The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a press release on Wednesday, December 5, 2012, announcing that companies producing raw ground chicken and turkey and similar products will be required to reassess their sanitation procedures and pathogen control plans over the next few months. Specifically, over the next 90 days, producers of raw ground chicken and turkey must conduct a thorough examination of its current Hazard Analysis and Critical Control Points (HACCP) to confirm its ability to identify hazards and better prevent foodborne illness. After the 90 day period, FSIS inspection program personnel will begin verifying that establishments that manufacture raw ground turkey or chicken products have indeed reassessed their HACCP plans.
FSIS will be documenting whether establishments made any changes to their HACCP plans in response to the required reassessment and will later evaluate those changes. Later, the agency intends to publish guidance materials for the industry on best practices to reduce Salmonella in ground and comminuted (further processed by mechanical separation or deboning and chopped, flaked, minced or broken down) poultry.
In making this announcement, officials at FSIS are hoping to lower the prevalence of Salmonella contamination within these types of products. This attention to the ground poultry product industry with a focus on Salmonella comes as a response to recent outbreaks that have sickened hundreds across the country in the past few years. Just in the last two years there have been two major Salmonella outbreaks associated with ground poultry products that affected consumers nationwide.
In conducting these reassessments, FSIS is advising companies to look at, among other things, the following:
[E]stablishments should evaluate the adequacy of their sanitation procedures for processing equipment, including grinders, blenders, pipes, and other components and surfaces in contact with the product. Thus, Sanitation SOPs, other prerequisite programs, or HACCP plans should address procedures that ensure that all slaughter and further processing equipment, employee hands, tools, and clothing, and food contact surfaces are maintained in a sanitary manner to minimize the potential for cross contamination within and among lots of production. In addition, FSIS expects establishments to ensure that slaughter and dressing procedures are designed to prevent contamination to the maximum extent possible. Such procedures should, at a minimum, be designed to limit the exterior contamination of birds before exsanguination, as well as minimize digestive tract content spillage during dressing process.
Other FSIS recommendations include validating cooking instructions, examining lotting practices that minimize contact between lots, and requiring suppliers to show that they have used a Salmonella intervention step.
In FSIS’s notice, the agency also announced that it will be expanding the Salmonella verification sampling program to include other raw comminuted poultry products, in addition to ground product; it will be increasing the sample size for laboratory analysis from 25 grams to 325 grams to provide consistency as the Agency moves toward analyzing samples for Salmonella and Campylobacter; and it will be conducting sampling to determine the prevalence of Salmonella in raw comminuted poultry products.
Although these new procedures are intended for producers of ground or comminuted chicken and turkey products, FSIS is recommending that manufacturers of comminuted products derived from cattle, hogs, and sheep or comminuted poultry products derived from poultry other than chicken or turkeys also consider assessing whether their food safety systems present food safety vulnerabilities.
Products Liability Law360 ran a piece this week entitled “Suits Over Deceptive Food Marketing Likely To Increase” (unfortunately, this is a subscription-only site) authored by Liz McKenzie. The article discusses rightly how increased FDA enforcement action may lead plaintiffs attorneys to file “piggy-back” putative class actions. For example, it took just 13 days following the FDA’s warning letter to General Mills concerning Cheerios for the first putative class suit to be filed.
Compounding increased FDA enforcement, recent rulings from the Supreme Court and the Third Circuit, like the Snapple Decision, have made it more difficult to assert a preemption defense in food cases in the absence of formal FDA rulemaking.
But, what one hand giveth the other taketh away. The hope for food companies is that that the Supreme Court’s recent decisions in Twombly and Iqbal will negate the preemption decisions and effectively heighten the bar for consumer fraud claims related to product marketing. Dismissal for failure to meet the new “plausibility” pleading standard and not preemption is exactly how the District Court ruled in Wright v. General Mills. Wright involved a putative class complaint involving Nature’s Valley products sold as “100% Natural” “even though the products contained one or more non-natural or artificial ingredients such as high-fructose corn syrup (’HFCS’).”
In Wright, the court found defective, under the Iqbal/Twombly “plausibility” standard, the plaintiffs’ injury-in-fact allegation. The Wright court ruled that the injury-in-fact allegation “conclusory,” “sparse” and “defective.” The plaintiff alleged only that “Defendant caused Plaintiff and other members of the Class to purchase, purchase more of, or pay more for, these Nature Valley products.”
Following the Supreme Court's new standard of notice pleading and its application in the Wright case, query how any putative consumer fraud class complaint can survive a Rule 12 motion without having first completed market surveys or gathering of other evidence of consumer injury.
Recently, I’ve received several requests for resources explaining the anatomy of a food-borne illness claim. In other words, what events can be expected, and when? What can or should a company (in particular the legal department) do in response to a claim?
Part I – Notice of an Outbreak (and Possible Claims)
First off, don’t panic. Your company’s crisis management team (which has been well-rehearsed for this scenario) should convene action upon the first notice of a possible outbreak—even before verification and before claims are apparent. Food safety experts should contact the health departments that may have identified the outbreak. Together with the legal, sales and quality assurance departments, your food safety experts should be involved in a full investigation of the possible outbreak. The earlier the intervention, the greater the possibility of collecting key information that may be useful in determining whether your company is linked to the outbreak and pinpointing other possible sources of the outbreak. Public relations experts should also be consulted at the first possible moment.
Checklist for the legal department:
- Log events, actions and communications. This is critical for responding to government agencies and to claims.
- Record all reported injuries. Collecting information about potential claims early is a key to mitigating those claims and future legal costs.
- Notify insurers. Insurance companies require prompt notice; insurers may also have assets available for crisis response.
- Document the investigation. Litigation may be protracted, and a well-documented investigation may be key to the company’s defense.
- Institute a litigation “hold” on the destruction of any company documents or emails. Don’t turn a bad situation into a nightmare; spoliation claims can take on a life of their own.
- Retain product samples for future testing. This may be critical to support experts’ opinions at trial and to preserve claims against suppliers.
- Review and retain vendor/supplier documents. Recovery against suppliers could be as important as or more important than insurance recovery.
- Assess the merits of a consumer hotline. It could be helpful in disseminating accurate information to consumers (inaccurate or conflicting information can lead to litigation) and in collecting information about the pool of potential plaintiffs.
- Assess the merits of a consumer/vendor reimbursement program. Like having a consumer hotline, providing immediate reimbursement could help dampen the volume of future plaintiffs.
Stay tuned for Part II – Receipt of the Demand Letter.