NIOSH Scientific Information Quality - Peer Review Agenda
NIOSH Method 7704: Beryllium by field-portable fluorescence (air)
Peer Reviewers’ Comments and NIOSH Response:
Note: The two NIOSH Methods, "Method 7704: Beryllium in Air by Field-Portable
Fluorometry", and "Method 9110: Beryllium on Surfaces by Field-Portable
Fluorometry", were reviewed jointly because they are so similar in most respects,
particularly from an analytical standpoint. That was the case for both the web-based
public comment opportunity, and the invited expert reviewers. As a result of this joint
review, the following comments and responses address both methods.
Comments were received from 5 selected reviewers and the public on the two proposed
NIOSH methods and associated backup data report that summarizes validation tests.
A single blind study using beryllium metal and beryllium oxide spiked samples was used
to verify that an independent laboratory could produce similar acceptable results.
Comments concerning test source materials were received from two reviewers. There is
no NIST Standard Reference Material (SRM) for beryllium oxide, so commonly
available commercial materials were used to validate the method. A reference addressing
particle size and beryllium salt characterization of a beryllium oxide test material, and the
use of beryllium oxide spikes in quality control testing have been included as suggested.
However, inclusion of a general beryllium salts or beryllium silicate recovery discussion
were not included since the focus of the research is the recovery of the most commonly
encountered workplace beryllium compounds (beryllium metal and beryllium oxide).
Several comments were received concerning the airborne exposure and surface
contamination limits. The methods now cite two categories of exposure standards: U.S.
regulatory occupational exposure standards and other published limits and guidelines. In
the first category, applicable OSHA, MSHA and U.S. Department of Energy (DOE)
limits have been listed. These limits have undergone formal rule making and public
comment however the DOE limits only apply to DOE facilities and DOE contractors.
Other non-mandatory limits include the guidelines established by three U.S. occupational
health organizations (the American Conference of Governmental Industrial Hygienists
[ACGIH], the American Industrial Hygiene Association [AIHA] and NIOSH). As
suggested, the methods now state "not established" when OSHA, MSHA, DOE, ACGIH,
AIHA or NIOSH have not established a limit or guideline. Three exposure limit data
bases are cited and limits established by over 30 countries and provinces are included.
One comment suggested that more detailed information concerning skin sensitization
should be included. While skin sensitization is an important issue, the backup data report
continues to focus on beryllium analytical issues, not beryllium health related issues.
One comment suggested that additional information or research should be included
concerning surface sampling. Surface sampling uptake rates are important for all wipe
sampling. However the focus of the research has been on analytical performance. If
additional research on beryllium wipe sampling uptake rates becomes available, it can be
included in a future revision of the method.
All other comments were minor technical or editorial comments that were included in the
Required Elements for Initial Posting
Title: NIOSH Method 7704: Beryllium by field-portable fluorescence (air)
Subject: New or updated method in a collection of methods to sample and analyze workplace contaminants.
Purpose: To conduct air monitoring in the field in order to determine compliance with existing U.S. and European beryllium exposure standards. Exposure to beryllium can cause chronic beryllium disease and beryllium sensitization.
Timing of Review: July 2006
Primary Disciplines or Expertise Needed for Review: Chemistry, industrial hygiene
Type of Review: Individual
Number of Reviewers: 4
Reviewers Selected by: NIOSH
Public Nominations Requested for Reviewers: No
Opportunities for Public to Comment: Yes
Peer Reviewers Provided with Public Comments Before their Review: No
Dr. Melecita M. Archuleta
Organizational Affiliation: Industrial Hygiene Analytical Chemistry Lab, Sandia National Laboratories
Area of Expertise, Discipline, or Relevant Experience: Inorganic chemist and toxicologist, with many publications on beryllium.
Mr. Mike Brisson
Organizational Affiliation: Laboratories, Westinghouse Savannah River Co.
Area of Expertise, Discipline, or Relevant Experience: Chemist with expertise in waste management and field sampling of beryllium.
Ms. Brandi Duran
Organizational Affiliation: Actinide, Catalysis, & Separations Chemistry, Los Alamos National Laboratory
Area of Expertise, Discipline, or Relevant Experience: Analytical chemist who is an expert in sampling (surface & soil) of inorganic compounds
Dr. Gary E. Whitney
Organizational Affiliation: Los Alamos National Laboratory
Area of Expertise, Discipline, or Relevant Experience: Area of expertise: industrial hygienist who is an expert in beryllium evaluation and control.
Charge to Peer Reviewers:
Dear Dr. Archuleta:
I understand from NIOSH Manual of Analytical Methods (NMAM) editors that you may be willing to review two NIOSH methods for the NIOSH Manual of Analytical Methods (NMAM):
"NIOSH Method 7704: Beryllium by Field-Portable Fluorescence Measurement"
"NIOSH Method 9110: Beryllium by Field-Portable Fluorescence (wipes)"
Thank you for your willingness to do this review. I am attaching a total of seven documents to this email, a simple review form, the two methods documents themselves, a backup data report, and a quality assurance report for each method. You may also know that the documents, except for the quality assurance report, have been posted on the web for comment at the URL link http://www.cdc.gov/niosh/review/public/nmam-7704-9110/.
Methods proposed for publication in NMAM have a backup data report and quality assurance review report. The backup data report contains additional information on the proposed method's development and performance evaluation that is not included in the proposed method. The quality assurance report is an internal NIOSH review of the proposed method's performance including a user check where a laboratory not involved with the method's development uses the method. The purpose of the user check is to verify that an independent laboratory can obtain comparable results and can correctly follow the method. Normally, the quality assurance report is not posted on the web site for public comment, but we feel it is important for you to have it available for your review.
Your comments on the proposed methods are very important to us. In addition you may comment on the supporting data contained in backup data report or internal quality assurance review reports as you see fit.
To document our review, I will need a summary of your professional background and expertise. This could be provided in the form of a biosketch, or even a CV, if that is easiest. I will also need a statement from you regarding conflicts of interest by completing the attached conflict of interest form. Please be advised that T. Mark McCleskey (Los Alamos National Laboratory [LANL]) has filed a patent, and Berylliant, Inc. has licensed the technology used in NIOSH 7704 and 9110. Therefore affiliations with McCleskey, LANL and Berylliant, Inc. as well as affiliations with CDC and NIOSH that you may have should be disclosed on the attached conflict of interest form. Please be advised that conflicts of interest (real or perceived) do not preclude you from participating as a reviewer, but must be disclosed.
Please send your review directly to me, by email at firstname.lastname@example.org or by regular mail at the address shown below. We would appreciate receiving your comments by July 25, 2006. If you would like to review the methods, but need additional time, please let me know that in advance of the due date. I realize that schedules are more variable during the summer.
We will consider all comments received through the web comment process, but your specific review is of particular importance to us in meeting our objectives for a careful review by subject matter experts. Your review will be handled separately from the comments we receive through the web posting. If you have any questions about this matter, please do not hesitate to contact me by phone at (513)841-4143, or by e-mail.
Thank you again for your help in our efforts to prevent work-related illness and injury. I look forward to receiving your review.
W. Gregory Lotz, Ph.D.
Captain, U.S. Public Health Service
Associate Director for Science
Division of Applied Research and Technology
CDC/National Institute for Occupational Safety and Health
4676 Columbia Parkway
Cincinnati, OH 45226
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