Category Archives Legislation, Regulations and Standards

Due to the recent government shutdown, the U.S. Food and Drug Administration (FDA) has extended the public comment period for several proposed rules related to the implementation of the Food Safety Modernization Act (FSMA). FDA has extended the deadline for comments on (i) “Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” until March 15, 2014; and (ii) “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” and “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,”  until January 27.    

The U.S. Food and Drug Administration (FDA) has issued the “Second BiennialReport to Congress on the Food Emergency Response Network (FERN)” as required under Section 202(b) of the Food Safety Modernization Act. Administered by FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), “FERN is an integrated, secure laboratory system for federal, state, and local government agencies engaged in food safety and food defense activities” responsible for detecting, identifying and responding to situations involving “biological, chemical, or radiological contamination of food.” Among other successes, FDA reports that FERN “has been vital in responding to major outbreaks of foodborne disease attributed to many products, including spinach, pet food, and peanut butter.” The network has also provided surge capacity for federal and state responses to both natural and industrial emergencies, in addition to handling large-scale, non-emergency projects, such as arsenic testing in fruit juices and rice products, and…

U.S. Sens. Richard Blumenthal (D-Conn.), Dick Durbin (D-Ill.), John Rockefeller (D-W.V.), and Edward Markey (D-Mass.) have written a letter to Rockstar, Inc. CEO Russell Weiner, questioning the energy drink company’s relationship with Ronin Syndicate, the manufacturer of remote-controlled toys crossed-branded with the Rockstar logo. Responding to consumer complaints on social media sites, the senators pointed to a July 31, 2013, hearing held by the Commerce, Science, and Transportation Committee investigating the alleged health risks of caffeinated energy drinks. In particular, they noted that Rockstar Chief Operating and Financial Officer Janet Weiner told committee members that “Rockstar’s target demographic is persons 18 to 35 years of age and their company does not market products to children under 12 years of age.” “Despite statements from your company that Rockstar, Inc. does not market to children, examples of what appear to be targeted marketing of your products to children have come to our attention,”…

U.S. Sen. Edward Markey (D-Mass.) and U.S. Rep. Joe Barton (R-Texas) have reportedly introduced joint legislation (S. 1700 and H.R. 3481) that would expand the Children’s Online Privacy Protection Act of 1998 (COPPA) to cover children older than age 12 and establish new rules for collecting, storing and disclosing their personal information. Titled the Do Not Track Kids Act of 2013, the initiative includes provisions that “would extend protection to teens ages 13 to 15 by prohibiting Internet companies from collecting personal and location information from teens without their consent and would create an ‘eraser button’ so parents and children could eliminate publicly available personal information content, when technologically feasible.” According to Markey, who in September 2013 asked the Federal Trade Commission to investigate Facebook’s decision to change its privacy settings for teens, the legislation seeks to draw congressional attention to “the speed with which Facebook is pushing teens to…

“A curious hurdle is threatening to complicate efforts by the United States to reach a major trade agreement with 11 Pacific nations by the end of the year: catfish,” reports New York Times writer Ron Nixon in a November 13, 2013, article describing how the U.S. Department of Agriculture’s (USDA’s) new catfish inspection program has angered Vietnam, a member of the TransPacific Partnership and a major exporter of a catfish known as pangasius. Vietnamese trade officials have apparently written to Secretary of State John Kerry, the White House and Congress, criticizing the new inspection program as a trade barrier in disguise. “And it’s not even a good disguise; it’s clearly a thinly veiled attempt designed to keep out fish from countries like Vietnam,” Le Chi Dzung, the chief economic officer of the Vietnamese Embassy in Washington, D.C., told the Times. Intended to replace the Food and Drug Administration’s (FDA’s) catfish…

In response to the U.S. Food and Drug Administration’s request for comments on its “Draft Guidance for Industry on Arsenic in Apple Juice: Action Level,” the Center for Food Safety (CFS) has asked the agency to “limit the public’s exposure to arsenic through a new regulatory strategy that recognizes the prevalence of arsenic in the food supply.” Stating that although individual foods containing arsenic may be safe to eat in moderation, CFS maintains that they are often consumed in combination, thereby presenting a risk of “cumulative arsenic exposure” that could reach dangerous levels. Calling FDA’s draft guidance “insufficient” to address these health hazards, CFS’s November 12, 2013, letter to FDA asks for the agency to regulate based on “cumulative arsenic exposure” rather than through product specific levels. According to CFS, FDA “must do more” to adequately protect public health. To that end, CFS suggests that, because arsenic is present in…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice of intent “to list emissions from high-temperature unrefined rapeseed oil as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986” (Prop. 65). The proposal is based on the 2010 cancer identification by the International Agency for Research on Cancer (IARC) for “emissions created by frying food in unrefined rapeseed oil [commonly known as canola oil] heated past its boiling point.” IARC apparently found that these emissions “cause increased incidence of malignant tumors in female rats and combined malignant and benign tumors in both sexes of the mouse.” Comments are requested by December 16, 2013. See OEHHA News Release, November 15, 2013.  

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued the tentative agenda for the December 5, 2013, meeting of its Carcinogen Identification Committee, which identifies chemicals for addition to the Proposition 65 list when they have been “clearly shown, through scientifically valid testing according to generally accepted principles, to cause cancer.” Under consideration will be butyl benzyl phthalate, a chemical used in food conveyor belts, and diisononyl phthalate, a plasticizer used in food-contact materials. The meeting will be webcast. See OEHHA News Release, November 14, 2013.  

Legislation (H.B. 660) in Maine that would require food manufacturers to label products containing genetically modified (GM) ingredients is reportedly in jeopardy after New Hampshire lawmakers voted 12-8 against a similar labeling bill. Although Maine’s law passed earlier this year with broad bipartisan support, it can take effect only if five contiguous states pass similar laws. “I was not surprised,” said the New Hampshire bill’s sponsor Maureen Mann (D-Deerfield) in a news article. Evidently, while a subcommittee that spent the summer working on the bill recommended its approval, members of New Hampshire’s House Environment and Agriculture Committee expressed reservations about the measure, citing difficulties with enforcement because food labeling is a federal matter. According to sources, unlike in Maine, the vote in New Hampshire broke along party lines, with Republican committee members largely opposing it. Democrats have a 42-vote majority in the New Hampshire House, while Republicans have a two-seat…

The European Food Safety Authority (EFSA) has issued a statement finding that a published review of observational studies ultimately failed to establish a causal relationship between high intakes of phosphate additives in food and increased cardiovascular risk in the general population. In addition to considering the data on the association between serum phosphate levels and cardiovascular disease, the review in question apparently proposed a mechanism by which the metabolism of inorganic phosphate could contribute to vascular calcification, in the process suggesting that “intake of phosphate as a food additive, especially through consumption of processed and ready-to-eat food, is of particular concern.” Additional details about the review, which was initially published in the January 2012 edition of Deutsches Ärzteblatt International, appear in Issue 428 of this Update. After assessing these findings at the request of the European Commission, EFSA concluded that (i) the limitations of the observational studies included in the…

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