Federal Register Vol. 81, No.105,

Background

The existing rules that are the subject of these corrections are part of the continuing series of regulations that the Commission has promulgated to implement the Presidential Election Campaign Fund Act, 26 U.S.C. 9001-13, and the Presidential Primary Matching Payment Account Act, 26 U.S.C. 9031-42 (collectively, the “Funding Acts”), and the Federal Election Campaign Act, 52 U.S.C. 30101-46 (“FECA”). The Commission is promulgating these corrections without advance notice or an opportunity for comment because they fall under the “good cause” exemption of the Administrative Procedure Act. 5 U.S.C. 553(b)(B). The Commission finds that notice and comment are unnecessary here because these corrections are merely typographical and technical; they effect no substantive changes to any rule. For the same reason, these corrections fall within the “good cause” exception to the delayed effective date provisions of the Administrative Procedure Act and the Congressional Review Act. 5 U.S.C. 553(d)(3), 808(2).

Moreover, because these corrections are exempt from the notice and comment procedure of the Administrative Procedure Act under 5 U.S.C. 553(b), the Commission is not required to conduct a regulatory flexibility analysis under 5 U.S.C. 603 or 604. See 5 U.S.C. 601(2), 604(a). Nor is the Commission required to submit these revisions for congressional review under FECA or the Funding Acts. See 52 U.S.C. 30111(d)(1), (4) (providing for congressional review when Commission “prescribe[s]” a “rule of law”); 26 U.S.C. 9009(c)(1), (4), 9039(c)(1), (4) (same). Accordingly, these corrections are effective upon publication in the Federal Register.

The Commission is updating paragraph (a) of this section regarding when a person may appeal the Commission's failure to respond to a document inspection or production request filed under the Freedom of Information Act (“FOIA”), 5 U.S.C. 552. Paragraph (a) currently provides that a person may appeal the Commission's failure to respond if the person has received no response within ten working days after the Commission received the FOIA request. When originally promulgated, this ten-day time period accurately reflected the time the Commission had to respond to a FOIA request. See 5 U.S.C. 552(a)(6)(A)(i) (1979); Public Records and Freedom of Information Act, 44 FR 33368 (June 8, 1979) (promulgating section 4.7(c), giving Commission ten working days to respond to FOIA request, and section 4.8(a), allowing FOIA requestors who did not receive response within ten working days to file appeals). Subsequently, however, Congress amended FOIA to allow agencies 20 days in which to respond to FOIA requests, and the Commission revised its own response period in 11 CFR 4.7(c) accordingly. See Electronic Freedom of Information Act Amendments, 65 FR 9201 (Feb. 24, 2000). The Commission did not, however, make the necessary corresponding change to the regulation governing the time for filing an appeal. Accordingly, to conform the time period for appealing the Commission's failure to respond with the time that the Commission has to respond, the Commission is revising paragraph (a) by removing the word “ten” and replacing it with “twenty.”

The Commission is correcting two erroneous citations in the introductory paragraph of this section. This paragraph erroneously refers to 11 CFR 100.74 and 100.75 in discussing the exemption of certain legal and accounting services from the definition of “contribution.” That exemption is set forth in sections 100.85 and 100.86, not in sections 100.74 and 100.75 (which address volunteer services and the use of a volunteer's real or personal property). Accordingly, the Commission is removing the citations to 11 CFR 100.74 and 100.75 and replacing them with 11 CFR 100.85 and 100.86, respectively.

The Commission is amending paragraphs (b)(1) and (2) of this section to remove an ambiguity regarding the reporting requirements for political committees making independent expenditures in a calendar year. These paragraphs require political committees to report all independent expenditures aggregating less than $10,000 (paragraph (b)(1)) or $10,000 or more (paragraph (b)(2)) with respect to a given election made “at any time during the calendar year up to and including the 20th day before an election.” Some reporting entities have expressed uncertainty as to whether this language signifies that reporting is not required in a calendar year other than an election year. As the Commission noted in promulgating this section, the reporting requirement applies to independent expenditures made by a political committee “at any time” and “at any point in the campaign,” up to and including 20 days before an election. 52 U.S.C. 30104(g)(2); Bipartisan Campaign Reform Act of 2002 Reporting, 68 FR 404, 406 (Jan. 3, 2003). To clarify that a political committee must report independent expenditures aggregating less than $10,000, or $10,000 or more, with respect to a given election made in any calendar year, the Commission is amending portions of the text in paragraphs (b)(1) and (2).

The Commission is revising paragraphs (b) and (g) of this section to reflect the availability and use of internet-based forms to file reports electronically with the Commission. The Commission has made a number of these forms available for use by filers on its Web site, at www.fec.gov. Paragraph (b) provides that a political committee or other person not required to file reports electronically with the Commission may nonetheless choose to file reports in an electronic format that meets the requirements of this section, and a person who chooses to file reports electronically is generally required to continue to file electronically for the rest of that calendar year. The Commission is adding a reference to internet-based forms to paragraph (b), as an example of an electronic format that meets the requirements of this section.

Paragraph (g) requires the treasurer of a political committee and other persons responsible for filing reports with the Commission to verify the reports in specific ways. The Commission is revising paragraph (g) to clarify that a signed certification on a Commission internet form meets the verification requirement.

The Commission is also correcting a typographical error in paragraph (a)(3)(i)(A) of this section by replacing the phrase “nets debts” with the phrase “net debts.”

The Commission is correcting an erroneous citation in paragraph (d)(1) of this section. Paragraph (d)(1) requires a political committee that collects both federal and nonfederal funds through a joint activity to allocate its direct costs of fundraising “as described in paragraph (a)(2) of this section” in a certain manner. Paragraph (a)(2) of this section, however, does not exist. Instead, the direct costs of fundraising are described in paragraph (b)(1) of this section. Thus, the Commission is replacing the reference to paragraph (a)(2) in paragraph (d)(1) with a reference to paragraph (b)(1).

The Commission is correcting an erroneous citation in paragraph (d)(1)(ii) of this section. Paragraph (d)(1)(ii) requires state, district, and local party committees to use only federal funds to pay the salaries, wages, and fringe benefits of employees who spend more than 25% of their compensated time on federal election activities or activities in connection with a federal election, and cites to 11 CFR 300.33(d)(1). Paragraph (d)(1) of § 300.33, however, concerns employees who spend 25% or less of their compensated time on federal election activities or activities in connection with a federal election. Paragraph (d)(2) of § 300.33, on the other hand, relates to the payment of employees spending more than 25% of their compensated time on such activities. Accordingly, the Commission is replacing the reference to 11 CFR 300.33(d)(1) in paragraph (d)(1)(ii) with 11 CFR 300.33(d)(2).

The Commission is amending paragraph (c) of this section to remove an ambiguity regarding the reporting requirements for persons who are not political committees and make $10,000 or more in independent expenditures in a calendar year. For the reasons explained above regarding the amendments to section 104.4, the Commission is amending portions of the text in paragraph (c).

The Commission is correcting a typographical error in paragraph (b)(6) of this section. This Commission is replacing the reference to 11 CFR 110.1(1)(4) with a reference to 11 CFR 110.1(l)(4) (lowercase letter L).

The Commission is correcting a typographical error in paragraph (b)(6) of this section. The Commission is replacing the reference to 11 CFR 110.1(1)(4) with a reference to 11 CFR 110.1(l)(4) (lowercase letter L).

The Commission is correcting an erroneous citation in paragraph (g)(1)(i)(I) of this section. The last sentence of paragraph (g)(1)(i)(I) prohibits “[a] Federal officeholder, as defined in 11 CFR 100.5(f)(1),” from receiving salary payments from campaign funds as a candidate. Paragraph (f)(1) of § 100.5, however, defines “authorized committee,” not “Federal officeholder.” Paragraph (c) of § 113.1, on the other hand, defines “Federal officeholder.” As such, in the last sentence of paragraph (g)(1)(i)(I), the Commission is replacing “11 CFR 100.5(f)(1)” with “paragraph (c) of this section.”

The Commission is making a conforming change to the note to paragraph (b) of this section. In the note, the word “non-connected” appears twice. The Commission is replacing both references to “non-connected” with “nonconnected” to conform the word to how it appears in the rest of 11 CFR chapter 1.

For the reasons noted above regarding the correction to § 114.2, the Commission is replacing both references to “non-connected” in the note to § 114.10(a) with “nonconnected.”

The Commission is correcting a typographical error in paragraph (c) of this section. The Commission is removing the misspelled word “Deducation” and replacing it with the word “Deduction.”

The Commission is correcting an erroneous citation in paragraph (c)(1)(iii) of this section. This paragraph addresses the reattribution of contributions among joint tenants of a checking account, and requires the documentation “described in 11 CFR 110.1(1), (3), (5), and (6)” to accompany the reattributed contribution. The citation to 11 CFR 110.1(1), (3), (5), and (6) is incorrect, however, because those paragraphs do not exist. Instead, the documentation requirements for reattributed contributions appear in paragraph (l) (lowercase letter L) of section 110.1. Accordingly, the Commission is replacing the reference to 11 CFR 110.1(1), (3), (5), and (6) in § 9034.2 with 11 CFR 110.1(l)(3), (5), and (6).

For the reasons set out in the preamble, the Federal Election Commission amends 11 CFR chapter I, as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2005-18-18, Amendment 39-14258 (70 FR 53554, September 9, 2005) (“AD 2005-18-18”). AD 2005-18-18 applied to certain The Boeing Company Model 757-200, -200PF, -200CB, and -300 series airplanes. The NPRM published in the Federal Register on March 27, 2015 (80 FR 16318) (“the NPRM”). The NPRM was prompted by a report that the service information referenced in AD 2005-18-18 did not adequately address FSV wires at the aft end of the strut, for both left and right engine struts. The NPRM proposed to continue to require inspections of certain wire bundles in the left and right engine-to-wing aft fairings for discrepancies; installation of back-to-back p-clamps between the wire and hydraulic supply tube at the aft end of the right-hand strut only; and associated re-routing of the wire bundles, if necessary. The NPRM also proposed to require installation of tetrafluoroethylene spiral cable wrap on the FSV wires at the aft end of the strut that would provide additional wiring protection. We are issuing this AD to prevent chafing between the wire bundle and the structure of the aft fairing, which could result in electrical arcing and subsequent ignition of flammable vapors and a possible uncontrollable fire.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Boeing requested clarification of the actions required by paragraph (g) of the proposed AD. Boeing suggested that paragraph (g) of the proposed AD be revised to add a statement to clarify that no further work would be required if the requirements of AD 2005-18-18 have already been accomplished.

We agree to provide clarification. In paragraph (g) of this AD, we restated the requirements of paragraph (f) of AD 2005-18-18. Paragraph (f) of this AD states, “Comply with this AD within the compliance times specified, unless already done.” If operators have already done the actions required by paragraph (f) of AD 2005-18-18, they have already done the actions required by paragraph (g) of this AD. If operators have not already done the actions required by paragraph (g) of this AD before the effective date of the AD, then they must use the most recent revision of the service information. We have not changed this AD in this regard.

Boeing requested clarification of the compliance times stated in paragraph (h) of the proposed AD. Boeing stated that there is confusion between “Within 60 months after the effective date of this AD . . . ,” as stated in the first sentence of the paragraph for the spiral cable wrap installation, and “. . . before further flight,” as stated in the second sentence for the related investigative and corrective actions. Boeing suggested that the second sentence be deleted from paragraph (h) of the proposed AD.

We do not agree to revise paragraph (h) of this AD. The installation of the spiral cable wrap includes related investigative and corrective actions, i.e., doing inspections for damaged wire bundles, repairing damaged wires, and testing certain fuel shutoff wires. These related investigative and corrective actions must be done before further flight after damage is found. We have not changed the AD in this regard.

FedEx requested that the proposed AD be revised to add a paragraph granting credit for accomplishing Boeing Service Bulletin 757-28A0073 or 757-28A0074, both Revision 2, both dated June 4, 2009, before the effective date of the AD. FedEx stated that they had already accomplished the requirements on airplanes in their fleet.

We agree to clarify. The intent of paragraph (f) of this AD is to provide relief for accomplishing the requirements of this AD before the effective date of this AD. Therefore, this AD already includes the credit requested by the commenter. We have not changed this AD in this regard.

United Airlines (UAL) requested that a paragraph be added to the proposed AD to allow credit for all previously approved AMOC letters that affect Boeing Service Bulletin 757-28A0073 or 757-28A0074.

We do not agree to add a new paragraph to this AD. Credit is already provided in paragraph (i)(4) of this AD, which specifies that AMOCs approved for AD 2005-18-18 are also acceptable as AMOCs for the corresponding provisions of paragraph (g) of this AD. (Paragraph (g) of this AD restates the requirements of paragraph (f) of AD 2005-18-18.) Paragraph (h) of this AD is a new requirement and AMOCs cannot be approved for that paragraph until this AD is published. We have not changed this AD in this regard.

UAL requested relief for Model 757-300 airplanes that is similar to that provided to the Model 757-200 airplanes in FAA AMOC letter 757-28A0073-AMOC-01.

We agree. The issue that the AMOC letter addresses (for Boeing Service Bulletin 757-28A0073, Revision 2, dated June 4, 2009) also exists in Boeing Service Bulletin 757-28A0074, Revision 2, dated June 4, 2009. We have revised paragraphs (g) and (h) of this AD to include a statement that where Boeing Service Bulletin 757-28A0074, Revision 2, dated June 4, 2009, states “SWPM 20-10-11, Table IX,” this AD instead requires “SWPM 20-10-11, `Minimum Clearance' Table.”

UAL requested that the proposed AD be revised to require incorporation of a required repetitive inspection of the modification into the MPD requirements for Model 757 Heavy Check intervals, preferably at intervals of 3,000 flight cycles or 20 months. UAL suggested that this addition to the MPD could ensure the long-term integrity of the modification.

We do not agree to require a revision to the MPD. We infer that the term “modification” used by UAL is intended to refer to the corrective actions required by paragraph (g) of this AD, and the cable wrap installation and related investigative and corrective actions required by paragraph (h) of this AD. These actions required by paragraphs (g) and (h) of this AD are considered to provide long-term integrity of the “modification” and maintain an acceptable level of safety. However, we encourage operators to proactively revise their maintenance programs in accordance with FAA regulations to address problems or issues as they arise. We have not changed this AD in this regard.

Aviation Partners Boeing (APB) stated that the installation of winglets per Supplemental Type Certificate (STC) ST01518SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/312bc296830a925c86257c85006d1b1f/$FILE/ST01518SE.pdf) does not affect accomplishment of the manufacturer's service instructions.

We agree with the commenter that STC ST01518SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/312bc296830a925c86257c85006d1b1f/$FILE/ST01518SE.pdf) does not affect the accomplishment of the manufacturer's service instructions. Therefore, the installation of STC ST01518SE does not affect the ability to accomplish the actions required by this AD. We have not changed this AD in this regard.

We have revised the format of paragraph (g) of this AD by converting Table 1 to paragraph (g)(1) to text in paragraph (g). This change to the format does not affect the requirements of paragraphs (g), (g)(1), or (g)(2) of this AD.

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

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

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

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

We reviewed Boeing Alert Service Bulletins 757-28A0073 and 757-28A0074, both Revision 2, both dated June 4, 2009. The service information describes procedures for inspecting certain wire bundles in the left and right engine-to-wing aft fairings for discrepancies; installing back-to-back p-clamps between the wire and hydraulic supply tube at the aft end of the right-hand strut only; associated re-routing of the wire bundles, if necessary; and installing spiral cable wrap on FSV wires on the aft ends of the left and right engine struts, and related investigative and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 346 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 777 airplanes. The NPRM published in the Federal Register on May 14, 2015 (80 FR 27601) (“the NPRM”). The NPRM was prompted by reports of unreliable performance of the fuel scavenge system. The NPRM proposed to require changing the main fuel tank water scavenge system, center fuel tank fuel scavenge system, and certain electrical panels; related investigative actions; and doing corrective actions if necessary; and, for certain airplanes, changing the fuel scavenge system to give redundant control of the center override/jettison fuel pumps and main jettison fuel pumps. We are issuing this AD to prevent fuel exhaustion and subsequent power loss of all engines due to loss of capability to scavenge fuel in the center fuel tank.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Lufthansa Cargo AG stated that the unsafe condition addressed in the NPRM is not a safety concern and that mandating Boeing Special Attention Service Bulletin 777-28-0078, dated September 4, 2014, is not justified. Lufthansa Cargo AG stated that the main fuel tanks must be fully loaded with fuel when a mission flight requires fuel in the center tank. Lufthansa Cargo AG explained that if the fuel scavenge system fails to scavenge the remaining fuel in the center tank, the fuel in the main tanks is still available, and therefore there is no safety concern.

We infer that the commenter requests we withdraw the NPRM. We do not agree with the commenter's request. The failure of fuel scavenging means that up to 2,700 pounds of fuel that is required by mission planning would not be available if needed. The actions required by this AD are necessary in order to prevent fuel exhaustion and subsequent power loss of all engines due to loss of capability to scavenge fuel in the center fuel tank. We have not changed this AD in this regard.

Boeing, Aerologic GmbH, and British Airways (BAC) requested that we remove the modification required by paragraph (g) of the proposed AD, but instead mandate installation of airplane information management system (AIMS) 2 software V14 or later to address the unsafe condition. Aerologic GmbH and BAC stated that the unsafe condition can be mitigated by incorporation of AIMS 2 software Vl4 or later, which provides an engine indicating and crew alerting system (EICAS) advisory message to alert the flightcrew of the status of the scavenge system and the possibility of unusable trapped fuel. Boeing stated that the trapped fuel quantity is well below reserve fuel requirements and that the flightcrew can take appropriate actions to avoid a fuel exhaustion condition.

We do not agree with the commenters' request. We worked with Boeing extensively on this issue in order to define a reliable automated solution, appropriate to address the severity of this safety issue. While Boeing may disagree, we have determined that relying solely on AIMS 2 software V14 or later is not sufficient to address the identified unsafe condition under all flight conditions. The approach in Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015, yields a higher confidence of fully mitigating the safety issue since a robust automated software solution (i.e., installing electrical load management system 2 (ELMS 2) software) removes the potential for human error to undermine the safety mitigation. We have not changed this AD in this regard.

Boeing requested that we delay issuance of the final rule until the modified scavenge system is certified on Model 777 airplanes equipped with an auxiliary fuel tank. Boeing stated that this will allow this final rule to require the accomplishment of Boeing Service Bulletin 777-28-0078 on all applicable airplanes and avoid the need for multiple ADs on the same subject.

We infer the commenter is requesting that we delay issuance of the final rule until a revision of Boeing Service Bulletin 777-28-0078 is available for reference in the final rule. We do not agree with the commenter's request. We do not have a definitive date when the modified scavenge system will be certified on Model 777 airplanes equipped with an auxiliary fuel tank and the related service bulletin revision will be available. To delay this action would be inappropriate, since we have determined that an unsafe condition exists. We have also determined that it is not warranted to delay this final rule in order to avoid issuance of multiple ADs on the same subject. We have not changed this AD in this regard.

Boeing, All Nippon Airways (ANA), Delta Airlines (DAL), Emirates Airline, FedEx Express, and United Airlines (UAL) requested that we revise the NPRM to incorporate Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015. Boeing requested that we provide credit for prior actions done using Boeing Special Attention Service Bulletin 777-28-0078, dated September 4, 2014.

We agree with the commenters' requests. Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015, provides revised instructions and top-kits to accomplish the modification. No new work is required by this revision. We have revised paragraphs (c), (g), (h)(1), (h)(2), and (i) of this AD to refer to Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015. We have added new paragraph (j)(2) of this AD to provide credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this final rule using Boeing Special Attention Service Bulletin 777-28-0078, dated September 4, 2014. We have redesignated paragraph (j) of the proposed AD as paragraph (j)(1) in this AD.

Boeing requested that we remove the wording “prior to” in paragraph (h)(2) of the proposed AD, which would require actions to be done concurrently with the actions specified in paragraph (g) of the proposed AD.

We agree with the commenter's request. Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015, specifies concurrent, not prior, accomplishment of the service information specified in paragraph (h) of this AD. We have revised paragraph (h) of this AD accordingly, which does not expand the requirements of this AD.

ANA, DAL, Emirates Airline, FedEx, and UAL requested that we include in the NPRM the information specified in Boeing IN 777-28-0078 IN 02. FedEx also requested that we include in the NPRM the information specified in Boeing IN 777-28-0078 IN 03. ANA and Emirates Airline requested that a new Boeing Service Bulletin (Revision 2 of Boeing Service Bulletin 777-28-0078) be mandated if possible.

The commenters stated that Boeing IN 777-28-0078 IN 02 clarifies the instructions in Boeing Special Attention Service Bulletin 777-28-0078, and also indicates that Boeing Special Attention Service Bulletin 777-28-0078 will be revised to incorporate those clarifications.

ANA requested that a cable assembly with a different lock wire length (part number BACC13AT3K()) be allowed for use in place of part number BACCI3AT3Kl2 for the actions specified in paragraph (g) of the proposed AD. ANA also identified an error in Boeing Special Attention Service Bulletin 777-28-0078, dated September 4, 2014, regarding the position of the connector D11007P.

We do not agree with the commenters' requests. We have determined that Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015, is adequate to correct the identified unsafe condition, and the errors will not affect compliance with this AD. The information notices (IN) are issued to provide clarity and are not required to accomplish the required actions. We are working with Boeing to include the IN information and part number substitution and other corrections in Revision 2 of Boeing Service Bulletin 777-28-0078. Under the provisions of paragraph (k) of this AD, once Revision 2 of Boeing Service Bulletin 777-28-0078 is issued, we will consider requests to approve it as an alternative method of compliance (AMOC) with this AD. In addition, AMOCs for part number substitutions can also be requested through the provisions of paragraph (k) of this AD. We have not changed this AD in this regard.

An anonymous commenter stated that Model 777 airplanes have an integer overflow error when being operated over a certain number of days. The commenter stated that we should require the computer to be reset before any of the overflow errors happen during flight.

We do not agree with the commenter's request. This issue does not appear related to the identified unsafe condition that is the subject of this final rule. However, we will investigate this situation to make sure that the issue stated by the commenter does not exist or is addressed in a proper manner. We have not changed this final rule in this regard.

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

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

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

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

Boeing has issued the following service information.

• Boeing Service Bulletin 777-28A0047, Revision 5, dated September 20, 2010. This service information describes procedures for installing new P301 and P302 panels, changing the wiring, and performing bonding resistance measurements.

• Boeing Service Bulletin 777-28A0047, Revision 6, dated July 11, 2013. This service information describes procedures for installing new P301 and P302 panels, changing the wiring, and performing bonding resistance measurements.

• Boeing Special Attention Service Bulletin 777-28-0078, Revision 1, dated April 27, 2015. This service information describes procedures for doing mechanical changes to the main fuel tank water scavenge system and center fuel tank fuel scavenge system; doing wiring changes between the P105, P110 and P301 panels, and between the P200, P205, P210 and P302 panels; doing wiring changes in the P105 panel; installing new electrical load management system 2 (ELMS2) software; and doing functional testing.

GE Aviation has issued the following service information.

• GE Aviation Service Bulletin 5000ELM-28-075, Revision 1, dated August 5, 2014. This service information describes procedures for doing wiring changes in the P110 panel.

• GE Aviation Service Bulletin 6000ELM-28-076, Revision 1, dated August 5, 2014. This service information describes procedures for doing wiring changes in the P210 panel.

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

We estimate that this AD affects 55 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2011-23-05, Amendment 39-16856 (76 FR 67343, November 1, 2011) (“AD 2011-23-05”). AD 2011-23-05 applied to certain Model 737-300, -400, and -500 series airplanes. The NPRM published in the Federal Register on November 27, 2015 (80 FR 74047) (“the NPRM”). The NPRM was prompted by an evaluation by the DAH that indicates the fuselage frames and frame reinforcements are subject to WFD. The NPRM proposed to continue to require repetitive inspections for cracking of the 1.04-inch nominal diameter wire penetration hole, and applicable related investigative and corrective actions. The NPRM also proposed to add new inspection areas, a modification that terminates certain inspections, post-modification inspections, and repair if necessary. We are issuing this AD to detect and correct fatigue cracking of the fuselage frames and frame reinforcements that could result in reduced structural integrity of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Aviation Partners Boeing stated that accomplishing the supplemental type certificate (STC) ST01219SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/ebd1cec7b301293e86257cb30045557a/$FILE/ST01219SE.pdf) does not affect the actions specified in the NPRM.

We agree with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) and added a new paragraph (c)(2) to this AD to state that installation of STC ST01219SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/ebd1cec7b301293e86257cb30045557a/$FILE/ST01219SE.pdf) does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

Boeing requested that we change the applicability to “all” airplanes instead of airplanes referenced in Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015. Boeing stated that Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015, specifies the effectivity as “all” airplanes.

We agree with the commenter's request. In the NPRM we referred to Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015, which specifies an effectivity of all Model 737-300, -400, and -500 series airplanes. For clarity, we have revised the SUMMARY section and paragraph (c)(1) of this AD to specify “all” airplanes.

Southwest Airlines (SWA) requested that we revise paragraph (t) of the proposed AD to clearly state all inspections required by paragraph (n) of the proposed AD will be due at the later of 30,000 total flight cycles or 4,500 flight cycles from the effective date of the AD. SWA stated that, for airplanes which have previously accomplished the inspections specified in Boeing Alert Service Bulletin 737-53A1279, Revision 1, dated September 2, 2011, paragraph (n) of the proposed AD and table 1 of paragraph 1.E., “Compliance,” in Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015, currently requires inspections 4,500 flight cycles from the last inspection and do not specifically take into account those airplanes already doing the repetitive inspections.

We do not agree with the commenter's request. AD 2011-23-05 required inspections on airplanes with less than 40,000 total flight cycles to begin prior to 30,000 total flight cycles or within 90 days from November 16, 2011 (the effective date of AD 2011-23-05), whichever occurs later. The repetitive inspection intervals of 4,500 flight cycles are not changed. The new WFD requirement lowers the initial airplane applicability total flight cycles from 40,000 to 30,000. Paragraph (n) of this AD addresses airplanes with more than 30,000 total flight cycles as of the effective date of the AD, and all airplanes that have already accomplished the initial inspection or a repetitive inspection. These airplanes are to continue the repetitive inspections at intervals not to exceed 4,500 flight cycles from the last inspection. The commenter's requested change would reset the time to the next inspection from the effective date of this AD instead of from the last inspection. This would result in a one-time increase in the repetitive interval, which would not meet the WFD requirements. We have not changed this AD in this regard.

Boeing requested that we clarify the inspections required in paragraph (m) and (n) of the proposed AD. Boeing stated that the words “an inspection” is not specific enough to ensure the required inspections will be accomplished.

We agree with the commenter's request. The wording “an inspection” could be interpreted incorrectly, and the Part 2 or Part 4 inspections specified in Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015, may not be accomplished prior to installation of the preventive modification.

We have revised paragraph (m) of this AD to state in part, “before further flight after accomplishing the Part 2 or Part 4 inspections specified in this paragraph, and no cracking was found, do “Part 5—Preventative Modification” as specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015.”

We have revised paragraph (n) of this AD to state in part, “before further flight after accomplishing the Part 4 inspection specified in this paragraph, and no cracking was found, do “Part 5—Preventative Modification” as specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015.”

Boeing requested that we remove the LFEC inspection in paragraph (s) of the proposed AD. Boeing stated that paragraph (s) of the proposed AD is applicable to Groups 4 through 6 as identified in Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015, and that LFEC inspections are not required for Groups 4 through 6.

We agree with the commenter's request. We have revised paragraph (s) of this AD by removing the LFEC inspection requirement.

Boeing requested that we include “0.50 inch diameter holes” in the first bullet under the Related Service Information Under 1 CFR part 51 section. Boeing stated that the 0.50 inch hole was one of the main updates of Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015.

We agree with commenter's request and have revised this final rule accordingly.

Boeing requested that we revise paragraph (u)(3) of the proposed AD to reference the Los Angeles ACO instead of the Seattle ACO.

We agree with the commenter's request. In July 2014, the Los Angeles ACO assumed responsibility for the out-of-production Model 737 airplanes. We have revised paragraph (u)(3) of this AD and the engineer contact information accordingly.

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

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

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

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

We reviewed Boeing Alert Service Bulletin 737-53A1279, Revision 2, dated April 21, 2015. The service information describes procedures for the following actions.

• Inspections of wire penetration holes, 0.50 inch diameter holes, standoff/tooling holes, and the production fastener holes for cracking in the forward cargo compartment frames and frame reinforcements, between stringer (S) S-19 and S-22, on both left and right sides of the airplane.

• A preventive modification of frames between S-19 and S-22.

• Post-modification inspections.

• Repairs.

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

We estimate that this AD affects 605 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001) (“AD 2001-12-18”). AD 2001-12-18 applied to certain CASA Model CN-235 series airplanes. The NPRM published in the Federal Register on January 19, 2016 (81 FR 2783) (“the NPRM”).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0262, dated December 5, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Defense and Space S.A. Model CN-235-100 and -200 airplanes. The MCAI states:

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

We have clarified the Applicability in paragraph (c) of this AD. For Model CN-235 airplanes, the affected serial numbers (S/N) are C-001 through C-015 inclusive. We have removed S/N C-074 for Model CN-235 airplanes because there are no Model CN-235 airplanes with that serial number.

For Model CN-235-100 and -200 airplanes, the affected serial numbers are C-016 through C-073 inclusive. We have removed S/Ns C-001 through C-015 inclusive and C-074 for CN-235-100 and -200 airplanes because there are no Model CN-235-100 and -200 with those serial numbers.

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

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

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

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

Airbus Defense and Space S.A. has issued Airbus Military Alert Operators Transmission AOT-CN235-76-0001, dated May 27, 2014. This service information describes repetitive replacements of each power lever and condition lever Teleflex cable having a certain part number with a new or serviceable part. This service information also provides a new life limit of 5,000 flight cycles. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 3 airplanes of U.S. registry.

The rigging required by AD 2001-12-18, and retained in this AD takes about 8 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the rigging that was required by AD 2001-12-18 is $680 per product.

The replacement required by AD 2001-12-18, and retained in this AD takes about 47 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $1,444 per product. Based on these figures, the estimated cost of the replacement that was required by AD 2001-12-18 is $5,439 per product.

We also estimate that it would take about 47 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $6,480 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $31,425, or $10,475 per product.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Taos Regional Airport, Taos, NM.

On March 7, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class E airspace extending upward from 700 feet above the surface at Taos Regional Airport, Taos, NM (81 FR 11695). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received from Mr. Robert Pigott, Aeronautical Information Services, requesting clarification of the overlapping 1,200 foot airspace to the west of Taos Regional Airport. This airspace existed prior to the proposed amendment and was not changed by the amendment. The 1,200 foot airspace exists to protect the departures and climb out requirements to the west due to high terrain east of the airport and allows departing aircraft to reach controlled airspace, and was developed in accordance with FAA Joint Order 7400.2K, Procedures for Handling Airspace Matters. The FAA found no reason to change the 1,200 foot airspace at this time.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at Taos Regional Airport, Taos, NM. After review, the FAA found that with the decommissioning of NDBs, removal of NDB approaches, and implementation of area navigation (RNAV) instrument approaches the extension to the northwest from the 6.5-mile radius to 9.4 miles of the Class E airspace extending upward from 700 feet above the surface was no longer requires in accordance with airspace requirements specified in FAA Joint Order 7400.2K.

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

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Belle Fourche Municipal Airport, Belle Fourche, SD; Madison Municipal Airport, Madison, SD; Mobridge Municipal Airport, Mobridge, SD; and Harold Davidson Field, Vermillion, SD.

On February 17, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class E airspace extending upward from 700 feet above the surface at Belle Fourche Municipal Airport, Belle Fourche, SD; Madison Municipal Airport, Madison, SD; Mobridge Municipal Airport, Mobridge, SD; and Harold Davidson Field, Vermillion, SD (81 FR 8029). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at Belle Fourche Municipal Airport, Belle Fourche, SD; Madison Municipal Airport, Madison, SD; Mobridge Municipal Airport, Mobridge, SD; and Harold Davidson Field, Vermillion, SD. Airspace reconfiguration is necessary due to the decommissioning of NDBs and/or the cancellation of the NDB approach at each airport. As a result of advances in GPS capabilities, controlled airspace is redesigned for the safety and management of the standard instrument approach procedures for IFR operations at the airports.

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

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

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

Background

This final rule is promulgated under Section 203 of the Bipartisan Budget Act of 2013, Public Law 113-67 (Act), passed into law on December 26, 2013. The Act prohibits the Secretary of Commerce (Secretary) from disclosing DMF information during the three-calendar-year period following an individual's death (referred to as the “Limited Access DMF,” or “LADMF”), unless the person requesting the information has been certified to access that information pursuant to certain criteria in a program that the Secretary establishes. The Act further requires the Secretary to establish a fee-based program to certify Persons for access to LADMF. In addition, it provides for penalties for Persons who receive or distribute LADMF without being certified or otherwise satisfying the requirements of the Act. The Secretary has delegated the authority to carry out Section 203 to the Director of NTIS.

The Act mandated that no person could receive LADMF without certification after March 26, 2014 (i.e., 90 days from enactment of the Act). NTIS acted promptly to ensure that a suitable certification program was in place by that date, and to avoid interruption of access by legitimate users of the data. On March 3, 2014, NTIS published a Request for Information (RFI) and Advance Notice of Public Meeting on the Certification Program for Access to the Death Master File (79 FR 11735). NTIS held the public meeting, with webcast, on March 4, 2014. Written comments received in response to the RFI, and a transcription of oral comments submitted at the public meeting, may be viewed at https://dmf.nist.gov.

On March 26, 2014, NTIS published an interim final rule, “Temporary Certification Program for Access to the Death Master File” (interim final rule) (79 FR 16668). That rule codified an interim approach to implementing the Act's provisions pertaining to the certification program and the penalties for violating the Act, and set out an interim fee schedule for the program. NTIS published the interim final rule in order to provide a mechanism for Persons to access LADMF immediately on the effective date prescribed in the Act. Written comments received in response to the Interim Final Rule may be viewed at http://www.regulations.gov.

The preambles for both the RFI and the interim final rule set out the specific provisions of the Act, and also noted that several Members of Congress described their understanding of the purpose and meaning of Section 203 during Congressional debate on the Joint Resolution which became the Act. Citations to those Member statements were provided in the RFI, which also provided background on the component of the DMF, which originates from the Social Security Administration, covered by Section 203. The interim final rule was established to provide immediate access to the LADMF to those users who demonstrated a legitimate fraud prevention interest, or a legitimate business purpose for the information, and to otherwise delay the release of the LADMF to all other users, thereby reducing opportunities for identity theft and restricting information sources used to file fraudulent tax returns.

In addition, in December, 2014, NTIS issued an initial public draft of “Limited Access Death Master File (Limited Access DMF) Certification Program Publication 100,” (Publication 100), available at https://dmf.ntis.gov. Publication 100 is the NTIS security guideline document for persons certified under this final rule. Publication 100 sets forth suggested security controls, standards and protocols for the protection of LADMF in the possession of Certified Persons.

On December 30, 2014, NTIS published the proposed rule (79 FR 78314). The proposed rule introduced changes, clarifications and additions to the interim final rule, based in part upon comments received. For example, the proposed rule introduced a “safe harbor” provision, § 1110.103, which would exempt a Certified Person from penalty for disclosure of LADMF to another Certified Person. The proposed rule set forth a provision for review, assessment, audit and attestation of a Person's information and information security controls by independent, third party conformity assessment bodies. Section 1110.201 of the proposed rule would permit Certified Persons to provide the attestation of an “Accredited Certification Body” (as defined in § 1110.2) concerning the adequacy of the Certified Person's “systems, facilities and procedures in place to safeguard DMF information.”

NTIS requested that all written comments on the proposed rule be submitted to Regulations.gov by January 31, 2015. The agency, however, received requests to extend the public comment period. In response, on January 28, 2015, NTIS published a notice extending the comment period until March 30, 2015 (80 FR 4519). Written comments received in response to the proposed rule may be viewed at http://www.regulations.gov.

In response to the proposed rule, NTIS received 62 written comments. The commenters included one foreign government, twenty industry and trade associations, five service providers, three financial services companies, two insurance companies, four health care and medical research organizations and five service providers. The remainder of the commenters were primarily individuals, including a number identifying themselves as genealogists.

In preparing this final rule, NTIS has carefully considered all comments received in response to the proposed rule. Many commenters requested that NTIS provide unrestricted access to LADMF. However, NTIS cannot revise the rule to accommodate such comments, since access to and use of LADMF is governed by the statutory provisions set forth in Section 203 of the Act. A number of commenters requested changes to the composition of the DMF itself; however, the composition of the DMF is explicitly defined in Section 203(d) of the Act as consisting of “the name, social security account number, date of birth and date of death of deceased individuals maintained by the Commissioner of Social Security.” NTIS, therefore, has no discretion to alter the composition of the DMF. Some commenters suggested that NTIS should enhance search capabilities available to DMF subscribers. NTIS has no present plans to alter database search capabilities, but may consider doing so in the future. However, NTIS's database search capabilities are not an element of this final rule. NTIS also received multiple comments to the effect that the proposed subscription cost of the LADMF should be reduced; however, Section 203(b)(3) mandates the charge of fees sufficient to cover costs associated with the certification program. The certification fee that NTIS charges covers the costs of receiving and processing applications, including authenticating the statements made in the application, and ensuring access to the Limited Access DMF.

A number of comments were received asserting that some Certified Persons need to provide LADMF date of death information in the ordinary course of their business, for example, to retirement plans and others who have a legal obligation to provide death benefits payments to beneficiaries or for other legitimate purposes, and some suggested that the rule should specifically provide for the disclosure of date of death information alone as an exception to requirement for certification. However, as noted above, “date of death” is one of the four elements (the others being name, social security number, and date of birth) expressly set forth in the statutory definition of the term “Death Master File” under the Act, and NTIS is without discretion to categorically exclude it through rulemaking. NTIS notes that it received no comments suggesting that retirement plans and others having a legal obligation to provide death benefits would be unable to demonstrate one or more of a legitimate fraud prevention interest, business purpose, or fiduciary duty, to qualify for certification or, if not certified, that they would be unable to demonstrate, first, that they meet the requirements for LADMF access (i.e., the legitimate fraud prevention or business purpose and security requirements of § 1110.102(a)(1), (2), and (3)), and, second, that they would not misuse or further disclose LADMF to a person who would either wrongfully use LADMF or could not comply with the security requirements set forth in § 1110.200(a)(1)(ii) or (iii) respectively. NTIS points out that “fact of death,” i.e., the fact that a person is no longer living, confirmation of which was identified by some commenters as important for legitimate business purposes, is not an element of the statutory definition of the term “Death Master File,” and will not be considered by NTIS to be equivalent to “date of death” under the final rule.

NTIS also notes that the proposed rule would revise the definition of “Limited Access DMF” to provide that an individual element of information (name, social security number, date of birth, or date of death) in the possession of a Person, whether or not certified, but obtained by such Person through a source independent of the Limited Access DMF, would not be considered “DMF information.” That revision is retained in the final rule, and has been further clarified in response to comments. Specifically, NTIS has replaced the term “Certified Person” in the last sentence of the LADMF definition with “Person” to make clear that any Person, whether or not certified, who obtains an individual element of information independently is not considered to possess “Limited Access DMF.”

Comments were received suggesting that, for clarity and simplicity, the final rule should refer to the defined term “Limited Access DMF” to the extent possible. NTIS has incorporated these comments into the final rule, including §§ 1110.102(a)(4) and 1110.200(a)(1).

NTIS received comments supporting the provision of the proposed rule that would amend § 1110.102(a)(2) and (3) to clarify that, to be certified to obtain access to the Limited Access DMF, a Person must certify both that the Person has systems, facilities, and procedures in place to safeguard the accessed information, and experience in maintaining the confidentiality, security, and appropriate use of accessed information, pursuant to requirements similar to the requirements of section 6103(p)(4) of the Internal Revenue Code of 1986, and that the Person “agrees to satisfy such similar requirements.”

This standard differs from the requirement of Section 203 of the Act, because that Section contains contradictory statements about the types of systems to safeguard information that a Certified Person must have in place. In Section 203(b)(2)(B), the Act states that in order to receive Limited Access DMF, a Person must agree to comply with requirements “similar to” Section 6103(p)(4) of the Internal Revenue Code (IRC). Section 6103(p)(4) of the IRC is directed to Federal government agencies, and as such the “similar to” statement makes sense for non-government actors which are the subject of the Act. However, Section 203(b)(2)(C) requires a Certified Person to also “satisfy the requirements of such section 6103(p)(4) as if such section applied to such person.” It is unclear how or why a Certified Person could or should satisfy safeguarding requirements “similar to” section 6103(p)(4) of the IRC, while also satisfying section 6103(p)(4) of the IRC. In addition, commenters pointed out that some of the provisions of section 6103(p)(4) could not reasonably be imposed on non-government actors, because, for example, in contrast to Federal Tax Information, Limited Access DMF under Section 203 is not subject to restriction when beyond the three-calendar-year period following the date of death.

To resolve this ambiguity and address these comments, NTIS interprets Section 203(b) of the Act as requiring Persons to certify that they have systems, facilities, and procedures in place that are “reasonably similar to” those required by section 6103(p)(4) of the IRC in order to become Certified Persons. This interpretation allows NTIS to meet the interest of protecting personal data generally and deterring fraud, while also allowing NTIS to set the data integrity standards appropriate to safeguard Limited Access DMF specifically. The final rule amends § 1110.102(a)(2) and (3) accordingly.

A number of commenters suggested that the final rule should expressly classify certain categories of activities or enterprises, such as health care research and insurance investigation, as “a legitimate fraud prevention interest” or “a legitimate business purpose.” Other commenters suggested that the final rule should specifically provide that when an applicant or Certified Person is subject to other laws governing the use of personal information, the applicant or Certified Person should for that reason be deemed to have a “legitimate fraud prevention interest” or “legitimate business purpose.” It was urged that codification of such categories would further the purpose of the Act and benefit businesses and other entities reliant upon the LADMF by eliminating the threat of interrupted access. NTIS has carefully considered these suggestions, and observes that each Person applying for certification must certify to NTIS that such Person satisfies each of three requirements specified under Section 203(b)(2) of the Act, and that NTIS will evaluate each application individually to ensure that an individual applicant is properly certified. NTIS does acknowledge that it received numerous comments to the effect that awardees of federal research grants and others conducting extramural and intramural research under federal programs should be eligible for certification, provided that they otherwise satisfy the requirements of the final rule. NTIS notes that, while it appreciates the commenters' position, such Persons must, like any applicants, demonstrate that they satisfy the requirements for LADMF access.

A commenter observed that use of the term “Accredited Certification Body” in the proposed rule could create confusion, particularly since the concept of “certification” appears and is used separately in the rule. Accordingly, the final rule uses the term “Accredited Conformity Assessment Body” rather than “Accredited Certification Body,” and NTIS uses the former term in the preamble as well.

A number of commenters urged that particular activities and enterprises, such as direct marketing and life insurance companies, should not be subject to DMF-related audits or required to obtain a written third party attestation, where such activities and enterprises are independently subject to regulatory scrutiny and must comply with the privacy security requirements of other laws, such as the Gramm-Leach-Bliley Act (GLBA), the Fair Credit Reporting Act (FCRA), and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). While NTIS will decline to exclude Persons from the requirement for attestation as part of the certification process under the final rule, and will decline to exclude Certified Persons from being subject to audit, NTIS emphasizes that it is NTIS's intent under this final rule that applicants and Certified Persons should not incur the burden or expense of a DMF-specific audit when they have already had, or will have, an appropriate independent assessment or audit performed for other purposes, including but not limited to those noted above. To this end, § 1110.503(c) of the final rule explicitly contemplates reliance upon a review or assessment or audit by an Accredited Conformity Assessment Body that was not conducted specifically or solely for the purpose of submission to NTIS. NTIS intends that when a review, assessment or audit has been or can be performed in the course of satisfying other Federal, state, tribal, or local government laws or regulations, such as those mentioned by commenters, or other regulatory or fiduciary requirements flowing from such laws or regulations, a Person or Certified Person will be able to rely upon that review, assessment or audit, to the extent that the requirements of the final rule are satisfied. In these circumstances, NTIS intends that it will accept an Accredited Conformity Assessment Body's attestation regarding a non-DMF audit, which attestation includes an explanation of the nature of that non-DMF audit and represents that, based on its review, the Accredited Conformity Assessment Body is satisfied that the LADMF security and safeguard requirements are met.

NTIS will not at this time accept the suggestion of some commenters to permit “self-assessments” or “a self-certified written attestation” in lieu of a written attestation from an independent Accredited Conformity Assessment Body. With respect to state and local government departments and agencies, which are included within the definition of Persons in the final rule, NTIS notes some commenters' concerns that the proposed rule could burden such departments and agencies given state-established information security and safeguarding procedures, and agrees with the recommendation of a commenter that it should accept written attestation from an independent state or local government Inspector General or Auditor General office.

Accordingly, provided that a state or local government Inspector General or Auditor General satisfies the requirements of the final rule for Accredited Conformity Assessment Bodies, new § 1110.501(a)(2) of the final rule provides that a state or local government office of Inspector General or Auditor General and a Person or Certified Person that is a department or agency of the same state or local government, respectively, are not considered to be owned by a common “parent” entity under § 1110.501(a)(1)(ii) for the purpose of determining independence, and attestation by the Inspector General or Auditor General will be possible.

With respect to comments urging that provision should be made for self-assessments and attestations by organizations having the capacity to perform assessments and audits, NTIS recognizes that some organizations have such capacity, and are able in exercising it to address safeguarding and security requirements under other laws and regulations. Accordingly, new § 1110.502 of the final rule provides that, in addition to “independent” Accredited Conformity Assessment Bodies, a Person or Certified Person may engage a “firewalled” Accredited Conformity Assessment Body, as defined in the final rule and with the approval of NTIS, under conditions, as defined in the rule, which ensure that concerns about independence and actual or apparent conflicts of interest or undue influence are satisfactorily addressed.

Under new § 1110.502(a), a third party conformity assessment body must apply to NTIS for firewalled status if it is owned, managed, or controlled by a Person or Certified Person that is the subject of attestation or audit by the Accredited Conformity Assessment Body, applying the characteristics set forth under § 1110.501(a)(1) for independence. Under new § 1110.502(b), NTIS will accept an application for firewalled status when it finds that: (1) Acceptance of the third party conformity assessment body for firewalled status would provide equal or greater assurance that the Person or Certified Person has information security systems, facilities, and procedures in place to protect the security of the Limited Access DMF than would the Person's or Certified Person's use of an independent third party third party conformity assessment body; and (2) the third party conformity assessment body has established procedures to ensure that: (1) Its attestations and audits are protected from undue influence by the Person or Certified Person that is the subject of attestation or audit by the Accredited Conformity Assessment Body, or by any other interested party; (2) NTIS is notified promptly of any attempt by the Person or Certified Person that is the subject of attestation or audit by the third party conformity assessment body, or by any other interested party, to hide or exert undue influence over an attestation, assessment or audit; and (3) allegations of undue influence may be reported confidentially to NTIS. To the extent permitted by Federal law, NTIS will undertake to protect the confidentiality of witnesses reporting allegations of undue influence. Under new § 1110.502(c), NTIS will review each application and may contact the third party conformity assessment body with questions or to request submission of missing information, and will communicate its decision on each application in writing to the applicant.

Some commenters expressed concern that in attesting to its credentials under § 1110.503(a), an Accredited Conformity Assessment Body must indicate that it is accredited to a nationally or internationally recognized standard such as the ISO/IEC Standard 27006-2011 or any other similar recognized standard for bodies providing audit and certification for information security management systems, pointing to other potentially applicable standards, such as the American Institute of Public Accountants (AICPA) Service Organization Control Report (SOC) Type 2 Audit Report. NTIS wishes to emphasize that it is not NTIS's intent, in reciting ISO/IEC 27006-2011, to exclude from consideration AICPA SOC2 or other appropriate accreditation standards. The regulation identifies the ISO/IEC standard as one example of an acceptable national or international accreditation standard. NTIS selected the ISO/IEC standard, as noted in the original discussion of the proposed rule, to serve “as a baseline for accreditation,” because it was prepared by the International Organization for Standardization (ISO) Committee on conformity assessment (79 FR at 78316). Moreover, NTIS emphasized that it is “is aware that standards other than ISO/IEC 27006-2001 exist that may be equally appropriate for the purposes of accreditation under the Act, and that additional standards may be developed in the future . . . an [Accredited Conformity Assessment Body] may attest, subject to the conditions of verification in [final rule] Section 1110.503, that it is accredited to a nationally or internationally recognized standard for management systems other than ISO/IEC Standard 27006-2011.” NTIS further observes that the burden rests with the Person or Certified Person to identify and submit an attestation by an Accredited Conformity Assessment Body certified or credentialed by an appropriate accrediting body. Accordingly, NTIS concludes that § 1110.503(a) provides appropriate guidance as to the accreditation standard for Accredited Conformity Assessment Bodies.

A few commenters suggested that NTIS should directly accredit Accredited Conformity Assessment Bodies to conduct assessments and audits or provide a list of acceptable accreditations for Accredited Conformity Assessment Bodies. NTIS does not intend to do so. Recognized professional accreditation organizations with well-established, rigorous accreditation processes already exist in the private sector. Such organizations have either adopted or established nationally and internationally accepted standards for entities which may serve as Accredited Conformity Assessment Bodies under the final rule. In considering how to establish a permanent certification program as required under Section 203, NTIS carefully considered developing, within the agency, the capacity to evaluate the information systems, facilities and procedures of Persons to safeguard Limited Access DMF, as well as to conduct audits of Certified Persons and to itself accredit conformity assessment bodies. NTIS has consulted with the National Institute of Standards and Technology (NIST), which has expertise in testing, standard setting, certification and conformity assessment. Based on NIST recommendations, NTIS believes it appropriate for private sector, third party, Accredited Conformity Assessment Bodies to attest to a Person's information security safeguards under § 1110.102(a)(2) of the rule, for NTIS to rely upon such attestation in certifying a Person under the final rule, and for NTIS to rely as well upon third party, private sector accreditation of Accredited Conformity Assessment Bodies, while reserving to itself the ability to perform assessments and audits itself, in its discretion.

A number of commenters expressed concerns regarding the identification, in § 1110.502(b) of the proposed rule, of the “Limited Access Death Master File Publication 100” (Publication 100) as a source of guidance to which an Accredited Conformity Assessment Body could refer in its attestation as to the adequacy of an applicant's or Certified Person's safeguards for Limited Access DMF. These commenters stated that, even though Publication 100 is intended to set forth recommended guidelines, procedures and best practices, reference to that publication in the proposed rule implied a limitation to those safeguarding approaches set forth in Publication 100. These commenters offered other sources of security requirements for personal information they thought were pertinent and should be expressly included in the rule, such as the security standards for the GLBA.

NTIS notes, however, that the language of the rule makes clear that Publication 100 merely offers an example of security controls and protocols that an applicant or Certified Person may use, and is not intended to be prescriptive (79 FR at 78316). Moreover, NTIS recognizes that “a number of different approaches exist to safeguarding information.” Id. In the December 2014 Draft Version of Publication 100, NTIS stated:

Nevertheless, in response to commenters' concerns, NTIS has removed reference to Publication 100 from § 1110.503(b) of the final rule. Given the continuously evolving nature of information technology security and safeguard guidelines, procedures and best practices, NTIS intends that Publication 100 will be a living document. NTIS has invited comments on Publication 100 from the public on an ongoing basis, and contemplates interactive public dialog regarding its contents.

The proposed rule introduced a “safe harbor” provision in § 1110.200(c) that would exempt from penalty a first Certified Person who discloses LADMF to a second Certified Person, where the first Certified Person's liability rests solely on the fact that the second Certified Person has been determined to be subject to penalty. The provision was specifically drafted to apply to each disclosure and to limit the presumption of compliance to the first Certified Person, while the second Certified Person (i.e., the recipient of the LADMF) remained subject to penalty for violations of the Act (79 FR at 78317.) NTIS invited comments as to whether the “safe harbor” provision should be extended to circumstances where the recipient is believed to be certified but, in fact, is not. NTIS did not receive comment on this point. A Certified Person desiring to rely upon the “safe harbor” provision as set forth in this final rule will bear responsibility for ensuring that a recipient of LADMF is, in fact, a Certified Person at the time of disclosure. NTIS notes that it maintains and publishes a list of Certified Persons, available at https://dmf.ntis.gov.

NTIS received many comments suggesting that it should promulgate a broader “safe harbor” for a Certified Person who discloses LADMF to Persons whom the Certified Person knows are not certified (“uncertified Persons”). Many commenters urged that, unless the final rule made further allowance for Certified Persons to share LADMF with uncertified Persons, the commenters' businesses would suffer and their clients or other users would be deprived of data they need for critical purposes including fraud prevention, record-keeping and meeting legal and regulatory obligations. Many of these commenters also urged the extension of the “safe harbor” to Certified and uncertified Persons under certain circumstances, such as where an uncertified Person attests in writing that it meets the requirements for certification and to disclose the LADMF only to other uncertified Persons who could also meet the requirements, or where private contractual obligations were incurred. Some commenters contended that it would be unreasonable and unrealistic for NTIS to require their clients or other users to become certified and thus be subject to the rule's security and auditing requirements.

NTIS will not extend the “safe harbor” provision of § 1110.102(c) in this manner. However, NTIS emphasizes that Certified Person status has not been and is not required in order for a Certified Person to disclose LADMF to another Person. A Certified Person may, without penalty under § 1110.200 (but without “safe harbor” protection), disclose LADMF to another Person who, although not certified, meets the requirements of § 1110.102(a)(1) through (3), and who does not misuse or further disclose the LADMF in violation of § 1110.200(a)(1)(ii) or (iii). Indeed, many of the comments described above reflect the types of procedures that Certified Persons have successfully adopted under the Temporary Certification Program, and might be expected to adopt successfully in disclosing LADMF to uncertified Persons under the final rule. However, under such circumstances not involving a certified recipient, NTIS will not apply a “safe harbor” such as is applied under the final rule to a Certified Person who discloses Limited Access DMF to another who is also a Certified Person.

A few commenters were critical of the appeals process set forth in § 1110.300. One commenter opined that entities facing potential liability through “unscheduled audits” and “substantial financial penalties” needed “well-developed procedural rights” such as the right of appeal to an administrative law judge and federal court. NTIS has carefully considered these comments, but concludes that the process and procedures set forth in § 1110.300 are legally sufficient. NTIS has provided an appropriate administrative and appeal process in § 1110.300. Pursuant to the Administrative Procedure Act (Pub. L. 79-404, 60 Stat. 237), any Person or Certified Person can seek review of any adverse action or decision by the Director of NTIS in federal district court.

A comment was received suggesting that the exclusion of Executive departments or agencies of the United States Government from the definition of “Persons,” noted initially under the interim final rule and continued in the proposed rule, should be extended as well to the governments of foreign countries. NTIS has carefully considered this comment, but will not adopt such a categorical exclusion. NTIS will continue to consider applications by foreign governments on a case-by-case basis, in accordance with general principles of comity and consistent with the purposes of Section 203 and the requirements of the final rule.

This final rule amends subparts A, B, C, D, and adds a new subpart E to the DMF Certification Program in part 1110 of title 15 of the Code of Federal Regulations. The following describes specific provisions being amended.

Under § 1110.2, “Definitions,” NTIS is revising the definition of “Person” to recite “state and local government departments and agencies,” so that “Person” will be defined as including corporations, companies, associations, firms, partnerships, societies, joint stock companies, and other private organizations, and state and local government departments and agencies, as well as individuals. However, Executive departments or agencies of the United States Government will not be considered “Persons” for the purposes of this rule. Accordingly, Executive departments or agencies will not have to complete the Certification Form as set forth in the rule, and will be able to access Limited Access DMF under a subscription or license agreement with NTIS, describing the purpose(s) for which Limited Access DMF is collected, used, maintained and shared. Those working on behalf of and authorized by Executive departments or agencies may access the Limited Access DMF from their sponsoring Executive department or agency, which will be responsible for ensuring that such access is solely for the authorized purposes described by the agency. Unauthorized secondary use of Limited Access DMF by Executive departments or agencies or those working for them or on their behalf is prohibited. If an Executive department or agency wishes those working on its behalf to access the Limited Access DMF directly from NTIS, then those working on behalf of that Executive department or agency will be required to complete and submit the Certification Form as set forth in the rule and enter into a subscription agreement with NTIS in order to directly access the Limited Access DMF. Under this final rule, a Certified Person will be eligible to access the Limited Access DMF made available by NTIS through subscription or license.

The final rule adds a requirement that, in order to become certified, a Person must submit a written attestation from an Accredited Conformity Assessment Body, as defined in the final rule, that such Person has information security systems, facilities, and procedures in place to protect the security of the Limited Access DMF, as required under § 1110.102(a)(2) of the rule. NTIS has consulted with NIST, which has expertise in testing, standard-setting, and certification of various systems. Based on NIST recommendations, the final rule provides for private sector, third party, Accredited Conformity Assessment Bodies to attest to a Person's information security safeguards under § 1110.102(a)(2) of the rule, and NTIS will rely upon such attestation in certifying a Person under the final rule. The final rule also provides for Accredited Conformity Assessment Bodies to conduct periodic scheduled and unscheduled audits of Certified Persons on behalf of NTIS.

Under the final rule, an “Accredited Conformity Assessment Body” is defined as an independent third party conformity assessment body that is not owned, managed, or controlled by a Person or Certified Person which is the subject of attestation or audit, and that is accredited by an accreditation body under nationally or internationally recognized criteria such as, but not limited to, ISO and the International Electrotechnical Commission (IEC) publication ISO/IEC 27006-2011, “Information technology—Security techniques—Requirements for bodies providing audit and certification of information security management systems,” to attest that a Person or Certified Person has information technology systems, facilities and procedures in place to safeguard Limited Access DMF. Based on NIST recommendations, NTIS believes it is appropriate to reference the ISO/IEC 27006-2001 as an exemplary baseline for accreditation under the final certification program. The ISO Committee on conformity assessment (CASCO) prepared ISO/IEC 27006-2001, and reference to the ISO/IEC standard will help ensure that attestations and audits under the final certification program operate in a manner consistent with national and international practices. Accreditation is a third-party attestation that a conformity assessment body operates in accordance with national and international standards. Accreditation is used nationally and internationally in many sectors where there is a need, through certification, for safety, health or security requirements to be met by products or services. Accreditation ensures that a conformity assessment body is technically competent in the subject matter (in this case, the information safeguarding and security requirements as set forth in the rule) and has a management system in place to ensure competency and acceptable certification program operations on a continuing basis. Accreditation requires that Accredited Conformity Assessment Bodies be re-accredited on a periodic basis.

However, NTIS also acknowledges that standards other than ISO/IEC 27006-2001 exist that are equally appropriate for the purposes of accreditation under the Act, and that additional appropriate standards may be developed in the future. The final rule provides that an Accredited Conformity Assessment Body may attest, subject to the conditions of verification in § 1110.503 of the final rule, that it is accredited to a nationally or internationally recognized standard for bodies providing audit and certification of information security management systems other than ISO/IEC Standard 27006-2011. In addition, the rule provides that an Accredited Conformity Assessment Body must also attest that the scope of its accreditation encompasses the information safeguarding and security requirements as set forth in the rule.

NTIS is aware that security and safeguarding of information and information systems is of great concern in many fields of endeavor other than with respect to Limited Access DMF. NTIS has consulted with subject matter experts from NIST, which in 2014 published the “Framework for Improving Critical Infrastructure Cybersecurity” 1 (Framework), in response to President Obama's Executive Order 13636, “Improving Critical Infrastructure Cybersecurity,” which established that “[i]t is the Policy of the United States to enhance the security and resilience of the Nation's critical infrastructure and to maintain a cyber environment that encourages efficiency, innovation, and economic prosperity while promoting safety, security, business confidentiality, privacy, and civil liberties.” In articulating this policy, the Executive Order calls for the development of a voluntary risk-based Cybersecurity Framework—a set of industry standards and best practices to help organizations manage cybersecurity risks. The resulting Framework, created by NIST through collaboration between government and the private sector, uses a common language to address and manage cybersecurity risks in a cost-effective way based on business needs without placing additional regulatory requirements on businesses. The Framework enables organizations—regardless of size, degree of cybersecurity risk, or cybersecurity sophistication—to apply the principles and best practices of risk management to improving the security and resilience of critical infrastructure. The Framework provides organization and structure to today's multiple approaches to cybersecurity by assembling standards, guidelines, and practices that are working effectively in industry today. Accordingly, in addressing the requirements of Section 203 for “systems, facilities, and procedures” to safeguard Limited Access DMF, NTIS contemplates that Persons, as well as Accredited Conformity Assessment Bodies, may look to the Framework and to the Framework's Informative References. The Framework is referenced by NTIS in Publication 100. As set forth in Publication 100, as well as in the Framework's Informative References, a number of different approaches exist to safeguarding information. These include ISO/IEC, Control Objectives for Information and Related Technology (COBIT), International Society of Automation (ISA), and NIST's 800 series publications. Others include the Service Organization Controls (SOC) of the American Institute of CPAs (AICPA).

NTIS is aware that security and safeguarding assessments such as those contemplated under this final rule are routinely carried out in the private sector, including by entities which may satisfy the requirements for Accredited Conformity Assessment Bodies under the rule. Provided that such a routine assessment or audit of a Person would permit an Accredited Conformity Assessment Body to attest that such Person has systems, facilities, and procedures in place to safeguard Limited Access DMF as required under § 1110.102(a)(2) of the final rule, albeit carried out for a purpose other than certification under the rule, NTIS will accept an attestation in support of a Person's certification with respect to the requirements under § 1110.102(a)(2) of the rule, as well as in support of the renewal of a Certified Person's certification. The final rule provides that any attestation, whether for a Person seeking certification or for a Certified Person seeking renewal, must be based on the Accredited Conformity Assessment Body's review or assessment conducted no more than three years prior to the date of submission of the Person's completed certification statement or of the Certified Person's completed renewal certification statement. As noted, an Accredited Conformity Assessment Body's review or assessment need not have been conducted specifically or solely for the purpose of submission of an attestation under the final rule. From NTIS's consultations with NIST subject matter experts, NTIS believes that the limitation of three years is appropriate as to frequency for assessments for the security and safeguarding of information and information systems, and that permitting Persons and Certified Persons to rely on attestations based on such assessments conducted for purposes other than solely for the rule is reasonable and cost-effective.

Persons previously certified under the interim final rule will need to become certified in accordance with the requirements of this final rule, when it becomes effective. Certification under this final rule will include an updated certification form (NTIS FM161), discussed under the heading, “Paperwork Reduction Act,” collecting additional information that will improve NTIS's ability to determine whether a Person meets, to the satisfaction of NTIS, the requirements of Section 203 of the Act.

Under § 1110.103 of the final rule, a Certified Person may disclose Limited Access DMF to another Certified Person, and will be deemed to satisfy the disclosing Certified Person's obligation to ensure compliance with final § 1110.102(a)(4)(i)-(iii) for the purposes of certification. Similarly, under § 1110.200(c), NTIS will not impose a penalty, under § 1110.200(a)(1)(i)-(iii) of the final rule, on a first Certified Person who discloses Limited Access DMF to a second Certified Person, where the first Certified Person's liability rests solely on the fact that the second Certified Person has been determined to be subject to penalty. While the final rule does not restrict disclosure of Limited Access DMF to Certified Persons, these provisions create an appropriately limited “safe harbor” for Certified Persons to disclose Limited Access DMF to other Certified Persons. However, note that any Person, including any Certified Person, who receives Limited Access DMF from a Certified Person, is still subject to penalty under § 1110.200(a)(2), for violations of the Act. The safe harbor provision applies to each disclosure individually, and only the Certified Person disclosing the information, not the Certified Person recipient, receives the benefit of the presumed compliance with § 1110.102(a)(4)(i)-(iii).

Under § 1110.201 of the final rule, NTIS may conduct, or may request that an Accredited Conformity Assessment Body conduct, at the Certified Person's expense, periodic scheduled and unscheduled audits of the systems, facilities, and procedures of any Certified Person relating to such Certified Person's access to, and use and distribution of, the Limited Access DMF. NTIS contemplates that many, if not most, audits of Certified Persons will be scheduled, but NTIS may also conduct, or request an Accredited Conformity Assessment Body conduct, unscheduled audits—for example, where a prior scheduled audit may have identified the need for adjustment to a Certified Person's systems, facilities, or procedures. Audits conducted by NTIS or by an Accredited Conformity Assessment Body may take place at a Certified Person's place of business (i.e., field audits), or may be conducted remotely (i.e., desk audits). The final rule provides that all Certified Persons be audited with respect to the requirements of § 1110.102(a)(2) no less frequently than every three years under the program, and this requirement may be satisfied by a Certified Person based on an audit or assessment conducted for a purpose other than solely for the purpose of this program. The final rule does not require that Certified Persons undergo routine scheduled audits on the attestation regarding § 1110.102(a)(1), but does provide that unscheduled audits of this and other aspects of the requirements for certification may be conducted at NTIS's discretion. Under the final rule, NTIS' costs for conducting audits will be recoverable from the audited Person. Failure to submit to an audit, to cooperate fully with NTIS in its conduct of an audit or an Accredited Conformity Assessment Body conducting an audit on NTIS's request, or to pay an audit fee owed to NTIS, are grounds for revocation of certification under the final rule. NTIS intends that a Person or Certified Person will be directly responsible to an Accredited Conformity Assessment Body for any charges by that Accredited Conformity Assessment Body related to requirements under this final rule, as it would be responsible for NTIS' auditing costs under the Act.

Section 1110.200(a)(2) and (b) of the final rule set out the penalties for unauthorized disclosures or uses of the Limited Access DMF. Each individual unauthorized disclosure is punishable by a fine of $1,000, payable to the United States Treasury. However, the total amount of the penalty imposed under this part on any Person for any calendar year shall not exceed $250,000, unless such Person's disclosure or use is determined to be willful or intentional. A disclosure or use is considered willful when it is a “voluntary, intentional violation of a known legal duty.” See U.S. v. Pomponio, 429 US 10 (1976) (holding that for purposes of interpreting the criminal tax provisions of the Internal Revenue Code, the term “willful” means a voluntary, intentional violation of a known legal duty).

The final rule's § 1110.300 establishes the procedures to appeal a denial or revocation of certification, or the imposition of penalties for violating the Act. An administrative appeal must be filed, in writing, within 30 days (or such longer period as the Director of NTIS may, for good cause shown in writing, establish in any case) after receiving a notice of denial, revocation or imposition of penalties. Appeals are to be directed to the Director of NTIS. Any such appeal must set forth the following: The name, street address, email address and telephone number of the Person seeking review; a copy of the notice of denial or revocation of certification, or the imposition of penalty, from which appeal is taken; a statement of arguments, together with any supporting facts or information, concerning the basis upon which the denial or revocation of certification, or the imposition of penalty, should be reversed; and a request for hearing of oral argument before a representative of the Director, if desired.

Section 1110.300(a)-(d) sets forth the procedures for an administrative appeal. Under § 1110.300(c), a Person may, but need not, retain an attorney to represent such Person in an appeal. A Person must designate an attorney by submitting to the Director of NTIS a written power of attorney. If a hearing is requested, the Person (or the Person's designated attorney) and a representative of NTIS familiar with the notice from which appeal has been taken will present oral arguments which, unless otherwise ordered before the hearing begins, will be limited to thirty minutes for each side. A Person need not retain an attorney or request an oral hearing to secure full consideration of the facts and the Person's arguments. Where no hearing is requested, the Director shall review the case and issue a decision, as set out below.

Under § 1110.300(e), the Director of NTIS shall issue a decision on the matter within 120 days after a hearing, or, if no hearing was requested, within 90 days of receiving the letter of appeal. In making decisions on appeal, the Director shall consider the arguments and statements of fact and information in the Person's appeal, and made at the oral argument hearing, if such was requested, but the Director at his or her discretion and with due respect for the rights and convenience of the Person and the agency, may call for further statements on specific questions of fact, or may request additional evidence in the form of affidavits on specific facts in dispute. An appellant may seek reconsideration of the decision, but must do so in writing, and the request for reconsideration must be received within 30 days of the Director's decision or within such an extension of time thereof as may be set by the Director of NTIS before the original period expires. A decision shall become final either after the 30-day period for requesting reconsideration expires and no request has been submitted, or on the date of final disposition of a decision on a petition for reconsideration.

Under § 1110.500 of the final rule, an Accredited Conformity Assessment Body must be independent of the Person or Certified Person seeking certification, unless it is a third party conformity assessment body which a Certified Person has qualified for “firewalled” status pursuant to § 1110.502, and must itself be accredited by a recognized accreditation body. The requirement for independence from the Person seeking certification, or from the Certified Person seeking renewal or subject to audit, is important to ensure integrity of any assessment and attestation or audit. The final rule provides that an Accredited Conformity Assessment Body must be an independent third party conformity assessment body that is not owned, managed, or controlled by a Person or Certified Person that is the subject of attestation or audit by the Accredited Conformity Assessment Body, except where the third party conformity assessment body qualifies for “firewalled” status under § 1110.502.

Accordingly, under the final rule, a Person or Certified Person is considered to own, manage, or control a third party conformity assessment body if the Person or Certified Person holds a 10 percent or greater ownership interest, whether direct or indirect, in the third party conformity assessment body; if the third party conformity assessment body and the Person or Certified Person are owned by a common “parent” entity; if the Person or Certified Person has the ability to appoint a majority of the third party conformity assessment body's senior internal governing body, the ability to appoint the presiding official of the third party conformity assessment body's senior internal governing body, and/or the ability to hire, dismiss, or set the compensation level for third party conformity assessment body personnel; or if the third party conformity assessment body is under a contract to the Person or Certified Person that explicitly limits the services the third party conformity assessment body may perform for other customers and/or explicitly limits which or how many other entities may also be customers of the third party conformity assessment body.

In order for NTIS to accept an attestation as to, or audit of, a Person or Certified Person submitted to NTIS under the final rule, the Accredited Conformity Assessment Body must attest that it is independent of that Person or Certified Person. The Accredited Conformity Assessment Body also must attest that it has read, understood, and agrees to the regulations as set forth in the final rule. The Accredited Conformity Assessment Body must also attest that it is accredited to ISO/IEC Standard 27006-2011 “Information technology—Security techniques—Requirements for bodies providing audit and certification of information security management systems,” or to another nationally or internationally recognized standard for bodies providing audit and certification of information security management systems. The Accredited Conformity Assessment Body must also attest that the scope of its accreditation encompasses the safeguarding and security requirements as set forth in the final rule.

Where review or assessment or audit by an Accredited Conformity Assessment Body was not conducted specifically or solely for the purpose of submission under this part, the final rule requires that the written attestation or assessment report (if an audit) describe the nature of that review or assessment or audit, and that the Accredited Conformity Assessment Body attest that on the basis of such review or assessment or audit, the Person or Certified Person has systems, facilities, and procedures in place to safeguard Limited Access DMF as required under § 1110.102(a)(2).

While NTIS will normally accept written attestations and assessment reports from an Accredited Conformity Assessment Body that attests, to the satisfaction of NTIS, as provided in § 1110.503 of the final rule, the final rule also provides that NTIS may decline to accept written attestations or assessment reports from an Accredited Conformity Assessment Body, whether or not it has attested as provided in § 1110.503, for any of the following reasons: when NTIS determines that doing so is in the public interest under Section 203 of the Bipartisan Budget Act of 2013, and notwithstanding any other provision of these regulations; submission of false or misleading information concerning a material fact(s) in an Accredited Conformity Assessment Body's attestation under § 1110.503; knowing submission of false or misleading information concerning a material fact(s) in an attestation or assessment report by an Accredited Conformity Assessment Body of a Person or Certified Person; failure of an Accredited Conformity Assessment Body to cooperate (as defined in this section) in response to a request from NTIS to verify the accuracy, veracity, and/or completeness of information received in connection with an attestation under § 1110.503 or an attestation or assessment report by that Body of a Person or Certified Person; or where NTIS is unable for any reason to verify the accuracy of the Accredited Conformity Assessment Body's attestation.

In addition, with respect to audits under the final rule, NTIS may in its discretion decline to accept an attestation or assessment report conducted for other purposes, and may conduct or require that an Accredited Conformity Assessment Body conduct a review solely for the purpose of the final rule.

This final rule has been determined to be significant as that term is defined in Executive Order 12866.

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on States or localities. NTIS has analyzed this rule under that Order and has determined that it does not have implications for federalism.

The Regulatory Flexibility Act of 1980, as amended, (RFA), requires agencies to analyze impacts of regulatory actions on small entities (businesses, non-profit organizations, and governments), and to consider alternatives that minimize such impacts while achieving regulatory objectives. Agencies must first conduct a threshold analysis to determine whether regulatory actions are expected to have significant economic impact on a substantial number of small entities. If the threshold analysis indicates a significant economic impact on a substantial number of small entities, an initial regulatory flexibility analysis must be produced and made available for public review and comment along with the proposed regulatory action. A final regulatory flexibility analysis that considers public comments must then be produced and made publicly available with the final regulatory action.

An Initial Regulatory Flexibility Act Analysis (“IRFA”) was incorporated into the NTIS proposed rule. NTIS sought written public comment on the proposed rule, including comment on the IRFA. This Final Regulatory Flexibility Act Analysis (“FRFA”) conforms to the RFA, and incorporates the IRFA pursuant to Section 603 and comments received, to analyze the impact that this final rule will have on small entities.

The policy reasons for issuing this rule are discussed in the preamble of this document, and not repeated here.

The legal basis for this rule is Section 203 of the Bipartisan Budget Act of 2013, Pub. L. 113-67, codified at 42 U.S.C. 1306c (the Act). The rule, which replaces NTIS' interim final rule, implements the Act, which requires the Secretary of Commerce to create a program to certify that persons given access to the Limited Access DMF satisfy the statutory requirements for accessing that information. Accordingly, this rule creates a permanent program for certifying persons eligible to access Limited Access DMF. It requires that Certified Persons annually re-certify as eligible to access the Limited Access DMF, and that they agree to be subject to scheduled and unscheduled audits. The rule also sets out the penalties for violating the Act's disclosure provisions, establishes a process to appeal penalties or revocations of certification, and adopts a fee program for the certification program, audits, and appeals.

When this final rule becomes effective, it will replace the interim final rule promulgated by NTIS to establish a Temporary Certification Program, in order to avoid the complete loss of access to the Limited Access DMF when the Act became effective. No other rules duplicate, overlap, or conflict with this rule.

The final rule applies to all persons seeking to become certified to obtain the Limited Access DMF from NTIS. The entities affected by this rule could include banks and other financial institutions, pension plans, health research institutes or companies, state and local governments, information companies, and similar research services, and others not identified. Many of the impacted entities likely are considered “large” entities under the applicable United States Small Business Administration (SBA) size standards. The SBA defines a “small business” (or “small entity”) as one with annual revenue that meets or is below an established size standard. The SBA “small business” size standard is $550 million in annual revenue for Commercial Banking, Savings Institutions, Credit Unions, and Credit Card Issuing (North American Industry Code (NAICS) 522110, 522120, 522130, and 522210). The size standard is $38.5 million for Consumer Lending and Trust, Fiduciary and Custody Activities, and Direct Health and Medical Insurance Carriers (NAICS 52291, 523991, and 524114), $7.5 million for Mortgage and Nonmortgage Loan Brokers, and Insurance Agencies and Brokerages (NAICS 522310, and 524210), and $32.5 million for Third Party Administration of Insurance and Pension Funds (NAICS 524292). NTIS anticipates that this rule will have an impact on various small entities.

Under this final rule, a “Limited Access Death Master File (LADMF) Systems Safeguards Attestation Form” would require Accredited Conformity Assessment Bodies to attest that a Person seeking to be certified to access Limited Access DMF has systems, facilities, and procedures in place as required under § 1110.102(a)(ii) of the rule. NTIS estimates that the type of professional skills necessary for the preparation of an attestation will be those of a senior auditor at an Accredited Conformity Assessment Body, to conduct an assessment under the rule.

NTIS carefully considered a number of alternatives to ensure compliance with the safeguarding requirements of Section 203 of the Act. These alternatives included requiring all Persons desiring to become certified to comply with the same requirements as those set forth in Section 6103(p)(4) of the Internal Revenue Code; Section 203(b)(2)(C) of the Act recites that a Certified Person “satisfy the requirements of such section 6103(p)(4) as if such section applied to such person.” Such a requirement would have had a very significant impact on small entities. As pointed out in some comments on the proposed rule, some of the provisions of section 6103(p)(4) would have been extremely burdensome, because, for example, in contrast to Federal Tax Information, Limited Access DMF under Section 203 is not subject to restriction when beyond the three-calendar-year period following the date of death.

Accordingly, NTIS rejected this burdensome alternative, and the final rule instead requires Persons to certify that they have systems, facilities, and procedures in place that are “reasonably similar to” those required by section 6103(p)(4) of the IRC in order to become Certified Persons. This interpretation allows NTIS to meet the interest of protecting personal data generally and deterring fraud, while also allowing NTIS to set the data integrity standards appropriate to safeguard Limited Access DMF specifically, and lessens the burden on small entities which, as noted by a number of commenters, tend not to have in place some more advanced information system controls.

NTIS carefully considered, but rejected, the alternative of requiring Certified Persons to undergo audits annually for the purpose of re-certification. This alternative would have necessitated that a Certified Person bear the expense of assessment for the purpose of attestation by a third party Accredited Conformity Assessment Body each year as part of the annual re-certification process under the rule. Based on consultations with NIST subject matter experts, NTIS concluded instead that a limitation of three years is appropriate as to frequency for assessments for the security and safeguarding of information and information systems, thus lessening the economic impact on small entities under the rule.

NTIS carefully considered, but rejected, the suggestion by a commenter that NTIS itself should accredit third party Accredited Conformity Assessment Bodies. This would have required that NTIS independently develop government-specific accreditation expertise and capacity. Because the Act requires NTIS to obtain full cost recovery, the cost of such an effort would have to be borne by Certified Persons, including small entities. This would have been inefficient as well as burdensome. Instead, the final rule provides that an Accredited Conformity Assessment Body attest that it is accredited to a nationally or internationally recognized standard for bodies providing audit and certification of information security management systems, and that the scope of its accreditation encompasses the information safeguarding and security requirements as set forth in the rule.

NTIS carefully considered, and rejected, a proposed requirement that Persons desiring to become certified under the rule be limited to program-specific assessments and audits carried out by third party Accredited Conformity Assessment Bodies. This requirement would have necessitated that any Person, including a Person otherwise subject to periodic audit and assessment in the normal course of such Person's business, bear the burden of an additional program-specific audit or assessment for the purposes of the rule. NTIS, however, in consultation with NIST subject matter experts, considered and adopted a less burdensome approach: Provided that a routine assessment or audit of a Person would permit an Accredited Conformity Assessment Body to attest that such Person has systems, facilities, and procedures in place to safeguard Limited Access DMF as required under § 1110.102(a)(2) of the final rule, albeit carried out for a purpose other than certification under the rule, NTIS will accept an attestation in support of a Person's certification with respect to the requirements under § 1110.102(a)(ii) of the rule, as well as in support of the renewal of a Certified Person's certification. Thus, under the final rule, an Accredited Conformity Assessment Body's review or assessment need not have been conducted specifically or solely for the purpose of submission of an attestation under the rule, reducing the economic impact that the rejected alternative would have been imposed on small entities.

NTIS carefully considered, but rejected, the alternative of requiring that a first Certified Person who discloses Limited Access DMF to a second Certified Person be subject to penalty under the rule where, through no fault of the first Certified Person, the second Certified Person is determined to be subject to penalty under the rule. This alternative would have exposed to penalty under the rule a first Certified Person, who disclosed Limited Access DMF to another Person certified by NTIS, even absent any violation by the first Certified Person. Instead, the Final Rule provides for a “safe harbor” that exempts from penalty a first Certified Person who discloses LADMF to a second Certified Person, where the first Certified Person's liability rests solely on the fact that the second Certified Person has been determined to be subject to penalty. The less burdensome approach chosen by NTIS will reduce the potential economic impact on Certified Persons, including those that are small entities, under such circumstances.

Based on its analysis, NTIS estimates that the rule reflects alternatives placing the least economic impact on small entities, and that the rule will not disproportionately impact small entities as opposed to large ones.

Notwithstanding any other provision of law, no person is required to comply with, and neither shall any person be subject to penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number.

This final rule contains collection of information requirements subject to review and approval by OMB under the Paperwork Reduction Act (PRA). Approval from OMB will be obtained prior to the final rule becoming effective and prior to the collection of such information, except that NTIS will continue to collect information already approved by OMB under OMB Control No. 0692-0013.

For reasons set forth in the preamble, the National Technical Information Service amends 15 CFR part 1110 as follows:

The Coast Guard will enforce the regulations in 33 CFR 100.1102 for a special local regulation for the annual Great Western Tube Float in 33 CFR 100.1102, Table 1, Item 9 from 7 a.m. to 4 p.m. on June 11, 2016.

Under the provisions of 33 CFR 100.1102, persons and vessels are prohibited from entering into, transiting through, or anchoring within this regulated area of the Colorado River unless authorized by the Captain of the Port, or his designated representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This document is issued under authority of 33 CFR 100.1102 and 5 U.S.C. 552 (a). In addition to this document in the Federal Register, the Coast Guard will provide the maritime community with extensive advance notification of this enforcement period via the Local Notice to Mariners and local advertising by the event sponsor.

If the Captain of the Port Sector San Diego or his designated representative determines that the regulated area need not be enforced for the full duration stated on this document, he or she may use a Broadcast Notice to Mariners or other communications coordinated with the event sponsor to grant general permission to enter the regulated area.

The Marine Parkway Bridge, mile 3.0, across the Rockaway Inlet, has a vertical clearance in the closed position of 55 feet at mean high water and 59 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.795(a).

The waterway is transited by commercial oil barge traffic of various sizes.

The bridge owner, MTA Bridges and Tunnels, requested a temporary deviation from the normal operating schedule to facilitate asbestos abatement in the machinery room at the bridge.

Under this temporary deviation, the Marine Parkway Bridge shall remain in the closed position from 7 a.m. on June 6, 2016 to 5 p.m. June 17, 2016.

Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation. The Coast Guard notified various companies of the commercial oil and barge vessels and they have no objections to 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.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0569 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 August 1, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0569, 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 October 21, 2015 (80 FR 63731) (FRL-9935-29), 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 5E8384) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of fluensulfone equivalents (i.e., the sum of thiazole sulfonic acid (TSA) and butene sulfonic acid (BSA) expressed as total fluensulfone equivalents) in or on the raw agricultural commodity vegetable, tuberous and corm, subgroup 1C at 0.6 ppm. That document referenced a summary of the petition prepared by Makhteshim Agan of North America, Inc., the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing, however it related to the chemical propenicol, not fluensulfone.

In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-86), 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 5F8351) by Makhteshim Agan of North America, Inc. (d/b/a ADAMA), 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of nematicide fluensulfone, including its metabolites and degradates, in or on berry, low growing, subgroup 13-07G at 0.30 ppm; head and stem Brassica subgroup 5A at 1.3 ppm; leafy Brassica greens subgroup 5B at 13 ppm; leafy vegetables, group 4, except Brassica vegetables at 2.6 ppm; leaves of root and tuber vegetables, group 2 at 20 ppm; radish, oriental at 0.50 ppm; and root vegetables, subgroup 1B, except sugar beet and oriental radish at 3.3 ppm. In addition, the petition requested to amend 40 CFR 180.680 to revise the existing tolerance expression in the introductory paragraph (a) to read “Tolerances are established for residues of the nematicide fluensulfone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only 3,4,4-trifluoro-but-3-ene-1-sulfonic acid.” That document referenced a summary of the petition prepared by Makhteshim Agan of North America, Inc., the registrant, which is available in the docket, EPA-HQ-OPP-2015-0478 at http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

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

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

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

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

The residue of concern for dietary assessment is the parent compound, fluensulfone. Residues of the metabolites butene sulfonic acid (BSA) and thiazole sulfonic acid (TSA) occur at levels significantly greater than fluensulfone; however, these metabolites are considered non-toxic at levels that may occur from the use of fluensulfone. Based on the available data addressing toxicity of the BSA and TSA metabolites, the Agency has determined that they are not of toxicological concern.

Exposure to fluensulfone results in effects on the hematopoietic system (decreased platelets, increased white blood cells, hematocrit, and reticulocytes), kidneys, and lungs. Body weight and clinical chemistry changes were observed across multiple studies and species. Evidence of qualitative increased susceptibility of infants and children to the effects of fluensulfone was observed in the 2-generation reproduction study in rats, wherein pup death was observed at a dose that resulted in body weight effects in the dams. There was no evidence of either qualitative or quantitative susceptibility in developmental toxicity studies in rats or rabbits.

The most sensitive endpoints for assessing safety of aggregate exposures to fluensulfone under the FFDCA are the increased pup-loss effects for acute dietary exposure; and body weight, hematological and clinical chemistry changes for chronic dietary as well as short/intermediate term dermal exposures.

Decreased locomotor activity in females, and decreased spontaneous activity, decreased rearing, and impaired righting response in both sexes were observed in the acute neurotoxicity study at the lowest dose tested. No other evidence for neurotoxicity was observed in the other studies in the toxicity database, including a subchronic neurotoxicity study. The doses and endpoints chosen for risk assessment are all protective of the effects seen in the acute neurotoxicity study. A developmental neurotoxicity study is not required.

Although the mouse carcinogenicity study showed an association with alveolar/bronchiolar adenomas and carcinomas in the female, EPA has determined that quantification of risk using the chronic reference dose (RfD) will account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluensulfone and its metabolites. That conclusion is based on the following considerations:

1. The tumors occurred in only one sex in one species.

2. No carcinogenic response was seen in either sex in the rat.

3. The tumors in the mouse study were observed at a dose that is almost 13 times higher than the dose chosen for risk assessment.

4. Fluensulfone and its metabolites are not mutagenic.

Specific information on the studies received and the nature of the adverse effects caused by fluensulfone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Fluensulfone—Aggregate Human Health Risk Assessment Addressing Label Amendments, Changes to the Residue Definition, and New Uses on Multiple Crops” on page 43 in docket ID number EPA-HQ-OPP-2015-0569.

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

A summary of the toxicological endpoints for fluensulfone 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 fluensulfone, EPA considered exposure under the petitioned-for tolerances as well as all existing fluensulfone tolerances in 40 CFR 180.680. Parent fluensulfone occurs at residue levels well below those of the BSA metabolite, the residue defined for the enforcement of tolerances. As previously noted, the BSA metabolite is not of toxicological concern. Since tolerances do not include fluensulfone itself, EPA has used the Organization for Economic Cooperation and Development (OECD) maximum residue limit (MRL) calculation procedures to derive tolerance-equivalent residue levels for fluensulfone. For foods where the level of fluensulfone is expected to be below the limit of quantification (LOQ), 0.01 ppm, the Agency has assumed that residues occur at the LOQ. For foods with quantifiable levels of fluensulfone, EPA has assumed that residues occur at the tolerance-equivalent level. EPA assessed dietary exposures from fluensulfone 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 fluensulfone. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, the acute dietary risk assumed tolerance-equivalent residues and 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption information from the USDA's NHANES/WWEIA. As to residue levels in food, the chronic dietary risk assumed tolerance-equivalent residues and 100 PCT.

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

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

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) for acute exposures are estimated to be 11.8 parts per billion (ppb) for surface water and 77.6 ppb for ground water and for chronic exposures are estimated to be 0.173 ppb for surface water and 52.5 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 77.6 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 52.5 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluensulfone is currently registered for the following uses that could result in residential exposures: Turf/lawns. EPA assessed residential exposure using the following assumptions: For residential handlers, a quantitative exposure/risk assessment was not developed because the product is not intended to be applied by homeowners. For adult residential post-application exposure, the Agency evaluated dermal post-application exposure only to outdoor turf/lawn applications (high contact activities). The Agency also evaluated residential post-application exposure for children via dermal and hand-to-mouth routes of exposure, resulting from treated outdoor turf/lawn applications (high contact activities).

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

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

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the 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. No evidence of quantitative or qualitative susceptibility was seen in developmental toxicity studies in rats and rabbits. Fetal effects in those studies occurred in the presence of maternal toxicity and were not considered more severe than the maternal effects. However, there was evidence of increased qualitative, but not quantitative, susceptibility of pups in the 2-generation reproduction study in rats. Maternal effects observed in that study were decreased body weight and body weight gain; at the same dose, effects in offspring were decreased pup weights, decreased spleen weight, and increased pup loss (PND 1-4).

Although there is evidence of increased qualitative susceptibility in the 2-generation reproduction study in rats, there are no residual uncertainties with regard to pre- and post-natal toxicity following in utero exposure to rats or rabbits and pre- and post-natal exposures to rats. Considering the overall toxicity profile, the clear NOAEL for the pup effects observed in the 2-generation reproduction study, and that the doses selected for risk assessment are protective of all effects in the toxicity database including the offspring effects, the degree of concern for the susceptibility is low.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

i. The toxicity database for fluensulfone is complete.

ii. Evidence of potential neurotoxicity was only seen following acute exposure to fluensulfone and the current PODs chosen for risk assessment are protective of the effects observed. There is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no indication of quantitative susceptibility in the developmental and reproductive toxicity studies, and there are no residual uncertainties concerning pre- or post-natal toxicity. In addition, the endpoints and doses chosen for risk assessment are protective of the qualitative susceptibility observed in the 2-generation reproduction study.

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

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 fluensulfone will occupy 9.3% of the aPAD for all infants less than 1 year 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 fluensulfone from food and water will utilize 3.9% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluensulfone is not expected.

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

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

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 5,700 for adults and 3,000 for children 1-2 years old. Because EPA's level of concern for fluensulfone 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).

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

5. Aggregate cancer risk for U.S. population. EPA assessed cancer risk using a non-linear approach (i.e., RfD) since it adequately accounts for all chronic toxicity, including carcinogenicity, that could result from exposure to fluensulfone. As the chronic dietary endpoint and dose are protective of potential cancer effects, fluensulfone is not expected to pose an aggregate cancer risk.

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 fluensulfone residues.

Adequate enforcement methodology (acetonitrile/water (1:1, v/v) extraction and analysis by reverse-phase high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS)) is available to enforce the tolerance expression.

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 any MRLs for fluensulfone for the commodities covered by this document.

Three comments were submitted in response to the March 16, 2016 Notice of Filing. Two of them opposed the petition generally due to there being too many toxic chemicals being used in America without citing any specific human health concerns about fluensulfone itself. The Agency understands the commenters' concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

The second comment was from the Center for Food Safety and primarily concerned about Agency compliance with any relevant obligations under the Endangered Species Act. This comment is not relevant to the Agency's evaluation of safety of the fluensulfone tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment.

Most of the petitioned-for tolerance levels differ from those being established by the Agency. In the cases of the tolerances proposed by ADAMA, it is not clear to the Agency how the tolerance levels proposed in the March 16, 2016 Notice of Filing (Federal Register 2016-05952) were derived. EPA's tolerance levels are based on residues of BSA only, without any conversion to fluensulfone equivalents. The Agency used the OECD MRL procedures to derive the levels being established in today's action. For crop groups, and per EPA's current policy, tolerance levels for each representative commodity were calculated separately, and then the maximum value within each crop group was selected as the tolerance level. For root vegetables except sugar beet (Subgroup 1B), the tolerance level is based on data from radish root (including Oriental radish root). Although a separate listing for Oriental radish was requested, EPA is not establishing a separate tolerance level since that crop is a member of crop subgroup 1B. For leaves of root and tuber vegetables (Crop Group 2), EPA is establishing a tolerance for residues in/on the leaves of root and tuber vegetable, except sugar beet because the petitioned-for uses do not include a use on sugar beet; the tolerance is based on data from radish tops (including Oriental radish tops). The tolerance for residues in/on leafy vegetables except Brassica vegetables (Group 4) is based on data from leaf lettuce and spinach, assessed separately. For head and stem Brassica (Subgroup 5A), the tolerance is based on data from cabbage. For Brassica leafy greens (Subgroup 5B), data from mustard greens, komatsuna (Japanese mustard spinach), and mizuna (Japanese mustard) were combined to derive the tolerance level. All of EPA's tolerance levels are expressed to provide sufficient precision for enforcement purposes, and this may include the addition of trailing zeros (e.g., 0.30 ppm rather than 0.3 ppm).

In the case of the tolerance proposed by IR-4, the petitioned-for tolerance is based on the sum of residues of BSA and TSA, expressed as fluensulfone, rather than on residues of BSA only, which is how the tolerance expression currently describes measurement of residues for compliance purposes. Basing enforcement on BSA alone provides a suitable marker of use, simplifies residue analysis, and avoids enforcement complications that may result from the potential for TSA to carry over in treated soil from one year to the next. Furthermore, IR-4 did not propose tolerances for residues of fluensulfone in processed potato commodities. The submitted potato processing study indicates that during processing, residues of BSA in chips and in granules/flakes are likely to concentrate to levels greater than in tubers. Therefore, EPA is establishing separate tolerances to cover residues in those commodities.

Therefore, tolerances are established for residues of fluensulfone in or on berry, low growing, subgroup 13-07G at 0.30 ppm; Brassica, head and stem, subgroup 5A at 1.50 ppm; Brassica, leafy greens, subgroup 5B at 9.0 ppm; potato, chips at 0.60 ppm; potato, granules/flakes at 0.80 ppm; vegetables, leafy, except Brassica, group 4 at 2.0 ppm; vegetable, leaves of root and tuber, group 2, except sugar beet at 30 ppm; vegetables, root, except sugar beet, subgroup 1B at 3.0 ppm; and vegetables, tuberous and corm, subgroup 1C at 0.50 ppm. Also, the time-limited Section 18 tolerance for “carrot” is removed since it is now covered by the permanent tolerance for “vegetables, root, except sugar beet, subgroup 1B.” And lastly, the tolerance expression is changed as requested by the petitioner.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 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 the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0212 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 August 1, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0212, 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 July 22, 2015 (80 FR 43373) (FRL-9929-12), EPA issued a proposed rule to revoke certain tolerances for acephate, aldicarb, azinphos-methyl, etridiazole, fenarimol, imazamethabenz-methyl, tepraloxydim, thiacloprid, thiazopyr, and tralkoxydim, and tolerance exemptions for certain pesticide active ingredients, in follow-up to canceled product registrations or uses. Also, EPA proposed to make minor revisions to the section heading and introductory text for Pythium oligandrum DV 74. In addition, in accordance with current Agency practice, EPA proposed to make minor revisions to the tolerance expression for imazamethabenz-methyl, and remove expired tolerances and tolerance exemptions for certain pesticide active ingredients. The proposal provided a 60-day comment period.

Since the proposed rule of July 22, 2015, amendments for the last two acephate labels with succulent bean use (revising succulent bean to a non-food use) were approved by EPA, as anticipated and discussed in the proposed rule. Therefore, EPA is revoking the acephate tolerances in 40 CFR 180.108(a)(1) and (a)(3) on bean, succulent.

In this final rule EPA is revoking certain tolerances and/or tolerance exemptions because either they are no longer needed or are associated with food uses that are no longer registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United States. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide active ingredient. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to issue a final rule revoking those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person comments on the proposal indicating a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or legally treated domestic commodities.

EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States.

Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies:

1. Prior to EPA's issuance of a FFDCA section 408(f) order requesting additional data or issuance of a FFDCA section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.

2. EPA independently verifies that the tolerance is no longer needed.

3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under the Food Quality Protection Act (FQPA).

Among the comments received by EPA are the following:

1. Aldicarb.—Comment by Ag Logic Chemical LLC (Ag Logic). The commenter requested that the aldicarb tolerances on sorghum be retained for possible future actions. Ag Logic stated that another registrant requested the voluntary cancellation of its aldicarb products for use on sorghum and now Ag Logic is the sole registrant for aldicarb. Also, Ag Logic stated it is reevaluating all current and potential agricultural uses for aldicarb and if it decides to apply for registration on sorghum it would be extremely beneficial to both Ag Logic and the Agency if the sorghum tolerances remained in place.

Agency response. The use of aldicarb on sorghum was officially canceled in 2009 (see details in the proposed rule of July 22, 2015) under section 6(f)(1) of FIFRA, 7 U.S.C. 136(d)(f)(1), under which a registrant of a pesticide product may request that the product registration be canceled or amended to terminate one or more uses. Because EPA canceled the sorghum use in response to a registrant's voluntary request, and no other aldicarb products include a use on sorghum, there is currently no legal use of aldicarb on sorghum. EPA will not retain the tolerance based on the possibility that someone may apply for a new use on sorghum in the future. Tolerances are generally maintained for current uses. In addition, no comment specific to the need for retaining tolerances for aldicarb residues of concern on sorghum for import purposes was received by the Agency during the 60-day comment period. Therefore, EPA is revoking the tolerances for aldicarb in 40 CFR 180.269(a) on sorghum, grain, bran; sorghum, grain, grain; and sorghum, grain, stover.

2. Thiacloprid.—Comments by Bayer CropScience (BCS), BCS in Mexico, Power Farms Inc., the Ontario Apple Growers (OAG), and the Ontario Fruit and Vegetable Growers' Association (OFVGA). The commenters requested that all the current tolerances for thiacloprid be retained for import purposes with the exception of the OFVGA, which asked that only the specific thiacloprid tolerances on pome fruit and wet apple pomace be maintained for import purposes. Also, BCS stated its intention to provide supporting data where necessary for all of the current thiacloprid tolerances.

Agency response. In comments to the proposed rule, persons expressed a need for retention of the thiacloprid tolerances for import purposes. Therefore, EPA will not revoke the thiacloprid tolerances in 40 CFR 180.594 at this time. However, because there are no longer any active food-use registrations in the United States and no comments were received by EPA which expressed a need for more time to exhaust existing stocks for domestic use, EPA is not changing its previous determination (as stated in the proposed rule of July 22, 2015) that existing stocks in the United States will be exhausted by February 8, 2017. EPA is noting in 40 CFR 180.594 that the tolerances for thiacloprid have no U.S. registrations as of August 6, 2014. Also, retaining these tolerances may require submission of data to demonstrate their safety. For example, domestic U.S. residue data may not be representative of growing conditions and use patterns in other countries. EPA published guidance on pesticide import tolerances and residue data for imported food in the Federal Register notices of April 5, 2006 (71 FR 17099) (FRL-7772-1) and June 1, 2000 (65 FR 35069) (FRL-6559-3).

With the exception of aldicarb and thiacloprid, the Agency did not receive any specific comments in the docket, during the 60-day comment period, concerning proposed tolerance actions associated with pesticide active ingredients, as described in the Federal Register of July 22, 2015. Therefore, with the exception of thiacloprid, EPA is finalizing revocations and amendments in the proposed rule of July 22, 2015. For a detailed discussion of the Agency's rationale for the finalized tolerance actions, refer to the proposed rule of July 22, 2015.

EPA may issue a regulation establishing, modifying, or revoking a tolerance under FFDCA section 408(e). In this final rule, EPA is revoking tolerances and tolerance exemptions as follow-up on canceled uses of pesticides.

As stated in the DATES section, this regulation is effective November 28, 2016. EPA is delaying the effective date of these finalized actions to allow a reasonable interval for producers in exporting members of the World Trade Organization's Sanitary and Phytosanitary Measures Agreement to adapt to the requirements of a final rule. With the exception of fenarimol, imazamethabenz-methyl, and thiacloprid, EPA believes that existing stocks of the canceled or amended pesticide products labeled for the uses associated with the revoked tolerances have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade. EPA is revoking certain tolerances for fenarimol, imazamethabenz-methyl, and tepraloxydim with expiration/revocation dates. EPA believes that these revocation dates allow users to exhaust stocks and allow sufficient time for passage of treated commodities through the channels of trade.

Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:

1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.

2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.

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 etridiazole, imazamethabenz-methyl, tepraloxydim, thiazopyr, and tralkoxydim.

The Codex has established MRLs for acephate, in or on various commodities, including beans, except broad bean and soya bean at 5 milligrams/kilogram (mg/kg). The beans, except broad bean and soya bean MRL is different than the tolerance established for acephate on succulent bean in the United States, which EPA is revoking in this final rule.

The Codex has established MRLs for aldicarb, in or on various commodities, including sorghum at 0.1 mg/kg, which is covered by a current U.S. tolerance at a higher level than the MRL, and sorghum straw and fodder, dry at 0.5 mg/kg, which is the same as the U.S. tolerance. The sorghum MRL is different than the tolerance established for aldicarb in the United States. In this final rule EPA is revoking the tolerances for aldicarb on sorghum, grain, bran; sorghum, grain, grain; and sorghum, grain, stover.

The Codex has established MRLs for azinphos-methyl in or on various commodities, including almond hulls and blueberries at 5 mg/kg, cherries, peach, and plums (including prunes) at 2 mg/kg, and walnuts at 0.3 mg/kg. These MRLs are the same as the tolerances established for azinphos-methyl in the United States. In this final rule EPA is revoking the tolerances for azinphos-methyl on almond, hulls; blueberry; cherry; peach; plum, prune; and walnut.

The Codex has established MRLs for azinphos-methyl, in or on various commodities, including almonds and apple at 0.05 mg/kg (which are covered by current U.S. tolerances at a higher level than the MRLs), and pear at 2 mg/kg. These MRLs are different than the tolerances established for azinphos-methyl in the United States. In this final rule EPA is revoking the tolerances for azinphos-methyl on almond; apple; and pear.

The Codex has established MRLs for fenarimol in or on various commodities, including cattle, liver at 0.05 mg/kg, cherries at 1 mg/kg, hops, dry at 5 mg/kg, and pecan at 0.02 mg/kg. These MRLs are the same as the tolerances established for fenarimol in the United States. In this final rule EPA is revoking the tolerances for fenarimol residues in or on cattle, meat byproducts, except kidney; cherry, sweet; cherry, tart; hop, dried cones; and pecan; each with an expiration/revocation date.

The Codex has established MRLs for fenarimol, in or on various commodities, including cattle kidney and cattle meat at 0.02 mg/kg; and grapes at 0.3 mg/kg. These MRLs are different than the tolerances established for fenarimol in the United States. In this final rule EPA is revoking the tolerances for fenarimol residues in or on cattle, kidney; cattle, meat; and grape; each with an expiration/revocation date.

The Codex has established MRLs for thiacloprid in or on various commodities, including cotton seed at 0.02 mg/kg, peppers, sweet at 1 mg/kg, and stone fruits at 0.5 mg/kg (for U.S. tolerances on cherry subgroup and peach subgroup). These MRLs are the same as the tolerances established for thiacloprid in the United States.

The Codex has established MRLs for thiacloprid, in or on various commodities, including milks at 0.05 mg/kg; pome fruits at 0.7 mg/kg, and stone fruits at 0.5 mg/kg (for U.S. tolerance on plum subgroup). These MRLs are different than the tolerances established for thiacloprid in the United States because of differences in use patterns and/or agricultural practices.

In this final rule, EPA revokes specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (e.g., a tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule 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). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), or 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.). Nor does it require any special considerations as required by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published in the Federal Register of December 17, 1997 (62 FR 66020) (FRL-5753-1), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis and available information concerning the pesticides listed in this rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket of the proposed rule.) Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

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:

I. Background

In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), in the final rule with comment period titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017” (hereafter referred to as the 2015 EHR Incentive Programs final rule with comment period) there were a number of technical errors that were identified and corrected in FR Doc. 2016-04785 of March 4, 2016 (81 FR 11447), titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting Amendment” .1 This document corrects additional technical and typographical errors that appeared in the 2015 EHR Incentive Programs final rule with comment period. The provisions in this correcting amendment are treated as if they had been included in the 2015 EHR Incentive Programs final rule with comment period.

We specified in the October 16, 2015 final rule (80 FR 62903-62905) that the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) amended section 1848(a)(7)(A) of the Social Security Act (the Act) to sunset the meaningful use payment adjustment for eligible professionals (EPs) at the end of calendar year (CY) 2018 and added section 1848(q) of the Act requiring the establishment of a Merit-based Incentive Payment System (MIPS), which would incorporate certain existing provisions and processes related to meaningful use. However, on the following pages, we made erroneous statements concerning a meaningful use payment adjustment for EPs under section 1848(a)(7)(A) of the Act in 2019:

• Page 62905, in our response to a public comment on the EHR reporting period for a payment adjustment year for EPs, we erroneously added a phrase stating that the 90-day EHR reporting period in 2017 for Stage 3 would also apply for the purposes of avoiding the payment adjustment in 2019.

• Page 62906, in TABLE 18—EHR REPORTING PERIODS AND RELATED PAYMENT ADJUSTMENT YEARS FOR EPs, we incorrectly stated that, in 2017, the EHR reporting period for a payment adjustment year for Medicaid EP returning participants demonstrating Stage 3 is any continuous 90-day period in CY 2017 and applies to avoid a payment adjustment in CY 2019 if they successfully attest by February 28, 2018.

On page 62920, in TABLE 21—BURDEN ESTIMATES STAGE 3, we inadvertently included text that was proposed but not finalized which stated that, the EP, eligible hospital or CAH incorporates into the patient's record an electronic summary of care document “from a source other than the provider's EHR system”. We are correcting this technical error to ensure that the language in the table is consistent with the language in the preamble and regulations text.

On page 62942, in paragraph (1)(ii)(C)(2) of the definition of “EHR reporting period for a payment adjustment year” at § 495.4, we incorrectly established an EHR reporting period in CY 2017 for a payment adjustment year identified as the “FY 2019 payment adjustment year.” As noted previously, the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment for EPs at the end of CY 2018. Therefore, we are amending the definition of “EHR reporting period for a payment adjustment year” by removing and reserving paragraph (1)(ii)(C)(2) to correct this error.

On page 62952, in § 495.24(d)(7)(ii)(B)(2) (Stage 3 meaningful use objectives and measures for EPs, eligible hospitals, and CAHs for 2018 and subsequent years); we inadvertently included language for the eligible hospital or CAH measure that we did not include in the EP measure. We are correcting this technical error by revising the language to ensure that the regulations text for the eligible hospital or CAH measure is consistent with the regulations text for the EP measure.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

We believe that this correcting amendment does not constitute a rulemaking that would be subject to these requirements. This correcting amendment corrects technical and typographic errors in the preamble and regulation text included in the 2015 EHR Incentive Programs final rule with comment period. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies that were adopted subject to notice and comment procedures in the final rule with comment period. As a result, the corrections made through this correcting amendment are intended to ensure that the 2015 EHR Incentive Programs final rule with comment period accurately reflects the policies adopted in that rule. In addition, even if this were a rulemaking to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule with comment period or delaying the effective date would be contrary to the public interest because it is in the public's interest for EPs, eligible hospitals, and critical access hospitals to be advised, in a timely manner, of the meaningful use criteria and EHR reporting periods that they must meet in order to qualify for Medicare and Medicaid electronic health record incentive payments and avoid payment reductions under Medicare, and to ensure that the final rule with comment period accurately reflects our policies as of the date they take effect and are applicable. Furthermore, such procedures would be unnecessary due to the changes in the law made by the MACRA, under which the meaningful use payment adjustment for EPs under section 1848(a)(7)(A) of the Act will sunset at the end of CY 2018. The statements identified above in the preamble and the regulations text concerning a payment adjustment in 2019 are moot as a result of those changes in the law. In addition, such procedures would be unnecessary, as we are not altering our policies; rather, we are simply implementing correctly the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the 2015 EHR Incentive Programs final rule with comment period accurately reflects these policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), we are making the following corrections:

1. On page 62905, first column, first partial paragraph, lines 7 through 10, the phrase “the payment adjustment in 2019 for returning participants and for the payment adjustment in 2018 for new participants” is corrected to read “the payment adjustment in 2018 for new participants”.

2. On page 62906, in TABLE 18—EHR REPORTING PERIODS AND RELATED PAYMENT ADJUSTMENT YEARS FOR EPs, the entry for 2017 is corrected to read as follows:

3. On page 62920, TABLE 21 —BURDEN ESTIMATES STAGE 3, third column, third full paragraph (Measure 2), lines 8 and 10, the phrase “an electronic summary of care document from a source other than the provider's EHR system.” is corrected to read “an electronic summary of care document.”.

As noted in section II.B. of this correcting amendment, the Centers for Medicare & Medicaid Services is making the following correcting amendments to 42 CFR part 495:

I. Background

In FR Doc. 2015-28005 (80 FR 70886 through 71386), the final rule entitled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016” (hereinafter referred to as the CY 2016 PFS final rule with comment period), there were a number of technical and typographical errors that are identified and corrected in section IV., the Correction of Errors. These corrections are applicable as of January 1, 2016.

On page 71138, due to typographical errors, the QualityNet Help Desk email address, the qualified clinical data registry (QCDR) data validation execution report delivery date, and the email subject are incorrect.

On page 71139, due to typographical errors, the QualityNet Help Desk email address, the qualified registry data validation execution report delivery date, and the email subject are incorrect.

On pages 71141 and 71145, we incorrectly stated the Measure Application Validation (MAV) process utilized to determine the reporting of Physician Quality Reporting System (PQRS) cross-cutting resources.

On page 71147, we inadvertently omitted language restating the Consumer Assessment of Healthcare Providers and Systems (CAHPS) requirements that apply to groups of 100 or more eligible professionals (EPs) that register to participate in the Group Practice Reporting Option (GPRO) regardless of reporting mechanism.

On pages 71148 through 71150, we inadvertently omitted language restating the CAHPS requirement for the QCDR reporting option in Table 28—Summary of Requirements for the 2018 PQRS Payment Adjustment: Group Practice Reporting Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO.

On page 71380 of the CY 2016 PFS final rule with comment period, we inadvertently omitted language in § 414.90(k)(5)(i). In this paragraph, we inadvertently omitted language restating the CAHPS requirements that apply to groups of 100 or more EPs that register to participate in the Group Practice Reporting Option (GPRO) regardless of reporting mechanism.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the APA notice and comment, and delay in effective date requirements; similarly, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and comment, and delay in effective date requirements of the Act. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal notice and comment rulemaking procedures for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest; and includes a statement of the finding and the reasons for it in the notice. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and the agency includes in the rule a statement of the finding and the reasons for it.

In our view, this correcting document does not constitute a rulemaking that would be subject to these requirements. This document merely corrects typographical and technical errors in the CY 2016 PFS final rule with comment period. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies and payment methodologies that were adopted subject to notice and comment procedures in the CY 2016 PFS final rule with comment period. As a result, the corrections made through this correcting document are intended to ensure that the CY 2016 PFS final rule with comment period accurately reflects the policies adopted in that rule.

Even if this were a rulemaking to which the notice and comment and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the CY 2016 PFS final rule with comment period or delaying the effective date of the corrections would be contrary to the public interest because it is in the public interest to ensure that the CY 2016 PFS final rule with comment period accurately reflects our final policies as soon as possible following the date they take effect. Further, such procedures would be unnecessary, because we are not altering the payment methodologies or policies, but rather, we are simply correcting the Federal Register document to reflect the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the CY 2016 PFS final rule with comment period accurately reflects these policies. For these reasons, we believe there is good cause to waive the requirements for notice and comment and delay in effective date.

In FR Doc. 2015-28005 of November 16, 2015 (80 FR 70886), make the following corrections:

1. On page 71138, second column, second paragraph, lines 8 through 12, the phrase and sentence “Desk at [email protected] by 5:00 p.m. e.s.t. on June 30, 2016. The email subject should be “PY2015 Qualified Registry Data Validation Execution Report.” ” are corrected to read “Desk at [email protected] by 5:00 p.m. e.s.t. on June 30, 2017. The email subject should be “PY2016 Qualified Registry Data Validation Execution Report.” ”.

2. On page 71139, third column, fifth full paragraph, lines 8 through 14, the phrase and sentence “Desk at [email protected] by 5:00 p.m. ET on June 30 of the year in which the reporting period occurs (that is, June 30, 2016 for reporting periods occurring in 2016). The email subject should be “PY2015 Qualified Registry Data Validation Execution Report.” ” are corrected to read “Desk at Qnetsupport@hcqis.org by 5:00 p.m. ET on June 30 following the year in which the reporting period occurs (that is, June 30, 2017 for the reporting periods occurring in 2016). The email subject should be “PY2016 Qualified Registry Data Validation Execution Report.” ”.

3. On page 71141, first column, first partial paragraph, lines 5 through 9, the sentence “In addition, the MAV process will also allow us to determine whether an EP should have reported on any of the PQRS cross-cutting measures.” is corrected to read “Please note, the MAV process is not utilized to determine whether an EP should have reported on any of the PQRS cross-cutting measures. This analysis occurs prior to the EP being subject to MAV.”.

4. On page 71145, third column, first partial paragraph, lines 4 through 8, the sentence “However, please note that the MAV process for the 2018 PQRS payment adjustment will now allow us to determine whether a group practice should have reported on at least 1 cross-cutting measure.” is corrected to read “Please note, the MAV process is not utilized to determine whether an EP should have reported on any of the PQRS cross-cutting measures. This analysis occurs prior to the EP being subject to MAV.”.

5. On page 71147, the third column is corrected by adding the following paragraph after the first partial paragraph:

6. On page 71148 through 71150, Table 28—Summary of Requirements for the 2018 PQRS Payment Adjustment: Group Practice Reporting Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO is corrected to read as follows:

Accordingly, 42 CFR chapter IV is corrected by making the following correcting amendments to part 414:

Background

NTIA authorizes the U.S. Government's use of radio frequency spectrum. 47 U.S.C. 902(b)(2)(A). As part of this authority, NTIA developed the NTIA Manual to provide further guidance to applicable federal agencies on the use of the radio frequency spectrum for radio transmissions for telecommunications or for other purposes. The NTIA Manual is the compilation of policies and procedures that govern the use of the radio frequency spectrum by the U.S. Government. Federal government agencies are required to follow these policies and procedures in their use of spectrum.

Part 300 of title 47 of the Code of Federal Regulations provides information about the process by which NTIA regularly revises the NTIA Manual and makes public this document and all revisions. Federal agencies are required to comply with the specifications in the NTIA Manual when requesting frequency assignments. See 47 U.S.C. 901 et seq., Executive Order 12046 (March 27, 1978), 43 FR 13349, 3 CFR 1978 Comp. at 158.

This rule updates § 300.1(b) of title 47 of the Code of Federal Regulations to specify the edition of the NTIA Manual with which federal agencies must comply when requesting frequency assignments. In particular, this rule amends § 300.1(b) by replacing “2013 Edition of the NTIA Manual, dated May 2014” with “2013 Edition of the NTIA Manual, as revised through September 2015.” See Revision to the Manual of Regulations and Procedures for Federal Radio Frequency Management, 79 FR 73486, 73486-87 (Dec. 11, 2014). (revising the Manual through May 2014). Upon the effective date of this rule, federal agencies must comply with the requirements set forth in the 2013 edition of the NTIA Manual, as revised through September 2015.

The NTIA Manual is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, by referring to Catalog Number 903-008-00000-8. A reference copy of the NTIA Manual, including all revisions in effect, is available in the Office of Spectrum Management, 1401 Constitution Avenue NW., Room 1087, Washington, DC 20230, by calling William Mitchell on (202) 482-8124, and available online at https://www.ntia.doc.gov/osmhome/redbook/redbook.html.

This rule also amends the regulatory text in section 300.1(b) of title 47 of the Code of Federal Regulations to comply with the Incorporation by Reference formatting structure.

This action does not contain collection of information requirements subject to the Paperwork Reduction Act (PRA). Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the Paperwork Reduction Act unless that collection displays a currently valid OMB Control Number.

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

NTIA finds good cause under 5 U.S.C. 553(b)(3)(B) to waive prior notice and opportunity for public comment as it is unnecessary. This action amends the regulations to include the date of the most current edition of the NTIA Manual. These changes do not impact the rights or obligations to the public. The NTIA Manual applies only to federal agencies. Because these changes impact only federal agencies, NTIA finds it unnecessary to provide for the notice and comment requirements of 5 U.S.C. 553. NTIA finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness for the reasons provided above. Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

The NTIA Manual provides for policies and procedures for federal agencies' use of spectrum. The NTIA Manual and the changes thereto do not substantially affect the rights or obligations of the public. As a result, this notice is not a “rule” as defined by the Congressional Review Act, 5 U.S.C. 804(3)(C).

This rule does not contain policies having federalism implications as that term is defined in Executive Order 13132.

For the reasons set forth in the preamble, NTIA amends 47 CFR part 300 as follows:

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

The 2016 Kamchatka flounder ITAC in the BSAI is 4,250 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016). In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2016 Kamchatka flounder ITAC in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,000 mt, and is setting aside the remaining 2,250 mt as incidental catch. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Kamchatka flounder in the BSAI.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Kamchatka flounder to directed fishing in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of May 24, 2016.

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

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