Category Archives U.S. Government and Regulatory Agencies

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has extended until March 3, 2010, the comment period for a draft environmental impact statement (EIS) for genetically modified (GM) alfalfa. APHIS made an EIS available on January 12, 2010, after the Ninth Circuit Court of Appeals ruled that the agency violated the National Environmental Protection Act by failing to prepare an EIS in connection with its recommendation to deregulate the crop. See Federal Register, February 24, 2010.

The U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) will hold a second meeting to discuss current product tracing systems for food intended for humans and animals. The March 10, 2010, meeting in Washington, D.C., specifically welcomes input on procedures for suppliers of source material used to produce raw ground beef products that test positive for E. coli. Issue 326 of this Update announced a similar meeting by FSIS and the Food and Drug Administration held in December 2009 that was designed to stimulate ideas on improving the agencies’ ability to “increase the speed and accuracy of the traceback investigations and traceforward operations.” See USDA website, February 22, 2010.

The Food and Drug Administration (FDA) has announced a plan to address preventive controls aimed at reducing the risk of microbial contamination of fresh produce at farms and packing houses. The agency seeks information and public input so that it can develop safety standards and cooperative strategies to ensure compliance. FDA is requesting comments on topics including (i) standards for domestic and foreign growers and packers; (ii) identification and prioritization of risk factors; (iii) environmental hazard assessments and “possible pathways of contamination”; (iv) methods to tailor preventive controls to particular hazards and conditions affecting an operation and to the scale of the operation; (v) microbial testing; (vi) post-harvest operations; and (vii) records and other documentation that would be useful to industry and regulators in ensuring the safety of fresh produce. Comments must be submitted by May 24, 2010. See Federal Register, February 23, 2010.

The Global Organization for EPA and DHA Omega-3 Fatty Acids (GOED) has apparently sought clarification from the Federal Trade Commission (FTC) about the letters sent to 11 companies that promote omega-3 fatty acid supplements as a benefit for children’s visual and mental development. According to GOED, FTC was not clear about whether it was concerned with claims on products containing short-chain omega-3 fatty acid (ALA) or long-chain omega-3 fatty acids (EPA and DHA). The organization also questioned FTC about the types of scientific studies that would be required to substantiate the claims. FTC reportedly told GOED that “claims about an effect (e.g. brain development) need to be substantiated by science on that effect (e.g. brain development)” and that the scientific evidence in support of a claim must be based on research conducted in the age specified in the claim. “That is, if the claim is specific to toddlers two years and…

U.S. Senator Barbara Boxer (D-Calif.) has reportedly joined the California Poultry Federation (CPF) and the Center for Science in the Public Interest (CSPI) in urging the U.S. Department of Agriculture (USDA) to reform labeling requirements for sodium-enhanced chicken. “Unfortunately, since 2003, chicken injected with sodium additives has been allowed to be misleadingly labeled as ‘100 percent all-natural,’” Boxer apparently stated at a February 24, 2010, press conference. “In these difficult times, our families should not have to pay $2 billion for saltwater that they don’t know about, they don’t want and they certainly don’t need.” Known as “plumping,” this practice purportedly involves injecting “saltwater, chicken stock, seaweed extract or some combination thereof into chicken to increase its weight and price, while simultaneously increasing sodium content by up to 700 [percent],” according to one CPF member’s internet campaign. Although USDA already requires poultry containing these ingredients to carry warning labels at…

The Federal Trade Commission (FTC) recently announced that it had sent warning letters to 11 companies that promote omega-3 fatty acid dietary supplements. The letters indicated that the companies should review their product labeling and packaging claims, as well as product advertising, to ensure that the claims are adequately substantiated. The commission’s issuance of these letters is significant because of the FTC’s action to regulate dietary supplement labeling claims, an area that has for nearly four decades been regulated by the Food and Drug Administration (FDA). Commission Takes Aim at Ad Links Between Omega 3 and Children’s Visual and Mental Development According to a February 16, 2010, press release, [FN 1] the FTC’s Division of Advertising Practices in January sent warning letters to 11 companies that promote supplement products containing omega-3 fatty acids intended for use by children ages 2 years and older. The letters reference an investigation the FTC conducted…

A federal court in Washington has reportedly denied a feedlot company’s request to invalidate or delay implementation of the country-of-origin labeling (COOL) regulations adopted by the U.S. Department of Agriculture (USDA) in 2008. Easterday Ranches, Inc. v. USDA, No. __ (E.D. Wash., decided February 5, 2010). According to news sources, the company argued that the COOL regulations, which do not allow beef imported from Canada or Mexico and slaughtered in the United States to be labeled as a U.S. product, conflicted with U.S. Treasury Department rules, would raise its recordkeeping and operational costs, and deter packers from paying fair prices for Canadian cattle. The Treasury rules apparently provide that beef is deemed a U.S. product if it undergoes “substantial transformation,” e.g., slaughter, within this country. The court refused to postpone USDA’s rules and further declined to order the agency to create an exception to COOL allowing cattle imported from Canada and…

The Food and Drug Administration (FDA) has published a notice seeking public comments on its proposed collection of information on foods derived from new plant varieties including those created through biotechnology. Comments must be submitted by April 19, 2010. The types of information that developers of new plant varieties would be required to provide to the agency include (i) a description of the applications or uses of the bioengineered food, (ii) information about the sources, identities and functions of the introduced genetic material, (iii) information about any known or suspected allergenicity and toxicity, and (iv) information relevant to the safety and nutritional assessment of the bioengineered food. Commenters are asked to address whether the proposed collection “is necessary for the proper performance of FDA’s functions,” the accuracy of the agency’s estimate of the burden of the proposed information collection, ways to improve the quality of the information to be collected,…

The Food and Drug Administration (FDA) has submitted a proposed collection of information involving antimicrobial animal drugs to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. According to the Federal Register notice, a 2008 amendment to the Federal Food, Drug, and Cosmetic Act requires that “the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals.” The first report under the law will be due March 31, 2010, and must specify (i) “The amount of each antimicrobial active ingredient by container size, strength, and dosage form”; (ii) “quantities distributed domestically and quantities exported”; and (iii) “a listing of the target animals, indications, and production classes that are specified on the approved label of the…

The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have issued a joint statement to announce a collaborative effort to improve the safety and quality of fresh produce. As part of the announcement, the agencies report that USDA’s Agricultural Marketing Service “is in the midst of evaluating a proposed marketing agreement for the leafy green industry,” while the FDA “is currently developing a proposed produce safety regulation.” The notice calls for feedback and comments from stakeholders, noting that FDA would establish “a docket to receive information about current practices and conditions for the production and packing of fresh produce and practical approaches to improving produce safety.” See FDA News & Events, February 18, 2010.

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