Addition of Nonylphenol Category; Community Right-to-Know Toxic Chemical Release Reporting, 37176-37186 [2013-14754]
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Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Proposed Rules
TABLE 2B TO APPENDIX A OF SUBPART A—DATA ELEMENTS FOR REPORTING EMISSIONS FROM POINT, NONPOINT,
ONROAD MOBILE AND NONROAD MOBILE SOURCES, WHERE REQUIRED BY 40 CFR 51.30—Continued
Data elements
Point
Nonpoint
Onroad
Nonroad
(18) Percent Control Approach Penetration (where applicable) .....................................
....................
Y
....................
....................
12. Amend § 51.122 by:
a. Revising paragraph (c);
b. Removing and reserving paragraph
(d); and
■ c. Revising paragraph (f).
The revisions read as follows:
■
■
■
§ 51.122 Emissions reporting
requirements for SIP revisions relating to
budgets for NOX emissions.
*
*
*
*
*
(c) Each revision must provide for
periodic reporting by the state of NOX
emissions data to demonstrate whether
the state’s emissions are consistent with
the projections contained in its
approved SIP submission. The data
availability requirements in § 51.116
must be followed for all data submitted
to meet the requirements of paragraph
(c) of this section.
*
*
*
*
*
(f) Reporting schedules. Data
collection is to begin during the ozone
season 1 year prior to the state’s NOX
SIP Call compliance date.
[FR Doc. 2013–14628 Filed 6–19–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2013–0362; FRL–9815–4]
Revisions to the California State
Implementation Plan, San Diego Air
Pollution Control District
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to approve
a revision to the San Diego Air Pollution
Control District (SDAPCD) portion of
the California State Implementation
Plan (SIP). This revision concerns
volatile organic compound (VOC)
emissions from architectural coatings.
We are proposing to approve a local rule
to regulate these emission sources under
the Clean Air Act (CAA or the Act).
DATES: Any comments on this proposal
must arrive by July 22, 2013.
ADDRESSES: Submit comments,
identified by docket number EPA–R09–
OAR–2013–0362, by one of the
following methods:
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SUMMARY:
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1. Federal eRulemaking Portal:
www.regulations.gov. Follow the on-line
instructions.
2. Email: steckel.andrew@epa.gov.
3. Mail or deliver: Andrew Steckel
(Air-4), U.S. Environmental Protection
Agency Region IX, 75 Hawthorne Street,
San Francisco, CA 94105–3901.
Instructions: All comments will be
included in the public docket without
change and may be made available
online at www.regulations.gov,
including any personal information
provided, unless the comment includes
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Information that
you consider CBI or otherwise protected
should be clearly identified as such and
should not be submitted through
www.regulations.gov or email.
www.regulations.gov is an ‘‘anonymous
access’’ system, and EPA will not know
your identity or contact information
unless you provide it in the body of
your comment. If you send email
directly to EPA, your email address will
be automatically captured and included
as part of the public comment. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: Generally, documents in the
docket for this action are available
electronically at www.regulations.gov
and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco,
California 94105–3901. While all
documents in the docket are listed at
www.regulations.gov, some information
may be publicly available only at the
hard copy location (e.g., copyrighted
material, large maps), and some may not
be publicly available in either location
(e.g., CBI). To inspect the hard copy
materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT:
Nicole Law, EPA Region IX, (415) 947–
4126, law.nicole@epa.gov.
SUPPLEMENTARY INFORMATION: This
proposal addresses the following local
rule: San Diego APCD Rule 67.0
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Architectural Coatings. In the Rules and
Regulations section of this Federal
Register, we are approving this local
rule in a direct final action without
prior proposal because we believe this
SIP revision is not controversial. If we
receive adverse comments, however, we
will publish a timely withdrawal of the
direct final rule and address the
comments in subsequent action based
on this proposed rule. Please note that
if we receive adverse comment on an
amendment, paragraph, or section of
this rule and if that provision may be
severed from the remainder of the rule,
we may adopt as final those provisions
of the rule that are not the subject of an
adverse comment.
We do not plan to open a second
comment period, so anyone interested
in commenting should do so at this
time. If we do not receive adverse
comments, no further activity is
planned. For further information, please
see the direct final action.
Dated: May 6, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2013–14514 Filed 6–19–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 372
[EPA–HQ–TRI–2012–0110; FRL–9819–1]
RIN 2025–AA34
Addition of Nonylphenol Category;
Community Right-to-Know Toxic
Chemical Release Reporting
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to add a
nonylphenol category to the list of toxic
chemicals subject to reporting under
section 313 of the Emergency Planning
and Community Right-to-Know Act
(EPCRA) of 1986 and section 6607 of the
Pollution Prevention Act (PPA) of 1990.
EPA is proposing to add this chemical
category to the EPCRA section 313 list
pursuant to its authority to add
chemicals and chemical categories
because EPA believes this category
meets the EPCRA section 313(d)(2)(C)
SUMMARY:
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toxicity criterion. Based on a review of
the available production and use
information, the members of the
nonylphenol category are expected to be
manufactured, processed, or otherwise
used in quantities that would exceed the
EPCRA section 313 reporting
thresholds.
Comments must be received on
or before August 19, 2013.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
TRI–2012–0110, by one of the following
methods:
• www.regulations.gov: Follow the
on-line instructions for submitting
comments.
• Email: oei.docket@epa.gov.
• Mail: Office of Environmental
Information (OEI) Docket,
Environmental Protection Agency, Mail
Code: 28221T, 1200 Pennsylvania Ave.
NW., Washington, DC 20460
• Hand Delivery: EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC
20460. Such deliveries are only
accepted during the Docket’s normal
hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–TRI–2012–
0110. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
DATES:
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or email. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an email
comment directly to EPA without going
through www.regulations.gov, your
email address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, avoid any
form of encryption, and be free of any
defects or viruses.
Docket: All documents in the docket
are listed in the www.regulations.gov
index. Although listed in the index,
some information is not publicly
available, e.g., 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
37177
either electronically in
www.regulations.gov or in hard copy at
the OEI Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave.
NW., Washington, DC. This Docket
Facility 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 OEI Docket is (202) 566–1752.
FOR FURTHER INFORMATION CONTACT:
Daniel R. Bushman, Environmental
Analysis Division, Office of Information
Analysis and Access (2842T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460; telephone number: 202–566–
0743; fax number: 202–566–0677; email:
bushman.daniel@epa.gov, for specific
information on this notice. For general
information on EPCRA section 313,
contact the Emergency Planning and
Community Right-to-Know Hotline, toll
free at (800) 424–9346 (select menu
option 3) or (703) 412–9810 in Virginia
and Alaska or toll free, TDD (800) 553–
7672, https://www.epa.gov/superfund/
contacts/infocenter/.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this notice apply to me?
You may be potentially affected by
this action if you manufacture, process,
or otherwise use nonylphenol.
Potentially affected categories and
entities may include, but are not limited
to:
Category
Examples of potentially affected entities
Industry ...............................
Facilities included in the following NAICS manufacturing codes (corresponding to SIC codes 20 through 39): 311*,
312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*,
111998*, 211112*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120, 511130, 511140*, 511191,
511199, 512220, 512230*, 519130*, 541712*, or 811490*. *Exceptions and/or limitations exist for these NAICS
codes. Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20
through 39): 212111, 212112, 212113 (correspond to SIC 12, Coal Mining (except 1241)); or 212221, 212222,
212231, 212234, 212299 (correspond to SIC 10, Metal Mining (except 1011, 1081, and 1094)); or 221111,
221112, 221113, 221119, 221121, 221122, 221330 (Limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce) (correspond to SIC 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120 (Limited to facilities previously classified in SIC 5169, Chemicals and Allied
Products, Not Elsewhere Classified); or 424710 (corresponds to SIC 5171, Petroleum Bulk Terminals and
Plants); or 562112 (Limited to facilities primarily engaged in solvent recovery services on a contract or fee basis
(previously classified under SIC 7389, Business Services, NEC)); or 562211, 562212, 562213, 562219, 562920
(Limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et
seq.) (correspond to SIC 4953, Refuse Systems).
Federal facilities.
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Federal Government ..........
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Some of the
entities listed in the table have
exemptions and/or limitations regarding
coverage, and other types of entities not
listed in the table could also be affected.
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To determine whether your facility
would be affected by this action, you
should carefully examine the
applicability criteria in part 372 subpart
B of Title 40 of the Code of Federal
Regulations. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
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listed in the preceding FOR FURTHER
section.
INFORMATION CONTACT
B. How should I submit CBI to the
Agency?
Do not submit CBI information to EPA
through www.regulations.gov or email.
Clearly mark the part or all of the
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Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Proposed Rules
information that you claim to be CBI.
For CBI information in a disk or CD–
ROM that you mail to EPA, mark the
outside of the disk or CD–ROM as CBI
and then identify electronically within
the disk or CD–ROM the specific
information that is claimed as CBI. In
addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
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II. Introduction
Section 313 of EPCRA, 42 U.S.C.
11023, requires certain facilities that
manufacture, process, or otherwise use
listed toxic chemicals in amounts above
reporting threshold levels to report their
environmental releases and other waste
management quantities of such
chemicals annually. These facilities
must also report pollution prevention
and recycling data for such chemicals,
pursuant to section 6607 of the PPA, 42
U.S.C. 13106. Congress established an
initial list of toxic chemicals that
comprised more than 300 chemicals and
20 chemical categories.
EPCRA section 313(d) authorizes EPA
to add or delete chemicals from the list
and sets criteria for these actions.
EPCRA section 313(d)(2) states that EPA
may add a chemical to the list if any of
the listing criteria in Section 313(d)(2)
are met. Therefore, to add a chemical,
EPA must demonstrate that at least one
criterion is met, but need not determine
whether any other criterion is met. The
EPCRA section 313(d)(2) criteria are:
(A) The chemical is known to cause
or can reasonably be anticipated to
cause significant adverse acute human
health effects at concentration levels
that are reasonably likely to exist
beyond facility site boundaries as a
result of continuous, or frequently
recurring, releases.
(B) The chemical is known to cause or
can reasonably be anticipated to cause
in humans:
(i) Cancer or teratogenic effects, or
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(ii) serious or irreversible—
(I) reproductive dysfunctions,
(II) neurological disorders,
(III) heritable genetic mutations, or
(IV) other chronic health effects.
(C) The chemical is known to cause or
can be reasonably anticipated to cause,
because of:
(i) Its toxicity,
(ii) its toxicity and persistence in the
environment, or
(iii) its toxicity and tendency to
bioaccumulate in the environment, a
significant adverse effect on the
environment of sufficient seriousness,
in the judgment of the Administrator, to
warrant reporting under this section.
EPA often refers to the section
313(d)(2)(A) criterion as the ‘‘acute
human health effects criterion;’’ the
section 313(d)(2)(B) criterion as the
‘‘chronic human health effects
criterion;’’ and the section 313(d)(2)(C)
criterion as the ‘‘environmental effects
criterion.’’
EPA published in the Federal
Register of November 30, 1994 (59 FR
61432) a statement clarifying its
interpretation of the section 313(d)(2)
and (d)(3) criteria for modifying the
section 313 list of toxic chemicals.
III. Background Information
A. What is nonylphenol?
Nonylphenol is an organic chemical
whose main use is in the manufacture
of nonylphenol ethoxylates, which are
nonionic surfactants used in a wide
variety of industrial applications and
consumer products (Reference (Ref.) 1).
Nonylphenol is persistent in the aquatic
environment, moderately
bioaccumulative, and extremely toxic to
aquatic organisms (Ref. 1). Nonylphenol
has also been detected in human breast
milk, blood, and urine (Ref. 1).
B. What is the chemical structure and
identification of nonylphenol?
The chemical structure of
nonylphenol consists of a phenol ring
(benzene with a hydroxyl (OH) group)
with a nonyl group (a nine carbon alkyl
chain) attached to the phenol ring. The
nonyl group can either be a branched or
linear chain located at various positions
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on the phenol ring (primarily the ortho
(2) and para (4) positions). Nonylphenol
is not a single chemical structure.
Rather it is a complex mixture of highly
branched nonylphenols, mostly monosubstituted in the para position (i.e., the
4 position), with small amounts of
ortho- and di-substituted nonylphenols.
In addition, nonylphenol can include
small amounts of branched 8 carbon and
10 carbon alkyl groups (Ref. 2).
As noted in EPA’s Action Plan for
nonylphenol (Ref. 1), Chemical Abstract
Service Registry Numbers (CASRNs)
that are routinely used for nonylphenols
may not accurately reflect the identity of
those substances. Manufacturers may
incorrectly use a linear identity when
actually referring to branched
nonylphenol. CASRN 84852–15–3
corresponds to the most widely
produced nonylphenol, branched 4nonylphenol. Much of the literature
refers to the linear (or normal)
nonylphenol (CASRN 25154–52–3) and
there are also references to a specific
linear para isomer 4-n-nonylphenol
(CASRN 104–40–5), which is covered
within the broader CASRN 25154–52–3.
Many, but not all, references may be
inaccurate about the identity of the
substances listed as nonylphenol due to
inaccurate identities in the source
material. A supplier of nonylphenol
may use CASRN 104–40–5, signifying
the linear 4-n-nonylphenol, while
actually supplying branched 4nonylphenol (CASRN 84852–15–3). The
name 4-nonylphenol is listed as a
synonym under CASRN 104–40–5,
which may lead to such confusion.
C. How is EPA proposing to list
nonylphenol on the TRI?
Because there is no one CASRN that
adequately captures what is referred to
as nonylphenol and because of the
apparent confusion that has resulted
from the use of multiple CASRNs, EPA
is proposing to add nonylphenol as a
category defined by a structure. EPA is
proposing to define the nonylphenol
category using the structure and text
presented below.
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This category definition covers the
chemicals that are included in CASRNs
84852–15–3 as well as those 4 position
isomers covered by CASRN 25154–52–
3. Any nonylphenol that meets the
above category definition would be
reportable regardless of its assigned
CASRN.
IV. What Is EPA’s evaluation of the
environmental toxicity of nonylphenol?
Nonylphenol is toxic to aquatic
organisms and has been found in
ambient waters. Because of
nonylphenol’s toxicity, chemical
properties, and widespread use as a
chemical intermediate, concerns have
been raised over the potential risks to
aquatic organisms from exposure to
nonylphenol. All of the hazard
information presented here has been
adapted from EPA’s 2005 Water Quality
Criteria document for nonylphenol,
which was previously peer reviewed
(Ref. 3).
A. Acute Toxicity to Aquatic Animals
1. Freshwater Species. The acute
toxicity values of nonylphenol to
freshwater organisms are shown in
Table 1. Acute toxicities have been
determined for more than 18 species
representing over 15 genera. Toxicity
values ranged from 21 micrograms per
liter (mg/L) for a detritivorous amphipod
(Hyalella aztecta) to 774 mg/L for an
algal grazing snail (Physella virgata)
(Ref. 4). No relationships were found
between nonylphenol toxicity and water
hardness or pH.
An amphipod (Hyalella azteca) was
the most sensitive species tested with
LC50 values (i.e., the concentration that
is lethal to 50% of test organisms)
ranging from 21 to 150 mg/L (Refs. 4 and
37179
5). Reported EC50 values (i.e., the
concentration that is effective in
producing a sublethal response in 50%
of test organisms) for the water flea
(Daphnia magna) ranged from 104 to
190 mg/L in renewal and static tests
respectively (Refs. 4 and 6). The overall
mean acute value for Daphnia magna
was 141 mg/L.
Species least sensitive to nonylphenol
were also invertebrates. An annelid
worm (Lumbriculus variegatus) had an
LC50 of 342 mg/L, while the acute
endpoint for a dragonfly nymph
(Ophiogomphus sp.) was an LC50 of 596
mg/L (Ref. 4). The least sensitive species
tested was a snail (Physella virgata) with
an LC50 of 774 mg/L. Eleven species of
fish were tested and found to be in the
mid-range of sensitivity to nonylphenol
with acute values ranging from 110 to
360 mg/L.
TABLE 1—ACUTE TOXICITY OF NONYLPHENOL TO FRESHWATER ORGANISMS
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Common name
Hyalella azteca (juvenile, 2 mm total length) ................
Daphnia magna (< 24 hr old) ........................................
Etheostoma rubrum (0.062g, 20.2 mm) ........................
Bufo boreas (0.012g, 9.6 mm) ......................................
Pimephales promelas (25–35 days old) .......................
Oncorhynchus mykiss (0.27 ± 0.07g) ...........................
Oncorhynchus clarki henshawi (0.34 ± 0.08g) ..............
Pimephales promelas (32 days old) ..............................
Hyalella azteca (juvenile, 2–3mm total length) .............
Oncorhynchus clarki stomais (0.31 ± 0.17g) ................
Chironomus tentans (2nd instar) ...................................
Oncorhynchus mykiss (0.48 ± 0.08g) ...........................
Oncorhynchus apache (0.38 ± 0.18g) ...........................
Xyrauchen texanus (0.31 ± 0.04g) ................................
Pimephales promelas (0.34 ± 0.24g) ............................
Oncorhynchus mykiss (0.50 ± 0.21g) ...........................
Oncorhynchus apache (0.85 ± 0.49g) ...........................
Daphnia magna (< 24 hr old) ........................................
Oncorhynchus mykiss (0.67 ± 0.35g) ...........................
Xyrauchen texanus (0.32 ± 0.07g) ................................
Etheostoma lepidum (0.133g, 22.6 mm) .......................
Lepomis macrochirus (juvenile) ....................................
Pimephales promelas (0.32 ± 0.16g) ............................
Oncorhynchus clarki henshawi (0.57 ± 0.23g) ..............
Oncorhynchus mykiss (45 days old) .............................
Poeciliopsis occidentalis (0.22g, 27.2 mm) ...................
Ptychocheilus lucius (0.32 ± 0.05g) ..............................
Oncorhynchus mykiss (1.25 ± 0.57g) ...........................
Amphipod ..........................
Water Flea .........................
Fountain Darter .................
Boreal Toad .......................
Fathead Minnow ................
Rainbow Trout ...................
Lahontan Cutthroat Trout ..
Fathead Minnow ................
Amphipod ..........................
Greenback Cutthroat Trout
Midge .................................
Rainbow Trout ...................
Apache Trout .....................
Razorback Sucker .............
Fathead Minnow ................
Rainbow Trout ...................
Apache Trout .....................
Water Flea .........................
Rainbow Trout ...................
Razorback Sucker .............
Greenthroat Darter ............
Bluegill ...............................
Fathead Minnow ................
Lahontan Cutthroat Trout ..
Rainbow Trout ...................
Gila Topminnow ................
Colorado Squawfish ..........
Rainbow Trout ...................
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F, M
R, M
S, U
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S, U
F, M
F, M
S, U
F, M
S, U
S, U
S, U
S, U
S, U
S, U
S, M
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S, U
S, U
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pH
7.80
7.87
8.0–8.1
7.9–8.0
7.23
7.9
7.9
7.29
7.9–8.7
7.5–7.6
8.0–8.4
7.5–7.9
7.3–7.7
7.8–8.1
7.5–7.6
6.5–7.9
7.8–7.9
8.25
7.8–7.9
7.9–8.0
8.0–8.2
7.61
7.7–8.1
7.6–7.7
6.72
8.0
8.1–8.2
7.5–7.7
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LC50 or
EC50
(μg/L)
21
104
110
120
128
140
140
140
150
150
160
160
160
160
170
180
180
190
190
190
190
209
210
220
221
230
240
260
Reference
Ref. 4.
Ref. 4.
Ref. 7.
Ref. 7.
Ref. 8.
Ref. 9.
Ref. 9.
Refs. 10 and 11.
Ref. 5.
Ref. 9.
Ref. 12.
Ref. 9.
Ref. 9.
Ref. 9.
Ref. 9.
Ref. 9.
Ref. 9.
Ref. 6.
Ref. 9.
Ref. 9.
Ref. 7.
Ref. 4.
Ref. 9.
Ref. 9.
Ref. 4.
Ref. 7.
Ref. 9.
Ref. 9.
EP20JN13.011
Method a
Species
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TABLE 1—ACUTE TOXICITY OF NONYLPHENOL TO FRESHWATER ORGANISMS—Continued
Method a
Species
Common name
Oncorhynchus mykiss (1.09 ± 0.38g) ...........................
Gila elegans (0.29 ± 0.08g) ...........................................
Ptychocheilus lucius (0.34 ± 0.05g) ..............................
Pimephales promelas (0.39 ± 0.14g) ............................
Pimephales promelas (0.45 ± 0.35g) ............................
Gila elegans (0.52 ± 0.09g) ...........................................
Pimephales promelas (0.40 ± 0.21g) ............................
Lumbriculus variegatus (adult) ......................................
Pimephales promelas (0.56 ± 0.19g) ............................
Ophiogomphus sp. (nymph) ..........................................
Physella virgata (adult) ..................................................
Rainbow Trout ...................
Bonytail Chub ....................
Colorado Squawfish ..........
Fathead Minnow ................
Fathead Minnow ................
Bonytail Chub ....................
Fathead Minnow ................
Annelid ...............................
Fathead Minnow ................
Dragonfly ...........................
Snail ...................................
aS
S, U
S, U
S, U
S, U
S, U
S, U
S, U
F, M
S, U
F, M
F, M
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
pH
7.7–7.9
7.7–7.9
7.8–8.0
7.8–8.2
7.6–7.8
7.4–7.6
7.5–7.9
6.75
7.8–8.1
8.06
7.89
LC50 or
EC50
(μg/L)
270
270
270
290
310
310
330
342
360
596
774
Reference
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
9.
9.
9.
9.
9.
9.
9.
4.
9.
4.
4.
= Static; R = Renewal; F = Flow-through; M = Measured; U = Unmeasured.
2. Saltwater Species. The acute
toxicity values of nonylphenol to
saltwater organisms are shown in Table
2. Acute toxicities have been
determined for 11 species within 11
genera. Acute toxicity values ranged
from 17 mg/L for the winter flounder
(Pleuronectes americanus) (Ref. 13), to
310 mg/L for the sheepshead minnow
(Cyprinodon variegatus) (Ref. 14).
A number of benthic invertebrates
have been investigated including a
deposit-feeding clam (Mulinia lateralis)
with an LC50 of 38 mg/L (Ref. 13), a
copepod (Acartia tonsa) with an LC50 of
190 mg/L (Ref. 15), the American lobster
(Homarus americanus) with an LC50 of
71 mg/L (Ref. 13), the mud crab
(Dyspanopeus sayii) with an LC50
greater than 195 mg/L (Ref. 13), and two
amphipods (Leptocheirus plumulosus)
with an LC50 of 62 mg/L (Ref. 13) and
(Eohaustorius estuarius) with an LC50 of
138 mg/L (Ref. 16).
TABLE 2—ACUTE TOXICITY OF NONYLPHENOL TO SALTWATER AQUATIC ORGANISMS
Method a
Species
Common name
Pleuronectes americanus (48 hrs old) ..........................
Mulinia lateralis (embryo/larvae) ...................................
Mysidopsis bahia b (< 24 hrs old) ..................................
Palaemonetes vulgaris (48 hrs old) ..............................
Americamysis bahia (< 24 hrs old) ...............................
Leptocheirus plumosus (adult) ......................................
Menidia beryllina (juvenile) ............................................
Homarus americanus (1st stage larvae) .......................
Eohaustorius estuarius (adult) ......................................
Cyprinodon variegatus (juvenile) ...................................
Acartia tonsa (10–12 days old) .....................................
Dyspanopeus sayii (4th and 5th stage larvae) .............
Cyprinodon variegatus (juvenile) ...................................
Winter Flounder .................
Coot Clam .........................
Mysid Shrimp .....................
Grass shrimp .....................
Mysid Shrimp .....................
Amphipod ..........................
Inland Silversides ..............
American Lobster ..............
Amphipod ..........................
Sheepshead Minnow .........
Copepod ............................
Mud Crab ...........................
Sheepshead Minnow .........
S, M
S, U
F, M
F, M
F, M
F, M
F, M
R, U
S, U
F, M
S, U
F, M
F, M
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
pH
7.8–8.2
7.8–8.2
7.3–8.2
7.8–8.2
7.8–8.2
7.8–8.2
7.8–8.2
7.8–8.2
missing
7.8–8.2
missing
7.8–8.2
7.4–8.1
LC50 or
EC50
(μg/L)
17
38
43
59
61
62
70
71
138
142
190
> 195
310
Reference
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
Ref.
13.
13.
17.
13.
13.
13.
13.
13.
16.
13.
15.
13.
14.
aS
= Static; R = Renewal; F = Flow-through; M = Measured; U = Unmeasured.
that there has been a taxonomic name change, Mysidopsis bahia is now Americamysis bahia, the original names from the studies are
used in this document to avoid any confusion.
b Note
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B. Chronic Toxicity to Aquatic Animals
1. Freshwater Species. The chronic
toxicity of nonylphenol to freshwater
animals has been studied in two fish
and three invertebrate species (Table 3).
Of the invertebrates, a number of
species of the cladoceran (water fleas)
genus Daphnia have been extensively
tested for chronic effects. Water flea
(Ceriodaphnia dubia) neonates
exhibited reproductive impairment
when exposed to nonylphenol for 7
days at 202 mg/L and survival was
impaired at concentrations of 377 mg/L
(Ref. 18). Four to 24-hour old water fleas
(Daphnia magna) showed a reduction in
the number of young per brood over 9
days of exposure to concentrations as
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low as 48 mg/L. Based on this study, a
chronic Lowest-Observed-EffectConcentration (LOEC) was calculated to
be 23 mg/L for effects on brood
production (Ref. 19). Water fleas
(Daphnia magna) exposed to 71 and 130
mg/L nonylphenol for 21 days exhibited
declines in both growth and adult
survival rates (Ref. 6). In a separate 21day life cycle study of water fleas
(Daphnia magna); growth, reproduction,
and survival were all reduced at
concentrations of 158 mg/L and above
(Ref. 4).
Less than 24-hour-old midge
(Chironomus tentans) larvae exposed to
concentrations of nonylphenol from 12
to 200 mg/L and showed significant
declines in larval survival over the first
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20 days of exposure. The chronic
toxicity value for survival was
calculated as 62 mg/L (Ref. 20).
A 91-day life stage test was conducted
with the embryos and fry of rainbow
trout (Oncorhynchus mykiss) at
concentrations from 6 to 114 mg/L.
Nearly all larvae were abnormal at the
two highest exposure concentrations
(≥ 53 mg/L) (Ref. 4). Survival was
reduced at ≥ 23 mg/L and growth
measured as both change in weight and
length was even more sensitive with
measured decreases at concentrations as
low as 10 mg/L. The chronic toxicity
effect value for growth (both weight and
length) was calculated as 8 mg/L (Ref. 4).
Embryos and larvae of the fathead
minnow (Pimephales promelas) were
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exposed in a 33-day early-life-stage test
at nonylphenol concentrations ranging
from 3 to 23 mg/L (Ref. 21). Hatching
was delayed at the two highest
concentrations (14 and 23 mg/L).
Fathead minnow survival was reduced
at concentrations of 14 mg/L and greater.
The survival chronic toxicity effect
value for fathead minnows was
calculated to be 14 mg/L (Ref. 21).
2. Saltwater Species. Two chronic
toxicity tests have been conducted with
mysid shrimp (Mysidopsis bahia) (Ref.
22). The first experiment was a 28-day
exposure measuring survival, growth,
and reproduction. Shrimp survival was
reduced by 18% on exposure to 9 mg/L.
Growth in length was the most sensitive
endpoint with a 7% reduction in length
for animals exposed to 7 mg/L and NoObserved-Effect-Concentration (NOEC)
and LOEC for growth responses of 4 and
7 mg/L (Table 3).
The second experiment, a 28-day lifecycle test, examined the effect of
nonylphenol on brood release and
growth (Ref. 23). Growth of female
mysids (Americamysis bahia) was
reduced at concentrations at and above
28 mg/L. Brood production was the most
sensitive endpoint in this study. The
average number of young per femalereproductive day was reduced at
concentrations ≥ 15 mg/L. The NOECs
and LOECs for reproductive responses
were 9 and 15 mg/L.
TABLE 3—CHRONIC TOXICITY OF NONYLPHENOL TO AQUATIC ORGANISMS
[Freshwater and Saltwater]
Chronic
value
range
(μg/L)
Species
Common name
Method a b
Mysidopsis bahia c ............
Mysid Shrimp ...................
LC, SW ....
7.4–8.3
5
Oncorhynchus mykiss ......
Rainbow Trout ..................
ESL, FW ..
6.97
8
Mysidopsis bahia c ............
Mysidopsis bahia c ............
Americamysis bahia .........
Mysid Shrimp ...................
Mysid Shrimp ...................
Mysid Shrimp ...................
LC, SW ....
LC, SW ....
LC, SW ....
7.4–8.3
7.4–8.3
Missing
9
9
12
Pimephales promelas .......
Fathead Minnow ..............
ELS, FW ..
7.1–8.2
14
Oncorhynchus mykiss ......
Daphnia magna ................
Rainbow Trout ..................
Water Flea .......................
ESL, FW ..
LC, FW ....
6.97
8.04
23
23
Americamysis bahia .........
Daphnia magna ................
Oncorhynchus mykiss ......
Chironomus tentans .........
Mysid Shrimp ...................
Water Flea .......................
Rainbow Trout ..................
Midge ...............................
LC, SW ....
LC, FW ....
ESL, FW ..
LC, FW ....
Missing
8.25
6.97
7.73
28
39
53
62
Daphnia magna ................
Daphnia magna ................
Daphnia magna ................
Water Flea .......................
Water Flea .......................
Water Flea .......................
LC, FW ....
LC, FW ....
LC, FW ....
8.25
8.25
8.46
71
130
158
Ceriodaphnia dubia ..........
Ceriodaphnia dubia ..........
Water Flea .......................
Water Flea .......................
LC, FW ....
LC, FW ....
8.3–8.6
8.3–8.6
202
377
pH
Endpoint
(NOEC x LOEC)1/2
Growth.
(NOEC x LOEC)1/2
Growth.
Survival ............................
Reproduction ....................
(NOEC x LOEC)1/2 Total
Number of Young.
Delayed Hatching; Survival.
Survival ............................
(NOEC x LOEC)1/2 Total
Number of Young.
Growth ..............................
Number of Live Young .....
Abnormal Development ...
(NOEC x LOEC)1/2 20 d
Survival.
Growth ..............................
Adult Survival ...................
(NOEC x LOEC)1/2
Growth and Reproduction; Survival.
Reproductive Impairment
Survival ............................
Reference
Ref. 22.
Ref. 4.
Ref. 22.
Ref. 22.
Ref. 23.
Ref. 21.
Ref. 4.
Ref. 19.
Ref.
Ref.
Ref.
Ref.
23.
6.
4.
20.
Ref. 6.
Ref. 6.
Ref. 4.
Ref. 18.
Ref. 18.
a LC
= life-cycle or partial life-cycle; ELS = early life-stage.
= Freshwater, SW = Saltwater.
c Note that there has been a taxonomic name change, Mysidopsis bahia is now Americamysis bahia, the original names from the studies are
used in this document to avoid any confusion.
b FW
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C. Toxicity to Aquatic Plants
D. Bioaccumulation
1. Freshwater. Ecological toxicity data
for freshwater plants was available only
for single-celled planktonic green alga
(Selenastrum capricornutum) (Ref. 24).
Algae exposed to nonylphenol for 4
days had an EC50 for effect on
population growth rate of 410 mg/L. The
effect did not persist when the algae
were transferred to fresh,
uncontaminated, growth medium.
2. Saltwater. Ecological toxicity data
for saltwater plants are available only
for a single species of marine planktonic
algae, a diatom (Skeletonema costatum)
(Ref. 25). The EC50 for nonylphenol
effect on vegetative growth was 27
mg/L.
1. Freshwater Species. Data on
bioaccumulation of nonylphenol in
freshwater organisms was limited to two
species of fish, fathead minnow
(Pimephales promelas) and bluegill
(Lepomis macrochirus). Juvenile fathead
minnows exposed to 5 and 23 mg/L
nonylphenol for 27 days showed nonlipid-normalized bioconcentration
factors (BCF) of 271 and 344
respectively (Ref. 26). Values which had
been normalized to organism lipid
content were approximately five times
lower. A short-term (4-day) bioassay
indicated that tissue concentrations
reached steady-state within two days in
both the fathead minnow and bluegill
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(Ref. 27). Overall, lipid-normalized
BCF’s for fathead minnows in 4- and 27day tests ranged from 128 to 209 and for
bluegills from 39 to 57 (Ref. 8). A 42-day
exposure experiment using fathead
minnows and exposure concentrations
of 0.4 to 3.4 mg/L resulted in BCFs
ranging from 203 to 268 (Ref. 28).
2. Saltwater Species. Bioconcentration
factors are available for three species of
marine animals; the blue mussel
(Mytilus edulis), the three-spined
stickleback fish (Gasterosteus
aculeatus), and a benthic shrimp
(Crangon crangon) (Ref. 29). Individuals
of all three species were exposed to
carbon-14 (14C)-labeled nonylphenol for
16 days and followed over a subsequent
elimination period of 32 days. BCFs
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ranged from a measured value in
benthic shrimp of 79 to an estimated
value of 2,168 for the blue mussel.
E. Reproductive, Developmental, and
Estrogenic Effects
Numerous investigations have
demonstrated the estrogenic activity of
nonylphenol (see Refs. 30, 31, and 32
for reviews). The majority of studies
have been conducted with aquatic
species and effects have been
demonstrated both in vitro and in vivo.
While most of these studies have been
conducted on fish, a number of species
of invertebrates have also been
examined.
1. Aquatic Invertebrates. Among
invertebrates, estrogenic effects have
been demonstrated in a marine
amphipod (Corophium volutator) at 10
mg/L (Ref. 33) and larvae of a freshwater
insect (Chironomus riparis) at 2,000 mg/
L (Ref. 34). However, no estrogenic
effects were found in a marine copepod
(Tisbe battagliai) at exposure
concentrations up to 55 mg/L (Ref. 35).
2. In Vivo Responses in Fish. The
protein vitellogenin, which is produced
in the liver, is a primary constituent in
the yolk of the ova of oviparous
vertebrate species (i.e., species
producing eggs which hatch outside the
body). Very little vitellogenin is
produced in males and increased
vitellogenin production in males is an
indication of estrogenic effects. While
nonylphenol has been shown to
produce estrogenic effects, estimates
from studies on male rainbow trout
(Oncorhynchus mykiss) suggest that it is
2,000 to 3,000 times less potent than
natural estrogen (17 beta-estradiol) (Ref.
36).
Exposure to nonylphenol has been
shown to increase vitellogenin
production in male rainbow trout
(Oncorhynchus mykiss) at
concentrations from 10 to 100 mg/L over
periods of 4 hours to 3 days (Refs. 37,
38 and 39). Jobling and colleagues (Ref.
40) also found increased vitellogenin
production in male rainbow trout after
21 days of exposure to nonylphenol
concentrations of 20 and 54 mg/L.
Similarly, Tremblay and van der Kraak
(Ref. 41) found increased plasma
vitellogenin after 3 weeks of exposure to
50 mg/L nonylphenol in rainbow trout.
Female rainbow trout are similarly
sensitive with vitellogenin induction
occurring with exposures ranging from
8 to 86 mg/L (Ref. 42). The study on
female rainbow trout also noted that
nonylphenol exposure caused changes
in several pituitary and hormone plasma
levels. Exposure to nonylphenol
concentrations as low as 4 mg/L led to
vitellogenin induction in male green
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swordfish (Xiphophorous helleri). In
contrast, additional studies did not
show vitellogenin induction in rainbow
trout exposed for 9 days at 109 mg/L
(Ref. 43) or the Atlantic salmon (Salmo
trutta) exposed for 30 days to 20 mg/L
(Ref. 44).
Vitellogenin messenger ribonucleic
acid (mRNA) is a direct precursor to
protein formation and increased
production in rainbow trout at
concentrations of 10 to 14 mg/L when
exposed for 4 and 72 hours respectively
(Ref. 3). Increased levels of plasma
vitellogenin and several pituitary and
plasma hormone levels were observed
in female rainbow trout exposed to 8
and 86 mg/L nonylphenol. The route of
exposure influenced vitellogenin
induction in the fathead minnow with
an order of magnitude greater induction
when exposed via water as opposed to
diet (Ref. 45).
Fish fecundity (i.e., the rate of
production of young) is also affected in
various ways by nonylphenol exposure
(Ref. 28). Concentrations as low as 0.5
to 3.4 mg/L, although not acutely toxic,
decreased the fecundity of fathead
minnows at various times over the
reproductive season. At concentrations
of approximately 0.1 mg/L, fecundity
was increased in fathead minnows.
These results suggest a possible
hormetic response of fish fecundity to
nonylphenol.
A number of studies have been
performed with the fish Japanese
medaka (Oryzias latipes). Following
hatch, a cohort of Japanese medaka was
exposed for 28 days and monitored for
the following 55 days for survival,
growth, egg viability, egg production,
and gonosomatic index (GSI) (Ref. 46).
No effects were noted at the lowest
exposure concentration of 1.93 mg/L.
However, in a 3-month exposure study
with the same species, effects were
noted at 50 mg/L and included intersex
(development of ovo-testis) and the sex
ratio shifted in favor of females (Ref.
47). Another study of Japanese medaka
found that, in fish exposed from
fertilized egg to 60 days post-hatch, the
LOEC for vitellogenin induction was
found to be 12 mg/L (Ref. 48).
A two-generation (F0 and F1) flowthrough study exposed Japanese medaka
from eggs to 60 days post-hatch of the
second (F1) generation at concentrations
ranging from 4 to 183 mg/L (Ref. 49). For
the F0 generation, egg hatchability was
reduced by 48% at 187 mg/L. Survival
was reduced at 60 days post-hatch for
exposures at or above 18 mg/L. However,
no differences in growth rates were
observed in the F0 generation at any
exposure concentration 60 days posthatch. Induction of ovo-testis was
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Sfmt 4702
observed at 18 mg/L with 20% of the fish
exhibiting external male characteristics
having ovo-testis. At 51 mg/L, all fish
exhibited external female characteristics
with 40% containing ovo-testis.
Spermatogenesis was observed in ovotestis containing fish exposed to 18 but
not 51 mg/L. Fecundity was not affected
by nonylphenol exposure. GSI of female
fish was increased by exposure to
concentrations greater than 8 mg/L.
Effects of exposure on the F1
generation were also reported with no
embryological abnormalities or hatching
failures observed at any of the treatment
concentrations. Growth was also not
affected at 60 days post-hatch in the F1
generation. However, the sex ratio as
determined by secondary sexual
characteristics changed in favor of
females (1:2) at concentrations greater
than 18 mg/L. Induction of ovo-testis
occurred at lower concentrations in the
F1 as opposed to the F0 generation (8
versus 18 mg/L). All fish in the F1
generation with ovo-testis displayed
external male characteristics and the
degree of oocyte development was not
as complete as with the F0 18 mg/L
treatment. The overall results suggest a
NOEC and LOEC of approximately 8
and 18 mg/L respectively.
A multi-generational study has also
been conducted for the rainbow trout
(Oncorhynchus mykiss) (Ref. 50).
Exposure to concentrations of 1 and 10
mg/L of adult males and females was
intermittent over 4 months. Vitellogenin
induction was increased in adult male
fish exposed to both 1 and 10 mg/L. Male
progeny of fish exposed to 10 mg/L
showed elevated plasma estradiol
concentrations. Female progeny showed
elevated levels of plasma testosterone
and vitellogenin concentrations.
V. Rationale for Listing
EPA’s technical evaluation of
nonylphenol shows that it can
reasonably be anticipated to cause,
because of its toxicity, significant
adverse effects in aquatic organisms.
Toxicity values for nonylphenol are
available for numerous species of
aquatic organisms. The observed effects
from nonylphenol exposure occur at
very low concentrations demonstrating
that nonylphenol is highly toxic to
aquatic organisms. Data summarized in
this document include acute toxicity
values for freshwater organisms ranging
from 21 mg/L for a detritivorous
amphipod to 774 mg/L for an algal
grazing snail. Acute toxicity values for
freshwater fish ranged from 110 mg/L for
the fountain darter to 128 to 360 mg/L
for the fathead minnow. Acute toxicity
values for saltwater organisms ranged
from 17 mg/L for the winter flounder to
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310 mg/L for the sheepshead minnow.
Chronic toxicity values are also
available for several aquatic species
ranging from 5 mg/L for growth effects in
mysid shrimp to 377 mg/L for survival
effects in water fleas. Chronic toxicity
values for rainbow trout ranged from 8
mg/L for effects on growth to 53 mg/L for
abnormal development. Reproductive,
developmental, and estrogenic effects
on aquatic organisms have also been
reported for nonylphenol with some
effects observed at concentrations of 4
mg/L or less. Therefore, EPA believes
that the evidence is sufficient for listing
the nonylphenol category on the EPCRA
section 313 toxic chemical list pursuant
to EPCRA section 313(d)(2)(C) based on
the available ecological toxicity data.
EPA does not believe that it is
appropriate to consider exposure for
chemicals that are highly toxic based on
a hazard assessment when determining
if a chemical can be added for
environmental effects pursuant to
EPCRA section 313(d)(2)(C) (see 59 FR
61440–61442). Therefore, in accordance
with EPA’s standard policy on the use
of exposure assessments (59 FR 61432),
EPA does not believe that an exposure
assessment is necessary or appropriate
for determining whether the
nonylphenol category meets the criteria
of EPCRA section 313(d)(2)(C).
VI. References
EPA has established an official public
docket for this action under Docket ID
No. EPA–HQ–TRI–2012–0110. The
public docket includes information
considered by EPA in developing this
action, including the documents listed
below, which are electronically or
physically located in the docket. In
addition, interested parties should
consult documents that are referenced
in the documents that EPA has placed
in the docket, regardless of whether
these referenced documents are
electronically or physically located in
the docket. For assistance in locating
documents that are referenced in
documents that EPA has placed in the
docket, but that are not electronically or
physically located in the docket, please
consult the person listed in the above
FOR FURTHER INFORMATION CONTACT
mstockstill on DSK4VPTVN1PROD with PROPOSALS
section.
1. USEPA. 2010. Nonylphenol (NP) and
Nonylphenol Ethoxylates (NPEs) Action
Plan (RIN 2070–ZA09). United States
Environmental Protection Agency,
Washington, DC. August 18, 2010.
2. Lorenc, J. F., Lambeth, G. and Scheffer, W.
2003. Alkylphenols. Kirk-Othmer
Encyclopedia of Chemical Technology,
John Wiley & Sons, Inc. 2:225.
3. USEPA. 2005. Aquatic Life Ambient Water
Quality Criteria—Nonylphenol Final.
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United States Environmental Protection
Agency, Washington, DC. Office of
Water. EPA–822–R–05–005. December
2005.
4. Brooke, L.T. 1993a. Acute and chronic
toxicity of nonylphenol to ten species of
aquatic organisms. Report to the U.S.
EPA for Work Assignment No. 02 of
Contract No. 68–C1–0034. Lake Superior
Research Institute, University of
Wisconsin-Superior, Superior, WI.
March 24. 30 pp. Amended 18 October
2005. 34 pp.
5. England, D.E. and J.B. Bussard. 1995.
Toxicity of nonylphenol to the
amphipod Hyalella azteca (Saussure).
Report No. 41569. ABC Laboratories,
Inc., Columbia, MO. 178 pp.
6. Comber, M.H.I., T.D. Williams and K.M.
Stewart. 1993. The effects of
nonylphenol on Daphnia magna. Wat.
Res. 27: 273–276.
7. Dwyer, F.J., D.K. Hardesty, C.E. Henke,
C.G. Ingersoll, D.W. Whites, D.R. Mount
and C.M. Bridges. 1999. Assessing
contaminant sensitivity of endangered
and threatened species: Toxicant classes.
EPA/600/R–99/098. National Technical
Information Service, Springfield, VA.
15pp.
8. Brooke, L.T. 1993b. Nonylphenol Toxicity.
Accumulation and lethality for two
freshwater fishes (fathead minnow and
bluegill) to nonylphenol. Report to the
U.S. EPA for the Work Assignment No.
1–12 of Contract No. 68–C1–0034. Lake
Superior Research Institute, University
of Wisconsin-Superior, WI. September
30. 50 pp.
9. Dwyer, F.J., L.C. Sappington, D.R. Buckler
and S.B. Jones. 1995. Use of surrogate
species in assessing contaminant risk to
endangered and threatened fishes. EPA/
600/R–96/029. National Technical
Information Service, Springfield, VA. 71
pp.
10. Holcombe, G.W., G.L. Phipps, M.L. Knuth
and T. Felhaber. 1984. The acute toxicity
of selected substituted phenols,
benzenes, and benzoic acid esters to
fathead minnows (Pimephales
promelas). Environ. Pollut. (Series A) 35:
367–381.
11. University of Wisconsin-Superior. 1985.
Acute toxicities of organic chemicals to
fathead minnows (Pimephales
promelas). Volume II. D.L. Geiger, C.E.
Northcott, D.J. Call, and L.T. Brooke
(Eds.). Center for Lake Superior
Environmental Studies, University of
Wisconsin-Superior, Superior, WI. 326
pp.
12. England, D.E. and J.B. Bussard. 1993.
Toxicity of nonylphenol to the midge
Chironomus tentans. Report No. 40597.
ABC Laboratories, Inc., Columbia, MO.
92 pp.
13. Lussier, S.M., D. Champlin, J. LiVolsi, S.
Poucher and R.J. Pruell. 2000. Acute
toxicity of para-nonylphenol to saltwater
animals. Environ. Toxicol. Chem. 19:
617–621.
14. Ward, T.J. and R.L. Boeri. 1990a. Acute
flow through toxicity of nonylphenol to
the sheepshead minnow, Cyprinodon
variegatus. EnviroSystems Study
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pp.
15. Kusk, K.O. and L. Wollenberger. 1999.
Fully defined saltwater medium for
cultivation of and toxicity testing with
the marine copepod Acartia tonsa.
Environ. Toxicol. Chem. 20: 1564–1567.
16. Hecht, S. and B.L. Boese. 2002.
Sensitivity of an infaunal amphipod,
Eohaustorius estuaries, to acute
waterborne exposures of 4-nonylphenol:
Evidence of a toxic hangover. Environ.
Toxicol. Chem. 21: 816–819.
17. Ward, T.J. and R.L. Boeri. 1990b. Acute
flow through toxicity of nonylphenol to
the mysid, Mysidopsis bahia.
EnviroSystems Study Number 8974–
CMA, Hampton, NH. 35 pp.
18. England, D.E. 1995. Chronic toxicity of
nonylphenol to Ceriodaphnia dubia.
Report No. 41756. ABC Laboratories, Inc.
Columbia, MO. 409 pp.
19. Fliedner, A. 1993. Daphnia magna
Reproduction test (OECD) No. 202).
Fraunhofer-Institute fur Umweltchemie
und Okotoxikologie, Posfach 1260, W–
5948 Schmallenberg—Grafschaft,
Germany. Report No. UBA–002/4–22
February.
20. Kahl, M.D., E.A. Makynen, P.A. Kosian
and G.T. Ankley. 1997. Toxicity of 4nonylphenol in a life-cycle test with the
midge Chironomus tentans. Ecotoxicol.
Environ. Saf. 38: 155–160.
21. Ward, T.J. and R.L. Boeri. 1991a. Early
life stage toxicity of nonylphenol to the
fathead minnow, Pimephales promelas.
EnviroSystems Study Number 8979–
CMA, Hampton, NH. 59 pp.
22. Ward, T.J. and R.L. Boeri. 1991b. Chronic
toxicity of nonylphenol to the mysid,
Mysidopsis bahia. EnviroSystems Study
Number 8977–CMA, Hampton, NH. 61
pp.
23. Kuhn, A., W.R. Munns, Jr., D. Champlin,
R. McKinney, M. Tagliabue, J. Serbst and
T. Gleason. 2001. Evaluation of the
efficacy of extrapolation population
modeling to predict the dynamics of
Americamysis bahia populations in the
laboratory. Environ. Toxicol. Chem. 20:
213–221.
24. Ward, T.J. and R.L. Boeri. 1990c. Acute
static toxicity of nonylphenol to the
freshwater alga Selenastrum
capricornutum. EnviroSystems Study
Number 8969–CMA, Hampton, NH. 41
pp.
25. Ward, T.J. and R.L. Boeri. 1990d. Acute
static toxicity of nonylphenol to the
marine alga Skeletonema costatum.
EnviroSystems Study Number 8970–
CMA, Hampton, NH. 42 pp.
26. Ward, T.J. and R.L. Boeri. 1991c.
Bioconcentration test with nonlylphenol
and the Fathead Minnow, Pimephales
promelas. EnviroSystems Study Number
8975–CMA, Hampton, NH. 72 pp.
27. Brooke, L.T. 1994. Nonylphenol Analysis.
Accumulation and lethality for two
freshwater fishes (fathead minnow and
bluegill) to nonylphenol. Report to the
U.S. EPA for the Work Assignment No.
2–15 of Contract No. 68–C1–0034. Lake
Superior Research Institute, University
of Wisconsin-Superior, WI. May 31. 49
pp.
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28. Giesy, J.P., S.L. Pierens, E.M. Snyder, S.
Miles-Richardson, V.J. Kramer, S.A.
Snyder, K.M. Nichols, and D.A.
Villeneuve. 2000. Effects of 4nonylphenol on fecundity of biomarkers
of estrogenicity in fathead minnows
(Pimephales promelas). Environ.
Toxicol. Chem. 19: 1368–1377.
29. Ekelund, R., A. Bergman, A. Granmo, and
M. Berggren. 1990. Bioaccumulation of
4-nonylphenol in marine animals—A reevaluation. Environ. Poll. 64: 107–120.
30. Servos, M.R. 1999. Review of the aquatic
toxicity, estrogenic responses, and
bioaccumulation of alkylphenols and
alkylphenol polyethoxylates. Wat. Qual.
Res. J. Can. 34: 123–177.
31. Sonnenschein, C. and A.M. Soto. 1998.
An updated review of environmental
estrogen and androgen mimics and
antagonists. J. Steroid Biochem. Molec.
Biol. 65: 143–150.
32. Sumpter, J.P. 1998. Xenoendocrine
disrupters—environmental impacts.
Toxicol. Lett. 102–103: 337–342.
33. Brown, R.J., M. Conradi, and M.H.
Depledge. 1999. Long-term exposure to
4-nonylphenol affects sexual
differentiation and growth of the
amphipod Corophium volutator (Pallus,
1766). Sci. Total Environ. 233: 77–88.
34. Hahn, T., K. Schenk, and R. Schulz. 2002.
Environmental chemicals with known
endocrine potential affect yolk protein
content in the aquatic insect Chironomus
riparius. Environ. Pollut. 120: 525–528.
35. Bechmann, R.K. 1999. Effect of the
endocrine disruptor nonylphenol on the
marine copepod Tisbe battagliai. Sci.
Total Environ. 233: 33–46.
36. Islinger, M., S. Pawlowski, H. Hollert, A.
Volkl, and T. Braumbeck. 1999.
Measurement of vitellogenin-mRNA
expression in primary cultures of
rainbow trout hepatocytes in a nonradioactive dot blot/RNAse protectionassay. Sci. Total Environ. 233:109–122.
37. Ren, L., D. Lattier, and J.J. Lech. 1996a.
Estrogenic activity in rainbow trout
determined with a new cDNA probe for
vitellogenesis, pSG5Vg1.1. Bull. Environ.
Contam. Toxicol. 56: 287–294.
38. Ren, L., S.K. Lewis, and J.J. Lech. 1996b.
Effects of estrogen and nonylphenol on
the post-transcriptional regulation of
vitellogenin gene expression. ChemicoBiol. Interact. 100: 67–76.
39. Lech, J.J., S.K. Lewis, and L. Ren. 1996.
In vivo estrogenic activity of
nonylphenol in rainbow trout. Fund.
Appl. Toxicol. 30: 229–232.
40. Jobling, S., D. Sheahan, J.A. Osborne, P.
Matthiessen, and J.P. Sumpter. 1996.
Inhibition of testicular growth in
rainbow trout (Oncorhynchus mykiss)
exposed to estrogenic alkylphenolic
chemicals. Environ. Toxicol. Chem. 15:
194–202.
41. Tremblay, L. and G. van der Kraak. 1998.
Use of a series of homologous in vitro
and in vivo assays to evaluate the
endocrine modulating actions of betasitosterol in rainbow trout. Aquat.
Toxicol. 43: 149–162.
42. Harris, C.A., E.M. Santos, a. Janbakhsh,
T.G. Pottinger, C.R. Tyler, and J.P.
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Sumpter. 2001. Nonylphenol affects
gonadotropin levels in the pituitary
gland and plasma of female rainbow
trout. Environ. Sci. Technol. 35: 2909–
2916.
43. Pedersen, S.N. L.B. Christiansen, K.L.
Pedersen, B. Korsgaard, and P.
Bjerregaard. 1999. In vivo estrogenic
activity of branched and linear
alkylphenols in rainbow trout
(Oncorhychus mykiss). Sci. Tot. Environ.
233: 89–96.
44. Moore, A., A.P. Scott, N. Lower, I.
Katsiadaki, and L. Greenwood. 2003. The
effects of 4-nonylphenol and atrazine on
Atlantic salmon (Salmo salar L.) smolts.
Aquaculture 222: 253–263.
45. Pickford, K.A., R.E. Thomas-Jones, B.
Wheals, C.R. Tyler, and J.P. Sumpter.
2003. Route of exposure affects the
oestrogenic response of fish to 4-tertnonylphenol. Aquat. Toxicol. 65: 267–
279.
46. Nimrod, A.C. and W.H. Benson. 1998.
Reproduction and development of
Japanese medaka following an early life
stage exposure to xenoestrogens. Aquat.
Toxicol. 44: 141–156.
47. Gray, M.A. and C.D. Metcalfe. 1997.
Induction of testis-ova in Japanese
medaka (Oryzias latipes) exposed to pnonylphenol. Environ. Toxicol. Chem.
16: 1082–1086.
48. Seki, M., H. Yokota, M. Maeda, H.
Tadokoro, and K. Kobayashi. 2003.
Effects of 4-nonylphenol and 4-tertoctylphenol on sex differentiation and
vitellogenin induction in medaka
(Oryzias latipes). Environ. Toxicol.
Chem. 22: 1507–1516.
49. Yokota, H., M. Seki, M. Maeda, Y.
Oshima, H. Tadokoro, T. Honjo, and K.
Kobayashi. 2001. Life-cycle toxicity of 4nonylphenol to medaka (Oryzias latipes).
Environ. Toxicol. Chem. 20: 2552–2560.
50. Schwaiger, J., U. Mallow, H. Ferling, S.
Knoerr, T. Braunbeck, W. Kalbfus, and
R.D. Negele. 2000. How estrogenic is
nonylphenol? A transgenerational study
using rainbow trout (Oncorhynchus
mykiss) as a test organism. Aquat.
Toxicol. 59: 177–189.
51. USEPA, OEI. Economic Analysis of the
Proposed Rule to add Nonylphenol to
the EPCRA Section 313 List of Toxic
Chemicals. June 11, 2013.
VII. What are the Statutory and
Executive Order Reviews associated
with this action?
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is not a ‘‘significant
regulatory action’’ under the terms of
Executive Order 12866 (58 FR 51735,
October 4, 1993) and is therefore not
subject to review under Executive
Orders 12866 and 13563 (76 FR 3821,
January 21, 2011).
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B. Paperwork Reduction Act
This proposed rule does not contain
any new information collection
requirements that require additional
approval by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et.
seq. Currently, the facilities subject to
the reporting requirements under
EPCRA 313 and PPA 6607 may use
either the EPA Toxic Chemicals Release
Inventory Form R (EPA Form 9350–1),
or the EPA Toxic Chemicals Release
Inventory Form A (EPA Form 9350–2).
The Form R must be completed if a
facility manufactures, processes, or
otherwise uses any listed chemical
above threshold quantities and meets
certain other criteria. For the Form A,
EPA established an alternative threshold
for facilities with low annual reportable
amounts of a listed toxic chemical. A
facility that meets the appropriate
reporting thresholds, but estimates that
the total annual reportable amount of
the chemical does not exceed 500
pounds per year, can take advantage of
an alternative manufacture, process, or
otherwise use threshold of 1 million
pounds per year of the chemical,
provided that certain conditions are
met, and submit the Form A instead of
the Form R. In addition, respondents
may designate the specific chemical
identity of a substance as a trade secret
pursuant to EPCRA section 322 42
U.S.C. 11042: 40 CFR part 350.
OMB has approved the reporting and
recordkeeping requirements related to
Forms A and R, supplier notification,
and petitions under OMB Control
number 2025–0009 (EPA Information
Collection Request (ICR) No. 1363) and
those related to trade secret designations
under OMB Control 2050–0078 (EPA
ICR No. 1428). As provided in 5 CFR
1320.5(b) and 1320.6(a), an Agency may
not conduct or sponsor, and a person is
not required to respond to, a collection
of information unless it displays a
currently valid OMB control number.
The OMB control numbers relevant to
EPA’s regulations are listed in 40 CFR
part 9, 48 CFR chapter 15, and
displayed on the information collection
instruments (e.g., forms, instructions).
For the 57 Form Rs and 13 Form As
expected to be filed, EPA estimates the
industry reporting and recordkeeping
burden for collecting this information to
average, in the first year, $246,429
(based on 4,874 total burden hours) (Ref.
51). In subsequent years, the burden for
collecting this information is estimated
to average $117,350 (based on 2,321
total burden hours). These estimates
include the time needed to become
familiar with the requirement (first-year
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only); review instructions; search
existing data sources; gather and
maintain the data needed; complete and
review the collection information; and
transmit or otherwise disclose the
information. The actual burden on any
facility may be different from this
estimate depending on the complexity
of the facility’s operations and the
profile of the releases at the facility.
Upon promulgation of a final rule, the
Agency may determine that the existing
burden estimates in the ICRs need to be
amended in order to account for an
increase in burden associated with the
final action. If so, the Agency will
submit an information collection
worksheet (ICW) to OMB requesting that
the total burden in each ICR be
amended, as appropriate.
C. Regulatory Flexibility Act (RFA), as
Amended by the Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA), 5 U.S.C. 601 et seq.
The RFA generally requires an agency
to prepare a regulatory flexibility
analysis of any rule subject to notice
and comment rulemaking requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions. For
purposes of assessing the impacts of
today’s rule on small entities, small
entity is defined as: (1) A business that
is classified as a ‘‘small business’’ by the
Small Business Administration at 13
CFR 121.201; (2) a small governmental
jurisdiction that is a government of a
city, county, town, school district or
special district with a population of less
than 50,000; and (3) a small
organization that is any not-for-profit
enterprise which is independently
owned and operated and is not
dominant in its field.
After considering the economic
impacts of today’s rule on small entities,
I certify that this action will not have a
significant economic impact on a
substantial number of small entities. Of
the 70 entities estimated to be impacted
by this proposed rule, 34 are small
businesses. Of the affected small
businesses, all 34 are projected to have
cost-to-revenue impacts of less than 1%
in both the first and subsequent years of
the rulemaking. Facilities eligible to use
Form A (those meeting the appropriate
activity threshold which have 500
pounds per year or less of reportable
amounts of the chemical) will have a
lower burden. No small governments or
small organizations are expected to be
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affected by this action. Thus this rule is
not expected to have a significant
adverse economic impact on a
substantial number of small entities. A
more detailed analysis of the impacts on
small entities is located in EPA’s
economic analysis support document
(Ref. 51). We continue to be interested
in the potential impacts of the proposed
rule on small entities and welcome
comments on issues related to such
impacts.
D. Unfunded Mandates Reform Act
This rule does not contain a Federal
mandate that may result in expenditures
of $100 million or more for State, local,
and tribal governments, in the aggregate,
or the private sector in any one year.
EPA’s economic analysis indicates that
the total cost of this rule is estimated to
be $246,722 in the first year of
reporting. Thus, this rule is not subject
to the requirements of sections 202 or
205 of UMRA.
This rule is also not subject to the
requirements of section 203 of UMRA
because it contains no regulatory
requirements that might significantly or
uniquely affect small governments.
Small governments are not subject to the
EPCRA section 313 reporting
requirements.
37185
13175, and consistent with EPA policy
to promote communications between
EPA and Indian Tribal Governments,
EPA specifically solicits additional
comment on this proposed action from
tribal officials.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets EO 13045 (62 FR
19885, April 23, 1997) as applying only
to those regulatory actions that concern
health or safety risks, such that the
analysis required under section 5–501 of
the EO has the potential to influence the
regulation. This action is not subject to
EO 13045 because it does not establish
an environmental standard intended to
mitigate health or safety risks.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355 (May 22,
2001)), because it is not a significant
regulatory action under Executive Order
12866.
E. Executive Order 13132 (Federalism)
This action does not have federalism
implications. It will not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. This action
relates to toxic chemical reporting under
EPCRA section 313, which primarily
affects private sector facilities. Thus,
Executive Order 13132 does not apply
to this action.
In the spirit of Executive Order 13132,
and consistent with EPA policy to
promote communications between EPA
and State and local governments, EPA
specifically solicits comment on this
proposed action from State and local
officials.
I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law
104–113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards.
This proposed rulemaking does not
involve technical standards. Therefore,
EPA is not considering the use of any
voluntary consensus standards.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications, as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000). This action relates to toxic
chemical reporting under EPCRA
section 313, which primarily affects
private sector facilities. Thus, Executive
Order 13175 does not apply to this
action. In the spirit of Executive Order
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order (EO) 12898 (59 FR
7629 (Feb. 16, 1994)) establishes Federal
executive policy on environmental
justice. Its main provision directs
Federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
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populations) with access to data which
they may use to seek lower exposures
and consequently reductions in
chemical risks for themselves and their
children. This information can also be
used by government agencies and others
to identify potential problems, set
priorities, and take appropriate steps to
reduce any potential risks to human
health and the environment. Therefore,
the informational benefits of the
proposed rule will have a positive
impact on the human health and
environmental impacts of minority
populations, low-income populations,
and children.
List of Subjects in 40 CFR Part 372
Environmental protection,
Community right-to-know, Reporting
and recordkeeping requirements, and
Toxic chemicals.
Fisheries Service (NMFS) periodically
review existing regulations that have a
significant economic impact on a
substantial number of small entities,
such as small businesses, small
DEPARTMENT OF COMMERCE
organizations, and small governmental
National Oceanic and Atmospheric
jurisdictions. This plan describes how
Administration
NMFS will perform this review and
describes the regulations that are being
50 CFR Chapters II, III, IV, V, and VI
proposed for review during the current
review-cycle.
RIN 0648–XC637
DATES: Written comments must be
Plan for Periodic Review of
received by NMFS by July 22, 2013.
Regulations
ADDRESSES: You may submit comments
on this document, identified by NOAA–
AGENCY: National Marine Fisheries
NMFS–2012–0160, by any of the
Service (NMFS), National Oceanic and
following methods:
Atmospheric Administration (NOAA),
• Electronic Submission: Submit all
Commerce.
electronic public comments via the
ACTION: Proposed rule; request for
Federal e-Rulemaking Portal. Go to
comments.
www.regulations.gov/
SUMMARY: The Regulatory Flexibility Act #!docketDetail;D=NOAA-NMFS-2012(RFA) requires that the National Marine 0160, click the ‘‘Comment Now!’’ icon,
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Dated: June 14, 2013.
Bob Perciasepe,
Acting Administrator.
Therefore, it is proposed that 40 CFR
part 372 be amended as follows:
PART 372—TOXIC CHEMICAL
RELEASE REPORTING: COMMUNITY
RIGHT–TO–KNOW
1. The authority citation for part 372
continues to read as follows:
■
Authority: 42 U.S.C. 11023 and 11048.
2. The table in § 372.65 paragraph (c)
is amended by adding an entry in
alphabetical order for ‘‘Nonylphenol’’ to
read as follows:
■
§ 372.65 Chemicals and chemical
categories to which the part applies.
*
*
*
(c) * * *
*
*
complete the required fields, and enter
or attach your comments.
• Mail: Submit written comments to
Wendy Morrison, National Marine
Fisheries Service, NOAA, Office of
Sustainable Fisheries, 1315 East-West
Highway, Silver Spring, MD 20910
(mark outside of envelope ‘‘Comments
on 610 review’’).
• Fax: 301–713–1193; Attn: Wendy
Morrison.
Instructions: Comments must be
submitted by one of the above methods
to ensure that the comments are
received, documented, and considered
by NMFS. Comments sent by any other
method, to any other address or
individual, or received after the end of
the comment period, may not be
considered. All comments received are
a part of the public record and will
generally be posted for public viewing
on www.regulations.gov without change.
All personal identifying information
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as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States. EPA
has determined that this proposed rule
will not have disproportionately high
and adverse human health or
environmental effects on minority or
low-income populations because it does
not affect the level of protection
provided to human health or the
environment. This proposed rule adds
an additional chemical to the EPCRA
section 313 reporting requirements. By
adding a chemical to the list of toxic
chemicals subject to reporting under
section 313 of EPCRA, EPA would be
providing communities across the
United States (including minority
populations and low income
Agencies
[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Proposed Rules]
[Pages 37176-37186]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14754]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[EPA-HQ-TRI-2012-0110; FRL-9819-1]
RIN 2025-AA34
Addition of Nonylphenol Category; Community Right-to-Know Toxic
Chemical Release Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to add a nonylphenol category to the list of
toxic chemicals subject to reporting under section 313 of the Emergency
Planning and Community Right-to-Know Act (EPCRA) of 1986 and section
6607 of the Pollution Prevention Act (PPA) of 1990. EPA is proposing to
add this chemical category to the EPCRA section 313 list pursuant to
its authority to add chemicals and chemical categories because EPA
believes this category meets the EPCRA section 313(d)(2)(C)
[[Page 37177]]
toxicity criterion. Based on a review of the available production and
use information, the members of the nonylphenol category are expected
to be manufactured, processed, or otherwise used in quantities that
would exceed the EPCRA section 313 reporting thresholds.
DATES: Comments must be received on or before August 19, 2013.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
TRI-2012-0110, by one of the following methods:
www.regulations.gov: Follow the on-line instructions for
submitting comments.
Email: oei.docket@epa.gov.
Mail: Office of Environmental Information (OEI) Docket,
Environmental Protection Agency, Mail Code: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460
Hand Delivery: EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave. NW., Washington, DC 20460. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-TRI-
2012-0110. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, avoid any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., 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 either electronically
in www.regulations.gov or in hard copy at the OEI Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. This
Docket Facility 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 OEI
Docket is (202) 566-1752.
FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Environmental
Analysis Division, Office of Information Analysis and Access (2842T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number: 202-566-0743; fax number: 202-
566-0677; email: bushman.daniel@epa.gov, for specific information on
this notice. For general information on EPCRA section 313, contact the
Emergency Planning and Community Right-to-Know Hotline, toll free at
(800) 424-9346 (select menu option 3) or (703) 412-9810 in Virginia and
Alaska or toll free, TDD (800) 553-7672, https://www.epa.gov/superfund/contacts/infocenter/.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this notice apply to me?
You may be potentially affected by this action if you manufacture,
process, or otherwise use nonylphenol. Potentially affected categories
and entities may include, but are not limited to:
----------------------------------------------------------------------------------------------------------------
Category Examples of potentially affected entities
----------------------------------------------------------------------------------------------------------------
Industry............................................ Facilities included in the following NAICS manufacturing
codes (corresponding to SIC codes 20 through 39): 311*,
312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*,
326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*,
111998*, 211112*, 212324*, 212325*, 212393*, 212399*,
488390*, 511110, 511120, 511130, 511140*, 511191, 511199,
512220, 512230*, 519130*, 541712*, or 811490*.
*Exceptions and/or limitations exist for these NAICS
codes. Facilities included in the following NAICS codes
(corresponding to SIC codes other than SIC codes 20
through 39): 212111, 212112, 212113 (correspond to SIC
12, Coal Mining (except 1241)); or 212221, 212222,
212231, 212234, 212299 (correspond to SIC 10, Metal
Mining (except 1011, 1081, and 1094)); or 221111, 221112,
221113, 221119, 221121, 221122, 221330 (Limited to
facilities that combust coal and/or oil for the purpose
of generating power for distribution in commerce)
(correspond to SIC 4911, 4931, and 4939, Electric
Utilities); or 424690, 425110, 425120 (Limited to
facilities previously classified in SIC 5169, Chemicals
and Allied Products, Not Elsewhere Classified); or 424710
(corresponds to SIC 5171, Petroleum Bulk Terminals and
Plants); or 562112 (Limited to facilities primarily
engaged in solvent recovery services on a contract or fee
basis (previously classified under SIC 7389, Business
Services, NEC)); or 562211, 562212, 562213, 562219,
562920 (Limited to facilities regulated under the
Resource Conservation and Recovery Act, subtitle C, 42
U.S.C. 6921 et seq.) (correspond to SIC 4953, Refuse
Systems).
Federal Government.................................. Federal facilities.
----------------------------------------------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. Some of the entities listed in the table have exemptions and/or
limitations regarding coverage, and other types of entities not listed
in the table could also be affected. To determine whether your facility
would be affected by this action, you should carefully examine the
applicability criteria in part 372 subpart B of Title 40 of the Code of
Federal Regulations. If you have questions regarding the applicability
of this action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.
B. How should I submit CBI to the Agency?
Do not submit CBI information to EPA through www.regulations.gov or
email. Clearly mark the part or all of the
[[Page 37178]]
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
II. Introduction
Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities
that manufacture, process, or otherwise use listed toxic chemicals in
amounts above reporting threshold levels to report their environmental
releases and other waste management quantities of such chemicals
annually. These facilities must also report pollution prevention and
recycling data for such chemicals, pursuant to section 6607 of the PPA,
42 U.S.C. 13106. Congress established an initial list of toxic
chemicals that comprised more than 300 chemicals and 20 chemical
categories.
EPCRA section 313(d) authorizes EPA to add or delete chemicals from
the list and sets criteria for these actions. EPCRA section 313(d)(2)
states that EPA may add a chemical to the list if any of the listing
criteria in Section 313(d)(2) are met. Therefore, to add a chemical,
EPA must demonstrate that at least one criterion is met, but need not
determine whether any other criterion is met. The EPCRA section
313(d)(2) criteria are:
(A) The chemical is known to cause or can reasonably be anticipated
to cause significant adverse acute human health effects at
concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of continuous, or frequently
recurring, releases.
(B) The chemical is known to cause or can reasonably be anticipated
to cause in humans:
(i) Cancer or teratogenic effects, or
(ii) serious or irreversible--
(I) reproductive dysfunctions,
(II) neurological disorders,
(III) heritable genetic mutations, or
(IV) other chronic health effects.
(C) The chemical is known to cause or can be reasonably anticipated
to cause, because of:
(i) Its toxicity,
(ii) its toxicity and persistence in the environment, or
(iii) its toxicity and tendency to bioaccumulate in the
environment, a significant adverse effect on the environment of
sufficient seriousness, in the judgment of the Administrator, to
warrant reporting under this section.
EPA often refers to the section 313(d)(2)(A) criterion as the
``acute human health effects criterion;'' the section 313(d)(2)(B)
criterion as the ``chronic human health effects criterion;'' and the
section 313(d)(2)(C) criterion as the ``environmental effects
criterion.''
EPA published in the Federal Register of November 30, 1994 (59 FR
61432) a statement clarifying its interpretation of the section
313(d)(2) and (d)(3) criteria for modifying the section 313 list of
toxic chemicals.
III. Background Information
A. What is nonylphenol?
Nonylphenol is an organic chemical whose main use is in the
manufacture of nonylphenol ethoxylates, which are nonionic surfactants
used in a wide variety of industrial applications and consumer products
(Reference (Ref.) 1). Nonylphenol is persistent in the aquatic
environment, moderately bioaccumulative, and extremely toxic to aquatic
organisms (Ref. 1). Nonylphenol has also been detected in human breast
milk, blood, and urine (Ref. 1).
B. What is the chemical structure and identification of nonylphenol?
The chemical structure of nonylphenol consists of a phenol ring
(benzene with a hydroxyl (OH) group) with a nonyl group (a nine carbon
alkyl chain) attached to the phenol ring. The nonyl group can either be
a branched or linear chain located at various positions on the phenol
ring (primarily the ortho (2) and para (4) positions). Nonylphenol is
not a single chemical structure. Rather it is a complex mixture of
highly branched nonylphenols, mostly mono-substituted in the para
position (i.e., the 4 position), with small amounts of ortho- and di-
substituted nonylphenols. In addition, nonylphenol can include small
amounts of branched 8 carbon and 10 carbon alkyl groups (Ref. 2).
As noted in EPA's Action Plan for nonylphenol (Ref. 1), Chemical
Abstract Service Registry Numbers (CASRNs) that are routinely used for
nonylphenols may not accurately reflect the identity of those
substances. Manufacturers may incorrectly use a linear identity when
actually referring to branched nonylphenol. CASRN 84852-15-3
corresponds to the most widely produced nonylphenol, branched 4-
nonylphenol. Much of the literature refers to the linear (or normal)
nonylphenol (CASRN 25154-52-3) and there are also references to a
specific linear para isomer 4-n-nonylphenol (CASRN 104-40-5), which is
covered within the broader CASRN 25154-52-3. Many, but not all,
references may be inaccurate about the identity of the substances
listed as nonylphenol due to inaccurate identities in the source
material. A supplier of nonylphenol may use CASRN 104-40-5, signifying
the linear 4-n-nonylphenol, while actually supplying branched 4-
nonylphenol (CASRN 84852-15-3). The name 4-nonylphenol is listed as a
synonym under CASRN 104-40-5, which may lead to such confusion.
C. How is EPA proposing to list nonylphenol on the TRI?
Because there is no one CASRN that adequately captures what is
referred to as nonylphenol and because of the apparent confusion that
has resulted from the use of multiple CASRNs, EPA is proposing to add
nonylphenol as a category defined by a structure. EPA is proposing to
define the nonylphenol category using the structure and text presented
below.
[[Page 37179]]
[GRAPHIC] [TIFF OMITTED] TP20JN13.011
This category definition covers the chemicals that are included in
CASRNs 84852-15-3 as well as those 4 position isomers covered by CASRN
25154-52-3. Any nonylphenol that meets the above category definition
would be reportable regardless of its assigned CASRN.
IV. What Is EPA's evaluation of the environmental toxicity of
nonylphenol?
Nonylphenol is toxic to aquatic organisms and has been found in
ambient waters. Because of nonylphenol's toxicity, chemical properties,
and widespread use as a chemical intermediate, concerns have been
raised over the potential risks to aquatic organisms from exposure to
nonylphenol. All of the hazard information presented here has been
adapted from EPA's 2005 Water Quality Criteria document for
nonylphenol, which was previously peer reviewed (Ref. 3).
A. Acute Toxicity to Aquatic Animals
1. Freshwater Species. The acute toxicity values of nonylphenol to
freshwater organisms are shown in Table 1. Acute toxicities have been
determined for more than 18 species representing over 15 genera.
Toxicity values ranged from 21 micrograms per liter ([mu]g/L) for a
detritivorous amphipod (Hyalella aztecta) to 774 [mu]g/L for an algal
grazing snail (Physella virgata) (Ref. 4). No relationships were found
between nonylphenol toxicity and water hardness or pH.
An amphipod (Hyalella azteca) was the most sensitive species tested
with LC50 values (i.e., the concentration that is lethal to
50% of test organisms) ranging from 21 to 150 [mu]g/L (Refs. 4 and 5).
Reported EC50 values (i.e., the concentration that is
effective in producing a sublethal response in 50% of test organisms)
for the water flea (Daphnia magna) ranged from 104 to 190 [mu]g/L in
renewal and static tests respectively (Refs. 4 and 6). The overall mean
acute value for Daphnia magna was 141 [mu]g/L.
Species least sensitive to nonylphenol were also invertebrates. An
annelid worm (Lumbriculus variegatus) had an LC50 of 342
[mu]g/L, while the acute endpoint for a dragonfly nymph (Ophiogomphus
sp.) was an LC50 of 596 [mu]g/L (Ref. 4). The least
sensitive species tested was a snail (Physella virgata) with an
LC50 of 774 [mu]g/L. Eleven species of fish were tested and
found to be in the mid-range of sensitivity to nonylphenol with acute
values ranging from 110 to 360 [mu]g/L.
Table 1--Acute Toxicity of Nonylphenol to Freshwater Organisms
----------------------------------------------------------------------------------------------------------------
LC50 or
Species Common name Method \a\ pH EC50 Reference
([mu]g/L)
----------------------------------------------------------------------------------------------------------------
Hyalella azteca (juvenile, 2 Amphipod........ F, M.......... 7.80 21 Ref. 4.
mm total length).
Daphnia magna (< 24 hr old).. Water Flea...... R, M.......... 7.87 104 Ref. 4.
Etheostoma rubrum (0.062g, Fountain Darter. S, U.......... 8.0-8.1 110 Ref. 7.
20.2 mm).
Bufo boreas (0.012g, 9.6 mm). Boreal Toad..... S, U.......... 7.9-8.0 120 Ref. 7.
Pimephales promelas (25-35 Fathead Minnow.. F, M.......... 7.23 128 Ref. 8.
days old).
Oncorhynchus mykiss (0.27 Rainbow Trout... S, U.......... 7.9 140 Ref. 9.
0.07g).
Oncorhynchus clarki henshawi Lahontan S, U.......... 7.9 140 Ref. 9.
(0.34 0.08g). Cutthroat Trout.
Pimephales promelas (32 days Fathead Minnow.. F, M.......... 7.29 140 Refs. 10 and 11.
old).
Hyalella azteca (juvenile, 2- Amphipod........ F, M.......... 7.9-8.7 150 Ref. 5.
3mm total length).
Oncorhynchus clarki stomais Greenback S, U.......... 7.5-7.6 150 Ref. 9.
(0.31 0.17g). Cutthroat Trout.
Chironomus tentans (2nd Midge........... F, M.......... 8.0-8.4 160 Ref. 12.
instar).
Oncorhynchus mykiss (0.48 Rainbow Trout... S, U.......... 7.5-7.9 160 Ref. 9.
0.08g).
Oncorhynchus apache (0.38 Apache Trout.... S, U.......... 7.3-7.7 160 Ref. 9.
0.18g).
Xyrauchen texanus (0.31 0.04g).
Pimephales promelas (0.34 Fathead Minnow.. S, U.......... 7.5-7.6 170 Ref. 9.
0.24g).
Oncorhynchus mykiss (0.50 Rainbow Trout... S, U.......... 6.5-7.9 180 Ref. 9.
0.21g).
Oncorhynchus apache (0.85 Apache Trout.... S, U.......... 7.8-7.9 180 Ref. 9.
0.49g).
Daphnia magna (< 24 hr old).. Water Flea...... S, M.......... 8.25 190 Ref. 6.
Oncorhynchus mykiss (0.67 Rainbow Trout... S, U.......... 7.8-7.9 190 Ref. 9.
0.35g).
Xyrauchen texanus (0.32 0.07g).
Etheostoma lepidum (0.133g, Greenthroat S, U.......... 8.0-8.2 190 Ref. 7.
22.6 mm). Darter.
Lepomis macrochirus Bluegill........ F, M.......... 7.61 209 Ref. 4.
(juvenile).
Pimephales promelas (0.32 Fathead Minnow.. S, U.......... 7.7-8.1 210 Ref. 9.
0.16g).
Oncorhynchus clarki henshawi Lahontan S, U.......... 7.6-7.7 220 Ref. 9.
(0.57 0.23g). Cutthroat Trout.
Oncorhynchus mykiss (45 days Rainbow Trout... F, M.......... 6.72 221 Ref. 4.
old).
Poeciliopsis occidentalis Gila Topminnow.. S, U.......... 8.0 230 Ref. 7.
(0.22g, 27.2 mm).
Ptychocheilus lucius (0.32 Colorado S, U.......... 8.1-8.2 240 Ref. 9.
0.05g). Squawfish.
Oncorhynchus mykiss (1.25 Rainbow Trout... S, U.......... 7.5-7.7 260 Ref. 9.
0.57g).
[[Page 37180]]
Oncorhynchus mykiss (1.09 Rainbow Trout... S, U.......... 7.7-7.9 270 Ref. 9.
0.38g).
Gila elegans (0.29 0.08g).
Ptychocheilus lucius (0.34 Colorado S, U.......... 7.8-8.0 270 Ref. 9.
0.05g). Squawfish.
Pimephales promelas (0.39 Fathead Minnow.. S, U.......... 7.8-8.2 290 Ref. 9.
0.14g).
Pimephales promelas (0.45 Fathead Minnow.. S, U.......... 7.6-7.8 310 Ref. 9.
0.35g).
Gila elegans (0.52 0.09g).
Pimephales promelas (0.40 Fathead Minnow.. S, U.......... 7.5-7.9 330 Ref. 9.
0.21g).
Lumbriculus variegatus Annelid......... F, M.......... 6.75 342 Ref. 4.
(adult).
Pimephales promelas (0.56 Fathead Minnow.. S, U.......... 7.8-8.1 360 Ref. 9.
0.19g).
Ophiogomphus sp. (nymph)..... Dragonfly....... F, M.......... 8.06 596 Ref. 4.
Physella virgata (adult)..... Snail........... F, M.......... 7.89 774 Ref. 4.
----------------------------------------------------------------------------------------------------------------
\a\ S = Static; R = Renewal; F = Flow-through; M = Measured; U = Unmeasured.
2. Saltwater Species. The acute toxicity values of nonylphenol to
saltwater organisms are shown in Table 2. Acute toxicities have been
determined for 11 species within 11 genera. Acute toxicity values
ranged from 17 [mu]g/L for the winter flounder (Pleuronectes
americanus) (Ref. 13), to 310 [mu]g/L for the sheepshead minnow
(Cyprinodon variegatus) (Ref. 14).
A number of benthic invertebrates have been investigated including
a deposit-feeding clam (Mulinia lateralis) with an LC50 of
38 [mu]g/L (Ref. 13), a copepod (Acartia tonsa) with an LC50
of 190 [mu]g/L (Ref. 15), the American lobster (Homarus americanus)
with an LC50 of 71 [mu]g/L (Ref. 13), the mud crab
(Dyspanopeus sayii) with an LC50 greater than 195 [mu]g/L
(Ref. 13), and two amphipods (Leptocheirus plumulosus) with an
LC50 of 62 [mu]g/L (Ref. 13) and (Eohaustorius estuarius)
with an LC50 of 138 [mu]g/L (Ref. 16).
Table 2--Acute Toxicity of Nonylphenol to Saltwater Aquatic Organisms
----------------------------------------------------------------------------------------------------------------
LC50 or
EC50
Species Common name Method \a\ pH ([micro]g/ Reference
L)
----------------------------------------------------------------------------------------------------------------
Pleuronectes americanus (48 Winter Flounder. S, M.......... 7.8-8.2 17 Ref. 13.
hrs old).
Mulinia lateralis (embryo/ Coot Clam....... S, U.......... 7.8-8.2 38 Ref. 13.
larvae).
Mysidopsis bahia \b\ (< 24 Mysid Shrimp.... F, M.......... 7.3-8.2 43 Ref. 17.
hrs old).
Palaemonetes vulgaris (48 hrs Grass shrimp.... F, M.......... 7.8-8.2 59 Ref. 13.
old).
Americamysis bahia (< 24 hrs Mysid Shrimp.... F, M.......... 7.8-8.2 61 Ref. 13.
old).
Leptocheirus plumosus (adult) Amphipod........ F, M.......... 7.8-8.2 62 Ref. 13.
Menidia beryllina (juvenile). Inland F, M.......... 7.8-8.2 70 Ref. 13.
Silversides.
Homarus americanus (1st stage American Lobster R, U.......... 7.8-8.2 71 Ref. 13.
larvae).
Eohaustorius estuarius Amphipod........ S, U.......... missing 138 Ref. 16.
(adult).
Cyprinodon variegatus Sheepshead F, M.......... 7.8-8.2 142 Ref. 13.
(juvenile). Minnow.
Acartia tonsa (10-12 days Copepod......... S, U.......... missing 190 Ref. 15.
old).
Dyspanopeus sayii (4th and Mud Crab........ F, M.......... 7.8-8.2 > 195 Ref. 13.
5th stage larvae).
Cyprinodon variegatus Sheepshead F, M.......... 7.4-8.1 310 Ref. 14.
(juvenile). Minnow.
----------------------------------------------------------------------------------------------------------------
\a\ S = Static; R = Renewal; F = Flow-through; M = Measured; U = Unmeasured.
\b\ Note that there has been a taxonomic name change, Mysidopsis bahia is now Americamysis bahia, the original
names from the studies are used in this document to avoid any confusion.
B. Chronic Toxicity to Aquatic Animals
1. Freshwater Species. The chronic toxicity of nonylphenol to
freshwater animals has been studied in two fish and three invertebrate
species (Table 3). Of the invertebrates, a number of species of the
cladoceran (water fleas) genus Daphnia have been extensively tested for
chronic effects. Water flea (Ceriodaphnia dubia) neonates exhibited
reproductive impairment when exposed to nonylphenol for 7 days at 202
[micro]g/L and survival was impaired at concentrations of 377 [micro]g/
L (Ref. 18). Four to 24-hour old water fleas (Daphnia magna) showed a
reduction in the number of young per brood over 9 days of exposure to
concentrations as low as 48 [micro]g/L. Based on this study, a chronic
Lowest-Observed-Effect-Concentration (LOEC) was calculated to be 23
[micro]g/L for effects on brood production (Ref. 19). Water fleas
(Daphnia magna) exposed to 71 and 130 [micro]g/L nonylphenol for 21
days exhibited declines in both growth and adult survival rates (Ref.
6). In a separate 21-day life cycle study of water fleas (Daphnia
magna); growth, reproduction, and survival were all reduced at
concentrations of 158 [micro]g/L and above (Ref. 4).
Less than 24-hour-old midge (Chironomus tentans) larvae exposed to
concentrations of nonylphenol from 12 to 200 [micro]g/L and showed
significant declines in larval survival over the first 20 days of
exposure. The chronic toxicity value for survival was calculated as 62
[micro]g/L (Ref. 20).
A 91-day life stage test was conducted with the embryos and fry of
rainbow trout (Oncorhynchus mykiss) at concentrations from 6 to 114
[micro]g/L. Nearly all larvae were abnormal at the two highest exposure
concentrations (>= 53 [micro]g/L) (Ref. 4). Survival was reduced at >=
23 [micro]g/L and growth measured as both change in weight and length
was even more sensitive with measured decreases at concentrations as
low as 10 [micro]g/L. The chronic toxicity effect value for growth
(both weight and length) was calculated as 8 [micro]g/L (Ref. 4).
Embryos and larvae of the fathead minnow (Pimephales promelas) were
[[Page 37181]]
exposed in a 33-day early-life-stage test at nonylphenol concentrations
ranging from 3 to 23 [micro]g/L (Ref. 21). Hatching was delayed at the
two highest concentrations (14 and 23 [micro]g/L). Fathead minnow
survival was reduced at concentrations of 14 [micro]g/L and greater.
The survival chronic toxicity effect value for fathead minnows was
calculated to be 14 [micro]g/L (Ref. 21).
2. Saltwater Species. Two chronic toxicity tests have been
conducted with mysid shrimp (Mysidopsis bahia) (Ref. 22). The first
experiment was a 28-day exposure measuring survival, growth, and
reproduction. Shrimp survival was reduced by 18% on exposure to 9
[micro]g/L. Growth in length was the most sensitive endpoint with a 7%
reduction in length for animals exposed to 7 [micro]g/L and No-
Observed-Effect-Concentration (NOEC) and LOEC for growth responses of 4
and 7 [micro]g/L (Table 3).
The second experiment, a 28-day life-cycle test, examined the
effect of nonylphenol on brood release and growth (Ref. 23). Growth of
female mysids (Americamysis bahia) was reduced at concentrations at and
above 28 [micro]g/L. Brood production was the most sensitive endpoint
in this study. The average number of young per female-reproductive day
was reduced at concentrations >= 15 [micro]g/L. The NOECs and LOECs for
reproductive responses were 9 and 15 [micro]g/L.
Table 3--Chronic Toxicity of Nonylphenol to Aquatic Organisms
[Freshwater and Saltwater]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic
value
Species Common name Method \a\ \b\ pH range Endpoint Reference
([micro]g/
L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mysidopsis bahia \c\.............. Mysid Shrimp........ LC, SW............ 7.4-8.3 5 (NOEC x LOEC)1/2 Ref. 22.
Growth.
Oncorhynchus mykiss............... Rainbow Trout....... ESL, FW........... 6.97 8 (NOEC x LOEC)1/2 Ref. 4.
Growth.
Mysidopsis bahia \c\.............. Mysid Shrimp........ LC, SW............ 7.4-8.3 9 Survival............ Ref. 22.
Mysidopsis bahia \c\.............. Mysid Shrimp........ LC, SW............ 7.4-8.3 9 Reproduction........ Ref. 22.
Americamysis bahia................ Mysid Shrimp........ LC, SW............ Missing 12 (NOEC x LOEC)1/2 Ref. 23.
Total Number of
Young.
Pimephales promelas............... Fathead Minnow...... ELS, FW........... 7.1-8.2 14 Delayed Hatching; Ref. 21.
Survival.
Oncorhynchus mykiss............... Rainbow Trout....... ESL, FW........... 6.97 23 Survival............ Ref. 4.
Daphnia magna..................... Water Flea.......... LC, FW............ 8.04 23 (NOEC x LOEC)1/2 Ref. 19.
Total Number of
Young.
Americamysis bahia................ Mysid Shrimp........ LC, SW............ Missing 28 Growth.............. Ref. 23.
Daphnia magna..................... Water Flea.......... LC, FW............ 8.25 39 Number of Live Young Ref. 6.
Oncorhynchus mykiss............... Rainbow Trout....... ESL, FW........... 6.97 53 Abnormal Development Ref. 4.
Chironomus tentans................ Midge............... LC, FW............ 7.73 62 (NOEC x LOEC)1/2 20 Ref. 20.
d Survival.
Daphnia magna..................... Water Flea.......... LC, FW............ 8.25 71 Growth.............. Ref. 6.
Daphnia magna..................... Water Flea.......... LC, FW............ 8.25 130 Adult Survival...... Ref. 6.
Daphnia magna..................... Water Flea.......... LC, FW............ 8.46 158 (NOEC x LOEC)1/2 Ref. 4.
Growth and
Reproduction;
Survival.
Ceriodaphnia dubia................ Water Flea.......... LC, FW............ 8.3-8.6 202 Reproductive Ref. 18.
Impairment.
Ceriodaphnia dubia................ Water Flea.......... LC, FW............ 8.3-8.6 377 Survival............ Ref. 18.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ LC = life-cycle or partial life-cycle; ELS = early life-stage.
\b\ FW = Freshwater, SW = Saltwater.
\c\ Note that there has been a taxonomic name change, Mysidopsis bahia is now Americamysis bahia, the original names from the studies are used in this
document to avoid any confusion.
C. Toxicity to Aquatic Plants
1. Freshwater. Ecological toxicity data for freshwater plants was
available only for single-celled planktonic green alga (Selenastrum
capricornutum) (Ref. 24). Algae exposed to nonylphenol for 4 days had
an EC50 for effect on population growth rate of 410
[micro]g/L. The effect did not persist when the algae were transferred
to fresh, uncontaminated, growth medium.
2. Saltwater. Ecological toxicity data for saltwater plants are
available only for a single species of marine planktonic algae, a
diatom (Skeletonema costatum) (Ref. 25). The EC50 for
nonylphenol effect on vegetative growth was 27 [micro]g/L.
D. Bioaccumulation
1. Freshwater Species. Data on bioaccumulation of nonylphenol in
freshwater organisms was limited to two species of fish, fathead minnow
(Pimephales promelas) and bluegill (Lepomis macrochirus). Juvenile
fathead minnows exposed to 5 and 23 [micro]g/L nonylphenol for 27 days
showed non-lipid-normalized bioconcentration factors (BCF) of 271 and
344 respectively (Ref. 26). Values which had been normalized to
organism lipid content were approximately five times lower. A short-
term (4-day) bioassay indicated that tissue concentrations reached
steady-state within two days in both the fathead minnow and bluegill
(Ref. 27). Overall, lipid-normalized BCF's for fathead minnows in 4-
and 27-day tests ranged from 128 to 209 and for bluegills from 39 to 57
(Ref. 8). A 42-day exposure experiment using fathead minnows and
exposure concentrations of 0.4 to 3.4 [micro]g/L resulted in BCFs
ranging from 203 to 268 (Ref. 28).
2. Saltwater Species. Bioconcentration factors are available for
three species of marine animals; the blue mussel (Mytilus edulis), the
three-spined stickleback fish (Gasterosteus aculeatus), and a benthic
shrimp (Crangon crangon) (Ref. 29). Individuals of all three species
were exposed to carbon-14 (\14\C)-labeled nonylphenol for 16 days and
followed over a subsequent elimination period of 32 days. BCFs
[[Page 37182]]
ranged from a measured value in benthic shrimp of 79 to an estimated
value of 2,168 for the blue mussel.
E. Reproductive, Developmental, and Estrogenic Effects
Numerous investigations have demonstrated the estrogenic activity
of nonylphenol (see Refs. 30, 31, and 32 for reviews). The majority of
studies have been conducted with aquatic species and effects have been
demonstrated both in vitro and in vivo. While most of these studies
have been conducted on fish, a number of species of invertebrates have
also been examined.
1. Aquatic Invertebrates. Among invertebrates, estrogenic effects
have been demonstrated in a marine amphipod (Corophium volutator) at 10
[micro]g/L (Ref. 33) and larvae of a freshwater insect (Chironomus
riparis) at 2,000 [micro]g/L (Ref. 34). However, no estrogenic effects
were found in a marine copepod (Tisbe battagliai) at exposure
concentrations up to 55 [micro]g/L (Ref. 35).
2. In Vivo Responses in Fish. The protein vitellogenin, which is
produced in the liver, is a primary constituent in the yolk of the ova
of oviparous vertebrate species (i.e., species producing eggs which
hatch outside the body). Very little vitellogenin is produced in males
and increased vitellogenin production in males is an indication of
estrogenic effects. While nonylphenol has been shown to produce
estrogenic effects, estimates from studies on male rainbow trout
(Oncorhynchus mykiss) suggest that it is 2,000 to 3,000 times less
potent than natural estrogen (17 beta-estradiol) (Ref. 36).
Exposure to nonylphenol has been shown to increase vitellogenin
production in male rainbow trout (Oncorhynchus mykiss) at
concentrations from 10 to 100 [micro]g/L over periods of 4 hours to 3
days (Refs. 37, 38 and 39). Jobling and colleagues (Ref. 40) also found
increased vitellogenin production in male rainbow trout after 21 days
of exposure to nonylphenol concentrations of 20 and 54 [micro]g/L.
Similarly, Tremblay and van der Kraak (Ref. 41) found increased plasma
vitellogenin after 3 weeks of exposure to 50 [micro]g/L nonylphenol in
rainbow trout. Female rainbow trout are similarly sensitive with
vitellogenin induction occurring with exposures ranging from 8 to 86
[micro]g/L (Ref. 42). The study on female rainbow trout also noted that
nonylphenol exposure caused changes in several pituitary and hormone
plasma levels. Exposure to nonylphenol concentrations as low as 4
[micro]g/L led to vitellogenin induction in male green swordfish
(Xiphophorous helleri). In contrast, additional studies did not show
vitellogenin induction in rainbow trout exposed for 9 days at 109
[micro]g/L (Ref. 43) or the Atlantic salmon (Salmo trutta) exposed for
30 days to 20 [micro]g/L (Ref. 44).
Vitellogenin messenger ribonucleic acid (mRNA) is a direct
precursor to protein formation and increased production in rainbow
trout at concentrations of 10 to 14 [micro]g/L when exposed for 4 and
72 hours respectively (Ref. 3). Increased levels of plasma vitellogenin
and several pituitary and plasma hormone levels were observed in female
rainbow trout exposed to 8 and 86 [micro]g/L nonylphenol. The route of
exposure influenced vitellogenin induction in the fathead minnow with
an order of magnitude greater induction when exposed via water as
opposed to diet (Ref. 45).
Fish fecundity (i.e., the rate of production of young) is also
affected in various ways by nonylphenol exposure (Ref. 28).
Concentrations as low as 0.5 to 3.4 [micro]g/L, although not acutely
toxic, decreased the fecundity of fathead minnows at various times over
the reproductive season. At concentrations of approximately 0.1
[micro]g/L, fecundity was increased in fathead minnows. These results
suggest a possible hormetic response of fish fecundity to nonylphenol.
A number of studies have been performed with the fish Japanese
medaka (Oryzias latipes). Following hatch, a cohort of Japanese medaka
was exposed for 28 days and monitored for the following 55 days for
survival, growth, egg viability, egg production, and gonosomatic index
(GSI) (Ref. 46). No effects were noted at the lowest exposure
concentration of 1.93 [micro]g/L. However, in a 3-month exposure study
with the same species, effects were noted at 50 [micro]g/L and included
intersex (development of ovo-testis) and the sex ratio shifted in favor
of females (Ref. 47). Another study of Japanese medaka found that, in
fish exposed from fertilized egg to 60 days post-hatch, the LOEC for
vitellogenin induction was found to be 12 [micro]g/L (Ref. 48).
A two-generation (F0 and F1) flow-through
study exposed Japanese medaka from eggs to 60 days post-hatch of the
second (F1) generation at concentrations ranging from 4 to
183 [micro]g/L (Ref. 49). For the F0 generation, egg
hatchability was reduced by 48% at 187 [micro]g/L. Survival was reduced
at 60 days post-hatch for exposures at or above 18 [micro]g/L. However,
no differences in growth rates were observed in the F0
generation at any exposure concentration 60 days post-hatch. Induction
of ovo-testis was observed at 18 [micro]g/L with 20% of the fish
exhibiting external male characteristics having ovo-testis. At 51
[micro]g/L, all fish exhibited external female characteristics with 40%
containing ovo-testis. Spermatogenesis was observed in ovo-testis
containing fish exposed to 18 but not 51 [micro]g/L. Fecundity was not
affected by nonylphenol exposure. GSI of female fish was increased by
exposure to concentrations greater than 8 [micro]g/L.
Effects of exposure on the F1 generation were also
reported with no embryological abnormalities or hatching failures
observed at any of the treatment concentrations. Growth was also not
affected at 60 days post-hatch in the F1 generation.
However, the sex ratio as determined by secondary sexual
characteristics changed in favor of females (1:2) at concentrations
greater than 18 [micro]g/L. Induction of ovo-testis occurred at lower
concentrations in the F1 as opposed to the F0
generation (8 versus 18 [micro]g/L). All fish in the F1
generation with ovo-testis displayed external male characteristics and
the degree of oocyte development was not as complete as with the
F0 18 [micro]g/L treatment. The overall results suggest a
NOEC and LOEC of approximately 8 and 18 [micro]g/L respectively.
A multi-generational study has also been conducted for the rainbow
trout (Oncorhynchus mykiss) (Ref. 50). Exposure to concentrations of 1
and 10 [micro]g/L of adult males and females was intermittent over 4
months. Vitellogenin induction was increased in adult male fish exposed
to both 1 and 10 [micro]g/L. Male progeny of fish exposed to 10
[micro]g/L showed elevated plasma estradiol concentrations. Female
progeny showed elevated levels of plasma testosterone and vitellogenin
concentrations.
V. Rationale for Listing
EPA's technical evaluation of nonylphenol shows that it can
reasonably be anticipated to cause, because of its toxicity,
significant adverse effects in aquatic organisms. Toxicity values for
nonylphenol are available for numerous species of aquatic organisms.
The observed effects from nonylphenol exposure occur at very low
concentrations demonstrating that nonylphenol is highly toxic to
aquatic organisms. Data summarized in this document include acute
toxicity values for freshwater organisms ranging from 21 [micro]g/L for
a detritivorous amphipod to 774 [micro]g/L for an algal grazing snail.
Acute toxicity values for freshwater fish ranged from 110 [micro]g/L
for the fountain darter to 128 to 360 [micro]g/L for the fathead
minnow. Acute toxicity values for saltwater organisms ranged from 17
[micro]g/L for the winter flounder to
[[Page 37183]]
310 [micro]g/L for the sheepshead minnow. Chronic toxicity values are
also available for several aquatic species ranging from 5 [micro]g/L
for growth effects in mysid shrimp to 377 [micro]g/L for survival
effects in water fleas. Chronic toxicity values for rainbow trout
ranged from 8 [micro]g/L for effects on growth to 53 [micro]g/L for
abnormal development. Reproductive, developmental, and estrogenic
effects on aquatic organisms have also been reported for nonylphenol
with some effects observed at concentrations of 4 [micro]g/L or less.
Therefore, EPA believes that the evidence is sufficient for listing the
nonylphenol category on the EPCRA section 313 toxic chemical list
pursuant to EPCRA section 313(d)(2)(C) based on the available
ecological toxicity data.
EPA does not believe that it is appropriate to consider exposure
for chemicals that are highly toxic based on a hazard assessment when
determining if a chemical can be added for environmental effects
pursuant to EPCRA section 313(d)(2)(C) (see 59 FR 61440-61442).
Therefore, in accordance with EPA's standard policy on the use of
exposure assessments (59 FR 61432), EPA does not believe that an
exposure assessment is necessary or appropriate for determining whether
the nonylphenol category meets the criteria of EPCRA section
313(d)(2)(C).
VI. References
EPA has established an official public docket for this action under
Docket ID No. EPA-HQ-TRI-2012-0110. The public docket includes
information considered by EPA in developing this action, including the
documents listed below, which are electronically or physically located
in the docket. In addition, interested parties should consult documents
that are referenced in the documents that EPA has placed in the docket,
regardless of whether these referenced documents are electronically or
physically located in the docket. For assistance in locating documents
that are referenced in documents that EPA has placed in the docket, but
that are not electronically or physically located in the docket, please
consult the person listed in the above FOR FURTHER INFORMATION CONTACT
section.
1. USEPA. 2010. Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs)
Action Plan (RIN 2070-ZA09). United States Environmental Protection
Agency, Washington, DC. August 18, 2010.
2. Lorenc, J. F., Lambeth, G. and Scheffer, W. 2003. Alkylphenols.
Kirk-Othmer Encyclopedia of Chemical Technology, John Wiley & Sons,
Inc. 2:225.
3. USEPA. 2005. Aquatic Life Ambient Water Quality Criteria--
Nonylphenol Final. United States Environmental Protection Agency,
Washington, DC. Office of Water. EPA-822-R-05-005. December 2005.
4. Brooke, L.T. 1993a. Acute and chronic toxicity of nonylphenol to
ten species of aquatic organisms. Report to the U.S. EPA for Work
Assignment No. 02 of Contract No. 68-C1-0034. Lake Superior Research
Institute, University of Wisconsin-Superior, Superior, WI. March 24.
30 pp. Amended 18 October 2005. 34 pp.
5. England, D.E. and J.B. Bussard. 1995. Toxicity of nonylphenol to
the amphipod Hyalella azteca (Saussure). Report No. 41569. ABC
Laboratories, Inc., Columbia, MO. 178 pp.
6. Comber, M.H.I., T.D. Williams and K.M. Stewart. 1993. The effects
of nonylphenol on Daphnia magna. Wat. Res. 27: 273-276.
7. Dwyer, F.J., D.K. Hardesty, C.E. Henke, C.G. Ingersoll, D.W.
Whites, D.R. Mount and C.M. Bridges. 1999. Assessing contaminant
sensitivity of endangered and threatened species: Toxicant classes.
EPA/600/R-99/098. National Technical Information Service,
Springfield, VA. 15pp.
8. Brooke, L.T. 1993b. Nonylphenol Toxicity. Accumulation and
lethality for two freshwater fishes (fathead minnow and bluegill) to
nonylphenol. Report to the U.S. EPA for the Work Assignment No. 1-12
of Contract No. 68-C1-0034. Lake Superior Research Institute,
University of Wisconsin-Superior, WI. September 30. 50 pp.
9. Dwyer, F.J., L.C. Sappington, D.R. Buckler and S.B. Jones. 1995.
Use of surrogate species in assessing contaminant risk to endangered
and threatened fishes. EPA/600/R-96/029. National Technical
Information Service, Springfield, VA. 71 pp.
10. Holcombe, G.W., G.L. Phipps, M.L. Knuth and T. Felhaber. 1984.
The acute toxicity of selected substituted phenols, benzenes, and
benzoic acid esters to fathead minnows (Pimephales promelas).
Environ. Pollut. (Series A) 35: 367-381.
11. University of Wisconsin-Superior. 1985. Acute toxicities of
organic chemicals to fathead minnows (Pimephales promelas). Volume
II. D.L. Geiger, C.E. Northcott, D.J. Call, and L.T. Brooke (Eds.).
Center for Lake Superior Environmental Studies, University of
Wisconsin-Superior, Superior, WI. 326 pp.
12. England, D.E. and J.B. Bussard. 1993. Toxicity of nonylphenol to
the midge Chironomus tentans. Report No. 40597. ABC Laboratories,
Inc., Columbia, MO. 92 pp.
13. Lussier, S.M., D. Champlin, J. LiVolsi, S. Poucher and R.J.
Pruell. 2000. Acute toxicity of para-nonylphenol to saltwater
animals. Environ. Toxicol. Chem. 19: 617-621.
14. Ward, T.J. and R.L. Boeri. 1990a. Acute flow through toxicity of
nonylphenol to the sheepshead minnow, Cyprinodon variegatus.
EnviroSystems Study Number 8972-CMA, Hampton, NH. 34 pp.
15. Kusk, K.O. and L. Wollenberger. 1999. Fully defined saltwater
medium for cultivation of and toxicity testing with the marine
copepod Acartia tonsa. Environ. Toxicol. Chem. 20: 1564-1567.
16. Hecht, S. and B.L. Boese. 2002. Sensitivity of an infaunal
amphipod, Eohaustorius estuaries, to acute waterborne exposures of
4-nonylphenol: Evidence of a toxic hangover. Environ. Toxicol. Chem.
21: 816-819.
17. Ward, T.J. and R.L. Boeri. 1990b. Acute flow through toxicity of
nonylphenol to the mysid, Mysidopsis bahia. EnviroSystems Study
Number 8974-CMA, Hampton, NH. 35 pp.
18. England, D.E. 1995. Chronic toxicity of nonylphenol to
Ceriodaphnia dubia. Report No. 41756. ABC Laboratories, Inc.
Columbia, MO. 409 pp.
19. Fliedner, A. 1993. Daphnia magna Reproduction test (OECD) No.
202). Fraunhofer-Institute fur Umweltchemie und Okotoxikologie,
Posfach 1260, W-5948 Schmallenberg--Grafschaft, Germany. Report No.
UBA-002/4-22 February.
20. Kahl, M.D., E.A. Makynen, P.A. Kosian and G.T. Ankley. 1997.
Toxicity of 4-nonylphenol in a life-cycle test with the midge
Chironomus tentans. Ecotoxicol. Environ. Saf. 38: 155-160.
21. Ward, T.J. and R.L. Boeri. 1991a. Early life stage toxicity of
nonylphenol to the fathead minnow, Pimephales promelas.
EnviroSystems Study Number 8979-CMA, Hampton, NH. 59 pp.
22. Ward, T.J. and R.L. Boeri. 1991b. Chronic toxicity of
nonylphenol to the mysid, Mysidopsis bahia. EnviroSystems Study
Number 8977-CMA, Hampton, NH. 61 pp.
23. Kuhn, A., W.R. Munns, Jr., D. Champlin, R. McKinney, M.
Tagliabue, J. Serbst and T. Gleason. 2001. Evaluation of the
efficacy of extrapolation population modeling to predict the
dynamics of Americamysis bahia populations in the laboratory.
Environ. Toxicol. Chem. 20: 213-221.
24. Ward, T.J. and R.L. Boeri. 1990c. Acute static toxicity of
nonylphenol to the freshwater alga Selenastrum capricornutum.
EnviroSystems Study Number 8969-CMA, Hampton, NH. 41 pp.
25. Ward, T.J. and R.L. Boeri. 1990d. Acute static toxicity of
nonylphenol to the marine alga Skeletonema costatum. EnviroSystems
Study Number 8970-CMA, Hampton, NH. 42 pp.
26. Ward, T.J. and R.L. Boeri. 1991c. Bioconcentration test with
nonlylphenol and the Fathead Minnow, Pimephales promelas.
EnviroSystems Study Number 8975-CMA, Hampton, NH. 72 pp.
27. Brooke, L.T. 1994. Nonylphenol Analysis. Accumulation and
lethality for two freshwater fishes (fathead minnow and bluegill) to
nonylphenol. Report to the U.S. EPA for the Work Assignment No. 2-15
of Contract No. 68-C1-0034. Lake Superior Research Institute,
University of Wisconsin-Superior, WI. May 31. 49 pp.
[[Page 37184]]
28. Giesy, J.P., S.L. Pierens, E.M. Snyder, S. Miles-Richardson,
V.J. Kramer, S.A. Snyder, K.M. Nichols, and D.A. Villeneuve. 2000.
Effects of 4-nonylphenol on fecundity of biomarkers of estrogenicity
in fathead minnows (Pimephales promelas). Environ. Toxicol. Chem.
19: 1368-1377.
29. Ekelund, R., A. Bergman, A. Granmo, and M. Berggren. 1990.
Bioaccumulation of 4-nonylphenol in marine animals--A re-evaluation.
Environ. Poll. 64: 107-120.
30. Servos, M.R. 1999. Review of the aquatic toxicity, estrogenic
responses, and bioaccumulation of alkylphenols and alkylphenol
polyethoxylates. Wat. Qual. Res. J. Can. 34: 123-177.
31. Sonnenschein, C. and A.M. Soto. 1998. An updated review of
environmental estrogen and androgen mimics and antagonists. J.
Steroid Biochem. Molec. Biol. 65: 143-150.
32. Sumpter, J.P. 1998. Xenoendocrine disrupters--environmental
impacts. Toxicol. Lett. 102-103: 337-342.
33. Brown, R.J., M. Conradi, and M.H. Depledge. 1999. Long-term
exposure to 4-nonylphenol affects sexual differentiation and growth
of the amphipod Corophium volutator (Pallus, 1766). Sci. Total
Environ. 233: 77-88.
34. Hahn, T., K. Schenk, and R. Schulz. 2002. Environmental
chemicals with known endocrine potential affect yolk protein content
in the aquatic insect Chironomus riparius. Environ. Pollut. 120:
525-528.
35. Bechmann, R.K. 1999. Effect of the endocrine disruptor
nonylphenol on the marine copepod Tisbe battagliai. Sci. Total
Environ. 233: 33-46.
36. Islinger, M., S. Pawlowski, H. Hollert, A. Volkl, and T.
Braumbeck. 1999. Measurement of vitellogenin-mRNA expression in
primary cultures of rainbow trout hepatocytes in a non-radioactive
dot blot/RNAse protection-assay. Sci. Total Environ. 233:109-122.
37. Ren, L., D. Lattier, and J.J. Lech. 1996a. Estrogenic activity
in rainbow trout determined with a new cDNA probe for
vitellogenesis, pSG5Vg1.1. Bull. Environ. Contam. Toxicol. 56: 287-
294.
38. Ren, L., S.K. Lewis, and J.J. Lech. 1996b. Effects of estrogen
and nonylphenol on the post-transcriptional regulation of
vitellogenin gene expression. Chemico-Biol. Interact. 100: 67-76.
39. Lech, J.J., S.K. Lewis, and L. Ren. 1996. In vivo estrogenic
activity of nonylphenol in rainbow trout. Fund. Appl. Toxicol. 30:
229-232.
40. Jobling, S., D. Sheahan, J.A. Osborne, P. Matthiessen, and J.P.
Sumpter. 1996. Inhibition of testicular growth in rainbow trout
(Oncorhynchus mykiss) exposed to estrogenic alkylphenolic chemicals.
Environ. Toxicol. Chem. 15: 194-202.
41. Tremblay, L. and G. van der Kraak. 1998. Use of a series of
homologous in vitro and in vivo assays to evaluate the endocrine
modulating actions of beta-sitosterol in rainbow trout. Aquat.
Toxicol. 43: 149-162.
42. Harris, C.A., E.M. Santos, a. Janbakhsh, T.G. Pottinger, C.R.
Tyler, and J.P. Sumpter. 2001. Nonylphenol affects gonadotropin
levels in the pituitary gland and plasma of female rainbow trout.
Environ. Sci. Technol. 35: 2909-2916.
43. Pedersen, S.N. L.B. Christiansen, K.L. Pedersen, B. Korsgaard,
and P. Bjerregaard. 1999. In vivo estrogenic activity of branched
and linear alkylphenols in rainbow trout (Oncorhychus mykiss). Sci.
Tot. Environ. 233: 89-96.
44. Moore, A., A.P. Scott, N. Lower, I. Katsiadaki, and L.
Greenwood. 2003. The effects of 4-nonylphenol and atrazine on
Atlantic salmon (Salmo salar L.) smolts. Aquaculture 222: 253-263.
45. Pickford, K.A., R.E. Thomas-Jones, B. Wheals, C.R. Tyler, and
J.P. Sumpter. 2003. Route of exposure affects the oestrogenic
response of fish to 4-tert-nonylphenol. Aquat. Toxicol. 65: 267-279.
46. Nimrod, A.C. and W.H. Benson. 1998. Reproduction and development
of Japanese medaka following an early life stage exposure to
xenoestrogens. Aquat. Toxicol. 44: 141-156.
47. Gray, M.A. and C.D. Metcalfe. 1997. Induction of testis-ova in
Japanese medaka (Oryzias latipes) exposed to p-nonylphenol. Environ.
Toxicol. Chem. 16: 1082-1086.
48. Seki, M., H. Yokota, M. Maeda, H. Tadokoro, and K. Kobayashi.
2003. Effects of 4-nonylphenol and 4-tert-octylphenol on sex
differentiation and vitellogenin induction in medaka (Oryzias
latipes). Environ. Toxicol. Chem. 22: 1507-1516.
49. Yokota, H., M. Seki, M. Maeda, Y. Oshima, H. Tadokoro, T. Honjo,
and K. Kobayashi. 2001. Life-cycle toxicity of 4-nonylphenol to
medaka (Oryzias latipes). Environ. Toxicol. Chem. 20: 2552-2560.
50. Schwaiger, J., U. Mallow, H. Ferling, S. Knoerr, T. Braunbeck,
W. Kalbfus, and R.D. Negele. 2000. How estrogenic is nonylphenol? A
transgenerational study using rainbow trout (Oncorhynchus mykiss) as
a test organism. Aquat. Toxicol. 59: 177-189.
51. USEPA, OEI. Economic Analysis of the Proposed Rule to add
Nonylphenol to the EPCRA Section 313 List of Toxic Chemicals. June
11, 2013.
VII. What are the Statutory and Executive Order Reviews associated with
this action?
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act
This proposed rule does not contain any new information collection
requirements that require additional approval by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et. seq. Currently, the facilities subject to the reporting
requirements under EPCRA 313 and PPA 6607 may use either the EPA Toxic
Chemicals Release Inventory Form R (EPA Form 9350-1), or the EPA Toxic
Chemicals Release Inventory Form A (EPA Form 9350-2). The Form R must
be completed if a facility manufactures, processes, or otherwise uses
any listed chemical above threshold quantities and meets certain other
criteria. For the Form A, EPA established an alternative threshold for
facilities with low annual reportable amounts of a listed toxic
chemical. A facility that meets the appropriate reporting thresholds,
but estimates that the total annual reportable amount of the chemical
does not exceed 500 pounds per year, can take advantage of an
alternative manufacture, process, or otherwise use threshold of 1
million pounds per year of the chemical, provided that certain
conditions are met, and submit the Form A instead of the Form R. In
addition, respondents may designate the specific chemical identity of a
substance as a trade secret pursuant to EPCRA section 322 42 U.S.C.
11042: 40 CFR part 350.
OMB has approved the reporting and recordkeeping requirements
related to Forms A and R, supplier notification, and petitions under
OMB Control number 2025-0009 (EPA Information Collection Request (ICR)
No. 1363) and those related to trade secret designations under OMB
Control 2050-0078 (EPA ICR No. 1428). As provided in 5 CFR 1320.5(b)
and 1320.6(a), an Agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control numbers
relevant to EPA's regulations are listed in 40 CFR part 9, 48 CFR
chapter 15, and displayed on the information collection instruments
(e.g., forms, instructions).
For the 57 Form Rs and 13 Form As expected to be filed, EPA
estimates the industry reporting and recordkeeping burden for
collecting this information to average, in the first year, $246,429
(based on 4,874 total burden hours) (Ref. 51). In subsequent years, the
burden for collecting this information is estimated to average $117,350
(based on 2,321 total burden hours). These estimates include the time
needed to become familiar with the requirement (first-year
[[Page 37185]]
only); review instructions; search existing data sources; gather and
maintain the data needed; complete and review the collection
information; and transmit or otherwise disclose the information. The
actual burden on any facility may be different from this estimate
depending on the complexity of the facility's operations and the
profile of the releases at the facility. Upon promulgation of a final
rule, the Agency may determine that the existing burden estimates in
the ICRs need to be amended in order to account for an increase in
burden associated with the final action. If so, the Agency will submit
an information collection worksheet (ICW) to OMB requesting that the
total burden in each ICR be amended, as appropriate.
C. Regulatory Flexibility Act (RFA), as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.
The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions. For purposes of assessing the impacts of
today's rule on small entities, small entity is defined as: (1) A
business that is classified as a ``small business'' by the Small
Business Administration at 13 CFR 121.201; (2) a small governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) a small organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. Of the 70
entities estimated to be impacted by this proposed rule, 34 are small
businesses. Of the affected small businesses, all 34 are projected to
have cost-to-revenue impacts of less than 1% in both the first and
subsequent years of the rulemaking. Facilities eligible to use Form A
(those meeting the appropriate activity threshold which have 500 pounds
per year or less of reportable amounts of the chemical) will have a
lower burden. No small governments or small organizations are expected
to be affected by this action. Thus this rule is not expected to have a
significant adverse economic impact on a substantial number of small
entities. A more detailed analysis of the impacts on small entities is
located in EPA's economic analysis support document (Ref. 51). We
continue to be interested in the potential impacts of the proposed rule
on small entities and welcome comments on issues related to such
impacts.
D. Unfunded Mandates Reform Act
This rule does not contain a Federal mandate that may result in
expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or the private sector in any one year.
EPA's economic analysis indicates that the total cost of this rule is
estimated to be $246,722 in the first year of reporting. Thus, this
rule is not subject to the requirements of sections 202 or 205 of UMRA.
This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. Small governments
are not subject to the EPCRA section 313 reporting requirements.
E. Executive Order 13132 (Federalism)
This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This action relates to toxic
chemical reporting under EPCRA section 313, which primarily affects
private sector facilities. Thus, Executive Order 13132 does not apply
to this action.
In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed action
from State and local officials.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action
relates to toxic chemical reporting under EPCRA section 313, which
primarily affects private sector facilities. Thus, Executive Order
13175 does not apply to this action. In the spirit of Executive Order
13175, and consistent with EPA policy to promote communications between
EPA and Indian Tribal Governments, EPA specifically solicits additional
comment on this proposed action from tribal officials.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it does not establish an environmental standard intended
to mitigate health or safety risks.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing,
[[Page 37186]]
as appropriate, disproportionately high and adverse human health or
environmental effects of their programs, policies, and activities on
minority populations and low-income populations in the United States.
EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This proposed rule adds an additional chemical to the
EPCRA section 313 reporting requirements. By adding a chemical to the
list of toxic chemicals subject to reporting under section 313 of
EPCRA, EPA would be providing communities across the United States
(including minority populations and low income populations) with access
to data which they may use to seek lower exposures and consequently
reductions in chemical risks for themselves and their children. This
information can also be used by government agencies and others to
identify potential problems, set priorities, and take appropriate steps
to reduce any potential risks to human health and the environment.
Therefore, the informational benefits of the proposed rule will have a
positive impact on the human health and environmental impacts of
minority populations, low-income populations, and children.
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, and Toxic chemicals.
Dated: June 14, 2013.
Bob Perciasepe,
Acting Administrator.
Therefore, it is proposed that 40 CFR part 372 be amended as
follows:
PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW
0
1. The authority citation for part 372 continues to read as follows:
Authority: 42 U.S.C. 11023 and 11048.
0
2. The table in Sec. 372.65 paragraph (c) is amended by adding an
entry in alphabetical order for ``Nonylphenol'' to read as follows:
Sec. 372.65 Chemicals and chemical categories to which the part
applies.
* * * * *
(c) * * *
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[FR Doc. 2013-14754 Filed 6-19-13; 8:45 am]
BILLING CODE 6560-50-P