The FDA has issued its final guidance on regulating genetically engineered (GE) animals under the new animal drug provisions of the Food, Drug and Cosmetic Act. The guidance clarifies FDA’s regulatory authority “and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.” It is intended to apply to GE animals with heritable rDNA constructs. According to the guidance, GE animals are being developed for a number of purposes, including the enhancement of production or food quality traits, improvements to animal health, the production of products for human therapeutic uses, and enhancement of animals’ interactions with humans (e.g., hypoallergenic pets). The FDA explains when GE animal producers must comply with labeling and record-keeping requirements or submit information for agency approval.
Category Archives Issue 289
Among the first official acts of the Obama administration was a directive from White House Chief of Staff Rahm Emanuel to all federal departments and agencies not to finalize any pending rule and to extend final-rule effective dates for 60 days. According to a news source, the block affects a Department of Agriculture rule that established requirements for country-of-origin labeling (COOL) on meat and other perishable foods. A regulatory analyst for a Washington-based government watchdog group reportedly observed that the freeze would “give USDA an opportunity to tighten up the rule.” Critics have apparently said that the Bush rule could weaken distinctions between U.S. and imported meats by allowing domestic facilities that process domestic and imported animals to carry a multi-country label. See Bloomberg.com, January 21, 2009.
12
