Transcript ACGIH’s Role in the Development of Exposure Assessment

ACGIH’s Role in the Development
of Exposure Assessment Guidelines
for Occupational Hygiene
Scott E. Merkle, CIH
AIHA Carolinas Section -- Spring Conference
Charlotte, NC March 13-15, 2002
Overview
• Some background on TLVs®.
• How TLVs are developed.
• The legal challenges of 2001.
• Where do we go from here?
What is ACGIH®?
• Membership Society
– Multi-disciplinary
– Core membership from government & academic
institutions
• Neutral on Public Positions
• No programs in credentialing, job placement,
or associated business services
What Does ACGIH Do?
• Develop health-based occupational exposure
guidelines.
– TLVs and BEIs
• Develop practice guidelines for occupational
hygiene methodology.
– Industrial Ventilation and Air Sampling Instruments
®
TLVs
and
®
BEIs
• Threshold Limit Values for
Chemical Substances
• Threshold Limit Values for
Physical Agents
• Biological Exposure Indices for
Chemical Substances
Selected Milestones in the History of
TLVs/BEIs
1941 - Committee established.
1946 - First list published.
1954 - Notice of Intended Changes published.
1955 - Begin to develop Documentation for each TLV.
1962 - First Edition of Documentation published.
1968 - TLV Committee for Physical Agents appointed.
Selected Milestones in the History of
TLVs/BEIs
1980 - Committee guidelines and procedures approved
and published. Updated in 1987, 1989, 1992, 1994,
1998, 2001
1983 - BEI Committee appointed
2000 - Bylaws and conflict of interest policy revised to
allow expanded voting privileges
2001 - Litigation defense (3 cases)
TLVs Defined
TLV
“Airborne concentrations of
substances and represent
conditions under which it is
believed that nearly all
workers may be repeatedly
exposed day after day
without adverse health
effects.”
Core TLV Principles
• Airborne exposure values for the occupational
setting.
• Health-based values.
Technical, economic, and analytic feasibility is not
considered.
• Not intended for legal adoption; TLVs are not
consensus standards.
Core TLV Principles
• Guidance values to be applied by persons
trained in occupational hygiene.
• The “threshold” concept.
• Established to protect “nearly all” workers.
• Not appropriate for use as index of relative
toxicity.
Critical Health Effect Basis for TLVs
TLV Basis - Critical Effect
Irritation
CNS effects
Respiratory effects
Liver effects
Blood effects
Kidney effects
Skin effects
Cancer
Sensitization
All other effects
Percent
30.4
12.0
8.8
8.7
6.4
4.7
3.8
3.7
2.8
18.7
TLV Documentation
• TLV -- more than just
“THE NUMBER”
• Documentation describes:
– Critical health effects
– Quality of the data relied upon
and areas of uncertainty
– Possible sensitive subgroups
• 7th Edition issued in 2001
TLV-CS Committee Membership
Occupational
Hygiene
Toxicology
Epidemiology
Occupational
Medicine
TLV-CS Committee Structure
ACGIH Membership
ACGIH Board of
Directors
Staff
TLV Full Committee
(Steering Committee)
Subcommittees -Substance Selection
Notations
Membership, etc.
Dust & Inorganics
Subcommittee
(D&I)
Staff Assistants
Hydrogen, Oxygen, Carbon
Subcommittee
(HOC)
Miscellaneous Compounds
Subcommittee
(MISCO)
TLV Development Process
Under Study
List
Draft
Doc.
Comm. Review
& Revision
Comm. Review
& Revision
NIC
Comm. & Board
Approval
Comm. & Board
Approval
Adopted
Value
External
Input
The Essential Ingredients for
Developing TLVs/BEIs
Published / Peer-Reviewed Science
+
Dedicated Volunteerism
+
Professional Integrity & Judgement
Legal Challenges of 2001
In December 2000, ACGIH was named as a
defendant in 3 separate lawsuits -• The “Staples” Case -- Carlin David Staples, et. al. vs.
DOW Chemical Company, et. al.
– ACGIH one of many defendants. Plaintiffs allege
conspiracy to withhold information on hazards of vinyl
chloride exposure.
– Case has been resolved. There are no longer any claims
against ACGIH.
Legal Challenges of 2001
• The “RCFC” Case -- Refractory Ceramic Fibers
Coalition, et. al. vs. ACGIH
– Adoption of TLV for refractory ceramic fibers (0.2
fibers/cc, TWA)
– Settled July, 2001
• The “Trona” Case -- Anchor Glass Container Corp.,
et. al. vs. ACGIH, U.S. DOL, and U.S. DHHS
– Proposed TLV for Trona (sodium sesquicarbonate)
– Settled September, 2001
Legal Issues
• Free Speech (First Amendment)
– ACGIH’s Right to Publish
• Federal Advisory Committee Act
– ACGIH is a Private Professional Society and not a QuasiGovernmental Organization
• Deceptive Trade Practice & Product Defamation
– Economic harm
• Due Process
– TLVs/BEIs are not developed using a consensus process
– Perceived promises & conflicts
Impacts of the Lawsuits
ACGIH
• Financial
– Insurance coverage
– Indirect and opportunity costs
• Volunteer Service
• Misinformation and Misperceptions
– Lobby efforts to “reform” ACGIH
Legal Settlements
• Complete resolution of issues between the parties.
• Some aspects may be confidential.
• No court judgments awarding monetary damages;
All parties paid their own legal expenses.
• Public statements.
• No precedent setting value.
Lessons
• TLVs provide vitally important benchmarks
for occupational exposure assessment.
• The status of TLVs as guidelines - not
standards - is not understood.
• The “3 C’s” of the TLV development process.
OMMUNICATION
• Clearly established procedures for internal and
external communications.
• Publicly available information sources on the
TLV process and how/when interested parties
can have input.
ONFIDENTIALITY
• Preliminary drafts and discussions should stay
within the Committee.
• The TLV and Documentation are products of
ACGIH and the Committee. The identity of
individual authors should be protected.
ONFLICT OF INTEREST
• Conflicts can be actual or perceived.
• Conflicts can range from minor to significant.
• Committee members must declare all potential
conflicts to their peers.
• Actions to protect the process and prevent
conflicts must be consistently applied.
Where Do We Go From Here?
• TLV/BEI Operation Manuals.
– Internal organization and procedures.
• AIHce Forums on TLV/BEI issues.
• TLV/BEI section on the ACGIH website, e.g.:
– NIC and Substances Under Study Lists.
– Procedures and timeframes for communications.
• Statement of Position.
Where Do We Go From Here?
• Specific guidelines on conflict of interest
– Augments current policy
– Addresses relationships involving the Private
sector, Government (regulatory), and Academia
• Retreat on long-range issues
– Resource needs
– Explore the possible role for external peer review &
scientific advisory panels
A Sunrise or Sunset?
• Out-dated OSHA PELs.
• Professional society role in developing
practice guidelines.
• Promises & pitfalls of the consensus process.
• Will future be driven by tort and product
liability?
• Our role in protecting worker health.