The Food and Drug Administration has posted a blog by Deputy Commissioner for Foods Taylor on his recent meetings with Mexican counterparts. Taylor states that like the U.S., Mexico has embraced food safety as a priority and is in the process of establishing new mandatory food safety regulations, including produce safety regulations. Some of the themes that were emphasized throughout their discussions were consumer protection, science- based standards, the need for importer controls, and the importance and role of third- party certification. The trip was part of a larger strategy to reach out to stakeholders, both domestic and foreign, to explain the background and implementation strategies for the new Food Safety Modernization Act (FSMA) and to listen to issues raised by stakeholders.

On July 12, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

On July 11, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration is announcing the availability of a draft guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation." The draft guidance contains questions FDA has received on the final rule since its publication and responses to those questions. To be considered for the final version of the guidance, comments are due by September 12, 2011.

The Environmental Protection Agency has submitted to the Office of Management and Budget a proposed rule regarding stratospheric ozone, in order to authorize uses that will qualify for the 2012 critical use exemption from the phaseout of methyl bromide. The proposed rule would also authorize the amount of methyl bromide that may be produced, imported, or supplied from inventory for those uses in 2012. Absent this rulemaking, production and import of methyl bromide for critical uses would be zero for 2012.

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program announces a webinar on July 14, 2011, "Human Drug Export Compliance," which will focus on the regulations that govern the export of human drugs -- both approved and unapproved drugs. The discussion will include topics such as the FDA Export Reform and Enhancement Act of 1996, Transportation and Exportation (T&E) and Export Certificates. Registration is available here. The Web address for viewing the webinar is here.

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 Food and Drug Administration states that it expects to publish by spring 2012 a proposed rule to establish mandatory, science-based, minimum standards for the safe growing, harvesting, sorting, packing, and storage of fresh fruits and vegetables, as required by the Food Safety Modernization Act. FDA adds that it started working on the Produce Safety Regulation prior to FSMA's enactment.

On July 8, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

The Environmental Protection Agency has issued a proposed rule to approve revisions to the California State Implementation Plan (SIP) that EPA expects to be submitted by the California Air Resources Board. The revisions concern three regulations to reduce emissions of diesel particulate matter (PM), oxides of nitrogen (NOx), sulfur dioxide (SO2) and other pollutants from in-use, heavy-duty diesel-fueled trucks and buses and from ocean-going vessels (OGV) operating within California jurisdiction. EPA will not take final action to make the regulations federally enforceable until California submits the final adopted versions to EPA as a revision to the California SIP. Comments are due by August 10, 2011.