SANITIZED

December 23, 2019
Via CDX
Mr. Greg Schweer, Chief
New Chemicals Management Branch
Chemical Control Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Re:

[
]
15-Day Notice Under 40 C.F.R. § 723.50(i)

Dear Mr. Schweer:
This submission is intended to share certain data and information recently received by
[
]regarding the following two proprietary chemical substances that [
] under Low Volume Exemptions (“LVEs”):


[



]

LVE Substance Background
The two referenced chemical substances (“LVE Substances”) are not manufactured in the
U.S. and are not sold in the U.S. as commercial chemical products. Rather, the LVE Substances
are imported by [
] for use in various industries including automotive, aerospace
and electronics. The LVE Substances are manufactured [
]. The LVE Substances are
important to manufacturing operations [
].
Additional Information
On December 2, 2019, [
] employees received preliminary human biomonitoringrelated information from [
] pertaining to blood analyses performed on [
] plant
1
employees. At the same time, [
] employees obtained information concerning estimates of
the half-lives of the respective LVE Substances in blood of those employees. The biomonitoring
information indicates that the [
] has analyzed worker blood samples for PFOA dating back
to 2004 and, in 2011, the plant expanded the biomonitoring program to include the LVE
Substances. Depending on their tenure and job responsibilities, some workers in the study have
1

At a certain point the biomonitoring program was expanded to include employees at a [
The results described in this letter refer to data from both the [
] and that R&D facility.

].

 Mr. Greg Schweer
RE: L-99-284 and L-02-017
December 23, 2019
Page 2

PRIVILEGED AND CONFIDENTIAL DRAFT

the potential to be exposed to each of the substances addressed by the biomonitoring program.2
The LVE Substances are both manufactured and used at the [
]. This is unlike operations in
the U.S. where the LVE Substances are only used, and only in TSCA-limited volumes. We
understand that the [
] has used this biomonitoring program to assesses the effectiveness
of – and continuously improve – its industrial hygiene-related engineering controls,
administrative controls and workplace personal protective equipment.
In 2004 [
] began collaborating with the [
] for this biomonitoring
program. Through this collaboration, blood samples were analyzed not only for PFOA and the
additional substances, but also for various hematological/clinical chemistry blood parameters,
i.e., hematology (Ht, Hb, WBC, RBC, PLTS); liver (albumin, globulins, bilirubin, AST, ALT,
ALP, GT); renal (blood urea nitrogen, creatinine, uric acid); pancreas function (amylase); lipid
metabolism (cholesterol, triglycerides, Apo-A and Apo-B lipoproteins); hormonal function
(TSH, FT3, FT4, testosterone, estradiol, PSA); glucose; and C Reactive Protein (CRP).3 The [
] plant also has been providing the [
] with work history (i.e., date of hire,
departments/jobs, dates of changes) and demographic information (i.e., gender, age, BMI,
smoking, alcohol consumption and use of medications) on monitoring subjects.
We understand that the [
] has been using the blood analyses, the work history
and demographic information to perform statistical analyses, on an ongoing basis, with reference
to the following objectives: (1) identify trends in blood concentrations of the monitored
perfluoro compounds produced at the [
] facility; and (2) identify any statistical
correlation between blood levels of each substance with the monitored blood parameters. As to
the LVE Substances, the monitoring and statistical analyses – which are ongoing at this time –
currently report or suggest the following:4
 All analyses for the period 2011-2019 confirm substantial decreasing levels of LVE
Substances in the blood of [
] plant workers. See attached data tables (Attachment 1).
 Positive statistical associations between the LVE Substances’ level in the blood of [
]
plant workers and serum lipids, ALT, γGT, and apoliporotein B; however, when adjusted for
PFOA, these associations were not apparent, which points to PFOA as a confounding factor.

2

We understand that the blood analyses used in the program do not (and cannot) differentiate between
the two LVE Substances. Accordingly, if both LVE Substances are present in a blood sample, the
reported value in the information necessarily reflects a total of the two LVE Substances in the sample.
In addition to PFOA and the LVE Substances, the biomonitoring program and results also include
] known as [
] That product is not
another analyte manufactured at the [
manufactured or distributed in the U.S. as a commercial chemical product.

3

Blood samples were analyzed for the LVE Substances and PFOA by the [
hematological parameters were analyzed for by the [
].

4

The preliminary information on the biomonitoring program obtained remains in draft form and
incomplete.

]. The

 Mr. Greg Schweer
RE: L-99-284 and L-02-017
December 23, 2019
Page 3

PRIVILEGED AND CONFIDENTIAL DRAFT

 Positive statistical associations between the LVE Substances’ level in the blood and
triglycerides albumin, albumin/globulin ratio, and FT3, and negative statistical associations
for alpha-2-globulins, IgG, IgM, and estradiol.
 Potential positive statistical associations also were noted for TSH and PSA; however, the
researchers reported that these associations were based on relatively few measurements and
were therefore considered to be less reliable.
In addition, [
] has informed us that they estimate the half-life of the LVE Substances in
the blood of monitored workers to be approximately 2.5-3 years.
[
] has informed us that the [
] researchers have concluded that none of
these results raise concerns from a clinico-toxicological point of view, and that the overall results
are not indicative of any pathological effects. We understand that [
] concludes from
these preliminary results and analyses that the workplace industrial hygiene controls that it has
used and improved during the relevant time frame are effectively serving their intended purpose
to reduce potential workplace exposures to the monitored substances. Although the [
]
only uses the LVE Substances and, unlike the [
], does not manufacture them, we
understand that the workplace industrial hygiene controls used at the [
] facility are
comparable to those used at like operations at [
].
We understand that EPA would wish to be timely informed of this additional information
and data under TSCA. We assume that EPA’s LVE program office would have the principal
interest in receiving and understanding this new information. Therefore, we are sharing this new
information now and within the LVE program’s 15 working day time frame, even though we do
not view it as qualifying under 40 C.F.R. § 723.50(i), given the apparent lack of any significant
acute or chronic health or environmental effects.
We would be pleased to meet with the Agency to provide further details and answer any
questions.
Sincerely,

[
By:
[
Attachment
4846-0901-2143, v. 1

]
]

 ATTACHMENT 1
LVEs L-99-284 and L-02-017
Data tables from the [
] biomonitoring survey which report blood serum level trends of the LVE
Substances L-99-284 and L-02-017 (all in mg/L= ug/mL) in workers at the identified plants (tables
renumbered). We understand that the data was approximately log-normally distributed and therefore
were loge transformed to approach Gaussian distributions.
KEY:
[
]: Refers to analytes representing a total concentration of both the [
] substances (if
both present). We understand that the blood serum analyses used in the biomonitoring program do
not (and cannot) differentiate between these two LVE substances.
ITSM: Refers to the [

] plant.

ITBL: Refers to the [

].
****

Table 1: [
Plant

] blood levels (all measurements), 2011-2019.
2011

ITSM

N
Min
Median
Mean
Max
ITBL
N
Min
Median
Mean
Max

65
123
0.007 0.014
0.434 0.380
0.821 0.872
4.690 9.540
0
0

Table 2: [
years.
Plant
ITSM

ITBL

2012

n
Min
Median
Mean
Max
n
Min
Median
Mean
Max

2013
264
0.008
0.458
1.169
14.386
63
0.003
0.083
0.259
2.213

2014

2015

2016

2017

2018

2019

407
443
242
365
390
408
0.003 0.003 0.003 0.003 0.003 0.003
0.203 0.177 0.456 0.228 0.150 0.136
0.481 0.478 0.751 0.548 0.412 0.343
4.632 8.485 5.485 6.563 6.842 3.822
114
134
46
57
59
77
0.003 0.003 0.003 0.003 0.003 0.003
0.037 0.020 0.110 0.076 0.044 0.028
0.138 0.089 0.217 0.152 0.102 0.072
1.394 1.173 1.153 0.810 0.873 0.556

P-value for linear
decreasing trend
of mean log([ ]

<0.001

<0.001

] blood levels in workers having measurements in each of the last 2
2018

2019

368
0.003
0.160
0.428
6.842
56
0.003
0.043
0.103
0.873

366
0.003
0.149
0.360
3.822
58
0.003
0.037
0.080
0.556

P-value for linear
trend of mean
log([
])

<0.001

0.004

A-1

 Table 3: [
years.
Plant
ITSM

ITBL

n
Min
Median
Mean
Max
n
Min
Median
Mean
Max

Table 4: [
years.
Plant
ITSM

ITBL

n
Min
Median
Mean
Max
n
Min
Median
Mean
Max

Table 5: [
years.
Plant
ITSM

ITBL

N
Min
Median
Mean
Max
N
Min
Median
Mean
Max

] blood levels in workers having measurements in each of the last 3
2017

2018

2019

323
0.003
0.243
0.561
6.563
50
0.003
0.078
0.150
0.810

323
0.003
0.174
0.444
6.842
50
0.003
0.061
0.115
0.873

322
0.003
0.153
0.371
3.822
51
0.003
0.053
0.091
0.556

P-value for linear
trend of mean
log([
])

<0.001

<0.001

] blood levels in workers having measurements in each of the last 4
2016

2017

2018

2019

187
0.003
0.481
0.736
4.515
41
0.003
0.108
0.205
1.027

187
0.003
0.476
0.802
6.563
41
0.003
0.096
0.175
0.810

187
0.003
0.346
0.628
6.842
41
0.003
0.070
0.134
0.873

186
0.003
0.317
0.522
3.550
42
0.003
0.056
0.105
0.556

P-value for linear
trend of mean
log([
])

<0.001

<0.001

] blood levels in workers having measurements in each of the last 5
2015

2016

2017

2018

2019

175
0.003
0.556
0.804
8.485
39
0.003
0.111
0.237
1.173

174
0.003
0.503
0.774
4.515
40
0.003
0.110
0.208
1.027

174
0.003
0.504
0.843
6.563
40
0.003
0.097
0.177
0.810

174
0.003
0.370
0.663
6.842
40
0.003
0.069
0.135
0.873

173
0.003
0.336
0.549
3.550
41
0.003
0.057
0.107
0.556

P-value for linear
trend of mean
log[
]

<0.001

<0.001

 Table 6: [
years.
Plant
ITSM

ITBL

N
Min
Median
Mean
Max
N
Min
Median
Mean
Max

] blood levels in workers having measurements in each of the last 6
2014

2015

2016

2017

2018

2019

162
0.003
0.613
0.832
4.632
36
0.009
0.171
0.295
1.394

162
0.003
0.542
0.789
8.485
36
0.016
0.120
0.248
1.173

162
0.003
0.499
0.748
4.515
36
0.012
0.130
0.220
1.027

162
0.009
0.488
0.812
6.563
36
0.003
0.098
0.187
0.810

162
0.003
0.352
0.641
6.842
36
0.003
0.072
0.145
0.873

161
0.003
0.321
0.530
3.550
37
0.003
0.064
0.114
0.556

****
4846-0901-2143, v. 1

P-value for linear
trend of mean
log([
])

<0.001

<0.001