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

FDA Updates Preventive Controls Guidance With Chapter on Heat Processing PC

FDA updated their Preventive Controls Guidance document with a chapter on addressing the use of heat treatments as process controls.  To this point, the guidance provided somewhat similar information to that in the FSPCA manual, although the information is split differently among the chapters. However, the information covered in Chapter 6 goes into more detail, providing more information on heating, including examples for baking cookies, heating soup, and processing salsa.  This information covers how one would validate that information, and then implement and manage the process - monitoring, corrective actions, verification, and records.

Currently, the Guidance has 5 previous chapters, while Chapters 7 to 14 are yet to be released.

• Chapter 1 is an introduction
• Chapter 2 discusses how to conduct a hazard analysis.
• Chapter 3 provides additional information on hazards in foods. For example, it discusses pesticides, animal drugs, and mycotoxins as chemical hazards and when you may want to consider those hazards.  While it does not provide complete information on each of the hazards, it does provide some additional information.
• Chapter 4 overviews the preventive controls - Process, Sanitation, Allergen, and Supply Chain controls - highlighting primary types for each.  Under Process Controls, the chapter covers leathality treatments (heat, HPP, irradiation, fumigation), cold holding, formulation control, etc.  Again, not a complete listing of types, but give information on the major types.
• Chapter 5 is the application and management of preventive controls...provides some additional information to the preventive controls discussed in chapter 4.

Each of the coming chapters will expand upon the preventive controls as was done in Chapter 6 for heat processing.

This will become more of a companion reference document as examples of the process controls are expanded upon.  This guidance will give information on the types of things an FDA inspector will be looking for as they conduct inspections.  Certainly a document worth printing or bookmarking.  Be sure to watch for updated sections as they are released.

FDA Guidance - Small Company Version of Preventive Controls for Human Foods

FDA released their guidance titled: Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide.   LINK

This guide was developed to help small companies comply with the FSMA Preventive Controls Rule.

The guide does not introduce anything new.  It is basically a simplified version of the original rule.  Being simplified, the document does make the regulation more approachable.  One particular area is On-Farm Packing and Holding of Food (pg 22).  The guidance discusses those activities not subject to the requirements for Hazard Analysis and Preventive Controls when conducted on farms.

It also reviews the Qualified facility -  a facility that does not need to comply with the Preventive Controls component of the rule (21 CFR 117).  It has been our opinion however, for companies who fit into that definition to consider taking the step and completing the Preventive Controls component.  Why?  If the company grows, looks to gain sales from a customer requiring a HACCP type plan, or just wants to improve the safety of their product, they really need to consider taking this step.

FSMA Draft Guidance for Notifying Customers of Hazards That Need to be Controlled

FDA issued a draft guidance that applies to food containing a hazard that must be controlled by a customer that is a further processor (not a consumer). This applies to the FSMA rules for Human Food, Animal Feed, Produce, and FSVP. The guidance titled "Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry " (Link) details how to make a disclosure in documents accompanying food that certain hazards have not been controlled by that entity.  

For example, if Company A is selling pepper to Company B, and that pepper had not been treated to eliminate Salmonella (which Company A has identified as a potential hazard), Company A would need to disclose on paperwork / documentation that "the pepper was not processed to adequately reduce the presence of microbial pathogens". 

So what are the documents of the trade? It has to be something the manager in charge of food safety is likely to read: "documents accompanying the food, in accordance with the practice of the trade." See 21 CFR 117.136(a)(2)(i), (a)(3)(i), and (a)(4)(i). This allows for the disclosure statement to be provided using a wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read."   " It is permissible, for the purposes of the requirements of the part 117 disclosure statement, to use labeling that includes a disclosure statement such as "not processed to control microbial pathogens" and then directs the recipient to a website for additional information about those microbial pathogens."

How does it need to state the hazards?  "For biological hazards, we will consider a manufacturing/processing facility that describes the "identified hazard" using a general term (e.g., "microbial pathogens," "microorganisms of public health significance") rather than a specific biological hazard (e.g., Salmonella or Listeria" 

For a chemical or physical hazard, the statement must be more specific.  "For chemical and physical hazards, a manufacturing/processing facility that chooses to not control chemical and physical hazards and to rely on its customers to do so, would be subject to the requirements of the part 117 disclosure statement. We expect such a facility to describe the identified chemical or physical hazard using a specific term (e.g., "mycotoxins," "aflatoxin," "stones") that adequately communicates the key safety information regarding the chemical or physical hazard that needs to be controlled."

Again, this is only needed when the supplier identifies a hazard and is relying on their customer (non-consumer) to control that hazard.
 

Onion Rings Recalled Due to Allergen Mislabeling - Reason for Implementing Preventive Controls

McCain Foods issued a recall notice for Onion Rings and then reissued the notice to expand the recall to additional labels.  The pre-labeled packaging did not list milk on the label although it was included in the formulation.

This is the type of recall that the Preventive Controls rule was designed to help prevent.  By having a formalized check of the labels at the receipt of those labels and then again at the time of packaging would have provided 2 opportunities to compare the label to the formulation.  Of course, it is important to have the sub-ingredients listed, in this case, they are probably purchasing the breader / batter that will be used to coat the onion rings.

Instituting such a check is not overly difficult. It just takes a few minutes to compare the label to the formula.   However, the cost of recall resulting from non-compliance can run into the millions of dollars.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm522476.htm
McCain Foods USA, Inc. Announces a Product Recall Impacting Frozen Onion Rings Sold and Distributed Under Four Separate Private Label Retail Brands
For Immediate Release
September 23, 2016

First Day of Preventive Controls Compliance - What Do You Need to Know

September 19, 2016 marks the compliance day when larger facilities making human food must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs) and larger animal food facilities must meet CGMPs.

So what should one expect?  FDA issued two letters today.  To summarize from the many words in those documents:

At this point, the FDA is still learning so "the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements." 

Does your Food Safety Plan have to be perfect at this point - "Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry."

 But FDA will still evaluate the facility in order to make safe products. "The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food."
 
"In addition, facilities should set up a thorough system for documenting what they do."

FDA is still learning as well.


FDA News Release
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm521171.htm
What to Expect Now that the First Big FSMA Compliance Dates Are Here
Questions and Answers with Joann Givens

FSMA Compliance Date Schedule - September 18th for General Compliance

FDA's FSMA compliance dates are nearing.  Take a few minutes to review to see if you are where you need to be.

Source - GMA website
http://www.gmaonline.org/file-manager/GMA%20Summary%20Reference%20Sheet%20for%20FSMA%20Compliance%20Dates.pdf

*Farms have an additional 2 years to comply with certain water-related requirements. Separate compliance date applicable to sprouts.

**PC Human: Supply Chain Program general compliance is (1) 3-17-17 (9-18-17 for small business) OR (2) six months after a supplier is required to comply with the applicable rule. PC Animal: Supply Chain Program general compliance is (1) 9-18-17 (9-17-18 for small business) OR (2) six months after a supplier is required to comply with the applicable rule.

†All importers must comply with FSVP requirements by 5-30-17 OR 6 months after their foreign suppliers’ reach their FSMA compliance deadlines, whichever is later. “Very small importers” and “importers of food from very small foreign suppliers” are subject to modified requirements.

‡ 3PAC’s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by the FDA.

FDA Issues Draft Guidance for Facilities Sending By-Products for Use in Animal Feed

FDA issued a draft guidance for food processing facilities that send their by-products for animal feed. For example, a company sending peels or rinds after processing produce, or a company sending over baked cookies to a hog farmer.  The following is the important sections from this draft guidance.

FSMA - FDA Extends Deadline for Certain Provisions of Four Major Rules

As you know, the compliance dates are approaching for FSMA.  For Preventive Control for Human Foods, the compliance date for large firms in September 18th, 2016.  (This has not changed.)

But with this much of a major change in regulations, there will be areas where more guidance is needed from FDA for companies to figure out how to comply.  This is the case where these 6 issues resulted in the compliance dates being moved back, essentially 2 years from the proposed compliance date.

• certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. 
• for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. 
• for certain facilities that color RACs.  
• for facilities solely engaged in the ginning of cotton. 
• for importation of food contact substances. 
• for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.

The most impactful for those processing human and animal foods is the customer assurance requirement.  This provision requires the processor to make sure the downstream customer was going to take care of a hazard in the ingredient being sold.   Basically, if Company A is selling to Company B an ingredient containing a hazard, say for example Salmonella, where Company B said they were going to heat process that ingredient.  By Rule, Company A would need assurance that Company B was going to cook it sufficiently.   This, as written, may not be easy information to get.  (Specific sections of the posting below)

The other impactful section being delayed is for facilities holding or packing raw agricultural commodities that are not classified as a farm.  These facilities are more like a farm than a processor, but because of the way the rule was written, it classifies them more as a processor.  To help determine what these facilities need to do, FDA will write a specific guidance for these facilities. (Specific sections of the posting below)

Selected sections from:
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.
 https://www.federalregister.gov/articles/2016/08/24/2016-20176/the-food-and-drug-administration-food-safety-modernization-act-extension-and-clarification-of#t-1

FSMA Preventive Controls Rule for Human Foods - A First Look

The FDA released the final rule for the Preventive Controls for Human Foods. For those who have been tasked with reviewing the PDF file of approximately 930 pages, it is easy to become overwhelmed. However, it is not as bad as it looks. The actual regulation, which starts around page 834, is then roughly only about 100 pages. Considering that the GMP regulation is included (formerly 21CFR part 110) and there are many pages dedicated to discussing on-farm exemptions, the meat of the regulation is rather brief In fact, this version has been skillfully streamlined compared to the last released supplemental version.

So this primer takes a look at new aspects as well as walks through the major sections of the regulation.