Federal Register Vol. 81, No.184,

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain IAE V2500-A1 turbofan engines. The NPRM published in the Federal Register on April 13, 2016 (81 FR 21768). The NPRM was prompted by a report of an uncontainment caused by a HPT seal release. The NPRM proposed to require removing from service the HPT No. 4 bearing front seal seat, P/Ns 2A0066, 2A1998, and 2A3432, and the HPT No. 4 bearing rear seal seat, P/Ns 2A0067, 2A1999, and 2A3433, and replacement with parts eligible for installation. This AD would also require inspecting the HPT rotor and stator assembly, and, if necessary, their replacement with parts that are eligible for installation. We are issuing this AD to correct the unsafe condition on these products.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (81 FR 21768, April 13, 2016) and the FAA's response to each comment.

Air India Ltd. (AIL) commented that the fracture of the HPT stage 2 seal is a known problem with the type design. AIL does not agree that the root cause of the failure is clogged No. 4 bearing seal seats. AIL finds that increases in oil consumption and/or vibration signature are precursors to failure of the HPT stage 2 seal. We interpret AIL's comment as a request to allow monitoring of oil consumption rate and vibration signature analysis instead of the requirements of this AD.

We disagree. We disagree with AIL's analysis of the unsafe condition because although other failure modes leading to fracture of the HPT stage 2 seal exist, the uncontained part release noted in the NPRM (81 FR 21768, April 13, 2016) was caused by blockage of the No. 4 bearing seal seat's anti-weep circuit. We disagree with allowing oil consumption monitoring and vibration signature analysis because they do not provide an acceptable level of safety for engines with seal seats processed using methods susceptible to oil blockage. We did not change this AD.

AIL commented that we should delay compliance to this AD until December 31, 2017. This additional time to comply with this AD would allow for minimal disruption to its fleet operations. AIL indicated that fleet safety would be maintained through engine oil consumption monitoring and vibration signature analysis.

We disagree. As noted in our previous comment response, oil consumption monitoring and vibration signature analysis do not provide an acceptable level of safety for engines with seal seats processed using methods susceptible to oil blockage. We did not change this AD.

AIL commented that the applicability of this AD should not be limited to the IAE V2500-A1 fleet.

We disagree. The applicability of this AD is limited to the IAE V2500-A1 engines with affected serial numbers because this population of engines has been identified as having been processed using methods that could lead to failure of the HPT stage 2 seals. We did not change this AD.

IAE and Airbus commented that we should include an end date of December 31, 2016, for compliance with this AD.

We disagree. Our analysis of the unsafe condition determined that blockage of the No. 4 bearing seal seat anti-weep grooves is a function of engine cycles rather than time in service. We therefore did not base compliance on a calendar date. We did not change this AD.

IAE and Airbus commented that not mandating oil monitoring and inspection of the turbine case weep-hole may increase risk to operators if they follow only the requirements of this AD. IAE indicated that this AD should match the compliance requirements of IAE SB V2500-ENG-72-0670, dated March 14, 2016.

We disagree. We find that the actions required by this AD adequately address the unsafe condition represented by the possibility of failure of the HPT stage 2 seals while not imposing unnecessary burdens on operators. We did not change this AD.

We revised the compliance section to allow installed No. 4 bearing front and rear seal seats to be returned to service following removal and refurbishment.

We reviewed the relevant data, considered the comments received, 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 NPRM (81 FR 21768, April 13, 2016) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (81 FR 21768, April 13, 2016).

We reviewed IAE Non-Modification Service Bulletin (NMSB) V2500-ENG-72-0670, dated March 14, 2016. The NMSB identifies affected engines and provides guidance for replacing the No. 4 bearing front and rear seal seats and for inspecting the HPT rotor and stator assembly. 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 0 engines installed on airplanes of U.S. registry. We estimate that it will take about 10 hours to perform the seal seat replacement. The average labor rate is $85 per hour. We also estimate the cost of No. 4 bearing front and rear seal seats to be $13,562. Based on these figures, we estimate the cost of this AD on U.S. operators to be $0.

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

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

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

The 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 D and E airspace at Sioux Gateway/Col. Bud Day Field, Sioux City, IA.

On April 13, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class D airspace, Class E surface area airspace and Class E airspace extending upward from 700 feet above the surface at Sioux Gateway/Col. Bud Day Field, Sioux City, IA (81 FR 21772) FAA-2015-7487. The Class E airspace area designated as an extension also would be removed as the extension is no longer needed. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received from Thomas Glennon, Aeronautical Information Services, citing a correction to the geographic coordinates for Martin Field, South Sioux City, NE., which has been incorporated into this final rule.

Class D and E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A 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 surface area airspace and Class E airspace extending upward from 700 feet above the surface at Sioux Gateway/Col. Bud Day Field, Sioux City, IA. The Class E airspace area designated as an extension also would be removed as the extension is no longer needed. After review, the FAA found that due to the decommissioning of the Gateway NDB, cancellation of the NDB approaches at the airport, advances in GPS capabilities, and implementation of RNAV procedures at Sioux Gateway/Col. Bud Day Field, the Class E airspace designated as a surface area no longer requires extensions and is reduced to within a 4.3-mile radius of the airport; the Class E airspace designated as an extension to the Class D or Class E surface area is removed; and the Class E airspace area extending upward from 700 feet above the surface at the airport is reduced from a 7-mile radius to a 6.8-mile radius, with the northwest extension increased from 3 miles to 3.9 miles each side of the Sioux City VORTAC 319° radial extending from the 6.8-mile radius to 14.4 miles vice 25.3 miles; the northwest extension remains unchanged 4 miles each side of the 001° bearing from the airport from the 6.8-mile radius to 12 miles. The extensions to the southeast and northwest on the Sioux City VORTAC 316° radial are no longer required. All modifications to the Class E airspace are in accordance with airspace requirements specified in FAA Joint Order 7400.2K. This action is necessary for the safety and management of IFR operations under standard instrument approach procedures at the airport. The geographic coordinates for Martin Field, South Sioux City, NE., are amended for the existing Class D and E airspace areas.

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:

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 controlled airspace at Truckee-Tahoe Airport, Truckee, CA.

On December 18, 2015, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to amend Class E airspace extending upward from 700 feet above the surface at Truckee-Tahoe Airport (80 FR 78988) Docket No. FAA-2015-4074. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received requesting the FAA to establish Class E surface airspace within a 4.2 mile radius to increase safety and enhance existing instrument flight rules (IFR) procedures in the immediate vicinity of the airport. The FAA concurred with the comment and on April 22, 2016, published in the Federal Register a supplemental notice of proposed rulemaking (SNPRM) to establish Class E surface airspace at Truckee-Tahoe Airport (81 FR 23658) Docket No. FAA-2015-4074. 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 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A 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 establishes Class E surface area airspace within a 4.2-mile radius of Truckee-Tahoe Airport, Truckee, CA. Also, this action modifies Class E airspace extending upward from 700 feet above the surface to within a 4.2-mile radius of the airport, with segments extending from the 4.2-mile radius to 19 miles north and 16.5 miles northwest of the airport, and removes reference to Homewood Seaplane Base, which is no longer operational.

Airspace modification is necessary to ensure the safety and management of standard instrument approach and departure procedures for IFR operations at the airport, with a minimum degree of airspace restriction.

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 5-6.5a. 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:

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 establishes controlled airspace at Houston Executive Airport, Brookshire, TX.

On March 28, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class D and Class E Airspace at Houston Executive Airport, Brookshire, TX (81 FR 17114) Docket No. FAA-2014-0742. Houston Executive Airport opened an operating control tower October 1, 2014. Federal regulations (14 CFR 91.126, 91.127, and 91.129) establish airspace requirements around an operating tower. Interested parties were invited to participate in three informal meetings with the local community held on June 17, June 18, and December 15, 2015, during the course of establishing this airspace, and in this rulemaking effort by submitting written comments on the proposal to the FAA. 146 comments were received by the end of the comment period May 12, 2016. An additional five comments were received after the comment period (one having 322 signatures on a petition opposing the upper altitude limit of 2,700 feet MSL; the petition supports 2,000 feet MSL as acceptable and safer). One commenter requested to withdraw his request. Of the 150 comments, many voiced opinions on different aspects of the proposal as described in more detail below.

The FAA received multiple comments from 150 commenters that have been grouped to reflect general subject areas. The groups are categorized as follows;

1. Comment: Support of the Class D proposal at 2,500 feet.

Fifty-one comments supported the proposal, as is, with a top of 2,500 feet MSL. The positive comments ranged from support of the proposal at 2,500 feet MSL to extending and expanding controlled airspace to 2,700 feet MSL. One commenter proposed to increase the upper limit to 2,700 feet MSL. There were a variety of reasons cited in support of the proposal, including the following:

(a) Confusing to have an air traffic control tower but no Class D airspace surrounding the airport. Establishing class D airspace on the FAA sectionals charts will better identify the air traffic control tower to our transient and overflying aircraft.

(b) The air traffic control tower will enhance the safety of the operations and support the continued growth of the airport. Standard clearance from Houston Executive Airport is to maintain heading to 2,000 feet. Don't want aircraft at 2,100 feet. Aircraft transitioning along I-10 are in the direct flight path of departing traffic off TME RWY 18. Aircraft flying over I-10 at 2,000 feet without communicating with the tower could easily result in mid-air collision with departing traffic.

(c) Limiting airspace to 2,000 feet will only encourage pilots to transition the airspace with no communication, which is dangerous.

(d) A few miles north of the airport the Class B airspace begins at 3,000 feet but the majority of the Class B area over the airport is 4,000 feet.

(e) Simply requesting a transition to the tower will make everyone aware of the transitioning aircraft.

(f) The airspace is usually congested with pilots landing or departing Houston Executive Airport or nearby airports and pilots flying VFR alongI-10 at 2,500 feet Class D ceiling is the ceiling pilots have been taught to fly.

(g) Should declare the full circle of 4 NM radius as Class D, including surface to 2,700 feet MSL as done at KHY, KAFW, KFWS, KADS.

(h) The rule if adopted would make the controlled airspace around Houston Executive Airport consistent with comparable towered airfields in the U.S. Sugarland and Conroe were given higher ceiling altitudes than 2,500 feet.

(i) Houston Executive Airport is only airport on the west side of Houston on the I-10 corridor with the ability to handle large cabin class aircraft and a runway length of 6,610 feet.

(j) Not true that having the top of the Class D airspace at 2,500 feet “squeezes VFR aircraft into a narrow band.” It is a simple matter to call Houston Executive Tower and coordinate a clearance to transit the Class D airspace or call Houston Approach and get a clearance to transit through the Class B airspace. Support for Class D Airspace, but radar is necessary.

FAA response: An operating tower that meets 14 CFR part 91 regulations is entitled to the establishment of airspace around the tower. Houston Executive Airport (TME) became operational on October 1, 2014. Unless otherwise authorized or required by ATC, 14 CFR 91.126 and FAA Order 7400.2 states that no person may operate an aircraft to, from, or through, an airport having an operational control tower unless two-way radio communications are maintained between that aircraft and the control tower. Communications must be established prior to 4-nautical miles from the airport, up to and including 2,500 feet AGL.

Although the FAA initially considered a top altitude of 2,700 feet, based on feedback from the first informal meeting and considerations for the safe and efficient use of airspace, the FAA determined that 2,500 feet, as provided in 14 CFR 91.126, is an appropriate altitude for the operations at the airport based on further information received from informal meetings, radar operating practices, and surveillance equipment. The airspace was tailored to provide minimum inconvenience while optimizing safety. Radar equipment is not a requirement for a control tower. This particular tower is a Non Federal Contract Tower; the FAA is not responsible for providing this type of equipment. Currently, airport traffic activity does not meet the threshold for establishing a radar environment.

2. Comment: Support of the Class D airspace at 2,000 feet.

Seventy-six comments opposed the 2,500-foot top and another 322 signed a late-filed petition opposing the altitude of 2,500 feet. This group of 398 did support the creation of the airspace if the top altitude was 2,000 feet MSL. They said reducing tower coordination with a 2,000-foot altitude, and allowing for more separation of airspace between Class B and Class D, would provide a greater and safer transition for aircraft flying along Houston's east/west corridor.

Some of the reasons for limiting top of airspace to 2,000 included:

(a) Other airports (DWH, HQZ, GKY, and SGR) have a top altitude of 2,000 feet.

(b) A 2,500 foot MSL will severely restrict approaches and departures at IWS.

(c) A 2,000 foot ceiling or lower could lessen the effect on the KIWS traffic located 12 NM E of TME, which has a high proportion of VFR and sport pilot traffic. Most IFR departures from KIWS (Runway 15) are cleared to enter controlled airspace heading 270 degrees at 2,000 feet.

(d) Industry standard for Class D is a tower with a 4-NM radius and 2,000 feet MSL.

(e) The most commonly used altitudes are around 1,500 feet; this ensures clearance along the entire route of class B at 2,000 feet and 1000 feet minimum altitude over densely populated terrain. It is also common for westbound traffic to stay just north of I-10 and east-bound traffic stays south of I-10. Much of this VFR traffic doesn't want to communicate with the KTME tower. The wisdom of providing only 500 feet of space between the top of class D and the base of Class B (3,000 feet MSL) within two Victor Airways is in question. By establishing the upper limit of the Class D Airspace to 2,000 feet MSL, pilots would have a 500-foot separation from traffic in both Class B and Class D airspace, instead of only 250 feet separation under the proposal.

FAA response: Transiting VFR aircraft are able to fly through this airspace at 2,000 feet by establishing radio communications and receiving approval by the tower based on the air traffic situation. The same aircraft can fly over the airspace at 2,501 feet without communicating with the tower. The potential for aircraft to be departing Houston Executive Airport and climbing to 2,000 feet with aircraft overflying the same area at 2,001 feet does not provide an adequate safety net. Although there was a comment that Sugar Land Airport had a 2,000 foot top altitude, a review of this comment reveals a top altitude up to, but not including 2,600 feet. David Wayne Hooks Airport does have up to but not including a 2,000 foot top altitude; however, this airport underlies Class B airspace that begins at 2,000 feet. An IFR exit to the west of DWH is capped at 2,000 feet. In making its decision, the FAA reviewed the operations at the airport, informal meeting notes, radar operating practices, and surveillance equipment. With respect to the comment about victor airways, they are in a small section of the class D footprint. Approximately 10 percent underlie Class B Shelf at 3,000 feet. Controlled traffic on V-68 andV-222 will be at 3,000 feet or higher. VFR aircraft are knowledgeable about these airways and are to maneuver themselves to be clear of other aircraft, see and avoid. The airspace was tailored to provide minimum inconvenience while optimizing safety. The FAA has determined that 2,500 feet is an appropriate altitude to enhance safety and allow flexibility to the VFR pilot.

3. Comment: Support of the Class D proposal at 1,700 feet.

One commenter supported Class D airspace with an altitude of 1,700 feet.

FAA response: 14 CFR 91.129 sets minimum altitudes when operating in Class D airspace, unless otherwise required, by the distance from cloud criteria; each pilot of a turbine-powered airplane and each pilot of a large airplane must climb to an altitude of 1,500 feet above the surface as rapidly as possible. The FAA has determined that 2,500 feet is an appropriate altitude to enhance safety and allow flexibility to the VFR pilot.

4. Comment: Support for Class D at 2,500 feet but with Full Circle (4 miles) Airspace without Cutout for Sport Flyers Airport.

FAA response: The informal meetings with the community resulted in reducing the size of the proposed Class D to its current cutout shape. This proposal reduces the allowed 4-nautical mile radius around TME to assist the operators transitioning in and out of Sport Flyers Airport without the need of establishing radio communications with TME. The proposed cutout also allows for accommodation of a private airstrip to the southwest of TME. This cutout complies with established rules in FAA Order 7400.2K Chapter 17-2-3, SATELLITE AIRPORTS, paragraph a. Using shelves and/or cutouts to the extent practicable, exclude satellite airports from the Class D airspace area.

5. Comment: Concerns of east-west VFR corridor compression.

Forty-eight comments were received as to this loss of airspace and to the creation of airspace above 2,000 feet as a safety issue, having a major impact on the VFR community. They commented that the east/west corridor along I-10 has long been a familiar route for VFR pilots transitioning through the airspace for the last thirty years; they enjoy the visual reference and not having to communicate with small airports at the accustomed altitude of 2,000 feet. Comments included:

(a) Compressing transient VFR traffic along I-10 corridor to 500′ vertically will increase risk of collision.

(b) Will make flying cross country more stressful.

(c) Proposed airspace is dangerous because it sits at the mouth or exit of the VFR corridor between the two huge Class B airspaces over Houston.

(d) KTME does not need Class D because it does not have a lot of traffic and it is not for the common good of all.

(e) Proposed airspace significantly reduces usable airspace for the majority to accommodate a few elite jets; Safety should be for the most pilots, not the richest. There are only a few IFR days where Class D might be beneficial; but there are many VFR flyers.

(f) Class D should not be implemented until tower existence is published.

(g) Will cause transition to South and cause flights and noise over residential areas of Katy, Cinco Ranch, and Brookshire. Should consider these alternatives: (1) No Class D; (2) Class D ceiling 1,500 AGL rather than 2,000 AGL; (3) Make southern border of Class D align with northern edge of I-10.

(h) VFR traffic will deviate around the south side putting west and east-bound traffic on potential collision course for the following reasons:

(1) By establishing Class D around KTME, this VFR traffic will choose to deviate around the south side of the proposed Class D. That will put west- and east-bound traffic on a potential collision course. Although in practice VFR traffic is often at 1,500′ even this far out west, it could fly at a higher altitude. However, even the Houston VFR flyway chart encourages VFR traffic to stay below 2,500′ in this area. Adhering to that recommended altitude would still require a deviation south around the proposed KTME Class-D, so the safety concern noted above still stands.

(2) VFR aircraft flying in opposite directions would normally have a 1,000 ft. separation between themselves (whole altitudes + 500 ft.). With only 1,500 foot above TME (2,500 ft to 4,000 ft) . . . what are the procedures for safe separation??? IFR are at the whole altitudes! So . . . If TME Class D has a ceiling of 2,500 ft, 2,600 ft to 3,900 ft is all that is left! In such a case. Only one VFR altitude is available [Eastbound: 3,500 ft] [FAR Part 91.159] and that leaves Westbound VFR traffic with dangerous choices. VFR traffic flying over TME at 2,100 with a 2,000 ft. corridor above TME is less likely than VFR traffic using 2,600 or 3,900 in a 1,500 ft. corridor. Westbound VFR won't have any option that will give them more than 400 ft. separation from Eastbound VFR or IFR traffic.

(i) Would have to drop 1,500 feet in order to land at West Houston Airport when coming from the West. Would we be better off with this traffic flying over Houston at 10,000 feet or around the Class B airspace?

(j) This would interfere with all the commercial flights coming into IAH and HOU.

(k) Directly effects VFR traffic on Victor airways.

(l) Rather than speak with the tower at KTME, aircraft will in all likelihood divert either north or south. This then increases over flights to X09 and the Gloster (1XO7) skydive location JIM MAIM.

(m) Eliminates practice area used by local pilots.

(n) IFR has no priority over VFR in uncontrolled airspace.

(o) Same result can be achieved by Class E controlled airspace to the ground, not just at nighttime like in this proposal, but for 24/24 instead of a daytime Class D. I would therefore propose to change the controlled airspace for KTME to Class E 24h instead of day Class D/Night Class E.

(p) IFR pilots could use Hobby.

(q) IFR pilots have the same obligation as VFR pilots to “See and Avoid” when in VMC.

(r) Aircraft diverting either north or south would put aircraft closer to the instrument approaches for KTME.

FAA response: The term corridor is generally used for the portion of I-10 that is underneath the Class B airspace; when the Class B airspace terminates, so does the corridor. It is important to note that the portion of the east/west I-10 corridor that lies inside the Class D does not underlie Class B. The VFR operation can still occur along I-10 either by circumnavigating the area approximately 14 flying miles or by establishing radio communications with the operating tower according to 14 CFR 91.126 or (if Class E airspace) 14 CFR 91.127. Since this area is not charted and the opening of TME was not widely known, the FAA has provided relief during this period by waiving the requirement to establish radio communications with the control tower during the airspace rulemaking process. 14 CFR 91.129 set minimum altitudes when operating in Class D airspace, unless otherwise required by the distance from cloud criteria, each pilot of a turbine-powered airplane and each pilot of a large airplane must climb to an altitude of 1,500 feet above the surface as rapidly as possible. The distance needed to climb to 1,500 feet does not make the option to cap the southern border at I-10 feasible. VFR aircraft departing to and from West Houston Airport could have a normal climb/descent profile by communicating with TME tower and receiving permission to transition through the airspace; this should not be approved if aircraft activity is in the same area. This would maintain or increase safety from today's environment.

This airspace action is not expected to cause any potentially significant environmental impacts, including no significant noise impacts. No extraordinary circumstances exists that warrant preparation of an environmental assessment.

When operating in VFR weather conditions, it is the pilot's responsibility to be vigilant so as to see and avoid other aircraft (14 CFR 91.113(a)). The Aeronautical Information Manual (AIM) recommends that for aircraft 8,000 feet AGL and below, extra vigilance be maintained and that monitoring an appropriate control frequency is to the VFR pilot's advantage to “get the picture of traffic in the area.” VFR pilots are to see and avoid other aircraft and to be extremely vigilant in congested VFR areas and Victor airways. Once again, an operating tower that meets the requirements of FAA Order 7400.2K, Chapter 17, is authorized Class D airspace. This proposal will have Class D airspace during tower operating hours and Class E surface area airspace during non-operating hours. The proposed altitude of 2,500 does not interfere with commercial traffic landing or departing IAH or HOU. The formal establishment of Class D airspace will allow for charting of the airspace dimensions and altitude which will provide notice to pilots to communicate or circumnavigate this area. The pilot will not be affected if the aircraft flies above 2,500 feet. The FAA acknowledges the inconvenience to the VFR pilot of flying at or above 2,500 feet and establishing radio communications with control towers. 14 CFR 91.126, Class G airspace; 14 CFR 91.127, Class E airspace require communication with the operating control tower (TME) unless otherwise authorized by ATC. The FAA does not agree that altitude compression will be constrained in this area since the floor of the Class B airspace is southeast of the proposed Class D airspace.

6. Comment: Three commenters stated that the proposed rulemaking (NPRM) should be to establish Class B Airspace in the Brookshire, TX area, instead of Class D and Class E Airspace. The commenters preferred to have the entire airspace controlled by the FAA. Some of the reasons cited in favor of Class B airspace were:

(a) A few miles north of the airport, the Class B airspace begins at 3,000 feet but the majority of the Class B area over the airport is 4,000 feet.

(b) Raising the top to meet the Class B further removes any confusion to transient traffic.

(c) TME, with its physical location near Houston's Corporate Energy Corridor and ample 6,610′ × 100′ runway, is attracting an ever growing number of larger and faster aircraft (turboprops and jets).

(d) Class D airspace tends to have less recreational flyers and experimental traffic that tend to increase immediate airport traffic congestion and noise with constant circling for touch and goes, etc.

FAA response: This airport and its location do not meet criteria for Class B airspace.

7. Comment: Supports Class E airspace only.

Five comments received supported the proposal of 2,500 feet if the airspace would be classified as Class E airspace.

FAA response: The requirement for VFR aircraft to establish radio communications is still in effect for Class G and/or Class E airspace; 14 CFR 91.126 and 14 CFR 91.127. Establishing the proposed Class D airspace will reduce the overall airspace dimensions. Approval to transit the area is still required; the benefit will be that all aircraft will have access to VFR charts and the airspace would be depicted.

14 CFR 91.127, Operating on or in the vicinity of an airport in Class E airspace, states:

(c) Communications with control towers. Unless otherwise authorized or required by ATC, no person may operate an aircraft to, from, through or on an airport having an operational control tower unless two-way radio communications are maintained between that aircraft and the control tower. Communications must be established prior to 4 nautical miles from the airport, up to and including 2,500 feet AGL. However, if the aircraft radio fails in flight, the pilot in command may operate that aircraft and land if weather conditions are at or above basic VFR weather minimums, visual contact with the tower is maintained, and a clearance to land is received. If the aircraft radio fails while in flight under IFR, the pilot must comply with 14 CFR 91.185.

8. Comment: No support for any change to the present airspace allocation.

Thirty-one comments received rejected the proposal entirely. An immediate return to the status quo was requested based on the long standing operations in this area. Additionally, many commenters cited the east/west I-10 corridor and the compression of the VFR navigable air space in the northeast affected area as a concern. The majority of comments provided for an alternate choice of a top altitude of 2,000 feet.

FAA response: The TME control tower opened October 1, 2014, and is operational; the status quo can no longer be maintained. The FAA is complying with all appropriate regulations.

9. Comment: Airspace compression in the northeast quadrant under Class B.

Twenty comments received concerned the compression of navigable airspace under Class B and Class D airspace around TME. Cited were safety concerns for VFR aircraft to squeeze into an already congested airspace. The concerns were departures of airports underneath the Class B, practice areas for student training, and the airspace compression along the east west I-10 corridor.

FAA response: The FAA has reviewed these concerns and agrees this is a compression of airspace with the establishment of Class D airspace. The proposal notes that 10 percent of the Class D footprint sits below the Class B shelf at 3,000 feet. The east/west I-10 corridor underlies Class B airspace; however, the portion of I-10 that does underlie the proposed Class D does not underlie Class B airspace. During the informal meetings this factor was taken into consideration and resulted in the proposed airspace being lowered from 2,700 feet to 2,500 feet to allow for more airspace. The compression to the northeast underlying Class B airspace is not considered the VFR corridor. The FAA believes this to have minimal impact on those aircraft that would have to fly around or over the proposed airspace.

The tower at Houston Executive Airport is established and the Class D and E airspace areas are being provided according to federal regulations. The Class D proposal to reduce the allowed footprint of the airspace provides for safe and efficient use of airspace. Class D enhances safety by setting VFR weather minima specified in 14 CFR 91.155 and through the communications and other requirements in 14 CFR 91.129 (and 14 CFR 91.127 for E airspace). Once Class D airspace is charted, the information is accessible to all pilots. The FAA understands the concerns of the commenters. However, the FAA chose the upper limit of the airspace at 2,500 feet to establish higher weather minima for VFR aircraft, transitioning above the airspace thus restricting access to VFR flights in the airspace while IFR operations are in progress. VFR aircraft transitioning at 2,000 feet through the airspace will still be allowed to do so as long as radio communications are established with the tower prior to the aircraft entering the Class D airspace, and no additional conflicts with other airspace users arise.

Class D and Class E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11A, airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A 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 establishes Class D airspace, and Class E surface area airspace extending upward from the surface to and including 2,500 feet MSL within a 4-mile radius of Houston Executive Airport, excluding that airspace west and northwest, to accommodate the establishment of an airport traffic control tower. This action reduces the allowed 4 nautical mile radius around Houston Executive Airport to assist the operators transitioning in and out of Sport Flyers Airport without the need of establishing radio communications with Houston Executive Airport. The proposed cutout also allows for accommodation for a private airstrip to the southwest of Houston Executive Airport. This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 also establishes Class E airspace extending upward from 700 feet or more above the surface of the earth within a 6.6-mile radius of Houston Executive Airport, to accommodate standard instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport.

Class D and E airspace areas are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, 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. 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 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 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 removes Class E surface area airspace at Alliance Municipal Airport, Alliance, NE; and modifies Class E airspace extending upward from 700 feet above the surface at Albion Municipal Airport, Albion, NE; Alliance Municipal Airport; Quinn Field, Gothenburg, NE; Brewster Field Airport, Holdrege, NE; Imperial Municipal Airport, Imperial, NE; Jim Kelly Field, Lexington, NE; and Millard Airport, Omaha, NE.

On May 3, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to remove Class E surface area airspace at Alliance Municipal Airport, Alliance, NE; and modify Class E airspace extending upward from 700 feet above the surface at Albion Municipal Airport, Albion, NE; Alliance Municipal Airport; Quinn Field, Gothenburg, NE; Brewster Field Airport, Holdrege, NE; Imperial Municipal Airport, Imperial, NE; Jim Kelly Field, Lexington, NE; and Millard Airport, Omaha, NE. (81 FR 26503) Docket No. FAA-2016-5388. 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 7400.11A, dated August 3, 2016, and effective September 15, 2016, 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 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A 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 removes Class E surface area airspace at Alliance Airport, Alliance, NE., as the airspace is no longer needed. This action also modifies Class E airspace extending upward from 700 feet above the surface at the following airports:

Within a 6.7-mile radius of Albion Municipal Airport, Albion, NE., with segments extending from the 6.7-mile radius to 9,7 miles southeast, and 6.7 miles northwest, of the airport;

Within a 7.2-mile radius of Alliance Municipal Airport, Alliance, NE;

Within a 7.3-mile radius of Quinn Field, Gothenburg, NE., with segments extending from the 7.3-mile radius of the airport to 11.1 miles northeast, and 7.3 miles southwest, of the airport;

Within a 6.5-mile radius of Brewster Field Airport, Holdrege, NE;

Within a 6.5-mile radius of Imperial Municipal Airport, Imperial, NE;

Within a 6.5-mile radius of Jim Kelly Field, Lexington, NE;

And within a 6.7-mile radius of Millard Airport, Omaha, NE.

Airspace reconfiguration is necessary due to the decommissioning of NDBs, cancellation of NDB approaches, and implementation of RNAV procedures at the above airports for the safety and management of the standard instrument approach procedures for IFR operations at the airports. The geographic coordinates for Quinn Field, Imperial Municipal Airport, and Jim Kelly Field are updated to be in concert with the FAAs aeronautical database.

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:

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 D and Class E airspace at Troy Municipal Airport at N. Kenneth Campbell Field, Troy, AL.

On June 21, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to amend Class D and Class E airspace extending upward from 700 feet above the surface at Troy Municipal Airport at N. Kenneth Campbell Field, formerly Troy Municipal Airport, Troy, AL, (81 FR 40213) Docket No. FAA-2014-0726, as new Standard Instrument Approach Procedures have been developed requiring airspace redesign. Additionally, Class E airspace designated as an extension to Class D surface area would be removed due to the decommissioning of the Troy VOR and cancellation of the VOR approaches. The geographic coordinates of the airport would be amended to coincide with the FAA's aeronautical database. 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 D and Class E airspace designations are published in paragraphs 5000, 6004 and 6005, respectively, of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A 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 amends Class E airspace extending upward from 700 feet above the surface within a 7.6-mile radius of Troy Municipal Airport at N. Kenneth Campbell Field and within 2-miles each side of a 070° bearing from the airport to 11.5-miles northeast of the airport, and within 2-miles each side of a 253° bearing from the airport to 11.3-miles southwest of the airport. Additionally, Class E airspace designated as an extension to Class D surface area is removed due to the decommissioning of the Troy VOR and cancellation of the VOR approaches. The geographic coordinates of the airport are amended to coincide with the FAAs aeronautical database. Also, this action recognizes the name change of Troy Municipal Airport at N. Kenneth Campbell Field (formerly Troy Municipal Airport).

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. 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 5-6.5a. 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:

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 at Ithaca Tompkins Regional Airport, Ithaca, NY.

In a review of the airspace for Ithaca Tompkins Regional Airport (formerly Tompkins County Airport), Ithaca, NY, the FAA found the airport name and geographic coordinates for the airport and the Ithaca VOR/DME, as published in FAA Order 7400.11A, Airspace Designations and Reporting Points, do not match the FAA's charting information for Class E Airspace Designated as an Extension to a Class D Surface Area.

Class E airspace designations are published in paragraph 6004 of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace designated as an extension at Ithaca Tompkins Regional Airport, Ithaca, NY. A minor adjustment to the geographic coordinates of the airport and the Ithaca VOR/DME is made to be in concert with the FAA's aeronautical database, as well as a name change from Tompkins County Airport to Ithaca Tompkins Regional Airport.

This is an administrative change and does not affect the boundaries, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

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. 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 will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will 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 5-6.5a. 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. Background

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device.

On December 11, 2013, RebiScan, Inc., submitted a request for classification of the Pediatric Vision Scanner under section 513(f)(2) of the FD&C Act.

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on June 8, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 886.1342.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a strabismus detection device will need to comply with the special controls named in this final order.

The device is assigned the generic name strabismus detection device, and it is identified as a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness.

Strabismus detection devices are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109, Prescription devices).

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the strabismus detection device they intend to market.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order refers to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding the quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows:

Pursuant to the authority of section 7034(o)(1) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016 (Div. K, Pub. L. 114-113), the United States of America, acting through the U.S. Agency for International Development, may issue certain loan guarantees applicable to sums borrowed by Ukraine (the “Borrower”), not exceeding an aggregate total of U.S. $1 billion in principal amount. Upon issuance, the loan guarantees shall ensure the Borrower's repayment of 100% of principal and interest due under such borrowings and the full faith and credit of the United States of America shall be pledged for the full payment and performance of such guarantee obligations.

This rulemaking document is not subject to rulemaking under 5 U.S.C. 553 or to regulatory review under Executive Order 12866 because it involves a foreign affairs function of the United States. The provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) do not apply.

The Louisiana Department of Transportation and Development requested a temporary deviation for the US 165 (Jackson Street) Drawbridge, across the Red River, mile 88.6, at Alexandria, Louisiana. It has a vertical clearance of 40.0 feet above normal pool in the closed-to-navigation position. The US 165 (Jackson Street) Drawbridge currently operates in accordance with 33 CFR 117.491(b).

This deviation period is from 6 a.m. to 6 p.m., each day, from September 26, 2016 to September 30, 2016 when the draw span will remain in the closed-to-navigation position. During this time the bridge owner will adjust the new pinion bearings that are essential to the continued safe operation of the drawbridge. Navigation on the waterway consists primarily of commercial tows and recreational watercraft and will not be significantly impacted. This temporary deviation has been coordinated with waterway users. No objections were received.

The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass this section of the Red River. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so the vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

I. Table of Abbreviations CFR Code of Federal Regulations 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

The U.S. Army Corps of Engineers and U.S. Department of Agriculture Wildlife Services notified the Coast Guard that they intend to conduct federally permitted removal operations of the Double-Crested Cormorant starting September 21, 2016. In response, on August 23, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Columbia River, Sand Island, WA 81 FR 57507. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this safety zone. During the comment period that ended September 12, 2016 we received no comments.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable because such delay would eliminate the safety zone's effectiveness and usefulness in preventing dangers to the boating public associated with the removal operations being conducted using firearms and live ammunition.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. Coast Guard Captains of the Port are granted authority to establish safety zones in 33 CFR 1.05-1(f) for safety purposes as described in 33 CFR part 165.

The Army Corps of Engineers and U.S. Department of Agriculture Wildlife Services will conduct a federally permitted removal operation of the Double-Crested Cormorant starting September 21, 2016. This operation will involve the use of firearms and live ammunition. The Captain of the Port Sector Columbia River (COTP) has determined that potential hazards associated with the removal operation will be a safety concern for anyone within a 500-yard radius of the small boat “Nessy,” while in the area encompassing these points: 46°15′45″ N., 123°59′39″ W.; 46°15′24″ N., 123°59′42″ W.; 46°13′32″ N., 123°57′18″ W.; 46°15′9″ N., 123°55′24″ W.; and 46°15′54″ N., 123°58′6″ W., and any associated support vessel(s). The safety zone is needed to protect personnel and vessels in the navigable waters within the safety zone during the removal operations.

As noted above, we received no comments on our NPRM published August 23, 2016. There are two changes in the regulatory text of this rule from the proposed rule in the NPRM. The change in paragraph (a) of the regulation is non-substantive and clarifies the language that describes the area that is designated a safety zone. The change in paragraph (c) of the regulation updates the language regarding assistance from state law enforcement to align with the statute cited.

This rule establishes a safety zone from September 21, 2016, through October 21, 2016. The safety zone will cover all navigable waters of the Columbia River within 500 yards of the small boat “Nessy,” and all involved associated support vessels being used by personnel during the removal operation, conducted in the area encompassed by these points: 46°15′45″ N., 123°59′39″ W.; 46°15′24″ N., 123°59′42″ W.; 46°13′32″ N., 123°57′18″ W.; 46°15′9″ N., 123°55′24″ W.; and 46°15′54″ N., 123°58′6″ W. The 500 yard radius area of the safety zone is intended to protect persons and vessels from the dangerous combined effects of live gunfire, unpredictable animal behavior, and a highly dynamic marine environment characterized by strong tides, river currents and wind. This safety zone will be enforced only when the small boat “Nessy,” and all involved associated support vessels, are conducting the removal operations, which will be three days a week for four weeks. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which would impact a small designated area of the Columbia River in the area encompassing these points: 46°15′45″ N., 123°59′39″ W.; 46°15′24″ N., 123°59′42″ W.; 46°13′32″ N., 123°57′18″ W.; 46°15′9″ N., 123°55′24″ W.; and 46°15′54″ N., 123°58′6″ W. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

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 no 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 the safety zone 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 (Public Law 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 safety zone lasting four weeks, for three days a week, that will prohibit entry within 500 yards of the small boat “Nessy” and all involved associated support vessels, while in the area encompassing these points: 46°15′45″ N., 123°59′39″ W.; 46°15′24″ N., 123°59′42″ W.; 46°13′32″ N., 123°57′18″ W.; 46°15′9″ N., 123°55′24″ W.; and 46°15′54″ N., 123°58′6″ W., while personnel are conducting the removal operations of the Double-Crested Cormorant. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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 165 as follows:

In a direct final rule published in the Federal Register on July 11, 2016, at 81 FR 44792, VA amended 38 Code of Federal Regulations (CFR) 38.603(b), giving the Under Secretary of Memorial Affairs (USMA), or his designee, authority to solicit gifts and donations, or approve the solicitation of gifts and donations from the public. VA published a companion substantially-identical proposed rule on the same date, at 81 FR 44827, to serve as a proposal for the revisions in the direct final rule in case adverse comments were received. The direct final rule and proposed rule each provided a 30-day comment period that ended on August 10, 2016. No adverse comments were received. Two comments that supported the rulemaking were received from the general public. VA is not making any changes to this rulemaking based on the comments.

Under the direct final rule procedures that were described in 81 FR 44827 and 81 FR 44792, the direct final rule became effective on September 9, 2016, because no adverse comments were received within the comment period. In a companion document in this issue of the Federal Register, VA is withdrawing the proposed rulemaking, RIN 2900-AP74, published at 81 FR 44827, as unnecessary.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on September 16, 2016, for publication.

I. Background

By statute, SIPs meeting the requirements of sections 110(a)(1) and (2) of the CAA are to be submitted by states within three years after promulgation of a new or revised NAAQS to provide for the implementation, maintenance, and enforcement of the new or revised NAAQS. EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Sections 110(a)(1) and (2) require states to address basic SIP elements such as requirements for monitoring, basic program requirements, and legal authority that are designed to assure attainment and maintenance of the newly established or revised NAAQS. More specifically, section 110(a)(1) provides the procedural and timing requirements for infrastructure SIPs. Section 110(a)(2) lists specific elements that states must meet for the infrastructure SIP requirements related to a newly established or revised NAAQS. The contents of an infrastructure SIP submission may vary depending upon the data and analytical tools available to the state, as well as the provisions already contained in the state's implementation plan at the time in which the state develops and submits the submission for a new or revised NAAQS.

Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and 110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct components, commonly referred to as “prongs,” that must be addressed in infrastructure SIP submissions. The first two prongs, which are codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (prong 1) and from interfering with maintenance of the NAAQS in another state (prong 2). EPA sometimes refers to these two prongs conjointly as the “good neighbor” provision of the CAA. The third and fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality in another state (prong 3) and from interfering with measures to protect visibility in another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs to include provisions ensuring compliance with sections 115 and 126 of the Act, relating to interstate and international pollution abatement.

In a notice of proposed rulemaking (NPRM) published on August 1, 2016 (81 FR 50409), EPA proposed to approve North Carolina's March 24, 2016, SIP submission and the portions of Alabama's December 9, 2015, SIP submission addressing interstate transport requirements for the 2010 NO2 NAAQS. The NPRM provides additional detail regarding the rationale for EPA's actions, including further discussion of the requirements for prongs 1 and 2. Comments on the proposed rulemaking were due on or before August 31, 2016. EPA received no adverse comments on the proposed actions. All other applicable infrastructure SIP requirements for Alabama and North Carolina for the 2010 1-hour NO2 NAAQS have been or will be addressed in separate rulemakings.

As described previously, EPA is approving North Carolina's March 24, 2016, SIP revision and the portions of Alabama's December 9, 2015, SIP revision addressing prongs 1 and 2 of CAA section 110(a)(2)(D)(i) for the 2010 1-hour NO2 NAAQS.

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

• Are not “significant regulatory actions” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

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

• are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of these actions must be filed in the United States Court of Appeals for the appropriate circuit by November 21, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of these actions for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. These actions may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

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-2015-0554 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 21, 2016. 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-2015-0554, 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 dock et, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of September 9, 2015 (80 FR 54257) (FRL-9933-26), 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 5F8368) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.242 be amended by establishing tolerances for residues of the fungicide thiabendazole in or on legume vegetables (succulent or dried), crop group 6 at 0.01 parts per million (ppm); foliage of legume vegetables, crop group 7, except pea, field, hay and vines at 0.01 ppm; pea, field, hay at 0.15 ppm; and pea, field, vines at 0.03 ppm. The petition also requested to amend the tolerances in 40 CFR 180.242 for residues of thiabendazole by removing the tolerances in or on bean, dry, seed at 0.1 ppm and soybean at 0.1 ppm. That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has modified levels at which the tolerances are being established by this document. The reason for these changes are explained in Unit IV.D.

In 2008, EPA established a rule codifying its determination that the use of thiabendazole as a seed treatment for dry pea using a maximum application rate of 0.075 pound of active ingredient per 100 pounds of seed did not require a tolerance because residues were below the Agency's threshold of regulation. (73 FR 1976 (Jan. 11, 2008); see 40 CFR 180.2010). The new tolerances for residues of thiabendazole on crop group 6 legume vegetable commodities, including dry pea, and on crop group 7, foliage of legume vegetable commodities, which includes vines and hay from the legume vegetables that the Agency is establishing make the existing threshold of regulation determination unnecessary. The new tolerances cover residues on these commodities resulting from new seed treatment uses that allow for higher application rates and thus residues associated uses covered by the threshold of regulation determination are covered by the new tolerances. As a result, the Agency is removing this determination from section 180.2010.

In response to a crisis exemption request and authorization of a specific exemption request filed under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on behalf of the North Carolina Department of Agriculture and Consumer Services for the emergency use of thiabendazole to control black rot disease on sweet potato, EPA is establishing pursuant to FFDCA section 408(l)(6) time-limited tolerances for the use of thiabendazole on sweet potato at 10 ppm with an expiration date of December 31, 2019.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of thiabendazole on sweet potato. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and the Agency decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although this time-limited tolerance expires and is revoked on December 31, 2019, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on sweet potato after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by the time-limited tolerance at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions whether thiabendazole meets FIFRA's registration requirements for use in or on sweet potato or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerances serves as a basis for registration of thiabendazole by a State for Special Local Needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than North Carolina to use this pesticide on sweet potato under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for thiabendazole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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 assessment 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 thiabendazole including exposure resulting from the tolerances, including the time-limited tolerance, established by this action. EPA's assessment of exposures and risks associated with thiabendazole 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 thyroid and liver (centrilobular hypertrophy) are the primary target organs of thiabendazole toxicity. Thiabendazole produced a treatment related increase in absolute and relative liver weights in both sexes in a chronic dog study. Other treatment related effects reported were histopathological changes in kidneys (hyperplasia of transitional epithelium, tubular degeneration) and spleen (congested and pigmented) in rats. Additional toxic effects observed in these studies included decreases in body weight and/or food consumption. The available database indicates that thiabendazole is not neurotoxic. In an acute neurotoxicity rat study (ACN), decreases in the Functional Observation Battery (FOB) (reduced body temperature in males, reduced rearing in females, and reduced locomotor activity in males and females at time of peak effect (approximately 3 hours post-dose)) were seen without morphological or histopathological effects on the brain. Thiabendazole was not neurotoxic in rats in a subchronic neurotoxicity study. In a 21-day dermal toxicity study in rats, no systemic or dermal effects were seen at the limit dose (1,000 milligram/kilogram/day (mg/kg/day)). In prenatal developmental toxicity studies in rats, rabbits, and mice and in the 2-generation reproduction study in rats, effects in the fetuses or neonates occurred at or above doses that caused maternal or parental toxicity.

In the adult animal, effects on the thyroid following thiabendazole exposure were observed at a dose lower than the neurotoxicity dose observed in the ACN. There are no thiabendazole data with which to determine whether this is also the case in the fetus/postnatal animal. Based on a weight of evidence (WOE) approach considering all the available hazard and exposure information for thiabendazole, the Agency concluded that a developmental thyroid toxicity study is required since there is clear evidence of thyroid toxicity in adult animals and thus a concern for potential toxicity during pregnancy, infancy and childhood. The developmental thyroid toxicity study will better address this concern than a developmental neurotoxicity study. In an immunotoxicity study, thiabendazole produced significant decreased spleen activity at the highest dose tested (5,000 ppm equivalent to 1,027 mg/kg/day) which also produced significant increased liver weight. The genetic toxicology studies on thiabendazole indicate that it is not genotoxic in in vivo and in vitro assays. Review of literature studies indicated that thiabendazole has weak aneugenic activity in both somatic and germinal cells. In a chronic rat study, thiabendazole induced thyroid tumors in males only. Thiabendazole did not induce tumors in mice. Thiabendazole has been classified by the Agency as “Likely to be carcinogenic at doses high enough to cause a disturbance of the thyroid hormonal balance but not likely to be carcinogenic at doses lower than those which could cause a disturbance of this hormonal balance.” This conclusion is based on the observation that that thiabendazole was not mutagenic, but above a threshold dose it interfered with thyroid-pituitary homeostasis leading to increased thyroid stimulating hormone (TSH) stimulation of the thyroid and thyroid tumors. The chronic NOAEL (10 mg/kg/day) for non-cancer risk assessment is not expected to alter thyroid hormone homeostasis nor result in thyroid tumor formation; therefore, the Agency has determined that quantification of risk using a non-linear approach (i.e., chronic population adjusted dose (cPAD)) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to thiabendazole.

Specific information on the studies received and the nature of the adverse effects caused by thiabendazole 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 titled “Thiabendazole: ID#16NC02—Section 18 Specific Emergency Exemption for the Postharvest Use of Thiabendazole on Sweet Potatoes in North Carolina” on page 32 in docket ID number EPA-HQ-OPP-2015-0554.

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

A summary of the toxicological endpoints for thiabendazole used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 25, 2014 (79 FR 57450) (FRL-9915-78).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to thiabendazole, EPA considered exposure under the petitioned-for tolerances and the tolerance being established in response to the Agency issuing a section 18 emergency exemption, as well as all existing thiabendazole tolerances in 40 CFR 180.242. EPA assessed dietary exposures from thiabendazole 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 thiabendazole. In estimating acute dietary exposure, EPA used 2003-2008 food consumption data 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 used a refined acute probabilistic dietary exposure assessment for thiabendazole using both anticipated residue estimates based on USDA Pesticide Data Program (PDP) monitoring data and percent crop treated (PCT) information for soybean and wheat and assumed 100 PCT for all other commodities.

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, EPA used a refined chronic probabilistic dietary exposure assessment for thiabendazole using both anticipated residue estimates based on USDA PDP monitoring data and PCT information for soybean and wheat and assumed 100 PCT for all other commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to thiabendazole. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

iv. Anticipated residue and percent crop treated (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.

For the acute assessment, the Agency estimated the PCT for existing uses as follows:

For the chronic assessment, the Agency estimated the PCT for existing uses as follows:

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

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which thiabendazole 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 thiabendazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of thiabendazole. 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 FQPA Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model GroundWater (PRZM-GW), the estimated drinking water concentrations (EDWCs) of thiabendazole for acute exposures are estimated to be 3.80 parts per billion (ppb) for surface water and 0.62 ppb for ground water, and for chronic exposures are estimated to be 0.47 ppb for surface 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 3.80 ppb was used to assess the contribution to drinking water.

For the chronic dietary risk assessment, the water concentration of value 0.47 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).

Thiabendazole is currently registered for use as antimicrobial ingredient in paint, sponges, carpet backing, canvas textiles, wallboard and ceiling tiles, polyurethane foam, plastics and rubber, paper, and coatings and filters used in HVAC systems. There are two antimicrobial exposure scenarios that were assessed for residential exposures which are expected to result in the highest exposures from these antimicrobial uses: Treated paint and impregnated sponges. The other antimicrobial uses of thiabendazole (carpet backing, canvas textiles, wallboard and ceiling tiles, polyurethane foam, plastics and rubber, paper, and coatings and filters used in HVAC systems) are not expected to cause exposure in residential settings because there is no direct contact to the treated articles, the vapor pressure of thiabendazole is very low, and the unlikelihood that the treated plastics and rubbers would be used in toys.

EPA assessed residential exposure to treated paint and impregnated sponges using the following assumptions: For treated paint, residential short-term dermal and inhalation exposure to residential handlers using brush/roller application and airless sprayer application; for the impregnated sponge use, short- and intermediate-term incidental oral exposure. Thiabendazole treated sponges are limited to 600 ppm thiabendazole on a sponge. Various residue amounts may be transferred from the sponge to food contact surfaces, such as countertops and utensils/glassware, and then to food and subsequently ingested. An assessment was conducted for incidental oral exposure assuming that 100% of the thiabendazole on a treated sponge is transferred to surfaces over 20 days and that each 20 days the user would use a new sponge (5% released per day). This assumption is considered conservative because (1) sponges will generally be used much longer than 20 days; (2) it is unlikely that 100% of the thiabendazole would be released from the sponge in such a short period; and (3) it is very unlikely that 100% of any released thiabendazole would be transferred to countertops because this assumption does not account any thiabendazole that is washed down the sink or that normally degrades.

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 thiabendazole to share a common mechanism of toxicity with any other substances, and thiabendazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thiabendazole 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. No evidence of increased quantitative or qualitative susceptibility was seen following in utero exposure to thiabendazole with rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. There is no evidence for neurotoxicity following oral exposures to thiabendazole. Thyroid toxicity was seen following subchronic and chronic exposures to adult rats in multiple studies. There is, however, no data regarding the potential effects of thiabendazole on thyroid homeostasis in the young animals. This lack of characterization creates uncertainty with regards to potential life stage sensitivities due to exposure to thiabendazole. Therefore, the Agency is requiring a developmental thyroid assay in rats with thiabendazole. This study will better address the concern for potential thyroid toxicity in the young.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF is retained at 10X in the form of a database uncertainty factor (UFDB). That decision is based on the following findings:

i. The toxicology database for thiabendazole is complete with the exception of a developmental thyroid toxicity study. Based on a WOE approach considering all the available hazard and exposure information for thiabendazole, the Agency concluded that a developmental thyroid toxicity study is required since there is clear evidence of thyroid toxicity in adult animals and thus a concern for potential toxicity during pregnancy, infancy and childhood. The developmental thyroid toxicity study will better address this concern than a developmental neurotoxicity study. Acceptable studies are available for developmental, reproduction, chronic, subchronic, subchronic neurotoxicity and immunotoxicity.

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

iii. The data submitted to the Agency, as well as those from published literature, demonstrate no increased susceptibility in rats, rabbits, or mice to in utero and/or early postnatal exposure to thiabendazole. In the prenatal developmental toxicity studies in rats, rabbits, and mice and in the 2-generations reproduction study in rats, developmental effects in the fetuses or neonates occurred at or above doses that caused maternal or parental toxicity. A developmental neurotoxicity study with thiabendazole was deemed not required by the Agency.

There is evidence of thyroid toxicity following subchronic and chronic exposures to rats characterized as histopathological changes in the thyroid in multiple studies in rats. Disruption of thyroid homeostasis is the initial, critical effect that may lead to adverse effects on the developing nervous system. Thus, as noted above, a developmental thyroid study is required.

iv. There are no residual uncertainties in the exposure database. The dietary risk assessment is conservative and will not underestimate dietary and/or non-dietary occupational exposure to thiabendazole. The acute and chronic dietary assessments conducted with the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) were refined analyses. The assessments utilized anticipated residues, default processing factors, and available percent crop treated data. The DEEM analysis also used Tier 1 drinking water estimates. For these reasons it can be concluded that the DEEM-FCID analysis does not underestimate risk from acute or chronic exposure to thiabendazole. Similarly, EPA does not believe that the non-dietary occupational exposures are underestimated because they are also based on conservative assumptions, including maximum application rates, and standard values for unit exposures and acreage treated/amount handled. These assessments will not underestimate the exposure and risks posed by thiabendazole.

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 thiabendazole at the 99.9th percentile of exposure will occupy 68% 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 thiabendazole from food and water will utilize 5.1% 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 thiabendazole is not expected.

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

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

Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in aggregate MOEs from the paint use of 2,000 or greater for all population subgroups and aggregate MOEs from the sponge use of 1,400 for children 1-2 years old and 7,000 for the general population. Because EPA's level of concern for thiabendazole is a MOE of 300 or below, these MOEs are not of concern.

4. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA is regulating chronic dietary risk, including cancer risk, with a chronic RfD that reflects a dose level below those levels at which thyroid hormone balance is impacted, which is protective of potential carcinogenic effects. Based on the lack of chronic risk, EPA concludes there is not a cancer risk from exposure to thiabendazole.

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

Acceptable enforcement analytical methods are available for thiabendazole and benzimidazole in plant commodities. Four spectrophotofluorometric methods for the determination of thiabendazole are published in the Pesticide Analytical Manual (PAM) Vol. II, and a high performance liquid chromatography (HPLC) method with fluorescence detection (FLD) for the determination of benzimidazole (free and conjugated) is identified in the U.S. EPA Index of Residue Analytical Methods under thiabendazole as Study No. 93020.

Another adequate analytical method, GRM040.05A, is also available for data collection and tolerance enforcement of residues of thiabendazole and benzimidazole (free and conjugated) in/on plant commodities. Method GRM040.05A, developed by Syngenta Crop Protection, LLC, is a high performance liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method used for data collection in crop matrices. HED has designated Method GRM040.05A as a new tolerance enforcement method.

Both methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [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 a MRL for thiabendazole on any of the commodities cited in this document.

A comment was submitted by the Center for Food Safety and was primarily concerned about EPA's consideration of the impacts of thiabendazole on the environment, pollinators, and endangered species. This comment is not relevant to the Agency's evaluation of safety of the thiabendazole tolerances under section 408 of the FFDCA, which requires the Agency to evaluate the potential harms to human health, not effects on the environment.

The petitioned-for tolerances did not include measurement of benzimidazole (free and conjugated) which is a residue of concern for regulatory purposes. Therefore, the petitioned-for tolerance for the vegetable, legume, group 6 at 0.01 ppm for thiabendazole only, is adjusted to 0.02 ppm to account for the combined residues of thiabendazole and benzimidazole (free and conjugated). Also, EPA concluded that the maximum levels of the combined residues of concern in/on the representative crop commodities of vegetable, foliage of legume, group 7 are within 5x, and that a crop group 7 tolerance level of 0.20 ppm is more appropriate than the petitioned-for separate tolerances for pea, field, hay; pea, field, vines; and vegetable, foliage of legume, group 7, except pea, field, hay and vines.

In this rulemaking, EPA is adding an expiration date of March 21, 2017 to the existing tolerances for bean, dry, seed at 0.1 ppm and soybean at 0.1 ppm. These tolerances were based on foliar uses of thiabendazole which are no longer registered and Syngenta requested that these tolerances be removed as part of the petition and notice of filing (NOF). The seed treatment uses on dry bean seed and soybean is now covered by the tolerance being established on vegetable, legume, group 6 at 0.02 ppm. This new tolerance is lower than some existing MRLs on these commodities in Europe and other countries.

In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures Agreement, EPA notified the WTO of the request to revise these tolerances on September 9, 2015, as WTO notification G/SPS/N/USA/2779. In this action, EPA is allowing the existing higher tolerances to remain in effect for 6 months following the publication of this rule in order to allow a reasonable interval for producers in exporting countries to adapt to the requirements of these modified tolerances. On March 21, 2017, those existing higher tolerances will expire, and the new reduced tolerances for vegetable, legume, group 6 at 0.02 ppm will remain to cover residues of thiabendazole on those commodities. Before that date, residues of thiabendazole on those commodities would be permitted up to the higher tolerance levels; after that date, residues of thiabendazole on vegetable, legume, group 6 will need to comply with the new lower tolerance levels. This reduction in tolerance is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods.

Therefore, tolerances are established for residues of thiabendazole in or on vegetable, foliage of legume, group 7 at 0.20 ppm and vegetable, legume, group 6 at 0.02 ppm. The Agency is also adding an expiration date of March 21, 2017 to the existing tolerances for bean, dry, seed at 0.1 ppm and soybean at 0.1 ppm. Residues of thiabendazole will be covered by these higher tolerances until the expiration date, after which time, they will need to comply with the lower tolerance being established today on the vegetable, legume, group 6 at 0.02 ppm. The tolerance for group 6 without a time limitation supersedes the existing section 18 time-limited tolerance for “pea, succulent shelled”; therefore, the Agency is removing that section 18 tolerance.

The Agency is also removing the threshold of regulation determination for thiabendazole from 180.2010 because it is no longer necessary. Lastly, this regulation additionally establishes a time-limited tolerances for residues of thiabendazole in or on sweet potato at 10 ppm.

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

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this 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:

A. Background

Agencies are authorized to procure transportation services either through the Federal Acquisition Regulation (FAR) by utilizing a contract, or via 49 U.S.C. 10721 (for rail transportation), 49 U.S.C. 13712 (for surface transportation), and/or 49 U.S.C. 15504 (for pipeline transportation) by utilizing rate tenders. It is critical that agencies ensure that transportation services received are properly charged and that the payment made is correct.

Toward that end, the Travel and Transportation Reform Act of 1998 (Pub. L. 105-264) established agency statutory requirements for prepayment audits of Federal agency and DoD transportation expenses. The Act also established GSA's statutory authority for audit oversight to protect the interests of the Government.

This final rule clarifies and strengthens agency and DoD compliance with regulations for transportation prepayment audits and postpayment audits. In addition, this final rule updates definitions in 41 CFR part 102-117, Transportation Management, as a result of the amendments to 41 CFR 102-118.

This final rule is the outcome of the first of a two phase review of FMR part 102-118, Transportation Payment and Audit, conducted by GSA and the Governmentwide Transportation Policy Council (GTPC). The GTPC is composed of representatives from civilian agencies and DoD and provides GSA with guidance in the planning and development of uniform transportation policies and procedures.

The first phase review focused on FMR part 102-118 Subparts A (General), D (Prepayment Audits of Transportation Services), and E (Postpayment Transportation Audits). The second phase review will focus on FMR part 102-118 Subpart A (General), as well as Subparts B (Ordering and Paying for Transportation and Transportation Services), C (Use of Government Billing Documents), and F (Claims and Appeals Procedures).

In the proposed rule published at 80 FR 59094 in the Federal Register, on October 1, 2015, GSA provided the public a 60-day comment period which ended on November 30, 2015. GSA received comments from the National Motor Freight Traffic Association, Inc. (NMFTA), and Relocation Management Worldwide Incorporated (RMW). This final rule reflects the following changes made as a result of some of these comments.

Comment: The definition in the proposed rule for declared value in FMR 102-117.25 and 102-118.35 contains reference to declared value and released value. However, NMFTA indicates that the “terms `declared value' and `released value' are neither synonymous nor recognized by the transportation industry. A carrier establishes released value provisions with the intent of the shipper agreeing to a lesser value for the cargo shipped in return for a lower rate for transportation. Declared value assigns a value to the cargo in order to authenticate loss and damage liability limitations on the cargo that was shipped. Furthermore, it is inequitable to define declared value as a price that could be `more' than the actual value of the cargo. In commercial practice, a transportation service provider (TSP) will not pay a loss or damage claim in excess of the actual value of the cargo transported.”

Response: GSA agrees with the recommendation and consequently has modified the definition declared value that is added to 41 CFR 102-117.25 so that it does not reference released value; included a definition for released value in 41 CFR 102-117.25; and has removed the definition released value from 41 CFR 102-118.

Comment: With regards to the definition claim, NMFTA indicates that in the transportation industry, the term claim is generally used in the context of claims for the payment of overcharges or claims for loss or damage. NMFTA recommends that any other terms for demands for payment by the TSP to the Government or amounts the TSP believes an agency owes them should not be included in this definition and would be better defined separately.

Response: GSA does not accept this recommendation. The definition of claim presented in this final rule is modeled after the definition of claim or debt found in 31 U.S.C. 3701(b)(1).

Comment: The Government Transportation Request (GTR) is defined, in part, as a Government document used to procure common carrier interstate transportation services. NMFTA indicates that as far as interstate motor carrier transportation is concerned, the term common carrier is no longer defined in 49 U.S.C. 13102. Former common carriers are now referred to as motor carriers. NFMTA suggests using the description motor carrier or TSP which is used elsewhere in these regulations. NFMTA also suggests that since the Government can procure intrastate transportation with a GTR, it does not make sense to include the word “interstate” in the final GTR definition.

Response: The term common carrier is used to define Government Transportation Request (GTR) in the Federal Travel Regulation (FTR). In response to the comment, GSA has revised the definition of GTR to clarify that the document is used to acquire passenger transportation.

Comment: Standard Carrier Alpha Code (SCAC) is defined, in part, as the unique four-letter code used to identify American-based motor transportation companies assigned by NMFTA. NMFTA indicates that the SCAC definition should be a two-to-four letter identification code assigned to all modes of transportation companies worldwide by the NMFTA.

Response: GSA accepts this comment and has modified the definition of SCAC to a unique code, typically two to four characters, used to identify transportation companies.

Comment: NFMTA indicates that the Standard Carrier Alpha Code (SCAC) is a proper noun and should be capitalized.

Response: GSA agrees with this comment and has made the appropriate changes.

Comment: When an agency notifies a TSP of any adjustment to a TSP bill, the notice must reference the TSP's Standard Carrier Alpha Code (SCAC) or other agency identifier for the carrier, such as the Department of Defense Activity Address Code (DoDAAC) number. NMFTA suggests deleting the reference to the DoDAAC as the DoDAAC is not used to identify TSPs. NMFTA indicates that the Defense Logistics Agency defines a DoDAAC as “. . . a six-character, alpha-numeric code that uniquely identifies a unit, activity, or organization within the DoDAAD [Department of Defense Activity Address Directory]. A unit, activity, or organization may have more than one DoDAAC for different authority codes or purposes. Each activity that requisitions, contracts for, receives, has custody of, issues, or ships DoD assets, or funds/pays bills for materials and/or services is identified by a six-position alphanumeric DoDAAC.”

Response: GSA accepts this suggestion and has deleted the DoDAAC reference.

Comment: The rule indicates that “the prepayment audit cannot be conducted by the same firm providing transportation services for the agency, such as a move manager.” Relocation Management Worldwide, Incorporated (RMW) suggests that the term move manager is an incorrect example of a TSP and should be removed. RMW indicates that a TSP, being a carrier, could have a conflict of interest auditing their own files, but a move manager does not have to be a TSP.

Response: GSA agrees that the language may be confusing and has modified § 102-118.275(c) to explain that a move manager may not have any affiliation with or financial interest in the transportation company providing the transportation services for which the prepayment audit is being conducted.

Comment: RMW asks if the rule's intent is to eliminate a move manager from being a prepayment auditor.

Response: GSA has modified the rule to clarify the role of a move manager in the prepayment process. GSA's intent is to clarify transportation payment and audit requirements for all agencies including DoD.

Comment: The rule indicates that agencies may choose to use a Third-Party Payment System or charge card company that includes prepayment audit functions, such as Syncada and Payport Express. RMW asks if GSA is allowed to promote specific companies and promote their own specific products in the Code of Federal Regulations.

Response: GSA agrees that the reference to Syncada may constitute an endorsement of a private enterprise and has removed the reference from the final rule. However, PayPort Express is a GSA Center for Transportation Management payment solution that is compliant with the rules established by GSA Transportation Audits Division. Being a GSA product, the acknowledgement of PayPort Express, or subsequent GSA payment solution, does not constitute the endorsement of a private enterprise.

Comment: The rule lists what information must be included in an agency's notice to a TSP when an agency is adjusting the TSP's bill. RMW points out that the list of required information excludes the reason for the adjustment and asks if this important element can be added to the list.

Response: The final rule accepts and incorporates the comment.

Comment: The rule indicates that the Administrator of General Services (GSA) has a congressionally mandated responsibility under 31 U.S.C. 3726 to perform oversight on transportation bills. The GSA Transportation Audits Division accomplishes this oversight by conducting postpayment audits of all agencies' transportation bills. RMW suggests that GSA should confirm and identify that the audits are actually performed by contracted auditing companies and not by GSA Transportation Audits.

Response: GSA does not accept this recommendation. Information regarding the GSA Transportation Audits Division procedures, including reviewing transportation invoices in conjunction with audit contracting companies, is provided on the Division's Postpayment Audit homepage (www.gsa.gov/portal/content/100056).

Comment: RMW requests that GSA identify what safeguards are in place to prevent contracted auditing companies from providing both the prepayment and postpayment audit of the same bill.

Response: GSA has determined that this topic is outside the intended scope of this rule. GSA Transportation Audits Division's Dispute Resolution Branch (http://www.gsa.gov/portal/content/100753) provides oversight and quality control evaluation of GSA audit contractors and ensures integrity in all audit processes.

Comment: This rule indicates that the GSA Transportation Audits Division does not charge agencies a fee for conducting the transportation postpayment audit and the expenses for such audits are financed from overpayments collected from the TSP's bills previously paid by the agency and similar type of refunds. Since the GSA Transportation Audits Division or contracted auditing companies do not receive funding unless they find errors in TSP billings, RMW asks how this is not a conflict of interest?

Response: GSA has determined that this topic is outside the intended scope of this rule. The funding mechanism identified in this rule is established by statute, 31 U.S.C. 3726 Payment for transportation.

Comment: If the GSA Transportation Audits Division is overseeing the prepay audit to ensure it is being done properly, RMW asks who is overseeing the GSA Transportation Audits Division to determine if the prepay oversight and the postpayment audit are being done properly?

Response: While GSA has determined that this topic is outside the intended scope of this rule, the GSA Office of the Inspector General and the management of the Federal Acquisition Service (FAS) provide such oversight of the GSA Transportation Audits Division.

This final rule:

• Revises the definitions for “Agency”, “Bill of lading” (BOL), “Government bill of lading” (GBL), “Transportation document” (TD), and “Transportation Service Provider” (TSP), removes the definition “Release/declared value”, and adds the definitions “Declared value” and “Released value” in FMR part 102-117; and revises the definitions “Agency”, “Bill of lading” (BOL), “Document reference number”, “Government bill of lading” (GBL), “Government transportation request”, Offset”, “Overcharge”, “Postpayment audit”, “Rate authority”, “Reparation”, “Standard Carrier Alpha Code” (SCAC), “Statement of difference”, “Supplemental bill”, “Transportation document (TD)”, and “Transportation Service provider” (TSP), removes the terms “Agency claim”, “Released value”, “Transportation service”, “Transportation service provider claim”, and “Virtual GBL (VGBL)”, and adds the terms “Claim” and “Transportation” in FMR part 102-118 to ensure consistency.

• Strengthens agency requirements and responsibilities for transportation prepayment audits and transportation postpayment audit, submission requirements to the GSA Transportation Audits Division, and the required information on all transportation documentation.

• Updates and clarifies GSA Transportation Audits Division roles and responsibilities.

Executive Orders (E.O.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action, and therefore, will not be subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

These revisions are not substantive, and therefore, this rule would not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The proposed rule is also exempt from the Administrative Procedure Act per 5 U.S.C. 553(a)(2), because it applies to agency management or personnel.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. Chapter 35).

This rule is also exempt from Congressional review prescribed under 5 U.S.C. 801 since it relates to agency management or personnel.

For the reasons set forth in the preamble, GSA amends 41 CFR parts 102-117 and 102-118 as follows:

This is a synopsis of the Commission's Report and Order, MB Docket No. 16-182, adopted September 1, 2016, and released September 2, 2016. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW., Washington, DC 20554. The full text is also available online at http://apps.fcc.gov/ecfs/. This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. The Commission will send a copy of the Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

Regulations governing the Atlantic bluefish fishery are found in 50 CFR 648.160 through 648.167. The regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through Florida. The process to set the annual commercial quota and the percent allocated to each state are described in § 648.162.

The final rule implementing Amendment 1 to the Bluefish Fishery Management Plan published in the Federal Register on July 26, 2000 (65 FR 45844), and provided a mechanism for transferring bluefish quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the Administrator, Greater Atlantic Region, NMFS (Regional Administrator), can request approval of a transfer of bluefish commercial quota under § 648.162(e)(1)(i) through (iii). The Regional Administrator must first approve any such transfer based on the criteria in § 648.162(e).

Both states have requested the transfer of 40,000 lb (18,144 kg) of bluefish commercial quota from New Jersey to New York. Both states have certified that the transfer meets all pertinent state requirements. This quota transfer was requested by the New York to ensure that its 2016 quota would not be exceeded. The Regional Administrator has approved this quota transfer based on his determination that the criteria set forth in § 648.162(e)(1)(i) through (iii) have been met. The revised bluefish quotas for calendar year 2016 are: New Jersey, 683,739 lb (310,139 kg); and New York, 727,289 lb (329,893 kg). These quota adjustments revise the quotas specified in the final rule implementing the 2016-2018 Atlantic Bluefish Specifications published on August 4, 2016 (81 FR 51370), and reflect all subsequent commercial bluefish quota transfers completed to date. For information of previous transfers for fishing year 2016, visit: http://go.usa.gov/xZT8H.

This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.

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

The 2016 total allowable catch (TAC) of shortraker rockfish in the Central Regulatory Area of the GOA by vessels not participating in the catcher/processor cooperative fishery in the Rockfish Program is 181 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2016 TAC of shortraker rockfish in the Central Regulatory Area of the GOA by vessels not participating in the catcher/processor cooperative fishery in the Rockfish Program has been reached. Therefore, NMFS is requiring that shortraker rockfish in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b). This closure does not apply to vessels participating in the catcher/processor cooperative fishery in the Rockfish Program.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of shortraker rockfish in the Central Regulatory Area of the GOA for vessels not participating in the catcher/processor cooperative fishery in the Rockfish Program. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 16, 2016.

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

This action is required by §§ 679.20 and 679.21 and is exempt from review under Executive Order 12866.