Professional Documents
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Ceh Reply in Support of Intervention in Third Circuit
Ceh Reply in Support of Intervention in Third Circuit
No. 22-2287
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TABLE OF CONTENTS
ARGUMENT ............................................................................................................. 1
CONCLUSION ........................................................................................................ 12
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TABLE OF AUTHORITIES
Cases
NRDC v. Costle,
561 F.2d 904 (D.C. Cir. 1977) .........................................................................9
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Wayne Land & Mineral Grp., LLC v. Del. River Basin Comm’n,
959 F.3d 569 (3d Cir. 2020) ............................................................................2
Rules
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law consent order requires Chemours to provide clean drinking water to affected
also be stymied from educating the public and advocating restrictions on GenX.
ARGUMENT
practically disadvantaged’” to protect their interests, not just those “‘who would be
legally bound as a matter of res judicata.’” Kleissler v. U.S. Forest Serv., 157 F.3d
964, 970 (3d Cir. 1998). Indeed, courts have “cautioned against requiring that a
re N.Y.C. Policing During Summer 2022 Demonstrations, 27 F.4th 792, 801 (2d
Cir. 2022); La Union del Pueblo Entero v. Abbott, 29 F.4th 299, 305 (5th Cir.
“cognizable legal right.” See EPA Br. 17, 20; accord Town of Chester v. Laroe
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Estates, Inc., 137 S. Ct. 1645, 1651 (2017) (clarifying that intervenors seeking
different relief from plaintiffs must suffer a legal injury sufficient for standing);
Wayne Land & Mineral Grp., LLC v. Del. River Basin Comm’n, 959 F.3d 569,
574-75 & n.6 (3d Cir. 2020) (implying that intervenors pursuing the same relief as
Movants qualify for intervention because they have “an interest that is
substantially concrete fashion by the relief sought.” Kleissler, 157 F.3d at 972; see
Chemours Opp. 13. However, “that hundreds or thousands (or even millions) of
other persons may have suffered the same injury does not change the
Moreover, Movants have specific and unique interests that differentiate them
from the general Cape Fear population and will be impaired if the Advisory is
vacated. See Mot. Intervene 15-20 (citing declarations). The individual Movants
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drink water from municipal systems or private wells with GenX contamination
exceeding the 10 ppt Advisory level and thus are at personal risk of the health
the 2019 state-law consent order to which Chemours, the North Carolina
Watch (CFRW) are parties. Sussman Decl. Ex. 1 (Consent Order ¶ 19) (MA-65).
CFRW participated in negotiating the order to protect the interests of its members,
many of whom drink water with GenX levels exceeding the Advisory level. Suppl.
any private well with GenX contamination at levels exceeding “140 [ppt], or any
Order ¶ 19) (MA-65) (emphasis added). When EPA issued the Advisory, NCDEQ
immediately lowered the trigger for supplying the paragraph 19 remedies to 10 ppt
(July 13, 2022 Chemours Letter) (MA-95-96), if Chemours prevails here, it may
refuse to provide replacement water for private wells with GenX between the
Advisory level of 10 ppt, and the level otherwise required by the consent order,
140 ppt. See Mot. Intervene 18-20. Considering the adverse health effects of GenX
exposure, this backsliding will expose users of well water to a heightened risk of
harm. Recent analysis of sampling data by CFRW shows detections of GenX levels
between 10 and 139 ppt in 2566 private wells in counties subject to the consent
order. Suppl. Sargent Decl. ¶ 10. Owners of these wells (including CFRW
members and Movant Debra Stewart) have a significant interest in preserving the
Advisory does not force it to provide any additional drinking water protection.
reverse osmosis systems available under paragraph 20 are less effective in reducing
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filtration system—the remedies available under paragraph 19. Suppl. Sargent Decl.
¶¶ 15-18. Municipal water suppliers in the Cape Fear basin are installing treatment
technology that can reduce GenX below detectable levels, well beyond the
water are treated, not just the three sinks that would be equipped with reverse
osmosis under paragraph 20. Id. ¶¶ 15-16. Thus, homeowners would be protected
from GenX exposure from sinks and other water outlets without reverse osmosis
systems, e.g., in bathrooms, showers, laundry rooms, garages, and outdoors. See id.
all sinks can support under-sink units, which is why Movant Debra Stewart still
lacks access to clean water, even though she is entitled to an under-sink system
provide more benefits and long-term protection than the paragraph 20 remedy of
under-sink systems, benefits that are important to eligible residents. See Suppl.
Sargent Decl. ¶¶ 15-18. These stronger remedies would become unavailable if the
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remedies to all eligible well owners could cost Chemours up to $238 million. See
id. ¶ 14.1
EPA argues that even if Movants’ access to safe water would be jeopardized
should Chemours prevail, the consent order still would not create “any legal right
case. EPA Opp. 17-20. This Court rejected similar reasoning in Kleissler, where
environmental groups challenged U.S. Forest Service logging plans under the
National Environmental Policy Act (NEPA). 157 F.3d at 967-68, 973. The Court
allowed school districts and municipalities to intervene, even absent direct rights
under the federal logging plans or NEPA, because they were guaranteed certain
revenues from logging operations under state law. Id. at 973. The Court concluded
that the intervenors had a “direct, substantial” interest “protected by state law”
because, if the logging plans were vacated, “they w[ould] lose” access to timber
revenues “state law” guaranteed to them. Id. Here, the consent order, which is
enforceable under state law, guarantees private well owners significant increased
Advisory. Vacatur of the Advisory would negate this right to safe drinking water.
1
Despite Chemours’s insistence that no “public health crisis” exists in the Cape
Fear basin, Chemours Opp. 8, the Advisory identifies many health risks from
GenX exposure. Advisory at 20. Chemours claims that North Carolina health
statistics show an absence of elevated cancers in affected counties, but state
officials have reached the opposite conclusion. Suppl. Sargent Decl. ¶ 22.
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Thus, Movants have shown a more specific and unequivocal nexus between their
interests and the subject of this case than “the mere fact that a lawsuit may impede”
their rights in a separate suit. See Mountain Top Condo. Ass’n v. Dave Stabbert
an interest by entering into the consent order, EPA Opp. 17, Movant Debra Stewart
was not party to the order, yet her well is contaminated, Stewart Decl. ¶ 5 (MA-
33), and Chemours will likely refuse to provide her replacement water if the
Advisory is vacated.
advocate for greater protections against GenX pollution also suffice for
information. See Friends of Animals v. Jewell, 824 F.3d 1033, 1041 (D.C. Cir.
2016); Asbestos Disease Awareness Org. v. Wheeler, 508 F. Supp. 3d 707, 716-18
(N.D. Cal. 2020). EPA’s insistence that vacating the Advisory would not harm
these interests is implausible. EPA Opp. 13. As EPA recognizes, the purpose of
health advisories is to inform and educate states, local governments, and the public,
underlying them. EPA Opp. 14. A judicial finding that the Advisory is based on
flawed science or is procedurally flawed would diminish its persuasive value, and
Movants would spend time and money reconstructing its conclusions and
EPA’s argument that Movants lack a protectable interest because EPA was
not required to issue the Advisory is a red herring: EPA has issued the Advisory,
and the interest Movants advance is to preserve its continued value for advocacy
and education. Whether a statute required EPA to produce the Advisory may be
Chemours’s challenge.
Demonstrations, 27 F.4th 792, 800 (2d Cir. 2022), to argue that Movants’ interest
assumes the Advisory is scientifically sound, which is a merits issue in this case.
Chemours Opp. 15. To the contrary, that case holds that courts cannot presume
intervention is warranted.
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EPA and Chemours misguidedly argue that because Movants and EPA seek
the same outcome and EPA’s justification for the Advisory will be the sole basis
cannot be inadequate. See EPA Opp. 14-15; Chemours Opp. 19. This argument
by Federal Rule of Appellate Procedure 15(d), which does not distinguish between
Council Tree Commc’ns, Inc. v. FCC, 619 F.3d 235 (3d Cir. 2010); Gulf Oil Corp.
v. FERC, 706 F.2d 444 (3d Cir. 1983); see also NRDC v. Costle, 561 F.2d 904, 912
(D.C. Cir. 1977) (appellants’ intervention warranted despite their and EPA’s
Here, Movants could offer several legal and scientific arguments for
upholding the Advisory that would likely differ from EPA’s.2 If the Court does not
dismiss this case, it would be the first to examine the legal framework for Safe
2
Indeed, in past cases, Movants’ interests have diverged from the government’s on
scientific and legal issues concerning chemical risk assessments. See, e.g., Safer
Chems., Healthy Families v. EPA, 943 F.3d 397 (9th Cir. 2019).
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Drinking Water Act health advisories, including any administrative procedures that
may be required for issuing them and which judicial review standard applies to
EPA’s scientific and policy judgments. See Murray Energy Corp. v. EPA, 936 F.3d
597, 611 (D.C. Cir. 2019) (differentiating between deference owed to scientific
judgments and policy judgments). EPA and Movants’ interests may diverge
flexibility and deference, whereas Movants are interested in the maximum health
Movants will approach these issues from the narrower perspective of specific
For example, the Advisory estimates the health risks from exposure to GenX
protective and urged EPA to account for “simultaneous exposure to other PFAS
chemicals that impact the same target organs.” Bhat Decl. Ex. 1, p. 5 (Comment
Advisory level is too low, the Court may benefit from Movants’ perspective that
the science warranted a more conservative methodology than EPA used, which
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GenX. Chemours Opp. 6. Although EPA will likely insist that its exposure
methodology was reasonable, Movants may show that EPA should in fact have
been more conservative. For example, EPA relied on exposure estimates for
lactating women, Advisory at 21, whereas if it had based the Advisory on exposure
to infants, a more vulnerable population with higher exposure, the Advisory level
would have been lower. Bhat Decl. Ex. 1, p. 12 (Comment Letter at 12); Advisory
at 18.
Further, Movants and EPA may attach different weight to the importance of
filling data gaps on GenX’s health effects. EPA applied “uncertainty factors” to
account for incomplete test data, Advisory at 14, an issue Chemours intends to
uncertainty factors, they also urged EPA to “strengthen this assessment” through
relying on a more robust data set. Bhat Decl. Ex. 1, p. 1 (Comment Letter at 1).
Indeed, Movants are directly adverse to EPA on this very issue in a separate
challenge to EPA’s decision not to grant Movants’ petition asking EPA to order
further GenX testing. Bhat Decl. Ex. 2, p. 14-16 (Complaint, Ctr. For Envt. Health
v. Nishida, No. 7:22-cv-00073-M (E.D.N.C.), Doc. No. 1 ¶¶ 54, 58). There, EPA
has asserted that the requested additional testing on GenX is unnecessary. Id.
Chemours may contend that this position conflicts with EPA’s selection of
uncertainty factors here, in which circumstance Movants would not be able to rely
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on EPA to vigorously defend the uncertainty values from the same perspective as
United Mine Workers, 404 U.S. 528, 538 n.10 (1972) (emphasis added) (internal
CONCLUSION
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Sarah C. Tallman
IL Bar No. 6310294
Natural Resources Defense Council
1152 15th Street NW, Suite 300
Washington, DC 20005
Telephone: 312-651-7918
[email protected]
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(6), I certify that Times New Roman, a proportionally spaced serif font, in size 14,
in plain, roman style type, with italics for emphasis and case names, was used for
certify that this motion is 2,598 words, excluding the accompanying documents
authorized by Rule 27(a)(2)(B), which is within the word limit of 2,600 words.
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CERTIFICATE OF SERVICE
Appellate Rule 27.2, I certify that this Motion to Intervene and accompanying
Motion Appendix was filed electronically through the court’s docketing system.
All parties to this case are Filing Users and are served electronically by the Notice
of Docket Activity.
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of Cape Fear River Watch (CFRW), other organizations and several individuals to intervene in the
Chemours’ petition to review the drinking water health advisory for GenX chemicals issued by the
issues addressed in the Chemours’ Brief In Opposition to Motion to Intervene, filed on December
16, 2022.
3. First, I describe CFRW’s extensive role in negotiating and implementing the February
2019 consent order between North Carolina Department of Environmental Quality (NCDEQ),
4. Second, I explain the impact of the EPA health advisory for GenX on the remedies
available to owners of contaminated private wells under the consent order. As I show, Chemours
is incorrect that incorporation of the EPA advisory in the order does not affect the level of health
protection afforded well owners exposed to GenX. In fact, the advisory is critical to reducing
epidemiology studies that GenX and other Per- and Polyfluoroalkyl Substances (PFAS) from
Chemours’ Fayetteville Works have harmful health effects. In fact, as I show below, the exact
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CFRW Has Been Extensively Involved in All Aspects of the Consent Order
6. CFRW has played a comprehensive role has in all aspects of the 2019 consent order. CRFW
sued Chemours in August of 2018 for violations of the Clean Water Act and Toxic Substances Control
Act, and also sued the North Carolina Department of Environmental Quality (NCDEQ) for failure to
uphold their legal responsibilities under state environmental laws. In September 2018, NCDEQ filed
its own suit against Chemours in state court based on alleged violations of North Carolina law and
regulations. CFRW sought intervention to protect the interests of its members and both NCDEQ and
Chemours consented to our motion. As a party, CFRW was then closely involved in negotiating and
signing the comprehensive 2019 consent order, which is legally binding on Chemours and enforceable
by the Bladen County Superior Court. The order resolves both NCDEQ’s and CFRW’s suits against
Chemours.
7. The order is structured to maximize CFRW’s role in ensuring that its requirements are met
by Chemours. Paragraph 40 of the order stipulates that “Chemours shall provide quarterly progress
reports submitted to DEQ concurrently to Cape Fear River Watch. Within thirty (30) days of
receiving those reports, DEQ shall make relevant staff available for an in person meeting with Cape
Fear River Watch to discuss the status of Chemours' performance of its obligations under the Consent
Order and DEQ's review of any relevant submissions.” Pursuant to these provisions, CFRW has been
an active and ongoing participant in all aspects of the order’s implementation, expressing its views
repeatedly on how key provisions of the order should be carried out and raising concerns about non-
compliance by Chemours. If the health advisory is overturned, the improvements in the safety of our
drinking water for which CFRW has tirelessly worked under the consent order will be severely
compromised.
The EPA Health Advisory Strengthens Remedies for GenX Contaminated Drinking Water
Under the 2019 North Carolina Consent Order
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consent order requires Chemours to provide permanent drinking water replacement in the form of
public water or whole-house filtration for any household, business, school or public building with
a private drinking water well found with an exceedance of “140 ppt of GenX, or any applicable
health advisory, whichever is lower…” (emphasis added). This provision was intended to
condition the availability of replacement drinking water on non-compliance with the provisional
health goal for GenX of 140 parts per trillion (ppt) set in 2018 by North Carolina’s Department of
Health and Human Services (NCDHHS) but to reduce the replacement water trigger if EPA, or
another regulatory agency, issued a more stringent health advisory for GenX. Thus, finalization of
the EPA health advisory in June of 2022 lowered the trigger for permanent drinking water
the 10 ppt level as “an applicable health advisory” under paragraph 19 of the consent order and, in
a June 15, 2022 letter to Chemours, directed it to develop a supplemental compliance plan under
the order for providing replacement water systems to private well owners with GenX
in its July 15 letter responding to NCDEQ’s directive and informed NCDEQ that “[a]s of July 8,
2022, there were 1697 residences or other properties in Cumberland, Bladen, and Robeson
counties with wells that have been tested and found to have [GenX] levels between 10 ppt and 140
ppt.”
10. Data obtained since that letter indicates that, based on sampling performed through
October 2022, there are now 2,566 private wells with GenX between 10 and 139 ppt in the
aforementioned counties as well as lower Cape Fear counties of New Hanover, Brunswick, Pender
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and Columbus, for which sampling began in April of 2022. As required by the consent order,
Chemours should be offering either public water or whole-house filtration (granular activated
carbon or GAC) to the owners of these wells. All parties – including Chemours, NCDEQ and
CFRW – have understood that private well owners are now entitled to protections against GenX-
contaminated water that were not available under the order before incorporation of the EPA health
advisory.
11. However, Chemours’ Opposition denies that “well users with concentrations between the
Health Advisory level (10 ppt) and the North Carolina level (140 ppt) can now get replacement
drinking water supplies because of the health advisory, but could not get replacement supplies
otherwise.” Opposition at 7-8 (emphasis in original). To support this argument, Chemours points
to the availability under paragraph 20 of the order of under sink reverse osmosis systems (RO) to
private well owners with levels of GenX or certain other PFAS of 10 ppt or above. It claims that
this “means that any private well that has HFPO Dimer Acid above 10 ppt was already entitled to
entitled, regardless of what this Court does with the Health Advisory” (emphasis in original).
12. This is an inaccurate description of the consent order provisions. Chemours is now
offering remedies to private well owners under paragraph 19 by virtue of the health advisory that it
is not obligated to provide under paragraph 20. In fact, paragraph 20 states explicitly that
Chemours must install and maintain “three under sink reverse osmosis drinking water systems
approved by [the Department of Environmental Quality] for any party . . . that does not qualify for
permanent replacement of a private drinking water supply pursuant to paragraph 19” (emphasis
added). Thus, paragraph 20 does not merely duplicate paragraph 19 but is a back-up mechanism to
provide more limited assistance to private well owners who are ineligible for the stronger
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13. This is clear from a comparison of the remedies available under paragraphs 19 and 20.
Installation of reverse osmosis under a sink in accordance with paragraph 20 does not provide a
new source of water to the well owner but merely reduces contaminants in the existing well-
supplied water source. By contrast, paragraph 19 requires Chemours to “establish and properly
maintain permanent replacement drinking water supplies in the form of public water or a whole
building filtration system for any party (i.e., household, business, school, or public building) with
a [qualified] private drinking water well.” The paragraph specifies that “permanent replacement
water supplies shall be established by connection to a public water supply” unless such a
connection is “cost-prohibitive” (capped at $75,000 per well) or the well owner “elect[s] to receive
either a whole building filtration system approved by DEQ or under sink reverse osmosis
systems.” Where a connection to a public water supply is installed, Chemours “shall be liable to
pay for any water bills from public utilities for a period of twenty (20) years up to
$75/month/affected party.” These subsidies for replacing private well water with municipal water
are not available to residents under paragraph 20. Their availability under paragraph 19 for GenX
contamination between 10 and 140 ppt is a direct consequences of the EPA 10 ppt drinking water
14. By our calculations, the cost to Chemours to provide municipal water connections to the
2,566 well owners who have GenX concentrations from 10 ppt to 139 ppt could be up to $238
million – and that number will rise as more wells are sampled. This estimate is based on consent
order requirements and includes $46 million alone for paying water bills ($75/month x 12
months/year x 20 years x 2,566 wells) and up to more than $192 million for the cost of municipal
hookups ($75,000/well x 2,566 wells). The cost for installation and maintenance of GAC at 2,566
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homes (and counting) would far outweigh that of RO, based on the materials, sampling and
maintenance outlined in the attached Chemours Carbon Implementation Plan (Attachment 1).
15. Chemours’ position assumes that it makes no difference to residents with GenX-
contaminated private wells whether they receive reverse osmosis systems or a connection to public
water and whole building filtration. However, reverse osmosis installed under paragraph 20 would
only reduce GenX levels in up to three sinks in kitchens or bathrooms and only if reverse osmosis
units fit into available under-sink spaces. Chemours would have no obligation under paragraph 20
to provide reverse osmosis for sinks in other bathrooms or laundry rooms or for other water outlets
such as baths and showers, dishwashers and clothes washers and outdoor hoses.
16. By contrast, a whole house filtration system would provide treatment for all water
sources within or attached to the dwelling, resulting in more comprehensive protection from GenX
exposure. A public water connection would also afford a higher level of protection because
municipal water supplies generally have lower PFAS levels than private wells and unlike
by utilities in the Cape Fear basin are reducing the presence of PFAS in tap water to near non-
detect levels. 1
17. Along with concerns about exposure and health, RO systems may substantially depreciate
the value of homes because contaminated wells will remain the sole source of water.
Additionally, RO systems generate a large amount of water waste, essentially sending the PFAS
contaminated water back into the environment. This simply recycles PFAS contamination back
into the water supply system, making others responsible for filtering the water and adding to the
1
See Sweeney’s new filters remove PFAS from water: Authority, CoastalReview.org (Oct. 11, 2022),
https://coastalreview.org/2022/10/sweeney-plants-new-filters-remove-pfas-from-water-authority/.
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ecological damage of PFAS on the environment. Further, those on septic systems are advised not
to use RO for concern that it will overwhelm the system. In addition, RO systems are cumbersome
and inconvenient due to the lack of water pressure and the system’s inability to maintain a steady
stream for more than a few gallons at a time. In fact, a Wilmington resident and business owner
who has taken up activism to support the community of well owners recently drafted a letter to
members of the NCDEQ, the utility and public officials highlighting the concerns about the
deficiencies of RO systems in protecting him and other well owners from the proven hazards of
18. Residents continuously voice concerns to CFRW and at DEQ community meetings
about showering or bathing their children in PFAS, or swimming in pools filled with it, or eating
food grown with PFAS-contaminated water and eating food off of dishes washed in it. RO does
not address these PFAS pathways and their contribution to PFAS exposure is significant. For
example, data from a recent study “suggest that PFOA is dermally absorbed and that under certain
conditions the skin may be a significant route of exposure.” 2 In another study, perfluorooctanoic
acid (PFOA), formerly produced at the Chemours Fayetteville facility, “was demonstrated to be
OVA, suggesting that PFOA exposure may augment the IgE response to environmental
allergens.” 3 In addition, there are multiple studies supporting concern for PFAS exposure through
crops grown in contaminated water supplies. For example, a 2020 study states that “Hazard
2
Jennifer Franko, B. J. Meade, H. Frederick Frasch, Ana M. Barbero, Stacey E. Anderson, Dermal
Penetration Potential of Perfluorooctanoic Acid (PFOA) In Human And Mouse Skin, J. Toxicol.
Environ Health A., 2012;75(1):50-62, DOI: 10.1080/15287394.2011.615108.
3
Kimberly J. Fairley et al., Exposure to the Immunosuppresant, Perfluorooctanoic Acid, Enhances the
Murine IgE and Airway Hyperreactivity Response to Ovalbumin, Toxicol Sci. 2007 Jun; 97(2):375-83,
DOI: 10.1093/toxsci/kfm053.
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analyses using real-world PFAS-contaminated groundwater data for a hypothetical farm showed
estimated exposures to most PFASs exceeding available or derived RfDs, indicating water-to-crop
water.” 4 In fact, just this week, I have been in contact with an organic farmer in New Hanover
County, whose well is contaminated with 60 ppt of combined PFAS This farmer has stopped
selling his produce and eggs for fear that he is poisoning his customers, when, in his words, his
goal in building an organic farm was to provide healthy and safe food for his community.
19. In its original letters to owners of the private wells sampled starting in April 2022 in
lower Cape Fear River counties, Chemours did not provide full information about available
paragraph 19 remedies. CFRW reached out to NCDEQ and after several weeks, Chemours agreed
to revise the letters. Even in the revision, Chemours left out the option of a whole-house GAC
filtration system when explaining the options available to those with GenX contamination of 10
ppt or above. It was only after CFRW sent yet another request to NCDEQ that it required
20. CFRW has been analyzing the NCDEQ compilation of PFAS sampling data for the lower
and upper river counties. CFRW used public records act requests to NCDEQ to obtain Chemours’s
sampling data in the form of Excel spreadsheets, which we analyzed. 5 As shown in our map, 6 data
4
Assessing Human Health Risks from Per- and Polyfluoroalkyl Substance (PFAS)-Impacted Vegetable
Consumption: A Tiered Modeling Approach, Juliane B. Brown, Jason M. Conder, Jennifer A. Arblaster,
and Christopher P. Higgins, Environmental Science & Technology 2020 54 (23), 15202-15214
DOI: 10.1021/acs.est.0c03411.
5
Chemours’ sampling data, submitted to NCDEQ are available at
https://edocs.deq.nc.gov/WasteManagement/Browse.aspx?id=1736157&dbid=0&repo=WasteManagem
ent (last visited January 13, 2023).
6
Available at https://www.arcgis.com/home/webmap/viewer.html?webmap=98ea0b36e94f417eaecf55df
5f915efb&extent=-79.2707,33.4837,-75.214,35.3573. To see the sample data, click “Details,” then the
icon labeled “Show Contents of Map.” From there, click on “Fayetteville Sample Sites (10-139 ppt)”
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through September 2022 for the Fayetteville region and through October 2022 in the Lower Cape
Fear region identifies 2,504 wells in the Fayetteville region and 62 private wells in the Lower
Cape Fear with GenX levels at or above the EPA health advisory but below the previous trigger
for replacement water supplies under paragraph 19. Sampling is ongoing in both regions as
required by the consent order so these totals will undoubtedly continue to rise. If the advisory were
no longer a factor in determining the remedies available under paragraph 19, the impact on
residents who use these private wells would be widespread and severe – they would have higher
levels of GenX in the water they are drinking and greater risks of the harms to health on which the
21. Chemours’ Opposition also denies that “there is a public health crisis in areas that draw
drinking water from the Cape Fear River.” Opposition, at 8-10. However, the EPA health
advisory itself provides compelling evidence of the many adverse health effects linked to GenX
exposure, Chemours also states that “ there are no epidemiological data showing an increased risk of
cancers attributable to exposure to HFPO Dimer Acid, including in the counties surrounding the
Fayetteville facility” and that “[e]pidemiological evidence actually points the other way.” because a
N.C. Department of Health and Human Services analysis “found no trends of increased cancer risk in
the counties with water allegedly impacted by HFPO Dimer Acid originating from the
22. Chemours made similar statements in its unsuccessful request to EPA under the Information
Quality Act (IQA) to withdraw the GenX toxicity assessment on which the health advisory is based,
and “LCF Sample Sites (10-139 ppt),” and then the icon labeled “Show Table.” LCF refers to “Lower
Cape Fear.”
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Chemours argued that the State’s analysis of cancer rates in NC counties showed lower rates in counties in
the vicinity of the Fayetteville plant. In a May 3, 2022 letter to EPA opposing the IQA request (Attachment
3), CFRW and other groups pointed out that State scientists disagreed with Chemours’ characterization of
their views and in fact found evidence of higher cancer rates in Eastern North Carolina counties:
The data Chemours cites is merely a tabulation of cancer incidence data in different
North Carolina counties. This tabulation is not an epidemiological study and was not
published in the peer reviewed literature. Moreover, according to NCDHHS itself,
Chemours’ description of the data is simply incorrect. As reported in a recent article in
The Intercept:
NCDHHS did not conclude that rates of liver and other cancers are generally
lower in North Carolina counties with exposures to [GenX] than the rates reported
in the U.S. general population, in the state of North Carolina, or in North Carolina
counties without alleged exposure” to GenX, Catie Armstrong, a spokesperson for
the department, wrote in an email to The Intercept. Armstrong also noted that
while overall cancer rates in the four counties studied were similar, in New
Hanover County rates of testicular cancer were elevated over a 20-year period and
rates of liver cancer were higher over a five-year period. The cancer rates
collected by the health department are descriptive, Armstrong said, and “only a
comprehensive research study can provide information about whether a specific
exposure might be associated with increased rates of cancer.”
23. Chemours also fails to mention a recent publication by North Carolina State University
researchers from the “GenX exposure study,” which is collecting and analyzing data on the presence of
GenX and other PFAS related to the Chemours Fayetteville Works in the blood and drinking water of local
residents.7 In this study, elevated PFAS levels in the blood of residents “were associated with higher levels
of total and non-HDL cholesterol, with associations larger in magnitude among older adults.” Although
this current paper – one of many more to come as part of this study -- does not involve cancer, it provides
direct human epidemiology evidence of the relationships between PFAS exposure in Eastern North
7
Rosen, E. M., Kotlarz, N., Knappe, D.R.U., Lea, C.S., Collier, D.N., Richardson, D.B., Hoppin, J.A.
(2022). Drinking Water–Associated PFAS and Fluoroethers and Lipid Outcomes in the GenX Exposure
Study. Environmental Health Perspectives, 130(9). https://doi.org/10.1289/EHP11033.
10
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24. Further, the National Academies of Science, Engineering, and Medicine (NASEM) was
contracted by CDC, ATSDR, and the National Institute of Environmental Health Sciences (NIEHS) to
produce a report that includes suggestions for updating ATSDR’s Overview of the Science and Guidance
for Clinicians on PFAS. The NASEM panel recommended that exposed people get their blood tested for
PFAS to inform medical decisions. They recommended certain health-based actions depending on the
summed concentration of 7 PFAS (PFOS, PFOA, PFHxS, PFNA, PFDA, PFUnDA, and MeFOSAA) in
blood. The NC GenX Exposure Study tested for these PFAS in the blood samples and these PFAS were
detectable in most study participants in 2020-2021. About 30% of people in the study had summed PFAS
concentrations above 20 ng/mL – the level associated with the highest risk for adverse health effects based
I declare under penalty of perjury that, to the best of my knowledge, the foregoing is true and
correct.
________________________________
Dana Sargent
11
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Attachment 1
Supplemental Declaration of Dana Sargent
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VIA E-MAIL
Re: The Chemours Company FC, LLC (“Chemours”) Plan to Install Granular
Activated Carbon Treatment on Residential Drinking Water Wells
As requested, please find enclosed Chemours’ plan for installing and maintaining
granular activated carbon (“GAC”) treatment units on residential drinking water wells in
proximity of Chemours’ Fayetteville, North Carolina facility (“Fayetteville Works”). Eligible
wells to be included in this program are those wells in primary residential drinking water
service from which either Chemours or the North Carolina Department of Environmental
Quality (“DEQ”) has analyzed samples and detected C3 dimer acid (CASRN 13252-13-6) at
or above the North Carolina Department of Health and Human Services’ provisional health
goal of 0.14 µg/L (140 ppt) (for convenience, hereinafter referred to as “Affected Wells”).
As you are aware, Chemours has been conducting a continuing residential wells
sampling program, in consultation and cooperation with DEQ, to identify any exceedances of
the provisional health goal, and has been providing free bottled water to residents, both while
their sampling results are pending and thereafter if their results are at or above the provisional
health goal. The purpose of the enclosed plan is to move expeditiously to relieve
homeowners of the inconveniences associated with using bottled water by installing proven
technology that will remove C3 dimer acid, thus enabling them to resume using their well
water without any concern for the presence of C3 dimer acid exceeding the health goal.
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extend its sampling investigation in accordance with its ongoing consultations with DEQ; and
our plan going forward also includes further sampling for those wells that to date have tested
below the health goal, but above 100 ppt, for three additional sampling rounds on a quarterly
basis, to verify that they do not constitute Affected Wells.
The enclosed Implementation Plan includes detailed results of the pilot testing
program that Chemours performed to verify that GAC treatment is fully effective for the
purpose required. These systems have proven effective in treating polyfluorinated
compounds (“PFCs”) at other facilities within the United States and in the in-situ pilot testing
conducted near the Fayetteville Works in which the specific PFC of concern, C3 dimer, was
removed. Chemours is confident that the systems are capable of removing C3 dimer acid to
or below the level of detection, which is 2 orders of magnitude lower than the health goal, and
will meet the health goal when put into routine operation and properly maintained. We
believe strongly that no additional pilot tests are necessary before we can and should begin
offering GAC treatment units to every Affected Well owner, so they can be freed of the
constraints or inconveniences of bottled water, about which we have heard expressions of
weariness from residents.
That said, Chemours also has been informed by DEQ that some members of the
community might be skeptical of the efficacy of these units because the in-situ pilot testing
was done on only 1 well, owned by a Chemours employee. We assure DEQ and our
neighbors that the pilot test results are absolutely accurate, representative and reliable. Our
program puts no one at risk (except, conceivably, Chemours): we will continue supplying
bottled water as we have been, until after validation testing at that specific location, the results
of which (certified laboratory analyses of both pre-treatment and post-treatment well water)
will be shared immediately upon receipt with both the resident and DEQ. Chemours is so
confident that these systems will perform excellently that it will undertake the expense of
purchasing, installing and testing the systems with the explicit understanding and agreement
that Chemours will -- at its sole cost and obligation -- remove the systems and return the
Affected Well owner’s property to its pre-installation condition, if any system fails to meet
the objective of C3 dimer acid removal. Further, all units will be maintained and operated by
Chemours on a timetable that insures that new carbon is installed before, under the
circumstances of each owner’s respective well water use, the system might begin to lose its
effectiveness in eliminating exceedances of the health goal.
Chemours plans to commence contacting these affected residents January 22, 2018
and to begin shortly thereafter installing GAC treatment units pursuant to the enclosed Plan at
each location whose owner accepts the unconditional offer. Accordingly, Chemours
respectfully requests that DEQ review and provide its comments, if any, on the enclosed
materials before that date, so that installation of these systems as an alternative to bottled
water is not further delayed for any residents who want them. The Company will continue to
provide bottled water to those owners of Affected Wells who decline the offer or wish more
time to consider it.
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One final matter we wish to address summarily here, in addition to addressing it in the
enclosed Implementation Plan. Questions have been raised about the possibility that other
PFCs might be present at low levels in off-site groundwater drawn from the Affected Wells.
We have, as DEQ knows, conducted analyses for certain other PFCs (i.e., those for which
reliable analytical methods have been established); and the results of those analyses have been
furnished timely to DEQ. That sampling indicates that very few other PFCs that might
arguably be associated with operations from the Chemours facility are found in off-site
groundwater impacted by C3 dimer. As explained in detail in the Implementation Plan, the
levels detected of those other compounds were in the same range (in one case) or lower than
C3 dimer. Further, the post-treatment analyses of those samples confirm that the GAC units
are capable of removing those PFCs as well (down to or below the level of detection under
established, validated analytical methods). Chemours therefore believes that the GAC units
will remedy any other such PFC contamination attributable to plant operations, even in the
absence of any health goal or other standard against which to judge whether the trace levels
found are of potential concern. Nonetheless, our Implementation Plan includes a cooperative
sampling verification program subject to NCDEQ review to confirm GAC units’ effectiveness
in removing these other measurable PFCs, to further validate this beneficial finding.
Thank you.
Sincerely,
Kevin P. Garon
Project Director
Chemours Corporate Remediation Group
Enclosures
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301 Plainfield Road, Suite 350 | Syracuse, New York 13212
P: 315.451.9560 | F: 315.451.9570 | www.parsons.com
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Kevin P. Garon
Chemours Corporate Remediation Group
Carbon Implementation Plan
January 11, 2018
Page 2 of 12
• GAC effectiveness was demonstrated in studies evaluating removal of PFCs from municipal drinking
water in Hoosick Falls, New York and has been successfully applied for removal of PFCs from
residential (e.g., South New Jersey) drinking water supplies and industrial wastewater / groundwater
(e.g., Parlin, New Jersey; Parkersburg, West Virginia).
Evaluation of GAC for C3 Dimer Acid Treatment
In light of GAC treatment’s effectiveness for treating a range of PFCs elsewhere in the United States, Chemours
undertook laboratory and pilot tests of GAC treatment for C3 dimer acid and other PFCs to evaluate the
technology’s effectiveness in treating residential drinking water supplies near the Fayetteville Works and to
determine the rates at which the GAC media is used up. As discussed below and in greater detail in the attached
Technical Memorandum (Attachment 1), these tests confirm that GAC treatment is effective in treating C3 dimer
acid and other PFCs in these water supplies to remove these compounds down to or below their respective levels
of detection, well below the provisional health goal for C3 dimer acid and any reasonably foreseeable
remediation or health goals, should any be established for one or more of these other PFCs in the future.
Chemours installed a North American Aqua Environmental, Inc. WHS-400 GAC adsorption system consisting of
dual carbon contactors at a residence near the Fayetteville Works where untreated well water testing indicated
C3 dimer acid to be present at concentrations averaging approximately 800 ppt. These levels were consistently
among the highest levels regularly detected in the off-site groundwater investigation that Chemours has
undertaken in the vicinity of Fayetteville Works, and within a factor of two of the single highest concentration
measured. The purpose of the installation was to provide an opportunity to verify and troubleshoot application
of GAC for removing C3 dimer acid in residential water systems which represented an elevated influent C3 dimer
acid concentration. The GAC used in this system was Calgon Filtrasorb® 600 GAC (F600 GAC).
To provide a basis of evaluation, Parsons analyzed the effectiveness of F600 GAC for removing C3 dimer acid
from residential well water through performance of bench-scale laboratory carbon adsorption studies, including
(1) isotherm testing, and (2) column testing. Technical details are provided in Attachment 1 of this report.
Testing summaries are presented in this section.
Isotherm Testing. The objective of isotherm testing was to determine the general adsorptive capacity of F600
GAC for removing C3 dimer acid from residential well water. Testing was performed by spiking C3 dimer acid
into a batch of well water and then adding the spiked well water to a series of bottles each containing different
amounts of pulverized and sieved (#325) F600 GAC. After mixing for at least 24 hours, the treated water from
each bottle was filtered and analyzed for the concentration of C3 dimer acid remaining in solution (Ce). These
results were used as follows:
• The “x/m” ratio (mass of C3 dimer acid adsorbed divided by mass of carbon) was calculated for each
bottle.
• The x/m values were plotted against the corresponding Ce values to generate a Freundlich adsorption
isotherm of the form x/m = KfCe1/n, where Kf and 1/n are the Freundlich isotherm parameters.
• The results for Kf and 1/n were used to estimate the adsorption capacity of F600 GAC to treat C3 dimer
acid to or below the provisional State health goal per NCDHHS of 0.14 µg/L (140 ppt).
• The adsorption capacity was used to calculate the rate of GAC utilization under equilibrium conditions
based on the reported C3 dimer acid influent concentration of 0.8 µg/L (800 ppt).
2
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Kevin P. Garon
Chemours Corporate Remediation Group
Carbon Implementation Plan
January 11, 2018
Page 3 of 12
Two tests were performed, each at different spiked C3 dimer acid concentrations. The results of this testing and
calculations are summarized in Table 1.
Table 1. Isotherm Test Results Summary for C3 Dimer Acid Adsorption on Filtrasorb® F600
C3 Dimer Freundlich Model Results F600 Adsorption Capacity
F600 Utilization
Test Acid Spike at Provisional State Health
Kf 1/n At Equilibrium
(mg/L) Goal of 0.14 µg/L
Bench-Scale Column Testing. A bench-scale column test was also performed to capture breakthrough of the C3
dimer acid “wave front” under typical flow conditions to estimate actual GAC utilization as water passes through
a column bed. Two 1-in diameter Pyrex columns were set up in series, including a “short” lead column (35 g
F600 GAC) and “long” lag column (115 g F600 GAC). The GAC was de-aerated by soaking in distilled water,
placing the GAC in the column apparatus (held in place by glass wool), ensuring the GAC properly “seated” in the
columns, and recirculating distilled water overnight to eliminate air bubbles. A batch of well water was spiked
with C3 dimer acid to a final concentration of 123 µg/L and introduced through the columns at a hydraulic
loading rate of 2.07 gpm/ft2. C3 dimer acid samples were collected in column effluent periodically over a 54-
hour period. The results and extrapolation to estimated field GAC utilization are summarized in Table 2.
Table 2. Bench-Scale Column Test Results Summary for C3 Dimer Acid Adsorption on Filtrasorb® F600
and Extrapolation to Estimated Field Performance
Based on extrapolation of laboratory results to field installation, estimated GAC utilization at a nominal 1 gpm
continuous flow under ideal treatment conditions (hydraulic loading rate ≤ 5 gpm/ft2; no short-circuiting) would
be approximately 36 lb. per year. Based on this utilization rate, a carbon unit containing 200 lb. of F600 GAC
would be expected under proper treatment conditions and no short-circuiting to provide over 5 years of service
before breakthrough at the provisional health goal of 0.14 µg/L (140 ppt) while treating water from this location
at an influent C3 dimer acid concentration of 0.8 µg/L (800 ppt).
Field Pilot Study. The residential North American Aqua WHS-400 system installed in the affected area consisted
of two (2) WHS-400 contactors configured in series, each containing 200 lb. of Calgon Carbon Filtrasorb® 600
GAC, and was installed after a pre-existing iron filter. Cumulative flow and periodic sampling for C3 dimer acid
in the influent, lead column effluent, and lag column effluent was performed periodically after installation.
3
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Kevin P. Garon
Chemours Corporate Remediation Group
Carbon Implementation Plan
January 11, 2018
Page 4 of 12
Monitoring under actual water use demand was performed for a period of 5 weeks following installation, followed
by a 5-week period during which a continuous flow of approximately 1 gpm was imposed (for the purposes of
accelerating assessment of possible breakthrough).
An average influent C3 dimer acid concentration of approximately 0.8 µg/L (800 ppt) was measured in the
untreated water collected from the well during the course of the study. Breakthrough from the lead column at
the provisional State health goal of 0.14 µg/L (140 ppt) occurred at approximately 45,000 gallons of flow,
resulting in a GAC utilization rate of 440 lb. per 100,000 gal. The field test demonstrated that an installed GAC
system was capable of removing C3 dimer acid to well below the provisional State health goal and that
verification sampling and regular monitoring would be required to ensure the system is replenished with fresh
carbon before the C3 dimer acid has a chance to breakthrough at or above this goal.
In addition to C3 dimer acid, additional PFCs were tracked during field testing. The list of PFCs and summary of
analyses are presented in Section 6.3 of the carbon column testing Technical Memorandum (Attachment 1). A
majority of the compounds were below detection in influent samples; of the compounds that were measured at
detectable levels by an independent certified analytical laboratory (EPA Method 537 – list of 15 PFCs), the levels
were considerably below that of C3 dimer acid. Internally-measured Table 3 compounds including perfluoroalkyl
ether carboxylic acids (PFECAs) and perfluoroalkyl ether sulfonic acid (PFESA) byproducts indicated a
comparable influent concentration and breakthrough of perfluoro(3,5-dioxahexanoic) acid (PFO2HxA). Overall,
C3 dimer acid may reliably be utilized as a primarily indicator compound for PFCs along with verification sampling
of EPA Method 537 and Table 3 compound lists at a select number of residential GAC installations.
4
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Kevin P. Garon
Chemours Corporate Remediation Group
Carbon Implementation Plan
January 11, 2018
Page 5 of 12
• Chemours will schedule a time convenient to the owner/resident to install the system. Installation will
be performed only by licensed plumbers.
Chemours will begin offering such residences GAC treatment units starting on January 22, 2018. Example letters
to be sent to homeowners/residences are provided in Attachment 4.
Diameter (in.) 10 13
5
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Kevin P. Garon
Chemours Corporate Remediation Group
Carbon Implementation Plan
January 11, 2018
Page 6 of 12
6
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Kevin P. Garon
Chemours Corporate Remediation Group
Carbon Implementation Plan
January 11, 2018
Page 7 of 12
• Sampling will be performed at the Mid sampling point every two weeks for an additional two sampling
events following initial installation for continued troubleshooting;
• Sampling for GAC system performance and breakthrough monitoring will be performed quarterly at the
Mid sampling point assuming verification sampling performed during the troubleshooting period
confirms successful installation and startup of the GAC system.
• This sampling schedule will be repeated each time GAC changeout is performed.
A similar sampling plan (schedule and sample points) will be implemented for WHS-200 system installations,
except that sampling for GAC system performance and breakthrough monitoring will be performed every 1.5
months following the initial troubleshooting period.
In the event that breakthrough of C3 dimer acid at or above the respective state provisional health goal is
detected from the lead column during a given year, more frequent sampling will be instituted at the specific
residence where this occurs. If other PFCs from the EPA Method 537 or Table 3 lists are detected above any
state provisional health goals for those compounds at the select residences during quarterly sampling, then
more frequent sampling and / or sampling at additional residences will be considered.
Samples for C3 dimer acid and EPA Method 537 will be analyzed by Chemours’ contract independent certified
analytical laboratory. Table 3 analyses will be performed internally. Sample results will be submitted to
Chemours’ quality assurance / quality control contractor, who will perform the necessary oversight to ensure
data quality objectives are met consistent with Chemours’ sampling program.
Monitoring for iron removal system performance will rely primarily on residential user reporting of indications of
iron buildup including reduced water pressure at fixtures and detection of orange color in water. Based on
patterns of iron buildup going forward, a regular iron removal system replacement schedule tailored to each
household will be developed to ensure iron buildup does not occur going forward.
Sample Results Reporting
Results of sampling will be reported as follows:
• Results from each sampling event will be provided to homeowners as results are available. Sampling
results from initial performance testing of each system will also be provided contemporaneously to DEQ.
• A report will be prepared and submitted to DEQ each quarter summarizing all sampling results by
residence. The results will be presented in a spreadsheet containing the residential address, date of
GAC system installation, sampling dates, sampling results, and any follow-on activities (e.g., GAC unit
replacement). The quarterly report will also include the results of supplemental sampling of wells which
have exhibited C3 dimer concentrations between 100 and 139 ppt.
GAC Changeout Criteria
7
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Kevin P. Garon
Chemours Corporate Remediation Group
Carbon Implementation Plan
January 11, 2018
Page 8 of 12
Sincerely,
8
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ATTACHMENT 1
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301 Plainfield Road, Suite 350 / Syracuse, New York 13212
P: 315.451.9560 / F: 315.451.9570 / www.parsons.com
TECHNICAL MEMORANDUM
Subject: Chemours Fayetteville – C3 Dimer Acid Bench Carbon Column Study Results
TECHNICAL SUMMARY
Laboratory testing demonstrated the following utilization rates of Calgon Filtrasorb® F600
granular activated carbon (GAC) for removing C3 Dimer Acid from in-situ well water, based on an
influent concentration of 0.8 µg/L (800 ppt) and in reference to the provisional health goal
announced in 2017 by the North Carolina Department of Health and Human Services (“DHHS”) of
0.14 µg/L (140 ppt):
• Utilization rate at equilibrium (isotherm testing): 1.1 – 1.9 lb. / 100,000 gallons.
• Breakthrough point (column testing): 6.8 lb. / 100,000 gallons.
Field testing of F600 GAC in a North American Aqua Environmental, Inc. WHS-400 system
demonstrated removal of C3 dimer acid to non-detect levels; however, the carbon utilization rate
based on breakthrough at 0.14 µg/L from the lead column was approximately 440 lb. per 100,000
gallons treated. Potential factors resulting in higher GAC utilization in the field trial compared to that
predicted from the laboratory column study include the following:
• Flow conditions: Field testing over the 1st half of the field trial proceeded under actual
household demand conditions. Testing over the 2nd half of the field trial proceeded at a
continuous flow rate of 1 gpm; the resulting hydraulic loading rate of 1.1 gpm/ft2 was at the
very low end of the acceptable range for industrial-type systems, and was not representative
of residential service (intermittent high-demand) for which GAC systems such as the WHS-
400 are designed.
• GAC preparation. GAC must undergo thorough wetting / de-aeration, followed by
backwashing to remove fine carbon particulates. The GAC must then be properly “seated” in
the GAC housings.
• Iron fouling. Significant iron was observed in the influent well water to the GAC units. Iron has
the potential to foul GAC and to increase backpressure which can result in short-circuiting.
Factors to optimize performance and reduce breakthroughs include (1) standardized installation,
startup, and operating procedures; (2) C3 dimer acid monitoring protocol for initial troubleshooting
and on-going performance verification, maintenance, and GAC replenishment; and (3) installation
and monitoring of effective iron removal systems suitable for household application.
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Technical Memorandum
January 11, 2018
Page 2
EXECUTIVE SUMMARY
Parsons performed bench-scale carbon column testing of (2,2,3,3-tetrafluoro-2-
(heptafluoropropoxy)propionic acid (C3 dimer acid) in November 2017 to estimate GAC utilization
under actual flow conditions. Bench-scale column testing results were compared to results of field
testing performed by others of a North American Aqua Environmental, Inc. WHS-400 GAC treatment
system installed at a residence in the affected area.
Isotherm Testing
Isotherm testing conducted by Parsons prior to laboratory column studies confirmed Calgon
Filtrasorb® F600 GAC was effective for treating C3 dimer acid in well water from the area of interest.
Isotherm testing was reported in the Technical Memorandum “Chemours Fayetteville – C3 Dimer
Acid Carbon Isotherm Study Results” (Appendix A). Application of the Freundlich isotherm model
resulted in an estimated adsorption capacity of 0.29 – 0.50 mg C3 dimer acid per g GAC at
equilibrium to achieve a target treated concentration of 0.14 µg/L (140 ppt). Based on an influent
concentration of 0.8 µg/L (800 ppt) based on field testing, estimated GAC utilization at equilibrium
of 1.1 – 1.9 lb. / 100,000 gallons water treated was calculated.
Bench Column Testing Procedures
Column testing was performed at Parsons’ Syracuse, NY treatability laboratory using well water
collected from the same residence and at the same point of collection as water used in the isotherm
study. The purpose of column testing was to demonstrate removal of C3 dimer acid and estimate
GAC utilization rates based on breakthrough as water flowed through a bed of GAC. Calgon F600
GAC was used in the column study, as had been used in the isotherm study. 1-in diameter Pyrex
tubing was used to house the carbon beds. Two columns were operated in series including a short
(35 g GAC) lead column and long (115 g GAC) lag column. Distilled water was used to de-aerate the
GAC and eliminate bubbles within the column beds to prevent short-circuiting.
A 40-gallon batch of well water was spiked to an added C3 dimer acid concentration of
123 µg/L. The use of a higher test influent concentration (approximately two orders of magnitude
higher than the average well water influent concentration of0.8 µg/L measured during field testing)
was consistent with standard GAC column testing methodology to compress the duration of the test
while providing data scalable to full-scale installations. Influent was pumped from the spiked batch
through the beds using a peristaltic pump at a flow rate of 42.8 mL/min, providing a hydraulic
loading rate of 2.07 gpm/ft2. Effluent from both the lead and lag columns was collected at discrete
time intervals over a 54-hour period and analyzed for C3 dimer acid by TestAmerica, Arvada, CO.
Bench Column Testing Results
Breakthrough was defined for this study at the provisional State health goal of 0.14 µg/L.
Breakthrough of C3 dimer acid occurred at approximately 46 hours from the lag column, or after 493
lead + lag Empty Bed Contact Volumes (EBCVs) had passed. Scaled to an influent concentration of
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Technical Memorandum
January 11, 2018
Page 3
0.80 µg/L, and based on an EBCV of 5.2 ft3 for the GAC in a single WHS-400 contactor, the
estimated GAC utilization was 6.8 lb. per 100,000 gallons water treated.
Field Results Comparison
Based on the bench column study results and assuming proper installation, startup and
operation, each WHS-400 unit filled with 200 lbs. of F600 GAC would be expected to provide an
extended period of C3 dimer acid adsorption capacity at the influent concentrations reported to
Parsons at typical residential water use estimates. Parsons recommends the installation of two (2)
units in series would be a minimum design standard, and regular monitoring to detect for C3 dimer
acid breakthrough. Parsons also recommends carbon replacement should be performed when
breakthrough is detected at a pre-selected action level (e.g., one-half the provisional health goal)
from the lead column.
Field testing of an installed WHS-400 system containing F600 GAC was performed over a 10-
week period from September to November 2017. Over this stretch, regular flow monitoring and
analysis of C3 dimer acid and other polyfluorinated compounds (PFCs) were performed. The 10-
week evaluation included 5 weeks of actual water demand followed by 5 weeks during which a
continuous, increased flow rate of 1 gpm was imposed to accelerate the test time table while
maintaining a hydraulic loading rate reflective (on the low end) typical of GAC adsorption systems.
The field test demonstrated the ability of the installed system to remove C3 dimer acid to below
detection. Breakthrough at the provisional health goal (0.14 µg/L) from the lead column occurred
after approximately 45,000 gallons had been treated, or an effective utilization rate of approximately
440 lb. GAC per 100,000 gallons treated. An examination into the potential design and operability
factors contributing to the departure between expected versus actual GAC utilization in the installed
system highlighted the importance of the following:
• Flow conditions.
o Field testing over the 1st half of the field trial proceeded under actual household
demand conditions. Testing over the 2nd half of the field trial proceeded at a
continuous flow rate of 1 gpm; the resulting hydraulic loading rate of 1.1 gpm/ft2
was at the very low end of the acceptable range for industrial-type systems, and
was not representative of residential service (intermittent high-demand) for
which GAC systems such as the WHS-400 are designed. During demand, the
hydraulic loading rate would be closer to typically recommended.
o Low hydraulic loading rates can result in short-circuiting.
• Proper GAC preparation during installation and GAC replenishment to prevent short-
circuiting, including:
o Sufficient soaking time to de-aerate the GAC;
o Backwashing to remove fine carbon particulates from the bed;
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Technical Memorandum
January 11, 2018
Page 4
o Prevention of seepage out of carbon beds which can result in preferential flow
channels.
• Systematic monitoring of C3 dimer acid following installation and startup including:
o Short-term troubleshooting monitoring (e.g., biweekly); and
o Long-term performance monitoring (e.g., quarterly) once stable consistent
performance has been established.
• Removal of iron ahead of the GAC units, to:
o Prevent possible coating of GAC granules which can reduce the amount of
carbon available for adsorption; and
o Prevent backpressure buildup in the GAC units which can potentially result in
short-circuiting.
Field testing also confirmed that C3 dimer acid may justifiably serve as the governing indicator
compounds driving GAC treatment, monitoring, and maintenance requirements. Additionally,
sampling for full EPA Method 537 + PFECA/PFESA scans is recommended in a select number of
residences during each sampling event (See Section 6.3).
Recommendations
Based on the findings of the carbon column testing and comparison to field results, the
following strategy for installation and startup, monitoring, and carbon replacement is recommended
to maximize protection of residents from exposure to PFCs in their domestic water supply, consistent
with feasibility of implementation that affords the desired drinking water protection:
• Place a minimum of two (2) WHS-400 contactors in series at each installation.
• Ensure units are installed by properly licensed tradespeople, in a manner which
prevents backflow / seepage from the columns when water is not in demand.
• Ensure the GAC is properly de-aerated upon installation by soaking for at least two
hours, and backwashing the carbon to remove fine carbon particulates.
• Select a Maintenance Concentration of one-half the health advisory standard which, if
detected in the effluent from the lead column, triggers:
o Replacement of lead column with a fresh column;
o Movement of the lag unit to the lead position; and:
o Placement of the fresh column to the lag position.
• Ensure systems are installed in a manner which prevent backflow or seepage out of the
carbon columns.
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• Monitor for C3 dimer acid as follows following initial installation and startup:
o Effluent from both the lead and lag carbon units after two weeks;
o Continued sampling every two weeks of effluent from the lead column for a
suitable period (e.g., 2 months);
o A reduced frequency of performance monitoring (e.g., quarterly) may be
warranted pending development of a body of data indicating when breakthrough
from the lead column occurs and allowing for continuous improvement in
installation and operational procedures.
• Monitor for C3 dimer acid as follows following carbon replenishment (after breakthrough
occurs):
o Effluent from both the lead and lag carbon after two weeks for troubleshooting;
o Effluent from the lead column after two more weeks for troubleshooting;
o Resumption of performance monitoring schedule (e.g., quarterly) as warranted
from results from post-carbon replenishment troubleshooting sampling.
• Monitor for EPA Method 537 and PFECA/PFESA compound lists at a select number of
residential GAC installations alongside C3 dimer acid during each sampling event
(troubleshooting and performance / breakthrough monitoring).
• Install and monitor a reliable iron removal system upstream of GAC adsorption to
prevent GAC fouling and reduce backpressure which may increase the potential for
short-circuiting within the GAC columns.
o Simple field iron test kits (e.g., HACH) can facilitate field monitoring for iron
concentrations. Alternatively, the presence of reduced flow at household
fixtures may signal iron buildup in the GAC units.
COLUMN STUDY
1.0 INTRODUCTION
Parsons performed isotherm testing in October 2017 to determine the general adsorptive
capacity of Calgon Filtrasorb F600 GAC for C3 dimer acid compound in native groundwater.
Milestone concentrations reported to Parsons included an influent concentration of 0.8 µg/L, a
provisional State health advisory concentration of 0.14 µg/L, and a method detection limit for C3
dimer acid analysis of 0.010 µg/L. A nominal 1 gpm continuous flow rate was used for GAC
utilization calculations.
The isotherm study examined the C3 dimer acid specifically. Other characteristics of the well
water which may have affected GAC adsorption performance of C3 dimer acid (i.e., chemical
properties; other PFCs potentially present) were implicitly captured since well water from a residence
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near Chemours’ Fayetteville, North Carolina facility (“Fayetteville Works”) was sourced for the study.
The results of the study were reported in the technical memorandum “Chemours Fayetteville – C3
Dimer Acid Carbon Isotherm Study Results” (Appendix 1). A summary of the results is presented in
Table 1-1.
Table 1-1. Isotherm Test Results Summary for C3 Dimer Acid Adsorption on Filtrasorb® F600
C3 Dimer Freundlich Model Results
F600 Adsorption Capacity F600 Utilization
Test Acid Spike
Kf 1/n at Target Treated Ce At Equilibrium(1)
(mg/L)
A 0.25 9.9 0.34 0.50 mg / g GAC 5.8 lb. /year
B 2.0 11.6 0.42 0.29 mg / g GAC 9.9 lb. /year
(1)Based on 1 gpm continuous flow; equivalent to 1.1 lb. /100,000 gal (Test A) and 1.9 lb. /100,000 gal
(Test B).
The calculated GAC utilization at equilibrium from the isotherm study would represent ideal
contact conditions between water and the F600 GAC. However, by definition, these column study
results do not necessarily demonstrate actual levels of adsorption or determination of breakthrough
of the C3 dimer acid “wave front” under actual flow conditions.
2.0 COLUMN STUDY OBJECTIVES
The objectives of the bench-scale column study were to:
• Confirm removal of C3 dimer acid (2,2,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid)
from native groundwater during flow through a bed of Calgon Filtrasorb® F600 GAC.
• Determine when breakthrough of C3 dimer acid in a bed of F600 GAC would be expected, to
assist with GAC contactor sizing and GAC monitoring / replacement frequency.
3.0 RAW WATER SAMPLING
Test water for the C3 dimer acid isotherm study was collected at the same point of collection as
the residential well water used in the isotherm study. 40-gallons of test water was collected in
collapsible plastic carboys and shipped overnight to Parsons’ Treatability Laboratory in Syracuse, NY.
4.0 TEST PROCEDURES
4.1 General GAC Column Study Methodology
Groundwater spiked with an appropriate concentration of target compound is pumped through
two GAC test beds installed in series. Each test bed is contained within a circular Plexiglass column,
held in place with glass wool. An appropriate hydraulic loading rate is applied. Samples for the
target compound are collected at discrete time intervals at the outlet of each column to observe
progression of the target compound “wave front” and as such capture breakthrough. The influent
concentration, flow rate, and timing of breakthrough are scaled to support design including contactor
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sizing and configuration, and anticipated GAC utilization rates thereby informing an appropriate
schedule for monitoring and GAC replacement to prevent breakthrough.
4.2 Specific Test Procedures
Two (2) individual columns fabricated from 1-in ID Plexiglass were arranged in series, including
a short-bed column containing 35 g of F600 GAC and a long-bed column containing 115 g F600
GAC. The GAC for each column was pre-rinsed with distilled water to remove fugitive carbon
particulates and saturate the carbon pores, then added wet to the column tubes. The carbon was
held in place with glass wool and rubber stoppers penetrated with tubing connections.
Interconnecting tubing was composed of flexible plastic tubing. A peristaltic pump was used to pump
column influent from a reservoir through the columns. Flow proceeded from the bottom to the top of
each column. A tee in the line between the lead and lag columns allowed lead column effluent
samples to be collected. Lag column effluent samples were collected from tubing leading from the
exit stopper of the lag column. Figure 4-1 shows the column study in operation.
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An influent concentration of 123 ± 10 µg/L was measured across the duration of the study.
Breakthrough from the lead (short) column occurred in less than one hour and is considered an
artifact of testing based on the elevated influent test concentration; breakthrough from the lag
column at the provisional State health goal of 0.14 µg/L occurred at 46.4 hours. Breakthrough from
the lag column is shown in Figure 5-1.
0.50
0.40
0.35
Concentration (ug/L)
0.30
0.25
0.20
0.15
0.10
0.05
0.00
0 10 20 30 40 50 60
Elapsed Time (Hrs)
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been treated. Based on this breakthrough result, GAC utilization was approximately 440 lb. per
100,000 gallons treated, compared to 7.7 lb. per 100,000 gallons predicted from the laboratory
column study results.
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The laboratory study represents highly-controlled conditions regarding setup and operation, and
regular observation (e.g., for short-circuiting) is greatly enhanced by the use of clear Pyrex tubing.
However, the laboratory study also used water from the same residence such that any effects due to
characteristics of the well water would have been captured in the laboratory study and as such would
not explain the discrepancy.
6.2 Potential Factors Contributing to Departure Between Field and Laboratory Results
Parsons examined design and operability factors which may have resulted in the observed field
performance relative to estimates predicted from column testing.
Design. The WHS-400 units are specified by the North American Aqua Environmental, Inc. as follows:
• Diameter: 13-in Cross-sectional area = 0.92 ft2
• GAC Mass: 200 lb.
• Bed Depth: 50 in
• Recommended flow rate: 4 – 7 gpm
The units are designed to accommodate intermittent high-flow demand typical of residential water
use. The GAC units operate under the normal water supply pressure. Flow enters through the top of
each unit and down through the carbon bed in each column. The flow is distributed axially across
the column at the top as it flows into the columns. Water proceeds down through the GAC bed and
through a basket-like feature at the bottom of the column, from which the water is transferred
through a transfer line up through and out of the column. As such, the column represents plug-type
flow through the column under pressure when a demand is placed.
Flow during the first 5-week period of field testing was under actual demand conditions. However, a
continuous flow of 1 gpm was sustained during the 2nd 5-week period. Based on the cross-sectional
area of the carbon units, the hydraulic loading rate during this period was 1.1 gpm/ft2. This is on the
very low end of hydraulic flow rates (1 – 5 gpm/ft2) typically applied in industrial systems and which
the laboratory column study simulated. The relatively low hydraulic loading rate and maintenance of
continuous flow through a system designed primarily for intermittent, high demand (during which
times the hydraulic loading rate would be more favorable) may have factored into higher utilization
due to short-circuiting.
Operability.
Other potential mitigating factors which should be considered going forward in the placement and
operation of installed GAC contactors for this application may include the following:
• Ensure GAC is properly wetted / de-aerated, and ensure the GAC properly “seats” within the
carbon units. This is vital to prevent short-circuiting.
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• Backwash the columns to removal fine carbon particulates. Backwashing may also help seat
the GAC properly before normal flow is applied.
• Install a reliable iron removal system upstream of the GAC units, and regularly monitor the
iron concentration in the effluent from the iron removal system. Iron carryover into the GAC
units has the potential to reduce GAC performance (due to coating) and increase
backpressure, which could potentially result in short-circuiting through the GAC units. In the
event iron measurements are not feasible, iron buildup may be ascertained through a
reduction in flow at household fixtures. Based on the frequency at which reduced flow is
detected, a regular iron system maintenance / replacement schedule applicable to each
household could potentially be developed.
A Standard Operating Procedure (SOP) outlining specific steps during installation and carbon
changeout may alleviate any operational shortcomings. Frequent up-front sampling is recommended
which can help troubleshoot and refine operational procedures, which may improve carbon
utilization and extend periods between changeouts.
6.3 Other Polyfluorinated Compounds (PFCs)
6.3.1 EPA Method 537 List of 15 Compounds
EPA Method 537 scans were performed by an independent certified analytical laboratory for
samples collected from the Pre, Mid, and Post sample points on 11/6/17 and 11/22/17. These
dates correspond to approximately 6.5 and 9 weeks, respectively, after the field trial commenced, or
approximately 1.5 and 4 weeks after the initiation of a continuous 1 gpm flow stream through the
system. Duplicate sampling and analysis were performed at the Post sampling point on 11/22/17.
The analyzed compounds and corresponding detection limits are listed in Table 6-1.
Table 6-1. EPA Method 537 Compound List and Detection Limits
Method
Compound Abbreviation Reporting Limit
(µg/L)
N-ethyl perfluorooctane sulfonamidoacetic acid NEtFOSAA 0.020
N-methyl perfluorooctane sulfonamidoacetic
NMeFOSAA 0.020
acid
Perfluorobutanesulfonic acid PFBS 0.0020
Perfluorodecanoic acid PFDA 0.0020
Perfluorododecanoic acid PFDoA 0.0020
Perfluoroheptanoic acid PFHpA 0.0020
Perfluorohexanesulfonic acid PFHxS 0.0020
Perfluorohexanoic acid PFHxA 0.0020
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The following provides a summary of results from the sampling and analysis for the EPA Method 537
list of compounds.
• The following compounds were reported above their respective Method Reporting Limit in Pre
(influent) samples:
o PFHpA: 0.0028 – 0.0029 µg/L (2.8 – 2.9 ppt)
o PFHxA: 0.0040 – 0.0041 µg/L (4.0 – 4.1 ppt)
o PFPeA: 0.013 µg/L (13 ppt)
o PFOA: 0.011 – 0.015 µg/L (11 – 15 ppt)
• During the 11/6/17 sampling, all 15 compounds in Table 6-1 were reported below their
respective Method Reporting Limit at the Mid and Post sample points.
• During the 11/22/17 sampling, the only compound with values reported above its Method
Reporting Limit in Mid and Post samples was PFPeA, as follows:
o Mid sampling point: 0.010 µg/L (10 ppt)
o Post sampling point: 0.0034 µg/L (3.4 ppt), respectively.
o Post sampling point (duplicate): 0.0035 µg/L (3.5 ppt).
• Although PFOS was not detected in the Mid or Post samples on 11/22/17, the duplicate
scan indicated a reported value of 0.024 µg/L (24 ppt). This appears to be inconsistent with
the absence of PFOS in the Pre (influent) samples collected both 11/6/17 and 11/22/17.
• No other compounds from Table 5-1 were detected in any of the samples collected during
these two sampling events.
6.3.2 Table 3 Compounds
Analyses for Table 3 compounds including perfluoroether alkyl carbonic acids (PFECAs) and
perfluoroether alkyl sulfonic acids (PFESAs) were performed internally to Chemours for samples
collected from the Pre, Mid, and Post sample points on 10/12/17, 11/6/17 and 11/22/17. The
analyzed compounds and corresponding detection limits are listed in Table 6-2.
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Table 6-2. PFECA and PFESA Compound List and Detection Limits
Limit of
Compound Abbreviation Quantitation
(µg/L)
Perfluoro-2-methoxyacetic acid PFMOAA 0.21
Perfluoroether alkyl carbonic acid – A PFECA-A 0.20
Perfluoroether alkyl carbonic acid – G PFECA-G 0.20
Perfluoroether alkyl carbonic acid – F PFECA-F 0.20
Perfluoro(3,5-dioxahexanoic) acid PFO2HxA 0.20
Perfluoro(3,5,7-trioxaoctanoic) acid PFO3OA 0.20
Perfluoro(3,5,7,9-tetraoxadecanoic) acid PFO4OA 0.20
C7HF1307 C7HF13O7 0.20
PFESA Byproduct 1 PFESA_Byproduct 1 0.20
PFESA Byproduct 2 PFESA Byproduct 2 0.20
The following provides a summary of results from the sampling and analysis for the Table 3
compounds.
• PFO2HxA was measured in influent (Pre) samples above its Limit of Quantitation during all
three sampling events, at a range of 0.86 – 0.94 µg/L (860 – 940 ppt).
o Concentrations of PFO2HxA in Mid samples collected on 10/12/17 and 11/6/17
were below the LOQ; the Mid sample collected on 11/22/17 exhibited a
concentration of 0.54 µg/L (540 ppt) suggesting breakthrough at the Lead column.
o Concentration of PFO2HxA in Post samples were below the LOQ for all sampling
events, demonstrating this compound did not break through the Lag column at or
above the LOQ.
• PFECA-F was tentatively measured above its Limit of Quantitation in influent (Pre) samples
collected 10/12/17 and 11/6/17 at 0.36 µg/L (360 ppt), and Mid Sample collected
11/6/17 with a reported concentration of 0.66 µg/L (660 ppt) almost twice the influent
sample concentration.
o Co-elution of an interfering or structurally-similar isomer may have limited ability to
quantify this compound.
o The reported concentration in Post samples was below the Limit of Quantitation from
all sampling events. Subsequent sampling on 11/22/17 resulted in reported
concentrations below the Limit of Quantitation for the Pre and Mid samples as well.
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• PFMOAA was reported in the Mid sample on 11/6/17; however, PFMOAA was below the Limit
of Quantitation in influent (Pre) samples during all three sampling events.
In summary, the concentration of C3 dimer acid was comparable to PFO2HxA, which broke through
along a similar timeline from the Lead column as C3 dimer acid. Otherwise, C3 dimer acid was the
predominant compound relative to all other EPA Method 537 and PFECA/PFESA compounds
analyzed. Based on these observed results, the following conclusions have been developed:
• C3 dimer acid may satisfactorily serve as a governing indicator compound driving GAC
treatment, monitoring, and maintenance requirements. Additionally, sampling for full EPA
Method 537 + PFECA/PFESA scans is recommended in a select number of residences during
each sampling event.
• In the event PFO2HxA or other PFECA/PFESA compounds demonstrate breakthrough prior to
C3 dimer acid, then utilization of C3 dimer acid as the governing indicator may need to be
reassessed.
7.0 CONCLUSIONS AND RECOMMENDATIONS
The following conclusions were developed based on the results of the column study:
• C3 dimer acid in the groundwater matrix is adsorbed effectively onto Calgon Filtrasorb® F600
GAC under flow conditions at typical hydraulic loading rates for carbon contactors.
• Estimated F600 GAC utilization assuming an influent C3 dimer acid concentration of
0.8 µg/L and a provisional health goal of 0.14 µg/L is approximately 6.8 lb. per 100,000
gallons treated.
• A significantly accelerated time to breakthrough was observed during field testing compared
to laboratory testing, with carbon utilization of approximately 440 lb. per 100,000 gallons
treated observed.
• Field analysis of other PFCs demonstrate removal of all other compounds by GAC and
justifies utilization of C3 dimer acid as a governing indicator compound driving GAC
treatment, monitoring, and maintenance requirements along with EPA Method 537 and
PFECA/PFESA compounds analyzed in a select number of residences during each sampling
event.
Parsons has developed the following conclusions and recommendations based on these
conclusions plus associated observations from the lab and field.
• Place a minimum of two (2) WHS-400 contactors in series at each installation.
• Ensure units are installed by properly licensed tradespeople, in a manner which
prevents backflow / seepage from the columns when water is not in demand.
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• Ensure the GAC is properly de-aerated upon installation by soaking for at least two
hours, and backwashing the carbon to remove fine carbon particulates.
• Select a Maintenance Concentration of one-half the health advisory standard which, if
detected in the effluent from the lead column, triggers:
o Replacement of lead column with a fresh column;
o Movement of the lag unit to the lead position; and:
o Placement of the fresh column to the lag position.
• Ensure systems are installed in a manner which prevent backflow or seepage out of the
carbon columns.
• Monitor for C3 dimer acid as follows following initial installation and startup:
o Effluent from both the lead and lag carbon units after two weeks;
o Continued sampling every two weeks of effluent from the lead column for a
suitable period (e.g., 2 months); and
o A reduced frequency of performance monitoring (e.g., quarterly) may be
warranted pending development of a body of data indicating when breakthrough
from the lead column occurs and allowing for continuous improvement in
installation and operational procedures.
• Monitor for C3 dimer acid as follows following carbon replenishment (after breakthrough
occurs):
o Effluent from both the lead and lag carbon after two weeks for troubleshooting;
o Effluent from the lead column after two more weeks for troubleshooting; and
o Resumption of performance monitoring schedule (e.g., quarterly) as warranted
from results from post-carbon replenishment troubleshooting sampling.
• Monitor for EPA Method 537 and PFECA/PFESA compound lists at a select number of
residential GAC installations alongside C3 dimer acid during each sampling event
(troubleshooting and performance / breakthrough monitoring).
• Install and monitor a reliable iron removal system upstream of GAC adsorption to
prevent GAC fouling and reduce backpressure which may increase the potential for
short-circuiting within the GAC columns.
o Simple field iron test kits (e.g., HACH) can facilitate field monitoring for iron
concentrations. Alternatively, the presence of reduced flow at household
fixtures may signal iron buildup in the GAC units.
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APPENDIX A
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301 Plainfield Road, Suite 350 / Syracuse, New York 13212
P: 315.451.9560 / F: 315.451.9570 / www.parsons.com
TECHNICAL MEMORANDUM
EXECUTIVE SUMMARY
Parsons performed isotherm testing in October 2017 to ascertain the general adsorptive
capacity of Calgon Filtrasorb® F600 GAC for C3 dimer acid compound in native groundwater matrix.
Isotherm testing was performed at Parsons’ Syracuse, NY treatability laboratory.
Procedures
Two isotherm studies were set up, at the target spiked C3 dimer acid concentrations indicated:
• Test A: 0.25 mg/L
• Test B: 2.0 mg/L.
Each study included seven (7) 1-quart wide-mouth amber glass test bottles containing
pulverized, sieved (#325), and dried Filtrasorb® F600 carbon ranging from 0.05 – 40 g, plus an
undosed control. Spiking was performed by preparing a 1 mg/mL spiking solution using GX 903
(product containing C3 dimer acid, provided by Chemours Fayetteville Works), then adding the
appropriate volume of spiking solution to an 8-liter batch of site groundwater for each test. Spiked
groundwater was added to each isotherm test bottle, allowing some room for mixing. Test bottles
were weighed both empty and filled to allow determination of actual experimental GAC doses. Bottles
were agitated, placed on a rotary shaker table, and mixed for 24-hours.
After mixing, the test bottles were allowed to settle. The settled decant was filtered using a
glass syringe through 1 µm pore size syringe filters into analytical sample containers (2 x 250 HDPE
per test bottle). Test samples were submitted to TestAmerica, Arvada, CO for C3 dimer acid analysis.
Results
The Freundlich adsorption isotherm model x/m = KfCe1/n, where x/m = adsorption capacity at a
given equilibrium concentration (Ce), was used to describe the data obtained in each test. Specific
adsorption performance (x/m) was calculated for each test bottle and plotted versus the
corresponding equilibrium concentration measured by TestAmerica, providing for determination of
the Freundlich parameters Kf and 1/n. The adsorption capacity of F600 for C3 dimer acid was then
calculated for a target treated concentration (Ce) equal to the state provisional health goal of
0.14 ug/L, using the calculated Freundlich parameters. The results are presented in Table E-1. The
calculated capacity between tests showed generally good agreement (within a factor of 2).
Technical Memorandum
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Table E-1. Isotherm Test Results for C3 Dimer Acid Adsorption on Filtrasorb® F600
F600 Adsorption Capacity
Test Kf 1/n
at Target Treated Ce(1)
A 9.9 0.34 0.50 mg / g GAC
B 11.6 0.42 0.29 mg / g GAC
(1) 0.14 µg/L
Based on these results, the resulting amount of GAC which would be required assuming an
influent C3 dimer acid concentration of 0.8 µg/L would be approximately 1.1 – 1.9 lb per 100,000
gallons treated. For comparison, rough estimated usage for benzene would be at the high end of this
range and toluene at the low end based on select studies performed by Parsons for other
applications (in which considerable competitive sorption was present).
The reported adsorption capacities do not capture the wave front through the GAC, so the actual
GAC required may be significantly higher. This can be optimized through proper column design (e.g.,
two columns in series to increase GAC utilization) and periodic monitoring from after both the lead
and lag beds to ensure carbon is replaced before breakthrough from the lag bed can occur.
1.0 STUDY OBJECTIVE
The objective for this study was to determine the general adsorptive capacity of Calgon
Filtrasorb F600 GAC for C3 dimer acid compound in native groundwater matrix. The influent
concentration based on residential field testing was approximately 0.8 µg/L. A target treated
concentration of 0.14 µg/L was selected based on the state provisional health goal per North
Carolina Department of Health and Human Services (NCDHHS). The analytical limit for C3 dimer
acid was 0.010 µg/L.
2.0 RAW WATER SAMPLING
Test water for the C3 dimer acid isotherm study was collected downstream from an existing pre-
filtration system at a residence in the area of interest. 5-gallons of test water was collected in
individual one-gallon plastic bottles and shipped overnight to Parsons’ Treatability Laboratory in
Syracuse, NY.
3.0 TEST PROCEDURES
3.1 General GAC Adsorption Isotherm Methodology
Standard GAC adsorption protocol was used. The isotherm study was conducted by adding
different amounts of pulverized and sieved GAC to a series of identical test samples containing
groundwater spiked to an appropriate concentration with target compound. The concentration of
target compound remaining in solution (equilibrium concentration, Ce) at each GAC dose following a
period of mixing (e.g., 24-hours) was measured. The amount of target compound adsorbed (x) was
calculated at each dose (m); x/m was then calculated at each dose and plotted versus the
corresponding Ce values to generate the Freundlich adsorption isotherm. Performance of the study
Technical Memorandum
January 11, 2018
Page 3
using residential well water accounted for matrix background effects that may have affected
adsorption performance (versus performance in pure water).
3.2 Specific Test Procedures
Two individual tests were performed. For each test, an 8-liter batch of site groundwater was
spiked using GX 903 (product containing C3 dimer acid compound, provided by Chemours
Fayetteville Works) to the following target spiked concentrations:
• Test A: 0.25 mg/L (250 µg/L)
• Test B: 2.0 mg/L (2,000 µg/L)
These target concentrations were on the order of 250 and 2,000-fold higher than the influent
concentration reported to Parsons, to provide sufficient “relief” for measuring adsorption
performance.
A spiking solution (1 mg/mL) was prepared to facilitate spiking of batch groundwater. The
1 mg/mL spiking solution was prepared by diluting GX 903 at 1.539 mL per liter based on measured
GX 903 product density of 1,625 mg/mL and 40% of GX 903 product as C3 dimer acid as reported
to Parsons. Spiking of the test batches was then performed by adding the 1 mg/mL spiking solution
at the rate of 2 mL and 16 mL per 8L test batch for Tests A and B, respectively.
The spiked groundwater water was added to a series of eight (8) clean 1-quart wide-mouth
amber glass bottles each containing a different mass of pulverized, sieved (325 mesh), and dried
(105ºC) Filtrasorb 600 GAC, including a control bottle containing no GAC to account for losses no
attributable to GAC adsorption. The target GAC doses ranged from 0.05 – 40 g/L. The bottles were
weighed (1) empty and (2) after adding GAC and test water to determine exact test volumes and
thereby calculate actual experimental GAC test doses. The bottles were capped and vigorously
shaken for one minute, then placed on a table-top rotary mixer for at 24 hours.
After mixing, the bottles were removed from the shaker and allowed to settle for at least one
hour. Treated water from each test bottle (including control) was collected using a glass syringe
fitted with 1 µm pore size syringe filters to remove residual pulverized GAC from suspension, and
transferred into unpreserved HDPE sample bottles (2 x 250 mL for each test bottle). The filtered
samples were submitted through the Syracuse, NY TestAmerica service center for analysis at the
Arvada, Colorado TestAmerica facility. Samples from Test A were also collected and analyzed for
chemical oxygen demand (COD) by Parsons using a HACH test kit to assess the degree of potential
interference (competitive adsorption) attributable to background organic content.
3.3 Data Evaluation
The Freundlich model was used to interpret isotherm data upon receipt of equilibrium concentration
data from TestAmerica. The Freundlich model relates the equilibrium concentration of the adsorbate
(target compound) to the mass of adsorbate that is adsorbed to the carbon as follows:
x
= K f C e1 / n Equation 1
m
Technical Memorandum
January 11, 2018
Page 4
x 1
Log = LogK f + LogC e Equation 2
m n
Equation 2 is in the form of a linear equation y = mx +b, with y = log(x/m), x = LogCe, m (slope) =
1/n, and b (y-intercept) = logKf .
For each applied absorbent dose, the x/m ratio was calculated as follows:
x V (C 0 − C e )
= Equation 3
m M
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Technical Memorandum
January 11, 2018
Page 5
Table 5-1. C3 Dimer Acid GAC Isotherm Test Data and Calculations
Test A
Test B
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Technical Memorandum
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Page 6
6.0
4.0
3.0
2.0
1.0
Test A
0.0
0.00 0.02 0.04 0.06 0.08 0.10 0.12 0.14 0.16
Ce : Equilbrium Concentration (mg/L)
10.0 y = 11.619x0.4152
8.0
6.0
4.0
2.0
Test B
0.0
0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90
Ce : Equilibrium Concentration (mg/L)
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Technical Memorandum
January 11, 2018
Page 7
The isotherm plots show x/m (amount compound adsorbed per mass of GAC) on the Y-axis, and
equilibrium concentration Ce (akin to effluent concentration) on the X-axis. The plots overall indicate
that x/m increases with Ce. Overall, the data obtained showed good agreement with Freundlich
isotherm modeling, providing high confidence in the test results as being indicative of the adsorptive
nature of C3 dimer acid on Filtrasorb F600 GAC.
The adsorption capacity of F600 for C3 dimer acid was then calculated for a target treated
concentration (Ce) of 0.14 ug/L based on the calculated Freundlich parameters from the isotherm
study. The results including the calculated Freundlich parameters and associated adsorption
capacities are presented in Table 5-2.
Table 5-2. Isotherm Test Results for C3 Dimer Acid Adsorption on Filtrasorb® F600
F600 Adsorption Capacity
Test Kf 1/n
at Target Treated Ce(1)
A 9.9 0.34 0.50 mg / g GAC
B 11.6 0.42 0.29 mg / g GAC
(1) 0.14 µg/L
The calculated adsorption capacities between tests showed generally good agreement.
4.2 GAC Utilization at Equilibrium
Estimated GAC utilization was calculated assuming the following inputs:
• Influent C3 dimer Acid concentration (C0): 0.8 µg/L
• Treated C3 dimer acid concentration (Ce): 0.14 µg/L.
The estimated utilization (lb /100,000 gallons) was calculated as follows:
• The total mass of C3 dimer acid adsorbed per year (mg) = V * (C0 – Ce), where V =
total volume (liters) = 100,000 gallons (to obtain lb per 100,000 gal treated).
• Carbon utilization was calculated by dividing the total mass of C3 dimer acid
adsorbed (mg) by the adsorption capacity (mg/g) at the target treated concentration,
and converting g GAC to lb GAC.
Based on the adsorption capacities reported in Table 5-2 and estimated influent concentration, the
estimated F600 GAC utilization would be approximately 1.1 – 1.9 lb/100,000 gal. For comparison,
rough estimated usage for benzene would be at the high end of this range and toluene at the low
end based on select studies performed by Parsons for other applications (in which considerable
competitive sorption was present).
The reported adsorption capacities and associated utilization estimates do not capture the
wavefront of C3 dimer acid through the GAC, where the actual GAC required may be significantly
higher. This can be optimized through proper column design (e.g., two columns in series to increase
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Technical Memorandum
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Page 8
GAC utilization) and periodic monitoring from after both the lead and lag beds to ensure carbon is
replaced before breakthrough from the lag bed can occur.
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ATTACHMENT 2
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Owner Mailing
Address_______________________________________________________________________________
What are the pipe sizes and materials for the interior plumbing? __________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
What is the type and horsepower of the well pump? ____________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
How deep is the well? ____________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
What is the well’s depth to the water table? __________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
What is the approximate location of the well? ________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Where is the existing pressure tank located? __________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
What is the existing water pressure in the house (if known from pressure tank setting)?
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Does the house have a basement? ___________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Is the basement fully or partially finished? ___________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Is the home a single- or two-story structure? __________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
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Does the resident live in this house all year round? ____________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
If they are seasonal residents, is the home heated throughout the winter? ___________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
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ATTACHMENT 3
O&M AGREEMENT
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Condition 1. Chemours will provide at its cost all construction, labor and materials necessary
to install the GAC Treatment System and connect it to the water supply line running from the
Property’s source water to the primary living space on the Property.
Condition 2. Chemours will provide at its cost all labor and materials necessary to restore any
damage to improvements on the Property that result from Chemours’ work installing the GAC
Treatment System and connecting it to the water supply line. Restoration shall consist of
returning all improvements on the Property damaged by Chemours to as near as possible the
condition existing on the date that installation and connection activities begin. The Owner(s)
agree that in the case of grass that is damaged as part of the construction work, reseeding of
the damaged area is acceptable.
Condition 3. Chemours will pay for all operation and maintenance of the GAC Treatment
System, including timely replacement of the carbon filtering medium, based on quarterly
sampling and analysis results. All operation, maintenance and filter replacement will be
performed by Chemours’ designated contractor(s).
Chemours will provide for operation and maintenance of the GAC Treatment System until (a)
Chemours demonstrates to the satisfaction of the North Carolina Department of Environmental
Quality (“DEQ”) that the water system’s source water prior to treatment contains less than 0.14
ug/L of HFPO-DA in drinking water for four consecutive quarters; or (b) Chemours provides an
alternative means for providing to the Property drinking water that contains less than 0.14 ug/L
of HFPO-DA. In the event that DEQ or DHHS should determine that the current health goal of
0.14 ug/L should be modified, Chemours will demonstrate that the GAC Treatment System
meets that revised goal or will provide an alternative means for providing drinking water that
meets the revised goal.
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Page 2 of 2
When Chemours’ obligation to operate and maintain the GAC Treatment System ends,
Chemours will monitor annually the source water at the Property for a period of five (5) years.
Chemours will pay all expenses to remove the GAC Treatment System entirely and return the
Property to its condition before the equipment’s installation.
Condition 4. Chemours will be responsible for personal injury or property damage caused by
negligence in the performance of the work described in Conditions 1, 2, and 3 or by malfunction
of the GAC Treatment System. Chemours will not be responsible for any damage caused by
any other persons, including but not limited to the negligence of the Owner(s) or their invitees or
licensees.
Condition 5. Chemours and its contractor(s) may have access to the Property during normal
business hours (Monday through Friday between 8:00 a.m. and 5:00 p.m.) to perform the
installation, connection, sampling and any necessary restoration. When Chemours and its
contractor(s) must enter the primary living space, it will seek with the Owner(s) a mutually
agreeable time to do so.
Condition 6. Owner(s) grant Chemours the authority to obtain at its cost all necessary federal,
state, and county permits for completion of the work described above on behalf of Owner(s) as
required.
This Agreement is understood and intended by Chemours and the Owner(s) to be without any
admission of liability or fact, and nothing in this Agreement shall be considered as an admission
by Chemours or the Owner(s) in any proceeding.
This Agreement reflects the complete agreement between Chemours and the Owner(s) with
respect to the subject matter covered herein and supersedes any and all prior agreements on
the same subject matter. This Agreement may not be altered, amended, changed, terminated
or modified in any respect except in writing agreed to by both Chemours and the Owner(s).
Owner(s)’ consent is provided on this date, _______________________________ by:
-2-
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Page 2 of 2
Agree by Chemours:
Kevin P. Garon, Principal Remediation Project Manager, representing The Chemours Company
Printed Name, Title
____________________________ _______________________________
Chemours Signature Date
-3-
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ATTACHMENT 4
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Dear Resident,
On _____, 2017, we contacted you with results from the well water sample we
collected from your property on ____, 2017. That sample was taken as part of a program to
determine whether trace levels of the chemical compound HFPO-DA (sometimes referred
to as “Gen X” or “C3 dimer”) are present in local drinking water wells, including yours. As
we reported to you and the State (NCDEQ and NCDHHS) at that time, preliminary results
indicated the level of GenX found in your well was above the provisional state health goal
of 140 parts per trillion (ppt) announced last year by DHHS. It’s our understanding that
NCDEQ confirmed that finding with you in subsequent correspondence, following their
independent review of the data.
Chemours has recently completed testing of drinking water treatment technology with the
goal of offering affected residents a reliable whole house treatment solution in place of the
bottled water currently being provided. The selected technology, which uses granular
activated carbon (GAC) as the treatment medium, is specifically designed for removing a
wide range of contaminants from drinking water in residential well applications. It has been
employed successfully to treat contaminated groundwater at many locations throughout the
United States. Independent laboratory testing and a pilot study sponsored by Chemours has
demonstrated the capability of this technology to reliably and consistently remove GenX to
levels below the provisional health goal when installed and maintained in continuous
operation in accordance with Chemours’ implementation plan. The test results and an
associated report on the pilot study that have been shared with NCDEQ and the Water
Districts of Cumberland and Bladen Counties show that as a general matter, the level of
GenX removal achieved provides an ample margin of safety below the provisional health
goal consistent with the specified maintenance plan for the technology to be installed.
(Chemours will share these same materials with any residents who wish to see them).
Chemours’ submission to NCDEQ also includes the details of Chemours’ plan to offer these
treatment systems to affected residents free of charge, including installation and operating
costs. Along with the treatment system, Chemours is also offering to collect verification
samples on a regular routine basis for independent laboratory analysis to confirm GenX
removal and determine the required timing of GAC cartridge replacement needed to meet
acceptable performance. These results will be reported to residents as received, and
Chemours will bear the cost of GAC cartridge replacement.
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Chemours will continue bottled water service to residents who take advantage of this offer,
until the initial verification test results for each installed system show it is performing
satisfactorily. Based on testing to date, we have every confidence that each system will
perform as expected; we will be conducting home-by home testing of every unit and share
results with NCDEQ, to give homeowners and their families confidence in this program.
We believe this solution is the best option we can offer affected residents to remedy drinking
water impacts and address the inconvenience of the current bottled water program. We
sincerely hope that all residents who are offered this solution, including you, will accept..
The offer is unconditional and requires no commitments, costs, or obligations other than
coordinating with our installation and sampling teams to conduct their work. .. If you are
interested in exploring this option further, please call (number TBD) at your earliest
convenience to schedule an in-home visit where we will provide further details and collect
information on your well and installation preferences. We will respond to requests on a first
come basis, and, will work diligently to promptly respond to all requests.
In the interim, we confirm that Chemours will continue to provide you bottled drinking water
free of charge pending verification of system performance once installed. Bottled water
remains available at the Chemours facility for your pick-up between 9 am and 8 pm;
Chemours will also arrange to deliver water to your home if you wish. Should you wish to
speak with someone at Chemours regarding future deliveries, please call (number TBD) and
leave your name, address, and phone number. Until such time as we can implement whole-
house treatment at your residence, please continue to refer to the Fact Sheet prepared by
DHHS, which contains information about GenX and their guidelines for safe use of your
water for non-drinking purposes. If you choose to decline this offer of treatment, please sign
below and return this letter in the enclosed self-addressed stamped envelope.
Chemours remains committed to being a responsible member of this community and a good
neighbor. As always, we are working with the agencies to remedy this matter transparently
and as quickly as possible, and we sincerely apologize for the inconvenience caused to you
and your family. Please call (number TBD) with any questions.
Ellis McGaughy
Plant Manager
Chemours Fayetteville Works
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Dear Resident,
At this time, Chemours is offering to monitor free of charge for GenX in drinking water
wells that showed initial results between 100 ppt and the provisional health goal of 140 ppt.
Sampling would be conducted on a quarterly basis (i.e., once every three months) for up to
three additional quarterly events in order to demonstrate that these wells remain below the
provisional health goal. If the concentration of GenX is detected above 140 ppt in any of
those monitoring events, Chemours will immediately upon receiving such results offer to
provide bottled water free of charge as well as to offer installation of a whole-house
treatment system using technology proven to remove GenX from drinking water, as an
alternative to bottled water once installed and tested to verify satisfactory treatment
performance. Treatment system installation and operating costs will be borne by Chemours
and will be offered free of any costs or charges to residents whose wells are found to exceed
the provisional health goal.
Because the initial result reported for your well exceeds the 100 ppt threshold for this
program, Chemours is offering to include your well in this additional monitoring program.
If you choose to accept this offer, please contact us at (number TBD) at your earliest
convenience and provide your name, address and a phone number where we may reach you.
We will contact you with further information and to schedule a visit to explain this program
and arrange for sampling at times that are convenient to you. While Chemours
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representatives will conduct the sampling, the analyses will be performed by an independent
laboratory certified by the State. Your sampling results will be promptly reported to you
and NCDEQ. If you choose to decline this offer, please sign below and return this letter in
the enclosed self-addressed stamped envelope.
Chemours remains committed to being a responsible member of this community and a good
neighbor. As always, we are working with the agencies to address this matter transparently
and as quickly as possible, and we sincerely apologize for any concern caused to you and
your family. Please call (number TBD) with any questions.
Ellis McGaughy
Plant Manager
Chemours Fayetteville Works
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Attachment 2
Supplemental Declaration of Dana Sargent
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PORl(ITY JAVA
Steven Schnitzler
CEO, Port City Java
4000 Chopra Dr.
Wilmington, NC 28412
RE: PFAS Well Contamination - New Hanover County
[sent by email to: [email protected], sus:[email protected]
[email protected], [email protected], [email protected]
[email protected], [email protected], [email protected],
[email protected]. [email protected], [email protected],
[email protected], [email protected], [email protected],
[email protected], [email protected], [email protected], dhays:@nhcgov.com,
[email protected], [email protected], on January 5. 2022]
Dear Secretary Biser, Assistant Secretary Masemore, Mr. Scott. Mr. Waldroup, CFPUA Board of Directors.
and New Hanover County Commissioners,
My name is Steven Schnitzler and I am the CEO of Port City Java, and a resident of New Hanover County,
whose home is on a private well. My home, as well as my businesses. located throughout New Hanover,
Pender and Bruns'Nick counties, have all been affected by the contamination of both public and private
sources of drinking water from the discharge and emissions of GenX and other PFAS by Chemours from
their Fayetteville Works plant.
I have followed the news of the initial lawsuits and consent order with interest, hoping that the issues would
be positively resolved. While there has been progress, I believe that unless further legal and enforcement
actions are initiated, the citizens affected by this will continue to be left behind.
I am aware that efforts are underway to reclaim some or all of the expenses associated with the needed
upgrades at the Sweeney Water Treatment Facility to install and maintain granular activated carbon
(GAC) filtration, as well as actions in Brunswick County surrounding their installation of a reverse osmosis
(RO) system. Those are important first steps.
In viewing the service maps from CFPUA, I note that there are quite a large number of citizens, including
those on private wells like myself and my family, and others whose water supply is not serviced by the
Sweeney Water Treatment facility, who are still exposed to contaminated drinking water.
I am currently acting as an organizer of sorts for my neighborhood, Samsara Estates. where many of the
wells that have been tested have come back with substantial PFAS contamination. Some have come
back with minor contamination, and some with less than detectable levels. I cannot say that I have a
tremendous amount of trust in the testing, in that we all have wells that are only feet apart in some
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instances, and the source water is the same. This seems to be suspect at best. We have been sharing
information as to well depth and locations and test results, to try to get some idea of where we stand.
A number of neighbors are now receiving bottled water, due to contamination per the consent order.
Some have had 3 under sink RO systems installed. These systems do not actually cover all of the water
sources in ANY of the homes in the neighborhood. Let alone the fact that we don't yet know of the
dangers posed through showering in it, swimming in a pool of it, or eating produce from a garden
watered by it - it is an interesting conversation to have with house guests when one has to inform them to
not drink the water from the guest bathroom; it is poisoned.
We have numerous neighbors, including my wife, that have suffered from breast and other cancers. We
have numerous neighbors suffering from thyroid issues. I cannot personally draw a direct line between the
contamination of our wells and these illnesses, but in my wife's case, we also lived downtown, and drank
public water there, and she taught at Williston Middle School for over 22 years, and drank water there as
well, all prior to any mitigation efforts.
Per the consent order, there is an option for annual well testing and that's nice. However, none of that
actually solves the problem of the wells being contaminated, and the solution presented falls short of an
actual fix. The water within the aquifer migrates, as does the contamination.
The ONLY solution that we see is Chemours being held to account not only for the costs of the CfPUA
(and other) public water supply upgrades to protect our drinking water, but to force Chemours to pay for
tapping in all private well owners to provide them with the same level of relief that other citizens of New
Hanover County serviced by the Sweeney plant receive.
It is not fair to have a private well, that was poisoned by this company, be the cause to force us to pay for
tapping in as the only real fully satisfactory measure to fix the problem for all of us. The under-sink solution is
inadequate.
I also shudder to think what conversations we will feel forced to have when we have to disclose the
contamination of our homes' water to perspective buyers, and what that does to the value of our
property. There is no way that we will be able to sell our home for full value due to the fact that it is now
public knowledge that our wells are contaminated with toxic chemicals. Many folks rely on the value of
their home for their retirement and wellbeing.
There are a lot of citizens dealing with this, and a lot that simply think they are safe due to the fact that
they are on a private well. You all know this is incorrect, and that Chemours is at fault; no one else should
have to pay to fix it. It is well past time that corporations are held to account for their actions. I am a
business owner and resident. I expect no less for my company, and no less for anyone else's.
Please push for every possible remedy for all of the citizens of the area that you serve. We all should have
equal access to clean water, regardless of its source. Having said that, since the groundwater and aquifer
is already contaminated, that source can only come from Cf PUA.
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One last note: the RO systems, will, over time, add MORE chemicals to the local environment, as the filters'
contents and wastewater will be added to the local waste water stream, only to need to be filtered out
once again. That will gradually build the amount of filtration required, and lead to increased costs and
impaired effectiveness, leading once again to the inevitable conclusion that all homes being on CFPUA
at Chemours' expense is the only viable end result.
To DEQ, I urge you to use your regulatory power- as the only entity in our state with this power- to protect
human health and the environment and require Chemours to fund municipal hookups, including payment
for 20 years of the associated water bills to all well owners in the affected area.
To CFPUA, I urge you to do all that you can to win the current lawsuits and to work with DEQ to provide
municipal connections to all wells in New Hanover County.
To New Hanover County Commissioners, I urge you to use your power as elected officials to support this
necessary effort to ensure environmental and public health and economic prosperity of your constituents
and the county as a whole.
There can be no other choice. If you do not serve the citizens of this county and state, then who do you
serve?
Steven Schnitzler
CEO, Port City Java
CC:
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Attachment 3
Supplemental Declaration of Dana Sargent
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< Cape Fear River Watch > < Center for Environmental Health > < Clean
Cape Fear < > Democracy Green < > NC Black Alliance < > Toxic Free NC >
May 3, 2022
Radhika Fox
Assistant Administrator
Office of Water
US Environmental Protection Agency
1200 Pennsylvania Avenue, N.W., Mail Code 4101M
Washington, DC 20460
We are six public health and environmental groups committed to protecting communities in
Eastern North Carolina impacted by the extensive contamination of the Cape Fear River basin by
Per- and Polyfluoroalkyl Substances (PFAS) released by Chemours’ Fayetteville Works. Because
of this contamination, over 500,000 residents consume drinking water containing numerous
PFAS. These contaminants include the Hexafluoropropylene Oxide (HFPO) Dimer Acid and its
ammonium salt, commonly referred to as GenX.
Our groups have long been concerned about the health threats of drinking-water exposure to
GenX and other PFAS contaminating the Cape Fear River. In late 2020, we petitioned the
Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA) to
require Chemours to conduct health and environmental effects testing on 54 PFAS lacking critical
data for protection of the health of communities.1 GenX was included in this petition and the
studies we recommended would have helped fill the serious data gaps now identified by EPA.
We are writing to express strong opposition to Chemours’ March 18, 2022 request under the
Information Quality Act (IQA) to withdraw and correct EPA’s October 25, 2021 GenX
Chemicals Toxicity Assessment. This EPA assessment was developed in a lengthy process with
two rounds of peer review and a full opportunity for public comment. Its findings are
meticulously documented and conform to EPA and National Academy of Sciences guidelines for
chemical risk assessments. Chemours’ IQA request adds nothing new to these scientific
deliberations. Instead, it seeks to rehash issues that have already been fully vetted and carefully
considered by EPA and its peer reviewers.
As acknowledged by Chemours, 2 the purpose of the IQA request is to delay an imminent EPA
drinking water health advisory that would recommend reductions in GenX levels in drinking
1
On December 28, 2021, EPA responded to the petition, concluding that petitioners had justified the need
for testing but that it would not require almost all the studies that the petition requested.
2
The IQA request states (pp. 33-34) that “EPA’s health advisory should be based upon a revised
assessment for HFPO-DA that addresses and corrects the procedural and scientific deficiencies noted
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water which would protect against the risks of harm demonstrated by the assessment. EPA
should reject this ploy to delay public health protection by denying the IQA request and issuing
the advisory as soon as possible. This will immediately benefit our communities by enabling the
State of North Carolina to compel Chemours to provide alternate water supplies to thousands of
residents whose drinking water contains unsafe levels of GenX and other PFAS.
Significantly, on February 23, 2022, the Court of Justice of the European Communities issued a
lengthy decision denying Chemours’ challenge to the European Chemicals Agency’s July 2019
listing of GenX as a “substance of very high concern.” The Court rejected several of the scientific
arguments made by Chemours in its IQA request.
GenX has been produced, initially as a byproduct and subsequently as an intentional product, by
Chemours and its predecessor DuPont and discharged into the Cape Fear River for over four
decades. For most of that period, GenX was a byproduct in the production of vinyl ethers. After
Chemours submitted premanufacture notices for GenX under the Toxic Substances Control Act in
2008, DuPont began commercial production of GenX, touting it as a “sustainable replacement”
for perfluorooctanoic acid (PFOA), which was being phased out as a processing aid in the
manufacture of fluoropolymers.
As described (pp. 3-4) in the EPA assessment, GenX has been consistently detected in source
water and finished drinking water, as well as in private wells, throughout communities near and
downstream of the Fayetteville plant. Conventional and advanced water treatment processes in
use in the Cape Fear basin have shown limited effectiveness in reducing GenX levels in finished
drinking water. Exposure to GenX and other PFAS derives not only from drinking water but from
other pathways, including air emissions, rainwater, and locally grown food. 3 The health effects of
GenX are likely additive to or synergistic with several other Chemours-produced PFAS found in
the drinking water and blood of Cape Fear residents. 4
The final GenX toxicity assessment reinforces our longstanding concerns about the risks of
historical and ongoing exposure to GenX in Cape Fear communities. The EPA assessment
herein and incorporates the results of the in vitro study and liver pathology research. The health advisory
should not be undertaken until after a revised assessment can be peer reviewed.”
3
The EPA assessment indicates (p. 28) that intake of GenX by Cape Fear residents “is expected to occur
by dermal exposure (i.e., contact of exposed parts of the body with water containing GenX chemicals
during bathing or showering, and dishwashing) and inhalation exposure (e.g., volatilization of the GenX
chemicals from the water during bathing or showering, or while using a humidifier or vaporizer” or as a
result of air emissions from the Chemours facility.
4
For example, in 2019, North Carolina State University’s Center for Human Health and the Environment
collected samples of water from 84 private wells and blood from 153 community members in Cumberland
and Bladen Counties near the Fayetteville plant. The samples were analyzed for 26 PFAS. In May of 2020,
the Center released the results of the private well sampling. Eleven PFAS, including GenX, were found in
over 50 percent of the wells.
2
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concludes that GenX causes adverse effects on the liver, kidneys, immune system and
development of offspring, and is associated with an increased risk of cancer. It sets a Reference
Dose (RfD) of 3×10-6 mg/kg/day for chronic exposure. This RfD represents the daily exposure to
GenX that is likely without appreciable risk to humans over a lifetime. Since North Carolina
residents have been ingesting GenX in drinking water continuously for several decades, exposure
above the RfD poses a serious health risk to Cape Fear communities. Indeed, the RfD likely
understates this risk because it does not account for exposure to at least 350 other PFAS in the
region’s drinking water and how GenX might interact with them in the human body and our
environment, nor does it account for other pathways of exposure to GenX.
Recent monitoring data show that GenX levels in many samples of drinking water near and
downstream of the Chemours plant and in personal drinking water wells result in exposure above
the RfD.5 Thus, Eastern North Carolina residents are now ingesting GenX at concentrations
determined to be harmful by EPA.
Recognizing the urgency of reducing GenX exposure in drinking water, EPA has announced that
it will issue a GenX drinking water health advisory in the Spring of 2022. A consent order
between Chemours and North Carolina Department of Environmental Quality (NCDEQ) requires
the company to provide permanent replacement drinking water supplies to any owner of a private
well “contaminated by concentrations of GenX compounds in excess of . . . any applicable health
advisory” (emphasis added). On November 3, 2021, NCDEQ put Chemours on notice of the need
to revise its Drinking Water Compliance Plan under the consent order in accordance with EPA’s
RfD once the drinking water advisory is issued. Thus, prompt issuance of the advisory will trigger
Chemours’ obligation to provide alternate water supplies to owners of wells with GenX
contamination that exceeds the RfD. A delay in issuing the advisory while EPA considers
Chemours’ unwarranted IQA request would relieve the company from meeting this obligation,
perhaps for years, continuing to expose residents to unsafe GenX contamination.
EPA released its draft toxicity assessment for GenX in November 2018. It accepted public
comments on the draft for 60 days, from November 21, 2018 to January 22, 2019. Along with
many stakeholders and experts, Chemours and its scientific consultants submitted extensive
comments. Five independent external peer reviewers reviewed the draft assessment, responding in
5
In 2018, the North Carolina Department of Health and Human Services (NCDHHS) set a preliminary
health goal for GenX of 140 ppt. The goal was based on an RfD of 0.0001 mg/kg/day and assumed
drinking water intake for bottle-fed infants and a relative source contribution of 20% to account for
potential exposure to GenX chemicals from other media and routes. The new EPA RfD is 3% of the RfD
used by NCDHHS. Using the same assumptions made in calculating the NC preliminary health goal, a
“safe” drinking water level based on the EPA RfD would therefore be 4.2 ppt. Recent GenX levels in
finished drinking water as measured by the Cape Fear Public Utility Authority and Brunswick County
Public Utilities have ranged between 3-16 ppt. For comparison, these utilities measured total PFAS levels
in finished water of 93 and 94 ppt in early March 2022. Monitoring of private wells in the Fayetteville
area in 2019 by the GenX Exposure Project showed a median GenX concentration of 103 ppt.
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writing to eight detailed charge questions. The reviewers were strongly supportive of the EPA
draft. EPA convened a supplemental seven member peer-review panel in the spring of 2021 to
address new information received since the initial comment period, including the results of a
National Toxicology Program (NTP) Pathology Working Group (PWG) review and recent
reproductive/developmental toxicity data raising concern about impacts of GenX on pregnancy.
EPA posed five charge questions to the supplemental review panel, which, as before, provided
detailed written responses. Again, the reviewers were supportive of EPA’s approach and none
raised major concerns about the draft final assessment.
When EPA finalized the assessment in November 2021, it released a 69 page document fully
responding to each of the public comments, including those submitted by Chemours and its
consultants. A review of the comments demonstrates that numerous independent scientists, states,
and other organizations called for strengthening EPA’s draft assessment, a path that EPA
ultimately followed. In addition to addressing public comments, EPA issued reports presenting
and responding to the recommendations and feedback of the initial and supplemental peer review
panels. These documents demonstrate the care and thoroughness with which the Agency
considered the input of stakeholders, including Chemours, and external scientists.
The alleged “flaws” in the EPA assessment identified in the Chemours’ IQA request include (pp.
3-4) the following:
● The rodent liver effects underpinning the assessment are peroxisome proliferator-
activated receptor alpha (PPAR-alpha) effects that are not relevant to humans;
● The assessment relies on observations by the National Toxicology Program Pathology
Working Group (NTP PWG) that do not follow evaluation criteria set forth in the
peer-reviewed scientific literature;
● The assessment uses inappropriate and significantly inflated uncertainty factors that
are inconsistent with EPA’s own guidance and practice in other toxicity assessments;
● EPA has not taken into account available epidemiological evidence showing no
increased risk of cancers or liver disease attributable to exposure to GenX.
As shown below, with the strong support of the peer reviewers, EPA fully addressed these issues
in its final assessment and supporting materials, explaining the scientific justification for its
approach and responding to commenters, including Chemours and its consultants, who made
arguments that now form the basis for the IQA request.
From the outset of the assessment process, EPA highlighted this issue and asked for feedback
from its external reviewers and stakeholders. Thus, its charge to the first peer review panel posed
the following question (p.10):
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The draft assessment for GenX chemicals identifies liver effects as a potential human
hazard. EPA evaluated the available evidence for liver effects, including the potential
role of PPARα, using Hall et al. (2012) criteria for adversity.
a. Please comment on whether the available data have been clearly and
appropriately synthesized for these toxicological effects.
b. Please comment on whether the weight of evidence for hazard
identification has been clearly described and scientifically justified.
c. Please comment on whether the conclusions regarding adversity are
scientifically supported and clearly described.
The reviewers generally responded that the weight of evidence for adverse liver effects was
supported by the data, clearly described and scientifically justified. None advised EPA that liver
effects were irrelevant to humans because of the PPAR-alpha mechanism.
EPA’s final toxicity assessment devotes several pages (pp. xii, 82-86) to the Mode of Action
(MOA) for liver effects, concluding that “the constellation of liver lesions observed in the rodent
are relevant to human health and not a result of PPARα-induced cell proliferation unique to
rodents.” In support of this conclusion, EPA determined (pp. 84. 86) that:
Although there is evidence for a PPARα MOA in the liver, particularly in the high-dose
groups in the available studies, data indicate that liver toxicity extends beyond a single
PPARα-based MOA. For example, liver necrosis was consistently observed in rodent
toxicity studies with HFPO dimer acid ammonium salt and was reaffirmed by the NTP
PWG’s review of the 90-day subchronic study in mice and the reproductive and
developmental toxicity study in mice (appendix D), which suggests that cytotoxicity is
also a possible MOA (emphasis added).
.............................
Taken together, the available data indicate that a PPARα MOA is plausible in the liver in
response to GenX chemical exposure, especially at doses greater than 0.5 mg/kg/day;
however, there are not yet enough data to conclude that PPARα activation is the sole
mechanism underlying the liver effects associated with exposure to GenX chemicals. For
example, there are no studies investigating GenX chemical exposure in PPARα-null
mice. It is worth noting that exposure to PFOA has been demonstrated to induce liver
effects in PPARα-null mice, including hepatocellular hypertrophy (Minata et al., 2010).
Additionally, available studies indicate that other MOAs (e.g., PPARγ, mitochondrial
dysfunction, and cytotoxicity) are also plausible. The data are not adequate to conclude
that any of the MOAs described here are the sole toxicologic MOA for HFPO dimer acid
and/or ammonium salt in the liver and especially in other organ systems (emphasis
added).
EPA also explained (p. 86) why, despite the possible role of PPARα receptors, the liver effects
on which its RfD were based were indicative of potential toxicity in humans:
Because liver effects such as increases in liver weight and hepatocellular hypertrophy
(also referenced here as cytoplasmic alteration per NTP PWG’s review) can be associated
with activation of cellular PPARα receptors, EPA evaluated observed liver effects
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resulting from HFPO dimer acid ammonium salt exposure against the Hall criteria (Hall et
al., 2012). These criteria indicate that increased liver weight and hepatocellular
hypertrophy must be accompanied by histologic or clinical pathology indicative of liver
toxicity to be considered adverse. Histologic or clinical pathology indicative of liver
toxicity can include changes in liver enzyme concentrations in the serum, necrosis,
inflammation, and degeneration. With these criteria in mind, EPA concluded that some of
the observed liver effects such as single-cell and focal necrosis, increased apoptosis, and
increases in serum liver enzymes indicate toxicity of relevance to humans as opposed to
PPARα-induced cell proliferation unique to rodents (emphasis added).
In its response to comments document, EPA directly addressed (p.36) the assertions of
Chemours’ consultants – repeated in the IQA request – that the liver effects should be
discounted as irrelevant to humans because of a PPARα MOA:
In short, Chemours’ claims were exhaustively addressed during the toxicity assessment process
and further consideration of these claims would serve no purpose except delay.
DuPont scientists who originally reviewed the liver pathology slides from the two critical studies
conducted by the company determined that GenX caused necrosis and apoptosis, consistent with a
non-PPARα MOA. Seeking to challenge these findings, Chemours and its experts commissioned
a reanalysis by a consulting pathologist of the slides which purported to show that, for both
studies, apoptosis was the primary adverse effect of note in the liver. To resolve these conflicting
interpretations, EPA took the unusual step of requesting that NTP convene a PWG to provide an
independent, expert review of selected tissues from the two studies.
Known as the gold standard in the scientific community, NTP PWG reviews are a rigorous
process in which a team of pathologists collaborate to reach a consensus on the classification of
reported effects using standardized and broadly accepted diagnostic criteria. As EPA summarized
the work of the GenX PWG in its response to comments (p. 12):
As part of this PWG, one pathologist reviewed all the slides from the two studies that Du
Pont submitted to EPA and classified liver cell death according to the INHAND Organ
Working Group’s diagnostic criteria, which describe how pathologists can distinguish
between apoptosis and single-cell necrosis in standard H&E-stained tissue sections
(Elmore et al., 2016). Other liver effects were classified according to the INHAND
document containing standardized terminology effects were classified according to the
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According to the response to comments (pp. 12-13), the PWG “confirmed single-cell necrosis and
focal necrosis in the mid- and high-dose groups of both studies” and found that these effects
exhibited a dose-response relationship. “Findings of apoptosis were observed but limited to the
highest dose groups in both sexes in both studies.” Thus, the “PWG results confirm the
conclusions presented in” the original DuPont studies “that the observed liver lesions, which
include single-cell necrosis, are treatment-related adverse effects.” EPA shared the results of the
PWG report with the supplemental peer review panel, which agreed that the constellation of liver
effects identified by the PWG provided a sound basis for EPA’s determination of subchronic and
chronic RfDs.
There have now been four pathology reviews of the two DuPont studies. The rigorous and
definitive PWG analysis rejects the reviews performed for Chemours, reaffirms the original
DuPont findings and supports EPA’s RfDs. Chemours may not like this outcome but has
identified no credible reason to revisit it.
Uncertainty Factors
Long-standing EPA practice in developing RfDs is to apply Uncertainty Factors (UFs) to account
for limitations and gaps in the available data and the possibility that further testing would identify
additional end-points of concern or known adverse effects at lower doses. EPA issued detailed
guidance for selecting UFs in 2002 and has followed this guidance in numerous assessments. In
the final GenX toxicity assessment, EPA relied on the guidance to calculate five separate UFs
which, when combined, resulted in a total UF of 3000 for determining a chronic RfD. The
assessment (pp. 92-97) explains the basis for each UF in detail. Chemours claims, however, that
“[b]etween EPA’s draft and final Toxicity Assessment, the total uncertainty factors increased
exponentially (from 300 to 3000), notwithstanding that the final Toxicity Assessment
incorporates additional data and studies (and thus, in truth, there is less, not more, uncertainty)
(emphasis in original)” (p.25). Chemours’ reasoning does not stand up to scrutiny.
EPA’s charge to the supplemental peer review panel (pp. 3-4) fully explained why two of the UFs
were increased from 3 to 10 in the final assessment:
EPA has identified new toxicological and toxicokinetic information published since the
last peer review of this document that demonstrate accumulation of GenX chemicals in the
whole embryo and identified additional adverse effects that EPA had not considered in
applying a database uncertainty factor of 3. Based on this new information, EPA has
increased the uncertainty factor to 10 to address database limitations on the impact of
GenX chemicals exposure specifically on reproduction and development.
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Because a 2-year chronic mouse study is unavailable, the impact of a longer dosing
duration on both the incidence and severity of liver effects in mice is unknown. This is
important because the new analysis by NTP indicates that the duration of exposure
appears to play a larger role than previously understood in the progression and severity of
liver effects resulting from GenX chemical exposure, as evidenced in female rats. . . .[A]
2-year chronic study in the mouse would provide information critical to understand the
progression of these liver effects. Specifically, it is possible that a longer duration study
would result in an increased frequency and/or magnitude of response and could also reveal
additional adverse effects at lower doses than currently observed in the existing less-than-
chronic mouse studies.
The supplemental peer reviewers were fully supportive of increasing the two UFs, as the
responses of Dr. Elaine Faustman of the University of Washington (pp. 16, 21) illustrate:
This reviewer agrees with the conclusion of the internal draft that in fact, the uncertainty
has increased. This should not be surprising given the intensity of investigation of the
perflorinated compounds and the expanded portfolio of endpoints that are being revealed.
The internal report identifies additional uncertainties in observations in immune response,
molecular responses that appear to be beyond PPAR alpha dependent responses and which
identify further concerns regarding developmental sensitivity and kinetics. Since the
uncertainties have now been expanded and cover both kinetic and dynamic considerations,
the increase of the uncertainty factor from 3 to 10 is appropriate.
...........................
This reviewer agrees with a selection of uncertainty factor of 10 to account for
extrapolation from a subchronic to a chronic exposure duration. Detailed support for this
number is provided by EPA and includes the following considerations: complexity of
kinetics especially over time and lifestage, clarification of the adversity of the hepatic
alterations observed in the Dupont study used for the critical effect (see the NTP re-
assessment and use of the most current pathology classification guidance) that now
highlight more concern over the long term manifestations of these adverse impacts in the
hepatic system, further identification of cholesterol changes and concerns over adiposity
and chronic health impacts and dose response for these complex endpoints across sex and
time.
While Chemours touts (p. 25) the large “number of toxicity studies and amount of toxicity data
available” on GenX, the EPA assessment presents a very different picture: it enumerates the many
gaps in the GenX data-base that create large uncertainties about the range and severity of its
adverse effects and require substantial UFs to assure that the RfD is adequately protective of
exposed communities. (Attachment 1 lists these data-gaps.) Because Chemours could have
reduced these uncertainties by investing in more testing but failed to do so, it has no standing to
complain about EPA’s UFs.
Claiming that “[t]he flaws in EPA’s HFPO-DA Toxicity Assessment are further corroborated by
real-world epidemiological data,” Chemours’ IQA request faults EPA (p. 30) for failing to
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consider 2017 data from NCDHHS purporting to show that “rates of liver and other cancers
are generally lower in North Carolina counties with exposures to [GenX] than the rates reported in
the U.S. general population, in the state of North Carolina, and in North Carolina counties without
alleged exposure to [GenX]” (emphasis in original).
The data Chemours cites is merely a tabulation of cancer incidence data in different North
Carolina counties. This tabulation is not an epidemiological study and was not published in the
peer reviewed literature. Moreover, according to NCDHHS itself, Chemours’ description of the
data is simply incorrect. As reported in a recent article in The Intercept:
NCDHHS did not conclude that rates of liver and other cancers are generally lower in
North Carolina counties with exposures to [GenX] than the rates reported in the U.S.
general population, in the state of North Carolina, or in North Carolina counties without
alleged exposure” to GenX, Catie Armstrong, a spokesperson for the department, wrote in
an email to The Intercept. Armstrong also noted that while overall cancer rates in the four
counties studied were similar, in New Hanover County rates of testicular cancer were
elevated over a 20-year period and rates of liver cancer were higher over a five-year
period. The cancer rates collected by the health department are descriptive, Armstrong
said, and “only a comprehensive research study can provide information about whether a
specific exposure might be associated with increased rates of cancer.
The EPA toxicity assessment (p. 95) emphasizes that, in addition to other data gaps, “there are no
human toxicity data from epidemiological studies in the general population or worker cohorts
evaluating the health effects of exposure to these GenX chemicals.” Although based on limited
and incomplete information, NCDHSS’s finding of elevated testicular and liver tumors in New
Hanover County is cause for concern and underscores the need for a comprehensive epidemiology
study of Cape Fear communities. Our TSCA testing petition sought to require Chemours to fund
such a study but the TSCA program – unjustifiably in our view -- has refused to impose this
requirement.6 As epidemiology plays a critical role in recent EPA toxicity assessments to support
drinking water standards for PFOS and PFOA, the importance of developing robust human data
on GenX and other PFAS in North Carolina drinking water has become even more compelling.
In sum, the Chemours’ IQA request to withdraw and correct the EPA GenX toxicity assessment is
lacking in scientific merit. EPA should promptly deny the request and issue the GenX drinking
water health advisory as soon as possible to provide enhanced protection to at risk Cape Fear
communities.
If you have any questions about the letter, please contact our counsel Bob Sussman at
[email protected] or 202-716-0118.
6
The petition response cites two limited and inadequate studies underway in North Carolina and ATSDR
studies being conducted in other areas of the country focusing mainly on PFAS in fire-fighting foam, not
GenX and other PFAS found in drinking water and human blood in Cape Fear communities. As EPA’s
recent toxicity assessments indicate, epidemiological data are meaningful only where the population
studied was exposed to the compounds of interest – in this case, GenX and other PFAS manufactured by
Chemours.
9
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Respectfully submitted,
10
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“Because the mouse presents with liver necrosis at much lower doses and shorter durations (0.5
mg/kg/day at 53–85 days) than the rat and because the mode of action for these liver effects is
uncertain (see section 6), it is critical to have a 2-year chronic study in the mouse to understand
the progression of these liver effects.” (p.93)
“[W]hen evaluating the available endpoints and studies to ensure comprehensive characterization
of the potential toxicity, there are important deficiencies that need to be considered, particularly
for understanding developmental toxicity. . . . For GenX chemicals, there are reproductive or
developmental effects of concern in mice . . . that have not been studied yet.” (p.93)
“[O]ther database deficiencies include the absence of a full two-generation reproductive and
developmental toxicity study to understand if latent effects occur as a result of exposure to GenX
chemicals during development (e.g., adverse cardiometabolic outcomes in adult offspring
associated with placental insufficiency). . . . These effects . . .highlight the importance of having
a full two-generation reproductive and developmental toxicity study.” (p. 94-95)
“[O]ther database gaps are noted for GenX chemicals with respect to potential immune,
hematological and neurological effects.”(p.95)
“Additionally, there are no human toxicity data from epidemiological studies in the general
population or worker cohorts evaluating the health effects of exposure to theseGenX chemicals.”
(p. 95)
“The combined GenX chemicals immunotoxicity dataset was found to be incomplete as it did not
include sufficient measures of immunopathology, humoral immunity, cell- mediated immunity,
nonspecific immunity, or host resistance, but the available studies are suggestive of a potential
immune hazard. Data on the potential for these GenX chemicals to impact aspects of immune
function beyond immunosuppression are lacking. Additional studies, therefore, would be useful to
support a more conclusive determination of immunotoxic potential.” (p. 95)
“The potential neurodevelopmental effects that might result from the disruption of these thyroid
hormones are unknown and require additional investigation at lower doses.” (p. 96)
“Given the evidence that the liver is the target organ for toxicity and the primary organ for tumor
development, additional research is needed using chronic duration exposures in mice.” (p. 103).
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“Data for the elucidation of differential susceptibility dependent on life stage (e.g., developing
embryo/fetus, women of reproductive age, or pregnant women) are not available. . . . No human
toxicity or epidemiological studies are available in the literature that address early developmental
or reproductive life stage.” (p. 10
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Health, and three other organizations on the draft toxicity assessment for GenX
chemicals. These comments are included in the Index to the Administrative Record
River Watch, Clean Cape Fear, Democracy Green, North Carolina Black Alliance,
and Toxic Free North Carolina following the transfer of their case to the Eastern
North Carolina Black Alliance and Democracy Green voluntarily dismissed their
claims on November 1, 2022, but the other plaintiffs remain in the case.
I declare under penalty of perjury that the foregoing is true and correct.
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Exhibit 1
to Declaration of Simi Bhat in Support of Motion to Intervene
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David P. Ross,
Assistant Administrator, Office of Water
Environmental Protection Agency
Washington DC 20009
We, the undersigned five non-profit organizations, are writing to comment on EPA’s
draft toxicity assessments for perfluorobutane sulfonic acid (PFBS) and
hexafluoroproyplene oxide (or GenX chemicals). These are two chemicals in the
massive family of synthetic per- and poly- fluorinated alkyl substances (PFAS), with
over 5,000 PFAS CAS-name substances (US EPA 2018a). PFAS are characterized by
incredible durability, which manifests as extreme persistence in the environment. The
PFAS chemicals that have been studied show potent toxicity to internal organs, lipid
metabolism, as well as the immune and endocrine systems.
Given the number of people exposed to these chemicals, their persistence in the
environment, and the public concern about them, it is critical that this toxicity
assessment provide the information necessary to guide regulators and communities in
their efforts to protect themselves. In this letter, we outline areas where the EPA has
taken steps in the right direction (e.g., the methodology in the systematic review of
PFBS) as well as areas that need to be strengthened (e.g., adequately accounting for
the uncertainty related to the limited availability of data for both chemicals). We
recognize the importance of this assessment and that communities exposed to these
chemicals are eager for the EPA to complete this assessment, but we strongly urge the
EPA to update and strengthen this assessment by ensuring that it relies upon a more
robust data set and/or adequately accounts for the insufficiencies.
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Docket EPA-HQ-OW-2018-0614-0001
Introduction.
PFBS and GenX are two of the hundreds of PFAS compounds in widespread use in the
United States (Lerner 2018). PFBS is a component of aqueous film forming foam
(AFFF) firefighting foams (Backe et al. 2013) and textile treatments (Danish
Environmental Protection Agency 2015) and GenX chemicals are a processing
technology used to form fluoropolymers. While exposures to GenX chemicals appear to
be more limited to regions of the United States where fluorochemicals are manufactured
and used, PFBS is much more widely detected in drinking water. People are often
exposed to PFAS mixtures, via consumer products, contaminated drinking water, or
accumulation in the food supply. Whether exposures are the result of fluorochemical
production and use or the use of AFFF firefighting foams, EPA should assume that
those communities with intense exposure to PFBS and GenX chemicals will generally
have high exposure to legacy PFAS compounds as well.
We support the EPA Integrated Risk Information System (IRIS) program’s state of the
science, transparent systematic review criteria for PFBS. The IRIS program’s
systematic review framework received high praise in a thorough public and scientific
review by the National Academies in 2014 and again in 2018. The IRIS systematic
review framework should be adopted more widely by other divisions of EPA. In
particular, it should supplant the broadly criticized and severely flawed systematic
review being promoted by the EPA TSCA program. We also support EPA’s choice of
critical studies and endpoints for a quantitative assessment of health risks for both
chemicals.
However, we are deeply concerned that these draft assessments do not include a
sufficient margin of safety when considering the major gaps in our understanding of
their individual and shared toxicological properties. EPA's quantitative assessment fails
to adequately reflect the uncertainty about low dose toxicity of PFBS and GenX
chemicals. The assessment proposed a surprisingly low uncertainty factor of 3 to
account for the lack of thorough toxicity testing, yet the database for both chemicals is
quite limited and neither have robust data for critical endpoints including developmental
impacts to the immune and neurological systems.
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Docket EPA-HQ-OW-2018-0614-0001
The current process of regulating toxic chemicals places scientists and government
agencies at a disadvantage because public health protection is reliant on data-intensive
risk assessments. PFAS chemicals are not included in most environmental statues.
Therefore, information on production and releases to the environment is generally not
disclosed. This is especially troubling for PFAS chemicals, as the fluorochemical
industry has a history of failing to report information about PFAS exposures in workers
and the general population, serious adverse effects in PFAS-exposed workers, and
adverse effects in industry-performed laboratory studies.
The overall trend in PFAS chemistry is a shift from highly toxic and bioaccumulative
classes of relatively data rich compounds to related chemicals with slightly more
favorable environmental profiles yet little or no safety data. Because PFBS and GenX
discharged into the environment cannot be efficiently removed from groundwater, soil
and sediments, and because they are so persistent, the larger margin of safety will add
greater assurance of protection in the event that future evidence proves a greater
potency than EPA currently estimates.
Our comments address four major issues. Section 1 outlines the reasons that EPA’s
draft quantitative assessments for PFBS and GenX chemicals do not fully account for
uncertainties regarding the potency of both chemicals. It also addresses the fact that
individual potency is not the appropriate approach for gauging the safety of current
exposures to these specific chemicals and determining whether on-going emissions
should be curtailed. Section 2 addresses EPA’s use of systematic review for PFBS and
GenX chemicals. Section 3 provides detailed comments about EPA’s quantitative
assessment for GenX chemicals and Section 4 provides similar comments for PFBS.
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There is very little published data on effects of PFBS and GenX chemicals in people.
Human epidemiology is challenged by the fact that people have simultaneous
exposures to dozens of PFAS chemicals, and by the number of study subjects and
duration of follow up that would be needed to capture rare or subtle health effects.
Furthermore, shorter-chain chemicals appear to accumulate in different organs and
tissues. A rare autopsy study of 20 human cadavers conducted in Spain detected the
highest concentration of PFBS in lung and kidney tissue (Perez et al. 2013), suggesting
that risk managers should consider whether low detections in human blood and urine
are appropriate assurance of rapid metabolism and lack of concern for shorter-chain
PFAS chemicals.
As discussed in sections 3 and 4 below, EPA should explore the use of alternative
methods to scale between animals and humans, and account for the fact that laboratory
studies may not accurately reflect the risks of low dose exposure to PFBS and GenX
chemicals in people, especially developing infants and children.
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The European Food Safety Authority also allows for the consideration of additive effects
for chemicals that target the same health endpoint, even when mode of action is
unknown (EFSA 2014), as does the National Academy of Sciences (National Research
Council 2008, 2009). The Netherlands pioneered this approach for PFAS with a relative
potency estimate for liver hypertrophy using experimental data for 11 perfluoroalkyl
sulfonates and perfluoroalkyl carboxylates and read across assumptions for 7 additional
PFAS (RIVM et al. 2018). While the potency of PFBS and GenX (FRD-902/-903) on
liver hypertrophy were far lower than PFOS and PFOA, they should be considered to
add to the burden of PFAS-related liver injury in the American population. EPA must
promote similar assessments for other PFAS related health outcomes with potential for
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EPA proposes a total uncertainty factor of 100 to 300 for every endpoint in the two draft
assessments except chronic exposures to PFBS. In comparison, EPA used a combined
uncertainty factor of 300 for PFOA, a chemical with hundreds more toxicological
studies. Despite the relatively complete database for PFOS and PFOA, and the use of
uncertainty factors to account for extrapolations from laboratory studies to human
health, the available evidence suggests that EPA’s practices of quantitative risk
assessment were not fully protective of human health.
EPA translated its reference doses for PFOS and PFOA into a combined drinking water
guideline of 70 parts per trillion. However, several human studies for PFOS and PFOA
find sensitive effects in populations at this level. The Scientific Advisory Committee
advising the state of Michigan reviewed select epidemiology endpoints from the C8
Science Panel study and determined that several epidemiology studies reported
increased risks of ulcerative colitis and several cancers at concentrations in the range of
EPA’s water guideline (Michigan PFAS Science Advisory Panel 2018). The Committee
recommended that Michigan take epidemiology studies into account when setting
drinking water exposure values, and set advisory limits for novel PFAS chemicals based
on similar chemical structures and toxicity.
Human epidemiology suggests effects to the immune systems at serum levels that are
relatively common in the American population. Philippe Grandjean calculated the
benchmark dose level for vaccine antibody responses in PFOA and PFOS to be
approximately 1 ug/L serum, which would correspond to a drinking water limit of less
than 1 ng/L (Grandjean 2018).
In this light, we are concerned that EPA’s quantitative toxicity assessments for PFBS
and GenX chemicals are premature. Importantly, toxicology studies using even lower
doses and examining effects on sensitive endpoints such as the immune system and
mammary gland have not yet been conducted for PFBS and GenX chemicals. Several
major research efforts are underway that will provide more information about these
chemicals, as well as ways to assess groups of PFAS chemicals for similar effects. EPA
should commit to updating these toxicity assessments and incorporating new studies on
additive or synergistic effects including any data published before the draft documents
are finalized. For example, major in vitro screening efforts are underway at EPA and the
National Toxicology Program (NTP) that could help determine shared toxicological
properties of PFBS and GenX chemicals in-vitro. Also, several new abstracts to be
presented at the Society of Toxicology meeting in March 2019, indicate forthcoming in-
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vivo data for GenX (Blake and Fenton 2019; Cope et al. 2019). Once finalized EPA
should also commit to reevaluating these assessments to reflect the best available
information on health risks.
EPA’s quantitative toxicity assessments will inevitably be used as a tool to gauge the
safety of ongoing PFAS emissions. But the Norwegian Environmental Agency has taken
a different approach to assessing these very persistent compounds, concluding that,
“Given the irreversibility of environmental contamination a threshold concerning the
level of risk caused by the continued manufacture, use and emissions of PFBS in the
long term cannot be derived with any certainty” (ECHA 2018). Deviating from a risk-
based approach, Norway nominated PFBS for special classification as a Substance of
Very High Concern under Europe’s REACH legislation, and is taking precautionary
action to restrict further emissions.
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Sciences, Engineering, and Medicine suggesting the need for programmatic reform
(National Academies of Sciences 2018).
We were pleased to see the adoption and implementation of rigorous systematic review
methodology in line with current best practice recommendations by the Office of
Research and Development (ORD), specifically in the draft PFBS assessment. In
particular, we support the use of the study confidence rating, which is in line with best
practices for assessing risk of bias and closely aligns to the methods used by the NTP’s
Office of Health Assessment and Translation (OHAT) (OHAT 2015). Importantly, the
PECO (populations, exposures, comparators and outcomes) statement clearly outlines
the criteria for inclusion and exclusion of studies in the assessment. We also support
the transparent GRADE-like methods used for evidence integration in the draft PFBS
assessment.
Finally, we appreciate the display of extracted PFBS data in HAWC, which made it very
easy to evaluate the statements made in the draft PFBS assessment. To this end, we
also appreciate that EPA made public the industry studies that have not been peer
reviewed, but comprise the bulk of the literature that the draft assessments are based
on. Without access to these reports, it would not have been possible to fully evaluate
these EPA draft assessments. Moving forward, we encourage EPA to make the data for
GenX chemicals available in HAWC when finalizing the assessment.
We assume that the draft assessment on GenX chemicals was completed using EPA
review methods that were in place before the complete adoption of systematic review
best practices. Given that the GenX assessment was not conducted following best
practices in systematic review, we encourage EPA to reformat and reevaluate the data,
if necessary, so that the GenX assessment, like the PFBS assessment, adheres to best
practice guidelines for systematic review. It is confusing to the public that these two
assessments were released by EPA at the same time but were conducted using
different methods.
The draft assessment on GenX chemicals would benefit from increased transparency
regarding the inclusion and exclusion criteria that were used during the study screening
process, as this information is not explicitly stated in Section 3.3.2 (though it was
available in Appendix A, it was not referred to in the text). While not completely adhering
to all recommended best practices, EPA did provide in Appendix B of the draft
assessment on GenX chemicals, a data quality evaluation that is similar in content to
the study confidence rating used in the draft PFBS assessment. It is important to note
that we do not support derivation of a numerical value for this type of evaluation, as that
is not in line with current best practices for systematic review methodology. The US
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“Quality scoring systems have not been validated. Studies assessed as excellent
quality using one scoring method may be subsequently assessed as lower
quality using another scoring method (Moher et al. 1996). Moreover, with an
emphasis on risk of bias, the Systematic Review more appropriately assesses
the quality of study design and conduct rather than the quality of reporting.”
(Institute of Medicine 2011).
In summary, experts warn against the scoring system. The current state of the science
for evaluating clinical and environmental health research is to describe or document
each component of the assessment tool separately, without trying to calculate an overall
numeric score.
We also note that one portion of the literature search for GenX chemicals, that for
HFPO dimer acid, was completed in July 2017 and has not been updated. Given how
rapidly research on PFAS is being published, EPA should have, at the very least,
updated the search for HFPO dimer acid when the search for HFPO dimer ammonium
salt was conducted in January/February 2018. Moving forward, the EPA should ensure
that all literature searches are conducted within six months of final publication, and that
the cut-off date is reported in the assessments, as these represents best practices in
systematic review.
One additional important aspect about GenX chemicals is that future health
assessments should consider the solvent used for preparation and storage of the
chemicals, as it has recently been brought to light that GenX chemicals degrade in
DMSO. Though not an issue for the studies included in this analysis, the choice of
solvent and stability of the chemicals is an important study aspect that should be
considered in future reviews of GenX chemicals and possibly other PFAS.
GenX chemicals and PFBS are of high concern to citizens across the US. It is of great
importance that EPA is responsive to emerging environmental health concerns in a
timely manner. However, a major tenet of systematic review is increased transparency,
and best practice guidelines in systematic review methodology require the publication of
a review protocol in order to improve transparency. The need for public comment and a
finalized protocol in EPA assessments was also recently highlighted by The National
Academies (National Academies of Sciences 2018). For example, in addition to not fully
adhering to systematic review best practices in the draft assessment on GenX
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chemicals, we note that “GenX chemicals” has been too narrowly defined by the
literature search terms used, which we will discuss in more detail below. This is
important feedback for EPA that could have possibly been provided at the outset of the
review, had a protocol been made available before the assessment was conducted.
Importantly, we note that the US EPA IRIS program recently (12/19/18) listed five
additional PFAS as upcoming program products (EPA 2018b) and we strongly
encourage EPA to make protocols for these assessments publicly available for
comment before conducting the reviews.
GenX is a technology that enables the use of fluoropolymers without the use of PFOA.
Although HFPO dimer acid and its ammonium salt are the main chemicals involved in
this fluoropolymer manufacturing process, there are likely other PFAS chemicals that
are part of the GenX process. A community exposed to HFPO dimer acid and its
ammonium salt from GenX processing will likely be concurrently exposed to other PFAS
chemicals involved in the process and the resulting byproducts and transformation
products as well.
For example, a non-targeted analysis of Chemours wastewater discharge into the Cape
Fear River in North Carolina showed, in addition to HFPO dimer acid, at least three
additional PFAS (PFMOAA, PFO2HxA, PFO3OA) and two polyfluoroalkyl ether sulfonic
acid byproducts (Nafion 1 and Nafion 2) (US EPA 2017). Similar to GenX chemicals, the
estimated concentrations of PFMOAA, PFO2HxA, PFO3OA dropped significantly after
Chemours stopped discharging GenX chemicals. Thus, it is believed that these three
PFAS were part of the same wastewater discharge that included GenX chemicals (NC
DEQ 2017b). In addition to high concentrations of the legacy PFAS, PFOA and PFOS,
these and other GenX related chemicals are now being detected in exposed citizens.
The GenX Exposure Study, set in the Lower Cape Fear River Basin, recently reported
to study participants that there were four new PFAS found in participants’ blood (Nafion
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2, PFO4DA, PFO5DoDA and Hydro-EVE) (NC State Center for Human Health and the
Environment 2018; Smart 2018).
The chemical and toxicological similarities between GenX chemicals and other PFAS
should also be used in the assessment of GenX toxicity. For example, in addition to liver
effects, immune and hematological effects were observed at low doses. However, the
EPA failed to adequately incorporate these effects, stating on page 51 of the
assessment that there is “some uncertainty regarding the biological significance of both
the hematological and immune endpoints,” and that currently “little or no data on the
potential for GenX chemicals to impact aspects of immune function beyond the
immunosuppression (e.g., allergic responses and autoimmunity) exist.” Though
immunotoxicity data is limited for GenX chemicals, immunotoxicity is a common effect of
PFAS. Adverse effects on immune system function, in addition to changes in early
markers of immunotoxic effects, have also been associated with more well-studied
PFAS. The chemical and toxicological similarities between GenX chemicals and other
PFAS reduce the uncertainty regarding biological significance of immune endpoints for
GenX chemicals. Especially considering the evidence of these effects for the class of
PFAS, the EPA should not assume that there is no harm or effects when there are data
gaps.
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For example, on page 39 the EPA states that delays in genital development may be
related to observed effects on body weight during the pre-weaning period but does not
discount the possibility of this effect being related to GenX chemical exposure. This
conclusion is in contrast to the authors’ dismissal of the genital developmental delay as
only a consequence of body weight, and not a direct effect of GenX chemical
administration. Another example is EPA’s conclusion that the occurrence of combined
pancreatic acinar adenomas and carcinomas is related to GenX chemical exposure,
despite the authors’ conclusion that the evidence is equivocal.
However, there are some instances where further clarification of study data should be
provided. For example, EPA reports no reproductive effects associated with exposure to
GenX chemicals, but there was a mention of 11 mating pairs not able to successfully
produce litters in DuPont-18405-1037 (Dupont Chem 2010a). No further discussion on
this was provided. As there were 100 pairs in the study, this indicates 11% were unable
to successfully mate. The significance of this effect cannot be assessed without
reporting of how these pairs are distributed among the exposure groups.
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equivalent dose based on liver effects in adults would compare to the human equivalent
dose based on developmental effects in infants and children. This uncertainty should be
acknowledged, and the EPA should explore alternative approaches to extrapolating
from animal to human doses that are relevant to infants and children to better address
this uncertainty.
Furthermore, this approach does not account for differences in toxicokinetics between
animals and humans, which for PFAS are often vastly different. Even within animal
models, data suggest a potentially complex toxicokinetic profile for HFPO dimer acid
when dosing occurs over multiple days (Rushing et al. 2017). When male mice received
doses of 1, 10 and 100 mg/kg/day for 28 days, their serum levels did not reach a steady
state. This indicates possible changes in toxicokinetics after repeated dosing.
Depending on the specific PFAS, human clearance time can be an order of magnitude,
or more, higher than in animal models. Therefore, the Netherland’s National Institute for
Public Health and the Environment (RIVM) determined that although the elimination
rates for GenX are faster than PFOA in animal models, without data in humans, it is not
possible to make assumptions on the toxicokinetics of GenX chemicals in humans
(RIVM et al. 2016).
Due to the uncertainty from lack of human toxicokinetic data on GenX chemicals, RIVM
calculated and applied an additional uncertainty factor to account for the potential
kinetic difference between animals and humans (RIVM et al. 2016). RIVM postulated
that the vast differences in clearance rates between animals and humans may be due to
species differences between organic anion transporters (OATs). Differences in OATs
could result in stronger reabsorption of anions, like the anion forms of PFOA and HFPO
dimer acid, from the lumen of the kidney back into the blood in humans (Yang et al.
2010).
It is possible that the shorter half-live of GenX in animal models is due to little to no
reabsorption by OATs in these species. However, RIVM reasoned that it could not be
assumed this would be the same for humans, due to the genetic differences of the
OATs between animal models and humans (Yang et al. 2010). RIVM states, “contrary to
other perfluorinated compounds, no data are available for FRD-902 [GenX chemical] to
confirm whether the fast elimination and absence of accumulation as seen in several
animal species also applies to humans. In view of the above, an additional toxicokinetic
assessment factor is applied to take into account the uncertainty in the human
elimination rate of FRD-902.”
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This additional toxicokinetic factor used by RIVM is based on the difference in half-lives
between cynomolgus monkeys and humans for PFOA. A half-life ratio was calculated
using a half-life of 1378 days in humans (Olsen et al. 2007) and of 20.9 days in male
cynomolgus monkeys (Butenhoff et al. 2004) resulting in an additional toxicokinetic
factor of 66 (1378 / 20.9). This additional uncertainty factor to account for the potential
kinetic difference between animals and humans is an example of an alternative
approach to extrapolating animal doses to human doses for PFAS that do not yet have
human toxicokinetic data.
F. Database uncertainty.
As mentioned in our overarching comments, there are significant database limitations
for HFPO dimer acid and its ammonium salt. These include:
Both the HFPO dimer acid and its salt can be transported through air (DuPont
CCAS 2009). Inhalation could be a significant exposure route, especially in areas
where GenX processing occurs. In 2017 the North Carolina Division of Air Quality
estimated that despite some cutback in emissions, the Chemours Fayetteville
Works plant emitted approximately 2,700 pounds of GenX chemicals per year
(NC DEQ 2018a) and GenX chemicals have been found in rainwater up to 7
miles from the Chemours Fayetteville Works plant (NC DEQ 2018b). Minimal
dermal absorption of the HFPO dimer acid ammonium salt has also been
demonstrated (DuPont 2008), however, there is a lack of information on the
dermal absorption potential or toxicity of the HFPO dimer acid.
● No human data.
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The single chronic study was performed in rats, which are less sensitive than
mice to GenX chemicals. An additional limitation of this study is that there were
higher than normal early deaths across all study groups (DuPont-18405-1238,
2013) (Dupont Chem 2010b).
● Limited peer-reviewed, independently funded studies for HFPO dimer acid and
its ammonium salt.
Of the studies that assess health effects of GenX, only three were peer-reviewed.
Of these three, one was independently funded (Rushing et al. 2017), one was
funded by DuPont (Caverly Rae et al. 2015), and one was independently funded
but excluded from the assessment (Wang et al. 2017).
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in the draft assessment for GenX chemicals that the Body Weight 3/4 approach is not
suitable for estimating an equivalent dose in infants and children (US EPA 2018c). EPA
derived RfD based on kidney effects in adult rats and thyroid effects in newborn mice.
Given the lack of toxicokinetic information available in humans, rats, and mice,
especially at different life points, it is unclear how appropriate the default Body Weight 3/4
scaling approach is for estimating human equivalent doses. This uncertainty should be
acknowledged, and the EPA should explore alternative approaches to extrapolating
from animal to human doses that are relevant to infants and children to better address
this uncertainty.
Regarding the derivation of RfDs for kidney effects, it is unclear in Tables 13 and 18,
why a lack of neurodevelopmental effects is viewed as a limitation in evaluating the
confidence in the database for deriving subchronic and chronic RfDs for kidney effects.
At no prior point in the document does EPA indicate that neurodevelopmental changes
are an expected downstream event following the observed kidney effects. In fact, this
stands in contrast to the evidence integration judgement (Table 7) that lists the following
factors as increasing support for a hazard:
“1) the two high-confidence studies with the longest exposure durations reported
consistent effects on kidney histopathology in male and female rats (females
were more sensitive), and 2) the histopathological effects related to inflammation
were largely dose-dependent and of a concerning magnitude, although primarily
at high doses (300 or 600 mg/kg-d), and the following as factors that decrease
support for a hazard: 1) there was inconsistency in kidney weight changes across
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studies, and 2) findings are from a single laboratory and species, with the
following note included: the general lack of effects on other pathology endpoints
in the shorter term studies was not considered to decrease support for hazard, as
this was not interpreted as inconsistent.”
Thus, this rationale for decreased confidence in the database of studies investigating
effects on the kidney appears arbitrary, and we strongly encourage EPA to reevaluate
this decision. On the other hand, it is logical to judge the confidence in the database for
thyroid effects as medium, given the lack of studies evaluating the functional
implications related to altered T4.
For the RfDs based on kidney effects, the lack of studies on neurodevelopmental effects
is more appropriately addressed in the uncertainty factor for database deficiencies.
Unlike the judgment of the confidence in the body of evidence (i.e. confidence in the
database), which should evaluate the studies related to the identified hazard, the
uncertainty factor for database limitations should address the database of PFBS studies
more globally and indicate if the most sensitive adverse effects have or have not been
evaluated for PFBS. We agree with EPA that studies evaluating endpoints that are
extremely sensitive to disruption by other PFAS (including mammary gland
development and immunotoxicity) have not yet been conducted for PFBS, and this is
clearly a database deficiency.
To be clear, we suggest that the uncertainty factor for database deficiencies should be
10 for each of the draft RfDs. This value for database deficiencies should be applied to
all RfDs calculated in this draft assessment because at this time there are no
immunotoxicology studies or evaluations of mammary gland development for PFBS,
both of which are endpoints that are sensitive to disruption by other PFAS. To this point,
effects for a variety of endpoints are seen at doses of PFOA that are one to two orders
of magnitude lower than the lowest doses used in the available PFBS studies.
Furthermore, there are currently only a limited number of independently funded studies
of PFBS available. Of the 15 available animal publications, only the 20-day
developmental study by Feng et al. 2017, and the as of yet un-peer reviewed 28-day
study from NTP are independently funded. In addition, a LOAEL-to-NOAEL uncertainty
factor of at least 3 should be applied for the RfDs based on thyroid hormone because
the critical effect was in newborn mice and it is unclear how appropriate the default
Body Weight3/4 scaling approach is for estimating human equivalent doses in infants.
Also, EPA inconsistently applied the subchronic to chronic uncertainty factor of 10 when
deriving the chronic RfDs, and the reasoning for this is unclear.
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● It was unclear why some of the epidemiological publications were not listed in
HAWC. On page 22 of the assessment it states that were seven epidemiological
studies presented in 10 publications, and an additional seven studies that were
excluded based on study evaluation (Table 4). This indicates that there should be
17 epidemiological publications in HAWC, yet there are only 13, including six of
the seven excluded publications.
● Likewise, it is unclear why some of the animal publications are not listed in
HAWC. On page 22 of the assessment it states that there were 10 studies
presented in 15 papers. All 15 papers are listed on page 25 of the assessment,
yet only 12 are listed in HAWC.
● It is unclear why some of the answers to the study confidence rating questions in
HAWC appear in italics and others do not.
● In some of the data pivots in HAWC (e.g. that for PFBS T3 (effect size, animal)
the legend indicates a red square for significance, but in fact the plot uses a red
circle.
● There were data entry errors in the Feng study. There were errors in the line for
“animal husbandry” for the P0 Females, specifically the temperature and
humidity. Further, in the F1 data some of the uterine effects (e.g. uterine
diameter and others) have “ovary” listed as the organ.
● The funding line should be updated for two animal studies: 3M should be listed
as funding source, not just in the extraction comments for Bijland, 2011, 1578502
and Bayer should be listed as the funding source for Bomhard, 1996, 3859928
● It is unclear what “adequate-deficient” means in the rationale for the study
confidence rating question for outcome ascertainment in Dong et al. 2013
pertaining to asthma severity score.
In conclusion, we urge the agency to strengthen its final assessments and have outlined
dozens of ways in which the current drafts discount the significant uncertainties about
the individual chemicals’ effects on human health. EPA should commit to updating its
assessments when new data is available to reduce uncertainties in low dose health
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effects for these chemicals. It must take urgent action to control direct releases of PFBS
and GenX chemicals into the environment.
Sincerely,
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Exhibit 2
to Declaration of Simi Bhat in Support of Motion to Intervene
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24
Plaintiffs, Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy
25
26 Green, The NC Black Alliance, and Toxic Free NC (“Plaintiffs”), as and for their Complaint, allege as
27 follows against Defendants Jane Nishida, as Acting Administrator of the Environmental Protection Agency
28 (“EPA”), and the EPA:
1
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COMPLAINT .
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INTRODUCTORY STATEMENT
1
2
1. Plaintiffs are nonprofit public health and environmental justice organizations, based in Oakland,
3
California and Eastern North Carolina, concerned about the extensive environmental contamination caused
4
by Per- and Polyfluoroalkyl Substances (“PFAS”) and the absence of scientific data on the impacts of this
5
contamination on the health of at risk communities. On October 14, 2020, plaintiffs petitioned defendant
6
7 Environmental Protection Agency (“EPA”) under Section 21 of the Toxic Substances Control Act
8 (“TSCA”) to require health and environmental effects testing on 54 PFAS manufactured by The Chemours
9 Company (“Chemours”) at its chemical production facility in Fayetteville, North Carolina, downstream of
10
the communities that plaintiffs represent. The petition sought issuance of a rule or order under section 4
11
of TSCA compelling Chemours to fund and carry out this testing under the direction of a panel of
12
independent scientists. Although the petition demonstrated that the 54 PFAS meet the criteria for testing
13
14 in section 4(a) of TSCA, defendant EPA denied the petition on January 7, 2021.
15 2. PFAS have raised significant concern in the US and globally because of their persistence and
16 potential to bio-accumulate, widespread presence in living organisms, products, and the environment, and
17 demonstrated adverse health effects at low doses. In the last few years, several PFAS have been identified
18
in drinking water sources serving nearly 300,000 people in the Cape Fear watershed, in human blood and
19
in environmental media, including air emissions, surface water, sediment, stormwater, groundwater and
20
locally grown produce. This contamination has been linked to the Chemours facility in Fayetteville, which
21
23 3. This action seeks judicial review of the petition denial as authorized in section 21(b)(4)(A of TSCA
24 and the Administrative Procedure Act (“APA”). Plaintiffs ask the Court to compel defendants to initiate a
25
proceeding under section 4(a) of TSCA to issue a rule or order requiring Chemours to fund the studies
26
identified in the petition. The Court should grant this relief because, as plaintiffs demonstrated in their
27
petition and will demonstrate to the Court by a preponderance of evidence, the 54 PFAS meet the standard
28
2
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for judicial intervention in section 21(b)((4)(B)(i) of TSCA because (1) available information is
1
“insufficient to permit a reasoned evaluation of the[ir] health and environmental effects” and (2) the 54
2
10 5. This action is also filed under section 706 of the APA, 5 U.S.C. § 706, under which a reviewing
11 court shall “hold unlawful and set aside agency action, findings, and conclusions found to be . . . . arbitrary,
18 15 U.S.C. §2620(b)(4) because plaintiff Center for Environmental Health resides in the District.
19
PARTIES
20
21
9. Plaintiff Center for Environmental Health (“CEH”) is a non-profit organization working to protect
22
children and families from harmful chemicals in air, food, water and in everyday products. Its vision and
23
mission are a world where everyone lives, works, learns and plays in a healthy environment. CEH protects
24
people from toxic chemicals by working with communities, businesses, and the government to demand
25
26 and support business practices that are safe for human health and the environment. CEH is headquartered
27 in Oakland, California, but members of its staff work in North Carolina and partner closely with locally-
28
3
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based organizations to address concerns relating to PFAS and other chemicals that threaten the health of
1
North Carolinians.
2
3 10. Plaintiff Cape Fear River Watch (“CFRW”) is a grassroots environmental nonprofit based in
4 Wilmington, North Carolina whose mission is to protect and improve the water quality of the Cape Fear
5 River Basin for all people through education, advocacy and action. Since its founding, over 25 years ago,
6
it has worked on a wide variety of water quality issues – educating and organizing the community to take
7
action, partnering with researchers, influencing decision makers, and holding polluters accountable. Since
8
learning of the nearly four decades of PFAS contamination of the Cape Fear River, the drinking water
9
10 supply for nearly 300,000 people, and a vital ecological and economical resource to the region, Cape Fear
11 River Watch, in partnership with academia and the Southern Environmental Law Center, has worked to
12 stop the source of pollution, understand and explain the impacts to human health and the ecosystem, and
13 ensure that those responsible are held accountable.
14
11. Plaintiff Clean Cape Fear (“CCF”) is an all-volunteer, grassroots community group based in the
15
Wilmington, NC area. Its members include educators, environmentalists, doctors, faith leaders, scientists,
16
veterans, and concerned residents all working together to hold Chemours/DuPont accountable for decades
17
18 of pollution. CFF was formed shortly after learning that toxic chemicals linked to cancer and other serious
19 health problems were detected in finished tap water as a result of Chemours’ discharges to the Case Fear
20 River. These discharges and other environmental releases from the facility impact five counties with
21
nearly300,000 residents drinking contaminated tap water downstream from the facility and over 3,500+
22
well owners with contaminated groundwater near the Fayetteville, NC area.
23
12. Plaintiff Democracy Green (“DG”) is an organization created and run by native North Carolinians-
24
of-color to address the systemic impacts burdening our most climate impacted and disenfranchised
25
26 communities across North Carolina. DG works in partnership with communities, groups and organizations
27 across the historic U.S. South, in addition to areas hailing the descendants of U.S. chattel slavery and
28 Indigenous sovereign nations. Communities represented by DG have seen the horrific damage caused by
4
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PFAS to North Carolinians and DG cannot stand idly by while the corporations responsible are not held
1
accountable. Democracy Green stands against corporate polluters and the harmful impact of their
2
4 13. Plaintiff The NC Black Alliance (“NCBA”) is working toward state-level systemic change by
5 strengthening the network of elected officials representing communities of color throughout the state and
6
collaborating with progressive, grassroots networks on intersecting issues. NCBA believes that the
7
communities impacted by climate disasters also face the direct impact of health disparities created by
8
exposure to dangerous chemicals, such PFAS. It is NCBA’s conviction that all people have the right to
9
10 clean air, clean water, access to health care, and a thriving economy.
11 14. Plaintiff Toxic Free NC (“TFNC”) advances environmental health and justice in North Carolina
12 by advocating for safe alternatives to harmful pesticides and chemicals. Founded in 1986, the organization
13 has played a leading role in state-wide pesticide reform and has contributed to national efforts strengthening
14
regulatory protections to protect vulnerable communities and the environment from petrochemical
15
pollution. TFNC believes that PFAS contamination is at the nexus of clean water concerns in North
16
Carolina and that, while high levels of PFAS have been detected in drinking water across the state, the full
17
18 health impact on the exposed residents of North Carolina is still unknown. Together with other
19 organizations in North Carolina, TFNC advocates for regulatory solutions to prevent further PFAS
20 discharges into our environment and cleanup the PFAS already present. TFNC represents thousands of
21
North Carolina residents whose drinking water has been contaminated and are deeply concerned about the
22
consequences for their health.
23
15. Defendant Jane Nishida, named in her official capacity as Acting Administrator of EPA, has
24
authority for the implementation of TSCA and is responsible for assuring that the Agency exercises its
25
27
28
5
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16. Defendant EPA is an agency of the United States Executive Branch and, under the direction of
1
Acting Administrator Nishida, is charged with implementing the provisions of TSCA, including by
2
4
STATUTORY BACKGROUND
5
6
17. TSCA was enacted in 1976 to create a national program for assessing and managing the risks of
7
chemicals to human health and the environment. The need for this comprehensive framework for managing
8
chemical risks was described as follows in the Senate Report on the original law:
9
10 As the industry has grown, we have become literally surrounded by a man-made chemical
environment. We utilize chemicals in a majority of our daily activities. We continually wear, wash
11 with, inhale, and ingest a multitude of chemical substances. Many of these chemicals are essential
to protect, prolong, and enhance our lives. Yet, too frequently, we have discovered that certain of
12 these chemicals present lethal health and environmental dangers.
13 Senate Rept. No. 94-698, 94th Cong. 2d Sess. (1976) at 3.
14
18. Among the goals stated in TSCA section 2(b), 15 U.S.C. §2601(b), is that “adequate information
15
should be developed with respect to the effect of chemical substances and mixtures on health and the
16
environment and that the development of this information should be the responsibility of those who
17
18 manufacture and those who process such chemical substances and mixtures.”
19 19. This policy is embodied in section 4 of TSCA, which provides EPA with broad authority to require
20 industry to test its chemicals to determine their risks to human health and the environment. Recognizing
21
the need for more testing to support chemical risk determinations, the 2016 TSCA amendments streamline
22
section 4 by authorizing EPA to issue orders in addition to rules requiring development of data.
23
20. Section 4(a)(1)(A)(i) authorizes EPA to require testing where it determines that –
24
the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or
25
mixture, or that any combination of such activities, may present an unreasonable risk of injury to
26 health or the environment (emphasis added).
27 21. In Chemical Manufacturers Association v. U.S. Environmental Protection Agency, 859 F.2d 977
28 (1988), the D.C. Circuit concluded that “[b]oth the wording and structure of TSCA reveal that Congress
6
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did not expect that EPA would have to document to a certainty the existence of an ‘unreasonable risk’
1
before it could require testing.” It added that TSCA’s legislative history demonstrates that “the word ‘may’
2
3 in section 4 was intended to focus the Agency's attention on chemical substances ‘about which there is a
4 basis for concern, but about which there is inadequate information to reasonably predict or determine the
5 effects of the substance or mixture on health or the environment.’"
6
22. The D.C. Circuit acknowledged that “Congress did not intend to authorize EPA to issue test rules
7
on the basis of mere hunches” but stressed that EPA need not demonstrate that exposure or toxicity is
8
“probable.” Instead, EPA may “rely on inferences in issuing a section 4 test rule, so long as all the evidence
9
11 potential toxicity; this can include toxicity data on chemical analogs since “Congress explicitly
12 contemplated that EPA would base test rules on comparisons among structurally similar chemicals.”
13 23. In addition to a “may present” finding, section 4(a)(1)(A)(i) directs EPA to make two further
14
determinations before requiring testing: (1) there is “insufficient information and experience” with which
15
the chemical’s effects on health and the environment “can reasonably be determined or predicted”; and (2)
16
testing is “necessary to develop such information.” The first determination will be justified whenever data
17
18 either do not exist or are inadequate to support scientifically supportable conclusions about the chemical’s
19 adverse effects. The second determination will be warranted where EPA concludes that the testing to be
20 required is the only way to obtain sufficient information about these effects and that such information
21
cannot be derived from other sources.
22
24. Once EPA makes these findings, it must require that testing be conducted “to develop information
23
with respect to the health and environmental effects for which there is an insufficiency of information and
24
experience” and which are “relevant to a determination” whether the substance “does or does not present
25
27 25. Under section 4(b)(2)(A), a broad range of studies may be required under test rules or orders. These
28 may include studies to determine “carcinogenesis, mutagenesis, teratogenesis, behavioral disorders,
7
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cumulative or synergistic effects, and any other effect which may present an unreasonable risk of injury to
1
health or the environment.” Studies to be conducted may include “epidemiologic studies, serial or tiered
2
3 testing, in vitro tests, and whole animal tests.” The rule or order can also require development of
4 information “for the assessment of exposure or exposure potential to humans or the environment.”
5 26. Under section 4(b)(3), testing rules or orders must place responsibility for developing the required
6
data on the entities who manufacture and/or process the chemical to be tested. Section 4(b)(1) provides
7
that the rule or order must prescribe the “protocols and methodologies” for conducting testing and
8
procedures and deadlines for submitting interim and final test results.
9
10 27. These requirements are enforceable under TSCA and non-compliance may give rise to civil and
11 criminal penalties under section 16 and specific enforcement under section 17.
12 28. Testing under TSCA section 4 can be required on chemicals produced for intentional use or as
13 byproducts during a commercial chemical manufacturing operation. EPA defines “byproduct” under
14
TSCA as “any chemical substance or mixture produced without a separate commercial intent during
15
the manufacture, processing, use, or disposal of another chemical substance or mixture.” 40 C.F.R. §
16
712.3(a).
17
18 29. Since TSCA’s inception, section 21 of the law has contained a petition process by which citizens
19 can seek to compel action by EPA under different provisions of the law. 15 U.S.C. § 2620. The D.C.
20 Circuit has recognized “TSCA’s unusually powerful citizen-petition procedures.” Trumpeter Swan Society
21
v EPA, 774 F.3d 1037, 1939 (D.C, Cir. 2014). EPA is required to respond to the petition within 90 days.
22
If EPA denies the petition or fails to act within 90 days, Section 21 empowers the petitioner to file a civil
23
action in federal district court to “compel the [EPA] Administrator to initiate a rulemaking proceeding as
24
requested in the petition.” 15 U.S.C. §2620(b)(4)(A).
25
26 30. As amended in 2016, section 21(a) authorizes citizens to petition for, inter alia, issuance of a rule
27 or order under Section 4 requiring manufacturers and processors to conduct testing on chemical substances
28 and mixtures. Id. § 2620(a). Under Section 21(b)(4)(B), where the petition sought issuance of a rule or
8
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order under section 4, “the petitioner shall be provided an opportunity to have such petition considered by
1
the court in a de novo proceeding.” 15 U.S.C. § 2620(b)(4)(B).
2
3 31. For petitions seeking issuance of rules or orders under section 4, Section 21(b)(4)(B)(i) directs the
4 district court to “order the Administrator to initiate the action requested by the petitioner” if it
5 “demonstrates to the satisfaction of the court by a preponderance of the evidence” that “(I) information
6
available to the Administrator is insufficient to permit a reasoned evaluation of the health and
7
environmental effects of the chemical substance to be subject to such rule or order; and (II) in the absence
8
of such information, the substance may present an unreasonable risk to health or the environment . . . “ 15.
9
10 U.S.C. §2620(b)(4)(B)(i))I)-(II).
11 32. Section 26(c)(1) of TSCA authorizes EPA to treat a group of chemical substances as a “category”
12 under section 4 and other TSCA provisions. 15 U.S.C § 2625(c)(1). If the Agency designates chemicals as
13 a “category,” testing or other requirements prescribed by EPA would apply to each substance in the
14
category. Under section 26(c)(2), “category” treatment is warranted if chemicals are “similar in molecular
15
structure, in physical, chemical or biological properties, or in mode of entrance into the human body or into
16
the environment” or “in some other way are suitable for classification as such for purposes of this Act.”
17
19 33. Plaintiffs’ October 14, 2020 petition provides considerable background information on PFAS.
26 35. The EPA Action Plan for PFAS identifies numerous human exposure pathways for these chemicals,
27
28
9
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including: 1
1
2 • Drinking water from public water and private water systems, typically localized and associated
with a release from a specific facility (e.g., manufacturer, processor, landfill, wastewater treatment,
3 or facilities using PFAS-containing firefighting foams);
4 • Consumption of plants and meat from animals, including fish that have accumulated PFAS;
5 • Consumption of food that came into contact with PFAS-containing products (e.g., some
microwaveable popcorn bags and grease-resistant papers);
6
• Use of, living with, or otherwise being exposed to commercial household products and indoor dust
7 containing PFAS, including stain- and water-repellent textiles (including carpet, clothing and
8 footwear), nonstick products (e.g., cookware), polishes, waxes, paints, and cleaning products;
9 • Employment in a workplace that produces or uses PFAS, including chemical production facilities
or utilizing industries (e.g., chromium electroplating, electronics manufacturing, or oil recovery);
10 and
11 • In utero fetal exposure and early childhood exposure via breastmilk from mothers exposed to PFAS.
12 36. PFAS are often called “forever” chemicals because they do not break down or degrade over time
13 and therefore are highly persistent. Thus, they build up in the natural environment and in biological systems
14
if they are bioaccumulative. These characteristics, combined with the high mobility of many PFAS, have
15
resulted in their widespread distribution and pervasive presence both in environmental media and in people
16
and wildlife around the globe, including many remote locations. Thus, PFAS have been detected in the
17
blood of workers and the general population, with 99 percent of those sampled showing detectable levels
18
19 of these compounds.
20 37. This PFAS body burden is a function of multiple exposure pathways, including air emissions, food
21 and water consumption, consumer products like carpet or clothing and house dust. Because of their
22
resistance to degradation, there is no known safe method of disposal of PFAS that would prevent build-up
23
in the environment at the end of their useful lives.
24
38. In addition to their persistence, PFAS have high mobility, especially in water. Their high water
25
26 solubility and environmental persistence together make PFAS a ubiquitous pollutant of surface and
27
28
1
EPA’s Per- and Polyfluoroalkyl Substances (PFAS) Action Plan, February 2019.
10
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groundwater. As a result, PFAS-contaminated drinking water is a widespread threat across the US; a
1
growing number of drinking water suppliers have detected PFAS in source water or tap water, raising
2
3 concerns about drinking water safety and resulting in use of costly treatment systems in numerous
10 cancer, elevated cholesterol, liver disease, decreased fertility, thyroid problems and changes in hormone
11 levels and immune systems. Moreover, concurrent exposure to multiple PFAS may have additive or
12 synergistic effects.
13 40. To date, EPA has failed to use its testing authorities under TSCA section 4 to fill the extensive
14
data-gaps on PFAS.
15
CONTAMINATION OF THE CAPE FEAR RIVER BASIN BY THE CHEMOURS FACILITY
16
41. Plaintiffs’ petition also described in detail the operation of the Chemours’ facility in Fayetteville,
17
18 North Carolina and the PFAS contamination it has created in the Cape Fear River basin. Key highlights are
20 42. The Chemours plant is located on a 2,150-acre site in a rural area south of Fayetteville, adjacent to
21
the west bank of the Cape Fear River. The river continues for over 110 km to the City of Wilmington and
22
then broadens into an estuary that ultimately flows into the Atlantic Ocean. Residents of Wilmington and
23
other population centers downstream from the facility use the river as a source of drinking water. .
24
43. The facility was built and operated by DuPont and started producing fluoropolymers in 1971. In
25
26 2015, DuPont spun off its performance chemicals business to Chemours, a newly created company which
27 then acquired the Fayetteville plant and other former DuPont facilities.
28 44. The plant is a major producer and user of PFAS. Its PFAS-based product lines are
11
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Fluoromonomers, Fluorinated Vinyl Ethers and Nafion® Polymers, which are used as membranes in fuel
1
cells and chlorine production. The mix of precursors, byproducts, degradation products and commercial
2
3 substances associated with these product lines is complex and not well-understood but likely involves
4 hundreds if not thousands of individual PFAS, many of which have chemical structures that are as yet
5 unidentified.
6
45. A major source of concern has been Chemours’ production of “GenX” compounds. These
7
chemicals have been produced as byproducts at the Fayetteville since the early 1980s. They were recently
8
commercialized as a replacement for perfluorooctanoic acid (PFOA), a surfactant in the polymerization of
9
10 fluoropolymers that was phased out in 2015 in response to health and environmental concerns.
11 46. During monitoring by Strynar et al. and Sun et al., GenX and nine other PFAS were identified in
12 the Cape Fear River and drinking water downstream of the Fayetteville plant. 2 In further sampling of the
13 river downstream of the plant, McCord et al. (2019) found 37 unique PFAS molecules. 3 Several of these
14
compounds were also detected in the blood of residents of the Cape Fear region, confirming human
15
exposure. 4 Sampling in the Cape fear River indicated that total PFAS concentrations (all substances
16
combined) were 130,000 parts per trillion (ppt). 5 Sampling by water utilities subsequently identified
17
19 47. As concern increased about surface water and drinking water contamination, monitoring of other
20 environmental media for the presence of PFAS produced at the Fayetteville plant was initiated. As
21
22
2
Hopkins, Z. R., Sun, M., DeWitt, J. C. & Knappe, D. R. U. Recently Detected Drinking Water
23 Contaminants: GenX and Other Per- and Polyfluoroalkyl Ether Acids. Journal AWWA 110, 13-28,
doi:10.1002/awwa.1073 (2018).
24 3
McCord, J. & Strynar, M. Identification of Per- and Polyfluoroalkyl Substances in the Cape Fear River
by High Resolution Mass Spectrometry and Nontargeted Screening. Environmental Science & Technology
25 53, 4717-4727, doi:10.1021/acs.est.8b06017 (2019).
4
Kotlarz, N. et al. Measurement of Novel, Drinking Water-Associated PFAS in Blood from Adults and
26 Children in Wilmington, North Carolina. Environmental Health Perspectives 128, 077005,
doi:doi:10.1289/EHP6837 (2020).
27 5
Zhang, C., Hopkins, Z. R., McCord, J., Strynar, M. J. & Knappe, D. R. U. Fate of Per- and Polyfluoroalkyl
Ether Acids in the Total Oxidizable Precursor Assay and Implications for the Analysis of Impacted Water.
28 Environ Sci Technol Lett 6, 662-668, i:10.1021/acs.estlett.9b00525 (2019).
12
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determined in Chemours’ compliance testing under a North Carolina consent order, several additional
1
PFAS associated with the Fayetteville Works facility have been detected in private wells, wastewater,
2
3 stormwater, sediment, groundwater, soil, air emissions, and local produce, including a large number of
10 Sampling of drinking water systems and private wells since the order was issued documents the continuing
18 maintained that the 54 PFAS meet TSCA criteria for testing because (1) data on their effects are insufficient
19 or unavailable and (2) they may present unreasonable risks by virtue of the combination of potential
26 51. The petition maintained that, since EPA and other authorities have recognized that all PFAS have
27 the potential for causing the adverse health and environmental effects linked to well-characterized
28 substances in the class, there is a strong basis to conclude that the 54 PFAS “may present an unreasonable
13
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COMPLAINT .
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risk of injury” under TSCA section 4(a)(1)(A). According to the petition. this potential risk is magnified
1
by the co-occurrence of multiple PFAS in drinking and surface water, other environmental media and the
2
3 blood of humans and wildlife in the Cape Fear watershed. Where exposure is to multiple PFAS
4 simultaneously, the petition emphasized, their toxic effects may be additive or synergistic, resulting in
5 greater overall risk than exposure to any individual PFAS alone.
6
52. The petition also maintained that the “sufficiency” of available information on the 54 PFAS should
7
be determined by comparing available data with the known adverse effects of other PFAS. According to
8
the petition, if a scientifically sound assessment of each of the 54 chemicals for these critical toxic
9
10 endpoints cannot be conducted because of the lack of data, available information on these substances
12 53. The petition then showed that the 54 substances lack any health and ecological effects data or the
13 available studies are limited and incomplete and do not provide an adequate basis for hazard and risk
14
assessment. Key data gaps include measurement of physical-chemical properties, methods of analysis,
15
assessment of partitioning, bioaccumulation, and degradation, pharmacokinetics, and toxicity, especially
16
for the endpoints commonly observed for the better studied PFAS, such as liver toxicity, and effects on the
17
18 immune system, lipid metabolism, kidney, thyroid, development, reproduction, and cancer. In addition,
19 despite their widespread detection in environmental media, ecotoxicity data are generally lacking.
20 54. Based on its showings of potential unreasonable risk and insufficiency of data, the petition
21
proposed the following testing program:
22
Experimental Animal Studies
23
• Compounds in both Tiers would undergo 28-day repeated dose rodent toxicology studies coupled
24 with reproductive and developmental toxicity screening assays, examining critical PFAS
endpoints including hormone disruption, liver and kidney damage, developmental and
25
reproductive harm, changes in serum lipid levels, and immune system toxicity.
26
• These studies would also be conducted on three mixtures of PFAS representative of the groups of
27 substances to which residents have been exposed through drinking water, human sera and other
pathways.
28
14
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COMPLAINT .
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3 • Most studies would be carried out in two species (mice and rats) and by oral routes of
administration, except inhalation would be used for volatile chemicals.
4
• Toxicokinetic studies would be conducted to characterize relationships between serum
5
concentrations and dermal, oral and inhalation exposures in the test species, and to evaluate
6 biological half-life and potential for bioaccumulation.
7 • Testing requirements would be based on EPA and OECD guidelines, with appropriate adjustments
to reflect sensitive endpoints that have been reported for PFOA, PFOS, and GenX.
8
9 Human Studies
10 • A human health study for the Cape Fear watershed would be conducted using a similar study
design to that used for the Parkersburg, WV PFOA (C8) study. The goal of the study would be to
11 determine the relationship between exposure to the mixtures of PFAS that characterize current
and historical exposure in the Cape Fear watershed and health outcomes among exposed
12 populations.
13
• Testing would also be performed to determine human half-lives of the listed chemicals through
14 longitudinal biomonitoring and exposure estimation in workers.
19 55. The petition proposed that, to maximize the credibility and objectivity of the data and key findings,
20 EPA contract with the National Academy of Sciences (NAS) to form an independent expert science panel
21 with responsibility for overseeing all aspects of the testing program. The public and Chemours would have
15
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COMPLAINT .
Case: 22-2287 Document: 35-3 Page: 43 Date Filed: 01/13/2023
57. The bulk of the petition denial (pp. 8-18) consists of a lengthy summary of the EPA PFAS Action
1
Plan and a detailed list of the various PFAS-related measures EPA has taken under the Plan and other
2
3 programs. This list of EPA accomplishments is irrelevant to the petition. These EPA actions do not speak
4 to whether the 54 PFAS in the petition meet the criteria for testing in section 4 of TSCA and provide no
5 basis for denying the petition.
6
58. The petition denial also asserts (p. 19) that “the petitioners have not provided the facts necessary
7
for the Agency to determine for each of the 54 PFAS that existing information and experience are
8
insufficient and testing of such substance or mixture with respect to such effects is necessary to develop
9
10 such information.”
11 59. However, before filing the petition, plaintiffs reviewed the available data for the 54 PFAS. As the
12 petition explains, some testing has been conducted or is underway on a small number of compounds but it
13 fails to provide necessary data for all-endpoints and most of the 54 PFAS have no health effects data at all.
14
60. In addition, EPA and many other expert bodies agree that there are fundamental data gaps for
15
nearly all PFAS. As underscored in EPA’s PFAS Action Plan, “[t]here are many PFAS of potential concern
16
to the public that may be found in the environment. Most of these PFAS lack sufficient toxicity data to
17
18 inform our understanding of the potential for adverse human or ecological effects.”
19 61. The petition denial (pp. 23-24) also ”finds that the petitioners failed to address ongoing testing and
20 data collection for some of the 54 PFAS, thereby failing to set forth facts that are necessary to establish
21
there is a need for the testing sought in the petition. This research may provide information that overlaps
22
with testing the petitioners requested, which would render the information unnecessary under TSCA section
23
4(a)(1)(A)(i)(III).”
24
62. However, nearly all the ongoing research cited by EPA consists of in vitro assays, including high-
25
26 throughput testing conducted by the EPA Office of Research and Development (ORD) to determine various
27 markers of bioactivity that might signal the potential for in vivo effects. The health effects testing proposed
28 in the petition consists of in vivo animal studies, epidemiological research and limited monitoring of
16
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COMPLAINT .
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workers. No in vitro assays are included. Non-animal test methods (New Approach Methods or NAMs)
1
cannot at this time provide a scientifically sufficient understanding of the health and environmental effects
2
3 of PFAS.
10 reconsideration request provided the results of a systematic and comprehensive literature search conducted
11 by petitioners’ scientific consultants on these substances. This search included EPA’s ChemView and
12 CompTox data-bases as well as Pub-Med and ECHA files. The search showed that the 54 PFAS lack most
13 or all of the studies proposed in plaintiffs’ petition.
14
FIRST CLAIM FOR RELIEF
15
65. Plaintiffs hereby incorporate by reference the allegations contained in paragraphs 1 through 64 as
16
if fully set forth herein.
17
18 66. TSCA section 21(b)(4)(A) provides a right to judicial review in an appropriate district court
19 within 60 days following denial of a petition to issue a rule or order requiring testing under TSCA section
20 4.
21
67. On October 14, 2020, plaintiffs petitioned defendant EPA under Section 21(a) of TSCA to require
22
health and environmental effects testing on 54 PFAS manufactured by Chemours at its chemical production
23
facility in Fayetteville, North Carolina, downstream of the communities that plaintiffs represent. The
24
petition sought issuance of a rule or order under section 4 of TSCA compelling Chemours to fund and
25
26 carry out this testing under the direction of a panel of independent scientists.
17
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COMPLAINT .
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69. Following the denial of a petition seeking the issuance of a rule or order under TSCA section 4,
1
section 21 provides that “the petitioner shall be provided an opportunity to have such petition considered
2
4 70. Section 21(b)(4)(B)(i) provides that, where the petition seeks issuance of a rule or order under
5 section 4, the district court shall “order the Administrator to initiate the action requested by the petitioner”
6
if it “demonstrates to the satisfaction of the court by a preponderance of the evidence” that “(I) information
7
available to the Administrator is insufficient to permit a reasoned evaluation of the health and
8
environmental effects of the chemical substance to be subject to such rule or order; and (II) in the absence
9
10 of such information, the substance may present an unreasonable risk to health or the environment . . . “ 15.
11 U.S.C. §2620(b)(4)(B)(i))I)-(II).
12 71. The preponderance of the evidence to be presented by plaintiffs demonstrates that the 54 PFAS
13 proposed for testing in their petition meet these standards for ordering EPA to issue a test rule or order
14
under section 4 TSCA.
15
72. The Court should thus direct EPA to initiate a proceeding for the issuance of a rule or order
16
requiring Chemours to carry out the studies on the 54 PFAS specified in plaintiffs’ petition.
17
19
73. Plaintiffs hereby incorporate by reference the allegations contained in paragraphs 1 through 64 as
20
if fully set forth herein.
21
74. Under section 706 of the APA, 5 U.S.C. § 706, a reviewing court shall “hold unlawful and set aside
22
agency action, findings, and conclusions found to be . . . . arbitrary, capricious, an abuse of discretion, or
23
otherwise not in accordance with law.”
24
75. Denials of petitions under TSCA section 21 are reviewable under these APA provisions as well as
25
under the de novo review provisions in section 21(b)(4)(B).
26
76. Defendants January 7, 2021 denial of plaintiffs’ petition was arbitrary and capricious, an abuse of
27
discretion and not in accordance with law.
28
77. The petition denial should be declared unlawful under the APA judicial review provisions.
18
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COMPLAINT .
Case: 22-2287 Document: 35-3 Page: 46 Date Filed: 01/13/2023
1 78. Under section 21(b)(4), if denial of a petition is set aside under the APA, the Court may order EPA
2 “to compel the Administrator to initiate a rulemaking proceeding as requested in the petition.”
3 79. The Court should thus direct EPA to initiate a proceeding for the issuance of a rule or order requiring
4 Chemours to carry out the studies on the 54 PFAS specified in plaintiffs’ petition.
6 WHEREFORE, plaintiffs respectfully request judgment in their favor and against defendants upon their
7 claims and, further, request that this Honorable Court enter judgment against defendants:
8 (1) Declaring that plaintiffs have demonstrated by a preponderance of the evidence that,
9 with respect to the 54 PFAS proposed for testing in their petition, “(I) information
11 health and environmental effects of the chemical substance to be subject to such rule or
12 order; and (II) in the absence of such information, the [PFAS]may present an
14 2620(b)(4)(B)(i);
15 (2) Declaring that defendants’ denial of plaintiffs’ petition was arbitrary, capricious, an
16 abuse of discretion, and otherwise not in accordance with law under 5 U.S.C. § 706;
17 (3) Ordering defendants to initiate a proceeding for the issuance of a rule or order under
18 TSCA section 4 requiring Chemours to conduct the studies on the 54 PFAS requested
20 (4) Awarding plaintiffs their costs of suit and reasonable fees for attorneys and expert
22 (5) Granting plaintiffs such further and additional relief as the Court may deem just and
23 proper.
1 ROBERT M. SUSSMAN
Sussman & Associates
2
3101 Garfield Street, NW
3 Washington, DC 20008
(202) 716-0118
4
Attorneys for Plaintiffs
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COMPLAINT .