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Human Health and the Environment

Human Health and the Environment

 

Environment

3M has contributed to a number of studies regarding the presence of PFOS and PFOA in the environment. Of particular interest is the impact from releases to the environment resulting from 3M’s historic manufacture of these materials. The company no longer manufactures either PFOS or PFOA.

3M’s most recent study of fish in Pool 2 of the Mississippi River in Minnesota indicates PFOS levels in fish are decreasing. A link to one of the studies of the data is available.

Reference: 3M Fish Data Study 2011 (PDF, 1.5 MB)

Human Health

PFOS and PFOA are extremely well-researched materials.  This research has been conducted by 3M and other scientists around the world. 

The extensive research to date shows no adverse human health effects resulting from exposure to PFOS or PFOA. This is supported by observational research involving thousands of 3M production employees.  That research was conducted by 3M and by the University of Minnesota under grants from 3M.

In all of our years of research we have not found any evidence of adverse health effects in our employees.  Over 25 years of medical surveillance of exposed employees failed to identify any health effects attributable to exposure to PFOA or PFOS. It is important to note that employees working directly with these materials in a manufacturing facility have much higher exposure than that found in the general population. These studies and medical surveillance results have been published in peer-reviewed scientific journals and shared with the EPA and with regulatory agencies in other countries.

A bibliography of these studies can be downloaded below.

Reference: 3M Employee Medical Studies (PDF, 26 KB)

In addition to research of the exposure of 3M’s production employees who worked closely with these materials, the company has studied the low level presence of these materials in the general population. In 2000, 3M conducted a study analyzing the presence of PFOS and PFOA in the general population of the United States. In 2005, 3M repeated the study. The levels of PFOS and PFOA have declined.

A bibliography of 3M’s published studies of general population exposure can be found in the PDF file:

Reference: 3M General Population Exposure (PDF, 13 KB)

In addition, Centers for Disease Control (CDC) researchers have now published data on the levels found in the general population, which closely parallel 3M's previously published data.

Reference: Calafat, A., Kuklenyik, Z., Reidy, J., Caudill, S., Tully, J. and Needham, L. "Serum Concentrations of 11 Polyfluoroalkyl Compounds in the U.S. Population: Data from the National Health and Nutrition Examination Survey (NHANES) 1999-2000," Environmental Science and Technology 41: 2237-2242 (2007).

Ongoing research involving residents in Ohio, with average blood serum values of PFOA greater than the U.S. general population, is being conducted by the University of Pennsylvania. This work is being funded by a grant from the National Institute of Health Environmental Sciences (NIEHS), Environmental Justice Program. NIEHS is part of the National Institute of Health. The study is led by Dr. Edward Emmett who is board certified in occupational medicine and toxicology. In 2006, Dr. Emmett published the study results (see www.cdc.gov/exposurereport/perfluorinated_compounds.htm for abstract) and found no relationship between blood levels of PFOA detected in residents and their cholesterol levels, thyroid function, kidney function, liver function or blood cell counts. The study also found there is no relationship between blood levels of PFOA and any liver disease or any thyroid condition. While indicating that more research is needed, the study noted that local cancer rates in the area of the study were not higher than cancer rates statewide (Ohio).

In Minnesota, the Department of Health has completed an analysis of cancer rates in Washington and Dakota counties. The published report said overall cancer rates in the two counties are very similar to the rest of the state. In addition, the rates and types of cancers that occurred within specific communities are on par with other communities in the Minneapolis/St. Paul area.

References:

MDH Cancer Study:
http://www.health.state.mn.us/news/pressrel/cancer060707.html

University of Pennsylvania:

Emmett, et al., Community Exposure to Perfluorooctanoate: Relationships Between Serum Levels and Certain Health Parameters, Journal of Occupational and Environmental Medicine 48(8):771 (August 2006);

Emmett, et al., Community Exposure to Perfluorooctanoate: Relationships Between Serum Concentrations and Exposure Sources, Journal of Occupational and Environmental Medicine 48(8):759 (August 2006).

Other online information: http://www.lhwc8study.org/index.htm

Analytical Research Advancements

One of 3M’s scientific contributions has been the development of analytical methods that enable researchers around the world to test for the presence of PFOS and PFOA in the parts per trillion.  A part per trillion is the equivalent of one penny in ten billion dollars.

Another 3M advancement allows scientists to test smaller samples. This is how the wide- spread presence of these materials was detected.

A bibliography of 3M’s contributions to analytical methods can be downloaded below.

Reference: 3M Analytical Chemistry Methods (PDF, 29 KB)

Laboratory Studies and Risk Assessments

Laboratory Studies

More than 1,500 laboratory studies have been performed by 3M and independent researchers on PFOA, PFOS, and related compounds. The company has shared this extensive research with the scientific community and government agencies throughout the world. In the U.S., 3M has supplied the EPA with almost 60,000 pages of 3M research. Many of these studies can be obtained from the EPA on CDs, and will soon be accessible on the EPA’s Web site.

A bibliography of 3M’s toxicology studies can be downloaded below.

Reference: 3M Studies - Toxicology (PDF, 22 KB)

Reference:  EPA OPPT Docket AR-226, and EPA Docket OPPT-2003-0012.

Note:  AR-226 is not yet available on-line, but content CD's are available by calling the docket office at (202) 566-0280 or emailing oppt.ncic@epa.gov

Although some adverse effects have been observed in laboratory animals, these effects occur at high doses when compared to human exposure. The objective of laboratory studies is to find out the biological effects of a chemical and how much of a dose it takes to produce the effects. The concept of dose is critical. An analogy is aspirin. At a common sense level, people understand that two tablets will stop a headache, while one tablet may not – and many more tablets may be harmful. With regard to PFOA, PFOS and related products the dose necessary to cause adverse effects in laboratory studies is many times higher than the levels of exposure in the general population. Also, not all effects in laboratory animals occur in humans or other species because of biological differences. Scientists who do this type of work consider these differences.

Regarding PFBA, the results of 3M-sponsored laboratory research shows the chemical clears from the body much faster than PFOA and has lower toxicity. Low levels of PFBA were found in some municipal and private wells in the East Metro area. All levels of this chemical are below state guidelines.

Reference: Frequently asked questions about PFBA (PDF, 50 KB)

The fact that extremely low levels of a substance can now be found in human blood, due in part to the evolution of analytical testing capabilities, is not necessarily an indication of effects. The U.S. Center for Disease Control says, “The measurement of an environmental chemical in a person’s blood or urine does not by itself mean that the chemical causes disease. Advances in analytical methods allow us to measure low levels of environmental chemicals in people, but separate studies of varying exposure levels and health effects are needed to determine which blood or urine levels result in disease.”

Reference:
CDC, Third National Report on Human Exposure to Environmental Chemicals, July 29, 2005, p. 4 http://www.cdc.gov/exposurereport/report.htm

Risk Assessments

Extensive employee monitoring and other research indicates that no adverse human health effects are attributable to PFOS or PFOA in humans. In addition, risk assessments based on the results of laboratory animal studies indicate large margins of safety for the levels of PFOS and PFOA found in the environment.

The EPA is working on a risk assessment of PFOA, and has issued its draft risk assessment. The EPA also submitted a series of scientific questions to a Review Panel of the EPA’s Science Advisory Board (SAB) for additional input. The science panel issued its final report May 30, 2006. The report can be found at this link:

Perfluorooctanoic Acid Human Health Risk Assessment Review Panel (PFOA Review Panel)

This report by the PFOA science panel is not a final action by the EPA. Both the EPA and the SAB indicated more study should be conducted, including analysis of research that was not available to the SAB while it was working on its PFOA report. The EPA has said:

“The SAB Panel's input will be extremely valuable as EPA continues to develop a full and comprehensive assessment of the risks associated with PFOA. In the year and a half since the draft assessment was submitted to the SAB Panel, a considerable amount of additional research has been initiated, and some has been completed. Some of this new research may impact the Panel's assessment of PFOA. For this reason, it is premature to draw any conclusions on the potential risks, including cancer, from PFOA until all of this new testing is complete and the data are integrated into the risk assessment. (emphasis added)

Source: http://www.epa.gov/opptintr/pfoa/pubs/pfoarisk.htm

As of the fall of 2009, there are no new developments regarding the EPA's promulgation of its risk assessment for PFOA.

Additional information about PFOS and PFOA can be found in the links to the following risk assessments:

Organisation for Economic Cooperation and Development (OECD) on PFOS:
http://www.oecd.org/document/

3M PFOS Risk Assessment,  “Environmental and Health Assessment Document for Perfluorooctane Sulfonate and its Salts,” dated August 20, 2003. This document includes a risk assessment for general population exposure, and is available in the EPA public docket at EPA Docket No. AR226-1486.  It can also be downloaded below:
3M PFOS Risk Assessment (2003) (PDF, 1679 KB)

3M has conducted a risk assessment for the general population exposed to PFOA and published it in a peer reviewed journal (Butenhoff, J.L., Gaylor, D.W., Moore, J.A., Olsen, G.W., Rodricks, J., Mandel, J.H. and Zobel, L.R. “Characterization of Risk for General Population Exposure to Perfluorooctanoate,” Regulatory Toxicology and Pharmacology, 39 (2004) 363-380, April 16, 2004).

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About PFOS and PFOA

PFOA, PFOS and PFOS-related products are man-made materials that have had many important and critical uses in our society. Examples include firefighting foams used to extinguish chemical, oil and aviation fires, critical components in military and civilian aircraft, and industrial fluids used to make computer components and other electronic devices. PFOA is also used in the manufacturing processes that create non-stick coatings for cookware. PFOS-related product uses included stain resistant treatments for carpets, fabrics and paper products.  

3M began manufacturing and using this chemistry in the 1950’s for various products including some sold under the Scotchgard™ brand. 3M was a principal manufacturer of PFOA and PFOS-related products until it decided to phase out the production of these compounds starting in 2000. Other companies around the world continue to manufacture PFOA and PFOS, and some companies manufacture similar materials that are believed to break down in the environment to PFOA.

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