ERG Task Order 0193.15.080.001

TECHNICAL CHARGE AND INSTRUCTIONS TO PEER REVIEWERS

Peer Review of OSHA’s Preliminary Quantitative Risk Assessment Section
for Beryllium

You have been selected to participate in an external peer review of
OSHA’s preliminary risk assessment for beryllium.  The risk
assessment will be part of a proposed rule that would amend the existing
regulation for occupational exposure to beryllium.  The risk assessment
is the primary analysis upon which the Agency relies to determine
whether employees exposed to beryllium at the current permissible
exposure limit face a significant risk of material impairment to their
health and whether the proposed standard will substantially reduce that
risk.  It is not meant to include all adverse effects that result from
beryllium exposure.  This risk assessment addresses two related adverse
effects of beryllium exposure, beryllium sensitization and chronic
beryllium disease (CBD).  Other sections of the proposed rule discuss
additional health hazards, including lung cancer, and the evidence that
supports their association with beryllium. 

 

The overriding goal of the peer review is to ensure that OSHA has based
its risk assessment on appropriate publications and data, has clearly
explained its analysis, and has interpreted or analyzed these
publications and data in a manner that is reasonable, sound, and
scientifically credible.  Keep in mind that OSHA’s responsibility is
to protect worker health and the Agency may choose conservative
assumptions where appropriate, and that OSHA is not required to support
its determination of significant risk with quantitative precision or
scientific certainty.  The Agency’s aim is to evaluate the overall
body of evidence to determine whether, based on the currently available
information, it is reasonable to conclude that there is a significant
risk to workers exposed at the current Permissible Exposure Limit (PEL)
and that the proposed PEL will substantially reduce that risk. 

 

OSHA has provided the following questions to guide and focus your review
on issues of importance to the Agency. Your review should, at a minimum,
address each question, providing a discussion and rationale for any
“yes” or “no” responses, and providing other comprehensive
comments to clarify your comments and/or recommendations. .  After the
charge questions, you will find instructions on how to access the
reference materials on ERG’s FTP site.

Charge Questions

 

As the key studies for the preliminary risk assessment, OSHA selected
studies of a beryllia ceramics plant, a beryllium machining facility,
and a beryllium-copper alloy facility because they are facilities with
well-characterized, relatively low airborne beryllium levels, have used
multiple approaches to controlling beryllium exposure, and have used
plant-wide screenings for sensitization and CBD to test the
effectiveness of exposure controls.  Has OSHA clearly and adequately
explained why these were selected as the key studies for the preliminary
risk assessment?  Are there other publications that should be included
among the key studies as a basis of OSHA's risk assessment?  If so,
please identify which additional studies should be included and why they
should be considered key studies for the risk assessment.  In
particular, are there additional studies of sensitization and CBD in
facilities with primarily low (< 0.2 ug/m3) worker exposures and/or
dermal protection requirements, and that have well-documented exposures,
based on full-shift personal lapel samples or other breathing zone
measurements?

OSHA's review of the key studies concluded that the greatest reduction
in risk was achieved when workers' full-shift median exposures for all
processes were reduced to 0.1 ug/m3 or below.  OSHA also observed
substantial risk of sensitization and CBD in facilities where the
highest-exposed processes had median beryllium levels of about 0.2 ug/m3
or higher.  Was OSHA's discussion of the key studies and the logic of
its preliminary conclusions adequately described and clearly
presented?  Were OSHA's preliminary conclusions based on these studies
reasonable and scientifically credible?

Of the three key publications the Agency used to describe risk of
sensitization at very low levels of airborne beryllium exposure, one was
used to characterize risk of CBD at low levels because the other two
were too recent to have extensive follow-up time and did not report the
results of evaluations for CBD.  Are there other publications that
could provide more complete information about the risk of CBD among
workers exposed to airborne beryllium at very low concentrations?  

OSHA’s risk assessment discussed three studies of community-acquired
CBD.  Based on these studies, which included estimates of airborne
beryllium exposure concentrations within the affected communities, the
Agency concluded that individuals who are exposed to airborne beryllium
at very low levels (< 0.1 ug/m3) can develop CBD.  Is OSHA's preliminary
conclusion based on these studies clearly presented and reasonable?  In
particular, is it reasonable to conclude based on these publications
that the cases of CA-CBD reported in these studies resulted from very
low-level beryllium exposure? Are there additional sources of
information on the exposure levels or occurrence of beryllium disease in
these or other affected communities the Agency should consider?

Dermal contact with beryllium has been identified in the scientific
literature   as a likely exposure route for beryllium sensitization. 
Has OSHA’s discussion of sensitization risk adequately addressed the
role of dermal exposure and dermal protection?  Are there additional
studies or data on risk of dermal sensitization the Agency should
include in the preliminary risk assessment? 

OSHA elected to conduct an exposure-response analysis on a dataset
provided by National Jewish Medical and Research Center, collected at a
beryllium machining facility in Cullman, AL.  Was the Agency’s
decision to base an exposure-response analysis on the Cullman, AL
dataset clearly explained and reasonable?  Are there other datasets that
would provide a better basis for exposure-response analysis?  If so,
please identify them and explain why they would provide a better basis
for exposure-response analysis.

To estimate exposures for individual workers in the Cullman, AL dataset,
OSHA’s contractor constructed a job-exposure matrix (JEM) from
industrial hygiene samples provided in the dataset, grouping the data
into time periods based on information about historical conditions at
the plant, and used this JEM in combination with detailed work histories
to estimate beryllium exposure for each worker in the dataset.  A
detailed description of the Agency’s procedure is presented in the
technical companion document, OSHA Cullman risk background.doc,
available at the ERG reference site.  Were the procedures used to group
across time periods and job operations as well as to estimate workers’
exposures adequately described and clearly presented?

OSHA elected to use cumulative exposure to the total mass of beryllium
to quantitatively estimate risk of beryllium sensitization and CBD.   Is
this exposure measure reasonable and appropriate as a basis of
exposure-response analysis for beryllium sensitization and CBD?  Is the
rationale for this choice clearly explained?  Are there other exposure
metrics that would provide a better basis for the exposure-response
analysis?  If so please explain why they would provide a better basis
for the exposure – response analysis and indicate whether there are
datasets available with which to conduct an exposure-response analysis
using these metrics.

OSHA’s contractor used a quartile analysis and statistical modeling
approaches to characterize exposure-response for sensitization and CBD.
A detailed description of the Agency’s procedure is presented in the
technical companion document, OSHA Cullman risk background.doc,
available at the ERG reference site.  Were these analyses adequately and
clearly described?  Were the statistical methods applied correctly
executed, and appropriate to the nature of the dataset and health
outcomes?  Was the derivation of quantitative risk estimates based on
these analyses clearly explained?   Are the risk estimates reasonable?

The preliminary risk assessment identifies and describes several key
areas of uncertainty with regard to the estimates of risk.  Were the
major uncertainties in the risk assessment adequately characterized? 
Were key assumptions in the risk assessment stated and adequately
discussed?  If not, please explain what further discussion should be
included.

Because sensitization and CBD have been shown to occur at exposure
levels well below the current PEL in several occupational cohorts, OSHA
identified these health endpoints as the most appropriate for developing
estimates of risk. On the other hand, the exposure – response data
available for lung cancer mortality have shortcomings that make
quantitative risk assessment for this endpoint less desirable. The
Agency has therefore chosen to analyze workers’ risk of sensitization
and CBD to establish the risk findings for the proposed rule, rather
than the risk of lung cancer.  Is the rationale for this position
reasonable and clearly explained?    

Accessing References

You may access all reference materials on ERG’s FTP site (see attached
instructions), which are filed in the Risk Assessment folder.  Note:
OSHA has become aware of two very recent publications in the Journal of
Occupational and Environmental Medicine that may have bearing on the
occupational risk of beryllium sensitization and chronic beryllium
disease.  One evaluated the effectiveness of an enhanced preventative
program on the prevalence and incidence rate of sensitization at a
beryllium processing plant (Bailey et al., JOEM, 52(5): 505-512, May
2010).  The authors concluded that the preventative program reduced but
did not eliminate beryllium sensitization.  The other publication
presented results from a study of beryllium sensitized workers evaluated
for CBD (Arjomandi et al., JOEM, 52(6): 647-652, June 2010).  The
workers were employed at a nuclear weapons research and development
facility.  This study showed that the worker cohort characterized by
potentially low beryllium exposures and long latency had a low
prevalence of CBD.

Unfortunately, the publications became available while the OSHA Health
Effects and Risk Assessment documents were undergoing the final stages
of internal review and OSHA was unable to incorporate these publications
into their analysis.  However, electronic copies of the articles are
being provided with the other key references for your review and
comment.        

Briefing Conference Call

We will be scheduling a briefing conference call to take place in the
next few weeks during which you will have the opportunity to ask
questions of clarification on the charge and review documents.  OSHA
staff will participate to give a brief overview and background for this
peer review and to answer any questions you may have.

Questions?

Feel free to contact Kate Schalk at 781-674-7324 or Katherine Moore at
781-674-7348 with any questions or concerns.  

WRITTEN COMMENTS ARE DUE TO ERG

NO LATER THAN TUESDAY, AUGUST 31, 2010

REVIEW GUIDELINES

Upon receipt of the review materials, you should have no communications
with members of the public, colleagues or co-workers, OSHA, or other
federal agencies on the materials study under review. If you are
contacted in person or in writing on the peer review by anyone other
than ERG, you should immediately inform Kate Schalk, via email at  
HYPERLINK "mailto:kate.schalk@erg.com"  kate.schalk@erg.com , or via
phone at 781-674-7324. 

If you have any questions on the review materials or need any further
clarification, please contact ERG only and ERG will work with OSHA to
get a reply back to you and the other reviewers.

Your comments will be submitted to OSHA as received (i.e. unedited) and
may be made available to the public. ERG may, however, format your
comments as needed for consistency in the final peer review summary
report.

FORMATTING INSTRUCTIONS

Please prepare your comments addressing the issues and questions as
stated in the Technical Charge, and organize your comments by charge
question. To assist you in preparing your comments, ERG has provided you
with an electronic copy of the Technical Charge via email.

Additional format recommendations are as follows:

TYPE SIZE:	11 point		PAPER SIZE:	8.5" x 11"

SPACING:	1.5 line spacing		MARGINS:	1" margins

Please use a header with your name in the upper right-hand corner of
each page of your comments.

Organize your comments following the order of the charge questions.
Preferably, cut and paste the charge questions into your written
document and write your responses to each question.  If for some reason
you choose not to answer a question, please provide a reason why (e.g.,
question is outside my area of expertise, etc.).   Any comments you wish
to provide not associated with a charge question should be included at
the end of your responses.

Please provide a justification for your response when answering the
Charge Questions. Be as detailed as possible in your responses using
complete sentences.

Remember to spell out acronyms when first used.

Avoid incomplete sentences, abbreviations, and terms that might confuse
the reader.

If you are suggesting any additional references, please provide a full
citation, or electronic copy of the reference (if available).

If illustrations or tables are included, be sure that they are suitable
for reproduction.

Please send your comments electronically as an MS Word 2003 file or
later. If sending them via e-mail, send them to Kate Schalk at  
HYPERLINK "mailto:kate.schalk@erg.com"  kate.schalk@erg.com .  If
mailing a CD, please mail them to: Kate Schalk, ERG, 110 Hartwell
Avenue, Lexington, MA  02421-3136.  Thank you.

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