We Are One Step Closer to Foreign Facility Certification
Updated: Nov 22, 2018
FDA has taken the next step in implementing the Accredited Third-Party Certification program of FSMA, launching a website where organizations can apply to be recognized as accreditation bodies. With the launch, foreign governments and agencies or private third parties can apply online to be recognized as an accreditation body to conduct food safety audits of foreign food entities and, based on their findings, issue certifications of those entities and the foods they produce.
One of the important points to remember about this program is that is focused on two very specific areas, namely the Voluntary Qualified Importer Program and the need for certificates for high risk foods. Thus, the certifications may be used to help certify entry for certain high-risk foods and/or to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food for eligible participants. (In late 2016, FDA issued its VQIP guidance which we discussed over two newsletters, Expedite Entry of Your Imported Foods and Writing Your VQIP QAP. Additionally, we’ve compiled a FSMA page that includes links to the full rule, guidance, and compliance dates for this and all the rules of FSMA.)
The voluntary certification program is intended to expand FDA’s oversight of imported foods through its recognition of “accreditation bodies” responsible for accrediting third-party “certification bodies.” The certification bodies conduct food safety audits and issue certifications for foreign food facilities. The goal is to address potential safety issues before the food reaches the U.S. and help ensure that imported foods are produced in accordance with the same safety standards as those required of U.S. foods.
What does this mean to you?
If you are interested in participating in the VQIP, it means we are one step closer to the ability to be certified. Or if you are an organization or foreign government interested in being recognized as an accreditation body, you can now get started on your application.
A point that we often forget with FSMA is the FDA has the authority to designate certain imported foods as “high risk.” FDA can then require that such foods be accompanied by a certificate indicating that they meet FDA requirements. So far as far as I am aware, FDA has not used this program. But this new information from FDA is establishing the process whereby such certificates can be issued using certification bodies and accreditation bodies discussed in the Accredited Third-Party Certification program.
There are a few important things to know about the program and its audits – for those interested in being accreditors/certifiers as well as those who want to be certified. One of the most significant is that of reporting. Under the Accredited Third-Party Certification Program certification bodies examine entities to determine if they are complying with applicable FDA food safety requirements and/or some industry standards. Audits can be consultative or regulatory, but in either case, FDA requires that it “be notified immediately if the audit reveals conditions that could cause or contribute to a serious risk to public health."
Thus, while it may seem that GFSI certification program owners (also known as scheme owners) or third-party auditing companies would be a perfect fit for conducting these audits, and that combining audits could simplify the process for foreign food facilities and foods, the requirement to report to FDA puts a bit of a glitch in those ideas.
That said, there certainly could be a place for certification bodies to look into this and decide to get involved. But with the FSMA food safety certification audit being a very public process, there would certainly need to be a well-understood separation of audits, and likely of auditors themselves. So, both because of this and to fulfill the requirement that the accreditation body "possess and demonstrate authority" as well as capacity and competence, I would think that foreign governments also will apply.
All – whether public or private – will have to go through the process; and all accreditors and auditors will have to maintain a high level of accountability and compliance. FDA has said that if auditors “screw up” they will be excluded from the program, and there has been mention of publicly listing those who have been “barred” from the program.
But before auditors can begin inspecting foreign facilities to enable their certification; before auditors can even be selected for the job, accreditation bodies need to apply and be recognized by FDA. Once recognized, an accreditation body is approved, it is to:
Accredit certification bodies to issue certifications under the program.
Assess third-party certification bodies, including observation of the applicant's work, to determine if they can be accredited.
Monitor the performance of the certification bodies it accredits, notifying FDA of any change in, or withdrawal of, accreditations it has granted.
Assess and correct any problems of the accreditation body.
Submit monitoring and self-assessment reports and other notifications to FDA.
Maintain and provide FDA with access to the records required under the program.
If you are interested in applying, visit https://www.access.fda.gov, Select "Create New Account" and then select the appropriate box under FSMA. Or, for more information, see FDA's Key Facts, or the full Accredited Third-Party Certification Rule.
So, there are still a few steps remaining before we will actually see audits being conducted and certificates issued, but the next step has begun. At this stage, one has to wonder how many will sign up, given the need to report findings to FDA. This will be a very interesting space to watch, and I am skeptical that VQIP will be a big driver. But if FDA starts to create lists of foods, manufacturers, regions, or countries that require certificates before being allowed into the US, then there will be a huge business incentive for joining this program. So keep watching this space, it could evolve very dramatically and very quickly. TAG will continue to watch this space as well, and let you all know what is happening.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com