SC1F~NCE PUBLICATION STRATEGY
Publication of scientific and technical information on the FC issue should follow a strategic plan
so that key findings can be understood in the context of the published scientific literature. Under
this strategy, the science needed to evaluate the safety o£PFOS (i.e. the available occupational
and toxico!ogy studies) will be published -- or in press -- and thus available to be cited when the
publication on serum levels in the general population is published. This will allow the serum level
findings to be placed in an understandable, credible context which demonstrates that there is no
medical or scientific basis to attribute any adverse health effects to 3M products. In this strategy,
the analytical methodology will be published concurrently with the serum level findings.

The strategy is described as a series of steps with a timeline for each activity, The strategy begins
with a brief summary of the scientific and technical studies published or publically available:

Key Studies and Reports Available

Ubel, F.A., and others, "Health status of plant workers exposed to fluorochemicals - a preliminary
report," American Industrial Hygiene Association Journal, vol. 41, pages 584-589, 1980.
(Published study of 3M workers showing no ill health effects of occupational exposure to
fluorgchemieals.)
Gilliland, F.D. and Mandel, J.S., "Mortality among employees in a PFOA production plant,"
Journal of Occupational Medicine, vol. 35, pages 950-954, 1993 (Pubtished sludy of 3M
employees showing no increased mortality due to occupational exposure to PFOA.).
Gilliland, F.D. and Mandel, J.S., "Serum perfluorooctanoic acid and hepatic enzymes, lipoproteins
and cholesterol: a study of occupationally exposed men," American Journal of Industrial
Medicine, vol. 29, pages 560-568, 1996 (Published study of l15 3M employees showing no
toxicity to the liver due to occupational exposure to PFOA.).
Key B.D., and others, "Critical review: Fluorinated organics in the biosphere," Environmental
Science and Technology, vol. 3 I, pages 2445-2454, 1997. (PFOS is described as "important
commercially as a surfactant and as a precursor of other fluorinated surfactant3; "as "resistant
to biological attack, "and as an inhibitor of "gap junction intercellular communication (GJIC)
in rat liver epithelial cells cultured in vitro." The paper reports that "inhibition of GJIC has
been tmpficated in tumor promotion during carcinogenesis, teratogenesis and reproductive
dysfunction. ")

Reich, C., "Re: TSCA Section 8(e) -- Perfluorooctane Sulfonate -- Docket Numbers 8EHQ1180-373; 8EHQ-1180-374; 8EHQ-0381-0394," 3M letter to Office of Toxic Substances, United
States Environmental Protection Agency, May 15, 1998. (This document, which will soon

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become pub#cly available through the TSCA 8e Office, reports the presence of very low (part
per billion) levels of PFOS in blood sera samples for individuals with no known occupational
exposure to fluorochemicals.)

Olsen, G.W., "An epidemiologic investigation of reproductive hormones in men with occupational
exposure to peffluorooctanoic acid," Journal of Occupational and Environmentat Medicine, vol.
40, pages 614-622, 1998. (Stud)i" by 3M Medical Department showing no significant hormonal
changes in 191 men occupational exposed to PFOA.).
Reich, C., "Re: TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: N-Ethyl Perfluorooctyl
sulfonamido ethanol and Perfluorooctane Sulfonate, Docket Numbers 8EHQ-1180-373; 8EHQ1180-374; 8EHQ-0381-0394," 3 M letter to Office of Toxic Substances, United States
Environmental Protection Agency, September 14, 1998. (This document, which will become
publicly available through the TSCA 8e Office, reported that PFOS, when administered to
female rats at oral doses of 1.6 or 3.2 milligrams per kilogram body weight per day during
pregnancy, significantly reduced pup survival. PFOS also reduced the average gain in body
weight of the female rats during pregnancy, with the weight gain at the 3.2 milligrams per
kilogram dose of only 87% of the control (no PFOS) rats.)

Strategy for Publication of Key Studies
The PFOS worker study, prepared by Dr. JeffMandel and others in the 3M Medical
Department, is in final review before submission to an occupationally-focused medical
journal. (This paper will report no adverse biological health effects from exposure to
PFOS, based on medical monitoring of workers.) Comment: publication of this paper is
key to demonstrating there is no medical or scientific basis to attribute any adverse health
effects to exposure to PFOS.
Recommendations:
1) The journal should be selected on the basis of interest in the paper and ability to
ensure peer review as quickly as possible.
2) Target submission of the paper by December 15, 1998; acceptance for
publication within three months of submission.
3) With this plan, this key study could be cited as early as March 15, 1999.
PFOS mitochendria study, by Dr. Ken Wallace of the University of Minnesota School of
Medicine in Duluth, is being prepared for submission to a peer-reviewed science journal.
(Paper will demonstrate PFOS’s mechanism of action on energy metabolism in a test
tube (in vitro) system.) Comment: this paper will be useful for demonstrating a possible
mechanism of toxicity of PFOS. However, without the toxicology studies discussed
below, the findings are of limited utility for a safety assessment.

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Recommendations:
1) The journal should be selected on the basis of interest in the paper and ability to
ensure peer review in a timely manner.
2) Target: submission of the paper by March 1999; acceptance for publication
within six months of submission.
3) With this plan, this study could be cited by September 1999.
The PFOS teratology study, conducted by the 3M Toxicology Department, has been
completed. A manuscript of the results, possibly including blood level measurements,
could be prepared for publication or presentation at a science conference. (Paper will
demonstrate that exposure to high doses of PFOS to pregnant animats does not cause
birth defects in the offspring. The blood level mea~Ttrements will allow correlations
between doses administered in this study and blood levels in animals and humans.)
Comment: since the study reports largely negative findings (no birth defects), it may be
difficuk to publish even with the blood level measurements. Consideration should be
given to combining this study with the results of the 3M and pubfished subchronic toxicity
studies discussed below.
Recommendations:
1) Dr. Chris Wilkinson, a well respected toxicologist with Jellinek, Schwartz &
Connolly, Inc., in Washington, D.C., who has been briefed on the FC issue, should
be hired to review the study and provide a recommendation on publication of a
paper on the teratology study and blood level measurements.
2) Assuming that Dr. Wilkinson and the 3M Toxicology Department agree to
submit a paper on the teratology study, Dr. Wilkinson should draft the paper, make
final revisions based on 3M review and comments, and submit the paper for
publication in a peer reviewed toxicology journal.
3) Target: one month for the recommendation and decision on publication. If the
decision is made to proceed with publication, target is three months for completion
of the draft paper, one month for 3M review and comment, one month for final
revision and submission to a peer-reviewed toxicology journal and three months for
acceptance.
4) With this plan, the teratology study could be cited as early as August 1999.
PFOS subchronic toxicology studies, conducted by 3M or reported in the scientific
literature, could be summarized and a manuscript prepared for publication. (The paper
wouM review what is known about the toxicity of PFOSfrom animal studies, prior to
conduct ofthe current studies by 3M. )
Recommendations:
1) This paper should review, or at least cite, other published toxicity studies on
PFOS in addition to the subchronic studies, i.e. all of the published toxicity studies
discussed under "Summary of Toxicology Studies" in the "Current Summary"
document.

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2) Dr. Wilkinson should be hired to review the studies and draft a paper for
publication.
3) Target: six months for completion of the draft paper, one month for 3M review
and comment, one month for final revision and submission to a peer-reviewed
toxicology journal and three months for acceptance.
The analytical methods developed to allow specific detection of PFOS in serum levels with
a low part per billion detection limit should be written up for publication in a peer
reviewed analytical chemistry journal. ( This paper wouM need to contain data on PFOS
levels in serum to document the utility and accuracy of the analytical method)
Recommendations:
1) Dr. Wilkinson should be asked to recommend an analytical chemist to prepare a
paper for publication on the analytical methods.
2) Assuming that Dr. Wilkinson’s recommendation is acceptable to the Analytical
Department, the analytical chemist consultant should draft the paper with Dr.
Wilkinson’s assistance, make final revisions based on 3M review and comments, and
submit the paper for publication in a peer reviewed analytical chemistry journal.
3) Target: one month for the recommendation and decision on the consultant.
Once a decision is made on the consultant, the target is three months for completion
of the draft paper, one month for 3M review and comment, one month for final
revision and submission to a peer-reviewed toxicology journal and three to six
months for acceptance.
4) With this plan, the analytical study could be cited as early as August 1999.
Additional serum level data is needed to document blood levels of PFOS for publication of
a peer reviewed science publication. (Thispaper wouM document what is known about
PFOS levets in serum artd assess the safety of current exposure levels based on the
worker study [paper #1 above], and the toxicology studies [papers 2-4 above] that have
been completed. The paper wouM need to reference the analytical methods cited in
paper #5).
Recommendations:
1) A decisions should be made by the 3M Medical Department with the advise of
the Legal Department and the Core Team as to what additional data is needed and
a plan developed to generate the needed data.
2) The 3M Medical Department should supervise the collection of serum samples
with analysis of PFOS levds by the Analytical Department or a contract laboratory
approved by them.
3) Dr. Wilkinson should be hired to review the serum data and draft a paper for
publication.
4) Target: finalize plans by January 1, 1999, three months to collect samples and
analyze the data, three months for completion of the draft paper, one month for 3M
review and comment, one month for final revision and submission to a peer-

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reviewed toxicology journal and three months for acceptance.
5) With this plan, the serum study could be cited as early as November 1999.

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