The Food and Drug Administration announced that it has decided to widen its look at arsenic in apple juice and other juices, as it is seeing a small percentage of individual samples tested that contain higher levels of arsenic than the 10 parts per billion limit allowed in public drinking water. FDA plans to consider all the relevant evidence and, based on this work, may set a guidance or other maximum level to further reduce arsenic in apple juice and juice products. As part of this effort, FDA will enhance surveillance in apple juice and concentrate, continue to test samples of apple juice imported into the U.S. from China, begin to sample additional types of juice and concentrate, and work with the Environmental Protection Agency to coordinate the review of a risk assessment being prepared and discuss other steps the two agencies can take to reduce the overall levels of arsenic in the environment and in foods.
On December 9, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has updated its frequently asked questions document to clarify the intent behind its November 25, 2011 notice seeking expedited approval by the Office of Management and Budget of a proposed information collection related to an Economic Hardship Fee Reduction Guidance. FDA explains that the notice was meant to indicate its intent to issue the guidance for FY 2012 hardship reductions requests. It adds that this Economic Hardship Fee Reduction Guidance is separate and distinct from FDA's development of a proposed set of FY 2013 guidelines in consideration of the burden of fee amounts on small businesses.
On December 8, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Natural Resources Defense Council announced that the Food and Drug Administration has committed to decide by March 31, 2012 whether the chemical Bisphenol A, or BPA, which NRDC claims causes brain damage in developing babies, infants and young children, should be banned from use in packaging for food and drinks. The agency agreed to address the use of BPA as part of a settlement reached on December 7, 2011 with NRDC.
On December 7, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is announcing a December 19, 2011 public meeting and seeking comments on proposed recommendations it has developed with the regulated community toward a draft Generic Drug User Fee Act. The draft legislation would authorize FDA to collect user fees related to human generic drugs and use them for the human generic drug application review process and associated submissions, to conduct related inspections (particularly of foreign manufacturers), and to engage in other related activities for fiscal years 2013-2017.
The Environmental Protection Agency and the National Highway Traffic Safety Administration have issued a proposed rule to further reduce greenhouse gas emissions and improve fuel economy for light-duty vehicles for model years 2017--2025. This proposal extends the National Program beyond the greenhouse gas and corporate average fuel economy standards set for model years 2012--2016. NHTSA is proposing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended by the Energy Independence and Security Act, and EPA is proposing greenhouse gas emissions standards under the Clean Air Act. These standards would apply to passenger cars, light duty trucks, and medium-duty passenger vehicles built in the 2017-2025 model years. Comments are due by January 30, 2012.
On December 6, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has issued its Biennial report to Congress on the Food Emergency Response Network, which is an integrated, secure laboratory system for Federal, State, and local government agencies engaged in food safety and defense activities. The report, which is required by the Food Safety Modernization Act (FSMA), states that FERN plays a critical role in food safety and defense by integrating these food-testing laboratories into a network that is able to detect, identify, respond to, and aid in the recovery from emergencies involving biological, chemical, or radiological contamination of food.