[Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)]
[Proposed Rules]
[Pages 59186-59195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23253]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721
[EPA-HQ-OPPT-2007-0490; FRL-9912-87]
RIN 2070-AJ96
Certain Nonylphenols and Nonylphenol Ethoxylates; Significant New
Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing a significant new use rule (SNUR) for 15 related chemical
substances commonly known as nonylphenols (NP) and nonylphenol
ethoxylates (NPE). For 13 NPs and NPEs, EPA is proposing to designate
any use as a ``significant new use,'' and for 2 additional NPs, EPA is
proposing that any use other than use as an intermediate or use as an
epoxy cure catalyst would constitute a ``significant new use.'' Persons
subject to these SNURs would be required to notify EPA at least 90 days
before they manufacture (including import) or process any of these 15
chemical substances for a significant new use. The required
notification would provide EPA with the opportunity to evaluate the new
uses and protect against unreasonable risks, if any, from potential new
exposures to NPs and NPEs, before that activity occurs.
DATES: Comments must be received on or before December 1, 2014.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-0490, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
[[Page 59187]]
FOR FURTHER INFORMATION CONTACT: For technical information regarding
the SNUR, contact: Jeffrey Taylor, Chemical Control Division (7405M),
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone number: (202) 564-8828; email address:
[email protected].
For general information, contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by these actions if you manufacture
(including import) or process any of the chemical substances covered by
this proposed SNUR. The North American Industrial Classification System
(NAICS) codes that are identified in this unit are not intended to be
exhaustive, but rather provide a guide to help readers determine
whether this rule applies to them. Potentially affected entities may
include:
Manufacturers (including importers) or processors of one
or more of the subject chemical substances (North American Industrial
Classification System (NAICS) codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
Surface active agent manufacturers (NAICS code 325613).
This action may also affect certain entities due to pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B. In addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after October
31, 2014 are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
To determine whether you or your business may be affected by this
action, you should carefully examine the applicability of provisions in
40 CFR 721.5. If you have any questions regarding the applicability of
this action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use (15 U.S.C.
2604(a)(1)(B)). As described in Unit V., the general SNUR provisions
are found at 40 CFR part 721, subpart A.
C. What action is the agency taking?
EPA is proposing a SNUR for 15 NPs and NPEs. EPA is proposing to
designate any use of the 13 NPs and NPEs listed in Table 1 of Unit
II.A. as a significant new use, and any use other than use as an
intermediate or use as an epoxy cure catalyst as a significant new use
of the 2 additional NPs listed in Table 2 of Unit II.A.
This proposed SNUR would apply to the uses that are not ongoing at
the time of this proposed rule. Uses not ongoing at the time of the
proposal would be designated significant new uses in the final SNUR.
EPA is requesting public comment on this proposal, and specifically on
whether the Agency has correctly identified the current and ongoing
uses of the 15 NPs and NPEs covered by this proposed rule. EPA is
particularly interested in whether anyone is currently using these
chemicals in a manner that is not described in this proposal.
Persons subject to a SNUR would be required to notify EPA at least
90 days before commencing manufacture (including import) or processing
of any of the subject chemical substances for a significant new use,
consistent with the requirements at 40 CFR 721.25.
D. Why is the agency taking this action?
This proposed SNUR is necessary to ensure that EPA receives timely
advance notice of any future manufacturing and processing of these
chemical substances for the designated new uses to allow the Agency to
evaluate any potential changes in human and environmental exposures.
The rationale and objectives for this proposed SNUR are explained in
Unit III.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substances included in this proposed rule. This analysis,
which is available in the docket, is discussed in Unit IX., and is
briefly summarized here. In the event that a SNUN is submitted, costs
are estimated at approximately $8,589 per SNUN submission for large
business submitters and $6,189 for small business submitters. These
estimates include the cost to prepare and submit the SNUN and the
payment of a user fee. In addition, for persons exporting a substance
that is the subject of a SNUR, a one-time notice must be provided for
the first export or intended export to a particular country, which is
estimated to cost less than $100 on average per notification.
Since EPA is unable to predict whether anyone might engage in
future activities that would require reporting, potential total costs
are estimated to range from $0 to less than $10,000.
II. Chemical Substances Subject to This Proposed Rule
A. What chemicals are subject to this proposed SNUR?
This proposed SNUR would apply to the 15 NPs and NPEs in Tables 1
and 2 of this unit. To ascertain whether these chemicals are currently
in commerce, EPA analyzed uses that are described in Unit II.B, and
also reviewed the most recent data from EPA's Chemical Data Reporting
(CDR) database (Ref. 1). Twelve of the 13 linear NPs and NPEs in Table
1 of this unit are not reported on CDR. One NPE chemical, known as
poly(oxy-1,2-ethanediyl), [alpha](nonylphenyl)-[omega]-hydroxy-(CASRN
9016-45-9), also listed in Table 1 of this unit, was reported to the
2012 CDR. EPA believes, however, that the manufacturer incorrectly
identified the chemical in its CDR report, and that, in fact, poly(oxy-
1,2-ethanediyl), [alpha](nonylphenyl)-[omega]-hydroxy-(CASRN 9016-45-9)
is not currently manufactured for any use. The manufacturer reported
the chemical identity as a linear form of NPE, but the available
information indicates that the manufacturer should have reported the
[[Page 59188]]
identity as a branched NPE. Based on chemical engineering literature
and industry expert sources, as described later in this unit, EPA's
understanding is that only branched forms of NP and NPE chemical
substances are currently manufactured for commercial purposes. The two
chemical substances listed in Table 2 were both reported to the 2012
CDR and are used as an intermediate and as an epoxy cure catalyst.
Table 1--NPs and NPEs for Which Any Use Is a Significant New Use
----------------------------------------------------------------------------------------------------------------
Chemical
Abstracts
Chemical name Chemical abstracts index name Service NP or NPE
Registry No.
(CASRN)
----------------------------------------------------------------------------------------------------------------
4-nonylphenol......................... Phenol, 4-nonyl-..................... 104-40-5 NP
2-[2-[2-[2-(4- Ethanol, 2-[2-[2-[2-(4- 7311-27-5 NPE
nonylphenoxy)ethoxy]ethoxy]ethoxy]eth nonylphenoxy)ethoxy]ethoxy]ethoxy]-.
anol.
[alpha](Nonylphenyl)-[omega]-hydroxy- Poly(oxy-1,2-ethanediyl), 9016-45-9 NPE
poly(oxy-1,2-ethanediyl). [alpha](nonylphenyl)-[omega]-hydroxy-
.
2-[2-(4-nonylphenoxy)ethoxy]ethanol... Ethanol, 2-[2-(4-nonylphenoxy)ethoxy]- 20427-84-3 NPE
.
Nonylphenol........................... Phenol, nonyl-....................... 25154-52-3 NP
[alpha]-(4-Nonylphenyl)-[omega]- Poly(oxy-1,2-ethanediyl), [alpha]-(4- 26027-38-3 NPE
hydroxy-poly(oxy-1,2-ethanediyl). nonylphenyl)-[omega]-hydroxy-.
2-[2-[2-[2-[2-[2-[2-[2-[2- 3,6,9,12,15,18,21,24-Octaoxahexacosan- 26571-11-9 NPE
(Nonylphenoxy)ethoxy]ethoxy]ethoxy]et 1-ol, 26-(nonylphenoxy)-.
hoxy]ethoxy]ethoxy]ethoxy]ethoxy]etha
nol.
2-[2-(Nonylphenoxy)ethoxy]ethanol..... Ethanol, 2-[2-(nonylphenoxy)ethoxy]-. 27176-93-8 NPE
2-[2-[2-[2-[2-[2-[2-[2- 3,6,9,12,15,18,21-Heptaoxatricosan-1- 27177-05-5 NPE
(nonylphenoxy)ethoxy]ethoxy]ethoxy]et ol, 23-(nonylphenoxy)-.
hoxy]ethoxy]ethoxy]ethoxy]ethanol.
2-[2-[2-[2-[2-[2-[2-[2-[2-[2- 3,6,9,12,15,18,21,24,27- 27177-08-8 NPE
(nonylphenoxy)ethoxy]ethoxy]ethoxy]et Nonaoxanonacosan-1-ol, 29-
hoxy]ethoxy]ethoxy]ethoxy]ethoxy]etho (nonylphenoxy)-.
xy]ethanol.
2-(Nonylphenoxy)ethanol............... Ethanol, 2-(nonylphenoxy)-........... 27986-36-3 NPE
[alpha]-(Isononylphenyl)-[omega]- Poly(oxy-1,2-ethanediyl), [alpha]- 37205-87-1 NPE
hydroxy-poly(oxy-1,2-ethanediyl). (isononylphenyl)-[omega]-hydroxy-.
[alpha]-(2-Nonylphenyl)-[omega]- Poly(oxy-1,2-ethanediyl), [alpha]-(2- 51938-25-1 NPE
hydroxy-poly(oxy-1,2-ethanediyl),. nonylphenyl)-[omega]-hydroxy-.
----------------------------------------------------------------------------------------------------------------
Table 2--NPs for Which Any Use Other Than as an Intermediate or Epoxy Cure Catalyst Is a Significant New Use
----------------------------------------------------------------------------------------------------------------
Chemical
Abstracts
Chemical name Chemical abstracts index name Service NP or NPE
Registry No.
(CASRN)
----------------------------------------------------------------------------------------------------------------
4-nonylphenol, branched............... Phenol, 4-nonyl-, branched........... 84852-15-3 NP
2-nonylphenol, branched............... Phenol, 2-nonyl-, branched........... 91672-41-2 NP
----------------------------------------------------------------------------------------------------------------
NPs and NPEs consist of a nine carbon nonyl group in either
branched or linear form bound at various positions (ortho, meta, or
para) around a phenol ring. Nonylphenol is produced by the acid-
catalyzed reaction of nonene and phenol. The degree of branching of the
nonene used in that reaction determines the degree of branching in the
product NP. EPA's understanding of the chemistry and engineering of
commercial NP production is that it starts with nonene that is produced
by acid-catalyzed propylene trimerization. Nonene produced in this way
is a complex mixture of highly branched alkenes and contains negligible
amounts of linear olefins. Manufacturers combine this highly branched
nonene with phenol in an acid-catalyzed reaction. This reaction pathway
is described in the literature and industry publications. For example,
the Kirk-Othmer Encyclopedia of Chemical Technology states, ``All
commercially produced PNP [para-nonylphenol, or 4-nonylphenol] is made
from nonene based on the trimerization of propylene'' (and therefore is
highly branched) (Ref. 2). Similarly, industry assessments state that
commercial nonene (used to make NP) does not contain linear
C9H18 alpha-olefin; rather, it is a complex
mixture of highly branched, predominantly nine-carbon olefins known as
propylene trimers (Ref. 3). Additionally, some industrial sources
assert that linear NP is a laboratory chemical substance that is not
used in commerce and is not a degradant found in the environment (Ref.
4).
During the development of a testing consent order on 4-nonylphenol
(Ref. 5), the Alkylphenols and Ethoxylates Panel of the American
Chemistry Council (ACC) confirmed EPA's assessment, stating that, as it
is currently manufactured, nonylphenol is a substance comprising mostly
branched C9-alkyl phenols and is best represented by 4-nonylphenol,
Chemical Abstract Services Registry Number (CASRN) 84852-15-3.
B. What are the uses and production levels of the NPs and NPEs covered
by this proposed SNUR?
Branched 4-nonylphenol (CASRN 84852-15-3), in Table 2 of this unit,
was reported to the 2012 CDR at 100-500 million pounds production
volume. Branched 2-nonylphenol (CASRN 91672-41-2), also in Table 2 of
this unit, was reported to the 2012 CDR at 1-10 million pounds
production volume.
Linear NPE, poly(oxy-1,2-ethanediyl), [alpha](nonylphenyl)-[omega]-
hydroxy-(CASRN 9016-45-9), in Table 1 of this unit, was reported to the
2012 CDR with a 2011 production volume ranging from 10 million to 50
million pounds. As described earlier in this unit, EPA believes that
this linear NPE was incorrectly identified and the manufacturer was in
fact producing a branched NPE (i.e., another chemical entirely). The
other 12 linear NPs and NPEs have no reported production volume on the
2012 CDR. Nonylphenol (CASRN 25154-52-3), in Table 1 of this unit, was
initially reported to the 2012
[[Page 59189]]
CDR, but EPA understands that the chemical should have been reported as
either branched NP CASRN 84852-15-3 or branched NP CASRN 91672-41-2.
Companies who reported nonylphenol with CASRN 25154-52-3 to the 2012
CDR have corrected their reports, which results in the chemical having
no production volume on the 2012 CDR.
Certain NPs are used primarily as intermediates to produce other
chemical substances, notably NPEs. NPEs are manufactured by reacting
the hydroxyl group (-OH) of NP with ethylene oxide in an iterative
process, forming a combination of NPEs of various chain lengths,
typically ranging from 4 to 80 ethoxylate (EO) groups. The commonly-
used NPEs have chain lengths averaging 8 to 12 EO groups, and
commercial NPEs will contain NPEs of various chain lengths. Different
degrees of ethoxylation impart different properties, which make the
chemical substances useful in a variety of applications.
EPA accessed information from the 2012 CDR database, along with the
Household Products Database and the Consumer Product Information
Database, in order to analyze use of NPs and NPEs broadly within U.S.
commerce (Refs. 1, 6, and 7). Reported NPs are used as intermediates to
create NPEs, and they are also used as epoxy cure catalysts. Reported
NPEs are used in a wide range of applications, and can be found in
consumer products related generally to home care, personal hygiene,
automotive, and lawn care. Specifically, the NPEs are used in: Laundry
detergents, engine and battery cleaners, all-purpose cleaners, paints,
metal polishers, stain pretreatment, sealants, paint/varnish strippers,
wallpaper removers, hand cleaners, floor strippers, disinfectant/mold
inhibitors, concrete cleaners, tile/grout cleaners, degreasers, brush
cleaners, tile adhesives, and wood finishes (Refs. 1, 6, 7, 8, and 9).
C. What are the potential environmental effects of, and routes and
sources of exposure to, the NPs and NPEs covered by this proposed SNUR?
NPs and NPEs with only one or two EO groups are persistent, low-to-
moderately bioaccumulative, and highly toxic to aquatic organisms. In
general, toxicity to environmental organisms increases with decreasing
degrees of ethoxylation for nonylphenolic compounds, with NPs being
most toxic. NPEs with greater degrees of ethoxylation, while less
toxic, degrade to the more toxic and persistent, less ethoxylated forms
of these chemical substances in the environment. Available data
indicate that these chemical substances are highly toxic to fish and
invertebrates, causing lethality on an acute basis and effects on
survival, growth, development, metabolism, reproduction, and fecundity
with low-level chronic exposures (Refs. 10 and 11). EPA has established
water quality criteria for NPs of 6.6 microgram per litre ([micro]g/L)
for acute exposures and 1.7 [micro]g/L for chronic exposures (Ref. 12).
EPA has not established water quality criteria for NPEs. Environment
Canada has also established a concern level for NPs (and NPEs, as
expressed in NP toxic equivalency units) of 0.7 [micro]g/L for
indefinitely chronic exposures (Refs. 12 and 13). EPA recognizes that
NPs and NPEs may be endocrine bioactive (Refs. 14, 15, 16, 17, 18, 19,
20, 21, 22, 23, and 24).
Certain NPs and NPEs are produced in large volumes, with uses in a
wide range of applications (e.g., home care, personal hygiene,
automotive, and lawn care consumer products) that lead to widespread
releases to the aquatic environment. NPEs are clear to light orange
oily liquids or waxy solids, and are considered to be chemically stable
and unreactive (Ref. 25). NPEs show a gradual, linear increase in water
solubility with greater degree of ethoxylation (e.g., the reported
water solubility of NP with five ethoxyl groups attached, NP5EO, is
9.48 mg/L; and the reported water solubility of NP with twelve ethoxyl
groups attached, NP12EO, is 42.5 mg/L) (Refs. 26 and 27). The most
important processes affecting the persistence, distribution, and
bioavailability of nonylphenolic substances in the environment are
biodegradation and sorption (Refs. 28, 29, 30, and 31). NPEs with
greater degrees of ethoxylation degrade to less ethoxylated forms of
these chemical substances in the environment. NPEs with fewer degrees
of ethoxylation continue to degrade slowly to NPs. NPs, especially
highly branched NPs, degrade most slowly (Refs. 8 and 9). The aerobic
and anaerobic biodegradation of NPEs occurs through different reaction
pathways resulting in the formation of different degradation products.
Under aerobic conditions, evidence shows that carboxylated NPEs (NPECs)
of higher ethoxamers are quickly formed (e.g., NP9EC from NP9EO),
followed by shortening of the ethoxylate chain through the
deethoxylation pathway (e.g., NP2EC from NP9EC), and oxidation of the
nonyl chain to form dicarboxylated derivatives. Such dicarboxylated
products are referred to as carboxylated nonylphenyl
ethoxycarboxylates, or CAPECs. Under anaerobic conditions, the dominant
degradation pathways for NPEs is most likely deethoxylation (e.g.,
NP1EO and NP2EO from higher ethoxamers) and O-dealkylation (e.g., NP
from NP2EO) (Refs. 32 and 33). The resistance of NPs to further
degradation under anaerobic conditions is a contributing factor to
their accumulation in sludge.
Ecological receptors can potentially be significantly exposed to
NPs and NPEs under current manufacturing practices as a result of
surface water discharges from facilities that manufacture products
containing NPs or NPEs (Ref. 34). Once released into the environment,
NPs and NPEs tend to partition to sediments and accumulate (Ref. 35).
Thus, even if the discharges decrease, or cease, environmental
exposures can continue.
A range of levels of NPs and NPEs have been measured in surface
water and sediment in U.S. waters. Certain NPEs are widely used in
industrial processes and cleaning products, including industrial
laundry detergents, and are frequently found in wastewater and sewage
treatment plant effluents, with subsequent discharge into the
environment (Ref. 36). Localized monitoring studies have found surface
waters near industrial discharges contained NPs in concentrations
ranging from 2 to 1,617 [mu]g/L (Ref. 37) and NP concentrations in more
diffuse surface water and sediments in the Great Lakes ranging from
0.01 to 0.92 [mu]g/L for water and 37 to 300 [mu]g/g for sediments
(Ref. 36). In surface water samples collected along the Ohio River,
total NPEs ranged from 0.13 to 1.0 [mu]g/L for water, from 250 to 1,020
[mu]g/g for sediments, and from 32 to 920 [mu]g/g for carp, a bottom
dwelling fish (Ref. 38). Some of the measured surface water
concentrations, particularly those near industrial discharges, exceeded
the EPA Water Quality Criteria set for freshwater species living in the
water column. Nonylphenol has also been found in Minnesota lakes, with
maximum concentrations reaching 20 ng/L (Ref. 39). NPs and NPEs in
freshwater and saltwater ecosystems can potentially cause ecological
effects on all trophic levels of aquatic species exposed to them (Ref.
12).
III. Rationale and Objective
A. Rationale
NPs and short-chain NPE ethoxymers (NP with one ethoxyl group
attached, NP1EO, and NP with two ethoxyl groups attached, NP2EO) are
persistent, low-moderately bioaccumulative, and highly toxic to aquatic
organisms. Available data indicate that these
[[Page 59190]]
substances are highly toxic to fish and invertebrates, causing
lethality on an acute basis and effects on survival, growth,
development, metabolism, reproduction, and fecundity with low-level
chronic exposures (Refs. 10 and 11). Exposure occurs through industrial
and wastewater discharges that ultimately reach surface waters and
sediments. NPs and NPEs can potentially cause ecological effects on all
trophic levels of aquatic species exposed to them in freshwater and
saltwater ecosystems (Ref. 12).
Of the 13 linear NPs and NPEs listed in Table 1 of Unit II.A., 12
of the chemical substances were not reported to the 2012 CDR. One of
these 13 substances was reported to the 2012 CDR, but as discussed in
Unit II.B., the available information indicates that the chemical
substance is not currently being manufactured or is otherwise used or
distributed in commerce. The two branched NPs listed in Table 2 of Unit
II.A. are not in use except as intermediates and epoxy cure catalysts.
Based on the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
these chemical substances, EPA is concerned that future manufacturing
or processing of these 15 NP and NPE chemicals could have the potential
to significantly increase the magnitude and duration of environmental
exposures. As previously discussed, based on current use and
manufacturing practices, NPEs are frequently found in wastewater and
sewage treatment plant effluents, with subsequent discharge into the
environment. EPA has no reason to anticipate that future manufacturing
practices and uses are likely to result in lower discharges.
Accordingly, EPA has determined that individual evaluation of the
activities associated with those new uses is warranted to allow the
Agency to determine whether any controls are necessary before such
manufacturing (including importing) or processing starts or resumes.
The required notification provided by a SNUN would provide EPA with the
opportunity to evaluate the new uses and protect against unreasonable
risks, if any, from potential new exposures to NPs and NPEs.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate under
TSCA before the manufacturing or processing for that use begins. Since
the new use does not currently exist, deferring a detailed
consideration of potential risks or hazards related to that use is an
effective use of resources. If a person decides to begin manufacturing
or processing the chemical substance for the use, the notice to EPA
allows the Agency to evaluate the use according to the specific
parameters and circumstances surrounding that intended use.
B. Objective
Based on the considerations in Unit IV.A., EPA wants to achieve the
following objectives through this action:
1. EPA would receive notice of any person's intent to manufacture
(including import) or process the 15 NPs and NPEs for the described
significant new uses before that activity begins.
2. EPA would have an opportunity to review and evaluate any data
submitted in a SNUN before the notice submitter begins manufacturing
(including importing) or processing of the 15 NPs and NPEs for the
described significant new use.
3. EPA would be able to regulate prospective manufacturers
(including importers) or processors of these chemical substances before
the described significant new use of the chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
1. The projected volume of manufacturing and processing of a
chemical substance.
2. The extent to which a use changes the type or form of exposure
of human beings or the environment to a chemical substance.
3. The extent to which a use increases the magnitude and duration
of exposure of human beings or the environment to a chemical substance.
4. The reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of a chemical
substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use of the 15
NPs and NPEs subject to this proposed rule, EPA considered relevant
information about the toxicity of the substances, exposures,
environmental releases, and the four factors listed in section 5(a)(2)
of TSCA.
EPA has preliminarily determined that any use of the 13 linear NPs
and NPEs listed in Table 1 of Unit II.A. is a significant new use. EPA
has also preliminarily determined that any use of the branched NPs
listed in Table 2 of Unit II.A., other than use as an intermediate or
use as an epoxy cure catalyst, is a significant new use. As discussed
previously in this unit, EPA is concerned that future manufacturing or
processing of these 15 NP and NPE chemicals could have the potential to
significantly increase the magnitude and duration of environmental
exposures, and EPA has no reason to anticipate that future
manufacturing practices and uses are likely to result in lower
discharges.
V. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule.
Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submission requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA sections 5(e), 5(f), 6,
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
Persons who export or intend to export a chemical substance that is
the subject of a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Such
persons must certify that the shipment of the chemical
[[Page 59191]]
substance complies with all applicable rules and orders under TSCA,
including any SNUR requirements. The EPA policy in support of import
certification appears at 40 CFR part 707, subpart B.
VI. Applicability of the Rule to Uses Occurring Before Effective Date
of the Final Rule
As discussed in the Federal Register of April 24, 1990 (55 FR
17376) (FRL-3658-5), EPA has decided that the intent of section
5(a)(1)(B) of TSCA is best served by designating a use as a significant
new use as of the date of publication of the proposed rule rather than
as of the effective date of the final rule. If uses that had begun
after the proposed rule was published were considered ongoing rather
than new, any person could defeat the SNUR by initiating the
significant new use before the final rule was issued. Therefore, EPA
designates October 1, 2014 as the cutoff date for determining whether
any of the uses that are the subject of this proposal are ongoing.
Persons who begin commercial manufacture or processing of the chemical
substances for a significant new use identified as of that date would
have to cease any such activity upon the effective date of the final
rule. To resume their activities, these persons would have to first
comply with all applicable SNUR notification requirements and wait
until the notice review period, including any extensions, expires. If
such a person met the conditions of advance compliance under 40 CFR
721.45(h), the person would be considered exempt from the requirements
of the SNUR. Consult the Federal Register final rule of April 24, 1990
for a more detailed discussion of the cutoff date for ongoing uses.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not usually require
developing any particular test data before submission of a SNUN. There
are two exceptions:
Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)); and
Development of test data may be necessary where the
chemical substance has been listed under TSCA section 5(b)(4) (see TSCA
section 5(b)(2)).
In the absence of a section 4 test rule or a section 5(b)(4)
listing covering the chemical substance, persons are required to submit
only test data in their possession or control and to describe any other
data known to or reasonably ascertainable by them (15 U.S.C. 2604(d);
40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA
recommends that SNUN submitters include data that would permit a
reasoned evaluation of risks posed by the chemical substance during its
manufacture, processing, use, distribution in commerce, or disposal.
EPA encourages persons to consult with the Agency before submitting a
SNUN. As part of this optional pre-notice consultation, EPA would
discuss specific data that may be useful in evaluating a significant
new use. SNUNs submitted for significant new uses without any test data
may increase the likelihood that EPA will take action under TSCA
section 5(e) to prohibit or limit activities associated with this
chemical substance.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance,
2. Potential benefits of the chemical substance, and
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
VIII. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the substance. According to 40
CFR[emsp14]721.1(c), persons submitting a SNUN must comply with the
same notice requirements and EPA regulatory procedures as persons
submitting a PMN, including submission of test data on health and
environmental effects as described in 40 CFR 720.50. SNUNs must be
submitted on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
40 CFR[emsp14]721.25 and 40 CFR 720.40. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
A. SNUNs
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substance included in this proposed rule (Ref. 40). In the
event that a SNUN is submitted, costs are estimated at approximately
$8,589 per SNUN submission for large business submitters and $6,189 for
small business submitters. These estimates include the cost to prepare
and submit the SNUN, and the payment of a user fee. Businesses that
submit a SNUN would be subject to either a $2,500 user fee required by
40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual
sales of less than $40 million when combined with those of the parent
company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)).
EPA's complete economic analysis is available in the public docket for
this proposed rule (Ref. 40).
B. Export Notification
Under TSCA section 12(b) and the implementing regulations at 40 CFR
part 707, subpart D, exporters must notify EPA if they export or intend
to export a chemical substance or mixture for which, among other
things, a rule has been proposed or promulgated under TSCA section 5.
For persons exporting a substance that is the subject of a SNUR, a one-
time notice must be provided for the first export or intended export to
a particular country. The total costs of export notification will vary
by chemical substance, depending on the number of required
notifications (i.e., the number of countries to which the chemical
substance is exported). EPA is unable to make any estimate of the
likely number of export notifications for the chemical substance
covered in this proposed SNUR.
X. Alternatives
Before proposing the SNUR, EPA considered the following alternative
regulatory actions:
A. Promulgate a TSCA Section 8(a) Reporting Rule
Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the Agency when they
intend to manufacture (including import) or process a listed chemical
substance for a specific use or any use. However, for the 15 NPs and
NPEs subject to this proposed rule, the use of TSCA section 8(a) rather
than SNUR authority would have several limitations. First, if EPA were
to require reporting under TSCA section 8(a) reporting for new uses
instead of TSCA section 5(a), then EPA would not have the opportunity
to review human and environmental hazards and exposures associated with
the proposed significant new use and, if necessary, take immediate
follow-up regulatory action under TSCA sections 5(e) or 5(f) to
prohibit or limit the activity before it begins. In addition,
[[Page 59192]]
EPA may not receive important information from small businesses because
such firms generally are exempt from TSCA section 8(a) reporting
requirements. In view of the level of environmental concerns about the
15 NPs and NPEs, EPA believes that a TSCA section 8(a) rule for this
substance would not meet EPA's regulatory objectives.
B. Regulate NPs and NPEs Under TSCA Section 6
Under TSCA section 6, EPA may regulate a chemical substance if
``the Administrator finds that there is a reasonable basis to conclude
that the manufacture, processing, distribution in commerce, use or
disposal of a chemical substance or mixture . . . presents or will
present an unreasonable risk of injury to health or the environment''
(TSCA section 6(a)). Because EPA believes that the 13 NP and NPE
chemical substances listed in Table 1 of Unit II.A. are not being used
and the 2 NPs listed in Table 2 of Unit II.A. are not being used other
than as an intermediate or epoxy cure catalyst, EPA concluded that risk
management action under TSCA section 6 is not warranted at this time.
EPA believes that this proposed SNUR would allow the Agency to
effectively address concerns surrounding any proposed significant new
use, should they arise, by requiring prior notice of the use and
allowing EPA a 90-day review period in which EPA would evaluate the use
and could take action, as appropriate, under TSCA sections 5(e), 5(f),
6, or 7 to control the activities on which it has received the SNUN.
XI. Request for Comment
A. Do you have comments or information about ongoing uses?
EPA welcomes comment on all aspects of this proposed rule. EPA
based its understanding of the use profile of these chemical substances
on the 2012 CDR submissions, engineering literature, and communications
with industry representatives. To confirm EPA's understanding, the
Agency is requesting public comment on all aspects of this proposed
rule, including the commercial production of linear forms of NPs and
NPEs, as well as any ongoing uses of the subject chemical substances.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
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.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
XII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA (2013). Chemical Data Reporting. August 7, 2014; Available
from: http://www.epa.gov/cdr.
2. Lorenc, J.F., Lambeth, Gregory, and Scheffer, William (2000).
Alkylphenols. Kirk-Othmer Encyclopedia of Chemical Technology.
3. Klecka, G.M., Staples, C.A., Losey, B.S., and Woodburn, K.B.
(2005). APERC Assessment of the Persistence and Bioaccumulation
Potential for Nonylphenol, Octylphenol, and Their Ethoxylates for
Categorization and Screening of the Canadian Domestic Substance List
(DSL).
4. APERC (2010). Statement on EPA Estrogenic Screening Results for
Nonylphenol and Nonylphenol Ethoxylates.
5. EPA (1990). Testing Consent Order on 4-Nonylphenol, Branched.
Final Rule. 55 FR 5991.
6. NIH (2013). Household Products Database: Nonylphenol and
Nonylphenol Ethoxylates. August 6, 2014; Available from: http://hpd.nlm.nih.gov/index.htm.
7. CPID (2013). Consumer Product Information Database: Nonylphenol
and Nonylphenol Ethoxylates. August 6, 2014; Available from: http://whatsinproducts.com/index.php.
8. EPA (2010). Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs)
Action Plan.
9. EPA (2009). Testing of Certain Nonylphenol and Nonylphenol
Ethoxylate Substances: Advance Notice of Proposed Rulemaking
(ANPRM). 40 CFR part 799.
10. Staples, C., Mihaich, E., Carbone, J., Woodburn, K., and Klecka,
G. (2004). A Weight-of-Evidence of the Chronic Ecotoxicity of
Nonylphenol Ethoxylates, Nonylphenol Ether Carboxylates, and
Nonylphenol. Human and Ecological Risk Assessment. 10: p. 999-1017.
11. Servos, M.R. (1999). Review of the Aquatic Toxicity, Estrogenic
Responses, and Bioaccumulation of Alkylphenols and Alkylphenol
Polyethoxylates. Water Quality Research Journal of Canada. 34: p.
123-1777.
12. EPA (2005). Ambient Aquatic Life Water Quality Criteria--
Nonylphenol Final. (EPA-822-R-05-005).
13. Canada (2002). Canadian Environmental Quality Guidelines for
Nonylphenol and its Ethoxylates (Water, Sediment, and Soil)
Scientific Supporting Document. Ecosystem Health: Science-Based
Solutions Report. No. 1-3.
14. Balaguer, P., Franois, F., Comunale, F., Fenet, H., Boussioux,
A.M., Pons, M., Nicolas, J.C., and Casallas, C. (1999). Reporter
cell lines to study the estrogenic effects of xenoestrogens. Science
Total Environment. 233: p. 47-56.
15. Blair, R.M., Fang, H., Branham, W.S., Hass, B.S., Dial, S.L.,
Moland, C.L., Tong, W., Shi, L., Perkins, R. and Sheehan, D.M.
(2000). The estrogen receptor relative binding affinities of 188
natural and xenochemicals: Structural diversity of ligands.
Toxicological Sciences. 54(138-153).
16. Bonefeld-J[oslash]rgensen, E., Long, M, Hofmeister, M.V., and
Vinggaard, A.M. (2007). Endocrine-Disrupting Potential of Bisphenol
A, Bisphenol A Dimethacrylate, 4-n-Nonylphenol, and 4-n-Octylphenol
in Vitro: New Data and a Brief Review. Environmental Health
Perspectives. 115(S-1): p. 69-76.
[[Page 59193]]
17. Danzo, B.J. (1997). Environmental xenobiotics may disrupt normal
endocrine function by interfering with the binding of physiological
ligands to steroid receptors and binding proteins. Environmental
Health Perspectives. 105(3): p. 294-301.
18. Legler, J., Van Den Brink, C.E., Brouwer, A., Murk, A.J., Van
Der Saag, P.T., Vethaak, A.D., and Van Der Burg, B. (1999).
Development of a stably transfected estrogen receptor-mediated
luciferase reporter gene assay in the human T47D breast cancer cell
line. Toxicological Sciences. 48(55-66).
19. Satoh, K., Nagai, F., and Aoki, N. (2001). Several environmental
pollutants have binding affinities for both androgen receptor and
estrogen receptor. Journal of Health Science. 47(5): p. 495-501.
20. White, R., Jobling, S., Hoare, S., Sumpter, J., and Parker, M.
(1994). Environmentally persistent alkylphenolic compounds are
estrogenic. Endocrinology. 135(1): p. 175-182.
21. Lee, H., Chattopadhyay, Soma, Gong, Eun-Yeung, Ahn, Ryun Sup,
and Lee, Keesook (2003). Antiandrogenic Effects of Bisphenol A and
Nonylphenol on the Function of Androgen Receptor. Toxicological
Sciences. 75: p. 40-45.
22. Gong, Y., Han, X.D. (2006). Effect of nonylphenol on
steroidogenesis of rat Leydig cells. Journal of Environmental
Science and Health. 41(5): p. 705-15.
23. Kortner, T., Vang, S.H., Arukwe, A. (2009). Modulation of salmon
ovarian steroidogenesis and growth factor responses by the
xenoestrogen, 4-nonylphenol. Chemosphere. 77(7): p. 989-98.
24. RTI-International (2007). Characterization of the inhibition of
aromatase activity by nonylphenol. EPA Task Order 3. p. 158.
25. SEPA (2010). Scottish Pollutant Release Inventory; Pollutant
Fact Sheet, Nonylphenol Ethoxylates. Scottish Environment Protection
Agency.
26. Ahel, M., and Giger, W. (1993). Aqueous Solubility of
Alkylphenols and Alkyphenol Polyethoxylates. Chemosphere. 26(8): p.
1461-1470.
27. Brix, R., Hvidt, S., and Carlsen, L. (2001). Solubility of
Nonylphenol and Nonylphenol Ethoxylates: On the Possible Role of
Micelles. Chemosphere. 44: p. 759-763.
28. Ahel, M., Giger, W., and Schaffner, C. (1994). Behaviour of
alkylphenol polyethoxylate surfactants in the aquatic environment--
II. Occurrence and transformation in rivers. Water Research. 28(5):
p. 1143-1152.
29. Kvestak, R., Terzic, S., and Ahel, M. (1994). Input and
distribution of alkylphenol polyethoxylates in a stratified estuary.
Marine Chemistry. 46(1-2): p. 89-100.
30. Sekela, M., Brewer, R., Moyle, G., and Tuominen, T. (1999).
Occurrence of an environmental estrogen (4-nonylphenol) in sewage
treatment plant effluent and the aquatic receiving environment.
Water Science and Technology. 39(10-11): p. 217-220.
31. John, D.M., House, W.A., and White, G.F. (2000). Environmental
fate of nonylphenol ethoxylates: Differential adsorption of homologs
to components of river sediment. Environmental Toxicology and
Chemistry. 19(2): p. 293-300.
32. Jonkers, N., Knepper, T.P., and De Voogt, P. (2001). Aerobic
Biodegradation Studies of Nonylphenol Ethoxylates in River Water
Using Liquid Chromatography-Electrospray Tandem Mass Spectrometry.
Environ. Sci. Technol. 35(2): p. 335-340.
33. Giger, W., Brunner, P.H., and Schaffner, C. (1984). 4-
Nonylphenol in sewage sludge: accumulation of toxic metabolites from
non ionic surfactants. Science. 225: p. 623-625.
34. Ellis, D.D., Jones, C.M., Larson, R.A., and Schaeffer, D.J.
(1982). Organic constituents of mutagenic secondary effluents from
wastewater treatment plants. Archives of Environmental Contamination
and Toxicology. 11: p. 373-382.
35. Naylor, C.G., Mieure, J.P., Adams, W.J., Weeks, J.A., Castaldi,
F.J., Ogle, F.D., and Romano, R.R. (1992). Alkylphenol ethoxylates
in the environment. Journal of the American Oil Chemists' Society.
69: p. 695-708.
36. Bennett, E.R., and Metcalf, C.D. (1997). Distribution of
Alkylphenol Compounds in Great Lakes Sediments. Environmental
Toxicology and Chemistry. 17(7): p. 1230-1235.
37. Shackelford, W.M., Cline, D.M., Faas, L., and Kurth, G. (1983).
Evaluation of automated spectrum matching for survey identification
of wastewater components by gas chromatography-mass spectrometry.
National Technical Information Service. (PB83-182931).
38. Rice, C.P., Schmitz-Afonso, I., Loyo-Rosales, J.E., Link, E.,
Thoma, R., Fay, L, Altfater, D., and Camp, M.J. (2003). Alkylphenol
and Alkylphenol-Ethoxylates in Carp, Water, and Sediment from the
Cuyahoga River, Ohio. Environ. Sci. Technol. 37(17): p. 3747-3754.
39. Ferrey, M. (2013). Pharmaceuticals and Endocrine Active
Chemicals in Minnesota Lakes. Minnesota Pollution Control Agency.
40. EPA (2014). Economic Analysis of the Significant New Use Rule
for Nonylphenols (NPs) and Nonylphenol Ethoxylates (NPEs).
XIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
The Office of Management and Budget (OMB) has determined that is
proposed SNUR is not a ``significant regulatory action,'' under section
3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993).
Accordingly, this action was not submitted to OMB for review under
Executive Order 12866 and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR
1320.3(b). The information collection activities associated with
existing chemical SNURs are already approved by OMB under OMB control
number 2070-0038 (EPA ICR No. 1188); and the information collection
activities associated with export notifications are already approved by
OMB under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity
were to submit a SNUN to the Agency, the annual burden is estimated to
be less than 100 hours per response, and the estimated burden for an
export notifications is less than 1.5 hours per notification. In both
cases, burden is estimated to be reduced for submitters who have
already registered to use the electronic submission system.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this SNUR would not have a
significant economic impact on a substantial number of small entities.
The rationale supporting this conclusion is as follows.
A SNUR applies to any person (including small or large entities)
who intends to engage in any activity described in the rule as a
``significant new use.'' By definition of the word ``new'' and based on
all information currently available to EPA, it appears that no small or
large entities presently engage in such activity. Since this SNUR will
require a person who intends to engage in such activity in the future
to first notify EPA by submitting a SNUN, no economic impact will occur
unless someone files a SNUN to pursue a significant new use in the
future or forgoes profits by avoiding or delaying the significant new
use. Although some small entities may decide to conduct such activities
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemical substances, the
Agency receives only a handful of notices per year. During the six year
period from 2005-2010, only three submitters self-identified as small
in their SNUN submission. EPA believes the cost of submitting a SNUN is
relatively small compared to the cost of developing and marketing a
chemical new to a firm and that the requirement
[[Page 59194]]
to submit a SNUN generally does not have a significant economic impact.
Therefore, EPA has determined that the potential economic impact of
complying with this SNUR is not expected to be significant or adversely
impact a substantial number of small entities. In a SNUR that published
as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the
Agency presented its general determination that proposed and final
SNURs are not expected to have a significant economic impact on a
substantial number of small entities, which was provided to the Chief
Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to be of the opinion that
any State, local, or Tribal government would be impacted by this
rulemaking. As such, EPA has determined that this regulatory action
would not impose any enforceable duty, contain any unfunded mandate, or
otherwise have any effect on small governments subject to the
requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-
1538.
E. Executive Order 13132: Federalism
This action will not have a substantial direct effect on States, on
the relationship between 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 (64 FR 43255, August
10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This proposed rule does not have Tribal implications because it is
not expected to have any effect (i.e., there will be no increase or
decrease in authority or jurisdiction) on Tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, the requirements of Executive Order
13175 (65 FR 67249, November 9, 2000) do not apply to this rulemaking.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this action is not intended to
address environmental health or safety risks affecting children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
Since this action does not involve any technical standards, section
12(d) of the NTTAA, 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This proposed rule does not entail special consideration of
environmental justice related issues as delineated by Executive Order
12898 (59 FR 7629, February 16, 1994) because EPA has determined that
this action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations.
This action does not affect the level of protection provided to human
health or the environment.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 24, 2014.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. 721.10765 to subpart E to read as follows:
Sec. 721.10765 Nonylphenols and nonylphenol ethoxylates.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances listed in Table 1 and Table 2 of
this section are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) For the chemical substances listed in Table 1 of this section,
any use.
(ii) For the chemical substances listed in Table 2 of this section,
any use other than as an intermediate or an epoxy cure catalyst.
Table 1--NP and NPE Chemical Substances Subject to Reporting Any Use
----------------------------------------------------------------------------------------------------------------
Chemical
Abstracts
Chemical name Chemical abstracts index name Service NP or NPE
Registry No.
(CASRN)
----------------------------------------------------------------------------------------------------------------
4-nonylphenol......................... Phenol, 4-nonyl-..................... 104-40-5 NP
2-[2-[2-[2-(4- Ethanol, 2-[2-[2-[2-(4- 7311-27-5 NPE
nonylphenoxy)ethoxy]ethoxy]ethoxy]eth nonylphenoxy)ethoxy]ethoxy]ethoxy]-.
anol.
[alpha](Nonylphenyl)-[omega]-hydroxy- Poly(oxy-1,2-ethanediyl), 9016-45-9 NPE
poly(oxy-1,2-ethanediyl). [alpha](nonylphenyl)-[omega]-hydroxy-
.
2-[2-(4-nonylphenoxy)ethoxy]ethanol... Ethanol, 2-[2-(4-nonylphenoxy)ethoxy]- 20427-84-3 NPE
.
Nonylphenol........................... Phenol, nonyl-....................... 25154-52-3 NP
[alpha]-(4-Nonylphenyl)-[omega]- Poly(oxy-1,2-ethanediyl), [alpha]-(4- 26027-38-3 NPE
hydroxy-poly(oxy-1,2-ethanediyl). nonylphenyl)-[omega]-hydroxy-.
2-[2-[2-[2-[2-[2-[2-[2-[2- 3,6,9,12,15,18,21,24-Octaoxahexacosan- 26571-11-9 NPE
(Nonylphenoxy)ethoxy]ethoxy]ethoxy]et 1-ol, 26-(nonylphenoxy)-.
hoxy]ethoxy]ethoxy]ethoxy]ethoxy]etha
nol.
2-[2-(Nonylphenoxy)ethoxy]ethanol..... Ethanol, 2-[2-(nonylphenoxy)ethoxy]-. 27176-93-8 NPE
2-[2-[2-[2-[2-[2-[2-[2- 3,6,9,12,15,18,21-Heptaoxatricosan-1- 27177-05-5 NPE
(nonylphenoxy)ethoxy]ethoxy]ethoxy]et ol, 23-(nonylphenoxy)-.
hoxy]ethoxy]ethoxy]ethoxy]ethanol.
[[Page 59195]]
2-[2-[2-[2-[2-[2-[2-[2-[2-[2- 3,6,9,12,15,18,21,24,27- 27177-08-8 NPE
(nonylphenoxy)ethoxy]ethoxy]ethoxy]et Nonaoxanonacosan-1-ol, 29-
hoxy]ethoxy]ethoxy]ethoxy]ethoxy]etho (nonylphenoxy)-.
xy]ethanol.
2-(Nonylphenoxy)ethanol............... Ethanol, 2-(nonylphenoxy)-........... 27986-36-3 NPE
[alpha]-(Isononylphenyl)-[omega]- Poly(oxy-1,2-ethanediyl), [alpha]- 37205-87-1 NPE
hydroxy-poly(oxy-1,2-ethanediyl). (isononylphenyl)-[omega]-hydroxy-.
[alpha]-(2-Nonylphenyl)-[omega]- Poly(oxy-1,2-ethanediyl), [alpha]-(2- 51938-25-1 NPE
hydroxy-poly(oxy-1,2-ethanediyl),. nonylphenyl)-[omega]-hydroxy-.
----------------------------------------------------------------------------------------------------------------
Table 2--NP and NPE Chemical Substances Subject to Reporting Any Use
Other Than as an Intermediate or an Epoxy Cure Catalyst
------------------------------------------------------------------------
Chemical
Chemical Abstracts
Chemical name abstracts index Service NP or
name Registry No. NPE
(CASRN)
------------------------------------------------------------------------
4-nonylphenol, branched...... Phenol, 4-nonyl- 84852-15-3 NP
, branched.
2-nonylphenol, branched...... Phenol, 2-nonyl- 91672-41-2 NP
, branched.
------------------------------------------------------------------------
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Persons who must report. Section 721.5 applies to this section
except Sec. 721.5(a)(2).
A person who intends to manufacture, import, or process for
commercial purpose a substance identified in paragraph (a)(2)(i) of
this section and intends to distribute the substance in commerce must
submit a significant new use notice.
(2) [Reserved]
[FR Doc. 2014-23253 Filed 9-30-14; 8:45 am]
BILLING CODE 6560-50-P