Doering

  • Posted: February 27th, 2012 - 7:04pm by Doug Powell

    The former big cheese at CFIA says the most significant food safety development in the last decade has occurred outside public law — the extraordinary growth in the role of private-sector traceability systems characterized by third-party audits.

    Ron Doering, a past 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 for Food in Canada that large processors and retailers are requiring their suppliers to undergo regular inspections by third-party auditors. Producers, ingredient suppliers and processors must no longer simply have their own quality systems and meet government regulations; now they have to sign onerous supplier warranty agreements and open up their businesses to multiple audits. But these systems and their audit schemes have gone through some significant growing pains that have served to seriously undermine their credibility.

    Doering says part of the problem seems to be confusion about the role of the auditor.

    David Rideout, Canadian food safety expert, SQF auditor and trainer, says,
    “Third-party auditors have to identify objective evidence of compliance or non-compliance and understand that they are not doing second-party audits. My job is not to provide guidance and advice to the company; if I do, my manager rejects my audit, as SQF auditors must draw a clear line between third-party (non-consultative) audits and providing advice to the company, which is the role of second-party audits.”

    The largest international effort to bring greater rigor and standardization to third-party audit systems is the Global Food Safety Initiative (GFSI), started 10 years ago, but only with improved training, more rigorous certification and systems that audit the auditors can third-party audits regain the public’s confidence.

    And, as food safety expert Doug Powell of Kansas State has said, “Third-party audits are only one performance indicator and need to be supplemented with microbial testing, second-party audits of suppliers, and the in-house capacity to meaningfully assess the results of audits and inspections.”

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  • Posted: December 23rd, 2011 - 4:45am by Doug Powell

    Cyclospora in California strawberries in 1996 was Guatemalan raspberries.

    Salmonella in tomatoes in 2008 was jalapeno peppers.

    E. coli O104 in Spanish cucumbers was organic sprout seeds from Egypt.

    Ron Doering, a past president of the Canadian Food Inspection Agency who practices food law in the Ottawa offices of Gowling Lafleur Henderson, LLP, writes in his monthly Food in Canada column that food safety regulators face “diabolical complexity when they carry out investigations characterized by deep factual and scientific uncertainty.”

    “In the later two cases, investigators were dealing with rare strains of pathogens, and traceability was complicated by the fact that the source was unpackaged vegetables — without barcodes or lot numbers — that were quickly consumed, often with other produce. Microbiological testing proved quite unhelpful so investigators had to rely primarily on epidemiology. Pressed for “results,” both cases had regula¬tors initially jumping to the wrong conclusions, destroying in their wake the livelihood of many innocent people and seriously undermining the credibility of government food safety regulators. Both cases prove the “Iron Law of Food Safety Outbreak Investigations”— after the fact academ¬ics and the media will criticize government regulators either for overreacting or under-reacting.

    “Perhaps government regulators have themselves to blame for the Iron Law because they continue to buy into the academic theory and language that they are engaged in risk management. They should be so lucky. The classical model of risk analysis falls far short in describing what reg¬ulators actually do and in providing much useful guidance on how they should do it. In both cases, regulators were not dealing with risk — a concept that surely involves at least some aspect of measuring probabilities — they were dealing with uncertainty and crisis management.

    “The language of risk disguises the degree of ambiguity inherent in large-scale food safety investigations. “Risk” creates the illusion of precision, of assessing hazards in quantitative terms, or measuring the probability of harm. Science-based quantitative expert risk assessments often disguise the underlying subjective framework of assump¬tions and understate the high degree of uncertainty. Food safety risk assessors do not do double blind laboratory studies over a long period; they generally just review the conclusions of other scientists.

    “In fact, in spite of their name, they typically do not even assess cases of risk, as calculations of probability are usually impossible to determine especially in the context of an urgent food safety crisis.

    “The most that “risk assessors” can do is assess situations of uncertainty and then engage in a complex iterative process with decision-makers to try to find ways to man¬age an immediate issue fraught with multiple perspec¬tives where the science, however uncertain, is important but rarely determinative.

    “Understanding what is going on is complicated too by everyone pretending the de¬cision is mostly science-based, unadulterated by policy considerations, and that they are managing the actual science-health risk, not the perception of risk.

    “We need to abandon the language of risk and recognize that most food safety investigations are about issue man¬agement. We need to develop a new theoretical model and language that would borrow heavily from the emerg¬ing literature on adaptive management: in the face of such uncertainty, making policy choices and implement¬ing regulatory decisions should be recognized as neces¬sarily experimental; decisions are made that expect the unexpected; policies and regulatory responses are adapted as lessons are learned.

    “The new model would also have to more fully recognize that while food safety must be paramount, trade-offs and weighing benefits are always a necessary part of the process. And this model would have to grapple with communicating this uncertainty to a generally scientifically illiterate consumer who simply expects retailers to only sell safe food and expects the regulatory system to guarantee it.”

    Doering has some valid points. I don’t care what model is used as long as there is fewer sick people. Epidemiology, like humans, is flawed. But it’s better than astrology.

    The more that public health folks can articulate when to go public and why, the more confidence in the system. Past risk communication research has demonstrated that if people have confidence in the decision-making process they will have more confidence in the decision. People may not agree about when to go public, but if the assumptions are laid on the table, and value judgments are acknowledged, then maybe the focus can be on fewer sick people.

    On June 12, 1996, Ontario, Canada's chief medical officer, Dr. Richard Schabas, issued a public health advisory on the presumed link between consumption of California strawberries and an outbreak of diarrheal illness among some 40 people in the Metro Toronto area. The announcement followed a similar statement from the Department of Health and Human Services in Houston, Texas, which was investigating a cluster of 18 cases of cyclospora illness among oil executives.

    Turns out it was Guatemalan raspberries, and no one was happy.

    Once epidemiology identifies a probable link between a food and some dangerous bug, health officials have to decide whether it makes sense to warn the public. In retrospect, the decision seems straightforward, but there are several possibilities that must be weighed at the time.

    Back in 1996, when the Ontario Ministry of Health decided to warn people that eating imported strawberries might be connected to cyclospora infection, two outcomes were possible: if it turned out that strawberries were implicated, the ministry made a smart decision, warning people against something that could hurt them; if strawberries were not implicated, then the ministry made a bad decision with the result that strawberry growers and sellers lost money and people stopped eating something that was good for them.

    If the ministry decided not to warn people, another two outcomes were possible: if strawberries were implicated, then the ministry made a bad decision and people could have acquired a parasitic infection they could have avoided had they been given the information (lawsuits usually follow); if strawberries were definitely not implicated then nothing happens, the industry does not suffer and the ministry does not get in trouble for not telling people.

    These scenarios apply to any decision to go public.

    It’s not that a new model is required – any model will do – as long as someone in some regulatory agency will put in writing the decisions involved in when to go public, with all assumptions laid bare. Then it can enter public discourse and be improved.

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  • Posted: October 15th, 2011 - 5:01am by Doug Powell

    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

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  • Posted: April 14th, 2011 - 6:20am by Doug Powell

    A bunch of Canadian medical types say Canada sucks at food safety; the first president of the Canadian Food Inspection Agency disagrees.

    They’re both wrong.

    "Canada's public and private sectors are not doing enough to prevent foodborne illnesses," writes Dr. Paul Hébert, Editor-in-Chief with coauthors. "Among the major failings are inadequate active surveillance systems, an inability to trace foods from "farm to fork" and a lack of incentives to keep food safe along the "farm to fork" pathway."

    Maybe. But citing self-published reports that haven’t been peer-reviewed doesn’t lend much credibility to the argument. And speaking on behalf of all Canadians, with statements like the following further disminish credibility.

    “Canadians are usually good at regulation. Canada’ s pragmatic yet stringent regulation of financial institutions ensured that the economic downturn has been less severe here than in other countries. In health, our blood system’s surveillance programs and ability to trace products from ‘vein to vein’ is another fine model.”

    The way Canada handled the emergence of HIV in the blood supply in the early 1980s was an international embarrassment. Good regulation does not equate to good enforcement. I don’t know what banking has to do with food safety other than it’s another myth Canadians like to comfort themselves with at night, content their world doesn’t contain the harsh nasties of other places.

    Oops, that’s a generalization. I should stay away from that; so should editors of journals.

    Ron Doering, an Ottawa lawyer and a former CFIA president, will give a speech on food safety at McGill University on Friday during the launch of the school’s new Chair in Food Safety, the first of its kind in Canada. Although he agrees the system could use some improvement, Mr. Doering said it is not in a ramshackle state.

    “I’m not aware of any system anywhere in the world that’s better than ours on public health reporting for foodborne illness,” he said. “It doesn’t mean it’s perfect. There’s no zero risk. But I’m not aware of any study that demonstrates in any persuasive way that any country has a better food inspection system than Canada.”

    Doering is right there is no published study that demonstrates one food safety system is better than another; such comprehensive studies are difficult, expensive and don’t mean much. But the listeria outbreak of 2008 in which 23 died was another international embarrassment, the Ontario salmonella-in-sprouts outbreak that sickened over 600 was another, and what is going on with E. coli O157:H7 in walnuts is another shameful addition.

    There are lots of great epidemiologists and public health professionals in the Canadian system – but they are stifled by a system that rewards mediocrity.

    The only way consumers will be able to exercise choice is to market food safety at retail, get beyond the platitudes, and show some data.
     

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