1. ACGIH ® Structure Scott Merkle, CIH National Institute of Environmental Health Sciences Past-Chair, ACGIH ®

2. Forum on ACGIH ® Exposure Assessment Guidelines Inaugural Forum at 2002 AIHce. Annual forum on ACGIH ® activities to develop occupational exposure assessment guidelines and criteria. Focus of this forum – Current processes for developing TLVs ® for chemical substances.

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

4. What Is ACGIH ® ? Membership Society (founded in 1938) Not-for-profit, Non-governmental Association (501(c)(6) organization) Multi-Disciplinary Membership Traditionally Neutral on Public Positions

5. Membership March 31, 2002 Government & Academia Private Industry & Others

6. Membership by Profession, 2001 Industrial Hygienist42% Administrator/Manager11% OH&S Professional6% Environmental Professional4% Safety Professional3% Other (Engineer, Scientist, Toxicologist, Professor, etc.) ~33%

7. Revenue Sources Technical Publications Other Membership Dues Education 2001 ACGIH ® Statement of Activities

8. Revenue From Technical Publications ($2.2M) 2001 ACGIH ® Statement of Activities TLV ® /BEI ® Book & CD-Rom TLV ® /BEI ® Documentation Ind. Vent. Manual & CD-Rom OEV Guide Bioaerosols Co-Op Sales Other House Pubs.

9. Technical Committees Committees provide the creativity, initiative, and technical expertise that has made ACGIH ® what it is today and what it will be tomorrow..

10. ACGIH ® Committees Committees consist of members, who volunteer time toward developing scientific guidelines and publications –Primary goal is to serve the scientific needs of occupational hygienists –Committee expenses (travel) are supported by ACGIH ® –Time is donated by the members

11. Committees May 2002 Merkle

12. Core Mission May 2002 Merkle

13. Topics of Debate Over the Years The development and sharing of chemical toxicity data (pre- and post- OSHA & TSCA). –TLVs ® based on “analogy” How to assess risks for carcinogenic effects. The (Mis)use of TLVs ® for non- occupational exposures. 1940s - Present 1960s - Present 1980s - Present

14. Topics of Debate Over the Years International “harmonization” of values, or of the underlying definitions and principles. Marshalling the resources needed to support the development of voluntary guidelines. Concerns that influences from corporate and governmental interests can contaminate the process. –Castleman & Ziem (1988); Legal challenges (2000-2001). 1980s - Present 1990s – Present 1990s - Present

15. 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. The “RCFC” Case -- Refractory Ceramic Fibers Coalition, et. al. vs. ACGIH. The “Trona” Case -- Anchor Glass Container Corp., et. al. vs. ACGIH, U.S. DOL, and U.S. DHHS.

16. Lessons TLVs ® provide vitally important benchmarks for occupational exposure assessment. The status of TLVs ® as guidelines,not standards, is not understood by many outside our profession. The “3 C’s” of the TLV ® development process. –Communication, –Confidentiality, –Conflict of Interest.

17. Role of the TLV ® in the Overall Context of Risk Management Research Risk Assessment Risk Management Development of regulatory options Evaluation of social, economic & political consequences Regulatory decisions and rulemaking Toxicity assessment Risk characterization Exposure assessment

18. Risk Characterization The process of organizing, evaluating, and communicating information about the nature, strength of evidence, and likelihood of adverse health effects from particular exposures. Final Report: The Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997

19. ACGIH ® Statement of Position ACGIH is not a standards setting body. TLVs ® and BEIs ® — Are an expression of scientific opinion. Are not consensus standards. Are based solely on health factors; it may not be economically or technically feasible to meet established TLVs ® or BEIs ®.

20. ACGIH ® Statement of Position TLVs ® and BEIs ® — Should NOT be adopted as standards without an analysis of other factors necessary to make appropriate risk management decisions. Can provide valuable input into the risk characterization process. The full written Documentation for the numerical TLV ® or BEI ® should be reviewed.