EPA Slaps Behnke for Antimicrobial Claims


Behnke Lubricants will pay a $55,055 penalty to the U.S. Environmental Protection Agency for violations of federal pesticide rules because of antimicrobial claims made in marketing and labeling of the companys Jax brand food-grade lubricants.

The case began with a hearing in Waukesha, Wis., in March 2007, and concluded with a Chicago administrative judge ruling in favor of EPA Region 5 on Dec. 30 last year. The agency announced the ruling publicly on Thursday.

We took the thing to court to try to get a decision one way or the other based on our viewpoint of how the regulations handle these types of lubricants, Behnke president Eric Peter told Lube Report. Basically we got in trouble because wed done our testing on E.coli, listeria and salmonella, and we said it was effective against those; they said you cant do that unless we [EPA] have our say-so on it.

According to the judges decision, Menomonee Falls, Wis.-based Behnke sold or distributed five Jax-branded lubricants (Poly-Guard FG-2 and FG-LT; Halo-Guard FG-2 and FG-LT, and Magna-Plate 74) that EPA deemed to be unregistered pesticides.

EPA registers all pesticides and pesticide products under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The agency considers disinfectants, antimicrobials and antibacterial products to be pesticides.

Out of respect for the recent EPA decision that our past labeling created a need for EPA registration, we are presently working with EPA to achieve full compliance, Peter said in a Feb. 2 letter to Jax customers. In the interim, Behnke will refrain from labeling or promotion that may be construed as violating the EPAs regulations.

He said the company cooperated with the EPA and the Wisconsin and Minnesota Departments of Agriculture in their investigation, which the company said focused on labels and literature it distributed. We also attempted to correct the concerns with our labeling and literature pending a ruling on the EPAs position, he said. Behnke never denied its action or its claims, but rather espoused a differing interpretation of the relevant regulations.

Peter said the issue in the case boiled down to whether Behnke could rely on its customers and independent laboratory tests to support antimicrobial claims on its labels and promotional materials. The EPA concluded that such testing was insufficient to prove efficacy for purposes of the EPAs regulations, but did not pass judgment on whether or not the testing was flawed or inaccurate, he said. Nor was the safety of the Jax products in issue. All Jax FG-H1 lubricants have been, are and will remain in compliance with the ingredient and formulation standards of the FDA and USDA [Food Safety and Inspection Service].

While the products are not registered, public-health pesticidal claims would have to be removed, EPA spokesman Terence Bonace told Lube Report. If a product is registered as a pesticide, label claims that can be made for the product concerning antimicrobial properties and public health will be determined in the registration process.

Behnkes Website describes the company as a full-line industrial lubricant manufacturer with special emphasis on lubrication for food-, beverage- and drug-processing plants.

We undertook an effort to inform our customers – the food-processing and beverage-processing industry – of these benefits, Behnkes Peter said. At no time were these claims made to the consuming public at large. We believe and argued that our customers are sophisticated enough to determine through their own laboratory and field testing the effectiveness of our products for their intended applications.

The EPA ruling didnt come as a surprise to Fred Passman, president of consulting firm Biodeterioration Control Associates in Princeton, N.J. Passmans firm provides consulting in microbial contamination control.

The EPA action is precisely what Ive been warning food-grade lubricant manufacturers about for the past five to eight years, when Behnke first started making claims that their chain lubes had antimicrobial properties, Passman told Lube Report. A number of food-grade lubricant compounders asked me for recommendations.

He recalled advising them of two significant legal issues at that time. One was that compounders at that time had no options. There were a variety of food preservatives that had NSF H1 listings, but werent registered as antimicrobial pesticides under FIFRA (40 CFR 152), and there were a couple of possible FIFRA-registered products that didnt have the requisite NSF H1 listing, Passman said. (NSF is a nonprofit organization that registers lubricants for food-grade applications.) There were no products that had both, he went on. Consequently, there were no antimicrobial pesticides – microbicides – that could be used legally as preservatives in food-grade lubricants.

Since then though, Passman noted, Petro Canada has obtained FIFRA registration for using Microl preservative (benzoic acid) in food-grade lubes; and Lanxess has successfully registered its Preventol CMK (p-metalchlorocresol, or PCMC) antimicrobial with NSF as an ingredient for food-grade lubes.

Now that two microbicides have achieved both required registrations – NSFs food-grade registration plus the FIFRA nod — the issue of sites comes into play, Passman continued. Under FIFRA registration, products are approved for use in one or more sites. A site is a specific application (e.g. metalworking fluids, lubricants, fuels, etc.) and a targeted pest (e.g. bacteria, fungi, rodents, etc).

This means that a microbicide approved in a lubricant against bacteria and fungi is the product for which the performance claim is permitted, Passman continued. FIFRA regulations do not permit compounders to extend that claim to their finished products. In other words, unless the compounder obtains FIFRA registration for the finished lubricant, they may not make antimicrobial performance claims for that product.