The EPA and How the NFDA Formaldehyde Exposure Study

Will Impact the Future of Service

Presenters: Lesley Witter, Jzyk Ennis, and Marisa Kreider

www.nfda.org

A gentle reminder

Video/audio recording
and photography
of workshops are
prohibited.

Are there any reporters

in the room?

Thank you for your

cooperation!

Welcome

• Welcome

• Expectations for today

• Why did we do the NFDA Formaldehyde Exposure Study?
• What we did
• What we discovered
• What the future holds

• Acknowledgments
 Why did we do the NFDA Formaldehyde Exposure Study?

The EPA is assessing the health and environmental risks of formaldehyde.

This may lead to a federal determination that the health risk to embalmers and others is
too high AND could result in the EPA taking action, including:

• establishing very low exposure standards

• enacting management restrictions
• setting standards that NFDA’s members must meet in order to embalm with
formaldehyde
• issuing violation notices and penalties should funeral directors not comply

Why did we do the NFDA Formaldehyde Exposure Study?

Toxic Substance Control Act of 1976

TSCA requires the EPA to periodically conduct risk assessments to determine

whether particular uses of chemicals present an unreasonable risk to human health
or the environment.

If the EPA finds that a particular use of a chemical presents an unreasonable risk
to health or the environment, the EPA must consider whether to require
management controls to minimize harm.

Why did we do the NFDA Formaldehyde Exposure Study?

Risk Evaluation Timeline

TSCA Risk Evaluation Timeline
12/20 - Formaldehyde designated high priority substance

12/21 - Public submission of formaldehyde comments, information and data

4/23 - EPA propose draft risk evaluation, followed by 60-day public comment period

6/23 - EPA issues final risk evaluation

6/24 - EPA proposes a draft risk management rule

11/24 - Presential and Congressional elections

6/25 - EPA issues final risk management rule

**Under certain conditions, risk management rule may be issued up to two years later than above (2027).
 Why did we do the NFDA Formaldehyde Exposure Study?

#1 Priority:
- Health and Safety

#2 Priority:
- Data

What We Did:
Background on Formaldehyde Use During Embalming

• Since early 1900s, formaldehyde has been the preferred preservative for human remains.
• The composition of the fluid is left to the discretion of the embalmer
• Arterial fluid, cavity fluid, other additives

• Once diluted, the typical formaldehyde concentration for arterial fluid ranges from 3-6%
• Literature reports a wide-range of task-length exposure concentrations based on relatively old
studies
• 0.03 to 20.89 ppm

We needed to know if this data was current with modern practice and fewer embalming's
due to cremation that is typical today.

What We Did: Study Protocols

• Funeral homes volunteered to have us come to their funeral homes and conduct the research in
their embalming rooms.
• While we tried to capture a wide scope of facilities, number of cases, etc., we had to focus on those
firms who self-selected into the research.
• All on-site hygienists (HSE) volunteered and went through an Embalming 101 course to understand
exactly what to expect to ensure all volunteers were comfortable with the subject matter.
• A standard case report and protocols were established to ensure consistency in data collection.
• HSE’s documented the physical room, chemicals used, concentrations, room ventilation rate, etc.
along with collecting of actual data.
• PPE and ventilation were used during embalmings per OSHA requirements
• Half-face respirator with multi-gas cartridge, Goggles, Disposable gown, Nitrile gloves, and Shoe covers
 What We Did: Formaldehyde Study Overview

• Sampling occurred from September 22nd – November 4th

• 30 total days spent on location
• 12 funeral homes* in 10 states
• Additional background samples collected at NFDA offices (n=3)
• 127 samples collected (including blanks)
• Samples collected over full shift
• Samples collected for duration of active embalming (task samples)
• Marisa will now go over the findings of the research which is the most important
part of today.

*One day of sampling conducted at a 13th funeral home

What we discovered: Sampling Results

Marisa: basic slides on results on study

We can discuss choices we made as a panel

1Background location is NFDA office

2Represents 37 embalmings

• Air concentrations in non-detect samples were assumed to be LOD/2

• Of full-shift and ONU samples, only 1 exceeds the OSHA PEL for formaldehyde of 0.75 ppm
• Average value is likely to be skewed high because the data set represents more embalmings
per day than the industry reported data (i.e., 0.98 embalmings per day observed in the study)

What we discovered: Sampling Results

• Used NFDA survey data to

estimate number of embalmings
per day for a typical embalmer

• Recall that our sampling data set

represented 0.98 embalmings
per day  Survey shows that
the typical number is closer to
0.24 embalmings per day

• Reconstructed daily exposure for

a range of work patterns
 What we discovered: Comparing Results to Literature

Hauptmann, et al. (2009) Our Dataset

• Measured Full Shift: 0.19

ppm
Full-Shift Concentrations • 8-hr TWA: 0.2 ppm
• Modeled 8-hr TWA: 0.04
ppm (0.004 – 0.66 ppm)

Task Concentrations • 0.31 to 8.72 ppm • 0.06 to 1.4 ppm

Embalming Frequency • 100 per year • 60 per year

What the future holds

• EPA will rely on published literature

to assess exposure to formaldehyde
for funeral service

• EPA will compare exposure

estimates to “safe” levels they
determine
• Not yet clear what those “safe”
levels will be

• Comparisons used to determine

potential risk to workers

What the future holds: Outcome Analysis

Outcome 1 Outcome 2

No •EPA determines no unreasonable

risk associated with funeral service Unreasonable • EPA determines some exposure
unreasonable •No further action expected for scenario results in unreasonable risk
Risk
risk that profession to funeral service

•EPA require risk management measures to

reduce risk
Risk •Restrictions on use
Management •Implementation of engineering controls
•Use of PPE
•Etc.
Thank you to our sponsor

2022 NFDA International Convention

Continuing Education Workshop Sponsor

www.nfda.org