Document YGpkvkK4MK9QgV16odBBegd30
Larry R. Zobel, MD MPH
3M Medical Department
StaTTVice President
and Medical Director
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3 M Certified Mail
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3M Center, Building 0220-06-W-08 St. Paul, MN 55144-1000 651 733 5181 Office 651 733 5152 Fax
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November 16, 2005
No CBI
Re: TSCA Section 8(e) Supplemental Submissions: Docket Nos. 8EHO-1180-373 and 8EHQ-1180-374
Dear Sir/Madam:
3M has previously submitted analytical results for serum measurements of various fluorochemicals. As a supplement to those submissions, 3M provides additional results as described below.
Two female fluorochemical plant workers provided 3M with serum samples for their children through their private physicians and requested that 3M analyze the samples. A total of three children were sampled, one time each. To the best of 3M's understanding, the children were approximately 8 months, ten months and two years of age at the time of sampling. At the time, the workers participated in 3M's occupational medical surveillance program for fluorochemicals. This program does not include children. The sampling was done at the request of the mothers.
Worker #1 had one child sampled, in the fall of 2000, when the child was about 10 months old. The mother's blood was sampled in the fall of 1998, and again in 2000, several months after the baby's birth, as part of the regularly scheduled occupational monitoring. Thus, the maternal levels are provided here to offer some context, but they do not represent immediate pre pregnancy, gestational, or immediate post-partum levels.
Worker # 2 has two children. Child A was also sampled in the fall of 2000, at approximately age 2. The sample from 2000 was re-analyzed with improved analytical techniques in 2002. Child B was about 8 months old when sampled in the fall of 2002. Maternal values are available from the fall of 1998, March 2000, and June 2002, and as with worker #1, are provided to offer general context.
Sampling results are shown in the tables below. For results below the Lower Limit of 3 Quantification (LLOQ) of the analytical method, the quantification limit for the chemicafn (where available) is shown in parenthesis.
89060000087
89060000087
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WORKER #1 CHILD (Approximately 10 months old when sample collected in Fall 2000)
ANALYTE Perfluorooctanesulfonate (PFOS) Perfluorooctanoate (PFOA) Perfluorohexanesulfonate (PFHS) N-ethyl perfluorooctanesulfonamidoacetate (PFOSAA) N-methyl perfluorooctanesulfonamidoacetate (M570) Perfluorooctanesulfonamide (PFOSA) Perfluorooctanesulfonamidoacetate (M556)
RESULTS (ppm) Less than LLOQ (0.040) 0.055 0.011 0.008 0.007 Less than LLOQ (0.001) Less than LLOQ (0.004)
WORKER#!
ANALYTE
RESULTS (ppm)
Perfluorooctanesulfonate (PFOS) Perfluorooctanoate (PFOA) Perfluorohexanesulfonate (PFHS) N-ethyl perfluorooctanesulfonamidoacetate (PFOSAA) N-methyl perfluorooctanesulfonamidoacetate (M570) Perfluorooctanesulfonamide (PFOSA) Perfluorooctanesulfonamidoacetate (M556)
Nov. 1998 Sample
March 2000 Sample
0.146
0.117
0.069
0.338
0.026
0.026
0.018
0.008
0.032
0.029
Below LLOQ
Below LLOQ (0.001)
0.004
0.013
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WORKER #2 CHILD A (Approximately 2 years old when sample collected in Fall 2000)
ANALYTE
RESULTS (ppm)
2000 Method
Perfluorooctanesulfonate (PFOS) Perfluorooctanoate (PFOA) Perfluorohexanesulfonate (PFHS) N-ethyl perfluorooctanesulfonamidoacetate (PFOSAA)
N-methyl perfluorooctanesulfonamidoacetate (M570) Perfluorooctanesulfonamide (PFOSA)
Perfluorooctanesulfonamidoacetate (M556)
0.171
0.195
0.064
Below LLOQ (0.006)
0.009
Below LLOQ (0.001)
0.008
Reanalysis of 2000 Sampling with 2002
Method 0.183 0.138 0.054 0.005
0.007 n/a
n/a
WORKER #2 CHILD B (Approximately 8 months old when sample collected in Fall 2002)
ANALYTE Perfluorooctanesulfonate (PFOS) Perfluorooctanoate (PFOA) Perfluorohexanesulfonate (PFHS) N-ethyl perfluorooctanesulfonamidoacetate (PFOSAA) N-methyl perfluorooctanesulfonamidoacetate (M570)
0.169 0.224 0.028 0.008 0.007
RESULTS (ppm)
Dcument ;*'rocessing Center (Mail Code 7407M) -Page 4
WORKER #2
ANALYTE
Perfluorooctanesulfonate (PFOS) Perfluorooctanoate (PFOA) Perfluorohexanesulfonate (PFHS) N-ethyl perfluorooctanesulfonamidoacetate (PFOSAA) N-methyl perfluorooctanesulfonamidoacetate (M570) Perfluorooctanesulfonamide (PFOSA) Perfluorooctanesulfonamido acetate (M556)
Nov. 1998 Sample
0.091 0.022 0.013 Below LLOQ
0.006
Below LLOQ
Below LLOQ
RESULTS (ppm)
M arch 2000 Sample [2002
reanalysis]
June 2002 Sample
0.161 [0.142]
0.090
0.082 [0.067)]
0.025
0.018 [0.015]
0.009
0.020 [0.015]
Below LLOQ (0.004)
0.057 [0.054]
Below LLOQ (0.057)
Below LLOQ (0.001) [n/a]
n/a
0.012 [n/a]
n/a
3M does not believe that these data meet the TSCA Section 8(e) "substantial risk" reporting threshold. In our view, these data are limited and provide no basis to draw any scientific conclusions. Nevertheless, 3M has decided to submit these data to the 8(e) docket, with the consent of the two workers, recognizing the ongoing work by U.S. EPA to assess fluorochemical exposure pathways and potential risks.
If you have any questions, please do not hesitate to contact Dr. Larry Zobel at (651) 733-5181.
Sincerely,
Larry Z o b e l, MD MPH Staff Vice President and Medical Director 3M Medical Department