The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0877; Project Identifier AD-2020-01316-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this proposed AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Rose Len, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3604; email: rose.len@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, the FAA issued a final rule titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction, and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, that rule included Amendment 21-78, which established Special Federal Aviation Regulation No. 88 (“SFAR 88”) at 14 CFR part 21. Subsequently, SFAR 88 was amended by Amendment 21-82 (67 FR 57490, September 10, 2002; corrected at 67 FR 70809, November 26, 2002) and Amendment 21-83 (67 FR 72830, December 9, 2002; corrected at 68 FR 37735, June 25, 2003, to change “21-82” to “21-83”).

Among other actions, SFAR 88 requires certain type design ( i.e., type certificate (TC) and supplemental type certificate (STC)) holders to substantiate that their fuel tank systems can prevent ignition sources in the fuel tanks. This requirement applies to type design holders for large turbine-powered transport airplanes and for subsequent modifications to those airplanes. It requires them to perform design reviews and to develop design changes and maintenance procedures if their designs do not meet the new fuel tank safety standards. As explained in the preamble to the final rule published on May 7, 2001, the FAA intended to adopt airworthiness directives to mandate any changes found necessary to address unsafe conditions identified as a result of these reviews.

In evaluating these design reviews, the FAA has established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, combination of failures, and unacceptable (failure) experience. For all three failure criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action.

The FAA has determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosion or fire.

The FAA has received a report indicating that a certain type of fastener used in the fuel tank walls of Model 747 airplanes is insufficiently bonded to the airplane structure. Further, these fasteners do not have sufficient electrical insulation applied inside the fuel tanks to prevent arcing in the event of a lightning strike or high-powered short circuit. This condition, if not corrected, could result in a fuel tank explosion or fire.

The FAA reviewed Boeing Special Attention Service Bulletin 747-57-2327, Revision 8, dated November 13, 2020. This service information describes procedures for reconfiguring the clamps of certain wire bundles, applying sealant to certain fasteners that penetrate the fuel tank walls, and installing cushion clamps and TFE sleeves on the wire bundles of the front spars and rear spars of the wings.

The FAA also reviewed Boeing Service Bulletin 747-57-2326, Revision 1, dated January 31, 2008. This service information describes procedures for, among other actions, applying sealant to certain fasteners.

The FAA also reviewed The Boeing Company 747-400 Maintenance Planning Data (MPD) Document, Section 9, Airworthiness Limitations (AWL) and Certification Maintenance Requirements (CMRs), D621U400-9, Revision February 2020, which includes revised AWL tasks 28-AWL-33, 28-AWL-34, and 28-AWL-37; and The Boeing Company 747-100/200/300/SP/SR Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D6-13747-CMR, Revision September 2020, which includes revised AWL tasks 28-AWL-25, 28-AWL-27, and 28-AWL-28. The revised AWL tasks describe fuel airworthiness limitation items (ALIs) and critical design configuration control limitations (CDCCLs) that address fuel tank systems. These documents are distinct because they apply to different airplane models. The new AWLs include:

• An ALI (periodic inspections) of the cushion clamps and teflon sleeving installed on out-of-tank wire bundles installed on brackets that are mounted directly on the fuel tanks;

• A CDCCL for the cushion clamps and teflon sleeving installed on out-of-tank wire bundles installed on brackets that are mounted directly on the fuel tanks; and

• A CDCCL for lightning, fault current or hot short protection features.

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

AD 2007-20-01, Amendment 39-15211 (72 FR 54533, September 26, 2007) (AD 2007-20-01), requires actions in accordance with Boeing Service Bulletin 747-57-2326, dated January 4, 2007; and Boeing Service Bulletin 747-57-2327, Revision 1, dated July 10, 2006. AD 2007-20-01 applies to certain The Boeing Company Model 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SP, 747-400, 747-400D, and 747-400F series airplanes. The FAA has determined that AD 2007-20-01 did not fully address the unsafe condition for Model 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SP, 747-400, 747-400D, and 747-400F series airplanes. The service information for AD 2007-20-01 has been revised and contains additional work as described previously.

The FAA is proposing this AD because the agency evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require, for certain airplanes, reconfiguring the clamps of certain wire bundles, applying sealant to certain fasteners that penetrate the fuel tank walls, installing cushion clamps and TFE sleeves, inspecting to determine if sealant was applied to certain fasteners, and applying sealant if necessary. This proposed AD would also require, for all airplanes, revising the maintenance or inspection program, as applicable, to incorporate new, more restrictive airworthiness limitations.

Boeing Special Attention Service Bulletin 747-57-2327, Revision 8, dated November 13, 2020, specifies a compliance time of 60 months to accomplish Work Packages 13 through 20 and a compliance time of 27 months to accomplish Work Package 21. The FAA has determined that all work packages may be done within 60 months as it is not necessary to accomplish Work Package 21 prior to the other work packages. The FAA has determined that the 60-month compliance time is appropriate and will not adversely affect safety.

In The Boeing Company 747-100/200/300/SP/SR Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D6- 13747-CMR, Revision September 2020, the “Applicability” of airworthiness limitations 28-AWL-25 and 28-AWL-27 specifies “ALL” and “NOTE.” The FAA has determined that the applicability should be “Airplanes L/N 645 and on” as those limitations do not apply to airplanes having line numbers 1 through 644 inclusive. In addition, the “Applicability Note” in the Description column does not apply. This difference is specified in paragraph (h)(2) of the proposed AD.

The FAA estimates that this proposed AD affects 104 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA has determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the agency estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

The FAA estimates the following costs to do any necessary application of sealant that would be required based on the results of the proposed inspections. The agency has no way of determining the number of aircraft that might need this action:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

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

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

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2020-1022; Project Identifier AD-2020-01101-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may again revise this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this proposed AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this SNPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this SNPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this SNPRM. Submissions containing CBI should be sent to Tony Koung, Aerospace Engineer, Cabin Safety and Environmental Systems Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3985; email: tony.koung@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to The Boeing Company Model 757-200, -200CB, and -300 series airplanes. The NPRM published in the Federal Register on December 30, 2020 (85 FR 86515). The NPRM was prompted by a report indicating that the passenger service units (PSUs) and life vest panels became separated from their attachments during several survivable accident sequences. In the NPRM, the FAA proposed to require installing lanyard assemblies on the PSUs, and, for certain airplanes, on the life vest panels and video panels as applicable.

The FAA received a comment from one individual who supported the NPRM without change.

The FAA received additional comments from four commenters, including Boeing, ST Engineering Aerospace, American Airlines, and Delta Air Lines. The following presents the comments received on the NPRM and the FAA's response to each comment.

Boeing asked that Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 2, dated March 17, 2021, be added to the proposed AD (Revision 1, dated May 20, 2020, was referred to for accomplishing the actions in the NPRM). Boeing stated that Revision 2 includes airplanes having variable number NB451 and four other airplanes that have been determined to be non-Boeing passenger converted freighters with passenger/combi capability after conversion.

The FAA agrees with the commenter for the reason provided. Since the FAA issued the NPRM, Boeing issued Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 2, dated March 17, 2021. This revised service information added airplanes to the effectivity and regrouped the airplanes by moving certain airplanes to new Groups 6 and 7. The FAA has revised this proposed AD to refer to Revision 2 of the service information as the required service information and to give credit for airplanes identified in Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 1, dated May 20, 2020, on which the applicable actions have been done.

Boeing asked that the FAA revise the Discussion section of the NPRM by deleting the statement “In addition, there is no secondary means of retention (lanyards) for the PSU to the airplane structure.” Boeing stated that this is to maintain consistency with similar rulemaking for the PSU lanyards on Model 737 classic airplanes (Model 737-100, -200, -200C, -300, -400, and -500 series airplanes), and added that no similar statement exists in those ADs.

The FAA partially agrees with the commenter's assertions. There is no secondary means of retention (lanyards) for the PSU to the production airplane installation. Statements referring to a secondary means of PSU retention may be confusing because the production airplane installation does not include a secondary means of retention. Although the quoted statement does appear in other rulemaking (specifically, AD 2020-17-04, Amendment 39-21209 (85 FR 52268, August 25, 2020)), that statement is not retained in this SNPRM.

Boeing asked that the FAA remove the exception specified in paragraph (h)(2) of the proposed AD (in the NPRM). Boeing stated that Revision 2 of the service information includes airplanes having variable number NB451 and four other airplanes that have been determined to be non-Boeing passenger converted freighters with passenger/combi capability after conversion. Therefore, the exception identified in paragraph (h)(2) of the proposed AD is not necessary.

The FAA agrees with the commenter for the reasons provided. The FAA has removed the exception specified in paragraph (h)(2) of the proposed AD (in the NPRM) accordingly.

VT Mobile Aerospace Engineering (VT MAE) asked that Model 757-200 airplanes modified per VT MAE supplemental type certificates (STCs) ST03952AT and ST04242AT be exempt from compliance with the proposed AD requirements specified in Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 2, dated March 17, 2021. VT MAE stated that the passenger compartment is completely removed, including the PSUs and life vest panel, per drawing 1180120—Payloads Bulk deletions modification, as specified in the STCs.

The FAA agrees with the commenter's request for the reason provided. The FAA has added a new paragraph (h)(2) to this proposed AD to include this exception.

American Airlines (AAL) suggested that the NPRM provide clarification that the installation of the nylon coated cables is the compliance action required, since the PSU retention design and installation procedures determine the PSU drop height. AAL stated that Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 1, dated May 20, 2020, Tables 1 and 4 of paragraph 1.E., Compliance, in the “Action” column specify to “[i]nstall additional nylon coated stainless steel lanyards on each Passenger Service Unit (PSU) panel, such that in the event of a survivable accident, any detached PSU panel does not extend lower than Body Water Line (BWL) 265.7.” AAL added that the cables being installed are not adjustable, the physical installation of the cables does not adjust PSU drop height, and the “Procedures” section does not specify a height check of a dropped PSU. AAL concluded that the PSU drop height is defined by the installation design and is not adjustable. Delta Air Lines Inc. (Delta) asked that a new paragraph (h)(6) be added to the proposed AD to allow operators to deviate from the actions identified in Figure 1 of Boeing Special Attention Requirements Bulletin 757-25-0315 RB. Delta stated that the actions identified in the tables within Paragraph 3. “Compliance” and within Paragraph 5.(B) “Work Instructions—Actions Required for Compliance” include the following: “Install additional nylon coated stainless steel lanyards on each Passenger Service Unit (PSU) panel, such that in the event of a survivable accident, any detached PSU panel does not extend lower than Body Water Line (BWL) 265.7.”

The FAA provides the following clarification. The PSU panel would not fall below BWL 265.7 due to the airplane design, which does not allow it; a PSU panel that detached and fell below BWL 265.7 would cause injury to passengers. Operators can use the top of the floor panel as a reference to this fact. For Model 757 airplanes, the original Boeing design BWL is 208.6 per the airplane flight manual, and the PSU lanyard is pre-assembled. Therefore, the FAA has not changed this proposed AD in this regard.

Delta asked that the FAA add a new paragraph (h)(3) to the proposed AD stating “Passenger Service Units reidentified to P/N 417N3011-5000 series following accomplishment of Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 1, dated May 20, 2020, must also comply with AD 2007-07-02 [Amendment 39-15002 (72 FR 14400, March 28, 2007) (AD 2007-07-02)], except the new 417N3011-5000 series part number will supersede the 1000 dash number reidentification requirement of AD 2007-07-02.” Delta stated that the -5XXX dash number needs further guidance between AD 2007-07-02 and the proposed AD (in the NPRM).

The FAA agrees that there is connection between the -1000 and -5000 series part numbers; however, the FAA does not agree that it is necessary to add a new paragraph (h)(3) to this proposed AD to include this as an exception. The required actions in each AD are clear and must be complied with as required; these ADs do not need to be linked to effectively accomplish the actions. The FAA has not changed this proposed AD in this regard.

Delta asked that the proposed AD be updated to add a new paragraph (h)(4) to the exceptions allowing operators to deviate from Figure 1 of Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 1, dated May 20, 2020, and use Boeing Service Bulletin 737-25-1707, Revision 1, dated May 18, 2018, to install lanyard assemblies to the PSU panel. Delta stated that Model 737 airplanes specified in Boeing Service Bulletin 737-25-1707 share some part numbers in common for post-service bulletin PSUs specified in Boeing Special Attention Requirements Bulletin 757-25-0315 RB.

The FAA does not agree with the commenter's request. Referring to a different service bulletin that applies to a different airplane model could introduce problems in identifying the applicable information. Boeing has a specific service bulletin for each model referred to in an AD, and in some cases, for each minor model. Internal references in the service bulletin might not be appropriate for a different model ( e.g., the AMM or SRM reference for Model 757 airplanes might have a different number than that of Model 737 airplanes.) Under the provisions of paragraph (k) of this AD, the FAA will consider requests for approval of a deviation to the referenced service information if sufficient data are submitted to substantiate that the deviation would provide an acceptable level of safety. This proposed AD has not been changed in this regard.

Delta asked that a new paragraph (h)(5) be added to the proposed AD to allow for cosmetic changes made to Model 757 PSUs under the authority of 14 CFR part 121 (Owner/operator) and 14 CFR part 21 (STC) after compliance with AD 2007-07-02. Delta stated that other operators are also likely to have made similar cosmetic upgrades to PSUs in order to match the units to newer interior color schemes and furnishings. Delta added that this is also referenced in the language used in paragraph (l)(2)(ii) of AD 2012-11-09R1, Amendment 39-18221 (80 FR 44259, July 27, 2015).

The FAA does not agree with the commenter's request. The FAA does not need to approve minor cosmetic changes, such as interior color schemes, unless a flammability test is required. But further clarification is necessary regarding what type of cosmetic upgrades and modifications have been done and their affects on AD compliance. Under the provisions of paragraph (k) of this proposed AD, the FAA will consider requests for approval of an alternative method of compliance if sufficient data are submitted to substantiate that the upgrade or modification would provide an acceptable level of safety. This proposed AD has not been changed in this regard.

The FAA is proposing this AD after determining the unsafe condition described previously is likely to exist or develop in other products of the same type design. Certain changes described above expand the scope of the NPRM. As a result, it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.

The FAA reviewed Boeing Special Attention Requirements Bulletin 757-25-0315 RB, Revision 2, dated March 17, 2021. This service information specifies procedures for installing lanyard assemblies on the PSUs, life vest panels, and video panels as applicable. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

This proposed AD would require accomplishing the actions specified in the service information already described. For information on the procedures and compliance times, see this service information at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-1022.

The FAA estimates that this AD, if adopted as proposed, would affect 367 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

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

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

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0506; Project Identifier MCAI-2021-00200-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this proposed AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this SNPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this SNPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Sanjay Ralhan, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223; email sanjay.ralhan@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2013-25-11, Amendment 39-17707 (78 FR 78705, December 27, 2013) (AD 2013-25-11). AD 2013-25-11 requires actions to address an unsafe condition on all Airbus SAS Model A318-111, -112, -121, and -122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-111, -211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2013-25-11 requires repetitive inspections of the 80VU rack lower lateral fittings, upper fittings, and shelves for damage, repetitive inspections of the 80VU rack lower central support for cracking, and corrective action if necessary. AD 2013-25-11 also specifies optional terminating action for the repetitive inspections.

The FAA issued an NPRM to amend 14 CFR part 39 by adding an AD to supersede AD 2013-25-11 that would apply to all Airbus SAS Model A318-111, and -112, airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -216. -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The NPRM published in the Federal Register on June 22, 2021 (86 FR 32653) (the NPRM). The NPRM was prompted by reports of damaged lower lateral fittings of the 80VU rack, and reports of new damage on airplanes on which certain optional service information had been accomplished. The NPRM proposed to expand the applicability, remove the optional terminating action, and require new repetitive inspections.

Since the FAA issued the NPRM, new damage occurrences have been reported, and a different compliance time has been determined for certain affected parts, depending on airplane configuration.

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0172, dated July 20, 2021 (EASA AD 2021-0172) (also referred to after this as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all Airbus SAS Model A318-111, A318-112, A319-111, A319-112, A319-113, A319-114, A319-115, A319-131, A319-132, A319-133, A320-211, A320-212, A320-214, A320-215, A320-216, A320-231, A320-232, A320-233, A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231 and A321-232 airplanes. Model A320-215 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this proposed AD therefore does not include those airplanes in the applicability. EASA AD 2021-0172 supersedes EASA AD 2021-0045, dated February 16, 2021 (EASA AD 2021-0045). The FAA NPRM corresponds to EASA AD 2021-0045. You may examine the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0506.

This proposed AD was prompted by reports of damaged lower lateral fittings of the 80VU rack, and reports of new damage on airplanes on which certain optional service information had been accomplished. The FAA is proposing this AD to address damage or cracking of the 80VU fittings and supports, which could lead to possible disconnection of the cable harnesses to one or more computers, and if occurring during a critical phase of flight, could result in reduced control of the airplane. See the MCAI for additional background information.

EASA AD 2021-0172 describes procedures for repetitive special detailed inspections of the 80VU rack lower lateral fittings, lower central support, upper fittings, central post, and shelves attachments for discrepancies (including broken fittings, missing bolts, an electronics rack FIN 80VU that is in contact with structure, any bush that has migrated, burred material, and cracks), and corrective action if necessary. Corrective actions include modification, repair, and replacement. EASA AD 2021-0172 also describes procedures for reporting inspection results to Airbus.

The FAA has also reviewed Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020. Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020, describes inspections of the 80VU rack lower lateral fittings, lower central support, upper fittings, central post, and shelves attachments for discrepancies and corrective action.

The FAA has also reviewed Airbus Technical Adaptation 80827186/024/2020, Issue 1, dated September 18, 2020, which addresses discrepancies found in Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020.

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

The FAA gave the public the opportunity to participate in developing this rule. The following presents the comments received on the NPRM and the FAA's response to those comments. Air Line Pilots Association (ALPA), International, supported the NPRM.

American Airlines, Delta Air Lines, and United Airlines requested that the FAA incorporate new information into this proposed AD, because of the publication of EASA AD 2021-0172, which superseded EASA AD 2021-0045.

The FAA agrees to incorporate the new information by issuing this SNPRM and has revised this AD to refer to EASA AD 2021-0172 as the appropriate source of service information to accomplish the required actions.

United Airlines requested that the FAA allow the use of TA 80827186/024/2020, Issue 1, dated September 18, 2020, to address inspections and corrective actions done using Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020. United Airlines stated that Airbus has issued TA 80827186/024/2020, Issue 1, dated September 18, 2020, to address discrepancies in Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020, which is specified in EASA AD 2021-0045.

The FAA agrees with the request for the reasons provided by the commenter. The FAA has added paragraph (i) to the proposed AD to specify that Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020, with corrections referenced in the Airbus Technical Adaptation 80827186/024/2020, Issue 1, dated September 18, 2020, is an acceptable method of compliance for the inspections and corrective actions specified in paragraphs (1), (2), and (3) of EASA AD 2021-0172.

United Airlines requested that the FAA allow the use of Airbus Drawing (DWG) D53924082. United Airlines stated that in Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020, Config. 004, Figure ICN-A320-A-25XX1BKJ-A-FAPE3-00EOV-A-001-01, Sheet 2 of 2, detail D shows a fitting installation with a four fasteners configuration. United Airlines stated Airbus Drawing D53924082 indicates the fitting installation must have six fasteners configuration. United Airlines stated that Airbus confirmed it will update the service bulletin to show the assembly with a six fastener configuration.

The FAA acknowledges the commenter's request and notes the commenter did not submit the referenced drawing. However, the FAA has determined the Accomplishment Instructions steps in Airbus Service Bulletin A320-25-1BKJ, Revision 02, dated April 9, 2020, are correct for most airplanes. United Airlines is one operator in Config. 004 and it has a unique configuration. The FAA does not consider it appropriate to include various provisions in an AD applicable only to an operator's unique configuration of affected airplanes. If an operator with an affected airplane cannot accomplish the required actions specified in the service information, or prefers to use different service information that is specific to their design, an alternative method of compliance (AMOC) can be requested in accordance with the provisions specified in paragraph (j)(1) of this proposed AD. The FAA has confirmed with EASA that the solution for United Airlines' configuration will be included in the next revision of the service information expected to be published in the fourth quarter of 2021; therefore, once published, based on incorporation of the Ref. Publications: Section of EASA AD 2021-0172 in this proposed AD, United Airlines may use that service information without the need for an AMOC. The FAA has not changed this proposed AD in this regard.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the FAA evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Certain changes described above expand the scope of the NPRM. As a result, the FAA has determined that it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.

This proposed AD requires accomplishing the actions specified in the service information described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.

The FAA estimates that this proposed AD affects 1,528 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA estimates that it would take about 1 work-hour per product to comply with the proposed reporting requirement in this proposed AD. The average labor rate is $85 per hour. Based on these figures, the FAA estimates the cost of reporting the inspection results on U.S. operators to be $129,880, or $85 per product.

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:

According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators. The FAA does not control warranty coverage for affected operators. As a result, the FAA has included all known costs in the cost estimate.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120-0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by DEA for public inspection online at https://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) that you voluntarily submit. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to https://www.regulations.gov may include any personal identifying information (such as your name, address, etc.) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this advanced notice of proposed rulemaking is available at https://www.regulations.gov for ease of reference.

The Drug Enforcement Administration (DEA) implements and enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (CSIEA), (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to end. These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.

As mandated by the CSA, DEA establishes and maintains a closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822. The CSA authorizes the Administrator of DEA (by delegation of authority from the Attorney General) to register an applicant to manufacture, distribute or dispense controlled substances if the Administrator determines such registration is consistent with the public interest. 21 U.S.C. 823. The CSA further authorizes the Administrator to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA. 21 U.S.C. 871(b) and 958(f). Pursuant to these authorities, DEA is considering promulgating regulations regarding telepharmacy and seeks to be fully informed about the practice, industry, and state regulation of telepharmacy.

The term telepharmacy is not currently defined by the CSA or DEA regulation. Generally speaking, however, telepharmacy is considered to be the provision of pharmacist care by a remote pharmacist, through the use of telecommunications and other technologies, to a patient located at a dispensing site. Such pharmacist care may include, but is not limited to: The dispensing and distribution of prescription drugs, drug use review, patient counseling services, and drug therapy monitoring. Depending on the relevant state authority and regulations, telepharmacies may fill paper prescriptions or electronic prescriptions.

While the practice of telepharmacy varies from state to state, they generally fall within one of two categories: (i) Brick and mortar remote sites ; and (ii) self-service, automated machines. Brick and mortar remote sites are traditional, storefront businesses, physically staffed by non-pharmacist employees, e.g., pharmacy technicians, who are remotely supervised by a pharmacist located in a separate “parent” or “hub” pharmacy, via continuous and real-time computer, video, and audio links ( i.e., telecommunication connection). Depending on the state, a pharmacy technician may assist the remote pharmacist by receiving and inputting prescriptions into the pharmacy's information management system and preparing prescriptions for dispensing.

Self-service, automated machines are kiosks, resembling an Automatic Teller Machine (ATM), which contain pharmacy prescription medication/inventory, labeling equipment, and the telecommunication technology that connects the patient-user to the remote pharmacist via real-time video and audio links. Such automated machines may accept prescriptions or refill orders, store prepackaged or repackaged medications, label and dispense patient-specific prescriptions, and ultimately dispense the prescription to the patient-user.

Telepharmacy has expanded nationwide over the past two decades to address the need for pharmacy care in rural and other underserved communities, which may have a difficult time recruiting or supporting the employment of a pharmacist full-time. Despite the benefit of increased access to pharmacist care, such telepharmacies may pose a heightened risk of diversion by not having a pharmacist physically present to supervise and oversee remote sites and by not having any in-person monitoring of automated machines. As many of these telepharmacies may dispense controlled substances, DEA is considering promulgating regulations for a special or modified telepharmacy registration.

As telepharmacies utilize the internet to dispense controlled substances, they may constitute Online Pharmacies under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) and must therefore either: (1) Obtain a modified registration under 21 CFR 1301.19; or (2) meet one of the exceptions to an Online Pharmacy under 21 CFR 1300.04(h). The terms “internet” and “online pharmacy” are defined in the CSA. The internet is “collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.” 21 U.S.C. 802 (50) and 21 CFR 1300.04(g).

An online pharmacy is defined as any “person, entity, or internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the internet.” 21 U.S.C. 802 (52) and 21 CFR 1300.04(h). It is unlawful for any person or entity to operate as an online pharmacy, unless that person or entity is a DEA registered pharmacy under 21 CFR 1301.13 and DEA has approved and issued that person or entity a modified registration. 21 U.S.C. 823(f) and 21 CFR 1301.13(a). DEA may deny registration of an internet pharmacy if it determines the issuance of the necessary license modification would be inconsistent with the public interest. 21 CFR 1301.19(a). To date, there are no online pharmacies registered with DEA.

Paragraph (h) of 21 CFR 1300.04, provides ten exceptions to the definition of “online pharmacy,” eight of which come directly from the Ryan Haight Act. 21 CFR 1300.04(h)(1)-(10); 21 U.S.C. 802(52)(B). The first seven exceptions of the regulation provide exemptions for: DEA-registered manufacturers, distributors, and non-pharmacy practitioners; certain hospitals and other health care facilities associated with the United States government, and their respective agents and employees; advertisements that do not attempt to facilitate an actual transaction involving a controlled substance; and non-domestic persons, entities, or internet sites that do not facilitate the delivery, distribution, or dispensing of a controlled substance to persons in the U.S. The last three exceptions exempt pharmacies whose dispensing of controlled substances by means of the internet consists solely of: Filling or refilling prescriptions for controlled substances in schedules III-V; filling prescriptions that were electronically prescribed; and transmitting prescription information between a pharmacy and an automated dispensing system located in a long-term care facility. Telepharmacies may not use the internet to facilitate the dispensing of controlled substances unless they have been issued a modified registration under 21 CFR 1301.19 or fall within one of these exceptions.

The one exception DEA finds applicable in the context of telepharmacy is the Electronic Prescriptions of Controlled Substances (EPCS) exception. The EPCS exception provides that a DEA-registered pharmacy is not an Online Pharmacy if: “. . . [its] dispensing of controlled substances by means of the internet consists solely of filling prescriptions that were electronically prescribed in a manner authorized by [chapter II of title 21 of the CFR] and otherwise in compliance with the [Controlled Substances Act]” (emphasis added). 21 CFR 1300.04(h)(9). Pharmacies are authorized to fill electronically transmitted prescriptions for controlled substances provided that the pharmacy complies with the requirements of parts 1306 and 1311 of the regulations. 21 CFR 1306.08. Under this EPCS exception, telepharmacies are permitted to fill electronic prescriptions of controlled substances in compliance with DEA's EPCS regulations; however, they are not permitted to fill paper prescriptions of controlled substances. The EPCS exception does not, however, constitute a legal safe harbor that would excuse or cure other regulatory violations; telepharmacies must still otherwise comply with DEA regulations regarding registration, prescriptions, security, recordkeeping, and reporting.

DEA is aware that several states have authorized telepharmacy practice under their general legislative authority and through a variety of state regulatory entities, including state boards of pharmacy and state licensing commissions. While DEA has obtained some information regarding state telepharmacy regulations, it does not believe that the information it has is complete. Therefore, as discussed further below, DEA is specifically seeking information from state regulatory authorities regarding states' legislative and/or regulatory requirements for telepharmacy licensing and regulations.

DEA is soliciting information from the state regulatory authorities, national and professional associations, industry, telepharmacy vendors and servicers, and the general public so that DEA may obtain a better understanding of telepharmacy and how it is currently working. DEA seeks to promulgate requirements for telepharmacies in light of the growth of this telehealth service nationwide, particularly in how they dispense controlled substances. Commenters are encouraged to include the question number enumerated below in their response ( e.g., “I.4” or “II.20”). Although all comments are welcome, DEA is particularly interested in comments regarding the questions listed below and any other pertinent information and input on telepharmacy.

1. Please describe the organization and operation of telepharmacy practices authorized in your state. E.g., does your state permit or license both remote dispensing sites and automated machines?

2. How many telepharmacies are currently authorized or licensed in your state? Do you foresee even greater growth of telepharmacies in your state?

3. Please describe the telepharmacy licensing process in your state, including the criteria by which a licensing application is or will be approved or denied.

4. Is a patient-practitioner relationship required prior to telepharmacy services for a controlled and/or non-controlled drug product?

5. How many remote dispensing sites/automated machines can one remote pharmacist supervise at one time? If multiple remote sites, what happens when the pharmacist is needed by multiple remote dispensing sites at the same time?

6. Are there limits to how many remote pharmacists or organizations can access a dispensing site or automated machine?

7. Is there a controlled substance volume limit/restriction with telepharmacies?

8. What additional policies and procedures are required of telepharmacies that are not required of other pharmacies?

9. What additional security requirements are required of telepharmacies that are not required of other retail or community pharmacies?

10. Are there any regulatory considerations or policies regarding transfer of controlled and/or non-controlled substances to remote sites (in cases where drugs are stored at the remote site)?

11. Do remote dispensing sites or automated machines need to be at the same location as (or within a certain distance from) the remote pharmacist? Do the remote dispensing sites or automated machines need to be a certain distance from another remote dispensing site or automated machine?

12. Does the remote pharmacist need to be in the same state (board jurisdiction) as the remote sites or automated machines?

13. Are there other restrictions on where a remote site or automated machine may be located? E.g., are they only permitted at hospitals? Can an automated machine be placed outside a gas station or convenience store, or in proximity to a school? Does your state allow telepharmacy services in nursing homes, assisted living facilities, or for hospice programs?

14. Does your state allow interstate practice of telepharmacy, i.e. the practice of telepharmacy across state lines? Do out-of-state pharmacists providing telepharmacy services into your state need to register with your state board?

15. Can a remote pharmacist with an out-of-state license, who is authorized under federal law to care for patients in your state ( e.g., Department of Veterans Affairs pharmacists), serve as the pharmacist for a dispensing site or automated machine?

16. What recordkeeping and reporting requirements are there for telepharmacies?

17. Please describe the state's inspection process for telepharmacies.

18. Do the pharmacy technicians that staff remote sites need to be certified or licensed by the state? Can telepharmacies hire pharmacy technicians with criminal histories?

19. Does your state limit the type or manner of prescriptions that can be filled by the remote site or automated machine? Are they only allowed to fill non-controlled substances? Do they only fill electronic prescriptions as opposed to paper prescriptions? Are faxed prescriptions permitted?

20. Are there any specific regulations or considerations regarding prescribing and dispensing of opioid reversal agents by telepharmacy or automated machines?

21. Please provide examples of major issues associated with telepharmacy that have been reported to your state regulatory authorities?

22. Please provide any information that could be used to help DEA quantify or discuss qualitatively the potential costs and benefits of a rule that would either promote or restrict the use of telepharmacy.

23. Are the remote sites or automated machines typically owned and operated by the owner of the parent or hub pharmacy? If they do not share owners, how is recordkeeping handled?

24. How are locations selected for the remote sites or automated machines? If locations are based on the sociodemographic of a region or community, can you provide the data or information considered.

25. What additional training, if any, do you provide telepharmacy pharmacists and telepharmacy support staff?

26. With the absence of the pharmacist at the remote site and automated machine, how does the pharmacist adequately supervise and oversee telepharmacy technicians and staff?

27. If controlled substances are dispensed at your telepharmacy practice, are they stored and accounted for separately from non-controlled substances?

28. If your practice has not implemented the use of electronic prescriptions, what is preventing you from full implementation?

29. For those that have not adopted telepharmacy, what are the reasons or barriers to adopting telepharmacy?

30. How does the pharmacist make his or her final verification of the filled prescription remotely?

31. Is your remote site or automated machine registered with the DEA? If so, under what business activity?

32. If you are a remote pharmacist at a telepharmacy, how many remote sites and automated machines can you adequately supervise during the same period of time?

33. Please provide any information that could be used to help DEA quantify or discuss qualitatively the potential costs and benefits of a rule that would either promote or restrict the use of telepharmacy.

34. Please describe how telepharmacy technology and systems safeguard against diversion by the public at large, as well as by employees at remote sites and automated machines.

35. From a design standpoint, how are automated machines used in telepharmacy practices similar and dissimilar from the Automatic Dispensing Systems (ADSs) used at Long Term Care Facilities?

36. Are your telepharmacy technology and systems Health Insurance Portability and Accountability Act compliant?

37. Are your telepharmacy technology and systems accessible for individuals with disabilities, e.g., such as hearing impaired or blind persons?

38. Do you offer 24/7 surveillance of the telepharmacy remote site or automated machine?

39. Please provide any information that could be used to help DEA quantify or discuss qualitatively the potential costs and benefits of a rule that would either promote or restrict the use of telepharmacy.

This advanced notice of proposed rulemaking (ANPRM) has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review” and Executive Order 13563, “Improving Regulation and Regulatory Review.” The Office of Management and Budget has determined that this ANPRM is a significant regulatory action under Executive Order 12866, section 3(f), and accordingly this ANPRM has been reviewed by the Office of Management and Budget. However, this action does not propose or impose any requirements.

Furthermore, the requirements of the Regulatory Flexibility Act (RFA) do not apply to this action because, at this stage, it is an ANPRM and not a “rule” as defined in 5 U.S.C. 601. Following review of the comments received in response to this ANPRM, if DEA proceeds with a notice or notices of proposed rulemaking regarding this matter, DEA will conduct all relevant analyses as required by statute or Executive order.

The CMMC program is designed to enhance DIB cybersecurity to meet evolving threats and safeguard the information that supports and enables the Warfighter.

Interim Defense Federal Acquisition Regulation Supplement (DFARS) rule, Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041), effective November 30, 2020, implemented DFARS clause 252.204-7021, Contractor Compliance with the Cybersecurity Maturity Model Certification Level Requirement. This clause implemented the initial version of CMMC program, hereafter “CMMC 1.0.”

CMMC 1.0 was designed to protect FCI and CUI shared with and handled by DoD contractors and subcontractors on non-federal contractor information systems. CMMC 1.0 involved five progressively advanced levels of cybersecurity standards and required that DIB contractors undergo a certification process to demonstrate compliance with the CMMC cybersecurity standards at a given level.

In March 2021, the Department initiated an internal assessment of CMMC 1.0 implementation that was informed by more than 850 public comments in response to the interim DFARS rule. This comprehensive, programmatic assessment of CMMC engaged cybersecurity and acquisition leaders within DoD to refine policy and program implementation. This review resulted in “CMMC 2.0,” which updates the program structure and the requirements to streamline and improve implementation of the CMMC program.

The changes reflected in the CMMC 2.0 framework will be implemented through the rulemaking process. DoD will pursue rulemaking in both: (1) Title 32 of the Code of Federal Regulations (CFR); and, (2) title 48 CFR, to establish CMMC 2.0 program requirements and implement any needed changes to the CMMC program content in 48 CFR. Both rules will have public comment periods.

Publication of title 32 and title 48 CFR rules will implement DoD's requirements for the updated CMMC version 2.0, which include various modifications from CMMC 1.0.

These modifications include:

• Eliminating levels 2 and 4, and renaming the remaining three levels in CMMC 2.0 as follows:

○ Level 1 (Foundational) will remain the same as CMMC 1.0 Level 1;

○ Level 2 (Advanced) will be similar to CMMC 1.0 Level 3;

○ Level 3 (Expert) will be similar to CMMC 1.0 Level 5.

• Removing CMMC-unique practices and all maturity processes from all levels;

• For CMMC Level 1 (Foundational), allowing annual self-assessments with an annual affirmation by DIB company leadership;

• Bifurcating CMMC Level 2 (Advanced) assessment requirements:

○ Prioritized acquisitions involving CUI will require an independent third party assessment;

○ Non-prioritized acquisitions involving CUI will require an annual self-assessment and annual company affirmation;

• For CMMC Level 3 (Expert), requiring Government-led assessments.

• Developing a time-bound and enforceable Plan of Action and Milestone process; and,

• Developing a selective, time-bound waiver process, if needed and approved.

The title 32 CFR rulemaking for CMMC 2.0 will be followed by additional title 48 CFR rulemaking, as needed, to implement any needed changes to the CMMC program content in 48 CFR. DoD will work through the rulemaking processes as expeditiously as possible.

Until the CMMC 2.0 changes become effective through both the title 32 CFR and title 48 CFR rulemaking processes, the Department will suspend the CMMC Piloting efforts and will not approve inclusion of a CMMC requirement in DoD solicitations.

The CMMC 2.0 program requirements will not be mandatory until the title 32 CFR rulemaking is complete, and the CMMC program requirements have been implemented as needed into acquisition regulation through title 48 rulemaking.

On September 29, 2021, the U.S. Copyright Office issued a notice of proposed rulemaking (“NPRM”) regarding initiating proceedings before the Copyright Claims Board (“CCB”). The Office solicited public comments on a broad range of procedures governing the initial stages of a CCB proceeding, including filing the initial claim, opting out of a proceeding, and filing a response and any counterclaims.

On October 27, 2021, the Office extended the comment period in this proceeding by two weeks. In response to stakeholder requests following that extension, the Office is now further extending the deadline for the submission of initial comments to no later than 11:59 p.m. Eastern Time on November 30, 2021, and the deadline for the submission of reply comments to no later than 11:59 p.m. Eastern Time on December 15, 2021. The Office does not intend to grant further extensions in this proceeding.

The Mecklenburg County LIP was submitted to EPA on June 14, 1990, and EPA approved the plan on May 2, 1991. See 56 FR 20140. Mecklenburg County is now requesting that EPA approve changes to the LIP for, among other things, general consistency with the North Carolina SIP. 1 Mecklenburg County prepared three submittals in order to update the LIP and reflect regulatory and administrative changes that NCDAQ made to the North Carolina SIP since EPA's 1991 LIP approval. 2 The three submittals were submitted as follows: NCDAQ transmitted the October 25, 2017, submittal to EPA but later withdrew it from review through a letter dated February 15, 2019. On April 24, 2020, NCDAQ resubmitted the October 25, 2017, update to EPA and also submitted the January 21, 2016, and January 14, 2019, updates. Due to an inconsistency with public notices at the local level, these submittals were withdrawn from EPA through a letter dated February 15, 2019. Mecklenburg County corrected this error, and NCDAQ submitted the updates to EPA in a submittal dated April 24, 2020. 3 This proposed rule proposes to modify the LIP by revising, adding, and removing several rules related to the control of VOCs, including several VOC RACT rules, located in MCAPCO Article 2.0000, Air Pollution and Control Regulations and Procedures, Section 2.0900, Volatile Organic Compounds.

On April 30, 2004, EPA designated the Charlotte-Gastonia-Rock Hill, NC-SC area (hereinafter referred to as the “bi-state Charlotte Area”) as a moderate nonattainment area with respect to the 1997 8-hour ozone national ambient air quality standards (NAAQS). See 69 FR 23858. The bi-state Charlotte Area includes six full counties and one partial county in North Carolina and one partial county in South Carolina. 4 The North Carolina portion of the bi-state Charlotte Area consists of Cabarrus, Gaston, Lincoln, Mecklenburg, Rowan, and Union Counties and a portion of Iredell County which includes Davidson and Coddle Creek Townships.

As a result of this designation, North Carolina and South Carolina were required to amend their SIPs for their respective portions of the bi-state Charlotte Area to satisfy the relevant requirements of section 182 of the CAA. On July 25, 2013, EPA approved the RACT requirements for the North Carolina portion of the bi-state Charlotte Area. 5 See 78 FR 44890. Section 182(b)(2) of the CAA requires states to adopt RACT rules for all areas designated nonattainment for ozone and classified as moderate or above. The three parts of CAA section 182(b)(2) RACT requirements are: (1) RACT for sources covered by an existing Control Technique Guideline (CTG) ( i.e., a CTG issued prior to enactment of the 1990 amendments to the CAA); (2) RACT for sources covered by a post CAA 1990 amendments enactment CTG; and (3) RACT for all major sources not covered by a CTG ( i.e., non-CTG sources).

Pursuant to 40 CFR 51.165, a major source for a moderate ozone nonattainment area is a source that emits 100 tons per year or more of VOC or nitrogen oxides (NO X ). On May 9, 2013, EPA took final action to approve the North Carolina SIP revisions addressing NO X RACT, VOC RACT, and CTG requirements. See 78 FR 27065. Together, these SIP revisions established the RACT requirements for the major sources located in the North Carolina portion of the bi-state Charlotte Area. NCDAQ submitted a SIP revision on May 1, 2013, to address deficiencies with the State's VOC RACT rules as identified in EPA's May 9, 2013, conditional approval of North Carolina's VOC RACT rules. 6 See 78 FR 27065.

The April 24, 2020, submittal updates several MCAPCO rules incorporated into the LIP, removes several rules, and adds several rules to more closely align the LIP with the SIP. The January 21, 2016, changes include updates to MCAPCO Rules 2.0926, Bulk Gasoline Plants; 2.0927, Bulk Gasoline Terminals; 2.0928, Gasoline Service Stations Stage 1; and 2.0958, Work Practice for Sources of Volatile Organic Compounds. The submittal also seeks to remove MCAPCO Rules 2.0910, Alternative Compliance Schedules and 2.0929, Petroleum Refinery Sources; and add MCAPCO Rules 2.0947, Manufacture of Synthesized Pharmaceutical Products; 2.0948, VOC Emissions from Transfer Operations; and 2.0949, Storage of Miscellaneous Volatile Organic Compounds. 7

The January 21, 2016 submittal also asks EPA to reincorporate the following rules with no changes or very few minor grammatical edits into the LIP with a new effective date: MCAPCO Rules 2.0906, Circumvention; 2.0918, Can Coating; 2.0919, Coil Coating; 2.0924, Magnet Wire Coating; 2.0925, Petroleum Liquid Storage in Fixed Roof Tanks; 2.0930, Solvent Metal Cleaning; 2.0931, Cutback Asphalt; 2.0933, Petroleum Liquid Storage in External Floating Roof Tanks; 2.0937, Manufacture of Pneumatic Rubber Tires; and 2.0944, Manufacture of Polyethylene: Polypropylene and Polystyrene. 8

The April 24, 2020, SIP revision updates, removes, and adds rules in Section 2.0900, Volatile Organic Compounds. EPA is proposing to approve these changes to the LIP because they are consistent with the CAA and more closely align the LIP with the SIP. 9

The April 24, 2020, revision removes Rule 2.0910, Alternative Compliance Schedules, from the LIP because the alternative compliance schedules became obsolete. They are obsolete because Rule 2.0910 only allows alternative compliance schedules if they are submitted before January 1, 1980.

Rule 2.0910 was first adopted into the MCAPCO in 1979, was approved by EPA into the LIP on May 2, 1991 (56 FR 20140), and established requirements for alternative compliance schedules for VOC sources. The proposed removal of Rule 2.0910 from the LIP is consistent with the removal of the corresponding state rule, 15A NCAC 02D .0910, Alternative Compliance Schedules, from the SIP on October 15, 1999. See 64 FR 55831. EPA approved North Carolina's March 19, 1997, SIP submittal seeking removal of Rule 02D .0910 because the alternative compliance schedules had become obsolete.

EPA is proposing to approve the removal of Rule 2.0910 because the alternate compliance schedules are obsolete, it better aligns the LIP with the SIP, and it will not interfere with any applicable CAA requirements.

The April 24, 2020, revision modifies Rule 2.0926, Bulk Gasoline Plants, by adding a definition for “Average daily throughput;” adding “Incoming vapor balance system,” and “Outgoing vapor balance system” to replace and clarify the definition for “Vapor balance system;” removing paragraph (c) and redistributing its components into paragraphs (b) and (d); clarifying language in a new paragraph (c); adding language to require outgoing vapor balance systems on certain receiving truck tanks and trailers at certain bulk gasoline plants and in nonattainment areas; making a few grammatical edits including renumbering and changing “immediately” to “automatically and immediately” in paragraph (i); requiring that gasoline storage tanks be painted white or silver; requiring pressure relief valves on stationary storage tanks to be set at 0.5 psi for storage tanks placed in service on or after November 1, 1992, and 0.25 psi for storage tanks existing before November 1, 1992; requiring transfer of gasoline to be discontinued if liquid or vapor leaks are observed; and requiring truck tank and trailers to be certified leak tight in accordance with Rule 2.0932. The changes more closely align the rule with the corresponding SIP-approved state rule at 15A NCAC 02D .0926, Bulk Gasoline Plants, which reflects EPA's Bulk Gasoline Plants CTG.

Rule 2.0926 was first approved by EPA into the LIP on May 2, 1991 (56 FR 20140), was revised on June 23, 1994 (59 FR 32362), and established requirements to meet the 1977 CTG for controlling VOC emissions from bulk gasoline plants. EPA most recently approved amendments to the state rule in North Carolina's SIP, including updates that correspond to those proposed for incorporation into the LIP-approved version of Rule 2.0926, on August 1, 1997. See 62 FR 41277.

EPA is proposing to approve the changes to Rule 2.0926 because they add and clarify necessary definitions, require outgoing vapor balance systems, set required pressures for pressure relief valves and address leaks to be consistent with EPA's CTG, better align the LIP with the SIP, and will not interfere with any applicable CAA requirements.

The April 24, 2020, revision modifies Rule 2.0927, Bulk Gasoline Terminals, by adding definitions for “Degassing,” “Leak,” “Liquid balancing,” and “Liquid displacement;” making a few grammatical edits including renumbering; and adding requirements for collecting, controlling, inspecting for leaks and documenting emissions from external and internal floating roof tanks at a bulk gasoline terminal, citing Rule 2.0903. The changes more closely align the rule with the corresponding SIP-approved state rule at 15A NCAC 02D .0927, Bulk Gasoline Terminals, which reflects EPA's Tank Truck Gasoline Loading Terminals CTG.

Rule 2.0927 was first approved by EPA into the LIP on May 2, 1991 (56 FR 20140), and established requirements to meet the 1977 CTG for controlling VOC emissions from bulk gasoline terminals. EPA most recently approved amendments to the state rule in North Carolina's SIP, including updates that correspond to those proposed for incorporation into the LIP-approved version of Rule 2.0927, on October 31, 2007. See 72 FR 61531. 10

EPA is proposing to approve the changes to Rule 2.0927 because they add details on leak inspection, recordkeeping, and requirements for leak repair; standardize procedures used at bulk gasoline terminals to locate, repair and document leaks of VOC; require routine inspections; make it easier for MCAQ to determine compliance; better align the LIP with the SIP; and will not interfere with any applicable CAA requirements.

The April 24, 2020, revision modifies Rule 2.0928, Gasoline Service Station Stage 1, by adding definitions for “Coaxial system,” “Dual point system,” “Line,” “Poppeted vapor recovery adaptor,” “Stationary storage tank,” and “Throughput;” amending the definition for “Submerged fill pipe” to clarify the distance above the bottom of the tank depending on if there is a vapor recovery adaptor or not and measurement depending on whether the pipe is cut at a slant; adding applicability to delivery vessels delivering gasoline to a gasoline dispensing facility or gasoline service station; changing an exemption for certain transfers; adding clarifying language related to submerged fill pipes; adding an exemption for certain stationary storage tanks with a capacity of not more than 2,000 gallons of gasoline and for any tanks used exclusively to test the fuel dispensing meters except for those in ozone nonattainment areas; clarifying that vapor control systems must have a vapor tight connection and delivery vessels and vapor collections systems must comply with rule 2.0932 in order for gasoline to be transferred from any delivery vessel into any stationary storage tank; clarifying requirements for the vapor control system depending on whether it is a coaxial or dual point vapor recovery system and adding additional paragraphs to further explain these clarifications; removing allowance for alternative vapor control system requirements; requiring that vent lines on tanks with Stage 1 controls shall have pressure release valves or restrictors; changing the requirement that refilled vapor-laden delivery vessels that are refilled in nonattainment areas shall be refilled only at plants meeting Rules 2.096 or 2.0927 to requiring that refilled vapor-laden delivery vessels that are refilled in North Carolina shall be refilled only at plants meeting Rules 2.096 or 2.0927; and making a few grammatical edits including renumbering. The changes more closely align the rule with the corresponding SIP-approved state rule at 15A NCAC 02D .0928, Gasoline Service Stations Stage 1, which reflects EPA's Stage 1 Vapor Control Systems CTG.

Rule 2.0928 was first approved by EPA into the LIP on May 2, 1991 (56 FR 20140) and last revised on June 23, 1994 (59 FR 32362). The rule established requirements to meet the 1975 CTG for controlling VOC emissions from gasoline service stations through the Stage 1 Vapor Recovery systems. EPA most recently approved amendments to the state rule in North Carolina's SIP, including updates that correspond to those proposed for incorporation into the LIP-approved version of Rule 2.0928, on August 1, 1997. See 62 FR 41277.

EPA is proposing to approve the changes to Rule 2.0928 because they clarify Stage 1 vapor recovery requirements, better align the LIP with the SIP, and will not interfere with any applicable CAA requirements.

The April 24, 2020, revision removes Rule 2.0929 from the LIP because there are no sources in Mecklenburg County for which the Petroleum Refinery Leaks CTG category applies.

Rule 2.0929 was first adopted into the MCAPCO in 1979, was approved by EPA into the LIP on May 2, 1991 (56 FR 20140), and was revised in the LIP on June 23, 1994 (59 FR 32362). Rule 2.0929 established requirements to meet the 1978 Petroleum Refinery Leaks CTG for controlling VOC emissions from petroleum refinery equipment. The proposed removal of Rule 2.0929 from the LIP is consistent with the removal of the corresponding state rule 15A NCAC 02D .0929, Petroleum Refinery Sources, from the SIP on August 1, 1997. See 62 FR 41277. 11

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

Each state has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS) established by the EPA for the criteria pollutants (carbon monoxide, lead, nitrogen dioxide, ozone, particulate matter, sulfur dioxide). The SIP is governed by section 110 of the Clean Air Act (CAA), and contains such elements as air pollution control regulations, emission inventories, monitoring network, attainment demonstrations, and enforcement mechanisms. The SIP is a living compilation of these elements and is revised and updated by the state over time—to remain consistent with Federal requirements and to address changing air quality conditions in the state.

Alaska establishes state air quality requirements in Alaska Administrative Code Title 18 Environmental Conservation, Chapter 50 Air Quality Control (18 AAC 50). The State then submits these provisions for EPA approval and incorporation by reference into the Alaska SIP in the Code of Federal Regulations (CFR) at 40 CFR part 52, subpart C, making the provisions federally enforceable. The Alaska SIP includes a variety of air pollution control measures, including permitting programs designed to limit emissions from new and modified major and minor stationary sources. To ensure the permitting programs remain consistent with Federal requirements, the State adopts certain provisions of the Federal air regulations by reference as of a certain date and submits updates to the EPA for approval. Alaska also makes periodic changes to State permitting programs to improve implementation and to address changing air quality conditions in the State.

On November 10, 2020, Alaska submitted revisions to the SIP that, among other things, update the adoption by reference of certain Federal regulations as of July 1, 2019. 1 These regulations include Federal test procedures and methods, major source pre-construction permitting requirements, public notice requirements for stationary source permits, guidelines on air quality models, and specific air quality definitions used in the Alaska SIP and adopted by reference in 18 AAC 50.035, 040, 250, 311, 502, and 990.

Alaska also submitted a revision to 18 AAC 50.077 to correct the date by which the State has adopted the National Fireplace Institute Policy Handbook. This change corrects the date of adoption from November 19, 2019, to November 22, 2019, the date on which the Hearth, Patio and Barbeque Board of Governors formally adopted the National Fireplace Institute Policy Handbook in its current form. In addition, the submitted revisions update references in 18 AAC 50.015 to area designations and classifications codified in 40 CFR part 81, revised as of July 1, 2019.

We have evaluated the submitted adoption updates and propose to approve them because these routine updates are designed keep state requirements current with requirements for SIPs. Additional details on the adoption updates may be found in the submission which is placed in the docket for this action.

Alaska submitted a revision to the SIP to add a pre-approved emission limit option to the existing minor stationary source permitting program. This new option, added to 18 AAC 50.230, is available to certain diesel engine facilities comprised entirely of newer, cleaner “EPA-tiered” diesel engines. EPA-tiered diesel engines are designed and manufactured to be cleaner-burning than older, pre-tiered engines.

Under this option, Alaska establishes standard fuel limits based on engine type, capacity, and certification tier under the EPA New Source Performance Standards for Stationary Compression Ignition Internal Combustion Engines. 2 The standard fuel limits are designed to effectively limit nitrogen oxide emissions to below the nitrogen oxide minor source permitting threshold, and by adhering to the fuel limit, sources may be able to avoid more complex permitting requirements in 18 AAC 50.

The EPA has recognized that for certain classes of sources, such as fuel-burning equipment, it is possible for states to establish enforceable emission limits that serve to limit potential to emit through exclusionary rules that apply to certain source categories. 3 To be approvable, an exclusionary rule must, among other things, be technically justified, require that the owner or operator specifically apply for coverage under the rule, require the applicant to comply with the limit in the rule, and provide that a violation of the rule is a violation of the SIP. 4

Alaska's new pre-approved limit option is an exclusionary rule that allows a subject source to limit nitrogen oxide emissions by limiting the amount of diesel fuel used during the year. Alaska used updated EPA emissions factors to calculate the maximum quantity of fuel that may be burned by a specific engine type and certification tier, while staying below the 40 tons per year minor source potential to emit threshold in the Alaska SIP for nitrogen oxide emissions (18 AAC 50.502(c)(1)(B)). The submission states that the new option establishes “a diesel fuel limit corresponding to the lowest tiered engine at the facility; allowing 200,000; 300,000; 500,000; and 1,000,000 gallons of diesel fuel be consumed in any 12 consecutive months for engine tiers 1; 2; 3; and 4 respectively.” Alaska compiled these fuel limits for the pre-approved emission limit option into a new table, Table 5a, added to 18 AAC 50.230.

In addition, Alaska established specific procedures a source must follow to operate under a pre-approved limit. To qualify for coverage, a source must submit a request to the State to operate under a specific limit in Table 5a, and a source must provide information justifying they qualify for coverage under the limit. After submitting the request, a source must follow specific monitoring, recordkeeping, and reporting requirements to ensure compliance with the limit.

The first pre-approved emission limit option for limiting nitrogen oxide emissions from certain stationary diesel engines was approved by the EPA as consistent with EPA exclusionary rules on August 14, 2007 (72 FR 45378). We have reviewed the new pre-approved emission limit option submitted on November 10, 2021, and find it is consistent with EPA guidance for exclusionary rules. Therefore, we proposed to approve the revision to 18 AAC 50.230 and incorporate it by reference into the Alaska SIP.

Alaska submitted revisions to several rules to clarify permit notification to the EPA and modernize permit reporting processes (18 AAC 50.205, 230, 502 and 542). Alaska revised minor source permit procedural requirements to make clear that upon receipt of a complete minor source permit application, the Alaska Department of Environmental Conservation (ADEC) will not only notify the public and interested parties via SIP-approved procedures, but will also notify the EPA, consistent with EPA regulations at 40 CFR 51.161. In addition, Alaska revised the minor source permit regulations to encourage stationary source owners and operators to submit reports and other documents electronically to ADEC. Finally, Alaska added a requirement that permit reports and other documents be signed using state-approved digital signature procedures.

We propose to approve the electronic notification and reporting changes because they clarify SIP-approved requirements and are consistent with 40 CFR 51.161 public notice requirements for minor pre-construction permits and EPA guidance on federally enforceable state operating permit programs (54 FR 27274, June 28, 1989).

The provision at 18 AAC 50.346 sets forth and incorporates by reference conditions that are required to be in certain air permits, unless ADEC determines that emissions unit-specific or stationary source-specific conditions more adequately meet the requirements of state air quality regulations in 18 AAC 50 or, in some cases, that no comparable condition is appropriate for the stationary source or emissions unit. This provision is not currently in the SIP. In the November 10, 2020, SIP submission, Alaska made changes to this regulation and the standard conditions it incorporates by reference.

The EPA continues to believe that 18 AAC 50.346 is not appropriate for SIP approval. By its terms, the standard conditions referenced in this section are used in permits “unless the department determines that emissions unit-specific or stationary source-specific conditions more adequately meet the requirements of this chapter.” Therefore, the final decision on the extent to which such permit conditions, or modifications thereof, are included in a permit issued under the SIP is made in the context of issuing the permit. See generally 80 FR 33840, pp. 33917-33918 (June 12, 2015). After consultation with the EPA, ADEC requested to remove this rule and associated standard conditions from the submission.

The submitted revisions to the SIP add new rule language to centralize contingency measure triggers for nonattainment and maintenance areas in the state. There is only one nonattainment area in Alaska, specifically the Fairbanks North Star Borough fine particulate matter (PM 2.5 ) nonattainment area. There are also are a handful of areas that were formerly in nonattainment for carbon monoxide and coarse particulate matter (PM 10 ), but that have since been redesignated to attainment based on an approved maintenance plans that include contingency measures.

The revisions add paragraph (c) to 18 AAC 50.030 to specify that contingency measures are triggered upon (1) the effective date of an EPA finding that the area failed to attain the NAAQS by the applicable attainment date, failed to meet a quantitative milestone, failed to submit a required quantitative milestone report, or failed to meet a reasonable further progress requirement, or (2) an occurrence of a condition identified in the State Air Quality Control Plan as requiring implementation of a contingency measure. We have reviewed the centralized contingency measure provision and propose to approve it because it is consistent with title I, part D nonattainment and maintenance planning requirements and is also consistent with the EPA's implementing regulations for PM 2.5 in 40 CFR part 51, subpart Z.

The revisions to the SIP also include editorial changes to several rules to update the name of the Port of Alaska and to make consistent use of terms and fix cross-references. We propose to approve the editorial changes because they are administrative in nature and do not change the meaning of the regulations.

The EPA is proposing to approve, and incorporate by reference, the regulatory revisions to the Alaska SIP submitted on November 10, 2020, as being consistent with CAA section 110 and part C and D requirements. Upon final approval, the Alaska SIP will include the following regulations, State effective November 7, 2020:

• 18 AAC 50.015 Air Quality Designations, Classifications, and Control Regions;

• 18 AAC 50.030 State Air Quality Control Plan, except (a);

• 18 AAC 50.035 Documents, Procedures and Methods Adopted by Reference, except (a)(6), (a)(9), and (b)(4);

• 18 AAC 50.040 Federal Standards Adopted by Reference, except (a), (b), (c), (d), (e), (g), (j) and (k);

• 18 AAC 50.077 Standards for Wood-Fired Heating Devices, except (h);

• 18 AAC 50.205 Certification;

• 18 AAC 50.230 Preapproved Emission Limits;

• 18 AAC 50.250 Procedures and Criteria for Revising Air Quality Classifications;

• 18 AAC 50.311 Nonattainment Area Major Stationary Source Permits;

• 18 AAC 50.502 Minor Permits for Air Quality Protection;

• 18 AAC 50.540 Minor Permit: Application;

• 18 AAC 50.542 Minor Permit: Review and Issuance; and

• 18 AAC 50.990 Definitions.

In this document, the EPA is proposing to include in a final rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the provisions described in Section III of this preamble. The EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov and at the EPA Region 10 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the CAA, the EPA Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 proposed 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 proposed 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);

• 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 the requirements would be inconsistent with the CAA; and

• Does not provide the 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, this proposed rulemaking would not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rulemaking does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Mecklenburg County LIP was originally submitted to EPA on June 14, 1990, and EPA approved the plan on May 2, 1991. See 56 FR 20140. Mecklenburg County prepared three submittals in order to modify the LIP for, among other things, general consistency with the North Carolina SIP. 1 The three submittals were submitted to EPA as follows: NCDAQ transmitted the October 25, 2017, submittal to EPA but withdrew it from review through a letter dated February 15, 2019. On April 24, 2020, NCDAQ resubmitted the October 25, 2017, update to EPA and also submitted the January 21, 2016, and January 14, 2019, updates. Due to an inconsistency with public notice at the local level, these submittals were withdrawn from EPA through a letter dated February 15, 2019. Mecklenburg County corrected this error, and NCDAQ submitted the updates in a revision dated April 24, 2020. 2

On April 24, 2020, NCDAQ submitted to EPA changes to the MCAPCO to be incorporated into the LIP. 3 The January 14, 2019 portion of this submission includes changes to Rules 1.5102— Definition of Terms and 1.5111— General Recordkeeping, Reporting and Monitoring Requirements of MCAPCO Article 1.0000— Permitting Provisions for Air Pollution Sources, Rules and Operating Regulations for Acid Rain Sources, Title V and Toxic Air Pollutants. The January 21, 2016 portion of this submission includes changes and updates to Rule 1.5104— General Duties and Powers of the Director, With the Approval of the Board of MCAPCO Article 1.0000. These revisions are described in more detail below:

1. Rule 1.5102— Definition of Terms is revised to add several new terms and to remove several obsolete terms from Rule 1.5102. 4 5 The term “ Construction” is added and defined as the change in the method of operation or any change, including on-site fabrication, erection, installation, replacement, demolition, or modification of a source, that results in a change in emissions or affects the compliance status. Some activities excluded from the definition include clearing and grading, building access roads, and other activities. “ EPA Approves” is added and defined as the full, interim or partial approvals by EPA. “ Facility” is added and defined as all pollutant-emitting activities located on one or more contiguous or adjacent properties under common control. “ Insignificant Activities” is added and defined as activities that are insignificant due to their category, size, or production rate. “ Potential Emissions” is added and defined as “emissions of any air pollutant that would occur at the facility's maximum capacity to emit any air pollutant under its physical and operational design.” This term allows Federally enforceable limitations, placed on the facility's physical or operational capacities, to be considered as part of the facility's design, and includes air pollution control equipment, restriction on hours of operation or the type or amount of material combusted, stored, or processed. This term also includes fugitive emissions as defined at 40 CFR 70.2, however it does not include a facility's secondary emissions nor emissions from insignificant activities. “ Regulated Air Pollutant” is defined as nitrogen oxides or any volatile organic compound as defined under 40 CFR 51.100; any pollutant for which there is an ambient air quality standard as defined pursuant to 40 CFR part 50; any pollutant that is regulated pursuant to MCAPCO Regulation 2.0524— New Source Performance Standards, MCAPCO Regulation 2.1110— National Emission Standards for Hazardous Air Pollutants, MCAPCO Regulation 2.1111— Maximum Achievable Control Technology, or 40 CFR parts 60, 61, or 63; any pollutant subject to a standard promulgated pursuant to section 112 of the CAA or other requirements established pursuant to section 112 of the CAA, including section 112(g) (but only for the facility subject to section 112 (g)(2) of the CAA), section 112 (G) or (r) of the CAA and any Class I or II substance listed pursuant to section 602 of the CAA; or any toxic air pollutant listed in MCAPCO Regulation 2.1104— Toxic Air Pollutant Guidelines. Rule 1.5102 is also revised to add the following additional terms: “ Administrator,” “ Air Pollutant,” “ Allowable Emissions,” “ Applicable Requirements,” “ Applicant,” “ Application Package,” “ CFR,” “ EPA,” “ Equivalent Unadulterated Fuels,” “ Federally Enforceable” or “ Federal Enforceable,” “ Fuel Combustion Equipment,” “ Green Wood,” “ Hazardous Air Pollutant,” “ Lesser Quantity Cutoff,” “ Major Facility,” “ Modification,” “ Modified Facility,” “ New Facility,” “ Owner” or “ Operator,” “ Peak Shaving Generator,” “ Permit,” “ Permittee,” “ Plans and Specifications,” “ Responsible Official,” “ Saw Mill,” “ Title IV Source,” “ Title V Source,” “ Toxic Air Pollutants,” and “ Unadulterated Fossil Fuel.” These revisions generally correspond to the definitions in the state-approved SIP at 15A NCAC 02Q .0103 with minor exceptions. 6 Lastly, Rule 1.5102 is revised to remove the definitions of Cleaning Fires, Condensed Fumes, Dust-separating Equipment, Effective Stack Height, Low Volatile Solid Fuel, Smoke Density Measuring Device and Undesirable Level. Each of these terms are not operative in the currently approved version of the LIP because these terms do not appear elsewhere in the LIP. Therefore, their removal has no practical effect and will streamline Rule 1.5102.

2. Rule 1.5104— General Duties and Powers of the Director, With the Approval of the Board is revised to make minor changes to wording, such as removing the word “to” from the beginning of certain paragraphs throughout for uniformity, capitalizing the word “regulations” in paragraph (c), and capitalizing the first letter of each word in the paragraphs where the word “to” was removed.

Paragraph (l) adds language to clarify that the Director makes inspections of sources and conducts tests as necessary.

Finally, the word “and” is also removed at the end of paragraph (k) to allow for the addition of a new paragraph, paragraph (m), which identifies the Director's duty to require the facility to conduct tests and gather information to document compliance with emission standards and to effectuate the purpose of the Ordinance.

3. Rule 1.5111— General Recordkeeping, Reporting and Monitoring Requirements is revised to make minor edits to punctuation, changing commas to semi-colons, and changing the word “under” to “pursuant to.” Additionally, the phrase “and transportation facilities” is removed from Rule 1.5111(f) and the reporting threshold in Rule 1.5111(f) is reduced from 25 tons per year to 5 tons per year of actual emissions of nitrogen oxides or volatile organic compounds for sources that emit these pollutants.

EPA is proposing to approve the incorporation of the aforementioned revisions to the MCAPCO rules into the Mecklenburg LIP because these rules add clarity to the LIP and are consistent with the CAA and applicable regulations.

In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference MCAPCO Rules 1.5102— Definition of Terms and 1.5111— General Recordkeeping, Reporting and Monitoring Requirements, both which have an effective date of December 18, 2018; as well as Rule 1.5104— General Duties and Powers of the Director, With the Approval of the Board, with an effective date of December 15, 2015, into the Mecklenburg County portion of the North Carolina SIP. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

EPA is proposing to approve and incorporate into the Mecklenburg County LIP revisions to MCAPCO Rules 1.5102— Definition of Terms and 1.5111— General Recordkeeping, Reporting and Monitoring Requirements, effective on December 18, 2018, as well as Rule 1.5104— General Duties and Powers of the Director, With the Approval of the Board, effective on December 15, 2015. EPA is proposing to approve these changes because they are consistent with the CAA.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided they meet the criteria of the CAA. This proposed action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed 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 1356-3 (76 FR 3821, January 21, 2011);

• 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).

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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

This supplementary information section is arranged as follows:

In 2010, EPA established a revised primary, health-based 1-hour SO 2 NAAQS of 75 parts per billion (ppb) (75 FR 35520, June 22, 2010). On August 5, 2013, EPA designated the Rhinelander area as nonattainment for the 2010 SO 2 NAAQS based on air quality monitoring data for calendar years 2009-2011 (78 FR 47191). The Rhinelander area is comprised of Crescent Township, Newbold Township, Pine Lake Township, Pelican Township, and the City of Rhinelander in Oneida County. Wisconsin submitted an attainment plan for the Rhinelander area on January 22, 2016, and supplemented it on July 18, 2016, and November 29, 2016. On March 23, 2021, EPA partially approved and partially disapproved Wisconsin's Rhinelander SO 2 plan, as submitted and supplemented in 2016, for failure to comply with EPA's stack height regulations (86 FR 15418). 1 On March 29, 2021, Wisconsin submitted a permit containing a more stringent emission limit for Ahlstrom-Munksjö's Rhinelander facility (Ahlstrom-Munksjö) (formerly Expera Specialty Solutions LLC (Expera)), the main SO 2 source in the area, and supplemental information in order to remedy the plan's deficiencies specified in EPA's March 23, 2021, rulemaking. The plan includes modeling to show that compliance with emission limits results in attainment of the standard and ongoing maintenance. EPA proposed to approve Wisconsin's revised plan for bringing the Rhinelander area into attainment on July 22, 2021 (86 FR 38643), and EPA will not finalize this action until the attainment plan is approved and effective. On July 28, 2021, Wisconsin submitted a request to redesignate the Rhinelander area to attainment.

Under Clean Air Act (CAA) section 107(d)(3)(E), there are five criteria which must be met before a nonattainment area may be redesignated to attainment:

1. EPA has determined that the relevant NAAQS has been attained in the area.

2. The applicable implementation plan has been fully approved by EPA under section 110(k).

3. EPA has determined that improvement in air quality is due to permanent and enforceable reductions in emissions resulting from the SIP, Federal regulations, and other permanent and enforceable reductions.

4. EPA has fully approved a maintenance plan, including a contingency plan, for the area under section 175A of the CAA.

5. The State has met all applicable requirements for the area under section 110 and part D.

The first requirement for redesignation is to demonstrate that the NAAQS has been attained in the area. As stated in EPA's April 2014 “Guidance for 1-Hour SO 2 Nonattainment Area SIP Submissions,” there are two components needed to support an attainment determination: A review of representative air quality monitoring data and a further analysis, generally requiring air quality modeling, to demonstrate that the entire area is attaining the applicable NAAQS, based on current actual emissions or the fully implemented control strategy. Wisconsin has addressed both components.

Under EPA regulations at 40 CFR 50.17, the SO 2 NAAQS is met at an ambient air quality monitoring site when the three-year average of the annual 99th percentile of one-hour daily maximum concentrations is less than or equal to 75 ppb, as determined in accordance with appendix T of 40 CFR part 50 at all relevant monitoring sites in the subject area. Wisconsin operates one SO 2 monitoring site in the Rhinelander area: Rhinelander Tower monitor (AQS ID 55-085-0996). The Rhinelander Tower monitor site is located at 434 High Street under the Rhinelander municipal water tower. EPA has reviewed the ambient air monitoring data from the Rhinelander Tower monitor, focusing on air quality data collected from 2012 through 2020. For each of these calendar years, the data are quality-assured, certified, and recorded in EPA's Air Quality System database. 2

Tables 1 and 2 of this document show the 99th percentile results and three-year average design values, respectively, for the Rhinelander Tower monitor for 2012-2020. The Rhinelander Tower monitor design values are 69 ppb for 2016-2018, 36 ppb for 2017-2019, and 36 ppb for 2018-2020, which are all below the SO 2 NAAQS. Therefore, EPA finds that Wisconsin has demonstrated that Rhinelander's SO 2 monitor shows attainment.

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. 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:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA, which would include the SNUR requirements should these proposed rules be finalized. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20 any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after December 17, 2021 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) for chemical substances that were the subject of PMNs. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of any of these chemical substances for an activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks and, if appropriate, to regulate the significant new use before it may occur.

The docket for these proposed SNURs, identified as docket ID number EPA-HQ-OPPT-2021-0227, includes information considered by the Agency in developing these proposed SNURs.

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same significant new use notice (SNUN) requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN and before the manufacture or processing for the significant new use can commence, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four TSCA section 5(a)(2) factors listed in this unit.

The proposed rules include PMN substances that EPA has determined “not likely” to present an unreasonable risk under the conditions of use. EPA is proposing to identify other circumstances that, while not reasonably foreseen, would warrant further EPA review before manufacture or processing for such a use is commenced.

EPA is proposing significant new use and recordkeeping requirements for certain chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance that is identified in this unit as subject to this proposed rule:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Potentially Useful Information.

• CFR citation assigned in the regulatory text section of the proposed rule.

The chemicals subject to these proposed SNURs are as follows:

Chemical Name: Mixed amine salt (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a salt for polymers. Based on the estimated physical/chemical properties of the PMN substance, test data on components of the PMN substance, and comparison to analogous aliphatic amines, EPA has identified concerns for irritation, bladder effects, carcinogenicity, developmental effects, corrosion, pulmonary effects, and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No use involving an application method that generates a vapor, mist, aerosol, or dust.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of reproductive/developmental toxicity, specific target organ toxicity, and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11659.

Chemical Name: Oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-(chloromethyl)oxirane (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a creping aid for Yankee dryers to manufacture tissue and towel paper. Based on the estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous polycationic polymers, EPA has identified concerns for irritation and corrosion to eyes, lung, and skin, lung effects, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No manufacturing, processing, or use in any manner that results in inhalation exposure; and

• No release of the PMN substance resulting in surface water concentrations that exceed 20 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, specific target organ toxicity, and pulmonary effects testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11660.

Chemical Name: Formaldehyde, homopolymer, reaction products with N-propyl-1-propanamine.

CAS Number: 1374859-50-3.

Basis for action: The PMN states that the use of the PMN substance will be as a hydrogen sulfide scavenger used in controlling hydrogen sulfide in the vapor space of fuel storage, shipping vessels, and pipelines. Based on the estimated physical/chemical properties of the PMN substance, available data on the PMN substance, available data on a degradate of the PMN substance, and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation to the skin, eyes, and lungs, skin and eye corrosion, dermal sensitization, mutagenicity, carcinogenicity, systemic effects, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No use of the PMN substance other than as a hydrogen sulfide scavenger used in controlling hydrogen sulfide in the vapor space of fuel storage, shipping vessels, and pipelines; and

• No release of the PMN substance resulting in surface water concentrations that exceed 3 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of metabolism or pharmacokinetics, carcinogenicity, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11661.

Chemical Name: 2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid.

CAS Number: 40623-75-4.

Basis for action: The PMN states that the use of the PMN substance will be in the textile industry in bleaching and dyeing operations as a dispersing agent and for professional use. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for aquatic toxicity if the new chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No release of the PMN substance resulting in surface water concentrations that exceed 50 ppb.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity testing may be potentially useful to characterize the environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11662.

Chemical Name: Benzoic acid, alkyl derivs. (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a site intermediate. Based on the estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous phenols, EPA has identified concerns for lung effects (lung surfactancy), dermal sensitization, and systemic and developmental toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of sensitization, specific target organ toxicity, and reproductive toxicity (developmental effects) testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11663.

Chemical Name: Aminoalkylated imidazole (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as an intermediate for a polyurethane catalyst. Based on the estimated physical/chemical properties of the PMN substance, available data on a component of the PMN substance, and comparison to analogous aliphatic amines and pyrroles/diazoles, EPA has identified concerns for corrosion and severe irritation to the skin, eyes, lungs, and mucous membranes, neurotoxicity, systemic effects, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• Use of the PMN substance only for the confidential use described in the PMN;

• No use of the PMN substance in a consumer product; and

• No release of the PMN substance resulting in surface water concentrations that exceed 33 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin corrosion, eye damage, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11664.

Chemical Name: Fatty acids and fatty acid unsatd., reaction products with ethyleneamines and maleic anhydride (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be for industrial use in oilfields. Based on the estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous anionic surfactants, EPA has identified concerns for skin sensitization and lung effects if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11665.

Chemical Name: Aromatic anhydride polymer with bisalkylbiphenylbisamine compound with alkylamino acrylate ester (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an ionic salt of a polyamic acid for coatings, open, non-dispersive use. Based on the estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous aliphatic amines, EPA has identified concerns for acute toxicity, skin, eye, and respiratory tract irritation, dermal and respiratory sensitization, developmental toxicity, neurotoxicity, systemic toxicity, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• Use of the PMN substance only for the confidential use described in the PMN; and

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization, pulmonary effects, developmental toxicity, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11666.

Chemical Name: Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol monoacrylate-blocked (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as resin for industrial coatings. Based on the estimated physical/chemical properties of the PMN substance, comparison to analogous chemical substances, and comparison to analogous polyanionic polymers, EPA has identified concerns for irritation and sensitization (respiratory and skin), developmental toxicity, kidney toxicity, thyroid toxicity, and neurotoxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No use of the PMN substance in spray applications.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, skin sensitization, skin irritation, eye irritation, and reproductive/developmental toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11667.

Chemical Name: Polyol adduct of bisaldehyde (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component in hydraulic fracturing fluids. Based on the estimated physical/chemical properties of the PMN substance, comparison to analogous chemical substances, and comparison to analogous neutral organics, EPA has identified concerns for systemic toxicity, eye and skin irritation, and skin sensitization if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No use of the PMN substance involving an application method that generates a vapor, mist, or aerosol.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of sensitization and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11668.

Chemical Names: 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, sodium salts (generic) (P-18-165) and 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy- substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic) (P-18-166).

CAS Numbers: Not available.

Basis for action: The PMNs state that the use of the PMN substances will be as chemical intermediates. Based on the estimated physical/chemical properties of the PMN substances, comparison to structurally analogous chemical substances, and comparison to analogous polyanionic polymers and monomers, EPA has identified concerns for developmental toxicity, systemic effects, irritation to eyes, lungs, and mucous membranes, and aquatic toxicity if the new chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:

• No release of the PMN substances to water;

• No use of the PMN substances in consumer products; and

• No manufacturing, processing, or use of the PMN substances in any manner that results in inhalation exposure.

The proposed SNURs would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by these SNURs. EPA has determined that the results of reproductive (developmental) toxicity, specific target organ toxicity, skin irritation, eye irritation, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances.

CFR Citations: 40 CFR 721.11669 (P-18-165) and 40 CFR 721.11670 (P-18-166).

Chemical Name: Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxo- (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a chemical intermediate. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation to the eyes, lungs, and skin, systemic effects, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No use of the PMN substance in a consumer product;

• No release of the PMN substance to water; and

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, eye irritation, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11671.

Chemical Names: Polycyclic substituted alkane, polymer with cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction products with dialkylamine substituted alkyl amine (generic) (P-18-214); Polycyclic alkane, polymer with monocyclic amine, polycyclic epoxide ether, reaction products with dialkylamine alkyl amine (generic) (P-18-215); and Polycyclic substituted alkane, polymer with epoxide, reaction products with cyclicalkylamine and dialkylamine substituted alkyl amine (generic) (P-18-216).

CAS Numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the PMN substances will be as curing agents. Based on the estimated physical/chemical properties of the PMN substances and comparison to structurally analogous chemical substances, EPA has identified concerns for systemic toxicity, lung toxicity, and irritation if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measure:

• No spray application of the PMN substances other than by the method described in the spray analysis report submitted with the PMNs.

The proposed SNURs would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by these SNURs. EPA has determined that the results of pulmonary effects, absorption, specific target organ toxicity, skin irritation/corrosion, and eye irritation testing may be potentially useful to characterize the health effects of the PMN substances.

CFR Citations: 40 CFR 721.11672 (P-18-214), 40 CFR 721.11673 (P-18-215), and 40 CFR 721.11674 (P-18-216).

Chemical Name: Substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol and carbopolycyclic bis(substituted carbopolycycle) bisalkanol (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component of lenses used in electronic applications. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for lung effects (lung overload) if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results specific target organ toxicity and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11675.

Chemical Name: D-Glucopyranose, oligomeric, Bu glycosides, polymers with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.

CAS Number: 2139271-53-5.

Basis for action: The PMN states that the use of the PMN substance will be for liquid laundry. Based on the estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous polyanionic polymers and monomers, EPA has identified concerns for surfactant effects on the lung if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11676.

Chemical Name: Alkyl polyoxyethylene ethers, carboxymethylated (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a lubricant additive. Based on the estimated physical/chemical properties of the PMN substance, test data submitted on the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous anionic surfactants and nonionic surfactants, EPA has identified concerns for lung effects (surfactancy), dermal and eye irritation, systemic effects, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure; and

• No release of the PMN substance resulting in surface water concentrations that exceed 60 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, eye damage, specific target organ toxicity, and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11677.

Chemical Names: Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, potassium salts (generic) (P-19-148); Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-oxoacetate (1:1) reaction products, potassium salts (generic) (P-19-149); Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, sodium salts (generic) (P-19-150); and Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-oxoacetate (1:1) reaction products, sodium salts (generic) (P-19-151).

CAS Numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the PMN substances will be as fertilizer ingredients. Based on the estimated physical/chemical properties of the PMN substances, comparison to structurally analogous chemical substances, and comparison to analogous polyanionic polymers and monomers, EPA has identified concerns for systemic effects, developmental effects, and aquatic toxicity if the new chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:

• Use of the PMN substances only for the confidential uses described in the PMNs; and

• No domestic manufacture of the PMN substances.

The proposed SNURs would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by these SNURs. EPA has determined that the results of reproductive (developmental) toxicity, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances.

CFR Citations: 40 CFR 721.11678 (P-19-148), 40 CFR 721.11679 (P-19-149), 40 CFR 721.11680 (P-19-150), and 40 CFR 721.11681 (P-19-151).

Chemical Name: Alkaneic acid, dialkyl ester polymer with alkanediol, (isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a pre-polymer for polyurethane roll covers. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for respiratory and skin sensitization, carcinogenicity, thyroid effects, and respiratory effects toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No manufacture of the PMN substance to contain greater than 25% residual isocyanate by weight;

• No use of the PMN substance in a consumer product; and

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity and skin sensitization testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11682.

Chemical Names: Amides, from C8-18 and C18-unsatd. glycerides and diethylenetriamine, ethoxylated (P-19-155); Amides, from diethylenetriamine and palm kernel-oil, ethoxylated (P-19-156); and Amides, from coconut oil and diethylenetriamine, ethoxylated (P-19-157).

CAS Numbers: 2173332-72-2 (P-19-155), 2173332-69-7 (P-19-156), and 2173332-70-0 (P-19-157).

Basis for action: The PMNs state that the use of the PMN substances will be as adjuvants in agrochemical formulations. Based on the estimated physical/chemical properties of the PMN substances, submitted test data on the new chemical substances, comparison to structurally analogous chemical substances, and comparison to analogous amphoteric surfactants, EPA has identified concerns for lung effects (surfactancy), skin corrosion, skin sensitization, systemic effects, and aquatic toxicity if the new chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:

• No manufacturing or processing of the PMN substances in a manner that results in inhalation exposure;

• No release of the PMN substances resulting in surface water concentrations that exceed 2 ppb;

• Use of the PMN substances only as adjuvants for industrial herbicide agrochemical formulations; and

• No use of the PMN substances in consumer products.

The proposed SNURs would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by these SNURs. EPA has determined that the results of pulmonary effects, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances.

CFR Citations: 40 CFR 721.11683 (P-19-155), 40 CFR 721.11684 (P-19-156), and 40 CFR 721.11685 (P-19-157).

Chemical Name: Phenol-formaldehyde polymer with amino-oxirane copolymer and benzoates (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a dispersant polymer for coatings. Based on the estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous polycationic polymers, EPA has identified concerns for lung effects (surfactancy), irritation to the skin, eyes, and respiratory tract, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No use of the PMN substance in a consumer product;

• Use of the PMN substance only for the confidential use described in the PMN; and

• No use of the PMN substance in a final product formulation at concentration greater than 8%.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects, aquatic toxicity, skin irritation, eye irritation, and specific target organ toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11686.

During review of the chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified certain circumstances that raised potential risk concerns. EPA determined that deviations from the limitations identified in the submissions could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances, and therefore warranted SNURs. The SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the certain limitations in the submission.

EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants:

• To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identities of many of the chemical substances subject to this proposed rule have been claimed as confidential per 40 CFR 720.85. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

Therefore, EPA designates November 17, 2021 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

EPA recognizes that TSCA section 5 does not require developing any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known or reasonably ascertainable (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for all SNURs listed here. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use.

EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information listed in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket for this rulemaking.

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

This proposed rule would establish SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

According to the PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection activities related to this action have already been approved by OMB under the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This proposed rule does not contain any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including using automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of these SNURs would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

This proposed rule is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use.

This action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

Therefore, for the reasons stated in the preamble, EPA proposes to amend 40 CFR chapter I as follows:

This action is directed to the public in general. This action may, however, be of interest to those persons who manufacture (including import), distribute in commerce, process, use, or dispose of cosmetics. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth the facts which it is claimed establish that it is necessary to initiate the action requested. EPA is required to grant or deny the petition within 90 days of its filing. If EPA grants the petition, the Agency must promptly commence an appropriate proceeding. If EPA denies the petition, the Agency must publish its reasons for the denial in the Federal Register . A petitioner may commence a civil action in a U.S. district court seeking to compel initiation of the requested proceeding within 60 days of a denial or, if EPA does not issue a decision, within 60 days of the expiration of the 90-day period.

TSCA section 21(b)(1) requires that the petition “set forth the facts which it is claimed establish that it is necessary” to initiate the proceeding requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 implicitly incorporates the statutory standards that apply to the requested actions. Accordingly, EPA has relied on the standards in TSCA section 21 and in the provisions under which actions have been requested in evaluating this TSCA section 21 petition.

In general, to promulgate a rule under TSCA section 6(a), EPA must first determine “in accordance with section 6(b)(4)(A) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture . . . presents an unreasonable risk.” 15 U.S.C. 2605(a). TSCA section (b)(4)(A) is part of the risk evaluation process whereby EPA must determine “whether a chemical substance presents an unreasonable risk of injury to health or the environment,” and thus, whether a rule under TSCA section 6(a) is necessary. 15 U.S.C. 2605(b)(4)(A). In particular, EPA must conduct this evaluation “without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.” Id. Unless EPA establishes an exemption under TSCA section 6(g) (whereby certain unreasonable risks may be allowed to persist for a limited period) or EPA is addressing a persistent, bioaccumulative, and toxic substance as set forth in TSCA section 6(h), the standard for an adequate rule under TSCA section 6(a) is that it regulates “so that the chemical substance or mixture no longer presents” unreasonable risks under the conditions of use. 15 U.S.C. 2605(a). EPA may eliminate the unreasonable risk of a chemical substance or mixture by regulating manufacture, processing, distribution in commerce, commercial use, or disposal of the chemical substance in one or more of the manners described in TSCA section 6(a).

TSCA section 3(2) excludes from the definition of a “chemical substance” “any food, food additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.” 15 U.S.C. 2602(2) (emphases added). In addition, TSCA section 3(10) defines “mixture” as “any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.” 15 U.S.C. 2602(10).

TSCA section 26(h) requires EPA, in carrying out TSCA sections 4, 5, and 6, to make science-based decisions using “scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science,” while also taking into account other considerations, including the relevance of information and any uncertainties. 15 U.S.C. 2625(h). TSCA section 26(i) requires that decisions under TSCA sections 4, 5, and 6 be “based on the weight of scientific evidence.” 15 U.S.C. 2625(i). TSCA section 26(k) requires that EPA consider information that is reasonably available in carrying out TSCA sections 4, 5, and 6. 15 U.S.C. 2625(k).

On August 16, 2021, EPA received a TSCA section 21 petition (Ref. 1) from William D. Bush (the petitioner) that requests EPA take several actions under TSCA section 6. The petition asks EPA to determine that the “chemical mixtures contained within cosmetics present an unreasonable risk of injury to health and the environment” and seeks the issuance of a rule or order to “eliminate the hazardous chemicals used in mixtures [in cosmetics].” The petition also requests “any other prudent [methods] of toxic mixture substance control [EPA] may see due and fit.”

The petition requests that EPA determine that the “chemical mixtures contained within cosmetics present an unreasonable risk of injury to health and the environment.” With respect to actions under TSCA section 6, TSCA section 21 provides only for the submission of a petition seeking the initiation of a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6(a). In general, before promulgating a TSCA section 6(a) rule, EPA must first determine “in accordance with section 6(b)(4)(A)”—that is, through a TSCA risk evaluation—whether a chemical substance presents an unreasonable risk to health or the environment under the conditions of use. To initiate a TSCA section 6(b) risk evaluation, however, EPA generally must designate the chemical substance a high priority for risk evaluation. Prioritization of high priority substances for risk evaluation under TSCA section 6(b) and risk evaluation under TSCA section 6(b) are activities distinct from rulemaking under TSCA section 6(a). Because TSCA section 21 does not provide an avenue for petitioners to request the initiation of the prioritization process or the risk evaluation process through which EPA would determine whether “chemical mixtures contained within cosmetics” present an unreasonable risk, this Federal Register document does not address this specific request.

The petition requests that EPA “[o]rder by [r]ule that the manufacturing producers of cosmetics eliminate the hazardous chemicals used in mixtures [in cosmetics].” TSCA section 21 provides for the submission of a petition to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA sections 4, 5(e), or 5(f). As the petitioner is seeking issuance of a rule under TSCA section 6, this Federal Register document addresses this request.

The petition requests that EPA exercise “any other prudent [methods] of toxic mixture substance control” that the Agency deems “due and fit.” As a regulatory body, EPA cannot deviate from the statutory remedies established under TSCA section 21. Therefore, a solicitation for EPA to exercise “any other prudent [methods]” that the Agency deems “due and fit” does not adequately identify an objective that is executable within TSCA section 21. Therefore, this Federal Register document does not address this specific request.

To support the request for an order by rule that the manufacturing producers of cosmetics eliminate the hazardous chemicals used in mixtures in cosmetics, the petitioner offers information relating to human health impacts as a result of cosmetic application, human health and environmental impacts affected by cosmetic manufacture and import volume, and lack of cosmetic regulatory policy (Ref. 1, pp. 1-4). Of 13 points included in that discussion, seven are excerpts from an article on the toxicity of chemicals and contaminants of cosmetics (Ref. 2); these points are discussed in detail below. For the remaining six points, the petitioner paraphrases information from the article (Ref. 2), and references the authority of the U.S. Food and Drug Administration and regulatory actions taken worldwide as each relates to human health and environmental impacts from cosmetic chemicals.

Regarding the seven points attributed to the article on the toxicity of chemicals and contaminants in cosmetics, the petitioner cites various metrics associated with the manufacture and use of cosmetic products (Ref. 1, points 5, 10, 11, and 12) and the alleged environmental and human health effects resulting from exposure thereto (Ref. 1, points 1, 5, and 10).

Regarding manufacturing metrics, the petitioner highlights references from the article by stating, “[s]ince 2009, 595 cosmetic manufacturers reported using 88 chemicals, in more than 73,000 [cosmetic] products” (Ref. 1, point 5). The petitioner further states that “American women use an average of 12 personal care products that contain 168 different chemicals” and that the United States cosmetic industry since 2010 “has grown an average of 4.1 percent annually” with sales from 2016 totaling over $169 billion (Ref. 1, points 10 and 11). Lastly, the petitioner points to increased import of cosmetics from 181 different countries by highlighting “[c]osmetic imports from China increased 79 percent between FY 2011 and FY 2016” (Ref. 1, point 12).

The associated health affects statements mentioned by the petitioner include that cosmetic chemicals “have been linked to cancer, birth defects, and reproductive harm” and that “[m]any of these products are applied directly to the skin, the body's largest organ, where ingredients can be absorbed directly into the bloodstream” (Ref. 1, points 5 and 10). To expand on this point, the petitioner states “[n]ot only are these toxic chemicals entering our bodies through direct application, but excess product that is washed down the drain pollutes our waterways and drinking water, and compounds doses of hazardous chemicals in air, water, food, and other consumer products” (Ref. 1, point 1).

In addition, the petitioner includes a summary of the findings and policy section of the Pollution Prevention Act (42 U.S.C. 13101) (Ref. 1, points 14 and 15), though TSCA section 21 does not provide an avenue for recourse under such Act. The petitioner cites language from the Pollution Prevention Act which states that “pollution should be prevented or reduced at the source whenever feasible; pollution that cannot be prevented should be recycled in an environmentally safe manner, whenever feasible; pollution that cannot be prevented or recycled should be treated in an environmentally safe manner whenever feasible; and disposal or other release into the environment should be employed only as a last resort and should be conducted in an environmentally safe manner” and that “source reduction is fundamentally different and more desirable than waste management and pollution control.”

The petitioner also provides two claims: (1) “[t]oxic [c]hemicals added to and included in [c]osmetics are unreasonable;” and (2) “[c]osmetic [d]isposal presents a clear unreasonable risk to the [e]nvironment.” (Ref. 1, pp. 5-6). To support the former claim, the petitioner argues that the chemical mixtures contained in cosmetics provide no benefit to consumers considering said chemicals can “harm public welfare and the environment through their use consumption and disposal,” but does not cite or provide reference. To support the latter claim, the petitioner states that “research studies of toxic waste entering the environment are clear in identifying cosmetics as a major hazardous waste emission,” but does not cite or provide any reference to such studies.

After careful consideration, EPA has denied this TSCA section 21 petition. A copy of the Agency's response, which consists of the letter to the petitioner and this document, is posted on the EPA petition website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#cosmetics. The response, the petition (Ref. 1), and other information is available in the docket for this TSCA section 21 petition.

TSCA section 21 does provide for the submission of a petition seeking the initiation of a proceeding for the issuance of a rule under TSCA section 6(a). The petition must “set forth the facts which it is claimed establish that it is necessary to issue” the requested rule. 15 U.S.C. 2620(b)(1). When determining whether the petition meets that burden, EPA will consider whether the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or any combination of such activities, may present an unreasonable risk of injury to health or the environment.

EPA evaluated the information presented in the petition and considered that information in the context of the applicable authorities and requirements of TSCA sections 3(2), 6, 21, and 26. Notwithstanding that the burden is on the petitioner to present “the facts which it is claimed establish that it is necessary” for EPA to initiate the rule or issue the order sought, EPA nonetheless also considered relevant information that was reasonably available to the Agency during the 90-day petition review period. As detailed further in this Unit, EPA finds that the petitioner has not met its burden to support the requested actions.

Under TSCA section 6(a), EPA must, by rule, issue regulations applying one or more of the listed requirements to the extent necessary so that a chemical substance or mixture found to present unreasonable risk no longer presents such risk.-TSCA section 3(2)(B), which defines “chemical substance,” excludes “any food, food additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device” (emphases added). According to section 201(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA), “cosmetic” means “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.” 21 U.S.C. 321(i). Under TSCA, “cosmetics” are not a “chemical substance” when manufactured, processed, or distributed in commerce for use as a cosmetic. Therefore, EPA cannot issue a rule pursuant to TSCA section 6(a) to apply requirements to such cosmetics. In addition, while a “mixture” can be subject to TSCA section 6(a), because the requested action is for “hazardous chemicals used in mixtures [in cosmetics],” EPA cannot issue a rule pursuant to TSCA section 6(a) to apply requirements to cosmetics when manufactured, processed, or distributed in commerce for use as a cosmetic. To the extent the petition seeks action on “cosmetics” when manufactured, processed, or distributed in commerce as cosmetics—including direct regulation of cosmetics through an order by rule that cosmetic manufacturers eliminate hazardous chemicals used in mixtures in cosmetics or through an action to address the first claim that “[t]oxic [c]hemicals added to and included in [c]osmetics are unreasonable”—the petition does not request actions that are within EPA's jurisdiction under TSCA.

To the extent the petition seeks action on “chemical substances” within the TSCA section 3(2) definition of that term—including action to address the petitioner's second claim that “[c]osmetic [d]isposal presents a clear unreasonable risk to the [e]nvironment”—EPA finds that the petitioner did not set forth facts establishing that it is necessary to initiate an appropriate proceeding pursuant to TSCA section 21. In particular, with respect to the second claim, EPA finds that the petition did not demonstrate facts that could support an EPA determination of unreasonable risk to the environment. Rather, the specific chemical substances identified by the petition as examples are discussed by reference to their potential human health effects when used in manufactured cosmetic products. In addition, while the petition cites TSCA and Pollution Prevention Act authorities applicable to disposal, there are no data or references offered to support the assertion that “research studies of toxic waste entering the environment are clear in identifying cosmetics as a major hazardous waste emission” (Ref. 1, p. 6). As explained above, TSCA section 21(b)(1) requires that the petition “set forth the facts which it is claimed establish that it is necessary” to initiate the proceeding requested. 15 U.S.C. 2620(b)(1). TSCA section 21(b)(4)(B) also provides the standard for judicial review should EPA deny a request for rulemaking under TSCA section 6(a): “If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that . . . the chemical substance or mixture to be subject to such rule . . . presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use,” the court shall order the EPA Administrator to initiate the requested action. 15 U.S.C. 2620(b)(4)(B). Consistent with these provisions, a petition for a TSCA section 6(a) rulemaking must set forth facts which would enable EPA to conclude that there is an unreasonable risk for which a TSCA section 6(a) risk management rule is warranted. EPA does not find that the petition in this case sets forth facts which would enable EPA to conclude that the disposal of particular chemical substance(s) or mixture(s) in cosmetics presents unreasonable risk and that an appropriate proceeding should be initiated. To the extent the petition seeks other action cognizable under TSCA section 21 to address “chemical substances” in cosmetics outside of cosmetic disposal, EPA similarly finds that the petition does not set forth sufficient facts to establish the necessity of initiating an appropriate proceeding under TSCA section 21.

Finally, to the extent that the petition referenced the Pollution Prevention Act (42 U.S.C. 13101), the Agency reiterates that TSCA section 21 does not provide an avenue for recourse under such Act.

EPA denied the request to issue a rule under TSCA section 6(a). TSCA section 3(2)(B) excludes “cosmetic” from the definition of “chemical substance” when manufactured, processed, or distributed in commerce for use as a cosmetic. Therefore, cosmetics, and any combination of chemicals contained therein, are not chemical substances under TSCA when manufactured, processed, or distributed in commerce for use as a cosmetic. To the extent the petition seeks TSCA section 6 action on “cosmetics” when manufactured, processed, or distributed in commerce as cosmetics, the requested actions are not within EPA's jurisdiction under TSCA. In addition, to the extent the petition seeks action on “chemical substances” within the TSCA section 3(2) definition of that term, EPA finds that the petition did not set forth facts establishing that it is necessary to initiate an appropriate proceeding pursuant to TSCA section 21. In particular, the petition did not identify the disposal of any particular chemical substance(s) or mixture(s) that could support an EPA determination of unreasonable risk to the environment and, therefore, did not set forth sufficient facts establishing that it is necessary to issue a TSCA section 6(a) rule addressing cosmetic disposal.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

This rulemaking is issued under the authority of the Office of Federal Procurement Policy (OFPP) Act which provides the authority for an agency head to issue agency acquisition regulations that implement or supplement the FAR.

VA is proposing to revise the VAAR to add new policy or regulatory requirements, to update existing policy, and to remove any redundant guidance where it may exist in affected parts, and to place guidance that is applicable only to VA's internal operating processes or procedures in the VAAM. Codified acquisition regulations may be amended and revised only through rulemaking. All amendments, revisions, and removals have been reviewed and concurred with by VA's Integrated Product Team of agency stakeholders.

The VAAR uses the regulatory structure and arrangement of the FAR and headings and subject areas are consistent with the FAR content. The VAAR is divided into subchapters, parts (each of which covers a separate aspect of acquisition), subparts, sections, and subsections.

The Office of Federal Procurement Policy Act, as codified in 41 U.S.C. 1707, provides the authority for the Federal Acquisition Regulation and for the issuance of agency acquisition regulations consistent with the FAR.

When Federal agencies acquire supplies and services using appropriated funds, the purchase is governed by the FAR, set forth at title 48 Code of Federal Regulations (CFR), chapter 1, parts 1 through 53, and the agency regulations that implement and supplement the FAR. The VAAR is set forth at title 48 CFR, chapter 8, parts 801 through 873.

VA proposes to make the following changes to the VAAR in this phase of its revision and streamlining initiative. This rule adds a new VAAR part 839 along with proposed revisions to other parts as described below. Where necessary, procedural guidance has been considered for inclusion in VA's internal agency operating procedures in accordance with FAR 1.301(a)(2). Similarly, delegations of authorities will be included in the VA Acquisition Manual (VAAM) as internal agency guidance. These changes seek to streamline and align the VAAR with the FAR and remove outdated and duplicative requirements and reduce burden on contractors. The VAAM incorporates portions of the removed VAAR as well as other internal agency acquisition procedures. VA will rewrite certain parts of the VAAR and VAAM, and as VAAR parts are rewritten, will publish them in the Federal Register . VA will combine related topics, as appropriate. The VAAM is being created in parallel with these revisions to the VAAR and is not subject to the rulemaking process as the VAAM contains internal VA procedures and guidance. Therefore, the VAAM will not be finalized and available online for any new parts until corresponding VAAR parts are finalized.

VA proposes to add the following 11 definitions in section 802.101 to reflect terms VA uses in more than one part as related to the amendatory text, parts and clauses and provisions outlined in this VAAR case: Business Associate, Business Associate Agreement (BAA), Gray market items, Information system, Information technology, Information technology-related contracts, Privacy officer, Security plan, Sensitive personal information, VA Information Security Rules of Behavior for Organizational Users, and VA sensitive information.

We propose to add the following authorities to part 804:

• 38 U.S.C. 5723, which requires all users of VA information and information systems to (1) Comply with all VA security policies, procedures, and practices; (2) Take security awareness training on at least an annual basis; (3) Report all actual or suspected security and privacy incidents immediately to the Information System Security Officer (ISSO) or Privacy Officer of the facility and to their immediate supervisor (in VA contracts contractors will be required to report security incidents to the contracting officer and the contractor officer's representative (COR), as identified or directed in the contract, within one hour of discovery or suspicion); and (4) Sign and acknowledge VA's Information Security Rules of Behavior for Organizational Users ( i.e., “VA National Rules of Behavior”) on an annual basis;

• 38 U.S.C. 5724, which requires VA, in the event the Secretary determines there exists a reasonable risk for the potential misuse of sensitive personal information involved in a data breach, to provide credit protection services, as well as notification to the affected individual; and

• 38 U.S.C. 5725(a)-(c), which requires the Secretary to ensure that if a contract is entered into for the performance of any Department function that requires access to sensitive personal information include, as a condition of the contract, that a contractor shall not, directly or through an affiliate of the contractor, disclose such information to any other person unless the disclosure is lawful and is expressly permitted under the contract. This statute also requires the contractor, or any subcontractors under the contract, to promptly notify VA (within one hour of discovery or suspicion) of any actual or suspected data breach that occurs with respect to sensitive personal information. It further requires that each such contract is subject to liquidated damages to be paid by the contractor to VA in the event of a data breach of any sensitive personal information processed or maintained by the contractor or any subcontractor under the contract. Such liquidated damages will be used for the purpose of VA providing credit protection services.

VA proposes to amend part 804 by adding subpart 804.19, Basic Safeguarding of Covered Contractor Information Systems, and sections 804.1900-70, Scope of subpart; 804.1902, Applicability; 804.1970, Information security policy—contractor general responsibilities; and 804.1903, Contract clause.

In section 804.1900-70, Scope of subpart, it would state that the subpart prescribes policies and procedures for information security and protection of VA information, information systems, and VA sensitive information, including sensitive personal information.

In section 804.1902, Applicability, VA stipulates that the subpart would apply to all VA acquisitions, including acquisitions of commercial items other than commercially available off-the-shelf items, when a contractor's information system may contain VA information.

In section 804.1970, Information security policy—contractor general responsibilities, VA provides policy requiring contractors, subcontractors, business associates and their employees who are users of VA information or information systems, or have access to VA information and VA sensitive information to—

• Comply with all VA information security program policies, procedures, practices and related contract requirements, specifications and clauses;

• Complete VA security awareness training on an annual basis;

• Complete VHA's Privacy and Health Insurance Portability and Accountability Act of 1996 (HIPAA) Training on an annual basis when access to protected health information (PHI) is required;

• Report all actual or suspected security/privacy incidents and reporting information to the contracting officer, and COR as identified or as directed in the contract, within one hour of discovery or suspicion;

• Comply with VA policy as it relates to personnel security and suitability program requirements for background screening of both employees and non-employees who have access to VA information systems and data;

• Comply with directions that may be issued by the contracting officer or COR, or from the VA Assistant Secretary for Information and Technology or a designated representative through the contracting officer or COR, directing specific activities when a security/privacy incident occurs;

• Sign an acknowledgment that they have read, understand, and agree to abide by the VA Information Security Rules of Behavior for Organizational Users (VA National Rules of Behavior) as required by 38 U.S.C. 5723, FAR 39.105, Privacy, and clause 852.204-71, Information and Information Systems Security, on an annual basis. The VA Information Security Rules of Behavior describe the responsibilities and expected behavior of contractors, subcontractors, business associates and their employees who are users of VA information or information systems, information assets and resources, or have access to VA information;

• Maintain records and compliance reports regarding HIPAA Security and Privacy Rule compliance in order to provide such information to VA upon request to ascertain whether the business associate is complying with all applicable provisions under both rules' regulatory requirements; and

• Flow down requirements in all subcontracts and Business Associate Agreements (BAAs), at any level, as provided in the clause at 852.204-71, Information and Information Systems Security.

Section 804.1903, Contract clause, would require contracting officers to insert clause 852.204-71, Information and Information Systems Security, as further described in VAAR part 852 below in the preamble, when FAR clause 52.204-1, Basic Safeguarding of Covered Contractor Information Systems is required to be included in accordance with FAR 4.1903.

We propose to add the following authorities to supplement the existing authorities for the proposed policies and procedures under part 811 as follows:

• 38 U.S.C. 5723, which requires all users of VA information and information systems to (1) Comply with all VA security policies, procedures, and practices; (2) Take security awareness training on at least an annual basis; (3) Report all actual or suspected security and privacy incidents and report the information to the appropriate Information System Security Officer (ISSO) or Privacy Officer of the facility and to their immediate supervisor (in VA contracts contractors will be required to report security incidents to the contracting officer and the contractor officer's representative (COR), as identified or directed in the contract, within one hour of discovery or suspicion); and (4) Sign and acknowledge VA's Information Security Rules of Behavior for Organizational Users ( i.e., VA National Rules of Behavior) on an annual basis.

• 38 U.S.C. 5724, which requires VA, in the event the Secretary determines there exists a reasonable risk for the potential misuse of sensitive personal information involved in a data breach, to provide credit protection services, as well as notification to the affected individual.

• 38 U.S.C. 5725(a)-(c), which requires the Secretary to ensure that if a contract is entered into for the performance of any Department function that requires access to sensitive personal information include, as a condition of the contract, that a contractor shall not, directly or through an affiliate of the contractor, disclose such information to any other person unless the disclosure is lawful and is expressly permitted under the contract. This statute also requires the contractor, or any subcontractors under the contract, to promptly notify VA (within one hour of discovery or suspicion) of any actual or suspected data breach that occurs with respect to sensitive personal information. It further requires that each such contract is subject to liquidated damages to be paid by the contractor to VA in the event of a data breach of any sensitive personal information processed or maintained by the contractor or any subcontractor under the contract. Such liquidated damages will be used for the purpose of VA providing credit protection services.

We propose to add a new subpart 811.5, Liquidated damages, including underlying sections as follows:

We propose to add 811.500, Scope, that would provide that the subpart is to prescribe policies and procedures for using a liquidated damages clause in solicitations and contracts that involve sensitive personal information. It also states that it pertains to any solicitations and contracts involving sensitive personal information issued by another agency for or on behalf of VA through an interagency acquisition in accordance with (IAW) FAR subpart 17.5 and VAAR subpart 817.5.

We propose to add 811.501-70, Policy—statutory requirement, that provides that contracting officers are required to include a liquidated damages clause pertaining to the protection of sensitive personal information in accordance with 38 U.S.C. 5725(b), to be paid by the contractor to the VA for the provision of credit protection services to affected individuals pursuant to 38 U.S.C. 5724(b) in the event of a data breach with respect to any sensitive personal information processed or maintained by the contractor or any subcontractor under the contract.

We propose to add 811.503-70, Contract clause, that would prescribe new clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs, as described in the section describing the proposed revisions to part 852 in this preamble. The proposed clause would be required to be incorporated in VA solicitations, contracts, purchase orders, and other instruments (for both commercial and non-commercial acquisitions, as well as when using the procedures of FAR parts 8 and/or 12, or FAR part 13 as described in the Alternate versions of the clause), when access to sensitive personal information (as defined in 38 U.S.C. 5727 and in part 839) is required whether as a contractor, subcontractor, business associate or an employee of one of these entities. The clause—

• Would prohibit the disclosure of sensitive personal information to any other person or entity unless the disclosure is lawful and is expressly permitted under the contract;

• Would require contractors, subcontractors, business associates or their employees to promptly notify the contracting officer and the contracting officer's representative (COR), of any security incident that occurs involving sensitive personal information; and

• Would require that if the contractor fails to protect sensitive personal information, the contractor shall, in the event of a data breach, in place of actual damages, pay to the Government liquidated damages per affected individual in an amount to be specified and inserted by the contracting officer in accordance with current VA internal policy. The amount to be inserted by the contracting officer would represent an estimate of the cost per affected individual for VA to provide credit protection services ( e.g., notification, credit monitoring and related support) for individuals affected by a data breach.

We propose to amend 812.301, Solicitation provisions and contract clauses for the acquisition of commercial items, by removing a prescription for clause 852.212-70. This clause, which required contracting officers to review and check provisions and clauses that apply, has been removed as unnecessary and redundant to the normal selection process for provisions and clauses.

This section will also be amended by removing a prescription for clause 852.212-71, Gray Market Items, and to add prescriptions for two new clauses: 852.212-71, Gray Market and Counterfeit Items, and 852.212-72, Gray Market and Counterfeit Items—Information Technology Maintenance Allowing Other-than-New Parts. The new clauses were originally released as a VAAR Class Deviation and will be codified via this rule.

We propose to add the following authorities to part 824:

• 38 U.S.C. 5723, which requires all users of VA information and information systems to (1) Comply with all VA security policies, procedures, and practices; (2) Take security awareness training on at least an annual basis; (3) Report all actual or suspected security and privacy incidents immediately to the Information System Security Officer (ISSO) or Privacy Officer of the facility and to their immediate supervisor (in VA contracts contractors will be required to report security incidents to the contracting officer and the contractor officer's representative (COR)), as identified or directed in the contract, within one hour of discovery or suspicion); and (4) Sign and acknowledge VA's Information Security Rules of Behavior for Organizational Users ( i.e., “VA National Rules of Behavior”) on an annual basis.

• 38 U.S.C. 5724, which requires VA, in the event the Secretary determines there exists a reasonable risk for the potential misuse of sensitive personal information involved in a data breach, to provide credit protection services, as well as notification to the affected individual.

• 38 U.S.C. 5725 (a)-(c), which requires the Secretary to ensure that if a contract is entered into for the performance of any Department function that requires access to sensitive personal information include, as a condition of the contract, that a contractor shall not, directly or through an affiliate of the contractor, disclose such information to any other person unless the disclosure is lawful and is expressly permitted under the contract. This statute also requires the contractor, or any subcontractors under the contract, to promptly notify VA (within one hour of discovery or suspicion) of any actual or suspected data breach that occurs with respect to sensitive personal information. It further requires that each such contract is subject to liquidated damages to be paid by the contractor to VA in the event of a data breach of any sensitive personal information processed or maintained by the contractor or any subcontractor under the contract. Such liquidated damages will be used for the purpose of VA providing credit protection services.

We propose to amend VAAR part 824 under subpart 824.1, Protection of Individual Privacy, by adding sections 824.103-70, Protection of privacy—general requirements and procedures related to Business Associate Agreements, and 824.103-71, Liquidated damages—protection of information.

We propose to add 824.103-70, Protection of privacy—general requirements and procedures related to Business Associate Agreements (BAAs), to establish policy. This would ensure compliance with unique responsibilities to protect protected health information, and require contractors performing under VA contracts subject to unique PHI and Health Insurance Portability and Accountability Act (HIPAA) to comply with requirements in this section. It describes the requirement for a Business Associate Agreement and when that applies. It describes that the Veterans Health Administration (VHA) is a HIPAA Covered Entity. VHA is the only administration of the Department of Veterans Affairs that is a HIPAA Covered Entity under the HIPAA Privacy Rule. It would further require that contractors or entities required to execute BAAs for contracts and other agreements become VHA business associates. It also describes those instances where other components within VA Administrations may also provide certain services and support to VHA and must receive PHI in order to do so. If these components award contracts or enter into other agreements, purchase/delivery orders, modifications and issue governmentwide purchase card transactions to help in the delivery of these services to VHA, they will also fall within the requirement to obtain a satisfactory assurance from these contractors by executing a BAA. Basically, it would require contractors, subcontractors, and their employees, where HIPAA protected health information (PHI) is created, received, maintained, or transmitted, or that will be stored, generated, accessed, exchanged, processed, or utilized in order to perform certain health care operations activities or functions on behalf of the Veterans Health Administration (VHA) as a covered entity, to execute a BAA.

In 824.103-71, Liquidated damages—protection of information, it reinforces the applicability of a liquidated damages clause as prescribed at 811.503-70 when performance under a contract requires a contractor to enter into a business associate agreement with VHA because the contractor or its subcontractor is required to create, receive, maintain, or transmit VHA PHI or is required to store, generate, access, exchange, process, or utilize PHI, for certain services or functions, on behalf of VHA. The liquidated damages clause would be required to be added even in situations where the prime contractor never directly receives VA's sensitive personal information and the same flows directly to the prime contractor's subcontractor.

We propose to add part 839, Acquisition of Information Technology, to implement and supplement FAR part 39, Acquisition of Information Technology, to incorporate, in consonance and together with the FAR, VA policies, procedures, and contract clauses necessary to control the relationship between VA and contractors or prospective contractors concerning unique aspects of the acquisition of information technology or service contracts related to information technology.

We propose to include the following authorities as the authority for the proposed policies and procedures under part 839: 38 U.S.C. 5723; 5724; 5725(a)-(c); 40 U.S.C. 121(c); 40 U.S.C. 11319(b)(1)(C); 41 U.S.C. 1121(c)(3); 1303 and 1702; and 48 CFR 1.301-1.304. The authorities are described as follows—

• 38 U.S.C. 5723, which requires all users of VA information and information systems to (1) Comply with all VA security policies, procedures, and practices; (2) Take security awareness training on at least an annual basis; (3) Report all actual or suspected security and privacy incidents to the Information System Security Officer (ISSO) or Privacy Officer of the facility and to their immediate supervisor (in VA contracts contractors will be required to report security incidents to the contracting officer and the contractor officer's representative (COR), as identified or directed in the contract, within one hour of discovery or suspicion); and (4) Sign and acknowledge VA's Information Security Rules of Behavior for Organizational Users ( i.e., “VA National Rules of Behavior”) on an annual basis;

• 38 U.S.C. 5724, which requires VA, in the event the Secretary determines there exists a reasonable risk for the potential misuse of sensitive personal information involved in a data breach, to provide credit protection services, as well as notification to the affected individual;

• 38 U.S.C. 5725(a)-(c), which requires the Secretary to ensure that if a contract is entered into for the performance of any Department function that requires access to sensitive personal information include, as a condition of the contract, that a contractor shall not, directly or through an affiliate of the contractor, disclose such information to any other person unless the disclosure is lawful and is expressly permitted under the contract. This statute also requires the contractor, or any subcontractors under the contract, to promptly notify VA (within one hour of discovery or suspicion) of any actual or suspected data breach that occurs with respect to sensitive personal information. It further requires that each such contract is subject to liquidated damages to be paid by the contractor to VA in the event of a data breach of any sensitive personal information processed or maintained by the contractor or any subcontractor under the contract. Such liquidated damages will be used for the purpose of VA providing credit protection services;

• 40 U.S.C. 121(c), which authorizes the head of each executive agency to issue orders and directives that the agency head considers necessary to carry out the FAR;

• 40 U.S.C. 11319(b)(1)(C), which stipulates that a covered agency other than the Department of Defense may not enter into a contract or other agreement for information technology or information technology services, unless the contract or other agreement has been reviewed and approved by the Chief Information Officer (CIO) of the agency, and that permits VA to use the governance processes of the VA to approve such a contract or other agreement if the VA CIO is included as a full participant in the governance processes. It also further permits that for a contract or agreement for a non-major information technology investment under this authority, the CIO may delegate the approval of the contract or agreement to an individual who reports directly to the CIO;

• 41 U.S.C. 1121(c)(3), which speaks to the authority of an executive agency under another law to prescribe policies, regulations, procedures, and forms for procurement that are subject to the authority conferred to the Administrator of the Office of Federal Procurement Policy, as well as other sections of Title 41, Public contracts, as cited in (c)(3);

• 41 U.S.C. 1303, an updated positive law codification to reflect additional authority of the VA as an executive agency to issue regulations that are essential to implement Governmentwide policies and procedures in the agency, as well as to issue additional policies and procedures required to satisfy the specific needs of the VA;

• 41 U.S.C. 1702, which addresses the acquisition planning and management responsibilities of Chief Acquisition Officers and Senior Procurement Executives, to include implementation of unique procurement policies, regulations and standards of the executive agency; and

• 48 CFR 1.301 through 1.304, which authorizes agencies to issue acquisition regulations that implement or supplement the FAR.

We propose to add 839.000, Scope of part, stating that the purpose of the part is to prescribe acquisition policies and procedures for use in acquiring information technology supplies, services and systems, and that it applies to both VA procured information technology systems as well as Interagency Acquisitions defined in FAR part 17 and VAAR part 817.

We propose to add subpart 839.1—General, with no text, and with the following sections within the subpart:

We propose to add 839.101, Policy, which identifies directives, security requirements, procedures and guidance that apply to all VA contracts and to VA contractors and subcontractors providing products, and contractors, subcontractors, and third-parties, in the performance of contractual obligations to VA when providing information technology related services.

We propose to add 839.105, Privacy, as a header only with no text.

We propose to add 839.105-70, Business Associate Agreements, information technology-related contracts and privacy, to address a key requirement that business associate agreements shall be executed whether for VHA directly as the only VA “Covered Entity” or for other contracts and agreements issued by other VA administrations and staff offices in support of VHA where contractors, subcontractors, business associates and their employees may have to access, receive or create VA sensitive information or sensitive personal information, on behalf of VHA, in order to provide certain health care operation services. (See 802.101 for the definition of information technology-related contracts.)

We propose to add 839.105-71, Liquidated damages—protection of information in information technology related contracts, in contracts for goods and services, to address the statutory requirement to include a liquidated damages clause as prescribed in 811.503-70(a) in contracts where access to sensitive personal information is provided by the VA or on its behalf.

We propose to add 839.106-70, Information technology security and privacy contract clauses, to prescribe the use of the following clauses:

In paragraph (a), contracting officers shall insert the clause at 852.239-70, Security Requirements for Information Technology Resources, and the clause 852.239-71, Information Technology Security Plan and Accreditation, in all solicitations, contracts and orders exceeding the micro-purchase threshold that include information technology services.

In paragraph (b), clause 852.239-72, Information System Design and Development, would be required to be inserted in solicitations, contracts, orders and agreements where services to perform information system design and development are required.

In paragraph (c), clause 852.239-73, Information System Hosting, Operation, Maintenance or Use, would be required to be inserted in solicitations, contracts, orders and agreements where services to perform information system hosting, operation, maintenance or use are required.

In paragraph (d), clause 852.239-74, Security Controls Compliance Testing, would be required to be inserted in solicitations, contracts, orders and agreements when the clauses at 852.239-72 or 852.239-73 are inserted.

We propose to add subpart 839.2—Information and Communication Technology, with no text, and the following sections within the subpart.

We propose to add 839.201, Scope of subpart, to state that the subpart applies to all procurement of information and communication technology (ICT) supplies, services, and information and to require compliance with Section 508 standards. Section 508 standards now refer to ICT in lieu of electronic and information technology, so VA is adopting the same terminology.

We propose to add 839.203, Applicability, to require submission of a VA Section 508 Checklist when required in VA solicitations, and to provide a website to help businesses ensure compliance with VA Section 508 Standards. This would assist VA in the evaluation of offeror's proposals when an acquisition involves the acquisition of information technology or the furnishing of services related to acquisition of information technology as defined in this part. The form will be available either in solicitations or via the website link identified.

We propose to add 839.203-70, Information and communication technology accessibility standards—contract clause and provisions, to prescribe new solicitation provision 852.239-75, Information and Communication Technology Accessibility Notice, and new contract clause 852.239-76, Information and Communication Technology Accessibility, which requires the use of the VA Section 508 Checklists.

We propose to add clause 852.204-71, Information and Information Systems Security, that would require contractors, subcontractors, their employees, third-parties, and business associates with access to VA information, information systems, or information technology (IT) or providing and accessing IT-related contracts (see 802.101), shall adhere to VA Directive 6500, VA Cybersecurity Program, and the directives and handbooks in the VA 6500 series related to VA information (including VA sensitive information and sensitive personal information and information systems security and privacy), as well as those set forth in the contract specifications, statement of work, or performance work statement. These include, but are not limited to, VA Handbook 6500.6, Contract Security; and VA Directive and Handbook 0710, Personnel Security and Suitability Program, which establishes VA's procedures, responsibilities, and processes for complying with current Federal law, Executive Orders, policies, regulations, standards and guidance for protecting VA information, information systems (see 802.101, Definitions) security and privacy, and adhering to personnel security requirements when accessing VA information or information systems. It would describe in detail requirements for access to VA information and VA information systems and appropriate security and protection requirements; information on requirement for contractor operations in the United States; Contractor/subcontractor employee reassignment and termination notification requirements; VA information custodial requirements to include release, publication, and use of data, as well as media sanitization requirements; data retention, destruction and contractor self-certification requirements and use and copying of VA data and information; information with respect to violation of information custodial requirements, encryption, firewall and web services security controls, and disclosure of VA data and information. The clause also would cover compliance with privacy statutes and applicable regulations, as well as the requirement to report known or suspected security or privacy incidents. It further describes security incident investigation requirements and data breach notification requirements. It goes on to detail specific annual training requirements and the requirement to complete and such mandatory training requirements and complete acknowledgement of the VA Information Security Rules of Behavior for Organizational Users. A specific subcontract flow down requirement is also included.

We propose to add clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs, that provides that if the contractor fails to protect VA sensitive personal information which results in a data breach, the contractor shall, in place of actual damages, pay to the Government liquidated damages in an amount per affected individual, inserted by the contracting officer based on internal VA policy, in order to cover costs related to notification, data breach analysis and credit monitoring for such individuals. In the event the contractor provides payment of actual damages in an amount determined to be adequate by the contracting officer, the contracting officer may forgo collection of liquidated damages. The contracting officer would insert Alternate I in all solicitations or contracts, in commercial items acquisitions awarded under the procedures of FAR part 8 or FAR part 12, and would insert Alternate II in all solicitations, contracts, or orders, in simplified acquisitions exceeding the micro-purchase threshold that are for other than commercial items awarded under the procedures of FAR part 13 (see FAR 13.302-5(d)(1) and the clause at FAR 52.213-4).

We propose to remove clause 852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items, as redundant to other FAR clauses.

We propose to remove clause 852.212-71, Gray Market Items, and to add a new clause in its place, 852.212-71, Gray Market and Counterfeit Items. This new clause would require that no used, refurbished, or remanufactured supplies or equipment/parts shall be provided. It would state that any procurement where the clause is inserted is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be permitted to be provided. The clause would also specify that no counterfeit supplies or equipment/parts shall be provided. Unlawful or unauthorized substitutions are set forth in the clause and include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics. The clause would also require that all vendors under the solicitation or contract shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, and would be required to be verified by an authorization letter or other documents from the OEM.

We propose to add 852.212-72, Gray Market and Counterfeit Items—Information Technology Maintenance Allowing Other-than-New Parts. This new clause would permit used, refurbished, or remanufactured parts to be provided. However, no gray market supplies or equipment shall be permitted to be provided. The clause would also require that no counterfeit supplies or equipment shall be provided. The clause would also require that all vendors shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system and would be required to be verified by an authorization letter or other documents from the OEM. Both proposed clauses are VA clauses that were originally released via a Class Deviation that we propose for codification as a part of this rulemaking.

We propose to add clause 852.239-70, Security Requirements for Information Technology Resources, to specify that contractors shall be responsible for information technology security for all systems connected to a Department of Veterans Affairs (VA) network or operated by the contractor for VA, regardless of location. This clause is applicable to all or any part of the contract that includes information technology resources or services in which the contractor has physical or electronic access to VA information that directly supports the mission of VA. Examples of tasks that require security provisions include—

(1) Hosting of VA e-Government sites or other information technology operations;

(2) Acquisition, transmission, or analysis of data owned by VA with significant replacement cost should the contractor's copy be corrupted; and

(3) Access to VA general support systems/major applications at a level beyond that granted the general public, e.g., bypassing a firewall.

The clause would also require the contractor to develop, provide, implement, and maintain an Information Technology Security Plan. This plan shall describe the processes and procedures that the contractor will follow to ensure appropriate security of information technology resources developed, processed, or used under this contract. The clause would require that within 30 days after contract award, the contractor shall submit the Information Technology Security Plan to the contracting officer for review. This plan shall detail the approach contained in the offeror's proposal, sealed bid or quotation. Upon acceptance by the contracting officer, the Plan will be incorporated into the contract by contract modification. As required by current VA policy, the contractor shall submit written proof of information technology security accreditation to the contracting officer. It also specifies specifically as pertains to information technology related contracts that its employees performing services under this contract complete VA security awareness training on an annual basis. This includes signing an acknowledgment that they have read, understand, and agree to abide by the VA Information Security Rules of Behavior for Organizational Users (VA National Rules of Behavior) as required by 38 U.S.C. 5723; FAR 39.105, Privacy; clause 852.204-71, Information and Information Systems Security, and this clause on an annual basis.

We propose to add provision 852.239-71, Information Technology Security Plan and Accreditation, that would require that all offers submitted in response to this solicitation or request for quotation shall address the approach for completing the security plan and accreditation requirements in clause 852.239-70, Security Requirements for Information Technology Resources.

We propose to add clause 852.239-72, Information System Design and Development, which would be required in all solicitations, contracts, purchase orders and agreements where services to perform information system design and development are required. The contractor/subcontractor shall comply with the Privacy Act of 1974 (the Act)) and VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies— (1) the Systems of Records (SOR); and (2) the design, development, or operational work that the contractor/subcontractor is to perform. During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with VA Directive 6508, Implementation of Privacy Threshold Analysis and Privacy Impact Assessment.

We propose to add clause 852.239-73, Information System Hosting, Operation, Maintenance, or Use, which would be required in all solicitations, contracts, purchase orders and agreements where services to perform information system hosting, operation, maintenance or used are required. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all applicable Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations, the Privacy Act and other required VA confidentiality statutes included in VA's mandatory yearly training and privacy handbooks, Federal Information Security Management Act (FISMA), National Institute of Standards and Technology (NIST), Federal Information Processing Standards (FIPS), and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent to or exceed, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the contracting officer's representative (COR) and approved by VA Privacy Service prior to approval to operate. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the Privacy Impact Assessment and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Electronic copies of the assessment must be provided to the COR. Media ( e.g., hard drives, optical disks, CDs, back-up tapes) used by the contractor/subcontractor that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per VA Directive 6500 requirements and as required by current VA policy. This must be completed within 30 days of termination of the contract.

We propose to add clause 852.239-74, Security Controls Compliance Testing, which would be required in solicitations, contracts, orders and agreements, when the clauses at 852.239-72 or 852.239-73 are inserted. Clause 852.239-73 would provide notice that VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by a contractor under the clauses contained within the contract. Clause 852.239-73 provides that with 10 working-days' notice, at the request of VA, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of the Inspector General. VA may conduct a security control assessment on shorter notice, to include unannounced assessments, as determined by VA in the event of a security incident or at any other time.

We propose to add solicitation provision 852.239-75, Information Communication and Technology Accessibility Notice, and clause 852.239-76, Information and Communication Technology Accessibility, that require the use of the VA Section 508 Checklists to be submitted under solicitations and contracts, and that provide additional information regarding the VA Section 508 website.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). E.O. 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866.

The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

This proposed rule includes provisions constituting collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) that require approval by the Office of Management and Budget (OMB). Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking action to OMB for its review.

OMB assigns control numbers to collections of information it approves. VA may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. VA is describing four groups of new collections of information in this rule under the Paperwork Reduction Act of 1995 for four separate OMB Control Numbers related to—

VAAR Part 804 related information collection:

1. Proposed clause, 852.204-71, Information and Information Systems Security, and section 804.1970, Information security policy—contractor general responsibilities.

VAAR Part 811 related information collection:

2. Proposed section 811.503-70, Contract clause, and proposed clause 852.211-70, Liquidated Damages—Reimbursement for Data Breach Costs.

VAAR Part 812 related information collection:

3. Proposed section 812.301(f), Solicitation provisions and contract clauses for the acquisition of commercial items, and proposed clauses 852.212-71, Gray Market and Counterfeit Items, and 852.212-72, Gray Market and Counterfeit Items—Information Technology Maintenance Allowing Other-than-New Parts.

VAAR Part 839 related information collection:

4. Proposed section 839.106-70, Information technology security and privacy clauses, and proposed clauses 852.239-70, Security Requirements for Information Technology Resources; 852.239-72, Information System Design and Development; and 852.239-73, Information System Hosting, Operation, Maintenance or Use. If OMB does not approve the collections of information as requested, VA will immediately remove the provisions containing a collection of information or take such other action as is directed by OMB.

Written comments and recommendations for the proposed collections of information should be sent within 60 days of publication of this proposed rule through Federal Docket Management System (FDMS) at www.Regulations.gov or to Rafael Taylor, Office of Acquisition & Logistics, Procurement Policy & Warrant Management Services (003A2A), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420 or email to rafael.taylor@va.gov.

OMB is required to make a decision concerning the collections of information contained in this proposed rule between 30 and 60 days after publication of this document in the Federal Register . Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication. This does not affect the deadline for the public to comment on the proposed rule.

The Department considers comments by the public on proposed collections of information in—

• Evaluating whether the proposed collections of information are necessary for the proper performance of the functions of the Department, including whether the information will have practical utility;

• Evaluating the accuracy of the Department's estimate of the burden of the proposed collections of information, including the validity of the methodology and assumptions used;

• Enhancing the quality, usefulness, and clarity of the information to be collected; and

• Minimizing the burden of the collections of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The collections of information contained in this proposed rule at 48 CFR chapter 8 are described specifically and immediately following this paragraph, under their respective titles.

VAAR Part 804 related collections of information:

The collection of information contained in proposed clause, 852.204-71, Information and Information Systems Security and new section 804.1970, Information security policy—contractor general responsibilities, is described immediately following this paragraph.

Summary of collection of information:

We propose the use of clause 852.204-71, Information and Information Systems Security, as prescribed at 804.1903; and propose section 804.1970, Information security policy—contractor general responsibilities.

New proposed section 804.1970 and VAAR clause 852.204-71, Information and Information System Security, would require contractors, subcontractors, their employees, third-parties, and business associates who perform under a contract with access to VA information, information systems, or information technology (IT) or providing and accessing IT-related goods and services, to be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. The clause and information collection requirement would be inserted in solicitations, contracts, purchase orders and agreements where VA information, VA sensitive information (including sensitive personal information or protected health information (PHI)), when the clause at FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems, is required to be included in accordance with FAR 4.1903.

Description of need for information and proposed use of information:

This information collection requirement is needed to protect the safety and health of the nation's Veterans and to protect the security and integrity of VA information and VA sensitive information.

Clause 852.204-71 and section 804.1970 contain the following information collection requirements from the public:

Total Burden Hours: 4,069.

Total Number of Respondents: 8,223.

Average Number of Respondents: 1,175.

Total Annual Responses: 8,223.

Average Annual Responses: 1,175.

Total estimated annual cost to all respondents: $189,371 (4,069 hours at $46.54 per hour). This is based on the Bureau of Labor Statistics May 2020 Occupational Employment and Wages code “15-1231 Computer Network Support Specialists” mean hourly wage of $34.16 plus 36.25% fringe benefits per OMB Memo M-08-13 dated March 11, 2008.

VA gathered data for FY 2018, 2019 and 2020 across 11 North American Industry Classification System (NAICS) where such information collection requirements may be inserted into solicitations and contracts. Then VA looked at the types of information collection requirements or burden may be required by the clause. Of the potential pool of previously awarded contracts (to both large and small businesses) during the three fiscal years where the proposed clause would be required to be included in solicitations and resulting contracts, VA calculated the average number of contracts awarded during the three fiscal years. We then used the average number of awards and estimated that for the purpose of identifying any potential information collection burden for contractor/subcontractor employee reassignment and termination notification of information collection requirements, only 45% would contain potential information collection requirements. The remaining information collection requirement categories are estimated as follows:

• VA estimates that 30% of the average number of contracts awarded during the three fiscal years in the identified 6 of 11 NAICS codes would require the clause and potential information collection requirement for report of known or suspected security/privacy incident and data breach.

• VA estimates that 100% of the average number of contracts awarded during the three fiscal years in the identified NAICS codes would require the clause and potential information collection requirement for the contractor/subcontractor employee training and certificates, and would be applicable when employees are onboarded by contractors.

• VA estimates no more than 15% of the average number of contracts awarded during the three fiscal years in the identified NAICS codes would require the clause and potential information collection requirement for the submission of data retention, destruction plan and contractor self-certification.

• VA estimates that 100% of the average number of contracts awarded during the three fiscal years in the identified eight of 11 NAICS codes would require the clause and potential information collection requirement for maintain records and compliance reports regarding HIPAA security and Privacy Rule compliance.

• VA estimates that 100% of the average number of contracts awarded during the three fiscal years in the identified NAICS codes would require the clause and potential information collection requirement for the submission of a detailed security plan.

• VA estimates no more than 5% of the average number of contracts awarded during the three fiscal years in the identified NAICS codes that would require the clause and potential information collection requirement for the report of all requests for, demands for, production of, or inquiries, including court orders, about VA information and information systems, would be applicable.

Contractor/subcontractor employee reassignment and termination notification.

Why we need to publish a rule. Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, or removing species from the Federal Lists of Endangered and Threatened Wildlife and Plants. In the case of any proposed rule to list, reclassify, or delist a species, we must publish a notice of such proposal in the Federal Register . Therefore, in order to remove Okaloosa darters from the List, we must publish a proposed rule.

What this document does. This action proposes to remove Okaloosa darters from the List of Endangered and Threatened Wildlife ( i.e., “delist” the species) based on its recovery.

The basis for our action. Under the Act, we may determine that a species is an endangered species or a threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.

The determination to delist a species must be based on an analysis of the same factors. Under the Act and our implementing regulations at 50 CFR 424.11, we may delist a species if the best available scientific and commercial data indicate that: (1) The species is extinct; (2) the species does not meet the definition of an endangered species or a threatened species when considering the five factors listed above; or (3) the listed entity does not meet the statutory definition of a species. Here, we have determined that Okaloosa darters should be proposed for delisting under the Act because, based on an analysis of the five listing factors, it has recovered and no longer meets the definition of an endangered or threatened species.

We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments and information from the public, other concerned governmental agencies (including but not limited to State and Federal agencies and city or county governments), Native American Tribes, the scientific community, industry, or any other interested party concerning this proposed rule.

We particularly seek comments on:

(1) Information concerning the biology and ecology of the Okaloosa darter;

(2) Relevant data concerning presence or absence of current or future threats to the Okaloosa darter and its habitat;

(3) Information regarding management plans or other mechanisms that provide protection to the Okaloosa darter and its habitat;

(4) Information on the potential for changes in precipitation levels and air and water temperatures to affect the Okaloosa darter due to changes in the climate or other reasons; and

(5) The draft PDM plan and the methods and approach described.

Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.

Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made “solely on the basis of the best scientific and commercial data available.”

You may submit your comments and materials concerning this proposed rule by one of the methods listed in ADDRESSES . We request that you send comments only by the methods described in ADDRESSES .

If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov.

Because we will consider all comments and information we receive during the comment period, our final determinations may differ from this proposal. Based on the new information we receive (and any comments on that new information), we may conclude that the species should remain listed as threatened.

Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in DATES . Such requests must be sent to the address shown in FOR FURTHER INFORMATION CONTACT . We will schedule a public hearing on this proposal, if requested, and announce the date, time, and place of the hearing, as well as how to obtain reasonable accommodations, in the Federal Register and local newspapers at least 15 days before the hearing. For the immediate future, we will provide these public hearings using webinars that will be announced on the Service's website, in addition to the Federal Register . The use of these virtual public hearings is consistent with our regulations at 50 CFR 424.16(c)(3).

On June 4, 1973, we published a final rule in the Federal Register (38 FR 14678) listing Okaloosa darters as endangered under the Endangered Species Conservation Act (Pub. L. 91-135) due to its extremely limited range, habitat degradation, and apparent competition from a possibly introduced related species, the brown darter (Etheostoma edwini). A 5-year status review was conducted in 2007 (USFWS 2007, entire), and we recommended downgrading the species' classification to threatened as a result of substantial reduction in threats to the species, significant habitat restoration in most of the species' range, and a stable or increasing trend of Okaloosa darters in all stream systems. We reclassified Okaloosa darters as threatened under the Act on April 1, 2011, and established a rule under section 4(d) to further provide for its conservation (76 FR 18087); the section 4(d) rule is at 50 CFR 17.44(bb). On August 6, 2018, we initiated a 5-year review for Okaloosa darters (83 FR 38320). This proposed rule also serves as our 5-year review.

A species status assessment (SSA) team prepared an SSA report for Okaloosa darters (USFWS, 2019, entire). The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species. In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing actions under the Act, we sought the expert opinions of six appropriate specialists regarding the SSA. The Service received two responses.

The Okaloosa darter is a small (maximum size 49 millimeters (mm), 1.93 inches (in)) percid fish. General body coloration varies from red-brown to green-yellow dorsally, and lighter ventrally, although breeding males have a bright orange submarginal stripe on the first dorsal fin (Burkhead et al. 1992, p. 23). The Okaloosa darter is a member of Order Perciformes, Family Percidae and is a distinct species within the genus Etheostoma (Burkhead et al. 1992, p. 23), although it remains uncertain as to which subgenus this species belongs ( e.g., Song et al. 1998 pp. 348-351; Smith et al. 2014 pp. 259-260).

The Okaloosa darter is a narrow endemic, known to occur in only the tributaries and main channels of six clear stream systems that drain into three Choctawhatchee Bay bayous (Toms, Boggy, and Rocky) in Walton and Okaloosa Counties in northwest Florida: Toms, Turkey, Mill, Swift, Deer Moss (formerly known as East Turkey or Turkey Bolton), and Rocky Creeks. Approximately 90 percent of the 457-square-kilometer (176-square-mile) watershed drainage area that historically supported Okaloosa darters is Federal property under the management of Eglin Air Force Base (Eglin AFB), including about 98.7 percent of the stream length in the current range of the Okaloosa darter. Eglin AFB encompasses the headwaters of all six of these drainages, and the remainder of these streams flow out of Eglin AFB into the urban complex of the cities of Niceville and Valparaiso (USAF 2017c, p. 3-1; 76 FR 18088, April 1, 2011).

The Okaloosa darter's breeding season extends from late March through October, although it usually peaks in April. Spawning pairs attach small numbers of eggs to vegetation, woody debris, and root mats (Collete and Yerger 1962, p. 226; Burkhead et al. 1994, p. 81); however, little is known about larval development (Burkhead et al. 1992, p. 26). Okaloosa darter spawn in the morning hours (Burkhead et al. 1992, p. 26), although courtship displays have also been observed late in the afternoon (Jelks 2018, pers. comm.). During courtship, a male will follow a single female and fertilize eggs as she deposits them singly among vegetation, roots, or woody detritus. Males will spawn with several females. As with most darters, fecundity is low (Burkhead et al. 1992, p. 26). A mean of 76 total ova (eggs) and 29 mature ova were found in 201 female Okaloosa darters, although these numbers may underrepresent annual fecundity as their prolonged spawning season is an indication of fractional spawning (eggs develop and mature throughout the spawning season) (Ogilvie 1980, p. 4; 76 FR 18088, April 1, 2011).

Longleaf pine-wiregrass-red oak sandhill communities dominate the vegetation landscape in Okaloosa darter watersheds. These areas are characterized by high sand ridges where soil nutrients are low and woodland fire is a regular occurrence. Where water seeps from these hills, acid bog communities develop, consisting of sphagnum moss ( Sphagnum sp.), pitcher plants ( Sarracenia sp.), and other plants adapted to low-nutrient soils. In other areas, the water emerges from seepage springs directly into clear flowing streams where variation of both temperature and flow is moderated by the deep layers of sand. The streams support a mixture of bog moss (Mayaca fluviatilis), bulrush (Schoenoplectus etuberculatus), golden club (Orontium aquaticum), bur-reed (Sparganium americanum), pondweed (Potamogeton diversifolius), spikerush ( Eleocharis sp.), and other aquatic and emergent plants. Okaloosa darters typically inhabit the margins of moderate- to fast-flowing streams where detritus (organic matter, including leaves, twigs, and sticks), root mats, and vegetation are present (Burkhead et al. 1992, p. 25; 76 FR 18088, April 1, 2011). They are rarely found in areas with no current or in open sandy areas in the middle of the stream channel. Creeks with Okaloosa darters have temperatures ranging from 7 to 22 degrees Celsius (°C) (44 to 72 degrees Fahrenheit (°F)) in the winter to 22 to 29 °C (72 to 84 °F) in the summer (Mettee and Crittenden 1977, p. 5; Tate 2018, pers. comm.; Jelks 2018, pers. comm). Overhead canopies range from open to fully closed depending on stream width and fire history (Jordan 2018, pers. comm.). Okaloosa darter thrive in reaches with relatively open canopies, likely due to either increased abundance of submerged vegetation that is used preferentially for spawning or increased secondary production of insect prey (Ingram 2018, p. 11).

Okaloosa darter abundance has been quantified by visual census at multiple sites annually since 1995. Densities in 1995 averaged 1.2 (± 0.8; ± 1 standard deviation) Okaloosa darter per meter (3.28 feet) of stream length. In 2005, a rangewide survey estimated the species' population size at 822,500 (95 percent Confidence Interval 662,916 to 1,058,009). A repeat rangewide survey in 2014 indicated that overall abundance declined by about 24 percent from 2005 (Jordan and Jelks 2018, pp. 10-11). However, 2005 was an unusually good year for Okaloosa darter, and the 2014 estimates reflect some declines associated with dense canopy cover.

A thorough review of the taxonomy, life history, ecology, and overall viability of Okaloosa darters is presented in the SSA report (USFWS 2019, entire; available at https://www.fws.gov/southeast/ and at http://www.regulations.gov under Docket No. FWS-R4-ES-2021-0036).

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Under section 4(f)(1)(B)(ii), recovery plans must, to the maximum extent practicable, include objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of section 4 of the Act, that the species be removed from the List.

Recovery plans provide a roadmap for us and our partners on methods of enhancing conservation and minimizing threats to listed species, as well as measurable criteria against which to evaluate progress towards recovery and assess the species' likely future condition. However, they are not regulatory documents and do not substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species, or to delist a species, is ultimately based on an analysis of the best scientific and commercial data available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan. There are many paths to accomplishing recovery of a species, and recovery may be achieved without all of the criteria in a recovery plan being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be accomplished. In that instance, we may determine that the threats are minimized sufficiently and that the species is robust enough that it no longer meets the definition of an endangered species or a threatened species. In other cases, we may discover new recovery opportunities after having finalized the recovery plan. Parties seeking to conserve the species may use these opportunities instead of methods identified in the recovery plan. Likewise, we may learn new information about the species after we finalize the recovery plan. The new information may change the extent to which existing criteria are appropriate for identifying recovery of the species. The recovery of a species is a dynamic process requiring adaptive management that may, or may not, follow all of the guidance provided in a recovery plan.

The objective of the Okaloosa darter recovery plan is to restore and protect habitat and stream ecosystems so that Okaloosa darters may be initially downlisted (which occurred in 2011) and eventually delisted. The Okaloosa darter is a narrow endemic that occupies the unique habitats of only six stream systems. Recovery objectives are focused on habitats within their historical range. The recovery plan states that Okaloosa darters will be considered for delisting when:

1. (a) All downlisting criteria have been met; (b) historical habitat of all six streams has been restored to support viable populations of Okaloosa darters (including degraded sections of Mill, Swift, and Tom Creeks); (c) erosion at clay pits, road crossings, and steep slopes has been minimized to the extent that resembles historical predisturbance condition; (d) longleaf restoration and watershed management practices on Eglin AFB are in effect; (e) natural, historical flow regimes are maintained; and (f) water quality and riparian habitat have been significantly improved and maintained.

2. (a) Cooperative and enforceable agreements are in place to protect habitat and water quality and quantity for the historical range outside of Eglin AFB; and (b) management plans that protect and restore habitat and water quality and quantity have been effective and are still in place for the 90 percent of the historical range currently managed by Eglin AFB.

3. Okaloosa darter populations at monitoring sites consist of two or more age-classes and remain stable or increasing in all six streams over a period of 20 consecutive years.

4. No foreseeable threats exist that would impact the survival of this species (assumes military mission is compatible).

The following discussion summarizes the recovery criteria and information on recovery actions that have been implemented under each delisting criterion.

Delisting Criterion #1: All reclassification criteria have been met. (This criterion has been met.)

Delisting Criterion #2: Restore and protect habitat in the six Okaloosa darter stream watersheds.

The Okaloosa darter is naturally restricted in distribution to six streams, of which about 90 percent of the basins are on Eglin AFB and the remaining 10 percent in the Niceville and Valparaiso municipal area. Because of the specific habitat requirements and limited distribution of the darter, habitat that is essential for spawning, rearing, feeding, and cover needs to be restored and protected to prevent the species from declining irreversibly and to recover the species.

Much progress has been made towards actions identified for Okaloosa darters under this criterion since the species was downlisted from endangered to threatened. Erosion into the streams has been reduced to background levels, nearly all fish passage barriers on Eglin AFB have been removed, several projects have been completed to restore and reconnect stream habitat, and conservation agreements with local landowners have been put in place on private lands to protect stream and floodplain habitat. The Eglin AFB erosion control program, habitat restoration programs, and habitat protections agreed to by private landowners have improved habitat for Okaloosa darters sufficient to partially meet this criterion.

Delisting Criterion #3: Erosion at clay pits, road crossings, and steep slopes has been minimized to the extent that resemble historical pre-disturbance condition. (This criterion is partially fulfilled and progress is ongoing.)

Delisting Criterion #4: Longleaf restoration and watershed management practices on the Eglin AFB are in effect. (This criterion is largely fulfilled. Both longleaf and watershed management practices are in effect on Eglin AFB.)

Delisting Criterion #5: Natural, historical flow regimes are maintained. (This criterion has been met.)

Delisting Criterion #6: Water quality and riparian habitat have been significantly improved and maintained. (This criterion is partially fulfilled, and progress is ongoing.)

Delisting Criterion #7: Cooperative and enforceable agreements are in place to protect habitat and water quality and quantity for the historical range outside of Eglin AFB ((2)(a), above), and management plans that protect and restore habitat and water quality and quantity have been effective and are still in place for the 90 percent of the historical range currently managed by Eglin AFB ((2)(b), above).

About 90 percent of the 51,397 hectares (127,000 acres) that represent the drainage basins of darter streams are managed by Eglin AFB. Eglin AFB will continue to include management for Okaloosa darters in the Eglin AFB's Integrated Natural Resources Management Plan (INRMP), changes to which are reviewed and approved by both the Service and the Florida Fish and Wildlife Conservation Commission (FWC) as specified under the Sikes Act. Eglin AFB has no plans to remove management from the INRMP or limit management within Okaloosa darter watersheds (Tate 2020, pers. comm.). In fact, Eglin AFB is working with the Service to shift prescribed fire management to reduce canopy cover in Okaloosa darter streams to further bolster darter numbers and stabilize monitoring sites with observed declines. Additionally, Eglin AFB has placed protective buffers on Okaloosa darter streams to prevent land use changes and management actions that might adversely affect Okaloosa darters or their habitat, thus protecting 90 percent of the darter's watershed area from impacts (Felix 2020, pers. comm.).

Outside the Eglin AFB boundary, the remaining 485.6 hectares (1,200 acres) of Okaloosa darter habitat are situated in the Niceville-Valparaiso urban complex. Okaloosa darters are found at reduced levels or absent from much of this area. Current stream impacts include erosion, non-point discharge of nutrients and pollutants, impoundment, alteration of flow, and culverting. Conservation agreements and habitat buffering on private property further prevent adverse impacts to an additional 3-4 percent of the potential range (Ruckel Properties 2018, entire). In total, 90-95 percent of the watershed area has established protections, and monitoring will ensure this criterion continues to be met.

Delisting Criterion #8: Management plans that protect and restore habitat and water quality and quantity have been effective and are still in place for the 90 percent of the historical range currently managed by Eglin AFB. (This criterion is largely fulfilled through Eglin's 2007 INRMP.)

Delisting Criterion #9: Okaloosa darter populations at monitoring sites consist of two or more age-classes and remain stable or increasing in all six streams over a period of 20 consecutive years.

Monitoring for Okaloosa darters has been conducted annually at 21 core sites distributed throughout the range since 1995. In 2005, 2014, and 2020, expanded monitoring efforts of 58 sites were conducted to estimate the population size and inform the status review and species status assessment. Additional monitoring has been conducted to support specific research projects. In general, Okaloosa darter numbers increased in the late 1990's through early 2000's, at which time declines were observed at a subset of sites (Jordan and Jelks 2020). Multiple year classes have been recorded in each of the six watersheds in all years of study, regardless of declines (Jordan and Jelks 2020). Although declines have been identified in portions of the range, the majority of the declines could be associated with dense canopy cover limiting vegetation and primary productivity in the stream (Jordan and Jelks 2020). Eglin AFB natural resource managers are working to shift habitat management activities like prescribed fire, vegetative spraying, or mechanical timber stand improvement to limit excessive riparian growth along Okaloosa darter streams. Monitoring data will continue to be collected and used to assess and inform management actions in Okaloosa darter watersheds.

Regardless of declines, the overall population estimate for Okaloosa darters was greater than 500,000 individuals in 2020 (Jordan and Jelks 2020) and range-wide densities generally remain above 2 darters per meter of inhabited stream (Jordan and Jelks 2020), which is approximately 90% of the species' historic range. Maintaining multiple viable populations substantially reduces the risk of species extinction, and future scenario modelling suggests that resiliency and redundancy will persist into the foreseeable future (USFWS 2019). This criterion has been fully met.

Delisting Criterion #10: No foreseeable threats exist that would impact the survival of this species.

Potential future threats to the Okaloosa darter are to its habitat, particularly in three of the smaller basins: Mill Creek, Swift Creek, and Deer Moss Creek. Human activity has degraded physical and chemical habitat quality in these basins, though only the Deer Moss Creek population exhibits declines. Mill Creek is almost entirely within the Eglin AFB golf course, who sponsored a major stream restoration in 2007 that nearly doubled the inhabited stream in this watershed. The golf course has also implemented best management practices (BMPs) for herbicide and pesticide application that limit impacts to Mill Creek. The lower portions of Swift Creek are nearly completely urbanized, but our models show that the planned restoration of College Pond would nearly double the population size. Stream restoration at College Pond would not only add substantial habitat to the watershed, it would also remove a fish passage barrier to multiple tributaries that are currently unoccupied by Okaloosa darters. Eglin AFB is currently working with USFWS, FWC, and community partners to begin engineering designs for this project.

The portions of Deer Moss Creek outside Eglin AFB are currently subject to development pressure; however, during the FWC endangered species permit process, developments and other actions must show a net benefit to the species before approval by the State. In the case of Deer Moss Creek, a conservation plan was developed that prevents construction in all wetlands and an upland buffer, requires bridges that completely span all wetlands, and requires the removal of two fish passage barriers within the watershed, among other provisions (Ruckel Properties, 2014). In addition to protections from urbanization in lower Deer Moss Creek, the Niceville wastewater treatment facility was upgraded in 2010 to reduce nutrients in sprayfield effluent. Recent studies at Eglin AFB have found that groundwater transport in the Deer Moss Creek watershed is approximately 12-18 years (Landmeyer 2020, unpublished data), so the water quality in the stream should improve over time.

Because the range of the Okaloosa darter is almost entirely on Federal lands, nearly all actions in this area were subject to the interagency cooperation requirements of section 7. Following delisting, the protections under section 7 will no longer apply; however, Eglin AFB plans to maintain protections for the Okaloosa darter by maintaining a buffer around Okaloosa darter streams during infrastructure and mission planning, developing enhanced BMPs to limit erosion during construction projects and continue monitoring stream health (Felix 2020, pers. comm.). Additionally, any action on Federal or private lands that impact wetlands would require permits under the Clean Water Act. Eglin protection and restoration of Okaloosa darter streams is a substantial component of natural resources management on Eglin AFB. Approximately 90 percent of the species' range is under the management of Eglin AFB; urbanization will have little to no future effect. Because Okaloosa darters occur in multiple stream systems, which provides redundancy, and no long-term threats are presently impacting Okaloosa darters at the species level in the foreseeable future, this criterion has been met.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an endangered species or a threatened species. The Act defines an endangered species as a species that is “in danger of extinction throughout all or a significant portion of its range,” and a threatened species as a species that is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:

(A) The present or threatened destruction, modification, or curtailment of its habitat or range;

(B) Overutilization for commercial, recreational, scientific, or educational purposes;

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

(E) Other natural or manmade factors affecting its continued existence.

These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.

We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.

However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the expected response by the species, and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species now and in the foreseeable future.

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term foreseeable future extends only so far into the future as the Service can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.

It is not always possible or necessary to define foreseeable future as a particular number of years. Analysis of the foreseeable future uses the best scientific and commercial data available and should consider the timeframes applicable to the relevant threats and to the species' likely responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors. In the discussion of threats and the species' response to those threats that follows, we include, where possible, either a qualitative or quantitative assessment of the timing of the threats and species' responses to those threats.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential stressors to the species. The SSA report does not represent a decision by the Service on whether the species should be proposed for delisting. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies. In this section, we summarize the key conclusions from the SSA report; the full SSA report can be found on the Southeast Region website at https://www.fws.gov/southeast/ and at http://www.regulations.gov under Docket No. FWS-R4-ES-2021-0036.

To assess the Okaloosa darter's viability, we used the three conservation biology principles of resiliency, representation, and redundancy (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency describes the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years), redundancy supports the ability of the species to withstand catastrophic events (for example, droughts, large pollution events), and representation supports the ability of the species to adapt over time to long-term changes in the environment (for example, climate changes). In general, the more redundant and resilient a species is, and the more representation it has, the more likely it is to sustain populations over time, even under changing environmental conditions. Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.

The SSA process can be categorized into three sequential stages. During the first stage, we evaluated individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time. We use this information to inform our regulatory decision.

In this discussion, we review the biological condition of the species and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability.

Stressors to Okaloosa darter stem from two main sources: Land use and management practices on Eglin AFB and urbanization around the lower reaches of streams outside of Eglin AFB. Urbanization is the greatest threat to Okaloosa darter, as development leads to pollution, erosion, and sedimentation, altered water flows, and dispersal barriers through multiple pathways. Land use and management practices such as road building, timber harvesting, and fire suppression can affect abundance of Okaloosa darter on Eglin AFB. The effects of a changing climate, such as increasing stream temperatures, could become a threat to Okaloosa darters throughout their geographic range in the future; however, the degree and magnitude of any impacts are uncertain at this time. Impending development along Deer Moss Creek would likely be completed in 20 years; however, a conservation plan is in place to minimize impacts to Deer Moss Creek.

Sediment loading is perhaps the primary factor continuing to impact Okaloosa darter. The primary sources of sediment to aquatic ecosystems on Eglin AFB are: accelerated streamside erosion, borrow pits (areas where clay, sand, or gravel are removed for use at other locations), developed areas, weapon test ranges, silviculture, and roads (Rainer et al. 2005, p. 1-1). Sedimentation can result from unpaved roads, road crossings, road or development projects ( e.g., solar power grids), and can also result from poor stormwater control or runoff during heavy, localized rains. Even though the species has been impacted by these threats, the current population estimate is approximately 1.2 million darters across its range.

Management for Okaloosa darters is outlined in Eglin AFB's INRMP, which includes specific goals and objectives to improve Okaloosa darter habitat, and Eglin AFB has demonstrated a commitment to recovery of the species. Therefore, management and other conservation actions are much more likely to occur on Eglin AFB than surrounding properties (USFWS 2007, p. 5). These streams on Eglin AFB flow mostly through forested, natural settings, whereas off-installation, they interface mostly with urban and suburban areas. Eglin AFB personnel have implemented this effective habitat restoration program to control erosion from roads, borrow pits, and cleared test ranges. Since 1995, Eglin AFB personnel have restored 317 sites covering 196.2 hectares (484.8 acres) that were eroding into Okaloosa darter streams, including borrow pits and other non-point sources (pollution created from larger processes and not from one concentrated point source, like excess sediment from a construction site washing into a stream after a rain) of stream sedimentation (76 FR 18090, April 1, 2011). Erosion into the streams has been reduced to background levels, nearly all fish passage barriers on Eglin AFB have been removed, several restoration projects have been completed to restore and reconnect stream habitat, and conservation agreements with local landowners (on 3-4 percent of potential Okaloosa darter range) have been put in place on private lands to protect stream and floodplain habitat (Wetland Sciences 2011, entire).

Eglin AFB personnel estimate that these and other restoration efforts have reduced soil loss from roughly 69,000 tons/year in Okaloosa darter watersheds in 1994 to approximately 2,500 tons/year in 2010 (Pizzolato 2017, pers. comm.). While soils will always be highly susceptible to disturbance and sedimentation and erosion could impact the species, habitat restoration work has improved Okaloosa darter habitat within the base. Improvements like bottomless culverts, bridges over streams, and bank restoration and revegetation have resulted in increased clarity of the water, stability of the channel and its banks, and expansion of Okaloosa darters into new areas within drainages (76 FR 18090, April 1, 2011). Poorly designed silviculture programs can result in accelerated soil erosion and stream sedimentation, but Eglin AFB personnel have designed their program within Okaloosa darter habitat to avoid and minimize impacts to the aquatic ecosystems such that the program is not likely to adversely affect Okaloosa darters (USAF 2017, pp. 4-23; USFWS 2017, pp. 11-12).

Forest and timber management in Okaloosa darter drainages is generally directed toward habitat management for the red-cockaded woodpecker or fuel reduction near military test ranges and in the urban interface, which involve the use of prescribed fire, mechanical or chemical timber stand improvement as well as traditional forestry practices for timber harvest and fuel-wood. Recently timbered areas may leave exposed sandy patches, which can be susceptible to wind erosion. However, erosion has been reduced to background levels; all of these habitat management programs are coordinated through Eglin AFB and are conducted in accordance with State and Federal best management practices (USAF 2017, p. 77, INRMP forestry component plan).

Unpaved roads, their low-water stream crossings, and subsequent bank erosion probably have the greatest impact because of their distribution on Eglin AFB, relative permanence as base infrastructure, and long-term soil disturbance characteristics. The largest remaining source of sediment input to Okaloosa darter streams is the unpaved road network, which allows sediment to be washed off the road and into nearby streams, especially where they cross the stream itself. As of 2005, 87 percent (4,348 km) of the roads in Eglin AFB's road network were unpaved, and remain so currently (Felix 2018, pers. comm.).

Road crossings can be detrimental to Okaloosa darter depending on their design. Pipe culverts alter stream flow and impede movement of Okaloosa darter, whereas bridges and bottomless culverts do not. Of the 153 road crossings that previously existed in Okaloosa darter drainages, 57 have been eliminated—28 in Boggy Bayou streams and 29 in Rocky Bayou streams. Although many road crossings have been removed and restored through road closures and restoration efforts over the last few years, others remain and pose a threat to Okaloosa darter and their habitat. For example, five road crossings in the Turkey Creek drainage have repeatedly exceeded State water quality standards for turbidity (USFWS 2017, p. 11).

Road development projects also present potential threats that may negatively impact Okaloosa darter. The Mid-Bay Bridge Authority's Mid-Bay Connector Road (Connector Road), a road constructed from the terminus of the Mid-Bay Bridge to SR 85 north of Niceville, was completed in February 2014 (USFWS 2017, p. 13). Although the Connector Road crosses Okaloosa darter drainages, conservation measures included 19 stipulations to minimize impacts to darter drainages. For example, the project used environmentally sensitive bridge construction techniques and measures to minimize erosion and ground disturbance at each stream crossing and to maintain channel stability. Because the bridges were designed to maintain natural stream geomorphology and were built using appropriate methods to stabilize stream banks and provide erosion control along the stream, long-term erosion and degradation of Okaloosa darter habitat is not anticipated. Monitoring before, during, and after construction detected no significant project-related changes in abundance of Okaloosa darter above or below any of the new stream crossings (Jordan and Jelks, unpublished data). However, the project impacted multiple areas of Okaloosa darter streams via erosion associated with large storm events, and in 2012 violated erosion controls. One of the stream crossings required a full stream restoration within the project limits and downstream from the project area. Erosion-related issues were also reported in 2013 (USFWS 2017, p. 13). As part of further mitigation of the Connector Road's accumulated negative impacts on Okaloosa darters, to date the Mid-Bay Bridge Authority has improved road crossings of Okaloosa darter streams at seven sites on Eglin AFB and at one site off of Eglin AFB. As of February 2019, the Mid-Bay Bridge Authority has no plans for future corridors; however, the existing corridor could be widened to four lanes if future traffic projections justify the need (USFWS 2017, p. 13).

The construction of the Connector Road created several relatively small “orphaned” parcels of Eglin AFB-owned property, whereby the road effectively separated those parcels from the natural resources management practices employed elsewhere over the contiguous Eglin AFB reservation properties. Three of these orphan parcels lie within the Okaloosa darter geographic range (approximately 740, 170, and 260 acres) and surround segments of four occupied streams (Mill, Swift, Turkey, and Deer Moss Creeks). Eglin AFB has historically considered orphan parcels candidates both for leasing through enhanced use agreements and for real property transaction or exchange to public and private entities in order to maximize the effectiveness of its real property in supporting the United States Air Force (USAF) mission. Eglin AFB may consider the three parcels mentioned above for such transactions. However, the Eglin AFB has indicated its intent to coordinate with the Service on the impacts of any environmental impact analysis for such transactions (Felix 2018, pers. comm.).

In 2012, the Service issued a biological opinion for widening SR 123 from a two-lane undivided roadway to a four-lane divided roadway from SR 85 South to SR 85 North to the Federal Highway Administration (FHWA) (USFWS 2017, p. 13). The widening included new two-lane bridges at Toms Creek and Turkey Creek, and replacement of the culvert at the unnamed tributary to Turkey Creek with two single-span bridges. The biological opinion concluded that, while the effects of the project included displacement, injury, and mortality to Okaloosa darter resulting from construction debris, equipment movement, dredge and fill activities, sedimentation, introduction of contaminants, and habitat alteration, it would not jeopardize the continued existence of the threatened Okaloosa darter if certain measures were implemented.

In 2015 and 2016, multiple erosion control failures resulted in sediment from the project site discharging into streams occupied by Okaloosa darter: Toms Creek, Shaw Still Branch, Turkey Creek, and an unnamed tributary to Turkey Creek following storm events. The Service worked with the U.S. Army Corps of Engineers, FHWA, and the Florida Department of Transportation to develop a restoration and compensation plan; implementation began in 2018. The plan was designed to fully offset all impacts and provide a net conservation benefit to the species due to unforeseen, but preventable, impacts. In summer 2017, the Service identified additional impacts of this highway project to steepheads (deep ravines) outside of the initial defined Action Area for this project (Tate 2018, pers. comm.; USFWS 2017, pp. 13-14). Additionally, a working group including the Service and Eglin AFB was formed to develop BMPs that would prevent erosion events and that would be applied to base projects during site preparation and construction (Tate 2018, pers. comm.). The goal of this effort is to prepare BMPs and language/requirements to be included in the real estate leasing agreements, which may help ensure the species' conservation if the Act's protections are removed.

Development and construction activity in residential areas outside of Eglin AFB and primarily in the downstream-most portion of the Okaloosa darter range pose a threat due to poor stormwater runoff control and pollution prevention measures that degrade habitat and sometimes create barriers to movement between basins. Although this threat is greater in urban areas, recent failures in erosion control and stormwater management on Eglin AFB highlight the importance of thoroughly understanding how proposed activities contribute to erosion and stormwater management problems and implementing practices to minimize those effects (USFWS 2017, p. 11).

For example, in June 2017, a significant stormwater retention pond failure occurred on Eglin AFB property leased to Gulf Power and run by Gulf Coast Solar Center I, LLC (Coronal Energy), for a solar energy project. This failure caused extensive soil loss both on the leased site and offsite on Eglin AFB property. Okaloosa darter habitat in an unnamed tributary to Toms Creek was completely lost to sedimentation, and additional sediment is still located throughout the floodplain. However, this event impacted less than 0.1 percent of the estimated populations involved, and design changes have been made that are expected to fully offset all impacts and provide a net conservation benefit to the species due to unforeseen, but preventable, impacts (USFWS 2017, p. 14).

Borrow pits were a major source of sediment loading to Okaloosa darter streams cited in the 1998 darter recovery plan. At that time, 29 of 39 borrow pits located within or immediately adjacent to Okaloosa darter drainages had been restored. As of 2004, all borrow pits within Okaloosa darter drainages had been restored (59.3 ha; 146.5 ac) (USAF 2017b, pp. 3-18; USFWS 2017, p. 11).

Pollution, other than sedimentation, poses a potential threat to darters. One stream in the darter's range, lower Turkey Creek (WBID 495A), is on the Florida Department of Environmental Protection's (2018) Verified List as impaired, listing iron from a closed landfill as the pollutant (USFWS 2018, entire). Using aquatic insect sampling methods, the Service (Thom and Herod 2005, entire) found 12 sites out of 42 sampled within the darter's range to be impaired. One notable source of pollution in Shaw Still Branch and Deer Moss Creek results from wastewater treatment sprayfields (the Niceville-Valparaiso Regional Effluent Land Application Sprayfield) (USFWS 2017, pp. 12-13). Abundance declines from about 45 Okaloosa darter per 20 m in the headwaters just above the sprayfield down to 1 or fewer Okaloosa darter per 20 m in the remaining 4 km or so of stream downstream from the sprayfield (Jordan 2017, pp. 5-7; Jordan, unpublished data, Figure 8). The actual pollutant has yet to be determined, but impacted streams have high conductivity compared to the relatively sterile, ion-poor, and slightly acidic streams that are typical of the area and likely similar to streams where Okaloosa darter evolved. Contaminants found in the portions of Deer Moss Creek exposed to sprayfield effluent were shown to affect the biological processes of other species of fish in those streams (Weil et al. 2012, p. 185). Municipal wastewater with increased conductivity has been shown to negatively affect other species of darters (Hitt et al. 2016, entire; Fuzzen et al. 2016, entire).

Water withdrawals for human consumption in and around the range of Okaloosa darters are presently served by wells that tap the Floridan Aquifer, which is declining in the most populated areas near the coast (Pascale 1974, pp. 12). At this time, there is no evidence that pumping from that aquifer has reduced flows in darter streams (USFWS 2017, p. 13). To the extent that the darter drainages are spring fed (by and large they are fed by seepage), the springs are from the shallow sand and gravel aquifer that is not currently used for human consumption. Additionally, the low permeability of the Pensacola Clay confining bed likely severely limits hydraulic connectivity between the two aquifers (Schumm et al. 1995, p. 288). As long as withdrawals from the sand and gravel aquifer are minimal, local human population growth should not adversely affect water flows in the darter drainages (USFWS 2017, p. 13).

The Intergovernmental Panel on Climate Change (IPCC) concluded that warming of the climate system is unequivocal (IPCC 2014, entire). Numerous long-term changes have been observed including changes in arctic temperatures and ice, and widespread changes in precipitation amounts, ocean salinity, wind patterns, and aspects of extreme weather including droughts, heavy precipitation, heat waves, and the intensity of tropical cyclones (IPCC 2014, entire). While continued change is certain, the magnitude and rate of change is unknown in many cases (USFWS 2017, p. 14).

The current occupied range of the darter is restricted to approximately 402 km of streams in Walton and Okaloosa Counties, Florida. While science shows that global-scale increases in stream temperatures have occurred (Kaushal et al. 2010, entire; Song et al. 2018, entire), streams within the Okaloosa darter range are seepage and spring-fed, and thus thought to be thermally moderated (USFWS 2017, p. 14). However, thermal mediation varies among nearby Okaloosa darter streams, and streams that support Okaloosa darter are strongly affected by increases in air temperature (Jordan 2018, unpublished data). Information required to evaluate whether increased temperatures in streams will adversely affect Okaloosa darter is lacking; however, declines in abundance following the impoundment of small stream reaches are likely due in part to increased temperatures, and the loss of darters below larger impoundments, such as Brandt Pond and Swift Creek, are generally assumed to be due to temperature change (Jordan 2018, pers. comm.). Because the distribution of Okaloosa darters is limited, and they cannot expand northward, stream temperature increases or sea level rise that would cause stream inundation could pose a threat to Okaloosa darter by isolating the populations. The National Oceanographic and Atmospheric Administration (NOAA) (2017, entire; NOAA Sea Level Rise Viewer 2018) projects sea level rise will be around 1.84 feet by year 2050 (Sweet et al. 2017, Intermediate High scenario). While this increase will not inundate much of the darter stream systems due to topography, it could isolate the stream systems from each other, limiting genetic exchange (Tate 2018, pers. comm., NOAA Sea Level Rise Viewer 2018). However, the species has maintained genetic exchange among populations despite current and historic saltwater isolation (Austin et al. 2011).

Many streams within the range of Okaloosa darters have a history of impoundment. These impoundments were either deliberately created to produce recreational ponds or unintentionally formed following installation of a poorly designed road crossing. Culverts and other installations can also facilitate the creation of permanent impoundments by North American beavers (Castor canadensis), which take advantage of human-made alterations (Nicholson 2009, p. 5; Reeves et al. 2016, p. 1376). Okaloosa darter do not occupy impounded stream reaches (Mettee et al. 1976, p. 2; Nicholson 2009, p. 6) due to their depth and low flow rates, variable water temperatures, more accumulation of organic substrates, and higher numbers of predatory fishes than free-flowing stream reaches (Nicholson 2009, pp. 34; Reeves et al. 2016, p. 1376). Okaloosa darter living downstream of impoundments are also negatively affected, sometimes for a considerable distance. For instance, the roughly 3 km (60 percent) of Swift Creek below College Pond and roughly 2 km (100 percent) of Foxhead Branch below Brandt Pond currently lack Okaloosa darter (Jordan 2018, pers. comm.). In the absence of predators, beaver populations can become overpopulated (Nicholson 2009, p. 5). Eglin AFB currently traps and relocates nuisance beavers and removes beaver impoundments in order to improve stream habitats for Okaloosa darter and plans to continue this work indefinitely (USAF 2017, pp. 512).

All of the aforementioned threats could pose barriers to dispersal. Road crossings and impoundments, however, create the most obvious barriers, and many of these barriers have been removed. In 2011, when Okaloosa darters were downlisted to threatened status, 4 of the 153 road crossings and 25 impoundments that were barriers to fish passage remained. A few of these road crossings were culverts with the downstream end perched above the stream bed, precluding the upstream movement of fish during normal and low-flow conditions. However, some of these barriers were determined to have little to no adverse consequence to darter habitat connectivity because they occurred on the outskirts of the current range or were immediately adjacent to another barrier or impoundment.

To date, all but three of the problematic road crossings have been removed. One of these, located at the headwaters of Rocky Creek, is scheduled for removal in coming years. Additionally, 19 impoundments still exist, 11 of which are caused by beaver activity. Nine of these impoundments are scheduled for removal in the next 3 years. Beavers that remain are primarily in the headwater reaches where Okaloosa darters are either not present or would be in very low density. Thus, since the time of listing, most of the barriers to dispersal have been removed, and most of the problematic ones that remain are scheduled to be removed, contributing to improved habitat and reduced population fragmentation.

Overhead canopies range from open to fully closed depending on stream width and fire history (Jordan 2018, pers. comm.). Okaloosa darters thrive in reaches with relatively open canopies, likely due to either increased abundance of submerged vegetation that is used preferentially for spawning or increased secondary production of insect prey (Ingram 2018, p. 11). During the past 25 years, several monitored stream sections have changed from open with submerged vegetation to closed canopies with no vegetation. Closed canopy may reduce densities of Okaloosa darters. Once canopy is removed, Okaloosa darter densities increase quickly and dramatically (USFWS 2019, p. 30). In addition to increased riparian density along the streams, the use of low-intensity fire for forest management as opposed to historically high-intensity wildfires could have cascading effects on the watershed through changes in nutrient cycling, hydrology (evapotranspiration), or simply charcoal buffering (changes in pH levels) of water chemistry in the creeks. The Eglin AFB fire management program may shift toward the use of higher intensity prescribed fires in the growing season along stream margins to control growth of canopy trees.

The introduction and colonization by nonnative invasive species that could compete with or prey on Okaloosa darters is a potential threat. The Okaloosa darter recovery plan lists competitive exclusion by the then-thought-to-be invasive brown darter (Etheostoma edwini) to be a threat to Okaloosa darters. The brown darter is native to Okaloosa darter watersheds (Austin, unpublished data) and is not altering the distribution or abundance of Okaloosa darters where they coexist (USFWS 2019, p. 23). Flathead catfish (Pylodictus olivaris) are already present in the surrounding river systems, and conditions could become suitable for several cichlid species to successfully reproduce in Okaloosa darter habitat (Jelks 2018, pers. comm.). Tilapia (Oreochromis niloticus), for instance, are highly invasive and are well documented to cause local extinctions of native species through resource competition, predation, and habitat alteration (Canonico et al. 2005, pp. 467-474; Zambrano et al. 2006, pp. 1906-1909). Release of aquarium species also remains a possibility. While this threat is speculative and dependent on an intentional release of an unknown invasive species, introduction of a highly competitive predator could lead to severe population depression or potential extirpation of Okaloosa darters. Dispersal of an invasive species among Okaloosa darter's watersheds, however, would likely be limited by saltwater, giving managers time to take control measures within a single population. Eglin AFB and Service personnel have long-established invasive species monitoring programs, and both agencies are committed to routine monitoring, early detection, and control of aquatic invasive species. Early detection and targeted management of invasive species will minimize or eliminate this threat to Okaloosa darters in the future (Tate 2019, pers. comm.).

The vast majority of the range of Okaloosa darters is located on Eglin AFB, where many conservation and restoration actions have been successful in restoring Okaloosa darters to regions it had previously been extirpated from and increasing darters densities since the time of listing. Much progress has been made in implementing conservation actions since the Okaloosa darter was downlisted to threatened. For example, Eglin AFB has restored more than 534 acres of erosional sites and completed multiple stream restoration projects to reconnect fragmented populations. Stream erosion levels have been reduced, and most of the fish passage barriers have been removed. Many restoration projects have been completed, and conservation agreements have been implemented. Collectively, the habitat restoration programs have restored Okaloosa darter habitat, and management agreements will secure the habitat into the future (USAF 2017, p. 94 Wetland Sciences 2011, entire).

However, portions of the Okaloosa darter's range still face threats, mostly from urbanization. The sedimentation, pollution and water quality impacts, and changes to water flow from impoundments that can result from urbanization can lead to a decrease in Okaloosa darters. In areas where there is development, either on Eglin AFB main base or the surrounding cities, darters decrease in abundance or disappear (USFWS 2019, p. 23). Darters also still face threats from canopy closure, accidental spills, or other severe events. However, the vast majority of the Okaloosa darter's range is expected to remain under the management of the Air Force, limiting the impacts from urbanization to less than 10 percent of the historical range for the species.

Okaloosa darters react quickly to restoration activities. For instance, erosion control and other restoration activities began earlier in the Boggy Bayou drainages, progressing to the Rocky Bayou drainages (Pizzalato 2018, pers. comm.). Accordingly, darter numbers increased in the Boggy Bayou drainages earlier than in the Rocky Bayou drainages (Jordan and Jelks 2018, p. 9). Okaloosa darters have also been shown to quickly recolonize restored streams (Reeves et al. 2016, entire) and reclaimed beaver impoundments (Nicholson 2009, entire).

We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have not only analyzed individual effects on the species, but we have also analyzed their potential cumulative effects. We incorporate the cumulative effects into our SSA analysis when we characterize the current and future condition of the species. To assess the current and future condition of the species, we undertake an iterative analysis that encompasses and incorporates the threats individually and then accumulates and evaluates the effects of all the factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative effects analysis.

For Okaloosa darters to maintain viability and withstand stochastic disturbance events, its populations must be sufficiently resilient, which is associated with population size, growth rate, and habitat quality. Stochastic events that have the potential to affect Okaloosa darter include temperature changes, drought, localized pollutants/contaminants or other disturbances, or severe weather events such as hurricanes, which can impact individuals or the habitat they require for critical life functions such as breeding, feeding, and sheltering.

Sufficiently resilient Okaloosa darter populations need quality habitat. Okaloosa darters require clear, clean, flowing water provided by deep layers of sand that regulate temperature and flow, with aquatic vegetation, root mats, leaf snags, and other substrates that provide cover. This habitat is maintained by land management practices on adjacent land that limit sedimentation and pollution. Streams that support Okaloosa darter should be free of impoundments created as human-made retention ponds, by poorly designed road crossings that impede flow and genetic exchange, or by beaver dams. Okaloosa darter also benefit from open riparian canopies that allow sunlight to reach the stream below (Ingram 2018, p. 11).

For analysis purposes, we delineated resiliency units for Okaloosa darters based on genetic analysis and obvious barriers to dispersal. Genetic variation exists between the six stream systems (Austin et al. 2011, p. 987). Because limited genetic exchange occurs between streams, the population in each stream is likely to be demographically independent; therefore, we used abundance data for each of the six stream systems to assess resiliency.

Additionally, we assessed barriers to dispersal within each stream system that would indicate a further breakdown into additional populations. However, Eglin AFB has been effective in removing impoundments and poorly designed road crossings that served as barriers to dispersal, so that the remaining impoundments occur at the headwaters or the lower reaches of each stream, leaving each stream's population mostly intact, allowing genetic exchange to occur within each stream system. Outside of Eglin AFB, Shaw Still Branch has Okaloosa darter that are isolated from other Okaloosa darter in the upper reaches of Swift Creek by College Pond; however, the numbers of darters in this small stream are likely fewer than 150. Therefore, we considered this population separately. The watersheds of each of the bayous (Toms, Boggy, and Rocky) where the species has been historically found constitute the three resiliency units for the purposes of this analysis. The Toms representative unit consists only of the Toms population; the Boggy unit consists of the Turkey and Mill populations; and the Rocky unit consists of the Swift, Deer, and Rocky populations.

Habitat metrics, such as conductivity, other water quality metrics, and management, influence darter presence and abundance, but due to a lack of explained variation within the data, no quantitative predictive model has been successfully used. However, numerous data exist that draw causal relationships between habitat metrics and darter presence and abundance, such that we can draw some conclusions. First, it is clear that Okaloosa darter does not inhabit impounded stream reaches. Further, when an impounded stream is restored, Okaloosa darter will quickly colonize the restored habitat, often at higher densities than initially found (Jordan and Jelks 2018, p. 29). When water conductivity gets too high, Okaloosa darter abundance drops (Service 2019, p. 33).

We assess current resiliency for Okaloosa darters in terms of population factors, including the species' presence and density. To estimate a population size, we multiplied the estimated average abundance per meter by the estimated meters occupied (USFWS 2019, Table 5). The average abundance was derived from annual sampling at each of the 21 core monitoring sites over the past 20 years. In populations with multiple core sites, a grand mean was calculated for the entire population by averaging the long-term means within the population. Due to statistical constraints, population estimates using the expanded monitoring data from 2005 and 2014 only estimate the population of darters present in stream reaches between monitoring sites (USFWS 2019, p. 23) and do not include headwaters and tributary systems known to be inhabited. The calculations made during the SSA and used for this assessment apply the average abundance to all known inhabited stream reaches, generally producing a larger but more complete population estimate.

Using this method, the total rangewide population estimate of Okaloosa darter is approximately 1,249,499 (1,010,0171,488,982) (see Table 1, below). The Rocky Creek population is the largest, comprising 713,458 darters, or 57 percent of this total, followed by the Turkey Creek population, comprising 490,456 darters, or 39 percent. The other four resiliency units (Toms, Mill, Swift, and Deer Moss) together total only four percent of the estimate: Toms Creek has an estimated 23,099 darters; Mill Creek, 1,317; Swift Creek, 18,810; and Deer Moss Creek, 2,353.

These numbers reflect a significant (40 percent) decline between 2005 and 2014. However, the population is still significantly greater than when the species was originally listed. Our professional judgment is that the reduction was caused by an increase in the canopy cover and that more aggressive clearing of the canopy cover will result in rebounding population numbers. This conclusion is consistent with experimental data, in which darter populations increased within months after canopy removal.

The results of the resilience analysis are as follows: Two of the populations (Turkey and Rocky) currently have high resiliency, two (Toms and Swift) are considered moderately resilient, and two (Deer Moss and Mill) are considered to have low resiliency.

We classified resiliency by species' presence, density, and population sizes. Population sizes of <10,000 Okaloosa darters are considered “low,” 10,000 to 50,000 are “moderate,” and >50,000 are “high.” Based on the population numbers presented above, the results of the resiliency analysis are as follows: Two of the populations (Turkey and Rocky) currently have high resiliency, two (Toms and Swift) have moderate resiliency, and two (Deer Moss and Mill) are considered to have low resiliency.

Redundancy describes the ability of a species to withstand catastrophic events. Measured by the number of populations, their resiliency, and their distribution (and connectivity), redundancy gauges the probability that the species has a margin of safety to withstand or to bounce back from catastrophic local events such as collapse of a restored borrow pit, infestation by beavers, or spill of toxic chemicals that affect part or all of one population. We report redundancy for Okaloosa darters as the total number of populations and the resiliency of population segments and their distribution within and among representative units. Also, there are multiple populations in two of the stream systems.

Six populations comprise the vast majority of the historical range of Okaloosa darters within the three representative units. Redundancy is demonstrated through the darter's presence in multiple tributaries within most watersheds, and representation is demonstrated through the genetic structure of the populations. All six extant populations exhibit genetic differentiation, and the species is extant across all three representation units. Adequate redundancy is demonstrated through the darter's presence in multiple tributaries within most watersheds encompassing its historical range.

Representation can be characterized by genetic variability within the range of the species. These three representative units, each identified as containing unique and significant historical variation (Austin et al. 2011, pp. 983, 987), have not been reduced over time. The Toms Bayou representative unit comprises just the Toms population, which is currently considered moderately resilient. However, the Toms population is vulnerable to upstream impacts, which could affect the representation of this unit were a major impact to occur. The Boggy Bayou representative unit comprises the Turkey and Mill populations, of which Turkey is considered highly resilient and has low vulnerability. The Rocky Bayou unit comprises the Swift, Deer Moss, and Rocky populations, of which Swift is considered moderately resilient and Rocky is considered highly resilient, with low vulnerability. Given that each unit still contains at least one population that is moderately or highly resilient (>10,000 individuals), Okaloosa darters have sufficient genetic variability. Representation is demonstrated through the genetic structure of the populations.

The biggest potential threat to Okaloosa darter in the future is development on and off Eglin AFB. Neighborhoods, roads, commercial structures, and associated utilities such as sprayfields are potential sources of sedimentation, pollution, and altered stream flow throughout the range of this species. Natural factors resulting from long-term forest management practices ( e.g., prescribed fire) could also have potentially negative impacts on Okaloosa darters. For instance, excessive canopy closure over streams might limit Okaloosa darter abundance by shading out aquatic vegetation preferred for spawning, refuge, or foraging (USFWS 2019, p. 23). The effects of canopy closure were built into all the future scenarios through general population increases or declines. For instance, in the “Ideal Management” scenario, we would expect that prescribed fire or other management limits excessive canopy cover and contributes to increases in darter numbers. The opposite would be expected in the “Poor” and “Worst” scenarios. Because we have not established a quantitative relationship between darter numbers and canopy closure, we decided to incorporate this factor into a general increase or decrease in populations over time.

While there are several restoration activities, developments, or other proposed activities that have anticipated locations and quantifiable outcomes, specific information on the location, and therefore effects to Okaloosa darters, of other potential threats are unknown. Therefore, because it is impossible to predict the specific locations or impacts of future developments or other management decisions that could impact Okaloosa darter streams, we assess the future resiliency of each population based on general management and development scenarios. Accordingly, to assess the future viability of Okaloosa darters, we considered four future scenarios that account for some degree of future development and restoration activities, considering effects of whether these activities are implemented or not, and also considered general impacts from unknown future management or land use changes or impacts, at varying levels with positive or negative impacts to each population. For each population, we consider its current condition, including the length of each stream that is unimpounded, the length considered occupied, and the average abundance per meter, to assess the future viability under each of these scenarios.

Please see the SSA report (USFWS 2019, entire) for a more detailed discussion of these considerations.

We projected these future scenarios both over 20 years and 50 years. Any planned restoration efforts, should they be realized, as well as the impending development along Deer Moss Creek, would likely be completed in 20 years. Okaloosa darters respond very quickly to habitat changes, both good and bad. Improved conditions would result in an increase in Okaloosa darters, possibly within the same year (Reeves et al. 2016, pp. 1379-1382), but areas can also lose Okaloosa darters equally quickly if habitat conditions worsen. In some cases where habitat is restored in areas without nearby Okaloosa darters, 20 years would be sufficient to ensure that they would recolonize that area. Not only would 20 years encompass several generations of Okaloosa darter, but it is the time period outlined in the recovery plan for delisting. We projected to 50 years as it is considered the outer limit that projections of base realignment, hydrologic cycles, or climate alteration may be relied upon, based on expert opinion, and will encompass a timeframe in which projected sea level rise as a result of climate change could have realized impacts.

To account for the uncertainty in the management implications of some proposed actions (Deer Moss Creek development and cleanup of the sprayfields) and other unforeseen/unknown future conditions (future land management/development and accidents), we generalize the future stream conditions/management in four categories: status quo (current conditions continue), ideal, poor, and worst. The “ideal,” or “best-case,” scenario assumes that all potential stream habitat is colonized at normal densities. “Poor” management assumes that accidents stemming from errors in management may occur but are unlikely to affect the population in the worst possible place or are unlikely to have a high-magnitude impact; however, over time, these accidents add up and eventually have a larger impact. “Worst” management assumes that accidents stemming from errors in management occur and affect the population in a location that will affect the largest portion of the stream or will be of such a magnitude to have a similar effect. In all long-term scenarios, we anticipate the potential negative impacts of climate change by applying reductions in population estimates of 0.5 standard deviations from the current population mean abundance.

Below we assess the future resiliency of Okaloosa darter populations both in the short (20-year) and long term (50-year) for the four different scenarios. Of the four scenarios, the status quo and the ideal scenario are the most likely to occur. The poor and worst management are the least likely to occur. Because these four scenarios encompass the broad changes to management, which would encompass water quality and render land ownership irrelevant, we model future resiliency based on how each scenario would affect the amount of occupied habitat and average abundance estimates within each population. Please see the SSA report for further description of the methodologies we used to model these scenarios and their impacts to Okaloosa darter.

In this scenario, we modeled current management coupled with both no restoration efforts (1a) and with restoration of the beaver dams on Toms Creek and College Pond on Swift Creek (1b). Under scenario 1a, nothing changed by way of management or restoration, meaning the impounded stream and abundance estimates stayed the same as is current. The development of Deer Moss Creek did not affect the resiliency of this population because the section of stream that would be developed is currently, and remains, unoccupied. For the species as a whole, population estimates did not change much in the short term but decreased in the long term due to a loss of potential habitat (due to sea level rise resulting in stream inundation) and other possible climate-related threats, which we modeled as a 0.5 standard deviation reduction for each population. Not surprisingly, the smallest and most fragmented populations, Mill, Deer Moss, Toms, and Swift Creeks, are potentially susceptible to climate change impacts alone. Habitat restoration in Toms and Swift Creeks would offset our modelled impacts from climate change. Even though saltwater inundation will fragment about 5 percent of the two large populations in Turkey and Rocky Creeks, our models exhibited minimal loss of resiliency as a result of climate change under this scenario.

For the species as a whole, our modelling suggested that, under current management conditions, there are likely to be nearly 1 million Okaloosa darters beyond the 50-year timeframe. In the long term under this scenario, Mill Creek would lose over 30 percent of its population (dropping below 1,000), as would Deer Moss, and Toms Creek too, unless restoration occurs. Swift Creek would lose almost 60 percent of its population unless habitat restoration occurs, but if restoration occurs, the population would more than double in the short term and still increase by nearly 60 percent in the long term. Saltwater inundation in the long term would cause the Rocky, Turkey, and Swift populations to split into three streams each. While Rocky and Turkey would see about 5 percent of their populations cut off from the main segment, the inundation of Swift Creek would also cut off that population from the current location in the absence of restoration efforts. With no restoration, we can expect that 70 percent of the population in Swift Creek will be above College Pond in Swift Creek, with fewer than 100 in Shaw Still Branch, although neither of these populations are unlikely to remain at all in 50 years. With restoration, about 83 percent of the population would remain in the Swift Creek population and about 17 percent in a Shaw Still Branch population, with likely no dispersal between them (see Table 2, below). Due to the continued impacts of the urbanization in the watershed within the city of Niceville, we estimated population sizes as if inhabited under moderate management conditions (long-term average minus one standard deviation). Sanders Branch would remain unoccupied.

This scenario represented the highest population size that the species could attain. Under this scenario, all impoundments were removed, and management removed most existing threats, increasing the occupied lengths of each stream to almost all of the inhabitable area. In other words, we modelled the potential population for all streams as if they were completely free-flowing by applying our current population estimates to the entire potential length of stream habitat in the watershed. This scenario represented the “best case scenario” for the species. Because of this, we modelled an expected population expansion of 1.0 standard deviation from the current mean abundance for each population. As expected, short-term estimates increased for all populations, with the highest relative increases in fragmented populations (Swift and Toms) or those impaired by urbanization (Deer Moss and Mill). Because we apply the same negative influence of climate change to the long-term models in this scenario, the long-term population estimates are dampened but still increasing in the four smaller populations with a very slight (<1 percent) reduction in Turkey and Rocky Creeks due to fragmentation and saltwater inundation. Under this scenario, our model indicated there will be more than 1.3 million Okaloosa darters and increased resiliency in all of the smaller populations, even when negative impacts of climate change are applied in the long term.

In the short term, the population would increase for all stream systems, although by a much higher percent in Mill and Swift than in Rocky and Turkey Creeks. In the long term, all populations except Turkey and Rocky still see an increase from current conditions, though not quite as large. Turkey and Rocky would decrease slightly from the current situation (see Table 3, below). Saltwater inundation in the long term would cause the Rocky, Turkey, and Swift stream systems to split into three streams each. While Rocky and Turkey would see about 5 percent of their populations cut off from the main segment, the inundation of Swift Creek in the long term, given ideal restoration and management, would split the population such that about 15 percent would be cut off into a Shaw Still Branch population, and about 11 percent would be cut off into a Sanders Branch population.

To model what the future effect of poor management decisions, developments, or other habitat impacts would be in terms of a decrease in average Okaloosa darter abundance per meter, we considered the configuration (or geography) of each stream system for each population. In streams that are complex (have many branching tributaries) or are generally large, a severe negative impact (such as a chemical spill or source of chronic sedimentation) at any of the headwaters would be more likely to impact a smaller percentage of the population compared to a similar impact in the headwaters of a low-complexity (few tributaries) or small stream system. For scenarios 3 and 4, we first assessed the effects of an impact that might occur at the worst possible placement within each watershed by finding the longest length of stream that could be affected by a major impact at the headwaters; in other words, the longest possible downstream distance that could be affected by a single upstream impact. We calculated this distance for each stream (USFWS 2019, Figure 14) and then took that distance and calculated the percent of the total unimpounded streams it would affect (USFWS 2019, Table 7). This percent represents the maximum percent of the stream system that could be affected by one management decision or development. In real-world terms, if one of the outlying airfields that are located in the upper reaches of these stream systems (USFWS 2019, Figure 14) were to be reactivated for military or other uses, the amount of stream impacted could come close to or meet these estimates of “largest percent affected.”

For both the “Poor” and “Worst” management scenarios, we used this “largest percent affected” to model declines in Okaloosa darter abundances based on whether management was considered “poor” or “worst,” and whether we were assessing the scenario in the long or short term (USFWS 2019, Table 8).

For management that was “poor,” looking at the short term, we considered a management decision or set of decisions or impacts that would decrease the average abundance by 1 standard deviation across this “largest percent affected” (this percent of the occupied meters). The remainder of the occupied stream length stayed at current Okaloosa darter abundances. In the long term, we proposed that management impacts could continue to affect these streams either in unfortunate locations or in great magnitude and, coupled with unknown impacts of climate change and the associated warming over that time span, will decrease all abundance estimates an additional 0.5 standard deviation (USFWS 2019, Table 8). As with “Status Quo,” we modeled poor management coupled with either no restoration efforts or removal of beaver dams on Toms Creek and restoration of College Pond on Swift Creek.

Under this scenario (see Table 4, below), all population sizes decreased. In the long term, the Swift population dropped below 10,000 individuals unless College Pond is restored, in which case the population almost doubled in the short term and still maintained 15 percent more than current in the long term. In the long term, the Swift Creek population dropped below 10,000 individuals without restoration, and the populations in both Deer Moss and Mill Creeks dropped below 1,000 individuals. Even so, long-term resiliency in Toms, Turkey, Swift, and Rocky Creeks remained relatively unchanged from the “Status Quo” models.

This scenario is very pessimistic. We considered a management decision or set of decisions or impacts that would decrease the average abundance by 2 standard deviations across the “largest percent affected,” described above. The remainder of the occupied stream length in Scenario 4 was then considered to be occupied at the “poor” Okaloosa darter abundances (a reduction of 1 standard deviation). As with other scenarios, we modeled climate change impacts as an additional reduction of 0.5 standard deviations from the long-term mean and considered the impact of restoration in Toms and Swift Creeks in a separate model.

This is the only scenario where we modelled an extirpation. All populations were reduced by at least 20 percent, even in the short term (see Table 5, below). Under this scenario, Mill and Deer Moss Creek dropped below 1,000 individuals in the short term, and Deer Moss Creek became extirpated in the long term. We estimated a population decline in Toms Creek to approximately half the population estimate of the “Status Quo” scenario. Our model projected that Swift Creek could drop to approximately one quarter the population anticipated under the “Status Quo”; however, the restoration of College Pond would prevent this population from dropping below 10,000 individuals in the short term and more than quadruple the population estimate in the long term. The Turkey and Rocky populations would maintain high resiliency, above 300,000 individuals, even in the long term.