American authorities are attempting to bring their fundamental food law on product safety into the 21st century. They are not alone in doing this. Most developed countries are working with legislation that is decades old and regulations that have been amended so many times that no one can be quite certain of all they contain. This article offers a view of the Food Safety Modernization Act (FSMA) from those of us exporting into the U.S.

In Canada, we have a somewhat similar initiative underway with the recently introduced Safe Food for Canadians Act (SFCA), which is intended to update, streamline and combine four current statutes. In addition, according to the Canadian Food Inspection Agency, the SFCA “will be an important step in aligning Canada’s food safety system with our trading partners, such as with the Food Safety Modernization Act in the United States.” We shall, no doubt, see.

Challenges for All Food Regulators
There are many stimuli for all these efforts to improve food safety legislation, regulation and compliance, among which international trade is only one consideration. They have been growing in significance in the last 20–30 years and include the following:

Foodborne Pathogens. In addition to old acquaintances such as Salmonella and Clostridium perfringens, we now have Listeria monocytogenes, which has gone from a laboratory curiosity to a major public health concern. The year 1985 was a banner year for bad bugs in food in the U.S., with the largest yet recorded outbreak of salmonellosis (from milk) and the deadliest outbreak of food poisoning (from L. monocytogenes in soft cheese) since the U.S. Centers for Disease Control and Prevention (CDC) began keeping records. Since then, the incidence of outbreaks from most of the common bacteria, except Salmonella and Vibrio, has actually fallen, but still CDC estimates that each year roughly one in six Americans (or 48 million people) gets sick, 128,000 are hospitalized and 3,000 die of foodborne diseases. Somewhere someone, probably a young postgrad in microbiology, is looking at another laboratory curiosity that will become tomorrow’s major food poisoning agent. Will our authorities and industry be ready?

Demographics. Every other aspect of society has already experienced the population bulge, which is just beginning to enter senior citizenhood. Now it is the turn of all of us concerned with food safety to deal with this surge in the proportion of the population usually described as elderly or immunocompromised. We have said for years that they are more susceptible to foodborne illnesses, more likely to contract them and to have more severe symptoms. However, now (certainly in my case) the they is us, and there are many more to come. Are our systems ready to minimize potential problems and accommodate sick seniors when necessary?

Food Variety. Despite the best efforts of locavores, the food business in North America is global. We have access to just about any product from any source. It seems almost anyone these days with a computer and Internet connection can become a food importer; this poses enormous problems for regulators. In their attempts to deal with these renegades as cost effectively as possible, regulators sometimes treat everyone as guilty until proven innocent, causing yet more problems for legitimate operators. Effective control of importers and imports is a key part of FSMA as well as our SFCA.

New and Novel Products and Processes. Our regulators have procedures established to deal with these innovations. They may require premarket approval, notification or nothing at all, depending on the perceived safety-related concern. A key question is whether the regulatory agencies have sufficient capacity to deal with all the new ideas coming to fruition. No company with a new ingredient, formulation or processing method wants to spend years compiling data for governmental review and then more years waiting for that review to be completed. This concern only grows when coupled with the next issue.

Demographics Again. It is not only the general population that is aging, but the staff of regulatory agencies as well. As increasing numbers of the general population reach retirement age, so too do increasing numbers of agency staff. We face an imminent loss of a great wealth of experience and institutional knowledge that even time will only partially replace.

New Control Protocols. Principal among these is Hazard Analysis and Critical Control Points (HACCP), which is a proactive, predictive, preventive procedure to enable operators to preplan everything they need to do to produce safe food. A complete HACCP plan contains all that is needed, including steps to ensure it is properly carried out and that it is reviewed and updated regularly. The formal adoption of HACCP is regulatory acknowledgement of what has always been true: Food processors are responsible for the safety of what they produce. There were some hiccups in the 1980s and ‘90s with different countries trying different ways of implementing the program. Now everyone seems to have agreed on the approach endorsed by the Codex Alimentarius, which still leaves necessary flexibility for national-, company- and product-specific requirements. One remaining challenge is the full inclusion of HACCP in regulators’ routine activities.

Budget. Last, but not least, in this limited list of challenges facing regulatory authorities is the need imposed on them to control their budgets. Other items on the list suggest that more, rather than less, activity will be required. This item makes that impossible. Instead they must look at doing different things and doing them differently. This is a major challenge to which FSMA may be part of the solution.

Challenges for Exporters to the U.S.
Companies hoping to establish a long-term export business face a myriad of regulations and regulating agencies. There is Customs and Border Protection of the Department of Homeland Security (DHS), the U.S. Food and Drug Administration (FDA; with or without FSMA), Food Safety Inspection Service (FSIS) and Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture and possibly other acronymic spoonfuls of alphabet soup. This is probably similar to the companies’ home country except that the acronyms are new and the range of responsibility of each agency may be different.

In my former corporate life, I was fortunate to have expert help. I worked for the Canadian arm of a European company. We had a sister organization in the U.S. with skilled staff knowledgeable in the minutiae of local requirements. Other companies with established cross-border business have built up long-term relationships with brokers and customers who can advise on new and changed regulatory requirements.

There will always be fly-by-night operators whose primary interest is not regulatory compliance but enforcement avoidance. They will be unlikely to read this magazine or to understand it if they did. But they will continue to try to import the occasional container of misbranded and possibly misconstituted products and cause consternation among all the responsible players in the market. FSMA requires FDA to collaborate with DHS on measures to combat these illicit imports.

For those hoping to establish a successful and growing export business, there are rules to be followed and errors to be avoided. The errors may be classified broadly as those to do with paperwork and those that are product safety related. The latter are, again, of two broad types, systemic and random.

Paperwork errors, while not directly related to product safety, are a major cause of frustration for all involved and take away resources that should be applied to more serious concerns. Everyone involved in the paperwork preparation, submission, review and decision-making process is a bureaucrat, and all should operate according to similar rules.

Those preparing documents for submission need clear, concise requirements consistently applied. It should not matter where a shipment is presented for entry into the U.S.; proper evaluation should give the same result in Washington State as in New England and everywhere in between. This also imposes a requirement on U.S. agencies to communicate fully and promptly within and between themselves, so that all border access points are working to the same rules.

Those reviewing documents expect three things: that they are 1) complete, with all questions answered, t’s dotted and i’s crossed; 2) correct, so there is not, for example, a Toronto office telephone number given for the Winnipeg processing plant and, of course, it is the t’s that are crossed and the i’s dotted; 3) compliant, such that the information provided meets all the relevant regulations.

As a senior technical resource, I was sometimes referred to as Dr. No, usually while helping another new batch of junior marketing persons design labels that included all the mandatory elements while excluding the more creative, that is, false or misleading, copy. The strategy not only helped develop compliant labels but also built the understanding that “no” is the easiest word for a bureaucrat to say. Remove any justification for it, and that may speed the process to a favorable outcome.

One specific requirement of FSMA is that prior-notice submissions will be required to include, as an additional element, any country to which the food has been refused entry. “Any country” presumably includes the U.S., so that companies will no longer be able to go shopping for an easier crossing point after an initial refusal. This confirms the need for excellent communication on the U.S. side of the border to facilitate entry of satisfactory shipments and prevent unjustified refusals.

Now, proceeding with confidence that the paperwork is all in order, what then of possible product problems? Most major processors in most developed countries have implemented some form of HACCP. In some jurisdictions, it is mandatory for some products. For example, here in Canada, it is required in all federally registered meat, poultry and fish processing establishments.

Each country and commodity may have its own name for the program, but all are based on the Codex HACCP principles. Importantly, too, those programs include the context, the background that HACCP requires to be effective. Whether called prerequisite programs, as in Canada, or Good Hygiene Practices (GHPs), they establish the basic operating parameters for the plant as described in the Codex Alimentarius General Principles of Food Hygiene.

HACCP is intended to be focused specifically on safety-related hazards and their control. The same principles may be used, and may be useful, in controlling all other, nonsafety aspects of product quality. However, these other aspects should be documented separately from the HACCP program itself.

In many countries, market sectors for which HACCP is not mandated are, nonetheless, implementing the program and enjoying the benefits of having done so. This is a good development, especially for those companies wishing to export to the U.S. Under FSMA, importers will be specifically required to have a program to verify that the food products they are bringing into the U.S. are safe. In FDA’s own words, “Among other things, importers will need to verify that their suppliers are in compliance with appropriate risk-based preventive controls that provide the same level of public health protection as those required under FSMA.” (See sidebar “Cross-Border Shipping Goes Both Ways”)

This is a tremendous burden to place on importers who do not have in-house technical expertise to provide the required verification. Importers will, of course, turn to their suppliers for the necessary information that will, eventually, be supported by certification from accredited third-party auditors.

However, HACCP implementation is not a guarantee that safety-related problems will all be either prevented or caught and corrected. It is possible that a CCP may be missed, a control limit may be set incorrectly or one or more of the GHPs may be inadequately specified. Such systemic errors should be caught as part of the regular review of the program’s implementation, but what of product made and shipped before that regular review?

There will always be random implementation errors. Something overlooked in carrying out the GHPs, a critical check missed at just the wrong time, resulting in one batch, one lot, perhaps one day of suspect production. And just to compound the problem, the missed check itself might be missed in the final records review and the product released for shipment.

Challenges for FDA
According to the Codex General Principles of Food Hygiene, the roles of government include the adequate protection of consumers from illness or injury caused by food and the maintenance of confidence in internationally traded food.

Therefore, does, or will, FSMA help FDA fulfill these roles? The answer so far appears to be that it should indeed help. At best, it can do no more than that. Regulations and regulators do not make food safe, only those involved in its production, processing, distribution and preparation for consumption can do that. The North American food processing industry is well aware of its responsibilities to produce and deliver safe food. The foodservice sector is equally well aware of its similar responsibilities, and consumers have every opportunity to make themselves aware of their role in the safe-food chain.

One main thrust of FSMA is protection through prevention, which extends the reach of FDA into foreign processing plants to the point of having accredited third parties certify that plants and products comply with U.S. regulations before anything is shipped. FSMA specifically requires that FDA set up this accreditation program. A major concern for exporters is that other jurisdictions may follow FDA’s lead and try to set up similar programs. Then exporters with multiple markets will face multiple audits to verify compliance with multiple regulations. Better for us would be an intergovernmental agreement on basic food safety principles and practices. Isn’t that what Codex is supposed to be?

Fortunately, FSMA does require FDA to take into consideration existing international standards and accreditation schemes when developing model standards under the third-party audit program. The intent here is to avoid unnecessary duplication of efforts and costs. We trust that means avoiding duplication by industry as well as by FDA.

Once the criteria are established and third parties are actually accredited by FDA, then they can embark on the voluntary qualified importer program. Just as there are programs allowing low-risk frequent travelers to cross the border more easily and FAST lanes for prequalified truckers, so now there will be speedier access for shipments of low-risk foods from certified suppliers. It is certain that accuracy of paperwork will be key to participation but, undaunted, many Canadian exporters are clamoring to know: When?

What are regulators to do about industry-led efforts such as the Global Food Safety Initiative (GFSI)? In Canada, there is no formal method for the HACCP program in many food sectors to be granted official government approval or even recognition. However, if, for example, the International Cookie Alliance (ICA) develops its own HACCP scheme, it can apply to have the scheme benchmarked against the relevant GFSI guidance document. Let us assume that this effort succeeds. Then any cookie company wishing to export to the U.S. that passes its ICA certification should be acceptable to all American retailers who agree with the GFSI approach of “once certified, accepted everywhere.” But will this be acceptable to FDA under FSMA? Can an industry-led initiative ever be fully accepted by regulatory agencies without loss of credibility among their citizens?

The emphasis on prevention and introduction of certification audits is aimed at the potential systemic errors, at finding any faults in a processor’s program and its execution, and correcting them at the source. While it all may seem somewhat onerous to the conscientious processor, another set of eyes can often be helpful. The 1:10:100 rule applies: spend $1 to prevent a problem, $10 to catch it before shipping or $100 to deal with it after shipping. For exports, the third factor may be even higher as guilt by association can adversely affect other exporters in the same country.

Systemic errors may be hard to find but random errors are much harder. They are, by definition, unpredictable. Canadian exporters have noted an increase in FDA activities at border crossings, leading to delays in shipments and increased costs. The hold-and-test program is proving particularly difficult and costly.
Governmental food inspection offers more comfort than protection. “Yes,” the typical consumer might say, “I know my food is safe because the government inspects it”—a comforting thought perhaps but rather naive. Some Americans might say, as might some Canadians, “I know my food is safe because I shot it myself,” which says more about the accuracy of the shot than of the statement. Some not-so-good news is that for imports into the U.S. in fiscal 2011, FDA inspected only 2.3% of food items. The better news is that those inspections were supposedly targeted at countries of origin, companies and products with a higher level of food safety risk.

If selection for inspection is risk based, then the program might be useful. As the International Commission on Microbiological Specifications for Foods has noted (applicable to other contaminants), when foods have been processed to reduce microbiological levels significantly, or have very low prevalence for other reasons, testing may not be the most effective means to verify microbiological status. Trying to find a random error by testing a random sample is a frustrating exercise.

However, many Canadian exporters question whether risk is the determining factor in selecting shipments for inspection. Their experience is that lots for inspection seem to be identified randomly rather than by a realistic risk evaluation, leading to unnecessary delays in clearing shipments and potentially serious customer service difficulties.

Other sectors have succeeded in making the border all but invisible for component shipments and for delivery of finished products. We hope that FSMA and other border-related initiatives will allow the food sector to achieve similar efficiency.

Where to Go from Here?
All regulators must implement what their legislators give them. No matter how much of their good advice is incorporated into a draft bill, regulators know that their particular legislative black box has its own peculiarities and that what is passed may be rather different from the original.

FSMA means that FDA cannot simply carry on doing more and more of the same old business as usual. It will be a long process requiring much hard work, but the U.S. is not working alone. There are agencies similar to FDA in many other countries at different stages of the same process. They are facing all those same challenges, from the apparent need to do more to the budgetary constraints that make that impossible. Some of them are finding innovative ways to make improvements.

Our own SFCA includes something new for us. It will allow for the incorporation by reference, following full consultation with all interested parties, of standards, protocols and procedures from other jurisdictions and advisory bodies. Similar food safety wheels already exist; they don’t need to be reinvented.

FSMA requires FDA to take note of international activities—a more active approach will be more beneficial. This seems to be an opportunity for FDA to consult, cooperate and collaborate to work toward a better system to deliver safe food to everyone by doing different things and doing them differently.

Roger H. Gould, Ph.D., is a technical advisor to the Food Processors of Canada. He can be contacted at



Cross-Border Shipping Goes Both Ways

Borders are no longer barriers in either direction. Just as FDA is seeking assurance, before shipments leave, that products from Outlandia destined for the U.S. actually meet all pertinent American requirements, so the Outlandian Food Authority seeks similar assurance that product from the U.S. (or anywhere else) meets all Outlandish requirements before it is exported to them.

The Outlandians consider their Food Code to be as good as any of their international competitors’, indeed, at least the equivalent of the best of them. Therefore, from their point of view, they are being only reasonable in expecting a direct quid pro quo between their Food Authority and the U.S. FDA.

If, say, We-B-Audits Inc. receives FDA accreditation to perform certification audits of would-be exporters to the U.S., then maybe they could also receive Outlandish accreditation to perform the similar function in U.S. plants hoping to export to Outlandia.

If this scenario comes to pass (as well it might), the next logical step is that We-B-Audits Inc. and similar organizations, thoroughly vetted to the highest international standards, become accredited by FDA for domestic inspection/audit activities.

They then take over these responsibilities on behalf of FDA. This will help reduce the size of government and leave FDA to manage the accreditation process and monitor the certifying bodies in addition to their other food safety-related duties of administering regulations, reviewing submissions for new ingredients and processes, and looking out for new food safety hazards.

That would be different.