37176 Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Proposed Rules

TABLE 2BTOAPPENDIX A OF SUBPART A—DATA ELEMENTS FOR REPORTING EMISSIONS FROM POINT, NONPOINT, ONROAD MOBILE AND NONROAD MOBILE SOURCES, WHERE REQUIRED BY 40 CFR 51.30—Continued

Data elements Point Nonpoint Onroad Nonroad

(18) Percent Control Approach Penetration (where applicable) ...... Y ......

■ 12. Amend § 51.122 by: 1. Federal eRulemaking Portal: Architectural Coatings. In the Rules and ■ a. Revising paragraph (c); www.regulations.gov. Follow the on-line Regulations section of this Federal ■ b. Removing and reserving paragraph instructions. Register, we are approving this local (d); and 2. Email: [email protected]. rule in a direct final action without ■ c. Revising paragraph (f). 3. Mail or deliver: Andrew Steckel prior proposal because we believe this The revisions read as follows: (Air-4), U.S. Environmental Protection SIP revision is not controversial. If we Agency Region IX, 75 Hawthorne Street, receive adverse comments, however, we § 51.122 Emissions reporting San Francisco, CA 94105–3901. will publish a timely withdrawal of the requirements for SIP revisions relating to Instructions: All comments will be budgets for NO emissions. direct final rule and address the X included in the public docket without comments in subsequent action based * * * * * change and may be made available on this proposed rule. Please note that (c) Each revision must provide for online at www.regulations.gov, if we receive adverse comment on an periodic reporting by the state of NOX including any personal information amendment, paragraph, or section of emissions data to demonstrate whether provided, unless the comment includes this rule and if that provision may be the state’s emissions are consistent with Confidential Business Information (CBI) severed from the remainder of the rule, the projections contained in its or other information whose disclosure is we may adopt as final those provisions approved SIP submission. The data restricted by statute. Information that of the rule that are not the subject of an availability requirements in § 51.116 you consider CBI or otherwise protected adverse comment. must be followed for all data submitted should be clearly identified as such and We do not plan to open a second to meet the requirements of paragraph should not be submitted through comment period, so anyone interested (c) of this section. www.regulations.gov or email. in commenting should do so at this * * * * * www.regulations.gov is an ‘‘anonymous time. If we do not receive adverse (f) Reporting schedules. Data access’’ system, and EPA will not know comments, no further activity is collection is to begin during the ozone your identity or contact information planned. For further information, please season 1 year prior to the state’s NOX unless you provide it in the body of see the direct final action. SIP Call compliance date. your comment. If you send email Dated: May 6, 2013. directly to EPA, your email address will [FR Doc. 2013–14628 Filed 6–19–13; 8:45 am] Jared Blumenfeld, BILLING CODE 6560–50–P be automatically captured and included as part of the public comment. If EPA Regional Administrator, Region IX. cannot read your comment due to [FR Doc. 2013–14514 Filed 6–19–13; 8:45 am] ENVIRONMENTAL PROTECTION technical difficulties and cannot contact BILLING CODE 6560–50–P AGENCY you for clarification, EPA may not be able to consider your comment. ENVIRONMENTAL PROTECTION 40 CFR Part 52 Electronic files should avoid the use of AGENCY special characters, any form of [EPA–R09–OAR–2013–0362; FRL–9815–4] encryption, and be free of any defects or 40 CFR Part 372 viruses. Revisions to the California State [EPA–HQ–TRI–2012–0110; FRL–9819–1] Implementation Plan, San Diego Air Docket: Generally, documents in the Pollution Control District docket for this action are available RIN 2025–AA34 electronically at www.regulations.gov AGENCY: Environmental Protection and in hard copy at EPA Region IX, 75 Addition of Nonylphenol Category; Agency (EPA). Hawthorne Street, San Francisco, Community Right-to-Know Toxic ACTION: Proposed rule. California 94105–3901. While all Chemical Release Reporting documents in the docket are listed at AGENCY: Environmental Protection SUMMARY: EPA is proposing to approve www.regulations.gov, some information Agency (EPA). a revision to the San Diego Air Pollution may be publicly available only at the Control District (SDAPCD) portion of hard copy location (e.g., copyrighted ACTION: Proposed rule. the California State Implementation material, large maps), and some may not SUMMARY: EPA is proposing to add a Plan (SIP). This revision concerns be publicly available in either location nonylphenol category to the list of toxic volatile organic compound (VOC) (e.g., CBI). To inspect the hard copy chemicals subject to reporting under emissions from architectural coatings. materials, please schedule an section 313 of the Emergency Planning We are proposing to approve a local rule appointment during normal business and Community Right-to-Know Act to regulate these emission sources under hours with the contact listed in the FOR (EPCRA) of 1986 and section 6607 of the the Clean Air Act (CAA or the Act). FURTHER INFORMATION CONTACT section. Pollution Prevention Act (PPA) of 1990. DATES: Any comments on this proposal FOR FURTHER INFORMATION CONTACT: EPA is proposing to add this chemical must arrive by July 22, 2013. Nicole Law, EPA Region IX, (415) 947– category to the EPCRA section 313 list ADDRESSES: Submit comments, 4126, [email protected]. pursuant to its authority to add identified by docket number EPA–R09– SUPPLEMENTARY INFORMATION: This chemicals and chemical categories OAR–2013–0362, by one of the proposal addresses the following local because EPA believes this category following methods: rule: San Diego APCD Rule 67.0 meets the EPCRA section 313(d)(2)(C)

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toxicity criterion. Based on a review of claimed to be Confidential Business either electronically in the available production and use Information (CBI) or other information www.regulations.gov or in hard copy at information, the members of the whose disclosure is restricted by statute. the OEI Docket, EPA/DC, EPA West, nonylphenol category are expected to be Do not submit information that you Room 3334, 1301 Constitution Ave. manufactured, processed, or otherwise consider to be CBI or otherwise NW., Washington, DC. This Docket used in quantities that would exceed the protected through www.regulations.gov Facility is open from 8:30 a.m. to 4:30 EPCRA section 313 reporting or email. The www.regulations.gov Web p.m., Monday through Friday, excluding thresholds. site is an ‘‘anonymous access’’ system, legal holidays. The telephone number which means EPA will not know your DATES: Comments must be received on for the Public Reading Room is (202) identity or contact information unless or before August 19, 2013. 566–1744, and the telephone number for you provide it in the body of your the OEI Docket is (202) 566–1752. ADDRESSES: Submit your comments, comment. If you send an email identified by Docket ID No. EPA–HQ– comment directly to EPA without going FOR FURTHER INFORMATION CONTACT: TRI–2012–0110, by one of the following through www.regulations.gov, your Daniel R. Bushman, Environmental methods: email address will be automatically Analysis Division, Office of Information • www.regulations.gov: Follow the captured and included as part of the Analysis and Access (2842T), on-line instructions for submitting comment that is placed in the public Environmental Protection Agency, 1200 comments. docket and made available on the Pennsylvania Ave. NW., Washington, • Email: [email protected]. Internet. If you submit an electronic DC 20460; telephone number: 202–566– • Mail: Office of Environmental comment, EPA recommends that you 0743; fax number: 202–566–0677; email: Information (OEI) Docket, include your name and other contact [email protected], for specific Environmental Protection Agency, Mail information in the body of your information on this notice. For general Code: 28221T, 1200 Pennsylvania Ave. comment and with any disk or CD–ROM information on EPCRA section 313, NW., Washington, DC 20460 you submit. If EPA cannot read your contact the Emergency Planning and • Hand Delivery: EPA Docket Center comment due to technical difficulties Community Right-to-Know Hotline, toll (EPA/DC), EPA West, Room 3334, 1301 and cannot contact you for clarification, free at (800) 424–9346 (select menu Constitution Ave. NW., Washington, DC EPA may not be able to consider your option 3) or (703) 412–9810 in Virginia 20460. Such deliveries are only comment. Electronic files should avoid and Alaska or toll free, TDD (800) 553– accepted during the Docket’s normal the use of special characters, avoid any 7672, http://www.epa.gov/superfund/ hours of operation, and special form of encryption, and be free of any contacts/infocenter/. arrangements should be made for defects or viruses. SUPPLEMENTARY INFORMATION: deliveries of boxed information. Docket: All documents in the docket Instructions: Direct your comments to are listed in the www.regulations.gov I. General Information Docket ID No. EPA–HQ–TRI–2012– index. Although listed in the index, A. Does this notice apply to me? 0110. EPA’s policy is that all comments some information is not publicly received will be included in the public available, e.g., CBI or other information You may be potentially affected by docket without change and may be whose disclosure is restricted by statute. this action if you manufacture, process, made available online at Certain other material, such as or otherwise use nonylphenol. www.regulations.gov, including any copyrighted material, will be publicly Potentially affected categories and personal information provided, unless available only in hard copy. Publicly entities may include, but are not limited the comment includes information available docket materials are available 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 pur- pose of generating power for distribution in commerce) (correspond to SIC 4911, 4931, and 4939, Electric Utili- ties); 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 To determine whether your facility listed in the preceding FOR FURTHER exhaustive, but rather provides a guide would be affected by this action, you INFORMATION CONTACT section. for readers regarding entities likely to be should carefully examine the B. How should I submit CBI to the affected by this action. Some of the applicability criteria in part 372 subpart Agency? entities listed in the table have B of Title 40 of the Code of Federal exemptions and/or limitations regarding Regulations. If you have questions Do not submit CBI information to EPA coverage, and other types of entities not regarding the applicability of this action through www.regulations.gov or email. listed in the table could also be affected. to a particular entity, consult the person Clearly mark the part or all of the

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information that you claim to be CBI. (ii) serious or irreversible— on the phenol ring (primarily the ortho For CBI information in a disk or CD– (I) reproductive dysfunctions, (2) and para (4) positions). Nonylphenol ROM that you mail to EPA, mark the (II) neurological disorders, is not a single chemical structure. outside of the disk or CD–ROM as CBI (III) heritable genetic mutations, or Rather it is a complex mixture of highly and then identify electronically within (IV) other chronic health effects. branched nonylphenols, mostly mono- (C) The chemical is known to cause or the disk or CD–ROM the specific substituted in the para position (i.e., the can be reasonably anticipated to cause, information that is claimed as CBI. In 4 position), with small amounts of because of: addition to one complete version of the ortho- and di-substituted nonylphenols. comment that includes information (i) Its toxicity, (ii) its toxicity and persistence in the In addition, nonylphenol can include claimed as CBI, a copy of the comment environment, or small amounts of branched 8 carbon and that does not contain the information (iii) its toxicity and tendency to 10 carbon alkyl groups (Ref. 2). claimed as CBI must be submitted for bioaccumulate in the environment, a inclusion in the public docket. As noted in EPA’s Action Plan for significant adverse effect on the Information so marked will not be nonylphenol (Ref. 1), Chemical Abstract environment of sufficient seriousness, disclosed except in accordance with Service Registry Numbers (CASRNs) in the judgment of the Administrator, to procedures set forth in 40 CFR part 2. that are routinely used for nonylphenols warrant reporting under this section. may not accurately reflect the identity of II. Introduction EPA often refers to the section those substances. Manufacturers may Section 313 of EPCRA, 42 U.S.C. 313(d)(2)(A) criterion as the ‘‘acute incorrectly use a linear identity when 11023, requires certain facilities that human health effects criterion;’’ the actually referring to branched manufacture, process, or otherwise use section 313(d)(2)(B) criterion as the nonylphenol. CASRN 84852–15–3 listed toxic chemicals in amounts above ‘‘chronic human health effects corresponds to the most widely reporting threshold levels to report their criterion;’’ and the section 313(d)(2)(C) produced nonylphenol, branched 4- criterion as the ‘‘environmental effects environmental releases and other waste nonylphenol. Much of the literature management quantities of such criterion.’’ EPA published in the Federal refers to the linear (or normal) chemicals annually. These facilities Register of November 30, 1994 (59 FR nonylphenol (CASRN 25154–52–3) and must also report pollution prevention 61432) a statement clarifying its there are also references to a specific and recycling data for such chemicals, interpretation of the section 313(d)(2) linear para isomer 4-n-nonylphenol pursuant to section 6607 of the PPA, 42 and (d)(3) criteria for modifying the (CASRN 104–40–5), which is covered U.S.C. 13106. Congress established an section 313 list of toxic chemicals. within the broader CASRN 25154–52–3. initial list of toxic chemicals that Many, but not all, references may be comprised more than 300 chemicals and III. Background Information inaccurate about the identity of the 20 chemical categories. A. What is nonylphenol? substances listed as nonylphenol due to EPCRA section 313(d) authorizes EPA inaccurate identities in the source to add or delete chemicals from the list Nonylphenol is an organic chemical material. A supplier of nonylphenol and sets criteria for these actions. whose main use is in the manufacture may use CASRN 104–40–5, signifying EPCRA section 313(d)(2) states that EPA of nonylphenol ethoxylates, which are the linear 4-n-nonylphenol, while may add a chemical to the list if any of nonionic surfactants used in a wide actually supplying branched 4- the listing criteria in Section 313(d)(2) variety of industrial applications and nonylphenol (CASRN 84852–15–3). The are met. Therefore, to add a chemical, consumer products (Reference (Ref.) 1). name 4-nonylphenol is listed as a EPA must demonstrate that at least one Nonylphenol is persistent in the aquatic synonym under CASRN 104–40–5, criterion is met, but need not determine environment, moderately which may lead to such confusion. whether any other criterion is met. The bioaccumulative, and extremely toxic to EPCRA section 313(d)(2) criteria are: aquatic organisms (Ref. 1). Nonylphenol C. How is EPA proposing to list (A) The chemical is known to cause has also been detected in human breast nonylphenol on the TRI? or can reasonably be anticipated to milk, blood, and urine (Ref. 1). cause significant adverse acute human Because there is no one CASRN that B. What is the chemical structure and health effects at concentration levels adequately captures what is referred to identification of nonylphenol? that are reasonably likely to exist as nonylphenol and because of the beyond facility site boundaries as a The chemical structure of apparent confusion that has resulted result of continuous, or frequently nonylphenol consists of a phenol ring from the use of multiple CASRNs, EPA recurring, releases. (benzene with a hydroxyl (OH) group) is proposing to add nonylphenol as a (B) The chemical is known to cause or with a nonyl group (a nine carbon alkyl category defined by a structure. EPA is can reasonably be anticipated to cause chain) attached to the phenol ring. The proposing to define the nonylphenol in humans: nonyl group can either be a branched or category using the structure and text (i) Cancer or teratogenic effects, or linear chain located at various positions presented below.

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This category definition covers the Criteria document for nonylphenol, 5). Reported EC50 values (i.e., the chemicals that are included in CASRNs which was previously peer reviewed concentration that is effective in 84852–15–3 as well as those 4 position (Ref. 3). producing a sublethal response in 50% isomers covered by CASRN 25154–52– A. Acute Toxicity to Aquatic Animals of test organisms) for the water flea 3. Any nonylphenol that meets the (Daphnia magna) ranged from 104 to above category definition would be 1. Freshwater Species. The acute 190 mg/L in renewal and static tests reportable regardless of its assigned toxicity values of nonylphenol to respectively (Refs. 4 and 6). The overall CASRN. freshwater organisms are shown in mean acute value for Daphnia magna Table 1. Acute toxicities have been was 141 mg/L. IV. What Is EPA’s evaluation of the determined for more than 18 species environmental toxicity of nonylphenol? representing over 15 genera. Toxicity Species least sensitive to nonylphenol values ranged from 21 micrograms per were also invertebrates. An annelid Nonylphenol is toxic to aquatic liter (mg/L) for a detritivorous amphipod worm (Lumbriculus variegatus) had an organisms and has been found in (Hyalella aztecta) to 774 mg/L for an LC50 of 342 mg/L, while the acute ambient waters. Because of algal grazing snail (Physella virgata) endpoint for a dragonfly nymph nonylphenol’s toxicity, chemical (Ref. 4). No relationships were found (Ophiogomphus sp.) was an LC50 of 596 properties, and widespread use as a between nonylphenol toxicity and water mg/L (Ref. 4). The least sensitive species chemical intermediate, concerns have hardness or pH. tested was a snail (Physella virgata) with been raised over the potential risks to An amphipod (Hyalella azteca) was an LC50 of 774 mg/L. Eleven species of aquatic organisms from exposure to the most sensitive species tested with fish were tested and found to be in the nonylphenol. All of the hazard LC50 values (i.e., the concentration that mid-range of sensitivity to nonylphenol information presented here has been is lethal to 50% of test organisms) with acute values ranging from 110 to adapted from EPA’s 2005 Water Quality ranging from 21 to 150 mg/L (Refs. 4 and 360 mg/L.

TABLE 1—ACUTE TOXICITY OF NONYLPHENOL TO FRESHWATER ORGANISMS

LC50 or a Species Common name Method pH EC50 Reference (μg/L)

Hyalella azteca (juvenile, 2 mm total length) ...... Amphipod ...... F, M ...... 7.80 21 Ref. 4. Daphnia magna (< 24 hr old) ...... Water Flea ...... R, M ...... 7.87 104 Ref. 4. Etheostoma rubrum (0.062g, 20.2 mm) ...... Fountain Darter ...... S, U ...... 8.0–8.1 110 Ref. 7. Bufo boreas (0.012g, 9.6 mm) ...... Boreal Toad ...... S, U ...... 7.9–8.0 120 Ref. 7. Pimephales promelas (25–35 days old) ...... Fathead Minnow ...... F, M ...... 7.23 128 Ref. 8. Oncorhynchus mykiss (0.27 ± 0.07g) ...... Rainbow Trout ...... S, U ...... 7.9 140 Ref. 9. Oncorhynchus clarki henshawi (0.34 ± 0.08g) ...... Lahontan Cutthroat Trout .. S, U ...... 7.9 140 Ref. 9. Pimephales promelas (32 days old) ...... Fathead Minnow ...... F, M ...... 7.29 140 Refs. 10 and 11. Hyalella azteca (juvenile, 2–3mm total length) ...... Amphipod ...... F, M ...... 7.9–8.7 150 Ref. 5. Oncorhynchus clarki stomais (0.31 ± 0.17g) ...... Greenback Cutthroat Trout S, U ...... 7.5–7.6 150 Ref. 9. Chironomus tentans (2nd instar) ...... Midge ...... F, M ...... 8.0–8.4 160 Ref. 12. Oncorhynchus mykiss (0.48 ± 0.08g) ...... Rainbow Trout ...... S, U ...... 7.5–7.9 160 Ref. 9. Oncorhynchus apache (0.38 ± 0.18g) ...... Apache Trout ...... S, U ...... 7.3–7.7 160 Ref. 9. Xyrauchen texanus (0.31 ± 0.04g) ...... Razorback Sucker ...... S, U ...... 7.8–8.1 160 Ref. 9. Pimephales promelas (0.34 ± 0.24g) ...... Fathead Minnow ...... S, U ...... 7.5–7.6 170 Ref. 9. Oncorhynchus mykiss (0.50 ± 0.21g) ...... Rainbow Trout ...... S, U ...... 6.5–7.9 180 Ref. 9. Oncorhynchus apache (0.85 ± 0.49g) ...... Apache Trout ...... S, U ...... 7.8–7.9 180 Ref. 9. Daphnia magna (< 24 hr old) ...... Water Flea ...... S, M ...... 8.25 190 Ref. 6. Oncorhynchus mykiss (0.67 ± 0.35g) ...... Rainbow Trout ...... S, U ...... 7.8–7.9 190 Ref. 9. Xyrauchen texanus (0.32 ± 0.07g) ...... Razorback Sucker ...... S, U ...... 7.9–8.0 190 Ref. 9. Etheostoma lepidum (0.133g, 22.6 mm) ...... Greenthroat Darter ...... S, U ...... 8.0–8.2 190 Ref. 7. Lepomis macrochirus (juvenile) ...... Bluegill ...... F, M ...... 7.61 209 Ref. 4. Pimephales promelas (0.32 ± 0.16g) ...... Fathead Minnow ...... S, U ...... 7.7–8.1 210 Ref. 9. Oncorhynchus clarki henshawi (0.57 ± 0.23g) ...... Lahontan Cutthroat Trout .. S, U ...... 7.6–7.7 220 Ref. 9. Oncorhynchus mykiss (45 days old) ...... Rainbow Trout ...... F, M ...... 6.72 221 Ref. 4. Poeciliopsis occidentalis (0.22g, 27.2 mm) ...... Gila Topminnow ...... S, U ...... 8.0 230 Ref. 7. Ptychocheilus lucius (0.32 ± 0.05g) ...... Colorado Squawfish ...... S, U ...... 8.1–8.2 240 Ref. 9. Oncorhynchus mykiss (1.25 ± 0.57g) ...... Rainbow Trout ...... S, U ...... 7.5–7.7 260 Ref. 9.

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TABLE 1—ACUTE TOXICITY OF NONYLPHENOL TO FRESHWATER ORGANISMS—Continued

LC50 or a Species Common name Method pH EC50 Reference (μg/L)

Oncorhynchus mykiss (1.09 ± 0.38g) ...... Rainbow Trout ...... S, U ...... 7.7–7.9 270 Ref. 9. Gila elegans (0.29 ± 0.08g) ...... Bonytail Chub ...... S, U ...... 7.7–7.9 270 Ref. 9. Ptychocheilus lucius (0.34 ± 0.05g) ...... Colorado Squawfish ...... S, U ...... 7.8–8.0 270 Ref. 9. Pimephales promelas (0.39 ± 0.14g) ...... Fathead Minnow ...... S, U ...... 7.8–8.2 290 Ref. 9. Pimephales promelas (0.45 ± 0.35g) ...... Fathead Minnow ...... S, U ...... 7.6–7.8 310 Ref. 9. Gila elegans (0.52 ± 0.09g) ...... Bonytail Chub ...... S, U ...... 7.4–7.6 310 Ref. 9. Pimephales promelas (0.40 ± 0.21g) ...... Fathead Minnow ...... S, U ...... 7.5–7.9 330 Ref. 9. Lumbriculus variegatus (adult) ...... Annelid ...... F, M ...... 6.75 342 Ref. 4. Pimephales promelas (0.56 ± 0.19g) ...... Fathead Minnow ...... S, U ...... 7.8–8.1 360 Ref. 9. 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 310 mg/L for the sheepshead minnow (Homarus americanus) with an LC50 of toxicity values of nonylphenol to (Cyprinodon variegatus) (Ref. 14). 71 mg/L (Ref. 13), the mud crab saltwater organisms are shown in Table A number of benthic invertebrates (Dyspanopeus sayii) with an LC50 2. Acute toxicities have been have been investigated including a greater than 195 mg/L (Ref. 13), and two determined for 11 species within 11 deposit-feeding clam (Mulinia lateralis) amphipods (Leptocheirus plumulosus) genera. Acute toxicity values ranged with an LC50 of 38 mg/L (Ref. 13), a with an LC50 of 62 mg/L (Ref. 13) and from 17 mg/L for the winter flounder copepod (Acartia tonsa) with an LC50 of (Eohaustorius estuarius) with an LC50 of (Pleuronectes americanus) (Ref. 13), to 190 mg/L (Ref. 15), the American lobster 138 mg/L (Ref. 16).

TABLE 2—ACUTE TOXICITY OF NONYLPHENOL TO SALTWATER AQUATIC ORGANISMS

LC50 or a Species Common name Method pH EC50 Reference (μg/L)

Pleuronectes americanus (48 hrs old) ...... Winter Flounder ...... S, M ...... 7.8–8.2 17 Ref. 13. Mulinia lateralis (embryo/larvae) ...... Coot Clam ...... S, U ...... 7.8–8.2 38 Ref. 13. Mysidopsis bahia b (< 24 hrs old) ...... Mysid Shrimp ...... F, M ...... 7.3–8.2 43 Ref. 17. Palaemonetes vulgaris (48 hrs old) ...... Grass shrimp ...... F, M ...... 7.8–8.2 59 Ref. 13. Americamysis bahia (< 24 hrs old) ...... Mysid Shrimp ...... F, M ...... 7.8–8.2 61 Ref. 13. Leptocheirus plumosus (adult) ...... Amphipod ...... F, M ...... 7.8–8.2 62 Ref. 13. Menidia beryllina (juvenile) ...... Inland Silversides ...... F, M ...... 7.8–8.2 70 Ref. 13. Homarus americanus (1st stage larvae) ...... American Lobster ...... R, U ...... 7.8–8.2 71 Ref. 13. Eohaustorius estuarius (adult) ...... Amphipod ...... S, U ...... missing 138 Ref. 16. Cyprinodon variegatus (juvenile) ...... Sheepshead Minnow ...... F, M ...... 7.8–8.2 142 Ref. 13. Acartia tonsa (10–12 days old) ...... Copepod ...... S, U ...... missing 190 Ref. 15. Dyspanopeus sayii (4th and 5th stage larvae) ...... Mud Crab ...... F, M ...... 7.8–8.2 > 195 Ref. 13. Cyprinodon variegatus (juvenile) ...... Sheepshead Minnow ...... F, M ...... 7.4–8.1 310 Ref. 14. 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 low as 48 mg/L. Based on this study, a 20 days of exposure. The chronic chronic Lowest-Observed-Effect- toxicity value for survival was 1. Freshwater Species. The chronic Concentration (LOEC) was calculated to calculated as 62 mg/L (Ref. 20). toxicity of nonylphenol to freshwater be 23 mg/L for effects on brood A 91-day life stage test was conducted animals has been studied in two fish production (Ref. 19). Water fleas with the embryos and fry of rainbow and three invertebrate species (Table 3). (Daphnia magna) exposed to 71 and 130 trout (Oncorhynchus mykiss) at Of the invertebrates, a number of mg/L nonylphenol for 21 days exhibited concentrations from 6 to 114 mg/L. species of the cladoceran (water fleas) declines in both growth and adult Nearly all larvae were abnormal at the genus Daphnia have been extensively survival rates (Ref. 6). In a separate 21- two highest exposure concentrations tested for chronic effects. Water flea day life cycle study of water fleas (≥ 53 mg/L) (Ref. 4). Survival was (Ceriodaphnia dubia) neonates (Daphnia magna); growth, reproduction, reduced at ≥ 23 mg/L and growth exhibited reproductive impairment and survival were all reduced at measured as both change in weight and when exposed to nonylphenol for 7 concentrations of 158 mg/L and above length was even more sensitive with days at 202 mg/L and survival was (Ref. 4). measured decreases at concentrations as impaired at concentrations of 377 mg/L Less than 24-hour-old midge low as 10 mg/L. The chronic toxicity (Ref. 18). Four to 24-hour old water fleas (Chironomus tentans) larvae exposed to effect value for growth (both weight and (Daphnia magna) showed a reduction in concentrations of nonylphenol from 12 length) was calculated as 8 mg/L (Ref. 4). the number of young per brood over 9 to 200 mg/L and showed significant Embryos and larvae of the fathead days of exposure to concentrations as declines in larval survival over the first minnow (Pimephales promelas) were

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exposed in a 33-day early-life-stage test 22). The first experiment was a 28-day growth (Ref. 23). Growth of female at nonylphenol concentrations ranging exposure measuring survival, growth, mysids (Americamysis bahia) was from 3 to 23 mg/L (Ref. 21). Hatching and reproduction. Shrimp survival was reduced at concentrations at and above was delayed at the two highest reduced by 18% on exposure to 9 mg/L. 28 mg/L. Brood production was the most concentrations (14 and 23 mg/L). Growth in length was the most sensitive sensitive endpoint in this study. The Fathead minnow survival was reduced endpoint with a 7% reduction in length average number of young per female- at concentrations of 14 mg/L and greater. for animals exposed to 7 mg/L and No- reproductive day was reduced at The survival chronic toxicity effect Observed-Effect-Concentration (NOEC) concentrations ≥ 15 mg/L. The NOECs value for fathead minnows was and LOEC for growth responses of 4 and and LOECs for reproductive responses calculated to be 14 mg/L (Ref. 21). 7 mg/L (Table 3). were 9 and 15 mg/L. 2. Saltwater Species. Two chronic The second experiment, a 28-day life- toxicity tests have been conducted with cycle test, examined the effect of mysid shrimp (Mysidopsis bahia) (Ref. nonylphenol on brood release and

TABLE 3—CHRONIC TOXICITY OF NONYLPHENOL TO AQUATIC ORGANISMS [Freshwater and Saltwater]

Chronic ab value Species Common name Method pH range Endpoint Reference (μg/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 Total Ref. 23. Number of Young. Pimephales promelas ...... Fathead Minnow ...... ELS, FW .. 7.1–8.2 14 Delayed Hatching; Sur- Ref. 21. vival. 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 Total Ref. 19. 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 d Ref. 20. 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 Reproduc- tion; Survival. Ceriodaphnia dubia ...... Water Flea ...... LC, FW .... 8.3–8.6 202 Reproductive Impairment Ref. 18. 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 D. Bioaccumulation (Ref. 27). Overall, lipid-normalized BCF’s for fathead minnows in 4- and 27- 1. Freshwater. Ecological toxicity data 1. Freshwater Species. Data on day tests ranged from 128 to 209 and for for freshwater plants was available only bioaccumulation of nonylphenol in bluegills from 39 to 57 (Ref. 8). A 42-day for single-celled planktonic green alga freshwater organisms was limited to two exposure experiment using fathead (Selenastrum capricornutum) (Ref. 24). species of fish, fathead minnow minnows and exposure concentrations Algae exposed to nonylphenol for 4 (Pimephales promelas) and bluegill of 0.4 to 3.4 mg/L resulted in BCFs days had an EC50 for effect on (Lepomis macrochirus). Juvenile fathead ranging from 203 to 268 (Ref. 28). population growth rate of 410 mg/L. The minnows exposed to 5 and 23 mg/L 2. Saltwater Species. Bioconcentration effect did not persist when the algae nonylphenol for 27 days showed non- factors are available for three species of were transferred to fresh, lipid-normalized bioconcentration marine animals; the blue mussel uncontaminated, growth medium. factors (BCF) of 271 and 344 (Mytilus edulis), the three-spined 2. Saltwater. Ecological toxicity data respectively (Ref. 26). Values which had stickleback fish (Gasterosteus for saltwater plants are available only been normalized to organism lipid aculeatus), and a benthic shrimp for a single species of marine planktonic content were approximately five times (Crangon crangon) (Ref. 29). Individuals algae, a diatom (Skeletonema costatum) lower. A short-term (4-day) bioassay of all three species were exposed to 14 (Ref. 25). The EC50 for nonylphenol indicated that tissue concentrations carbon-14 ( C)-labeled nonylphenol for effect on vegetative growth was 27 reached steady-state within two days in 16 days and followed over a subsequent mg/L. both the fathead minnow and bluegill elimination period of 32 days. BCFs

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ranged from a measured value in swordfish (Xiphophorous helleri). In observed at 18 mg/L with 20% of the fish benthic shrimp of 79 to an estimated contrast, additional studies did not exhibiting external male characteristics value of 2,168 for the blue mussel. show vitellogenin induction in rainbow having ovo-testis. At 51 mg/L, all fish trout exposed for 9 days at 109 mg/L exhibited external female characteristics E. Reproductive, Developmental, and (Ref. 43) or the Atlantic salmon (Salmo with 40% containing ovo-testis. Estrogenic Effects trutta) exposed for 30 days to 20 mg/L Spermatogenesis was observed in ovo- Numerous investigations have (Ref. 44). testis containing fish exposed to 18 but demonstrated the estrogenic activity of Vitellogenin messenger ribonucleic not 51 mg/L. Fecundity was not affected nonylphenol (see Refs. 30, 31, and 32 acid (mRNA) is a direct precursor to by nonylphenol exposure. GSI of female for reviews). The majority of studies protein formation and increased fish was increased by exposure to have been conducted with aquatic production in rainbow trout at concentrations greater than 8 mg/L. species and effects have been concentrations of 10 to 14 mg/L when Effects of exposure on the F1 demonstrated both in vitro and in vivo. exposed for 4 and 72 hours respectively generation were also reported with no While most of these studies have been (Ref. 3). Increased levels of plasma embryological abnormalities or hatching conducted on fish, a number of species vitellogenin and several pituitary and failures observed at any of the treatment of invertebrates have also been plasma hormone levels were observed concentrations. Growth was also not examined. in female rainbow trout exposed to 8 affected at 60 days post-hatch in the F1 1. Aquatic Invertebrates. Among and 86 mg/L nonylphenol. The route of generation. However, the sex ratio as invertebrates, estrogenic effects have exposure influenced vitellogenin determined by secondary sexual been demonstrated in a marine induction in the fathead minnow with characteristics changed in favor of amphipod (Corophium volutator) at 10 an order of magnitude greater induction females (1:2) at concentrations greater mg/L (Ref. 33) and larvae of a freshwater when exposed via water as opposed to than 18 mg/L. Induction of ovo-testis insect (Chironomus riparis) at 2,000 mg/ diet (Ref. 45). occurred at lower concentrations in the L (Ref. 34). However, no estrogenic Fish fecundity (i.e., the rate of F1 as opposed to the F0 generation (8 effects were found in a marine copepod production of young) is also affected in versus 18 mg/L). All fish in the F1 (Tisbe battagliai) at exposure various ways by nonylphenol exposure generation with ovo-testis displayed concentrations up to 55 mg/L (Ref. 35). (Ref. 28). Concentrations as low as 0.5 external male characteristics and the 2. In Vivo Responses in Fish. The to 3.4 mg/L, although not acutely toxic, degree of oocyte development was not protein vitellogenin, which is produced decreased the fecundity of fathead as complete as with the F0 18 mg/L in the liver, is a primary constituent in minnows at various times over the treatment. The overall results suggest a the yolk of the ova of oviparous reproductive season. At concentrations NOEC and LOEC of approximately 8 vertebrate species (i.e., species of approximately 0.1 mg/L, fecundity and 18 mg/L respectively. producing eggs which hatch outside the was increased in fathead minnows. A multi-generational study has also body). Very little vitellogenin is These results suggest a possible been conducted for the rainbow trout produced in males and increased hormetic response of fish fecundity to (Oncorhynchus mykiss) (Ref. 50). vitellogenin production in males is an nonylphenol. Exposure to concentrations of 1 and 10 indication of estrogenic effects. While A number of studies have been mg/L of adult males and females was nonylphenol has been shown to performed with the fish Japanese intermittent over 4 months. Vitellogenin produce estrogenic effects, estimates medaka (Oryzias latipes). Following induction was increased in adult male from studies on male rainbow trout hatch, a cohort of Japanese medaka was fish exposed to both 1 and 10 mg/L. Male (Oncorhynchus mykiss) suggest that it is exposed for 28 days and monitored for progeny of fish exposed to 10 mg/L 2,000 to 3,000 times less potent than the following 55 days for survival, showed elevated plasma estradiol natural estrogen (17 beta-estradiol) (Ref. growth, egg viability, egg production, concentrations. Female progeny showed 36). and gonosomatic index (GSI) (Ref. 46). elevated levels of plasma testosterone Exposure to nonylphenol has been No effects were noted at the lowest and vitellogenin concentrations. shown to increase vitellogenin exposure concentration of 1.93 mg/L. production in male rainbow trout However, in a 3-month exposure study V. Rationale for Listing (Oncorhynchus mykiss) at with the same species, effects were EPA’s technical evaluation of concentrations from 10 to 100 mg/L over noted at 50 mg/L and included intersex nonylphenol shows that it can periods of 4 hours to 3 days (Refs. 37, (development of ovo-testis) and the sex reasonably be anticipated to cause, 38 and 39). Jobling and colleagues (Ref. ratio shifted in favor of females (Ref. because of its toxicity, significant 40) also found increased vitellogenin 47). Another study of Japanese medaka adverse effects in aquatic organisms. production in male rainbow trout after found that, in fish exposed from Toxicity values for nonylphenol are 21 days of exposure to nonylphenol fertilized egg to 60 days post-hatch, the available for numerous species of concentrations of 20 and 54 mg/L. LOEC for vitellogenin induction was aquatic organisms. The observed effects Similarly, Tremblay and van der Kraak found to be 12 mg/L (Ref. 48). from nonylphenol exposure occur at (Ref. 41) found increased plasma A two-generation (F0 and F1) flow- very low concentrations demonstrating vitellogenin after 3 weeks of exposure to through study exposed Japanese medaka that nonylphenol is highly toxic to 50 mg/L nonylphenol in rainbow trout. from eggs to 60 days post-hatch of the aquatic organisms. Data summarized in Female rainbow trout are similarly second (F1) generation at concentrations this document include acute toxicity sensitive with vitellogenin induction ranging from 4 to 183 mg/L (Ref. 49). For values for freshwater organisms ranging occurring with exposures ranging from the F0 generation, egg hatchability was from 21 mg/L for a detritivorous 8 to 86 mg/L (Ref. 42). The study on reduced by 48% at 187 mg/L. Survival amphipod to 774 mg/L for an algal female rainbow trout also noted that was reduced at 60 days post-hatch for grazing snail. Acute toxicity values for nonylphenol exposure caused changes exposures at or above 18 mg/L. However, freshwater fish ranged from 110 mg/L for in several pituitary and hormone plasma no differences in growth rates were the fountain darter to 128 to 360 mg/L levels. Exposure to nonylphenol observed in the F0 generation at any for the fathead minnow. Acute toxicity concentrations as low as 4 mg/L led to exposure concentration 60 days post- values for saltwater organisms ranged vitellogenin induction in male green hatch. Induction of ovo-testis was from 17 mg/L for the winter flounder to

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310 mg/L for the sheepshead minnow. United States Environmental Protection Number 8972–CMA, Hampton, NH. 34 Chronic toxicity values are also Agency, Washington, DC. Office of pp. available for several aquatic species Water. EPA–822–R–05–005. December 15. Kusk, K.O. and L. Wollenberger. 1999. ranging from 5 mg/L for growth effects in 2005. Fully defined saltwater medium for 4. Brooke, L.T. 1993a. Acute and chronic cultivation of and toxicity testing with mysid shrimp to 377 mg/L for survival toxicity of nonylphenol to ten species of the marine copepod Acartia tonsa. effects in water fleas. Chronic toxicity aquatic organisms. Report to the U.S. Environ. Toxicol. Chem. 20: 1564–1567. values for rainbow trout ranged from 8 EPA for Work Assignment No. 02 of 16. Hecht, S. and B.L. Boese. 2002. mg/L for effects on growth to 53 mg/L for Contract No. 68–C1–0034. Lake Superior Sensitivity of an infaunal amphipod, abnormal development. Reproductive, Research Institute, University of Eohaustorius estuaries, to acute developmental, and estrogenic effects Wisconsin-Superior, Superior, WI. waterborne exposures of 4-nonylphenol: on aquatic organisms have also been March 24. 30 pp. Amended 18 October Evidence of a toxic hangover. Environ. Toxicol. Chem. 21: 816–819. reported for nonylphenol with some 2005. 34 pp. 5. England, D.E. and J.B. Bussard. 1995. 17. Ward, T.J. and R.L. Boeri. 1990b. Acute effects observed at concentrations of 4 Toxicity of nonylphenol to the flow through toxicity of nonylphenol to mg/L or less. Therefore, EPA believes amphipod Hyalella azteca (Saussure). the mysid, Mysidopsis bahia. that the evidence is sufficient for listing Report No. 41569. ABC Laboratories, EnviroSystems Study Number 8974– the nonylphenol category on the EPCRA Inc., Columbia, MO. 178 pp. CMA, Hampton, NH. 35 pp. section 313 toxic chemical list pursuant 6. Comber, M.H.I., T.D. Williams and K.M. 18. England, D.E. 1995. Chronic toxicity of to EPCRA section 313(d)(2)(C) based on Stewart. 1993. The effects of nonylphenol to Ceriodaphnia dubia. nonylphenol on Daphnia magna. Wat. Report No. 41756. ABC Laboratories, Inc. the available ecological toxicity data. Columbia, MO. 409 pp. EPA does not believe that it is Res. 27: 273–276. 7. Dwyer, F.J., D.K. Hardesty, C.E. Henke, 19. Fliedner, A. 1993. Daphnia magna appropriate to consider exposure for C.G. Ingersoll, D.W. Whites, D.R. Mount Reproduction test (OECD) No. 202). chemicals that are highly toxic based on and C.M. Bridges. 1999. Assessing Fraunhofer-Institute fur Umweltchemie a hazard assessment when determining contaminant sensitivity of endangered und Okotoxikologie, Posfach 1260, W– if a chemical can be added for and threatened species: Toxicant classes. 5948 Schmallenberg—Grafschaft, environmental effects pursuant to EPA/600/R–99/098. National Technical Germany. Report No. UBA–002/4–22 Information Service, Springfield, VA. February. EPCRA section 313(d)(2)(C) (see 59 FR 20. Kahl, M.D., E.A. Makynen, P.A. Kosian 61440–61442). Therefore, in accordance 15pp. 8. Brooke, L.T. 1993b. Nonylphenol Toxicity. and G.T. Ankley. 1997. Toxicity of 4- with EPA’s standard policy on the use nonylphenol in a life-cycle test with the Accumulation and lethality for two of exposure assessments (59 FR 61432), midge Chironomus tentans. Ecotoxicol. freshwater fishes (fathead minnow and Environ. Saf. 38: 155–160. EPA does not believe that an exposure bluegill) to nonylphenol. Report to the 21. Ward, T.J. and R.L. Boeri. 1991a. Early assessment is necessary or appropriate U.S. EPA for the Work Assignment No. life stage toxicity of nonylphenol to the for determining whether the 1–12 of Contract No. 68–C1–0034. Lake nonylphenol category meets the criteria fathead minnow, Pimephales promelas. Superior Research Institute, University EnviroSystems Study Number 8979– of EPCRA section 313(d)(2)(C). of Wisconsin-Superior, WI. September CMA, Hampton, NH. 59 pp. 30. 50 pp. VI. References 22. Ward, T.J. and R.L. Boeri. 1991b. Chronic 9. Dwyer, F.J., L.C. Sappington, D.R. Buckler toxicity of nonylphenol to the mysid, EPA has established an official public and S.B. Jones. 1995. Use of surrogate Mysidopsis bahia. EnviroSystems Study docket for this action under Docket ID species in assessing contaminant risk to Number 8977–CMA, Hampton, NH. 61 No. EPA–HQ–TRI–2012–0110. The endangered and threatened fishes. EPA/ pp. 600/R–96/029. National Technical public docket includes information 23. Kuhn, A., W.R. Munns, Jr., D. Champlin, Information Service, Springfield, VA. 71 R. McKinney, M. Tagliabue, J. Serbst and considered by EPA in developing this pp. action, including the documents listed T. Gleason. 2001. Evaluation of the 10. Holcombe, G.W., G.L. Phipps, M.L. Knuth efficacy of extrapolation population below, which are electronically or and T. Felhaber. 1984. The acute toxicity modeling to predict the dynamics of physically located in the docket. In of selected substituted phenols, Americamysis bahia populations in the addition, interested parties should benzenes, and benzoic acid esters to laboratory. Environ. Toxicol. Chem. 20: consult documents that are referenced fathead minnows (Pimephales 213–221. in the documents that EPA has placed promelas). Environ. Pollut. (Series A) 35: 24. Ward, T.J. and R.L. Boeri. 1990c. Acute in the docket, regardless of whether 367–381. static toxicity of nonylphenol to the 11. University of Wisconsin-Superior. 1985. freshwater alga Selenastrum these referenced documents are Acute toxicities of organic chemicals to electronically or physically located in capricornutum. EnviroSystems Study fathead minnows (Pimephales Number 8969–CMA, Hampton, NH. 41 the docket. For assistance in locating promelas). Volume II. D.L. Geiger, C.E. pp. documents that are referenced in Northcott, D.J. Call, and L.T. Brooke 25. Ward, T.J. and R.L. Boeri. 1990d. Acute documents that EPA has placed in the (Eds.). Center for Lake Superior static toxicity of nonylphenol to the docket, but that are not electronically or Environmental Studies, University of marine alga Skeletonema costatum. physically located in the docket, please Wisconsin-Superior, Superior, WI. 326 EnviroSystems Study Number 8970– consult the person listed in the above pp. CMA, Hampton, NH. 42 pp. 12. England, D.E. and J.B. Bussard. 1993. FOR FURTHER INFORMATION CONTACT 26. Ward, T.J. and R.L. Boeri. 1991c. Toxicity of nonylphenol to the midge section. Bioconcentration test with nonlylphenol Chironomus tentans. Report No. 40597. and the Fathead Minnow, Pimephales 1. USEPA. 2010. Nonylphenol (NP) and ABC Laboratories, Inc., Columbia, MO. promelas. EnviroSystems Study Number Nonylphenol Ethoxylates (NPEs) Action 92 pp. 8975–CMA, Hampton, NH. 72 pp. Plan (RIN 2070–ZA09). United States 13. Lussier, S.M., D. Champlin, J. LiVolsi, S. 27. Brooke, L.T. 1994. Nonylphenol Analysis. Environmental Protection Agency, Poucher and R.J. Pruell. 2000. Acute Accumulation and lethality for two Washington, DC. August 18, 2010. toxicity of para-nonylphenol to saltwater freshwater fishes (fathead minnow and 2. Lorenc, J. F., Lambeth, G. and Scheffer, W. animals. Environ. Toxicol. Chem. 19: bluegill) to nonylphenol. Report to the 2003. Alkylphenols. Kirk-Othmer 617–621. U.S. EPA for the Work Assignment No. Encyclopedia of Chemical Technology, 14. Ward, T.J. and R.L. Boeri. 1990a. Acute 2–15 of Contract No. 68–C1–0034. Lake John Wiley & Sons, Inc. 2:225. flow through toxicity of nonylphenol to Superior Research Institute, University 3. USEPA. 2005. Aquatic Life Ambient Water the sheepshead minnow, Cyprinodon of Wisconsin-Superior, WI. May 31. 49 Quality Criteria—Nonylphenol Final. variegatus. EnviroSystems Study pp.

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28. Giesy, J.P., S.L. Pierens, E.M. Snyder, S. Sumpter. 2001. Nonylphenol affects B. Paperwork Reduction Act Miles-Richardson, V.J. Kramer, S.A. gonadotropin levels in the pituitary This proposed rule does not contain Snyder, K.M. Nichols, and D.A. gland and plasma of female rainbow Villeneuve. 2000. Effects of 4- trout. Environ. Sci. Technol. 35: 2909– any new information collection nonylphenol on fecundity of biomarkers 2916. requirements that require additional of estrogenicity in fathead minnows 43. Pedersen, S.N. L.B. Christiansen, K.L. approval by the Office of Management (Pimephales promelas). Environ. Pedersen, B. Korsgaard, and P. and Budget (OMB) under the Paperwork Toxicol. Chem. 19: 1368–1377. Bjerregaard. 1999. In vivo estrogenic Reduction Act (PRA), 44 U.S.C. 3501 et. 29. Ekelund, R., A. Bergman, A. Granmo, and activity of branched and linear seq. Currently, the facilities subject to M. Berggren. 1990. Bioaccumulation of alkylphenols in rainbow trout the reporting requirements under 4-nonylphenol in marine animals—A re- evaluation. Environ. Poll. 64: 107–120. (Oncorhychus mykiss). Sci. Tot. Environ. EPCRA 313 and PPA 6607 may use 30. Servos, M.R. 1999. Review of the aquatic 233: 89–96. either the EPA Toxic Chemicals Release toxicity, estrogenic responses, and 44. Moore, A., A.P. Scott, N. Lower, I. Inventory Form R (EPA Form 9350–1), bioaccumulation of alkylphenols and Katsiadaki, and L. Greenwood. 2003. The or the EPA Toxic Chemicals Release alkylphenol polyethoxylates. Wat. Qual. effects of 4-nonylphenol and atrazine on Inventory Form A (EPA Form 9350–2). Res. J. Can. 34: 123–177. Atlantic salmon (Salmo salar L.) smolts. The Form R must be completed if a 31. Sonnenschein, C. and A.M. Soto. 1998. Aquaculture 222: 253–263. facility manufactures, processes, or An updated review of environmental 45. Pickford, K.A., R.E. Thomas-Jones, B. otherwise uses any listed chemical estrogen and androgen mimics and Wheals, C.R. Tyler, and J.P. Sumpter. antagonists. J. Steroid Biochem. Molec. 2003. Route of exposure affects the above threshold quantities and meets Biol. 65: 143–150. oestrogenic response of fish to 4-tert- certain other criteria. For the Form A, 32. Sumpter, J.P. 1998. Xenoendocrine nonylphenol. Aquat. Toxicol. 65: 267– EPA established an alternative threshold disrupters—environmental impacts. 279. for facilities with low annual reportable Toxicol. Lett. 102–103: 337–342. 46. Nimrod, A.C. and W.H. Benson. 1998. amounts of a listed toxic chemical. A 33. Brown, R.J., M. Conradi, and M.H. Reproduction and development of facility that meets the appropriate Depledge. 1999. Long-term exposure to Japanese medaka following an early life reporting thresholds, but estimates that 4-nonylphenol affects sexual stage exposure to xenoestrogens. Aquat. the total annual reportable amount of differentiation and growth of the Toxicol. 44: 141–156. the chemical does not exceed 500 amphipod Corophium volutator (Pallus, 47. Gray, M.A. and C.D. Metcalfe. 1997. 1766). Sci. Total Environ. 233: 77–88. pounds per year, can take advantage of Induction of testis-ova in Japanese 34. Hahn, T., K. Schenk, and R. Schulz. 2002. an alternative manufacture, process, or medaka (Oryzias latipes) exposed to p- Environmental chemicals with known otherwise use threshold of 1 million endocrine potential affect yolk protein nonylphenol. Environ. Toxicol. Chem. pounds per year of the chemical, content in the aquatic insect Chironomus 16: 1082–1086. provided that certain conditions are riparius. Environ. Pollut. 120: 525–528. 48. Seki, M., H. Yokota, M. Maeda, H. met, and submit the Form A instead of 35. Bechmann, R.K. 1999. Effect of the Tadokoro, and K. Kobayashi. 2003. the Form R. In addition, respondents endocrine disruptor nonylphenol on the Effects of 4-nonylphenol and 4-tert- octylphenol on sex differentiation and may designate the specific chemical marine copepod Tisbe battagliai. Sci. identity of a substance as a trade secret Total Environ. 233: 33–46. vitellogenin induction in medaka 36. Islinger, M., S. Pawlowski, H. Hollert, A. (Oryzias latipes). Environ. Toxicol. pursuant to EPCRA section 322 42 Volkl, and T. Braumbeck. 1999. Chem. 22: 1507–1516. U.S.C. 11042: 40 CFR part 350. Measurement of vitellogenin-mRNA 49. Yokota, H., M. Seki, M. Maeda, Y. OMB has approved the reporting and expression in primary cultures of Oshima, H. Tadokoro, T. Honjo, and K. recordkeeping requirements related to rainbow trout hepatocytes in a non- Kobayashi. 2001. Life-cycle toxicity of 4- Forms A and R, supplier notification, radioactive dot blot/RNAse protection- nonylphenol to medaka (Oryzias latipes). and petitions under OMB Control assay. Sci. Total Environ. 233:109–122. Environ. Toxicol. Chem. 20: 2552–2560. number 2025–0009 (EPA Information 37. Ren, L., D. Lattier, and J.J. Lech. 1996a. 50. Schwaiger, J., U. Mallow, H. Ferling, S. Collection Request (ICR) No. 1363) and Estrogenic activity in rainbow trout Knoerr, T. Braunbeck, W. Kalbfus, and those related to trade secret designations determined with a new cDNA probe for R.D. Negele. 2000. How estrogenic is under OMB Control 2050–0078 (EPA vitellogenesis, pSG5Vg1.1. Bull. Environ. nonylphenol? A transgenerational study Contam. Toxicol. 56: 287–294. ICR No. 1428). As provided in 5 CFR using rainbow trout (Oncorhynchus 1320.5(b) and 1320.6(a), an Agency may 38. Ren, L., S.K. Lewis, and J.J. Lech. 1996b. mykiss) as a test organism. Aquat. not conduct or sponsor, and a person is Effects of estrogen and nonylphenol on Toxicol. 59: 177–189. the post-transcriptional regulation of 51. USEPA, OEI. Economic Analysis of the not required to respond to, a collection vitellogenin gene expression. Chemico- Proposed Rule to add Nonylphenol to of information unless it displays a Biol. Interact. 100: 67–76. the EPCRA Section 313 List of Toxic currently valid OMB control number. 39. Lech, J.J., S.K. Lewis, and L. Ren. 1996. Chemicals. June 11, 2013. The OMB control numbers relevant to In vivo estrogenic activity of EPA’s regulations are listed in 40 CFR nonylphenol in rainbow trout. Fund. VII. What are the Statutory and part 9, 48 CFR chapter 15, and Appl. Toxicol. 30: 229–232. Executive Order Reviews associated displayed on the information collection 40. Jobling, S., D. Sheahan, J.A. Osborne, P. with this action? Matthiessen, and J.P. Sumpter. 1996. instruments (e.g., forms, instructions). Inhibition of testicular growth in A. Executive Order 12866: Regulatory For the 57 Form Rs and 13 Form As rainbow trout (Oncorhynchus mykiss) Planning and Review and Executive expected to be filed, EPA estimates the exposed to estrogenic alkylphenolic Order 13563: Improving Regulation and industry reporting and recordkeeping chemicals. Environ. Toxicol. Chem. 15: Regulatory Review burden for collecting this information to 194–202. average, in the first year, $246,429 41. Tremblay, L. and G. van der Kraak. 1998. This action is not a ‘‘significant (based on 4,874 total burden hours) (Ref. Use of a series of homologous in vitro regulatory action’’ under the terms of 51). In subsequent years, the burden for and in vivo assays to evaluate the endocrine modulating actions of beta- Executive Order 12866 (58 FR 51735, collecting this information is estimated sitosterol in rainbow trout. Aquat. October 4, 1993) and is therefore not to average $117,350 (based on 2,321 Toxicol. 43: 149–162. subject to review under Executive total burden hours). These estimates 42. Harris, C.A., E.M. Santos, a. Janbakhsh, Orders 12866 and 13563 (76 FR 3821, include the time needed to become T.G. Pottinger, C.R. Tyler, and J.P. January 21, 2011). familiar with the requirement (first-year

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only); review instructions; search affected by this action. Thus this rule is 13175, and consistent with EPA policy existing data sources; gather and not expected to have a significant to promote communications between maintain the data needed; complete and adverse economic impact on a EPA and Indian Tribal Governments, review the collection information; and substantial number of small entities. A EPA specifically solicits additional transmit or otherwise disclose the more detailed analysis of the impacts on comment on this proposed action from information. The actual burden on any small entities is located in EPA’s tribal officials. facility may be different from this economic analysis support document G. Executive Order 13045: Protection of estimate depending on the complexity (Ref. 51). We continue to be interested Children From Environmental Health of the facility’s operations and the in the potential impacts of the proposed Risks and Safety Risks profile of the releases at the facility. rule on small entities and welcome Upon promulgation of a final rule, the comments on issues related to such EPA interprets EO 13045 (62 FR Agency may determine that the existing impacts. 19885, April 23, 1997) as applying only burden estimates in the ICRs need to be to those regulatory actions that concern amended in order to account for an D. Unfunded Mandates Reform Act health or safety risks, such that the increase in burden associated with the This rule does not contain a Federal analysis required under section 5–501 of final action. If so, the Agency will mandate that may result in expenditures the EO has the potential to influence the submit an information collection of $100 million or more for State, local, regulation. This action is not subject to worksheet (ICW) to OMB requesting that and tribal governments, in the aggregate, EO 13045 because it does not establish the total burden in each ICR be or the private sector in any one year. an environmental standard intended to amended, as appropriate. EPA’s economic analysis indicates that mitigate health or safety risks. the total cost of this rule is estimated to C. Regulatory Flexibility Act (RFA), as be $246,722 in the first year of H. Executive Order 13211: Actions Amended by the Small Business reporting. Thus, this rule is not subject Concerning Regulations That Regulatory Enforcement Fairness Act of to the requirements of sections 202 or Significantly Affect Energy Supply, 1996 (SBREFA), 5 U.S.C. 601 et seq. 205 of UMRA. Distribution, or Use The RFA generally requires an agency This rule is also not subject to the This action is not subject to Executive to prepare a regulatory flexibility requirements of section 203 of UMRA Order 13211 (66 FR 28355 (May 22, analysis of any rule subject to notice because it contains no regulatory 2001)), because it is not a significant and comment rulemaking requirements requirements that might significantly or regulatory action under Executive Order under the Administrative Procedure Act uniquely affect small governments. 12866. or any other statute unless the agency Small governments are not subject to the I. National Technology Transfer and certifies that the rule will not have a EPCRA section 313 reporting Advancement Act significant economic impact on a requirements. substantial number of small entities. Section 12(d) of the National Small entities include small businesses, E. Executive Order 13132 (Federalism) Technology Transfer and Advancement small organizations, and small This action does not have federalism Act of 1995 (‘‘NTTAA’’), Public Law governmental jurisdictions. For implications. It will not have substantial 104–113, 12(d) (15 U.S.C. 272 note) purposes of assessing the impacts of direct effects on the States, on the directs EPA to use voluntary consensus today’s rule on small entities, small relationship between the national standards in its regulatory activities entity is defined as: (1) A business that government and the States, or on the unless to do so would be inconsistent is classified as a ‘‘small business’’ by the distribution of power and with applicable law or otherwise Small Business Administration at 13 responsibilities among the various impractical. Voluntary consensus CFR 121.201; (2) a small governmental levels of government, as specified in standards are technical standards (e.g., jurisdiction that is a government of a Executive Order 13132. This action materials specifications, test methods, city, county, town, school district or relates to toxic chemical reporting under sampling procedures, and business special district with a population of less EPCRA section 313, which primarily practices) that are developed or adopted than 50,000; and (3) a small affects private sector facilities. Thus, by voluntary consensus standards organization that is any not-for-profit Executive Order 13132 does not apply bodies. NTTAA directs EPA to provide enterprise which is independently to this action. Congress, through OMB, explanations owned and operated and is not In the spirit of Executive Order 13132, when the Agency decides not to use dominant in its field. and consistent with EPA policy to available and applicable voluntary After considering the economic promote communications between EPA consensus standards. impacts of today’s rule on small entities, and State and local governments, EPA This proposed rulemaking does not I certify that this action will not have a specifically solicits comment on this involve technical standards. Therefore, significant economic impact on a proposed action from State and local EPA is not considering the use of any substantial number of small entities. Of officials. voluntary consensus standards. the 70 entities estimated to be impacted by this proposed rule, 34 are small F. Executive Order 13175: Consultation J. Executive Order 12898: Federal businesses. Of the affected small and Coordination With Indian Tribal Actions To Address Environmental businesses, all 34 are projected to have Governments Justice in Minority Populations and cost-to-revenue impacts of less than 1% This action does not have tribal Low-Income Populations in both the first and subsequent years of implications, as specified in Executive Executive Order (EO) 12898 (59 FR the rulemaking. Facilities eligible to use Order 13175 (65 FR 67249, November 9, 7629 (Feb. 16, 1994)) establishes Federal Form A (those meeting the appropriate 2000). This action relates to toxic executive policy on environmental activity threshold which have 500 chemical reporting under EPCRA justice. Its main provision directs pounds per year or less of reportable section 313, which primarily affects Federal agencies, to the greatest extent amounts of the chemical) will have a private sector facilities. Thus, Executive practicable and permitted by law, to lower burden. No small governments or Order 13175 does not apply to this make environmental justice part of their small organizations are expected to be action. In the spirit of Executive Order mission by identifying and addressing,

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as appropriate, disproportionately high populations) with access to data which Dated: June 14, 2013. and adverse human health or they may use to seek lower exposures Bob Perciasepe, environmental effects of their programs, and consequently reductions in Acting Administrator. policies, and activities on minority chemical risks for themselves and their Therefore, it is proposed that 40 CFR populations and low-income children. This information can also be part 372 be amended as follows: populations in the United States. EPA used by government agencies and others has determined that this proposed rule to identify potential problems, set PART 372—TOXIC CHEMICAL will not have disproportionately high priorities, and take appropriate steps to RELEASE REPORTING: COMMUNITY and adverse human health or reduce any potential risks to human RIGHT–TO–KNOW environmental effects on minority or health and the environment. Therefore, low-income populations because it does the informational benefits of the ■ 1. The authority citation for part 372 not affect the level of protection proposed rule will have a positive continues to read as follows: provided to human health or the impact on the human health and Authority: 42 U.S.C. 11023 and 11048. environmental impacts of minority environment. This proposed rule adds ■ 2. The table in § 372.65 paragraph (c) populations, low-income populations, an additional chemical to the EPCRA is amended by adding an entry in and children. section 313 reporting requirements. By alphabetical order for ‘‘Nonylphenol’’ to adding a chemical to the list of toxic List of Subjects in 40 CFR Part 372 read as follows: chemicals subject to reporting under section 313 of EPCRA, EPA would be Environmental protection, § 372.65 Chemicals and chemical providing communities across the Community right-to-know, Reporting categories to which the part applies. United States (including minority and recordkeeping requirements, and * * * * * populations and low income Toxic chemicals. (c) * * *

[FR Doc. 2013–14754 Filed 6–19–13; 8:45 am] Fisheries Service (NMFS) periodically complete the required fields, and enter BILLING CODE 6560–50–P review existing regulations that have a or attach your comments. significant economic impact on a • Mail: Submit written comments to substantial number of small entities, Wendy Morrison, National Marine DEPARTMENT OF COMMERCE such as small businesses, small Fisheries Service, NOAA, Office of organizations, and small governmental Sustainable Fisheries, 1315 East-West National Oceanic and Atmospheric jurisdictions. This plan describes how Highway, Silver Spring, MD 20910 Administration NMFS will perform this review and (mark outside of envelope ‘‘Comments describes the regulations that are being on 610 review’’). • 50 CFR Chapters II, III, IV, V, and VI proposed for review during the current Fax: 301–713–1193; Attn: Wendy review-cycle. Morrison. RIN 0648–XC637 Instructions: Comments must be DATES: Written comments must be submitted by one of the above methods Plan for Periodic Review of received by NMFS by July 22, 2013. to ensure that the comments are Regulations ADDRESSES: You may submit comments received, documented, and considered AGENCY: National Marine Fisheries on this document, identified by NOAA– by NMFS. Comments sent by any other Service (NMFS), National Oceanic and NMFS–2012–0160, by any of the method, to any other address or Atmospheric Administration (NOAA), following methods: individual, or received after the end of Commerce. • Electronic Submission: Submit all the comment period, may not be ACTION: Proposed rule; request for electronic public comments via the considered. All comments received are comments. Federal e-Rulemaking Portal. Go to a part of the public record and will www.regulations.gov/ generally be posted for public viewing SUMMARY: The Regulatory Flexibility Act #!docketDetail;D=NOAA-NMFS-2012- on www.regulations.gov without change. (RFA) requires that the National Marine 0160, click the ‘‘Comment Now!’’ icon, All personal identifying information

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