[Federal Register: December 21, 2007 (Volume 72, Number 245)]
[Notices]
[Page 72885-72896]
[DOCID:fr21de07-143]

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Part IV

Environmental Protection Agency

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Air Fresheners; TSCA Section 21 Petition; Notice

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-1016; FRL-8345-9]

Air Fresheners; TSCA Section 21 Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On September 20, 2007, the Sierra Club, the National Center
for Healthy Housing, the Alliance for Healthy Homes, and the Natural
Resources Defense Council (NRDC) petitioned EPA under section 21 of the
Toxic Substances Control Act (TSCA) to: Call-in allegations of adverse
reactions related to air freshener products recorded by manufacturers
and processors pursuant to TSCA section 8(c) and 40 CFR part 717; adopt
a rule pursuant to TSCA section 8(d) to require submittal of heath and
safety studies related to air fresheners, including lab results of
ingredients and health effects from respiratory exposures; adopt a rule
pursuant to TSCA section 4 to require manufacturers to conduct acute
and chronic studies to evaluate the impact of air fresheners on human
health; and adopt a rule pursuant to TSCA section 6 to require that air
fresheners be labeled to identify all of their ingredients. TSCA
section 21 does not apply to the petitioners' request for a call-in
under TSCA section 8(c), and, for the reasons set forth in this notice,
EPA has denied the petitioners' remaining three requests.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, 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:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
     For technical information contact: Robert Jones, Chemical Control
Division (7405M), Office Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture,
process, import, or distribute in commerce air fresheners or their
ingredients. Potentially affected entities may include, but are not
limited to:
     Chemical manufacturers (including importers) and
processors (NAICS code 325), e.g., air and room freshener
manufacturers.
     Other manufacturers (including importers) and processors
(NAICS code 3399), e.g., manufacturers of potpourri.
     This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the TSCA section 21 petition on air fresheners. 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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2007-1016. 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<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. 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.
     2. Electronic access. You may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr.

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 standard 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 8(d) rules. Section 8(d)
of TSCA authorizes EPA to require the submission of unpublished health
and safety studies initiated or conducted by, or known to or reasonably
ascertainable by, manufacturers, processors, and distributors of
chemical substances or mixtures. Studies may be excluded ``if the
Administrator finds that submission of lists of such studies are
unnecessary to carry out the purposes of [TSCA].'' 15 U.S.C.
2607(d)(1).

    Section 21(b)(4)(B) of TSCA provides the standard for judicial
review should EPA deny a request for rulemaking under TSCA section
8(d): ``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).
    3. Legal standard regarding TSCA section 4 rules. EPA must make
several findings in order to issue a rule to require testing under TSCA
section 4. In all cases, EPA must find that data and experience are
insufficient to reasonably determine or predict the effects of a
chemical or mixture on health or the environment and that testing of
the chemical is necessary to develop the missing data. 15 U.S.C.
2603(a)(1). In addition, EPA must find either that the chemical or
mixture may present an unreasonable risk of injury or that the chemical
is produced in substantial quantities and may either result in
significant or substantial human exposure or result in substantial
environmental release. Id.
    In the case of a mixture, EPA must also find that ``the effects
which the mixture's manufacture, distribution in commerce, processing,
use, or disposal or any combination of such activities may have on
health or the environment may not be reasonably and more efficiently
determined or predicted by testing the chemical substances which
comprise the mixture.'' 15 U.S.C. 2603(a)(2).
    If EPA denies a petition for TSCA section 4 rulemaking and the
petitioners challenge that decision, TSCA section 21 allows a court to
order EPA to initiate rulemaking if the petitioner demonstrates to the
satisfaction of the court by a preponderance of the evidence in a de
novo proceeding that findings very similar to those described in this
unit with respect to a chemical substance have been met. However, TSCA
section 21 omits the finding that ``testing is necessary to develop the
data'' from the findings that a petitioner must demonstrate in order
for a court to require EPA to initiate TSCA section 4 rulemaking. 15
U.S.C. 2620(b)(4)(B)(i). Nonetheless, EPA believes TSCA section
21(b)(4) is best interpreted as incorporating this finding. The
alternative would be to read the statute as empowering a court to
require EPA to initiate a rulemaking even where the Agency could not
make proposed findings consistent with TSCA section 4 or take final
action on the rule. EPA's interpretation is supported by legislative
history. House Conference Report 94-1679 at pp. 97-99 (1976).
    In addition, EPA believes TSCA section 21(b)(4) does not provide
for judicial review of a petition to promulgate a test rule for
mixtures. Section 21(b)(4)(B)(i) of TSCA specifies that the court's
review pertains to application of the TSCA section 4 factors to
chemical substances. Moreover, TSCA section 21(b)(4)(B)(i) does not
contain the additional finding that TSCA section 4 requires for issuing
a test rule for mixtures (that the effect may not be reasonably and
more efficiently determined or predicted by testing the chemical
components). Congress left the complex issues associated with the
testing of mixtures to the Administrator's discretion.
    4. Legal standard regarding TSCA section 6 rules. In order to
promulgate a rule under TSCA section 6, 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 adopted is to be the ``least
burdensome requirement'' that adequately protects 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 September 19, 2007, the Sierra Club, the National Center for
Healthy Housing, the Alliance for Healthy Homes, and NRDC petitioned
EPA to:
    1. Call-in allegations of adverse reactions related to air
freshener products recorded by manufacturers and processors pursuant to
TSCA section 8(c) and 40 CFR part 717.
    2. Adopt a rule pursuant to TSCA section 8(d) to require submittal
of health and safety studies related to air fresheners, including lab
results of ingredients and health effects from respiratory exposures.
    3. Adopt a rule pursuant to TSCA section 4 to require manufacturers
to conduct acute and chronic studies to evaluate the impact of air
fresheners on human health.
    4. Adopt a rule pursuant to TSCA section 6 to require that air
fresheners be labeled to identify all of their ingredients (Ref. 1).
    The petition defined air fresheners as:

    ...a broad range of product types, from traditional sprays to
outlet- and battery-operated plug-ins, solid gel dispensers, hanging
car air fresheners and potpourri. Air fresheners can serve two
purposes: odor control (which includes unscented air fresheners) and
aesthetic scent. Some products may serve both purposes, and others
may serve only one. Cleaning products that kill germs, clean
surfaces and leave a pleasant fragrance are not included in these
petitions.
(Ref. 1)

    The petitioners also simultaneously petitioned the Consumer Product
Safety Commission (CPSC) under the Federal Hazardous Substances Act
(FHSA) (15 U.S.C. 1261 et seq.) ``to undertake specific actions to
assess fully the risk to the public from exposure to air fresheners and
to take reasonable steps to reduce that risk'' (Ref. 1). In November
2007, the CPSC declined to docket the petition for rulemaking, because
it did not meet the CPSC's statutory or regulatory requirements (Ref.
2). CPSC stated that it was rejecting the petition because the petition
did not ``identify the specific toxic constituent(s) and their
concentration(s) in the air fresheners, the mechanism of exposure and/
or uptake of each such constituent or the `substantial illness' that
might result from customary or reasonably foreseeable handling or use
of such air fresheners that contain each

of these substances.'' CPSC also found that the petition did not
``provide[] sufficient information to establish that a rule is
necessary.''

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

    Petitioners are concerned about potential risks from air fresheners
and believe EPA should take the requested actions to assess and reduce
any such risks. The petition discusses at length three reports in
support of these requests:
     The American Association of Poison Control Centers'
(AAPCC) 2005 Annual Report (Ref. 3).
     An ``opinion'' issued in January 2006 by the European
Commission's Scientific Committee on Health and Environmental Risks
(SCHER) (Ref. 4) on a report issued in January 2005 by the Bureau
Europ[eacute]en des Unions de Consommateurs (BEUC), which measured and
assessed chemical emissions from 74 air fresheners sold in Europe (Ref.
5).
     A report issued in September 2007 by NRDC on the presence
of phthalate esters in air fresheners (Ref. 6).
    1. Association of Poison Control Centers (AAPCC) Report. In support
of the assertion that air fresheners present ``a significant source of
human exposure to a veritable cocktail of dangerous and potentially
dangerous'' chemicals, the petition presents information drawn from the
AAPCC 2005 Annual Report. EPA considered the AAPCC report and does not
agree with the petitioners that the information in the report raises
significant concerns about possible health effects of air fresheners.
    According to the petition (Ref. 1), the AAPCC reported the
following ``exposures'' to air fresheners based on calls to local
poison control centers in 2005: 14,094 people overall (including 11,800
children younger than 6). Of the reported exposures, the petition
indicates that 98% were unintentional, and 2,623 resulted in injuries
(2,492 minor injuries; 125 moderate injuries; 5 major injuries; and 1
death).
    These numbers, however, represent only a very small percentage
(0.58%) of the total number of 2,424,180 exposures to all substances
reported in the AAPCC's 2005 Annual Report (Ref. 3). This incidental
percentage is the more striking considering the industry's assertion
that 70% of U.S. homes use air fresheners (Ref. 7) and the petitioners'
assertion that ``[a]lmost every American is exposed to air fresheners
in some manner'' (Ref. 1). Moreover, according to the 2005 AAPCC
report, only 32 (0.23%) of the 14,094 reported air freshener exposures
involved an adverse reaction, which is defined by AAPCC as ``an adverse
event occurring with normal, prescribed, labeled, or recommended use of
the product, as opposed to overdose, misuse, or abuse'' (Ref. 3).
    Considering the widespread use of air fresheners, the number of
reported exposure incidents for air fresheners is relatively small when
compared to the reported exposure incidents for other product
categories. In the AAPCC report, air fresheners are one of five
subcategories of deodorizers, and deodorizers have among the lowest
number of reported exposures and injuries among the 55 categories in
the AAPCC report (Refs. 3 and 8). In the AAPCC report, deodorizers are
not included in the list of 23 categories ``most frequently involved in
human exposures'' (Refs. 3 and 8). Deodorizers are 20\th\ among 23
categories for ``most frequently involved in pediatric exposures
(children younger than 6 years),'' but deodorizers were involved in
only 1.3% of the total number of such exposures (Ref. 3). (The
percentages for the 21\st\ (asthma therapies), 22\nd\ (dietary
supplements/herbals/homeopathic), and 23\rd\ (antidepressants)
categories were 1.2%, 1.1%, and 1.1%, respectively, nearly the same as
for deodorizers). Nearly 95% of the injuries resulting from air
freshener exposures were minor, 4.8% were moderate, and only 0.2% (5)
were major. Of the two deaths reported, one resulted from intentional
misuse and the reason for the other was reported as ``unknown'' (Refs.
3 and 8).
    The petitioners assert that these figures under-represent exposures
because people may not recognize the relationship asserted by the
petitioners between air freshener exposures and adverse effects (Ref.
1). On the other hand, EPA recognizes that asthma attacks and other
health effects may be incorrectly attributed by callers to air
freshener exposures. EPA has no basis to draw conclusions based on the
possibility of unreported exposures to air fresheners or any other
products. It is also important to note that these exposure reports,
which provide the basis for the AAPCC report, rarely, if ever, include
information about the concentrations or durations of the reported
exposures and, therefore, cannot be used to make any conclusions about
actual exposures during use or long-term health risks (Ref. 9).
    2. NRDC Report. According to the petition, NRDC tested 14 air
fresheners and found phthalate esters in 12 (Ref. 6). NRDC stated that
none of these 12 air fresheners listed phthalate esters as ingredients
on their labels. According to the petition, phthalate esters are
associated with ``a number of reproductive health risks'' and with
allergic symptoms and asthma. The petitioners also state that
``California's Office of Environmental Health Hazard Assessment lists
some phthalates (including some found in these air fresheners) as
chemicals known to the state to cause reproductive toxicity under
California's Proposition 65'' (Ref. 1).
    Phthalate esters are a broad category of chemicals with varying
toxicological profiles. California Proposition 65 (the Safe Drinking
Water and Toxic Enforcement Act of 1986) requires the State to publish
a list of chemicals known to be carcinogens or developmental toxicants
and requires businesses to provide public notice about any
``significant'' amount of a listed chemical in their products by, among
other methods, labeling a consumer product (http://www.oehha.ca.gov/prop65.html
) (Ref. 11). Of the five phthalate esters on the Proposition

65 list, only one (di-n-butyl phthalate (DBP)) was reported in the NRDC
study as being detected in air fresheners. According to the U.S.
Centers for Disease Control Third National Report on Human Exposure to
Environmental Chemicals, many consumer products contain phthalate
esters, including vinyl flooring, adhesives, detergents, lubricating
oils, solvents, automotive plastics, plastic clothing (e.g.,
raincoats), personal-care products (e.g., soap, shampoo, deodorants,
fragrances, hair spray, nail polish), medical pharmaceuticals, plastic
bags, garden hoses, inflatable recreational toys, blood-storage bags,
intravenous medical tubing, and children's toys (Ref. 10).
    The NRDC study tested for 15 phthalate esters (including 4 of the 5
phthalate esters on the Proposition 65 list) and found one or more of 5
phthalate esters (including 1 (DBP) on the Proposition 65 list) in 12
of 14 air freshener products tested. The 5 phthalate esters were: Di-n-
butyl phthalate (DBP), CAS No. 84-74-2; diethyl phthalate (DEP), CAS
No. 84-66-2; diisobutyl phthalate (DIBP), CAS No. 84-69-5; diisohexyl
phthalate (DIHP), CAS No.146-50-9; and dimethyl phthalate (DMP), CAS
No. 131-11-3 (Ref. 6).
    With the exception of DEP, the phthalate esters were detected at
very low concentrations (less than 7 parts per million (ppm)), which
might indicate their presence as an impurity or lab contaminant rather
than as an intentional ingredient. DBP was the only phthalate ester on
the California Proposition 65 list (where it is listed for

developmental toxicity) detected in the air fresheners examined in the
NRDC report. DBP was detected at very low concentrations in 5 samples:
At concentrations less than 1 ppm in four samples and at a
concentration of 4.5 ppm in one sample.
    DEP was detected in three samples at concentrations of 360 ppm,
1,100 ppm, and 7,300 ppm; DEP was detected in six other samples at
concentrations of 6.3 ppm or less (Ref. 6). DEP is known to be used as
a solvent and vehicle in a wide variety of fragrance and cosmetic
products at concentrations ranging from < 0.1% to 11% (i.e., 1,000 to
110,000 ppm) (Ref. 29), which could explain its detection at
concentrations in the thousands of ppm in several air fresheners
reported by NRDC. While higher than the very low levels of other
detected phthalate esters, the levels of DEP in air fresheners
identified in the NRDC Report are still quite low. In 2003, the
European Union's (EU) Scientific Committee on Cosmetic Products and
Non-Food Products Intended for Consumers (SCCNFP), a scientific
advisory body to the European Commission (as is the EU's SCHER that is
cited by the petitioners), concluded that the safety profile of DEP
supports its use in European cosmetic products at ``current levels''
(Refs. 12 and 13).
    The petitioners also referenced several studies in footnotes within
the petition and in a public comment that reported possible
associations between general exposure to phthalate esters (i.e., not
specifically from exposure to air fresheners) and potential adverse
health effects in humans. The NRDC report did not measure nor estimate
the potential exposures or risks that may result from the use of air
fresheners in which phthalate esters have been detected and so does not
provide a basis to assess such exposure or potential risk. There are
numerous other potential sources of phthalate esters to which consumers
may be exposed that could lead to potentially higher exposures than
those that may result from use of air fresheners.
    In 2007, following release of a report by Greenpeace that reported
concentrations of phthalate esters in perfumes (Ref. 14), the EU's
Scientific Committee on Consumer Products (SCCP) issued an opinion on
certain phthalate esters in cosmetic products (Ref. 15). The SCCP
opinion addressed nine phthalate esters including four of the five
phthalate esters detected in air freshener samples by NRDC. The
magnitude of the phthalate ester concentrations reported in the
Greenpeace report for perfumes are similar to those reported by NRDC.
DIHP, detected by NRDC at a concentration of 2.1 ppm in one air
freshener, was not included in the SCCP opinion. The SCCP concluded
that: There was no need to update the SCCNFP opinion on the safe use of
DEP in cosmetics; in view of the low concentrations of DIBP and DMP
found in samples analyzed (38 and 2,982 ppm, respectively), there would
be no quantifiable risk for the consumer; and that traces of DBP up to
100 ppm do not indicate a risk to the health of the consumer.
Similarly, the Cosmetic Ingredient Review Expert Panel concluded in
2002/2003 that DBP, DMP, and DEP are safe for use in cosmetic products
(including perfumes and hair sprays) ``in the present practices of use
and concentrations'' (Ref. 29).
    EPA recently contracted with the National Academy of Sciences (NAS)
to evaluate human health risks and the potential for conducting a
cumulative risk assessment for phthalate esters (Ref. 16). (Project
information is available at http://www8.nationalacademies.org/cp/projectview.aspx?key=48860
). Specifically, EPA is eliciting external

expert consultation to evaluate the issues related to cumulative hazard
and dose-response assessment. The study panel will examine the
strengths and limitations of a cumulative approach opposed to or in
addition to an individual chemical approach for risk assessment of
phthalates. EPA anticipates that the final product of this study panel
will be a report discussing the issues identified by the panel, the
ways in which any assessment may be approached, the strengths and
limitations of any of the proposed approaches, and whether any
additional research is needed. The project began in September 2007 and
NAS is scheduled to submit a report in December 2008.
    In addition, EPA has developed five individual phthalate human
health risk assessments (DEP, DMP, di(2-ethylhexyl)phthalate, dibutyl
phthalate, and butyl benzyl phthalate) that are currently available on
the Integrated Risk Information System (IRIS) database. The IRIS
Summaries for these phthalates can be found at http://cfpub.epa.gov/ncea/iris/index.cfm?fuseaction=iris.showSubstanceList.
 The IRIS Program

has also undertaken reassessments for di(2-ethylhexyl)phthalate,
dibutyl phthalate, and butyl benzyl phthalate. The schedules for the
reassessments of these phthalates are available on IRIS Track http://cfpub.epa.gov/ncea/iristrac/index.cfm
).

    In sum, the NRDC report indicates that some phthalate esters are
present in some air fresheners at generally low concentrations. This
information is not surprising and does not provide a basis to suspect
that the presence of the phthalate esters at the concentrations
detected presents a significant public health risk. In addition, the
NAS evaluation, which is expected to address phthalate esters more
comprehensively, rather than in a very specific use such as air
fresheners, will help inform any risk assessment or testing needs.
    3. BEUC and SCHER reports. The petition also relies on an opinion
issued by SCHER in January 2006 about a report issued by the Bureau
Europ[eacute]en des Unions de Consommateurs (BEUC) in January 2005 that
measured and assessed chemical emissions from 74 air fresheners sold in
Europe (Refs. 4 and 5).
    In order to understand these reports, some background information
is necessary. BEUC is a European association of national consumer
organizations. In November 2004, BEUC announced that a study it had
commissioned had found that air fresheners emitted toxic air pollutants
(Ref. 17). According to the report, the study tested 74 ``products
belonging to different categories (incense, natural products, scented
candles, aerosols, liquid diffusers, electric diffusers and gels),''
``simulate[ed] common use of such products by consumers,'' and
measured, ``for each product, the concentration of Volatile Organic
Compounds (VOCs) and aldehydes in the air after the use'' (Ref. 5). The
BEUC report focused on emissions of ``total VOCs'' and several
individual VOCs: Allergens, benzene, formaldehyde, terpenes, styrene,
DEP, and toluene. The BEUC report found that the 74 products studied
emitted over 350 different chemicals.
    A company that produces air fresheners filed a lawsuit in Belgium
to compel BEUC to withdraw public statements indicating ``that normal
usage of the fragrances generates serious health risks, and that these
fragrances are not subjected to regulations in terms of product safety
standards'' (Ref. 28). In March 2005, the court found that the BEUC
study did not support statements that air fresheners were ``dangerous
to people's health.'' The court ordered BEUC to withdraw statements
that ``might or could create the impression that fragrances are unsafe
with normal usage'' and issue a statement that its ``repeated public
communications on the subject of air freshener safety'' were ``not
appropriate as the currently known results from [the BEUC study] on
which [BEUC] based [its] statements in effect do not justify the
conclusion that air

fresheners are diffusing substances ... in concentrations that present
a hazard to public health'' and ``may unjustly have generated the
unwarranted impression that the air fresheners on sale in the
Netherlands can result in health risk under normal usage.''
    SCHER was subsequently asked to consider whether the specific
chemical emissions from air fresheners reported in the BEUC study
represented a health risk to consumers and what further studies might
be necessary to adequately assess the potential health risks from air
fresheners. SCHER issued its assessment in January 2006 (Ref. 4). SCHER
noted that ``Neither the composition of the tested products, nor the
rationale for the selection of the individual substances studied are
given in the BEUC report;'' that ``[t]he individual compounds in the
reported results are, in most cases, well studied;'' and that ``[t]he
results in the BEUC study may ... be regarded as realistic worst case
values.'' SCHER noted that, with the exception of benzene emissions
resulting from the burning of certain incense products, the air
concentrations of the substances assessed in the BEUC report were below
known limit values for adverse health effects and/or were within the
range of typical indoor air concentrations.
    SCHER reached the general conclusion that current scientific
knowledge on ``the use of air fresheners, emissions and resulting
concentrations in indoor air'' was ``limited'' and that ``the
[exposure] data on air fresheners available to the SCHER are
insufficient for an overall risk evaluation for consumers.'' SCHER
concluded that ``[m]ore data, on e.g. the use pattern of these
products, are required to allow assessment of the actual exposure of
the residents'' and that, in particular, ``the frequency of the used
air freshener, the duration of exposure and the frequency of peak
levels needs to be considered.''
    EPA conducted a literature review of sources of information
relevant to human exposure to air freshener products (i.e.,
formulation, emission measurement, air monitoring, and modeling
information) (Ref. 21). This review identified additional studies not
reviewed in the BEUC and SCHER reports. Some of the same analytes
reported in the BEUC report (e.g., terpenes and formaldehyde) were
detected in these studies, usually at lower maximum concentrations than
those reflected in the BEUC report.
    EPA then reviewed the BEUC and SCHER reports in light of the
information gathered during the literature review (Ref. 18). EPA
concluded, as did the SCHER report, that there were deficiencies
related to the quality of the data in the BEUC report. EPA concluded
that the information and findings in the BEUC report did not appear to
satisfy EPA's Information Quality Guidelines (Ref. 19). EPA also
concluded that uncertainty about how representative the BEUC results
are for the U.S. air freshener market is a key limitation in their
usefulness for estimating potential U.S. consumer exposures.
    The petitioners point out that BEUC found that ``for most products
tested the emitted total VOC values exceeded 200 microgram/milligram
cubed ([micro]g/m\3\), the proposed maximum limit value in indoor air
in several countries...'' While total VOC does measure the presence of
VOCs indoors, there is no validated evidence to indicate that this
measure is a predictor of indoor air quality concerns or potential
health effects. Total VOC does not indicate the impact of other
pollutants present or building factors that may also impact indoor air
quality and health. In addition, there is no standardized procedure for
measuring total VOCs and, therefore, no ability to compare between
reported measurements. Although under certain conditions total VOC
measurements may be useful as a screening tool, EPA does not believe
total VOC measurements should be used as an indicator of indoor air
quality or health concerns.
    4. Epidemiological studies and other information. In addition to
the three sources listed in Unit II.D., the petitioners submitted to
EPA epidemiological studies as additional support (Refs. 22 and 23).
Reference 23 was submitted as part of the petition. Reference 22 was
submitted after the petition and, consequently, is not considered by
EPA to be part of the petition. However, EPA reviewed both studies. The
studies attempted to determine whether there was an association between
asthma and either the use of common household cleaners or chemical
hypersensitivity. EPA's review concluded that both studies, neither of
which was specifically designed to evaluate possible health effects
related to exposure to air fresheners, contained numerous design
limitations and could not be used to support an association between
asthma and the use of air fresheners (Ref. 20).
    Petitioners also present certain arguments about the risks and
benefits of air fresheners. Petitioners assert that ``air fresheners
provide no public health value'' (Ref. 1). Petitioners further assert
that air fresheners may mask the presence of mold and other health
threats (Ref 1). Petitioners have provided no basis for EPA to evaluate
these assertions, although EPA agrees that, in general, air fresheners
are not a solution for indoor air quality issues. In addition, public
health value is not the only type of benefit cognizable under TSCA. As
petitioners recognize, air fresheners are purchased in large
quantities, and, as noted in comments submitted by industry, 70% of
homes in the United States use air fresheners (Ref. 7); which together
suggest that consumers place significant value on them. With regard to
petitioners' second assertion, EPA sees no connection between the
actions requested and any risk that might be presented by the masking
of mold or similar conditions.
    5. Conclusion. The information provided by petitioners does not
support the conclusion that air fresheners present a significant health
risk, or a health risk that is a priority in relation to risks
potentially posed by other chemicals or products. In addition to the
limitations discussed in Unit II.D., it is clear that the information
supplied by petitioners is only a sample of the information available
on health risks potentially associated with air fresheners. Based on
comments received during the comment period and independent inquiry by
EPA (see Unit III.C.1.), there are a number of additional publicly
available studies and analyses of the potential health effects from air
fresheners and air freshener ingredients. Industry commenters assert
that some of these studies demonstrate that air fresheners in general
do not present a significant risk (Refs. 24 and 25). EPA expresses no
view on this industry characterization, but EPA cannot judge whether
air fresheners generally, or any particular air fresheners, present an
unreasonable risk, or a significant risk at all, without further review
of available information.

E. Other Considerations

    EPA has a number of high priority chemical assessment and risk
management projects and actions already underway that are requiring a
substantial amount of OPPT resources. EPA views many of these projects
as being more broadly applicable, and as having greater potential to
result in the understanding and reduction of possible chemical risks,
than the actions suggested by the petitioners. These projects include,
for example, the following:
    In August 2007, the President committed the United States to join
Canada and Mexico in a collaborative effort under the Security and
Prosperity Partnership (SPP) to rapidly and efficiently improve
chemical security

and safety throughout North America. The U.S. contribution to this
partnership is, by 2012, to assess and initiate needed actions on the
approximately 9,000 chemicals manufactured in, or imported into, the
United States in volumes greater than 25,000 pounds. These include
3,000 ``high-production-volume'' (HPV) chemicals (produced or imported
at 1 million lbs/year annually) and 6,000 ``medium-production-volume''
MPV chemicals (produced or imported between 25,000 and 1 million lbs/
year). EPA expects that many of the ingredients of air fresheners will
be encompassed within these groups of chemicals. The North American
collaboration also provides for the sharing of scientific information
and technical understanding, best practices, and research on new
approaches to chemical testing and assessment. The scope and pace of
this commitment represents a significant commitment of Agency resources
over the period of the next 5 years. Additional information on this
commitment can be found at: http://www.epa.gov/chemrtk/index.htm.

    Another, chemical-specific, project involves conducting and
integrating new studies into the ongoing risk assessment on
perfluorooctanoic acid (PFOA) and managing the related 2010/15 PFOA
Stewardship Program, in which companies have committed to reduce
emissions and product content of PFOA and other perfluorinated
compounds, many of which have been found in the blood of the general
U.S. population. Additional information on this project can be found
at: http://www.epa.gov/oppt/pfoa/index.htm.

    In addition, EPA has several efforts underway under the Design for
the Environment (DfE) Program. DfE works in partnership with a broad
range of stakeholders to reduce risk to people and the environment by
preventing pollution. One example of special relevance to fragrances
and air fresheners is DfE's work with formulators of chemical products
to identify safer chemical alternatives for ingredients of concern and
to recognize those formulators who develop safer chemical products
through green chemistry. Cleaning products can contain a wide variety
of ingredients including surfactants, solvents, builders, and
fragrances. Fragrances are key ingredients in some cleaning products.
To enable and further environmental stewardship in the fragrance
industry, and to help fragrance houses identify safer ingredients for
the formulation of fragrances in cleaning products, DfE is working with
stakeholders from the fragrance industry, formulators of cleaning
products, environmental groups, and other Agency representatives. The
goal of this stakeholder effort is to define safer fragrance materials
for cleaning products, and provide fragrance houses and cleaning
product formulators with a marketplace for those ingredients.
Additional information on the DfE program in general and the
formulators project in particular is available at: http://www.cleangredients.org
.

III. Disposition of Petition

    EPA has concluded that the petition does not set forth sufficient
facts to support the petitioners' assertion that it is necessary to
initiate the requested rulemakings under TSCA sections 4, 6, or 8(d).
Furthermore, EPA has concluded that a TSCA section 8(c) data call-in is
not a petitionable matter under TSCA section 21. A detailed explanation
of EPA's determination follows.

A. TSCA Section 8(c) Request

    The petitioners requested that EPA ``call-in allegations of adverse
reactions recorded by manufacturers and processors [of air fresheners]
pursuant to TSCA section 8(c) and 40 CFR part 717 [EPA's TSCA section
8(c) regulations].''
    Section 8(c) of TSCA provides that ``[a]ny person who manufactures,
processes, or distributes in commerce any chemical substance or mixture
shall maintain records of significant adverse reactions to health or
the environment, as determined by the Administrator [of EPA] by rule,
alleged to have been caused by the substance or mixture,'' and that,
``[u]pon request of any duly designated representative of the
Administrator, each person who is required to maintain records under
[TSCA section 8(c)] shall permit the inspection of such records and
shall submit copies of such records.'' 15 U.S.C. 2607(c). EPA issued
regulations implementing TSCA section 8(c), 40 CFR part 717, which were
published in the Federal Register issue of August 22, 1983 (48 FR
38187). These regulations provide that EPA may require that records of
allegations of significant adverse reactions be reported either by
letter or by notice in the Federal Register: ``EPA will notify those
responsible for reporting by letter or will announce any such
requirements for submitting copies of records by a notice in the
Federal Register.'' 40 CFR 717.17(b).
    The requested call-in is not a petitionable matter under TSCA
section 21. Among the actions potentially available under TSCA section
8, only rules are proper objects of a TSCA section 21 petition.
Pursuant to TSCA section 8(c), and EPA's implementing regulations at 40
CFR 717.17, allegations of adverse reactions are not called in by rule.
In contrast, other provisions of TSCA--including part of TSCA section
8(c)--require or authorize the Administrator to act by rule. Section 21
of TSCA allows any person to petition ``to initiate a proceeding for
the issuance, amendment, or repeal of a rule under section 2603, 2605,
or 2607.'' 15 U.S.C. 2620(a). EPA interprets TSCA section 21 to apply
only to the enumerated actions. EPA believes the Congress reasonably
chose to extend TSCA section 21 only to the specific rules and orders
identified under TSCA section 21. In general, rules are more broadly
applicable and more significant regulatory actions than individual
implementation actions, such as TSCA section 8(c) call-ins. While TSCA
section 21 provides for petitions for 2 types of orders, these rest on
findings related to potential health or environmental risks, or
production and release of, or exposure to, a chemical or mixture, and
each requires potentially significant action by the recipient of the
order. Congress chose not to extend TSCA section 21 to other kinds of
agency implementation actions.

B. Denial of TSCA Section 8(d) Request

    Petitioners requested that EPA promulgate a rule pursuant to TSCA
section 8(d) to require submittal of heath and safety studies related
to air fresheners, including lab results of ingredients and health
effects from respiratory exposures. This request is denied. Petitioners
have not set forth sufficient facts to establish that it is necessary
to initiate the requested TSCA section 8(d) rulemaking.
    First, in order to grant petitioners' request, air fresheners would
have to be treated as a category of mixtures, rather than an individual
chemical or particular mixture, and based on the limited analyses
undertaken in responding to the petition, EPA does not believe that it
would be appropriate at this time to treat the vast array of air
freshener products as a category. The issues associated with addressing
air fresheners as a category are further discussed in Unit III.C.1.
Second, petitioners have not provided sufficient facts or information
to support their assertion that air fresheners present an unreasonable,
or even a significant, risk. Finally, even if petitioners had
demonstrated that air fresheners present an unreasonable risk, they
have not demonstrated that the requested TSCA section 8(d) rule would
be necessary or

an appropriate tool to protect human health against that risk.
    As described in Unit II.D., the information that the petitioners
relied upon to support their request is not persuasive and is not
adequate to support the assertion that air fresheners present a
significant public health risk, much less an unreasonable risk.
    The cost of this TSCA section 8(d) rule would be substantial for
both the industry and the Agency. Although such a rule would not
require industry to perform new testing, the scope of studies covered
by the requested rule would be very broad. It is not clear whether the
``manufacturers and processors'' that would to be subject to the rule
petitioners request are intended to include manufacturers and
processors of air freshener ingredients as well as products. Such a
rule would potentially cover a very large group of entities, products,
and ingredients.
    In addition, this rulemaking would require substantial Agency
resources to develop, and significant Agency resources would also be
required to analyze submitted studies on air fresheners.
    Petitioners request EPA to use a TSCA section 8(d) rule to obtain
ingredient information. While information on air freshener ingredients
could be a useful starting point for assessing whether air fresheners
present any significant health risk, TSCA section 8(d) does not provide
an efficient or effective way to obtain ingredient information because
a TSCA section 8(d) rule would only obtain the ingredient information
that was part of a health or safety study. Section 8(d) of TSCA is not
designed for, and is not an efficient or effective means of obtaining
general or comprehensive ingredient information on air fresheners.
    As a second general type of information, petitioners request EPA to
use a TSCA section 8(d) rule to obtain information on ``exposure of
consumers to air fresheners,'' ``health effects of exposure to air
fresheners,'' and ``toxicity, persistence, and other characteristics of
air fresheners that affect health and/or the environment.'' EPA
generally considers this type of information to be health and safety
information, which could be obtained through a TSCA section 8(d) rule.
However, air fresheners are mixtures of chemicals, not individual
chemicals, and as such contain a large number and wide variety of
different chemicals. As a result, the interpretation of individual air
freshener study results could be very difficult. When assessing studies
of mixtures it is frequently difficult to determine which chemical or
combination of chemicals produced a given result or caused a given
effect. Further, the likely compositional diversity of the tested air
freshener formulations presents EPA with difficulties in assessing the
significance of any such health and safety studies in relationship to
the ingredients and concentrations that are commonly present in
commercially available air fresheners. Moreover, since air freshener
ingredients are likely to change over time, the value or significance
of health and safety study information on particular air freshener
formulations could be limited.
    EPA would want a better general understanding of air freshener
ingredients before concluding that the broad rule requested by the
petitioners is a necessary or efficient tool to address possible health
effects associated with air fresheners. In addition, EPA currently does
not view collection of TSCA section 8(d) information on air fresheners,
or analysis of such information should EPA obtain it, as a high
priority among the many chemical issues and activities that the Agency
could potentially expend resources investigating, and the petitioners
have not persuaded EPA otherwise.
    Accordingly, EPA concludes that the petitioners have not set forth
sufficient facts to support their assertion (and information available
to EPA does not otherwise indicate) that it is necessary or appropriate
to issue the requested TSCA section 8(d) rule.

C. Denial of TSCA Section 4 Request

    Petitioners requested that EPA promulgate a rule under TSCA section
4 to require ``acute and chronic studies that use appropriate exposure
routes and that capture a diversity of life stages and health
conditions, such as asthma, for large populations of mammals evaluating
the impact of air fresheners on human health. These tests must consider
the byproducts of a reaction of the air fresheners with ozone and
analyze both exposure and sensitization'' (Ref. 1). This request is
denied. Petitioners have not set forth sufficient facts to support
their assertion that it is necessary to issue a TSCA section 4 rule, as
required by TSCA section 21(b)(1).
    In addition to the request for a TSCA section 4 testing rule with
respect to ``air fresheners'' as described in the petition, petitioners
also presented additional requests, orally and in written comments. EPA
does not consider these additional requests part of the TSCA section 21
petition, but nonetheless does address the petitioners' suggested
alternative approaches in this unit.
    1. TSCA section 4 request set forth in petition. Petitioners have
not set forth sufficient facts to support their assertion that it is
necessary to issue a TSCA section 4 rule for air fresheners.
    As a threshold matter, petitioners' request as articulated in the
petition would entail treatment of ``air fresheners'' as a category of
chemical substances or mixtures (almost certainly mixtures, since it is
unlikely that any air freshener is composed of a single chemical
substance). Petitioners present both their request and their support
for the request in terms of ``air fresheners.'' For example, the
petition states, ``air fresheners may pose a risk to public health''
and defines air fresheners broadly to include a ``broad range of
product types,'' from sprays to ``plug-ins'' to potpourri. Thus,
treatment of air fresheners as a category would be necessary to grant
petitioners' request as articulated in the petition.
    EPA has broad discretion to determine whether to regulate by
category under TSCA section 26(c). Beyond the language of TSCA section
26(c), this discretion is evidenced by the fact that TSCA section
21(b)(4)(B)(i) provides an opportunity for a de novo hearing with
respect to petitions for testing of chemical substances, but not for
categories of chemicals or mixtures. As with mixtures, Congress left
the complex issues associated with regulation by category to the
Administrator's discretion. Congress intended this authority to
``facilitate the efficient and effective administration'' of TSCA.
Senate Report No. 94-698 at p. 31.
    While a broad category might be appropriate under certain
circumstances, based on the limited analyses undertaken by EPA in
responding to the petition, EPA does not believe that treating air
fresheners as a category for the purposes of a TSCA section 4 testing
rule would be appropriate, efficient, or effective at this time given
the large number and wide variety of air fresheners. There is a vast
array of mixtures and physical forms within the meaning of air
fresheners that the petitioners provide. The category is so broad and
varied that similar treatment for each member of the category (i.e.,
testing of each member) would not be practical, efficient or effective.
In addition, EPA is not able at this time, nor would it be able in the
reasonably foreseeable future, to identify a standard or standards for
development of certain test data, as required by TSCA section 4(b)(1),
that would be appropriate to the category as a whole. Specifically, EPA
is currently not aware of any standard test

method for testing respiratory sensitization in animals. Given limited
information and the lack of applicable standards, a testing rule for
the category air fresheners would take years and a very large
expenditure of resources for EPA to develop, promulgate and implement.
In addition, a requirement to conduct the wide array of testing
requested by petitioners would be costly for industry. The
implementation of such a requirement would entail multiple methods to
test a wide variety of products for each of the identified endpoints.
Moreover, even if EPA could identify or devise appropriate test
standards for respiratory sensitization, it is not at all certain that
testing of air fresheners for this effect or other acute and chronic
effects would provide useful data relevant to determining whether air
fresheners as a class, or any particular chemical substances or
mixtures, present an unreasonable risk. As described in Unit III.B.,
the interpretation of air freshener study results would be problematic.
    Even if category treatment were appropriate, petitioners have not
set forth sufficient facts and information to support the TSCA section
4 findings for air fresheners.
    First, petitioners have not set forth facts sufficient to support
the required finding for mixtures under TSCA section 4(a)(2): That the
effects of air fresheners would not be ``reasonably and more
efficiently determined or predicted by testing the chemical substances
which comprise the mixture.'' 15 U.S.C. 2603(a)(2). EPA has broad
discretion to make this finding, and EPA does not, at this time,
believe this finding is warranted. (TSCA section 21(b)(4)(B)(i)
provides an opportunity for a de novo hearing with respect to petitions
for testing of individual chemical substances, but not for mixtures.)
On the contrary, based on the limited analyses undertaken by EPA in
responding to the petition, identifying individual substances used in
air fresheners and proceeding with additional requirements only where
appropriate with respect to particular substances would be the more
reasonable and efficient approach and would allow the Agency to target
both public and private resources towards developing useful data. Given
more complete information on the chemical substances, EPA might
conclude that testing of some air freshener mixtures or ingredients
would be appropriate, but petitioners provide no basis to support this
finding for the category of air fresheners as a whole.
    Petitioners assert that the testing of individual chemical
substances alone could lead to gaps in data about synergistic effects
or byproducts of air fresheners with ozone. While this is possible,
petitioners have not provided any information to support the assertion
nor at present does EPA have any basis to evaluate the assertion.
    In addition, petitioners have not set forth sufficient facts to
support the other required TSCA section 4 findings as described in Unit
II.B.2. For example, petitioners have not set forth sufficient facts
for EPA to find that information available to the Administrator is
insufficient to permit a reasoned evaluation of the health and
environmental effects of air fresheners, or that testing of the air
fresheners is necessary to develop missing data. 15 U.S.C. 2603.
Petitioners have cited some information in an attempt to make these
showings. For example, they point out that the EPA HPV Information
System contains no repeat dose toxicity studies for respiratory
exposure for the common fragrances reported in the BEUC study, and that
more than 25 material safety data sheets (MSDSs) on air fresheners
reviewed by the petitioners indicated no data are available for
respiratory tract sensitization. This information could be suggestive
of an insufficiency of data, but EPA cannot judge whether existing data
or experience are insufficient to determine or predict the health
effects of air fresheners and, even so, whether new testing would be
necessary to develop such data without review of the additional
available information. EPA's literature search indicates the existence
of many published health and safety studies pertaining to the potential
health effects of air fresheners or their ingredients (Ref. 24).
Further, comments received on the petition indicate a large body of
information created and maintained by the fragrance industry of which
many are reported to be published in peer-reviewed scientific
literature (Ref. 25).
    In light of the large body of additional available information
which was not considered by petitioners, the petition does not support
petitioners' claims regarding the insufficiency of existing data or
that testing is necessary.
    For these reasons, the petitioners have not demonstrated that it is
necessary or appropriate to issue the requested TSCA section 4 rule.
    2. Additional TSCA section 4 request articulated at meeting. EPA
met with petitioners at their request on October 24, 2007, to discuss
this petition. At that time, petitioners indicated that they intended
their TSCA section 4 request to be for the testing of individual
chemical substances used in air fresheners, not the air fresheners
themselves (Ref. 26). A request to promulgate a TSCA section 4 rule
with respect to either a category of chemical substances or individual
chemical substances is significantly different from the request as
articulated in the petition. Given the petitioners' obligation to
articulate requests and set forth facts in their petition, EPA does not
view this request as part of the petition. Nonetheless, EPA will
address the alternative approaches identified by petitioners.
    First, EPA does not believe the designation of ``chemical
substances used in air fresheners'' as a category of chemical
substances for the purpose of the requested TSCA section 4 testing rule
is appropriate, for reasons similar to those discussed in Unit III.C.1.
This category is extremely large, undefined and indiscriminate. It
appears that petitioners are requesting that EPA require testing for
all of the chemical substances in all air fresheners (Ref. 27, p. 1).
This would be a massive testing rule--significantly larger than any EPA
has ever promulgated before. In addition to the sheer scope of the
requested rule, similar treatment for each member of the category would
not be practical, efficient or effective. The chemical substances in
air fresheners have not been completely identified, and EPA has no
reason to believe that by virtue of their use in air fresheners, these
substances would be appropriate for treatment as a category for the
purposes of a TSCA section 4 rule. In addition, petitioners have failed
to set forth facts sufficient to support the TSCA section 4 findings as
described in Unit II.B.3. with respect to the category of ``chemical
substances used in air fresheners.'' The petitioners have not shown
that the TSCA section 4 findings can be made for any chemical substance
used in air fresheners. In addition, the category is likely to include
chemicals that are benign, and/or are not produced in substantial
quantities, and/or that have been extensively studied. Therefore, EPA
does not believe that the requested testing of all chemical substances
used in air fresheners should be applied.
    To the extent petitioners seek testing on only some of the chemical
substances used in air fresheners, petitioners have not specified for
which ingredients testing should be required nor have they provided
information that would enable EPA to make the TSCA section 4 findings
with respect to any individual chemical substances. Petitioners have
identified a few chemical substances used in air fresheners, but they
have not set forth facts with respect to any individual

substances to support the TSCA section 4 findings. For example,
petitioners identify phthalate esters as a category of chemicals they
are concerned about, but they have not shown that phthalate esters as a
category, or any particular phthalate ester, meet the findings under
TSCA section 4(a)(1). In addition, with respect to phthalate esters,
the NAS evaluation regarding phthalate esters will help inform
consideration of the sufficiency of the existing data and the need for
any testing.
    3. Additional TSCA section 4 request made in comments. Through
written comments on the petition dated November 5, 2007, petitioners
presented an additional request for a rule requiring that ``[each of
the] manufacturers [of air fresheners] specifically test at least one
formulation for each category of air freshener that it sells'' (Ref.
27). EPA again considers this additional request to be different from
the request in the petition, and not part of the petition, but will
address the alternative approach identified by petitioners.
    In order to require testing under TSCA section 4 on a particular
mixture, the TSCA section 4 findings must be met with respect to the
mixture to be tested. Petitioners' request is essentially for a rule
requiring testing on individual mixtures, which they have identified as
``formulations.'' While petitioners' comments imply that any
``formulation'' might be a candidate for testing, they do not identify
any particular mixture, nor have they provided a rationale for
selecting which air fresheners should be tested.
    The petitioners have not set forth facts sufficient to support
their assertion that a TSCA section 4 testing rule is necessary with
respect to any particular mixture. It is possible that some air
freshener ``formulations'' may meet the standards for testing as
described in Unit II.B.2., but the petitioners have not identified such
a mixture or provided any information toward these findings. For
example, the petitioners have not set forth sufficient facts to make
the necessary finding under TSCA section 4(a)(2) with respect to any
mixture. As described in Unit II.B.3., EPA would have to find that the
effects of the mixture ``may not be reasonably and more efficiently
determined or predicted by testing the chemical substances which
comprise the mixture.'' 15 U.S.C. 2603(a)(2). Here, as described in
Unit III.C.1., EPA currently believes that identifying individual
substances used in air fresheners and proceeding with additional
requirements only where appropriate with respect to particular
substances, would be the more reasonable and efficient approach. By way
of further example, petitioners have also not set forth sufficient
facts to show an insufficiency of data or necessity of testing for any
particular formulations. Rather, ``air fresheners'' by the petitioners'
own definition encompass a ``broad range of product types'' and varying
formulations.
    To the extent the petitioners assert that testing of some subset of
air fresheners could be required as a category of mixtures, this
approach presents the same problems identified in Unit III.C.1. While
the category described in the petitioners' comment is not quite as
sweeping as the request in their petition, it is still a very expansive
and ill-defined category of mixtures, and more information and analysis
would be needed to determine if such an approach even merits further
consideration.

D. Denial of Request to Issue TSCA Section 6 Labeling Rule

    The petitioners requested that EPA issue a rule under TSCA section
6(a)(3) requiring air fresheners to be labeled to identify all
ingredients. This request is denied. Petitioners have not set forth
sufficient facts to establish that it is necessary to initiate the
requested TSCA section 6(a) rulemaking.
    In support of their request, the petitioners assert that
manufacturers and importers are already aware of the ingredients in
their products, that their products are unnecessary, and that requiring
the requested labeling would therefore impose an insignificant cost.
The petitioners also assert that many of the chemicals present in air
fresheners are toxic. However the petition does not provide a
reasonable basis to conclude that air fresheners, or the chemicals used
in air fresheners, present or will present an unreasonable risk of
injury to health or the environment. In addition to the limitations of
the three reports petitioners principally rely on, the petition does
not provide a basis upon which to estimate the cost of the requested
rulemaking. Furthermore, the petition does not provide a basis for
finding that the action requested by petitioners would be necessary to
protect adequately against any unreasonable risk, or that it is the
least burdensome requirement that would adequately protect against such
risk.
    As a threshold issue, as with their other requests, the petitioners
do not demonstrate that any particular air freshener or air freshener
ingredient presents or will present an unreasonable risk. The
petitioners do briefly discuss some specific risk issues, but their
statements are not sufficient to support any risk conclusions about any
particular products or ingredients. For example, they cite the
conclusions of the SCHER report that burning of some incense products
available in Europe generated high benzene concentrations and that such
``benzene emissions need attention to diminish the exposure'' (Ref. 4).
EPA does not believe this information is relevant, because the
definition of air freshener provided by the petitioners does not appear
to include incense. The definition in the petition does not include any
products involving combustion--a process that raises issues
significantly different from those raised by non-combustion products.
In addition, combustion--whether of incense, candles, or anything
else--creates chemicals that are not present in the original article,
and it does not appear to EPA that the listing of ingredients in the
article would be an effective means of protecting against any risk that
might result from combustion of the ingredients.
    Because the petitioners have not set forth sufficient facts with
respect to any particular air freshener mixture or ingredient, EPA
would have to treat air fresheners as a category of mixtures in order
to grant the petitioners' request under TSCA section 6(a). This would
result in a rule requiring labeling for a very broad product type,
despite the fact that the petitioners have not shown that any specific
air freshener, or air fresheners generally, present or will present an
unreasonable risk. As described in Unit II.D., the information that the
petitioners relied upon to support their request do not provide
sufficient facts to support the assertion that air fresheners present
or will present a significant risk, much less an unreasonable risk to
human health or the environment. In addition, while not part of the
petition, EPA also considered information provided by the petitioners
and others during the public comment period. This information also did
not provide a reasonable basis to conclude that air fresheners, or the
chemicals in air fresheners, present or will present an unreasonable
risk of injury to health or the environment.
    In addition to the limitations of the risk information provided by
petitioners, petitioners did not provide adequate information to
address the other components of the unreasonable risk standard. These
relate not merely to the effects of the mixture (i.e., air freshener),
or the chemicals comprising the mixture, but also to the benefits of
the substance(s) for various uses and the availability of substitutes
for such uses and to the reasonably ascertainable economic consequences
of the control

mechanisms proposed to control the risk.
    These considerations are integral to the determination that there
is a reasonable basis to conclude that a substance presents or will
present an unreasonable risk, and the petitioners have not presented
sufficient facts to address them. The petitioners asserted that the
costs of their requested controls would be small and that the benefits
of their controls would reduce risk, but provided no data or other
information to substantiate either their estimates of cost or of the
efficacy of their proposed control action. With respect to cost,
contrary to petitioners' assertion, it seems likely to EPA that the
cost of a rule requiring the listing of every ingredient of every air
freshener would be substantial. The cost to the Agency of promulgating
such a rule would also be very large. EPA would need to develop
sufficient information to provide a reasonable basis to conclude that
air fresheners as a category present or will present an unreasonable
risk (it would need a record significantly more extensive than the
information supplied by petitioner), and that product labeling is the
least burdensome requirement that would adequately address that risk.
The petitioners made no attempt to address this last requirement.
    With regard to the benefits of air fresheners, even assuming air
fresheners provide no public health value, this is not the only kind of
benefit cognizable under TSCA. As petitioners recognize, air fresheners
are purchased in large quantities, which suggests that consumers place
significant value on them.
    In sum, the petitioners have not set forth sufficient facts to
establish that the requested rulemaking under TSCA section 6 is
necessary, and EPA has denied the request.

IV. Comments Received

    EPA published a notice in the Federal Register issue October 23,
2007 (72 FR 60016) (FRL-8154-5) announcing receipt of the petition and
inviting public comment on or before November 7, 2007. EPA received 28
timely comments, 4 of which were from the petitioners. One of the
comments was received the day after the comment deadline due to a
delivery problem on the part of the courier. EPA decided to consider
this comment with the others.
    Eleven comments were from individuals who supported the petition.
Several were allergy or asthma sufferers who felt that air fresheners
aggravate their health problems. Several indicated a belief that
manufacturers are not adequately testing their products and were
especially concerned about children and air freshener misuse.
    Five comments were from health, environmental, or animal welfare
non-profit organizations (Toxics Information Project, Environmental
Health Coalition of Western Massachusetts, People for the Ethical
Treatment of Animals (PETA), Ecological Health Organization (ECHO), and
the American Lung Association of New England). Four of the five
supported the petition, while the fifth, PETA, supported portions of
the petition in principle, while opposing the portion calling for
testing on large numbers of animals. PETA criticized some of the
information that the petitioners cited in support of their petition,
and argued that additional animal testing is not necessary and would
not provide useful information on the effects of air fresheners on
human health.
    Eight comments were received from air freshener manufacturing
companies named in the petition and from trade organizations
representing manufacturers of fragrance and fragrance-related products.
(Reckitt Benckiser, Soap and Detergent Association, Grocery
Manufacturers/Food Products Association, Fragrance Materials
Association of the United States, Consumer Specialty Products
Association, Dial Corporation, American Chemistry Council Phthalate
Esters Panel, and Blythe, Inc.). All of these companies and
organizations opposed EPA granting any part of the petition. The
American Chemistry Council Phthalate Esters Panel and the Fragrance
Materials Association of the United States (FMA) comments focused on
the safety of several phthalate esters and the remainder of the
commenters focused on air fresheners and fragrances generally.
    The Consumer Specialty Products Association (CSPA) comments are
representative of the industry comments, and almost all of the other
industry commenters specifically endorsed CSPA's comment submission.
The CSPA comment argued that the petition should be denied because:
    1. There is inadequate evidence that air fresheners cause
significant adverse reactions.
    2. Sufficient air freshener safety data are already available to
EPA.
    3. The fragrance industry is already engaged in safety testing.
    4. Labeling requirements are unjustified and duplicative of FHSA.
CSPA's comments asserted that the fragrance industry is adequately
self-regulating through an industry research and testing organization,
Research Institute for Fragrance Materials, and an industry standards-
setting organization, International Fragrance Association. The comment
included documents explaining the role of these organizations in the
evaluation of ingredient safety by the fragrance industry. CSPA
comments (and those from the two companies) explained the product
stewardship programs used by Reckitt Benckiser and SC Johnson. CSPA's
comments included their disagreements with and criticisms of the
studies and data that petitioners used to support their position, and
supplied additional studies that CSPA argued demonstrate the safety of
fragrances and/or air fresheners.
    The petitioners submitted four more comments, including two
epidemiological studies: One on household cleaning sprays and adult
asthma and one on prenatal phthalate ester exposure. Petitioners also
submitted a press release about a National Institutes of Health (NIH)
study concluding that exposure to 1,4-dichlorobenzene, a VOC, used in
household cleaning products, may cause reductions in lung function.
Finally, petitioners submitted a comment clarifying two terms used in
their petition, and further defining the type and scale of testing they
are petitioning for under TSCA section 4. Given the petitioners'
obligation to clearly articulate requests and set forth facts in their
original petition and the short span of time within which EPA must
respond to the petition as written, EPA does not view the
clarifications and scope modifications subsequently submitted in
petitioner's comments as components of the petition. Nevertheless, EPA
has considered and addressed petitioners' comments, as detailed in Unit
III.

V. References

    1. Sierra Club, Alliance for Healthy Homes, National Center for
Healthy Housing and Natural Resources Defense Council. Letter from Ed
Hopkins, Sierra Club; Robert Zdnek, Alliance for Healthy Homes; Rebecca
Morley, National Center for Healthy Housing; and Mae C Wu, Natural
Resources Defense Council to Stephen Johnson, Administrator,
Environmental Protection Agency and Commissioner Thomas Moore, U.S.
Consumer Product Safety Commission. Re: Citizen Petition to EPA and
CPSC Regarding Air Fresheners. September 19, 2007.
    2. CPSC. Letter from Lowell F. Martin, Acting General Counsel,
Office of the General Counsel, U.S. Consumer Product Safety Commission,
to Mr. Ed Hopkins, Director, Environmental Quality Program, Sierra
Club; Ms. Rebecca Morley, National Center for

Health Housing; Mr. Robert Zdenek, Alliance for Healthy Homes, and Mae
C. Wu, Natural Resources Defense Council. November 23, 2007.
    3. Lai, M.W.; Klein-Schwartz, W.; Rodgers, G. C.; Abrams, J. Y.;
Haber, D. A.; Bronstein, A. C.; and Wruk, K. M. 2006. 2005 Annual
Report of the American Association of Poison Control Centers' National
Poisoning and Exposure Database. Clinical Toxicology. 44:803-932.
    4. European Commission, Scientific Committee on Health and
Environmental Risks (SCHER). Opinion on the Report: ``Emission of
chemicals by air fresheners: Tests on 74 consumer products sold in
Europe'' (BEUC report January 2005). January 27, 2006.
    5. Bureau Europ[eacute]en des Unions de Consommateurs (BEUC). The
European Consumers' Organization. Emission of chemicals by air
fresheners: Tests on 74 consumer products sold in Europe. 54 pp.
January 2005.
    6. Cohen, A. Janssen, S. and Solomon, G. ``Clearing the Air: Hidden
Hazards of Air Fresheners.'' Natural Resources Defense Council.
September 2007.
    7. Reckitt Benckiser, Inc. Letter from Eileen J. Moyer, Director of
Regulatory Relations, to Document Control Office, Office of Pollution
Prevention and Toxics (OPPT), EPA. Docket ID number EPA-HQ-OPPT-2007-
1016-0018.1. November 6, 2007.
    8. EPA. Memorandum from Dirk F. Young, Environmental Engineer,
Exposure Assessment Branch, Economics, Exposure, and Technology
Division, to Robert Jones, Biologist, Chemical Information and Testing
Branch, Chemical Control Division. Subject: Review of 2005 AAPCC on Air
Fresheners. November 18, 2007.
    9. EPA. E-mail communication from Tala Henry, Toxicologist, Risk
Assessment Division, to Andrea Pfahles-Hutchens, Epidemiologist, Risk
Assessment Division with E-mail communication response from Andrea
Pfahles-Hutchens to Tala Henry. Re: Poison control reports. November 5
and 6, 2007.
    10. CDC, HHS. Third National Report on Human Exposure to
Environmental Chemicals. National Center for Environmental Health, NCEH
Pub. No. 05-0570. July 2005. Available on-line at: http://

http://www.jhsph.edu/ephtcenter/Third%20Report.pdf.

    11. State of California. Proposition 65 List of Chemicals.
September 27, 2007. Available on-line at: http://www.oehha.ca.gov/prop65.html
.

    12. SCCNFP. The Scientific Committee on Cosmetic Products and Non-
Food Products Intended for Consumers. Opinion Concerning Diethyl
Phthalate. December 9, 2003.
    13. SCCNFP. The Scientific Committee on Cosmetic Products and Non-
Food Products Intended for Consumers. Opinion Concerning Diethyl
Phthalate. June 4, 2002.
    14. Greenpeace. Perfume: An Investigation of Chemicals in 36 Eaux
de Toilette and Eaux de Parfum. Greenpeace International. 16 pp.
February 2005.
    15. SCCP. Scientific Committee on Consumer Products. Opinion on
Phthalates in Cosmetic Products. March 21, 2007.
    16. NAS. The National Academies. Project Information: Health Risks
of Phthalates. 2007 Available online at: http://www8.nationalacademies.org/cp/projectview.aspx?key=48860
.

    17. Europe Information Service. Product Safety: BEUC Report Claims
Air Fresheners are ``Risk to Health.'' Europe Environment. February 18,
2005.
    18. EPA. Memorandum from Conrad Flessner, Jr., Biologist, Exposure
Assessment Branch, Economics, Exposure, and Technology Division, to
Robert Jones, Biologist, Chemical Information and Testing Branch,
Chemical Control Division. Re: Exposure Information Review of the
Scientific Committee on Health and Environmental Risks (SCHER) Report
on Air Fresheners (December 13, 2007).
    19. A Summary of General Assessment Factors for Evaluating the
Quality of Scientific and Technical Information, U.S. EPA, EPA 100/B-
03/001 (June 2003).
    20. EPA. Memorandum from Andrea Pfahles-Hutchens, Epidemiologist,
Existing Chemicals Assessment Branch, Risk Assessment Division, to
Robert Jones, Project Manager, Chemical Information and Testing Branch,
Chemical Control Division. Subject: Review of Epidemiology Studies for
TSCA Section 21 Petition. November 27, 2007.
    21. EPA. Screening Review of Literature for Air Freshener Exposure
Information. Submitted by Versar Inc., to U.S. Environmental Protection
Agency, Office of Pollution Prevention and Toxics. EPA Contract No. EP-
W-04-035. November 20, 2007.
    22. Zock, J-P; Plana, E; Jarvis, D.;, Anto, J. M.; Kromhout, H.;
Kennedy, S.M.; Kunzli, N.; Villani, S.; Olivieri, M.; Toren, K.; Radon,
K.; Sunyer, J.;, Dahlman-Hoglund, A.; Norback, D., and Dogevinas, M.
2007. The Use of Household Cleaning Sprays and Adult Asthma: An
International Longitudinal Study. American Journal of Respiratory and
Critical Care Medicine. 176: 735-741.
    23. Caress, S. M. and Steinemann, A. C. 2005. National Prevalence
of Asthma and Chemical Hypersensitivity: An Examination of Potential
Overlap. Journal of Occupational and Environmental Medicine. 47:518-
522.
    24. EPA. E-mail communication with sample search results from
Randall Brinkhuis to Greg Schweer. Subject: Search strategy and results
for TSCA section 21 petition on air fresheners. December 3, 2007.
    25. CSPA. Consumer Specialty Products Association. Letter with
enclosure from Robert A. Matthews, McKenna Long and Aldridge, LLP, to
Document Control Office, Office of Pollution Prevention and Toxics
(OPPT), EPA. Docket ID number EPA-HQ-OPPT-2007-1016-0029.1. November 7,
2007.
    26. EPA. Minutes of meeting held October 19, 2007, between EPA and
petitioners. Re: TSCA section 21 petitioners on air fresheners. October
19, 2007.
    27. NRDC. Letter with attachment from Mae C. Wu, Natural Resources
Defense Council and Ed Hopkins, Sierra Club on behalf of petitioners.
Re: Docket ID number EPA-HQ-OPPT-1016, to Document Control Office,
Office of Pollution Prevention and Toxics (OPPT), EPA. Docket ID number
EPA-HQ-OPPT-2007-1016-0013.1. November 5, 2007.
    28. Sara Lee B.V. v. BEUC, KG 05/64 (March 8, 2005).
    29. Cosmetic Ingredients Review (CIR) Expert Panel, 2005. Annual
Review of Cosmetic Ingredient Safety Assessments--2002/2003.
International Journal of Toxicology. 24 (Supp. 1); 1-102.
    30. CEPA. California Environmental Protection Agency, Office of
Environmental Health Hazard Assessment, Reproductive and Cancer Hazard
Assessment Branch. 2007. Proposition 65 Safe Harbor Levels: No
Significant Risk Levels for Carcinogens and Maximum Allowable Dose
Levels for Chemicals Causing Reproductive Toxicity. October 2007.

List of Subjects

    Environmental protection, Air fresheners, Phthalates, Volatile
Organic Compounds (VOCs).

    Dated: December 18, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. 07-6176 Filed 12-19-07; 11:51 am]

BILLING CODE 6560-50-S


[Federal Register: June 16, 2006 (Volume 71, Number 116)]
[Notices]
[Page 34907-34908]
[DOCID:fr16jn06-80]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-369-000]

Straight Creek Gathering, LP; Notice of Petition

June 9, 2006.
    Take notice that on May 30, 2006, Straight Creek Gathering, LP
(Straight Creek), 11251 Northwest Freeway, Suite 400, Houston, Texas
77092, filed in Docket No. CP06-369-000, a petition for a declaratory
order pursuant to Rule 207

of the Commission's Rules and Regulations (18 CFR 385.207) holding that
certain facilities proposed for construction in Floyd, Johnson,
Lawrence, Carter, Magoffin, Elliot, Martin, and Pike Counties, Kentucky
will be gathering facilities exempt from the Commission's jurisdiction
pursuant to section 1(b) of the Natural Gas Act (NGA). Alternatively,
Straight Creek requests that the Commission declare that the facilities
will be non-jurisdictional pursuant to section 1(b) of the NGA, and
issue a limited-term, limited-jurisdictional certificate to permit
Straight Creek to receive gas from Columbia Gas Transmission Company
until Straight Creek can construct its own gathering lateral line into
the supply area, all as more fully set forth in the application which
is on file with the Commission and open for public inspection. This
filing is accessible on-line at http://www.ferc.gov, using the

``library'' link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is a ``subscription'' link on
the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
counsel for Straight Creek, Michael J. Manning or Glenn S. Benson,
Fulbright & Jaworski, L.L.P., at 801 Pennsylvania Avenue, NW.,
Washington, DC 20004; or<PHONE_NUMBER> (Michael Manning) or (202) 662-
4589 (Glenn Benson), or by fax at<PHONE_NUMBER>.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``defiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: June 30, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9387 Filed 6-15-06; 8:45 am]

BILLING CODE 6717-01-P