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Formaldehyde Exposure Monitoring: What You Should Know

Formaldehyde is very commonly used in research labs in the biotech and pharmaceutical industries often to fix tissues and cells. It’s typically used as an aqueous solution known as formalin, which contains 37% formaldehyde. Formalin is often used as a 10% solution that contains about 4% formaldehyde. Solutions of paraformaldehyde, which is a white crystalline powder of polymerized formaldehyde, are also frequently used.

Formaldehyde is a skin sensitizer and can cause eye and skin burns. It’s listed as a human carcinogen by the International Agency for Research on Cancer (IARC). It may also cause adverse reproductive effects and liver and kidney damage. In addition to the health risks associated with formaldehyde, formaldehyde solutions in methanol are combustible with a flashpoint of 122ºF for 37% formaldehyde (containing 15% methanol).

Regulatory requirements

There are two standards that address the use of formaldehyde in laboratories. The Formaldehyde Standard covers the use of formaldehyde in production laboratories such as histology, pathology, and human or animal anatomy labs. However, in labs where the Laboratory Standard applies, i.e., in non-production labs such as typical research laboratories, only certain requirements of the Formaldehyde Standard apply.

The Laboratory Standard supersedes most all requirements of the Formaldehyde Standard except for the requirement to ensure that employee exposures comply with the exposure limits set forth in the Formaldehyde Standard which are:

  • 8-hour time-weighted average (TWA) permissible exposure limit (PEL) of 0.75 parts per million (ppm)
  • 15-minute short-term exposure limit (STEL) of 2 ppm
  • Action level of 0.5 ppm

Additionally, in non-production labs where the action level for formaldehyde is exceeded, the exposure monitoring and medical surveillance requirements of the Formaldehyde Standard apply.

What operations require that exposure monitoring be conducted?

All organizations that have processes that may expose employees to formaldehyde should conduct an assessment of potential employee exposure and evaluate the need for exposure monitoring.  For most laboratory operations with formaldehyde/formaldehyde solutions that are conducted in a properly functioning fume hood, exposure monitoring is not specifically required, but baseline exposure monitoring is still recommended per the “objective data” requirements of the standard.  However, when it’s necessary to conduct work outside of a fume hood, exposure monitoring must be conducted to ensure users are properly protected.

Although exposure monitoring results may be below OSHA’s established regulatory limits, results may exceed the stricter NIOSH (TWA of 0.016 ppm and STEL of 0.1 ppm) and ACGIH (TWA of 0.1 ppm and STEL of 0.3 ppm) recommended exposure limits. In this case, additional engineering and/or other controls would be recommended to reduce exposure.

For additional information on formaldehyde exposure monitoring or for assistance with conducting monitoring at your facility, please email info@safetypartnersinc.com.

This blog was written by Beth Graham, our Associate Director of Quality, Research, and Training who has been with Safety Partners for the last 11 years.

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