Category Archives Legislation, Regulations and Standards

The Food and Drug Administration (FDA) has proposed two new food safety rules addressing foodborne illness prevention and produce safety under the Food Safety Modernization Act. According to FDA, the first rule would require both foreign and domestic food manufacturers “to develop a formal plan for preventing their food products from causing foodborne illness” and to establish plans “for correcting any problems that arise.” The second rule proposes “enforceable safety standards for the production and harvesting of produce on farms,” including “science- and risk-based standards for the safe production and harvesting of fruits and vegetables.” Before drafting the rules, FDA apparently conducted “extensive outreach” involving the produce industry, consumers, other government agencies, and the international community. It will accept comments on both rules until May 16, 2013, and plans to issue further proposals addressing the safety and oversight of imported foods. “We know one-size-fits-all rules won’t work,” said FDA Deputy…

The Federal Trade Commission (FTC) recently adopted final amendments to the Children’s Online Privacy Protection Rule (COPPA) that aim to “strengthen kids’ privacy protections and give parents greater control over the personal information that websites and online services may collect from children under 13.” Based on the findings of a review initiated in 2010, these amendments (i) “modify the list of ‘personal information’ that cannot be collected without parental notice and consent, clarifying that this category includes geolocation information, photographs, and videos”; (ii) “offer companies a streamlined, voluntary and transparent approval process for new ways of getting parental consent”; (iii) “close a loophole that allowed kid-directed apps and websites to permit third parties to collect personal information from children through plug-ins without parental notice and consent”; (iv) “extend coverage in some of those cases so that the third parties doing the additional collection also have to comply with COPPA”; (v)…

Chicago’s City Council has reportedly approved an ordinance that will impose new nutrition rules on most food and drinks sold from 350 vending machines in 94 city buildings, setting restrictions on fat, calories, sugar, and sodium. The new ordinance applies to vending machines in city-owned and -leased buildings and takes effect January 2013. In a recent press release, Mayor Rahm Emanuel (D) said that the changes aim to encourage personal responsibility. “These new vending machines will make it easier than ever before for city employees and the public to make healthy lifestyle choices,” he said. “When city employees take their wellness into their own hands, we can reduce health care costs and also serve as a model for the residents of Chicago when it comes to making health choices.” Many health advocates have purportedly said that it makes sense to set standards for machines aimed at children and at city…

Russian health regulators have announced a new regulation that will require imported meat to undergo testing for and be certified free of ractopamine, a hormone that has reportedly been linked to health concerns. The additive allegedly promotes animal growth and leaner meat and is added to some animal feed in the United States. According to news sources, because the U.S. Department of Agriculture (USDA) has no mechanism in place certifying meat as “ractopamine free,” the Russian requirement could effectively halt U.S. pork and beef exports to the country, profoundly affecting the more than $500 million market. Some industry analysts reportedly see the move as retaliation for American legislation punishing Russian officials linked to alleged human rights violations. In a recent press release, U.S. Agriculture Secretary Tom Vilsack stated, “The United States is very concerned that Russia has taken these actions, which appear to be inconsistent with its obligations as a…

The Food and Drug Administration (FDA) has extended for five years a 2007 food safety agreement with the General Administration of Quality Supervision, Inspection, and Quarantine of China (AQSIQ) to “enhance cooperation between the U.S. and China on food and feed safety.” The agreement includes provisions enhancing FDA’s “ability to identify high-risk food products entering the United States from China,” facilitating food facility inspections, focusing on “high-risk foods,” and creating processes for FDA to “accept relevant, verified information from AQSIQ regarding registration and certification.” See CFSAN Constituent Update, December 11, 2012.

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has requested an extension of approval of an information collection associated with the regulations for the introduction of organisms and products altered or produced through genetic engineering. The regulations set forth “the permit application requirements and the notification procedures for the importation, interstate movement, or release into the environment of a regulated article and necessitate certain information and recordkeeping requirements, including APHIS issued permits, applicants’ field testing records, and the submission of protocols to ensure compliance.” APHIS is asking the Office of Management and Budget to approve its use of these information collection activities for an additional three years. The agency will consider comments received by February 11, 2013. See Federal Register, December 11, 2012.

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced that, as of February 8, 2013, it will require producers of non-intact raw beef and all ready-to-eat products containing meat and poultry to hold shipments until they pass agency testing for foodborne pathogens. FSIS announced its plan to implement this policy in April 2011. In the past, FSIS’s practice has apparently been “to allow products tested for adulterants to bear the mark of inspection, and to enter commerce, even when test results have not been received.” FSIS had asked, but not required, official establishments to maintain control of products tested for adulterants pending test results. According to FSIS, “because establishments, including official import inspection establishments, were not consistently maintaining control of product, despite FSIS’s request that they do so, adulterated product was entering commerce.” FSIS has reportedly stated that if the new requirement had been in place…

The Federal Trade Commission (FTC) has released a December 2012 staff report finding that only 20 percent of the 400 children’s mobile applications under review “contained any privacy-related disclosure on the app’s promotion page, on the developer website, or within the app.” Titled “Mobile Apps for Kids: Disclosures Still Not Making the Grade,” the report also warned that even when privacy policies were provided, they were often “long, dense and technical” or lacking in “basic details, such as what specific information about a child would be collected, the reason for collecting such information, or what parties would obtain the information.” According to FTC staff, its testing results evidently revealed that 59 percent of the 400 apps “transmitted some information from a user’s mobile device back to the developer or a third-party,” with 5 percent transmitting the device ID to developers; 56 percent transmitting the device ID to advertising networks, analytics…

The President’s Council of Advisors on Science and Technology (PCAST) has issued a report urging the federal government to launch “a coordinated effort to boost American agricultural science by increasing public investments in that economically important domain and rebalancing the U.S. Department of Agriculture’s research portfolio.” According to a press release from the Executive Office of the President, the report also calls for the creation of a network of public-private agricultural “innovation institutes” to leverage the strengths of government scientists and commercial interests. PCAST concludes that “the United States is the undisputed world leader in agricultural production today, but also cautions that U.S. agriculture also faces a number of challenges that are poised to become much more serious in the years ahead.” These challenges include (i) managing new pests, pathogens and invasive plants; (ii) increasing the efficiency of water use; (iii) reducing the environmental footprint of agriculture; (iv) adapting to a…

The Government Accountability Project (GAP) has filed a lawsuit under the Freedom of Information Act (FOIA) against the Food and Drug Administration (FDA), alleging that the agency has wrongfully withheld information requested about the use of anti-microbial drugs in food-producing animals. GAP v. FDA, No. 12-1954 (D.D.C., filed December 5, 2012). GAP requests an order requiring FDA to make the requested information available within 10 working days and further seeks costs and attorney’s fees. According to the complaint, GAP sought information in February 2011 about anti-microbial drugs collected from animal-drug sponsors under 21 U.S.C. § 360b. While FDA produced, as requested, educational and outreach materials that assist drug sponsors in fulfilling their reported duties, it withheld (i) “FDA’s data for use of anti-microbial drugs in food-producing animals in 2009 as broken down by container size, strength, and dosage form”; and (ii) “FDA’s data for use of anti-microbial drugs in food-producing…

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