US FDA issues draft norms on safety of imported foods, awaits comments

USFDA has now issued a draft guidance to support a new programme under its Food Safety Modernization Act (FSMA) that will help eligible foreign entities demonstrate that imported food meets US food safety requirements. The industry will now need to comment and provide its views within 75 days which is by mid- September 2015. 

Audits and certifications for eligible foreign entities under this programme will be used by importers applying for review through the Voluntary Qualified Importer Program (VQIP). It will be also required as a condition of granting imported food admission into the US when certain food safety risks have been identified.

The proposed rule would establish user fees for participation in the programme created by the accreditation of third-party auditors and certification bodies, according to the regulator. 

There would be a programme through which the FDA would recognise the entities that would accredit third-party auditors to conduct food safety audits and issue certifications.

The draft guidance is a set of model standards containing recommendations on the qualifications that third-party auditors/certification bodies, and their auditing agents, should have in such areas as education and experience.

Participation in the third-party accreditation programme will facilitate food safety protections, benefit trade, improve efficiency of FDA oversight of imported foods, and increase efficiency and reduce costs for importers with a high level of control over the safety and security of their supply chains.

The proposed rule to create user fees and the draft guidance document that outlines the model accreditation standards are both required by FSMA.

The food safety law requires a user fee programme be established to assess fees and reimburse the FDA for its work in establishing and administering the third-party accreditation programme. 

Participation in the programme is voluntary for third-party auditors and certification bodies. If the user fee proposed rule becomes final, both third-party auditors and certification bodies participating in the programme would be assessed fees based on the average cost to the FDA of performing certain activities for the programme such as application review and monitoring, according to the regulator. 

FSMA also requires that the FDA issue model accreditation standards. To avoid unnecessary duplication of efforts and costs with standards already in place, in developing these draft model standards, the FDA looked at existing international standards and current practices of existing accreditation bodies.

Commenting on the draft guidelines, Kaushik Desai, industry consultant, said that guidelines need to provide more clarity on the third-party auditors and certification bodies. Currently, Food Safety and Standards Act (FSSA) lacks a mechanism to test imported foods. Therefore, the USDA draft norms to ensure safety of imported foods is a step in the right direction.