Category Archives U.S. Government and Regulatory Agencies

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 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…

The Food and Drug Administration (FDA) has issued final rules amending food additive regulations pertaining to the use of ionizing radiation in the production, processing and handling of meat and poultry products. Promulgated at the request of the U.S. Department of Agriculture, the rules took effect on November 30, 2012. FDA requests written objections or requests for a hearing by December 31. The meat-product irradiation amendment would “provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life.” The poultry-irradiation amendment would “increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used…

The Food and Drug Administration (FDA) has proposed revoking “the standards of identity for artificially sweetened jelly, preserves and jam,” concluding that these standards “are both obsolete and unnecessary in light of [] regulations for food named by use of a nutrient content claim and a standardized term.” Responding to a citizen petition submitted by the International Jelly and Preserve Association (IJPA), the proposed rule notes that standards implemented in 1959 for fruit spreads containing nonnutritive sweeteners (NNSs) only provided for the use of saccharin, sodium saccharin, calcium saccharin, or any combination thereof (21 CFR 150.140 and 150.160). These standards did not include other NNSs approved for food use since 1959, although FDA later established under the Federal Food, Drug and Cosmetic Act a general standard of identity for foods named by a nutrient content claim such as “low calorie” or “sugar free” “in conjunction with a standardized food term,”…

The Food and Drug Administration (FDA) has issued a proposed rule that would update tolerances “for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style.” According to FDA, the regulations describing how to set animal drug tolerances for human food are not uniform, do not provide all relevant information, and “no longer accurately reflect current regulatory science.” “For example, the regulations provide the ADI [acceptable daily intake] and safe concentrations for some, but not all, drugs,” states the proposed rule. “In addition, the regulations list some tolerances as being for ‘negligible’ residue, and others as ‘no residue,’ ‘zero’ or ‘not required,’ but they do not explain what these important terms mean. The proposed rule addresses these inconsistencies by simplifying and standardizing the determination standards and codification style and by adding definitions for key terms.” FDA will accept…

U.S. Rep. Edward Markey (D-Mass.) has written a November 30, 2012, letter to Federal Trade Commission (FTC) Chair Jon Leibowitz asking the agency to investigate advertising claims made by energy-drink manufacturers. Alarmed by recent media reports allegedly linking products such as 5-Hour Energy® to consumer deaths, Markey notes that many energy drinks “are sold as dietary supplements” that do not fall under Food and Drug Administration (FDA) rules for caffeine content or labeling, and do not require FDA approval before going on the market. “As you know, the FTC has in the past successfully investigated and took action against claims made by alcohol-containing energy drinks found to be engaging in unsafe, deceptive marketing claims,” writes Markey, who has also asked FTC to describe its coordination with FDA and other federal agencies. “I believe an investigation into energy drinks that do not contain alcohol and are often targeted at children may…

Organic growers and food safety advocates, including the National Organic Coalition (NOC), have condemned recommendations contained in the final report of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21), a group appointed by the U.S. Department of Agriculture (USDA) to address transgenic contamination of organic and non-genetically engineered (GE) crops. GE crops make up the majority of corn and soybeans produced in the United States. According to news sources, of particular concern in the report is the recommendation that organic and non-GE conventional farmers pay to self-insure themselves against unwanted GE contamination. In a press release NOC stated that “This proposal allows USDA and the agricultural biotechnology industry to abdicate responsibility for preventing GE contamination while making the victims of GE pollution pay for damages resulting from transgenic contamination.” “The AC21 report takes responsibility for GE contamination prevention out of the hands of USDA and the biotech industry…

The Humane Society of the United States (HSUS) has filed a complaint with the U.S. Department of Agriculture’s (USDA’s) Inspector General requesting an investigation into the use of pork checkoff funds. HSUS contends that “federal pork checkoff program monies are being used to fund the NPPC’s [National Pork Producers Council’s] Pork Alliance program, which is the council’s state and federal lobbying operation. Further, the NPPC publicly lists the [National] Pork Board on its website among the high donor ‘partners’ of its Alliance program, a public endorsement that would also violate the Pork Board’s prohibition against involvement in lobbying activity.” The federal pork checkoff program apparently requires pork producers to pay into a fund overseen by the National Pork Board, which HSUS claims “is to use the funds for ‘promotion, research, and consumer information plans and projects’ or for the Board’s own administrative expenses. However, both federal law and USDA regulations…

The Food and Drug Administration (FDA) has suspended operations at nut and seed spread manufacturer Sunland Inc.’s New Mexico plant after investigators reportedly discovered Salmonella-tainted peanut butter linked to an outbreak that has allegedly sickened 41 people in 20 states this year. According to FDA, “the fact that peanut butter made by the company has been linked to an outbreak . . . coupled with Sunland’s history of violations led [the agency] to make the decision to suspend the company’s registration.” In a November 26, 2012, letter to Sunland’s president, FDA Commissioner Margaret Hamburg said evidence the agency collected in response to the outbreak demonstrated that “[n]ut butter and nut products manufactured, processed, packed, and held by your facility are contaminated with salmonella, or are at risk for contamination with salmonella, based on the conditions in your facility. Your facility’s testing records over the past 3 years include multiple positive…

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