Compliance / Global / Best Practices

Dilemmas posed by EU’s REACH legislation

8 recommendations to handle stricter exposure limits

October 1, 2011
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The European Union’s chemical management law known as REACH requires chemical manufacturers and importers to assess risks and describe conditions under which their chemical substances can be safely used. Although REACH is required in Europe, data generated under the law has global impact. Among the data generated for a chemical substance is a Chemical Safety Assessment, Derived No Effect Level (DNEL), Exposure Scenarios, Chemical Safety Report, and extended Safety Data Sheet (eSDS). This article describes my actual encounter with this data and the burden it may place on U.S. business and EHS pros.

An IH job

Earlier this year I was asked to conduct IH monitoring for a client. Among the chemicals to be monitored was a powder used in a brazing operation. The client provided me with the material safety data sheet and other safety information obtained from supplier of the powder to prepare for onsite monitoring. Among the documents reviewed was the chemical manufacturer’s “code of good practice” that described the safe handling practices for the powder.

As an experienced IH, one of my first actions was to check the MSDS and determine the chemical ingredients in the powder. This information helps answer two important questions: 1) What is the method to collect an air sample? 2) What is the exposure limit for the chemical? 

Based on this information and what the client tells me about how the powder is used (e.g. number of employees exposed and controls), I have a good idea if there will be any concerns before sampling is performed. In this case, no problems were anticipated. Based upon my professional judgment, the target PEL and TLV at 4 mg/m3 as an 8-hr. TWA could be easily achieved.

Code of good practice

A few pages into reading the code of good practice I had to put on the brakes and rethink how to approach the monitoring. The code was generated from the manufacturer’s REACH efforts. It listed the DNEL for the powder at 0.14 mg/m3. The code said the DNEL will become the “reference occupational exposure limit.” A DNEL is “the level of exposure above which humans should not be exposed.”

The code also said the mean exposure concentration, based on a minimum of six measurements, had to be less than 10% of the DNEL to be considered “acceptable.”  Between 10% and 100% of the DNEL exposure was “uncertain.” The code was giving a target of nearly less than 0.01 mg/m3 for the powder. That’s some 400 times lower than its current PEL and TLV.

Can’t fault the code

If you are not experienced in industrial hygiene, the code would hold your hand through nearly the entire process to determine if exposure is acceptable. I applaud the code for how well it is written. But as a Certified Industrial Hygienist with my roots here in the U.S., following the letter of the code seems excessively safe. Excessively safe may come at an unnecessary cost and concern. Without the code described, I would have been content in holding the position that exposure at 4 mg/m3 was safe.

Dilemmas

Consider the dilemmas the REACH
data poses: 

  • Chemical manufacturer’s position. When this company generated the data for the powder required by REACH, it was probably told by lawyers it had an obligation to pass the safety information along to all downstream users, even those located outside of Europe.
  • My position as an IH consultant. Can I ignore the information in the code? I can say I believe the data is excessively safe. But I can’t override the safety information in the code.
  • U.S. employer who buys and uses the powder. To achieve the strict exposure limit that’s considered acceptable will require costs that may be unnecessary. Can the employer ignore the code? You may be correct in saying the code is a “guideline” and not the “law” but you know where this may lead – arguments by opposing lawyers.
  •  Employees who may be exposed to the powder. If you tell employees that the definition of a DNEL is “the level of exposure above which humans should not be exposed” can you blame them for wanting exposures to be kept below that level?

I’ve encountered actual REACH information here in the U.S. already. How long before it’s your turn? Soon after OSHA issues its final revised hazard communication standard, the floodgate will open for new safety data sheets required by the globally harmonized standard (GHS), which will likely include a DNEL. Extended SDS information, such as the code just described, may also find its way to you.

Recommendations

Prepare now. I can’t stress the importance of preparation. I wrote about the DNEL in this column back in February 2010. As prepared as I was then, I didn’t expect to actually encounter a DNEL several months thereafter. I thought I had more time.

You need more than just a verbal script to inform a client or boss about REACH and the DNEL. An initial reaction by other parties is to “shoot the messenger.” Get ready to provide a written summary of REACH from other sources.

Brief yourself on how the PEL, TLV, DNEL and other exposure limits are derived. In most cases, and particularly with the DNEL, there may be a huge safety factor built into the number. More than ever, you need to be able to explain this toxicological concept to employees to help them better appreciate that being above a DNEL does not necessarily mean harm will result.

Beef up your IH exposure monitoring capabilities. Predictions are there will be many more DNELs than PELs and TLVs. This means there will be more occasions to conduct IH monitoring.

If you have the qualifications, get the CIH credential. The CIH will help you stand your professional ground in the expected growing debate of how DNELs and other exposure limits should be applied.

Expand your IH awareness to toxicology, biomonitoring methods, skin absorption, risk assessment, and PPE e.g. gloves and respirators. These areas are greatly influenced by REACH and the DNEL.

Although deadlines for compliance may be a couple years out, get a jump on knowing all you can about OSHA’s final hazard communication rule revisions. Look for how OSHA Hazcom and REACH intersect.

Keep an eye out for other EU REACH-like laws. China, for example, now has an EU REACH-like law. TSCA reform at the federal level, whenever it may happen, will influence chemical exposures in the workplace, perhaps in a REACH-like way.

The flow of EU REACH information in the U.S. cannot be stopped. We must apply some of the recommendations now. 

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