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Questions and Answers Regarding Potential Health Effects Related to GenX Commented[TJMt]:Onthe web page, suggest aninitial
- paragraph before the FAQs that alerts reader to the
7/14/2017 press release that discusses the updated health
W hat assessment and sampling results. Also, refer reader to
1. _ — — webpage with latest sample results from DEQ.
is a health assessment and a health goal? Commented [TJM2]: original question sounds defensive.
The goal of the North Carolina Department of Health and Human Services (NC DHHS) is to provide timely
health information to residents and others who are concerned about potential health effects of GenX.
When there is not a federal standard and sufficient scientific information is available, NC DHHS can
develop and issue a health assessment. This assessment can include establishing a health goal,
sometimes referred to as a health screening level.
A health goal is a non -regulatory, non -enforceable level of a contaminant below which no adverse
health effects would be expected over a lifetime of exposure. Although health information is limited for
many of the newer or "emerging" perfluorinated compounds, NC DHHS has determined that as of July
14, 2017, there is sufficient scientific information to provide an updated preliminary; health assessment'_
for GenX.
NC DHHS shared an initial preliminary assessmentwith local partners on June 8, 2017, : *^ ; to
provide seine context for understanding the health risks'that could be associated with GenX at the levels
found in the Cape Fear River during 2013 2Q1fi The U.S. Environmental Protection Agency (EPA) is
working to provide -more comprehensive health'_risk information forthis chemical. However, the
tint r, 'ices timelineef for that process is not suffcient to address the urgent=public concerns raised by
identification of GenX in the public drinking water supply;_
These preliminary,assessments are based on available data and are updated
as new information becomes available. -DHHS continues to review all available health data and work
with federal agencies {EPA and the U.S. Centers for Disease Control and Prevention [CDC)) and academic
researchers to better jfiderstand the health risks associated with GenX.
2. What information did NG_QHHS use in their -its initial preliminary assessment?
In the absence of federal health guidance values for GenX "' " ' " ".S. federal 'gene`^`, NC DHHS
used GenX toxicity information ava[laiyle from the European Chemicals Agency (ECHA) to calculate a
health goal of 71,000 nanograms per lite_r-(ng/L, also referred to as parts per trillion or ppt). See
Appendix 1 for the calculation of the June 8 initial preliminary assessment using the information from
ECHA.
3, Why did NCOMMS update 4s prellminwy assss&p4entwhat is NC DHHS's updated preliminary health
assessment?
North Carolina Department of Health and Human Services DRAFT July 14, 17 AM/PMt 1:16 PM 4,
Commented [TJM3] Just making sure preliminary is the
right word here. That word makes it sound like a
primary/final assessment is coming, though we're likely
looking at ongoing updates.
Commented [TJM4]: Suggest using consistent
terminology to avoid confusion. For example:
*Initial preliminary health assessment --- Jun8
*Updated preliminary health assessment - July 14
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Since sharing the initial health assessment, NC DHHS has continued to review all available health
information about GenX. Based on this review,,and_ continuing discussions, and a more recent
consensus with EPA, NC DHHS has determined that sufficient additional data are available to update
Gwthe _initial preliminary health assessment.
The revised health goal is 140 ng/L for the most vulnerable population- i.e. bottle-fed infants, the
population that drinks the largest volume of water per body weight. NC DHHS established Aadditional
goals we Fe also bliske^' for older children, breastfeeding women, pregnant women and adults—a4d t
Their respective health goals range from 380 — 640 ng/L. Goals for each of these groups are presented
in Appendix 4.
This eeuiseEi-updated health �oallev 4 is lower than the level in the initial assessment for several reasons,
including the following:
After consultation with EPA, a different set of animal studies was identified as an appropriate
starting point for the assessment. This change lowered the health screening level by 10-fold.
Since the new starting point was based on short-term rather than long-term (chronic) animal
studies, an additional uncertainty factor was added, -which lowered the level by another 10-fold.
While the initial assessment assumed thdrtnkidg water was the only source of exposure, the
`afi
revised estimate includes an assur*0_ t that only 20%of a person's GenX exposure comes from
drinking water, lowering the level another 5-fold. EPA's practice is to use thisThls 20% default
factor as4s a generic assumption •s^' ; •'e-`„ It lay4he ` -A when information is lacking about
other sources of exposure in the environment as is currently the ease with.GenX. NC DHHS's use
of the 20% factors and was included based on additional review and consultation with EPA. Commented [TJM5]: Suggest edits to clarify the 20
factor, which could give the wrong impression that HHS
thinks drinking water exposure is only 20% of the exposure
Details of the specific updates and t;aidu(ations forthe revised health screening level are to GenX
presented in Append!". Formatted: Indent: Left: 0.5", No bullets or numbering
Formatted: No bullets or numbering
As with the initial preliminary assessment, it is important to note that this updated preliminary risk
assessment is not final id[sf kely to be revised as new information becomes available or when health
goals or standards are made available by the EP)
4. What does the revised
For the most vulnerable people in the population (bottle-fed infants), the revised health 44,health
assessment means that no adverse non -cancer health effects would be expected over a lifetime of
consuming water with GenX levels at or below 140 ng/L. tThere could be an increased risk of adverse
non -cancer health effects over a lifetimeof consuming water with GenX levels greater than 140 ng/L.
Because this geal{)evetheaith i;oai'is calculated based on the most vulnerable population, it is the most
conservative and is protective of any group, including pregnant women, nursing mothers, children as
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Commented [TJM6]: Suggest helping lay readers
understand this by further explaining how the 140 level for
infants is for lifetime of consumption. Infants aren't infants
for their lifetime. My understanding is that the 140 applies to
infant while they are infants; then the <6 years -old health
goal applies.
Commented [TJM7]: Suggest using consistent
terminology throughout document: health goal or health
screening level.
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well as older adults. See Appendix 4 for age group calculations and provisional levels for other
population including older children breastfeeding women pregnant women and adults .
This revised health assessment is based on evolving toxicological data; therefore, it is still considered
provisional and is subject to further updates based on an ongoing review, consultation with federal
agencies and other partners, and the introduction of new research and scientific information.
^4-,41he initial health goal was based upon combined cancer and noncancer endpoints. The
revised health goal is based upon animal studies that included non -cancer endpoints only. Based on
conversations with EPA, we -NC DHHS concluded there currently is not enough information ate
to identify a specific level of GenX that might be associated with an increased risk for cancer.
S. Does NC DHHS recommend that people stop using the municipal water for drinking or other
purposes?
NC_DHHS is not recommending that people stop using the municipal water for drinking or other
purposes. There currently is not enough information about the human health effects of GenX or related
chemicals to make such a recommendation for the general population or for any specific group -It -this
time. Individuals are encouraged to consider in€ormatron mthe updated preliminary health risk
assessment when making decisions about water ase. The poten, ial health effects from these chemicals
should be balanced against the health benefits,of municipal water, including routine monitoring for a
variety of microbial and known chemical contarmipants that could be present in private wells or other
unregulated sources. NC DHHS supports all efforts eliminfite sotircesofGenXand related chemicals in
the water supply.
6. Does this mean
A -The GenX healtfi=g_*Js not a boundary line
Rather, it is a level -that represents the concer
effects would be anticipated --_over an entire lif
7. Is it safe to eat fish from the-C-ape_ Fear Riv
i a "safe" and "dangerous" level of a chemical.
if GenX at which no adverse non -cancer health
exposure to the most sensitive population.
There are no fish advisories related io'";n Preliminary information from EPA suggests that GenX is not
anticipated to bioaccumulate in fish. A list of statewide and location -specific fish advisories related to
other contaminants is available at http://epi.publichealth.nc.gov/oee/fish/advisories.html.
8. Is health information available for other emerging perfluorinated compounds found in the Cape
Fear River?
In discussions with EPA and other partners, there are not sufficient identified data that can be used to
develop a preliminary health risk assessment for the other newer or "emerging" perfluorinated
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compounds mentioned in the 2016 paper by Sun et al (PF02HxA, PFMOAA, PFMOBA, PF030A,
PFMOPrA and PF04PA). This applies for exposure to these' compounds individually and in combination. - Commented [TJM8]: Given the public's concern with
Scientific information such as animal toxicology studies and laboratory testing standards are needed by exposure to the family ofperflowinated compounds in
combination, I think the public would find it helpful for the
these agencies to conduct further health assessment on the other perfluorinated compounds. FAQ to address that issue.
9. Is health information available for 1,4-dioxane?
Health information about 1,4-dioxane is available at http://deq.nc.gov/about/divisions/water-
resou rces/water-resources-data/water-scie n ces-home-page/1-4-dioxane.
10. Is NC DHHS working with other agencies [or researchers? Commented [TJM9]: Should mention work with DEQ in
this answer. It is an agency HHS is working with.
Yes. NC DHHS has been in close contact with officials at EPA and the CDC to gather and review all health
information related to GenX. EPA is working to develop a health risk assessment for GenX; however, the
timeframe for that assessment is not known. NC DHHS staff are also in contact with academic
researchers with knowledge and experience with these compounds.
Department of Environmental Quality?
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Appendix 1: Calculation of the Initial Preliminary Assessment
The European Chemical Agency (ECHA) information included a Derived No Effect Level (DNEL) of 0.01
mg/kg body weight (bw)/day for oral exposures. The ECHA assessment was performed using a no -
observed -adverse -effect -level (NOAEL) from a 2-year rat chronic toxicity/carcinogenicity study as the
point of departure (POD) and applying default uncertainty factors, as described below:
No -observed -adverse -effect -level (NOAEL) =1.0 mg/kg body weight (bw)/day
Total default uncertainty factors (UF) =100 (interspecies variability = 10; intraspecies
variability = 10)
Formula: NOAEL/UF = DNEL
(0.01-rng1kg1day) X $tcgj(11L/day) X'1.0X 106 ng/mg = 71,000 ng/L
NOTE: ng/L can also be expressed as parts per trillion or ppt
The values used for bodyweight and drinking wafer intake were based on infants in order to be
maximally protective, since infaas consume the West amount of water in relation to their body
weight. The initial calculation assumed that 10"-of GenX exposure (relative source contribution) was
from water consumption. DWEL Is the same as -a health goal or health screening level.
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Appendix 2: Calculation of the Revised Health Assessment
After consultation with EPA, the following were updated:
Sufficient data are available to support the use a lower no -observed -adverse -effect -level
(NOAEL) as a point of departure for the assessment. This NOAEL (0.1 mg/kg/day) is 10-fold lower
than the NOAEL used in the initial assessment and is based on effects on the liver in mice.
Since this point of departure is based on a subchronic toxicity study rather than a chronic
toxicity study, an additional uncertainty factor of 10 is included in the calculations.
A relative source contribution (RSC) of 20% is used to account for potential exposure to GenX
from other routes like air and food. The RSC lowers the acceptable concentration in water due
to the potential for other exposure routes.
Revised calculation:
No -observed -adverse -effect -level (NOAEL) = 0.1 mg/kg body weight (bw)/day
Total default uncertainty factors (UF) =1000 (interspecies variability = 10; intraspecies
variability =10; and subchronic to chronic vafiamity_=10)
Formula: NOAEL/UF = Reference Dose {RfD)
(0.1 mg/kg L*iYJ/1000 =
NC DHHS calculated a drinking water equivale
(0.0001 mg/kg/d6) X 7 8kM1.1 L/day) X 0.2 X 106 ng/mg =140 ng/L
NOTE: ng/L can also be expressed as parts per trillion or ppt
The values used for body weight and drinking water intake were based on bottle-fed infants in order to
be maximally protective, since infants consume the highest amount of water in relation to their body
weight. See Appendix 4 for other age groups see table below. DWEL is the same as a health goal or
health screening level.
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Appendix 3: References
Beekman M, Zweers P, Muller A, de Vries W, Janssen P, Zeilmaker M. 2016. RIVM Report 2016-0174:
Evaluation of substances used in the GenX technology by Chemours, Dordrecht.
http://www.rivm.nl/Documenten en publicaties/Wetenschappeliik/Rapporten/2016/december/Evalua
tion of substances used in the GenX technology by Chemours Dordrecht.
ECHA Toxicological Summary for Ammonium 2,3,3,3-Tetrafluoro-2-(Heptafluoropropoxy)Propanoate.
https:Hecha europa eu/registration-dossier/-/registered-dossier/2679/7/1
Ferreira et al. Comparing the potency in vivo of PFAS alternatives and their predecessors. March 2017.
http:Hsu diva -portal org/smash/record isf?pid=diva2%3A1085755&dswid=-5295#sthash.lofaSrDn.dpbs
Gannon et al. Absorption, distribution, metabolism, excretion, and kinetics of 2,3,3,3-tetrafluoro-2-
(heptafluoropropoxy)propanoic acid ammonium salt following a single dose in rat, mouse, and
cynomolgus monkey. Toxicology 340 (2016) 1-9. http://dx.doi.org/10,1016/i.tox.2015.12.006
Hoke et al. Aquatic hazard, bioaccumulation and screerriri risk assessment for ammonium 2,3,3,3-
tetrafluoro-2-(heptafluoropro poxy)-propanoate. Chemospere 149 (2016) 336-342.
http://dx.doi.org/10.1016/i.chemosphere.24DI6.01.009
Rae et al. Evaluation of chronic toxicity and t�genicity of arninonium_2,3,3,3-tetrafluoro-2-
(heptafluoropropoxy)-propanoate in SpragueLID i leq racalogy Rep*!r June 2015.
https://doi.org/10.1016/i.toxrep.2015.06.001 _
Sun et al. Legacy and Emerg hg Perfluoroa 1 Substances Ate Important Drinking Water Contaminants in
the Cape Fear River Watershed of North Carolina, Environmental Science & Technology Letters. Nov
2016. DOI 10.1021%acs,estlett.6b00398.
USEPA. Drinking WateP Hea##h_Advisories for PFOA and PFOS. https://www.epa.gov/ground-water-and-
drinking-water/drinking water-fiealth-advisories-pfoa-and-pfos
USEPA. TSCA Non -Confidential Bu§1*10�Infarmafion for 8EHQ-06-16478.
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Appendix 4: Calculation of population -specific provisional screening levels
GenX
Point of
0.
mg/
NOAEL for subchronic mice
Departure
1
kg/
studies
day
OF total
10
unit
10 interspecies; 10 intraspecies;
00
Tess
10 subchronic to chronic
DRAFT RfD
0.
mg/
POD/UF
00
kg/
01
day
Relative 0. unit Assumes 20% of dose comes
Source 2 less from drinking water to account
Contribution for other potential exposure,-
(RSC) pathways
Screening level = [(Reference Dose (mg/k ay) * RSC
Body weight (kg)) / Intake rate (L/day)j
Adult
80 a
a
-0.00064
640
Pregnant
73 n
2.5
0.00056
560
Women
89
Lactating
73 °
3.5
0.00041 _
410
Women
88
Child
(birth to
15 a
$ a
0.00038
380
<6 years)
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Infants
(birth to
7.8
1.1
0.00014
140
12
e
13 `
months)
I EPA OSWER Directive 9200.1-120 [EPA 2014]
n EPA EFH Table 8-29: 50th percentile for all pregnant
women [EPA 20111
`EPA EFH Table 3-3: 95t" percentile for consumers only
[EPA 2011]
a Exposure dose guidance from ATSDR: EPA EFH Table 8-5:
Weighted average of 501^ percentile body weight for
females 15-45 years of age + 5kg retained during lactation
(Janney et al. 1997; Moya et al. 2014) [ATSDR 2016a, EPA
2011, Janney et al. 1997, Moya et al. 2014]
e EPA EFH Table 8-1: Weighted average of mean body
weight from birth to 12 months [EPA 2011, ATSDR 2016a]
t EPA EFH Table 3-1: Weighted average of 95`h percentile
for consumers only from birth to 12 months [EPA 2011,
ATSDR 2016b]
References
[ATSDR 2016a] Agency for Toxic Substances and Disease Registry. 2016. Exposure Dose Guidance for Body Weight. Atlanta, GA: U.S. Department of
Health and Human Services, Public Health Service, October 26.
[ATSDR 2016b] Agency for Toxic Substances and Disease Registry. 2016. Exposure Dose Guidance for Water ingestion, Version 2. Atlanta, GA: U.S.
Department of Health and Human Services, Public Health Service, October 26.
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