For the first time in 70 years the FDA is reforming their food safety laws. During the next 12 months, 7 new food safety laws, that have been under way for the last 4 years, will be published. The Food Safety Modernization Act (FSMA) that was signed into law by President Obama on Jan. 4th 2011 enables FDA to better protect public health by strengthening the food safety system. It gives FDA new tools and authorities to control, both the domestic food production and the import of food to the US. The rules are not yet published in the federal register, but for most of the laws, the contents are already known.
The main focus of the FSMA is the shift from a response-based approach to at preventative approach towards contamination. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply.
Foodborne illnesses are a significant public health burden, and it is expected that the new safety laws will be able to prevent a large part of the many yearly outbreaks.
In respect to imports, there are 5 key areas of change:
- Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)
- Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment)
- Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.
- Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)
- Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.
As the embassy is closely following the development of the FSMA, more information about the laws will be posted as soon as they are published. If you have any questions or inquiries, you are welcome to contact Counselor of Food and Agriculture, Anna de Klauman at anklasu@um.dk.