Additives

Biocides Under a Microscope. U.S.

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For more than a century, metalworking fluids formulators and users have dosed their coolants with antimicrobial agents to hold down the growth of bacteria, fungus, mold and yeast. Allowing such organisms to get a foothold and colonize the fluid can lead to serious health problems for workers, as well as vile odors, increased corrosion, clogged filters, ruined parts and – when the bugs get completely out of control – a need to dump the coolant and start fresh. Whether you cal them biocides, microbicides, antimicrobials or preservatives, hundreds of these active ingredients have been used in metalworking, including such standbys as orthophenylphenol (OPP), triazine, isothiazolinone, sodium omadine and amines.

This is an intensely regulated area, and more so every year, points out Fred Passman of the Princeton, N.J., research and consulting firm BCA Inc. At last months annual meeting of the Society of Tribologists and Lubrication Engineers in Philadelphia, Passman joined a panel discussing the rising tide of antimicrobial and pesticide regulations around the world. Moderator for the May 8 event was toxicologist Richard Kraska, of Kraska Consulting in Bonita Springs, Fla., and panelists represented the U.S. and Canadian governments, a chemical industry trade group, the independent registrar NSF International, and a Washington, D.C., law firm specializing in regulatory affairs.

Passman opened the session with a quick review of metalworking fluid microbicides, beginning with the use of parachlorometaxylenol (PCMX) in Germany in the 1880s. Not much later, in 1901, phenolics such as OPP were introduced, followed in 1924 by triazine. In the early 1940s, 3-hydroxyphenols were developed, and the 1970s and 1980s saw a proliferation of new actives, including alkanolamines and tris-hydroxy, Passman recounted.

Regulators were along at almost every step, beginning with the U.S. Federal Insecticide Act of 1910, and Federal Insecticide, Fungicide and Rodenticide Act (the original FIFRA) of 1947. An updated FIFRA was passed by Congress in 1972, and the 1980s brought even more stringent rules about product testing, data and labeling. This scrutiny greatly reduced the field of participants, as unsupported products exited the market. Before then, more than 2,000 active substances were in use as antimicrobials, including nearly 200 for metalworking fluids, Passman said; afterward, only about 80 microbicides for metalworking were left.

Meanwhile, in Canada the Pesticide Management Registration Act ordered strict oversight of biocides in the 1980s, and most recently, Europes Biocide Products Directive (BPD) clamped down even more, putting the burden on sellers to show that their antimicrobials do not pose health hazards in the way they are used. PostBPD, all biocides sold in the EU must have approvals, Passman said. Manufacturers who committed to supporting their biocides with testing and data had until September 2006 to list them with the EU, and until the end of this month (June) to provide documentation. All other products had to leave the market.

However, most companies chose not to register, so the number of available products is dropping, Passman said. While biocides for large-volume applications such as pool chemicals and water treatment undoubtedly will be supported by their makers, the relatively small world of metalworking fluids is going to see its choices reduced, he predicted. Its all about the movement of cash. We in the metalworking fluid industry are orphans of orphans of orphans.

A Chip of the Market

The microbicide industry is a $6 billion to $10 billion business, and a generous estimate would be that $120 million of that goes into metalworking – that is, only 1.2 percent of the market, Passman later told LubesnGreases. The major microbicide companies want to see a market greater than or equal to $100 million per product before theyll take on a new project. So the market opportunity in metalworking fluids is right at the border of that go/no-go decision.

The cost of regulatory compliance is climbing rapidly, agreed Betty Shackleford of the U.S. EPAs Office of Pesticide Programs. The data requirements for making claims about biocides are spelled out in 40 CFR Part 158, Pesticide Licensing and Registration, the microbiologist pointed out. It now costs about $5 million to register a new chemical – on top of the applicants own research and development costs – and the antimicrobial industry often cant afford this, Shackleford said.

While FIFRA is the overarching framework for the U.S. governments control of pesticides, other laws also apply, such as 1996s Food Quality Protection Act, which ordered EPA to look again at all pesticides registered prior to November 1984 to ensure they meet current standards. Effective Oct. 10, 2006, this law also requires that all chemicals undergo a fresh review every 15 years.

Shackleford pointed to another rule, enacted in February 2006, which requires EPA to set up a Human Studies Review Board to weigh the scope, ethics and merits of every study involving humans. This will add time and cost to many biocide applications.

The Pesticide Registration Improvement Act, PRIA, meanwhile let EPA establish a fee for service, so that registrants pay fees that cover about 40 percent of the agencys cost to review a chemical. The good news is that the PRIA also affords industry timelines, Shackleford added. Previously, the tendency was to put the most difficult reviews at the bottom of the stack, where they might never get done. PRIA provides the resources, the fees, to get the review done.

All these registrations, reviews, testing and data may seem endless, she acknowledged. Some might ask, Is all this data needed? Our answer is that we need all the data we can get. Were mostly an agency of scientists, and the more data we have, the better we understand. So we want data on toxicity, on human exposure, on product chemistry, residue, dietary exposure, etc. It all helps us determine what needs to be put on the product label.

What Goes in Canada

Jason Dubois of Health Canadas Pesticide Management Regulatory Agency said there are currently 12 active ingredients and 53 end-use products registered as metalworking fluid antimicrobials in Canada. PMRAs authority stems from Canadas Pest Control Products Act, which aims to prevent unacceptable risks, and also is supposed to ensure than only products of acceptable value are used, he said.

Its OK to bring in a treated article (the metalworking fluid) into Canada, but not the biocide itself if its not on Canadas list. Users may import a metalworking fluid containing a non-Canadian-registered biocide, but cannot buy that same biocide and use it tankside, he indicated.

Next, scientist Hasmukh Shah of the American Chemistry Councils Antimicrobial Exposure Assessment Task Force described a $10 million study undertaken by the 60 member companies of ACCs Biocides Panel. This research, initiated in 2003 to meet the data needs of U.S., Canadian and European regulators, covers 17 application methods and two application sites, as end-uses are called: metalworking fluids and wood pressure treatments. The plan is to generate exposure data on antimicrobial products, including toxicity studies, a cancer study and worker exposure monitoring data.

Shahs task force is seeking typical medium to small metalworking shops to participate in the field study. These must be willing participants, Shah emphasized, with both workers and management under no coercion to join in. Were hoping for locations with 15 to 20 workers and that use open or semi-open machines. There would be a stable active ingredient in the fluid, and its desirable to have a variety of machine processes represented.

The original plan was for the ACCs study to take four years, then one more year to address the data, wrap up the work and issue the final report. Now with the additional requirement for review by the Human Study Review Board, that planned timeline has been delayed, he said. We will get there, but the road just got longer. Our original $10 million budget just got more expensive too, and will probably run to $15 million because of the added requirements.

Products that have been on the market for many years now face new costs for new data to re-register, Shah remarked, and going forward, every 15 years you will have a new review, so the expense going forward to maintain registrations will be high. We also expect to see new fees, as labels and claims will have to be EPA-approved.

Product 13

Yet more difficulties are expected in Europe, where the Biocide Products Directive defined 23 product types to be regulated as active substances, including disinfectants, preservatives, pest control agents, insecticides and antifouling agents, explained Mike Novak, an attorney with law firm Keller and Heckman LLP. Product type number 13 turns out to be antimicrobials used in metalworking fluids. Hope that isnt unlucky, Novak wryly pointed out.

New actives, those not on the market before May 2000, cannot be sold now until theyre listed on Annex I of the Biocides Products Directive, he continued.

The directive has two levels of registration: identified products, which were simply listed, and notified products for which the manufacturers committed to do testing, submit data and pursue the whole approvals process. Only products on the notified list now are allowed to go forward. All the identified products had to be removed from the EU market by September 2006, Novak reminded. Industry was unable to support all of them, and some were simply dropped. Citronella candles, for example, were not picked up.

Treated articles, such as fluids containing a biocide, are not subject to the Biocides Products Directive, as long as they make no external effect or public health claim. For example, a preserved metalworking fluid would not be covered – but the active ingredient going into it is covered, Novak stressed. You cannot import the active substance if its not on the notified list, but you can import the treated article; that is, the fluid.

Jennifer De France of NSF International in Ann Arbor, Mich., also addressed the issue of antimicrobials, which are covered in the nonprofit organizations voluntary registration program for nonfood compounds. Many lubricant companies are familiar with NSFs registration program for H1 and H2 food-grade lubricants, but it also registers antimicrobial products meeting FIFRA. These fall into NSF categories D1 and D2 for antimicrobials; F1 to F5 for pesticides; and Q3, Q4 and Q6 for shell egg sanitizers.NSF also reviews claims on antimicrobial product labels, to ensure compliance with regulations.

A preservative is a type of pesticide, because the function is to protect the article from bacteria, De France pointed out. Examples of claims for preservatives include inhibits growth of bacterial odors and guards against degradation from microorganisms.

What the Label Claims

The issue of what can and cannot be claimed on labels or in promotional statements dominated the remainder of the panel discussion, as participants tried to parse what claims might be legitimate and which are out of bounds. Shackleford pointed to guidance at the EPA website, which spells out claims that cannot be made. (http://www.epa.gov/PR_Notices/pr2000-1.pdf)

Novak reiterated that in Europe, the treated article is not subject to the Biocide Products Directive, if the claim is limited to the internal effect – to protecting the metalworking fluid – and not trying to claim external effects (protecting the workers or equipment). However, metalworking fluids that are not subject to the BPD are still going to come up against Europes other new rule for chemicals, he cautioned. Theres still no free ride around REACH.

Passman expects to see more cracking down on gray areas, such as the use of unregistered microbicides or claims that some metalworking fluids are biostable. Such boasts will fade under the pressure to register these products as microbicides and show supporting data, he predicts. He also seethes at promises that biocide-containing food-grade lubricants can cut down on bacterial growth in food processing and packaging lines; unless the fluids themselves are registered as microbicides for that specific use, he said, these are illegal claims being made, and that will be ended.

EPAs Shackleford stressed, You cannot make a claim (that a product is antimicrobial) unless a product is registered for that use and site [application]. The exception, she said, is a treated article, such as a fluid which contains a microbicide or mildewcide intended to protect that fluid and is registered for that use.

Claims that some fluids are biostable are even dicier. They are not typically what we see in implementing the FIFRA labeling regulations, and we have to look at them on a case-by-case basis. But nine times out of 10 youre going to run into difficulties, the EPA official warned.