The impact of the OSHA adoption of the Globally Harmonized System Hey, What Happened to the Right-to- Know? Deborah Gold, MPH, CIH APHA 2015

Presenter Disclosures The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: Deborah Gold “No relationships to disclose”

Before OSHA Workers were not told contents of chemical mixtures, such as solvents, and chemicals were often labelled only with trade names Company information and industry- funded research kept confidential Hazards sometimes detected through kitchen-table epidemiology

The Fight for Right-to-Know Workers and unions demanded information about chemical hazards 1977 OSHA published preliminary hazard communications standard; dropped by Reagan Many states, including California, adopted RTK laws federal OSHA hazcom, preempted state/local regs except state plans

Key Elements of RTK Container labelling Data Sheet Disclosure of chemicals Safety information Disclosure of health effects, controls etc. Chemical inventory Training, written program Access to records Exposure (chemical, physical, biological agents) Medical records

Hazcom (I) Data sheet to disclose all chemicals With one positive study On certain source lists Listed as carcinogen by NTP or IARC Trade secrets can include ID, concentration Mixtures – ingredients > 1%, carcinogens > 0.1% (or less if would cause health effect) Data sheet to disclose health effects with one positive study, even if chemical ID withheld as trade secret

Hazcom (II) Written hazard determination procedures Label to include manufacturer contact info, chemical identity, “appropriate hazard warnings” Specific labelling under comprehensive standards Health effects defined in Appendix A, B Broad categories Some specified test methods and thresholds

Problems with Hazcom (I) MSDS did not list all hazardous ingredients No uniform format for MSDS info MSDS often buried health effects MSDS, labels not accessible by language, literacy Broad “trade secret” resulted in lack of disclosure Little enforcement on trade secret claims

Problems with Hazcom (II) Labels, MSDS differed for same chemical Labels, MSDS not updated Inadequate MSDS from companies that repackaged or reformulated Recyclers didn’t determine composition Many countries have no hazard communication requirements Little enforcement on labels, MSDS in US

Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Initiated in UN in 1992 recommended by ILO and OECD Adopted by UNCETDG/GHS Economic and Social Council of the United Nations recommended adoption, 1 st revision published 2009 – Third revision published OSHA rulemaking on HCS

Who Negotiated GHS? ILO is formally tripartite Most government delegations dominated by industry OECD dominated by industry and developed hazard classification GHS development under Clinton and Bush OSHA proposal developed under Bush, noticed in first years of Obama administration

GHS: “The Right to Understand” (David Michaels) Create global consistency Make hazard information available in all countries Pictograms and signal words to simplify messages Defined format for SDS – to avoid burying the message Required content for label warning messages Definition of safety hazards GHS pictogram for most chronic health hazards

What Did OSHA Do? Manufacturers now to use “weight of evidence” (WOE) to determine whether and how to classify a chemical Not required to disclose a chemical if determine WOE doesn’t require classification Abolished the “one study” requirement Abolished the “source lists” and mandatory carcinogen classification for NTP, IARC Still required to “check the box” if NTP or IARC Non-mandatory cross-walk in App F OSHA won’t enforce certain SDS sections

What Did OSHA Do? Written hazard determination procedures not required, MFR not required to “test” to determine hazard classification Weakened rules on mixtures for category 3 target organ effects – 20% cut-off Applies only to respiratory tract irritation and narcotic effects. Appendix A does not include GHS options for less serious effects in categories E.g. Eye damage only includes permanent and severe irritation (resolves within 21 days)

The “One Positive Study Rule” "Health hazard" means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. (HCS 1994)

Source Lists (HCS 1994) “…shall treat the following sources as establishing that the chemicals listed in them are hazardous:” (i) OSHA PELs (ii) ACGIH Threshold Limit Values (ACGIH) “…shall treat the following sources as establishing that a chemical is a carcinogen or potential carcinogen for hazard communication purposes:” NTP IARC OSHA Subpart z

Enforcement Under the One Positive Study Rule and Source Lists A chemical is not listed on the MSDS + present in product (at required concentration) + there is one positive study = evidence of violation A chemical is not listed on the MSDS + present in product (at required concentration) + it is on a source list = evidence of violation

OSHA’s GHS Weight of Evidence Appendix A: “…The quality and consistency of the data shall be considered. Information on chemicals related to the material being classified shall be considered as appropriate, as well as site of action and mechanism or mode of action study results. Both positive and negative results shall be considered together in a single weight-of- evidence determination.” (GHS 2012)

OSHA’s GHS Weight of Evidence Appendix A: “Positive effects which are consistent with the criteria for classification, whether seen in humans or animals, shall normally justify classification. Where evidence is available from both humans and animals and there is a conflict between the findings, the quality and reliability of the evidence from both sources shall be evaluated in order to resolve the question of classification… Therefore, positive results from well-conducted animal studies are not necessarily negated by the lack of positive human experience but require an assessment of the robustness, quality and statistical power of both the human and animal data.”

More often than not, highly qualified and experienced toxicologists and other experts disagree with regard to their interpretations of the same toxicological studies and other toxicological issues such as mode of action and physiologically based pharmacokinetics data. Their interpretations largely depend on whether they are affiliated with industry groups or government agencies and other public health organizations, and on the goals and purpose of their affiliated organizations. – Julia Quint, Comments submitted on Behalf of SF Physicians for Social Responsibility 5/10/13

“[One positive study] Is essential for protecting workers from occupational illnesses and diseases due to the limited amount of available toxicological information on most chemicals. Most chemicals are not tested before marketing and, except for the NTP cancer bioassays, are not routinely tested by government agencies. The toxicological database for most chemicals is very limited and consists for the most part of studies published by researchers associated with academic and other non-­‐ government organizations. A scientifically robust positive study, which provides evidence of an adverse health effect of a chemical is difficult to achieve and is not likely to be repeated…” – Julia Quint, PhD, Comments submitted on behalf of SF Physicians for Social Responsibility 5/10/13

We see this growing trend that disingenuously demands proof over precaution in the realm of public health…Animal data are deemed not relevant, human data not representative and exposure data not reliable. David Michaels, Doubt is their Product

Enforcement Under OSHA GHS Chemical not listed on SDS + present in product (at required concentration) + attempt to obtain manufacturer’s WOE determination (manufacturer not required to have hazard determination procedures under OSHA GHS) + competent toxicological/epidemiological testimony to establish WOE = contested evidence of violation (likely followed by appeal hearing “battle” of experts) How many toxicologists work for OSHA?

What should the threshold be for disclosure? A higher level of proof for a more severe consequence Criminal vs. civil cases Potential levels of chemical regulation Disclosure, warning Regulate exposure, use Ban Need to know chemical ID in order to enforce PELs, monitor, investigate illness

California’s State Plan California’s hazcom goes back to 1980 Men formulating pesticide DBCP became sterile A study had found testicular atrophy in animals more than 10 years prior Company official just didn’t believe it would cause harm to humans so didn’t disclose

Cal/OSHA Required to Adopt GHS Generally state plans only have to be “as effective as” OSHA Companies sued over incorporation of “Prop 65” into hazcom using the “products clause” (interstate commerce preemption) Resolved by courts when OSHA set conditions for incorporation into state plan

Cal/OSHA Required to Adopt GHS (II) Cal/OSHA required to get OSHA approval for differences California can not regulate products made in other states California law requires that containers be labelled in accordance with federal Hazcom standard and applicable California standards

What We Did Source lists are presumptive for classification; if MFR doesn’t classify, must document basis and state chemical and list on SDS One positive study requires listing chemical and health effect on SDS, if MFR determines not to classify Retained requirement for written hazard determination procedures Retained requirement for mixtures of 1 percent if that is below cut-off concentration

What the Chemical Companies Won Self-serving WOE determinations can allow companies not to: List a chemical on the SDS Classify a chemical hazard, therefore no warning on label or SDS Cut-offs and elimination of lower hazard classes result in less products classified and labelled, e.g. eye irritation Are toxic torts really a disincentive to chemical manufacturers at this time?

What’s Next for US GHS EPA controls labelling for pesticides, e.g. disinfectants and many detergents EPA label manual requires labelling of less severe health effects, e.g. Category 3 eye irritation “The Office of Pesticide Programs is not currently in the process of incorporating GHS into the FIFRA pesticide classification and labeling regulations, and does not plan to do so at this time.” (Lily Negash communication 10/21/15) GHS numbering not consistent with NFPA/HMIS OSHA has issued CPL; can they amend reg?

Thanks to everyone who helped Cal/OSHA out Comments to Cal/OSHA on GHS html Federal Hazcom page: