On October 31, 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 webpage with news and resources regarding International Cooperation on Cosmetic Regulation (ICRR).
The Food and Drug Administration is correcting the docket number of its October 25, 2011 notice that announced the availability of a guidance for industry entitled “Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide” for a final rule that published in the Federal Register of June 22, 2011. The correct docket number for the notice announcing the guide is FDA-2011-D-0739.
U.S. Customs and Border Protection has issued CSMS Message #11-000273 announcing the Food and Drug Administration's review of private laboratory analyses for papayas. On August 25, 2011, FDA issued Import Alert #21-17 on the "Countrywide Detention Without Physical Examination of Papaya from Mexico." In this Alert, FDA states that such detention without physical examination (DWPE) of all fresh papayas from Mexico is appropriate based on the presence of salmonella.
The Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) have issued corrections to their September 15, 2011 notice which established dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium, as well as current and emerging approaches designed to promote sodium reduction. FDA and FSIS are correcting the names of two reports on sodium referred to in the September document as references.
On October 27, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency seeks comments on its discussion document on ENERGY STAR® specifications for residential climate controls. EPA is considering several changes to specification of these products, including: (1) incorporating a pathway for qualification of climate controls with remote interfaces that enable management of HVAC systems on smartphones, PCs, and other devices; (2) eliminating humidity measurement/display criteria; and (3) eliminating rate tier indication criteria. EPA states these changes could allow simpler, lower-cost residential climate controls to qualify, while retaining their key energy saving and usability criteria. EPA letter and discussion document are available by emailing a request to documents@brokerpower.com.
The Environmental Protection Agency is proposing to issue both a (i) “test rule” under Toxic Substances Control Act (TSCA) section 4(a)(1)(B) to require manufacturers (including importers) and processors of 23 high production volume (HPV) chemical substances to conduct testing to develop certain screening level data; and (ii) a significant new use rule (SNUR) under TSCA section 5(a)(2) for another 22 HPVs that would require EPA notification prior to manufacture, import, or processing of the substances for use in a consumer product, etc.
In response to requests, the Food and Drug Administration is extending the comment period to November 30, 2011 (from October 31, 2011) on its August notice announcing the fiscal year 2012 $224-$325 hourly fees on the food and feed industry for FDA (i) import reinspection activities (including addressing requests to remove a product from an Import Alert, to release detained articles, etc.1); (ii) facility reinspections; and (iii) recall activities resulting from a firm's non-compliance with a food recall order.
The Environmental Protection Agency has issued a final rule, effective November 21, 2011, to require manufacturers, importers, and processors to conduct certain testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances. EPA states that this test data is needed in order to help it to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety.