americanchemistry.com®

 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 

February 22, 2011

VIA E- MAIL

EPA Docket Center

EPA West (Air Docket)

Attention Docket ID No. EPA-HQ-OAR-2010-0786

U.S. Environmental Protection Agency

Mailcode 2822T

1200 Pennsylvania Ave., NW

Washington, DC 20460

Re: Comments of the American Chemistry Council’s Formaldehyde Panel on the National 

Emission Standards for Wood Furniture Manufacturing Operations; Proposed Rule.

To Whom It May Concern: 

The American Chemistry Council’s Formaldehyde Panel (ACC) appreciates this opportunity to 

comment on the U.S. Environmental Protection Agency’s proposed rule for the National 

Emission Standards for Wood Furniture Manufacturing Operations (Proposed Rule). ACC 

strives to ensure appropriate product stewardship of chemicals, and as part of its mission, 

addresses important science and public policy issues related to formaldehyde chemistry, 

including proposed rulemaking and characterization of formaldehyde risk.

As set forth in these comments, EPA has failed to comport with the explicit Information Quality 

Act (IQA) Guidelines. The information that serves as a basis for the Proposed Rule is 

“influential” scientific risk assessment information and therefore must adhere to a rigorous 

standard of quality. Despite the requirements of the IQA Guidelines, EPA has failed to support 

key conclusions in the Proposed Rule with the best available science. By applying the outdated 

Integrated Risk Information System (IRIS) dose-response values in determining formaldehyde 

inhalation exposure risk, EPA is not basing the Proposed Rule on the best available science. 

Moreover, EPA has not adequately supported its proposal to cap formaldehyde use in order to 

reduce residual risk.

ACC urges EPA to (1) reject the 1991 IRIS dose-response value; (2) delay the finalization of the 

Proposed Rule until the results of the National Academy of Sciences review of formaldehyde 
Docket ID No. EPA-HQ-OAR-2010-0786

February 22, 2011

Page 2

americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 

risk can be utilized in determining the best available science and incorporate that determination 

into the Proposed Rule; and (3) abandon its proposed cap on formaldehyde use.

ACC fully endorses and incorporates by reference the comments submitted by the Hamner 

Institutes for Health Sciences, the Residual Risk Coalition (R2C), the American Coatings 

Association (ACA), and the Kitchen Cabinet Manufacturers Association (KCMA).

If you have questions regarding this submission, please do not hesitate to contact me at (202) 

249-6139 or at laura_brust@americanchemistry.com.

Sincerely, 

Laura Brust

Laura A. Brust

Assistant General Counsel 
BEFORE THE

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

COMMENTS OF THE FORMALDEHYDE PANEL

OF THE AMERICAN CHEMISTRY COUNCIL

IN RESPONSE TO EPA’S PROPOSED NATIONAL EMISSION STANDARDS

FOR WOOD FURNITURE MANUFACTURING OPERATIONS

________________________________________________

National Emission Standards for Shipbuilding and Ship )

Repair (Surface Coating); National Emission Standards ) 

for Wood Furniture Manufacturing Operations; ) EPA-HQ-OAR-2010-0786

Proposed Rule ) 

75 Fed. Reg. 80220 (Dec. 21, 2010) )

David B. Fischer Laura A. Brust

Senior Director Assistant General Counsel

American Chemistry Council American Chemistry Council

Ann M. Mason

Senior Director

American Chemistry Council

February 22, 2011
i

EXECUTIVE SUMMARY

The Formaldehyde Panel of the American Chemistry Council (ACC) appreciates this 

opportunity to comment on the U.S. Environmental Protection Agency’s proposed rule for the 

National Emission Standards for Wood Furniture Manufacturing Operations (Proposed Rule). 

ACC strives to ensure appropriate product stewardship of chemicals, and as part of its mission, 

addresses important science and public policy issues related to formaldehyde chemistry, 

including proposed rulemaking and characterization of formaldehyde risk.

Despite the numerous safeguards designed by the Office of Management and Budget 

(OMB) and EPA to ensure data quality, EPA has failed to rely on the best available science in 

developing the Proposed Rule. EPA failed to comport with the Information Quality Act (IQA)

guidelines in crafting this rule. In particular, EPA incorporates the 1991 IRIS dose-response 

model – an overly conservative and outdated model – for determining the level of risk presented 

by formaldehyde exposure and ignored, without any rationale, nearly 25 years of research. The 

utilization of the IRIS model is all the more egregious considering the availability of the CIIT 

dose-response model, which better reflects the available science, and the impending release of 

the National Academy of Sciences (NAS) review of formaldehyde risk scheduled for March 

2011. Further, EPA relies on this inferior model to support its proposal to cap formaldehyde use 

in order to reduce residual risk. Instead of reducing any residual risk to public health, EPA’s 

proposed cap would unnecessarily limit the production of the wood furniture manufacturing 

sector.

As more fully discussed in these comments, ACC urges EPA to reject the 1991 IRIS 

dose-response model in setting the emissions standards for formaldehyde and delay the 

finalization of the rule until the NAS review is completed. Key deficiencies in the Proposed

Rule include:

ÿ Contrary to IQA Guidelines, EPA inappropriately applies the outdated IRIS doseresponse values in determining formaldehyde inhalation exposure risk in support of the 

Proposed Rule.

o The 1991 IRIS model does not constitute the best available science and 

therefore should not be used in determining formaldehyde inhalation exposure 

risk in support of the Proposed Rule.

ß The CIIT’s biologically based dose-response model is a superior 

model for determining the cancer risk associated with formaldehyde 

exposure.

ß EPA overstates the variability associated with CIIT’s model and bases 

its view on inappropriate manipulations of the model’s underlying 

assumptions. 
ii

o The NAS review of formaldehyde risk (to be completed in March 2011) 

constitutes the best available science.

ß The deference given to the 1991 IRIS Assessment is directly at odds 

with EPA’s mandate to “consider all credible and relevant 

information” in a rulemaking proceeding.

ß EPA’s proposed rule should be based on the best available science at 

the time of the rulemaking.

ÿ EPA has not adequately justified placing a 400-pound cap on formaldehyde use.

o The existing standards for the Wood Furniture Manufacturing source category 

provide an ample margin of safety to protect public health.

o The proposed cap is unlikely to reduce residual risk to public health because the 

best available science indicates that formaldehyde in outdoor air does not present 

a risk to human health.

o EPA does not provide any data to support its conclusion that it is feasible for all 

facilities to switch to low- or no-formaldehyde coatings and adhesives at little or 

no extra cost.

o Instead of reducing any residual risk to public health, the proposed cap would 

unnecessarily limit the production of the wood furniture manufacturing sector.

ACC urges EPA to revise the Proposed Rule to accurately convey the best available 

science and a weight-of-evidence approach in compliance with the IQA Guidelines and 

Executive Order 13563, and to adequately support its assumptions related to the proposed annual 

cap on formaldehyde use. In light of the ongoing NAS peer review of EPA’s Draft Integrated 

Risk Information System (IRIS) Toxicological Review of Formaldehyde Inhalation Assessment, 

ACC reserves the right to supplement its comments. In addition, ACC fully endorses and 

incorporates by reference the comments submitted by the Hamner Institutes for Health Sciences, 

the Residual Risk Coalition (R2C), the American Coatings Association (ACA), and the Kitchen 

Cabinet Manufacturers Association (KCMA).
iii

TABLE OF CONTENTS

EXECUTIVE SUMMARY ......................................................................................................... i

I. Introduction..........................................................................................................................1

II. The Proposed Rule is subject to EPA and OMB Information Quality Act Guidelines ...........2

III. Contrary to IQA Guidelines, EPA inappropriately applies the outdated IRIS dose-response 

values in determining formaldehyde inhalation exposure risk in support of the Proposed 

Rule .....................................................................................................................................3

A. The IRIS value does not constitute the best available science and therefore should not 

be used in determining formaldehyde inhalation exposure risk in support of the 

Proposed Rule ...............................................................................................................5

1. The CIIT’s biologically based dose-response model is a superior model for 

determining the cancer risk associated with formaldehyde exposure .......................5

2. EPA overstates the variability associated with CIIT’s model and bases its view on 

inappropriate manipulations of the model’s underlying assumptions.......................6

B. The NAS review (to be completed by March 2011) should be used in determining what 

constitutes the best available science .............................................................................8

1. The deference given to the 1991 IRIS Assessment is directly at odds with EPA’s 

mandate to “consider all credible and relevant information” in a rulemaking 

proceeding..............................................................................................................8

2. EPA’s proposed rule should be based on the best available science at the time of 

the rulemaking........................................................................................................9

IV. EPA has not adequately justified placing a 400-pound cap on formaldehyde use ................10

A. EPA has not demonstrated that the cap will reduce residual risk ..................................11

B. EPA does not adequately support its cost estimate.......................................................12

V. Conclusion.........................................................................................................................13

References ................................................................................................................................14
1

I. Introduction

The Formaldehyde Panel of the American Chemistry Council (ACC) appreciates this 

opportunity to comment on the U.S. Environmental Protection Agency’s proposed rule for the 

National Emission Standards for Wood Furniture Manufacturing Operations (Proposed Rule). 

ACC strives to ensure appropriate product stewardship of chemicals, and as part of its mission, 

addresses important science and public policy issues related to formaldehyde chemistry, 

including proposed rulemaking and characterization of formaldehyde risk. 

As set forth in these comments, EPA has failed to comport with the explicit Information 

Quality Act (IQA) Guidelines. The information that serves as a basis for the Proposed Rule is 

“influential” scientific risk assessment information and therefore must adhere to a rigorous 

standard of quality. Despite the requirements of the IQA Guidelines, EPA has failed to support 

key conclusions in the Proposed Rule with the best available science. By applying the outdated

Integrated Risk Information System (IRIS) dose-response values in determining formaldehyde 

inhalation exposure risk, EPA is not basing the Proposed Rule on the best available science. 

Moreover, EPA has not adequately supported its proposal to cap formaldehyde use in order to 

reduce residual risk.

Given the pending National Academy of Sciences (NAS) peer review of EPA’s Draft 

IRIS Toxicological Review of Formaldehyde Inhalation Assessment (Draft IRIS Assessment),

which is expected to be completed in March 2011, this rulemaking is premature. Importantly, 

EPA requested the NAS review the Agency’s conclusion regarding formaldehyde risk, the 

paramount issue directly relevant to this rulemaking. Prior to issuing the final National Emission 

Standards for Wood Furniture Manufacturing Operations, therefore, EPA should fully consider 

the best available science, including the results of the NAS peer review of the Draft IRIS 

Assessment. ACC recognizes that EPA faces significant time constraints due to the obligations 

imposed by the Consent Decree in Sierra Club v. Jackson, No. 09-cv-00152 SBA (N.D. Cal.), 

but these deadlines do not override EPA’s obligation to base the Proposed Rule on the best 

available science pursuant to the IQA Guidelines.

The critical importance of using best available science as a basis for regulatory decisions 

is well established. On January 18, 2011, President Obama issued Executive Order 13563, in 

which the President ordered executive agencies to improve regulation and regulatory review. 

The President stresses the importance of protecting public health and the environment “while 

promoting economic growth, innovation, competitiveness, and job creation.” 76 Fed. Reg. 3821, 

3821 (Jan. 21, 2011). The regulatory system must “be based on the best available science,”

“identify and use the best, most innovative, and least burdensome tools for achieving regulatory 

ends,” and “take into account benefits and costs, both quantitative and qualitative.” Id.

Importantly, an agency can propose or adopt a regulation “only upon a reasoned determination 

that its benefits justify its costs.” Id. Moreover, “each agency shall ensure the objectivity of any 

scientific and technological information and processes used to support the agency’s regulatory 
2

actions.” Id. at 3822. In finalizing this rulemaking, EPA must comply with the provisions of the 

Executive Order.

ACC urges EPA to revise the Proposed Rule to accurately convey the best available 

science and a weight-of-evidence approach in compliance with the IQA Guidelines and 

Executive Order 13563, and to adequately support its assumptions related to the proposed annual 

cap on formaldehyde use. In particular, EPA should (1) reject the 1991 IRIS dose-response

value; (2) delay the finalization of the Proposed Rule until the results of the NAS review can be 

used to determine the best available science and modify the risk values in the Proposed Rule 

appropriately; and (3) abandon its proposed cap on formaldehyde use.

In light of the ongoing NAS peer review of the Draft IRIS Assessment, ACC reserves the 

right to supplement its comments on this Proposed Rule. In addition, ACC fully endorses and 

incorporates by reference the comments submitted by the Hamner Institutes for Health Sciences, 

the Residual Risk Coalition (R2C), the American Coatings Association (ACA), and the Kitchen 

Cabinet Manufacturers Association (KCMA).

II. The Proposed Rule is subject to EPA and OMB Information Quality Act Guidelines

Congress enacted the Information Quality Act, Pub. L. No. 106-554, 114 Stat. 2763A153 to 2763A-154, to “ensur[e,] and maximiz[e,] the quality, objectivity, utility and integrity of 

information ... disseminated by Federal agencies” such as the EPA. The IQA required the 

Office of Management and Budget (OMB) to issue government-wide guidance, which each 

federal agency was to follow through issuance of its own guidelines. In February 2002, OMB 

issued its guidelines, and EPA issued its agency-specific guidelines (EPA IQA Guidelines) later 

that year.1 The purpose of the EPA IQA Guidelines is to apply the OMB Guidelines to the 

Agency’s particular circumstances, and to “establish administrative mechanisms allowing 

affected persons to seek and obtain correction of information ... disseminated by the agency that 

does not comply with the [OMB] guidelines....” The information that serves as the basis for 

EPA’s proposed rule for the National Emission Standards for Wood Furniture Manufacturing 

Operations must meet OMB’s guidelines as well as the Agency’s own guidelines.

The information that serves as a basis for the Proposed Rule is influential information and 

must adhere to a rigorous standard of quality. The Proposed Rule for the National Emission 

Standards for Wood Furniture Manufacturing Operations is based on “influential” scientific risk 

 1 OMB, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and 

Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 

2002) (OMB IQA Guidelines); see EPA, Guidelines for Ensuring and Maximizing the 

Quality, Objectivity, Utility, and Integrity of Information Disseminated by the 

Environmental Protection Agency, available at http://www.epa.gov/quality/

informationguidelines/documents/EPA_InfoQualityGuidelines.pdf.
3

assessment information as set forth in EPA IQA Guidelines2 because it contains “information 

disseminated in support to top Agency actions (i.e., rules...)” and is “[m]ajor work product[]”

that “will have ... a clear and substantial impact (i.e., potential change or effect) on important 

public policies or private sector decisions.”3 The information underlying the Proposed Rule, 

therefore, must adhere to a rigorous standard of quality. The substance of the information must 

be “accurate, reliable, and unbiased.” EPA must use the best available science and supporting 

studies, as well as “a weight-of-evidence approach that considers all relevant information and its 

quality.”4

EPA must present the information in a “comprehensive, informative, and understandable”

manner, specifying:

· Each population addressed by any estimate of applicable human health risk;

· The expected risk or central estimate of human health risk for the specific 

populations affected;

· Each appropriate upper-bound or lower-bound estimate of risk;

· Each significant uncertainty identified in the process of the assessment of risk and 

studies that would assist in resolving the uncertainty; and

· Peer-reviewed studies known to support, are directly relevant to, or fail to support 

any estimate of risk and the methodology used to reconcile inconsistencies in the 

scientific data.5

III. Contrary to IQA Guidelines, EPA inappropriately applies the outdated IRIS doseresponse values in determining formaldehyde inhalation exposure risk in support of 

the Proposed Rule

In 2004, EPA determined that “the dose-response value in IRIS is based on a 1987 study, 

and no longer represents the best available science in the peer reviewed literature.” 69 Fed. Reg. 

18327, 18333 (Apr. 7, 2004). EPA went on to state that “the CIIT modeling effort represents the 

best available application of the available mechanistic and dosimetric science on the doseresponse for portal of entry cancers due to formaldehyde exposure.” Id. This determination led 

 2 Pub. L. No. 106-554. The Information Quality Act was developed as a supplement to the 

Paperwork Reduction Act, 44 U.S.C. §3501 et seq., which requires OMB, among other 

things, to “develop and oversee the implementation of policies, principles, standards, and 

guidelines to ... apply to Federal agency dissemination of public information.”

3 EPA IQA Guidelines at 19 (internal citations omitted); OMB IQA Guidelines at 8455.

4 Quality includes objectivity, utility, and integrity.

5 EPA IQA Guidelines at 22-23; OMB IQA Guidelines at 8458.
4

to the incorporation of the CIIT dose-response value for formaldehyde exposure in risk 

assessments supporting regulatory action. In the underlying risk assessment for the Proposed 

Rule, however, EPA reverses its position on what constitutes the best available science by stating 

that EPA no longer considers “the CIIT URE value health protective, and we are again using the 

EPA’s current value on IRIS, which was last revised in 1991....” 75 Fed. Reg. 80220, 80228 

(Dec. 21, 2010).

The CIIT’s construction of a biologically based dose-response (BBDR) model to 

determine an appropriate dose-response value by utilizing a detailed understanding of 

formaldehyde’s cancer mode of action (MOA) is a superior model for predicting cancer risk than 

the 1991 IRIS model. Further, current science supports the robustness of the CIIT dose-response 

model. The sensitivity of the model was questioned based on inappropriate manipulation, 

rebutting EPA’s assertion that the variability of the model is “not supportive of interpreting the 

CIIT model results as providing a conservative (health-prospective) estimate of human risk.” Id.

(citing Crump et al., 2008). In fact, an NAS panel has already reviewed the CIIT model and 

determined that it is superior to the 1991 IRIS value:

The available evidence, however, strongly suggests that the risk from 

formaldehyde at high doses demonstrated in animals studies cannot be 

extrapolated to lower doses using the EPA’s approach (Conolly et al. 2003; 

Gaylor et al. 2004). The more recent CIIT assessment results in a theoretical 

cancer risk well below the U.S. Department of Defense “acceptable” risk level of 

1 in 10,000, even for lifetime exposure at the 0.3-ppm 90-day CEGL. The 

subcommittee concluded that the CIIT assessment more accurately reflects the 

scientific weight of evidence for formaldehyde carcinogenicity than does EPA’s 

approach (NAS, 2007, p. 131).

EPA should not ignore the NAS’s conclusion by reverting to a twenty year old IRIS assessment 

value that is not supported by the best available science. 

Moreover, there are substantial limitations associated with the 1991 IRIS value that 

makes its use in setting emissions standards inappropriate. Substantial research has been 

conducted in the past 20 years that invalidates the IRIS dose-response value for formaldehyde 

exposure. The NAS is currently reviewing EPA’s Draft IRIS Assessment of formaldehyde. 

EPA should delay the finalization of the Proposed Rule until the NAS review is completed in 

March 2011, so that EPA can fully incorporate the NAS’s findings regarding formaldehyde and 

risk into the emission standards for the Wood Furniture Manufacturing source category.
5

A. The IRIS value does not constitute the best available science and therefore 

should not be used in determining formaldehyde inhalation exposure risk in 

support of the Proposed Rule

1. The CIIT’s biologically based dose-response model is a superior 

model for determining the cancer risk associated with formaldehyde 

exposure

With input from EPA, Health Canada, and peer reviewers, a team of researchers at CIIT 

incorporated over 20 years of research to develop a biologically motivated model to help 

characterize the roles of regenerative cellular proliferation (RCP) and DNA-protein cross-link

(DPX) formation in formaldehyde carcinogenicity (CIIT, 1999). The important design features 

and assumptions integrated into CIIT’s BBDR model include the following: 

· The dosimetry model includes high-resolution descriptions of the nasal airways of 

rats and of the entire human respiratory tract and provides accurate, site-specific 

dosimetry predictions (Kimbell et al., 1993; Subramaniam et al., 1998; Kimbell et al., 

2001; Overton et al., 2001).

o This site-specificity allows researchers to isolate certain regions of the 

respiratory tract based on the level of exposure they receive. This 

difference in exposure could result in varying levels of DPX formation, 

cytolethality, and RCP. 

o The availability of these dosimetry models for rats, rhesus monkeys and 

humans means that not only can regional dosimetry be predicted for a 

given species but also that the differences in anatomy to be incorporated in 

a meaningful manner into interspecies extrapolations of formaldehyde 

dosimetry (Kimbell et al., 2001).

· CIIT (1999) uses a two-stage clonal growth model in place of the linearized 

multistage (LMS) model that is used by EPA in the 1991 risk assessment for 

formaldehyde (U.S. EPA, 1991).

o The LMS model does not afford a straightforward means of incorporating 

data on RCP, and no previous cancer risk assessments for formaldehyde 

have incorporated RCP data. 

o CIIT (1999) describes cancer as a multistage process, with cell replication 

occurring within each stage and mutation responsible for movement of 

cells from one stage to the next. The clonal growth model thus provides a 

framework for simultaneous incorporation of both RCP and DPX data 
6

and, moreover, specifies how these two modes of action contributed to 

tumor formation. 

· When compared to earlier cancer risk models for formaldehyde based on the LMS 

model, the CIIT model is more biologically plausible and, therefore, represents a 

reduction in uncertainty relative to the earlier models.

o The IRIS model uses DPX data to account for nonlinearities in 

pharmacokinetics (PK), but does not consider the variation in 

formaldehyde dosimetry throughout the respiratory tract. 

o Kimbell et al. (2001) found that partitioning of the nasal surface area into 

20 discrete regions on the basis of regional variation in flux was required 

to adequately account for the role of nasal anatomy as a determinant of 

tissue dosimetry. 

o The clonal growth model provides a biologically plausible structure for 

incorporating DPX and RCP data representing distinct but interacting 

modes of action. The overall dosimetry-clonal growth model is as 

sophisticated a model of the carcinogenic process for formaldehyde as is 

possible given currently available data. 

· Linear extrapolation through the origin from the point-of-departure for increased 

tumor incidence employed by the 1991 EPA risk assessment for formaldehyde is not 

supported by recent studies.

o Dose-dependent transitions for mutation are present for DNA-reactive 

compounds (Swenberg et al., 2008) with low dose damage adequately 

repaired and high doses leading to such extensive damage that DNA 

integrity cannot be maintained.

o The endogenous levels of tissue formaldehyde cause DNA damage can be 

remedied by constitutive DNA repair. Further, at exposure concentrations 

less than 1 ppm, inhalation of formaldehyde is not expected to increase the 

tissue concentration of formaldehyde from endogenous levels.

2. EPA overstates the variability associated with CIIT’s model and 

bases its view on inappropriate manipulations of the model’s 

underlying assumptions

In its 2004 proposed rule regarding the National Emissions Standards for Hazardous Air 

Pollutants for Stationary Combustion Turbines, EPA stated “that the CIIT modeling effort 

represents the best available application of the available mechanistic and dosimetric science on 

the dose-response for portal of entry cancers due to formaldehyde exposures.” 69 Fed. Reg. at 
7

18333. This determination accompanied EPA’s assertion that “the dose-response value in IRIS 

is based on a 1987 study, and no longer represents the best available science in the peer reviewed 

literature.” Id. In the current Proposed Rule, the EPA reverts back to the 1991 IRIS doseresponse value because “recent research published by EPA indicates that, when the CIIT’s two 

stage modeling assumptions are varied, resulting dose-response estimates can vary by several 

orders of magnitude.” 75 Fed. Reg. at 80228. The validity of this conclusion, however, is 

severely undermined due to the EPA’s reliance on the conclusions of Crump et al. (2008), which 

inappropriately adjusted the parameterization of intermediate (I) cells in the Clonal Growth (CG)

model which resulted in inappropriate estimates of cancer risk. See Conolly et al. (2009).

As explained by Conolly et al. (2009), while it is important to ensure that the CIIT model 

is “health protective” in its estimation of cancer risk by performing a sensitivity analysis, such an 

analysis is only valuable if it is constrained by respect for the biological realism of the modelpredicted behavior. This simply is not the case here. In performing their sensitivity analysis, 

Crump et al. (2008) introduced arbitrary adjustments to the kinetics of the I cells in the CG 

model. Using these adjustments, the new model predicted that anywhere from 1 in 100 people 

exposed to nearly all of those exposed to formaldehyde at a concentration on the order of 0.1 

ppm would contract cancer. To date, there have been numerous epidemiological studies 

conducted where subjects are exposed to concentrations of formaldehyde of 0.1 ppm and higher 

and have failed to indicate cancer risk levels approaching those predicted by the Crump et al.

(2008) adjusted model. 

Crump et al. (2008) justified the adjustments to the I cell kinetics by referencing the 

research of Heck and Casanova (1999), which discussed the effect of DPX and its effect on cell 

replication. Crump et al. (2008), however, misinterpret the conclusions of the research. Heck 

and Casanova (1999) posited that DPX physically blocks the replication complex as it moves

along the DNA strand, resulting in a slowing of the cellular replication process because the 

replication complex would remain stalled until the offending DPX was removed. Crump et al.

(2008) interpreted the research as meaning that the formation of DPX activates a checkpoint in 

the cell cycle, providing extra time for repair of the DNA lesion. If the mutation impairs the 

ability to activate the checkpoint, then the I cells would increase their rate of division. This 

fundamental misunderstanding of Heck and Casanova (1999) has a significant effect on the 

appropriateness of the adjustments to the I cell kinetics.

It is also important to note that the treatment of I cell kinetics by Crump et al. (2008) 

involved the dissociation of I cell kinetics from the kinetics of normal cells, specifically at low, 

non-tumorigenic levels of exposure to formaldehyde. These novel behaviors for I cells would 

require a low-dose mitogenic mechanism for formaldehyde that is specific to I cells and that does 

not occur in normal cells. In fact, the data for normal cells show a low dose decrease in division 

rate, the opposite of mitogenesis. Crump et al. (2008) thus, implemented a much more 

complicated parameterization of I cells for which there is no scientific evidence. It is well 
8

known that CG models are sensitive to their cell kinetics parameters (Gaylor and Zheng, 1996) 

and therefore the result obtained by Crump et al. (2008) is not surprising. 

In short, the greatly inflated risk predicted by the Crump et al. (2008) model can be 

attributed to an increased rate of I cell division at low levels of exposure to formaldehyde based 

on a speculative treatment of I cell kinetics that has neither empirical nor theoretical support. 

This inappropriate manipulation of the I cell kinetics not only overstates the cancer risk 

associated with formaldehyde exposure, but also overstates the variability of the model.

B. The NAS review (to be completed by March 2011) should be used in 

determining what constitutes the best available science

1. The deference given to the 1991 IRIS Assessment is directly at odds 

with EPA’s mandate to “consider all credible and relevant 

information” in a rulemaking proceeding

EPA’s reservations as to whether the variability displayed by the CIIT model provides a 

“conservative (health perspective) estimate of human risk” is not, by itself, a sound basis for 

adopting the 1991 IRIS values. EPA has repeatedly emphasized that the Agency is required to 

consider other information, in addition to the IRIS database, when evaluating health effects in a 

regulatory context. See Community Nutrition Instit. v. Young, 818 F.2d 943, 946 (D.C. Cir. 

1987), McLoud Steel Prods. Corp. v. EPA, 838 F.2d 1317 (D.C. Cir. 1988).

In guidance on the use of IRIS for purposes of developing values under the early 

reduction program of the Clean Air Act, EPA noted:

It is also important to remember that IRIS is not a comprehensive toxicological 

database. There may be more recent information available than is contained in 

IRIS. Moreover, the act of including a value in IRIS is not subject to notice and 

comment rulemaking, and may not necessarily have been subjected to external 

peer review.... Accordingly, IRIS values are not entitled to conclusive weight 

and shall not be made legally binding in the context of any other rulemaking 

action. In addition, EPA or any State agency that uses IRIS should not rely 

exclusively on IRIS values but should consider all credible and relevant 

information that is submitted in any particular rulemaking. If an outside party 

questions IRIS values during the course of an EPA proceeding..., EPA will 

consider all credible and relevant information before it in that proceeding (U.S. 

EPA, 1994).

The importance of considering all recent and relevant information instead of simply using 

IRIS assessment values as default values in Agency actions is echoed in an EPA Office of Solid 

Waste and Emergency Response (OSWER) directive, which states:
9

IRIS is not the only source of toxicological information and in some case more 

recent, credible and relevant data may come to the Agency’s attention ... such 

information should be considered along with the data in IRIS in selecting 

toxicological values; ultimately, the Agency should evaluate risk based on its best 

scientific judgment and consider all credible and relevant information available to 

it (U.S. EPA, 1993).

The need for a careful examination of recent, relevant data and research in determining 

an appropriate toxicological value is quite evident in the case of the formaldehyde dose-response 

value where the IRIS dose-response value is based on a study that is over twenty years old. This 

fact was emphasized in the 2004 proposed rule for the National Emission Standards for 

Hazardous Air Pollutants for Stationary Combustion Turbines, 40 CFR Part 63, where, in its 

discussion of the formaldehyde dose-response value, EPA states “the dose-response value in 

IRIS is based on a 1987 study, and no longer represents the best available science in the peer 

reviewed literature. Since that time significant new data and analysis has become available.” 69 

Fed. Reg. at 18333.

Although EPA now disagrees with the conclusions of this earlier rule, EPA still bears the 

burden of conducting a comprehensive literature review to ensure that no additional research has 

been conducted that calls into question the validity of the IRIS assessment. Unfortunately, the 

extent of review in the Proposed Rule does not meet the level of scrutiny described above by 

EPA. The Agency merely questions the validity of the CIIT URE value and reverts back to the 

1991 IRIS assessment value as a default value, stating “we no longer consider the CIIT URE 

value health protective, and we are again using the EPA’s current value on IRIS, which was last 

revised in 1991....” 75 Fed. Reg. at 80228. This EPA conclusion is in direct conflict with the 

view of the NAS subcommittee that concluded the “CIIT assessment more accurately reflects the 

scientific weight of evidence for formaldehyde carcinogenicity than does EPA’s approach”

(NAS, 2007, p. 131).

2. EPA’s proposed rule should be based on the best available science at 

the time of the rulemaking

EPA’s reversion to the 1991 IRIS assessment value for use in the Proposed Rule not only 

violates its own guidance on the use of IRIS for purposes of developing toxicological values, but 

also fails to meet the rigorous data quality standards for “influential information” outlined in the 

IQA Guidelines. As stated above, the IQA Guidelines for influential information require EPA to 

use the best available science and supporting studies, as well as “a weight-of-evidence approach 

that considers all relevant information and its quality.” EPA IQA Guidelines at 21 (internal 

citations omitted). To determine what constitutes the “best available science,” EPA is required 

to conduct a comprehensive review of the available science, and make a determination based on 

the weight-of-evidence. EPA overly simplified this process by determining that the only two 

viable dose-response values were the CIIT value and the 1991 IRIS value. EPA defaulted to the 
10

1991 IRIS value without conducting a comprehensive review of the considerable body of 

research that has been conducted in the past twenty years that may suggest an alternative value 

that is supported by the best available science. This issue can be remedied by simply delaying 

the finalization of the Proposed Rule until the NAS has the opportunity to complete its review. 

This review will incorporate the studies conducted in the past 20 years and determine what 

constitutes the best available science.

ACC understands that the Consent Decree in Sierra Club v. Jackson, No. 09-cv-00152 

SBA (N.D. Cal.), imposes a deadline of October 31, 2011 to sign a final rule promulgating 

revisions to NESHAP subpart JJ under Clean Air Act (CAA) Section 112(d)(6), or sign a final 

determination that revision of NESHAP subpart JJ is not necessary under CAA Section 

112(d)(6), and sign a final rule promulgating residual risk standards for this source category 

under CAA Section 112(f)(2), or sign a final determination that promulgation of such standards 

is not required under CAA Section 112(f)(2). However, to disseminate influential information of 

questionable validity severely undermines the legitimacy of the rule.

The U.S. Court of Appeals for the D.C. Circuit, in Chlorine Chemistry Council v. EPA, 

206 F.3d 1286 (D.C. Cir. 2000), further underscored the importance of rulemaking “on the basis 

of the best available science at the time of the rulemaking.” Id. at 1291 (emphasis in original).

In holding that the best available science is the science available at the time of rulemaking, the 

court unanimously rejected EPA’s contention that it would defer the application of the best 

available science until after input from the Science Advisory Board on the carcinogenic mode of 

action of chloroform. “The word ‘available’ would be senseless if construed to mean ‘expected 

to be available at some future date.’” Id. Similarly, the research and data currently being 

considered in the NAS review of the Draft IRIS Assessment must be incorporated into this 

rulemaking; EPA cannot legally defer application of the best available science.

For the foregoing reasons, ACC asks that the EPA reject the 1991 IRIS model and its 

corresponding dose-response value and delay the finalization of the Proposed Rule until the NAS 

review is completed to determine what constitutes the best available science. Further, ACC asks 

that the Proposed Rule to be modified to reflect the best available science.

IV. EPA has not adequately justified placing a 400-pound cap on formaldehyde use

Section 112(f)(2) of the CAA requires EPA to promulgate standards to provide “an ample 

margin of safety to protect public health.” After considering the “various health measures and 

factors and uncertainties” relating to the Wood Furniture Manufacturing Operations source 

category, EPA concludes that risks from the category are acceptable. 75 Fed. Reg. at 80245. 

Nevertheless, in order to provide an “ample margin of safety,” EPA proposes “to limit 

formaldehyde emissions by restricting formaldehyde use to 400 pounds per rolling 12 month 

period,” which would apply to wood furniture coatings and contact adhesives. Id. at 80246. 

EPA contends that “it is feasible ... to switch to coatings and adhesives containing no or low 
11

amounts of formaldehyde at little or no extra cost....” Id. EPA has not demonstrated, however, 

that the cap will reduce residual risk and has not adequately supported its cost estimate. Instead, 

EPA’s cap will unnecessarily limit wood furniture production and EPA should not adopt the 

proposed standard.

A. EPA has not demonstrated that the cap will reduce residual risk

EPA asserts that the proposed cap on formaldehyde use will “reduce the maximum acute 

[hazard quotient] HQ value based on the [reference exposure level] REL for formaldehyde from 

7 to 3, and will reduce the maximum lifetime individual cancer risk from 20-in-1 million to 

approximately 10-in-1 million, both based on the actual emissions level.”6 Id. However, EPA 

incorporates a number of conservative assumptions into its acute effects analysis, including 

emission rates, meteorology, and exposure location. Id. at 80229. In addition, EPA 

acknowledges that the RELs are very conservative, concluding “[s]ince margins of safety are 

incorporated to address data gaps and uncertainties, exceeding the acute REL does not 

automatically indicate an adverse health impact.” Id. Therefore, even though EPA predicts that 

the HQ based on the REL is above one (“1”) for certain facilities, EPA “did not see a potential 

for any facility to cause exceedances of the acute ERPG-1 or AEGL-1 levels.” Id. at 80246; see 

also U.S. EPA, Draft Residual Risk Assessment for the Wood Furniture Manufacturing Source 

Category (Dec. 2010), at 33 (“The maximum acute HQ for formaldehyde based on an AEGL-1 

or ERPG-1 value is 0.35, indicating that [reversible adverse] effects (which are generally eye and 

nose irritation) might not be expected to occur.”).7 In addition, EPA’s risk assessment concludes 

that the cancer incidence associated with hazardous air pollutant (HAP) emissions from the 

Wood Furniture Manufacturing Operations source category is only “1 [case] in every 200 

years.”8 75 Fed. Reg. at 80244. Based on EPA’s analysis of both acute and chronic effects, the 

existing standards provide an ample margin of safety to protect public health.

Moreover, the proposed 400-pound cap on formaldehyde use is unlikely to reduce 

residual risk to public health because the best available science indicates that formaldehyde in 

outdoor air does not present a risk to human health. The World Health Organization (WHO) 

found that “[i]n ambient air, formaldehyde is quickly photo-oxidized in carbon dioxide. It also 

reacts very quickly with the hydroxyl radicals to give formic acid. The half-life estimated for 

these reactions is about one hour depending on the environmental conditions.” (WHO, 2010, at 

 6 EPA also notes that “the estimated reduction in cancer MIR would be negligible if the 

CIIT URE for formaldehyde were used instead of the IRIS URE.” 75 Fed. Reg. at 80246 

n.39. Therefore, using risk values determined by the best available science, as discussed 

above, the proposed cap would not lead to any reduction in residual risk.

7 Docket Item EPA-HQ-OAR-2010-0786-0017.

8 Cancer incidence would be reduced by 30 percent if EPA were to use the CIIT URE for 

formaldehyde. 75 Fed. Reg. at 80244 n.36.
12

103). Further, WHO concluded that because levels in ambient air are low, outdoor air does not 

contribute significantly to indoor pollution. Id. at 108. Therefore, EPA’s proposed cap on 

formaldehyde use is an unnecessary restriction that will not reduce residual risk, if any, to public 

health.

B. EPA does not adequately support its cost estimate

EPA does not provide any data to support its conclusion that “it is feasible ... to switch to 

coatings and adhesives containing no or low amounts of formaldehyde, at little or no extra 

cost....” 75 Fed. Reg. at 80246. Instead, EPA’s technical analysis consists of the unsupported 

assertions that facilities currently using more than 400 pounds of formaldehyde per year are 

similar in operations to facilities using less than 400 pounds per year and that “[m]any facilities 

currently use these no- or low-formaldehyde coatings and adhesives.” Id. Therefore, EPA 

concludes that “it is feasible for the remaining facilities ... to switch to coatings and adhesives 

containing no or low amounts of formaldehyde, at little or no extra cost, and reduce their overall 

usage to no more than 400 pounds per rolling 12 month period.” Id. EPA provides no data or 

analysis to support its assumption that facility operations are the same or that the use of no- or 

low- formaldehyde coatings and adhesives would be suitable for use by all facilities. In fact, the 

comment submitted by John Gahm of Kitchen Kompact provides a concrete example to show 

that not all facilities can feasibly switch to no- or low-formaldehyde coatings.9

In addition, EPA asserts that since “[t]here are many coatings and adhesives available 

from several suppliers that contain no or low quantities of formaldehyde and that are 

approximately equivalent in cost to the coatings and adhesives that contain formaldehyde,” the 

proposed standard could be achieved “at little or no extra cost.” 75 Fed. Reg. at 80246. EPA’s 

“cost analysis” consists of price information, from one supplier, of thirteen no- or lowformaldehyde coatings that the Agency considers to be suitable for use in wood furniture 

manufacturing operations. See U.S. EPA, Memo: Impacts of Implementing a Limit on 

Formaldehyde Usage in the Wood Furniture Manufacturing Operations Source Category (Oct. 

19, 2010), at 2 and Table 2.10 Not only does EPA not list any no- or low-formaldehyde contact 

adhesives, it does not analyze whether the available coatings can be used in all applications or 

would meet industry performance standards. Moreover, EPA does not address the additional 

costs incurred due to the potential need for new equipment. Again, Mr. Gahm’s comment 

demonstrates that EPA did not thoroughly analyze the cost implications of the proposed cap:

In order for our company to comply with the proposed standards, we would 

realize significant expenses.... Expenses would not only involve increases in 

material but also significant expenses to our facility to adapt to a new finish 

material that we are not currently using... and that is not even addressing the 

 9 Docket Item EPA-HQ-OAR-2010-0786-0038.

10 Docket Item EPA-HQ-OAR-2010-0786-0029.
13

future in which we hope for an increase in business which in turn would result in 

more finish material used in our facility.11

Instead of reducing any residual risk to public health, EPA’s proposed cap would 

unnecessarily limit the production of the wood furniture manufacturing sector. As stated by 

KCMA, the proposed cap could limit a facility’s use to as little as 40,000 gallons of finish in a 

12-month period, restricting the facility’s production and the industry’s ability to provide muchneeded jobs to communities around the country.

Without a demonstration that the proposed cap would reduce residual risk and without 

providing adequate cost and technical analyses, EPA cannot impose this unnecessary standard on 

the wood furniture manufacturing industry pursuant to either Section 112(f)(2)(A) or 112(d)(6) 

of the CAA.

V. Conclusion

ACC appreciates this opportunity to comment on EPA’s proposed rule for the National 

Emission Standards for Wood Furniture Manufacturing Operations. For all the reasons 

discussed above, ACC urges EPA to (1) reject the 1991 IRIS dose-response value; (2) delay the 

finalization of the Proposed Rule until the results of the NAS review can be utilized in 

determining the best available science and incorporate that determination into the Proposed Rule; 

and (3) abandon its proposed cap on formaldehyde use.

 11 Docket Item EPA-HQ-OAR-2010-0786-0038.
14

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