1. AIHA Carolinas Section -- Spring Conference
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

2. Overview Some background on TLVs®. How TLVs are developed.
The legal challenges of 2001.
Where do we go from here?

3. What is ACGIH®? Membership Society Neutral on Public Positions
Multi-disciplinary
Core membership from government & academic institutions
Neutral on Public Positions
No programs in credentialing, job placement, or associated business services

4. 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

5. TLVs® and BEIs® Threshold Limit Values for Chemical Substances
Threshold Limit Values for Physical Agents
Biological Exposure Indices for Chemical Substances

6. Selected Milestones in the History of TLVs/BEIs
Committee established.
First list published.
Notice of Intended Changes published.
Begin to develop Documentation for each TLV.
First Edition of Documentation published.
TLV Committee for Physical Agents appointed.

7. Selected Milestones in the History of TLVs/BEIs
Committee guidelines and procedures approved and published. Updated in 1987, 1989, 1992, 1994, 1998, 2001
BEI Committee appointed
Bylaws and conflict of interest policy revised to allow expanded voting privileges
Litigation defense (3 cases)

8. 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

9. 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.

10. 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.

11. Critical Health Effect Basis for TLVs
TLV Basis - Critical Effect Percent
Irritation
CNS effects
Respiratory effects
Liver effects
Blood effects
Kidney effects
Skin effects
Cancer
Sensitization
All other effects

12. TLV Documentation 7th Edition issued in 2001 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

13. TLV-CS Committee Membership
Occupational
Hygiene
Toxicology
Occupational
Medicine
Epidemiology

14. TLV-CS Committee Structure

15. TLV Development Process
Under Study
List
Draft
Doc.
Comm. Review
& Revision
External
Input
Comm. Review
& Revision
Comm. & Board
Approval
NIC
Comm. & Board
Approval
Adopted
Value

16. The Essential Ingredients for Developing TLVs/BEIs
Published / Peer-Reviewed Science +
Dedicated Volunteerism
Professional Integrity & Judgement

17. 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.

18. 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

19. 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

20. Impacts of the Lawsuits
ACGIH
Financial
Insurance coverage
Indirect and opportunity costs
Volunteer Service
Misinformation and Misperceptions
Lobby efforts to “reform” ACGIH

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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

28. 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.