U.S. Customs and Border Protection has issued a CSMS message announcing that the Food and Drug Administration has created two new Affirmation of Compliance (AofC) codes - KIT and DDM - to address shipments of kits containing finished devices imported into the U.S.
On December 15, 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 posted a November 30, 2011 presentation with a broad overview of its import operations and how it regulates imported products. It describes in general terms the statutory authority of Section 801 of the Federal Food Drug & Cosmetic (FFD&CA), FDA's entry review process, detentions, examinations and sampling, refusal of admission, etc.
On December 14, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On December 13, 2011, the Food and Drug Administration issued a warning to consumers about a potential association between the development of illness in dogs and the consumption of chicken jerky products. The products, also called chicken tenders, strips, or treats, are imported from China. FDA continues to receive complaints of sick dogs that their owners or veterinarians associate with eating chicken jerky products though testing to date has not determined a precise cause for the reported illnesses. FDA states that it continues to actively investigate the problem.
The Environmental Protection Agency has released a letter inviting a broad assortment of laboratories to participate in the final stages of the EPA's development and validation of the ease of use test method for residential climate controls. Given the similarity of these products to programmable thermostats, EPA regards usability as a key feature for delivering on their energy saving potential. The new test method must be able to reliably differentiate highly usable products, which are more likely to deliver savings, from those that are more difficult to program and use. EPA will host a call on December 20, 2011, 1:00PM EST to discuss this round robin and EPA-recognition for labs. RSVP to climatecontrols@energystar.gov or Abigail Daken at daken.abigail@epa.gov, (202)-343-9375, by December 16, 2011.
The Environmental Protection Agency has added three hydrocarbons as acceptable alternatives in household and small commercial refrigerators and freezers through EPA’s Significant New Alternatives Policy (SNAP) program. The three hydrocarbon refrigerants approved as acceptable substitutes, with use conditions, are propane, isobutane, and a chemical known as R-441A. These newly-approved refrigerants can be used to replace ozone-depleting chlorofluorocarbon (CFC)-12 and hydrochlorofluorocarbon (HCFC)-22 in household refrigerators, freezers, combination refrigerator-freezers, and commercial stand-alone units.
On December 13, 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 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 12, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: