Cross-Contamination Control Strategies Part 1: What are the top violations related to equipment and environmental sanitation?

The safety and quality of food products will rely greatly on the sanitation of the processor’s equipment and environment. Close to 18 years of regulatory agency data has shown that overall, 1-in-3 inspection violations in a facility may be directly related to insanitary equipment or environment.

This blog is the first of six designed to highlight the key challenges related to equipment and environmental sanitation. We start by introducing the key issues of focus (expounded upon in subsequent blogs) and the importance of maintaining the equipment and environmental surfaces in a clean and hygienic condition using appropriate food safety controls.

According to the World Health Organization, there are about 600 million cases of foodborne illness and 420,000 deaths annually, resulting in an estimated loss of 33 million years of healthy lives globally (1). Each year in the US alone, 1 in 6 people get sick from eating contaminated food, and about 3,000 deaths occur annually as a result (2). Effective controls for reducing foodborne outbreaks consist of four core pillars – Cleaning (sanitation), Cross-contamination Prevention, Cooking, and Chilling (3, 4).

Sanitation is a regulatory, industry standard, customer requirement, and a part of a food safety management system. It is required to produce safe, quality food and protect public health at local, national, regional, and global levels. A recent US study revealed that about “one-third of the FDA food recalls may relate to the cleaning and sanitation, hygiene, and material-handling practices that are required to maintain proper sanitary conditions within a processing facility for the production of safe and quality food” (5).

Therefore, besides achieving the primary objective of significantly minimizing the occurrence of foodborne illness outbreaks, good hygiene and sanitation procedures, practices, and programs (along with the other risk-based preventive controls) can all contribute toward reducing inspection violations, audit non-conformances, and food recalls.

Another recent review study (6) involved trending FDA inspection observations, spanning fiscal years 2006 to 2022. The FDA data was used to assess the common weak points in food safety and sanitation plans. The review revealed that issues related to equipment and environmental sanitation generally made up one-third of the violations listed in the top 50 citations for food facilities. These issues can be grouped into the following 12 focus areas, as illustrated below:

Potential areas of pest infestation occurring because of poor sanitation regimens

Inadequate operational precautions to control pathogen, allergen, or foreign material issues

Failure to clean plant building areas, e.g., walls, floors, ceilings, or other fixtures

Plant design and layout issues that may lead to food contamination problems

Unhygienic design and/or poor maintenance of equipment, tools and/or utensils

Improper cleaning and sanitizing of equipment, containers, tools, and/or utensils

Inadequate maintenance of areas in the immediate vicinity of the plant, e.g., outside grounds

Insanitary storage and transport of ingredients, other raw materials, and/or finished products

Drip, condensate, or similar issues that may contaminate food, contact surfaces, or packaging

Inadequate sanitation controls and monitoring of food contact surfaces and non-food contact surfaces

Hygienic zoning issues leading to cross-contamination by microbes, allergens, chemicals, and/or foreign bodies

Unsafe and/or inadequate use of cleaning and sanitizing chemicals or materials

Please note: Excluded from the above list are basic hygiene requirements like handwashing, use of gloves, availability of sanitary installations, as well as monitoring and record-keeping of sanitation activities.

Moreover, the 2023 FDA food facility inspection violation data shows a similar trend for these sanitation-related issues (7). Here are the top ten 2023 Equipment and Environmental Sanitation observations cited by the inspectors:

• 21 CFR 117.35(a) - Sanitary operations - plant maintenance
• 21 CFR 117.35(c) – Pest control
• 21 CFR 117.80(c) - Manufacturing, packing, holding – controls
• 21 CFR 117.40 - Equipment and utensils - design and maintenance
• CFR 117.20(b) - Plant construction and design
• 21 CFR 117.35(a) - Sanitary operations - plant sanitation
• 21 CFR 117.35(d) - Sanitation of food-contact surfaces – frequency
• 21 CFR 117.135(c)(3) – Adequate sanitation preventive controls
• 21 CFR 117.93 – Storage and distribution
• 21 CFR 117.20(a) - Grounds

Not surprisingly, certification standard auditors have noticed similar areas of violation. Here are the recent violation findings for the two of the most popular GFSI-benchmarked food safety standards, i.e. Brand Reputation through Compliance Global Standard (BRCGS) and Safe Quality Food (SQF):

Issue 9 of the BRCGS standard for food safety was launched in August 2022, and transition audits began in February 2023.

More information is at: https://www.brcgs.com/

The top equipment and environmental sanitation non-conformities of the BRCGS Food Safety Issue 9 Standard were related to the following clauses (8):

• Clause 4.11.1: “The premises and equipment shall be maintained in a clean and hygienic condition.”
• Clause 4.9.1.1: “Processes shall be in place to manage the use, storage, and handling of non-food chemicals to prevent chemical contamination.”
• Clause 4.6.2: “The design and construction of equipment shall be based on risk, to prevent product contamination.”
• Clause 4.4.8: “Doors (both internal and external) shall be maintained in good condition.”
• Clause 4.4.1: “The walls shall be finished and maintained to prevent the accumulation of dirt, minimize condensation and mold growth, and facilitate cleaning.”

The current version of SQF Code: Food Manufacturing is Edition 9. Audits against this standard began on May 24, 2021.

More information is at: https://www.sqfi.com/

The top equipment and environmental sanitation non-conformities of the SQF Food Manufacturing Edition 9 Standard were related to the following clauses (9):

• Clause 11.2.5.1: Cleaning and Sanitation Program - “...effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented...”
• Clause 11.2.1.1: Preventive Maintenance Program and Schedule - “...maintenance and repair of plant, equipment, and buildings shall be documented, planned, and implemented in a manner that minimizes the risk of product, packaging, or equipment contamination.”
• Clause 11.2.4.1: Pest Prevention Program - “A documented pest prevention program shall be effectively implemented...”
• Clause 11.1.7.2: Equipment and Utensils - “Equipment and utensils shall be designed, constructed, installed, operated, and maintained to meet any applicable regulatory requirements and to not pose a contamination threat to products.”
• Clause 11.1.2.4: Walls, Ceiling and Doors of Durable Construction and Condition - “Walls, partitions, ceilings, and doors shall be of durable construction. Internal surfaces shall have an even and regular surface and be impervious with a light-colored finish and shall be kept clean...”

Future blogs in this series will recommend solutions for these key equipment and environmental sanitation issues.

• PART 2: Cross-Contamination Control Strategies: A Focus on the Hygienic Design of Equipment and Premises
• PART 3: Cross-Contamination Control Strategies: Plant Layout and Process Control
• PART 4: Cross-Contamination Control Strategies: Managing Your Hygienic and Environmental Monitoring Zones
• PART 5: Cross-Contamination Control Strategies: Creating Better Cleaning and Sanitization Programs
• PART 6: Cross-Contamination Control Strategies: Dealing with the Pest Problem, Product Storage, and Transport Sanitation