Proprietary VG-1

TRC’s Activities for Chemical Substance ControlTRC’s Activities for Chemical Substance Control

TRC Fuel Research ConferenceTRC Fuel Research Conference

June 14, 2010June 14, 2010

Fukumi NishimakiFukumi Nishimaki

TonenGeneral Research CenterTonenGeneral Research Center

Proprietary VG-2

OutlineOutline

• BackgroundBackground

• TRC’s Activities for Chemical Substance Control TRC’s Activities for Chemical Substance Control

– ETBE Risk AssessmentETBE Risk Assessment

– Chemical Substance Control LawChemical Substance Control Law

– GHS-Compliant MSDSGHS-Compliant MSDS

• RecommendationRecommendation

Proprietary VG-3

BackgroundBackground

• Increased public concern over chemical substances Increased public concern over chemical substances

– Agreement at the World Summit on Sustainable Development (2002)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 accordinglyLocal 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 Compliance of fuel products with chemical substance regulations is therefore becoming much more importanttherefore becoming much more important

• TRC is also delivering values on this areaTRC is also delivering values on this area

Proprietary VG-4

ETBE Risk Assessment - BackgroundETBE Risk Assessment - Background

• HistoryHistory

– Oil industry decided to Introduce ETBE Blended GasolineOil 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 substanceETBE 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: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 programsTonenGeneral has made great contribution to the PEC programs

– Only TRC (It’s Me!) has expertise in this field throughout the industryOnly TRC (It’s Me!) has expertise in this field throughout the industry

– Consultation through ExxonMobil’s global networkConsultation through ExxonMobil’s global network

Proprietary VG-5

ETBE Risk Assessment – Program DesignETBE Risk Assessment – Program DesignETBE Risk Assessment – Program Design(1)ETBE Risk Assessment – Program Design(1)

• ETBE risk assessment, sponsored by METIETBE risk assessment, sponsored by METI

– Exposure study → Simulated Exposure study → Simulated Lifetime Exposure LevelLifetime 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 →Toxicological study →Animal tests →Reference ValueReference 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 →Risk Assessment →RiskRisk judged by judged by Margin of Exposure (MOE) Margin of Exposure (MOE) between between RVRV and and Exposure Level Exposure Level

Exposure level(Frequency of incident occurrence)

Toxicity level(Severity of incident)

•A small amount of poison causes no health adverse effects.•Excessive food intake develops a disease.

Exposure Level < RV No risk

Exposure Level > RV Risk existed MOE

(Margin of Exposure)

(in accordance with OECD TG)(in accordance with OECD TG)

Rfn (30) SS (48,000)

Atmosphere

Cars (75 mil)Trm (240)

Inhalation exposure

Soil, Groundwater

Oral intake

TankLoading to TT Evaporation

Leakages from UGT and piping

Loading to UGT Fueling cars

Proprietary VG-6

ETBE Risk Assessment – Program Design(2)ETBE Risk Assessment – Program Design(2)

• ETBE carcinogenicity study, sponsored by PAJ ETBE carcinogenicity study, sponsored by PAJ

– Genotoxicity tests Genotoxicity tests ETBE is mutagenic or not ?ETBE is mutagenic or not ?

– Screening and mechanism studies Screening and mechanism studies (mode of action)(mode of action) Applicable to human or not ?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 rats2-year carcinogenicity tests in rats 　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　 (Lifetime exposure tests)(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.

Proprietary VG-7

ETBE Risk Assessment – ConclusionsETBE Risk Assessment – ConclusionsETBE Risk Assessment – ConclusionsETBE Risk Assessment – Conclusions

(1) Health effects of ETBE on human is slightly and not be concerned. (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 (2) Public health risk is not expected in case of inhalation of ETBE from air.from air. Also, Public health risk is not expected in contaminated Also, Public health risk is not expected in contaminated drinking water based on following risk scenario; drinking water based on following risk scenario;

that SS conducts ordinary inventory check for early detection of leaks and that SS conducts ordinary inventory check for early detection of leaks and takes necessary measures to avoid diffusion of ETBE contaminated into soil takes necessary measures to avoid diffusion of ETBE contaminated into soil or underground water. or underground water.

(3) ETBE is not carcinogenic to human in oral intake and also in (3) ETBE is not carcinogenic to human in oral intake and also in inhalation exposed at environmental levels. inhalation exposed at environmental levels.

Proprietary VG-8

ETBE Risk Assessment – Global ContributionETBE Risk Assessment – Global Contribution

• Submitted Public Comment to US EPA’s “ETBE Toxicological Review Draft”Submitted Public Comment to US EPA’s “ETBE Toxicological Review Draft”

– US EPA’s ETBE review is not credible scientifically, their conclusion is mistakenUS EPA’s ETBE review is not credible scientifically, their conclusion is mistaken

– US EPA did not refer PEC’s Report of ETBE Risk Assessment.US EPA did not refer PEC’s Report of ETBE Risk Assessment.

• Translated the full reports of ETBE risk assessment and ETBE carcinogenicitTranslated the full reports of ETBE risk assessment and ETBE carcinogenicity study to English. Submitted the English versions to EPA.y study to English. Submitted the English versions to EPA.

• Released both English and Japanese versions of Full Reports on JPEC Home Released both English and Japanese versions of Full Reports on JPEC Home Page (English Page) Page (English Page) http://www.pecj.or.jp/english/index_e.htmlhttp://www.pecj.or.jp/english/index_e.html

• Appropriate and timely information sharing with API, Lyondellbasel and ExxoAppropriate and timely information sharing with API, Lyondellbasel and ExxonMobil HQ (Fairfax) through global network.nMobil HQ (Fairfax) through global network.

• Contributed to the important policy discussion scientifically not only in Japan Contributed to the important policy discussion scientifically not only in Japan but also USA/EU.but also USA/EU.

Proprietary VG-9

CSCL - BackgroundCSCL - Background

• Fuels were regarded as existing chemical substances that were not Fuels were regarded as existing chemical substances that were not regulated under the former CSCLregulated under the former CSCL

– Components in fuels were also outside the scope of the former CSCL, Components in fuels were also outside the scope of the former CSCL, as most of them are non-persistent substancesas most of them are non-persistent substances

– ETBE was the first substance reviewed under CSCLETBE was the first substance reviewed under CSCL

• ‘‘1-Methylnaphthalene’ Shock1-Methylnaphthalene’ Shock

– Last year, oil companies struggled to report its production/shipping volumes of 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 the component contained in LCGO/FOA, as it was registered as CSCL Type-III monitoring substancemonitoring substance

• A lot more coming at the revision of CSCLA lot more coming at the revision of CSCL

– Non-persistent hazardous substances are added in CSCL (2010)Non-persistent hazardous substances are added in CSCL (2010)

– Existing substances are also required to be reported under CSCL (2011)Existing substances are also required to be reported under CSCL (2011)

Proprietary VG-10

CSCL – New Protocol from 2011CSCL – New Protocol from 2011

Existing Chemical Substances(Approx. 20,600)

General Chemical Substances

Priority Assessment ChemicalSubstances (PACS)

Class-II SpecifiedChemical Substances (SCS)

New Chemical Substances

Risk Screening

Risk Assessment

* Excluded potential persistent or bio-accumulative substances

• Mandatory annual reporting of production and shipment volumes

• Uniform approach of risk assessment using hazard / exposure matrix tool

• Companies handling PACS are obliged to report toxicity of the substance

• Limitation of production/import

Mandatory annual reporting of planned / actual production and shipment volumes

Proprietary VG-11

CSCL – Industry ResponseCSCL – Industry Response

• PAJ established WG to study the revision of CSCL (2009)PAJ established WG to study the revision of CSCL (2009)

– EM Members:EM Members: AP Environment Advisor (Kobayashi-san / Inoue-san),AP Environment Advisor (Kobayashi-san / Inoue-san),AP Refining PQA (Tsunoda-san) and TRC (Nishimura)AP Refining PQA (Tsunoda-san) and TRC (Nishimura)

• WG addressed the following concerns:WG addressed the following concerns:

– Reporting of a number of Chemical Substances in FuelsReporting 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 ScreeningNo 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 SCSNo Essential Use Allowance Defined for Class-II SCS

• Significant impact on society would be expected, if fuel is rated as Class-II SCS

Proprietary VG-12

CSCL – TRC’s ContributionsCSCL – TRC’s Contributions

• Demonstrated leadership in PAJ WGDemonstrated leadership in PAJ WG

– Successfully advocated for exemption of fuel products from CSCLSuccessfully 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 2011Also 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 assessmentDefined appropriate exposure levels of fuels for CSCL risk assessment

– Established PAJ funded program for PEC to summarize hazard data of fuelsEstablished PAJ funded program for PEC to summarize hazard data of fuels

• Support preparation of Year-2009 reporting due at the end of JuneSupport preparation of Year-2009 reporting due at the end of June

– Working with S/H/E, Supply and associated departmentsWorking with S/H/E, Supply and associated departments

Proprietary VG-13

GHS-Compliant MSDS GHS-Compliant MSDS

• Use of GHS-Compliant MSDS is Use of GHS-Compliant MSDS is mandatory from 2011mandatory from 2011

• TRC is responsible for localization TRC is responsible for localization of GHS-Compliant MSDS forof GHS-Compliant MSDS for

– Domestic products (including test fuels) Domestic products (including test fuels) as technical support for FM 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&SSemi-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 TRC ensures all the contents in MSDS meet associated chemical control laws (PRTR, ISHL, CSCL, etc.)control laws (PRTR, ISHL, CSCL, etc.)

Proprietary VG-14

RecommendationRecommendation

• Coordinated activities over functions would be a key for successful Coordinated activities over functions would be a key for successful chemical substance managementchemical substance management

– Maintain healthy network between functions (TG, TCC, EMYK-FM, EMYK-CD, Maintain healthy network between functions (TG, TCC, EMYK-FM, EMYK-CD, EMYK-L&S and TRC) to share information: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 Business line coordinator should be assigned to take care of overall chemical substance management, to avoid any missing between functions substance management, to avoid any missing between functions

• Expertise of chemical substance control should be extended Expertise of chemical substance control should be extended in ExxonMobil Japanin ExxonMobil Japan

– Cross-functional training/workshop for staff Cross-functional training/workshop for staff