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

1. Risk assessment

3

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

2. Alternatives Assessment

12

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

3. Accidental Risk vs. Chemical Risk

17

+ 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

24

4. Conclusion

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