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Kei MORI, MD Deputy Director Environmental Risk Assessment Office

Kei MORI, MD Deputy Director Environmental Risk Assessment Office Ministry of the Environment, Japan. Japan Environment and Children's Study (JECS). I4C Workshop on September 19-20, 2011, Barcelona, Spain. Background Pilot Study Japan Environmental & Children’s Study (JECS).

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Kei MORI, MD Deputy Director Environmental Risk Assessment Office

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  1. Kei MORI, MD Deputy Director Environmental Risk Assessment Office Ministry of the Environment, Japan Japan Environment and Children's Study (JECS) I4C Workshop on September 19-20, 2011, Barcelona, Spain

  2. Background • Pilot Study • Japan Environmental & Children’s Study • (JECS)

  3. What's Happening to Today’s Children? Increase in Immune System Diseases, such as Childhood Asthma Increase in Congenital Anomalies, such as Hypospadias and Down’s Syndrome School Health Survey ICBDSR(2006) Birth defect cases have doubled over a 25-year period Childhood asthma has tripled over a 20-year period

  4. What's Happening to Today’s Children? Increase in Psycho-neurodevelopment disorders such as children receiving medical treatment for mental and behavioral disorders Patient Survey ●Impact on childhood development from exposure to low levels of methyl-mercury (Seychelles and Faeroe Islands [Denmark] among others) ●Mental deterioration / Decreased intelligence from exposure to low levels of lead(United States) ●Impact on childhood development from exposure to low levels of PCB (United States, Taiwan) ●Health impacts seen in children with exposure to organoarsenic compounds (decreased intelligence and autonomic nerve disorders in Japan) Examples of chemical exposure effects on humans

  5. Called for concerted actions in seven policy areas: Environmental risk assessments and standard setting; Children’s exposure to lead; Microbiologically safe drinking water; Air quality; Environmental tobacco smoke; Emerging threats to children’s health from endocrine disrupting chemicals; and Impacts of global climate change to children’s health. Miami Declarationat G8 Environment Ministers Meeting in 1997

  6. Session on children’s health and the environment was opened by Japanese Environment Minister Mr. Saito and US EPA Administrator Ms. Jackson. Ministers agreed to: Accelerate the phase-out of lead in paints and complete the global ban on lead in gasoline; Collaborate on research related to children’s health and the environment, including the impacts of chemicals, heavy metals and climate change Improve knowledge and build capacity on children’s environmental health. G8 Environment Ministers Meeting in Siracusa, Italy in 2009

  7. Background • Pilot Study • Japan Environmental & Children’s Study • (JECS)

  8. Pilot Study The following endpoints will be evaluated: 1. Feasibility of conducting the intended research 2. Limitations and problems observed in the pilot studies 3. Ways of obtaining high recruitment and implementation rates in the follow-up 4. Procedures which are less burdensome for health care professionals 5. Data quality control system for biological samples and questionnaires Two preceding cohorts (Hokkaido University and Tohoku University) -Establishment of analytical methods for biological samples.

  9. Pilot Study ・ Institution 1. Jichi Medical University 2. Kyushu University 3. University of Occupational and Environmental Health 4. Kumamoto University ・ Period Recruitment: August 2008–March 2010 Follow-up: August 20008–present ・ Study Methods Study methods were designed by each university; - comparison of methods is necessary to make a common and bias-free procedures of JECS

  10. Pilot Study ・ Recruitment 453 pregnant women among the four universities ・ Questionnaire common questionnaire was developed and used in each institution. ・ Sampling

  11. Pilot Study

  12. Pilot Study Findings ・　The consent rate of pregnant women was 69–98%. ・　When participants changed hospitals for delivery or had emergency deliveries, chance of collecting cordblood was reduced. To increase the sampling rate, development of better collection strategy is warranted for those cases. Results of Questionnaire ・　 As their motivations for participating in the study, approximately 50% of the participating women selected “contributions to society“ and approximately 30% selected “interest of the study" from the multiple choices. ・　The participating women were asked about what methods they would prefer when answering questionnaires. Approximately 60% answered they preferred “filling out paper-based forms.” Approximately 20% liked “a web based form or answering over a mobile phone.” ・　 Approximately 60% of husbands agreed to donate their blood in the study.

  13. Background • Pilot Study • Japan Environmental & Children’s Study • (JECS)

  14. Overview of the Japan Environment & Children’s Study (JECS) • Core Hypothesis: Chemical exposure during the fetal and infant stages adversely effects children’s health • Method: Birth cohort study • Scope: 100,000 participants nationwide • Term: recruitment 3 years, follow up 13 years • Funding: 3.1 billion yen ( $40 million) in FY 2010 • 4.6 billion yen ( $60 million) in FY 2011 • Anticipated Results • (1) Identify environmental factors impacting children's health • (2) Develop risk management systems that address vulnerabilities in children • (3) Ensure a sound environment where future generations are able to grow up in good health • (4) Establishment of infrastructures for children’s study

  15. Chemical exposure during the fetal and infant stages adversely effects children’s health JECS Core Hypothesis (Exposure) (Outcome) ○ The Environment / Chemicals POPs(dioxins, PCBs, organofluoric compounds, flame retardants, etc.), heavy metals (mercury, lead, arsenic, cadmium, etc.), endocrine disruptors (bisphenol A, etc.), agrichemicals, VOC (benzene, etc.), etc. ○ Physical Development: Low birth weight, development after birth, etc. ○ Congenital Anomalies: Hypospadias, Cryptochidism,cleft lops, cleft palate, Spina Bifida, digestive tract obstruction, ventricular septal defects,Down’s Syndrome, etc. ○ Sexual Differentiation Abnormalities: Sex ratio, genital development impairment, sexual differentiation of the brain, etc. ○ Psychoneuro DevelopmentDisorders: Autism, learning disorders, AHDH (attention-deficit hyperactivity disorder), etc. ○ Genetics ○ Immune System Disorders: Pediatric allergies, atrophy, asthma, etc. ○ Socioeconomics ○ Endocrine / Metabolic Abnormalities: Lowered glucose tolerance, obesity, etc. ○ Lifestyle

  16. Organization Cooperation National Center (National Institute for Environment Studies) Ministry of Health, Labor and Welfare ・ Act as implementation body ・ Data systems management, specimen storage, and accuracy control. ・ Support and oversight of Unit Centers. Ministry of Education, Culture, Sports, Science and Technology International Organization (WHO, etc), United States and other countries. ・Overall Planning ・Budgeting Medical Support Center (National Center for Child Health and Development) ・ Provide medical support ・ Support protocol writing relating to the outcome measurement. ・ Guidance and support for health care professionals involved in the study. Cooperation LocalGovernments ・PR/Outreach to increase citizens awareness and participation. ・ Assist recruitment through the Mother-Child Health Handbook. ・ Provide administrative data based on applicable laws. Regional Centers (15 locations nationwide) ・ Recruit study participants and conduct follow- up until 13 years old. ・Collect biological specimens and implement questionnaire program . ・Communicate with participants through individual consultation services. Cooperating Local Medical Institutions (Hospitals and Clinics) ・ Each regional center requests cooperation from local medical institutions (University hospitals, general hospitals and clinics) ・ Register study participants (expectant mothers) and collect biological specimens Ministry of the Environment

  17. Study Locations

  18. JECS Research Components Enrollment of 100,000 pregnant women ・Informed consent ・Questionnaire ・Collect mother’s blood and urine samples ・Collect environmental samples Early pregnancy Long-term Storage （Specimen Bank） Mid to late pregnancy Measure Chemical Substances ・Evaluate health condition of baby at birth ・Collect cord blood samples ・Collect parent’s blood samples ・Collect baby’s dried blood samples At birth Analyze Results 1 month old ・ Collect breast milk and mother’s hair ・Collect baby’s hair 6 months to 12 years old ・ Questionnaire（every 6 months) ・Interview（every several years） ・Collect environmental samples Statistical Analysis Identify environmental factors affecting children’s health

  19. Type of Data and material Collection T1* means 1～15 weeks of gestation. T2* means 16～27 weeks of gestation.

  20. We will use external mechanisms (such as cancer registration) to identify child cancer cases from JECS. Childhood cancer as an outcome

  21. JECS LAUNCH • MOEJ*has started Japan Environment and Children’s Study (JECS) in Jan 2011. * MOEJ : Ministry of the Environment government of Japan

  22. JECS website: • http://www.env.go.jp/en/chemi/hs/jecs/ • Contact: • E-mail: hoken-risuku@env.go.jp • Environmental Risk Assessment Office, • Ministry of the Environment, Japan

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