ACGIH

1
ACGIHs 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
• 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

• 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.

7
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)

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
30.4 CNS effects 12.0 Respiratory effects
8.8 Liver effects 8.7 Blood effects
6.4 Kidney effects 4.7 Skin effects
3.8 Cancer 3.7 Sensitization 2.8 All
other effects 18.7
12
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

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. Board Approval
Comm. Review Revision
NIC
Adopted Value
Comm. Board Approval
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)
• ACGIHs 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 Cs 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.