Date: Mon, 24 Dec 2007 14:09:16 -0800
Reply-To: Larry Gibbs <lgibbs**At_Symbol_Here**STANFORD.EDU>
Sender: DCHAS-L Discussion List <DCHAS-L**At_Symbol_Here**LIST.UVM.EDU>
From: Larry Gibbs <lgibbs**At_Symbol_Here**STANFORD.EDU>
Subject: Re: Help with How Standards are Developed.
Comments: To: fwblack
In-Reply-To: <000901c84671$218bd4c0$2cb35c45**At_Symbol_Here**your4dacd0ea75>
Neither NIOSH nor ACGIH develop "standards."  

For more information on the ACGIH process for developing "occupational
exposure guidelines" for chemical agents, physical agents and for Biological
Exposure monitoring, see http://www.acgih.org/TLV/PosStmt.htm , some of
which is posted below.  

Larry (I am also incoming Chair if ACGIH as of January 1, 2008)
Lawrence M. Gibbs, CIH
Associate Vice Provost for EH&S
Stanford University
480 Oak Road
Stanford, CA  94305-8007
650.723.7403

TLVR/BEIR Resources 

----------------------------------------------------------------------------

Statement of Position Regarding the TLVsR and BEIsR 
The American Conference of Governmental Industrial Hygienists (ACGIHR) is a
private not-for-profit, nongovernmental corporation whose members are
industrial hygienists or other occupational health and safety professionals
dedicated to promoting health and safety within the workplace. ACGIHR is a
scientific association. ACGIHR is not a standards setting body. As a
scientific organization, it has established committees that review the
existing published, peer-reviewed scientific literature. ACGIHR publishes
guidelines known as Threshold Limit Values (TLVsR) and Biological Exposure
Indices (BEIsR) for use by industrial hygienists in making decisions
regarding safe levels of exposure to various chemical and physical agents
found in the workplace. In using these guidelines, industrial hygienists are
cautioned that the TLVsR and BEIsR are only one of multiple factors to be
considered in evaluating specific workplace situations and conditions. 

Each year ACGIHR publishes its TLVsR and BEIsR in a book. In the
introduction to the book, ACGIHR states that the TLVsR and BEIsR are
guidelines to be used by professionals trained in the practice of industrial
hygiene. The TLVsR and BEIsR are not designed to be used as standards.
Nevertheless, ACGIHR is aware that in certain instances the TLVsR and the
BEIsR are used as standards by national, state, or local governments. 

Governmental bodies establish public health standards based on statutory and
legal frameworks that include definitions and criteria concerning the
approach to be used in assessing and managing risk. In most instances,
governmental bodies that set workplace health and safety standards are
required to evaluate health effects, economic and technical feasibility, and
the availability of acceptable methods to determine compliance. 

ACGIHR TLVsR and BEIsR are not consensus standards. Voluntary consensus
standards are developed or adopted by voluntary consensus standards bodies.
The consensus standards process involves canvassing the opinions, views and
positions of all interested parties and then developing a consensus position
that is acceptable to these parties. While the process used to develop a
TLVR or BEIR includes public notice and requests for all available and
relevant scientific data, the TLVR or BEIR does not represent a consensus
position that addresses all issues raised by all interested parties (e.g.,
issues of technical or economic feasibility). The TLVsR and BEIsR represent
a scientific opinion based on a review of existing peer-reviewed scientific
literature by committees of experts in public health and related sciences. 

ACGIHR TLVsR and BEIsR are health-based values. ACGIHR TLVsR and BEIsR are
established by committees that review existing published and peer-reviewed
literature in various scientific disciplines (e.g., industrial hygiene,
toxicology, occupational medicine, and epidemiology). Based on the available
information, ACGIHR formulates a conclusion on the level of exposure that
the typical worker can experience without adverse health effects. The TLVsR
and BEIsR represent conditions under which ACGIHR believes that nearly all
workers may be repeatedly exposed without adverse health effects. They are
not fine lines between safe and dangerous exposures, nor are they a relative
index of toxicology. The TLVsR and BEIsR are not quantitative estimates of
risk at different exposure levels or by different routes of exposure. 

Since ACGIHR TLVsR and BEIsR are based solely on health factors, there is no
consideration given to economic or technical feasibility. Regulatory
agencies should not assume that it is economically or technically feasible
for an industry or employer to meet TLVsR or BEIsR. Similarly, although
there are usually valid methods to measure workplace exposures at TLVsR and
BEIsR, there can be instances where such reliable test methods have not yet
been validated. Obviously, such a situation can create major enforcement
difficulties if a TLVR or BEIR was adopted as a standard. 

ACGIHR does not believe that TLVsR and BEIsR should be adopted as standards
without full compliance with applicable regulatory procedures including an
analysis of other factors necessary to make appropriate risk management
decisions. However, ACGIHR does believe that regulatory bodies should
consider TLVsR or BEIsR as valuable input into the risk characterization
process (hazard identification, dose-response relationships, and exposure
assessment). Regulatory bodies should view TLVsR and BEIsR as an expression
of scientific opinion. 

ACGIHR is proud of the scientists and the many members who volunteer their
time to work on the TLVR and BEIR Committees. These experts develop written
Documentation that include an expression of scientific opinion and a
description of the basis, rationale, and limitations of the conclusions
reached by ACGIHR. The Documentation provides a comprehensive list and
analysis of all the major published peer-reviewed studies that ACGIHR relied
upon in formulating its scientific opinion. Regulatory agencies dealing with
hazards addressed by a TLVR or BEIR should obtain a copy of the full written
Documentation for the TLVR or BEIR. Any use of a TLVR or BEIR in a
regulatory context should include a careful evaluation of the information in
the written Documentation and consideration of all other factors as required
by the statutes which govern the regulatory process of the governmental body
involved. 

ACGIHR is a not-for-profit scientific association. 
ACGIHR proposes guidelines known as TLVsR and BEIsR for use by industrial
hygienists in making decisions regarding safe levels of exposure to various
hazards found in the workplace. 
ACGIHR is not a standards setting body. 
Regulatory bodies should view TLVsR and BEIsR as an expression of scientific
opinion. 
TLVsR and BEIsR are not consensus standards. 
ACGIHR TLVsR and BEIsR are based solely on health factors; there is no
consideration given to economic or technical feasibility. Regulatory
agencies should not assume that it is economically or technically feasible
to meet established TLVsR or BEIsR. 
ACGIHR believes that TLVsR and BEIsR should NOT be adopted as standards
without an analysis of other factors necessary to make appropriate risk
management decisions. 
TLVsR and BEIsR can provide valuable input into the risk characterization
process. Regulatory agencies dealing with hazards addressed by a TLVR or
BEIR should review the full written Documentation for the numerical TLVR or
BEIR. 
 

ACGIHR is publishing this Statement in order to assist ACGIHR members,
government regulators, and industry groups in understanding the basis and
limitations of the TLVsR and BEIsR when used in a regulatory context. This
Statement was adopted by the ACGIHR Board of Directors on March 1, 2002. 

Policy Statement on the Uses of TLVsR and BEIsR
NIOSH, a government funded entity, develops and publishes RELs or
Recommended Exposure Levels.  

-----Original Message-----
From: DCHAS-L Discussion List [mailto:DCHAS-L**At_Symbol_Here**LIST.UVM.EDU] On Behalf Of
fwblack
Sent: Monday, December 24, 2007 1:08 PM
To: DCHAS-L**At_Symbol_Here**LIST.UVM.EDU
Subject: [DCHAS-L] Help with How Standards are Developed.

Folks - I know in general how NIOSH and ACGIH generates their standards.
However, I recently had a question asked of me for more detail.  Is there
any place that I can go to get the general synopsis?

 

Frankie Wood-Black, Ph.D., REM, MBA

  fwblack**At_Symbol_Here**cableone.net

Senior Air Professional

Trihydro Corporation

 

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