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

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.

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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 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.

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

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

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

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 Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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