I. Background

Beginning July 21, 2011, the transfer date established by section 311 of the Dodd-Frank Act, 1 the powers, duties and functions of the former Office of Thrift Supervision (OTS) were divided among the FDIC for State savings associations and the Office of the Comptroller of the Currency (OCC) for Federal savings associations, and the Board of Governors of the Federal Reserve System (FRB) for savings and loan holding companies. Section 316(b) of the Dodd-Frank Act provides the manner of treatment of all orders, resolutions, determinations, regulations, and advisory materials that had been issued, made, prescribed, or allowed to become effective by the OTS. 2 The section provides that if such regulatory issuances were in effect on the day before the transfer date, they continue in effect and are enforceable by or against the appropriate successor agency until they are modified, terminated, set aside, or superseded in accordance with applicable law by such successor agency, by any court of competent jurisdiction, or by operation of law.

The Dodd-Frank Act directed the FDIC and the OCC to consult with one another and to publish a list of continued OTS regulations to be enforced by each respective agency that would continue to remain in effect until the appropriate Federal banking agency modified or removed the regulations in accordance with the applicable laws. The list was published by the FDIC and OCC as a Joint Rule in the Federal Register on July 6, 2011, 3 and shortly thereafter, the FDIC published its transferred OTS regulations as new FDIC regulations in 12 CFR parts 390 and 391. 4 When it republished the transferred OTS regulations, the FDIC noted that its staff would evaluate the transferred OTS regulations and might later recommend incorporating the transferred OTS rules into other FDIC rules, amending them or rescinding them, as appropriate.

Further, section 312(c) of the Dodd-Frank Act amended the definition of “appropriate Federal banking agency” contained in section 3(q) of the Federal Deposit Insurance Act (FDI Act)  5 to add State savings associations to the list of entities for which the FDIC is designated the “appropriate Federal banking agency.” As a result, when the FDIC acts as the “appropriate Federal banking agency” for State savings associations, as it does today, it has the authority to issue, modify, and rescind regulations involving such associations as well as for State nonmember banks and insured U.S. branches of foreign banks. 6

Finally, the Dodd-Frank Act amended the Secure and Fair Enforcement for Mortgage Licensing Act of 2008 (S.A.F.E. Act), 7 transferring the mortgage loan originator registration authority of the FDIC and certain other Federal agencies (the S.A.F.E. Act Agencies) to the Bureau. 8 On December 10, 2011, the Bureau published its Regulation G  9 which substantially duplicated the FDIC's S.A.F.E. Act regulation at part 365, subpart B of the FDIC's regulations.

On February 5, 2019, the FDIC published an NPR regarding the removal of part 390, subpart P (formerly OTS part 560), which addressed lending and investments by State savings associations. 10 The former OTS rule was transferred to the FDIC with only nominal changes. The NPR proposed removing part 390, subpart P from the Code of Federal Regulations (CFR) because, after careful review and consideration, the FDIC believed it was largely unnecessary, redundant, or duplicative of existing FDIC regulations. 11

In the NPR, the FDIC also proposed to further effectuate the transfer of supervisory authority for State savings associations from the former OTS to the FDIC by amending certain parts of part 365 of the FDIC's regulations to clarify that part 365, subpart A applies to all insured depository institutions, including State savings associations, for which the FDIC is the appropriate Federal banking agency. 12

Finally, the FDIC proposed to rescind subpart B of part 365, which relates to registration requirements for residential mortgage loan originators, due to the Bureau's issuance of its  13 regulation, Regulation G, pursuant to the Bureau's authority under the Dodd-Frank Act. In light of the Bureau's action, the FDIC considered the provisions contained in part 365, subpart B to be unnecessary, redundant, or otherwise duplicative of the Bureau regulation governing this area. 14

The FDIC issued the NPR with a 60-day comment period, which closed on April 8, 2019. The FDIC received no comments on the NPR, and consequently the final rule is adopted without change.

As discussed in the NPR, 12 CFR part 390, subpart P is being rescinded in its entirety because other existing FDIC regulations concerning permissible activities, safety and soundness standards, and real estate lending standards replicate the current requirements of part 390, subpart P.

To clarify that part 365 applies to all institutions for which the FDIC is the appropriate Federal banking agency, the FDIC is amending sections 365.1 and 365.2 of part 365 to replace the phrases “insured state nonmember banks (including state-licensed insured branches of foreign banks)” and “state nonmember bank” throughout subpart A with the phrase “FDIC-supervised institution.” In addition, section 365.1 is being revised to add the definition of the term “FDIC-supervised institution” to mean any insured depository institution for which the FDIC is the appropriate Federal banking agency pursuant to section 3(q) of the FDI Act. 15

Finally, because the Dodd-Frank Act amended the S.A.F.E. Act, transferring Federal registration requirements for mortgage loan originators from the S.A.F.E. Act Agencies (including the FDIC) to the Bureau, and the Bureau has finalized its Regulation G, the FDIC is rescinding part 365, subpart B, in its entirety, because it is outdated and no longer necessary.

In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), 16 the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.

The final rule rescinds and removes from FDIC regulations part 390, subpart P. With regard to part 365, subpart A, the final rule amends sections 365.1 and 365.2 to clarify that State savings associations as well as State nonmember banks and foreign banks having insured branches are all subject to part 365. It also rescinds and removes from the FDIC's regulations part 365, subpart B. The final rule will not create any new or revise any existing collections of information under the PRA. Therefore, no information collection request has been submitted to the OMB for review.

The Regulatory Flexibility Act (RFA), requires that, in connection with a final rule, an agency prepare a final regulatory flexibility analysis that describes the impact of the proposed rule on small entities. 17 However, a regulatory flexibility analysis is not required if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities, and publishes its certification and a short explanatory statement in the Federal Register together with the rule. The Small Business Administration (SBA) has defined “small entities” to include banking organizations with total assets of less than or equal to $550 million. 18 For the reasons provided below, the FDIC certifies that the rule would not have a significant economic impact on a substantial number of small banking organizations. Accordingly, a regulatory flexibility analysis is not required.

As of December 31, 2018, the FDIC supervised 3,489 insured financial institutions, of which 2,674 are considered small banking organizations for the purposes of the RFA. The rule primarily affects regulations that govern State savings associations. There are 36 State savings associations considered to be small banking organizations for the purposes of the RFA. 19

As explained previously, the rule would remove sections 390.260, 390.261, 390.262, 390.263, 390.264, 390.265, 390.266, 390.267, 390.268, 390.269, 390.270, 390.271, and 390.272 of part 390, subpart P because these sections are unnecessary, redundant of, or otherwise duplicative of other FDIC regulations for safety and soundness standards. Because these regulations are redundant to existing regulations, rescinding them would not have any substantive effects on small FDIC-supervised institutions.

As explained previously, part 364 covers State savings associations in section 364.101 and in appendix A. Because the lending documentation practices and standards in part 364, appendix A are substantively similar to existing regulations for State savings associations found in section 390.271, rescinding section 390.271 and the rest of part 390, subpart P would not have any substantive effects on small FDIC-supervised institutions.

As stated previously, the rule would amend part 365, subpart A so that it would expressly apply to State savings associations. Because the real estate lending requirements in sections 365.1 and 365.2 and part 364, appendix A are substantively identical to currently applicable regulations for State savings associations found in 390.264 and 390.265 (including the appendix to section 390.265), amending part 365, subpart A so that it would apply to all FDIC-supervised institutions would not have any substantive effects on small FDIC-supervised institutions.

As explained previously, the rule would rescind part 365, subpart B because the authority to implement Federal registration requirements for mortgage loan originators has been transferred by statute to the Bureau. Because rulemaking authority for the S.A.F.E. Act was transferred to the Bureau in December 2011, the removal of the FDIC's S.A.F.E. Act regulations would not have any substantive effects on small FDIC-supervised covered institutions.

Based on the information above, the FDIC certifies that the final rule would not have a significant economic impact on a substantial number of small entities.

The OMB has determined that the Final Rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA). 20 As required by SBREFA, the FDIC will submit the Final Rule and other appropriate reports to Congress and the Government Accountability Office for review.

Section 722 of the Gramm-Leach-Bliley Act  21 requires each Federal banking agency to use plain language in all of its proposed and final rules published after January 1, 2000. In the NPR, the FDIC invited comments on whether the NPR was clearly stated and effectively organized, and how the FDIC might make it easier to understand. No comments on this issue were received. Although the FDIC did not receive any comments, the FDIC sought to present the Final Rule in a simple and straightforward manner.

Under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (EGRPRA), 22 the FDIC is required to review all of its regulations at least once every 10 years in order to identify any outdated or otherwise unnecessary regulations imposed on insured institutions. 23 The FDIC, along with the other Federal banking agencies, submitted a Joint Report to Congress on March 21, 2017 (EGRPRA Report), discussing how the review was conducted, what has been done to date to address regulatory burden, and further measures the agency will take to address issues that were identified. As noted in the EGRPRA Report, the FDIC is continuing to streamline and clarify its regulations through the OTS rule integration process. By removing outdated or unnecessary regulations, such as part 390, subpart P, and modifying part 365, this rule complements other actions the FDIC has taken, separately and with the other Federal banking agencies, to further the EGRPRA mandate.

The Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA) requires that each Federal banking agency, in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions, consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations. In addition, new regulations and amendments to regulations that impose additional reporting, disclosures, or other new requirements on insured depository institutions generally must take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form. 24 The FDIC has determined that the final rule would not impose additional reporting, disclosure, or other requirements; therefore, the requirements of the RCDRIA do not apply.

For the reasons stated in the preamble, the Federal Deposit Insurance Corporation amends 12 CFR parts 365 and 390 as follows:

The substance of these special conditions previously has been published in the Federal Register for public comment. These special conditions have been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and finds that, for the same reason, good cause exists for adopting these special conditions upon publication in the Federal Register .

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

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

On June 14, 2016, Dassault applied for a change to Type Certificate No. A59NM for installation of large, non-structural glass panels in the passenger compartment in Model Falcon 7X airplanes. The Model Falcon 7X airplane has three turbofan engines. The airplane will have a maximum takeoff weight of 73,000 lbs, capacity for 2 crewmembers, and seating for 19 passengers.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Dassault must show that the Model Falcon 7X airplane, as changed, continues to meet the applicable provisions of the regulations listed in type certificate no. A59NM, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Dassault Model Falcon 7X airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Dassault Model Falcon 7X airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise- certification requirements of 14 CFR part 36.

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

The Dassault Model Falcon 7X airplane will have a novel or unusual design feature associated with the installation of large, non-structural glass panels in the cabin area occupied by passengers and crew. Possible installations of large, non-structural glass items include, but are not limited to, the following items:

• Glass partitions.

• Glass floor installations.

• Glass attached to the ceiling.

• Glass parts integrated in a stairway.

• Wall- or door-mounted mirrors and glass panels.

• Mirrors as part of a door blow-out panel.

• Glass plate installed in a doorframe.

• Washstand with glass panel.

The installation of these glass items in the passenger compartment, which can be occupied during taxi, takeoff, and landing (TT&L), is a novel or unusual design feature with respect to the installed material. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature.

The use of glass results in trade-offs between the one unique characteristic of glass—its capability for undistorted or controlled light transmittance, or transparency—and the negative aspects of the material. Glass, in its basic form as annealed, untreated sheet, plate, or float glass, when compared to metals, is extremely notch-sensitive, has a low fracture resistance, has a low modulus of elasticity, and can be highly variable in its properties. While reasonably strong, it is nonetheless not a desirable material for traditional airplane applications because it is heavy (about the same density as aluminum), and when it fails, it breaks into extremely sharp fragments that have the potential for injury, and which have been known to be lethal. Thus, the use of glass traditionally was limited to windshields, and instrument or display transparencies. The regulations in § 25.775 only address, and likewise only recognize, the unique use of glass in windshield or window applications where no other material will serve. This regulation does address the adverse properties of glass, but pilots occasionally are injured from shattered glass windshields.

The FAA divides other uses of glass in the passenger cabin into four groups. These groups were created to address the practical and functional uses of glass. The four groups are as follows:

The first group is glass items installed in rooms or areas in the cabin that are not occupied during TT&L, and a person does not have to enter or pass through the room or area to get to any emergency exit.

The second group is glass integrated into a functional device the operation of which is dependent upon the characteristics of glass, such as instrument or indicator protective transparencies, or monitor screens such as liquid crystal displays or plasma displays. This group may be installed in any area in the cabin regardless of occupancy during TT&L. Acceptable means of compliance for these items may depend on the size and specific location of the device containing the glass.

The third group is small glass items installed in occupied rooms or areas during TT&L, or rooms or areas that a person does not have to enter or pass through to get to any emergency exit. The FAA defines a small glass item as less than 8.8 lbs (4 kg) in mass.

The fourth group is large glass items, the subject of these special conditions, installed in occupied rooms or areas during TT&L, or rooms or areas that a person must enter or pass through to get to any emergency exit. A large glass item is defined as 8.8 lbs (4 kg) or greater in mass. Groups of glass items that collectively weigh 4 kg or more would also be included. The mass is based on the amount of glass that becomes hazardous in high inertial loads.

The glass items in groups one, two, and three are restricted to applications where the potential for injury is either highly localized, such as flight-instrument faces, or the location is such that injury due to failure of the glass is unlikely, for example mirrors in lavatories, because these installations necessitate the use of glass. These glass items typically are addressed in a method-of-compliance issue paper for each project based on existing part 25 regulations, or in established policy. These issue papers identify specific tests that could include abuse loading and ball-impact testing. In addition, these items are subject to the inertia loads contained in § 25.561, and maximum positive-differential pressure for items like video monitors to meet § 25.789.

The items in group four are much larger and heavier than previously approved, and raise additional safety concerns. These large, heavy glass panels, primarily installed as architectural features, were not envisioned in the regulations. The unique aspects of glass, with the potential to become highly injurious or lethal objects during emergency landing, minor crash conditions, or in flight, warrant a unique approach to certification that addresses the characteristics of glass that prevented its use in the past. These special conditions were developed to ensure that airplanes with large glass features in passenger cabins provide the same level of safety as airplanes using traditional, lightweight materials. The FAA reiterates this intention in the text of the special conditions by qualifying their use for group four glass items.

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

As discussed above, these special conditions are applicable to Dassault Model Falcon 7X airplanes. Should Dassault apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

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

The authority citation for these special conditions is as follows:

For large glass items (a single item, or a collective group of glass items, that weigh 4 kg or more in mass) installed in passenger-occupied rooms or areas during taxi, takeoff, and landing, or installed in rooms or areas that occupants must enter or pass through to access any emergency exit, the glass installations on the Dassault Model Falcon 7X airplane must meet the following conditions:

1. Material Fragmentation —The applicant must use tempered or otherwise treated glass to ensure that, when fractured, the glass breaks into small pieces with relatively dull edges. The glass component installation must retain glass fragments to minimize the danger from flying glass shards or pieces. The applicant must demonstrate this characteristic by impact and puncture testing, and testing to failure. The applicant may conduct this test with or without any glass coating that may be utilized in the design.

2. Strength —In addition to meeting the load requirements for all flight and landing loads, including any of the applicable emergency-landing conditions in subparts C & D of 14 CFR part 25, the glass components that are located such that they are not protected from contact with cabin occupants must not fail due to abusive loading, such as impact from occupants stumbling into, leaning against, sitting on, or performing other intentional or unintentional forceful contact with the glass component. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

3. Retention —The glass component, as installed in the airplane, must not come free of its restraint or mounting system in the event of an emergency landing, considering both the directional loading and resulting rebound conditions. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

4. Instructions for Continued Airworthiness —The instructions for continued airworthiness must reflect the method used to fasten the panel to the cabin interior and must ensure the reliability of the methods used ( e.g., life limit of adhesives, or clamp connection). The applicant must define any inspection methods and intervals based upon adhesion data from the manufacturer of the adhesive, or upon actual adhesion-test data, if necessary.

The substance of these special conditions previously has been published in the Federal Register for public comment. These special conditions have been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and finds that, for the same reason, good cause exists for adopting these special conditions upon publication in the Federal Register .

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

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

On June 14, 2016, Dassault applied for a change to Type Certificate No. A46EU for installation of large, non-structural glass panels in the passenger compartment in Model Falcon 900EX airplane. The Model Falcon 900EX airplane has three turbofan engines. The airplane will have a maximum takeoff weight of 43,800 lbs, capacity for 2 crewmembers, and seating for 19 passengers.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Dassault must show that the Model Falcon 900EX airplane, as changed, continues to meet the applicable provisions of the regulations listed in type certificate no. A46EU, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Dassault Model Falcon 900EX airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Dassault Model Falcon 900EX airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

The Dassault Model Falcon 900EX airplane will have a novel or unusual design feature associated with the installation of large, non-structural glass panels in the cabin area occupied by passengers and crew. Possible installations of large, non-structural glass items include, but are not limited to, the following items:

• Glass partitions.

• Glass floor installations.

• Glass attached to the ceiling.

• Glass parts integrated in a stairway.

• Wall- or door-mounted mirrors and glass panels.

• Mirrors as part of a door blow-out panel.

• Glass plate installed in a doorframe.

• Washstand with glass panel.

The installation of these glass items in the passenger compartment, which can be occupied during taxi, takeoff, and landing (TT&L), is a novel or unusual design feature with respect to the installed material. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature.

The use of glass results in trade-offs between the one unique characteristic of glass—its capability for undistorted or controlled light transmittance, or transparency—and the negative aspects of the material. Glass, in its basic form as annealed, untreated sheet, plate, or float glass, when compared to metals, is extremely notch-sensitive, has a low fracture resistance, has a low modulus of elasticity, and can be highly variable in its properties. While reasonably strong, it is nonetheless not a desirable material for traditional airplane applications because it is heavy (about the same density as aluminum), and when it fails, it breaks into extremely sharp fragments that have the potential for injury, and which have been known to be lethal. Thus, the use of glass traditionally was limited to windshields, and instrument or display transparencies. The regulations in § 25.775 only address, and likewise only recognize, the unique use of glass in windshield or window applications where no other material will serve. This regulation does address the adverse properties of glass, but pilots occasionally are injured from shattered glass windshields.

The FAA divides other uses of glass in the passenger cabin into four groups. These groups were created to address the practical and functional uses of glass. The four groups are as follows:

The first group is glass items installed in rooms or areas in the cabin that are not occupied during TT&L, and a person does not have to enter or pass through the room or area to get to any emergency exit.

The second group is glass integrated into a functional device the operation of which is dependent upon the characteristics of glass, such as instrument or indicator protective transparencies, or monitor screens such as liquid crystal displays or plasma displays. This group may be installed in any area in the cabin regardless of occupancy during TT&L. Acceptable means of compliance for these items may depend on the size and specific location of the device containing the glass.

The third group is small glass items installed in occupied rooms or areas during TT&L, or rooms or areas that a person does not have to enter or pass through to get to any emergency exit. The FAA defines a small glass item as less than 8.8 lbs (4 kg) in mass.

The fourth group is large glass items, the subject of these special conditions, installed in occupied rooms or areas during TT&L, or rooms or areas that a person must enter or pass through to get to any emergency exit. A large glass item is defined as 8.8 lbs (4 kg) or greater in mass. Groups of glass items that collectively weigh 4 kg or more would also be included. The mass is based on the amount of glass that becomes hazardous in high inertial loads.

The glass items in groups one, two, and three are restricted to applications where the potential for injury is either highly localized, such as flight-instrument faces, or the location is such that injury due to failure of the glass is unlikely, for example mirrors in lavatories, because these installations necessitate the use of glass. These glass items typically are addressed in a method-of-compliance issue paper for each project based on existing part 25 regulations, or in established policy. These issue papers identify specific tests that could include abuse loading and ball-impact testing. In addition, these items are subject to the inertia loads contained in § 25.561, and maximum positive-differential pressure for items like video monitors to meet § 25.789.

The items in group four are much larger and heavier than previously approved, and raise additional safety concerns. These large, heavy glass panels, primarily installed as architectural features, were not envisioned in the regulations. The unique aspects of glass, with the potential to become highly injurious or lethal objects during emergency landing, minor crash conditions, or in flight, warrant a unique approach to certification that addresses the characteristics of glass that prevented its use in the past. These special conditions were developed to ensure that airplanes with large glass features in passenger cabins provide the same level of safety as airplanes using traditional, lightweight materials. The FAA reiterates this intention in the text of the special conditions by qualifying their use for group four glass items.

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

As discussed above, these special conditions are applicable to Dassault Model Falcon 900EX airplanes. Should Dassault apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

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

The authority citation for these special conditions is as follows:

For large glass items (a single item, or a collective group of glass items, that weigh 4 kg or more in mass) installed in passenger-occupied rooms or areas during taxi, takeoff, and landing, or installed in rooms or areas that occupants must enter or pass through to access any emergency exit, the glass installations on the Dassault Model Falcon 900EX airplane must meet the following conditions:

1. Material Fragmentation —The applicant must use tempered or otherwise treated glass to ensure that, when fractured, the glass breaks into small pieces with relatively dull edges. The glass component installation must retain glass fragments to minimize the danger from flying glass shards or pieces. The applicant must demonstrate this characteristic by impact and puncture testing, and testing to failure. The applicant may conduct this test with or without any glass coating that may be utilized in the design.

2. Strength —In addition to meeting the load requirements for all flight and landing loads, including any of the applicable emergency-landing conditions in subparts C & D of 14 CFR part 25, the glass components that are located such that they are not protected from contact with cabin occupants must not fail due to abusive loading, such as impact from occupants stumbling into, leaning against, sitting on, or performing other intentional or unintentional forceful contact with the glass component. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

3. Retention —The glass component, as installed in the airplane, must not come free of its restraint or mounting system in the event of an emergency landing, considering both the directional loading and resulting rebound conditions. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

4. Instructions for Continued Airworthiness —The instructions for continued airworthiness must reflect the method used to fasten the panel to the cabin interior and must ensure the reliability of the methods used ( e.g., life limit of adhesives, or clamp connection). The applicant must define any inspection methods and intervals based upon adhesion data from the manufacturer of the adhesive, or upon actual adhesion-test data, if necessary.

The substance of these special conditions previously has been published in the Federal Register for public comment. These special conditions have been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and finds that, for the same reason, good cause exists for adopting these special conditions upon publication in the Federal Register .

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

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

On June 14, 2016, Dassault applied for a change to Type Certificate No. A50NM for installation of large, non-structural glass panels in the passenger compartment in Model Falcon 2000EX airplane. The Model Falcon 2000EX airplane has three turbofan engines. The airplane will have a maximum takeoff weight of 42,800 lbs, capacity for 2 crewmembers, and seating for 19 passengers.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Dassault must show that the Model Falcon 2000EX airplane, as changed, continues to meet the applicable provisions of the regulations listed in type certificate no. A50NM, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Dassault Model Falcon 2000EX airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Dassault Model Falcon 2000EX airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

The Dassault Model Falcon 2000EX airplane will have a novel or unusual design feature associated with the installation of large, non-structural glass panels in the cabin area occupied by passengers and crew. Possible installations of large, non-structural glass items include, but are not limited to, the following items:

• Glass partitions.

• Glass floor installations.

• Glass attached to the ceiling.

• Glass parts integrated in a stairway.

• Wall- or door-mounted mirrors and glass panels.

• Mirrors as part of a door blow-out panel.

• Glass plate installed in a doorframe.

• Washstand with glass panel.

The installation of these glass items in the passenger compartment, which can be occupied during taxi, takeoff, and landing (TT&L), is a novel or unusual design feature with respect to the installed material. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature.

The use of glass results in trade-offs between the one unique characteristic of glass—its capability for undistorted or controlled light transmittance, or transparency—and the negative aspects of the material. Glass, in its basic form as annealed, untreated sheet, plate, or float glass, when compared to metals, is extremely notch-sensitive, has a low fracture resistance, has a low modulus of elasticity, and can be highly variable in its properties. While reasonably strong, it is nonetheless not a desirable material for traditional airplane applications because it is heavy (about the same density as aluminum), and when it fails, it breaks into extremely sharp fragments that have the potential for injury, and which have been known to be lethal. Thus, the use of glass traditionally was limited to windshields, and instrument or display transparencies. The regulations in § 25.775 only address, and likewise only recognize, the unique use of glass in windshield or window applications where no other material will serve. This regulation does address the adverse properties of glass, but pilots occasionally are injured from shattered glass windshields.

The FAA divides other uses of glass in the passenger cabin into four groups. These groups were created to address the practical and functional uses of glass. The four groups are as follows:

The first group is glass items installed in rooms or areas in the cabin that are not occupied during TT&L, and a person does not have to enter or pass through the room or area to get to any emergency exit.

The second group is glass integrated into a functional device the operation of which is dependent upon the characteristics of glass, such as instrument or indicator protective transparencies, or monitor screens such as liquid crystal displays or plasma displays. This group may be installed in any area in the cabin regardless of occupancy during TT&L. Acceptable means of compliance for these items may depend on the size and specific location of the device containing the glass.

The third group is small glass items installed in occupied rooms or areas during TT&L, or rooms or areas that a person does not have to enter or pass through to get to any emergency exit. The FAA defines a small glass item as less than 8.8 lbs (4 kg) in mass.

The fourth group is large glass items, the subject of these special conditions, installed in occupied rooms or areas during TT&L, or rooms or areas that a person must enter or pass through to get to any emergency exit. A large glass item is defined as 8.8 lbs (4 kg) or greater in mass. Groups of glass items that collectively weigh 4 kg or more would also be included. The mass is based on the amount of glass that becomes hazardous in high inertial loads.

The glass items in groups one, two, and three are restricted to applications where the potential for injury is either highly localized, such as flight-instrument faces, or the location is such that injury due to failure of the glass is unlikely, for example mirrors in lavatories, because these installations necessitate the use of glass. These glass items typically are addressed in a method-of-compliance issue paper for each project based on existing part 25 regulations, or in established policy. These issue papers identify specific tests that could include abuse loading and ball-impact testing. In addition, these items are subject to the inertia loads contained in § 25.561, and maximum positive-differential pressure for items like video monitors to meet § 25.789.

The items in group four are much larger and heavier than previously approved, and raise additional safety concerns. These large, heavy glass panels, primarily installed as architectural features, were not envisioned in the regulations. The unique aspects of glass, with the potential to become highly injurious or lethal objects during emergency landing, minor crash conditions, or in flight, warrant a unique approach to certification that addresses the characteristics of glass that prevented its use in the past. These special conditions were developed to ensure that airplanes with large glass features in passenger cabins provide the same level of safety as airplanes using traditional, lightweight materials. The FAA reiterates this intention in the text of the special conditions by qualifying their use for group four glass items.

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

As discussed above, these special conditions are applicable to Dassault Model Falcon 2000EX airplanes. Should Dassault apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

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

The authority citation for these special conditions is as follows:

For large glass items (a single item, or a collective group of glass items, that weigh 4 kg or more in mass) installed in passenger-occupied rooms or areas during taxi, takeoff, and landing, or installed in rooms or areas that occupants must enter or pass through to access any emergency exit, the glass installations on the Dassault Model Falcon 2000EX airplane must meet the following conditions:

1. Material Fragmentation —The applicant must use tempered or otherwise treated glass to ensure that, when fractured, the glass breaks into small pieces with relatively dull edges. The glass component installation must retain glass fragments to minimize the danger from flying glass shards or pieces. The applicant must demonstrate this characteristic by impact and puncture testing, and testing to failure. The applicant may conduct this test with or without any glass coating that may be utilized in the design.

2. Strength —In addition to meeting the load requirements for all flight and landing loads, including any of the applicable emergency-landing conditions in subparts C & D of 14 CFR part 25, the glass components that are located such that they are not protected from contact with cabin occupants must not fail due to abusive loading, such as impact from occupants stumbling into, leaning against, sitting on, or performing other intentional or unintentional forceful contact with the glass component. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

3. Retention —The glass component, as installed in the airplane, must not come free of its restraint or mounting system in the event of an emergency landing, considering both the directional loading and resulting rebound conditions. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

4. Instructions for Continued Airworthiness —The instructions for continued airworthiness must reflect the method used to fasten the panel to the cabin interior and must ensure the reliability of the methods used ( e.g., life limit of adhesives, or clamp connection). The applicant must define any inspection methods and intervals based upon adhesion data from the manufacturer of the adhesive, or upon actual adhesion-test data, if necessary.

I. Overview and Background

The Economic Growth, Regulatory Relief, and Consumer Protection Act (“the Act”) was signed into law on May 24, 2018. Public Law 115-174. The Act, among other things, amends section 605A of the FCRA, 15 U.S.C. 1681c-1, to add a section 605A(k). Section 605A(k)(2) requires that NCRAs provide free electronic credit monitoring services to active duty military consumers.

Section 605A(k)(3) of the FCRA requires the Commission to issue a regulation clarifying the meaning of certain terms used in section 605A(k)(2), including “electronic credit monitoring service” and “material additions or modifications to the file of a consumer.” In addition, section 605A(k)(3) requires that the Commission's regulation clarify what constitutes appropriate proof that an individual is an active duty military consumer.

On November 16, 2018 (83 FR 57693), the Commission published a notice of proposed rulemaking (“NPRM”). The proposed rule applied to NCRAs, as defined in section 603(p) of the Fair Credit Reporting Act, 15 U.S.C. 1681a(p). The proposed rule required the NCRAs to provide a free electronic credit monitoring service that notifies a consumer of material additions or modifications to the consumer's file when the consumer provides (1) contact information, (2) appropriate proof that the consumer is an active duty military consumer, and (3) appropriate proof of identity. The proposed rule specified that the NCRA must provide notification to the consumer within 24 hours of the material addition or modification. The proposed rule also required that the notifications to consumers include a hyperlink to a summary of the consumer's rights under the FCRA, as prescribed by the Bureau of Consumer Financial Protection under 15 U.S.C. 1681g(c).

The proposed rule defined certain key terms, including “electronic credit monitoring service,” “electronic notification,” and “material additions or modifications.” The proposed rule also specified what constitutes appropriate proof that the consumer is an active duty military consumer.

Further, the proposed rule restricted NCRAs' ability to use and disclose the information they collect from consumers in order to provide the required electronic credit monitoring service. Additionally, the proposed rule contained some limitations on communications surrounding enrollment in an electronic credit monitoring service. Finally, the proposed rule prohibited asking or requiring an active duty military consumer to agree to terms or conditions in connection with obtaining a free electronic credit monitoring service.

In response to the NPRM, the Commission received 19 comments from industry representatives, military and consumer advocacy groups, government agencies, members of Congress, and individual members of the public. 1 In addition to providing feedback on the proposed rule, commenters highlighted the importance of military consumers' financial health for overall military readiness and national security. These commenters noted that “servicemembers in financial distress are often forced to leave the military due to loss of security clearance or for other reasons.”  2 Commenters also noted the rule's importance in protecting military consumers from fraud. 3

Proposed § 609.1 described the statutory authority for the proposed rule, section 605A(k)(2) of the FCRA, 15 U.S.C. 1681c-1(k)(2). The Commission received no comments on this section, and adopts it as proposed.

The NPRM proposed defining “active duty military consumer” as a consumer in military service, as defined in the FCRA. Prior to enactment of the Act, section 603(q)(1) of the FCRA, 15 U.S.C. 1681a(q)(1), defined an “active duty military consumer” as a consumer in military service who—(A) is on active duty (as defined in section 101(d)(1) of title 10, United States Code) or is a reservist performing duty under a call or order to active duty under a provision of law referred to in section 101(a)(13) of title 10, United States Code; and (B) is assigned to service away from the usual duty station of the consumer. The Act added section 605A(k)(1) to the FCRA, 15 U.S.C. 1681c-1(k)(1), and specified that, in the credit monitoring subsection, the term “active duty military consumer” also includes a member of the National Guard, with the term “National Guard” having the meaning given the term in section 101(c) of title 10, United States Code. Thus, the proposed rule defined “active duty military consumer” as a “consumer in military service as defined in 15 U.S.C. 1681a(q)(1) and 1681c-1(k)(1).”  4

The Commission received several comments on this definition. DoD expressed concern that the proposed definition could result in military consumers receiving unequal access to the free credit monitoring services based on their individual military component, duty status, or location. 5 For example, DoD stated that the requirement for the consumer to be “assigned to service away from the usual duty station” is severely limiting, as a military consumer is likely to spend most of her active duty career assigned to the “usual duty station.” DoD recommended that the Commission modify the definition in order to be consistent with the definition of active duty in the military compensation statute, 6 which does not require that the military consumer be deployed away from her usual duty station. Military groups commented that the Commission should defer to DoD on this definition. 7 Senators Carper and Coons commented that the rule should cover “the largest number of servicemembers as permitted by the law.”  8 Another commenter recommended that the rule cover retired military consumers. 9

While the Commission recognizes and appreciates the policy rationale behind broadening the group of military consumers who are eligible to receive free credit monitoring, the statutory language limits the Commission's discretion on this topic. In amending the FCRA, Congress recognized that the FCRA's existing definition of “active duty military consumer” excluded members of the National Guard. Congress specified that, for purposes of the credit monitoring provisions, an “active duty military consumer,” includes a member of the National Guard. 10 The fact that the Act addressed the exclusion of the National Guard, but not the definition's requirement that the military consumer be “assigned to service away from the usual duty station,” suggests that Congress may have intended for that limitation to remain. To the extent that Congress intended to provide free credit monitoring more broadly, i.e., to all active duty military, regardless of their duty station, the Commission calls on Congress to address this issue through additional legislation. If Congress passes legislation to provide the Commission with statutory authority to promulgate a more expansive rule, the Commission will act expeditiously to do so.

The Commission acknowledges that the proposed rule's definition did not expressly address whether a National Guard member covered by the definition in 15 U.S.C. 1681c-1(k)(1) also needs to be assigned to service away from the usual duty station. The Commission recognizes that providing National Guard members with free credit monitoring at all times, while limiting the service for individuals serving in other military components, such as the Army or Air Force, to those assigned away from their usual duty station, would result in an inequitable distribution of benefits. However, when Congress amended the FCRA to add section 605A(k)(1), it did not expressly apply the duty station requirement to National Guard members. Thus, the statutory language is imprecise on this question. Therefore, notwithstanding this apparent inequity, the Commission has interpreted the Act as providing the benefit of free credit monitoring to members of the National Guard regardless of whether they are assigned away from their usual duty station. To ensure clarity on this issue, the Commission has determined to modify the definition of active duty military consumer as (1) a consumer in military service that meets the original FCRA definition of “active duty military consumer” (15 U.S.C. 1681a(q)(1)); or (2) a member of the National Guard (10 U.S.C. 101(c)).

The NPRM proposed defining “appropriate proof of identity” as having the same meaning set forth in 12 CFR 1022.123. That section requires consumer reporting agencies (“CRAs”) to develop reasonable policies for determining a consumer's identity for purposes of FCRA sections 605A (obtaining a fraud alert), 605B (requesting that information resulting from identity theft be blocked from one's consumer report), and 609(a)(1) (requesting a file disclosure from a CRA). The definition is risk-based, meaning that a CRA's policy with respect to appropriate proof of identity should be commensurate with the risk of harm to the consumer resulting from misidentification, and should not unreasonably restrict a consumer's access to statutorily required services. The NPRM specifically sought comment on whether the rule should keep this cross-reference to 12 CFR 1022.123, stay silent on the definition, or develop a different approach.

The Commission received one comment supporting the NPRM definition and two comments recommending changes. The Consumer Data Industry Association (“CDIA”) commented that referencing the existing standard would reduce the implementation burden for its NCRA members. 11 Consumer and military groups recommended that the Commission tailor “appropriate proof of identity” to the unique circumstances of military consumers. 12 These commenters noted that military consumers often move frequently, making it burdensome for them to provide the 2-year address history that CRAs currently require for identity validation for file disclosures. These commenters also stated the NCRAs require less identifying information from consumers who are purchasing their credit report than they do from consumers who are seeking access to their free annual credit report.

After carefully considering the comments received, the Commission has determined to retain the definition of “appropriate proof of identity” without modification. The existing definition requires the NCRAs to develop “reasonable requirements” that take into account the “identifiable risk of harm” that could result from misidentification. 13 The Commission interprets the existing standard's reasonableness requirement to obligate the NCRAs to consider the unique circumstances of military consumers in developing their requirements for proof of identity for the free electronic credit monitoring service. They must weigh any such considerations against the risk of harm from providing sensitive credit report information to the wrong consumer while not restricting access to the statutorily mandated services unreasonably. In response to the concern that NCRAs currently require less identifying information for paid services than for free services, the Commission notes that the fact that a consumer is requesting a free rather than a paid service should not by itself prompt a higher standard for proof of identity, unless the NCRA is using the payment method as an additional form of authentication or there are other identified aspects of the unpaid service that increase the fraud risk.

The proposed rule defined “electronic credit monitoring service” as a service through which NCRAs provide, at a minimum, electronic notification of material additions or modifications to a consumer's file. The Commission solicited comment as to whether this definition is adequate or if any modifications are necessary.

Several commenters stated that the proposed definition is not adequate and that the Commission should expand it to include free electronic access to the consumer's credit file following a notification of a material addition or modification. 14 Commenters noted that without this free access, military consumers may be required to pay to examine their credit files following the receipt of a notification. One commenter stated that the information contained in the files of the three NCRAs is not always the same and recommended that the rule provide free access to the credit files at all three NCRAs following a notification. 15 The commenters also noted that commercial credit monitoring products typically include access to credit reports.

The Commission agrees with the commenters that free access to their credit files following a notification will allow the active duty military consumer to evaluate the addition or modification in the context of their entire credit report without being required to pay for that access in connection with a service that Congress intended them to receive for free. Indeed, current commercial credit monitoring services offered by the NCRAs advertise that they provide consumers with access to their credit files. However, the Commission declines to require an NCRA to pay the costs of obtaining a consumer's credit files from the other two NCRAs for the purposes of providing the files to the consumer. Instead, consumers who are concerned about potential discrepancies in their files at the three NCRAs can request free credit monitoring services from all three of them.

Given the comments received, the Commission modifies the definition of electronic credit monitoring service as follows: A service through which NCRAs provide, at a minimum, electronic notification of material additions or modifications to a consumer's file and following a notification, access to all information in the consumer's file at the NCRA at the time of the notification, in accordance with 15 U.S.C. 1681g(a). 16

The proposed rule defined “electronic notification” as a notice provided to the consumer via a website; mobile application; email; or text message. The NPRM asked whether this definition is adequate or whether the rule should include additional methods.

The Commission received a number of comments on this definition. CDIA commented that it appreciates the flexibility the definition gives and noted that the proposed definition includes the methods of delivery currently in use in the marketplace. 17 Consumer groups raised a concern that website notifications could result in the NCRAs not actively informing military consumers of material changes, instead requiring the consumer to regularly and proactively check their account on the website. They recommended that the Commission clarify that, when a notification is made via website, there should be some form of active “push” notification, whether via email, text, or mobile app notification, of the fact that there have been material additions or modifications. 18 This would ensure a consumer is notified of changes, even if the consumer must then go to the website to determine what that actual change is. Blue Star Families recommended that the notification methods include encrypted messaging platforms such as WhatsApp or Signal, which military consumers may commonly use during training events or deployment. 19 They also recommended that military consumers be able to designate an alternate point of contact when they don't have access to notification platforms or the ability to take action based on an alert.

The Commission has carefully considered the comments received. As to the use of encrypted messaging platforms, the Commission notes that the proposed definition already allows the NCRAs to provide notices via mobile applications; thus, no change to the rule is necessary to allow them to provide notices via these platforms. As to allowing an alternate point of contact, the Commission is concerned about the security implications of requiring NCRAs to transmit sensitive alerts about consumers' credit information to multiple points of contact. Although the Commission declines to modify the proposed rule to require alternative points of contact, we understand the concerns that the military consumer may be unable to access notification platforms or take action based on alerts while deployed. Accordingly, the Commission encourages the NCRAs to explore options for addressing these issues.

Finally, as to notification via website, the Commission agrees that military consumers should not have to proactively log onto to a website in order to continually check whether a material addition or modification has been made to their files. Instead, there should be some form of active notification. Accordingly, the final rule deletes the reference to allowing notification by website. It continues to require electronic notification of material additions or modifications by mobile application, email, or text message, but clarifies that the notices can link to a website where the consumer can find additional information regarding the specifics of the addition or modification.

The proposed rule defined “free” as “provided at no cost to the consumer.” The Commission received one comment on this definition. Senators Carper and Coons recommended that the Commission define “free” to prohibit the secondary use of military consumers' personal information; the disclosure of such information to third parties; the use of such information for marketing purposes; or the implication that the consumer should purchase identity theft insurance. 20 The Commission agrees with the Senators that the rule should not allow secondary uses, disclosures to third parties, or the use of information for marketing purposes, but does not believe that a change to the definition of “free” is necessary. As discussed below, the rule already specifies that the NCRAs can use information collected to provide the military credit monitoring service only in four instances: To provide the service requested by the consumer; to process a transaction requested by the consumer at the same time he or she requests the service; to comply with applicable legal requirements; or to update information the NCRA already maintains for the purpose of providing consumer reports, with certain limitations. Thus, the rule would not permit the uses contemplated by the commenters. As to the suggestion that the definition of “free” prohibit the implication that the consumer should purchase identity theft insurance, the rule already requires NCRAs to delay all marketing until after the consumer has enrolled in the free electronic credit monitoring service. This requirement would include marketing of insurance products. Given the restrictions on information use, disclosure, and marketing in other sections of the rule, the Commission has determined to adopt the proposed rule's definition of “free” without modification.

The NPRM defined “material additions or modifications” as significant changes to a consumer's file, including the establishment of new accounts; inquiries or requests for a consumer report, other than for prescreening or account review; changes to name, address, or phone number; changes to credit account limits; and negative information. The Commission requested comment on whether this definition was adequate or if the rule should add other elements. The Commission also requested comment on specific issues related to this definition, including whether changes to credit account limits should remain; whether the exceptions for prescreening and account review are appropriate; and whether NCRAs have the ability to differentiate between inquiries made for the purposes of account review and collection.

The Commission received two comments recommending global changes to the definition of material additions or modifications. First, consumer groups recommended that the definition provide an exhaustive list of material changes and that the NCRAs be required to get Commission approval to provide notifications for any changes not on that list. 21 They expressed concern that without such a limitation, the NCRAs may over-notify military consumers and cause unnecessary alarm. Second, CDIA recommended that the list of material changes be examples and that the Commission provide a safe harbor for the NCRAs to provide their commercial credit monitoring services to active duty military consumers for free. 22 CDIA expressed concern that without a safe harbor, the rule will force the NCRAs to develop new products and services. CDIA noted that Congress chose to require only one portion of the consumer reporting market—the NCRAs—to provide their credit monitoring services to active duty military consumers for free. Therefore, CDIA stated that the Commission should seek to reduce the burdens and costs placed on the NCRAs.

The Commission does not believe it is necessary for the rule to provide an exhaustive list of material additions or modifications because the Commission believes the risk of over-notification from allowing NCRAs to notify consumers of additional changes is low. The NCRAs do not have an incentive to increase their costs by providing excessive notifications to military consumers.

The Commission also declines to grant the NCRAs a safe harbor for providing their commercial credit monitoring services to military consumers for free. The Act requires the Commission to promulgate a rule that defines “material additions or modifications to the file of a consumer.” In the absence of a minimum standard, NCRAs could create new tiers for commercial credit monitoring products and offer active duty military consumers free versions of a new product with only limited features. Congress could not have intended this result.

At the same time, the Commission appreciates that providing a free electronic credit monitoring service to active duty military consumers will place costs and burdens on the NCRAs. Thus, as discussed below, the Commission has sought to align the requirements with the NCRAs' existing commercial credit monitoring services as much as possible while ensuring that the service required by the rule provides appropriate consumer protections.

In addition to receiving global comments on the definition of “material addition or modification,” the Commission received comments on several specific proposals. First, the proposed rule's inclusion of changes to a consumer's name, address, or phone number was the subject of several comments. One commenter expressed support for including these changes. 23 Another commenter recommended that the rule also include a change to email address as a material addition or modification because the CRAs typically notify customers of their commercial credit monitoring services of changes via email. 24 On the other hand, CDIA recommended that the Commission remove changes to consumers' names, addresses and phone numbers from the definition because those changes are not uniformly part of the NCRAs' commercial credit monitoring products. 25

After considering these comments, the Commission has decided to retain the requirement to notify consumers of changes to their address. The Commission is concerned that failing to provide a notification about the appearance of a new address in a consumer's file will potentially leave consumers without notice of a key indicator of fraud. For example, an identity thief may change the address listed on a consumer's existing credit card account in order to reroute statements so that the consumer does not see fraudulent charges. At least one of the NCRAs currently provides alerts for address changes. 26 Additionally, it appears that new addresses are monitored in all three of the NCRAs' consumer files. 27 Furthermore, in other sections of the FCRA, Congress has put in place requirements that suggest it believed that a change in address could be a sign of fraud. 28 To lessen the chance of over-notification, the Commission has decided to modify the requirement to clarify that only a material change to an address requires notification. Thus, if the address 123 Main Street was already included in a consumer's file, the NCRAs are not required to provide a notification if a creditor reports an address of 123 Main St. 29

However, the Commission has decided to remove the requirement that the NCRAs provide notifications for changes to name and phone number. Unlike addresses, it is not clear whether changes to the names and phone numbers in consumers' files are routinely monitored or included in commercial credit monitoring alerts. For similar reasons, the Commission declines to require notifications for changes to email address. Of course, nothing in the rule prohibits the NCRAs from providing such alerts if they choose to do so.

Second, several commenters addressed the definition's inclusion of changes to credit account limits. Some commenters recommended retaining notification for changes to credit account limits, noting that this information is useful to military consumers. 30 CDIA recommended removing changes to credit account limits because NCRAs do not uniformly include notification of changes to account limits in commercial credit monitoring services, such changes are not indicative of identity theft or fraud, and the proposed rule gives no guidance on what level of change in account limits would be material. 31

The Commission has decided to retain the category of “changes to credit account limits” in the list of material additions and modifications of which consumers must be notified. The Commission disagrees with the comment that changes to credit account limits are not indicative of identity theft or fraud. For example, an identity thief may call a credit card company and request that an account limit be raised so that she can make additional fraudulent charges. Indeed, in drafting the FCRA provision dealing with fraud alerts, Congress prohibited creditors from increasing the credit limit on an existing account that contains a fraud alert without verifying the requestor's identity. This prohibition illustrates that Congress believed that such a change in account limits could be indicative of fraud. For these reasons, the Commission declines to remove changes to credit account limits from the list of material additions or modifications. The Commission does recognize that the proposed rule did not set a threshold for a material change and that a lack of such a threshold could create uncertainty in the marketplace. Thus, the Commission has determined that the rule will require notifications for changes to credit account limits of $100 or greater. These are the types of changes that are monitored in at least one of the NCRA's consumer files. 32

Third, the proposed rule included inquiries or requests for a consumer report as a material addition or modification, with an exception for inquiries for prescreening or account review. The NPRM noted that notifying consumers of pre-screening or account review inquiries could result in over-notification, making it difficult for consumers to determine when an inquiry indicates that they are potentially the victim of identity theft or other fraud. The proposed rule did not include an exception for inquiries for the purposes of account collection, but the NPRM asked whether NCRAs have the ability to differentiate between account collection and account review inquiries.

CDIA's comment indicated that NCRAs cannot distinguish between account review and collection. 33 CDIA explained that the NCRAs only require companies to provide their permissible purpose for obtaining a consumer report, but that the permissible purpose for account review and account collection is the same. Thus, if the rule were to require notifications of inquiries made for account collection (as the proposed rule did), NCRAs would likely provide notifications of inquiries for account review, which could result in overnotification. Accordingly, CDIA recommended notification be limited to “inquiries or requests for a consumer report in connection with the establishment of a new credit plan or extension of credit, other than under an open-end credit plan (as defined in section 103(i)), 34 in the name of the consumer.”  35 CDIA noted that similar language is used elsewhere in the FCRA. 36

Given that the NCRAs do not differentiate between inquiries for account review and account collection, the Commission agrees that inquiries for account collection should be excepted. The Commission notes that if a company establishes a new collection account, the NCRA would already have to send a notification because new accounts are included in the list of material additions or modifications. To ensure that there is no ambiguity about that requirement, the Commission has decided to modify § 609.2(l)(1) to provide that significant changes to a consumer's file includes new accounts opened in the consumer's name, including new collection accounts. With respect to § 609.2(l)(2), the Commission declines to adopt CDIA's proposed language. The proposed language would only require notification for inquiries or requests for a consumer report in connection with a credit transaction. Thus, for example, military consumers would not receive a notification if an employer or insurer requested their report because someone applied for employment or insurance in their name, which could be indicative of identity theft. Therefore, the Commission has determined to modify § 609.2(l)(2)(i) to provide that an inquiry made for a prescreened list obtained for the purpose of making a firm offer of credit or insurance as described in 15 U.S.C. 1681b(c)(1)(B) or for the purpose of reviewing or collecting an account of the consumer shall not be considered a material addition or modification.

Finally, two commenters recommended adding a significant drop in credit score, such as 25 points or more, to the list of material additions or modifications. These commenters suggested that such a drop may indicate a significant change to the consumer's file, possibly due to fraud. 37 Military groups also noted that a large drop in credit score could signal a problem that leads to revocation of a military consumer's security clearance.

Although the Commission is sympathetic to these concerns, it declines to make this change. The rule already requires the NCRAs to provide a notification about events that would likely cause a significant drop in credit score, such as a delinquency. Beyond requiring notification of substantive events that would likely cause a significant drop in credit score, the Commission does not have information at this time to determine the feasibility and costs of this proposal. For example, it is not clear how often the NCRAs are calculating credit scores in the absence of a request from a consumer or creditor. Nor is it clear how much it would cost NCRAs to continuously monitor credit scores for the purpose of providing an alert when there is a significant drop. Thus, the Commission declines to include this change.

The NPRM defined “negative information” as having the meaning provided in 15 U.S.C. 1681s-2(a)(7)(G)(i), which in turn defines “negative information” to mean “information concerning a customer's delinquencies, late payments, insolvency, or any form of default,” in the context of furnishers providing information to the CRAs. The Commission received one comment on this definition. CDIA noted that the proposed definition does not provide enough specificity to the NCRAs as to when notification is required. 38 CDIA recommended that the Commission modify the definition as follows: Accounts furnished to the NCRAs as more than 30 days delinquent, accounts furnished to the NCRAs as being included in bankruptcy petition filings, and new public records (such as suits or judgments). The Commission believes that CDIA's proposed language covers the negative information that the Commission intended for the proposed rule to require notification of and therefore has decided to modify the language to provide the NCRAs greater specificity. The Commission is also adding additional detail to provide a non-exhaustive list of what types of new public records may constitute negative information. Thus, the Commission has decided to modify the definition of “negative information” as follows: Accounts furnished to the NCRAs as more than 30 days delinquent, accounts furnished to the NCRAs as being included in bankruptcy petition filings, and new public records, including, but not limited to, bankruptcy filings, civil court judgments, foreclosures, liens, and convictions.

The Commission received no comments on the proposed rule's definitions of “consumer,” “consumer report,” “contact information,” “credit,” “file,” “firm offer of credit,” and “nationwide consumer reporting agency.” The Commission adopts these definitions without modification.

Proposed § 609.3(a) required the NCRAs to provide a free electronic credit monitoring service to active duty military consumers. 39 Proposed § 609.3(b) allowed the NCRAs to condition provision of the service upon the consumer providing appropriate proof of identity; contact information; and appropriate proof that the consumer is an active duty military consumer. Proposed § 609.3(c) provided the methods for verifying a consumer's status as an active duty military consumer. Proposed § 609.3(d) limited the ways that the NCRAs can use or disclose the information collected from consumers as a result of a request to obtain the service. Proposed § 609.3(e) placed limitations on the types of communications that may surround enrollment in the service. Proposed § 609.3(f) prohibited asking or requiring a consumer to agree to terms or conditions in connection with obtaining the service.

The proposed rule required NCRAs to verify a consumer's status as an active duty military consumer through one of four methods: A copy of the consumer's active duty orders; a copy of a certification of active duty status issued by the DoD; a method or service approved by the DoD; or a certification of active duty status approved by the NCRA. The Commission requested comment on whether these methods are adequate or if other methods should be included. The Commission also asked whether it is burdensome for consumers to provide appropriate proof, and if so, if there are ways to minimize the burden.

The Commission received several comments on the methods for validating a consumer's active duty military consumer status. CDIA recommended that the Commission work with DoD to come up with an automated system to conclusively determine whether a consumer is eligible for the service and that will also verify the time period for which the consumer is eligible for the service. 40 Absent an automated system, CDIA stated that the Commission should clarify that the determination of active duty status is valid for two years and then must be renewed. Consumer groups similarly suggested that the NCRAs be allowed to use the DoD developed database that lenders use to comply with the Military Lending Act (“MLA”). 41

With respect to the requests for an automated system run by the DoD, the Commission notes that if DoD were to develop such a system, it would be considered “a method or service approved by the DoD” and thus would not require any modification to the rule. The Commission will work with the DoD to explore whether a DoD-run system or database is viable. 42 The Commission agrees that in the absence of an automated system, the rule should specify a period of time for which the determination of active duty status is valid. The Commission believes that the two-year time period suggested by CDIA is reasonable. Indeed, it is twice as long as the duration of an active duty military fraud alert. 43 Therefore, the Commission is adding a provision to the final rule establishing that an NCRA's verification of active duty military consumer status is valid for two years. After the expiration of the two-year period, the NCRA may require the consumer to provide proof that the consumer continues to be an active duty military consumer.

Military groups recommended that the Commission remove the option for a certification approved by the NCRA because it may allow inadequate methods of proof. 44 The Commission believes that it would benefit military consumers to allow the NCRAs to accept additional certifications of their choosing, such as having the consumer check a box certifying that they are an active duty military consumer. If the NCRA decides that the ease of such a method outweighs the risk that some consumers may misrepresent that they are eligible for the free service, any costs of such a determination would be borne by the NCRA.

Various commenters recommended additional methods of validation. One commenter raised concerns about whether the current methods of proof would cover members of the National Guard when not on active duty orders. 45 This commenter suggested that a current leave and earnings statement is a method of proof that would be available to the National Guard. 46 Another commenter suggested that a letter from the consumer's commanding officer should be appropriate proof. 47

The Commission understands the desire to provide military consumers and the NCRAs flexibility in the types of documentation that they can use to verify active duty military consumer status. In light of the fact that what constitutes appropriate proof for National Guard members will likely differ from that for active duty military more generally, the Commission has decided not to attempt to include a list of all suitable documents in the rule. Rather, to allow maximum flexibility, the Commission has decided to retain two of the methods from the proposed rule: (1) A method or service approved by the DoD; and (2) a certification of active duty status approved by the NCRA. The Commission notes that while it is removing the two additional methods that were in the proposed rule: (1) A copy of the consumer's active duty orders; and (2) a copy of a certification of active duty status issued by the DoD—those documents, as well as the additional documents recommended by the commenters, can still be incorporated into a certification method approved by DoD or the NCRA.

The Commission is also clarifying that the procedures that the NCRAs use to determine appropriate proof of active duty military consumer status must include methods that allow all eligible consumers to enroll. For example, an NCRA cannot decide that the only proof of status it will accept from a member of the National Guard is active duty orders, given that most members of the National Guard will not have active duty orders. To the extent that the NCRAs find it difficult to verify that individuals meet the definition of an “active duty military consumer,” particularly with respect to whether they are assigned to service away from their usual duty station, the Commission encourages the NCRAs to err on the side of providing the free service more broadly. To provide an incentive for the NCRAs to provide the free service to a broader set of military consumers and to reduce the likelihood that an eligible consumer is excluded from the free service, the Commission will deem an NCRA to be in compliance with this provision if it provides free electronic credit monitoring services to (1) consumers who self-certify active duty status, as defined in 10 U.S.C. 101(d); (2) consumers who self-certify that they are a reservist performing duty under a call or order to active duty under a provision of law referred to in 10 U.S.C. 101(a)(13); and (3) consumers who self-certify that they are a member of the National Guard, as defined in 10 U.S.C. 101(c).

The proposed rule limited the ways that the NCRAs can use or disclose the information collected from consumers as a result of a request to obtain the free electronic credit monitoring service. The proposed rule allowed NCRAs to use the information collected only: (1) To provide the free electronic credit monitoring service requested by the consumer; (2) to process a transaction requested by the consumer at the same time as a request for the service; (3) to comply with applicable legal requirements; or (4) to update information already maintained by the NCRA for the purpose of providing consumer reports, with certain limitations. The NPRM noted that these restrictions on use and disclosure are identical to the requirements placed on the NCRAs' collection of personally identifiable information from consumers using the centralized source for annual credit reports. 48 The Commission requested comment on whether the allowed uses and disclosures are appropriate and whether the rule should permit additional uses.

Several commenters supported these restrictions and noted that they would prevent the use of the personal information collected from military consumers for marketing or other unanticipated uses. 49 On the other hand, CDIA commented that the restrictions are unnecessary in light of the Commission's authority under Section 5 of the FTC Act to address unfair or deceptive acts or practices. 50 CDIA also argued that the restrictions are beyond the scope of the FTC's statutory authority under the Act. The American Financial Services Association commented that the Commission should ensure that the restrictions do not prevent the information's use for the purpose of studying the effect the MLA regulations are having on the availability of credit. 51

The Commission does not agree that the agency's Section 5 authority renders the proposed rule's restrictions unnecessary. Under Section 5, the Commission would be limited to pursuing a law enforcement action in circumstances where an NCRA deceived a military consumer or used or disclosed the information in a manner that caused or was likely to cause substantial injury that was not reasonably avoidable by consumer themselves and not outweighed by countervailing benefits to consumers or to competition. However, even in circumstances not involving deception or substantial injury, the Commission does not believe that it would be appropriate to make an active duty military consumer's access to the free electronic credit monitoring service contingent on the consumer's willingness to allow a NCRA to use the consumer's information for unrelated, secondary uses. The Commission believes that the use and disclosure restrictions are within its authority under the Act because they are necessary to ensure that the Act's purpose of providing active duty military consumers with free electronic credit monitoring is not undermined by consumers' concerns about secondary uses of their personal information. 52

With respect to the specific request to allow the information to be used for the purpose of studying the effect MLA regulations have on the availability of credit, the Commission declines to grant an exception to allow military consumers' personal information to be used for such a purpose, which is unrelated to their request for the free electronic credit monitoring. For these reasons, the Commission has decided to retain the proposed rule's information use and disclosure restrictions without modification.

Proposed §  609.3(e) placed limitations on the types of communications that may surround enrollment in the electronic credit monitoring service, similar to the restriction on advertising on the annual credit report website. 53 Proposed § 609.3(e)(1) restricted any advertising or marketing for products or services, or any communications or instructions that advertise or market any products and services, to a consumer who has indicated an interest in signing up for the free electronic credit monitoring service until after the consumer has enrolled in the service. Section 609.3(e)(2) of the proposed rule specified that any communications, instructions, or permitted advertising or marketing may not interfere with, detract from, contradict, or otherwise undermine the purpose of providing a free electronic credit monitoring service to active duty military consumers. Section 609.3(e)(3) of the proposed rule provided examples of conduct that would interfere with, detract from, contradict, or undermine the purpose of the rule. The Commission solicited comment on whether the limitations are necessary to ensure that active duty military consumers are able easily to obtain their free electronic credit monitoring service. The Commission also asked whether the limitations impose undue burdens on the NCRAs, and if so, whether there are ways to minimize the burdens. The Commission also asked whether there are more examples of prohibited conduct that should be included in the rule.

Consumer groups stated that the limitations are necessary to allow military consumers to get the free credit monitoring easily without encountering distracting advertising. 54 They further recommended that the Commission prohibit the NCRAs from representing or implying that the service is inferior to the NCRA's commercial credit monitoring services. They also recommended that the Commission prohibit the NCRAs from offering identity theft insurance at any time in connection with the free credit monitoring because of concerns about the usefulness of such insurance.

After carefully considering these suggestions, the Commission has decided not to add prohibitions beyond those already included in the proposed rule. Section 609.3(e)(3)'s prohibited communications are designed to ensure that active duty military consumers are not confused or deceived by communications related to a NCRA's products and services. If a NCRA makes a deceptive representation to consumers about its commercial credit monitoring products or identity theft insurance, the Commission can pursue an enforcement action under Section 5 of the FTC Act. Some consumers may be interested in paying an additional fee in order to obtain services that may not be available within the free electronic credit monitoring service. Therefore, given that the rule already prohibits marketing until after the consumer has enrolled in the free service, the Commission does not believe it is necessary to prohibit truthful advertising regarding the NCRA's products and services after enrollment.

CDIA stated that the restrictions are unnecessary and outside of the Commission's statutory authority under the Act. 55 CDIA also noted that unlike free annual credit reports, which the NCRAs offer through a centralized website, the NCRAs will offer the free electronic credit monitoring through their own commercial websites. CDIA argued that this makes it more difficult to determine when advertising is and is not permitted. CDIA criticized the proposed rule's standard of delaying marketing “once a consumer has indicated that the consumer is interested in obtaining the service . . . such as by clicking on a link for services” as ambiguous. Therefore, if the Commission retains the marketing limitations, CDIA requested additional clarification on this point to make clear that marketing is prohibited only during the enrollment process. CDIA recommended the following language for § 609.3(e)(1): “once a consumer is in the process of accessing the ability to enroll in the service required under paragraph (a) of this section and only during the enrollment process. . . .”

After considering the comments, the Commission has determined that retaining the restrictions on communications is necessary to further the Act's purpose of providing active duty military consumers with a free electronic credit monitoring service. These restrictions help ensure that active duty military consumers are not thwarted by confusing advertisements or communications that dissuade them from enrolling in the free service.

The Commission recognizes that the proposed rule's limitation on advertising from the time the consumer “has indicated an interest in signing up for the free electronic credit monitoring service” may have been unclear. The Commission did not intend to ban advertising on all web pages of the NCRAs; rather, it sought to limit advertising on pages that are part of the product enrollment process. To provide greater clarity, the Commission has decided to modify § 609.3(e)(1) to provide that once a consumer is in the process of accessing the ability to enroll in the service required under paragraph (a) and only during the enrollment process, any advertising or marketing for products or services, or any communications or instructions that advertise or market any products and services, must be delayed until after the consumer has enrolled in that service. The Commission interprets this to mean that the NCRAs shall not advertise on the pages of the NCRA's website or app dedicated to providing active duty military consumers with their rights under this regulation, until after the consumer has enrolled in the service.

The proposed rule also prohibited asking or requiring an active duty military consumer to agree to terms or conditions in connection with obtaining a free electronic credit monitoring service. The Commission asked whether this prohibition is necessary; whether CRAs currently require customers of commercial credit monitoring services to agree to terms or conditions; and whether the prohibition imposes undue burdens on the NCRAs. Commenters that supported the inclusion of these prohibitions specifically pointed out that without them, the NCRAs could require military consumers to agree to mandatory arbitration clauses in order to receive free credit monitoring. 56 However, CDIA commented that the prohibitions are unnecessary and outside of the FTC's statutory authority under the Act. 57 CDIA also expressed concern that the NCRAs would be in violation of these prohibitions if they sought to condition providing the service on the provision of appropriate proof of identity, contact information, and appropriate proof of active duty military status, as required by the proposed rule. CDIA further posited that seeking the consumer's written instructions to comply with the FCRA's permissible purpose requirements or consent to receive text notifications pursuant to the Telephone Consumer Protection Act could violate this provision.

As the NPRM noted, this restriction is similar to the restriction for the annual credit report website. 58 The Commission believes it is within its statutory authority to ensure that an active duty military consumer's right to obtain a free electronic credit monitoring service is unfettered and without any restrictions or conditions, apart from providing appropriate proof of identity, contact information, and appropriate proof that the consumer is an active duty military consumer. The Commission believes that allowing the NCRAs to condition provision of the free electronic credit monitoring service on the consumer's agreement to a variety of terms and conditions could dissuade military consumers from availing themselves of the service. However, the Commission recognizes that there may be certain instances in which legal requirements may require the NCRAs to receive consumers' consent for certain aspects of the service. Thus, the Commission has decided to retain the prohibition with the following modification: A NCRA shall not ask or require an active duty military consumer to agree to terms or conditions in connection with obtaining a free electronic credit monitoring service, other than those terms or conditions required to comply with applicable legal requirements.

The proposed rule required that the electronic notifications be provided within 24 hours of any material additions or modifications to a consumer's file. The Commission requested comment on whether the proposed rule's 24-hour timing was appropriate. The Commission received one comment on the timing requirements. CDIA commented that the timing requirement is outside of the Commission's statutory authority and that it should be kept out of the final rule. It recommended that if the timing requirement remains, the Commission should instead require notifications within 48 hours to be consistent with the NCRA's commercial credit monitoring services. CDIA also recommended that the Commission provide a safe harbor for NCRAs to provide notifications within the same timing that they use for their commercial credit monitoring services. 59

The Commission believes it is necessary and within its statutory authority under the Act to specify the time within which electronic notifications must be made. If military consumers are not notified of the material additions or modifications to their files within a reasonable amount of time, the electronic credit monitoring service would not be as effective. For example, if a consumer is notified promptly about a new account that has been fraudulently opened in his or her name and appears on his or her consumer report, he or she may decide to place a fraud alert or security freeze on their file, which may help prevent the opening of additional fraudulent accounts. The Commission declines to give the NCRAs a safe harbor for providing the notifications within the same timing that they use for their commercial credit monitoring products because that timing could change in the future, and the Commission believes it is necessary to set a baseline. However, the Commission has decided to modify the timing requirement to require notification within 48 hours of any material additions or modifications to a consumer's file. This will align the requirement with the timing that CDIA states the NCRAs currently use for their commercial services, while still requiring that the NCRAs provide the notifications in a prompt manner upon making a change to the consumer's file. 60

The proposed rule also required that the electronic notifications include a hyperlink to a summary of the consumer's rights under the FCRA, as prescribed by the Bureau of Consumer Financial Protection. 61 The Commission noted that it would be useful for consumers to be able to easily access information about their rights to, for example, obtain consumer reports and dispute information on their reports. The Commission requested comment on whether requiring this link would provide useful information to consumers and whether there is a different method of providing this information that would be more effective.

Consumer groups commented that the Commission should also require the provision of the Summary of Rights of Identity Theft Victims outlined in 15 U.S.C. 1681g(d). 62 While the Commission agrees that the Summary of Rights for Identity Theft Victims also provides useful information for consumers, the Commission does not believe it is appropriate to mandate its inclusion in the electronic notifications. The language of that document contemplates that it will be given to consumers when they have contacted a CRA about being the victim of identity theft, which likely will not be true for many of the recipients of the electronic credit monitoring notices. 63

NCLC also recommended that the Commission require a more prominent method of providing the summary of rights, such as including the document in the same email or web page, rather than just a hyperlink. 64 NCLC also suggested that if the rule requires access to the credit report following a notification, the summary of rights could be appended to the report. On the other hand, CDIA commented that it had no objections to the general requirement, but expressed concern about including the hyperlink in text message or mobile application notifications, which may be space limited. CDIA recommended that the NCRAs have the flexibility to provide the link on any page within the electronic credit monitoring service to which the notification may direct the consumer.

Given the space constraints in text messages and mobile applications, the Commission will modify the rule to allow the NCRAs to provide the link to the summary of rights on the first page of the website to which the electronic notification may direct the consumer. The Commission will also modify the rule to require that the summary of rights be included with the credit report that consumers can choose to access following the receipt of a notification, as required when a consumer requests a copy of their file under section 609 of the FCRA, 15 U.S.C. 1681g.

Proposed § 609.6 stated that the provisions of the proposed rule are separate and severable from one another, so that if any provision was stayed or determined to be invalid, it was the Commission's intention that the remaining provisions shall continue in effect. The Commission received no comments on this provision and adopts it without modification.

The proposed rule did not address the date by which the NCRAs will be required to comply with the rule. CDIA commented that the rule needs to provide an appropriate amount of time for the NCRAs to implement the service required by the rule. 65 CDIA stated that one year from the effective date would be necessary, but that the time could be reduced if the NCRAs are given a safe harbor for providing their existing credit monitoring services to active duty military consumers for free.

The Commission recognizes that the NCRAs will need time following the publication of the final rule to implement the service. For example, they will likely need to create systems to accept proof of active duty military status. They may need to make engineering and product changes to generate alerts about certain changes to a credit file. However, the Commission also notes that Congress gave the Commission only one year from the enactment of the Act to promulgate these regulations, presumably to ensure that active duty military consumers receive the free credit monitoring sooner rather than later. For example, Senators Carper and Coons, who drafted the credit monitoring provision of the Act, requested that the Commission, “conclude the rulemaking process expeditiously so that servicemembers may begin benefiting from this service as soon as possible.”  66

Balancing these factors, the Commission has determined to set a compliance date of 3 months from the effective date of these regulations. However, to give the NCRAs additional time to set up their systems, while still allowing consumers to benefit from the new rights created by the Act, the Commission will allow the NCRAs to comply with §§ 609.3(a), 609.4, and 609.5 by offering their commercial credit monitoring service for free, for a period of up to one year from the effective date of the rule.

The Paperwork Reduction Act (PRA), 44 U.S.C. chapter 35, requires federal agencies to seek and obtain OMB approval before undertaking a collection of information directed to ten or more persons. 67 Under the PRA, a rule creates a “collection of information” when ten or more persons are asked to report, provide, disclose, or record information in response to “identical questions.”  68 As the notification requirements fall upon the three NCRAs, it does not meet the PRA threshold count of ten or more persons to constitute a “collection of information.” Further, the proof of identity the rule requires of those for whom the rulemaking is designed to benefit, consumers on active duty military status, falls within OMB's general exception for disclosures that require persons to provide or display only facts necessary to identify themselves. 69

The Regulatory Flexibility Act (RFA)  70 requires that the Commission conduct an initial and a final analysis of the anticipated economic impact of the rule on small entities. The purpose of a regulatory flexibility analysis is to ensure the agency considers the impacts on small entities and examines regulatory alternatives that could achieve the regulatory purpose while minimizing burdens on small entities. The RFA  71 provides that such an analysis is not required if the agency head certifies that the regulatory action will not have a significant economic impact on a substantial number of small entities.

The Commission believes that the rule will not have a significant economic impact on small entities. The final rule applies to NCRAs. The Commission has not identified any NCRAs that are small entities. 72 Therefore, the Commission certifies that the rule will not have a significant economic impact on a substantial number of small businesses.

The final rule is similar to the rule proposed in the NPRM. In its Initial Regulatory Flexibility Analysis (IRFA), the Commission determined that the proposed rule would not have a significant impact on small entities because the NCRAs to which the proposed rule would apply were not small entities.

Although the Commission certifies under the RFA that the rule will not have a significant impact on a substantial number of small entities, and hereby provides notice of that certification to the Small Business Administration, the Commission nonetheless has determined that publishing a final regulatory flexibility analysis (FRFA) is appropriate to ensure that the impact of the rule is fully addressed. Therefore, the Commission has prepared the following analysis:

The Economic Growth, Regulatory Relief, and Consumer Protection Act, Public Law 115-174, directs the Commission to promulgate regulations to implement section 302(d)(1) of the Act, which shall at a minimum: (1) Define “electronic credit monitoring service” and “material additions or modifications to the file of a consumer,” and (2) establish what constitutes appropriate proof that a consumer is an active duty military consumer. In this action, the Commission issues a rule that would fulfill the statutory mandate. The Act requires that the Commission promulgate this rule not later than one year after the date of enactment, or May 24, 2019.

The Commission did not receive any comments that addressed the burden on small entities.

The final rule will apply only to NCRAs. The Commission has not identified any NCRAs that are small entities.

Under the final rule, NCRAs will have to provide free electronic credit monitoring services to active duty military consumers. There are no reporting or recordkeeping requirements, or types of professional skills necessary for preparation of any such report or record, under the rule. In any event, as noted earlier, the final rule applies only to NCRAs, and they are not small entities.

The Commission has not identified any particular alternative methods of compliance as necessary to reduce burdens on small entities, because the Commission does not believe any NCRAs subject to the final rule are small entities, as noted earlier.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a “major rule,” as defined by 5 U.S.C. 804(2).

We are adopting an updated EDGAR Filer Manual, Volumes I and II. The Filer Manual describes the technical formatting requirements for the preparation and submission of electronic filings through the EDGAR system. 1 It also describes the requirements for filing using EDGARLink Online and the EDGAR Online Forms website.

The revisions to the Filer Manual reflect changes within EDGAR Filer Manual, Volume I: “General Information,” (Version 33) and EDGAR Filer Manual, Volume II: “EDGAR Filing,” (Version 51) (June 2019). The updated Filer Manual is incorporated by reference into the Code of Federal Regulations.

The Filer Manual contains all the technical specifications for filers to submit filings using the EDGAR system. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format. 2 Filers should consult the Filer Manual in conjunction with our rules governing mandated electronic filings when preparing documents for electronic submission.

The EDGAR System was updated in Release 19.2 and corresponding amendments to the Filer Manual are being made to reflect the changes described below.

EDGAR Release 19.2 introduced changes to the EDGAR Filer Management Interface that provide a more modernized interface for completing an application for EDGAR access using the Form ID. Volume I of the Filer Manual is being revised to provide filers with instructions to use the more modernized interface to complete and submit Form ID. See Chapter 3 (Becoming an EDGAR Filer) of the EDGAR Filer Manual, Volume I: “General Information.”

In Release 33-10618, 3 the Commission modernized and simplified certain requirements of Regulation S-K and related rules and forms, and made parallel amendments to several rules and forms applicable to investment companies and investment advisers. As part of those amendments, filers are required to tag in Inline XBRL information on the cover pages of annual reports on Forms 10-K, 20-F and 40-F, quarterly reports on Form 10-Q, and current reports on Form 8-K. EDGAR has been updated to provide filers with the ability to include cover page tags within any Inline XBRL document set for submission form types 10-K, 10-K/A, 10-KT, 10-KT/A, 10-Q, 10-Q/A, 10-QT, 10-QT/A, 8-K, 8-K/A, 8-K12B, 8-K12B/A, 8-K12G3, 8-K12G3/A, 8-K15D5, 8-K15D5/A, 20-F, 20-F/A, 20FR12B, 20FR12B/A, 20FR12G, 20FR12G/A, 40-F, 40-F/A, 40FR12B, 40FR12B/A, 40FR12G, and 40FR12G/A. EDGAR validation has been enhanced to help filers identify any required tags that are missing or incomplete. Please refer to Chapter 5 (Constructing Attached Documents and Document Types), Chapter 6 (Interactive Data), and Appendix E (Automated Conformance Rules for EDGAR Data Fields) of the EDGAR Filer Manual, Volume II: “EDGAR Filing.”

In addition, EDGAR has been updated to permit HTML documents that are included in online submissions to include references to modules and segments constructed in either ASCII or HTML format. See Chapter 5 (Constructing Attached Documents and Document Types), Chapter 6 (Interactive Data), and Appendix A (Messages Reported by EDGAR) of the EDGAR Filer Manual, Volume II: “EDGAR Filing.”

EDGAR Release 19.2 made changes to how Schedule C of submission form type MA/A and MA-A presents a “Summary of Schedule C Changes” button to display only newly added, edited, or deleted entries. Explanations of the changes are being added to Chapter 8 (Preparing and Transmitting Online Submissions) of the EDGAR Filer Manual, Volume II: “EDGAR Filing.”

Submission form types ATS-N, ATS-N/MA, ATS-N/UA, ATS-N/CA, ATS-N/OFA, ATS-N-C, and ATS-N-W were updated with revised error messages to indicate that invalid characters are not allowed in free-text fields. Filers should refer to Chapter 5 (Constructing Attached Documents and Document Types) of the EDGAR Filer Manual, Volume II: “EDGAR Filing” for more details on EDGAR acceptable characters. See Chapter 8 (Preparing and Transmitting Online Submissions) of the EDGAR Filer Manual, Volume II: “EDGAR Filing.”

In EDGAR Release 19.2, the EDGAR system was updated to support the 2019 IFRS Taxonomy. Also, EDGAR no longer supports the superseded 2017 US-GAAP, 2017EXCH and 2016 CURRENCY Taxonomies. 4

In Release 33-10231, 5 the Commission rescinded Form N-SAR as of June 1, 2018. 6 Following a full year from the rescission of Form N-SAR, this Release removes Volume III and amends Section 301 of Regulation S-T by removing the fourth sentence “Additional provisions applicable to Form N-SAR filers are set forth in the EDGAR Filer Manual, Volume III: “N-SAR Supplement,” Version 6 (January 2017).” In addition, the EDGAR Filer Manual is being updated to inform filers that EDGAR will no longer accept submissions of Form N-SAR and related subtypes.

Along with the adoption of the Filer Manual, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference into the Code of Federal Regulations of the current revisions. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

The updated EDGAR Filer Manual is available for website viewing and printing; the address for the Filer Manual is https://www.sec.gov/info/edgar/edmanuals.htm. You may also obtain paper copies of the EDGAR Filer Manual from the following address: Public Reference Room, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m.

Because the Filer Manual and the corresponding rule and form amendments relate solely to agency procedures or practice, publication for notice and comment is not required under the Administrative Procedure Act (“APA”). 7 It follows that the requirements of the Regulatory Flexibility Act  8 do not apply.

The effective date for the updated Filer Manuals and the related rule and form amendments is July 1, 2019. In accordance with the APA, 9 we find that there is good cause to establish an effective date less than 30 days after publication of these rules. The Commission believes that establishing an effective date less than 30 days after publication of these rules is necessary to coordinate the effectiveness of the updated Filer Manuals with these system upgrades.

We are adopting the amendments to Regulation S-T under the authority in Sections 6, 7, 8, 10, and 19(a) of the Securities Act of 1933, 10 Sections 3, 12, 13, 14, 15, 15B, 23, and 35A of the Securities Exchange Act of 1934, 11 Section 319 of the Trust Indenture Act of 1939, 12 and Sections 8, 30, 31, and 38 of the Investment Company Act of 1940. 13

In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows:

Background

The final regulations (TD 9857) that are the subject of this correction are issued under section 987 of the Internal Revenue Code.

As published May 13, 2019 (84 FR 20790) the final regulations (TD 9857) contain errors that need to be corrected.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

In compliance with the Privacy Act, 5 U.S.C. 552a(e)(4), ODNI has already described in the notice section of the Federal Register (83 FR 61395, document 18-25970), published on November 29, 2018, the following new system of records: Continuous Evaluation System (ODNI/NCSC-003). This new system of records facilitates implementation of the National Counterintelligence and Security Center (NCSC) Continuous Evaluation system, which conducts ongoing automated checks of security-relevant databases to ensure that individuals who have been determined to be eligible for access to classified information or to hold a sensitive position remain eligible, as required by Executive Orders 12968 as amended (Access to Classified Information), and 13467 as amended (Reforming Processes Related to Suitability for Government Employment, Fitness for Contractor Employees, and Eligibility for Access to Classified National Security Information). The system of records will contain biographic and personnel security-relevant records pertaining to current Executive Branch employees, detailees, contractors, and other sponsored individuals (enrollees).

In its final rule, the ODNI exempts the above new system of records, Continuous Evaluation System (ODNI/NCSC-003), from certain provisions of the Privacy Act to prevent the compromise of classified information and to ensure the integrity of any law enforcement, counterintelligence, or administrative investigation that may be undertaken with respect to the subject of the record.

In addition, this ODNI final rule restores and updates the list of ODNI exempt systems of records at 32 CFR 1701.22, as redesignated. The original list had been deleted by final action published at 80 FR 63427 (October 20, 2015). The restored list reflects the updated break-down of exempt systems of records by ODNI component.

This final rule affects the manner in which ODNI collects and maintains information about individuals. ODNI certifies that this rulemaking does not have a significant economic impact on a substantial number of small entities. Accordingly, pursuant to the Regulatory Flexibility Act, 5 U.S.C. 601-612, no regulatory flexibility analysis is required for this rule.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires ODNI to comply with small entity requests for information and advice about compliance with statutes and regulations within ODNI jurisdiction. Any small entity that has a question regarding this document may address it to the information contact listed above. Further information regarding SBREFA is available on the Small Business Administration's web page at http://www.sga.gov/advo/law/law_lib.html.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that ODNI consider the impact of paperwork and other burdens imposed on the public associated with the collection of information. There are no information collection requirements associated with this final rule and therefore no analysis of burden is required.

This final rule is not a “significant regulatory action” within the meaning of Executive Order 12866. This rule does not have an annual effect on the economy of $100 million or more or otherwise adversely affect the economy or sector of the economy in a material way; does not create inconsistency with, or interfere with, other agency action; does not materially alter the budgetary impact of entitlements, grants, fees, or loans or the rights and obligations of recipients thereof; and does not raise legal or policy issues arising out of legal mandates, the President's priorities or the principles set forth in the Executive Order. Accordingly, further regulatory evaluation is not required.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, 109 Stat. 48 (Mar. 22, 1995), requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. This final rule imposes no Federal mandate on any State, local, or tribal government or on the private sector. Accordingly, no UMRA analysis of economic and regulatory alternatives is required.

Executive Order 13132 requires ODNI to examine the implications for the distribution of power and responsibilities among the various levels of government resulting from this final rule. ODNI concludes that the final rule does not affect the rights, roles and responsibilities of the States, involves no preemption of State law, and does not limit State policymaking discretion. This rule has no federalism implications as defined by the Executive Order.

ODNI has reviewed this action for purposes of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321-4347, and has determined that this action does not have a significant effect on the human environment.

The energy impact of this action has been assessed in accordance with the Energy Policy and Conservation Act (EPCA), Public Law 94-163, as amended, 42 U.S.C. 6362. This rulemaking is not a major regulatory action under the provisions of the EPCA.

For the reasons set forth above, ODNI amends 32 CFR part 1701 as follows:

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone by July 4, 2019 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to provide for the safety of life on these navigable waters.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with the fireworks display occurring on July 4, 2019 will be a safety concern for anyone within a 1,000-foot radius of the fireworks display. This rule is necessary to protect personnel, vessels, and the marine environment before, during, and after the scheduled firework displays.

This rule establishes a safety zone from 9 p.m. until 10 p.m. on July 4, 2019. The safety zone will cover all navigable waters within 1,000 feet of the fireworks barge located in the approximate position 027°48′05.51″ N, 097°23′13.89″ W in Corpus Christi, TX. The duration of the zone is intended to protect personnel, vessels, and the marine environment before, during, and after the scheduled firework displays. No vessel or person will be permitted to enter the safety zones without obtaining permission from the COTP or a designated representative.

Entry into the safety zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Corpus Christi. Persons or vessels desiring to enter or pass through the zones must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 361-939-0450. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs) of the enforcement times and dates for the safety zones.

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

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

This regulatory action determination is based on the size, duration, and location of the safety zone. This rule will impact a small designated area of the Corpus Christi Bay for 1 hour during a time that vessel traffic is normally low. Moreover, the Coast Guard will issue BNMs via VHF-FM marine channel 16 about the zones and the rule allows vessels to seek permission to enter the zones.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary fixed safety zone around display barge located in Corpus Christi Bay at position 27°48′05.51″ N, 097°23′13.89″ W. It is categorically excluded from further review under paragraph L60(A), in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the safety zones in 33 CFR 165.918 as per the time, dates, and locations in Table 1.

This action is being taken to provide for the safety of life on navigable waterways during the fireworks displays. The regulations for safety zones within the Captain of the Port Sault Sainte Marie Zone, § 165.918, apply for these fireworks displays.

This notice of enforcement is issued under authority of 33 CFR 165.918 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. If the Captain of the Port Sault Sainte Marie determines that the safety zone need not be enforced for the full duration stated in this notice of enforcement he or she may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone.

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor did not submit notice to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest by inhibiting the Coast Guard's ability to protect spectators and vessels from the hazards associated with a fireworks display.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . For the same reasons discussed in the preceding paragraph, waiting for a 30-day notice period to run would be impracticable and contrary to the public interest.

The legal basis for the rule is the Coast Guard's authority to establish safety zones under 46 U.S.C. 70034 (previously 33 U.S.C. 1231), 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6 and 160.5; Department of Homeland Security Delegation No. 0170.1.

The Captain of the Port Buffalo (COTP) has determined that a fireworks display presents significant risks to the public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone prior to, during, and immediately after the fireworks display.

This rule establishes a safety zone from 10 p.m. through 10:30 p.m. on July 4, 2019. In the case of inclement weather on July 4, the safety zone will be enforced at the same times on July 5, 2019. The safety zone will cover all navigable waters of Lake Erie at the Buffalo Outer Harbor, Buffalo, NY contained within a 560-foot radius of: 42°52′07.93″ N, 078°53′01.86″ W.

The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the fireworks event takes place. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the COTP or a designated representative.

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

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

This regulatory action determination is based on the conclusion that this rule is not a significant regulatory action. We anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the COTP.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a temporary safety zone lasting only a half hour that will prohibit entry within the established safety zone for the fireworks display. It is categorically excluded from further review under paragraph L[60](a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. Recent flooding in the area prompted the need for a sudden change in the launch site for the annual fireworks display from the location published in 33 CFR 165.801 Table 2, Line 19, Davenport One Chamber, Red White and Boom to a location approximately one-half mile up-river and immediate action is needed to respond to the potential safety hazards associated with the fireworks display. It is impracticable to publish an NPRM because we must establish this safety zone by July 3, 2019 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the change in the fireworks display location.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper Mississippi River (COTP) has determined that potential hazards associated with a fireworks display on July 3, 2019 will be a safety concern for anyone on the Upper Mississippi River between Mile Marker (MM) 483 and MM 484. This rule resulted from a sudden change in the launch site for the fireworks display from the location published in 33 CFR 165.801 Table 2, line 19, Davenport One Chamber, Red White and Boom. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone before, during, and after the fireworks display.

This rule establishes a safety zone from 9 p.m. until 10:30 p.m. on July 3, 2019. The safety zone will cover all navigable waters of the Upper Mississippi River between MM 483 and 484. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters before, during, and after an annual fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The COTP or a designated representative will inform the public of the enforcement date and times for this safety zone, as well as any emergent safety concerns that may delay the enforcement of the zone through Broadcast Notice to Mariners (BNM), Local Notices to Mariners (LNMs), and/or actual notice.

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

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

This regulatory action determination is based on the duration and location of the temporary safety zone. This action involves an annually recurring fireworks display that is only changing location to a site approximately one-half mile up-river due to recent flooding in the area and only impacts a one-mile stretch of the Upper Mississippi River for a short amount of time. All other details of this event remain as published in 33 CFR 165.801 Table 2, line 19, Davenport One Chamber, Red White and Boom.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting one and one-half hours that will prohibit entry on the Upper Mississippi River between MM 483 and MM 484. It is categorically excluded from further review under paragraph L60(d) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

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

The background for this action is discussed in detail in our April 24, 2019 proposed approval (84 FR 17129). In that document we proposed to approve the revisions to the City of Albuquerque-Bernalillo County minor NSR preconstruction permitting program submitted on January 18, 2018 and to convert the conditional approval of the minor NSR permitting program to a full approval. The proposal addressed the County's submittal regarding accelerated permitting procedures, technical permit revisions, and conflict of interest and we found the submitted revisions to be consistent with the required elements of minor NSR programs at 40 CFR 51.160-51.164. We did not receive any comments regarding our proposal.

We are approving revisions to the City of Albuquerque-Bernalillo County minor NSR permitting program submitted on January 18, 2018. The revisions were adopted and submitted in accordance with the requirements of the CAA and federal regulations regarding SIP development at 40 CFR part 51. Additionally, we have determined that the submitted revisions to the City of Albuquerque-Bernalillo County minor NSR program are consistent with federal regulations at 40 CFR 51.160-51.164 and the associated policy and guidance. Therefore, under section 110 of the Act, the EPA approves into the New Mexico SIP for the City of Albuquerque-Bernalillo County the following revisions adopted November 8, 2017, and submitted to the EPA on January 18, 2018:

• 20.11.41.13 NMAC, Application for Permit;

• 20.11.41.14 NMAC, Public Notice by Department—Public Participation;

• 20.11.41.15 NMAC, Public Information Hearing (PIH);

• 20.11.41.28 NMAC, Administrative and Technical Permit Revisions; and

• 20.11.41.32 NMAC, Accelerated Review of Application.

We are also approving the following definitions since they are consistent with federal requirements for minor NSR permitting. Specifically, the EPA is approving the definition of “conflict of interest” at 20.11.41.7.J NMAC, the definition of “technical permit revision or technical revision” at 20.11.41.7.RR NMAC; as well as, the references to “technical permit revisions” in the definition of “permit” at 20.11.41.7.EE NMAC. Because of our final approval of the January 18, 2018, submitted revisions, we are converting our prior conditional approval of the City of Albuquerque-Bernalillo County minor NSR permitting program to a full approval. This action is being taken under section 110 of the Act.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the revisions to the New Mexico regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 6 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated in the next update to the SIP compilation.

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

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

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 30, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On May 16, 2019 (84 FR 22087), EPA published a Notice of Proposed Rulemaking (NPRM) for the Commonwealth of Massachusetts. The NPRM proposed approval of a SIP revision consisting of the second 10-year limited maintenance plan (LMP) for Carbon Monoxide (CO) for the Boston Metropolitan Area, as well as for the cities of Lowell, Springfield, Waltham, and Worcester. The formal SIP revision was submitted by Massachusetts on February 9, 2018.

Other specific requirements for a second maintenance plan covering a second 10-year maintenance period, the utilization of the LMP option, and the rationale for EPA's proposed action are explained in the NPRM and will not be restated here. No public comments were received on the NPRM.

EPA is approving Massachusetts' second 10-year LMP for CO, for the Boston Metropolitan area, Lowell, Springfield, Waltham, and Worcester, as a revision to the Massachusetts SIP. EPA is also approving Massachusetts' alternative CO monitoring strategy for the Springfield area. EPA's approval of this LMP satisfies the CAA section 175A requirements for the second 10-year period in the aforementioned CO maintenance areas.

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

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

• This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;

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

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

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

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

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

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

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit byAugust 30, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing 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-2018-0630 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 30, 2019. 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-2018-0630, 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 December 21, 2018 (83 FR 65660) (FRL-9985-67), 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 7E8638) by Bayer CropScience, 2.T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.661 be amended by establishing tolerances for residues of the fungicide fluopyram, N-[2-[3-chloro, -5-(trifluoromethyl)-2- pyridinyl] ethyl]-2-(trifluoromethyl) benzamide in or on cranberry at 2.0 parts per million (ppm); dry peas at 0.70 ppm; and lentils at 0.70 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, 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 is establishing, in accordance with section 408(d)(4)(a)(i), tolerances that vary in some respects from what the petitioner requested. These variations and the Agency's underlying rationale for those variations 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 fluopyram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluopyram 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.

Decreased body weight and liver effects were the common and frequent findings in the fluopyram subchronic and chronic oral toxicity studies in rats, mice, and dogs, and they appeared to be the most sensitive effects. Liver effects were characterized by increased liver weight, hepatocellular hypertrophy, hepatocellular vacuolation, increased mitosis and hepatocellular necrosis. Thyroid effects were found at dose levels similar to those that produced liver effects in rats and mice; these effects consisted of follicular cell hypertrophy, increased thyroid weight, and hyperplasia at dose levels greater than or equal to 100 milligrams/kilogram/day (mg/kg/day). Changes in thyroid hormone levels were also seen in a subchronic toxicity study. In male mice, there was an increased incidence of thyroid adenomas.

Although increased liver tumors were observed in female rats in the carcinogenicity study, EPA has concluded that fluopyram is “Not Likely to be Carcinogenic to Humans” at doses that do not induce cellular proliferation in the liver or thyroid glands. This classification was based on convincing evidence that non-genotoxic modes of action for liver tumors in rats and thyroid tumors in mice have been established and that the carcinogenic effects have been demonstrated as a result of a mode of action dependent on activation of the CAR/PXR receptors. The Agency is using a point of departure for regulating fluopyram (NOAEL of 1.2 mg/kg/day) that is below the doses that cause cell proliferation in the liver (11 mg/kg/day) and subsequent liver tumor formation (89 mg/kg/day); therefore, the Agency concludes that exposure to fluopyram will not be carcinogenic.

Moreover, fluopyram is not genotoxic or mutagenic. Fluopyram is not a developmental toxicant, nor did it adversely affect reproductive parameters. No evidence of qualitative or quantitative susceptibility was observed in developmental studies in rats and rabbits or in a multigeneration study in rats. In an acute neurotoxicity study, transient decreased motor activity was seen only on the day of treatment, but no other findings demonstrating neurotoxicity were observed. In addition, no neurotoxicity was observed in the subchronic neurotoxicity study in the presence of other systemic adverse effects. Fluopyram did not produce treatment-related effects on the immune system.

Fluopyram has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Fluopyram is not a skin or eye irritant or sensitizer under the conditions of the murine lymph node assay.

Specific information on the studies received and the nature of the adverse effects caused by fluopyram 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 document Fluopyram. Human Health Risk Assessment in Support of Tolerances without U.S. Registration on Lentils, Dry Peas, and Cranberries at pages 4-6 and page 12 in docket ID number EPA-HQ-OPP-2018-0630.

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 fluopyram used for human risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluopyram, EPA considered exposure under the petitioned-for tolerances as well as all existing fluopyram tolerances in 40 CFR 180.180.661. EPA assessed dietary exposures from fluopyram 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 fluopyram. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, the acute dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). The assessment is based on 100 percent crop treated (PCT) and tolerance-level residues for all commodities. Default and empirical processing factors were used in the assessment. Additionally, certain correction factors for metabolites were also incorporated.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA Nationwide Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, the chronic dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). In the assessment, average field trial residues and average PCT were used. Empirical processing factors were included for processed commodities where available. Otherwise, DEEM 2018 default processing factors were used.

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

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

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

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

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

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

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

The Agency estimated the average PCT for existing uses as follows: Almonds, 20%; apples, 25%; apricots, 5%; artichoke, 15%; broccoli, 2.5%; cabbage, 2.5%; carrots, 1%; cauliflower, 1%; cherries, 25%; cotton, 1%; dry beans and peas, 1%; grapefruit, 10%; grapes, raisins, 1%; table grapes, 5%; wine grapes; 20%; lemons, 1%; lettuce, 1%; onions, 1%; oranges, 15%; peaches, 1%; peanuts, 2.5%; pears, 5%; peppers, 5%; pistachios, 15%; potatoes, 20%; strawberries, 10%; tomatoes, 1%; walnuts, 10%; and watermelons, 15%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figures for each existing use are derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

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

Based on the Surface Water Concentration Calculator (SWCC) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of fluopyram for acute exposures are estimated to be 50.6 parts per billion (ppb) for surface water and 97.6 ppb for ground water. For chronic exposures for non-cancer assessments, the EDWCs of fluopyram are estimated to be 17.3 ppb for surface water and 90.5 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 97.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 90.5 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).

Fluopyram is currently registered for use on golf course turf, residential lawns, fruit trees, nut trees, ornamentals and gardens that could result in residential exposures. EPA assessed residential exposure using the following assumptions. For residential handler exposure, EPA assessed short-term dermal and inhalation handler exposure (derived from treating lawns by hose-end sprayers in adults). For residential post-application exposures, EPA assessed dermal exposure scenarios (for adults and children (1 to <2 years old) dermal exposure to treated turf during high contact lawn activities; for adults and youths (11 to <16 yr old) dermal exposure to treated turf during mowing and golfing activities; for children (6 to <11 years old) dermal exposure to treated turf during golfing activities; and for adults and children (6 to <11 years old) dermal exposure to treated gardens) and oral exposure (for children (1 to <2 years old) incidental oral exposure as a result of contacting treated turf). The Agency used the most conservative residential risk estimates (from the adult inhalation handler exposures from treating lawns with hose-end sprayer and from the child (1 to <2 years old) incidental oral hand-to-mouth post-application exposures to treated lawns) in the fluopyram aggregate assessment. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.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 fluopyram to share a common mechanism of toxicity with any other substances, and fluopyram does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluopyram 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 website 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. There is no evidence of increased susceptibility in the developing or young animals which were exposed during pre- or post-natal periods.

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 fluopyram is complete.

ii. There is no indication that fluopyram is a neurotoxic chemical. Although transient decreases in motor and locomotor activities in the acute neurotoxicity study were seen on the day of treatment and limited use of hind-limbs and reduced motor activity was seen in the rat chronic/carcinogenicity study, there were no other associated neurobehavioral or histopathology changes found in other studies in the fluopyram toxicity database. The effects seen in the chronic/carcinogenicity study were in the presence of increased mortality and morbidity such as general pallor and emaciated appearance. Therefore, the reduced motor activity and limited use of hind-limbs seen in these two studies were judged to be the consequence of the systemic effects and not direct neurotoxicity. Additionally, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that fluopyram results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary exposure assessment was performed using conservative exposure inputs, including tolerance-level residues for all crops, whereas the chronic dietary assessment included average field-trial residue levels for all crops. The acute dietary assessment assumed 100 PCT, whereas the chronic dietary assessment utilized average PCT numbers for several crops. Both acute and chronic dietary assessments incorporated empirical or default processing factors. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluopyram 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 fluopyram.

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 fluopyram will occupy 30% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluopyram from food and water will utilize 84% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluopyram 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).

Fluopyram 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 fluopyram. 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 1500 for adults and 1400 for children (1 to <2 years old). Because EPA's level of concern for fluopyram 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, fluopyram 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 fluopyram.

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

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

Adequate enforcement methodology (German multiresidue method DFG Method S19 and GC/MSD (gas chromatography with mass-selective detection)) 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: residuemethods@epa.gov .

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 established MRLs for fluopyram in or on dry pea and lentil (0.7 ppm); the US tolerances being established in this rule for those commodities are harmonized with the Codex MRLs. Codex has not established an MRL for residues of fluopyram on cranberry.

Two comments were received in response to the notice of filing. Although it is difficult to decipher the real meaning, one comment appeared to suggest that EPA focus on enforcing proper use of the pesticide by farmers and workers rather than revising tolerance regulations. The Agency directs the commenter to the Federal Insecticide, Fungicide, and Rodenticide Act, which is the existing law that provides for enforcing appropriate use of the pesticide. This tolerance rulemaking is being undertaken under the Federal Food, Drug, and Cosmetic Act, which directs EPA to establish tolerances for residues of pesticides in or on food that it determines are safe. The Agency has assessed the safety of these tolerances and made that determination, as indicated in this rulemaking and supporting documents. The second comment to the notice of filing is not germane to this action.

The Agency is revising the commodity definition on lentils and dry peas to reflect the common commodity vocabulary currently used by the Agency. The commodity definition was revised from lentils to lentil, dry seed and dry peas to pea, dry seed. Moreover, tolerances are being established without the requested trailing zeros in accordance with the Agency's current rounding class practice.

Therefore, tolerances are established for residues of fluopyram, in or on cranberry at 2 ppm; lentil, dry seed at 0.7 ppm; and pea, dry seed at 0.7 ppm. There are currently no U.S. registrations for use of fluopyram on these commodities; these tolerances are being established to cover residues in or on these commodities that are imported into the United States.

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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0417 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 30, 2019. 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-2017-0417, 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 November 27, 2017 (82 FR 56017) (FRL-9968-5), 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 7F8582) by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide valifenalate, methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alainate, in or on bulb vegetable crop group 3-07 at 0.40 parts per million (ppm); celery at 6.0 ppm; cucurbit vegetable crop group 9 at 0.3 ppm; fruiting vegetable crop group 8-10 at 0.60 ppm; potato at 0.04 ppm; potato-chips at 0.05 ppm; potato-dried pulp at 0.06 ppm; potato-granules/flakes at 0.15 ppm; tomato, wet-peel at 1.8 ppm; and a tolerance without U.S. registration in/on grape at 3.0 ppm. After that notice of that petition was published, the petitioner made some revisions to the petition, so EPA issued another document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), in the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-27), announcing the new petition requests. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide valifenalate, methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alainate, in or on bulb vegetable crop group 3-07 at 0.40 ppm; celery at 5.0 ppm; cucurbit vegetable crop group 9 at 0.30 ppm; fruiting vegetable crop group 8-10 at 0.50 ppm; potato at 0.01 ppm; tomato, wet-peel at 0.9 ppm; and a tolerance without U.S. registration in/on grape at 5.0 ppm.

Summaries of the petition prepared by FMC Corporation, the registrant, are available in the docket, http:// www.regulations.gov. Comments were received on both notices of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from the petitioner's request in accordance with section 408(d)(4(A)(i). 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 valifenalate including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with valifenalate 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 liver and the thyroid are the main target organs for valifenalate. Following subchronic exposures to dogs, treatment-related effects in the liver were observed including alterations in liver enzyme parameters and histopathological findings as well as increased liver weights. Following chronic exposures, liver effects included increased liver weight (dog, mouse, rat) and histopathological findings (mouse and/or dog). In mice, at 78 weeks there were treatment-related liver adenomas and carcinomas in males and liver adenomas in females. Based on available data demonstrating a non-genotoxic mode of action for the liver tumors, valifenalate has been classified as “not likely to be carcinogenic to humans” at dose levels that do not cause a proliferative response in the liver.

Increases in absolute and relative thyroid weights and follicular cell hypertrophy were observed in the subchronic and chronic dog studies, in the parental animals in the two-generation reproduction study in rats and in the combined chronic toxicity/carcinogenicity study in rats (at 52 weeks). Other effects observed following chronic exposures include decreased prostate and spleen weights in males, decreased ovary weights and lack of corpora lutea in dogs, as well as an increased incidence and severity of pelvic/papillary epithelial hyperplasia in the kidney in rats.

There was no evidence of increased susceptibility to the fetus or offspring in the available developmental and reproduction toxicity studies. There were no developmental or maternal effects seen in either the rat or rabbit studies and no offspring effects were observed in the two-generation reproduction study in rats up to the limit dose of 1,000 milligram/kilogram/day (mg/kg/day). There was also no evidence of neurotoxicity in the database.

Valifenalate is categorized as having low acute lethality via oral, inhalation, and dermal routes of exposure. It is not irritating to the eyes or skin and is not a dermal sensitizer.

Specific information on the studies received and the nature of the adverse effects caused by valifenalate 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 document Valifenalate. Human Health Risk Assessment for the Section 3 Registration Action of the New Active Ingredient on Bulb Vegetables, Cucurbits, Fruiting Vegetables, Celery, and Potatoes and Establishment of a Tolerance Without U.S. Registration on Grapes in docket ID number EPA-HQ-OPP-2017-0417.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for valifenalate 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 valifenalate, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from valifenalate 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. No such effects were identified in the toxicological studies for valifenalate; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008). The chronic analysis assumed 100% crop treated, tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern (ROC) for risk assessment, HED's 2018 default processing factors, and modeled drinking water estimates.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that the chronic assessment will adequately account for all chronic toxicity, including potential carcinogenicity. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for valifenalate. Tolerance level residues or 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 valifenalate in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of valifenalate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and Pesticide Root Zone Model 5—Variable Volume Water Model (PRZM5-VVWM), the estimated drinking water concentrations (EDWCs) of valifenalate for acute exposures are estimated to be 2.6 parts per billion (ppb) for surface water and 0.05 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 2.6 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). Valifenalate is not registered for any specific use patterns that would result in residential.

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 valifenalate to share a common mechanism of toxicity with any other substances, and valifenalate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that valifenalate 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 website at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. There was no evidence of increased quantitative or qualitative susceptibility in the developmental toxicity studies in rabbits or rats or the reproduction toxicity study in rats.

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 valifenalate is complete.

ii. There is no indication that valifenalate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that valifenalate results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats 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-level residues and upper bound drinking water residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to valifenalate in drinking water. These assessments will not underestimate the exposure and risks posed by valifenalate.

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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, valifenalate is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to valifenalate from food and water will utilize 8.6% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for valifenalate.

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). A short-term adverse effect was identified; however, valifenalate is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-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 short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for valifenalate.

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, valifenalate 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 valifenalate.

5. Aggregate cancer risk for U.S. population. EPA concludes that aggregate cancer risk for valifenalate has been accounted for the chronic risk assessment, which does not present a risk of concern. Therefore, EPA concludes that aggregate exposure to valifenalate does not pose a 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 valifenalate residues.

Adequate enforcement methodology (liquid chromotography with tandem mass spectrometry (LC/MS/MS)) is available to enforce the tolerance expression.

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

The Codex has not established MRLs for valifenalate in or on the relevant commodities.

The EPA received several comments during the two 30-day comment periods following the publication of the two notices of filing. All the comments were anonymous public comments. Four comments raised issues related to pesticides, while the remainder raised issues unrelated to pesticides, and thus unrelated to this rulemaking. Of the four comments related to pesticides, one expressed concern about farmworker health, which is not an issue relevant to the assessment of the safety of the tolerances under the FFDCA. The three remaining comments expressed general concern about the potential of pesticide residues in food, although none provided any substantive information to take into consideration in EPA's safety assessment. The FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action; commenters provided no information relevant to that conclusion.

Based on available residue data and using the OECD tolerance calculation procedure, EPA is establishing tolerance values for several commodities that vary slightly from what the petition requested. In addition, EPA has determined based on available data that the tolerance requested for tomato, wet peel is not necessary as residues will be covered by the fruiting vegetables crop group tolerance. Finally, EPA is establishing a separate tolerance for grape, raisin, and for potato, granules/flakes because the application of processing factors indicates that residues are likely to concentrate in these processed commodities of the raw agricultural commodities on which valifenalate will be used.

Therefore, tolerances are established for residues of valifenalate in or on celery at 5 ppm; grape at 5 ppm; grape, raisin at 6 ppm; potato at 0.04 ppm; potato, granules/flakes at 0.09 ppm; vegetable, bulb, group 3-07 at 0.6 ppm; vegetable, cucurbit, group 9 at 0.3 ppm; vegetable, fruiting, group 8-10 at 1 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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:

The Mining Law of 1872 allows individuals and corporations to stake (or “locate”) a claim on the deposits discovered. Historically, annual assessment work and related filings have been required by statute in order to maintain an unpatented mining claim or site. 30 U.S.C. 28-28e; 43 U.S.C. 1744(a) and (c).

Beginning in fiscal year 1993, mining claimants have been required to pay an annual fee in lieu of performing annual assessment work and making annual filings. Mining claimants locating new claims or sites must pay an initial “maintenance” fee for the assessment year in which the mining claim was located, and also pay a one-time location fee. See 30 U.S.C. 28f-28l.

This rule implements 30 U.S.C. 28j(c), which requires adjustments to the location and maintenance fees “to reflect changes in the Consumer Price Index (CPI) published by the Bureau of Labor Statistics of the Department of Labor every 5 years after August 10, 1993, or more frequently if the Secretary determines an adjustment to be reasonable.” Section 28j(c) also requires that mining claimants be provided “notice of any adjustment made under this subsection not later than July 1 of any year in which the adjustment is made,” and that any fee adjustment “shall begin to apply the first assessment year which begins after adjustment is made.”

As enacted in 1993, the one-time location fee was $25, and the annual maintenance fee was $100 per mining claim or site. In 2004, the BLM increased the amount of the location and maintenance fees to $30 and $125 respectively, based on the change in the CPI from September 1, 1993 to December 31, 2003. (69 FR 40294-40296 (July 1, 2004)). In 2009, the BLM increased the amount of the location and maintenance fees to $34 and $140, respectively, based on the change in the CPI from December 31, 2003, to December 31, 2008. (74 FR 30959). On July 27, 2012, the BLM issued a rule (77 FR 44155 (July 27, 2012)), that also amended 43 CFR 3830.21, based on a law that changed the way the maintenance fee is calculated for unpatented placer mining claims. Then in 2014, the BLM increased the amount of the location fee to $37, and increased the maintenance fee to $155 for lode mining claims or sites, and $155 for each 20 acres or portion thereof for placer mining claims, based on the change in the CPI from December 31, 2008, to December 31, 2013. (79 FR 36662).

The adjustments made in this rule are based upon the change in the CPI from December 31, 2013, to December 31, 2018, as reported by the Bureau of Labor Statistics (BLS) in the “CPI Databases” ( https://www.bls.gov/cpi/data.htm ). The particular series used for this update is the “All Urban Consumers (Current Series) (Consumer Price Index—CPI-U).” This is a change from the last adjustment to these fees, made in 2014. The BLM decided to use the CPI-U series as the basis for this update (instead of the Chain CPI for All Urban Consumers (C-CPI-U)), because the release of the CPI-U data is final and timely and because it is the more common series used by Federal agencies for this type of exercise. By contrast, using the C-CPI-U series would necessitate the use of preliminary data. See the Economic and Threshold Analysis for this rule for further explanation of this change.

The calculated change is 7.80 percent from December 31, 2013, through December 31, 2018. A calculated value for the fees was obtained by inflating the location and maintenance fees established in the 2014 rulemaking by 7.80 percent. The new location fee is $40, and the new maintenance fee is $165 per lode mining claim or site and $165 for each 20 acres or portion thereof for placer mining claims. The new location fee is based on rounding the calculated value to the nearest $1. The maintenance fee is based on rounding the calculated value to the nearest $5.

Mining claimants must pay the new location fee and maintenance fee for any mining claim or site located on or after September 1, 2019. Mining claimants must pay the new maintenance fee to maintain existing mining claims and sites beginning with the 2020 maintenance year. The maintenance fee is due on or before September 1, 2019. Under 43 CFR 3834.23(d), mining claimants who have already submitted maintenance fees for the 2020 assessment year, and those who timely pay the 2020 assessment year maintenance fee based on the fee in effect immediately before the adjustment was made, will be given an opportunity to pay the additional amount without penalty upon notice from the BLM. The BLM will also give claimants the opportunity to cure deficient maintenance and location fee payments for new claims or sites located on or after September 1, 2019, and timely received on or before December 31, 2019.

The BLM is adopting this final rule solely to adjust the location and maintenance fee amounts in section 3830.21. The BLM for good cause finds under 5 U.S.C. 553(b)(3)(B) that notice and an opportunity for public comment for this rule are unnecessary, and that this rule may properly take effect upon publication. The reason is that this rule implements a statutory requirement to adjust the location and annual maintenance fees at least every 5 years, and the last adjustment was made in 2014. The statute specifies the method of calculation of the fee adjustments and prescribes the form and manner of notice of the fee adjustment, and the BLM has no discretion in implementing the statute. The BLM also determines under 5 U.S.C. 553(d) that there is good cause to place the rule into effect on the date of publication, because the adjustments made in the rule are explicitly authorized by statute.

This final rule contains only the specific amendments necessary to conform to the requirements of the statute. The amendments appear as modifications of the fee transaction table at 43 CFR 3830.21 to change the amount of the location and annual maintenance fees required to be paid for each lode mining claim, mill site, or tunnel site and for each 20 acres or portion thereof for a placer mining claim.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. This rule is not significant and OIRA will not formally review it because it does not meet one or more of the Executive Order 12866 criteria for significance as follows:

(a) This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The rule increases the maintenance and location fees as provided for by statute. We estimate that the rule will likely result in a small increase in transfer payments from mining claimants to the Federal government. The fee adjustment does not change the substance of current mining claim administration within the BLM. The total amount of fees to be collected, including the effects of the adjustment, is estimated to be $76 million annually, of which approximately $5.51 million will be attributable to the adjustments made in this rule.

(b) This rule will not create an inconsistency or otherwise interfere with an action taken or planned by another agency. The rule affects only the BLM's administration of its minerals program and does not change the relationships of the BLM to other agencies and their actions.

(c) This rule does not change the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.

(d) This rule does not raise novel legal or policy issues. It merely updates the maintenance and location fees that BLM assesses.

Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. This rule has been developed in a manner consistent with these requirements.

The rule would affect business entities across many industries. The BLM reviewed the potentially affected entities and determined the industries to which they identify. The BLM also evaluated the extent to which the proposed rule would affect entities that are small businesses, as defined by the Small Business Administration (SBA). See the Economic and Threshold Analysis for this rule for a discussion of SBA size standards.

The entities potentially affected by the rule locate mining claims or sites, and may be actively involved in the exploration and development of locatable minerals  1 on Federal lands. These entities are defined by the SBA as an individual, limited partnership, or small company considered being at “arm's length” from the control of any parent companies. The BLM does not have the authority to collect information concerning the number of employees, whether for companies locating mining claims or sites, or for companies actively involved in the exploration and development of locatable minerals on Federal lands. However, by reviewing U.S. Census Bureau data on entities involved in the development of locatable type minerals, we can make a reasonable conclusion about the extent to which the rule will affect small business as defined by the SBA.

Based on statistics from the U.S. Census Bureau's 2012 Economic Census, all of the potentially affected industries are overwhelmingly comprised of small businesses, as defined by the SBA. Based on this information, the rule could impact a substantial number of small entities.

In addition to determining if a substantial number of small entities are likely to be impacted by this final rule, the BLM must also determine whether the final rule is anticipated to have a significant economic impact on those small entities. The Regulatory Flexibility Act (RFA) does not define “significant.” Significance must be determined on a case-by-case basis. Significance should not be viewed in absolute terms, but should be seen as relative to the size of the business, the size of the competitor's business, and the impact the regulation has on larger competitors.

An analysis that looks at the individual financial circumstances, i.e., profit margin, for each firm within an industry would help in answering the significance question. However, such financial information on individual claimants is not available. Even assessing an individual entity's ability to pay is problematic as there is limited information on most claimants. Most entities holding mining claims or sites are either individuals or privately held companies.

At the end of Fiscal Year (FY) 2018, there were approximately 27,800 claimants holding approximately 413,000 mining claims and sites. This works out to be an average of 15 claims or sites per claimant. Assuming that the number of claims and sites, and the number of claimants who do not file a fee waiver, do not significantly change because of the rule, we estimate a total maintenance fee increase of about $5.34 million per year. This represents an average maintenance fee increase of about $192 per claimant. The actual impact on an individual claimant will depend on a number of factors, including the number of claims or sites that are actually held. However, the average number of claims and sites actually held by individuals and companies that would be considered small entities by SBA would likely be significantly less than the 15 claims or sites per claimant figure. This average claims-per-claimant figure is skewed by the large number of claims and sites held by a few large mining companies. For example, the three companies holding the most mining claims or sites at the end of FY 2018 each held over 10,000 claims or sites. All three of those companies were large multi-national corporations.

For the location fee increase, we estimate a total annual fee increase of about $172,000. Assuming 57,000 new filings per year and using the average figure of 15 claims or sites per claimant, we estimate approximately 3,800 claimants will be impacted by the change in the location fee. The average location fee increase will be approximately $45 per claimant. As with the maintenance fee increase, the actual location fee increase per claimant that classifies as a small entity by SBA will likely be significantly less than this $45 figure.

Therefore, the BLM has determined that this rule will not have a significant economic impact on a substantial number of small entities.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

Will not have an annual effect on the economy of $100 million or more. The revised regulation will not materially alter current BLM policy. The fee adjustments are authorized by statute. The total amount of fees collected, including the effects of the adjustment, is estimated to be $76 million annually, of which $5.51 million is attributable to the adjustments made in this rule.

Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

This rule will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is unnecessary.

This rule will not produce a Federal mandate of $100 million or greater in any year. It is not a “significant regulatory action” under the Unfunded Mandates Reform Act. The changes implemented in this rule do not require anything of any non-Federal governmental entity.

In accordance with Executive Order 12630, the BLM finds that the rule does not have takings implications. A takings implication assessment is not required. This rule does not substantially change BLM policy. Nothing in this rule constitutes a taking. The Federal courts have heard a number of suits challenging the imposition of the rental and maintenance fees as a taking of a right, or, alternatively, as an unconstitutional tax. The courts have upheld the fee legislation and the BLM regulations as a proper exercise of Congressional and Executive authorities.

The final rule will not have a substantial direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, the BLM has determined that the final rule does not have sufficient Federalism implications to warrant preparation of a Federalism Assessment.

In accordance with Executive Order 13175, the BLM finds that the final rule does not include policies that have Tribal implications. Because this rule does not make significant substantive changes in the regulations and does not specifically involve Indian reservation lands (which are closed to the operation of the Mining Law), the BLM finds that the rule will have no implications for Indians, Indian Tribes, and Tribal governments.

This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required.

This rule is not a significant regulatory action as defined in Section 3(f) of Executive Order 12866 and, therefore, is not a regulatory action under Executive Order 13711, per OMB issued guidance for implementing that executive order. As such, the BLM is not required to identify at least two existing regulations to be repealed, ensure that the costs of the rule are less than or equal to $0, or offset the costs of the rule by the elimination of existing costs associated with at least two prior regulations.

The BLM has complied with Executive Order 13711 and the OMB implementation guidance for that order.

In accordance with Executive Order 12988, the BLM finds that the final rule does not unduly burden the judicial system, and therefore meets the requirements of sections 3(a) and 3(b)(2) of the Order. The BLM consulted with the Department of the Interior's Office of the Solicitor during the drafting process.

The BLM has determined this final rule does not contain any information collection requirements that the Office of Management and Budget (OMB) must approve under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

This final rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because this rule is part of the routine administration of the fee legislation and is covered by a categorical exclusion. This rule will result in no new surface disturbing activities and therefore will have no effect on ecological or cultural resources. In promulgating this rule, the government is conducting routine and continuing government business of an administrative nature having limited context and intensity. Therefore, it is categorically excluded from environmental review under section 102(2)(C) of NEPA, pursuant to 43 CFR 46.205. The rule does not meet any of the extraordinary circumstances criteria for categorical exclusions listed at 43 CFR 46.215. Under Council on Environmental Quality regulations (40 CFR 1508.4) and the environmental policies and procedures of the Department, the term “categorical exclusion” means a category of actions which do not individually or cumulatively have a significant effect on the human environment and which have been found to have no such effect on procedures adopted by a Federal agency and for which, therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule is not a significant energy action. It will not have an adverse effect on energy supplies. To the extent that the rule affects the mining of energy minerals ( i.e., uranium and other fissionable metals), the rule applies only a statutory adjustment of the mining claim location and maintenance fees that the BLM has been collecting for many years. It will not significantly change financial obligations of the mining industry.

The principal author of this final rule is Elaine Guenaga in the Solid Minerals Group assisted by the Division of Regulatory Affairs, Washington Office, BLM.

For the reasons stated in the preamble, the BLM amends 43 CFR part 3830 as follows:

NMFS manages the Pacific sardine fishery in the U.S. exclusive economic zone (EEZ) off the Pacific Coast (California, Oregon, and Washington) in accordance with the Coastal Pelagic Species (CPS) Fishery Management Plan (FMP). The FMP and its implementing regulations require NMFS to set annual catch levels for the Pacific sardine fishery based on the annual specification framework and control rules in the FMP. These control rules include the harvest guideline (HG) control rule, which, in conjunction with the overfishing limit (OFL) and acceptable biological catch (ABC) rules in the FMP, are used to manage harvest levels for Pacific sardine, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq.

This final rule implements the annual catch levels and reference points for the 2019-2020 fishing year. The final rule adopts, without changes, the catch levels and restrictions that NMFS proposed in the rule published on May 28, 2019 (84 FR 24459), including the OFL and ABC that take into consideration uncertainty surrounding the current estimate of biomass for Pacific sardine in the U.S. EEZ off the U.S. Pacific Coast. The proposed rule for this action included additional background on specifications and the details of how the Pacific Fishery Management Council (Council) derived its recommended specifications for Pacific sardine. Those details are not repeated here. For additional information, please refer to the proposed rule for this action.

This final rule implements an OFL of 5,816 mt, an ABC and ACL of 4,514 mt, and allows Pacific sardine catch only for live bait, in a minor directed fishery, as incidental catch in other fisheries, or under an exempted fishing permit (EFP). Additionally, this rule implements an annual catch target (ACT) of 4,000 mt, as well as restrictions on the incidental catch of Pacific sardine by other fisheries and a trip limit that could be imposed on directed fishing for sardine as live bait.

For the first time, the estimated biomass for Pacific sardine has fallen below the 50,000-mt minimum stock size threshold (MSST) defined in the CPS FMP, which requires NMFS to initiate a process to declare the Pacific sardine stock overfished. Although NMFS has not officially determined the stock to be overfished, the Council made recommendations for the 2019-2020 Pacific sardine harvest specifications in anticipation of NMFS making such a determination in the near future. The CPS FMP previously required that when a CPS stock is overfished, live bait landings of that stock be restricted to only incidental catch up to 15 percent of total CPS on board. However, on June 10, 2019, NMFS approved Amendment 17 to the CPS FMP, which removed this pre-specified limit on fishing for live bait of a CPS stock that is overfished. Because Amendment 17 was still under Secretarial review at the April 2019 Council meeting, the Council recommended management measures for the 2019-2020 sardine fishing year that matched the status quo FMP provisions ( i.e., no directed live bait for overfished stocks and 15 percent maximum incidental limit on live bait for overfished stocks) but also stated its desire to use the provision of Amendment 17 ( i.e., allow directed live bait for overfished stocks with no predetermined limits) if it is approved. Because NMFS approved Amendment 17, directed live bait fishing for sardine will be permitted for the 2019-2020 fishing year per the Council's recommendation.

The final specifications include the following management measures and inseason accountability measures for commercial sardine harvest during the 2019-2020 fishing year:

(1) Directed live bait fishing is allowed, subject to the accountability measure specified under number 2 below.

(2) If landings by the live bait fishery reach 2,500 mt, NMFS will impose a 1-mt trip limit on retention of sardine in the live bait fishery.

(3) A 20-percent incidental per landing by weight catch allowance will be applied to other CPS primary directed commercial fisheries ( e.g., Pacific mackerel).

(4) A 2-mt per trip incidental catch allowance will apply to non-CPS fisheries.

(5) If the ACT of 4,000 mt is harvested by all fishing sectors combined, NMFS will impose a 1-mt trip limit on sardine caught as live bait, and a 1-mt trip limit on incidentally-caught sardine when caught while targeting other CPS.

All sources of catch, including any EFP set-asides, the live bait fishery, and other minimal sources of harvest, such as incidental catch in CPS and non-CPS fisheries, and minor directed fishing, will be counted against the ACL.

The NMFS West Coast Regional Administrator will publish a notice in the Federal Register to announce when catch reaches the incidental limits as well as any changes to allowable incidental catch percentages. Additionally, to ensure that the regulated community is informed of any closure, NMFS will make announcements through other means, including emails to fishermen, processors, and state fishery management agencies.

As explained in the proposed rule, the Quinault Indian Nation did not request a tribal set-aside for the 2019-2020 fishing year and therefore no set-aside was established and none is accounted for under the ACL.

At the April 2019 meeting, the Council also voted in support of two EFP proposals that would exempt the permit holders from the prohibition on direct harvest of Pacific sardine. The ACT and ACL were formulated with the assumption that up to 405 mt of Pacific sardine would be harvested under these two EFPs.

On May 28, 2019, NMFS published a proposed rule for this action and solicited public comments (84 FR 24459) through June 12, 2018. NMFS received two public comment letters—one from the CPS industry group California Wetfish Producers Association (CWPA), and one from the environmental advocacy organization Oceana. Both comment letters included multiple comments, including some comments that were beyond the scope of this rulemaking. After considering both public comments, no changes were made from the proposed rule. NMFS summarizes and responds to the comment letters below.

Comment 1: The CWPA stated that it disagrees with the determination made for this rule by the Chief Counsel for Regulation of the Department of Commerce under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., which concluded that the 2019-2020 proposed harvest specifications and management measures would not have a significant economic impact on a substantial number of small entities. The commenter's primary objection to the determination is that the proposed action would significantly reduce profit for a substantial number of small entities, and specifically that the proposed 20-percent incidental landing allowance of Pacific sardine in other CPS directed fisheries would have a significant impact on the affected entities.

Response: As stated in the proposed rule, the annual HG is the main tool used to manage the principal commercial sardine fishery and is the harvest level NMFS typically uses for profitability analysis. For the purposes of profitability analysis, this final rule implements an HG of zero for the 2019-2020 Pacific sardine fishing season (July 1, 2019, through June 30, 2020). Likewise, the HG for the previous 3 fishing years was also set at zero, thereby prohibiting the primary commercial directed Pacific sardine fishery. Therefore, NMFS determined that this rule will not change the potential profitability compared to recent fishing years for the primary commercial fishery for Pacific sardine.

In addition to the primary commercial fishery, NMFS recognized that this action also affects other fisheries for Pacific sardine such as live bait and minor directed fisheries, as well as other CPS fisheries that incidentally catch Pacific sardine. NMFS also determined that the proposed action will not significantly reduce the profitability of those fisheries compared to previous years. Specifically, the various directed and incidental catch allowances, such as the maximum allowed incidental catch rate of 20 percent, and other inseason management measures in this rule, are intended to not only help prevent overfishing but also ensure, to the extent practicable, maximum access to Pacific sardine throughout the fishing year for these other fishery sectors.

Regarding the commenter's objection to setting the incidental landing allowance at 20 percent, NMFS notes that the FMP requires that the incidental catch allowance for an overfished CPS stock be set between 0 and 20 percent of the landed weight of the target stock. Therefore, the incidental catch allowances for other CPS fisheries cannot be higher than 20 percent. According to the CPS FMP, Pacific sardine is in an overfished condition when its biomass is below 50,000 mt. The 2019 Pacific sardine stock assessment, which has been determined to be the best scientific information available for setting the 2019-2020 harvest specifications, shows that Pacific sardine biomass is below this level. Although NMFS has not officially determined the stock to be overfished, the Council recognized that NMFS would likely declare the stock overfished in the upcoming several months, and accordingly recommended an incidental allowance limit within this 0 to 20 percent range during the April meeting when the Council makes decisions about annual Pacific sardine specifications for the season that starts the following July. The only alternative to the 20-percent incidental allowance would have been a lower incidental allowance. For this reason, implementing a 20-percent incidental allowance has the lowest possible economic impact on small entities permitted under the CPS FMP.

Fishery information from recent years suggests that a 20-percent incidental landing limit will not unnecessarily constrain other CPS fisheries that encounter Pacific sardine. In the previous years when the commercial directed Pacific sardine fishery was closed, the maximum incidental harvest limit of Pacific sardine in other CPS fisheries was set initially at 40 percent, and then set to be reduced when the year's cumulative landings hit a certain level. For example, for the 2018-2019 Pacific sardine fishing year, incidental harvest allocation for Pacific sardine in other CPS fisheries was set at 40 percent by weight until 2,500 mt were caught, after which the limit would be reduced to 20 percent. Similarly for the 2017-2018 fishing year, 40 percent incidental sardine harvest was allowed until 2,000 mt were caught, after which it would have been reduced to 20 percent. The 2017-2018 fishing year also had a provision to further reduce incidental sardine harvest to 10 percent if total catch reached 5,000 mt. NMFS considered the reduction in the Pacific sardine incidental allowances for the 2019-2020 fishing year and potential impact for CPS fisheries that incidentally catch this stock in the RFA determination for this action. During the 2017-2018 and 2018-2019 fishing years, while operating with a 40-percent incidental trip limit, the other CPS fisheries only incidentally caught 275 mt and 174 mt (as of April 1, 2019) of Pacific sardine, respectively. Over this same time period of the 2018-2019 Pacific sardine fishing year, the commercial anchovy fishery off of California caught approximately 11,000 mt of anchovy, leading to one of the highest annual anchovy landing levels in California in recent history. These numbers demonstrate that the anchovy fishery did not need to regularly utilize a high percentage mix of Pacific sardine when harvesting anchovy.

Although the commenter presents landings data that they state demonstrates that a lower incidental limit will constrain other CPS fisheries, based on the information above, it appears that when this data is put in the larger context of all landings per species, not just landings that had incidental catch, a 20 percent incidental may not be as restrictive as looks based on that data. For example, the commenter references data showing that four anchovy landings during the current 2018-2019 Pacific sardine fishing season had incidental Pacific sardine in amounts higher than 20 percent. However, this is only 4 out of 406 landings made by CPS fishermen targeting anchovy that had any incidental Pacific sardine landings greater than 20 percent. Similarly, for the Pacific mackerel fishery, only 1 landing in the 2017-2018 fishing year, and none of the 177 Pacific mackerel landings in the 2018-2019 fishing year had any Pacific sardine landings that exceeded than 20 percent. Therefore based on recent fishing practices, and recent utilization allowances for incidental Pacific sardine landings, NMFS determined that this action would not significantly affect profitability. NMFS recognizes that CPS-species mixing rates can change and fishing conditions are dynamic. To accommodate the dynamic nature of the CPS fisheries, NMFS has supported Council recommendations over the last few years that have allowed access to the applicable Pacific sardine ACLs by other CPS fisheries that have available quota, including the maximum 40-percent incidental harvest limit during the last 2 years and the maximum 20-percent incidental harvest limit this year.

Comment 2: The CWPA stated that NMFS did not adequately consider the potential for significant environmental effects, including socioeconomic effects, from the proposed action, and should have conducted an environmental assessment (EA) under the National Environmental Policy Act.

Response: NMFS considered whether this action triggered any extraordinary circumstances that may require analysis in an EA or environmental impact statement (EIS). NMFS did not find that any extraordinary circumstances were triggered. In addition, NMFS determined that there were no significant adverse economic impacts caused by this action. Additionally, NMFS determined that this rule does not demonstrate any potential for adverse impacts to the marine environment because the level of allowable fishing has been analyzed within the scope of impacts considered in the EIS prepared for the original FMP and the EA prepared for Amendment 13 to the FMP. Lastly, this rule prohibits the primary commercial fishery from harvesting Pacific sardine during the upcoming fishing year to protect the Pacific sardine resource, thereby negating the potential for any significant impacts on any target or non-target species or other marine resources.

Comment 3: The CWPA comment letter stated that NMFS should disapprove this action because it is not based on the best scientific information available. The commenter's primary rationale for this is that the Pacific sardine stock assessment is inaccurate and that Pacific sardine biomass is higher than the estimate from the most recent stock assessment.

Response: NMFS determined that this action is based on the best scientific information available. This includes the 2019 Pacific sardine stock assessment, which the Council's SSC and NMFS reviewed and approved as the best scientific information available for setting Pacific sardine harvest specifications. NMFS did not identify inaccuracies in the 2019 Pacific sardine assessment. NMFS recognizes that during various reviews of the Pacific sardine assessment, the assessors and reviewers explored uncertainty in the data used in the model and the technical methods used to analyze the data ( e.g. selectivity patterns for the survey data, use of different age and length composition data, recruitment). However, the uncertainty in the data or the technical methods was not substantial enough to invalidate the determination that the assessment represents the best scientific information available for setting Pacific sardine harvest specifications.

NMFS is continually working to improve methods to estimate Pacific sardine biomass. In recent years, the commenter and other CPS industry members have stated that the Pacific sardine abundance they observe at sea is inconsistent with the results of the Pacific sardine assessment. To that end, the harvest specifications in this action were set to allow up to 405 mt of Pacific sardine to be harvested under two EFPs supporting industry-run research on Pacific sardine and other CPS. These EFPs will allow participants to assess CPS abundance in inshore areas that are too shallow for NOAA vessels to survey. NMFS is currently finalizing review and approval for this important research.

Comment 4: Oceana supported the prohibition on primary directed fishing for Pacific sardine and the reduction in the incidental catch allowance of Pacific sardine in other CPS fisheries from 40 percent to 20 percent. In addition to commenting on the proposed rule, Oceana's comment (and previous public comments by Oceana referenced in its letter) requested reconsideration of various aspects of Pacific sardine management that are not within the scope of this action. The recommendations in the comment letter include changing the start date of the fishery, revising the MSST value, and modifying various parameters in the OFL, ABC, and HG control rules. Oceana also commented on NMFS' timeline on declaring the Pacific sardine stock overfished and requested that NMFS declare that overfishing occurred on Pacific sardine in past years based on exploitation rates presented in the 2019 Pacific sardine stock assessment, specifically that overfishing occurred in 2017 and 2018 based on the combined U.S. and Mexico exploitation rate, which are also actions outside the scope of this rule.

Response: NMFS agrees with the commenter regarding the prohibition on primary directed fishing and the 20-percent incidental landing limit for Pacific sardine. Changes to the management framework of Pacific sardine and to the Pacific sardine harvest control rules are set in the CPS FMP and are beyond the scope of this rulemaking. NMFS notes that some of these changes, such as to the value for Distribution in the Pacific sardine harvest control rules and the MSST, have been previously reviewed during specific agenda items at Council meetings. However, NMFS will communicate other concerns to the PFMC for their consideration during related future management planning for the Pacific sardine stock.

Regarding the change in stock status for Pacific sardine, NMFS is still in the process of making a formal declaration on a change to the stock status of Pacific sardine to overfished, however we still expect to submit a letter to the Council regarding a change in the status of the Pacific sardine stock in the coming months.

As it relates to the comment that overfishing has occurred, it appears the commenter is confused with regard to how overfishing is determined for Pacific sardine, how ABC is calculated, and the differences between rate/fishing mortality based overfishing criteria and total catch based criteria. As stated in the preamble of the proposed rule and this final rule, Pacific sardine uses a total catch-based method to determine whether overfishing is occurring. That is why the OFL is set annually in the harvest specifications. Pacific sardine harvest specifications do not set a fishing mortality level or rate as the indicator for whether overfishing will occur. Although NMFS' Magnuson-Stevens Act National Standard 1 guidelines at 50 CFR part 600 Subpart D provide the option of defining “overfishing status” by using either a fishing mortality rate measured against a maximum fishing mortality threshold or catch in terms of numbers or weight of fish measured against an OFL, the CPS FMP defines overfishing for Pacific sardine by establishing an OFL annually. Overfishing would occur for Pacific sardine if total United States catch exceeded the OFL. As noted by the commenter this has never happened. Therefore overfishing has never occurred in this fishery.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the CPS FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness of these final harvest specifications for the 2019-2020 Pacific sardine fishing season. In accordance with the FMP, this rule was recommended by the Council at its meeting in April 2019. The contents of this rule were based on the best available information on the population status of Pacific sardine at that time. Making these final specifications effective on July 1, the first day of the fishing season, is necessary for the conservation and management of the Pacific sardine resource because last year's restrictions on harvest are not effective after June 30. The FMP requires a prohibition on directed fishing for Pacific sardine for the 2019-2020 fishing year because the sardine biomass has dropped below the 150,000-mt threshold for a primary directed commercial fishery. The purpose of this threshold in the FMP, and for prohibiting directed fishing when the biomass drops below this level, is to protect the stock when biomass is low and provide a buffer of spawning stock that is protected from fishing and can contribute to rebuilding the stock. A delay in the effectiveness of this rule for a full 30 days would result in the re-opening the directed commercial fishery on July 1.

Delaying the effective date of this rule beyond July 1 would be contrary to the public interest because it would jeopardize the sustainability of the Pacific sardine stock. Furthermore, most affected fishermen are aware that the Council recommended that directed commercial fishing be prohibited for the 2019-2020 fishing year and are fully prepared to comply with the prohibition.

This final rule is exempt from the procedures of E.O. 12866 because this action is an annual fishery management specification under the Magnuson-Stevens Act.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities for purposes of the RFA. The factual basis for the certification was published in the proposed rule and is not repeated here. NMFS received a comment regarding this certification that is summarized above in the preamble of the final rule. This comment did not cause NMFS to change its determination regarding the certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

Pursuant to Executive Order 13175, this final rule was developed after meaningful consultation and collaboration with the tribal representative on the Council who has agreed with the provisions that apply to tribal vessels.

This action does not contain a collection-of-information requirement for purposes of the Paperwork Reduction Act.