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.)


Regardless of regulation, actually employing best practices matters

A lot of folks in the food system are concerned about the potential for FDA’s Food Safety Modernization Act (FSMA), and associated rules, to negatively impact businesses. There’s been a bunch of rhetoric and uncertainty around the final rules and what will be needed to comply. The majority of the content of the proposed Produce and Preventive Controls Rules summarizes the industry’s best practices and lists the references behind decisions.tomato_dump_tank

Not much in there that’s a surprise for folks who have been paying attention.

The focus of FSMA is on identifying hazards, putting steps in place to manage them and actually doing it. The best businesses are already doing this.

There are some specifics like manure incorporation and what a qualified individual is (who is supposed to be responsible for written plans) that need to be worked out. But employing practices and putting systems in place based on the best available science goes a long way in the absence of a regulation.

Back in the day when we were working with produce farmers and packers in Ontario (that’s in Canada) that’s what we tried to do – to stay ahead of the market requirements and regulation.

It’s not a unique approach – the almond industry took a similar path, so did Florida tomato growers and leafy greens producers in California and Arizona to some extent.

According to Lancaster Online, Pennsylvania farmers, through ag educators might be focusing on the uncertainty.

Ag educator Jeff Stoltzfus said he has learned a lot about food safety in the past five years.

But when it comes to the U.S. Food and Drug Administration’s efforts to overhaul food safety regulations, he’s still trying to figure out the impact it will have on the growers he works with.

“What we don’t know is more than what we do know,” he told a group of growers gathered recently at Yoder’s Restaurant for New Holland Vegetable Day.

Keeping good records, he said, could be the most important thing for growers to protect themselves in case a problem arises.

“Records are going to be very important and policies will be even more important, especially if you’re taking stuff from other growers.”

I disagree – actually employing the correct risk-reduction practices based would top my list. The documentation is nice and shows a regulator or a buyer that you know what you’re talking about – but doing it is more important.

FSMA: Will new laws make fewer people barf? No

A little over a year ago, 6-year-old Owen Carrignan of Millbury developed a bad stomachache after returning home from a sleepover. The healthy first-grader was soon hospitalized with severe diarrhea and failing kidneys. He died less than a week later from a foodborne bacteria.

The Boston Globe reports that state health officials recently closed the investigation, unable to identify the culprit food that caused Owen and another Worcester county resident — an unidentified woman in her 30s — bureaucratto become seriously ill with the same strain of E. coli bacteria around the same time last year.

“We want answers, but there are no answers,” said Michelle Carrignan, Owen’s mother. “I have a hard time food shopping because I keep thinking there could be something here that killed my son.”

“We know that we won’t get to a zero-risk food supply,” said Michael Taylor, the FDA’s deputy commissioner for Foods and Veterinary Medicine. “But consumers have a right to expect that everything that can be done to prevent problems really will be done.”

The new procedures can’t come soon enough for Paul Schwarz, of Independence, Mo., who lost his 92-year-old father in 2011 to a listeria infection traced to a contaminated cantaloupe from Jensen Farms in Colorado.’

The new rules won’t address all food-safety concerns. The produce rules for overhauling the growing practices of farms to prevent contamination, for example, don’t apply to small establishments with less than $250,000 to$1 million in annual sales — the exact amount has yet to be determined.

The rules also exempt produce that is normally not consumed raw such as corn and potatoes, because the likelihood of microbes surviving the cooking or canning process is low.

Promise of food safety law largely unfulfilled

Waiting for government is like Waiting for Godot. Which is why the most important part of a USA Today feature on delays to implementation of the Food Safety Modernization Act is a throw-away at the end of the story. “While some businesses are waiting until the food safety rules are published, many companies are already incorporating their own food safety handling and transportation measures into their operations. The threat of potential litigation, long-term damage to their brand and a surge in the use of social media tools by the public to communicate has put more pressure on businesses to meet or exceed existing food safety requirements, said former FDA food czar David Acheson. “Hy-Vee, the 234-store, West Des Moines-based grocery chain has hired an outside auditor to do inspections of its stores. It also has worked with its distribution centers to make sure they handle and transport food using the same standards, such as ensuring sanitary conditions and uniform temperatures are maintained. “There is cost involved but it’s a cost of doing business and certainly it’s nothing compared to not doing it,” said Ruth Comer, assistant vice president of media relations with Hy-Vee. “If something isn’t done and there is a food borne illness outbreak or another situation that one incident could be far more costly than any protective measures.” Hy-Vee has only now just hired its own auditors, and is implementing standards across its supply chain? Maybe that’s why I never shop there.

About time: FDA halts company’s peanut butter operations

Once again, audits, inspections and the buyers at some of the biggest retail chains in the U.S. (and globally) have imperiled consumers by allowing shoddy product on the shelves.

According to AP, the U.S. Food and Drug Administration has halted operations of the country’s largest organic peanut butter processor, cracking down on salmonella poisoning for the first time with a new enforcement authority the agency gained in a 2011 food safety law.

But I keep getting told the Food Safety Modernization Act is about prevention?

FDA officials found salmonella all over Sunland Inc.’s New Mexico processing plant after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the plant and sold at Trader Joe’s. The suspension will prevent the company from distributing any food.

Sunland sold hundreds of products to many of the nation’s largest grocery chains.

Nothing will change until retailers get their collective heads out of ______ and start marketing microbial food safety so consumers have some semblance of choice.

FDA can’t afford new food-safety law; wants industry to pay

The U.S. Food and Drug Administration said it is having difficulty implementing expansive new rules to improve food safety, nearly two years after President Barack Obama signed them into law.

Reuters reports that FDA Commissioner Margaret Hamburg predicted yesterday that her agency “very soon” will issue new regulations needed to enforce the Food
Safety Modernization Act, a sweeping law enacted to upgrade the security of the U.S. food supply after a deadly salmonella outbreak in 2009.

Hamburg called on private industry to help finance the law’s provisions. The FDA regulates about 80 percent of the U.S. food supply. The Department of Agriculture oversees meat and poultry.

Will food safety rules really make fewer people barf?

There’s been a few stories of late asserting that the U.S. feds’ delay in passing some new food safety rules is somehow making food more dangerous.

Maybe for the talking heads in Beltway-land, but there is no evidence any rule would have made a cantaloupe farmer add sanitizer to his wash water and not kill 35 people.

The animal welfare types figured this out a long time ago: don’t even bother with government, go to retail and consumers’ pocketbooks. That change, even in the absence of evidence, happens much faster.

Producers, take responsibility for your own food safety. Do you really need a babysitter?

Still lots of people getting sick; CDC says most foodborne illness rates remain static

Only Washington-types could take a story about recent successes and failures in foodborne illness rates and surveillance – 18 fascinating papers — and turn it into a whine about how lobbyists were excluded from access, ahead of mere mortals.

The Washington Post reports that unlike last year, the U.S. Centers for Disease Control released the data without reaching out to consumer groups and other key stakeholders who typically are notified in advance. Instead, the charts and graphs were quietly posted online Friday.

I’m not sure who these key stakeholders are, and how many of them are self-proclaimed. The solution is for CDC to publish a press release summarizing the findings, note their existence, and releasing it to everyone at the same time.

And only in Washington would people whine that delayed passage of the Food Safety Modernization Act is leading to increases in foodborne illness.

“Everyone was hoping that this new food safety law would be in place and we’d start seeing improvements by now,” said Erik Olson, a director at the Pew Health Group. “What these CDC numbers show is that unless new protections are put into place, millions of Americans are going to continue to get sick from contaminated food.”

I’m immediately suspicious of people who speak on behalf of everyone (and people who say trust me). I have yet to see a credible, detailed analysis that shows FSMA will lower rates of foodborne illness.

But that’s the bizness of Washington. They don’t seem good at it.

Four years ago, the CDC numbers yielded the same story – rates were stagnant, but still way too many sick people. There is no evidence educational campaigns do anything except make people feel like they are doing something, there is no evidence legislation does much, yet that’s always the punchline: we need more laws, we need more education.

Doesn’t work.

We need new messages using new media to really create a culture that values microbiologically safe food.

That’s what I said four years ago, it could have been 20 years ago. Same as it ever was.
The most recent figures from the Centers for Disease Control and Prevention show that the rates of infections linked to four out of five key pathogens it tracks — salmonella, vibrio, campylobacter and listeria — remained relatively steady or increased from 2007 through 2011. The exception is a strain of E. coli, which has been tied to fewer illnesses in the same time frame.

The CDC found that the most frequent cause of infection in 2011 was salmonella, followed by campylobacter.

Below are actual excerpts from the CDC summary report. All 18 abstracts will appear on bites-l as soon as I complete a long plane ride, custom(s) probing, and return to the land of unlimited Internet.

Foodborne disease is an important public health problem in the United States, with an estimated 9.4 million domestically acquired illnesses and 1351 deaths from known pathogens each year. The Foodborne Diseases Active Surveillance Network (FoodNet) tracks important foodborne illnesses, generating information that provides a foundation for food safety policy and prevention efforts. FoodNet has provided information that contributes to food safety efforts by estimating numbers of foodborne illnesses, monitoring trends in incidence of specific foodborne illnesses over time, attributing illnesses to specific foods and settings, and disseminating information. Since it started in 1996, FoodNet has been an excellent example of partnership among federal and state agencies. This Clinical Infectious Diseases supplement contains a variety of articles that provide new information on current issues; together, they highlight FoodNet’s central role in U.S. surveillance and investigation of foodborne disease.

FoodNet’s core work is ongoing active, population-based surveillance for laboratory-confirmed infections caused by 9 pathogens transmitted commonly through food, as well as for hemolytic uremic syndrome. Several articles in this supplement report on these core data, examining trends and providing regulatory and public health agencies, industry, and consumer groups with data needed to prioritize and evaluate food safety interventions and monitor progress toward national health objectives. For example, Ong et al report the dramatic decline in Yersinia enterocolitica infections since 1996, particularly among young black children. Not all the news is good, however; Newton et al [analyze data from FoodNet and the Cholera and Other Vibrio Illness Surveillance System (COVIS), showing that Vibrio infections have increased nationally. Two articles in this supplement examine FoodNet surveillance data on invasive listeriosis. The article by Silk et al summarizes trends in surveillance data from 2004 to 2009, whereas Pouillot et al use FoodNet surveillance data to estimate the relative risk of listeriosis by age, pregnancy, and ethnicity, providing new insights into variations in risk across the population. Together, these articles emphasize that to substantially decrease the incidence of listeriosis, prevention measures should target higher-risk groups, particularly pregnant women, especially Hispanics, and older adults. Hall et al examine trends in Cyclospora infection, showing that outbreaks and international travel play an unusually large role in the epidemiology of these infections and suggesting that prevention efforts would most effectively focus on foods from and travel to endemic areas.

FoodNet continuously works to improve the quality of its surveillance data and methods for analysis. In this supplement, Henao et al describe the methods and rationale surrounding the introduction, in 2011, of a measure of overall change in the incidence of infection over time using surveillance data on infections caused by 6 bacterial pathogens. This measure, which provides a comprehensive picture of changes in incidence of foodborne infections, documents a 23% decline overall in incidence for these pathogens in 2010 compared with the first 3 years of surveillance (1996–1998). Although it does not replace pathogen-specific trend data, this summary measure can help inform the development and assessment of policies and interventions to prevent foodborne illness. Another article, by Manikonda et al, reports on a study to validate the reporting of deaths in FoodNet surveillance, an important issue because deaths, although rare, are disproportionately responsible for the economic and human costs of foodborne disease. Finally, Ong et al examine the impact of case ascertainment strategies and case definitions on surveillance for pediatric hemolytic uremic syndrome in FoodNet.

Several articles in the supplement elucidate aspects of the “surveillance steps” that are necessary for a case of infection to be ascertained by FoodNet surveillance. FoodNet and many other surveillance systems for bacterial enteric infections are based on culture-confirmed infections, so FoodNet surveillance data must be interpreted in the context of the “surveillance steps” that lead to culture confirmation: the ill person must seek medical care, a stool specimen must be submitted, and the clinical laboratory must test for and identify the pathogen. In particular, the recent and ongoing shift among clinical laboratories toward culture-independent methods for detecting enteric pathogens is of great importance.

In 2011, the CDC released new estimates of the number of foodborne illnesses in the United States, the Food Safety Modernization Act was signed into law, and new national health objectives for foodborne illness were set as part of the Healthy People 2020 goals. All of these initiatives, as well as continued concern about food safety on the part of the public and policy makers, emphasize the need for precise and accurate information about foodborne disease. Regulators and other public health officials, consumer advocates, industry, and others need information on trends, high-risk populations, and the foods causing illness so that interventions can be targeted most efficiently and effectively. FoodNet provides the articles in this supplement as part of its efforts to disseminate the results of its surveillance and analytic work. Although FoodNet surveillance is conducted in a geographic area that covers only 15% of the US population, the data it generates are a valuable resource for the entire United States. The FoodNet program shows the impact that high-quality, nationally coordinated surveillance can have on public health and policy.

The Food Safety Modernization Act: How not to make food safety law

It’s accepted wisdom among government workers who play hockey that Canada has an outstanding international reputation for designing regulations and is equally terrible at enforcement.

Ron Doering, a former president of the Canadian Food Inspection Agency who practices food law in the Ottawa offices of Gowling Lafleur Henderson LLP, writes in his monthly column that despite all the hype, the new U.S. Food Safety Modern¬ization Act (FSMA) signed into law by President Obama on Jan. 4, 2011, is a model of how not to make food safety law.

The Americans labored long and hard and delivered a mouse.

Under the FSMA, some powers of the Food and Drug Administration (FDA) are enhanced or clarified. For example, the FDA has powers to demand access to and copies of records when there is potential for serious health consequences (Canada has always had this). The FDA has also finally been given the power of mandatory recall after a Hearing (Canada has had this since 1997, without the right of a Hearing); and the FDA has the right to hold food products it has reason to believe are adulterated or misbranded (Canada has always had this).

But FMSA has two fundamental flaws, flaws so serious that the law may end up doing more harm than good. First, the Act provides a broad framework leaving to future regulations the real law. As everyone knows, the FDA is profoundly under-resourced to carry out its exist¬ing mandate — and the House Appropriations Committee recently recommended $285 million in cuts — and yet FMSA requires it to bring in more than 12 Rulemak¬ing regulations and more than 10 Guidance documents. The FDA has admitted it is already behind and that it may take many years before the regulations are enacted.

In the meantime, there will be real legal uncertainty for industry and consumers as the new law will be fully en¬forceable with little guidance on how it will be enforced.

The most serious flaw is the profound disconnect be¬tween the rhetoric about major improvements in food safety and the complete absence of new resources to walk the talk. For example, FDA is required to do 600 foreign facility audits next year and to double the number of audits every year for five years. The FDA has admitted this is completely impossible. As Peter Hutt, the dean of American food law lawyers, has recently observed: “The lack of reality in the statute is staggering.”

The import provisions of FSMA are the most relevant to Canadian exporters and, again, the law is confusing. Under section 301, every U.S. importer is required by January 2013 to carry out foreign supplier verification programs to provide assurances that the imported food meets the same level of public health protection as required of U.S. companies. Yet guidance on how this should be done will not be available on time.

In the meantime, effective immediately under section 303, the FDA has the power to require certification before the product can be imported. Certification can be provided by third-party auditors, but there are no guidelines on how this would be implemented or which entities would be acceptable third-party auditors. At the moment, the FDA is reluctant to accept private-sector audits done, for instance, under the Global Food Safety Initiative, even though they may be the best hope for improving food safety when there are more than 10 million importations of food every year into the U.S. under FDA jurisdiction carried out by over 150,000 importers.

There are lessons here for Canada. Don’t accept the facile argument that the state must move from reaction to prevention. The primary responsibility for food safety rests with industry — the role of the state is to make laws that it enforces, to audit industry’s risk management systems, and to be very good at reacting swiftly and fearlessly to protect the public when there’s a problem. Don’t mislead your citizens by telling them that you’re doing more than you are. And don’t legislate what you can’t enforce.

Ronald L. Doering, BA, LL.B, MA, LL.D, can be reached at: Ronald.doering@gowlings.com