Assuring food safety in food processing: The future regulatory environment for food-grade lubricants

Lubrication Engineering, Feb 2002 by Raab, Michael J

Technical Paper

Regulatory changes in the food industry affect the food-grade lubricant market of the future. The U.S. Department of Agriculture (USDA) Food Safety and Inspection System (FSIS) - in conjunction with the Food and Drug Administration (FDA) - long maintained a system of oversight by granting "prior authorization" for lubricants intended for use in food-processing facilities. In September 1998, USDA eliminated this authorization program and instituted the requirements of a Hazard Analysis and Critical Control Point (HACCP) system instead. This paper will discuss various initiatives within the industry to develop an alternative system of authorization and will assert that "third-party certifiers" will dominate in the future food-grade lubricant marketplace.

KEYWORDS

Lubricants; Food-Grade Lubricants; Food Industry Tribology; Environment and Safety; Hygiene; Cleanliness

INTRODUCTION

The processing of agricultural or animal substances into consumable food products is performed in a multifunctional manufacturing plant. Such processing includes one or more operations such as: cleansing, sterilizing, homogenizing, blending, mixing, stirring, freezing, chilling, baking, frying, cooking, cutting, slicing, packaging, canning or bottling. Large scale food processing is often done with machinery and support components such as: pumps, mixers, tanks, hoses and pipes, chain drives, and conveyer belts. Such machinery and associated support equipment contains mechanical or moving components. Hydraulic fluids, greases, gear and chain lubricants, and other oils are required to ensure reliable and efficient operation of these components.

While good engineering design can reduce the likelihood of adulteration of the food by these lubricants, a myriad of operating constraints and tradeoffs (economic, engineering, logistics, hygienic practice, quality assurance, applicable regulations, and others) tend to increase the contamination risk. Therefore it is essential that those lubricants that may incidentally contact the food product be physiologically safe.

Until February of 1998 (Wholesome Meat Act, (1967), Wholesome Poultry Products Act, 91968), Agriculture Handbook, (1979), Federal Register (1998)), the United States Department of Agriculture (USDA), Food Safety Inspection Service (FSIS) maintained a command and control system aimed at assuring minimal risk to the consumer from incidental or unintended contact. This system also implemented various FDA regulations. Under this system lubricants that were authorized by the USDA were rated as Hi for "incidental contact," H2 for "no contact," or H3 for "soluble oils." These authorized lubricants appeared on the USDA List of Authorized Proprietary Substance under Part II titled "Nonfood Compounds Used In the Plant Environment." (See United States Department of Agriculture, Food Safety and Inspection Service, (1995) and Appendix I).

New USDA regulations have shifted the burden of assessing risk. Implementation of those regulatory requirements are defined by "Hazard Analysis and Critical Control Point" procedures (HACCP), HACCP is a comprehensive guideline to control risks to the food; biological, toxicological and foreign materials. These regulations make the food processor (manufacturer) responsible for the proper selection of lubricants. However, the lubricant manufacturer and/or the equipment supplier (or OEM), still remain responsible for the composition and effectiveness of the lubricant.

HACCP requires the food processor to perform an assessment of each point in the operation at which contamination might occur. Implicit in this assessment is the need for the food processor to know and understand the physiological risk that a lubricant may pose. Such an analysis may require the processor to review and approve the chemical composition of the lubricant. Prior to February 1998, the USDA performed that review role.

Response within the Lubricants Industry

Because the HACCP regulations may require disclosure of confidential and/or proprietary formulation details, some in the lubricants industry sought alternative methods of compliance. Various trade and technical organizations with the lubricants industry have responded to the changing regulations and to the needs of the lubricant manufacturer.

Response of Other Industries and Organizations -- Potentials for the Lubricants Industry

Other industries, such as the manufacturers of cleaners and sanitizers, were also affected by these regulatory changes. Industry trade groups, such as The International Sanitary Supply Association (ISSA), are responding to these changes in regulations. Published papers and talks give ideas, guidelines and options to aid the lubricants industry. The Independent Lubricant Manufacturers Association (ILMA) maintains a Government Relations Committee that seeks to keep its membership informed on the rules and regulations affecting them. From these organizations the author learns that there are essentially three options available to the industry to replace the USDA regulations: do nothing, provide certifications to individual customers, or provide a third-party certification.