ERG Task Order No. 0193.15.080.001

TECHNICAL CHARGE AND INSTRUCTIONS TO PEER REVIEWERS

Peer Review of OSHA’s Preliminary Health Effects Section for Beryllium

You have been selected to participate in an external peer review of the
OSHA preliminary health effects section for beryllium that will be part
of a proposed rule that would amend the existing regulation for
occupational exposure to beryllium.  The health effects section includes
a discussion of the adverse effects that result from beryllium exposure
and the evidence that supports those associations.   The health effects
section is not a quantitative risk assessment, but rather the primary
analysis upon which the Agency must rely when making its determination
that employees exposed to beryllium at the current permissible exposure
limit (PEL) face a significant risk of material impairment to their
health and that the proposed standard will substantially reduce that
risk.  The quantitative risk assessment is based on a subset of the
health endpoints and studies discussed in the health effects section. 
The quantitative risk assessment is discussed in another section, which
you are also reviewing under this task, addressing a different set of
charge questions.

In the discussion of the health effects and their association with
beryllium exposure, the interpretations of studies and conclusions drawn
should be reasonable, sound, and consistent with the underlying science.
  The overriding goal of the peer review is to ensure that the
presentation of the studies, interpretations of the study results, and
preliminary conclusions drawn are clear and scientifically credible. 
OSHA has provided the following questions to guide and focus your review
divided into two types: 1) general questions that apply to all parts of
the health effects section; and 2) specific questions that apply to
individual sections/topics in the health effects section of the proposed
rule.  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

General

The draft health effects section reviews and summarizes a number of
studies.  Are the studies described in sufficient detail for the reader
to understand how the studies are relevant?  Are the descriptions of the
studies and results accurate?  Are the strengths and limitations of the
studies appropriately addressed?  Are the interpretations of the studies
reasonable and adequately explained?   If no, what needs to be added to
improve the information and how should it be presented?

The draft health effects section covers a selection of studies for each
health endpoint and does not attempt to cover every study ever published
on each of the endpoints.  Are there additional studies of
importance/significance that should be included in this review that were
missed?  Are there specific health endpoints that should be included in
this review that were missed?

The draft health effects section contains conclusions for each section. 
Are these conclusions reasonable with regards to the information
available to OSHA at the time of this review?  

Introduction Section on Beryllium and Beryllium Compounds

Is OSHA’s review of beryllium and the particle/chemical
characteristics helpful to the reader in understanding the biological
effects of beryllium?

Are the kinetic studies described in enough detail to understand
absorption, distribution, metabolism, and excretion of beryllium and its
compounds?

Beryllium-Induced Respiratory Disease Section

Is acute beryllium disease described in sufficient detail?  Are there
any significant studies missed in this review?

Has the role of particle size, form of beryllium, dermal contact, and
genetic susceptibility in the development of beryllium sensitization and
chronic beryllium disease (CBD) been adequately characterized?  

Is the development and progression of CBD from sensitization accurate,
clear and understandable?  Are there any significant studies or other
information which should be included in this review?

Are the definitions of beryllium sensitization and chronic beryllium
disease clear, understandable and reasonable? Does the scientific
evidence indicate that beryllium sensitization be considered an early
endpoint in the development/progression of CBD? Should beryllium
sensitization be considered a condition/risk factor necessary for the
development of CBD?

Is the format and presentation of studies understandable?  Is there a
better format for presentation of this complex information?

Are the preliminary conclusions reasonable and well presented?  Is there
convincing evidence from the occupational studies that beryllium
sensitization and CBD prevalence are exposure-related such that
reductions in exposure will lead to reduction in immune sensitization
and reduction in the occurrence of chronic disease?  Is there convincing
evidence from animal studies that lung burden is an important dose
metric for the development of the Be-immune specific granulomatous
lesions?  

Beryllium-Induced Lung Cancer Section

Is the mechanism of inflammatory-induced carcinogenicity a reasonable
mechanism for beryllium and beryllium compounds as laid out in OSHA’s
review of the scientific literature?  Are there other mechanisms or
modes of action equally as plausible?   

Other Health Effects

Are there other health effects that should be considered in this review?
 If so, what are the studies?

Accessing References

You may access all reference materials on ERG’s FTP site (see attached
instructions), which are filed in the Health Effects 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 MONDAY, SEPTEMBER 13, 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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