FDA to Continue Leniency with Co-packers Supplier Control Where Brands Have Oversight

FDA announced that they will continue to provide 'enforcement discretion' with supply chain controls for co-packers where the brand companies they are packing for have oversight over those suppliers.  In these cases, the co-packer is packing under contract for the brand company, and that brand company has chosen and then manages the suppliers who provide raw materials to the co-packer.

Certainly if the brand companies want the control over the supply chain to the co-packer, then they should be responsible for the supply chain control components and should have the procedures and documentation to support that.  This FDA announcement does not go that far, outside of providing an out for the co-packer.

From the announcement, "under certain circumstances and on a temporary basis, we do not intend to take enforcement action against a receiving facility that is a co-manufacturer, and that is not in compliance with certain supply-chain program requirements for food manufactured for the brand owner."

From the previously published guidance establishing enforcement discretion:
"Supplier Approval
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner conducts supplier approval activities, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when a brand owner (rather than the co-manufacturer) evaluates supplier performance as part of approving a supplier, the co-manufacturer’s food safety plan states that the brand owner will consider supplier performance before a supplier is approved, and the co-manufacturer conducts any other necessary supplier approval activities (e.g., hazard analysis of the food). The co-manufacturer is always responsible for following written procedures for receiving raw materials and other ingredients, and documenting use of the procedures (21 CFR §§ 117.420 and 507.120)."

"Supplier Verification
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner determines and/or conducts supplier verification activities for its co-manufacturer, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when an audit is determined to be the appropriate supplier verification activity but a co-manufacturer does not independently obtain a supplier audit or review the conclusions of a supplier audit obtained and reviewed by the brand owner, the co-manufacturer’s food safety plan states that the brand owner will obtain and review audits of the supplier, and the co-manufacturer conducts any other necessary supplier verification activities (e.g., sampling and testing of the raw material or other ingredient)."

FDA Constituent Update
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-supply-chain-program-requirements-and-co-manufacturer-supplier-approval-and
FDA Continues Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA
November 6, 2019

Blockchain - Opportunities and Challenges from a Food Safety Perspective

Blockchain is a term receiving a lot of hype as the must-have for food safety.  Well, at least the IT folks are pushing food safety as a main reason for investing into the technology.  There are benefits of having verifiable and seamless transactions

So what is blockchain - it is a tool by which each segment of the supply chain, or block, is identified from raw material through to the time is is sold.  The blockchain technology records each interaction with an item and assigns it a digital certificate so that the information associated with that block, or supply chain segment, can not be changed or adulterated later.  This prevents company form hiding the true origin and movement of the material as it moves through the chain.  

Traceability and recall are the real benefits.  Having such a system would allow quick identification of  recalled ingredients, and then coupling that with where those ingredients were used, and where that product was distributed or stored.

There can be endless amounts of information recorded with each transaction.  This can include 1) source information such as specific producing company, harvesting fields, or varieties harvested, 2) safety parameters such as temperatures, pH, or Aw, and 3) quality parameters.

One can establish validated contacts, or smart contacts, that help ensure product sourcing and provide means for seamless transactions.  For example, one can ensure that suppliers were indeed certified organic.  "Transactions can be verified and approved by consensus among the community, [theoretically] making fraud more difficult and significantly lowering the costs of validation and authentication" (PMA)

Are there limitations?  Sure. 1) Blockchain is not a specific thing but a process, and requires integration into a a company's existing systems....not always easy to do. How does a company's own procedures mesh into the system.  2) Coding issues, whether there are input issues or deletions, may create confusion, delays, or refusals due to misinformation.. 3) The information collected is only as good as the data input into the system. 3) It does create visibility, so what impact does that have on confidentiality of a company's process and to what degree does a company want to keep their supply chain information away from others, including potential competitors?  For example, maybe I don't want my downstream customer seeing my upstream supplier with the thought that my customer may cut me out so that they can make the product themselves.

So this is a tool that improves visibility and transactions along the supply chain.  No doubt a time saver for the food professional who has to hunt down supplier information.  It will help validate suppliers and ensure sourcing information.  But A savior for food safety?  That may be a stretch. Certainly IBM would like you to believe it.  In the end it still comes down to the basics - the blocking and tackling of people ensuring food safety basics.

To what degree are consumers demanding transparency to know exactly where their food comes from?  There are probably some out there who really, really care, but for me, I'm good with knowing my pizza is from Gigiarelli's or Pizza Perfect, my beer is from Troegs (Nugget Nectar), and my sub is from Giovanni's using those Amoroso's buns.

Supply Chain Quarterly.com
http://www.supplychainquarterly.com/news/20171201-lets-rein-in-the-blockchain-exuberance/
Forward Thinking
Commentary: Let's rein in the blockchain exuberance
By Mark Solomon | December 1, 2017