According to the most recent quarterly report released by Stericycle ExpertRECALL Index, food recalls increased over 50 percent in the fourth quarter of 2011 and almost 55 percent over the same quarter in 2010. Half of the fourth quarter recalls were Class I, and another 40 percent were Class II. Allergen concerns remained the primary cause of the food recalls, making up over 100 recalls announced by FDA, while the second leading cause was potential Listeria contamination. Potential Salmonella contamination was the third leading factor in initiating recalls, representing 18 recalls. In contrast, medical device recalls decreased by more than 60 percent and pharmaceutical recalls declined by 35 percent in the same quarter.
You can access the full Fourth Quarter 2011 Recall Index here:
http://www.expertrecall.com/wp-content/uploads/Quarter-Four-ExpertRECALL-Index.pdf
Or to view the fourth quarter food recall report summary, use the following link:
http://www.expertrecall.com/wp-content/uploads/Quarter-Four-ExpertRECALL-Index-Food.pdf
These statistics are consistent with a recent analysis of Reportable Food Registry reports, which showed undeclared allergens as one of the top reasons for such reports. They underscore the importance of supply chain management for allergens, ensuring your labeling is compliant, and instituting CGMPs to avoid allergen contamination on shared product lines or in shared facilities. Our food industry specialists regularly assist in reviewing and advising on food safety programs, labeling, and supply chain risk management. Please contact Sarah Brew for more information.
Do you manufacture goods, including food or agricultural goods, that are sold in California, or sell such goods in California? If so, you should be aware of a recent state law requiring disclosure of certain information about your supply chain. 
On January 1, 2012, the California Transparency in Supply Chains Act of 2010 went into effect. The Act requires any retail seller or manufacturer that does business in California and has annual worldwide gross receipts that exceed one hundred million dollars ($100,000,000) to disclose its efforts to eradicate slavery and human trafficking from the company’s direct supply chain for tangible goods offered to sale. Cal. Civ. Code § 1714.43(a)(1). The Act is likely to cover many large non-California retailers and manufacturers, even if these companies ’ activities and operations within California are relatively minor.
Under the Act, each covered company must disclose at minimum whether, and to what extent, the company does each of the following:
- Verifies product supply chains to evaluate and address risks of human trafficking and slavery;
- Conducts audits of suppliers to evaluate supplier compliance with company standards for trafficking and slavery in supply chains;
- Requires direct suppliers to certify that materials incorporated into the product comply with the laws regarding slavery and human trafficking of the country or countries in which they are doing business;
- Maintains internal accountability standards and procedures for employees or contractors failing to meet company standards regarding slavery and trafficking; and
- Provides company employees and management, who have direct responsibility for supply chain management, training on human trafficking and slavery, particularly with respect to mitigating risks within the supply chains of products.
These required disclosures must be made available on the company’s website with a “conspicuous and easily understood link” to the disclosure on the homepage. Cal. Civ. Code § 1714.43(b). Any retail seller or manufacturer that has not already done so should determine whether they are covered by the Act and make the requisite disclosures on their website if they are.
If you have any questions or concerns with this act, we urge you to contact your legal advisor. Kristin Eads, a partner in Faegre Baker Daniel’s Food Litigation & Regulatory practice, is also available to assist clients.
On January 23, 2012, the U.S. Supreme Court unanimously struck down a California law that bans the processing of all non-ambulatory livestock. The California statute, enacted in 2008, would have required the immediate euthanasia of non-ambulatory animals, including hogs, at the slaughterhouse.
The National Meat Association (NMA) challenged the state law before the U.S. District Court in California. The lawsuit was later appealed to the U.S. Supreme Court on the argument that the Federal Meat Inspection Act (FMIA) preempts California law. The high court agreed with NMA in a ruling that the FMIA expressly preempts the application of this law to federally inspected slaughterhouses. National Meat Association v. Harris, No. 10-224.
Faegre Baker Daniels attorney Lance W. Lange filed an amicus brief for the American Association of Swine Veterinarians, the National Pork Producers Council and the National Farmers Union in the Harris case. Read more.
Faegre Baker Daniels agribusiness litigator, Mark Carpenter, attended the recent 2012 International Dairy Foods Association (IDFA) Dairy Forum. Mark heads up the firm’s dairy segment within its Food & Agriculture Industry Group. This event was attended by industry leaders including many business representatives from major dairy companies. The firm is an active member of IDFA and was one of the sponsors of the Forum.
Feeding the growing world population was a central topic of the conference. Former U.S. Secretary of Agriculture Dan Glickman stressed the need for more public investment in research and development in the food sector. With much of the population growth in the coming decades expected to occur in China and India, Anil Gupta and Haiyan Wang of the China India Institute spoke about “Getting China and India Right,” a presentation discussing the business climate in those two countries, with positive and negative examples in the recent past from U.S. businesses who have attempted to establish a presence in China or India.
The conference also took a close look at sustainability issues, particularly the need to produce more dairy products for a larger population without using substantially more land or water. The closely related subject of consumer acceptance of production-increasing technology was addressed during multiple panels.
The Food and Drug Law Institute’s (“FLDI”) annual Food Week Conference is being held in Washington, D.C. on January 23-26, 2012. Sarah Brew will be leading a panel on Managing Outbreaks and Recalls, on Day 2 of the conference, January 25th.
Dr. David Acheson, Leavitt Partners, is also speaking on a panel addressing – FSMA: How Key Provisions Affect the Future of the Food Industry.
For 15% off of registration, use the discount code: FOODPRTNR
FDLI’s annual Food Week is a unique opportunity for food law and regulation professionals. This comprehensive conference will provide practical guidance and an educational forum on the latest legal and regulatory developments affecting all sectors of the food industry and go to the core of what food safety experts, food engineers, food law practitioners and food manufacturers do every day. Food Week 2012 consists of three days of advanced programming: advertising and labeling, food safety and global issues, as well as FDLI’s industry standard “Introduction to Food Law and Regulation” course.
Hope to see you there!
National Feed and Grain Association has learned that FDA is planning to issue four separate sets of proposed regulations on the one-year anniversary of President Obama’s signing into law the Food Safety Modernization Act (FSMA). Those four regulations are:
(1) Preventive controls for human food
(2) Preventive controls for feed, feed ingredients, and pet food
(3) Foreign Supplier Verification Program (FSVP)
(4) Regulations requiring produce growers to implement preventive controls and product tracing systems for certain types of produce
FDA is also expected to release a “fact sheet” for each of the proposed regulations summarizing the major requirements, as well as schedule public meetings to provide opportunity for comment. Full article from NGFA.
Faegre Baker Daniels and FaegreBD Consulting will provide more analysis and guidance on the proposed rules later this week.
Arleen Nand and Breia Schleuss recently attended the National Grain and Feed Association’s 40th Annual Country Elevator Conference & Trade Show in Chicago. The firm is an active member of the association and was a sponsor of the event that recorded the second highest attendance ever at over 700 people. Among those attending were representatives from AgriBank, Bank of America, Bank of the West, CoBank, JPMorgan, MetLife Investments and Wells Fargo. In response to the volatile commodities market and the bankruptcy of MF Global, several speakers at the conference focused on how lenders could provide their borrowers with the opportunity to increase or “right size” their credit facilities to meet urgent margin calls while using “accordions” to minimize usage fees. Accordion features permit a borrower to request an increase to a credit facility on an expedited (and often paperless) basis while not incurring usage fees until an accordion increase is exercised. Although lenders are not required to grant a borrower’s request, the accordion features provide a structure for responding to rapid market changes and the need for increased liquidity. Arleen and Breia are lawyers in Faegre’s finance and restructuring group and are focused on agricultural finance.
By David Acheson, Leavitt Partners
As many in the food industry continue to ponder exactly what will be required of them from the new preventive control regulations due out in 2012 the FDA is giving us a glimpse of where they are heading. In its ongoing efforts to be transparent and involve stakeholders in the creation and implementation of the mandates of the Food Safety Modernization Act, FDA published a new presentation, “Focus on Prevention/FDA Food Safety Modernization Act” in November. Focused on its current thinking on preventive controls and relevance within the wording and standards of FSMA, the presentation discussed the four main themes of FSMA as: Prevention; Partnerships; Import Safety; and Inspections, Compliance and Response. Read more.
As food safety management and consumer claims continue to be of high interest throughout the food industry, Sarah Brew will be presenting on a panel ”Assessing the Food Safety Modernization Act’s Impact on Your Litigation Paper Trail: Knowing What to Document, When and How” at the American Conference Institute’s 5th National Forum on Food-Borne Illness Litigation, on November 30, in Chicago. Her co-panelists will be John Batz, director of regulatory affairs at Malt-O-Meal, and Nick White, general counsel at JBS USA Holdings, Inc.
Kristin Eads will also be a speaker the following day, December 1, at the related American Conference Institute’s Advanced Summit on Defending Food & Beverage Consumer Fraud Litigation, also in Chicago. She will be joined by panelists Lori Marco, vice president of external affairs and general counsel at Hormel Foods Corporation, and John Min, counsel at Kellogg Company, to address the topic of “Effective Defenses to Deceptive Packaging and Labeling-Based Claims.”
Please watch our blog for key takeaways and insights from these conferences.
Faegre & Benson recently assisted its client, a dietary supplement manufacturer, and the client’s California counsel in obtaining dismissal of a punitive class action complaint, which alleged the manufacturer had made unsubstantiated claims on the labels of one of its dietary supplements. The manufacturer client moved to dismiss the claim against it for failure to state a claim based upon there being no private right of action for unsubstantiated advertising under California law. The Court agreed, dismissing all of the Plaintiff’s claims without prejudice. A copy of the Order is available here.