Discarded Polyvinyl Chloride; TSCA Section 21 Petition; Reasons for Agency Response, 64722-64725 [2014-25849]
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Federal Register / Vol. 79, No. 211 / Friday, October 31, 2014 / Proposed Rules
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Dated: August 22, 2014.
Samuel Coleman,
Acting Regional Administrator Region 6.
[FR Doc. 2014–25725 Filed 10–30–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Chapter I
[EPA–HQ–OPPT–2014–0684; FRL–9918–27]
Discarded Polyvinyl Chloride; TSCA
Section 21 Petition; Reasons for
Agency Response
Environmental Protection
Agency (EPA).
ACTION: Petition; reasons for Agency
response.
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AGENCY:
This document announces the
availability of EPA’s response to a
petition it received under the Toxic
Substances Control Act (TSCA). The
TSCA section 21 petition was received
from the Center for Biological Diversity
(CBD) on July 29, 2014. The petitioner
requested that EPA initiate rulemaking
under TSCA to address risks related to
SUMMARY:
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polyvinyl chloride (PVC), vinyl
chloride, and phthalates used as
plasticizers. The petitioner alternatively
requested that EPA initiate rulemaking
under TSCA to require additional
toxicity testing of these chemical
substances. After careful consideration,
EPA has denied the TSCA section 21
petition for the reasons discussed in this
document. The TSCA section 21
petition was accompanied by an
independent petition for EPA to take
action under the authority of the
Resource Conservation and Recovery
Act (RCRA). EPA continues to review
the petitioner’s requests for action under
RCRA.
DATES: EPA’s response to this TSCA
section 21 petition was signed October
24, 2014..
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Paul
Lewis, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–6738; email address:
lewis.paul@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
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
produce, or who use PVC, vinyl
chloride, or phthalates used as
plasticizers, or substitutes for such
chemical substances. Since many other
entities may also be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action.
B. How can I access information about
this TSCA section 21 petition?
The docket for this TSCA section 21
petition, identified by docket
identification (ID) number EPA–HQ–
OPPT–2014–0684, is available at
https://www.regulations.gov or at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
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Public Reading Room is (202) 566–1744,
and the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
II. TSCA Section 21
A. What is a TSCA section 21 petition?
Under TSCA section 21 (15 U.S.C.
2620), any person can 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. 15 U.S.C. 2620(b)(3). 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. 15 U.S.C. 2620(b)(4).
B. What criteria apply to a decision on
a TSCA section 21 petition?
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 TSCA section 21 petition.
III. TSCA Sections 6 and 4
Of particular relevance to this TSCA
section 21 petition are the legal
standards regarding TSCA section 6
rules and TSCA section 4 rules.
A. TSCA Section 6 Rules
To promulgate a rule under TSCA
section 6, the EPA 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.
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2605(a). This finding cannot be made
considering risk alone. Under TSCA
section 6, a finding of ‘‘unreasonable
risk’’ requires the consideration of costs
and benefits. 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).
In addition, TSCA section 21(b)(4)(B)
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
EPA Administrator to initiate the
requested action. 15 U.S.C.
2620(b)(4)(B). Also relevant to the
issuance of regulations under TSCA
section 6, TSCA section 9(b) directs EPA
to take regulatory action on a chemical
substance or mixture under other
statutes administered by the Agency if
the EPA Administrator determines that
actions under those statutes could
eliminate or reduce to a sufficient extent
a risk posed by the chemical substance
or mixture. If this is the case, the
regulation under TSCA section 6 can be
promulgated only if the EPA determines
that it is in the ‘‘public interest’’ to
protect against that risk under TSCA
rather than the alternative authority. 15
U.S.C. 2608(b).
B. TSCA Section 4 Rules
To promulgate a rule under TSCA
section 4, EPA must make several
findings. In all cases, EPA must find
that data and experience are insufficient
to reasonably determine or predict the
effects of a chemical substance or
mixture on health or the environment
and that testing of the chemical
substance is necessary to develop the
missing data. 15 U.S.C. 2603(a)(1). In
addition, EPA must find either that:
1. The chemical substance or mixture
may present an unreasonable risk of
injury or
2. The chemical substance is
produced in substantial quantities and
may either result in significant or
substantial human exposure or result in
substantial environmental release. 15
U.S.C. 2603(a)(1).
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
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efficiently determined or predicted by
testing the chemical substances which
comprise the mixture.’’ 15 U.S.C.
2603(a)(2).
IV. Summary of the TSCA Section 21
Petition
A. What action was requested?
On July 29, 2014, the CBD submitted
to EPA a ‘‘Petition for Rulemaking
Pursuant to Section 7004(a) of the
Resource Conservation and Recovery
Act, 42 U.S.C. 6974(A), and Section 21
of the Toxic Substances Control Act, 15
U.S.C. 2620, Concerning the Regulation
of Discarded Polyvinyl Chloride and
Associated Chemical Additives’’ (Ref.
1). (The petitioner stated that it was
submitting two ‘‘independent and fully
severable’’ petitions: One under RCRA
and another under TSCA. At this time,
EPA is only responding to the TSCA
section 21 petition. EPA continues to
review the petitioner’s requests for
action under RCRA.)
The TSCA section 21 petition states
that it is requesting issuance of
‘‘regulations governing the safe
treatment, storage and disposal of
polyvinyl chloride (‘‘PVC’’), vinyl
chloride and associated dialkyl- and
alkylarylesters of 1,2benzenedicarboxylic acid, commonly
known as phthalate plasticizers.’’ In its
conclusion, the petitioner urges EPA to
‘‘promptly exercise its authority to
ensure the safe disposal of discarded
PVC.’’
The petitioner requested that EPA
initiate rulemaking under TSCA section
6 ‘‘to reduce the unreasonable risk to
public health and the environment
associated with continued dependence’’
on PVC, vinyl chloride, and phthalates
used as plasticizers. The petitioner also
alternatively requested that EPA take
action under TSCA section 4 ‘‘requiring
manufacturers and processors
responsible for the generation of these
compounds to undertake additional
toxicity testing’’ if ‘‘the Agency
concludes that there are insufficient
data and experience upon which to
determine or predict the effects of
ubiquitous contamination’’ for purposes
of making a TSCA section 6
determination.
EPA interprets the TSCA section 21
petition as requesting EPA to initiate a
proceeding for the issuance of a rule
under TSCA section 6 to address risks
related to the disposal of PVC. The
TSCA section 21 petition is unclear
about whether it is referring to PVC
resins or PVC-based products, but, due
to its emphasis on risks created by
widespread disposal, EPA assumes the
TSCA section 21 petition is about PVC-
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based products (i.e., plastics
manufactured from PVC resin). EPA
therefore interprets the TSCA section 21
petition as arguing that TSCA regulation
of the disposal of PVC-based products is
necessary in order to address certain
post-disposal risks (including risks
relating to chemical substances that the
petitioner believes could be released by
PVC-based products after disposal).
Due to a lack of specificity regarding
the particular action requested, and
other grounds described in Unit V., EPA
denied the TSCA section 21 petition to
initiate rulemaking under TSCA section
6 to address risks from the disposal of
PVC. As a part of its analysis, EPA also
considered whether a broader
interpretation of the TSCA section 21
petition, as furthermore requesting
regulation of the manufacture,
processing, distribution, or use of PVC,
would have altered the Agency’s
decision. EPA considered whether the
facts set forth in the TSCA section 21
petition established that it was
necessary to initiate TSCA section 6
rulemaking to ban or otherwise limit
any specific use of PVC or vinyl
chloride, phthalates as plasticizers, or
metal-based heat stabilizers in
manufacturing PVC as a means of
reducing the quantities of such chemical
substances that enter the disposal
stream in the first place. As described in
Unit V., EPA concluded that, under
such a broader interpretation, EPA
would have denied the TSCA section 21
petition on similar grounds. The TSCA
section 21 petition does not clearly state
a pre-disposal risk management action
that is sought, let alone demonstrate a
risk that is unreasonable.
Finally, EPA notes that it did not
construe the petitioner’s request for
rulemaking under TSCA section 4 as a
strictly contingent request, which EPA
would only consider if it had previously
reached particular factual conclusions
on its own initiative (i.e., ‘‘that there are
insufficient data and experience upon
which to determine or predict the
effects of ubiquitous contamination’’).
Therefore, no inference of implicit
agreement with such conclusions
should be drawn from the fact that EPA
has reviewed whether the TSCA section
21 petition itself sets forth facts
sufficient to justify the initiation of
rulemaking to require toxicity testing
under TSCA section 4.
B. What support does the petitioner
offer?
The petitioner states that PVC, vinyl
chloride, and phthalates used as
plasticizers pose ‘‘significant threats’’ to
human health and the environment.
While the TSCA section 21 petition
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includes information on other chemical
substances related to PVC (e.g., stating
that vinyl chloride is also a concern), it
focuses on the use of phthalates as
plasticizers in PVC. The TSCA section
21 petition states that phthalates are the
most abundant manmade chemicals in
the environment and that ‘‘virtually
universal’’ exposure to phthalates
‘‘could be the leading cause’’ of human
reproductive disorders. The petitioner
expresses concern that ‘‘these
compounds’’ bioaccumulate in living
organisms, interfere with hormone
regulation, and alter sexual
development. The petitioner also
expresses concern that ‘‘human
contamination probably exceeds
previously published estimates’’ and
that harm might be occurring from
‘‘exposure pathways outside the scope
of traditional toxicity testing,’’ such as
‘‘synergistic’’ effects from ‘‘multiple
phthalates’’ or other pollutants. Finally,
citing a single study, the petitioner also
states that ‘‘less harmful alternatives’’ to
these chemical substances are available.
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V. Disposition of TSCA Section 21
Petition
After careful consideration, EPA
denied the petitioner’s request to
initiate a TSCA section 6 rulemaking,
because the TSCA section 21 petition
does not:
• Specify what risk management
action it is requesting,
• Set forth sufficient facts to establish
that the disposal of PVC, vinyl chloride,
or phthalates used as plasticizers
presents or will present an unreasonable
risk, or
• Explain why action under TSCA
would be preferable to action under
other statutory authorities.
EPA also denied the petitioner’s
request to initiate a TSCA section 4
rulemaking to require further toxicity
testing of PVC, vinyl chloride, or
phthalates used as plasticizers, because
the TSCA section 21 petition does not
set forth sufficient facts for EPA to find
that the toxicity information available to
the Agency is insufficient to permit a
reasoned evaluation of the health or
environmental effects of these PVC
constituents, or for EPA to conclude that
toxicity testing is necessary to develop
any missing data.
A. Request for a Rule Under TSCA
Section 6
With respect to its request that EPA
initiate a proceeding for the issuance of
a rule under TSCA section 6 to address
risks related to the manner of disposal
of PVC, the TSCA section 21 petition’s
primary deficiencies are its failure to
specify the risk management action
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sought and its failure to discuss several
major issues intrinsic to an
unreasonable risk determination (i.e.,
risk reduction that would be
accomplished by such action and the
reasonably ascertainable economic and
other social consequences of the action).
Section 21 of TSCA authorizes any
person to petition EPA for the ‘‘issuance
. . . of a rule’’ under TSCA section 6.
As EPA interprets this provision, asking
for a rule entails telling EPA, with
reasonable specificity, what action is
sought in the TSCA section 21 petition.
Simply citing to general legal authority
and stating a desired outcome does not
define an action, and thus fails this
threshold requirement under TSCA
section 21. EPA’s interpretation is
consistent with the short 90-day
deadline for responding to such
rulemaking petitions, as well as with
TSCA’s grant of de novo judicial review
to petitioners. In any such proceeding,
it would be necessary to supply the
court with a specific description of the
relief sought to inform any requested
injunction that EPA ‘‘initiate the action
requested by the petitioner.’’ See 15
U.S.C. 2620(b)(4)(B). Since the court’s
de novo review is itself a rehearing of
the Agency’s prior review of the TSCA
section 21 petition, it follows that the
TSCA section 21 petition itself must
supply the specific description of the
relief sought.
Although the TSCA section 21
petition asserts that ‘‘the inadequate
management of PVC, vinyl chloride, and
phthalate plasticizers poses significant
threats to human and ecosystem
health,’’ the petitioner’s argument as to
the existence of unreasonable risk is
hindered by a nearly complete lack of
detail as to the TSCA risk management
that it is seeking. While the petitioner
stated the overall outcome that it hoped
could be achieved (reduce risk to
human health and the environment
from the disposal of PVC), the petitioner
did not state, in any reasonable manner,
what action available under TSCA
section 6 it sought in order to achieve
that outcome.
The TSCA section 21 petition,
furthermore, failed to set forth sufficient
facts bearing on the relative risk
reduction and the reasonably
ascertainable economic and other social
consequences of the unspecified risk
management action. These issues are
integral to EPA’s assessment of whether
rulemaking under TSCA section 6 is
necessary and, even more
fundamentally, its assessment of
whether a particular risk is in fact an
unreasonable risk. This is because the
finding of unreasonable risk is a
judgement under which the
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decisionmaker determines that the risk
of health or environmental injury from
the chemical substance or mixture
outweighs the burden to society of
potential regulations (Ref. 2). Because
the TSCA section 21 petition omits
discussion of multiple issues that are
intrinsic to the finding of unreasonable
risk, the TSCA section 21 petition fails
to set forth sufficient facts to establish
that the disposal of PVC, vinyl chloride,
or phthalates used as plasticizers
presents or will present an unreasonable
risk.
Finally, while the petitioner
acknowledges that PVC disposal might
also be regulated under other EPA
statutory authorities, such as RCRA, it
has not explained why it believes it
would be preferable to address the risks
of disposal under TSCA, rather than
through other statutory authorities. The
petitioner’s views on this question are
especially difficult to infer given the
absence of information about the
particular TSCA risk management
action sought. This omission is an
impediment to assessing whether a
TSCA section 6 rule would be an
appropriate means of reducing potential
risks related to the disposal of PVC, and
(if so) how such action could be
coordinated, consistent with TSCA
section 9(b), with other actions that EPA
has already taken with respect to these
chemical substances under other
statutes that EPA administers.
For example, the petitioner did not
explain why it believes vinyl chloride
poses an unreasonable risk that should
be addressed under TSCA despite the
impact of multiple rules regulating this
chemical substance under the Clean Air
Act (42 U.S.C. 7400 et seq.), including
one that was recently established in
2012 (Ref. 3). See 40 CFR part 61,
subpart F, and 40 CFR part 63, subparts
DDDDDD and HHHHHHH.
EPA also notes that, if it had
construed the TSCA section 21 petition
more broadly (i.e., as also seeking
actions to address the manufacturing,
processing, distribution in commerce,
and use of PVC), then the TSCA section
21 petition’s deficiencies would have
been multiplied still further, since there
would have been even more uncertainty
as to the risk management being sought
and, thus, even more uncertainty as to
the existence of an unreasonable risk
that would be necessary to regulate
under TSCA section 6.
Though offering some limited
information (i.e., noting PVC production
volumes, supplying some basic
information on the uses of PVC, and
citing a paper that lists some possible
candidate substitutes for di (2ethylhexyl)phthalate (DEHP), the TSCA
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section 21 petition largely omits the sort
of information that would be relevant to
a cost-benefit and regulatory alternatives
analysis for a proposed rule to require
the substitution of the chemical
substances currently used in the
manufacture of PVC. The TSCA section
21 petition provides almost no
information on the usefulness and
effectiveness of particular substitutes,
their relative toxicity, cost, degree of
availability, and potential to reduce risk.
The TSCA section 21 petition also does
not include any information on the costs
and benefits of regulatory alternatives to
explain why the petitioner believes any
particular risk management action is the
least burdensome requirement that
adequately protects against an
unreasonable risk.
For example, the TSCA section 21
petition lacks a meaningful discussion
of the feasibility and implications of
replacing vinyl chloride, any particular
phthalate currently used as a plasticizer
in PVC, or any particular heat stabilizer
currently used in PVC. While the
petitioner makes a passing reference to
‘‘the availability of less harmful
alternatives,’’ the TSCA section 21
petition does not identify any specific
chemical substance as a reasonable
substitute for any other chemical
substance currently in use in PVC
products. In support of its general
suggestion that ‘‘less harmful
alternatives’’ are available, the TSCA
section 21 petition cites only a single
study, which was itself limited to
reviewing ‘‘candidates’’ for replacing
one specific phthalate (DEHP). The
review itself was, furthermore, limited
to assessing how well the candidate
chemical substances satisfied
leachability criteria (Ref. 4).
EPA published an action plan for
phthalates in 2009. For purposes of the
plan, EPA identified eight phthalates as
appropriate subjects for development of
an assessment and management
strategy: butyl benzyl phthalate (BBP),
dibutyl phthalate (DBP), DEHP,
diisobutyl phthalate (DIBP), diisodecyl
phthalate (DIDP), diisononyl phthalate
(DINP), di-n-pentyl phthalate (DnNPP),
and di-n-octyl phthalate (DnOP). See,
https://www.epa.gov/opptintr/
existingchemicals/pubs/actionplans/
phthalates.html. EPA’s Phthalates
Action Plan (Ref. 5) already observes
that there are ‘‘various possible
alternatives of phthalates in plasticized
PVC.’’ See, https://www.epa.gov/oppt/
existingchemicals/pubs/actionplans/
phthalates_actionplan_revised_2012-0314.pdf. While the study cited by the
petitioner is consistent with EPA’s prior
observation, the TSCA section 21
petition has not set forth facts (e.g.,
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bearing on relative risks, benefits,
utility, and cost) to establish that a
TSCA section 6 rule requiring the
replacement of particular PVC
plasticizers in one or more particular
applications would be necessary.
B. Request for Action Under TSCA
Section 4
Apparently anticipating that EPA
might deny its request to issue a TSCA
section 6 rule on the grounds that there
are not sufficient toxicity data to justify
a section 6 rule, the petitioner asked
EPA to alternatively adopt a rule under
TSCA section 4 requiring manufacturers
and processors of PVC, vinyl chloride,
and phthalate plasticizers ‘‘to undertake
additional toxicity testing.’’
EPA’s denial of the request to issue a
TSCA section 6 rule is not predicated on
a determination that there are
insufficient toxicity data to justify
action under TSCA section 6.
Furthermore, the TSCA section 21
petition’s failure to set forth evidence to
justify the necessity of rulemaking
under TSCA section 6 is not in itself
evidence that the currently available
toxicity information is inadequate. As
noted in Unit IV.A., many of the
information gaps in the submitted TSCA
section 21 petition are either unrelated,
or only indirectly related, to the toxicity
of these chemical substances. And the
petitioner does not contend that its
efforts to explain why rulemaking under
TSCA section 6 is necessary were
impeded by a lack of information about
the toxicity of these chemical
substances.
EPA is denying the request for
rulemaking under TSCA section 4
because the TSCA section 21 petition
does not set forth sufficient facts for
EPA to find that the toxicity information
available to the Agency is insufficient to
permit a reasoned evaluation of the
health or environmental effects of these
chemical substances, or for EPA to
conclude that toxicity testing is
necessary to develop any missing data.
Although the petitioner suggests in
very general terms that ‘‘[non-]
traditional toxicity testing’’ might
produce results showing that these
chemical substances are riskier than
currently known, the petitioner does not
identify any particular deficiency in
what is currently known about the
toxicity of these chemical substances, or
specify what kind of ‘‘non-traditional’’
toxicity tests the petitioner believes are
necessary. Neither does the TSCA
section 21 petition indicate whether
(and if so, why) the petitioner believes
that any deficiencies in the availability
of information about the toxicity of
these chemical substances are
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precluding a reasoned evaluation of
health or environmental effects. Even if
the TSCA section 21 petition had
established that the currently available
toxicity information could be improved
in particular respects for one or more of
these chemical substances, it would not
automatically follow that the currently
available toxicity information is
insufficient to permit a reasoned
evaluation of health or environmental
effects.
VI. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are included
in the docket, even if the referenced
document is not physically located in
the docket. For assistance in locating
these other documents, please consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. CBD. Petition for Rulemaking Pursuant
to Section 7004(a) of the Resource
Conservation and Recovery Act, 42 U.S.C.
§ 6974(A), and Section 21 of the Toxic
Substances Control Act, 15 U.S.C. § 2620,
Concerning the Regulation of Discarded
Polyvinyl Chloride and Associated Chemical
Additives. July 29, 2014.
2. EPA. Lead Fishing Sinkers; Response to
Citizens’ Petition and Proposed Ban;
Proposed Rule. Federal Register (59 FR
11122, March 9, 1994) (FRL–4643–3).
3. EPA. National Emission Standards for
Hazardous Air Pollutants for Polyvinyl
Chloride and Copolymers Production; Final
Rule. Federal Register (77 FR 22848, April
17, 2012) (FRL–9636–2).
4. Kastner et al. Aqueous leaching of di-2ethylhexyl phthalate and ‘green’ plasticizers
from poly(vinyl chloride). Science of the
Total Environment. p. 432. 2012.
5. EPA. Phthalates Action Plan. Revised.
March 14, 2012.
List of Subjects in Chapter I
Environmental protection, Hazardous
substances, Phthalates, Plasticizers,
Polyvinyl chloride, Vinyl chloride.
Dated: October 24, 2014.
James Jones,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2014–25849 Filed 10–30–14; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Proposed Rules]
[Pages 64722-64725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25849]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter I
[EPA-HQ-OPPT-2014-0684; FRL-9918-27]
Discarded Polyvinyl Chloride; TSCA Section 21 Petition; Reasons
for Agency Response
AGENCY: Environmental Protection Agency (EPA).
ACTION: Petition; reasons for Agency response.
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SUMMARY: This document announces the availability of EPA's response to
a petition it received under the Toxic Substances Control Act (TSCA).
The TSCA section 21 petition was received from the Center for
Biological Diversity (CBD) on July 29, 2014. The petitioner requested
that EPA initiate rulemaking under TSCA to address risks related to
polyvinyl chloride (PVC), vinyl chloride, and phthalates used as
plasticizers. The petitioner alternatively requested that EPA initiate
rulemaking under TSCA to require additional toxicity testing of these
chemical substances. After careful consideration, EPA has denied the
TSCA section 21 petition for the reasons discussed in this document.
The TSCA section 21 petition was accompanied by an independent petition
for EPA to take action under the authority of the Resource Conservation
and Recovery Act (RCRA). EPA continues to review the petitioner's
requests for action under RCRA.
DATES: EPA's response to this TSCA section 21 petition was signed
October 24, 2014..
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Paul Lewis, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-6738; email address: lewis.paul@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@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 produce, or who use PVC,
vinyl chloride, or phthalates used as plasticizers, or substitutes for
such chemical substances. Since many other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action.
B. How can I access information about this TSCA section 21 petition?
The docket for this TSCA section 21 petition, identified by docket
identification (ID) number EPA-HQ-OPPT-2014-0684, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
II. TSCA Section 21
A. What is a TSCA section 21 petition?
Under TSCA section 21 (15 U.S.C. 2620), any person can 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.
15 U.S.C. 2620(b)(3). 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. 15 U.S.C. 2620(b)(4).
B. What criteria apply to a decision on a TSCA section 21 petition?
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 TSCA section 21
petition.
III. TSCA Sections 6 and 4
Of particular relevance to this TSCA section 21 petition are the
legal standards regarding TSCA section 6 rules and TSCA section 4
rules.
A. TSCA Section 6 Rules
To promulgate a rule under TSCA section 6, the EPA 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.
[[Page 64723]]
2605(a). This finding cannot be made considering risk alone. Under TSCA
section 6, a finding of ``unreasonable risk'' requires the
consideration of costs and benefits. 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).
In addition, TSCA section 21(b)(4)(B) 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 EPA Administrator to
initiate the requested action. 15 U.S.C. 2620(b)(4)(B). Also relevant
to the issuance of regulations under TSCA section 6, TSCA section 9(b)
directs EPA to take regulatory action on a chemical substance or
mixture under other statutes administered by the Agency if the EPA
Administrator determines that actions under those statutes could
eliminate or reduce to a sufficient extent a risk posed by the chemical
substance or mixture. If this is the case, the regulation under TSCA
section 6 can be promulgated only if the EPA determines that it is in
the ``public interest'' to protect against that risk under TSCA rather
than the alternative authority. 15 U.S.C. 2608(b).
B. TSCA Section 4 Rules
To promulgate a rule under TSCA section 4, EPA must make several
findings. In all cases, EPA must find that data and experience are
insufficient to reasonably determine or predict the effects of a
chemical substance or mixture on health or the environment and that
testing of the chemical substance is necessary to develop the missing
data. 15 U.S.C. 2603(a)(1). In addition, EPA must find either that:
1. The chemical substance or mixture may present an unreasonable
risk of injury or
2. The chemical substance is produced in substantial quantities and
may either result in significant or substantial human exposure or
result in substantial environmental release. 15 U.S.C. 2603(a)(1).
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).
IV. Summary of the TSCA Section 21 Petition
A. What action was requested?
On July 29, 2014, the CBD submitted to EPA a ``Petition for
Rulemaking Pursuant to Section 7004(a) of the Resource Conservation and
Recovery Act, 42 U.S.C. 6974(A), and Section 21 of the Toxic Substances
Control Act, 15 U.S.C. 2620, Concerning the Regulation of Discarded
Polyvinyl Chloride and Associated Chemical Additives'' (Ref. 1). (The
petitioner stated that it was submitting two ``independent and fully
severable'' petitions: One under RCRA and another under TSCA. At this
time, EPA is only responding to the TSCA section 21 petition. EPA
continues to review the petitioner's requests for action under RCRA.)
The TSCA section 21 petition states that it is requesting issuance
of ``regulations governing the safe treatment, storage and disposal of
polyvinyl chloride (``PVC''), vinyl chloride and associated dialkyl-
and alkylarylesters of 1,2-benzenedicarboxylic acid, commonly known as
phthalate plasticizers.'' In its conclusion, the petitioner urges EPA
to ``promptly exercise its authority to ensure the safe disposal of
discarded PVC.''
The petitioner requested that EPA initiate rulemaking under TSCA
section 6 ``to reduce the unreasonable risk to public health and the
environment associated with continued dependence'' on PVC, vinyl
chloride, and phthalates used as plasticizers. The petitioner also
alternatively requested that EPA take action under TSCA section 4
``requiring manufacturers and processors responsible for the generation
of these compounds to undertake additional toxicity testing'' if ``the
Agency concludes that there are insufficient data and experience upon
which to determine or predict the effects of ubiquitous contamination''
for purposes of making a TSCA section 6 determination.
EPA interprets the TSCA section 21 petition as requesting EPA to
initiate a proceeding for the issuance of a rule under TSCA section 6
to address risks related to the disposal of PVC. The TSCA section 21
petition is unclear about whether it is referring to PVC resins or PVC-
based products, but, due to its emphasis on risks created by widespread
disposal, EPA assumes the TSCA section 21 petition is about PVC-based
products (i.e., plastics manufactured from PVC resin). EPA therefore
interprets the TSCA section 21 petition as arguing that TSCA regulation
of the disposal of PVC-based products is necessary in order to address
certain post-disposal risks (including risks relating to chemical
substances that the petitioner believes could be released by PVC-based
products after disposal).
Due to a lack of specificity regarding the particular action
requested, and other grounds described in Unit V., EPA denied the TSCA
section 21 petition to initiate rulemaking under TSCA section 6 to
address risks from the disposal of PVC. As a part of its analysis, EPA
also considered whether a broader interpretation of the TSCA section 21
petition, as furthermore requesting regulation of the manufacture,
processing, distribution, or use of PVC, would have altered the
Agency's decision. EPA considered whether the facts set forth in the
TSCA section 21 petition established that it was necessary to initiate
TSCA section 6 rulemaking to ban or otherwise limit any specific use of
PVC or vinyl chloride, phthalates as plasticizers, or metal-based heat
stabilizers in manufacturing PVC as a means of reducing the quantities
of such chemical substances that enter the disposal stream in the first
place. As described in Unit V., EPA concluded that, under such a
broader interpretation, EPA would have denied the TSCA section 21
petition on similar grounds. The TSCA section 21 petition does not
clearly state a pre-disposal risk management action that is sought, let
alone demonstrate a risk that is unreasonable.
Finally, EPA notes that it did not construe the petitioner's
request for rulemaking under TSCA section 4 as a strictly contingent
request, which EPA would only consider if it had previously reached
particular factual conclusions on its own initiative (i.e., ``that
there are insufficient data and experience upon which to determine or
predict the effects of ubiquitous contamination''). Therefore, no
inference of implicit agreement with such conclusions should be drawn
from the fact that EPA has reviewed whether the TSCA section 21
petition itself sets forth facts sufficient to justify the initiation
of rulemaking to require toxicity testing under TSCA section 4.
B. What support does the petitioner offer?
The petitioner states that PVC, vinyl chloride, and phthalates used
as plasticizers pose ``significant threats'' to human health and the
environment. While the TSCA section 21 petition
[[Page 64724]]
includes information on other chemical substances related to PVC (e.g.,
stating that vinyl chloride is also a concern), it focuses on the use
of phthalates as plasticizers in PVC. The TSCA section 21 petition
states that phthalates are the most abundant manmade chemicals in the
environment and that ``virtually universal'' exposure to phthalates
``could be the leading cause'' of human reproductive disorders. The
petitioner expresses concern that ``these compounds'' bioaccumulate in
living organisms, interfere with hormone regulation, and alter sexual
development. The petitioner also expresses concern that ``human
contamination probably exceeds previously published estimates'' and
that harm might be occurring from ``exposure pathways outside the scope
of traditional toxicity testing,'' such as ``synergistic'' effects from
``multiple phthalates'' or other pollutants. Finally, citing a single
study, the petitioner also states that ``less harmful alternatives'' to
these chemical substances are available.
V. Disposition of TSCA Section 21 Petition
After careful consideration, EPA denied the petitioner's request to
initiate a TSCA section 6 rulemaking, because the TSCA section 21
petition does not:
Specify what risk management action it is requesting,
Set forth sufficient facts to establish that the disposal
of PVC, vinyl chloride, or phthalates used as plasticizers presents or
will present an unreasonable risk, or
Explain why action under TSCA would be preferable to
action under other statutory authorities.
EPA also denied the petitioner's request to initiate a TSCA section
4 rulemaking to require further toxicity testing of PVC, vinyl
chloride, or phthalates used as plasticizers, because the TSCA section
21 petition does not set forth sufficient facts for EPA to find that
the toxicity information available to the Agency is insufficient to
permit a reasoned evaluation of the health or environmental effects of
these PVC constituents, or for EPA to conclude that toxicity testing is
necessary to develop any missing data.
A. Request for a Rule Under TSCA Section 6
With respect to its request that EPA initiate a proceeding for the
issuance of a rule under TSCA section 6 to address risks related to the
manner of disposal of PVC, the TSCA section 21 petition's primary
deficiencies are its failure to specify the risk management action
sought and its failure to discuss several major issues intrinsic to an
unreasonable risk determination (i.e., risk reduction that would be
accomplished by such action and the reasonably ascertainable economic
and other social consequences of the action).
Section 21 of TSCA authorizes any person to petition EPA for the
``issuance . . . of a rule'' under TSCA section 6. As EPA interprets
this provision, asking for a rule entails telling EPA, with reasonable
specificity, what action is sought in the TSCA section 21 petition.
Simply citing to general legal authority and stating a desired outcome
does not define an action, and thus fails this threshold requirement
under TSCA section 21. EPA's interpretation is consistent with the
short 90-day deadline for responding to such rulemaking petitions, as
well as with TSCA's grant of de novo judicial review to petitioners. In
any such proceeding, it would be necessary to supply the court with a
specific description of the relief sought to inform any requested
injunction that EPA ``initiate the action requested by the
petitioner.'' See 15 U.S.C. 2620(b)(4)(B). Since the court's de novo
review is itself a rehearing of the Agency's prior review of the TSCA
section 21 petition, it follows that the TSCA section 21 petition
itself must supply the specific description of the relief sought.
Although the TSCA section 21 petition asserts that ``the inadequate
management of PVC, vinyl chloride, and phthalate plasticizers poses
significant threats to human and ecosystem health,'' the petitioner's
argument as to the existence of unreasonable risk is hindered by a
nearly complete lack of detail as to the TSCA risk management that it
is seeking. While the petitioner stated the overall outcome that it
hoped could be achieved (reduce risk to human health and the
environment from the disposal of PVC), the petitioner did not state, in
any reasonable manner, what action available under TSCA section 6 it
sought in order to achieve that outcome.
The TSCA section 21 petition, furthermore, failed to set forth
sufficient facts bearing on the relative risk reduction and the
reasonably ascertainable economic and other social consequences of the
unspecified risk management action. These issues are integral to EPA's
assessment of whether rulemaking under TSCA section 6 is necessary and,
even more fundamentally, its assessment of whether a particular risk is
in fact an unreasonable risk. This is because the finding of
unreasonable risk is a judgement under which the decisionmaker
determines that the risk of health or environmental injury from the
chemical substance or mixture outweighs the burden to society of
potential regulations (Ref. 2). Because the TSCA section 21 petition
omits discussion of multiple issues that are intrinsic to the finding
of unreasonable risk, the TSCA section 21 petition fails to set forth
sufficient facts to establish that the disposal of PVC, vinyl chloride,
or phthalates used as plasticizers presents or will present an
unreasonable risk.
Finally, while the petitioner acknowledges that PVC disposal might
also be regulated under other EPA statutory authorities, such as RCRA,
it has not explained why it believes it would be preferable to address
the risks of disposal under TSCA, rather than through other statutory
authorities. The petitioner's views on this question are especially
difficult to infer given the absence of information about the
particular TSCA risk management action sought. This omission is an
impediment to assessing whether a TSCA section 6 rule would be an
appropriate means of reducing potential risks related to the disposal
of PVC, and (if so) how such action could be coordinated, consistent
with TSCA section 9(b), with other actions that EPA has already taken
with respect to these chemical substances under other statutes that EPA
administers.
For example, the petitioner did not explain why it believes vinyl
chloride poses an unreasonable risk that should be addressed under TSCA
despite the impact of multiple rules regulating this chemical substance
under the Clean Air Act (42 U.S.C. 7400 et seq.), including one that
was recently established in 2012 (Ref. 3). See 40 CFR part 61, subpart
F, and 40 CFR part 63, subparts DDDDDD and HHHHHHH.
EPA also notes that, if it had construed the TSCA section 21
petition more broadly (i.e., as also seeking actions to address the
manufacturing, processing, distribution in commerce, and use of PVC),
then the TSCA section 21 petition's deficiencies would have been
multiplied still further, since there would have been even more
uncertainty as to the risk management being sought and, thus, even more
uncertainty as to the existence of an unreasonable risk that would be
necessary to regulate under TSCA section 6.
Though offering some limited information (i.e., noting PVC
production volumes, supplying some basic information on the uses of
PVC, and citing a paper that lists some possible candidate substitutes
for di (2-ethylhexyl)phthalate (DEHP), the TSCA
[[Page 64725]]
section 21 petition largely omits the sort of information that would be
relevant to a cost-benefit and regulatory alternatives analysis for a
proposed rule to require the substitution of the chemical substances
currently used in the manufacture of PVC. The TSCA section 21 petition
provides almost no information on the usefulness and effectiveness of
particular substitutes, their relative toxicity, cost, degree of
availability, and potential to reduce risk. The TSCA section 21
petition also does not include any information on the costs and
benefits of regulatory alternatives to explain why the petitioner
believes any particular risk management action is the least burdensome
requirement that adequately protects against an unreasonable risk.
For example, the TSCA section 21 petition lacks a meaningful
discussion of the feasibility and implications of replacing vinyl
chloride, any particular phthalate currently used as a plasticizer in
PVC, or any particular heat stabilizer currently used in PVC. While the
petitioner makes a passing reference to ``the availability of less
harmful alternatives,'' the TSCA section 21 petition does not identify
any specific chemical substance as a reasonable substitute for any
other chemical substance currently in use in PVC products. In support
of its general suggestion that ``less harmful alternatives'' are
available, the TSCA section 21 petition cites only a single study,
which was itself limited to reviewing ``candidates'' for replacing one
specific phthalate (DEHP). The review itself was, furthermore, limited
to assessing how well the candidate chemical substances satisfied
leachability criteria (Ref. 4).
EPA published an action plan for phthalates in 2009. For purposes
of the plan, EPA identified eight phthalates as appropriate subjects
for development of an assessment and management strategy: butyl benzyl
phthalate (BBP), dibutyl phthalate (DBP), DEHP, diisobutyl phthalate
(DIBP), diisodecyl phthalate (DIDP), diisononyl phthalate (DINP), di-n-
pentyl phthalate (DnNPP), and di-n-octyl phthalate (DnOP). See, https://www.epa.gov/opptintr/existingchemicals/pubs/actionplans/phthalates.html. EPA's Phthalates Action Plan (Ref. 5) already observes
that there are ``various possible alternatives of phthalates in
plasticized PVC.'' See, https://www.epa.gov/oppt/existingchemicals/pubs/actionplans/phthalates_actionplan_revised_2012-03-14.pdf. While the
study cited by the petitioner is consistent with EPA's prior
observation, the TSCA section 21 petition has not set forth facts
(e.g., bearing on relative risks, benefits, utility, and cost) to
establish that a TSCA section 6 rule requiring the replacement of
particular PVC plasticizers in one or more particular applications
would be necessary.
B. Request for Action Under TSCA Section 4
Apparently anticipating that EPA might deny its request to issue a
TSCA section 6 rule on the grounds that there are not sufficient
toxicity data to justify a section 6 rule, the petitioner asked EPA to
alternatively adopt a rule under TSCA section 4 requiring manufacturers
and processors of PVC, vinyl chloride, and phthalate plasticizers ``to
undertake additional toxicity testing.''
EPA's denial of the request to issue a TSCA section 6 rule is not
predicated on a determination that there are insufficient toxicity data
to justify action under TSCA section 6. Furthermore, the TSCA section
21 petition's failure to set forth evidence to justify the necessity of
rulemaking under TSCA section 6 is not in itself evidence that the
currently available toxicity information is inadequate. As noted in
Unit IV.A., many of the information gaps in the submitted TSCA section
21 petition are either unrelated, or only indirectly related, to the
toxicity of these chemical substances. And the petitioner does not
contend that its efforts to explain why rulemaking under TSCA section 6
is necessary were impeded by a lack of information about the toxicity
of these chemical substances.
EPA is denying the request for rulemaking under TSCA section 4
because the TSCA section 21 petition does not set forth sufficient
facts for EPA to find that the toxicity information available to the
Agency is insufficient to permit a reasoned evaluation of the health or
environmental effects of these chemical substances, or for EPA to
conclude that toxicity testing is necessary to develop any missing
data.
Although the petitioner suggests in very general terms that ``[non-
] traditional toxicity testing'' might produce results showing that
these chemical substances are riskier than currently known, the
petitioner does not identify any particular deficiency in what is
currently known about the toxicity of these chemical substances, or
specify what kind of ``non-traditional'' toxicity tests the petitioner
believes are necessary. Neither does the TSCA section 21 petition
indicate whether (and if so, why) the petitioner believes that any
deficiencies in the availability of information about the toxicity of
these chemical substances are precluding a reasoned evaluation of
health or environmental effects. Even if the TSCA section 21 petition
had established that the currently available toxicity information could
be improved in particular respects for one or more of these chemical
substances, it would not automatically follow that the currently
available toxicity information is insufficient to permit a reasoned
evaluation of health or environmental effects.
VI. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. CBD. Petition for Rulemaking Pursuant to Section 7004(a) of
the Resource Conservation and Recovery Act, 42 U.S.C. Sec. 6974(A),
and Section 21 of the Toxic Substances Control Act, 15 U.S.C. Sec.
2620, Concerning the Regulation of Discarded Polyvinyl Chloride and
Associated Chemical Additives. July 29, 2014.
2. EPA. Lead Fishing Sinkers; Response to Citizens' Petition and
Proposed Ban; Proposed Rule. Federal Register (59 FR 11122, March 9,
1994) (FRL-4643-3).
3. EPA. National Emission Standards for Hazardous Air Pollutants
for Polyvinyl Chloride and Copolymers Production; Final Rule.
Federal Register (77 FR 22848, April 17, 2012) (FRL-9636-2).
4. Kastner et al. Aqueous leaching of di-2-ethylhexyl phthalate
and `green' plasticizers from poly(vinyl chloride). Science of the
Total Environment. p. 432. 2012.
5. EPA. Phthalates Action Plan. Revised. March 14, 2012.
List of Subjects in Chapter I
Environmental protection, Hazardous substances, Phthalates,
Plasticizers, Polyvinyl chloride, Vinyl chloride.
Dated: October 24, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2014-25849 Filed 10-30-14; 8:45 am]
BILLING CODE 6560-50-P