The Food and Drug Administration is extending until Jan. 31 the period of biennial registration renewal for foreign and foreign food facilities, it said in an update to its Q&A on food facility registration. FDA said it is taking this action because of the delay in beginning the period of registration renewal, which was required to start by Oct. 1, but did not begin until Oct. 22. The guidance said FDA is “exercising enforcement discretion” for food facilities that register during the Jan. 1-31 period, and encouraged facilities to register early.
The Food and Drug Administration has yet to publish several major rules related to implementation of the Food Safety Modernization Act, but has made a lot of progress, said Domenic Veneziano, director of FDA’s new Office of Enforcement and Import Operations, at the Food Chemical News’ Complying with FSMA’s Food Import Regulations conference Dec. 4 in Washington, D.C. Proposed rules on the Foreign Supplier Verification Program and Third-Party Accreditation have been submitted for Office of Management and Budget approval, and these programs, among others, will serve as important tools given FDA’s resource constraints, he said.
In a June 14 warning letter recently posted to its website, the Food and Drug Administration said Chinese drug manufacturer Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.’s products may not be allowed entry into the U.S. until the company renews its registration. Zhongnuo had previously been notified of its lapsed registration in an FDA letter dated March 26, but the FDA said it continued to find imports of Zhongnuo’s drugs even though the company hadn’t registered in 2011 or 2012. FDA said Zhongnuo is required to submit registration information annually by electronic means for each foreign establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the U.S. Failure to register is a prohibited act under Section 301(p) of the Food, Drug and Cosmetic Act.
The Food and Drug Administration is amending its regulations to comply with statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it said in a Federal Register notice. It said the change would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act and update rules to improve the quality of registration and listing information available to FDA.
The U.S. International Trade Commission released “The Year in Trade 2011,” its annual overview of the previous year's trade-related activities. The Year in Trade 2011 includes complete listings of antidumping, countervailing duty, safeguard, intellectual property rights infringement, and section 301 cases undertaken by the U.S. government in 2010. In addition, the 2011 report covers:
The office of U.S. Trade Representative released its annual 2012 Special 301 review process based on compliance with intellectual property rights, and IPR enforcement in 77 trading partners. The Special 301 Report provides a means for the United States to promote the protection and enforcement of IPR. For companies on the list, the U.S. Government could initiate dispute settlement proceedings at the World Trade Organisation (WTO) or other trade bodies, or eliminate tariff preferences.
The Office of the U.S. Trade Representative has determined to waive certain discriminatory purchasing requirements with respect to goods and services covered by Chapter 17 of the U.S.-Korea Free Trade Agreement (KORUS), which will enter into force on March 15, 2012.
The Animal and Plant Health Inspection Service has issued a final rule, effective May 1, 2012, to allow for the resumption of wooden handicrafts imports from China, provided that they are treated, documented, and their shipping packages are labeled with a merchandise tag containing the identity of the product manufacturer, and other conditions.
The Consumer Product Safety Commission has issued a final rule that effective August 29, 2012 amends 16 CFR Part 1224 to reference a revised mandatory consumer product safety standard for portable bed rails that are installed on the side of an adult bed and/or on the mattress surface to keep children from falling out of bed. The revised mandatory standard is ASTM F 2085-12, “Standard Consumer Safety Specification for Portable Bed Rails,” which was developed jointly by CPSC and ASTM. The CPSC's predecessor standard was ASTM F2085-10a.
The Consumer Product Safety Commission has issued a final rule that effective April 30, 2012 amends the CPSC's mandatory standard for all-terrain vehicles to reference the 2010 "ANSI Standard for Four-Wheel All-Terrain Vehicles Equipment Configuration and Performance Requirements" (ANSI/SVIA 1-2010), which covers both the adult and youth versions of ATVs. The prior standard referenced was the 2007 ANSI/SVIA version.