On February 17, 2012 (77 FR 9515), the NRC published a direct final rule amending its regulations at Title 10 of theCode of Federal Regulations(10 CFR) 72.214, by revising the Holtec International HI-STORM 100 System listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 8 to CoC Number 1014. In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on May 2, 2012. The NRC did not receive any comments on the direct final rule. Therefore, this rule will become effective as scheduled.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in theFederal Registeron January 20, 2012 (77 FR 2930). That NPRM proposed to require removing the affected PT blades from service on or before reaching a new reduced life limit for those certain PT blades.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 2930, January 20, 2012).

Since we issued the proposed AD, we determined that we need to clarify the compliance time. The proposed AD stated 5,000 flight cycles. We changed the AD to state 5,000 flight cycles-since-new.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD with the change described previously.

Based on the service information, we estimate that this AD will affect about 150 engines installed on helicopters of U.S. registry. We also estimate that it will take about 4 work-hours per product to comply with this AD. The average labor rate is $85 per work-hour. A prorated replacement M04 module will cost about $20,000 per engine. Based on these figures, we estimate the cost of the AD on U.S. operators to be $3,051,000.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The Entity List (Supplement No. 4 to Part 744) provides notice to the public that certain exports, reexports, and transfers (in-country) to entities identified on the Entity List require a license from the Bureau of Industry and Security and that the availability of license exceptions in such transactions is limited. Entities are placed on the Entity List on the basis of certain sections of part 744 (Control Policy: End-User and End-Use Based) of the EAR.

The ERC, composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, when appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and all decisions to remove or modify an entry by unanimous vote.

This rule implements the decision of the ERC to add two persons, located in France, to the Entity List on the basis of Section 744.11 (license requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The ERC reviewed Section 744.11(b) (Criteria for revising the Entity List) in making the determination to add the two persons located in France to the Entity List. Under that paragraph, persons for which there is reasonable cause to believe, based on specific and articulable facts, that the persons have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such persons may be added to the Entity List pursuant to Section 744.11. Paragraphs (b)(1)-(b)(5) of Section 744.11 include an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States.

The ERC has reasonable cause to believe that the two persons in France (one company and one individual, an employee of the company) have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that could be contrary to the national security or foreign policy interests of the United States. Specifically, BIS's investigation of the company, Toulouse Air Spares SAS, indicates direct physical and corporate nexus with Aerotechnic France SAS, an Entity List person (76 FR 37632, 6/28/2011). Therefore, pursuant to Section 744.11(b)(5) of the EAR, the ERC determined that the company Toulouse Air Spares SAS and Laurence Mattiucci, the company's president, are engaging in conduct that poses a risk of violating the EAR and that such conduct raises sufficient concern that prior review of exports, reexports or transfers (in-country) of items subject to the EAR involving either of the two persons, and the possible imposition of license conditions or license denials, will enhance BIS's ability to prevent violations of the EAR.

For both of the persons added to the Entity List, the ERC specified a license requirement for all items subject to the EAR and established a license application review policy of a presumption of denial. The license requirement applies to any transaction in which items are to be exported, reexported, or transferred (in-country) to such persons or in which such persons act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to those persons being added to the Entity List.

This final rule adds the following two persons to the Entity List:

(1)Toulouse Air Spares SAS, 8 Rue de la Bruyere, 31120 Pinsaguel, Toulouse, France;and

(2)Laurence Mattiucci, 8 Rue de la Bruyere, 31120 Pinsaguel, Toulouse, France.

This rule also amends the Entity List on the basis of the annual review of theEntity List conducted by the ERC, in accordance with the procedures outlined in Supplement No. 5 to part 744 (Procedures for End-User Review Committee Entity List Decisions). The changes from the annual review of the Entity List that are approved by the ERC are implemented in stages as the ERC completes its review of entities listed under different destinations on the Entity List. This rule implements the results of the annual review for entities listed under Armenia, Germany, Iran, Lebanon, South Korea, Syria, and the U.A.E.

This rule removes two entities from the Entity List, consisting of one entity from Germany and one entity from South Korea, on the basis of the annual review of the Entity List. Specifically, this rule implements the decision of the ERC to remove the following two entities:

(1)Akbar Ashraf Vaghefi,Koburgerstr 10, D-10825, Berlin, Germany.

(1)WASTEC, Inc., a.k.a., With Advanced Systemic Technology,Room 3303, 3304, Na-Dong Chungang Circulation Complex, #1258, Gurobon-Dong, Guro-gu, Seoul, South Korea.

The removal of the above-referenced two entities from the Entity List eliminates the existing license requirements in Supplement No. 4 to part 744 for exports, reexports, and transfers (in-country) to the two entities. However, the removal of these two entities from the Entity List does not relieve persons of other obligations under part 744 of the EAR or under other parts of the EAR. Neither the removal of an entity from the Entity List nor the removal of Entity List-based license requirements relieves persons of their obligations under General Prohibition 5 in section 736.2(b)(5) of the EAR which provides that, “you may not, without a license, knowingly export or reexport any item subject to the EAR to an end-user or end-use that is prohibited by part 744 of the EAR.” Additionally these removals do not relieve persons of their obligation to apply for export, reexport or in-country transfer licenses required by other provisions of the EAR. BIS strongly urges the use of Supplement No. 3 to part 732 of the EAR, “BIS's `Know Your Customer' Guidance and Red Flags,” when persons are involved in transactions that are subject to the EAR.

This rule, pursuant to the ERC's annual review, also removes a third entity from the Entity List, consisting of one entry from the U.A.E. However, this person's name will be added as an alias for another person listed on the Entity List, also under the U.A.E. Therefore, this removal does not remove license requirements for this person. Instead, the addition of the entry as an alias to another listed entity will more clearly identify the relationship between these two persons listed on the Entity List. Specifically, this rule consolidates the entry for “S. Basheer” (i.e.,removes and adds to another entry on the Entity List) as a new alias for the revised “Shaji Muhammed Basheer” entry, as follows:

(1)Shaji Muhammed Basheer,a.k.a., the following alias:

On the basis of decisions made by the ERC during the annual review, in addition to modifying the U.A.E. entry as described above, this rule amends sixteen entries currently on the Entity List, consisting of one entry under Armenia, three entries under Germany, ten entries under Iran, one entry under Lebanon, and one entry under Syria, to provide alternate addresses, alternate spellings for the names of the listed persons, and/or aliases, as follows:

(1)Bold Bridge International, LLC,a.k.a., the following alias:

(1)Djamshid Nezhad,a.k.a., the following alias:

(2)IKCO Trading GmbH,

(3)Nezhad Enterprise Company,a.k.a., the following three aliases:

(1)Atomic Energy Organization of Iran (AEOI),a.k.a., the following two aliases:

(2)Kalaye Electric Company,a.k.a., the following four aliases:

(3)Mahdi Electronics,a.k.a., the following alias:

(4)NBC Navegan Bar Co. Ltd.,a.k.a., the following alias:

(5)Rad Tavan Afza Company,

(6)Raht Aseman Co. Ltd.,

(7)Reza Zahedi Pour,

(8)Shahid Bakeri Industrial Group,a.k.a., the following nine aliases:

(9)Shahid Hemmat Industrial Group,a.k.a., the following six aliases:

(10) Simin Neda Industrial and Electrical Parts, a.k.a., the following alias:

(1)EKT Electronics,a.k.a. the following four aliases:

(1)EKT Electronics,a.k.a., the following four aliases:

Finally, on the basis of decisions made by the ERC during the annual review, this rule adds four persons to the Entity List, consisting of one person in Canada, one person in Egypt, one person in France, and one person in the U.K. The decision to add these four persons was made during the annual review and is based on Section 744.11 of the EAR. Similar to the process outlined above for the other Section 744.11 additions described in this rule, the ERC as part of the annual review process reviewed Section 744.11(b) in making the determination to add these four persons.

These four persons are believed to have been involved in activities described under paragraphs (b)(1) and (b)(2) of Section 744.11. Specifically, the two persons located in Canada and Egypt are being added because of their affiliation with EKT Electronics, a person currently listed on the Entity List under Lebanon and Syria. BIS first included EKT Electronics as a listed person under General Order No. 3, which was first published on June 5, 2006, and subsequently amended on September 6, 2006. General Order No. 3 listed persons concerning whom the U.S. Government possessed information regarding the acquisition or attempted acquisition of electronic components and devices capable of being used in improvised explosive devices (IEDs) used against Coalition Forces in Iraq and Afghanistan. These two persons being added are not aliases of EKT Electronics, but are believed to be affiliated and involved in the same types of activities of concern under paragraphs (b)(1) and (b)(2) of Section 744.11 and therefore also warrant being added to the Entity List.

Similarly, the two persons located in France and the U.K. are being added to the Entity List as a result of their affiliation with IKCO Trading GmbH (IKCO), a person currently on the Entity List under Germany. The French and the U.K. persons are involved in the same types of Section 744.11 activities that resulted in IKCO being added to the Entity List on September 22, 2008 (73 FR 54507). BIS first included IKCO as a listed person under General Order No. 3, which was first published on June 5, 2006, and subsequently amended on September 6, 2006. As noted above, General Order No. 3 listed persons concerning whom the U.S. Government possessed information regarding the acquisition or attempted acquisition of electronic components and devices capable of being used in IEDs used against Coalition Forces in Iraq and Afghanistan. These two persons being added are not aliases of IKCO, but are believed to be affiliated and involved in the same types of activities of concern under paragraphs (b)(1) and (b)(2) of Section 744.11 and therefore also warrant being added to the Entity List.

For the four persons added to the Entity List on the basis of the annual review, the ERC specified a license requirement for all items subject to the EAR and established a license application review policy of a presumption of denial. The license requirement applies to any transaction in which items are to be exported, reexported, or transferred (in-country) to such persons or in which such persons act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to those persons being added to the Entity List.

This final rule adds the following four persons to the Entity List:

(1)EKT 2, Inc.,

(1)AL-AMIR ELECTRONICS,

(1)IKCO France,

(1)IKCO Finance,

Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export or reexport, on April 25, 2012, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR).

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as extended by the Notice of August 12, 2011, 76 FR 50661 (August 16, 2011), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by the OMB under control numbers 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email toJasmeet_K._Seehra@omb.eop.gov, or by fax to (202) 395-7285.

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (See5 U.S.C. 553(a)(1)). BIS implements this rule to protect U.S. national security or foreign policy interests by preventing items from being exported, reexported, or transferred (in country) to the persons being added to the Entity List. If this rule were delayed to allow for notice and comment and a delay in effective date, then entities being added to the Entity List by this action would continue to be able to receive items without a license and to conduct activities contrary to the national security or foreign policy interests of the United States. In addition, because these parties may receive notice of the U.S. Government's intention to place these entities on the Entity List once a final rule was published, it would create an incentive for these persons to either accelerate receiving items subject to the EAR to conduct activities that are contrary to the national security or foreign policy interests of the United States, and/or to take steps to set up additional aliases, change addresses, and other measures to try to limit the impact of the listing on the Entity List once a final rule was published. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601et seq.,are not applicable.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

This document contains amendments to 26 CFR part 31 under section 3402(t) of the Internal Revenue Code (Code), relating to three percent withholding by government entities on payments for property or services. Section 3402(t) of the Code was added by section 511 of the Tax Increase Prevention and Reconciliation Act of 2005, Public Law 109-222 (TIPRA), 120 Stat. 345, which was enacted on May 17, 2006. The Treasury Department and the IRS issued final regulations under sections 3402(t), 3406, 6011, 6051, 6071, and 6302 of the Code that were published in theFederal Registeron May 9, 2011 (TD 9524, 76 FR 26583, 2011-23 IRB 843) (the May 2011 final regulations). Those regulations were issued to implement the requirements of section 3402(t) and conform existing regulations to section 3402(t).

Section 102 of the 3% Withholding Repeal and Job Creation Act (Pub. L. 112-56, 125 Stat. 711), which was enacted on November 21, 2011, repealed section 3402(t) of the Code. Section 3402(t) was repealed before it became effective.

This document, therefore, removes the regulatory provisions issued under section 3402(t) and related sections, and makes conforming amendments to certain regulations to reflect the removal of the section 3402(t) regulations.

At the same time as the issuance of the May 2011 final regulations, the Treasury Department and the IRS also issued proposed regulations under section 3402(t), published in theFederal Registeron May 9, 2011 (REG-151687-10, 76 FR 26678, 2011-23 IRB 867). A related document withdraws those proposed regulations in light of the repeal of section 3402(t). See REG-151687-10.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to this regulation, and because no notice of proposed rule making is required for this rule, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply.

The principal author of these final regulations is A. G. Kelley, Office of the Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 31 is amended as follows:

Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS ASHLAND (LSD 48) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS withoutinterfering with its special function as a naval ship: Annex I, paragraph 3(a), pertaining to the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 2(k) as described in Rule 30 (a)(i), pertaining to the vertical separation between anchor lights. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

For the reasons set forth in the preamble, amend part 706 of title 32 of the CFR as follows:

You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. Potentially affected entities may include, but are not limited to:

• Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed underFOR FURTHER INFORMATION CONTACT.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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, acopy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2.Tips for preparing your comments.When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading,Federal Registerdate and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in theFederal Registerissue of April 24, 1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in theFederal Registerits reasons for not taking action.

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 23 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

EPA is establishing significant new use and recordkeeping requirements for 23 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).

• Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA section 5(e) consent orders).

• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture and importation volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

This rule includes nine PMN substances (P-07-537, P-07-706, P-10-135, P-10-358, P-11-264, P-11-561, P-11-567, P-11-568, and P-11-569) that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protectivemeasures required in the corresponding consent orders.

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance.

This rule also includes SNURs on 14 PMN substances (P-05-714, P-11-128, P-11-338, P-11-481, P-11-594, P-11-654, P-12-22, P-12-23, P-12-24, P-12-25, P-12-26, P-12-33, P-12-51, and P-12-52) that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures or releases, thereby constituting a “significant new use.” These so-called “non-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

Chemical name:Polyether ester acid compound with a polyamine amide (generic).

CAS number:Not available.

Basis for action:The PMN states that the substance will be used as an additive for industrial paints, industrial coatings, and architectural coatings. Based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than described in the PMN, exceed the releases expected from the use described in the PMN. For the use described in the PMN, significant environmental releases are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i).

Recommended testing:EPA has determined that the results of a fish acute toxicity mitigated by humic acid test (Office of Pollution Prevention, Pesticides and Toxic Substances (OPPTS) Test Guideline 850.1085) would help characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10410.

Chemical name:Alkanenitrile, bis(cyanoalkyl)amino (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:June 19, 2009.

Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the PMN substance will be as a chemical intermediate. Based on test data on the PMN substance, EPA identified concerns for neurotoxicity to workers from dermal and inhalation exposures. The NCEL is 70 microgram/cubic meter (μg/m3) as an 8-hour time-weighted average. In addition, based on ecological structure-activity relationship (EcoSAR) analysis of test data on structurally similar aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 700 parts per billion (ppb). The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires:

1. Use of personal protective equipment including impervious gloves (when there is potential dermal exposure) and either a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 5, or compliance with a NCEL of 70 μg/m3as an 8-hour time-weighted average (when there is potential inhalation exposure).

2. Establishment and use of a hazard communication program.

3. Manufacture and use of the PMN substance only as a site-limited intermediate.

4. Submission of certain human health testing prior to exceeding the confidential production volume limit specified in the consent order.

5. Disposal of the PMN substance only by incineration or landfill.

6. No release of the PMN substance into the waters of the United States.

Recommended testing:EPA has determined that the results of a neurotoxicity study in rodents (Organisation for Economic Co-operation and Development (OECD) Test Guideline 424); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1085); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance. The PMN submitter has agreed not to exceed the confidential production volume limit specified in the consent order without performing the neurotoxicity test. The consent order does not require the submission of the fish and daphnid testing at any specified time or production volume. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10411.

Chemical name:Phosphonic acid ester (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:April 8, 2009.

Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on the PMN substance and an analogous chemical, EPA identified concerns for oncogenicity, mutagenicity, reproductive/developmental toxicity, skin irritation, and sensitization to workers from dermal and inhalation exposures. The NCEL is 1.0 milligram (mg)/m3as an 8-hour time-weighted average. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires:

1. Use of personal protective equipment including dermal protection (when there is potential dermal exposure) and a NIOSH-certified respirator with an assigned protection factor (APF) of at least 15, or compliance with a NCEL of 1.0 mg/m3as an 8-hour time-weighted average (when there is potential inhalation exposure).

2. Establishment and use of a hazard communication program.

3. Submission of certain human health testing prior to exceeding the confidential production volume limit specified in the consent order.

Recommended testing:EPA has determined that the results of a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OECD Test Guideline 422) and a mammalian erythrocyte micronucleus test (OECD Test Guideline 474) would help characterize possible human health risks of the PMN substance. The PMN submitter has agreed not to exceed the confidential production volume limit specified in the consent order without performing these tests. The consent order does not require the submission of a genetic toxicology: rodent dominant lethal assay test (OECD Test Guideline 478) at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10412.

Chemical name:Fluorinated dialkyl ketone (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:October 21, 2011.

Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the substance will be as a heat transfer fluid. Based on test data on the PMN substance and analogs, EPA identified concerns for oncogenicity and liver effects from dermal and inhalation exposures. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order prohibits exceedance of the confidential annual production volume limit specified in the consent order. The SNUR designates as a “significant new use” the absence of this protective measure.

Recommended testing:EPA has determined that a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) and a reproduction/developmental toxicity screening test (OECD Test Guideline 421, with modifications) would help characterize the human health effects of the PMN substance. The consent order does not require the submission of this testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10413.

Chemical name:Iron(1+), chloro[rel-1,5-dimethyl (1R,2S,4R,5S)- 9,9-dihydroxy-3-methyl-2,4-di(2-pyridinyl-.kappa.N)-7-[(2-pyridinyl-.kappa.N)methyl]-3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylate-.kappa.N3,.kappa.N7]-, chloride (1:1), (OC-6-63)-.

CAS number:478945-46-9.

Effective date of TSCA section 5(e) consent order:February 7, 2011.

Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the substance will be as a coatings additive at concentrations not to exceed 1.0 percent. Based on test data on the PMN substance, EPA identified concerns for systemic toxicity, neurotoxicity, dermal sensitization, acute toxicity and immunotoxicity from dermal exposure. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires:

1. Use of personal protective equipment including dermal protection (when there is potential dermal exposure).

2. Establishment and use of a hazard communication program.

3. Use of the PMN substance only as described in the PMN.

4. That annual manufacture and importation volume not exceed the confidential limit specified in the consent order.

5. No manufacture, processing, or use of the PMN substance in the form of a powder or a solid.

Recommended testing:EPA has determined that the results of an acute oral toxicity test (OPPTS Test Guideline 870.1100) in rabbits would help characterize the human health effects of the substance. The consent order does not require submission of the testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMNs will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10414.

Chemical name:3H-indolium, 2-[2-[3-[2-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)ethylidene]-2-[(1-phenyl-1H-tetrazol-5-yl)thio]-1-cyclohexen-1-yl]ethenyl]-1,3, 3-trimethyl-, chloride (1:1).

CAS number:440102-72-7.

Basis for action:The PMN states that the substance will be used as a dye used in the manufacture of imaging media/products. Based on EcoSAR analysis of test data on cationic dyes, EPA predicts toxicity to aquatic organisms may occur as a result of releases of the PMN substance to surface water from manufacture or import in quantities greater than the 10,000 kilograms (kg) per year production volume stated in the PMN. At the annual production volume of 10,000 kg stated in the PMN,there were no significant environmental concerns. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that exceeding an annual manufacturing and importation volume of 10,000 kg may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10415.

Chemical name:Brominated polyphenyl ether (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:November 22, 2011.

Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the PMN substance will be as a flame retardant. EPA expects that brominated dibenzodioxins (BDD) and dibenzofurans (BDF) may be generated during manufacture of the PMN substance and may be potential decomposition products of the PMN substance in the environment. Human health concerns from exposure to BDD and BDF include cancer, reproductive and developmental toxicity, and immunotoxicity. EPA expects the PMN to be highly persistent in the environment and that it may be bioavailable based on data on related substances. EPA also has environmental concerns based on the high degree of bromination of the PMN substance and the potential presence of BDD/BDF impurities that may form during manufacturing and may be decomposition products in the environment. Current knowledge of the ecotoxicity of BDD and BDF indicate adverse effects may occur in the parts per trillion range in rainbow trout embryos and juveniles. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance and potential impurities and degradants may present an unreasonable risk of injury to human health and the environment, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance. To protect against these risks the consent order requires:

1. No exceedance of the maximum levels of BDD and BDF in the PMN substance as specified in the consent order.

2. Manufacture of the PMN substance only at the site specified in the PMN and only using the process described in the PMN unless the dioxin/furan testing required in the consent order is conducted and the test results submitted to EPA within 16 months of commencement of manufacture at the additional site or process.

3. The molecular weight of the manufactured PMN substance be equal to or greater than the weight reported in the PMN.

Recommended testing:EPA has determined that the results of the following tests would help characterize the possible health and environmental effects of the PMN substance, its impurities and its degradation products. The consent order contains two (confidential) production limits. The PMN submitter has agreed not to exceed the first production limit without performing an anaerobic aquatic metabolism test (OPPTS Test Guideline 835.4400) and an amphibian metamorphosis assay (OECD Test Guideline 231). The PMN submitter has also agreed not to exceed a second production limit without performing a dietary exposure bioaccumulation fish test (OECD Test Guideline 305, draft dated October 14, 2011) and a test of the PMN substance for BDD and BDF content by high-resolution gas chromatography/high-resolution mass spectrometry (HRGC/HRMS) (EPA Test Method 8290A). EPA has also determined that the following tests would help characterize the environmental effects of the PMN substance. The consent order does not require the submission of the following information at any specified time or production volume: A fish early-life stage toxicity test (OPPTS Test Guideline 850.1400), a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and an algal toxicity, tiers I and II test (OPPTS Test Guideline 850.5400). However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10416.

Chemical name:Biphenyl alkyl morpholino ketone (generic).

CAS number:Not available.

Basis for action:The PMN states that the substance will be used as a photo initiator. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 2 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II test (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. EPA also recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility.

CFR citation:40 CFR 721.10417.

Chemical name:1,2-Cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester.

CAS number:1200806-67-2.

Basis for action:The PMN states that the generic (non-confidential) use of the substance is as an additive for polymers. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 2 ppb. Therefore, EPA has not determined that the proposedmanufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 2 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10418.

Chemical name:Tetrafluoroethylene chlorotrifluoroethylene copolymer (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:January 27, 2012.

Basis for TSCA section 5(e) consent order:The PMN states that the substance will be used as a polymer used in automotive fuel hoses. Based on EPA analysis of the potential content of the polymer, EPA is concerned that some long-chain perfluorinated substances could be present and if degraded, especially under thermal conditions, could be released into the environment. EPA has concerns that the PMN substance and its thermal degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to humans, wild mammals, and birds. These concerns are based on data on analog chemicals, including perfluorooctanoic acid (PFOA) and other perfluorinated carboxylates, which include the presumed environmental degradant of the PMN substance. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species, as well as cancer. These factors, taken together, raise concerns for potential adverse chronic effects from the presumed degradation product in humans and wildlife. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance may present an unreasonable risk of injury to human health and the environment, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against this exposure and risk, the consent order requires the PMN substance be manufactured, processed, distributed in commerce, and used only as a polymer in automotive fuel hoses and the submitter has agreed to analyze, report, and limit specific fluorinated impurities of the PMN substance where the carbon chain meets or exceeds a specified length. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing:EPA has determined that the results of certain fate and physical/chemical property testing identified in the consent order would help characterize possible effects of the substances and their degradation products. The consent order does not require submission of the testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10419.

Chemical name:Fluoropolymers (generic).

CAS number:Not available.

Effective date of TSCA section 5(e) consent order:January 27, 2012.

Basis for TSCA section 5(e) consent order:The PMNs state that the generic (non-confidential) use of the PMN substances will be in the manufacture of elastomer containing materials (P-11-567 and P-11-569), and a component of film, wire, and cable (P-11-568). Based on SAR analysis of test data on analogous high molecular weight polymers, EPA identified concerns for lung effects through lung overload if respirable particles of the intact PMN substances are inhaled. In addition, EPA has concerns for the formation of potential incineration or other decomposition products from the PMN substances. These perfluorinated products may be released to the environment from incomplete incineration of the PMN substances at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers, suggesting that, under some conditions, the PMN substance could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to people, wild mammals, and birds. These concerns are based on data on analog chemicals, including PFOA and other perfluorinated carboxylates, which include the presumed environmental degradant of the PMN substance. There is pharmacokinetic and toxicological data in animals on PFOA, as well as epidemiological and blood monitoring data in humans. Toxicity studies on PFOA indicate developmental, reproductive, and systemic toxicity in various species, as well as cancer. These factors, taken together, raise concerns for potential adverse chronic effects from the presumed degradation product in humans and wildlife. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance may present an unreasonable risk of injury to human health and the environment, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against these risks, the consent order requires the submitter has agreed to analyze, report, and limit specific fluorinated impurities of the PMN substances where the carbon chain meets or exceeds a specified length and risk notification. The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing:EPA has determined that the results of certain fate and physical/chemical property testing identified in the consent order would help characterize possible effects of the substances and their degradation products. The consent order does not require submission of the testing at any specified time or production volume. However, the consent order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMNs will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation:40 CFR 721.10420.

Chemical name:Mercaptoalkoxysilane (generic).

CAS number:Not available.

Basis for action:The PMN states that the substance will be used as an epoxy catalyst. Based on EcoSAR analysis of test data on analogous alkoxysilanes, esters, and phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be released to water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 2 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at§ 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10421.

Chemical name:Phenol, 2-[[[3-(1H-imidazol-1-yl)propyl]imino]phenylmethyl]-5-(octyloxy)-.

CAS number:1332716-20-7.

Basis for action:The PMN states that the substance will be used as an epoxy catalyst. Based on EcoSAR analysis of test data on analogous Schiff bases and phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be released to water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at§ 721.170(b)(4)(ii).

Recommended testing:EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.

CFR citation:40 CFR 721.10422.

Chemical names:Complex strontium aluminum, rare earth doped (generic).

CAS numbers:Not available.

Basis for action:The PMNs state that the PMN substances will be used as dye used in the manufacture of imaging media/products. Based on analogous respirable and poorly soluble substances, in particular, titanium dioxide, EPA identified concerns for potential lung overload to workers from inhalation exposure to the PMN substances. Specifically, the Agency predicts potential toxicity to workers from inhalation when more than 5% of the PMN substances particles are less than 10 microns. For the uses described in the PMNs, significant worker exposure is unlikely, when no more than 5% of particles are less than 10 microns. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as described in the PMNs may cause serious health effects. Based on this information, the PMN substances meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing:EPA has determined that a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substances.

CFR citation:40 CFR 721.10423.

Chemical name:Benzoic acid, 4-(1,1-dimethylethyl)-, methyl.

CAS number:26537-19-9.

Basis for action:The PMN states that the substance will be used as an intermediate in the manufacture of an imaging product. Based on submitted test data on p-tert-butyl benzoic acid, EPA identified concerns for neurotoxicity; reproductive toxicity (male); and adverse effects to the liver, kidney, and lung. In addition, based on data on benzoic acid, EPA identified concerns for developmental toxicity and hypersensitivity. These concerns are for effects to workers from inhalation and dermal exposures to the PMN substance. For the chemical intermediate use described in the PMN, significant worker exposure is unlikely, as dermal and inhalation exposures are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, use of the substance other than as an intermediate may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing:EPA has determined that a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OPPTS Test Guideline 870.3650) would help characterize the human health effects of the PMN substance.

CFR citation:40 CFR 721.10424.

Chemical names:Substituted alkylamides (generic).

CAS numbers:Not available.

Basis for action:The PMNs state that the generic (non-confidential) use of the substances will be as polymer foam additives. Based on test data on analogous chemical substances and information on the Material Safety Data Sheet (MSDS), the Agency identified concerns for irritation to all exposed tissues, solvent irritation, and solvent neurotoxicity to workers from dermal exposure to the PMN substances. For the use described in the PMNs, significant worker exposure is unlikely, as dermal exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, use of the substances other than as described in the PMNs may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).

Recommended testing:EPA has determined that the results of a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OPPTS Test Guideline 870.3650); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); and a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) would help characterize the human health effects of the PMN substances.

CFR citation:40 CFR 721.10425.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 9 of the 23 chemical substances, regulation was warranted under TSCA section 5(e), pending the developmentof information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit II.).

In the other 14 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.

• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.

• EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.

• EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet athttp://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is June 25, 2012 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before May 25, 2012.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before May 25, 2012, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule April 25, 2012.

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 9 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 19 of the 23 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMNbona fidesubmissions (per 40 CFR 720.25 and § 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

As discussed in the April 24, 1990 SNUR, EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements because a person could defeat the SNUR by initiating the significant new use before the rule became effective, and then argue that the use was ongoing before the effective date of the rule. Persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including any extensions expires.

EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is considered exempt from the requirements of the SNUR.

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. describes those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests areprovided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection and test reporting. To access the harmonized test guidelines referenced in this document electronically, please go tohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop athttp://www.oecdbookshop.orgor SourceOECD athttp://www.sourceoecd.org.To access EPA Method 8290A, please go tohttp://www.epa.gov/osw/hazard/testmethods/sw846/pdfs/8290a.pdf.

In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture, import, or processing.

The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Potential benefits of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at § 721.1725(b)(1).

Under these procedures a manufacturer, importer, or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has abona fideintent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown abona fideintent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use identified in thebona fidesubmission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers, importers, and processors can combine thebona fidesubmission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.

If EPA determines that the use identified in thebona fidesubmission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in thebona fidesubmission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a newbona fidesubmission would be necessary to determine whether that higher volume would be a significant new use.

According to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in § 721.25 and 40 CFR 720.40. e-PMN software is available electronically athttp://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2012-0182.

This rule establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq.,an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in theFederal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of thetable, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

On February 18, 2012, EPA certified pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

2. The SNUN submitted by any small entity would not cost significantly more than $8300.

A copy of that certification is available in the docket for this rule.

This rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

• Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this rule. As such, EPA has determined that this rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action will not have a substantial direct effect on 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, entitled “Federalism” (64 FR 43255, August 10, 1999).

This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination With Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this rule.

This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 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, entitled “Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Pursuant to the Congressional Review Act, 5 U.S.C. 801et seq.,EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR parts 9 and 721 are amended as follows:

This preamble is organized as follows:

HHS received comments from six individuals and organizations on the notice of proposed rulemaking published in theFederal Registeron July 1, 2011 (76 FR 38938). One anonymous commenter expressed anger about the WTC Health Program's cost to American taxpayers; another individual asked that leukemia and other blood cancers be added to the list of WTC-related health conditions; and a physician experienced with treating WTC-related health conditions requested that a mental disorder be added to the list of WTC-related health conditions. Those comments are outside the scope of this rulemaking and could not be considered. HHS received substantive comments from the New York State Laborers' Health & Safety Trust Fund, the Communication Workers of America, and the WTC Health Program Survivor Steering Committee. Those comments are described and addressed below.

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) to add Title XXXIII1 establishing the WTC Health Program within HHS. HHS issued an interim final rule on July 1, 2011 (76 FR 38914), which codified the Program in 42 CFR Part 88. Sections 88.1 through 88.16 were included in that rulemaking; this final rule establishing § 88.17 was developed in a separate rulemaking.

The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers (including those who are Federal employees) who responded to the September 11, 2001, terrorist attacks, and to eligible survivors of the New York City attacks. The WTC Health Program will expand to include eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks at the Pentagon and Shanksville, PA. The WTC Program Administrator has gathered information that may serve as a basis for such enrollment, and is working to develop eligibility criteria for these responder groups.

All references to the WTC Program Administrator in this notice mean the NIOSH Director or his or her designee.

Title XXXIII of the PHS Act authorizes the WTC Program Administrator to establish a process by which health conditions, including cancer, may be considered for addition to the list of WTC-related health conditions. This final rule establishes this process.

The list of WTC-related health conditions defined in sections 3312 and 3322 of Title XXXIII of the PHS Act may be amended in the future to add other conditions for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or condition (Title XXXIII, Sec. 3312(a)(1)(A)(i)).

Procedures for the addition of a new condition are established in this final rule. The addition of a new conditioncould be initiated either by petition from an interested party or at the discretion of the WTC Program Administrator, as specified in this final rule.

This amendment to Part 88 would add the definition of “interested party” to the list of definitions established by interim final rule on July 1, 2011 (76 FR 38914).

Comment:HHS received two comments requesting that the definition of “interested party” be expanded to reference survivor organizations.

HHS response:The definition of “interested party” was taken directly from Title I of the James Zadroga 9/11 Health and Compensation Act of 2010. Although the statutory definition of “interested party” does not explicitly mention “survivor organizations,” HHS believes that the definition includes “survivor organizations.” HHS does not agree that amending the rule text is necessary and is therefore not amending the definition.

In accordance with the requirements specified in Title XXXIII of the PHS Act, § 88.17 establishes the process by which an interested party could petition the WTC Program Administrator to add a condition to the list of WTC-related health conditions identified in § 88.1. Under the provisions of § 88.17(a)(1), the petition must include the name and contact information of the interested party; the name and description of the condition the party would like the WTC Program Administrator to add to the list of WTC-related health conditions; and an explanation of the reasons for adding the condition, which must include the medical basis for the association between the September 11, 2001, terrorist attacks and the condition to be added.

HHS has received some communications for which it is unclear whether the author intends to petition for the addition of a health condition or whether the author is expressing personal concerns. Since a petition results in Federal action, as specified under this rule, it is important that the intent to petition be unambiguous. Accordingly, HHS has amended the final rule text to clarify that the petition must state the petitioner's intent to petition for the addition of a health condition.

The provisions of § 88.17(a)(2) incorporate specifications in Title XXXIII of the PHS Act regarding the addition of new conditions. Within 60 days of receipt of the petition, the WTC Program Administrator will either: request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC); open the proposed condition to public comment by publishing a notice of proposed rulemaking (NPRM) in theFederal Register; publish the WTC Program Administrator's determination not to publish an NPRM; or publish in theFederal Registera determination that not enough evidence exists to perform any of the above actions. HHS has amended the final rule text to acknowledge that a petition may request the addition of more than one health condition.

HHS has also inserted § 88.17(a)(4) into the final rule to clarify that the Administrator shall be required to reconsider a previously-considered (but not added) health condition for inclusion on the list of WTC-related health conditions in response to a petition only when the petition includes a new medical basis for the association between the terrorist attacks and the condition. A new medical basis could include a health study, whether original or updated, not previously considered by the WTC Program Administrator. A new clinical case report on a particular health condition which compiles data from one or more patients may not necessarily be considered a new medical basis if the Administrator has previously considered one or more cases of the health condition. The Administrator retains the discretion, however, to reconsider a health condition for any reason on his own initiative, with or without the receipt of a petition.

Comment:One commenter requested that all submitted petitions be shared with the STAC regardless of whether the WTC Program Administrator seeks a formal recommendation from the Committee.

HHS response:HHS appreciates this suggestion and agrees that, in the interest of keeping the STAC informed of relevant public interest, petitions received by the WTC Program Administrator will be shared with the Committee and with the public via the Program's Web site. HHS does not believe that amending the rule text is warranted.

Comment:A commenter also asked that a mechanism be developed to allow at least two members of the STAC to request to consider a petition and make a recommendation in the event that the WTC Program Administrator has determined not to publish an NPRM or where the Administrator determines that insufficient evidence exists to take action on a petition.

HHS response:According to the requirements of Title XXXIII of the PHS Act, the Committee's role is to review evidence and make recommendations to the WTC Program Administrator at the request of the Administrator, not to provide unsolicited reviews. Any work conducted by the STAC must be consistent with the purposes for which the Committee may be utilized as identified by the statute and the Committee charter. Therefore, this comment is not adopted.

Subsection (b) also incorporates the statutory requirement that the WTC Program Administrator may publish an NPRM concerning the addition of a WTC-related health condition to the list. The Administrator would consider publishing an NPRM where the review of cancers required by Sec. 3312(a)(5)(A) of Title XXXIII of the PHS Act indicates that a type of cancer should be added, or where the review of WTC Health Program monitoring data reveals the prevalence of a condition not previously identified by the statute or Program. The protocol for such a review will take into account an evaluation of the exposure data associated with the terrorist attacks, and an evaluation of available epidemiologic, toxicologic, and medical evidence relevant to evaluating the possible association between the health condition under consideration and exposures associated with the September 11, 2001, terrorist attacks. How these various relevant sources of scientific and medical information will be evaluated, separately and in relation to each other, will depend on the evidence available for a given health condition under consideration. HHS notes that scientists generally look for consistency in terms of disease-mechanism theories, toxicologic and epidemiologic findings, and medical observation. The addition of any health condition requires rulemaking, and the public will have the opportunity to consider and comment on the review methods applied in any actual case.

The WTC Program Administrator may extend the comment period described above based upon a finding of good cause. In the case of such an extension, the Administrator shall publish notice in theFederal Register.

Comment:HHS received several comments concerning deadlines not specified in the regulatory text. One commenter suggested that HHS did not include every deadline related to the addition of a WTC-related healthcondition provided by the statute. Two comments asked that we specify a time frame for the publication of an NPRM or aFederal Registernotice indicating that the WTC Program Administrator has determined not to publish an NPRM; one asked that we specify the publication of an NPRM 30 days following a STAC recommendation. Comments also requested that we specify a time frame for publication of a final rule; one asked that we require publication within 60 days after the close of an NPRM comment period.

HHS response:Each deadline specified by the PHS Act with regard to this matter has been incorporated into the regulatory text. We have specified a time frame for the publication of an NPRM following a STAC recommendation in Sec. 88.17(b)(2) according to the time frame specified in the statute. We agree with commenters who pointed out that we neglected to specify a time frame for publication of aFederal Registernotice indicating a decision not to publish an NPRM following receipt of a STAC recommendation, and have amended the rule text accordingly. However, Congress did not specify a time frame for publication of a final rule. HHS is concerned that establishing such requirements by regulation could negatively impact the thorough review of scientific evidence supporting or opposing the inclusion of a specific health condition. Because of the need to ensure that a thorough review has been conducted in all cases, HHS is not making changes to the rule based on these comments. Every effort will be made to promptly review public comments and STAC recommendations, and that publication of a final rule will occur in as efficient and timely a manner as is possible.

Comment:One commenter requested that HHS develop procedures for the WTC Program Administrator to notify an individual when a new condition is added, if the individual was previously denied coverage for that condition.

HHS response:Information about newly-added WTC-related health conditions will be provided on the WTC Health Program Web site and shared with all Program physicians. Program physicians would be best placed to advise individuals on whether applying for certification of a newly-designated WTC-related health condition is appropriate. The WTC Health Program will consider this request further to identify other ways in which Program participants may be notified of a new WTC-related health condition.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives of significant regulatory actions and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This final rule is considered a “significant regulatory action” within the meaning of E.O. 12866. The rule establishes processes by which the WTC Program Administrator may consider the addition of health conditions to the current statutory list of WTC-related health conditions covered by this program. This strictly procedural rule does not itself propose the addition of any conditions and hence it does not provide for any benefits nor impose any costs, other than the minor incidental administrative costs to HHS of considering possible additions. Under any circumstance, HHS would be required to conduct rulemaking to make an addition, as required by Title XXXIII of the PHS Act. Accordingly, any quantifiable costs and benefits associated with adding a condition would be addressed in such future rulemaking.

This rule does not adversely affect in a material way the economy, a sector of the economy, productivity, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; it does not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; it does not materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; nor does it raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601et seq., requires each agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-for-profit organizations. HHS believes that this rule has “no significant economic impact upon a substantial number of small entities” within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601et seq.).

This regulation has no impact on small businesses or other small entities as specified under the RFA. The rule establishes procedures by which the WTC Health Program Administrator may consider the addition of health conditions to the current statutory list of WTC-related health conditions covered by this program. These procedures do not impose any requirements or direct costs on small entities. They do not involve small entities, except that a small entity could potentially be considered an “interested party” under these procedures, eligible to petition the WTC Program Administrator for the addition of a health condition.

The Secretary of HHS has certified to the Chief Counsel, Office of Advocacy of the Small Business Administration, that this rule does not have a significant impact on a substantial number of small entities. Accordingly, no regulatory impact analysis is required.

HHS has determined that this final rule contains data collection and record keeping requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1955 (44 U.S.C. 3501-3420). A description of these provisions is given below with an estimate of the annual reporting burden. Included in the estimate of the annual reporting burden is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. These data collection and record keeping requirements have been approved under OMB control number 0920-0929, exp. April 30, 2015.

Project:Adding a Health Condition to the Statutory List of WTC-Related Health Conditions (42 CFR 88.17)—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description:Title I of the James Zadroga Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and HumanServices (HHS). This final rule establishes the processes by which the WTC Program Administrator may add a new condition to the list of WTC-related health conditions through rulemaking, including a process for considering petitions by interested parties to add a new condition; the process will be codified at 42 CFR 88.17.

Section 88.17, entitled “Addition of Health Conditions to the List of WTC-Related Health Conditions,” describes the process and data collection requirements that an interested party should follow to petition the WTC Program Administrator to add a condition to the list of WTC-related health conditions. HHS expects to receive no more than 100 petitions annually. We assume that interested parties will be enrolled WTC responders, screening-eligible survivors, certified-eligible survivors, or members of groups who advocate on behalf of responders or survivors. We estimate that an individual will spend an average of 40 hours gathering information to substantiate a request to add a health condition and assembling the petition. HHS requests input from the public on these estimates, which are reflected in the table below. The total burden on the public is estimated to be 4,000 hours.

As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will report the promulgation of this rule to Congress prior to its effective date.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531et seq.) directs agencies to assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this final rule does not include any Federal mandate that may result in increased annual expenditures in excess of $100 million by State, local or Tribal governments in the aggregate, or by the private sector. For 2011, the inflation adjusted threshold is $136 million.

This final rule has been drafted and reviewed in accordance with Executive Order 12988, “Civil Justice Reform,” and will not unduly burden the Federal court system. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.

HHS has reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” The rule 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.”

In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this rule on children. HHS has determined that the rule would have no environmental health and safety effect on children.

In accordance with Executive Order 13211, HHS has evaluated the effects of this final rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect.

Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS has attempted to use plain language in promulgating the final rule consistent with the Federal Plain Writing Act guidelines.

For the reasons discussed in the preamble, the Department of Health and Human Services amends 42 CFR part 88 as follows:

This document announces that, on April 16, 2012, OMB approved, for a period of three years, the information collection requirements contained in the Commission'sReport and Order,FCC 11-151, published at 76 FR 82354, December 30, 2011. The OMB Control Number is 3060-1167. The Commission publishes this notice as an announcement of the effective date of the rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-1167, in your correspondence. The Commission will also accept your comments via the Internet if you send them toPRA@fcc.gov <mailto:PRA@fcc.gov>.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email tofcc504@fcc.gov <mailto:fcc504@fcc.gov>or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on April 16, 2012, for the information collection requirements contained in the Commission's rules at 47 CFR 14.5, 14.20(d), 14.31, 14.32, and 14.34 through 14.52.

Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1167.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Pub. L. 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number:3060-1167.

OMB Approval Date:April 16, 2012.

OMB Expiration Date:April 30, 2015.

Title:Accessible Telecommunications and Advanced Communications Services and Equipment.

Form Number:N/A.

Type of Review:New collection.

Respondents:Individuals or households; businesses or other for-profit entities; not-for-profit institutions.

Number of Respondents and Responses:9,454 respondents; 119,660 responses.

Estimated Time per Response:.50 to 40 hours.

Frequency of Response:Annual, one time, and on occasion reporting requirements; recordkeeping requirement; third-party disclosure requirement.

Obligation to Respond:Mandatory. Statutory authority for this informationcollection is contained in sections 1-4, 255, 303(r), 403, 503, 716, 717, and 718 of the Act, 47 U.S.C. 151-154, 255, 303(r), 403, 503, 617, 618, and 619.

Total Annual Burden:408,695 hours.

Total Annual Cost:$110,588.

Nature and Extent of Confidentiality:Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's system of records notice (SORN), FCC/CGB-1, “Informal Complaints and Inquiries.” As required by the Privacy Act, 5 U.S.C. 552a, the Commission also published a SORN, FCC/CGB-1 “Informal Complaints and Inquiries,” in theFederal Registeron December 15, 2009 (74 FR 66356) which became effective on January 25, 2010.

In addition, upon the service of an informal or formal complaint, a service provider or equipment manufacturer must produce to the Commission, upon request, records covered by 47 CFR 14.31 of the Commission's rules and may assert a statutory request for confidentiality for these records. All other information submitted to the Commission pursuant to Subpart D of Part 14 of the Commission's rules or to any other request by the Commission may be submitted pursuant to a request for confidentiality in accordance with 47 CFR 0.459 of the Commission's rules.

Privacy Impact Assessment:Yes. The Privacy Impact Assessment (PIA) was completed on June 28, 2007. It may be reviewed at:<http://www.fcc.gov/omd/privacyact/Privacy_Impact_Assessment.html>.The Commission is in the process of updating the PIA to incorporate various revisions made to the SORN.

Needs and Uses:On October 7, 2011, in document FCC 11-151, the Commission released aReport and Orderadopting final rules to implement sections 716 and 717 of the Communications Act of 1934 (the Act), as amended, which were added to the Act by the “Twenty-First Century Communications and Video Accessibility Act of 2010” (CVAA).SeePublic Law 111-260, § 104. Section 716 of the Act requires providers of advanced communications services and manufacturers of equipment used for advanced communications services to make their services and equipment accessible to individuals with disabilities, unless doing so is not achievable.See47 U.S.C. 617. Section 717 of the Act establishes new recordkeeping requirements and enforcement procedures for service providers and equipment manufacturers that are subject to sections 255, 716, and 718 of the Act.See47 U.S.C. 618. Section 255 of the Act requires telecommunications and interconnected VoIP services and equipment to be accessible, if readily achievable.See47 U.S.C. 255. Section 718 of the Act requires web browsers included on mobile phones to be accessible to and usable by individuals who are blind or have a visual impairment, unless doing so is not achievable.See47 U.S.C. 619.

Specifically, the rules adopted in document FCC 11-151 have the following possible related information collection requirements:

(a) The rules adopted in document FCC 11-151 establish procedures for advanced communications service providers and equipment manufacturers to seek waivers from the accessibility obligations of section 716 of the Act and, in effect, waivers from the recordkeeping requirements and enforcement procedures of section 717 of the Act. Waiver requests may be submitted for individual or class offerings of services or equipment which are designed for multiple purposes, but are designed primarily for purposes other than using advanced communications services. All such waiver petitions will be put on public notice for comments and oppositions.

(b) The CVAA and the rules adopted in document FCC 11-151 require service providers and equipment manufacturers that are subject to sections 255, 716, or 718 of the Act to maintain records of the following: (1) Their efforts to consult with people with disabilities; (2) descriptions of the accessibility features of their products and services; and (3) information about the compatibility of their products with peripheral devices or specialized customer premises equipment commonly used by individuals with disabilities to achieve access. These recordkeeping requirements are necessary to facilitate enforcement of accessibility obligations. Document FCC 11-151 provides flexibility by allowing covered entities to keep records in any format, recognizing the unique recordkeeping methods of individual entities. Because complaints regarding accessibility of a service or equipment may not occur for years after the release of the service or equipment, covered entities must keep records for two years from the date the service ceases to be offered to the public or the equipment ceases to be manufactured. Service providers and equipment manufacturers are not required to keep records of their consideration of achievability or the implementation of accessibility, but they must be prepared to carry their burden of proof in any enforcement proceeding, which requires greater than conclusory or unsupported claims.

(c) The CVAA and the rules adopted in document FCC 11-151 require an officer of service providers and equipment manufacturers that are subject to sections 255, 716, or 718 of the Act to certify annually to the Commission that records are kept in accordance with the recordkeeping requirements. The certification must be supported with an affidavit or declaration under penalty of perjury, signed and dated by an authorized officer of the entity with personal knowledge of the representations provided in the company's certification, verifying the truth and accuracy of the information. The certification must also identify the name and contact details of the person or persons within the company that are authorized to resolve accessibility complaints, and the agent designated for service of process. The certification must be filed with the Consumer and Governmental Affairs Bureau on or before April 1 each year for records pertaining to the previous calendar year. The certification must be updated when necessary to keep the contact information current.

(d) The Commission also established procedures in document FCC 11-151 to facilitate the filing of formal and informal complaints alleging violations of sections 255, 716, or 718 of the Act. Those procedures include a nondiscretionary pre-filing notice procedure to facilitate dispute resolution. As a prerequisite to filing an informal complaint, complainants must first request dispute assistance from the Consumer and Governmental Affairs Bureau's Disability Rights Office.

The rules adopted in document FCC 11-151 temporarily exempt advanced communications service providers and equipment manufacturers from the accessibility obligations of section 716 of the Act and, in effect, from the recordkeeping requirements and enforcement procedures of section 717 of the Act, if they qualify as small business concerns under the Small Business Administration's (SBA) rules and size standards for the industry in which they are primarily engaged. These size standards are based on the maximum number of employees or maximum annual receipts of a business concern. The SBA categorizes industries for its size standards using the NorthAmerican Industry Classification System (NAICS).

Electronic Access

This final rule is accessible via the Internet at the Office of the Federal Register's Web site athttp://www.gpo.gov/fdsys/search/home.action.Background information and documents are available at the Pacific Fishery Management Council's Web site athttp://www.pcouncil.org/.

The Pacific Coast Groundfish FMP and its implementing regulations at title 50 in the Code of Federal Regulations (CFR), part 660, subparts C through G, regulate fishing for over 90 species of groundfish off the coasts of Washington, Oregon, and California. Groundfish specifications and management measures are developed by the Pacific Fishery Management Council (Council), and are implemented by NMFS.

On November 3, 2010, NMFS published a proposed rule to implement the 2011-2012 harvest specifications and management measures for most species of the Pacific Coast groundfish fishery (75 FR 67810). The final rule to implement the 2011-12 harvest specifications and management measures for most species of the Pacific Coast Groundfish Fishery was published on May 11, 2011 (76 FR 27508). This final rule was subsequently amended by several inseason actions (76 FR 39313, 76 FR 67092, 76 FR 79122, 77 FR 12503, 77 FR 22679). On September 27, 2011, NMFS published a proposed rule to implement final 2012 specifications for overfished species and assessed flatfish species pursuant to Secretarial Amendment 1 to the Groundfish FMP (76 FR 59634). That final rule was effective January 1, 2012. These specifications and management measures are codified in the CFR (50 CFR part 660, subparts C through G).

Changes to current groundfish management measures implemented by this action were recommended by the Council, in consultation with Pacific Coast Treaty Indian Tribes and the States of Washington, Oregon, and California, at its April 1-April 6, 2012 meeting. The Council recommended adjusting the biennial groundfish management measures for the remainder of the biennial period to respond to updated fishery information and additional inseason management needs. The adjustment to fishery management measures are not expected to result in greater impacts to overfished species than originally projected through the end of 2012. Estimated mortality of overfished and target species are the result of management measures designed to achieve, to the extent possible, but not exceed, annual catch limits (ACLs) of target species while fostering the rebuilding of overfished stocks by remaining within their rebuilding ACLs.

In 2011, the amount of sablefish harvested in the limited entry fixed gear sablefish daily trip limit (DTL) fishery North of 36° N. lat. exceeded its sablefish allocation by 60 mt above its collective target (the northern DTL fixed gear share). This did not impact the northern sablefish ACL, since the rationalized Individual Fishing Quota (IFQ) trawl fishery left 148 mt of sablefish un-harvested in the northern area. However, it is expected that since the IFQ fishery participants have one full year of experience in the IFQ fishery, then higher sablefish allocation attainments will be attained, in which case another overage by the northern LE fixed gear could possibly exceed the northern sablefish ACL. To ensure that harvest opportunities for this healthy stock do not exceed the northern LE fixed gear share allocation, the Council considered decreases to trip limits for sablefish in this fishery and the potential impacts on overall catch levels. Landings projections were made by the Council advisory Groundfish Management Team (GMT) for the northern LE fixed gear fishery under the current 2012 trip limit scenario, which projected an overage in the LE North fishery of 16%, or 43 mt. Projections for the other three fixed gear sablefish fisheries were tracking within their targets for 2012.

Therefore, the Council recommended and NMFS is implementing trip limit changes for the limited entry fixed gear fishery North of 36° N. lat. that decrease sablefish DTL fishery limits from “1,300 lb (590 kg) per week, not to exceed 5,000 lb (2,268 kg) of per 2 months” to “1,000 lb (454 kg) per week, not to exceed 4,000 lb (1,814 kg) per 2 months” beginning in period 3, May 1, 2012 through the end of the year. This decrease in trip limits is not anticipated to increase projected impacts to overfished species.

The International Pacific Halibut Commission (IPHC) establishes total allowable catch (TAC) amounts for Pacific halibut each year in January. Under the authority of the Northern Pacific Halibut Act, and implementing regulations at 50 CFR 300.63, a catch sharing plan, developed by the Pacific Council and implemented by the Secretary, allocates portions of the annual TAC among fisheries off Washington, Oregon, and California. The catch sharing plan for Pacific halibut fisheries in Area 2A (waters off the U.S. West coast) allows an incidental total catch limit for halibut for the 2012 sablefish primary season (i.e. tier limit fishery) of 21,173 lb (9,604 kg). This total catch limit of 21,173 lb (9,604 kg) in 2012 is higher than what has been available to the sablefish primary fishery in recent years (2010-11), which was not high enough to justify an incidental catch limit of halibut in the sablefish primary fishery north of Pt. Chehalis, WA (46°53.30′ N. lat.). The retention limits for halibut were not revised as part of the 2011-2012 harvest specifications and management measures because the Total Allowable Catch of halibut for 2012 was not determined until the IPHC meeting in January, 2012. Although the International Pacific Halibut Commission (IPHC) recommended coast-wide catch limits for 2012 totaled 33,540,000 lb (15,213,488 kg), which is a coast-wide decrease of 18.3% from the 2011 catch limit of 41,070,000 lb. (18,629,038 kg), the area 2A allocation increased 8% from 910,000 lb. (412,769 kg) in 2011 to 989,000 lb. (448,603 kg) for 2012. Due to the increase in the Pacific halibut TAC for area 2A, and the resulting increase in the amount of Pacific halibut available to the sablefish primary fishery as incidental take, the Council considered options to revise the catch ratio established in the groundfish regulations at 50 CFR 660.231 at their first opportunity, the March 2012 meeting. These options were developed to reduce incidental impacts to Pacific halibut in the sablefish primary fishery, and stay below the lower 2012 Pacific halibut allocation. After the opportunity for public review and comment, the Council, at their April meeting, made their final recommendation for adjusting the incidental retention limits for Pacific halibut in the sablefish primary fishery in order to allow incidental take and keep mortality of halibut below the 2012 catch limit of 21,173 lb (9,604 kg).

In order to allow incidental halibut catch in the sablefish primary fishery, which is currently not allowed, the Council recommended and NMFS is implementing incidental halibut retention regulations at 50 CFR 660.231(b)(3)(iv) to read as follows: “50 lb (23 kg) dressed weight of halibut for every 1,000 pounds (454 kg) dressed weight of sablefish landed and up to 2 additional halibut in excess of the 50-pounds-per-1,000-pound ratio per landing.”NMFS in including enforcement related provisions recommended by the Council in 2009, the last time an incidental allowance was allowed. Consequently, the landing requirement applies also to possession, and the term “dressed” is described to mean halibut landed eviscerated with their heads on.

These actions are taken under the authority of 50 CFR 660.60(c) and 50 CFR 300.63(b)(3) and are exempt from review under Executive Order 12866.

These increases in sablefish limits are taken under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and are in accordance with 50 CFR part 660, the regulations implementing the FMP. The adjustment to the halibut incidental catch limit in the sablefish primary fishery is taken under the authority of the Northern Pacific Halibut Act and implementing regulations, and is consistent with the approved catch sharing plan. These actions are based on the most recent data available. The aggregate data upon which these actions are based are available for public inspection at the Office of the Administrator, Northwest Region, NMFS, (seeADDRESSES) during business hours.

This final rule makes routine inseason adjustments to groundfish fishery management measures based on the best available information and is taken pursuant to the regulations implementing the Pacific Coast Groundfish FMP.

For the following reasons, NMFS finds good cause to waive prior public notice and comment on the revisions to groundfish management measures under 5 U.S.C. 553(b) because notice and comment would be impracticable and contrary to the public interest. Also, for the same reasons, NMFS finds good cause to waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d)(3), so that this final rule may become effective May 1, 2012.

For the following reasons, NMFS finds good cause to waive prior public notice and comment on the revisions to groundfish management measures under 5 U.S.C. 553(b)(3)(B) because notice and comment would be impracticable and contrary to the public interest. Also, for the same reasons, NMFS finds good cause to waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d)(3), so that this final rule may become effective May 1, 2012.

The recently available information upon which the changes to the incidental halibut retention in the sablefish primary fishery north of Pt. Chehalis, WA (46°53.30′ N. lat.), and the subsequent proposed management measure changes are based were originally provided to the Council, and the Council made its potential recommendations available for public comment, at its March 2-7, 2012 meeting. The Council considered the public comments on this matter as well as additional recently available information upon which the changes to the limited entry fixed gear sablefish trip limits North of 36° N. lat. at its April 1-6, 2012 meeting. At the April Council meeting, the Council recommended that these changes be implemented by May 1, 2012. There was not sufficient time after that meeting to draft this document and undergo proposed and final rulemaking before these actions need to be in effect. For the actions to be implemented in this final rule, affording the time necessary for prior notice and opportunity for public comment would prevent NMFS from managing fisheries using the best available science to approach, without exceeding, the ACLs for federally managed species in accordance with the FMP and applicable laws. The adjustments to management measures in this document affect commercial fisheries off northern California to Washington State. These adjustments to management measures must be implemented in a timely manner, by May 1, 2012, to: Allow fishermen an opportunity to harvest their limits in 2012 for sablefish, and allow incidental catch of halibut in the sablefish primary fishery to keep impacts below the 2012 halibut Area 2A allocation.

Decreases to the sablefish cumulative limits in the limited entry fixed gearfishery continue to allow fishermen opportunities to harvest available healthy stocks while staying within the ACLs for these species. Furthermore, these adjustments to management measures must be implemented in a timely manner to allow limited entry primary sablefish fishermen North of Pt. Chehalis, WA (46°53.30′ N. lat.) to prosecute their intended sablefish fishing strategies while accessing a portion of incidental halibut bycatch in a manner that is consistent with the 2A catch sharing plan. If this rule is not implemented immediately, the public could have incorrect information regarding allowed limited entry fixed gear sablefish trip limits, and allowed fishing activities for groundfish fisheries management, which would cause confusion and be inconsistent with the intent of the Council. It would be contrary to the public interest to delay implementation of these changes until after public notice and comment, because making this regulatory change by May 1, 2012, allows harvest as intended by the Council in fisheries that are important to coastal communities in a manner that prevents ACLs of overfished and target species from being exceeded. Furthermore, changes to the sablefish primary fishery regulations to allow incidental halibut retention limits for the sablefish primary fishery are necessary to reduce halibut impacts in area 2A, keeping total mortality of halibut below the 2012 area 2A allocation. These changes must be implemented in a timely manner by May 1, 2012, to allow sablefish fishermen sustainable incidental take in a manner that prevents early closure of the incidental halibut fishery. It would be contrary to the public interest to wait to implement these changes until after public notice and comment, because a delay in reducing retention limits could cause incidental halibut to be unavailable for harvest for as long as possible throughout the sablefish primary season, which runs through October 31.

No aspect of this action is controversial and no change in operating practices in the fishery is required from those intended in this inseason adjustment.

Delaying these changes would also keep management measures in place that are not based on the best available information. Such delay would impair achievement of the Pacific Coast Groundfish FMP objectives of providing for year-round harvest opportunities, extending fishing opportunities as long as practicable during the fishing year, or staying within ACLs or allocations for Pacific halibut.

Accordingly, for the reasons stated above, NMFS finds good cause to partially waive prior notice and comment and the delay in effectiveness.

For the reasons set out in the preamble, 50 CFR part 660 is amended as follows: