Viral hemorrhagic septicemia (VHS) is a highly contagious disease of certain fresh and saltwater fish, caused by a rhabdovirus. It is listed as a notifiable disease by the World Organization for Animal Health. The pathogen produces variable clinical signs in fish including lethargy, skin darkening, exophthalmia, pale gills, a distended abdomen, and external and internal hemorrhaging. The development of the disease in infected fish can result in substantial mortality. Other infected fish may not show any clinical signs or die, but may be lifelong carriers and shed the virus.

The Animal Health Protection Act (AHPA, 7 U.S.C. 8301-8317) authorizes the Secretary of Agriculture to prohibit or restrict the importation or movement in interstate commerce of any animal, article, or means of conveyance if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or dissemination of any pest or disease of livestock into or within the United States.

In response to outbreaks of VHS in wild fish populations in the Great Lakes, the Administrator determined that it was necessary, in order to prevent the spread of VHS into aquaculture facilities, to prohibit or restrict the interstate movement and importation of VHS-regulated species of live fish. Accordingly, on October 24, 2006, the Animal and Plant Health Inspection Service (APHIS) issued a Federal Order prohibiting the importation of VHS-susceptible species of live fish from two Canadian provinces (Ontario and Quebec) into the United States and the interstate movement of the same species of live fish from the eight States bordering the Great Lakes (Illinois, Indiana, Michigan, Minnesota, New York, Ohio, Pennsylvania, and Wisconsin). Subsequent modifications to the Federal Order were made in response to additional information provided by States, Tribes, and other interested stakeholders in order to alleviate impacts on industry and related businesses in the Great Lakes region while still protecting against the spread of VHS. The Federal Order was meant to be a temporary measure to be replaced in time by a rule.

Taking into consideration the information we received, on September 9, 2008, we published an interim rule  1 in the Federal Register (73 FR 52173-52189, Docket No. APHIS-2007-0038) to codify the Federal Order by amending 9 CFR parts 71, 83, and 93 to establish regulations to restrict the interstate movement and the importation into the United States of certain live fish species that are susceptible to VHS. We announced that the provisions of the interim rule would become effective November 10, 2008, and that we would consider all comments on the interim rule received on or before November 10, 2008, and all comments on the environmental assessment for the interim rule received on or before October 9, 2008.

After the publication of the interim rule, we received comments that addressed a variety of issues, including the feasibility of implementing certain requirements.

Based on our review of those comments, on October 28, 2008, we published a document in the Federal Register (73 FR 63867, Docket No. APHIS-2007-0038) announcing that we were delaying the effective date of the interim rule from November 10, 2008, until January 9, 2009, while retaining November 10, 2008, as the close of the comment period for the interim rule and October 9, 2008, as the close of the comment period for the environmental assessment.

On January 2, 2009, we published a document in the Federal Register (74 FR 1, Docket No. APHIS-2007-0038) announcing that we were delaying the effective date of the interim rule indefinitely to provide APHIS with time to make adjustments to the interim rule that we considered necessary for the rule to be successfully implemented.

After completing a risk assessment of the disease and evaluating surveillance and the latest science, we determined that the Federal Order, which had become duplicative with State regulations, could safely be removed as long as States maintain existing VHS regulations and other practices to reduce risk. Therefore, on April 14, 2014, APHIS announced that the VHS Federal Order first issued in October 2006 would be rescinded on June 2, 2014.

Accordingly, we are also withdrawing the September 9, 2008, interim rule. APHIS will continue to work with our stakeholders to provide guidance and promote sound biosecurity practices to prevent the spread of VHS and other aquatic animal diseases of concern.

Background

The United States maintains a comprehensive embargo on trade with Cuba. Pursuant to that embargo, all items that are subject to the Export Administration Regulations (EAR) require a license for export or reexport to Cuba unless authorized by a license exception. The Bureau of Industry and Security (BIS) administers export and reexport restrictions on Cuba consistent with the goals of that embargo and with relevant law. Accordingly, BIS may issue specific or general authorizations for specific types of transactions that support the goals of United States policy while the embargo remains in effect.

On December 17, 2014, the President announced that the United States is taking historic steps to chart a new course in bilateral relations with Cuba and to further engage and empower the Cuban people. The President explained that these steps build upon actions taken since 2009 that have been aimed at supporting the ability of the Cuban people to gain greater control over their own lives and determine their country's future. Today, the Commerce and Treasury Departments are taking coordinated actions to implement this policy.

The President's announcement necessitates changes to the EAR related to exports and reexports to promote more effectively positive change in Cuba, consistent with U.S. support for the Cuban people and in line with U.S. national security interests. This rule implements those changes by adding license exceptions and revising licensing policy as appropriate.

This rule enables the export and reexport to Cuba of items intended to empower the nascent Cuban private sector by supporting private economic activity. Items include building materials for use by the private sector to construct or renovate privately-owned buildings including privately-owned residences, businesses, places of worship and buildings for private sector social or recreational use; goods for use by private sector entrepreneurs such as auto mechanics, barbers and hairstylists and restaurateurs; and tools and equipment for private sector agricultural activity. It is intended to facilitate Cuban citizens' lower-priced access to certain goods to improve their living standards and gain greater economic independence from the state. It also enables the export and reexport to Cuba of items to further support civil society in Cuba.

Additionally, this rule enables the export to Cuba of certain items intended to contribute to the ability of the Cuban people to communicate with one another and with people in the United States and the rest of the world. Those exports include commercial sales of items for the establishment and upgrade of communications-related systems as well as certain consumer communications devices, related software, applications, and hardware. Such exports are consistent with Department of Commerce authorities including with Section 1705(e) of the Cuban Democracy Act (22 U.S.C. 6004(e)), which authorizes export of “[t]elecommunications facilities . . . in such quantity and of such quality as may be necessary to provide efficient and adequate telecommunications services between the United States and Cuba.”

This rule also enables more donations to the Cuban people by simplifying the process to export and reexport gift parcels to Cuba. Lastly, this rule establishes licensing policy relating to environmental protection and makes technical and conforming changes to the EAR.

The Department of the Treasury's Office of Foreign Assets Control (OFAC) is also making changes to its regulations to implement the President's December 17, 2014, policy announcement.

This rule creates a new § 740.21 of the EAR—License Exception Support for the Cuban People (SCP). Prior to publication of this rule, the export or reexport to Cuba of items now eligible under this new license exception generally required a license from BIS.

To support improved living conditions and support independent economic activity in Cuba, License Exception SCP authorizes the export and reexport of commercially sold or donated:

• Building materials, equipment, and tools for use by the private sector to construct or renovate privately-owned buildings, including privately-owned residences, businesses, places of worship and buildings for private sector social or recreational use;

• Tools and equipment for private sector agricultural activity; and

• Tools, equipment, supplies, and instruments for use by private sector entrepreneurs. Note that this provision will, for example, allow the export of such items to private sector entrepreneurs, such as auto mechanics, barbers and hairstylists and restaurateurs.

Items eligible for export and reexport to Cuba pursuant to this portion of License Exception SCP are limited to those designated as EAR99 ( i.e., items subject to the EAR but not specified in any Export Control Classification Number (ECCN)) or controlled on the Commerce Control List (CCL) only for anti-terrorism reasons.

To strengthen civil society in Cuba, License Exception SCP authorizes the export and reexport to Cuba of certain donated items for use in scientific, archaeological, cultural, ecological, educational, historic preservation, or sporting activities. The activities may not relate to the development, production, use, operation, installation, maintenance, repair, overhaul or refurbishing of any item enumerated or otherwise described on the United States Munitions List (22 CFR part 121) or on the Commerce Control List (Supplement No. 1 to part 774 of the EAR) unless the only reason for control that applies to that item as set forth in the ECCN that controls that item is anti-terrorism.

Additionally, License Exception SCP authorizes the temporary export of certain items by persons departing the United States for their use in scientific, archeological, cultural, ecological, educational, historic preservation, or sporting activities or for their use in their professional research. The activities or research may not relate to the development, production, use, operation, installation, maintenance, repair, overhaul or refurbishing of any item enumerated or otherwise described on the United States Munitions List (22 CFR part 121) or on the Commerce Control List (Supplement No. 1 to part 774 of the EAR) unless the only reason for control that applies to that item as set forth in the ECCN that controls that item is anti-terrorism. The research must be directly related to the traveler's profession, professional background or area of expertise, including area of graduate-level full-time study. Items authorized for temporary export must be returned to the United States within two years unless consumed in Cuba, or the exporter has applied for and obtained, prior to the expiration of the two year period, a license from BIS authorizing the items to remain in Cuba longer than two years.

License Exception SCP also authorizes the export and reexport to Cuba of certain items to human rights organizations, individuals, or non-governmental organizations that promote independent activity intended to strengthen civil society. Items eligible for the civil society portion of License Exception SCP are limited to those designated as EAR99 or items on the CCL for which the only reason for control is anti-terrorism.

To improve the free flow of information to, from, and among the Cuban people, License Exception SCP authorizes the export and reexport to Cuba of certain items for telecommunications, including access to the Internet, use of Internet services, infrastructure creation and upgrades. Lastly, License Exception SCP authorizes the export and reexport to Cuba of certain items for use by news media personnel and U.S. news bureaus engaged in the gathering and dissemination of news to the general public. Items eligible for export and reexport to Cuba pursuant to this portion of the license exception SCP are limited to those designated as EAR99 or controlled on the CCL only for anti-terrorism reasons.

This rule revises License Exception Consumer Communications Devices (CCD) in § 740.19 of the EAR to remove the donation requirement and update the list of eligible items. License Exception CCD was created in 2009 at the direction of the President to help enhance the free flow of information to and from Cuba (74 FR 45985, September 8, 2009). This license exception authorizes export and reexport of consumer communications devices (commodities such as computers, communications equipment and related items, including personal computers, mobile phones, televisions, radios and digital cameras) that are widely available for retail purchase and that are commonly used to exchange information and facilitate interpersonal communications, as well as certain telecommunications and information security-related software. Prior to publication of this rule, License Exception CCD authorized the export or reexport only of donated items, which limited the incentive to send these items to Cuba. This rule removes the donation requirement in License Exception CCD, thereby allowing export or reexport of eligible items for commercial sale or donation to eligible recipients in Cuba.

This rule makes several minor technical revisions to some of those paragraphs in order to track more precisely current technical specifications for certain items and to state explicitly that some items must be consumer items to be eligible for this license exception.

This rule revises the references to ECCN 5A992 in CCD paragraphs (b)(5)—monitors, (b)(6)—printers, (b)(7)—modems, (b)(10)—mobile phones and related items, (b)(11)—memory devices, and (b)(12)—information security, to read ECCN 5A992.c. Paragraph .c refers to “commodities” regarding which “BIS has received an encryption registration or that have been classified as mass market encryption commodities in accordance with § 742.15(b) of the EAR.” The inclusion of this paragraph more precisely describes the devices listed in those CCD paragraphs that are eligible for this license exception.

This rule adds a reference to ECCN 5A992.c to paragraph (b)(1) because most modern personal computers generally would be classified under that ECCN due to their encryption capability. This rule also removes the reference to 0.02 weighted teraflops from paragraph (b)(1) because virtually all personal computers manufactured currently have a higher adjusted peak performance level than 0.02 weighted teraflops.

This rule adds a reference to ECCN 5A991.b.4 to paragraph (b)(7) because certain modems that are widely used in consumer communications ( e.g., DSL and ADSL modems) would be classified under ECCN 5A991.b.4.

This rule revises the reference to ECCN 5D992 to read 5D992.c in CCD paragraphs (b)(12)—information security and (b)(17)—software for items in paragraphs (b)(1) through (b)(16). The inclusion of paragraph .c, which covers “`[s]oftware'” for which “BIS has received an encryption registration or that have been classified as mass market encryption software in accordance with § 742.15(b) of the EAR,” more precisely describes the mass market devices listed in those CCD paragraphs that are eligible for this license exception.

The other provisions of the license exception remain unchanged.

This rule revises License Exception Gift Parcels and Humanitarian Donations (GFT) in § 740.12 of the EAR to remove the note that excludes from eligibility consolidated shipments of multiple parcels for delivery to individuals residing in a foreign country. Due to this note, parties exporting multiple gift parcels in a single shipment have been required to obtain individual validated licenses. Although the requirement is not limited to Cuba, in recent years BIS has received gift parcel consolidation license applications only for Cuba, which are routinely approved. Individuals who wish to send gift parcels to Cuba have had to search for parties that have received consolidation licenses, resulting in an unintended disincentive to donate eligible items to the Cuban people. Removing the note allows export and reexport of multiple gift parcels in a single shipment pursuant to License Exception GFT. All the other terms and conditions of the license exception remain unchanged.

This rule amends the licensing policy for Cuba in § 746.2 of the EAR to add a general policy of approval for exports and reexports of items necessary for the environmental protection of U.S. and international air quality, waters, and coastlines (including items related to renewable energy or energy efficiency). Because environmental threats are not limited by national borders, circumstances may warrant the export and reexport of certain items to Cuba to protect U.S. national interests or international interests. Although the existing Cuba licensing policy in the EAR includes the flexibility to authorize environmental protection-related transactions, this revision notifies the public of the U.S. policy interest in considering applications for such authorizations.

This rule removes from the EAR General Order No. 4 in Supplement No. 1 to Part 736, § 748.8(d), and paragraph (d) of Supplement No. 2 to Part 748. Those three provisions addressed aspects of licenses or license applications for consolidated shipments of gift parcels that individually were eligible for License Exception GFT. Because this rule makes the consolidated shipments eligible for the same license exception that applies to the individual gift parcels, the consolidated shipment licenses and the information in General Order No. 4, § 748.8(d) and Supplement No. 2 to Part 748 paragraph (d) are no longer needed.

Section 746.2(b) addresses licensing policy for Cuba. This rule revises text in § 746.2(b)(2) and (b)(4) to account for transactions that are now eligible for new License Exception SCP.

This rule adds new License Exception SCP to the list of available License Exceptions for Cuba in § 746.2 of the EAR.

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 7, 2014, 79 FR 46959 (August 11, 2014), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB).

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) control number. This rule involves a collection of information approved under OMB control number 0694-0088—Simplified Network Application Processing+ System (SNAP+) and the Multipurpose Export License Application, which carries an annual estimated burden of 31,833 hours. BIS believes that this rule will have no material impact on that burden. To the extent that it has any impact, this rule could impact the burden in two ways. First, this rule might reduce the burden because it makes some transactions that would otherwise require a license eligible for a license exception. Second, although this rule does not impose any new license requirements, it creates less restrictive licensing policies ( i.e., the policies under which the decision to approve or deny a license application is made) for exports and reexports for environmental protection. These less restrictive policies might increase the number of license applications submitted to BIS because applicants might be more optimistic about obtaining approval. BIS believes that reduction in the number of license applications resulting from increased license exception availability is likely to more than offset any increase in the number of license applications resulting from less restrictive licensing policy because the former involves a large number of small transactions whereas the less restrictive license policy impacts a smaller number of larger value transactions. Moreover, the benefit to license applicants in the form of greater likelihood of approval justifies any additional burden.

Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget, by email at jseehra@omb.eop.gov or by fax to (202) 395-7285 and to William Arvin at william.arvin@bis.doc.gov.

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

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States ( See 5 U.S.C. 553(a)(1)). This rule is a part of a foreign policy initiative to change the nature of the relationship between Cuba and the United States announced by the President on December 17, 2014. Delay in implementing of this rule to obtain public comment would undermine the foreign policy objectives that the rule is intended to implement. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under 5 U.S.C. 553, or by any other law, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable.

For the reasons set forth in the preamble, 15 CFR Chapter VII, Subchapter C is amended as follows:

Electronic and Facsimile Availability

This document and additional information concerning OFAC are available from OFAC's Web site ( www.treasury.gov/ofac ). Certain general information pertaining to OFAC's sanctions programs also is available via facsimile through a 24-hour fax-on-demand service, tel.: 202/622-0077.

The Department of the Treasury issued the Cuban Assets Control Regulations, 31 CFR part 515 (the “Regulations”), on July 8, 1963, under the Trading With the Enemy Act (50 U.S.C. App. 5 et seq. ). OFAC has amended the Regulations on numerous occasions. Notably, on September 3, 2009, OFAC amended the Regulations to implement measures announced by the President on April 13, 2009 to promote democracy and human rights in Cuba by easing travel restrictions to facilitate greater contact between separated family members in the United States and Cuba and by increasing the flow of remittances and information to the Cuban people. On January 28, 2011, OFAC further amended the Regulations to implement certain policy changes announced by the President on January 14, 2011 designed to increase people-to-people contact, support civil society in Cuba, enhance the free flow of information to, from, and among the Cuban people, and help promote their independence from Cuban authorities. These amendments allowed for greater licensing of travel to Cuba for educational, cultural, religious, and journalistic activities and expanded licensing of remittances to Cuba. These amendments also modified regulations regarding authorization of transactions with Cuban nationals who have taken up permanent residence outside of Cuba and implemented certain technical and conforming changes.

OFAC is now amending the Regulations to implement certain policy changes announced by the President on December 17, 2014 to further engage and empower the Cuban people. These amendments facilitate travel to Cuba for authorized purposes, facilitate the provision by travel agents and airlines of authorized travel services and the forwarding by certain entities of authorized remittances, raise the limit on remittances to Cuba, allow U.S. financial institutions to open correspondent accounts at Cuban financial institutions to facilitate the processing of authorized transactions, authorize certain transactions with Cuban nationals outside of Cuba, and allow a number of other activities related to, among other areas, telecommunications, financial services, trade, and shipping. These amendments also implement certain technical and conforming changes.

Travel to Cuba for authorized purposes. OFAC is amending sections 515.533, 515.545, 515.560 through 515.567, and 515.574 through 515.576 to authorize travel-related transactions and other transactions incident to activities within the 12 existing travel categories in OFAC's regulations—such as for educational activities (including people-to-people travel), journalistic and religious activities, professional meetings, and humanitarian projects—without the need for case-by-case specific licensing, while continuing not to authorize travel for tourist activities, which is prohibited by statute. The authorizations contain certain restrictions appropriate to each category of activities.

Travel services. OFAC is amending section 515.572 to permit persons subject to U.S. jurisdiction, including travel agents and airlines, to provide authorized travel and carrier services, and certain entities to forward authorized remittances, under conditions set forth below, without the need for specific licenses from OFAC.

Remittances. OFAC is amending section 515.570 to raise from $500 to $2,000 per quarter the limits on remittances that may be sent to Cuban nationals, and to generally authorize, as is done now, as appropriate, on a case-by-case basis, without limitation, remittances for humanitarian projects, support for the Cuban people, and development of private business in Cuba. Section 515.560(c) is amended to raise to $10,000 the total amount of remittances that a traveler may carry to Cuba.

Credit and debit cards, per diem, and importation of certain goods and services. OFAC is amending section 515.560 and adding a new section 515.584 to authorize the use of U.S. credit and debit cards in Cuba for travel-related and other transactions consistent with section 515.560 and to allow U.S. financial institutions to enroll merchants and to process such transactions. OFAC also is amending section 515.560 to eliminate the per diem limitation on authorized travelers' spending in Cuba, and to permit authorized travelers to import no more than $400 worth of goods from Cuba (including up to $100 in alcohol or tobacco products).

Certain micro-financing, business, and commercial import activities. OFAC is amending section 515.575 to authorize certain micro-financing activities and entrepreneurial and business training, such as for private businesses and agricultural operations. OFAC is adding new section 515.582 to authorize commercial imports of certain specified goods and services produced by independent Cuban entrepreneurs.

Certain financial transactions. OFAC is adding a general license in new section 515.584 to authorize depository institutions to open correspondent accounts at Cuban financial institutions to facilitate the processing of authorized transactions and to permit U.S. financial institutions to reject and process certain funds transfer transactions.

Regulatory interpretation of “cash in advance.” OFAC is amending section 515.533 to revise the regulatory interpretation of “cash in advance” from “cash before shipment” to “cash before transfer of title and control” to allow expanded financing options for authorized exports to Cuba.

Telecommunications. In order to better provide efficient and adequate telecommunications services between the United States and Cuba, OFAC is amending section 515.542 to generally authorize transactions that establish mechanisms to provide commercial telecommunications services linking third countries and Cuba and in Cuba. OFAC is amending section 515.578 to authorize persons subject to U.S. jurisdiction to provide additional services incident to internet-based communications and related to certain exportations and reexportations of communications items.

Certain transactions with Cuban nationals located outside of Cuba. OFAC is adding new section 515.585 to authorize U.S.-owned or -controlled entities in third countries to provide, with some limitations, goods and services to Cuban nationals in third countries. OFAC is amending section 515.505 to unblock accounts of Cuban nationals who have permanently relocated outside of Cuba. OFAC is amending section 515.579 to authorize funds transfers through the United States for the personal expenditures of employees, grantees, and contractors, and persons who share a common dwelling as a family member of such employees, grantees, and contractors, of third-country official missions in Cuba or any intergovernmental organization in which the United States is a member or holds observer status in Cuba. OFAC is adding new section 515.581 to authorize persons subject to U.S. jurisdiction to sponsor and participate in third-country professional meetings and conferences that are attended by Cuban nationals, and new section 515.583 to permit the provision of certain goods and services to Cuban national sailors sequestered aboard ships in U.S. ports.

Official government business. OFAC is amending section 515.562 to expand an existing authorization to cover all Cuba-related transactions by employees, grantees, and contractors of the U.S. Government, foreign governments, and certain international organizations in their official capacities.

Cuban official missions. To facilitate the reestablishment of diplomatic relations with Cuba, OFAC is adding new section 515.586 to authorize transactions with Cuban official missions and their employees in the United States.

Other transactions. OFAC is adding new section 515.580 to authorize insurance companies to offer global insurance policies that cover third-country nationals traveling to Cuba. OFAC is amending section 515.550 to authorize foreign vessels to enter the United States after engaging in certain trade with Cuba.

Because the amendments of the Regulations involve a foreign affairs function, Executive Order 12866 and the provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR part 515 as set forth below:

The BNSF Railway Company requested a temporary deviation from the normal operation of the drawbridge in order to perform the installation of new generators and the removal of the old festoon cable. These repairs and scheduled maintenance are necessary for the continued operation of the bridge. This deviation allows the draw of the Morgan City (Berwick Bay) Railroad Bridge across the Atchafalaya River, mile 17.5 (Gulf Intracoastal Waterway (Morgan City-Port Allen Alternate Route) mile 0.3), to remain closed to navigation for four consecutive hours in the morning and three hours in the afternoon with an opening in the middle to pass vessels. The deviation is effective from 7 a.m. to 11 a.m. and then again from 1 p.m. through 4 p.m. daily from January 26 through January 31, 2015.

Broadcast Notice to Mariners will be used to update mariners of any changes in this deviation.

The bridge has a vertical clearance of 4 feet above high water in the closed-to-navigation position and 73 feet above high water in the open-to-navigation position. Navigation on the waterway consists of tugs with tows, oil industry related work boats and crew boats, commercial fishing vessels and some recreational craft. In accordance with 33 CFR 117.5, the draw of the bridge shall open on signal. The Morgan City-Port Allen Landside route through Amelia, LA is the alternate route.

BNSF and the Coast Guard have coordinated the closure with waterway users, industry, and other Coast Guard units. This date and this schedule were chosen to minimize the significant effects on vessel traffic.

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

The BNSF Railway Company requested a temporary deviation from the operating schedule of the Galveston Causeway Railroad Vertical Lift Bridge across the Gulf Intracoastal Waterway, mile 357.2 west of Harvey Locks, at Galveston, Galveston County, Texas.

The bridge has a vertical clearance of 8.0 feet above mean high water, elevation 3.0 feet NAVD88, in the closed-to-navigation position and 73 feet above mean high water in the open-to-navigation position. In accordance with 33 CFR 117.5, the draw shall open on signal for the passage of vessels.

This temporary deviation allows the vertical lift bridge to remain closed to navigation from 7 a.m. through noon, daily, February 2 and February 3, 2015. During this time, the bridge owner will complete tie replacement, surfacing, and signal work. If the vessel can safely pass without an opening, the vessel may pass at the slowest safe speed. The bridge can open in case of emergency.

Navigation at the site of the bridge consists mainly of tows with barges and some recreational pleasure craft. Based on known waterway users, as well as coordination with those waterway users, it has been determined that this closure will not have a significant effect on these vessels. No alternate routes are available.

In accordance with 33 CFR 117.35, the draw bridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation.

This deviation from the operating regulations is authorized under 33 CFR 117.35

Executive Summary: Purpose: The rule changes benefit the public by providing more comprehensive and specific guidance regarding certain requirements relating to representation before the Office, applications for registration, examination procedures, amendment of applications, publication and post publication procedures, appeals, petitions, post registration practice, correspondence in trademark cases, classification of goods and services, and procedures under the Madrid Protocol. For the most part, the rule changes codify existing practice.

Summary of Major Provisions: As stated above, the Office is revising the rules in parts 2, 6, and 7 of title 37 of the Code of Federal Regulations to codify current Office practice and provide sufficient detail regarding miscellaneous requirements relating to representation before the Office, applications for registration, examination procedures, amendment of applications, publication and post publication procedures, appeals, petitions, post registration practice, correspondence in trademark cases, classification of goods and services, and procedures under the Madrid Protocol.

Costs and Benefits: This rulemaking is not economically significant under Executive Order 12866 (Sept. 30, 1993).

Proposed Rule and Request for Comments:

A proposed rule was published in the Federal Register on January 23, 2014, at 79 FR 3750, and in the Official Gazette on April 8, 2014. The Office received comments from two intellectual property organizations and one attorney. These comments are posted on the Office's Web site at http://www.uspto.gov/trademarks/law/FR_Comments_Misc_Changes.jsp , and are addressed below.

References below to “the Act,” “the Trademark Act,” or “the statute” refer to the Trademark Act of 1946, 15 U.S.C. 1051 et seq., as amended. References to “TMEP” or “ Trademark Manual of Examining Procedure” refer to the October 2014 edition.

The Office received many positive comments in favor of the rule changes and appreciates the public support. To streamline this Notice, such comments expressing support are not individually set forth and no specific responses to such comments are provided.

Comment: One commenter agreed with the proposal to remove existing § 2.38(b), but expressed concern regarding any possible effect the rule may have on existing registrations issued pursuant to sections 66(a) and 44(e) of the Act that were not required to indicate if the applied-for mark was being used by one or more related companies, rather than the applicant. Therefore, the commenter encouraged the Office to include a statement that registrations issued under previous versions of § 2.38(b) shall not be vulnerable to challenge due to the omission of information concerning use of the mark solely by related companies whose use inures to the benefit of the applicant under section 5 of the Act.

Response: As noted by the commenter, evidence of use of the mark in commerce is not required for registrations issued pursuant to sections 66(a) or 44(e) of the Act. Accordingly, the requirement under current § 2.38(b) that an applicant indicate when the applied-for mark is not being used by the applicant but is instead being used by one or more related companies whose use inures to the benefit of the applicant is not applicable to registrations issued pursuant to sections 66(a) or 44(e) of the Act. Because such requirement did not apply to registrations issued pursuant to sections 66(a) or 44(e) of the Act, the Office does not believe it is necessary to include a statement regarding the omission of such information in an application under sections 66(a) or 44(e) of the Act under the current rule.

Comment: One commenter inquired as to whether the amendment to add new § 2.62(c) would affect the Office's current practice of encouraging informal communication between applicants (or their representatives) and examining attorneys regarding issues that are capable of resolution by examiner's amendment, and encouraged the Office to investigate potential means for allowing formal responses to be submitted via email.

Response: The Office continues to encourage informal communication between applicants (or their representatives) and examining attorneys regarding issues that are capable of resolution by examiner's amendment, and the revision to § 2.62 in no way affects the Office's position on such informal communications. In addition, the Office is continually investigating alternative procedures that may assist both examining attorneys and applicants (or their representatives) in expediting the examination process.

Comment: Another commenter noted that under proposed § 2.63(a)(2), if a petition to the Director under § 2.146 is denied, the applicant is granted six months from the “date” of the Office action that repeated the requirement(s), or thirty days from the date of the decision on the petition, whichever is later, to comply with the repeated requirement(s). By contrast, the commenter noted that under proposed § 2.63(c), if a petition to the Director under § 2.146 is denied, the applicant is granted six months from the “date of issuance” of the Office action that repeated the requirement(s), or made it final, or thirty days from the date of the decision on the petition, whichever date is later, to comply with the requirement(s). The commenter suggested that, in order to ensure clarity, the language in proposed §§ 2.63(a)(2) and 2.63(c) be made consistent.

Response: As both the applicable response deadlines after a denial of a petition to the Director under § 2.146 and the statement that a requirement that is the subject of a petition decided by the Director may not subsequently be the subject of an appeal to the Trademark Trial and Appeals Board (TTAB) are set out in new § 2.63(c), such information has been removed from § 2.63(a)(2).

Comment: One commenter noted that a process to allow an applicant to request an amendment not specifically listed in § 2.77(a) between the issuance of the notice of allowance and the filing of the statement of use should be available, but the denial of a petition because the issues require review by the examining attorney introduces uncertainty and delay into the process. The commenter therefore encouraged the Office to consider adopting a process similar to the on-line process currently available to request an amendment between publication of the application for opposition and issuance of the notice of allowance.

Response: Under amended § 2.77(b), if the Director determines that a proposed post-notice of allowance and pre-statement of use amendment does not require review by the examining attorney, the petition will be granted, and the amendment entered into the record. If the Director determines that the proposed post-notice of allowance and pre-statement of use amendment requires review by the examining attorney, the petition will be denied, and the applicant may resubmit the proposed amendment with the statement of use. In the case of proposed amendments submitted after the issuance of the notice of allowance but prior to the submission of a statement of use, regardless of jurisdiction with the examining attorney, an Office action detailing a refusal or requirement that may arise from a proposed amendment cannot issue at that time because it would create a response deadline that differed from the statement of use filing deadline. The complexity of tracking these two different concurrent deadlines presents system problems for the Office and could create confusion for applicants, examining attorneys, and the TTAB that may lead to files being mistakenly abandoned for failure to file a timely response or statement of use and missed opportunities for appealing final requirements and refusals. Additionally, because an examining attorney cannot issue a refusal or requirement after the issuance of the notice of allowance but before the filing of the statement of use, if the Director determined that a proposed amendment required review by an examining attorney and granted the petition, an applicant might mistakenly believe that the proposed amendment has been granted because of the delay in issuing an Office action detailing the issues with the proposed amendment until after the submission of the statement of use. As written, proposed § 2.77(b) will expedite the entry of acceptable amendments, facilitate clarity, and provide the applicant with the most accurate and timely information regarding the status of a proposed amendment.

Comment: One commenter expressed its support for the proposed revision to § 2.81(b) to remove the list of items that will be included on the notice of allowance to allow greater flexibility in the format of the notice of allowance for changes that may occur in conjunction with the Office's “Trademarks Next Generation” information-technology initiative, but encouraged the Office to seek stakeholder input before making substantial changes to the current format of the notice of allowance.

Response: The Office continues to welcome stakeholder input regarding the “Trademarks Next Generation” information technology initiative and will provide sufficient notice prior to revising forms.

Comment: One commenter stated the proposed amendment to § 7.11(a)(3)(ii) was not consistent with the Common Regulations under the Madrid Agreement Concerning the International Registration of Marks and the Protocol Relating to that Agreement (as in force on January 1, 2013) (hereinafter “Common Regulations”), and that under the Common Regulations, the requirement for both black-and-white and color reproductions of the mark applies to all applications, whether filed on paper or electronically.

Response: Based on the concern raised by the commenter about consistency with the Common Regulations, the Office will explore the matter further and is withdrawing the proposed amendment to § 7.11(a)(3)(ii) at this time.

Comment: Another commenter stated that the structure of § 7.23 should be revisited, as the rule appears to apply only to assignments, while Article 9 of the Madrid Protocol and Rule 25 of the Common Regulations apply broadly to all possible ownership changes, including following the death of the holder, judicial decisions, and mergers. In those contexts, the requirement for a “good-faith effort” to obtain the signature of the former owner should be revisited.

Response: While § 7.23 refers to “assignments,” both in the title and in the body, the Office interprets this term broadly to encompass not only assignments but also other types of conveyances, such as mergers and court-ordered changes. This corresponds with the practice in the Office's Assignment Recordation Branch, where the term “assignments” is used in the title of the unit and in documentation, but is interpreted to include not only assignments but also other types of conveyances, such as changes of name and security interests. In order to ensure clarity, the Office has revised § 7.23(a)(5) to indicate that, when the holder no longer exists, the assignee does not have to make a good-faith effort to obtain the assignor's signature.

Comment: Another commenter stated that the amendment to § 7.23(a)(6) does not cover all possible scenarios under which an interested party would be qualified to request a change of ownership through the Office, which appears contrary to Common Regulations Rules 25(1)(b) and 25(2)(a)(iv). Furthermore, the commenter alleged that § 7.23(a)(6) is redundant and should be expunged since § 7.23(a)(4) mentions entitlement requirements, and the Common Regulations do not impose the limitations set forth in § 7.23(a)(6) on an assignee of an international registration to be able to record an assignment through the Office.

Response: While the International Bureau permits requests for changes of ownership to be presented through the office of a contacting party, the Office is not required to do so. The rule change broadens the ability of U.S. trademark owners, who otherwise could not obtain the signature of the former holder after a good-faith effort, to update ownership information with the International Bureau. While the revised rule could not be invoked by parties with no connection to the Office ( e.g., a U.S. domestic application/registration or request for extension of protection), those parties have a remedy. They have the option to file a petition to the Director and, upon a showing of extraordinary circumstances, request a waiver of the requirements of § 7.23(a)(6). Since there are transferees who do not qualify to invoke the amended rule, § 7.23(a)(6) is not redundant.

Comment: One commenter addressed the proposed amendment to § 7.24(b)(5)(ii) to require that a request, submitted through the Office, to record a restriction, or the release of a restriction, that is the result of an agreement between the holder of the international registration and the party restricting the holder's right of disposal must include a statement indicating that, after making a good-faith effort, the signature of the holder of the international registration could not be obtained for the request to record the restriction, or release of the restriction, and such statement must be signed and verified or supported by declaration under § 2.20. The commenter noted that the proposed amendment appears to be acceptable in so far as it purports to implement Common Regulations Rule 20(1)(b), but alleged that the current provisions of § 7.24 are not in compliance with the Common Regulations because § 7.24(a) offers the opportunity to record a restriction through the Office only if the party who obtained the restriction is a national of, is domiciled in, or has a real and effective industrial or commercial establishment in the U.S. The commenter believes that Common Regulations Rule 20(1)(a) dictates that whether or not the holder is a U.S. subject should control.

Response: While Common Regulations Rule 20(1)(a) permits the office of any contracting party of the holder to inform the International Bureau that the holder's right to dispose of an international registration has been restricted, it does not require the office of the contracting party to do so. Accordingly, the Office is not required to inform the International Bureau that the holder's right to dispose of an international registration has been restricted.

Comment: One commenter stated that the rationale for the amendment to § 7.24(b)(7), to indicate that a request to record a restriction, or the release of a restriction, must include an indication that the restriction, or the release of the restriction, of the holder's right of disposal of the international registration applies to the designation to the U.S. or an international registration that was originally based on a U.S. application or registration was unclear. The commenter asked if there was a need for equal treatment in two very distinct situations, such as restriction on the right to dispose of an international registration having effect in the U.S. and an international registration having no such effect, which would not be a remedy. The commenter suggested amending § 7.24(a)(2) to refer to the holder of the international registration instead of the party who obtained the restriction, or deleting or amending § 7.24(b)(4).

Response: While the International Bureau permits requests to record the holder's right to dispose of an international registration to be presented through an office of a contracting party, the Office is not required to do so. The proposed rule change broadens the ability of U.S. trademark owners, who otherwise could not obtain the signature of the holder after a good-faith effort, to record the restriction of the right to dispose with the International Bureau. While the proposed rule could not be invoked by a party with no connection to the Office ( e.g., U.S. domestic application/registration or request for extension of protection), such a party has a remedy. The party has the option to file a petition to the Director and, upon a showing of extraordinary circumstances, request a waiver of the requirements of § 7.24(b)(7).

The Office is amending § 2.17(d)(1) to remove the reference to the number of powers of attorney that can be filed via the Trademark Electronic Application System (“TEAS”) for existing applications or registrations that have the identical owner and attorney. Prior to this amendment, the TEAS Revocation of Attorney/Domestic Representative and/or Appointment of Attorney/Domestic Representative form indicated that up to 300 applications or registrations could be amended per request. The amendment is intended to remove outdated information, and allows for greater flexibility for future enhancements to TEAS.

The Office is amending § 2.19(b) to require compliance with § 11.116, rather than § 10.40, as part 10 of this chapter has been removed and reserved (78 FR 20180 (April 3, 2013)) and § 11.116 now sets out the requirements for terminating representation.

The Office is amending § 2.22(a)(19) to indicate that if a TEAS Plus applicant owns one or more registrations for the same mark shown in the application, and the last listed owner of the prior registration(s) differs from the owner of the application, the application must include a claim of ownership for the prior registration(s) in order to be entitled to the reduced filing fee under § 2.6(a)(1)(iii). This limits the circumstances under which a TEAS Plus applicant is required to claim ownership of a prior registration and is consistent with the revision to the claim of ownership requirements in § 2.36.

The Office is amending § 2.36 to indicate that an applicant is only required to claim ownership of prior registrations for the same or similar marks if the owner listed in the application differs from the owner last listed in the Office's database for such prior registrations. This is consistent with existing practice.

The Office is amending § 2.38(b) to remove the requirement that an application indicate that, if the applied-for mark is not being used by the applicant but is being used by one or more related companies whose use inures to the benefit of the applicant under section 5 of the Act, such fact must be indicated in the application.

The Office is re-designating § 2.38(c) as § 2.38(b), as the requirement in current § 2.38(b) is being removed.

The Office is adding new § 2.62(c) to specify that responses to Office actions must be filed through TEAS, transmitted by facsimile, mailed, or delivered by hand, and that responses sent by email will not be accorded a date of receipt. This is consistent with existing practice.

The Office is amending the title of § 2.63 from “Reexamination” to “Action after response,” as revised § 2.63 incorporates a discussion of reexamination, the filing of petitions and appeals, and abandonments.

The Office is amending § 2.63(a) to clarify that after submission of a response by the applicant, the examining attorney will review all statutory refusal(s) and/or requirement(s) in light of the response. This is consistent with TMEP section 713.

The Office is adding § 2.63(a)(1) to clarify that the applicant may respond to a non-final action that maintains any requirement(s) or substantive refusal(s) by filing a timely response to the examiner's action. This is consistent with TMEP section 713. To ensure clarity, the Office is adding a cross-reference to § 2.62(a).

The Office is adding § 2.63(a)(2) to clarify that the applicant may respond to a non-final action that maintains any requirement(s) by filing a petition to the Director under § 2.146 if the subject matter of the requirement(s) is appropriate for petition. This is consistent with TMEP sections 713 and 1702. In addition, as both the applicable response deadlines after a denial of a petition to the Director under § 2.146 and the statement that a requirement that is the subject of a petition decided by the Director may not subsequently be the subject of an appeal to the TTAB are set out in new § 2.63(c), such information has been removed from § 2.63(a)(2).

The Office is amending § 2.63(b) to clarify that the examining attorney may make final a refusal or requirement upon review of a response. This is consistent with current § 2.64(a) and TMEP sections 713 and 714.03. To ensure clarity, the Office is updating the wording to remove a reference to “request for reconsideration” because § 2.63(a) discusses responses to non-final actions, and the Office uses “request for reconsideration” to refer to responses after final actions.

The Office is adding § 2.63(b)(1) to clarify that the applicant may respond to a final action that maintains any substantive refusal(s) by filing an appeal to the TTAB under §§ 2.141 and 2.142. This is consistent with TMEP section 1501.01. To ensure clarity, the Office is updating the wording to explicitly state that the applicant may additionally respond by filing a timely request for reconsideration under § 2.63(b)(3) that seeks to overcome any substantive refusal(s) or outstanding requirement(s) maintained in the final action. This is consistent with TMEP section 715.03.

The Office is adding § 2.63(b)(2) to clarify that the applicant may respond to a final action that withdraws all substantive refusals but maintains any requirement(s) either by filing an appeal to the TTAB under §§ 2.141 and 2.142 or by filing a petition to the Director under § 2.146, if the subject matter of the requirement(s) is procedural, and therefore appropriate for petition. This is consistent with current § 2.63(b) and TMEP sections 1501.01 and 1704. To ensure clarity, the Office is updating the wording to explicitly state that the applicant may additionally respond by filing a timely request for reconsideration under § 2.63(b)(3) that seeks to comply with any outstanding requirement(s) maintained in the final action. This is consistent with TMEP section 715.03.

The Office is adding § 2.63(b)(3) to clarify that the applicant may file a request for reconsideration of the final action prior to the expiration of the time for filing an appeal to the TTAB or a petition to the Director, and that the request does not stay or extend the time for filing an appeal or petition. This is consistent with current § 2.64(b) and TMEP section 715.03. To ensure clarity, the Office is updating the wording to indicate that the request for reconsideration should seek to overcome any substantive refusal(s) and/or comply with any outstanding requirement(s), and that the Office will enter amendments accompanying requests for reconsideration if the amendments comply with the rules of practice and the Act. This is consistent with TMEP sections 715.02 and 715.03. In addition, the proposed language indicating that the request for reconsideration must be properly signed is being removed from § 2.63(b)(3), as this requirement is already specified in § 2.193(e)(2).

The Office is adding § 2.63(b)(4) to clarify that the filing of a request for reconsideration that does not result in the withdrawal of all refusals and requirements, without the filing of a timely appeal or petition, will result in abandonment of the application for incomplete response. This is consistent with section 12(b) of the Act and current § 2.65(a).

The Office is adding § 2.63(c) to clarify both that if a petition to the Director under § 2.146 is denied, the applicant will have until six months from the date of issuance of the Office action that repeated the requirement(s), or made it final, or thirty days from the date of the decision on the petition, whichever date is later, to comply with the requirement(s), and that a requirement that is the subject of a petition decided by the Director subsequently may not be the subject of an appeal to the TTAB. This is consistent with current § 2.63(b) and TMEP sections 1501.01 and 1702.

The Office is adding § 2.63(d) to clarify that if an amendment to allege use is filed during the six-month response period after issuance of a final action, the examining attorney will examine the amendment, but the filing of the amendment does not stay or extend the time for filing an appeal to the TTAB or a petition to the Director. This is consistent with current § 2.64(c)(1) and TMEP sections 711 and 1104.

The Office is removing and reserving § 2.64 and is incorporating updated final action procedures into revised § 2.63.

The Office is amending § 2.65(a) both to clarify that an application will be deemed abandoned if an applicant fails to respond, or respond completely, to an Office action within six months of the issuance date, but a timely petition to the Director or notice of appeal to the TTAB, if appropriate, is considered to be a response that avoids abandonment, and to revise the reference to § 2.63(b) so as to reference § 2.63(a) and (b). The clarification is consistent with TMEP section 718.03, and the revision to the reference accounts for the amendment to § 2.63, which sets out the conditions for a petition under § 2.146 in § 2.63(a) and (b) instead of only § 2.63(b). To ensure clarity, the Office is adding a cross-reference to § 2.63(b)(4).

The Office is adding § 2.65(a)(1) to clarify that if an applicant fails to timely respond to an Office action, but all refusals and/or requirements are expressly limited to certain goods and/or services, the application will be abandoned only as to those goods and/or services. This is consistent with current § 2.65(a) and TMEP section 718.02(a).

The Office is adding § 2.65(a)(2) to clarify that an applicant may, in certain situations, be granted thirty days, or to the end of the response period set forth in the action, whichever is longer, to provide information omitted from a response before the examining attorney considers the issue of abandonment. In order to ensure clarity, certain wording in the rule has been changed from passive to active voice. This is consistent with current § 2.65(b) and TMEP section 718.03(b).

The Office is amending § 2.65(b) to clarify that an application will be abandoned if an applicant expressly abandons the application pursuant to § 2.68. This is consistent with TMEP section 718.01.

The Office is amending § 2.65(c) to clarify that an application under section 1(b) of the Act will be abandoned if the applicant fails to file a timely statement of use under § 2.88 or a request for an extension of time for filing a statement of use under § 2.89. This is consistent with section 1(d)(4) of the Act and TMEP sections 1108.01 and 1109.04.

The Office is amending § 2.68(a) to indicate that, consistent with existing practice, a request for abandonment or withdrawal may not subsequently be withdrawn. This is intended to provide applicants, registration owners, and the public assurance of the accuracy of the status of applications or registrations after filings are received by the Office.

The Office is amending § 2.68(b) for clarity by moving the “in any proceeding before the Office” clause to the end of the sentence.

The Office is amending § 2.77(b) to indicate that amendments not listed in § 2.77(a) may be entered in the application in the time period between issuance of the notice of allowance and submission of a statement of use only with the express permission of the Director, after consideration on petition under § 2.146. This is consistent with TMEP sections 1107 and 1505.01(d), which currently require a waiver of § 2.77 on petition. If the Director determines that the amendment requires review by the examining attorney, the petition will be denied and the amendment may be resubmitted with the statement of use.

The Office is amending § 2.81(b) to remove the list of items that will be included on the notice of allowance. This change will allow greater flexibility in the format of the notice of allowance for changes that may occur in conjunction with the Office's “Trademarks Next Generation” information-technology initiative. As a matter of practice, at this time, the Office plans to continue to maintain the current format of the notice of allowance.

The Office is amending § 2.84(b) to clarify that an application that is not the subject of an inter partes proceeding before the TTAB may be amended after the mark has been published for opposition, but before the certificate of registration has been issued under section 1(a), 44, or 66(a) of the Act, or before the notice of allowance has been issued in an application under section 1(b) of the Act, if the amendment meets the requirements of §§ 2.71, 2.72, and 2.74. This is consistent with existing practice.

The Office is amending § 2.142(f)(3) and (f)(6) to remove the references to § 2.64, as the Office is removing and reserving § 2.64, with the sections of § 2.64 relevant to § 2.142(f)(3) and (f)(6) incorporated into revised § 2.63.

The Office is amending § 2.145(a) to add registrants who have filed an affidavit or declaration under section 71 of the Act and are dissatisfied with a decision of the Director to the list of parties eligible to appeal to the U.S. Court of Appeals for the Federal Circuit. This is consistent with TMEP section 1613.18(d).

The Office is amending § 2.146(a)(1) and (g) to replace references to § 2.63(b) with references to § 2.63(a) and (b), as the amended rules will list conditions for a petition under § 2.146 in § 2.63(a) and (b) instead of only § 2.63(b). In addition, in order to ensure clarity, the Office is amending § 2.146(g) to replace a reference to § 2.65 with a reference to § 2.65(a).

The Office is amending § 2.171(b)(2)(i) to clarify that when the Office receives notification from the International Bureau of the World Intellectual Property Organization that an international registration has been divided due to a change in ownership with respect to some but not all of the goods and/or services, the Office will update Office records to reflect the change in ownership, divide out the assigned goods and/or services from the registered extension of protection (parent registration), and publish notice of the parent registration in the Official Gazette. The Office does not record the partial change of ownership in the Assignment Recordation Branch (formerly Assignment Services Branch), and only issues an updated certificate for the parent registration to the owner upon payment of the fee required by § 2.6. This is consistent with existing practice.

The Office is amending § 2.172 to clarify that a surrender for cancellation may not subsequently be withdrawn. This is consistent with existing practice.

The Office is amending § 2.185(a) to indicate that deficiencies in renewal applications may be corrected after notification from the Office. This is consistent with existing practice.

The Office is amending § 2.198(a)(1) by adding § 2.198(a)(1)(viii) to include affidavits under section 71 of the Act in the list of documents excluded from the Office's Priority Mail Express® (formerly Express Mail®) procedure. This is consistent with the handling of corresponding affidavits under section 8 of the Act. In connection with this addition, the Office is revising § 2.198(a)(1)(vi) and § 2.198(a)(1)(vii) for clarity.

The Office is amending § 6.1(5) to add the wording “or veterinary” to the entry “dietetic food and substances adapted for medical use” in the listing of goods for International Class 5. This is consistent with the current heading for the international class as established by the Committee of Experts of the Nice Union and set forth in the International Classification of Goods and Services for the Purposes of the Registration of Marks published annually by the World Intellectual Property Organization on its Web site.

The Office had proposed to amend § 7.23(a)(5) to require that a request to record an assignment of an international registration submitted through the Office include a statement that, after making a good-faith effort, the assignee could not obtain the assignor's signature for the request to record the assignment and that the statement be signed and verified or supported by declaration under § 2.20. In order to ensure clarity, the Office is revising the amendment to § 7.23(a)(5) to require that a request to record an assignment of an international registration submitted through the Office include a statement that either the assignee could not obtain the assignor's signature for the request to record the assignment because the holder no longer exists, or, after a good-faith effort, the assignee could not obtain the assignor's signature for the request to record the assignment. This revision will ensure that, when possible, assignees make a good-faith effort to obtain the assignor's signature before invoking this rule and requesting the Office to forward the assignment document to the International Bureau.

The Office is amending § 7.23(a)(6) to indicate that a request to record an assignment of an international registration submitted through the Office must include an indication that the assignment applies to the designation to the United States (“U.S.”) or an international registration that was originally based on a U.S. application or registration. This revision is intended to ensure that an assignee of an international registration based on a U.S. registration or application is treated the same as an assignee of a designation to the U.S. Prior to this revision, the owner of an international registration based on a U.S. registration or application was required to file a petition to waive § 7.23(a)(6).

The Office had proposed to amend § 7.24(b)(5)(ii) to require that a request, submitted through the Office, to record a restriction, or the release of a restriction, that is the result of an agreement between the holder of the international registration and the party restricting the holder's right of disposal must include a statement indicating that, after making a good-faith effort, the signature of the holder of the international registration could not be obtained for the request to record the restriction, or release of the restriction, and such statement must be signed and verified or supported by declaration under § 2.20. In order to ensure clarity, the Office is revising the amendment to § 7.24(b)(5)(ii) to require, for a request to record the restriction or release of the restriction, a statement either that the holder of the international registration could not obtain the signature of the party restricting the holder's right of disposal because the party restricting the holder's right of disposal no longer exists, or, that after a good-faith effort, the holder of the international registration could not obtain the signature of the party restricting the holder's right of disposal. This revision will ensure that, when possible, holders of international registrations make a good-faith effort to obtain the signature of the party restricting the holder's right of disposal before invoking this rule and requesting the Office to forward the document to the International Bureau.

The Office is amending § 7.24(b)(7) to indicate that a request to record a restriction, or the release of a restriction, must include an indication that the restriction, or the release of the restriction, of the holder's right of disposal of the international registration applies to the designation to the U.S. or an international registration that was originally based on a U.S. application or registration. This revision is intended to ensure that an assignee of an international registration based on a U.S. registration or application is treated the same as an assignee of a designation to the U.S. Prior to this revision, the owner of an international registration based on a U.S. registration or application was required to file a petition to waive § 7.24(b)(7).

The Office is amending § 7.25(a) to add §§ 2.21, 2.76, 2.88, and 2.89 to the list of sections in part 2 not applicable to an extension of protection under section 66(a) of the Act. This is consistent with existing practice as these sections in part 2 only concern applications under sections 1 or 44 of the Act.

The Office is amending § 7.31 by revising the introductory text and § 7.31(a)(3) to require that a request to transform an extension of protection to the U.S. into a U.S. application specify the goods and/or services to be transformed. This revision is intended to ensure that the Office transforms an accurate listing of goods and/or services.

The Office is redesignating current § 7.31(a)(3) as § 7.31(a)(4) and current § 7.31(a)(4) as new § 7.31(a)(5) because current § 7.31(a)(3) is being revised to require that a request to transform an extension of protection to the U.S. into a U.S. application specify the goods and/or services to be transformed.

Administrative Procedure Act: The changes in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of a statute is interpretive); Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims).

Accordingly, prior notice and opportunity for public comment for the rule changes are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice,” quoting 5 U.S.C. 553(b)(A)). However, the Office chose to seek public comment before implementing the rule to benefit from the public's input.

Regulatory Flexibility Act: As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, neither a Regulatory Flexibility Act analysis, nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), is required. See 5 U.S.C. 603.

In addition, for the reasons set forth herein, the Deputy General Counsel for General Law of the United States Patent and Trademark Office has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b). This rule involves changes to rules of agency practice and procedure. The primary impact of the rule is to provide greater clarity as to certain requirements relating to representation before the Office, applications for registration, examination procedures, amendment of applications, publication and post publication procedures, appeals, petitions, post registration practice, correspondence in trademark cases, classification of goods and services, and procedures under the Madrid Protocol. For the most part, the rule changes are intended to codify existing practice. The burdens, if any, to all entities, including small entities, imposed by these rule changes will be minor. Additionally, in a number of instances, the rule changes will lessen the burdens on applicants. Therefore, this rule will not have a significant economic impact on a substantial number of small entities.

Executive Order 12866: This rule has been determined not to be significant for purposes of Executive Order 12866.

Executive Order 13563 (Improving Regulation and Regulatory Review): The Office has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule changes; (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 Office will submit a report containing the final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this rule 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 rule change is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

Unfunded Mandate Reform Act of 1995: The Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ) requires that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule will have no such effect on State, local, and tribal governments or the private sector.

Paperwork Reduction Act: This rule involves information collection requirements which are subject to review by the U.S. Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). The Office has determined that there will be no new information collection requirements or impacts to existing information collection requirements associated with this rule. The collections of information involved in this rule have been reviewed and previously approved by OMB under control numbers 0651-0009, 0651-0050, 0651-0051, 0651-0054, 0651-0055, 0651-0056, and 0651-0061.

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.

For the reasons given in the preamble and under the authority contained in 15 U.S.C. 1123 and 35 U.S.C. 2, as amended, the Office amends parts 2, 6, and 7 of title 37 as follows:

Throughout this document wherever “we,” “us” or “our” is used, it is intended to refer to the EPA. Information is organized as follows:

On September 21, 2006, the EPA promulgated a final rule revising the 1997 24-hour primary and secondary National Ambient Air Quality Standards (NAAQS) for PM 2.5 from 65 micrograms per cubic meter (μg/m 3 ) to 35 μg/m 3 (October 17, 2006, 71 FR 61144).

The interstate transport provisions in Clean Air Act (CAA) section 110(a)(2)(D)(i) (also called “good neighbor” provisions) require each state to submit a State Implementation Plan (SIP) that prohibits emissions that will have certain adverse air quality effects in other states. CAA section 110(a)(2)(D)(i) identifies four distinct elements related to the impacts of air pollutants transported across state lines. In this action, the EPA is addressing the first two elements of this section, specified at CAA section 110(a)(2)(D)(i)(I), 1 for the 2006 24-hour PM 2.5 NAAQS.

The first element of CAA section 110(a)(2)(D)(i)(I) requires that each SIP for a new or revised NAAQS contain adequate measures to prohibit any source or other type of emissions activity within the state from emitting air pollutants that will “contribute significantly to nonattainment” of the applicable NAAQS in another state. The second element of CAA section 110(a)(2)(D)(i)(I) requires that each SIP prohibit any source or other type of emissions activity in the state from emitting pollutants that will “interfere with maintenance” of the applicable NAAQS in any other state.

On May 14, 2014, we proposed approval of the portion of Oregon's June 28, 2010, submission that addresses the CAA section 110(a)(2)(D)(i)(I) requirements for the 2006 24-hour PM 2.5 NAAQS (79 FR 27528). An explanation of the CAA requirements and implementing regulations that are met by this SIP submission, a detailed explanation of the submission, and the EPA's reasons for the proposed action were provided in the notice of proposed rulemaking on May 14, 2014, and will not be restated here (79 FR 27528). The public comment period for our proposed action ended on June 13, 2014.

The EPA received one anonymous adverse comment on the May 14, 2014, proposed approval (79 FR 27528). The EPA has evaluated the comment, as discussed below, and has determined that Oregon's 2010 Interstate Transport SIP submission addressing the 2006 24-hour PM 2.5 NAAQS is consistent with the CAA. Therefore the EPA is approving the Oregon 2010 Interstate Transport SIP as meeting the requirements of CAA section 110(a)(2)(D)(i)(I) for the 2006 24-hour PM 2.5 NAAQS. Following is the comment and the EPA's response.

Comment: “EPA's analysis of significant contribution to nonattainment and maintenance areas in down-wind states must be done for ALL NAAQS pollutants, not just the 2006 PM 2.5 NAAQS. This would ensure that Oregon's PM 2.5 emissions are not affecting the nonattainment or maintenance of ALL NAAQS in other States. The CAA specifically states that, `Each such plan shall . . . contain adequate provisions (i) prohibiting . . . any source or other type of emissions activity within the State from emitting ANY air pollutant in amounts which will (I) contribute significantly to nonattainment in, or interfere with maintenance by, any other State with respect to ANY such national primary or secondary ambient air quality standard,' (Emphasis on `any'). This was recently affirmed by the Supreme Court in EME Homer City v. EPA, `To tackle the problem, Congress included a Good Neighbor Provision in the Clean Air Act (Act or CAA). That provision, in its current phrasing, instructs States to prohibit in-state sources “from emitting any air pollutant in amounts which will . . . contribute significantly' to downwind States' “nonattainment . . ., or interfere with maintenance,” of ANY EPA promulgated national air quality standard.” (Again, emphasis on `any'). For this reason the EPA can't approve Oregon's Interstate Transport SIP because it, and EPA's analysis, doesn't include an analysis which determines that Oregon doesn't contribute to another State's nonattainment or maintenance for ALL NAAQS pollutants.”

Response: This comment addresses the requirements of CAA section 110(a)(2)(D)(i)(I). This provision, the “good neighbor” provision, requires each State Implementation Plan to prohibit “any source or other type of emissions activity within the State from emitting any air pollutants in amounts which will . . . contribute significantly to nonattainment in or interfere with maintenance by, any other state with respect to any . . . primary or secondary [NAAQS].” 42 U.S.C. 7410(a)(2)(D)(i). The recent Supreme Court decision in Environmental Protection Agency v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014), addressed the requirements of this provision and reversed the prior DC Circuit Court of Appeals decision vacating the EPA's Cross-State Air Pollution Rule. The commenter quotes from the section of the Supreme Court decision that discusses the historical development (from 1963 onward) of the EPA's interstate transport policy (the `good neighbor' provision). The quoted language essentially tracks the statutory text of CAA section 110(a)(2)(D)(i)(I), which describes specific elements that must be included in State Implementation Plans to address pollution that is transported across state lines. As the Supreme Court decision in EME Homer City confirmed, pursuant to CAA section 110(a)(1), state plans to address these requirements must be submitted to the Administrator within three years of the promulgation or revision of a NAAQS. EME Homer City, 134 S. Ct. at 1600.

The EPA interprets the comment as stating that the CAA section 110(a)(2)(D)(i)(I) provisions of Oregon's 2010 Interstate Transport SIP submission for the 2006 24-hour PM 2.5 NAAQS should address, in addition to emissions that significantly contribute to nonattainment or interfere with maintenance of the 2006 24-hour PM 2.5 NAAQS, any emissions that significantly contribute to nonattainment or interfere with maintenance of all other NAAQS. The EPA disagrees. Because it is the promulgation or revision of a NAAQS that triggers the requirement to submit a SIP addressing the requirements of CAA section 110(a)(2)(D)(i)(I), the EPA interprets the CAA as requiring each such SIP to address the CAA section 110(a)(2)(D)(i)(I) requirements only with respect to the specific NAAQS at issue. In other words, each CAA section 110(a)(2)(D)(i)(I) SIP submission need only address the specific NAAQS which had been promulgated or revised by the EPA thereby triggering the SIP submission requirement. Because Oregon submitted this SIP to address the applicable requirements of CAA section 110(a)(2)(D)(i)(I) with respect to the 2006 24-hour PM 2.5 NAAQS, it need only demonstrate that the SIP is adequate to prohibit emissions that significantly contribute to nonattainment or interfere with maintenance of the 2006 24-hour PM 2.5 NAAQS in other states. Any emissions that have such impacts with respect to other NAAQS must be addressed as appropriate in the CAA section 110(a)(2)(D)(i)(I) SIP submissions for those other NAAQS. In its May 14, 2014, action, the EPA proposed to conclude that Oregon's 2010 Interstate Transport SIP submission addressed the requirements of CAA section 110(a)(2)(D)(i)(I) with respect to the 2006 24-hour PM 2.5 NAAQS (79 FR 27528). The commenter has offered no data or evidence to suggest that the submission does not do so.

The EPA is approving the portion of the June 28, 2010, SIP submission from Oregon that addresses the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2006 24-hour PM 2.5 NAAQS. The EPA is determining that Oregon's existing SIP contains adequate provisions to ensure that air emissions from Oregon will not significantly contribute to nonattainment or interfere with maintenance of the 2006 24-hour PM 2.5 NAAQS in any other state. This action is being taken under section 110 of the CAA.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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 this action does not involve technical standards; and does not provide the 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).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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. The 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 17, 2015. 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)).

40 CFR part 52 is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

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-2014-0540 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 March 17, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0540, 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 CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (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.html. 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 November 7, 2014 (79 FR 66347) (FRL-9918-69), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E8182) by Bayer CropScience, 2 T.W. Alexander Dr., P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.415 be amended by establishing tolerances for residues of the fungicide fosetyl-Al, aluminum tris ( O -ethylphosphonate), in or on pepper/eggplant, subgroup 8-10B at 0.01 parts per million (ppm) and non-bell (chili) pepper, dried fruit at 0.01 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is not establishing a separate tolerance for residues of fosetyl-Al on pepper, non-bell (chili), dry fruit. The reason for this is explained in Unit IV.D.

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 fosetyl-Al including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fosetyl-Al 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.

The major target organs following repeated oral exposure to fosetyl-Al are the reproductive system in the dog (testicular degeneration: Spermatocytic and/or spermatidic giant cells in the lumen of the seminiferous tubules) and the urinary system in the rat (histopathological changes in the kidney, impairment of calcium/phosphorus metabolism, calculi and hyperplasia in the urinary tract, bladder tumors). There is no concern for increased quantitative or qualitative susceptibility of the young following in utero (rats and rabbits) and pre-and postnatal exposure (rats) to fosetyl-Al. Also, there is no evidence of developmental toxicity, reproductive toxicity in the rat, neurotoxicity, or immunotoxicity at dose levels that do not exceed the limit dose. The microscopic finding in the dog testes may be considered an isolated finding in light of the lack of any functional deficits in the rat 2-generation reproductive toxicity study and the lack of effects on the rat reproductive organs following chronic exposure. Additionally, a clear no-observed-adverse-effect level (NOAEL) was established for the effect observed in the dog and was selected as a suitable point of departure (POD) for the chronic dietary (all populations) exposure scenario. Fosetyl-Al is negative for carcinogenicity except at extremely high doses (>limit dose) in rats and mice, and it did not show any genotoxic potential (classified as not likely to be carcinogenic to humans). Fosetyl-Al is not acutely toxic via the oral, dermal, and inhalation routes. It produces severe eye irritation, is not a dermal irritant, and is negative for dermal sensitization.

Specific information on the studies received and the nature of the adverse effects caused by fosetyl-Al as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Fosetyl-Aluminum [Fosetyl-Al]: Human Health Risk Assessment for the Establishment of Tolerances with No U.S. Registration in/on Pepper/eggplant, Subgroup 8-10B and Pepper, Non-bell (Chili), Dry Fruit” in docket ID number EPA-HQ-OPP-2014-0540.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern 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 fosetyl-Al used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fosetyl-Al, EPA considered exposure under the petitioned-for tolerances as well as all existing fosetyl-Al tolerances in 40 CFR 180.415. EPA assessed dietary exposures from fosetyl-Al 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. No such effects were identified in the toxicological studies for fosetyl-Al; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA's unrefined chronic analysis is based on tolerance-level residues and 100% crop treated (PCT) assumptions. Default processing factors were used for all crops except for citrus where processing studies showed no residue concentration; thus, the processing factor was set to one for processed citrus commodities.

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

iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for fosetyl-Al. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fosetyl-Al in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fosetyl-Al. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Environmental fate properties suggest that fosetyl-Al is not likely to reach ground or surface water under most conditions, and if it does reach surface water, it is expected to degrade rapidly. Using the Screening Concentration in Ground Water (SCI-GROW) model, the estimated drinking water concentration (EDWC) of fosetyl-Al for chronic exposures for non-cancer assessments is estimated to be 0.006 parts per billion (ppb) for ground water. Thus, the ground water EDWC of 0.006 ppb was directly incorporating into the chronic dietary risk assessment.

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). Fosetyl-Al is currently registered for the following use that could result in residential exposure: Turf. EPA assessed residential exposure using the following assumptions: Residential handler and residential post-application exposures. The residential handler assessment quantitatively evaluated inhalation exposure from hose end sprayer for turf applications but not dermal exposure as no dermal point of departure was identified. There is the potential for short-term post-application exposure for individuals exposed as a result of being in an environment that has been previously treated with fosetyl-Al (based on contact with treated turf at the maximum turf application rate of 17.6 pounds (lbs) active ingredient/Acre (ai/A)). Incidental oral post-application exposure is quantitatively assessed for children 1 to <2 years old for exposure to treated turf. Dermal post-application exposure was not assessed because no dermal hazard was identified. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.

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.”

Although fosetyl-Al shares a similar chemical structure with many organophosphates (OPs), there is no evidence of neurotoxicity or evidence of cholinesterase inhibition following exposure to fosetyl-Al at dose levels at and greater than the limit dose. EPA has concluded that fosetyl-Al is a not member of the OP cumulative group. EPA has not found fosetyl-Al to share a common mechanism of toxicity with any other substances either, and fosetyl-Al does not appear to produce a toxic metabolite produced by any other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fosetyl-Al 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 Food Quality Protection Act Safety Factor (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. There is no evidence of increased susceptibility following in utero exposure to fosetyl-Al in either the rat (at dose levels that do not exceed the limit dose) or rabbit developmental toxicity study, and there is no evidence of increased susceptibility following in utero and/or pre-/postnatal exposure in the 3-generation reproduction study in rats.

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 fosetyl-Al is complete.

ii. There is no indication that fosetyl-Al is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that fosetyl-Al results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 3-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the water modeling used to assess exposure to fosetyl-Al in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fosetyl-Al.

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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, fosetyl-Al is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fosetyl-Al from food and water will utilize 12% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fosetyl-Al is not expected.

3. Short-term risk. Fosetyl-Al is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to fosetyl-Al.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 3,200 for adult residential handlers applying liquid concentrates to turf via hose-end sprayer and for children, 540 for children's incidental oral post-application exposure from contacting treated lawns. Because EPA's level of concern for fosetyl-Al is an MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Because no intermediate-term non-occupational exposures are expected, fosetyl-Al is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A, fosetyl-Al is not expected to pose a cancer risk to humans.

6. 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 fosetyl-Al residues.

Rhone-Poulenc Method No. AR 154-97 underwent successfully independent laboratory validation for use as an enforcement analytical method. Although the tolerance expression includes only parent fosetyl-Al, Method AR 154-97 was validated for both fosetyl-Al and its metabolite, phosphorous acid.

In support of the pepper trials, the registrant made use of a data collection method, Method No. 00861/M001, which achieved a lower Limit of Quantitation (LOQ) than Method AR 154-97. Method No. 00861/M001 is an HPLC-MS/MS (high performance liquid chromatography-tandem mass spectrometry) method that uses the same extraction solvent as Method AR 154-97. Sufficient method validation data were submitted with the field trial data to support a LOQ of 0.01 ppm for fosetyl-Al residues in pepper (bell and non-bell). As EPA encourages the development of improved analytical methods and because both methods use the same extraction solvent, EPA considers Method No. 00861/M001 to also be a suitable enforcement method for peppers. Thus, both 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 not established a MRL for fosetyl-Al.

The Agency received a comment expressing concerns about allowing residues of pesticides on eggplant and peppers. The Agency understands the commenter's concerns and recognizes that some individuals believe that no residue of pesticides should be allowed because of potential effects. However, under the existing legal framework provided by FFDCA section 408, EPA is authorized to establish pesticide tolerances where persons seeking such tolerances have demonstrated that the pesticide meets the safety standard imposed by the statute. Based on its assessment of the available data, the Agency has concluded there is a reasonable certainty that no harm will result from aggregate exposure to residues of fosetyl-Al.

EPA is not establishing a separate tolerance for residues of fosetyl-Al in or on pepper, non-bell (chili), dry fruit. The residues found on the dried commodity will be covered by the tolerance for residues of fosetyl-Al in or on pepper/eggplant, subgroup 8-10B; therefore, no separate tolerance is needed.

Therefore, tolerances are established for residues of fosetyl-Al, aluminum tris ( O -ethylphosphonate), in or on pepper/eggplant, subgroup 8-10B at 0.01 ppm.

This action 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 action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action 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 action 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) (2 U.S.C. 1501 et seq. ).

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) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

Table of Contents I. Background II. Nissan's Petition for Reconsideration to the July 29, 2011 Final Rule III. Agency Response to Nissan's Petition for Reconsideration IV. Technical Corrections to the July 29, 2011 Final Rule a. Omitted Voltage Definitions b. Clarification to Volts of Alternating Current (VAC) Definition c. Other Typographical Corrections to the Regulatory Text V. Rulemaking Analyses and Notices VI. Regulatory Text I. Background

On June 14, 2010, 1 NHTSA issued a final rule amending the electrical shock protection requirements of Federal Motor Vehicle Safety Standard (FMVSS) No. 305, “Electric-powered vehicles; electrolyte spillage and electrical shock protection.”  2 In that document, the agency changed the requirements in FMVSS No. 305 to add flexibility for manufacturers of electric vehicles (and other vehicles with high voltage components such as fuel cell vehicles) while still maintaining protection for vehicle occupants and first responders from electrical shock. The main changes to the standard included creating two alternative compliance options ( i.e., the electrical isolation  3 and low-voltage  4 options) and altering the requirements to recognize the difference between alternating current (AC) and direct current (DC) high voltage sources. In addition, the 2010 final rule included new definitions and made various updates to existing definitions to align the standard more closely with voluntary industry practice.

Subsequent to the 2010 final rule, the agency received various petitions for reconsideration from vehicle manufacturers and their trade associations. Many of the petitioners sought increased clarity of the definitions, test specifications, and performance requirements of the rule. The agency published a final rule responding to those petitions on July 29, 2011. 5 The main changes to the 2010 final rule were clarifications to the following:

(1) The scope, applicability, and the definitions in the standard,

(2) the retention requirements for electric energy storage/conversion systems,

(3) the electrical isolation requirements,

(4) test specifications and requirements for electrical isolation monitoring, and

(5) the state-of-charge of electric energy storage devices prior to crash tests.

In addition to the above clarifications to the requirements and test procedures of the standard, that response to petitions for reconsideration also denied requests that the agency reconsider certain requests from the petitioners. Those requests included implementing a protective barrier compliance option for electrical safety, adjusting the test procedure to allow for alternative gas for crash testing hydrogen fuel cell vehicles, and adopting a low-energy compliance option for electrical safety. In response to those requests, the agency reiterated its positions on those matters from the 2010 final rule. We cited the lack of data to support the petitioners' requests to implement these changes to the standard. We also noted that no significant new research had produced any data that would have enabled the agency to arrive at a different conclusion from the 2010 final rule. In addition, we again expressed concerns in the 2010 final rule that some of these recommendations (such as using inert gas and megohmmeters for testing) might be outside the scope of the rulemaking.

Subsequent to the 2011 final rule responding to petitions for reconsideration, the agency received a further petition for reconsideration. The petition (from Nissan) requested that we amend section S7.6 of FMVSS No. 305 to allow the use of a megohmmeter as an alternative measurement method for the electrical isolation test procedure. 6 Nissan suggested using a megohmmeter to measure the isolation resistance directly, rather than measuring voltage and calculating resistance (as presently specified in FMVSS No. 305). They contend that this results in a more stable and accurate post-crash test measurement procedure. Nissan noted that the test procedures for United Nations Economic Commission for Europe (ECE) Regulation No. 94 allow such a measurement method. 7 In addition to enhanced measurement stability and accuracy, Nissan stated that a direct resistance measurement supports the use of an inert gas and inactive fuel cells in crash tests of fuel cell vehicles. Nissan expressed concern that the electrical isolation test procedure specified in FMVSS No. 305 S7.6 does not permit the use of inert gas and inactive fuel cells in crash tests because the procedure only specifies a voltage measurement method. Nissan asked the agency to expedite ongoing research to develop a test procedure for evaluating electrical safety of fuel cell vehicles with inert gas and inactive fuel cells.

As stated above, the agency has addressed the issue of including test procedures in FMVSS No. 305 for evaluating electrical isolation resistance that use a megohmmeter and an inert gas (first in the June 14, 2010 final rule and second in the July 29, 2011 final rule responding to petitions for reconsideration). In this final rule, our position on the matter has not substantively changed. We continue to be concerned that incorporating an alternative test procedure that incorporates a megohmmeter and inert gas would exceed the scope of this rulemaking.

The 2010 final rule did not provide alternative test procedures with these characteristics because the agency's research was ongoing, there was insufficient information to make any regulatory decisions on establishing these alternative test procedures, and the agency was concerned that this issue would be outside the scope of the rulemaking. In dealing with the same issue in the 2011 final rule, the agency stated that its position on the issue had not substantively changed since the 2010 final rule and that no new information was available to lead it to conclude otherwise. As with the 2010 final rule, we noted in the 2011 final rule that the agency was continuing its research to determine the feasibility for establishing alternative test procedures that would incorporate the use of a megohmmeter and inert gas.

Since publication of the 2011 final rule (and the petition for reconsideration of the 2011 final rule from Nissan), the agency has completed additional research on the feasibility of using a megohmmeter for measuring electrical isolation. 8 The research presents certain technical questions that need to be resolved ( i.e., the research showed that megohmmeters could accurately measure electrical isolation resistance of DC high voltage sources in an inactive state but did not consistently do so for AC high voltage sources). We believe that the most appropriate forum to pursue these issues would be a subsequent rulemaking action that includes a new proposal. To incorporate a new set of procedures to test electrical isolation using the method suggested by Nissan in this document would likely raise concerns about the scope of the rulemaking and the effectiveness of the public's opportunity to comment on the merits of incorporating such procedures.

As discussed in the July 29, 2011 final rule, some international regulations and international standards permit the use of megohmmeters in crash tests of hydrogen powered vehicles. We believe that closer harmonization with international regulations (to the extent that they meet the need for safety and the other requirements of the Motor Vehicle Safety Act  9 ) is an important consideration. However, as already noted in this document, this issue would be more appropriate for consideration in a subsequent rulemaking action. In that context, the agency would seek to propose a resolution for these technical issues that we have discovered through our research and obtain further input from the public on that approach. This process would help ensure that any such test procedure would be able to evaluate the vehicle's electrical safety using an inert gas and a megohmmeter in a clear, objective, and repeatable fashion.

Thus, the agency cannot grant (within this rulemaking) the petitioner's request to reconsider our decision not to incorporate a test procedure in FMVSS No. 305 for evaluating electrical isolation resistance using a megohmmeter and inert gas. However, as we noted in the July 29, 2011 final rule, manufacturers are not prohibited from using alternative test procedures and devices other than those in the FMVSSs as a basis for their compliance certification.

In addition to addressing the petition for reconsideration from Nissan, this document makes a few technical amendments to the regulatory text of FMVSS No. 305 to correct omissions, add clarity, and correct typographical errors. Due to the clerical nature of these corrections to the 2011 final rule, we find that there is good cause to determine that notice and comment on these corrections is unnecessary under the Administrative Procedure Act. 10

The three definitions for voltage of alternating current (VAC), voltage of direct current (VDC), and working voltage were included in paragraph S4 of the June 14, 2010 final rule but were inadvertently omitted in the July 29, 2011 final rule. This final rule restores these definitions in paragraph S4 of FMVSS No. 305 without any changes to the language from the 2010 final rule (except for a clarification to the definition of VAC, as will be discussed in the section that follows). We find that notice and comment is unnecessary for restoring these three definitions in paragraph S4 of FMVSS No. 305. It was clear that the omission of these definitions was a clerical mistake as the amended regulatory text from the 2011 final rule continued to use the terms VAC, VDC, and working voltage in the requirements and test procedures in the standard. Further, we did not mention removing the definitions from paragraph S4 in the preamble to the 2011 final rule and we believe that restoring these three definitions does not change the substantive requirements of FMVSS No. 305.

In addition to restoring the VAC definition into paragraph S4, we believe it is appropriate to further clarify the definition of VAC to be aligned with industry practices and other standardized definitions. Subsequent to the 2011 final rule, the agency received questions from the Alliance of Automobile Manufacturers (“the Alliance”)  11 seeking confirmation that NHTSA intended to use the standard industry practice of using the root mean square value of voltage for VAC.

While we have expressed (throughout the rulemaking process) voltage of alternating current using the root meet square value, we agree with the Alliance that this definition could be clarified. In the 2010 final rule, the definition of VAC stated that “ VAC means volts of alternating current (AC).” Due to the nature of alternating current, VAC varies in time and it could potentially be measured using a different method. However, our rulemaking process has always used the root mean square value for expressing VAC because the safety thresholds established by the 2010 final rule were based on limits of electrical current (that the body can withstand) from IEC Technical Specification 60479-1. This technical specification expresses electrical current for AC sources as the root mean square value of current. 12 As our safety thresholds for AC sources are based on electrical current limits expressed as the root mean square value of current, the voltage for AC sources must also be expressed using the root mean square value. 13

We further expressed VAC as the root mean square value of voltage of AC sources because this is the standard definition used in common industry standards. The root mean square value is the square root of the time average value of the square of the voltage within a period of oscillation. Using this method of expressing AC voltage is common practice for a wide variety of industries. The Society of Automotive Engineers (SAE) Recommended Practice J1772, 14 refers to the voltage of AC mains as the root mean square value. The voltage of power typically supplied to homes (commonly referred to as “120 Volts”) is the root mean square value of the AC supply. Voltage of electric power transmission lines are also reported as the root mean square value of voltage. Instrumentation devices, such as multimeters and voltmeters, also measure the root mean square value of voltage of alternating current sources.

Therefore, we find that notice and comment is unnecessary for this clarification to the definition of VAC. The agency is simply stating that VAC is expressed as the root mean square value of voltage in the VAC definition in FMVSS No. 305 to make clear a term that has always been expressed in this manner throughout the rulemaking process. We believe that this clarification does not substantively change the requirements of FMVSS No. 305. Further, the clarification does not change the industry understanding of VAC as used in the standard (as evidenced by the questions we received from industry on this matter).

In addition, the agency discovered various typographical errors resulting from the 2011 final rule that we are now correcting in this final rule. We find that notice and comment is unnecessary for these changes to FMVSS No. 305. These changes do not alter the substance of the rule. Instead, they correct various inconsistencies including incorrect paragraph references, incomplete sentences, and updating a reference to a current definition (as opposed to an old definition that has been removed from FMVSS No. 305).

In paragraph S5.4, this final rule corrects a reference dealing with electrical isolation monitoring requirements. Paragraph S5.4 establishes the requirements that an electrical isolation monitoring system must meet. Electrical isolation monitoring is required under paragraph S5.3(a)(3) when the electrical isolation of a DC high voltage source is greater or equal to 100 ohms/volt (as opposed to 500 ohms/volt without an electrical isolation monitoring system). S5.4 references S5.3 to indicate the situations under which electrical isolation monitoring is required. However, the current S5.4 incorrectly refers to S5.3(a)(2), a section applicable to DC high voltage sources without electrical isolation monitoring. Thus, the agency is correcting this reference to S5.3(a)(3) which is applicable to DC high voltage sources with electrical isolation monitoring. We believe that this change corrects a clear typographical error.

In addition, this final rule rewords S7.6.4 and S7.6.5 to clarify the language in these paragraphs. The 2011 final rule mistakenly edited paragraphs S7.6.4 and S7.6.5 to include incomplete sentences and the term “voltage(s)” when each paragraph only referenced one voltage measurement. In FMVSS No. 305, S7.6.4 states that the voltage(s) is/are measured as shown in Figure 2. It also has an incomplete sentence about the voltages(s) (V1) between the negative side of the high voltage source and the electrical chassis. Paragraph S7.6.5 states that the voltage(s) is/are measured as shown in Figure 3. It also has an incomplete sentence about the voltage(s) (V2) between the positive side of the high voltage source and the electrical chassis.

Since only a single voltage measurement is made in each of these sections, the references to “voltage(s)” are incorrect and confusing. Further, we have edited the paragraphs to remove the sentence fragments from each paragraph. Therefore, the agency is rewording S7.6.4 and S7.6.5 in this final rule. Paragraph S7.6.4 will state that the voltage V1 between the negative side of the high voltage source and the electrical chassis is measured as shown in Figure 2. Further, paragraph S7.6.5 will state that the voltage V2 between the positive side of the high voltage source and the electrical chassis is measured as shown in Figure 3.

As stated above, these changes correct grammatical errors for these two paragraphs without changing the substance of the requirements or the measurement procedures. These sentences merely restate the measurement procedure shown in Figure 2 and Figure 3 more clearly than the language adopted by the 2011 final rule.

Further, this final rule changes the phrase, “electrical isolation measurement,” to “voltage measurement,” in two instances of section S7.7 Voltage measurement. As evident from the other portions of the regulatory text, the measurements obtained in S7.7 are not “electrical isolation measurements” but are “voltage measurements.” The title of S7.7 is “voltage measurement,” suggesting that the measured value in S7.7 is the voltage. Paragraph S7.6 uses the voltage measurements to then calculate the electrical isolation resistance of a high voltage source. Further, “electrical isolation” is defined in the current standard as the resistance between any high voltage source and any of the vehicle's electrical chassis divided by the working voltage of the high voltage source. This measurement cannot be obtained through the procedure described in S7.7. Therefore, it is clear that the reference to “electrical isolation measurements” is a typographical error. Thus, this final rule changes the references to “electrical isolation measurements” to “voltage measurements” in order to clarify that the voltages are measured and the electrical isolation is computed from the voltage measurements. This is not a substantive change to the standard.

Finally, this final rule makes two minor clarifications to paragraph S8. First we are italicizing the title “Test procedure for on-board electrical isolation monitoring system” to clarify that it is a title. Second, we are revising the term “high voltage system to the propulsion motor(s)” in S8 subparagraph (2) to “electric energy storage/conversion system to the propulsion system.” This is also a typographical error because the terms “high voltage system” and “propulsion motor” are definitions that were replaced by “electric energy storage/conversion system” and “propulsion system” in the 2011 final rule. Thus, the terms “high voltage system” and “propulsion motor” are not defined in FMVSS No. 305 and it should be clear that the agency intended to use the updated definitions for paragraph S8 in the 2011 final rule. Thus, we are updating these terms in paragraph S8 and we do not believe that this is a substantive change to the standard.

NHTSA has considered the impact of this rulemaking action under Executive Order 12866, Executive Order 13563, and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed by the Office of Management and Budget under E.O. 12866, “Regulatory Planning and Review.” It is not considered to be significant under E.O. 12866 or the Department's Regulatory Policies and Procedures (44 FR 11034; February 26, 1979). NHTSA has determined that the effects of this final rule are minor and that a regulatory evaluation is not needed to support the subject rulemaking. This final rule only makes slight changes to the regulatory text of the July 29, 2011 final rule to add clarification and does not impose significant costs beyond those already required by the July 29, 2011 final rule.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a notice of proposed rulemaking or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small governmental jurisdictions). No regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities.

NHTSA has considered the effects of this final rule under the Regulatory Flexibility Act. I certify that this final rule does not have a significant economic impact on a substantial number of small entities. Any small manufacturers that might be affected by this final rule are already subject to the requirements of FMVSS No. 305.

NHTSA has examined this final rule pursuant to Executive Order 13132 (64 FR 43255; Aug. 10, 1999) and concluded that no additional consultation with States, local governments, or their representatives is mandated beyond the rulemaking process. The agency has concluded that the final rule does not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The final rule does not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule does not impose substantial additional requirements. Instead, it clarifies the existing requirements from the July 29, 2011 final rule.

NHTSA rules can have preemptive effect in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an expressed preemption provision that states when a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter. 49 U.S.C. 30103(b)(1). It is this statutory command that preempts any non-identical State legislative and administrative law  15 addressing the same aspect of performance, not this rulemaking.

The express preemption provision described above is subject to a savings clause under which “[c]ompliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person from liability at common law.” 49 U.S.C. 30103(e). Pursuant to this provision, State common law tort causes of action against motor vehicle manufacturers that might otherwise be preempted by the express preemption provision are generally preserved. However, the Supreme Court has recognized the possibility, in some instances, of implied preemption of State common law tort causes of action by virtue of NHTSA's rules—even if not expressly preempted.

This second way that NHTSA rules can preempt is dependent upon the existence of an actual conflict between an FMVSS and the higher standard that would effectively be imposed on motor vehicle manufacturers if someone obtained a State common law tort judgment against the manufacturer—notwithstanding the manufacturer's compliance with the NHTSA standard. Because most NHTSA standards established by an FMVSS are minimum standards, a State common law tort cause of action that seeks to impose a higher standard on motor vehicle manufacturers will generally not be preempted. However, if and when such a conflict does exist—for example, when the standard at issue is both a minimum and a maximum standard—the State common law tort cause of action is impliedly preempted. See Geier v. American Honda Motor Co., 529 U.S. 861 (2000).

Pursuant to Executive Order 13132, NHTSA has considered whether this rule could or should preempt State common law causes of action. The agency's ability to announce its conclusion regarding the preemptive effect of one of its rules reduces the likelihood that preemption will be an issue in any subsequent tort litigation.

To this end, the agency has examined the nature ( e.g., the language and structure of the regulatory text) and objectives of this rule and finds that this rule merely clarifies the requirements and definitions contained in the July 29, 2011 final rule. Thus, NHTSA does not intend that this rule preempt state tort law that would effectively impose a higher standard on motor vehicle manufacturers than that established by this rule. Additionally, in the July 29, 2011 final rule, the agency did not assert preemption. Establishment of a higher standard by means of State tort law would not conflict with the final rule announced here. Without any conflict, there could not be any implied preemption of a State common law tort cause of action.

NHTSA has analyzed this rulemaking action for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action will not have any significant impact on the quality of the human environment.

When promulgating a regulation, agencies are required under Executive Order 12988 to make every reasonable effort to ensure that the regulation, as appropriate: (1) Specifies in clear language the preemptive effect; (2) specifies in clear language the effect on existing Federal law or regulation, including all provisions repealed, circumscribed, displaced, impaired, or modified; (3) provides a clear legal standard for affected conduct rather than a general standard, while promoting simplification and burden reduction; (4) specifies in clear language the retroactive effect; (5) specifies whether administrative proceedings are to be required before parties may file suit in court; (6) explicitly or implicitly defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship of regulations.

Pursuant to this Order, NHTSA notes as follows. The preemptive effect of this final rule is discussed above. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceeding before they may file suit in court.

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

Under the Paperwork Reduction Act of 1995 (PRA), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. There are no information collection requirements associated with this final rule.

Under the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as the Society of Automotive Engineers (SAE). The NTTAA directs us to provide Congress, through OMB, explanations when we decide not to use available and applicable voluntary consensus standards. FMVSS No. 305 has historically drawn largely from SAE J1766. Prior to this update, FMVSS No. 305 was based on the April 2005 version of SAE J1766. However, this final rule has made certain amendments to the standard to reflect the development of new voluntary consensus standards that have superseded SAE J1766. Thus, this final rule makes revisions to the June 14, 2010 final rule that updated FMVSS No. 305.

The Unfunded Mandates Reform Act of 1995 requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or Tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). This final rule, which clarifies the July 29, 2011 final rule, will not result in expenditures by State, local or Tribal governments, in the aggregate, or by the private sector in excess of $100 million annually.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

In consideration of the foregoing, NHTSA amends 49 CFR part 571 as follows:

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.

The A season allowance of the 2015 Pacific cod total allowable catch (TAC) apportioned to catcher/processors using trawl gear in the Central Regulatory Area of the GOA is 903 metric tons (mt), as established by the final 2014 and 2015 harvest specifications for groundfish of the GOA (79 FR 12890, March 6, 2014) and inseason adjustment to the final 2015 harvest specifications for Pacific cod (80 FR 192, January 5, 2015).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2015 Pacific cod TAC apportioned to catcher/processors using trawl gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, pursuant to § 679.20(d)(1)(ii)(B), the Regional Administrator is establishing a directed fishing allowance of 0 mt and is setting aside the remaining 903 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 12, 2015.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.