Federal Register Vol. 81, No.47,

This proposed rule is issued under Marketing Order No. 925, as amended (7 CFR part 925), regulating the handling of grapes grown in a designated area of southeastern California. The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 13175.

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, grape handlers in a designated area of southeastern California are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable grapes beginning on January 1, 2016, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This proposed rule would increase the assessment rate established for the Committee for the 2016 and subsequent fiscal periods from $0.0250 to $0.0300 per 18-pound lug of grapes handled.

The grape order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of grapes grown in a designated area of southeastern California. They are familiar with the Committee's needs and with the costs of goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2015 and subsequent fiscal periods, the Committee recommended, and the USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA based upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on November 12, 2015, and unanimously recommended 2016 expenditures of $143,500, a contingency reserve fund of $6,500, and an assessment rate of $0.0300 per 18-pound lug of grapes handled. In comparison, last year's budgeted expenditures were $135,500. The Committee recommended a crop estimate of 5,000,000 18-pound lugs, which is lower than the 5,800,000 18-pound lugs handled last year. The Committee also recommended carrying over a financial reserve of $47,500, which would increase to $54,000 if the contingency fund is not expended. The assessment rate of $0.0300 per 18-pound lug of grapes handled recommended by the Committee is $0.0050 higher than the $0.0250 rate currently in effect. The higher assessment rate, applied to shipments of 5,000,000 18-pound lugs, would generate $150,000 in revenue and be sufficient to cover anticipated expenses.

The major expenditures recommended by the Committee for the 2016 fiscal period include $28,500 for research, $20,080 for office expenses, $56,500 for management and compliance expenses, $25,000 for consultation services, and $6,500 for a contingency reserve. The $28,500 research project is a continuation of a vine study in progress by the University of California, Riverside. In comparison, major expenditures for the 2015 fiscal period included $15,500 for research, $17,000 for general office expenses, $62,750 for management and compliance expenses, $25,000 for consultation services, and $9,500 for a contingency reserve. Overall 2016 expenditures include a decrease in management and compliance expenses, and increases in office expenses, and research expenses.

The assessment rate recommended by the Committee was derived by evaluating several factors, including estimated shipments for the 2016 season, budgeted expenses, and the level of available financial reserves. The Committee determined that the $0.0300 assessment rate would generate $150,000 in revenue to cover the budgeted expenses of $143,500, and a contingency reserve fund of $6,500.

Reserve funds by the end of 2016 are projected to be $47,500 if the $6,500 added to the contingency fund is expended or $54,000 if it is not expended. Both amounts are well within the amount authorized under the order. Section 925.41 of the order permits the Committee to maintain approximately one fiscal period's expenses in reserve.

The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by USDA based upon a recommendation and information submitted by the Committee or other available information.

Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate the Committee's recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2016 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 13 handlers of southeastern California grapes who are subject to regulation under the marketing order and about 41 grape producers in the production area. Small agricultural service firms are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those whose annual receipts are less than $750,000. Ten of the 13 handlers subject to regulation have annual grape sales of less than $7,500,000, according to USDA Market News Service and Committee data. In addition, information from the Committee and USDA's Market News indicates that at least 10 of 41 producers have annual receipts of less than $750,000. Thus, it may be concluded that a majority of the grape handlers regulated under the order and about 10 of the producers could be classified as small entities under the Small Business Administration's definitions.

This proposed rule would increase the assessment rate established for the Committee and collected from handlers for the 2016 and subsequent fiscal periods from $0.0250 to $0.0300 per 18-pound lug of grapes. The Committee unanimously recommended 2016 expenditures of $143,500, a contingency reserve fund of $6,500, and an assessment rate of $0.0300 per 18-pound lug of grapes handled. The proposed assessment rate of $0.0300 is $0.0050 higher than the 2015 rate currently in effect. The quantity of assessable grapes for the 2016 season is estimated at 5,000,000 18-pound lugs. Thus, the $0.0300 rate should generate $150,000 in income. In addition, reserve funds at the end of the year are projected to be $54,000, which is well within the order's limitation of approximately one fiscal period's expenses.

The major expenditures recommended by the Committee for the 2016 fiscal period include $28,500 for research, $20,080 for general office expenses, $56,500 for management and compliance expenses, $25,000 for consultation services and $6,500 for the contingency reserve. In comparison, major expenditures for the 2015 fiscal period included $15,500 for research, $17,000 for general office expenses, $62,750 for management and compliance expenses, $25,000 for consultation services, and $9,500 for a contingency reserve. Overall 2016 expenditures include a decrease in management and compliance expenses, and increases in general office expenses, and research expenses.

Prior to arriving at this budget, the Committee considered alternative expenditures and assessment rates, to include not increasing the $0.0250 assessment rate currently in effect. Based on a crop estimate of 5,000,000 18-pound lugs, the Committee ultimately determined that increasing the assessment rate to $0.0300 would generate sufficient funds to cover budgeted expenses. Reserve funds at the end of the 2016 fiscal period are projected to be $47,500 if the $6,500 contingency fund is expended or $54,000 if it is not expended. These amounts are well within the amount authorized under the order.

A review of historical crop and price information, as well as preliminary information pertaining to the upcoming fiscal period, indicates that the shipping point price for the 2015 season averaged about $22.75 per 18-pound lug of California desert grapes handled. If the 2016 price is similar to the 2015 price, estimated assessment revenue as a percentage of total estimated handler revenue would be 0.13 percent for the 2016 season ($0.0300 divided by $22.75 per 18-pound lug).

This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. However, these costs would be offset by the benefits derived from the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the grape production area and all interested persons were invited to attend and participate in Committee deliberations on all issues. Like all Committee meetings, the November 12, 2015, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0189. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large California grape handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Antoinette Carter at the previously-mentioned address in the FOR FURTHER INFORMATION CONTACT section.

A 15-day comment period is provided to allow interested persons to respond to this proposed rule. Fifteen days is deemed appropriate because: (1) The 2016 fiscal period begins on January 1, 2016, and the order requires that the rate of assessment for each fiscal period apply to all assessable grapes handled during such fiscal period; (2) the Committee needs to have sufficient funds to pay its expenses, which are incurred on a continuous basis; and (3) handlers are aware of this action, which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years.

For the reasons set forth in the preamble, 7 CFR part 925 is proposed to be amended as follows:

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.), as amended, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Section 513(a) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act). Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the issue of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act). Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).

FDA refers to devices that were in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), as “preamendments devices.” Under section 513(d)(1) of the FD&C Act, FDA classifies these devices after FDA: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

A person may market a preamendments device that has been classified into class III and devices found to be substantially equivalent by means of premarket notification procedures (510(k)) to such a preamendments device or to a device within that type without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.

FDA refers to devices that were not in commercial distribution prior to May 28, 1976 as “postamendments devices.” These devices are automatically classified by statute (section 513(f) of the FD&C Act) into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).

The regulatory history of posterior cervical screw systems arose from that of pedicle screw spinal systems, which are medical devices similar in design and principle of operation, but differ based on anatomic use in the spine and their indications for use. Both device systems are comprised of various interconnecting components such as longitudinal members (i.e., rods, plates) and screws that are configured per the patient's anatomy and implanted into the posterior spine to provide stabilization as bony fusion occurs. After the enactment of the Medical Device Amendments of 1976, FDA commenced to identify and classify all preamendments devices, in accordance with section 513(b) of the FD&C Act. In the Federal Register of September 4, 1987 (52 FR 33686), FDA classified a total of 77 generic types of orthopedic devices. Neither pedicle screw spinal systems nor posterior cervical screw systems were identified in this initial effort.

In July 1998, FDA issued a final rule (63 FR 40025, July 27, 1998) classifying pedicle screw spinal systems as class II devices, and a technical amendment to this rule was published on May 22, 2001 (66 FR 28051). In the technical amendment, FDA noted that pedicle screw systems for the following intended uses in the cervical spine (which are now referred to as posterior cervical screw systems) were in use prior to May 28,1976 and are therefore considered preamendments devices: (1) Cervical spondylolisthesis (all grades and types); (2) cervical spondylolysis; (3) cervical degenerative disc disease; (4) degeneration of the cervical facets accompanied by instability; (5) cervical trauma (fracture and dislocation); and (6) revision of failed previous fusion surgery (pseudarthrosis) of the cervical spine. Since 2001, FDA has regulated posterior cervical screw systems as unclassified preamendments devices requiring premarket notification (510(k)). Posterior cervical screw systems currently on the market have been determined to be substantially equivalent to devices that were in commercial distribution prior to May 28, 1976.

On April 9, 2009, FDA published an order under sections 515(i) and 519 of the FD&C Act (515(i) order) for the submission of safety and effective information on pedicle screw spinal systems with certain indications for use (74 FR 16214). In response to that order, FDA received a request from the Orthopedic Surgical Manufacturers Association (OSMA) to classify posterior cervical screw systems into class II (special controls). Because this request was considered to be outside the scope of the 515(i) order related to pedicle screw spinal systems, FDA requested that OSMA submit a separate petition for classification of posterior cervical screw systems. OSMA submitted the requested petition on November 22, 2011, under Docket No. FDA-2011-P-0851-0001/CCP (Ref. 1). FDA consulted with the Orthopaedic and Rehabilitation Devices Panel (the Panel), an FDA advisory committee, regarding the classification of this device type on September 21, 2012 (Ref. 2). At the Panel meeting, the Panel recommended that posterior cervical screw systems be classified as class II with special controls.

During a public meeting held on September 21, 2012, the Panel made recommendations regarding the classification and regulatory controls for posterior cervical screw systems.

FDA is proposing the following identification for posterior cervical screw systems based on the Panel's recommendations and the Agency's review. Posterior cervical screw systems utilizing pedicle and lateral mass screws, implanted from the C1 to C7 levels, are multiple component devices, made from a variety of materials, including metallic alloys. Posterior cervical instrumentation generally involves use of a fixation system comprised of both longitudinal members and screws that can span various combinations of spinal levels from the occiput to the upper thoracic spine. Cervical lateral mass and pedicle screws serve as the primary bone anchor points and require selection based on individual patient anatomy, as determined by preoperative cross-sectional imaging. Posterior cervical screw systems consist of a bone anchor via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods) and optional transverse connectors. An interconnection mechanism (e.g., offset connector, nuts, screws, or bolts) may be utilized to link the anchor and longitudinal member. These posterior cervical screw systems are statically fixed devices, only intended to be used as an adjunct to fusion and do not include any dynamic features, which may include, but are not limited to: Non-uniform and/or non-metallic longitudinal elements, features that allow more motion or flexibility compared to traditional rigid systems, or features that do not provide the system immediate rigid fixation.

The Panel recommended that posterior cervical screw systems be classified into class II (special controls).

The Panel considered the panel members' personal knowledge of and clinical experience with the device type, as well as the history of safety and effectiveness of the device over many years of clinical use. The Panel recommended that posterior cervical screw systems be classified into class II as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine and craniocervical junction: (1) Traumatic spinal fractures and/or traumatic dislocations; instability or deformity; (2) failed previous fusions (e.g., pseudarthrosis); (3) tumors involving the cervical spine; and (4) degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Panel also found that there is reasonable evidence to support use of posterior cervical screws as an adjunct to fusion in the pediatric population. In addition, there was panel consensus supporting the use of posterior cervical screws for non-fusion treatment for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion; the Panel emphasized that their discussions were limited to this narrow patient population and should not be extrapolated to other non-fusion applications or technologies (e.g., dynamic stabilization systems).

The Panel also recommended that posterior cervical screw systems be classified into class II because special controls, together with general controls, would provide reasonable assurance of their safety and effectiveness. The risks to health for this device type are known and can be adequately mitigated by special controls (such as mechanical testing, biocompatibility, and labeling).

Based on the Panel's discussion and recommendations in addition to comprehensive literature reviews and analyses by OSMA and FDA, the risks to health associated with posterior cervical screw systems and the proposed measures to mitigate these risks are identified in the following list and in table 1. The identified risks to health are identical to those proposed by FDA during the September 21, 2012, panel meeting, with the addition of risks associated with the presence of vertebral arteries, as recommended by FDA with panel agreement. FDA determined that the following risks to health are associated with its use:

• Device failure—Components may deform, fracture, wear, loosen, or disassemble, resulting in a mechanical or functional failure.

• Failure at the bone/implant interface—Components may loosen or disengage from the bone.

• Tissue injury—Intraoperative and postoperative risks of tissue injury include: Bone fracture, injury to blood vessels or viscera, neurologic injury, dural tear or cerebrospinal fluid leak, skin penetration or irritation, and postoperative wound problems, including infection, hematoma/seroma.

• Adverse tissue reactions—Adverse tissue reactions include: Foreign body response, metal allergy, and metal toxicity.

• Device malposition—Risks of device malposition may include difficulty or inability to implant the device components or incorrect placement of the device.

• Pseudarthrosis—The risk of nonunion, or pseudarthrosis, signifies failure of bony fusion and potential instability or pain.

• Adverse clinical sequelae—Adverse clinical sequelae may include the risk of new or unresolved neck pain, new or worsened neurologic deficit/injury, or loss of correction.

The risks to health presented to the 2012 Panel such as cardiac, respiratory, and death are considered general surgical risks associated with the surgical procedure to implant posterior cervical screw systems; these risks are not directly associated with posterior cervical screw systems and therefore are not included in the previous list of risks. Failure of the posterior cervical screw system as a result of the risks to health listed may result in the need for reoperation, revision, or removal.

While presented to the Panel as a potential risk, graft settling would not be considered a device-specific risk. Rather, it represents a potential mechanism for the development of pseudarthrosis, instability, or lack of correction. Further, graft settling is expected in patients undergoing fusion surgery and does not necessarily result in adverse clinical sequelae. Thus this item does not specifically appear in the previous list.

FDA believes that the following special controls, in addition to general controls, are sufficient to mitigate the risks to health described in section II.D. and provide reasonable assurance of safety and effectiveness of the device.

• Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.

• Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.

• Device must be demonstrated to be biocompatible.

• Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.

• Labeling must bear all information required for the safe and effective use of the device, specifically including the following:

○ Clear description of the technological features of the device, including identification of device materials and the principles of device operation;

○ intended use and indications for use including levels of fixation;

○ device-specific warnings, precautions, and contraindications that include the following statements:

“Precaution: Pre-operative planning prior to implantation of posterior cervical lateral mass and pedicle screw spinal systems should include review of cross-sectional imaging studies (e.g., CT and/or MRI imaging) to evaluate the patient's cervical anatomy including the transverse foramen and the course of the vertebral arteries. If any findings would compromise the placement of lateral mass or pedicle screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”

“Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”

○ identification of magnetic resonance (MR) compatibility status;

○ cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and

○ detailed instructions of each surgical step, including device removal, accompanied by magnified illustrations.

Table 1 summarizes the risks to health described in section II.D. and the proposed special controls that are sufficient to mitigate these risks.

On February 3, 2016, HUD published an advanced notice of proposed rulemaking, 81 FR 5679, February 3, 2016, seeking input from the public on many issues, including questions presented in this notice, including how HUD can structure policies to reduce the number of individuals and families in public housing whose incomes significantly exceed the income limit and have significantly exceeded the income limit for a sustained period of time after initial admission. In response to several requests, HUD is reopening the comment period for another 30 days.

The potential misuse of foreign financial accounts to evade domestic criminal, tax, and regulatory laws has been a long-held congressional concern. The House report on the bill leading to the enactment of the BSA described the use of undisclosed foreign financial accounts for a wide range of abuses.1 More than four decades after the BSA's enactment, foreign financial accounts can still be used for many of the abuses Congress catalogued when it passed the BSA, and transparency with respect to the foreign accounts of U.S. persons continues to aid law enforcement and deter illicit use.

The BSA, Titles I and II of Public Law 91-508, as amended, codified at 12 U.S.C. 1829b, 12 U.S.C. 1951-1959, and 31 U.S.C. 5311-5314 and 5316-5332, authorizes the Secretary of the Treasury (“Secretary”), among other things, to issue regulations requiring persons to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, regulatory, and counter-terrorism matters. The regulations implementing the BSA appear at 31 CFR chapter X. The Secretary's authority to administer the BSA has been delegated to the Director of FinCEN.2

Under 31 U.S.C. 5314 the Secretary is authorized to require any “resident or citizen of the United States or a person in, and doing business in, the United States, to . . . keep records and file reports, when the resident, citizen, or person makes a transaction or maintains a relation for any person with a foreign financial agency.” The term “foreign financial agency” encompasses the activities found in the statutory definition of “financial agency,” 3 which means, in pertinent part, “a person acting for a person as a financial institution, bailee, depository trustee, or agent, or acting in a similar way related to money, credit, securities, gold, or a transaction in money, credit, securities, or gold.” 4 The Secretary is also authorized to prescribe exemptions to the reporting requirement and to prescribe other matters the Secretary considers necessary to carry out section 5314.5

The regulations implementing 31 U.S.C. 5314 appear at 31 CFR 1010.350, 1010.306, and 1010.420. Section 1010.350 generally requires each U.S. person having a financial interest in, or signature or other authority over, a bank, securities, or other financial account in a foreign country to report such relationship to the Commissioner of Internal Revenue for each year in which such relationship exists, and provide such information as shall be specified in a reporting form prescribed under 31 U.S.C. 5314 to be filed by such persons. Section 1010.306 requires the form to be filed with respect to foreign financial accounts exceeding $10,000 maintained during the previous calendar year. The form must be filed on or before June 30 of each calendar year for accounts maintained during the previous calendar year.6 The form used to file the report required by section 1010.350 is the Report of Foreign Bank and Financial Accounts—FinCEN Form 114 (“FBAR”), which, since July 1, 2013, must be filed electronically.7 Section 1010.420 requires records of foreign financial accounts to be maintained for each U.S. person having a financial interest in or signature or other authority over such accounts. The records must be maintained for a period of five years.8

The authority to enforce the provisions of 31 U.S.C. 5314 and its implementing regulations has been re-delegated from FinCEN to the Commissioner of Internal Revenue by means of a Memorandum of Agreement between FinCEN and the Internal Revenue Service (“IRS”) dated April 2, 2003.9 With this delegation, FinCEN conferred upon the IRS the authority to enforce the FBAR provisions of the BSA and its implementing regulations, investigate possible violations, and assess and collect civil penalties in connection therewith. The delegation also conferred upon the IRS the authority to: (1) Respond to public inquiries and requests for advice, (2) issue administrative rulings, and (3) provide related assistance to the public with respect to compliance with FBAR requirements. Finally, the delegation conferred upon the IRS the authority to revise the FBAR form and instructions, and to propose to FinCEN revisions of the applicable regulations for the purpose of enhancing FBAR compliance and enforcement.10

Prior to 2011, FinCEN's FBAR regulation text referred filers to the FBAR form instructions for guidance as to the specific information to be reported on the FBAR. The detailed requirements for reporting were included in the FBAR form instructions previously issued by the IRS and FinCEN. A revised FBAR form, which modified several aspects of the instructions to the form, was issued in October 2008. In the ensuing months, a number of questions and comments were received from the public seeking guidance on compliance with the revised instructions. In response to these questions and comments, FinCEN, in consultation with the IRS, issued a Notice of Proposed Rulemaking revising the reporting rules.11 The proposal was finalized in 2011 (the “2011 FBAR regulations”).12

As part of the 2011 FBAR regulations, FinCEN included changes to exemptions, which previously appeared only in the instructions to the FBAR form, for certain U.S. persons with signature or other authority over the foreign financial accounts of certain types of federally regulated entities. These changes expanded the exemptions so that they applied to accounts held by more types of federally regulated entities.

As a result, officers and employees of the federally regulated entities (“covered entities”) listed below, are currently exempt from FBAR reporting for their signature authority over the entities' foreign financial accounts if the officer or employee has no financial interest in the foreign account:

• A bank examined by a Federal banking agency;

• a financial institution registered with and examined by the Securities and Exchange Commission (“SEC”) or the Commodity Futures Trading Commission (“CFTC”);

• an Authorized Service Provider with signature authority over a foreign financial account owned or maintained by an investment company registered with the SEC; 13

• an entity with a class of equity securities listed (or American depository receipts listed) on any U.S. national securities exchange (“listed corporation”) or a U.S. subsidiary if the subsidiary is included in the consolidated report the parent filed; 14 or

• an entity that has a class of equity securities registered (or American depository receipts registered) under section 12(g) of the Securities Exchange Act (“section 12(g) corporation”).15

Subsequent to the publication of the 2011 amendments to the FBAR regulation, FinCEN received several questions from industry with respect to the signature authority exemptions. In particular, many filers asked how the exemptions applied with respect to scenarios involving overlapping signature authority.16 Many filers were unsure of the breadth of the amended exemptions as they applied to scenarios involving over-lapping signature authority. “Over-lapping” signature authority occurs when an officer or employee of a parent entity also has signature authority over the foreign financial accounts of the parent's controlled subsidiary entity and vice versa. Under a literal reading of the regulation, the exemption only applies if the individual is actually “an officer or employee of” the particular corporate entity that holds the account, and not to situations in which the individual may have control over accounts held by affiliated corporate or other business entities that do not employ the individual. 17

Invitation to Comment:

We invite you to submit comments regarding this notice. To ensure that your comments have maximum effect in developing the notice of final priorities and definitions, we urge you to identify clearly the specific proposed priority or definition that each comment addresses.

We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from these proposed priorities and definitions. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

During and after the comment period, you may inspect all public comments about this notice by accessing Regulations.gov. You may also inspect the comments in room 3E203, 400 Maryland Avenue SW., Washington, DC 20202, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays. Please contact the person listed under FOR FURTHER INFORMATION CONTACT.

Assistance to Individuals with Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

Purpose of Program: The Fulbright-Hays GPA Program supports short-term and long-term overseas projects in training, research, and curriculum development in modern foreign languages and area studies for groups of teachers, undergraduate and graduate students, and faculty engaged in a common endeavor. Fulbright-Hays GPA short-term projects (GPA short-term projects) may include seminars, curriculum development, or group research or study. Fulbright-Hays GPA long-term projects (GPA long-term projects) support advanced overseas intensive programs that focus on the humanities, social sciences, or languages.

Program Authority: 22 U.S.C. 2452(b)(6).

Applicable Program Regulations: 34 CFR parts 662 and 664.

PROPOSED PRIORITIES:

This notice contains two proposed priorities, one for GPA short-term projects and one for GPA long-term projects.

Background:

The U.S. Department of Education administers the Fulbright-Hays GPA Program under the authority of section 102(b)(6) of the Mutual Educational and Cultural Exchange Act of 1961 (Fulbright-Hays Act), 22 U.S.C. 2452(b)(6). The J. William Fulbright Foreign Scholarship Board, which is presidentially appointed, sets policies and procedures for administering the program and exercises final approval over the selection of grantees and fellows for GPA short-term projects and GPA long-term projects.

The objective of the Fulbright-Hays GPA Program is the promotion, improvement, and development of modern foreign languages and area studies at varying levels of education. To help achieve this objective, the program provides opportunities for faculty, teachers, and undergraduate and graduate students to conduct individual and group projects overseas to carry out research and study in the fields of modern foreign languages and area studies.

There are three types of GPA short-term projects: (1) Short-term seminar projects of four to six weeks in length designed to increase the linguistic or cultural competency of U.S. students and educators by focusing on a particular aspect of area study, such as the culture of an area or country of study (34 CFR 664.11); (2) curriculum development projects of four to eight weeks in length that provide participants an opportunity to acquire resource materials for curriculum development in modern foreign language and area studies for use and dissemination in the United States (34 CFR 664.12); and (3) group research or study projects of three to twelve months in duration designed to give participants the opportunity to undertake research or study in a foreign country (34 CFR 664.13).

GPA long-term projects are advanced overseas intensive language projects ranging in duration from eight weeks to four years. GPA long-term projects are designed to take advantage of the opportunities present in the foreign country that are not present in the United States when providing intensive advanced foreign language training (34 CFR 664.14).

The Department's International Strategy for FY 2012-16, “Succeeding Globally Through International Education and Engagement,” available at http://www2.ed.gov/about/inits/ed/internationaled/international-strategy-2012-16.html (U.S. Department of Education, 2012), reflects our commitment to preparing students for a more globalized world, and to engaging with the international community in order to improve education. The International Strategy's first objective is to “increase the global competencies of all U.S. students, including those from traditionally disadvantaged groups.” (U.S. Department of Education, 2012, p.5). Minority-Serving Institutions (MSIs) and community colleges are heavily populated by students from traditionally disadvantaged groups. Twenty-five percent or more of all high school graduates of color, who often are first-generation college attendees, enroll in community colleges as a way to begin their foray into higher education (Edsource, 2008). Research data indicate that minority students are less likely to have access to, or consider, academic programs that provide the requisite training for careers in international service, including study abroad and area studies (Tillman, 2010). Among the barriers preventing these students from pursuing international studies are a lack of exposure to international opportunities and a lack of access to information, including information about international careers (Belyavina and Bhandari, 2011). In addition, traditionally disadvantaged students often have the idea that study abroad is not for them and is a privilege for rich students (Martinez, Ranjeet, and Marx, 2009).

Accordingly, the proposed priority for GPA short-term projects is intended to increase the number of applications from MSIs, community colleges, and new applicant institutions to provide access to life-changing opportunities that will prepare traditionally disadvantaged students for today's global economy. The proposed priority is designed to increase the number and types of students that benefit from these projects. By increasing applications from MSIs and community colleges, we expect these projects to benefit greater numbers of traditionally disadvantaged students.

To further support the Department's objective of increasing the global competencies of all U.S. students, the proposed priority would expand the reach of the GPA short-term and long-term overseas projects by encouraging applications from new applicant institutions—that is, institutions or entities that have not previously been awarded either a GPA short-term or long-term project grant. Over the years, the Fulbright-Hays GPA Program has received applications from the same pool of applicants. This priority is an attempt to encourage applications from institutions that have not been awarded a GPA grant.

The proposed priority for GPA short-term projects is intended to promote applications from State educational agencies (SEAs) in order to increase international learning opportunities for teachers and administrators from the corresponding State, who would work together on a research or curriculum development project that would benefit greater numbers of K-12 students. Historically, only a small number of SEAs have applied for GPA grants.

Furthermore, while existing programs provide some individual educators with opportunities for foreign language learning, study abroad, and other international studies, there are few systemic opportunities for groups of K-12 educators and administrators from a State or local district to work together on a research or curriculum development project intended to build global competencies in their students.

The proposed priority for GPA long-term projects is designed to increase the number of MSIs that become grantees under these projects, in order to increase their students' access to academic coursework, instructional activities, and training that would better prepare them for the 21st-century global economy, careers in international service, and for lifelong engagement with the diverse communities in which they live, whether at home or abroad.

Proposed Priorities:

Proposed Priority 1—Applications for GPA Short-term Projects from Selected Institutions and Organizations.

Applications for GPA short-term projects from the following types of institutions and organizations:

Proposed Priority 2—Applications for GPA Long-term Projects from Minority-Serving Institutions (MSIs).

Applications for GPA long-term advanced overseas intensive language training projects from MSIs.

Types of Priorities:

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register. The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 5.105(c)(1)).

PROPOSED DEFINITIONS: The Assistant Secretary proposes the following definitions for this program. We may apply one or more of these definitions in any year in which this program is in effect.

Background: We propose the following definitions to provide clarity for applicants addressing the proposed priorities. The proposed definitions for “community colleges,” “MSIs,” and “SEAs” are from section 312(f) of the Higher Education Act of 1965, as amended (HEA); sections 316 through 320 of part A of title III of the HEA; and 34 CFR 77.1, respectively. These proposed definitions will provide consistency across Department programs and will be familiar to applicants. For purposes of Proposed Priority 1, the proposed definition for “new applicant” is similar to the definition used in previous years and is designed to expand the reach of the GPA short-term projects to include institutions and entities that have not previously received a GPA grant.

Definitions:

Community college means an institution that meets the definition in section 312(f) of the HEA (20 U.S.C. 1058(f)); or an institution of higher education (as defined in section 101 of the HEA (20 U.S.C. 1001)) that awards degrees and certificates, more than 50 percent of which are not bachelor's degrees (or an equivalent).

Minority-serving institution (MSI) means an institution that is eligible to receive assistance under sections 316 through 320 of part A of title III, under part B of title III, or under title V of the HEA.

New applicant means any applicant that has not received a discretionary grant from the Department of Education under the Fulbright-Hays Act prior to the deadline date for applications under this program.

State educational agency (SEA) means the State board of education or other agency or officer primarily responsible for the supervision of public elementary and secondary schools in a State. In the absence of this officer or agency, it is an officer or agency designated by the Governor or State law.

Final Priorities and Definitions:

We will announce the final priorities and definitions in a notice in the Federal Register. We will determine the final priorities and definitions after considering responses to this notice and other information available to the Department. This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, the Secretary must determine whether this proposed regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this proposed regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing these proposed priorities and definitions only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps ensure that: the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.

The application package associated with Proposed Priority 1—Applications for GPA Short-term Projects from Selected Institutions and Organizations—was previously approved by the Office of Management and Budget (OMB) under OMB control number 1840-0792. Proposed Priority 1 and the proposed definitions will not change the currently approved application package, or the approved burden for the application package associated with the short-term projects. However, the application package associated with Proposed Priority 2—Applications for GPA Long-term Projects from Minority-Serving Institutions (MSIs)—does not have a current OMB control number, and therefore, it will require OMB approval under 1840-xxxx. As required by the PRA, the Department is submitting to OMB, under OMB control number 1840-xxxx, an information collection clearance concurrently with the publication of this notice of proposed priorities and definition for long-term projects under CFDA number 84.021B.

We estimate that each applicant would spend approximately 100 hours of staff time to address the proposed priorities and definitions, prepare the application, and obtain necessary clearances. The total number of hours for all applicants will vary based on the number of applications. Based on the number of applications the Department received in response to the February 23, 2012 notice inviting applications, we expect to receive approximately 150 applications. We expect each applicant to require 100 hours to complete a GPA long-term project application. Accordingly, the total number of hours for all expected applicants is an estimated 15,000 hours. We estimate the total cost per hour of the staff who carry out this work to be $80.00 per hour. The total estimated cost for all applicants would be $1,200,000.00.

We have prepared an Information Collection Request (ICR) for this collection (1840-XXXX). If you want to review and comment on the ICR, please follow the instructions in the ADDRESSES section of this notice.

In preparing your comments you may want to review the ICR, including the supporting materials, in www.regulations.gov by using the Docket ID number specified in this notice. This proposed collection is identified as proposed collection 1840-XXXX.

We consider your comments on this proposed collection of information in—

• Deciding whether the proposed collection is necessary for the proper performance of our functions, including whether the information will have practical use;

• Evaluating the accuracy of our estimate of the burden of the proposed collection, including the validity of our methodology and assumptions;

• Enhancing the quality, usefulness, and clarity of the information we collect; and

• Minimizing the burden on those who must respond. This includes exploring the use of appropriate automated, electronic, mechanical, or other technological collection techniques.

Between 30 and 60 days after publication of this document in the Federal Register, OMB is required to make a decision concerning the collection of information contained in these proposed priorities and definitions. Therefore, to ensure that OMB gives your comments full consideration, it is important that OMB receives your comments on this ICR by April 11, 2016. This does not affect the deadline for your comments to us on the proposed priorities and definitions.

If your comments relate to the ICR for these proposed priorities and definitions, please specify the Docket ID number and indicate “Information Collection Comments” on the top of your comments.

Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

VA is considering issuing a proposed rulemaking that would amend part 14 of title 38, Code of Federal Regulations, to provide for the recognition of Tribal organizations so that representatives of the organizations may assist Native American claimants in the preparation, presentation, and prosecution of their VA benefit claims. The purpose of the proposed rulemaking would be to address the needs of Native American populations who are geographically isolated from existing recognized Veterans Service Organizations or who may not be utilizing other recognized Veterans Service Organizations due to cultural barriers or lack of familiarity with those organizations.

First, the proposed rulemaking would allow the Secretary of Veterans Affairs to recognize Tribal organizations in a similar manner as the Secretary recognizes State organizations. Specifically, the proposed rulemaking would consider applications from a Tribal organization that is established and funded by one or more Tribal governments to be recognized for the purpose of providing assistance on VA benefit claims. In addition, the proposed rulemaking would allow an employee of a Tribal government to become accredited through a recognized State organization in a similar manner as a county veterans' service officer may become accredited through a recognized State organization. Finally, the proposed rulemaking would extend office space opportunities already granted to employees of State organizations who are accredited to national organizations to similar employees of Tribal organizations. The intended effect of this proposed rule would be to improve access of Native American veterans to VA-recognized organizations and VA-accredited individuals who may assist them on their benefit claims. The proposed rulemaking would not preempt Tribal law. This Tribal consultation is seeking input from Tribal governments regarding VA's consideration of the issuance of such proposed rulemaking. VA is also seeking comment on the potential compliance costs.

In order to become accredited as a Tribal organization, the organization must show that it meets the requirements in 38 CFR 14.628(d). Pursuant to § 14.628(d), an organization requesting recognition must have as a primary purpose serving veterans; demonstrate a substantial service commitment to veterans either by showing a sizable organizational membership or by showing performance of veterans' services to a sizable number of veterans; commit a significant portion of its assets to veterans' services and have adequate funding to properly perform those services; maintain a policy and capability of providing complete claims service to each claimant requesting representation or give written notice of any limitation in its claims service with advice concerning the availability of alternative sources of claims service; and take affirmative action, including training and monitoring of accredited representatives, to ensure proper handling of claims. VA is seeking comment on the amount of time and the costs of persons' time to show that the organization meets these requirements. VA's Office of the General Counsel accepts recognition requests via mail, fax, or email.

Signing Authority: The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert D. Snyder, Interim Chief of Staff, approved this document on March 3, 2016, for publication.

In the Rules and Regulations section of this Federal Register, EPA is approving Ohio's SIP revision submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that, if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information see the direct final rule, which is located in the Rules section of this Federal Register.

In the Rules and Regulations section of this Federal Register, the EPA is approving the State's SIP submittal as a direct rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated. If the EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

For additional information, see the direct final rule which is located in the Rules and Regulations section of this Federal Register.

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

The California Air Resources Board's (CARB) Off-Road Diesel-Fueled Fleets Regulation (13 CCR sections 2449, 2449.1 and 2449.2) applies to fleets with nonroad 1 compression-ignition vehicles and equipment greater than 25 horsepower (hp). Sections 2449 and 2449.1 (collectively the “Off-Road Regulation”) require fleet operators to meet a progressively more stringent combined particulate matter (PM) and NOX standard, or to reduce emissions through technology upgrades such as retrofit or replacement. The Off-Road Regulation was initially approved by CARB on July 26, 2007 and was subsequently amended in December 2010.

In conjunction with the Off-Road Regulation, CARB also adopted an “opt-in” provision that allows local air districts to achieve additional reductions of NOX emissions by introducing cleaner engines or control devices into a fleet with incentive funding (see 13 CCR section 2449.2, Surplus Off-Road Opt-In for NOX Program (also referred to as the “CARB SOON Program” in today's proposed rule)). Under this provision, any California air district can “opt-in” to the CARB SOON Program to achieve reductions of NOX emissions from in-use nonroad diesel-fueled vehicles that are surplus to what is required by CARB's Off-Road Regulation. In order to participate in the CARB SOON Program, a district's governing board must hold a public hearing, vote to “opt-in” to the CARB SOON Program, and decide whether to make the program voluntary or mandatory.

On May 2, 2008 the SCAQMD governing board held a public hearing at which it voted to “opt-in” to the CARB SOON Program as a mandatory requirement and adopted Rule 2449, Control of Oxides of Nitrogen Emissions from Off-Road Diesel Vehicles, which includes by reference the CARB SOON Program. The SCAQMD also adopted additional Rule 2449 Administrative Guidelines (May 2008) as required by the CARB SOON Program to implement the program in the South Coast area. On July 11, 2014, the SCAQMD amended Rule 2449 to update the rule's reference to the CARB SOON Program, which was amended by CARB in December 2011. The SCAQMD Rule 2449 adopts the provisions of the CARB SOON Program found under 13 CCR, section 2449.2 into the SCAQMD's rule book and makes the CARB SOON Program a mandatory requirement for in-use off-road sources located in the South Coast area.2

CARB's Off-Road Regulation and the CARB SOON Program are subject to section 209(e) of the Clean Air Act (CAA or the Act), which generally preempts States from adopting and enforcing standards and other requirements relating to the control of emissions from nonroad engines (see CAA section 209(e)(1) and Engine Mfrs. Ass'n v. EPA, 88 F.3d 1075 (D.C. Cir. 1996)). However, CAA section 209(e)(2)(A) requires the EPA to authorize California to adopt and enforce standards and other requirements relating to the control of emissions from certain nonroad vehicles or engines, unless the EPA makes one of three enumerated findings. On September 20, 2013 the EPA authorized CARB to enforce the Off-Road Regulation and the CARB SOON Program (collectively “Fleet Requirements”) (see 78 FR 58090-58121, September 20, 2013).

On November 12, 2015, the EPA proposed to approve the Fleet Requirements into the California SIP (see 80 FR 69915).3

On July 18, 2008, the State of California submitted SCAQMD Rule 2449, “Control of Oxides of Nitrogen Emissions from Off-Road Vehicles,” which was adopted by the District on May 2, 2008 (see July 18, 2008 letter from Michael H. Scheible, Deputy Executive Officer, CARB, to Wayne Nastri, Regional Administrator, EPA Region 9, with attachments).

On September 5, 2014, the state submitted a revision to Rule 2449 adopted by the District on July 11, 2014. The submittal made a minor administrative revision to the numbering of the referenced CARB SOON Program, which was revised by CARB in December 2011, from section 2449.3 to section 2449.2 (see September 5, 2014 letter to Jared Blumenfeld, Regional Administrator, EPA Region 9, from Richard W. Corey, Executive Officer, Air Resources Board with attachments).

The July 18, 2008 submittal was deemed complete by operation of law under CAA section 110(k)(1)(B) on January 18, 2009. The September 5, 2014 submittal was deemed complete by operation of law under CAA section 110(k)(1)(B) on March 5, 2015.

There are no previous versions of Rule 2449 in the SIP for the SCAQMD.

NOX helps produce ground-level ozone, smog and fine particulate matter (PM2.5), which harm human health and the environment. Section 110(a) of the CAA requires States to submit regulations that control NOX emissions. In addition, section 172(c)(1) of the Act requires implementation of all reasonably available control measures (RACM) as expeditiously as practicable in nonattainment areas. Because the South Coast area is designated nonattainment for the 1-hour ozone standard, the 1997 annual and 24-hour PM2.5 standard, the 2006 24-hour PM2.5 standard, the 2012 annual PM2.5 standard, the 1997 8-hour ozone standard and the 2008 8-hour ozone standard (see 40 CFR part 81.305), CARB and the SCAQMD must implement RACM for NOX (among other pollutants) under CAA section 172(c)(1). In addition, under subpart 4 of the CAA, serious PM2.5 areas are required to adopt best available control measures (BACM) for PM2.5 and its precursors.4 On January 13, 2016, the EPA reclassified the South Coast PM2.5 nonattainment area as a Serious nonattainment area for the 2006 PM2.5 NAAQS (81 FR 1514).

Off-road diesel vehicles collectively represent one of the largest sources of NOX emissions in the South Coast Air Basin.5 The purpose of Rule 2449 is to achieve surplus NOX reductions from this source category beyond those required under CARB's Off-Road Regulation with funding provided by the SCAQMD. The SCAQMD's 2012 Air Quality Management Plan (AQMP) relies on NOX reductions from Rule 2449 to attain the one-hour and 1997 eight-hour ozone NAAQS.6 Rule 2449 is expected to achieve 7.5 tons per day (tpd) of NOX reductions in 2023.7

In general, CARB's Off-Road Regulation applies to all diesel-fueled off-road fleet equipment owners operating in the State of California. The Off-Road Regulation has performance requirements depending on the size of the fleet (i.e., a large fleet is defined as a fleet having greater than 5,000 horsepower (hp), a small fleet has less than or equal to 2,500 hp, and a medium fleet is in between) 8 and provides calculation methodologies for determining a fleet average index and a fleet average target rate. Each year, each subject fleet must demonstrate that its fleet average index was less than or equal to the applicable fleet average target rate or that it met Best Available Control Technology (BACT) requirements by performing turnover or installing verified diesel emission control strategies (VDECS).9 As discussed above, the EPA has authorized CARB to implement the Off-Road Regulation under CAA section 209(e) (78 FR 58090) and has proposed to approve the Off-Road Regulation into the California SIP (80 FR 69915).

SCAQMD Rule 2449 focuses on the largest fleets with the oldest engines and requires these fleets to meet more stringent fleet average targets than those required by section 2449.1(a) of the Off-Road Regulation. In general, Rule 2449 applies to the owners 10 of off-road vehicles that operate within the SCAQMD and that are part of fleets with more than 40 percent Tier 0 and Tier 1 vehicles 11 (as of January 1, 2008) and with more than 20,000 horsepower (hp) in maximum power on a statewide basis (excluding the hp from engines in two-engine vehicles and the hp from single cranes formerly subject to the Cargo Handling Equipment Regulation).12

Once the District issues a solicitation for applications for funding under Rule 2449, subject fleet owners are required to meet the more stringent fleet average targets required by the CARB SOON Program or apply for incentive funding for a sufficient number of projects (e.g., repowers, purchases, replacements) to meet the CARB SOON Program fleet average targets (reproduced in Table 1 below).13

Specifically, subject fleet owners are required to submit a report with information on, including but not limited to, the fleet owner, vehicle types and uses of each vehicle, engines used to power the vehicles and the type and use of each engine, and VDECS installed on engines. 13 CCR section 2449.2(d)(1)(A)). Fleets must calculate their fleet average index based on the equipment they have and compare it to the fleet average target rate based on the SOON target rates shown in Table 1 above (13 CCR section 2449.2(d)(1)(B) and (C)), and if their fleet average index is greater than the SOON fleet average target rate, they are required to apply for funding (13 CCR section 2449.2(d)(1)(D)). Fleets must apply for funding in accordance with the Carl Moyer Memorial Air Quality Standards Attainment Program (Carl Moyer Program) 14 policies and procedures and also with the Administrative Guidelines 15 adopted by the SCAQMD, which provide further clarification on what to include in the funding applications and compliance plans. Funding applications and compliance plans must together demonstrate that equipment identified for the CARB SOON Program funding will result in surplus 16 reductions in order to qualify for incentive funding. Once a fleet receives funding for a qualified project, the fleet is required to implement the project. The SCAQMD has approved significant funding for the implementation of Rule 2449. The 2012 AQMP states that the District Governing Board has allocated up to $30 million per year for the program and extended the SOON Program to 2023 (see Final 2012 AQMP: Appendix IV-B, p. IV-B-31). For “FY 2015-2016,” or “Year 18” of the Carl Moyer Memorial Air Quality Standards Attainment Program, the SCAQMD expects that approximately $5 million of funding will be available for the SCAQMD SOON Program (see DRAFT Technology Committee Agenda #1, prepared for BOARD MEETING DATE: March 4, 2016, page 3).

The EPA has evaluated Rule 2449 against the applicable procedural and substantive CAA requirements for SIPs and SIP revisions and has concluded that it meets all of the applicable requirements.

Generally, SIPs must include enforceable emission limitations and other control measures, means, or techniques, as well as schedules and timetables for compliance, as may be necessary to meet the requirements of the Act (see CAA section 110(a)(2)(A)); must provide necessary assurances that the State will have adequate personnel, funding, and authority under State law to carry out such SIP (and is not prohibited by any provision of Federal to State law from carrying out such SIP) (see CAA section 110(a)(2)(E)); must be adopted by a State after reasonable notice and public hearing (see CAA section 110(l)), and must not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act (see CAA section 110(l)).17

In addition, as noted above, CARB and the SCAQMD must implement RACM for NOX (among other pollutants) under CAA section 172(c)(1).

Under CAA section 110(l), SIP revisions must be adopted by the State, and the State must provide for reasonable public notice and hearing prior to adoption. In 40 CFR 51.102(d), we specify that reasonable public notice in this context refers to at least 30 days. The State has submitted evidence of public notice and hearing prior to the May 5, 2008 adoption and July 11, 2014 amendment of Rule 2449 by the SCAQMD (see attachments to July 18, 2008 letter to Mr. Wayne Nastri, EPA Region 9 from Michael H. Scheible, Air Resource Board and attachments to September 5, 2014 letter to Mr. Jared Blumenfeld, EPA Region 9, from Richard W. Corey, Air Resources Board). Based on the evidence provided by the SCAQMD and CARB, we conclude that they have provided adequate public notice and comment periods.

California air districts are authorized to adopt and enforce rules by California Health and Safety Code (H&SC) section 40001. CARB is authorized to adopt the rules as revisions to the SIP by H&SC section 39601, 39602, and 41650 through 41652 (see CARB Executive Order S-14-012).

In addition, we note that California H&SC sections 43013(a) and 43018 provide CARB with broad authority to achieve the maximum feasible and cost-effective emission reductions from all mobile source categories, including both on-road and off-road diesel engines.

As discussed above, CARB's Off-Road Regulation is subject to CAA section 209(e), and on September 20, 2013 the EPA granted CARB's request for authorization to enforce its Fleet Requirements, including the CARB SOON Program (see 78 FR 58090-58121, September 20, 2013). Thus, we find that the SCAQMD and CARB have adequate legal authority to adopt and implement Rule 2449.

We have evaluated the enforceability of Rule 2449 and the CARB SOON Program with respect to applicability and exemptions; standard of conduct and compliance dates; sunset provisions; discretionary provisions; and test methods, recordkeeping and reporting,18 and have concluded for the reasons given below that the rule is enforceable for the purposes of CAA section 110(a)(2).

First, with respect to applicability, we find Rule 2449 and the CARB SOON Program to be sufficiently clear as to which fleet owners and which vehicles or engines are subject to the program and the rule (see Rule 2449 and 13 CCR section 2449.2(b)). In general, the rule applies to owners of vehicles that operate within the SCAQMD and are part of a fleet consisting of 40 percent Tier 0 and Tier 1 vehicles with greater than 20,000 hp statewide, excluding the hp from engines in two-engine vehicles and single engine cranes formerly subject to the Cargo Handling Equipment Regulation (see 13 CCR 2449.2(b)(2)).

Second, we find that Rule 2449 and the CARB SOON Program are sufficiently specific so that the persons affected are fairly on notice as to what the requirements and related compliance dates are. We have described the substantive requirements and compliance dates set forth in Rule 2449 in section II.D. of today's proposed rule.

Third, the requirements of Rule 2449 will sunset at different times from 2011 through 2023, depending on when the SCAQMD issues its solicitations for funding; however, once a fleet is no longer subject to Rule 2449, it will be then be subject to the requirements of the Off-Road Regulation.

Fourth, Rule 2449 contains a provision that allows for discretion on the part of CARB's Executive Officer (EO), this provision is limited both in scope and application, and is no longer relevant since the date to request discretion has passed (see 13 CCR section 2449.2(e)(2), allowing a fleet to apply to the EO for an extension from the requirements if the rule calculations would require a fleet to turn over Tier 2 or better engines before January 1, 2014). As such, we find that this provision does not undermine the enforceability of Rule 2449 or preclude its approval into the SIP.

Lastly, Rule 2449 identifies appropriate calculation requirements and includes adequate recordkeeping and reporting requirements sufficient to ensure compliance with the applicable requirements. In particular, as described above, once the SCAQMD issues a solicitation, each subject fleet owner must submit a report containing detailed information about each vehicle and engine in the fleet, each VDECS installed on an engine in the fleet, and other information related to compliance with the Off-Road Rule (see 13 CCR 2449(d)(1)(A) and 2449(g). If the fleet average index is greater than the SOON fleet average target rate, the fleet owner must apply for SOON funding (13 CCR 2449.2(d)(1)(B)). If the necessary NOX retrofits, repower, or vehicle replacements are available, the application must indicate how these retrofits, repowers, or vehicle replacements would bring the fleet average index for vehicles that operate within the SCAQMD to less than or equal to the SOON fleet average target rate (13 CCR 2449.2(d)(1)(D)). In addition, the fleet owner must prepare and submit a compliance plan laying out the actions it is required to take under section 2449.1 and the actions for which it is applying to the SCAQMD for funding under section 2449.2 (13 CCR 2449.2(e)(3)).

As discussed above, the SCAQMD's 2012 AQMP relies on NOX reductions from Rule 2449 to attain the one-hour and 1997 eight-hour ozone NAAQS. The EPA has approved SCAQMD's commitment to implement the SOON Program as part of the SCAQMD's aggregate NOX emissions reductions commitment (see 79 FR 29712, 29720 and 29721). Approval of Rule 2449 into the SIP will help fulfill this commitment. Thus, the EPA believes that approval of Rule 2449 does not interfere with Reasonable Further Progress, attainment or any other applicable requirement of the Act.

As discussed above, the SCAQMD has approved significant funding for the implementation of Rule 2449. The 2012 AQMP states that the SCAQMD Board has allocated up to $30 million per year for the program and extended the SOON Program to 2023 (see Final 2012 AQMP: Appendix IV-B, p. IV-B-31). For “FY 2015-2016,” or “Year 18” of the Carl Moyer Memorial Air Quality Standards Attainment Program, the SCAQMD expects to have approximately $5 million of funding available for the SCAQMD SOON Program (see DRAFT Technology Committee Agenda #1, prepared for BOARD MEETING DATE: March 4, 2016, page 3).

Rule 2449 provides for the most stringent in-use off-road diesel equipment requirements that we are aware of in the United States, and thus, we find that the rule implements both reasonably available and best available control measures for this source category. However, as discussed above, the EPA generally takes action on a RACM or BACM demonstration as part of our action on the State's attainment demonstration for the relevant NAAQS. Thus, while we do not know of any more stringent requirements for this category at this time, we are also not taking any action on how this measure fits within the context of a RACM or BACM demonstration for the South Coast area.

Based on the above discussion, we believe Rule 2449 and the CARB SOON Program are consistent with the relevant CAA requirements, policies and guidance.

As authorized in section 110(k)(3) of the Act, the EPA is proposing to fully approve the submitted rule because we believe it fulfills all relevant requirements. We will accept comments from the public on this proposal until April 11, 2016. Unless we receive convincing new information during the comment period, we intend to publish a final approval action that will incorporate this rule into the federally enforceable SIP.

In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference SCAQMD Rule 2449. The EPA has made, and will continue to make, this document available electronically through www.regulations.gov and in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the 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 and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Department encourages the public to participate in this advance notice of proposed rulemaking (ANPRM), by submitting comments and related materials to the appropriate dockets. Where possible, the Department would like the public to provide scientific peer-reviewed data to support comments.

If you submit a comment, please include the docket number for this ANPRM (FMCSA-2015-0419 and FRA-2015-0111), indicate the heading of the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online, by fax, mail, or hand delivery, but please use only one of these means. The Department recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so an Agency can contact you if it has questions regarding your submission.

To submit your comment online, go to www.regulations.gov, type the docket number, “FMCSA-2015-0419” or “FRA-2015-0111 in the “Keyword” box, and click “Search.” When the new screen appears, click the “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. The Agencies will consider all comments and material received during the comment period and will use them to inform any future rulemaking proposals.

To view comments and any document mentioned in this preamble, go to www.regulations.gov, insert the docket number, “FMCSA-2015-0419” or “FRA-2015-0111” in the “Keyword” box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document listed to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Services in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.

Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its potential rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

FMCSA has authority under 49 U.S.C. 31136(a) and 31502(b)—delegated to the Agency by 49 CFR 1.87(f) and (i), respectively—to establish minimum qualifications, including medical and physical qualifications, for commercial motor vehicle (CMV) drivers operating in interstate commerce. Section 31136(a)(3) requires that FMCSA's safety regulations ensure that the physical conditions of CMV drivers enable them to operate their vehicles safely, and that medical examiners (MEs) trained in physical and medical examination standards perform the physical examinations required of such operators.

In 2005, Congress authorized FMCSA to establish a Medical Review Board (MRB) composed of experts “in a variety of medical specialties relevant to the driver fitness requirements” to provide advice and recommendations on qualification standards. 49 U.S.C. 31149(a). The position of FMCSA Chief Medical Examiner was authorized at the same time. 49 U.S.C. 31149(b). Under section 31149(c)(1), FMCSA, with the advice of the MRB and Chief Medical Examiner, is directed to “establish, review and revise . . . medical standards for operators of commercial motor vehicles that will ensure that the physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely.” As discussed below, FMCSA, in conjunction with the Chief Medical Examiner, asked the MRB to review and report specifically on OSA. The MRB's recommendations are described in the MRB and Motor Carrier Safety Advisory Committee (MCSAC) Recommendations section of this ANPRM.

Under 49 U.S.C. 20103, the Secretary of Transportation (Secretary) has broad authority to issue regulations governing every area of railroad safety. The Secretary has delegated rulemaking responsibility under section 20103 to the Administrator of FRA. 49 CFR 1.89(a). The railroad incidents discussed below illustrate the risks to railroad safety posed by railroad employees that have moderate-to-severe OSA. Moreover, FRA has exercised this safety authority to require other medical testing. FRA regulations require locomotive engineers (49 CFR 240.121) and conductors (49 CFR 242.117) to undergo vision and hearing testing as part of their qualification and certification at least every 3 years. There are individual medical circumstances that may lead a railroad to require some engineers or conductors to undergo more frequent testing. In addition, Congress has authorized the Secretary to consider requiring certification of the following other crafts and classes of employees: (1) Car repair and maintenance employees; (2) onboard service workers; (3) rail welders; (4) dispatchers; (5) signal repair and maintenance employees; and (6) any other craft or class of employees that the Secretary determines appropriate. Therefore, the Secretary, and the FRA Administrator by delegation, has statutory authority to issue regulations to address the safety risks posed by employees in safety sensitive positions with OSA.

OSA is a respiratory disorder characterized by a reduction or cessation of breathing during sleep. OSA is characterized by repeated episodes of upper airway collapse in the region of the upper throat (pharynx) that results in intermittent periods of partial airflow obstruction (hypopneas), complete airflow obstruction (apneas), and respiratory effort-related arousals from sleep (RERAs) in which affected individuals awaken partially and may experience gasping and choking as they struggle to breathe. Risk factors for developing OSA include: Obesity, male gender, advancing age, family history of OSA, large neck size, and an anatomically small oropharynx (throat). Additionally, OSA is associated with increased risk for other adverse health conditions such as: Hypertension (high blood pressure), diabetes, obesity, cardiac dysrhythmias (irregular heartbeat), myocardial infarction (heart attack), stroke, and sudden cardiac death.

Individuals who have undiagnosed OSA are often unaware they have experienced periods of sleep interrupted by breathing difficulties (apneas, hypopneas, or RERAs) when they awaken in the morning. As a result, the condition is often unrecognized by affected individuals and underdiagnosed by medical professionals.

For individuals with OSA, eight hours of sleep can be less restful or refreshing than four hours of ordinary, uninterrupted sleep.1 Undiagnosed or inadequately treated moderate to severe OSA can cause unintended sleep episodes and resulting deficits in attention, concentration, situational awareness, and memory, thus reducing the capacity to safely respond to hazards when performing safety sensitive duties. Thus, OSA is a critical safety issue that can affect operations in all modes of travel in the transportation industry.

The following paragraphs provide some examples of accidents where the National Transportation Safety Board (NTSB) determined that OSA played a role in causing an accident (or near-accident) involving motor carriers and trains.

On July 26, 2000, the driver of a tractor-trailer traveling on Interstate 40 near Jackson, Tennessee, collided with a Tennessee Highway Patrol vehicle trailing construction vehicles, killing the state trooper inside. The tractor-trailer then traveled across the median and collided with a Chevrolet Blazer heading in the opposite direction, seriously injuring the driver of the Blazer. The tractor-trailer driver was 5 feet, 11 inches tall, weighed 358 pounds, and had been diagnosed with and undergone surgery for OSA, but had not indicated either the diagnosis or the surgery on examinations for medical certification. The NTSB found that the driver's unreported OSA, untreated hypothyroidism, or complications from either or both conditions predisposed him to impairment or incapacitation, including falling asleep at the wheel while driving. The NTSB determined the probable cause of the accident was the driver's incapacitation, which resulted from the failure of the medical certification process to detect and remove a medically unfit driver from service.2

On April 17, 2011, at approximately 6:55 a.m. CDT, an eastbound BNSF Railway (BNSF) coal train traveling near Red Oak, Iowa collided with the rear end of a standing BNSF maintenance-of-way equipment train. The collision resulted in the derailment of two locomotives and 12 cars, a diesel fuel fire, and the deaths of both crewmembers on the striking train. In its investigative report, the NTSB noted that neither of the fatally injured train crewmembers had undergone a sleep study prior to the incident. However, in each case, medical records indicated that both crewmembers had multiple risk factors for OSA.3 NTSB determined that the probable cause of the accident was “the failure of the crew of the striking train to comply with the signal indication requiring them to operate in accordance with restricted speed requirements and stop short of the standing train because they had fallen asleep due to fatigue resulting from their irregular work schedules and their medical conditions.” 4 NTSB recommended that FRA “require railroads to medically screen employees with safety sensitive duties for sleep apnea and other sleep disorders.” 5

On December 1, 2013, at approximately 7:20 a.m. EST, southbound Metro-North Railroad (Metro-North) passenger train 8808 derailed as it approached the Spuyten Duyvil Station in New York City. All passenger cars and the locomotive derailed, and, as a result, four passengers died and at least 61 passengers were injured. The train was traveling at 82 mph when it derailed in a section of curved track where the maximum authorized speed was 30 mph. Following the accident, the engineer reported that: (1) He felt dazed just before the derailment; 6 and (2) his wife had previously complained about his snoring. The engineer then underwent a sleep evaluation, which identified excessive daytime sleepiness, followed by a sleep study, which diagnosed severe OSA. Based on its investigation of the derailment, the NTSB concluded that the engineer had multiple OSA risk factors, such as obesity, male gender, snoring, complaints of fatigue, and excessive daytime sleepiness. Even though the engineer exhibited these OSA risk factors, neither his personal health care provider nor his Metro-North occupational health evaluations had screened the engineer for OSA.7 NTSB determined that the probable cause of the accident was the “engineer's noncompliance with the 30-mph speed restriction because he had fallen asleep due to undiagnosed severe obstructive sleep apnea exacerbated by a recent circadian rhythm shift required by his work schedule.” 8

On May 25, 2013, at approximately 2:30 a.m., a Union Pacific Railroad (UP) freight train collided with a BNSF freight train at an interlocking near Chaffee, Missouri. The collision resulted in the derailment of 13 cars from the BNSF train, two locomotives and 11 cars from the UP train, and a diesel fuel fire. The two crew members from the UP train were injured and transported to a local hospital. The derailing train cars struck nearby highway bridge supports, resulting in the collapse of portions of the bridge, two motor vehicle accidents, and injury to five motor vehicle occupants. NTSB estimated the total damages to be more than $11 million.9

NTSB determined the probable cause of the accident to be “failure of the Union Pacific Railroad train crewmembers to comply with wayside signals leading into the Rockview Interlocking as a result of their disengagement from their task, likely because of fatigue-induced performance degradation.” NTSB concluded that a contributing factor to the engineer's fatigue was undiagnosed OSA.10

NTSB also concluded that absence of positive train control (PTC) 11 was a contributing factor in each of the above train accidents.12 FRA agrees that PTC is an important technology that may prevent certain types of accidents in which OSA is a contributing factor. Nevertheless, PTC is not required on all track segments and any potential OSA regulations could have substantial positive impact at those locations. Potential OSA regulations could also have benefits even where PTC is fully implemented. For instance, compliance with potential OSA regulations could prevent incidents that PTC is not designed to prevent. Even in a situation when an engineer with OSA falls asleep and PTC functions as intended and stops a moving train before certain incidents,13 there may be delay costs to passengers and other trains from attending to the engineer that could be avoided by potential OSA regulations. The three examples of train accidents described above are illustrative of the consequences that could result from accidents that occur due to OSA.

The Department promotes the safety of America's transportation system through information, Web sites, regulations, guidelines, and policies. The Department's operating administrations regulate transportation safety following authorizations from the Congress. The authorities for determining and ensuring that transportation operators engaged in interstate commerce are physically qualified differ among the Department's operating administrations. Several administrations have been working for many years, in some instances along with advisory groups, to improve policies on medical fitness for duty of personnel in safety-critical functions. The sections below summarize the initiatives that several DOT operating administrations have taken to address OSA under their current authority.

Although this ANPRM covers how FMCSA and FRA will potentially treat OSA, FAA's history of its OSA screening of pilots is instructive. The FAA was created to provide the safe and efficient use of the national air space; that mission has evolved to providing the safest, most efficient aerospace system in the world. While the United States has an impressive safety record, the FAA continues to work with the aviation and medical communities to maintain medical certification standards to keep our skies safe. The FAA has always considered OSA a disqualifying condition, but has used its special issuance process 14 to certificate airman if the hazard of OSA was satisfactorily treated or mitigated.

In November 2013, FAA proposed guidance that would have required pilots with a body mass index (BMI) of 40 or more to be evaluated for OSA. Key aviation industry stakeholders, as well as members of Congress, expressed concerns about this single-factor enhanced screening as lacking a sufficient evidentiary basis, and thus being an example of overregulation by the FAA.

In response, FAA worked with stakeholders, to revise the guidance to address those concerns and issued new medical guidance to Aviation Medical Examiners (AMEs) on March 2, 2015, which balanced industry and Congressional concerns with the FAA and NTSB's safety concerns about pilots flying with OSA. Under the new guidance, AMEs screen airman for OSA using an integrated assessment of history, symptoms, and physical/clinical findings. If screening identifies a need for further evaluation, an OSA risk factor evaluation will be done by the AME at the time of the physical examination using the American Academy of Sleep Medicine (AASM) guidance provided in the Guide for Aviation Medical Examiners. 15

A pilot identified as being at risk for OSA will be issued a medical certificate, and shortly thereafter receive a letter from FAA's Federal Air Surgeon requesting that an OSA evaluation be completed within 90 days. The evaluation may be done by any physician (including the AME), not just a sleep medicine specialist. If the evaluating physician determines, using the AASM guidelines, that a laboratory sleep study or home study is warranted, it should be ordered at that time. The pilot will have 90 days (or longer under special circumstances) to accomplish this, as outlined in the Federal Air Surgeon's letter. The pilot may continue flying during the evaluation period until they have been diagnosed with OSA. A pilot is not allowed to fly once diagnosed with OSA, but upon submitting documentation of effective treatment to FAA, the FAA will then consider the pilot for a special issuance medical certificate, which allow the pilot to resume flying. More information on FAA guidance can be found at: https://www.faa.gov/news/fact_sheets/news_story.cfm?newsId=18156.

In 2000, FMCSA issued advisory criteria providing interpretive guidance to MEs concerning its physical qualifications standards. These advisory criteria are recommendations from FMCSA to assist MEs in applying the minimum physical qualification standards. The advisory criteria were published with the Federal Motor Carrier Safety Regulations as part of the medical examination report form in 49 CFR. 391.43 (Physical Qualification of Drivers; Medical Examination; Certificate, 65 FR 59363 (October 5, 2000)).

The advisory criterion for section 391.41(b)(5), which has been unchanged since 2000, provides the following guidance for MEs in making the determination whether a driver satisfies the respiratory standard:

Based on the above advisory criterion, it is clear that FMCSA considers OSA to be a respiratory dysfunction that interferes with oxygen exchange. As such, if a ME believes a driver's respiratory condition is, in any way, likely to interfere with the driver's ability to safely control and drive a commercial motor vehicle, the examiner may refer the driver to a specialist for further evaluation and therapy. This advisory criterion is helpful to MEs when the examiner has sufficient experience or information to recognize certain risk factors for OSA and when a driver tells the examiner that he has been diagnosed with OSA. Under these circumstances, MEs may consider referring the driver to a specialist for evaluation before issuing a ME's certificate, or request additional information from the driver and his treating healthcare professional about the management of the driver's OSA, respectively. However, the current guidance is not helpful if the ME does not have sufficient experience or information to suspect the driver may have OSA, or the driver does not share with the examiner any previous diagnosis that he has the condition.

In consideration of the limitations of the current advisory criterion, FMCSA tasked its MRB and MCSAC in 2011 to provide recommendations that FMCSA should consider to (1) develop new OSA standards for motor carriers, commercial vehicle drivers, and MEs and (2) determine whether drivers with this respiratory condition should receive an unrestricted two-year medical certificate to operate CMVs in interstate commerce. The MCSAC also recommended interim actions that FMCSA could take to help MEs address the issue before completing a rulemaking. A copy of the task statement, all presentations provided to the MCSAC, MRB, and the Committees' December 13, 2011, letter report to the FMCSA Administrator are included in the docket referenced at the beginning of this notice and also at the MCSAC Web page at https://www.fmcsa.dot.gov/advisory-committees/mcsac/2012-past-meetings.

During the deliberations of the MCSAC and MRB, experts indicated that studies 16 show that a using a BMI of 33 as a screening indicator for OSA is the value at which false positives and false negatives are minimized. A false positive would require a driver who does not have moderate-to-severe OSA to undergo a sleep study unnecessarily, while a false negative would fail to require a driver who actually has moderate-to-severe OSA to undergo a sleep study. The medical experts participating in the meeting indicated that approximately 75 percent of moderate-to-severe OSA cases would be correctly identified by requiring a sleep study for drivers with a BMI of 33 or greater; however, approximately 25 percent of drivers with moderate-to-severe OSA would be missed with this cutoff. Because the likelihood of OSA in patients with BMIs of 35 or greater rises to nearly 80 percent, the MCSAC and MRB agreed to use a BMI of 35 (rather than 33) in their interim advice to MEs screening drivers for referral to a specialist. A copy of the MCSAC and MRB discussion notes is included in the docket referenced at the beginning of this notice.

The chairs of the MRB and MCSAC considered their December 13, 2011, report as a first step towards recommendations for addressing OSA. The two committees completed more detailed recommendations in February 2012 to support a future notice-and-comment rulemaking. A copy of those recommendations is included in the docket referenced at the beginning of this notice.

Before FMCSA issued a notice requesting public comment on proposed regulatory guidance, several stakeholder groups expressed concerns about the agency addressing OSA through regulatory guidance, even on an interim basis. These groups requested that FMCSA pursue the matter through a notice-and-comment rulemaking process.

In 2013, Congress enacted Public Law 113-45 (127 Stat. 557, October 13, 2013, in a note to 49 U.S.C. 31305) directing FMCSA to issue any new or revised requirements concerning sleep disorders, including OSA, by rulemaking. Such requirements would include those for sleep apnea screening, testing, and treatment of CMV drivers.

On January 12, 2015, FMCSA issued a bulletin to healthcare professionals on the National Registry of Certified Medical Examiners regarding OSA. The bulletin reminded healthcare workers of the current physical qualifications standards and advisory criteria concerning the respiratory system, and specifically how those requirements apply to drivers that may have OSA. It encouraged MEs to explain to drivers the distinction between actions based on the current regulations and advisory criteria versus actions based on the MEs' professional judgment.

The FRA has taken various regulatory and non-regulatory actions to address the risk of accidents in which fatigue and/or OSA may be a contributing factor.

FRA enforces laws and has issued regulations regarding hours of service for certain railroad employees. See 49 U.S.C. chapter 211 and 49 CFR part 228. The hours of service (HOS) laws and regulations establish maximum hours of work and minimum hours of rest for train employees, signal employees, and dispatching service employees, as defined at 49 U.S.C. 21101.

HOS laws and regulations are a necessary component of mitigating risk associated with work schedules, including potential fatigue-related risks. However, HOS laws and regulations do not adequately mitigate risks associated with undiagnosed or inadequately treated OSA, even if the work schedules comply with the HOS laws and regulations, as they assume that the sleep that occurs during off-duty time is normal, restful sleep.

RSIA also requires certain railroads to establish a fatigue management plan. See 49 U.S.C. 20156(f). FRA is currently working with the Railroad Safety Advisory Committee (RSAC) to draft a regulation to implement this mandate. The RSIA requires plans to be “designed to reduce the fatigue experienced by safety-related railroad employees and to reduce the likelihood of accidents, incidents, injuries, and fatalities caused by fatigue.” Id. at section 20156(f)(1). Further, the RSIA requires a railroad to consider the need to include in its fatigue management plan, as applicable, “opportunities for identification, diagnosis, and treatment of any medical condition that may affect alertness or fatigue, including sleep disorders.” Id. at section 20156(f)(3)(B). However, RSIA does not specifically mandate that the regulation require railroads to screen and evaluate safety-related railroad employees for OSA or other sleep disorders.

On September 21, 2004, FRA issued Safety Advisory 2004-04 to alert the railroad community, and especially those employees with safety sensitive duties, to the danger associated with degradation of performance resulting from sleep disorders that are undiagnosed or not successfully treated. 69 FR 58995 (Oct. 1, 2004). FRA recommended that the railroad community take the following actions:

1. Establish training and educational programs to inform employees of the potential for performance impairment as a result of fatigue and sleep related issues;

2. Develop standardized screening tools for diagnosis, referral, and treatment of sleep disorders (especially sleep apnea);

3. Develop rules to encourage voluntary reporting of sleep disorders by employees with safety sensitive duties;

4. Implement policies that would prohibit employees in safety sensitive positions who have incapacitation or performance-impairing medical conditions related to sleep from performing any safety sensitive duties until the medical condition appropriately responds to treatment; and

5. Implement policies to: (a) Promote self-reporting; (b) encourage participation in evaluation and treatment; and (c) establish dispute resolution to resolve any issues regarding fitness of those employees who have reported sleep-related issues.

In September 2006, the RSAC established the Medical Standards Working Group to develop standards for identifying conditions that could lead to sudden incapacitation or impairment of safety-critical personnel. The Working Group established a Physicians Task Force that developed draft medical standards and protocols. FRA put the Medical Standards Working Group on hiatus due to the requirement to focus on activities mandated in the Rail Safety Improvement Act of 2008.

As part of its non-regulatory efforts to address fatigue, FRA sponsors the Railroaders' Guide to Healthy Sleep Web site.17 This Web site is set up to disseminate educational information to railroad employees and their families about sleep disorders, the relevance of healthy sleep to railroad safety, and information about improving the quality of the railroaders' sleep. The Web site was developed in conjunction with the Division of Sleep Medicine at Harvard Medical School, WGBH Educational Foundation, and Volpe—The National Transportation Systems Center.

Based on the potential severity of OSA-related transportation incidents and accidents, and the varied, non-regulatory, OSA-related actions taken by the Department's Operating Administrations to date, the Agencies are considering taking regulatory action to ensure consistency in addressing the safety issue presented by transportation workers with safety sensitive duties who are at risk for OSA.

The Agencies seek information from interested parties regarding OSA, in order to better inform their decision on whether to take regulatory action and, if so, how to craft the most effective and efficient regulation to address the potential safety risks associated with OSA.

The Agencies request public comment on the questions below. In your response, please provide supporting materials and identify your interest in this rulemaking, whether in the transportation industry, medical profession, or other.

1. What is the prevalence of moderate-to-severe OSA among the general adult U.S. population? How does this prevalence vary by age?

2. What is prevalence of moderate-to-severe OSA among individuals occupying safety sensitive transportation positions? If it differs from that among the general population, why does it appear to do so? If no existing estimates exist, what methods and information sources can the agencies use to reliably estimate this prevalence?

3. Is there information (studies, data, etc.) available for estimating the future consequences resulting from individuals with OSA occupying safety sensitive transportation positions in the absence of new restrictions? For example, does any organization track the number of historical motor carrier or train accidents caused by OSA? With respect to rail, how would any OSA regulations and the current PTC requirements interrelate?

4. Which categories of transportation workers with safety sensitive duties should be required to undergo screening for OSA? On what basis did you identify those workers?

5. What alternative forms and degrees of restriction could FMCSA and FRA place on the performance of safety-sensitive duties by transportation workers with moderate-to-severe OSA, and how effective would these restrictions be in improving transportation safety? Should any regulations differentiate requirements for patients with moderate, as opposed to severe, OSA?

6. What are the potential costs of alternative FMCSA/FRA regulatory actions that would restrict the safety sensitive activities of transportation workers diagnosed with moderate-to-severe OSA? Who would incur those costs? What are the benefits of such actions and who would realize them?

7. What are the potential improved health outcomes for individuals occupying safety sensitive transportation positions and would receive OSA treatment due to regulations?

8. What models or empirical evidence is available to use to estimate potential costs and benefits of alternative restrictions?

9. What costs would be imposed on transportation workers with safety sensitive duties by requiring screening, evaluation, and treatment of OSA?

10. Are there any private or governmental sources of financial assistance? Would health insurance cover costs for screening and/or treatment of OSA?

11. What medical guidelines other than the AASM FAA currently uses are suitable for screening transportation workers with safety sensitive duties that are regulated by FMCSA/FRA for OSA? What level of effectiveness are you seeing with these guidelines?

12. What were the safety performance histories of transportation workers with safety sensitive duties who were diagnosed with moderate-to-severe OSA, who are now successfully compliant with treatment before and after their diagnosis?

13. When and how frequently should transportation workers with safety sensitive duties be screened for OSA? What methods (laboratory, at-home, split, etc.) of diagnosing OSA are appropriate and why?

14. What, if any, restrictions or prohibitions should there be on a transportation workers' safety sensitive duties while they are being evaluated for moderate-to-severe OSA?

15. What methods are currently employed for providing training or other informational materials about OSA to transportation workers with safety sensitive duties? How effective are these methods at identifying workers with OSA?

16. What qualifications or credentials are necessary for a medical practitioner who performs OSA screening? What qualifications or credentials are necessary for a medical practitioner who performs the diagnosis and treatment of OSA?

17. With respect to FRA should it use Railroad MEs to perform OSA screening, diagnosis, and treatment?

18. Should MEs or other Agencies' designated medical practitioners impose restrictions on a transportation worker with safety sensitive duties who self-reports experiencing excessive sleepiness while performing safety sensitive duties?

19. What should be the acceptable criteria for evaluating the effectiveness of prescribed treatments for moderate-to-severe OSA?

20. What measures should be used to evaluate whether transportation employees with safety sensitive duties are receiving effective OSA treatment?

Under E.O. 12866, “Regulatory Planning and Review” (issued September 30, 1993, published October 4 at 58 FR 51735, and discussed above in the “Background” section), as supplemented by E.O. 13563 and DOT policies and procedures, if a regulatory action is determined to be “significant,” it is subject to Office of Management and Budget (OMB) review. E.O. 12866 defines “significant regulatory action” as one likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal government or communities.

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency.

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O.

The Department has determined this ANPRM is a “significant regulatory action” under E.O. 12866, and significant under DOT regulatory policies and procedures due to significant public interest in the legal and policy issues addressed. Therefore, this notice has been reviewed by OMB.

NHTSA is issuing this NPRM as part of the agency's ongoing effort to harmonize vehicle safety standards under the Economic Commission for Europe 1998 Global Agreement (“1998 Agreement”). The efforts of the U.S. and other contracting parties to the 1998 Agreement culminated in the establishment of GTR No. 13, “Hydrogen and fuel cell vehicles.” NHTSA voted in June 2013 in favor of establishing GTR No. 13. In this NPRM, we are proposing requirements based on the electrical safety requirements of GTR No. 13. NHTSA will initiate rulemaking in the future on other aspects of GTR No. 13 directly pertaining to the fuel system integrity of hydrogen fuel cell vehicles.

One purpose of FMVSS No. 305 is to reduce deaths and injuries from electrical shock. The standard requires vehicles with high voltage sources to meet certain performance criteria to protect vehicle occupants, rescue workers and others who may come in contact with the vehicle after a crash. Among other things, FMVSS No. 305 requires that after a crash, high voltage sources in a vehicle are either (a) electrically isolated from the vehicle's chassis or (b) their voltage is below specified levels considered safe from electric shock hazards. Since the physiological impacts of direct current (DC) are less than those of alternating current (AC), the standard specifies lower minimum electrical isolation requirements for certain DC components (100 ohms/volt) than for AC components (500 ohms/volt).

GTR No. 13 also has requirements intended to reduce deaths and injuries from electrical shock. Unlike FMVSS No. 305, GTR No. 13 has requirements that reduce the risk of harmful electric shock during normal vehicle operation. This NPRM proposes to adopt those requirements to expand FMVSS No. 305's performance requirements beyond post-crash conditions. In addition, while the various post-crash compliance options in GTR No. 13 are similar to those in FMVSS No. 305, GTR No. 13 includes a compliance option for electrical vehicle safety that prevents direct and indirect contact of high voltage sources by way of “physical barriers.” NHTSA is now proposing to amend FMVSS No. 305 to permit a physical barrier compliance option.1

NHTSA tentatively believes that the by-product of adopting a physical barrier option would be more than harmonizing vehicle standards. Enhanced design innovation, reduced CO2 emissions and increased fuel economy would likely result. This proposal would facilitate the introduction of 48 volt mild hybrid technologies and hydrogen fuel cell vehicles, and responds not only to GTR No. 13 but also to petitions for rulemaking from Toyota and the Alliance.

Petitioner Toyota believes that an additional compliance option that includes elements of the physical barrier option in GTR No. 13 is needed to allow hydrogen fuel cell vehicles (HFCVs) to be offered for sale in the U.S.2 HFCVs and other electric powered vehicles operate with their DC high voltage sources (e.g. high voltage battery) connected to the AC high voltage sources (e.g. electric motor). In a moderate to severe crash (e.g., crash speeds at which an air bag would deploy), electric powered vehicles are generally designed with an automatic disconnect mechanism that activates and breaks the conductive link between the electrical energy storage system and the rest of the power train. Under these crash conditions in which an automatic disconnect mechanism activates, Toyota states that its HFCVs would be able to meet the electrical safety requirements of FMVSS No. 305. However, in low speed crashes where the automatic disconnect mechanism is not designed to activate so that the vehicle can be driven away after a minor crash (fender-bender), Toyota states that its HFCVs would not be able to meet the electrical safety requirements in FMVSS No. 305. The petitioner believes that the additional compliance option requested in its petition would solve this problem and would not cause any reduction in the level of electrical safety now required by FMVSS No. 305.

Petitioner Alliance requests a physical barrier compliance option to facilitate the production of 48 volt mild hybrid technologies as well as hydrogen fuel cell vehicles. The petitioner asks NHTSA to amend FMVSS No. 305 to adopt a physical barrier option incorporated in the Society of Automotive Engineers (SAE) J1766 Jan 2014,3 section 5.3.4, for 48 volt mild hybrid systems. The Alliance believes that the provisions for physical barriers in section 5.3.4 incorporate the requirements of GTR No. 13 and provide for physical barriers that ensure equal levels of safety as that afforded by the current FMVSS No. 305 electrical safety requirements.

The petitioner states that while vehicles with 48 volt mild hybrid systems use mostly low-voltage components that do not present any danger of harmful electric shock, AC voltage sources contained within the system can exceed the 30 volt threshold in FMVSS No. 305 for consideration as a high voltage source. Since these systems are grounded to the vehicle chassis, they cannot meet FMVSS No. 305's existing electrical isolation option. The petitioner states that while it is feasible to design a 48 volt mild hybrid system that is isolated from the chassis and meets FMVSS No. 305's electrical isolation requirements, such designs involve more complexity, higher consumer costs, and higher mass resulting in reduced fuel economy and increased emissions. The petitioner believes that these penalties are inappropriate when there would be no incremental safety benefit gained beyond that associated with SAE J1766's physical barrier option.

NHTSA has undertaken this rulemaking after carefully and extensively examining the safety issues. The agency previously decided against consideration of a physical barrier option earlier in the history of FMVSS No. 305, when our knowledge about the option was limited.4 Commenters to an NPRM to upgrade electrical shock protection requirements had asked NHTSA to adopt the option in the final rule, for reasons similar to those provided by petitioners Toyota and the Alliance. NHTSA declined, citing concerns about the lack of notice for the provision, the absence of developed test procedures to ensure protection from indirect contact, and uncertainty as to whether the option would sufficiently account for indirect contact failure modes. NHTSA then decided to undertake a research program (later known as the Battelle study, discussed below in this preamble) to better understand the issues related to a physical barrier option for electrical safety.

Since that decision in 2010, a number of developments led to today's proposal. GTR No. 13 was established, a product of shared data and knowledge from governing bodies and international experts around the world. The Battelle study was completed and the physical barrier countermeasure design was made more robust in response to its findings, with SAE revising J1766 in January 2014 to set forth more protective safety practices than it had before to address remote albeit lingering concerns. Importantly, there have now been years of worldwide recognition of the physical barrier option as an acceptable means of providing electrical safety in electric powered vehicles, with years of experience in design labs and in the field showing no evidence of associated safety problems. HFCVs, 48 volt mild hybrid technologies, and other vehicle designs have become a reality, and with them abundant potential for the development of electrical technologies that a physical barrier option in FMVSS No. 305 can facilitate, expedite and safeguard.

We estimate that adopting this NPRM would come at essentially no cost to consumers in the U.S. This proposal closely mirrors the electrical safety provisions of GTR No. 13, which have been implemented by manufacturers in this country.

NHTSA believes that this NPRM would improve the level of safety afforded to the public. Adopting the provisions from GTR No. 13 that reduce the risk of harmful electric shock during normal vehicle operation would improve FMVSS No. 305 by expanding its performance requirements beyond post-crash conditions. The proposed requirements would provide post-crash compliance options for new power train configurations that ensure that those configurations provide a comparable level of post-crash safety compared to existing electric vehicles.

The proposed amendments are summarized as follows. In furtherance of implementing GTR No. 13 and in response to the petitions for rulemaking—

a. This NPRM proposes to add electrical safety requirements for vehicle performance during everyday (“normal”) vehicle operations (as opposed to during and after a crash), to mitigate electric shock due to loss in electrical isolation and direct or indirect contact of high voltage sources. The electrical safety requirements during normal vehicle operations would include requirements for:

1. Direct contact protection from high voltage sources

2. Indirect contact protection from high voltage sources

3. Electrical isolation of high voltage sources

4. Electrical isolation monitoring system for DC high voltage sources on fuel cell vehicles.

5. Electrical safety during charging involving connecting the vehicle to an external electric power supply:

6. Mitigating driver error by—

b. This NPRM also proposes to amend FMVSS No. 305's post-crash electrical safety requirements. The proposed post-crash electrical safety requirements include:

FMVSS No. 305 currently establishes requirements to reduce deaths and injuries during and after a crash that occurs because of electrolyte spillage from electric energy storage devices, intrusion of electric energy storage/conversion device into the occupant compartment, and electrical shock. Among other things, FMVSS No. 305 requires that during and after the crash tests specified in the standard, high voltage sources in the vehicle must be either (a) electrically isolated from the vehicle's chassis,8 or (b) their voltage is below specified levels considered safe from electric shock hazards.9

Many of these electrical shock protection requirements were established by a June 14, 2010 final rule (75 FR 33515) that revised the standard to align it more closely with the April 2005 version of SAE J1766. Commenters to the NPRM preceding the June 14, 2010 final rule (viz., the Alliance and Global Automakers) requested another electrical safety compliance option, called the “physical barrier option,” for providing greater flexibility to allow introduction of advanced power train technologies. In the physical barrier option, high voltage sources are enclosed in physical barriers (electrical protection barriers) that do not permit entrance of a finger probe into the enclosure after the crash test to ensure no direct contact with high voltage sources. This option also requires the physical barriers to be conductively connected to the electric chassis to ensure no electric shock due to indirect contact in the event of loss in isolation of a high voltage source.

In the June 14, 2010 final rule, NHTSA declined to adopt the physical barrier option, citing concerns about the sufficiency of notice provided for the provision, the absence of developed test procedures to ensure protection from indirect contact, and uncertainty as to whether the option would sufficiently account for indirect contact failure modes. NHTSA stated that it would undertake a research program (the Battelle study) to better understand the issues related to a physical barrier option for electrical safety.

The United States is a contracting party to the “1998 Agreement” (the Agreement concerning the Establishing of Global Technical Regulations for Wheeled Vehicles, Equipment and Parts which can be fitted and/or be used on Wheeled Vehicles). This agreement entered into force in 2000 and is administered by the UN Economic Commission for Europe's (UN ECE's) World Forum for the Harmonization of Vehicle Regulations (WP.29). The purpose of this agreement is to establish Global Technical Regulations (GTRs).

GTR No. 13, “Hydrogen fuel cell vehicles,” addresses hydrogen fuel cell vehicle technology. NHTSA closely collaborated with experts from contracting parties to the 1998 Agreement, particularly Germany and Japan, to develop a GTR for hydrogen fueled vehicles that would establish levels of safety that are equivalent to or exceeds those for conventional gasoline fueled vehicles. The collaborative effort in this process led to the establishment of GTR No. 13 in June 2013.

The U.S. voted on June 27, 2013 in favor of establishing GTR No. 13. In voting yes to establishing the GTR, NHTSA is obligated to “submit the technical Regulation to the process” used in the U.S. to adopt the requirement into our law or regulation. By issuance of this NPRM, NHTSA is initiating the process for considering adoption of GTR No. 13.

Under the terms of the 1998 Agreement, NHTSA is not obligated to adopt the GTR after initiating this process. In deciding whether to adopt a GTR as an FMVSS, we follow the requirements for NHTSA rulemaking, including the Administrative Procedure Act, the National Highway and Motor Vehicle Safety Act (Vehicle Safety Act), Presidential Executive Orders, and DOT and NHTSA policies, procedures and regulations. Among other things, FMVSSs issued under the Vehicle Safety Act “shall be practicable, meet the need for motor vehicle safety, and be stated in objective terms.” 49 U.S.C. 30111.

This NPRM does not propose the entirety of GTR No. 13 at this time. This document only addresses the electrical safety requirements in GTR No. 13 (i.e., the electrical isolation requirements, physical barrier requirements, etc.). GTR No. 13 also addresses hydrogen fuel system and fuel container integrity requirements and the agency's plan is to issue a separate proposal to seek comment on incorporating those portions of GTR No. 13 into the relevant FMVSSs.

Hydrogen fueled fuel cell vehicles have an electric drive-train powered by a fuel cell that generates electric power electrochemically using hydrogen. The hydrogen is electrochemically combined with oxygen (from air) within the fuel cell system to produce high-voltage electric power. The electric power is supplied to the electric drive motors and/or used to charge batteries and capacitors. HFCVs may also be equipped with batteries to supplement the output of fuel cells and may also recapture energy during stopping through regenerative braking, which recharges batteries and thereby improves efficiency.

The fuel cell provides DC power while the drive motors typically operate on AC. Therefore, the power train has: (a) Inverters to convert DC power to AC to run the motors and (b) converters to convert AC power generated in the drive motor during regenerative braking to DC to store energy in the batteries. In many respects, the electric power train of an HFCV is similar to that of electric and hybrid electric vehicles. GTR No. 13, in part, specifies electrical safety requirements during normal vehicle operation and after a crash test, to protect against electric shock in the event of a failure in the high voltage propulsion system.

In general, the portions of GTR No. 13 that are relevant to this rulemaking are the electric safety requirements intended to protect against the potential for electric shock during (a) normal vehicle operation, and (b) after a crash. We discuss these requirements in GTR No. 13 in the sections below.

These performance requirements in GTR No. 13 are requirements intended for protecting vehicle occupants (and others that may interact with the vehicle) against electric shock during normal vehicle operation.10 For the purposes of the GTR, normal vehicle operations include those during driving and charging.

The GTR requirements apply to all high voltage sources (electric components contained or connected to the electric power train that have a working voltage greater than 30 VAC or 60 VDC). It requires these high voltage sources to have all four of the following measures to protect against electric shock during normal vehicle operations: (1) Prevent direct contact of high voltage sources (those operating with voltage greater than 30 VAC or 60 VDC); (2) prevent indirect contact of high voltage sources; (3) electrically isolate the high voltage sources from the electric chassis (500 ohms/volt or higher for AC and 100 ohms/volt or higher for DC sources); and (4) electrical isolation monitoring system for HFCVs that warns the driver in the event of loss in isolation.

The GTR also has the following measures to reduce driver errors that may result in potential unsafe conditions: (1) Indication to the driver when the vehicle is in possible active driving mode at startup and when the driver is leaving the vehicle, and (2) prevent vehicle movement by its own propulsion system when the vehicle charging system is connected to the external electric power supply.

For protection against direct contact with high voltage sources, the GTR has different requirements based on the location of the high voltage source (i.e., if it is in the passenger or luggage compartment of the vehicle or not).

The GTR requires high voltage sources inside the passenger compartment or luggage compartment to be enclosed in protection systems such as solid insulators, electrical protection barriers, and enclosures that cannot be opened, disassembled, or removed without the use of tools and that provide protection degree IPXXD. Protection degree IPXXD is an International Electrotechnical Commission (IEC) specification for protection from direct contact of high voltage sources. IPXXD protection is verified when a standard probe (rigid test wire shown in Figure 1), 100 millimeters (mm) long and 1 millimeter (mm) in diameter, does not contact high voltage components when probed to enter an electrical protection barrier or enclosure.11

For high voltage sources not in passenger or luggage compartments,12 the GTR requires that they be enclosed in protection systems such as solid insulators, electrical protection barriers, and enclosures that cannot be opened, disassembled, or removed without the use of tools, and that provide a protection degree of IPXXB (as opposed to IPXXD, referenced above). Protection degree IPXXB is an IEC specification for protection from direct contact of high voltage sources. IPXXB protection is verified when a standard probe (resembling a small human finger), 80 mm long and 12 mm in diameter, does not contact high voltage components when probed to enter an electrical protection barrier or enclosure.13 (See Figure 2 below.)

In addition to barriers preventing direct physical contact with high voltage sources, GTR No. 13 also requires protections for the “service disconnect.” 14 These provisions protect emergency personnel, persons performing service/maintenance on the vehicle, and vehicle occupants. The GTR requires that a service disconnect (which can be opened, disassembled or removed without tools) be enclosed by protection systems with protection degree IPXXB when the service disconnect is opened, disassembled, or removed.

Further, the GTR requires that high voltage sources be labeled using the symbol shown in Figure 3, below. The interior of the symbol is yellow and the border and arrow symbol are black. This requirement aims to provide a standardized warning regarding the presence of high voltage sources within an enclosure that can be physically accessed, opened or removed without the use of tools. The GTR specifies that the labels need to be on or near electric energy storage/conversion devices and on electrical protection barriers or enclosures of high voltage sources that can be physically accessed, opened, or removed without the use of tools and that are not located underneath the vehicle floor. For connecters of high voltage sources, the GTR makes this requirement optional.

In the same vein, the GTR requires cables to have a standardized warning that high voltage cables are present. The GTR requires that cables for high voltage sources, which are not located within enclosures, must have an orange outer covering for identification.

Indirect contact of high voltage sources 15 may occur when a high voltage source experiences a loss in electrical isolation and the physical barrier or enclosure gets electrically energized. This type of contact could also lead to electrical shock. To address this concern, the GTR requires, first, that exposed conductive parts (parts which may become electrically energized under electrical isolation failure and which can be contacted by a human, such as electrical protection barriers and enclosures) be conductively connected to the electrical chassis such that the resistance between all exposed conductive parts and the electrical chassis is less than 0.1 ohms when there is current flow of at least 0.2 amperes (A).16 This would ensure that in the event of loss in electrical isolation, no dangerous voltage potentials are produced between exposed conductive parts and the electrical chassis, and therefore very low levels of current would flow through a human body contacting different parts of the vehicle.17

Second, GTR No. 13 requires that vehicles whose rechargeable energy storage systems are charged by conductively connecting to an external grounded electric power supply have a device that conductively connects the electrical chassis to the earth ground during charging. This ensures that if there is a loss in electrical isolation of a high voltage source during charging and the vehicle chassis is contacted by a human, the magnitude of current flowing through the person is very low and in the safe zone.18

GTR No. 13 affords different electrical isolation requirements for AC and DC high voltage sources based on whether they are conductively isolated from each other or conductively linked together.

For AC and DC high voltage sources that are conductively isolated from each other, GTR No. 13 requires isolation resistance between the high voltage source and the electrical chassis to be a minimum value of 100 ohms/volt of the working voltage for DC high voltage sources, and a minimum value of 500 ohms/volt of the working voltage for AC high voltage sources. This requirement is similar to the post-crash electrical isolation requirement currently in FMVSS No. 305. It ensures that in the event high voltage sources are contacted, the current flowing through the body is less than or equal to 10 mA DC or 2 mA AC—which is considered to be safe.19

For AC and DC high voltage sources that are conductively connected, GTR No. 13 affords two options. The first option is the vehicle may maintain an isolation resistance between the high voltage sources and the electrical chassis at no less than 500 ohms/volt of the working voltage. The second option is it may provide an isolation resistance between the high voltage sources and the electrical chassis of no less than 100 ohms/volt of the working voltage and provide physical barrier protection for the AC high voltage sources to prevent both direct and indirect contact, as discussed above. (Note that a “physical barrier” approach would be a new concept in FMVSS No. 305.)

In addition, GTR No. 13 specifies electrical isolation requirements for charging electric vehicles whose rechargeable energy storage system are charged by conductively connecting to an external power supply. GTR No. 13 requires that the isolation resistance between the electrical chassis and high voltage sources conductively connected to the vehicle inlet which connects to the external power supply to be at least 1 million (M) ohms when the charge coupler is disconnected. This requirement is in accordance with IEC61851-1-2010 20 and International Standards Organization (ISO) 6469-2 21 which prescribe electrical isolation for electric vehicles that connect to the power grid for charging. A typical minimum allowable isolation requirement for a grounded product connected to the power grid is 1000 ohms/volt, which computes to 1M ohms.

GTR No. 13 also contains provisions for monitoring the electrical isolation under certain conditions. In fuel cell vehicles, GTR No. 13 requires DC high voltage sources (other than the coupling system for charging) to have an on-board electrical isolation monitoring system, together with a warning to the driver if the isolation resistance drops below the minimum required value of 100 ohms/volt. FMVSS No. 305 specifies a similar requirement except that FMVSS No. 305 applies this provision to vehicles that are certified to the 100 ohms/volt electrical isolation option 22 (rather than to fuel cell vehicles specifically).

GTR No. 13 also has provisions for mitigating the likelihood of driver error in operating electric vehicles. First, GTR No. 13 requires that at least a momentary indication be given to the driver when the vehicle is in possible active driving mode.23 Second, when leaving the vehicle, the driver shall be informed by an optical or audible signal if the vehicle is still in possible active driving mode. The third requirement is that for vehicles where the on-board rechargeable energy storage/conversion device can be charged externally, vehicle movement by its own propulsion system shall not be possible when the external electric power supply is physically connected to the vehicle inlet.

The first requirement does not apply to vehicles with an internal combustion engine that directly or indirectly provides the vehicle's propulsion on startup. Since electric powered vehicles operate quietly, an indication of the vehicle in possible active driving mode would assist the driver in reducing operational errors that could have safety implications. The third requirement prevents the charger from getting ripped out of the vehicle inlet during charging that could cause electrical arcing.

The post-crash 24 electrical safety requirements in GTR No. 13 apply to all high voltage sources (electric components contained or connected to the electric power train that have a working voltage greater than 30 VAC or 60 VDC). GTR No. 13 does not specify the type of crash test and how it is conducted. This is left to each contracting party to develop appropriate crash tests. After the crash test, to provide adequate protection against electric shock, GTR No. 13 affords three potential options that a vehicle manufacturer may use to protect against potential human contact with high voltage sources. GTR No. 13 specifically gives contracting parties the choice not to provide the physical barrier option in their final domestic regulation.

Reducing the high voltage sources' voltage to a level below what is considered a “high voltage source” means there is no further need to protect against electrical shock from those sources. Thus, in this option, GTR No. 13 requires that the voltages of each high voltage source be reduced to less than or equal to 30 VAC or 60 VDC within 60 seconds after the impact. A version of this option for electrical safety is currently in FMVSS No. 305.

The physical barrier option protects against electrical shock by preventing any human contact (direct or indirect) with the high voltage sources. The physical barrier option for post-crash is similar to the physical barrier option that GTR No. 13 affords for its normal vehicle operation requirement. The requirements state that (post-crash) the vehicle needs to prevent both direct and indirect human contact with high voltage sources through the use of: (1) Physical barriers (i.e., prevent a finger probe test device from contacting any high voltage source); and (2) low resistance conductive connection of the physical barriers to the electrical chassis (i.e., the resistance between all exposed conductive parts and the electrical chassis has to be less than 0.1 ohms when there is a current flow of at least 0.2 A 26 ). The only major difference is that GTR No. 13 uses protection degree IPXXB (i.e., the IPXXB finger probe) for its post-crash requirements (rather than IPXXD).27 As noted earlier, FMVSS No. 305 currently contains no similar provision for electric shock protection through physical barriers.

This option protects against electric shock by ensuring that a sufficient level of electrical isolation resistance is provided for the high voltage source. GTR No. 13 provides two different sets of requirements (based on whether the vehicle's AC and DC high voltage sources are conductively connected) for vehicles electing to use this option to protect against electric shock.

If the AC and DC high voltage sources are conductively isolated from each other, then the minimum electrical isolation of a high voltage source to the chassis is 500 ohms/volt for AC components and 100 ohms/volt for DC components of the working voltage.

If AC and DC high voltage sources are conductively connected, GTR No. 13 requires that electrical isolation of AC and DC high voltage sources be no less than 500 ohms/volt of the working voltage, or the electric isolation of those sources be no less than 100 ohms/volt provided that the AC high voltage sources (in addition to the minimum 100 ohms/volt electrical isolation) meet the reduced voltage level requirements discussed above (first option), or meet the physical protection requirements discussed above in the second option.

We note that while currently FMVSS No. 305 contains different requirements for AC high voltage sources and DC high voltage sources, it does not distinguish requirements based on whether the AC and DC high voltage sources are conductively linked. Thus, while the requirements in GTR No. 13 for AC and DC sources that are not conductively connected are the same as those currently in FMVSS No. 305, the alternative requirements for conductively connected AC and DC sources are not.

This NPRM proposes to add electrical safety requirements during normal vehicle operation in GTR No. 13 into FMVSS No. 305. The proposal also adds a modified version of physical barrier protection that is specified in GTR No. 13 as a compliance option for meeting post-crash electrical safety requirements. However, this NPRM does not propose to adopt all the specifications in GTR No. 13. The differences in electrical safety requirements and associated test procedures in the proposal and that in GTR No. 13, along with an explanation for these differences, are provided below. Comments are requested on NHTSA's views.

This NPRM proposes to adopt GTR No. 13's physical barrier protection requirement during normal vehicle operation for direct contact. However, for indirect contact protection, we propose to use the proposed post-crash indirect contact protection requirements described above (which include two additional requirements described above in addition to that specified in GTR No. 13).

GTR No. 13 considers indirect contact protection requirements during normal vehicle operations to be met if a galvanic connection 28 has been established by welding between exposed conductive parts and the electrical chassis.

For conditions where the DC and AC high voltage sources are connected during normal vehicle operations, GTR No. 13 permits the AC high voltage sources to have a minimum electrical isolation of 100 ohms/volt provided the AC high voltage sources have either: (a) Double or more layers of solid insulators or electrical protection barriers that meet the requirements for indirect contact protection; or (b) Mechanically robust protections that have sufficient durability over vehicle service life such as motor housings, electronic converter cases or connectors.

These methods of verification consist of mere visual inspection and do not provide sufficient objectivity for use in an FMVSS. Therefore, the agency's proposal does not consider indirect contact protection requirements to be met if galvanic connection has been established between exposed conductive parts and the electric chassis. The agency is also not proposing visual inspection methods to permit AC high voltage sources that are connected to a DC high voltage source to have minimum electrical isolation of 100 ohms/volt during normal vehicle operation.

GTR No. 13 requires marking (yellow high voltage symbol) for enclosures and barriers of high voltage sources (electrical protection barriers) that can be physically accessed, opened, or removed without the use of tools. These markings are not required for electrical protection barriers located underneath the vehicle floor.

NHTSA tentatively concludes that the exclusion is without merit. GTR No. 13 does not provide a justification for exempting electrical protection barriers located underneath the vehicle floor from the high voltage marking requirement. There is also no definition of “vehicle floor” in GTR No. 13. NHTSA does not believe electrical protection barriers located under the vehicle floor should be excluded because it is possible that the high voltage sources enclosed by these barriers may be accessed in a rollover crash or during vehicle maintenance.

GTR No. 13 specifies direct contact protection requirements for high voltage connectors separately. Per GTR No. 13, connectors do not need to meet IPXXB protection if they are located underneath the vehicle floor and are provided with a locking mechanism, or require the use of tools to separate the connector, or the voltage reduces to below 30 VAC or 60 VDC within one second after the connector is separated. NHTSA does not believe connectors of high voltage sources should be excluded. If connectors are high voltage sources and if they can be accessed, opened, or removed without the use of tools, regardless of whether they are located under the floor, they should be required to meet the same requirements for voltage markings and direct contact protection as electric protection barriers. Additionally, the agency notes that “vehicle floor” and “connector” are not defined in GTR No. 13. Therefore, NHTSA would not exclude connectors of high voltage sources.

GTR No. 13 specifies that individual contracting parties of the 1998 agreement may elect to propose the physical barrier protection from direct and indirect contact of high voltage sources and live parts. According to GTR No. 13, for protection against direct contact, high voltage sources and live parts are required to have protection degree IPXXB. For protection against indirect contact, GTR No. 13 requires that the resistance between all exposed conductive parts and electrical chassis be lower than 0.1 ohm when there is current flow of at least 0.2 A.

The physical barrier protection option in this NPRM includes the same provisions for direct and indirect contact protection as that in GTR No. 13 but adds two additional requirements for indirect contact protection (from SAE J1766 January 2014).

This first additional requirement is that the resistance between any two simultaneously reachable exposed conductive parts of the electrical protection barriers that are less than 2.5 meters from each other is less than 0.2 ohms. This additional requirement protects against indirect contact of high voltage sources when two electrical protection barriers are contacted simultaneously. The second additional requirement is that the voltages between an electrical protection barrier enclosing a high voltage source and other exposed conductive parts are less than or equal to 30 VAC or 60 VDC. This additional requirement is included in SAE J1766 January 2014 to provide additional protection from indirect contact of high voltage sources, addressing the issues raised in the Battelle research of the physical barrier protection option.

GTR No. 13 states that a high voltage source is considered to have post-crash indirect contact protection if the electrical protection barrier enclosing the high voltage source has a galvanic connection to the chassis by welding. This method of verification is a mere visual inspection and lacks the objectivity needed for an FMVSS. This NPRM does not include this method of verification and instead proposes to use the test procedure in GTR No. 13 whereby a current of 0.2 A is passed through the connection to determine its resistance.

This NPRM proposes to adopt the physical barrier protection requirement for direct contact specified in GTR No. 13 for both post-crash and during normal vehicle operation. However, for indirect contact protection, the proposal uses the proposed post-crash indirect contact protection requirements described above (which include two additional requirements described above in addition to that specified in GTR No. 13).

FMVSS No. 305's test procedure for measuring electrical isolation of high voltage sources is similar to that in GTR No. 13. However, GTR No. 13 permits the crash tests to be conducted without energizing the electric power train while FMVSS No. 305 does not. In conditions where the high voltage sources are not energized during the crash test, GTR No. 13 permits measuring electrical isolation resistance of high voltage sources by other means, including using a megohmmeter.29 Yet, GTR No. 13 does not specify a test procedure to measure isolation resistance using a megohmmeter.

NHTSA is not proposing to conduct the crash test without energizing the electric power train and so is not permitting the use of the megohmmeter. NHTSA stated its position on this matter in final rules published on June 14, 2010 (75 FR 33515), July 29, 2011 (76 FR 45436), and January 16, 2015 (80 FR 2320). In the January 16, 2015 final rule, NHTSA noted that the agency's research on the feasibility of using a megohmmeter for measuring electrical isolation presented 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).

Additionally, electrical isolation resistance measurement with a megohmmeter is only possible when the electrical power train is not energized, such as when an inert gas is used in hydrogen containers of a fuel cell vehicle. NHTSA will address the issue of the use of inert gas in hydrogen containers of fuel cells vehicles when conducting crash tests in a future proposal to incorporate into FMVSSs the fuel system and fuel container integrity requirements of hydrogen fuel cell vehicles in GTR No. 13. The agency will address in that rulemaking the use of alternative methods of measuring isolation resistance in conditions where the electric power train is not energized in crash tests.

FMVSS No. 305 specifies that all post-crash voltage measurements for determining voltage and electrical isolation of high voltage sources with respect to the electric chassis be made after a minimum of 5 seconds after the vehicle comes to rest following impact. GTR No. 13 specifies that for determining post-crash electrical isolation of high voltage sources, the voltage measurements be made after a minimum of 5 seconds after “impact.” GTR No. 13 also specifies that for determining post-crash voltage (for assessing compliance with the low voltage option), the voltage measurements be made after a minimum of 5 seconds and no later than 60 seconds after impact.

The agency is not proposing to change the timing of voltage measurement post-crash in FMVSS No. 305 to harmonize with GTR No. 13. The “after impact” interval specified in GTR No. 13 appears less objective than FMVSS No. 305's measure and adopting the GTR No. 13 specified time for post-crash voltage measurement may reduce the objectivity of the test. Further, all-in-all we believe this difference in the timing of voltage measurement in FMVSS No. 305 and GTR No. 13 is minor.

There is some unnecessary or redundant text in some sections of GTR No. 13 that we have not included in this proposal, to make the regulatory text more concise. An example of this is in the electrical isolation option for post-crash electrical safety, under conditions when the AC and DC high voltage sources are connected. GTR No. 13 specifies that the vehicle meet one of the following requirements: (1) Electrical isolation of the DC and AC high voltage sources from the chassis be no less than 500 ohm/volt; (2) electrical isolation of the DC and AC high voltage sources from the chassis be no less than 100 ohm/volt and the AC high voltage sources also have physical barrier protection; or (3) electrical isolation of the AC and DC high voltage sources from the chassis be no less than 100 ohm/volt and the AC high voltage source is considered as a low voltage source. We believe that the option (3) requirement above is unnecessary, because if the AC high voltage source is considered as a low voltage source, it already meets the low voltage electrical isolation option. Thus, we determined it is not necessary to provide option (3).

NHTSA initiated a research program in 2010, using Battelle as a contractor, to better understand the safety implications of using a physical barrier to protect against electric shock. The objectives of the research were to: (a) Determine failure modes associated with electrical protection barriers that could potentially result in electric shock to occupants in the vehicle or to rescue workers due to direct or indirect contact, (b) evaluate the practicability and feasibility of test procedures in what was then a draft version 30 of GTR No. 13 for direct and indirect contact protection.

As discussed below (and in our supporting technical document) 31 the Battelle research indicates that the physical barrier protection specified in GTR No. 13 would protect against electric shock when there is a single point failure in the electrical safety systems. However, if there were multiple failures in the electrical safety systems specified in GTR No. 13 for normal vehicle operating conditions,32 the Battelle research indicates that a person could receive an electric shock when they contact the high voltage sources in certain specific ways.

The Battelle study 33 identified various scenarios of electrical safety system failures, including direct contact of high voltage source, indirect contact of live parts of high voltage sources, loss in conductive connection between electrical protection barrier and chassis, and a combination of these failures. Direct contact of a high voltage source could occur in the event of a crash that results in mechanical failure of protection barriers or penetration of electrical insulation that would allow fingers or conductive tools to enter protection barriers and contact the high voltage sources within the barrier. Indirect contact of high voltage sources could occur in the event of a crash in which an electrical protection barrier is energized due to loss in electrical isolation of the high voltage source within the barrier.

To illustrate failure modes associated with electric protection barriers, Battelle used the schematic shown in Figure 4 below in which a high voltage source (shown on the left side of the figure) is isolated from the vehicle chassis by resistances RiH and RiL on the positive and negative side, respectively, and enclosed in an electrical protection barrier (EPB1). The high voltage source may be either DC or AC and may represent a variety of components such as a fuel cell, battery, motor, or capacitor.

Also shown in Figure 4 are electrical wirings from the positive side of the high voltage source to its negative side to complete the circuit. The schematic shows two electric protection barriers (EPB2 and EPB3) enclosing the wirings on the positive and negative side, respectively, and a body with resistance Rb contacting these two protection barriers. All three electrical protection barriers in the figure are conductively connected to the electrical chassis with resistances RCh, RChH, and RChL.

For normal vehicle operation, GTR No. 13 requires RiH and RiL resistances to provide electrical isolation of at least 500 ohms/VAC or 100 ohms/VDC. It also requires the electrical wiring to be insulated. Further, it requires the three electrical protection barriers (EPB1, EPB2, and EPB3) to have protection degree IPXXD or IPXXB and be conductively connected to the chassis such that the resistances RCh, RChH, and RChL are less than 0.1 ohms. The lowest possible value of body resistance Rb is 500 ohms.34

Battelle's analysis of the schematic in Figure 4 identified scenarios of direct contact and indirect contact of high voltage sources. Direct contact occurs when the electrical protection barriers EPB2 and/or EPB3 are breached or penetrated and the body contacts the wiring enclosed within. Indirect contact occurs when EPB2 and/or EPB3 are energized due to loss of electrical isolation of the high voltage source within the barrier and the body contacts the electrical protection barriers as shown in Figure 4. Examples of direct and indirect contact scenarios are presented below:

• Case 1—Direct contact of high voltage source without electric shock hazard. Protection barrier EPB2 is compromised and the body directly contacts the electrical wiring from the positive side, and also contacts the electrical protection barrier EPB3 enclosing the wiring on the negative side of the high voltage source (Figure 5). In this case, as long as the resistance RiL or RiH is greater than or equal to 500 ohms/VAC or 100 ohms/VDC, the current through the body (shown by dashed lines) will be within safe limits.

• Case 2—Direct contact of a high voltage source with electric shock hazard. Electrical protection barriers EPB2 and EPB3 of the wiring on the positive and negative side of the high voltage source are compromised and the body contacts the positive and negative wiring (Figure 6). For the worst Case 2 condition, a body resistance Rb equal to 500 ohms (lowest possible) is used. For a DC high voltage source of 350V, the minimum resistance value for RiL and RiH is 35,000 ohms. Since the body resistance Rb is significantly lower than the electrical isolation RiL and RiH, current through the body (shown by dashed lines) is not limited and the body would experience electric shock.

• Case 3—Indirect contact of high voltage source without electric shock hazard. The wiring on the positive side of the high voltage source loses electrical isolation to the electrical protection barrier, EPB2, and the body contacts the electrical protection barriers EPB2 and EPB3 of the positive and negative wiring (Figure 7). Similar to Case 1, as long as the isolation resistance RiL or RiH is greater than or equal to 500 ohms/VAC or 100 ohms/VDC, the current through the body (shown by dashed lines) will be within safe limits.

• Case 4—Indirect contact of high voltage source with possibility of electric shock. The electric wiring of the positive and negative sides of the high voltage source lose electrical isolation to the protective barriers EPB2 and EPB3, respectively, and the body contacts the two protective barriers EPB2 and EPB3 (Figure 8). Since RCh, RChH and RChL are all very low values (less than 0.1 ohms according to GTR No.13), this condition would result in a short circuit of the high voltage source that could activate and open a short circuit fuse that is generally equipped in electric propulsion vehicles. If a fuse activates, then no current will flow and so no electrical shock would occur. However, if the fuse does not activate, and if the electrical isolation RiL and RiH are reduced to low levels and the chassis resistance is not significantly low compared to the body resistance, then the current through the body contacting the protective barriers (shown by dashed line) may not be within safe limits and the body could experience electric shock. This scenario is further discussed in the Alliance petition for rulemaking (infra) and in the supporting technical document of this NPRM.

Battelle identified additional scenarios, including those regarding loss in electrical isolation RiL and/or RiH and loss of electrical bonding of the protective barriers with the chassis.35 These scenarios showed that, for vehicles that meet the electrical isolation and physical barrier protection requirement in GTR No. 13 during normal vehicle operation, electric shock is not possible when there is only a single point of failure in the electrical safety systems. However, electric shock is possible when at least two or three failures of electrical safety systems occur and a human body comes into contact with two compromised protective barriers on opposite sides of the high voltage source to complete the circuit. For example, in Case 2, electric shock could occur if two electrical protection barriers on the positive and negative side of the high voltage source are compromised and a body contacts the positive and negative side of a high voltage source by entering the two compromised protection barriers. In Case 4, electric shock could occur only if at least four electric safety features (loss in electrical isolation of electrical protection barriers EPB2 and EPB3 which are on the positive and negative side of the high voltage source and loss in electrical isolation RiH and RiL of the high voltage source) are compromised and the body contacts both compromised barriers, EPB2 and EPB3.

To address the concern of electric shock from indirect contact, GTR No. 13 specifies that the physical barriers enclosing high voltage sources should be conductively connected with low resistance (less than 0.1 ohms) to the electrical chassis, so that if one segment of the high voltage source should lose electrical isolation, all contactable surfaces of the vehicle chassis and protective barriers will be at the same voltage and thereby prevent electric shock to a person touching two different protective barriers or parts of the electrical chassis.

Battelle also evaluated the maximum resistance (0.1 ohms) of the electric bonds between electrical protection barriers and the electrical chassis that is specified in GTR No. 13. Battelle found that in the event of multiple electrical safety system failures (loss in electrical isolation of both segments of the high voltage source to their electrical protection barriers) and a person touching both the barriers to complete the circuit, the resistance of 0.1 ohms between the protective barrier and electrical chassis would not be sufficient to prevent electric shock to the person contacting the protective barriers.36

On December 23, 2013, Toyota submitted a petition for rulemaking to amend FMVSS No. 305 by adding an additional compliance option for electrical safety to allow HFCVs to be offered for sale in the US. Toyota notes that the requested compliance option includes elements of the electrical protection barrier that is currently in GTR No. 13. Toyota notes that many countries, including the European Union, Japan, and South Korea, already include electrical protection barrier as a compliance option for electrical safety in their standards.

Toyota explains its reasons for petitioning as follows.37 FMVSS No. 305 requires compliance with electrical safety requirements following impacts “at any speed up to and including” the specified test speeds. Toyota notes that for electric powered vehicles, including fuel cell vehicles, the DC high voltage sources (e.g. high voltage battery) will be connected to the AC high voltage sources (e.g. electric motor) during normal vehicle operation and in low speed crashes where the automatic disconnect does not operate.38 In such conditions, when the AC and DC high voltage sources are connected, the isolation resistance at the AC high voltage source is in parallel with the isolation resistance of the DC high voltage source. Therefore, even if the electrical isolation provided for the AC high voltage source is significantly greater than the required 500 ohms/volt, the effective isolation resistance measured at the AC high voltage source can be, at most, as high as that provided for the DC high voltage source.

Toyota explains that in current battery electric vehicles, manufacturers are able to provide electrical isolation for the high voltage battery in excess of 500 ohms/volt, even though FMVSS No. 305 permits DC high voltage sources to have 100 ohms/volt with an electrical isolation monitoring system. On the other hand, it is difficult to maintain electrical isolation greater than 500 ohms/volt for the fuel cell stack in an HFCV due to the presence of fuel cell coolant.39 Therefore, when the DC and AC high voltage sources are connected in an HFCV, it may not be possible to achieve the required 500 ohms/volt electrical isolation for AC high voltage sources.

Toyota states that NHTSA said in the June 14, 2010 final rule (75 FR 33515) that the agency was issuing the final rule to facilitate the development and introduction of fuel cell vehicles. One provision provided by the final rule was to specify lower minimum electrical isolation requirements for DC than AC high voltage sources (500 ohms/volt for AC and 100 ohms/volt for DC sources). Toyota further asserts that this flexibility offered for HFCVs is not useful unless a provision is made for the condition when the AC and DC high voltage sources are connected, such as after a low speed crash.40 Since such a provision is currently not available, HFCVs are essentially required to provide electrical isolation levels at or in excess of 500 ohms/volt at the fuel cell stacks.

Toyota asks that NHTSA adopt an alternative provision for electrical safety through isolation of high voltage sources that involves electrical protection barriers to address post-crash conditions where the AC and DC high voltage sources are connected. The petitioner suggests adopting GTR No. 13's specification that the electrical isolation of the high voltage source may be greater or equal to 100 ohms/volt for an AC high voltage source if that AC source is conductively connected to a DC high voltage source, provided that the AC high voltage source meets the specified post-crash physical barrier protection requirements in GTR No. 13.41 The petitioner suggests specific regulatory text for the requirements and test procedures that are based on the specifications in GTR No. 13 for modifying FMVSS No. 305 to include the petitioner's requested compliance option.

Toyota also requests that NHTSA amend S6.4 of FMVSS No 305 which requires vehicles to satisfy all of the post-crash performance requirements “after being rotated on its longitudinal axis to each successive increment of 90 degrees . . . . .” to indicate that compliance with electrical isolation and physical barrier protection requirements would be evaluated after the vehicle is rotated a full 360 degrees. Toyota notes that the vehicle conditions related to the electrical isolation and physical barrier protection requirements do not change at various increments of a rollover and that it would be unreasonably dangerous for laboratory personnel to conduct the specified tests with the vehicle at 90 degree increments.

On November 10, 2014, the Alliance submitted a petition for rulemaking to update and upgrade FMVSS No. 305 to incorporate a physical barrier compliance option to provide protection against electric shock. The Alliance states that the implementation of a physical barrier compliance option is especially critical to facilitate both the introduction of complying HFCVs as well as 48 volt mild hybrid technologies.42 The petitioner also believes the amendments would enable safe design innovation for all electrified vehicles, as well as reduce CO2 emissions and increase fuel economy.

The Alliance states that the physical barrier compliance option is essential for FMVSS No. 305 certification of HFCVs in low speed crashes where the automatic disconnect is not designed to operate. The Alliance also states that in such crashes, the DC high voltage source can impinge on the AC high voltage sources through the inverter, making it impractical to achieve 500 ohms/volt electrical isolation for the AC high voltage source.

The Alliance explains that while it would seem that 48 volt mild hybrid systems would not be within the intended scope of FMVSS No. 305,43 these systems typically convert DC voltage into three-phase AC voltage that can exceed the 30 VAC voltage threshold for consideration as a high voltage source in FMVSS No. 305.44 The Alliance states that these 48 volt mild hybrid systems are grounded to the vehicle chassis and so cannot viably meet the existing isolation resistance option as well as the pretest measurement for isolation resistance. The Alliance notes that while it is feasible to design a 48 volt mild hybrid system that meets FMVSS No. 305 electrical isolation requirements, isolated systems inherently involve more complexity, higher consumer costs, and higher mass resulting in reduced fuel economy and increased emissions. The Alliance suggests that these results are particularly inappropriate since there is no incremental safety benefit provided by an isolated system compared to physical barriers. The Alliance states that as a result, it is requesting modifications to FMVSS No. 305 to permit the introduction 48 volt mild hybrid systems and HFCVs into the U.S.

The Alliance notes that in NHTSA's July 29, 2011, response to petitions for reconsideration of the 2010 final rule,45 NHTSA deferred consideration of the physical barrier protection option pending additional research. The Alliance states that the agency's research on the physical barrier option 46 showed that electric shock from indirect contact in a crash could only be possible, if the following conditions were met (see Case 4 described above and illustrated in Figure 8):

(1) A loss of electrical isolation within the enclosure of a high voltage source,

(2) a loss of electrical isolation within a second (different) high voltage source enclosure,

(3) these two distinct losses in isolation (specified in (1) and (2)) occur on opposite rails (positive and negative) of the high voltage source,

(4) the overcurrent devices do not automatically open the circuit as a result of the simultaneous loss of isolation on the positive and negative rails to ground (the Alliance states that the normal design practice is for the overcurrent devices to automatically open under the circumstances outlined in (3)),

(5) a person has access to these two enclosures in the crashed vehicle, and

(6) a person touches these two enclosures simultaneously.

The Alliance believes that the likelihood of each of the above 6 events occurring is remote and that the simultaneous occurrence of these events in real world situations is even more remote and exceedingly small. The Alliance believes that the other scenarios identified in the Battelle final report as having potential safety concerns similarly require multiple failures in the system to occur, followed by what the petitioner believes to be unlikely human contacts and a lack of fuses or other electrical safety protection. Nevertheless, the Alliance states that, despite the extremely low likelihood of a safety issue from any of the scenarios in the final Battelle report, the updated version of SAE J1766 (January 2014) 47 includes performance requirements that safeguard against all safety critical scenarios identified in the Battelle report.

The Alliance expresses its support of the December 23, 2013 petition for rulemaking from Toyota to modify FMVSS No. 305 to facilitate the sale of HFCVs in the U.S. (petition discussed infra) and notes that the January 2014 version of SAE J1766 also includes provisions for a modified isolation requirement for AC systems with physical barriers, as Toyota requests in its petition for rulemaking. The Alliance states that SAE J1766 January 2014 also has provisions for a “stand-alone” physical barrier protection compliance option that is needed for facilitating the development of 48 volt mild hybrid systems, since electrical components of these systems are conductively connected to the chassis and so cannot viably satisfy electrical isolation requirements. The Alliance believes that this “stand-alone” physical barrier compliance option provides sufficient protection to address potential (although unlikely, states the petitioner) safety critical scenarios identified in the Battelle report.

The Alliance asserts that while FMVSS No. 305 only evaluates electrical safety in post-crash condition, auto manufacturers also design for high voltage safety under normal operating conditions. The petitioner states that providing physical barriers is the most common method of protection against high voltage contact in the automotive industry, as well as other industries that use high voltage electric circuits. The Alliance believes it is reasonable that this method of protection against electric shock hazard can also be used for post-crash shock protection provided these physical barriers remain intact post-crash, and that either the voltage between exposed conductive parts is below 30 VAC or 60 VDC, or resistance between exposed conductive parts of the barriers and electrical chassis is below specified resistance levels.

The Alliance states it is urgent to update FMVSS No. 305 to facilitate the introduction of HFCVs and 48 volt mild hybrid technology vehicles that are necessary to accommodate compliance with Corporate Average Fuel Economy (CAFE) standards. Consequentially, the petitioner states that it is not additionally requesting adoption of the low energy compliance option that is also included in SAE J1766 January 2014. Instead the petitioner requests that the low energy compliance option be considered for the electric vehicle safety (EVS) GTR that is currently in process.

SAE J1766 January 2014 also changes the time criterion for initiating verification of post-crash electrical safety from 5 seconds after the vehicle comes to rest (similar to the specification currently in FMVSS No. 305) to 10 seconds after initial impact. The Alliance states that given the urgency necessary to facilitate the introduction of HFCVs and 48 volt mild hybrid technology, it is limiting its petition for rulemaking to only include the post-crash physical barrier protection compliance option in SAE J1766 January 2014 into FMVSS No. 305.

Specifically, the Alliance requests including section 5.3.4 of SAE J1766 January 2014 into FMVSS No. 305. This section provides two options for post-crash electrical safety by means of physical barriers.

The first option (Option 1 for physical barrier protection) is similar to the post-crash physical barrier protection option for electrical safety in GTR No. 13,48 but includes an additional requirement that the resistance between the high voltage source enclosed by the physical barrier and the exposed conductive parts of the electrical protection barrier be greater than 0.01 ohms/volt for DC high voltage sources and 0.05 ohms/volt for AC high voltage sources.

The second option for electrical safety through electrical protection barriers (Option 2 for physical barrier protection) in SAE J1776 January 2014 is through protection from direct contact by protection degree IPXXB, and that the voltage between the electrical protection barrier and other exposed conductive parts and the electrical chassis is less than or equal to 30 VAC for AC high voltage sources and 60 VDC for DC high voltage sources. The Alliance states that Option 2 is similar to the low voltage option already in FMVSS No. 305.

The Alliance supplemented its petition by a submission dated October 20, 2015, which provided an analysis of its proposal for electrical safety through physical barriers.49 Figure 9, below, presents the circuit diagram the petitioner provided for the representation of a high voltage source (e.g., battery) with voltage of 1,000 VAC or 1,500 VDC, enclosed in physical barriers that are conductively connected to the electrical chassis with resistance less than or equal to 0.1 ohms. The circuit diagram also has a representation of a human body with a minimum resistance of 500 ohms 50 contacting protective barriers enclosing opposite rails of the high voltage source. The resistances R1 and R2 in Figure 9 represent the resistance between the high voltage source and the protective physical barriers that enclose it. This circuit diagram is a representation of the indirect contact Battelle scenario, Case 4, in the event that electrical isolation of the high voltage source to the chassis is lost and RiH and RiL are equal to zero.

According to Option 1 of the electrical protection barrier in the Alliance submission, the combined resistance 51 of R1 and R2 is required to be less than or equal to 0.05 ohms/VAC or 0.01 ohms/VDC. Under Option 2, the voltage difference between barrier #1 and barrier #2 is required to be less than or equal to 30 VAC or 60 VDC. The Alliance observes that its analysis using the model in Figure 9 demonstrates that the proposed physical barrier protection option provides equivalent levels of safety as the electrical isolation option 52 currently in FMVSS No. 305 in all the safety critical scenarios identified in the Battelle study, including the scenario Case 4 for indirect contact.

The Alliance also states that the Option 1 electrical protection barrier is the same as that of Option 2 since the conditions that meet the Option 1 requirements also meet the Option 2 requirements. The Alliance acknowledges that it is difficult to measure the resistance between a high voltage source and the exposed conductive parts of the electrical protection barrier that encloses the high voltage source, as is needed to evaluate the Option 1 electrical protection barrier.53 The Alliance recommends that NHTSA incorporate Option 2 (direct contact protection degree IPXXB and voltage between electrical protection barrier and exposed conductive parts less than or equal to 30 VAC or 60 VDC) into FMVSS No. 305 since its analysis indicates that compliance with Option 1 would also entail compliance with Option 2.

The Alliance specifies the following test procedures from Appendix C in SAE J1766 January 2014: (1) Section C.1 for verifying IPXXB protection degree of physical barriers, which is similar to the procedure in GTR No. 13, (2) Section C.2.1 for verifying that the resistance between electrical protection barriers and electrical chassis is less than 0.1 ohms, and (3) Section C.2.3 to verify that the voltage difference between any two exposed conductive parts of the electric chassis (including physical barriers) is less than or equal to 30 VAC or 60 VDC. The Alliance also specifies Section C.2.2 in SAE J1766 January 2014 for verifying that the resistance between a high voltage source and the electrical chassis 54 is greater than or equal to 0.05 ohms/VAC or 0.01 ohms/VDC. We note, however, that section C.2.2 does not provide a specific method of measurement and instead states, “The measurement may be performed by any means that provides sufficient accuracy for the post-crash situation.”

These test procedures are further discussed in a later section analyzing the petitions for rulemaking to modify FMVSS No. 305.

NHTSA is initiating rulemaking to consider adopting GTR No. 13 into FMVSS No. 305, as appropriate under the Vehicle Safety Act, and to address the issues raised by the Alliance and Toyota in their respective petitions. We request comment on the decisions put forth in this NPRM, including those regarding minor additional provisions that the agency is considering to address the concerns of the petitioners.

NHTSA believes that this NPRM would improve the level of safety afforded to the public. Adopting the provisions from GTR No. 13 that reduce the risk of harmful electric shock during normal vehicle operation would improve FMVSS No. 305 by expanding its performance requirements beyond post-crash conditions. The proposed requirements would provide post-crash compliance options for new power train configurations that ensure that those configurations provide a comparable level of post-crash safety compared to existing electric vehicles.

The proposed amendments are summarized as follows. In furtherance of implementing GTR No. 13 and in response to the petitions for rulemaking—

a. This NPRM proposes to add electrical safety requirements for vehicle performance during normal vehicle operations (as opposed to during and after a crash), to mitigate electric shock due to loss in electrical isolation and direct or indirect contact of high voltage sources. The electrical safety requirements during normal vehicle operations would include requirements for:

b. This NPRM proposes to amend FMVSS No. 305's post-crash electrical safety requirements. The post-crash electrical safety requirements would include:

We first discuss the proposed requirements for vehicle performance during normal vehicle operations, followed by those for performance post-crash.

GTR No. 13 specifies safety measures to ensure that high voltage sources cannot be contacted. This safety measure is to enclose high voltage sources in physical barriers (electrical protection barriers) to prevent direct human contact. NHTSA is proposing to include in FMVSS No. 305 the direct contact protection requirements specified in GTR No. 13 for the passenger and luggage compartments and other areas.55

NHTSA is proposing to assess protection against direct contact with high voltage sources contained inside the passenger and luggage compartments using a 1.0 mm diameter and 100 mm long test wire probe (IPXXD). This test probe ensures that any gaps in the protective barriers are no larger than 1 mm and that any live components contained within are no closer to the gap than 100 mm. This ensures that body parts, miscellaneous tools or other slender conductive items typically present in a passenger or luggage compartment cannot penetrate any gaps/seams in the protective enclosures and contact high voltage components contained within.

For assessing protection against direct contact with high voltage sources in areas other than the passenger and luggage compartments under normal operating conditions, NHTSA is proposing to use the test probe IPXXB, representing a test finger. In areas other than the passenger and luggage compartments, the barrier would not likely contact tools and other slender conductive items. Therefore, protection using the test wire probe IPXXD would not be necessary and the test finger probe IPXXB would be appropriate to prevent inadvertent contact with high voltage components contained in the protective enclosures, by persons such as mechanics.

GTR No 13 also requires that a service disconnect that can be opened, disassembled, or removed without tools requires IPXXB protection when it is opened, disassembled, or removed. NHTSA is proposing to include this requirement into FMVSS No. 305, as well as a definition for a service disconnect.

NHTSA is proposing marking (yellow high voltage symbol) for enclosures and barriers of high voltage sources that can be physically accessed, opened, or removed without the use of tools, similar to GTR No. 13. As explained earlier in this preamble, we are not excluding some barriers as GTR No. 13 does.

NHTSA is proposing that cables for high voltage sources which are not located within electrical protection barriers to be identified by an orange color outer covering, similar to GTR No. 13. However, as explained earlier in this preamble, we are not excluding some connectors as GTR No. 13 does.

As noted earlier in this preamble, GTR No. 13 specifies direct contact protection requirements for high voltage connectors separately, and has exclusions with which we do not agree. Per GTR No. 13, connectors do not need to meet IPXXB protection if they are located underneath the vehicle floor and are provided with a locking mechanism, or require the use of tools to separate the connector, or the voltage reduces to below 30 VAC or 60 VDC within one second after the connector is separated. For the reasons given earlier, NHTSA does not believe that the exclusions are warranted and does not anticipate adopting them in a final rule.

Under GTR No. 13, exposed conductive parts (parts that can be contacted with the test probes, IPXXD or IPXXB, and become electrically energized under electrical isolation failure conditions) have to be protected against indirect contact during normal vehicle operation. GTR No. 13 requires electrical protection barriers or enclosures of high voltage sources to be conductively connected to the electrical chassis with resistance of no more than 0.1 ohms during normal vehicle operations. This requirement would provide protection from electric shock by shunting 56 any harmful electrical currents to the vehicle chassis should any electrically charged components lose isolation within the protective barrier.

For indirect contact protection, we propose to apply the same indirect contact protection requirements and test procedures as would apply under post-crash conditions (see discussion in next section, below). The proposed indirect contact protection requirements would be for exposed conductive parts of electrical protection barriers to be conductively connected to the chassis with a resistance less than 0.1 ohms and that the resistance between two simultaneously reachable exposed conductive parts of electrical protection barriers that are within 2.5 meters of each other be less than 0.2 ohms. These resistances would be measured by passing a current of at least 0.2 A between exposed conductive parts and the electrical chassis. For the reasons previously discussed, NHTSA is not including GTR No. 13's provision that permits visual inspection of welds as a method of assessing compliance of indirect contact protection.

This NPRM would require that under normal operating conditions, all high voltage sources of the power train and those connected to the power train have sufficient electrical isolation resistance measured against the electrical chassis to ensure that current flowing through a human body in contact with the vehicle is not dangerous.

For conditions where DC and AC high voltage sources are isolated from each other, DC high voltage sources would be required to have a minimum electrical isolation of 100 ohms/volt and AC high voltage sources would be required to have a minimum of 500 ohms/volt.

For conditions where DC and AC high voltage sources are connected, AC and DC high voltage sources would be permitted to have a minimum electrical isolation of 100 ohms/volt, provided the AC high voltage source has direct and indirect contact protection in a. and b. above.

We proposed to exclude 48 volt hybrid vehicles from these electrical isolation requirements during normal vehicle operation. Since electric components in 48 volt mild hybrid systems are conductively connected to the electric chassis, these systems would not be able to comply with electrical isolation requirements both during normal vehicle operations and after a crash. Therefore, we believe that the “normal use” requirements in GTR No. 13 need to be modified to permit the introduction of 48 volt mild hybrid systems.

The United Nations Economic Commission for Europe Regulation 100 (ECE R.100) 57 normal operation requirements were modified on June 10, 2014 to facilitate the development and sale of 48 volt mild hybrid systems. Under these changes, 48 volt mild hybrid systems that are conductively connected to the electrical chassis are exempt from the in-use electrical isolation requirements. However, electrical protection barriers are still required during normal vehicle operations for high voltage components of these 48 volt mild hybrid systems so as to provide direct and indirect contact protection. As discussed in a later section for post-crash electrical safety requirements, we believe that these 48 volt mild hybrid systems with electrical protection barriers for all high voltage components in the system would not pose concerns regarding electric shock. Therefore, NHTSA proposes to include a similar exclusion from in-use electrical isolation requirements for 48 volt mild hybrid systems that are conductively connected to the electrical chassis.

This proposed rule is accessible via the Internet at the Office of the Federal Register Web site at https://www.federalregister.gov. Background information and documents are available at the NMFS West Coast Region Web site at http://www.westcoast.fisheries.noaa.gov/fisheries/management/whiting/pacific_whiting.html and at the Pacific Fishery Management Council's Web site at http://www.pcouncil.org/.

The regulations at 50 CFR 660.50(d) establish the process by which the tribes with treaty fishing rights in the area covered by the Pacific Coast Groundfish Fishery Management Plan (FMP) request new allocations or regulations specific to the tribes, in writing, during the biennial harvest specifications and management measures process. The regulations state that the Secretary will develop tribal allocations and regulations in consultation with the affected tribe(s) and, insofar as possible, with tribal consensus. The procedures NMFS employs in implementing tribal treaty rights under the FMP were designed to provide a framework process by which NMFS can accommodate tribal treaty rights by setting aside appropriate amounts of fish in conjunction with the Pacific Fishery Management Council (Council) process for determining harvest specifications and management measures.

Since the FMP has been in place, NMFS has been allocating a portion of the U.S. total allowable catch (TAC) (called Optimum Yield (OY) or Annual Catch Limit (ACL) prior to 2012) of Pacific whiting to the tribal fishery, following the process established in 50 CFR 660.50(d). The tribal allocation is subtracted from the U.S. Pacific whiting TAC before allocation to the non-tribal sectors.

There are four tribes that can participate in the tribal whiting fishery: the Hoh Tribe, the Makah Tribe, the Quileute Tribe, and the Quinault Indian Nation (collectively, the “Treaty Tribes”). The Hoh Tribe has not expressed an interest in participating to date. The Quileute Tribe and Quinault Indian Nation have expressed interest in participating in the whiting fishery. However, to date, only the Makah Tribe has prosecuted a tribal fishery for Pacific whiting. They have harvested whiting since 1996 using midwater trawl gear. Tribal allocations have been based on discussions with the Treaty Tribes regarding their intent for those fishing years. Table 1 below provides a history of U.S. OYs and annual tribal allocation in metric tons (mt).

In 2009, NMFS, the states of Washington and Oregon, and the Treaty Tribes started a process to determine the long-term tribal allocation for Pacific whiting; however, no long-term allocation has been determined. In order to ensure Treaty Tribes continue to receive allocations, this rule proposes the 2016 tribal allocation of Pacific whiting. This is an interim allocation not intended to set precedent for future allocations.

In exchanges between NMFS and the Treaty Tribes during 2015, the Makah Tribe indicated their intent to participate in the tribal whiting fishery in 2016. The Makah Tribe has requested 17.5% of the U.S. TAC. The Quileute Tribe and the Quinault Indian Nation indicated that they are not planning to participate in 2016. NMFS proposes a tribal allocation that accommodates the Makah request, specifically 17.5% of the U.S. TAC. NMFS believes that the current scientific information regarding the distribution and abundance of the coastal Pacific whiting stock suggests that 17.5% is within the range of the tribal treaty right to Pacific whiting.

The Joint Management Committee, which was established pursuant to the Agreement between the United States and Canada on Pacific Hake/Whiting (the Agreement), is anticipated to recommend the coastwide and corresponding U.S./Canada TACs no later than March 25, 2016. The U.S. TAC is 73.88% of the coastwide TAC. Until this TAC is set, NMFS cannot propose a specific amount for the tribal allocation. The whiting fishery typically begins in May, and the final rule establishing the whiting specifications for 2016 is anticipated to be published by early May. Therefore, in order to provide for public input on the tribal allocation, NMFS is issuing this proposed rule without the final 2016 TAC. However, to provide a basis for public input, NMFS is describing a range of potential tribal allocations in this proposed rule, applying the proposed approach to determining the tribal allocation to a range of potential TACs derived from historical experience.

In order to project a range of potential tribal allocations for 2016, NMFS is applying its proposed approach to determining the tribal allocation to the range of U.S. TACs over the last 10 years, 2006 through 2015 (plus or minus 25% to capture variability in stock abundance). The range of TACs in that time period was 135,939 mt (2009) to 325,072 mt (2015). Applying the 25% variability results in a range of potential TACs of 101,954 mt to 406,340 mt for 2016. Therefore, using the proposed allocation rate of 17.5%, the potential range of the tribal allocation for 2016 would between 17,842 and 71,110 mt.

This proposed rule would be implemented under authority of Section 305(d) of the Magnuson-Stevens Act, which gives the Secretary responsibility to “carry out any fishery management plan or amendment approved or prepared by him, in accordance with the provisions of this Act.” With this proposed rule, NMFS, acting on behalf of the Secretary, would ensure that the FMP is implemented in a manner consistent with treaty rights of four Northwest Tribes to fish in their “usual and accustomed grounds and stations” in common with non-tribal citizens. United States v. Washington, 384 F. Supp. 313 (W.D. 1974).

NMFS has preliminarily determined that the management measures for the 2016 Pacific whiting tribal fishery are consistent with the national standards of the Magnuson-Stevens Act and other applicable laws. In making the final determination, NMFS will take into account the data, views, and comments received during the comment period.

The Office of Management and Budget has determined that this proposed rule is not significant for purposes of Executive Order 12866.

As required by section 603 of the Regulatory Flexibility Act (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was prepared. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A summary of the analysis follows. A copy of this analysis is available from NMFS.

Under the RFA, the term “small entities” includes small businesses, small organizations, and small governmental jurisdictions. The Small Business Administration (SBA) has established size criteria for entities involved in the fishing industry. A business involved in fish harvesting is a small business if it is independently owned and operated and not dominant in its field of operation (including its affiliates) and if it has combined annual receipts, not in excess of $20.5 million for all its affiliated operations worldwide (See 79 FR 33647; June 12, 2014). For marinas and charter/party boats, a small business now defined as one with annual receipts, not in excess of $7.5 million. For purposes of rulemaking, NMFS is applying the $20.5 million standard to catcher processors (C/Ps) because Pacific whiting C/Ps are involved in the commercial harvest of finfish. A wholesale business servicing the fishing industry is a small business if it employs 100 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. Effective February 26, 2016, a seafood processor is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 750 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide (See NAICS 311710 at 81 FR 4469; January 26, 2016).

Small organizations. The RFA defines small organizations as any nonprofit enterprise that is independently owned and operated and is not dominant in its field.

Small governmental jurisdictions. The RFA defines small governmental jurisdictions as governments of cities, counties, towns, townships, villages, school districts, or special districts with populations of less than 50,000.

This proposed rule would allocate 17.5% of the U.S. Total Allowable Catch of Pacific whiting for 2016 to Pacific Coast Indian tribes that have a Treaty right to harvest groundfish. This allocation percentage was used for the 2015 fishery. The entities that this rule directly impacts are the Makah Tribe and the following in the non-tribal fisheries: Quota share (QS) holders in the Shorebased Individual Fishing Quota (IFQ) Program—Trawl Fishery; vessels in the Mothership Coop (MS) Program—Whiting At-sea Trawl Fishery; and the C/P Coop Whiting At-sea Trawl Fishery. These entities determine how much of their allocations are to be actually fished and what vessels are allowed to fish their allocations. This rule proposes to allocate fish to the Makah Tribe. Based on groundfish ex-vessel revenues and on tribal enrollments (the population size of each tribe), the Makah Tribe is considered a small entity.

Currently, the Shorebased IFQ Program is composed of 172 Quota Share permits/accounts, 152 vessel accounts, and 44 first receivers. The MS fishery is currently composed of a single coop, with six mothership processor permits, and 34 Mothership/Catcher-Vessel (MS/CV) endorsed permits, with three permits each having two catch history assignments. The C/P Program is composed of 10 C/P permits owned by three companies that have formed a single co-op. Many companies participate in two sectors and some participate in all three sectors. All of the 34 mothership catch history assignments are associated with a single mothership co-op and all ten of the catcher-processor permits are associated with a co-op. These co-ops are considered large entities from several perspectives; they have participants that are large entities, whiting co-op revenues exceed or have exceeded the $20.5 million, or co-op members are connected to American Fishing Act permits or co-ops where the NMFS Alaska Region has determined they are all large entities (79 FR 54597; September 12, 2014). After accounting for cross participation, multiple QS account holders, and affiliation through ownership, NMFS estimates that there are 103 non-tribal entities directly affected by these proposed regulations, 89 of which are considered “small” businesses.

For the years 2011 to 2015, the total whiting fishery (tribal and non-tribal) averaged harvests of approximately 205,000 mt annually, worth over $52 million in ex-vessel revenues. As the U.S. whiting TAC has been highly variable during this time, so have harvests. In the past five years, harvests have ranged from 160,000 mt (2012) to 264,000 mt (2014). Ex-vessel revenues have also varied in the same period, with annual ex-vessel revenues ranging from $25 million (2015) to $65 million (2013 and 2014). Total whiting harvest in 2015 was approximately 151,000 mt worth $25 million, at an ex-vessel price of $167 per mt. In 2014, harvest was 264,000 tons, and ex-vessel revenues were over $64 million with an average ex-vessel price of $240 per mt. The prices for whiting are largely determined by the world market for groundfish, because most of the whiting harvested is exported. Poor world market conditions led to a decrease in prices in 2015. There was no tribal catch of Pacific whiting in 2015, and overall, a lower percentage of the commercial TAC was harvested than in prior years.

The use of ex-vessel values does not take into account the wholesale or export value of the fishery, or the costs of harvesting and processing whiting into a finished product. The latest available economic data indicates that in 2012, motherships received $30.3 million in wholesale revenue, C/Ps received $51 million, and shoreside processors $55 million. The Pacific whiting fishery harvests almost exclusively Pacific whiting. While bycatch of other species occurs, the fishery is constrained by bycatch limits on key overfished species. This is a high-volume fishery with low ex-vessel prices per pound. This fishery also has seasonal aspects based on the distribution of whiting off the west coast.

Since 1996, there has been a tribal allocation of the U.S. Pacific whiting TAC. Tribal fisheries undertake a mixture of fishing activities that are similar to the activities that non-tribal fisheries undertake. Tribal harvests have been delivered to both shoreside plants and at-sea processors. These processing facilities also process fish harvested by non-tribal fisheries.

This proposed rule would allocate 17.5% of Pacific whiting to the tribal fishery, and would ultimately determine how much is left for allocation to the non-tribal sectors. The amount of whiting allocated to both the tribal and non-tribal sectors is based on the U.S. TAC. From the U.S. TAC, small amounts of whiting that account for research catch and for bycatch in other fisheries are deducted. The amount of the tribal allocation is also deducted directly from the TAC. After accounting for these deductions, the remainder is the commercial harvest guideline. This guideline is then allocated among the three non-tribal sectors as follows: 34 percent for the C/P Coop Program; 24 percent for the MS Coop Program; and 42 percent for the Shorebased IFQ Program.

The effect of the tribal allocation on non-tribal fisheries will depend on the level of tribal harvests relative to their allocation and the reapportioning process. Total whiting harvest in 2015 was approximately 151,000 mt worth $25 million, at an ex-vessel price of $167 per mt. Assuming a similar TAC and ex-vessel price in 2016, if the Treaty Tribes were to harvest 17.5%, the approximate value of that harvest would be $4.4 million. If the Treaty Tribes do not harvest their entire allocation, there are opportunities during the year to reapportion unharvested tribal amounts to the non-tribal fleets. For example, in 2015, NMFS executed one such reapportionment. The best available information through September 14, 2015, indicated that at least 30,000 mt of the tribal allocation would not be harvested by December 31, 2015. To allow for full utilization the resource, NMFS reapportioned 30,000 mt on September 16, 2015, to the Shorebased IFQ Program, C/P Coop and MS Coop in proportion to each sector's original allocation. Reapportioning this amount was expected to allow for greater attainment of the TAC while not limiting tribal harvest opportunities for the remainder of the year. The revised Pacific whiting allocations for 2015 following the reapportionment were: Tribal 26,888 mt; C/P Coop 100,873 mt; MS Coop 71,204 mt; and Shorebased IFQ Program 214,607 mt.

NMFS considered two alternatives for this action: the “No-Action” and the “Proposed Action.” NMFS did not consider a broader range of alternatives to the proposed allocation. The tribal allocation is based primarily on the requests of the tribes. These requests reflect the level of participation in the fishery that will allow them to exercise their treaty right to fish for whiting. Under the Proposed Action alternative, NMFS proposes to set the tribal allocation percentage at 17.5%, as requested by the tribes. This would yield a tribal allocation of between 17,842 and 71,110 mt for 2016. Consideration of a percentage lower than the tribal request of 17.5% is not appropriate in this instance. As a matter of policy, NMFS has historically supported the harvest levels requested by the tribes. Based on the information available to NMFS, the tribal request is within their tribal treaty rights. A higher percentage would arguably also be within the scope of the treaty right. However, a higher percentage would unnecessarily limit the non-tribal fishery.

Under the No-Action alternative, NMFS would not make an allocation to the tribal sector. This alternative was considered, but the regulatory framework provides for a tribal allocation on an annual basis only. Therefore, the no-action alternative would result in no allocation of Pacific whiting to the tribal sector in 2016, which would be inconsistent with NMFS' responsibility to manage the fishery consistent with the tribes' treaty rights. Given that there is a tribal request for allocation in 2016, this alternative received no further consideration.

NMFS believes this proposed rule would not adversely affect small entities. The reapportioning process allows unharvested tribal allocations of whiting, fished by small entities, to be fished by the non-tribal fleets, benefitting both large and small entities. Nonetheless, NMFS has prepared an IRFA and is requesting comments on this conclusion. See ADDRESSES.

There are no reporting, recordkeeping or other compliance requirements in the proposed rule.

No Federal rules have been identified that duplicate, overlap, or conflict with this action.

Pursuant to Executive Order 13175, this proposed rule was developed after meaningful consultation and collaboration with tribal officials from the area covered by the FMP. Consistent with the Magnuson-Stevens Act at 16 U.S.C. 1852(b)(5), one of the voting members of the Pacific Council is a representative of an Indian tribe with federally recognized fishing rights from the area of the Council's jurisdiction. In addition, NMFS has coordinated specifically with the tribes interested in the whiting fishery regarding the issues addressed by this rule.

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