[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Proposed Rules]
[Pages 37176-37186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14754]
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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.
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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: [email protected].
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: [email protected], 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, http://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
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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 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,
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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 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