• The Acheson Group

FSMA Updates Impact Co-Manufacturers and Labs


Although FSMA has been in force for quite some time now, FDA is continuing to issue updates, along with proposals for rules which are required by the Act but had not yet been established. Two of these came out in November: an update on FDA’s plan to continue to its enforcement discretion for co-manufacturers and the Proposed Rule on Laboratory Accreditation.


Co-manufacturer Enforcement Discretion. If you were not aware of the enforcement discretion, don’t feel uninformed. The original statement was a single line in the Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food guidance document, issued in November 2017, in which FDA stated: “We do not intend to take enforcement action regarding the affected provisions until November 6, 2019.”


Three of FSMA’s rules – the two Preventive Controls rules (Human Foods and Animal Food) and the Foreign Supplier Verification Programs – require that supplier approval and supplier verification provisions be met by co-manufacturers that are receiving facilities and/or importers that produce food for the brand owners. While the requirements are designed to ensure suppliers are addressing hazards requiring a supply-chain-applied control, in some situations the detailed information the co-manufacturer needs to comply could conflict with confidentiality clauses in contracts between brand owners and the co-manufacturers’ suppliers.


Thus, the past year of non-enforcement was intended to give brand owners more time to work with suppliers to adjust contracts so that supply chain-related information could be shared with co-manufacturers. That has now been further extended because FDA has learned of additional challenges industry faces. FDA did not state how long it would continue its discretion, but noted that it will continue the policy while working to better understand the challenges that co-manufacturers face and consider possible solutions to address them.


Meanwhile, co-manufacturers should continue complying with other applicable requirements and give TAG a call if you have any questions or want assistance in compliance.


Laboratory Accreditation. FSMA also has a requirement for FDA to establish a program for the testing of food by accredited laboratories, model standards for such an accreditation, and a publicly available registry of accreditation bodies and laboratories. FDA was required to establish the program within two years of FSMA’s signing; because that did not happen, the Center for Food Safety (CFS) and Center for Environmental Health (CEH) sued FDA in August for failure to do so.


Possibly in response to the lawsuit, but likely already in the works, On November 11, FDA published a Proposed Rule to Establish Laboratory Accreditation Program for Food Testing on November 11. The program will require testing by accredited laboratories of human and animal food in certain circumstances. The accredited laboratories would be required to follow model standards and be subject to oversight by FDA-recognized accreditation bodies to help ensure consistently reliable testing results. The proposed program is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories.


The rule is seen as important because food testing is currently conducted by private laboratories that may conform to a variety of standards and be subject to various levels of oversight. Under the proposed program, only laboratories accredited by an accreditation body recognized by FDA would be able to conduct the following food testing:

  • To provide evidence to support the admissibility of imported food into U.S. commerce.

  • Under an import alert through successful consecutive testing.

  • To address an identified or suspected food safety problem which is presented to FDA as part of evidence for an informal hearing before a mandatory recall order; as part of a corrective action plan submitted after an order suspending the registration of a food facility; or as part of evidence submitted for an appeal of an administrative detention order.

  • In response to a newly proposed Food Testing Order, or to comply with specific FDA testing requirements, to address an identified or suspected food safety problem.

The results of testing conducting under this program will be required to be sent directly to FDA by the accredited laboratories.


This latter point is the only real red flag that TAG sees with these two new updates. The point about a “Food Testing Order” creates questions about what the triggers will be for FDA to put such an order in place and how long it will last. Since the data from such a testing order will be sent to FDA, any facility under that order may find itself under a lot more FDA scrutiny if the testing results do not go so well. I certainly understand the public health logic of the FDA approach – but the industry also needs to understand the potential impact of such an order.


As a “modernization” act with requirements for regular review and modification, FSMA is intended to foster ongoing action and continuous improvement in food facilities. With the last major food legislation having been enacted more than 70 years prior to FSMA’s signing, we can expect it will likely be a long while until the next. But we also can expect it continue to be actionable in that time, with updates, improvements – and eventual finalization of the rules – from FDA in the years to come.


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

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