We Think We Have An Adequate Food Safety Plan, But How Will It Be Enforced?

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.
 

The New Food Safety Modernization Act: What IS a Food Safety Plan?

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;
  1. Determine Critical Control Points: Identify appropriate critical control points (“CCPs”) where a control measure can be applied to prevent or reduce an identified hazard;
  1. 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.
  1. Establish Monitoring Procedures: Monitor each CCP continuously in order to identify and immediately address any deviations from the critical limits which may occur; 
  1. 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;   
  1. Establish Verification Procedures: Test and critique the HACCP plan, once designed (and periodically thereafter), to verify that the HACCP plan is working correctly;
  1. 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.

The Food Safety Modernization Act: FDA's Six Month "Progress Report"

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.
 

FDA Continues Work On Rules Governing Preventative Controls

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.
 

What Does The New Food Safety Modernization Act Mean To Your Business?

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.

FDA's Food Safety Modernization Act Will Soon Become Law

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.
 

Clarification Creates Confusion: Final Comments Received On FSIS' Preliminary Validation Guidance

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.

On The Road In Kansas: Beef Producers Committed To Food Safety

BY Guest Blogger James Marsden

About a year after the 1993 Jack-in-the-Box E. coli O157:H7 outbreak, I moved from the AMI Foundation in Washington, DC to KSU in Manhattan, Kansas to join their beef safety research group. Some of the first people I met in Kansas were Lee Borck, Kenny Knight and Andrew Murphy, three beef producers and co-founders of The Beef Marketing Group (BMG), www.beefmarketinggroup.com.

We had discussions then about pre-harvest food safety and its importance in an integrated food safety system for control of E. coli O157:H7. At a time when very little was being done in this segment, BMG initiated a comprehensive program called “Progressive Beef” that included HACCP at beef feedlots, quality systems, domestic source verification and a plan to address animal handling and welfare. They also implemented a Natural Beef program in which hormones and antibiotics are never administered, no animal byproducts are used in feed and cattle are sourced and age verified from birth.

Recently, I visited one the BMG feedlots near Great Bend, KS and reviewed the food safety and animal welfare programs that had been put in place over the past several years. HACCP is strictly voluntary for beef producers, but BMG’s HACCP system is as well designed and comprehensive as if were a regulatory requirement. There are also extensive animal handling systems and training for BMG employees and drivers who transport cattle. The animal identification and traceability systems are amongst the best in the industry.

All of this was impressive, but what I found to be most notable, was that all of the work and capital that were required to achieve these remarkable results happened because of BMG’s vision and commitment to food safety, sustainability and animal welfare. None of it was required by federal regulations.

At the time BMG made these commitments, considerable investments were required and there was no assurance that they would ever be recovered. As it turned out, there are plenty of customers who like the safety and quality elements of the BMG systems, including Natural Beef and are willing to pay a premium to get them.

For years, the beef industry has had to operate in a world in which the retail value of beef products didn’t allow for profitability between all sectors. The BMG systems add value to beef and that added value supports profitability for beef producers, packers and retailers.

The founders of the Beef Marketing Group decided to produce products that meet consumer expectations. The result is one of the most successful beef production companies in the world.