The situation can only get worse, experts warn, as upcoming regulations threaten to restrict the use of certain chemicals even more. And as their choices become more limited, fluid suppliers and manufacturers will be facing higher costs for development and testing – just to be able to stay in the market.

An August 2006 report from Frost and Sullivan, Regulations and Technological Trends in the Metalworking Fluids Market, describes the many regulatory challenges confronting metalworking fluid manufacturers. The report states that meeting these regulations is important for the growth of a chemicals based industry like metalworking fluid manufacturing. Companies able to meet these restrictions gain a definite advantage over those which are not.

John Burke, director of engineering services at Houghton International, Valley Forge, Pa., observes, In the U.S. alone, fluid formulators must take into account at least 10 environmental and OSHA regulations concerning chemical exposure issues.

More importantly, he adds, water and air emissions regulations are enforced regionally rather than nationally, so local regulations come into play as well. As a result, says the metalworking industry veteran, users and suppliers must take into account some 30 to 40 regulations, many of which overlap and conflict with one another.(See list, page 30.)

A critical concern is not so much the number of regulations but the lack of consistency in enforcement. We are sufficiently regulated, comments Burke, who is chairing next Octobers Metal Removal Fluids Symposium in Dearborn, Mich. But enforcement can be spotty, and companies are sometimes made examples of when local bodies suddenly decide to enforce regulations.

These headaches are not exclusive to U.S. markets, says Philip Miller, manager of global metalworking additives compliance at The Lubrizol Corp., Spartanburg, S.C. Every country may eventually have its own chemical inventory and rules, notes Miller, with registration and notification philosophies differing from country to country. For example, he says, Canada Challenge is planning to reevaluate 220 substances now on its Domestic Substances List, while Australia is looking at a similar program, and new inventories are starting in China and New Zealand.

Health a Hot Button

While there has been a great deal of activity in environmental regulations, there has not been a whole lot of health and safety regulatory change for the last six or seven years, according to John Howell, safety, health and environmental specialist at D.A. Stuart Co., Warrenville, Ill. That may be about to change. He notes that at the end of 1999, the MWF Standards Advisory Committee (which included labor, industry and public health officials) recommended that OSHA develop a standard that included a personal exposure limit (PEL) for metalworking fluid mist of 0.5 mg per cubic meter. Instead, the agency issued a set of Best Practices that do not have regulatory status.

However, Howell goes on, one thing that could potentially increase fluid regulation is the American Conference of Governmental Industrial Hygienists (ACGIH) recommended Threshold Limit Value for MWFs of 0.2 mg/m3 on oil particulate mist. This recommendation has been out for comment since Spring 2006 and has not yet been acted upon. ACGIH is soliciting further comment, and there remains a possibility that this value will have to reported in Section 2 of fluids Material Safety Data Sheets. Acceptance of the ACGIH recommendation would mean a substantial lowering of current limits.

Dermatitis is the biggest health-related problem for users of MWFs, and its occurrence is likely underreported by both employees and employers. For water-based fluids, an added worry is the growth of so-called Gram-negative bacteria. When these bacteria die, part of their cell wall creates an endotoxin that can cause fever and respiratory distress. Says Howell, Endotoxins are recognized as a significant microbiological component of in-use metalworking fluids. While there is no ongoing effort to regulate the amount of endotoxin in an in-use fluid, people are looking at the role they play in acute respiratory impact. The focus is also on hypersensitivity pneumonitis, which left untreated may lead to permanent lung impairment and possible death.

REACHs Impact

Some industry observers believe that the European Unions Registration, Evaluation and Authorization of Chemicals (REACH) initiative may drive some harmonization of chemical regulations, because data developed for REACH may apply to regulations in other countries. REACH went into effect on June 1, 2007, and is aimed at improving the protection of worker health and the environment.

Richard Kraska of Kraska Consultants Inc., Bonita Springs, Fla., has 27 years experience in regulatory affairs and industrial toxicology. He points out that with the adoption of REACH, the list of chemical substances allowed in products sold in the EU (the EINECS inventory) will be abandoned in favor of a registration process requiring the participation of manufacturers and importers of each chemical.

REACH is complicated, consisting of an 849-page document, seven major implementation projects and 10 specific guidance documents for industry. A further complication is that all staff currently working on REACH is temporary: REACH will be managed by a new agency that has yet to be formed and will be headquartered in Helsinki.

The first step in the process will be the preregistration of chemicals. This relatively easy step will occur in 2008. Actual registration, a more onerous step, will be phased in according to each chemicals usage. Registration of metalworking fluids probably will be due after 2010, according to the following timeline:

High volume or high hazard chemicals – June 2008 to November 2010.

Moderate volume chemicals – November 2010 to June 2013.

Lowest volume chemicals – June 2013 to June 2018.

The later steps of evaluation and authorization will involve consortia of manufacturers of similar products meeting to determine safe working requirements.

Eyeing the impact of REACH on the U.S. MWF market, Kraska concludes that the regulations will be very burdensome. He even contends that sacrificing European sales might make sense for some companies rather than complying with the new regulations. However, it is possible that other countries, customers or groups may also require REACH registration, so complying may be necessary regardless of a fluid suppliers European strategy.

One major consideration for REACH is the global automotive industrys expectations for its suppliers. Automotive companies apparently have not made up their minds yet, but a supplier education webinar is likely to be held in January (see http://www.chemicals policy.org/downloads/Automot iveSectorandREACH.pdf).

The advantages of preregistering cannot be overemphasized, Kraska says. It is a relatively easy process with a rather simple form and no preregistration fees. Companies will, however, need a toxicologists help in filling out the form, and a lawyer with a connection to a European entity is needed to file the paperwork. However, he stresses, the timeframe for preregistration is short, tight and inflexible. Preregistration must be completed between June and November 2008.

How do companies decide if they need to preregister chemicals? First, says Kraska, they need to decide what products must be REACH-compliant, by composing a list of chemicals and sales volumes. Second, they need to know if their suppliers are committed to preregistering and registering. Third, they need to know if they make chemicals because inadvertent mixtures may not be exempt from registration.

A good example of this is salts formed in metalworking fluid reactions, notes Lubrizols Miller. Formulators must determine if the salts are incidental or intended, and whether or not they must comply. Right now, REACH provides no clear guidance on these issues. The situation is similar for boric acid salts, especially the amine salts. The proposed Boron Initiative addresses these materials, but has not yet been implemented.

The registration process for REACH will be very complex, laborious and expensive – and likely to be logjammed, says Kraska. There are not enough toxicologists and lawyers to do all the work required for the tens of thousands of chemical substances that must be registered. Every chemical to be registered requires a person sitting on a committee to work on registration documents. In addition, registration fees will be significant, and a consensus dossier will be required for each chemical as well as a consensus chemical safety report, test plan and hazard classification.

Kraska notes that a major sticking point of REACH is that companies relying on importers to register their products may have to submit detailed formulation information – information that lubricant manufacturers traditionally do not want to divulge. Also, after registration, suppliers will be required to submit a dossier to authorities and make annual updates. This may result in an erosion of confidential business intelligence throughout the process.

Industry Responds

Industry response to REACH has taken several different courses. For example, to assist companies in complying with REACH and other foreign chemical controls, the American National Standards Institute (ANSI) and the National Association of Manufacturers (NAM) have established a Manufacturers Network on Chemical Regulation. This group will link manufacturers and trade associations in a broad range of industries affected by chemical regulations. Because an immediate concern is to help companies comply with REACH, the network sponsored an experts meeting on REACH implementation in October 2007. More information on this forum is available by emailing Brian Meincke bmeincke@ansi.org at ANSI, or by calling (212) 642-4940.

The Frost & Sullivan report cited above notes that environmental and safety restrictions have already been imposed on some chlorinated paraffins, nitrites, alkanolamines and formaldehyde-release biocides because they are potentially carcinogenic. (For more on formaldehyde biocides, see Debunking the Myths about Formaldehyde Condensates and Metalworking Fluids, LubesnGreases, December 2006.)

In addition, legislation requires that the base oils used to make oil-based MWFs be tested for carcinogenic components. Biocides have also been restricted because they can cause dermatitis, pulmonary problems and eye irritation.

In response to these restrictions, industry has been active on the formulation front. Lately, D.A Stuarts Howell notes, concerns about the environmental impact of biocides have led to the development of new fluid chemistries that provide an unfriendly environment for bacteria. The fluids are based on a variety of raw materials, particularly dicyclo hexyl amine (DCHA) in combination with other amines.

DCHA does not act as biocide to kill bacteria; it just does not offer a good growth environment. However, some controversy surrounds these fluids because DCHA by itself is aggressive, causes skin burns and is highly toxic. But its toxic effects are ameliorated when it is combined with other chemicals. All types of metalworking fluids can be formulated with DCHA. The question is how effective they are in the field, and whether the health risks are lower than for conventional fluids.

According to Houghtons Burke, another response to the new regulations has been the development of long-life fluids that are safer for workers and the environment. Also, he sees a trend by fluid users to very low or near-zero discharge levels. Users increasingly recycle their oily wastewater or send it to third-party handlers to avoid discharge regulations. They then recover the oil by-products for reuse.

This has given rise to another business opportunity for MWF suppliers, says Burke. Fluid users do not want to be in the water treatment business. Therefore, they are increasingly asking their fluid suppliers to provide waste treatment services. Cradle-to-grave-to-cradle management of fluids is the next progression of fluid management, adds Burke, and the responsibility has fallen back into the lap of the chemical manufacturer.

The Independent Lubricants Manufacturers Association has also responded to its members needs by developing the Metalworking Fluids in Small Business: A Health and Safety QUICKSTART Guide, in partnership with OSHA. It is meant to help small businesses and their employees manage the health, safety and environmental impacts of metalworking fluids.

The guide, which is available at www.ilma.org, outlines how to work safely with MWFs and includes links to websites where shops and small businesses can get more detailed safety information.