Posts By Shook, Hardy & Bacon L.L.P.

The Organic Trade Association (OTA) has announced that the United States and Canada have agreed to finalize negotiations on their organic equivalency standards before the new rule is implemented on June 30, 2009, to ensure trade continues uninterrupted. The new Organic Products Regulations will require all Canadian organic products to be endorsed by a certification body accredited by the Canadian Food Inspection Agency (CFIA). The rules were designed to create a nationwide standard for Canadian products but raised fears that products previously accepted as organic from other countries, including the United States, could be shut out if they did not comply. The U.S. final rule on national organic standards was fully implemented in October 2002 and is slightly different than the new Canadian regulation. An official of the OTA was quoted as saying, “Canadian consumers will definitely benefit from this, and will continue to enjoy quality year-round organic products from…

The Food and Drug Administration (FDA) has proposed delaying for 60 days a final rule titled “Substances Prohibited From Use in Animal Food or Feed,” which establishes “measures to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE).” Scheduled to take effect April 27, 2009, the rule includes provisions that prohibit the rendering of spinal cords and brains from cows older than 30 months. Industry groups have reportedly requested additional time to arrange for alternative disposal methods, prompting the agency to consider pushing back the implementation date to June 26. FDA will accept comments on the proposed delay until April 16, 2009. See Federal Register, April 9, 2009.

The Food and Drug Administration (FDA) has announced a public meeting slated for May 1, 2009, in College Park, Maryland, to discuss the economically motivated adulteration of foods and drugs, which the agency defines as the “fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.” FDA is seeking public input on how the food, drug, medical device, and cosmetic industries, regulatory agencies and other stakeholders “can better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health risk.” The agency will accept written or electronic comments until August 1, 2009. See Federal Register, April 6, 2009.

The Obama administration has reportedly issued a tough warning that it will substantially change the way government oversees food safety. According to published reports, food-handling practices that formerly would have resulted in mild warnings from FDA may now lead to wide-ranging and expensive recalls.“ The food industry needs to be on notice that FDA is going to be much more proactive and move things faster,” David Acheson, FDA associate commissioner for food protection, was quoted as saying. “We’re going to try to stop people from getting sick in the first place, as opposed to waiting until we have illness and death before we take action.” Meanwhile, the Centers for Disease Control and Prevention (CDC) issued a report April 9 claiming the nation’s food safety system needs a thorough overhaul and that even though cases of Salmonella may be increasing, their incidence is not statistically significant. The system should be overhauled,…

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service has amended swine health protection rules to clarify that regulations regarding the treatment of garbage consisting of industrially processed materials are subject to the same treatment requirements of other regulated garbage except for materials that meet the definition of “processed product.” The action ensures that garbage fed to swine has been treated to inactivate disease organisms that pose a risk to the U.S. swine industry. Comments must be received by June 2, 2009. See Federal Register, April 3, 2009.

The 111th Congress is now on recess until April 20, 2009, but before legislators left Washington, D.C. for their district offices, they introduced several more bills relating to food safety, nutrition or wellness. They include: H.R. 1869 – Introduced April 2, 2009, by Representative James McGovern (D-Mass.), this bill would require the president to convene a “White House Conference on Food and Nutrition.” The main focus of the bill is addressing hunger and food insecurity. It has been referred to the House Committee on Agriculture. H.R. 1897 – Introduced April 2, 2009, by Representative Earl Blumenauer (D-Ore.), this proposal would amend the Internal Revenue Code to give employers a tax credit for the costs of implementing workplace wellness programs that would have health awareness, employee engagement, behavioral change, and supportive environment components. Among the targets of the legislation are obesity and fitness. The bill, which has a companion in the…

In this publication of the Food and Drug Law Institute, Bruce Silverglade examines his belief that the Food and Drug Administration (FDA) should play a significant role in advancing President Obama’s “prevention” agenda. “The Administration should reinvigorate FDA’s nutrition mission and the agency should be instructed to develop and implement a series of initiatives that would help Americans improve their diets and protect their health,” writes Silverglade, who is director of legal affairs for the Center for Science in the Public Interest in Washington, D.C. He outlines ways the government could facilitate improvements in diet and health, including product reformulation, food labeling, universal symbols to communicate nutritional content, and food marketing to children The government, Silverglade writes, “has an important role in mitigating the toxic food environment created by the food manufacturers and restaurant chains promoting huge servings of soft drinks, snacks and ‘value’ meals that are literally penny-wise and…

University of Cincinnati College of Law Professor James O’Reilly recommends that defense lawyers begin preparing now for a reasonably predictable wave of litigation involving exposures to nano-sized materials that are being used in increasing number in a variety of foods and other products. According to O’Reilly, defense lawyers should be partnering with the health, safety and environmental professionals in key client organizations and starting to revise material safety data sheets, referring to them as important vehicles for risk disclosure and excellent defense tools. O’Reilly also suggests that counsel (i) “urge investment in engineering controls on the lines where the nanoparticles are dumped, sprayed or handled”; (ii) “encourage the medical department or industrial hygiene team to track the medical and compensation claims of lung and internal organ problems, and lost-time illnesses, that have both a base line among the worker population before nano-materials use, and a potential for a ‘spike’ increase…

Food litigator William Marler has reportedly filed the first lawsuit against CW Sprouts for a recent Salmonella Saintpaul outbreak that purportedly sickened more than 100 in Colorado, Iowa, Kansas, Nebraska, and South Dakota. Stephen Beumler of Omaha apparently claims that he ate a sandwich with the company’s alfalfa sprouts and fell ill with the Salmonella strain traced to its products. Filed in a federal court in Nebraska, the lawsuit alleges product liability, negligence and violations of implied warranties of merchantability. Beumler reportedly seeks unspecified damages and attorney’s fees. See U.S. Food Law Report, April 3, 2009.

Pilgrim’s Pride Corp. settled claims that its insurance carrier unjustifiably refused to pay a significant portion of coverage owed to the food company arising out of a Listeria outbreak. The insurance company that agreed to provide coverage to Pilgrim’s insurer for any bad faith claims successfully mounted against it has been granted a declaratory judgment of no liability. Cont’l Cas. Co. v. Ace Am. Ins. Co., No. 07-958 (S.D.N.Y., decided March 31, 2009). Apparently, Pilgrim’s insurer agreed to the essential terms of a settlement proposed by a mediator before seeking Continental’s consent to settle. Under Texas law, settlement agreements are legally enforceable when the parties have agreed on the amount of consideration to be paid and the release of claims. While Pilgrim’s insurer made minor modifications to the agreement after notifying Continental, the court found that the mediator’s proposal was a binding and enforceable settlement agreement. Because Pilgrim’s insurer did…

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