Accidental Risk vs. Chemical Risk
– Consumer Perspectives
Kiyotaka TSUNEMI
National Institute of Advanced Industrial
Science and Technology (AIST)
BSEF Asia Forum 2018, Intercontinental Hotel, Yokohama, Japan
5th November 2018
1
1. Risk assessment
2. Alternatives Assessment
3. Accidental Risk vs. Chemical Risk
4. Conclusion
Contents
2
Risk Assessment for Chemical Substance: Framework
Exposure assessment
Hazard identification
Risk characterization
Risk management
Hazard assessment
Risk assessment
Emission estimation
Dose-response assessment
4
Non cancer risk characterization
MOE, Margin of exposure
vs
UF: Uncertainty Factor
DecaBDE
Human intake = 1.05×10-6 mg/kg/day (total intake from various spheres)
NOAEL = 1120 mg/kg/day(long-term toxicity test, rat, 2 years)
UF = 100(10: inter-species, 10: individual difference)
MOE = 1120mg/kg/day ÷ 1.05×10-6mg/kg/day
= 1.1×109 >>UF (100-1000)
→no significant risk
MOE Intake
= NOAEL (No Observed Affected Effect Level)
MOE > UF: There is no possible risk.
MOE < UF: There is a possible risk.
(AIST, 2005)
5
Differences between EU Risk Assessment Report and AIST Report
DecaBDE
Risk Subject EU report (2008) AIST report (2005)
Ecologi
cal risk
Aquatic organisms
(secondary poisoning)
There is a need for further
information and/or testing.
A more widespread monitoring
project to determine whether the
finding in top predators is a
widespread or localised
phenomenon, and trends.
-
Sediment organisms There is no need for further
information and/or testing and no
need for risk reduction measures.
-
Soil organisms
(secondary predators)
ditto -
Human
health
risk
Workers There is no need for further
information and/or testing and no
need for risk reduction measures.
-
Consumers ditto -
Humans exposed via
the environment
ditto There is no
significant risk.
6
EU Risk Assessment Report
Risk Subject pentaBDE(2001) octaBDE(2003) TBBPA(2006)
Ecologi
cal
risks
Aquatic
organisms
There is a need for limiting
the risks of secondary
poisoning arising from use
in polyurethane foams.
There is a need for further
information or testing
(secondary poisoning).
There is no need for
further information or
testing.
Sediment
organisms
ditto ditto ditto
Soil
organisms
ditto ditto ditto
Human
health
risks
Workers Concern for effects on liver
at polyurethane foam
manufactory.
There is a need for further
information or testing
(liver effect).
ditto
Consumers There is no need for
further information or risk
reduction measures.
There is no need for
further information or risk
reduction measures.
ditto
Humans
exposed via
the
environment
No concern for risk but
high bioaccumulation
through milk ingestion.
More information required.
There is a need for further
information or testing
(extent of excretion into
the breast milk and cow's
milk).
ditto
Other brominated flame retardants
7
GreenScreen Benchmarks for the Constituents and Decomposition Products
of decaBDE
Substance Type Chemical
Substance
Benchmark
decaBDE Constituents decaBDE 2
Breakdown
products
octaBDE 1:Very high persistence, high
developmental effects
pentaBDE 1:Very high persistence and
bioaccumulation, high acute and
chronic ecotoxicity, high systemic
organ effects, and high endocrine
disruption
Benchmark 1: Avoid-Chemical of High Concern.
(Rossi & Heine,2007)
8
These monitoring data suggest that decaBDE might be degraded to
lower brominated congeners in the environment, which underestimates
risk of decaBDE.
Therefore, cumulative risk assessment of PBDEs as complex mixtures
should be performed.
Use of flame retardants in Japan
0% 20% 40% 60% 80% 100%
Air
Deposit dust
Soil
Water
Sediment
Aquatic organism
Terrestrial organism
Meal
House dust
Ratios of PBDEs concentrations
2,4,4’-TetraBDE 2,2’,4,4’-TetraBDE 2,2’,4,4’,6-PentaBDE
2,2’,4,4’,5-PentaBDE 2,2’,4,4’,5,6’-HexaBDE 2,2’,4,4’,5,5’-HexaBDE
2,2’,3,4,4’,5’,6-HeptaBDE 2,2’,3,4,4’,5,5’,6-OctaBDE 2,3,3’,4,4’,5,5’,6-OctaBDE
DecaBDE
0
5000
10000
15000
20000
25000
1986 1988 1990 1992 1994 1996 1998 2000 2002
year
Consu
mption v
olu
me
of
flam
e re
tard
ants
(t/y
ear)
DecaBDE OctaBDE TetraBDE Ethane-1,2-bis Ethylene bis TBBPA epoxy oligomer
Monitoring data in Japan
DecaBDE main use in PBDEs Lower brominated congeners of PBDEs
Risk Assessment of decaBDE together with its Decomposition Products
Tsunemi,2007 9
(Tsunemi,2007)
RPF (Relative potency factor) approach for PBDEs
Toxicity level RPF Endpoint Route of exposure
•Absorption
•Oral intake
•Dermal intake
•Microscopic changes
in the livers
•PBPK
•BMD
•NOAEL
•RfD
•PentaBDE
•OctaBDE
•DecaBDE
•Other
congeners
•The same as
PentaBDE
•No toxicity
Toxicologic similarity
Mode of action
•Thyroid effects
•Liver enzyme
induction Scenario identification
Scenario Toxicity of other congeners Endpoint RPF
No toxicity The same as PentaBDE
Liver enzyme induction
Microscopic changes in the livers
RfD NOAEL
1 ○ ○ ○
2 ○ ○ ○
3 ○ ○ ○
4 ○ ○ ○
5 ○ ○ ○
6 ○ ○ ○
7 ○ ○ ○
8 ○ ○ ○
10
(Tsunemi,2007)
Estimation of Cumulative Risk of PBDEs
MOE(decaBDE only)
= 1120mg/kg/day ÷ 1.05×10-6mg/kg/day
= 1.1×109 >>UF (100-1000)
→ no significant risk
Maximum MOE(Total PBDEs)
= 1.1×109 ÷ 11,500
= 9.6×104 >>UF (100-1000)
→ no significant risk
Likely MOE(Total PBDEs)
= 1.1×109 ÷ 5,000
= 2.2×105
Scenario MOEdecaBDE
/MOE total PBDEs
1 12
2 30
3 4,500
4 11,500
5 2,700
6 4,100
7 3,800
8 6,200
(Tsunemi,2007)
11
Risk Concerns about Substitution by Alternative Substances
Total risk of
substance A
Risk reduction by
reducing the emission of
substance A
Increase in the risk of substance B
Risk trade-off
Sufficient information Less information
Substitution by a substance having
less information
Risk assessment
decaBDE (decabromodiphenyl ether) (HIPS Resin)
BDP Condensed phosphoric acid ester
(PC/ABS Alloy resin)
13
Scenario Setting
Risk comparison from the long-term view using countermeasure scenarios that are based on
actual situations that use substance substitution
①In case alternatives are employed, decaBDE (baseline)
scenario
②In case alternatives are employed, BDP (baseline) scenario
③Without alternatives, decaBDE fictional scenario
Change of demand over years for each scenario Method of Scenario Comparison
Demand
decaBDE ,
BDP
Alternatives are employed
① ②
decaBDE,
alternatives are employed
③
alternatives are employed
Quality difference of the alternative
scenarios used Risk
Alternatives are
not employed
③
Alternatives
are employed
(baseline)
①+②
14
Risk Trade-off Assessment by Substitution Scenario
QALY loss (days/lifetime of a person) was calculated from average estimated intake
(residents in the Tokyo-Yokohama area)
Alternatives available (actual situation) No alternatives
(hypothetical case)
①decaBDE、②BDP、TPP ③decaBDE
average case 95% worst case
Effects on
liver << 0.001
(2.8×10-57) << 0.001
(2.0×10-53) << 0.001
(9.5×10-57) Effects on
kidney << 0.001
(1.4×10-140) << 0.001
(1.0×10-122) << 0.001
(8.8×10-137)
Total << 0.001
(2.8×10-57) << 0.001
(2.0×10-53) << 0.001
(9.5×10-57)
Risks are very small whether an alternative substance is used or not.
→ Relative risks cannot justify or deny the use of an alternative substance.
15
Cost-benefit analysis of substance substitution
Comparison of the costs to implement risk reduction measures in order to prolong
Quality-Adjusted Life Year by 1 year in Japan.
1100
2.2
1.5
0.4
2.2
1.E-01 1.E+00 1.E+01 1.E+02 1.E+03 1.E+04 1.E+05
臭素系難燃剤からリン系難燃剤への代替
鉛はんだから鉛フリーはんだへの代替
自主管理経過における1,3-ブタジエン削減
ごみ処理施設でのダイオキシン類恒久対策
シロアリ駆除剤クロルデンの禁止
ガソリン中ベンゼン含有率の規制
QALY1年獲得費用(億円/年)
1.E+49
Regulation of gasoline’s benzene content
Prohibition of the termite insecticide,
chlordane
Long-term measures to reduce dioxin
emission at waste treatment facilities
Reduction of 1, 3-butadiene emission as
part of the self-management by facilities
Replace lead solder with lead-free solder
alternatives
Replace brominated flame retardant
with phosphorus frame retardant
Expense for prolonging QALY by 1 year (100 million yen/year)
This revealed that
(i) the advantage of substance substitution is only a little reduction in the risks and
(ii) the substitution might cause a huge amount of extra cost at the national level.
16
+ chemical risk
Without FR With FR Risk trade-off
Reference Content Fire risk Chemical risk
Simonson
et al., 2006
Increases or decreases in
damage caused by TV fires
with or without flame
retardants in Europe
Risk reduction
saving 1,050-
1,49054-63 million
dollars a year
A cost increase of 110-
393 million dollars a
year
Inoue et al.,
2010
Increases or decreases in
damage caused by TV fires
with or without flame
retardants in Europe
Risk reduction
saving 54-63 billion
yen a year
A cost increase of 3-12
billion yen a year
Δ fire risk
Δ fire risk > + chemical risk
Risk trade-offs between fires and chemical substances
18
We especially pay attention to long-term risk of “health” and “environment” and
short-term risk of “safety” and “welfare”, and conducted comparative evaluation.
19
Long-term and short-term risks
Questionnaire survey
Questionnaire survey was conducted on
consumers’ preference to accidental risk and
chemical risk focused on flame retardants
(FRs) used or not used in plastic parts of
electric and electronic home appliances.
We also would like to grasp a change of risk
acceptance by consumers after watching a
video which indicates the effect of flame
retardant.
Hierarchical structure of AHP for product selection
Production selection
Health Environment
Product with FR Product with non-FR
Safety Welfare
Level 1: object
Level 2: evaluation criteria
Level 3: alternatives
20
BSEF video (television fire safety)
21
Subjects
Number of responses :N=1420 (March 2018)
Number of AHP valid responses :N=1319
( Subjects who answered all weighted responses as "intermediate" were excluded )
Male Female
18 to 29 30 to 39 40 to 49 50 to 59 60 to 99
(years old)
No children under 18 years old 1 to 6
Elementary school
Junior high school
High school
Others Under 1 years old
Owner's house
Others
Lease house
(thousand USD)
less than 20
20 to 40 40 to 60 60 to 80
80 to 100
100 to 150 150 to 200
Over 200
22
Result Numerical priority of evaluation criteria
Before watching the video After watching the video
**
**
*
Health Environment Safety Welfare Health Environment Safety Welfare
Nu
me
rica
l p
rio
rity
Two-sided test, alternative hypothesis:
“Before watching the video” ≠ “After watching the video”
*:P<0.05 **:P<0.01
(N=1420, March in 2018)
Product selection
重要度
Before watching the video After watching the video
Num
erical priority
Product with FR Product with non-FR
Welfare
Product with FR Product with non-FR
Health
Environment
Safety
23
Conclusion
The reduction in fire risks is larger than the increased chemical risk
using flame retardants.
Consumers has consciousness to avoid accidental risk in preference
to avoid chemical risk.
The degree of consumer’s preference to the product including FR
increased after watching the video.
25
1. Risk assessment
There is no significant risk of decaBDE.
There is also no significant risk considering of decaBDE degraded to lower brominated congeners in the environment.
2. Alternative assessment
The advantage of substance substitution from decaBDE to other flame
retardant is only a little reduction in the risk.
The substitution might cause a huge amount of extra cost at the national
level.
3. Accidental risk vs. chemical risk