Question authority: Science skepticism

Posted on December 18, 2019 by Douglas Powell

My friend Ronald Doering, the first president of the Canadian Food Inspection Agency, writes persuasively in this Food in Canada column last week:

In September, there were several media reports of a survey by 3M that found that 32 per cent of Canadians are “skeptical of science.” The results were universally treated as “worrisome,” “alarming” and “depressing” because such a lack of trust in scientists might skew policy discussions to non-science considerations (bad) and perhaps, as well, undermine funding for scientists (very bad).

As readers of this column over the years will know, I have a different view. While, of course, it depends on what you mean by “science,” generally my opinion is that everyone should be more skeptical of science. I’m not saying that science is not important. CFIA scientists and their 10 laboratories are critical to the work of the agency. We can never have too much good science.

What I am saying is that there are many reasons why ordinary citizens, and especially consumers, should always be skeptical of science:

Most science is a lot more uncertain than is usually acknowledged. In food and nutrition science, for example, you name the issue and I can give you conflicting science. Over the years in this column, I have demonstrated vastly conflicting science on, for example, genetically engineered foods, food irradiation, the safety of BPA in food packaging, the safety of farmed salmon, the safety of water fluoridation and food additives. We have seen that Canada’s top two scientists on the safe level of salt in our diets disagree so intensely that they routinely resort to vicious name-calling. Canada and the U.S. consider the science on folic acid so clear that they require mandatory fortification of certain foods, while every EU country interprets the science to be so dangerous that they refuse to fortify; both groups insist their policy is “science-based.” It is illegal to sell raw milk in Canada and Australia but legal in England, Wales and Northern Ireland; both sides insist their policies are “science-based.” Nutrition science vacillates wildly. With such pervasive uncertainty, isn’t it just common sense to be skeptical?

Consumers get their science information on food and nutrition from newspapers, magazines, television and social media, none of which have trained science reporters anymore and all of which trade in alarmist “investigations,” food company bashing, celebrity advice and 45-second clips. Most consumers cannot understand most food labels. Health claims are more about marketing than health. Scientific illiteracy and innumeracy abound. As Mark Twain observed, if you don’t read magazines and newspapers you are uninformed, and if you do, you are misinformed. (Of course, this column is an exception). In the face of such widespread misinformation, isn’t it just common sense to be skeptical?

One of the most pervasive myths is that science and policy can be separated. When I was president of Canada’s largest science-based regulator, I dealt regularly with scientists who were seemingly unaware of how much their science advice was imbued with unstated policy considerations. Policy implications enter into the risk assessment at virtually every stage of the process. Moreover, in our system, scientists don’t make policy. After the scientist does the science-based risk assessment, elected politicians and their senior advisors carry out the policy-based risk management responsibility by weighing the science with the economic, political, legal, environmental, and ethical considerations. This is not the politicization of science; this is evidence-based policymaking. These two separate functions are often conflated and the outcome presented as driven purely by science. Isn’t it just common sense to be skeptical of this “science?”

A scientist friend recently highlighted another reason to be skeptical. The university system still insists that professors publish or perish, which accounts for why so much published science is both unread and unreadable, contributing nothing of value to the public that pays for it. It is certainly common sense, he says, to be skeptical of this science. Given the growing recognition of the importance of diet for health and the growing threat of foodborne illness, we need more and better science to aid in policymaking. Having said that, the public should always be skeptical of the science that comes their way.

We’re both necessary evils, he gets paid better: Food lawyers

Posted on August 30, 2016 by Douglas Powell

Ronald L. Doering, a past president of the Canadian Food Inspection Agency and counsel in the Ottawa offices of Gowling WLG (Ronald.Doering@gowlings.com) writes in his latest Food in Canada column:

Except for maybe the Income Tax Act, it’s hard to imagine any area of the law that is more intimately pervasive in the daily lives of Canadians than food law. It regulates the agriculture and food industry, the second largest sector of the Canadian economy. For reasons of health, trade and consumer protection, this large and rapidly growing field has over a dozen specific federal statutes and many more provincial ones that form the basis of thousands of pages of regulations.

The food regulations under the Food and Drug Act are over 400 pages long and the nine sets of regulations under the Canada Agricultural Products Act are even much longer.

And yet, surprisingly, in this country, food law has not been widely recognized as a distinct area of law as it has been in the United States and Europe. We still don’t have a modern comprehensive text in food law. We don’t have a regular reporting service. Our law societies don’t recognize it as a separate area of specialization. Our law schools don’t teach it. Even lawyers who work for food companies don’t think of themselves as food lawyers. But this could all be changing.

One reason for the change is the dramatic growth in the scope and profile of food law over the last 20 years. While Canada got its first food adulteration statute as far back as 1876 and the original Food and Drug Act in 1920, to my mind, the modern era of food law can be traced to the famous 1993 “Jack in the Box” case that graphically showed the world that a young woman’s life could be ruined just by eating a hamburger that had an invisible trace of a little known bacteria. Several other high-profile foodborne illness outbreaks in the U.S. soon followed.

Twenty years ago this winter, Canada led the world when it brought together 16 programs that had formerly been delivered by four departments to integrate the whole food chain — seeds, feeds, fertilizers, plant health, animal health, all food commodities including fish — by creating the Canadian Food Inspection Agency (CFIA), a true watershed in Canadian food law. In the years that followed Canada too experienced many major national foodborne illness outbreaks causing many deaths and a flurry of new laws and regulations.

With the growth of food law in the last 20 years came the concomitant explosion of media attention to food issues sensationalizing a whole range of controversial food stories on, for example, pesticide residues, genetically modified foods, the danger of imported food, and mad cow disease. What the poor public mostly got was contradictory nutrition advice and bad science reporting. We saw the explosive growth of the urban foodie movement with its enthusiasm for local, organic and natural, whatever that means. Food stories rode the rising wave of social media. In 1993 a young journalist turned professor started what was probably the world’s first blog on food safety; now Doug Powell’s barfblog has 75,000 direct subscribers in more than 70 countries. When I started this column over 14 years ago many readers told me that it was the first time that they had ever seen the words “food” and “law” together.

Which brings me to what may be another interesting step on the road to recognition for this burgeoning area of practice and study. The Schulich School of Law at Dalhousie University has partnered with a nascent group called the Food Lawyers of Canada to host The Future of Food Law and Policy in Canada, Nov. 3 to 4, 2016 in Halifax with the stated purpose of promoting greater understanding and recognition of food law as a distinct discipline (visit foodlaw.ca/halifax2016).

Some years ago a food industry executive said to me: “Because food is so highly regulated, I guess you damn food lawyers are a necessary evil.” I took this as a compliment. We’ve been called worse.

Go to jail. Go directly to jail

Posted on October 20, 2015 by Douglas Powell

Ron Doering, counsel in the Ottawa offices of Gowlings, and a past president of the Canadian Food Inspection Agency, writes in his monthly Food in Canada column:

After warrants were issued for their arrest, the two food company executives turned themselves in to the police and then they were led into the court for their arraignment in shackles.

The Jensen brothers faced a possible six years in jail for the misdemeanor of failing to ensure the quality and safety of the food product they were selling. They did not go to jail primarily because they pled guilty. Last January they were sentenced to six months home detention and five years probation, and ordered to pay $150,000 in restitution.

The evidence was clear: neither of the corporate executives had any idea that their food product was adulterated or that they had done anything wrong. What’s going on here?

In this and several other recent cases, the United States Department of Justice has made it clear that it has adopted a new enforcement policy to aggressively use criminal prosecution against food company executives. Citing the serious public health consequences of foodborne illness, with 48 million Americans sickened every year and an estimated 3,000 deaths, Assistant Attorney General Stuart Delery has publicly warned corporate officers that they were now going to be held personally and criminally responsible if their companies failed to adequately control the quality of their food products. Delery has emphasized that introducing adulterated food into interstate commerce is a strict liability offence, meaning a company violates the law when it distributes an adulterated food whether or not it intended to do so.

In adopting this new aggressive policy the prosecutors have resurrected the old and mostly dormant 1975 U.S. Supreme Court decision in United States v Park, which held that corporate executives could be prosecuted criminally even for unintended violations of food laws by their companies. “This apparent revival of the Park Doctrine is a huge concern for the industry” asserts U.S. food law attorneys McGuireWoods.

This dramatic change in U.S. food law is evident in many recent cases. For example, in 2014 Iowa egg company executives pled guilty in a deal that included prison time and millions of dollars in fines after an outbreak that had sickened almost 2,000 people in 2010. In May 2015, arising from a tainted peanut butter recall in 2006, prosecutors extracted a settlement with the food giant ConAgra Foods that included a fine of $11.2 million, the highest criminal fine in U.S. food safety history.

This rising threat of criminal prosecution for food industry executives is real and has not gone unnoticed by food companies and their lawyers. Washington lawyer Gary Jay Kushner, a partner with Hogan Lovells and one of America’s leading food law lawyers, told me recently that “this is a serious development for food company executives. We’re seeing this increasing trend in a lot of cases.”

The most recent case that has garnered so much media attention involves the Peanut Corporation of America (PCA) in which an investigation revealed that its adulterated product had led to over 700 reported infections and at least nine deaths. After a six-week trial, a federal jury found PCA president Stewart Parnell and two other company executives guilty of violating several food safety laws and obstruction of justice. Because company employees falsified lab results and made several false and misleading statements to FDA investigators, prosecutors are seeking life sentences for PCA executives.

Criminal prosecution of company executives is not new in Canada. The Canadian Food Inspection Agency regularly brings charges in the criminal courts. What we haven’t seen yet in this country is major prosecutions of executives after recalls or prosecutors seeking jail terms for company executives who were unaware of any violation, though I know that this has been seriously considered in at least a couple of instances.

There is also another important distinction between Canada and the U.S. We have a longstanding, if narrowly defined, defence of due diligence in cases of strict liability offences; a defence that deserves to be better known, and the subject of next month’s column.

Regulatory myths

Posted on March 26, 2015 by Douglas Powell

Ronald L. Doering, the first president of the Canadian Food Inspection Agency and currently counsel in the Ottawa offices of Gowlings, writes:

One of the most persistent regulatory myths is the notion that politics can and should be kept out of science-based regulatory decision making. But as Covello and Merkhofer have clearly shown: “In practice, assumptions that have policy implications enter into risk assessment at virtually every stage of the process. The idea of a risk assessment that is free, or nearly free, of policy considerations is beyond the realm of possibility.” It is surprising how much our public discourse is still dominated by the quaint utopian view that science and policy can be strictly separated.

This enduring myth is the basis of the current kerfuffle regarding the government’s “war on science,” the allegation that decisions are based on ideology, not science, that politicizing science is a very bad thing and that all decisions must be “evidence-based.” Ironically, these same critics make a virtue out of being skeptical of mainstream science by opposing, for example, fluoridation, GM food, irradiation and vaccinations. But their basic misunderstanding is that they believe or pretend to believe that science and policy can be separated. Their whole concept of “evidence-based” is flawed. It is the legitimate and necessary role of politicians to take the science-based risk assessment and then carry out the policy based risk management function by weighing the social, political, economic, ethical and environmental factors in order to arrive at the appropriate regulatory decision. In our democratic system scientists cannot, should not, carry out what is the legitimate role of elected politicians and their senior advisers.

What should be the acceptable level of PCBs in farmed salmon? What should be the appropriate mix of rules to prevent the importation of BSE into Canada? What is the acceptable level of phthalates in plastic toys? What are the best regulations to prevent the importation of FMD into Canada? What is the right regulatory regime for the approval of genetically modified traits in seeds? What is the acceptable level of GM corn in wheat products? What should be the necessary rules for the storage of high level nuclear waste? What is the safe level of BPA in water bottles? How should the level of salt in processed food products be regulated? Should it continue to be illegal to sell raw milk? What should be the rules for raw milk cheese? This is just a small sample of the science-based public policy issues with which I was directly involved in recent years.

In all of these cases it was the regulator’s task to protect the public health and safety of Canadians through a complex process of weighing the many factors involved without, may I say again, the aid of some quantitative cost benefit analysis; the factors were too complex to be monetized in a way that would be useful for decision making. In all these cases the science was relevant by not determinative. And yet in all these cases the parties argued that the basic question was one of science: if only we could get the science right, the public policy answer would follow. If only the world were that simple.

When I was president of Canada’s largest science-based regulator, I dealt regularly with scientists who were seemingly unaware how much their science advice was imbued with unstated policy considerations, and how much the uncertainty of their science required the consideration of other factors. Many academic and government scientists and their public sector unions still shamelessly march in the streets arguing that decisions must only be “evidence-based.” My nutrition and food science students seem genuinely unaware, uncomfortable even, with the idea that science-based health risk assessments are replete with policy considerations.

We need to engender a broad public debate about the role of science and scientists in policy making. For starters we need to debunk the myth that politics can and should be taken out of science-based regulation making.

Recent research on third-party audits

Posted on September 3, 2014 by Douglas Powell

Ronald Doering, the first president of the Canadian Food Inspection Agency and the only one I can remember, writes in his Food Law column:

Until recently there has been little serious research on the most significant food safety advance in the last decade, a development that has been entirely outside the realm of public law — the extraordinary growth of third-party supplier audits. There are now over 500 food safety audit firms, many of which have global operations.

The Food Safety Service Providers, an industry association representing nine leading private food safety audit firms, asserts that its members alone conduct more than 200,000 audits and inspections in more than 100 countries each year. It has been estimated that in the U.S. the scale of private food law auditing activity is now 10 times larger than that of the federal government, more than all federal and state efforts combined. Two recently published academic studies provide interesting insights into several aspects of this important new area of food law.

Audits and Inspections Are Never Enough: A Critique to Enhance Food Safety (Food Control, vol. 30, issue 2) by Douglas Powell et al. identifies the many limitations of third-party audits and documents several cases of major foodborne illness outbreaks linked to food processors that have passed third-party audits. Audits need to be supplemented by other measures such as microbial testing, and companies must have in-house capacity to meaningfully assess the audit results. Third-party audits are part of “a shift in food safety governance away from government regulation and inspection towards the development of private food safety standards.” This study represents a cogent caution to the audit industry that they must improve their systems, and a warning to the food industry that audits are never enough.

In the latest Wisconsin Law Review American law professors Timothy D. Lytton and Lesley K. McAllister (Oversight in Private Food Safety Auditing: Addressing Auditor Conflict of Interest, 2014) provide the first comprehensive analysis of one of the most serious problems with private food safety auditing — auditor conflict of interest. Auditors are paid by the company being audited. Suppliers have an interest in finding the cheapest and least intrusive audit that will provide a certificate, and auditors have a financial incentive to reduce the cost and rigour of audits to get business in a very competitive environment. This study analyzes several oversight mechanisms that have been developed to mitigate the conflict problem, but concludes that at this time there are still too few financial incentives to assure more rigorous auditing.

Considering how few inspections are actually carried out by the Food and Drug Administration (FDA) relative to the number of businesses it is responsible for, it is ironic that the U.S. has been so reluctant to embrace more fully the advantages that third-party audits represent. Perhaps this is because President Obama is so beholden to consumer activist groups that do not trust the industry, believe that only FDA inspectors can stop big bad food companies from poisoning consumers, and who refuse to recognize that it is private audits that are increasingly the drivers of enhanced food safety. Obama has declared that it is the state that has the primary responsibility for food safety, and the former FDA commissioner dismissed audit schemes as being merely “a business strategy, not a public health strategy.”

In Canada we have always recognized that while it is a shared effort, practically and legally it is food producers that have the primary responsibility for food safety. Industry recognized some years ago that they couldn’t meet this responsibility adequately just by complying with government regulations — that they could protect their brand from recalls, minimize foodborne illness law suits, source ingredients widely and trade internationally only if, among other things, they insisted on warranty agreements from suppliers and that these were backed up by independent third-party audits. There are many legal and other problems with these relatively new instruments at this still early stage in their development, but they’ve come a long way in the last 10 years.

Finding ways to better integrate public law-based food safety regulations with private law-based certification systems may prove to be one of our more interesting challenges in the decade ahead.

Strengthening vet oversight of antimicrobial use in food animals: reducing antibiotics in meat — Part II

Posted on June 9, 2014 by Douglas Powell

Ron Doering, former president of the Canadian Food Inspection Agency and current counsel in the Ottawa offices of Gowlings (Ronald.doering@gowlings.com), reports with part II of his take on antimicrobiasl in food animal production:

While the medical community recognizes that the emergence and spread of antimicrobial resistance (AMR) in humans is a potential disaster for humanity and that it is the overuse of antimicrobials in human medicine that is the largest contributor, there is a broad consensus that the use of antibiotics in animals contributes to the problem, though the scale is still unclear. This uncertainty is due mainly to a failure to adequately control and monitor the use. Health Canada (HC) lacks the authority to control and monitor use because the practice of veterinary medicine falls under provincial jurisdiction. Recognizing that almost all practical efforts to reduce the level of antibiotics in meat depend on the more active participation of veterinarians, HC announced recently that it wanted “to develop options to strengthen the veterinary oversight of antimicrobial use in food animals.”

What can veterinarians and their provincial regulatory licensing bodies do now to reduce the threat of AMR? Here are four suggestions:

1. Enhance awareness among members .

While the Canadian Veterinary Medical Association (CVMA) has developed voluntary Prudent Use Guidelines, I’m told that many vets are hardly aware of the issue and may not even know of the Guidelines. Concerned enough about this, Ontario’s regulatory body, the College of Veterinarians of Ontario, just announced that it was launching a project to study the use of antibiotics among food animal veterinarians and to determine if they use the CVMA’s Guidelines in daily practice. Quebec requires a mandatory day-long AMR program and a test. All provinces should follow Quebec and develop mandatory continuing education programs on antimicrobial stewardship.

2. Fill the regulatory gaps.

As long as vets continue to prescribe off label use and the use of Active Pharmaceutical Ingredients (APIs) in production medicine, it’s impossible to know the level of antibiotic use. Own Use Importation (OUI) by animal owners is another avenue for which use information is unavailable. As one recent report stressed: “The gap in reliable usage data makes it difficult to state with confidence which antimicrobials are used, in what quantities, and for what purposes.” The recent critical assessment by a group of experts, titled “Stewardship of antimicrobial drugs in animals in Canada: How are we doing in 2013?” (Canadian Veterinary Journal, March 2014), highlighted the absolute importance of improving Canada’s monitoring of antimicrobial usage.

3. Conflict of interest issue.

This issue has been flagged by several reports going back to the landmark McEwen Report of 2002. Veterinarians obtain income from the profitable sale of antimicrobials. Decoupling veterinary prescribing from dispensing raises several issues because the current veterinary practice business model is based on an income stream from antimicrobial sales. Veterinarians should lead a dialogue on this important issue that clearly needs closer examination.

4. Antibiotics for disease prevention.

The real issue is not the use of antibiotics for growth promotion or the treating of disease, but whether they should continue to be used for disease prevention. While some antibiotics of very high importance to human health should only be used to treat infection, there are several arguments that some of high or medium importance to human health (what HC calls Category ll and lll, for example tetracyclines) should still, with closer veterinarian oversight, be used for disease prevention. Because major retailers, processors and consumers increasingly demand meat with “raised without antibiotic” claims, the marketplace is forcing changes in practice. But we mustn’t lose sight of the fact that while there are risks to using antimicrobials in animal production, there are also risks with non-use.

Two-thirds of animal diseases are zoonotic, meaning the disease is transferable to humans. For this and other reasons, I have been a long-time proponent of strengthening the connections between human and animal medicine — the concept known as One Health. In this context, AMR represents an historic opportunity for vets to step up and provide greater leadership.

Third-party audits are one component of food safety; just one

Posted on February 27, 2012 by Douglas 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.”

Uncertainty and outbreaks of foodborne illness

Posted on December 23, 2011 by Douglas 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.

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

Posted on October 15, 2011 by Douglas 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

Mediocrity wins Canadians lose with foodborne illness

Posted on April 14, 2011 by Douglas 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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safe food from farm to fork

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