12th RoC: Formaldehyde Causes Cancer

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On Friday the U.S. Dept. of Health and Human Services listed formaldehyde – a key ingredient in a popular family of metalworking fluid biocides – as a known human carcinogen.

Formaldehyde is listed as a known human carcinogen in the 12th Report on Carcinogens, or 12th RoC, a Congressionally mandated report prepared for HHS by the National Toxicology Program.

There is now sufficient evidence from studies in humans to show that individuals with higher measures of exposure to formaldehyde are at increased risk for certain types of rare cancers, including nasopharyngeal (the nasopharynx is the upper part of the throat behind the nose), sinonasal, as well as a specific cancer of the white blood cells known as myeloid leukemia, according to HHS.

Formaldehyde had been listed in the 2nd RoC through 11th RoC as a substance that was reasonably anticipated to be a human carcinogen.

Metalworking fluid formulators now face uncertainty over how the U.S. Environmental Protection Agency will regulate formaldehyde.

Formaldehyde-releasing chemistries are very cost-effective biocides and have been used for decades in metalworking fluids. The most common formaldehyde-donor chemistry is triazine, also known as hexahydrotriazine or HHT, but other formaldehyde condensates are also EPA-registered for use in the metalworking industry.

The 12th RoC has created a lot of confusion. You now have conflicting determinations, the National Academies of Sciences vs. NTP, Adrian Krygsman, director of product registration with Troy Corp. in Florham Park, N.J., told Lube Report. In April, the National Academies of Sciences issued a blistering review of EPAs assessment of the health effects of formaldehyde exposure.

The NAS review concluded that EPAs report needed significant revisions, but it found EPA had substantiated its conclusion that formaldehyde exposure can cause cancers of the nose, nasal cavity and upper throat. However, NAS concluded that blood cancers were not supported.

EPA must now decide how to respond both to the NAS review and 12th RoC listing. It could be weeks or months to know what EPA will do, Krygsman said. Anindustry meeting with EPA to address formaldehyde issues has already been scheduled for early fall.

Perceptions are also an issue. Perceptions will hurt, said Krygsman. In addition, the 12th RoC listing could have an impact in Europe, wherethe formaldehyde dossier submitted under the EUs REACH program couldcontribute to possible restrictions on formaldehyde use.

In addition to formaldehyde, seven other substances were added to the 12th RoC, which now includes 240 listings. It is available at http://ntp.niehs.nih.gov/go/roc12.

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