The Food and Drug Administration has made available two presentations on the Food Safety Modernization Act (FSMA) -- one provides an overview of the new law, and the other focuses on its import safety provisions, which FDA states are the most groundbreaking shift of the FSMA. Both also list the implemented FSMA provisions.
On July 28, 2011, the U.S. International Trade Commission released “The Year in Trade 2010,” its annual overview of the previous year's trade-related activities.
The Food and Drug Administration is announcing the fiscal year 2012 fee rates for certain import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, all of which are mandated in the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Food Safety Modernization Act (FSMA).
The Consumer Product Safety Commission has issued a proposed rule that would amend CPSC's mandatory standard for all-terrain vehicles, which is currently the 2007 "ANSI Standard for Four-Wheel All-Terrain Vehicles Equipment Configuration and Performance Requirements," developed by the Specialty Vehicle Institute of America (ANSI/SVIA 1-2007). The proposed rule would update CPSC's mandatory ATV standard, which covers both adult and youth versions of ATVs, to reference the 2010, not the 2007, version of the ANSI/SVIA standard.
The Consumer Product Safety Commission is issuing a final rule, effective August 18, 2011, which determines that children’s upper outerwear in sizes 2T to 12 or the equivalent, which have neck or hood drawstrings, and in sizes 2T to 16 or the equivalent, which have waist or bottom drawstrings that do not meet specified criteria, present substantial product hazards and are subject to immediate reporting requirements, recalls, and will be refused admission into the U.S. See below for information on determining size equivalents to 2T to 16 and a CPSC comment that equivalently sized products that are ambiguously labeled or not clearly marketed for adults should comply.
The Office of the U.S. Trade Representative has announced decisions not to initiate two “Section 301” investigations1. The decisions are in response to separate petitions filed in May 2011 requesting investigation of alleged: (i) misconduct by the Government of Israel during the negotiation in the 1980s of the U.S.-Israel Free Trade Agreement; and (ii) expropriations without adequate compensation by the Dominican Republic, resulting in an alleged breach of the Dominican Republic’s obligations under the DR-CAFTA2, etc.
The Food and Drug Administration is seeking comments and information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes. The information FDA receives will inform its development of guidance required by the Food Safety Modernization Act (FSMA) on preventive controls for facilities that manufacture, process, pack, or hold human food or animal food/feed.
The Consumer Product Safety Commission has issued a final rule that creates a new “Substantial Product Hazard List” and names as the first product on the list, any hand-supported hair dryer without UL-compliant integral immersion protection. Effective July 28, 2011, these non-compliant hair dryers must be immediately reported to CPSC, are subject to recall, and will be refused admission into the U.S. A similar rule for drawstrings in children’s upper outerwear is expected.
The Office of the U.S. Trade Representative has announced that it is terminating all of the remaining 100% duty rates imposed on certain products of European Union countries as a result of the EU’s failure to comply with the 1999 World Trade Organization rulings in the EU-U.S beef hormones dispute. The USTR states that it is taking this action due to a 2010 court ruling, even though the 100% duty rates had been set to expire in August 2012 under an agreement reached with the EU.
The Food and Drug Administration has issued a Federal Register notice with additional details on its already announced June 6, 2011 public meeting on inspections and compliance under the Food Safety Modernization Act. The meeting will provide a brief overview but mostly seek public comment on the following new FDA authorities: increased inspections, greater flexibility to administratively detain food, ability to suspend facility registrations, mandatory recalls, etc.