GHY Tradelines

(CSCFSC)

On 12 February 2013, FDA provided additional details for the three consultation sessions that it has planned on the proposed regulations it published earlier this year. The public meetings will be held in:

• Washington on February 28th and March 1st
• Chicago on March 11th and 12th
• Portland, Oregon on March 27th and 28th

Detailed information about the meetings can be found here.

The FDA has also released a number of supporting documents about these proposed rules, including an overview document and two fact sheets (one for preventive controls and one for produce safety). These can be accessed the main FSMA webpage.

The initial comment period on “information collection issues” – i.e., concerns about the “paperwork burden” as required by the Paperwork Reduction Act of 1995 – closed on February 15^th but the comment period on the content of the proposed regulations is open until May 16th.
 

(FnB News)

FDA chief Margaret Hamburg predicted that her agency will issue new regulations needed to enforce the Food Safety Modernization Act, a sweeping piece of legislation enacted to upgrade the security of the U.S. food supply after a deadly salmonella outbreak in 2009, very soon.

Hamburg said the implementation process has been slow because Congress has not provided sufficient funds to meet the law’s ambitious demands.

The legislation imposes the biggest changes in food safety since the 1930s and requires the FDA to undertake a major shift from a longstanding reactive role to a system designed to prevent food-borne outbreaks. It also calls for the agency to create new science-based safety standards for fruit and vegetables, packaged foods and food imports.

“Implementing that broadly expansive mandate with limited resources has been a challenge,” Hamburg told a forum hosted by the Centre for Strategic and International Studies, a Washington-based think-tank.

Her comments come at a time when the FDA is working to meet a host of new priorities, including improved international drug regulation, while analysts and industry officials say the agency’s resources could fall prey to deficit reduction talks that are due to resume in Congress after the November 6 election. Read more here.
 

(Food Safety News – Dan Flynn)

In implementing its new Food Safety Modernization Act (FSMA), the United States wants to boldly go where no government has gone before in protecting food imports, but the European Union (EU) doesn’t like it.

Carlos Alvarez Antolinez, an EU food safety official stationed in Washington D.C., told the International Association for Food Protection (IAFP) Monday that the 27 member EU countries he represents has some significant issues with FSMA.

Third party auditing, inspections, and foreign supply verification procedures top the list of the EU’s concerns with the new U.S. law. With governmental authority for a continent of 500 million people speaking 28 languages, the EU is also in a position to stop what it does not like.

“We have been very grateful to the U.S. Food and Drug Administration (FDA),” Antolinez said. He said the EU has remained in constant dialogue with FDA since President Obama signed the new food safety law in January 2011, and seemed to suggest somewhat humorously that the U.S. and the EU might be more at impasse if the American government were further along in implementing the new law. Read more here.