[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Proposed Rules]
[Pages 37176-37186]
[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)

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_ADDRESS>     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<PHONE_NUMBER>, and the telephone number for the OEI
Docket is<PHONE_NUMBER>.

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:<PHONE_NUMBER>; fax number: 202-
566-0677; email<EMAIL_ADDRESS>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<PHONE_NUMBER> in Virginia and
Alaska or toll free, TDD<PHONE_NUMBER>, 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

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.

[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).

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

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

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

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.

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

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,

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) * * *
    [GRAPHIC] [TIFF OMITTED] TP20JN13.012

[FR Doc. 2013-14754 Filed 6-19-13; 8:45 am]
BILLING CODE 6560-50-P


March 3, 2004 Honorable Craig Benson Governor of New Hampshire State House Concord, NH 03301 Dear Governor Benson:

Thank you for your letter forwarding New Hampshire= s recommendations on air quality designations for the national health based standards for fine particles. We received your letter on February 23, 2004.

Your letter is an important step toward providing citizens in your state with critical information about air pollution levels in their community. We intend to carefully review the recommendations and work with the New Hampshire Department of Environmental Services in determining final designations. The EPA must make its final official designation decisions for fine particles by December 31, 2004.

We look forward to working with New Hampshire in the coming months on designations for the fine particle standards. If you have any questions, please do not hesitate to call me or Tim Williamson, Acting Manager of the Air Quality Planning Unit, at 617 918 1099.

Sincerely,

Robert W. Varney Regional Administrator cc: Michael P. Nolin, Commissioner, DES Robert Scott, Air Resources Director, DES


Comment Info: =================

General Comment:Dear Mr. Zeller:

I write to you as an individual consumer and do hereby request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On my behalf, I request that the comment period for the Proposed Rule be extended by the FDA for an additional period of at least 105 days, from the current 75-day period, to a total of at least 180 days.

The Proposed Rule raises many significant issues and questions that are of extreme importance and relevance to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks a large number of different questions that I may wish to submit a response to. For those questions I may wish to provide my thoughts and comments on in relation to these issues, my available time to devote to researching and providing thoughtful and substantive comments on these extremely important questions is quite limited. I have to date invested a large number of hours researching, investigating and analyzing  these issues. I am aware that the FDA has taken many years to develop the Proposed Rule and thus do believe it is not at all unreasonable to allow me and all interested individuals of the general public an additional six month period to comment on these very significant and complex issues. We have but one opportunity, as consumers who are directly affected by the Proposed Rule, to provide relevant and substantive information regarding this issue to the FDA.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Simply put, I firmly believe that they have saved my life. I therefore wish to provide you with my personal testament, as well as scientific analysis and evidence-based responses to your questions so that you may consider my comment throughout this process. The FDA has the authority under 21 CFR 10.40 to extend this time frame and the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, such that all stakeholders may have the opportunity to submit their comments on this proposed regulation.

I sincerely appreciate your kind consideration of my request and would be happy to discuss any issues with you at your request.


Modular Rater Application

I, (Name of Rater) 	, hereby assert that I meet or exceed all required capabilities and qualifications to provide inspection and testing services as a Rater under the ENERGY STAR Modular Home Program as indicated by completing the information on this form. Also, I hereby state that I do not have financial interests in or maintain any affiliation with the construction, sale or completion of a home, nor do I provide services that might affect my capacity to evaluate compliance with the ENERGY STAR program and render reports of findings objectively and without bias. Other persons performing ENERGY STAR services under my authority also meet these requirements.

Authorized company

representative: 	 Company:

Signature: 	 Date:

Address:

City/State/Zip:

Telephone:______________________  Fax:_____________________ E-Mail:

Rater must complete the following:

Modular housing design, construction and installation methods

(Must check all boxes below)

(	Working knowledge of the residential building codes

(	Knowledge of modular home design, construction, installation, material use, and fabrication

Building science and energy efficiency experience

(Must check at least one box below)

(	Certified Home Energy Rating System (HERS) rater

Submit this form to SBRA:

	  Fax number:<PHONE_NUMBER>, or

	  Mailing address: 2109 Broadway, Suite 200, New York, NY 10023, or

  E-Mail<EMAIL_ADDRESS> If approved, SBRA will return a countersigned copy of this application to the rater. The rater shall provide a copy of the approved application to the builder.

Do not write in this space.

SBRA Approval:	 Date:

OMB Control No. xxxx-xxxx

Energy Star Modular Homes	Rev.   DATE \@ "M/d/yyyy"  9/17/2009

EPA Form 5900-191

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 hours and welcomes suggestions for reducing this effort. Send comments (referencing OMB Control Number) to the Director, Collection Strategies Division, U.S. EPA (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460.


[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11227-11228]
[FR Doc No: 2018-05190]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2018-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The date of June 20, 2018 has been established for the FIRM and,
where applicable, the supporting FIS report showing the new or modified
flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov. The flood hazard determinations are
made final in the watersheds and/or communities listed in the table
below.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: February 23, 2018.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Monmouth County, New Jersey (All Jurisdictions)
                         Docket No.: FEMA-B-1471
------------------------------------------------------------------------
Borough of Highlands...................  Municipal Office, 42 Shore
                                          Drive, Highlands, NJ 07732.
Borough of Little Silver...............  Borough Hall, Clerk's Office,
                                          480 Prospect Avenue, Little
                                          Silver, NJ 07739.
Borough of Matawan.....................  Borough Hall, 201 Broad Street,
                                          Matawan, NJ 07747.

Borough of Monmouth Beach..............  Borough Hall, 18 Willow Avenue,
                                          Monmouth Beach, NJ 07750.
------------------------------------------------------------------------
              Ocean County, New Jersey (All Jurisdictions)
                         Docket No.: FEMA-B-1471
------------------------------------------------------------------------
Borough of Point Pleasant Beach........  Municipal Building, 416 New
                                          Jersey Avenue, Point Pleasant
                                          Beach, NJ 08742.
------------------------------------------------------------------------
               Putnam County, Ohio and Incorporated Areas
                Docket Nos.: FEMA-B-1436 and FEMA-B-1704
------------------------------------------------------------------------
Unincorporated Areas of Putnam County..  Putnam County Courthouse, 245
                                          East Main Street, Ottawa, OH
                                          45875.
Village of Cloverdale..................  Village Office, 210 Mahoning
                                          Street, Cloverdale, OH 45827.
Village of Columbus Grove..............  Village Office, 113 East
                                          Sycamore Street, Columbus
                                          Grove, OH 45830.
Village of Dupont......................  Community Center and Village
                                          Hall, 101 Liberty Street,
                                          Dupont, OH 45837.
Village of Fort Jennings...............  Village Office, 440 4th Street,
                                          Fort Jennings, OH 45844.
Village of Gilboa......................  Municipal Building, 206 Main
                                          Street, Gilboa, OH 45875.
Village of Glandorf....................  Village Hall, 201 North Main
                                          Street, Glandorf, OH 45848.
Village of Kalida......................  Municipal Building, 110 South
                                          Broad Street, Kalida, OH
                                          45853.
Village of Leipsic.....................  Village Hall, 142 East Main
                                          Street, Leipsic, OH 45856.
Village of Ottawa......................  Village Hall, 136 North Oak
                                          Street, Ottawa, OH 45875.
Village of Ottoville...................  Municipal Center, 150 Park
                                          Drive, Ottoville, OH 45876.
Village of Pandora.....................  Municipal Building, 102 South
                                          Jefferson Street, Pandora, OH
                                          45877.
------------------------------------------------------------------------
              Clatsop County, Oregon and Incorporated Areas
                         Docket No.: FEMA-B-1703
------------------------------------------------------------------------
City of Cannon Beach...................  City Hall, Community
                                          Development, 163 East Gower
                                          Street, Cannon Beach, OR
                                          97110.
City of Gearhart.......................  City Hall, 698 Pacific Way,
                                          Gearhart, OR 97138.
City of Seaside........................  Community Development, 1387
                                          Avenue U, Seaside, OR 97138.
City of Warrenton......................  City Hall, 225 South Main,
                                          Warrenton, OR 97146.
Unincorporated Areas of Clatsop County.  Community Development, 800
                                          Exchange Street, Suite 100,
                                          Astoria, OR 97103.
------------------------------------------------------------------------
           San Juan County, Washington and Incorporated Areas
                         Docket No.: FEMA-B-1670
------------------------------------------------------------------------
Town of Friday Harbor..................  San Juan Office of Community
                                          Development, 135 Rhone Street,
                                          Friday Harbor, WA 98250.
Unincorporated Areas of San Juan County  San Juan Office of Community
                                          Development, 135 Rhone Street,
                                          Friday Harbor, WA 98250.
------------------------------------------------------------------------

[FR Doc. 2018-05190 Filed 3-13-18; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60504-60505]
[FR Doc No: 2011-25118]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0438] (Formerly 2004D-0027)

Guidance for Industry on Time and Extent Applications for
Nonprescription Drug Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Time and Extent
Applications for Nonprescription Drug Products.'' This guidance
describes a two-step process on how to request that a new condition be
added to the over-the-counter (OTC) drug monograph system. The process
includes submitting a time and extent application (TEA) to determine
whether a condition is eligible for inclusion in the OTC drug monograph
system and, if the condition is found to be eligible, submitting safety
and effectiveness data. This guidance is designed to clarify the TEA
process and what happens after a TEA is submitted. This guidance
finalizes the draft guidance for industry entitled ``Time and Extent
Applications'' published in the Federal Register on February 10, 2004
(69 FR 6309).

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ruth E. Scroggs, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5488, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Time and Extent Applications for Nonprescription Drug
Products.'' This guidance provides information about how to request
that a new condition be added to the OTC drug monograph system. The OTC
drug monograph system was established to evaluate the safety and
effectiveness of all OTC drug products marketed in the United States
before May 11, 1972, that were not marketed under approved new drug
applications (NDAs) and all OTC drug products covered by ``safety''
NDAs that were marketed in the United States before enactment of the
1962 drug amendments to the Federal Food, Drug, and Cosmetic Act (the
FD&C Act). In 1972, FDA began its OTC drug review to evaluate eligible
OTC drug products by categories or classes (e.g., antacids, skin
protectants), rather than on a product-by-product basis, and to develop
``conditions'' under which classes of OTC drug products are generally
recognized as safe and effective (GRASE) and not misbranded.
    FDA publishes these conditions, including active ingredients,
labeling, and other general conditions under which a class of OTC drug
products is considered GRASE, in the Federal Register in the form of
OTC drug monographs. Final monographs are codified in 21 CFR parts 331
through 358. Manufacturers seeking to market an OTC drug product
covered by an OTC drug monograph need not obtain FDA approval before
marketing if their drug product meets the conditions in part 330 (21
CFR part 330) and the applicable final monograph (Sec.  330.1).
    Before Sec.  330.14 went into effect in 2002, there was no formal
process to add OTC drug products that had not been marketed in the
United States before May 11, 1972, to the OTC drug monograph system.
Interested persons were required to obtain premarketing approval under
section 505 of the FD&C Act (21 U.S.C. 355) if they wanted to introduce
into the United States an OTC drug product that had been marketed
solely in a foreign country. Companies also were required to obtain
premarketing approval to market OTC drug products initially marketed in
the United States after the OTC drug review began in 1972.
    In the Federal Register of January 23, 2002 (67 FR 3060), FDA
published a final rule that amended the OTC drug review procedures in
part 330 and included additional criteria and procedures for
classifying OTC drug products as GRASE and not misbranded. The final
rule provided a process for establishing that certain OTC drug
products, which previously required premarketing approval under section
505 of the FD&C Act to be marketed, were eligible to be considered for
inclusion in the OTC drug monograph system. Under the regulation in
Sec.  330.14, an applicant must first submit a TEA to show that the
drug product is eligible for inclusion in the OTC drug monograph system
by showing that the drug product has been marketed ``to a material
extent'' and ``for a material time.'' If FDA determines that the
condition meets the time and extent eligibility criteria, FDA publishes
a notice of eligibility in the Federal Register, and the applicant and
other interested parties have the opportunity to submit safety and
effectiveness data to FDA for evaluation. This two-step process allows
applicants to demonstrate that eligibility criteria are met before
expending resources to prepare safety and effectiveness data.
    In the Federal Register of February 10, 2004, FDA announced the
availability of the draft guidance for industry entitled ``Time and
Extent Applications.'' FDA received comments on the draft guidance,
considered those comments, and revised the guidance as appropriate. The
finalized TEA guidance announced in this document replaces the February
2004 draft guidance. This guidance is designed to clarify the TEA
process. We are providing this guidance because we have received
inquiries from the public regarding the TEA process.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on TEAs. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in Sec.  330.14 have been approved under OMB control number
0910-0688. The collections of information in 21 CFR part 25 and the
guidance for industry entitled ``Environmental Assessment of Human Drug
and Biologics Applications,'' which are referenced in the guidance
announced in this document, are approved under OMB control number 0910-
0322.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25118 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P