As the Food Safety Modernization Act (FSMA) continues to be
implemented, Jim Cook of SGS Food Safety Services explains
the latest regulatory updates and how food manufacturers can
prepare for the act’s ongoing implementation.
with Jim Cook, Food Scientific and Regulatory
Affairs Manager, SGS Food Safety Services
Q: What are the latest requirements coming out
of the FSMA?
A: To start the year, the FDA published two proposed rules:
Preventative Control for Human Foods (section 103) and the Produce
Safety Standards (section 105). The initial comment period for the
proposed rules has been extended and now closes on November 16,
2013. The preventative control rule will affect almost all manufacturers selling food in the U.S. The FDA held three public meetings on this rule and published tool kits for farmers explaining
the water standards, alternatives and variances, etc. in the produce
safety standard. A couple of interim final rules were also finalized:
the Administrative Detention of Human and Animal Food (section
207) and the Prior Notice of Import Food Rules (section 304). The
FDA also has published a small entity guide for the administrative
detention of foods, as well as a tool to help facilities perform vulnerability assessments (section 106).
The FDA has sent their report on the pilot studies for improving
product tracing along the food safety supply chain (section 204)
to Congress. The proposals for the Accreditation of Third Parties
to Conduct Food Safety Audits and for Other Related Purposes
(Section 307) and Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals (Section 301) were
released on July 26, 2013. For the third party audits the Model
Accreditation Standards still need to be published.
Q: What steps should food manufacturers take to comply
with these requirements?
A: First — and this is the hardest part — food manufacturers must understand the requirements of the FSMA and all the
regulations. Many of these regulations are intertwined, so there is a
certain amount of complexity to the FSMA. Once the requirements
are understood, then a food safety team should be appointed. This
team should include members from a cross section of all areas of
operations and involve key management personnel.
The food safety and management systems must then be evaluated to identify any deficiencies. For example, if a food manufacturer already has a HACCP system that performs hazard analysis
for chemical, physical and microbial hazards, then radiological
hazards will be identified as a missing component. As required by
the FSMA, these risks must now be assessed and a system to close
the gaps established. This can mean treating the gap as a deficiency
in the existing food manufacturing system and determining what