This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- Cucumber salmonella outbreak kills two, sickens hundreds. As of September 22, 3 people are known to have died and more than 550 have fallen ill in 33 states in an outbreak of salmonella linked to cucumbers imported from Mexico. More than half the cases have occurred in people under 18 years of age. The Centers for Disease Control and Prevention, which is investigating the outbreak along with the FDA, says the affected cucumbers were distributed by Andrew & Williamson Fresh Produce, which has since issued a recall. On September 16, the FDA announced it had identified the farm that is the source of the outbreak: Rancho Don Juanito de R.L. de C.V. in Baja state. At least 8 lawsuits have been filed against Andrew & Williamson, in Minnesota, California, Utah and Arizona.
- 28 years. Stewart Parnell of the now-defunct Peanut Corporation of America has been sentenced to 28 years in prison for knowingly selling salmonella-tainted peanut products. His actions resulted in a massive nationwide salmonella outbreak in 2008 and 2009 linked to the deaths of 9 people and hundreds of illnesses, and led to one of the largest food recalls in US history. Prosecutors had sought life in prison for the 61-year-old Parnell, who was convicted of more than 70 criminal charges last year, including obstruction of justice, selling adulterated food, knowingly shipping tainted food across state lines, conspiracy and wire fraud. Peanut broker Michael Parnell, Stewart's brother, was sentenced to 20 years in prison, and quality control manager Mary Wilkerson was sentenced to 5 years. These sentences are the harshest ever handed down in a food safety case. All three are planning to appeal. See our earlier coverage of this story here.
- New York City imposes warning label on sodium in restaurant menu items. On September 9, the New York City Board of Health voted to require chain restaurants in that city to place a warning symbol next to menu items that contain at least a full day's worth of sodium. Michael Jacobson, president of the Center for Science in the Public Interest, said he hopes New York City's move will lead to similar initiatives by public health authorities around the nation and might induce the FDA to issue its long-awaited voluntary sodium-reduction targets. The new requirement takes effect on December 1 and applies to all restaurant chains with at least 15 locations in the city. The warning will take the form of a salt shaker icon in a black triangle. Some health experts say the warning could reduce heart disease by making consumers more aware of what they are eating.
- Cheesemakers express concern over FDA's possible action concerning raw-milk cheese. Politico reported on September 14 that manufacturers of raw milk cheeses have begun an informal dialogue with the FDA over its announcement that it is assessing the potential health risks of raw milk cheeses. Cheese producers say that raw milk brings a more intense taste and richer texture to cheese and that raw milk cheese does not present the same health issues as does raw milk itself. The FDA has noted a few cases in which raw milk cheese has resulted in illnesses. As part of its assessment, the FDA has established a 90-day comment period on the issue of raw milk cheese that ends in early November.
- Judge declines to certify class action on PopCorners chip labeling. The Northern District of California has declined to certify a class of consumers in a lawsuit that alleges New York-based Medora Snacks falsely used the term "all natural" on its labels for PopCorners chips. The plaintiffs had noted that the corn-based chips are made with genetically engineered corn. However, the packaging was changed to remove the "all natural" claim in late 2013, before the lawsuit was filed. On August 18, the court ruled there was no evidence of concrete legal harm to the plaintiffs and no reason to believe that they would be wronged again in the future.
- Food safety modernization funding remains uncertain after Senate hearing. After a hearing of the Senate Appropriations Committee's agriculture subcommittee on September 16, supporters of the Food Safety Modernization Act (FSMA) said they were not sure how the agency will obtain the funds it says it needs to implement the law. Michael Taylor, the FDA's deputy director for foods and veterinary medicine, told reporters that if Congress does not fully fund the law, "something significant will have to give, whether it's in whole program areas, simply delaying or disrupting, or just doing everything inadequately." Senator Jerry Moran (R-KS), the chairman of the subcommittee, said at the hearing, "This Subcommittee remains committed to investing in FSMA's implementation within the resources at its disposal and has done so since FSMA's enactment in 2011. As we continue this year's appropriations process, FSMA funding will undoubtedly play a significant role in our deliberations."
- Food industry groups advocate against new FSMA user fees to fund FDA activities. On August 26, a coalition of more than 60 food industry groups sent an open letter to Health and Human Services Secretary Sylvia Mathews Burwell and Office of Management and Budget Director Shaun Donovan urging that any additional FDA funding to support the FSMA come from the regular Congressional budget rather than from new user fees on the industry. The coalition, led by the American Frozen Food Institute, says in its August 26 letter that the Obama Administration's fiscal 2016 budget for the FDA included a proposal to impose a "food facility registration and inspection fee" to fund activities related to the FSMA – but that, as in several prior years, Congress rejected such fees. The letter states, "As consumers continue to cope with a period of prolonged economic recovery and food makers and retailers struggle with fluctuating commodity prices, the creation of new food taxes or regulatory fees would mean higher costs for food makers and lead to higher retail food prices for the most vulnerable consumers."
- FDA publishes rules for food safety under modernization act. On August 31, the FDA published in the Federal Register a broad set of regulations intended to protect people and animals from foodborne illnesses. The rules, which are mandated by the FSMA, require food manufacturers to implement preventive controls to minimize the risk of contaminating food when it's manufactured, processed, packed or held by a facility. The FDA was forced by a court order to finalize the rules by August 30 after the Center for Food Safety took legal action against it. The center argued that the FDA had violated the FSMA and the Administrative Procedures Act by failing to issue the required regulations by statutory deadlines. The agency has until October 31 to issue both its final standards for produce safety and a final rule to create a foreign supplier verification program, both under the FSMA
- Prison sentence in dietary supplements case. On September 9, Barry Steinlight, owner of Raw Deal, a manufacturer of dietary supplements, was sentenced to 40 months in federal prison, to be followed by 12 months of supervised release, on one wire fraud count. Steinlight admitted to adulterating products sold by his company, Raw Deal, with such fillers as rice flour and maltodextrin and to creating false certificates of analysis about the contents of his products, as well as false certificates of authenticity that passed off his products as kosher. Steinlight will also forfeit $1 million to the federal government.
- Minimum wage hike. As Mark Bittman recently noted in the New York Times, to a large extent the push for the $15 minimum wage is about food service workers – the second largest group of employees in the US. In recent months, several US cities have passed a variety of incremental wage hikes. On September 11, New York became the first state to set its minimum wage at $15 an hour for fast-food workers in large chains, phasing in the increase over three years in New York City and over six years elsewhere.
- Neocotinoid pesticide approval struck down. On September 11, the Ninth Circuit Court of Appeals struck down the EPA's approval of the pesticide sulfoxaflor, saying the agency failed to obtain necessary, additional tests before approving it. Sulfoxaflor is a neonicotinoid, a class of insecticides that has been extensively used on crops including soybeans, strawberries, potatoes and citrus. It has been linked to honeybee colony collapse. It was approved in 2013, and that same year a group of beekeepers brought suit, calling on the EPA to rescind the registration. This decision is the outcome of that case.
- GM trends around the world. Business, jurisdictions and organizations around the world are pondering the issue of genetically modified foods. Here are some of the latest developments.
Mandatory GM nutritional labeling in the EU: In recent weeks, Scotland and Germany have joined the more than 60 countries worldwide with mandatory GM labelling laws. More than 60 countries have already passed laws requiring mandatory labeling of foods with GMO content. These countries include China, Japan, Brazil, Switzerland, Australia and nearly 30 other EU states.
European Union member states move against GM maize. Early in 2015, the EU changed its rules on the cultivation of GM crops to allow member states to opt out of growing EU-authorized GM crops. As Reuters reports, when an EU member state requests to be excluded from growing an authorized crop, the request also must be submitted to the company that applied to grow the crop. In August, Latvia and Greece chose to opt out of growing Monsanto's MON810, the only GM corn grown in the EU. France, Germany, Hungary and Austria are among the EU states that already have opted out of growing MON810. Then in September, France announced it will ask the European Commission to exclude its national territory from the release of a total of 9 GM maize varieties already authorized or awaiting authorization by the EU. GM crops are a small fragment of Monsanto's business, and the company said it has no immediate plans to request approvals for any other GM seeds in Europe.
The leading US manufacturer of spices and herbs, McCormick & Co., announced on September 8 that in 2016 it expects more than 70 percent of its herbs, spices and extracts to bear the non-GM label and that it will greatly expand its organic offerings. The company, which noted that most of its products are already sourced from plants that are not genetically engineered, is currently shipping a vanilla extract bearing a non-GM label.
The court fight over Vermont's labeling law continues. In September, attorneys general from eight US states joined four environmental groups to file amicus briefs in support of Vermont's GM labeling law. Four food manufacturers associations – the Grocery Manufacturers Association, the Snack Food Association, the International Dairy Foods Association – are appealing a US District Court decision that upheld the Vermont law. Arguments are expected in the case this fall.
California's Environmental Protection Agency in September became the first US regulatory entity to list glyphosate, the herbicide most widely used on GM crops, as a human carcinogen. California Proposition 65 requires the state to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. The agency is accepting public comments on the move until October 5.
The New England Journal of Medicine, in late August, noted its concern that "the vast majority of the corn and soybeans grown in the United States are now genetically engineered. Foods produced from GM crops have become ubiquitous." Citing the "sharp increases in the amounts and numbers of chemical herbicides applied to GM crops" and the classification by the World Health Organization's International Agency for Research on Cancer of the herbicide glyphosate as a "probable human carcinogen," the prestigious journal concluded, "We believe the time has come to revisit the United States' reluctance to label GM foods."
Meanwhile in Congress, this summer, the House of Representatives passed the Safe and Accurate Food Labeling Act of 2014, 275-150, which would prohibit individual states and counties from enacting more stringent GM labeling laws – it would pre-empt the Vermont mandatory labeling law, for instance – replacing such laws with a voluntary GM-free certification program to be overseen by the USDA. Now the battle has moved to the Senate, where an equivalent measure is expected to be taken up this fall. On September 8, the New York Times reported extensively on the vast sums of money those for and against the measure are already spending simply to enlist the support of academics in "a lobbying campaign that has transformed ivory tower elites into powerful players. The use by both sides of third-party scientists, and their supposedly unbiased research, helps explain why the American public is often confused as it processes the conflicting information."