If you try sometimes, you’ll get what you need: FDA says can’t have it both ways on food safety

Two of the things growers and shippers want to see in new federal food safety rules — flexibility and simplicity — are mutually exclusive according to officials from the Food and Drug Administration.

mick.taylorCoral Beach of The Packer writes the more flexible the rules, the more complicated they have to be. That was the message from FDA’s top food safety staff during a Nov. 21 session in Florida where they fielded questions on proposed rules required by the Food Safety and Modernization Act.

Mike Taylor (right, not exactly as shown), FDA deputy director of foods, and Samir Assar, director of produce safety at the FDA’s Center for Food Safety and Applied Nutrition, also said time has not been on the agency’s side in terms of developing the rules.

“It’s an incredibly rapid, very tight time frame were on,” Taylor said, adding that a court order requires the agency to publish the final rule for produce in October next year.

Taylor and other federal officials spent about 90 minutes reviewing the proposed rules and revisions before taking questions during the session, which was sponsored by the Florida Agriculture Department. It was the fifth such state session Taylor and the others have attended since Nov. 6.

(Terrible pretend playing in the video below; and this guy interviewed Nixon.)


FDA reinventing selves to keep food safe

Michael R. Taylor, the U.S. Food and Drug Administration’s Deputy Commissioner for Foods and Veterinary Medicine and Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy write Congress enacted the FDA Food Safety Modernization Act (FSMA) in response to dramatic changes over the last 25 years in the global food system. It grew out of an understanding that foodborne illness is both a significant public health problem and a threat to the economic well-being of the food schaffner.facebook.apr.14system. And FSMA was embraced by a public whose confidence in the food system was being eroded by a series of foodborne outbreaks.The law directs a comprehensive overhaul of our food safety system, using three broad themes:

Advancing Public Health – by focusing on prevention of food safety problems through broad, consistent industry implementation of modern preventive practices.

Leveraging and Collaborating – by working in close collaboration with other government agencies (federal, state, local, tribal and foreign), the food industry and other stakeholders to make the best use of all available food safety resources.

Strategic and Risk-Based Industry Oversight – including clear FDA guidance on standards; outreach and technical assistance to facilitate voluntary compliance; and the use of adaptable, risk-based inspection and compliance strategies that focus on public health outcomes and the effectiveness of overall systems of prevention.

Since January 2013, we have proposed seven new rules to establish the comprehensive framework of modern, prevention-oriented standards mandated by FSMA, covering the production and transportation of human and animal foods, whether produced in the U.S. or overseas. There is a lot of work to do to get these standards right, and we are very focused on that work. At the same time, however, we must be laying the foundation for the next phase: effective and efficient implementation of the new standards. This requires fundamentally new approaches to collaboration and oversight to achieve high rates of compliance with FSMA’s prevention standards. And from a public health and public confidence standpoint, this is where the rubber meets the road.

We are thus pleased to be sharing with our partners and stakeholders a document that captures in broad, high-level terms our current thinking on strategy and guiding principles for implementing the produce safety rule, the preventive controls rules, and FSMA’s new import tool kit, after the final FSMA rules are issued in late 2015 and early 2016. We are making this available as the springboard for discussion with the entire food safety community.  And we know discussion is needed, because the strategy that will make FSMA a success requires significant change in how we at FDA do our work and how we work with our partners.

For example, FSMA calls for a national integrated food safety system that builds on FDA’s longstanding collaboration with state governments on food safety inspection and compliance, but we must take that collaboration to a new level, especially when it comes to the new and unique challenge of implementing the produce safety rule. We aspire to rely heavily on state agriculture departments and other state and tribal departments with analysison-farm food safety responsibility, taking advantage of their food safety commitment, their knowledge of local conditions and practices, and their local presence to deliver training, technical assistance and compliance oversight. But we have to work closely with our state partners to convert this aspiration to reality. That work includes finding the funding they will need to play an expanded role on produce safety and other areas of FSMA implementation.

FSMA is also helping drive internal governance change at FDA to be sure that all headquarters and field elements of our program are working seamlessly and efficiently to achieve our public health goals. You may have seen the memorandum that Commissioner Margaret Hamburg issued in February 2014 directing a more vertically integrated alignment of the program centers and the Office of Regulatory Affairs (ORA) working in particular areas, such as food safety and drug quality. This is aimed at increasing specialization across FDA, including the programs as well as frontline investigators and compliance officers. It is also intended to streamline interactions between ORA and Center experts so we can devise effective oversight plans, make well-informed judgments during inspections, and achieve timely corrective action when needed to protect consumers.

As the deputy commissioners for Foods and Veterinary Medicine (FVM) and Global Operations (GO), we share leadership responsibility, on the Commissioner’s behalf, for implementing these changes within FDA. To facilitate our efforts and share responsibility, we have created a new FVM Governance Board, which we co-chair and which includes as members: Michael  Landa, director of the Center for Food Safety and Applied Nutrition (CFSAN); Bernadette Dunham, director of the Center for Veterinary Medicine (CVM); and Melinda Plaisier, associate commissioner for Regulatory Affairs (ORA). This Board will help ensure that CFSAN, CVM, and ORA partner fully on major strategic decisions that affect successful implementation of FSMA’s new prevention paradigm.

This is the commissioner’s vision of an agency that works seamlessly across borders, both internal and external, when it comes to protecting public health.

Finally, the work of developing detailed plans for implementing the produce safety and preventive controls rules and the new import safety system is being done by teams of FDA employees overseen by the FSMA Operations Team Steering Committee. This steering committee is led by Roberta Wagner, CFSAN deputy director for regulatory affairs, and Joann Givens, ORA Central Region, acting regional food and drug director, and it will play a key role in the dialogue we will be seeking with our government partners and stakeholder community on our FSMA implementation plans. You’ll be learning about this team’s crucial leadership role in an upcoming FDA Voice blog.

We need your engagement in this important work. Together, we can build a modern food safety system that works well for the food system and for the consumers we all serve.

15 sick; food safety failures, arrogance in Canada’s E. coli O157 outbreak

In mid-1994, Michael Taylor was appointed chief of USDA’s Food Safety and Inspection Service.  On Sept. 29, 1994, USDA said it would now regard E. coli O157:H7 in raw ground beef as an “adulterant,” a substance that should not be present in the product. By mid-October, 1994, Taylor announced plans to launch a nationwide sampling of ground beef to assess how much E. coli O157:H7 was in the marketplace. The 5,000 samples would be taken during the year from supermarkets and meat processing plants “to set an example and stimulate companies to put in preventive measures.” Positive samples would prompt product recalls of the entire affected lot, effectively removing it from any possibility of sale.
That’s the long-winded version for what a USDA official said in a 1994 television interview: we’ll stop blaming consumers when they get sick from the food and water they consume.

With 15 confirmed E. coli O157 illness across Canada linked to XL Foods in Alberta, the company laid off 2,000 employees Saturday, then called 800 back to work so they can get on with re-opening the plant the Canadian Food Inspection Agency closed Sept. 27, 2012.

Gerry Ritz, Minister of Agriculture said, “My thoughts are with the workers and the community affected by this private sector business decision.”

He didn’t say anything about the sick people, other than platitudes about how “we won’t compromise when it comes to the safety of Canadians’ food.”

But there’s lots of others eager to blame consumers, almost 20 years after the Jack-in-the-Box outbreak sparked Taylor’s actions.

Dr. Jean Kamanzi, who used to be a director at the Canadian Food Inspection Agency and now is responsible for food hygiene in Africa for the United Nations Food and Agriculture Program said any E. coli bacteria in the meat could be rendered harmless if it’s cooked to a safe internal temperature — 71 degrees Celsius.

“The meat we’re now throwing into the garbage, which contains this so-called E. coli, if you take it and cook it like you’re supposed to there’s no problem. It’s edible. These are good proteins. … “This is collective hysteria. We’re throwing away meat, we’re throwing everything away. Maybe we’re in a rich country and we can allow ourselves the luxury of not taking any risks at all — but these risks, we take them every day when we touch meat.”

Jean’s point about this being a problem for wealthy countries is taken, but it’s not collective hysteria, especially to the people who got sick.

Dr. Sylvain Quessy, who teaches meat hygiene and is the vice-dean at the faculty of veterinary medicine at the University of Montreal, says that, from a statistical standpoint, the number of illnesses associated with the type of E. coli in the XL Foods safety investigation — 15 Canadian cases in a month — is not especially alarming.

“Everyone’s worrying about a number of cases that is not excessive compared with what you’d normally expect. What we’re telling people — it’s as true now as it was before — is you need to cook your meat properly. (And) wash your hands and wash the things the raw meat touched and you eliminate the danger.”

Sylvain Charlebois of the University of Guelph, said, “If you cook your meat correctly and thoroughly, you will likely eliminate all risks. I would argue that if we educate the public, and we make sure that consumers know what to do with their beef products, you will likely eliminate most of the risks.”

And I thought Australia was stuck in the 1980s.

The feds responded, “despite the fact that proper cooking and handling of food helps prevent illness, the best way to protect yourself is to not eat recalled products at all.”

Taylor did what he did back in 1994 based on the extreme virulence of shiga-toxin producing E. coli like O157:H7, the underestimated risk of cross-contamination, and that food safety isn’t simple, it’s complex. Consumers and food service workers have a role, but these other factors mean loads must be reduced throughout the system.

And this is without getting into the risk of needle- or blade-tenderized steaks and roasts, which sickened some of the people in the XL outbreak.

Just cook it doesn’t cut it. The U.S. meat industry has been told this for years. Why doesn’t Canada?

And although officials insist it was planned months before the XL fiasco, CFIA is going to be audited later this month by the U.S. Department of Agriculture for the first time in three years.

Canada exported more than $4 billion worth of beef and pork in 2010, much of it to the United States.

The final USDA report from its 2009 CFIA audit found weaknesses in the ability of Canadian inspectors to verify consistent sanitation and hazard protection in some slaughter plants, but noted the agency was planning to take action to deal with the shortcomings.

It also said agency inspectors and supervisors were routinely not following procedures for monitoring sanitation controls as laid out by the CFIA.

“Principal areas of weakness included the inability of inspection personnel to implement consistent sanitation and hazard analysis and critical control points verification procedures,” says the report, which was sent to the CFIA in October 2010.

“And, more significantly, (there is) the lack/loss of consistent supervisory reviews to identify weaknesses in inspection performance when it occurred.”

The report did find that the Canadian inspection system adequately verified testing for generic E. coli.

This banter is of no use to people sickened in the outbreak.

Norovirus confirmed in Michigan hockey rink barfing outbreak

Wayne County health officials confirmed today that the outbreak of vomiting and diarrhea that sent nearly 100 people to area hospitals Sunday from a hockey tournament at the Taylor Sportsplex was caused by a fast-spreading norovirus.

The Detroit Free Press reports the Sportsplex reopened Thursday, and "the majority of individuals who suffered norovirus symptoms have recovered or have nearly recovered — they’re showing the classic progression of the virus running its course." Wayne County Department of Health spokeswoman Mary Mazur said.

The city-owned building was shut down Sunday night so that water and air testing could be performed, and the entire building has been disinfected, Mazur said Friday. It had been scheduled to reopen Wednesday, but managers of the facilities "decided to err on the side of caution" and gave an additional day to the clean-up and testing, she said.

Top 10 reasons telling people to ‘just cook it’ sucks as a food safety strategy

About 18 months after the 1993 Jack-in-the-Box E. coli O157:H7 outbreak, I, the erstwhile graduate student, gave a talk to a bunch of food safety types from government and industry. I showed a clip from ABC’s 20/20 television program about a family fighting for regulatory change, and many in the audience laughed at the family when their kitchen was shown. Audience members commented that the consumers were sloppy in their cooking and of course they got sick, and if only they would cook hamburger properly E. coli O157:H7 wouldn’t happen.

I thought the response of the audience was sort of appalling.

In mid-1994, Michael Taylor was appointed chief of USDA’s Food Safety and Inspection Service.  On Sept. 29, 1994, USDA said it would now regard E. coli O157:H7 in raw ground beef as an “adulterant,” a substance that should not be present in the product. By mid-October, 1994, Taylor announced plans to launch a nationwide sampling of ground beef to assess how much E. coli O157:H7 was in the marketplace. The 5,000 samples would be taken during the year from supermarkets and meat processing plants “to set an example and stimulate companies to put in preventive measures.” Positive samples would prompt product recalls of the entire affected lot, effectively removing it from any possibility of sale.

That’s the long-winded version for what a USDA official said in a 1994 television interview: we’ll stop blaming consumers  when they get sick from the food and water they consume.

But the just-cook-it crowd persisted. And still does today.

A couple of weeks ago, while announcing a ground beef recall in Colorado, the U.S. Department of Agriculture’s Food Safety Inspection Service stated in a release,

FSIS would like to remind consumers of the importance of following food safety guidelines when handling and preparing raw meat. Ground beef should be cooked to a safe minimum internal temperature of 160° Fahrenheit.

I would like to remind FSIS that it ain’t so easy to handle contaminated ground beef and not spread it around a home or food service kitchen.

Jim Marsden, a former vp at the American Meat Institute and now a professor at Kansas State University, wrote in his meatingplace.com blog last week, the top-10 reasons “just cook it” does not, and will not, work.

1. E. coli O157:H7 is a unique pathogen. The levels of this organism necessary to cause infection are very low.

2. The severity of the disease E. coli O157:H7 can cause, especially in children is devastating.

3. In many cases, parents order hamburgers for their children and rely on restaurants to cook them properly.  In restaurants, parents really have no control over whether the hamburgers they order are sufficiently cooked to eliminate possible contamination from E. coli O157:H7.

4. If consumers unknowingly bring this pathogen into their kitchens, it is almost impossible to avoid cross contamination. Even the smallest amount of contamination on a food that is not cooked can cause illness. Many of the reported cases of E. coli O157:H7 have involved ground beef that was clearly cooked at times and temperatures sufficient to inactivate E. coli O157:H7.  Some other vector, i.e. cross contamination was probably involved.

5. Even if consumers attempt to use thermometers to measure cooking temperature, it is difficult to properly measure the internal temperature of hamburger patties. They would have to use an accurate thermometer and place the probe exactly into the center of the patty. In addition, the inactivation of E. coli O157:H7 is dependent on cooking time and temperature. For example, if they cook to 155 degrees F, they should hold that temperature for 16 seconds. It is not realistic to expect that consumers, many of which are children will scientifically measure the internal temperature of hamburgers.

6. The way ground beef is packaged, it is virtually impossible to remove it from packages or chubs and make patties without spreading contamination if it is present.

7. Sometimes ground beef appears to be cooked when it really isn’t. There is a phenomenon called “premature browning” that can make ground beef appear to be fully cooked when in fact it is undercooked.

8. E. coli O157:H7 may be present in beef products other than ground beef. For example, in non-intact beef products, including tenderized steaks that are not always cooked to temperatures required for inactivation.

9. There have been many cases and outbreaks of E. coli O157:H7 associated with foods that are not cooked (i.e. fresh cut produce).

10. As Senator Patrick Leahy said after the 1993 Jack-in-the-Box outbreak – “The death penalty is too strong a punishment for undercooking a hamburger”.  He was right –consumers will make mistakes. There needs to be a margin of safety so that undercooking does not result in disease or death.