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.

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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

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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 [email protected].

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