A key theme of the Food Safety Modernization Act (FSMA) is partnerships, and a key part of that is public and private collaboration on a global scale as well as within the U.S.
Speaking at the Global Food Safety Initiative (GFSI) Conference in Anaheim, Calif., in February, on “The Future of Private/Public Collaboration: Challenges and Opportunities,” FDA Senior Advisor for Policy Sharon Mahl discussed the collaboration opportunities between FSMA and GFSI.
FSMA represents a paradigm shift for U.S. import practices, Mahl said. In the past, FDA had to make decisions at the border with limited knowledge and limited resources. But that has now changed. With more than 12 million line entries of food from more than 100,000 facilities around the world coming into the U.S., “we also have to rely on the private sector to regulate its food,” Mahl said. “Importers now bear an explicit responsibility for the safety of their foods.”
GFSI has been a global leader, not only driving change and continuous improvement, but showing that it can actually deliver it, Mahl said. As such, FDA sees three of GFSI’s actions as being of particular importance to FSMA. These include:
- Benchmarking Guidance. GFSI has the same goals as FSMA. There are some statutory differences, but when GFSI standards are considered against FSMA, there is much similarity.
- Global Markets Program. This GFSI program focuses on the building of capacity in emerging markets. That is important in FSMA as well because goods are being imported from less developed and smaller markets, and it is critical that these also meet the standards and statutes.
- Auditor Competence. Congratulating GFSI on its work on auditor competency, Mahl said, “We would like to take it one step forward and actively partner with GFSI.” This collaboration not only would leverage GFSI’s work on auditor competence but also would help to ensure a greater supply of qualified auditors. This collaboration is of particular importance because of the role of private third parties in implementing FSMA and its specifications for “qualified individuals.” These are built into the Act’s framework for the foreign supplier verification program, voluntary quality importer program, import certification for certain high-risk foods, and accreditation of third-party auditors.
Trust. While there are numerous opportunities for partnering and collaborative use of auditors, consumer trust is dependent on transparency and government oversight, Mahl said. “So this can never be a substitute for government oversight. As soon as consumers think that is happening, we lose their trust.”
Thus, while using—and trusting—private auditors is part of the FSMA plan, qualification and certification will be essential. “We need to think about trust but certify,” she said. “If there are auditors out there, that’s great. But they need to be reliable and vigorous.” There is a natural distrust from the private sector toward regulators, as regulators historically go into a facility looking for violations. But, she said, “As we implement FSMA, all that has to change. We have to break down that barrier as well.”
However, Mahl said, “FSMA success is tied to our developing and implementing policies for the most rigorous food safety practices. The people in this room have told—and showed—us it can be done.”
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
FSMA Audit FAQs
Q. How will the third-party auditor accreditation program work? A. Section 307 directs FDA to establish a system for the recognition of accreditation bodies that accredit third-party auditors to, among other things, issue certifications for purposes of the import certification for food. The statute directs FDA to issue implementing regulations, including provisions on conflicts of interest, financial ties, and unannounced audits, as well as model accreditation standards, including requirements for regulatory audit reports. Q. Will auditors have to submit their audit reports to FDA? A. An accredited third-party auditor or audit agent of such auditor will need to prepare an audit report for each audit conducted. In the case of a regulatory audit, which the law distinguishes from consultative audits, it must submit the report to FDA. The law also has a provision whereby FDA may require the submission of certain reports from a regulatory audit and can access the results of a consultative audit in accordance with its records access authority under another provision of the Federal Food, Drug, and Cosmetic Act. Q. Will FDA allow automatic recognition under the accreditation and certification provisions for countries that adhere to ISO standards for inspection and accreditation bodies? A. In developing the model standards under the third-party auditor accreditation program, there is explicit language in the law that FDA must look to standards in place on the date of the enactment of this section for guidance, to avoid unnecessary duplication of efforts and costs. FDA will continue to consider international standards and leverage with accreditation bodies in developing these standards. Q. Does FDA have new compliance tools for imports? A. Yes. First, we will increase the number of foreign inspections we do. FDA can deny entry to an import if a foreign facility refuses an FDA inspection; it can require certification for high-risk foods; and prior notice submissions will need to include, as an additional element, any country to which the food has been refused entry. Q. Will third-party auditors have the same authorities and tools as FDA in qualifying imported food companies for entry? A. No. Accredited third-party certification bodies will not be commissioned by FDA nor otherwise be in the role of regulatory authority, acting on FDA’s behalf. This is true regardless of whether the accredited certification body is, itself, government (i.e., public) entity. |
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