Federal Register Vol. 80, No.189,

The NRC published a final rule in the Federal Register on September 9, 2015 (80 FR 54223), that amended its regulations to better adhere to the OFR's guidance for formatting authority citations. In addition, the final rule corrected typographical errors and made other non-substantive corrections to the NRC's authority citations. The final rule inadvertently included incorrect punctuation and spacing in the authority citations for parts 54, 95, and 110 of Title 10 of the Code of Federal Regulations (10 CFR).

The final rule also included an incorrect reference in the authority citation for 10 CFR part 73. In a final rule published on May 20, 2013 (78 FR 29520), the NRC moved the advance notification provisions to governors of affected states for shipments of spent nuclear fuel through their affected states from 10 CFR 73.37(f) to 10 CFR 73.37(b)(2). There was no conforming change made to the authority citation for 10 CFR part 73, which still referenced 10 CFR 73.37(f). In a final rule published on November 10, 2014 (79 FR 66598), the NRC corrected this reference by changing it to 10 CFR 73.37(b)(2) in the authority citation for 10 CFR part 73. The September 9, 2015, final rule inadvertently reversed the previous correction. This document restores the authority citation for 10 CFR part 73 to reference 10 CFR 73.37(b)(2) rather than 10 CFR 73.37(f).

In addition, the final rule did not include a reference to Section 229 of the Atomic Energy Act (42 U.S.C. 2278a) in the authority citation for 10 CFR part 73. In a final rule published on October 14, 2009, the NRC amended its regulations to authorize the imposition of federal criminal penalties on those who introduce weapons or explosives without authorization into specified classes of facilities subject to NRC regulatory authority (74 FR 52667). The authority for this amendment derived from Section 654 of the Energy Policy Act of 2005 (EPAct), codified at 42 U.S.C. 2278a. The September 9, 2015, final rule converted citations to the EPAct to their corresponding citations in the United States Code, but did not include a reference to 42 U.S.C. 2278a. This document adds this reference to the 10 CFR part 73 authority citation.

Lastly, the final rule did not include a reference to Section 170H of the Atomic Energy Act (42 U.S.C. 2210h) in the authority citations for 10 CFR parts 20 and 32. In a final rule published on November 8, 2006, the NRC amended its regulations to implement the National Source Tracking System for certain sealed sources as required by Section 651(d) of the EPAct (71 FR 65686). In the 2006 final rule, the authority citations for 10 CFR parts 20 and 32 both referenced the entirety of the EPAct as authority, but these references were changed to specific references to Section 651(e) of the EPAct in a final rule published on October 1, 2007 (72 FR 55864), effectively removing the references to Section 651(d). The September 9, 2015, final rule did not restore this reference (codified at 42 U.S.C. 2210h). This document adds this reference to the authority citations for 10 CFR parts 20 and 32.

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(B), the NRC finds good cause to waive notice and opportunity for comment on the amendments because it will have no substantive impact and is of a minor and administrative nature. Specifically, these amendments are to correct punctuation and spacing and incorrect and omitted references in authority citations. These amendments do not require action by any person or entity regulated by the NRC. Also, the final rule does not change the substantive responsibilities of any person or entity regulated by the NRC. Furthermore, for these reasons, the NRC finds, pursuant to 5 U.S.C. 553(d)(3), that good cause exists to make this rule effective upon publication of this document.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 20, 32, 54, 73, 95, and 110.

Section 412 of the FAA Modernization and Reform Act of 2012 (Pub. L. 112-95) 1 (the Act) required the FAA to conduct rulemaking “[T]o require each air carrier operating under part 121 of title 14, Code of Federal Regulations, to post on the Internet Web site of the air carrier the maximum dimensions of a child safety seat that can be used on each aircraft operated by the air carrier to enable passengers to determine which child safety seats can be used on those aircraft.” 2 This rulemaking is promulgated under the scope of the authority in section 412 of the Act.

In addition to the authority found in the Act, the FAA has authority under Title 49 of the United States Code (49 U.S.C.) to issue rules on aviation safety. Section 106 of Subtitle I 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 consistent with the authority described in 49 U.S.C. 106(f), which establishes the authority of the Administrator to promulgate regulations and rules and 49 U.S.C. 44701(a)(5), which requires the Administrator to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security.

Existing regulations regarding the use of a child restraint system (CRS) on airplanes operating under part 121 are found in 14 CFR 121.311. In accordance with § 121.311, no certificate holder 3 conducting operations under part 121 may prohibit a child from using an approved CRS when the child's caregiver 4 purchases a ticket for the child.

The FAA strongly encourages the use of an FAA-approved CRS on aircraft.5 However, in a small number of cases, an approved CRS may not fit in a particular airplane seat because the CRS exceeds the dimensions of the airplane seat. Accordingly, the FAA has issued guidance to facilitate the use of a CRS on airplanes in situations when a caregiver purchased a ticket for the child but the approved CRS that the caregiver wishes to use does not fit in a particular seat on the airplane.6 7 Although the FAA has provided guidance to air carriers regarding how to accommodate a CRS, this rulemaking would give caregivers additional information on whether an FAA-approved CRS will fit on the airplane on which they expect to travel.

This rule requires air carriers operating under 14 CFR part 121 that have Web sites to post on their Web sites information regarding airplane seat dimensions. The FAA notes, however, that this rule does not require an air carrier that does not have a Web site to establish a Web site to satisfy the information disclosure requirements of this final rule.

Specifically, affected air carriers must post the width of the narrowest and widest passenger seats in each class of service for each airplane make, model and series operated in passenger-carrying operations. By requiring air carriers to make this information available, the agency expects caregivers to have more information about whether a specific CRS can be used on the airplane on which they expect to travel.

The FAA emphasizes that this rule includes an information disclosure requirement only. It does not create any new operational requirements for air carriers or flight attendants; it does not change any existing provisions regarding the use of a CRS on board airplanes or existing regulations regarding passengers under the age of 2 traveling on board airplanes with or without the use of a CRS; and, it does not require an air carrier to identify the specific airplane that it will use on a given flight.

This final rulemaking is minimal cost and is estimated to be $372,600 over a ten-year period ($271,800 present value).

Existing requirements regarding CRS use in part 121 operations are found in 14 CFR 121.311. Section 121.311(c)(2) generally states that no air carrier may prohibit a child, if requested by the child's caregiver, from occupying a CRS furnished by the child's caregiver provided that the following conditions are satisfied: The child holds a ticket for an approved seat or a seat is made available by the air carrier for the child's use; the child is accompanied by a caregiver; and, the CRS is appropriately labeled and secured. (Certificate holders are encouraged to allow the use of an empty seat to accommodate a CRS; however, they are not required to allow non-ticketed children to occupy empty passenger seats, even if the child uses a CRS.)

Under § 121.311(c)(3), however, air carriers may determine the most appropriate passenger seat location for a CRS based on safe operating practices. In assessing the most appropriate location for a CRS, an air carrier must consider a number of factors. For example, the CRS must be installed in a forward-facing airplane seat in accordance with the provisions of § 121.311. This includes placing the CRS in the appropriate forward or aft-facing direction as indicated on the label for the size of the child. A window seat is the preferred location; however, other locations may be acceptable, provided the CRS does not block the egress of any passenger, including the child's caregiver, to the aisle used to evacuate the airplane.

The FAA encourages the use of an approved CRS on airplanes and has committed to educate and inform passengers, air carriers and crewmembers regarding CRS use on airplanes in order to increase their use on airplanes. Accordingly, the FAA provides information on its Web site for caregivers traveling with children on the use of a CRS on airplanes. The public information and guidance material are intended to be useful to caregivers in support of the agency's commitment regarding CRS use. For example, the FAA has previously addressed the issue of “CRS fit” in airplane seats on the FAA Web site by informing caregivers that a CRS with a maximum width of 16 inches should fit in most airplane seats.8

Additionally, on November 3, 2005, the FAA published Advisory Circular (AC) 120-87, Use of Child Restraint Systems on Aircraft, to serve as a resource during development, implementation, and revision of an air carrier's standard operating procedures and training programs regarding CRS use. The FAA has since published two amended versions of the AC. AC 120-87A was published on December 1, 2006 and AC 120-87B was published on September 17, 2010. The AC provides information on placement of a CRS on airplanes that may be considered by air carriers as they develop policies regarding seat locations for CRS use on a specific airplane. The AC also explains how placement of a CRS in an aisle seat or in a seat forward or aft of an emergency exit row may affect egress during an evacuation. Further, the AC emphasizes the carrier's discretion in identifying the most appropriate forward-facing passenger seat location for a CRS but explains that prohibiting the use of a CRS by a ticketed child, when there are seats where the CRS could be used safely, is not consistent with § 121.311. The FAA will publish updated AC 120-87C with this final rule to address the seat dimension disclosure requirements of this final rule.

The FAA also published Information for Operators (InFO) 11007, Regulatory Requirements Regarding Accommodation of Child Restraint Systems—Update, to clarify regulations regarding CRS accommodation and to provide information for a CRS with a detachable base. As with AC 120-87, InFO 11007 provides examples of CRS design variations and lists possible solutions for accommodation. For example, a CRS with a base that is too wide to fit properly in a seat with rigid armrests could be moved to a seat with moveable armrests that can be raised to accommodate the CRS, and an aft-facing CRS that cannot be installed properly, because of minimal pitch (distance between rows of seats), can be moved to a bulkhead seat or a seat in a row with additional pitch. The FAA will publish an updated InFO so that it remains consistent with the requirements of this final rule.

Section 412 of the FAA Modernization and Reform Act of 2012 (Pub. L. 112-95) (the Act) required the FAA to conduct rulemaking “[T]o require each air carrier operating under part 121 of title 14, Code of Federal Regulations, to post on the Internet Web site of the air carrier the maximum dimensions of a child safety seat that can be used on each aircraft operated by the air carrier to enable passengers to determine which child safety seats can be used on those aircraft.” To fulfill the requirements of the Act, the FAA proposed to require air carriers operating under part 121 to make available on their Web sites the width of the widest passenger seat in each class of service for each make, model and series of airplane used in passenger-carrying operations (79 FR 18212, April 1, 2014). The agency intended the proposed revisions to part 121 to provide greater information to caregivers to help them determine whether a particular CRS will fit in an airplane seat. This proposal would not have affected existing regulations regarding the use of a CRS on board airplanes or a passenger under the age of 2 traveling onboard airplanes with or without the use of a CRS. The NPRM provided a public comment period of 90 days, which ended on June 30, 2014.

The FAA received ten comments. Commenters included three individuals, Airlines for America (A4A), the American Automobile Association (AAA), the Association of Flight Attendants (AFA), Baby B'Air, Consumers Union, the National Transportation Safety Board (NTSB) and Spirit Airlines (Spirit). All of the commenters generally supported the proposed changes; however, some suggested changes, as addressed in the section of the document entitled, “Discussion of Public Comments and Final Rule.”

The FAA received comments on the following general issue areas related to the proposal:

• Disclosure of the width of the narrowest seat in addition to the proposal to disclose the width of the widest seat in each class of service;

• Disclosure of the width of the narrowest seat in lieu of the proposal to disclose the width of the widest seat in each class of service;

• Disclosure of seat pitch in addition to the proposal to disclose seat width;

• Airplane equipment changes that result in seat measurements different from the measurements relied upon for a seat previously purchased;

• Definition of “seat width”; and

• Commonality of seat dimensions (within the same class of service) among an air carrier's airplanes within the same make, model and series.

Several commenters addressed issues outside of the scope of this rulemaking. These issues included discussion of a requirement for all passengers including infants to be properly secured in their own seats with an approved safety restraint.

This rulemaking satisfies the rulemaking requirement of section 412 of the Act by making more information available to allow caregivers to make a determination regarding CRS fit prior to a flight. In the NPRM, the agency proposed to require air carriers conducting passenger operations under part 121 to disclose on their Web sites the width of the widest passenger seat in each class of service for each airplane make, model and series within the air carrier's fleet. The proposal was limited in its applicability to part 121 air carriers conducting passenger-carrying operations because all-cargo operations have generally been excluded from part 121 requirements pertaining to passengers.9 See 14 CFR 121.583. The agency notes that the proposed information disclosure requirement would supplement existing regulations that allow the use of an approved CRS and FAA guidance to caregivers regarding CRS fit in airplane seats.

The final rule differs from the proposal in two respects. First, whereas the proposal required disclosure of only the widest seat in each class of service, the final rule requires disclosure of both the widest and the narrowest seats in each class of service. Second, the final rule clarifies the measurement of seat width. The agency addresses these modifications in more detail in the discussions entitled “Disclosure of width of the widest and narrowest seats in each class of service” and “Definition of seat width” respectively.

Although section 412 of the Act refers to the maximum dimensions of child safety seats that can be used on each aircraft the operator uses, the FAA proposed an alternate approach in the NPRM in order to implement the statute's goal to enable a passenger to determine which CRS can be used on an airplane. The FAA does not believe that it is practical for each air carrier to provide the maximum dimensions of one or many CRSs the carrier does not possess or to which the carrier does not have ready access. In contrast, air carriers have ready access to the airplanes they operate and information regarding those aircraft.

Therefore, the agency proposed to require air carriers to provide seat dimension data to fulfill the intent of the statutory requirement for rulemaking. Seat dimension data provides information equivalent to CRS dimension data that can be used to assist caregivers in making a determination as to whether a CRS will fit in a passenger seat on the airplane on which they expect to travel.

The agency did not receive any comments objecting to the proposal to provide seat dimension information and A4A specifically supported it. Accordingly, in the final rule, the FAA has maintained the NPRM approach to providing seat dimension information.

In the NPRM, the agency proposed to amend § 121.311 by adding a requirement for air carriers to disclose seat dimension information for each class of service for each airplane make, model and series that a certificate holder uses in passenger-carrying operations.

Class of service—Spirit noted that while it has only one class of service, within that class it offers wider seats at a higher price. Spirit's concern is that publishing the dimensions of these higher-priced seats could mislead passengers, causing them to believe that the higher priced seats are available without paying an additional fee.

The FAA appreciates Spirit's comments but has determined that class of service is the most relevant break point for information disclosure as it remains the prevailing concept used to distinguish seat products, including the seat size variations and amenities that are associated with those products. It has also been the agency's longstanding policy that CRS accommodation need only be made within the same class of service as the ticket holder's class of service in order to comply with § 121.311(c)(2). See AC 120-87. Thus, disclosure of seat dimension information for each class of service correlates to the existing air carrier obligations for CRS accommodation. The DOT defines “class of service” to mean seating in the same cabin class such as First, Business, or Economy class, or in the same seating zone if the carrier has more than one seating product in the same cabin such as Economy and Premium Economy class.

The agency recognizes, however, that there may be seat product concepts that are analogous to the distinction in classes of service for purposes of CRS accommodation and that they may be relevant to the assessment of CRS accommodation. The agency will address these analogous seat product concepts and their relevance to CRS accommodation in revised CRS guidance material published with this final rule (AC 120-87C).

The purpose of this final rule is to facilitate CRS use on airplanes through disclosure of seat dimensions. Consistent with this goal, the agency encourages air carriers to provide any additional information to their customers that would further facilitate CRS use on airplanes.

Airplane substitutions and airplane equipment (passenger seats)—Two commenters (NTSB and AAA) expressed concern about airplane substitutions and the absence of a requirement for air carriers to disclose the make, model and series for each flight. NTSB noted that the NPRM does not address situations in which an air carrier makes an airplane substitution and the substitution airplane has different types of seats with measurements that differ from the measurements relied upon for a seat previously purchased for the intended use of a CRS. AAA suggested that the FAA should require air carriers to provide a list of potential planes used for particular routes, as this could provide consumers with information more relevant and useful in planning travel. Consumers Union recommended that air carriers should identify the airplane that will be used for each segment of a flight, whether that segment is operated by the air carrier with which the consumer is dealing directly, or by some other air carrier with which the first air carrier has a code-sharing or other partnership arrangement.

In related comments, A4A and Spirit disagreed with FAA's information about the commonality of seat dimensions among an air carrier's airplanes of the same make, model and series. A4A stated, “The widths of the widest and narrowest passenger seats may vary within a given aircraft series and operated by the same carrier depending on the particular model of seats installed on the aircraft.” Similarly, Spirit commented that its 29 Airbus A319-100 airplanes are equipped with different seat models that differ in width.

The information disclosure requirements in this final rule balance the directive to facilitate CRS use and the necessary operational flexibility that air carriers must have to substitute airplanes as they determine appropriate. Currently, there is no requirement for air carriers to disclose in advance of a flight, the specific airplane that will be used for that flight, and such a requirement is outside of the scope of this rulemaking. Without such a requirement, additional seat information disclosure requirements applicable to each specific airplane in an air carrier's fleet would not further facilitate CRS use.

While the agency agrees with comments indicating that not every airplane of the same make, model and series used by a particular air carrier may be equipped with the same seat model, and that some may differ in size, after further review of airplanes used by affected air carriers, the FAA determined that in many cases, there is commonality in seat dimensions for airplanes of the same make, model, and series operated by an air carrier. Therefore, this final rule leverages the commonality that does exist among aircraft seats to provide caregivers with the most helpful information regarding CRS fit.

Additionally, in the example cited by Spirit where there may be varying models of seats on a particular make, model and series of aircraft, Spirit would still only have to post two measurements. In Spirit's example, the make is Airbus, the model is 319 and the series is 100. If, hypothetically, there were three or four different models of seats with varying widths on their entire A-319-100 fleet, in order to comply with the requirements of this final rule, Spirit would only have to post the dimensions of the narrowest seat and the widest seat in each class of service for their entire fleet of A-319-100s.

Accordingly, the final rule retains the proposed requirement to disclose seat information for each class of service for each airplane make, model, and series operated by the air carrier in passenger carrying operations.

In the NPRM, the agency proposed to require air carriers to disclose the width of the widest passenger seat in each class of service because width is the predominant limiting seat dimension for CRS use on airplanes. Also, if a caregiver knew the width dimension of the widest seat for a particular class of service on an airplane, and if the CRS the caregiver intended to use on the flight fits within that dimension, then the caregiver would be able to expect that at least one seat in the class of service for which the caregiver and child were ticketed would accommodate the CRS.

The agency also sought comment on alternative proposals pertaining to the disclosure of seat width. Specifically, the agency asked whether disclosure of only the narrowest seat in each class of service or disclosure of both narrowest seat and the widest seat in each class of service would be more effective in facilitating CRS use.

Two commenters (an individual and Spirit) recommended that the FAA modify the proposal by requiring air carriers to disclose the dimensions of the narrowest seat in each class of service rather than the widest. An individual commenter noted that if a CRS will fit in the narrowest seat in a particular class of service, it will fit in all seats in that class. Spirit offered a similar argument and added that disclosure of the widest seat in each class of service would lead to passenger confusion about the availability of the widest seats.

Four commenters (A4A, AFA, NTSB and Consumers Union) recommended modifying the proposal by requiring air carriers to disclose the widths of both the narrowest and widest seats in each class of service because such a requirement would further the goal of providing the most useful information to caregivers.

A4A suggested that disclosure of dimensions of only the widest seat on an aircraft could lead caregivers to mistakenly assume that their CRS will fit in their reserved seat if it is smaller than the dimensions of the widest seat available, and that such misunderstandings could lead to airplane boarding delays. A4A also noted that disclosure of only the widest seat could discourage caregivers from using a CRS based on concern that they may not be assigned to that widest seat. Further, A4A commented that provision of the widths of both the narrowest and widest seats in each class of service provides caregivers a more complete picture of the dimensions of the entire seat class, enabling them to make more informed decisions pertaining to CRS use.

AFA commented that requiring disclosure of both dimensions would more effectively achieve the statutory intent of facilitating CRS use. AFA did not support disclosure of only the widest seat in each class of service.

NTSB commented that providing the width for both the narrowest and widest seats in each class of service for seats in which a CRS could be installed would give caregivers more useful information. NTSB explained that this additional information could enable the caregiver to work with the air carrier to determine the most suitable seat assignment. NTSB also commented that providing the dimensions of the narrowest seats could help CRS manufacturers to develop or identify a CRS that can fit in any air carrier seat, thereby assisting caregivers in procuring a CRS suitable for air travel.

Consumers Union generally supports a requirement to disclose seat dimension information, but added that a better approach would be to require disclosure of all the dimensions of all available seats on an airplane to enable the consumer to select an appropriate seat from all available seats.

While the FAA recognizes that other seat dimensions may limit CRS fit on some occasions, seat width remains the predominant limiting dimension for CRS use in an airplane seat and thus remains the focus of this rulemaking. However, upon further consideration of the proposal and review of comments, the FAA agrees with comments regarding the benefits of disclosure of the width of both the narrowest and widest seat in each class of service for each airplane make, model and series. Disclosure of the widths of both the narrowest and widest seats in each class of service would be more effective in achieving the statutory intent of facilitating CRS use. Thus, the final rule requires each air carrier to make available on its Web site the width of both the narrowest and widest passenger seats in each class of service, for each airplane make, model, and series used in passenger-carrying operations under part 121. Disclosure of the width of the narrowest and widest seats in each class of service will enable caregivers to better determine if the CRS they provide for their child will fit in the airplane on which they expect to travel and thus will encourage more widespread use of a CRS in air transportation.

Finally, NTSB commented that “[I]nformation should only be provided for seats in which an approved CRS would be allowed to be installed.” The NTSB noted that CRS use is typically not permitted in exit rows and aisle seats so as not to affect emergency egress. The FAA agrees with the intent of the NTSB comment and recognizes the importance of information about potential limitations on CRS use.

Some air carriers currently publish information regarding regulatory restrictions or approved operating procedures that limit CRS use in specific airplane locations (e.g. exit rows, seats that are not forward facing, aisle seats).10 In the updated guidance material published with this final rule (AC 120-87C), the agency encourages all air carriers to provide passengers with such information. The agency emphasizes that under § 121.311(c) and as further explained in AC 120-87C (and previous editions of this AC), the FAA permits air carriers to determine the most appropriate passenger seat location for a CRS, consistent with safe operating practices. Although some limits on CRS location may be aircraft-specific and thus consistently applied across aircraft of the same make, model and series, in other cases, the air carrier determination regarding CRS location may be operation-specific. Air carriers must retain the operational flexibility to adjust their procedures regarding CRS placement and make real-time determinations regarding CRS placement as necessary to comply with safe operating practices. Thus given the necessity for air carriers to retain the flexibility to determine appropriate seat locations for CRS use, the suggested modification to the requirement for seat information on the air carrier's Web site would not further facilitate CRS use and result in an unnecessary burden.

A4A stated that the NPRM did not define seat width and suggests that the FAA include a definition of “seat width” in the final rule to avoid confusion. A4A recommended that seat width should be measured as the distance between the inside of the seat arm rests.

Although the NPRM preamble identified seat width as the distance between arm rests, to ensure clarity, the amendment to § 121.311 will include a definition of seat width applicable to seat dimension disclosure requirements. Consistent with the A4A comment and the NPRM preamble, the definition will specify that seat width is the distance between the inside of the seat arm rests.

In the NPRM, the FAA considered requiring disclosure of seat pitch (distance between rows of seats); however the agency determined that the predominant passenger seat dimension that limits CRS use is the width of the passenger seat.

Three commenters—NTSB, Consumers Union and AAA—recommended that the FAA require disclosure of seat pitch in addition to seat width, as seat pitch may be the limiting dimension in situations involving a rear-facing CRS. The agency acknowledges that in some circumstances, seat pitch can affect the use of a CRS that must be used in an aft-facing position, but using pitch to determine CRS fit is complex and minimally effective without additional detail.

Air carriers may be able to provide the distance between rows of passenger seats or “pitch” and some air carriers currently do so. However, as stated in the NPRM, a rear-facing CRS does not have an equivalent measurement to “pitch” as it does to “width.” In order to be installed properly, an aft-facing CRS must be installed in an aircraft seat on an angle. An aft-facing CRS has an installed level indicator (typically a moving ball or needle that must stay between two lines) that indicates when the CRS is properly oriented in the airplane seat. Therefore, although seat pitch can affect whether there is enough room to properly use an aft-facing CRS, it is only part of the triangular equation with several variables which makes it difficult for seat pitch data to provide meaningful information to a caregiver. (The agency notes that one way to accommodate an aft-facing CRS that does not fit in a row because of seat pitch, is for the air carrier to move the CRS to a seat in a bulkhead row where pitch is not typically an issue.)

Based on the foregoing and consistent with the proposal, the final rule does not require air carriers to provide information regarding seat pitch.

Consistent with the requirement for rulemaking in section 412 of the Act, the agency proposed to require air carriers that have Web sites to disclose on those Web sites certain seat dimension data. The final rule includes this disclosure requirement.

In the NPRM, the FAA noted that a number of air carriers currently conducting passenger-carrying operations already provide seat dimension information on their Web sites. For example, some air carriers currently provide both the pitch and width for the passenger seats in each class of service. The agency expects, however, that the information disclosure proposed in the NPRM and included in this final rule will increase the instances in which caregivers are able to assess whether a CRS will fit on an airplane make, model, and series on which they expect to travel.

Air carriers may use existing information pages on their Web sites that already provide information regarding airplane cabin interior dimensions and CRSs to list the width of the widest and narrowest seats for each class of service on each airplane make, model, and series in their fleets.

The only time an air carrier would need to update its Web site after initial implementation would be when a new airplane make, model, or series is introduced to the air carrier's fleet, or when the air carrier replaces the widest or narrowest seats installed on an existing airplane make, model, or series with wider or narrower seats.

Consumers Union stated that it is insufficient to require seat dimension information to be disclosed only on air carrier Web sites and recommended making such information available “[E]verywhere a consumer might purchase a ticket or change a flight.” While the FAA appreciates the intent behind this comment, this rule is promulgated under the authority of section 412 of the Act, which requires the FAA to initiate rulemaking to require air carriers conducting part 121 operations to make certain information available on those air carriers' Web sites. Therefore, as proposed, the final rule will require seat information disclosure on the air carrier's Web site only.

Three commenters—Consumers Union, NTSB, and AFA—suggested that the ultimate goal should be to mandate that all passengers including infants be properly secured in their own seats with approved safety restraints. Consumers Union added that as an interim step, air carriers should facilitate and encourage CRS use by offering seats at no cost or a drastically reduced cost for infants and toddlers under the age of two.

The FAA appreciates the intent of these comments and strongly encourages the use of a CRS on airplanes through multiple outreach efforts. However, this comment recommends changes to current passenger seating requirements that are outside of the scope of the information disclosure NPRM that preceded this final rule.

The FAA proposed a conforming change to 14 CFR 121.583 to make clear that the requirement applies in passenger-carrying operations only. The FAA did not receive any comments on this proposed conforming change and has included it in the final rule.

The FAA submitted a request for Office of Management and Budget (OMB) approval for the information collection activities in this final rule. OMB has approved the information collection and assigned OMB control number 2120-0760. Accordingly, the FAA is updating the table in § 11.201(b) to display this control number.

The FAA recognizes that different operators will need different lengths of time to comply with this regulation due to variations in information technology systems, variations in currently published data, and the range of numbers of airplane make, model and series in each operator's fleet. In the NPRM, the FAA proposed an effective date of 150 days after the date of publication of the final rule in the Federal Register and proposed to require compliance on the effective date.

While the FAA did not receive any comments on the proposed effective and compliance dates, further review of this issue led the FAA to conclude that the effective date of the final rule should be 30 days after publication. Accordingly, the final rule will be effective 30 days after publication in the Federal Register, and compliance will be 150 days after publication of the final rule.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Agreements Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this rule.

Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it to be included in the preamble if a full regulatory evaluation of the cost and benefits is not prepared. Such a determination has been made for this rule. The reasoning for this determination follows.

The FAA estimates that children under the age of two represent one percent of all commercial passengers.11 When travelling by air, a caregiver for a child under the age of two may choose either to fly with the child seated in the caregiver's lap (at no additional fee for the caregiver), or to purchase a separate ticket for the child, thus allowing the child to be secured in his or her own seat, with or without the use of a CRS. The agency does not have the exact count of passengers younger than two or whether those passengers arrived at their destinations sitting in the lap of a caregiver or secured in a separate airplane seat.

For child safety purposes, the FAA encourages (but does not require) caregivers to purchase a separate ticket for each child under the age of two so that the child can be securely restrained in a CRS. The FAA does not require the use of CRS for children under the age of two based on the FAA's analysis which shows that when caregivers are forced to purchase airline seats for children under age 2, the additional cost of an airline ticket will motivate some families to drive to their destinations instead of to fly. As background, section 522 of Public Law 103-305, required the Secretary of Transportation to study the impact of mandating the use of CRSs for children under 2 years old on scheduled air carriers. The Secretary submitted a report of this study to Congress in 1995. The report estimated that if a child restraint rule were imposed, approximately five infant lives would be saved aboard aircraft, and two major injuries and four minor injuries would be avoided over a 10-year period. The report also cautioned that this improvement would be offset by additional highway fatalities for airline passengers who chose to drive rather than purchase a seat for children under age 2. Even if infant fares were only 25 percent of full fare, the report estimated that there would be diversion to cars and thus a net increase in fatalities over a 10-year period.

The concern expressed in the 1995 report on mandating the use of CRSs for children under 2 years old, was that mandating CRSs (which require a passenger seat) could increase airline travel costs to families with children under age 2 enough to cause a significant number to travel by automobile instead of by airplane. In turn, this would expose the entire family to the higher risks of automobile travel and associated highway fatalities and injuries.12 The FAA updated this report in December, 2011, and confirmed its conclusion.13

Currently, air carriers are not required to disclose seat dimension information on their Web sites. It is believed that some caregivers choose not to travel with a CRS due to concern that the seat will not fit the particular equipment being flown. Congress directed the FAA to conduct rulemaking “[T]o require each air carrier operating under part 121, to post on the Internet Web site of the air carrier the maximum dimensions of a child safety seat that can be used to enable passengers to determine which child safety seats can be used on those aircraft.” See Public Law 112-95. Once implemented, this rule would require each part 121 air carrier that conducts passenger-carrying operations to post seat dimension information to their Web site (air carriers that do not have Web sites are excluded from this rule). This rule will benefit caregivers by making seat dimension information accessible, which in turn will allow them to determine if a particular CRS may fit in a seat of an aircraft. A caregiver may be inclined to purchase a separate ticket for a child under age 2 if the caregiver can reasonably expect that the child under age 2 can be secured in a CRS during flight.

The FAA considered several alternatives for determining the type of seat dimension information to be posted on air carrier Web sites.

One alternative required the width of each seat in each class of service for each individual airplane operated by an air carrier be posted on its Web site. While this alternative would provide the most precise information to caregivers, the FAA believes that maintaining this much detail to be unnecessarily onerous for the air carriers because multiple seats of the same width can be found within each class of service. Further, in order for this information to be useful, there can be no change in a flight's equipment from the time a ticket is purchased to the time of the flight's departure.

Another alternative required air carriers to publish only one dimension — that of the narrowest seat across an air carrier's entire fleet. This alternative, however, would only allow a caregiver to determine if there may be a possibility of a particular CRS fitting a particular airline seat on a particular flight. The FAA believes that providing the dimension of the narrowest seat only across an entire fleet would not facilitate CRS use because a caregiver with a CRS larger than the narrowest seat may be discouraged from using a CRS, even though there may be wider seats available that could accommodate one. Therefore this approach would not meet the intent of Congress when it mandated disclosure of seat dimensions.

After considering the alternatives, the FAA decided that the information to be posted on air carrier Web sites should provide caregivers with data to facilitate CRS use but should not be overly burdensome for the air carriers. Based on these criteria and comments to the proposed rule, the final rule requires an air carrier to post on its Web site the width of the narrowest and widest seats for each make, model, and series of aircraft in each class of service in the air carrier's fleet. This level of detail is reasonable given that most air carriers already disclose other airplane-related dimensions on their Web sites, including dimensions for overhead bins, space underneath seats, maximum size of carry-on luggage, and maximum size for pet carriers. Because of the level of detail air carriers are already providing, the FAA believes the requirements of this rule to be a minimal impact to those part 121 air carriers conducting passenger-carrying operations.

In the proposed rule air carriers were required to provide only the dimension of the widest seat for each make, model, and series of aircraft. The FAA received no comments on the cost-benefit methodology and estimates.

To account for the inclusion of providing the narrowest seat dimension in addition to that of the widest, the costs of the final rule exceed those estimated for the proposed rule. The cost increase is a result of the additional workload required by staff to gather and post to an air carrier's Web site the dimension of the narrowest seat dimension for each make, model, and series of aircraft operated by an air carrier, in addition to that of the widest. The FAA assumes that this activity does not impact the time estimated in the NPRM for management to verify that a carrier's Web site has been updated satisfactorily. Thus, adding the narrowest seat dimension to a carrier's Web site for the final rule increases present value costs beyond those of the NPRM by $6,500 for the low case, and $7,600 for the high case (in 2013 dollars).

The FAA reports there to be 81 part 121 air carriers; 14 however, only 58 of the 81 air carriers are impacted by this rule. Excluded from this rule's analysis are 21 cargo carriers; 1 air carrier that has ceased operations and filed for bankruptcy; and 1 air carrier that does not have an Internet Web site (air carriers that do not have Web sites do not need to comply with this rule).

To determine the cost of this rule, hours are estimated for each occupational job series 15 required to complete the task. The estimated hours are then multiplied by the United States Department of Labor Bureau of Labor Statistics (BLS) fully-burdened hourly wage rate for the corresponding occupational job series. Thus, the rule's total cost equals hours worked multiplied by hourly wages, summed across all part 121 air carriers affected by this rule. Further detail on the estimation of costs is provided below.

As the basis of costs for this rulemaking, the FAA used assumptions regarding job skills and labor hours from the regulatory analysis 16 for the DOT's “Enhancing Airline Passenger Protections” 17 rule. One provision of the DOT's rule required an air carrier to post on its Web site a tarmac delay plan and a customer commitment plan. The FAA believes that the skills and labor hours necessary to post seat dimension information to an air carrier's Web site are similar to those estimated for posting a tarmac delay plan and customer commitment plan. During the first year of the DOT's implementation of the “Enhancing Airline Passenger Protections” rule, it was estimated that it would take a computer programmer and a supervisor/manager a total of 8 hours to post the customer commitment plan and tarmac delay plan to an air carrier's Web site. The FAA is using the DOT estimate as the basis for the time required for air carriers to comply with the seat dimension disclosure rule.

To show a range of costs for the 58 air carriers affected by this rulemaking, the FAA first estimated a low and high case of hours worked by staff (database and systems administrators) and management.18 The estimated hours consist of two components: Base hours and variable hours. The base hour component is applicable to both staff and management. For staff, base hours represent the time it takes to identify the tasks required to post seat dimension disclosure information to an air carrier's Web site. For management, base hours represent the time expended verifying that Web sites are in compliance with this rulemaking. Base hours are assumed to be equal across all air carriers.

The variable hour component is only applicable to the staff labor group. It accounts for the incremental labor required to make Web sites compliant to this rule for air carriers operating a fleet of multiple aircraft makes, models, and series, versus those that may operate only one make, model, and series of aircraft. Thus, the variable hour component increases for each make, model and series of aircraft operated by an individual carrier. Total costs of this rule are calculated by multiplying the hours expended for each of the labor groups by their respective hourly compensation, which are then summed across all carriers.

Following is a more detailed description of the estimated hours and costs by labor group. It is important to note that even for the high case, this final rule is still expected to be minimal cost.

The FAA expects the time required for an air carrier to revise its Web site to include seat dimension information is most labor intensive during the first year of the rule's implementation. The estimated hours to comply with this rule include work performed by the staff and management labor groups.

Staff Hours: As in the NPRM, the low and high case base hour component for staff labor totals 8 and 16 hours, respectively, for each of the 58 air carriers. However, the variable hour component used to estimate costs for the NPRM is doubled for the final rule, going from 0.5 hours per make, model and series of aircraft in an air carrier's fleet to 1.0 hour. The doubling of this component is based on the FAA decision to require air carriers to disclose on their Web sites the width of the narrowest seat for each make, model, and series of aircraft, in addition to the requirement for air carriers to disclose the width of the widest seat. The variable hour component does not vary between the low and high case.

As an example, an air carrier operating 3 make, model, and series of aircraft will expend 11 hours complying with this rule for the low case and 19 hours for the high case.19 In the low case, the 11 hours is made up of 8 base hours plus 3 variable hours (1 variable hour for each of the 3 make, model, and series of aircraft). In the high case, base hours are doubled to 16 hours, while the variable hours remain the same as in the low case at 3 hours, for a total of 19 hours.

Management Hours: Management oversight is required by each air carrier to verify that the update to the Web site has been completed satisfactorily. As in the NPRM, it is assumed that each of the 58 Web sites will require two hours of management review time to verify accuracy of data. This assumption is the same for both the low and high case.

For years 2 through 10, the FAA determined that less time is required, relative to year 1, to maintain the accuracy of seat dimension information posted to an air carrier's Web site. During this timeframe, it is established that air carriers with Web sites have already posted seat dimension information; thus air carriers may only need to revise the data periodically.

Staff Hours: For the low case, we use the same NPRM estimate of four staff hours annually for posting revised data. For the high case, staff hours worked are double that of the low case, for a total of 8 staff hours per year.

Management Hours: Management hours required for oversight during years 2 through 10 is estimated to be one hour per year. This estimate is the same for both the low and high case.

The total cost for air carriers to comply with this rule is the sum of compensation paid 20 to staff and management for hours worked. The FAA determined, based on BLS job titles,21 that staff work is performed by Database and System Administrators and Network Architects (BLS Job Series 15-1140), and manager oversight is performed by Computer and Information Systems Managers (BLS Job Series 11-3021).

Since BLS reports average labor costs for scheduled air carriers independently of those for nonscheduled air carriers, estimated hours worked are tallied individually as well. Of the 58 Web sites in this analysis, 42 are for air carriers engaged in scheduled operations while the remaining 16 Web sites are for air carriers engaged in nonscheduled operations. The following table shows the fully-burdened rates used to estimate costs for the scheduled and nonscheduled air carrier groups.

The FAA has determined that notice of, and opportunity for, prior public comment on these special conditions are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplane.

In addition, the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On February 3, 2014, the Boeing Company applied for an amendment to Type Certificate no. A20WE to allow installation of single-occupant, oblique-angled (side-facing) seats with airbag devices in Boeing Model 747-8 airplanes.

Boeing requested special conditions to allow installation of oblique business-class passenger seats in the Boeing Model 747-8 airplane. The seating configuration Boeing proposes in Certification Plan no. 15090, “Installation of Business Class Zodiac Seats and Furniture for 747-8 TRX RC076,” consists of Zodiac Cirrus III model side-facing, pod-style, business-class seats (with surrounding shells and front-row furniture) installed at an angle of up to 30 degrees to the airplane longitudinal centerline. These seats will include inflatable restraint (airbag) systems for occupant restraint and injury protection.

The Model 747-8 airplane, a derivative of the Model 747-400 airplane, is a bi-level, wide-body airplane powered by four wing-mounted General Electric GEnx-2B engines. The airplane will have a maximum seating capacity of 605 passengers and two crew members, and a maximum takeoff weight of 987,000 pounds.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 747-8 airplane meets the applicable provisions of the regulations listed in Type Certificate no. A20WE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type certification basis.” The regulations listed in Type Certificate no. A20WE are as follows:

14 CFR part 25, Amendments 25-1 through 25-120, with exceptions permitted by § 21.101. In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for Boeing Model 747-8 airplanes because of a novel or unusual design feature, special conditions are prescribed under § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 747-8 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The business-class seating configuration Boeing proposes is novel or unusual due to the seat installation at 30 degrees to the airplane centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration also is beyond the limits of current acceptable equivalent-level-of-safety findings.

Ongoing research is progressing to establish acceptable limits. Until those limits become available, the FAA proposes a set of interim limits based on the current literature available, current National Highway Traffic Safety Administration (NHTSA) regulations, and preliminary test data from the research program.

The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785. The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.

Amendment 25-15 to part 25, dated October 24, 1967, introduced the subject of side-facing seats, and a requirement that each occupant in a side-facing seat must be protected from head injury by a safety belt and a cushioned rest that will support the arms, shoulders, head, and spine.

Subsequently, Amendment 25-20, dated April 23, 1969, clarified the definition of side-facing seats to require that each occupant of a seat, positioned at more than an 18-degree angle to the vertical plane of the airplane longitudinal centerline, must be protected from head injury by a safety belt and an energy-absorbing rest that will support the arms, shoulders, head, and spine; or by a safety belt and shoulder harness that will prevent the head from contacting any injurious object. The FAA concluded that an 18-degree angle would provide an adequate level of safety based on tests that were performed at that time, and thus adopted that standard.

Part 25 was amended June 16, 1988, by Amendment 25-64, to revise the emergency-landing conditions that must be considered in the design of the airplane. Amendment 25-64 revised the static-load conditions in 14 CFR 25.561, and added the new § 25.562 that requires dynamic testing for all seats approved for occupancy during takeoff and landing. The intent of Amendment 25-64 is to provide an improved level of safety for occupants on transport-category airplanes. Because most seating is forward-facing on transport-category airplanes, the pass/fail criteria developed in Amendment 25-64 focused primarily on these seats. As a result, the FAA issued Policy Memorandums ANM-03-115-30 and PS-ANM-100-2000-00123 to provide the additional guidance necessary to demonstrate the level of safety required by the regulations for side-facing seats.

To reflect current research findings, the FAA developed a methodology to address all fully side-facing seats (i.e., seats positioned in the airplane with the occupant facing 90 degrees to the vertical plane of the airplane centerline), and has documented those requirements in a set of new special conditions. The FAA issued Policy Statement PS-ANM-25-03-R1 to define revised injury criteria associated with neck and leg injuries.

The proposed Model 747-8, a Transaero Airlines business-class seat installation, is novel such that the current Model 747-8 airplane certification basis does not adequately address protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. Therefore, The Boeing Company's proposed configuration will require new special conditions.

These special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions are applicable to the Boeing Model 747-8 airplanes configured with the business-class seating defined in Boeing Certification Plan. Should Boeing apply at a later date for a change to the type certificates to include another model incorporating the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would apply to the other model as well.

This action affects only certain novel or unusual design features on one model airplane. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Boeing Model 747-8 airplane.

In addition to the requirements of § 25.562:

1. Head Injury Criteria.

Compliance with § 25.562(c)(5) is required, except that, if the anthropomorphic test device (ATD) has no apparent contact with the seat/structure but has contact with an airbag, a head-injury criterion (HIC) unlimited score in excess of 1000 is acceptable, provided the HIC15 score (calculated in accordance with 49 CFR 571.208) for that contact is less than 700.

2. Body-to-Wall/Furnishing Contact.

If a seat is installed aft of structure (e.g., an interior wall or furnishing) that does not provide a homogenous contact surface for the expected range of occupants and yaw angles, then additional analysis and/or test(s) may be required to demonstrate that the injury criteria are met for the area that an occupant could contact. For example, if different yaw angles could result in different airbag performance, then additional analysis or separate test(s) may be necessary to evaluate performance.

3. Neck Injury Criteria.

The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.

a. The Nij (calculated in accordance with 49 CFR 571.208) must be below 1.0, where Nij =Fz/Fzc + My/Myc, and Nij critical values are:

b. In addition, peak Fz must be below 937 lb in tension and 899 lb in compression.

c. Rotation of the head about its vertical axis, relative to the torso, is limited to 105 degrees in either direction from forward-facing.

d. The neck must not impact any surface that would produce concentrated loading on the neck.

4. Spine and Torso Injury Criteria

a. The shoulders must remain aligned with the hips throughout the impact sequence, or support for the upper torso must be provided to prevent forward or lateral flailing beyond 45 degrees from the vertical during significant spinal loading. Alternatively, the lumbar spine tension (Fz) cannot exceed 1200 lb.

b. Significant concentrated loading on the occupant's spine, in the area between the pelvis and shoulders during impact, including rebound, is not acceptable. During this type of contact, the interval for any rearward (X-direction) acceleration exceeding 20g must be less than 3 milliseconds as measured by the thoracic instrumentation specified in 49 CFR part 572, subpart E, filtered in accordance with SAE International (SAE) J211-1.

c. Occupant must not interact with the armrest or other seat components in any manner significantly different than would be expected for a forward-facing seat installation.

5. Longitudinal test(s), conducted to measure the injury criteria above, must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609. The test(s) must be conducted with an undeformed floor, at the most-critical yaw case(s) for injury, and with all lateral structural supports (armrests/walls) installed.

If inflatable airbag systems are installed on single-place side-facing seats, the airbag systems must meet Special Conditions no. 25-589-SC.

The FAA has determined that notice of, and opportunity for, prior public comment on these special conditions are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplane.

In addition, the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On October 14, 2010, Embraer S.A. applied for an amendment to Type Certificate No. TC00062IB to include the new Embraer Model EMB-545 airplane. These special conditions allow installation of inflatable lap belts for head-injury protection on certain seats in Embraer Model EMB-545 airplanes.

The Embraer Model EMB-545 airplane is a derivative of the Model EMB-550 airplane currently approved under Type Certificate No. TC00062IB. As compared to the Model EMB-550, the Model EMB-545 fuselage is one meter shorter; the section ahead of the wing is 0.65 meters shorter; and the section aft of the wing is 0.40 meters shorter.

The fuselage length difference is in the pressurized section. The Model EMB-545 airplane is designed for an eight-passenger configuration and a maximum of nine passengers (including lavatory seat). Like the Model EMB-550, the Model EMB-545 airplane primary structure is aluminum. Materials other than aluminum will be used in areas with unique structural requirements. Advanced composites will be largely employed on the high-lift devices (two flaps), spoilers (three panels), and control surfaces (aileron). A winglet will be attached to each wing tip to further increase airplane aerodynamic efficiency. The empennage will be a swept T-tail composed of advanced composite material with metallic attachment fittings. The rudder and elevators also will be composed of composite material.

Two Honeywell HTF7500-E medium-bypass-ratio turbofan engines, mounted on aft-fuselage pylons, will power the Model EMB-545 airplane. Each engine will produce approximately 6,540 lbs. of thrust for normal takeoff. However, because the Model EMB-545 is smaller and lighter, software will regulate the thrust. The primary flight-control systems (elevators, ailerons, rudder, and multi-function spoilers) will be electronically controlled and powered by electrohydraulic servoactuators using digital fly-by-wire (FBW) technology. The FBW flight controls will receive commands directly from the cockpit dual sidesticks and conventional rudder pedals.

Occupants must be protected from head injury, as required by § 25.785, either by eliminating any injurious object within the striking radius of the head, or by installing padding. Traditionally, this has required either a setback of 35 inches from any bulkhead or other rigid interior feature or, where not practical, the installation of specified types of padding. The relative effectiveness of these established means of injury protection was not quantified. With the adoption of Amendment 25-64 to part 25, specifically § 25.562, a new standard was created that quantifies required head-injury protection.

Each seat-type design approved for crew or passenger occupancy during takeoff and landing, as required by § 25.562, must successfully complete dynamic tests or be demonstrated by rational analysis based on dynamic tests of a similar type seat. In particular, the regulations require that persons not suffer serious head injury under the conditions specified in the tests, and that protection must be provided, or the seat be designed, so that head impact does not exceed a HIC value of 1,000 units. While the test conditions described for HIC are detailed and specific, it is the intent of the requirement that an adequate level of head-injury protection be provided for passengers in a severe crash.

Because §§ 25.562 and 25.785 and associated guidance do not adequately address seats with inflatable lap belts, the FAA recognizes that appropriate pass/fail criteria need to be developed that fully address the safety concerns specific to occupants of these seats.

Under the provisions of 14 CFR 21.101, Embraer must show that the Model EMB-545 airplane meets the applicable provisions of the regulations listed in Type Certificate No. TC00062IB, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in Type Certificate No. TC00062IB are as follows:

14 CFR part 25, effective February 1, 1965, including Amendments 25-1 through 25-129, in their entirety. In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for Embraer Model EMB-545 airplanes because of a novel or unusual design feature, special conditions are prescribed under § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, Embraer Model EMB-545 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

Embraer Model EMB-545 airplanes will incorporate the following novel or unusual design feature: seats with inflatable lap belts.

The inflatable lap belt has two potential advantages over other means of head-impact protection. First, it can provide significantly greater protection than would be expected with energy-absorbing pads, and second, it can provide essentially equivalent protection for occupants of all stature. These are significant advantages from a safety standpoint, because such devices will likely provide a level of safety that exceeds the minimum standards of part 25. Conversely, inflatable lap belts in general are active systems and must be relied upon to activate properly when needed, as opposed to an energy-absorbing pad or upper torso restraint that is passive and always available. Therefore, the potential advantages must be balanced against this and other potential disadvantages to develop standards for this design feature.

The FAA has considered the installation of inflatable lap belts to have two primary safety concerns: first, that they perform properly under foreseeable operating conditions; and second, that they do not perform in a manner or at such times as would constitute a hazard to the airplane or occupants. This latter point has the potential to be the more rigorous of the requirements, owing to the active nature of the system.

The inflatable lap belt will rely on electronic sensors for signaling, and will employ an automatic inflation mechanism for activation, so that it is available when needed. These same devices could be susceptible to inadvertent activation, causing deployment in a potentially unsafe manner. The consequences of such deployment must be considered in establishing the reliability of the system. Embraer must substantiate that the effects of an inadvertent deployment in flight are either not a hazard to the airplane, or that such deployment is an extremely improbable occurrence (less than 10−9 per flight hour). The effect of an inadvertent deployment on a passenger or crewmember that might be positioned close to the inflatable lap belt should also be considered. The person could be either standing or sitting. A minimum reliability level will have to be established for this case, depending upon the consequences, even if the effect on the airplane is negligible.

The potential for an inadvertent deployment could be increased as a result of conditions in service. The installation must take into account wear and tear so that the likelihood of an inadvertent deployment is not increased to an unacceptable level. In this context, an appropriate inspection interval and self-test capability are considered necessary. Other outside influences are lightning and high-intensity radiated fields (HIRF). Existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are applicable. For compliance with those conditions, if inadvertent deployment could cause a hazard to the airplane, the inflatable lap belt is considered a critical system; if inadvertent deployment could cause injuries to persons, the inflatable lap belt should be considered an essential system. Finally, the inflatable lap-belt installation should be protected from the effects of fire, so that an additional hazard is not created by, for example, a rupture of a pyrotechnic squib.

To function as an effective safety system, the inflatable lap belt must function properly and must not introduce any additional hazards to occupants as a result of its functioning. The inflatable lap belt differs variously from traditional occupant-protection systems and requires special conditions to ensure adequate performance.

Because the inflatable lap belt is essentially a single-use device, it could potentially deploy under crash conditions that are not sufficiently severe as to require head-injury protection from the inflatable lap belt. And because an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the inflatable lap belt useless if a larger impact follows the initial impact. This situation does not exist with energy-absorbing pads or upper-torso restraints, which tend to provide continuous protection regardless of severity or number of impacts in a crash event. Therefore, the inflatable lap-belt installation should be such that the inflatable lap belt will provide protection when it is required, by not expending its protection during a less-severe impact. Also, it is possible to have several large impact events during the course of a crash, but there will be no requirement for the inflatable lap belt to provide protection for multiple impacts.

Given that each occupant's restraint system provides protection for that occupant only, the installation must address unoccupied seats. It will be necessary to show that the required protection is provided for each occupant regardless of the number of occupied seats, and that unoccupied seats may have lap belts that are active.

The inflatable lap belt should be effective for a wide range of occupants. The FAA has historically considered the range from the 5th percentile female to the 95th percentile male as the range of occupants that must be taken into account. In this case, the FAA is proposing consideration of a broader range of occupants due to the nature of the lap-belt installation and its close proximity to the occupant. In a similar vein, these persons could have assumed the brace position for those accidents where an impact is anticipated. Test data indicate that occupants in the brace position do not require supplemental protection, so it would not be necessary to show that the inflatable lap belt will enhance the brace position. However, the inflatable lap belt must not introduce a hazard when it is deployed into a seated, braced occupant.

Another area of concern is the use of seats so equipped by children, whether they are lap-held, sitting in approved child-safety seats, or occupying the seat directly. Although specifically prohibited by FAA operating regulations, the use of the supplementary loop belt (“belly belt”) may be required by other civil aviation authorities, and should also be considered with the end goal of meeting those regulations. Similarly, if the seat is occupied by a pregnant woman, the installation needs to address such usage, either by demonstrating that it will function properly, or by adding appropriate limitation on usage.

The inflatable lap belt will be electrically powered. Likewise, the system could possibly fail due to a separation in the fuselage. Because this system is intended as crash/post-crash protection means, failure due to fuselage separation is not acceptable. As with emergency lighting, the restraint system should function properly if such a separation occurs at any point in the fuselage.

Because the inflatable lap belt is likely to have a large volume displacement, the inflated bag could potentially impede egress of passengers. However, the lap-belt bag deflates to absorb energy, so it is likely that an inflatable lap belt would be deflated by the time passengers begin to leave their seats. Nonetheless, it is appropriate to specify a time interval after which the inflatable lap belt may not impede rapid egress. The maximum time allowed for an exit to open fully after actuation is 10 seconds, according to § 25.809(b)(2). Therefore, the FAA has established 10 seconds as the time interval that the inflatable lap belt must not impede rapid egress from the seat after it is deployed. In actuality, it is unlikely that a flight attendant would prepare an exit this quickly in an accident severe enough to warrant deployment of the inflatable lap belt. The inflatable lap belt will likely deflate much more quickly than 10 seconds.

This potential impediment to rapid egress is even more critical at the seats installed in the emergency-exit rows. Installation of inflatable restraints at the Type III exit rows presents different egress concerns as compared with front-row seats. However, the need to address egress is already part of the special conditions, so there is no change to the special conditions at this time. As noted below, the method of compliance with the special conditions may involve specific considerations when an inflatable restraint is installed at Type III exits. Section 25.813 clearly requires access to the exit from the main aisle in the form of an unobstructed passageway, and no interference in opening the exit. The restraint system must not create an impediment to the access to, and the opening of, the exit. These lap belts should be evaluated in the exit row under existing regulations (§§ 25.809 and 25.813) and guidance material. The inflatable lap belts must also be evaluated in post-crash conditions, and should be evaluated using representative restraint systems in the bag-deployed condition.

This evaluation would include reviewing the access to, and opening of, the exit, specifically for obstructions in the egress path; and any interferences in opening the exit. Each unique interior configuration must be considered, e.g., passageway width, single or dual passageways with outboard seat removed, etc. If the restraint creates any obstruction or interference, it is likely that it could impede rapid egress from the airplane. In some cases, the passenger is the one who will open the exit, such as a Type III over-wing hatch. Project-specific means-of-compliance guidance is likely necessary if these restraint systems are installed at the Type III exit rows.

Note that the special conditions are applicable to the inflatable lap-belt system as installed. The special conditions are not an installation approval. Therefore, while the special conditions relate to each such system installed, the overall installation approval is separate, and must consider the combined effects of all such systems installed.

Embraer will install inflatable lap belts, a novel design feature, on certain seats of Model EMB-545 airplanes, to reduce the potential for head injury if an accident occurs. The inflatable lap belt works similar to an automotive inflatable air bag, except that the air bag in the Embraer design is integrated into the lap belt of the restraint system.

The performance criteria for head-injury protection in objective terms is stated in § 25.562. However, none of these criteria are adequate to address the specific issues raised concerning seats with inflatable lap belts. The FAA has therefore determined that, in addition to the requirements of part 25, special conditions are needed to address requirements particular to the installation of seats with inflatable lap belts.

Accordingly, in addition to the passenger-injury criteria specified in § 25.785, these special conditions are proposed for Embraer Model EMB-545 airplanes equipped with inflatable lap belts. Other conditions may be developed, as needed, based on further FAA review and discussions with the manufacturer and civil-aviation authorities.

For a passenger-safety system, the inflatable lap belt is unique in that it is both an active and entirely autonomous device. While the automotive industry has good experience with inflatable air bags, the conditions of use and reliance on the inflatable lap belt as the sole means of injury protection are quite different. In automobile installations, the air bag is a supplemental system and works in conjunction with an upper-torso restraint. In addition, the crash event is more definable and typically of shorter duration, which can simplify the activation logic. The airplane-operating environment is also quite different from automobiles and includes the potential for greater wear and tear, and unanticipated abuse conditions (due to galley loading, passenger baggage, etc.). Airplanes also operate where exposure to HIRF could affect the lap-belt activation system.

Part I of Appendix F to part 25 specifies the flammability requirements for interior materials and components. There is no reference to inflatable restraint systems in Appendix F, because such devices did not exist at the time the flammability requirements were written. The existing requirements are based on material types as well as use, and have been specified in light of state-of-the-art materials available to perform a given function. Without a specific reference, the default requirement would apply to the type of material used in making the inflatable restraint, which is a fabric in this case. However, in writing special conditions, the FAA must also consider the use of the material, and whether the default requirement is appropriate. In this case, the specialized function of the inflatable restraint means that highly specialized materials are needed. The standard normally applied to fabrics is a 12-second vertical ignition test. However, materials that meet this standard do not perform adequately as inflatable restraints. Because the safety benefit of the inflatable restraint is significant, the flammability standard appropriate for these devices should not screen out suitable materials and thereby effectively eliminate the use of inflatable restraints. The FAA must establish a balance between the safety benefit of the inflatable restraint and its flammability performance. Presently, the 2.5-inch-per-minute horizontal test is considered to provide that balance. As the state-of-the-art in materials progresses (which is expected), the FAA may change this standard in subsequent special conditions to account for improved materials.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions are applicable to Embraer Model EMB-545 airplanes. Should Embraer apply at a later date for a change to the type certificates to include another model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would apply to the other model as well.

This action affects only certain novel or unusual design features on Embraer Model EMB-545 airplanes. It is not a rule of general applicability, and it affects only Embraer Model EMB-545 airplanes listed on amended Type Certificate No. TC00062IB.

1. The inflatable lap belt must be shown to deploy and provide protection under crash conditions where it is necessary to prevent serious head injury. The means of protection must take into consideration a range of stature from a two-year-old child to a 95th percentile male. The inflatable lap belt must provide a consistent approach to energy absorption throughout that range of occupants. In addition, the following situations must be considered.

The seat occupant is:

• holding an infant

• a child in a child-restraint device

• a child not using a child-restraint device

• a pregnant woman

2. The inflatable lap belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the lap belt.

3. The design must prevent the inflatable lap belt from being either incorrectly buckled or incorrectly installed such that the inflatable lap belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required head-injury protection.

4. The inflatable lap-belt system must be shown not to be susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), likely to be experienced in service.

5. Deployment of the inflatable lap belt must not introduce injury mechanisms to the seated occupant, nor result in injuries that could impede rapid egress. This assessment should include an occupant who is in the brace position when it deploys, and an occupant whose inflatable lap belt is loosely fastened.

6. An inadvertent deployment that could cause injury to a standing or sitting person must be shown to be improbable.

7. It must be shown that inadvertent deployment of the airbag system in the lap belt, during the most critical part of the flight, either will not cause a hazard to the airplane or its occupants, or meets the requirement of § 25.1309(b).

8. The inflatable lap belt must be shown to not impede rapid egress of occupants 10 seconds after its deployment.

9. The inflatable lap-belt system must be protected from lightning and HIRF. The threats specified in existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection. For the purposes of complying with HIRF requirements, the inflatable lap-belt system is considered a “critical system” if its deployment could have a hazardous effect on the airplane; otherwise it is considered an “essential” system.

10. The inflatable lap belt must function properly after loss of normal airplane electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the lap belt does not have to be considered.

11. The inflatable lap belt must be shown to not release hazardous quantities of gas or particulate matter into the cabin.

12. The inflatable lap-belt installation must be protected from the effects of fire such that no hazard to occupants will result.

13. A means must be available for a crewmember to verify the integrity of the inflatable-lap-belt-activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals.

14. The inflatable material may not have an average burn rate of greater than 2.5 inches per minute when tested using the horizontal-flammability test as defined in 14 CFR part 25, Appendix F, Part I(b)(5).

15. The airbag system in the lap belt, once deployed, must not adversely affect the emergency-lighting system (i.e., block floor-proximity lights to the extent that the lights no longer meet their intended function).

The FAA has determined that notice of, and opportunity for, prior public comment on these special conditions are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplane.

In addition, the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On February 3, 2014, the Boeing Company applied for an amendment to Type Certificate no. A20WE to allow installation of inflatable lap belts for head-injury protection on certain seats in Boeing Model 747-8 airplanes.

The Model 747-8 airplane, a derivative of the Model 747-400 airplane, is a bi-level, wide-body airplane powered by four wing-mounted General Electric GEnx-2B engines. The airplane will have a maximum seating capacity of 605 passengers and two crew members, and a maximum takeoff weight of 987,000 pounds.

The Boeing Company requested special conditions to allow inflatable lap belts on Boeing Model 747-8 series airplanes, similar to Special Conditions no. 25-386-SC for Boeing Model 737 series airplanes; 25-187A-SC for Boeing Model 777 series airplanes; 25-148-SC for Boeing Model 767 series airplanes; and 25-431-SC for Boeing Model 787 series airplanes. These special conditions will allow installation of inflatable lap belts for head-injury protection on certain seats in Boeing Model 747-8 airplanes. Section 121.311(j) of 14 CFR requires that no person may operate a transport-category airplane type-certificated after January 1, 1958, and manufactured on or after October 27, 2009, in passenger-carrying operations after October 27, 2009, unless all passenger and flight-attendant seats on the airplane, operated under part 121 rules, meet the requirements of § 25.562 in effect on or after June 16, 1988.

The Boeing Model 747-8 airplane, operated under part 121, must meet all of the requirement of § 25.562 for passenger and flight-attendant seats. Therefore, it is in the interest of installers to show full compliance to § 25.562, so that an operator under part 121 may be able to use the airplane without having to conduct additional certification work. The FAA also notes that some foreign civil airworthiness authorities have invoked these same operator requirements in the form of airworthiness directives.

Occupants must be protected from head injury, as required by § 25.785, either by eliminating any injurious object within the striking radius of the head, or by installing padding. Traditionally, this has required either a setback of 35 inches from any bulkhead or other rigid interior feature or, where not practical, the installation of specified types of padding. The relative effectiveness of these established means of injury protection was not quantified. With the adoption of Amendment 25-64 to part 25, specifically § 25.562, a new standard was created that quantifies required head-injury protection.

Each seat-type design approved for crew or passenger occupancy during takeoff and landing, as required by § 25.562, must successfully complete dynamic tests or be demonstrated by rational analysis based on dynamic tests of a similar type seat. In particular, the regulations require that persons not suffer serious head injury under the conditions specified in the tests, and that protection must be provided, or the seat be designed, so that head impact does not exceed a HIC value of 1,000 units. While the test conditions described for HIC are detailed and specific, it is the intent of the requirement that an adequate level of head-injury protection be provided for passengers in a severe crash.

Because §§ 25.562 and 25.785 and associated guidance do not adequately address seats with inflatable lap belts, the FAA recognizes that appropriate pass/fail criteria need to be developed that fully address the safety concerns specific to occupants of these seats.

Under the provisions of 14 CFR 21.101, Boeing must show that the Model 747-8 airplane meets the applicable provisions of the regulations listed in Type Certificate no. A20WE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in Type Certificate no. A20WE are as follows:

14 CFR part 25, Amendments 25-1 through 25-120, with exceptions permitted by § 21.101. In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for Boeing Model 747-8 airplanes because of a novel or unusual design feature, special conditions are prescribed under § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 747-8 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

Boeing Model 747-8 airplanes will incorporate the following novel or unusual design feature: Seats with inflatable lap belts. The inflatable lap belt is designed to limit occupant forward excursion in the event of an accident. This will reduce the potential for head injury, thereby reducing the Head Injury Criterion (HIC) measurement as required by Title 14, Code of Federal Regulations (14 CFR), 25.562(c)(5). The inflatable lap belt functions similarly to an automotive inflatable airbag, but in this case, the airbag is integrated into the lapbelt, and inflates away from the seated occupant. While inflatable airbags are now standard in the automotive industry, the use of an inflatable lap belt is novel for commercial aviation.

The inflatable lap belt has two potential advantages over other means of head-impact protection. First, it can provide significantly greater protection than would be expected with energy-absorbing pads, and second, it can provide essentially equivalent protection for occupants of all stature. These are significant advantages from a safety standpoint, because such devices will likely provide a level of safety that exceeds the minimum standards of part 25. Conversely, inflatable lap belts in general are active systems and must be relied upon to activate properly when needed, as opposed to an energy-absorbing pad or upper torso restraint that is passive and always available. Therefore, the potential advantages must be balanced against this and other potential disadvantages to develop standards for this design feature.

The FAA has considered the installation of inflatable lap belts to have two primary safety concerns: First, that they perform properly under foreseeable operating conditions; and second, that they do not perform in a manner or at such times as would constitute a hazard to the airplane or occupants. This latter point has the potential to be the more rigorous of the requirements, owing to the active nature of the system.

The inflatable lap belt will rely on electronic sensors for signaling, and will employ an automatic inflation mechanism for activation, so that it is available when needed. These same devices could be susceptible to inadvertent activation, causing deployment in a potentially unsafe manner. The consequences of such deployment must be considered in establishing the reliability of the system. Boeing must substantiate that the effects of an inadvertent deployment in flight are either not a hazard to the airplane, or that such deployment is an extremely improbable occurrence (less than 10−9 per flight hour). The effect of an inadvertent deployment on a passenger or crewmember that might be positioned close to the inflatable lap belt should also be considered. The person could be either standing or sitting. A minimum reliability level will have to be established for this case, depending upon the consequences, even if the effect on the airplane is negligible.

The potential for an inadvertent deployment could be increased as a result of conditions in service. The installation must take into account wear and tear so that the likelihood of an inadvertent deployment is not increased to an unacceptable level. In this context, an appropriate inspection interval and self-test capability are considered necessary. Other outside influences are lightning and high-intensity radiated fields (HIRF). Existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are applicable. For compliance with those conditions, if inadvertent deployment could cause a hazard to the airplane, the inflatable lap belt is considered a critical system; if inadvertent deployment could cause injuries to persons, the inflatable lap belt should be considered an essential system. Finally, the inflatable lap-belt installation should be protected from the effects of fire, so that an additional hazard is not created by, for example, a rupture of a pyrotechnic squib.

To function as an effective safety system, the inflatable lap belt must function properly and must not introduce any additional hazards to occupants as a result of its functioning. The inflatable lap belt differs variously from traditional occupant-protection systems and requires special conditions to ensure adequate performance.

Because the inflatable lap belt is essentially a single-use device, it could potentially deploy under crash conditions that are not sufficiently severe as to require head-injury protection from the inflatable lap belt. And because an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the inflatable lap belt useless if a larger impact follows the initial impact. This situation does not exist with energy-absorbing pads or upper-torso restraints, which tend to provide continuous protection regardless of severity or number of impacts in a crash event. Therefore, the inflatable lap-belt installation should be such that the inflatable lap belt will provide protection when it is required, by not expending its protection during a less-severe impact. Also, it is possible to have several large impact events during the course of a crash, but there will be no requirement for the inflatable lap belt to provide protection for multiple impacts.

Given that each occupant's restraint system provides protection for that occupant only, the installation must address unoccupied seats. It will be necessary to show that the required protection is provided for each occupant regardless of the number of occupied seats, and that unoccupied seats may have lap belts that are active.

The inflatable lap belt should be effective for a wide range of occupants. The FAA has historically considered the range from the 5th percentile female to the 95th percentile male as the range of occupants that must be taken into account. In this case, the FAA is proposing consideration of a broader range of occupants due to the nature of the lap-belt installation and its close proximity to the occupant. In a similar vein, these persons could have assumed the brace position for those accidents where an impact is anticipated. Test data indicate that occupants in the brace position do not require supplemental protection, so it would not be necessary to show that the inflatable lap belt will enhance the brace position. However, the inflatable lap belt must not introduce a hazard when it is deployed into a seated, braced occupant.

Another area of concern is the use of seats so equipped by children, whether they are lap-held, sitting in approved child-safety seats, or occupying the seat directly. Although specifically prohibited by FAA operating regulations, the use of the supplementary loop belt (“belly belt”) may be required by other civil aviation authorities, and should also be considered with the end goal of meeting those regulations. Similarly, if the seat is occupied by a pregnant woman, the installation needs to address such usage, either by demonstrating that it will function properly, or by adding appropriate limitation on usage.

The inflatable lap belt will be electrically powered. Likewise, the system could possibly fail due to a separation in the fuselage. Because this system is intended as crash/post-crash protection means, failure due to fuselage separation is not acceptable. As with emergency lighting, the restraint system should function properly if such a separation occurs at any point in the fuselage.

Because the inflatable lap belt is likely to have a large volume displacement, the inflated bag could potentially impede egress of passengers. However, the lap-belt bag deflates to absorb energy, so it is likely that an inflatable lap belt would be deflated by the time passengers begin to leave their seats. Nonetheless, it is appropriate to specify a time interval after which the inflatable lap belt may not impede rapid egress. The maximum time allowed for an exit to open fully after actuation is 10 seconds, according to § 25.809(b)(2). Therefore, the FAA has established 10 seconds as the time interval that the inflatable lap belt must not impede rapid egress from the seat after it is deployed. In actuality, it is unlikely that a flight attendant would prepare an exit this quickly in an accident severe enough to warrant deployment of the inflatable lap belt. The inflatable lap belt will likely deflate much more quickly than 10 seconds.

This potential impediment to rapid egress is even more critical at the seats installed in the emergency-exit rows. Installation of inflatable restraints at the Type III exit rows presents different egress concerns as compared with front-row seats. However, the need to address egress is already part of the special conditions, so there is no change to the special conditions at this time. As noted below, the method of compliance with the special conditions may involve specific considerations when an inflatable restraint is installed at Type III exits. Section 25.813 clearly requires access to the exit from the main aisle in the form of an unobstructed passageway, and no interference in opening the exit. The restraint system must not create an impediment to the access to, and the opening of, the exit. These lap belts should be evaluated in the exit row under existing regulations (§§ 25.809 and 25.813) and guidance material. The inflatable lap belts must also be evaluated in post-crash conditions, and should be evaluated using representative restraint systems in the bag-deployed condition.

This evaluation would include reviewing the access to, and opening of, the exit, specifically for obstructions in the egress path; and any interferences in opening the exit. Each unique interior configuration must be considered, e.g., passageway width, single or dual passageways with outboard seat removed, etc. If the restraint creates any obstruction or interference, it is likely that it could impede rapid egress from the airplane. In some cases, the passenger is the one who will open the exit, such as a Type III over-wing hatch. Project-specific means-of-compliance guidance is likely necessary if these restraint systems are installed at the Type III exit rows.

Note that the special conditions are applicable to the inflatable lap-belt system as installed. The special conditions are not an installation approval. Therefore, while the special conditions relate to each such system installed, the overall installation approval is separate, and must consider the combined effects of all such systems installed.

Boeing will install inflatable lap belts, a novel design feature, on certain seats of Model 747-8 airplanes, to reduce the potential for head injury if an accident occurs. The inflatable lap belt works similar to an automotive inflatable air bag, except that the air bag in the Boeing design is integrated into the lap belt of the restraint system.

The performance criteria for head-injury protection in objective terms is stated in § 25.562. However, none of these criteria are adequate to address the specific issues raised concerning seats with inflatable lap belts. The FAA has therefore determined that, in addition to the requirements of part 25, special conditions are needed to address requirements particular to the installation of seats with inflatable lap belts.

Accordingly, in addition to the passenger-injury criteria specified in § 25.785, these special conditions are proposed for the Boeing Model 747-8 airplanes equipped with inflatable lap belts. Other conditions may be developed, as needed, based on further FAA review and discussions with the manufacturer and civil-aviation authorities.

For a passenger-safety system, the inflatable lap belt is unique in that it is both an active and entirely autonomous device. While the automotive industry has good experience with inflatable air bags, the conditions of use and reliance on the inflatable lap belt as the sole means of injury protection are quite different. In automobile installations, the air bag is a supplemental system and works in conjunction with an upper-torso restraint. In addition, the crash event is more definable and typically of shorter duration, which can simplify the activation logic. The airplane-operating environment is also quite different from automobiles and includes the potential for greater wear and tear, and unanticipated abuse conditions (due to galley loading, passenger baggage, etc.). Airplanes also operate where exposure to HIRF could affect the lap-belt activation system.

The current special conditions for the Boeing Model 777 airplane were amended to address flammability of the airbag material. During the development of the inflatable lap belt, the manufacturer was unable to develop a fabric that would meet the inflation requirements for the bag and the flammability requirements of part 25, Appendix F, Part I(a)(1)(ii). The fabrics that were developed that meet the flammability requirement did not produce acceptable deployment characteristics. However, the manufacturer was able to develop a fabric that not only meets the flammability requirements of part 25, Appendix F, Part I(a)(1)(ii), but also has acceptable deployment characteristics.

Part I of Appendix F to part 25 specifies the flammability requirements for interior materials and components. There is no reference to inflatable restraint systems in Appendix F, because such devices did not exist at the time the flammability requirements were written. The existing requirements are based on material types as well as use, and have been specified in light of state-of-the-art materials available to perform a given function. Without a specific reference, the default requirement would apply to the type of material used in making the inflatable restraint, which is a fabric in this case. However, in writing special conditions, the FAA must also consider the use of the material, and whether the default requirement is appropriate. In this case, the specialized function of the inflatable restraint means that highly specialized materials are needed. The standard normally applied to fabrics is a 12-second vertical ignition test. However, materials that meet this standard do not perform adequately as inflatable restraints. Because the safety benefit of the inflatable restraint is significant, the flammability standard appropriate for these devices should not screen out suitable materials and thereby effectively eliminate the use of inflatable restraints. The FAA must establish a balance between the safety benefit of the inflatable restraint and its flammability performance. Presently, the 2.5-inch-per-minute horizontal test is considered to provide that balance. As the state-of-the-art in materials progresses (which is expected), the FAA may change this standard in subsequent special conditions to account for improved materials.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions are applicable to the Boeing Model 747-8 airplanes. Should Boeing apply at a later date for a change to the type certificates to include another model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would apply to the other model as well.

This action affects only certain novel or unusual design features on the Boeing Model 747-8 airplanes. It is not a rule of general applicability, and it affects only Boeing Model 747-8 airplanes listed on amended Type Certificate no. A20WE.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the administrator, the following special conditions are issued as part of the type certification basis for Boeing Model 747-8 airplanes with inflatable lap belts installed.

1. The inflatable lap belt must be shown to deploy and provide protection under crash conditions where it is necessary to prevent serious head injury. The means of protection must take into consideration a range of stature from a two-year-old child to a 95th percentile male. The inflatable lap belt must provide a consistent approach to energy absorption throughout that range of occupants. In addition, the following situations must be considered.

The seat occupant is:

• Holding an infant

• a child in a child-restraint device

• a child not using a child-restraint device

• a pregnant woman

2. The inflatable lap belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the lap belt.

3. The design must prevent the inflatable lap belt from being either incorrectly buckled or incorrectly installed such that the inflatable lap belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required head-injury protection.

4. The inflatable lap-belt system must be shown not to be susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), likely to be experienced in service.

5. Deployment of the inflatable lap belt must not introduce injury mechanisms to the seated occupant, nor result in injuries that could impede rapid egress. This assessment should include an occupant who is in the brace position when it deploys, and an occupant whose inflatable lap belt is loosely fastened.

6. An inadvertent deployment that could cause injury to a standing or sitting person must be shown to be improbable.

7. It must be shown that inadvertent deployment of the airbag system in the lap belt, during the most critical part of the flight, either will not cause a hazard to the airplane or its occupants, or meets the requirement of § 25.1309(b).

8. The inflatable lap belt must be shown to not impede rapid egress of occupants 10 seconds after its deployment.

9. The inflatable lap-belt system must be protected from lightning and HIRF. The threats specified in existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection. For the purposes of complying with HIRF requirements, the inflatable lap-belt system is considered a “critical system” if its deployment could have a hazardous effect on the airplane; otherwise it is considered an “essential” system.

10. The inflatable lap belt must function properly after loss of normal airplane electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the lap belt does not have to be considered.

11. The inflatable lap belt must be shown to not release hazardous quantities of gas or particulate matter into the cabin.

12. The inflatable lap-belt installation must be protected from the effects of fire such that no hazard to occupants will result.

13. A means must be available for a crewmember to verify the integrity of the inflatable-lap-belt-activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals.

14. The inflatable material may not have an average burn rate of greater than 2.5 inches per minute when tested using the horizontal-flammability test as defined in 14 CFR part 25, Appendix F, Part I(b)(5).

15. The airbag system in the lap belt, once deployed, must not adversely affect the emergency-lighting system (i.e., block floor-proximity lights to the extent that the lights no longer meet their intended function).

The FAA has determined that notice of, and opportunity for, prior public comment on these special conditions are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplane.

In addition, the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On July 7, 2014, Flight Structures, Inc., applied for a supplemental type certificate to allow the installation of oblique business-class passenger seats, positioned at 32.5 degrees to the vertical plane of the airplane longitudinal centerline, and to include inflatable lap belts, in Boeing Model 777-200 airplanes.

The seating configuration Flight Structures, Inc., proposes in certification plan No. B3FS332-D10 includes the installation of TSO-39c-approved, Zodiac Aries model, side-facing, pod-style, business-class seats (with surrounding shells and front-row furniture), installed at an angle of up to 32.5 degrees to the airplane longitudinal centerline. These seats will include restraint (airbag) systems for occupant restraint and injury protection.

The Boeing Model 777-200 airplane, approved under Type Certificate No. T00001SE, is a swept-wing, conventional-tail, twin-engine, turbofan-powered transport airplane, with seating capacity for 440 passengers.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Flight Structures, Inc., must show that the Model 777-200 airplane, as changed, meets the applicable provisions of the regulations listed in Type Certificate No. T00001SE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type- certification basis.” The regulations listed in Type Certificate No. T00001SE are as follows:

14 CFR part 25, Amendments 25-1 through 25-82, with exceptions listed in the type-certification data sheet. In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for Boeing Model 777-200 airplanes because of a novel or unusual design feature, special conditions are prescribed under § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777-200 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The business-class seating configuration Flight Structures, Inc., proposes is novel and unusual due to the seat installation at 32.5 degrees to the aircraft centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration also is beyond the limits of current acceptable equivalent-level-of-safety findings.

Ongoing research is progressing to establish acceptable limits. Until those limits become available, the FAA proposes a set of interim limits based on the current literature available, current National Highway Traffic Safety Administration (NHTSA) regulations, and preliminary test data from the research program.

The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785. The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.

Amendment 25-15 to part 25, dated October 24, 1967, introduced the subject of side-facing seats, and a requirement that each occupant in a side-facing seat must be protected from head injury by a safety belt and a cushioned rest that will support the arms, shoulders, head, and spine.

Subsequently, Amendment 25-20, dated April 23, 1969, clarified the definition of side-facing seats to require that each occupant of a seat, positioned at more than an 18-degree angle to the vertical plane of the airplane longitudinal centerline, must be protected from head injury by a safety belt and an energy-absorbing rest that will support the arms, shoulders, head, and spine; or by a safety belt and shoulder harness that will prevent the head from contacting any injurious object. The FAA concluded that an 18-degree angle would provide an adequate level of safety based on tests that were performed at that time, and thus adopted that standard.

Part 25 was amended June 16, 1988, by Amendment 25-64, to revise the emergency-landing conditions that must be considered in the design of the airplane. Amendment 25-64 revised the static-load conditions in 14 CFR 25.561, and added the new § 25.562 that requires dynamic testing for all seats approved for occupancy during takeoff and landing. The intent of Amendment 25-64 is to provide an improved level of safety for occupants on transport-category airplanes. Because most seating is forward-facing on transport-category airplanes, the pass/fail criteria developed in Amendment 25-64 focused primarily on these seats. As a result, the FAA issued Policy Memorandums ANM-03-115-30 and PS-ANM-100-2000-00123 to provide the additional guidance necessary to demonstrate the level of safety required by the regulations for side-facing seats.

To reflect current research findings, the FAA developed a methodology to address all fully side-facing seats (i.e., seats positioned in the airplane with the occupant facing 90 degrees to the vertical plane of the airplane centerline), and has documented those requirements in a set of new special conditions. The FAA issued Policy Statement PS-ANM-25-03-R1 to define revised injury criteria associated with neck and leg injuries.

The proposed Model 777-200 airplane business-class seat installation is novel such that the current Model 777-200 airplane certification basis does not adequately protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. Therefore, the Flight Structures, Inc., proposed configuration will require new special conditions.

These special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions are applicable to the Boeing Model 777-200 airplanes configured with the business-class seating defined in Flight Structures, Inc., certification plan No. B3FS332-D10. Should Flight Structures, Inc., apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. T00001SE to incorporate the same novel or unusual design feature, these special conditions would apply to the other model as well.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability, and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances, and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Boeing Model 777-200 airplane.

In a notice published in the Federal Register on April 22, 2015 (80 FR 22449), we announced that we filed a color additive petition (CAP 5C0302) to amend the color additive regulations in § 73.350 Mica-based pearlescent pigments (21 CFR 73.350).

CAP 5C0302 was submitted by E. & J. Gallo Winery, c/o Keller and Heckman LLP, Three Embarcadero Center, Suite 1420, San Francisco, CA 94111 (petitioner). In CAP 5C0302, E. & J. Gallo Winery proposed to amend the color additive regulations in § 73.350 to increase the maximum permitted alcohol content of distilled spirits to which mica-based pearlescent pigments may be added from 23 percent to 25 percent alcohol by volume, and to remove the current limitation for distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis. The term “distilled spirits” is defined by the Alcohol and Tobacco Tax and Trade Bureau as ethyl alcohol, hydrated oxide of ethyl, spirits of wine, whisky, rum, brandy, gin, and other distilled spirits, including all dilutions and mixtures thereof, for nonindustrial use. The term does not include mixtures containing wine, bottled at 48 degrees of proof or less, if the mixture contains more than 50 percent wine on a proof gallon basis (27 CFR 5.11).

Mica-based pearlescent pigments prepared from titanium dioxide and mica are currently approved under § 73.350(c)(1)(i) for use as a color additive in amounts up to 1.25 percent, by weight, in cereals, confections and frostings, gelatin deserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. They are also approved under § 73.350(c)(1)(ii) in amounts up to 0.07 percent, by weight, in: Distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis (§ 73.350(c)(1)(ii)(A)); cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, and cocktails (§ 73.350(c)(1)(ii)(B)); and non-alcoholic cocktail mixes and mixers, such as margarita mix, Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water, and beverages that are typically consumed without added alcohol (e.g., fruit juices, fruit juice drinks, and soft drinks) (§ 73.350(c)(1)(ii)(C)). The pigments also are approved under § 73.350(c)(1)(iii) in egg decorating kits used for coloring the shells of eggs in amounts consistent with good manufacturing practice. Mica-based pearlescent pigments prepared from titanium dioxide on mica, iron oxide on mica, and titanium dioxide and iron oxide on mica are approved for use as a color additive in ingested drugs under § 73.1350 (21 CFR 73.1350). Mica-based pearlescent pigments formed by depositing titanium or iron salts from a basic solution onto mica, followed by calcination to produce titanium dioxide or iron oxides on mica, are approved for use in contact lenses under § 73.3128 (21 CFR 73.3128). The color additive that is mica-based pearlescent pigments prepared from titanium dioxide and mica will be referred hereinafter in this final rule as mica-based pearlescent pigments.

Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establishes that the color additive is safe for that use. FDA's color additive regulations in 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. To establish with reasonable certainty that a color additive intended for use in food is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare an individual's estimated daily intake (EDI) of the additive from all sources to an acceptable daily intake (ADI) established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all sources of the additive. We typically use the EDI for the 90th percentile consumer of a color additive as a measure of high chronic dietary exposure.

During our safety review of the use of mica-based pearlescent pigments proposed in CAP 5C0302, we considered the exposure to the color additive from its petitioned use and from the currently permitted uses in food and ingested drugs under §§ 73.350 and 73.1350, respectively. In estimating the cumulative estimated dietary intake (CEDI) of these pigments, we determined that the exposure to mica-based pearlescent pigments from the use in egg decorating kits used for coloring the shells of boiled eggs and in contact lenses (§§ 73.350(c)(1)(iii) and 73.3128, respectively) is negligible and, therefore, does not contribute to the exposure.

The petitioner estimated the eaters-only exposure to mica-based pearlescent pigments from the proposed use in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume at 0.14 grams per person per day (g/p/d) at the mean and 0.31 g/p/d at the 90th percentile for the U.S. population (Ref. 1). (An eaters-only exposure is the total of the amount of food consumed per day averaged over the number of days in the survey period by individuals consuming the food at least once during the survey period.) We conclude that the petitioner's exposure estimates are sufficiently conservative to account for the petitioned use of mica-based pearlescent pigments. Regarding cumulative exposure from the current and petitioned uses of mica-based pearlescent pigments, we note that in our recent final rule that provided for the safe use of mica-based pearlescent pigments as color additives in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs, we estimated the CEDI for the use of mica-based pearlescent pigments in food (§ 73.350) and ingested drugs (§ 73.1350) to be 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile for the U.S. population (80 FR 32303 at 32305, June 8, 2015). Since the petitioned use of mica-based pearlescent pigments will generally substitute for currently-permitted uses of mica-based pearlescent pigments in other alcoholic beverages with no change in the maximum use level of 0.07 percent by weight, we have determined that the petitioned use of mica-based pearlescent pigments will not result in an increase in consumer exposure to these pigments. Therefore, we conclude that our previous CEDI for mica-based pearlescent pigments of 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile for the U.S. population will remain unchanged (Ref. 1).

To support the safety of the proposed use of mica-based pearlescent pigments in food, the petitioner referenced the safety determination made by FDA for previously filed petitions (70 FR 42271, July 22, 2005); (71 FR 31927, June 2, 2006); and (78 FR 35115, June 12, 2013); including our previously established ADI for mica-based pearlescent pigments of 1.8 g/p/d based on a 2-year rat carcinogenicity bioassay (71 FR 31927 at 31928). Because there is no increase in the intake of mica-based pearlescent pigments beyond a level that has already been established as safe, FDA has no concerns regarding the petitioned use of mica-based pearlescent pigments in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume (Ref. 2).

Based on the data and information in the petition and other relevant material, FDA concludes that the petitioned use of mica-based pearlescent pigments prepared from titanium dioxide and mica as a color additive at a level of up to 0.07 percent by weight in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume, is safe. We further conclude that the additive will achieve its intended technical effect and is suitable for the petitioned use. Therefore, we are amending the color additive regulations in part 73 as set forth in this document. In addition, based upon the factors listed in 21 CFR 71.20(b), we conclude that certification of mica-based pearlescent pigments prepared from titanium dioxide and mica is not necessary for the protection of the public health.

In accordance with § 71.15 (21 CFR 71.15), the petitions and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 71.15, we will delete from the documents any materials that are not available for public disclosure.

We previously considered the environmental effects of this rule, as stated in the April 22, 2015 notice of filing for CAP 5C0302 (80 FR 22449). We stated that we had determined, under 21 CFR 25.32(k), that this action is of a type that does not individually or cumulatively have a significant effect on the human environment such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that would affect our previous determination.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Our review of this petition was limited to section 721 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive final rules that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday and are available electronically at http://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 73 is amended as follows:

I. Background

In the Federal Register of June 3, 2015 (80 FR 31520), FDA published a notice of availability for a draft guidance entitled “Veterinary Feed Directive Regulation Questions and Answers” giving interested persons until August 3, 2015, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated June 2015. This guidance also serves as a Small Entity Compliance Guide (SECG) to aid industry in complying with the requirements of the VFD final rule that published in the Federal Register on June 3, 2015 (80 FR 31708). FDA has prepared this SECG in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). This document is intended to provide guidance to small businesses on the requirements of the final rule.

In 1996, Congress enacted the Animal Drug Availability Act (ADAA) to facilitate the approval and marketing of new animal drugs and medicated feeds. In passing the ADAA, Congress created a new regulatory category for certain animal drugs used in animal feed called VFD drugs. VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. FDA published final regulations implementing the VFD-related provisions of the ADAA in 2000. On June 3, 2015, FDA published a VFD final rule that revised those VFD regulations and introduced clarifying changes to specified definitions, and published the draft revised guidance for comment.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on VFD regulation questions and answers. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

This guidance refers to previously approved collections of information found in 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 21 CFR 558.6 have been approved under OMB control number 0910-0363.

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

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) of the FD&C Act. 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 will classify the device by written order within 120 days. This classification will be the initial classification of the device.

On February 14, 2014, Catheter Robotics, Inc. submitted a request for classification of the AMIGO Remote Catheter System under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).

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 December 18, 2014, 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 870.5700.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a steerable cardiac ablation catheter remote control system will need to comply with the special controls named in this final order. The device is assigned the generic name steerable cardiac ablation catheter remote control system, and it is identified as a prescription device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.

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

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

• Non-clinical mechanical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be performed:

○ Mechanical performance of the system (without catheter connected);

○ mechanical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following:

Side-by side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and

evaluation of the accuracy and function of all device control safety features; and

○ simulated-use testing in a bench anatomic model or animal model.

• Non-clinical electrical testing must include validation of EMC, electrical safety, thermal safety, and electrical system performance. The following performance testing must be performed:

○ Electrical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following:

Side-by side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and

evaluation of the accuracy and function of all device control safety features; and

○ electrical safety between the device and ablation catheter system and with other electrical equipment expected in the catheter lab or operating room.

• In vivo testing must demonstrate that the device performs as intended under anticipated conditions of use, including an assessment of the system impact on the functionality and performance of compatible catheters, and documentation of the adverse event profile associated with clinical use. Evidence must be submitted to address the following:

○ Manipulation and positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and confirm proper anatomic placement and tissue contact, in accordance with the system indications for use and the compatible catheter indications for use;

○ Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use;

○ Efficacy: Assess ablation success in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; and

○ User assessment of device remote controls and safety features.

• Post-market surveillance (PMS) must be conducted and completed in accordance with FDA-agreed upon PMS protocol.

• A training program must be included with sufficient educational elements that, upon completion of the training program, the clinician and supporting staff can

○ Identify the safe environments for device use,

○ use all safety features of device, and

○ operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters.

• Performance data must demonstrate the sterility of the sterile disposable components of the system.

• Performance data must support shelf life by demonstrating continued sterility of the device (of the sterile disposable components), package integrity, and device functionality over the requested shelf life.

• Labeling must include the following:

○ Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the safe use of the device;

○ specific instructions and the clinical training needed for the safe use of the device, which includes:

instructions on assembling the device in all available configurations, including installation and removal of compatible catheters;

instructions and explanation of all controls, inputs, and outputs;

instructions on all available modes or states of the device;

instructions on all safety features of the device; and

validated methods and instructions for reprocessing/disinfecting any reusable components;

○ a detailed summary of the mechanical compatibility testing including:

A table with a complete list of compatible catheters tested (manufacturer trade name and model number), and

a table with detailed test results, including type of test, acceptance criteria, and test results (i.e., pass for meeting acceptance criteria);

○ a detailed summary of the in vivo testing including:

a table with a complete list of compatible catheters used during testing (manufacturer trade name and model number);

adverse events encountered pertinent to use of the device under use conditions;

a detailed summary of the device- and procedure-related complications; and

a summary of study outcomes and endpoints. Information pertinent to the fluoroscopy times/exposure for the procedure, patient and operator fluoroscopic exposure;

○ other labeling items:

a detailed summary of pertinent non-clinical testing information: EMC, mechanical, electrical, and sterilization of device and components;

a detailed summary of the device technical parameters; and

an expiration date/shelf life and storage conditions for the sterile accessories; and

○ when available, and according to the timeframe included in the PMS protocol agreed upon with FDA, provide a detailed summary of the PMS data including:

Updates to the labeling to accurately reflect outcomes or necessary modifications based upon data collected during the PMS experience, and

inclusion of results and adverse events associated with utilization of the device during the PMS.

The steerable cardiac ablation catheter remote control system is a prescription device restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; 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 steerable cardiac ablation catheter remote control system they intend to market.

The Agency has determined under 21 CFR 25.33(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 establishes special controls that refer 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 21 CFR 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 801, regarding labeling, have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding postmarket surveillance, have been approved under OMB control number 0910-0449.

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

This direct final rule makes changes to the Office of the Secretary Privacy Program rules. These changes will allow the Department to add an exemption rule to the Office of the Secretary of Defense Privacy Program rules that will exempt applicable Department records and/or material from certain portions of the Privacy Act.

This rule is being published as a direct final rule as the Department of Defense does not expect to receive any adverse comments, and so a proposed rule is unnecessary.

DoD has determined this rulemaking meets the criteria for a direct final rule because it involves non-substantive changes dealing with DoD's management of its Privacy Programs. DoD expects no opposition to the changes and no significant adverse comments. However, if DoD receives a significant adverse comment, the Department will withdraw this direct final rule by publishing a notice in the Federal Register. A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, DoD will consider whether it warrants a substantive response in a notice and comment process.

It has been determined that Privacy Act rules for the Department of Defense are not significant rules. This rule does not (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive orders.

It has been determined that this Privacy Act rule for the Department of Defense does not have significant economic impact on a substantial number of small entities because it is concerned only with the administration of Privacy Act systems of records within the Department of Defense. A Regulatory Flexibility Analysis is not required.

It has been determined that this Privacy Act rule for the Department of Defense imposes no information requirements beyond the Department of Defense and that the information collected within the Department of Defense is necessary and consistent with 5 U.S.C. 552a, known as the Privacy Act of 1974.

It has been determined that this Privacy Act rule for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that this rulemaking will not significantly or uniquely affect small governments.

It has been determined that this Privacy Act rule for the Department of Defense does not have federalism implications. This rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, no Federalism assessment is required.

Privacy.

Accordingly, 32 CFR part 311 is amended to read as follows:

This direct final rule makes non-substantive changes to the Office of the Secretary Privacy Program rules. These changes will allow the Department to add an exemption rule to the Office of the Secretary of Defense Privacy Program rules that will exempt applicable Department records and/or material from certain portions of the Privacy Act.

This rule is being published as a direct final rule as the Department of Defense does not expect to receive any adverse comments, and so a proposed rule is unnecessary.

DoD has determined this rulemaking meets the criteria for a direct final rule because it involves non-substantive changes dealing with DoD's management of its Privacy Programs. DoD expects no opposition to the changes and no significant adverse comments. However, if DoD receives a significant adverse comment, the Department will withdraw this direct final rule by publishing a notice in the Federal Register. A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, DoD will consider whether it warrants a substantive response in a notice and comment process.

It has been determined that Privacy Act rules for the Department of Defense are not significant rules. This rule does not (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive orders.

It has been determined that this Privacy Act rule for the Department of Defense does not have significant economic impact on a substantial number of small entities because it is concerned only with the administration of Privacy Act systems of records within the Department of Defense. A Regulatory Flexibility Analysis is not required.

It has been determined that this Privacy Act rule for the Department of Defense imposes no information requirements beyond the Department of Defense and that the information collected within the Department of Defense is necessary and consistent with 5 U.S.C. 552a, known as the Privacy Act of 1974.

It has been determined that this Privacy Act rule for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that this rulemaking will not significantly or uniquely affect small governments.

It has been determined that this Privacy Act rule for the Department of Defense does not have federalism implications. This rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, no Federalism assessment is required.

Accordingly, 32 CFR part 311 is amended to read as follows:

California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other times the draw shall open on signal if at least four hours notice is given, as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 11 a.m. to 1 p.m. on October 3, 2015, to allow the community to participate in the 5K Walk to Defeat ALS. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. 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 that vessels 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.

California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other times the draw shall open on signal if at least four hours notice is given, as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 7:30 a.m. to 10 a.m. on October 4, 2015, to allow the community to participate in the Urban Cow Half Marathon. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. 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 that vessels 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.

This document identifies updates to the product lists, which appear as 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule. Publication of the updated product lists in the Federal Register is addressed in the Postal Accountability and Enhancement Act (PAEA) of 2006.

Authorization. The Commission process for periodic publication of updates was established in Docket Nos. MC2010-21 and CP2010-36, Order No. 445, April 22, 2010, at 8.

Changes. The product lists are being updated by publishing a replacement in its entirety of 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule. The following products are being added, removed, or moved within the product lists:

1. Global Expedited Package Services (GEPS)—Non-Published Rates 7 (MC2015-55 and CP2015-83) (Order No. 2558), added July 1, 2015.

2. Priority Mail Contract 126 (MC2015-56 and CP2015-84) (Order No. 2559), added July 2, 2015.

3. Priority Mail & First-Class Package Service Contract 5 (MC2015-57 and CP2015-85) (Order No. 2560), added July 2, 2015.

4. Parcel Return Service Contract 9 (MC2015-58 and CP2015-88) (Order No. 2569), added July 8, 2015.

5. Priority Mail Contract 127 (MC2015-60 and CP2015-90) (Order No. 2570), added July 8, 2015.

6. Parcel Return Service Contract 10 (MC2015-59 and CP2015-89) (Order No. 2572), added July 8, 2015.

7. Priority Mail Contract 129 (MC2015-62 and CP2015-93) (Order No. 2582), added July 14, 2015.

8. Priority Mail & First-Class Package Service Contract 6 (MC2015-63 and CP2015-94) (Order No. 2583), added July 15, 2015.

9. Priority Mail Contract 128 (MC2015-61 and CP2015-92) (Order No. 2592), added July 16, 2015.

10. Priority Mail Contract 130 (MC2015-64 and CP2015-95) (Order No. 2595), added July 17, 2015.

11. Priority Mail Contract 131 (MC2015-65 and CP2015-96) (Order No. 2596), added July 17, 2015.

12. Priority Mail Contract 132 (MC2015-66 and CP2015-97) (Order No. 2598), added July 17, 2015.

13. Priority Mail Contract 133 (MC2015-67 and CP2015-98) (Order No. 2600), added July 20, 2015.

14. Priority Mail Contract 135 (MC2015-71 and CP2015-109) (Order No. 2636), added August 4, 2015.

15. Priority Mail Contract 134 (MC2015-70 and CP2015-108) (Order No. 2637), added August 4, 2015.

16. Priority Mail Express & Priority Mail Contract 19 (MC2015-69 and CP2015-107) (Order No. 2638), added August 4, 2015.

17. Priority Mail Contract 138 (MC2015-74 and CP2015-112) (Order No. 2640), added August 5, 2015.

18. Priority Mail & First-Class Package Service Contract 7 (MC2015-75 and CP2015-114) (Order No. 2641), added August 5, 2015.

19. Priority Mail Contract 137 (MC2015-73 and CP2015-111) (Order No. 2642), added August 5, 2015.

20. Priority Mail Contract 136 (MC2015-72 and CP2015-110) (Order No. 2647), added August 10, 2015.

21. Priority Mail Contract 139 (MC2015-76 and CP2015-120) (Order No. 2651), added August 11, 2015.

22. Priority Mail Express Contract 26 (MC2015-77 and CP2015-121) (Order No. 2662), added August 13, 2015.

23. Priority Mail Express & Priority Mail Contract 20 (MC2015-78 and CP2015-123) (Order No. 2670), added August 18, 2015.

24. Priority Mail Contract 140 (MC2015-79 and CP2015-126) (Order No. 2680), added August 25, 2015.

25. Priority Mail Contract 141 (MC2015-80 and CP2015-134) (Order No. 2706), added September 14, 2015.

26. Priority Mail Express Contract 27 (MC2015-81 and CP2015-135) (Order No. 2707), added September 14, 2015.

The following negotiated service agreements have expired and are being deleted from the Mail Classification Schedule:

1. Express Mail Contract 12 (MC2012-36 and CP2012-44) (Order No. 1433).

2. Priority Mail Contract 39 (MC2012-37 and CP2012-45) (Order No. 1434).

3. Priority Mail Contract 41 (MC2012-39 and CP2012-47) (Order No. 1445).

4. First-Class Package Service Contract 8 (MC2012-27 and CP2012-36) (Order No. 1394).

5. First-Class Package Service Contract 9 (MC2012-28 and CP2012-37) (Order No. 1395).

6. First-Class Package Service Contract 10 (MC2012-35 and CP2012-43) (Order No. 1419).

7. First-Class Package Service Contract 11 (MC2012-40 and CP2012-48) (Order No. 1446).

8. First-Class Package Service Contract 12 (MC2012-41 and CP2012-49) (Order No. 1447).

9. First-Class Package Service Contract 13 (MC2012-42 and CP2012-50) (Order No. 1452).

10. First-Class Package Service Contract 14 (MC2012-43 and CP2012-51) (Order No. 1453).

11. First-Class Package Service Contract 15 (MC2012-45 and CP2012-53) (Order No. 1457).

Updated product lists. The referenced changes to the product lists are incorporated into 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule.

For the reasons discussed in the preamble, the Postal Regulatory Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0840 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 30, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0840, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of February 11, 2015 (80 FR 7559) (FRL-9921-94), 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 4F8269) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC. The petition requested that 40 CFR 180.561 be amended by establishing tolerances for residues of the fungicide, acibenzolar-S-methyl, in or on pome fruit, crop group 11-10 at 0.03 parts per million (ppm) and citrus fruit, crop group 10-10 at 0.01 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the tolerance for residues of acibenzolar-S-methyl in or on fruit, citrus, group 10-10 at 0.02 ppm. The reason for this change is explained in Unit IV.C.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for acibenzolar-S-methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acibenzolar-S-methyl 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. In subchronic and chronic oral studies in rats, dogs and mice, signs of mild regenerative hemolytic anemia were consistently observed in all three species. These signs frequently included decreased erythrocyte counts, decreased hemoglobin, decreased hematocrit, increased reticulocyte counts, increased hemosiderosis in the spleen, liver and/or bone marrow, extramedullary hematopoiesis in the spleen, and increased spleen weights in both males and females. A compensatory response (increased erythrocyte production) regularly followed the initial anemia. Additional toxic effects observed in these same studies included decreases in body weight, body weight gain and/or food consumption. No other significant treatment-related effects of toxicological concern were observed in these subchronic and chronic oral studies. In a 28-day dermal study in rats, no systemic or dermal effects were observed at dose levels up to 1,000 milligram (mg)/kilogram (kg)/day, the limit dose. No neurotoxic effects were observed at any dose in a subchronic neurotoxicity study in rats.

Treatment-related developmental malformations, anomalies and variations were observed in a developmental toxicity study in rats at or below the no observable adverse effect level (NOAEL) for maternal toxicity. At the highest dose tested in this study (400 mg/kg/day), both maternal toxicity (hemorrhagic perineal discharge) and considerable developmental toxicity (including total litter resorptions, fetal malformations, anomalies and variations) were observed. The fetal malformations noted at this dose included treatment-related effects on nervous system tissues (hydrocephaly, craniorachisis and anophthalmia/microphthalmia). At the next lower dose tested (200 mg/kg/day), treatment-related visceral malformations and skeletal variations were demonstrated in the absence of significant maternal toxicity. A similar increased sensitivity of fetuses or pups (as compared to adults) was not observed in a developmental toxicity study in rabbits or in 2-generation and 1-generation (range-finding) studies in rats. In a dermal developmental toxicity study in rats, no maternal or developmental toxicity was observed at dose levels up to 500 mg/kg/day, the highest dose tested.

In a battery of mutagenicity studies, results were negative in all studies except in an in vitro chromosome aberration study in Chinese hamster ovary (CHO) cells, in which there was evidence of a clastogenic response in the absence of S-9 activation.

In a 2-year chronic toxicity/carcinogenicity study in rats and an 18-month carcinogenicity study in mice, acibenzolar-S-methyl was negative for carcinogenicity when administered at dose levels adequate for the testing of carcinogenic potential.

Acibenzolar-S-methyl showed no significant toxicity in a battery of acute toxicity tests (Toxicity Category III or IV in all tests). Considerable skin sensitizing (contact allergenic) potential was demonstrated in a dermal sensitization study in guinea pigs for the technical grade material. The end-use product did not show dermal sensitization in guinea pigs.

Specific information on the studies received and the nature of the adverse effects caused by acibenzolar-S-methyl as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document titled “Acibenzolar-S-Methyl. A Human Health Risk Assessment to support Section 3 Use of Acibenzolar-S-Methyl Uses on Citrus Crop Group 10-10, and Pome Crop Group 11-10 at pages 39-44 in docket ID number EPA-HQ-OPP-2014-0840.

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 the NOAEL and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for acibenzolar-S-methyl used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acibenzolar-S-methyl, EPA considered exposure under the petitioned-for tolerances as well as all existing acibenzolar-S-methyl tolerances in 40 CFR 180.561. EPA assessed dietary exposures from acibenzolar-S-methyl 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 acibenzolar-S-methyl for females 13-49 years old and children 1-12 years old. No acute endpoint was identified for the general population/adults. In estimating acute dietary exposure, EPA used 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) 2003-2008. A probabilistic assessment was performed for the acute analysis. Foods were classified as blended, partially blended, or non-blended. The acute analysis assumed a distribution of residues based on field-trial data for non-blended and partially blended commodities. For blended commodities, the mean field-trial values were used as a point estimate. A value of 1/2 level of quantification (LOQ) was used for samples that contained less than LOQ residues. Time-limited tolerance values were used (0.05 ppm) for the Experimental Use Permit (EUP) commodities, i.e., apple, pear, and grapefruit. Section 3 tolerance-level residues were used for all other citrus and pome fruit commodities. Dietary Exposure Evaluation Model (DEEM) default processing factors were used for apple juice, cranberry juice, dried apples, dried pears, dried onion, dried banana, dried plantain, and dried tomato. Empirical processing factors were used for citrus juice (1.0), tomato paste (7.1), tomato puree (2.9), and tomato juice (1.0). Residues of acibenzolar-S-methyl did not concentrate in citrus juice or oil. The acute analysis used available maximum percent crop treated (MPCT) estimates and assumed 100 PCT for commodities for which no PCT data were available. Based on the lettuce metabolism data, a factor of 1.5X was applied to estimates of acibenzolar-S-methyl residues to account for all of the residues of concern for dietary risk (including CGA-210007, CGA-323060 and CGA-324041).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA NHANES/WEIA 2003-2008. A conservative chronic dietary exposure analysis was performed for the general U.S. population and various population subgroups. In the chronic dietary exposure analysis, tolerance-level residues were used and 100% CT was assumed for all commodities. Temporary tolerance values were used for apple, pear, and grapefruit, since they are higher that the new section 3 tolerances, and do not expire until 12/31/2015. Section 3 tolerance levels are used for all other crop group 10-10, and pome crop group 11-10 commodities. DEEM default processing factors were used for apple juice, dried apples, cranberry juice, dried apple, dried pears, dried onion, dried banana, dried plantain, and dried tomato. A processing factor was not used for tomato paste because a separate tolerance has been established for this processed commodity. In the submitted tomato processing study, processing factors of 1.0 and 2.9 were reported for tomato juice and tomato puree, respectively. These processing factors were used in the dietary exposure assessment. Residues of acibenzolar-S-methyl did not concentrate in citrus juice or oil based on a processing study, so a processing factor of 1.0 was used. A factor of 1.5X was applied to estimates of acibenzolar-S-methyl residues to account for all of the residues of concern for dietary risk (including CGA-210007, CGA-323060 and CGA-324041).

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

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

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

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

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

For the acute dietary analysis, EPA estimated PCT for the following crops for which uses of acibenzolar-S-methyl are currently registered based on available MPCT estimates: Broccoli: 10%; cabbage: 2.5%; cauliflower: 10%; lettuce: 10%; peppers: 10%; spinach: 50%; and tomatoes: 10%.

In the chronic dietary exposure analysis, 100% CT was assumed for all commodities.

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 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.

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

Surface water estimated drinking water concentrations (EDWCs) were generated for the total residues of acibenzolar and CGA 210007 using the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model for all proposed uses. Exposure in ground water due to leaching was assessed with the Pesticide Root Zone Model Ground Water (PRZM-GW). The EDWCs of acibenzolar-S-methyl for acute exposures are estimated to be 47.19 microgram per liter (µg/L) for surface water (citrus) and 13.33 µg/L for ground water. For chronic exposures (non-cancer) assessments the EDWC is 13.33 µg/L for surface water (apple).

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 47.19 µg/L was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 13.33 µg/L 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).

Acibenzolar-S-methyl is not being registered for any specific use patterns that would result in residential exposure in this action. However, a revised post-application residential exposure assessment was conducted to update the residential exposures based on the 2012 revised Residential SOPs.

There is the potential for post-application exposure for individuals exposed as a result of being in an environment that has been previously treated with acibenzolar-S-methyl. The quantitative exposure/risk assessment for residential post-application exposures is based on the following scenarios: Adult, 11 to <16 years old, and 6 to <11 years old dermal exposure from playing golf on treated golf courses (short-term dermal exposure).

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (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. In the rat developmental toxicity study, treatment-related visceral malformations and skeletal variations were observed in fetuses at 200 mg/kg/day, the NOAEL for maternal toxicity. In the developmental neurotoxicity study, offspring toxicity was observed at 82 mg/kg/day while no maternal toxicity was observed at 326 mg/kg/day, the highest dose tested. Additional developmental toxicity studies in rats and rabbits and reproduction studies in rats provided no indication of increased susceptibility of rat or rabbit fetuses or neonates compared to adult animals.

3. Conclusion. The FQPA factor for increased susceptibility to infants and children is reduced to 1x based on the following considerations.

i. The toxicology database for acibenzolar-S-methyl is complete and adequate for assessing increased susceptibility under FQPA. The pre- and postnatal toxicity database for acibenzolar-S-methyl includes developmental toxicity studies in rats and rabbits, a developmental neurotoxicity study (DNT) study in rats, and a 2-generation reproduction toxicity study in rats.

ii. There is some evidence of potential neurotoxicity in a developmental neurotoxicity study. Although there were no treatment-related offspring effects seen on survival, clinical signs, functional observational battery (FOB), developmental land marks, brain weights or neuropathology, significant morphometric changes (decreased thickness of the molecular layer of the cerebellum) were observed in male offspring on postnatal date (PND) 63 at 82 mg/kg/day. At the high dose, treatment-related offspring effects included decreased body weights, increased auditory startle response and increased thickness in the corpus callosum in females. No effects were observed in maternal animals at the highest dose tested. However, in a subchronic neurotoxicity study in rats, no compound-related effects were observed in the FOB, motor activity, gross pathology or neuropathology at the highest doses (575/628 mg/kg/day, male/female) tested.

iii. Based on the developmental toxicity in rats and the developmental neurotoxicity studies in rats, there is concern for increased qualitative and/or quantitative susceptibility following in utero exposure to acibenzolar-S-methyl. However, the degree of concern for the increased susceptibility seen in these studies is low, as there are no residual uncertainties with regard to pre- and/or postnatal toxicity since (1) NOAELs and LOAELs have been identified for all effects of concern, (2) a clear dose response has been well defined, and (3) the points of departure selected for risk assessment are protective of the fetal/offspring effects.

iv. There are no residual uncertainties identified in the exposure databases. The refined acute dietary assessment utilizes maximum percent crop treated estimates but is still considered conservative, since it is based on field trial data treated at the shorest preharvest interval and maximum use rate. The chronic dietary and residential risk assessments are also conservative. These assessments will not underestimate dietary and/or non-dietary residential exposure to acibenzolar-S-methyl. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acibenzolar-S-methyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure. These assessments will not underestimate the exposure and risks posed by acibenzolar-S-methyl.

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 acibenzolar-S-methyl will occupy 33% 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 acibenzolar-S-methyl from food and water will utilize 13% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). There is potential short-term exposure to acibenzolar-S-methyl via the dietary pathway and the residential pathway (golfing on treated golf courses). Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1,300 for children 6 to <11 years old. Because EPA's level of concern for acibenzolar-S-methyl is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Since the short- and intermediate-term PODs are the same and short-term exposure estimates are greater than their intermediate-term counterparts, the short-term aggregate risk assessment is protective of the intermediate-term aggregate exposure.

5. Aggregate cancer risk for U.S. population. An aggregate cancer risk was not calculated because acibenzolar-S-methyl was classified as “not likely to be carcinogenic to humans”.

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

HPLC/UV Method AG-617A is available for tolerance enforcement. The method consists of an initial hydrolysis with NaOH to convert acibenzolar-S-methyl to CGA-210007 followed by methanol extraction. Residues are then diluted with HCl and purified by a series of solid-phase extraction steps. Prior to HPLC/UV analysis, residues are partitioned into ethyl acetate, dried down, and re-dissolved in phosphoric acid. This method has a LOQ of 0.02 ppm. The method includes optional detection via HPLC/MS, giving a means of residue confirmation.

The method 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 acibenzolar-S-methyl.

The tolerance level for fruit, citrus, group 10-10 (0.02 ppm) is being set at the LOQ of the enforcement method which is higher than the petitioned-for tolerance (0.01 ppm). The names of the crop groups for citrus and pome fruit are being corrected to fruit, citrus, group 10-10 and fruit, pome, group 11-10.

Therefore, tolerances are established for residues of acibenzolar-S-methyl, fungicide, in or on fruit, citrus, group 10-10 at 0.02 ppm and fruit, pome, group 11-10 at 0.03 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:

In 1980, Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601-9675 (“CERCLA” or “the Act”), in response to the dangers of uncontrolled releases or threatened releases of hazardous substances, and releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. CERCLA was amended on October 17, 1986, by the Superfund Amendments and Reauthorization Act (“SARA”), Public Law 99-499, 100 Stat. 1613 et seq.

To implement CERCLA, the EPA promulgated the revised National Oil and Hazardous Substances Pollution Contingency Plan (“NCP”), 40 CFR part 300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets guidelines and procedures for responding to releases and threatened releases of hazardous substances, or releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. The EPA has revised the NCP on several occasions. The most recent comprehensive revision was on March 8, 1990 (55 FR 8666).

As required under section 105(a)(8)(A) of CERCLA, the NCP also includes “criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial action and, to the extent practicable, taking into account the potential urgency of such action, for the purpose of taking removal action.” “Removal” actions are defined broadly and include a wide range of actions taken to study, clean up, prevent or otherwise address releases and threatened releases of hazardous substances, pollutants or contaminants (42 U.S.C. 9601(23)).

The NPL is a list of national priorities among the known or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The list, which is appendix B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B) of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list of “releases” and the highest priority “facilities” and requires that the NPL be revised at least annually. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance, however, as it does not assign liability to any party or to the owner of any specific property. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

For purposes of listing, the NPL includes two sections, one of sites that are generally evaluated and cleaned up by the EPA (the “General Superfund section”) and one of sites that are owned or operated by other federal agencies (the “Federal Facilities section”). With respect to sites in the Federal Facilities section, these sites are generally being addressed by other federal agencies. Under Executive Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each federal agency is responsible for carrying out most response actions at facilities under its own jurisdiction, custody or control, although the EPA is responsible for preparing a Hazard Ranking System (“HRS”) score and determining whether the facility is placed on the NPL.

There are three mechanisms for placing sites on the NPL for possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site may be included on the NPL if it scores sufficiently high on the HRS, which the EPA promulgated as appendix A of the NCP (40 CFR part 300). The HRS serves as a screening tool to evaluate the relative potential of uncontrolled hazardous substances, pollutants or contaminants to pose a threat to human health or the environment. On December 14, 1990 (55 FR 51532), the EPA promulgated revisions to the HRS partly in response to CERCLA section 105(c), added by SARA. The revised HRS evaluates four pathways: Ground water, surface water, soil exposure and air. As a matter of agency policy, those sites that score 28.50 or greater on the HRS are eligible for the NPL. (2) Each state may designate a single site as its top priority to be listed on the NPL, without any HRS score. This provision of CERCLA requires that, to the extent practicable, the NPL include one facility designated by each state as the greatest danger to public health, welfare or the environment among known facilities in the state. This mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2). (3) The third mechanism for listing, included in the NCP at 40 CFR 300.425(c)(3), allows certain sites to be listed without any HRS score, if all of the following conditions are met:

(1) The Agency for Toxic Substances and Disease Registry (ATSDR) of the U.S. Public Health Service has issued a health advisory that recommends dissociation of individuals from the release.

(2) The EPA determines that the release poses a significant threat to public health.

(3) The EPA anticipates that it will be more cost-effective to use its remedial authority than to use its removal authority to respond to the release.

The EPA promulgated an original NPL of 406 sites on September 8, 1983 (48 FR 40658) and generally has updated it at least annually.

A site may undergo remedial action financed by the Trust Fund established under CERCLA (commonly referred to as the “Superfund”) only after it is placed on the NPL, as provided in the NCP at 40 CFR 300.425(b)(1). (“Remedial actions” are those “consistent with a permanent remedy, taken instead of or in addition to removal actions” (40 CFR 300.5). However, under 40 CFR 300.425(b)(2), placing a site on the NPL “does not imply that monies will be expended.” The EPA may pursue other appropriate authorities to respond to the releases, including enforcement action under CERCLA and other laws.

The NPL does not describe releases in precise geographical terms; it would be neither feasible nor consistent with the limited purpose of the NPL (to identify releases that are priorities for further evaluation), for it to do so. Indeed, the precise nature and extent of the site are typically not known at the time of listing.

Although a CERCLA “facility” is broadly defined to include any area where a hazardous substance has “come to be located” (CERCLA section 101(9)), the listing process itself is not intended to define or reflect the boundaries of such facilities or releases. Of course, HRS data (if the HRS is used to list a site) upon which the NPL placement was based will, to some extent, describe the release(s) at issue. That is, the NPL site would include all releases evaluated as part of that HRS analysis.

When a site is listed, the approach generally used to describe the relevant release(s) is to delineate a geographical area (usually the area within an installation or plant boundaries) and identify the site by reference to that area. However, the NPL site is not necessarily coextensive with the boundaries of the installation or plant, and the boundaries of the installation or plant are not necessarily the “boundaries” of the site. Rather, the site consists of all contaminated areas within the area used to identify the site, as well as any other location where that contamination has come to be located, or from where that contamination came.

In other words, while geographic terms are often used to designate the site (e.g., the “Jones Co. Plant site”) in terms of the property owned by a particular party, the site, properly understood, is not limited to that property (e.g., it may extend beyond the property due to contaminant migration), and conversely may not occupy the full extent of the property (e.g., where there are uncontaminated parts of the identified property, they may not be, strictly speaking, part of the “site”). The “site” is thus neither equal to, nor confined by, the boundaries of any specific property that may give the site its name, and the name itself should not be read to imply that this site is coextensive with the entire area within the property boundary of the installation or plant. In addition, the site name is merely used to help identify the geographic location of the contamination, and is not meant to constitute any determination of liability at a site. For example, the name “Jones Co. plant site,” does not imply that the Jones Company is responsible for the contamination located on the plant site.

EPA regulations provide that the remedial investigation (“RI”) “is a process undertaken * * * to determine the nature and extent of the problem presented by the release” as more information is developed on site contamination, and which is generally performed in an interactive fashion with the feasibility study (“FS”) (40 CFR 300.5). During the RI/FS process, the release may be found to be larger or smaller than was originally thought, as more is learned about the source(s) and the migration of the contamination. However, the HRS inquiry focuses on an evaluation of the threat posed and therefore the boundaries of the release need not be exactly defined. Moreover, it generally is impossible to discover the full extent of where the contamination “has come to be located” before all necessary studies and remedial work are completed at a site. Indeed, the known boundaries of the contamination can be expected to change over time. Thus, in most cases, it may be impossible to describe the boundaries of a release with absolute certainty.

Further, as noted above, NPL listing does not assign liability to any party or to the owner of any specific property. Thus, if a party does not believe it is liable for releases on discrete parcels of property, it can submit supporting information to the agency at any time after it receives notice it is a potentially responsible party.

For these reasons, the NPL need not be amended as further research reveals more information about the location of the contamination or release.

The EPA may delete sites from the NPL where no further response is appropriate under Superfund, as explained in the NCP at 40 CFR 300.425(e). This section also provides that the EPA shall consult with states on proposed deletions and shall consider whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required;

(ii) All appropriate Superfund-financed response has been implemented and no further response action is required; or

(iii) The remedial investigation has shown the release poses no significant threat to public health or the environment, and taking of remedial measures is not appropriate.

In November 1995, the EPA initiated a policy to delete portions of NPL sites where cleanup is complete (60 FR 55465, November 1, 1995). Total site cleanup may take many years, while portions of the site may have been cleaned up and made available for productive use.

The EPA also has developed an NPL construction completion list (“CCL”) to simplify its system of categorizing sites and to better communicate the successful completion of cleanup activities (58 FR 12142, March 2, 1993). Inclusion of a site on the CCL has no legal significance.

Sites qualify for the CCL when: (1) Any necessary physical construction is complete, whether or not final cleanup levels or other requirements have been achieved; (2) the EPA has determined that the response action should be limited to measures that do not involve construction (e.g., institutional controls); or (3) the site qualifies for deletion from the NPL. For the most up-to-date information on the CCL, see the EPA's Internet site at http://www.epa.gov/superfund/cleanup/ccl.htm.

The Sitewide Ready for Anticipated Use measure represents important Superfund accomplishments and the measure reflects the high priority the EPA places on considering anticipated future land use as part of the remedy selection process. See Guidance for Implementing the Sitewide Ready-for-Reuse Measure, May 24, 2006, OSWER 9365.0-36. This measure applies to final and deleted sites where construction is complete, all cleanup goals have been achieved, and all institutional or other controls are in place. The EPA has been successful on many occasions in carrying out remedial actions that ensure protectiveness of human health and the environment for current and future land uses, in a manner that allows contaminated properties to be restored to environmental and economic vitality. For further information, please go to http://www.epa.gov/superfund/programs/recycle/pdf/sitewide_a.pdf.

In order to maintain close coordination with states and tribes in the NPL listing decision process, the EPA's policy is to determine the position of the states and tribes regarding sites that the EPA is considering for listing. This consultation process is outlined in two memoranda that can be found at the following Web site: http://www.epa.gov/superfund/sites/npl/hrsres/policy/govlet.pdf. The EPA has improved the transparency of the process by which state and tribal input is solicited. The EPA is using the Web and where appropriate more structured state and tribal correspondence that (1) explains the concerns at the site and the EPA's rationale for proceeding; (2) requests an explanation of how the state intends to address the site if placement on the NPL is not favored; and (3) emphasizes the transparent nature of the process by informing states that information on their responses will be publicly available.

A model letter and correspondence between the EPA and states and tribes where applicable, is available on the EPA's Web site at http://www.epa.gov/superfund/sites/query/queryhtm/nplstcor.htm.

Yes, documents relating to the evaluation and scoring of the sites in this final rule are contained in dockets located both at the EPA headquarters and in the EPA regional offices.

An electronic version of the public docket is available through http://www.regulations.gov (see table below for docket identification numbers). Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facilities identified below in section II D.

The headquarters docket for this rule contains the HRS score sheets, the documentation record describing the information used to compute the score and a list of documents referenced in the documentation record for each site.

The EPA regional dockets contain all the information in the headquarters docket, plus the actual reference documents containing the data principally relied upon by the EPA in calculating or evaluating the HRS score. These reference documents are available only in the regional dockets.

You may view the documents, by appointment only, after the publication of this rule. The hours of operation for the headquarters docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding federal holidays. Please contact the regional dockets for hours. For addresses for the headquarters and regional dockets, see “ADDRESSES” section in the beginning portion of this preamble.

You may obtain a current list of NPL sites via the Internet at http://www.epa.gov/superfund/sites/npl/index.htm or by contacting the Superfund docket (see contact information in the beginning portion of this document).

This final rule adds the following five sites to the General Superfund section of the NPL. These sites are being added to the NPL based on HRS score.

General Superfund section:

The EPA is adding five sites to the NPL in this final rule, all to the general Superfund section. All of the sites were proposed for addition to the NPL on March 26, 2015 (80 FR 15972).

Four of the sites received no comments. They are BJAT LLC in Franklin, MA; Estech General Chemical Company in Calumet City, IL; Colonial Creosote in Bogalusa, LA; and Main Street Ground Water Plume in Burnet, TX. Although two comments were erroneously submitted to the docket for Colonial Creosote along with two erroneous comments for Main Street Ground Water Plume, all four comments related to the Anaconda Aluminum Co Columbia Falls Reduction Plant. Those comments will be addressed at the time a decision is made on the Anaconda Aluminum Co Columbia Falls Reduction Plant site.

Extensive comments were submitted for the Grain Handling Facility at Freeman in Freeman, WA. Those comments have been addressed in a response to comments support document available in the public docket concurrently with the publication of this rule.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose an information collection burden under the PRA. This rule does not contain any information collection requirements that require approval of the OMB.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This rule listing sites on the NPL does not impose any obligations on any group, including small entities. This rule also does not establish standards or requirements that any small entity must meet, and imposes no direct costs on any small entity. Whether an entity, small or otherwise, is liable for response costs for a release of hazardous substances depends on whether that entity is liable under CERCLA 107(a). Any such liability exists regardless of whether the site is listed on the NPL through this rulemaking.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments or the private sector. Listing a site on the NPL does not itself impose any costs. Listing does not mean that the EPA necessarily will undertake remedial action. Nor does listing require any action by a private party, state, local or tribal governments or determine liability for response costs. Costs that arise out of site responses result from future site-specific decisions regarding what actions to take, not directly from the act of placing a site on the NPL.

This final rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. Listing a site on the NPL does not impose any costs on a tribe or require a tribe to take remedial action. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because this action itself is procedural in nature (adds sites to a list) and does not, in and of itself, provide protection from environmental health and safety risks. Separate future regulatory actions are required for mitigation of environmental health and safety risks.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. As discussed in Section I.C. of the preamble to this action, the NPL is a list of national priorities. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance as it does not assign liability to any party. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Provisions of the Congressional Review Act (CRA) or section 305 of CERCLA may alter the effective date of this regulation. Under 5 U.S.C. 801(b)(1), a rule shall not take effect, or continue in effect, if Congress enacts (and the President signs) a joint resolution of disapproval, described under section 802. Another statutory provision that may affect this rule is CERCLA section 305, which provides for a legislative veto of regulations promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S. Ct. 2764 (1983), and Bd. of Regents of the University of Washington v. EPA, 86 F.3d 1214,1222 (D.C. Cir. 1996), cast the validity of the legislative veto into question, the EPA has transmitted a copy of this regulation to the Secretary of the Senate and the Clerk of the House of Representatives.

If action by Congress under either the CRA or CERCLA section 305 calls the effective date of this regulation into question, the EPA will publish a document of clarification in the Federal Register.

40 CFR part 300 is amended as follows:

I. Background

The BLM has specific authority to charge fees for processing applications and other documents relating to public lands under section 304 of the Federal Land Policy and Management Act of 1976 (FLPMA), 43 U.S.C. 1734. In 2005, the BLM published a final cost recovery rule (70 FR 58854) establishing or revising certain fees and service charges, and establishing the method it would use to adjust those fees and service charges on an annual basis.

At 43 CFR 3000.12(a), the regulations provide that the BLM will annually adjust fees established in Subchapter C (43 CFR parts 3000-3900) according to changes in the Implicit Price Deflator for Gross Domestic Product (IPD-GDP), which is published quarterly by the U.S. Department of Commerce. See also 43 CFR 3000.10. This final rule will allow the BLM to update these fees and service charges by October 1 of this year, as required by the 2005 regulation. The fee recalculations are based on a mathematical formula. The public had an opportunity to comment on this procedure during the comment period on the 2005 cost recovery rule, and this new rule administers the procedure set forth in those regulations. Therefore, the BLM has changed the fees in this final rule without providing opportunity for additional notice and comment. See 43 CFR 3000.10(c). Accordingly, the Department of the Interior for good cause finds under 5 U.S.C. 553(b)(B) and (d)(3) that notice and public comment procedures are unnecessary and that the rule may be effective less than 30 days after publication.

The BLM publishes a fee update rule each year, which becomes effective on October 1 of that year. The fee updates are based on the change in the IPD-GDP from the 4th Quarter of one calendar year to the 4th Quarter of the following calendar year. This fee update rule is based on the change in the IPD-GDP from the 4th Quarter of 2013 to the 4th Quarter of 2014, thus reflecting the rate of inflation over four calendar quarters.

The fee is calculated by applying the IPD-GDP to the base value from the previous year's rule, also known as the “existing value.” This calculation results in an updated base value. The updated base value is then rounded to the closest multiple of $5 for fees equal to or greater than $1, or to the nearest cent for fees under $1, to establish the new fee.

Under this rule, 34 fees will remain the same and 14 fees will increase. Of the fees that will be increased, 12 of the fee increases will amount to $5 each. The largest increase, $40, will be applied to the fee for adjudicating a mineral patent application containing more than 10 claims, and will increase the fee from $3,035 to $3,075. The fee for adjudicating a patent application containing 10 or fewer claims will increase by $15, from $1,520 to $1,535.

The calculations that resulted in the new fees are included in the table below:

Each year, the figures in the Existing Value column in the table above (not those in the Existing Fee column) are used as the basis for calculating the adjustment to these fees. The Existing Value is the figure from the New Value column in the previous year's rule. In the case of fees that were not in the table the previous year, or that had no figure in the New Value column the previous year, the Existing Value is the same as the Existing Fee. Because the new fees are derived from the new values, adjustments based on the figures in the Existing Fee column would lead to significantly over- or under-valued fees over time. Accordingly, fee adjustments are made by multiplying the annual change in the IPD-GDP by the figure in the Existing Value column. This calculation defines the New Value for this year, which is then rounded to the nearest $5 for fees equal to or greater than $1 or the nearest penny for fees under $1 to establish the New Fee.

This document is not a significant rule, and the Office of Management and Budget has not reviewed this rule under Executive Order 12866.

The BLM has determined that the rule will not have an annual effect on the economy of $100 million or more. It will not adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The changes in today's rule are much smaller than those in the 2005 final rule, which did not approach the threshold in Executive Order 12866. For instructions on how to view a copy of the analysis prepared in conjunction with the 2005 final rule, please contact one of the persons listed in the FOR FURTHER INFORMATION CONTACT section above.

This rule will not create inconsistencies or otherwise interfere with an action taken or planned by another agency. This rule does not change the relationships of the onshore minerals programs with other agencies' actions. These relationships are included in agreements and memoranda of understanding that would not change with this rule.

In addition, this final rule does not materially affect the budgetary impact of entitlements, grants, or loan programs, or the rights and obligations of their recipients. This rule applies an inflation factor that increases some existing user fees for processing documents associated with the onshore minerals programs. However, most of these fee increases are less than 2 percent, and none of the increases materially affect the budgetary impact of user fees.

Finally, this rule will not raise novel legal or policy issues. As explained above, this rule simply implements an annual process to account for inflation that was adopted by and explained in the 2005 cost recovery rule.

This final rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). A Regulatory Flexibility Analysis is not required. For the purposes of this section, a small entity is defined by the Small Business Administration (SBA) for mining (broadly inclusive of metal mining, coal mining, oil and gas extraction, and the mining and quarrying of nonmetallic minerals) as an individual, limited partnership, or small company considered to be at arm's length from the control of any parent companies, with fewer than 500 employees. The SBA defines a small entity differently, however, for leasing Federal land for coal mining. A coal lessee is a small entity if it employs not more than 250 people, including people working for its affiliates.

The SBA would consider many, if not most, of the operators the BLM works with in the onshore minerals programs to be small entities. The BLM notes that this final rule does not affect service industries, for which the SBA has a different definition of “small entity.”

The final rule may affect a large number of small entities since 14 fees for activities on public lands will be increased. However, the BLM has concluded that the effects will not be significant. Most of the fixed fee increases will be less than 2 percent as a result of this final rule. The adjustments result in no increase in the fee for the processing of 34 documents relating to the BLM's minerals programs. The highest adjustment, in dollar terms, is for adjudications of mineral patent applications involving more than 10 mining claims, which will be increased by $40. For the 2005 final rule, the BLM completed a Regulatory Flexibility Act threshold analysis, which is available for public review in the administrative record for that rule. For instructions on how to view a copy of that analysis, please contact one of the persons listed in the FOR FURTHER INFORMATION CONTACT section above. The analysis for the 2005 rule concluded that the fees would not have a significant economic effect on a substantial number of small entities. The fee increases implemented in today's rule are substantially smaller than those provided for in the 2005 rule.

This final rule is not a “major rule” as defined at 5 U.S.C. 804(2). The final rule will not have an annual effect on the economy greater than $100 million; it will not result in major cost or price increases for consumers, industries, government agencies, or regions; and it will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. For the 2005 final rule, which established the fee adjustment procedure that this rule implements, the BLM completed a threshold analysis, which is available for public review in the administrative record for that rule. The fee increases implemented in today's rule are substantially smaller than those provided for in the 2005 rule. Accordingly, a Small Entity Compliance Guide is not required.

This final rule 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. In accordance with Executive Order 13132, therefore, we find that the final rule does not have federalism implications. A federalism assessment is not required.

This rule does not contain information collection requirements that require a control number from the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). After the effective date of this rule, the new fees may affect the non-hour burdens associated with the following control numbers:

(1) 1004-0034 which expires July 31, 2018;

(2) 1004-0137 which expires January 31, 2018;

(3) 1004-0162 which expires September 30, 2015;

(4) 1004-0185 which expires December 31, 2015;

(5) 1004-0132 which expires December 31, 2016;

(6) 1004-0073 which expires August 31, 2016;

(7) 1004-0025 which expires March 31, 2016;

(8) 1004-0114 which expires October 31, 2016; and

(9) 1004-0121 which expires March 31, 2016.

As required by Executive Order 12630, the BLM has determined that this rule will not cause a taking of private property. No private property rights will be affected by a rule that merely updates fees. The BLM therefore certifies that this final rule does not represent a governmental action capable of interference with constitutionally protected property rights.

In accordance with Executive Order 12988, the BLM finds that this final rule will not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order.

The BLM has determined that this final rule qualifies as a routine financial transaction and a regulation of an administrative, financial, legal, or procedural nature that is categorically excluded from environmental review under NEPA pursuant to 43 CFR 46.205 and 46.210(c) and (i). The final rule does not meet any of the 12 criteria for exceptions to categorical exclusions listed at 43 CFR 46.215.

Pursuant to Council on Environmental Quality (CEQ) regulations, the term “categorical exclusions” means categories of actions “which do not individually or cumulatively have a significant effect on the human environment and which have been found to have no such effect in procedures adopted by a federal agency in implementation of [CEQ] regulations (§ 1507.3) and for which, therefore, neither an environmental assessment nor an environmental impact statement is required.” 40 CFR 1508.4.

The BLM has determined that this final rule is not significant under the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 et seq., because it will not result in State, local, private sector, or tribal government expenditures of $100 million or more in any one year, 2 U.S.C. 1532. This rule will not significantly or uniquely affect small governments. Therefore, the BLM is not required to prepare a statement containing the information required by the Unfunded Mandates Reform Act.

In accordance with Executive Order 13175, the BLM has determined that this final rule does not include policies that have tribal implications. Specifically, the rule would not have substantial direct effects on one or more Indian tribes. Consequently, the BLM did not utilize the consultation process set forth in Section 5 of the Executive Order.

In developing this rule, the BLM did not conduct or use a study, experiment, or survey requiring peer review under the Information Quality Act (Pub. L. 106-554).

In accordance with Executive Order 13211, the BLM has determined that this final rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It merely adjusts certain administrative cost recovery fees to account for inflation.

The principal author of this rule is Mark Purdy of the Division of Regulatory Affairs, Bureau of Land Management.

For reasons stated in the preamble, the Bureau of Land Management amends 43 CFR part 3000 as follows:

I. Background

DoD is amending the numbering structure for various sections in DFARS subpart 232.6 and revising section headings, where appropriate, in order to conform with the FAR. This change will align the DFARS with the same coverage in the FAR. No changes are made beyond the redesignation of DFARS subpart 232.6 section numbers and the conformation of DFARS section headings to the FAR.

“Publication of proposed regulations”, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation. Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because the DFARS sections are being renumbered merely to conform to the FAR sections and the DFARS section titles are being modified to conform to the FAR section titles. The content of the DFARS sections remains unchanged. This will alleviate any confusion the contracting officers may have and aid in moving between the two regulations with ease. These requirements affect only the internal operating procedures of the Government.

Executive Orders (E.O.s) 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, was not 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.

The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant DFARS revision within the meaning of FAR 1.501-1, and 41 U.S.C. 1707 does not require publication for public comment.

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).

Therefore, 48 CFR part 232 is amended as follows:

I. Background

On March 11, 2015, PHMSA published a final rule amending the pipeline safety regulations to make miscellaneous changes that update and clarify certain regulatory requirements (80 FR 12762). These amendments address several subject matter areas, including the performance of post-construction inspections, Type B onshore gas gathering line leak surveys, qualifying plastic pipe joiners, ethanol regulation, pipe transportation, offshore pipeline condition report filing, pressure reduction calculations for hazardous liquid pipeline anomalies, and components fabricated by welding.

Collectively, PHMSA received four petitions for reconsideration of the final rule from the American Public Gas Association (APGA), the American Gas Association (AGA), the Interstate Natural Gas Association (INGAA), and the National Association of Pipeline Safety Representatives (NAPSR). The APGA, the AGA, and NAPSR expressed concerns about the provisions of the final rule applicable to construction inspection in § 192.305. INGAA and the AGA expressed concerns applicable to provisions in the final rule applicable to components fabricated by welding.

In the final rule published on March 11, 2015, PHMSA added paragraph (e) to § 192.153 requiring that “a component having a design pressure established under paragraph (a) or paragraph (b) of this section and subject to the strength testing requirements of § 192.505(b) must be tested to at least 1.5 times the MAOP.” PHMSA also modified § 192.165(b)(3) to cross-reference this new subsection. In the preamble to the final rule, PHMSA noted “this proposal is not a change to the current pressure testing requirements found in Part 192, but [is] simply a clarification to ensure a clearer understanding of PHMSA's pressure testing requirements for certain ASME BPVC vessels located in compressor stations, meter stations and other Class 3 or Class 4 locations” (80 FR 12772, March 11, 2015).

On April 10, 2015, INGAA and AGA filed separate petitions for reconsideration with PHMSA regarding this change (Docket No. PHMSA-2010-0026). INGAA stated that PHMSA's modifications to these code sections were not merely a clarification, but a departure from industry and agency understanding and practice, and require additional review. Specifically, INGAA claimed that PHMSA changed the acceptable test factor for a pressure vessel built under the American Society or Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (BPVC) from the ASME requirements of 1.3 times the Maximum Allowable Working Pressure (MAWP) to 1.5 times the Maximum Allowable Operating Pressure (MAOP).

INGAA and AGA requested that PHMSA reconsider this change due to a lack of technical justification and regulatory support, asking PHMSA to, at a minimum, conduct a study to validate the future use of 1.5 times MAOP for ASME pressure vessels and create an exception for ASME pressure vessels that were put into operation between July 14, 2004 (when the 1.3 factor was adopted by ASME) and October 1, 2015 (the final rule's effective date).

After reviewing INGAA's and AGA's petitions for reconsideration, the language in the final rule, and the Pipeline Safety Regulations (PSR), PHMSA disagrees with the petitioners' claim that the change, as written, was a departure from industry and agency understanding. The pressure testing requirements in the PSR for pipelines in Class 3 and 4 areas, as well as facilities located in Class 1 and 2 areas, are subject to the requirements of § 192.505(b) and require a pressure test equal to a minimum of 1.5 times the MAOP. The testing requirements of § 192.505(b), which were not revised in the final rule, state that in a Class 1 or Class 2 location, each compressor station, regulator station, and measuring station must be tested to at least Class 3 location test requirements. PHMSA believes the amendment to § 192.153 and the corresponding cross-reference with § 192.165(b)(3) simply clarify the regulations, is consistent with existing agency understanding and practice, and ensures regulated parties do not incorrectly use the newer ASME BPVC design factor of 1.3 for pressure testing in instances where pipelines must be tested at 1.5 times MAOP.

Regarding INGAA's request to create an exception for ASME pressure vessels put into operation between July 14, 2004, and October 1, 2015, from the requirements found at § 192.153(e), PHMSA is considering INGAA's request and will be evaluating the potential costs and environmental implications to operators to retest the non-compliant pressure vessels.

Prior to the issuance of the final rule on March 11, 2015, § 192.305 stated that “each transmission pipeline or main must be inspected to ensure that it is constructed in accordance with this part,” and § 195.204 stated “inspection must be provided to ensure the installation of pipe or pipeline systems in accordance with the requirements of this subpart.” In the final rule issued on March 11, 2015, PHMSA amended § 192.305 to specify that a pipeline operator must not use operator personnel to perform a required inspection if the operator personnel also performed the construction task that required inspection. This amendment was based, in part, on a petition (Docket No. PHMSA-2010-0026) from the National Association of Pipeline Safety Representatives (NAPSR),1 which suggested that contractors who install transmission lines or mains should be prohibited from inspecting their own work for compliance purposes. On Wednesday, July 11, 2012, the Gas Pipeline Advisory Committee recommended that PHMSA adopt the amendment.

On April 10, 2015, the APGA petitioned for a clarification, or in the alternative, a reconsideration of the final rule. The APGA stated that the amendment to § 192.305 has the potential to impose significant costs on publicly-owned gas distribution systems with little, if any, corresponding safety benefit. The APGA stated that if a utility has only one qualified crew that works together to construct distribution mains, there would not be anyone working for the utility available and qualified to perform the inspection. According to the APGA, 585 municipal gas utilities have 5 or fewer employees. The APGA went on to say that prohibiting small utilities from having their own employees inspect pipeline construction work performed by employees of the municipal utility would significantly increase the costs for those utilities by requiring small utilities to contract with third parties for such inspections. The APGA stated that its concerns would be alleviated by a clarification stating a two-man utility crew may inspect each other's work and comply with the amendment to § 192.305.

On April 10, 2015, the AGA petitioned PHMSA to extend the compliance date for the amendments in § 192.305 and § 195.204 from October 1, 2015, to January 1, 2016. The AGA asked for this additional time to allow pipeline operators to modify their construction inspection procedures, align associated documentation, and ensure proper training is in place for both company employees and contractors.

On July 28, 2015, NAPSR petitioned PHMSA to reconsider the revision of § 192.305, as it undermines the 2002 NAPSR CR-1-02 resolution. NAPSR asked for a delay in the effective date of the final rule relative to § 192.305 until PHMSA has reviewed the rule and worked with NAPSR to address its concerns. According to NAPSR, allowing contractor personnel to inspect the work performed by their own company does not remove the inherent conflict of interest that is present and defeats the safety benefits that NAPSR intended. NAPSR stated that its original resolution would have prohibited contractors from self-inspecting their own work. NAPSR noted that, unfortunately, the final rule's amendment specifically allows contract personnel to inspect the work of their own crews so long as the inspector did not directly perform the task being inspected. Additionally, the amendment appears to apply to operator construction personnel as well, which was not NAPSR's original intent since, in its experience, operator personnel have less of an incentive to accept poor-quality work. Further, the final rule mistakenly decreases the scope of the inspection by changing the inspection requirements to only those found in Subpart G for the construction of mains and transmission lines,, rather than in all of Part 192 as it was prior to the amendment.

As stated in the final rule, PHMSA believes that these construction inspections are important safety requirements because transmission pipelines and distribution mains are usually buried after construction, and subsequent examinations of these pipelines often involve a difficult excavation process. Upon further examination of the impacts of this amendment, in particular the issues raised by the petitioners, PHMSA believes that further examination and analysis of this safety issue is warranted prior to this change going into effect. Therefore, PHMSA is delaying the effective date of the amendment to 49 CFR 192.305 indefinitely. During this delay, PHMSA will be evaluating the ways operators are currently complying with § 192.305, developing guidance (based on input from industry and other regulatory bodies) and hosting a series of workshops on the guidance. Upon completion of this evaluation, PHMSA will determine the efficacy of the amendment and decide if any additional amendments to the current regulations are warranted and to propose any necessary amendments to § 192.305. Please note, the effective date for all the other amendments contained in the final rule remains October 1, 2015.

This final rule is a non-significant regulatory action under section 3(f) of Executive Order 12866 (58 FR 51735) and therefore was not reviewed by the Office of Management and Budget. This final rule is not significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034).

This final rule will not impose increased compliance costs on the regulated industry. The amendments to the March 11, 2015 final rule provide regulatory relief to pipeline operators involved in construction inspection and do not alter the cost benefit analysis and conclusions.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), PHMSA must consider whether rulemaking actions would have a significant economic impact on a substantial number of small entities. This final rule will not impose increased compliance costs on the regulated industry. The delay in the effective date to § 192.305 does not alter our original certification that the March 11, 2015 final rule does not have a significant impact on a substantial number of small entities. Therefore, I certify under Section 605 of the Regulatory Flexibility Act (5 U.S.C. 605) that this final rule will not have a significant economic impact on a substantial number of small entities.

This final rule imposes no new requirements for recordkeeping and reporting.

This final rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It would not result in costs of $100 million, adjusted for inflation, or more in any one year to either State, local, or tribal governments, in the aggregate, or to the private sector, and is the least burdensome alternative that achieves the objective of the final rule.

The National Environmental Policy Act (42 U.S.C. 4321-4375) requires that Federal agencies analyze final actions to determine whether those actions will have a significant impact on the human environment. The Council on Environmental Quality regulations requires Federal agencies to conduct an environmental review considering (1) the need for the final action, (2) alternatives to the final action, (3) probable environmental impacts of the final action and alternatives, and (4) the agencies and persons consulted during the consideration process. 40 CFR 1508.9(b).

The amendment adopted in this final rule will not impose increased compliance costs on the regulated industry or have any measureable effect on our original assessment. The amendments to the March 11, 2015, final rule provide regulatory relief to pipeline operators involved in construction inspection. Overall, this final rule will reduce the compliance burden without compromising pipeline safety. Therefore, PHMSA has determined that this final rule will not have a significant impact on the human environment.

Anyone may search the electronic form of all comments received for any of our dockets. You may review DOT's complete Privacy Act Statement published in the Federal Register on April 11, 2000 (70 FR 19477).

PHMSA has analyzed this final rule according to Executive Order 13132 (“Federalism”). This final rule does not have a substantial direct effect on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. This final rule does not impose substantial direct compliance costs on State and local governments. This final rule does not preempt State law for intrastate pipelines. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

This final rule is not a “significant energy action” under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). It is not likely to have a significant adverse effect on supply, distribution, or energy use. Further, the Office of Information and Regulatory Affairs has not designated this final rule as a significant energy action.

The effective date for the amendment revising 49 CFR 192.305, published March 11, 2015, at 80 FR 12779, is delayed indefinitely.