CFR 117 Subpart G: Supply Chain Program

Food safety and the supply chain are two crucial components in delivering food to customers. While they are not the sole factors in management, analyzing each is essential to establish a potential relationship between them.

A supply chain constitutes a network encompassing the entire structure of your resources. It involves the journey of materials from extraction, through various transformation stages, until reaching the consumer. After obtaining finished products, they are directed to distribution networks that cater to wholesalers and retailers, ultimately reaching the end consumer.

The FDA Food Safety Modernization Act of 2011 (FSMA) designates the U.S. Food and Drug Administration (FDA) as the regulatory body responsible for food oversight within the U.S. Department of Health and Human Services. The primary aim is to enhance and safeguard public health through a modern, preventative, risk-based approach to food safety regulation.

On September 17, 2015, the FDA published the ‘Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Foods for Human Consumption’ rule under FSMA. This rule mandates that entities engaged in manufacturing/processing, packing, or food storage for human or animal consumption in the United States must register with the FDA unless exempted under 21 CFR 1.226.

The regulation, titled ’21. Food and Drugs; Chapter I – Food and Drug Administration; Department of Health and Human Services; Subchapter b – Foods for Human Consumption, part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,’ is divided into seven subparts:

• Subpart A – General Provisions.
• Subpart B – Current Good Manufacturing Practice.
• Subpart C – Hazard analysis and risk-based preventive controls.
• Subpart D – Modified Requirements.
• Subpart E – Withdrawal of a qualified facility exemption.
• Subpart F – Requirements Applying to records that must be established and maintained.
• Subpart G – Supply-Chain Program.
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In this article, our focus is on Subpart G and its key requirements for a supply chain program. It stipulates that facilities must institute and execute a risk-based supply chain program for raw materials, materials, and other ingredients with controlled hazards prior to receipt. Essentially, this enforces control measures throughout the supply chain.

Requirements Subpart G – Supply Chain Program:

• 117.405 – Obligation to Establish and Execute a Supply Chain Program: At this juncture, the receiving facility is mandated to institute and execute a risk-based supply chain program, barring specific circumstances. This program, documented in writing, is custom-tailored to address hazardous raw materials and other ingredients identified by the receiving facility, necessitating control measures throughout the supply chain.

A receiving facility that operates as an importer, adhering to the foreign supplier verification program requisites and possessing records of verification activities, is exempted from conducting supplier verification for that particular raw material or ingredient.

Exemptions Under this Subpart: The stipulations of this subpart do not extend to foods supplied exclusively for research or evaluation purposes. However, such foods must fulfill the following criteria:

• Not intended for retail distribution or public consumption.
• Appropriately labeled as “Food for research or evaluation use.”
• Supplied in a limited quantity aligning with research, analytical, or quality control aims. Solely intended for these purposes, any unused quantity is to be disposed of properly.
• Accompanied by documentation confirming the food’s allocation for research or evaluation, explicitly prohibiting public sale or distribution.

Third-Party Supply Chain Control:

In cases where an external entity other than the receiving facility’s supplier exercises control over the supply chain, the receiving facility must:

• Validate the accuracy of the supply chain control measures and acquire verifiable proof of validation from the external entity.
• Scrutinize and assess the pertinent documentation of the external entity, substantiating this scrutiny and assessment in documented form.

• 117.410 – General requirements applicable to a supply chain program.

The supply chain program must encompass the following elements:

• Utilizing approved suppliers.
• Defining appropriate supplier verification activities, including the frequency of implementation.
• Carrying out supplier verification activities.
• Recording supplier verification activities.
• If relevant, confirming a control established within the supply chain by an entity other than the receiving facility’s supplier. This confirmation should be documented, or suitable documentation of verification activities from another entity should be acquired. Subsequently, a review and assessment of this documentation must be conducted, with the results documented as well.

Several suitable supplier verification activities for raw materials and other ingredients involve:

• Conducting on-site audits.
• Employing sampling and performing analyses on the raw material or ingredient.
• Scrutinizing pertinent food safety records maintained by the supplier.
• Implementing appropriate supplier verification based on the supplier’s historical performance and the inherent risk linked to the raw material or ingredient.

During the process of approving suppliers and determining the frequency of supplier verification activities, the subsequent factors should be taken into account:

– An analysis of food hazards, encompassing the nature of the controlled hazard before the receipt of the raw material or other ingredient.

– Verification that the entity or entities responsible for implementing controls on the hazards have, indeed, applied controls within the supply chain.

– Evaluation of supplier performance.

**Food Safety and Supply Chain Management: Key Regulations and Documentation**

In the realm of food safety and supply chain management, adhering to specific regulations and maintaining meticulous documentation is crucial. Let’s delve into the provisions outlined in various sections and understand the requirements they entail.

**117.415 – Responsibilities of the Receiving Facility**

The receiving facility is mandated to undertake supplier approval, perform appropriate supplier verification activities, and comply with the documentation prerequisites set forth in this subpart. While entities other than the receiving facility can conduct supplier verification activities, the receiving facility must review and evaluate pertinent documentation, such as raw material receiving procedures.

For this subpart, supplier verification cannot involve supplier audits, reviews of supplier’s food safety records, or other verification activities.

**117.420 – Using Approved Suppliers**

Supplier approval, as dictated by the provisions in 117.410, is granted by the receiving facility. Procedures for receiving raw materials and ingredients must be established and followed, ensuring that materials are sourced solely from approved suppliers. Written procedures for this process must be documented.

**117.425 – Determining Appropriate Supplier Verification Activities and Frequency**

Appropriate supplier verification activities, along with their frequency, are determined based on the requirements outlined in 117.410.

**117.430 – Conducting Supplier Verification Activities**

For each supplier, one or more supplier verification activities specified in 117.410 must be executed before and periodically after using their raw material or ingredient. When a supplier controls a hazard in the raw material or ingredient, and there’s a potential for severe adverse health consequences, an on-site audit is required before use and at least annually thereafter. Notably, financial conflicts of interest and payment related to activity results are prohibited.

**117.435 – On-site Audit**

Qualified auditors conduct on-site audits of suppliers. If the supplier’s material is subject to FDA food safety regulations, the audit should encompass those regulations and involve a review of the supplier’s food safety plan.

For foreign suppliers, written results are valid when the FDA or the food safety authority of a recognized country conducts inspections.

**117.475 – Records for the Supply Chain Program**

Records documenting the supply chain program adhere to subpart F requirements. The receiving facility reviews and documents records as appropriate to its supply chain program. The documentation includes:

– Supplier approval records.

– On-site audit documentation.

– Sampling and testing records for supplier verification.

– Review records of the supplier’s relevant food safety data.

– Documentation of other applicable supplier verification activities.

– Records indicating alternative verification activities.

– Actions taken for supplier non-compliance.

– Verification documentation of supply chain controls by entities other than the supplier or receiving facility.

Balancing regulatory requirements and customer demands is essential for effective supply chain management. This balance involves profitability, customer value, consumer cost, quality, safety, delivery speed, reliability, and flexibility. Understanding these elements underscores the significance of the supply chain in the food industry.

References:

CFR – Code of Federal Regulations Title 21. (n. d.). https://www-accessdata-fda-gov.goog/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=117&_x_tr_sl=en&_x_tr_tl=es&_x_tr_hl=es-419&_x_tr_pto=sc

Tech, R. T. F. (2021, September 15). Food safety in the supply chain. THE FOOD TECH – Leading news media in the Food & Beverage Industry. https://thefoodtech.com/seguridad-alimentaria/inocuidad-de-los-alimentos-en-la-cadena-de-suministro/

21 CFR part 117 Guidance for Industry: Small Entity Compliance Guide https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM526507.pdf