EU 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.
FDA has drafted the implementing regulations, but the White House's Executive Office of Management and Budget (OMB) have held those up for months.
The EU is concerned that with the FSMA, the U.S. will be reaching out to individual companies in its member countries rather than maintaining a "government-to-government" approach for ensuring food safety, Antolinez says.
"Our concern is about duplication of controls," he says.
He suggested that U.S. plans for third party auditing are going to run up against some immediate limitations involving both the physical and institutional environment. He said the EU's system is based on national authorities and official controls.
"We honestly feel this is how it should be," Antolinez added.
The EU's approach is to audit national authorities of member nations, not individual companies. He suggested that with the EU - the largest market for food in the world -- doing only three or four audits a year in the U.S. that there would be a large asymmetry if FDA were allowed to audit hundreds of individual European companies.
Also, FDA's authority to charge companies being audited for the service probably is not going to go over in Europe. "We don't charge for inspections," says Antolinez.
European and American food laws are at their roots largely the same, Antolinez said. He said the EU's food law was "dramatically changed" in the late 1990s and has been based on food of animal origins being of greater risk than plants.
Because of the similarities between the two bodies of food law, Antolinez is hopeful that solutions can be reached between the EU and U.S. as the Food Safety Modernization Act moves down the road.
IAFP also heard from Jenny Scott, one of the FDA officials responsible for implementing the new law and from Pamela Wilger, Cargill's expert on third party certifications and foreign supplier verifications.
The FSMA talks came on the second day of IAFP annual meeting being held this year at the Rhode Island State Convention Center.