According to a news source, U.S. Food and Drug Administration (FDA) personnel have experienced significant delays in obtaining visas from China to staff food and drug inspection offices in that country. One staff member reportedly withdrew his application after waiting nine months for approval to work in China. The delays are seen as a setback for the agency’s efforts to improve supply chain safety; FDA planned to use $10 million in additional appropriations to increase its food inspection staff from two to nine and its drug inspection unit from just one to 11. FDA currently has three offices in the country—in Beijing, Shanghai and Guangzhou—staffed with eight U.S. civil servants and five Chinese nationals. An FDA spokesperson said, “We believe that timely issuance of visas for FDA staff will be beneficial to both the U.S. and China, and that it’s in China’s best interest to issue these visas and move…
Category Archives Issue 495
The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a proposed rule that would amend the National List of Allowed and Prohibited Substances to permit the use of biodegradable biobased mulch film in organic crop production and the use of Citrus hystrix and curry leaves in organic processing. NOP has also proposed removing two nonorganic agricultural products from the National List—hops (Humulus lupulus) and unmodified rich starch—“as their use exemptions expired on January 1, 2013, and June 21, 2009, respectively.” According to NOP, biodegradable biobased mulch film is a synthetic substance “used as an alternative to petroleum-based plastic mulches that do not biodegrade,” while the leaves and fruit of Citrus hystrix are traditional ingredients in Lao, Thai and other Southeast Asian cuisines, and curry or sweet neem leaves are an important ingredient in Indian, Sri Lankan, Malay, and other Southeast Asian cuisines. The agency will accept comments on…
The Food and Drug Administration (FDA) has apparently filed a petition submitted by the Dean Foods Co. and the WhiteWave Foods Co. “proposing that the food additive regulations be amended to provide for the expanded safe uses of vitamin D2 and vitamin D3 as nutrient supplements in food.” In particular, the petition seeks to amend (i) 21 C.F.R. 172.39 “to provide for the safe use of vitamin D2 as a nutrient supplement in edible plant-based food products intended for use as alternatives to milk and milk products,” and (ii) 21 C.F.R. 172.80 “to provide for the safe use of vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted.” FDA has also noted that because the action will not have any significant effect on the human environment, there is no need to undertake an environmental assessment or prepare an environmental impact statement. See Federal Register,…
The Food and Drug Administration (FDA) has apparently signaled its intent to proceed with an experimental study of consumer responses to nutrient content claims on fortified foods by issuing a notice of the proposed collection of information to the Office of Management and Budget. First announced in the August 15, 2012, Federal Register, the study would involve 7,500 adults asked to complete a 15-minute web-based survey designed to gauge their responses “to expressed and implied nutrient content claims on the labels of snack foods such as cookies, carbonated beverages, and candy.” “The study is a part of the Agency’s continuing effort to enable consumers to make informed dietary choices and construct healthful diets,” concludes FDA, which has estimated the total burden of this information collection at 3,099 hours. “Results of the study will be used primarily to inform the Agency’s understanding of how claims on the packages of fortified food…
The Food and Drug Administration (FDA) has announced plans to prepare an environment impact statement (EIS) for a proposed rule that would establish standards for the growing, harvesting, packing, and holding of produce for human consumption. According to an August 16, 2013, FDA press release, the agency determined that an EIS was necessary based on public feedback and its own analysis, and will now begin a scoping process “designed to determine relevant issues that will influence the scope of the environmental analysis.” FDA will accept comments on the EIS scoping process until November 15, 2013. Additional details about the proposed produce standards appear in Issue 466 of this Update. See Federal Register, August 19, 2013.
The Food and Drug Administration (FDA) has announced an upcoming public meeting slated for September 19-20, 2013, in Washington, D.C., to discuss regulations proposed under the Food Safety Modernization Act (FSMA) that would establish Food Supplier Verification Programs as well as new rules for accrediting third-party auditors and certification bodies. Intended to ensure “that imported food meets the same safety standards as food produced domestically,” the proposed rules would (i) require importers “to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by [FMSA],” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies currently rely.” FDA will accept advanced registrations from individuals who wish to participate in person by September 10, 2013. Additional details about the proposed rules appear in Issue 492 of this Update. See Federal Register, August 16, 2013.
The Federal Trade Commission (FTC) has issued a request for comments concerning a proposed parental consent method submitted by AssertID, Inc. under the Voluntary Commission Approval Processes provision of the Children’s Online Privacy Protection Rule. Amended December 19, 2012, and effective July 1, 2013, the Children’s Online Privacy Protection Rule requires certain websites to post privacy policies and obtain verifiable parental consent before collecting, using or disclosing personal information from children younger than age 13 and provides approved methods for obtaining the consent. Interested parties may, however, submit requests for commission approval of additional consent methods. Regarding AssertID, Inc.’s proposal, the commission seeks comment on the following questions: (i) is this method already covered by existing methods listed in Section 312.5(b)(1) of the rule; (ii) does the proposed method meet the requirements for parental consent laid out in 16 C.F.R. § 312.5(b)(1)—is it reasonably calculated to ensure that the person…
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