For many years, the United States Department of Agriculture’s Food Safety and Inspection Service Division (USDA/FSIS) reviewed the formulations of maintenance and operating chemicals, including lubricants, for use in official meat and poultry establishments that operate under USDA inspection. This Prior Approval Program, as it came to be known, was the industry standard for determining food-grade lubricants. The USDA/FSIS “List of Proprietary Substances and Nonfood Compounds” was the standard reference for food-grade and nonfood-grade lubricant for food and beverage processors worldwide. It listed lubricants in categories labeled H-1, H-2, H-3 and P-1.
USDA Food-Grade Lubricant Categories
True food-grade, USDA H-1 authorized lubricants are compounds that are permitted on equipment where food may potentially be exposed to the lubricated part of the machine. These instances are referred to by the USDA/FSIS as incidental contact.
USDA H-2 authorized lubricants, usually containing nontoxic ingredients, may be used in food-processing plants on equipment in locations where there is no possibility of the lubricant or lubricated part of the machine to contact edible products.
The USDA H-3 category refers to water-soluble oils. The machined part has to be cleaned and free of the emulsion before reuse. Finally, the USDA P-1 category refers to lubricants that are used in accordance with the conditions established by the USDA’s letter of acceptance. These lubricants should not be used in a food or beverage processing plant.
The USDA/FSIS made its determination about lubricants based on the various Food and Drug Administration (FDA) Codes in FDA Title 21 (see sidebar). There are five codes in FDA Title 21 that dictate approval for ingredients used in lubricants that may have incidental contact with food.
The USDA/FSIS’ Prior Approval Program for Proprietary Substances and Nonfood Compounds was effective. It served as a watchdog for the lubricants industry and protected the consumer against harmful substances that had the potential to contaminate food and beverage products.
Elimination of the Prior Approval Program
In February 1998, an official announcement published in Federal Register1 said the USDA/FSIS was eliminating the Prior Approval Program. It pointed to the evolution of Hazard Analysis Critical Control Point (HACCP) programs in which biological, chemical and physical hazards had to be monitored by food and beverage processors and both FDA and USDA inspectors. Lubricants are a potential chemical hazard in HACCP programs. It also estimated that between $150,000 and $187,000 in USDA administrative costs could be saved by eliminating the Prior Approval Program. There were no fees involved for manufacturers who submitted their products for potential USDA authorization. If the USDA/FSIS had charged a fee for product submission, it may have eliminated some of the administrative costs, at the same time perhaps preventing the submission of products which were not manufactured with FDA-compliant ingredients.
In addition to HACCP compliance, one of the solutions suggested by the USDA/FSIS was for users of food-grade lubricants to seek “letters of guarantee” from their suppliers, which would certify that the lubricants used were manufactured with FDA Title 21-approved ingredients.
The elimination of the Prior Approval Program left the international lubricants industry in a quandary. There was a defined requirement for food-grade lubricants in HACCP plans, for instance. Lubricant manufacturers knew that food-grade lubricants must be manufactured with FDA Title 21-approved ingredients in order to eliminate them as potential chemical hazards in HACCP programs. But what organization could then serve as the industry watchdog to ensure compliance?
Three organizations came forth with plans for food-grade lubricant authorization and monitoring: The National Sanitation Foundation (NSF), Underwriters Laboratory (UL) and a joint working group from three lubricant industry professional associations: The National Lubricating Grease Institute (NLGI), The European Lubricating Grease Institute (ELGI) and the European Hygienic Equipment Design Group (EHEDG).
NSF Food-Grade Authorization Program
The NSF, an internationally respected, nonprofit consumer products monitoring organization, developed an authorization program that mirrors the USDA/FSIS program and is guided by Title 21 of the FDA’s Code of Federal Regulations. NSF registration is a formal procedure that reviews the lubricant formulations and certifies that they are in compliance with the various FDA Title 21 regulations. Once products are registered, the lubricant manufacturer may use the NSF-registered logo in its promotional literature and trade advertising.
Another important feature of the NSF’s program is that formulations and products are continually monitored for effectiveness. In the USDA/FSIS system, lubricant manufacturers were on the honor system to resubmit products if there were formulation modifications. However, there are fees for NSF evaluation and registration so the manufacturer is responsible for making sure that its products are formulated with FDA Title 21-approved ingredients. Product submissions cannot be whimsical because of the justifiable fees involved. Lubricant consumers may gain easy access to the NSF’s registered lubricants and chemicals list by logging onto its Web site www.nsf.org/usda/listings.asp. Like the USDA/FSIS designation, the NSF designates food-grade lubricants, those lubricants approved for incidental contact, as NSF/H-1 registered.
Underwriters Laboratory has not been aggressive in defining its lubricants and chemicals authorization program, although it has organized several informational meetings inviting lubricant and chemical manufacturers to attend.
The NLGI/ ELGI/ EHEDG Joint Food-Grade Lubricants Working Group has been active in drafting an authorization program for food-grade lubricants. Like the NSF, the Group’s program mirrors the former USDA/FSIS authorization program, and the ingredients used to manufacture food-grade lubricants must be FDA Title 21-approved compounds. The Group’s plan is to obtain a German Government-sanctioned DIN standard and then use the DIN standard as a basis for an ISO (International Organization for Standardization) standard. The Group also acknowledges the importance of HACCP programs which call for the use of FDA ingredient-compliant H-1 food-grade lubricants that eliminate lubricants as a potential chemical hazard.
Technological Advancements in Food-Grade Lubricants
Equally important as industry monitoring are the continued technological developments in the formulations of H-1/food-grade lubricants which must provide lubrication protection for food and beverage-processing machinery worth hundreds of thousands of dollars. Both petroleum-based and synthetic lubricants are available to effectively do the job.
F.D.A. CODES (CFR) - Exhibit A
F.D.A. Codes (CFR) Which Affect Lubricants for Machinery with Incidental Food Contact
21.CFR 182 With 9 Subheadings
Petroleum-based H-1/food-grade lubricants are developed with either technical white mineral or USP-type white mineral oil. United States Pharmacopoeia-designated (USP) mineral oils are the purest of all white mineral oils, and are the most oxidation stable, providing optimum lubrication when compared with all other white mineral oils. FDA-compliant ingredients are added to the formulation to increase antiwear capabilities, improve oxidation resistance and prevent rust and corrosion.
Synthetic H-1/food-grade lubricants available are primarily polyalphaolefin (PAO)-based fluids. They provide significant oxidation resistance versus petroleum-based H-1 food-grade oils. They also provide significantly better cold temperature operating capability. In combination with food-grade additives, PAO-based food-grade H-1 fluids are outstanding lubricants for air compressors, oil recirculating systems, hydraulic systems and gear reducers. Their initial high costs are generally justified by their long-range performance.
Polyalkylene glycol-based H-1 food-grade synthetic fluids are becoming popular for applications where temperatures exceed 400°F (204°C) up to 600°F (316°C). Bearings, chains and gear reducers subjected to these temperatures are candidates for polyalkylene glycol H-1 fluids.
H-1 food-grade greases may be either petroleum-based or synthetic. Aluminum-complex is the most common thickener for today’s food-grade greases, and produces a very shear stable product. Aluminum-complex-thickened greases can also withstand elevated temperatures. They are also highly water resistant, which is vital for food and beverage-processing equipment because of post shift equipment wash downs.
The sidebar displays the relevant FDA Title 21 codes to which all petroleum-based and synthetic fluids and other ingredients must comply.
The most important aspect in the evolution of food-grade lubricant technology is that H-1/food-grade lubricants can now effectively handle every machinery lubrication application at a food and beverage-processing plant. This consolidates lubricant inventory, is good for the food and beverage-processing plant employees and, most importantly, gives added protection to the consumer.