Category Archives Legislation, Regulations and Standards

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has announced three public meetings for stakeholders to offer input on a new framework for animal disease traceability. Specific details for a proposed animal disease traceability rule will be discussed on May 11, 2010, in Kansas City, Missouri, May 13 in Riverdale, Maryland, and May 17 in Denver, Colorado. Written comments will be accepted until May 31. Additional meetings will be announced in a future Federal Register notice. See Federal Register, May 5, 2010.

The Food and Drug Administration (FDA) has issued an advance notice of proposed rulemaking (ANPRM) under the Sanitary Food Transportation Act of 2005 that establishes guidance on reducing the risk of food contamination during transport. The ANPRM is the first step in creating new federal regulations to govern sanitary practices by shippers, carriers by motor or rail vehicles, receivers, and others engaged in the transportation of food products for human and animal consumption. FDA has requested input from the food and transportation industries, consumer organizations and other parties on topics, including (i) whether and how information is shared among those involved, (ii) whether trucks used for transporting food should also be used for “nonfood products,” (iii) what reasons might waive “any and all” foreseeable rules intended to prevent contamination, and (iv) data on the risk of foodborne illness associated with the transportation of food. After evaluating responses to the notice,…

Featuring colorful graphics purporting to hawk products ranging from sugar-sweetened cereals and acne medication to sporting goods and meals sold at fast-food restaurants, a new website created by the Federal Trade Commission’s (FTC’s) Bureau of Consumer Protection seeks to provide children with the tools they need to properly understand and assess commercial speech. Designed for children in grades four through six, the interactive game with accompanying classroom materials urges children to keep three questions in mind whenever and wherever they are exposed to advertising: Who is responsible for the ad? What is the ad really saying? What does the ad want me to do? FTC announced the website’s launch in late April 2010, and bureau director David Vladeck said that its goal is “to help kids start to understand the commercial world they live in and to be alert to, and think critically, of advertising.” Vladeck reportedly confessed that he…

With a new working definition of “nanomaterials,” the Environmental Protection Agency (EPA) is apparently poised to launch new regulatory policies including those addressing the registration of pesticides under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA). The definition, revealed during a PowerPoint® presentation at an April 29, 2010, Pesticide Program Dialogue Committee meeting, is as follows: “An ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.” The pesticide registration policy, expected to be published in the Federal Register in June, would allow EPA to use section 6(a)(2) of FIFRA, which “requires pesticide product registrants to submit adverse effects information about their products,” to gather information about the use of nanoscale materials in pesticides. Registrants would be required to report the inclusion of nanoscale materials in a pesticide product already registered or pending registration. Under another new policy,…

Representative Rick Boucher (D-Va.) has released a draft bill that would address online privacy by regulating how web publishers and advertisers can collect and use personal information, such as name, address, Social Security number, and bank accounts, as well as implicit information, such as “click-stream.” While advertisers do not apparently dispute provisions that protect traditional personal information, they are concerned about the types of information they have been using in recent years to target ads relevant to users’ online viewing habits. The draft legislation includes as “covered information” “Any unique persistent identifier, such as a customer number, unique pseudonym or user alias, Internet Protocol address, or other unique identifier, where such identifier is used to collect, store, or identify information about a specific individual or a computer, device, or software application owned or used by a particular user or that is otherwise associated with a particular user.” Advertisers would not…

Bipartisan House sponsors of a bill (H.R. 5209) that would establish a comprehensive national approach to addressing obesity in the United States held a press conference  to unveil the measure on May 5, 2010. Appearing with Representatives Ron Kind (D-Wis.), Mary Bono Mack (R-Cal.), Earl Blumenauer (D-Ore.), and Marcia Fudge (D-Ohio) to introduce the Healthy Communities through Helping to Offer Incentives and Choices to Everyone in Society Act of 2010 (Healthy CHOICES Act) were representatives from Del Monte Foods, the Grocery Manufacturers Association, American Heart Association, and the YMCA. Referred to several House committees, the bill would authorize an array of grants, take steps to improve child nutrition, improve access to physical activity for adults and children, improve access to nutritional information and healthy foods, change transportation policies to promote healthy lifestyles, and establish research and assessment tools. Meanwhile, Senators Mark Udall (D-Colo.) and Al Franken (D-Minn.) have introduced a bill…

The Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held a hearing on May 6, 2010, to consider food safety reports prepared by the Government and Accountability Office (GAO) and the Inspector General of the Department of Health and Human Services (HHS). Both the GAO report and testimony from an Inspector General administrator focused on Food and Drug Administration (FDA) and other agency weaknesses in ensuring that imported foods are safe and domestic food facilities are subject to meaningful inspection in terms of frequency and breadth. According to Subcommittee Chair Bart Stupak (D-Mich.), the hearing marked the 12th conducted since January 2007 to consider food contamination issues. He concluded his remarks by stating, “We are fortunate that today’s hearing was prompted by the HHS and GAO reports rather than another widespread food contamination outbreak like we saw with spinach in 2007, peppers in 2008 and peanut butter…

Described by the media as “landmark” and “extraordinary,” the President’s Cancer Panel newly issued 2008-2009 Annual Report claims that the National Cancer Program has not adequately addressed the “true burden of environmentally induced cancer.” According to the panel’s transmittal letter, some 80,000 chemicals are on the market in the United States, and Americans are exposed daily to many of them, even before birth. Particularly noted were exposures to chemicals such as bisphenol A (BPA), formaldehyde and benzene. The report examines the impact of environmental exposures on cancer risk, identifies the barriers to understanding and reducing the exposures and makes recommendations to overcome these barriers. Noting that 41 percent of Americans will be diagnosed with cancer and 21 percent will die from the disease, the panel of Bush administration appointees maintains that inadequate attention and funding have been provided to the environmental causes of cancer. The panel also criticizes the scientific…

A federal court in Colorado has dismissed as premature a medical provider’s challenge to Food and Drug Administration (FDA) regulations potentially applicable to its medical procedures because the agency had issued only a warning letter against it, and warning letters are not final. Regenerative Sciences, Inc. v. FDA, No. 09-411 (D. Colo., decided March 26, 2010). The court’s analysis of the non-final nature of FDA warning letters may have some relevance in those consumer fraud actions against food makers citing such letters to establish a fact or using them as definitive evidence of wrongdoing or a violation of the law. The agency itself acknowledged that its warning letters do not constitute a determination that a particular statute or regulation applies to the specific circumstances that led FDA to issue the letters, noting “this is a factual issue that cannot be resolved until FDA brings an action against” the letter recipient.

Oral argument in litigation over whether the U.S. Department of Agriculture (USDA) properly deregulated a genetically engineered (GE) alfalfa seed took place before the U.S. Supreme Court on April 27, 2010. Monsanto Co. v. Geertson Seed Farms, No. 09-475 (U.S.). The Ninth Circuit imposed a ban on use of the GE seed until the USDA completes an environmental impact statement that accounts for potential contamination of conventional alfalfa crops. While several justices questioned the appellate court’s authority to fully ban the product’s sale, Justice Antonin Scalia contended that GE crop planting “doesn’t even destroy the current plantings of non-genetically engineered alfalfa. This is not the end of the world. It really isn’t. The most it does is make it difficult for those farmers who want to cater to the European market, which will not accept genetically engineered alfalfa.” According to press reports, environmentalists and agribusiness, watching the case closely, filed…

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