TLV ® Chemical Substances Committee

1. TLV® Chemical Substances Committee The Process for Decision Making Presented at the AIHce June 3, 2002, San Diego, CA Bill Wells PhD, CIH, CSP, Moderator Dennis Casserly, PhD, CIH & Marilyn Hallock, CIH Monitors

2. Forum Overview • Scott Merkle: ACGIH® Structure • Lisa Brosseau: TLV®-CS Committee • Patrick Breysse: Conflict of Interest • Philip Bigelow: Notations & Designations • Dan Caldwell: Current Issues of Interest

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

4. 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.

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

6. 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

7. MembershipMarch 31, 2002 Private Industry & Others Government & Academia

8. Membership by Profession, 2001

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

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

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

12. 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

13. Committees May 2002 Merkle

14. Core Mission May 2002 Merkle

15. Topics of Debate Over the Years 1940s - Present 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. 1960s - Present 1980s - Present

16. Topics of Debate Over the Years 1990s – Present 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). 1990s - Present 1980s - Present

17. Legal Challengesof 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.

18. 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.

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

20. 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

21. 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®.

22. 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.

23. Chemical Substances TLV® Committee Lisa Brosseau, ScD, CIH Associate Professor University of Minnesota Chair, TLV®-CS Committee

24. 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

25. A Short Historical Perspective • 1941 TLV® Committee Created • Committee of Technical Standards creates Subcommittee on Threshold Limits (becomes independent committee in 1944) • 1946 List Published • First published list of “Maximum Allowable Concentrations” (MACs) for 150 chemical substances (renamed Threshold Limit Values in 1948)

26. History • 1955 Written Documentation • TLV® Committee begins to write Documentation for each TLV® (207 completed by 1958) • Published 1st edition in 1962 (257 substances)

27. History • Important Additions and Changes • 1961 - Skin Notation • 1962 - Carcinogens Appendix • 1963 - Excursion factors • 1964 - Notice of Intended Changes • 1968 - TLVs® for Physical Agents Committee • 1972 - Cancer classifications defined • 1980 - Operational guidelines & procedures • 1981 - List of Substances & Issues Under Study

28. History • More Changes • 1983 - Established Biological Exposure Indices (BEI®) Committee • 1993 - Deleted STELS for many substances • 1995 - CD-ROM • 1998 - Reformatted TLV® Book to include information on “TLV® Basis - Critical Effects”

29. Committee Structure • Chair • Recommendations from Committee & Staff; Board appoints • Vice-Chair, Subcommittee Chairs, Members • Recommended by Chair, appointed by Board • Three Subcommittees, each with Chair • Dusts & Inorganics (D&I) • Hydrogen, Oxygen & Carbon Compounds (HOC) • Miscellaneous Compounds (MISCO) • Staff Support (Liaison, Clerical, Literature Searching)

30. Chemical Substance Subcommittees • Approximately 10 members on each • Membership from academia, government, unions, industry • Membership represents four key disciplines: • Industrial Hygiene • Toxicology • Occupational Medicine • Occupational Epidemiology

31. Other Subcommittees • Chemical Selection • Recommendations to HOC, D&I, MISCO • Membership • Recruitment, screening, recommendations • Notations • Definitions, new proposals • Communications • Explaining our decisions

32. Committee Structure Board of Directors Staff Chair of TLV® Committee Administrative Subcommittees (Membership, Chemical Selection) Steering Committee Dust & Inorganics Subcommittee(D&I) Hydrogen, Oxygen, Carbon Subcommittee (HOC) Miscellaneous Compounds Subcommittee (MISCO)

33. TLV® Development Process Draft Doc. Under Study List Committee Review & Revision External Input Committee Review & Revision Committee & Board Approval NIC Committee & Board Approval Adopted Value

34. TLVs® Defined • TLV® — more than just “THE NUMBER” • Documentation describes: • Critical health effects • Quality of the data relied upon and areas of uncertainty • Possible sensitive subgroups • Type of TLV® (TWA, STEL, C) and reason for selection • Notations

35. Core TLV® Principles • Focus on airborne exposures in occupational settings • Utilize the “threshold” concept • Primary users are industrial hygienists • Goal is toward protection of “nearly all” workers Technical, economic, and analytic feasibility are NOT considered

36. The Essential Ingredients for Developing TLVs® Published / Peer Reviewed Science + Dedicated Volunteerism + Professional Integrity & Judgment

37. Warnings • NOT to be used as an index of relative toxicity • NOT for estimating toxic potential of continuous, uninterrupted exposures or other extended work periods • NOT as proof/disproof of existing disease • NOT to evaluate or control air pollution • NOT legal standards

38. Prefer human over animal data Use uncertainty factors, if necessary (but no “rules”) Look for threshold of effects Consider irritation an important health endpoint Not concerned with levels of risk Look for the “worst case” health endpoint Always select an exposure level Explain the reasons for our recommendations Summary

39. Policies and Processes forLimiting Conflict of Interest Patrick N. Breysse, PhD, CIH Johns Hopkins University Bloomberg School of Public Health Vice-Chair, ACGIH®

40. Background • Historical Perspective • assumed membership limited to government and academics controlled conflicts of interest • industry involvement as consultants, and as providers of data both formally and informally. • Industry representatives could be non-voting members of ACGIH® as of 1992 • Voting rights granted in 2000

41. Background (cont.) • The OSHA proposal to re-adopt the TLVs® as PELs resulted in increased scrutiny of the TLV® process and the role of “guidelines” • In the late 1980s and early 1990s ACGIH® was criticized as being “industry influenced” and for not limiting conflicts of interest

42. Background (cont.) • As a result of these events and other factors the ACGIH® began, in the mid-1990s, to: • Review of the TLV® process • Reevaluate of the role of industry membership • Reevaluate conflict of interest policies and procedures

43. Membership • Regular member • professional whose primary employment is with a government agency or an educational institution • Associate member • Student member • Retired member • Organizational member

44. Associate Member • Not eligible for Regular membership • Eligible to serve as voting members of appointive committees • May hold elective office as a Director-at-Large on the Board of Directors, and may vote on committee matters and ACGIH® elections. • May not vote on amendments to the Bylaws, serve as an officer on the Board of Directors, or as Chair of an appointive Committee or as a member of the Nominating Committee.

45. Conflict of Interest Policy and Procedures Development • Reviewed COI policies of numerous groups • Use the National Academy of Sciences model as the starting point • Held extensive discussions with TLV® committee and Board of Directors • Adopted COI Policy on September 17, 2000

46. BIAS (NAS definition) “Views stated or positions taken that are largely intellectually motivated or arise from close identification or association of an individual with a particular point of view or the positions or perspectives of a particular group.”

47. BIAS • NAS position • Must create a committee with a balance of potentially biasing backgrounds or professional or organizational perspectives • TLV® Committee approach • Attempt to create a balance of opinions and views by maintaining a diversity of professional affiliations, disciplines and activities among its membership

48. Conflict of Interest (NAS definition) “Any financial or other interest which conflicts with the service of an individual because it: (1) could impair the individual’s objectivity, or (2) could create an unfair competitive advantage for any person or organization.”

49. Conflict of Interest • Basis for Conflicts of Interest: • Employment • Financial benefit • Personal • Professional • Avoid perceived as well as real conflict of interest

50. Conflict of Interest • Committee members serve as individuals • they do not represent organizations and/or interest groups • Members are selected based on expertise, soundness of judgement, and ability to contribute