Doering: Label raw milk cheese

Ronald L. Doering, BA, LL.B. MA, LL.D., a past president of the Canadian Food Inspection Agency and now counsel in the Ottawa offices of Gowling WLG, writes in his Food in Canada column that the science keeps piling up.

ron.doeringIt is not safe to consume raw milk and its products. The U.S. Food and Drug Administration (FDA) recently announced studies that show again that pathogens from raw milk including tuberculosis, diphtheria, typhoid, Salmonella, Listeria, and many other bacterial infections make it unsafe for human consumption. A comprehensive study was released last month by Belgian authorities that concluded that “raw milk poses a realistic health threat due to possible contamination with human pathogens.” Interestingly, the same study found that there was “no substantial change in the nutritional value of raw milk or other benefits associated with raw milk consumption,” but that’s a story for another day. And, of course, the unfortunate proof keeps coming, with hundreds of outbreaks, many deaths and thousands of illnesses just in the last few years due to raw milk and raw milk cheese.

Just because raw milk and raw milk cheese are not as safe as if they were pasteurized doesn’t necessarily mean that they should be banned. That is why regulations around the world are so inconsistent. The sale of raw milk is illegal in Scotland, but legal in England, Wales and Northern Ireland (indeed our future king will drink nothing else, a fact that could be used by both sides of the debate!). South of the border the states are roughly evenly divided, but interstate commerce is banned. Raw milk and most raw milk cheeses are banned in Australia but legal in New Zealand. In Canada, the sale of raw milk directly to consumers is prohibited by a variety of provincial provisions and it is a federal crime to sell unpasteurized milk under B.08.002.2(1) of the Food and Drug Regulations.

Canada continues to allow the sale of raw milk cheeses aged over 60 days, but provides this clear warning: “Health Canada’s ongoing advice to pregnant women, children, older adults and people with a weakened immune system is to avoid eating cheese made from raw milk as it does present a higher risk of foodborne illness than pasteurized milk cheeses. If consumers are unsure whether a cheese is made from pasteurized milk, they should check the label or ask the retailer.”

raw-milk-cheeseWhen I first wrote about this issue three years ago I pointed out the regulatory absurdity of the last sentence in the Health Canada (HC) warning. There is no requirement to label and most retailers have no idea if the cheese is made from raw milk, and have no means to determine if it is. At the time I received an informal response to my article from a senior official advising me that before moving to mandatory labelling, HC was going to partner with FDA to do a risk assessment of raw milk cheese, focusing specifically on the risk of illness from Listeria monocytogenes. The results of this risk assessment were released last summer: “The risk of listeriosis from the consumption of soft-ripened cheese made from raw milk is substantially larger than that for consumption of soft-ripened cheese made from pasteurized milk and the 60-day aging regulation actually increases the risk of listeriosis for consumption of raw milk cheeses.” The risk was found to be from 50 to 160 times greater. This resulted in HC issuing a Voluntary Guidance to manufacturers that included suggestions to industry to do regular testing of both the raw milk and the cheese and that “Manufacturers should consider labelling their products with the words ‘made from raw or unpasteurized milk’ on the front panel display and/or in the list of the ingredients.”

The Guidance document seeks feedback from stakeholders before developing new “policy and/or regulatory options.” Here’s mine, again: stop the bureaucratic dithering and do what the Americans, Brits and Europeans have already done – make it mandatory for all manufacturers to label their raw milk cheeses. It’s useless, as they say, to try to reason someone out of something they didn’t reason themselves into, so if we can’t stop people from consuming raw milk and its products, then let’s at least ensure that it is not consumed unknowingly particularly by children, the elderly or expectant mothers. HC now requires unpasteurized juice to be labelled. Who’s against mandatory labelling of raw milk cheese?

Separate science and politics? Think again. The case of folic acid fortification

Ronald L. Doering, the first and only president of the Canadian Food Inspection Agency anyone can remember, and current counsel in the Ottawa offices of Gowlings (, writes in his bi-monthly Food Law column that:

ron.doeringHere’s a true story I’ve used with my students to show that non-science considerations are always necessary and appropriate in science-based regulation. It illustrates how shallow and misleading is the current discussion about the need for greater separation between science and politics, an argument currently advanced by many academics and public sector scientists.

Once upon a time about 20 years ago when I was still a food regulator, a considerable body of research began to show that neural tube defects (NTDs) in newborns, such as spina bifida and anencephaly, could be significantly reduced if women took folic acid supplements in the months before and just after conception.

But this is before most women know they are pregnant, and in the U.S. more than half of pregnancies were unplanned. So regulators there decided to require the fortification of a common food and proposed to require the mandatory fortification of flour with folic acid.

Health Canada, concerned about the health hazard to the general population and citing the precautionary principle, wrote the U.S. Food and Drug Administration (FDA) urging it not to act until the science was clearer. Aware of the growing evidence of the effectiveness of folic acid, the FDA decided it could not wait for all the science, applied the precautionary principle and made fortification of flour mandatory (proving, once again, that the precautionary principle is never helpful as an aid to decision making but always useful to justify decisions arrived at for other reasons — but that’s a topic for another day).

This is where the story gets interesting.

Under Canadian law, once the American regulation came into effect, Canada would have to ban the importation of all products containing the fortified flour and we could no longer export flour products to the U.S. That’s a lot of food.

Under trade laws, Canada would have to have a science-based risk assessment to show that the fortification was unsafe.

amy_pregnantWe had no such science. Scientists conduct science-based risk assessments, then elected politicians and their senior advisors take the science and weigh it with economic, political, environmental, legal and ethical factors (this is not politicization of science; this is evidence-based policy making.) Appropriately applying non-science considerations, Health Canada rushed through a regulation matching the U.S. law, coming into effect the month before the American change. This continues to be our law today: see B.13.001, Food and Drug Regulations (FDR).

Now, 17 years later, 76 countries have followed Canada and the U.S. and require mandatory folic acid fortification of at least one major cereal, with nearly all fortifying at least wheat flour. Studies show a significant reduction in NTDs in those countries with fortification.

In Canada the reduction is estimated to be as much as 46 per cent.

But mandatory fortification is still a controversial public policy option.

Citing safety concerns, no European Union country has mandated fortification.

In New Zealand the issue is still hotly debated, with an interesting alliance between the Green Party and the Association of Bakers describing mandatory fortification as “mass medication” of the food supply, and insisting that the argument for fortification is not “science based.”

In the U.K., the Food Standards Agency has recommended fortification, but the debate continues: both sides insist that the position of the other is “not backed by science.” In Canada, the department that initially fought fortification now highlights that “the decline in rates of NTDs in Canada is a tremendous public health success story.” A major science journal recently described folic acid fortification as “one of the most successful public health initiatives in the past 50 to 75 years.”

What’s the moral of our story? Policy considerations enter into every stage of the process of science risk assessment.

You can’t take policy out of science yet much of our public discourse is still dominated by the quaint Utopian view that science and policy can, and should, be strictly separated. We urgently need to engender a broad debate about the role of science and scientists in policy making.

Important: Explaining Canadian food law and staying out of jail

Ronald L. Doering, a past president of the Canadian Food Inspection Agency and currently counsel in the Ottawa offices of Gowling ( writes:

Chance_go_to_jailFood company owners and managers are increasingly at risk of being taken to criminal court to face huge fines and imprisonment, even if they didn’t mean to do anything wrong, didn’t know they were doing anything wrong, or didn’t know that an employee was committing a prohibited act.

Everyone knows it’s a crime to sell unsafe food or mislabelled product, but there are many hundreds of other crimes in our food laws. Moreover, most of these offences are strict liability offences, which means that the Crown must only establish the criminal act; there is no need to prove that the accused intended or allowed the prohibited act to occur, even if the occurrence was totally accidental.

In Canada there is a defence to strict liability offences, a defence that deserves to be better known. In the leading case of R. v. Sault Ste. Marie, the Supreme Court of Canada recognized that in the case of strict liability offences “the accused can avoid liability by proving that he took all reasonable care; the defence will be available if the accused reasonably believed in a mistaken set of facts which, if true, would render the act or commission innocent, or if he took all reasonable steps to avoid the particular event.” Both branches of the defence turn on the notoriously vague concept of reasonableness.

There are several reported cases in environmental law and occupational

 health and safety law that help to define the scope of the defence, but there are very few that deal with food legisla­tion. Since 1992 it is settled law that the defence is available to charges under our Food and Drugs Act (FDA) but there are only three relevant cases to provide practical guidance to the industry. In HMTQ v. Stars Trading Co. (2003 BCSC 833) the company was selling imported coconut juice from Thailand to supermarkets in Canada without listing on the label that it contained sulphites, a potential allergen.

The accused argued the due diligence defence by claiming that it had received assurances from the exporter that the juice was sulphite free. The Canadian Food Inspection Agency (CFIA) had previously warned the company that it should test the product and the company had a history of non-compliance with the FDA. After a good review of the law, the Court held that the accused had not taken all reasonable care and therefore could not rely on the due diligence defence.

ron.doeringIn R. v. Can-na Foods-2 Ltd., Tran Quyen Luu, Jane Jay et al. (2003 ABQB 758) the accused meat manager Luu and the owner Jay were charged with selling horse meat as beef. The court held that all reasonable steps to determine the source of the meat had not been taken  and therefore the due diligence defence was not available. Heavy fines were imposed on the company, the employee and the owner.

In R. v. Ray’s Seafood Market the CFIA charged the accused with seven counts under the Fish Inspection Act of importing fish into Canada without an import licence. Both the trial judge and the Supreme Court judge accepted Ray’s due diligence defence, but the Quebec Court of Appeal quashed the acquittal and ordered a new trial, concluding that Ray’s excuse was es­sentially ignorance of the law, something that is never a defence.

The most significant new development in our law is the passage (though not yet proclaimed) of the Safe Food for Canadians Act. Under section 39 (1) the accused is liable on indictment to a fine of not more than $5 million or to imprisonment for a term of not more than two years or to both, but the person is not to be found guilty “if they establish that they exercised due diligence to prevent the commission of the offence.” The message for owners and senior managers is clear: a strong food safety culture passionately driven from the top down was always necessary to avoid recalls and protect the brand name. Exceeding standards and taking all preventative measures may also be the best way to stay out of jail.



Ron Doering: reducing antibiotics in meat

Ron Doering, the first and only president of the Canadian Food Inspection Agency anyone can remember, and current counsel in the Ottawa offices of Gowlings (, writes in his monthly Food Law column that:

Health Canada (HC) and the Canadian Animal Health In­stitute (CAHI), the trade asso­ciation representing Canadian veterinary drug manufacturers, are to be com­mended for their decision on April 10 to follow the American initiative to address the growing concern over antimicrobial resistance in humans by introducing measures to promote the more prudent use of antimicrobials in animal produc­tion. HC announced its intention (1) “to work towards the removal of growth promotion and/or production claims of medically important antimicrobial drugs” and (2) “to develop options to strengthen the veterinary oversight of antimicrobial use in food animals.”

ab.res.prudent.may.14Contrary to many mainstream media reports, this does not mean that Canada is phasing out antibiotic use in meat production. Moreover, both initiatives face several difficult barriers to implementa­tion. This month we look at the difficulties associated with the first proposal, leaving next month for an analysis of why the oversight role by veterinarians must be strengthened if we are ever going to make real progress on what may be the most serious public health problem of our time.

First some law. The licensing and sale of antimicrobials fall under the jurisdic­tion of the federal government and its Food and Drugs Act, but the authority to manage their “use” lies with the provinces. The provinces also have the exclusive authority over the practice of veterinary medicine. What this means is that HC can require that a vet drug no longer have “growth promotion” as an indicated use on its label, but under the current regime it has limited power to actually determine how the drugs are used.

The issue of preventing growth promotion claims, and whether such a step will actually make a real difference, is a complex one. To begin with, most antibiotics are not actually used directly for growth promotion purposes but rather for disease prevention and control, what is often called disease prophylaxis. Removal of growth promotion claims will not prevent drugs to claim and be used for disease prevention. Farmers can continue to give their animals low doses of antibiotics to keep them from getting sick. The Public Health Agency of Canada, estimating that 90 per cent of the medication on farms is used for disease prevention, argues that antimicro­bials should not be used in this way and should be “limited to treating infection and not long-term mass medication for growth promotion or guarding against disease.” Others argue that there is insuf­ficient science to support the conclusion that low doses given to animals contrib­ute to antimicrobial resistance in humans and that outlawing the practice would result in more animal disease and the need for more drugs for disease treat­ment, possibly exacerbating the problem of antimicrobial resistance. When the science is uncertain, policy development is always difficult.

What is clear is that the proposal will not even apply to a large amount of anti­biotic use because of regulatory loopholes that result in part from our jurisdiction­ally fragmented regulatory framework. Our provinces still allow veterinarians to prescribe drugs for purposes not indicated on the product label (extra-label use). Unapproved drugs may be used on ani­mals because it is still legal for drugs to be imported for livestock production “own use” (OUI) if the drug is not offered for resale and it is not a prescrip­tion drug. As well, Active Pharmaceutical Ingredients (APIs) can still be imported by livestock producers to be mixed into feed on farm. None of these unregulated antibiotics are covered by the proposal. The latest Canadian Medical Association Journal contains a critical assessment of Canada’s performance in enhancing antimicrobial stewardship in agriculture and veterinary medicine, but it does state that HC has recently proposed measures to address OUI and API so, hopefully, reforms may be imminent.

As we shall see next month, none of the barriers described above can be adequately tackled without Canada’s veterinarians and their provincial regula­tory bodies taking a greater leadership role in combating the serious and growing problem of antimicrobial resistance in humans. Nowhere is the concept of One Health more compelling.

Canadian food inspectors to report through Health, not Agriculture

The Canadian Food Inspection Agency, largely created and run for the first five years by my eventual friend, Ron Doering, is now going to report to Parliament via Health Canada.

My guess is that everyone got tired of the misguided rants about CFIA reporting through Agriculture, and that Agriculture was there to promote doug.ron.jan.13food, not protect public health, and it was an obvious conflict of interest.

Obvious only to conspiracy seekers.

Doering always had a straight answer – food safety has to come first, otherwise there is no market.

To me, the change is cosmetic, like promoters massaging language, so that genetic engineering becomes natural enhancement, or whatever the marketers are pushing these days.

I don’t care who does the regulating and inspection, as long as the results are available for public scrutiny.

Health Canada brags “this reorganization will strengthen Canada’s food safety system by bringing all three authorities responsible for food safety under one Minister. This will ensure clear focus, easy collaboration, and timely communication with Canadians when it comes to food safety. This change also further underscores the CFIA’s commitment to food safety as a top priority.”

According to Canadian Press, food safety in Canada is a three-way:

• Health Canada develops food safety standards and policies and participates in public awareness campaigns about safe food practices;

• CFIA checks that industry meets federal food safety and regulatory requirements; and,

• the public health agency steps in when outbreaks occur, gauging the scope of the problem, providing epidemiology services and advising people how to protect themselves.

Sounds great. Why has the Public Health Agency of Canada been silent for a week about the latest E. coli O157:H7 outbreak in hamburger?

Buy local but ignore locavore nonsense

My friend Ron Doering (left, exactly as shown) and I have exchanged barbs over the years but we can agree on the headline for his latest column: Buy local but ignore the locavores nonsense.

Doering, the first president of the Canadian Food Inspection Agency and the only one whose name I can remember now that the post is awarded to revolving civil servants – one of the last presidents did something with stamps or coins before food safety – practices food law in Ottawa (that’s in Canada) and shares his thoughts in a monthly column for Food in Canada.

Doering was gracious enough to share his regulator insights with my food safety risk analysis class when I was teaching in Guelph (also in Canada) and he touched on all the nuances that food safety critics or outsiders like me seem to miss.

Then we had beers.

Doering writes that buying local makes a good deal of sense when the natural conditions support the seasonal production of good, fresh local food. Who wouldn’t buy our local asparagus in June and fresh sweet corn and tomatoes in August? Canadians have always supported roadside stands of blueberries and local fruits and vegetables; we have always loved our local fish and local summer and autumn farmers’ markets.

What is new is the pretentious elevation of this simple idea by the chattering culinary class to the status of a comprehensive creed, which, they assert, can make a major contribution to a more sustainable food system. Locavores focus on the concept of the food mile to condemn the current system of globalized trade. They dream of a return to an earlier time when the food supply wasn’t controlled by big bad agribusiness.

It’s like hanging out with the mommies at the local park, the ones who would never talk to me except that I have a cute kid, a hipster bicycle trailer and a wedding band so I’m apparently not a threat, and they start telling me all their food pornography and preferences for junior. Am I really a bad parent because I refuse to buy organic?

Doering also writes that with their simplistic focus on food miles, locavores ignore other factors of sustainability. I was in a very chic restaurant in Tucson, Ariz. where the smug chef righteously proclaimed that all his ingredients were locally grown. He was quite offended when I asked him about the environmental and other costs of importing all that fresh water to grow that food in the Arizona desert. And how is it more sustainable to deny developing countries the opportunity to export their tropical fruits and vegetables?

Enjoy that coffee this morning from your backyard coffee tree.