Kei MORI, MD Deputy Director Environmental Risk Assessment Office

Japan Environment and Children’s Study 11

Kei MORI, MD 　　

Deputy Director Environmental Risk Assessment Office

Ministry of the Environment, Japan

Japan Environment and Children's Study (JECS)

Japan Environment and Children's Study (JECS)

I4C Workshopon September 19-20, 2011, Barcelona, Spain


Background

Pilot Study

　

Japan Environmental & Children’s Study

(JECS)


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Hydrocephaly

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Increase in Congenital Anomalies, such as Hypospadias and Down’s Syndrome

Increase in Congenital Anomalies, such as Hypospadias and Down’s Syndrome

Birth defect cases have doubled over a

25-year period

What's Happening to Today’s Children?

School Health Survey

Increase in Immune System Diseases, such as Childhood Asthma

Increase in Immune System Diseases, such as Childhood Asthma

Childhood asthma has tripled over a 20-year

period

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Elementary School

Junior High School

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Increase in Psycho-neurodevelopment disorderssuch as children receiving medical treatment for mental and behavioral disorders

Increase in Psycho-neurodevelopment disorderssuch as children receiving medical treatment for mental and behavioral disorders

●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

What's Happening to Today’s Children?


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 Declaration 　　at G8 Environment Ministers Meeting in 1997


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


Background

Pilot Study

　　


(JECS)


Pilot Study


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


Pilot Study

・ Recruitment 453 pregnant women among the four universities

・ Questionnaire common questionnaire was developed and used in each institution.

・ Sampling

Time Biological Sample1st and 3rd trimester Maternal blood and urine

At Birth Cord blood and umbilical cord

1 month after delivery Brest Milk


Pilot Study

　 Jichi Medical University

Kyushu University

University of Occupational

and Environmental

Health

Kumamoto University Total

Number of Participants 151 140 112 50 453

Consent Rate 69% (151/218) 98% (140/143) N/A 70% (50/71) 69–98%

Sampling Rate 　　　　

Maternal blood 100% (151/151) 99% (139/140) 95% (107/112) 100% (50/50) 99% (447/453)

Cord blood on going 91% (127/140) on going 　 96% (48/50) -

Breast milk on going 84% (118/140) on going 　 96% (48/50) -


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 cord blood 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.


Background

Pilot 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 　

Overview of the Japan Environment & Children’s Study (JECS)


○ Physical Development:

Low birth weight, development after birth, 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.

○ 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.

○ Sexual Differentiation Abnormalities:

Sex ratio, genital development impairment, sexual differentiation of the brain, etc.

○ Psychoneuro Development 　 Disorders:Autism, learning disorders, AHDH (attention-deficit hyperactivity disorder), etc.

○ Psychoneuro Development 　 Disorders:Autism, learning disorders, AHDH (attention-deficit hyperactivity disorder), etc.

○ Immune System Disorders:

　　 Pediatric allergies, atrophy, asthma, etc.

○ Immune System Disorders:

　　 Pediatric allergies, atrophy, asthma, etc.

○ 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.

○ 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.

○ Genetics○ Genetics

○ Socioeconomics○ Socioeconomics

○ Lifestyle○ Lifestyle

(Exposure) (Outcome)

○ Endocrine / Metabolic Abnormalities:

　　 Lowered glucose tolerance, obesity, etc.

○ Endocrine / Metabolic Abnormalities:

　　 Lowered glucose tolerance, obesity, etc.

Chemical exposure during the fetal and infant stages adversely effects children’s health

JECS Core Hypothesis


Local 　 Governments

Cooperating Local

Medical Institutions

(Hospitals and Clinics)

Medical Support Center

(National Center for Child Health

and Development)

Regional Centers

(15 locations nationwide)

・ PR/Outreach to increase citizens awareness and participation.

・ Assist recruitment through the Mother-Child Health Handbook.

・ Provide administrative data based on applicable laws.

・ Each regional center requests cooperation from local medical institutions (University hospitals, general hospitals and clinics)

・ Register study participants (expectant mothers) and collect biological specimens

・ Act as implementation body

・ Data systems management, specimen storage, and accuracy control.

・ Support and oversight of Unit Centers.

・ Overall Planning

・ Budgeting

Ministry of

the Environment

Ministry of Health, Labor and Welfare

National Center

(National Institute for Environment Studies)

Cooperation

Ministry of Education, Culture, Sports, Science and Technology

Cooperation ・ Provide medical support・ Support protocol writing relating to the outcome measurement.・ Guidance and support for health care professionals involved in the study.

Organization


Study Locations


・ Questionnaire （ every 6 months)・ Interview （ every several years ）・ Collect environmental samples

・ Collect breast milk and mother’s hair・ Collect baby’s hair

・ Evaluate health condition of baby at birth・ Collect cord blood samples・ Collect parent’s blood samples・ Collect baby’s dried blood samples

Early pregnancy

At birth

1 month old

6 months to 12 years old

　 Identify environmental factors affecting children’s health

Analyze Results

・ Informed consent・ Questionnaire・ Collect mother’s blood and urine samples・ Collect environmental samples

Measure Chemical Substances

Statistical Analysis

Long-term Storage （ Specimen Bank ）Mid to late pregnancy

Enrollment　of　100,000　pregnant　women　

JECS Research Components


T1* means 1 ～ 15 weeks of gestation. T2* means 16 ～ 27 weeks of gestation.

Type of Data and material Collection


　

General Study Detailed Study Additional Studies

Definition

Study to be implemented under the Ministry of the Environment’s budget with the goal of researching 100k participants

Study to be implemented under the Ministry of the Environment’s budget targeting a cross-section (Approx. 5k) of the 100k-participant cohort study

Studies to be implemented under the budget of each individual Regional Center with the approval of the Ministry of the Environment targeting a narrowly defined cross section of the participant pool

Target

All Regional Centers nationwide. All uniform items nationwide.Anticipate approx. 100k participants.

Approx, 5k participants selected from the 100k-participant nationwide general study. Participants to be selected from each Regional Center.

Sub-cohort or entire participant pool dependent upon Regional Center and proposed study. To be implemented under the approval of the Ministry of the Environment.

Items to be Studied

Items able to be studied uniformly nationwide

Conduct a further detailed study, in addition to the items from the general study

Able to establish a unique set of research items

Budget

Ministry of the Environment to allocate operating budget for the study

Ministry of the Environment to allocate operating budget for the study

Budget to be secured by each Regional Center using national government subsidies / grants or research money acquired from the private sector

Imple-mentation

・ Mother’s blood and urine sample ・ Father’s blood sample ・ Umbilical blood and breast milk sample・ Medical exam records・ Questionnaire・ Individual Chemical Exposure 　 Measurement・ Transcribe Mother-Child Health 　 Handbook・ Pediatric medical exam・ Child’s blood and urine sample

In addition to at left, the following:

・ Interview study (psychoneurological development)

Unique set of items to be determined by the type of study


Childhood cancer as an outcome

• We will use external mechanisms (such as cancer registration) to identify child cancer cases from JECS.


• MOEJ* has started Japan Environment and Children’s Study (JECS) in Jan 2011.

* MOEJ : Ministry of the Environment government of Japan

JECS LAUNCH


JECS website:http://www.env.go.jp/en/chemi/hs/jecs/

Contact:　　　 E-mail: [email protected]

Environmental Risk Assessment Office, Ministry of the Environment, Japan

Kei MORI, MD Deputy Director Environmental Risk Assessment Office

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