TRC’s Activities for Chemical Substance Control

1. TRC’s Activities for Chemical Substance Control TRC Fuel Research Conference June 14, 2010 Fukumi Nishimaki TonenGeneral Research Center

2. Outline • Background • TRC’s Activities for Chemical Substance Control • ETBE Risk Assessment • Chemical Substance Control Law • GHS-Compliant MSDS • Recommendation

3. Background • Increased public concern over chemical substances • Agreement at the World Summit on Sustainable Development (2002) • Minimize adverse effects of chemicals on human health and the environment • Local legislation has been updated accordingly • Chemical Substance Control Law (CSCL) • Industrial Safety and Health Law (ISHL) • Law for PRTR and Promotion of Chemical Management • Compliance of fuel products with chemical substance regulations is therefore becoming much more important • TRC is also delivering values on this area

4. ETBE Risk Assessment - Background • History • Oil industry decided to Introduce ETBE Blended Gasoline • The government’s Kyoto Protocol Target Achievement Plan (2005) • ETBE was categorized as CSCL Type-II monitoring chemical substance • Risk assessment before nationwide use was recommended by METI’s council • PEC performed the following programs with academia: • ETBE risk assessment (ex-carcinogenicity) with METI’s subsidy (FY2006-FY2007) • Supplementary study on ETBE carcinogenicity using PAJ fund (FY2006-FY2009) • TonenGeneral has made great contribution to the PEC programs • Only TRC (It’s Me!) has expertise in this field throughout the industry • Consultation through ExxonMobil’s global network

5. Inhalation exposure Atmosphere Tank Loading to TT Loading to UGT Fueling cars Evaporation Rfn (30) Cars (75 mil) SS (48,000) Trm (240) Leakages from UGT and piping Soil, Groundwater Oral intake No risk Exposure Level <RV Toxicity level (Severity of incident) Risk existed Exposure Level >RV Exposure level (Frequency of incident occurrence) ETBE Risk Assessment – Program Design ETBE Risk Assessment – Program Design(1) • ETBE risk assessment, sponsored by METI • Exposure study → Simulated Lifetime Exposure Level • Exposure assessment via oral intake and inhalation routes • Simulated ETBE level in air /drinkable underground water by ADMER model or HSSM model • Toxicological study →Animal tests →Reference Value • A series of long-term toxicity tests 180-day oral toxicity, 90-day inhalation toxicity, Kinetics Reproduction toxicity, Prenatal developmental toxicity • Determined Reference Value (RV) for human • Risk Assessment →Riskjudged by Margin of Exposure (MOE) between RV and Exposure Level (in accordance with OECD TG) MOE (Margin of Exposure) • A small amount of poison causes no health adverse effects. • Excessive food intake develops a disease.

6. ETBE Risk Assessment – Program Design(2) • ETBE carcinogenicity study, sponsored by PAJ • Genotoxicity tests ETBE is mutagenic or not ? • Screening and mechanism studies (mode of action)Applicable to human or not ? • Findings observed in animals is sometimes not applicable to human and animal specific events. • Mode of action is very important. • 2-year carcinogenicity tests in rats(Lifetime exposure tests) • Inhalation study • Drinking water study Picture from the 2-year inhalation test. Rats were exposed to ETBE in whole-body inhalation system.

7. ETBE Risk Assessment – Conclusions ETBE Risk Assessment – Conclusions (1) Health effects of ETBE on human is slightly and not be concerned. (2) Public health risk is not expected in case of inhalation of ETBE from air.Also, Public health risk is not expected in contaminated drinking water based on following risk scenario; that SS conducts ordinary inventory check for early detection of leaks and takes necessary measures to avoid diffusion of ETBE contaminated into soil or underground water. (3) ETBE is not carcinogenic to human in oral intake and also in inhalation exposed at environmental levels.

8. ETBE Risk Assessment – Global Contribution • Submitted Public Comment to US EPA’s “ETBE Toxicological Review Draft” • US EPA’s ETBE review is not credible scientifically, their conclusion is mistaken • US EPA did not refer PEC’s Report of ETBE Risk Assessment. • Translated the full reports of ETBE risk assessment and ETBE carcinogenicity study to English. Submitted the English versions to EPA. • Released both English and Japanese versions of Full Reports on JPEC Home Page (English Page) http://www.pecj.or.jp/english/index_e.html • Appropriate and timely information sharing with API, Lyondellbasel and ExxonMobil HQ (Fairfax) through global network. • Contributed to the important policy discussion scientifically not only in Japan but also USA/EU.

9. CSCL - Background • Fuels were regarded as existing chemical substances that were not regulated under the former CSCL • Components in fuels were also outside the scope of the former CSCL, as most of them are non-persistent substances • ETBE was the first substance reviewed under CSCL • ‘1-Methylnaphthalene’ Shock • Last year, oil companies struggled to report its production/shipping volumes of the component contained in LCGO/FOA, as it was registered as CSCL Type-III monitoring substance • A lot more coming at the revision of CSCL • Non-persistent hazardous substances are added in CSCL (2010) • Existing substances are also required to be reported under CSCL (2011)

10. CSCL – New Protocol from 2011 New Chemical Substances Existing Chemical Substances (Approx. 20,600) General Chemical Substances • Mandatory annual reporting of production and shipment volumes Risk Screening • Uniform approach of risk assessment using hazard / exposure matrix tool • Companies handling PACS are obliged to report toxicity of the substance Priority Assessment Chemical Substances (PACS) Risk Assessment • Limitation of production/import • Mandatory annual reporting of planned / actual production and shipment volumes Class-II Specified Chemical Substances (SCS) * Excluded potential persistent or bio-accumulative substances

11. CSCL – Industry Response • PAJ established WG to study the revision of CSCL (2009) • EM Members: AP Environment Advisor (Kobayashi-san / Inoue-san), AP Refining PQA (Tsunoda-san) and TRC (Nishimura) • WG addressed the following concerns: • Reporting of a number of Chemical Substances in Fuels • METI requested oil companies to report (from 2011) not only fuels but also a number of chemical substances contained, as did for 1-methylnaphthalene • No Consideration of Fuels in CSCL Risk Screening • Fuels would automatically be classified as PACS in the uniform risk screening regardless of their actual risk, due to their significantly-large volume scale • No Essential Use Allowance Defined for Class-II SCS • Significant impact on society would be expected, if fuel is rated as Class-II SCS

12. CSCL – TRC’s Contributions • Demonstrated leadership in PAJ WG • Successfully advocated for exemption of fuel products from CSCL • Fuels are regulated in Air Pollution Control Act via Fuel Quality Control Law • Exemption for blend streams is still under discussion with METI • Also advocated for no reporting of PACS in fuels from 2011 • METI now regards fuel products as UVCB (Unknown or Variable Composition complex reaction products and Biological materials) • Defined appropriate exposure levels of fuels for CSCL risk assessment • Established PAJ funded program for PEC to summarize hazard data of fuels • Support preparation of Year-2009 reporting due at the end of June • Working with S/H/E, Supply and associated departments

13. GHS-Compliant MSDS • Use of GHS-Compliant MSDS is mandatory from 2011 • TRC is responsible for localization of GHS-Compliant MSDS for • Domestic products (including test fuels) as technical support for FM • Using PAJ common MSDS template, considering product exchange activities • Semi-products (blend-stocks / feed-stocks) and export products for R&S • Working with EMBSI as local editor and business document approver in PSIMS • TRC ensures all the contents in MSDS meet associated chemical control laws (PRTR, ISHL, CSCL, etc.)

14. Recommendation • Coordinated activities over functions would be a key for successful chemical substance management • Maintain healthy network between functions (TG, TCC, EMYK-FM, EMYK-CD, EMYK-L&S and TRC) to share information: • External information, especially those from Japan Chemical Industry Association • Internal information such as global guidance in each function • Business line coordinator should be assigned to take care of overall chemical substance management, to avoid any missing between functions • Expertise of chemical substance control should be extended in ExxonMobil Japan • Cross-functional training/workshop for staff