evaluation of pfoa and pfos for human health standards...mar 25, 2020 · evaluation of pfoa and...
TRANSCRIPT
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Evaluation of PFOA and PFOS for human health standards
Sarah Yang, Ph.D.
Groundwater Toxicologist
Meghan Williams, M.S.
Environmental Toxicologist
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Today’s presentation
Basis for human health standards
Groundwater standard process
Recommended groundwater standard for PFOA
Recommended groundwater standard for PFOS
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Standards are set to protect
health of Wisconsin residents.
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Most human health standards are based on toxicology studies conducted in research animals.
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Health Outcomes
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Dose response experiments are used to figure out how much of a chemical is needed to cause an effect.
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Dose
Response
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Most effects have a threshold.
There is some level below which these effects are not expected to occur
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NOAEL No Observable Adverse Effect LevelHighest tested dose without a response
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LOAEL Lowest Observable Adverse Effect LevelLowest tested dose with a response
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Cancer effects are usually considered to not have a threshold.
Any level can increase the cancer risk.
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Cancer slope factor = cancer risk per unit of dose
0%
50%
25%
10%
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Toxicology studies called dose response experiments are used to figure out how much of a chemical is needed to cause an effect.
NOAEL LOAEL Cancer slope factor
Most human health standards are based on toxicology studies conducted in research animals.
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Toxicology data are used to set standards that protect health
of Wisconsin residents.
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Groundwater
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Two-thirds of Wisconsin residents use groundwater.
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Enforcement Standard
Preventive Action Limit
Wisconsin’s groundwater standards have 2 parts.
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DNR
Identify substances of concern
DHS
Develop recommended standards
Promulgate standards
DNR
Groundwater standard process
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DNR
Identify substances of concern
DHS
Develop recommended standards
Promulgate standards
DNR
Groundwater standard process
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The enforcement standard is established from available health information.
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Enforcement standards can be based on:
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EPA value
Federal number
State drinking water standard
Technical information
Cancer risk
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Enforcement standards can be based on:
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Federal number
Concentration of a chemical in drinking water that is established by the EPA.
Maximum contaminant level (MCL)
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Maximum contaminant level (MCL) The highest level of a contaminant that is allowed in drinking water.
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Maximum contaminant level (MCL) is the highest level of a contaminant that is allowed in drinking water.
Maximum contaminant level goal (MCLG) The level of a contaminant in drinking water below which there is no known or expected risk to human health.
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Maximum contaminant level (MCL)
Maximum contaminant level goal (MCLG)
is set as close to
as feasible.
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0MCLG
Most carcinogens
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MCLG
Body weight
Reference dose
Relative source contribution
Water consumption
All other substances
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Enforcement standards can be based on:
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Federal number
Concentration of a chemical in drinking water that is established by the EPA.
Maximum contaminant level (MCL)
Health advisory
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Health advisoryLevel at which health effects are not anticipated to occur over a specified duration
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1 day
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Health advisories
10 day
Lifetime
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Health advisory
Body weight
Reference dose
Relative source contribution
Water consumption
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Enforcement standards can be based on:
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Federal number
Concentration of a chemical in drinking water that is established by the EPA.
Maximum contaminant level (MCL)
Health advisory
Concentration based on cancer risk level
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Concentration based on
cancer risk level
Body weight
Water consumption
Risk level
Cancer slope factor
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Enforcement standards can be based on:
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Concentration of a chemical in drinking water that is established by the DNR.
Maximum contaminant level in Wis. Admin Code NR 809
State drinking water standard
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Enforcement standards can be based on:
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Amount of a chemical a person can be exposed to every day without health effects.
Oral reference dose
Acceptable daily intake (ADI)
EPA value
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Oral reference dose
Toxicity value
Uncertainty factor
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Available dataStudy limitations
PeopleSpecies
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Uncertainty factors
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Enforcement standards can be based on:
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DHS can establish an ADI from available scientific information when:
There is no federal number or EPA value.
The information was not considered when the federal number/EPA value was established.
Technical information
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Acceptable daily intake
(ADI)
Toxicity value
Uncertainty factor
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Enforcement standards can be based on:
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DHS must ensure the standard does not allow for unacceptable cancer risk.
Cancer riskMore than 1 case in 1,000,000 people
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When an enforcement standard is based on:
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Federal number
State drinking water standard
Use the concentration as the standard
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When an enforcement standard is based on:
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Calculate the appropriate standard
EPA value
Technical information
Cancer risk
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Enforcement standards based on
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EPA value
Technical information
Set to protect a young child
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Body weight
Acceptable daily intake
Water consumption
Relative source contribution
Enforcement Standard
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Body weight
Acceptable daily intake
Water consumption
Relative source contribution
Enforcement Standard
10 kg
Specified in Statute
1 L/d
100%
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Enforcement standards based on
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Cancer risk
Set to protect from a lifetime of exposure
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Enforcement Standard
Body weight
Water consumption
Risk level
Cancer slope factor
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Enforcement Standard
Body weight
Water consumption
Risk level
Cancer slope factor
10-6
Specified in Statute
80 kg
2.4 L/d
Recommended by EPA
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The preventive action limit is set at a percentage of the enforcement standard.
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Preventive action limit
10%
Substances that cause carcinogenic, mutagenic, teratogenic, or interactive effects
of the enforcement standard
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Preventive action limit
20% All other substances
of the enforcement standard
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PFOA52
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Perfluorooctanoic acid
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Cancer risk
Technical information
EPA value
Federal numberAvailable scientific information for PFOA:
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EPA value
Federal number
State drinking water standard
Technical information
Cancer risk
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Available scientific information for PFOA:
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Federal number
Lifetime health advisory
70 ng/L for PFOA and PFOS
Established in 2016
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Available scientific information for PFOA:
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Federal number
Concentration based on cancer risk
500 ng/L for PFOA
1 in 1,000,000 risk
Established in 2016
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EPA value
Available scientific information for PFOA:
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Oral reference dose
20 ng/kg-d
Established for use in setting the lifetime health advisory
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Available scientific information for PFOA:
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Intermediate minimum risk level (MRL)
3 ng/kg-d
Proposed by ATSDR in 2018
Exposure duration of 15 –365 days
Technical information
ATSDR = Agency for Toxic Substances and Disease Registry
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Available scientific information for PFOA:
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Critical studies
Toxicity studies
Modeling studies
Technical information
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Cancer risk
Available scientific information for PFOA:
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Cancer slope factor
0.07 (mg/kg-d)-1
Established by EPA to set the concentration based on cancer risk
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Cancer risk
Technical information
EPA value
Federal numberAvailable scientific information for PFOA:
61
State drinking water standard
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62
In 2016, EPA established a combined health advisory of 70 ng/L for PFOA and PFOS.
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63
200+ studies evaluating PFOA toxicity in research animals
Most common endpoints:
54
48
31
18
18
11
Liver
Body weight
Development
Immune system
Reproduction
Neurology
Adapted from Figure 2-1 (ATSDR PFAS Tox Profile)
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69
Liver
Body weight
Development
Immune
Reproduction
Neurology
LOAEL ranges from non-acute studies
10.01
5 100
200.002
30
140.002
305
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70
Liver
Body weight
Development
Immune
Reproduction
Neurology
LOAEL ranges from non-acute studies
Development and reproduction are the most sensitive effects.
10.01
5 100
200.002
30
140.002
305
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71
Babies are most sensitive to the effects of PFOA.
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72
EPA based their advisory on a reproductive study in rats.
0 1 3 5 10 20 40mg/kg-d PFOA
Study selected was Lau et al., 2006
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73
0 1 3 5 10 20 40
mg/kg-d PFOA
Reproduction
Key findings
Summarized from Lau et al., 2006
Increased percent of animals with full litter resorption
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74
0 1 3 5 10 20 40
mg/kg-d PFOA
Reproduction
Offspring survival No births
Key findings
Summarized from Lau et al., 2006
Reduced percent survival based on number of implantations per animal
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75
0 1 3 5 10 20 40
mg/kg-d PFOA
Reproduction
Offspring survival
Bone formation No births
Key findings
Summarized from Lau et al., 2006
Decreased number of ossification sites in forelimb proximal phalanges
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76
0 1 3 5 10 20 40
mg/kg-d PFOA
Reproduction
Offspring survival
No births
Key findings
Summarized from Lau et al., 2006
Altered preputial separation
Sexual development
Bone formation
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77
0 1 3 5 10 20 40
mg/kg-d PFOA
Reproduction
Offspring survival
Key findings
Summarized from Lau et al., 2006
Sexual development
Bone formation
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78
We do not know how much PFAS has to be in our blood to cause health effects.
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79
21 days
840 days
PFOA stays in people longer than animals.4 days
Half-life of PFOA in males
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80
PFOA?
PFOA level in pregnant woman’s blood
PFOA level in mother rat’s blood at the dose that caused the critical effect in offspring
EPA’s approach
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81
PFOA
Estimate Convert Calculate
EPA’s approach
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82
PFOA
Estimate Convert Calculate
Estimate how much PFOA was in animal’s blood at the dose that caused the critical effect
EPA’s approach
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83
PFOA
Estimate Convert Calculate
Convert to human dose using half-life and amount of blood in the body
EPA’s approach
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84
PFOA
Estimate Convert Calculate
EPA’s approach
Calculate the health advisory
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85
Health advisory
Body weight
Reference dose
Relative source contribution
Water consumption
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86
We have learned more about PFOA since 2016.
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87
PFOA can cross the placenta during pregnancy.
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PFOA can pass through breastmilk.
88
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89
How can we best protect unborn and breastfed babies?
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90
PFOA?
Kieskamp et al. approach
PFOA level in offspring’s blood that caused the critical effect
PFOA level in baby’s blood
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91
PFOA
Estimate Convert
Kieskamp et al. approach
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92
PFOA
Estimate Convert
Kieskamp et al. approach
Estimate how much PFOA was in the blood of the offspring that had the critical effect.
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93
PFOA
Estimate Convert
Converted to dose that would cause a baby to have the same level as the offspring – taking into effect half-life and breastfeeding duration
Kieskamp et al. approach
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94
Acceptable daily intake
(ADI)
Toxicity value
Uncertainty factor
DHS calculations for PFOA:
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95
Acceptable daily intake
(ADI)
Toxicity value
Uncertainty factor
DHS calculations for PFOA:
540 ng/kg-d Human equivalent dose for breastfeeding duration of 12 months and half-life of 2.3 years
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96
Acceptable daily intake
(ADI)
Toxicity value
Uncertainty factor
DHS calculations for PFOA:
300
Accounts for differences between species, differences among people, and using a LOAEL.
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97
Acceptable daily intake
(ADI)
Toxicity value
Uncertainty factor
DHS calculations for PFOA:
540 ng/kg-d
300
2 ng/kg-d
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98
Body weight
Acceptable daily intake
Water consumption
Relative source contribution
Enforcement Standard
10 kg
1 L/d
100%2 ng/kg-d
Specified in Statute
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99
Enforcement Standard
20 ng/L
DHS recommendation for PFOA
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100
Preventive action limit
10%
PFOA has been shown to cause carcinogenic, teratogenic, or interactive effects
DHS recommendation for PFOA
of the enforcement standard
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101
DHS recommends a combined enforcement standard of 20 ng/L for PFOA and PFOS.
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PFOS102
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103
Perfluorooctane sulfonate
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Technical information
EPA value
Federal numberAvailable scientific information for PFOS:
104
EPA value
Federal number
State drinking water standard
Technical information
Cancer risk
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Available scientific information for PFOA:
105
Federal number
Lifetime health advisory
70 ng/L for PFOA and PFOS
Established in 2016
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EPA value
Available scientific information for PFOS:
106
Oral reference dose
20 ng/kg-d
Established for use in setting the lifetime health advisory
160.01(3)
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Available scientific information for PFOS:
107
Intermediate minimum risk level (MRL)
2 ng/kg-d
Proposed by ATSDR in 2018
Exposure duration of 15 –365 days
Technical information
ATSDR = Agency for Toxic Substances and Disease Registry
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Cancer risk
Technical information
EPA value
Federal numberAvailable scientific information for PFOS:
108
State drinking water standard
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109
In 2016, EPA established a combined health advisory of 70 ng/L for PFOA and PFOS.
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110
Babies are most sensitive to the effects of PFOS.
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111
EPA based their advisory on a 2-generation study in rats.
0 0.1 0.4 1.6 3.2
mg/kg-d PFOSStudy selected was Luekber et al., 2005b
F1F0 F2
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112
mg/kg-d PFOS
Body weight (F0)
Key findings
Summarized from Luebker et al., 2005b
Reduced body weight in males and females at various timepoints during exposure -corresponding with reduced food consumption
0 0.1 0.4 1.6 3.2
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113
mg/kg-d PFOS
Body weight (F0)
Key findings
Summarized from Luebker et al., 2005b
Increased in number of pups found dead and decreased viability and lactation indices.
0 0.1 0.4 1.6 3.2
Survival (F1)
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114
mg/kg-d PFOS
Body weight (F0)
Key findings
Summarized from Luebker et al., 2005b
Decreased weight per litter and reduced weight change per litter
0 0.1 0.4 1.6 3.2
Survival (F1)
Body weight (F1)
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115
mg/kg-d PFOS
Body weight (F0)
Key findings
Summarized from Luebker et al., 2005b
Decreased weight per litter and reduced weight change per litter
0 0.1 0.4 1.6 3.2
Survival (F1)
Body weight (F1)
Body weight (F2)
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mg/kg-d PFOS
Body weight (F0)
Key findings
Summarized from Luebker et al., 2005b
0 0.1 0.4 1.6 3.2
Survival (F1)
Body weight (F1)
Body weight (F2)
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117
PFOS
Estimate Convert Calculate
EPA used the same modeling approach for PFOA and PFOS.
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118
We have learned more PFOS since 2016.
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119
PFOS can cross the placenta during pregnancy.
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PFOS can pass through breastmilk.
120
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121
PFOS may increase the risk for asthma, food allergies, and certain infectious diseases.
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122
In 2018, ATSDR proposed a minimum risk level of 2 ng/kg-d for PFOS.
ATSDR = Agency for Toxic Substances and Disease Registry
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123
Minimum risk level
Toxicity value
ATSDR’s calculation for PFOS:
Modifyingfactor
Uncertainty factor
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Minimum risk level
Toxicity value
ATSDR’s calculation for PFOS:
Modifyingfactor
Uncertainty factor
510 ng/kg-d
Human equivalent dose for pregnant women
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125
Minimum risk level
Toxicity value
ATSDR’s calculation for PFOS:
Modifyingfactor
Uncertainty factor
Account for differences between species and differences among people
30
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126
Minimum risk level
Toxicity value
ATSDR’s calculation for PFOS:
Modifyingfactor
Account for potential for immune effects at low levels
Uncertainty factor
10
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127
Minimum risk level
Toxicity value
ATSDR’s calculation for PFOS:
Modifyingfactor
Uncertainty factor
10
510 ng/kg-d
30
2 ng/kg-d
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DHS recommends using ATSDR’s minimum risk level for PFOS.
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This approach protects from potential immune effects and infant exposure.
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Body weight
Acceptable daily intake
Water consumption
Relative source contribution
Enforcement Standard
10 kg
1 L/d
100%2 ng/kg-d
Specified in Statute
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Enforcement Standard
20 ng/L
DHS’ recommendation for PFOS
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Preventive action limit
10%
PFOA has been shown to cause carcinogenic, teratogenic, or interactive effects
DHS’ recommendation for PFOS
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DHS recommends a combined enforcement standard of 20 ng/L for PFOA and PFOS.
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Thanks!
Sarah Yang, Ph.D.Groundwater Toxicologist
Bureau of Environmental and Occupational HealthDivision of Public Health
Wisconsin Department of Health Services
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Additional information can be found on DHS’ webpage: dhs.wisconsin.gov\water\gws.htm
The full scientific support document for all of the Cycle 10 compounds is available here: dhs.wisconsin.gov\publications\p02434v.pdf.
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Additional information
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5 1810.01
10020 3030105
0.5 55552 3 50.3 10.30.01 30.30.10.01 0.3 53 203 50.002
30
142 145510.002
305
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Liver
Body weight
Development
Immune
Reproduction
Neurology
LOAELs from non-acute studies
Data from Table 2-3 in ATSDR’s Toxicological Profile for Perfluoroalkyls
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Lau et al., 2006 results (part 1)
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Effects observed in mothers
Dose (mg/kg-d)
1 3 5 10 20 40
Body weight Reduced maternal weight gain ✓ ✓
Reproduction
Increased percent of dams with full litter resorption
✓ ✓ ✓ ✓
Reduced number of live fetuses ✓ N/A
Increased percent of prenatal loss ✓ N/A
Increased time to parturition ✓ ✓ ✓ N/A
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Effects observed in offspringDose (mg/kg-d)
1 3 5 10 20
Survival Reduced neonatal survival ✓ ✓ ✓
Body weight Reduced fetal body weight ✓
Bone
development
Decreased number of ossification sites in sternebrae, caudal vertebrae, metacarpals,metatarsals
✓
Decreased number of ossification sites in forelimb proximal phalanges
✓ ✓ ✓ ✓
Decreased number of ossification sites in hindlimb proximal phalanges
✓ ✓ ✓
Reduced percent ossification in calvaria ✓ ✓
Reduced percent ossification in supraoccipital ✓ ✓
Reduced percent ossification in unossified hybrid ✓
Increased number of enlarged fontanel ✓ ✓ ✓
Lau et al., 2006 results (part 2)
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Summary of epidemiological studies located during the literature review for PFOS
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Effects observed in offspringDose (mg/kg-d)
1 3 5 10 20
Birth defectsIncreased percent of tail defects ✓ ✓ ✓
Increased percent of limb defects ✓ ✓
Heart Increased percent of microcardia ✓ ✓
Development Delayed eye opening ✓ ✓ ✓
Delayed vaginal opening ✓ ✓
Delayed first estrus ✓ ✓
Altered preputial separation ✓ ✓ ✓ ✓ ✓
Lau et al., 2006 results (part 3)
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Leubker et al., 2005 results (part 1)
141
Effects observed in F0 generation (males)
Dose (mg/kg-d)
0.1 0.4 1.6 3.2
Body weight Reduced body weight ✓a
✓b
Food
consumption
Reduced food consumption days 1-42 ✓ ✓
Reduced food consumption days 56-63 ✓ ✓ ✓
a. Days 56 through terminationb. Days 36 through termination
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Leubker et al., 2005 results (part 2)
142
Effects observed in F0 generation (females)
Dose (mg/kg-d)
0.1 0.4 1.6 3.2
Body weight Reduced body weight during precohabitation ✓c
Reduced body weight during gestation ✓d✓
e
Reduced body weight during lactation ✓f
✓g
Food
consumption
Reduced food consumption during premating and gestation ✓
Reduced food consumption during lactation ✓ N/A
Reproduction Reduced gestation duration ✓
Decreased implantation sites per delivered litter ✓
Increased percent of animals with stillborn pups ✓
Increased percent of animals with all pups dying (PND 1-4) ✓
c. Days 15-42d. Gestation days 3-10e. Gestation days 0-20Lactation day 7f. Lactation day 1; no results for days 4-21
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Leubker et al., 2005 results (part 3)
143
Effects observed in F1 generation
Dose (mg/kg-d)
0.1 0.4 1.6 3.2
Survival Decreased liveborn ✓
Increased stillborn per litter ✓
Increased percent of pups found dead ✓g ✓
h
Reduced viability index ✓ ✓
Reduced lactation index ✓ N/A
Body weight
Decreased weight per litter ✓i
✓j
Reduced weight change per litter ✓k N/A
g. Postnatal days 2-4 and 5-7h. Postnatal day 1 and 2-4; not results for days 5-21i. Postnatal days 1-21j. Postnatal day 1; no results for days 2-21k. Postnatal days 1-4; 4-7; 7-14; 14-21
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Leubker et al., 2005 results (part 3)
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Effects observed in F2 generation
Dose (mg/kg-d)
0.1 0.4
Body weight Reduced weight per litter ✓l
Reduced weight change per litter ✓m
l. Postnatal days 7 and 14m. Postnatal days 4-7 and 7-14