Federal Register Vol. 80, No.65,

Table of Acronyms ANPRM Advance Notice of Proposed Rulemaking CFR Code of Federal Regulation DHS Department of Homeland Security FR Federal Register A. Public Participation and Request for Comments

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at http://www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, type the docket number in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this advanced notice of proposed rulemaking. The following link should take you directly to the docket: http://www.regulations.gov/#!docketDetail;D=USCG-2014-1009. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We have not scheduled a public meeting at this time. Once a public meeting is scheduled, we will publish a notice in the Federal Register separate from this ANPRM but within the same Docket Number USCG-2014-1009.

As reflected in title 33 Code of Federal Regulation section 109.05 (33 CFR 109.05), the Commandant of the U.S. Coast Guard has delegated the authority to establish anchorage grounds to U.S. Coast Guard District Commanders. The Coast Guard establishes Anchorage Grounds under authority of the authority in section 7 of the act of March 4, 1915, as amended (38 Stat. 1053; 33 U.S.C. 471) and places these regulations in Title 33 CFR part 110.1, subpart B. [CGFR 67-46, 32 FR 17728, Dec. 12, 1967, as amended by CGD 86-082, 52 FR 33811, Sept. 8, 1987; USCG-1998-3799, 63 FR 5526, June 30, 1998]. The Coast Guard is now considering a proposed rulemaking to establish two new offshore anchorage grounds. The two new anchorages are referenced in this document as South Timbalier Anchorage West and South Timbalier Anchorage East.

The legal basis and authorities for this advance notice of proposed rulemaking are found in 33 U.S.C. 471, 1221 through 1236; 33 CFR 1.05-1, Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to propose, establish, and define regulatory anchorages. The Coast Guard is now considering a proposed rulemaking establishing two offshore anchorage grounds; South Timbalier Anchorage West and South Timbalier Anchorage East.

The Coast Guard received a request from the Greater Lafourche Port Commission and its users to consider the establishment of a suitable anchorage or anchorage areas offshore in the vicinity of Port Fourchon, LA to alleviate and provide relief to vessel traffic and congestion in the port of Port Fourchon, LA. The volume of vessel traffic through Port Fourchon has increased over 30 percent since 2009. We expect continued growth within the Port in the coming years. Additionally, vessels to service the deepwater oil and gas industry continue to grow larger in size. For these reasons, the Coast Guard is considering the request to establish new offshore anchorages. This request was presented and discussed at a Greater Lafourche Port Commission Committee meeting on September 24, 2014, and with the Louisiana Department of Natural Resources on November 13, 2014.

The purpose of this ANPRM is to solicit input and comments on potential proposed rulemakings to help accommodate increased vessel volume and future increases and improve navigation safety for vessels transiting the Port Fourchon area, providing for the overall safe and efficient flow of vessel traffic and commerce. This objective would be to establish offshore anchorages intended to increase the safety of life and property on navigable waters, improve the safety of vessels operating, transiting, or anchored and moored in the vicinity of the port of Port Fourchon and provide for the overall safe and efficient flow of vessel traffic and commerce in the area.

The Coast Guard is considering establishing two new offshore anchorages supporting the vessel traffic in and around the Port of Port Fourchon, LA area. Preliminary details describing and an image depicting these anchorages are provided below.

The intended users of the proposed anchorages are Offshore Supply Vessels (OSV) and other vessels using or providing services within Port Fourchon, LA and on the outer-continental shelf.

As described by the Executive Director of the Greater Lafourche Parish Port Commission (GLPC), the volume of vessel traffic through Port Fourchon has increased over 30 percent since 2009. The GLPC estimates significant, continued growth in the near future. Due to congestion, Port Fourchon tenant companies and users either direct vessels dynamically position within a berth, Belle Pass, Bayou Lafourche, or Flotation Canal or depart the port entirely until a berth is available. Vessels servicing the deepwater oil and gas industry in and around Port Fourchon continue to grow in length and tonnage. The largest OSV's are 300 feet and over 4,500 Gross Tons. OSV's within Port Fourchon are often moored three or four abreast, requiring constant shifting and repositioning of vessels, crewmembers, and dockworkers, greatly increasing the risks of collisions, groundings, or harm to personnel.

The approximate depths of the proposed anchorages range from 36 feet to 60 feet, which will accommodate a variety of vessel types and configurations. The nearest safety fairways are the Belle Pass Safety Fairway approximately 3 nautical miles to the east and the Southwest Pass to Gulf Safety Fairway approximately 50 nautical miles to the south.

Based on National Automatic Identification System data, establishing an anchorage in the proposed location will have negligible effects on customary shipping lanes.

We are considering proposing that the South Timbalier Anchorage West would cover an area 7 nautical miles long by 5 nautical miles wide. Also, we are contemplating the following boundaries for the anchorage:

• The western boundary would match the western boundary of South Timbalier blocks 16 and 33;

• The eastern boundary would match eastern boundary of South Timbalier blocks 18 and 31;

• The northern boundary would match the northern boundary of South Timbalier blocks 16, 17, and 18; and

• The southern boundary would match the southern boundary of South Timbalier blocks 31, 32, and 33.

The anchorage we are contemplating may also be represented by drawing rhumb lines joining points at:

We are considering proposing that the South Timbalier Anchorage East would cover an area 5 nautical miles wide by 5 nautical miles deep. The following are the contemplated proposed boundaries for the anchorage.

The western boundary would match the western boundary of South Timbalier blocks 20 and 29.

The eastern boundary would match the eastern boundary of South Timbalier blocks 21 and 28.

The northern boundary would match the northern boundary of South Timbalier blocks 20 and 21.

The southern boundary would match the southern boundary of South Timbalier blocks 29 and 28.

The South Timbalier Anchorage East anchorage we are contemplating may also be represented may by drawing rhumb lines joining points at:

We have also placed illustrations of the currently contemplated offshore anchorage grounds in the docket (http://www.regulations.gov/#!docketDetail;D=USCG-2014-1009). Look for a supporting document with “Illustrations” in its title.

In a letter to the National Oceanographic and Atmospheric Administration, the Coast Guard will request that the Office of Coast Survey ensure the suitability and safety of the contemplated anchorage grounds. Additionally, the Coast Guard is coordinating with the Bureau of Ocean Energy Management, the Bureau of Safety and Environmental Enforcement, and the State of Louisiana's Department of Natural Resources to verify the location of existing pipeline corridors.

The contemplated anchorage area is larger than the envisioned final anchorage. This advance notice of proposed rulemaking is intended to prompt discussion and gather input from the affected marine industries to determine the most appropriate anchorage within the contemplated area.

Public participation is requested to assist in determining the best way forward in developing a proposed rulemaking to establish these offshore anchorages. To aid us in developing a proposed rule, we seek any comments, whether positive or negative, including but not limited to the impacts anchorage areas may have on navigation safety and current vessel traffic in this area.

Please submit any comments or concerns you may have in accordance with the “submitting comments” section above.

This document is issued under authority of 5 U.S.C. 552; 33 CFR 1.05-1, and 1.05-30.

EPA proposes to approve the State of Tennessee's UIC Program primacy application for Class I, II, III, IV, and V injection wells located within the state (except all wells on Indian lands), as required by rule under the SDWA, to prevent underground injection activities that endanger underground sources of drinking water. Accordingly, the Agency proposes to codify the state's program in the Code of Federal Regulations (CFR) at 40 CFR part 147. EPA will continue to administer the UIC Program for Class VI wells and wells on Indian lands, if any such lands exist in the state in the future. The Agency has published a direct final rule in the “Rules and Regulations” section of today's Federal Register, approving the state's program because EPA views these actions as noncontroversial and anticipates no adverse comment. The Agency has provided reasons for the approval and additional supplementary information in the preamble to the direct final rule. If EPA receives no adverse comment, the Agency will not take further action on this proposed rule. If EPA receives adverse comment, the Agency will withdraw the direct final rule and it will not take effect. The Agency would then address all public comments in any subsequent final rule based on this proposed rule. The Agency does not intend to institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please contact the persons listed in the FOR FURTHER INFORMATION CONTACT section of this document.

Why is EPA issuing this proposed rule?

EPA proposes to approve by rule the state's UIC Class V Program revisions and the transfer of oversight authority from the Department of Ecology to the Energy Facility Site Evaluation Council to issue UIC permits at energy facilities, as required under the SDWA to prevent underground injection activities that endanger underground sources of drinking water. Accordingly, the Agency proposes to codify the state's program revisions in the Code of Federal Regulations (CFR) at 40 CFR part 147. The Agency has published a direct final rule in the “Rules and Regulations” section of this Federal Register, approving the state's program revisions, because EPA views the revisions as noncontroversial and anticipates no adverse comment. The Agency provided reasons for the approval and additional supplementary information in the preamble to the direct final rule. If EPA receives no adverse comment, the Agency will not take further action on this proposed rule. If EPA receives adverse comment, the Agency will withdraw the direct final rule and it will not take effect. The EPA would then address all public comments in any subsequent final rule based on this proposed rule. The EPA does not intend to institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please contact the persons in the FOR FURTHER INFORMATION CONTACT section of this document.

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT for the division listed at the end of the pesticide petition summary of interest.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.

Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available at http://www.regulations.gov.

As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.

1. PP 3F8206. (EPA-HQ-OPP-2014-0852). Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide safener fluxofenim (CAS Reg. No. 88485-37-4) in or on the raw agricultural commodities grain sorghum, grain; grain sorghum, forage; and grain sorghum, fodder at 0.01; 0.01; and 0.01 parts per million (ppm), respectively. The analytical method high performance liquid chromatography with triple quadrupole mass spectrometric detection (LC-MS/MS) is used to measure and evaluate the pesticide residues. Contact: RD.

2. PP 4E8328. (EPA-HQ-OPP-2014-0878). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide fluazifop-p-butyl in or on the raw agricultural commodities: Lettuce, head and leaf at 5.0 parts per million (ppm); strawberry at 3.0 ppm; onion, green at 1.5 ppm; caneberry subgroup 13-07A at 0.05 ppm; bushberry subgroup 13-07B at 0.3 ppm; tuberous and corm vegetables (except for potato) subgroup 1D at 1.5 ppm; small fruit vine climbing, except for fuzzy kiwifruit subgroup 13-07F, 0.03 ppm; and onion, bulb subgroup 3-07A at 0.5 ppm as well as tolerances with regional registration for grass hay at 15 ppm; and grass forage at 4.0 ppm. Upon the approval of the aforementioned tolerances, IR-4 requests removal of the existing tolerances for grape at 0.01 ppm; onion, bulb at 0.5 ppm; and sweet potato, roots at 0.05 ppm. Analytical methodology has been developed and validated for enforcement purposes. This method has been submitted to the Agency and is in PAM Vol. II, Method II. Contact: RD.

3. PP 4E8335. (EPA-HQ-OPP-2014-0922). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of the sum of zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 parts per million (ppm) and vegetable, tuberous and corm, subgroup 1C at 0.060 ppm. In addition, IR-4 requests to establish tolerances for residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxypropyl)-4-methylbenzamide, in or on raw agricultural commodity tomato subgroup 8-10A at 2.0 ppm and fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm. IR-4 also proposes, upon the approval of the aforementioned tolerances, to remove established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm. Adequate enforcement methodology is available to enforce the tolerance expression. Contact: RD.

4. PP 4F8253. (EPA-HQ-OPP-2014-0679). ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide, cyclaniliprole, in or on Pome Fruit (Crop Group 11-10) at 0.3 parts per million (ppm), Tree Nuts (Crop Group 14-12) at 0.02 ppm, Stone Fruit (Crop Group 12-12) at 0.7 ppm Fruiting Vegetables, (Crop Group 8-10) at 0.2 ppm, Cucurbit Vegetables, (Crop Group 9) at 0.2 ppm, Small Fruit Vine Climbing Subgroup except Fuzzy Kiwifruit (Crop Group 13-07F), at 0.9 ppm. Additionally tolerances are proposed for the crops in the proposed Crop Subgroup 4-14A, Leafy greens subgroup at 7.0 ppm including amaranth, Chinese; amaranth, leafy; aster, Indian; blackjack; cat's whiskers; chervil, fresh leaves; cham-chwi; cham-namul; chipilin; chrysanthemum, garland; cilantro, fresh leaves; corn salad; cosmos; dandelion; dang-gwi; dillweed; dock; dol-nam-mul; ebolo; endive; escarole; fameflower; feather cockscomb; good king henry; huauzontle; jute, leaves; lettuce, bitter; lettuce, head; lettuce, leaf; orach; parsley, fresh leaves; plantain, buckhorn; primrose, English; purslane, garden; purslane, winter; radicchio; spinach; spinach, malabar; spinach, New Zealand; spinach, tanier; swiss chard; and violet, Chinese; crops in the proposed Crop Subgroup 4-14B, Brassica leafy greens subgroup at 15 ppm including Arugula; broccoli raab; broccoli, Chinese; cabbage, abyssinian; cabbage, seakale; Chinese cabbage, bok choy; collards; cress, garden; cress, upland; hanover salad; kale; maca; mizuna; mustard greens; radish, leaves; rape greens; rocket, wild; shepherd's purse; turnip greens; and watercress; crops in the proposed Crop Subgroup 22B, Leaf petiole vegetable subgroup at 7.0 ppm including Cardoon; celery; celery, Chinese; fuki; rhubarb; udo; zuiki and the crops in the proposed Crop Group 5-14: Brassica Head and Stem Vegetable at 1.5 ppm including broccoli; Brussels sprouts; cabbage; cabbage, Chinese, napa; and cauliflower. Tolerances are also proposed for the animal feed commodities Almond, hulls at 8.0 parts per million (ppm), Apple, wet pomace at 0.96 parts per million (ppm), in animal tissues and meat by products: Cattle, fat at 0.08 ppm; cattle, kidney at 0.08 ppm; cattle, liver at 0.1 ppm; cattle, meat at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, fat at 0.08 ppm; goat, kidney at 0.08 ppm; goat, liver at 0.1 ppm; goat, meat at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, fat at 0.08 ppm; horse, kidney at 0.08 ppm; horse, liver at 0.1 ppm; horse, meat at 0.02 ppm; horse, meat byproducts at 0.02 ppm; milk at 0.01 ppm; sheep, fat at 0.08 ppm; sheep, kidney at 0.08 ppm; sheep, liver at 0.1 ppm; sheep, meat at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm and for the import commodity Tea (dried and instant) at 40 parts per million (ppm). The analytical method Liquid Chromatography-MS/MS is used to measure and evaluate the pesticide residues. Contact: RD.

5. PP 4F8308. (EPA-HQ-OPP-2014-0913). SePRO Corporation, 11550 North Meridian Street, Suite 600, Carmel, IN 46032, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide, fluridone, in or on cotton, undelinted seed at 0.1 parts per million (ppm). The enzyme-linked immunosorbant assay (ELISA), high performance liquid chromatography with ultraviolet detection (HLPC/UV), and liquid chromatography with tandem mass spectroscopy (LC-MSMS) method is used to measure and evaluate the chemical residues. Contact: RD.

6. PP 4F8323. (EPA-HQ-OPP-2015-0014). Syngenta Crop Protection, LLC, 410 Swing Road, Greensboro, NC 27419, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide, mefenoxam, in or on Rapeseed Crop Subgroup 20A at 0.05 parts per million (ppm). The Novartis Crop Protection Method 456-98 and Ciba-Geigy Corporation Procedure AG-395 were used to measure and evaluate the chemical mefenoxam: methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate. Contact: RD.

1. PP IN-10699. (EPA-HQ-OPP-2014-0449). Exponent, 1150 Connecticut Ave. NW., Washington, DC 20036, on behalf of ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish an exemption from the requirement of a tolerance for residues of 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)ocy]-1-disiloxanyl]propoxy]- (CAS Reg. No. 70280-68-1), when used as a pesticide inert ingredient in pesticide formulations applied to growing crops only under 40 CFR 180.920. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

2. PP IN-10771. (EPA-HQ-OPP-2014-0853). Exponent, 1150 Connecticut Ave. NW., Washington, DC 20036, on behalf of Cheminova A/S, 1600 Wilson Boulevard, Suite 700, Arlington, VA 22209, requests to establish an exemption from the requirement of a tolerance for residues of maleic anhydride (CAS Reg. No. 108-31-6), when used as an inert ingredient in pesticide formulations applied to growing crops only under 40 CFR 180.920. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

3. PP IN-10775. (EPA-HQ-OPP-2015-0143). Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC, requests to establish an exemption from the requirement of a tolerance for residues of propylene glycol monomethyl ether (CAS Reg. No. 107-98-2) when used as an inert ingredient in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910. The petitioner believes no analytical method is needed because it is not required for exemption from the requirement of a tolerance. Contact: RD.

4. PP IN-10777. (EPA-HQ-OPP-2015-0019). Ag-Chem Consulting, LLC, 12208 Quinque Lane, Clifton, VA 20124 on behalf of Omex Agrifluids, 24730 Avenue 13, Madera, CA 93637, requests to establish an exemption from the requirement of a tolerance for residues of salicylaldehyde (2-hydroxybenzaldehyde) (CAS Reg. No. 90-02-8) when used as an inert ingredient in pesticide formulations at no more than 14% of the pesticide formulation. The petitioner believes no analytical method is needed because it is it is not required for an exemption from the requirement of a tolerance. Contact: RD.

5. PP IN-10780. (EPA-HQ-OPP-2015-0020). Technology Sciences Group, Inc., 1150 18th Street NW., Suite 1000, Washington, DC 20036, on behalf of BYK Additives Inc., 1600 W. Hill Street, Louisville, KY 40210, requests to establish an exemption from the requirement of a tolerance for residues of quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite (CAS Reg. No. 1588523-05-0), when used as an inert ingredient in pesticide formulations applied to growing crops only under 40 CFR 180.920. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

6. PP IN-10781. (EPA-HQ-OPP-2015-0018). Technology Sciences Group, Inc., 1150 18th Street NW., Suite 1000, Washington, DC 20036, on behalf of BYK Additives, Inc., 1600 W. Hill Street, Louisville, KY 40210, requests to establish an exemption from the requirement of a tolerance for residues for quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite (CAS Reg. No. 1574487-61-8), when used as an inert ingredient in pesticide formulations applied to growing crops only under 40 CFR 180.920. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

7. PP IN-10784. (EPA-HQ-OPP-2015-0064). Momentive Performance Materials, 260 Hudson River Rd., Waterford, NY 12188, on behalf of the Dow Chemical Company, 2301 N. Brazosport Blvd., Freeport, TX 77541, requests to establish an exemption from the requirement of a tolerance for residues of acrylic acid, butyl acrylate, styrene copolymer (CAS Reg. No. 25586-20-3) with a minimum number average molecular weight (in amu) of 5,200, when used as an inert ingredient in pesticide formulations under 40 CFR 180.960. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

1. PP 2E8080. (EPA-HQ-OPP-2013-0098). Toxcel, LLC, 7140 Heritage Village Plaza, Gainesville, VA 20156 on behalf of Penn A Kem, LLC, 3324 Chelsea Avenue, Memphis, TN 38108, requests to amend an exemption from the requirement of a tolerance in 40 CFR 180.1263 for residues of tetrahydrofurfuryl alcohol (THFA), (CAS Reg. No. 97-99-4), when used as a pesticide inert ingredient (solvent/co-solvent), to include allowance of one herbicide application prior to the preboot stage to wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and wild rice; extended use on canola to the early bolting stage; extended use on soybeans up to the bloom growth stage; and allowance of use in herbicides with two applications to field corn and pop corn up to 36 inches tall (V8 stage). The petitioner believes no analytical method is needed because it is not required for the amendment of an exemption from the requirement of a tolerance. Contact: RD.

2. PP 4F8336. (EPA-HQ-OPP-2008-0762). BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709, requests to amend an exemption from the requirement of a tolerance in 40 CFR 180.1128 for residues of the biofungicide, Bacillus amyloliquefaciens MBI 600 (antecedent Bacillus subtilis MBI 600), in or on all food commodities, including residues resulting from post-harvest uses, when applied or used in accordance with good agricultural practices. The petitioner believes no analytical method is needed because Bacillus amyloliquefaciens MBI 600 (antecedent Bacillus subtilis MBI 600) has an exemption from the requirement of a tolerance without numerical limitations. Contact: BPPD.

PP 4E8328. (EPA-HQ-OPP-2014-0878). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to amend the existing tolerance in 40 CFR part 180.411 for residues of the herbicide fluazifop-p-butyl in or on rhubarb, from 0.5 parts per million (ppm) to 0.4 ppm. Analytical methodology has been developed and validated for enforcement purposes. This method has been submitted to the Agency and is in PAM Vol. II, Method II. Contact: RD.

I. Executive Summary A. Does this action apply to me?

You may be potentially affected by this action if you manufacture or process or intend to manufacture or process nanoscale forms of certain chemical substances. However, persons that manufacture or process, or intend to manufacture or process these chemical substances as part of articles, as impurities, or in small quantities solely for research and development would not be subject to this action. In addition, the discussion in Unit III.A. describes in more detail which chemical substances would and would not be subject to reporting under the proposed rule. You may also consult 40 CFR 704.3 and 704.5, as well as the proposed regulatory text in this document, for further information on the applicability of these and other exemptions to this proposed rule.

The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document may apply to them:

• Chemical Manufacturing or Processing (NAICS codes 325).

• Synthetic Dye and Pigment Manufacturing (NAICS code 325130).

• Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).

• Rolled Steel Shape Manufacturing (NAICS code 331221).

• Semiconductor and Related Device Manufacturing (NAICS code 334413).

• Carbon and Graphite Product Manufacturing (NAICS code 335991).

• Home Furnishing Merchant Wholesalers (NAICS code 423220).

• Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330).

• Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510).

• Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) (NAICS code 541712).

The Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., provides EPA with authority to require reporting, recordkeeping and testing, and impose restrictions relating to chemical substances and/or mixtures. EPA is proposing this rule under section 8(a) of TSCA, 15 U.S.C. 2607(a). See also Unit II.A.

EPA is proposing reporting and recordkeeping requirements for persons that manufacture (including import) or process certain chemical substances as described in Unit III.A. Persons who currently manufacture or process these chemical substances as discrete nanoscale materials would be required to notify EPA of certain information described in Unit III.C., including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data. EPA is also proposing that any persons who intend to begin to manufacture or process chemical substances as discrete nanoscale materials after the effective date of this rule notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing. The TSCA section 8(a) rule proposed here involves one-time reporting for existing discrete nanoscale forms of certain chemical substances and one-time reporting for new discrete nanoscale forms of certain chemical substances before they are manufactured or processed. A chemical substance as defined under TSCA section 3(2) does not include any food, food additive, drug, cosmetic, medical device, pesticide or other excluded materials. Such materials are not be subject to this rule.

Included in this proposal are electronic reporting requirements similar to those established in 2013 for other kinds of information: EPA is proposing to require submitters to use EPA's Central Data Exchange (CDX), the Agency's electronic reporting portal, for all reporting under this rule. In the Federal Register of December 4, 2013 (78 FR 72818) (FRL 9394-6), EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). In proposing to require similar electronic reporting under this rule, EPA intends to save time, improve data quality and increase efficiencies for both the submitters and the Agency (Ref. 1).

This proposed rule and the discussion of the potential risks do not conclude and are not intended to conclude that nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give rise to or are likely to cause harm to people or the environment. Rather, EPA would use information gathered through this reporting rule to determine if any further action under TSCA, including additional information collection, is needed. EPA intends to make conclusions on the basis of specific scientific evidence. As with current new chemical review of nanomaterials, each chemical substance manufactured at the nanoscale will be evaluated on a case-by-case basis and not with the presumption of either harm or safety, but rather its evaluation will be based on the specific nanoscale chemical substance's own properties. If adequate data are not available for the properties of the nanoscale chemical substance, EPA will use data on structural analogues. Being nanoscale is not itself an indication of, or criterion for, hazard or exposure potential. Any potential future restrictions on chemical substances manufactured at the nanoscale would be tailored to protect against the specific harms identified for individual substances or categories. EPA would focus any toxicity concerns or data requirements based on available exposure or hazard data for specific nanoscale chemical substances. If the information provided indicates low risk, EPA would not need to consider further review or regulation of that nanoscale chemical substance unless subsequent information raises risk concerns. For example during review of new chemical substances that are nanoscale materials, EPA typically does not request inhalation toxicity data for chemical substances that are manufactured in forms or handled by processes where no inhalation exposure occurs.

EPA is not proposing to publish an inventory of chemical substances manufactured at the nanoscale based on the information that would be collected pursuant to these proposed TSCA section 8(a) reporting requirements. EPA will make non-confidential information reported under the proposed rule available in ChemView (see http://www.epa.gov/chemview/).

These reporting and recordkeeping requirements would assist EPA in its continuing evaluation of chemical substances manufactured at the nanoscale, informed by available scientific, technical and economic evidence. This proposed rule is not intended to indicate restrictions or conclusions about the risks of chemical substances manufactured at the nanoscale in general. Rather, the requirements would facilitate EPA's evaluation of the materials and its determination of whether any further action under TSCA, including additional information collection, is needed.

Consistent with the June 9, 2011 memorandum on the Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, this proposal is not making any finding about the potential risks of nanoscale materials in general or any specific nanoscale materials (Ref. 2). These generally applicable principles are relevant to promoting a balanced, science-based approach to regulating chemical substances manufactured at the nanoscale and other applications of nanotechnology in a manner that protects human health, safety, and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation. These principles build on the foundation provided by current regulatory statutes and do not supersede existing legal authorities. In this proposal, EPA's approach seeks to support the policy principle to “[s]eek and develop adequate information with respect to the potential effects of nanomaterials on human health and the environment and take into account new knowledge when it becomes available” (Ref. 2). As with current new chemical reviews of chemical substances manufactured at the nanoscale, each nanoscale material would be evaluated on a case-by-case basis and not with the presumption of either harm or safety. Any evaluation will be based on the specific nanoscale material's own properties and those of any structural analogs.

EPA has evaluated the potential costs of establishing the proposed reporting and recordkeeping requirements for potential manufacturers and processors. This analysis (Ref. 3), which is available in the docket, is briefly summarized here.

Under the proposed rule, industry is conservatively estimated to incur a burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 million and $1.5 million, respectively (see Chapter 3 in Ref. 3), while the Agency is expected to use approximately 6,539 hours in the first year and 723 hours in subsequent years, with costs of approximately $0.51 million and $0.06 million respectively (see Chapter 4 in Ref. 3). Discounted over a 10-year period at three and seven percent, total annualized costs are estimated to be approximately $2.80 million and $3.08 million, respectively. (Ref. 3.)

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

1. TSCA section 8(a) reporting. Section 8(a) of TSCA authorizes EPA to promulgate rules which require each person (other than a small manufacturer or processor) who manufactures, processes, or proposes to manufacture or process a chemical substance, to maintain such records and submit such reports as the EPA Administrator may reasonably require. TSCA section 8(a) gives EPA authority to determine the format of reporting under this section.

Small manufacturers and processors, as defined by EPA, are exempt from TSCA section 8(a) reporting requirements, unless the manufacture or processing is subject to a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, or an order under section 5(e). Under TSCA section 8(a)(3)(B), after consultation with the Administrator of the Small Business Administration (SBA), EPA may prescribe standards for determining which manufacturers and processors qualify as small for purposes of reporting under a TSCA section 8(a) rule.

General provisions for TSCA section 8(a) rules appear in 40 CFR part 704 Subpart A. These provisions describe definitions, exemptions (including for articles and research and development), confidential business information claims, and recordkeeping that apply to TSCA section 8(a) rules. For example in 40 CFR 704.3 the definition of known to or reasonably ascertainable by is defined to mean all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.

In addition, the definitions in TSCA section 3 apply to this rulemaking.

2. Electronic reporting under the Government Paperwork Elimination Act (GPEA). GPEA, 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3) (Ref. 4), provides that any requirement in title 40 of the CFR to submit a report directly to EPA can be satisfied with an electronic submission that meets certain conditions once the Agency published a document in the Federal Register announcing that EPA is prepared to receive certain documents in electronic form. For more information about CROMERR, go to http://www.epa.gov/cromerr.

There is a growing body of scientific evidence showing the differences that exist between chemical substances and chemical substances manufactured in nanoscale forms (Ref. 5). Chemical substances manufactured at the nanoscale may have different or enhanced properties—for example, electrical, chemical, magnetic, mechanical, thermal, or optical properties—or features, such as improved hardness or strength, that are highly desirable for applications in commercial, medical, military, and environmental sectors (Ref. 6). These properties are a direct consequence of decreasing size, where surface area per unit of volume increases exponentially and quantum effects may appear in the low tens of nanometers and below. Small size itself can also be a desirable property of nanoscale materials. The small size can be exploited for miniaturization of applications/processes and/or stabilization or delivery of payloads to diverse environments or incorporation into diverse products.

Nanoscale materials have a range of potentially beneficial public and commercial applications, including medicine and public health, clean energy, pollution reduction and environmental cleanup, and improved products such as stronger, lighter, and more durable or conductive materials. These benefits arise from the distinctive properties of nanoscale materials, in that they are potentially more interactive or durable than other chemical substances. Altering the size of a material from conventional particle size can enhance or produce unique properties that are desirable for a variety of commercial applications. However, these unique and enhanced properties can raise new questions, such as whether the material in the smaller form may present increased hazards to humans and the environment.

Government, academic, and private sector scientists in multiple countries are performing research into the environmental and human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence. This research also indicates that, in biological systems or in the environment, not all materials in the nanoscale size range behave differently from larger sized materials of the same substance (Ref. 7). Recently, a governmental organization and an independent scientific committee have reviewed and summarized this evidence and offered views about the implications of this evidence for environmental and human health and safety.

In 2009, the National Institute of Occupational Safety and Health (NIOSH) issued a report (Ref. 8) that summarized the available scientific information about nanoscale materials and identified the following potential health and safety properties:

• “Nanomaterials have the greatest potential to enter the body through the respiratory system if they are airborne and in the form of respirable-sized particles (nanoparticles). They may also come into contact with the skin or be ingested.”

• “Based on results from human and animal studies, airborne nanoparticles can be inhaled and deposited in the respiratory tract; and based on animal studies, nanoparticles can enter the blood stream, and translocate to other organs.”

• “Experimental studies in rats have shown that equivalent mass doses of insoluble incidental nanoparticles are more potent than large particles of similar composition in causing pulmonary inflammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally supportive of the biological responses observed in animals.”

• “Experimental studies in animals, cell cultures, and cell-free systems have shown that changes in the chemical composition, crystal structure, and size of particles can influence their oxidant generation properties and cytotoxicity.”

• “Studies in workers exposed to aerosols of some manufactured or incidental microscopic (fine) and nanoscale (ultrafine) particles have reported adverse lung effects including lung function decrements and obstructive and fibrotic lung diseases. The implications of these studies to engineered nanoparticles, which may have different particle properties, are uncertain.”

• “Some nanomaterials may initiate catalytic reactions depending on their composition and structure that would not otherwise be anticipated based on their chemical composition.”

Earlier the same year, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), an independent scientific committee advising the European Commission's Health and Consumer Directorate, issued a report (Ref. 9) that identified properties similar to those identified in the NIOSH report:

• “Some specific hazards, discussed in the context of risk for human health, have been identified. These include the possibility of some nanoparticles to induce protein fibrillation, the possible pathological effects caused by specific types of carbon nanotubes, the induction of genotoxicity, and size effects in terms of biodistribution.”

• “For some nanomaterials, toxic effects on environmental organisms have been demonstrated, as well as the potential to transfer across environmental species, indicating a potential for bioaccumulation in species at the end of that part of the food chain.”

In another survey of scientific research on nanoscale materials (Ref. 10), the authors reported:

A report in the scientific literature has indicated that nanoscale polystyrene beads may cross the placental barrier (in an ex-vivo human placental perfusion model (Ref. 11). Another study found that nanoparticles could translocate to diverse organs following oral exposure in rodents. Once in these diverse sites and organs, the large surface area of nanoscale materials may facilitate increased reactivity and/or an inflammatory response, resulting in toxic effects (Ref. 12).

Two literature surveys describe a broad range of effects in non-mammalian species following exposure to nanoscale materials (Ref. 13 and 14). These include, for example, increased ventilation rates, mucus production, and pathologies, and related alteration of enzyme activities and indicators of oxidative stress in rainbow trout, Oncorhyncus mykiss (Ref. 15) and ingestion and accumulation of nanoscale material in the digestive tract, as well as mortality, increased heart rates, and reduced fecundity in Daphnia magna (Ref. 16, 17, and 18). Translocation of nanoscale materials from gill and gut surface to blood and other organs in exposed Medaka, Oryzius latipes, has also been reported (Ref. 19) and carbon nanotubes, although unable to cross the egg surface, have been shown to delay hatching in zebra fish, Danio rerio (Ref. 20).

Published reports of human and ecological exposure to nanomaterials are also limited. For example, in its “Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers” (Ref. 21), NIOSH summarized and evaluated the available published information on worker exposures to carbon nanotubes (CNT) and nanofibers (CNF). NIOSH determined that, although the potential for worker exposure to CNT and CNF can occur throughout the life cycle of CNT- and CNF-product use (processing, use, disposal, recycling), the extent to which workers are exposed has not been completely characterized. “Comprehensive workplace exposure evaluations are needed to characterize and quantify worker exposure to CNT and CNF at various job tasks and operations, and to determine what control measures are the most effective in reducing worker exposures.” “Data are particularly needed on workplace exposures to CNT and CNF, as well as information on whether in-place exposure control measures (e.g., engineering controls) and work practices are effective in reducing worker exposures.”

There are many scientific questions about the impacts of chemical substances manufactured at the nanoscale on human health and the environment. Part of EPA's mission under TSCA is to understand potential risks in order to protect human health and the environment. As stated in EPA's White Paper on Nanotechnology (Ref. 22):

As described in the 2008 TSCA Inventory Status of Nanoscale Substances—General Approach, many nanoscale materials are considered chemical substances as defined under TSCA section 3(2) (Ref. 23). Nanoscale forms of chemical substances that are not on the TSCA Inventory in any form are considered new chemical substances that require reporting under TSCA section 5. EPA has assessed over 170 of these nanoscale materials as new chemical substances and taken action to control exposures to prevent any potential unreasonable risks to human health or the environment pending development of information which will allow EPA to more fully assess those risks. Nanoscale materials based on chemical substances already on the TSCA Inventory are considered existing chemical substances. These nanoscale materials do not require reporting as new chemical substances because they are nanoscale forms of chemical substances already in commerce.

EPA developed a voluntary Nanoscale Materials Stewardship Program (NMSP or “the program”) to complement and support its regulatory activities on chemical substances manufactured at the nanoscale. EPA conducted the program from January 2008 to December 2009. Thirty one companies or associations submitted information to EPA for 132 chemical substances manufactured at the nanoscale with available information on how those nanoscale materials were manufactured, processed or used. For more details on the NMSP, see the program's interim report, a copy of which is in the docket (Ref. 24). EPA solicited existing data and information, on a voluntary basis, from manufacturers, processors, and users of chemical substances manufactured at the nanoscale to expeditiously develop knowledge about commercially available nanoscale materials. In addition, the program was designed to identify and encourage use of risk management practices in developing and commercializing chemical substances manufactured at the nanoscale. EPA also participated in a series of National Nanotechnology Initiative public workshops, including co-Chairing a public Risk Management Methods workshop. This workshop was also useful in further identifying additional considerations in risk management practices towards developing and commercializing chemical substances manufactured at the nanoscale of interest to EPA. In the NMSP interim report, which was based on the information EPA received prior to January 2009, EPA identified data needs for existing nanoscale material production, uses, and exposures. For example, in the report EPA estimated that companies provided information on only about 10 percent of the chemical substances manufactured at the nanoscale that may be commercially available in 2009.

To address some of the data needs identified in the NMSP interim report, EPA is proposing reporting requirements under TSCA section 8(a) for persons who are manufacturing, or processing chemical substances manufactured at the nanoscale or intend to manufacture or process these nanoscale materials for commercial purposes. This information would facilitate EPA's evaluation of the materials and determination if any further action under TSCA, including additional information collection, is needed. By gathering data regarding the characteristics, uses, and exposure pertaining to chemical substances manufactured at the nanoscale, EPA will create a more robust database that will expand the Agency's understanding of commercially available nanoscale substances including available environmental health and safety data and risk management practices.

EPA is proposing reporting and recordkeeping requirements for manufacturers and processors of certain chemical substances pursuant to TSCA section 8(a).

1. Reportable chemical substances. This proposed rule would apply to chemical substances that are solids at 25 °C and atmospheric pressure and that are manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nanometers (nm) and exhibit unique and novel characteristics or properties because of their size. The proposed rule would apply to chemical substances containing primary particles, aggregates, or agglomerates in the size range of 1-100 nm in at least one dimension. This proposed rule would not apply to chemical substances that only have trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size. EPA is proposing these parameters for purposes of identifying chemical substances that are subject to the rule, not to establish a definition of what is a nanoscale material.

i. Discrete forms. Manufacturers and processors of multiple nanoscale forms of the same chemical substance would, in some cases, need to report separately for each discrete form of the reportable chemical substance. EPA is proposing to distinguish based on a combination of three factors: (1) a change in process to affect a change in size and/or a change in properties of the chemical substances manufactured at the nanoscale; (2) a change in mean particle size of 10% or greater; and (3) the measured change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values (+/− 7 times the standard deviation). For example if the specific surface area of one discrete form was measured to be 50 +/− 5 m2/g, then a change resulting in a new average specific area of 85 m2/g would be reportable if factors 1 and 2 were also met. EPA recommends using the same medium and method when measuring the change in these properties, as even minor changes in the medium and methods can result in large differences in the measured results. EPA's intent for proposing these reporting requirements is to focus reporting on intentionally manufactured chemical substances at the nanoscale.

EPA is proposing the combination of these three factors rather than simply size to distinguish between different chemical substances manufactured at the nanoscale so that unintended variation in size range between production batches would not trigger TSCA section 8(a) reporting. Also, EPA is proposing not to rely solely on process changes because there may be process changes that are not intended to change the material produced but rather intended to improve the efficiency of the process or to use a cheaper reactant. EPA is focusing on the properties of zeta potential, specific surface area, dispersion stability, or surface reactivity because these properties are of particular interest in a health and safety context, whereas other unique properties of chemical substances manufactured at the nanoscale (e.g., the wavelength at which light is emitted) may be important for how that form of the chemical substance functions but are less likely to be important in a health and safety context. EPA believes that the combination of these three factors will provide a clear and transparent way for the regulated community to distinguish among different chemical substances manufactured at the nanoscale for purposes of TSCA section 8(a) reporting.

For the purposes of this proposed rule, specific surface area is the ratio of the surface area of the nanoscale material to its mass or the area of the surface of the nanoscale material divided by volume. This is an important factor because chemical reactions take place at the surface of the material. Thus, the higher the surface area, the greater the chemical reactivity, which is an important consideration for human health toxicity and environmental toxicity assessments. Specific surface area is the ratio of the area of the surface of a nanoscale material divided by the mass (m2/kg) or the area of the surface of the nanoscale material divided by volume (m2/m3).

Zeta potential is the electrokinetic potential in colloidal systems. It is measured as the net number of positive and negative charges per unit particle surface area in Coulomb/m2 (Ref. 25) and is typically measured by electrophoresis.

Dispersion stability is the ability of a dispersion to resist changes in properties over time and can be defined in terms of the change in one or more physical properties over a given time period. See ISO/TR 13097:2013 “Guidelines for characterization of dispersion stability” (Ref. 26) as an example.

Surface reactivity is the degree to which the nanoscale material will react with biological systems. The surface reactivity of the form of a chemical substance is dependent upon factors such as redox potential which is a measure of the tendency of an entity to lose or acquire electrons, and photocatalytic activity, including the potential to generate free radicals. Reactive oxygen species (ROS) and free radicals are important in considering toxicity for these materials.

A nanoscale form of a particular chemical substance with a different morphology or shape would also qualify as a discrete form. Examples include spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, hollow shells, trees, flowers, rings, tori, cones, and sheets. Nanoscale forms of a particular chemical substance that are coated with different chemical substances would be considered discrete forms for each chemical coating.

ii. Chemical mixtures. Chemical substances that are manufactured or processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite would also have to be reported. Chemical substances at the nanoscale that are manufactured but are then incorporated into mixtures, encapsulated materials or composites by that manufacturer would not require separate reporting for their incorporation. However, the person reporting the chemical substance would have to report each step of its manufacture, processing and use to the extent it is known or reasonably ascertainable.

2. Substances excluded from reporting. EPA is proposing to exclude from the requirements of this rule certain biological materials (e.g., DNA, RNA, and proteins). EPA is seeking comment to identify other specific biological materials that should be excluded from reporting and the reasons for excluding them, including microorganisms and viral based products (or other combinations of RNA, DNA and protein), lipids, carbohydrates, enzymes, and peptides. However, the properties of biological materials such as DNA, RNA and proteins are not a function of the size range per se but rather the precise nucleotide sequence (in the case of DNA and RNA), shape, and other features.

EPA is proposing to exclude chemical substances which dissociate completely in water to form ions that are less than 1 nanometer. This exclusion would not apply to chemical substances manufactured at the nanoscale materials that release ions but do not dissociate in water to form those ions. EPA believes that the chemical substances that would be excluded do not exhibit new properties when their size falls in the range of 1-100 nanometers and manufacture or processing such substances at the nanoscale should therefore not be subject to the reporting requirements of the proposed rule. EPA is seeking comment to identify other water soluble compounds that should be excluded from reporting and the reasons for excluding them.

EPA is proposing to exclude from the requirements of this rule nanoclays, zinc oxide and chemical substances manufactured at the nanoscale as part of a film on a surface. The Agency believes that information collected on these materials would be of limited value because either they have been well-characterized or they present little exposure potential. EPA requests comment on these proposed exclusions and whether other chemical substances manufactured at the nanoscale should be excluded. EPA requests that commenters explain why they believe the chemical substances manufactured at the nanoscale should be excluded.

3. General exemptions to TSCA Section 8(a) reporting. The general exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 would be applicable to this proposed rule. This includes, among other exemptions, the exemption for research and development under which a person who manufactures or processes, a chemical substance only in small quantities for research and development would be exempt from the reporting requirements of this proposed rule. Examples of research and development (R&D) activity are the analysis of the chemical or physical characteristics, the performance, or the production characteristics of a chemical substance, a mixture containing the substance, or an article. It can include production of a chemical substance for use by others in their R&D activities. R&D activity generally includes specific monitored tests undertaken as part of a planned program of activity.

EPA is proposing an alternate exemption for the existing small manufacturer exemption. Under other TSCA section 8(a) rules, a company qualifies as a small manufacturer in 40 CFR 704.3 by meeting either of the following two standards. The first is that sales of the company are less than $40 million per year and the company does not manufacture more than 100,000 pounds annually of an individual substance at any individual site owned or controlled by the company. The second is that sales are less than $4 million regardless of the quantity manufactured.

EPA is proposing a different exemption for purposes of this rule by eliminating the first standard and defining a small manufacturer or processor as any company with sales of less than $4 million. The 100,000-pound threshold in the existing exemption did not contemplate typical production volumes for chemical substances manufactured at the nanoscale. EPA has reviewed over 200 chemical substances manufactured at the nanoscale in the NMSP and the new chemicals program under TSCA. At least 170 of those chemical substances manufactured at the nanoscale had reported or estimated production volumes less than 22,000 pounds. Based on this experience, exempting manufacturers or processors from reporting annual production volumes of up to 100,000 pounds would exclude a large proportion of companies that characteristically manufacture chemical substances manufactured at the nanoscale in small amounts but would not otherwise be considered small. Given that chemical substances manufactured at the nanoscale tend to be produced in small volumes, EPA does not believe production volume should be a relevant consideration in determining whether a nanotechnology company is a small manufacturer or processor. EPA requests comment on the proposed small manufacturer or processor exemption that would apply for this proposed rule.

4. Proposed exceptions to reporting. The proposed rule would not require manufacturers or processors to report certain information that has already been submitted to EPA. A person who submitted a TSCA chemical notice under section 5 to EPA on or after January 1, 2005 would not be required to report regarding the same substance under this proposed TSCA section 8(a) rule except where the person manufactured or processed a new discrete form of the reportable chemical substance. In addition, any person who has already reported part of or all of the information that would be required under this proposed TSCA section 8(a) rule under the NMSP would not need to report that information again under this proposed TSCA section 8(a) rule. If, however, information required by this proposed rule was not reported under section 5 or the NMSP (including information for each discrete form of a reportable chemical substance), then reporting of that information would be required under this proposed TSCA section 8(a) rule. The purpose of these exemptions is to avoid duplicative reporting. For example new chemical notices that have been reviewed as nanoscale materials would not be subject to reporting the same information under this rule.

EPA proposes that persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the final effective date of the rule would report to EPA six months after the final effective date of the rule. EPA also proposes a continuing requirement that persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule would report to EPA at least 135 days before commencement of manufacture or processing.

The 135-day period is based on EPA's experience with PMN submissions. TSCA section 8(a) applies to a person “who manufactures or processes or proposes to manufacture or process a chemical substance”. A company proposes to manufacture or process a chemical substance by forming the intent to do so. Based on EPA's experience, persons form the intent to manufacture or process chemical substances at least 135 days ahead of time. This belief is based on EPA's experience with Premanufacture Notice (PMN) submissions and subsequent notices of commencement (NOCs). Pursuant to section 5(a)(1) of TSCA and 40 CFR 720.22, PMNs are submitted by a person who intends to manufacture a chemical substance, at least 90 days before commencing manufacture. Under 40 CFR 720.102, a company that has submitted a PMN for which the statutory 90-day review period has expired and which has commenced manufacture of that substance must submit an NOC to EPA within 30 days following commencement. For fiscal years 2009-2011, EPA received 1,723 PMNs. Based on EPA's review of NOC receipt date information, EPA determined that NOCs were received within 45 days of completion of the 90-day PMN review for only 16% of these submitted PMNs. Thus, for 84% of the submitted PMNs, the intent to manufacture was formed at least 135 days (i.e., the 90-day PMN review period plus 45 days) before commercialization. Because a company must by necessity form the intent to manufacture a chemical substance some period of time before the PMN is submitted to EPA, the intent to manufacture or process would be made at least 135 days in advance as a general matter.

This TSCA section 8(a) rule proposes one-time reporting of certain information, including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data.

EPA developed an information reporting form for the NMSP (Ref. 27) which has been slightly modified for purposes of this proposed rule. The same information that was requested in the NMSP would be required by this proposed rule, including information on specific chemical identity, material characterization, physical chemical properties, production volume, use, methods of manufacturing and processing, exposure and release information, and existing data concerning the environmental and health effects. The information would be reported on a form similar to that used in the NMSP (Ref. 27). Any person required to report under this proposed rule would supply the information identified in the form to the extent it is known to or reasonably ascertainable by them. A draft of the proposed reporting form (EPA Form No. 7710-[tbd]) is available in the docket for public review (Ref. 28).

EPA is requesting comment on whether any information proposed to be collected requested in this proposed rule is duplicative of information collected under other federal statutes and, thus should be excluded. Please identify the statute and the information that you believe is duplicative.

EPA is proposing electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see proposed 704.20(e)). EPA is proposing to require submitters to use EPA's CDX, the Agency's electronic reporting portal, for all reporting under this rule. In 2013 (Ref. 1), EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). The final rule follows two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA Chemical Data Reporting and for Pre-Manufacture Notifications. In proposing to require similar electronic reporting under this rule, EPA intends to save time, improve data quality and increase efficiencies for both the submitters and the Agency.

EPA developed the Chemical Information Submission System (CISS) for use in submitting data for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. The tool is available for use with Windows, Macs, Linux, and UNIX based computers, using “Extensible Markup Language” (XML) specifications for efficient data transmission across the Internet. CISS, a web-based reporting tool, provides user-friendly navigation, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments, or by other electronic standards, such as XML.

EPA is proposing to require submitters to follow the same submission procedures used for other TSCA submissions, i.e., to register with EPA's CDX and use CISS to prepare a data file for submission. Registration enables CDX to authenticate identity and verify authorization. To submit electronically to EPA via CDX, individuals must first register with that system at http://cdx.epa.gov/epa_home.asp. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and organization, selects a user name and password, and follows the procedures outlined in the guidance document for CDX available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.

Users who have previously registered with CDX for other TSCA submissions, Chemical Data Reporting, or the Toxic Release Inventory TRI-ME web reporting flow, would be able to add the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow to their current registration, and use the CISS web-based reporting tool.

All submitters would be required to use CISS to prepare their submissions. CISS guides users through a “hands-on” process of creating an electronic submission. Once a user completes the relevant data fields, attaches appropriate PDF files, or other file types, such as XML files, and completes metadata information, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions on submitting voluntary submissions, such as under MOUs, are available, and instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information would be available through CISS reporting guidance.

CISS, a web-based reporting tool, also allows the user to choose “Print,” “Save,” or “Transmit through CDX.” When “Transmission through CDX” is selected, the user is asked to provide the user name and password that was created during the CDX registration process. CISS then encrypts the file and submits it via CDX. The user will login to the application and check the status of their submissions. Upon successful receipt of the submission by EPA, the status of the submissions will be flagged as “Completed.” The CDX inbox is currently used to notify the users of any correspondence related to user registration. Information on accessing the CDX user inbox is provided in the guidance document for CDX at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html. Procedures for reporting chemical substances under this proposed rule would be similar. EPA will put a version of the reporting tool in the docket for commenters, and is interested in feedback on the extent of and burden associated with training for using CDX.

EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization, and more easily save a copy for their records or future use. The resource and time requirements to review and process data by the Agency will also be reduced and document storage and retrieval will require fewer resources. EPA expects to benefit from receiving electronic submissions and communicating back electronically with submitters.

Any person submitting a reporting form could claim any part or all of the form as CBI. Any information which is claimed as confidential will be disclosed by EPA only to the extent and by the means of the procedures set forth in 40 CFR part 2.

A TSCA section 8(a) rule may require persons subject to the rule to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them, but may not require persons to develop test data for submission to the Agency. However, in view of the lack of information regarding chemical substances manufactured at the nanoscale, EPA would encourage respondents to this proposed rule to provide the Agency with any relevant data on chemical substances manufactured at the nanoscale they decide to develop.

Persons choosing to develop test data should provide data that conform to the Good Laboratory Practice Standards, which are codified at 40 CFR part 792. There are also standard test methods available for properties and information identified in the proposed rule from a number of sources. Some of these sources include but are not limited to ASTM International, the International Organization for Standardization, the National Institute of Standards and Technology, and the Organization for Economic Cooperation and Development. EPA encourages persons who intend to conduct testing to consult with the Agency before selecting a protocol for testing a chemical substance manufactured at the nanoscale. EPA would also encourage persons that would be required to submit TSCA section 8(a) data under this proposed rule to provide information on the potential benefits regarding the reportable chemical substance.

EPA is seeking public comment on all aspects of this proposed rule. In addition to specific requests for comment included throughout this document, EPA is interested in comments pertaining to the specific issues discussed in this unit. EPA also anticipates conducting a public meeting during the comment period to further discuss these and any other issues concerning the proposed rule.

1. Identifying the chemical substances that would be subject to reporting. EPA has developed the proposed approach based on the approximate size range of 1-100 nm as used by the NNI for defining nanotechnology (Ref. 6), experience in conducting assessments of new chemicals manufactured at the nanoscale by EPA under TSCA, and data submitted to EPA under the NMSP. EPA is soliciting comment on each aspect of the proposed approach to identifying the chemical substances that would be subject to the reporting requirements of the rule. The Agency is seeking comment on these approaches and alternative approaches for reporting requirements. For example the proposed rule would apply to reportable chemical substances that contain primary particles, aggregates, or agglomerates in the size range of 1-100 nm in at least one dimension. EPA is seeking comments on that aspect of reportable chemical substances. EPA is asking commenters if the current proposal sufficiently encompasses these types of reportable chemical substances.

2. Distinguishing between nanoscale forms of a reportable chemical substance. EPA considered several different approaches to distinguish between nanoscale forms of a reportable chemical substance including a percentage or numerical change in measured properties. The agency is also seeking comment on an approach based solely on the behavior of the reportable chemical substance. For example, if a manufacturer or processor knows about or engineers a reportable chemical substance with multiple nanoscale forms with different performance characteristics then each nanoscale form would be reported. If multiple nanoscale forms of a reportable chemical substance do not perform differently then only a single report of the entire range would be reported. EPA is seeking comment on these and other alternative approaches. EPA is especially interested in comments on whether these approaches would require reporting of sufficiently distinct nanoscale forms of a chemical substance so that reporting would be focused on those nanoscale forms with potential for significantly different physical or chemical characteristics or properties. EPA also seeks comment on each aspect of its proposed reporting such as size increments, the number of standard deviations, morphology, the specific physical-chemical properties identified, exclusions to reporting, and whether companies have the analytical tools to make such distinctions.

3. Reporting discrete forms at least 135 days before commencement of manufacture or processing. As discussed in Unit III.B., EPA proposed the 135-day period based on EPA's experience with PMN submissions, and the determination that the intent to manufacture was formed at least 135 days before commercialization (i.e., the 90-day PMN review period plus 45 days). EPA is specifically seeking comment on whether this time-period should be 135 days as proposed, 90 days to be similar to the PMN review period, or some other time period. It would be most helpful if commenters explain why the time period they suggest is appropriate.

4. Considerations for the Agency's economic analysis. EPA has evaluated the potential costs for manufacturers and processors of reportable chemical substances for this proposed rule (Ref. 3). EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis. In particular, data that could facilitate the Agency's further evaluation of the potentially affected industry and firms, including data related to potential impacts for those small businesses that would be subject to reporting. EPA is especially interested in available data or other measures of the number of and potential growth in the number of commercial nanoscale materials or firms that might manufacture or process such materials.

5. Electronic reporting. In proposing to require electronic reporting under this rule that is similar to those established in 2013 for other TSCA reporting, EPA intends to save time, improve data quality and increase efficiencies for both the submitters and the Agency. EPA is specifically interested in comments related to the adoption of the existing mechanisms and related procedures for use in transmitting the reports proposed in this rule, including comments related to the extent to which potentially reporting entities are already familiar with those mechanisms given their existing use for other TSCA reporting. EPA is also interested in feedback on how electronic reporting mechanisms affect reporting entities in terms of reporting time, added efficiencies, and potential burden associated with training to use the electronic systems (i.e., CDX and CISS).

6. Consideration of potential future rulemaking regarding periodic reporting. EPA is also seeking comment on the possibility of a future rule that would require periodic reporting of chemical substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data Reporting (CDR) rule at 40 CFR part 711. Such a rule could require manufacturers and processors of chemical substances manufactured at the nanoscale to report the type of information collected under the CDR rule to EPA at the same reporting interval as currently required by CDR reporting (every four years). That reporting could occur at lower thresholds for criteria such as production volume. The CDR is a program designed to collect screening-level, exposure-related information on chemical substances and to make that information available for use by EPA and to the public consistent with confidentiality under TSCA Section 14 and EPA regulations in 40 CFR part 2. The CDR rule data are used by EPA to support risk screening, assessment, priority setting and management activities and constitute the most comprehensive source of basic screening-level, exposure-related information on chemicals available to EPA. For further information see http://www.epa.gov/oppt/cdr.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these references and other information considered by EPA. For assistance in locating these other documents, please consult the technical contact listed under FOR FURTHER INFORMATION CONTACT.

The Office of Management and Budget (OMB) has designated this proposed rule as a “significant regulatory action” under section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this proposed rulemaking to OMB for review under Executive Order 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB comments have been documented in the public docket for this rulemaking as required by section 6(a)(3)(E) of Executive Order 12866.

An agency may not conduct or sponsor, and a person is not required to respond to an information collection request subject to the PRA, 44 U.S.C. 3501 et seq., unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and included on any related collection instrument (e.g., on the form or survey).

The information collection requirements in 40 CFR part 704 related to TSCA section 8(a) reporting rules have already been approved by OMB under the PRA. That information collection request (ICR) has been assigned EPA ICR No. 1198.10 and OMB Control No. 2070-0067. Because this proposed rule would involve revised information collection activities that require additional OMB approval, EPA has prepared an addendum to the currently approved ICR. The addendum, identified under EPA ICR No. 2517.01 and OMB Control No. 2070-NEW (Ref. 29), is available in the docket and is briefly summarized here.

If an entity were to submit a report to the Agency, the annual burden is estimated to average 137 hours per response. Burden is defined in 5 CFR 1320.3(b). As presented in the economic analyses and the ICR addenda, EPA estimates that the proposed TSCA section 8(a) rule would create an industry burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, EPA has established a docket for this proposed rule, which includes this ICR, under docket ID number EPA-HQ-OPPT-2010-0572. Submit any comments related to the ICR to EPA and OMB. See ADDRESSES for where to submit comments to EPA. Send comments to OMB via email to [email protected]. Address comments to OMB Desk Officer for EPA.

Since OMB is required to make a decision concerning the ICR between 30 and 60 days after April 6, 2015, a comment to OMB is best assured of having its full effect if OMB receives it by May 6, 2015. The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposed rule.

Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I hereby certify that this action would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is summarized here, and is presented in a small entity impact analysis that EPA prepared for this proposed action that is part of the Agency's economic analysis in the public docket for this proposed rule (Ref. 3).

Under the RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined as: (1) a small business, as defined by the Small Business Administration's (SBA) regulations 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. Since the regulated community is not expected to include small governmental jurisdictions or small not-for-profit organizations, the analysis focuses on small businesses.

A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 704.5(f). For this action, EPA is proposing to modify the exemption. EPA analyzed potential small business impacts from this proposed rule using both the SBA employee size standards and the TSCA sales-based definition of small business. EPA estimates that up to 174 small businesses may be impacted by the proposed TSCA section 8(a) reporting rule and evaluated the number that may incur costs at below 1%, between 1% and 3%, and above 3% of sales. EPA estimates that all 174 small businesses identified would incur costs below 1% of sales.

EPA continues to be interested in the potential impacts of this proposed rule on small entities that are not exempt from reporting and welcomes comments on issues related to such impacts.

Based on EPA's experience with proposing and finalizing rules under TSCA section 8(a), State, local and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local or Tribal government would be impacted by this rulemaking. In addition, this action will not result in annual expenditures of $100 million or more for the private sector. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments, and that the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

This action does 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 (64 FR 43255, August 10, 1999).

This action does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000).

EPA interprets Executive Order 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 Executive Order 13045 has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. Nevertheless, the information obtained by the reporting required by this proposed rule will be used to inform the Agency's decision-making process regarding chemical substances to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemical substances addressed in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use.

Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This action does not affect the level of protection provided to human health or the environment.

This action does not affect the level of protection provided to human health or the environment. However, the Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with various chemicals manufactured processed, and used at the nanoscale. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority communities.

Therefore, 40 CFR chapter I is proposed to be amended as follows:

This is a summary of the Bureau's Order in PS Docket Nos. 14-193 and 13-75, DA 15-299, adopted and released on March 6, 2015, and pertaining to the proposed rule published January 22, 2015 (80 FR 3191). The complete text of this document is available for public inspection and copying from 8 a.m. to 4:30 p.m. ET Monday through Thursday or from 8 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The complete text is also available on the Commission's Web site at http://transition.fcc.gov/Daily_Releases/Daily_Business/2015/db0306/DA-15-299A1.pdf, or by using the search function on the ECFS Web page at http://www.fcc.gov/cgb/ecfs/.

The Bureau released an Order on March 6, 2015, which extends the comment and reply comment filing deadlines for the 911 Governance NPRM, 80 FR 3191, January 22, 2015. The Order responded to a joint petition by the Association for Telecommunications Industry Solutions (ATIS); the Association of Public Safety Communications Officials International (APCO); the Industry Council for Emergency Response Technologies (iCERT); the National Association of State 911 Administrators (NASNA); the National Emergency Number Association (NENA); and the United States Telecom Association (USTA) seeking an extension of the comment period. Pursuant to sections 4(i) of the Communications Act of 1934, as amended, and pursuant to the authority delegated in 47 CFR 0.191, 0.392, and 1.46, the Bureau extended the deadline for filing comments until March 23, 2015, and extends the deadline for reply comments until April 21, 2015.

Background

On September 18, 2014, we received a petition from the Natural Resources Defense Council to list the Gulf of Mexico population of Bryde's whale (Balaenoptera edeni) as an endangered DPS under the ESA. Supporting information in the form of bibliographic references, reprints of pertinent publications, copies of reports or letters from authorities, and maps as required by 50 CFR 424.14(b)(2)(iv) was not included in the petition. We requested those materials on October 10, 2014, and on October 21, 2014, we received some materials. We made a second request for outstanding information on November 26, 2014, and received materials the same day. Copies of this petition are available from us (see ADDRESSES, above) and can be found at http://sero.nmfs.noaa.gov/protected_resources/listing_petitions/index.html

Section 4(b)(3)(A) of the ESA of 1973, as amended (U.S.C. 1531 et seq.), requires, to the maximum extent practicable, that within 90 days of receipt of a petition to list a species as threatened or endangered, the Secretary of Commerce make a finding on whether that petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted, and to promptly publish such finding in the Federal Register (16 U.S.C. 1533(b)(3)(A)). When we find that substantial scientific or commercial information in a petition indicates the petitioned action may be warranted (a “positive 90-day finding”), we are required to promptly commence a review of the status of the species concerned during which we will conduct a comprehensive review of the best available scientific and commercial information. In such cases, we are to conclude the review with a finding as to whether, in fact, the petitioned action is warranted within 12 months of receipt of the petition. Because the finding at the 12-month stage is based on a more thorough review of the available information, as compared to the narrow scope of review at the 90-day stage, a “may be warranted” finding does not prejudge the outcome of the status review.

Under the ESA a listing determination addresses a “species,” which is defined to also include subspecies and, for any vertebrate species, any DPS that interbreeds when mature (16 U.S.C. 1532(16)). A joint NMFS-U.S. Fish and Wildlife Service (USFWS) policy clarifies the agencies' interpretation of the phrase “distinct population segment” for the purposes of listing, delisting, and reclassifying a species under the ESA (“DPS Policy”; 61 FR 4722; February 7, 1996). A species, subspecies, or DPS is “endangered” if it is in danger of extinction throughout all or a significant portion of its range, and “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range (ESA sections 3(6) and 3(20), respectively; 16 U.S.C. 1532(6) and (20)). Pursuant to the ESA and our implementing regulations, we determine whether species are threatened or endangered because of any one or a combination of the following ESA section 4(a)(1) factors: The present or threatened destruction, modification, or curtailment of habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; inadequacy of existing regulatory mechanisms; and any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1), 50 CFR 424.11(c)).

ESA-implementing regulations issued jointly by NMFS and USFWS (50 CFR 424.14(b)) define “substantial information” in the context of reviewing a petition to list, delist, or reclassify a species as the amount of information that would lead a reasonable person to believe that the measure proposed in the petition may be warranted. When evaluating whether substantial information is contained in a petition, the Secretary must consider whether the petition: (1) Clearly indicates the administrative measure recommended and gives the scientific and any common name of the species involved; (2) contains detailed narrative justification for the recommended measure, describing, based on available information, past and present numbers and distribution of the species involved and any threats faced by the species; (3) provides information regarding the status of the species over all or a significant portion of its range; and (4) is accompanied by the appropriate supporting documentation in the form of bibliographic references, reprints of pertinent publications, copies of reports or letters from authorities, and maps (50 CFR 424.14(b)(2)).

Court decisions clarify the appropriate scope and limitations of the NMFS' review of petitions at the 90-day finding stage, in making a determination whether a petitioned action “may be warranted.” As a general matter, these decisions hold that a petition need not establish a “strong likelihood” or a “high probability” that a species is either threatened or endangered to support a positive 90-day finding.

We evaluate the petitioner's request based upon the information in the petition, including its references, and the information readily available in our files. We do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We will accept the petitioner's sources and characterizations of the information presented, if they appear to be based on accepted scientific principles, unless we have specific information in our files that indicates the petition's information is incorrect, unreliable, obsolete, or otherwise irrelevant to the requested action. Information that is susceptible to more than one interpretation or that is contradicted by other available information will not be dismissed at the 90-day finding stage, so long as it is reliable and a reasonable person would conclude it supports the petitioner's assertions. In other words, conclusive information indicating the species may meet the ESA's requirements for listing is not required to make a positive 90-day finding. We will not conclude that a lack of specific information alone negates a positive 90-day finding, if a reasonable person would conclude that the unknown information itself suggests an extinction risk of concern for the species at issue.

To make a 90-day finding on a petition to list a species, we evaluate whether the petition presents substantial scientific or commercial information indicating the subject species may be either threatened or endangered, as defined by the ESA. First, we evaluate whether the information presented in the petition, along with the information readily available in our files, indicates that the petitioned entity constitutes a “species” eligible for listing under the ESA. Next, we evaluate whether the information indicates that the species at issue faces extinction risk that is cause for concern; this may be indicated in information expressly discussing the species' status and trends, or in information describing impacts and threats to the species. We evaluate any information on specific demographic factors pertinent to evaluating extinction risk for the species at issue (e.g., population abundance and trends, productivity, spatial structure, age structure, sex ratio, diversity, current and historical range, habitat integrity or fragmentation), and the potential contribution of identified demographic risks to extinction risk for the species. We then evaluate the potential links between these demographic risks and the causative impacts and threats identified in section 4(a)(1).

Information presented on impacts or threats should be specific to the species and should reasonably suggest that one or more of these factors may be operative threats that act or have acted on the species to the point that it may warrant protection under the ESA. Broad statements about generalized threats to the species, or identification of factors that could negatively impact a species, do not constitute substantial information that listing may be warranted. We look for information indicating that not only is the particular species exposed to a factor, but that the species may be responding in a negative fashion; then we assess the potential significance of that negative response.

We have determined, based on the information provided in the petition and readily available in our files, that substantial information is presented in the petition indicating that the petitioned action may be warranted. The petition contains a recommended administrative measure, provides the scientific and common name, contains a detailed narrative justification for the recommended measure, provides information on the status of the species, and includes supporting documentation. Below is a synopsis of our analysis of the information provided in the petition and readily available in our files.

The Bryde's whale (Balaenoptera edeni) is a baleen whale, more specifically a rorqual, belonging to the same group as the blue whale and the humpback whale. They are distributed around the tropical waters of the world between 40°N and 40°S, or in waters warmer than 16.3°C (Kato, 2002). The Bryde's whale is represented by two subspecies: B. e. edeni and B. e. brydei. The generally larger form (14-15 m in length), B. e. brydei or “ordinary Bryde's whale,” is found in temperate and tropical waters within the Atlantic, Pacific, and Indian Oceans, with a somewhat smaller inshore group found in coastal South Africa. The smaller form (rarely exceeding 11.5m in length), B. e. edeni, has been found only in the Western Pacific, in waters off Asia and possibly Australia. Two other species, the sei whale (B. borealis) and the Omura's whale (B. omurai), are closely related to the Bryde's whale and often considered part of the Bryde's whale “complex” (Wada et al., 2003; Sasaki et al., 2006). Here the term “Bryde's whale” refers to B. edeni and its subspecies (B. e. edeni and B. e. brydei).

Like other rorquals, the Bryde's whale has twin blowholes behind a protruding ridge and two rows of baleen plates instead of teeth. Good descriptions of the Bryde's whale can be found in Olsen (1913) and Best (1977). These reports note that the Bryde's whale is dark smoky-gray dorsally and usually white ventrally. It is elongated, with a small, curved dorsal fin, and slender, pointed flippers. These flippers are bluish-black dorsally, grey ventrally and can reach approximately 10 percent of the total length of the animal. The throat area is dark bluish-grey, with 42-54 ventral grooves or furrows that extend back at least to the umbilicus. It has around 280 (ranging between 255 and 365) relatively stiff baleen plates of up to 0.5 m in length on each side of the mouth. Each plate has very coarse bristles forming a “bush” at the top. A median groove extending from the umbilicus to the genital aperture is typically present.

Bryde's whales are generally found in a range of habitats and water depths. Their distribution in the Gulf of Mexico appears highly limited to a relatively small area off the Florida Panhandle along the shelf edge in DeSoto Canyon at depths between 100 and 1,000 m (e.g., Mullin and Fulling, 2004; Širović et al., 2014). There have been no confirmed records of Bryde's whales from the Gulf of Mexico outside the U.S. Exclusive Economic Zone (EEZ), but it cannot be ruled out that the whales move outside this small area, including into the waters off Cuba or Mexico; the U.S. EEZ only makes up 35 percent of the oceanic waters of the Gulf of Mexico (NMFS, 2013).

The petitioner presented information on the status of the population of the Gulf of Mexico Bryde's whale, and additional information was also available in our files. There have been four point estimates of population size made since 1991 for the northern Gulf of Mexico (i.e., within the U.S. EEZ only). The best abundance estimate for the Gulf of Mexico Bryde's whale is 33 (Coefficient of Variation [CV] = 1.07) from a summer 2009 oceanic survey, with a minimum population estimate of 16 whales (NMFS, 2012). This estimate is below the 35 animals (CV = 1.10) for the 1991 to 1994 period (Hansen et al., 1995) and the 40 animals (CV = 0.61) estimated for the 1996 to 2001 period (Mullin and Fulling, 2004), and greater than the estimate for 2003 to 2004, which was 15 animals (CV = 1.98) (Mullin, 2007). While there have been four point estimates made, the precision of the estimates is poor, there is no statistical difference between the maximum and minimum estimates (NMFS, 2009), and no interpretation of population trends should be made from these values. NMFS (2009) further cautions that the available estimates, based on surveys conducted only in the U.S. EEZ, cannot account for changes in abundance from shifts in distribution beyond U.S. waters, and NMFS (2012) recommends that Bryde's whales need to be satellite tagged to determine whether they use the northeastern Gulf exclusively or travel to other areas.

The petition requests that we designate Bryde's whales in the Gulf of Mexico as an endangered DPS and presents arguments that Bryde's whales in the Gulf of Mexico meet NMFS and the U.S. Fish and Wildlife Service's (together, the Services) requirements for identifying a DPS eligible for listing. Our DPS policy identifies two elements that must be considered when identifying a DPS: (1) The discreteness of the population segment in relation to the remainder of the species (or subspecies) to which it belongs; and (2) the significance of the population segment to the species to which it belongs. A population segment of a vertebrate species may be considered discrete if it satisfies either one of the following conditions: (1) It is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors—quantitative measures of genetic or morphological discontinuity may provide evidence of this separation; or (2) it is delimited by international governmental boundaries within which differences in control of exploitation, management of habitat conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D) of the ESA. If a population segment is considered discrete under one or more of the above conditions, its biological and ecological significance will then be considered in light of Congressional guidance (see Senate Report 151, 96th Congress, 1stSession) that the authority to list DPSs be used “sparingly” while encouraging the conservation of genetic diversity. In carrying out this examination, the Services will consider available scientific evidence of the discrete population segment's importance to the taxon to which it belongs. This consideration may include, but is not limited to, the following: (1) Persistence of the discrete population segment in an ecological setting unusual or unique for the taxon; (2) evidence that loss of the discrete population segment would result in a significant gap in the range of a taxon; (3) evidence that the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historic range; or (4) evidence that the discrete population segment differs markedly from other populations of the species in its genetic characteristics.

The petitioner asserts that genetic and morphological information is evidence the Gulf of Mexico Bryde's whale population qualifies as a distinct population segment under the ESA. The petition cites Rosel and Wilcox (2014) as evidence the Gulf of Mexico Bryde's whale population is as evolutionarily distinct as other recognized subspecies within the Bryde's whale complex. The petition also includes information indicating those whales in the Gulf of Mexico are residents and may be geographically isolated from other Bryde's whales. Analyzing DNA sequence data from three mitochondrial DNA and nine nuclear genes, and examining 42 nuclear microsatellite loci for 21 Bryde's whale samples, Rosel and Wilcox (2014) found that “Gulf of Mexico Bryde's whale haplotypes are evolutionarily distinct from other members of the Bryde's whale complex.” Further, Rosel and Wilcox (2014) found that Gulf of Mexico Bryde's whales are as divergent as the two already recognized subspecies of Bryde's whales. Rosel and Wilcox (2014) also stated that the divergence is as great as two species generally are from one another, thus we find that the petition presents substantial evidence that the DPS policy's criteria for discreteness may be met for the Gulf of Mexico Bryde's whale.

The petitioner also argues that the Bryde's whale in the Gulf of Mexico is significant because of its unique genetic characteristics, its behavior and morphology, and because it is the only resident baleen whale population in the Gulf of Mexico. The petitioners cite the findings of Rosel and Wilcox (2014) and state the genetic differentiation shown by the Gulf of Mexico Bryde's whale makes it evolutionarily significant. The petitioners also argue that the Gulf of Mexico Bryde's whale is behaviorally and morphologically different from other Bryde's whales. Behaviorally, the Gulf of Mexico Bryde's whales use a call that differs in frequency and repetitive structure from variants used in other Bryde's whale populations (Širović et al., 2014; Rice et al., 2014). Morphologically, the Gulf of Mexico Bryde's whales' body lengths seem intermediary to the smaller B. e. edeni and larger B. e. brydei forms (Best, 1977; Rice, 1998). The petitioner also states that as the only resident baleen whale in the Gulf of Mexico, the Bryde's whale fills a unique ecological niche. We therefore conclude that the petition presents sufficient evidence that the DPS policy's criteria for significance may be met for the Gulf of Mexico Bryde's whale. Because the Gulf of Mexico population of Bryde's whale may qualify as a DPS, we will consider it a potentially listable entity for purposes of this 90-day finding. Whether the Gulf of Mexico population of Bryde's whales constitutes a DPS will receive further analysis in the status review.

The petitioner states the Gulf of Mexico Bryde's whale is threatened by three (out of five) ESA Section 4(a)(1) factors: present or threatened destruction, modification, or curtailment of its habitat or range; inadequacy of existing regulatory mechanisms; and other natural or manmade factors affecting its continued existence. The petition cites the following threats as contributing to the present or threatened destruction, modification, or curtailment of habitat or range of the Gulf of Mexico Bryde's whale: (1) Ship strikes, (2) acoustic impacts, (3) oil spills, (4) other toxic chemicals, (5) ocean acidification, (6) entanglement in fishing gear, and (7) trophic impacts due to overfishing. We believe that three of these threats (numbers 1, 6, and 7) should be categorized under the Section 4(a)(1) category “other natural or manmade factors.”

Ship strikes are a recognized source of whale mortality (Laist et al., 2006). In 2009, a Bryde's whale was struck by a ship near Tampa, Florida (Waring et al., 2013); additionally, eight other Bryde's whales are known to have stranded along the U.S. coast of the Gulf of Mexico between 1975 and 1996, from unknown causes (Laist, 2001). While ship collisions probably have a negligible effect on the status and trend of most whale populations, they may have a significant effect on very small populations or discrete groups (Laist et al., 2001), such as the Gulf of Mexico population of Bryde's whale. The petition also states that ship-strike risk in the Gulf of Mexico may increase in the near future given expansion of the Panama Canal and the associated increase in vessel traffic. There was one documented, lethal ship strike of a Bryde's whale in 2009, involving a lactating female (therefore, its calf presumably ultimately died as well). Detected mortalities are a minimum estimate and almost certainly biased low. Total human-caused mortality of the northern Gulf of Mexico Bryde's whale stock is unknown, but, based on the 2009 confirmed mortality and the stock's small size, the annual human-caused mortality to the stock is greater than the stock's potential biological removal level (NMFS, 2012), meaning that the level of mortality threatens the stock's ability to achieve and maintain its optimum sustainable population. After reviewing the references and information in our files, we agree that, given the small population size, injury and death from ship strikes may be impacting Gulf of Mexico Bryde's whale to a degree that raises concerns regarding the risk of extinction.

The petition cites numerous sources detailing negative effects of acoustic impacts on marine mammals, including hearing loss, masking of biologically significant sounds, and disruption in foraging and other vital behaviors (NRC, 2003; Weilgart, 2007; CBD, 2012). The petition cites Azzara et al. (2013) to indicate that Gulf of Mexico shipping traffic may be disrupting sperm whale behavior and possibly communication and foraging patterns. The petition indicates the calls of Bryde's whale fall well within the range of commercial shipping noise (5 to 500 Hz [Hildebrand, 2009]) and concludes that the high levels of ambient noise in the Gulf of Mexico are likely to constrain the communication range of Bryde's whales, citing Hatch et al. (2012), and may potentially induce a chronic stress response, citing Rolland et al. (2012).

The petition also cites seismic exploration using airguns as a threat that would degrade Bryde's whale communication, based on the frequency overlap between Bryde's whale calls and the peak energy release of the airguns. Based on reports from other baleen whale species (e.g., Clark and Gagnon, 2006; Gailey et al., 2007; Di Iorio and Clark, 2010; Castellote et al., 2012; Blackwell et al., 2013; Cerchio et al., 2014), the petition suggests that seismic noise may, in addition to masking communication, directly disrupt other behaviors of Bryde's whales. When we conduct 90-day reviews of petitions, we typically look for species-specific information that a threat is operative. In this case, considering the information presented on other large cetaceans, the ubiquity of major noise-producing sources in the Gulf of Mexico, and the apparently constrained habitat of Bryde's whales, we find that there is sufficient information presented to suggest that acoustic impacts may be an operative threat to this species, despite the lack of information specific to Bryde's whales. After reviewing the information in the petition, we conclude that commercial and industrial ocean noise may be negatively affecting Gulf of Mexico Bryde's whale behavior, physiology, and acoustic habitat to a degree that raises concerns regarding the risk of extinction.

Based on the above information and the criteria specified in 50 CFR 424.14(b)(2), we find substantial information was presented on the “present or threatened destruction, modification, or curtailment of its habitat or range” (i.e., acoustic impacts) and on “other natural or manmade factors” (i.e., ship strikes) indicating the petitioned action of listing the Gulf of Mexico Bryde's whale (B. e. edeni) as an endangered DPS may be warranted. Since we determined that the threats associated with acoustic impacts and ship strikes indicate that the petitioned action may be warranted, we did not conduct a detailed analysis of the other threats cited by the petitioner here.

Because we have found that substantial information was presented to indicate the petitioned action may be warranted, we will commence a status review of the species. During our status review, we will fully address all five of the factors set out in Section 4(a)(1). At the conclusion of the status review, we will determine whether the petitioned action is warranted. As previously noted, a “may be warranted” finding does not prejudge the outcome of the status review.

As required by section 4(b)(3)(B) of the ESA and NMFS' implementing regulations (50 CFR 424.14(b)(2)), we are to commence a review of the status of the species and make a determination within 12 months of receiving the petition as to whether the petitioned action is warranted. We intend that any final action resulting from this review be as accurate and as effective as possible. Therefore, we open a 60-day public comment period to solicit information from the public, government agencies, the scientific community, industry, and any other interested parties on the delineation of, threats to, and status of the Gulf of Mexico Bryde's whale including: (1) Historical and current distribution, abundance, and population trends; (2) life history and biological information including adaptations to ecological settings, genetic analyses to assess paternal contribution and population connectivity, and movement patterns to determine population mixing; (3) management measures and regulatory mechanisms designed to protect the species; (4) any current or planned activities that may adversely impact the species; and (5) ongoing or planned efforts to protect and restore the species and habitat. We request that all information be accompanied by: (1) Supporting documentation such as maps, bibliographic references, or reprints of pertinent publications; and (2) the submitter's name, address, and any association, institution, or business that the person represents. Section 4(b)(1)(A) of the ESA and NMFS' implementing regulations (50 CFR 424.11(b)) require that a listing determination be made solely on the basis of the best scientific and commercial data, without consideration of possible economic or other impacts of the determination. During the 60-day public comment period we are seeking information related only to the status of the Gulf of Mexico Bryde's whale.

A complete list of references is available upon request from the Southeast Regional Office, Protected Resource Division (see ADDRESSES).

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

Background

On September 24, 2014, we received a petition from Dr. Michael J. Dadswell, Dr. Matthew K. Litvak, and Mr. Jonathan Barry regarding the population of shortnose sturgeon (Acipenser brevirostrum) native to the Saint John River in New Brunswick, Canada. The petition requests that we identify the Saint John River population of shortnose sturgeon as a distinct population segment (DPS) and contemporaneously delist this DPS from the Endangered Species Act.

Acipenser brevirostrum was originally listed as an endangered species throughout its range by the U.S. Fish and Wildlife Service (USFWS) on March 11, 1967, under the Endangered Species Preservation Act (ESPA, 32 FR 4001). Shortnose sturgeon remained on the endangered species list when the U.S. Congress replaced ESPA by enacting the Endangered Species Conservation Act of 1969, which was in turn replaced by the Endangered Species Act of 1973 (ESA, 16 U.S.C. 1531 et seq.). NMFS subsequently assumed jurisdiction for shortnose sturgeon under a 1974 government reorganization plan (39 FR 41370, November 27, 1974). In Canada, the shortnose sturgeon falls under the jurisdiction of the Department of Fisheries and Oceans (DFO) and was listed as a species of “special concern” under the Species at Risk Act (SARA) in 1980. The status under SARA was maintained following a 2005 assessment (COSEWIC 2005). Shortnose sturgeon is also listed under Appendix I of the Convention on International Trade in Endangered Species of Wild Fauna (CITES).

Section 4(b)(3)(A) of the ESA of 1973, as amended (U.S.C. 1531 et seq.), requires, to the maximum extent practicable, that within 90 days of receipt of a petition to list a species as threatened or endangered, the Secretary of Commerce make a finding on whether that petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted, and to promptly publish the finding in the Federal Register (16 U.S.C. 1533(b)(3)(A)). When we find that substantial scientific or commercial information in a petition indicates that the petitioned action may be warranted (a “positive initial finding” or “positive 90-day finding”), we are required to promptly commence a review of the status of the species concerned, which includes conducting a comprehensive review of the best available scientific and commercial information. Within 12 months of receiving the petition, we must conclude the review with a finding as to whether, in fact, the petitioned action is warranted (50 CFR 424.14(b)(3)). Because the finding at the 12-month stage is based on a significantly more thorough review of the available information, a “may be warranted” finding at this stage does not prejudge the outcome of the status review.

Under the ESA, a listing determination may address a “species,” which is defined to also include subspecies and, for any vertebrate species, any distinct population segment that interbreeds when mature (16 U.S.C. 1532(16)). A joint policy issued by NMFS and the U.S. Fish and Wildlife Service (USFWS) clarifies the interpretation of the phrase “distinct population segment,” or DPS for the purposes of listing, delisting, and reclassifying a species under the ESA (“DPS Policy,” 61 FR 4722, February 7, 1996). The DPS Policy identifies two criteria for determining whether a population is a DPS: (1) The population must be “discrete” in relation to the remainder of the taxon (species or subspecies) to which it belongs; and (2) the population must be “significant” to the remainder of the taxon to which it belongs. Congress has instructed the Secretary to exercise authority to recognize DPS's “ * * * sparingly and only when the biological evidence indicates that such action is warranted.” (Senate Report 151, 96th Congress, 1st Session). In a recent decision, the United States District Court for the District of Columbia held that the ESA does not permit identification of a DPS solely for purposes of delisting. See Humane Soc'y v. Jewell, No. 13-186 (BAH), − F.3d. −, 2014 WL7237702 (D.D.C. December 19, 2014) (Western Great Lakes gray wolves). Because this is a single district court decision and may be appealed, we conclude it does not compel us to deny the present petition; however, we note that it highlights potential complications associated with the petitioned action.

A species, subspecies, or DPS is “endangered” if it is in danger of extinction throughout all or a significant portion of its range, and “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range (ESA sections 3(6) and 3(20), respectively, 16 U.S.C. 1532(6) and (20)). Pursuant to the ESA and our implementing regulations, the determination of whether a species is threatened or endangered shall be based on any one or a combination of the following five section 4(a)(1) factors: The present or threatened destruction, modification, or curtailment of habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; inadequacy of existing regulatory mechanisms; and any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1); 50 CFR 424.11(c)).

Under section 4(a)(1) of the ESA and the implementing regulations at 50 CFR 424.11(d), a species shall be removed from the list if the Secretary of Commerce determines, based on the best scientific and commercial data available after conducting a review of the species' status, that the species is no longer threatened or endangered because of one or a combination of the section 4(a)(1) factors. The regulations provide that a species listed under the ESA may be delisted only if such data substantiate that it is neither endangered nor threatened for one or more of the following reasons:

(1) Extinction. Unless all individuals of the listed species had been previously identified and located, and were later found to be extirpated from their previous range, a sufficient period of time must be allowed before delisting to indicate clearly that the species is extinct.

(2) Recovery. The principal goal of the USFWS and NMFS is to return listed species to a point at which protection under the ESA is no longer required. A species may be delisted on the basis of recovery only if the best scientific and commercial data available indicate that it is no longer endangered or threatened.

(3) Original data for classification in error. Subsequent investigations may show that the best scientific or commercial data available when the species was listed, or the interpretation of such data, were in error (50 CFR 424.11(d)).

A determination whether to revise a species-level listing to recognize one or more DPSs in place of a species-level listing involves a judgment as to which approach for managing the species best furthers the purposes of the ESA. We will make that determination prior to making a final finding on the petition.

At the initial finding stage on a petition to list, delist, or reclassify a species, the statute requires that we determine whether the petition has presented substantial scientific or commercial information indicating that the petitioned action may be warranted. See ESA section 4(b)(3)(A) (16 U.S.C. 1533(b)(3)(A)). ESA-implementing regulations issued jointly by NMFS and the USFWS (50 CFR 424.14(b)(1)) define “substantial information” as the amount of information that would lead a reasonable person to believe that the measure proposed in the petition may be warranted. When evaluating whether substantial information is contained in a petition, we must consider whether the petition: (1) Clearly indicates the administrative measure recommended and gives the scientific and any common name of the species involved; (2) contains detailed narrative justification for the recommended measure, describing, based on available information, past and present numbers and distribution of the species involved and any threats faced by the species; (3) provides information regarding the status of the species over all or a significant portion of its range; and (4) is accompanied by the appropriate supporting documentation in the form of bibliographic references, reprints of pertinent publications, copies of reports or letters from authorities, and maps (50 CFR 424.14(b)(2)).

At the initial finding stage, we evaluate the petitioner's request based upon the information in the petition, including references provided, and the information readily available in our files. We do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We will accept the petitioner's sources and characterizations of the information presented if they appear to be based on accepted scientific principles, unless we have specific information in our files which indicates that the petition's information is incorrect, unreliable, obsolete, or otherwise irrelevant to the requested action. Information that is susceptible to more than one interpretation or that is contradicted by other available information will not be dismissed at the initial finding stage, so long as it is reliable and a reasonable person would conclude that it supports the petitioner's assertions. In other words, conclusive information indicating that the species may meet the ESA's requirements for listing is not required to make a positive initial finding.

Many petitions identify risk classifications made by other organizations, such as the International Union for Conservation of Nature (IUCN), the American Fisheries Society, or NatureServe, as evidence of extinction risk for a species. Risk classifications by other organizations or made under other Federal or state statutes may be informative, but such classification alone may not provide the rationale for making an initial finding under the ESA. For example, as explained by NatureServe, their assessments of a species' conservation status do “not constitute a recommendation by NatureServe for listing under the U.S. Endangered Species Act” because NatureServe assessments “have different criteria, evidence requirements, purposes and taxonomic coverage than government lists of endangered and threatened species, and therefore these two types of lists should not be expected to coincide” (http://www.natureserve.org/prodServices/statusAssessment.jsp). Thus, when a petition cites such classifications, we will evaluate the source of information that the classification is based upon in light of the standards of the ESA and our policies as described above.

The shortnose sturgeon is a bony fish (Class Osteichthyes) that retains many primitive physical characteristics that reflect its ancient lineage. Distinctive features include a protective armor of bony plates called “scutes” that extend longitudinally from the base of the skull to the caudal peduncle; a subterminal, protractile tube-like mouth; and chemosensory barbels. The general body shape is cylindrical, tapering at the head and caudal peduncle, and the upper lobe of the tail is longer than lower lobe. Shortnose sturgeon vary in color but are generally dark brown to olive or black on the dorsal surface, lighter along the row of lateral scutes, and nearly white on the ventral surface. Adults have no teeth but possess bony plates in the esophagus that are used to crush hard prey items (Vladykov and Greeley 1963; Gilbert 1989). The skeleton is almost entirely cartilaginous with the exception of some bones in the skull, jaw and pectoral girdle. Maximum reported length is 1.43 m (total length, TL) and maximum reported weight is 23 kg (Dadswell 1984). Growth rates and maximum size display clinal variation, with the fastest growth rates and smallest maximum sizes occurring in southern populations. Shortnose sturgeon are benthic feeders, and their diet typically consists of small insects, crustaceans, mollusks, polychaetes, and small benthic fishes (McCleave et al. 1977; Dadswell 1979; Marchette and Smiley 1982; Dadswell et al. 1984; Moser and Ross 1995; Kynard et al. 2000; Collins et al. 2002).

Shortnose sturgeon occur along the East Coast of North America in rivers, estuaries, and marine waters. The current species' range is thought to extend from the Saint John River in New Brunswick, Canada, south to the St. Johns River, Florida (NMFS 1998). Shortnose sturgeon are “anadromous,” meaning they are born in freshwater, migrate to the ocean, then migrate back into freshwater as adults to spawn. However, some shortnose sturgeon populations rarely leave their natal river or associated estuary.

Shortnose sturgeon are relatively long-lived and slow to mature. Female sturgeon can live up to 67 years, but males seldom exceed 30 years of age. Males and females mature at about the same length, around 1.5-1.8 feet (45-55 cm), throughout their range. However, age at maturity varies across the range due the clinal variation in growth rates. Shortnose sturgeon also exhibit sexually dimorphic growth patterns across latitude: males mature at 2-3 years in Georgia and at 10-11 years in the Saint John River; females mature at 4-5 years in Georgia and at 12-18 years in the Saint John River (NMFS 2010). In general, males are thought to spawn every other year, but may spawn annually in some rivers (Kieffer and Kynard 1996; NMFS 1998). Females appear to spawn less frequently—approximately every three years to five years (Dadswell 1979).

The petition requests that we identify the Saint John River shortnose sturgeon (SJRSS) as a DPS and make a finding that this DPS does not meet the definition of threatened or endangered under the ESA. In effect, the petition requests the delisting of the SJRSS, which is currently part of the range-wide listing of shortnose sturgeon at the taxonomic level of species. The administrative actions requested in the petition are clear, and the petition is supported by a detailed narrative justification and appropriate references. The petition provides information regarding the status of, and threats to, the SJRSS. The petition does not request any DPS delineations or change in ESA status for the remainder of the species, and does not provide a discussion of the abundance, distribution, status or threats to shortnose sturgeon within the U.S. portion of the species' range. The Petitioners state that while they understand their petition may “trigger a range-wide status review of shortnose sturgeon,” they “respectfully request that the designation of the SJRSS population be treated independently and published on its own merits and schedule.”

As stated previously, to be considered a DPS, a population must be both discrete from other populations of the species and significant to the species as a whole (61 FR 4722, February 7, 1996). Under the DPS Policy, a population may be considered “discrete” if it satisfies either one of the following conditions:

(1) It is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors. Quantitative measures of genetic or morphological discontinuity may provide evidence of this separation.

(2) It is delimited by international governmental boundaries within which differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D) of the ESA.

The petition states that the SJRSS is markedly separated from other populations as a result of “geography, range, and physical constraints.” The petition does not specify, nor are we aware of, any “physical constraints” that preclude mixing of the Saint John River (SJR) population with other populations. However, the petition and references in our files suggest that there is no, or only limited, spatial overlap in the range of shortnose sturgeon from the SJR and rivers just to the south in Maine (e.g., Kennnebec, Androscoggin and Penobscot rivers). Separation of the SJR population from other shortnose populations is also supported by genetic data, which indicate limited interbreeding among some river populations. For example, Wirgin et al. (2009) assessed genetic differentiation among shortnose sturgeon from 14 river systems by comparing frequencies of mitochondrial DNA (mtDNA) control region haplotypes. The results of this analysis indicate that although 6 of 8 haplotypes in the SJR sample (N= 42 fish) are shared with other Gulf of Maine river samples, the SJR sample has significantly different haplotype frequencies than the other Gulf of Maine rivers (Wirgin et al. 2009). Female-mediated gene flow between the Penobscot River and the Saint John River was also estimated to occur at a low rate—only about 2 migrants per generation (Wirgin et al. 2009). A more recent study by King et al. (2014) using nuclear DNA provides additional indication that the SJRSS may be discrete from other river populations. King et al. (2014) used multiple approaches (principle component analysis and Bayesian clustering) to analyze data for 11 microsatellite loci for shortnose sturgeon from 17 sample populations (N= 561 total fish), including 25 fish from the SJR. The results suggest the existence of three metapopulations (Northeast, Mid-Atlantic, and South Atlantic), each with a different degree of genetic sub-structuring. The Northeast metapopulation, which encompasses the Merrimack, Androscoggin, Kennebec, Penobscot and Saint John rivers, was shown to have a moderate degree of differentiation into three groups: Merrimack, Androscoggin/Kennebec/Penobscot, and Saint John River. Estimates of the effective number of migrants per generation were very low among the three metapopulations (average ranged between 0.89-1.89), but were much higher within each metapopulation. For the Saint John River in particular, the estimated effective number of migrants per generation with the other rivers within the Northeast metapopulation ranged from 2.25-3.43 (King et al. 2014). Overall, we find that the SJRSS may be discrete from other populations based on the existing genetic data.

The petition also asserts that the SJRSS can be considered “discrete,” because it is delimited by the U.S.-Canada border, on either side of which the species experiences significant differences in the control of exploitation, management of habitat, conservation status, and regulatory mechanisms. In support of this assertion, the petition points to the differing conservation status that shortnose sturgeon has under the ESA in the United States and the SARA in Canada. The shortnose sturgeon is listed as “endangered” under the ESA, and the SJRSS is listed as “special concern” under the SARA. Resulting differences include that under the ESA, all “take” of endangered species such as the shortnose sturgeon is prohibited, with take being defined as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct” (16 U.S.C. 1532(19)); whereas, in Canada, under the Fisheries Act, all means of killing SJRSS are prohibited except for fishing (R.S.C.1985,c. F-14), which apparently results in virtually zero mortality due to conservative size restrictions on retention of shortnose sturgeon (COSEWIC 2005). Certain provisions of the ESA apply throughout the range of shortnose sturgeon to prohibit activities undertaken by persons subject to U.S. jurisdiction. See 16 U.S.C. 1538(a)(1)(A), (D)-(F). The petition does not provide additional information to clarify how the differences in the control of exploitation or regulation of the species within the two countries translate into meaningful differences for shortnose sturgeon or its habitat, nor does it explain how the management differences are significant with respect to section 4(a)(1)(D) of the ESA. We find that, while there is insufficient support to use the international boundary as a potential basis for considering the SJRSS “discrete,” the petition does provide sufficient information to indicate that the SJRSS may be discrete based on biological data; and therefore, we proceeded to evaluate information presented in the petition and the cited references with respect to the second criterion of the DPS Policy.

Under the DPS Policy, if a population segment is found to be discrete, then its biological and ecological significance to the taxon to which it belongs is evaluated. This consideration may include, but is not limited to: (1) Persistence of the discrete population segment in an ecological setting unusual or unique for the taxon; (2) evidence that the loss of the discrete population segment would result in a significant gap in the range of a taxon; (3) evidence that the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historical range; and (4) evidence that the discrete population segment differs markedly from other populations of the species in its genetic characteristics (61 FR 4722, February 7, 1996).

The petition states that the SJRSS meets the “significance” criterion of the DPS Policy on the basis of all four of the considerations listed in the policy. First, the petition asserts that the SJRSS persists in a unique ecological setting, because it occurs at the northern extreme of the species' range. Second, the petition states that loss of this population would result in a significant gap in the range of the species, and, third, that the SJRSS is the “only known surviving natural occurrence of this DPS taxon in its historic range.” Lastly, the petition states that the SJRSS differs markedly from other populations of shortnose sturgeon in its genetic characteristics.

We agree that the SJRSS may have markedly different genetic characteristics from other shortnose sturgeon populations, because it has some morphological, behavioral, and genetic differences from other populations. We do not, however, find sufficient information in the petition or cited references to suggest that the riverine, estuarine, or marine habitats of the SJRSS represent a unique ecological setting for the taxon. Supporting information provided in the petition pertained to the life history and habitat use patterns of Atlantic salmon and the Gulf of Maine region; this information is not particularly relevant or explanatory with respect to the uniqueness of SJRSS habitat or shortnose sturgeon. We also find relatively limited support in the petition and references provided to suggest that the loss of this particular population, which occurs at the northernmost portion of the species' range, would result in a significant gap in the species' range. The species is broadly distributed along the East Coast of North America and highly mobile; furthermore, estimated rates of migration are higher among rivers within the northeast region versus the mid-Atlantic region (King et al. 2014). Lastly, we find no support for the assertion that the SJRSS is the only surviving natural occurrence of shortnose sturgeon within its historical range. Shortnose sturgeon are present in at least 42 coastal rivers within the species' historical range (NMFS 2010). We also note that the terms “taxon” and “historical range” in the relevant context of the DPS Policy refer to the larger taxonomic entity, not the DPS under evaluation, as may have been assumed by the Petitioners.

Overall, we conclude that the information presented in the petition and supporting references suggests that the SJRSS may meet the “discreteness” and the “significance” criteria of the DPS Policy and thus may qualify as a DPS. Therefore, we proceeded to review the petition and information readily available in our files to evaluate whether this potential DPS should continue to be protected under the ESA.

The status of the SJRSS was most recently reviewed in 2005 by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC), which is the official scientific body established under SARA responsible for assessing extinction risk of wildlife species in Canada. This most recent assessment concluded that the status of the SJRSS had not changed, and that the population still warranted a status of “special concern (SC),” which is defined under SARA as “a wildlife species that may become a threatened or endangered species because of a combination of biological characteristics and identified threats” (S.C. 2002, c. 29). The 2005 COSEWIC assessment also indicated that the SJRSS met the criterion for “threatened” under SARA based on criterion D2 (i.e., Canadian population with a very restricted index of area of occupancy or number of locations, based on presence in only one river) but was classified as SC because there were “no immediate threats” (COSEWIC 2005). The petition asserts that the SC classification under SARA indicates the SJRSS does not meet the definition of threatened or endangered under the ESA, and that the SC status under SARA is “substantially similar” to the non-regulatory “species of concern” designation that NMFS has extended to some species. NMFS “species of concern” are defined as those species about which we have some concerns regarding status and threats, but for which insufficient information is available to indicate a need to list the species under the ESA (69 FR 19975, April 15, 2004). Under SARA, a threatened species is defined as “a wildlife species that is likely to become an endangered species if nothing is done to reverse the factors leading to its extirpation or extinction” (S.C. 2002, c. 29). A threatened species is defined in section 3 of the ESA as “. . . any species which is likely to become an endangered species within the foreseeable future throughout all or a portion of its range” (16 U.S.C. 1532(3)). While similar, these definitions are not equivalent and require interpretations of different terms. Furthermore, the processes and standards by which species are evaluated under each statute are not the same. Thus, while the “special concern” status under SARA is an indication that the SJRSS is not at immediate risk of extirpation, it remains unclear what status may be warranted for an SJRSS DPS under the ESA.

The 2005 COSEWIC assessment states that incidental bycatch in fisheries, poaching, and habitat loss and degradation are threats to the SJRSS. The petition provides no data or references with which to evaluate the level or trends in bycatch or poaching. Habitat loss and degradation occur in the form of dams, impoundments, and water quality impacts stemming from urban, agricultural and industrial activities (COSEWIC 2005). The petition states that the largest threat to the SJRSS may be the Mactaquac Dam, which was completed in 1967 and is impassable by sturgeon. No studies have been conducted to evaluate the effect of the dam on spawning as a consequence of changes in water flow or temperature (COSEWIC 2005). Aboriginal knowledge also suggests that there has been a decline in the SJRSS since the Mactaquac Dam was constructed (COSEWIC 2005). There have also been no evaluations of the impact of contaminants on shortnose sturgeon in the SJR (COSEWIC 2005). However, water quality in the SJR, while still a significant concern in some areas, has improved since 2000, and many fish communities are healthy and stable (CRI 2011). The majority of the watershed is forested, and all municipalities, which are mostly small, now have sewage treatment capabilities (COSEWIC 2005). Overall, the information provided regarding threats to the SJRSS within its riverine and marine habitats is limited and difficult to fully assess.

The only comprehensive population estimate available for consideration in connection with this finding for the SJRSS population comes from Dadswell's (1979) mark-recapture study in 1973-1977. Dadswell (1979) calculated a Jolly-Seber population estimate of 18,000 (± 30%) adults. Thus, the overall population trend is “unknown” (COSEWIC 2005). However, some evidence suggests the population has remained fairly stable since the 1970's. Size distributions and growth rates for sturgeon sampled in the SJR during 1998-2000 are similar to those measured and estimated for sturgeon sampled in 1973-1977 (COSEWIC 2005). Both time periods indicate a broad range of size and age-classes. A possible indicator of the stability of the SJRSS mentioned in the petition is the stable catch of adult shortnose sturgeon in a 26-year old annual fishing derby on the Kennebecasis River, a tributary of the Saint John. Catch records or some assessment of the catch records from this tournament were not provided in the petition or supporting references, so this statement is difficult to verify at this time. More recent studies conducted in overwintering areas have produced partial adult population estimates of 4,836 ± 69 in 2005 and 3,852-5,222 in 2009 and 2011, indicating persistence at the overwintering sites over this time period and suggesting stable abundance (Li et al. 2007; Usivyatsov et al. 2012). Interestingly, the range of the SJRSS has also recently been scientifically recognized as extending to include the waters off of Nova Scotia: Dadswell et al. (2013) recently confirmed the presence of an adult shortnose sturgeon in the Minas Basin, which is about 165 km from the mouth of the SJR. Fishers also report that they have been catching 1-2 shortnose sturgeon in their weirs during the past decade (Dadswell et al. 2013). Lastly, Stokesbury et al. (2014) used an index called the “Species Ability to Forestall Extinction Index,” or SAFE index, to characterize the SJRSS risk of extinction and concluded that this population was above the authors' particular threshold for “threatened,” which was based on an assumed minimum viable population of 5,000 adults. Because there have been no comprehensive surveys of the SJRSS since the 1970s, Stokesbury et al. (2014) also assumed an adult population size of 18,000 based on the 1973-1977 study by Dadswell (1979) in order to calculate the index for the SJRSS. Overall, while data are lacking with respect to current population abundance and trends, the available evidence suggests that the population has remained stable since the 1970s and is not at high risk of extirpation.

In summary, we find that the shortnose sturgeon within the Saint John River in New Brunswick, Canada, may meet the “discreteness” and “significance” criteria of the DPS Policy (61 FR 4722, February 7, 1996) and thus may qualify as a DPS. We also find that, given the available information regarding the seemingly stable and thus potentially sufficiently high abundance of the shortnose sturgeon in the SJR, the SJRSS, if considered on its own, may not meet the criteria for listing under the ESA. Revisions to the current species-level listing for shortnose sturgeon therefore may be warranted, if we determine it would best further the purposes of the ESA. While there is substantial uncertainty regarding the current population size, trends, and threats, we conclude that the petition and references provide sufficient indication that the petitioned action may be warranted.

After reviewing the information contained in the petition, as well as information readily available in our files, we conclude that the petition presents substantial scientific or commercial information indicating the petitioned actions may be warranted for the SJRSS. We hereby announce the initiation of a status review to determine whether the petitioned population meets the DPS criteria and whether the current species-level listing should be revised.

To ensure that the status review is based on the best available scientific and commercial data, we are soliciting information relevant to the petitioned actions. Specifically, we are soliciting data and information, including unpublished data and information, in the following areas: (1) Recent genetic analyses of populations of shortnose sturgeon; (2) current distribution and abundance of shortnose sturgeon range-wide; (3) movements, migratory patterns and habitat use of shortnose sturgeon along the northeast coast of the United States and in Canadian waters; (4) historical and current population trends for shortnose sturgeon within the Saint John River; (6) past, current and future threats, including bycatch rates and any current or planned activities that may adversely impact the SJRSS; (7) ongoing or planned efforts to protect and restore the SJRSS and their habitat; and (8) management, regulatory, and enforcement information. We request that all information be accompanied by: (1) Supporting documentation such as maps, bibliographic references, or reprints of pertinent publications; and (2) the submitter's name, address, and any association, institution, or business that the person represents.

A complete list of references is available upon request to the Office of Protected Resources (see ADDRESSES).

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).