Federal Register Vol. 82, No.186,

In FR Doc. 2017-19997 appearing on page 44036 in the Federal Register on Wednesday, September 20, 2017, the following corrections are made:

In FR Doc. 2017-19996 appearing on page 44044 in the Federal Register on Wednesday, September 20, 2017, the following corrections are made:

Please refer to Docket ID NRC-2017-0138 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0138.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2017-0138 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

This rule is limited to the changes associated with renewal of the initial certificate and Amendment Nos. 1 through 11, 13, Revision 1, and Amendment No. 14 to CoC No. 1004 and does not include other aspects of the NUHOMS® System design. The NRC is using the “direct final rule procedure” to issue these renewals because they represent a limited and routine change to an existing CoC that is expected to be noncontroversial. Adequate protection of public health and safety continues to be ensured. This direct final rule will become effective on December 11, 2017. However, if the NRC receives significant adverse comments on this direct final rule by October 27, 2017, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or technical specifications (TSs).

For detailed instructions on filing comments, please see the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register.

Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled, “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). A general license authorizes a reactor licensee to store spent fuel in NRC-approved casks at a site that is licensed to operate a power reactor under 10 CFR parts 50 or 52. This rule also established a new subpart L in 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on December 22, 1994 (59 FR 65898) that approved the NUHOMS® System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1004. Most recently, on January 25, 2017 (82 FR 8353), the NRC approved Revision 1 to the initial certificate and Amendment Nos. 1 through 11 and 13, and issued Amendment No. 14.

On November 4, 2014, AREVA submitted a renewal application for the Standardized NUHOMS® Horizontal Modular Storage System, CoC No. 1004, for a period of 40 years beyond the initial certificate term. AREVA supplemented its request on October 16, 2015; June 6, 2016; and September 29, 2016.

On November 18, 2016, TN Americas LLC provided notification that it had changed from AREVA TN Americas, a former operating division of AREVA Inc., to a stand-alone entity named TN Americas LLC, which is a wholly owned subsidiary company of AREVA Nuclear Materials LLC. Because the renewed CoCs will be issued to TN Americas LLC, this notice will specify “TN Americas” when referring to the CoC holder, and “AREVA” when referring to the applicant.

The renewal of the initial certificate and Amendment Nos. 1 through 11, 13, and 14 (Amendment No. 12 was never issued) were conducted in accordance with the renewal provisions in 10 CFR 72.240. This section of NRC spent fuel storage regulations authorizes the NRC staff to include any additional certificate conditions it deems necessary to ensure that the cask system's SSCs continue to perform their intended safety functions during the certificates' renewal period. The NRC staff has included additional conditions in the renewed certificates. These conditions do not revise the authorized contents of any existing or planned NUHOMS® System. The changes require, among other things, that all future amendments and revisions to this CoC include evaluations of the impacts to aging management activities (i.e., time-limited aging analyses and AMPs) to ensure that they remain adequate for any changes to spent fuel storage cask SSCs within the scope of the renewal. Each general licensee using a NUHOMS® System at a reactor site must have a program to establish, implement, and maintain written procedures for each AMP described in the AREVA UFSAR. The program must include provisions for changing AMP elements, as necessary, and within the limitations of the approved licensing bases, to address new information on aging effects based on inspection findings and/or industry operating experience during the renewal period. Another CoC change would extend these requirements to NUHOMS® System users at new reactors licensed under the NRC's regulations.

As documented in its Safety Evaluation Report (SER), the NRC staff performed a detailed safety evaluation of the proposed CoC renewal request. There are no significant changes to cask design requirements in the proposed CoC renewal. Considering the specific design requirements for each accident or sabotage condition, the design of the cask would prevent loss of containment, shielding, and criticality control in the event of an accident or sabotage. This renewal does not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposure or offsite dose rates from the implementation of the renewal of the initial certificate and these amendments would remain well within the NRC's 10 CFR part 20 limits on doses to workers and members of the public. There will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents.

This direct final rule revises the NUHOMS® System listing in 10 CFR 72.214 by renewing for an additional 40-year period the initial certificate and Amendment Nos. 1 through 11, 13, and 14 of CoC No. 1004. The renewal consists of the changes previously described, as set forth in the renewed CoC and TSs. The revised TSs are identified in the SER.

The NRC has determined that the NUHOMS® System cask design, when used under the conditions specified in the renewed CoC, renewed TSs, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load spent nuclear fuel into NUHOMS® System casks that meet the criteria of the renewed initial certificate and Amendment Nos. 1 through 11, 13, and 14 of CoC No. 1004 under 10 CFR 72.212.

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the NUHOMS® System design listed in § 72.214, “List of approved spent fuel storage casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR. Although an Agreement State may not adopt program elements reserved to the NRC, and the Category “NRC” does not confer regulatory authority on the State, the State may wish to inform its licensees of certain requirements by means consistent with the particular State's administrative procedure laws.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

The action is to amend 10 CFR 72.214 to revise the NUHOMS® System listing within the “List of approved spent fuel storage casks” to renew, for an additional 40-year period, the initial certificate and Amendment Nos. 1 through 11, 13, and 14 of CoC No. 1004. This action does not revise the authorized contents of existing or planned NUHOMS® Systems. Specifically, these changes require, among other things, that all future amendments and revisions to this CoC include evaluations of the impacts on aging management activities (i.e., time-limited aging analyses and AMPs) to ensure that they remain adequate for any changes to spent fuel storage cask SSCs within the scope of the renewal. Each general licensee using a NUHOMS® System at a reactor site must have a program to establish, implement, and maintain written procedures for each AMP described in the AREVA UFSAR. The program must include provisions for changing AMP elements, as necessary, and, within the limitations of the approved licensing bases, to address new information on aging effects based on inspection findings and/or industry operating experience during the renewal period. Another CoC change would extend these requirements to NUHOMS® System users at new reactors licensed under 10 CFR part 52.

This direct final rule is necessary to authorize the continued use of the NUHOMS® System design by power reactor licensees for dry spent fuel storage at reactor sites. Specifically, this rule extends the expiration date for the NUHOMS® System certificates for an additional 40 years, allowing a reactor licensee to continue using them under general license provisions in an independent spent fuel storage installation (ISFSI), the facility at which a holder of a power reactor operating license stores spent fuel in dry casks in accordance with 10 CFR part 72.

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the environmental assessment (EA) for the 1990 final rule. The EA for these renewals tiers off of the EA for the July 18, 1990, final rule. Tiering on past EAs is a standard process under the National Environmental Policy Act of 1969, as amended (NEPA).

The NRC staff has determined that the environmental impacts of renewing the NUHOMS® System certificates for an additional 40 years remain bounded by the EA for the 1990 final rule. As required by 10 CFR 72.240, applications for renewal of a spent fuel storage CoC design are required to demonstrate, in time-limited aging analyses and a description of an AMP, that SSCs important to safety will continue to perform their intended function for the requested renewal term. As discussed in the NRC staff's SER for the renewal of the NUHOMS® System certificates, the NRC staff has approved conditions in the renewed CoCs requiring the general licensee to implement the AMPs described in the renewal application and incorporated into the storage system's UFSAR. These conditions ensure that NUHOMS® Systems will continue to perform their intended safety functions and provide adequate protection of public health and safety throughout the renewal period.

Incremental impacts from continued use of NUHOMS® Systems under a general license for an additional 40 years are not considered significant. When the general licensee follows all procedures and administrative controls, including the conditions established as a result of the renewals, no effluents are expected from the sealed dry storage cask systems. Activities associated with cask loading and decontamination may result in some small incremental liquid and gaseous effluents, but these activities will be conducted under 10 CFR parts 50 or 52 reactor operating licenses, and effluents will be controlled within existing reactor site technical specifications. Because reactor sites are relatively large, any incremental offsite doses due to direct radiation exposure from the spent fuel storage casks are expected to be small, and when combined with the contribution from reactor operations, well within the annual dose equivalent of 0.25 mSv (25 mrem) limit to the whole body specified in 10 CFR 72.104. Incremental impacts on collective occupational exposures due to dry cask spent fuel storage are expected to be only a small fraction of the exposures from operation of the nuclear power station.

The NUHOMS® Systems are also designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an ISFSI include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

During the promulgation of the amendments that added subpart K to 10 CFR part 72 (55 FR 29181; July 18, 1990), the NRC staff assessed the public health consequences of dry cask system storage accidents and sabotage events. In the supporting analyses for these amendments, the NRC staff determined that a release from a dry cask storage system would be comparable in magnitude to a release from the same quantity of fuel in a spent fuel storage pool. As a result of these evaluations, the NRC staff determined that, because of the physical characteristics of the storage casks and conditions of storage that include specific security provisions, the potential risk to public health and safety due to accidents or sabotage is very small.

Considering the specific design requirements for each accident or sabotage condition, the design of the cask would prevent loss of confinement, shielding, and criticality control. If there is no loss of confinement, shielding, or criticality control, the environmental impacts would be insignificant.

There are no changes to cask design or fabrication requirements in the renewed initial certificate or the renewed Amendment Nos. 1 through 11, 13, and 14 that would result in an increase in occupational exposure or offsite dose rates from the implementation of the renewal of the initial certificate and amendments. Therefore, the occupational exposure or offsite dose rates would remain well within applicable 10 CFR part 20 limits.

Decommissioning of dry cask spent fuel storage systems under a general license would be carried out as part of a power reactor's site decommissioning plan. In general, decommissioning would consist of removing the spent fuel from the site, decontaminating cask surfaces, and decontaminating and dismantling the ISFSI where the casks were deployed. Under normal and off-normal operating conditions, no residual contamination is expected to be left behind on supporting structures. The incremental impacts associated with decommissioning dry cask storage installations are expected to represent a small fraction of the impacts of decommissioning an entire nuclear power station.

In summary, the proposed CoC changes will not result in any radiological or non-radiological environmental impacts that differ significantly from the environmental impacts evaluated in the EA supporting the July 18, 1990, final rule. Compliance with the requirements of 10 CFR parts 20 and 72 would ensure that adequate protection of public health and safety will continue. The NRC, in its SER for the renewal of the NUHOMS® System, has determined that if the conditions specified in the CoC to implement these regulations are met, adequate protection of public health and safety will be maintained.

Based on the previously stated assessments and its SER for the requested renewal of the NUHOMS® System certificates, the NRC has determined that the expiration date of this system in 10 CFR 72.214 can be safely extended for an additional 40 years, and that commercial nuclear power reactor licensees can continue using the system during this period under a general license without significant impacts on the human environment.

The alternative to this action is to deny approval of these renewals and end the direct final rule. Under this alternative, the NRC would either: (1) Require general licensees using NUHOMS® Systems to unload the spent fuel from these systems and either return it to a spent fuel pool or re-load it into a different NRC-approved dry storage cask system listed in 10 CFR 72.214; or (2) require that users of existing NUHOMS® Systems request site-specific licensing proceedings to continue storage in these systems.

The environmental impacts of requiring the licensee to unload the spent fuel and either return it to the spent fuel pool or re-load it into another NRC-approved dry storage cask system would result in increased radiological doses to workers. These increased doses would be due primarily to direct radiation from the casks while the workers unloaded, transferred, and re-loaded the spent fuel. These activities would consist of transferring the dry storage canisters to a cask handling building, opening the canister lid welds, returning the canister to a spent fuel pool or dry transfer facility, removing the fuel assemblies, and re-loading them, either into a spent fuel pool storage rack or another NRC-approved dry storage cask system. In addition to the increased occupational doses to workers, these activities may also result in additional liquid or gaseous effluents.

Alternatively, users of the dry cask storage system would need to apply for a site-specific license. Under this option for implementing the no-action alternative, interested licensees would have to prepare, and the NRC would have to review, each separate license application, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

In summary, the no-action alternative would entail either more environmental impacts from transferring the spent fuel now in NUHOMS® Systems, or impacts from multiple licensing actions that, in the aggregate, are likely to be less than spent fuel transfer activities but the same as, or more likely greater than, the preferred action.

Approval of the renewals of the initial certificate and Amendment Nos. 1 through 11, 13, and 14 of CoC No. 1004 would result in no irreversible commitments of resources.

No agencies or persons outside the NRC were contacted in connection with the preparation of this EA.

The environmental impacts of the action have been reviewed under the requirements of NEPA, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” Based on the foregoing EA, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: TN Americas LLC, Standardized NUHOMS® Horizontal Modular Storage System, Certificate of Compliance No. 1004, Renewal of Initial Certificate and Amendment Nos. 1 through 11, 13, Revision 1, and 14,” will not have a significant effect on the human environment.

Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing collections of information were approved by the Office of Management and Budget (OMB), approval number 3150-0132.

The NRC may not conduct or sponsor, and a person is not required to respond to a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and TN Americas LLC. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in 10 CFR 72.214. On January 22, 1994 (59 FR 65898), the NRC issued a final rule that approved the NUHOMS® System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1004.

On November 4, 2014, AREVA submitted a renewal application for the initial certificate and Amendment Nos. 1 through 11, 13, and 14 for the Standardized NUHOMS® Horizontal Modular Storage System, CoC No. 1004, for a period of 40 years beyond the initial certificate term. AREVA supplemented its request on October 16, 2015, June 6, 2016, and September 29, 2016. These requests are described in Section IV of this document, “Discussion of Changes.” Because AREVA filed its renewal application at least 30 days before the certificate expiration date of January 23, 2015, pursuant to the timely renewal provisions in 10 CFR 72.240(b), the initial certificate and Amendment Nos. 1 through 11, 13, and 14 of CoC No. 1004 did not expire.

The alternative to this action is to deny approval of the renewal of the initial certificate and Amendment Nos. 1 through 11, 13, and 14 of CoC No. 1004 and end this direct final rule. Under this alternative, the NRC would either: (1) Require general licensees using NUHOMS® Systems to unload spent fuel from these systems and return it to a spent fuel pool or re-load it into a different NRC-approved dry storage cask system listed in 10 CFR 72.214; or (2) require that users of existing NUHOMS® Systems request site-specific licensing proceedings to continue storage in these systems. Therefore, the no-action alternative would result in a significant burden on licensees and an additional inspection or licensing caseload on the NRC. In addition, the no action alternative would entail either more environmental impacts from transferring the spent fuel now in NUHOMS® Systems, or impacts from multiple licensing actions that, in the aggregate, are likely to be less than spent fuel transfer activities but the same as, or more likely greater than, the preferred action.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the SER and the EA, this direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.

The NRC has determined that the actions in this direct final rule do not require a backfit analysis because they either do not fall within the definition of backfitting under 10 CFR 72.62 or 10 CFR 50.109(a)(1), or they do not impact any general licensees currently using these systems. Additionally, the actions in this direct final rule do not impact issue finality provisions applicable to combined licenses under 10 CFR part 52.

This direct final rule renews CoC No. 1004 for the NUHOMS® System, as currently listed in 10 CFR 72.214, “List of approved spent fuel storage casks,” to extend the expiration date of the initial certificate and Amendment Nos. 1 through 11, 13, and 14 by 40 years. The renewed certificates would require implementation of an AMP for the 40 years after the storage cask system's initial 20-year service period.

Renewing these certificates does not fall within the definition of backfit under 10 CFR 72.62 or 10 CFR 50.109, or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Extending the certificates' effective dates for 40 more years and requiring the implementation of AMPs does not impose any modification or addition to the design of an SSC of a cask system, or to the procedures or organization required to operate the system during the initial 20-year storage period of the system, as authorized by the current certificate.

General licensees that have loaded these casks, or that load these casks in the future under the specifications of the applicable certificate, may continue to store spent fuel in these systems for the initial 20-year storage period authorized by the original certificate. The AMPs required to be implemented by this renewal are only required to be implemented after the storage cask system's initial 20-year service period ends. As explained in the 2011 final rule that amended 10 CFR part 72 (76 FR 8872, Question I; February 16, 2011), the general licensee's authority to use a particular storage cask design under an approved CoC terminates 20 years after the date that the general licensee first loads the particular cask with spent fuel, unless the cask's CoC is renewed. Because this rulemaking renews the certificates, and renewal is a separate NRC licensing action voluntarily implemented by vendors, the renewal of these CoCs is not an imposition of new or changed requirements from which these licensees would otherwise be protected by the backfitting provisions in 10 CFR 72.62 or 10 CFR 50.109.

Even if renewal of this CoC system could be considered a backfit, TN Americas LLC, as the holder of the CoC and vendor of the casks, is not protected by the backfitting provisions in 10 CFR 72.62.

Unlike a vendor, general licensees using the existing systems subject to these renewals would be protected by the backfitting provisions in 10 CFR 72.62 and 10 CFR 50.109 if the renewals constituted new or changed requirements. But as previously explained, renewal of the certificates for these systems does not impose such requirements. The general licensees using these CoCs may continue storing material in their respective cask systems for the initial 20-year storage period identified in the applicable certificate or amendment with no changes. If general licensees choose to continue to store spent fuel in NUHOMS® Systems after the initial 20-year period, these general licensees will be required to implement AMPs for any cask systems subject to a renewed CoC, but such continued use is voluntary.

For these reasons, renewing the initial certificate and Amendment Nos. 1 through 11, 13, and 14 of CoC No. 1004 does not constitute backfitting under 10 CFR 72.62 or 10 CFR 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC staff has not prepared a backfit analysis for this rulemaking.

This direct final rule is not a rule as defined in the Congressional Review Act (5 U.S.C. 801-808).

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

The NRC may post materials related to this document, including public comments, on the Federal Rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2017-0138. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2017-0138); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:

Effective October 1, 2000, SBA adopted NAICS 1997 industry definitions as a basis for its table of small business size standards, replacing the 1987 Standard Industrial Classification (SIC) (65 FR 30836 (May 15, 2000)). Since then, OMB has issued four revisions to NAICS. SBA's table of size standards adopted the OMB's first revision, NAICS 2002, effective October 1, 2002 (67 FR 52597 (August 13, 2002)), the second revision, NAICS 2007, effective October 1, 2007 (72 FR 49639 (August 29, 2007)), and the third revision, NAICS 2012, effective October 1, 2012 (77 FR 49991 (August 20, 2012)).

OMB published its fourth and latest revision, NAICS 2017, “Notice of NAICS 2017 final decisions” in the Federal Register on August 8, 2016 (81 FR 52584). The OMB notice stated that Federal statistical establishment data published for reference years beginning on or after January 1, 2017, should be published using NAICS 2017.

As with the previous NAICS revisions, SBA is adopting the NAICS 2017 revision at the beginning of the new fiscal year (October 1, 2017) following the OMB's release of the NAICS revision for reasons as set forth under the Justification for the October 1, 2017 Effective Date section, below:

NAICS 2017 created 21 new NAICS industries by reclassifying, splitting, or merging 29 industries or their parts under NAICS 2012. Of those 21 new industries, five were created by merging two or more of thirteen NAICS 2012 industries in their entirety, while three were created by combining part of one industry with another industry. Three new industries were created by splitting two industries to two parts each with one part of each industry defined as a separate industry and combining other parts of the two industries to form a separate new industry. One new industry was formed by designating part of one industry as a separate industry. OMB also changed 6-digit NAICS codes for eight industries without changing their definitions and titles and amended the title of one industry without changing its 6-digit code. Table 1, “NAICS 2012 Industries or Their Parts Matched to NAICS 2017 Industries,” below, shows the changes from NAICS 2012 to NAICS 2017.

Complete information on the relationship between NAICS 2012 and NAICS 2017 is available on the U.S. Bureau of the Census (Census Bureau) Web site at http://www.census.gov/eos/www/naics/. The Census Bureau's Web site also provides detailed documentation on Federal notices involving the replacement of SIC with NAICS, and all subsequent NAICS updates and revisions, including the August 8, 2016 “Notice of NAICS 2017 final decisions,” as well as concordances (i.e., correspondence tables) between SIC and NAICS 1997 and NAICS 2002, and between subsequent NAICS revisions.

On October 22, 1999, SBA proposed to replace SIC with NAICS 1997 as the basis of industry definitions for its table of small business size standards (64 FR 57188). The proposed rule included a set of guidelines or rules that SBA applied to convert the size standards for industries under SIC to NAICS. The guidelines aimed to minimize the impact of applying a new industry classification system on SBA's size standards and on small businesses that qualified as small under the SIC based size standards. SBA received no negative comments against the proposed guidelines. SBA published its final rule on May 15, 2000 (65 FR 30386) (corrected on September 5, 2000, 65 FR 53533) adopting the resulting table of size standards based on NAICS 1997, as proposed. To be consistent, SBA used the same guidelines when it updated its table of size standards to adopt NAICS 2002, NAICS 2007, and NAICS 2012 revisions. In those updates as well, SBA received no adverse comments on using those guidelines, or on the resulting changes to the size standards. For the April 18, 2017 proposed rule to adopt NAICS 2017 for its size standards table, SBA also generally followed the same guidelines, as shown below in Table 2, “General Guidelines to Establish Size Standards for New Industries under NAICS 2017.”

In addition to the above general guidelines, in cases where a new industry is formed by merging multiple industries or their parts with substantially different levels or different measures of size standards, as detailed in the April 18, 2017 proposed rule, SBA also examined the relevant latest industry and Federal procurement data to determine an appropriate size standard for the new industry. Developed based on the above guidelines and analyses of the relevant data, where necessary, SBA's size standards for the new industries under NAICS 2017 are shown in Table 3, “Size Standards for New Industries in NAICS 2017.” Also shown in the table are the current size standards for the affected NAICS 2012 industries and their parts.

As shown in Table 3, the size standards for most of the affected NAICS 2012 industries are not impacted and therefore remain unchanged under NAICS 2017. The majority of the changes consist of revisions to industry codes or titles, or mergers of two or more NAICS 2012 industries or their parts to new industries without impacting their size standards. Of the 29 NAICS 2012 industries affected by the revision, adopting NAICS 2017 increases size standards for six industries and part of one industry and decreases for two. This would also result in changing the size standard measure for one industry from average annual receipts to number of employees. Size standards for twenty industries and part of one industry do not change.

For the April 18, 2017 proposed rule, SBA provided a 60-day comment period for the public to comment on proposed changes to size standards from the adoption of the NAICS 2017, which ended on June 19, 2017. SBA received three comments to the proposed rule, two of which were outside the scope of the proposed rule as discussed below.

One commenter recommended that SBA change the size standard for the Military and Aerospace Equipment and Military Weapons exception to NAICS 541330 (Engineering Services) from average annual revenues to the number of employees.

Discussion

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes; and Model C-295 airplanes. The SNPRM published in the Federal Register on June 21, 2017 (82 FR 28274) (“the SNPRM”). We preceded the SNPRM with a notice of proposed rulemaking that published in the Federal Register on November 25, 2016 (81 FR 85169) (“the NPRM”). The NPRM proposed to require an inspection of motorized cross-feed fuel valves and, depending on findings, applicable corrective action(s). The NPRM was prompted by leakage of a motorized cross-feed fuel valve. The SNPRM proposed to require a reduced compliance time for the initial inspection, the addition of repetitive inspections and operational checks, and corrective actions if necessary. We are issuing this AD to detect and correct leaks in a motorized fuel valve, which could lead to failure of the fuel valve and consequent improper fuel system functioning or, in case of the presence of an ignition source, an airplane fire.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0004, dated January 9, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes; and Model C-295 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9386.

We gave the public the opportunity to participate in developing this AD. We received no comments on the SNPRM or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM.

Airbus Defense and Space has issued Alert Operators Transmission (AOT) AOT-C295-28-0001, Revision 1, dated September 27, 2016; and AOT-CN235-28-0001, Revision 1, dated September 27, 2016. This service information describes procedures for repetitive inspections, replacement of the motorized fuel valves, and operational checks and corrective actions on affected motorized fuel valves. These documents are distinct since they apply to different airplane models. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 14 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that will be required based on the results of the required inspection. We have no way of determining the number of aircraft that might need these replacements:

We have received no definitive data that will enable us to provide cost estimates for the on-condition corrective actions for the operational check specified in this AD.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model DHC-8-401 and -402 airplanes. The SNPRM published in the Federal Register on July 14, 2017 (82 FR 32496) (“the SNPRM”). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on January 13, 2016 (81 FR 1586) (“the NPRM”). The NPRM proposed to require replacement of affected spoiler PCUs. The NPRM was prompted by the discovery of cracking on two test spoiler PCU manifolds during testing by the manufacturer. The SNPRM proposed to require replacement of affected spoiler PCUs, and also proposed to add airplanes to the applicability. We are issuing this AD to prevent cracking of the spoiler PCUs that could lead to the loss of multiple flight controls and landing gear systems.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2015-07R2, dated December 14, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model DHC-8-401 and -402 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8434.

We gave the public the opportunity to participate in developing this AD. We received no comments on the SNPRM or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM.

Bombardier, Inc., has issued Service Bulletin 84-27-64, Revision A, dated July 26, 2016. This service information describes procedures for replacement of affected spoiler PCU manifolds.

Parker-Hannifin Corporation has issued Service Bulletin 390700-27-002, Revision 1, dated April 13, 2016. This service bulletin identifies affected spoiler PCUs.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 82 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-26-10, Amendment 39-18061 (80 FR 2813, January 21, 2015) (“AD 2014-26-10”). AD 2014-26-10 applied to all Airbus Model A318, A319, A320, and A321 series airplanes. The NPRM published in the Federal Register on April 13, 2017 (82 FR 17770). The NPRM was prompted by a determination that more restrictive maintenance instructions and airworthiness limitations are necessary. The NPRM proposed to require revising the maintenance or inspection program, as applicable, to incorporate new or revised airworthiness limitation requirements. The NPRM also proposed to remove airplanes from the applicability. We are issuing this AD to mitigate the risks associated with aging effects of airplane systems. Such aging effects could change the characteristics of the systems leading to an increased potential for failure, which could result in failure of certain life-limited parts, and reduced structural integrity or reduced controllability of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2016-0093, dated May 13, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A318, A319, A320, and A321 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0248.

We gave the public the opportunity to participate in developing this AD. We considered the comments received. Camp Systems International, Daniel Systems Inc., and United Airlines supported the NPRM.

American Airlines (AAL) asked that a provision be incorporated into the proposed AD to approve use of Airbus A318/A319/A320/A321 ALS Part 4, “System Equipment Maintenance Requirements (SEMR)”, Revision 05, dated April 6, 2017 (“ALS Part 4, Revision 05”), as an additional means of compliance with the maintenance or inspection program. AAL stated that ALS Part 4, Revision 05 is the latest revision level for ALS Part 4, and approving it would potentially alleviate a future alternative method of compliance (AMOC) request.

We acknowledge the commenter's concern. We have issued global AMOCs to AD 2014-26-10, which allow all operators of U.S.-registered airplanes to use Airbus A318/A319/A320/A321 ALS Part 4, “System Equipment Maintenance Requirements (SEMR)”, Revision 04, dated July 6, 2016, and Airbus A318/A319/A320/A321 ALS Part 4, “System Equipment Maintenance Requirements (SEMR)”, Revision 05, dated April 6, 2017. These AMOCs are included in paragraph (k)(1)(ii) of this AD, which states that AMOCs approved previously for AD 2014-26-10 are approved as AMOCs for the corresponding provisions of paragraph (g) of this AD. In addition, these AMOCs are also applicable to the revision required by paragraph (i) of this AD. Therefore, we have added paragraph (k)(1)(iii) to this AD to specify the previous AMOCs that are approved for the provisions of paragraph (i) of this AD.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting this AD with the change described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Airbus has issued Airbus A318/A319/A320/A321 ALS Part 4, “System Equipment Maintenance Requirements (SEMR),” Revision 03 at Issue 02, dated January 22, 2016. This service information describes preventive maintenance requirements and includes updated inspections and intervals to be incorporated into the maintenance or inspection program. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 1,032 airplanes of U.S. registry.

The actions required by AD 2014-26-10, and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 2014-26-10 is $85 per product.

We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $87,720, or $85 per product.

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

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

This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities the various levels of government.

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

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2015-15-10, Amendment 39-18219 (80 FR 43928, July 24, 2015) (“AD 2015-15-10”). AD 2015-15-10 applied to all Airbus Model A318, A319, A320, and A321 series airplanes. The NPRM published in the Federal Register on June 2, 2017 (82 FR 25542). The NPRM was prompted by the establishment of an additional life limit for the THSA, based on flight cycles. The NPRM proposed to require repetitive detailed inspections of certain THSAs, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct wear of the THSA, which could reduce the remaining life of the THSA, possibly resulting in premature failure and consequent reduced controllability of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2016-0184, dated September 13, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A318 and A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0498.

We gave the public the opportunity to participate in developing this AD. We considered the comments received. Air Line Pilots Association, International (ALPA) and United Airlines expressed their support for the NPRM.

The NPRM specified that a THSA that had been repaired in-shop as specified in UTAS Component Maintenance Manual 27-44-51 would be an equivalent method of compliance for the initial inspection required by paragraph (h) of this AD. We have revised paragraph (m) of this AD to specify that a THSA that has been repaired in-shop using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or the EASA; or Airbus's EASA Design Organization Approval (DOA), is acceptable for compliance with the initial inspection required by paragraph (h) of this AD. We have also added Note 1 to paragraph (m) of this AD to reference UTAS Component Maintenance Manual 27-44-51 as an additional source of guidance for the in-shop repair of the THSA.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Airbus has issued Service Bulletin A320-27-1227, Revision 03, dated April 29, 2016. This service information describes procedures for repetitive special detailed inspections for wear of the THSA, and related investigative and corrective actions.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 1,182 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Discussion

On June 15, 2017, we issued AD 2017-13-05, Amendment 39-18935 (82 FR 34251, July 24, 2017) (“AD 2017-13-05”), which applied to all Airbus Model A330-200, A330-300, A340-200, A340-300, A340-500, and A340-600 series airplanes. AD 2017-13-05 was prompted by the need for a modification that automatically detects failure of the ball-screw assembly. AD 2017-13-05 required an inspection, corrective actions if necessary, lubrication of the ball-nut, modification of the trimmable horizontal stabilizer actuator (THSA), and additional work for previously modified airplanes. For certain airplanes, AD 2017-13-05 required installation of an electronic harness, terminating actions, and a ball-screw assembly inspection. We issued AD 2017-13-05 to detect and correct wear on the THSA, possibly resulting in damage to the ball-screw and fail-safe nut, which could jam the THSA and result in reduced control of the airplane.

Since we issued AD 2017-13-05, we have received reports indicating that affected parties could misinterpret the identity of applicable service information to use for the modification, due to the formatting of figure 2 to paragraphs (h) and (i) in the published version of AD 2017-13-05. Since the published figure could result in a negative effect on compliance, we have determined that clarification of the formatting of the published figure is necessary.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2014-0219, dated September 29, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330 and Model A340 series airplanes. (Model A330-223F and A330-243F airplanes were removed from AD 2017-13-05 to correspond with the MCAI.) The EASA AD is referenced in AD 2017-13-05. EASA has not revised its AD since the issuance of AD 2017-13-05.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0813.

Airbus has issued the following service information. The service bulletins having the same document number (but different revision levels) are distinct because each revision contains unique editorial changes.

The following service information describes procedures for doing repetitive inspections for integrity of the primary and secondary load paths of the ball-screw assembly of the THSA. These service bulletins are distinct because they apply to different airplane models.

• Airbus Service Bulletin A330-27-3102, Revision 09, dated March 29, 2016.

• Airbus Service Bulletin A340-27-4107, Revision 09, dated March 29, 2016.

The following service information describes procedures for installing two electrical detection devices, also called CSPs, on the lower attachment secondary load path of the THSA, and modifying the THSA. These service bulletins are distinct because they apply to different airplane models equipped with THSAs having different part numbers.

• Airbus Service Bulletin A330-27-3137, including Appendix 01, dated March 20, 2007.

• Airbus Service Bulletin A330-27-3137, Revision 01, including Appendix 1, dated December 6, 2007.

• Airbus Service Bulletin A330-27-3137, Revision 02, dated January 18, 2010.

• Airbus Service Bulletin A330-27-3143, Revision 01, dated July 10, 2012.

• Airbus Service Bulletin A340-27-4136, including Appendix 01, dated March 20, 2007.

• Airbus Service Bulletin A340-27-4136, Revision 01, including Appendix 1, dated December 6, 2007.

• Airbus Service Bulletin A340-27-4136, Revision 02, including Appendix 1, dated February 24, 2010.

• Airbus Service Bulletin A340-27-4143, dated February 21, 2012.

• Airbus Service Bulletin A340-27-5030, Revision 01, including Appendix 1, dated November 20, 2009.

The following service information describes procedures for installing electrical wiring harnesses and brackets to connect the secondary nut detection device to the monitoring systems. These service bulletins are distinct because they apply to different airplane models.

• Airbus Service Bulletin A330-92-3046, Revision 04, dated July 16, 2010.

• Airbus Service Bulletin A330-92-3046, Revision 05, dated November 7, 2011.

• Airbus Service Bulletin A330-92-3046, Revision 07, dated January 13, 2017.

• Airbus Service Bulletin A340-92-4056, Revision 03, dated July 16, 2010.

• Airbus Service Bulletin A340-92-4056, Revision 04, dated December 5, 2013.

• Airbus Service Bulletin A340-92-5008, Revision 07, dated February 8, 2013.

The following service information describes system equipment maintenance requirements (SEMR) that refer to preventative maintenance requirements found necessary to comply with safety objectives. These documents are distinct because they apply to different airplane models.

• Airbus A330 Airworthiness Limitations Section (ALS) Part 4—System Equipment Maintenance Requirements (SEMR), Revision 05, dated October 19, 2015.

• Airbus A340 Airworthiness Limitations Section (ALS) Part 4—System Equipment Maintenance Requirements (SEMR), Revision 04, dated October 19, 2015.

• Airbus A340 Airworthiness Limitations Section (ALS) Part 3—Certification Maintenance Requirements (CMR), Revision 03, dated October 19, 2015, describes CMRs that are system-related periodic tasks established during type certification.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

We are superseding AD 2017-13-05 to clarify the formatting of a figure in the regulatory text of the published AD. No other changes have been made to AD 2017-13-05. Therefore, we determined that notice and opportunity for prior public comment are unnecessary.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-0813; Product Identifier 2017-NM-109-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

We estimate that this AD affects 33 airplanes of U.S. registry. This AD adds no new economic burden to AD 2017-13-05.

We estimate that it takes about 68 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $17,481 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $764,808, or $23,260 per product.

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Leesville City Airport, Leesville, LA and Harry P. Williams Memorial Airport, Patterson, LA, to support standard instrument approach procedures for IFR operations at the airport.

On April 10, 2017, the FAA published in the Federal Register (82 FR 17160) Docket No. FAA-2017-0183, a notice of proposed rulemaking (NPRM) to amend Class E airspace extending upward from 700 feet above the surface at:

Leesville Airport, Leesville, LA, and Harry P. Williams Memorial Airport, Patterson, LA, due to the decommissioning of the Leesville NBD and Patterson RBN.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Subsequent to publication, the FAA realized that it had inadvertently failed to include updates to the geographic coordinates for Harry P. Williams Memorial Airport, to coincide with the FAA's aeronautical database in the NPRM. Those geographic coordinates are updated in this final rule.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at:

Leesville Airport, Leesville, LA, to within a 6.4-mile radius (reduced from a 6.5-mile radius) of Leesville Airport, and within 3.7 miles each side of the 360° bearing from the airport (modified from 3.6 miles from each side of the 345° bearing) extending from the 6.4-mile radius (reduced from a 6.5-mile radius) to 12.3 miles (increased from 12.2 miles) north of the airport, and removing the segment within 2.5 miles each side of the 000° bearing of the Leesville NDB extending from the 6.5-mile radius to 7.3 miles north of the airport; and

Harry P. Williams Memorial Airport, Patterson, LA, by removing the segment within 2.5 mile each side of the 233° bearing from the Patterson RBN extending from the 6.5-mile radius to 7.5 miles southwest of the airport. Additionally, the geographic coordinates for Harry P. Williams Memorial Airport, are adjusted to coincide with the FAA's aeronautical database.

Airspace reconfiguration is necessary due to the decommissioning of the Leesville NBD and Patterson RBN, and cancellation of the navigation aid approaches at these airports. Controlled airspace is necessary for the safety and management of standard instrument approach procedures for IFR operations at these airports.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Midland International Air Space Port Airport by removing Mabee Ranch Airport, Midland, TX, due to closing of the airport; and establishes Class E airspace at Odessa Airport-Schlemeyer Field, Odessa, TX, and Midland Airpark, Midland, TX, to support special instrument approach procedures for IFR operations at these airports.

On May 26, 2017, the FAA published in the Federal Register (82 FR 24266) Docket No. FAA-2016-9481, a notice of proposed rulemaking (NPRM) to amend Class E airspace at Midland International Air and Space Port Airport, Midland, TX; and establish Class E airspace extending upward from 700 feet above the surface at Odessa Airport-Schlemeyer Field, Odessa, TX, and Midland Airpark, Midland, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002, and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies: Class E airspace extending upward from 700 feet above the surface to within a 7.1-mile radius (from a 17.4-mile radius) of Midland International Air and Space Port Airport, Midland, TX, and also amends the airport name from Midland International Airport to Midland International Air and Space Port Airport in this and other associated Class E airspace areas. Airspace reconfiguration is necessary due to the closing of Mabee Ranch Airport, and decommissioning and cancellation of the Mabee NDB and NDB approaches.

This action also established Class E airspace extending upward from 700 feet above the surface within a 6.6-mile radius of both Midland Airpark, Midland, TX and Odessa Airport-Schlemeyer Field, Odessa, TX, to accommodate special instrument approach procedures for IFR operations at these airports.

Additionally, this action makes an editorial change in the legal description by replacing Airport/Facility Directory with the term Chart Supplement in the Class E surface area airspace.

Class E airspace areas are published in Paragraph 6002 and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; 2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

I. Introduction

In 2015, the Commission adopted a rule 1 to implement the pay ratio disclosure requirement 2 mandated by Section 953(b) of the Dodd-Frank Wall Street Reform and Consumer Protection Act.3 In doing so, the Commission stated its belief that, in order for the data points provided by the rule to be of use to investors, the pay ratio rule “should be designed to allow shareholders to better understand and assess a particular registrant's compensation practices and pay ratio disclosures rather than to facilitate a comparison of this information from one registrant to another.” 4 Consistent with this view, the Commission stated that it sought to provide flexibility in a manner that would “reduce costs and burdens for registrants while preserving what we perceive to be the purpose and intended benefits” of the statutorily mandated disclosure.5 Under the final rule, registrants must provide pay ratio disclosure for the first fiscal year beginning on or after January 1, 2017, which means that registrants will begin making pay ratio disclosures in early 2018.

In light of the approaching compliance date and concerns raised about the implementation of the disclosure requirement,6 this release provides additional guidance to assist registrants in their compliance efforts. In addition, the Commission staff is publishing guidance about the use of statistical sampling to assist registrants in determining their median employee for purposes of the pay ratio disclosure.7

The pay ratio rule affords significant flexibility to registrants in determining appropriate methodologies to identify the median employee and calculating the median employee's annual total compensation.8 Required disclosure may be based on a registrant's reasonable belief; use of reasonable estimates, assumptions, and methodologies; and reasonable efforts to prepare the disclosures.9 Specifically, the rule permits registrants to use reasonable estimates to identify the median employee, including by using statistical sampling and a consistently applied compensation measure (such as payroll or tax records).10 The rule also allows registrants to use reasonable estimates in calculating the annual total compensation or any elements of annual total compensation for employees.11 The rule further provides that if a registrant changes its methodology or its material assumptions, adjustments, or estimates, and the effects are significant, the registrant must briefly describe the change and the reasons for the change.12

In light of the use of estimates, assumptions, adjustments, and statistical sampling permitted by the rule, pay ratio disclosures may involve a degree of imprecision. This has led some commenters to express concerns about compliance uncertainty and potential liability.13 In our view, if a registrant uses reasonable estimates, assumptions or methodologies, the pay ratio and related disclosure that results from such use would not provide the basis for Commission enforcement action unless the disclosure was made or reaffirmed without a reasonable basis or was provided other than in good faith.

Item 402(u) requires a registrant to disclose the median of the annual total compensation of all its employees excluding its principal executive officer.14 We are providing guidance as to the use of existing internal records, such as tax or payroll records, to make this determination.

The final rule defines the term “employee” to include U.S. employees and employees located in a jurisdiction outside the United States (“non-U.S. employees”). In the Pay Ratio Release, we acknowledged that the inclusion of non-U.S. employees would raise compliance costs for multinational companies.15 To address concerns about compliance costs, the rule permits registrants to exempt non-U.S. employees where these employees account for 5% or less of the registrant's total U.S. and non-U.S. employees, with certain limitations.16 We are clarifying that a registrant may use appropriate existing internal records, such as tax or payroll records, in determining whether the 5% de minimis exemption is available.17

We also believe that the use of existing internal records may, in many circumstances, be appropriate in identifying a registrant's median employee. Instruction 4 to Item 402(u) permits a registrant to identify its median employee using a consistently applied compensation measure, such as information derived from the registrant's tax or payroll records. We are clarifying that a registrant may use internal records that reasonably reflect annual compensation to identify the median employee, even if those records do not include every element of compensation, such as equity awards widely distributed to employees.

We recognize that, when calculating total compensation in accordance with Item 402(c)(2)(x) for the identified median employee that the registrant identified using a consistently applied compensation measure based on internal records, the registrant may determine that there are anomalous characteristics of the identified median employee's compensation that have a significant higher or lower impact on the pay ratio. The Commission discussed this issue in the adopting release specifically and noted that, in such a circumstance, instead of concluding that the consistently applied compensation measure the registrant used was unsuitable to identify its median employee, the registrant may substitute another employee with substantially similar compensation to the original identified median employee based on the compensation measure it used to select the median employee.18

For purposes of Item 402(u), the term “employee” or “employee of the registrant” is defined as “an individual employed by the registrant or any of its consolidated subsidiaries.” 19 Item 402(u)(3) excludes from the definition those workers who are employed, and whose compensation is determined, by an unaffiliated third party but who provide services to the registrant or its consolidated subsidiaries as independent contractors or “leased” workers.20 In the Pay Ratio Release, the Commission indicated that excluding these workers is appropriate, because registrants generally do not control the level of compensation that these workers are paid.21

Some commenters have expressed concerns about the application of the rule's definition of “employee.” 22 Because registrants already make determinations as to whether a worker is an employee or independent contractor in other legal and regulatory contexts, such as for employment law or tax purposes, some commenters suggested that the Commission should allow registrants to use widely recognized tests to determine who is an “employee” for purposes of the rule.23 Such a test might, for example, be drawn from guidance published by the Internal Revenue Service with respect to independent contractors.24

Item 402(u)(3) makes clear that an “employee” is an individual employed by the registrant.25 The provision in Item 402(u)(3) indicating that the definition of “employee” does not include workers who are employed, and whose compensation is determined, by an unaffiliated third party describes one category of workers that is expressly excluded from the definition of “employee” under the rule. The provision was not intended to serve as an exclusive basis for determining whether a worker is an employee of the registrant. Accordingly, we believe it would be consistent with Item 402(u) for a registrant to apply a widely recognized test under another area of law that the registrant otherwise uses to determine whether its workers are employees.26

This document contains final regulations in Title 26 of the Code of Federal Regulations under section 3402 of the Internal Revenue Code (Code). The final regulations amend, update, and clarify the existing withholding and information reporting requirements for certain gambling winnings under § 31.3402(q)-1 of the Employment Tax Regulations, and make conforming changes to § 31.3406(g)-2.

On December 30, 2016, the Treasury Department and the IRS published a notice of proposed rulemaking (REG-123841-16) in the Federal Register, 81 FR 96406, containing proposed regulations that would provide a new rule regarding how payers determine the amount of the wager in parimutuel wagering transactions with respect to horse races, dog races, and jai alai, and that would update the existing rules to reflect current law regarding the withholding thresholds and certain information reporting requirements.

Over 2,700 written public comments were received in response to the notice of proposed rulemaking. No public hearing was requested. After careful consideration of the written comments, the proposed regulations are adopted as modified by this Treasury Decision.

All of the written comments on the notice of proposed rulemaking were considered and are available at www.regulations.gov or upon request. Many of these comments addressed similar issues and expressed similar points of view. These comments are summarized in this preamble.

The proposed regulations contained a new rule for determining the amount of the wager in the case of horse races, dog races, and jai alai to allow all wagers placed in a single parimutuel pool and represented on a single ticket to be aggregated and treated as a single wager. Commenters largely supported the proposed rules because they believe that the rules accurately and fairly reflect parimutuel wagering realities.

Some commenters raised concerns that the single ticket requirement in the proposed regulations did not address electronic wagering. Commenters stated that in horse racing a paper ticket can only accommodate six separate lines of bets. In contrast, electronic wagering utilizes an “account wagering” system that can accommodate dozens (or even hundreds) of lines of bets in a single parimutuel pool, allowing bettors to place more, customized wagers. As a result, some commenters requested a special rule for electronic wagering.

The proposed rule at § 31.3402(q)-1(c)(1)(ii) is specifically not limited to a paper ticket, but also includes an electronic record that is presented to collect proceeds from a wager or wagers placed in a single parimutuel pool. Therefore, the rule in proposed § 31.3402(q)-1(c)(1)(ii) is not dependent on the applicable industry's ticketing format. Further, despite the commenters concern regarding the limits on the number of lines a paper ticket can accommodate, the proposed regulations do not limit the number of bets on a single ticket nor do the proposed regulations contain a rule governing the number of bets that can be contained on a single, electronic record of a wagering transaction.

Another commenter stated that the single ticket requirement puts a person making an electronic bet at a disadvantage because it removes the opportunity to place bets in a single parimutuel pool at multiple points in time throughout the allotted time period for wagering. The single ticket rule in the proposed regulations does not differentiate between electronic betting and placing a bet at a ticket window. Therefore, the proposed rule does not put an electronic bettor at a disadvantage. However, the comment brings to light that there is some confusion regarding how the rule applies in the context of electronic betting.

The single-ticket requirement in the proposed regulations allows aggregation of wagers that are placed in the same parimutuel pool if they are represented on a single ticket. This is the case regardless of whether the ticket is paper or electronic. This requirement was included in the proposed regulations to limit the potential for fraud, such as a winning bettor collecting losing tickets from another bettor or bettors who placed bets in the same parimutuel pool to artificially increase the amount of the wager. In addition, the single-ticket requirement improves administrability because it does not require payers to collect information reflected on multiple tickets. As the preamble to the proposed regulations explains, the single ticket requirement was not intended to limit the amount of the wager to bets placed at a single point in time because a ticket containing prior bets in a single pool can be cancelled, and the original and additional wagers in that pool can be placed on a new ticket. The fraud and administrability concerns that apply to paper tickets do not apply equally to electronic records because each person's bets are reflected on a single electronic wagering account. Accordingly, electronic bettors may aggregate wagers placed at different points in time without having to cancel prior wagers and place them on a new ticket as long as the wagers meet the requirements in the proposed rule—that is, they are placed in a single parimutuel pool and are represented on a single, electronic record.

Because the comments received in response to the proposed rule do not justify any change, the final regulations adopt the proposed rule without modification.

The proposed regulations provided that final regulations would apply to payments made after the date they are published in the Federal Register. Some commenters requested a delayed effective date to allow time for industry stakeholders to update their systems and seek any necessary state regulatory approval. One commenter specficially suggested that 45 days following publication of the final regulations would be sufficient time to perform such updates. In addition, the commenters suggested that the final rules be effective for wagering transactions with respect to winning events that occur after the date that the final rules are published in the Federal Register. The Treasury Department and IRS agree with these comments. Therefore, the final regulations are applicable to reportable gambling winnings paid with respect to a winning event that occurs on or after 45 days from the date the final regulations are published in the Federal Register. If they so choose, payers may rely on the provisions of the final regulations for payments made after the date the final regulations are published in the Federal Register, regardless of when the related winning event occurred.

Several commenters raised concerns regarding the thresholds for information reporting and withholding for certain gambling winnings. Another commenter requested that the regulations provide an exception to withholding under section 3402(q). Neither the threshold for information reporting with respect to gambling winnings not subject to withholding nor exceptions to section 3402(q) withholding were the focus of the proposed regulations. In addition, the withholding thresholds are defined by statute. These comments are outside the scope of the proposed regulations, and therefore the comments have not been adopted in the final regulations.

Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required.

It is hereby certified that this rule will not have a significant economic impact on a substantial number of small entities. Although this rule may affect a substantial number of small entities, the economic impact is minimal because this rule merely provides guidance as to the statutory withholding rules and filing of information returns for payers who make reportable payments of certain gambling winnings and who are required by sections 3402 and 6041 to withhold and make returns reporting those payments. This rule reduces the existing burden on payers to comply with the statutory requirement by simplifying the process for payers to verify payees' identities with a broader range of documents that are more readily available.

This rule also will result in a reduction in the number of forms filed. Instead of treating all components of a bet made by a gambler in a single parimutuel pool as a separate amount wagered, the rules treat all amounts wagered in a single parimutuel pool reflected on a single ticket as the amount wagered for purposes of determining whether reporting or withholding is needed. For the reasons stated, the final rule will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis under the Regulatory Flexibility Act (5 U.S.C. Chapter 6) is not required.

Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on the regulations' impact on small businesses, and no comments were received.

The principal author of these regulations is David Bergman of the Office of the Associate Chief Counsel (Procedure and Administration). However, other personnel from the Treasury Department and the IRS participated in their development.

Accordingly, 26 CFR part 31 is amended as follows:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

On January 18, 2017, the Coast Guard published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (82 FR 5480) entitled “Special Local Regulation; Pago Pago Harbor, American Samoa.” In the NPRM we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this canoe race event. During the comment period that ended February 17, 2017, we received no comments.

This event will consist of a series of three single race days within Pago Pago Harbor each November and one race day in April. The event will include 50 longboats with paddling crews of 30-50 persons each. It is anticipated that a large number of spectator pleasure craft will be drawn to the event. Spectator vessels and commercial vessel traffic would pose a significant safety hazard to the longboats, longboat crew members, and other persons and vessels involved with the event due to the longboats limited maneuverability within the port. Traditionally, the event is held on Fridays, Saturdays, or holiday week days, pending when Veteran's Day falls each year, and are dependent on local weather; both factors will dictate the event days each year.

The Captain of the Port, Honolulu (COTP), is establishing a permanent special local regulation to minimize vessel traffic in Pago Pago Harbor before, during, and after the scheduled event to safeguard persons and vessels during the longboat races. A regulated area is a water area, shore area, or water and shore area, for safety or environmental purposes, of which access is limited to authorized persons, vehicles, or vessels. The statutory basis for this rulemaking is 33 U.S.C. 1233, which gives the Coast Guard, under a delegation from the Secretary of the Department of Homeland Security, regulatory authority to enforce the Ports and Waterways Safety Act.

The Captain of the Port Honolulu has determined that potential safety hazards exist to the longboats, longboat crew members, and other persons and vessels involved with the event due to the longboats limited maneuverability within the port and large amount of spectator vessels and commercial traffic drawn to the event. The purpose of this rule is to ensure safety of vessels and navigable waters in the safety zone before, during, and after the event.

As noted above, we received no comments on our NPRM published January 18, 2017. However, after the NPRM period, Coast Guard was notified by the event sponsor that an additional event occurs on April 17 annually in celebration of American Samoa's Flag Day. The Coast Guard is amending this regulation to include this event.

This rule will create a permanent special local regulation in Pago Pago Harbor. The regulated area will close the harbor to all vessels not authorized by the COTP for entry into, transiting, or anchoring within the port for the duration of the event. The COTP will authorize registered participants, support vessels, and enforcement vessels to enter and remain in the area. No other vessels will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative. The harbor will remain closed until the Coast Guard issues an “All Clear” after races have concluded and the harbor is deemed safe for normal operations. This rule will not require any vessel already moored to evacuate the port, provided they are moored in such a way that they do not interfere with the event.

The COTP will use all appropriate means to notify the public when the special local regulation in this rule will be enforced. Such means may include publication in the Federal Register a Notice of Enforcement, Broadcast Notice to Mariners, and Local Notice to Mariners. The regulatory text appears at the end of this document.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-day of the Special Local Regulation. Vessel traffic will be able to safety transit through the event with prior coordination and approval by the Coast Guard Captain of the Port, or designated representative. Furthermore, the annual events occur during times of the year when commercial vessel traffic is normally low. Moreover, The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the regulation.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received zero comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit through the regulated area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary and limited safety zone in Pago Pago Harbor. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of Commandant Instruction M16475.lD. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

On March 27, 2013, the State of Delaware through the Delaware Department of Natural Resources and Environmental Control (DNREC) submitted a revision to its SIP to satisfy the requirements of section 110(a)(2), including 110(a)(2)(D)(i), of the CAA as it relates to the 2008 ozone NAAQS.

On March 12, 2008, EPA revised the levels of the primary and secondary ozone standards from 0.08 parts per million (ppm) to 0.075 ppm (73 FR 16436). The CAA requires states to submit, within three years after promulgation of a new or revised NAAQS, SIP revisions meeting the applicable elements of sections 110(a)(1) and (2).1 Several of these applicable elements are delineated within section 110(a)(2)(D)(i) of the CAA. Section 110(a)(2)(D)(i) generally requires SIPs to contain adequate provisions to prohibit in-state emissions activities from having certain adverse air quality effects on neighboring states due to interstate transport of air pollution. There are four prongs within section 110(a)(2)(D)(i) of the CAA; section 110(a)(2)(D)(i)(I) contains prongs 1 and 2, while section 110(a)(2)(D)(i)(II) includes prongs 3 and 4. This direct final action addresses the first two prongs, which are also collectively known as the good neighbor provision. According to the CAA's good neighbor provision located within section 110(a)(2)(D)(i)(I), a state's SIP must contain adequate provisions to prohibit any source or other type of emissions activity within the state from emitting air pollutants that “contribute significantly to nonattainment in, or interfere with maintenance by, any other state with respect to any such national primary or secondary ambient air quality standard.” Under section 110(a)(2)(D)(i)(I) of the CAA, EPA gives independent significance to the matter of nonattainment (prong 1) and to that of maintenance (prong 2).

On March 27, 2013, the State of Delaware through DNREC provided a SIP revision submittal to satisfy the requirements of section 110(a)(2) of the CAA for the 2008 ozone NAAQS. In this rulemaking action, EPA is approving one portion of Delaware's March 27, 2013 submittal—the portion addressing prongs 1 and 2 of section 110(a)(2)(D)(i)(I) of the CAA. EPA previously acted on other portions of Delaware's March 27, 2013 SIP submittal for the 2008 ozone NAAQS.2

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0878 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 27, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0878, by one of the following methods:

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

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

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

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

In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8328) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide fluazifop-p-butyl in or on the raw agricultural commodities lettuce, head and leaf at 5.0 parts per million (ppm); strawberry at 3.0 ppm; onion, green at 1.5 ppm; caneberry subgroup 13-07A at 0.05 ppm; bushberry subgroup 13-07B at 0.3 ppm; tuberous and corm vegetables (except for potato) subgroup 1D at 1.5 ppm; small fruit vine climbing, except for fuzzy kiwifruit subgroup 13-07F at 0.03 ppm; and onion, bulb subgroup 3-07A at 0.5 ppm as well as tolerances with regional registration for grass hay at 15 ppm; and grass forage at 4.0 ppm. Upon the approval of the aforementioned tolerances, IR-4 requested removal of the existing tolerances for grape at 0.01 ppm; onion, bulb at 0.5 ppm; and sweet potato, roots at 0.05 ppm; and also requested amend the existing tolerance for rhubarb from 0.5 ppm to 0.4 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has modified the levels at which tolerances are being established for some commodities. The reasons for these changes are explained in Unit IV.C.

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

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

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

The toxicity profile shows that the principal toxic effects of fluazifop-P-butyl are changes in the liver and kidney following exposure via the oral route. Liver toxicity is observed in rats, hamster, and dogs, while kidney toxicity is observed in rats.

Other adversely effected organs included the testes and eyes in rats and hamsters. Adrenal fatty vacuolation and increased incidence of thymic involution were noted in the chronic dog study. Gall bladder stones and ovarian cell hyperplasia were noted in the carcinogenicity study in hamsters. From the toxicity studies, the lowest LOAELs were observed in long-term studies, suggesting progression of toxicity with duration of treatment.

Quantitative sensitivity of the fetus was observed in the rat developmental studies in which no maternal toxicity was observed. Developmental toxicity in the rat was generally related to incomplete ossification. At higher doses, decreased fetal body weight and an increased incidence of diaphragmatic hernia were observed. In the rabbit, maternal and developmental toxicity were observed at the same dose. Maternal toxicity included abortions, weight loss, and death, and fetal toxicity included abortions, skeletal effects, and fetuses that were small and/or had cloudy eyes. In the rat reproduction and fertility study, maternal (increased liver weight, bile duct hyperplasia, geriatric nephropathy) and offspring (decreased pup viability, decreased pup body weight, and hydronephrosis) toxicity were observed at the same dose level, and decreased female fertility was observed at the highest dose.

No immunotoxicity was observed at the highest dose tested in the immunotoxicity study in rats. Although other studies indicated effects on the immune system organs (e.g., thymus effects in the dog), all points of departure (PODs) are protective of any possible immunotoxic response. Delayed neurotoxicity was not observed in hens, and there was no evidence of toxicity in the subchronic neurotoxicity study. In the acute neurotoxicity study at the lowest dose tested (500 milligrams/kilogram (mg/kg)), where a bolus dose is administered by gavage, clinical signs indicative of toxicity (reduced activity, decreased rearing, hunched posture, and/or piloerection) were observed, as well as decreased motor activity (total distance and number of rearings) in both sexes. There was no evidence of carcinogenicity or mutagenicity in the toxicity profile.

Specific information on the studies received and the nature of the adverse effects caused by fluazifop-P-butyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document title “Fluazifop-P-butyl. Human-Health Risk Assessment for New Uses on Lettuce (Leaf and Head), Rhubarb, Green Onion, Strawberry, Caneberry Subgroup 13-07A, Bushberry Subgroup 13-07B, Fescue Grasses (Grown for Seed); and for Amendments to Existing Tolerances [Subgroups 1D, 3-07A, and 13-07F]” on page 42 in docket ID number EPA-HQ-OPP-2014-0878.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD)s and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for fluazifop-P-butyl used for human risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluazifop-P-butyl, EPA considered exposure under the petitioned-for tolerances as well as all existing fluazifop-P-butyl tolerances in 40 CFR 180.411. EPA assessed dietary exposures from fluazifop-P-butyl in food as follows:

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

Such effects were identified for fluazifop-P-butyl. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance level residues with a ratio adjustment for additional metabolites of concern.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, the Agency used mean residue levels from crop field trials with a ratio adjustment for additional metabolites of concern, average percent crop treated estimates, and experimentally determined processing factors.

iii. Cancer. EPA has concluded that fluazifop-P-butyl does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

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

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

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

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency estimated the average PCT for existing uses as follows:

Asparagus, 2.5%; carrots, 15%; cotton, 1%; dry beans/peas, 1%; garlic, 10%; grapefruit, 15%; grapes, 2.5%; nectarines, 1%; onions, 10%; oranges, 2.5%; peaches, 2.5%; peanuts, 1%; plums, 2.5%; potatoes, 1%, prunes, 2.5%; soybeans, 2.5%; and sugar beets, 1%.

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

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

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fluazifop-P-butyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluazifop-P-butyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Surface Water Concentration Calculator (SWCC) model and the Pesticide Root Zone Model Ground Water (PRZM-GW) model, the estimated drinking water concentrations (EDWCs) of fluazifop-P-butyl for acute exposures are estimated to be 56.6 parts per billion (ppb) for surface water and 6.8 ppb for ground water and for chronic exposures are estimated to be 4.41 ppb for surface water and 3.39 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 56.6 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 4.41 ppb was used to assess the contribution to drinking water.

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

Fluazifop-P-butyl is currently registered for the following uses that could result in residential exposures: Lawns/turf and ornamentals. EPA assessed residential exposure using the following assumptions: For handlers, exposure is expected as a result of application to turf and ornamentals. Post-application exposure is also expected as a result of being in an environment that has been previously treated with fluazifop-P-butyl.

For adult handlers, risk estimates are presented as an aggregated risk index (ARI) since the PODs for dermal and inhalation routes of exposure are based on the same study/effects, but have different LOCs (dermal LOC = 100 and inhalation LOC = 1000). The target ARI is 1; ARIs of less than 1 are risk estimates of concern. None of the residential handler scenarios resulted in a risk estimate of concern (i.e., all ARIs ≥1).

For post-application, only dermal and incidental oral (for kids only) exposures were assessed. Since the PODs for these routes are based on the same effects and have the same LOC, risk estimates can be combined. All residential post-application MOEs are greater than the LOC of 100, and are therefore not of concern.

The Agency used the worst-case exposure scenarios for all population subgroups for recommendation for inclusion in the aggregate assessment. The residential exposure scenario used in the adult aggregate assessment is dermal and inhalation handler exposure from applications to gardens/trees using a backpack sprayer. The residential exposure scenario used in the youth (11 to <16 years) aggregate assessment is dermal post-application exposure from golfing on treated turf. The residential exposure scenario used in the child (6 to <11 years) aggregate assessment is dermal post-application exposure from activities in treated gardens. The residential exposure scenario used in the child (1 to <2 years) aggregate assessment reflects combined dermal plus hand-to-mouth post-application exposure from high contact activities on treated turf. The PODs for the adult dermal and inhalation routes of exposure are based on the same study and based on the same effects; however, the LOCs are different (dermal LOC = 100 and inhalation LOC = 1000). Therefore, a total aggregated risk index (ARI) was used to combine risk estimates. The aggregate risk index (ARI) is calculated as follows:

Aggregate Risk Index (ARI) = 1 ÷ [(Dermal LOC ÷ Dermal MOE) + (Inhalation LOC ÷ Inhalation MOE)]. The target ARI is 1; ARIs of less than 1 are risk estimates of concern. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

EPA has not found fluazifop-P-butyl to share a common mechanism of toxicity with any other substances, and fluazifop-P-butyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluazifop-P-butyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. Quantitative sensitivity of the fetus was observed in the rat developmental studies in which no maternal toxicity was observed. Developmental toxicity in the rat was generally related to incomplete ossification. At higher doses, decreased fetal body weight and an increased incidence of diaphragmatic hernia were observed. In the rabbit, maternal and developmental toxicity were observed at the same dose. Maternal toxicity included abortions, weight loss, and death, and fetal toxicity included abortions, skeletal effects, and fetuses that were small and/or had cloudy eyes. In the rat reproduction and fertility study, maternal (increased liver weight, bile duct hyperplasia, geriatric nephropathy) and offspring (decreased pup viability, decreased pup body weight, and hydronephrosis) toxicity were observed at the same dose level, and decreased female fertility was observed at the highest dose.

3. Conclusion. For acute dietary and inhalation short-term exposure scenarios, the Agency is retaining the FQPA safety factor of 10x for the use of a LOAEL to extrapolate a NOAEL (acute dietary) and to account for the lack of a subchronic inhalation toxicity study (inhalation short-term). EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x for the chronic dietary, incidental oral, and dermal short-term exposure scenarios. That decision is based on the following findings:

i. The toxicity database for fluazifop-P-butyl for assessing these scenarios is complete.

ii. Possible signs of neurotoxicity were observed at 500 mg/kg in the acute neurotoxicity study. The clinical signs observed included reduced activity, decreased rearing, hunched posture and/or piloerection, and decreased motor activity (total distance and number of rearings) in both sexes. However, considering that this was a bolus (gavage) dose at half the limit dose, the nature of the observations and the lack of neuropathology suggests that the findings were a result of generalized toxicity rather than neurotoxicity.

Slight increases in absolute (2.5%) and relative (1.6%) brain weights were seen in both sexes at 3,000 ppm (≉194 mg/kg/day) at termination in the carcinogenicity study in hamsters. Slight increases in brain weights were seen in female rats (2.9%) at 100 mg/kg/day and in male hamsters (4%) at 120 mg/kg/day after subchronic exposures with fluazifop-P-butyl. The toxicological significance of the marginal increases in brain weights at high doses is unknown in the absence of corroborative histopathological lesions.

The Agency concluded that there was not a concern for neurotoxicity resulting from exposure to fluazifop-P-butyl at relevant exposure levels. The only indication of potential neurotoxicity was due to a large (500 mg/kg) bolus dose (gavage) in the acute neurotoxicity study. No developmental or central nervous system malformations were seen in any of the developmental toxicity studies with rats or rabbits. No increased offspring sensitivity over parent was seen in the rabbit pre-natal developmental studies or in the rat post-natal reproduction study, and no evidence of neurotoxicity or neuropathology was observed in adult animals. Although malformed fetuses were seen at high dose levels in the absence of maternal toxicity in the rat developmental toxicity studies, the definitive developmental endpoint in five developmental studies was selected based on delayed ossification and fetal weight decrement at much lower doses (100-fold lower). Therefore, the conditions were not met for requiring a developmental neurotoxicity study.

iii. There was no indication of fetal or offspring susceptibility in rabbit developmental or rat reproduction studies. Quantitative sensitivity of the fetus was noted in the rat developmental studies as described above. However, the selected PODs are protective for all exposure scenarios where the developing fetus is of concern. Therefore, the degree of concern is low.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments include assumptions that result in high-end estimates of dietary food exposure. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluazifop-P-butyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluazifop-P-butyl.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluazifop-P-butyl will occupy 42% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluazifop-P-butyl from food and water will utilize 49% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluazifop-P-butyl is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Fluazifop-P-butyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to fluazifop-P-butyl.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate ARIs of 2.1 for adults, 51 for youths 11-16 years old, 13 for children 6-11 years old, and 1.7 for children 1-2 years old. Because EPA's level of concern for fluazifop-P-butyl is an ARI of 1 or below, these ARIs are not of concern.

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

Intermediate-term adverse effects were identified; however, fluazifop-P-butyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for fluazifop-P-butyl.

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

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

Adequate enforcement methodology (High Performance Liquid Chromatography/Ultra-Violet Spectrometry (HPLC/UV)) is available to enforce the tolerance expression.

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

The Codex has not established any MRLs for fluazifop-P-butyl.

The petitioner requested a tolerance of 5.0 ppm for “Lettuce, head and leaf”. This is not a standard commodity definition. Rather, the Agency is establishing separate tolerances for “Lettuce, head” and “Lettuce, leaf” at 3.0 and 5.0 ppm, respectively, as determined by the Organization for Economic Cooperation and Development (OECD) MRL calculation procedures. The caneberry subgroup 13-07A tolerance is being established at 0.08 ppm instead of 0.05 ppm as requested since two of the raspberry trials were determined not to be independent. The requested tolerances for grass forage and hay is being established as fescue forage and hay because the use requested for the corresponding pesticide registration is limited to fescue grass varieties. In addition, where appropriate, EPA has modified the numerical expression of tolerance values in order to conform to current Agency policy on significant figures.

Therefore, tolerances are established for residues of fluazifop-P-butyl, butyl (2R)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, including its metabolites and degradates, in or on the bushberry subgroup 13-07B at 0.30 ppm; caneberry subgroup 13-07A at 0.08 ppm; fescue, forage at 4.0 ppm (tolerance with regional registrations); fescue, hay at 15 ppm (tolerance with regional registrations); fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.03 ppm; lettuce, head at 3.0 ppm; lettuce, leaf at 5.0 ppm; onion, bulb, subgroup 3-07A at 0.50 ppm; onion, green at 1.5 ppm; strawberry at 3.0 ppm; and vegetable, tuberous and corm, except potato, subgroup 1D at 1.5 ppm.

Additionally, the existing tolerances for grape; onion, bulb; and sweet potato, roots are removed as unnecessary, since they are covered by the newly established crop group tolerances, and the tolerance with regional registrations for rhubarb at 0.5 ppm, currently under section 180.411(c), will now be listed in section 180.411(a) since it will now have a national registration.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0049 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 27, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0049, by one of the following methods:

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

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

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

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

In the Federal Register of Tuesday, December 20, 2016 (81 FR 92758) (FRL-9956-04), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP# 6E8505) by Interregional Research Project Number 4 (IR-4). The petition requested that 40 CFR 180.685 be amended by establishing tolerances for residues of the fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on cacao bean, bean at 0.10 parts per million (ppm); cacao bean, roasted bean at 0.15 ppm; cacao bean, chocolate at 0.15 ppm; and cacao bean, cocoa powder at 0.15 ppm. A summary of the petition prepared by IR-4 is available in the docket, http://www.regulations.gov. There were no comments received on the notice of filing.

Based upon review of the data supporting the petition, EPA is establishing tolerances that differ from what the petitioner requested including; the commodity definition, tolerance level, and for which commodities. The reasons for these changes are explained in Unit IV.C.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for oxathiapiprolin including exposure resulting from the tolerance established by this action, consistent with FFDCA section 408(b)(2).

In the Federal Register of Monday, December 5, 2016 (81 FR 87463) (FRL-9954-69), EPA established tolerances for residues of oxathiapiprolin in or on several food commodities. The risk assessments supporting that action aggregated dietary and non-occupational exposures from existing and proposed uses of oxathiapiprolin, including from the exposures associated with the tolerances requested in this action. That assessment, which included the tolerances in today's action, concluded that the tolerances are safe; therefore, EPA is incorporating the findings in that Federal Register document and the supporting risk assessments as the basis for the safety finding in this tolerance rulemaking. In brief, the Agency determined that the lack of toxicity of oxathiapiprolin warranted a qualitative risk assessment, without the need for the additional Food Quality Protection Act safety factor to protect infants and children.

Specific information on the studies received and the nature of the adverse effects caused by oxathiapiprolin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, “Oxathiapiprolin—New Active Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals, and a Number of Crops” dated June 25, 2015, in docket ID number EPA-HQ-OPP-2016-0049-0018. In addition, an abbreviated human health risk assessment document was developed to support the proposed uses of oxathiapiprolin on multiple crops, including cacao. That document, “SUBJECT: Oxathiapiprolin. Human Health Risk Assessment to Support the Registration of New Uses of the Fungicide on Various Crops” dated October 31, 2016 is available in docket ID number EPA-HQ-OPP-2016-0049-0017.

In conclusion, based on the findings of the December 5, 2016 Federal Register document and the supporting documents, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to oxathiapiprolin residues.

Method 30422 (Supplement No. 1) was developed for plant commodities, and Method 31138 was developed for livestock commodities. Residues of oxathiapiprolin and associated metabolites are extracted from crop or livestock commodity samples using a solution of formic acid, water and acetonitrile, and diluted with acetonitrile and water. Both methods use liquid chromotography with tandem mass spectrometry (LC/MS/MS), specifically reverse-phase liquid chromatography (LC), and detection by electrospray tandem mass spectrometry (MS/MS).

The FDA multi-residue methods are not suitable for detection and enforcement of oxathiapiprolin residues or associated metabolites. However, the European Multiresidue Method (DFG Method S19) and the QuEChERS Multiresidue Method have shown success in some matrices.

Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch/BEAD/OPP, Environmental Science Center, 701 Mapes Rd., Ft. George G. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has not established maximum residue limits (MRLs) for oxathiapiprolin.

A tolerance is established for “Cacao bean, dried bean”, rather than “Cacao bean, bean”, to comply with current Agency crop-naming policy. Also, EPA determined that tolerances for residues of oxathiapiprolin in or on the processed commodities of cacao bean, roasted bean; cacao bean, chocolate; and cacao bean, cocoa powder are unnecessary because these commodities are covered by cacao bean, dried bean tolerance. Finally, the tolerance for cacao bean, dried bean is being established at 0.15 ppm, rather than at 0.1 ppm as requested, based on the available residue data.

Therefore, a tolerance is established for residues of the fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on cacao bean, dried bean at 0.15 ppm.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

Table of Contents I. Executive Summary a. Overview b. Summary of the Final Rule and Highlighted Differences With the NPRM 1. Every Day (Normal) Vehicle Operations i. Direct Contact Protection From High Voltage Sources ii. Indirect Contact Protection From High Voltage Sources iii. Electrical Isolation of High Voltage Sources iv. Monitoring Systems v. Electrical Safety During Charging vi. Mitigating Driver Error 2. Post-Crash Safety i. Direct and Indirect Contact Protection From High Voltage Sources ii. Electrical Isolation 3. Definitions, Figures, and Test Procedures 4. Compliance Date II. Background a. Overview of the GTR Process b. Overview of GTR No. 13 c. Physical Barrier Option d. Petitions for Rulemaking III. Overview of the Comments IV. Response to the Comments a. Definitions and Terminology (General) b. Clarification of Application of Requirements c. Electrical Safety for Connectors and the Vehicle Charge Inlet d. Markings e. Indirect Contact Protection f. Electrical Isolation Requirements g. Electrical Safety During Charging h. Mitigating Driver Error i. Test Procedures and Figures in FMVSS No. 305 j. Compliance Date V. Rulemaking Analyses and Notices I. Executive Summary a. Overview

NHTSA is issuing this final rule to update FMVSS No. 305, “Electric-powered vehicles: Electrolyte spillage and electrical shock protection.” As indicated in its title, one purpose of FMVSS No. 305 is to reduce deaths and injuries from electrical shock. Currently, the standard focuses on post-crash safety, requiring vehicles with high voltage sources to protect vehicle occupants, rescue workers and others who may contact the vehicle after a crash. To protect against electric shock, FMVSS No. 305 currently 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 1 or (b) their voltage must be at levels considered safe from harmful electric shock.2 This final rule amends the standard to adopt a physical barrier compliance option that prevents direct and indirect contact 3 of high voltage sources post-crash by way of “electrical protection barriers.” An electrical protection barrier is a physical barrier that encloses a high voltage source to prevent direct contact (by occupants, emergency services personnel and others) of the high voltage source from any direction of access.

This final rule is a deregulatory action as it imposes no costs and adjusts FMVSS No. 305 to give more flexibility to manufacturers not only for current electric vehicle designs, but also for introducing new technologies to the U.S. market, including hydrogen fuel cell vehicles (HFCVs) and 48-volt mild hybrid technologies. In adopting the physical barrier option, this final rule adjusts the standard to remove an obstruction that prevented HFCVs from being offered for sale in the U.S. Adopting the physical barrier option also enables manufacturers to produce 48-volt mild hybrid systems without having to use electrical isolation safety measures that involve more complexity, higher consumer costs, and higher mass, without an incremental safety benefit. This rule responds to petitions for rulemaking from Toyota Motor North America Inc. (Toyota) 4 and the Auto Alliance (Alliance).5

NHTSA is also issuing this final rule as part of the agency's ongoing effort to avoid unnecessary differences in the vehicle safety standards of different countries through a harmonization process under the United Nation Economic Commission for Europe (UNECE) 1998 Global Agreement (“1998 Agreement”). The efforts of the U.S.6 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. 13.7 This final rule adopts requirements based on the electrical safety requirements of GTR No. 13.8

Similar to FMVSS No. 305, GTR No. 13 has requirements intended to reduce deaths and injuries from electrical shock, but addresses both normal vehicle operation and post-crash safety. Also, while the various post-crash compliance options in GTR No. 13 are like those in FMVSS No. 305, GTR No. 13 includes the physical barrier option to prevent direct and indirect contact 9 of high voltage sources.

On March 10, 2016, NHTSA issued the notice of proposed rulemaking (NPRM) on which this final rule is based (81 FR 12647). The NPRM proposed adopting GTR No. 13's normal vehicle operation requirements, and proposed adopting a post-crash physical barrier compliance option like that in GTR No. 13.

Comments on the NPRM were generally supportive of the proposed changes. Some commenters requested modifying the proposed regulatory text to clarify the wording of requirements and test procedures or to align the text with GTR No. 13 and ECE R.100, “Uniform provisions concerning the approval of vehicles with regard to specific requirements for the electric power train,” and some suggested NHTSA should not adopt some requirements for lack of safety need.

This final rule adopts most aspects of the proposal, with some parts changed in response to commenters. The final rule improves motor vehicle safety by expanding FMVSS No. 305's protections to normal vehicle operations. The updated post-crash performance requirements ensure that new power train configurations provide a comparable level of post-crash safety as that of existing electric vehicles.

This final rule reflects the state-of-the art in vehicle electrical safety. It draws from the findings from the agency's research on the physical barrier compliance option in GTR No. 13 (Battelle study),10 ECE R.100, and the electrical safety requirements in a January 2014 version of SAE J1766.11

The rule not only gives more flexibility to manufacturers to use modern electrical safety designs to produce electric vehicles and introduce new vehicle technologies, but also paves the way globally for future innovations on vehicle electrical safety. A new GTR is under development 12 for electric vehicle safety (EVS-GTR) which includes specifications for high voltage electrical components and rechargeable electric energy storage systems. In November 2016, NHTSA and other parties developing the new draft GTR completed the document's high voltage electrical safety provisions. The parties designed the draft GTR to reflect the provisions of GTR No. 13, ECE R.100, and the requirements proposed in the March 2016 NPRM and adopted by this final rule.

We estimate that the final rule will result in essentially no cost to consumers in the U.S. This rule adopts requirements that closely mirror the electrical safety provisions of GTR No. 13, which have already been implemented by manufacturers in this country.

This section summarizes the requirements adopted by this final rule. For the convenience of the reader, we also note the few notable differences between this rule and the NPRM. The reasons underlying our decisions are explained in the body of this preamble and in the NPRM.

This final rule adds electrical safety requirements for vehicle performance during every day (normal) vehicle operations to mitigate the risk of electric shock due to direct or indirect contact of high voltage sources or loss in electrical isolation. We also adopt requirements to assure electrical safety during refueling and to mitigate driver error in vehicle operation.

The rule specifies:

A. IPXXD protection degree for high voltage sources inside passenger and luggage compartments, and IPXXB protection degree for high voltage sources outside passenger and luggage compartments.13

B. IPXXB protection degree for service disconnects that can be opened or removed without tools.14

C. Markings on certain electrical protection barriers of high voltage sources (i.e., barriers that can be physically accessed, opened, or removed without the use of tools) and on or near electric energy storage devices. As to the latter, the NPRM also proposed to require markings on or near electric energy conversion devices (fuel cells), but the agency concludes conversion devices are benign in and of themselves in that they are not high density energy sources. Thus, conversion devices do not need to be marked. (Note that the electric protection barrier around a fuel cell is required to be marked.) In another change from the NPRM, markings are not required on electrical connectors and on the vehicle charge inlet 15 because of a lack of a need for the markings.

D. In a change from the NPRM, this rule has distinct direct contact protection requirements for connectors and the vehicle charge inlet. First, it requires that the IPXXB/IPXXD protection levels be met by each connector when connected to its mating component. IPXXD protection degree is required for connectors located inside the passenger and luggage compartments. IPXXB protection degree is required for connectors and vehicle charge inlets located outside these compartments. Second, connectors must meet at least one of the following three requirements: (1) If a connector or vehicle charge inlet can be separated from its mating component without the use of tools, the IPXXB/IPXXD protection level must be provided when the connector is uncoupled from its mating component; (2) if a connector or vehicle charge inlet can be separated from its mating component without the use of tools, the voltage of live parts of the connector or vehicle charge inlet becomes less than or equal to 60 VDC or 30 VAC within one second of separating from its mating component; or, (3) the connector has a locking mechanism (at least two distinct actions are needed to separate the connector from its mating component), and there are other components that must be removed to separate the connector from its mating component and these cannot be removed without the use of tools.

E. This rule requires orange color outer coverings for cables of high voltage sources that are located outside electrical protection barriers.

This rule requires exposed conductive parts of electrical protection barriers to be conductively connected to the chassis with a resistance less than 0.1 ohms, and the resistance between two simultaneously reachable exposed conductive parts of electrical protection barriers that are within 2.5 meters of each other must be less than 0.2 ohms.16

A. This rule requires 500 ohms/volt or higher electrical isolation for AC high voltage sources and 100 ohms/volt or higher for DC high voltage sources.

B. Where AC and DC buses are connected, this rule permits AC high voltage sources to have electrical isolation of 100 ohms/volt or higher, provided they also have the direct and indirect contact protection described in i and ii, above.

This rule requires an electrical isolation monitoring system for DC high voltage sources on fuel cell vehicles.

This final rule requires:

A. Electrical isolation greater than or equal to 500 ohms/volt between the electrical chassis and other high voltage sources connected to the vehicle charge inlet (for connecting to the AC external power supply). Note that this is a change from the 1 million ohms isolation resistance requirement proposed in the NPRM.

B. IPXXB/IPXXD protection level for the vehicle charge inlet when connected to the charge connector and IPXXB/IPXXD protection level or low voltage when separated from the charge connector.

C. Conductive connection of the electric chassis to earth ground before and during the application of exterior voltage to the vehicle.17

This final rule includes requirements for—

A. Providing at least a momentary indication to the driver when the vehicle is first placed in “possible active driving mode” after manual activation of the propulsion system.18 This is a change from the NPRM to clarify when the momentary indication must be provided.

B. Informing the driver if the vehicle is still in a possible active driving mode,19 by an audible or visual signal when he or she leaves the vehicle; and,

C. Preventing vehicle movement of more than 150 millimeters (mm) by its own propulsion system when the vehicle charging system is connected to the external electric power supply in such a way that charging is possible. (The 150 mm limit is a change from the NPRM, which did not specify a distance.)

This final rule also amends FMVSS No. 305's post-crash electrical safety requirements.

The rule adds an optional method of meeting post-crash electrical safety requirements through physical barrier protection of high voltage sources. The specifications of this optional method of electric safety include requirements ensuring that:

A. High voltage sources are enclosed in barriers that prevent direct human contact with high voltage sources (IPXXB protection level),

B. Exposed conductive parts of electrical protection barriers are conductively connected to the chassis with a resistance less than 0.1 ohms. The resistance between any two simultaneously reachable exposed conductive parts of electrical protection barriers that are less than 2.5 meters from each other must be less than 0.2 ohms.

C. Voltage between exposed conductive parts of an electrical protection barrier and the electrical chassis, and between two simultaneously reachable exposed conductive parts of the electrical protection barrier that are less than 2.5 meters from each other, must be less than or equal to 60 VDC or 30 VAC (low voltage). (The NPRM was worded to apply this requirement to voltage between any exposed conductive parts of the vehicle.)

An AC high voltage source that is conductively connected to a DC high voltage source may meet an electrical isolation requirement of 100 ohms/volt or greater, provided the AC high voltage source also has physical barrier protection specified in i(A) and i(B), above.20 (The NPRM had proposed requiring all three elements i(A), i(B), and i(C) of physical barrier protection for such AC high voltage sources.)

We make minor changes to a number of proposed definitions to clarify the standard and to achieve consistency with other definitions. We adopt terms such as “high voltage live parts,” “exposed conductive parts of electrical protection barriers,” and “possible active driving mode” in place of proposed terms that were less clear.

We make a minor correction to Figure 7b and clarify Figure 8.

We clarify several test procedures, including how we will use the IPXXB and IPXXD protection degree probes and how we determine the voltage between various conductive parts. We provide manufacturers the option of choosing between two methods for measuring resistance, and, in a change from the NPRM, provide that resistance between two exposed conductive parts of the electrical protection barrier may be computed from measured resistances.

The compliance date for this final rule is one year from the date of publication of the final rule in the Federal Register. Optional early compliance is permitted. (The NPRM proposed a compliance date of 180 days after the publication of the final rule in the Federal Register.)

The United States is a contracting party to the 1998 Agreement, which was entered into force in 2000 and is administered by the UN ECE's Working Party (WP).29. The purpose of this agreement is to establish GTRs.

GTR No. 13 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 establishes 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.21 By issuance of the March 10, 2016 NPRM preceding this final rule, NHTSA initiated the process for considering adoption of GTR No. 13.

This final rule addresses the electrical safety requirements in GTR No. 13 (i.e., the electrical isolation requirements, physical barrier requirements, etc.) and not GTR No. 13's hydrogen fuel system and fuel container integrity requirements. NHTSA will commence a separate proceeding on incorporating the latter portions of GTR No. 13 into the relevant FMVSSs.

HFCVs 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 like that of electric and hybrid electric vehicles.

GTR No. 13 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. 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.” 22

The industry has long requested NHTSA to adopt a physical barrier option into FMVSS No. 305. In 2010, NHTSA decided against adoption of a physical barrier option because the agency believed not enough was known about the option.23 Commenters to an NPRM to upgrade FMVSS No. 305's electrical shock protection requirements had asked NHTSA to adopt the option in the final rule. NHTSA declined the request,24 explaining that (a) sufficient notice might not have been provided for the provision, (b) the agency was uncertain whether the option would sufficiently account for indirect contact failure modes, and (c) the agency wished to pursue research on this safety approach. NHTSA undertook a research program (later known as the Battelle study, discussed in detail in the NPRM, 81 FR at 12656-12659) to better understand the issues related to a physical barrier option for electrical safety.

Since that decision in 2010, several milestones ensued. 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 International revising SAE J1766 in January 2014 to set forth more protective safety practices than it had before. 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.

This final rule responds not only to GTR No. 13 but also to petitions for rulemaking from Toyota and the Alliance. The petitions are discussed in detail in the March 10, 2016 NPRM. See 81 FR at 12659-12663.

Petitioner Toyota believes that an additional compliance option that includes elements of the physical barrier option in GTR No. 13 is needed to allow HFCVs to be offered for sale in the U.S.

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 current 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 electrical isolation for fuel cell stacks would need to be 500 ohms/volt or greater to comply with FMVSS No. 305, which may not be technically feasible. 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 SAE J1766 January 2014,25 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 Alliance 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 consequences are inappropriate when there would be no incremental safety benefit gained beyond that associated with SAE J1766's physical barrier option.

NHTSA received six comments on the NPRM. Comments were received from two motor vehicle manufacturer associations (the Alliance and the Association of Global Automakers (Global)), three vehicle manufacturers (Mercedes-Benz USA LLC (Mercedes-Benz), Tesla Motors Inc. (Tesla), and Fuji Heavy Industries on behalf of Subaru of America Inc. (Subaru)), and one individual.

The commenters strongly support that FMVSS No. 305 should include requirements for normal vehicle operation and incorporate a physical barrier option for electrical safety. They request changes to the proposed regulatory text to improve clarity of or correct wording and to align the regulatory language, including definitions, to that in GTR No. 13 and ECE R.100. Some commenters suggest NHTSA not adopt or reduce the stringency of particular requirements for lack of safety need, such as the marking of connectors and the vehicle charge inlet, and a “one million ohms” isolation requirement for charging electrical energy storage devices. Several commenters suggest NHTSA adopt separate performance requirements for connectors and for the vehicle inlet, that include direct contact protection when connected and separated from its mating component. Some commenters request NHTSA change how the agency will conduct compliance tests, such as by limiting the number of resistance and voltage measurements between exposed conductive parts. Several commenters request the compliance date for the amendments be longer than 180 days.

Commenters request modifications to certain definitions and terms generally used in the regulatory text. The Alliance believes that the definition of “exposed conductive part” should be revised to clarify that the part is not normally energized (that energization can occur under a fault condition). The Alliance also requests replacing the term, “exposed conductive parts” in the regulatory text with “exposed conductive parts of electrical protection barriers,” so as to exclude conductive parts that are not part of the electrical protection barriers and the electric power train, such as hose clamps. Similarly, Global suggests the term be replaced with “exposed conductive part of the electrical protection barrier enclosing the high voltage source,” throughout the regulatory text. Commenters suggest “electrical barriers,” should be replaced with “electrical protection barriers,” in the regulatory text for consistency and to reduce ambiguity. The Alliance requests a broadened definition for “external electric power supply,” to refer to “electric energy storage device,” in part because the proposed definition uses the term “propulsion battery,” which is not defined. The Alliance requests replacing the term, “live parts” with “high voltage live parts” in the regulatory text since electrical safety requirements apply to high voltage sources.

NHTSA reviewed these comments and generally agrees with revising the definitions and terms at issue, to clarify the text of FMVSS No. 305. We summarized our decisions in Table 1 and have incorporated appropriate changes into the regulatory text.

The Alliance asks that we amend the definition of “high voltage source” to make clear that a component is a high voltage source based on its working voltage. The current definition states: “High voltage source means any electric component contained in the electric power train or conductively connected to the electric power train that has a working voltage greater than 30 VAC or 60 VDC.” The commenter states that the definition can be read in two different ways because “it is not clear if the component or the electric power train is being modified by the given voltage limits.” (Emphasis in text.) NHTSA's intent was to modify the “component.” 26 We have clarified the definition in the regulatory text.

The Alliance and Global point out that the definition of luggage compartment mistakenly refers to “protecting the power train” instead of “protecting the occupant.” We note that the definition's reference to “hood” should also refer to “trunk lid,” as in the U.S. luggage compartments are usually thought of as trunks, which are thought to have “trunk lids.” We have made the corrections in the text.

The Alliance requests adding a definition for the term “connector,” assuming NHTSA will adopt separate electrical safety requirements for connectors (this issue is discussed in a section below). The Alliance states that a connector is a device that provides mechanical connection and disconnection of high voltage electrical conductors to a suitable mating component, including its housing. Since this final rule adopts such separate requirements for connectors, the agency agrees to add a definition for “connector” to the regulatory text.

The Alliance states that “electric energy storage device” in proposed S5.4.3.2 is too specific and thereby restrictive, and that “electric circuit” should be used instead. We concur the proposed term is overly specific, but since “electric circuit” is not used or defined in FMVSS No. 305, we will use “electric component” in place of the term at issue.27

Subaru requests clarification of the meaning of the term “normal vehicle operation.” Subaru asks whether the term refers to anytime the vehicle is being driven under its own power or to any vehicle operation when no system faults or abnormalities are present. Subaru asks whether the reference to normal vehicle operation in the definition of the term, “live parts,” 28 includes the vehicle's driving under its own electric power and static charging modes.

NHTSA believes that “normal vehicle operation” includes operating modes and conditions that can reasonably be encountered during typical operation of the vehicle, such as driving, parking and standing in traffic, as well as, charging using chargers that are compatible with the specific charging ports installed on the vehicle. It does not include conditions where the vehicle is damaged, either by a crash or road debris, subjected to fire or water submersion, or in a state where service and or maintenance is needed or being performed.

The Alliance, Global and Subaru ask about adding a definition for an “enclosure,” since in the NPRM the agency used the term “enclosure” as though an enclosure was distinct from an electrical protection barrier. We meant the terms to be synonymous. However, rather than add the definition, for simplicity we have removed the term “enclosure” from the standard and only use the term “electrical protection barrier.”

For the convenience of the reader, Table 1 below shows the notable added and revised terms.

The Alliance requests we add paragraphs to the regulatory text explicitly stating that the electrical safety requirements (S5.3) and the monitoring system requirement (S5.4) of FMVSS No. 305 do not apply to the DC part of a 48-volt mild hybrid system. (This pertains to the DC part that is conductively connected to the electrical chassis and that has a working voltage less than or equal to 60 VDC, and the maximum voltage between the DC live part and any other live part is less than or equal to 30 VAC or 60 VDC.) The commenter states that the draft EVS-GTR includes such a statement.

We do not believe there is a need for such a provision in FMVSS No. 305, for several reasons.

First, as discussed in a previous section, we are amending the definition of “high voltage source,” as the Alliance requests, to make clear that a component is a high voltage source based on its working voltage. That change provides the clarification the commenter seeks.

Second, the Alliance asks that NHTSA provide in the preamble the following statement for further clarification. The commenter's statement is: “Where electrical circuits, that are galvanically connected to each other, and fulfilling the condition, that the maximum voltage between a DC live part and any other live part (DC or AC) is less [than] or equal [to] 30 VAC and 60 VDC, only the components or parts of the electric circuit that operate on high voltage are classified as high voltage sources.” We concur that the statement is consistent with NHTSA's intent.

Third, the agency does not believe the above-quoted text is needed in FMVSS No. 305 because of a fundamental difference between the standard and the draft EVS-GTR. (This difference also exists between FMVSS No. 305 and GTR No. 13 and ECE R.100.) The electrical safety requirements in FMVSS No. 305 apply to each high voltage source in the power train, while the electrical safety requirements in the draft EVS-GTR would apply to high voltage buses and electric circuits. This means that NHTSA determines whether the electrical safety requirements of FMVSS No. 305 apply to electric components that are connected to or part of the electric power train by individually assessing each component separately, analyzing its working voltage.31 To illustrate, in a 48-volt mild hybrid system, NHTSA will assess the working voltage of each DC component. If the working voltage of the component is not greater than 60 VDC, NHTSA does not subject it to the electrical safety requirements in FMVSS No. 305, regardless of whether it is galvanically connected to other electrical components that would be considered high voltage sources.32 Accordingly, the additional text for excluding the DC part of 48-volt mild hybrid systems from electrical safety requirements requested by the Alliance is not necessary in FMVSS No. 305.

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.

In the NPRM, NHTSA expressed disagreement with the GTR's exclusion of connectors under the floor. (See 81 FR at 12654-12655; id. at 12664.) NHTSA believed that 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 direct contact protection as other high voltage sources, including barriers providing protection degree IPXXD or IPXXB, based on whether they are located inside or outside the passenger or luggage compartment areas, respectively. Additionally, the agency noted that “vehicle floor” and “connector” are not defined in GTR No. 13.

The agency received several comments on this issue. The Alliance and Global request the regulatory text include a separate section setting forth direct contact protection requirements that connectors and the vehicle charge inlet must meet. The Alliance suggests the following definition for “connector”: “A connector is a device that provides mechanical connection and disconnection of high voltage electrical conductors to a suitable mating component, including its housing.” 33

The Alliance and Global suggest that the separate section specify that connectors and the vehicle charge inlet must provide protection degree IPXXD or IPXXB, as appropriate, when connected to its mating component. Further, each connector or vehicle charge inlet must also meet one of the following: (1) It must provide, in an uncoupled state, protection degree IPXXD or IPXXB, as appropriate, if the connector or vehicle charge inlet can be uncoupled from its mating component without a tool; (2) the voltage of the live parts become equal to or less than 60 VDC or 30 VAC within 1 second after separating from its mating component; or (3) it has a locking mechanism that prevents the connector or vehicle charge inlet from being uncoupled from its mating component without a tool.

In its comment, Tesla asks NHTSA to confirm whether various scenarios involving its connectors underneath the floor of its vehicles would meet the proposed requirements.34 Tesla requests that NHTSA clarify what we consider “acceptable” for connectors underneath the floor.35

NHTSA has reviewed the comments and agrees with the recommendations to include separate requirements for direct contact protection of connectors and vehicle charge inlets. In drafting the NPRM, we determined that connectors were high voltage sources and that they should meet all the requirements for high voltage sources. However, the commenters provide more information about connectors, pointing out that they connect high voltage cables to high voltage sources through a mating component. Like high voltage conductors (cables), connectors need to have direct contact protection. But, commenters point out, connectors are unique in that they are designed to be disconnected from their mating component. Therefore, additional safety provisions are required to ensure the safety of this coupling and re-coupling design mechanism. For this reason, we have decided there is a need to specify unique safety provisions for connectors and vehicle charge inlets.

We have based our final rule on the requirements suggested by the Alliance and Global. The requirements are harmonized with GTR No. 13, ECE R.100, and the draft EVS-GTR for electric vehicles. When a connector is connected to its mating component, it should have direct contact protection IPXXD or IPXXB based on whether the connector is inside or outside the passenger or luggage compartment, respectively. Additionally, connectors are required to meet at least one of the three following requirements: (1) It must provide protection degree IPXXD or IPXXB, as appropriate, in the uncoupled state, if the connector or vehicle charge inlet can be uncoupled from its mating component without a tool; (2) the voltage of the high voltage live parts become equal to or less than 60 VDC or 30 VAC within 1 second after separating from its mating component; or (3) it has a locking mechanism (at least two distinct actions are needed to separate the connector from its mating component) 36 and there are other components that must be removed in order to separate the connector from its mating component and these cannot be removed without the use of tools.

Regarding Tesla's recommendation that we incorporate Table 4 of ISO 6469-3 for connectors, we believe there is no need for such an amendment. ISO 6469-3 was revised in 2011 and its requirements for connectors are similar to those in this final rule.37

Regarding Tesla's inquiry about connectors underneath the floor, connectors and electrical protection barriers located under the vehicle's floor are treated the same as other connectors and electrical protection barriers located outside of the passenger and luggage compartments.38 A connector located under the floor that has IPXXB protection level and that cannot be separated from its mating component without tools would comply with the above direct contact protection requirements for connectors. (If it can be separated from its mating component without tools, it must provide protection degree IPXXB in the uncoupled state or the live parts must be equal to or less than 60 VDC or 30 VAC within 1 second from separating from its mating component). Regarding a connector located under the vehicle's floor where the access point to the connector is smaller than a finger could fit through, the connector would need to meet IPXXB protection degree if parts surrounding the connector (that limit access to the connector) can be opened, disassembled or removed without the use of tools.39

NHTSA proposed marking requirements (yellow high voltage symbol) on or near electric energy storage/conversion devices, and on electrical protection barriers in general. We proposed that the markings would not be required for electrical protection barriers that cannot be physically accessed, opened, or removed without the use of tools. The proposed provisions were based on GTR No. 13 requirements, but unlike GTR No. 13, the NPRM did not exclude from the marking requirement (1) electrical protection barriers or high voltage sources located under the vehicle floor; (2) connectors generally; or (3) the vehicle charge inlet. NHTSA also proposed that cables for high voltage sources that are not located within electrical protection barriers must be identified by an orange colored outer covering.

The agency received multiple comments on this issue.

The Alliance, Global and Subaru request that connectors be excluded from the marking requirement. The Alliance and Global state that some connectors can be so small that the markings on these connectors would be not easily read and that high voltage cables going into the connectors are required to have orange outer covers, which should signal that the cables and their connectors are high voltage. The Alliance also notes that high voltage connectors do not necessarily carry high current. The Alliance states that the inclusion of a marking requirement for connecters would necessitate product development efforts, increased economic cost and compliance burden, without a commensurate increase in safety.

Subaru believes that markings should not be necessary on or near electric storage/conversion devices which are not in plain view of vehicle occupants during normal vehicle operation. Subaru states that a device that is mounted under a seat, and that is not visible without first removing the seat, should not have to be marked.

Tesla believes that high voltage sources underneath the vehicle are subject to a harsh physical environment, and that the markings on them are not likely to survive the vehicle's life. Tesla asks NHTSA to allow for alternative placement of high voltage markings when a vehicle's high voltage source is located under the vehicle's floor.

The agency agrees with the Alliance and Global request to exclude connectors from requiring markings. The agency is persuaded by the commenters that connectors do not necessarily carry high current and that the increased economic cost and compliance burden resulting from a marking requirement are not warranted. The connectors are small, so markings on them would not be easily read. Further, we agree that since high voltage cables going into the connectors are required to have orange outer covers, those covers will sufficiently indicate that the cables and their connectors are high voltage. Importantly, the markings are also not needed because, in a change from the NPRM, we have decided to require connectors to have direct contact protection when connected and disconnected from their mating component. (As discussed above, the direct contact protection consists of IPXXD or IPXXB protection when connected to the mating component, and at least one of the following: (1) IPXXD or IPXXB protection when separated from its mating component if the connector can be uncoupled without a tool; (2) a low voltage requirement within 1 second after separation from its mating component; or (3) it cannot be uncoupled from its mating component without the use of tools. Thus, we conclude that connectors will sufficiently protect against the risk of electrical shock without the markings.

Similarly, the agency also agrees with the Alliance and Global request to exclude the vehicle charge inlet from requiring markings. The markings are not necessary because this final rule requires vehicle charge inlets to have direct contact protection when connected and disconnected from their mating component, like connectors.

The agency does not agree with Subaru's request to omit the high voltage marking on electric energy storage/conversion 40 devices that are not in plain view of vehicle occupants during normal vehicle operation. GTR No. 13, ECE R.100, and the draft EVS-GTR require the high voltage symbol on or near electric energy storage devices. Since an electric energy storage device is a high density energy source, we believe there is a safety need for the marking, as persons (such as maintenance, repair and rescue personnel and consumers working on their vehicles) encountering the electric energy storage device should be warned of the electrical shock risks. However, we are revising the proposed regulatory text to indicate that the marking on electric energy storage devices “shall be present” rather than “shall be visible.” This terminology is consistent with the draft EVS-GTR. The final rule's wording (“shall be present”) acknowledges that the marking is not, and does not have to be, “visible” on an electric energy storage device when the device is located under the floor away from view.

Thus, under this final rule, the electric energy storage device must be marked, and the electrical protection barrier for the device must also be marked with a visible high voltage symbol if it can be accessed, opened, and removed without the use of tools. To illustrate, if an electric energy storage device is accessible when the floor mat is pulled out and a floor panel is opened (without the use of tools), the floor panel has to have a high voltage symbol that is visible to the person when he/she pulls out the floor mat.

NHTSA has decided not to require electric energy conversion devices to be marked with the high voltage symbol. Electric energy conversion devices include fuel cells which convert chemical energy to electric energy. A fuel cell only becomes a high voltage source when hydrogen is supplied to it. Since conversion devices (e.g., fuel cells) are not high density energy sources, we are not requiring them to be marked. However, the electric protection barrier around a conversion device (e.g., fuel cell) will have to be marked, and the mark is required to be visible.

NHTSA does not agree with Tesla's request to allow alternative positions for the high voltage symbol mark on high voltage sources that are located underneath the vehicle's floor. We do not believe there is a need for the change as the regulatory text requires that the mark be “on or near” electric energy storage devices without providing specifics for the location of the high voltage marking. We note also that this final rule provides that electrical protection barriers that cannot be physically accessed, opened, or removed without the use of tools are excluded from the marking requirement,41 which may bear on Tesla's labeling of its devices.

Exposed conductive parts of electrical protection barriers must be protected against indirect contact 42 during normal vehicle operation and post-crash. The NPRM proposed that the resistance between exposed conductive parts of electrical protection barriers and the electrical chassis must be less than 0.1 ohms and that the resistance between any 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 (proposed S5.3(c)(2)). The NPRM also proposed (S5.3(c)(3)) that the voltages between an electrical protection barrier and other exposed conductive parts must be less than or equal to 30 VAC or 60 VDC (“low voltage requirement”). These proposed requirements would protect against electric shock if any electrically charged components lose isolation within the protective barrier and two exposed conductive parts of the electrical protection barrier are contacted simultaneously, by shunting 43 any harmful electrical current to the vehicle chassis.

Global comments that the reference to “any two simultaneously reachable exposed conductive parts” in proposed S5.3(c)(2) “would result in excessive testing requirements, due to the number of potential combinations of two simultaneously reachable exposed parts.” The commenter recommends that manufacturers be authorized to identify a “worst case” pair of conductive parts for testing under the provision to reduce the potential number of combinations. Global also recommends that greater specification for the phrase “any two simultaneously reachable,” be provided, such as a measured distance.

NHTSA believes that the regulatory text already provides the specification that the simultaneously reachable exposed conductive parts of electrical protection barriers must be located within 2.5 meters of each other. Thus, we do not believe the requirement results in an excessive number of resistance measurements. However, NHTSA is correcting the reference to “exposed conductive parts of the electrical protection barriers” in S5.3(c)(2) to qualify that they are exposed conductive parts of the electrical protection barrier of the high voltage source under consideration in S5.3.

Global comments that the low voltage requirement (S5.3(c)(3)) is too broad in scope and recommends limiting this testing requirement to exposed conductive parts of the electrical protection barriers. Global states that in the event of a barrier failure, a voltage differential could exist with regard to all exposed conductive parts of the chassis and all metal parts connected to the chassis. The Alliance comments that the requirements in S5.3(c)(3) should be consistent with the requirement in S5.3(c)(2). I.e., the Alliance believes that the voltage measurements for S5.3(c)(3) between exposed conductive parts should be made on the same exposed conductive parts of electrical protection barriers for which resistance measurements are made for S5.3(c)(2).

The agency agrees with the comments of Global and the Alliance and has worded S5.3(c)(3) to reflect the recommended changes. As adopted, S5.3(c)(3) specifies that the voltage between exposed conductive parts of the electrical protection barrier and the electrical chassis must be less than or equal to 30 VAC or 60 VDC.44 In addition, the voltage between an exposed conductive part of the electrical protection barrier and any other simultaneously reachable exposed conductive parts of electrical protection barriers within 2.5 meters of it must be less than or equal to 30 VAC or 60 VDC.

Under FMVSS No. 305's current post-crash safety requirements, vehicles must meet either electrical isolation requirements or low voltage requirements. The current requirements for electrical isolation are that the electrical isolation of the high voltage source must be greater than or equal to: 500 ohms/volt for an AC high voltage source; 500 ohms/volt for a DC high voltage source without electrical isolation monitoring during vehicle operation; or 100 ohms/volt for a DC high voltage source with an electrical isolation monitoring system during vehicle operation.

The NPRM proposed to change these requirements (S5.3(a)) and add specifications that high voltage sources must have electrical isolation during normal vehicle operation (S5.4.3.1). Briefly, the proposed electrical isolation requirements are: AC high voltage sources have 500 ohms/volt or higher electrical isolation from the electric chassis; DC high voltage sources have 100 ohms/volt or higher electric isolation from the electric chassis; or, AC high voltage sources that are conductively connected to the DC high voltage sources may have 100 ohms/volt or higher electrical isolation from the electric chassis provided they also provide physical barrier protection.

The Alliance first requests that the regulatory text of the electrical isolation option under post-crash conditions (S5.3(a)) and during normal vehicle operating conditions (S5.4.3.1) be replaced by the language in GTR No. 13.

The agency declines this request. The requirements of the electrical isolation option in FMVSS No. 305 and GTR No. 13 are identical, while the text in FMVSS No. 305 is more concise.

Second, the Alliance requests changes to the proposed physical barrier protection requirements for AC high voltage sources that are conductively connected to DC high voltage sources and that comply with the lower electrical isolation limit of 100 ohms/volt under post-crash conditions (S5.3(a)(2)). The proposed text in the NPRM permits an AC high voltage source to have an isolation resistance of only 100 ohms/volt if three physical protection requirements are met.45 The Alliance suggests that the low voltage requirement is “not logically needed.” It states that the electric shock scenario identified in NHTSA's Battelle study 46 of physical barriers will never happen if it maintains a minimum electrical isolation of more than 100 ohms/volt, protection against direct contact (IPXXB), and protection against indirect contact (resistance between exposed conductive parts and the electrical chassis and between two exposed conductive parts of less than 0.1 ohms and 0.2 ohms, respectively).

NHTSA has carefully analyzed electrical safety implications under the conditions of a minimum electrical isolation of 100 ohms/volt, resistance between exposed conductive parts of electrical protection barriers and the chassis of 0.1 ohms, and electrical isolation between two exposed conductive parts of 0.2 ohms. The results of the analysis 47 showed that under these conditions, the electric current through the body would be significantly lower than 10 milliamps (mA) DC and 2 mA AC, which are considered safe levels of current for protection from electric shock. Therefore, the agency agrees to this change in the regulatory text requested by the Alliance. Accordingly, S5.3(a)(2) is modified so that AC high voltage sources that are conductively connected to DC high voltage sources may comply with the lower electrical isolation limit of 100 ohms/volt provided they meet the physical protection requirements of S5.3(c)(1) and S5.3(c)(2).

Like GTR No. 13, the NPRM proposed (S5.4.5) to require electric vehicles whose rechargeable energy storage system are charged by conductively connecting to a grounded external power supply to have a device to enable conductive connection of the electrical chassis to the earth ground during charging. This proposal was to ensure that in the event of electrical isolation loss during charging, a person contacting the vehicle does not form a ground loop with the chassis and sustain significant electric shock. Additionally, like GTR No. 13, the NPRM proposed (S5.4.3.3) to require the isolation resistance between the high voltage source and the electrical chassis to be at least 1 million ohms when the charge coupler is disconnected. This proposal was to ensure that the magnitude of current through a human body when a person contacts a vehicle undergoing charging is low and in the safe zone.

The agency received many comments regarding the requirement for isolation resistance of 1 million ohms during charging.

The Alliance states that the requirement should only be applicable to conductive charging with an AC external electric power supply, noting that the isolation resistance of one million ohms should be required for the high voltage source (high voltage buses) that are conductively connected to the contacts of the vehicle charge inlet, and not to the vehicle charge inlet itself.

Mercedes-Benz states that the 1 million ohms isolation resistance specification—

Tesla states that it does not believe the insulation resistance requirement for the vehicle's inlet is aligned with the associated high voltage hazards that the NPRM proposes to mitigate. Tesla believes that the intent of the insulation resistance requirement is to prevent high voltage current from flowing through the human body. Tesla believes that Section 11.7 of the IEC 61851-1:2010 48 more accurately captures this prevention for AC equipment because it specifically applies to cord and plug-connected equipment. Tesla also recommends that NHTSA “provide clear requirements for off-board (including charging) equipment(s)” since any fault current that is generated while charging would be a function of both the vehicle as well as the electric vehicle supply equipment.

To evaluate these comments, NHTSA requested information from technical experts in the working group for the draft EVS-GTR on electric vehicle safety, in which NHTSA participates. Technical information was provided by Mr. Takahiko Miki 49 from the Organisation Internationale des Constructeurs d'Automobiles (OICA).50 Mr. Miki noted that the one million ohms electrical isolation requirement is from IEC 61851-1. Mr. Miki also noted that the requirements in IEC 61851-1 apply to conductive charging of electric vehicles with an AC external electric power supply.

Mr. Miki provided the following detailed explanation of protective measures in vehicles during charging to prevent electric shock. Mr. Miki noted that protection against electric shock during charging by connecting to an AC external electric power supply is provided by the vehicle and the off-board electric vehicle supply equipment (i.e. charge connector) and provided a description of these protection systems. Protection systems in the vehicle include: (1) Protection against direct contact with high voltage live parts and (2) indirect contact protection from high voltage sources (equipotential bonding—earthing/grounding). Protection systems in the electric vehicle supply equipment (charge connector) include: (1) Earthing/grounding conductor between the electrical chassis of a vehicle and the earth/ground, (2) earthing/grounding continuity monitor, and (3) automatic disconnection of supply (residual current device (RCD),51 charging circuit interrupting device (CCID) 52 located in the charge electric vehicle supply equipment or in the fixed electrical installation, or both) operated by the fault current that disconnects one or more of the line conductors.

The AC external electric power supply is grounded to earth ground. When an electric vehicle is connected to the AC external electric power supply by the charge connector, the vehicle electrical chassis is connected to the earth/ground through the earthing/grounding conductor. If electrical isolation/insulation is lost during charging, the leakage current (residual current) 53 would flow to the earth/ground through the earthing/grounding conductor. Under such conditions, a human body contacting high voltage-exposed conductive parts of the vehicle would not experience electric shock if the leakage current is less than or equal to maximum current levels considered to be safe. If the leakage current reaches or exceeds specified safety threshold levels, the RCD/CCID would open the circuit to interrupt the supply of electric energy. A similar form of this type of electric shock protection measure is provided in homes for use of common household electric equipment.

The electrical isolation of high voltage sources that are connected to the vehicle charge inlet during charging by connecting the AC external electric power supply is determined based on the characteristics of the RCD/CCID to ensure that leakage current would be significantly lower than the leakage current level that would trip the RCD/CCID to open the circuit. This electrical isolation requirement is not for electric shock protection but to ensure that charging is not interrupted under normal charging conditions. Mr. Miki recommends that the electrical isolation between the electrical chassis and high voltage sources that are conductively connected to the vehicle charge inlet during AC charging be greater than or equal to 500 ohms/volt because with this level of electrical isolation, the leakage current would be sufficiently lower than the leakage (residual) current level that would trip the RCD/CCID to open the circuit and interrupt the electric energy supply.54

In light of the new information provided by Mr. Miki and the commenters, the agency is modifying the proposed isolation resistance requirement for high voltage sources for charging the electric energy storage device (S5.4.3.3). High voltage sources conductively connected to the vehicle charge inlet during charging (through conductive connection to the AC external electric supply) are required to have electrical isolation from the electric chassis of 500 ohms/volt when the charge connector is disconnected.

We believe the modified language responds to the comments from the Alliance, Mercedes-Benz, and Tesla. Additionally, the modified requirement is consistent with that developed in the draft EVS-GTR for electric vehicles.

Regarding Tesla's recommendation for NHTSA to provide clear requirements for off-board (including charging) equipment, the agency is looking into this matter. The safety measures in the electric vehicle supply equipment, such as the RCD/CCID in the charge connector, are specified in the National Electric Code (NEC)—Article 625: Electric Vehicle Charging System and in the Underwriters Laboratory (UL) 2954, “Electric vehicle supply equipment.” Adding requirements for off-board equipment is not in scope of this final rule since the agency did not include any such requirements in the NPRM. The agency may consider the need for and the feasibility of requirements for off-board electric vehicle equipment in the future.

NHTSA proposed three provisions for mitigating the likelihood of driver error in operating electric vehicles (S5.4.6). First, the heading and text of proposed S5.4.6.1 proposed that at least a momentary indication shall be given at “start up” when the vehicle is in a possible active driving mode.55 (“Start up” is also used in GTR No. 13.) Second, the NPRM proposed that drivers be provided an audible or visual signal if the vehicle is still in the possible active driving mode when the driver leaves the vehicle. Third, for vehicles that have on-board electric energy storage devices that can be charged externally, the NPRM proposed to prohibit vehicle movement by the vehicle's own propulsion system when the external electric power supply is physically connected to the vehicle charge inlet.

The agency received comments from Global, the Alliance and Tesla on the proposal. Global requests a clarification of the meaning of “start up” used in the first provision. Global asks if “start up” refers to the time of engine start or some other meaning.

NHTSA meant “start up” to refer to the time when the vehicle is first placed in a possible active driving mode (e.g., reverse, drive, or other driving gears) after manual activation of the propulsion system. The provision at issue is intended to reduce operational errors that could have safety implications. For example, a driver might not realize the vehicle is in an active driving mode when he or she pressed on the accelerator pedal, which could result in a potential crash condition. However, to reduce ambiguity, we have modified the final rule regulatory text by replacing the phrase, “upon start up,” with the phrase, “when the vehicle is first placed in possible active driving mode after manual activation of the propulsion system.” Once driving is initiated, notification is not needed when the vehicle is put in neutral to change gears (for manual-drive vehicles).

The Alliance believes the heading of the third provision for mitigating driver error should be revised from “Prevent drive-away during charging” to “Prevent drive-away” to reflect that the concern is that the driver may drive the vehicle away after charging is completed without disconnecting the charge connector. The Alliance also notes that a simple physical connection without any conductive connection may not be detected by vehicle systems. The commenter recommends changing the phrase, “physically connected to the vehicle charge inlet,” to “physically connected to the vehicle charge inlet in such a way that charging is possible.”

The agency agrees generally with the Alliance's recommended changes and has changed the proposed regulatory text. We believe the changes improve clarity and removes ambiguity about when and under what conditions the requirement to prevent vehicle movement applies.56

Tesla states that the phrase, “preventing physical vehicle movement by its own power,” is vague and needs clarification. Tesla requests that the agency draw a clear distinction between when a vehicle is considered stationary and when it is in “movement under its own power.” The commenter suggests using a provision in FMVSS No. 114, “Theft protection and rollaway prevention.” S5.2.5 of FMVSS No. 114 specifies that a vehicle must not move more than 150 mm on a 10 percent grade when the gear selection control is locked in “park.”

The agency sees merit in Tesla's suggestion to improve objectivity of the requirement for preventing vehicle movement when the charge connector is connected to the vehicle charge inlet. S5.2 in FMVSS No. 114 specifies provisions to prevent rollaway in vehicles equipped with a transmission with a “park” position. One provision is that when the vehicle is resting on a 10 percent grade and the vehicle's gear selection control is locked in “park,” the vehicle must not move more than 150 mm when the brakes are released. To distinguish minor vibrations of the vehicle when it is idling from vehicle movement “under its own power,” the agency is modifying the proposed regulatory text to state that the vehicle must not move more than 150 mm 57 by its own propulsion system when the charge connector is physically connected to the vehicle charge inlet in such a way that charging is possible.

The NPRM proposed test procedures for evaluating IPXXB and IPXXD direct contact protection (S9.1), measuring resistance between exposed conductive parts and between an exposed conductive part and the electrical chassis to evaluate indirect contact protection (S9.2), and measuring voltage between exposed conductive part of an electrical protection barrier and the electrical chassis or any other exposed conductive part of the vehicle for indirect contact protection (S9.3).

For evaluating direct contact protection, the proposed test procedure in S9.1 detailed how the IPXXB and IPXXD probes are used and manipulated to determine if high voltage live parts are contacted. Subaru comments that the description of manipulating the IPXXB finger probe does not specifically note that it is only applicable to the IPXXB probe and not the IPXXD probe. NHTSA agrees and has corrected this omission to indicate that the described manipulation of the finger probe only applies to the IPXXB probe.

In proposed S9.1 the NPRM did not explicitly provide criteria for assessing whether high voltage live parts were contacted, though such information is provided in GTR No. 13. To make S9.1 clearer, and to better harmonize the test procedure in FMVSS No. 305 with that in GTR No. 13, the criteria for verification of IPXXD and IPXXB protection degree in GTR No. 13 are included in the regulatory text.

For measuring resistance between two exposed conductive parts, the NPRM at S9.2 provided two methods that could be used. Global states that the two methods were provided in GTR No. 13 as compliance options for manufacturers to select for evaluating indirect contact protection. The commenter recommends we include regulatory text to make clear that it is at the manufacturer's option to choose either test method to certify compliance. The agency agrees that the two methods were provided as compliance test options for manufacturers and has included the recommended regulatory text in S9.2 of FMVSS No.305.

Global expresses concern that provisions for indirect contact protection in S9.2 create an inordinate certification burden on manufacturers due to the phrase, “any two exposed conductive parts.” The commenter requests that instead of measuring the resistance between two exposed conductive parts, resistance may be calculated using the separately measured resistances of the parts of the electrical chassis.

NHTSA agrees with this requested change from Global. The agency notes that GTR No. 13, ECE R.100, and the draft EVS-GTR permit resistances to be calculated using the separately measured resistances of the relevant parts in the electric path. NHTSA believes that a calculation option is acceptable for the requirement at issue because resistances can be computed from other measured resistances on an actual vehicle in a straightforward manner, and do not involve potentially subjective judgment calls on the part of evaluators as to whether assumptions underlying a calculation are merited.

For measuring voltage between exposed conductive parts of electrical protection barriers, the NPRM specified a method in which the DC power supply, voltmeter, and ammeter are connected between measuring points. The Alliance and Global point out that the DC power supply should not be connected in this test (S9.3a). The agency agrees and has corrected the regulatory text. Additionally, NHTSA believes that calculating the voltage between two exposed conductive parts from the measured voltages between the exposed conductive parts and the electrical chassis is straightforward and unambiguous and so is permitting a calculation option for determining voltage between exposed conductive parts.

The proposal provided specifications of the IPXXB probe in Figure 7b of the regulatory text. The Alliance and Global note errors in the specification for R2 and R4. The agency has corrected the errors in Figure 7b.

The Alliance and Global provide an improved Figure 8 in which the text is clearer than the NPRM's Figure 8. The agency has included the new figure in FMVSS No. 305.

The NPRM proposed a compliance date of 180 days after the date of publication of the final rule in the Federal Register, with optional early compliance permitted.

The Alliance states that, although the proposed amendments to FMVSS No. 305 are vital to enable the production of advanced fuel cell and 48-volt mild hybrid vehicles, the “in use” requirements may require some modification of currently-certified electric vehicles. The commenter asks that the compliance date be modified to align it with the first September 1st that is at least 180 days after the publication of the final rule in the Federal Register, with optional early compliance permitted. An individual, Mr. Albert Torres, also believes that a longer compliance date should be provided.

The agency believes that most, if not all, electric-powered vehicles currently sold in the United States would be able to comply with the updated requirements in FMVSS No. 305 by the proposed compliance date. However, as noted by the Alliance, some vehicles may need some minor modifications to comply with some of the modifications in FMVSS No. 305, such as the marking requirements. Therefore, the agency finds good cause to provide more time to comply with this final rule. The agency believes one year from the date of publication of the final rule is sufficient time for vehicle manufacturers to comply with the updated FMVSS No. 305 requirements. Therefore, the compliance date for the amendments in FMVSS No 305 is one year after publication of the final rule. We permit optional early compliance with this final rule.

We note that in the “DATES” section at this beginning of this document NHTSA indicates that the “effective date” of this final rule is the date of publication of the rule. The “effective date” in the DATES section is the date the amendments should be incorporated into the CFR. That date is different from the “compliance date” discussed above. As stated above, NHTSA is permitting optional early compliance with this final rule. Because of this, we are amending 49 CFR 571.305 (FMVSS No. 305) on the date of publication of this final rule so that interested manufacturers can begin certifying the compliance of their vehicles with the amended standard from that date.

This rulemaking document was not reviewed by the Office of Management and Budget (OMB) under Executive Order (E.O.) 12866. It is not considered to be significant under E.O. 12866 or the Department's Regulatory Policies and Procedures. The amendments made by this final rule will have no significant effect on the national economy, as most of the requirements are already in voluntary industry standards and international standards that current electric powered vehicles presently meet.

This final rule updates FMVSS No. 305 to incorporate the electrical safety requirements in GTR No. 13. This final rule also responds to petitions for rulemaking from Toyota and the Alliance to facilitate the introduction of fuel cell vehicles and 48-volt mild hybrid technologies into the vehicle fleet. The final rule adds electrical safety requirements in GTR No. 13 that involve electrical isolation and direct and indirect contact protection of high voltage sources to prevent electric shock during normal operation of electric powered vehicles. Today's final rule also provides an additional optional method of meeting post-crash electrical safety requirements that involve physical barriers of high voltage sources to prevent electric shock due to direct and indirect contact with live parts. Since there is widespread conformance with the requirements that would apply to existing vehicles, we anticipate no costs or benefits associated with this rulemaking.

Executive Order 13771 titled “Reducing Regulation and Controlling Regulatory Costs,” directs that, unless prohibited by law, whenever an executive department or agency publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed. In addition, any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs. Only those rules deemed significant under section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” are subject to these requirements. As discussed above, this rule is not a significant rule under Executive Order 12866 and, accordingly, is not subject to the offset requirements of 13771.

NHTSA has determined that this rulemaking is a deregulatory action under E.O. 13771, as it imposes no costs and, instead, amends FMVSS No. 305 to give more flexibility to manufacturers not only to use modern electrical safety designs to produce electric vehicles, but also to introduce new technologies to the U.S. market, including hydrogen fuel cell vehicles and 48-volt mild hybrid technologies. Although NHTSA was not able to quantify any cost savings for this rule, in adopting an optional method of meeting post-crash electrical safety requirements involving use of physical barriers to prevent direct or indirect contact (by occupants, emergency services personnel and others) with high voltage sources, this final rule adjusts the standard to remove an obstruction that prevented HFCVs to be offered for sale in the U.S. Use of the physical barrier option will also enable manufacturers to produce 48-volt mild hybrid systems without having to use electrical isolation safety measures that involve more complexity, higher consumer costs, and higher mass, without an incremental safety benefit.

NHTSA has considered the effects of this final rule under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996). I certify that this final rule will not have a significant economic impact on a substantial number of small entities. Any small manufacturers that might be affected by this final rule are already subject to the requirements of FMVSS No. 305. Further, the agency believes the testing associated with the requirements added by this final rule are not substantial and to some extent are already being voluntarily borne by the manufacturers pursuant to SAE J1766. Therefore, to the extent there is an economic impact on the manufacturers, it will only be minor.

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

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

NHTSA rules can have preemptive effect in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemption provision:

When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter. 49 U.S.C. 30103(b)(1).

It is this statutory command that preempts any non-identical State legislative and administrative law 58 addressing the same aspect of performance, not today's rulemaking, so consultation would be inappropriate.

Second, the Supreme Court has recognized the possibility, in some instances, of implied preemption of State requirements imposed on motor vehicle manufacturers, including sanctions imposed by State tort law. That possibility is dependent upon there being an actual conflict between a FMVSS and the State requirement. If and when such a conflict exists, the Supremacy Clause of the Constitution makes the State requirements unenforceable. See Geier v. American Honda Motor Co., 529 U.S. 861 (2000), finding implied preemption of state tort law on the basis of a conflict discerned by the court,59 not on the basis of an intent to preempt asserted by the agency itself.

NHTSA has considered the nature (e.g., the language and structure of the regulatory text) and objectives of today's final rule and does not discern any existing State requirements that conflict with the rule or the potential for any future State requirements that might conflict with it. Without any conflict, there could not be any implied preemption of state law, including state tort law.

With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729; Feb. 7, 1996), requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) specifies whether administrative proceedings are to be required before parties file suit in court; (6) adequately defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement.

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

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

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

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, as amended by Public Law 107-107 (15 U.S.C. 272), directs the agency to evaluate and use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or is otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as the Society of Automotive Engineers (SAE). The NTTAA directs us to provide Congress (through OMB) with explanations when the agency decides not to use available and applicable voluntary consensus standards. The NTTAA does not apply to symbols.

FMVSS No. 305 has historically drawn largely from SAE J1766, and does so again for this current rulemaking, which updates FMVSS No. 305 to facilitate the development of fuel cell and 48-volt mild hybrid technologies. It is based on GTR No. 13 and the latest version of SAE J1766 January 2014.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). Adjusting this amount by the implicit gross domestic product price deflator for the year 2013 results in $142 million (106.733/75.324 = 1.42). This final rule will not result in a cost of $142 million or more to either State, local, or tribal governments, in the aggregate, or the private sector. Thus, this final rule is not subject to the requirements of sections 202 of the UMRA.

The policy statement in section 1 of Executive Order 13609 provides, in part: the regulatory approaches taken by foreign governments may differ from those taken by U.S. regulatory agencies to address similar issues. In some cases, the differences between the regulatory approaches of U.S. agencies and those of their foreign counterparts might not be necessary and might impair the ability of American businesses to export and compete internationally. In meeting shared challenges involving health, safety, labor, security, environmental, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation. International regulatory cooperation can also reduce, eliminate, or prevent unnecessary differences in regulatory requirements.

The agency participated in the development of GTR No. 13 to harmonize the standards of fuel cell vehicles. As a signatory member, NHTSA is obligated to initiate rulemaking to incorporate electrical safety requirements and options specified in GTR No. 13 into FMVSS No. 305. The agency has initiated rulemaking by way of the March 10, 2016 NPRM and completes it with this final rule.

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

Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

• Have we organized the material to suit the public's needs?

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that isn't clear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rule easier to understand?

If you have any responses to these questions, please write to us with your views.

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