The U.S. Environmental Protection Agency (EPA) has issued working guidance on its Section 8(a) Information Gathering Rule on Nanomaterials in Commerce for the agency’s Final Nanotechnology Reporting and Record-Keeping Requirements Rule, which became effective August 14, 2017. The rule has been modified to eliminate: (i) exemptions for nanoclays, zinc oxide, nanocellulose and naturally occurring nanomaterials from reporting requirements; (ii) volume cut-offs below which no reporting would be required; and (iii) an exemption for chemical substances manufactured as part of surface films. Issue 645
Category Archives Issue 645
The U.S. Food and Drug Administration (FDA) has announced the availability of industry guidance titled, “Ultrafiltered Milk in the Production of Standardized Cheese and Related Cheese Products: Guidance for Industry.” The guidance advises manufacturers that FDA intends to exercise enforcement in the use of fluid ultrafiltered milk in cheese products. Issue 645
The U.S. International Trade Commission (USITC) has found a “reasonable indication” that domestic olive production has been injured by imports of Spanish olives sold at less than fair market value. In June 2017, two California olive producers filed a petition alleging that the imported olives, which are subsidized by the Spanish government, have damaged domestic producers. According to the petition, the number of domestic olive producers has fallen from 20 to two over the last few decades. The Department of Commerce initiated an investigation in July, and final determinations of penalties or duties due under the Tariff Act of 1930 are expected in early 2018. Issue 645
The U.S. Department of Agriculture, Food and Drug Administration and the Agricultural Marketing Service will sponsor three meetings in September and October 2017 to provide information and receive comments on U.S. positions to be discussed at upcoming Codex Alimentarius Commission meetings. On September 1, the agencies will discuss U.S. positions for the Committee on Fresh Fruits and Vegetables, which meets in Uganda on October 2-6, 2017. The public meeting to discuss positions for the Committee on Food Labeling is scheduled for September 13, before the committee meets in Paraguay on October 16-20, 2017. Finally, the agencies will hold a public meeting to discuss positions for the Committee of Food Hygiene on October 11, before the committee’s meeting in Chicago on November 13-17, 2017. Issue 645
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has announced that the agency will provide guidance on menu-labeling requirements before the end of 2017 in advance of the May 2018 compliance date. "This additional guidance will address concerns that were raised about challenges establishments faced in understanding how to meet their obligations under the new regulations," Gottlieb wrote in an August 25, 2017, statement. "We have been diligently working to address the comments we received, and to establish a sustainable framework for enabling establishments to effectively meet the new menu labeling provisions. These new policy steps should allow covered establishments to implement the requirements by next year’s compliance date." Issue 645
As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and Lindsey Heinz, with Associate Elizabeth Fessler, explain the debate in “Dairy Vs. Plant-Based ‘Milks’: A Regulatory Standoff." While Canada and the EU have both ruled that plant-based products cannot be called “milk,” the U.S. Food and Drug Administration (FDA) has yet to take determinative action to ensure that products using "milk" contain cow milk, though it does define the term as “obtained by the milking of one or more healthy cows." Although FDA has warned plant-based beverage manufacturers, the agency has not taken enforcement action against such products and has never ruled on a 1997 petition to allow the use of the term “soymilk.” Moreover, legislation has been introduced in both houses of Congress (H.R. 778; S.130) that…