Food Safety Counsel : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

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.
 

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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.

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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.

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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.

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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:

1. a hazard analysis;
2. risk based preventive controls;
3. monitoring procedures;
4. corrective actions;
5.  verification procedures; and
6. 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:

1. agricultural water;
2. biological soil amendments;
3. health and hygiene;
4. domesticated and wild animals; and
5. 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.

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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.

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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. 

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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.

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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.
 

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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.
 

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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.
 

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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.
 

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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.
 

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Canada has announced a new national approach to food safety inspection. The new program would include all food commodities made in Canada or imported.

Currently Canada has a 8-tier food safety program operated by Canada’s Food Inspection Agency (CFIA). The existing programs separately regulate meat, dairy, eggs, processed products, imported and manufactured food, fresh fruits and vegetables, and fish and seafood.

The new “single system” approach would combine each the different food sectors. According to Canadian officials, it would make the program even stronger and help with budget costs. It would also create a consistent inspection model, which will provide better training and tools to food safety inspectors, Agriculture Minister Gerry Ritz explained.

The CFIA is currently seeking public feedback (from both consumers and industry stakeholders) until October 31, 2012. The CFIA will finalize plans for the single system inspection program based on the feedback it receives.
 

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Since Congress and President Obama approved the new US Food Safety Modernization Act (FSMA) in January 2011, implementation of the new law has stalled. 

This week at the International Association for Food Protection Conference in Providence, Rhode Island, participants received disappointing news.  FDA spokesperson James Gorny told attendees that many of the FSMA implementing regulations have not yet been finalized.  He explained further that, despite the lack of progress, everything under the new FSMA remains in a “deliberative phase.”

The FDA has come under recent scrutiny for failing to implement many of the regulations called for in the new legislation prior to the deadlines established by Congress.  In turn, many of the implementing regulations, while finalized by FDA, remain under “review in the Office of Management and Budget (OMB). Gorny pointed out that continuing the delay may not be the OMB’s fault, though.  They are just responsible for the coordination of federal regulation.  Instead, he suggested, that at least some of the delay might be attributable to various issues with USDA and US Trade Representatives. 

In any event, time will tell how much more time it ultimately takes for the new regulations to obtain final approval.

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The Food Safety and Inspection Services (FSIS) published its results from the first round of testing for non-O157 E. coli strains this week. The agency began screening beef trim for the “Big Six” last month, and has tested 115 samples.

Overall, 4 out of the 115 samples were positive for non-O157 STEC strains. This yields about a 3% contamination rate. According to USDA, the test results showed no real surprises, and were consistent with industry testing. Currently, FSIS is testing only beef trim, not finished ground beef products.
 

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Effective earlier this week, the government has begun enforcing the Egg Safety Rule for mid-size hatcheries. The new regulation is designed to prevent Salmonella contamination at hen laying facilities. In July 2010, the USDA enforced the same regulation on large facilities housing over 50,000 laying hens. Monday’s enforcement will affect mid-size companies that house between 3,000-50,000 hens. The regulation will not apply to small companies (under 3,000 hens) or facilities that sell directly to the consumer.

The regulation requires producers who do not pasteurize in-shell egg products to test for the Salmonella bacteria. Eggs also must be refrigerated at or below 45 degrees during storage (within 36 hours of laying). Chicks and young hens can only be sourced from facilities that test for bacteria. The facilities must also have biosecurity, rodent and pest control programs, according to the new regulation.

If Salmonella is found, affected eggs must be pasteurized or moved to a non-food use. In addition, the facility must be cleaned completely.

The FDA believes these “preventative measures would reduce the number of Salmonella infections from eggs by 60%.” According the CDC, approximately 2.2 million of the 65 billion eggs produced in the US each year are contaminated with Salmonella.

The FDA has done follow-up inspections with the larger facilities and found that most of them were in compliance with the rule. By the end of the year, the FDA hopes to perform the same inspections on mid-size facilities.
 

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Food safety concerns with hazelnuts were highlighted during a 2009 recall where nearly 30,000 pounds of nuts were recalled for potential Salmonella contamination. There have been many smaller outbreaks since, including one involving E. coli in the Midwest. Notably, before 2009, there were no reported outbreaks linked to US hazelnuts. Currently, there is no industry safety requirement. Despite this, individuals in the industry have taken many steps to enhance food safety of hazelnuts.

For example, Willamette Hazelnut Growers comprises of nearly 99% of the hazelnut producers in the country. They investigated their own processing system after the 2009 recall, finding they needed improvements in the shelling their process. The company also decided to invest in a 3rd party microbiology lab to develop improved testing methodologies. As a result, the company now sanitizes all shelled products with an organic-water-based spray. The final products are then tested for bacteria. The company also tests the facility for contamination. So far, all the tests have come back negative.

Various groups in the industry continue to make efforts to ensure food safety. Growers have implemented a set of science-based guidelines know as GAPS (good agricultural practices). Handlers have also upped their standards by adding new steps that will reduce bacterial levels and noting the efficacy of them. Polly Owen, Manager of the Hazelnut Marketing Board, stated that industry is, “continuing to aggressively pursue the best practices possible.”
 

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As of July 1, 2012, California has enforced a ban on the French delicacy known as foie gras. Chefs and restaurants were unsuccessful persuading the California Legislature to withdraw the ban. California restaurants could face fines up to $1,000.00 if they violate the new restrictions. The implementation comes from a 2004 bird feeding law. However, the 8 year delay of enforcement was reportedly “to let producers adjust.” The law restricts both production and sale of foie gras and by-products like jackets and comforters made from down.

The French delicacy is made from fatty geese or duck liver. The process of producing foie gras was seen as cruelty towards animals. During the process, the birds are force-fed cornmeal to increase the size of their livers. Former California Senator John Burton, sponsor of the 2004 bill, said it has “nothing to do with meat. It has to with animal cruelty.”

Food safety was also was called into concern with the popular dish. Some argued that the force-fed birds could develop a blood-borne bacteria that could cause pre-mature death. Yet, the USDA rejected the claim.

Many of those in the culinary industry are not backing down without a fight. Various California groups have asked the federal courts to strike down the ban on the basis of its impact on interstate commerce. The court has stuck down a few similar bans due to the same argument. Another issue that has arisen is the law’s ambiguity. It does not give any standards for weight, volume, or caloric values.

The controversy over the popular food product continues nationwide. Notably, Chicago recently over-turned their ban on foie gras.
 

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In the past year, Denmark has experienced some of the lowest reported Salmonella cases in any developed country. Denmark set a personal best in 2011, with the lowest rate since the 1980s. After a spike of cases in the 1990s, the government decided to implore some of the toughest control measures to combat the issue.

For example, in environmental testing of chickens, if one bird tests positive for Salmonella, the whole flock is considered to be contaminated. Denmark also bans selling of fresh-eggs from any Salmonella-positive-laying flock. The country also requires all imported eggs to be completely Salmonella free. Notably, not a single case of Salmonella reported in 2011 was caused from chicken. Moreover, no Salmonella outbreaks (cases involving 2 or more illnesses) were traced back any Danish meat. Rather, the few Salmonella cases (non-outbreaks) were linked back to both Danish and imported pork.

In 2011, there were less than 300 cases of Salmonella Enteritidis (SE) in the country. In turn, approximately 70% of the reported cases were from citizens actually eating outside of the country. Danish authorities could not link the food source in about 25% of the cases. Those sources were most likely from food sources not regularly checked for Salmonella (i.e. fruits and vegetables).
 

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The USDA’s Food Safety and Inspection Service (FSIS) will be launching an updated testing system for meat, poultry, and eggs.

The new system will allow agency to test for more drugs, pesticides, and potentially harmful chemicals at one time – versus individually. The Secretary of Food Safety, Dr. Elisabeth Hagen, stated that “the new testing methods being announced will help protect consumer from illegal drug residues in meat products.” She stated further that “testing for more compounds will allow USDA to identify and evaluate illegal drug residues more effectively and efficiently.” The new method will be able to test for 55 pesticide chemicals, 9 types of antibiotics, various metals, and over 50 other chemicals.

In turn, the data from the enhanced testing will be collected, analyzed, and published by the National Residue Program (NRP). NRP looks for both legal and illegal compounds. Examples include pesticides, environmental contaminants, veterinary drugs, and hormones. FSIS also claims that the new method will be “more efficient and conserve resources, while also providing better results.”

The FSIS will also be expanding its annual samples of slaughtered animals. If a sample turns out positive for residue, the supplier will be notified by the FDA and they could be subject to further testing.
 

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On Friday, June 29, 2012, the Appellate Body of the World Trade Organization (WTO) ruled against the US’s country-of-origin labeling (COOL) law.

The WTO felt that it discriminated against meat importers, specifically the US’s neighbors, Canada and Mexico. However, the WTO did agree the US consumer should have the right to know about the origin of their food. Therefore, the ruling included a requirement that the US amend its labeling law to ensure it no longer poses “a technical barrier to trade.”

This ruling stems from the 2009 implementation of the US law. In response to this action, Canada and Mexico filed independent appeals with the WTO, citing technical barriers and unfair trade measures. Canada and Mexico are the two biggest importers of meat to the US.

In its decision, the WTO stated that the COOL labeling laws give U.S. domestic beef, pork, and chicken an unfair advantage over imported competitors. In turn, the Canadian Cattleman’s Association said the law cost the beef industry $400 million a year, and the pork industry over a $1 billion. A Reuter’s study found that Mexican cattle are valued at $95 lower than US raised cattle.

After Friday’s ruling, both the US and Canada had positive statements about the decision. Ron Kirk, a US Trade Representative said that the “[decision] affirmed the US’s right to adopt labeling requirements ... [and] confirms that families can still receive information on the origin of their meat and food products.” The Canadian Cattlemen’s Associate stated that “upholding the part of the panel that confirmed the discriminatory nature of COOL, the Appellate Body’s final decision has provided an important victory for Canadian Cattle producers.” We wait to see whether, and to what extent, the U.S. labeling laws will be amended.
 

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The Scottish government has recently decided to break away from the United Kingdom’s Food Standards Agency (FSA). Instead, they will be setting up their own food standards agency. The new agency will be responsible for food safety, food standards, nutrition, food labeling, and meat inspections.

This action stems from the 2010 decision by UK’s government to move food labeling and standards from the FSA to the UK’s Department of Health of Environment, Food, and Rural Affairs. After this decision, Scotland decided to conduct research to decide what the best option was. The research panel published their report in April, advising that Scotland should go “independent.” Scotland’s Health Minister, Michael Matheson stated, “the changes in England removed significant capacity in the FSA’s nutrition and labeling functions for Scotland and needed to be address.”

The new agency will allow Scotland to tackle in-house emerging diet and foodborne illness issues. In addition, the move will help Scottland ensure that the food and drink industry of Scotland will continue to have a strong reputation for safety and quality.
 

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In many jurisdictions, food preparation workers are required to wear food-service gloves to prevent contamination and keep food safety quality in-check.

However, there has been recent buzz on how safe those gloves really are. Many argue the gloves are only effective when worn by clean hands. They further argue that gloves give employees a false sense of security and become automatic and ubiquitous. The purpose of the gloves is to protect against disease transfer to consumer like Hepatitis A, norovirus, E. coli, and other foodborne illnesses.

In studies conducted by the Journal of Food Protection in both 2007 and 2010, results concluded that gloves may not be as effective as once thought. The 2007 study found that “hand washing and glove use were related to each other…hand washing was less likely to occur with activities in which gloves were worn.” The 2010 study produced similar findings, noting that “glove use can create a false sense of security, resulting in more high-risk behavior.” The study also found the occlusion of the skin can create the prefect breeding ground for “microbial proliferation” and can “increase pathogen transfer onto foods.” Interestingly, they also found twice as much coliform bacterium on tortilla samples handled by gloves versus bare hands.

Another issue that has risen is the cost of using disposable gloves. Some argue that those resources could be spent alternatively to invest in kitchen improvements like automatic or food-pedal operated sinks to give works adequate time to wash hands properly.

However, the problem isn’t the gloves, but what workers do while wearing the gloves. Some of those actions can contaminate gloves, which in turn can contaminate food. In 2006 and 2007, studies conducted by the Center for Disease Control found hand-washing requirements by employees wearing gloves were not being adequately met. Those workers in the study only washed their hands in 27% of the activities that recommended hand-washing.

Denise Korniewicz, Dean of Nursing at the University of South Dakota explains, “the best way to prevent transmission of bacteria, virus, or other bugs is to wash hands thoroughly.” In correlation, the CDC recommends decreasing the amount of times a worker is put into a scenario where he or she has to wash his or her hands. This means revising food preparation methods and decreasing handling of raw material like meat and fish. The food service industry still relies on the glove-method. It is necessary in sectors like in raw meat and fish preparation. The gloves do help avoid cross-contamination, if used properly.

No one product will keep food safe. However, regular and thorough handwashing, along with a conscious use of gloves will keep food safety risks down.
 

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China announced a new 5-year food safety program to address continuing concerns about its food industry. According to reports, the government will be updating, reviewing and eliminating any old and overlapping regulations and standards. Many standards and regulations currently contradict one another. This is a result of multiple government agencies regulating the industry. There will be 14 different government departments including the Ministry of Health, Ministry of Science and Technology, and Ministry of Agriculture, that will work together to revamp regulations and standards by 2015.

The government will prioritize safety standards for dairy products, infant food, meat, alcohol, vegetable oil, seasoning, health products, and food additives. They will also take extra steps to improve testing standards for contaminants, food additives, microorganisms, pesticides and animal drug residue.

The new program comes after nationwide concern about food safety in China. Indeed, suspect food from China has been involved in many recent food safety headlines. Scandals have included mercury findings in baby formula, produced by one of the biggest dairy companies in China; clenbuterol involving pork; and overall concerns about Chinese food products.

Reportedly, the plan will add 269 new national food standards and require more supervision and harsher consequences for violators. The Chinese government released a statement acknowledging the difficulty of the task; however, overall, they are hoping to simplify the complex and confusing system. Time will tell whether they get it right.
 

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The previous Farm Bill was set to expire in September of this year, this week the Senate passed the new Farm Bill 2012. However, the new bill has come under scrutiny. While some feel the bill is a step in the right direction, others feel it sends the wrong message.

This month a letter was submitted by the Environmental Work Group (EWG) expressing concerns about the content of the bill. The overall consensus was that while the USDA is encouraging healthier foods, the Senate is seeking to invest money into more processed types of food instead. The Farm Bill assigns most of its funding to commodity crops (such as corn, rice, soybeans, and wheat), which of course are basic ingredients for processed food. Kari Hamerschlog, Senior Food and Agriculture Analyst for EGW, explains the point of the letter was to “urge Congress to stand up for healthy food and farm bill.” Hamersclog also expresses concerns that the bill is not addressing food and farming challenges or what the American public expects from the food and farming industry. She points out a national poll conducted in July 2011 found that 78% of respondents said, “making nutritious and healthy foods more affordable and accessible should be top priority in the farm bill.”

Hamerschlag stated further that fruit and vegetable growers are vital for “improving America’s nutrition and reducing the costly toll of diet-related diseases.” Failure to invest in healthy foods such as these, she argued, could potentially lead to increased health-care costs, and decrease accessibility due to affordability.

However many support the new Farm Bill. United Fresh Produce Association (UFPA) gave Senate approval and encouraged them to pass it as soon as possible. Food Safety experts feel that it the bill will have a positive effect on food safety. Supporters of the bill feel that no bill will ever be perfect, but this bill provides steps in the right direction. Many of the measures in the bill give farmers a safety net that they might not have otherwise.

The legislation was passed with 64 votes on June 21, 2012. The bill will cost $500 billion over a 5-year span, and will now go on to House of Representatives for final approval.
 

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The Indiana General Assembly has appointed the Indiana State Board of Animal Health (BOAH) to study the topic of raw milk. BOAH will be conducting a 3 month long “Virtual Public Hearing” from June 1 to September 1 to gather information. They will then produce a report by December 1(if not sooner) with the gathered information. Indiana is the first state to conduct a compressive study of raw milk since the 2010 raw milk report. The 2010 report helped develop regulations to ensure safety of raw milk.

Currently, Indiana law bans the sale of raw milk. However, farm families locally are permitted to consume raw milk from their farms. Indiana is one of20 states that bans the sale of raw milk entirely. However, 30 states allow non-pasteurized sales in some fashion.

BOAH feels their overall task will be to decide whether or not the sale of raw milk should be permitted in any form. They are hoping for a strong turnout with the virtual hearing. Terry Philibeck, BOAH’s dairy division manager, explains, “we wanted to find a way for every Hoosier to participate.” The virtual hearing allows citizens to participate around their schedules.

To participate in Indiana’s raw milk virtual public hearing, click on the following link: www.boah.in.gov. For those who do not have internet access, you can submit commits via US Mail to: BOAH Attn: Raw Milk comments, Discovery Hall, Suite 100, 1202 E 38th St., Indianapolis, IN 46205.
 

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A study by the Marshfield Clinic Research Foundation concluded that untreated water systems can carry human viruses in drinking water. The study found that water that was not disinfected in 14 communities tested positive for human viruses. in turn, the study concluded that people who live in communities with untreated water are likely being exposed to waterborne illnesses and other harmful health risks. This is one of the first studies to link viruses in public water supplies to effects on human health. Click on the following to view the Marshfield Clinic Research Foundation Study.

One virus commonly found during the study was norovirus. Norovirus is one of the most contagious viruses that can spread person-to-person. Notably, the study also blamed the virus for nearly 2/3 of the illnesses in children under the age of 5 years old.

The study linked the source of the contamination to leaking wastewater from sewers. The wastewater contained human waste viruses that traveled through the soil and into the groundwater. The groundwater was then used as a source of drinking water in the affected communities. Notably, groundwater is the most common way communities receive their drinking water.

The study was initiated after the Wisconsin Department of Natural Resources (DNR) proposed regulations to require all communities to disinfect their systems. This regulation never passed and became a heated topic. Some felt that it should be up the individual community to decide whether they should disinfect their water systems, while others felt there should be a statewide mandate based on the federal Safe Drinking Water Act.

In total 66 Wisconsin communities do not disinfect their water systems. The study’s findings were 4,500 times higher than the EPA’s acceptable risk. The DNR still recommends disinfecting water supplies, despite the rejected regulations. The EPA announced, however, that they will require monitoring of these communities between 2013 and 2015.
 

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The FDA has denied a petition to allow food processors to rename high fructose corn syrup (HFCS) as “corn sugar.” The petition, pending since 2010, was filed by the Washington DC Corn Refiners Association (CRA). Since filing the petition, the CRA has also been spearheading a national campaign to promote the new name.

The CRA and supporters of the name change claim the FDA was too quick to make decision. They claim that the FDA ignored scientific evidence that HFCS is, indeed, a form of sugar and thus has the same basic nutritional make-up of sugar. Therefore, CRA has argued, HFCS is “sugar.” The CRA has also asserted that HFCS is an already confusing name for consumers, leading them to think that the product is worse than sugar.

FDA’s Director of the Center for Food Safety and Applied Nutrition, Michael M. Landa argued against the name change. He felt calling HFCS “sugar” would not be an accurate way of identifying, describing, or characterizing the product. Landa also argued that consumer confusion could be increased given existing FDA regulations. He used the example of categorizing of “dextrose” as “corn syrup.” The FDA would then have to change “dextrose” to “corn sugar” which could confuse consumers, especially those who have health problems associated with dextrose. Landa also highlighted the implications of a name change for those individuals who may be stricken with fructose intolerance. He felt by renaming “corn syrup” to “corn sugar,” those individuals may be lead to the assumption that it is ok to consume products with corn sugar. Overall, Landa’s arguments focused on the agency’s interest in protecting consumers health by protecting them from additional confusion.

Ultimately, the FDA stated that their ruling is consistent with basic understanding held by consumers of sugar and syrup. Notwithstanding the FDA’s decision, the CRA plans to continue its efforts in pushing for the name change.
 

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The USDA will soon begin testing for six additional strains (the “Big Six”) of E. coli that they have not previously tested in meat processing facilities. This is a result from extensive research on different outbreaks involving the strains in the past few years.

The “Big Six” have been traced to outbreaks and illnesses in the recent years throughout the country. Most frequently in cases linked to sprouts and lettuce. In 2010, for the first time, the “Big Six” strains reportedly caused more illnesses combined than the O157:H7 strain. Patricia Griffin, senior scientist at Center for Disease Control and Prevention, estimated that the six strains were responsible for “70% of the country’s illnesses linked to E. coli."

The meat industry is raising concern about the new law. They feel they are being targeted unjustly, based on several arguments. One that the presence of E. coli does not mean it will cause illness. Most strains of E. coli are harmless, only some produce toxins that sicken people like the O157: H7 strain. Also, the American Meat Institute points out the recent outbreaks related to the “Big Six” do not even involve beef. In addition, the industry is also worried about the amount of time that testing will require. In particular, many companies are expressing concern that the amount of time it takes to receive results will shorten the meat’s shelf-life.

With that said, however, the need for substantial additional testing may never fully materialize. This is because FSIS may ultimately allow existing testing to serve as an equivalent for the Big Six. In essence, to the extent existing tests which are being used to control for O157:H7 will also presumptively indicate the possible presence of non-O157 STECs, these tests may ultimately be deemed sufficient for non-O157 STECs as well. Debate on this issue is continuing.

Elisabeth Hagen, USDA’s undersecretary of Food Safety explains, “What we’re doing is about prevention.” The USDA has been taking greater steps in preventing food borne illness in the recent years. This past September, officials felt that they could classify the “Big Six” as “adulterants” or contaminates.

This classification, of course, requires the government to begin testing for them. What remains to be seen is how the new rules and testing requirements, if any, will be enforced on industry.
 

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At the urging of FDA, Diamond Pet Food has expanded their recent pet food recall.

The company has now been asked to include certain types of dry cat food, in addition to dog food. There is no detailed information on which brands of cat foods that could be impacted. The recall initially began in April on dry dog food. Since then the company has announced several different recalls on products manufactured between December 2011 and April 2012.

The pet food has allegedly been linked to cases of salmonella in both animals and humans in the US and Canada. The federal government traced 14 cases of the salmonella back to the pet food this past month. In addition, a Canadian newspaper reported two cat deaths and one cat illness after the animals ate the food at a local shelter.

The FDA launched an investigation into Diamond Pet Food after the first recall last month.The agency allegedly  linked the problem to the company’s facility in Gaston, South Carolina.

The FDA's initial report found “all reasonable precautions are not taken to ensure that production procedures are not to contribute contamination from any source.” The FDA blames the screening process as the possible culprit.

The FDA also announced many alleged violations or varying degrees of seriousness, including handling equipment with bare hands, lack of hand-washing stations, and damaged equipment. Due to the open investigation, information available to the public is limited. This is a good example of how the FDA is becoming (and will likely continue to become) stricter on pet food companies.

Diamond Pet Food is moving forward after the recent recalls. They have kept their hotline open for consumers to ask questions. In addition, the company has voluntarily shut down their Gaston facility to clean and institute new safety procedures.

Recent FDA testing at the site found no contamination. In total 13 brands of Diamond Pet Food are affected (Chicken Soup for the Pet Lover's Soul, Country Value, Diamond, Diamond Naturals, Premium Edge, Professional, 4 Health, Taste of the Wild, Apex, Kirkland Signature/Kirkland's Signature Nature's Domain). Brands manufactured at the Gaston plant have issued separate recalls of the products produced: Natural Balance, Solid Gold, and Wellness.

The FDA investigative efforts and resulting recalls should serve as a wake up call to the pet food industry -- moving forward, we expect the FDA to begin focusing nearly as much attention on pet food as the agency has given other segments of the food industry.

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The Greeley Farmer’s Market in Colorado has announced a new requirement for participants. Vendors will now be required to carry at least $600,000 worth of general liability and product liability insurance. In the past there were no requirements for insurance coverage.

The new requirement follows a listeria outbreak last year that killed as many as 30 people due to contaminated cantaloupes sold from a local farm in Colorado. The regulation would act as a security measure to potential foodborne illness problems. Product liability insurance protects individuals who are producing goods for sale and would protect them in the event the product would cause harm to the user. There have been mixed responses to the new requirement.

While there is a general understanding of the need for such insurance, some feel the costs outweigh the benefits. The concern is that the requirement will hinder affordability, growth, and overall diversity of the market. These concerns come from the burden being placed on small-producing farmers who’ve expressed that they will not be able to participate with the new requirement. Farmers who produce at greater quantities already have regulations on the insurance they carry.   In addition, most make enough profit to afford the premiums with little impact. One local farmer expresses “$420 for a year is so far the cheapest” premium he can find, inferring it is not cheap to afford the insurance.

Small farmers may have a hard time affording the insurance because they produce fewer amounts and make less profit. Having to incur this new expense, leads to another concern that the cost of the product will increase. The thought is since the cost to grow the product increases, so will the amount the good costs to the consumer. The farmer will have to compensate for the increase of production. The overall concern is this measure will turn away the number of vendors who will participate in the market since many of them are small-growers.

Farmer markets highly consist of these small-based farmers. If these growers are not able to participate the selection of goods will decrease. While there is no immediate impact yet, the market officially opened this past weekend with the new regulation implemented.
 

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The Cottage Food Act of Washington that was passed by the legislature last year could go in effect as soon as this summer. The Act would benefit home-based entrepreneurs who want to sell their own baked goods.

The Washington State Department of Agriculture would administer the new law. The act would allow home-bakers to apply for licenses to sell their products (or simply, operate a legal home bakery). Currently, it is illegal the sell your own baked-goods, if they are not produced in a commercial kitchen in the state of Washington.

The Act would regulate many aspects of this growing movement. Only certain “lower-risk” foods would be encompassed in the act. These foods include breads, cookies, granola, cakes, nuts, jellies, and jams. The Washington Department of Agriculture would require a once-a-year inspection. To pass inspections kitchen surfaces and floors must be smooth. In addition, pets and children under the age of 6 years old must be kept out of the kitchens.

However, the kitchens do not necessarily need to be equipped with amenities associated with commercial kitchens. Not only is the environment of the kitchen regulated, so is the revenue. Since the Act is supposed to boost start-up business without costs of overhead, the amount of revenue made is capped. The Act would limit a business to $15,000.00 of revenue. Though this may seem like a low number, advocate and baker, Felicia Hill, explained, “the [$15,000.00] limit is better than the $5,000.00 original budget proposed in the Legislature.”

The revenue and environment are not the only factors regulated, so is the distribution. Cooks would only be allowed to sell to the consumer-directly (i.e. out of their homes or at farmer markets). They would not be able to sell by mail order or over the internet.

The Washington Department of Agriculture is expecting a positive turn out. Over 250 home-based businesses in the state have applied for the license. They are estimating to have eventually over 1,000 business to apply.
 

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In our last column, I discussed how current FSIS policy (which invariably reacts critically to any positive testing results) discourages companies from aggressively testing to find pathogens in their products.

When adulterants are found in ground beef products, the results must be shared with FSIS and determinations made regarding which products are potentially affected and how they will be disposed. Unfortunately, in many instances, FSIS will use a company’s positive findings as a catalyst to aggressively and sometimes unreasonably second-guess its actions and response. 

This costly and unwarranted burden has, in many cases, discouraged the development and creation of truly effective testing programs by industry.

Now, FSIS is in the process of reviewing a petition from the Center for Science in the Public Interest which asks the agency to declare numerous strains of Salmonella as adulterants in raw meat and poultry.

The agency’s response to recent questions on this issue suggests that FSIS is seriously considering the policy. Dan Engeljohn, assistant administrator FSIS’s Office of Policy & Program Development, recently told attendees at an annual meat industry conference that FSIS is currently “assessing [the policy], and how we’d go forward if we were to adopt it.”

This sounds to me like the decision has already been made.

As FSIS considers it next steps, however, it needs to maintain a reasoned approach which recognizes the fact that it is currently impossible, given current technology, to completely eradicate ubiquitous organisms from raw beef and poultry products.  For this reason, whatever policy FSIS develops, the agency should at the same time reassess how it will react and respond to processors who aggressively test to find Salmonella (or other pathogens) in their products.

From my experience, the majority of beef processors would welcome additional controls aimed at reducing the numbers and levels of pathogens in incoming raw trim used to process hamburger.  If, however, the agency continues to penalize (rather congratulate) processors who test for and then find these pathogens in their finished products, then our food supply will not likely become any more safe.

Thus, in my view, as FSIS considers its policy going forward, the agency should also recognize that it has an unparalleled opportunity to develop and embrace rules that adequately enforce the new standards at slaughter, but also encourage (rather than discourage) additional testing.  If FSIS can incentivize the creation of new cutting-edge programs designed to find pathogens in products before they reach consumers, as opposed to destroying any incentive to test and find (through its often oppressive reaction when pathogens are found), then the agency will have substantially advanced the calling of food safety. 

So, as we wait with interest to see whether FSIS will declare Salmonella as an adulterant, we also wait to see if FSIS will continue to unfairly (and, in my view, improperly) test the tester.

** This article, authored by Shawn K. Stevens, is also featured in the April edition of the National Provisioner.

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Microbiological sampling can be an effective tool to help companies verify that their interventions are working. But how much testing is really expedient given the current food safety climate?

Today, many companies are testing for Listeria, Salmonella, E. coli O157:H7, generic E. coli, various other indicator organisms and, now, six additional STECs. Many companies perform raw material sampling, environmental sampling, equipment sampling and finished product sampling.

Even so, some argue, it is still not enough.

Unfortunately, not even companies on the cutting edge of food safety, who have implemented state of the art testing programs which far exceed FSIS requirements, are immune from outbreaks, recalls and criticism. This is because testing can never provide a one hundred percent guarantee that a product is sterile. Contamination in foods is by nature quite sporadic and, thus, difficult to detect.

Although finished ground beef product testing is not mandated by federal law, many companies nevertheless embrace finished product testing as a means to better monitor their processes and to further enhance the safety of their products. These companies not only deserve our commendation, but they also deserve to be treated better by USDA.

This is because current USDA policy discourages companies from finding pathogens in their products. When E. coli O157:H7 is found, the results must be reported to USDA, and determinations made regarding which products are potentially affected and how they will be disposed. Unfortunately, in many instances, USDA will use a company’s positive findings as a catalyst to aggressively second-guess its actions and response.

Indeed, rather than allowing processors who test and find to quickly address those findings and divert affected product, the agency too often responds with additional regulatory intrusion and unwarranted criticism. Moreover, the more companies test, and the more they find, the more onerous and oppressive agency intervention can and potentially will become. Similarly, in the unfortunate event that a company (despite its best efforts) finds itself associated with an outbreak or recall, USDA is virtually certain to conclude in a Notice of Intended Enforcement issued following the recall that the companies’ testing program was somehow deficient – no matter how good the program actually was.

This reality, unfortunately, demonstrates the glaring disconnect between the science of food safety and the expectations of regulatory inspectors.

Thus, although companies that perform more testing stand a far better chance of finding contamination and reducing their risk of being associated with an outbreak or recall, they cannot reduce the risk entirely. Thus, to encourage more (not less) sampling, USDA should begin adjusting its policies to create more (not less) incentive for companies to test to find.

If we are to make further strides in food safety, we must develop science-based solutions which examine the root causes of contamination. And, USDA needs to take a closer look at how it responds to processors who aggressively test their finished products. In the end, it needs be pathogens – not companies doing the right thing – who feel they are being tested.

** This article, authored by Shawn K. Stevens, is also featured in the March edition of the National Provisioner.

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The USDA’s Food Safety and Inspection Service ("FSIS") recently announced they will extend the agency’s implementation date for non-O157:H7 STEC sampling and testing to June 4, 2012.

The extension, according to FSIS, was announced to give establishments additional time to validate their test methods and detect non-O157:H7 STECs prior to entering the stream of commerce.

As part of its zero-tolerance policy for E. coli O157:H7, FSIS will begin sampling both domestically produced and imported raw beef manufacturing trimmings and other raw ground beef components for the serogroups O26, O103, O45, O111, O121 and O145.

In a statement, AMI Executive Vice President Jim Hodges applauded the temporary delay, but argued again that additional research is still needed given the significant shift in agency policy.

“Even with a 90 day delay, imposing this new regulatory program in June puts the cart before the horse and will needlessly cost tens of millions of federal and industry dollars – costs that likely will be borne by taxpayers and consumers. In short, the policy is not likely to yield a significant public health benefit and given that research should precede and dictate the policy, the process that FSIS has followed in this matter is no way to develop good public policy.”

In the end, significant questions still exist regarding the prevalence and virulence of non-O157:H7 STECs in beef products. Time will tell whether the substantial resources being directed toward these new pathogens will, indeed, translate into a substantial improvement in public health.

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On January 4, 2011, President Obama signed the Food Safety Modernization Act ("FSMA").

Since the FSMA was signed into law, the FDA has made significant progress in a number of areas. Although not all of the changes expected under the FSMA have gone into effect, many of the changes have already been implemented.  In the past year, for instance, the agency has implemented the following initiatives quickly and with minimal confusion:

• Consumer-Friendly Web Search for Recalls. FDA launched a more consumer-friendly recall search engine on the FDA website.

• Guidance to Seafood Industry on Food Safety Hazards. FDA issued its updated guide to the seafood industry on hazards associated with fish and fishery products and appropriate controls for those hazards.

• Administrative Detention of Foods. Allows FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed. FDA has begun using this authority.

• Prior Notice of Imported Food. FDA issued an interim final rule that requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

• Joint Anti-Smuggling Strategy. FDA and the Department of Homeland Security issued a joint anti-smuggling strategy to help to identify and prevent smuggled foods from entering the U.S. and posing a threat to national security and consumer safety.

• Fee Schedule. FDA announced the fiscal year 2012 fee schedule for certain domestic and foreign facility re-inspections and for failure to comply with recall orders.

• Authority to Suspend the Registration of Food Facilities. FDA has the authority to suspend the registration of food facilities to prevent the import and export into the U.S. in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

• Product Tracing Pilots Launched. FDA announced that the Institute of Food Technologists (IFT) will carry out two new pilot projects aimed at enhancing the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.
   

Reportedly, the FDA has also met the FSMA mandate for foreign inspections. For domestic inspections, the FSMA mandate is based on a 5-year time period.

In the past year, FDA has defined its high-risk and non-high-risk domestic food facility inventories and in FY11, FDA and various state partners conducted more than 20,000 food facility inspections. At this rate the Agency will likely meet the domestic food inspection frequency mandates contained within FSMA. In addition, FDA is developing new risk-based approaches to domestic inspection to maximize public health benefit.

Communication and outreach have also played an important role as FDA implements the various FSMA provisions.

• FDA has participated in more than 350 meetings with industry leaders, farmers, consumers, public officials, and academics.

• On produce safety, FDA has worked very closely with USDA, which has an established relationship with farmers, and taken part in 14 farm tours across the country to gather input on how the proposed rules can work feasibly across the diversity of commodities and growing conditions and practices.

• FDA, the US Department of Agriculture, and the National Institute of Food and Agriculture entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training and other projects.

• FDA held three public meetings on preventive controls, import provisions, and changes to inspection and compliance programs in a preventive controls environment.
• FDA has participated in more than 70 meetings globally to discuss the international impact of FSMA. This includes trips by the Deputy Commissioner for Foods to China, Mexico, Canada and the European Union.

• FDA participated in, and helped fund, the establishment of the Produce Safety Alliance and the Food Safety Preventive Controls Alliance to help industry, especially small and very small firms, to comply with the requirements.

• FDA provided information to the business community through the extension services of 49 land-grant colleges and universities.

• FDA established a FSMA webpage that now has more than 10,000 subscribers, includes more than 100 Frequently Asked Questions by topic, and features videos, webinars, presentations, and print materials.

While the impact of many of the changes implemented by FDA to date have been relatively minor, some of the most comprehensive regulatory changes – such as the requirement that food companies adopt written food safety plans – are still to come. We, of course, continue wait in earnest to see, exactly, what the agency has in store.

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With the passage of the Food Safety Modernization Act (FSMA), FDA has been tasked to cultivate approximately 50 new rules, guidance documents, reports and studies – all of which all must be implemented within very specific timeframes.

In turn, while many of the new provisions have yet to be implemented, numerous milestones (despite popular belief) have already been met. These milestones have also, at least in part, touched upon many of the most significant changes under the new law, including increased agency authority, new requirements for preventative controls and new import standards and expectations. Although many of these topics (along with additional anticipated developments still lurking just over the horizon) will be discussed in greater detail in our next issue, we wanted to provide a quick primer of both where we’ve been and how much further we still need to go.

Notably, FDA’s implementation of the FSMA first started gaining real momentum three months after passage (in March 2011), when FDA hosted a public meeting focused on the legislation’s new import safety requirements. The meeting attracted more than 500 attendees and, although many topics were discussed, the debate focused mainly on four key import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; the Voluntary Qualified Importer Program; and the Foreign Supplier Verification Program. In essence, these new initiatives will require food product importers to ensure that each of their foreign suppliers are following the same standards that are and will be expected of food processors here in the U.S.

It became clear from the meeting, however, that setting such standards, and then ensuring compliance, will create significant challenges. The amount of food that is imported into the United States has been steadily and rapidly increasing for years. This is especially true with high risk foods like fruits, vegetables and seafood. In turn, much of the food imported annually originates from countries (and economies) without the resources or infrastructure to develop and implement the robust food safety programs which are taken for granted here in the United States.

Nevertheless, the FDA has announced that it will expect those U.S. food companies who chose to import, process or sell foreign products to ensure not only the safety of the products themselves, but to also ensure that their foreign suppliers are complying with each of the regulatory requirements under the FSMA. These requirements, for instance, will mandate that each foreign supplier implement a written food safety plan that satisfies the requirements of FDA.

In the weeks following the March 2011 import safety meeting, FDA then began focusing additional effort on widening it regulatory powers here at home. On May 5, 2011, FDA issued a new rule allowing it to administratively detain foods which the agency has reason to believe may be adulterated or misbranded. The new rule went into effect on July 2, 2011.

Effective the following day, on July 3, 2011, the FDA then gave itself additional authority, which allows the agency to suspend the registration of regulated U.S. food facilities. This new power gives FDA the ability to suspend (or threaten to suspend) the registration of any regulated food facility if the facility is producing food which, in the judgment of the agency, presents a reasonable probability of causing serious adverse health consequences or death.

Since July, the agency has been moving forward on other fronts as well. With the assistance of the Department of Health and Human Services (HHS), FDA has also begun to develop and implement a joint-anti smuggling strategy to identify and prevent smuggled foods from reaching the United States. HHS and FDA report that they will be partnering with the Department of Homeland Security and the U.S. Customs and Border Patrol to implement multi-phase strategies and technologies to counter existing and emerging smuggling threats. The threat of smuggled food, of course, extends all the way from consumer safety to national security and terrorism.

And, as many of you know, the FDA was also accepting public comment – through last August – on the docket for “Preventive Controls for Registered Human Food and Animal Food/Feed Facilities.” According to FDA, the comments received will be used by the agency to help shape the new regulations which will mandate that all regulated food facilities implement written food safety plans no later than July 2012. While many industry groups have taken advantage of the opportunity to share their perspectives with FDA, substantial uncertainty continues to exist with regard to not only what the new standards will specifically say, but how they will be uniformly and fairly enforced across the vast array of differing food processing operations across the country.

In this regard, despite the agency’ progress on many fronts, virtually all regulated food companies continue to wonder what is going to be asked of them and when. Although we have talked generally in previous articles about approaching deadlines and anticipated expectations, it will remain difficult for any food company to effectively prepare for the new anticipated regulatory changes until FDA actually publishes the new requirements.

Additionally, in the absence of any clear direction yet from FDA regarding what, specifically, the new regulations with say, many small and medium-sized companies remain worried about their long-term survival. Given the unprecedented increase in new FDA regulation triggered under the FSMA, many small businesses (some already struggling as a result of the lethargic economy) are fearful that the investments which will be required to ensure compliance could ultimately impact their ability to compete and potentially lead to financial collapse.

Indeed, Kathy Means, Vice President of Government Relations and Public Affairs at the Produce Manufacturer’s Association, recently echoed such fears, warning that while “[e]very business must have a food safety plan, these plans should be adaptable and not burdensome to small businesses.” After all, Means concluded, “the reality is that pathogens simply do not respect the size or type of an operation.” Thus, we remain hopeful that the public comments already received by FDA from industry and key stakeholders will lead to practical standards which all companies can both efficiently and effectively implement to improve their food safety programs.

In spite of the progress already made by FDA, the implementation of effective regulations (whatever their form) remains a significant challenge. In addition to the difficulties associated with developing a single set of clear and effective standards, FDA will need significant additional funding to properly, uniformly and fairly enforce those standards. Already, FDA has expressed frustration over the contrast between Congressional expectations and the limited funding which may ultimately be allocated. The agriculture appropriations bill recently passed by the House of Representatives, for instance, would decrease funding to the FDA next year by $87 million.

With that said, the FDA, seems to recognize the breadth of changes it faces, and now has more than two dozen separate working groups focused on implementing the FSMA. And, at the end of the day, we remain confident that FDA is doing all it can, and trying to do it well.

As with any piece of monumental legislation, especially one which directly affects every consumer in our nation, FDA has wisely solicited assistance directly from the food industry in a sincere effort to make the coming changes workable for all.

In the meantime, as we are driven by FDA further down this new regulatory path, we simply hope the continuing journey remains as smooth and bump-free as possible.
 

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The FDA recently announced the implementation of a fully-staffed network dedicated to rapidly responding to human and animal foodborne illness outbreaks. This group is called the Coordinated Outbreak Response and Evaluation (CORE) Network.

Kathleen F. Gensheimer, formally Maine’s state epidemiologist, will lead CORE, in the new position of Chief Medical Officer/Outbreak Director. Under the leadership of Gensheimer and the FDA, CORE will be staffed by epidemiologists, veterinarians, microbiologists, environmental health specialists and risk communications specialists.

Their primary objectives of the new group are to: (1) rapidly respond to emerging outbreaks; and (2) research past outbreaks in order to develop new preventative methods in the hopes of mitigating or preventing future outbreaks.

Gensheimer, quoted in the FDA’s press release, stated, “A real benefit of the network approach is enhancing communication and coordination with federal, state and local food safety agencies, as well as industry and consumers. Given my background at the state public health level, this is a major priority for me.”

Before CORE was created, there was no centralized staff, but rather various offices of the FDA that responded to incidents. CORE, FDA is hopeful, will provide a more in-depth process of monitoring and evaluating foodborne illness outbreaks as well as facilitating faster responses when outbreaks do occur.

The lack of coordination between the multiple governmental agencies involved in foodborne illness outbreaks has, historically, resulted in a host of problems. In some instances, these have included errors in trace back investigations conducted by local health department personnel which have prevented the true source of an outbreak from being identified.

The FDA confirms that CORE will work closely in all outbreak investigations with the Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), as well as public health and agriculture agencies.

“The centralized staff of the CORE Network will work closely with FDA’s field emergency response coordinators and the investigative and analytical teams in the District offices and associated laboratories,” said Dara Corrigan, associate commissioner for regulatory affairs. “Working together will help to both standardize and strengthen how we conduct foodborne outbreak activities in the field.”

Ideally, CORE will fundamentally change the manner in which foodborne illness investigations are conducted in a way that allows for faster resolutions, more effective trace back and most importantly, fewer illness.
 

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With the passage of any new legislation, there is bound to be a period of lengthy adjustment. When that legislation is as broad and sweeping as the Food Safety Modernization Act (“FSMA”), the period of adjustment can last for years.

In a recent column, we addressed the new federal requirement that food companies (beginning in June 2012) adopt written food safety plans, alternatively referred to as Hazard Analysis and Critical Control Point (“HACCP”) plans. While the initiative may appear relatively simple and straightforward, in practice it may prove difficult for FDA to enforce the new requirements both uniformly and fairly. Thus, we wanted to take a moment to highlight some of the momentous challenges associated with the eventual implementation of the FDA’s new food safety rules.

The concept of HACCP was jointly developed in the 1960's by Pillsbury and NASA in a project aimed at keeping astronaut's food pathogen-free. Microbiological testing, they knew, was only effective to a point. So, they collaborated on a program aimed at understanding where and how failures in food safety occur. The result was HACCP; a program designed to seek out and identify the processing points where food safety risks could be reduced to the greatest extent possible. In the 1990s, FDA mandated HAACP for sea food production, and HACCP was eventually required by FSIS in meat and poultry establishments.

The program has been largely successful in the meat industry, and has led to a pronounced reduction in the number of foodborne illnesses and outbreaks. As with any regulatory initiative, however, it requires continuous refinement as science, technology and consumer attitudes mature. In spite of HACCP’s far-reaching success in the meat industry, it is important to note that the meat industry produces a fairly limited set of distinct products. And, all beef slaughter operations, by nature of the processes used, follow relatively similar HACCP programs. The risks are finite, and can be addressed from one plant to another with identical (or at least similar) interventions. Thus, within the meat industry, establishing uniformity in enforcement and compliance, while never easy, has at least proven somewhat manageable.

The FDA on the other hand, is a whole different kettle of fish. Under the new requirements, each and every food processor will have to identify, categorize and then formally address a unique set of hazards. In other words, the HACCP program at a factory which makes frozen waffles is going to be fundamentally different than the one for a processor who makes yogurt, crackers, seasonings or egg salad sandwiches. There are tens of thousands of food processors in the U.S. making hundreds of thousands of products.

So, how will the FDA ultimately approach the development and implementation of an inspection apparatus that deals uniformly and fairly with thousands of companies producing hundreds of thousands of distinct food products? This, of course, is the million (or, perhaps, billion) dollar question. This is also a question which should be flagged and debated today, as opposed to next year when compliance (however that term is ultimately defined by FDA) will be required.

In a perfect world, FDA could simply publish guidance materials outlining a single HAACP methodology (with a single set of compliance standards) that could be applied uniformly to every manufacturing facility and food product. This, however, would prove impossible. As noted, there are simply too many different food companies producing too many dissimilar food products, and there is no such thing as a one-size-fits-all science-based HACCP program.

Additionally, even if a uniform set of compliance benchmarks could be adopted and understood by all, it remains unclear how the FDA would uniformly enforce those standards throughout its many districts. In each of the FDA’s jurisdictional districts, there will inherently be countless different inspectors each sharing different qualifications. Thus, the follow-on dilemma for FDA will be how to ensure that the cookie producer in New York is ultimately being judged by the same standards as the one in California.

That, of course, presumes that the FDA inspectors will be adequately trained in HACCP. Indeed, before the FDA can determine whether any company is in compliance (again, once this term is better defined by the agency), FDA inspectors will need to gain significant expertise in HACCP. They should, ideally, hold a degree in food science, and have a clear understanding of the risks which exist in the specific products they oversee (which, as noted, could exceed thousands if not more). As of today, however, many FDA and other public health inspectors lack the appropriate food science background. Thus, there is and will continue to be a shortfall of the qualified inspectors needed to build an inspection apparatus of the size and scope necessary to visit, even on a rotating basis, each of the food processing plants in the country.

And, that’s just here at home. In today's rapidly globalizing world, many of the food products in our nation’s grocery stores, gas stations, drug stores and specialty shops contain imported ingredients. From salt and pepper to noodles, brownies and whipped cream, the things we consume often contain ingredients from faraway places. It remains to be seen who, if anyone, will oversee these products.

Thus, it stands to reason that the FDA will have to substantially increase the number and qualifications of its inspectors, not only in the United States, but also possibly abroad, to meet the goals of the FSMA. The FDA must also recognize, however, enforcement will be complicated tremendously if the inspectors who are tasked to ensure compliance lack the basic experience and training needed to oversee a science based a system which, while appearing simple on paper, can in practice be extremely complex.

With that said, both FDA and industry have time to address many of these challenges, and I have no doubt they can do so successfully. Companies and business owners, however, need to pitch in as well.

The new legislation presents a unique opportunity for industry to partner with FDA in order to prepare for and streamline the implementation of FSMA. In advance of each pending deadline, FDA will invite industry to comment on its proposed rules and regulations. In turn, offer written suggestions, and ask the FDA to define, as precisely as possible, what its ultimate expectations will be. Companies should take maximum advantage of these opportunities, as it will be their best chance to play a role in developing the rules (and, by extension, the expectations) which will one day govern their food safety programs.

As with any large undertaking, active engagement (as well as preparation and planning) will make all the difference between success and failure. Use the time you have now to prepare for the sweeping changes which will soon be at your doorsteps. Lastly, if you do nothing else, work alongside and communicate with the FDA as these changes are instituted. How, exactly, your food safety plan is ultimately enforced may eventually be up to you.
 

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Just yesterday, FSIS formally published its final determination and request for comments relating to its decision last week to declare non-O157 STECs as adulterants in ground beef and trim products. Since the announcement last week, there has been a great deal of concern within the industry over the scope and breadth of the proposed new regulations.  

Generally, FSIS intends to carry out verification procedures, including sampling and testing to ensure control of both O157:H7 and, now, the six other STECs.

To allow industry time to implement possible changes to food safety systems, however, FSIS will generally not regard products found to have these pathogens as formally "adulterated" until it begins this routine testing. As of right now, FSIS intends to begin a routine sampling program for the non-O157 STECs no later than March 5, 2012.

A significant concern for industry at this early stage is the elapsed time between micro-sampling and results. At this point, FSIS estimates that negative (or presumptive positive) results could be available within 48 hours of sampling. For samples that are initially reactive an additional three to five days may be necessary for a confirmed positive or confirmed negative result.

Fortunately, the antimicrobial interventions used by beef manufacturers to control E. coli O157:H7 are believed to be equally effective in controlling non-O157 STECs. Thus, while it is inviting industry comment, the agency "does not anticipate" at this point that industry will have to incur additional cost by implementing new or different interventions. They do, however, “anticipate that many firms will want to implement their own testing programs and even conduct the same kind of testing that FSIS plans to carry out.”

According to FSIS, establishments that manufacture raw, non-intact beef products (or intact raw beef components of those products) will be expected to evaluate whether non-O157:H7 STECs are a hazard reasonably likely to occur. If a company’s HACCP plan cites O157 as a hazard reasonably likely to occur. If so, those companies will also be expected to reassess their HAACP plans and address the new hazard accordingly; likely by testing for it.

Finally, in the event that FSIS finds a non-O157 STEC in a regulatory sample, it will conduct a for cause food safety assessment (FSA), "as it does currently for E. coli O157:H7-positive [regulatory] samples."

With this as the prelude, FSIS is inviting comments on its proposal from public and industry. Since it currently intends to begin testing for non-O157:H7 STECs as soon as March 2012, however, the agency recommends that any comments be submitted no later than November 1, 2011. Thus, while rules are never really meant to be broken, they are, at least in this case, meant to be critiqued. 

So, while FSIS has indeed created a "new set rules" as they apply to non-O157:H7 STECs, you may be able to influence, at least in part, how those new rules will ultimately be implemented and enforced. 

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After years of deliberation, USDA has formally declared six additional pathogenic E. coli serogroups (O26, O45, O103, O111, O121 and O145) to be adulterants in non-intact raw beef.

From this point forward, any raw ground beef or tenderized steaks found to contain these pathogens will be prohibited from sale to consumers.

While some within the beef industry reacted warmly to the news, others where not so receptive. In a September 13^th, press release, AMI Executive Vice President James H. Hodges criticized the foundation of the new policy:

“This new policy is not supported by science and likely will not benefit public health.  Indeed, in the policy notice USDA acknowledged that ‘we do not know how many illnesses will actually be prevented.  It is not clear whether or not there will be a reduction in the number of illnesses.  It is also challenging to know what the industry cost will be because it is difficult to predict how many establishments will start to test and what the size distribution will be or to what extent industry will take additional measures that will prevent, reduce, or control those hazards, as they do with regard to O157 STEC.”  

Indeed, in many ways, the issue has given way to more questions than answers. Processors, especially small ones, are asking how they will be able to adapt to the likely array of new testing requirements and protocols which may soon be be expected of industry. Moreover, as of today, the time needed to carryout the tests has been causing significant problems for those companies which are already testing.

“It can be a cumbersome process,” Craig Letch, director of quality assurance for Beef Products Inc., told Meatingplace. Letch said that while testing for E. coli O157:H7 can hold up a product shipment for days, there have been times when products being tested for the new strains have been held for even longer, “if in fact you have reactivity.”

Many companies, especially those dealing in fresh products, simply do not have the space or capacity to hold their products for nearly a week before shipment. The added expense of not just testing, but then instituting new programs and holding product for extended periods of time, could significantly and adversely affect both industry and consumers alike.

I have always been the first to commend USDA for demonstrating a real commitment to food safety. In the absence of any real studies supporting this decision, however, the policy appears to have been driven more by sensationalism than by science. 

While it may feel good to declare a bug an adulterant, there is little to show, at this point, that it will have any effect on making our food safer.

I sincerely hope that I am proven wrong.

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Anyone involved in the food industry has now heard about the recent passage of the Food Safety Modernization Act (“FSMA”).

Although the FSMA imposes many new and (some might argue) exotic requirements on industry, the one that will likely have the greatest impact on food companies is the mandate that they “develop and implement written food safety plans.” In turn, many companies are now asking, what does this really mean? Although none of us can be certain until the FDA begins enforcing the new laws (starting in June 2012), we can give you a pretty good sense of what to expect.

Following the passage of the FSMA, and in an attempt to keep things sounding as simple as possible, the FDA announced in its promotional materials that, moving forward, food companies will simply be required to adopt “Food Safety Plans.” But things, of course, are not always as simple as they sound. In regulatory and legal terms, this means that regulated food companies will soon be required to develop and then closely follow the Hazard Analysis and Critical Control Point (“HACCP”) methodology. 

So, what is HACCP? Well, at its most basic level, it’s a system designed to address the food safety hazards we fear most. The HACCP concept was first developed by Pillsbury in the 1960s, as a quality control program to govern the production of food for the United States space program. Under the HACCP methodology, a food processor would first identify the hazards reasonably likely to affect the safety of its food (including the introduction of chemical, physical and microbiological contamination), and then establish various critical control points where interventions could be used to prevent, reduce or control those hazards. Ultimately, HACCP was critically important for NASA as it worked to ensure that the meals its astronauts were taking into space would be as safe (and as free from unwanted contamination) as possible. 

Years later, in the early 1980s, Foster Farms (a California company) was one of the first meat processors to introduce HACCP into its own operations. Thereafter, in 1985, HACCP gained additional notoriety when the National Academy of Science recommended HACCP as a means to modernize the USDA’s meat inspection system. Eventually, in the 1990s, USDA mandated HACCP for all meat and poultry production in the United States. At about the same time, FDA mandated HACCP for all seafood production, and extended these requirements in 2001 (in response to numerous outbreaks involving unpasteurized juices) to the domestic juice industry. And, more recently, recognizing how HACCP has improved the overall safety of these products, FDA successfully petitioned to have the new FSMA extend HACCP to all other segments of the food industry. Thus, with only a few exceptions, the FDA will soon require all food companies regulated by the agency to develop and closely follow their own HACCP plans. 

In turn, according to the FDA, the underlying goal of HACCP is to prevent problems from occurring in the first instance. Although describing the HACCP methodology can be somewhat complex, food companies will generally be required to: (1) formally consider and identify all reasonably foreseeable food safety hazards; (2) develop written plans addressing each of those hazards; and (3) closely follow those plans to reduce or eliminate such hazards to the greatest extent possible.  More specifically, the underlying principles of HACCP will require regulated food companies to do the following:

1. Assess Hazards: Conduct a hazard analysis to identify reasonably foreseeable food safety hazards, and develop reasonably appropriate control measures for each;

2. Determine Critical Control Points: Identify appropriate critical control points (“CCPs”) where a control measure can be applied to prevent or reduce an identified hazard;

3. Establish Critical Limits: Define acceptable and unacceptable science-based limits for all CCPs, and use those limits to ensure the production of a consistently safe product.

4. Establish Monitoring Procedures: Monitor each CCP continuously in order to identify and immediately address any deviations from the critical limits which may occur; 

5. Establish Corrective Actions: Develop procedures to be followed in the event of a deviation, which should include an assessment of the root cause, the disposition of affected product, and a written record of any corrective actions;   

6. Establish Verification Procedures: Test and critique the HACCP plan, once designed (and periodically thereafter), to verify that the HACCP plan is working correctly;

7. Establish a Record Keeping System: Develop a system to maintain and catalog all HACCP documentation for at least 2 years, in such a form that any records can be promptly made available to the FDA if requested by the agency for inspection.

Recognizing this may be a lot to swallow, there are plenty of resources available to help companies develop their own HACCP plans. As a starting point, and although they should never be used as a substitute for a well-designed program which will withstand agency scrutiny in your specific facility, both the FDA and numerous industry associations have published basic guidance materials online (and will likely be publishing additional materials in the months to come).

In addition to these background materials, there are numerous industry consultants and lawyers who will be available to help you develop, refine and critique your HACCP plan. In this regard, all companies should strongly consider obtaining advice from a qualified expert in the field as they work to ensure compliance. This is because a company’s HACCP plan will not only need to be scientifically and legally sound, but the plan itself will, for all practical purposes, become a direct extension of in-plant federal FDA regulation. Put simply, the FDA’s new regulations will not only require that your HACCP plan be adequate, but that it also be followed precisely.

So, what IS a Food Safety Plan?  Technically speaking, it is a comprehensive science-based HACCP plan. In lay terms, however, it’s a proven system designed to address the food safety hazards we fear most.

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The Food Safety Modernization Act (“FSMA”) has now been law for more than six months. In turn, FDA issued a progress report on its implementation efforts since the FSMA was signed into law last January:

Preventive Controls:

In April, almost 500 persons participated in the agency’s public meeting seeking information on preventive controls used by industry to identify and address hazards associated with specific types of food and specific processes. FDA is actively seeking further industry comment (through August 22) on its rulemaking for preventive controls. Please click on the following links to review the docket on preventive controls and submit your comments electronically or via mail.

Imported Foods:

More than 500 persons were given the opportunity in a March public meeting to weigh in on each of the four FSMA import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; Voluntary Qualified Importer Program; and Foreign Supplier Verification Program.

On May 5, 2011 FDA issued an interim final rule requiring that a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

Food Smuggling:

On July 3, 2011 FDA issued a joint anti-smuggling strategy developed with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) to prevent smuggled foods from entering the United States and potentially threatening consumer safety and national security.

Registration Suspension:

Effective July 3, 2011 FDA has the power to suspend the registration of a food facility, thus ceasing operations, if it believes there is a “reasonable probability” that food from the facility could cause harm to humans or animals.

Administrative Detention of Food:

Also on July 3, 2011 the rule on criteria under which FDA may order administrative detention of food product went into effect. FSMA lowered the standard, granting FDA the power to detain food product for up to 30 days if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. Click on the following link to review the Rule on Administrative Detention.

Seafood:

FDA issued an updated guide to the seafood industry on appropriate controls for hazards associated with fish and fishery products. Industry may employ different controls if the alternative controls satisfy the applicable statute and regulations. Click on the following link to view Seafood Hazard and Control Guidance.

Inspections and Compliance:

In June, almost 700 people participated in the agency’s public meeting regarding FDA’s development of guidance and regulations and/or the implementation of: Enforcement Authorities; Frequency and Targeting of Facility Inspections; Manner of Inspection in a Preventive Controls Environment; and Enhancement of the Reportable Food Registry (RFR).

Funding:

FDA’s progress report did not touch on what might be FSMA’s biggest obstacle: funding. The agriculture appropriations bill recently passed by the House of Representatives would decrease funding to the FDA next year by $87 million.

Hopefully, the agency is receiving abundant, constructive advice from industry that will lead to practical regulations which facilities can utilize to improve their food safety, regardless of whether FDA is able to frequently stand over their shoulders and inspect.
 

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Moving forward, the Food Safety Modernization Act (“FSMA”) requires the U.S. Food and Drug Administration (“FDA”) to issue rules governing preventive controls in FDA registered food facilities. In turn, food facilities must develop, no later than June 2012, written Hazard Analysis and Critical Control Point (HACCP) plans which are compliant with those rules.

Under FSMA, HACCP plans must identify all known or reasonably foreseeable hazards that may be associated with a food facility and then spell out the preventive controls which assure that the hazards will be minimized or prevented and food will not be contaminated.

Effective preventive controls yield safer food and are, undoubtedly, one of the top weapons against foodborne illness. Given the incredibly diverse range of food facilities and products which FDA regulates, how can its rule on preventive controls reconcile with the equally diverse range of controls needed by these facilities?

Hopefully, industry input will help. “The preventive-controls requirement of FSMA is one of the most important aspects of this historic law on food safety,” said Michael R. Taylor, deputy FDA commissioner for foods. “It’s imperative that we get information, data and feedback from industry and other stakeholders.”

FDA held a public meeting regarding preventive control rule-making in April (click on the following link to view the public meeting transcript), and is now seeking industry comment in electronic or written form through August 22, 2011. Click on the following link to submit your comments electronically or via mail.

FDA regulated food facilities should take care to review the status of preventive control rule-making, and also provide comments to help, where possible, shape the new regulations.  Click on the following link for updates on the status of FDA preventative control rule-making.
 

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In November 2009, U.S. Rep. Rosa DeLauro, Chairwoman of the House Agriculture-FDA Appropriations Subcommittee, asked the USDA’s Office of Inspector General (“OIG”) to investigate the efficacy of the Food Safety and Inspection Service’s (“FSIS”) N-60 sampling method to test beef trim for E. coli O157:H7.

In response, the OIG spent six months, from January to June 2010, auditing the FSIS’s N-60 program, and then issued the first portion of its findings in March 2011. Click on the following link to view a copy of the “Phase I” report. The detailed, 40-page report concludes that FSIS must thoroughly reevaluate its N-60 sampling program for testing beef trim.

The report demonstrates that an incredible amount of work has been done, and remains to be done, by both the OIG and the FSIS on this issue. The OIG has not yet even performed “Phase II” of its investigation. The bottom line is that FSIS will increase the amount of testing it performs for E. coli O157:H7.

While some positive changes will flow from the OIG investigation (perhaps from the Phase II evaluation of whether plants are following proper protocols for their own sampling and testing), there are valid questions about the investigation’s merit. Should so many more resources be invested in the concept of testing when we can never test to zero? As the prevalence of E. coli O157:H7 in beef continues to decrease, are we just going to continually increase our testing to look for a needle in the haystack that, thankfully, is now rarely present? Can the FSIS rely more heavily on the robust E. coli O157:H7 testing already being done by industry?

Testing is an important part of the validation process, but as OIG concedes, “testing alone cannot suffice to ensure that consumers are safe from a pathogen like E. coli O157:H7.” It is striking that the response to Rep. DeLauro’s request to the OIG regarding N-60 testing was expedited, but the industry’s petition to the FSIS for carcass irradiation has gone unanswered (Despite Safety Benefits, FSIS Delays Approval Of New Food Safety Technology).

Over five years ago, the American Meat Institute (“AMI”) submitted a petition to the FSIS to approve the use of carcass e-beam irradiation technology in meat plants. AMI requested that the petition be granted so that low levels of irradiation could be applied to the surface of chilled beef carcasses as a food safety processing aid. The use of this technology has proven to be an effective measure in reducing the presence of pathogens in raw meat products.

Carcass irradiation is an intervention that could immediately increase the safety of our food. We implore the FSIS to approve carcass irradiation without any further delay.
 

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In January 2000, the U.S. Department of Health and Human Services (“HHS”) published Healthy People 2010, a 10-year agenda for improving our Nation’s health. The agenda included future goals relating to the overall reduction of foodborne illness. Fast forward 10 years, and we find that the agency’s goal regarding E. coli O157:H7 (“E. coli”) was met and actually exceeded. The target for Salmonella, however, was far from the mark.

HHS had hoped that, by 2010, there would be only 1 case of E. coli O157:H7 and 6.8 cases of Salmonella reported per 100,000 people. FoodNet data from 2009 showed the actual number of E. coli illnesses was .9 per 100,000, and Salmonella illnesses was 15.2 per 100,000. The actual number of Salmonella cases in 2009 was more than double the Healthy People 2010 goal.

Industry and government (and the media) have intensely focused on E. coli since 1993. The incredible result of that focus and determination is a 41% decrease of laboratory confirmed E. coli illnesses in the past ten years (per FoodNet). Now that the data on Salmonella is clear, and following directives made by the President’s Food Safety Working Group, the Food Safety and Inspection Service (“FSIS”) and U.S. Food and Drug Administration (“FDA”) have indicated that more of their attention will be turned to Salmonella.

FSIS recently announced the implementation of more aggressive performance standards relating to the prevalence of Salmonella in chicken and turkey products. The new standards, set to take effect in July 2011, are projected by the USDA to reduce the numbers of foodborne illness in the United States by as many as 25,000 within two years.

The new standards reduce the acceptable levels of Salmonella to 7.5 percent in young chickens, which equates to a maximum allowable positive rate of 5 in 51 samples (and a slightly lower 4 in 51 samples for turkeys). The previous standard, in effect since 1996, allowed for a positive rate up to 20 percent.

Last summer, the FDA issued a much stricter food safety rule aimed at decreasing egg-related Salmonella illnesses. Under the new requirements, egg producers whose shell eggs are not processed with a treatment such as pasteurization must adopt new measures to prevent Salmonella contamination, conduct testing in the poultry house, and ensure proper refrigeration during storage and transportation.

The FDA expects the regulation to prevent approximately 79,000 cases of Salmonella each year. The FDA is also counting on new inspection powers and more funding under the Food Safety Modernization Act to factor into the success of the rule.

The HHS has set a more modest target for Salmonella in Healthy People 2020: 11.4 cases per 100,000 people. Hopefully, industry and regulator ingenuity can meet this challenge.

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The U.S. Food and Drug Administration (“FDA”) has released its annual report regarding the first year of operation of the Reportable Food Registry (“RFR”).

The RFR is an internet based portal for Registered Food Facilities to report potential problems with FDA-regulated food and feed products. Facilities that manufacture, process, pack, or hold food or feed must submit a report when there is a reasonable probability that a product will cause serious adverse health consequences to humans or animals.

The RFR was activated in September 2009 in accordance with the FDA Amendments Act of 2007 to: (1) provide a “reliable mechanism to track patterns of adulteration in food;” and (2) “to target [the FDA’s] limited inspection resources to protect the public health.”

Between September 2009 and September 2010, a total of 2,240 reportable food submissions were entered into the RFR. Of these 2,240 entries, 229 were primary reports, 1872 were subsequent reports as a result of a primary report; and 139 were amendments to previously submitted reports.

A primary report is an initial report concerning a reportable food from either industry or public health officials, while a subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted. FDA’s annual report succinctly lays out what contaminants and what types of food comprised the 229 primary reports. The pie graph below illustrates the seven food safety hazards found in the primary reports:

Sixteen (16) primary reports concerned Salmonella in spices and seasonings. The FDA reported that in response to this RFR finding, a national spice trade association is developing guidance to reduce the risk of pathogen contamination in spices. FDA also reported a second industry change driven by the RFR: one of the nation’s largest baking industry trade associations is enhancing its industry guidance on preventing unintended allergens from being introduced into bakery products.

Passage of the new Food Safety Modernization Act (“FSMA”) has also placed many new responsibilities on the FDA’s shoulders. The FSMA has increased the frequency of FDA inspections of all facilities, so whatever inspection capability is left over must be devoted to the most high-risk commodities.

Of the 229 primary reports, 226 were submitted by industry and just 3 were entered by federal and state regulatory officials.

It should be noted that 1,000 of the 1,872 subsequent reports were related to the massive recall of Hydrolyzed Vegetable Protein (“HVP”) in March 2010 due to Salmonella concerns. The manufacturer of the HVP notified its many customers of the situation and each customer then submitted a subsequent report.

The FDA annual report regarding the RFR stated that no illnesses related to the HVP recall were reported. Likewise, the report stated that no illnesses related to a separate recall for an undeclared allergen were reported. To date, it would appear that no serious health problems were reported in connection with any of the RFR reports.

The RFR also tracks data on reports concerning foods and ingredients from international sources. This first year showed that 53 of the 229 primary reports were caused by foods or ingredients from foreign sources, coming from at least 21 different countries. China caused 13 problems, the most, while Mexico took second place with 5 issues. Click on the following link to view a copy of the the FDA’s most recent RFR ANNUAL REPORT.

Moving forward, the RFR will continue to play a significant role in food safety regulation. Thus, contact our firm for additional information if you have any questions regarding how the RFR works, or the circumstances under which your own company may someday need to submit a report.
 

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In recent years, delis have greatly expanded their product portfolio, catering to a growing need for more ready-to-eat items in a faster paced world.

For these reasons, food safety in delis has never been more important.  One of the most critical control points for food safety in delis (as well as restaurants and other foodservice establishments) is the slicer, which is commonly used to slice meats, cheeses and produce.

Unfortunately, deli slicers can sometimes be difficult to clean. According to the U.S. Food and Drug Administration (“FDA”) Food Code, deli slicers should be disassembled, cleaned and sanitized per the manufacturer’s instructions at least once every four hours to prevent the growth of disease-causing bacteria.

This, of course, can create numerous challenges for food companies. First, the task may be difficult to accomplish in a busy deli or restaurant which relies on slicers throughout the day to meet unpredictable customer demand. Second, slicers may become more difficult to properly clean over time.

Seals and gaskets within a typical deli slicer may become worn or degraded as a result of heavy use and cleaning. In some instances, this can create spaces that trap debris and moisture, and these spaces may not be able to be adequately cleaned under normal conditions. Thus, slicers should be frequently examined by operators for worn or broken parts and seals, and regularly serviced by manufacturers.

Large scale foodborne disease outbreaks allegedly linked to deli slicers have recently prompted a national study on slicer food safety. In one outbreak, seventy-two patrons of a restaurant became ill with Salmonella over a three-month span. The same strain of Salmonella which sickened the patrons was found on the restaurant’s slicer.

Currently, the Rhode Island Department of Health is leading a nation-wide study regarding the extent to which inadequately cleaned or poorly designed slicers are causing foodborne illness. The department’s investigation has confirmed that slicers are not always being properly sanitized every four hours. Additionally, the department identified three brands of slicers with certain design limitations that can inhibit proper cleaning.

Hopefully, a new initiative by the FDA will bring a renewed effort on this food safety issue. The FDA developed a poster and flyer designed to raise awareness of the sanitation concerns with slicers. The poster, which explains the importance of proper slicer maintenance and highlights examples of hard-to-clean problem areas, can be tacked up right beside a slicer.

The flyer provides tips for food safety professionals inspecting deli slicers. Click on the following link for the FDA’s press release, or to download or order the poster and flyer at no charge.
 

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The FDA Food Safety Modernization Act (“FSMA”) is now law.

The FSMA is the first major amendment in almost 75 years to the food safety regulations of the Federal Food, Drug and Cosmetic Act.

Since FDA regulated manufacturers may feel overwhelmed by the 89 page act, let’s take a deep breath and walk through some of the FSMA’s key provisions -- and when they go into effect.

The FSMA governs food products regulated by the FDA; it does not apply to meat, poultry or egg products regulated by the USDA. The new law grants additional power to, and also places additional requirements on, the FDA:

• Inspections: FDA must inspect high-risk food processing facilities at least once in the next five years, and once every three years after that. Low-risk facilities must be inspected at least once every seven years. [Effective immediately].

• Detentions: FDA has the authority to detain food product if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. This is a lower standard than under the FD&C Act. [Effective June 2011].

• Suspensions: FDA may now suspend facility operations if it believes there is a reasonable probability that food from the facility could cause harm to humans or animals. [Effective June 2011 or upon FDA’s issuance of regulation to implement].

• Recalls: FDA now has the authority to force a food recall. [Effective immediately].

• Performance Standards: FDA must evaluate relevant health data every two years to determine the most significant foodborne contaminants and then issue guidance documents or regulations setting contaminant-specific performance standards. [Effective date undetermined, implementation requires FDA rulemaking].

• Imports: FDA may require importers to provide a safety certification from an accredited third-party auditor as a condition of granting admission. [Effective immediately.]

Under the FSMA, food companies will also now have to develop and implement Hazard Analysis and Critical Control Point (HACCP) plans. Although this may initially be a burdensome task, companies implementing strong HACCP protocols will, most importantly, produce safer food. And further, companies executing good HACCP controls may see strong inspection results and avoid detentions, suspensions and recalls.

The written HACCP plan must include five elements:

• Hazard Analysis: Food companies must identify and evaluate all known or reasonably foreseeable hazards that may be associated with the facility (such as biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives, and hazards that may be intentionally introduced) and prepare a written hazard analysis.

• Preventative Controls: Food companies must identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the food processed by the facility will not be adulterated or misbranded.

• Monitoring: Food companies must monitor the effectiveness of the facility’s preventive controls.

• Corrective Actions: Food companies must establish procedures to ensure that, if preventive controls are not properly implemented or are found to be ineffective: (a) appropriate action is taken to reduce the likelihood of a recurrence (b) all affected food is evaluated for safety (c) all affected food is prevented from entering commerce if the company cannot ensure it is not adulterated.

• Verification: Food companies must verify that the facility’s preventive controls are adequate to control the hazards identified in the hazard analysis, that monitoring is being conducted, that appropriate decisions about corrective actions are being made, and that there is periodic reanalysis of the HACCP plan.

In addition, food companies must maintain, for not less than 2 years, records documenting the monitoring of the preventive controls, instances of nonconformance material to food safety, the results of testing and other means of verification, corrective actions, and the efficacy of preventive controls and corrective actions. These records must be made available to FDA upon request.

Food companies, other than small businesses, must have their HACCP protocols in place by June 2012.

Other notable requirements placed on food companies by the FSMA include:

• Registration:  Food companies must register with the FDA biennially, between October 1 and December 31 of each even-numbered year. [Effective immediately.]

• Imports: Food importers must perform risk based foreign supplier verification activities to verify that the food imported is not adulterated. [Effective January 2013.]

• Additional Future Performance Standards: Food companies must engage a Federal laboratory or other accredited laboratory to perform analyses of food products and submit the results directly to the FDA. [Effective January 2013.]

While many of the FSMA’s key provisions do not take effect for a year or more, it is critical that food companies begin planning for these changes now. If your company already operates under the HACCP methodology, now is the time to re-evaluate your plan and verify it will comply with the FSMA standards. If your company has not yet implemented a HACCP system, now more than ever is the time to enhance your food safety system with formal recognition and monitoring of potential hazards.

Please contact us with any questions regarding these significant changes in food safety law.

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After weeks of haggling, Congress has now passed the Food Safety Modernization Act.

A few weeks ago, we all thought the new law (passed in its then-current form) was headed for the President’s desk. We soon learned, however, that the legislation which had passed was, in fact, technically unconstitutional. Because the bill inadvertently contained certain revenue provisions, it should have originated in the House of Representatives, not the Senate. These issues have been resolved, Congress approved the legislation shortly before Christmas, and the bill is now heading to the White House.

Click on the following link to view the text of the bill:  Food Safety Modernization Act.

The Food Safety Modernization Act (“FSMA”) will govern food processors and products regulated by the U.S. Food and Drug Administration ("FDA"). The new act increases federal inspections, requires virtually all regulated food companies (with very few exceptions) to adopt Hazard Analysis and Critical Control Point (“HACCP”) plans, and grants the FDA mandatory recall authority. The new legislation also proposes to enhance our nation’s foodborne illness surveillance and tracking capabilities.

The biggest change for food companies, however, will be the new HACCP requirements. Under the new law, food companies will be required to: (1) formally consider and identify all potential food safety hazards associated with their products and operations; (2) develop written plans to respond to each of those hazards; and (3) to closely follow those plans to reduce or eliminate such hazards to the greatest extent possible.

Not only will the HACCP plans developed by these companies need to be legally adequate (something which will likely prove extremely difficult to define and enforce on a consistent basis), the resulting plans themselves will also, for all practical purposes, become an extension of in-plant federal regulation.Thus, as companies develop and implement their own individualized HACCP plans, they should also recognize that they will be expected by FDA to follow them precisely. Click on the following link to see a more in-depth discussion of the new law and possible ramifications: Jolley: Bill Marler & Shawn Stevens Talk About The New Food Safety Modernization Act .

Although not all provisions of the new legislation will go into effect immediately, food companies should begin planning for the changes that are likely to occur.

There have also been some recent notable developments relating to produce. Beyond the FSMA itself, the FDA has also announced the creation of a new organization that will likely impact produce growers and packers in the near future. The Produce Safety Alliance is a public-private organization funded by the FDA and United States Department of Agriculture’s Agricultural Marketing Service.

The three-year, $1.15 million alliance aims to help produce growers and packers access food safety educational and training materials by:

• Developing a program on Good Agriculture Practices (GAPs) and co-management;

• Creating an information bank of up-to-date scientific and technical information related to on-farm and packinghouse produce safety and environmental co-management;

• Establishing a network of educational collaborators;

• Conducting an assessment of existing educational outreach tools to identify knowledge gaps and to provide for continuous updating; and

• Launching a website to make the alliance’s work and information readily accessible.

The alliance was also created to assist growers and packers with a new produce safety regulation that the FDA expects to propose in 2011, which will focus on production, harvesting and packing. FDA Deputy Commissioner for Foods Michael Taylor said “As we traveled around the country listening to growers and packers and soliciting their comments even before we propose a produce safety rule, we have committed ourselves to just this kind of collaborative effort.” As always, share your experiences and views with FDA at every opportunity afforded to you.

Put simply, the Produce Safety Alliance aspires to create a one stop shop for the food safety needs of produce growers and packers. The California Leafy Greens Marketing Agreement (LGMA) endorses the alliance and hopes to participate on the alliance’s steering committee. Jamie Strachan, chairman of the LGMA’s advisory board said “The objectives of this new initiative are in line with those of the LGMA.” The alliance’s steering committee will be comprised of government officials as well as industry leaders, including growers and packers and produce trade organizations.

In any event, one question often asked is whether the FSMA will make our food safer. I think the answer is yes. Regardless of where you stand politically on the issue, I think we could all agree that requiring all food companies to develop and follow HACCP plans will have a net positive effect on food safety. Moreover, under the new laws, it should become easier for food safety lawyers like us to defend food companies faced with a foodborne illness claim or caught in an outbreak scenario.

In response to the new rules and regulations now on the horizon, most food companies will be working to enhance their food safety programs. Understanding that, despite our best efforts, mistakes can and will occur, we would much rather be defending food companies with robust food safety programs than defending those companies with none at all.
 

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The Food Safety and Inspection Service (“FSIS”) revealed its vision for 2011 at the North American Meat Processors Association’s Annual Outlook Conference. Briefly, Dr. Dan Engeljohn, FSIS’s chief policy writer, touched on the following:

• Salmonella will receive more attention in 2011;
• A HACCP Validation Guidance Draft will be issued in early 2011;
• New regulations for labeling non-intact product may be published in late 2011;
• FSIS will respond to the industry’s petition for carcass irradiation “fairly quickly” (the petition has been pending for five years);
• FSIS will focus more on pre-harvest and carcass interventions for beef in 2011.

With regard to the last point, Dr. Engeljohn said that the agency is developing a draft protocol to study beef carcass contamination levels, with the anticipation it will lead to better controls immediately after hide removal. In conjunction with the carcass study, the FSIS will also conduct tests on cattle and water in holding pens. Dr. Engeljohn said pork, poultry and veal slaughter facilities should expect a similar approach from FSIS.

Food manufacturer Cargill has already placed incredible emphasis on preventing contamination at its root. The company, along with Epitopix and the National Cattleman’s Beef Association, developed a cattle vaccine project aimed at reducing E. coli O157:H7 in cattle before they reach the processing plant. On Monday, Cargill announced encouraging preliminary results from its first vaccine trial.

The first trial, at a cost of $1 million, involved 85,000 head of beef cattle from 10 feedlots. The vaccinated cattle, harvested by Cargill from May through August, had a favorable immune system response to the vaccine with no adverse reaction. There was enough promising evidence in the first trial that the company will conduct a second trial in summer 2011.

Dan Schaefer, Cargill assistant vice president for beef research and development stated “While additional research is required to better understand vaccine's potential value in controlling E. coli O157:H7 from farm and feedlot to consumers, we're committed to that pursuit. We continuously strive to provide the safest food possible, every serving, every time.”

We are certainly hopeful that the continued endeavors of government and industry alike will yield safer food in 2011 and beyond.
 

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The Food Safety and Inspection Service (FSIS) may be one step closer to taking a substantive stance regarding the non-O157 STEC issue. Recent statements made by the FSIS describe the agency’s progress, and hint at additional regulation.

In October 2009, Bill Marler (a national plaintiffs’ food lawyer) submitted an interpretive rule petition to the FSIS requesting that all non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) be declared adulterants in ground beef. In response to the petition, FSIS stated that when it had an appropriate laboratory method for conducting regulatory sampling for non-O157 STECs, and had developed a plan for how it intended to address the issue, it would make the plan available to the public for comment and would, at the same time, issue a final response to the petition.

Two months ago, Dr. Elisabeth Hagen, Under Secretary for Food Safety, touched on the non-O157 STEC issue at the 2010 National Food Policy Conference and in a statement to the New York Times. Dr. Hagen said that FSIS policies “need to evolve to address a broader range of pathogens, beyond E. coli O157:H7.” She queried how we best protect consumers from pathogens that are not addressed by current policies.

A few weeks ago at the North American Meat Processors (NAMP) annual conference, Dr. Dan Engeljohn revealed that FSIS is “very close to having a [test] methodology for all six” non-O157 STECs. Dr. Engeljohn is the FSIS’s chief policy writer. He reiterated the steps which FSIS will take following completion of the test methodology – a Federal Register notice will outline an enforcement strategy, followed by public meetings and comment, and the issuance of guidance.

While FSIS action is on the horizon, we of course urge the agency to consider carefully the American Meat Institute’s recommendations on non-O157 STECs, summarized as follows:

1. Focus on Prevention
2. Conduct a Comprehensive Public Health Risk Assessment
3. Validate Analytical Laboratory Test Methods
4. Conduct a Baseline Survey of Non-O157:H7 STECs on Beef Products
5. Measure Progress Based on the Public Health Outcome
6. Expedite Approval of New Microbial Interventions
7. Determine Impact on International Trade
8. Provide an Open and Transparent Public Policy Process

A focus on prevention should remain the number one priority. The AMI said it well: Making a pathogen illegal through a policy change will not prevent this pathogen from occurring. Making non-O157:H7 STECs illegal could also divert scarce resources away from enhancing food safety prevention efforts. Click on the following link to view the AMI’s Position on non-O157:H7 STECs.

As noted, a rush to implement test and hold programs for non-O157 STECs could potentially distract from research into even better interventions that prevent O157 and non-O157 contamination alike. The industry’s resistance to additional testing, however, is poorly perceived by consumers because the general public fails to realize the incredible shortcomings of testing. Safer food flows from preventing contamination in the first instance, rather than searching for a needle in a haystack.

And, lest consumers believe that industry is only concerned about the bottom line, I will take this opportunity to commend our food manufacturers on the incredible effort and investment which has greatly improved food safety in the past 15 years. Dr. Engeljohn specifically applauded the beef industry at the NAMP conference. The AMI Foundation alone has millions of dollars in grants towards developing new food safety technologies, and major industry manufacturers have spent billions on food safety improvements.

Hopefully, FSIS respectfully considers the industry’s perspective on non-O157 STECs. We, of course, will continue to follow this issue closely.

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The FDA’s Reportable Food Registry (“RFR”) has now been up and running for a full year.  So, has the RFR been successful?

As we discussed previously, the RFR is an internet based portal through which food manufacturers must notify the FDA of food products that have a “reasonable probability” of causing health problems or death in humans or animals. The RFR applies to any food product regulated by the FDA, with the exception of infant formula and dietary supplements.

This summer, the FDA issued a report on the RFR’s first seven months of operation, September 2009 through March 2010. Click on the following link to view a copy of the THE 2009 - 2010 FDA RFR REPORT.

During the first seven months, food companies submitted 125 “primary reports” through the RFR. A primary report is an initial report concerning a reportable food from either industry or public health officials, such as federal, state, or local regulators. Of those 125 primary reports, 122 were from industry, and 3 were from regulatory officials.

Also during that initial period, 1,638 “subsequent reports” were submitted as a result of a primary report. A subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted.

The FDA classified the 125 primary reports into seven food safety hazard categories, as illustrated in the pie graph below:

Percent Distribution of 125 Primary RFR Entries by Food Safety Hazard

Because this initial reporting period was so brief, the FDA wisely cautions that inferences cannot be drawn from this data. Nevertheless, the figures are still interesting.

More meaningful, however, is that of the 125 reports, only one caused a health problem – “an allergic-type reaction” in four family members. The FDA pointed out that all the reports had the potential to bring harm. However you want to interpret the fact that there was only a single health problem, it cannot be lost among the other numbers. Perhaps it highlights how the RFR brings an abundance of caution that will only make our food supply even safer.

And a meaningful statement was made by the FDA’s Deputy Commissioner for Foods, Michael Taylor. When asked how industry reacted to the RFR, Taylor said “The industry is taking it very seriously. They know it is a legal duty.” We are in a period of consumer distrust. I would like to share with consumers that not only does industry take food safety regulation seriously, I have personally experienced food manufacturers setting their safety standards above and beyond their legal obligation. Although recent media may suggest otherwise, our food manufacturers, with the exception of a few, care deeply about safety.

After just one year, it is too soon to determine whether the RFR will meet its goals of tracking patterns of adulteration and targeting the FDA’s limited inspection resources. The FDA has labelled the RFR’s first seven months “a success story.” It was not a perfect first year – the electronic submission process was already overhauled once; and questions still remain – how many of the potentially hazardous situations would have been reported under regulation in place prior to the RFR?

In any event, we will continue, of course, to answer your questions about RFR compliance and monitor new RFR developments.

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The FDA's Reportable Food Registry (“RFR”) first went into effect in September 2009. Since then, we have been watching closely the application and enforcement of the RFR.

At its core, the RFR is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).

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How clean is your kitchen?

Probably not as sanitary as you think.

A recent study completed by the Los Angeles County Department of Public Health (“LACDPH”) found that only about 61% of home kitchens would receive an “A” or “B” grade if inspected like a restaurant, and at least 14% would flunk.

To put this in perspective, 98% of L.A. County restaurants received an A or B following inspections between 2006 and 2008, and any restaurants that failed were subject to closure.

There is an interesting background leading up to this study. If you have ever been to an L.A. County restaurant, then you have probably noticed a placard posted by the door with a fairly large A or B or crimson C. Beginning in 1998, L.A. County restaurants were required to display their health inspection grade to patrons. The result of this disclosure? By the end of 1998, the number of hospitalizations for food-borne illness was down by 13% in L.A. County.

The LACDPH enhanced these food safety efforts by introducing the Home Kitchen Self-Inspection Program in 2006 to encourage food safety practices in the home.

The program included an online Food Safety Quiz comprised of 57 questions developed around the USDA food safety principles of clean, separate, cook and chill. The quiz asked about food handling and preparation practices at home, but the questions were similar to the standards used to evaluate restaurants.

Approximately 13,000 adults voluntarily completed the quiz between 2006 and 2008; 34% received an A, 27% a B, 25% a C, and 14% failed. Thus, about one in seven homes deserved an “F” placard placed on their front door.

Granted, this study has some limitations. The quiz was only available online and in English. And obviously, the letter grades are based on respondent self-reports and not actual physical inspections of the home kitchens.

However, one such limitation makes the results even more frightening. People who are more interested in, and possibly more knowledgeable about, food safety were more likely to have taken the quiz. Letter grades aside,

• 64% of quiz respondents admitted that when cooking big portions of food to serve later, they did not rapidly cool and store it in a refrigerator;

• 36% of respondents did not have a properly working thermometer in their refrigerator; and

• 33% of respondents did not store raw meat below all other foods in the refrigerator.

Studies continue to evidence there is much more work to be done in educating our consumers. This study referenced how web-based learning tools (i.e. Meat Safety, Meat Matters Info, FSIS) are becoming ever more important in education.

In any event, I suppose, it’s fitting that the research was released during National Food Safety Education Month. Thus, moving forward, let's work to heighten awareness of food safety practices and help make not only the places we produce food, but also the places we prepare it, more sanitary and safe.

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Eggs have been taking a lot of heat lately. The question, of course, is whether it could have been avoided.

Reviewing the most recent FSIS New Technology Information Table, I discovered that a number of the new additions pertain to egg products. And, in light of the recent developments (and scrutiny) involving eggs, there can be no doubt Professor Kevin Keener, of Purdue University, similarly hopes to see his own rapid egg cooling innovation embraced by regulators and industry soon.

Professor Keener has developed a process to quickly cool eggs to 45° (which significantly limits the ability of Salmonella to grow) after laying and processing. This is quite significant in light of the FDA research which Professor Keener cites: studies from the FDA show that if eggs were cooled and stored at 45 degrees or less within 12 hours of laying, there would be an estimated 78 percent fewer Salmonella illnesses from eggs in the United States each year.

The system involves placing eggs in a chamber with carbon dioxide gas at about minus 110 degrees. The cold gas circulates around the eggs and forms a thin layer of ice on the inside of the shell. The ice layer then melts and quickly lowers the egg’s temperature.

Not only does the cooling process have the potential to reduce food-borne illness, it is projected to increase egg shelf life by about four weeks. An extended shelf life also creates the potential opportunity for eggs to be exported. Professor Keener believes the technology can be easily integrated into large scale production without slowing operations, costing between two and five cents per dozen eggs.

The egg cooling technology thus far seems to be a winning proposition. Nevertheless, as scientists and industry continue to research and cultivate the best food safety defences, always remember that raw eggs must be properly handled and cooked.

And if you have not yet read my latest post at Meatingplace – Legally Speaking, please check it out: Salmonella: Surveying the science and sensationalism.

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The “E. coli Traceability and Eradication Act” was introduced by Rep. Rosa DeLauro (D-CT) on July 29. The bill seeks to amend the Federal Meat Inspection Act (“FMIA”) on two major fronts. First, it mandates testing beef for all Shiga toxin-producing E. coli strains, not just E. coli O157:H7. Second, it prescribes extra testing and additional reporting requirements.

The bill, if passed, would require boneless beef manufacturing trimmings and other raw ground beef components to be tested for “Shiga toxin-producing E. coli.” As we previously reported, there is and has been a corresponding push to label non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) as adulterants under the FMIA.

In response to these efforts, however, the FSIS previously announced it could not reach a decision regarding the validity of branding non-O157 STECs as adulterants “until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.” Indeed, even if this bill were to advance, according to the American Meat Institute (“AMI”), there is no test currently available to easily detect the other six non-O157 STEC strains.

In any event, DeLauro’s act calls upon beef slaughterhouses, processing establishments, and grinding facilities to test for and report on the presence of Shiga toxin-producing E. coli at the following points:

• One test at the slaughterhouse or processing establishment at which source trim was produced, and one test of the source trim or bench trim at the receiving facility prior to combining with other lots from different sources.

• If the source trim and grinding occurs at the same facility, one test of the source trim and one test of the final ground product.

The bill does not specify the specific sampling or testing procedures that should be used, but directs the Secretary of Agriculture to develop standards that “enable rapid tracing to the source of contamination.” In turn, the bill would require manufacturers to report any positive or presumptive positive results directly to the Secretary of Agriculture through electronic means within 24 hours after receipt of the results. USDA would then be required to carry out an investigation to identify the original source of the contamination.

In its current form, the bill would also require the USDA, following a positive test result, to conduct supplementary sampling at the establishment and its suppliers for 15 days. In turn, a processor would be listed on the USDA’s website as a “habitual violator” if it received positive results for 3 consecutive days or on more than 10 instances per year.

Given the difficult scientific issues associated with non-O157:H7 STECs (and limitations in testing for any pathogen), and Congress’ current focus on the FDA’s Food Safety Enforcement Act, we think it is unlikely DeLauro’s proposed legislation will pass anytime soon.

With that said, however, the bill has been referred to the Committee on Agriculture, and we of course we will continue to monitor its status.

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On March 14, 2009, President Obama announced the creation of the Food Safety Working Group. The group is currently chaired by Secretary of Health and Human Services Kathleen Sebelius and Secretary of Agriculture Tom Vilsack.

Appearing after the PCA peanut butter outbreak and recall, the Working Group was formed in response to an increasing number of foodborne illness outbreaks in recent years, and was tasked with the responsibility of recommending changes to food safety regulations, fostering better coordination between federal agencies, and ensuring the enhanced enforcement of numerous food safety laws.

In May 2009, the Working Group launched its website (foodsafetyworkinggroup.gov) and held a public “listening day” to solicit input from federal and state health officials, food industry, consumers and others. Then, four months following its creation, the Working Group announced its three core principles: (1) working to prevent harm to consumers as a first priority; (2) recognizing that effective food safety inspections and enforcement depend upon good data and analysis; (3) committing to quickly identify and stop foodborne illness outbreaks.

To facilitate these goals, the Working has Group assisted, in varying degrees, with the development of numerous food safety issues in the past year. Below are just a few of the initiatives recently encouraged and embraced by the group:

• FDA’s new rules to combat Salmonella contamination in eggs.

• FDA request for comments on proposed guidance to reduce microbial contamination of tomatoes, melons and leafy greens.

• USDA's new initiatives aimed at testing bench trim for E. coli O157:H7 and the issuance of draft guidelines on methods for controlling E. coli O157:H7 on the farm.

• The enhancement of www.FoodSafety.gov and content for consumers.

• The opening of the Commercial Targeting and Analysis Center to better ensure the safety of imported foods.

• FDA’s activation of the Reportable Food Registry designed to more quickly identify and track adulterated food products.

• The decisions by FSIS, FDA, and CDC to host joint food safety meetings for input and collaboration on performance measures for food safety.

• The recent decisions by USDA and FDA to conduct additional public meetings regarding product tracing and tracing source materials for E. coli O157:H7 in beef.

These, of course, represent many significant food safety initiatives made possible by substantial governmental and industry collaboration.  So, although the President announced during the creation of the Working Group that “[t]here are certain things [such as ensuring safe food] that only a government can do,"  we would simply note that his statements only paint a partial picture.

Let there be no mistake, Americans do enjoy one of the safest food supplies in the world in part because of continued governmental oversight. But, it is also important to note that American consumers enjoy one of the safest food supplies in the world in a much larger part because of the efforts of the hard-working Americans who actually feed our families. Thus, while government can regulate industry, only industry and its individual members can safety and successfully feed a nation.

So, is the Working Group still working? Of course. But, let us not forget that so are you. Thus, once again, we would like to say "thank you" to all those who work tirelessly, each and every day, to provide safe food for each of us and our families.

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Over the years, I have sampled numerous street food offerings in various cities throughout the U.S. More recently, I have been intrigued by news that certain street foods are both “going gourmet” and growing in popularity.

A few weeks ago, the Chicago Tribune reported on a new movement (spearheaded by gourmet chef Matt Maroni) to greatly expand Chicago’s street food scene (“Chef hopes to change Chicago laws barring gourmet food trucks”).

Unlike many other major cities, Chicago’s ordinances currently permit only pre-prepared and packaged foods to be sold on the street (i.e. hot dogs and popcorn). This is because there can be numerous potential hazards associated with the preparation of foods in mobile food trucks or stands. These include:

• If a food truck or stand is not parked close enough to a bathroom with a hand washing station, the food preparers could themselves contaminate food;

• If the food truck or stand runs low or runs out of potable water (which the truck itself must store in a tank), hands, utensils, equipment and food preparation areas may not be properly washed and sanitized;

• There is the potential for the truck’s power source to inadequately maintain hot and cold temperatures (especially during the heat of summer); and

• There is the potential for cross-contamination between foods such as raw meat and produce due to the limited storage and preparation space.

Recognizing the growing public interest in gourmet street food, however, chef Maroni is hoping to amend the regulations to allow preparation of fresh food made-to-order in a mobile food truck (i.e. flatbread stuffed with braised lamb, marinated tomatoes and a curry tzatziki).

In the amended ordinance he has proposed, Maroni does tackle the potential food safety concerns. And Elizabeth Gomez, director of outreach for Chicago alderman Scott Waguespack, a proponent of the ordinance, said “[w]e are taking our time to make sure that we are addressing public health and safety concerns [and] to ensure that we create an ordinance that will be successful in Chicago." Better technology, as well as commitment to food safety, can also reduce the risks in mobile food trucks. New state-of-the-art food trucks were showcased at the National Restaurant Association’s recent show in Chicago.

So, while we absolutely need to ensure that food (wherever prepared) is prepared safely, I will be watching the new ordinances with curiosity. And, chef Maroni’s braised lamb sure sounds good…

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Since its launch in September 2009, we've been watching closely the application and enforcement of the FDA's Reportable Food Registry (“RFR”).

According to the FDA, the purpose of the RFR is to provide a “reliable mechanism to track patterns of adulteration,” and “to target the agency's limited inspection resources where they're needed most.”

The RFR, at its core, is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).  They're a good read.

Ultimately, sharing helpful perspective and feedback with FDA today could help mitigate downrange confusion and, perhaps, even save your company from appearing in the RFR in the future.

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In late 2008, the FSIS announced that it intended to issue a Federal Register Notice to better explain the validation requirements under its HACCP regulations.

The Agency deemed this clarification necessary because of the “widespread lack of understanding of validation that FSIS has found among establishments, whether large or small HACCP in size or high or low in production volume, and because of the food safety problems that have occurred as a result.”

Unfortunately, the FSIS’s attempt to clarify has created some confusion and much concern. In the past year and a half, the meat industry and its trade associations have given considerable feedback to the Agency regarding validation. Even before the FSIS even issued its preliminary “Draft Guidance for HACCP System Validation” in March 2010, nine trade associations banded together to submit their comments to FSIS on the issue. Since opening the period for public feedback, FSIS has received almost 2,000 comments.

The thrust of the confusion and concern lies with the FSIS’s expectations for microbiological testing under the guidelines. Currently, the guidelines state that “establishments would need to provide support in instances where they believe microbiological testing data is not needed to demonstrate the effectiveness of the HACCP system in controlling biological food safety hazards.” Although the Agency has explained that the guidelines will not impose new microbiological testing requirements on establishments, there is distrust on the issue, particularly by small processors.

Some confusion has already been dispelled through the comment process, however, which highlights the importance of all processors – large and small – being well versed in the draft guidelines and the changes which need to be incorporated. Following an initial review of comments, the FSIS released a Fact Sheet addressing some concerns. The FSIS Fact Sheet confirmed that, among other things, no microbiological testing would be required for "well-established processes", and that establishments would only need to validate one plan per HACCP category.

The final day to submit comments on the preliminary draft guidance is Saturday, June 19, 2010. The Agency plans to complete a final review of the comments on the preliminary draft guidance and then issue an updated draft document in July 2010 for a second round of comments. The FSIS will also hold two public meetings regarding the updated draft.

Hopefully, the FSIS’s willingness to go through a lengthy drafting and comment process will result in true clarification and, ultimately, fewer of the food safety confusion which spurred the Agency to reevaluate its position on validation.

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Following the 1993 Jack in the Box outbreak, the Food Safety Inspection Service (“FSIS”) issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. Since this announcement, and as things are currently postured, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.

On May 27, 2010, however, Senator Kirsten Gillibrand (D-N.Y.) proposed new legislation aimed a classifying six additional strains of E. coli as adulterants under the Federal Meat Inspection Act (“FMIA”). Although the text of the proposed bill (S.3435) is not yet available, Sen. Gillibrand announced that, among other things, the legislation would:

• Define “E. Coli” to includ all “enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of Escherichia coli (E. coli)”;
• Specifically include as adulterants the following seven E. coli strains: O157: H7, 026, 045, 0103, 011, 0121, 0145; and
• Require the USDA and beef manufacturers to test product for all seven strains, and dispose of product in which any of the strains are found.

This bill comes on the heels of the Senator’s April 22, 2010 letter to USDA Secretary Tom Vilsack urging the USDA to begin testing for and regulating the additional E. coli strains. And, as we reported previously, Bill Marler (a national plaintiffs’ food lawyer) also petitioned FSIS in October 2009 for an interpretive rule declaring all non-O157 STECs to be adulterants in ground beef.

The FSIS has since announced, however, that it could not “reach a decision about the substance of the petition until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.”

At a 2007 meeting regarding non-O157 STECs, the FSIS noted that since 1990 there were only an handful outbreaks associated with non-O157 STECs in the United States, and none of them were associated with ground beef. This fact, coupled with a lack of data regarding the prevalence of non-O157 STECs in beef products, has prompted the FSIS to examine the feasibility of more thorough research and testing prior to adopting the significant policy changes sought by Mr. Marler and Sen. Gillibrand.

Additionally, at least some questions still remain about the virulence of non-O157 STECs that may in rare instances find their way into beef products. Not all of the strains, even when present in beef (as opposed to other food products), may be able to produce the specific toxins or combinations of toxins necessary to cause the severity of illness sometimes associated with E. coli O157:H7. Here too, knowledgeable experts concede that more research is likely needed.

Finally, according to the American Meat Institute (“AMI”), there is no test currently available to easily detect the six strains included in the bill. Thus, in addition to needing additional research to quantify the prevalence and virulence of these additional strains in beef, additional efforts would likely be needed to ensure not only that an effective test is readily available, but that the test could be easily obtained and quickly administered.

Even with this said, however, experts at USDA have already confirmed that existing food safety interventions already in place work equally well to combat both O157 and non-O157 STECS. And, AMI recently echoed these comments, noting further that, because “food safety resources in the private sector and the public sector are not infinite, it's important to invest in [new] technologies that will provide meaningful food safety benefits." Thus, whether such resources should ultimately be devoted toward the development and implementation of additional interventions to actually combat pathogens, or whether government and industry should instead invest in “additional testing,” will likely depend upon the results and findings of future research.

Sen. Gillibrand is also sponsoring two other pieces of legislation related to food safety. She authored the E. Coli Eradication Act of 2009 (S.2792), which would require additional tests for E. coli O157:H7 in beef facilities, and is also a co-sponsor of the FDA Food Safety Modernization Act, which will likely pass later this year.

Sen. Gillibrand is a member of the Senate Agriculture Committee. She was appointed to the U.S. Senate in January 2009 to fill Secretary of State Hillary Clinton's seat and is a candidate for the seat in the upcoming November 2010 election.

We will, of course, continue to monitor the non-O157 STEC issue, as well as other pending food safety legislation, and will keep you apprised of any new developments.

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Agriculture Secretary Tom Vilsack has announced that the USDA will be issuing new performance standards designed to reduce the prevalence of Salmonella and Campylobacter in poultry.

According to Vilsack, this will be the first time the standards for chicken have been revised since 1996, and the first time the turkey standard have been revised since originally set in 2005.

In particular, the new performance standards will set the maximum positive rate for Salmonella in raw chicken carcasses at 7.5 percent, which represents a significant decrease from the current stanndard of 20 percent . The new performance standard for Campylobacter would allow roughly 46 percent of raw carcasses to test positive.

According to National Chicken Council spokesman Richard Lobb, a USDA baseline study from data collected from July 2007 to June 2008 showed an industry-wide 8.1 percent positive rate for Salmonella and a 40 percent positive rate for Campylobacter. For 2009, he said that the positive rate for Salmonella actually decreased to 7.1 percent. For this reason, Lobb explained that "the new standards are generally consistent with industry performance in recent years." In turn, Vilsack has indicated that the USDA hopes to have the new standards in place between July 1 and August 1, 2010.

In addition to unveiling the new performance standards, the USDA also announced that FSIS has developed the third edition of its compliance guide for poultry slaughter. Click on the following link to view the revised FSIS Compliance Guide.

The new guidance materials include additional and revised pre-harvest recommendations designed to assist processors in their continuing efforts to reduce these pathogens to the greatest extent possible. 

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According to the CDC, incidence rates of E. coli O157:H7 decreased significantly in 2009 from recent averages, reaching the lowest level since 2004.

Moreover, for the first time, the number of reported cases actually fell below the federal 2010 Healthy People target of less than one case per 100,000 people.

As explained by Dr. David Goldman, assistant administrator of the FSIS Office of Public Health Science, the report “confirms our success in combating food-borne illness by setting an aggressive goal, designing an effective system to meet that goal, and [then] relentlessly implementing it.”

The most recent food-borne illness incidence data was collected and analyzed through FoodNet, a collaborative project including the CDC, USDA, FDA and various state health departments. FoodNet conducts active surveillance for nine pathogens, including Campylobacter, Cryptosporidium, Cyclospora, E. coli O157:H7, Listeria, Salmonella, Shigella, Vibrio and Yersinia. Click on the following link to learn how food-borne illnesses are tracked.

According to Dr. Chris Braden of the CDC, "the report indicates that there have been reductions in illness caused by many of these pathogens." Braden further explained that, “since FoodNet began surveillance in 1996, . . . [most] of the pathogens that we track have all declined."

And, while E. coli O157:H7 and shigella cases showed encouraging recent declines, the federal targets for Campylobacter, Listeria, Salmonella and Vibrio have not yet been met. Vibrio infections, for instance, increased by 85 percent compared with the first three years of surveillance, and Salmonella fell short of the goal.

Many Vibrio infections result from eating raw or undercooked shellfish, especially oysters. In turn, Salmonella is often difficult to combat because it can originate and spread from a wide variety of foods and environmental sources. In addition to foods, Salmonella has been associated with animals like baby chicks, small turtles, reptiles and frogs. And, as noted, while incidence levels for campylobacter and listeria continued to decline significantly, they still did not meet "Healthy People" targets.

In addition to the expected Senate passage of the Food Safety Modernization Act next month, the FDA is also moving forward with additional food safety initiatives aimed at decreasing food-borne illness. Dr. Jeff Farrar, the FDA’s associate commissioner for food protection, noted that the agency is still pursuing new requirements aimed at reducing the incidence of Salmonella during shell egg production. These initiatives are expected to become effective this summer, while FDA also works to develop a proposed rule which will likely include risk-based safety standards for produce.

If we are really serious about reducing food-borne illness, however, such initiatives and regulations are only one part of the overall equation. Much greater progress can likely be achieved – more quickly – if more consumers recognize the importance of properly handling and preparing raw animal foods. If all consumers can be educated to assume raw chicken, meat and eggs carry bacteria that can cause illness, to take additional precautions to avoid cross-contamination, and to cook all raw animal products to a safe temperature, consumers can significantly reduce their risk of becoming ill.

In this regard, better “Educated People” will more quickly and readily translate into far more “Healthy People.”

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The recent hydrolyzed vegetable protein (“HVP”) recalls may force certain food processors to refine their product formulations which, by extension, could implicate current product labels.

To the extent that any ingredient revisions would force existing labels out of compliance, the FSIS has announced that an establishment should seek “temporary approval” for the continued use of existing labels. According to FSIS, the temporary approval will extend to any products in which HVP ingredients are removed or replaced with a non-allergenic substitute. Ultimately, the purpose behind the announcement is to permit establishments to exhaust their existing label inventory, despite the reformulation of potentially affected products.

To obtain temporary approval (which can be granted for a period of up to 180 days), food companies should submit their request to the FSIS Labeling and Program Delivery Division. According to the agency, any requests which clearly indicate they are a result of the HVP recalls will receive expedited review. Although establishments will still be required to submit information that demonstrates they meet the conditions for temporary approval set forth in 9 C.F.R. 317.4(f) and 381.132(f), the agency’s stated goal is to grant any such applications within 24 hours. Click on the following link to view the FSIS’ Labeling Guidance.

In the event food companies have any additional or specific questions regarding the FSIS labeling guidance, or to the extent they need any additional assistance, they are invited to call the FSIS Labeling and Program Delivery Division at (301) 504-0878 or (301) 504-0879.

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The FDA's Reportable Food Registry ("RFR") first went online in September 2009.

Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.

Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.

Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.

In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.

Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. As explained by the FDA, some examples of reasons a food may become reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, in addition to other exceptions, the FDA’s reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry.

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The FDA's Reportable Food Registry ("RFR") first became active in September 2009. 

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, a food company may be required to alert the FDA (through the RFR Portal) within 24 hours of becoming aware it has received, sold or shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. 

Because reporting is only required under specific circumstances, however, any company uncertian about its reporting duties should seek legal advice to determine the extent and scope of any reporting requirements under the RFR.

For additional information on the registry and reporting obligations, please visit www.fda.gov/ReportableFoodRegistry.

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Shortly after the 1993 Jack in the Box outbreak, the Food Safety Inspection Service (“FSIS”) issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. Since this announcement, and as things currently stand, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.

In October 2009, however, Bill Marler (a national plaintiffs’ food lawyer) petitioned FSIS to issue an interpretive rule declaring all enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of E. coli, including all non-O157 serotypes, to be adulterants in ground beef within the meaning of the Federal Meat Inspection Act. Click on the following link to view a copy of the Marler Clark Non-O157 STEC Petition.

According to Marler, there have been numerous food-borne illness outbreaks involving non-O157 STECs over the last 20 years which, in his view, justify a change in current FSIS policy. Despite the underlying implication that non-O157 STECs are and will continue to be a growing national problem, however, very few reported outbreaks have been associated with these pathogens in the United States.

Even FSIS agrees that outbreaks may be rare. At its 2007 non-O157 STEC Policy Meeting, FSIS noted that there have been only 13 outbreaks since 1990 associated with non-O157 STECs in the United States. Notably, of the 13 outbreaks that were reported, many were attributable to fresh produce, and none were associated with ground beef. Additionally, in 2005, CDC reported that there had been only 501 confirmed cases nationwide.  While these low numbers may ultimately be explained in part by limited testing, it may also be premature to conclude outright that non-O157 STECs are so predominant as to justify an overhaul of the current FSIS approach to pathogen testing and regulation.

FSIS agrees that available data is sparse and may not support a change at this point in FSIS policy. In its recent response to the pending petition, FSIS confirmed that “the agency cannot reach a decision about the substance of the petition until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.” Click on the following link to view the FSIS Response to Marler Clark Petition.

Although FSIS plans to conduct additional research in this area, the agency concedes that, given the current limits of available data, it cannot effectively identify or even address the potential issues with these organisms. And, although additional research will eventually be completed, it remains to be seen whether the resulting findings will ultimately support the conclusion that non-O157 STECs are and should be treated as a significant and wide-spread public health concern in the United States.

In any event, based upon FSIS’ response, it does not appear that the agency will be taking any action on the petition soon. Thus, at least in the short-term, we will likely be left watching - with interest - as numerous scientists and public health officials continue to chew on this issue.

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In a recent speech, USDA Deputy Under Secretary for Food Safety Jerold Mande outlined various areas of research he believes will help improve food safety.

During his remarks, Mande noted that he would like to push for more rapid and effective testing. "We need better sampling methods, along with tests that more rapidly detect a broader range of harmful pathogens," he said. "We also need stronger assurance that laboratories used by companies have the expertise and experience to do effective food safety testing."

In addition, Mande stated that FSIS inspectors should be given more sensitive and effective ways to detect food-borne hazards. Here too, Mande opined that the agency “needs to do a better job equipping our inspectors with the means to not let harmful pathogens slip by as we stand watch."

Next, Mande called for additional research to better identify what he referred to as “those unidentified pathogens” which could potentially be responsible for a majority of food-borne illnesses in the United States. According to the CDC, as many as 80 percent of illnesses, 70 percent of hospitalizations and 65 percent of deaths could be caused by agents other than the 30 pathogens CDC currently tracks.

Finally, Mande also suggested, and rightfully so, that additional research was needed to give farmers and ranchers better tools in order to fight food-borne pathogens. "To take the next big step forward on food safety we need to do more to have fewer pathogens on food animals when they arrive at the slaughterhouse gate," he concluded.

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Although most people believe that the decision to develop and utilize ground-breaking food safety technology rests exclusively in the hands of industry, this view is often mistaken.

Rather, the use of most new interventions that could immediately increase the safety of our food depends, not upon industry, but upon the approval of the federal government. And, when federal officials refuse or fail to act, both industry and consumers can suffer.

In 2004, the American Meat Institute (AMI) submitted a petition to FSIS to approve the use of carcass e-beam irradiation technology in meat plants. AMI requested that the petition be granted so that low levels of irradiation could be applied to the surface of chilled beef carcasses as a food safety processing aid. The use of such technology has proven to be an effective measure in reducing the presence of pathogens in raw meat products.

And yet, despite the obvious food safety advantages, the agency has for five years refused to approve use of the technology. To the surprise of many, agency officials announced in a recent meeting with the North American Meat Processors Association (NAMP) that no decision would be forthcoming soon.

Presumably, the reason carcass irradiation is an issue with FSIS is because AMI requested that it be approved as a “processing aid.” If the request was granted, processors would be allowed to use the technology without having to place special labels on meat processed with the intervention. Without specifying what, exactly, it was referring to, however, the FSIS stated simply that, “because of other recent events, processing aids in general are under greater scrutiny right now."

Although all of this may be true, with an increasing ability to detect food-borne illnesses and outbreaks nationally, the overall safety of food is under greater scrutiny as well.

In any event, carcass irradiation has often been cited by the meat industry as viable way forward in the fight against E. coli O157:H7 in ground beef. Keeping the word "irradiation" off labels, or even changing its description to something like "pasteurization," have been suggested as ways to increase public acceptance. This is because, previously, the use of low levels of irradiation to treat finished ground beef products fell flat, in large part, because the USDA required the use of a radura symbol on ground beef labels which simply scared the public away.

Frustrated by the lack of progress on its long-standing request, the AMI recently sent a letter to FSIS officials urging them to take action on the outstanding petition. FSIS then responded by saying the issue was being held up because it was waiting for the AMI to answer some of its queries on the petition. AMI, however, reported that it had never received any questions or concerns from the agency.

The controversy intensified last week when, as noted, FSIS informed NAMP of its intent not to grant the petition. When FSIS was asked to provide additional details regarding the continuing delay, it again stated that “AMI [still] needs to provide answers to [FSIS’] questions in order for FSIS to be able to act further on the petition.” Once again, however, the meat association denied being contacted by the FSIS, stating it had “received no formal response to [the] petition, including any questions or concerns that FSIS may have”.

AMI executive vice president James Hodges stated further that there was no reason to continue delaying evaluation of the matter. “AMI has submitted all information needed for FSIS to . . . publish a proposed rule regarding treating carcass surface irradiation as a processing aid”, he said. “Questions or issues about the technology [can be] best addressed through the rulemaking process that will be required to establish the parameters regarding applying this proven food safety technology. We look forward to a favourable response from FSIS.”

Having defended well-intentioned food companies for nearly ten years, and having witnessed the onslaught industry has received recently from media and congress for “failing to do more,” I am perplexed at the lack of urgency displayed by the agency. Perhaps this is yet another example of how government, rather than solving our problems, can often make them worse.

Thus, we too urge FSIS to take action on AMI’s proposal. If we truly want to advance food safety, we should start by convincing our government to advance those technologies that make it possible.

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Dr. Elisabeth Hagen has been selected to become the USDA’s newest Under Secretary for Food Safety. If confirmed, Hagen will serve with Agriculture Secretary Tom Vilsack.

"There is no more fundamental function of government than protecting consumers from harm, which is why food safety is one of USDA's top priorities," said Vilsack. " Dr. Hagen brings the background, skills, and vision to lead USDA's efforts to make sure that Americans have access to a safe and healthy food supply."

The Food Safety mission of USDA includes the Food Safety and Inspection Service (FSIS), which is the public health agency in the USDA responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

Dr. Elisabeth Hagen currently serves as the USDA's Chief Medical Officer, serving as an advisor to USDA mission areas on a wide range of human health issues. Prior to her current post, she was a senior executive at FSIS, where she played a key role in developing and executing the agency's scientific and public health agendas. She has been instrumental in building relationships and fostering coordination with food safety and public health partners at the federal, state, and local level.

Before joining the federal government in 2006, Hagen taught and practiced medicine in both the private and academic sectors, most recently in Washington, DC. She holds an M.D. from Harvard Medical School, and a B.S. from Saint Joseph's University. Dr. Hagen completed her specialty medical training at the University of Texas Southwestern and the University of Pennsylvania, and is board certified in infectious disease. She is married and lives with her husband and two young children in Northern Virginia.

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By Guest Blogger Cathy Crawford

The proposed regulations which are part of the Food Safety Modernization Act include provisions for mandatory recalls. While in rare cases, such provisions could potentially be helpful where a company is reluctant to conduct a recall, the vast majority of recalls are not only voluntary and effective, but often go above and beyond what may soon be defined as “requirements.”

Consider, for instance, the recent recall of various canned Slim-Fast products. Unilever should be commended for its voluntary and precautionary actions. In this regard, it is critical to note that there were no illnesses associated with the consumption of these products. Rather, a potential food safety issue was identified internally by the company and then immediately reported. Thus, this is not a case that demonstrates the importance of, or need for, additional government oversight. Rather, this was a responsible company which, on its own accord, accepted the need to react, and did react, proactively to address possible food safety concerns.

Next, and even more important, is the size of the recall. Large recalls sometimes lead the media and consumers to believe that our great American food supply is unsafe. This recall, however, demonstrates just the opposite. For Unilever, it was likely that the exact cause of the potential problem was not immediately understood. Nevertheless, all of the potentially affected products involved in the recall were simply assumed by the company to be possibly – not factually – contaminated. In truth, there may have been one contaminated container, none, or many. Because the company wanted to react quickly, however, it initiated a very expansive recall, hoping the public would respect its actions, rather than judging it for having produced a suspect product.

Often, the behind the scenes, certain data driving the scope and limits of a recall are not fully available to the public. In turn, what consumers see or believe is only that a company released a food product later subject to a recall, and then had to have it returned so it could be safely discarded. What is rarely explained is that most of the food involved in any recall is completely safe. Because it can’t quickly be "proven" to be either safe or unsafe, however, it is voluntarily recalled, in an abundance of caution, to remove all potential risk.

If, or more likely when, recalls become “mandatory,” most companies will of course strive to comply with those requirements imposed by the relevant federal agencies. In doing so, however, some companies may become dependent upon federal regulators to define the scope of a recall, and thus overlook the opportunity to do more than what is being strictly required. Thus, although we may see routine compliance, we may also witness a potential loss in some of the extraordinary efforts taken by companies when they themselves voluntarily define the scope of a recall and go the extra mile in the name of public confidence and food safety.

Thus, in my view, additional and pointed regulatory power in such circumstances may not be the best answer. Instead, a coordinated effort to increase and enhance industry education may be a better long term solution. Imagine, for instance, the difference of having careful drivers in a school zone where the community uses education and training to instill an authentic sense of care about driving near schools. Compare this to a place where the time allotted for drivers’ education courses has been reduced, but drivers are expected to travel at 25 mph only because it is mandatory. In the end, which environment is safer? In which case are drivers likely to push the limit farther, and drive a bit faster, when no one is looking?

I would rather see additional resources diverted to increased awarness and training than simply trying to legislate a quick solution to a perceived problem by empowering and then expecting regulators to both define and then require “mandatory recalls.” Remember the drivers’ educational videos that may have scared you and convinced you of the power in your hands when at the wheel? Perhaps something similar, along with increased annual Hazard Analysis and Critical Control Point (“HACCP”) and food safety training, would do more for our system than additional legislation.

The food safety systems in many companies include HACCP protocols as well as systems in compliance with globally accepted food safety standards such as the Safe Quality Foods (SQF) or the British Retail Consortium (BRC). There are times when these systems might fail to identify or prevent a hazard. In these cases, however, responsible companies most often act proactively and quickly to implement corrective actions. Those actions include protecting the public, finding the cause of the problem, eliminating that cause, and updating internal systems to ensure any changes are effective. These things don’t happen without training. No legislation can replace that.

Nevertheless, a mandatory recall provision will likely pass. Without robust and effective food safety training at all stages in the food chain, however, this by itself will not likely diminish the need for recalls, nor will future recalls become any more efficient or effective.

* Cathy Crawford serves as a consultant with the HACCP Consulting Group (HCG), based in Fairfax, VA, just outside of Washington, DC.

HCG provides food safety consulting services to the food industry. Founded in 1994, HCG offers food safety training and assistance to both the FSIS and FDA regulated food industry as well as in over 35 countries that export meat and/or poultry to the U.S. Five of HCG’s 10 partners are former FSIS officials with the others from the food industry and state inspection programs. We have basic and advanced HACCP training courses accredited by the International HACCP Alliance in College Station, TX. HCG also provides Serve Safe training to the restaurant industry and has provided food safety training at a well know Culinary Institute. For more information about HCG please visit HCG’s web site at www.haccpcg.com.

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The USDA’s Food Safety and Inspection Service (“FSIS”) has announced the creation of a new help-desk, providing operators of small meat, poultry and egg processing establishments with access to knowledgeable specialists who can help them understand USDA directives, regulations and other information. The help-desk also will provide direct assistance to state and local food regulatory agencies.

"The FSIS is committed to providing assistance to businesses of all sizes that provide American consumers with access to a safe and healthy food supply," said Deputy Under Secretary for Food Safety Jerold R. Mande. "The small plant help-desk will help the development of small, local producers by offering a one-stop shop for questions about how to make sure their meat, poultry and processed egg products are safe, wholesome and properly labeled."

The new help-desk will support USDA's "Know Your Farmer, Know Your Food" initiative by helping small processors to reduce the time and expense of dealing with agency requirements. "Know Your Farmer, Know Your Food" is designed to continue the national conversation about developing local and regional food systems and finding ways to support small and mid-sized producers. It emphasizes the need for a fundamental and critical reconnection between producers and consumers, building on the 2008 Farm Bill, which provides additional flexibility for USDA programs to promote local foods. More information on the "Know Your Farmer, Know Your Food" initiative can be found at: www.usda.gov/knowyourfarmer.

The FSIS small plant help-desk will serve as a "one-stop shop" for plant owners and operators with questions. More than 90% of the 6,000 plants inspected by FSIS are small or very small. FSIS staff will assess callers' requests and provide information and guidance materials that best meet their needs. In situations where the answer is not readily available, the staff will research the issue and follow-up with the caller. As appropriate, the help-desk will provide a portal to other services, such as AskFSIS, FSIS' existing service offering agency responses to inquiries on agency policy.

Inquiries can be made to the small plant help-desk by toll-free telephone or by email. The help-desk is open from 8:00 a.m. - 4:00 p.m. EST, Monday through Friday, excluding Federal holidays. To speak to a staff specialist during this time, call 1-877-FSISHelp (1-877-374-7435). You may also contact the help-desk by email at InfoSource@fsis.usda.gov.

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It's not www.foodsafetycounsel.com.  But, it may be a close second.

Numerous food safety improvement measures have been initiated in the United States this year. One of the latest, unveiled by the FDA, USDA and Department of Health and Human Services, is a food safety website. The website, www.foodsafety.gov will provide a broad variety of information relating to food safety, including recall information and food handling tips. It will include news and information from each of the governmental agencies including FDA, USDA and CDC responsible for overseeing food safety in the United States.

The site, which is described as a gateway to federal food safety information, provides a wide array of information and resources for consumers to utilize. Among the numerous tools available on the site, are food safety educational materials for download, information about pathogens, podcasts and also an “ask a question” link whereby a consumer can receive an answer to a specific question.. The food safety information is broken down by food groups. It is both easily navigable and readily accessible.

According to the Food Safety Working Group, the federal government will continue “to enhance www.foodsafety.gov to better communicate information to the public and include an improved individual alert system allowing consumers to receive food safety information, such as notification of recalls. Agencies will also use social media to expand public communications.”

Future plans include expanding the website to have mobile access and text alerts.

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The USDA has published new rules for a proposed program, under which select State-inspected establishments (with 25 or fewer employees) will be eligible to ship meat and poultry products in interstate commerce. Click on the following link to view the Proposed Rule.

The new program was created as part of the 2008 Farm Bill to supplement the existing Federal-State cooperative inspection program to allow State-inspected plants with 25 or fewer employees to ship products across State lines. This announcement is part of the USDA's new Know Your Farmer, Know Your Food Initiative, which seeks to better connect consumers with local producers to help develop local and regional food systems to spur economic opportunity.

"This new cooperative interstate shipment program will provide new economic opportunities for many small and very small meat and poultry establishments, whose markets are currently limited," said USDA Deputy Under Secretary for Food Safety Jerold Mande. "We can provide new markets for these establishments, while maintaining the integrity of the Federal mark of inspection."

Currently, 27 states operate State Inspection Programs for meat and poultry, and FSIS verifies that the State programs are implementing requirements that are "at least equal to" those imposed under the Federal meat and poultry products inspection acts. Click on the following link to view the Current List of Qualifying States. For these programs, FSIS provides up to 50 percent of the State's operating funds and provides oversight and enforcement of the program.

Under the proposed rule, selected establishments will receive inspection services from federally trained and/or supervised State inspection personnel who will verify that the establishments meet all Federal food safety requirements. Meat and poultry products produced under the voluntary cooperative program will bear an official USDA mark of inspection, thereby enabling interstate shipment of the products.

State-inspected establishments that are not selected for the voluntary cooperative program, including state-inspected establishments with more than 25 employees, are only eligible to sell and ship their products within their State.

Comments must be received on or before Monday, November 16, 2009, through the Federal eRulemaking Portal at www.regulations.gov, by mail to: FSIS Docket Room, USDA, FSIS, OPPD, Docket Clearance Unit, 5601 Sunnyside Avenue, Stop 5272, Beltsville, MD 20705.

All comments must identify FSIS and the docket number FSIS-2008-0039. Once received and published, interested parties will be able to View All Comments Online.

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The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.

Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.

Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry

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At a recent conference focused on the prevention of E. coli, the USDA came prepared to comment on its current thinking relating to new and emerging policy initiatives. In turn, Dan Engeljohn (Deputy Assistant Administrator of the FSIS Office of Policy and Program Development) offered a number of pointed observations.

In cases involving a further processor which commingles raw materials from multiple suppliers, it can sometimes be difficult to trace the source of a subsequent outbreak to a single supplier. As a result, Engeljohn explained that the USDA is currently analyzing the merits of using the internal microbiological testing data generated by a further processor of product testing positive for pathogens to help the agency trace the pathogen back to the originating slaughter facility.

With respect to slaughter facilities themselves, Engeljohn also announced that the USDA may issue criteria for assessing prudent "high event day determinations.” Although the USDA concedes that 100 percent testing at any large slaughter operation would likely produce at least some positives during any given day of production, Engeljohn noted further that a large number of positives in a short period of time could potentially be a red flag.

Engeljohn also confirmed that the USDA is continuing its work on validating the methodology for testing and identifying non-O157 Shiga Toxin-Producing E. coli (STECS), from six serogroups (O26, O103, O111, O121, O45 and O145), in FSIS samples. Once sufficient baseline data can be collected and assessed, the agency will likely make a determination whether to classify any of these pathogens as adulterants in raw ground product. In addition, although whole-intact cuts of beef containing E. coli O157:H7 are not considered adulterated under current law, Engeljohn suggested that USDA is continuing to consider whether it may someday modify this standard.

Moving forward, we will, of course, continue to report on new and emerging developments.

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Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius have announced that “prevention and partnership” will guide their departments' efforts to safeguard our food supply. These announcements are based on the public health principles embraced by the White House Food Safety Working Group led by Sebelius and Vilsack.

According to Vilsack, "making prevention a priority is critical to reducing food-borne illness and one of the three food safety principles of President Obama's Food Safety Working Group.” In turn, Vilsack and Sebelius announced the following new initiatives designed to accomplish these goals.

Beef Safety - E. Coli Testing Of Bench Trimmings

For starters, the USDA's Food Safety Inspection Service (FSIS) is issuing guidance for inspectors to begin conducting routine sampling of bench trim for E. coli. In the past, the FSIS had not routinely tested bench trim. Rather, FSIS started E. coli O157:H7 testing with ground beef, and expanded testing to other beef components used in ground beef. Bench trim, which will now be tested as well, includes pieces left over from steaks and other cuts that are then used to make ground beef. FSIS is also issuing streamlined, consolidated instructions to its personnel for inspection, sampling and other actions to help reduce E. coli O157:H7 in beef. Click on the following link to view a copy of the FSIS Sampling Notice.

Produce Safety – New Draft Guidance

Secretary Sebelius also praised new draft guidances prepared by the FDA, an agency within HHS, aimed at minimizing contamination in leafy greens, tomatoes, and melons. According to Sebelius, "the proposed controls provide a guide for growers and processors to follow so they may better protect their produce from becoming contaminated." The draft guidances also represent a shift in strategy for the FDA, from a food safety system that often has been reactive to one that is based on preventing food-borne hazards. Click on the following link for information on the Draft FDA Guidances.

Although the new controls are aimed at preventing contamination in the first instance, Secretary Sebelius also confirmed that consumers play a vital role in ensuring the safety of the fresh produce they eat. In turn, she offered the following tips from the CDC:

• Buy wisely. Don't buy produce that is bruised or damaged. When buying fresh cut produce, choose only items that are refrigerated or surrounded by ice.

• Refrigerate promptly. Certain perishable fresh fruits and vegetables (e.g., strawberries, lettuce, herbs, and mushrooms) should be stored in a clean refrigerator at a temperature of 40ºF or below. If you aren't sure whether an item should be refrigerated, ask your grocer. Produce that is purchased pre-cut or peeled should be refrigerated within two hours.

• Prepare produce with clean hands. Wash hands for 20 seconds with warm water and soap before and after preparing fresh produce.

• Wash produce thoroughly. Rinse fruits and vegetables under running water. Scrub firm produce such as melons and cucumbers with a clean produce brush. All unpackaged fruits and vegetables, as well as those packaged and not marked pre-washed, should be thoroughly rinsed before eating. This includes produce grown conventionally or organically at home, or produce from a grocery store or farmer's market.

• Do not cross contaminate. Don't give bacteria the opportunity to spread from one food to another. Consider using one cutting board only for foods that will be cooked such as raw meat, and another one for ready-to-eat foods such as raw fruits and vegetables.

According to FDA Commissioner Margaret A. Hamburg, the new draft guidances embody the Administration’s and FDA’s prevention-oriented food safety strategy.” She also confirmed that, while the proposals are still in draft form, “they will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

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After failing to pass a  vote in the House of Representatives on Wednesday (July 29), the Food Safety Enhancement Act of 2009 (H.R. 2749) returned to the House floor for a second vote on Thursday (July 30).  

On the second try, the Dingell-Waxman bill, designed to modernize the FDA’s food safety authority, passed by a vote of 283 - 142. Click on the following link for a summary of the legislation.

Key provisions of the bill include the following:

• Inspections: Food and Drug Administration inspections of food facilities would increase from about once every 10 years to at least annually for high-risk facilities and at least once every three years for facilities deemed a low risk. FDA inspectors will have access to company records.

• Registration: Food processors, importers and other food handlers must register annually with the FDA and pay a yearly fee of $500 for each food facility.

• Recalls: The FDA could mandate the recall of tainted foods, instead of relying on food makers to pull items voluntarily.

• Safe practices: For the first time, the FDA could set standards for safe production of food on farms, as well as require food manufacturers to meet safety standards.

The 132-page bill now goes to the Senate where Illinois Democrat Dick Durham is waiting with his own bill.   Any differences between the House and Senate versions will likely be resolved by Conference Committee. Reportedly, President Obama already endorsed the House bill before Thursday’s successful vote.

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The FDA has announced a new regulation which it expects to prevent approximately 80,000 cases of food-borne illness (and 30 deaths) caused each year by Salmonella Enteritidis in eggs.

The final rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (74 FR 33030), requires manufacturers to employ additional preventive measures during the production of shell eggs in poultry houses, and mandates subsequent refrigeration during storage and transportation. Click on the follwing link to view a copy of the FDA Final Egg Rule.  According to the FDA, the implementation of such measures could potentially reduce the number of Salmonella infections from eggs by nearly 60 percent.

“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today's action will prevent thousands of serious illnesses from Salmonella in eggs.”

Salmonella Enteritidis can be found inside eggs that appear perfectly normal. Eggs in the shell can become contaminated on the farm, primarily because of infection in the laying hens. If the eggs are subsequently eaten raw or undercooked, the bacterium can cause illness.

The new rules requires that measures designed to prevent Salmonella be adopted by virtually all egg producers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to ensure their safety.

Producers with at least 3,000 but fewer than 50,000 laying hens must comply within 36 months after the rule’s publication. Producers with 50,000 or more laying hens must be in compliance with the rule within 12 months after its publication in the Federal Register.

Under the rule, egg producers must:

• Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria;

• Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment;

• Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an 8 week time period (4 tests at 2 week intervals); If any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use;

• Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis; and

• Refrigerate eggs at 45 degrees Fahrenheit temperature during storage and transportation no later than 36 hours after the eggs are laid.

Egg producers whose eggs receive treatments such as pasteurization must still comply with the refrigeration requirements. Similarly, certain entities such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration mandates.

To ensure compliance, egg producers must also maintain a written Salmonella Enteritidis prevention plan and associated records documenting compliance. Producers (except those who have less than 3000 hens or who sell all their eggs directly to consumers) also must register with the FDA. In turn, the FDA will develop guidance and enforcement plans to help egg producers comply with the rule.

The FDA has estimated that the rule would provide $1.4 billion in annual public health benefits, at an annual cost of $81 million to the regulated industry, or less than 1 cent per dozen eggs produced in the United States.

The new rule is part of a coordinated strategy between the FDA and the FSIS. The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.

In addition to the new safety measures being taken by industry, consumers can also reduce their risk of food-borne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, to make sure eggs in the carton are clean and not cracked, and to cook eggs (and any foods containing eggs) thoroughly.

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Agriculture Secretary Tom Vilsack has announced the appointment of Jerold R. Mande, M.P.H., as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA). In this position, Mande will have responsibility for the Food Safety and Inspection Service (FSIS), the USDA agency which protects public health through food safety and defense by ensuring that the nation's supply of meat, poultry and processed egg products are safe and wholesome.

According to Vilsack, "Jerold Mande brings years of experience in health, nutrition and epidemiology, food safety, and public policy in both government and academia that will greatly serve USDA and the public as we continue to work to protect public health."

Most recently, as Associate Director for Public Policy at the Yale Cancer Center, Yale University School of Medicine, Mande developed a national model to increase support for cancer prevention and control, including diet, exercise, and obesity. He also initiated and helped manage the cancer center disparities program, to improve cancer control and care in underserved populations. He was also a lecturer in public health, and helped train select groups of physicians for careers in public policy.

Prior to this, Mande served on the White House staff as a health policy adviser where he helped lead key food safety, tobacco control and cancer initiatives, including expansion of FoodNet and PulseNet. He was Deputy Assistant Secretary for Occupational Health at the U.S, Department of Labor. He also served as Senior Advisor and Executive Assistant to the Commissioner of the Food and Drug and Administration, where he led design of the Nutrition Facts food label, for which he received the Presidential Award for Design Excellence. Mande began his distinguished career in the U.S. Congress where he was first hired to work on food safety legislation.

Mande holds a Masters Degree in Public Health (M.P.H. Nutrition and Epidemiology) from the University of North Carolina at Chapel Hill and a Bachelor of Science Degree, magna cum laude (B.S. with Distinction in Nutritional Sciences) from the University of Connecticut at Storrs. He also attended the John F. Kennedy School of Government, Harvard University, completing a Program for Senior Managers in Government.

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The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived in March 2009 to help modernize our food safety system. In turn, Vice President Biden, Sebelius and Vilsack, have now announced key findings of the Group.

Following numerous meetings, and imput from key stakeholders, the Working Group has recommended a new approach to food safety based on three core principles: (1) prioritizing prevention; (2) strengthening surveillance and enforcement; and (3) improving response and recovery.

"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe," said Vice President Biden. "Our food safety system must be updated – 1 in 4 people get sick every year due to food-borne illness, and children and the elderly are more at risk. I applaud the Secretaries of HHS and the USDA for tackling this problem head-on, and coming up with key recommendations to ensure the health and safety of our food supply and, with it, the American people."

"Instead of spending their time trying to get kids to eat healthier food, too many parents and families are worrying about whether their food is safe in the first place," said Secretary Sebelius. "In just the past few months since we began work with the Food Safety Working Group, we have seen recalls on everything from spinach to peanut products to now even cookie dough.” According to Sebelius, the Administration believes “that the current system just isn’t working for America’s families, and under the President’s leadership, we are taking action to keep our food supply safe and prevent outbreaks that can impact millions of Americans."

"There isn’t a single American that isn’t impacted by our efforts to protect the food supply," said Secretary Vilsack. "We owe it to the American people to deliver on President Obama’s bold promise to greatly enhance our food safety system, moving our approach into the 21st century, employing the best surveillance techniques available, and ensuring that we are doing all we can to prevent illness before it occurs."

In its announcement, the Working Group outlined specific steps designed to advance its three core principles:

• HHS and USDA are targeting Salmonella contamination by developing tougher standards to protect the safety of eggs, poultry, and turkey.

• To fight the threat of E. coli, USDA is stepping up enforcement in beef facilities and the Food and Drug Administration (FDA) is developing new industry guidance improving protections for leafy greens, melons, and tomatoes.

• The Obama Administration is building a new national traceback and response system including clearer industry guidance, a new unified incident command system, and improved use of technology to deliver individual food safety alerts to consumers.

• Finally, the Administration announced a plan to strengthen the organization of federal food safety functions, including the creation of new positions at key food safety agencies and a continuing oversight role for the Food Safety Working Group.

The Food Safety Working Group is chaired by Secretaries Sebelius and Vilsack, and participating agencies include the FDA, the FSIS, the CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, the Environmental Protection Agency, and several offices of the White House.

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Following recent increases in public and media attention focused on food-borne illness, outbreaks and recalls, the House Energy and Commerce Committee has approved the Food Safety Enhancement Act of 2009. The proposed legislation is designed to enhance FDA food safety-related authority. 

The bill, H.R. 2749, passed the committee unanimously with an amendment that would exempt food production facilities and products regulated exclusively by the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act.  The bipartisan bill, spearheaded by Chairman Henry Waxman (D-CA) and Chairman Emeritus John Dingell (D-MI), has received support from a broad coalition of consumer and public health organizations.

According to reports, the full House is expected to vote on the bill prior to the July 4 recess. Click on the following link to view a copy of the proposed legislation, as amended. If enacted, the bill would give the FDA new authority to create robust food safety standards, to establish rules for enhancing traceability, to increase inspections at high-risk facilities, to mandate food product recalls, and to enforce new penalties for violations of federal food safety requirements.

The legislation would also increase FDA funding to facilitate these efforts by requiring food companies to pay new annual registration fees of $500.

Although proposed food safety initiatives are also planned for debate in the U.S. Senate, these efforts, reportedly, may be stalled as a result of ongoing legislative efforts associated with proposed health care reform.

In any event, we’ll continue to report as the debate continues.

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Nearly five months after the new administration took office, there is still no indication when an undersecretary for food safety will be named. Secretary of Agriculture Tom Vilsack recently confirmed that the delay is due at least in part to the administration's commitment to avoid hiring former lobbyists.

According to Vilsack, those restrictions, coupled with continuing efforts to thoroughly evaluate all potential candidates, has taken significant time. Additionally, some leading candidates formerly under consideration have declined the position. Dr. Mike Doyle, director of the Center for Food Safety at the University of Georgia, for instance, reportedly passed on the invitation, stating he would prefer to continue his role at the University of Georgia.

When named, the new undersecretary will be forced to quickly address numerous emerging food safety initiatives. Although lobbyists claim it is hard for the FSIS to participate fully in the consideration of new initiatives without a sitting undersecretary, Congress nevertheless continues to debate new legislation, and the President's Food Safety Working Group continues to work toward framing new policy.

Thus, we look forward to a formal decision soon, such that all stakeholders can effectively participate in our continuing and collective efforts to strengthen food safety.

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The House Energy and Commerce Committee has released a discussion draft of the Food Safety Enhancement Act of 2009 which, if passed, would require food manufacturers to pay an annual fee of $1,000 to fund increased inspections by the FDA.

Under the draft bill, high-risk food production facilities would be inspected by the FDA every 6 to 18 months, while low-risk facilities would be inspected every 18 months to three years. In addition to the annual inspection fee, the legislation would also require food manufacturers to pay for costs associated with any additional inspections triggered by food product recalls.  Click on the following link to view a Summary of the Food Safety Enhancement Act of 2009.

The chairman of the House committee, Rep. Henry Waxman (D-Cal.), stated that the proposed legislation is aimed at protecting the nation's food supply. According to Waxman, the new bill “recognizes that the hallmark of strong food safety legislation must be a shared responsibility for food safety oversight between FDA and industry.”

Although food manufacturers are not currently required to pay FDA inspection fees, current budget requests for the FDA include $260 million in new food safety initiatives, with about 35% of that anticipated to come from fees paid for directly by the food industry. While food industry groups strongly support the broad goals of the new proposed food safety measures, questions have been raised about the timing of new fees. According to industry representatives, new inspection fees are being proposed at a particularly bad time, given the slowing economy, for both food companies and consumers alike.

Among other things, the proposed legislation would also require food manufacturers to better trace the food they manufacture abd sell, and would give the FDA authority to issue mandatory recalls. The bill, if passed, would also strengthen criminal and civil penalties for any food companies that fail to comply with federal regulations.

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The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived to help modernize our food safety system. The group intends to foster “collaborative partnerships with consumers, industry and regulatory partners” and, through a transparent process, “build a food safety system to meet the challenges posed by a global food supply in the 21st century.” Click on the following link to visit the President’s Food Safety Working Group Website.

Last week, the Food Safety Working Group held its first “Listening Session” at the White House. Participants included numerous stakeholders representing a diverse range of organizations. Secretary of Agriculture Vilsack, who delivered the opening remarks, told participants that food Safety is of the highest concern for all of us. Although Vilsack noted that “Americans enjoy one of the safest food supplies in the world,” he also stated that more can should be done to improve food safety at all levels. Vilsack’s remarks are included below:

Welcome. Thank you for taking time to join us this morning.

Food Safety is of the highest concern for all of us here today. While Americans enjoy one of the safest food supplies in the world, we have witnessed too many outbreaks that make us worry that the food on our dinner plate or in our child’s lunch box will harm instead of nourish. This is not acceptable.

Today is the beginning of a significant and critical process that will fully review the safety of our nation’s food supply.

President Obama has pledged his full support in this matter and has charged the Food Safety Working Group with examining all aspects of food safety, be it meat or produce, fresh or frozen, whether it is imported, or produced domestically.

This issue will be one of USDA’s highest priorities. We are in the midst of reviewing all of our statutory authorities, as well as administrative and regulatory steps we can take, to ensure that our actions support public health and consumer safety to the fullest extent.

We have reviewed the Federal Meat Inspection Act, looked over our existing Hazard Analysis and Critical Control Point regulations, reviewed our enforcement authorities, and looked at how we collect data. While we are doing a good job, we at USDA can always do better.

I’d like to outline several specific challenges we need your input on:

•  Prevention. The key to a functioning food safety system is preventing foodborne illness. That means robust standards and sufficient authorities to prevent illnesses from occurring. Both FDA and USDA have embraced this principle and we must have a consistent approach.

•  Surveillance and Response. Our regulatory agencies must actively watch for disease outbreaks and take rapid action to ensure that we have effective and targeted recalls. Such recalls are in the interests of public health and the strength of industry sectors that might otherwise be tarnished by massive recalls.

•  As many people know first hand, in this economy we do not have unlimited resources. Nor can we simply pass higher food production costs onto struggling consumers. We must ensure that we are allocating our food safety resources effectively and efficiently. That means focusing the most attention on the products that have the most potential to cause harm.

•  The safety of a product should not be determined by where it originated. We live in a global community and by working more closely with our partners around the world we can make sure that the food the US is importing is as safe as the food we are exporting.

 •  All parts of the food safety system need to coordinate and work together in a seamless fashion. The FDA and USDA must do a better job of coordinating and I know that Secretary Sebelius and I will drive our agencies to improve coordination.

•  Industry, government, and consumer: each of us brings a piece of the puzzle. We can only solve this if all pieces are represented. It is time for us to set aside past frustrations, collaborate, and move forward together.

Finally, we need to develop a way to measure our success. I am confident that by working together, we will make improvements to the safety of our food supply. But we need a way to track our progress both in the short and long term, so that we do not settle for merely okay, but continually strive for improvement. Lives are at stake and good is simply not good enough.

Thank you again for joining us today.

The Secretary also thanked the participants’ mutual commitment to food safety, highlighted the Administration’s broad support for the modernization of food safety initiatives, and pointed to new and enhanced coordination between HHS and USDA to support this goal.

ViIsack also challenged government, industry and consumers to work more closely to improve food safety. This is good advice.

In the end, we all shoulder responsibility (whether producing or preparing food) to ensure that the meals we serve to our families are, indeed, as safe as they can possibly be.

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Food safety has long been a battle fought on multiple fronts. Once again, the principle proves true. As we continue to report on the absence of effective food safety laws abroad, our colleagues here at home are working feverishly to improve the effectiveness and efficiency of our own food safety system.

Is it possible, some ask, that all federal food safety responsibilities might be integrated into a single food safety agency? Although not likely in the very short-term, it would seem, at the very least, that the table is being set. As the search continues for new solutions to new food safety challenges, Trust for America's Health, along with the Robert Wood Johnson Foundation, released a report advocating significant changes to our national food safety system. The report, Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, outlines various weaknesses in the current system, and proposes, among other things, numerous improvements to the food safety functions of the  Department of Health and Human Services (“HHS”). In essence, the report advocates (as a first step) the creation of a new, stand-alone food agency within HHS.

Currently, the Food and Drug Administration (“FDA”), an agency within HHS, has responsibility for regulating the safety of drugs, medical devices and many foods. Although the United States Department of Agriculture, through its Food Safety and Inspection Service (“FSIS”), is responsibile for all meat, poultry and egg products sold in interstate commerce, the FDA regulates the safety of virtually all other foods (Learn how our food is currently regulated). To view the current, rather confusing, organizational structure of the FDA, click on the following link :

To increase efficiency (and decrease confusion), the new report urges Congress to quickly create a stand-alone Food Safety Administration (“FSA”) within HHS. Conceptually, the proposal would effectively split the FDA into two seperate agencies, each operating on the same plane - one devoted to food and the other devoted to drugs and medical devices. While the FSA would be responsible for regulating food safety, the drug and device sections of the FDA would become a separate agency called the “Federal Drug and Device Administration.” According to the report, a stand-alone food agency would fix the following key weaknesses under the current  structure:

• Inadequate leadership, prioritization, and coordination within FDA: No FDA official whose full-time job is food safety has line authority over all food safety functions. FDA's three major food safety components are managed separately, hampering efforts to effectively prevent disease outbreaks.

• Inadequate technologies and inspection practices: Current laws and practices are antiquated. Existing laws date back to 1906 and 1938, and policies are disproportionately focused on monitoring food after it has been produced, instead of trying to prevent and detect problems throughout the entire production process. And, there is no system in place to keep inspection practices up-to-date with the constantly modernizing food production technologies and practices.

• Inadequate staffing and resources: The FDA's Science Board found the agency is chronically underfunded. While the U.S. Government Accountability Office reports the turnover rate in FDA science staff in key areas, including food safety, is twice that of other government agencies.

• Inadequate inspection of imports (my favorite): Only one percent of imported foods are currently inspected, even though approximately 60 percent of fresh fruits and vegetables and 75 percent of seafood Americans consume is imported.

A stand-alone food safety agency such as the FSA would also, according to the report's authors, result in integrated and accountable senior leadership, integrated public health and science functions, and integrated compliance and enforcement programs. Click here (or on the picture to the right) to view the proposed organizational structure of a new FSA.  Ultimately, according to Risa Lavizzo-Mourey, president and CEO of RWJF, the proposal contained within the report is needed to ensure that "food safety [becomes] a priority on the prevention menu." 

Notably, in addition to the significant proposed changes to the fundamental structure of FDA, the report advocates (as a second step) potential future changes to FSIS and other agencies as well. Although FSIS in the short-term would likey continue to operate within the USDA as a separate agency, the report ultimately recommends that all current federal food safety functions (including FSIS responsibilities) should eventually be integrated into a single food safety agency. Thus, although the proposed immediate changes to the FDA will likely garner the most attention as the report is studied and considered, pointed advocacy for a single food safety administration (for all federal food regulatory functions) will likely follow.

In any event, as part of its vision, the report also recommends that a spot at the table be cleared (assuming a new food safety agency is created) for a single Food Safety Czar. We, of course, will wait for a response from Congress and the Obama Administration before we offer our comments on potential candidates . . .

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In addition to peaches, we all know (now) that Georgia also dabbles in peanuts. Notably, the state is regarded as the nation's leading peanut producer, employing an estimated 50,000 people in an industry worth approximately $2.5 billion. Following the massive recalls of peanut butter products originally announced by the Peanut Corporation of America in January 2009, Georgia lawmakers introduced and passed a new bill that will make Georgia the first state to require food producers to inform state inspectors if test results show that their food products contain trace elements of harmful pathogens. 

Although, in the coming weeks (or months), the FDA will also begin requiring food manufacturers that obtain positive test results to report such findings to the agency, Georgia is the first individual state to enact such rules. Under the proposed legislation, state agriculture officials will be empowered to adopt regulations that will establish how frequently food processors must conduct internal testing. Similar to the looming federal requirements, the new rules will require food processors to report results within 24 hours of any positive test. The laws, as drafted, also exempt (of course) meat, poultry and other manufacturers that fall within the jurisdiction of the USDA.

The legislation has now passed in both the Georgia state Senate and House of Representatives. Governor Sonny Perdue is expected to sign the bill soon. 

Peachy.

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The USDA has granted a conditional license for the nation's first E. coli O157:H7 cattle vaccine. The vaccine is designed to reduce the level of E. coli O157:H7 in the intestines of host cattle, and to prevent the bacteria from spreading in feed lots.

Although additional efficacy tests still need to be conducted, the conditional license granted by the USDA will allow Epitopix LLC, the manufacturer of the vaccine, to begin offering the product for sale. The company developed the vaccine along with researchers from Kansas State University and West Texas A&M University.

During testing, researchers conducted a challenge study, a natural infection trial, and two large-pen field studies of the vaccine at commercial feedlots. According to reports, the vaccine reduced the number of cattle testing positive for the O157:H7 bacteria by 85 percent. Of the animals that did test positive for the pathogen, the vaccine reportedly eliminated 98 percent of the bacteria. "Those are impressive numbers," said Dr. Michael Doyle, director of the University of Georgia's Center for Food Safety. In turn, Jim Sandstrom, of Epitopix, confirmed that the vaccine “represents a significant breakthrough in the beef industry's ongoing effort to reduce E. coli O157:H7."

Following additional studies, Epitopix will likely gain full approval for the vaccine. The company estimates that, eventually, the vaccine will protect as many as 10 million cattle every year (about 1/4 of the country's annual cattle supply), and will likely cost less than $10 per head. One of the country's largest beef producers has already expressed interest in purchasing the vaccine.

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The Food Safety Inspection Service ("FSIS") has issued a new Notice (18-09), detailing its changes in sampling frequency for E. coli O157:H7 in raw ground beef. According to the notice, FSIS will be increasing sampling at high volume ground beef establishments at the following monthly rates:

• Up to four times within a 30-day window for establishments with ground beef product production volumes of greater than 250,000 pounds per day;

• Up to three times within a 30-day window for establishments with ground beef product production volumes of 50,000 to 250,000 pounds per day;

• Up to two times within a 30-day window for establishments with ground beef product production volumes of 1,000 to 50,000 pounds per day; and

• Generally, no more than once within a 30-day window for establishments with ground beef product production volumes of less than 1,000 pounds per day. However, FSIS will ensure that at these establishments at least one sample is collected quarterly.

According to the FSIS, the increase in sampling will allow the Agency to estimate the amount of uncontaminated raw ground beef with a higher degree of certainty. The Office of Public Health Science and the Office of Data Integration and Food Protection will analyze sample results, and will produce a weekly report on findings. According to the notice, the Office of Data Integration and Food Protection will also analyze the sampling data to identify trends (e.g., geographical, seasonal) and to evaluate program effectiveness (e.g. sample scheduling and collection rates). In addition, the data will be used to calculate a quarterly performance measure of E. coli O157:H7 in raw ground beef that will likely be included in the Agency’s quarterly performance report.

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Over the last decade, there have been numerous attempts to reform our food safety laws. As our ability to identify food-borne illnesses and outbreaks continues to improve (special thanks to the CDC, PulseNet and OutbreakNet), at least some weaknesses that were rarely, if ever, considered are now being found. Thus, although most meals consumed in this country remain perfectly safe, the recent peanut butter recalls have those advocating the need for additional checks and balances, at least for certain segments of industry, finding growing support.

Prompted by the recent recalls, lawmakers have proposed revised food safety legislation – the new FDA Food Safety Modernization Act -- which would give the FDA additional resources to more closely regulate food safety. The bipartisan bill was sponsored by Senators Dick Durbin (D-Ill.), Judd Gregg (R-N.H.), Ted Kennedy (D-Mass.) and Richard Burr (R-N.C.). A parallel bill, the Safe Food Enforcement, Assessment, Standards and Targeting Act of 2009, was also introduced in the House. The new legislation proposes to increase the frequency of inspections at food facilities, give the FDA expanded access to company records and testing results, and allow the FDA to mandate recalls if a food company fails to follow the agency's recommendations. As reported and summarized by Janie Gabbett, from Meatingplace.com, the new bill will specifically:

• Require all food production facilities to implement preventive plans to address hazards and prevent adulteration, and give the FDA access to the plans and relevant documentation;

• Expand the FDA’s access to records in a food emergency;

• Allow the FDA to recognize laboratory accreditation bodies to ensure food testing labs meet high quality standards, and to require test results to be reported to the FDA;

• Allow the FDA to enable qualified third-parties to certify that foreign food facilities comply with U.S. food safety standards;

• Require importers to verify the safety of foreign suppliers and imported food;

• Allow the FDA to require certification for high-risk foods, and to deny entry to any food that lacks certification;

• Increase FDA inspections at all food facilities, including annual inspections of high-risk facilities, and inspections of other facilities at least once every four years;

• Enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses;

• Require the Secretary of HHS to establish a pilot project to test and evaluate new methods for rapidly and effectively tracking/tracing fruits and vegetables in the event of a food-borne illness outbreak;

• Give the FDA the authority to order a mandatory recall of a food product when a company fails to voluntarily recall the product upon the FDA's request;

• Empower the FDA to suspend a food facility's registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death;

• Direct the FDA to help food companies protect their products from intentional contamination, and rapidly respond to food emergencies;

• Increase funding for the FDA's food safety activities through increased appropriations and fees for domestic and foreign facilities.

In addition to receiving bipartisan support, many food companies and industry organizations have voiced support for the bill as well. Vocal supporters include General Mills, Kraft Foods and Kellogg's, along with the Grocery Manufacturers Association, the National Restaurant Association and the Produce Marketing Association. As reported by FoodNavigator-USA.com, Kirstie Foster, spokesperson for General Mills, stated:

“We are strong advocates for food safety system modernization and reform. Ensuring food safety is the highest priority of our industry. We support reform that includes both greater authority and greater resources to strengthen our ability to prevent and respond to food safety issues.”

In turn, Kraft spokesperson Susan Davison agreed, indicating that “the proposed legislation will make significant improvements . . .” Such comments were also echoed by the GMA, in a statement issued by president and CEO Pamela Bailey:

“Ensuring the safety of our products is the food industry’s most important priority... In particular, GMA supports proposals requiring all food companies to have a comprehensive food safety plan in place. It is absolutely critical that manufacturers take a preventative approach in identifying and evaluating potential hazards, and building food safety into the manufacturing process from the very beginning.”

Finally, according to Supermarketnews.com, Tom O’Brien, a representative for the PMA, also expressed support:

“I think the bills, if they get enacted, will restore consumer confidence in FDA, which in turn restores confidence in the food supply. They modernize FDA’s authorities, and they tell it that they should regulate based on the risk of any particular commodity. Those are very important things that we look for in legislation.”

Although the proposed legislation, if passed, would likely strengthen what already is a robust food safety system, there is unfortunately no solution that can completely eradicate food-borne illness. Like the common cold, flu and other ailments, illness occurs because microscopic pathogens exist in our world and can very easily contaminate our environment, our bodies and our food. Even if present in only small amounts that avoid detection, these organisms can eventually grow and multiply to levels that cause illness (whether introduced at a production facility or anywhere in the distribution chain). Moreover, despite continued best efforts to test for and find these pathogens, nature will continue to do its best to avoid being caught. Thus, although the proposed legislation will not eradicate illness, we are hopeful the new initiatives will, at the very least, help us more proactively identify and solve potential problems before they occur. 

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Tom Vilsack, Secretary of the United States Department of Agriculture, announced that the final rule (74 FR 2658) for mandatory country-of-origin labeling (“COOL”) will become effective on March 16, 2009. Under the new rule, retailers will be required to notify customers of the country of origin of certain food products. Food products (or, “covered commodities”) included within the COOL program include whole muscle cuts, ground beef, lamb, chicken, goat and pork; wild and farm-raised fish and shellfish; perishable agricultural commodities (specifically fresh and frozen fruits and vegetables); and macadamia nuts, pecans, peanuts and ginseng. Additionally, for food such as fish and shellfish, the method of production, wild or farm-raised, must be specified.

Exempted from COOL, however, are various products (e.g., ingredients) used to manufacture “processed” food items. Processed foods are generally defined as: (1) any retail item derived from a covered commodity that has undergone specific processing resulting in a change in the character of the covered commodity; or (2) any retail item that has been combined with at least one other covered commodity or substantive food component. “Specific processing” that results in a change in the character of food includes cooking (e.g., frying, broiling, grilling, boiling, steaming, baking, roasting), curing (e.g., salt curing, sugar curing, drying), smoking (cold or hot), and restructuring (e.g., emulsifying and extruding). For this reason, Vilsack also expressed concerns, in an open letter to industry, that the definition of processed foods contained within the final rule "may be too broadly" drafted. Because Vilsack was also concerned about the labeling of products of mixed origins, and time allowances for labeling of certain ground meat products, he asked industry to voluntarily adhere to the following additional labeling practices:

• With respect to processed foods, Vilsack suggested that processors voluntarily use country-of-origin labeling for those products that "are subject to curing, smoking, broiling, grilling, or steaming."

• With respect to products derived from animals with multiple countries of origin, Vilsack asked processors to include labeling information identifying what production step -- born, raised and/or slaughtered -- occurred in each country.

• Finally, because final rule allows a label for a ground meat products to bear the name of a country when meat from that country was present in the processor's inventory within the last 60 days, Vilsack suggested that time allowance be reduced to 10 days.

American Meat Institute President J. Patrick Boyle stated that, despite Vilsack’s concerns, the organization was "gratified" that USDA is allowing the final rule to go into effect. Namely, this is because the new rule, in its current form, took nearly six-years (with assistance from industry) to develop. Boyle also noted that, once the rule is effective, nearly 95 percent of beef and pork products would likely be eligible to bear a "Product of the USA" label.

Nevertheless, Boyle also stated that it would ultimately be up to individual companies to decide whether to voluntarily comply with Vilsack’s recommendations. According to Boyle, "to the extent that companies are able and elect to go beyond [the] federal labeling requirements, as requested by Agriculture Secretary Vilsack, [that] is an individual company decision, which will have to be made in collaboration with a company's retail grocery customers . . .."

In any event, Vilsack confirmed that the USDA “will closely review industry compliance with the regulation and its performance in relation to these suggestions for voluntary action.” Depending upon such performance, the USDA “will [then] carefully consider whether modifications to the rule will be necessary to achieve the intent of Congress." The rule had also been under review on the orders of the new presidential administration. Ultimately, Vilsack stated that, allowing the rule to go into effect on March 16, 2009, and then monitoring implementation and compliance by industry, would likely be the most efficient way to evaluate the success of COOL, and also to determine whether additional rulemaking would be necessary.

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The State of California recently enacted a new criminal law, effective January 1, 2009, designed to prevent slaughterhouses from purchasing and processing non-ambulatory animals for human consumption. As enacted, Section 599f amended the California Penal Code to criminalize, without exception, the receipt and use of non-ambulatory animals by slaughter facilities.

In response, the National Meat Association (“NMA”) sought and obtained a preliminary injunction to prevent the State of California from enforcing the new law. NMA, et al. v. Brown et. al, Case No. CV-F-08-1963 (E.D. Cal. 2008). In its briefs, NMA argued that the treatment of non-ambulatory animals was already regulated extensively by the Federal Meat Inspection Act (“FMIA”), which expressly permits, subject to certain requirements, the receipt and use of non-ambulatory animals for slaughter. Under the FMIA (21 U.S.C. § 601, et seq.) and its implementing regulations, non-ambulatory animals may be processed for human consumption if the animals are first inspected for disease and then passed by a federal veterinarian inspector. Because the California law attempted to criminalize what the FMIA permits, NMA argued persuasively that the California initiative was preempted.

Indeed, the FMIA (a distant relative of the 1906 Wholesome Meat Act) regulates virtually every aspect of meat production. The Act requires continuous federal inspection in meat packing plants, often times by multiple inspectors. These federal inspectors are responsible for ensuring that all animals entering slaughter facilities are healthy and free from disease, and that all meat products subsequently produced from such animals are safe, wholesome and not adulterated. Currently, the federal statutory and regulatory scheme is enforced by the Food Safety Inspection Service (a sub-agency of the United States Department of Agriculture).

To ensure that the FMIA and its uniform national requirements are not usurped by the individual states, the FMIA contains an express preemption provision which prevents states from enacting or enforcing any laws that are “different” from the federal standards. 21 U.S.C. § 678. Thus, under the FMIA, any state laws which attempt to penalize a food producer for doing what federal law permits (whether the laws relate to production or product labeling) are strictly preempted.

In this case, the new California criminal law conflicted directly with the federal statutory and regulatory scheme. Because the FMIA permits the use of non-ambulatory animals for slaughter (assuming such animals have been declared to be free from disease by a federal FSIS veterinarian inspector), the Court granted NMA’s request for a preliminary injunction. In its February 19, 2009 Decision, the Court reasoned that the California Penal Code, Section 599f, was both expressly and implicitly preempted under the FMIA and its implementing regulations.

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Agriculture Secretary Tom Vilsack recently announced that, despite previous opposition, he now favors combining the food safety functions of the United States Department of Agriculture (“USDA”) and Food and Drug Administration (“FDA”) into a single food safety agency. Currently, the USDA through it’s Food Safety and Inspection Service (“FSIS”) is responsible for regulating the safety of meat, poultry and egg products. In turn, the FDA has responsibility for most other foods. In his recent comments, Vilsack also stated that he has not yet decided whether a single agency would be best located within the FSIS, the FDA or an independent agency.

As debate continues about merging the food safety responsibilities of the USDA and FDA, Janie Gabbett (from Meatingplace.com) reported that the majority of industry participants in an online survey favored combining the food safety regulatory functions of the USDA and FDA, but only one in five believed that such a merger would result in improved food safety.

Of 289 readers who responded to the survey, 58 percent agreed the two agency functions should be combined, while 42 opposed a merger. When respondents were asked if they thought that a merger of the two agencies would improve food safety, 50 percent believed that food safety would remain unchanged, while 30 percent believed that the quality of food regulation could actually decline.

According to the survey, participants were more concerned with deficiencies in FDA regulation than in FSIS protocols. Namely, this is because, unlike the FDA, FSIS inspectors currently maintain a continuous, on-site presence in meat packing facilities, and also regularly test meat and poultry products for harmful pathogens. As a result, several respondents also concluded that if the agencies were to merge, the FDA would need to become more like FSIS, and not the other way around.

Other suggestions from survey participants included:

• Providing better technology and tools for inspectors;

• Increased laboratory testing;

• Imposing fines on plants with repeated serious violations;

• Requiring all food establishments to adopt and implement Hazard Analysis and Critical Control Point (“HACCP”) plans;

• Requiring all food establishments to adopt and implement sanitation standard operating procedures (“SSOPs”);

• Continuing to improve risk-based analysis of food safety systems in plants;

• Targeting high-risk foods (under FDA jurisdiction) and moving toward to the USDA model of inspection;

• Providing better training for inspectors; and

• Funding additional research to improve food safety.

According to Gabbett, many respondents also believed that, even with a single food safety agency, increasing the funding and number of federal inspectors would likely be needed to improve the effectiveness of regulations. According to one respondent, "simply merging two departments and changing their names . . . won't affect food safety." Rather, "there would need to be fundamental changes at the plant inspection level to actually make a difference."

Currently, the United States is the only industrial nation to have two separate federal food safety regulatory systems. Moving forward, we'll continue to post on emerging developments.

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In the coming months, the FDA will likely begin requiring food manufacturers that obtain positive test results from product samples to report such findings to the agency. Although the new rules will likely have a significant impact on industry as adjustments are made to ensure compliance, the rules (once implemented) would likely add an additional layer of safety to our food regulatory system.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services, no later than September 27, 2008, to establish a Reportable Food Registry. The stated purpose of the amendment was “to provide a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to [better] target [its] limited inspection resources.” Implementation of the new law, along with its mandatory reporting requirements, however, has been delayed while the FDA continues to develop an effective electronic reporting system.

In its current form, the new food registry will apply to food manufacturers, and will define “reportable foods” as any article of food (other than infant formula) found to contain harmful pathogens, “for which there is a reasonable probability that the use of, or exposure to, such of food will cause serious adverse health consequences or death to humans or animals.” 21.U.S.C. 350f. If a food sample tests positive for any pathogen considered an adulterant for the particular food at issue, manufacturers would be required, within 24 hours, to submit an electronic report to the agency.

Currently, the FDA anticipates that the registry (and the associated reporting requirements) will likely go into effect sometime later this spring.  We, of course, will keep you posted.

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Tom Vilsack, Secretary of Agriculture, promised today to quickly name a new head of the USDA's Food Safety Inspection Service (“FSIS”).

The FSIS, an agency falling within the jurisdiction of the USDA, enforces the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq., by providing continuous on-site federal inspection within meat packing plants. On a daily basis, federal inspectors ensure that all meat products sold in interstate commerce are: (1) produced under sanitary conditions; (2) not adulterated; and (3) properly labeled. In addition to monitoring production, the FSIS also closely regulates meat product labeling. Over the decades, the agency’s policy making and inspection authority has expanded to oversee poultry production under the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.), and egg production under the Egg Products Inspection Act (21 U.S.C. § 1031, et seq).

Leading candidates for the position currently include: (1) Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest; and (2) former FSIS administrator Barbara J. Masters. Ms. Masters currently serves as a senior policy adviser with the Washington law firm Olsson Frank Weeda Terman Bode Matz PC.

Other names that have been considered for the position include Dr. Michael Doyle, Director of the University of Georgia Center for Food Safety (see our post below, highlighting Dr. Doyle’s work on Globalization and Food Safety), Michael Taylor, a veteran of the Food and Drug Administration and George Washington University professor, and Bill Marler, a well-known Seattle-based food-borne illness attorney.

Good luck to all.

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As we continue to comment on food safety litigation avoidance and crisis management, several food industry groups on Friday, in letters to Congress, urged House and Senate leaders to quickly enact enhanced food safety reforms.  The letters announced that, although “Americans continue to enjoy the safest food supplies in the world, . . . new challenges require Congress and the Administration to modernize our food safety net.”  In turn, industry groups urged lawmakers to move forward on the following FDA proposals, originally announced in 2007, as part of the FDA’s Food Protection Plan:

• Require Domestic Food Safety Plans:  As proposed, the initiatives would require domestic food producers to affirmatively identify potential food safety risks associated with production methods and products, identify and implement enhanced production or other controls, and prepare formalized food safety plans (for FDA review) addressing such risks;

• Require Foreign Food Safety Plans:  Adoption of the pending initiatives would also empower the FDA to assist foreign governments seeking to adopt robust food safety regulations, and require foreign food product importers to better police foreign suppliers. The initiatives would also, in part, require domestic foreign food product importers to document food safety controls being implemented by foreign suppliers, and require such records to be available for FDA review; and

• Adopt A More Robust Risk-based Approach to Inspections:  As proposed, the initiatives would also enable the FDA to increase food safety inspections for those facilities and products (both foreign and domestic) that pose, based upon science and risk-based studies, the greatest risk of potential contamination.

In addition to encouraging a more robust food safety inspection system for domestic and foreign products, the letters also urged Congress to better enhance the safety of fruits and vegetables by establishing uniform standards for high-risk products.  In addition, the letters addressed the FDA’s continuing request for mandatory recall authority, which would be available to the agency in those rare circumstances where companies refused, following FDA recommendations, to initiate recalls voluntarily.

The letters were undersigned by numerous industry organizations, including the Grocery Manufacturers Association, the Food Marketing Institute, the American Frozen Food Institute, the International Bottled Water Association, the International Dairy Foods Association, the National Fisheries Institute, the National Restaurant Association, the Retail Industry Leaders Association, the Snack Food Association and the United Fresh Produce Association.  According to Pamela Bailey, President and CEO of the Grocery Manufacturers Association, improved food safety tools would ultimately enable us to better “maintain our position of global leadership and assure consumer confidence.”

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While the USDA and FSIS work hard to protect our meat and poultry supply, the FDA works to ensure that the remaining 78 percent of domestic and imported food remains safe.

Although the FSIS maintains a continuous presence in most meat and poultry plants, the FDA typically only visits food processing facilities once a year. Following a number of highly publicized recalls, however, some began suggesting that the FDA should follow the USDA model, requiring more regulation and a more visible federal presence within FDA-regulated food processing facilities. Thus, the question was called: Would the FDA become more like the USDA?

Maybe just a little. In November 2007, the FDA unveiled a new initiative, called the "Food Protection Plan." The plan avowed three “core elements” - prevention, intervention and response - to better ensure a safer quality of food for all Americans (FDA, “Food Protection Plan: One-Year Progress Summary”). While, as part of these efforts the FDA asked Congress for additional regulatory authority, including new mandatory recall powers, most agree it would be far too impractical, expensive and imprudent to demand or even require a significant increase in domestic inspection. In June, for instance, the Government Accountability Office actually condemned the plan for “failing to provide details on the costs or specific strategies.”

In any event, within the coming months, we will see where these efforts lead. Personally, I expect the FDA’s regulatory control to grow significantly in the coming years (resulting, for instance, in the implementation of a mandated HACCP-based system for many new categories of foods). Thus, although it remains unlikely in the near term that federal inspectors will be physically “moving in” to your food production facility (as occurs in slaughter establishments), you may nevertheless find them knocking on your door more often, at the very least, to critique your HACCP plan.

Stay tuned for new developments.

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