Regulatory responsibilities, consumer awareness, and a focus on public health are challenging food and beverage processors to choose the right food-grade lubricant for every application in their processes. Here’s what you need to know.

Consumers report a “bad taste” or a “smell like tar.” Some say they had an upset stomach or a burning sensation in the throat. The culprit? Lubricants.

During the last 25 years, contamination stemming from machinery lubricants in food and beverage manufacturing has resulted in lost consumer confidence and recalls, not to mention threats to public health. Without the use of appropriate food-grade lubricants and Standard Operating Procedures (SOPs), any food and beverage manufacturer can be vulnerable to contamination.

Despite contamination risks, research shows that about 60% of U.S.-based food and beverage manufacturers have not switched from conventional oils and greases to food-grade lubricants. Many still use oils that elevate the risk potential for contamination that could essentially shut down an operation.

With the adoption of the Food Safety Modernization Act (FSMA) in 2011, manufacturers creating food, pharmaceuticals, and dietary supplements must implement systems and controls to address hazards. This includes assuring that lubricants are food-safe.

So, what exactly are food-grade lubricants, and how can a food and beverage manufacturer achieve compliance? What essential training and maintenance programs should be put in place to prevent contamination? This article will explore these food-grade lubricant basics and more.

Assessing Risk: A Closer Eye on Lubricants in Food Processing

Before diving into the types of lubricants commonly used in food manufacturing, new responsibilities due to regulations and how to effectively implement a safe and healthy program, let’s address why the food manufacturing industry is under pressure to adopt stringent best practices related to lubrication.

The United States government agencies involved in food processing are the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Before 1998, all food-grade lubricant oversight and formulation review were the responsibility of the USDA. Lubricant manufacturers were required to prove that their formulas complied with a series of guidelines referred to as Title 21 under the Security Code of Federal Regulations (CFR).

Then, the USDA put the responsibility on manufacturers to assess risk following a shift in its program in February 1998. This meant lubrication manufacturers were charged with assuring their lubricant ingredients were safe. Because of the weighty responsibility, this major program change resulted in third-party consultants and vendors entering the market to help manufacturers develop systems, identify risks, and create SOPs so they could receive lubrication certification.

Today, the NSF oversees a food lubrication evaluation program. It’s basically what the USDA designed, which requires manufacturers producing lubrication for food processing applications to deliver supporting documents that prove health and safety compliance.

What does this mean for lubricant manufacturers and operations that use food-grade lubricants? Essentially, there are layers of compliance, required systems, and sets of checks and balances that must be adhered to for the sake of public health.

Common Lubricants Used in Food and Beverage Manufacturing

H1 Lubricants

H2 Lubricants

H2 lubricants can be used in food and beverage manufacturing facilities but not in applications where contact with food is a possibility. There is no defined list of ingredients that H2 lubricants must contain, but there are ingredients that cannot be present in food processing areas, such as:

• Carcinogens
• Mutagens
• Teratogens
• Mineral acids
• Heavy metals like arsenic, lead, and mercury

H3 Lubricants

H3 lubricants are edible or soluble oils generally used for cleaning and preventing rust on machine parts. They are typically composed of oils from corn, cottonseed, soybean, or minerals. While H3 lubricants can be used in contact with food, they are limited by FDA regulations. 

What Makes a Lubricant Food Grade?

The FDA specifies the components that food-grade lubricants must be made of to safely have incidental contact with food. Lubricants that are NSF-certified as food-grade and achieve the FDA’s zero-tolerance standard are listed as NSF-certified non-food compounds.

Food-grade lubricants are safe for use in meat, poultry, and other food processing equipment and applications.

The FDA Codes in Title 21 explain what ingredients are allowed in food-safe lubricants. For example, H1s are more limited because they are allowed for incidental exposure with foods. H2 guidelines are less restrictive and include a broader selection of lubricants, yet they still meet governing guidelines and require manufacturers to have compliance protocols in place, as with any lubricant.

Food-grade lubricants are:

• Odorless
• Tasteless
• Rated safe for incidental exposure
• Capable of withstanding extreme cold and hot temperatures
• More stable than traditional mineral and white oil-based food-grade lubricants

In addition to complying with stringent regulatory standards, food-grade lubricants also have been shown to extend equipment life and reduce maintenance costs.

Regulations 101: Understanding Your Responsibilities

There are many moving parts in food and beverage processing equipment. The lubricants used to grease bearings, chains, gearboxes, and other machine components can potentially drip, leak, mist, or otherwise “touch” a product that consumers will eventually eat or drink. Every step of the production process can include some potential hazard.

Food and beverage manufacturers have a responsibility to ensure safe, reliable manufacturing - and this accountability is mandated by the FSMA. SOPs must be in place to ensure FSMA compliance, guided by Hazard Analysis and Critical Control Points (HACCP) and Hazard Analysis and Risk-Based Prevention Controls (HARPC).

What is the Food Safety Modernization Act?

According to the Centers for Disease Control and Prevention (CDC), every year, foodborne illness and disease in the United States causes:

• 1 in 6 Americans (roughly 48 million people) to get sick
• 128,000 hospitalizations
• 3,000 deaths

The Food Safety and Modernization Act (FSMA) is designed to dramatically change the way we identify and prevent foodborne illness in the global food system. It acknowledges foodborne illness as a significant threat to public health and the economy. It also emphasizes that food safety is a shared responsibility, and every player in the supply chain must be held accountable by putting defined protocols and procedures in place to prevent contamination.

The FSMA gives the FDA enforcement authority to promote compliance and encourage risk-based food safety standards. That way, when an exposure occurs, there are plans for a timely and effective response to help contain the problem.

In the Know: Implementing FSMA

There is quite a bit of confusion surrounding FSMA and hazard systems such as HACCP, and misunderstandings about what the regulations require can put a food and beverage manufacturer at risk of non-compliance.

“Not understanding” FSMA will not excuse a processor from audits, fines, and penalties. Because FSMA covers a broad scope of industries and manufacturers, some that might not think their facilities require food-safe lubricants could unknowingly be violating the law.

Here are some FSMA requirements and steps that will help manufacturers be compliant:

• All plants must have a food safety plan that is documented and developed with a preventive controls-qualified individual trained by an FDA partner.
• Manufacturers should designate someone as the FDA liaison to assist with inspections.
• A lubrication program must list all steps in the manufacturing process.
• Manufacturers must assess the severity of every listed potential hazard.
• The risk of listed hazards must be weighed against the benefit to explain why they exist in the process.
• Risks must be limited with documented controls that are put in place.
• Controls must be proven to be effective to prevent a hazard from occurring.
• The entire process must be on record and produced on demand for an FDA inspector.

What are HACCP and HARPC?

HACCP is a system to help stop hazards in food production, and it includes seven principles:

1. Hazard analysis
2. Critical control point identification
3. Establishment of critical limits
4. Monitoring procedures
5. Corrective actions
6. Record keeping
7. Verification procedures

HARPC is a hazard analysis provision of the FSMA that was created to identify potential risks of contamination to food and ingredients in processing, manufacturing, packaging, and holding. Every hazard must be identified, evaluated, prevented, monitored, and corrected.

Because of the regulations outlined by the HACCP and HARPC, which are necessary for complying with FSMA, food and beverage manufacturers are responsible for shouldering a significant burden in developing airtight SOPs. Essentially, there is zero tolerance for contamination.

What does all this have to do with food-grade lubricants? The right lubricant must be assigned to each application in the manufacturing process, and those food-safe lubricants must meet FSMA requirements. Otherwise, a manufacturer is at significant risk of threatening public health, losing consumer confidence, footing the costs of recalls, and inhibiting the facility's ability to continue operations.

Overcoming Challenges: Safely Lubricating Food Processing Equipment

Unlike other industries, the food and beverage processing industry faces unique circumstances that can pose hazards to food safety when it comes to lubrication. These conditions can create challenges for facilities when lubricating their food processing equipment.

Lubricant Qualities: A food and beverage processing facility must choose the appropriate lubricant before anything is lubricated. The right lubricant must withstand extreme conditions, such as heat, cold, water, steam, and oxygen, and offer effective pumpability. Additional considerations must be met depending on where the lubricant will be used, in accordance with federal guidelines.

Machine Parts: Because of the complex range of manufacturing equipment a food and beverage facility can require, one facility can have a unique mix of components that all require proper lubrication. This includes pumps, mixers, tanks, chain drives, and conveyor belts.

Internal Surfaces: Beyond lubricating critical machine parts, food and beverage processors also use lubricants for internal surfaces to control factors like heat and corrosion.

Systems and SOPs: Defining Processes

Selecting the right food-grade lubricants and putting required hazard prevention and SOPs in place will prevent potential risks and exposures. And, in today’s environment, no food processor can afford to take shortcuts with training and process implementation.

Where to Start?

To develop a lubrication program in line with FSMA standards that will reduce liability and help protect public health, there are several action items a facility should perform. 

1. Identify every step in the manufacturing process.
2. List every potential hazard tied to those steps.
3. Assess each identified hazard to determine the associated risk of contamination in terms of probability and severity.
4. Weigh the risks versus benefits of each step and the probability of severe hazards to determine what is critical and what isn't.
5. Ensure appropriate controls are in place across the entire operation to limit the overall risk of contamination.

In pursuit of zero accidents, zero defects, and zero failures, the Japanese Institute of Plant Maintenance (JIPM) developed its Total Productive Maintenance (TPM) concept. Because lubrication is critical to ensuring safe, effective food and beverage production, TPM is an effective strategy for covering all the bases of plant management to reduce risk. A plan should address HACCP, and all employees should understand processes.

While developing a training program and staying compliant with FSMA might seem overwhelming, it begins by listing every step in the manufacturing process. Assemble the team, refer to a plant diagram, outline every step in the production process, and then break down those steps into machines and specific components that require lubrication.

While doing so, keep in mind what “hazard” means in the food processing arena as it relates to food-grade lubricants. Any situation that could compromise the integrity of a food product or ingredient is considered a potential hazard. By including a range of individuals involved in manufacturing processes, more intelligence about potential hazards can be compiled and reviewed.

Identifying potential risks is the foundation of establishing SOPs and training.

Below are additional tips for creating procedures to ensure lubricants are used properly, safely, and in compliance with FSMA and FDA requirements.

• Perform a site survey to help assign an appropriate food-safe lubricant to every component that requires one.
• Seek out NSF registration to ensure that lubricants are suitable for use in food and beverage processing.
• Outline specific SOPs and identify who (an individual or team) in the organization will be held accountable for each step.
• Test and monitor the controls put in place.
• Ensure that the maintenance plan meets HARPC requirements.

Take the Guesswork Out of Training

Food and beverage processors are not alone in their pursuit of achieving FSMA compliance, properly selecting lubricants, and developing maintenance plans.

From learning precision lubrication skills to maximizing machine reliability to analyzing lubricants for use in food processing, an experienced training partner can lift the burden so manufacturers can focus on production and profitability.

Noria offers a Food Processing Equipment Lubrication course that outlines the FSMA, how it impacts food processors’ lubrication program and lubricants used, and how to develop a risk-based prevention control plan that will ensure compliance.