FDA's Center for Veterinary Medicine is adopting use of a monthly Federal Register document to codify approval actions for new animal drug applications (NADAs) and abbreviated new animal drug application (ANADAs). CVM will no longer publish a separate rule for each action. This approach will allow a more efficient use of available resources.

In this document, FDA is amending the animal drug regulations to reflect the original and supplemental approval actions during June 2012, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

The Indian Gaming Regulatory Act (IGRA or Act), Public Law 100-497, 25 U.S.C. 2701 et seq., was signed into law on October 17, 1988. The Act establishes the National Indian Gaming Commission (“Commission”) and sets out a comprehensive framework for the regulation of gaming on Indian lands. The purposes of IGRA include providing a statutory basis for the operation of gaming by Indian Tribes as a means of promoting tribal economic development, self-sufficiency, and strong tribal governments; ensuring that the Indian tribe is the primary beneficiary of the gaming operation; and declaring that the establishment of independent federal regulatory authority for gaming on Indian lands, the establishment of federal standards for gaming on Indian lands, and the establishment of a National Indian Gaming Commission are necessary to meet congressional concerns regarding gaming and to protect such gaming as a means of generating tribal revenue. 25 U.S.C. 2702.

On November 18, 2010, the National Indian Gaming Commission (NIGC) issued a Notice of Inquiry and Notice of Consultation (NOI) advising the public that the NIGC was conducting a comprehensive review of its regulations and requesting public comment on which of its regulations were most in need of revision, in what order the Commission should review its regulations, and the process NIGC should utilize to make revisions. 75 FR 70680 (Nov. 18, 2010). On April 4, 2011, after holding eight consultations and reviewing all comments, NIGC published a Notice of Regulatory Review Schedule (NRR) setting out a consultation schedule and process for review. 76 FR 18457 (Oct. 12, 2011). The Commission's regulatory review process established a tribal consultation schedule with a description of the regulation groups to be covered at each consultation. Part 502 was included in this regulatory review.

The Commission conducted a total of 14 tribal consultations as part of its review of Part 573. Tribal consultations were held in every region of the country and were attended by numerous Tribes and Tribal leaders or their representatives. On June 28, 2011, the Commission requested public comment on a Preliminary Draft of amendments to Part 573.

After considering the comments received from the public and through Tribal consultations, the Commission realized that to supplement the amendments made to Part 573, a definition of “enforcement action” needed to be added to Part 502.

On December 27, 2011, the Commission published a Notice of Proposed Rulemaking based on the comments received during the Tribal consultations and comments on the Preliminary Draft of Part 573. The Notice of Proposed Rulemaking proposed a definition for “enforcement action” be added to Part 502. Following the publication of the proposed rule, an additional 5 Tribal consultations were held. Comments to the proposed rule were due February 27, 2012.

In response to our Notice of Proposed Rulemaking, published December 27, 2011, 76 FR 80846, we received the following comments:

Comment: Two commenters requested that the definition of “enforcement action” be clarified to specifically exclude letters of concern and warning letters. The commenters felt that without such clarification a letter of concern or a warning letter could be considered an “enforcement action.”

Response: The Commission agrees with the commenter that clarification in the regulation is beneficial. To that end, the Commission added a sentence on to the end of the proposed definition of “enforcement action” specifically stating that “[e]nforcement action does not include any action taken by NIGC staff, including but not limited to, the issuance of a letter of concern under § 573.2.” This change does not include a “warning letter” because it was removed by the Commission from the § 573.2 final rule.

Comment: One commenter requested the Commission consider removing “against any person engaged in gaming for a violation of any provision of IGRA, the regulations of this chapter, or tribal regulations, ordinances, or resolutions approved under 25 U.S.C. 2710 or 2712 of IGRA” because adding the statutory language is superfluous and potentially confusing.

Response: The Commission considered the comment and disagrees that the inclusion of a paraphrased portion of the statutory language within the definition causes confusion. To be clear, the language is not an exact quotation of the statutory language; it is a paraphrasing of such language, which helps to ensure that the definition remains consistent with the statute and that the extent of the Chair's authority is clear to the regulated community.

Comment: One commenter recommends that the definition of “Chairman” be amended or changed to indicate that the word “Chair” can be used interchangeably or the word “Chair” should be separately defined.

Response: The Commission intends, as the opportunity to do so arises, to convert all references to the “Chairman” contained in the NIGC regulations to the shortened, gender-neutral word “Chair.” The use of the word “Chair” should not cause confusion as it is only a shortened form of the word “Chairman.”

Comment: One commenter asked whether the definition of “enforcement action” included audit and enforcement of revenue allocation plan requirements because the commenter believes the Commission does not have the authority to do so.

Response: The Commission believes the commenter's question goes beyond the scope of the NOI and NRR and no answer is required. However, the definition of “enforcement action” clearly defines the Commission's authority to enforce violations of any provision of IGRA, NIGC regulations, and any tribal ordinances, resolutions, or regulations that are approved by the Chair under IGRA. Therefore, to the extent IGRA, NIGC regulations, or any tribal ordinances, resolutions, or regulations approved by the Chair under IGRA, create audit obligations or revenue allocation plan requirements, the Chair has the authority to enforce them.

The rule will not have a significant impact on a substantial number of small entities as defined under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Moreover, Indian Tribes are not considered to be small entities for the purposes of the Regulatory Flexibility Act.

The rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. The rule does not have an effect on the economy of $100 million or more. The rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, local government agencies or geographic regions. Nor will the rule have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of the enterprises, to compete with foreign based enterprises.

The Commission, as an independent regulatory agency, is exempt from compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2 U.S.C. 658(1).

In accordance with Executive Order 12630, the Commission has determined that the rule does not have significant takings implications. A takings implication assessment is not required.

In accordance with Executive Order 12988, the Commission has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

The Commission has determined that the rule does not constitute a major federal action significantly affecting the quality of the human environment and that no detailed statement is required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq.

This rule does not require information collection under the Paperwork Reduction Act of 1995, 44 U.S.C. 2501, et seq., and is therefore not subject to review by the Office of Management and Budget.

For the reasons stated in the preamble, the National Indian Gaming Commission amends 25 CFR part 502 as follows:

The Indian Gaming Regulatory Act (IGRA) requires that each person with a financial interest in, or management responsibility for, a management contract for class II gaming, and in the case of a corporation, the individual members of the corporation's board of directors and stockholders who hold 10% or more of the issued and outstanding stock, submit background information to the Chair. 25 U.S.C. 2711(a)(1). IGRA also requires that the Chair not approve any management contract if he or she determines that any person with a financial interest in, or management responsibility for, a management contract for class II gaming, and in the case of a corporation, the individual members of the corporation's board of directors and stockholders who hold 10% or more of the issued and outstanding stock is “a person whose prior activities, criminal record if any, or reputation, habits, and associations pose a threat to the public interest or to the effective regulation and control of gaming, or create or enhance the dangers of unsuitable, unfair, or illegal practices, methods, and activities in the conduct of gaming or the carrying on of the business and financial arrangements incidental thereto.” 25 U.S.C. 2711(e)(1)(D). Pursuant to the Commission's authority to “promulgate such regulations and guidelines as it deems appropriate to implement the provisions of [IGRA],” 25 U.S.C. 2706(a)(10), the Commission adopted a regulation, Part 537, requiring certain persons and entities undergo a background investigation, including entities with a financial interest in a management contract. 25 CFR 537.1(a)(4). The Commission is amending § 537.1(a)(4) to expand the types of entities with a financial interest in a management contract that may, at the discretion of the Chair, undergo a streamlined review, in the form of a reduced scope background investigation.

In addition, it came to the attention of the Commission that it could no longer accept certain methods of payment, specifically the posting of a bond or letter of credit for background investigation fees pursuant to § 537.3(b),(c) and (d). Thus, the Commission is amending § 537.3(b),(c) and (d) to remove the following words: “bond, letter of credit, or.”

On November 18, 2010, the National Indian Gaming Commission (NIGC) issued a Notice of Inquiry and Notice of Consultation (NOI) advising the public that the NIGC was conducting a comprehensive review of its regulations and requesting public comment. 75 FR 70680 (Nov. 18, 2010). After consulting with tribes, NIGC published a Notice of Regulatory Review Schedule (NRR) setting out a consultation schedule and process for review. 76 FR 18457 (Oct. 12, 2011). The Commission's regulatory review process established a tribal consultation schedule with a description of the regulation groups to be covered at each consultation. Part 537 was included in this regulatory review.

The Commission conducted tribal consultations as part of its review of Part 537. Tribal consultations were held in every region of the country and were attended by numerous Tribes and Tribal leaders or their representatives. Comments received from the NRR and tribal consultations included a recommendation for the Commission to consider amending the regulations to provide a more streamlined or expedited background investigation for tribes, tribal entities, and certain other entities already required be licensed pursuant to a tribal-state compact or are otherwise required to undergo a background investigation as a federally regulated entity.

Additionally, during the review of Part 537 the Department of the Interior brought to the attention of the Commission that it could no longer accept certain methods of payment, specifically the posting of a bond or letter of credit for background investigation fees pursuant to § 537.3(b),(c) and (d).

After considering the comments received from the public and through Tribal consultations, the Commission decided to amend Part 537. On June 28, 2011, the Commission requested public comment on a Preliminary Draft of amendments to Part 537.

On December 27, 2011, the Commission published a Notice of Proposed Rulemaking based on the comments received during the Tribal consultations and comments on the Preliminary Draft of Part 537. The Notice of Proposed Rulemaking proposed an expanded list of entities eligible for a reduced scope background investigation at the discretion of the Chair and removed the posting of a bond or letter of credit as an available form of payment for background investigation fees. Following the publication of the proposed rule, an additional 4 Tribal consultations were held. Comments to the proposed rule were due February 21, 2012.

In response to our Notice of Proposed Rulemaking, published December 22, 2011, 76 FR 79565, we received the following comments.

Comment: Several commenters suggested that the Commission remove or define the terms “institutional investor” and “federally regulated” to clarify what entities or institutions would be eligible for a reduced scope background investigation.

Response: The Commission disagrees with the commenters and believes that the terms “institutional investor” and “federally regulated” should remain in the regulation as they provide guidance as to the types of entities meant to be included therein. Also, the Commission believes that any necessary clarification of the terms “institutional investor” or “federally regulated” can be accomplished through guidance in the form of a bulletin rather than through formal regulation.

Comment: Two commenters suggested that the proposed regulation be changed to create a rebuttable presumption that “a tribe, a wholly owned tribal entity, national bank or institutional investor that is federally regulated or is required to undergo a background investigation and licensure by a state or tribe pursuant to a tribal-state compact” qualifies for a reduced scope background investigation.

Response: The Commission believes the commenters' suggestion goes beyond the scope of the NOI and NRR and no answer is required. However, the Commission believes that such a presumption, even if rebuttable by the Chair, would be impermissible because it would be contrary to the express statutory language that requires the Chair obtain background information from a person or an entity with a financial interest in, or management responsibility for, a management contract, and use that information to determine if a management contract can be approved. See 25 U.S.C. 2711(a)(1)(A) and (e).

Comment: Several commenters suggested changing § 537.3(d) to state at the beginning that “any remaining balance of the deposit will be returned to the management contractor * * * ” in order to clarify what specific portion of the deposit, if any, is to be returned to the management contractor.

Response: The Commission agrees with the comment and has added the following to the beginning of § 537.3(d): “[a]ny remaining balance of.”

The rule will not have a significant impact on a substantial number of small entities as defined under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Moreover, Indian Tribes are not considered to be small entities for the purposes of the Regulatory Flexibility Act.

The rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. The rule does not have an effect on the economy of $100 million or more. The rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, local government agencies or geographic regions. Nor will the rule have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of the enterprises, to compete with foreign based enterprises.

The Commission, as an independent regulatory agency, is exempt from compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2 U.S.C. 658(1).

In accordance with Executive Order 12630, the Commission has determined that the rule does not have significant takings implications. A takings implication assessment is not required.

In accordance with Executive Order 12988, the Commission has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

The Commission has determined that the rule does not constitute a major federal action significantly affecting the quality of the human environment and that no detailed statement is required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq.

This rule does not require information collection under the Paperwork Reduction Act of 1995, 44 U.S.C. 2501, et seq., and is therefore not subject to review by the Office of Management and Budget.

For the reasons discussed in the Preamble, the Commission amends 25 CFR part 537 as follows:

The Indian Gaming Regulatory Act (IGRA or Act), Public Law 100-497, 25 U.S.C. 2701 et seq., was signed into law on October 17, 1988. The Act establishes the National Indian Gaming Commission (“Commission”) and sets out a comprehensive framework for the regulation of gaming on Indian lands. The purposes of IGRA include providing a statutory basis for the operation of gaming by Indian Tribes as a means of promoting tribal economic development, self-sufficiency, and strong tribal governments; ensuring that the Indian tribe is the primary beneficiary of the gaming operation; and declaring that the establishment of independent federal regulatory authority for gaming on Indian lands, the establishment of federal standards for gaming on Indian lands, and the establishment of a National Indian Gaming Commission are necessary to meet congressional concerns regarding gaming and to protect such gaming as a means of generating tribal revenue. 25 U.S.C. 2702.

On November 18, 2010, the National Indian Gaming Commission (NIGC) issued a Notice of Inquiry and Notice of Consultation advising the public that the NIGC was conducting a comprehensive review of its regulations and requesting public comment on which of its regulations were most in need of revision, in what order the Commission should review its regulations, and the process NIGC should utilize to make revisions. 75 FR 70680 (Nov. 18, 2010). On April 4, 2011, after holding eight consultations and reviewing all comments, NIGC published a Notice of Regulatory Review Schedule setting out a consultation schedule and process for review. 76 FR 18457. The Commission's regulatory review process established a tribal consultation schedule with a description of the regulation groups to be covered at each consultation. This part 571 was included in the regulatory review.

As part of its review of part 571, the Commission consulted with tribes and tribal leaders or their representatives in every region of the country. Further, on June 28, 2011, the Commission issued a preliminary draft of amendments to Part 571 and requested public comment.

The Notice of Regulatory Review Schedule announced the Commission's intent to review whether part 571 needed revision to clarify the NIGC's authority to access records located off-site, including at sites maintained and owned by third-parties. Comments received by the Commission in response to the Notice of Inquiry expressed the view that NIGC already possessed that authority, that it was clear and that it did not need to be further clarified through regulation. The Commission agreed that further clarification was unnecessary and did not propose changes to that section.

Throughout the review process of this part, the Commission received comments that the regulations should include a process for notifying a tribe that an investigation has been concluded. Tribal representatives explained that in some instances they were never notified of the results of investigations opened by the NIGC years ago. The discussion draft attempted to formalize NIGC's informal process of advising a tribe, through NIGC's authorized representative, after an investigation was terminated. All comments received on the discussion draft were supportive of the concept. However, several comments indicated that such a letter should be mandatory and not discretionary. The Commission believes it is important to provide the Chair with the discretion to make those determinations on a case-by-case basis. The final rule retains that discretion.

After considering the comments received from the public and through tribal consultation, the Commission published a Notice of Proposed Rulemaking on October 12, 2011. The comment period closed on December 12, 2011.

After considering the comments received from the public and through tribal consultation, the Commission published a Notice of Proposed Rulemaking on October 12, 2011. The comment period closed on December 12, 2011.

In response to our Notice of Proposed Rulemaking, published October 11, 2011, 76 FR 63237, we received the following comments.

Comment: Numerous comments support the issuance of an investigation closure letter. Many comments stated the importance of providing some indication when an investigation has been completed and that an enforcement action is no longer active.

Response: The Commission agrees that in some circumstances such a letter may be appropriate.

Comment: One commenter suggested that the issuance of investigation closure letters be mandatory instead of voluntary.

Response: The Commission believes that the Chair should retain discretion in conducting investigations and when staff may indicate that a matter is closed. Therefore, the Commission believes these letters should not be mandatory.

This rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Indian tribes are not considered to be small entities for the purposes of the Regulatory Flexibility Act.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule does not have an annual effect on the economy of $100 million or more. This rule will not cause a major increase in costs or prices for consumers, individual industries, federal, state or local government agencies or geographic regions and does not have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

The Commission, as an independent regulatory agency within the Department of the Interior, is exempt from compliance with the Unfunded Mandates Reform Act. 2 U.S.C. 1502(1); 2 U.S.C. 658(1).

In accordance with Executive Order 12630, the Commission has determined that this rule does not have significant takings implications. A takings implication assessment is not required.

In accordance with Executive Order 12988, the Office of General Counsel has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order.

The Commission has determined that this rule does not constitute a major federal action significantly affecting the quality of the human environment and that no detailed statement is required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq.

This rule does not require information collection under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq., and is therefore not subject to review by the Office of Management and Budget.

Accordingly, for the reasons discussed in the preamble, the Commission amends 25 CFR part 571 as follows:

The Indian Gaming Regulatory Act (IGRA or Act), Public Law 100-497, 25 U.S.C. 2701 et seq., was signed into law on October 17, 1988. The Act establishes the National Indian Gaming Commission (“Commission”) and sets out a comprehensive framework for the regulation of gaming on Indian lands. The purposes of IGRA include providing a statutory basis for the operation of gaming by Indian Tribes as a means of promoting tribal economic development, self-sufficiency, and strong tribal governments; ensuring that the Indian tribe is the primary beneficiary of the gaming operation; and declaring that the establishment of independent federal regulatory authority for gaming on Indian lands, the establishment of federal standards for gaming on Indian lands, and the establishment of a National Indian Gaming Commission are necessary to meet congressional concerns regarding gaming and to protect such gaming as a means of generating tribal revenue. 25 U.S.C. 2702.

On November 18, 2010, the National Indian Gaming Commission (NIGC) issued a Notice of Inquiry and Notice of Consultation (NOI) advising the public that the NIGC was conducting a comprehensive review of its regulations and requesting public comment. 75 FR 70680 (Nov. 18, 2010). After consulting with tribes, NIGC published a Notice of Regulatory Review Schedule (NRR) setting out a consultation schedule and process for review. 76 FR 18457 (Oct. 12, 2011). The Commission's regulatory review process established a tribal consultation schedule with a description of the regulation groups to be covered at each consultation. Part 573 was included in this regulatory review.

The Commission conducted tribal consultations as part of its review of Part 573. Tribal consultations were held in every region of the country and were attended by numerous Tribes and Tribal leaders or their representatives.

After considering the comments received from the public and through Tribal consultations, the Commission proposed amending Part 573 to include a graduated pre-enforcement process whereby a gaming operation may achieve voluntary compliance with the IGRA, Commission regulations or tribal ordinances and resolutions approved by the Chair. Following the publication of the proposed rule, additional Tribal consultations were held. The public comment period on the proposed rule closed on February 27, 2012.

In response to our Notice of Proposed Rulemaking, published December 27, 2011, 76 FR 80847, we received the following comments:

Comment: One commenter argued that, as currently drafted, a warning letter is essentially the same as a notice of violation, except that a warning letter cannot be appealed. The commenter stated that a warning letter would be considered final agency action by a court even though it is issued by NIGC staff rather than the Chair. Therefore, the commenter suggested that the NIGC remove warning letters as a pre-enforcement step because a letter of concern is sufficient to accomplish the Commission's intent to encourage voluntary compliance and resolve any potential enforcement issues. The commenter stated further that because a warning letter contains a finding that a violation has occurred, it could have significant negative repercussions for a tribe that is required to report such actions to lenders or other debt holders, and may also have negative licensing implications for a tribe and its employees.

Response: The Commission agrees with the commenter and has removed warning letters as a pre-enforcement option.

The rule will not have a significant impact on a substantial number of small entities as defined under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Moreover, Indian Tribes are not considered to be small entities for the purposes of the Regulatory Flexibility Act.

The rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. The rule does not have an effect on the economy of $100 million or more. The rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, local government agencies or geographic regions. Nor will the rule have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of the enterprises, to compete with foreign based enterprises.

The Commission, as an independent regulatory agency, is exempt from compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2 U.S.C. 658(1).

In accordance with Executive Order 12630, the Commission has determined that the rule does not have significant takings implications. A takings implication assessment is not required.

In accordance with Executive Order 12988, the Commission has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

The Commission has determined that the rule does not constitute a major federal action significantly affecting the quality of the human environment and that no detailed statement is required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq.

This rule does not require information collection under the Paperwork Reduction Act of 1995, 44 U.S.C. 2501, et seq., and is therefore not subject to review by the Office of Management and Budget.

For the reasons stated in the preamble, the National Indian Gaming Commission amends 25 CFR part 573 as follows:

The Coast Guard will enforce Special Local Regulation for the annual SPORT Boat Races in 33 CFR 100.801(60) on September 21, 2012, from 3 p.m. to 6 p.m. and on September 22 and 23, 2012 from 9 a.m. to 6 p.m.

Under the provisions of 33 CFR 100.801, a vessel may not enter the regulated area, unless it receives permission from the Captain of the Port or his designated on-scene Patrol Commander. Spectator vessels may safely transit outside the regulated area but may not anchor, block, loiter, or impede participants or official patrol vessels. The Coast Guard may be assisted by other federal, state or local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 100.801 and 33 U.S.C. 1233. In addition to this notice in the Federal Register , the Coast Guard will provide the maritime community with notification of this enforcement period via Local Notice to Mariners, Marine Information Broadcasts, and Marine Safety Information Bulletins.

If the Captain of the Port or his designated on-scene Patrol Commander determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

On June 13, 2012 a Notice of Proposed Rule Making (NPRM) was published in 77 FR 35321. We received no comments on the proposed rule. No public meeting was requested, and none was held.

On September 29, 2012 from 7 a.m. to 11 a.m., Without Limits Coaching will sponsor “Swim Harbor Island” on the waters adjacent to and surrounding Harbor Island in Wrightsville Beach, North Carolina. The swim event will consist of up to 200 swimmers swimming a 3.5 mile course around Harbor Island in Wrightsville Beach, North Carolina. To provide for the safety of participants, spectators and other transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during this event.

The Coast Guard is establishing a safety zone on the navigable waters of the Atlantic Intracoastal Waterway 550 yards north and south of the U.S. 74/76 Bascule Bridge, mile 283.1, latitude 34°13′06″ North, longitude 077°48′44″ West, at Wrightsville Beach, North Carolina. Participants will enter the Atlantic Intracoastal Waterway at the Dockside Marina on the west bank of the Atlantic Intracoastal Waterway south of the U.S. 74/76 Bascule Bridge at Wrightsville Beach, North Carolina, and swim north and clockwise around Harbor Island returning to the Dockside Marina. To provide for the safety of participants, spectators and other transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during this event.

In an effort to enhance safety of event participants, the area within the proposed safety zone, will remain closed during the event on September 29, 2012 from 7 a.m. to 11 a.m. In the interest of participant safety, general navigation within the safety zone will be restricted during the specified date and times. Except for participants and vessels authorized by the Coast Guard Captain of the Port or his representative, no person or vessel may enter or remain in the regulated area.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders Although this regulation will restrict access to the area, the effect of this rule will not be significant because the regulated area will be in effect for a limited time, from 7 a.m. to 11 a.m., on September 29, 2012. The Coast Guard will provide advance notification via maritime advisories so mariners can adjust their plans accordingly. The regulated area will apply only to the section of Atlantic Intracoastal Waterway in the immediate vicinity of U.S. 74/76 Bascule Bridge at Wrightsville Beach, North Carolina. Coast Guard vessels enforcing this regulated area can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz).

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit the specified portion of Atlantic Intracoastal Waterway from 7 a.m. to 11 a.m. on September 29, 2012.

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This proposed rule will only be in effect for four hours from 7 a.m. to 11 a.m. The regulated area applies only to the section of Atlantic Intracoastal Waterway in the vicinity of the U.S. 74/76 Bascule Bridge at Wrightsville Beach, North Carolina. Vessel traffic may be allowed to pass through the regulated area with the permission of the Coast Guard Patrol Commander. In the case where the Patrol Commander authorizes passage through the regulated area, vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the swim course. The Patrol Commander will allow non-participating vessels to transit the event area once all swimmers are safely clear of navigation channels and vessel traffic areas. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR Part 100 that apply to organized marine events on the navigable waters of the United States that may have potential for negative impact on the safety or other interest of waterway users and shore side activities in the event area. This special local regulation is necessary to provide for the safety of the general public and event participants from potential hazards associated with movement of vessels near the event area. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

The Route 35 Bridge, across the Cheesequake Creek at mile 0.0, at Morgan, South Amboy, New Jersey, has a vertical clearance in the closed position of 25 feet at mean high water and 30 feet at mean low water. The drawbridge operation regulations are listed at 33 CFR 117.709.

The Coast Guard received a request from the owner of the bridge, New Jersey Department of Transportation, to allow the bridge to remain in the closed position for an hour and a half, 12 p.m. through 1:30 p.m., on September 16, 2012, to facilitate the Rolling Thunder Freedom Ride, public event.

Vessels that can pass under the draw in the closed position may do so at all times. There are no alternate routes available for vessel traffic. The bridge can be opened in the event of an emergency.

Under this temporary deviation the Route 35 Bridge may remain in the closed position between 12 p.m. and 1:30 p.m. on September 16, 2012.

In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Route 35 Bridge, across the Cheesequake Creek at mile 0.0, at Morgan, South Amboy, New Jersey, has a vertical clearance in the closed position of 25 feet at mean high water and 30 feet at mean low water. The drawbridge operation regulations are listed at 33 CFR 117.709.

The Coast Guard published a previous temporary deviation (76 FR 35349) in the Federal Register that allowed the bridge to remain closed from December 1, 2011 through March 31, 2012, to facilitate phase one of a bridge rehabilitation project at the Route 35 Bridge. The first temporary deviation achieved successful results and no problems or complaints were received from the mariners that normally transit Cheesequake Creek.

On June 20, 2012, the owner of the bridge, the New Jersey Department of Transportation, requested a second temporary deviation to facilitate completion of phase two of the bridge rehabilitation construction at the bridge.

The Coast Guard published an article in the Local Notice to Mariners on June 28, 2012, concerning the phase two bridge closure, with a request for public comment due on or before July 16, 2012. No comments were received.

Under this second temporary deviation the Route 35 Bridge may remain in the closed position from December 1, 2012 through March 31, 2013. Vessels that can pass under the draw in the closed position may do so at all times.

In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

A temporary safety zone is needed to establish periods of complete closure and a one way traffic pattern due to dredging operations in the vicinity of Tunica Bend, Lower Mississippi River Mile Markers 291.0 to 295.0. There will be no passing, meeting, or overtaking of any vessel in the channel.

The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.”

Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. The Coast Guard received notice of two groundings occurring on July 5, 2012, and July 9, 2012, at MM 293.3 LMR. Due to the low water and the width of navigational channel the Army Corps of Engineers will be conducting dredging operations in the area. It would be impracticable and contrary to public interest to complete the NPRM process for this rule. Due to the recent groundings and low water, immediate action is necessary to protect vessel traffic from the hazards associated with transiting this area.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause also exists for making this rule effective less than 30 days after publication in the Federal Register . This temporary safety zone is needed to allow the Army Corps of Engineers to conduct dredging operations to prevent further possible groundings due to low water. Delaying the effective date of this safety measure is contrary to the public interest because immediate action is necessary to protect vessel traffic from the hazards associated with transiting this area.

On July 5, 2012, and July 9, 2012, the Coast Guard received reports of two groundings at MM 293.3 LMR in the vicinity of Tunica Bend. To prevent groundings of vessels due to the low water the Army Corps of Engineers will be conducting dredging operations. The river will be restricted to one way vessel traffic from MM 291 to MM 295 LMR. The Coast Guard determined the safety zone is needed to protect vessel traffic transiting in the vicinity of Tunica Bend.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones. To safeguard persons and property from the hazards associated with dredging operations performed on a waterway, the COTP New Orleans will establish a safety zone on the LMR from MM 291.0 to MM 295.0, 7 a.m. July 11, 2012, until 7 a.m. September 1, 2012.

The Captain of the Port New Orleans will implement a Safety Zone on the LMR extending the entire width of the river from MM 291.0 to MM 295.0. When vessels are allowed by the Captain of the Port (COTP), entry into this zone is restricted to one way traffic unless authorized by the COTP New Orleans or a designated representative. Any full closures will be announced via Broadcast Notice to Mariners.

The Captain of the Port New Orleans can be reached at 225-281-2875. The U.S Government Dustpan Dredge JADWIN can be contacted at 601-631-5795 or Channel 67. Mariners will be subject to requirements that will be listed in Marine Safety Information Bulletins from 7 a.m. on July 11, 2012 until 7 a.m. on September 1, 2012, unless the Army Corps of Engineers dredging operations are completed earlier.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

This rule establishes additional safety restrictions necessary for transit on the LMR from MM 291.0 to MM 295.0, in the vicinity of Tunica Bend. These additional safety restrictions do not prevent safe transit through the area. Due to its duration and limited scope, this rule does not pose a significant regulatory impact.

Additionally, notifications of this rule's effective dates and times and any changes to the rule will be made to the marine community through Marine Safety Information Bulletins (MSIB) or Broadcast Notices to Mariners (BNM).

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the LMR between MM 291.0 and MM 295.0 from 7 a.m. on July 11, 2012, until 7 a.m. on September 1, 2012. This safety zone will not have a significant impact on a substantial number of small entities because vessels are still able to transit the area under the established safety restrictions. Additionally, notifications of the safety restrictions and any changes will be made to the marine community through Marine Safety Information Bulletins (MSIB) or Broadcast Notices to Mariners (BNM).

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a temporary safety zone on the Mississippi River to protect vessel traffic from potential safety hazards associated with the Army Corps of Engineers dredging operations. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The USPTO is revising 37 CFR 6.1 to incorporate classification changes and modifications that became effective January 1, 2012, as listed in the International Classification of Goods and Services for the Purposes of the Registration of Marks (10th ed., 2011), published by WIPO. These revisions have been incorporated into the Nice Agreement. As a signatory to the Nice Agreement, the United States adopts these revisions pursuant to Article 1. In addition, the USPTO is revising punctuation and grammar so that it will conform to what appears in the Nice Agreement.

The following changes are noted:

Class 5 is amended to change “dietetic substances adapted for medical use,” to “dietetic food and substances adapted for medical use,” and to add “dietary supplements for humans and animals;” before “plasters.”

Class 7 is amended to insert “automatic vending machines” after the word “eggs.”

Class 9 is amended to insert “compact discs, DVDs and other digital recording media;” after “discs;” and to insert “computer software;” after “computers.” “Automatic vending machines and” is deleted from Class 9; automatic vending machines are classified in Class 7.

Class 18 is amended to replace “umbrellas, parasols and walking sticks” with “umbrellas and parasols; walking sticks.”

Class 24 is amended to replace “bed and table covers” with “bed covers; table covers.”

Classes 30 and 31 are amended to reorder the manner in which the goods are listed in the class.

Class 32 is amended to replace “non-alcoholic drinks; fruit drinks” with “non-alcoholic beverages; fruit beverages.”

Administrative Procedure Act: The amendments in this final rule are procedural in nature as they only reorganize the international classifications of goods and services and modify the form of wording. The reorganization and modification have been established by the Committee of Experts of the Nice Union and have been promulgated in the volume entitled International Classification of Goods and Services for the Purposes of the Registration of Marks (10th ed., 2011). Therefore, prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553(b)(A), or any other law. Furthermore, pursuant to 5 U.S.C. 553(b)(B), notice and an opportunity for public comment are unnecessary since the amendments are required by the Nice Agreement, to which the United States is a signatory.

Regulatory Flexibility Act: The final rule involves rules of agency practice and procedure. As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are inapplicable.

Executive Order 12866: This rule has been determined not to be significant for purposes of Executive Order 12866 (Sept. 3, 1993).

Executive Order 13563: The USPTO has complied with Executive Order 13563. Specifically, the USPTO has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) provided the public with a meaningful opportunity to participate in the regulatory process, including soliciting the views of those likely affected prior to issuing a notice of proposed rulemaking, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes, to the extent applicable.

Executive Order 13132: This rule does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), prior to issuing any final rule, the United States Patent and Trademark Office will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this notice are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this notice is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

Unfunded Mandates Reform Act of 1995: The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

Paperwork Reduction Act: This final rule does not involve information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

For the reasons stated in the preamble and under the authority contained in 15 U.S.C. 1112, 1123 and 35 U.S.C. 2, as amended, the USPTO is amending part 6 of title 37 as follows:

Throughout this document, the terms “we,” “us,” and “our” refer to EPA.

On April 12, 2012 (77 FR 21913), EPA proposed to approve in part and disapprove in part a SIP revision submitted by Hawaii Department of Health (HDOH) on December 14, 2011 to address the infrastructure requirements of CAA section 110(a)(2) for the 1997 8-hour ozone NAAQS and the 1997 and 2006 NAAQS for PM 2.5 (“2011 Hawaii Infrastructure SIP”). The rationale supporting EPA's action, including the scope of infrastructure SIPs in general, is explained in that Notice of Proposed Rulemaking (NPR) and the associated technical support document (TSD) and will not be restated here. The TSD is available online at http://www.regulations.gov , Docket ID number EPA-R09-OAR-2012-0228. No public comments were received on the NPR.

EPA is approving in part and disapproving in part the 2011 Hawaii Infrastructure SIP. EPA is approving the 2011 Hawaii Infrastructure SIP with respect to the following requirements:

• Section 110(a)(2)(A): Emission limits and other control measures.

• Section 110(a)(2)(B): Ambient air quality monitoring/data system.

• Section 110(a)(2)(C) (in part): Program for enforcement of control measures and regulation of new stationary sources (minor New Source Review (NSR) program only).

• Section 110(a)(2)(D)(i)(I): Interstate transport (significant contribution and interference with maintenance).

• Section 110(a)(2)(E): Adequate resources and authority, conflict of interest, and oversight of local governments and regional agencies.

• Section 110(a)(2)(F): Stationary source monitoring and reporting.

• Section 110(a)(2)(G): Emergency episodes.

• Section 110(a)(2)(H): SIP revisions.

• Section 110(a)(2)(J) (in part): Public notification.

• Section 110(a)(2)(K): Air quality modeling and submission of modeling data.

• Section 110(a)(2)(L): Permitting fees.

• Section 110(a)(2)(M): Consultation/participation by affected local entities.

In addition, we are approving into the SIP as non-regulatory materials the statutory provisions that HDOH included as part of the 2011 Hawaii Infrastructure SIP.

We are disapproving the 2011 Hawaii Infrastructure SIP with respect to the following infrastructure SIP requirements:

• Section 110(a)(2)(C) (in part): Program for enforcement of control measures and regulation of new stationary sources (permit program as required in part C of title I of the Act).

• Section 110(a)(2)(D)(i)(II): Interstate transport—prevention of significant deterioration and visibility protection.

• Section 110(a)(2)(D)(ii): Interstate pollution abatement and international air pollution.

• Section 110(a)(2)(J) (in part): Consultation with government officials and Prevention of Significant Deterioration (PSD).

As explained in the NPR and TSD, our disapproval of these elements and sub-elements is compelled by the absence of an approvable SIP revision from Hawaii that meets the PSD requirements of sections 160 through 165 of the CAA. 1 In addition, our disapproval of Section 110(a)(2)(D)(i)(II) is compelled by the lack of approvable SIP revisions to address reasonably attributable visibility impairment (RAVI) and regional haze affecting mandatory Class I areas. 2 Under section 179(a) of the CAA, final disapproval of a submittal that addresses a requirement of part D, title I of the CAA (CAA sections 171-193) or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP Call) starts a sanctions clock. The 2011 Hawaii Infrastructure SIP was not submitted to meet either of these requirements. Therefore, this action does not trigger sanctions.

In addition, these deficiencies have previously been addressed through promulgation of a PSD federal implementation plan (FIP) (43 FR 26410, June 19, 1978, as amended at 45 FR 52741, August 7, 1980; 68 FR 11322, March 10, 2003; 68 FR 74488, December 24, 2003) and a FIP addressing RAVI (50 FR 28553, July 12, 1985, as amended at 52 FR 45137, November 24, 1987). EPA has proposed a FIP to address regional haze in Hawaii (77 FR 31692, May 29, 2012) and is required to take final action on this FIP (or fully approve a Regional Haze SIP) by September 15, 2012. 3 Therefore, this disapproval does not trigger any new FIP obligations.

As explained in the NPR, this action does not address section 110(a)(2)(C) to the extent it refers to permit programs required under part D (nonattainment NSR), or section 110(a)(2)(I), which pertains to the nonattainment planning requirements of part D of Title I of the CAA.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b).

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant impact on a substantial number of small entities because SIP approvals and partial approvals/partial disapprovals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because this partial approval/partial disapproval action does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of State action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the partial approval/partial disapproval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

Executive Order 13132, Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that 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.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a State rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 does not apply to this rule.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045, because it approves a State rule implementing a Federal standard.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA lacks the discretionary authority to address environmental justice in this rulemaking. In reviewing SIP submissions, EPA's role is to approve or disapprove state choices, based on the criteria of the Clean Air Act. Accordingly, this action merely approves certain State requirements for inclusion into the SIP under CAA section 110 and subchapter I, part D and disapproves others, and will not in-and-of itself create any new requirements. Accordingly, it does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898.

The Congressional Review Act, 5 U.S.C. section 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 804(2). This rule will be effective on October 9, 2012.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 9, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

Therefore, 40 CFR part 52 is amended as follows:

On June 18, 2012, 77 FR 36163, EPA published a final rulemaking action announcing our approval of four separate and independent determinations related to the New York-Northern New Jersey-Long Island (NY-NJ-CT) one-hour and 1997 eight-hour ozone nonattainment areas. In that document, § 52.1576 of title 40 of the Code of Federal Regulations (CFR) was amended, but the amendatory instructions inadvertently designated an existing paragraph incorrectly as (a) and incorrectly reserved paragraph (b). The intent of the rule was to retain the amendments as promulgated on May 16, 2012, 77 FR 28782 and add two new paragraphs (c) and (d) pursuant to the June 18, 2012, 77 FR 36163. This action corrects the erroneous paragraph designations. For the convenience of the reader, and to ensure it reads correctly, the entire § 52.1576 is set out in the regulatory text of this document.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because we are merely correcting an incorrect citation in a previous action. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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 the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 9, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rule we are approving with the date that it was amended by the local air agency and submitted by the California Air Resources Board (CARB).

On March 13, 2012, EPA determined that the submittal for SMAQMD Rule 101 met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

We approved an earlier version of Rule 101 into the SIP on March 19, 1999 (adopted October 27, 1998).

Section 110(a) of the CAA requires states to submit regulations that control volatile organic compounds, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. This rule was developed as part of the local agency's program to control these pollutants.

Sacramento Rule 101, General Provisions and Definitions, is being amended to update the Exempt Compounds list to conform to the Exempt Compounds list of the EPA.

EPA's technical support document (TSD) has more information about this rule.

This rule describes administrative provisions and definitions that support emission controls found in other local agency requirements. In combination with the other requirements, these rules must be enforceable (see section 110(a) of the Act) and must not relax existing requirements (see sections 110(l) and 193). EPA policy that we used to evaluate enforceability requirements consistently includes the Bluebook (“Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988) and the Little Bluebook (“Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001).

We believe this rule is consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rule because we believe it fulfills all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rule. If we receive adverse comments by September 10, 2012, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on October 9, 2012. This will incorporate this rule into the federally enforceable SIP.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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 the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 9, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

Table of Contents I. The State's Submittal A. What rules did the State submit? B. Are there other versions of these rules? C. What is the purpose of the submitted rules? II. EPA's Evaluation and Action A. How is EPA evaluating the rules? B. Do the rules meet the evaluation criteria? C. EPA recommendations to further improve the rules. D. Public Comment and Final Action III. Statutory and Executive Order Reviews I. The State' Submittal A. What rules did the State submit?

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

We approved an earlier version of MDAQMD Rule 1116 into the SIP on April 10, 2000 (65 FR 18901). No other version of SDCAPCD Rule 66.1 or Northern Sierra Rule 228 has been submitted, although EPA previously approved SDCAPCD Rule 66. An earlier version of SMAQMD Rule 459 was approved into the SIP on November 13, 1998 (63 FR 63410).

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires States to submit regulations that control VOC emissions by limiting VOC content in coatings used for metal parts and products, miscellaneous uses, automobile refinishing processes and automotive equipment, parts and compounds. In addition, the rules also limit emission of VOCs by regulating organic solvent cleaning, storage and disposal relating to the coating operations. EPA's technical support documents (TSDs) have more information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the Act), and must not relax existing requirements (see sections 110(1) and 193). In addition, SIP rules must implement Reasonably Available Control Measures (RACM), including Reasonably Available Control Technology (RACT), in moderate and above ozone nonattainment areas. Guidance and policy documents that we use to evaluate enforceability and RACT requirements consistently include the following:

We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT and SIP relaxations. The TSDs have more information on our evaluation.

The TSDs describe additional rule revisions that we recommend for the next time the local agency modifies the rules.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by September 10, 2012, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on October 9, 2012. This will incorporate these rules into the federally enforceable SIP.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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 the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 9, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b) (2)).

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide 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. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010-0637 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0637, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of October 27, 2010 (75 FR 66092) (FRL-9218-2), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E7748) by IR-4 Project Headquarters, Rutgers, the State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.205 be amended by establishing tolerances for residues of the dessicant, defoliant, and herbicide paraquat dichloride, (1,1′-dimethyl-4,4′-bipyridinium-ion) derived from application of either the bis(methyl sulfate) or the dichloride salt (both calculated as the cation), in or on the following perennial tropical and subtropical fruit trees: Sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, lychee, longan, Spanish lime, rambutan, pulasan, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit (carambola), pawpaw, pomegranate, and white sapote at 0.05 parts per million (ppm). That notice referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for paraquat including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with paraquat follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Paraquat is severely toxic following acute exposure via the dermal and inhalation routes and only slightly less toxic by the oral route of exposure. It is a dermal and ocular irritant but is not a skin sensitizer.

The primary target organ of paraquat is the lung. Evidence of lung inflammation, scarring, and compromised lung function in response to paraquat are observed throughout the toxicity database in different species (rats, mice, and dogs). Effects in the respiratory tract are observed after acute, subchronic, and chronic exposures regardless of the route of exposure (oral or inhalation). However, inhalation was a more sensitive route of exposure than the oral route. With increasing durations of exposure, effects of paraquat in other organ systems are observed. These effects include liver inflammation and necrosis in rats and inflammation and necrosis of the kidneys in rats and mice. Lenticular changes in the eyes of rats were also observed with increasing durations of exposure. Importantly, the lung effects occur at doses lower than effects in these other organs systems, and so protecting for lung effects protects for all other adverse effects of paraquat.

The effects of paraquat in lungs are considered systemic effects. There are no dermal toxicity studies suitable for evaluation of systemic lung effects in the toxicity database for paraquat. Therefore, the Agency is using a dermal absorption factor of 0.3%, which was derived from dermal absorption studies conducted in humans and monkeys and an oral endpoint for dermal risk assessments.

Paraquat does not cause reproductive toxicity. Developmental toxicity in response to paraquat, when observed, always occurred in the presence of maternal toxicity. Four developmental toxicity studies (two in rats and two in mice) are available. Since effects in the offspring (e.g., reduced body weight/gain and delayed skeletal ossification), when present, were lesser in severity than those observed in maternal animals (e.g., respiratory distress, reduced body weight, lesions in the lungs and kidneys) and were also consistent with those commonly observed as secondary to maternal toxicity, the Agency has concluded that there was no evidence of qualitative susceptibility in the young.

Previously, the Agency had required that a developmental toxicity study in rabbits be conducted for paraquat. As a result, the Food Quality Protection Act (FQPA) Safety Factor (SF) had been retained as a 3X database uncertainty factor for Females 13-39 years old for the acute dietary risk assessment only. The Agency recently reviewed the toxicity database for paraquat and concluded that a developmental toxicity study in rabbits was not likely to add information that would impact the paraquat risk assessment. Therefore, this study is no longer required and the FQPA Safety Factor has been reduced to 1X for this population.

No evidence of neurotoxicity was observed in acute and subchronic neurotoxicity studies conducted with paraquat up to the doses at which respiratory effects were observed (e.g. the maximum tolerated dose). There was also no evidence of immunotoxicity in response to paraquat.

Based on the lack of evidence of carcinogenicity in mice and rats, the Agency has concluded that there is no concern for the carcinogenic potential of paraquat. Paraquat was not mutagenic in the Salmonella typhimurium assay, was not genotoxic in the unscheduled DNA synthesis assay in vitro or in vivo, was negative for chromosomal aberration in the bone marrow test, and no evidence was found for suppressed fertility or dominant lethal mutagenicity in mice. Conversely, paraquat was found to be weakly positive in the mouse lymphoma assay and human lymphocyte cytogenetic assay, and was positive in the sister chromatid exchange assay.

Specific information on the studies received and the nature of the adverse effects caused by paraquat as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Paraquat Dichloride. Human Health Risk Assessment for the Request to Add Uses on Perennial Tropical and Sub-Tropical Fruit Trees” on pps. 31-35 in docket ID number EPA-HQ-OPP-2010-0637.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for paraquat used for human risk assessment is shown in the following table.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to paraquat, EPA considered exposure under the petitioned-for tolerances as well as all existing paraquat tolerances in 40 CFR 180.205. EPA assessed dietary exposures from paraquat in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for paraquat. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, the acute analysis assumed a distribution of residues based on tolerance level residues. Empirical and Dietary Exposure Evaluation Model (DEEM) default processing factors were used to modify the field trial data. Maximum screening-level percent crop treated (PCT) estimates were used for commodities for which data were available. If no PCT data were available, 100 PCT was assumed.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance level residues and average estimates of PCT.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that paraquat does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and PCT information. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency estimated the PCT in the chronic dietary risk assessment for existing uses as follows: Alfalfa, 1%; almonds, 25%; apples, 20%; apricots, 10%; artichokes, 25%; asparagus, 10%; avocados, 2.5%; barley, 1%; green beans, 1%; blackberries, 30%; blueberries, 10%; broccoli, 1%; cabbage, 2.5%; caneberries, 45%; cantaloupes, 5%; carrots, 2.5%; celery, 1%; cherries, 20%; corn, 2.5%; cotton, 15%; cucumbers, 5%; dry beans/peas, 2.5%; summer fallow, 1%; garlic, 1%; grapefruit, 2.5%; grapes, 20%; kiwifruit, 30%; lemons, 2.5%; lettuce, 1%; nectarines, 10%; olives, 5%; onions, 5%; oranges, 5%; pasture, 1%; pastureland, 1%; peaches, 30%; peanuts, 20%; pears, 10%; green peas, 1%; pecans, 5%; peppers, 10%; pistachios, 25%; plums, 15%; potatoes, 5%; prunes, 10%; pumpkins, 5%; raspberries, 70%; rice, 1%; sorghum, 1%; soybeans, 1%; spinach, 5%; squash, 5%; strawberries, 10%; sugar beets, 1%; sugarcane, 5%; sunflowers, 1%; sweet corn, 2.5%; tangelos, 10%; tangerines, 10%; tobacco, 1%; tomatoes, 5%; walnuts, 15%; watermelons, 5%; wheat, 1%.

In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which may be applied in a particular area.

2. Dietary exposure from drinking water. In the past the EPA has concluded that though paraquat undergoes minimal degradation in the environment, and thus is very persistent (as parent), paraquat residues are not expected in surface or ground water. Paraquat has a very high propensity to bind to solids, particularly clay, which makes it very immobile. In addition, paraquat does not readily appear to desorb from clay. The greatest cause for concern is likely to be erosion of contaminated sediments off-site and subsequent redeposition onto non-target areas (especially surface water bodies). Because of its very low mobility and strong tendency to bind tightly to soils, paraquat contamination of drinking water supplies derived from groundwater is expected to be highly unlikely. In addition, the strong binding characteristics of paraquat dichloride are likely to render most residues in raw drinking water sources removable through sedimentation processes, which are typically included as part of standard drinking water treatments.

Because of its strong cation-exchange sorption to soils, modeling is not appropriate for paraquat. In most circumstances, the levels of paraquat residues in surface or ground water are expected to be insignificant. Because it should sorb to suspended sediment, coagulation and flocculation processes in drinking water treatment plants are likely to remove any paraquat dichloride residues present in the raw water. Residues of paraquat dichloride in drinking water derived from surface supplies can therefore be assumed to be negligible.

In order to determine the most appropriate and realistic drinking water numbers to use in the human health risk assessment, the Agency reviewed a non-guideline supplemental mobility study that was conducted to evaluate the effects of traditional water treatment processes on paraquat and to determine the mobility of paraquat through soil filtration column. 14 C-paraquat, spiked at ~30 parts per billion (ppb) into the raw surface water samples from five representative U.S. community water supply facilities, was effectively removed by a combination of typical water treatment processes conducted on a laboratory-scale: The “laboratory jar test” (coagulation using alum with either lime or soda ash, flocculation and sedimentation), followed by duel media filtration (anthracite atop of filtering sand). The combination process was able to reduce the level of 14 C-paraquat to approximate or below the limit of detection of approximately 0.15 microgram/per liter ( μ g/L) ppb. The level of paraquat in the finished water of 0.15 ppb was used in both the acute and chronic assessments.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Paraquat is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found paraquat to share a common mechanism of toxicity with any other substances, and paraquat does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that paraquat does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Prenatal developmental studies in rats and mice show that developmental effects only occur in the presence of maternal toxicity. No effect on reproduction was observed. Fetal effects were limited to delayed ossification and decreased body weights. There was no indication from these studies that paraquat dichloride is involved in endocrine disruption.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for paraquat is complete.

ii. There is no indication that paraquat is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that paraquat results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary exposure analysis is based on tolerance level residues and maximum estimates of PCT. The chronic analysis is based on tolerance level residues and average estimates of percent crop treated. For estimating levels of paraquat in drinking water, the Agency relied on a study that evaluated the effects of traditional water treatment processes on paraquat. These assessments will not underestimate the exposure and risks posed by paraquat.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to paraquat will occupy 21% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to paraquat from food and water will utilize 14% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for paraquat.

3. Short- and Intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short- and intermediate-term adverse effect was identified; however, paraquat is not registered for any use patterns that would result in short- and/or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- and intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- and intermediate-term risk), no further assessment of short- and intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for paraquat.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, paraquat is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to paraquat residues.

An adequate spectrophotometric method, Method I of the Pesticide Analytical Manual (PAM) Vol. II, is available for enforcing tolerances for residues of paraquat in/on plant commodities.

The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for paraquat in or on assorted tropical and subtropical fruits-inedible peel (includes all except atemoya, biriba, jaboticaba, starfruit, and wax jambu) at 0.01 ppm. These MRLs are different from the tolerances being established for paraquat in the United States. The Agency cannot harmonize with the Codex MRL because there were residues greater than 0.01 ppm in some of the data on which the proposed U.S tolerances are based.

Therefore, tolerances are established for residues of paraquat dichloride, (1,1′-dimethyl-4,4′-bipyridinium-ion) derived from application of either the bis(methylsulfate) or the dichloride salt (both calculated as the cation), in or on the following: Sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, lychee, longan, Spanish lime, rambutan, pulasan, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit (carambola), pawpaw, pomegranate, and white sapote at 0.05 ppm.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. 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). Because this final rule has been exempted from review under Executive Order 12866, this final rule 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) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to 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).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

We published a notice of policy and a request for comments that outlined the procedures by which classification societies could apply for approval with the Coast Guard. See 69 FR 63548 (November 2, 2004). This notice of policy was based on the August 9, 2004 enactment of Section 413 of the Coast Guard and Maritime Transportation Act of 2004 (“the 2004 Act”) (Pub. L. 108-293). The 2004 Act amended 46 U.S.C. 3316 by adding paragraph (c), which prohibits certain activities on a vessel in the United States by classification societies that have not been approved by the Coast Guard. The 2004 Act mandated that, after December 31, 2004, a classification society, including an employee or agent of that society, may not review, examine, survey, or certify the construction, repair, or alteration of a vessel in the United States unless the classification society is either approved by the Coast Guard or is a full member of the International Association of Classification Societies (IACS).

After publication of the notice of policy, we received two questions from the public that were addressed in a Notice of Proposed Rulemaking (NPRM) published in the Federal Register on April 23, 2010. The NPRM, entitled “Approval of Classification Societies” (75 FR 21212), outlined the procedures and criteria we would use to evaluate classification societies. The comment period closed on July 22, 2010, and we received no comments on the proposed rule. No public meeting was requested and none was held.

On October 15, 2010, the enactment of section 622 of the Coast Guard Authorization Act of 2010 (the “2010 Act”) (Pub. L. 111-281) amended 46 U.S.C. 3316(c). The 2010 Act changed the provision's applicability to require all classification societies, including IACS members, to be approved by the Coast Guard prior to conducting any work on a vessel in the United States. Because of the 2010 Act's applicability changes, we reopened the comment period to allow for any additional or updated comments from the public on our plan to remove the proposed rule's exemption for IACS members, and apply the proposed rule to all classification societies seeking Coast Guard approval, including IACS members. See 76 FR 47531 (August 5, 2011). The comment period closed on September 6, 2011, and 4 commenters with 11 comments responded to the revised proposal. No public meeting was requested and none was held.

This final rule codifies into Title 46 of the Code of Federal Regulations (CFR) the procedures and criteria to evaluate classification societies in accordance with 46 U.S.C. 3316(c) in order to have a specific, consistent, and enforceable basis for approval determinations.

To incorporate the requirements of 46 U.S.C. 3316(c) into regulations, we deem the International Maritime Organization (IMO) Resolution A.739(18), “Guidelines for the Authorization of Organizations Acting on Behalf of the Administration,” to provide a sound and internationally recognized standard on which to base our classification society review and approval program.

The IMO acknowledges that a classification society often acts as a Recognized Organization (RO) under authority delegated by a flag state administration when it performs technical and survey work on behalf of that administration. Recognizing this relationship, IMO Resolution A.739(18) adopted guidelines for minimum competency standards for ROs that act on behalf of flag state administrations to conduct vessel examinations, issue international certificates, perform surveys and certifications, and determine vessel tonnage in accordance with applicable international requirements. In addition, the IMO guidelines are consistent with our minimum standards for a classification society to qualify as a Coast Guard-recognized organization in accordance with 46 CFR part 8, “Vessel Inspection Alternatives.”

To perform work on behalf of a flag state administration that uses the IMO guidelines, an RO must sufficiently demonstrate that its business practices meet or exceed the performance standards described in IMO Resolution A.739(18). For example, the RO must show that it—

• Publishes and systematically maintains rules for the design, construction, and certification of vessels;

• Is professionally staffed with strategically placed resources for geographic coverage;

• Maintains a high level of professional ethics;

• Is competent;

• Provides timely and quality services; and

• Maintains an internal quality system no less effective than the International Organization for Standardization (ISO) 9000 series certification. (For information on these standards or on ISO, see www.iso.ch.)

When an RO demonstrates these competencies to the satisfaction of the flag state administration, its authorization is documented by that administration in a formal written agreement under the recommendations of IMO Resolution A.739(18).

Similarly, all classification societies must meet the following requirements for approval under the provisions of 46 U.S.C. 3316(c):

• Vessels surveyed by the classification society must have an adequate safety record.

• The classification society must have an adequate program to—

○ Develop and implement safety standards for the vessels it surveys;

○ Make its safety records available in an electronic format;

○ Make the safety records of a vessel survey available to other classification societies; and

○ Request safety records from other classification societies that previously surveyed a vessel for the purpose of a specific vessel survey.

To better assess classification societies, we evaluate how these societies implement safety standards for vessels by examining worldwide port state control statistics for each society and the vessels it surveys. These data normally appear in annual reports published by the world's regional port state control organizations. Some of these annual reports are not available online. These organizations include, but are not limited to, the following organizations created under regional memoranda of understanding (MOU):

• Paris Memorandum of Understanding on Port State Control (Paris MOU: www.parismou.org ).

• Memorandum of Understanding on Port State Control in the Asian-Pacific Region (Tokyo MOU: www.tokyo-mou.org ).

• Mediterranean Memorandum of Understanding on Port State Control (Med MOU: www.medmou.org ).

• Black Sea Memorandum of Understanding on Port State Control (Black Sea MOU: www.bsmou.org ).

• The Latin American Agreement on Port State Control of Vessels (Vina del Mar MOU: www.acuerdolatino.int.ar ).

• West and Central Africa Memorandum of Understanding on Port State Control (Abuja MOU: www.abujamou.org ).

• Riyadh Memorandum of Understanding on Port State Control in the Gulf Region (Riyadh MOU: www.riyadhmou.org ).

• Indian Ocean Memorandum on Port State Control (Indian Ocean MOU: www.iomou.org ).

• Caribbean Memorandum of Understanding on Port State Control (Caribbean MOU: www.caribbeanmou.org ).

These MOU are regional agreements among countries to share port state control inspection results with the aim of eliminating the operation of substandard ships. Typically, MOU are managed by secretariats that maintain databases of inspection activities and results and often compile the data into annual reports. The annual reports normally compiled by the MOU secretariats are available to the public and identify, among other things—

• Vessel names and particulars;

• Inspection dates and locations;

• Classification societies;

• Deficiencies noted;

• Detentions imposed;

• Detained vessels; and

• Banned and targeted vessels.

For information on U.S. port state control results and the regional MOUs, see www.uscg.mil/hq/g-m/pscweb/index.htm. A copy of the most recent annual report from the United States and the regional organizations can be found in this docket.

We can evaluate the performance of a particular classification society by scrutinizing the port state control history of the vessels it surveys. For example, an annual report from a major MOU secretariat typically includes 3 years of data showing the performance of all ships listed by administration and RO. The RO is usually a classification society.

These shared port state control data are indispensable in evaluating the safety performance of flag state administrations and classification societies. Not only can we check performance from the data in the annual reports, we can also track trends from year to year.

We received no comments from the NPRM published on April 23, 2010. Since the publication of the NPRM, the 2010 Act required all classification societies, without exemption, to seek Coast Guard approval prior to working on a vessel located in the United States. Accordingly, we reopened the comment period (76 FR 47531).

We received 11 comments from 4 commenters in response to the NPRM after the reopening of the comment period.

Two commenters requested that a classification society that has qualified as a Coast Guard-recognized organization under 46 CFR part 8 to conduct work on behalf of the Coast Guard on U.S. flagged vessels be exempted from the proposed rule. We have determined that we lack the authority to grant wholesale exemptions to the requirement in 46 U.S.C. 3316(c)(1) that every classification society “appl[y] for approval under this subsection,” and that section 3316(c)(2) requires us to “review[] and approve[] that society” under that subsection.

However, we will deem compliance with the application procedures in 46 CFR part 8 to satisfy the new application procedures under new 46 CFR subpart 2.45 promulgated by this rule. Consistent with the statute, we are requiring any Coast Guard-RO seeking approval as a classification society under this rule to explicitly request that the Coast Guard evaluate their 46 CFR part 8 application materials under this rule as well. Upon receiving such notice, we will treat the part 8 application materials as an application under this subpart. If we need additional information to perform our review, we will take the appropriate action to notify the classification society and give them an opportunity to submit the information to us.

One commenter requested that his or her organization be automatically approved under 46 U.S.C. 3316(c)(1) and under the proposed rule. The commenter argued that such approval was justified because the organization is identified in 46 U.S.C. 3316(a) by name as an agent on behalf of the U.S. Government in classifying vessels owned by the Government. Also, the organization is recognized by the Coast Guard and authorized as a recognized organization of the Coast Guard pursuant to the requirements of Coast Guard regulations in 46 CFR part 8 pursuant to 46 U.S.C. 3316(b)(1).

We agree with the commenter that the organization is identified as the sole classification society for U.S. Government-owned vessels. However, based on the reasoning previously stated, we cannot automatically approve any organization as a classification society. Section 3316(c)(1) of 46 U.S.C. requires that every classification society make application to the Coast Guard for approval and that the Coast Guard assess the conduct of the classification society under 46 U.S.C. 3316(c)(2). An automatic approval would violate both the application requirement and the assessment requirement. As stated above, however, we will deem compliance with the application procedures in 46 CFR part 8 to satisfy the new application procedures under new 46 CFR subpart 2.45, provided each applicant submits indication that they all wish to be assessed under the new regulations in 46 CFR subpart 2.45 to become an approved classification society.

Additionally, the same commenter asked that we clarify in the final rule whether the detention rate is based on all vessel detentions or specifically RO-related detentions. We agree that clarification is necessary. An RO detention occurs when a vessel is detained due to a deficiency which is the result of an activity by an RO. Therefore, we will amend the regulatory text to specify that the detention rate is based specifically on RO-related detentions.

One commenter felt that the final rule does not list clear or specific criteria for annually reevaluating the records of classification societies to ensure they continue to meet the conditions for approval. The same commenter also stated that if the re-evaluation criteria include data from global port state control regimes, then some previously approved classification societies would have poorer records than some classification societies that are not approved. The same commenter expressed the hope that the requirement in § 2.45-15 would not amount to annual auditing of classification societies performance processes.

We agree that the proposed rule did not explicitly list the criteria for annually reevaluating the performance of a classification society. However, as stated in the NPRM (see 75 FR page 21215), we will “annually reevaluate the records of approved classification societies to ensure they continue to meet the conditions for approval.” It was and remains our intention to use the approval requirements listed in § 2.45-15 to annually reevaluate the performance of approved classification societies. We also agree that it is possible for us to find during a re-evaluation that an approved classification society has a poor performance record based on data collected from global port state control regimes. If we determine that a previously approved classification society no longer meets the requirements in § 2.45-15, then we will take corrective action per § 2.45-20.

While we appreciate the commenter's concern, annual review of a classification society's performance is necessary to ensure that the classification society is in compliance with the requirements set forth in the regulations.

One commenter had six comments, discussed as follows.

The commenter asked that we clarify the scope of “repair” in light of the fact that repairs to the hull, equipment, and machinery can be made at any time as a result of an accident or survey work. Repair includes, but is not limited to, any work done to the hull, equipment, or machinery that restores the item to its original design or intended operating condition.

The commenter requested that we clarify whether a classification society would be allowed to conduct surveys “whether they be periodical (annual, intermediate and renewal) or occasional and to issue certificates even if they are not approved by the Coast Guard.” A classification society that is not approved by the Coast Guard would be permitted to conduct surveys and issue certificates to a vessel if that vessel is not undergoing or has not completed any construction, repair, or alteration in the United States.

Next, the commenter took issue with the requirement proposed in § 2.45-15(a)(6)(i) that a classification society must use a system to make its safety records available to the Coast Guard. The commenter believes the provision does not define or sufficiently clarify the scope of information to be provided as part of a vessel's safety records, thereby risking the disclosure of commercially sensitive and confidential information of ship owners to parties who should not be privy to that information.

We appreciate the commenter's concern; however, to determine whether the vessels surveyed by a classification society have an adequate safety record, the classification society would be required to provide all records we formally request. We would request only those records that are necessary to adequately determine the performance of a classification society with respect to safety and, except as required by law, would not disclose those records to any parties with competing interests.

The same commenter stated that § 2.45-15(a)(6)(ii), which requires a classification society to have in place a system to provide its safety records to other classification societies when requested, is redundant because of existing procedures for sharing data. We appreciate the commenter's concern; however, 46 U.S.C. 3316(c)(2)(B)(iii) mandates that the Coast Guard require classification societies to make their safety records available to all relevant parties.

Next, the commenter was concerned with the proposed requirement in § 2.45-15(5) that requires that a country for which a classification society is an RO must be a signatory to the International Convention for the Safety of Life at Sea, 1974, as amended, (SOLAS); the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto (MARPOL); and the International Convention on Load Lines, 1966 (ICLL). The commenter felt that this requirement may cause an adverse situation because a flag state would be compelled to ratify the aforementioned international conventions simply to have its RO meet the Coast Guard's requirement. We disagree that this requirement would create an adverse situation. By ratifying the SOLAS, MARPOL, and ICLL conventions, a flag state would join the majority of flag states that have ratified these conventions and help ensure that their vessels improve their safety record.

Finally, the commenter requested we clarify whether all countries for which a classification society is an RO must be a signatory to each of the SOLAS, MARPOL, and ICLL conventions. The commenter was concerned because classification societies usually are ROs of many countries, including ones that have not ratified some of the international conventions. In response, we point out that the regulatory text in § 2.45-15(a)(4) clearly states that the classification society must have received approval to act as an RO by at least one country that is a signatory to the SOLAS, MARPOL, and ICLL conventions. Therefore, at least one country would have to be a signatory to these conventions.

In this final rule, we made changes to several sections from the proposed rule based on changes in applicability as required by the enactment of the 2010 Act, which amended 46 U.S.C. 3316(c), and to improve clarity and ensure accuracy of the information presented in this final rule.

We amended §§ 2.45-10(a), 2.45-15(a), and 2.45-30 by deleting any references to exemptions for IACS members in accordance with the 2010 Act, which requires all classification societies, without exemption, to seek Coast Guard approval prior to working on a vessel located in the United States.

We amended § 2.45-25 by adding new paragraph (c), which states that an application submitted to become a Coast Guard-RO under 46 CFR part 8, subpart B satisfies the application requirements to become an approved classification society as long as the RO's status has not been revoked, it submits a request to become an approved classification society, and it certifies that the application information submitted under 46 CFR part 8, subpart B remains valid. This change, in response to commenters seeking an exemption or automatic approval based on RO status, avoids requiring organizations to resubmit information they have previously provided as part of an application under 46 CFR part 8, subpart B. This change permits such organizations to submit a minimal application, as long as the Coast Guard has the necessary information evidenced by continuing RO status and the certification that the previously submitted information is still valid.

We amended § 2.45-15(a)(1) to clarify we will review the detention records of a classification society for vessels it surveys during the past 3 years.

We also amended § 2.45-15(a)(5) to clarify that the country for which the classification society is an RO refers to the same country referenced in § 2.45-15(a)(4).

We amended § 2.45-15(a)(5)(ii) by rewording the language of the proposed text to clarify that the one country for which the class society meets the requirement of § 2.45-15(a)(4) cannot be identified as a flag state targeted for additional port state control action by the Coast Guard.

We also made minor changes to the regulatory text. First, the final rule deletes the authority citation for 46 CFR 2.45, as this section was removed from the CFR on September 30, 1997. See 62 FR 51195. Second, the final rule makes minor formatting changes to improve clarity, such as adding paragraph designations within some sections. Finally, throughout the rule we changed the Coast Guard office designator “CG-521” to CG-ENG” to reflect a recent Coast Guard organizational change.

The Director of the Federal Register has approved the material in § 2.45-5 for incorporation by reference under 5 U.S.C. 552 and 1 CFR part 51. Copies of the material are available from the sources listed in that section.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, as amended by Executive Order 13563, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. Accordingly, the Office of Management and Budget (OMB) has not reviewed it under that Order.

As previously discussed in section “V. Discussion of Comments and Changes,” the applicability provision was changed to reflect an amendment to the legal authority made by the Coast Guard Reauthorization Act of 2010. In summary, the total cost for this rule will involve only one-time costs for applications for the initial approval, and we estimate the total will be $5,429. Below, we present the basis for our estimate of the costs for this final rule that accounts for this amendment and the current status of classification societies active in the United States.

We previously approved six classification societies under the policy announced in 2004 based on the 2004 Act. Of the six, these two are IACS members: Indian Register of Shipping and Polish Register of Shipping. The other four that are not IACS members are: Bulgarian Register of Shipping, China Corporation Register of Shipping, Hellenic Register of Shipping, and International Naval Surveys Bureau. In the NPRM, we stated that approved classification societies would not need to take additional actions and would not occur any additional costs. We are not aware of any information, either from the comments or other sources, to alter that assessment. Thus, these six organizations would not have any cost burden associated with this rulemaking.

We identified the remaining members of IACS as the population affected by the 2010 Act amendments, which changed the applicability of 46 U.S.C. 3316(c) to include IACS members in the application and review procedures. Table 2 lists these classification societies and indicates whether they currently have RO status with the Coast Guard under 46 CFR part 8.

As the table shows, there are seven class societies that are not approved but currently have RO status (ABS, BV, DNV, GL, LR, NK, and RINA). We assume that they will take advantage of § 2.45-25(c) and will submit an application to become approved classification societies.

Coast Guard subject matter experts in the Naval Architecture Division provided estimates of time to process one of these applications submitted in accordance with new § 2.45-25(c). The classification society will require 1 hour for a junior manager to draft the application letter and 0.5 hour for a senior manager to review it. Coast Guard processing will require 2 hours for a senior staff member or junior manager to review the application, verify the data, and draft the approval letter, and 0.25 hour for a senior manager to review it. Table 2 presents the complete calculations of the unit cost for this application, with the same wage rates used in the NPRM, “Approval of Classification Societies” (75 FR 21212).

The total cost for these applications is $1,869 and Table 3 displays the calculations.

We anticipate that the other four classification societies that currently are not ROs (CCS, CRS, KRS, and RS) will also apply to become approved classification societies. They will need to prepare a complete application per the requirements of § 2.45-25(b). In the NPRM, we estimated the total unit cost for one of these applications at $890 ($712 for industry and $178 for government). We received no additional information from either the comments or other sources to cause us to modify this estimate. The total cost for these four applications is $3,560, and Table 4 presents the calculations.

In the NPRM, we stated that based on the historical record, we anticipate that the approved classification societies will remain in good standing in the foreseeable future. We received no contrary information since then. With that assumption, we anticipate that there will be no costs associated with suspensions or reapprovals. As stated earlier, we also anticipate that only current IACS members will apply for approval.

With these assumptions, the total costs for this rule will involve only one-time costs for applications for the initial approval, and we estimate the total will be $5,429. Table 5 summarizes these application costs, as previously described.

The benefits of this rule derive from incorporating the amendments from the Coast Guard Authorization Act of 2004 and the Coast Guard Authorization Act of 2010 and incorporating the standards from IMO Resolution A.739(18), “Guidelines for the Authorization of Organizations Acting on Behalf of the Administration,” to provide a sound and internationally recognized standard on which to base our review and approval program.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

For-profit classification societies affected by this rule may be classified under one of the following North American Industry Classification System (NAICS) 6-digit codes for water transportation: 488330—Navigation Services to Shipping or 488390—Other Support Activities for Water Transportation. According to the Small Business Administration's (SBA) size standards, a U.S. company classified under these NAICS codes with annual revenues of less than $7 million is considered a small entity.

The only predominant U.S. classification society is the American Bureau of Shipping (ABS), which is a non-profit organization. We do not consider the ABS to be a small entity under the Regulatory Flexibility Act. In addition, the costs that we described in the previous section are so minimal, we do not believe they rise to the level of being a significant economic impact. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520).

This rule comprises application procedures classification societies must meet for approval. As stated in Section VII.A, we expect four new approvals in the first year after the rule becomes effective. In the NPRM, we forecasted that there would be no or very few applications in the near future. We received no comments or additional information to indicate that there would be 10 or more approvals after the first year. Thus, we expect to receive less than 10 approval requests per year. This figure is less than the threshold of 10 per 12-month period for collection of information reporting purposes under the PRA.

This rule specifies a separate approval process for classification societies that are currently ROs. These ROs will only need to send the Coast Guard a letter requesting that we use previously collected data as the basis for their approval.

As stated in Section VII.A, we expect the seven current ROs to use this method to apply for approval the first year the rule becomes effective. This process does not require any new information and the affected population is less than the threshold of 10 per 12-month period for collection of information reporting purposes under the PRA.

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Although this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule uses the following voluntary consensus standards: IMO Resolution A.739(18), “Guidelines for the Authorization of Organizations Acting on Behalf of the Administration.” The section that references this standard and the location where this standard is available is listed in 46 CFR 2.45-5.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded under section 2.B.2, figure 2-1, paragraphs (34)(b) and (d) of the Instruction. This rule involves regulations concerning internal agency functions and regulations concerning manning, documentation, admeasurement, inspection, and equipping of vessels. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 46 CFR part 2 as follows:

In August 2006, NHTSA issued a final rule  1 amending 49 CFR part 563 (Part 563) to establish uniform performance requirements for the accuracy, collection, storage, survivability, and retrievability of onboard motor vehicle crash EDRs voluntarily installed in light passenger vehicles. Specifically, the regulation applies to passenger cars, multipurpose passenger vehicles, trucks, and buses with a gross vehicle weight rating (GVWR) of 3,855 kg (8,500 pounds) or less and an unloaded vehicle weight of 2,495 kg (5,500 pounds) or less, 2 that are voluntarily equipped with an EDR. The 2006 final rule aimed to standardize the data obtained through EDRs so that such data would provide information to enhance the agency's understanding of crash events and safety system performance, thereby potentially contributing to safer vehicle designs and more effective safety regulations. The 2006 final rule was intended to be technology-neutral, so as to permit compliance with any available EDR technology that meets the specified performance requirements.

On January 14, 2008, 3 the agency responded to petitions for reconsideration on the August 2006 final rule, and made the following amendments to Part 563:

• Clarified the event storage definitions to alleviate any uncertainties in multiple event crashes;

• Revised certain sensor ranges and accuracies to reflect current state of the art technologies;

• Clarified the recorded data reporting format;

• Specified vehicle storage conditions during compliance testing;

• Clarified the required data elements and scope of covered sensors; and

• Revised the effective date to provide sufficient time for manufacturers and suppliers to comply with the rule.

On August 5, 2011, 5 the agency published a final rule responding to three petitions for reconsideration and made the following clarifications and amendments to Part 563:

• Removed the required standardization of the reporting requirements for all acceleration data requirements to address certification issues with data clipping, filtering and phase-shifting;

• Clarified the application of sensor tolerances to within the range of the applicable sensor;

• Clarified our position regarding exclusion of peripheral sensors from the reporting requirements for EDRs;

• Clarified the event storage definition to alleviate uncertainties in multiple event crashes;

• Revised requirements for the capture of event data in crashes that:

○ Involve side or side curtain/tube air bags such that EDR data would only need to be locked if the vehicle also captures lateral delta-V data, and

○ Involve non-reversible deployable restraints other than frontal, side or side/curtain tube air bags such that EDR data would not need to be locked at the option of the manufacturer,

• Clarified that any non-reversible deployable restraint may serve as an event trigger;

• Revised the minimum range requirement for the “Steering input” data element from an angular basis to a percentage basis; and

• Made other minor technical and editorial corrections.

In response to the 2011 final rule, the agency received three petitions for reconsideration  6 from the Alliance of Automobile Manufacturers (Alliance), the Automotive Safety Council  7 (ASC), and Honda Motor Co., LTD (Honda). The Association of Global Automakers, Inc. Technical Affairs Committee (GAM), and Nissan North America, Inc. (Nissan) both submitted comments in support of the petitioners' requests. After careful consideration, the agency is granting some aspects of the petitions, and denying others. This document amends the final rule accordingly.

Based on a petition for reconsideration from Bosch, the 2011 final rule modified the format and range of the steering input data element in Table III from a range of -250 degrees clockwise (CW) to 250 degrees counterclockwise (CCW) with a resolution specification of 1 percent to a percentage of the lock-to-lock steering wheel angle of ± 100 percent with a 1 percent range. The Alliance and Honda petitioned the agency to revert the range specification to the original range of -250 degrees clockwise (CW) to 250 degrees counterclockwise (CCW) with a resolution specification of 5 degrees. In its petition the Alliance stated that steering wheel angle sensors report the actual steering wheel angle in degrees. In order for the EDR to report the steering input in percent, the EDR module would need to have information about the vehicle's total lock-to-lock steering wheel angle capability. However, the total lock-to-lock steering wheel angle may vary not only from one vehicle model to another, but also within a vehicle trim line.

The Alliance added that the same vehicle trim line with a different suspension package or gear box also might have a different total lock-to-lock angle and each vehicle line would need to be specifically calibrated in order for the EDR to report steering input as a percentage based on that vehicle's steering wheel rotation capability. The Alliance went on to state that implementing the new EDR requirement to report steering input in percent would impose an unnecessary complex proliferation of EDR calibrations to match vehicle builds.

Honda noted that in addition to the variability both between and within vehicle trim lines, steering angle sensors simply detect and display the actual rotation angle of the steering wheel and do not detect if the steering wheel is in the locked position. Honda stated that it could not report steering input as a percentage value without drastic changes to vehicle steering system design and incorporation of new steering angle sensors. Both Nissan and GAM submitted comments in support of the Alliance and Honda petitions to reinstate the original input range to −250 degrees CW to 250 degrees CCW with a resolution specification of 5 degrees.

Bosch has submitted a letter in support of the Honda and Alliance petitions for reconsideration expressing its agreement with the petitioners' arguments. 8 In its letter and in an ex-parte meeting with the agency, Bosch reiterated the other petitioners' concerns that the data element change may require additional calibration and software changes. It noted that the majority of electronic stability control (ESC) systems utilize steering input information in degrees, not percentages. It stated that manufacturers may not have enough time to implement this change, and as a result may have to remove the steering wheel angle data from the EDR log.

SAE International (SAE) submitted to the 2011 final rule docket what they described as a technical amendment to the steering input parameter. Its submission supports a return to the reporting of a ± 250 degrees steering wheel angle. However, it indicated that the sign convention for the direction of rotation should be reversed such that it should be reported as 250 degrees CW to −250 degrees CCW. It indicated that a CW positive sign is consistent with a Z axis down (into the steering wheel) philosophy explained in SAE Recommended Practice J670, “Vehicle Dynamics Terminology,” and well as the philosophy being used to update the EDR parameter definitions in SAE Recommended Practice J1698-1, “Event Data Recorder—Output Data Definition.”

Finally, SAE additionally requested that the accuracy of this data element be modified from ± 5 percent to the larger of ± 5 degrees or ± 5 percent of the reading. SAE stated that this change would add clarity to the accuracy specification while assuring that it is not too small for small steering angles.

All three petitioners requested that the agency consider delaying the requirement that an EDR must flag the first occurrence of input that saturates or clips the sensor. The Alliance and Honda agreed with the agency's intention to record the timing of when the design range of a sensor is exceeded. However, each petitioner commented that it would be too difficult to complete the necessary system programming within the 12-month interval between the August 5, 2011 final rule and the September 1, 2012 effective date of Part 563. Honda requested the agency delay this requirement for 1 year, while the Alliance and GAM requested a 2-year delay.

Honda stated that given the extensive ramifications of a software modification, they investigated the feasibility of detecting the time of a data clipping occurrence through the data retrieval tool. They stated that the result of this investigation indicated that it is not feasible to accurately capture the time of data clipping due to the low frequency in which the EDR records the data that is available for imaging by the tool (100 Hz).

The Alliance commented that the revisions to the “End of event time” definition to be based on the resultant vehicle delta-V will affect both the data reporting requirements and the capture and storage requirements for EDRs. The ASC noted that this change could require a real-time calculation to determine when the resultant has been met under all conditions. Both the Alliance and the ASC noted that this may result in changes to the EDR software and require evaluation prior to implementation. Honda noted that certain strategies would determine the end of event when both the lateral and the longitudinal delta-V fall below the 0.8 km/h (0.5 mph) limit. In this case, the end of event determined by the EDR algorithm may be marginally earlier than specified in Part 563. The Alliance and Honda proposed that the agency consider revising the end of event definition as follows:

The GAM supported both the Alliance and Honda petitions to make this change to the end of event time definition.

Both the Alliance and Honda requested clarification on the revisions to the occupant size classifications definition. They stated that the current definition is misleading in that it may now include the 5th percentile female (as defined in 49 CFR part 572, subpart O) in the same category as an adult, particularly in the driver's designated seating position. The GAM supported the Alliance and Honda petitions. The petitioners requested that the agency clarify if, in fact, it intended to include 5th percentile females in the larger occupant category.

The Alliance and ASC petitioned the agency to clarify the requirements for data capture by EDRs in events utilizing non-reversible deployable restraints other than air bags. They stated their belief that the agency intended to allow capture and recording of deployments of devices such as pretensioners at the option of the manufacturer, but that the current regulatory text in 49 CFR 563.9(b) does not specify this optional nature. The ASC asked for clarification on whether or not such non-reversible restraint deployments would be required to be locked. The GAM supported the Alliance petition, and recommended that the agency adopt the Alliance proposal to codify the optional nature of non-air bag, non-reversible restraint deployments.

The ASC requested clarification on the locking of events involving side impact air bags. It commented that the regulatory text  9 could be interpreted to mean that if a side impact deployment occurs first, it would be locked and a subsequent secondary frontal air bag deployment would not be recorded. It further suggested that this would not be in keeping with the agency's intent to record frontal air bag deployments. The GAM supported the ASC request for clarification.

Honda and GAM requested that the agency consider holding a technical workshop to ensure that all stakeholders are properly prepared to comply with Part 563 given the myriad complex issues and iterations of the regulation. GAM added that such an exchange would aid in resolving any additional technical issues in the most expeditious manner possible.

Honda, ASC, and GAM urged the agency to publish a compliance test procedure for Part 563 as soon as possible. Without a test procedure, they noted that it will be very difficult to maintain consistent and reliable compliance across the industry. The ASC added that NHTSA should harmonize the test procedure for Part 563 with the appropriate test procedures for the Society of Automotive Engineers (SAE) recommended practices.

Steering input with respect to Part 563 is an optional data element used to determine the driver's intent prior to a crash. In its petition for reconsideration of the 2008 final rule, Bosch commented that the Table III accuracy and resolution requirements for the steering input data element are inconsistent with other data elements. It recommended that the agency revise the range definition for this data element to ± 100 percent. In response, the agency revised the minimum range requirement for the “Steering input” data element from −250 degrees CW to 250 degrees CCW to a value of ± 100 percent in Table III in the 2011 final rule. We stated we agreed with Bosch that this change would be more consistent with the accuracy and resolution requirements being expressed as percentages. We also believed the change would better address state-of-the-art active steering systems where the steering wheel angle and tire position may not correlate.

In consideration of the Alliance and Honda petitions for reconsideration of the 2011 final rule on the issue of steering input and the supporting information subsequently provided by Bosch, we are now reverting back to the steering input data element range of −250 degrees CW to 250 degrees CCW that was in the 2008 final rule. The change to the range made in the 2011 final rule was not intended to add unnecessary complexity to the vehicle's EDR. At the time of our earlier decision, we agreed with the need for desired consistency with other data elements (such as throttle and accelerator pedal position) and Bosch's petition for this change did not speak to the vehicle trim line implications and the complexities that would result.

We are not making this change in response to comments suggesting that the rule would require drastic changes in steering design. We believe that the reporting of angle as a percentage of full lock to the tolerance required could be implemented by a software change in the download tool and knowledge of the full lock angle for the vehicle make/model.

At the time of our analysis for the 2011 final rule, the majority of EDR data collected did not include steering input in the vehicle pre-crash data set. As a result, the agency had little practical experience with manufacturer plans for use of the voluntary steering input data element. However, after reviewing more recent EDR crash data where the pre-crash steering input was captured, we believe the original steering input range measured in degrees may be a more practical indicator. While the same information could be obtained from a percentage value, this would require knowledge of the number of degrees to fully lock in each direction. Rather, we believe it would be more convenient to crash investigators to have the degree information without having to seek out the additional information about the full lock angle from the vehicle manufacturer or other means. If an investigator wishes to know the angle as percentage of full lock, they can take the extra step to get the full lock angle and do the conversion.

We note that no change was made based upon SAE's comments. We have considered their comments and suggested “technical amendments.” However, we do not believe the changes suggested by SAE could be considered technical amendments. In addition, the submission was received outside of the 45-day period for filing a petition for reconsideration. As such, we will treat it as a petition for rulemaking and will consider it under our plans for publishing an advance notice of proposed rulemaking in the near future to explore the potential for, and future utility of, capturing additional EDR data in light vehicles.

We agree with Honda, the Alliance, ASC, and GAM that the data clipping flag requirement should be delayed by one year.

In the 2011 final rule, the agency addressed the issue of data clipping that may occur during extreme crash events, or even for brief periods of time during crash testing, by revising footnote 1 of Table III to require manufacturers to report when sensors first exceed their design range. The 2011 final rule, however, left the manner by which the clipping is indicated up to the vehicle manufacturer and did not limit the potential methods for achieving this requirement. Instead, we provided the examples of a flag on the data trace, or an additional reported field indicating the timing of the clipping.

The Alliance, ASC, and GAM both asserted that, although they were supportive of the data clipping flag requirement, that modifications, including new software, will be necessary in order to meet this requirement. The Alliance and GAM stated that an additional year is necessary to make these modifications. ASC requested that the data clipping requirement be delayed or eliminated until it can be properly studied. Honda indicated that the data retrieval tool cannot simply be reprogrammed to detect data clipping and report it. It further explained that the restraint control systems developed to properly operate the occupant restraint systems were not designed to capture the time at which the sensor inputs exceed their design range. It also stated that it is not feasible to accurately capture the saturation timing via a data retrieval tool because of the low sampling rate of the EDR.

We agree with Honda, the Alliance, ASC, and GAM that modifications may be necessary to existing EDRs in order to meet the data clipping flag. In particular, Honda provided a reasoned explanation of the software modifications that would be necessary to comply with the data clipping flag requirement and why an additional year is necessary. Although we believe that it may be feasible to use the data retrieval tool to detect data clipping to a level of accuracy that would allow manufacturers to report delta-V with the required accuracy, we understand that the use of the data retrieval tool to flag the clipping may provide some short-term technical challenges. Therefore, we are providing one extra year of lead time for this particular requirement to give manufacturers additional flexibility.

We are denying the Alliance, ASC, and Honda petitions to reconsider amendments to the definition for an end of event. The petitioners state that the addition of “resultant” to the definition may marginally affect the determination of the end of an event. The Alliance and GAM noted that not all EDRs capture lateral delta-V and that those vehicles that do capture lateral delta-V may not currently calculate the resultant. They stated that calculating the resultant delta-V could necessitate additional software changes, delaying the ability of the manufacturers to comply with Part 563.

The agency agrees that not all EDRs capture lateral delta-V. However, we note that in these cases, the resultant delta-V would simply be the longitudinal delta-V. For all other cases, we believe there is sufficient latitude in the definition for end of event for vehicle manufactures to institute an EDR strategy that meets the definition without undue burden. We note that manufacturers ultimately determine how the crash detection algorithm resets. Therefore, in cases where both lateral and longitudinal delta-V data are collected, manufacturers may opt to determine when the end of the event has occurred via the resultant cumulative delta-V, or via any method by which they choose to reset the crash detection algorithm. In the worst case, the vehicle will need to capture the full 300 ms of delta-V data, which has been required by Part 563 since the 2006 final rule.

We are denying the Honda and Alliance petitions to reconsider the occupant size classifications. Since the proposed rulemaking  10 stage of Part 563, the agency has intended for the occupant size classification to be inclusive of the 5th percentile female as defined in 49 CFR part 572, subpart O. The revisions enacted in the 2011 final rule were simple clarifications to the original agency intent. We do not believe that there is a conflict with the resolution for this data element in Table III. Therefore, this data element will be used to report if the occupant in a designated seating position would meet the criteria of the 5th percentile female or larger.

We are denying the Alliance and ASC petitions to clarify how the deployment of non-reversible restraints other than air bags are recorded. We believe that section 563.9(b) is clear that when a memory buffer is available, EDRs must capture and record current event data that does not involve deployment of an air bag. If the memory buffers are full, manufacturers may either overwrite any previous data that does not involve deployment of an air bag, or not record the current event data if it does not involve deployment of an air bag. In this manner, manufacturers may prioritize the capture of events that do not involve deployments of air bags, but do deploy other non-reversible restraints regardless of type.

In response to the ASC request for clarification on the locking of events involving side impact air bags, we agree that if a side impact deployment occurs first and the EDR records lateral delta-V, this event would need to be locked; however, a subsequent event (including the deployment of a frontal air bag) would not need to be recorded, but it could be allowed at the option of the manufacturer. We refer to the preambles of the previous rulemakings on the subject. Specifically, we stated the following in the preamble to the 2011 final rule. 11

In response to the Honda and GAM request that the agency consider holding a technical workshop to ensure that all stakeholders are properly prepared to comply with Part 563, we do not believe that a technical workshop is needed at this time. We remain open to this possibility if the need presents itself in the future.

The agency is working with the SAE EDR committee to ensure that any compliance test procedure we produce would consider the SAE J1698 Vehicle Event Data Interface recommended industry practices, as appropriate. The test procedure and accompanying documents will be provided in the docket  12 for the 2011 final rule.

We have considered the impact of this rulemaking action under Executive Order 12866, “Regulatory Planning and Review,” Executive Order 13563, “Improving Regulation and Regulatory Review,” and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed by the Office of Management and Budget under those two Executive Orders. It has been determined not to be “nonsignificant” under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures. This rule makes several technical changes to the regulatory text of 49 CFR part 563, and does not increase the regulatory burden of manufacturers. A complete statement of the costs and benefits of the introduction of Part 563 are available in the August 2006 final rule and the accompanying Final Regulatory Evaluation. 13

The agency has discussed the relevant requirements of the Vehicle Safety Act, the Regulatory Flexibility Act, Executive Order 13132 (Federalism), Executive Order 12988 (Civil Justice Reform), Executive Order 13045 (Protection of Children from Health and Safety Risks), the Paperwork Reduction Act, the National Technology Transfer and Advancement Act, Unfunded Mandates Reform Act, and the National Environmental Policy Act in the August 2006 final rule cited above. Those discussions are not affected by these technical changes.

Please note that anyone is able to search the electronic form of all documents received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78), or you may visit http://www.dot.gov/privacy.html.

In consideration of the foregoing, 49 CFR part 563 is amended as follows: