Update on Cal/OSHA PELs and Process CIHC 16 th Annual Conference 2006 San Diego, California

1. Update on Cal/OSHA PELs and ProcessCIHC 16th Annual Conference 2006San Diego, California • History & Background • Recent Cal/OSHA PEL amendments • Outlook and process going forward

2. Cal/OSHA Program Structure Within the Department of Industrial Relations (DIR): • Cal/OSHA Standards Board • Cal/OSHA Appeals Board • Cal/OSHA Consultation Service (within DOSH) • Division of Occupational Safety & Health (DOSH)

3. DOSH Health Standards Role Labor Code 147.1 Health Standards Functions of the Division of Occupational Safety and Health • Analyze new Federal OSHA standards • Maintain liaison with OSHA and NIOSH • Evaluate the need for new standards • Evaluate health-related variances

4. Labor Code 144.6 • Labor Code 144.6. Criteria considered in adoption of standards concerning toxic materials or harmful physical agents …..the board shall adopt that standard which most adequately assures, to the extent feasible, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to a hazard regulated by such standard for the period of his working life.. ….In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the reasonableness of the standards, and experience gained under this and other health and safety laws.

5. Cal/OSHA Permissible Exposure Limits (8 CCR 5155) • Standards Board (with staff work by DOSH) has periodically updated PELs in section 5155 in groups of substances since the early 1980s • Nationally recognized standards such as ACGIH TLVs and NIOSH RELs have generally been used as the starting point for consideration, but they are independently evaluated and not automatically adopted as PELs • Have used an expert advisory committee to assist with development of recommendations for proposal to the Cal/OSHA Standards Board

6. PELs – Federal OSHA • 1970 OSHA adopts 1968 TLVs into 29 CFR 1910.1000 • 1989 OSHA publishes revisions for approximately 376 substances, mostly adopting TLVs • 1992 1989 rulemaking overturned by 11th Circuit Court in response to legal action of both employers and organized labor • OSHA comprehensive standards with PELs since 1989: • Cadmium 1992 • Methylene dianiline 1992 • Formaldehyde (1992) • Lead in construction 1993 • Asbestos 1994 • 1,3-Butadiene 1996 • Methylene chloride 1998 • Hexavalent chromium 2006 )

7. PELs – Cal/OSHA • Since 1995 the Cal/OSHA PEL Advisory Committee has incorporated tools of health risk assessment to develop PEL recommendations. • Increased sophistication of the PEL development process is consistent with greater quantities and availability of information, especially through the Internet. • One result has been greater frequency of recommendations by the PEL Advisory Committee for PELs below the TLV

8. DOSH PEL Advisory Committee PEL Advisory Committee: • Expert volunteers • Meetings four to six times per year coordinated by DOSH • Members expected to serve as independent experts, not stakeholders • Disciplines: toxicology, epidemiology, industrial hygiene, occupational medicine, health risk assessment Paper published by last PEL Advisory Committee describes the technical review process used most recently: Intl Journal of Occupational and Environmental Health Vol 12 (3) July-Sept 2006 pg 242 Link at: http://www.ijoeh.com/

9. DOSH PEL Advisory Committee For non-carcinogens since the mid-1990s the PEL Committee has generally taken a NOAEL* approach where supported by data, or a LOAEL* approach if data is more limited, applying safety factors commensurate with the nature of the risk, eg. irritant vs. sensitizer. General formula used to translate toxicology study findings: (Daily dose from study) X (body weight or surface area correction) (Susceptibility factor) X (Species factor) X (Severity factor) X (Daily air volume) For carcinogens, the Committee began in the late 1990s to rely on published authoritative cancer risk assessments from EPA, NTP, etc. * NOAEL: No Observed Adverse Effect Level ** LOEAL: Lowest Observed Adverse Effect Level

10. The 4-Step Risk Assessment Process • Hazard Identification • Exposure Assessment • Dose-Response Assessment • Risk Characterization

11. Recent Developments • December 2003, proposal of PELs for a number of substances below the TLV (including glutaraldehyde) drew the attention of the Standards Board and interested parties. • 12 PELs at TLV in this group adopted and took effect November 3, 2004 • For the below-TLV recommendations, DOSH responded by holding 3 special advisory meetings on glutaraldehyde and another advisory meeting to take additional comments on other substances with PELs proposed below the TLV.

12. Recent Developments • September 2005, Standards Board public hearing held on 7 additional substances proposed at the TLV, and 10 substances from 2003 originally proposed below the TLV, with 7 revised upward to be at the TLV. • These PELs took effect July 6, 2006 and included beryllium (now 0.2 ug/M3) and glutaraldehyde (with a 2-year phase-in for the TLV Ceiling limit and a special footnote on its sensitizing effects). • Last round of work by the PEL Advisory Committe started in 2000. So TLV revisions since then have not been reviewed for inclusion in the PELs

13. Recent Cal/OSHA PEL amendments Effective November 3, 2004 acrolein, allyl alcohol, butyl acrylate, diethyl ketone, di-sec-octyl phthalate, ethyl buty ketone, *ethyl cyanoacrylate, *ethyl tert-butyl ether, *flour dust, maleic anhydride, molybdenum (insoluble compounds), pentane, *pentyl acetate Effective July 6, 2006 acetone, beryllium & compounds,*bis (dimethylaminoethyl) ether, 2-butoxyethanol, coal tar pitch volatiles (change to footnote only), crotonaldehyde, epichlorohydrin, glutaraldehyde (also added footnote), hexachlorobenzene, n-hexane, *1-hexene, methyl bromide, methyl 2-cyanoacrylate, methyl methacrylate, molybdenum (soluble compounds), propylene oxide, *1,3,5-triglycidyl-s-triazinetrione, *vinylidene fluoride * Substance new to the PEL list

14. PEL Development Process Discussion • Public advisory meetings held 12/12/05 and 6/9/06 to discuss the PEL development process going forward - discussed concerns about transparency and ease of access of interested parties to the process. Another meeting is planned for December 13, 2006 in Oakland • The process in the future should incorporate earlier and more detailed notice to interested parties as well as provision for separate treatment for particularly controversial substances. See PEL link for meeting minutes & draft process proposal at Health Advisory Committee: website www.dir.ca.gov/dosh/DoshReg/advisory_committee.html

15. PEL Development Process Discussion • GOALS OF THE PROCESS • Worker protection • Transparency • Stakeholder Participation • NEW PROCEDURAL OUTLINE (DRAFT) • Initial meeting for prioritization of substances • Technical Expert Advisory Committee (TEAC) to development health based recommendation • Follow-on public meetings to take comments on technical feasibility and cost impacts • Substance-specific advisory meetings if needed for specific substances of widespread interest or controversy

16. Resources for Keeping Up With Cal/OSHA Health Standards Activity • DOSH Health Advisory Committees website www.dir.ca.gov/dosh/DoshReg/advisory_committee.html • Standards Board website • Safety Advisory Committee announcements • Monthly meeting notices (45 days ahead) • Monthly meeting agendas (10 days ahead) • Approved regulations with archives • Office of Administrative Law website for official versions of regulations in effect www.oal.ca.gov