This final rule, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement No. 125 and Marketing Order No. 966, as amended (7 CFR part 966), regulating the handling of tomatoes grown in Florida. Part 966 is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the marketing order and is comprised of producers operating within the production area.

The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this final rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled ‘Reducing Regulation and Controlling Regulatory Costs’ ” (February 2, 2017).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This final rule amends the Florida tomato districts and reapportions membership on the Committee as prescribed under the marketing order for the 2020-21 and subsequent fiscal periods. This final rule will reduce the number of districts from four to two and reapportion producer membership on the Committee to provide equitable representation from both districts. Redistricting and reapportionment of membership will make it easier for Committee staff to conduct producer nominations and ensure the appointment of a full Committee. A fully appointed Committee will make it easier to achieve a quorum for assembled meetings. The Committee unanimously recommended this change at its November 1, 2018, meeting.

Section 966.22 provides for the establishment of membership on the Committee. The 12 members and their alternates shall be producers, or officers or employees of a corporate producer, in the district for which selected and a resident of the production area. The marketing order provides districts from which producers serve as representatives on the Committee.

Section 966.25 provides the authority for the Committee to recommend, with the approval of the Secretary, reapportionment of members among districts, and the reestablishment of districts within the production area. This section also provides that, in making such recommendations, the Committee shall give consideration to: (a) Shifts in tomato acreage within districts and within the production area during recent years; (b) the importance of new production in its relation to existing districts; (c) the equitable relationship of Committee membership and districts; (d) economic results for producers in promoting efficient administration due to redistricting or reapportioning members within districts; and (e) other relevant factors.

Section 966.24 defined the four districts within the production area by county. Districts 1 and 2 have previously been reestablished pursuant to § 996.160. Section 966.161 apportions Committee membership among the districts pursuant to § 966.25. Currently, Districts 1 and 2 are represented by two Committee members and alternates each and Districts 3 and 4 are represented by four Committee members and alternates each.

The Committee met on November 1, 2018, to discuss the changes in recent years to production and the shift in acreage location of Florida tomatoes. Over the past two decades, the Florida tomato industry has experienced significant changes in production volume and location. Decreasing production and shifts in acreage are due to increased production costs along with competition from imports and other growing regions. The increased costs and competition has contributed to a decrease in the number of producers and handlers. With fewer producers to represent the industry and the changes to production and acreage, the Committee discussed redistricting and reapportioning its membership.

Tomato production has shifted from the eastern part of the production area in Florida (Districts 1 and 2) to the western part of the production area (Districts 3 and 4). According to Committee data, production during the 2017-18 season in District 4 accounted for 56 percent of the production area's total production. The next largest district by production volume was District 3, accounting for 39 percent of total production. In comparison, District 1 accounted for 4 percent of total production and District 2 only 1 percent of the total volume for the production area.

According to Committee data, Districts 1 and 2 accounted for 28 percent of total production during the 1998-99 season but production had decreased to only 8 percent by the 2007-08 season. Industry production has slowly moved into Districts 3 and 4 over the last 20 years and now these two districts make up 95 percent of total production.

The shift in tomato production between districts has created an imbalance in Committee representation. The members from Districts 1 and 2 combined represent one-third of the membership on the Committee while these districts account for only 5 percent of the tomato production volume. Consequently, Districts 3 and 4 are underrepresented with only two-thirds of the Committee membership. During the discussion, Committee members reviewed acreage and production data from all districts in the production area as required in the marketing order. The gradual shift in acreage and production from the eastern portion of the production area in Florida to the western portion has made it difficult to find enough qualified producers to represent Districts 1 and 2 on the Committee. Committee members from these two districts represent four seats on the Committee. Committee members also noted that with fewer producers remaining in the Florida tomato industry, particularly in Districts 1 and 2, it is difficult to get enough members together to satisfy the marketing order's quorum requirements for a meeting.

As a result of the discussion and analysis, the Committee recommended combining the current Districts 1, 3, and a portion of District 2 into one district, and District 4 and the remaining portion of District 2 into another district. This change will divide the production area into two districts with each district representing approximately half of the total volume of tomatoes produced in the production area. The Committee also recommended reapportioning the 12 Committee members and alternates so that six Committee members and alternates represent each district.

The two new districts will encompass the following Florida counties: District 1 will include the counties of Charlotte, Glades, Palm Beach, Lee, Hendry, Collier, Broward, Monroe, and Dade; and District 2 will include the counties of Pinellas, Hillsborough, Polk, Osceola, Brevard, Manatee, Hardee, Highlands, Okeechobee, Indian River, St. Lucie, Sarasota, De Soto, and Martin.

The Committee unanimously voted to reduce the number of districts from four to two and reapportion producer membership on the Committee so that each district will have six members and alternates. The Committee believes these changes will adjust producer representation to reflect the composition of the industry, and create the opportunity for other producers to serve on the Committee.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 75 producers of Florida tomatoes in the production area and 37 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to industry and Committee data, the average annual price for fresh Florida tomatoes during the 2017-18 season was approximately $12.56 per 25-pound container, and total fresh shipments were 25.9 million containers. Using the average price and shipment information, the number of handlers, and assuming a normal distribution, the majority of handlers have average annual receipts of more than $7.5 million, ($12.56 times 25.9 million containers equals $325.3 million divided by 37 handlers equals $8.79 million per handler).

With an estimated producer price of $6.00 per 25-pound container, the number of Florida tomato producers, and assuming a normal distribution, the average annual producer revenue is above $750,000, ($6.00 times 25.9 million containers equals $155.4 million divided by 75 producers equals $2.07 million per producer). Thus, the majority of handlers and producers of Florida tomatoes may be classified as large entities.

The gradual shift in acreage and production from the eastern portion of the production area in Florida to the western portion has made it difficult to find enough qualified producers to represent Districts 1 and 2 on the Committee. Committee members from these two districts represent one-third of the seats on the Committee. Redistricting and reapportionment of membership will make it easier for Committee staff to conduct producer nominations, provide nominees for all seats, and readily achieve a quorum when meetings are assembled with a full complement of members.

This final rule will reduce the number of districts from four to two and reapportion producer membership on the Committee to provide six members and alternates from both districts. The Committee believes these changes will adjust producer representation to reflect the composition of the industry, provide equitable representation from each district, and create the opportunity for other producers to serve on the Committee. This rule revises §§ 966.160 and 966.161. Authority for this action is provided in § 966.25 of the marketing order.

It is not anticipated that this action would impose any additional costs on the industry. These changes will save time and operating resources by making it easier to find candidates to serve on the Committee. Additionally, a full Committee will reduce the chance of a failed quorum. Thus, this action will help avoid the costs associated with travel and assembly of a meeting where a quorum is not achieved.

This action is expected to have a beneficial impact as it more accurately aligns districts and reapportions Committee membership in accordance with the production of fresh Florida tomatoes. These changes should provide equitable representation to producers on the Committee and make the Committee more representative of the current industry. The effects of this rule will not be disproportionately greater or less for small entities than for larger entities.

The Committee considered an alternative to this action. The Committee considered combining Districts 1 and 2 into one district. However, given the small volume of production currently produced in each of these districts, the Committee determined the best course of action was to divide the production area into two new districts with balanced production and representation. Therefore, this alternative was rejected.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the marketing order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178 Vegetable and Specialty Crops. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This final rule will not impose any additional reporting or recordkeeping requirements on either small or large Florida tomato handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. No public comments were received regarding the initial regulatory flexibility analysis.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

The Committee's meetings were widely publicized throughout the Florida tomato industry, and all interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the November 1, 2018, meeting was a public meeting, and all entities, both large and small, were able to express their views on this issue.

A proposed rule concerning this action was published in the Federal Register on April 24, 2019 (84 FR 17091). Copies of the proposed rule were sent via email to Committee members and Florida tomato handlers. Additionally, the rule was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending May 24, 2019, was provided to allow interested persons to respond to the proposal. No comments were received. Accordingly, no changes will be made to the rule as proposed.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses . Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant matter presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

For the reasons set forth in the preamble, 7 CFR part 966 is amended as follows:

This action, pursuant to 5 U.S.C. 553, finalizes amendments to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 981, as amended (7 CFR part 981), regulating the handling of almonds grown in California. Part 981 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” Section 608c(17) of the Act and the applicable rules of practice and procedure governing the formulation of marketing agreements and orders (7 CFR part 900) authorizes amendment of the marketing order through this informal rulemaking action.

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This action has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of entry of the ruling.

Section 1504 of the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill)(Pub. L. 110-246) amended section 608c(17) of the Act, which in turn required the addition of supplemental rules of practice to 7 CFR part 900 (73 FR 49307; August 21, 2008). The amendment of section 608c(17) of the Act and additional supplemental rules of practice authorize the use of informal rulemaking (5 U.S.C. 553) to amend Federal fruit, vegetable, and nut marketing agreements and orders. USDA may use informal rulemaking to amend marketing orders based on the nature and complexity of the proposed amendments, the potential regulatory and economic impacts on affected entities, and any other relevant matters.

The USDA's Agricultural Marketing Service (AMS) considered these factors and determined that amending the Order as proposed could appropriately be accomplished through informal rulemaking.

The proposed amendments were unanimously recommended by the Board following deliberations at a public meeting held on December 4, 2017. A proposed rule soliciting comments on the proposed amendments was issued on July 2, 2018, and published in the Federal Register on July 6, 2018 (83 FR 31473). One comment was received, but it did not pertain to the proposal; therefore, no changes were made to the proposed amendments. A proposed rule and referendum order was then issued on November 7, 2018, and published in the Federal Register on November 14, 2018 (83 FR 56742). This document directed that a referendum among almond producers be conducted March 25, 2019, through April 5, 2019, to determine whether they favored the proposals. To become effective, the amendments had to be approved by two-thirds of eligible producers voting in the referendum or more than two-thirds of the volume represented in the referendum.

The three amendments were favored by at least 82 percent of the producers voting and by at least 89 percent of the volume represented, all of which exceed the requirements to pass.

The amendments in this final rule will change the dates associated with the Board's nomination process, modify the term of office start date for Board members, and add authority for future revisions to these provisions through the development of regulations using informal rulemaking.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 6,800 almond growers in the production area and approximately 100 almond handlers subject to regulation under the Order. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).

The National Agricultural Statistics Service (NASS) reported in its 2012 Agricultural Census that there were 6,841 almond farms in the production area (California), of which 6,204 had bearing acres. The following computation provides an estimate of the proportion of agricultural producers (farms) and agricultural service firms (handlers) that would be considered small under the SBA definitions.

The NASS Census data indicate that out of the 6,204 California farms with bearing acres of almonds, 4,471 (72 percent) have fewer than 100 bearing acres.

For the almond industry's most recently reported crop year (2016), NASS reported an average yield of 2,280 pounds per acre and a season average grower price of $2.44 per pound. A 100-acre farm with an average yield of 2,280 pounds per acre would produce about 228,000 pounds of almonds. At $2.44 per pound, that farm's production would be valued at $556,320. The Census of Agriculture indicates that the majority of California's almond farms are smaller than 100 acres; therefore, it could be concluded that the majority of growers had annual receipts from the sale of almonds in 2016-17 of less than $556,320, which is below the SBA threshold of $750,000. Thus, over 70 percent of California's almond growers would be classified as small entities according to SBA's definition.

To estimate the proportion of almond handlers that would be considered small businesses, it was assumed that the unit value per shelled pound of almonds exported in a particular year could serve as a representative almond price at the handler level. A unit value for a commodity is the value of exports divided by the quantity. Data from USDA's Foreign Agricultural Service showed that the value of almond exports from August 2016 to July 2017 (combining shelled and inshell almonds) was $4.072 billion. The quantity of almond exports over that period was 1.406 billion pounds, combining shelled exports and the shelled equivalent of inshell exports. Dividing the export value by the quantity yields a unit value of $2.90 per pound. Subtracting this figure from the NASS 2016 estimate of season average grower price per pound ($2.44) yields $0.46 per pound as a representative grower-handler margin. Applying the $2.90 representative handler price per pound to 2016-17 handler shipment quantities provided by the Board showed that approximately 40 percent of California's almond handlers shipped almonds valued under $7,500,000 during the 2016-17 crop year and would therefore be considered small entities according to the SBA definition.

These amendments, which the Board unanimously recommended on December 4, 2017, will change the dates associated with the Board's nomination process, modify the term of office start date for Board members, and add authority for future revisions to these provisions through the development of regulations using informal rulemaking.

These amendments will have no direct economic effect on producers or handlers. Due to changes in the industry, the amendments are necessary to ensure the Board's ability to locally administer the program. Changing nomination dates, modifying term of office, and adding authorizing for future revisions will enable the Board to ensure a more efficient and orderly flow of business. It is anticipated that both small and large producer and handler businesses will benefit from these amendments.

The Board considered alternatives to the proposals, including making no changes at this time. However, this action will streamline the Order's operation by aligning Board membership with the beginning of the crop year. There will be no change to the composition of the Board.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops). No changes to those requirements are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

The Board's meeting was widely publicized throughout the almond production area. All interested persons were invited to attend the meeting and encouraged to participate in Board deliberations on all issues.

A proposed rule concerning this action was published in the Federal Register on July 6, 2018 (83 FR 31473). Copies of the proposed rule were sent via email to all Board members and almond handlers. It was also made available through the internet by USDA and the Office of the Federal Register. A 60-day comment period ending September 4, 2018, was provided to allow interested persons to respond to the proposal. One comment was received, but it did not pertain to this proposal; therefore, no changes were made to the proposed amendments.

A proposed rule and referendum order was then issued on November 7, 2018, and published in the Federal Register on November 14, 2018 (83 FR 56742). This document directed that a referendum among almond producers be conducted March 25, 2019, through April 5, 2019, to determine whether they favored the proposals. To become effective, the amendments had to be approved by two-thirds of eligible producers voting in the referendum or by more than two-thirds of the volume represented in the referendum.

All three amendments were favored by at least 82 percent of the producers voting and at least 89 percent of the volume represented, all of which exceed the requirement to pass.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses . Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

(a) Findings and Determinations Upon the Basis of the Rulemaking Record.

The findings hereinafter set forth are supplementary to the findings and determinations which were previously made in connection with the issuance of the Order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.

1. The Order, as amended, and as hereby further amended, and all of the terms and conditions thereof, would tend to effectuate the declared policy of the Act;

2. The Order, as amended, and as hereby further amended, regulates the handling of almonds grown in California in the same manner as, and is applicable only to, persons in the respective classes of commercial and industrial activity specified in the Order;

3. The Order, as amended, and as hereby further amended, is limited in application to the smallest regional production area that is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;

4. The Order, as amended, and as hereby further amended, prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of almonds produced in the production area; and

5. All handling of almonds produced in the production area as defined in the Order is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.

(b) Determinations.

It is hereby determined that:

1. Handlers (excluding cooperative associations of producers who are not engaged in processing, distributing, or shipping of almonds covered under the Order) who during the period August 1, 2017, through July 31, 2018, handled not less than 50 percent of the volume of such almonds covered by said Order, as hereby amended, have signed an amended marketing agreement; and

2. The issuance of this amendatory Order, further amending the aforesaid Order, is favored or approved by at least two-thirds of the producers who participated in a referendum on the question of approval and who, during the period of August 1, 2017, through July 31, 2018, were engaged within the production area in the production of such almonds. Such producers also produced for market at least two-thirds of the volume of such commodity represented in the referendum.

3. The issuance of this amendatory Order together with a signed marketing agreement advances the interests of growers of almonds in the production area pursuant to the declared policy of the Act.

It is therefore ordered, that on and after the effective date hereof, all handling of almonds grown in California shall be in conformity to, and in compliance with, the terms and conditions of the said Order as hereby proposed to be amended as follows:

The provisions amending the Order contained in the proposed rule issued by the Administrator on July 2, 2018, and published in the Federal Register on July 6, 2018, (83 FR 31473) will be and are the terms and provisions of this order amending the marketing order and are set forth in full herein.

For the reasons set out in the preamble, 7 CFR part 981 is amended as follows:

Discussion

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A318-112, -121, and -122; A319-111, -112, -115, -131, -132, and -133; A320-214, -216, -232, -233, -251N, and -271N; and A321-211, -212, -213, -231, -232, -251N, -253N, -271N, and -272N airplanes. The NPRM published in the Federal Register on June 27, 2019 (84 FR 30637). The NPRM was prompted by reports of missing or loosened fasteners on connecting brackets of OHSC and pivoting POHSC. The NPRM proposed to require modification of the OHSC and POHSC attachments.

The FAA is issuing this AD to address loosening of the OHSC or POHSC fasteners. This condition, if not corrected, could lead to detachment of OHSC or POHSC, possibly resulting in injury to airplane occupants and/or impeding egress during an emergency evacuation.

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0069, dated March 28, 2019 (“EASA AD 2019-0069”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A318-112, -121, and -122; A319-111, -112, -115, -131, -132, and -133; A320-214, -216, -232, -233, -251N, and -271N; and A321-211, -212, -213, -231, -232, -251N, -253N, -271N, and -272N airplanes. The MCAI states:

The FAA gave the public the opportunity to participate in developing this final rule. The FAA has considered the comment received. Patrick Imperatrice indicated support for the NPRM.

The FAA reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

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

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

EASA AD 2019-0069 describes procedures for modification of the OHSC and POHSC attachments. EASA AD 2019-0069 also describes an inspection for discrepancies (additional work) and corrective actions. The inspection includes checks of the dimensions of the threaded pins against tolerances and checks for damage. Corrective actions include replacing threaded pins and nuts and repairing damage. This material 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 estimates that this AD affects 1,464 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required or optional 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 AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in our cost estimate.

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

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

(2) 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 amends 14 CFR part 39 as follows:

Discussion

The FAA received reports of two recent IFSDs on PW PW1524G-3 model turbofan engines. The first IFSD occurred on July 25, 2019 and the second IFSD occurred on September 16, 2019. These IFSDs were due to failure of the LPC R1, which resulted in the LPC R1 releasing from the LPC case and damaging the engine. LPC rotor failures historically have released high-energy debris that has resulted in damage to engines and airplanes (see Advisory Circular (AC) 39-8, “Continued Airworthiness Assessments of Powerplant and Auxiliary Power Unit Installations of Transport Category Airplanes,” dated September 8, 2003, available at rgl.faa.gov ).

Although these IFSDs occurred on PW PW1524G-3 model turbofan engines, the FAA is including PW PW1900 engines in the applicability of the AD because similarities in type design make these engines susceptible to the same unsafe condition as PW PW1500 engines. This condition, if not addressed, could result in uncontained release of the LPC R1, in-flight shutdown, damage to the engine, damage to the airplane, and loss of control of the airplane. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA reviewed Pratt & Whitney Service Bulletin (SB) PW1000G-A-72-00-0125-00A-930A-D, Issue No. 001, dated September 23, 2019, and PW SB PW1000G-A-72-00-0075-00B-930A-D, Issue No. 001, dated September 23, 2019. The SBs contain procedures for performing borescope inspections of the LPC R1 and the LPC IGV actuation system on engines that have less than 300 flight cycles since new.

The FAA is issuing this AD because it 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 AD requires initial and repetitive borescope inspections of the LPC IGV and the LPC R1 and, depending on the results of the inspections, replacement of the LPC.

The FAA considers this AD interim action. The investigation into the two recent failures on the PW PW1524G-3 model turbofan engines is on-going and the FAA may pursue further rulemaking action at a later date.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C.) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking. Similarly, Section 553(d) of the APA authorizes agencies to make rules effective in less than 30 days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule. Two PW1524G-3 model turbofan engines recently experienced failures of the LPC R1. LPC rotor failures can release high-energy debris from the engine and damage the airplane (see AC 39-8, “Continued Airworthiness Assessments of Powerplant and Auxiliary Power Unit Installations of Transport Category Airplanes,” dated September 8, 2003).

Both failures of the LPC R1 occurred at low flight cycles since new (154 and 230 flight cycles). The manufacturer has recommended that these inspections occur within the next 50 flight cycles and the FAA has adopted that recommendation. Based on current operational usage of the affected airplanes, 50 flight cycles equates to approximately 7 to 10 operating days. Therefore, the FAA has determined that low flight cycle rotors require inspections within the next 50 flight cycles from the effective date of this AD to prevent LPC R1 failures. Because of the need for operators to begin the required inspections within 50 flight cycles, the FAA has made this AD effective upon publication in the Federal Register . Accordingly, the FAA determined that the risk of operation of the affected engines without initial and repetitive inspections of the LPC IGV and the LPC R1 is unacceptable.

The FAA considers the need for initial and repetitive inspections of the LPC IGV and the LPC R1 to be an urgent safety issue. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the reasons stated above, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2019-0771 and Product Identifier 2019-NE-27-AD at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this final rule.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 18 engines installed on airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

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

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

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

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

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

(2) Will not affect intrastate aviation in Alaska.

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

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0233R1, dated November 28, 2018 (“EASA AD 2018-0233R1”) (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A319 series 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. You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-0250.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2015-17-14, Amendment 39-18247 (80 FR 52182, August 28, 2015) (“AD 2015-17-14”). AD 2015-17-14 applied to all Airbus SAS Model A319 series airplanes; Model A320-211, -212, -214, -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 April 24, 2019 (84 FR 17102). The NPRM was prompted by further analysis and WFD evaluations which identified the need to reduce the initial compliance times and repetitive intervals for the inspections for certain airplanes, and to add work for certain airplanes. The NPRM proposed to continue to require the actions of AD 2015-17-14. The NPRM also proposed to add actions for certain airplanes, and reduce the compliance times for certain airplanes. The FAA is issuing this AD to address cracking in the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, which could affect the structural integrity of the airplane. See the MCAI for additional background information.

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

Delta TechOps (DAL) asked that the applicability identified in paragraph (c) of the proposed AD be changed by adding the following language: “Serial number exceptions for Airbus production [modification] MOD status, as defined within the Applicability paragraph of EASA AD 2018-0233R1, are likewise acceptable for FAA AD applicability definition.” DAL stated that paragraph (c) applies to certain A320 family aircraft identified in the EASA AD, and noted that paragraph 2 of the EASA AD provides additional applicability details, namely, excluding serial numbers from the applicability based on the Airbus MOD status.

The FAA acknowledges the commenter's request and offers the following clarification: The intent of the applicability identified in paragraph (c) of this AD is to match the applicability in EASA AD 2018-0233R1, for airplanes with an FAA-approved type certificate, including exceptions based on modifications. Therefore, no change to this AD is necessary in this regard.

DAL asked that the method for obtaining corrective actions, as required by paragraph (g) of the proposed AD, be changed. DAL stated that those requirements entail complying with all required actions and compliance times specified in, and in accordance with, EASA AD 2018-0233R1. DAL added that, specifically, this means the method for obtaining all corrective actions is to contact Airbus. DAL asked that the method for obtaining corrective actions be changed as follows:

DAL noted that, as written, the proposed AD will limit authorization for corrective action solely to Airbus (EASA DOA), which restricts operator flexibility to obtain corrective action directly from the FAA or from the EASA.

The FAA disagrees with the commenter's request because the method proposed by the commenter is already provided in paragraph (i)(2) of this AD (as restated from the proposed AD), which in turn applies to paragraph (g) of this AD. Therefore, no change to this AD is necessary in this regard.

DAL asked that a deviation paragraph be added to the exceptions in paragraph (h) of the proposed AD as follows: “If accomplishing inspections according to a non-RC [required for compliance] revision of manufacturer Service Information, deviations from paragraphs other than paragraph 3.C. `Procedures' do not require an [alternative method of compliance] AMOC.” DAL stated that the inspection can be done using any revision of Airbus Service Bulletin A320-53-1257, and the original issue was not written in RC format. DAL added that operators have by now performed the initial inspection using the original issue of that service information. DAL noted that these inspections comply with the final rule because credit is allowed in EASA AD 2018-0233R1. DAL stated that it is possible that operators deviated from procedures outside of paragraph 3.C. when accomplishing a non-RC formatted service information revision, or may never have incorporated Revision 01 or Revision 02.

The FAA disagrees with the commenter's request. EASA AD 2018-0233R1 requires inspecting in accordance with Revision 02 of Airbus Service Bulletin A320-53-1257. If the inspection is done using the original issue or Revision 01 of the service information, credit is given for compliance in EASA AD 2018-0233R1. Any deviation from the service information must comply with the procedures found in 14 CFR 39.19. Therefore, no change to this AD is necessary in this regard.

DAL stated that the application of CML 12ADB1 Corrosion Preventative Compound should not be considered an RC step. DAL noted that operators are responsible for maintaining their own corrosion prevention programs, and application of corrosion inhibiting compounds (CICs) during embodiment of ADs should not be included with the RC steps.

The FAA does not agree to remove the requirement to apply CIC. The application of CIC is necessary to address the unsafe condition, and to ensure that the correct CIC is used, this AD requires use of the CIC referenced in the service information that is identified in the MCAI for the applicable product. However, under the provisions of paragraph (i)(1) of this AD, the FAA will consider requests for approval of another corrosion prevention compound if sufficient data are submitted to substantiate that it would provide an acceptable level of safety. The FAA has not changed this AD regarding this issue.

United Airlines (UAL) asked if the intent of paragraph (g) of the proposed AD is that operators are required to comply with EASA AD 2018-0233R1 in its entirety, except as noted in paragraph (h) of the proposed AD, or just compliance with the section in EASA AD 2018-0233R1 titled “Required Action(s) and Compliance Time(s).” UAL stated that the proposed AD should provide clarification so operators know the specific parts of the EASA AD necessary for compliance.

The FAA agrees to clarify the requirements in paragraph (g) of this AD. This AD requires compliance with EASA AD 2018-0233R1 in its entirety, through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in the EASA AD does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in the EASA AD. The FAA has not changed this AD in this regard.

JetBlue asked that the modification required by paragraph (8) of EASA AD 2018-0233R1 be added to the proposed AD as terminating action. The commenter also asked that credit be provided for actions done in accordance with FAA AD 2015-17-14 through related AMOCs.

The FAA acknowledges the commenter's request. However, the terminating action found in paragraph (8) of EASA AD 2018-0233R1 is already provided for in paragraph (g) of this AD, which requires complying with all required actions and compliance times specified in, and in accordance with, EASA AD 2018-0233R1. In addition, paragraph (i)(1)(ii) of this AD provides credit for AMOCs approved previously for AD 2015-17-14. Unless otherwise noted in this AD, all provisions of EASA AD 2018-0233R1 apply to the corresponding provisions of this AD. Therefore, the FAA has made no changes to this AD in this regard.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

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

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

EASA AD 2018-0233R1 describes procedures for repetitive inspections of the open tack holes and rivet holes of the fuselage frames below the cargo floor support fittings for cracking. This material 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, and it is publicly available through the EASA website.

The FAA estimates that this AD affects 1,009 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has received no definitive data that enables the agency to provide cost estimates for the on-condition actions specified in this AD.

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

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

(2) 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 amends 14 CFR part 39 as follows:

Discussion

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0053, dated March 14, 2019 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Saab AB, Saab Aeronautics Model SAAB 2000 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. The NPRM published in the Federal Register on July 3, 2019 (84 FR 31775). The NPRM was prompted by reports of cracks in the o-ring groove of magnetic fuel level indicators. The NPRM proposed to require a one-time detailed inspection of the magnetic fuel level indicator for cracks and replacement of cracked magnetic fuel level indicators.

The FAA is issuing this AD to address cracks in the o-ring groove of magnetic fuel level indicators, which, if not detected and corrected, could result in a severe fuel leak and consequent risk of fuel starvation. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA received no comments on the NPRM or on the determination of the cost to the public.

The FAA reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

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

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

Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems) has issued Service Bulletin 2000-28-027, dated January 15, 2019. This service information describes procedures for a one-time detailed inspection of the magnetic fuel level indicator for cracks and replacement of cracked magnetic fuel level indicators. 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 estimates that this AD affects 11 airplanes of U.S. registry. The agency estimates the following costs to comply with this AD:

Discussion

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model DHC-8-400 series airplanes. The NPRM published in the Federal Register on May 30, 2018 (83 FR 24694). The NPRM was prompted by reports of the NLG locking in a partially extended position due to loose bushings on the lock link of the NLG locking mechanism. The NPRM proposed to require inspecting the bushings and the lower lock link of the NLG for discrepancies, and corrective actions if necessary.

The FAA issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model DHC-8-400 series airplanes. The SNPRM published in the Federal Register on June 7, 2019 (84 FR 26601). The FAA issued the SNPRM to add a requirement to replace the lower lock link of the NLG, which would terminate the repetitive inspections proposed in the NPRM. The SNPRM also proposed to reduce the applicability in the NPRM.

The FAA is issuing this AD to address excessive free play at the lock link of the NLG locking mechanism, and consequent inability to fully retract or deploy the NLG, which could result in collapse of the NLG and affect the safe landing of the airplane.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2018-01R1, dated January 21, 2019 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain De Havilland Aircraft of Canada Limited (Type Certificate Previously Held by Bombardier, Inc.) Model DHC-8-400 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0453.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the SNPRM and the FAA's response to each comment.

Horizon Air asked that the requirement to do the actions specified in paragraph (k) of the proposed AD in accordance with paragraph 3.A. of the Accomplishment Instructions of Bombardier Service Bulletin 84-32-154, Revision A, dated November 21, 2018, be removed. Horizon Air stated that the job setup specified in paragraph 3.A. of the referenced service information does not directly correct the unsafe condition. Horizon Air would like only the actions specified in paragraph 3.B. of the referenced service information mandated.

The FAA does not agree with the commenter's request. For some ADs, the job setup actions in the associated service information do not affect the actions to correct the unsafe condition. However, for this AD, the FAA has determined that to adequately perform the corrective actions the job setup actions specified in Bombardier Service Bulletin 84-32-154, Revision A, dated November 21, 2018, must be accomplished. Paragraph 3.A., “Job Set-Up,” of Bombardier Service Bulletin 84-32-154, Revision A, dated November 21, 2018, includes specific procedures for the NLG to be in the correct configuration for the corrective actions to be done and prevent damage to the equipment. Therefore, the FAA has not changed this AD in this regard.

Horizon Air asked that installation of NLG drag strut assemblies having part number 47300-7A, 47300-9A, or 47300-11A, serviced in accordance with UTC Aerospace Systems Vendor Service Bulletin (VSB) 47300-32-138 R3, be allowed as terminating action for the repetitive inspections. Horizon Air stated that UTC Aerospace Systems VSB 47300-32-138 R3 can be done on units not installed on the airplane.

The FAA agrees to clarify. NLG drag strut assemblies can be serviced (lower lock links replaced and affected parts re-identified) by accomplishing UTC Aerospace Systems VSB 47300-32-138 R3, as specified in Bombardier Service Bulletin 84-32-154, Revision A, dated November 21, 2018. However, operators must still show compliance with paragraph 3.A. and Steps 3.B.(1), 3.B.(4) and 3.B.(5) of the Accomplishment Instructions of Bombardier Service Bulletin 84-32-154, Revision A, dated November 21, 2018, for the removal of a unit which has not been serviced, and installation of a serviced spare unit, in order to correct the unsafe condition. In addition, paragraph (f) of this AD specifies “Comply with this AD within the compliance times specified, unless already done.” Therefore, if some of the corrective actions have been done, only the remaining corrective actions must be completed to comply with this AD. The FAA has not changed this AD in this regard.

The FAA has revised this final rule to identify the legal name of the manufacturer as published in the most recent type certificate data sheet for the affected airplane models.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the SNPRM for addressing the unsafe condition; and

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

Bombardier has issued the following service information:

• Service Bulletin 84-32-153, Revision A, dated February 27, 2018, which describes procedures for general visual inspections of the bushings and the lower lock link of the NLG for discrepancies. The service information also describes procedures for repair or replacement of the lock link if any discrepancy is found.

• Service Bulletin 84-32-154, Revision A, dated November 21, 2018, which describes procedures for replacement of the existing lock link with a new lock link.

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 estimates that this AD affects 64 airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The FAA has received no definitive data that enables the agency to provide cost estimates for the on-condition actions specified in this AD.

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

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

(2) 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 amends 14 CFR part 39 as follows:

The FAA received reports of cracked inner tangs of the center wing lower rainbow fitting. Each tang (node) contains a single attachment bolt to the outer wing. If three or more tangs fail, the rainbow fitting can no longer carry limit load and the rainbow fitting may fail. This condition, if not addressed, could result in failure of the center wing lower rainbow fittings, wing separation, and loss of the airplane.

The FAA reviewed Lockheed Martin Aeronautics Company Alert Service Bulletin A382-57-98, Revision 1, dated August 16, 2019. This service information describes procedures for a visual inspection of the center wing upper and lower rainbow fittings for cracks, an eddy current inspection of the center wing lower rainbow fittings for cracks, and replacement if necessary. 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 is issuing 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 AD requires accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this AD and the Service Information.”

In light of the heavy reliance on aviation for intrastate transportation in Alaska, the FAA fully considered the effects of this AD (including costs to be borne by affected operators) from the earliest possible stages of AD development. This AD is based on those considerations, and was developed with regard to minimizing the economic impact on operators to the extent possible, consistent with the safety objectives of this AD. In any event, the Federal Aviation Regulations require operators to correct an unsafe condition identified on an airplane to ensure operation of that airplane in an airworthy condition. The FAA has determined in this case that the requirements are necessary and the indirect costs would be outweighed by the safety benefits of the AD.

Lockheed Martin Aeronautics Company Alert Service Bulletin A382-57-98, Revision 1, dated August 16, 2019, specifies that, for certain airplanes, Service Bulletin 382-57-97, or the results of a Lockheed Martin Operational Usage Evaluation (OUE) should be used to determine the number of flight hours on the center wing lower rainbow fittings. This AD would not allow the use of Service Bulletin 382-57-97 or the OUE to determine the number of flight hours on the center wing lower rainbow fittings, because Service Bulletin 382-57-97 and the OUE have not been approved by the FAA. If operators are unable to determine the number of flight hours on the center wing lower rainbow fittings, they must do the actions required by this AD within 30 days after the effective date of this AD.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C.) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking. Similarly, Section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because cracked inner tangs of the center wing lower rainbow fittings could result in failure of the center wing lower rainbow fittings, wing separation, and loss of the airplane. Furthermore, based upon the age of the fleet it is likely that many airplanes are beyond the threshold specified in this AD. Thus, the compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule.

Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the reasons stated above, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2019-0699 and Product Identifier 2019-NM-148-AD at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule 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 http://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this final rule.

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 AD 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 AD, 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 AD. Submissions containing CBI should be sent to Carl Gray, Aerospace Engineer, Airframe Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5554; fax: 404-474-5606; email: carl.w.gray@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 requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 30 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

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

Discussion

The Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil, has issued Brazilian AD 2019-02-02, dated February 28, 2019 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Embraer S.A. Model ERJ 170 airplanes; Model ERJ 190-100 STD, -100 LR, -100 ECJ, and -100 IGW airplanes; and Model ERJ 190-200 STD, -200 LR, and -200 IGW airplanes. You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-0325.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Embraer S.A. Model ERJ 170 airplanes; Model ERJ 190-100 STD, -100 LR, -100 ECJ, and -100 IGW airplanes; and Model ERJ 190-200 STD, -200 LR, and -200 IGW airplanes. The NPRM published in the Federal Register on May 29, 2019 (84 FR 24730). The NPRM was prompted by reports of the RAT compartment door seal peeling off and tangling up on the RAT rotor during flight test. The NPRM proposed to require a general visual inspection for peeling-off of the RAT compartment door seal, bonding if necessary, and the rework of the RAT compartment door seal attachment.

The FAA is issuing this AD to address the possible loss of the RAT function, which, when associated with an emergency electrical event, can result in the loss of airplane controllability. See the MCAI for additional background information.

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

JetBlue Airways and SkyWest Airlines Inc. requested an extension of the compliance time in paragraph (g)(1) of the proposed AD from 750 flight hours to 2,500 flight hours or 12 months. The commenters asserted that the new interval would align with the scheduled Maintenance Review Board tasks on the RAT, and that performing the AD at the same time as scheduled tasks would decrease the logistical burden of compliance.

The FAA disagrees with the commenters' request because the proposal contains no justification to show that an acceptable level of safety would be maintained. The FAA may, however, consider approving a longer compliance time as an alternative method of compliance (AMOC) with paragraph (g)(1) of this AD if sufficient substantiation is provided to show an acceptable level of safety. This AD has not been changed in this regard.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

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

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

Embraer S.A. has issued Service Bulletin SB170-53-0142, Revision 01, dated December 12, 2018; Service Bulletin SB190-53-0098, Revision 01, dated December 12, 2018; and Service Bulletin SB190LIN-53-0072, Revision 01, dated January 9, 2019. This service information describes procedures for an inspection of the RAT compartment door seal, bonding, and rework of the RAT compartment door seal attachment, which includes installing fasteners around the RAT door seal attachment. These documents are distinct since they apply to different airplane models. 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 estimates that this AD affects 570 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has received no definitive data that would enable the agency to provide cost estimates for the on-condition actions specified in this AD.

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

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.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

(2) 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 amends 14 CFR part 39 as follows:

The MPNMS is 18 square miles of waters and submerged lands encompassing and surrounding the Mallows Bay area of the tidal Potomac River. The area is located entirely within Maryland state waters, adjacent to the Nanjemoy Peninsula of Charles County, Maryland. The sanctuary protects nationally-significant maritime cultural heritage resources, including the fragile, historic remains of more than 100 World War I (WWI)-era U.S. Emergency Fleet Corporation (USEFC) wooden steamships known as the “Ghost Fleet,” vessels related to the historic ship-breaking operations, other non-USEFC vessels of historic significance, and related maritime debris fields. The area also includes Native American sites, remains of historic fisheries operations, and Revolutionary and Civil War battlescapes. The significance of the area is recognized through its listing on the National Register of Historic Places (National Register Listing Number 15000173, April 24, 2015). NOAA, the State of Maryland, and Charles County, Maryland, will jointly manage MPNMS.

Pursuant to Section 304(b) of the National Marine Sanctuaries Act (NMSA)(16 U.S.C. 1434(b)), NOAA published the designation and final regulations to implement the designation of MPNMS on July 8, 2019 (84 FR 32586). As required by the NMSA, the designation and regulations became effective following the close of a review period of 45 days of continuous session of Congress beginning on the date of publication, unless the Governor of the State of Maryland certifies to the Secretary of Commerce that the designation or any of its terms is unacceptable. The Governor did not certify that the designation or any of its terms is unacceptable within the review period prescribed under the NMSA. Accordingly, NOAA announces the designation and the final regulations to implement the designation of MPNMS became effective on September 3, 2019.

On June 28, 2018, the Commission published a final rule amending its FOIA regulations at 17 CFR 200.80 (Securities and Exchange Commission records and information). Because of the breadth of the amendments, the final rule removed the Commission's prior FOIA regulations in their entirety (§ 200.80 and appendices A through F) and replaced them with new regulations (§ 200.80).

In light of the 2018 amendments of its FOIA regulations, the Commission is now adopting technical amendments to other sections of title 17, chapter II of the Code of Federal Regulations to update cross-references to the Commission's FOIA regulations (§ 200.80) that are contained in those sections.

The Administrative Procedure Act (“APA”) generally requires an agency to publish notice of a rulemaking in the Federal Register and provide an opportunity for public comment. This requirement does not apply, however, if the agency “for good cause finds . . . that notice and public procedure are impracticable, unnecessary, or contrary to the public interest.”  1 The technical amendments do not impose any new substantive regulatory requirements on any person. The technical amendments merely update cross-references in the Commission's regulations. These amendments are therefore ministerial in nature. For these reasons, there is good cause for the Commission to find that it is unnecessary to publish notice of these amendments in the Federal Register or to solicit public comment thereon. 2 Although the APA generally requires publication of a rule at least 30 days before its effective date, for similar reasons we further find there is good cause for the amendments to take effect on September 26, 2019. Additionally, the provisions of the Regulatory Flexibility Act, which apply only when notice and comment are required by the APA or other law, are not applicable. 3 These amendments do not contain any collection of information requirements as defined by the Paperwork Reduction Act of 1995. 4

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

We are adopting technical amendments to update cross-references to Commission rules in light of recent amendments to the Commission's FOIA regulations. These amendments merely make conforming changes to Commission rules that cross-reference the FOIA regulations and do not impose any substantive regulatory obligations on any person or otherwise. We expect the amendments to help eliminate potential confusion that could result from outdated cross-references. We do not believe they will have any substantial economic effects, including on efficiency, competition, or capital formation. Further, because the amendments impose no new burdens on private parties, the Commission does not believe that the amendments will have any impact on competition for purposes of section 23(a)(2) of the Securities Exchange Act of 1934 (“Exchange Act”). 6

These technical amendments are adopted pursuant to statutory authority granted to the Commission under Section 19(a) of the Securities Act of 1933 and section 23(a) of the Exchange Act.

For the reasons set out above, the Commission is amending title 17, chapter II, of the Code of Federal Regulations as follows:

Table of Contents I. Background II. Summary and Explanation of the Final Rule III. Procedural Determinations I. Background

Appendix A of OSHA's Respiratory Protection Standard (29 CFR 1910.134) currently contains four quantitative fit testing protocols: Generated aerosol; ambient aerosol condensation nuclei counter (CNC); controlled negative pressure (CNP); and controlled negative pressure REDON. TSI Incorporated (“TSI”) proposed the ambient aerosol CNC protocol—often called the PortaCount® protocol after the CNC instrument manufactured by TSI—in 1987. OSHA allowed the ambient aerosol CNC protocol for fit testing under a compliance interpretation published in 1988. OSHA eventually incorporated that protocol into appendix A of the Respiratory Protection Standard when it revised the standard in 1998.

In 2006, TSI submitted two additional quantitative fit testing protocols to OSHA for approval and inclusion in appendix A of the Respiratory Protection Standard. These protocols were modified, abbreviated versions of the original ambient aerosol CNC protocol already approved by OSHA and listed in appendix A. OSHA published a notice of proposed rulemaking (NPRM) on January 21, 2009 (74 FR 3526) to include the two protocols in its Respiratory Protection Standard, but later concluded that they were not sufficiently accurate or reliable. OSHA withdrew the proposed rule without prejudice on January 27, 2010 (75 FR 4323), and invited the developers to resubmit the two protocols after addressing the issues of concern listed in the withdrawal notification. In 2014, TSI submitted three new quantitative fit testing protocols for OSHA approval. These three protocols also were modified, abbreviated versions of the original ambient aerosol CNC protocol, but different from the two protocols TSI submitted to OSHA in 2006.

Part II of appendix A of OSHA's Respiratory Protection Standard specifies the procedure for adding new fit testing protocols to the standard. Under that procedure, if OSHA receives an application for a new fit testing protocol meeting certain criteria, it must commence a rulemaking proceeding to consider adopting the proposed protocol. These criteria are: (1) A test report prepared by an independent government research laboratory ( e.g., Lawrence Livermore National Laboratory, Los Alamos National Laboratory, the National Institute for Standards and Technology) stating that the laboratory tested the protocol and found it to be accurate and reliable; or (2) an article published in a peer-reviewed industrial hygiene journal describing the protocol and explaining how the test data support the protocol's accuracy and reliability. TSI's 2014 application for approval of three new quantitative fit testing protocols met the second criterion. OSHA considers such proposals under the notice-and-comment rulemaking procedures specified in Section 6(b)(7) of the Occupational Safety and Health Act of 1970 (the “Act”) (29 U.S.C. 655(b)(7)).

In July 2014, TSI submitted an application requesting that OSHA approve three new quantitative fit testing protocols for inclusion in appendix A of OSHA's Respiratory Protection Standard (OSHA-2015-0015-0003). These three protocols were modified, abbreviated versions of the original ambient aerosol CNC protocol approved by OSHA and listed in appendix A, but different from the ones submitted to OSHA by TSI in 2006. TSI's application included three peer-reviewed articles (“the Richardson studies”) describing the accuracy and reliability of TSI's proposed protocols. 1 The application letter also included a copy of the 2010 ANSI/AIHA (American National Standards Institute/American Industrial Hygiene Association) Z88.10 “Respirator Fit Testing Methods” standard (“the ANSI standard”), which contains “Annex A2: Criteria for Evaluating New Fit Test Methods” (“the ANSI annex”) (OSHA-2015-0015-0007). TSI also submitted two white papers: One describing TSI's analysis of its talking exercise data and the second describing TSI's process and rationale behind the fit test exercises that were employed in the Richardson studies (OSHA-2015-0015-0001, OSHA-2015-0015-0008). OSHA determined that the information submitted in TSI's application met the criteria required for initiating a rulemaking to determine whether OSHA should approve the new protocols and add them to appendix A of the Respiratory Protection Standard. OSHA issued a notice of proposed rulemaking (NPRM) on October 7, 2016, proposing to add the new protocols and inviting public comments.

The three new protocols submitted by TSI in July 2014 included one for full-facepiece elastomeric respirators (the Fast-Full method), one for half-mask elastomeric respirators (the Fast-Half method), and one for filtering facepiece respirators (FFRs) (the Fast-FFR method). The authors of the Richardson studies evaluated each of the three types of respirators for method performance separately, but the protocols for the Fast-Full and Fast-Half methods were identical. As such, and to prevent duplicative regulatory text, OSHA proposed to consolidate the Fast-Full and Fast-Half methods into a single protocol for approval: The modified ambient aerosol condensation nuclei counter (CNC) quantitative fit testing protocol for full-facepiece and half-mask elastomeric respirators. OSHA further proposed to approve the Fast-FFR protocol as the modified ambient aerosol condensation nuclei counter (CNC) quantitative fit testing protocol for filtering facepiece respirators. No commenters objected to the consolidation and naming of the protocols during the public comment period.

The original ambient aerosol CNC protocol consists of eight test exercises, performed in the following order: Normal breathing, deep breathing, turning head side-to-side, moving head up-and-down, talking, grimace, bending over, and normal breathing again. The modified ambient aerosol CNC protocol for full-facepiece and half-mask elastomeric respirators differs as follows: (1) It includes only three of the eight original test exercises (bending over, head side-to-side, and head up-and-down); (2) it adds jogging-in-place as a new exercise; and (3) it reduces the total test duration from 7.2 to 2.5 minutes. The modified ambient aerosol CNC protocol for FFRs differs from the original ambient aerosol CNC protocol as follows: (1) It includes only four of the eight original test exercises (bending over, talking, head side-to-side, and head up-and-down) and (2) it reduces the total test duration from 7.2 to 2.5 minutes.

The three Richardson studies (OSHA-2015-0015-0004, OSHA-2015-0015-0005, OSHA-2015-0015-0006) compared the fit factors for the new protocols to a reference method based on the approach specified in the ANSI annex. 2 This approach requires the performance evaluation study to administer sequential paired tests using the proposed fit testing method and reference method during the same respirator donning. The reference method consisted of the standard OSHA exercises listed in Section I.A.14 of appendix A of the Respiratory Protection Standard (which are also the eight test exercises used for the original ambient aerosol CNC protocol), minus the grimace exercise, in the same order as described in the standard ( i.e., normal breathing, deep breathing, head side-to-side, head up-and-down, talking, bending over, normal breathing). Each exercise was performed for 60 seconds.

These protocols will serve as alternatives to the four existing quantitative fit testing protocols already listed in appendix A of the Respiratory Protection Standard and will maintain safety and health protections for workers while providing additional flexibility and reducing compliance burdens. This rule is a deregulatory action under Executive Order 13771 (82 FR 9339 (January 30, 2017)). It has annualized net cost savings estimated at $4.1 million. A detailed discussion of OSHA's estimates of the rule's benefits, costs, and cost savings is included in the Final Economic Analysis and Regulatory Flexibility Certification section.

TSI supported its application for adding the new protocols with the three Richardson studies that indicate respectively that the proposed Fast-Half, Fast-Full, and Fast-FFR methods can identify poorly fitting respirators as well as the reference method used. Each article described a study that compared fit test results using a reference method specified in the ANSI annex with results using one of the proposed methods. The following subsections detail the methodologies and findings of the three Richardson studies.

The first Richardson study evaluated the Fast-Half method. 3 The study authors selected three models of NIOSH-approved, half-mask air-purifying respirators—each available in three sizes—from “leading U.S. mask manufacturers” equipped with P100 filters. 4 Respirators were probed with a flush sampling probe located between the nose and mouth. The study included 9 female and 16 male participants.

Each test subject donned a respirator for a five-minute comfort assessment and then performed two sets of fit test exercises, one using the reference method and another the Fast-Half method. The study authors randomized the order of the two sets of fit test exercises for each test subject. The reference method consisted of the eight standard OSHA exercises listed in Section I.A.14 of appendix A of the Respiratory Protection Standard, minus the grimace exercise, in the same order as required in the standard ( i.e., normal breathing, deep breathing, head side-to-side, head up-and-down, talking, bending over, normal breathing). The study subject performed each exercise for 60 seconds.

The study authors explained that they decided to exclude the grimace exercise because it “is intended to break the respirator seal to the face” which “potentially results in a shift of the respirator” (OSHA-2015-0015-0004). TSI submitted an additional explanation as to why the grimace exercise was excluded in all three Richardson studies (OSHA-2015-0015-0008). According to TSI, “[l]ittle or no support was found for the grimace exercise among respirator fit test experts,” and “[t]he most common fault expressed by a number of experienced fit testers and industry experts was that the grimace cannot be consistently applied or even defined” ( Id. ). TSI further explained that the grimace exercise is intended to break the face seal, which may not reseal in the same way for subsequent exercises. As a result, the shift in the respirator caused by grimacing can potentially confound comparisons between the fit test methods. TSI finally noted that the fit factor from the grimace exercise (if measured) is not used to calculate the overall fit factor result under the original ambient aerosol CNC method.

The Fast-Half method included four exercises: Bending, jogging-in-place, head side-to-side, and head up-and-down. Each test subject took two breaths at each extreme of the head side-to-side and head up-and-down exercises and at the bottom of the bend in the bending exercise.

Although not discussed in the Richardson study, TSI explained its rationale for selecting the exercises that were later utilized in the three Richardson studies. The exercises were identified, by TSI, as being the most rigorous for ( i.e., the best at) identifying poor fitting respirators in two white papers TSI prepared and submitted to OSHA (OSHA-2015-0015-0001, OSHA-2015-0015-0008). TSI reached its conclusions and selected the exercises based on a literature review, informal conversations with industry fit test experts, and in-house pilot studies. “Talking out loud,” “bending,” and “moving head up/down” were determined to be the three most critical exercises in determining the overall fit factor for abbreviated respirator fit test methods by Zhuang et al. (OSHA-2015-0015-0011). 5 TSI's in-house pilot fit testing studies supported the conclusions made by Zhuang et al., however, additional analysis of the TSI data by TSI uncovered an unexpected trend within the data for the talking exercise (OSHA-2015-0015-0001, OSHA-2015-0015-0008). TSI collected fit test data on subjects using consecutive sets of the seven-exercise reference method described above. TSI analyzed the frequency with which each exercise produced the lowest fit factor. Fit test data were separated into three groups: All fit tests, good-fitting fit tests, and poor-fitting fit tests. A poor-fitting fit test was defined as any test where at least one exercise failed, and a good-fitting fit test was defined as one where no exercises failed. 6 TSI's results showed that normal breathing, deep breathing, and talking rarely produced the lowest fit factor (frequency ≤3 percent) for poor-fitting full-facepiece respirators. On this basis, these three less rigorous exercises were eliminated by TSI for both the Fast-Full and Fast-Half methods. The bending exercise was the most rigorous exercise for poor-fitting full-facepiece and half-mask elastomeric respirators. Talking was the exercise among the seven exercises that most often had the lowest fit factor for good-fitting full-facepiece and half-mask respirators in the TSI pilot study. None of the other exercises stood out for half-mask respirators, but TSI reasoned that there was a lack of data suggesting that half-mask respirator fit tests should use different exercises than full-facepiece respirators (OSHA-2015-0015-0008). TSI added jogging-in-place for a fourth rigorous test exercise as part of the protocol that the Richardson authors would evaluate, reasoning that jogging “leverages the weight of the facepiece, much like bending, but on a different axis, and also because both OSHA and ANSI currently include jogging as an alternative exercise” (OSHA-2015-0015-0008). Jogging-in-place is an alternate ( i.e., elective as opposed to required) exercise in the ANSI annex. The study authors stated that jogging is “aggressive in terms of evaluating the respirator seal” (OSHA-2015-0015-0004).

The study authors conducted the experiments in a large chamber and added sodium chloride (NaCl) aerosol to augment particle concentrations, which they expected to range between 5,000 and 20,000 particles/cm 3 (target = 10,000 p/cm 3 ). The study authors used a single CPC instrument, the PortaCount® Model 8030 (TSI Incorporated, Shoreview MN), for sampling and valuation. They connected the instrument to two equal-length sampling tubes. The first tube sampled particle concentrations inside the facepiece, and the second tube sampled the ambient particle concentration. The authors used TSI software to switch between sampling lines and to record concentration data.

During the reference method, for each exercise, the ambient sampling tube was first purged for four seconds before an ambient sample was taken for 5 seconds, followed by an 11-second purge of the in-facepiece sampling tube and a 40-second in-facepiece sample. The reference method took a total of 429 seconds (7 minutes 9 seconds) to complete.

For the reference method, the authors calculated a fit factor for each exercise by dividing the mean ambient concentration for that exercise by the in-facepiece concentration taken during each exercise (average of the five-second ambient measurements before and after the exercise). The harmonic mean of the seven exercise fit factors equaled the overall fit factor. During the first exercise of the Fast-Half method (bending over), the ambient sampling tube was first purged for 4 seconds before an ambient sample was taken for five seconds; the in-facepiece sampling tube was then purged for 11 seconds and a sample was then taken from inside the mask for 30 seconds. No ambient sample was taken during the next two exercises (jogging and head side-to-side)—just one 30-second in-facepiece sample was collected for each exercise. For the last exercise (head up-and-down), a 30-second in-facepiece sample was taken, after which a 4-second ambient purge and 5-second ambient sample were conducted. The Fast-Half method took a total of 149 seconds (2 minutes 29 seconds) to complete.

For the Fast-Half method, the ambient concentration was calculated by taking the mean of two measurements—one before the first exercise and one after the last exercise. The authors calculated fit factors for each exercise by dividing the in-facepiece concentration taken during that exercise by the mean ambient concentration. As with the reference method, the harmonic mean of the four exercise fit factors represented the overall fit factor. A minimum fit factor of 100 is required in order to be regarded as an acceptable fit for half-mask respirators under appendix A of the Respiratory Protection Standard.

To ensure that respirator fit was not significantly altered between the two sets of exercises, a 5-second normal breathing fit factor assessment was included before the first exercise set, between the two sets of exercises and at the completion of the second exercise set. If the ratio of the maximum to minimum of these three fit factors was greater than 100, this experimental trial was excluded from data analysis.

The ANSI annex specifies that an exclusion zone within one coefficient of variation for the reference method must be determined. The exclusion zone is the range of measured fit factors around the pass/fail fit factor of 100 that cannot be confirmed to be greater than 100 or less than 100 with adequate confidence and, therefore, should not be included in evaluating performance. The study authors determined the variability associated with the reference method using 48 pairs of fit factors from 16 participants. They defined the exclusion zone as fit factor measurements within one standard deviation of the 100 pass/fail value. Six pairs of fit factors were omitted by the study authors because the normal breathing fit factor ratio exceeded 100 and 5 pairs of fit factors were omitted because they were identified as outliers (> 3 standard deviations from the mean of the remaining data points). The exclusion zone calculated by the study authors ranged from 82 to 123 and did not include the five outliers. During review of the study methods, OSHA felt that omitting outliers to define a variability-based exclusion zone deviated from the usual scientific practice. Therefore, OSHA recalculated the exclusion zone with the outlier data included in the analysis (OSHA-2015-0015-0009). The recalculated exclusion zone was somewhat wider, ranging from 68 to 146.

The final dataset for the ANSI Fast-Half performance evaluation included 134 pairs of fit factors from 25 participants. The respirator models and sizes were used in nearly equal proportion. The study authors omitted eleven pairs of fit factors because the ratio of maximum to minimum normal breathing fit factors was greater than 100. They also omitted one pair due to a methodological error (sample line detached from respirator during test). As such, 122 pairs were included in the data analysis.

The study authors concluded that their statistical analysis indicates that the Fast-Half method met the required acceptance criteria for test sensitivity, predictive value of a pass, predictive value of a fail, test specificity, and kappa statistic  7 as defined in the ANSI annex (see Table 1). The same was indicated by OSHA's statistical analysis, utilizing the wider OSHA-recalculated exclusion zone, which excluded an additional three pairs for a total of nine pairs excluded and 119 pairs included in the analysis. OSHA therefore agrees with the study authors that the Fast-Half method can identify poorly fitting respirators at least as well as the reference method.

The second Richardson study evaluated the Fast-Half method. 8 The study authors selected three models of NIOSH-approved, full-facepiece air-purifying respirators from “leading U.S. mask manufacturers” equipped with P100 filters. Each model was available in three sizes. Respirators were probed with a non-flush sampling probe inside the nose cup, extending 0.6 cm into the breathing zone. The study included 11 female and 16 male participants. The reference method, choice of exercises, PortaCount® instrument, test aerosol, and sampling sequence were identical to those used for the Fast-Half method. Appendix A of the Respiratory Protection Standard requires a minimum fit factor of 500 for full-facepiece respirators.

The study authors determined the variability associated with the reference method using 54 pairs of fit factors from 17 participants. The exclusion zone was defined as fit factor measurements within one standard deviation of the 500 pass/fail value. Five pairs of fit factors were omitted because the normal breathing fit factor ratio exceeded 100, and three pairs of fit factors were omitted because they were identified as outliers (> 3 standard deviations from the mean of the remaining data points). The exclusion zone calculated by the study authors ranged from 345 to 726 and did not include the three outliers. OSHA recalculated the exclusion zone with the outlier data included in the analysis (OSHA-2015-0015-0009). The recalculated exclusion zone determined by OSHA was somewhat wider ranging from 321 to 780.

The final dataset for the ANSI Fast-Full performance evaluation included 148 pairs of fit factors from 27 participants. The respirator models and sizes were used in nearly equal proportion. Eleven pairs were omitted because the ratio of maximum to minimum normal breathing fit factors was greater than 100; one pair was omitted due to an observational anomaly (a torn piece of a cleaning wipe was observed in the respirator during the test); 136 pairs were included in the data analysis.

The study authors concluded that their statistical analysis indicates that the Fast-Full method met the required acceptance criteria for test sensitivity, predictive value of a pass, predictive value of a fail, test specificity, and kappa statistic as defined in the ANSI annex (see Table 1). The same was indicated by OSHA's statistical analysis, utilizing the wider OSHA-recalculated exclusion zone, which excluded an additional three pairs for a total of 15 pairs excluded and 133 pairs included in the analysis. OSHA therefore agrees with the study authors that the Fast-Full method can identify poorly fitting respirators at least as well as the reference method.

The third Richardson article evaluated the Fast-FFR method. 9 Ten models of NIOSH-approved N95 FFRs from six “leading U.S. mask manufacturers” were selected for study. 10 The different models were selected to represent a range of styles: six cup-shaped, two horizontal flat-fold, and two vertical flat-fold models. No information was provided in the publication about whether models were available in different sizes. However, at OSHA's request, TSI submitted the following additional information regarding the choice of respirators (OSHA-2015-0015-0010):

Respirators were probed with a flush sampling probe located between the nose and mouth. Lightweight sample tubing and neck straps were used to ensure the tubing did not interfere with respirator fit. Twenty-nine participants (11 female; 18 male) were included in the study. The reference method, test aerosol, and most other study procedures were analogous to those used for the Fast-Half and Fast-Full methods. However, the Fast-FFR method employed these four exercises: Bending, talking, head side-to-side, and head up-and-down with the same sampling sequence and durations as the other test protocols. The talking exercise replaces the jogging exercise used in the Fast-Half and Fast-Full methods. TSI decided not to eliminate the talking exercise for FFRs even though their pilot study indicated that it rarely produces the lowest fit factor (OSHA-2015-0015-0008). They felt from their own experience that jogging does not represent the kind of motions that FFR wearers do when using the respirator (OSHA-2015-0015-0008). TSI also indicated that the sampling probe configured on lightweight FFR respirators caused the respirator to pull down and away from the face during jogging creating unintentional leakage. A PortaCount® Model 8038 operated in the N95 mode (TSI Inc., Shoreview MN) was used to measure aerosol concentrations throughout the experiments. The particle concentrations in the test chamber were expected to be greater than 400 p/cm 3 . A minimum fit factor of 100 is required in order to be regarded as an acceptable fit for these types of respirators under appendix A of the Respiratory Protection Standard.

The study administered sequential paired fit tests using the Fast-FFR method and a reference method according to the ANSI annex. The study authors randomized the order of the two sets of fit test exercises for each test subject. The study authors determined the variability associated with the reference method using 63 pairs of fit factors from 14 participants. They defined the exclusion zone as fit factor measurements within one standard deviation of the 100 pass/fail value. Two pairs of fit factors were omitted by the study authors because the normal breathing fit factor ratio exceeded 100, and six pairs of fit factors were omitted because they were identified as outliers (>3 standard deviations from the mean of the remaining data points). The exclusion zone calculated by the study authors ranged from 78 to 128 and did not include the six outliers. OSHA recalculated the exclusion zone with the outlier data included in the analysis (OSHA-2015-0015-0009). The recalculated exclusion zone was somewhat wider, ranging from 69 to 144.

The final dataset for the ANSI Fast-FFR performance evaluation included 114 pairs of fit factors from 29 participants. The respirator models were used in nearly equal proportion. The authors omitted two pairs because the ratio of maximum to minimum normal breathing fit factors was greater than 100, leaving 112 pairs for the data analysis.

The study authors concluded that their statistical analysis indicates that the Fast-FFR method met the required acceptance criteria for test sensitivity, predictive value of a pass, predictive value of a fail, test specificity, and kappa statistic as defined in the ANSI annex (see Table 1). The same was found by OSHA's statistical analysis, utilizing the wider OSHA-recalculated exclusion zone, which excluded an additional four pairs for a total of 11 pairs excluded and a 102 pairs included in the analysis. OSHA therefore agrees with the study that the Fast-FFR method can identify poorly fitting respirators at least as well as the reference method.

While appendix A of OSHA's Respiratory Protection Standard specifies the procedure for adding new fit testing protocols to the standard, it does not specify any particular method(s) or criteria for evaluating a new fit test. Section 6(a) of the Act directs the Secretary of Labor to promulgate by rule “as an occupational safety or health standard any national consensus standard . . . unless he determines that the promulgation of such a standard would not result in improved safety or health for specifically designated employees.” 29 U.S.C. 655(a). Section 6(b)(8) of the Act further states: “Whenever a rule promulgated by the Secretary differs substantially from an existing national consensus standard, the Secretary shall, at the same time, publish in the Federal Register a statement of the reasons why the rule as adopted will better effectuate the purposes of this Act than the national consensus standard.” 29 U.S.C. 655(b)(8). And OSHA has a long history of considering national safety and health consensus standards, such as ANSI and NFPA (National Fire Protection Association), in developing its own standards.

The National Technology Transfer and Advancement Act of 1995 similarly endorses agencies' use of national consensus standards: “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” Public Law 104-113, section 12(d), 110 Stat. 775, 783 (1996), 15 U.S.C. 272 note. ANSI/AIHA is such a voluntary consensus standards body, whose standards, including Z88.10, are widely recognized and accepted by the industrial hygiene community. OSHA concurs with ANSI that “this annex [A2] provides a specific procedure for evaluating fit test methods against the current body of knowledge.” OSHA therefore considers the annex's procedure to be a valid, acceptable method for evaluating new fit test protocols (ANSI/AIHA, 2010).

In the October 2016 NPRM, OSHA preliminarily determined that the new protocols met the sensitivity, specificity, predictive value, and other criteria outlined in the ANSI annex and would, therefore, provide employees with at least as much protection as the reference method. That reference method consisted of the standard OSHA exercises listed in Section I.A.14 of appendix A of the Respiratory Protection Standard (which are the eight test exercises used for the original ambient aerosol CNC protocol), minus the grimace exercise, in the same order as described in the standard ( i.e., normal breathing, deep breathing, head side-to-side, head up-and-down, talking, bending over, normal breathing). OSHA further concluded that it was reasonable to remove the grimace exercise from the reference method during the method comparison testing, because its inclusion would unpredictably impact respirator fit (see Question #10 below for a more detailed discussion). After having considered the comments submitted in response to the NPRM (discussed below), OSHA has concluded that it is appropriate to amend appendix A of the Respiratory Protection standard to include the proposed fit test protocols.

In the NPRM, OSHA invited public comment on the accuracy and reliability of the proposed protocols, their effectiveness in detecting respirator leakage, and their usefulness in selecting respirators that will protect employees from airborne contaminants in the workplace. OSHA invited public comment on the following specific questions:

1. Were the three studies described in the peer-reviewed journal articles well controlled and conducted according to accepted experimental design practices and principles?

2. Were the results of the three studies described in the peer-reviewed journal articles properly, fully, and fairly presented and interpreted?

3. Did the three studies treat outliers appropriately in determination of the exclusion zone?

4. Will the two proposed protocols generate reproducible fit testing results?

5. Will the two proposed protocols reliably identify respirators with unacceptable fit as effectively as the quantitative fit testing protocols, including the OSHA-approved standard PortaCount® protocol, already listed in appendix A of the Respiratory Protection Standard?

6. Did the protocols in the three studies meet the sensitivity, specificity, predictive value, and other criteria contained in the ANSI/AIHA Z88.10-2010, Annex A2, Criteria for Evaluating Fit Test Methods?

7. Are the specific respirators selected in the three studies described in the peer-reviewed journal articles representative of the respirators used in the United States?

8. Does the elimination of certain fit test exercises ( e.g., normal breathing, deep breathing, talking) required by the existing OSHA-approved standard PortaCount® protocol impact the acceptability of the proposed protocols?

9. Is the test exercise, jogging-in-place, that has been added to the Fast-Full and Fast-Half protocols appropriately selected and adequately explained? Should the jogging exercise also be employed for the Fast-FFR protocol? Is the reasoning for not replacing the talking exercise with the more rigorous jogging exercise in the Fast-FFR protocol (as was done in Fast-Full and Fast-Half) adequately explained?

10. Was it acceptable to omit the grimace from the reference method employed in the studies evaluating performance of the proposed fit testing protocols? Is it appropriate to exclude the grimace completely from the proposed protocols, given that it is not used in the calculation of the fit factor result specified under the existing or proposed test methods? If not, what other criteria could be used to assess its inclusion or exclusion?

11. The protocols in the three studies specify that participants take two deep breaths at the extreme of the head side-to-side and head up-and-down exercises and at the bottom of the bend in the bend-forward exercise. According to the developers of these protocols, the deep breaths are included to make the exercises more rigorous and reproducible from one subject to the next. Are these additional breathing instructions adequately explained in the studies and in the proposed amendment to the standard? Are they reasonable and appropriate?

12. Does OSHA's proposed regulatory text for the two new protocols offer clear instructions for implementing the protocols accurately?

OSHA received 27 comments from 25 separate individuals, with one individual submitting three separate comments (OSHA-2015-0015-0015 to OSHA-2015-0015-0042). In addition, TSI submitted a comment several months after the close of the comment period (OSHA-2015-0015-0047). OSHA added TSI's comment to the docket as a late submission in the interest of full disclosure but did not take it into account.

Of the 27 timely comments, six did not specifically address any of OSHA's specific questions, but were generally in favor of the proposed protocols (OSHA-2015-0015-0016, OSHA-2015-0015-0018, OSHA-2015-0015-0019, OSHA-2015-0015-0020, OSHA-2015-0015-0030, OSHA-2015-0015-0039). Among other things, these comments agreed that the abbreviated protocols would save time and resources and would increase employer compliance with safety and health regulations.

OSHA addresses below the comments that addressed the NPRM's specific questions:

1. Were the three studies described in the peer-reviewed journal articles well controlled and conducted according to accepted experimental design practices and principles?

The majority of concerned comments about the proposed protocols related to the experimental design and methods used in the three Richardson studies supporting the proposed protocols. The most common of these criticisms was that the testing was not representative of “real world” settings (OSHA-2015-0015-0022, OSHA-2015-0015-0025, OSHA-2015-0015-0026, OSHA-2015-0015-0027, OSHA-2015-0015-0032, OSHA-2015-0015-0033, OSHA-2015-0015-0040, OSHA-2015-0015-0041, OSHA-2015-0015-0042). For example, one commenter asserted that the environment of the test chambers used in the three Richardson studies was “too controlled” and that the studies “did not allow for variables encountered by fit test providers when conducting fit testing in real world settings” (OSHA-2015-0015-0026). Another commenter stated: “In an uncontrolled environment many factors, including but not limited to, ventilation, doors being opened, and room temperature can greatly affect the particle count in a relatively short time” (OSHA-2015-0015-0040).

Regarding these comments, OSHA would like to stress that the proposed protocols were evaluated using the criteria outlined in Annex A2 of the ANSI/AIHA Z88.10-2010 standard, which does not require uncontrolled testing conditions with variables such as fluctuating climate, temperature, elevation, air currents, ventilation, etc. OSHA considers the ANSI annex method to be a valid method for evaluating new fit test protocols.

Many of these comments related specifically to the use of generated aerosols in the three Richardson studies (OSHA-2015-0015-0022, OSHA-2015-0015-0026, OSHA-2015-0015-0033, OSHA-2015-0015-0041). For example, one commenter stated:

None of the three Richardson studies, however, employed a “generated aerosol” atmosphere as described in the ANSI/AIHA Z88.10 standard; instead, they used “the ambient laboratory aerosol which was augmented by NaCl particles from a TSI Model 8026 Particle Generator” (OSHA-2015-0015-0004, OSHA-2015-0015-0005, OSHA-2015-0015-0006). This approach is allowed by ANSI/AIHA in Annex A2, which states that “a proposed modification to an accepted QNFT [quantitative fit testing] protocol can be evaluated using the accepted protocol for that instrument as the reference standard.” As some commenters noted (OSHA-2015-0015-0031, OSHA-2015-0015-0041), it is often necessary to augment the ambient environment when using the original OSHA-approved ambient aerosol CNC fit test method in a relatively clean office environment. The TSI particle generator is one of several approaches commonly used (OSHA-2015-0015-0051, OSHA-2015-0015-0050). In fact, as noted by one commenter, technicians sometimes burn candles or incense in order to reach and maintain ambient particle counts (OSHA-2015-0015-0032). OSHA has concluded that there is no material difference between the experimental atmosphere employed in the three Richardson studies and the atmosphere commonly used for quantitative fit testing with the ambient aerosol CNC method.

Other commenters expressed concerns that the ambient and purge times were too short (OSHA-2015-0015-0022, OSHA-2015-0015-0026, OSHA-2015-0015-0027, OSHA-2015-0015-0032, OSHA-2015-0015-0033, OSHA-2015-0015-0036, OSHA-2015-0015-0038, OSHA-2015-0015-0041, OSHA-2015-0015-0042). For example, one commenter recommended that the proposed protocols “should provide for suitable ambient and respirator purge durations to address the full range of particle concentrations that the device is recommended for use in instead of selecting a duration based on the optimum conditions that were selected for the studies. . . .” (OSHA-2015-0015-0026). Several commenters were also concerned that each ambient sample conducted at the beginning and end of the new protocols lasted only five seconds (OSHA-2015-0015-0032, OSHA-2015-0015-0036, OSHA-2015-0015-0042).

Regarding these comments, OSHA notes that for every exercise (except the grimace), the original OSHA-approved ambient aerosol CNC protocol involves a 4-second ambient purge, a 5-second ambient sample, and an 11-second mask purge, followed by a 40-second mask sample. A final 4-second ambient purge and 5-second ambient sample occur after the last 40-second exercise (normal breathing) mask sample. The proposed protocols employ the same 4-second ambient purge, 5-second ambient sample, and 11-second mask purge, followed by 4 consecutive 30-second mask samples during each of the 4 exercises, and a final 4-second ambient purge and 5-second ambient sample. The ambient purge and sample times are the same. The new protocols differ from the original OSHA-approved sampling protocol in these ways: The ambient environment is measured only at the beginning and end of the exercises and not between each exercise, mask purging occurs just once (after the first ambient sample), and mask sampling time is 30 seconds rather than 40 seconds. Additionally, requirements for conducting the fit test in an environment with an adequate particle concentration also did not change; they have been standard practice for the ambient aerosol CNC fit test method since its inception and approval by OSHA.

Regarding ambient measurements, the only difference between the new protocols and the original OSHA-approved protocol is that the new protocols take measurements at the beginning and end of the exercises, while the original protocol does so between each exercise. Because the total duration of the new protocols is much shorter than the original—2.5 minutes versus 7.2 minutes—OSHA has concluded that there is no need to take periodic samples between exercises. In particular, the time between the two ambient samples in the proposed protocol is 2 minutes 15 seconds, compared to 55 seconds between each ambient sample in the original protocol. This minor difference is unlikely to introduce any significant errors if fit testers follow standard practice: (1) Ensure the aerosol concentration falls between 1,000 and 30,000 particles/cm 3 (p/cm 3 ) for filters with a NIOSH designation of N/R/P-99 or 100, and 30 to 1,500 p/cm 3 for filters with a N/R/P-95 designation; and (2) do not augment the ambient environment if the concentration exceeds 8000 p/cm 3 or 800 p/cm 3 for the 99/100 or the 95 filters, respectively (OSHA-2015-0015-0049).

Two commenters expressed concern over eliminating purging between exercises altogether (OSHA-2015-0015-0022, OSHA-2015-0015-0038). But there is no reason for purging between the different exercises in the proposed protocol because the instrument continues to sample from the same environment (inside the facepiece) throughout the exercises. Particles measured during the first few seconds of transition from one exercise to the next will have almost no influence on the average concentration over a 30-second exercise sampling period.

Purging ensures that the sensing volume evaluates particles from the correct environment and is only necessary when switching between ambient and mask samples or vice versa. The proposed protocols do not switch between ambient and mask sampling during the exercises, so purging is not required.

Some commenters requested further review of the methodology of the three Richardson studies or further validation testing by a “third party” (OSHA-2015-0015-0029, OSHA-2015-0015-0040). OSHA notes that the studies were conducted by a third party, Battelle Memorial Institute, and the study methods were approved by Battelle's Institutional Review Board. In addition, NIOSH stated that their “review determined that the three methods met the criteria contained in the ANSI/AIHA Z88.10-2010, Annex A2” (OSHA-2015-0015-0031). And one commenter who had some concerns about the proposed protocols conceded that the “referenced peer-reviewed articles in J. of Respiratory Protection appear to meet the mathematical and statistical criteria we expect” (OSHA-2015-0015-0024). Finally, the publication of the three Richardson studies in a peer-reviewed industrial hygiene journal suggests they were well-controlled and conducted according to accepted experimental design practices and principles. In summary, OSHA determined that the public comments did not identify any significant shortcomings in the experimental design and methodology used in the three studies.

2. Were the results of the three studies described in the peer-reviewed journal articles properly, fully, and fairly presented and interpreted?

Although critical of the fact that the studies were conducted in a test chamber as opposed to a real world setting, one commenter stated “that under the specific set of conditions that the tests were performed that they were presented well” (OSHA-2015-0015-0026). But another commenter expressed that it was “impossible to determine if the articles were properly, fully, and fairly presented and interpreted” because the articles did not provide data tables listing “respirator make, model, style, size, individuals tested, and the paired results of the new test and the reference test” as outlined in the ANSI annex (OSHA-2015-0015-0038). The annex recommends—but does not require—such tables, and it is often difficult to publish a peer-reviewed article containing a complete dataset. Regardless, OSHA reviewed the full datasets provided by TSI as part of the review of the study protocols, and no commenters asked to see the datasets. In summary, OSHA finds that the public comments did not identify any significant shortcomings in the way that the results of the three journal articles were presented or interpreted.

3. Did the three studies treat outliers appropriately in determination of the exclusion zone?

While OSHA disagreed with the studies' omissions of outliers in calculating exclusion zones, OSHA recalculated exclusion zones with the outlier data included, and the results of the re-analysis did not change any of the studies' conclusions. In addition, NIOSH considered the study authors' identification of outliers to be “a reasonable method for diagnosing/identifying outliers” (OSHA-2015- 0015-0031). Finally, no commenters expressed concern about the treatment of outliers. OSHA concludes that the treatment of outliers in the studies did not undermine any of the studies' results or conclusions.

4. Will the two proposed protocols generate reproducible fit testing results?

Some commenters questioned the reproducibility of fit testing results using the two proposed protocols (OSHA-2015-0015-0022, OSHA-2015-0015-0042), but did not offer any compelling data or research suggesting their non-reproducibility. One of these commenters had concerns based on NIOSH's recommendation that OSHA (OSHA-2015-0015-0042) conduct additional research to gather evidence for a more informed decision. The commenter stated:

While additional research is always valuable, OSHA agrees with NIOSH that the proposed protocols are anticipated to generate reproducible results. The proposed protocols were evaluated based on the approach specified in the ANSI annex, which provides a specific procedure for evaluating fit test methods “against the current body of knowledge” and is considered a valid method by much of the industrial hygiene community. Having met the criteria of the ANSI annex, OSHA concludes that the proposed protocols will generate reproducible fit testing results.

5. Will the two proposed protocols reliably identify respirators with unacceptable fit as effectively as the quantitative fit testing protocols, including the OSHA-approved standard PortaCount® protocol, already listed in appendix A of the Respiratory Protection Standard?

Several commenters questioned not only the acceptability of the proposed protocols, but also the validity of the original ambient aerosol particle counting quantitative method already accepted by OSHA and listed in appendix A (OSHA-2015-0015-0022, OSHA-2015-0015-0026, OSHA-2015-0015-0027, OSHA-2015-0015-0029). Some of these commenters were also of the opinion that the CNP-based fit testing methods are superior to other quantitative fit testing methods. One commenter (OSHA-2015-0015-0042) stated that the following NIOSH “statement raises major concerns to the ability & proven accuracy of this proposed protocol to identify respirators with unacceptable fit”:

The validity of the original OSHA-approved ambient aerosol CNC fit testing protocol was never under question in this rulemaking. Appendix A of OSHA's Respiratory Protection Standard states that quantitative fit testing using ambient aerosol as the test agent and appropriate instrumentation (condensation nuclei counter) to quantify the respirator fit has “been demonstrated to be acceptable.” In addition, the members of the ANSI/AIHA Z88.10 “Respirator Fit Testing Methods” committee, who represent many of the nation's leading respiratory protection experts, opted to retain, rather than reject, this method as an acceptable quantitative fit testing method when they updated the national consensus standard in 2010. Furthermore, the proposed protocols were evaluated using the method described in the ANSI annex, which does not require a statistical comparison against the CNP method (OSHA-2015-0015-0007). Likewise, OSHA's Respiratory Protection Standard does not require that a new fit testing protocol be compared to the CNP method, or any other specific fit testing method. Moreover, just as OSHA does not rank specific makes and models of respirators, OSHA also does not rank fit testing methods. Each fit testing method has its own advantages and disadvantages.

In summary, OSHA determined that the new protocols met the sensitivity, specificity, predictive value, and other criteria outlined in the ANSI annex and will, therefore, provide employees with protections comparable to protections afforded to them by the reference method, which consisted of the standard OSHA exercises listed in Section I.A.14 of appendix A of the Respiratory Protection Standard, minus the grimace exercise, in the same order as described in the standard ( i.e., normal breathing, deep breathing, head side-to-side, head up-and-down, talking, bending over, normal breathing). These are the same test exercises, minus the grimace, that are utilized for both the CNC and CNP protocols. OSHA concluded that it was reasonable to remove the grimace exercise from the reference method during the method comparison testing, because its inclusion would unpredictably impact respirator fit within each pair of data comparing the current and new fit test protocols (see Question #10 below for a more detailed discussion).

6. Did the protocols in the three studies meet the sensitivity, specificity, predictive value, and other criteria contained in the ANSI/AIHA Z88.10-2010, Annex A2, Criteria for Evaluating Fit Test Methods?

One commenter stated that evaluating the sensitivity of the new protocols “presents a quandary because the sensitivity of the standard PortaCount protocol has itself not been established” (OSHA-2015-0015-0022). As discussed under question #5, the validity of the original OSHA-approved ambient aerosol CNC fit testing protocol is not at issue in this rulemaking.

OSHA's evaluation of the proposed protocols determined that they met the criteria outlined in the ANSI annex (see sections A-B above). In addition, NIOSH stated that their “review determined that the three methods met the criteria contained in the ANSI/AIHA Z88.10-2010, Annex A2” (OSHA-2015-0015-0031). Another commenter agreed that “the submitted request has followed the defined procedures and the results fit within the statistical limits set forth in ANSI Z88.10-2010” (OSHA-2015-0015-0035). Furthermore, OSHA determined that the public comments did not provide any substantive data or information suggesting that the proposed protocols in the three studies did not meet the sensitivity, specificity, predictive value, and other criteria contained in the ANSI annex.

7. Are the specific respirators selected in the three studies described in the peer-reviewed journal articles representative of the respirators used in the United States?

One commenter questioned the “very small sample of the wide range of tight sealing respirators that were used in the [studies]” (OSHA-2015-0015-0029), and another expressed that “the small sample size of respirators chosen for testing lends itself to being less than ideal” (OSHA-2015-0015-0040). However, neither commenter provided specific recommendations or statistical data regarding the numbers and types of respirators that should have been selected or why. Further, the industrial hygiene research community does not require a specified sample size of respirators to assess fit testing protocols. Finally, had the respirator sample size been too small to produce reliable results, the studies likely would not have been accepted for publication in a peer-reviewed journal.

One commenter questioned why the Richardson studies included only filtering facepiece respirators without exhalation valves, noting that many users opt to wear filtering facepiece respirators with exhalation valves for comfort reasons (OSHA-2015-0015-0026). But an exhalation valve does not affect respirator fit. While the study authors did not explain how they selected the respirator models and designs, OSHA has determined that the public comments did not identify any significant shortcomings in respirator selection and believes that the models and designs selected for the three experiments were appropriately representative.

8. Does the elimination of certain fit test exercises (e.g., normal breathing, deep breathing, talking) required by the existing OSHA-approved standard PortaCount® protocol impact the acceptability of the proposed protocols?

Several commenters expressed concern over removing certain fit test exercises (OSHA-2015-0015-0021, OSHA-2015-0015-0024, OSHA-2015-0015-0025, OSHA-2015-0015-0029, OSHA-2015-0015-0032, OSHA-2015-0015-0033, OSHA-2015-0015-0038, OSHA-2015-0015-0041), but did not provide any peer-reviewed data or published research to support their opinions. Three commenters (OSHA-2015-0015-0021, OSHA-2015-0015-0025, OSHA-2015-0015-0032) expressed concern about removing the talking exercise, because they had experienced fit test failures during the talking exercise when fit testing workers. Another commenter felt that “it doesn't make sense to eliminate [the talking] exercise simply because it wasn't the worst contributing exercise with poor fitting respirators” (OSHA-2015-0015-0033). A third suggested retaining the head side-to-side, head up-and-down, and talking exercises because he believes they are currently the most rigorous exercises (OSHA-2015-0015-0024).

Another commenter suggested that “the conclusion to eliminate Normal Breathing 2 (NB2) from the Fast Full Protocol is extremely subjective” and questioned how “NB2 [normal breathing #2] could be eliminated and UD [moving head up and down] kept if there is no correlation with the study data?” (OSHA-2015-0015-0038). This commenter suggested increasing the purge time to improve the ability of the NB2 exercise to detect poor fits. Regarding this question, OSHA has concluded that TSI properly excluded the second normal breathing exercise. In TSI's study of the Fast-Full method, the second normal breathing exercise had the lowest fit factor 19% of the time for poor-fitting respirators. While this score normally indicates an exercise was effective at detecting poor-fitting respirators, TSI concluded that score was anomalous because the corresponding score for the first normal breathing (NB1) exercise was 0%. TSI reasoned the 19% score was a result of particles introduced into the facepiece during the preceding (bending over) exercise that were not purged (OSHA-2015-0015-0008). Increasing the purge time to clear such particles would not, as the commenter suggests, improve the ability of the NB2 exercise to detect poor fits. Instead, NB2 would likely be as ineffective as NB1, which was never the lowest fit factor for any poor-fitting respirators. This is also supported by the fact that the NB1 and NB2 exercises produced the lowest fit factors only 2% and 5% of the time, respectively, for good-fitting respirators.

One commenter noted that “[e]limination of the normal breathing, deep breathing, and talking fit test exercises from the proposed Fast protocols has significant potential for adverse impact on PortaCount fit test results in the real world” (OSHA-2015-0015-0022). With respect to normal breathing and talking, the commenter noted that several studies not mentioned by the three Richardson studies indicate that the first normal breathing exercise fit factor is typically lower than fit factors from all subsequent exercises and that the talking exercise also often results in a lower fit factor. But this commenter did not provide any basis to believe eliminating these exercises will put workers at risk. Indeed, he conceded that “respirator donning has a greater effect on respirator fit than do fit test exercises” and “the lower fit factors produced by the talking exercise appear to be more consistent with sampling artifact than with actual exercise dynamics.” And, as TSI explained, fit factors for the second normal breathing exercise are likely to be contaminated by prior exercises (OSHA-2015-0015-0008). Finally, this commenter offered no data or published information that suggest deep breathing is more rigorous than other exercises or that eliminating deep breathing will put workers at risk.

One commenter (OSHA-2015-0015-0029) stated that “our experience strongly suggests that the Deep Breathing and Talking Exercises are frequently the exercises that see the lowest fit factors calculated and often are `THE Exercises' which determine whether a respirator wear will achieve a Pass or Failure following the completion of the fit test series of exercises.” He further suggested “a more thorough evaluation of this change by a third party such as NIOSH-NPPTL. . . .” Another commenter requested that a review of the studies be performed by an independent third party (OSHA-2015-0015-0040). NIOSH/NPPTL did in fact review and evaluate the studies. In the comments NIOSH submitted to OSHA, NIOSH did not express any concern over the removal of the talking exercise and ultimately “recommend[ed] that OSHA accept the three protocols” (OSHA-2015-0015-0031).

Regarding all these comments, the industrial hygiene community has not come to a consensus as to which test exercises must be used in a new fit testing protocol. Neither the ANSI annex nor OSHA's appendix requires any specific test exercise(s) be used in a new fit testing protocol. Further, in 2004, OSHA approved an abbreviated version of the CNP protocol, called the CNP REDON protocol, which excludes the deep breathing and talking exercises, and includes only the facing forward (same as normal breathing), bending over, and head shaking exercises. In sum, the information submitted in the public comments did not convince OSHA that the elimination of the deep breathing and talking exercises adversely impacted the acceptability of the proposed protocols, which met the sensitivity, specificity, predictive value, and other criteria contained in the ANSI annex.

9. Is the test exercise, jogging-in-place, that has been added to the Fast-Full and Fast-Half protocols appropriately selected and adequately explained? Should the jogging exercise also be employed for the Fast-FFR protocol? Is the reasoning for not replacing the talking exercise with the more rigorous jogging exercise in the Fast-FFR protocol (as was done in Fast-Full and Fast-Half) adequately explained?

One commenter was of the opinion that “[t]he jogging exercise, while rigorous, is not representative of real-life civilian activities” (OSHA-2015-0015-0024). NIOSH stated that it would have liked to have seen references to support that the jogging-in-place exercise used in the protocols for elastomeric respirators was aggressive in evaluating the respirator seal. However, this did not prevent NIOSH from recommending that OSHA approve the proposed protocols (OSHA-2015-0015-0031). Furthermore, as stated above under question #8, the industrial hygiene community has not come to a consensus as to which test exercise(s) must be included in new fit testing protocols. More importantly, neither the ANSI annex nor OSHA's appendix requires that any specific test exercise(s) be used in a new fit testing protocol.

10. Was it acceptable to omit the grimace from the reference method employed in the studies evaluating performance of the proposed fit testing protocols? Is it appropriate to exclude the grimace completely from the proposed protocols, given that it is not used in the calculation of the fit factor result specified under the existing or proposed test methods? If not, what other criteria could be used to assess its inclusion or exclusion?

One commenter (OSHA-2015-0015-0026) stated that he “seriously question[s] the choice of the study and protocol authors in removing the Grimace exercise.” While he “concur[s] with their statement that it cannot be consistently applied and with their statement that the fit factor if measured should not be used in calculation of the fit factor,” his “interpretation is that the importance of the grimace is not in the fit factor achieved during this step of the protocol but instead in the ability of the mask to re-seal after this exercise which goes to the respirator['s] proper fit.”

While NIOSH (OSHA-2015-0015-0031) “recommends that the grimace test be included in the abbreviated protocols when used in the workplace since it is part of the currently accepted protocols,” NIOSH agrees that the new “protocols provide a valid reason for not including [the grimace] in the method comparison testing since it would add a non-controlled variable.” Similarly, another commenter stated:

OSHA agrees that it is reasonable to remove the grimace exercise from the reference method during the method comparison testing, because its inclusion would unpredictably impact respirator fit. Some respirator fit test protocols include the grimace exercise because it is believed that it will unseat the respirator facepiece; whether this occurs is assessed, however, only during the subsequent exercise—fit measured during the grimace exercise is not included in the calculation of overall fit. Because method comparison requires a range of fit factors (from poor- to well-fitting respirators), OSHA believes that excluding the short grimace exercise allows for a more consistent assessment of fit between the reference and new fit test protocols.

Finally, neither the ANSI annex nor the OSHA appendix specifies which exercises must be used in a new fit testing protocol. The 2010 ANSI Z88.10 standard specifically considers the grimace exercise to be elective for the particle-counting instrument quantitative fit test procedure that it describes (see Table I). And although OSHA requires the grimace exercise as part of the original ambient aerosol CNC protocol, OSHA approved an abbreviated CNP REDON protocol in 2004 that excluded the grimace exercise among four other exercises. As such, OSHA concludes that it is not necessary to add the grimace exercise to the proposed protocols.

11. The protocols in the three studies specify that participants take two deep breaths at the extreme of the head side-to-side and head up-and-down exercises and at the bottom of the bend in the bend-forward exercise. According to the developers of these protocols, the deep breaths are included to make the exercises more rigorous and reproducible from one subject to the next. Are these additional breathing instructions adequately explained in the studies and in the proposed amendment to the standard? Are they reasonable and appropriate?

OSHA received no comments regarding these questions, which suggests that the breathing instructions were adequately explained in both the studies and in the proposed amendment to the standard, and that stakeholders were not concerned about this issue.

12. Does OSHA's proposed regulatory text for the two new protocols offer clear instructions for implementing the protocols accurately?

Neither TSI nor any commenters expressed concern about the clarity of OSHA's proposed regulatory text instructions for implementing the protocols. In the absence of such comments, the only changes that OSHA has made to the proposed regulatory text include an expansion of the titles of Tables A-1 and A-2 to match the names of the new protocols exactly. OSHA did this solely for clarity, so employers correctly correlate these two new tables with the two new proposed protocols.

Several commenters expressed miscellaneous concerns that did not fall directly under any of OSHA's specific questions for public comment. OSHA addresses each in turn. One commenter was not in favor of any quantitative fit testing methods because, in his view, qualitative fit tests are more convincing to the respirator wearers themselves (OSHA-2015-0015-0017):

Another commenter was concerned about shortening the protocols to less than an eight-minute period, because she thought that symptoms of claustrophobia/panic attacks might not manifest before eight minutes (OSHA-2015-0015-0021). However, the risk of claustrophobia/panic attacks is already addressed when the wearer is required, under § 1910.134(e)(1) of the Respiratory Protection Standard, to undergo a mandatory medical evaluation “to determine the employee's ability to use a respirator, before the employee is fit tested or required to use the respirator in the workplace.” And the mandatory medical questionnaire in Appendix C of the standard includes a question regarding claustrophobia. In addition, OSHA is unaware of this having been an issue for respirator wearers fit tested using the CNP REDON protocol, which also lasts less than eight minutes and was approved by OSHA in 2004.

Two commenters who favored shorter protocols expressed interest in making the new protocols available on all ambient aerosol CNC-based fit testing instruments, particularly the older PortaCount® (model 8020) machines (OSHA-2015-0015-0028, OSHA-2015-0015-0030). OSHA notes that the new protocols are not restricted to any particular testing instrument because OSHA only approves fit testing protocols, not specific fit testing machines. 12 OSHA has no authority to require specific fit testing machines or models for new protocols. Employers must contact the manufacturers of CNC fit testing machines to determine which models support the new protocols.

After reviewing the comments submitted to the record, OSHA finds that the two proposed modified ambient aerosol CNC quantitative fit testing protocols are supported by peer-reviewed studies that were conducted according to accepted experimental design practices and principles and that produced results that were properly, fully, and fairly presented and interpreted. In addition, based on the peer-reviewed studies and comments submitted to the record, OSHA finds that the two proposed protocols meet the sensitivity, specificity, predictive value, and other criteria contained in the ANSI annex. Moreover, the proposed protocols met the criteria of the ANSI annex, and in the absence of any compelling data or research in the record that would suggest that the proposed protocols would not generate reproducible fit testing results, OSHA concludes that the proposed protocols will generate reproducible fit testing results. In summary, OSHA concludes that the two proposed protocols are sufficiently accurate and reliable to approve and include in appendix A of its Respiratory Protection Standard.

The original TSI PortaCount® machine (model 8020) could only be used to fit test respirators equipped with ≥99% efficient filter media ( i.e., N-, R-, or P-99 and 100 NIOSH filter designations). In 1998, TSI introduced the N95-Companion TM Technology, which, when combined with the PortaCount® 8020 model, could be used to fit test respirators equipped with <99% efficient filter media ( e.g., N95 NIOSH filter designation). TSI no longer manufactures the 8020 model, which was replaced by a second generation of PortaCount® instruments (models 8030 and 8038). TSI introduced a third generation of PortaCount® instruments (models 8040 and 8048) in November 2017. Models 8030 and 8040 can only test the most efficient filters ( i.e., 99 and 100 NIOSH filter designations), while models 8038 and 8048, which include the N95 Companion TM Technology already built into the machine, can test any type of filter by selecting the appropriate operating mode. Because employers are sometimes confused by this distinction, OSHA considered using this rulemaking to propose additional language to Part I.C.3 of appendix A of the Respiratory Protection Standard to reflect this technological development. The additional language proposed by OSHA did not alter the fit testing protocol or impose any new requirements on employers; it was merely intended for clarification purposes.

One commenter expressed concern over the use of the brand name “Portacount®” within the regulatory text, stating that “[t]his seems to exclude other potential CNC providers” (OSHA-2015-0015-0024). Regarding this comment, the original OSHA-approved ambient aerosol CNC protocol is often commonly referred to as the PortaCount® protocol because of the name of the CNC machines manufactured by the company ( i.e., TSI) that proposed the original protocol. OSHA is aware of only one other manufacturer that produces CNC instrumentation that is sold in the U.S. at this time. This new CNC instrumentation was only recently introduced into the market, so OSHA estimates that the overwhelming majority of the CNC instruments used in the U.S. at this time are still TSI PortaCount® machines. As such, OSHA determined that it is in the best interests of worker health and safety to retain the PortaCount® name within the regulatory text, as it has appeared in appendix A since 1998. This language is not intended to be exclude other manufacturers. It is intended merely to reflect that TSI's machines are those typically used for this test at this point in time. OSHA does not approve any safety equipment or require employers to use specific brands of safety equipment. However, it does sometimes refer to company or brand names when it is in the interest of safety and health. For example, appendix A of the Respiratory Protection Standard also includes the brand name ( i.e., Bitrex®) for the substance ( i.e., denatonium benzoate solution aerosol) overwhelmingly used for one of the OSHA-approved qualitative fit testing protocols. In addition, appendix A refers to the name of the company ( i.e., Occupational Health Dynamics) that proposed the original CNP protocol and manufacturers CNP instrumentation.

OSHA has, however, decided not to add the clarifying information about the different types of PortaCount® machines, due to commenter concerns that the inclusion of such information could create the appearance of a product endorsement. Since OSHA approves fit testing protocols rather than machines, OSHA feels that employers can contact fit testing instrument manufacturers for product specificity and capabilities.

OSHA's Respiratory Protection Standard is based on evidence that fit testing is necessary to ensure proper respirator fit for employees, which protects them against excessive exposure to airborne contaminants in the workplace. Employers covered by this revision already must comply with the fit testing requirements specified in paragraph (f) of OSHA's Respiratory Protection Standard at 29 CFR 1910.134.

OSHA has determined that the additional modified ambient aerosol CNC protocols provide employees with protection that is comparable to the protection afforded them by the existing fit testing provisions. The additional modified ambient aerosol CNC protocols do not replace existing fit testing protocols, but instead are alternatives to them. Therefore, OSHA finds that the final standard does not directly increase or decrease the protection afforded to employees, nor does it increase employers' compliance burden. The additional modified ambient aerosol CNC protocols reduce the total fit test duration, and therefore may reduce the compliance burden for employers that elect to use one of these protocols.

The rule is not economically significant under Executive Order 12866 (58 FR 51735) or a “major rule” under Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 804). The rule imposes no additional costs on any private- or public-sector entity and is not a significant or major rule under Executive Order 12866 or other relevant statutes or executive orders. This rulemaking increases employers' flexibility in choosing fit testing methods for employees, and the final rule does not require an employer to update or replace its current fit testing method(s) if the fit testing method(s) currently in use meets existing standards. Furthermore, because the rule offers additional options that employers would be expected to select only if those options did not impose any net cost burdens on them, the rule will not have a significant impact on a substantial number of small entities.

OSHA received several comments in response to the NPRM related to the time savings anticipated by the proposal. As discussed in the “Summary and Explanation,” a number of commenters noted that time savings of the proposed fit testing protocols would increase efficiency and be substantial when aggregated across a large number of employees (OSHA-2015-0015-0018, OSHA-2015-0015-0020). No comments indicated that the time savings estimates would be significantly different from those put forth in the Preliminary Economic Analysis (PEA). 13 As a result, OSHA has not changed its methodology for calculating the potential cost savings of implementing the new protocols.

The new quantitative fit testing (QNFT) protocols will provide employers additional options to fit test their employees for respirator use. While OSHA approves fit testing protocols rather than fit testing machines, OSHA understands that, currently, the market for fit testing machines using the original ambient aerosol CNC protocol is dominated by TSI's PortaCount® machines (Models 8020, 8030, 8038, 8040, 8048). 14 As such, OSHA's Final Economic Analysis (FEA) focuses specifically on TSI's PortaCount® machines. Employers already using the original ambient aerosol CNC protocol with a PortaCount® machine (with the exception of the now-discontinued 8020) may switch from the original ambient aerosol CNC protocol to the new protocols. OSHA estimates switching saves approximately 5 minutes per fit test, and grants the employer corresponding cost savings.

According to TSI, “[e]xisting owners of the PortaCount® Respirator Fit Tester Pro Model 8030 and/or PortaCount® Pro+ Model 8038 will be able to utilize the new protocols without additional expense. It will be necessary for fit testers to obtain a firmware and FitPro software upgrade, which TSI will be providing as a free download. As an alternative to the free download, PortaCount® Models 8030 and 8038 returned for annual service will be upgraded without additional charge. Owners of the PortaCount® Plus Model 8020 with or without the N95-Companion TM Technology (both discontinued in 2008) will be limited to the current 8-exercise OSHA fit test protocol” (OSHA-2015-0015-0010). 15 There are approximately 12,000 Model 8030 or 8038 units in the field. 16 Existing PortaCount® users may adopt the new protocols with minimal effort: The fit tester will be able to select the new protocol after taking an estimated less than five minutes to download TSI's firmware and software updates. The individual being fit tested is also likely to learn the new protocols with minimal time. In fact, information about the new protocols could be imparted during the annual training mandated by OSHA's respiratory protection rule (OSHA-2015-0015-0012). As a practical matter, the new protocols contain fewer exercises requiring mastery. And Part I.A.12 of appendix A of OSHA's Respiratory Protection Standard already requires the fit tester to describe the fit test to the respirator wearer, regardless of which fit test it is or how often it is used. Thus, there should be no additional burden to the employer or employee.

OSHA anticipates many employers who currently use the original ambient aerosol CNC protocol will adopt the new protocols because they could be adopted at negligible cost to the employer and would take less time to administer. OSHA expects that the new protocols are less likely to be adopted by employers who currently perform fit testing using other quantitative or qualitative fit tests because of the significant equipment and training investment that they already have made to administer these fit tests. For example, OSHA estimates, based on information from TSI, that switching from qualitative to quantitative fit testing would require upfront costs of $8,700 to $12,000 per machine (OSHA-2015-0015-0012).

OSHA has estimates of the number of users of the PortaCount® technology at the establishment level, both from the manufacturer and from the 2001 NIOSH Respirator Survey. However, what is not known is how many respirator wearers, that is, employees, are fit tested using a PortaCount® device. As described in the PEA, OSHA expects that economies of scale will apply in this situation—larger establishments will be more likely to encounter situations needing QNFT, but will also have more employees over which to spread the capital costs. OSHA received no comments about its understanding of employer size in relation to QNFT use. Once employers have invested capital in a quantitative fit testing device, they have more of an incentive to perform QNFT in a given situation, even if not technically required to use QNFT in every situation. Also, some QNFT devices are acquired by third parties, or “fit testing houses,” that provide fit testing services to employers. In short, as put forth in the PEA, OSHA believes that employers using PortaCount® QNFT will process more respirator wearers than the average establishment. OSHA received no comments about this conclusion.

As set forth in the PEA, if one started with an estimate of 12,000 establishments using PortaCount® models 8030 and 8038 annually for all of their employees and assumed an average of 100 respirator wearers fit tested annually per establishment, this yielded an estimate of 1.2 million respirator wearers that could potentially benefit from the new QNFT protocols. 17 Alternatively, as also set out in the PEA, a similar estimate would have been obtained if one assumed, employing data from the 2001 NIOSH Respirator Survey, that 50 percent of the devices requiring QNFT (such as full-facepiece elastomeric negative pressure respirators) use PortaCount® currently, as well as 25 percent of half-mask elastomeric respirators, and 10 percent of filtering facepieces. 18 These estimates in the PEA were not questioned in public comment. In the intervening period between the PEA and the FEA, the total number of employees and estimated respirator wearers increased somewhat, raising the estimated number of respirator wearers affected by the rulemaking, based on survey data, to approximately 1.3 million.

If applied to approximately 1.3 million respirators wearers, an estimated savings of 5 minutes per respirator wearer would equal over 100,000 hours of employee time saved annually. Consistent with Department of Labor policy for translating the labor time savings into dollar cost savings for this FEA, OSHA included an overhead rate when estimating the marginal cost of labor in its primary cost calculation. Overhead costs are indirect expenses that cannot be tied to producing a specific product or service. Common examples include rent, utilities, and office equipment. Unfortunately, there is no general consensus on the cost elements that fit this definition. The lack of a common definition has led to a wide range of overhead estimates. Consequently, the treatment of overhead costs needs to be case-specific. OSHA adopted an overhead rate of 17 percent of base wages, consistent with overhead rates used for other regulatory compliance rules. 19 For example, this is consistent with the overhead rate used for sensitivity analyses in the 2017 Improved Tracking FEA and the FEA in support of OSHA's 2016 final standard on Occupational Exposure to Respirable Crystalline Silica. For example, in this case, to calculate the total labor cost for a typical respirator wearer, based on the mean worker wage, three components are added together: Base wage ($23.86) + fringe benefits ($10.42—43.7% of $23.86);  20 and the applicable overhead costs ($4.06—17% of $23.86). This results in an hourly labor cost of a respirator wearing employee to $38.34. This implies an estimated cost savings of $4.1 million attributable to the adoption of the new fit testing protocols.

Because the $4.1 million represents annual cost savings, the final estimate is the same when discounted at either 3 or 7 percent. For the same reason, when the Department of Labor uses a perpetual time horizon to allow for cost comparisons under E.O. 13771, the annualized cost savings of the final rule are also $4.1 million with 7 percent discounting. As indicated earlier, this final estimate includes an overhead factor in the labor costs. This is estimated to add an additional savings of approximately 12%, or over $400,000, on what would have been an estimated savings of $3.6 million.

In addition to costs related to the respirator wearer's time, there will also likely be time savings for the person administering the fit tests. However, OSHA did not include this cost savings element in the PEA because it lacked specific empirical information on this point at the time of the proposal. OSHA requested comment on this question, but did not receive any. While OSHA believes this element of the cost savings is potentially substantial, it is not a critical element for the FEA, as it is simply a question of how large the cost savings are, and not required, for example, to determine economic feasibility. Therefore, OSHA is maintaining in the final analysis the same analytical approach used in the PEA. 21

In addition, as discussed, this FEA does not account for potential conversions from testing methods other than the original ambient aerosol CNC protocol. While such conversions could further increase time and cost savings, OSHA cannot predict the number of conversions with confidence. In short, while certain factors could change the precise cost savings estimates in the FEA, OSHA believes its estimates reasonably capture the direction and order of magnitude of the rulemaking's economic effects.

In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (as amended), OSHA has examined the regulatory requirements of the final rule to determine whether these requirements will have a significant economic impact on a substantial number of small entities. This rule will impose no required costs and could provide a cost savings in excess of $4 million per year to regulated entities. While measureable in the aggregate, these savings will be dispersed widely, and therefore are not estimated to have a substantial economic impact on any small entity, although the impacts are estimated to be positive. The Assistant Secretary for Occupational Safety and Health therefore certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

The Paperwork Reduction Act (PRA) requires that agencies obtain approval from OMB before conducting any collection of information (44 U.S.C. 3507). The PRA defines “collection of information” to mean “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format” (44 U.S.C. 3502(3)(A)).

In accordance with the PRA, 44 U.S.C. 3506(c)(2), OSHA solicited public comments on proposed revisions to the Respiratory Protection Standard Information Collection Request (ICR) (paperwork burden hour and cost analysis) for the information collection requirements associated with the Additional PortaCount® Quantitative Fit-Testing Protocols: Amendment to Respiratory Protection Standard proposed rule (81 FR 69747). The Department submitted this ICR to OMB for review in accordance with 44 U.S.C. 3507(d) on October 7, 2016. A copy of the ICR for the proposed rule is available to the public at: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201511-1218-005.

On November 22, 2016, OMB issued a Notice of Action withholding its approval of the ICR. OMB requested that, “[p]rior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.”

No public comments were received specifically in response to the proposed ICR submitted to OMB for review. However, several public comments submitted in response to the NPRM, described earlier in this preamble, substantively addressed provisions containing collections of information and included information relevant to the burden hour and costs analysis. These comments are addressed in the preamble, and OSHA considered them when it developed the revised ICR associated with this final rule. See the comment analysis in section II.D above.

Under the PRA, a Federal agency cannot conduct or sponsor a collection of information unless it is approved by OMB under the PRA, and the collection of information notice displays a currently valid OMB control number (44 U.S.C. 3507(a)(3)). Also, notwithstanding any other provision of law, no employer shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number (44 U.S.C. 3512). The revised information collection requirements found in the final rule are summarized below.

The Department of Labor has submitted the final ICR concurrent with the publication of this final rule. The ICR contains a full analysis and description of the burden hours and costs associated with the information collection requirements of the final rule to OMB for approval. A copy of the ICR is available to the public at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201904-1218-002. OSHA will publish a separate notice in the Federal Register announcing the results of OMB's review. That notice will also include a list of OMB-approved information collection requirements and the total burden hours and costs imposed by the final rule.

The additional protocols adopted in this final rule revise the information collection in a way that reduces existing burden hours and costs. In particular, the information collection requirement specified in paragraph (m)(2) of OSHA's Respiratory Protection Standard, at 29 CFR 1910.134, states that employers must document and maintain the following information on quantitative fit tests administered to employees: The name or identification of the employee tested; the type of fit test performed; the specific make, model, style, and size of respirator tested; the date of the test; and the test results. The employer must maintain this record until the next fit test is administered. While the information on the fit test record remains the same, the time to obtain the necessary information for the fit test record is reduced since the additional PortaCount® protocols will take an employer less time to administer than those currently approved in appendix A of the Respiratory Protection Standard. As a result, the total estimated burden hours decrease by 201,640 hours, from 7,622,100 to 7,420,460 hours. This decrease is a result of the more efficient protocols established under the final rule. OSHA accounts for this burden under the Information Collection Request, or paperwork analysis, for the Respiratory Protection Standard (OMB Control Number 1218-0099). Note that OSHA cannot require compliance with the information collection requirements for the new information collection in this final rule until OMB has approved the information collection requirements.

Title of Collection: Respiratory Protection Standard (29 CFR1910.134).

OMB Control Number: 1218-0099.

Affected Public: Private Sector—business or other for-profits.

Total Estimated Number of Respondents: 24,710,469.

Total Estimated Number of Responses: 25,042,236.

Total Estimated Annual Time Burden Hours: 7,420,460.

Total Estimated Annual Other Burden: $316,906,665.

OSHA reviewed this rulemaking according to the Executive Order on Federalism (E.O. 13132, 64 FR 43255, Aug. 10, 1999), which requires that Federal agencies, to the extent possible, refrain from limiting state policy options, consult with states before taking actions that would restrict states' policy options and take such actions only when clear constitutional authority exists and the problem is of national scope. The Executive Order provides for preemption of state law only with the expressed consent of Congress. Federal agencies must limit any such preemption to the extent possible.

Under section 18 of the Occupational Safety and Health Act (the “Act,” 29 U.S.C. 651 et seq. ), Congress expressly provides that states may adopt, with Federal approval, a plan for the development and enforcement of occupational safety and health standards (29 U.S.C. 667). OSHA refers to states that obtain Federal approval for such a plan as “State Plan states.” Occupational safety and health standards developed by State Plan states must be at least as effective in providing safe and healthful employment and places of employment as the Federal standards. Subject to these requirements, State Plan states are free to develop and enforce under state law their own requirements for occupational safety and health standards. With respect to states that do not have OSHA-approved plans, OSHA concludes that this standard conforms to the preemption provisions of the Act. Section 18 of the Act prohibits states without approved plans from issuing citations for violations of OSHA standards. OSHA finds that the rule does not expand this limitation. Therefore, for States that do not have approved occupational safety and health plans, the rule will not affect the preemption provisions of Section 18 of the Act.

OSHA's rulemaking to adopt additional fit testing protocols under its Respiratory Protection Standard at 29 CFR 1910.134 is consistent with Executive Order 13132 because the problems addressed by these fit testing requirements are national in scope. OSHA concludes that the fit testing protocols adopted by this rulemaking provide employers in every state with procedures that will assist them in protecting their employees from the risks of exposure to atmospheric hazards. In this regard, the rule offers thousands of employers across the nation an opportunity to use additional protocols to assess respirator fit among their employees. Therefore, the rule provides employers in every state with an alternative means of complying with the fit testing requirements specified by paragraph (f) of OSHA's Respiratory Protection Standard.

Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State Plan states to adopt an OSHA standard, or to develop and enforce an alternative that is at least as effective as the OSHA standard. However, the new fit testing protocols adopted by this rulemaking provide employers with alternatives to the existing fit testing protocols specified in the Respiratory Protection Standard; therefore, the alternative is not, itself, a mandatory standard. Accordingly, states with OSHA-approved State Plans are not obligated to adopt the additional fit testing protocols adopted here. Nevertheless, OSHA strongly encourages them to adopt the final provisions to provide additional compliance options to employers in their states.

In summary, this rulemaking complies with Executive Order 13132. In states without OSHA-approved State Plans, this rulemaking limits state policy options in the same manner as other OSHA standards. In State Plan states, this rulemaking does not significantly limit state policy options.

Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State Plan states to adopt mandatory standards promulgated by OSHA, or to develop and enforce an alternative that is at least as effective as the OSHA standard. However, as noted in the previous section of this preamble, states with OSHA-approved State Plans are not obligated to adopt the provisions of this final rule. Nevertheless, OSHA strongly encourages them to adopt the final provisions to provide compliance options to employers in their States. In this regard, OSHA concludes that the fit testing protocols adopted by this rulemaking provide employers in the State Plan states with procedures that protect the safety and health of employees who use respirators against hazardous airborne substances in their workplace at least as well as the quantitative fit testing protocols in appendix A of the Respiratory Protection Standard.

There are 28 states and U.S. territories that have their own OSHA-approved occupational safety and health programs called State Plans. The following 22 State Plans cover state and local government employers and private-sector employers: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The following six State Plans cover state and local government employers only: Connecticut, Illinois, Maine, New Jersey, New York, and the Virgin Islands.

OSHA reviewed this rulemaking according to the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501-1507) and Executive Order 12875 (58 FR 58093 (1993)). As discussed above in section III.B of this preamble (“Final Economic Analysis and Regulatory Flexibility Certification”), OSHA has determined that the rule imposes no additional costs on any private-sector or public-sector entity. The substantive content of the rule applies only to employers whose employees use respirators for protection against airborne contaminants, and compliance with the protocols contained in the final rule are strictly optional for these employers. Accordingly, the final rule does not require additional expenditures by either public or private employers. Therefore, this rulemaking is not a significant regulatory action within the meaning of Section 202 of the UMRA, 2 U.S.C. 1532.

As noted above under Section E (“State Plan States”) of this preamble, OSHA standards do not apply to state or local governments except in states that have voluntarily elected to adopt an OSHA-approved State Plan. Consequently, this final rulemaking does not meet the definition of a “Federal intergovernmental mandate” (see 2 U.S.C. 658(5)). Therefore, for the purposes of the UMRA, the Assistant Secretary for Occupational Safety and Health certifies that this rulemaking does not mandate that state, local, or tribal governments adopt new, unfunded regulatory obligations, or increase expenditures by the private sector of more than $100 million in any year.

Section 6(b)(8) of the Act (29 U.S.C. 655(b)(8)) requires OSHA to explain “why a rule promulgated by the Secretary differs substantially from an existing national consensus standard,” by publishing “a statement of the reasons why the rule as adopted will better effectuate the purposes of the Act than the national consensus standard.” The American National Standards Institute (ANSI) developed a national consensus standard on fit testing protocols (“Respirator Fit Testing Methods,” ANSI Z88.10-2001) as an adjunct to its national consensus standard on respiratory protection programs. ANSI/AIHA updated the Z88.10 standard in 2010 (“Respirator Fit Testing Methods,” ANSI Z88.10-2010) (OSHA-2015-0015-0007).

Paragraph 7.2 of ANSI/AIHA Z88.10-2010 specifies the requirements for conducting a particle-counting-instrument ( e.g., PortaCount®) quantitative fit test. The modified CNC protocols adopted by the final rule are variations of this national consensus standard's particle counting-instrument quantitative fit test procedures: The new protocols require the same 30-second duration for fit testing exercises, but not the same exercises as ANSI/AIHA. However, Annex A2 of ANSI/AIHA Z88.10-2010 recognizes that a universally accepted measurement standard for respirator fit testing does not exist and provides specific requirements for evaluating new fit testing methods. OSHA has concluded that the modified CNC protocols submitted by TSI meet the evaluation criteria outlined in ANSI/AIHA Z88.10-2010, Annex A2.

The Contract Work Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C. 3704), OSHA regulations governing the Advisory Committee for Construction Safety and Health (ACCSH) ( i.e., 29 CFR 1912.3), and provisions governing OSHA rulemaking ( i.e., 29 CFR 1911.10) require OSHA to consult with the ACCSH whenever OSHA proposes a rule involving construction activities. Specifically, 29 CFR 1911.10 requires that the Assistant Secretary provide the ACCSH with “any proposal of his own,” together with “all pertinent factual information available to him, including the results of research, demonstrations, and experiments.”

The addition of two quantitative fit test protocols to appendix A of OSHA's Respiratory Protection Standard affects the construction industry because it revises the fit testing procedures used in that industry (see 29 CFR 1926.103). Accordingly, OSHA provided the ACCSH members with TSI's application letter, supporting documents, and other relevant information, prior to the December 4, 2014 ACCSH meeting. OSHA explained its proposal to add new protocols to the ACCSH at that meeting, and the ACCSH unanimously approved proceeding with a proposed rule.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. Immediate action is needed to respond to the potential safety hazards created by the placement of multiple spans for the new Islands Expressway Bridge. The Coast Guard received information on August 27, 2019 regarding the operations beginning on September 18, 2019. The operation would begin before the rulemaking process would be completed. Because of the dangers posed by the placement of multiple spans, the safety zone is necessary to provide for the safety of persons, vessels, and the marine environment in the event area.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with the construction and placement of multiple spans.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The COTP Savannah has determined that potential hazards associated with the placement of multiple spans for the new Islands Expressway Bridge starting September 18, 2019, will be a safety concern for anyone within 1,000 feet of the north and south side of the Islands Expressway Bridge. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during bridge construction.

This rule establishes a safety zone from 8:00 a.m. on September 18, 2019 to 2:00 p.m. on September 20, 2019, 8:00 a.m. on September 23, 2019 to 2:00 p.m. on September 27, 2019, 8:00 a.m. on September 30, 2019 to 2:00 p.m. on October 4, 2019, 8:00 a.m. on October 14, 2019 to 2:00 p.m. on October 18, 2019, 8:00 a.m. on October 21, 2019 to 2:00 p.m. on October 22, 2019. The safety zone will cover all navigable waters within 1,000 feet on the north and south side of the Islands Expressway Bridge, Savannah, GA. Weather contingency days have been factored into this timeframe. If the safety zone is not enforced on weather contingency days, the Coast Guard will notify the public via Broadcast Notice to Mariners and will update the Local Notice to Mariners.

The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during placement of multiple spans for the new Islands Expressway Bridge. No vessel or person will be permitted to enter, transit through, anchor in, or remain within the safety zone without obtaining permission from the COTP or a designated representative.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. The safety zone is only in effect for navigable waters within 1,000 feet of the Islands Expressway Bridge on the north and south side during the placement of multiple spans for the new Islands Expressway Bridge. Vessels and persons seeking to enter, transit through, anchor in, or remain within the regulated area may seek authority from the COTP or a designated representative. The Coast Guard will provide notification of the regulated area to the local maritime community by Local Notice to Mariners, Broadcast Notice to Mariners via VHF-FM marine channel 16, and Marine Safety Information Bulletin release.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone during the placement of multiple spans for the new Islands Expressway Bridge. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

On March 12, 2008 (73 FR 16436), EPA promulgated an ozone NAAQS that revised the levels of the primary and secondary 8-hour ozone standards from 0.08 parts per million (ppm) to 0.075 ppm. See 73 FR 16436 (March 27, 2008). Pursuant to CAA section 110(a)(1), within three years after promulgation of a new or revised NAAQS (or shorter, if EPA prescribes), states must submit SIPs that meet the applicable requirements of section 110(a)(2). EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. One of the structural requirements of section 110(a)(2) is section 110(a)(2)(D)(i), which generally requires SIPs to contain adequate provisions to prohibit in-state emissions activities from having certain adverse air quality effects on neighboring states due to interstate transport of air pollution.

There are four sub-elements, or “prongs,” within section 110(a)(2)(D)(i) of the CAA. CAA section 110(a)(2)(D)(i)(I), also known as the “good neighbor” provision, requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from emitting any air pollutant in amounts that will contribute significantly to nonattainment, or interfere with maintenance, of the NAAQS in another state. The two provisions of this section are referred to as prong 1 (significant contribution to nonattainment) and prong 2 (interference with maintenance). Section 110(a)(2)(D)(i)(II) requires SIPs to contain adequate provisions to prohibit emissions that will interfere with measures required to be included in the applicable implementation plan for any other state under part C to prevent significant deterioration of air quality (prong 3) or to protect visibility (prong 4).

On August 15, 2018, the Georgia Environmental Protection Division provided a SIP submittal to EPA to address the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS, containing a certification that the State's SIP meets the requirements of prongs 1 and 2. Georgia's certification is based on available emissions data, air quality monitoring and modeling data, SIP-approved  1 provisions regulating emissions of ozone precursors within the State, and an analysis of recent trends in emissions of ozone precursors (VOCs and NO X ) from Georgia sources.

In a notice of proposed rulemaking (NPRM) published on July 11, 2019 (84 FR 33027), EPA proposed to determine that Georgia will not contribute significantly to nonattainment or interfere with maintenance of the 2008 8-hour ozone NAAQS in any other state and to approve Georgia's August 15, 2018, SIP submission as meeting the CAA requirements of prongs 1 and 2 under section 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS. 2 In that notice, EPA discussed the final determination made in the update to the Cross-State Air Pollution Rule ozone season program, which addresses good neighbor obligations for the 2008 8-hour ozone NAAQS (known at the “CSAPR Update”), 3 that emissions activities within Georgia will not significantly contribute to nonattainment or interfere with maintenance of that NAAQS in any other state. The NPRM provides additional detail regarding the background and rationale for EPA's action. Comments on the NPRM were due on or before August 12, 2019. EPA received no comments on the NPRM.

EPA is taking final action to determine that Georgia will not contribute significantly to nonattainment or interfere with maintenance of the 2008 8-hour ozone NAAQS in any other state. Therefore, EPA is finalizing approval of Georgia's August 15, 2018, SIP submission as meeting the CAA requirements of prongs 1 and 2 under section 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS. EPA is taking final action to approve the SIP submission because it is consistent with section 110 of 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 that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

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

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

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

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.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 25, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

On July 10, 2019 (84 FR 32841), the EPA published a final rule entitled “Designation of Areas for Air Quality Planning Purposes; California; Coachella Valley 8-Hour Ozone Nonattainment Area; Reclassification to Extreme” that granted a request from the State of California to reclassify the Coachella Valley nonattainment area from “Severe-15” to “Extreme” for the 1997 ozone national ambient air quality standards. That publication incorrectly identified the docket number, which could make it difficult for members of the public to locate documents related to the reclassification. This document corrects the docket number in that rule.

In FR Doc. 2019-14612, published July 10, 2019 (84 FR 32841), make the following corrections:

1. On page 32841, in the third column, correct the docket number for “Designation of Areas for Air Quality Planning Purposes; California; Coachella Valley 8-Hour Ozone Nonattainment Area; Reclassification to Extreme” to read: “[EPA-OAR-R09-2019-0240; FRL-9996-12-Region 9]”

2. On page 32842, in the first column, correct the first sentence of the ADDRESSES caption to read:

“The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2019-0240”.

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2018-0194 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before November 25, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2018-0194, by one of the following methods:

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

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

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

In the Federal Register of Tuesday, July 24, 2018 (83 FR 34968) (FRL-9980-31), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F8651) by ISK Biosciences Corporation, 7470 Auburn Rd, Suite A, Concord, OH 44077. The petition requested that 40 CFR 180.694 be amended by establishing tolerances for residues of the insecticide cyclaniliprole, 3-bromo-N-[2-bromo-4-chloro-6-[[(1-cyclopropylethyl)amino]carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on the following commodities: Citrus fruit (crop group 10-10) at 0.5 parts per million (ppm); tuberous & corm vegetables (crop group 1C) at 0.01 ppm; and berry & small fruit (crop subgroup 13-07A, 13-07B, 13-07E except grape, and 13-07G) at 1.5 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from the levels requested as allowed by section 408(d)(4)(A)(i) of FFDCA. The reason for these changes are explained in Unit IV.D.

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

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

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

No single or repeated dose study performed by any route of exposure produced an adverse effect following cyclaniliprole exposure at dose levels below, at, or above the limit dose (1,000 milligrams/kilogram/day (mg/kg/day)). Although the oral toxicity studies in dogs were conducted at approximately a third of the limit dose, no adverse effects were seen. It is unlikely that cyclaniliprole would produce adverse liver effects, if tested at higher doses in dogs as a structurally related chemical, chlorantraniliprole, was tested up to the limit dose in dogs and did not demonstrate liver effects. There is no evidence that cyclaniliprole produces increased susceptibility with prenatal or postnatal exposures. Cyclaniliprole is considered not likely to be carcinogenic based on no increase in treatment-related tumor incidence in carcinogenicity studies in rats and mice and no genotoxicity.

Specific information on the studies received for cyclaniliprole as well as the no-observed-adverse-effect-level (NOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Cyclaniliprole: Human Health Risk Assessment for the Proposed New Uses on Bushberry Subgroup 13-07B; Caneberry Subgroup 13-07A; Citrus Fruit Crop Group 10-10; Low Growing Berry Subgroup 13-07G; Small Fruit Vine Climbing (except Grape) Subgroup 13-07E; and Tuberous and Corm Vegetables Crop Subgroup 1C.”, dated October 17, 2018 in docket ID number EPA-HQ-OPP-2018-0194.

Based on the review of the available cyclaniliprole toxicological studies, no toxicity endpoints or points of departure were selected for risk assessment. Based on the toxicological profile of cyclaniliprole, EPA has concluded that the FFDCA requirements to retain an additional safety factor for protection of infants and children and to consider cumulative effects do not apply. Section 408(b)(2)(C) requires an additional tenfold margin of safety in the case of threshold risks, which cyclaniliprole does not present. Section 408(b)(2)(D)(v) requires consideration of information concerning cumulative effects of substances that have a common mechanism of toxicity, which cyclaniliprole does not have.

There is a potential for exposure to cyclaniliprole residues via food and drinking water based on existing uses and the proposed uses for cyclaniliprole application directly to growing crops. These applications can also result in cyclaniliprole reaching surface and ground water, both of which can serve as sources of drinking water. Moreover, there are no proposed uses in residential settings; therefore, there are no anticipated residential exposures.

Determination of safety. Based on the available data indicating a lack of adverse effects from exposure to cyclaniliprole, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to cyclaniliprole.

Adequate enforcement methods have been proposed for plants (Method JSM0269) and livestock commodities (Method JSM0277). For plants and livestock, cyclaniliprole residues are extracted using acetonitrile, cleaned up and analyzed by liquid chromatography with tandem mass spectrometry (LC-MS/MS). The validated limit of quantitation (LOQ) was 0.01 ppm for plants and livestock commodities. All concurrent recoveries of cyclaniliprole at the fortification level of 0.01 ppm in the field trials and processing studies were within the acceptable range of 70-120%. The method is considered suitable for enforcement purposes. Adequate independent laboratory validation (ILV) and adequate radio-validation studies were conducted for the methods.

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

The Codex has not established MRLs for cyclaniliprole.

Tolerances were requested for citrus fruit (crop group 10-10) at 0.5 ppm; tuberous & corm vegetables (crop group 1C) at 0.01 ppm; and berry & small fruit (crop subgroup 13-07A, 13-07B, 13-07E except grape, and 13-07G) at 1.5 ppm.

EPA considered commodity definitions and additional information provided by ISK Biosciences Corporation, including field trial residues that were adjusted by proportionality to reflect the proposed used pattern and used the Organization for Economic Cooperation and Development (OECD) statistical calculation procedures to determine the appropriate tolerance value which resulted in a different tolerance value for each of these subgroups than what the petitioner requested.

EPA is establishing separate subgroup tolerances for fruit, citrus, group 10-10, in anticipation of the establishment of subgroup MRLs by Codex, rather than a single group MRL. For citrus fruit crop group 10-10, EPA is establishing tolerances for orange subgroup 10-10A at 0.4 ppm, lemon/lime subgroup 10-10B at 0.3 ppm, and grapefruit subgroup 10-10C at 0.2 ppm. Based on processing studies, EPA is further establishing tolerances for fruit, citrus, group 10-10, oil at 30 ppm in accordance with its regulatory requirement to establish tolerances for processed commodities made necessary by the use of the pesticide on the commodities in the underlying crop group.

For tuberous & corm vegetables (crop group 1C), EPA is establishing the tolerance at 0.01 ppm. Based on processing information and in accordance with 40 CFR 180.40(f), EPA is further establishing a tolerance for potato (wet peel) at 0.06 ppm.

For the berries, the registrant proposed tolerances as berry and small fruit (Crop Subgroups 13-07A, 13-07B, 13-07E (except grape), and 13-07G at 1.5 ppm. HED is recommending for individual crop subgroup tolerances, with the tolerance level based on the representative commodities for the specific subgroups. For the berry and small fruit subgroups, EPA is establishing the tolerance for caneberry subgroup 13-07A at 0.8 ppm; bushberry subgroup 13-07B at 1.5 ppm; fruit, small vine climbing (except grape) subgroup 13-07E at 1 ppm; and berry, low growing, subgroup 13-07G at 0.4 ppm.

Although the lack of toxicity supports a safety finding for an exemption from the requirement of tolerance for all crops, EPA is establishing tolerances for residues resulting from direct applications to certain commodities because the petitioner requested them for international trade purposes. Tolerances are established for residues of cyclaniliprole, 3-bromo-N-[2-bromo-4-chloro-6-[[(1- cyclopropylethyl)amino]carbonyl] phenyl]-1-(3-chloro-2-pyridinyl)-1Hpyrazole-5-carboxamide in or on orange subgroup 10-10A at 0.4 ppm; lemon/lime subgroup 10-10B at 0.3 ppm; grapefruit subgroup 10-10C at 0.2 ppm; and fruit, citrus, group 10-10, oil at 30 ppm; vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; and potato, wet peel at 0.06 ppm; caneberry subgroup 13-07A at 0.8 ppm; bushberry subgroup 13-07B at 1.5 ppm; fruit, small, vine climbing, except grape, subgroup 13-07E at 1 ppm; and berry, low growing, subgroup 13-07G at 0.4 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2018-0645 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before November 25, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2018-0645, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of December 21, 2018 (83 FR 65660) (FRL-9985-67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 8F8675) by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of florpyrauxifen-benzyl. That document referenced a summary of the petition prepared by the petitioner, Dow AgroSciences, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by florpyrauxifen-benzyl are discussed in this unit.

Florpyrauxifen-benzyl is not genotoxic and there were no treatment related findings up to the limit dose (1,000 milligrams/kilogram (mg/kg)/day) or highest doses tested in the acute, short-term, sub-chronic, or chronic oral toxicity studies, 2-generation reproduction or developmental toxicity studies or in the neurotoxicity study.

Chronic administration of florpyrauxifen-benzyl did not show any carcinogenicity potential and did not cause any adverse effects in mice, rats or dogs even up to the highest doses tested. Given the absence of adverse effects or toxicity in the database, the Agency did not establish any toxicity endpoints or points of departure for conducting a quantitative risk assessment. In a qualitative assessment of risk, the Agency does not use uncertainty factors, which means that the safety factor required section 408(b)(2)(C) of FFDCA in the case of threshold effects for the protection of infants and children is not applicable. The Agency has determined that there are no residual uncertainties in the toxicity or exposure databases, and there is no evidence of increased susceptibility of infants or children from exposure to florpyrauxifen-benzyl. Based on its review of the available data, the Agency concludes that a qualitative assessment without uncertainty or safety factors would be safe for infants and children.

Specific information on the studies received and the nature of the adverse effects caused by florpyrauxifen-benzyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Florpyrauxifen-benzyl: New Active Ingredient, First Food Use. Human Health Risk Assessment for the Establishment of Permanent Tolerances on Rice, Fish, and Shellfish and Registration for Uses on Rice and Freshwater Aquatic Weed Control” in docket ID number EPA-HQ-OPP-2018-0645.

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

There is potential for exposure to florpyrauxifen-benzyl via food and drinking water based on the proposed and approved uses. In addition, there is a potential for non-occupational, non-dietary exposure to swimmers in waters treated with florpyrauxifen-benzyl. But because no adverse effects were observed in the submitted toxicological studies for florpyrauxifen-benzyl regardless of the route of exposure, a qualitative assessment of risk is appropriate for this compound.

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

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

Based on the information in this preamble and the supporting documentation, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to florpyrauxifen-benzyl residues. Accordingly, EPA finds that exempting florpyrauxifen-benzyl residues from the requirement of a tolerance when applied or used as an herbicide in accordance with good agricultural practices will be safe.

An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation because of the lack of toxicity concern about the presence of residues.

Therefore, an exemption is established for residues of florpyrauxifen-benzyl, including its metabolites and degradates, in or on all food commodities, when it is applied as an herbicide according to good agricultural practices. In addition, although not requested in the petition, EPA is removing from the Title 40 of the Code of Federal Regulations section 180.695 and the established tolerances on fish—freshwater finfish; fish—shellfish, crustacean; fish—shellfish, mollusc; and rice, grain. The residues on those commodities are subsumed within the new exemption, so the existing numerical tolerances are redundant and no longer necessary.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

On February 19, 2019, Ohio submitted a complete program revision application seeking authorization of changes to its hazardous waste program in accordance with 40 CFR 271.21. EPA now makes a final decision that Ohio's hazardous waste program revisions that are being authorized are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all of the requirements necessary to qualify for final authorization. For a list of State rules being authorized with this final authorization, please see the proposed rule published in the June 11, 2019 Federal Register at 84 FR 27057.

Codification is the process of placing citations and references to the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. EPA does this by adding those citations and references to the authorized State rules in 40 CFR part 272. EPA is not codifying the authorization of Ohio's revisions at this time. However, EPA reserves the ability to amend 40 CFR part 272, subpart KK, for the authorization of Ohio's program changes at a later date.

This final authorization revises Ohio's authorized hazardous waste management program pursuant to Section 3006 of RCRA and imposes no requirements other than those currently imposed by State law. For further information on how this authorization complies with applicable executive orders and statutory provisions, please see the proposed rule published in the June 11, 2019, Federal Register at 84 FR 27057. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This final action will be effective September 26, 2019.

This is a summary of the Public Notice ( 833 Auction Procedures Public Notice ), AU Docket No. 19-101; WC Docket No. 17-192; CC Docket No. 95-155, FCC 19-75, adopted on August 1, 2019 and released on August 2, 2019. The complete text of the 833 Auction Procedures Public Notice is available for public inspection and copying from 8:00 a.m. to 4:30 p.m. Eastern Time (ET) Monday through Thursday or from 8:00 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, 445 12th Street SW, Room CY-A257, Washington, DC 20554. The complete text is also available on the Commission's website at https://www.fcc.gov/wireline-competition/competition-policy-division/numbering-resources/833-toll-free-number-auction or by using the search function for AU Docket No. 19-101, WC Docket No. 17-192, or CC Docket No. 95-155 on the Commission's ECFS web page at www.fcc.gov/ecfs/. Alternative formats are available to persons with disabilities by sending an email to FCC504@fcc.gov or by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. With the 833 Auction Procedures Public Notice, the Commission establishes procedures for the upcoming auction of certain toll free numbers in the 833 code (833 Auction). The 833 Auction, which will serve as an experiment in using competitive bidding as a way to assign toll free numbers, will make available 17,638 numbers in the 833 code. Bidding in the 833 Auction will occur on December 17, 2019. The 833 Auction Procedures Public Notice provides details regarding the procedures, terms, and conditions, as well as dates and deadlines, governing participation in the 833 Auction, and an overview of post-auction payments and requirements, including disclosure requirements for post-auction secondary market transactions.

2. In 2018, the Commission modified its toll free assignment rule in the Toll Free Assignment Modernization Order, 83 FR 53377, October 23, 2018, to provide greater flexibility and permit alternative approaches to assigning numbers. Specifically, the Commission added competitive bidding as a method to assign toll free numbers and, as an experiment in using this approach, established the 833 Auction to assign numbers that were requested by two or more Responsible Organizations (“RespOrgs”) during the 833 pre-code opening process.

3. The Commission set out the general framework for the 833 Auction in the Toll Free Assignment Modernization Order and designated Somos, Inc., the Toll Free Numbering Administrator, as the auctioneer. The Commission opened participation in the 833 Auction to not only RespOrgs but also potential subscribers who may wish to participate directly. The Commission also called for a pre-bidding process during which it would seek comment on detailed auction procedures, as is typical in Commission auctions.

4. In May 2019, the Commission initiated the pre-bidding process by releasing a public notice seeking comment on auction procedures to be used in the 833 Auction. Seven parties submitted filings in response to the 833 Auction Comment Public Notice, 84 FR 24424, May 28, 2019.

5. Section 251(e)(1) of the Communications Act of 1934, as amended (the Act), empowers the Commission to ensure that toll free numbers are allocated in an equitable and orderly manner that serves the public interest. Pursuant to this statutory mandate, the Commission has the authority to set policy with respect to all facets of numbering administration in the United States, and must do so in an efficient, fair, and orderly manner. As in the Toll Free Assignment Modernization Order, the actions the Commission takes in the 833 Auction Procedures Public Notice are designed to meet the statutory requirement that numbers be made “available on an equitable basis,” by establishing auction and secondary market procedures that are efficient, orderly, and fair.

6. In addition to the Toll Free Assignment Modernization Order, other Commission decisions and rules provide additional information useful to any party interested in participating in the 833 Auction. For example, many of the application and bidding requirements set forth in the 833 Auction Procedures Public Notice are based on the Commission's general competitive bidding rules. Thus, prospective applicants should familiarize themselves with those rules, including recent amendments and clarifications, as well as Commission decisions in proceedings regarding competitive bidding procedures and application requirements.

7. Moreover, as part of their due diligence responsibilities, applicants must be thoroughly familiar with the procedures, terms, and conditions contained in 833 Auction Procedures Public Notice and any future public notices that may be released in the 833 Auction proceeding (AU Docket No. 19-101, WC Docket No. 17-192, CC Docket No. 95-155). The terms contained in the Commission's rules, relevant orders, and public notices are not negotiable. The Commission may amend or supplement the information contained in its public notices at any time and will issue public notices to convey new or supplemental information to applicants. It is the responsibility of all applicants to remain current with all Commission rules and with all public notices pertaining to the 833 Auction. Copies of most auctions-related Commission documents, including public notices, can be retrieved at www.fcc.gov/auctions, and copies of documents related to the 833 Auction can be retrieved at https://www.fcc.gov/wireline-competition/competition-policy-division/numbering-resources/833-auction. Additionally, documents are available through Somos at http://auction.somos.com/ and at the Commission's headquarters, located at 445 12th Street SW, Washington, DC 20554, during normal business hours.

8. In the 833 pre-code opening process, the Commission's Wireline Competition Bureau authorized RespOrgs to identify up to 2,000 desired numbers in the 833 code and submit a request for those numbers to Somos. Somos identified 17,638 toll free numbers as requested by two or more RespOrgs and placed those numbers in unavailable status. In the Toll Free Assignment Modernization Order, the Commission announced that the rights to use these 17,638 toll free numbers in the 833 code would be offered in the 833 Auction.

9. The Commission, in the Toll Free Assignment Modernization Order, provided one exception to making these numbers available in the 833 Auction by allowing government entities and non-profit health and safety organizations to file petitions to set aside numbers from the auction for use for public health and safety purposes. On April 16, 2019, the Wireline Competition Bureau released a Public Notice seeking petitions to set aside toll free numbers pursuant to this exception. No petitions were submitted. Consequently, all 17,638 numbers previously identified as having multiple requests will be offered in the 833 Auction. 833 Auction applicants must select the toll free numbers (from the available list) for which they may bid on their auction applications. If a particular available toll free number is not selected on any auction application, it will not be available in the auction. A complete list of these 17,638 numbers is available in electronic format only at http://auction.somos.com/.

10. In the Toll Free Assignment Modernization Order, the Commission designated Somos as the auctioneer for the 833 Auction. As such, Somos will be required to implement the procedures established in the 833 Auction Procedures Public Notice to conduct the auction, including: Accepting applications to participate in the bidding (auction applications); reviewing the applications for sufficiency; accepting upfront payments; announcing which applicants are qualified to bid (qualified bidders); accepting and processing the bids; announcing the winning bidders; and accepting final payments. To accomplish these tasks, Somos must provide an online system(s) for the 833 Auction that will accept auction applications and bids (collectively Somos Auction System) and Somos must provide procedures to accept both upfront and final payments.

11. The following dates and deadlines apply to the 833 Auction:

12. Those wishing to participate in the 833 Auction must:

• Register for an Auction ID online through the Somos Auction System;

• Submit an auction application (FCC Form 833) electronically through the Somos Auction System prior to 6:00 p.m. ET on October 18, 2019, following filing procedures set forth in the 833 Auction Procedures Public Notice and any FCC Form 833 instructions provided by Somos;

• Submit a sufficient upfront payment to Somos by 6:00 p.m. ET on November 27, 2019, following the procedures set forth in the 833 Auction Procedures Public Notice; and

• Comply with all provisions outlined in the 833 Auction Procedures Public Notice and applicable Commission rules and orders.

13. In the Toll Free Assignment Modernization Order, the Commission established certain principles to promote the transparency and efficiency of the 833 Auction, and reduce the potential for conflicts of interest and anticompetitive strategic behavior by participants. The Commission sought comment in the 833 Auction Comment Public Notice on specific procedures to implement these principles, and in the 833 Auction Procedures Public Notice, the Commission describes how these principles will be implemented for the 833 Auction.

14. The Commission adopts the proposal in the 833 Auction Comment Public Notice to allow a potential subscriber to participate in the 833 Auction either (1) through a RespOrg that will bid on all the numbers in which the subscriber is interested in acquiring, or (2) by submitting its own application and bidding for all the numbers in which it is interested. Thus, a potential subscriber cannot selectively choose to be represented by a RespOrg to bid on its behalf for some numbers and submit an application on its own to bid for other numbers.

15. In the Toll Free Assignment Modernization Order, the Commission required that potential subscribers participate in the 833 Auction through only a single auction applicant. In the 833 Auction Comment Public Notice, the Commission proposed to implement this principle by requiring that a potential subscriber may participate either through a RespOrg that will bid on all the numbers that the subscriber is interested in acquiring, or by submitting its own application and bidding for all of the numbers in which it is interested. The Commission received one comment on this issue. CenturyLink agrees with the Commission's proposal, asserting that this “bright line on participation” will help parties clarify their roles and promote the integrity of the auction process. The Commission agrees with CenturyLink's assessment and also believes the proposed application procedure is consistent with the requirement that a potential subscriber may participate through only a single auction applicant, which is necessary to implement the prohibition on certain communications, and with the decision to prohibit certain agreements among auction applicants. Thus, the Commission adopts the application procedure as proposed. If a potential subscriber is represented on applications submitted by multiple RespOrgs, or files its own application and is also represented on a RespOrg application, only one of the applications on which it is represented may become qualified to bid ( i.e., any additional subscriber application(s) will be dismissed and/or any additional RespOrg applications will not be found qualified to bid for the potential subscriber's selected toll free number(s)).

16. In the 833 Auction Comment Public Notice, the Commission proposed two certifications in the auction application related to the single applicant/application mandate. First, it proposed that the auction application require that each applicant certify that (i) if it is bidding on its own behalf, it is also not participating in the auction through another entity, and/or (ii) if it is bidding on behalf of potential subscriber(s), it is not aware that the potential subscriber(s) are participating through another applicant. Second, the Commission proposed requiring each applicant to certify that it, or any commonly-controlled entity, is not submitting multiple applications in the 833 Auction. The Commission received no comments on the proposed certifications, and concludes that the certifications should aid in enforcing the single applicant/application mandate. Thus, every applicant must certify in its auction application that: (1) It is not participating in the auction through another entity; (2) it is not aware that any entity on whose behalf it is bidding is participating through another applicant; and (3) it, or any commonly-controlled entity, is not submitting multiple applications in the 833 Auction. This language clarifies language proposed in the 833 Auction Comment Public Notice in order to emphasize that the requirement to bid only through a single applicant applies to every applicant, regardless of whether it is bidding on its own behalf, or on behalf of another entity. Moreover, by “commonly-controlled entity,” the Commission means an entity that controls or is controlled by another party.

17. To identify commonly controlled entities in the 833 Auction, the 833 Auction Comment Public Notice proposed to define a “controlling interest” as an individual or entity with positive or negative de jure or de facto control of the applicant. As noted in the 833 Auction Comment Public Notice, the Commission's part 1 rules state that de jure control includes holding 50 percent or more of the voting stock of a corporation or holding a general partnership interest in a partnership. Ownership interests that are held indirectly by any party through one or more intervening corporations may be determined by successive multiplication of the ownership percentages for each link in the vertical ownership chain and application of the relevant attribution benchmark to the resulting product, except that if the ownership percentage for an interest in any link in the chain meets or exceeds 50 percent or represents actual control, it may be treated as if it were a 100 percent interest. De facto control is determined on a case-by-case basis. Examples of de facto control include constituting or appointing 50 percent or more of the board of directors or management committee; having authority to appoint, promote, demote, and fire senior executives that control the day-to-day activities of the entity; or playing an integral role in management decisions.

18. The 833 Auction Comment Public Notice also sought comment on a presumption of control by spouses and immediate family members. In this context “immediate family member” would mean father, mother, husband, wife, son, daughter, brother, sister, father- or mother-in-law, son- or daughter-in-law, brother- or sister-in-law, step-father or -mother, step-brother or -sister, step-son or -daughter, half brother or sister. The Commission proposed to place the burden on applicants to sufficiently demonstrate that spouses or family members should not be treated as having an identity of interest such that it creates common control, and that where the presumption has not been adequately rebutted, such spouses and family members will be subject to the prohibition on submission of multiple auction applications by commonly controlled entities.

19. One commenter, 1-800 Contacts, opposes the Commission's proposal for defining the controlling interests of auction applicants, arguing that many toll free number subscribers are commonly owned “through large investment funds or corporate conglomerates,” but “have no day-to-day involvement with each other” and therefore, should be allowed to bid separately without having to develop a coordinated bidding strategy. 1-800 Contacts advocates a more lenient approach to controlling interests that would allow commonly owned (but not commonly controlled) entities to participate separately in the auction, specifically suggesting limiting control to “de jure control combined with actual day-to-day involvement in the operational activities of the company.”

20. In the Toll Free Assignment Modernization Order, the Commission stated that, while it would seek comment and decide how to define parties with common controlling interests in the pre-auction process, it anticipated using the Commission's definitions adopted for similar purposes in its spectrum auctions ( e.g., § 1.2105(a)(4)(i) of the Commission's rules). The Commission is unconvinced by the arguments of 1-800 Contacts, and it adopts the controlling interest standard as proposed in the 833 Auction Comment Public Notice — i.e., an individual or entity with positive or negative de jure or de facto control. Because entities that have control (either legal control or actual control) can behave in a coordinated fashion, entities with common controlling interests should not be able to participate through separate entities in the auction. Moreover, such an approach is simpler and is consistent with the Commission's approach for its spectrum auctions. As 1-800 Contacts itself notes, requiring a determination of actual day-to-day involvement (in addition to de jure control) would be subjective and may be difficult for other auction participants and Somos to definitively make. Further, unlike 1-800 Contacts, the Commission believes that the experimental nature of this auction supports consistency with the same standard that it uses in Commission auctions. If it uses the same standard applied in Commission auctions, participants in the 833 Auction can rely on any prior experience in Commission auctions and on Commission precedent for guidance. Thus, the Commission concludes that the controlling interest standard as proposed in the 833 Auction Comment Public Notice is preferable and therefore adopts the proposal.

21. The Commission received no comments on the presumption of control by spouses and immediate family members proposed in the 833 Auction Comment Public Notice. Therefore, it adopts the presumptions (and definitions) set forth therein, and notes that if an applicant wishes to rebut a presumption of control by a spouse or family member, it should do so in a narrative explanation to its auction application.

22. Additionally, the Commission reiterates that any 833 Auction applicants that have overlapping non-controlling interests must take steps to prevent communicating bid information with each other. Specifically, applicants with overlapping non-controlling interests must certify they have established internal controls to preclude any person acting on behalf of an applicant from possessing information about the bids or bidding strategies of more than one applicant or communicating such information to another person acting on behalf of and possessing such information regarding another applicant. The Commission will include such a certification in the auction application.

23. Each applicant in the 833 Auction is prohibited from cooperating or collaborating with any other applicant with respect to its own, or one another's, or any other competing applicant's bids or bidding strategies. Each applicant will be prohibited from communicating, with any other applicant in any manner, the substance of its own, or one another's, or any other competing applicant's bids or bidding strategies (including with respect to the post-auction market for toll free numbers). The Commission proposed this prohibition in the 833 Auction Comment Public Notice to reinforce existing antitrust laws, facilitate detection of collusive conduct, and deter anticompetitive behavior. The Commission received no comments on this proposal and therefore, for the reasons stated in proposing it, the Commission adopts the prohibition on certain communications for the 833 Auction.

24. For purposes of the prohibition on certain communications, an “applicant” in the 833 Auction includes: (i) All controlling interests in the entity submitting the auction application; (ii) all holders of partnership and other ownership interests and any stock interest amounting to 10 percent or more of the entity, or outstanding stock, or outstanding voting stock of the entity submitting the auction application; (iii) all officers and directors of that entity; and (iv) any entity listed as a potential subscriber on whose behalf the entity submitting the auction application will be bidding. As in the Commission's spectrum auctions, in the case of a consortium, each member of the consortium shall be considered to have a controlling interest in the consortium. The Commission proposed in the 833 Auction Comment Public Notice to define “applicant” broadly for the purposes of the prohibition on certain communications, consistent with its spectrum license and universal service support auctions. One commenter, 1-800 Contacts, supports the proposal, stating that applying the prohibition broadly “will help ensure the integrity of the auction process.” The Commission agrees with this assessment and adopts the definition of applicant for purposes of the prohibition as proposed.

25. The prohibition on certain communications for the 833 Auction will begin at the deadline for submitting auction applications ( i.e., 6:00 p.m. on October 18, 2019) and will end at the deadline for winning bidders to submit their final payments with a late fee ( i.e., 15 business days after the winning bidders are announced).

26. In the 833 Auction Comment Public Notice, the Commission stated that the prohibition on certain communications will begin at the auction application deadline and will end “at the post-auction deadline for winning bidders to submit their final payments (which will be announced by Somos after bidding concludes).” The Commission clarifies that, for “final payment deadline,” it will use the deadline for winning bidders to submit their final payments with a late fee. In the Commission's spectrum auctions, the prohibition on certain communications runs until the down payment deadline, and in its auctions for universal service support, the prohibition runs until the post-auction deadline for winning bidders to submit applications for support. For the 833 Auction, because winning bidders have neither a down payment nor a post-auction application requirement, the most analogous point is the final payment. However, the final payment in this auction can be made up to an additional five business days after the final payment deadline so long as it is submitted with a late fee. Since the rationale to extend the prohibited communications period until after bidding applies equally during the period in which an applicant can submit the final payment with a late fee, the Commission clarifies that the prohibition will run until that last deadline ( i.e., 15 business days after Somos announces the winning bidders).

27. As proposed in the 833 Auction Comment Public Notice, an applicant will be prohibited from communicating, with any other applicant in any manner, the substance of its own, or one another's, or any other competing applicant's bids or bidding strategies (including with respect to the post-auction market for toll free numbers). In addition to express statements of bids and bidding strategies, the prohibition against communicating “in any manner” includes public disclosures as well as private communications and indirect or implicit communications. Consequently, an applicant must take care to determine whether its auction-related communications may reach another applicant. The Commission reminds applicants that they must determine whether their communications with other parties are permissible once the prohibition begins at the deadline for submitting auction applications, even before the public notice identifying applicants is released.

28. Applicants should take special care in circumstances where their officers, directors, and employees may receive information directly or indirectly relating to any applicant's bids or bidding strategies. Such information may be deemed to have been received by the applicant under certain circumstances. For example, Commission staff have found that where an individual serves as an officer and director for two or more applicants, the bids and bidding strategies of one applicant are presumed conveyed to the other applicant through the shared officer, which creates an apparent violation of the rule.

29. As noted in the 833 Auction Comment Public Notice, the prohibition will not apply to all communications between or among applicants; it will apply only to any communications conveying, in whole or part, directly or indirectly, the applicant's or a competing applicant's bids or bidding strategy (including with respect to the post-auction market for toll free numbers). Thus, communications, including business discussions and negotiations, unrelated to the toll free numbers being offered in the 833 Auction and that do not convey information about the numbers being auctioned or bidding strategies are not prohibited. Moreover, not all auction-related information is necessarily covered by the prohibition. For example, communicating merely whether a party has or has not applied to participate in the 833 Auction should not violate the prohibition. In contrast, communicating how a party will participate, including specific numbers or bid amounts, and/or whether or not a party will place bids, would convey bid or bidding strategies and therefore is prohibited.

30. Although the restriction does not prohibit business discussions and negotiations among auction applicants that are not auction related, each applicant must remain vigilant not to communicate, directly or indirectly, information that affects, or could affect, bids or bidding strategies. Certain discussions might touch upon subject matters that could convey price or geographic information related to bidding strategies. Such subject areas include, but are not limited to, management, sales, local marketing agreements, and other transactional agreements.

31. The Commission also cautions applicants that bids or bidding strategies may be communicated outside of situations that involve one party subject to the prohibition communicating privately and directly with another such party. For example, the Commission has warned that prohibited “communications concerning bids and bidding strategies may include communications regarding capital calls or requests for additional funds in support of bids or bidding strategies to the extent such communications convey information concerning the bids and bidding strategies directly or indirectly.” Moreover, the Commission previously found a violation of the rule against prohibited communications when an applicant used the Commission's bidding system to disclose “its bidding strategy in a manner that explicitly invited other auction participants to cooperate and collaborate . . . in specific markets” and has placed auction participants on notice that the use of its bidding system “to disclose market information to competitors will not be tolerated and will subject bidders to sanctions.”

32. Likewise, when completing an auction application, each applicant should avoid any statements or disclosures that may violate the prohibition on certain communications, particularly in light of the limited information procedures in effect for the 833 Auction. Specifically, an applicant should avoid including any information in its auction application that might convey information regarding its toll free number selections, as applicable, such as referring to certain toll free numbers in describing agreements, including any information in application attachments that will be publicly available that may otherwise disclose the applicant's toll free number selections, or using applicant names that refer to numbers being offered.

33. Applicants also should be mindful that communicating non-public application or bidding information publicly or privately to another applicant may violate the prohibition on certain communications even though that information subsequently may be made public during later periods of the application or bidding processes.

34. The 833 Auction's prohibition on certain communications does not prohibit an applicant from communicating bids or bidding strategies to a third-party, such as a consultant or consulting firm, counsel, or lender. The applicant should take appropriate steps, however, to ensure that any third party it employs for advice pertaining to its bids or bidding strategies does not become a conduit for prohibited communications to other specified parties, as that would violate the prohibition. For example, an applicant might require a third party, such as a lender, to sign a non-disclosure agreement before the applicant communicates any information regarding bids or bidding strategy to the third party. Within third-party firms, separate individual employees, such as attorneys or auction consultants, may advise individual applicants on bids or bidding strategies, as long as such firms implement firewalls and other compliance procedures that prevent such individuals from communicating the bids or bidding strategies of one applicant to other individuals representing separate applicants. Although firewalls and/or other procedures should be used, their existence is not an absolute defense to liability if a violation has occurred.

35. As Commission staff have explained in the context of the Broadcast Incentive Auction, in the case of an individual, the objective precautionary measure of a firewall is not available. As a result, an individual that is privy to bids or bidding information of more than one applicant presents a greater risk of becoming a conduit for a prohibited communication. The Commission will take the same approach to interpreting the prohibited communications rule in the 833 Auction. Moreover, the Commission emphasizes that whether a prohibited communication has taken place in a given case will depend on all the facts pertaining to the case, including who possessed what information, what information was conveyed to whom, and the course of bidding in the auction.

36. For purposes of the 833 Auction, the Commission prohibits separate applicants from designating the same individual on their auction applications to serve as an authorized bidder. This prevents a single individual with knowledge of the bidding strategies of more than one applicant from conveying (even unintentionally) advice to any of those applicants that is influenced by his or her knowledge about another applicant's bids or bidding strategies in violation of the prohibition on certain communications among auction applicants. A violation of the prohibition could also occur if the authorized bidders are different individuals employed by the same organization ( e.g., a law firm, engineering firm, or consulting firm). In the latter case, at a minimum, applicants should certify on their applications that precautionary steps have been taken to prevent communications between authorized bidders and that the applicant and its bidders will comply with the prohibition on certain communications.

37. The Commission reminds potential applicants that they may discuss the auction application or bids for specific toll free numbers with the counsel, consultant, or expert of their choice before the auction application deadline. Furthermore, the same third-party individual could continue to give advice regarding the application after the deadline, provided that no information pertaining to bids or bidding strategies, including toll free numbers selected on the auction application, is conveyed to that individual. To the extent potential applicants can develop bidding instructions prior to the application deadline that a third-party could implement without changes during bidding, the third-party could follow such instructions for multiple applicants provided that those applicants do not communicate with the third-party during the prohibition period.

38. Applicants also should use caution in their dealings with other parties, such as members of the press, financial analysts, or others who might become conduits for the communication of prohibited bidding information. For example, even though communicating that it has applied to participate in the auction will not violate the prohibition, an applicant's statement to the press of its intent not to place bids in the auction could give rise to a finding of a prohibited communications violation.

39. When submitting its auction application, each applicant for the 833 Auction must certify its compliance with the prohibition on certain communications. One commenter supports this certification. As in the Commission's spectrum and universal service support auctions, the mere filing of a certifying statement as part of an application will not outweigh specific evidence that a prohibited communication has occurred, nor will it preclude the initiation of an investigation when warranted. Any applicant found to have violated the prohibition on certain communications may be subject to sanctions, including among other things, forfeiture and a prohibition from participating further in the 833 Auction and in any future Commission auctions.

40. Any applicant that makes or receives a communication that appears to violate the prohibition on certain communications must report such communication in writing to the Commission and Somos staff immediately, and in no case later than five business days after the communication occurs. The Commission proposed this requirement in the 833 Auction Comment Public Notice and received no comments on the proposal. Each applicant's obligation to report any such communication continues beyond the five-day period after the communication is made, even if the report is not made within the five-day period.

41. A party reporting any information or communication that appears to violate the prohibition on certain communications must take care to ensure that any report does not itself violate the prohibition. To minimize the risk of inadvertent dissemination of information in such reports, parties reporting a potential prohibited communication must submit a report directly to the following individuals: (1) Margaret W. Wiener, Chief, Auctions Division, Office of Economics and Analytics, by email to 833auction@fcc.gov; and (2) Joel Bernstein, Vice President, Regulatory and Public Policy, Somos, by email to auctionhelp@somos.com.

42. Given the potential competitive sensitivity of public disclosure of information in such a report, a party seeking to report such a prohibited communication should consider submitting its report with a request that the report or portions of the submission be withheld from public inspection by following the procedures specified in § 0.459 of the Commission's rules. Such parties should use the contact information provided in the 833 Auction Procedures Public Notice to consult with Somos and Commission staff about the procedures for submitting such reports.

43. The Commission adopts its proposal in the 833 Auction Comment Public Notice to rely on past precedent and guidance regarding its rules on prohibited communications in connection with Commission spectrum auctions. The Commission received no comments on this proposal. A summary listing of documents addressing the application of § 1.2105(c) of the Commission's rules (the rule on prohibited communications for Commission spectrum auctions) is available on the Commission's auction web page at https://www.fcc.gov/summary-listing-documents-addressing-application-rule-prohibiting-certain-communications/.

44. Regardless of compliance with the Commission's rules, applicants remain subject to the antitrust laws, which are designed to prevent anticompetitive behavior in the marketplace. Compliance with the duty to report prohibited communications will not insulate a party from enforcement of the antitrust laws. For instance, a violation of the antitrust laws could arise out of actions taking place well before any party submits an auction application. The Commission has cited a number of examples of potentially anticompetitive actions that would be prohibited under antitrust laws: for example, actual or potential competitors may not agree to divide territories in order to minimize competition, regardless of whether they split a market in which they both do business, or whether they merely reserve one market for one and another market for the other.

45. To the extent the Commission becomes aware of specific allegations that suggest that violations of the Federal antitrust laws may have occurred, the Commission may refer such allegations to the United States Department of Justice for investigation. If an applicant is found to have violated the antitrust laws or the Commission's rules in connection with its participation in the competitive bidding process, it may be subject to a forfeiture and may be prohibited from participating further in the 833 Auction and in future auctions, among other sanctions.

46. To ensure the competitiveness of the 833 Auction, the Commission proposed certain restrictions on agreements related to the toll free numbers being auctioned. The 833 Auction Procedures Public Notice addresses the proposals raised in the 833 Auction Comment Public Notice to restrict agreements among auction applicants and agreements among RespOrgs and to disclose agreements between RespOrgs and potential subscribers.

47. The Commission adopts its proposal in the Auction 833 Comment Public Notice t o prohibit certain agreements among applicants in the 833 Auction (regardless of whether the applicants are RespOrgs or potential subscribers). The Commission received no comments on this proposal. The prohibition applies to any agreements, arrangements, or understandings of any kind to which the applicant (including any party that controls or is controlled by the applicant) is a party relating to the toll free numbers being auctioned that address or communicate directly or indirectly bids (including specific prices), bidding strategies (including the specific numbers on which to bid or not to bid), or the post-auction market for toll free numbers.

48. The Commission also adopts its proposal to define “applicant” for these purposes broadly to include: All controlling interests in the entity submitting the auction application; all holders of partnership and other ownership interests and any stock interest amounting to 10 percent or more of the entity, or outstanding stock, or outstanding voting stock of the entity submitting the auction application; all officers and directors of that entity; and any entity listed as a potential subscriber on whose behalf the entity submitting the auction application will be bidding. Although the definition of “applicant” for these purposes includes any entity listed as a potential subscriber on whose behalf the entity submitting the auction application will be bidding, the restriction does not prohibit the agreement necessary to provide authorization to the RespOrg applicant.

49. This prohibition will not apply to agreements unrelated to the toll free numbers being offered in the 833 Auction. Business discussions and negotiations that are unrelated to bidding in the 833 Auction and that do not convey information about the numbers being auctioned or bidding strategies are not prohibited, and thus, agreements reached by such communications unrelated to the toll free numbers being auctioned will not be prohibited.

50. The Commission prohibits auction-related agreements among RespOrgs even where only one of the RespOrgs is an applicant in the 833 Auction. The Commission received no comments on the restriction proposed in the 833 Auction Comment Public Notice. Given RespOrgs' position in the toll free number market, the Commission adopts its proposal to prohibit any applicant RespOrg from having an agreement related to the toll free numbers being offered in the 833 Auction with a non-applicant RespOrg. Thus, any RespOrg interested in acquiring the rights to any of the toll free numbers being auctioned must participate in the auction directly.

51. Similar to the prohibition on agreements among applicants, the prohibition among RespOrgs will not apply to agreements unrelated to the toll free numbers being offered in the 833 Auction. Because business discussions and negotiations that are unrelated to bidding in the 833 Auction and that do not convey information about the numbers being auctioned or bidding strategies are not prohibited, agreements reached by such communications unrelated to the toll free numbers being auctioned will not be prohibited.

52. In addition, the prohibition on agreements among RespOrgs would not apply to RespOrgs that are commonly controlled. Commonly-controlled entities are those in which the same individual or entity either directly or indirectly holds a controlling interest (as determined by positive or negative de jure or de facto control). When RespOrgs share a common officer or director or control, the Commission presumes that bids and bid strategies will be communicated. Moreover, the Commission reiterates, since commonly controlled RespOrgs cannot submit multiple applications, if they wish to apply for the 833 Auction, they will need to choose one of the entities to be the applicant and disclose the existence of the other commonly-controlled RespOrgs in the application.

53. Any applicant RespOrg that bids for a potential subscriber must acquire a letter of authorization from the potential subscriber. In the 833 Auction Comment Public Notice, the Commission recognized the unique position of RespOrgs, in that they can participate in the auction both on their own behalf and on behalf of other entities. Thus, the Commission believes that the relationship between an applicant RespOrg and a potential subscriber for which it is applying to bid should be formally authorized and transparent so that it can be easily verified. To that end, the Commission proposed to require any applicant RespOrg that bids for a potential subscriber to acquire a letter of authorization from the potential subscriber. No comments were received on the proposal. Based on the need to verify the relationship, the Commission will require a letter of authorization that clearly identifies the parties (both the potential subscriber and RespOrg) and toll free number(s) in which the RespOrg will bid for the potential subscriber. That letter must be dated and signed by the potential subscriber. Moreover, because an applicant RespOrg bidding on behalf of a potential subscriber is ultimately responsible for complying with all post-auction requirements, it is the responsibility of the applicant RespOrg to ensure the authorization by the potential subscriber is adequate ( e.g., has been signed by a person with authority to bind the entity).

54. The 833 Auction Comment Public Notice also sought comment on whether to require any applicant RespOrg bidding on behalf of a potential subscriber to provide the letter of authorization as part of its auction application ( e.g., by uploading it as an attachment) or to allow the applicant RespOrg to certify that it is in possession of the letter and be able to produce it to the Commission if requested. The Commission received no comments on either option. Since the upload process should not be burdensome and uploading the document should help Somos verify the relationship, the Commission will require any applicant RespOrg that is bidding on behalf of a potential subscriber to upload the letter of authorization as part of its auction application. The Commission directs Somos to withhold the public disclosure of these attachments until after the bidding, since the letters of authorization will contain specific information on toll free numbers being sought by the potential subscriber.

55. Consistent with the procedures in many recent Commission auctions, the Commission adopts its proposal that Somos conduct the 833 Auction using procedures for limited information disclosure (sometimes also referred to as anonymous bidding). The Commission received no comments on its proposal to use limited information procedures. Thus, the Commission directs Somos to withhold, until after the close of bidding and announcement of auction results, the public release of bidders' particular 833 number selections and any information that may reveal the identities of bidders placing bids and taking other bidding-related actions. More specifically, the following information will not be made public until after bidding has closed: (1) The numbers that an applicant selects for bidding in its auction application, (2) the amount of any upfront payment made by or on behalf of an applicant for the 833 Auction, (3) any applicant's bidding eligibility, and (4) any other bidding-related information that might reveal the identity of the bidder placing a bid or the amount of the bid.

56. Because the 833 Auction will be conducted using a single round of bidding, the Commission does not anticipate that there will be the same need for release of bidding-related actions during the auction that there would be in a multiple-round auction. If such circumstances were to arise prior to the release of non-public information and auction results, however, the Commission directs Somos to avoid releasing any information that may indicate the identity of any bidders taking such actions.

57. Moreover, after receiving no comments on the proposal in the 833 Auction Comment Public Notice to make public bidders' number selections, upfront payment amounts, bids, and any other bidding-related actions and information after the close of bidding, the Commission adopts the proposal. The Commission believes making this information available to the public, after bidding is complete, will increase auction transparency and allow the public generally to evaluate the experiment in using competitive bidding as a toll free number assignment method.

58. Any 833 Auction applicant, including a RespOrg participating on behalf of one or more potential subscribers, assumes a binding obligation to pay its full winning bid amount, and is responsible for complying with all post-auction requirements, regardless of whether a potential subscriber on whose behalf the RespOrg bid fulfills its financial or contractual obligation to the RespOrg. While an applicant RespOrg may seek reimbursement from the potential subscriber for which it bid, the RespOrg—as the bidder in the auction—is ultimately responsible for full payment of any winning bid.

59. Any party interested in obtaining an 833 number available through the auction must submit an application (FCC Form 833) to become qualified to bid in the 833 Auction. An application to participate in the 833 Auction, referred to in the 833 Auction Procedures Public Notice as an “auction application,” provides information that Somos, as the auctioneer, will use to determine whether the applicant is qualified to participate in the auction. Eligibility to participate in the 833 Auction is based on an applicant's auction application, including its certifications made under penalty of perjury, and on the applicant's submission of a sufficient upfront payment for the auction.

60. A party seeking to participate in the 833 Auction must file an FCC Form 833 electronically via the Somos Auction System prior to 6:00 p.m. ET on October 18, 2019, following the procedures prescribed in the 833 Auction Procedures Public Notice and any FCC Form 833 instructions provided by Somos. The 833 Auction Procedures Public Notice describes more fully the information disclosures and certifications required in the auction application. An applicant that files an application to participate in the 833 Auction will be subject to the prohibition on certain communications, beginning at the deadline for filing auction applications—6:00 p.m. ET on October 18, 2019. The prohibition will end for applicants on the post-auction final payment (with late fee) deadline. Each applicant remains subject to the prohibition until the end of the prohibition period, regardless of whether or not it becomes qualified to bid or actually submits any bids.

61. An applicant bears full responsibility for submitting an accurate, complete, and timely auction application. Each applicant must make a series of certifications under penalty of perjury on its FCC Form 833 related to the information provided in its application and its participation in the auction. If an applicant fails to make the required certifications in its FCC Form 833 by the filing deadline, its application will be deemed unacceptable for filing and cannot be corrected after the filing deadline.

62. An applicant should note that submitting an FCC Form 833 (and any amendments thereto) constitutes a representation by the certifying official that he or she is an authorized representative of the applicant with authority to bind the applicant, that he or she has read the form's instructions and certifications, and that the contents of the application, its certifications, and any attachments are true and correct. Submitting a false certification in an application may result in penalties, including monetary forfeitures, license forfeitures, ineligibility to participate in future auctions, and/or criminal prosecution.

63. Applicants are cautioned that because the required information submitted in an FCC Form 833 bears on each applicant's qualifications, requests for confidential treatment will not be routinely granted. The Commission has held generally that it may publicly release confidential business information where the party has put that information at issue in a Commission proceeding or where the Commission has identified a compelling public interest in disclosing the information.

64. A party may not submit more than one auction application for the 833 Auction. Similarly, a party can participate in the 833 Auction only through a single bidding entity; either it can participate indirectly through a RespOrg or directly by submitting its own application. As in Commission spectrum auctions, if a party submits multiple auction applications, only one application may be the basis for that party to become qualified to bid in the auction.

65. After the initial auction application filing deadline, Somos staff will review all timely submitted applications for the 833 Auction to determine whether each application complies with the application requirements and whether it has provided all required information concerning the applicant's qualifications for bidding. After this review is completed, Somos, in its capacity as auctioneer, will release a public notice identifying the applications as complete or incomplete, and will establish an application resubmission filing window, during which an applicant may make permissible minor modifications to its application to address identified deficiencies. The public notice will include the deadline for resubmitting modified applications. To become a qualified bidder, an applicant must have a complete application ( i.e., have timely corrected any identified deficiencies) and make a timely and sufficient upfront payment. After review of resubmitted applications is complete, Somos will issue a public notice identifying the applicants that are qualified to bid. Somos should release this notice at least five business days before the bidding ( i.e., by December 10, 2019).

66. The 833 Auction Procedures Public Notice provides additional details regarding certain information required to be submitted in the FCC Form 833. In addition, an applicant should consult the Commission's rules, the Toll Free Assignment Modernization Order, and any additional releases specific to the 833 Auction (including instructions on submitting a FCC Form 833 provided by Somos) to ensure that, in addition to the materials described in the 833 Auction Procedures Public Notice, all required information is included in its auction application. To the extent the information in the 833 Auction Procedures Public Notice does not address a potential applicant's specific operating structure, or if the applicant needs additional information or guidance concerning the following disclosure requirements, the applicant should review the educational materials for the 833 Auction and/or use the contact information provided in the 833 Auction Procedures Public Notice to consult with Somos and Commission staff to better understand the information it must submit in its auction application.

67. Each 833 Auction applicant must identify in its auction application any toll free number (from the list of available 833 numbers) on which it may wish to place a bid during the auction. Moreover, for each number it selects, the applicant must identify the party (either itself or another party) for which it is bidding.

68. The 833 Auction Comment Public Notice proposed requiring applicants to select the toll free numbers for which they are interested in bidding and, for each number, identify the party for which it is bidding to allow Somos to verify that a potential subscriber is seeking to bid based on only one application and make it clear to applicants that they can represent only one entity per number, including itself. The Commission received no comments on this proposal. Therefore, based for the reasons set forth in the 833 Auction Comment Public Notice, the Commission adopts this application requirement.

69. The Commission also adopts its proposal to consider any change made to the numbers selected on an application or the party for which an applicant is bidding to be a major modification of the application, which will result in a dismissal of the application. Finalizing the list of potential toll free numbers and parties for which applicants may be bidding provides certainty in the application review and auction qualification process. Therefore, the Commission requires applicants to select the toll free numbers and identify the party for which it is bidding on its application by the application deadline. If qualified to bid in the auction, the entity will not be obligated to place a bid on each of the numbers selected in its application, but an entity will not be able to bid on any numbers that it does not select in its application. If a particular available toll free number is not selected on any auction application, it will not be available in the auction.

70. Moreover, the Commission directs Somos to withhold from public disclosure the 833 toll free numbers selected by an applicant on its auction application until after the bidding is complete. The Commission received no comments on its proposal in the 833 Auction Comment Public Notice to make public the name of party (or parties) for which an applicant is bidding once Somos announces which applications are complete or incomplete. The Commission adopts the proposal because, consistent with the practice in Commission spectrum auctions, it finds that competition will be enhanced by withholding certain information, such as toll free number selections, from other applicants, while still providing bidders with information that will allow them to accurately assess the legitimacy of their auction opponents.

71. Any party interested in participating in the 833 Auction must provide, in its auction application, the same level of ownership disclosure required in Commission spectrum auctions under § 1.2112(a) of the Commission's rules. Thus, each applicant must disclose: (1) The real party or parties in interest of the applicant or of the application; (2) any direct interest holder of 10 percent or greater; (3) any indirect interest holder of 10 percent or greater; and (4) any FCC-regulated entity or applicant for an FCC license in which the applicant, any real party in interest, or any direct interest holder of 10 percent or greater, owns 10 percent or more stock, whether voting or non-voting. An applicant must list all parties holding indirect ownership interests in the applicant as determined by successive multiplication of the ownership percentages for each link in the vertical ownership chain that equals 10 percent or more of the applicant, except that if the ownership percentage for an interest in any link in the chain exceeds 50 percent or represents actual control, it shall be treated and reported as if it were a 100 percent interest.

72. The 833 Auction Comment Public Notice proposed using the ownership disclosure rule used in Commission spectrum auctions. One commenter argued that the disclosure requirements of § 1.2112(a) are unnecessary for the 833 Auction. Specifically, 1-800 Contacts argues that the 10 percent disclosure threshold for direct and indirect interest holders may be relevant to commercial wireless service auctions (because of spectrum aggregation limits) or broadcast auctions (because of multiple ownership, cross ownership and foreign ownership), but not toll free number auctions because toll free numbers have no such limits. 1-800 Contacts therefore argues that the proposed disclosure requirement is “exceedingly burdensome, particularly on prospective auction participants that may be held through complex private investment funds.” In lieu of such disclosure, 1-800 Contacts proposes that auction applicants certify that they and their attributable interest holders are in compliance with the Commission's auction rules, including the prohibition on certain communications.

73. While 1-800 Contacts is correct that the ownership disclosure requirements of § 1.2112 aid in the Commission's enforcement of certain restrictions, such as ownership limits, 1-800 Contacts fails to account for the fact that the 10 percent reporting requirements provide other benefits to the other auction participants. Responding to similar arguments against ownership disclosure made in the Part 1 competitive bidding proceeding, the Commission stated that the 10 percent reporting requirement “helps competing bidders accurately assess the legitimacy of their auction opponents and . . . aids bidders by providing them with information about their auction competitors and alerting them to entities subject to [the Commission's] anti-collusion rules.” Such reasoning applies in the 833 Auction as well. As 1-800 Contacts itself supports the broad application of the prohibition on certain communications, other auction participants rely on the ownership disclosure in auction applications to know with which parties they are prohibited from communicating. Moreover, the Commission disagrees that such disclosure is overly burdensome. Auction applicants have provided such information in a variety of Commission auctions for over 20 years, and such information provides transparency regarding the identity of auction participants—not only to the Commission, but also to other auction participants and the public generally. Thus, the Commission adopts its proposal in the 833 Auction Comment Public Notice to require the same level of ownership disclosure required in § 1.2112(a) of the Commission's rules.

74. To the extent that an applicant may be a party to an auction-related agreement, it must disclose the agreement on its auction application. Specifically, the 833 Auction Comment Public Notice proposed to require an applicant to provide in its auction application a brief description of, and identify each party to, any partnerships, joint ventures, consortia or agreements, arrangements, or understandings of any kind relating to the toll free numbers being auctioned, including any agreements that address or communicate directly or indirectly bids (including specific prices), bidding strategies (including the specific licenses on which to bid or not to bid), or the post-auction market structure, to which the applicant, or any party that controls or is controlled by the applicant, is a party. For purposes of this disclosure, a controlling interest includes all individuals or entities with positive or negative de jure or de facto control of the applicant. The Commission received no comments on this proposal. Because disclosure of these arrangements provides transparency about the auction applicants and any parties with whom they have entered into agreements regarding the toll free numbers being offered in the auction, the Commission adopts this disclosure requirement. Additionally, if an applicant in the 833 Auction is a potential subscriber but is also bidding on behalf of another potential subscriber, it would need to disclose the existence of such an agreement. In such circumstances, the applicant would need to briefly describe the agreement, but must not disclose the toll free number(s) for which it is bidding on behalf of the other potential subscriber(s).

75. In connection with the agreement disclosure requirement, the applicant must certify under penalty of perjury in its auction application that it has described, and identified each party to, any such agreements, arrangements, or understandings into which it has entered. An applicant that enters into any agreement relating to the toll free numbers being auctioned after the auction application deadline is subject to the same disclosure obligations it would be for agreements existing at the application deadline, and it must maintain the accuracy and completeness of the information in its pending auction application.

76. For purposes of making the required agreement disclosures on the auction application, if parties agree in principle on all material terms prior to the application filing deadline, the applicant must provide a brief description of, and identify the other party or parties to, the agreement, even if the agreement has not been reduced to writing. However, if the parties have not agreed in principle by the application filing deadline, the applicant should not describe, or include the names of parties to, the discussions on its application.

77. Finally, the Commission sought comment in the 833 Auction Comment Public Notice on the level of disclosure for auction-related agreements, noting that in its spectrum auctions, an applicant must disclose certain limited information about the agreements in their pre-auction short-form applications ( e.g., the parties to the agreement and a brief summary of the agreements), while winning bidders often may be required to provide more detailed information about the agreements in their post-auction long-form applications. The Commission received no comments on this issue. It concludes that, for the 833 Auction, it is sufficient to require applicants to identify the parties and provide a brief description of the agreement because it will provide enough detail to understand the arrangement without being overly burdensome on auction applicants. When identifying the parties to any agreement, and providing a brief description of such, applicants should take care to avoid providing any details that would indicate specific toll free numbers.

78. An applicant must designate at least one individual as an authorized bidder, and no more than three, in its auction application. In the Commission's spectrum auctions, the rules prohibit an individual from serving as an authorized bidder for more than one auction applicant. This restriction ensures that a single individual with knowledge of the bidding strategies of more than one applicant cannot become even an unwitting conduit of bidding information between those applicants in violation of the Commission's prohibition on certain communications among auction applicants. The Commission finds that a similar restriction would be serve the integrity of the 833 Auction, and accordingly, it prohibits an individual from serving as an authorized bidder for more than one auction applicant in the 833 Auction.

79. The Commission adopts its proposal in the Auction 833 Comment Public Notice to adhere to its practice in Commission spectrum auctions regarding current defaults and delinquencies and to require each applicant in the 833 Auction to certify that it is not currently in default or delinquent on a non-tax debt to the Federal Government. The Commission received no comments on the proposal and takes this step to preserve the integrity of the auction process and to ensure that bidders are capable of meeting their financial commitments. As is the Commission's practice in spectrum auctions, an applicant will be considered a “current defaulter” or “current delinquent” when it, any of its affiliates, any of its controlling interests, or any of the affiliates of its controlling interests, is in default on any payment for any Commission construction permit or license (including a down payment) or is delinquent on any non-tax debt owed to any Federal agency.

80. Also consistent with Commission spectrum auctions, the applicant's status as a current defaulter will be determined as of the auction application deadline. After the deadline, an applicant can dispute the status of the debt, but as noted in the 833 Auction Comment Pubic Notice and consistent with the Commission's practice in spectrum auctions, applicants will not be able to cure the default or delinquency after the auction application deadline to participate in the auction. Thus, prospective applicants should pay any delinquent debts prior to the auction application deadline.

81. In addition to the 833 Auction Procedures Public Notice, applicants are encouraged to review previous guidance on default and delinquency disclosure requirements in the context of the auction application process. Parties are also encouraged to consult with the Somos staff if they have any questions about default and delinquency disclosure requirements.

82. Applicants are encouraged to check the Commission's Red Light Display System for information regarding debts currently owed to the Commission. To access the Commission's Red Light Display System, go to: https://apps.fcc.gov/redlight/login.cfm. The Commission reminds each applicant, however, that its Red Light Display System may not be determinative of an auction applicant's ability to comply with the default and delinquency disclosure requirements ( e.g., an applicant may be delinquent on a non-tax debt to another Federal agency). Thus, an auction applicant's lack of current “red light” status is not necessarily determinative of its eligibility to participate in the auction. The Commission strongly encourages each applicant to carefully review all records and other available Federal agency databases and information sources to determine whether the applicant, or any of its affiliates, or any of its controlling interests, or any of the affiliates of its controlling interests, owes or was ever delinquent in the payment of non-tax debt owed to any Federal agency.

83. In the 833 Auction Comment Public Notice, the Commission sought comment on whether there are other certifications that it should consider requiring auction applicants to make in order to become qualified to bid in the 833 Auction or any legal restrictions that may be relevant. The Commission received no comments and therefore concludes no further certifications are necessary.

84. After the initial application filing deadline, an applicant will be permitted to make only minor changes to its application consistent with the Toll Free Assignment Modernization Order. Examples of minor changes include the deletion or addition of authorized bidders (to a maximum of three), and the revision of addresses and telephone numbers of the applicant, its responsible party, and its contact person. Major modification to an auction application ( e.g., change in toll free number selections, change in the party on whose behalf the applicant will be bidding, certain changes in ownership that would constitute an assignment or transfer of control of the applicant, change in applicant's legal classification that results in a change in control, or change in the required certifications) will not be permitted after the initial auction application filing deadline. If an amendment reporting changes is a “major amendment,” the major amendment will not be accepted and may result in the dismissal of the application.

85. The Commission adopts a procedure, consistent with its spectrum auctions, requiring each applicant in the 833 Auction to maintain the accuracy and completeness of information furnished in its pending auction application. For purposes maintaining the accuracy of the information in an auction application and associated attachments, the application remains pending until the release of a public notice announcing the winning bidders. 833 Auction applicants remain subject to the prohibition on certain communications until the post-auction deadline for making final payments (with a late fee) on winning bids. Also, consistent with the requirements for Commission spectrum auctions, an applicant for the 833 Auction must furnish additional or corrected information to Somos within five business days after a significant occurrence, or amend its auction application no more than five business days after the applicant becomes aware of the need for the amendment. An applicant is obligated to amend its pending application(s) even if a reported change may result in the dismissal of the application because it is subsequently determined to be a major modification.

86. An applicant's ability to modify its auction application in the Somos Auction System may be limited at certain times— e.g., between the closing of the initial filing window and the opening of the application resubmission filing window and between the closing of the resubmission filing window and the release of the public notice announcing the qualified bidders. During these periods, an applicant may be able to view its submitted application, but will be unable to make changes. If an applicant needs to make other permissible minor changes to its auction application at any time other than during the resubmission filing window, it must submit a letter briefly summarizing the changes to its auction application via email to auctionhelp@somos.com. The email summarizing the changes must include a subject line referring to the 833 Auction and the name of the applicant, for example, “Re: Changes to 833 Auction Application of XYZ Corp.” Any attachments to the email must be formatted as Adobe® Acrobat® (PDF) or Microsoft® Word documents. An applicant that submits its changes in this manner must subsequently modify, certify, and submit its auction application(s) electronically in the Somos Auction System once it is available to applicants.

87. As with filing the auction application, any amendment(s) to the application and related statements of fact must be certified by an authorized representative of the applicant with authority to bind the applicant. Applicants should note that submission of any such amendment or related statement of fact constitutes a representation by the person certifying that he or she is an authorized representative with such authority and that the contents of the amendment or statement of fact are true and correct.

88. Questions about amendments to the auction application should be directed to Somos at auctionhelp@somos.com or (844) 439-7666.

89. Each applicant has the sole responsibility for investigating and evaluating all technical and marketplace factors that may have a bearing on the value of the toll free numbers that it is seeking in the 833 Auction. The Commission makes no representations or warranties about the use of the toll free numbers. Each applicant should be aware that the 833 Auction represents an opportunity to receive the right to use certain toll free numbers and that the Commission's statutory authority to add, modify, and eliminate rules governing numbering applies equally to all toll free numbers, whether acquired through the competitive bidding process or otherwise. In addition, the 833 Auction does not constitute an endorsement by the Commission of any particular service, technology, or product, nor does a right to use the toll free numbers constitute a guarantee of business success.

90. An applicant should perform its due diligence research and analysis before proceeding, as it would with any new business venture. In particular, the Commission strongly encourages each potential applicant to review all underlying Commission orders, including the Toll Free Assignment Modernization Order. Each potential applicant should perform due diligence to assure itself that, should it become a winning bidder for the right to use one or more 833 numbers offered in the auction, it will be able to comply with all financial, technical, and legal requirements.

91. The Commission also strongly encourages each applicant for the 833 Auction to continue to conduct its own research throughout the auction in order to determine the existence of pending or future administrative or judicial proceedings that might affect its participation in the auction. Each applicant is responsible for assessing the likelihood of the various possible outcomes and for considering the potential impact on toll free numbers available in the 833 Auction. The due diligence considerations mentioned in the 833 Auction Procedures Public Notice do not constitute an exhaustive list of steps that should be undertaken prior to participating in the 833 Auction. The burden is on the potential applicant to determine how much research to undertake, depending upon the specific facts and circumstances related to its interests.

92. The Commission makes no representations or guarantees regarding the accuracy or completeness of information in its databases or any third-party databases, including, for example, court docketing systems. To the extent the databases may not include all information deemed necessary or desirable by an applicant, it must obtain or verify such information from independent sources or assume the risk of any incompleteness or inaccuracy in said database.

93. Applicants are solely responsible for identifying associated risks and for investigating and evaluating the degree to which such matters may affect their ability to bid on, otherwise acquire, or make use of toll free numbers available in the 833 Auction. Each potential applicant is responsible for undertaking research to ensure that any rights to use toll free numbers won in this auction will be suitable for its business plans and needs. Each potential applicant must undertake its own assessment of the relevance and importance of information gathered as part of its due diligence efforts.

94. The Commission directs Somos to provide detailed educational information to would-be participants before the opening of the auction application filing window on October 7, 2019. Specifically, Somos must provide educational materials on the pre-auction processes in advance of the opening of the application window, beginning with the release of step-by-step instructions for completing the auction application. In addition, the Commission directs Somos to provide an online tutorial covering information on application procedures (including pre-auction preparation, completing auction applications, and the application review process) and bidding procedures. The Commission further directs Somos to provide educational materials on the bidding process and an opportunity to practice the bid upload process in advance of the bidding.

95. As a first step in the 833 Auction application process, an interested party must acquire an “Auction ID” from Somos, which will verify the potential applicant's identity. Any entity that cannot be verified through the Somos verification process, or is otherwise unable to participate in the auction directly, will have the option to participate in the auction through a RespOrg ( i.e., the RespOrg will bid on its behalf and will be responsible for making final payment on any winning bids). The Commission proposed this registration process in the 833 Auction Comment Public Notice and received no comments on it. This registration procedure is consistent with the need to obtain an FCC Registration Number (FRN) to apply for Commission auctions. Therefore, the Commission adopts the proposal and urges interested parties to allow sufficient time prior to the application deadline to register so that, should any party encounter difficulties in the registration process, it would have time to make arrangements to alternatively participate in the auction through a RespOrg.

96. Once Somos verifies an interested party's identity and issues an “Auction ID” to it, the entity must then submit an auction application (FCC Form 833) electronically via the Somos Auction System. Applicants must follow the FCC Form 833 instructions that Somos will release before the application window opens. While no application fee will be required, the applicant must submit a sufficient upfront payment to become a qualified bidder.

97. The auction application will become available with the opening of the initial filing window at 12:00 noon ET on October 7, 2019 and must be submitted prior to 6:00 p.m. ET on October 18, 2019. Late applications will not be accepted. Applicants are strongly encouraged to file early and are responsible for allowing adequate time for filing their applications.

98. After the deadline for filing auction applications, Somos will process all timely submitted applications to determine whether each applicant has complied with the application requirements and provided all information concerning its qualifications for bidding. After review of all the auction applications, Somos will issue a public notice with applicants' initial application status as either complete or incomplete. The public notice will include the deadline for resubmitting corrected applications and a paper copy will be sent to the contact address listed in the auction application for each applicant by overnight delivery. In addition, each applicant with an incomplete application will be sent information on the nature of the deficiencies in its application, along with the name and phone number of a Somos staff member who can answer questions specific to the application.

99. After the initial application filing deadline on October 18, 2019, applicants can make only minor modifications to their applications. Major modifications ( e.g., change toll free number selections, change in the party on whose behalf the applicant will be bidding, certain changes in ownership that would constitute an assignment or transfer of control of the applicant, change in applicant's legal classification that results in a change in control, or change in the required certifications) will not be permitted. After the deadline for resubmitting corrected applications, an applicant will have no further opportunity to cure any deficiencies in its application or provide any additional information that may affect the ultimate determination of whether and to what extent the applicant is qualified to participate in the 833 Auction.

100. Somos staff will communicate only with an applicant's contact person or certifying official, as designated on the auction application, unless the applicant's certifying official or contact person notifies Somos staff in writing that another representative is authorized to speak on the applicant's behalf. Authorizations may be sent by email to auctionhelp@somos.com.

101. After Somos staff review resubmitted applications, Somos will release a public notice identifying applicants that have become qualified bidders for that auction. Qualified bidders are those applicants with submitted auctions applications that are deemed timely filed and complete and who provided a sufficient upfront payment.

102. Each potential bidder must provide an upfront payment in a specified amount for the maximum number of toll free numbers on which it may wish to submit a bid in the 833 Auction. An upfront payment is a refundable deposit made by each auction applicant to establish its eligibility to bid in the auction. Upfront payments protect against frivolous or insincere bidding and provide a source of funds from which to collect payments owed at the close of bidding.

103. In the 833 Auction Comment Public Notice, the Commission proposed that potential bidders provide an upfront payment of $100 per number because it wanted to encourage only serious, qualified bidders, while at the same time, not discourage participation in the auction. The Commission received no comments on the upfront payment proposal. It concludes that the proposed upfront payment requirement and the proposed amount per toll free number will achieve the Commission's stated goals, and therefore, adopts the proposal. Moreover, since the 833 Auction will serve as an experiment in using competitive bidding for assigning toll free numbers, the values of the auctioned numbers can help inform the Commission's decisions regarding upfront payment amounts in any future toll free number auctions.

104. The Commission reiterates that, if a bidder's winning bids total less than its upfront payment, any remaining amount will be refunded to the bidder, minus any default payments that the bidder may owe. Similarly, if a bidder does not have any winning bids, it will be reimbursed the entirety of its upfront payment. Moreover, to become a qualified bidder in the 833 Auction, in addition to having a complete auction application, an interested party must submit a sufficient upfront payment. Thus, at a minimum, an applicant must submit $100 ( i.e., enough to establish eligibility to bid on at least one toll free number). Failure to deliver a sufficient upfront payment as instructed by the applicable upfront payment deadline will result in dismissal of the auction application and disqualification from participation in the auction.

105. In order to be eligible to bid in the 833 Auction, an applicant must submit a sufficient upfront payment to Somos before 6:00 p.m. ET on November 27, 2019. Each applicant is responsible for ensuring timely submission of its upfront payment.

106. All payments must be made in U.S. dollars.

107. The 833 Auction Comment Public Notice proposed to require upfront payments of more than $300 be made via wire transfer. Specifically, the Commission proposed that any upfront payment in excess of $300 must be made through a wire transfer to Somos (or its payment designee), and any amounts under this threshold ( i.e., $300 or less) can be made using an alternative payment collection process, such as Automated Clearing House (ACH). The Commission received no comments on this proposal or the threshold amount. It finds that the proposed approach will ensure prompt and assured transfer of funds for those who plan to bid on more than three toll free numbers, while the alternative payment process should make it easier for individuals or small entities that are interested in only a few toll free numbers, and therefore adopts its proposals. It also adopts the proposal to exclude payments via check or credit card, as such payment processes have increased risks associated with them, which would not be conducive to a timely auction. Thus, the Commission will require payment by wire transfer for any amount in excess of $300 and allow payment by ACH for $300 or less. Regardless of its payment method, each applicant is responsible for obtaining confirmation from its financial institution that its payment to Somos was successful.

108. Wire Transfer Payment Information. If an applicant is providing its upfront payment by wire transfer, it should coordinate with its financial institution well ahead of the due date and allow sufficient time for the transfer to be initiated and completed prior to the deadline. The Commission has repeatedly cautioned auction participants about the importance of planning ahead to prepare for unforeseen last-minute difficulties in making payments by wire transfer. The following information will be needed for wire transfers:

109. ACH Payment Information. If an applicant is providing its upfront payment by ACH, the following information will be needed:

110. Bidders will be able to participate in the 833 Auction over the internet using the Somos Auction System. Only qualified bidders are permitted to bid.

111. The Commission and Somos make no warranties whatsoever, and shall not be deemed to have made any warranties, with respect to the Somos Auction System, including any implied warranties of merchantability or fitness for a particular purpose. In no event shall the Commission, Somos, or any of their officers, employees, or agents, be liable for any damages whatsoever (including, but not limited to, loss of business profits, business interruption, loss of use, revenue, or business information, or any other direct, indirect, or consequential damages) arising out of or relating to the existence, furnishing, functioning, or use of the Somos Auction System. Moreover, no obligation or liability will arise out of the technical, programming, or other advice or service provided by Somos or the Commission in connection with the Somos Auction System.

112. To the extent an issue arises with the Somos Auction System itself, the Commission directs Somos to take all appropriate measures to resolve such issues quickly and equitably. Should an issue arise that is outside the Somos Auction System or attributable to a bidder, including, but not limited to, a bidder's hardware, software, or internet access problem that prevents the bidder from submitting a bid prior to the end of the bidding round, Somos (and the Commission) shall have no obligation to resolve or remediate such an issue on behalf of the bidder. Similarly, if an issue arises due to bidder error using the Somos Auction System, Somos (and the Commission) shall have no obligation to resolve or remediate such an issue on behalf of the bidder. Accordingly, after the close of the bidding round, the results of bid processing will not be altered absent evidence of any failure in the Somos Auction System.

113. As is the case with many business investment opportunities, some unscrupulous entrepreneurs may attempt to use the 833 Auction to deceive and defraud unsuspecting investors. Common warning signals of fraud include the following:

• The first contact is a “cold call” from a telemarketer or is made in response to an inquiry prompted by a radio or television infomercial.

• The offering materials used to invest in the venture appear to be targeted at IRA funds, for example, by including all documents and papers needed for the transfer of funds maintained in IRA accounts.

• The amount of investment is less than $25,000.

• The sales representative makes verbal representations that (a) the Internal Revenue Service, Federal Trade Commission (FTC), Securities and Exchange Commission (SEC), FCC, or other government agency has approved the investment; (b) the investment is not subject to state or Federal securities laws; or (c) the investment will yield unrealistically high short-term profits. In addition, the offering materials often include copies of actual FCC releases, or quotes from FCC personnel, giving the appearance of FCC knowledge or approval of the solicitation.

114. Information about deceptive telemarketing investment schemes is available from the FCC as well as the FTC and SEC. Additional sources of information for potential bidders and investors may be obtained from the following sources:

115. Complaints about specific deceptive telemarketing investment schemes should be directed to the FTC, the SEC, or the National Fraud Information Center at (202) 835-0618.

116. The Commission decided in the Toll Free Assignment Modernization Order that the 833 Auction will be conducted as a single round, sealed-bid auction. All numbers will be available simultaneously for bidding during the round, with the winning bid for each number determined solely by bids for that number, independent of the bids for any other number. Moreover, the Commission also chose to use a Vickrey auction, in which the amount paid by the winning bidder is determined by the second-highest bid. Therefore, in the 833 Auction, the winning bidder for each 833 number will be the bidder that submits the highest bid and it will pay the second-highest bid amount for that number.

117. In the event that a toll free number receives only one bid, the right to use the toll free number will be awarded to the bidder submitting the sole bid and the bidder will not be required to pay anything to acquire the rights to the toll free number because there was no second-highest bid. The Commission proposed this procedure in the 833 Auction Comment Public Notice and received no comments on it. Because it is consistent with using a Vickrey auction, the Commission adopts the proposed procedure for any number in the 833 Auction that receives only one bid. The fact that the winning bidder in this scenario will not be required to pay anything to acquire the rights to the toll free number does not relieve the obligation to pay any other fees, including regulatory fees to the Commission.

118. To provide for the possibility of tied bids, the Commission directs Somos to assign a pseudo-random number to each bid for each toll free number submitted to the 833 Auction. In the event that a toll free number receives two or more tied bids for the highest amount, the winning bidder will be the one with the highest pseudo-random number among the bidders that submitted the tied highest bids. The Commission proposed in the 833 Auction Comment Public Notice using the pseudo-random number to break tied bids and received no comments on it. It also received no comments on the proposal that, in the case of tied bids, the second highest bid amount to be paid by the winning bidder would be the same amount as the winning's placed bid ( i.e., the tied bid amount). The Commission finds these adopted procedures consistent with the Vickrey auction design and therefore adopts them as proposed.

119. The format for the 833 Auction will consist of one bidding round. As noted in the 833 Auction Comment Public Notice, the single round will occur on one day and the Commission anticipates that the round will be open for several hours. The Commission received no comments on the bidding format or bidding period. It directs Somos, in consultation with the Commission, to announce the actual start and finish time of the bidding round at least one week before the start of the auction ( i.e., by December 10, 2019). This approach should provide certainty to the bidders, while providing Somos with flexibility to adjust the bidding depending on the number of qualified bidders.

120. In the 833 Auction Comment Public Notice, the Commission recognized that, because this auction could involve large numbers of bids and the round will be open for several hours, it does not expect that telephone bidding will available in the 833 Auction. The Commission received no comments on this procedure. In the absence of objection and for ease of auction efficiency, the Commission directs Somos to conduct bidding via the internet. While Somos should have telephonic support available to help bidders, the bids must be submitted online. Therefore, bidders are strongly encouraged to formulate back-up contingencies to make sure they can submit their bids online during the bidding round.

121. The Commission adopts the proposal in the 833 Auction Comment Public Notice that, by public notice or by announcement during the auction, the Commission, or Somos in consultation with the Commission, may delay or suspend the auction in the event of a natural disaster, technical failures, administrative or weather necessity, evidence of an auction security breach or unlawful bidding activity, or for any other reason that affects the fair and efficient conduct of competitive bidding. In such cases, the Commission directs Somos to consult with Commission staff about resuming, rescheduling, or canceling the auction in its entirety. If the bidding is delayed or suspended, the Commission may direct Somos to resume the auction starting from the beginning of the scheduled bidding round or for a shorter period, or cancel the auction in its entirety. The Commission will exercise this authority solely at its discretion.

122. To be eligible to bid in the 833 Auction, an applicant must submit a sufficient and timely upfront payment. The amount of the applicant's upfront payment will determine its bidding eligibility— i.e., a qualified bidder may submit only the number of bids reflected in its upfront payment. To help illustrate this point: If an applicant were to select 50 numbers on its application but submits an upfront payment of only $1,000, it would be able to place bids on only 10 numbers (based on an upfront payment of $100 per number).

123. If a qualified bidder attempts to place more bids than its bidding eligibility allows, its entire bid submission will be rejected and the bidder will be given a warning and an opportunity to fix its bids and re-submit. Neither Somos nor the Commission, however, are responsible for bids submitted in which the bidder has exceeded its bidding eligibility. Thus, bidders are strongly encouraged submit their bids well before the end of the single round to account for any issues that may arise.

124. The Commission adopts the proposal in the 833 Auction Comment Public Notice to allow bids only in whole dollar amounts. The Commission directs Somos to provide more detailed instructions on how qualified bidders should submit bids and an opportunity to practice the bid upload process. Bidders are encouraged to become familiar with the process well in advance of the bidding round.

125. A bidder will have the ability to remove any bid(s) that it has placed before the end of the round. The Commission directs Somos to provide specific instructions on how a bidder may do this. If a bidder removes any bid that it has placed before the end of the round, it will not be considered. Once the single round of bidding closes, a bidder may no longer remove, or otherwise withdraw, any of its bids.

126. In the Toll Free Assignment Modernization Order, the Commission stated that, once the bidding concluded, it would release a public notice identifying the winning bidders and establishing the deadline for making final payment for winning bids. The Commission also stated in the Toll Free Assignment Modernization Order that the public notice would also explain how unsold inventory will be assigned after the 833 Auction.

127. In the 833 Auction Comment Public Notice, the Commission included, among the various duties that Somos, as the auctioneer, will perform, the task of announcing the winning bidders. Because Somos will be the entity that will accept and process the bids for the 833 Auction, the Commission reiterates that Somos will announce the winning bids.

128. As for any toll free number offered in the 833 Auction that (i) was not selected on any auction application, (ii) did not receive a bid, or (iii) received one or more bids but the winning bidder defaulted, the Commission will issue a decision on how it will assign such numbers once it reviews the complete results of the 833 Auction. Two commenters advocate, in the case of defaulted bids, that the Commission offer the toll free number to the second highest bidder. The Commission defers until after the auction any decision on how to handle any numbers offered in the 833 Auction with no bid or where the winning bidder defaulted. Once the Commission has all the information available on the 833 Auction experiment, it can better assess how to handle these numbers.

129. Each winning bidder must submit the full payment for its winning bid(s) within 10 business days following release of the public notice announcing the winning bidders. Similar to the final payment procedures in Commission spectrum auctions, the Commission will allow a winning bidder to make its final payment within five additional business days after the applicable deadline, provided it also pays a late fee of 5 percent of the winning bid. The Commission also adopts the proposal in the 833 Auction Comment Public Notice that a winning bidder will declared in default and subject to the applicable default payment if it misses the final payment deadline and also fails to remit the required payment (plus the applicable late fee) by the end of the late payment period.

130. Like upfront payments, final payments must be made in U.S. dollars and will be submitted to Somos. Moreover, the Commission adopts the proposal in the 833 Auction Comment Public Notice to require final payments in excess of $300 to be made through a wire transfer to Somos (or its payment designee) and any amounts under this threshold ( i.e., $300 or less) can be made using ACH. Winning bidders can also use a wire transfer to submit final payments of $300 or less, but also have the option to use ACH. As with allowing ACH for upfront payments below a certain threshold, this alternative payment process should make it easier for individuals or small entities that are the winning bidders for only a few toll free numbers, while ensuring prompt and assured payment of funds for those who had winning bids that exceed the $300 threshold. Moreover, as noted in the 833 Auction Comment Public Notice, the Commission proposed to specifically exclude payments via check or credit card, as such payment processes have increased risks associated with them, which may not be conducive to a timely post-auction process. For these reasons, the Commission adopts the proposal and only allows winning bidders to use ACH as an alternative to wire transfers for their final payments.

131. The Commission directs Somos to return any refunds of upfront payments (minus any final payments and any default payments) within 10 business days after the late final payment deadline ( i.e., within 25 business days of the public notice announcing winning bidders). All refunds of upfront payment balances will be returned to the payer of record unless the payer submits written authorization to Somos instructing otherwise.

132. If a winning bidder fails to make full payment on its bid or otherwise defaults for any reason, it will be subject to a default payment of 35 percent of the defaulted bid. In the Toll Free Assignment Modernization Order, the Commission stated that it expected that the procedures for handling defaults be modeled on those used in the Commission's spectrum auctions, but would defer the decision until the pre-auction process. In the 833 Auction Comment Public Notice, the Commission proposed basing the default payment for the 833 Auction only on a percentage of the defaulted amount, since the Commission has not yet decided if there will be a subsequent auction of toll free numbers. Specifically, the 833 Auction Comment Public Notice proposed a default payment of 35 percent of the defaulted bid, noting that the default percentage is higher than in most of Commission spectrum auctions to compensate for the absence of a deficiency portion of the default payment. The Commission received no comments on the proposed default procedures or percentage. Because the proposed procedure should sufficiently discourage insincere bidding and default, the Commission adopts both the proposed default procedure and default percentage. Moreover, if a default involves gross misconduct, misrepresentation, or bad faith by an applicant, the Commission may declare the applicant and its principals ineligible to bid in future auctions and may take any other action that it deems necessary, including forfeiture of their upfront payment and institution of proceedings to revoke any existing FCC authorizations held by the applicant.

133. Any potential subscriber that directly participates in the 833 Auction and is a winning bidder must work with a RespOrg after the auction to reserve a number in the Toll Free Database in accordance with § 52.101 of the Commission's rules. The Commission adopts the proposal in the 833 Auction Comment Public Notice to require such declaration within 15 business days after the public notice announcing the winning bidders. If a winning bidder experiences problems working with RespOrgs such that it would be unable through no fault of its own to meet this deadline, it could report the problems to Somos, which will hold the number while these issues are resolved, and request waiver of the 15 business day deadline, consistent with the Commission's existing waiver standard.

134. The secondary market, allowing the sale of numbers assigned during the 833 Auction, is a key component of the auction and the Commission's overall toll free assignment modernization efforts. As the Commission explained in the Toll Free Assignment Modernization Order, a secondary market “promotes the efficient operation of an auction” and, consistent with its goal of promoting a market-based approach to toll free number assignment, helps ensure that numbers are assigned to those parties who can most efficiently use them. The Commission thus adopts procedures to allow for a secondary market for those 833 toll free numbers assigned via competitive bidding.

135. To evaluate the operation of this new secondary market, and consistent with the requirement established in the Toll Free Assignment Modernization Order, the Commission directs Somos to collect and maintain information on the parties involved in the secondary market transactions and make that information available to the Commission. Based on the proposal in the 833 Auction Comment Public Notice, and the comments filed in the record, the Commission determines that RespOrgs must submit the information specified below about the parties involved in post-auction secondary market transactions involving their subscribers to Somos within 60 days of the RespOrg's actual knowledge of the transaction. This requirement will be included in Somos's tariff.

136. As an initial matter, the Commission permits parties to acquire and transfer the rights to use all numbers that were assigned via the 833 Auction. Two commenters argue that only 833 numbers that receive multiple bids at auction should be able to be bought and sold in the secondary market. Only one commenter explains the rationale for this argument: CenturyLink claims that the Commission should limit the secondary market in this way because, by allowing every auctioned number to be transferred on the secondary market, the Commission would “afford[ ] a special status and related reporting requirements to numbers based on competitive interest that was fleeting and not demonstrated at the auction.” But CenturyLink misunderstands why the Commission chose to liberalize its secondary market rules for numbers assigned at auction in the first place. The Commission created an exception to the secondary market rules for numbers assigned via competitive bidding to “promote[ ] the efficient operation of an auction” because it “allows subscribers to purchase or sell numbers in response to the outcome of the auction, and limits pre-auction costs associated with estimating which—and how many—numbers a bidder may win.” The proposed limitation would create uncertainty for prospective bidders about whether they will be able to transfer in the secondary market a given number on which they wish to bid and therefore it would frustrate this purpose. The Commission finds no reason to limit the ability of parties to buy and sell numbers in the secondary market beyond what was set forth in the Toll Free Assignment Modernization Order.

137. Consistent with the proposal in the 833 Auction Comment Public Notice, the Commission directs Somos to collect information regarding secondary market transactions. Specifically, the Commission directs Somos to collect contact information of both parties to a transaction including (i) name, (ii) address, (iii) email address, and (iv) phone number. This information will allow the Commission to fully evaluate the operation of the secondary market and will promote certainty and combat fraud in the marketplace by keeping track of change of title, both of which are important components to this toll free number auction experiment. The Commission does not, however, require Somos to collect information on the sale date and price. After reviewing the record, the Commission is persuaded by commenters who argue that subscribers may be hesitant to share sensitive business information such as the sale price, and it is not the Commission's intent with the reporting requirement to impede the robust operation of the secondary market. One commenter contends that the 833 Auction Comment Public Notice, as it relates to the data collection and reporting obligation, “leaves some basic definitional problems unresolved.” This obligation extends to transactions which would violate the Commission's brokering rule but are allowed by the exception for numbers assigned via competitive bidding. Put differently, covered transactions are those which result in the reassignment of an 833 number from one subscriber to another, bypassing the spare pool, which would have violated the Commission's prior first-come, first-served rule.

138. The Toll Free Assignment Modernization Order established a requirement that RespOrgs report the required secondary market transaction information to Somos. To implement this requirement and incentivize RespOrgs to provide this information promptly, the 833 Auction Comment Public Notice proposed that RespOrgs must submit this information to Somos within 60 days of a transaction, against the penalty of denying access to the Toll Free Database until the information is reported, which would be included in the Somos tariff. The Commission adopts this proposal, with the modification based on the record that a RespOrg has 60 days from the time it has actual knowledge of the transaction within which to report the required information. The Commission further adopts the proposal to allow a RespOrg to withhold service from a subscriber until it receives the necessary information. Finally, the Commission clarifies that, in the case of a transfer of a number that is also accompanied by a change of RespOrg, this obligation only applies to the RespOrg providing service to the purchasing subscriber.

139. The Commission is convinced by RespOrg commenters that they may not have reason to know of a secondary market transaction by one of their subscribers in all instances. To address this concern, the Commission provides RespOrgs 60 days from the date of actual knowledge of a transaction to report the information noted above about the secondary market transaction, rather than 60 days from the date of the transaction itself. This change in when the reporting obligation is triggered will avoid a situation in which a RespOrg is denied access to the Toll Free Database for a transaction of which it is unaware. The Commission nonetheless expects RespOrgs to exercise due diligence in monitoring secondary market transactions involving their subscribers.

140. RespOrg commenters argue that this requirement places too large of a burden on RespOrgs because the penalty for non-reporting is too harsh. The Commission disagrees. The Commission believes that the actual knowledge standard adopted reasonably moderates the penalty; the penalty is not triggered until a RespOrg has actual knowledge of a secondary market transaction for 60 days yet nonetheless fails to meet its obligation to report the transaction. In such a situation, the Commission finds the penalty appropriate, given its interest in tracking and analyzing the secondary market in toll free numbers during this experiment. The Commission also concludes that the actual knowledge standard negates the need for Somos to provide RespOrgs a 30-day cure period prior to imposing the penalty; the cure period was a response to the concern that RespOrgs may not know that a secondary market transaction occurred, which is obviated by the adoption of an actual knowledge standard. Further, the penalty for non-reporting is removed when a RespOrg provides Somos with the necessary transaction information. The Commission declines to go further and place an affirmative obligation on subscribers to report secondary market transaction information to Somos, as some commenters suggest, because such an obligation was not contemplated in the Toll Free Assignment Modernization Order. And because the Commission does not find this obligation to be overly burdensome for RespOrgs, it declines to adopt alternative approaches suggested in the record.

141. This document implements the information collections adopted in the Toll Free Assignment Modernization Order and contains additional information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. The Commission is currently seeking PRA approval for information collections related to the auction application process and the secondary market. In the present document, and its related information collection, the Commission requires the following information from potential bidders: (1) Applicant contact and other details; (2) direct ownership interests; (3) indirect ownership interests; (4) real parties in interests; (5) FCC-regulated entities or applicants for a FCC license in which the applicant, any real party in interest, or any direct interest holder of 10 percent or greater owns 10 percent or more stock; (7) whether the applicant is bidding on behalf of other entities; (8) disclosure of any allowable bidding arrangements; (9) the toll free numbers on which the applicant wishes to bid; and (10) any other exhibits or documentation the applicant deems necessary to apply to bid in the auction. Without this collected information, neither the Commission nor Somos (on the Commission's behalf) can hold the 833 Auction, nor can potential bidders participate in it.

142. In addition, with respect to post auction secondary market transactions, Somos will collect contact information on the Commission's behalf from parties to secondary market transactions. This information will allow the Commission to fully evaluate the operation of the secondary market, which is an important component to this toll free number auction experiment.

143. The Commission will send a copy of the 833 Auction Procedures Public Notice, including the Supplemental Final Regulatory Flexibility Analysis, in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act.

144. As required by the Regulatory Flexibility Act of 1980 (RFA), an Initial Regulatory Flexibility Analysis was incorporated in the Notice of Proposed Rulemaking in the Toll Free Assignment Modernization Order, 82 FR 47669, Oct. 13, 2017, pursuant to which the 833 Auction will be conducted. A Supplemental Initial Regulatory Flexibility Analysis (Supplemental IRFA) was incorporated in the 833 Auction Comment Public Notice. The Commission sought written public comments on the Supplemental IRFA. No comments were filed addressing the Supplemental IRFA. A Final Regulatory Flexibility Analysis (FRFA) was also incorporated in the Toll Free Assignment Modernization Order. The Supplemental Final Regulatory Flexibility Analysis (Supplemental FRFA) in the 833 Auction Procedures Public Notice supplements the FRFA to reflect the actions taken in the 833 Auction Procedures Public Notice and conforms to the RFA.

145. Need for, and Objectives of, the Public Notice. The 833 Auction Procedures Public Notice implements the auction procedures to be used by the Commission and Somos for competitive bidding in the 833 Auction for certain toll free numbers in the 833 code. The procedures adopted for the 833 Auction seek to balance three goals: (1) Promoting competition in the auction; (2) avoiding undue burdens on the applicants; and (3) assigning the 833 toll free numbers as expeditiously as possible. Moreover, the 833 Auction Procedures Public Notice provides an overview of the procedures, auction dates and deadlines, requirements for participants, terms and conditions governing the 833 Auction and the post-auction requirements and payment processes.

146. To promote an efficient and fair administration of the competitive bidding process that will benefit all 833 Auction participants, including small entities, the Commission adopts the following procedures:

• Allow potential subscribers to participate in the 833 Auction either through a RespOrg that will bid on all the numbers in which the subscriber is interested in acquiring, or by submitting its own application and bidding for all the numbers in which it is interested;

• require each applicant in the 833 Auction to certify that (1) if it is bidding on its own behalf, it is also not participating in the auction through another entity and/or, if it is bidding on behalf of potential subscribers that it is not aware that the potential subscriber(s) are participating through another applicant; and (2) it, or any commonly-controlled entity, is not submitting multiple applications in the 833 Auction, utilizing the Commission's definitions for control adopted for similar purposes in its spectrum auctions;

• prohibit each applicant in the 833 Auction from cooperating or collaborating with any other applicant with respect to its own, or one another's, or any other competing applicant's bids or bidding strategies, and will be prohibited from communicating with any other applicant in any manner the substance of its own, or one another's, or any other competing applicant's bids or bidding strategies (including the post-auction market for toll free numbers);

• prohibit certain agreements between applicants (whether the applicants are RespOrgs or potential subscribers) in the 833 Auction, and certain auction-related agreements among RespOrgs even where only one of the RespOrgs is an applicant in the 833 Auction;

• require any applicant RespOrg that bids for a potential subscriber to acquire a letter of authorization from the potential subscriber;

• require applicants to first acquire an “Auction ID” from Somos, which will verify the potential applicant's identity, and if any entity cannot be verified through the Somos verification process, it must then participate through a RespOrg;

• require each applicant, on its auction application, (1) identify each number on which it wishes to be able to bid and, for each number, the party (either itself or another entity) for which it is bidding, (2) provide the same level of ownership disclosure required in Commission auctions, (3) disclose any auction-related agreement, and (4) certify that it is not currently in default or delinquent on a non-tax debt to the Federal Government;

• for determining the winning bidder on tied bids for a toll free number, use a pseudorandom number assigned to each bid, and for only one bid received for a toll free number, assign the sole bidder the number and require no payment;

• conduct the 833 Auction using procedures for limited information disclosure;

• require potential bidders provide an upfront payment of $100 per number, and treat all funds that a RespOrg submits as an upfront payment in the auction (regardless of whether the funds came from the RespOrg or a potential subscriber for which the RespOrg is bidding) as the upfront payment of the RespOrg that will be used to offset the final payment obligation for any winning bids of the RespOrg;

• establish a default payment of 35 percent of the defaulted bid;

• require full payment within 10 business days following release of the public notice of the winning bids, or full payment plus a 5 percent late fee, within five additional business days;

• require any potential subscriber that directly participates in the 833 Auction and is a winning bidder to declare its intent to work with a specific RespOrg within 15 business days following release of the public notice of winning bids; and

• require Somos to collect additional information on secondary markets and require RespOrgs submit all required data about post-auction secondary market transactions within 60 days of the RespOrg's knowledge of a transaction.

147. Summary of Significant Issues Raised by Public Comments in Response to Supplemental IRFA. There were no comments filed that addressed the procedures and policies proposed in the Supplemental IRFA.

148. Response to Comments by the Chief Counsel for Advocacy of the Small Business Administration. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comment filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) and to provide a detailed statement of any change made to the proposed procedures as a result of those comments. The Chief Counsel did not file any comments in response to the proposed procedures in the 833 Auction Comment Public Notice.

149. Description and Estimate of the Number of Small Entities to Which the Procedures Will Apply. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the procedures adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.”

150. As noted above, FRFA was incorporated in the Toll Free Assignment Modernization Order. In that analysis, the Commission described in detail the small entities that might be significantly affected. In the 833 Auction Procedures Public Notice, the Commission incorporates by reference the descriptions and estimates of the number of small entities from the previous FRFA in the Toll Free Assignment Modernization Order in WC Docket No. 17-192.

151. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities. The Commission designed the auction application process itself to minimize reporting and compliance requirements for applicants, including small business applicants. Parties desiring to participate in the 833 Auction must file an application in which they certify under penalty of perjury as to their qualifications. Eligibility to participate in bidding is based on an applicant's auction application and certifications, as well as its upfront payment. The Commission decided in the Toll Free Assignment Modernization Order that it will not require applicants to submit a long-form application after the conclusion of the 833 Auction, given the lack of need to verify winning bidders' qualifications in this context and to limit the administrative burden on bidders, including small business entities.

152. The 833 Auction Procedures Public Notice provides instructions for each 833 Auction applicant to maintain the accuracy of its respective auction application electronically using the Somos Auction System and/or by direct communication with Somos. More specifically, small entities and other 833 Auction applicants will be qualified to bid in the auction only if they comply with the following: (1) Submission of an auction application (FCC Form 833) that is timely and is found to be substantially complete; and (2) timely submission of a sufficient upfront payment. An applicant whose application is found to contain deficiencies will have a limited opportunity during a resubmission window to bring its application into compliance with procedures set forth in the 833 Auction Procedures Public Notice.

153. In the second phase of the process, there are additional compliance requirements for winning bidders. As with other winning bidders, any small entity that is a winning bidder will be required to submit the full payment for its winning bid(s) within 10 business days following release of the public notice announcing the winning bidders, or within 15 business days following release of the public notice announcing the winning bidders provided it also pays a late fee of 5 percent of the winning bid.

154. Steps Taken to Minimize the Significant Economic Impact on Small Entities, and Significant Alternatives Considered. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”

155. The Commission believes that the steps described below to facilitate participation in 833 Auction will result in both operational and administrative cost savings for small entities and other auction participants. For example, assigning toll free numbers through competitive bidding will benefit smaller entities rather than the prior first-come first-served basis which favored larger, more sophisticated entities that had invested in obtaining enhanced connectivity to the Toll Free Database. Moreover, the Commission also elected to allow potential subscribers, many of which are smaller entities, the choice between participating directly in the auction or indirectly through a RespOrg. In addition, the Commission created an alternative payment mechanism that will be available for both upfront and final payments, in which applicants can submit payments via ACH instead of wire transfer if the payments are below a $300 threshold. The Commission believes such measures will benefit small entities, who may be interested in only acquiring one or perhaps a few toll free numbers.

156. The procedures adopted in the 833 Auction Procedures Public Notice to facilitate participation in the 833 Auction will result in both operational and administrative cost savings for small entities and other auction participants. In light of the numerous resources that will be available from the Commission and Somos at no cost, the processes and procedures adopted in the 833 Auction Procedures Public Notice should result in minimal economic impact on small entities. For example, prior to the auction, small entities and other auction participants may seek clarification of or guidance on complying with application procedures, reporting requirements, and the bidding system. Small entities as well as other auction participants will be able to avail themselves of (1) a web-based, interactive online tutorial to familiarize themselves with auction procedures, filing requirements, bidding procedures, and other matters related to the 833 Auction and (2) a telephone hotline to assist with issues such as access to or navigation within the auction application system. The Commission and Somos also make copies of Commission decisions available to the public without charge, providing a low-cost mechanism for small businesses to conduct research prior to and throughout the auction. In addition, Somos will post public notices on its website, making this information easily accessible and without charge to benefit all 833 Auction applicants, including small businesses. These steps are made available to facilitate participation in the 833 Auction by all eligible bidders and may result in significant cost savings for small business entities who utilize these alternatives. Moreover, the adoption of bidding procedures in advance of the auctions is designed to ensure that the 833 Auction will be administered predictably and fairly for all participants, including small businesses.

157. The Commission will send a copy of the 833 Auction Procedures Public Notice, including the Supplemental FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the 833 Auction Procedures Public Notice (or summary thereof) will also be published in the Federal Register .

I. Background

DoD published a proposed rule in the Federal Register at 83 FR 62550 on December 4, 2018, to implement the limitations and prohibitions on use of the lowest price technically acceptable (LPTA) source selection process provided in sections 813, 814, and 892 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (Pub. L. 114-328) and sections 822, 832, 882, and 1002 of the NDAA for FY 2018 (Pub. L. 115-91). Sixteen respondents submitted public comments in response to the proposed rule.

DoD reviewed the public comments in the development of the final rule. A discussion of the comments is provided as follows:

No changes from the proposed rule are made in the final rule as a result of the public comments received.

Comment: Several respondents express support for the rule.

Response: DoD acknowledges support for the rule.

Comment: A respondent expresses concern that the rule will be interpreted as a complete prohibition on the use of the LPTA source selection process. The respondent recommends revising the rule to clarify that use of the process is acceptable and expand on the circumstances in which it is or is not appropriate for use in acquisitions.

Response: It is not the intent of the rule to prohibit the use of the LPTA source selection process. The LPTA source selection process is a valuable part of the best value continuum and an acceptable and appropriate source selection approach for many acquisitions. Instead, the intent of the rule is to implement the statutory language, which aims to identify meaningful circumstances that must exist for an acquisition to use the LPTA source selection process and certain types of requirements that will regularly benefit from the use of tradeoff source selection procedures. If a requirement satisfies the limitations for use of the LPTA source selection process, then the process may be used as a source selection approach. Supplemental information to contracting officers on when and from whom to seek additional guidance on whether a requirement satisfies the limitations at 215.101-2-70(a)(1) will be published in the DFARS Procedures, Guidance, and Information (PGI) in conjunction with this final rule.

Comment: One respondent expresses concern about how the agencies using fully automated systems to award contracts are going to implement this rule.

Response: Each Department or agency is required to implement the requirements of this final rule in its acquisition business processes and procedures.

Comment: One respondent expresses support for additional training and guidance that will assist acquisition personnel in making best value decisions.

Response: Training is readily available to DoD personnel on a variety of acquisition topics, including best value decisions. Upon publication of the final rule, the DFARS PGI will be updated to provide contracting officers with information on when and from whom to seek additional guidance when acquiring supplies and services that are impacted by this rule.

Comment: Some respondents recommend applying greater restrictions on the types of acquisitions that can use the LPTA source selection process. For example, a respondent suggests revising this rule to only authorize the use of the LPTA source selection process when acquiring goods that are predominantly expendable in nature, non-technical, or have a short shelf life or life expectancy. Another respondent suggests limiting the use of the LPTA source selection process to only commercial and commercial-off-the-shelf items valued at or below the simplified acquisition threshold, while expressly prohibiting its use for all other requirements.

Response: To ensure that DoD is not denied the benefit of cost and technical tradeoffs in the source selection process, the rule identifies meaningful circumstances that must exist for an individual requirement to use the LPTA source selection process. Each requirement has a unique set of circumstances that should be considered when developing a source selection approach. The LPTA source selection process is a valuable part of the best value continuum and can be used to facilitate an effective and competitive acquisition approach, depending on the circumstances of the acquisition. Limiting the use of the LPTA source selection process to only goods, commercial items under a specific dollar threshold, or other broadly defined groupings does not fully consider the circumstances of an individual requirement and could result in additional and unnecessary time and cost burdens for both Government and industry.

Comment: Some respondents recommend revising the rule to clarify whether each limitation listed at 215.101-2-70(a)(1) applies to supplies, services, or both supplies and services. In particular, a respondent suggests that the rule text be clarified to ensure that the limitations at 215.101-2-70(a)(i) through (iv) are applied to both supplies and services. The respondent also suggests restructuring the rule text by dividing the limitations into two paragraphs: One paragraph that identifies the limitations that apply to the acquisition of supplies, and one that identifies the limitations that apply to the acquisition of services. In contrast, another respondent expresses support for retaining the existing structure of the rule.

Response: The statutory language being implemented by the rule does not categorize the limitations into those that apply to supplies or services. As a result, the list of limitations at 215.101-2-70(a)(1)(i) through (viii) is written to apply to any acquisition that utilizes the LPTA source selection process. In consideration of these limitations, the contracting officer must document the contract file with a description of the circumstances that justify the use of the LPTA source selection process.

One exception is the limitation at 215.101-2-70(a)(1)(vi), which implements paragraph (a)(3) of section 822 of the NDAA for FY 2018 that states the limitation is “with respect to a contract for the procurement of goods;” as such, this rule specifically identifies that goods must meet this limitation.

Comment: Some respondents suggest that additional criteria be added to the list of limitations in order to satisfy Congressional intent. Specifically, one respondent suggests that “non-complex” be added to the additional criteria for goods at 215.101-2-70(a)(1)(vi). The respondent also suggests adding another factor to the list that expressly limits the use of LPTA source selection procedures to procurements where the risk of unsuccessful performance is minimal.

Response: The intent of this rule is to implement the statutory language, which does not include “non-complex” as a criteria to meet when purchasing goods, or a limitation on acceptable performance risk, when using the LPTA source selection process. Comprehensively, the consideration of each limitation at 215.101-2-70(a)(1) provides an effective evaluation of a requirement's suitability to use of the LPTA source selection process and reflects the intent of the statutory language; therefore, no additional limitation criteria are included in this final rule.

Comment: Some respondents indicate that the terms used in the rule are unclear. Specifically, one respondent suggests modifying paragraph 215.101-2-70(a)(1)(ii) to expressly state that “value” includes both qualitative and quantitative value to be realized by DoD. Another respondent advises that it is unclear what “full life-cycle costs” means when acquiring services.

Response: Supplemental guidance will be published in DFARS PGI in conjunction with this final rule to assist contracting officers in documenting the contract file with a determination that the lowest price reflects full life-cycle costs. The term “value” includes monetary and non-monetary benefits, as applicable to the requirement. The term also considers whether DoD is willing to pay more than a minimum price in return for non-monetary benefits ( e.g., greater functionality, higher performance, or lower performance risk). The rule does not place any limitations on the meaning of the term.

Comment: A respondent expresses concern that this rule requires a written justification when using the LPTA source selection process. As acquisition planning already requires the contracting officer to document the acquisition process and the rationale behind the decision to use one process or method over another, the respondent views the documentation required by this rule to be unnecessary. In contrast, another respondent suggests that this rule expand the documentation requirement to include a description and analysis of the all the requirements at 215.101-2-70(a)(1) in order to justify the use of the LPTA source selection process and require the justification to be posted with the solicitation.

Response: This rule implements statutory language that requires a contracting officer document the contract file with the circumstances justifying the use of the LPTA source selection process. The rule does not specify a format or method to be used to meet this statutory requirement. The appropriate format of the justification and the method of incorporation into the contract file is left to the discretion of each Department or agency. When developing a source selection approach, acquisition personnel consider the unique circumstances of a requirement and determine the method that will result in the best value to DoD. Publicizing the justification with the solicitation is not required by statute and could result in increased cost and time burden to both Government and industry.

Comment: A respondent suggests that the rule specify how a contracting officer determines that a procurement is predominately for a specific category of service.

Response: For solicitation and reporting purposes, contracting officers assign each acquisition a product or service code that best represents the predominant dollar amount of supplies or services being procured on an award. This code will determine whether the acquisition is subject to the limitations at 215.101-2-70(a)(2).

Comment: A respondent recommends that the list include services directly related to national security, in order to implement the intent of Congress.

Response: The intent of this rule is to implement the requisite statutory language, which does not include “services directly related to national security” in the list of service categories that must avoid using the LPTA source selection process, to the maximum extent practicable; as such, the rule text does not include such services in 215.101-2-70(a)(2)(i).

Comment: A respondent suggests that the list of services at 215.101-2-70(a)(2)(i) expressly include advisory and assistance services, as the term “knowledge-based professional services” may be misinterpreted to not include advisory and assistance services.

Response: The intent of this rule is to implement the requisite statutory language, which does not explicitly include advisory and assistance services; therefore, the rule text does not identify advisory and assistance services in 215.101-2-70(a)(2)(1).

Comment: Section 880(c) of the NDAA for FY 2019 restricts civilian agencies from using the LPTA source selection process for procurements that are predominately for the same services listed at 215.101-2-70(a)(2)(i), and also includes “health care services and records” and “telecommunication devices and services” to the list. To harmonize the requirements between the FAR and the DFARS or comply with statute, a couple of respondents suggest the rule incorporate the two additional categories from section 880(c) into the restrictions at 215-101-2-70(a)(2).

Response: The intent of this rule is to implement the statutes at sections 813, 814, and 892 of the NDAA for FY 2017, and sections 822, 832, 882, and 1002 of the NDAA for FY 2018. Section 880 of the NDAA for FY 2019 is being implemented via FAR case 2018-016, Lowest Price Technically Acceptable Source Selection Process, and does not apply to DoD.

Comment: One respondent suggests that the two sentences regarding audit services at 215.101-2-70(b)(3) be reversed to state the prohibition upfront and follow with how award decisions shall be made for such services.

Response: The primary intent of the text, as arranged, is to address the action a contracting officer shall take when awarding an auditing contract; therefore, no change is made to the final rule.

An editorial change was made to the rule to update the reference at 213.106-1(a)(2)(ii) from 215.101-70 to 215.101-2-70.

This rule does not create any new DFARS clauses or amend any existing DFARS clauses.

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

This final rule is not subject to E.O. 13771, because this rule is not a significant regulatory action under E.O. 12866.

This rule primarily affects the internal Government procedures, including requirements determination and acquisition strategy decisions, and contract file documentation requirements. However, a final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The FRFA is summarized as follows:

DoD is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement sections of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (Pub. L. 114-328) and the NDAA for FY 2018 (Pub. L. 115-91). These sections establish a preference for the use of the tradeoff source selection process for certain safety items and auditing services; prohibit the use of reverse auctions or the lowest price technically acceptable (LPTA) source selection process for specific supplies and services; and specify criteria for the use of the LPTA source selection process.

No public comments were received in response to the initial regulatory flexibility analysis.

DoD does not have information on the total number of solicitations issued on an annual basis that specified the use of the LPTA source selection process, or the number or description of small entities that are impacted by certain solicitations. However, the Federal Procurement Data System (FPDS) provides the following information for fiscal year 2016:

DoD competitive contracts using FAR part 15 procedures. DoD awarded 18,361 new contracts and orders using competitive negotiated procedures, of which 47% were awarded to 5,221 unique small business entities. It is important to note that FPDS does not collect data on the source selection process used for a solicitation. Therefore, this data includes competitive solicitations using LPTA or tradeoff source selection processes, which will be subject to future considerations and restrictions provided by section 813 of the NDAA for FY 2017 and section 822 of the NDAA for FY 2018.

Personal protective equipment. DoD competitively awarded 9,130 new contracts and orders potentially for combat-related personal protective equipment items that could be impacted by restrictions in section 814 of the NDAA for FY 2017. Of those new contracts and orders, 89% were awarded to 668 unique small business entities.

Aviation critical safety items. As discussed during the rulemaking process for DFARS clause 252.209-7010 published in the Federal Register at 76 FR 14641 on March 17, 2011, the identification of aviation critical safety items occurs entirely outside of the procurement process and is not captured in FPDS. Therefore, it is not possible for DoD to assess the impact of section 814 of the NDAA for FY 2017, as amended by 822 of the NDAA for FY 2018 on small business entities.

Audit-related services. DoD competitively awarded 46 new contracts and orders for audit services that could be impacted by section 1002 of the NDAA for FY 2018. Of those new contracts and orders, 61% were awarded to 17 unique small business entities.

Major defense acquisition programs (MDAPs). The impact to small businesses resulting from implementation of sections 832 and 882 of the NDAA for FY 2018 cannot be assessed, since FPDS does not collect data for MDAPs or specific acquisition phases ( i.e., engineering and manufacturing development (EMD)). Subject matter experts within DoD know of no instances where the LPTA source selection process has been used for procurement of EMD of an MDAP.

This rule does not include any new reporting, recordkeeping, or other compliance requirements.

This rule implements the statutory requirements, as written. There are no known alternative approaches to the rule that would meet the stated objectives of the applicable statutes.

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

Therefore, 48 CFR parts 208, 212, 213, 215, 216, 217, 234, and 237 are amended as follows:

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

The 2019 Pacific cod total allowable catch (TAC) allocated to catcher vessels greater than or equal to 60 feet (18.3m) LOA using pot gear in the BSAI is 13,499 metric tons (mt) as established by the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000, March 13, 2019).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2019 Pacific cod TAC allocated as a directed fishing allowance to catcher vessels greater than or equal to 60 feet (18.3m) LOA using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels greater than or equal to 60 feet (18.3m) LOA using pot gear in the BSAI.

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

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by catcher vessels greater than or equal to 60 feet (18.3m) LOA using pot gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 18, 2019.

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

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