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.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

So, here we go again.

Thinking about food rather than eating it. But, that's okay.

Because helping food companies address complex USDA and FDA regulations, to respond to NOIEs, Warning Letters and 483s, to better protect the future of their brand, to reduce their risk of liability and exposure, to respond to outbreaks and recalls (when they do occur), or to prove decisively that an alleged food safety claim lacks all merit, is well worth the small sacrifice of delaying a meal.

For over a decade, we have worked closely with food industry clients responding to all of their most pressing food safety needs. And, now, we look forward to working with you.

Welcome to www.foodsafetycounsel.com.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Our food safety lawyers work with food companies nationwide, helping them comply with complex food safety regulations, decrease their food safety risk, prevent unwanted litigation, manage recalls exceptionally quickly and defend high profile foodborne illness claims -- when they do occur. 

Over the last decade, the firm has assisted food companies throughout the country on a wide-range of food safety matters involving regulatory compliance, crisis planning and management, and outbreak litigation.

During this period, the firm has defended food industry clients against high-profile foodborne illness outbreak claims in more than 2o states throughout the country (including Arizona, Arkansas, Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Wisconsin). These have included outbreaks and claims involving a wide-range of foodborne pathogens, including E. coli O157:H7, Campylobacter, Clostridium Perfringens, Norovirus, Salmonella and Staphylococcus.  The firm's food safety team also assists clients with crisis management and other issues in advance of and following major food product recalls.

Shawn K. Stevens, a member of the firm's food safety team, is one of the only lawyers in America who dedicates his practice entirely to representing the food industry. 

Mr. Stevens counsels food industry clients throughout the country (including some of the nation’s largest food producers, national restaurant chains, and several food distributors and grocers) on a wide-range of food safety regulatory and liability issues.  Mr. Stevens works closely with clients to identify and appropriately manage risk, plan and prepare for possible crises, and also respond to governmental enforcement actions and recalls.  Mr. Stevens also defends industry clients against high-profile foodborne illness outbreaks and claims. Mr. Stevens has additional, wide ranging experience counseling clients in commercial, insurance and medical malpractice disputes.

In addition to his legal practice, Mr. Stevens also speaks regularly to national and international audiences on issues relating to food safety, regulatory compliance, crisis management, and foodborne illness outbreaks, recalls and lawsuits.  Mr. Stevens also serves as a weekly contributor to Meatingplace (as the author of its newest “Legally Speaking” Blog), writes a dedicated monthly food safety column for the National Provisioner, and is a regular contributor to Food Quality Magazine.

Mr. Stevens has also been recognized by his peers as a Wisconsin Super Lawyer Rising Star, and was recently selected as one of Milwaukee's 2011 "Forty Under 40." 

Ralph A. Weber, Ralph A. Weber has represented clients in several of Wisconsin’s highest profile lawsuits over the past several decades, and currently litigates for one of the world’s largest companies in food safety cases throughout the United States. His trial experience includes many lengthy jury and court trials. His appellate experience includes multiple oral arguments before the Wisconsin Supreme Court and intermediate appellate courts.

The prestigious international lawyer reference, Chambers Guide-USA, identifies Mr. Weber as a top commercial litigator. He also has been recognized by his peers through selection to Best Lawyers in America, Wisconsin Super Lawyers, and has been selected one of the Best of The U. S.’s list of “Best of Class” service providers in the United States.

An Adjunct Professor at Marquette University Law School, he taught Trial Advocacy for 15 years, and created a jury research and courtroom facility, the Trial Science Institute. In addition to speaking about litigation subjects, Mr. Weber co-edited a best selling book, Dear Americans: Letters from the Desk of Ronald Reagan (Doubleday, 2003).

Mr. Weber served on the Law Review at Columbia University Law School, graduating in 1982, and then served as a Law Clerk for the Hon. Richard D. Cudahy, United States Court of Appeals for the Seventh Circuit. He graduated summa cum laude from Marquette University in 1978.
 

Amelia L. McCarthy, a member of the firm, specializes in general commercial, health care, food and product liability litigation.

She also currently serves as a Municipal Prosecutor for a Wisconsin community and has served as a Public Service Special Prosecutor for the Dane County and Milwaukee County District Attorney's offices. 

Throughout the course of her career, Ms. McCarthy has tried over 50 court and jury trials. She also successfully defended four class action lawsuits, obtaining three dismissals with prejudice and one nuisance value settlement without having to proceed through class certification.

Ms. McCarthy has been recognized by her peers through selection to Wisconsin Super Lawyers and was recently named one of Milwaukee's Top "40 under 40" business leaders.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to the Center for Science in the Public Interest (CSPI), Hawaii ranks among the top states for food-borne illness surveillance, investigation and reporting. Other leading states include Maine, Kansas, Wyoming, Vermont, Alaska and North Dakota. Minnesota and Oregon are also regarded as having strong surveillance systems as well.

While many states ranked very high, however, some problems do remain.

According to CSPI, “some states may not have enough investigators or the money to train and equip their staff, which can lead to lower-quality investigations.” In addition to affecting the quality of such investigations, these and other limitations can also lead to mistaken conclusions regarding the source or cause of an outbreak.

CSPI also reports, however, the FDA Food Safety Modernization Act, which passed in the House of Representatives and is now pending in the Senate, will likely help improve national surveillance capabilities. If passed, the Act would require FDA to improve coordination between federal, state and local surveillance systems; develop a national network of laboratories; and improve epidemiological tools available to the states. The bill would also integrate food-borne illness surveillance with other bio-surveillance capabilities

Thus, as we strive to improve the safety of our food, as well as the ability of our food safety system to accurately detect and resolve emerging problems, we send our congratulations to the hard-working professionals in Hawaii and other states who are leading the way.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link