Laboratory accreditation was mandated by the Food Safety Modernization Act (FSMA) over four years ago, but the Food and Drug Administration (FDA) has yet to propose regulations for implementing the new requirements. The agency’s court-ordered deadlines to complete certain FSMA regulations, including preventive controls, produce safety standards, and the foreign supplier verification program, has delayed the laboratory accreditation mandate. Laboratory testing is an important component of several FSMA regulations, however, prompting many stakeholders to urge the agency to expedite the accreditation rule.
Industry stakeholders, including food manufacturers, importers and commercial laboratories, have many questions about the emerging regulations for laboratory accreditation. Food manufacturers have questioned whether in-house labs would be required to comply with the accreditation rule, and how the requirements might impact routine testing. Commercial labs are wondering if the accreditation standard ISO 17025 will be accepted, or if a new accreditation paradigm will replace the existing standard. Also, what is the relevance of FSMA lab accreditation for private labs not involved with regulatory testing?
Responding to the confusion surrounding the implementation of the various regulations mandated by FSMA, FDA officials have held numerous meetings with stakeholders to field questions and to solicit comments about the upcoming regulations, including the lab accreditation rule. FDA officials have indicated a working group is developing a draft proposal and a proposed rule should be published by early 2016.
Why did FSMA mandate laboratory accreditation?
Ultimately, the objective of laboratory accreditation per FSMA is to align commercial laboratories with government labs, which would facilitate the acceptance of analytical data, improve the efficiency of government labs and support the testing of food imports. To ensure consistent quality in laboratory testing and analytical data, accreditation of both foreign and domestic laboratories would be required for all regulatory testing.
Under FSMA, the laboratory accreditation requirements would apply to the following types of regulatory testing:
- To support admission of imported food or removal of an Import Alert
- To comply with specific food testing requirement(s) under FDA regulations or the FD&C Act
- To address a food safety problem identified or suspected by FDA.
Laboratories could be expected to release test results that identify a food safety issue to FDA. The disclosure of laboratory test results could be required in cases of regulatory testing, but a final FDA regulation must clarify the specific requirements for disclosure. In the case of routine test results or non-pathogen microbiological testing for regulatory purposes, disclosure of the results is not mandated by the law.
As the rule evolves, the agency must clarify the relevance of accreditation to commercial laboratories, including its impact, if any, on non-regulatory testing conducted by private labs.
Will FDA develop a lab accreditation program?
FSMA requires FDA to increase the number of qualified labs for food testing to augment the agency’s field labs. As instructed by the law, FDA must develop an accreditation program for foreign and domestic food testing labs, and establish model standards for labs. Currently, several accreditation programs exist, and the federal labs are already accredited.
To implement the new requirements, the agency must first decide whether to create a new laboratory standard or to recognize an existing standard (i.e. ISO 17025). Industry stakeholders are concerned by the possibility that FDA might develop a new standard to replace ISO 17025 or that it would revise the established standard with unnecessary or duplicative requirements for lab quality systems, testing or reporting. Labs would be accredited to a model lab standard with specific sampling and analytical methodologies related to regulatory testing.
The program would require FDA to recognize third-party accreditation bodies to accredit both domestic and foreign labs for regulatory testing of food. Moreover, FDA must re-evaluate accreditation bodies every five years to ensure compliance with certain criteria, and maintain a public registry of accreditation bodies and labs accredited by approved accreditation bodies.
As stated previously, FSMA mandates lab accreditation for all food testing for regulatory purposes only. If FDA accepts the current accreditation system and lab standard, then the majority of commercial food testing laboratory networks in the U.S. are already in compliance for both regulatory and routine food testing.
How will the rule impact in-house labs and importers?
Will in-house laboratories be eligible for accreditation? Ultimately, the agency expects the laboratory accreditation rule to mandate a consistent and uniform approach to analytical testing based on an effective quality management system and technical requirements to ensure the accuracy and reliability of tests and calibration of equipment. Mandatory accreditation would have a significant impact on a manufacturer’s lab, but if such labs were exempt, the agency would need to justify the reason. At this time, the FDA has not disclosed information indicating how the regulation might impact in-house labs of food manufacturers.
What is the expected impact of lab accreditation on importers? The use of accredited laboratories would streamline the import system as FDA could trust analytical data from such labs and accept their Certificates of Analyses for releasing product into commerce. The use of accredited labs by importers would reduce the risk of detention and diminish a manufacturer’s risk of a food recall.
When will FDA publish the rule?
FDA officials have indicated a draft regulation is now under development by the FSMA Laboratory Accreditation Work Group. Due to the importance of lab testing for the key FSMA regulations, the agency is expected to collaborate with industry advocacy groups to finalize the proposal. The American Council of Independent Laboratories, the leading U.S. association of non-clinical laboratories, has been working on this issue with FDA authorities for years. Input from ACIL and other industry stakeholders will help to shape the final version of the proposed rule expected to be published early next year.