Improving Chemicals Management This work has been supported by the Switzer Foundation, the UC Toxic Substances Program, the CA Dept of Health Services HESIS program, and NIOSH.  

Overview U.S. EPA burden: high evidentiary requirements in gathering toxicity data Inadequate State-level chemical demographic data. Together, these have resulted in substantial gaps in demographic, toxicity and exposure data inability to prioritize chemical hazards & risks Needed: To improve State authority to regulate as a condition of market entry.

State of knowledge Priorities Laws & policies Agencies Health

(New chemicals) TSCA, EPA (Waste) RCRA, CERCLA/SARA Most statutes are “end-of-pipe”, information strategies or permissible exposure approaches (Air emissions) Clean Air Act NAAQS (New chemicals) TSCA, EPA Product, FDA Worker exposures, OSHA (Water discharges) Clean Water Act, TRI POTW ECY (Waste) RCRA, CERCLA/SARA

State of Knowledge Substantial procedural and evidentiary burden on EPA to acquire toxicity data from industry to restrict use “Existing” chemicals in 1979 “grandfathered”; no data required ( = 99% of chemicals in commerce 2007). EPA reliance on voluntary initiatives Up to 60% of 2,800 chemicals are now tested. 70,000 others remain mostly unknown. No action taken by EPA on tested chemicals. EPA asks for additional infromation on 10% of new chemicals; 90% are approved by default at 90 day window. of the 10%, 1/3 are withdrawn by industry, 1/3 EPA negotiates with industry for more information; 1/3 EPA and industry reach some agreement on the nature of controls.

State of Knowledge - Inadequate State-level data on industrial chemicals in commerce: Identification Quantities Distribution Use Toxicity Exposure

We are therefore unable to systematically evaluate What we found was that when you walk into a vehicle repair shop, this is what you see. Organic solvents were used extensively in all the shops we visited. We are therefore unable to systematically evaluate and prioritize chemical hazards.

Data gap consequences: Legislature: Inability to allocate resources to priority chemical concerns Government Agencies: Inability to systematically track disease and exposure trends Research Institutions: Inability to characterize background exposure, risk and disease outcomes Business and industry: Increased conflicting regulations = unanticipated costs Public, labor and NGOs: Inability to ID; advocate changes related to U POP chemicals.

Strategy options, given data uncertainty Act on best judgment Provide information Do nothing Clean-up the results Set safe levels Data gaps Voluntary approaches Study the problem Crisis-by-crisis

Strategy options, given inadequate data Act on best judgment Provide information Do nothing Clean-up the results Set safe levels Data gaps Voluntary approaches Study the problem Crisis-by-crisis

Laws & policies: Perchloroethylene, hexane and neurological disease in vehicle repair industry This story has to do with vehicle repair technicians who developed peripheral neuropathy as a result of their occupational exposure to n-hexane solvent. I’ll explain those terms in a minute, but like so many things, this study has been like a keyhole into an entire roomful of issues pertaining to the effectiveness of our public and environmental health regulatory system in California. This is an incredible story, in that we have found acute, debilitating neurological disease right here in the Bay Area, in an industry where it has never been seen before, and where the severity of symptoms among the affected workers are similar to what one reads about among solvent-disabled workers in basic industries in China, for example. The disease, peripheral neuropathy, is characterized by a gradual and eventually complete loss of sensation and motor control in the limbs. In this case, the hexane exposures that led to the cases of disease in fact occurred as a result of the solvent industry’s chosen response to environmental regulations promulgated by Cal EPA. This is what I want to talk about today. Before I do that, I will present three typical disease cases and talk a little bit about the exposure assessment, which is important in understanding the policy aspects of this issue. Let’s first look at some background on n-hexane. ****************** This case study is similar to one reported in S. Korea, where 2-bromopropane, a potent reproductive hazard, was recently introduced by the semiconductor industry as a substitute for CFCs, and Belgium where HCFCs, which are highly hepatotoxic, were also introduced as substitutes for CFCs. AIHA story. The point here is not to disparage the regulatory community (or the fire department) – We know that any action that attempts to move our society forward has an element of the unknown and therefore a risk of engendering unintended consequences – The point here is to help point out how regulation can be made more effective by anticipating the consequences and minimizing their effects. In this case, the unintended consequence surfaced in the form of a neurotoxin that was introduced as a substitute for a IARC 2A carcinogen. Harrison et al. MMWR, Nov 16 2001, Vol 50 #5, mmwr.gov

What is hexane? A petroleum distillate for cutting grease, oil 20-80% is n-hexane n-Hexane identified as peripheral neurotoxin Co-exposure with acetone amplify effects

Cases #1, #2 #3: 25, 45 and 52 y/o vehicle repair technicians Presentation Numbness from hips to feet, mid-forearm to fingers, loss of grip strength Ataxia Exposure Daily occupational exposure to cleaning solvents containing 10 to 90% hexane, blended with acetone. I would like to briefly describe the index case profiles.

Follow-up cases 11 additional technicians fit case definition for hexane-induced peripheral neuropathy. Some disabled, unemployed; some employed with early signs of disease. Finally, the Occupational Health Branch of CDHS followed up with 18 possible cases that were identified through the International Association of Machinists. 11 of these met the criteria for hexane-induced peripheral neuropathy. This suggested that in all liklihood, other cases existed throughout the state. (Use of photographs approved by Committee for the Protection of Human Subjects, UC Berkeley, file #2000-9-43)