DEQ-CFW_00074716

west virginia department of emkonmsYd protection
office of Environmental Remediation
131A Peninsula street
Wheeling, WV 26003
Phone. [phone]o/l= 304-238-1006
MEMORANDUM
To: Yogesh Patel
Matthew Sweeney
From: Lawrence P. Sirinek, Ph.D. 11-V
Date: January 31, 2012 '
Subject: DuPont GrenX Toxicity
CC: Fat Campbell
Scott Mandirola
Ken ,Ellison
Don Martin
Earl Ray Tomblin, Governor
Randy C. Huftum, Cabinet Secretary
www.dep.wv.gov -
I have completed my review of the documentation provided by DuPont regarding the toxicity of
GenX Compound A and Compound B. As I requested redacted documents, the identities and
chemical differences between the substances were not provided; however, most of the
toxicological studies appear to involve compound B. For this reason I have focused my.
discussion on this compound. The relevance of the different compounds as they relate to
permitted discharges should be clarified with. DuPont
With regard to ecological endpoints, I concur with the points provided in the documents
provided by DuPont. Thus, 4.2 mg/L, reported as the 21 day NOEC (no observed effect
concentration) for Daphnia magna seems to be an appropriate endpoint for use in determining
discharge levels that would protect aquatic receptors.
With regard to human health effects, there were no data from chronic studies performed in either
rats or primates contained in the material provided by DuPont Chronic studies in both rats and
mice are apparently ongoing, however data was not provided. While these data would be '
preferable, derivation of an appropriate toxicity criterion for human health can be based on a
subchronic (90 day) study performed in rats. Inn:this particular study, DuPont indicates a
NOAEL (no observed adverse effect level) at -10 mg/kg/day, based on evidence of regenerative
anemia in males at 100 mg/kg/d and females at 1000 mg/kg/d. Other effects were reported, but
are likely attributable to mechanisms that are often considered irrelevant to potential human
toxicity (e.g. PPARa agonists). .
With'regard to the NOAEL, it must be noted that male rats exposed at this concentration (10
mg/kgiday) did exhibit significant decreases in erythrocyte (red blood cell) counts, hematocrit,
and hemoglobin levels that are also indicative of anemia. DuPont considers the anemia
Promoting a healthy environment.
DEQ-CFW 00074716

DuPont OenX Review
January 31, 2012
Page 2
described by these parameters as non adverse in this group, since the animals lacked evidence of
compensatory erythrocyte production (e.g. elevated reticulocyte counts). On the other hand,
while the reticulocyte counts were not significantly elevated in this group, there was a clear,
dose -dependent trend in the mean reticulocyte count at week 13. Unfortunately it cannot be
determined. w ether continued dosing beyond this time point would have resulted in more
dramatic indications of a compensatory response, or whether the impact was sufficiently limited
at. the 10 mg/kgtday dose, such that no compensatory response was needed. Absent more
definitive data, the depressed red cell counts, hematocrit and hemoglobin levels should be
sufficient to constitute a health -protective endpoint*for purposes of assessing the potential
impacts from chronic exposure to the test compound Additional consideration should be made
when results of the chronic study are provided.
On the basis of a revised NOAEL of 0.1 mg/kg/day, and applying relevant uncertainty factors for
chronic to subchronic extrapolation (10) and rat to human extrapolation (10), the oral reference
dose (RfDo) = 0.001 mg/kg/day. Based upon this value, a reasonable risk -based drinking water
equivalent level (DWEL) assuming total intake of the substance from a contaminated source
would be 35µg/L. As discussed in subsequent communications, a source adjustment of 50%
could reasonably be applied to this value to allow for potential intake from other sources. Use of
this adjustment would result in a final DWEL of 18 µg/L.. Based upon the information provided
by DuPont, I believe this value would protect both human health and the environment.
I hope this discussion is helpful. Please contact me should you require fiuutkher discussion or
clarification.
DEQ-CFW 00074717

west vlrgido department of en0brimenid protection
Division of Water and Waste Management
60157* Street SE
Charleston,•WV 25304-2345
Telephone Number [phone]
Fax Number. [phone]
Mr. D. David Altman
15 E 8s'Street, Suite 200
Cincinnati, OH 45202.
Dear Mr. Altman:
Berl Ray Tomblin, Governor
Randy C. Huffinan, Cabinet Secretary
www.dep.wv.gov
January 31, 2012
'~_ 91 710& 2133 3939 2094 3051
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Re: WV/NPDES Permit No. WV0001279
Consent Order No. 7418 Comments
This correspondence is in response to your comment letter dated December 13, 2011
regarding draft Consent Order No. 7418 for WV/NPDES Permit No. WV0001279 issued to the
Dupont - Washington Works facility. Comments are summarized first in bold italics followed by
the agency's responses. .
L Comment: The order should not allow Dupont to discharge the new compound until all
of the treatment upgrades are completed
The existing treatment employed at the facility will provide treatment of the new
compound. The additional treatment proposed by the permittee will enhance treatment
and allow for less frequent change -outs of activated carbon from the existing carbon bed
system. Regardless of the treatment enhancements to be made by the permittee, the
effluent limitations for the new compound are effective immediately upon issuance of the
consent order and will be protective of the water quality standards and designated uses of
the Ohio River.
2. Continent: The order•shouldn't be issued without expkrining the new compound, its
effects on people and tho environments; ids toxicity, and how the DEP arrived at the
sV'e# levels and monitoring requirements for the new compound
The new compound (C3 Dimer Acid/Salt) is a new fluoropolymer compound that Dupont
is representing as an ultimate replacement for the existing fluoropolymer known as C8
(or PFOA, perfluorooctanoic acid). Dupont entered into a Toxic Substances Control Act
Promoting a healthy environment.
DEQ-CFW 00074718

W VINPDES Permit No. W V0001279
Consent Order No. 7418
Response to Comments
Page 2 of 3
Consent (TSCA) Consent Order with the U.S. EPA in January 2009 which granted
Dupont approval, under conditions set forth in the TSCA Consent Order, to manufacture,
process, and distribute the new compound The U.S. EPA TSCA Consent Order
prescribed certain requirements and toxicological studies regarding the new compound.
In 2011, Dupont provided toxicological data to the WV DEP as well as plans to begin
production of the new compound As noted, the U.S. EPA TSCA Consent Order
prescribes certain requirements on Dupont regarding the new compound and those
requirements are required to be achieved independent of Consent Order No. 7418 that is
proposed by the WV DEP. The WV DEP reviewed the toxicological information
provided by Dupont regarding the new compound Chronic studies which provide data
regarding long-term impacts are still being conducted by Dupont on the new compound
and are not yet complete. Although such long-term studies are preferable, toxicological
data from shorter -term (e.g. subchronic) studies may be used to determine a suitable
toxicity criterion, provided an additional safety factor is applied. Thus the agency
utilized subchronic (90 day) data developed by DuPont in support of its PMN submission
(subsequent to the 2009 TSCA Consent Order), incorporating appropriate
safety/uncertainty factors, in order to calculate a risk -based Drinking Water Equivalent
Level (DWEL) for the new compound As a courtesy, the agency has attached a memo
prepared by a WV DEP toxicologist which summarizes how the agency arrived at the
risk -based DWEL. As the requisite chronic studies are completed in the firture, the
agency will revisit and revise, as necessary, the value indicated in the WV DEP Consent
Order. However, based on the information provided and all other information available
at this time, the WV DEP has determined that the requirements imposed will be
protective of West Virginia's narrative water quality standards found in 47 CSR 2,
Section 3 of the West Virginia Legislative Rules.
3. Comment: The proposed Order appears to exceed WV DEP's authority for modg
adiubbiradvely extended permits.
As noted in the Consent Order, the permit cannot be currently modified because it has
been administratively extended. The agency is continuing to process the reissuance of
WV/NPDES Permit No. WV0001279, but does not expect the permit to be reissued in the
near future. Therefore, the agency processed this Consent Order as the best available
means to address upgrades at the facility and the production of the new compound.
A Comment: The proposed Order relies on Dupont's own interpretation of the 99%
efficiency requirement in the U.S. EPA TSCA Order without independent
Interpretation by WV DEP or coilirmadon by U.S. EPA,
Please note that the 99% efficiency requirement is not part of WV DEP's Consent Order
and was a requirement determined by the U.S. EPA. Its reference in the WV DEP
document was noted as a "Finding of Fact" in order to provide background information
regarding prior events. For this reason, the WV DEP cannot provide insight or
justification for the requirements. in the TSCA Order. Any questions regarding the TSCA
DEQ-CFW 00074719

WV/NPDES Permit No. WV0001279
Consent Order No. 7418
Response to Comments
Page 3 of 3
Order should be directed to the U.S. EPA. Please note that the requirements in Consent
Order No. 7418 are independent of the requirements in the TSCA Order, but also do not
supersede said requirements.
S. Comment- A pubfc hearing h requested
The agency received three (3) requests for a public hearing regarding the consent order.
Based on the limited comments received by the agency and resultant limited requests for
a public hearing, the agency has determined that a public hearing is not warranted.
The agency would like to thank you for taking the time to submit comments.
The Division of Water and Waste Management issued Consent Order No. 7418 on January
31, 2012. Thank you for your interest in this order.
S. lye
-45�
Scott G. andirola
Director
Encolsure
cc w/enclosure: U.S. EPA Region 3
Env. Inspector Supervisor
Env. Inspector.
Little Hocking Water Association, Inc.
3998 State Route 124
PO Box 188
Little Hocking, OH 45742
DEQ-CFW 00074720