August 31, 2010


Rebecca Clark


Acting Director


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


Assessment.


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.


2

A) 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


3


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 paul_noe@afandpa.org.


Sincerely,


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

Have something to say? Share your thoughts with us in the comments below.