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 By applying the outdated Integrated Risk Information System (IRIS) dose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 N ational A cademy of S ciences review of formaldehydeDocket 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 CounselBEFORE 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. 80 220 (D ec. 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, 2011i EXECUTIV E 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 (Pr oposed 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 for maldehyde risk.

De spite 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 fail ed to comport with the Info rmation Quality Act ( IQA ) guidelines in crafting this rule . In particular, EPA incorporate s the 1991 IRIS dose

- response model – an overly conservative and outdated model – for determining the level of risk presented by formaldehyde exposure and ignored, w ithout 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

- re s ponse model
, which better reflects the available science
, and the impending release of the Nati onal 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 pub lic 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 re ject 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 Propose d Rule include:

ÿ Contrary to IQA Guidelines, EPA inappropriately applies the outdated IRIS dose

response values in determining formaldehyd e inhalation exposure risk in support of the Proposed Rule

.

o T he 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 b iologically b ased d ose

- r esponse m odel 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 r eview 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 relev ant 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 h as n ot a dequately j ustified p lacing a 400

- p ound c ap on f ormaldehyde u se

.

o T he existing standard s for the Wood Furniture Manufacturing source category provide an ample margin of safety to protect public health.

o T he proposed cap is unlikely to reduce residual risk to public health because the best available science indicates that formaldehyde in outdoor air does not p resent 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 f urniture 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 u se. In light of the ongoing NAS peer review of EPA ’ s Draft Integrated Risk Information System (IRIS) Toxicolog ical 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 Coal ition (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

- res ponse model is a superior model for determining the cancer risk associated with formaldehyde exposure

....................... 5

2. EPA overstates the v ariability 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

................................ ................................ ................................ ................................ 141 I. Introducti on 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 formaldehy de 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 there fore 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. B y applying the outdated Integrated Risk Information Syste m ( 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 support ed its proposal to cap formaldehyde use in order to reduce resid ual risk.

G iven 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 Fur niture 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 a s a basis for regulatory decisions is well established. On January 18, 2011, President Obama issue d Executive Order 13563, in which the President ordered executive agencies to improve regulation and regulatory review. The President stresses the importanc e 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 an d 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 regulatory2 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 O rder 13 563, 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 rev iew 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 Associa tion (ACA), and the Kitchen Cabinet Manufacturers Association (KCMA).

II. The Proposed Rule is subject to EPA and OMB Information Quality Act Guidelines
Congress enac ted the Information Quality Act , Pub. L. No. 106

- 554, 114 St at. 2763A

153 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 federa l 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 Gui delines to the A gency ’ 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 informa tion 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
, Gui delines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies
, 67 F ed

. R eg . 8452 (Feb. 22, 2002) (OMB IQA Guidelines) ; s ee EPA, Guidelines for Ensuring and Maximizing the Quality, Objec tivity, 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 f orth in EPA IQA Guidelines 2 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 publ ic policies or private sector d ecisions. ” 3 The information underlying the P roposed R ule, 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 availabl e 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 populatio n 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 identi fied 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 in consistencies in the scientific data. 5

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
In 2004, EPA determined that “ th e 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 bes t available application of the available mechanistic and dosimetric science on the do s e

response for portal of entry cancers due to formaldehyde exposure. ” Id. This determination le d

2 Pub. L. No. 106

- 554. The Information Quality Act w as 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 845 5.

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 e xposure 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 consider s “ the CIIT URE valu e 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 appropriat e 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 do s e

- response

m

odel . T he 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) e stimate of human risk. ” Id. (c iting Crump et al.
, 2008 )

. In fact, a n 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 formaldehy de 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 d oes 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 t he 1991 IRIS value that makes its use in setting emissions standards inappropriate. Substantial research has been conducted in the past 20 years that invalidate s 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 standard s for the Wood Furniture Manufacturing source category

.5 A. T he 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 b io logically b ased d ose - r esponse m odel is a superior model for determining the cancer risk associ ated 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 de velop a biologically motivated model to help characterize the roles of regenerative cellular proliferation ( RCP ) and DNA

- p rotein c ross

- link ( DPX ) formation in formaldehyde carcinogenicity (CIIT, 1999). The important design features and assumptions integra ted into CIIT ’ s BBDR m odel 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 do simetry 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 resul t 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 anato my to be incorporated in a meaningful manner into interspecies extrapola tions 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 t he 19 91 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 a s 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 provide s a framework for simultaneous incorporation of both RCP and DPX data6 an d, moreover, specifie s 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 biol ogically 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 mutati on 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 damag e 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 a ssociated 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 st ated “ that the CIIT modeling effort represents the best available application of the available mechanistic and dosimetric science on the dos e

- response for portal of entry cancers due to formaldehyde exposures. ” 69 Fed. Reg. at7 18333

. This determination a ccompanied 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 dose

response 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 co nclusion, 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 C lonal G rowth (CG) model which resulted in inappropriate est imates of cancer risk. See Conolly et al. (2009).
As explained by Conolly et al. (2009), w hile 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 model

predicted 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 discusse d th e effect of DPX and its effect on cell replication. Crump et al. (2008) , however, misinterpret the conclusions of th e research. Heck and Casanova (1999) posit ed 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 off ending DPX was removed. Crump et al. (2008) interpret ed 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 che ckpoint, 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) involve d 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, imple mented a much more complicated parameterization of I cells for which there is no scientific evidence. It is well8 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 kine tics 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. T he NAS r eview (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 informati on ” in a rul emaking 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 em phasized 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 toxicologic al 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 c onsider 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 proc eeding (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 toxicologi cal 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 d etermining 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 question s the validity of the CIIT URE value and revert s back to the 1991 IRIS assessment value as a default value, stating “ we no longer consider the CIIT URE value health protective, and w e 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

s cientific 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 a ssessment val ue 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 a t 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 thi s process by determining that the only two viable dose

- response values were the CIIT value and the 1991 IRIS value. EPA defaulted to the10 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 2 0 years and determine what constitutes the best available science.

ACC understands that the C onsent D ecree in Sierra Club v. Jackson

, No. 09

- cv

- 00152 SBA (N.D. Cal.)
, imposes a deadline of Oc tober 31, 2011 to sign a final rule promulgating revisions to NESHAP subpart JJ under Clean Air Act ( CAA ) S ection 112(d)(6), or sign a final determination that revision of NESHAP subpart JJ is not necessary under CAA S ection 112(d)(6), and sign a final rul e promulgating residual risk standards for this source category under CAA S ection 112(f)(2), or sign a final determination that promulgation of such standards is not required under CAA S ection 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 th e 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 defe r 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, AC C 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 h as n ot a dequately j ustified p lacing a 400

- p ound c ap on f ormaldehyde u se

Section 112(f)(2) of the CAA requires EPA to promulgate standards to provide “ an ample margin of safety t o 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 80 245. 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 adhesive s. Id. at 80246. EPA contend s that “ it is feasible ... to switch to coatings and adhesives containing no or low11 amounts of formaldehyde at little or no extra cost ...

. ” Id. EPA has not demonstrated, however, that the cap will reduce residual risk and has no t 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 propose d 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, met eorology, and exposure location. Id . at 80229. In addition, EP A 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 thou gh 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 ; s ee also U.S. EPA, Draft Residual Risk Assessme nt 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 ye ars. ” 8 75 Fed. Reg. at 80244. Based on EPA ’ s analysis of both acute and chronic effects, the existing standard s provide an ample margin of safety to protect public health.
Moreover, the proposed 400

- pound cap on formaldehyde use is unlikely to reduce

res idual 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 scie nce, as discussed above, the proposed cap would not lead to any reduction in residual risk.

7 Docket Item EPA

- HQ

- OAR

- 2010

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- 0017

. 8 Cancer incidence would be reduced by 30 percent if EPA were to use the CIIT URE for formaldehyde. 75 Fed. Reg. at 8024 4 n.36.12 103). Further, WHO concluded that becau se 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. Re g. 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]an y 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 co atings 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 addit ion, 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 low

formaldehyde 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 n o

- 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 ne ed 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 w ould 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 tu rn 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 much

needed 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 v alue ; (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 References
Chemical Industry Institute of Toxicology ( CIIT ) . 1999. Formaldehyde: Hazard characterization and dose

- response assessment for carcinogenicity by the route of inhalation (revised ed.).
Conolly, R. B.; Miller, F.J. ; Kimbell, J.S. ; Janszen, D. 2009. Letter to the Editor: Formaldehyde Risk Assessment

. Ann. Occup. Hyg

. 53:181

- 184

. Crump, K .S. ; Chen, C

. ; Fox, J .F.; Van Landingham, C.; Subramaniam, R. 2008. Sensitivity Analysis of Biologically Motivated Model for Formaldehyde

- Induced Respiratory Cancer in Humans

. Ann

. Occup

. Hyg

. 52:481

- 495

. Gaylor, D

. W . and Zheng, Q. 1996

. Effect of the separate and combined administration of mestranol and Phenobarbital on the development of altered hepatic foci expressing placental form of glutathione S

- transfer ase in the rat. Carcinogenesis 17:2043

- 52.

Heck, H . and Casanova, M. 1999. Pharmacodynamics of formaldehyde: applications of a mod e l for the arrest of DNA replication by DNA

- protein cross

- links. Toxicol. Appl. Pharmacol

. 160:86

- 100.

Kimbell, J.S. ; Gross, E .A. ; Joyner, D.R. ; Godo, M.N. ; Morgan, K.T. 1993. Application of computational fl uid dynamics to regional dosimetry of inhaled chemicals in the upper respiratory tract of the rat. Toxicol. Appl. Pharmacol. 121 : 253

- 263.

Kimbell, J.S. ; Overton, J.H. ; Subraman iam, R.P. ; Schlosser, P.M. ; Morgan, K.T. ; Conolly, R.B. ; Miller, F.J. 2001. Dosimetry modeling of inhaled formaldehyde: binning nasal fl ux predictions for quantitative risk assessment

. Toxicol. Sci. 64 : 111

- 121.
National Academy of Sciences ( NAS ) . 2007 . Boar d on Environmental Studies and Toxicology

. Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants. Chapter 5: Formaldehyde, pp. 103

- 138. Available at: http://books.nap.edu/openbook.php?record_id=11170&page=103

. Overton, J.H.; Kimbell, J.S.; Miller, F.J. 2001. Dosimetry modeling of inhaled formaldehyde : the human respiratory tract. Toxicol. Sci. 64 : 122

- 134.

Subramaniam, R.P. ; Richardson, R.B. ; Morgan, K .T. ; Guilmette, R.A. ; Kimbell, J.S. 1998. Computational fl uid dynamics simulations of inspiratory air fl ow in the human nose and nasopharynx. Inhal. Toxicol. 10 : 92

- 120.15 S wenberg, J. A. ; Fryar

- Tita, E. ; Jeong, Y.C. ; Boysen, G. ; Starr, T. ; Walker, V.E. ; Albertin i, R.J. 2008 . Biomarkers in toxicology and risk assessment: Informing critical dose

- response relationships. Chem

. Res

. Toxicol

. 21:253

- 265.

U

. S

. Environmental Protection Agency (U

. S

. EPA)

. 1991. Form aldehyde Risk Assessment Update – Final Draft. Of fi

ce of T oxic Substances, Washington, DC.

U.S. EPA . 1993. Use of IRIS Values in Superfund Risk Assessment
, OSWER Directiv e No. 9285.7

- 16

.
U.S. EPA . 1994. Guidance on the Use of Integrated Risk Information System

. Office of Air Quality Planning and Standards.

World Health Organization (WHO). 2010. WHO Guidelines for Indoor Air Quality . Available at http://www.euro.who.int/__data/assets/pdf_file/0009/128169/e94535.pdf

.