August 31, 2010
National Center for Environmental Assessment
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20460
Re: EPA Draft Toxicological Review of Formaldehyde Inhalation Assessment
Docket ID No. EPA HQ ORD 2010 0396
Dear Ms. Clark:
The American Forest & Paper Association, American Home Furnishings Alliance,
American Institute of Timber Construction, American Plywood Association, American
Wood Council, Composite Panel Association, Hardwood Plywood and Veneer
Association, Kitchen Cabinet Manufacturers Association, Wood Machinery
Manufacturers of America and the Virginia Forest Products Association are pleased to
provide comment on the Draft Toxicological Review of Formaldehyde Inhalation
We strongly support the American Chemistry Council’s Formaldehyde Panel’s
submitted comments on the draft assessment. Those comments present in detail major
scientific and policy concerns, including the draft’s falling far short of meeting the Office
Management and Budget’s Information Quality Act guidelines as well as the agency’s
own specific guidelines. Among some of the serious deficiencies of the current draft
assessment is its failure to consider the best available science, failure to use a sound
weight-of-the evidence approach, and a lack of transparency and objectivity.
Our members are actively committed to protecting human health and the environment.
The industry supported the recently enacted legislation to establish national
formaldehyde emission standards for composite panel products based on California’s
standards. In fact, U.S. industry is already meeting those standards, which are the
toughest in the world.
However, we are troubled that a scientifically flawed formaldehyde assessment could
cause needless concern among users of formaldehyde-based wood products, as well
as unwarranted environmental concerns. Below, we highlight some of the important
scientific issues that are more fully addressed in the Panel’s comments.
2A) In its characterization of lymphohematopoietic cancers, EPA must conduct a more rigorous analysis of the science, and include the most recently published meta-analysis.
The draft assessment concludes that a causal association exists between formaldehyde
exposure and all leukemias and lymphohematopoietic cancer as a group, based on two
studies (Hauptmann et al. 2003; Beane-Freeman et al; 2009). As discussed in the
Panel’s comments, critical scientific issues have been raised with regard to the two
epidemiologic studies. For example:
• National Cancer Institute’s reliance without explanation on peak exposures as a
dose metric as opposed to more typical exposures used in epidemiologic studies.
• The absence of scientific consensus on any plausible mode of action by which
formaldehyde could conceivably cause these malignancies.
Adding to these concerns, the draft assessment relies on a single meta-analysis to
support the lymphohematopoietic malignancies. Not discussed or cited in the draft is
the recent meta-analysis by Bachand et al; 2010, which arrives at different outcomes
and conclusions than the single meta-analysis relied upon by EPA. The agency must
incorporate this new meta-analysis into its assessment. Moreover, the draft does not
consider the implications of approximately 1,000 missing deaths from the Hauptmann et
al; (2003) study recently revealed in the update by Beane-Freeman et al; (2009), and
discussed by Marsh et al; (2010). These issues require EPA’s careful scientific
attention.B) Nasopharyngeal Study Limitations Require Objective Evaluation.
The draft assessment does not adequately address issues surrounding the principle
study (Hauptmann et al; 2004) reporting elevated levels of nasopharyngeal cancer
(NPC). As pointed out by the National Research Council (NRC), the majority of the
NPC cases were at a single plant, and most of these cases were in workers with one
year or less employment at the plant. Moreover, two large cohort studies did not find
any excess NPC cases (Coggon et al; 2003; Pinkerton et al; 2004). And as noted in the
previous section on analysis of lymphohematopoietic malignancies, EPA must also
consider the implications for NPC analysis of the approximately 1,000 missing deaths
from the Hauptmann et al; (2004) study which remains uncorrected. The agency needs
to clearly and objectively address these deficiencies.C) Reference Concentration (RfC) for Sensory Irritation Should Be Based On Human Chamber Studies.
EPA has inappropriately based its RfC for sensory irritation on three mobile home
studies in lieu of much more reliable data from human chamber studies. Chamber
studies preclude confounding exposures, reduce or eliminate false positives, and
provide for accurate measure of exposure, in addition to other study advantages. EPA’s
reasons for rejecting controlled chamber studies are without sound scientific merit, and
need to be reexamined.D) Quantitative Cancer Assessment Needs Reality Check.
Notwithstanding some of the critical limitations of human studies relied upon, EPA
bases its quantitative cancer risk assessment on epidemiologic data for NPC, Hodgkins
lymphoma and leukemia combined. The derived overall upper bound unit risk estimate
for full lifetime exposure is 0.13 per parts per million (1.1 x 10–4 per ug/m3). This
estimate also assumes a linear non-threshold mode of action for formaldehyde despite
considerable data to the contrary. The upshot is that the unit risk estimate stretches
biologic credulity. Based on the estimate, the exposure levels corresponding to a risk
range of 10-4 – 10-6 often used for risk management decisions are 1 part per billion (ppb)
to 0.01 ppb. Consider that formaldehyde occurs naturally in human breath at an upper
level of approximately 2 ppb. Reliance on questionable epidemiologic data and policy
rather than scientifically driven judgments lead to this unrealistic result.
We appreciate the opportunity to comment on the current draft formaldehyde
assessment document. If you have any questions, please contact Paul Noe at (202)
463-2777 or firstname.lastname@example.org.
American Forest & Paper Association
American Home Furnishings Alliance
American Institute of Timber Construction
American Plywood Association
American Wood Council
Composite Panel Association
Hardwood Plywood and Veneer Association
Kitchen Cabinet Manufacturers Association
Wood Machinery Manufacturers of America
Virginia Forest Products Association
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