Food Safety Counsel

The Food Safety Modernization Act for Dummies

Shawn Stevens — Sun, 12 May 2013 17:28:35 -0600

There has been a lot written in recent months about the perceived complexities of the Food Safety Modernization Act (FSMA).

The new requirements are broad and onerous, stakeholders complain. The proposed rules will be burdensome and costly, experts predict. And FDA enforcement will be varied and inconsistent, others warn. And, yes, even I have been at least partially guilty (I will reluctantly admit) of adding my own voice to the growing chorus detailing all the unfavorable features of FSMA.

But, as I continued to think about the problem, I quickly began to realize that none of this commentary is overly helpful for the business owner simply trying to achieve compliance. Most companies don’t really care about listening to experts pontificate endlessly (which has been going on months and, in some instances, years). Instead, most companies just want to be told what they need to do. So, with that in mind, I thought it would be helpful if we started with a blank canvas, and approached FSMA from a different angle. FSMA for Dummies – or, compliance made simple.
To start out, let’s be clear, the general principles underlying FSMA are really quite easy to grasp. In its most basic form, FSMA requires companies to make safe food.

Second, food companies shouldn’t be misled about the difficulty of compliance. How a company goes about making safe food is, well, with just a few exceptions, left up to the company itself.
So far, so good? I hope so. It’s not very difficult.

Next, to actually demonstrate to the FDA that a company has achieved compliance, a food company needs only to understand what the FDA inspectors will expect to see when they show up at the company’s door. Here too, the answer is very simple. Generally speaking, if you process food products using ingredients sourced from suppliers in the US, there will be just a handful of basic requirements.

Indeed, if you are a food company, and if you source your ingredients domestically, you will only be required to show: (1) that you have a written food safety plan; (2) that you have records to prove that you are following your written food safety plan; and (3) that you have a traceability system in place (or, stated differently, that you have records to demonstrate where your ingredients came from, the products in which your ingredients were used, and the customers to whom your resulting finished products were sold). In turn, the key to actually demonstrating compliance to the FDA (when the FDA visits your facility to perform its first FSMA inspection), is to craft your FSMA materials so that they are aligned as closely as possible with what the FDA will “expect” to see. Finally, if you process foods using ingredients sourced from overseas, you will also need to have a folder in your file cabinet (or on your computer) called “foreign supplier verification program.” More on that later.

As noted, the real cornerstone of FSMA is the development of a written food safety plan. To create your written plan, you will need to conduct a food safety assessment within your facility, identify those food safety hazards that are reasonably likely to occur within your products, and then develop and implement controls (i.e., critical control points) designed to manage those hazards.

It is important to note that the controls you identify will need to be proven effective (i.e., validation), and you will need to create and maintain monitoring records that will prove that your controls are working as intended (i.e., verification). You will also need to develop prerequisite programs designed to ensure that you are following good manufacturing practices, that your employees are following hygienic practices, and that your facility remains clean. Although you can actually write the first draft of your plan, it will ultimately need to be approved by a “qualified individual.” We, of course, can help you there.

To establish compliance under FSMA, companies will also need to adopt a robust traceability system. From a food safety standpoint, it will be very important in the eyes of FDA that all companies be able to identify the source of their incoming ingredients, the specific products in which those ingredients were used, and the companies to whom the resulting finished products were sent. This way, if there is a downstream problem associated with a product, the FDA can immediately trace the product back upstream, and then quickly identify, contain and then solve any potential problems.

So long as your program enables you to accurately and quickly accomplish these goals, the FDA will likely characterize your program as compliant.

Next, as noted above, if you do decide to source any food ingredients from foreign suppliers, you will also need to ensure that those suppliers are complying with each of the FSMA requirements as well. You can demonstrate compliance under FSMA by having a copy of your supplier’s written food safety plan (developed by a qualified individual) in your file. I would also recommend having your foreign suppliers audited annually, and to perform some type of microbiological testing to verify the effectiveness of their programs and the quality of the products they are shipping. Oh, and remember, both your plan and your supplier’s plan will need to be reassessed any time there is a change in any manufacturing process, or at least once annually, whichever comes first.

Finally, although this column attempts to capture the “essence” of what FSMA requires, I would not be doing my job as a lawyer if I didn’t at least offer the following disclaimer: there are at least a few finer rules contained within FSMA not specifically addressed in this column and, regardless of where they are hidden, all of the rules are and will be changing routinely. Thus, as you work to develop your plan, it will be critical to read the Act and ensure you understand each of the federal requirements and the FDA’s corresponding expectations. But, we, of course, can help with that too.

So, as you march forward toward compliance, rest assured, it really can be quite simple. Put simply: Yes, you CAN develop a written food safety plan and chew gum at the same time … just don’t do it on the production floor.

The Apples and Oranges of Occupational and Food Safety Culture

Shawn Stevens — Wed, 24 Apr 2013 17:19:56 -0600

I spend a lot of time thinking about food.

Although I defend food companies in high-profile foodborne illness outbreak lawsuits throughout the country, the majority of my time is spent working with clients to improve the quality of their operations from a risk exposure and brand protection standpoint. This is my favorite and most rewarding job -- working closely with food companies who, although not necessarily facing a large-scale outbreak or lawsuit, are nevertheless reaching out for advice on how to avoid both.

The easiest way for any food company to produce a safer product (and, by extension, to lower its risk), is to develop and adopt a robust food safety culture. But many companies struggle with the concept because it is too foreign, or they believe it will cost too much.

Many corporate leaders come from places other than the food industry, so they have little experience in food safety, and thus no corresponding desire to invest in the development of a food safety culture.

That’s why I started thinking about ways to address the food safety culture challenge from a different angle. As experts, we can’t just keep telling food companies they have to adopt a food safety culture, we have to help them do it.

So, how do apples and oranges play a role?

Well, we often characterize apples and oranges as being quite different. The reality, however, is that if we take a moment to think about it, the two fruits are really quite similar. They’re about the same cost, the same size, the same shape and the same weight. And, they’re usually placed in the same drawer in our refrigerator. To appreciate the significant parallels, we only need to open our eyes a little bit wider.

The same is true when it comes to the concepts of culture-driven workplace safety and food safety.

Most corporate leaders are intimately familiar with the concept of occupational safety. Notably, in virtually every workplace in America, the concept is driven home constantly. Everyone knows it, everyone gets it, and everyone accepts it.

And, most important, the language and messaging used to teach workplace safety is eerily similar (if not in most cases identical) to the language and messaging used to promote food safety culture. These parallels make the job of promoting a strong food safety culture in any organization exceedingly simple.

Indeed, companies can start down the road of developing a culture-based food safety program by taking all of their workplace safety placards, Powerpoints, videos and training materials used for occupational or workplace safety, and inserting the word “food safety” instead. Employees will understand it, management can teach it, and corporate leadership may even embrace it.

Although apples and oranges may look different, I would argue they sometimes fall from the same tree.

Brand Protection Requires More Than Wishful Thinking

Shawn Stevens — Wed, 03 Apr 2013 18:07:52 -0600

When it comes to the production of food, it is the things industry can’t see which industry fears most.

Lurking somewhere in the darkest corner of a hot box, in the silent throes of a sales cooler, or in a case-ready package being staged for delivery, there are a few colonies of pathogenic bacteria waiting patiently for their chance to wreak havoc in our business and lives.

For more than a decade, our firm has worked closely helping the meat industry with crisis management, regulatory response and complex litigation following large-scale outbreaks and recalls. The unfortunate reality from a business perspective is that, in a disturbing number of instances, when outbreaks and recalls occur, the companies that are involved cease to exist.

Watching innumerable outbreaks unfold over the years, our firm has gained a deep understanding about the science of food safety, the epidemiology of foodborne illness outbreaks and the legal consequences of food product recalls. We have also gained far-reaching experience analyzing why recalls occur in the first instance, and how they, in many instances, could have been avoided.

While all companies want their customers to believe that their products are as safe as possible, and try to communicate this fundamental message through their brand, in today’s world success requires more than just a good advertising campaign. In order so sell food safely, a company needs to demonstrate it can process a safe product. In order to process a safe product, the company needs to invest in making it a reality. Food safety, unfortunately, doesn’t just “happen” by itself.

Thus, when working to protect the interests of my own clients, I usually start with a Brand Protection Audit. Usually, I can accomplish what I need in just a single day. I like to interview employees to learn more about the company’s real food safety culture, and review food safety training materials to suggest improvements. I also like to assess a company’s written food safety plans, and look for hidden gaps that create additional exposure. Moreover, many companies are surprised to find out that their policies are not actually being executed as written.

In addition, companies can easily developing stronger and more effective supplier specifications, and indemnity agreements, that provide added protection, as well as ensuring that existing insurance coverage is sufficient to cover potential liabilities. We also work closely with companies to develop and then conduct mock recall training, in as close to a real-world scenario as possible, to test their ability to trace and also contain a potential problem.

Finally, we provide advice to our clients on to best respond to government-issued NRs (so as to avoid criticisms months or years later from a judge or jury), and also prepare for and respond to both routine and for cause Food Safety Assessments. Many companies simply do not realize that what they say today can (and always will) be used against them tomorrow.

With that said, merely creating the “image” that you care about food safety is no longer enough. History has taught us that by taking a few additional proactive steps right now, such as auditing the true depth and survivability of your brand (i.e., the Brand Protection Audit), companies can significantly and strengthen the trust in, and longevity of, their most important assets – their image and their brand.

Preventing Outbreaks And Recalls Is Becoming A Very "Hot" Topic

Shawn Stevens — Fri, 15 Mar 2013 17:51:05 -0600

Can anyone really guarantee that your products will never be implicated in a recall? For most raw beef processors, the response has consistently been that, in the absence of a validated intervention like high pressure processing or irradiation, such a statement was impossible.

Interestingly, however, processors may have more control than they think. Increasingly, the existence of positive regulatory findings on the one hand and outbreaks on the other are being linked objectively to identifiable events occurring in slaughter plants themselves.

Indeed, FSIS believes there is a direct correlation between hot days or high event periods (HEPs) in harvest facilities and E. coli O157:H7 findings. A high event period is a period during which the number of beef combos in a slaughter facility that test positive for E. coli O157:H7 is higher than expected, and thus may be a signal of a food safety failure and product cross-contamination.

As a result, FSIS has in recent guidance documents urged slaughter facilities to develop, implement and then closely follow a HEP program. In essence, these programs require slaughter facilities to take certain actions when their E. coli O157:H7 (or, non-O157:H7 STEC) findings exceed a certain threshold. Such actions can include retesting all negative product, or diverting all potentially affected trim to a renderer or validated cook facility.

Rather than just relying on FSIS to urge slaughter facilities to develop and follow HEP programs, processors should actually mandate that their suppliers adopt them. This way, if your supplier has an issue, you can ensure that his or her issue does not become your own. In turn, such requirements can and should be built wherever possible into your supplier specifications. Given what science has demonstrated, requiring your suppliers to respond appropriately to a HEP pursuant to established procedures will likely decrease your risk of being drawn into a recall substantially.

Finally, the analysis does not necessarily end there. Whenever a slaughter facility has an O157:H7 positive (whether operating under a HEP program or not), that facility should be urged to identify and divert any associated product. Put another way, if contamination exists in one lot, the flanking lots which test negative might be diverted as well. This is because, if E. coli exists in one lot, it may also be present at undetectable levels in adjoining lots as well.

So, what’s hot – and what’s not? Well, by casting a much wider net and diverting all potentially affected product in the event of a positive finding, the risk of any contamination leaving the facility undetected (and the chance of a future recall) can be reduced substantially as well.

Ensuring Compliance Under The FDA's New Proposed Food Safety Rules

Shawn Stevens — Thu, 28 Feb 2013 11:21:21 -0600

The Federal Food and Drug Administration (“FDA”) has now published its long-anticipated proposed rules on Preventive Controls for Human Food (written food safety plans) and Standards for Produce Safety.

According to the FDA, the two rules “are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (“FSMA”).”

The agency also claims that the new proposed rules “build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.”

FDA also expects to soon issue its proposed rule on importer foreign supplier verification. In the words of the agency, future proposed rules will address preventive controls for animal food, and also accreditation standards for third-party auditors.

In the paragraphs that follow, we take a few moments to break down the new rules into their most basic form.

Written Food Safety Plans (“HACCP”)

The most anticipated element of FSMA has been the requirement that all FDA regulated food companies develop and implement written food safety (or, HACCP) plans. The proposed rule on preventive controls for human food (i.e., requiring written food safety pans) would apply to all facilities that manufacture, process, pack or hold human food. In general, with only some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. With that said, it will be critical to consult with legal counsel regarding the applicability of the new rules, as certain exemptions and modified requirements have been established for some discreet segments of the industry.

In its most basic form, the new FDA rule requires that firms develop and implement written food safety plans to identify potential food safety hazards, put into place steps to address those hazards, verify that the steps are working, and outline how to correct any problems that arise. Under the new requirements, the written food safety plans should, at a minimum, include the following:

a hazard analysis;
risk based preventive controls;
monitoring procedures;
corrective actions;
verification procedures; and
record keeping.

In addition to creating plans that will pass the scrutiny of FDA, food companies will also need to demonstrate that these plans have been designed by a “qualified individual.” In this regard, please contact us for additional information on this requirement, as well as each of the discrete additional regulatory requirements food companies will need to satisfy in order to demonstrate full compliance with FDA. Click here to view a copy of the Proposed Preventative Controls Rule.

Future proposed rules will address importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.

New Produce Compliance Rules

In addition to publishing its proposed rules governing written food safety plans, FDA has also unveiled new rules governing produce production. The new FDA proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing designed and validated to eliminate or reduce known pathogens. The proposed rule focuses on various known areas of risk, and promulgates standards for the following:

agricultural water;
biological soil amendments;
health and hygiene;
domesticated and wild animals; and
equipment, tools and buildings.

The proposed produce rule is, according to the agency, the result of extensive outreach by FDA with consumers, government, industry, researchers, and many others. FDA has also stated that the produce rule is aimed at being flexible for different-sized farms, at complementing conservation laws and rules, and at not conflicting with laws and rules for organic farming.

With that said, it is important to note that certain farms would be exempt from most of the requirements if their sales average less than $500,000 per year during the last three years (adjusted for inflation), and if their sales to qualified end-users exceed their sales to others during the same period. Moreover, according to the rule, any farms whose average annual value of food sold during the previous three-year period is $25,000 or less would not be covered by the rule. Such farms would still be responsible for the safety of their produce, however, and the FDA maintains that the exceptions can be revoked under certain circumstances. In addition, states and foreign countries will be permitted to seek variances from provisions of the rule because of local growing conditions.

Although the rule is still in its draft form, the general compliance date is currently anticipated to be two years after the effective date of the rule . For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date. Additional time would be allowed for compliance with certain water requirements. Click here to view a copy of the Proposed Produce Rule.

Although FDA intends to publish various guidance materials to help industry meet the new requirements, the success of your business will ultimately depend upon your ability from a legal standpoint to demonstrate to FDA that you have achieved full compliance. In this regard, please feel free to contact our firm for additional insight and information regarding the new proposed rules, and how to best (and most efficiently and quickly) satisfy the new requirements.

Is it time yet for a single food safety agency?

Shawn Stevens — Sun, 10 Feb 2013 15:01:33 -0600

Our national food safety system traces its origins to the beginning of the 20th century, when there was virtually no oversight of our food production.

In response to a growing movement questioning the quality and safety of meat products, Congress enacted the Wholesome Meat Act in 1967, and the USDA hired and deployed federal inspectors to slaughter plants throughout the nation. The federal inspector’s job was to ensure through visual inspection that our food was being produced under sanitary conditions. Today, these inspectors remain in every federally inspected meat and poultry establishment in the country. While their mission has not changed significantly, the environment in which they accomplish it has.

Scientific and technological advances over the past century have revolutionized our understanding of pathogens and the causes of foodborne illness. Microbiologists, physicians, veterinarians, farmers, government regulators, and engineers have all worked together to develop the most effective food safety apparatus yet. The results have been largely responsible for a substantial decline in the number of foodborne illnesses in recent years.

In spite of the improvements, increased scrutiny has been placed on the food industry by the public, the media, and politicians, many of whom argue that even a single foodborne illness is entirely unacceptable and that more must be done regardless of the difficulties involved in detecting and preventing the presence of microscopic organisms.

The government answered these calls, in part, with the recent passage of the Food Safety Modernization Act. The act, which legislates the largest expansion of the FDA’s food safety authority since the 1930s, has been hailed as the most comprehensive piece of food safety legislation ever enacted. It seeks to radically transform the regulatory landscape for thousands of American and international food companies through the implementation of new requirements and a broad inspection apparatus ostensibly designed to ensure the safety of American food.

Unfortunately, the new legislation is, at least for now, effectively stalled. Many foresaw the difficulties in implementing the FDA’s wide-reaching reforms and, almost immediately upon passage of the law, began asking where the FDA would acquire the resources necessary to implement its dramatic reforms.

At a recent conference hosted by the International Association for Food Protection in Providence, R.I., participants were told by an FDA spokesperson that many of the FSMA regulations had not yet been finalized. In addition to budgetary shortfalls, substantial trade difficulties are rumored to have arisen over requirements placed on foreign establishments. He further explained that, despite the lack of progress, everything under the new FSMA remains in a “deliberative phase.” What that means remains to be seen.

What is clear is that concerns over another international economic collapse, spiraling national debt (which has already resulted in, among other things, the U.S. losing its AAA credit-rating), and the realization that government spending must be reined in immediately have resulted in what amounts to the possible economic infeasibility of the FSMA in its current form.

Critics have long argued that the government’s tendency to throw money, rather than solutions, at difficult problems would result only in a bureaucratic colossus. That now seems to be the case. The Government Accountability Office, for instance, recently identified as many as 15 separate federal agencies collectively administering at least 30 laws related to food safety.

Consider that in the U.S. Senate, the committees on agriculture; nutrition; forestry; homeland security and governmental affairs; and health, education, labor, and pensions are all actively involved in making decisions relating to food safety. In the U.S. House of Representatives, the committees responsible for making decisions include agriculture; energy and commerce; oversight and government reform; and science. Agriculture subcommittees of the House and Senate Appropriations Committees also play oversight and funding roles in how the major agencies carry out food safety policies. The potential for waste and redundancy under such a system is obvious.

In 2011, the FSIS received more than a billion dollars in appropriated funds, plus another approximately $150 million in industry-paid user fees. Yet, these two organizations have jurisdiction over only 10% to 20% of the U.S. food supply. FSIS employs a staff of more than 9,000 workers, approximately 8,000 of whom work in the roughly 6,300 meat slaughter and/or processing plants nationwide.

Processing inspection does not require inspectors to remain on the production line constantly or to inspect every single food product. Rather, inspectors are tasked with the responsibility of verifying a plant’s adherence to its HACCP program, examining its standards for sanitary conditions, ingredient levels, and packaging, and conducting occasional microbiological sampling.

Perhaps, the time has come to change the way we think about food safety. And, perhaps, nothing less than a complete overhaul of our national food safety apparatus would allow us to take the next big step forward.

How It Would Work

We have arrived at a fork in the road to safer food and are faced with the choice of continuing on the path we’ve taken—adding more rules, regulations, and oversight with the hope that we will reach a point at which foodborne illness disappears—or going in a different direction. The law of diminishing returns tells us that that in all productive processes, adding more of one factor of production (regulations and inspectors) while holding all others constant will at some point yield lower per-unit returns.

Thus, the real solution to this problem will most likely be achieved scientifically, not bureaucratically. Continuing to spend enormous sums of money on redundant, antiquated, and ineffective solutions is irresponsible and self-indulgent. Inspectors and laws are incapable of seeing microscopic pathogens. Government will still play a critical role in the design and implementation of an overhauled food safety system. But, it may be time to come to terms with the reality that pragmatism and science, rather than bureaucrats and legislation, make food safer.

The first step in setting an overhaul into motion should be the formation of an independent panel that is tasked with a top-down review of government food safety expenditures that focuses on waste and redundancy. Simultaneous studies aimed at identifying and developing a more streamlined inspection apparatus should be commissioned by experts in the field of science, technology, agriculture, and engineering.

Technology is increasing at a rate never before seen. Government should, for the first time in history, set the table for new discoveries in anticipation of the continued occurrence of existing and emerging pathogens. There are enormous changes on the horizon as a result of globalization, possible climate change, and financial challenges across the world. The results of these changes will lead to a far more dynamic environment surrounding the food industry. If we do not substantially modify our food safety systems, it is likely that neither the food industry nor government will be able to effectively address new and emerging issues relating to food safety.

In turn, many of the problems we face are likely better addressed by privatizing parts of the U.S. food inspection system. American companies have long partnered with industry through auditing, consulting, and inventing to bring cutting-edge technology into food processing environments.

Moreover, we are seeing a dramatic increase in the amount of imported food we consume. This trend is expected to continue into the foreseeable future. The lack of jurisdiction held by the FDA and USDA outside of the U.S. poses a unique problem that could be solved quickly if the government allowed U.S. companies to conduct inspection and verification activities on its behalf.

The inspectors themselves would have to be drawn from those currently working for the USDA and FSIS, providing what would essentially be a lateral transfer from the public sector to the private. Companies interested in doing the inspections would bid on the jobs, thus providing the best cost-effectiveness ratio possible while simultaneously promoting private sector research.

The infrastructure is already in place to begin implementing privatized inspection. The FSMA, which is currently stalled partly because of its massive size, provides a perfect place for government to begin transitioning inspection responsibility to the private sector. This solution would address the food safety concerns that the FSMA hoped to solve, while at the same time allowing private sector creativity and ingenuity to generate the most cost-effective means of implementing the law. As it stands today, the law is untenable. Privatization provides a means to enact the legislation and save money doing it.

The emergence of new technologies allows for faster, better communication, more effective microbiology, and improved food safety. Indeed, the calls for increased inspection are rapidly outpacing the capacity of government to implement them. Privatizing inspection with governmental oversight makes sense. It is likely that the necessity for in-line human inspection will soon be obsolete as advances in affordable robotics, information technology, and optics begin to outpace human capability.

We have seen more technological advances in the past 100 years than in the previous 50,000. All indications are that this exponentially increasing rate of growth will continue for the next century and beyond. This technological explosion, if continued at current rate, suggests that the changes in the next 20 years will exceed the collective advances of the entire 20th century. The prospect of such immense change is difficult for most people to grasp, but empirical data are difficult to dispute. If it is even close to accurate, the vast advances currently on the horizon in information technology, medicine, robotics, and nanotechnology could result in an end to disease, foodborne illness, and perhaps even world hunger.

It is incumbent upon us to maximize the implementation of technologies that can prevent illness, yield more food, and preserve resources. Allowing government to continue to bloat and expand while providing diminishing returns is inefficient, ineffective, and counterproductive. Technological, scientific, agricultural, and socio-economic changes have reached a confluence where great changes are not only possible but also necessary. Now is the time to act if we truly want to modernize American food safety.

Incentivizing Food Safety [PART II]

Shawn Stevens — Mon, 14 Jan 2013 14:55:39 -0600

In our last column, we introduced the fundamental challenges facing industry as it works to improve food safety. Some of the greatest challenges, when it comes to food safety, are driven by basic economics. This is because improving food safety, in most cases, costs money.

Unless everyone in the industry is investing in the same food safety systems, those companies that spend more money will (at least in the short term) face a substantial competitive disadvantage when compared to those companies that do not. Moreover, companies that aggressively search for and then find pathogens will, in most cases, face more governmental scrutiny than those that do not.

So, what can we do about it? As I mentioned last month, industry really needs additional help from an economic and regulatory standpoint.

FSIS can start by reconsidering its new, soon to-be-announced rules that, reportedly, will require ALL processing companies, without exception, to place validated cooking instructions (designed to address harmful pathogens) on mechanically tenderized steaks. Unfortunately, if enacted as proposed, the new rules would actually create a disincentive for food safety.

Indeed, not all processors are created equal. Requiring ALL processors to carry the same validated cooking instructions (thus passing their own exposure to end-users downstream) could create significant disincentives for more companies to invest in new interventions designed to actually eliminate pathogens. In my view, the solution lies in crafting the new rules so that processors will be EXEMPTED from the labeling requirements if they employ a validated intervention designed to address the risk. If this could be accomplished, the large restaurant chains (the real drivers in the market) would invariably move toward and embrace products that: (1) are subjected to those interventions; and (2) as a result, exempted from the new cooking labels and requirements.

Government should also consider tax incentives for testing and finding pathogens in food. Indeed, testing for (and then finding) pathogens can be very expensive. This is because establishments that test raw products are required to divert positive product to cooking or rendering. Common sense tells us that the harder companies test, the more pathogens they will find, the more product they will divert and the more revenue they will lose. Thus, of course, creates a significant disincentive to test and find.

So, is there a better way? I think so. For starters, I would counsel FSIS to reward (not punish) companies that aggressively test to find pathogens in their products. Next, I would urge legislators to expand existing tax incentives (there are already some) for testing, research and quality control.

Finally, I would lobby for the creation of meaningful tax credits which would extend to any products affected by contamination and then diverted from their original intended use.

These, of course, represent just a few ideas to chew on. In the end, we all know what we need to do – the problem is that we just need a few, extra incentives to get there.

Incentivizing Food Safety [PART I]

Shawn Stevens — Fri, 28 Dec 2012 14:47:34 -0600

Not a single day goes by when we don’t hear about the critical importance of food safety. We need to develop, embrace and encourage a robust food safety culture, we’re told. We have to tirelessly reassess and verify the effectiveness of our food safety programs, we’re led to believe. We have to invest in, and then build into our facilities, the best leading-edge interventions. And, we have to implement and invest in an increasing level of environmental and food product sampling and testing, its suggested.

That all sounds really great, but the reality is that we face substantial underlying fundamental problems when it comes to improving food safety. Each of the items I describe above cost money. Some of them, like new infrastructure to support new interventions, cost a lot of money. And, what happens when our competitors are not investing in these initiatives. Well, our competitors can sell a lot more product for a lot less money, and they will have a substantial economic advantage. And, a disincentive for food safety.

Set economics aside. What happens if companies who are aggressively testing finished products for pathogens actually find them (and, trust me, they will). Well, in most instances, a positive finding in a finished product will trigger a protracted and uncomfortable governmental response requiring proof of containment (when, in some instances, it’s nearly impossible to convince the government of anything). These companies will also in many instances be subjected to undeserved, drawn-out scrutiny of their operating programs.

The end result is that, while company A (which tests for pathogens) struggles for days or weeks to survive USDA’s criticism and scrutiny after finding them, Company B (which does not test for pathogens) will keep shipping contaminated product under the watchful eye of USDA. Why test, these companies might ask, when testing only creates more regulatory problems? So, we see yet another significant disincentive.

So, where is the incentive for competitors to invest more deeply in food safety? Well, we should all be doing what we reasonably can because it’s the right thing to do. But, we also need some help from an economic and regulatory standpoint. USDA needs to encourage the development and use of new technologies and testing programs, and then aggressively reward those companies that use them.

In next month’s column, I will detail some ideas that can help reverse this paradigm. And, while you may have to wait until then to hear what it is I have to say, I hope I’ve created at least some incentive for you to return – for the sake of food safety.

The True Benefits of Consumer Confidence in Food Safety

Shawn Stevens — Mon, 19 Nov 2012 08:45:20 -0600

FDA’s Deputy Commissioner for Foods, Michael Taylor, recently addressed the issue of the consumer confidence in food safety at China’s International Food Safety and Quality Conference last week. Taylor described the issue as “an important goal in its own right.” He stressed the issue is just as important as public health in regards to food safety. Taylor argued that we all benefit if we do not have worry about food safety. In turn, although Taylor pointed out that most consumers know that food is not 100% risk-free, he did explain that they expect a certain “basic level” of safety.

During the conference, Taylor also described the economic impact that consumer confidence can have on the industry as a whole. He stated, “it provides the foundation for the growing global trade, as well as robust domestic markets that are open to innovative products and technologies.” In contrast, he explained what happens when consumer confidence is lost. If a company’s product results in an illness outbreak, the company pays the price: they lose consumer confidence and profit. Often times, assuming the company survives, it can take a significant amount of time to rebuild consumer confidence.

Taylor also discussed how countries are revamping their food safety programs to help enhance consumer confidence abroad. Examples of these countries include: Canada, the Dominican Republic, and Vietnam. Taylor explained how the role of government is vital in aiding these new food safety initiatives. They can, in the end, and if done right, provide very “credible and effective” oversight.

Ultimately, Taylor stressed how it is the industry’s commitment and responsibility to food safety that will ultimately affect consumer confidence. As we always say, if industry continues lean forward in the food safety foxhole (as opposed to looking for ways to hide in it), both industry and the consumer will be better off.

New Food Safety Authority in Africa

Shawn Stevens — Fri, 02 Nov 2012 15:17:56 -0600

This past week, a team of international food safety experts met to set framework for a food safety authority in Africa. The meeting was hosted by the Interafrican Bureau for Animal Resources in Rwanda. The focus was on how to carry-out the African Union Commission’s (AUC) plan for a pan-African food safety program. The AUC would like to model their program after the European Food Safety Authority.

The center of the program will be on safety standards and to monitor food supply in Africa. During the meeting, they addressed need for such program, the objectives, structure/functionality, as well priorities and an implementation road map. There was also discussion of creating a Rapid Alert System for Food and Feed (RASFF) program in correlation with the authority. Notably, the European Union implemented a similar program back in 2002. This RASFF would act as a forum to share information about companies who produce products that might be of risk to consumers.

With the new program, AUC is hoping to increase standardization throughout the region which will, in turn, increase trade. Although the new authority is still in the planning stages, it looks like the initiative will continue to gain traction.

New National Food Policy Scorecard

Shawn Stevens — Thu, 25 Oct 2012 14:01:42 -0600

A new scorecard for lawmakers was launched on Wednesday by the advocacy group, Food Policy Action. The National Food Policy Scorecard will grade lawmakers on food issues relating to food safety, hunger, farm subsidies, farm workers’ rights and humane animal treatment. Other heavy-hitters in the food industry are backing the movement, such as Top Chef Tom Colicchio, Stonyfield Farm’s Gary Hirshberg, and Robin Schepper, the former executive director for Michelle Obama’s “Let’s Move” campaign.

The scorecard looked at over 30 key food policy votes in Congress. Lawmakers were rewarded for voting on initiatives to reduce or eliminate federal subsidies paid to farmers, boost E. coli prevention funding, and that repeal ethanol subsidies. However, they were penalized for voting to reduce food assistance or weaken pesticide regulations.

Food Policy Action feels that despite Democrats out-scoring Republicans, the food scorecard is objective and non-partisan. Scott Faber, VP of Environmental Working Group said, “Food is a bipartisan issue.” Adding that, “some Republicans scored well and Democrats scored poorly.” Others chimed in saying “it isn’t about politics, it’s about values.”

Food Policy Action’s mission is to increase awareness about food policy. More specifically, they want to promote policies that encourage “healthy diets, reduce hunger at home and abroad, improve food access & affordability, uphold the rights and dignity of food and farm workers, increase transparency, improve public health, reduce the risk of foodborne illness, support local and regional food systems, treat farm animals humanely and reduce the environmental impact of farming and food production.”

It is not set on how the scorecard will be implemented. Only a few media outlets have reported the results from the scorecard released this past Wednesday.

National Food Day 2012

Shawn Stevens — Fri, 19 Oct 2012 14:53:35 -0600

After the success of last year’s first Food Day, this coming October 24, 2012 will mark the second annual National Food Day. It is organized by the Center for Science in the Public Interest (CSPI), along with other leaders in the food industry, activists, and others from all across the country. The ultimate goal is to unify the nation’s key stakeholders to promote improved food policies. The campaign also addresses additional issues including: health and nutrition, hunger, agricultural policy, animal welfare, and farmer work justice (just to name a few).

Promoters of the initiative believe that food should bolster one’s health, not hinder it. Thus, a primary goal is to promote healthier, more affordable, and more sustainable food. In turn, there are many “Food Day” events occurring on October 24, 2012 throughout the country. To find out what events are happening near you, you can go to the Food Day website: http://www.foodday.org/all_events.

England Warns About The Use Of Liquid Nitrogen In Cocktails

Shawn Stevens — Thu, 11 Oct 2012 07:08:57 -0600

England’s Food Standards Agency (FSA) released an official warning in response to the increased use by many commercial establishments of liquid nitrogen in cocktail drinks.

The warning was issued after a young woman celebrating her 18th birthday consumed a drink containing liquid nitrogen and became very ill. She had complained of trouble breathing and stomach pains. Doctors found that her stomach had been perforated and performed immediate surgery. The young woman is now recovering, after having most of her stomach removed.

Liquid nitrogen is non-toxic, but if misused can pose a serious threat to humans when ingested. In order to serve liquid nitrogen properly, one has to make sure the liquid has evaporated completed. If served too quickly, risks of frostbite, cryogenic burns, or more serious issues arise.

The FSA is taking steps to make sure local enforcement officers are aware of the practices using liquid nitrogen in cocktails. In addition, they will be working with law enforcement agencies to investigate these issues further.

Colin Houston, an FSA official stated, “There are safety guidelines around the use of liquid nitrogen, especially in relation to food.” He continued to explain that, if it is used in any form, it is the business owner’s responsibility to ensure their staff is trained and educated on the risks of use.

The wine bar that served the drink to the young woman has stopped serving drinks with liquid nitrogen.

Ironically, doing so may help them avoid additional heat.

National Food Safety Lawyers Featured in Corporate Counsel Magazine

Shawn Stevens — Thu, 04 Oct 2012 08:25:21 -0600

Gass Weber Mullins, along with national food safety attorneys Shawn Stevens and Ralph Weber, is featured in the September 2012 issue of Corporate Counsel, American Lawyer Media’s national in-house counsel magazine.

The article recaps the firm’s multiple nationwide trial victories, including a one-year stretch starting in August, ’11 when Gass Weber Mullins “put together a 7-0 streak of trial wins from Maui to Maine" on a diverse mix of commercial, insurance and food safety cases.

In addition to profiling the firm's broad array of litigation work for clients generally, the article also explores the firm's recent victories for the food industry. The firm's food safety team works nationally with a vast array of food industry clients (including some of the nation’s largest food processors, national restaurant chains, and food distributors and grocers), helping them comply with complex USDA and FDA food safety regulations, responding to FDA inspections (including 483s and Warning Letters) and USDA enforcement actions, enhancing their food safety programs and systems, reducing their food safety litigation risk and exposure, planning for outbreaks and recalls, and defending against high-profile foodborne illness outbreaks and claims.

Impressively, Gass Weber Mullins is one of the only law firms in the nation with such a diverse industry-focused food safety practice.

Indeed, while consulting with nearly all sectors in the food industry on ongoing food safety issues, the firm's food safety team was also, at the same time, able to obtain a favorable jury verdict in a high-profile federal foodborne illness outbreak lawsuit tried recently in Portland, Maine.

Corporate Counsel traces the firm’s roots back to a predecessor firm where several founding partners worked in the early 1990s, and who reunited in 2004 to create a boutique firm of lawyers which strives to be the best, not the necessarily biggest.

The firm has set itself apart as a national leader which embraces technology, makes extensive use of jury research, tries high-stakes, complex, leading-edge cases, and consistently delivers outstanding results for clients throughout the country.

Food Safety Training Lab

Shawn Stevens — Thu, 27 Sep 2012 06:59:37 -0600

The International Food Safety Training Lab (IFSTL) has seen positive results after only one year of operations. The lab is designed to train scientists globally in top food testing methods.

IFSTL has also opened up its doors to trade policymakers and other industry professionals. The overall goal is to improve food safety quality on a global scale. Advocates feel that, by helping foreign suppliers better understand efforts in the US to control potential food contamination, foreign exporters can better understand how to comply with the related US requirements. In addition, policymakers can learn more information about food safety practices to make better informed policy and trade decisions.

The lab is operated by the University of Maryland along with the FDA. Both FDA scientists and guest lecturers from the industry help run the lab. The director of IFSTL, Jane Dubois explains that students get a “one-on-one interaction with FDA, USDA and EPA specialists.” Dubois also adds that, “by learning to use internationally recognized testing methods students are able to verify whether a product meets a country’s standards, even if those standards vary country-to-country, because the method [being used] is universal.”

Currently the program is working on E. coli related research, including a more detailed look into the “Big Six.” In November, the lab is planning on conducting a course on microscopic identification of ingredients that will allow students to determine whether or not an ingredient is truly what it purports to be on the product label. A second lab is set to open in England in 2013.

BPI Fights Back

Shawn Stevens — Sat, 15 Sep 2012 09:59:23 -0600

Beef Products Inc., a company which earlier this year was subject to vicious and misleading attacks by ABC News is fighting back. The company filed a lawsuit Thursday seeking $1.2 Billion in damages for losses it alleges it sustained after ABC aired a series of stories attacking the company.

The series, which drew tens of millions of viewers, has been widely rebuked by the meat industry, the USDA, senators, governors, and, perhaps most tellingly, a number of consumer food-safety advocacy groups. Articles appearing in the NY Times, USA Today, The Wall Street Journal and Food Quality Magazine (The Battle Over Pink Slime), among many others sought to defend BPI as a safe and innovative company making a healthy product. Unfortunately, by that point, it was too late to save BPI from taking substantial losses. The company was forced to suspend operations at three of its four plants.

Jim Avila, who reported the stories, has been named as a defendant in the case, as have Diane Sawyer and former USDA employee Gerald Zirnstein. Proponents of BPI contend that the withering attacks were dependent upon the use of misleading information and emotive keywords and phrases like “Pink Slime.” Today, in spite of compelling evidence supporting BPI, ABC News is not backing down. Jeffrey W. Schneider, Senior Vice President, ABC News said in response to the filing, “The lawsuit is without merit. We will contest it vigorously.”

Indiana to Publish Raw Milk Safety Standards

Shawn Stevens — Wed, 05 Sep 2012 07:41:58 -0600

Indiana will be adapting new standards for raw milk production, if the state decides to legalize the product. The Indiana Board of Animal Health (IBOAH) has until December 1, 2012 to give recommendations on raw milk policies to the Indiana Assembly.

A virtual public hearing was conducted between June 1 and Sept 1 this year. They received over 600 comments in support of raw milk. Due to this turnout, IBOAH has shared the report request by Indiana Legislature with the Governor. With the ample support, IBOAH will now include a “Plan B,” which will include adapted standards if raw milk is legalized.

IBOAH spokeswoman Denise Derrer stated, “[w]e’re basically creating a Plan B and submitting to legislators to tell them if you decide to legalize the sale of raw milk, here is the way we think it should happen.”

Indiana would join the state of Wisconsin in these new regulations. Wisconsin came up with very specific regulations making raw milk safer (if the state decided to legalize raw milk). These measures included testing for disease, plate count, somatic cell count, coliform bacteria in well water, and testing of pathogenic bacteria. In addition, Wisconsin wanted on-farm sampling, incident plans, and regulations for raw milk containers, such as labeling requirements.

Indiana was close to making raw milk legal earlier this year. Instead they opted to go with an outside advisory report. Indiana is ranked the 14th largest diary state by milk product. Notably, since Wisconsin adopted raw milk safety regulations, no raw milk bill has passed in the state legislature.

FDA's Newest Egg Guideline

Shawn Stevens — Mon, 27 Aug 2012 08:06:06 -0600

The FDA recently released its first new guidance materials since implementing the “Egg Rule” in 2009. The Egg Rule was aimed at reducing Salmonella in shell egg shells. The FDA said this week they are using guidance documents to help companies best comply with food safety rules.

In the past 3 years, the FDA has inspected many large and medium sized egg operations nationwide, with the exception being smaller egg producers. However, they will now too have to comply with the new rule.

In essence, the FDA intends to treat poultry houses and the surrounding areas as a “single biosecurity program.” With this holistic approach, it would mean that that a broad-reaching “Salmonella Prevention Plan” would have to be implemented at these facilities (which the egg rule lays out). Certain guidelines include treating food and water on the grounds and applying antibiotics to birds.

Concerns have risen in respect to smaller companies, however. Especially companies who follow a more traditional approach, meaning that they use open land. This open land can be more difficult to regulate, however. Some feel these types of producers will have a harder time complying with the Egg Rule.

Europe Hold off On Aspartame Review

Shawn Stevens — Thu, 23 Aug 2012 07:42:00 -0600

The European Food Safety Authority (EFSA) will not be releasing its “full re-evaluation” of the sweetener, Aspartame, next month as scheduled. Instead they have asked the European Commission (EC) for an extension, which would push the release to 2013. The extension would allow for consideration of new scientific data and research. As well as give time for a complete compressive risk management of the product. Originally the re-evaluation was not scheduled to be released until 2020, however the EC asked the EFSA to make an early release in 2012.

Since the requested early release date, EFSA has called on the public for scientific data for a “thorough literature review.” So far there was little data showing potential DKP (a byproduct of aspartame that has been linked to brain tumors) and other degradation products of aspartame. Therefore the EFSA would like to see more data.

Controversy has arisen over the past couple of decades over the sweetener. Some have claimed it causes health issues such as brain tumors, epilepsy, birth defects and even cancer. As of now aspartame has been proved safe. EFSA certified aspartame last in 2009. The FDA in the US first approved aspartame in 1974.

Food Safety: Seeking More Data on Antibiotics

Shawn Stevens — Thu, 16 Aug 2012 07:31:40 -0600

This week, senators wrote a letter urging USDA Commissioner Margaret Hamburg to have the FDA collect more data on antibiotics used in food animal production.

Currently, the agency does not collect data about veterinary drug usage. Even though the FDA requires reports of antibiotics sales, there is no dated collected to identify the specific animal species being treated with antibiotics, and how much they treated with (in regards to disease prevention, growth promotion, and therapeutic treatment). Many feel that, without this data, it is difficult for stakeholders to correctly assess whether the industry is actually reducing its usage of antibiotics in animals for food production. Both scientists and public health advocates agree having such data would help fight antibiotic resistance.

The letter suggests that the agency create a system for gathering and analyzing information to assess the effectiveness of new antibiotic policies. Senators offered to work with the FDA to provide additional authorities and/or resources, if needed. The letter also recognized the steps the agency is taking to address existing concerns, like revising labels and increasing oversight of antibiotics. However, they stressed the concern about continuing ambiguity in existing programs. Although there has been no official response to letter, we wait in earnest for the FDA’s view on these issues.