Sec. 306 Inspection of Foreign Food Facilities
The Secretary may enter into arrangements and agreements with foreign governments to fulfill FDA’s mandate to conduct the 19,000 annual inspections required by 2016. Inspections will be targeted based on risk.
Sec. 307 Accreditation of Third-Party Auditors
The legislation requires FDA to establish a program to recognize accreditation bodies and thirdparty auditors including foreign governments, foreign cooperatives or a private entity. This audit will determine if a facility is eligible to offer food for import under the voluntary qualified importer program.
Food Safety Modernization Act: Additional Considerations & Opportunities
Multiple drivers are currently impacting the food safety landscape and many changes are in motion, independent of the new legislation. The implementation of the new legislation will take time and is largely dependent on funding and how FDA drafts the regulations. The extent to which the U.S. Congress funds food safety will directly impact how much FDA can accomplish towards increasing inspections, and implementing new programs. However, the FDA will proceed with the writing of the regulations and thus set expectations and requirements.
The new legislation won’t change the food safety landscape overnight, but there is a unique opportunity for industry leaders to share bestpractices with FDA, participate in shaping the new regulations and guidance, and position themselves to have the solutions to meet the needs created by the new requirements.
By following the developments in U.S. regulatory policy over the coming years and evaluating your business practices against current standards, when the time comes for FDA to open a new “Green Lane,” your company could be one of the first to gain expedited clearance for your products into the United States. Liningup and working with leading independent third party auditors consultants, laboratories or foreign governments to accomplish this goal is critical to providing the necessary assurances to FDA that a protective and reliable food safety system is in place for your imported products.
This paper was co-authored by Leavitt Partners and Eurofins. For more information, contact James Acheson at James.Acheson@LeavittPartners.com