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PFAS Policy in Japan
12th February, 2024
Itsuki (Suki) Kuroda
Environmental Health Department, Ministry of the Environment, Japan (MOEJ)
1. Management of PFAS in Japan
1
PFOS, PFOA and PFHxS
2
PFOS (perfluorooctane sulfonic acid) PFOA (perfluorooctanoic acid)
Use
Firefighting foam, Metal plating treatment agents,
Anti-reflection agent used in the manufacture of semiconductors, etc.
Properties Persistent, Bioaccumulative, Chronic toxicity to human, flora and fauna
Regulations
in Japan
• Prohibition of manufacturing and import, etc. in principle as Class I
Specified Chemical Substances under the Chemical Substances Control
Law (CSCL) (PFOS designated in 2010, PFOA designated in 2021, PFHxS
designated in 2024)
• Setting provisional guideline values for water quality (50 ng/L as total of
PFOS and PFOA set out in 2020)
PFhxS (perfluorohexane sulfonic acid)
PFhxS
 Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (CSCL: Chemical Substance Controls Law)
 Enacted in 1973, last revised in June 2017
 Purposes: (1) Establish a system to evaluate the properties of new
chemical substances before their manufacture/import and (2) regulate
their manufacture, import, and use, depending on their properties, to
prevent environmental pollution caused by the chemical substances that
can harm human health or damage living environment of animals and
plants.
Chemical Substances Control Law (CSCL)
Regulates long-term toxicity to humans and impact on ecosystems through
environmental exposure
 Key measures
• Reviewing new chemical substances before their launch (500 to 700
cases/year)
• Performing environmental risk assessment on chemical substances that
are already on the market (approx. 28,000 substances)
• Regulates manufacture, import, and use of chemical substances
depending on their properties
3
 Substances that are persistent, highly accumulated, with long-term toxicity to humans or
predators of higher trophic and specified as Class I Specified Chemical Substances by the
government ordinance. 35 Substances including PCB and DDT.
Preventing from discharge of persistent,
high-accumulating, long-term toxic substances
What is “Class I Specified Chemical Substances”?
 Approval system for manufacturing/importing Class I Specified Chemical Substances
 Use of Class I Specified Chemical Substances for purposes other than for test/study and
essential use is prohibited.
 Import of products that use the Class I Specified Chemical Substances is prohibited.
 Order to collect substances and penal rules targeting the manufacturers, importers, and
users who violate the laws and regulations
Regulations of Class I Specified Chemical Substances
Class I Specified Chemical Substances
* Number of substances: as of Feb 2024
4
PFHxS Regulations under the CSCL in response to the Stockholm Convention
5
• June 2022 : Decision SC-10/3
• August 2023 : Central Environment Council
➢ Recommendation for designation of PFHxS and its salts as Class I Specified Chemical Substances (Prohibition of
manufacturing and import, etc. in principle)
➢ Recommendation to take measures on products containing PFHxS and its salts
• Summer 2023 : Public consultation on the draft Cabinet Order on
regulations on PFHxS and its salts based on the Recommendations
• September 2023 :TBT notification, and public comments on the proposed
amendments to the Decree
• Mid-November 2023 : Cabinet meeting
• February 2024 : Designation as a Class I Specified Chemical Substance
• Mid-May 2024 : Designation, etc. of import-prohibited products in which
Class I Specified Chemical substances are used.
Environmental Quality Standards
(Public water: 27 substance,
Groundwater: 28 substances)
Monitored Substances
(Public waters: 27 substances,
Groundwater: 25 substances)
Surveyed Substances
(136 substances)
Continuous monitoring,
Regulation of the discharging
of effluent
Significantly detected
in the environment
Monitored by prefectures, etc.,
Guidance based on
guideline values
Substances for which EQS are not set
immediately based on detection status
Environmental risk information of
substances that need to be collected
Information collection,
Monitoring by the government
Environmental Quality Standards for Water Pollution
PFOS, PFOA
Provisional guideline value:
50 ng/L
*Provisional guideline values for
drinking water quality management:
50ng/L (set out in FY2020)
PFHxS
PFOS, PFOA
(designated in FY2013)
(changed from surveyed
substance in FY2020)
6
TDI
[ng/kg/day]
Body Weight
[kg]
Daily Intake
[L/day]
Contribution Rate
of Drinking Water
[Percentage]
× × =
Provisional
Guideline Value
[ng/L]
20 ng/kg/day
50 kg
2 L/day
10 % 50 ng/L
Using the same approach as when the Ministry of Health, Labour and Welfare (MHLW) set the provisional
guideline values for drinking water, the following values were applied as the lowest values on the safe side
based on the results of toxicity assessments conducted by various countries and organizations as of 2020.
• 20 ng/kg/day for PFOS (Aus, NZ, and US): loss of body weight in young animals
• 20 ng/kg/day for PFOA (US): developmental abnormalities in young animals
Provisional Guideline Values for PFOS and PFOA in Water Environment
Toxicity Assessment
- 50 ng/L each for PFOS and PFOA
- Provisional guideline value for
total of PFOS and PFOA: 50 ng/L
(as a safe side value)
7
Monitoring Results of PFOS and PFOA in Japan
• Total 1,477 water quality monitoring
points from FY2019 – FY2021
(171 points in FY2019, 173 points in FY2020, and
1,133 points in FY2021)
• Total 139 points exceeded the
provisional guideline value, mainly
in urban and suburban areas.
*FY1999: Nationwide monitoring by MOEJ
FY2020: Nationwide monitoring by MOEJ
and local monitoring by municipalities
FY2021: Local monitoring by municipalities
8
PFOS and PFOA (Surface water)
PFOS and PFOA (Groundwater)
> 1000 ng/L
500 ng/L – 1000 ng/L
50 ng/L – 500 ng/L
50 ng/L <
> 1000 ng/L
50 ng/L – 500 ng/L
50 ng/L <
【 Environmental Survey and Monitoring of Chemicals】(FY2009 – FY2021) conducted by MOEJ
⚫ PFOS and PFOA in surface water, sediment and air: Evaluated to “An inter-annual
trend of decrease was found”
⚫ PFOS and PFOA in wildlife: Evaluated to “Although the number of detections was
small, the detection rate was decreased, it suggested a reduction tendency.”
Trend of Monitoring Results of PFOS and PFOA in Japan
9
Substance Surface water Wildlife Air
River area Lake area Mouth area Sea area Bibalves Fish Warm season
PFOS - - - -
PFOA -
Substance Sediment
River area Lake area Mouth area Sea area
PFOS - -
PFOA - - -
“ ”: An inter-annual trend of decrease was found.
“ ”: Although the number of detections was small, the detection rate was decreased, it suggested a reduction tendency.
“ - ”: An inter-annual trend was not found.
【Surface water】
【Sediment】
【Wildlife】 【Air】
⚫ Guidance to provide useful information to prefectural or municipal
governments on how to take action when the concentration of PFOS and
PFOA in public water areas or groundwater exceeds the guideline value
(prepared by MOEJ and MHLW and notified to prefectures, etc. in June 2020)
⚫ Adopted to suit the local circumstances of each area
Guidance on How to Respond to PFOS and PFOA Exposure
• To encourage those who take drinking water from wells etc., to use tap water
(2) Conducting continuous monitoring surveys
(1) Conducting exposure prevention measures
• To understanding trend in monitoring results in order to consider next actions
• To expand survey areas as needed in order to ensure the implementation of
measures to prevent exposure
• To conduct surveys to identify emission sources as needed in order to take
necessary measures to reduce concentrations
10
(3) Conducting additional surveys
Measures in Cases of Accident to Prevent Water Pollution
What are Monitored Substances?
Measures in Cases of Accidents
Designation of PFOS and PFOA as Monitored Substances requiring measures in cases of
accidents under the Water Pollution Prevention Act (WPPA) (effective 1st February 2023).
• Leaks, as result of an accident (including
disasters), of water containing Designated
Substances into public waters (rivers, lakes, harbors,
coastal areas, etc.) from facilities storing, etc. such
substances (Designated Facilities).
The operator of a factory or workplace that has
Designated Facilities must
- immediately take emergency measures to
prevent the spread of contamination
- submit the report to prefectural governors
of the outline of measures taken, etc..
• Substances which are suspected of being harmful to public health or to cause damage
that is likely to negatively affect living conditions by being discharged into Areas of
Public Waters in large quantities (Paragraph 4, Article 2, WPPA)
Information providing in case of discharge of fire extinguishing foam containing PFOS, etc. into
public water areas in fire-fighting activities
• Request the cooperation of relevant ministries and industry associations to provide
information on the status of such discharges to the relevant local governments.
11
2. Further Action
12
➢ “Direction of Future Action for PFAS“ and ”Q&As about PFOS and PFOA“
were prepared and published on 31 July 2023.
• Latest scientific knowledge in Japan and foreign countries
• Environmental monitoring data in Japan
• Science based-response measures
• Information dissemination and risk communication to the public etc.
Expert Groups on PFAS
13
➢ Revision of guideline value for PFOS and PFOA for water quality were
discussed in cooperation with the Ministry of Health, Labor and Welfare.
➢ The Expert Group concluded that the current provisional guideline value (50
ng/L) should be maintained as a Monitored Substance while discussing.
(1) Expert Group on Guideline Values for PFOS and PFOA for Water Quality
(held on 24 Jan. and 16 Jun. 2023)
(2) Expert Group on Comprehensive Strategy for PFAS
(held on 30 Jan., 28 Mar., 15 Jun., and 25 Jul. 2023)
Outline of Direction of Future Actions on PFAS
(1) Strengthening of Management, etc.
• Reviewing the provisional guideline value for water quality
• Promoting further substitution of firefighting form
• Collecting and analyzing inventory in the market accurately
• Preventing discharge into the environment
Action to PFOS and PFOA
(2) Measures to be taken in areas where monitoring data exceeded the provisional
guideline values, etc.
•Preventing exposure according to “Guidance on How to Respond to PFOS and PFOA
Exposure”
•Assessing health status by local governments
(3) Risk communication
•Careful risk communication
(4) Enhancement of surveys to assess existence in the environment, etc.
•Enhancing environmental monitoring
•Studying to implement “Survey of the Exposure to Chemicals in Humans”
14
Outline of Direction of Future Actions on PFAS
<Group 1: Substances subject to elimination under the Stockholm Convention>
(1) Prioritized action to PFHxS and other candidate substances (long-chain PFCAs (PFNA))
Action to PFAS other than PFOS and PFOA
(2) Enhancement of surveys to assess existence in the environment, etc.
•Review for addition to target substances for environmental monitoring or “Survey of the
Exposure to Chemicals in Humans”
<Group 2: Other substances>
(1) Listing candidate substances to be responded at this moment
(2) Enhancement of surveys to assess existence in the environment, etc.
•Review for addition to target substances for water quality monitoring or “Survey of the
Exposure to Chemicals in Humans”
(3) Action based on the result of (2) above
•Considering the way of sound management
•Studying evaluation method as a substance group)
15
Outline of Direction of Future Actions on PFAS
Further accumulation of scientific knowledge, etc. on PFAS
◼ Continuous collection of scientific knowledge on health effects and pollution prevention
technologies as updated in Japan and foreign countries
◼ Promotion of relevant research in Japan
16
Q&As on PFOS and PFOA to address community concerns
Japan Environment and Children’s Study (JECS)
17
Recruitment
(3 years)
Follow-up
and
Analysis
FY 2010: Formulation of research protocols
Jan 2011: Start of recruitment (100,000 pregnant women)
Mar 2014: Completion of the recruitment
Pregnancy ‒ Questionnaire
‒ Collection of maternal blood, urine, and hair samples
At birth
One month
old
Childhood
and onward
Chemical analysis and long-term storage of biological samples
Multivariate analysis of the environmental factors on children’s
health including hereditary, lifestyle, and social factors
Identification of the impact of environmental factors on
children’s health
Study protocols Study organization/ regional centres
‒ Health check of the babies
‒ Collection of cord blood samples
‒ Physician’s examination and questionnaire
‒ Collection of breast milk and babies’ hair samples
‒ Physician’s examination and questionnaire
‒ Collection of children’s biological samples Programme Office
Medical Support Centre
Hokkaido
Koushin
Toyama
Kyoto
Hyogo
Tottori
Fukuoka
Miyagi
Fukushima
Chiba
Kanagawa
Aichi
Osaka
Kochi
South Kyusyu/Okinawa
* Annual budget: approx. $40 million
• JECS is a large-scale, long-term prospective cohort study to examine the impact of the exposure to
chemicals during pregnancy and childhood on children’s health.
Outline of Q&As about PFOS and PFOA
1. Properties, etc.
• A type of [PFAS] used in a wide range of applications
[PFOS] Anti-reflection agents for semiconductors, Metal plating
treatment agents, Firefighting foam
[PFOA] Fluoropolymer processing aids, surfactants
• Persistent, bioaccumulative, long-range mobility
Basic information on PFOS and PFOA
2. Health Impacts
• Animal: Effects on liver function, weight loss in young animals, etc.
• Human: Associated with increase in cholesterol levels, cancer,
effects on immune system, etc.
• No definitive knowledge of how much intake affects humans
• No confirmed cases of health effects from PFOS and PFOA in Japan
3. Regulations on PFOS and PFOA
• Prohibition of manufacturing, import, etc. in principle based on the CSCL
• Mandatory strict control of firefighting foam containing PFOS and PFOA
• Provisional guideline values (pGV) for drinking water, public water
areas, and groundwater [50 ng/L for the total of PFOS and PFOA]
4. Existence in the environment
• Environmental Survey and Monitoring of Chemicals
- Surface water, sediment, and air: inter-annual trend of decrease
- Wildlife: decrease in detection rate
⇒ Suggested trend of decrease in the environment
• Water quality monitoring as a Monitored Substances
- Public water areas and groundwater: Exceeded the pGV at total 139
points from 2019 to 2021
*Guidance to prevent water drinking in areas where the pGV was exceeded.
List of Q&As about PFOS and PFOA
Q1: Why are PFOS and PFOA strictly controlled such as banned from manufacturing and import?
Q2: Will PFOS and PFOA increase in the environment around us in the future?
Q3. I heard that PFAS is “forever chemicals”. Once these chemicals enter our bodies, will they remain in our bodies forever?
Q4. I heard that there are some areas where PFOS and PFOA are found in drinking water. Is such a case safe?
Q5: I heard that there is an international trend to set stricter guideline values for PFOS and PFOA for drinking water in the US and
other countries, etc. Isn't the provisional guideline value for drinking water in Japan (50 ng/L) too lenient?
Q6: Is there any standard for blood levels of PFOS and PFOA? Can we assess health effects of PFOS and PFOA by blood testing?
Q7. I heard that PFOS and PFOA are contained in fire extinguishers. Are they also contained in household fire extinguishers?
Q8. How have firefighting forms containing PFOS and PFOA been substituted?
Q9. I heard that PFOS and PFOA are being used for purposes other than firefighting form. Is there anything we should be aware of in
our daily lives? 18
3. Conclusion
19
Summary
20
⚫ Prohibition of manufacturing, import, etc.
✓ Designation of PFOS, PFOA and PFHxS as Class I Specified Chemical
Substances under the CSCL in 2010, 2021 and 2024 respectively
⚫ Water quality monitoring
✓ Designation of PFOS and PFOA as Monitored Substances in 2020 by
prefectural or municipal governments
✓ Establishment of the provisional guideline value for water quality in 2020
⚫ Other measures
✓ Designation of PFOS and PFOA as Designated Substances requiring
measures in cases of accidents by business operators under the WPPA
(effective February 2023)
✓ Other measures on environmental monitoring and exposure prevention
⚫ Establishment of two Expert Groups by MOEJ
⚫ Action based on the Direction of Future Actions on PFAS prepared by the
expert group in July 2023
What MOEJ expects for OECD
21
⚫ Information on risk management of PFAS
⚫ Information contributing to risk assessment of PFAS
✓ Grouping, properties, exposure, hazards, etc.; including assessment
reports by public institutions
✓ Information used to study the prioritization of PFAS, which are a diverse
group of chemicals
⚫ Information on biomonitoring
✓ Status of biomonitoring in each country including,
a. Number of participants and how the number was determined
b. Selection method of target substances (in particular, target substances
other than PFOS and PFOA and the reasons for the selection)
c. Frequency (cycle) of surveys and how the frequency was determined
d. Feasibility of HBM surveys at specific locations
e. Examples of utilization of survey results
Thank you!

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OECD Global Forum on the Environment dedicated to Per- and Polyfluoroalkyl Substances: PFAS policy in Japan | Itsuki (Suki) Kuroda

  • 1. PFAS Policy in Japan 12th February, 2024 Itsuki (Suki) Kuroda Environmental Health Department, Ministry of the Environment, Japan (MOEJ)
  • 2. 1. Management of PFAS in Japan 1
  • 3. PFOS, PFOA and PFHxS 2 PFOS (perfluorooctane sulfonic acid) PFOA (perfluorooctanoic acid) Use Firefighting foam, Metal plating treatment agents, Anti-reflection agent used in the manufacture of semiconductors, etc. Properties Persistent, Bioaccumulative, Chronic toxicity to human, flora and fauna Regulations in Japan • Prohibition of manufacturing and import, etc. in principle as Class I Specified Chemical Substances under the Chemical Substances Control Law (CSCL) (PFOS designated in 2010, PFOA designated in 2021, PFHxS designated in 2024) • Setting provisional guideline values for water quality (50 ng/L as total of PFOS and PFOA set out in 2020) PFhxS (perfluorohexane sulfonic acid) PFhxS
  • 4.  Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (CSCL: Chemical Substance Controls Law)  Enacted in 1973, last revised in June 2017  Purposes: (1) Establish a system to evaluate the properties of new chemical substances before their manufacture/import and (2) regulate their manufacture, import, and use, depending on their properties, to prevent environmental pollution caused by the chemical substances that can harm human health or damage living environment of animals and plants. Chemical Substances Control Law (CSCL) Regulates long-term toxicity to humans and impact on ecosystems through environmental exposure  Key measures • Reviewing new chemical substances before their launch (500 to 700 cases/year) • Performing environmental risk assessment on chemical substances that are already on the market (approx. 28,000 substances) • Regulates manufacture, import, and use of chemical substances depending on their properties 3
  • 5.  Substances that are persistent, highly accumulated, with long-term toxicity to humans or predators of higher trophic and specified as Class I Specified Chemical Substances by the government ordinance. 35 Substances including PCB and DDT. Preventing from discharge of persistent, high-accumulating, long-term toxic substances What is “Class I Specified Chemical Substances”?  Approval system for manufacturing/importing Class I Specified Chemical Substances  Use of Class I Specified Chemical Substances for purposes other than for test/study and essential use is prohibited.  Import of products that use the Class I Specified Chemical Substances is prohibited.  Order to collect substances and penal rules targeting the manufacturers, importers, and users who violate the laws and regulations Regulations of Class I Specified Chemical Substances Class I Specified Chemical Substances * Number of substances: as of Feb 2024 4
  • 6. PFHxS Regulations under the CSCL in response to the Stockholm Convention 5 • June 2022 : Decision SC-10/3 • August 2023 : Central Environment Council ➢ Recommendation for designation of PFHxS and its salts as Class I Specified Chemical Substances (Prohibition of manufacturing and import, etc. in principle) ➢ Recommendation to take measures on products containing PFHxS and its salts • Summer 2023 : Public consultation on the draft Cabinet Order on regulations on PFHxS and its salts based on the Recommendations • September 2023 :TBT notification, and public comments on the proposed amendments to the Decree • Mid-November 2023 : Cabinet meeting • February 2024 : Designation as a Class I Specified Chemical Substance • Mid-May 2024 : Designation, etc. of import-prohibited products in which Class I Specified Chemical substances are used.
  • 7. Environmental Quality Standards (Public water: 27 substance, Groundwater: 28 substances) Monitored Substances (Public waters: 27 substances, Groundwater: 25 substances) Surveyed Substances (136 substances) Continuous monitoring, Regulation of the discharging of effluent Significantly detected in the environment Monitored by prefectures, etc., Guidance based on guideline values Substances for which EQS are not set immediately based on detection status Environmental risk information of substances that need to be collected Information collection, Monitoring by the government Environmental Quality Standards for Water Pollution PFOS, PFOA Provisional guideline value: 50 ng/L *Provisional guideline values for drinking water quality management: 50ng/L (set out in FY2020) PFHxS PFOS, PFOA (designated in FY2013) (changed from surveyed substance in FY2020) 6
  • 8. TDI [ng/kg/day] Body Weight [kg] Daily Intake [L/day] Contribution Rate of Drinking Water [Percentage] × × = Provisional Guideline Value [ng/L] 20 ng/kg/day 50 kg 2 L/day 10 % 50 ng/L Using the same approach as when the Ministry of Health, Labour and Welfare (MHLW) set the provisional guideline values for drinking water, the following values were applied as the lowest values on the safe side based on the results of toxicity assessments conducted by various countries and organizations as of 2020. • 20 ng/kg/day for PFOS (Aus, NZ, and US): loss of body weight in young animals • 20 ng/kg/day for PFOA (US): developmental abnormalities in young animals Provisional Guideline Values for PFOS and PFOA in Water Environment Toxicity Assessment - 50 ng/L each for PFOS and PFOA - Provisional guideline value for total of PFOS and PFOA: 50 ng/L (as a safe side value) 7
  • 9. Monitoring Results of PFOS and PFOA in Japan • Total 1,477 water quality monitoring points from FY2019 – FY2021 (171 points in FY2019, 173 points in FY2020, and 1,133 points in FY2021) • Total 139 points exceeded the provisional guideline value, mainly in urban and suburban areas. *FY1999: Nationwide monitoring by MOEJ FY2020: Nationwide monitoring by MOEJ and local monitoring by municipalities FY2021: Local monitoring by municipalities 8 PFOS and PFOA (Surface water) PFOS and PFOA (Groundwater) > 1000 ng/L 500 ng/L – 1000 ng/L 50 ng/L – 500 ng/L 50 ng/L < > 1000 ng/L 50 ng/L – 500 ng/L 50 ng/L <
  • 10. 【 Environmental Survey and Monitoring of Chemicals】(FY2009 – FY2021) conducted by MOEJ ⚫ PFOS and PFOA in surface water, sediment and air: Evaluated to “An inter-annual trend of decrease was found” ⚫ PFOS and PFOA in wildlife: Evaluated to “Although the number of detections was small, the detection rate was decreased, it suggested a reduction tendency.” Trend of Monitoring Results of PFOS and PFOA in Japan 9 Substance Surface water Wildlife Air River area Lake area Mouth area Sea area Bibalves Fish Warm season PFOS - - - - PFOA - Substance Sediment River area Lake area Mouth area Sea area PFOS - - PFOA - - - “ ”: An inter-annual trend of decrease was found. “ ”: Although the number of detections was small, the detection rate was decreased, it suggested a reduction tendency. “ - ”: An inter-annual trend was not found. 【Surface water】 【Sediment】 【Wildlife】 【Air】
  • 11. ⚫ Guidance to provide useful information to prefectural or municipal governments on how to take action when the concentration of PFOS and PFOA in public water areas or groundwater exceeds the guideline value (prepared by MOEJ and MHLW and notified to prefectures, etc. in June 2020) ⚫ Adopted to suit the local circumstances of each area Guidance on How to Respond to PFOS and PFOA Exposure • To encourage those who take drinking water from wells etc., to use tap water (2) Conducting continuous monitoring surveys (1) Conducting exposure prevention measures • To understanding trend in monitoring results in order to consider next actions • To expand survey areas as needed in order to ensure the implementation of measures to prevent exposure • To conduct surveys to identify emission sources as needed in order to take necessary measures to reduce concentrations 10 (3) Conducting additional surveys
  • 12. Measures in Cases of Accident to Prevent Water Pollution What are Monitored Substances? Measures in Cases of Accidents Designation of PFOS and PFOA as Monitored Substances requiring measures in cases of accidents under the Water Pollution Prevention Act (WPPA) (effective 1st February 2023). • Leaks, as result of an accident (including disasters), of water containing Designated Substances into public waters (rivers, lakes, harbors, coastal areas, etc.) from facilities storing, etc. such substances (Designated Facilities). The operator of a factory or workplace that has Designated Facilities must - immediately take emergency measures to prevent the spread of contamination - submit the report to prefectural governors of the outline of measures taken, etc.. • Substances which are suspected of being harmful to public health or to cause damage that is likely to negatively affect living conditions by being discharged into Areas of Public Waters in large quantities (Paragraph 4, Article 2, WPPA) Information providing in case of discharge of fire extinguishing foam containing PFOS, etc. into public water areas in fire-fighting activities • Request the cooperation of relevant ministries and industry associations to provide information on the status of such discharges to the relevant local governments. 11
  • 14. ➢ “Direction of Future Action for PFAS“ and ”Q&As about PFOS and PFOA“ were prepared and published on 31 July 2023. • Latest scientific knowledge in Japan and foreign countries • Environmental monitoring data in Japan • Science based-response measures • Information dissemination and risk communication to the public etc. Expert Groups on PFAS 13 ➢ Revision of guideline value for PFOS and PFOA for water quality were discussed in cooperation with the Ministry of Health, Labor and Welfare. ➢ The Expert Group concluded that the current provisional guideline value (50 ng/L) should be maintained as a Monitored Substance while discussing. (1) Expert Group on Guideline Values for PFOS and PFOA for Water Quality (held on 24 Jan. and 16 Jun. 2023) (2) Expert Group on Comprehensive Strategy for PFAS (held on 30 Jan., 28 Mar., 15 Jun., and 25 Jul. 2023)
  • 15. Outline of Direction of Future Actions on PFAS (1) Strengthening of Management, etc. • Reviewing the provisional guideline value for water quality • Promoting further substitution of firefighting form • Collecting and analyzing inventory in the market accurately • Preventing discharge into the environment Action to PFOS and PFOA (2) Measures to be taken in areas where monitoring data exceeded the provisional guideline values, etc. •Preventing exposure according to “Guidance on How to Respond to PFOS and PFOA Exposure” •Assessing health status by local governments (3) Risk communication •Careful risk communication (4) Enhancement of surveys to assess existence in the environment, etc. •Enhancing environmental monitoring •Studying to implement “Survey of the Exposure to Chemicals in Humans” 14
  • 16. Outline of Direction of Future Actions on PFAS <Group 1: Substances subject to elimination under the Stockholm Convention> (1) Prioritized action to PFHxS and other candidate substances (long-chain PFCAs (PFNA)) Action to PFAS other than PFOS and PFOA (2) Enhancement of surveys to assess existence in the environment, etc. •Review for addition to target substances for environmental monitoring or “Survey of the Exposure to Chemicals in Humans” <Group 2: Other substances> (1) Listing candidate substances to be responded at this moment (2) Enhancement of surveys to assess existence in the environment, etc. •Review for addition to target substances for water quality monitoring or “Survey of the Exposure to Chemicals in Humans” (3) Action based on the result of (2) above •Considering the way of sound management •Studying evaluation method as a substance group) 15
  • 17. Outline of Direction of Future Actions on PFAS Further accumulation of scientific knowledge, etc. on PFAS ◼ Continuous collection of scientific knowledge on health effects and pollution prevention technologies as updated in Japan and foreign countries ◼ Promotion of relevant research in Japan 16 Q&As on PFOS and PFOA to address community concerns
  • 18. Japan Environment and Children’s Study (JECS) 17 Recruitment (3 years) Follow-up and Analysis FY 2010: Formulation of research protocols Jan 2011: Start of recruitment (100,000 pregnant women) Mar 2014: Completion of the recruitment Pregnancy ‒ Questionnaire ‒ Collection of maternal blood, urine, and hair samples At birth One month old Childhood and onward Chemical analysis and long-term storage of biological samples Multivariate analysis of the environmental factors on children’s health including hereditary, lifestyle, and social factors Identification of the impact of environmental factors on children’s health Study protocols Study organization/ regional centres ‒ Health check of the babies ‒ Collection of cord blood samples ‒ Physician’s examination and questionnaire ‒ Collection of breast milk and babies’ hair samples ‒ Physician’s examination and questionnaire ‒ Collection of children’s biological samples Programme Office Medical Support Centre Hokkaido Koushin Toyama Kyoto Hyogo Tottori Fukuoka Miyagi Fukushima Chiba Kanagawa Aichi Osaka Kochi South Kyusyu/Okinawa * Annual budget: approx. $40 million • JECS is a large-scale, long-term prospective cohort study to examine the impact of the exposure to chemicals during pregnancy and childhood on children’s health.
  • 19. Outline of Q&As about PFOS and PFOA 1. Properties, etc. • A type of [PFAS] used in a wide range of applications [PFOS] Anti-reflection agents for semiconductors, Metal plating treatment agents, Firefighting foam [PFOA] Fluoropolymer processing aids, surfactants • Persistent, bioaccumulative, long-range mobility Basic information on PFOS and PFOA 2. Health Impacts • Animal: Effects on liver function, weight loss in young animals, etc. • Human: Associated with increase in cholesterol levels, cancer, effects on immune system, etc. • No definitive knowledge of how much intake affects humans • No confirmed cases of health effects from PFOS and PFOA in Japan 3. Regulations on PFOS and PFOA • Prohibition of manufacturing, import, etc. in principle based on the CSCL • Mandatory strict control of firefighting foam containing PFOS and PFOA • Provisional guideline values (pGV) for drinking water, public water areas, and groundwater [50 ng/L for the total of PFOS and PFOA] 4. Existence in the environment • Environmental Survey and Monitoring of Chemicals - Surface water, sediment, and air: inter-annual trend of decrease - Wildlife: decrease in detection rate ⇒ Suggested trend of decrease in the environment • Water quality monitoring as a Monitored Substances - Public water areas and groundwater: Exceeded the pGV at total 139 points from 2019 to 2021 *Guidance to prevent water drinking in areas where the pGV was exceeded. List of Q&As about PFOS and PFOA Q1: Why are PFOS and PFOA strictly controlled such as banned from manufacturing and import? Q2: Will PFOS and PFOA increase in the environment around us in the future? Q3. I heard that PFAS is “forever chemicals”. Once these chemicals enter our bodies, will they remain in our bodies forever? Q4. I heard that there are some areas where PFOS and PFOA are found in drinking water. Is such a case safe? Q5: I heard that there is an international trend to set stricter guideline values for PFOS and PFOA for drinking water in the US and other countries, etc. Isn't the provisional guideline value for drinking water in Japan (50 ng/L) too lenient? Q6: Is there any standard for blood levels of PFOS and PFOA? Can we assess health effects of PFOS and PFOA by blood testing? Q7. I heard that PFOS and PFOA are contained in fire extinguishers. Are they also contained in household fire extinguishers? Q8. How have firefighting forms containing PFOS and PFOA been substituted? Q9. I heard that PFOS and PFOA are being used for purposes other than firefighting form. Is there anything we should be aware of in our daily lives? 18
  • 21. Summary 20 ⚫ Prohibition of manufacturing, import, etc. ✓ Designation of PFOS, PFOA and PFHxS as Class I Specified Chemical Substances under the CSCL in 2010, 2021 and 2024 respectively ⚫ Water quality monitoring ✓ Designation of PFOS and PFOA as Monitored Substances in 2020 by prefectural or municipal governments ✓ Establishment of the provisional guideline value for water quality in 2020 ⚫ Other measures ✓ Designation of PFOS and PFOA as Designated Substances requiring measures in cases of accidents by business operators under the WPPA (effective February 2023) ✓ Other measures on environmental monitoring and exposure prevention ⚫ Establishment of two Expert Groups by MOEJ ⚫ Action based on the Direction of Future Actions on PFAS prepared by the expert group in July 2023
  • 22. What MOEJ expects for OECD 21 ⚫ Information on risk management of PFAS ⚫ Information contributing to risk assessment of PFAS ✓ Grouping, properties, exposure, hazards, etc.; including assessment reports by public institutions ✓ Information used to study the prioritization of PFAS, which are a diverse group of chemicals ⚫ Information on biomonitoring ✓ Status of biomonitoring in each country including, a. Number of participants and how the number was determined b. Selection method of target substances (in particular, target substances other than PFOS and PFOA and the reasons for the selection) c. Frequency (cycle) of surveys and how the frequency was determined d. Feasibility of HBM surveys at specific locations e. Examples of utilization of survey results