Accredited Third-Party Certification Rule
Covered facilities that operate under FSMA Final Rule on Accredited Third-Party Certification should be aware of the following changes outlined in the Ruling:
This rule deals with accreditation of third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities and foods for humans and animals and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA). It is significant from the following two aspects.
- Third party certification is a requirement for participating in the voluntary qualified importer program (VQIP);
- In addition, an imported food is subject to certification under FSMA, FDA may require a certification under this rule as a condition for admitting the food into the United States.
The rule establishes the requirements for the legal authority, competency, capacity, conflict of interest safeguards, quality assurance, and records procedures that accreditation bodies must demonstrate to be eligible for recognition.
Accreditations of Third Party Certification Bodies
Who is eligible to seek recognition?
A foreign government, agency of a foreign government, foreign cooperative, or other third-party would be eligible for accreditation from a recognized accreditation body (or, where direct accreditation is appropriate, FDA) to conduct food safety audits and issue food and facility certifications under the program.
What legal authority must a third party certification body have to qualify for accreditation?
Third party certification bodies to demonstrate that they have adequate legal authority, which may include authority established by contract or as a government entity to evaluate eligible entities for compliance with the applicable requirements of the FD&C Act and FDA regulations.
How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
The accredited third-party certification body would require the eligible entity to identify whether it was seeking a consultative or regulatory audit subject to the requirements under the third-party certification program. The eligible entity would indicate the scope and purpose of the requested audit and, in the case of a regulatory audit, would indicate the type of certification sought. The accredited third-party certification body would also require the eligible entity to provide a 30-day operating schedule for the facility that would provide information relevant to scope and purpose of the audit. The accredited third-party certification body would then consider whether the requested audit is within the scope of its accreditation.
The accredited third-party certification body is to ensure it would have adequate authority to conduct the requested audit, including authority to: (1) Conduct an unannounced audit; (2) access any area of the facility or any of its records relevant to the scope of the audit; (3) use an accredited laboratory where FDA requires sampling and analysis; (4) notify FDA immediately upon discovering, during a consultative or regulatory audit, a condition that could cause or contribute to a serious risk to the public health; (5) prepare audit reports that would contain certain elements and, for regulatory audits, that would be submitted to FDA; and (6) allow FDA and its recognized accreditation body to observe any food safety audit under the program.
What must an accredited third-party certification body do when issuing food or facility certifications?
The certification body to have conducted a regulatory audit and to conduct any other activities necessary to determine compliance under the applicable food safety requirements of the FD&C Act and FDA regulations. No certificate could be issued until the eligible entity took corrective actions to address any deficiencies reported.
What is the duration of accreditation by a recognized accreditation body?
The accreditation of a third-party certification body may be granted for a period up to 4 years.
- Alcoholic beverages made at foreign facilities.
- Meat, poultry and egg products that are overseen by the U.S. Department of Agriculture.
The FDA Intends to implement this program as soon as possible.