Press Releases/Publications

Article in several newspapers.

Industry Position on May 2008 Publication by Cherry et al. on Male Infertility and Glycol Ether Exposure in OEM – Downstream User Communication

May 2008: Publication by Cherry et al. on Male Infertility and Glycol Ether Exposure in OEM – Industry Letter to the Editor

Glycol ethers and semen quality: a cross-sectional study among male workers in the Paris Municipality

EPA proposes delisting of ethylene glycol butyl ether (EGBE) as a hazardous air pollutant

1. Industry Position on May 2008 Publication by Cherry et al. on Male Infertility and Glycol Ether Exposure in OEM – Downstream User Communication

Recently an article was published in the scientific journal ‘Occupational and Environmental Medicine’ (OEM) claiming an association between male infertility and glycol ethers. The conclusions were based on an epidemiological case-contol study.

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2. May 2008: Publication by Cherry et al. on Male Infertility and Glycol Ether Exposure in OEM – Industry Letter to the Editor

This letter to the editor appeared in “OEM Online” on 2 July 2008.

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3. Glycol ethers and semen quality: a cross-sectional study among male workers in the Paris Municipality

L Multigner, E Ben Brik, I Arnaud, J M Haguenoer, P Jouannet, J Auger and F Eustache

Occup. Environ. Med. 2007;64;467-473; originally published online 1 Mar 2007; doi:10.1136/oem.2005.023952

Objectives: Apparent increases in human male reproductive disorders, including low sperm production, may have occurred because of increased chemical exposure. Various glycol ether-based solvents have pronounced adverse effects on sperm production and male fertility in laboratory animals. The authors investigated the effects of past and current exposure to glycol ether-containing products on semen quality and reproductive hormones among men employed by the Paris Municipality.

Methods: Between 2000 and 2001 the authors recruited 109 men who gave semen, blood and urine samples and underwent an andrological examination. Information on lifestyle, occupation, exposure and medical history was obtained by interview. According to their job and chemical products used during the period 1990–2000, men were classified as either occupationally exposed or non-exposed. Current exposure levels to glycol ethers at the time of the study were evaluated by biological monitoring of six urinary metabolites.

Results: Previous exposure to glycol ethers was associated with an increased risk for sperm concentration, for rapid progressive motility and for morphologically normal sperm below the World Health Organization semen reference values. No effect of previous glycol ether exposure on hormones levels was observed. By contrast, current glycol ether exposure levels were low and not correlated with either seminal quality or hormone levels.

Conclusions: This study suggests that most glycol ethers currently used do not impact on human semen characteristics. Those that were more prevalent from the 1960s until recently may have long lasting negative effects on human semen quality.

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4. EPA proposes delisting of ethylene glycol butyl ether (EGBE) as a hazardous air pollutant

EPA Proposes Delisting of Ethylene Glycol Butyl Ether (EGBE) as a Hazardous Air Pollutant

The Environmental Protection Agency (EPA) announced on November 5, 2003 that it would shortly be publishing in the Federal Register its proposal to delist ethylene glycol butyl ether (EGBE) from the Clean Air Act Amendments' (CAAA) list of Hazardous Air Pollutants (HAPs). An EPA decision to delist would mean that EGBE would no longer be subject to the CAAA's Maximum Achievable Control Technology (MACT) requirements, or its residual risk and other requirements. EPA will be receiving comments for 60 days after Federal Register publication and will hold a public hearing if requested.

The American Chemistry Council Ethylene Glycol Ethers Panel (ACC Panel) filed a petition in August 1997 showing why the available evidence indicated that EGBE should be delisted. EPA found the petition complete as of December 21, 1998, and sought comments on the petition on August 3, 1999 (64 Fed. Reg. 42125). All submitted comments supported the petition.

EPA is directed under the CAAA to delist HAPs if there are "adequate data on the health and environmental effects of the substance to determine that emissions, ambient concentrations, bioaccumulation or deposition of the substance may not reasonably be anticipated to cause any adverse effects to human health or adverse environmental effects," Section 112(b)(3)(C). The Federal Register proposal (available at http://www.epa.gov/airlinks/airlinks1.html) indicates the Agency has found the data on EGBE meets this standard.

EPA finds wide margins of safety ("Hazard Quotients") between estimated maximum exposures and lowest toxicity effect levels. Specifically, EPA states maximum human exposures will be 16 to 50 times lower than the lowest level expected to pose any risk to human health. Thus, EPA concludes: "[W]e judge that the potential for human health and environmental effects [from EGBE] is sufficiently low to provide reasonable assurance that such adverse effects will not occur."

EPA also notes that exposure estimates were "at least a factor of 2" higher than what the Agency expects would be the maximum individual exposure and "at least an order of magnitude" less than the Agency's Reference Concentration (RfC) (the level below which the Agency does not expect any adverse health effects).

EPA also reviewed the numerous toxicity studies of EGBE. The proposal includes extensive Agency scientific interpretation of all the toxicity studies (including lifetime animal studies that investigated chronic effects including cancer). The Agency finds these data fully support its RfC for EGBE issued in 1999. EPA includes in the proposal it's most recent interpretation of the NTP study of cancer in mice and rats and concludes that extensive data show that its 1999 RfC is "sufficient" to prevent any cancer risk to humans."

November 2003

This information is brought to you by the member companies of the American Chemistry Council CHEMSTAR Ethylene Glycol Ethers Panel: The Dow Chemical Company, Eastman Chemical Company, Equistar Chemicals, LP, and Shell Chemical Company. For more information, please call your supplier representative, or Dr. Susan A. Lewis, Manager of the EGE Panel at (703) 741-5635 or by E-Mail: Susan_Lewis@americanchemistry.com.

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