The Legal Angle On General Mills Recall Of 10 Million Pounds Of Flour
On May 31, General Mills issued a voluntary recall (http://www.generalmills.com/flour/) of more than 10 million pounds of flour. Between mid-December 2015 and early May 2016, thirty-eight people have been affected with a strain of E. Coli in 20 states, but no deaths have been reported. Some of the consumers are believed to have consumed raw dough or batter. (Serious scowl at my three daughters). General Mills has reported that “To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility, and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.” It issued the recall voluntarily “out of an abundance of caution.”
Voluntary Recalls vs. Recalls Ordered by the Food and Drug Administration’s (FDA)
Recalls may be conducted voluntarily by a manufacturer or by FDA mandate.
FDA’s mandatory food recall authority went into effect when the FDA Food Safety Modernization Act of 2011 (FSMA) was enacted on January 4, 2011. Section 423 of the FD&C Act, as added by Section 206 of FSMA, gives FDA the authority to order a responsible party to recall an article of food where FDA determines that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act [21 U.S.C. § 342] or misbranded under section 403(w) of the FD&C Act [21 U.S.C. § 343(w)] and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).
Before FSMA was enacted, FDA relied on responsible parties to voluntarily recall violative food products (except infant formula recalls, which are described under section 412 of the FD&C Act). FDA continues to rely on responsible parties to voluntarily recall violative food products; however, FSMA’s mandatory recall authority allows FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met. FDA can use its mandatory recall authority when FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act and/or misbranded under section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or exposure to such food would cause SAHCODHA.
What are the criteria for a mandatory recall?
A couple of conditions must exist before FDA can use its mandatory recall authority under section 423 of the FD&C Act.
First, FDA has to make the determination that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.
Second, FDA has to make a determination that there is a reasonable probability that the use of or exposure to such food will cause SAHCODHA.
The FDA is investigating the E. Coli outbreak along with the Centers for Disease Control (CDC). Recalls fall into three categories: Read here.
Class I High Risk Recalls involve the reasonable probability of serious adverse health consequences or death. An example of a Class I recall involved an investigation of an outbreak of listeriosis resulting in a recall of vegetable products. Read here.
Class II Less Serious Risk Recalls involve situations where exposure to the product may cause temporary or medically reversible health consequences.
Class III Low Risk Recalls involve situations where exposure to the product is unlikely to cause any adverse health consequences.
The General Mills recall is Class II, as are the vast majority of all recalls.
What Not to Do–The Peanut Corporation of America
In late 2008 and early 2009, there was an outbreak of salmonella at the Peanut Corporation of America (PCA). PCA’s peanuts were widely distributed in almost 4,000 products including various brands of peanut butter, cookies, candy, snacks, ice cream and even dog treats. Nine people died and more than 700 people experienced food poisoning after eating products with the tainted peanuts. Criminal investigations revealed that PCA executives had ignored and lied about numerous test results showing salmonella contamination at their plants. The President and CEO of PCA was sentenced to 28 years in prison. Read here.
Be Prepared – Have a Plan Before You Need one
Food manufacturers should have a recall procedures manual that includes a checklist of internal procedures, the chain of command, the division of responsibilities between departments, and points of contact for internal and external communications. A company can squander years of good will in a matter of days if it isn’t prepared to handle a recall event.
Paying the Clean Up Costs
Depending on the product, food manufacturers may be looking to suppliers to defend them and indemnify them if the suppliers are the source of the tainted product. Food manufacturers may also look to their insurance carriers depending upon the scope and nature of the recall, third party claims and the specific language of their insurance policies.
Wendel Rosen’s Food & Beverage attorneys have extensive experience counseling food manufacturers in assessing potential recall risks, indemnification rights and obligations, insurance coverage, and preparing recall procedures manuals. Wendel Rosen’s attorneys can also assist food manufacturers facing a potential voluntary or mandatory recall.