily on the Internet that he is now and always is “Monsanto’s man.”  The questioner was by now a bit out of sorts when Mike said, “nothing is further from the truth.”

Mike explained that while at Monsanto, he worked not as a “lobbyist,” but as the head of an internal think tank and as a policy advisor to senior management.  In this role, he strongly advised Monsanto to drop its opposition to the labeling of biotech foods and to engage its external stakeholders in a more respectful and transparent way.  Monsanto did not take his advice.  He explained that he left Monsanto when it became clear that he would be unable to have any real impact.  He realized that perhaps he was better suited to addressing issues that interested and concerned him from a more “objective platform,” which is why he spent the next decade in universities working primarily on policies affecting agriculture in Africa and food safety as a global public health and food system issue.

Mike explained that he did not feel conflicted by his past experience with biotechnology policy, but he understood concerns about it and thus that the “baggage” he carries is real to some.  That is why he has removed himself from participation in deliberations and decision making on all biotech-related issues that arise in the foods and veterinary medicine programs at FDA even though he has thoughts on it.

Mike began to finish his answer with a bit of introspection – with the tone of someone at both the height of a career and also looking back.  He said that he did his work at FDA every day with only one interest in mind, which is doing everything he can to fulfill the mission given by Congress to protect consumers and public health.  He does this by working as closely as he can with stakeholders and partners, recognizing the need to find practical solutions that consider the wide range of perspectives on FDA issues held by the many people who care deeply about what FDA does.  He said his only goal is to fully implement FSMA and address the range of other food safety, nutrition, and animal health issues central to the mission at FDA.

This week, I had time to do just a little research.  Frankly, it does not take long to find where Mike addressed biotech issues in writing on several occasions. This included a 2003 commentary in the Journal Nature Biotechnology (Vol. 21, No. 8, Aug. 2003) in which he criticized the aggressive approach the U.S. government and biotechnology industry were taking to promote biotech crops overseas, including in Africa, and argued that “the United States should be on the side of empowering choice” in the adoption of biotechnology, “in whatever way works in any given country,” including through labeling.  He also called in that commentary for policy change aimed at strengthening pre-market oversight of biotech foods.  In another article (Taylor and Cayford, American Patent Policy, Biotechnology, and African Agriculture: The Case for Policy Change, Harvard Journal of Law & Technology (Vol. 17, No. 2, Spring 2004), he argued, in the interest of African food security, for changes in U.S. patent policy and international patent agreements that would reduce the control Monsanto and other biotech companies could exercise over biotech crop improvements that could genuinely benefit food security. To me these are not exactly the perspectives of someone looking out for Monsanto’s interests.

As the questions and answers wound down last week, I leaned over and asked Mike if he was up for a cup of coffee.  Over a bad cup, I asked him why after all the years of being called “Monsanto’s Man” did he feel the need to say anything?  He looked a bit perplexed at my question and said:

We’d all like to be judged for what we actually do rather than half-truths and myths on the Internet.  I know I won’t satisfy those who object in principle to people working on FDA-related matters in both the public and private sector, or who think the rules governing these situations are not adequate, or who don’t like the policies FDA has made whether I worked on them or not.  I fully understand and respect that point of view.  About all I can say is that people in positions like mine work in the open, under the guidance and scrutiny of their bosses and many others, and I have always done my best to fulfill my responsibilities to FDA and its public health mission.

I am not sure we can ask more of Mike or anyone in government.

Food Chemical News reports that the preventive controls proposal that FDA sent to the White House Office of Management and Budget in November 2011 would have required food companies to conduct environmental and finished product testing, maintain supplier verification programs, and track consumer complaints. But the OMB struck the requirements and those documents were recently posted online – Transparency is good, but it would be good to get an explanation for the deletions.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Proposed Rule); Publication Date: January 16, 2013

The September 30, 1993, Executive Order 12866 (Regulatory Planning and Review) sets forth the principles and requirements for the Federal regulatory process. Under section 6(a)(3)(E) of the Executive Order, for “significant regulatory actions,” Federal agencies must make certain information available to the public after publication of the regulatory action in the Federal Register.

Pursuant to the Executive Order for significant regulatory actions, FDA has attached in this docket the following information:

1) A copy of the draft regulatory action as submitted to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) for review, including materials required by the Executive Order that accompanied the draft (TAB A, comprised of two documents – one and two);

2) The substantive changes between the draft submitted to OIRA for review and the regulatory action subsequently published are shown in track changes text review, including materials required by the Executive Order that accompanied the draft (TAB B, comprised of four documents – one, twothree and four); and,

3) A copy of the final regulatory action as published in the Federal Register, and a final version of the materials required by the Executive Order that accompanied the draft (TAB C, comprised of two documents – one and two).

Hey OMB, why were these provisions cut out?

Product and environmental testing reveals where gaps are in a HACCP plan.  Testing is never foolproof, but only fools do not test.  Supplier verification programs make sense too.  A manufactured food product is only as safe as its inputs.  And, finally, consumer complaint tracking is really an early warning system that helps identify food safety problems before they become a food safety outbreak.

It begs the questions:  Who at OMB made these cuts?  And, who at OMB is the expert on food safety?