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

We spend more time thinking about food 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.

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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 “Legally Speaking” Blog), writes a dedicated monthly food safety column for the National Provisioner, authors regular columns for FoodSafetyTech, 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.

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It is no small secret that our collective survival depends, quite literally, on the food we eat.

The availability and affordability of food has a direct impact on our individual health, along with (if we work in the food industry) the success and longevity of our careers. Indeed, if we produce food for others, the quality of the food we market and sell also affects our individual ability to provide for and feed our families. In this regard, every one of us (no matter how large or small our role may be) has an interest in making sure that the food we produce (and, ultimately, consume) is the safest it can possibly be.

To date, we’ve done an excellent job. Nevertheless, despite our best efforts, the existence of naturally occurring pathogens in our environment – and by extension in many foods – remains a real part of our business and lives. Given the limitations of science and, in no small part, consumer behavior, no one is immune. Every month, for instance, approximately 6,000,000 Americans will develop some type of food-borne illness. This also means that – each year– nearly one in every four Americans will be affected. Of these, approximately 325,000 individuals will be hospitalized, and nearly 5,000 could die.

And, no matter how much we care about food safety, this trend is not only likely to continue, but will likely accelerate. Given recent and substantial improvements in national food-borne illness outbreak surveillance, more food-borne illnesses are being identified, and more outbreaks are being reported. By extension, these outbreaks are being associated with an increasing number of foods, and more companies are – either directly or indirectly – being affected.

This resulting increase in reported outbreaks, along with a corresponding increase in media coverage, has also affected public and governmental interest in food safety. The politics of food safety, of course, translates exponentially into more regulation and a significant increase in food litigation. Thus, if your company has not yet faced a food-borne illness claim, chances are in the short term it will. Additionally, for this reason, businesses should begin contemplating how to best position themselves (from both a food safety and liability standpoint) to anticipate future problems, reduce company exposure, and react appropriately when an alleged food-borne illness or outbreak does indeed occur.

Not all food-borne illnesses claims, however, have merit. As noted, as a direct result of the growing public and political awareness in food safety, we have also witnessed an explosion in food-borne illness and outbreak litigation. In turn, we also know that, because of limited resources and other reasons, some outbreak investigations are still unable to identify the real culprit, and some continue to identify the wrong source. In these and other cases, many claimants (and their attorneys) continue to sue the wrong party.

Thus, here too, it is critical that food companies understand how food-borne illnesses are tracked, identified and confirmed, what to expect in a food-borne illness investigation, how to respond during an outbreak or recall, how to react when confronted with a potential claim, and how to properly defend their business and reputation when lawsuits are ultimately filed.

In any event, this is why we are proud to offer our Advance Series on Managing Food-borne Illness Outbreaks and Claims. For nearly a decade, our food safety team has helped food companies across the nation prevent litigation, manage crisis and defend claims (both meritorious and non-meritorious allegations). In the coming weeks and months, this series will provide additional and timely insight on what food companies can do to anticipate risk and reduce potential exposure, to effectively respond to and manage food-borne illness outbreaks and claims, and to effectively defend food-borne illness litigation and lawsuits when they do, indeed, occur.

Although we enjoy one of the most plentiful, affordable and safest food supplies in the world, we also live in one of the most litigious societies. Thus, despite the fact that food-borne pathogens are (and likely always will be) an inherent part of our food supply, and despite the fact that individual risk can be greatly reduced through responsible consumer behavior, many individuals will continue to be affected by food-borne illness and, unfortunately, regardless of source or cause, many will continue to sue.

In recognition of the incredible efforts hard working Americans to provide safe and affordable food to our families, we feel inclined, when lawsuits overreach, to protect and defend yours.

Again, thanks for a job well done. And, welcome to www.foodsafetycounsel.com.

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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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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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I affectionately call him Buck Magnum.  You may know him by some other name.    Whatever his true identity, I would like to thank him for a job well-done.  

Buck’s story begins over one hundred years ago.  At the turn of the Century, we began shipping more and more food products between states.  Due to the emergence of rapid transportation, improved preservation techniques and the ability of media to reach additional consumers, food became more plentiful, affordable and accessible.  For the first time, food processors could viably ship perishable products anywhere in the nation.

While interstate shipments grew, however, food safety regulations became inadequate.  Industrial advances quickly outpaced limited state and local regulations.  In the meat industry, laws defining what constituted “adulteration” or “misbranding” were determined, if at all, by each individual state. Moreover, what was forbidden in one state was lawful in another.  This hodgepodge of inconsistent laws soon made it apparent that, without a national approach to food safety, a single set of rules, and a single agency to enforce them (enter Buck Magnum), American citizens could have no confidence in the origins or safety of their food. 

The federal approach to food safety was solidified in 1906, when Congress passed the Wholesome Meat Act and the Pure Food and Drugs Act.  These Acts (along with their successors) formed the framework for the national food safety policy that continues this day. The 1906 Wholesome Meat Act (now known as the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq.) requires continuous federal inspection in meat packing plants, often times by multiple inspectors, to ensure that meat products are safe and wholesome, not adulterated and marked with the federal legend of inspection verifying the same.  

Today, the federal statutory and regulatory scheme is enforced by the Food Safety Inspection Service (a sub-agency of the USDA), via inspectors such as Buck.  In turn, I have watched quietly over the years as this picture has become, in some sense, legendary.  I have seen the photograph countless times on the internet, and have referenced it in publications, speeches and Powerpoints.  I even have a copy sitting next to the plant on my desk. 

Thus, if you know the true identity of this food safety icon, and can privately express our thanks, we'd be grateful.  Alternatively, if you could land me an autograph, you’d make my day.

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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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