National Academy of Sciences Report Finds That EPA’s Formaldehyde Assessment Needs Revision

Last week, the National Academy of Sciences (NAS) concluded that the U.S. Environmental Protection Agency’s (EPA) draft health assessment of formaldehyde required “substantial revision.” The NAS disagreed with a number of the EPA’s key findings, including that formaldehyde causes leukemia, specific cancers of the respiratory tract and other noncancerous health effects, such as asthma. The report also provided recommendations for the EPA to revise its draft, including a “road map” for generally improving the agency’s risk assessment process. It is now up to EPA officials to decide how to address the NAS recommendations.

NFDA closely monitors domestic and international formaldehyde studies since the chemical is widely used in embalming products. Last year, after more than a decade of study, the EPA issued a draft risk assessment of formaldehyde, which was intended to update its Integrated Risk Information System (IRIS) with recent studies that assessed the health hazards posed by inhaling formaldehyde. Many of these studies have classified formaldehyde as a carcinogen; however, because of intense debate over whether inhaled formaldehyde poses a risk of nasopharyngeal cancer (back of the throat), leukemia or asthma, the EPA asked NAS to evaluate its draft IRIS assessment.

Key findings of the NAS report:

The EPA’s assessment was not prepared in a logically consistent fashion and did not document methods and criteria for selecting and evaluating the studies considered. This lack of clarity and transparency in the formaldehyde assessment has also been found in other EPA chemical assessments that the NAS reviewed. NAS recommended that the EPA change its risk assessment methodology.

Humans and animals produce formaldehyde as part of the normal metabolic process. Formaldehyde is typically present in all tissues, cells and bodily fluids. The naturally occurring presence of formaldehyde in the body complicates the evaluation of the health risks associated with formaldehyde inhalation.

The EPA correctly concluded that formaldehyde is genotoxic, meaning that it impacts cell DNA. Formaldehyde is absorbed in the body at the site of first contact, meaning that formaldehyde is likely to remain in the body in the respiratory cells that line the airways. Although the NAS could not find support that formaldehyde exposure impacts cells far from the point of inhalation, effects have been observed in highly exposed people.

The EPA mistakenly grouped all leukemias and lymphomas together, but not all such cancers are closely related. The EPA’s assessment properly concluded that formaldehyde can cause cancer in the nose, nasal cavity and back of throat (nasopharynx). The EPA’s conclusion that formaldehyde exposure caused leukemia and other forms of cancer was not adequately supported.

The full report can be found on the NAS website, http://nationalacademies.org/morenews/20110408b.html.

Recent Research and NFDA Education Efforts

In 2004, the International Agency for Research on Cancer (IARC), the leading international cancer agency, reclassified formaldehyde as a Group I carcinogen after finding a link between formaldehyde and nasal cancer. In 2009, IARC found sufficient evidence to conclude that formaldehyde exposure may cause leukemia, a disease of the blood and bone marrow.

Following a 20-year study of embalmers, the National Cancer Institute published a report in 2009 that found a link between embalming and death from myeloid leukemia, with the greatest risk found among those who practiced embalming for more than 20 years and who experienced great formaldehyde exposure in the preparation room. This study was not mentioned in the NAS report.

In 2010, an expert panel of the National Toxicology Program (NTP) concluded that formaldehyde should be listed as a known human carcinogen in its “12th Report on Carcinogens.” The NAS report noted, however, that some scientists disagree with the IARC and NTP conclusions and have published studies that raise questions about those findings. The NTP’s determination for formaldehyde has not yet been finalized.

In spite of a lack of conclusive evidence showing a definitive link between various forms of cancer and formaldehyde, NFDA has used these appraisals of the health hazards associated with formaldehyde to educate funeral professionals and provide guidance on reducing exposure to the chemical in the preparation room.

In 2009, NFDA issued its “Formaldehyde Best Management Practices,” which offer guidance on risk-reduction practices that funeral directors should adopt to lessen their exposure to formaldehyde and thus minimize associated health risks. The “Formaldehyde Best Management Practices” can be found on the NFDA website, www.nfda.org/additional-tools-embalming.

Last year, NFDA issued its groundbreaking ventilation study, which identified the features of a ventilation system that will effectively remove formaldehyde from the embalmer’s breathing zone and reduce risk of formaldehyde inhalation. Ventilation has been found to be the single most effective way to reduce formaldehyde vapor levels and thus control associated health risks. NFDA undertook this study because there were no consensus formaldehyde ventilation standards applicable to funeral homes. Information about the ventilation study can be found on the NFDA website, www.nfda.org/ventilation.

Funeral homes that carefully follow NFDA’s “Formaldehyde Best Management Practices” and the recommendations of the ventilation study can reduce formaldehyde exposure in the preparation room. Careful control of formaldehyde exposure in the preparation room continues to be the strong recommendation of NFDA for protecting the health and safety of embalmers.

NFDA will soon begin a comparison study of formaldehyde-free embalming products.