On OSHA’s latest regulatory agenda, the agency noted it would complete the required SBREFA report for a draft rule on beryllium in January 2008, and it did (121-page PDF here) This report stems from the December 6 meeting between OSHA, the Small Business Administration and small entity representatives, as required by the Small Business Regulatory Enforcement Fairness Act .  This 1996 law requires OSHA (and EPA) to share a draft of proposed regulations to a group of small business owners (i.e., companies with 500 or fewer employees) so they can suggest changes to it or to the agency’s preliminary economic analysis.  The comments, recommendations and resulting changes to the pre-proposed rule are documented in a SBREFA report. 

I highlight below some of the items I found most interesting in the report.

For background, beryllium is an extremely light-weight but strong metal.  It was used during the Cold War as an essential component in development of our nuclear weapons, and is now used in other applications.  It is highly toxic and capable of causing an acute or chronic form of beryllium (respiratory) disease and cancer.

The 14 “small entity representatives” (SERs) on the SBREFA panel on beryllium  came from 11 different States and were involved in precision metals, precious metal recycling, medical optics, bushing and bearing production, metal stamping, and dental alloys.  I learned that one beryllium alloy is used in sprinkler heads.  Allegedly, no other material will work for these sprinkler components.  (I find that hard to believe.)

In the documents reviewed by the SERs, OSHA states it is considering a permissible exposure limit for beryllium as low as 0.1 ug/m3 (down from the current PEL of 2.0 ug/m3.)  Through this process, OSHA found out that all these firms

“reported very low exposure in their establishments and industries—relative to the proposed PELs.  …The SER that was most extensively involved in processing beryllium reported average exposures below the lowest PEL option of 0.1 micrograms per cubic meter.  This SER and another had internal PELs of 0.2 with action levels of 0.1 micrograms.”

Well, well, that’s pretty interesting to hear that this assembly of companies was already achieving a 0.1 ug/m3 exposure limit.  So, complying with an improved OSHA regulation should not be difficult, right?

Not exactly.  The report continues:

“As a consequence, unlike most OSHA health standards where the challenge to employers is achieving a PEL far below the current exposures and the subsequent cost of engineering controls, many SERs viewed the impact of a beryllium standard on their establishment mainly via the ancillary provisions (e.g., showers, change rooms, housekeeing, etct.)”

So, which one of those pesky ancillary provisions do they dislike the most? 

The medical surveillance provisions of the draft proposed rule.  These provision are designed to help determine if workers have been sensitized to beryllium, a potential precursor to chronic beryllium disease.  The SBREFA report notes the proposed medical surveillance provisions were “the most controversial part of the draft standard for most SERs, and received the most comment.”

“Three SERs whose daily operations have the potential for higher exposure to beryllium provide the BeLPT for the employees.  One of the SERs with over 200 employees has provided the BeLPT for many years, but noted that they stopped doing the tests annually because it was expensive and found to be unnecessary by their medical advisers.  They now offer the test every two years and have focused their physical exams more narrowly as well.  In their written comments, the SER suggested permitting performance-based medical surveillance; that is, allowing affected employers to design and determine what tests were appropriate. (Speedring/Axsys Technology)  This SER has discontinued annual physicals, xrays and spirometry and instead perform symptom-based exams.”  

Isn’t waiting for symptoms a little late?   

“The SERs articulated concerns with the cost of the test, the accuracy of the test, what to do with the results, what to tell employees, what to do with employees who test positive, the impact on workers compensation costs, the potential for lawsuits, the impact on employee (insurance and future employability), the ability to hire employees, the damage to their ability to compete in the global market, particularly against China”

Sounds to me like some good reasons to find a substitute for beryllium.  Let’s not forget our hierarchy of controls–and at the top, if appropriate, SUBSTITUTION for a less dangerous material.

“A number of SERs said that OSHA lacked evidence of beryllium disease in their industry, or even exposure.  SERs from the stamping industry, for example, said that they had never had of  case of beryllium-related disease associated with their industry.  They suggested that OSHA should prove the existence of the hazard in each industry prior to regulating.  One SER noted that although there were 40,000 employed over many years in his industry, a few cases of beryllium disease was insufficient justification for a standard that would impose significant costs and might disrupt the industry.”

How exactly do these business people know there have never been cases of beryllium-related disease in their industry?  Have they ever seriously looked?

Two other themes that emerged in the SBREFA report and employers’ comments were “material impairment” and carcinogenicity.  

One SER (Ditron) said:

“OSHA should not use beryllium sensitization as a material impairment of health or as criteria for promoting rule requirements.”

I’ve heard before this “material impairment” argument from representatives of Brush Wellman,  the “leading global supplier of beryllium alloys” in 2003 (here) during a Cal/OSHA rulemaking on beryllium.

I agree that the OSH Act directs the Secretary to promulgate standards so “that no employee will suffer material impairment of health or functional capacity,” (6(b)(5))  but no where does it say that material impairment is only defined by “clinical symptoms.” 

OSHA’s report notes that some of the small business representatives are disturbed by the notion of labeling beryllium as a carcinogen.  

“One SER questioned the appropriateness of identifying beryllium as a carcinogen, which would require appropriate labels on products.  The SER said that concerns about beryllium causing cancer is an artifact of twenty years ago when exposures were ten times as high as today.”

I can’t find the term “artifact” in the company’s actual comments; may be the OSHA authors’ interpretation of what they heard from the business representative.  This particular SER (Ditron) goes on:

“OSHA should remove the cancer warnings from signs and labels based on the most recent scientific evidence.  OSHA did not seek comment on its intent to require products supplied by the SERs would have to be labeled with a cancer warning.  I attempted to raise this concern that such a requirement is not justified considering exposure potentials that exists today and that having such warnings would unnecessarily scare customers and employees.”

Unfortunately, the commenter did not elaborate on the “most recent scientific” but last time I checked, the International Agency for Research on Cancer (in 1994) and the U.S. National Toxicology Program (in 2002) have both designated beryllium as a human carcinogen.   The claim is not knew to us.  The beryllium industry insists that beryllium is not a carcinogen, and they often tout their most recent scientific evidence which is comprised of re-analyses of other researchers’ work.

Now that OSHA has completed this SBREFA process, the next step will be actually proposing the beryllium rule.  Stay tuned to the Secretary of Labor’s next regulatory agenda (expected in May) for an indication of when the proposed rule may be issued.