acgih’s role in the development of exposure assessment guidelines for occupational hygiene scott...
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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
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Overview
• Some background on TLVs®.
• How TLVs are developed.
• The legal challenges of 2001.
• Where do we go from here?
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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
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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
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TLVs® and BEIs®
• Threshold Limit Values for Chemical Substances
• Threshold Limit Values for Physical Agents
• Biological Exposure Indices for Chemical Substances
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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.
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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)
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TLVs Defined
“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.”
TLV
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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.
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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.
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Critical Health Effect Basis for TLVs
TLV Basis - Critical Effect PercentIrritation 30.4CNS effects 12.0Respiratory effects 8.8Liver effects 8.7Blood effects 6.4Kidney effects 4.7Skin effects 3.8Cancer 3.7Sensitization 2.8All other effects 18.7
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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
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TLV-CS Committee Membership
OccupationalHygiene
OccupationalMedicine
Toxicology
Epidemiology
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TLV-CS Committee Structure
Staff
Subcom m ittees --Substance Selection
N otationsM em bership , etc.
S taff Assistants
D ust & InorganicsSubcom m ittee
(D & I)
H ydrogen, O xygen, C arbonSubcom m ittee
(H O C )
M iscellaneous C om poundsSubcom m ittee
(M ISC O )
TLV Full C om m ittee(S teering C om m ittee)
AC G IH B oard ofD irectors
AC G IH M em bership
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TLV Development Process
Under StudyList
DraftDoc.
Comm. & BoardApprovalNIC
Comm. Review& Revision
External
Input
AdoptedValue
Comm. Review& Revision
Comm. & BoardApproval
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The Essential Ingredients for Developing TLVs/BEIs
Published / Peer-Reviewed Science
+
Dedicated Volunteerism
+
Professional Integrity & Judgement
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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.
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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
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Legal Issues• Free Speech (First Amendment)
– ACGIH’s Right to Publish
• Federal Advisory Committee Act– ACGIH is a Private Professional Society and not a Quasi-
Governmental Organization
• Deceptive Trade Practice & Product Defamation– Economic harm
• Due Process– TLVs/BEIs are not developed using a consensus process– Perceived promises & conflicts
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Impacts of the Lawsuits• Financial
– Insurance coverage– Indirect and opportunity costs
• Volunteer Service
• Misinformation and Misperceptions– Lobby efforts to “reform” ACGIH
ACGIH
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.