
[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Notices]               
[Page 36504-36511]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn08-46]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2008-0267; FRL-8371-5]

 
Formaldehyde Emissions from Composite Wood Products; Disposition 
of TSCA Section 21 Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On March 24, 2008, 25 organizations and approximately 5,000 
individuals petitioned EPA under section 21 of the Toxic Substances 
Control Act (TSCA) to use section 6 of TSCA to adopt a recently 
promulgated California State regulation concerning emissions of 
formaldehyde from three types of composite wood products: Hardwood 
plywood, particleboard, and medium density fiberboard. They petitioned 
EPA to assess and reduce the risks posed by formaldehyde emitted from 
these products by exercising its authority under TSCA section 6 to: 
Adopt and apply nationally the California formaldehyde emissions 
regulation for these composite wood products; and to extend the 
regulation to include composite wood products used in manufactured 
homes. For the reasons set forth in this notice, EPA has granted in 
part and denied in part the petitioners' requests.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Linter, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: Mary Belefski, Chemical Control 
Division (7405M), Office Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-8461; e-mail address: 
belefski.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons who manufacture, process, 
import, or distribute in commerce composite wood products, including 
hardwood plywood, particleboard, or medium density fiberboard and 
others who are interested in Agency activities involving formaldehyde. 
Since other entities may also be interested, the Agency has not 
attempted to describe all the specific entities that may be interested 
in this action. If you have any questions regarding the applicability 
of this action to a particular entity, consult the technical person 
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Information About This Petition?

    EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2008-0267. All documents in the 
docket are listed in the docket's index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, will be publicly 
available only in hard copy. Publicly available docket materials are 
available electronically at http://www.regulations.gov, or, if only 
available in hard copy, at the OPPT Docket. The OPPT Docket is located 
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room 
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding Federal holidays. The telephone number of the EPA/DC Public 
Reading Room is

[[Page 36505]]

(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

II. Background

A. What is a TSCA Section 21 Petition?

    Section 21 of TSCA allows any person to petition EPA to initiate a 
rulemaking proceeding for the issuance, amendment, or repeal of a rule 
under TSCA section 4, 6, or 8 or an order under TSCA section 5(e) or 
6(b)(2). A TSCA section 21 petition must set forth the facts that are 
claimed to establish the necessity for the action requested. EPA is 
required to grant or deny the petition within 90 days of its filing. If 
EPA grants the petition, the Agency must promptly commence an 
appropriate proceeding. If EPA denies the petition, the Agency must 
publish its reasons for the denial in the Federal Register. A 
petitioner may commence a civil action in a U.S. district court to 
compel initiation of the requested rulemaking proceeding within 60 days 
of either a denial or the expiration of the 90-day period.

B. What Criteria Apply to a Decision on a TSCA Section 21 Petition?

    1. Legal standards regarding TSCA section 21 petitions. Section 
21(b)(1) of TSCA requires that the petition ``set forth the facts which 
it is claimed establish that it is necessary'' to issue the rule or 
order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 implicitly 
incorporates the statutory standards that apply to the requested 
actions. In addition, TSCA section 21 establishes standards a court 
must use to decide whether to order EPA to initiate rulemaking in the 
event of a lawsuit filed by the petitioner after denial of a TSCA 
section 21 petition. 15 U.S.C. 2620(b)(4)(B). Accordingly, EPA has 
relied on the standards in TSCA section 21 and in the provisions under 
which actions have been requested to evaluate this petition.
    2. Legal standard regarding TSCA section 6 rules. In order to 
promulgate a rule under TSCA section 6(a), the Administrator must find 
that ``there is a reasonable basis to conclude that the manufacture, 
processing, distribution in commerce, use, or disposal of a chemical 
substance or mixture . . . presents or will present an unreasonable 
risk.'' 15 U.S.C. 2605(a). This finding cannot be made considering risk 
alone. In promulgating any rule under TSCA section 6(a), the statute 
requires that the Administrator consider:
     The effects of such substance or mixture on health and the 
magnitude of the exposure of human beings to such substance or mixture.
     The effects of such substance or mixture on the 
environment and the magnitude of the exposure of the environment to 
such substance or mixture.
     The benefits of such substance or mixture for various uses 
and the availability of substitutes for such uses.
     The reasonably ascertainable economic consequences of the 
rule, after consideration of the effect on the national economy, small 
business, technological innovation, the environment, and public health.
15 U.S.C. 2605(c)(1).

    Furthermore, the control measure or measures adopted are to be the 
``least burdensome requirements'' that adequately protect against the 
unreasonable risk. 15 U.S.C. 2605(a).
    Section 21(b)(4)(B) of TSCA provides the standard for judicial 
review should EPA deny a request for rulemaking under TSCA section 
6(a): ``If the petitioner demonstrates to the satisfaction of the court 
by a preponderance of the evidence that ... there is a reasonable basis 
to conclude that the issuance of such a rule ... is necessary to 
protect health or the environment against an unreasonable risk of 
injury,'' the court shall order the Administrator to initiate the 
requested action. 15 U.S.C. 2620(b)(4)(B).

C. What Action is Requested Under this TSCA Section 21 Petition?

    On March 24, 2008, the Sierra Club, National Center for Healthy 
Housing, National Coalition to End Childhood Lead Poisoning, Alliance 
for Healthy Homes, National Housing Institute, Healthy Building 
Network, Gulf Coast Environmental Restoration Task Force of Sierra 
Club, Next Generation Choices Foundation, Improving Kids' Environment, 
EarthRose Institute, Grassroots Environmental Education, Healthy Homes 
of Louisiana, Lower Mississippi Riverkeeper, Women's Community Cancer 
Project, Gulf Coast D'Iberville Volunteers Foundation, Advocates for 
Environmental Human Rights, Environmental Health Watch, North Gulfport 
Community Land Trust, Louisiana Environmental Action Network, Allergy 
and Environmental Health Assoc., Aspen River Construction, DeVany 
Industrial Consultant, Protect Sacred Sites ``Indigenous People, One 
Nation,'' United People of the Cherokee Nation, Clean Air Athens, and 
approximately 5,000 individuals petitioned EPA under TSCA section 21. 
The petitioners are concerned about risks to human health from exposure 
to formaldehyde emitted from composite wood products, including 
hardwood plywood, particleboard, and medium density fiberboard. They 
petitioned EPA to assess and reduce these risks by exercising its 
authority under TSCA section 6 to:
    1. Adopt and apply nationally the formaldehyde emissions regulation 
(Airborne Toxics Control Measure (ATCM)) for three types of composite 
wood products (hardwood plywood, particleboard, and medium density 
fiberboard), recently adopted by the California Air Resources Board 
(CARB).
    2. Extend the regulation to include composite wood products used in 
manufactured housing.
    Among other requirements, the CARB ATCM specifies cap emission 
limits that are not to be exceeded.
    In this notice, unless otherwise specified, ``composite wood 
products'' refers to the three types of wood products (hardwood 
plywood, particleboard, and medium density fiberboard) referred to in 
the California regulation. Composite wood products are a subset of 
``pressed wood products.''

D. What Support Do the Petitioners Offer for These Requests?

    To support their request, the petitioners referenced CARB's webpage 
containing the documentation supporting the composite wood products 
rulemaking. In addition, petitioners cited information available from 
Federal agencies including the following:
    1. U.S. Department of Housing and Urban Development (HUD), Office 
of Manufactured Housing Programs, and HUD's formaldehyde emission 
control regulations at 24 CFR 3280.308.
    2. The U.S. EPA National Emission Standards for Hazardous Air 
Pollutants: Plywood and Composite Wood Products at 40 CFR part 63, 
subpart DDDD regulation.
    3. The U.S Occupational Safety and Health Administration, 
Formaldehyde Standards for Toxic and Hazardous Substances, 29 CFR 
1910.1048.
    4. The U. S. Centers for Disease Control and Prevention (CDC) 
analyses and findings on formaldehyde in the Federal Emergency 
Management Agency's (FEMA) Hurricane Katrina trailers. The petitioners 
also

[[Page 36506]]

summarized in their submission the findings on exposure levels from the 
CDC trailer study.

III. Comments Received

    In response to EPA's request for comment on this TSCA section 21 
petition (73 FR 22369, April 25, 2008) (FRL-8362-6), EPA received 25 
comments. Three were short comments in support of the petition from 
concerned citizens and furniture manufacturers; one additional 
furniture manufacturer commented on his concern about effective 
enforcement against furniture importers. Another comment cautioned that 
developing a compliance testing method may be very difficult.
    Eight manufactured housing trade groups and suppliers submitted 
similar comments opposed to EPA regulation of manufactured homes. The 
commenters stated that the HUD's standards have not been shown to be 
inadequate, HUD has the appropriate statutory authority (and EPA should 
use TSCA section 9 to refer the matter to HUD), and HUD has already 
received recommendations to amend its standards. Five furniture, 
window, door, and general manufacturing trade groups indicated their 
support for national application of formaldehyde emission standards, 
but noted that several challenges to the implementation and enforcement 
of California's rule still need to be worked out. Some indicated 
support for EPA development of a ``performance-based standard'' 
designed to reduce human exposure to formaldehyde, regardless of source 
(mentioning carpet and paints as other sources of formaldehyde 
exposure) and all were concerned about the administrative burdens of 
the CARB rule and California's or EPA's ability to manage the 
certification and testing requirements.
    Three plywood and composite panel trade groups indicated support 
for expanding CARB's emission limits to the rest of the United States, 
but commented that a TSCA section 6 rule is neither appropriate nor 
justifiable. They suggest that a national standard would be ``developed 
in a cooperative effort with industry'' rather than through a TSCA 
section 6 rule. The Hardwood Plywood & Veneer Association (HPVA) stated 
that it would be willing to join the Manufactured Housing Institute to 
petition HUD to adopt the CARB standards, and is considering 
incorporating the CARB emission standards into their next revision of 
the American National Standards Institute-HPVA standards for hardwood 
plywood and engineered hardwood flooring. The American Forest & Paper 
Association commented that it ``supports adoption by EPA of the ATCM 
emission standards and testing and labeling provisions as a single, 
national paradigm for formaldehyde in composite wood panels, but 
developed in a cooperative effort with industry rather than through an 
(unjustified) Section 6 rule.'' The Composite Panel Association (CPA) 
estimated that 80% of their members' medium density fiberboard and 
particleboard production will be CARB-compliant, and CPA expects the 
CARB rule to become a de facto national standard. However, since 
compliance with the Phase 2 standards will be significantly more 
expensive, CPA commented that there will be a greater incentive to 
differentiate panel emission level by region or customer. CPA also 
noted that the industry estimates that the costs of the CARB rule, 
nationwide, will be close to $650 million, significantly higher than 
the cost to affected parties predicted by California (commenters stated 
that CARB's cost estimate was $147 million, but it is actually $127 
million). HPVA and CPA also noted concerns about the ability of 
California or the EPA to enforce the regulation against importers of 
panels and finished products, and suggested that imports may be a main 
source of higher emitting panels and finished products.
    Comments were also received from a formaldehyde trade group and 
from a resin manufacturer. Hexion, a ``major global supplier of 
thermosetting adhesives,'' opposed EPA using section 6 to adopt the 
California rule, but ``could support a national, preemptive regulation 
limiting formaldehyde emissions from composite wood products . . .'' 
The Formaldehyde Council, Inc. (FCI) disagreed with the idea that there 
is no safe level of exposure to formaldehyde. FCI also commented that 
the average level detected in the FEMA trailers does not typically 
cause sensory irritation, and cited a study of conventional homes, 
finding an average formaldehyde concentration of 0.37 parts per million 
(ppm) (370 parts per billion (ppb)), in which the occupants had not 
complained of irritation. They also cited studies that show sensory 
irritation thresholds of 0.5 ppm (500 ppb), and up to 0.9 ppm (900 ppb) 
for unsensitized people, and asserted that the empirical support for 
the studies that the International Agency for Research on Cancer (IARC) 
relied on to recategorize formaldehyde has been ``steadily eroded.''
    The Sierra Club commented on the TSCA section 6(c) factors and 
suggested that EPA consider cost factors associated with remediating 
the problems in the FEMA trailers. They suggested that EPA estimate the 
effect on the national economy by a simple mathematic extrapolation 
from the costs estimated by California and argue that adopting the ATCM 
would spur technological innovation and have a positive impact on human 
health and the environment.
    HUD commented that it received (prior to EPA's receipt of this 
petition) a proposal to lower formaldehyde emissions limits from 
certain products used in the construction of manufactured homes from 
the Congressionally established Federal Advisory Committee, the 
Manufactured Housing Consensus Committee (MHCC). In addition, the MHCC 
recently received a new proposal from the public to adopt the CARB 
standard. HUD commented that it will work with the MHCC to review the 
new proposal regarding CARB levels. A supplemental comment was received 
from HUD on June 19, 2008, and is in the docket.
    On June 13, 2008, EPA received an additional comment from CPA, 
summarizing new developments since they submitted their first comment. 
As also noted in their first comment, CPA is accredited by the American 
National Standards Institute (ANSI) as a standards developer. On June 
3, 2008, the CPA Board of Directors ``approved the insertion of the 
CARB Phase 1 and Phase 2 formaldehyde emission limits'' into the new 
versions of the ANSI standards for Particleboard (ANSI A208.1) and for 
Medium Density Fiberboard (ANSI A208.2). When the standards are 
finalized, ``companies would be able to reference either of those 
levels from these voluntary standards in their commercial dealings.'' A 
consensus committee must still approve the revised standard. A 
supplemental comment was also received from HPVA on June 17, 2008, and 
is in the docket.

IV. Disposition of Petition

    For the purpose of making its decision, EPA evaluated the 
information presented or referenced in the petition and its authority 
and requirements under TSCA sections 6 and 21. EPA also evaluated 
comments submitted and relevant information that was otherwise 
available to EPA during the 90-day petition review period. On the basis 
of the significant differences in the legal standards applicable to the 
California Health and Safety Code (H&SC) and TSCA section 6, and the 
insufficiency of the information available to EPA for purposes of 
conducting the TSCA section 6 analysis, EPA is not granting

[[Page 36507]]

the specific request in the petition to commence a proceeding under 
TSCA section 6 to impose the CARB formaldehyde ATCM nationwide. Even if 
the information available to EPA were sufficient to support an 
evaluation of whether formaldehyde in composite wood products presents 
or will present an unreasonable risk, petitioners have not provided 
sufficient information, and EPA does not otherwise have sufficient 
information, to evaluate whether the CARB ATCM would likely be the 
least burdensome alternative necessary to protect adequately against 
such risk. However, EPA has decided to initiate a proceeding to 
investigate whether and what type of regulatory or other action might 
be appropriate to protect against risks posed by formaldehyde emitted 
from pressed wood products.
    The discussion that follows provides the reasons for EPA's 
decisions to grant this petition in part and to deny it in part.

A. EPA is Not Granting the Petitioners' Specific Requests

    1. Differences between California's authority under State law, and 
EPA's authority under TSCA. The petition requests that EPA use 
authorities under section 6 of TSCA to ``adopt the California rules and 
apply them nationally,'' and apply them to composite wood products used 
in manufactured housing (Ref. 1). The authority under which the State 
of California issued its ATCM is quite distinct from the regulatory 
authority granted to EPA under TSCA, however, and EPA has determined 
that its authority under section 6 of TSCA does not permit it to simply 
adopt the California formaldehyde ATCM and impose these regulatory 
controls as a Federal standard without independently determining that 
formaldehyde in the relevant materials presents or will present an 
``unreasonable risk'' under TSCA section 6(a). Neither the CARB 
rulemaking record nor other information available to EPA is adequate to 
support an evaluation of whether the use of formaldehyde in composite 
wood products presents or will present an unreasonable risk.
    CARB's authority to regulate formaldehyde is discussed on pages 2-3 
of CARB's ``Initial Statement of Reasons'' (ISOR), which was used to 
support its rulemaking (Ref. 2). According to the statement of 
authority in the ISOR, CARB asserted jurisdiction to regulate 
formaldehyde in composite wood products under the California H&SC. The 
H&SC authorizes CARB to control emissions of criteria pollutants and 
precursors from source categories. In addition, CARB is authorized to 
regulate toxic air contaminants (TACs) under that portion of the H&SC 
known as the Tanner Act. In 1992, CARB identified formaldehyde as a TAC 
``based primarily on the determination that it was a human carcinogen 
with no known safe level of exposure'' (Ref. 2). According to the ISOR, 
CARB's formaldehyde ATCM was issued principally under the Tanner Act on 
the basis of formaldehyde being a TAC. Because CARB had identified 
formaldehyde as a TAC ``with no identified `safe' threshold exposure 
level,'' it was required by the Tanner Act ``to reduce emissions of the 
TAC to the lowest level achievable through application of BACT (best 
available control technology) or a more effective control method.''
    The TSCA section 6 authority specifically requested by the petition 
to be used to adopt and apply nationally the CARB ATCM is significantly 
different from CARB's authority under the H&SC. As discussed in Unit 
II.B.2., under TSCA section 6(a), EPA must make a finding that there is 
a reasonable basis to conclude that the manufacture, processing, 
distribution in commerce, use, or disposal of a chemical presents or 
will present an unreasonable risk of injury to health or the 
environment in order to promulgate a TSCA section 6(a) rule. The CARB 
rulemaking record does not analyze the issues in these terms because 
CARB does not have to make an unreasonable risk finding under the 
California H&SC.
    TSCA section 6(a) identifies the actions that may be taken to 
protect against unreasonable risk, but does not prescribe a particular 
minimum control measure as California's law prescribes BACT. If EPA 
finds that there is a reasonable basis to conclude that one or more 
activities presents an unreasonable risk, EPA may:
     Prohibit or limit manufacture, processing, or distribution 
in commerce;
     Prohibit or limit the manufacture, processing, or 
distribution in commerce of the chemical above a specified 
concentration;
     Require adequate warnings and instructions with respect to 
use, distribution, or disposal;
     Require recordkeeping;
     Prohibit or regulate any manner of commercial use;
     Prohibit or regulate any manner of disposal; or
     Require manufacturers or processors to give notice of the 
unreasonable risk of injury.
    TSCA section 6(a) also states that EPA must determine which one or 
more of the risk management options set forth in the statute are the 
least burdensome means of adequately protecting against the risk. The 
CARB rulemaking record was constructed to support the single option 
(BACT or more effective control method) available under the California 
H&SC, and not for choosing from the multiple options available under 
TSCA. The California H&SC also does not require that CARB choose the 
least burdensome means of protecting adequately against the risk.
    2. Information in the petition and otherwise available to EPA is 
inadequate to support an unreasonable risk evaluation under TSCA. 
Notwithstanding the substantial amount of information submitted by 
reference with the petition or otherwise available to the Agency, EPA 
has determined that this information is not sufficient to support an 
evaluation of whether formaldehyde emitted from composite wood products 
presents or will present an unreasonable risk to human health 
(including cancer and non-cancer endpoints) under TSCA section 6. 
Applying the TSCA section 6(a) and 6(c) requirements to the information 
provided by the petitioners reveals significant information gaps that 
would need to be filled to support an evaluation of whether use of 
formaldehyde in composite wood products presents or will present an 
unreasonable risk. EPA briefly summarizes its reasoning in this unit.
    a. Health risks and exposure. With respect to health risks, the 
petition refers to the CARB record and to the CDC study on FEMA 
trailers, thus looking at both cancer risk and irritation risk. CARB 
based their health effects evaluation on cancer risk. In 1992, CARB 
identified formaldehyde as a TAC ``based primarily on the determination 
that it was a human carcinogen with no known safe level of exposure'' 
(Ref. 2). CARB also cites for support the higher (hazard) 
classification of formaldehyde as ``Group 1, Carcinogenic to humans'' 
by the International Agency for Research on Cancer (IARC) (Ref. 2, p. 
155, see also Ref. 3). CARB's analysis was dependent on its 
determination of formaldehyde as a human carcinogen and its assumptions 
and analyses that rely on animal data and use two different kinds of 
models, the linearized multi-stage model and a model which takes into 
account the proliferation of premalignant cells, for quantification of 
the cancer risk. In this analysis CARB relied upon the animal data 
considered by EPA in its 1991 analysis and applied an additional model 
which places the result somewhere between that of EPA's 1991 assessment 
and that of the Chemical Industry Institute of

[[Page 36508]]

Toxicology's (CIIT) biologically based dose response (BBDR) approach 
used in EPA in 2004 (discussed in this unit). Given the recent 
availability of human cancer data which may provide the basis of a more 
appropriate quantification of human cancer risk, EPA questions the 
adequacy of the CARB approach and for this reason as well as other 
reasons discussed in this unit, EPA has determined that it is not able 
to rely on CARB's cancer risk assessment.
    EPA has previously assessed formaldehyde's cancer risk. In 1991, 
EPA classified formaldehyde as a B1, probable human carcinogen, ``based 
on limited evidence in humans, and sufficient evidence in animals'' 
(Ref. 4). Increased incidences of nasal squamous cell carcinomas were 
observed in long-term inhalation studies in rats and mice. Based on the 
nasal cavity cancer data in rats and using a linearized multi-stage 
procedure (for genotoxic effects), EPA calculated an inhalation cancer 
unit risk/potency factor of 1.3 E-5 per microgram/meter cubed ([mu]g/
m\3\) (Ref. 4). As explained in this unit, the assessment and modeling 
procedure used to develop EPA's cancer risk assessment is not based on 
the most current information, and EPA may determine that the 
appropriate unit risk/potency factor is higher or lower than the 1991 
value, after considering the currently available scientific 
information, including human data.
    CIIT developed a health risk assessment for formaldehyde based upon 
animal toxicology data that utilized mechanistic and biological 
response information to develop a dose response model for the risk of 
squamous cell carcinoma in the respiratory tract (Ref. 5). The 
resulting BBDR model was published in the peer reviewed literature 
(Refs. 6-8). The cancer estimates obtained with the BBDR model are 
generally 2-3 orders of magnitude lower than corresponding estimates 
obtained with the linearized multistage procedure. In 2004, EPA's 
Office of Air and Radiation (OAR) determined that the CIIT's BBDR model 
was the most appropriate tool to assess the potential cancer risk 
associated with formaldehyde emissions to the atmosphere (Refs. 9-11). 
In the Plywood and Composite Wood Products National Emission Standard 
for Hazardous Air Pollutants (NESHAP), which was issued in 2006, OAR 
stated ``In the case of formaldehyde, we have determined that the 
cancer potency derived using the approach developed by CIIT, which has 
been peer reviewed by an external review panel sponsored by EPA and the 
Canadian government, represents an appropriate alternative to EPA's 
current IRIS URE for formaldehyde. Therefore, this potency represents 
the best available peer-reviewed science at this time.'' (Ref. 10, p. 
8348).
    In April 2008, the EPA Office of Pesticide Programs (OPP) issued a 
preliminary risk assessment of formaldehyde for the reregistration 
eligibility decision (RED) as part of Phase 3 of a modified, 4-Phase 
public participation process that the Agency uses to involve the public 
in developing pesticide reregistration decisions (Ref. 12). Through the 
reregistration program, EPA is ensuring that all pesticides meet 
current health and safety standards under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and 
Cosmetic Act (FFDCA). In this preliminary risk assessment, OPP decided 
to present the formaldehyde cancer risks as a range using both the 1991 
EPA assessment and the CIIT BBDR model (Ref. 15). This approach, which 
recently underwent public comment, brackets a range of cancer risk 
estimates that span about three orders of magnitude (or a factor of a 
thousand), and depending on which value is being considered suggests 
potentially significant risk at one end and potentially insignificant 
risk at the other. In addition to these assessments, IARC, in their 
reevaluation of epidemiologic studies, concluded that there was 
``sufficient epidemiological evidence that formaldehyde causes 
nasopharyngeal cancer in humans,'' and upgraded formaldehyde to ``Group 
1, carcinogenic to humans'' from ``Group 2A, probably carcinogenic to 
humans'' (Ref. 3). In addition, IARC concluded that ``there is strong 
but not sufficient evidence for a causal association between leukemia 
and occupational exposure to formaldehyde'' (Ref. 3). With these new 
human data, and considering the other available data, EPA's Office of 
Research and Development (ORD) is currently engaged in a re-assessment/
update of the potential cancer and non-cancer risks of formaldehyde 
through the ORD Integrated Risk Information System (IRIS) program. An 
external peer review draft of this assessment is expected to be 
released in 2009. EPA offices which may be considering or are actively 
regulating formaldehyde, including the Office of Pollution Prevention 
and Toxic Substances (OPPTS), will coordinate and proceed accordingly 
once the assessment is finalized.
    As discussed previously, because of the uncertainties in estimating 
formaldehyde's cancer risks, and the ongoing development of the science 
with respect to cancer characterization and risk estimation based on 
the new human data, EPA has determined that it cannot rely on the CARB 
cancer assessment and believes it would be premature to render judgment 
on this complex issue for TSCA section 6 purposes. Thus, EPA does not 
believe that it has information sufficient to support an evaluation of 
whether formaldehyde in composite wood products presents or will 
present an unreasonable risk.
    In addition, in the chronic exposure analysis for composite wood, 
the CARB rulemaking record makes assumptions that are not believed to 
be reasonable for use in an EPA risk assessment. For example, CARB 
assumed that individuals will live in new houses (and have associated 
elevated formaldehyde exposures) for 70 years. Their analysis did not 
account for formaldehyde concentration decay over time in new home 
environments, and they assumed all time spent indoors is spent at the 
same average formaldehyde concentration as at home, and that all time 
at home is spent indoors (Ref. 13).
    With respect to irritation risk, the CDC study on FEMA trailers 
cited by petitioners provides data on exposure to formaldehyde in 
trailers, but does not provide a risk analysis. CARB did not rely on 
irritation risks for their decision to regulate formaldehyde emissions 
from composite wood products.
    For these reasons, EPA believes that the information available on 
health risks (including cancer and non-cancer effects) and exposure is 
not adequate to support an unreasonable risk evaluation.
    b. Economics. The economic analysis supporting CARB's ATCM is 
inadequate to support an evaluation of whether formaldehyde in 
composite wood products presents or will present an unreasonable risk. 
In its ISOR, CARB quantified some of the costs and benefits for the 
ATCM, but not all of the costs or any non-cancer benefits.
    The ISOR estimated, for example, the cost for industry to comply 
with the ATCM using various substitute resin systems and discussed the 
characteristics, advantages, and disadvantages of these substitutes, as 
well as their effectiveness in reducing formaldehyde emissions from 
composite wood products. The ISOR cost estimate was based on the cost 
to purchase substitute resins and on the longer processing times 
required to manufacture composite wood products when using certain 
substitute resins. CARB received public comments on its rulemaking that 
companies will incur additional costs to manufacture

[[Page 36509]]

compliant panels due to increased costs for resin additives, new 
equipment, additional energy usage, or decreased throughput. In 
responding to these comments, CARB indicated that these costs would not 
necessarily be incurred, and that it expected future innovations in 
resin technology would decrease production costs over time. EPA 
suspects that the CARB analysis underestimated costs, particularly in 
the short term. But EPA was not able to assess the full extent of the 
likely costs based on the information available. For example, the ISOR 
cost estimate also does not fully reflect other requirements of the 
ATCM, such as third party certification and labeling. In addition, 
because data were not available on the quantity of composite wood 
contained in imported fabricated goods such as cabinets and furniture, 
the ISOR cost estimates did not reflect the increase in the cost of 
these goods. Thus, the information submitted provides an inadequate 
basis for assessing total incremental cost for the ATCM, or for a 
national version of the ATCM, including certification, labeling, and 
related activities required by the ATCM.
    The trade associations representing composite wood product 
manufacturers have indicated that the CARB limits may have a 
significant impact on the national markets. For example, CPA estimated 
that 80% or more of its members' production nationwide will be 
compliant with CARB's requirements. The associations indicated, 
however, that they could not estimate how foreign manufacturers and 
importers will respond to the ATCM and that off-shore producers are an 
issue because they do not participate in the same voluntary compliance 
programs that are applicable to domestic producers. Furthermore, 
especially in view of the expected growth in imports of composite wood 
products and the fabricated goods made from them, the national baseline 
following the implementation of the CARB rule, which EPA would use as a 
starting basis in assessing whether there is an unreasonable risk, is 
uncertain (Ref. 13).
    In addition to cancer benefits, the ATCM may result in benefits 
from avoided cases of non-cancer effects. The CARB ISOR does not, 
however, present sufficient information to assess benefits from non-
cancer effects. For example, the CARB ISOR mentions a hazard quotient 
for non-cancer inhalation impacts, but the hazard quotient was not 
evaluated to estimate the number of people exposed to a hazard quotient 
above 1, the aggregate length of time that such exposures occur, and 
the intensity of the exposure over time. In addition, the ISOR did not 
provide information on the size of the population exposed or the 
intensity of exposure from composite wood products in remodeled homes, 
newly purchased furniture, or non-residential settings. The benefits of 
avoiding irritation effects include reductions in medical costs, 
individuals' willingness to pay to avoid the pain and suffering 
resulting from these effects, and increases in productivity due to a 
decline in lost work days and school days. The ISOR and the other 
information available to EPA does not provide sufficient information to 
estimate the non-cancer benefits.
    Thus, EPA does not have sufficient information to support an 
evaluation of the costs and benefits of implementing the ATCM 
requirements nationwide.
    3. Information in the petition and otherwise available to EPA is 
insufficient to support an evaluation of whether the CARB rule would be 
the least burdensome requirement under TSCA. Even if the information 
available to EPA were sufficient to support an evaluation of whether 
formaldehyde in composite wood products presents or will present an 
unreasonable risk, petitioners have not provided sufficient 
information, and EPA does not otherwise have sufficient information, to 
evaluate whether the CARB ATCM would likely be the least burdensome 
alternative necessary to protect adequately against such risk. The 
information submitted with the petition does not provide an adequate 
basis for EPA to evaluate the likely costs and benefits of less 
burdensome alternatives. This is not surprising, since the CARB 
rulemaking does not require such an analysis. For example, EPA has no 
basis to evaluate whether the specific emission levels adopted by CARB 
would be appropriate levels under TSCA section 6, whether CARB's cap 
approach or an average emissions approach would be more appropriate, or 
whether the additional detailed requirements pertaining to third-party 
certification and other issues would be appropriate. Several aspects of 
the CARB ATCM are not in place yet, and EPA is not able to evaluate 
those aspects. Beyond that, it is entirely possible that some control 
measure(s) other than the emission cap approach that CARB selected for 
their ATCM would be appropriate. Especially in view of estimates in the 
record of nationwide compliance with the ATCM, EPA would want to assess 
the risk that was likely to remain following compliance with the rule 
and assess whether one or more of the options under TSCA section 6(a) 
was more appropriate to address the remaining risk.
    In summary, information in the petition and otherwise available to 
EPA, including health effects, exposure, and economic information, is 
inadequate to support an evaluation of whether there is an unreasonable 
risk under TSCA. Therefore, EPA is not granting the specific request in 
the petition to commence a proceeding under TSCA section 6 to impose 
the CARB formaldehyde ATCM nationwide.

B. Additional Considerations

    Pressed wood products, of which the three composite wood products 
regulated by CARB are a subset, are a major source of formaldehyde 
concentrations. Other sources of formaldehyde include smoking, 
household products, and the use of un-vented, fuel-burning appliances 
like gas stoves or kerosene space heaters (Refs. 16 and 17). 
Formaldehyde emissions from pressed-wood products are the highest when 
these products are new and decline over time. Emissions of formaldehyde 
will increase as the temperature, humidity, and pressed wood surface 
area increase (Ref. 13).
    Several Federal agencies and other entities have regulated or 
produced guidelines on appropriate air concentrations of formaldehyde. 
HUD presently limits formaldehyde emissions from plywood and 
particleboard used in manufactured home construction to 200-300 ppb, 
and is reviewing proposals to revise those emission limits. Among 
others, the Agency for Toxic Substances and Disease Registry (ATSDR) 
has established a Minimal Risk Level (MRL) chronic value of 0.008 ppm/
8ppb; the National Institute for Occupational Safety and Health (NIOSH) 
has established a Recommended Exposure Limit (REL) of 0.016 ppm/16ppb 
(8-hour Time Weighted Average), and of 0.1 ppm/100ppb (15 minute 
ceiling); and American Conference of Governmental Industrial Hygienists 
(ACGIH) has established threshold limit value (TLV)-Ceiling of 0.3 ppm/
300 ppb (Ref. 13).
    In March 2008, several Federal agencies, including the Department 
of Health and Human Services (HHS), CDC, U.S. Department of Homeland 
Security (DHS), FEMA, and EPA finalized a document entitled: 
``Formaldehyde Exposure in Homes: A Reference for State Officials to 
Use in Decision-making,'' which summarizes the environmental health 
related aspects of formaldehyde exposure in homes and references the 
government standards in occupational settings (Ref. 14).

[[Page 36510]]

    Foreign governments, including Japan and the European Union, have 
also regulated permissible levels of formaldehyde emissions from 
composite wood products and other building materials (Ref. 2).
    EPA previously assessed formaldehyde's cancer risk based on the 
nasal cavity cancer data in rats and using a linearized multi-staged 
procedure (for genotoxic carcinogens) (Ref. 4). EPA is conducting a re-
assessment/update of the potential cancer risks of formaldehyde through 
the Integrated Risk Information System (IRIS) process that will 
consider current human data and other data.
    Depending on concentration, it is well recognized that formaldehyde 
can be an eye, nose, and throat irritant, even when exposure is of 
relatively short duration. In the indoor environment, sensory reactions 
and various symptoms as a result of mucous membrane irritation are 
potential effects, and, while there are large individual differences in 
the general population, the differences are even greater when hyper-
reactive and sensitized people are included in an analysis. EPA 
acknowledges that there are uncertainties relating to irritation 
response levels in humans.
    In light of information about the hazards of formaldehyde, in 
combination with the potential for prolonged exposure to potentially 
problematic levels of formaldehyde by residents in newly constructed 
housing (Ref. 13), EPA believes it is appropriate, in the Agency's 
discretion, to initiate a proceeding to better understand the risks 
from formaldehyde in pressed wood products (including the three types 
of composite wood regulated by CARB) and to assess various alternatives 
that EPA might pursue to address such risks. Most of the exposure 
information presently available to EPA pertains to formaldehyde 
emissions from pressed wood products in newly built homes (Ref. 13). 
While emissions from pressed wood products used in new home 
construction are themselves significant sources of formaldehyde in 
indoor air, EPA is interested in what other pressed wood sources 
contribute significantly to formaldehyde concentrations in indoor air. 
For example, large renovations projects in existing homes, which 
include a large amount of new pressed wood products, and 
microenvironments, such as baby cribs built with pressed wood products, 
could be important sources of exposure to a large number of children 
and adults.
    The available information, guidelines, and regulations span a wide 
range of permissible formaldehyde levels. EPA believes that it is 
appropriate to examine these various standards, analyze the risk level 
for formaldehyde in pressed wood products, and determine the 
appropriate course of action to reduce risks to human health.

C. EPA's Decision to Initiate a Proceeding to Investigate Formaldehyde 
in Pressed Wood Products

    In sum, the petition does not, as required under TSCA section 21, 
set forth facts sufficient to establish that it is necessary to 
initiate a proceeding under TSCA section 6(a) to protect human health 
against an unreasonable risk of injury by applying the CARB regulation 
on a national basis. Further, the additional relevant information that 
EPA has identified does not support initiation of the requested 
proceeding. However, after considering the facts presented by the 
petitioners (including the California administrative record), 
information presented by commenters, and other information available to 
EPA, EPA has decided to initiate a proceeding to investigate whether 
and what type of regulatory or other action might be appropriate to 
protect against risks posed by formaldehyde emitted from pressed wood 
products.
    In parallel with this effort, EPA's ORD will be developing and 
obtaining external peer review for the IRIS assessment of 
formaldehyde's cancer and non-cancer risks. OPPTS will coordinate with 
ORD and other EPA offices as it evaluates risks and options under TSCA, 
and the results of the IRIS effort will be incorporated into this 
proceeding if timely available. In addition, the preliminary risk 
assessment used in the Pesticide Reregistration Program will be 
considered in the effort to evaluate risks and options under TSCA if 
timely available, and OPP will also consider the efforts under TSCA, as 
well as other efforts.
    In Fall 2008, EPA plans to issue an advance notice of proposed 
rulemaking (ANPR) to initiate a proceeding. As part of the ANPR 
process, EPA will engage stakeholders to contribute to obtaining a 
better understanding of the available control technologies and 
approaches, industry practices, and the implementation of CARB's ATCM. 
Concurrently, EPA plans to develop and conduct an industry survey and 
initiate development of an exposure assessment and an irritation 
concern level that could be used for evaluating emissions standards or 
other approaches. Subsequently, EPA plans to develop an irritation risk 
assessment, which will receive the appropriate external review, and 
quantify costs and benefits. At the conclusion of this work, OPPTS 
anticipates determining whether it should take action, which may 
include action under TSCA section 6(a) or TSCA section 6(b), or via the 
development of a voluntary consensus standard or other approaches. As 
OPPTS evaluates risks and options under TSCA, OPPTS intends to 
coordinate its efforts with other interested EPA offices and agencies, 
as well as engage the public and stakeholders.
    With respect to the petitioners' request that EPA use TSCA section 
6 to apply the CARB rule to manufactured homes, EPA notes that HUD has 
regulations governing formaldehyde emission levels from plywood and 
particleboard materials installed in manufactured homes. (See 24 CFR 
3280.308.) HUD is in the process of reviewing proposed changes to these 
regulations to include medium density fiberboard, among other things. 
HUD is also currently reviewing a proposal to amend its manufactured 
housing regulations governing formaldehyde to include the standards set 
forth in the CARB regulation. Section 9(d) of TSCA provides that the 
Administrator of EPA shall consult and cooperate with other Federal 
agencies ``for the purpose of achieving the maximum enforcement of 
[TSCA] while imposing the least burdens of duplicative requirements.'' 
15 U.S.C. 2608(d). Consistent with this provision, EPA will consult and 
cooperate with HUD as the two agencies work to address formaldehyde 
emissions from composite wood products.

V. References

    The following is a list of the documents that are specifically 
referenced in this notice and placed in the docket that was established 
under Docket ID number EPA-HQ-OPPT-2008-0267. For information on 
accessing these documents in the docket, refer to Unit I.B. Some 
documents may also be accessed directly using the url provided.
    1. Sierra Club, 25 other organizations, and approximately 5,000 
individuals. Letter from Tom Neltner, Sierra Club, to Stephen Johnson, 
Administrator, Environmental Protection Agency. Re: Citizen Petition to 
EPA Regarding Formaldehyde in Wood Products. March 20, 2008.
    2. California Environmental Protection Agency Air Resources Board. 
Proposed Airborne Toxic Control Measure to Reduce Formaldehyde 
Emissions from Composite Wood Products, Staff Report: Initial Statement 
of Reasons for Proposed Rulemaking. March 9, 2007. http://
www.arb.ca.gov/

[[Page 36511]]

regact/2007/compwood07/compwood07.htm.
    3. International Agency for Research on Cancer (IARC). 
Formaldehyde. IARC Monographs on the Evaluation of Carcinogenic Risks 
to Humans. International Agency for Research on Cancer. Lyon, France. 
Meeting on June 2-9, 2004, as published by IARC in 2006. Vol. 88. 
http://monographs.iarc.fr/ENG/Monographs/vol88/index.php.
    4. EPA, Office of Research and Development. Formaldehyde. 
Integrated Risk Information System. 1991. http://www.epa.gov/iris/
links.htm.
    5. Chemical Industry Institute of Toxicology (CIIT). Formaldehyde 
hazard characterization and dose-response assessment for 
carcinogenicity by the route of inhalation, revised ed. Chemical 
Industry Institute of Toxicology, Research Triangle Park, NC. 1999.
    6. Conolly, R.B., Kimbell, J.S., Janszen, D., and Miller, F., J. 
Dose-response for formaldehyde-induced cytotoxicity in the human 
respiratory tract. Regulatory Toxicology and Pharmacology. 35: 32-43. 
2002.
    7. Conolly, R.B., Kimbell, J.S., Janszen, D., Schlosser, P.M., 
Kalisak, D., Preston, J., and Miller, F., J. Biologically-motivated 
computational modeling of formaldehyde carcinogenicity in the F344 rat. 
Toxicological Sciences. 75:432-447. 2003.
    8. Conolly, R.B., Kimbell, J.S., Janszen, D., Schlosser, P.M., 
Kalisak, D., Preston, J., and Miller, F., J. Human respiratory tract 
cancer risks of inhaled formaldehyde: Dose-response predictions derived 
from biologically-motivated computational modeling of a combined rodent 
and human dataset. Toxicological Sciences. 82: 279-296. 2004.
    9. EPA. National Emission Standards for Hazardous Air Pollutants: 
Plywood and Composite Wood Products; Effluent Limitations Guidelines 
and Standards for the Timber Products Point Source Category; List of 
Hazardous Air Pollutants, Lesser Quantity Designations, Source Category 
List; Final Rule. Federal Register (69 FR 45943, July 30, 2004) (FRL-
7634-1). http://www.epa.gov/ttn/atw/plypart/fr30jy04.pdf.
    10. EPA. National Emission Standards for Hazardous Air Pollutants: 
Plywood and Composite Wood Products; List of Hazardous Air Pollutants, 
Lesser Quantity Designations, Source Category List; Final Rule. Federal 
Register (71 FR 8341, February 16, 2006) (FRL-8028-9). http://
www.epa.gov/ttn/atw/plypart/fr16fe06.pdf.
    11. EPA. National Emission Standards for Hazardous Air Pollutants: 
Plywood and Composite Wood Products; Final Rule. Federal Register (72 
FR 61060, October 29, 2007) (FRL-8482-2). http://www.epa.gov/ttn/atw/
plypart/fr29oc07.pdf.
    12. EPA. Formaldehyde/Paraformaldehyde Risk Assessments; Notice of 
Availability and Risk Reduction Options; Notice. Federal Register (73 
FR 21944, April 23, 2008) (FRL-8360-3). http://www.epa.gov/fedrgstr/
EPA-PEST/2008/April/Day-23/p8684.htm.
    13. EPA. Background Document of Technical Information Relevant to 
the Disposition of the TSCA Section 21 Petition on Formaldehyde. June 
2008. Docket ID number EPA-HQ-OPPT-2008-0267.
    14. Department of Health and Human Services, Centers for Disease 
Control and Prevention, Department of Homeland Security, Federal 
Emergency Management Agency, and EPA. Formaldehyde Exposure in Homes: A 
Reference for State Officials to Use in Decision-Making. March 2008. 
http://www.cdc.gov/nceh/ehhe/trailerstudy/compendium.htm.
    15. EPA. Formaldehyde: Preliminary Risk Assessment for the 
Registration Eligibility Decision (RED). DP Barcode: 348474, April 7, 
2008. Docket ID number EPA-HQ-OPP-2008-0121. http://
www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-
HQ-OPP-2008-0121.
    16. CPSC. 1997. An Update On Formaldehyde: 1997 Revision. Consumer 
Product Safety Commission, Washington, DC, CPSC Doc. 725 
http://www.cpsc.gov/cpscpub/pubs/725.html.
    17. EPA. 2007. Indoor Air Quality (IAQ), Pollutants and Sources of 
Indoor Air Pollution, Formaldehyde/Pressed Wood Products, Office of 
Radiation and Indoor Air (ORIA), Indoor Environments Division, 
Washington, DC, Updated November 14, 2007. http://www.epa.gov/iaq/
formalde.html#Levels%20in%20Homes.

List of Subjects

    Environmental protection, Composite wood products, Formaldehyde, 
Housing, Toxic Substance Control Act (TSCA).


    Dated: June 21, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E8-14618 Filed 6-26-08; 8:45 am]

BILLING CODE 6560-50-S
