Federal Register Vol. 81, No.149,

I. Background

The National Organic Program (NOP) is authorized by the Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522). The USDA Agricultural Marketing Service (AMS) administers the NOP. Final regulations implementing the NOP, also referred to as the USDA organic regulations, were published December 21, 2000 (65 FR 80548), and became effective on October 21, 2002. Through these regulations, the AMS oversees national standards for the production, handling, and labeling of organically produced agricultural products. Since becoming effective, the USDA organic regulations have been frequently amended, mostly for changes to the National List in 7 CFR 205.601-205.606.

This National List identifies the synthetic substances that may be used and the nonsynthetic substances that may not be used in organic production. The National List also identifies synthetic, nonsynthetic nonagricultural, and nonorganic agricultural substances that may be used in organic handling. The OFPA and the USDA organic regulations, as indicated in § 205.105, specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural substance and any nonsynthetic nonagricultural substance used in organic handling appear on the National List.

As stipulated by the OFPA, the NOSB develops recommendations to amend the National List. The NOSB operates in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2 et seq.), to assist in the evaluation of substances to be used or not used in organic production and handling, and to advise the Secretary on the USDA organic regulations. The OFPA also requires a sunset review of all substances included on the National List within five years of their addition to or renewal on the list. If a listed substance is not reviewed by the NOSB and renewed by the USDA within the five year period, its allowance or prohibition on the National List is no longer in effect. Under the authority of the OFPA, the Secretary can amend the National List through rulemaking based upon proposed amendments recommended by the NOSB.

The NOSB's recommendations to continue existing exemptions and prohibitions include consideration of public comments and applicable supporting evidence that express a continued need for the use or prohibition of the substance(s) as required by the OFPA. Recommendations to either continue or discontinue an authorized exempted synthetic substance (7 U.S.C. 6517(c)(1)) are determined by the NOSB's evaluation of technical information, public comments, and supporting evidence that demonstrate that the substance is: (a) Harmful to human health or the environment; (b) no longer necessary for organic production due to the availability of alternative wholly nonsynthetic substitute products or practices; or (c) inconsistent with organic farming and handling practices.

In accordance with the sunset review process published in the Federal Register on September 16, 2013 (78 FR 61154), this final rule would amend the National List to reflect recommendations submitted to the Secretary by the NOSB on April 30, 2015, to amend the National List to remove five substances allowed as ingredients in or on processed products labeled as “organic.” The exemptions of each substance appearing on the National List for use in organic production and handling are evaluated by the NOSB using the evaluation criteria specified on the OFPA (7 U.S.C. 6517-6518).

After considering public comments and supporting documents, the NOSB determined that one substance allowed on § 205.605(a) and four substances allowed on § 205.605(b) of the National List are no longer necessary or essential for organic handling. The NOSB concluded that practices and other substances are suitable alternatives to egg white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate. AMS has reviewed and accepts the five NOSB recommendations for removal. Based upon these NOSB recommendations, this action amends the National List to remove the exemptions for egg white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate when their use exemptions expire on September 12, 2016.

The USDA organic regulations include an exemption on the National List for egg white lysozyme as a nonsynthetic ingredient for use in organic processed products at § 205.605(a) as follows: Egg white lysozyme (CAS # 9001-63-2). In 2004, egg white lysozyme was petitioned for addition to § 205.605 because it was considered to be an essential processing aid/preservative for controlling bacteria that survived the pasteurization process of milk that is used for cheese manufacture. As recommended by the NOSB, egg white lysozyme was added to the National List on September 12, 2006 (71 FR 53299). The NOSB recommended the renewal of egg white lysozyme during their 2011 sunset review and the listing was renewed in a final rule published on August 3, 2011 (76 FR 46595). The NOSB completed the 2016 sunset review for the allowance of egg white lysozyme at their April 2015 meeting.

AMS published two notices of the NOSB public meetings covering the 2016 sunset review, in Federal Register on September 8, 2014 (79 FR 53162) and on March 12, 2015 (80 FR 12975) with requests for comments. Their purpose was to notify the public that the allowance for egg white lysozyme would expire on September 12, 2016, if not reviewed by the NOSB and renewed by the Secretary. During their sunset review deliberation, the NOSB considered written comments received prior to and during the public meetings on all substances included in the 2016 sunset review. These written comments can be viewed at http://www.regulations.gov by searching for the documents: AMS-NOP-14-0063 (October 2014 NOSB public meeting) and AMS-NOP-15-0002 (April 2015 NOSB public meeting). The NOSB also considered oral comments received during these public meetings which are included in the meeting transcripts available on the AMS Web site at http://www.ams.usda.gov/nop. During their sunset review of egg white lysozyme the NOSB considered two technical reports on enzymes that were requested by and developed for the NOSB in 2011 and 2003, which are also available for review on the AMS Web site.

Public comments provided the NOSB with information about the availability of practice-based alternatives to the use of egg white lysozyme. Such comments provided limited information to support the continued need for egg white lysozyme in organic processed products. Based on those public comments, the NOSB determined that the allowance for egg white lysozyme on the National List in § 205.605(a) is no longer necessary or essential for organic processed products. Subsequently, the NOSB recommended removal of egg white lysozyme from the National List at their April 2015 public meeting.

A proposed rule to remove egg white lysozyme from the National List was published on December 16, 2015 (80 FR 78150). AMS received comments that egg white lysozyme is used in the organic processing of beer, wine and hard cheeses. The prevalence of use in organic processing could not be ascertained from the public comments. Further, the comments did not assert that egg white lysozyme is essential in organic processing. Therefore, consistent with the NOSB recommendation, this final rule amends § 205.605(a) by removing the allowance for egg white lysozyme. This amendment is effective on egg white lysozyme's sunset date, September 12, 2016. After that date, egg white lysozyme will be prohibited in organic processing.

The USDA organic regulations include allowances on the National List for cyclohexylamine, diethylaminoethanol and octadcylamine as processing aids for use in organic processing at § 205.605(b) as follows:

Cyclohexylamine (CAS # 108-91-8)—for use only as a boiler water additive for packaging sterilization.

Diethylaminoethanol (CAS # 100-37-8)—for use only as a boiler water additive for packaging sterilization.

Octadecylamine (CAS # 124-30-1)—for use only as a boiler water additive for packaging sterilization.

Cyclohexylamine, diethylaminoethanol and octadcylamine were added to the National List on September 12, 2006 (71 FR 53299). The NOSB recommended the renewal of cyclohexylamine, diethylaminoethanol and octadcylamine during their 2011 sunset review. AMS published a notice renewing the allowances for cyclohexylamine, diethylaminoethanol and octadcylamine the National List on August 3, 2011 (76 FR 46595).

Subsequently, the NOSB considered the allowances for cyclohexylamine, diethylaminoethanol, and octadcylamine during the 2016 sunset review. AMS published two notices in the Federal Register announcing the NOSB public meetings and requesting public comments on September 8, 2014 (79 FR 53162) and on March 12, 2015 (80 FR 12975). Their purpose was to notify the public that the allowances for cyclohexylamine, diethylaminoethanol and octadcylamine would expire on September 12, 2016, if not reviewed by the NOSB and renewed by the Secretary. During their 2016 sunset review deliberation, the NOSB considered written comments received prior to and during the public meetings on all substances included in the 2016 sunset review. These written comments can be viewed at http://www.regulations.gov by searching for the document: AMS-NOP-14-0063 (October 2014 NOSB meeting) and AMS-NOP-15-0002 (April 2015 NOSB meeting). The NOSB also considered oral comments received during these public meetings which are included in the meeting transcripts available on the AMS Web site at http://www.ams.usda.gov/nop. During their 2016 sunset review, the NOSB considered technical reports on cyclohexylamine, diethylaminoethanol, and octadcylamine that were requested by and developed for the NOSB in 2001; these are available for review on the AMS Web site.

The September 2014 and April 2015 NOSB meeting notices requested information on the continued use of cyclohexylamin, diethylaminoethanol, or octadcylamine as boiler water additives in organic processing. Public comment in response to these requests informed the NOSB that organic processors are phasing out these materials. The comments provided limited information supporting the continued need for the use of cyclohexylamine, diethylaminoethanol, or octadcylamine as boiler water additives. The NOSB cited information from public comments and the potential for adverse human health and environmental impacts in their conclusion that the allowances for cyclohexylamine, diethylaminoethanol, or octadcylamine on § 205.605(b) are no longer necessary or essential in organic processing. Therefore, the NOSB recommended that cyclohexylamine, diethylaminoethanol, and octadcylamine be removed from the National List.

AMS published a proposed rule with a request for comments on December 16, 2015 (80 FR 78150). No public comments were received supporting the continued use of cyclohexylamine, diethylaminoethanol, and octadcylamine in organic processing. Consistent with the NOSB recommendation, this final rule amends § 205.605(b) by removing the allowances for cyclohexylamine, diethylaminoethanol, and octadcylamine. This amendment is effective on cyclohexylamine, diethylaminoethanol, and octadcylamine's current sunset date, September 12, 2016. After that date, these substances are prohibited in organic processing.

The USDA organic regulations include an exemption on the National List for tetrasodium pyrophosphate as an ingredient for use in organic processed products at § 205.605(b) as follows: Tetrasodium pyrophosphate (CAS # 7722-88-5)—for use only in meat analog products. In December 2001, tetrasodium pyrophosphate was petitioned for addition onto § 205.605 for use as an ingredient in organic food processing facilities. As recommended by the NOSB, tetrasodium pyrophosphate was added to the National List on September 12, 2006 (71 FR 53299). In the 2011 sunset review, the NOSB recommended renewing the allowance for tetrasodium pyrophosphate. Consistent with the NOSB recommendation, AMS published a notice in the Federal Register renewing the tetrasodium pyrophosphate exemption on the National List on August 3, 2011 (76 FR 46595).

For the 2016 sunset review, AMS published two notices in Federal Register announcing the NOSB public meetings and requesting comments on September 8, 2014 (79 FR 53162) and on March 12, 2015 (80 FR 12975). The notices informed the public that the tetrasodium pyrophosphate exemption would expire on September 12, 2016, if not reviewed by the NOSB and renewed by the Secretary and to request information on the necessity of tetrasodium pyrophosphate as an ingredient in organic food processing. During their 2016 sunset review deliberation, the NOSB considered written comments received prior to and during the public meetings on all substance exemptions included in the 2016 sunset review. These written comments can be viewed at http://www.regulations.gov by searching for the document: AMS-NOP-14-0063 (October 2014 public meeting) and AMS-NOP-15-0002 (April 2015 public meeting). The NOSB also considered oral comments received during these public meetings which are included in the meeting transcripts available on the AMS Web site at http://www.ams.usda.gov/nop. In addition, during their 2016 sunset review, the NOSB considered two technical reports on tetrasodium pyrophosphate that were requested by and developed for the NOSB in 2014 and 2002; these are available for review on the AMS Web site.

Public comment to the NOSB did not support a continued need for tetrasodium pyrophosphate in the production of organic processed products and informed that various alternative substances are available. Based on public comments and information in the 2014 technical report on tetrasodium pyrophosphate, the NOSB determined that there are alternatives to this substances that may be more compatible with organic production. Therefore, the NOSB determined that the allowance for tetrasodium pyrophosphate on § 205.605(b) is no longer necessary or essential for organic processed products and recommended that tetrasodium pyrophosphate be removed from the National List.

A proposed rule with a request for comments was published on December 16, 2015 (80 FR 78150), and no public comments were received supporting the continued use of tetrasodium pyrophosphate in processed organic products. Consistent with the NOSB recommendation, this final rule amends § 205.605(b) by removing the substance exemption for tetrasodium pyrophosphate. This amendment is effective on tetrasodium pyrophosphate's current sunset date, September 12, 2016. After that date, tetrasodium pyrophosphate will be prohibited in organic processing.

Two notices of public meetings with request for comments were published in Federal Register on September 8, 2014 (79 FR 53162) and on March 12, 2015 (80 FR 12975) to notify the public that substances included in the 2016 sunset review would expire on September 12, 2016, if not reviewed by the NOSB and renewed by the Secretary. The listings for egg white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate were added to the National List on September 12, 2006 (71 FR 53299). The proposed rule to remove the allowance for the use of these substances in organic handling was published on December 16, 2015 (80 FR 78150).

OFPA, as amended (7 U.S.C. 6501-6522), authorizes the Secretary to make amendments to the National List based on proposed recommendations developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop proposed amendments to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under § 205.607 of the USDA organic regulations. The National List Petition Guidelines (NOP 3011) are published in the NOP Handbook which is available on the AMS Web site, http://www.ams.usda.gov/nop. This describes the information to be included for all types of petitions submitted to amend the National List.1 AMS published a revised sunset review process in the Federal Register on September 16, 2013 (78 FR 56811).

This action has been determined to be not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget.

Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This proposed rule is not intended to have a retroactive effect.

States and local jurisdictions are preempted under OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in section 6514(b) of OFPA. States are also preempted under sections 6503 through 6507 of OFPA from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of OFPA.

Pursuant to section 6507(b)(2) of OFPA, a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: (a) Further the purposes of OFPA, (b) not be inconsistent with OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary.

Pursuant to section 6519(f) of OFPA, this proposed rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399), nor the authority of the Administrator of EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136-136(y)).

Section 6520 of OFPA provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

Pursuant to the requirements set forth in the RFA, AMS performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (65 FR 80548). AMS has also considered the economic impact of this action on small entities. The impact on entities affected by this proposed rule would not be significant. The effect of this proposed rule would be to prohibit the use of five nonorganic nonagricultural substances that have limited public support and may no longer be used since nonorganic nonagricultural alternatives to these substances have been developed and implemented by food processors. AMS concludes that the economic impact of removing the nonorganic nonagricultural substance, egg white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate would be minimal to small agricultural firms since alternative practices and nonagricultural products may be commercially available. As such, these substances are proposed to be removed from the National List under this rule. Accordingly, AMS certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Small agricultural service firms, which include producers, handlers, and accredited certifying agents, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000 and small agricultural producers are defined as those having annual receipts of less than $750,000.

According to USDA, National Agricultural Statistics Service (NASS), certified organic acreage exceeded 3.6 million acres in 2014.2 According to NOP's Accreditation and International Activities Division, the number of certified U.S. organic crop and livestock operations totaled over 19,470 in 2014. The list of certified operations is available on the NOP Web site at http://apps.ams.usda.gov/nop/. AMS believes that most of these entities would be considered small entities under the criteria established by the SBA. U.S. sales of organic food and non-food have grown from $1 billion in 1990 to $39.1 billion in 2014, an 11.3 percent growth over 2013 sales.3 In addition, the USDA has 80 accredited certifying agents who provide certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the AMS Web site, at http://www.ams.usda.gov/nop. AMS believes that most of these accredited certifying agents would be considered small entities under the criteria established by the SBA. Certifying agents report 31,020 certified operations worldwide in 2015.4

No additional collection or recordkeeping requirements are imposed on the public by this rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

AMS received nine comments from two consumers, one certifying agent, and six manufacturers (of organic products and ingredients used in organic products) on proposed rule AMS-NOP-15-0052. These written comments can be viewed at http://www.regulations.gov by searching for the document: AMS-NOP-15-0052.

One comment presented general concerns about organic inspections that are not within the scope of this rule. One comment stated general opposition to all chemicals in organic production and agreed with the proposal to remove five nonorganic, nonagricultural substances from the National List.

The comments of a certifying agent and six manufacturers opposed the proposal to remove the allowance for egg white lysozyme in organic processing. These comments indicated that egg white lysozyme is used in the production of wine, beer and hard cheeses. The comments did not specify the prevalence of egg white lysozyme in organic processing or provide compelling information to explain why this substance is essential in organic processing. Therefore, AMS is implementing the NOSB recommendation to remove this substance from the National List.

No comments addressed the proposed removal of cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate.

Consistent with the NOSB recommendations, this final rule amends § 205.605 by removing egg white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate.

This amendment is effective on the current sunset date, September 12, 2016. After that date, these substances will be prohibited in organic processing.

For the reasons set forth in the preamble, 7 CFR part 205 is amended as follows:

Prior to the July 5 final rule's publication, the Pipeline and Hazardous Materials Safety Administration (PHMSA), the Department of Transportation (DOT) agency primarily responsible for developing and enforcing hazardous materials regulations, published its catch-up adjustments for civil penalties, including those for violations of 49 U.S.C. 5123(a)(3). The FAA is amending its catch-up adjustment for 49 U.S.C. 5123(a)(3) to harmonize it with PHMSA's.

On July 5, 2016, the FAA published an interim final rule titled “Revisions to the Civil Penalty Inflation Adjustment Tables” (81 FR 43463). The intent of that rule is to implement the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), Public Law (Pub. L.) 101-410, as amended by the Debt Collection Improvement Act (DCIA) of 1996, Pub. L. 104-134, and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act), Pub. L. 114-74, codified at 28 U.S.C. 2461 note.

The FCPIAA, DCIA, and the 2015 Act require Federal agencies to adjust minimum and maximum civil penalty amounts for inflation to preserve their deterrent impact. The 2015 Act amended the formula and frequency of inflation adjustments. It required an initial catch-up adjustment in the form of an interim final rule, followed by annual adjustments of penalty amounts. The amount of the adjustment must be made using a strict statutory formula that was discussed in the final rule and is corrected as indicated below.

As mentioned above, the FAA's interim final rule was published on July 5, 2016, and included an inflation adjustment for civil penalties associated with hazardous materials training violations under 49 U.S.C. 5123(a)(3). On June 29, 2016, prior to the FAA's civil penalty inflation adjustment publication, the Pipeline and Hazardous Materials Safety Administration (PHMSA), the DOT agency primarily responsible for developing and enforcing hazardous materials regulations, also published its catch-up adjustments for civil penalties, including those for violations of 49 U.S.C. 5123(a)(3). PHMSA, however, came up with a different adjustment to the minimum penalty for training than the FAA. PHMSA read technical amendments made to section 5123(a)(3) in 2012 to be adjusting the minimum penalty back down from a 2009 PHMSA inflation adjustment. See Moving Ahead for Progress in the 21st Century Act (MAP-21), Pub. L. 112-141, 33010, 126 Stat. 405, 837, (2012); 74 FR 68701 (Dec. 29, 2009). It therefore concluded that 2012 was the year the minimum penalty was established or adjusted. FAA concluded that 2005 was the correct year upon which to base adjustments because Congress established the $450 minimum that year and did not change it in its 2012 amendments. Compare Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), Pub. L. 109-59, 7120, 119 Stat. 1144, 1905 (2005) with MAP-21, 126 Stat. at 837. Because PHMSA is the primary DOT agency in the area of hazardous materials safety, and because its calculation is reasonable, the FAA is correcting its catch-up adjustment to harmonize it with PHMSA's.

The FAA is also making technical corrections to its interim final rule. First, it is correcting the effective date noted in the table included in 14 CFR 13.301(c), to reflect the correct effective date of August 5, 2016 (not August 1, 2016). Second, the word “established” is replacing the word “set” when used in reference to the “catch-up adjustment” formula provided by the 2015 Act to make the text of the interim final rule consistent with the statutory text of the 2015 Act. Finally, the FAA is correcting the reference to “section 5123” in the hazmat adjustment example for 49 U.S.C. 5123(a)(1), provided in the background section of the interim final rule, to specifically reference section 5123(a)(1).

In FR Doc. 2016-7004, beginning on page 43463 in the Federal Register of July 5, 2016, make the following corrections:

1. On page 43464, in the second column, under the heading “Background”, in the second paragraph, correct the seventh line by replacing the word “set” with “established”.

2. On page 43464, in the third column, correct the ninth line from the top by replacing the word “set” with “established”.

3. On page 43464, in the third column, correct subparagraph (1) by replacing the word “set” with “established” in both places it is used, replacing the word “reset” with “adjusted” and replacing the words “Section 5123” with “Section 5123(a)(1)”.

4. On page 43464, correct the heading of the second column of the table by replacing the word “set” with “established”.

5. On page 43464, correct the heading of the third column of the table by replacing the word “set” with “established”.

6. On page 43464, correct the second column of the table by replacing “2005” with “2012” in the third line (referencing 49 U.S.C. Statute 5123(a)(3)).

7. On page 43464, correct the fourth column of the table by replacing “1.19397” with “1.02819” in the third line (referencing 49 U.S.C. Statute 5123(a)(3)).

8. On page 43464, correct the fifth column of the table by replacing “537” with “463” in the third line (referencing 49 U.S.C. Statute 5123(a)(3)).

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

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

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

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

On January 29, 2016, Boeing applied for a change to type certificate no. T00021SE to install single-occupant oblique (side-facing) seats with inflatable and 3-point restraint systems in the Model 787-9 airplane.

This airplane is a twin-engine transport-category airplane. It has a 420-passenger capacity and a maximum takeoff weight of 553,000 lbs.

Under the provisions of title 14, Code of Federal Regulations (14 CFR), 21.101, Boeing must show that the Model 787-9 airplane meets the applicable provisions of the regulations listed in type certificate no. T00021SE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model 787-9 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Model 787-9 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

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

The Model 787-9 airplane will incorporate the following novel or unusual design features:

Single-occupant oblique (side-facing) seats with inflatable and 3-point restraint systems requiring dynamic testing.

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

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

Amendment 25-64, dated June 16, 1988, revised the emergency-landing conditions that must be considered in the design of the airplane. It revised the static-load conditions in 14 CFR 25.561 and added a new § 25.562, requiring dynamic testing for all seats approved for occupancy during takeoff and landing. The intent was to provide an improved level of safety for occupants on transport-category airplanes. Because most seating on transport-category airplanes is forward-facing, the pass/fail criteria developed in Amendment 25-64 focused primarily on forward-facing seats. Therefore, the testing specified in the rule did not provide a complete measure of occupant injury in seats that are not forward-facing; although § 25.785 does require that occupants of all seats that are occupied during taxi, takeoff, and landing not suffer serious injury as a result of the inertia forces specified in §§ 25.561 and 25.562.

To address recent research findings and accommodate commercial demand, the FAA developed a methodology to address all fully side-facing seats (i.e., seats oriented in the airplane with the occupant facing 90-degrees to the direction of airplane travel) and has documented those requirements in a set of proposed new special conditions. The FAA issued policy statement PS-ANM-25-03-R1 on November 12, 2012, titled, “Technical Criteria for Approving Side-Facing Seats,” which conveys the injury criteria to be used in the special conditions. Some of those criteria are applicable to oblique seats but others are not, because the motion of an occupant in an oblique seat is different from the motion of an occupant in a fully side-facing seat during emergency landing conditions.

For shallower installation angles, the FAA has granted equivalent level of safety (ELOS) findings for oblique seat installations on the premise that an occupant's kinematics in an oblique seat during a forward impact would result in the body aligning with the impact direction. We predicted that the occupant response would be similar to an occupant of a forward-facing seat, and would produce a level of safety equivalent to that of a forward-facing seat. These ELOS findings were subject to many conditions that reflected the injury-evaluation criteria and mitigation strategies available at the time of issuance of the ELOS. However, review of dynamic test results for many of these oblique seat installations raised concerns that the premise was not correct. Potential injury mechanisms exist that are unique to oblique seats and are not mitigated by the ELOS self-alignment approach even if the occupant appears to respond similarly to a forward-facing seat.

The proposed Model 787 airplane oblique business-class seat installations are novel such that the current Model 787 airplane certification basis does not adequately address occupant protection expectations with regard to the occupant's neck and spine for seat configurations that are oriented at an angle greater than 18-degrees from the airplane centerline. The FAA has previously issued special conditions no. 25-580-SC for the 787, which reflected the best available criteria at the time. However, as the FAA continues research into the injury mechanisms associated with obliquely oriented seats and the means to measure those injuries, the criteria evolve. These special conditions therefore reflect refinements beyond special conditions no. 25-580-SC, and that incorporate the knowledge gained from research. The intent of the special conditions is unchanged. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Boeing proposes to install on Model 787-9 airplanes 3-point restraint systems and airbag devices as a means to protect each occupant from serious injury in the event of an emergency landing, as required by § 25.562(c)(5). Shoulder harnesses have been widely used on attendant seats, flight-deck seats, business jets, and general-aviation airplanes to reduce occupant head injury in the unlikely event of an emergency landing. A passenger-seat 3-point restraint system is defined as a safety belt (pelvic restraint), a single-belt shoulder harness, and the seat structure associated with the harness attachment points. The 3-point restraint system is intended to protect the occupant from serious injury, and the means of protection must take into consideration a range of occupant stature, ranging from a 2-year old child to a 95th percentile male, in addition to the oblique seat orientation. The use of 3- point restraint systems on transport-category airplane passenger seats is rare; however, existing regulations provide an adequate safety standard for these installations. The FAA has issued advisory material on acceptable means of compliance for combined shoulder-harness and safety-belt restraint systems, such as the 3-point restraint system.

Inflatable airbag devices are designed to limit occupant forward excursion in the event of an accident. This will reduce the potential for head injury, thereby reducing the head injury criteria (HIC) measurement. While inflatable airbags are now standard in the automotive industry, the use of an inflatable airbag device is novel for commercial aviation. Special conditions exist for airbags installed on seat belts, known as inflatable lapbelts, which have been installed on Boeing passenger seats. The FAA has also issued special conditions for structure-mounted airbags on the Model 787-9 that are similar to those for inflatable lapbelts, but that account for the differences between the two types of airbag installations.

These special conditions are applicable to the following Boeing Model 787-9 airplanes: AAL ZB 446 (Project PS15-0762), AMX ZB 676 (Project PS15-0588), XIA ZB 812 (Project PS16-0060), and JAL ZB 424 (Project PS15-0723).

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

The substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. Therefore, because a delay would significantly affect the certification of the airplane, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model 787-9 airplanes.

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplane. In addition, the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received.

The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

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

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

On December 24, 2015, Boeing Commercial Airplanes applied for a design change to type certificate no. T00001SE for single-occupant seats installed at an oblique angle to the vertical plane containing the centerline of the airplane, and equipped with inflatable lapbelts, in the Boeing Model 777-300ER airplane. The Model 777-300ER airplane is a wide body, swept wing, conventional tail, twin-engine, turbofan-powered, transport-category airplane.

The type certification basis for the Model 777-300ER airplane is 14 CFR part 25, effective February 1, 1965, as amended by Amendments 25-1 through 25-98, including special conditions 25-295-SC, 25-187A-SC, and 25-569-SC. In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part that are not relevant to these proposed special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 777-300ER airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 777-300ER airplane, as changed, continues to meet the applicable provisions of the regulations listed in type certificate no. T00001SE or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. These regulations will be incorporated into type certificate no. T00001SE after type certification approval of the 777-300ER.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777-300ER airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

The Boeing Model 777-300ER airplane will incorporate the following novel or unusual design features:

The seating configuration proposed by Boeing in certification plan no. 17174, revision A, “Installation of B/E Aerospace Super-Diamond Model Business Class Seats on WE736,” consists of Super Diamond model oblique (side-facing), business-class passenger seats installed in a Boeing Model 777-300ER airplane. These seats will also incorporate inflatable restraints.

The applicable airworthiness regulations do not contain adequate or appropriate safety standards for occupants of seats installed in the proposed configuration. To provide a level of safety equivalent to that afforded to occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. Although special conditions no. 25-187A-SC, 25-295-SC, and 25-569-SC already apply to the 777-300ER, they do not directly address the complex occupant-loading conditions introduced by this oblique (side-facing) seat configuration, nor do they reflect the latest findings of on-going research.

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

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

Amendment 25-64, dated June 16, 1988, revised the emergency-landing conditions that must be considered in the design of the airplane. It revised the static-load conditions in § 25.561 and added a new § 25.562, requiring dynamic testing for all seats approved for occupancy during takeoff and landing. The intent was to provide an improved level of safety for occupants on transport-category airplanes. Because most seating on transport-category airplanes is forward-facing, the pass/fail criteria developed in Amendment 25-64 focused primarily on forward-facing seats. Therefore, the testing specified in the rule did not provide a complete measure of occupant injury in seats that are not forward-facing. However, § 25.785 does require that occupants of all seats occupied during taxi, takeoff, and landing not suffer serious injury as a result of the inertia forces specified in §§ 25.561 and 25.562.

To address recent research findings and accommodate commercial demand, the FAA developed a methodology to address all fully side-facing seats (i.e., seats oriented in the airplane with the occupant facing 90 degrees to the direction of airplane travel) and has documented those requirements in a set of proposed new special conditions. The FAA issued policy statement PS-ANM-25-03-R1 on November 12, 2012, titled, “Technical Criteria for Approving Side-Facing Seats,” which conveys the injury criteria to be used in the special conditions. Some of those criteria are applicable to oblique seats, but others are not because the motion of an occupant in an oblique seat is different from the motion of an occupant in a fully side-facing seat during emergency-landing conditions.

For shallower installation angles, the FAA has granted equivalent level of safety (ELOS) findings for oblique seat installations on the premise that an occupant's kinematics in an oblique seat during a forward impact would result in the body aligning with the impact direction. We predicted that the occupant response would be similar to an occupant of a forward-facing seat, and would produce a level of safety equivalent to that of a forward-facing seat. These ELOS findings were subject to many conditions that reflected the injury-evaluation criteria and mitigation strategies available at the time of issuance of the ELOS. However, review of dynamic test results for many of these oblique seat installations raised concerns that the premise was not correct. Potential injury mechanisms exist that are unique to oblique seats and are not mitigated by the ELOS self-alignment approach even if the occupant appears to respond similarly to a forward-facing seat.

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

As discussed above, these special conditions are applicable to the Boeing Model 777-300ER airplane. These special conditions can be applied to oblique seats installed in accordance with Boeing certification plan no. 17174, revision A, “Installation of B/E Aerospace Super-Diamond Business Class Seats on WE736.”

The FAA will amend these special conditions, or issue new special conditions, should unusual occupant response in the required dynamic tests, or additional research into occupant-injury mechanisms, indicate that these special conditions are inadequate. Any future special conditions would include due public notice for comment.

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

Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the Federal Register; however, as the certification date for the Boeing Model 777-300ER airplane, as modified by Boeing, is imminent, the FAA finds that good cause exists to make these special conditions effective upon publication in the Federal Register.

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is impracticable because the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

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

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

On March 29, 2012, Gulfstream applied for a type certificate for their new Model GVII-G500 airplane. This transport-category, twin-engine airplane will be a business jet capable of accommodating up to 19 passengers. The maximum takeoff weight is 91,000 lbs.

Under title 14, Code of Federal Regulations (14 CFR) 21.17, Gulfstream must show that the Model GVII-G500 airplane meets the applicable provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-129.

If the Administrator finds that the applicable airworthiness regulations (i.e., part 25) do not contain adequate or appropriate safety standards for the Model GVII-G500 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, Model GVII-G500 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36. The FAA must issue a finding of regulatory adequacy under section 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

The Model GVII-G500 airplane will incorporate the following novel or unusual design feature:

A fly-by-wire flight-control system that governs the pitch, yaw, and roll axes of the airplane.

Active flight-control systems are capable of providing automatic responses to inputs from sources other than pilots. Active flight-control systems have been expanded in function, effectiveness, and reliability such that fly-by-wire flight controls, without a manual backup system to address system failures, are becoming standard equipment. As a result of these advancements in flight-control technology, the current safety standards contained in 14 CFR part 25 do not provide an adequate basis to address an acceptable level of safety for airplanes so equipped. Instead, certification of these systems has been achieved by issuance of special conditions under the provisions of § 21.16.

For example, stability-augmentation systems (SASs), and to a lesser extent load alleviation systems (LASs), have been used on transport airplanes for many years. Past approvals of these systems were based on individual findings of equivalent level of safety with existing rules and through special conditions. Advisory circular 25.672-1 was issued November 11, 1983, to provide an equivalent means of compliance under the provisions of § 21.21(b)(1) for SAS, LAS, and flutter control systems (FCSs), another type of active flight-control system.

Although autopilots are also considered active flight-control systems, their control authority has historically been limited such that the consequences of system failures could be readily counteracted by the pilot. Now, autopilot functions are integrated into the primary flight controls and given sufficient control authority to maneuver the airplane to its structural design limits. This advanced technology, with its expanded authority, requires a new approach to account for the interaction of control systems and structures.

The usual deterministic approach to defining the loads envelope contained in 14 CFR part 25 does not fully account for system effectiveness and system reliability. These automatic systems may be inoperative, or may operate in a degraded mode with less than full system authority. Therefore, it is necessary to determine the structural factors of safety and operating margins such that the joint probability of structural failures, due to application of loads during system malfunctions, is not greater than that found in airplanes equipped with earlier-technology control systems. To achieve this objective, it is necessary to define the failure conditions with their associated frequency of occurrence to determine the structural factors of safety and operating margins that will ensure an acceptable level of safety.

Earlier automatic control systems usually provided two states; either fully functioning or totally inoperative. The flightcrew readily detected these conditions. The new active flight-control systems have failure modes that allow the system to function in a degraded mode without full authority. The flightcrew do not readily detect these degraded modes. Therefore, monitoring systems are required on these new systems to provide an annunciation of degraded system capability.

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

As discussed above, these special conditions are applicable to the Gulfstream Model GVII-G500 airplane. Should Gulfstream apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

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

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, good cause exists for adopting these special conditions upon publication in the Federal Register.

The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Gulfstream Model GVII-G500 airplane.

For airplanes equipped with systems that affect structural performance, either directly or as a result of a failure or malfunction, the influence of these systems and their failure conditions must be taken into account when showing compliance with the requirements of 14 CFR part 25, subparts C and D.

The following criteria must be used for showing compliance with these special conditions for airplanes equipped with flight-control systems, autopilots, stability-augmentation systems, load-alleviation systems, flutter-control systems, fuel-management systems, and other systems that either directly, or as a result of failure or malfunction, affect structural performance. If these special conditions are used for other systems, it may be necessary to adapt the criteria to the specific system.

1. The criteria defined herein only address the direct structural consequences of the system responses and performance. They cannot be considered in isolation, but should be included in the overall safety evaluation of the airplane. These criteria may, in some instances, duplicate standards already established for this evaluation. These criteria are only applicable to structure the failure of which could prevent continued safe flight and landing. Specific criteria that define acceptable limits on handling characteristics or stability requirements, when operating in the system degraded or inoperative mode, are not provided in these special conditions.

2. Depending upon the specific characteristics of the airplane, additional studies that go beyond the criteria provided in these special conditions may be required to demonstrate the airplane's capability to meet other realistic conditions, such as alternative gust or maneuver descriptions for an airplane equipped with a load-alleviation system.

3. The following definitions are applicable to these special conditions.

a. Structural performance: Capability of the airplane to meet the structural requirements of 14 CFR part 25.

b. Flight limitations: Limitations that can be applied to the airplane flight conditions following an in-flight occurrence, and that are included in the airplane flight manual (e.g., speed limitations, avoidance of severe weather conditions, etc.).

c. Operational limitations: Limitations, including flight limitations, that can be applied to the airplane operating conditions before dispatch (e.g., fuel, payload and master minimum-equipment list limitations).

d. Probabilistic terms: Terms such as probable, improbable, and extremely improbable, as used in these special conditions, are the same as those used in § 25.1309.

e. Failure condition: This term is the same as that used in § 25.1309. However, these special conditions apply only to system-failure conditions that affect the structural performance of the airplane (e.g., system-failure conditions that induce loads, change the response of the airplane to inputs such as gusts or pilot actions, or lower flutter margins).

1. General. The following criteria will be used in determining the influence of a system and its failure conditions on the airplane structure.

2. System fully operative. With the system fully operative, the following apply:

a. Limit loads must be derived in all normal operating configurations of the system from all the limit conditions specified in 14 CFR part 25, subpart C (or defined by special conditions or equivalent level of safety in lieu of those specified in subpart C), taking into account any special behavior of such a system or associated functions, or any effect on the structural performance of the airplane that may occur up to the limit loads. In particular, any significant nonlinearity (rate of displacement of control surface, thresholds, or any other system nonlinearities) must be accounted for in a realistic or conservative way when deriving limit loads from limit conditions.

b. The airplane must meet the strength requirements of 14 CFR part 25 (static strength, residual strength), using the specified factors to derive ultimate loads from the limit loads defined above. The effect of nonlinearities must be investigated beyond limit conditions to ensure that the behavior of the system presents no anomaly compared to the behavior below limit conditions. However, conditions beyond limit conditions need not be considered when it can be shown that the airplane has design features that will not allow it to exceed those limit conditions.

c. The airplane must meet the aeroelastic stability requirements of § 25.629.

3. System in the failure condition. For any system-failure condition not shown to be extremely improbable, the following apply:

a. At the time of occurrence. Starting from 1g level flight conditions, a realistic scenario, including pilot corrective actions, must be established to determine the loads occurring at the time of failure and immediately after the failure.

i. For static-strength substantiation, these loads, multiplied by an appropriate factor of safety that is related to the probability of occurrence of the failure, are ultimate loads to be considered for design. The factor of safety is defined in Figure 1, below.

ii. For residual-strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in special condition 3.a.(i). For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iii. Freedom from aeroelastic instability must be shown up to the speeds defined in § 25.629(b)(2). For failure conditions that result in speeds beyond VC/MC, freedom from aeroelastic instability must be shown to increased speeds, so that the margins intended by § 25.629(b)(2) are maintained.

iv. Failures of the system that result in forced structural vibrations (oscillatory failures) must not produce loads that could result in detrimental deformation of primary structure.

b. For the continuation of the flight. For the airplane in the system-failed state, and considering any appropriate reconfiguration and flight limitations, the following apply:

i. The loads derived from the following conditions (or used in lieu of the following conditions) at speeds up to VC/MC (or the speed limitation prescribed for the remainder of the flight) must be determined:

1. The limit symmetrical maneuvering conditions specified in §§ 25.331 and 25.345.

2. the limit gust and turbulence conditions specified in §§ 25.341 and 25.345.

3. the limit rolling conditions specified in § 25.349, and the limit unsymmetrical conditions specified in §§ 25.367, and 25.427(b) and (c).

4. the limit yaw-maneuvering conditions specified in § 25.351.

5. the limit ground-loading conditions specified in §§ 25.473 and 25.491.

ii. For static-strength substantiation, each part of the structure must be able to withstand the loads in special condition 3.b.(i), multiplied by a factor of safety depending on the probability of being in this failure state. The factor of safety is defined in Figure 2, below.

iii. For residual-strength substantiation, the airplane must be able to withstand two-thirds of the ultimate loads defined in paragraph 3.b.(ii) of these special conditions. For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iv. If the loads induced by the failure condition have a significant effect on fatigue or damage tolerance, then their effects must be taken into account.

v. Freedom from aeroelastic instability must be shown up to a speed determined from Figure 3, below. Flutter clearance speeds V′ and V″ may be based on the speed limitation specified for the remainder of the flight using the margins defined by § 25.629(b).

vi. Freedom from aeroelastic instability must also be shown up to V′ in Figure 3, above, for any probable system-failure condition, combined with any damage required or selected for investigation by § 25.571(b).

b. Consideration of certain failure conditions may be required by other sections of 14 CFR part 25 regardless of calculated system reliability. Where analysis shows the probability of these failure conditions to be less than 10−9, criteria other than those specified in this paragraph may be used for structural substantiation to show continued safe flight and landing.

4. Failure indications. For system-failure detection and indication, the following apply:

a. The system must be checked for failure conditions, not extremely improbable, that degrade the structural capability below the level required by 14 CFR part 25, or that significantly reduce the reliability of the remaining system. As far as reasonably practicable, the flightcrew must be made aware of these failures before flight. Certain elements of the control system, such as mechanical and hydraulic components, may use special periodic inspections, and electronic components may use daily checks, in lieu of detection and indication systems, to achieve the objective of this requirement. These certification-maintenance requirements must be limited to components that are not readily detectable by normal detection-and-indication systems, and where service history shows that inspections will provide an adequate level of safety.

b. The existence of any failure condition, not extremely improbable, during flight, that could significantly affect the structural capability of the airplane, and for which the associated reduction in airworthiness can be minimized by suitable flight limitations, must be signaled to the flightcrew. For example, failure conditions that result in a factor of safety between the airplane strength and the loads of 14 CFR part 25, subpart C below 1.25, or flutter margins below V″, must be signaled to the crew during flight.

5. Dispatch with known failure conditions. If the airplane is to be dispatched in a known system-failure condition that affects structural performance, or that affects the reliability of the remaining system to maintain structural performance, then the provisions of these special conditions must be met, including the provisions of special condition 2 for the dispatched condition, and special condition 3 for subsequent failures. Expected operational limitations may be taken into account in establishing Pj as the probability of failure occurrence for determining the safety margin in Figure 1. Flight limitations and expected operational limitations may be taken into account in establishing Qj as the combined probability of being in the dispatched failure condition and the subsequent failure condition for the safety margins in Figures 2 and 3. These limitations must be such that the probability of being in this combined failure state, and then subsequently encountering limit load conditions, is extremely improbable. No reduction in these safety margins is allowed if the subsequent system-failure rate is greater than 10−3 per hour.

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

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

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

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

On October 9, 2014, Embraer applied for a change to Type Certificate No. TC00062IB for a synthetic vision system (SVS) and enhanced flight vision system (EFVS) on a head-up display (HUD) in Model EMB-545 and EMB-550 airplanes. These airplanes are business jets capable of accommodating up to 9 passengers (EMB-545) or 12 passengers (EMB-550).

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Embraer must show that the Model EMB-545 and EMB-550 airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. TC00062IB, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type certification basis.” In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model EMB-545 and EMB-550 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, Embraer Model EMB-545 and EMB-550 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

The Embraer Model EMB-545 and EMB-550 airplanes will incorporate the following novel or unusual design feature: an enhanced-flight vision system and synthetic vision system that display video imagery on a head-up display.

Video display on the HUD constitutes new and unusual technology for which the FAA has no certification criteria. Section 25.773 does not permit visual distortions and reflections in the pilot's view out the airplane windshield that could interfere with the pilot's normal duties, and was not written in anticipation of such technology. Special conditions are therefore issued as prescribed under the provisions of § 21.16.

For many years the FAA has approved, on transport-category airplanes, the use of HUD that display flight symbols without a significant visual obstruction of the outside view. When the FAA began to evaluate the display of enhanced vision-system (EVS) imagery on the HUD, significant potential to obscure the outside view became apparent, contrary to the requirements of 14 CFR 25.773. This rule does not permit distortions and reflections in the pilot-compartment view, through the airplane windshield, that interferes with normal duties, and the rule was not written in anticipation of such technology. The video image potentially interferes with the pilot's ability to see the natural scene in the center of the forward field of view. Therefore, the FAA issued special conditions for such HUD/EVS installations to ensure that the level of safety required by § 25.773 would be met even when the image might partially obscure the outside view. While many of the characteristics of EVS and SVS video differ in some ways, they have one thing in common: the potential for interference with the outside view through the airplane windshield.

Although the pilot may be able to see around and through small, individual, stroke-written symbols on the HUD, the pilot may not be able to see around or through the image that fills the display without some interference of the outside view. Nevertheless, the vision-system video may be capable of meeting the required level of safety when considering the combined view of the image and the outside scene visible to the pilot through the image. It is essential that the pilot can use this combination of image and natural view of the outside scene as safely and effectively as the pilot-compartment view currently available without the vision-system image.

Because § 25.773 does not provide for any alternatives or considerations for such a new and novel system, the FAA establishes safety requirements that assure an equivalent level of safety and effectiveness of the pilot-compartment view as intended by that rule. The purpose of these special conditions is to provide the unique pilot-compartment-view requirements for the EFVS/SVS installation.

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

As discussed above, these special conditions are applicable to the Embraer Model EMB-545 and EMB-550 airplanes. Should Embraer apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

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

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register.

The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions apply to all Synthetic Vision System (SVS) and Enhanced Flight Vision System (EFVS) on Head-Up Display (HUD) installations on the Embraer Model EMB-545 and EMB-550 airplanes in lieu of the requirements of § 25.773 at Amendment 25-129:

1. The synthetic vision system (SVS) or enhanced flight vision system (EFVS) imagery on the head-up display (HUD) must not degrade the safety of flight or interfere with the effective use of outside visual references for required pilot tasks during any phase of flight in which it is to be used.

2. To avoid unacceptable interference with the safe and effective use of the pilot-compartment view, the SVS or EFVS device must meet the following requirements:

a. The SVS or EFVS design must minimize unacceptable display characteristics or artifacts (e.g. noise, “burlap” overlay, running water droplets, terrain shadowing against a dark background) that obscure the desired image of the scene, impair the pilot's ability to detect and identify visual references, mask flight hazards, distract the pilot, or otherwise degrade task performance or safety.

b. Control of SVS or EFVS image-display brightness must be sufficiently effective in dynamically changing background (ambient) lighting conditions to avoid pilot distraction, impairment of the display that would distract the pilot, impairing the pilot's ability to detect and identify visual references, masking of flight hazards, or otherwise degrading task performance or safety. If automatic control for image brightness is not provided, it must be shown that a single manual setting is satisfactory for the range of lighting conditions encountered during a time-critical, high-workload phase of flight (e.g., low-visibility instrument approach).

c. A readily accessible control must be provided that permits the pilot to immediately deactivate and reactivate display of the SVS or EFVS image on demand, without removing the pilot's hands from the primary flight controls (yoke or equivalent) or thrust control.

d. The SVS or EFVS image on the HUD must not impair the pilot's use of guidance information, or degrade the presentation and pilot awareness of essential flight information displayed on the HUD, such as alerts, airspeed, attitude, altitude and direction, approach guidance, wind-shear guidance, traffic-alert and collision-avoidance system (TCAS) resolution advisories, or unusual attitude recovery cues.

e. The SVS or EFVS image and the HUD symbols, which are spatially referenced to the pitch scale, outside view, and image, must be scaled and aligned (i.e., conformal) to the external scene. In addition, the SVS or EFVS image and the HUD symbols—when considered singly or in combination—must not be misleading, cause pilot confusion, or increase workload. Airplane attitudes or cross-wind conditions may cause certain symbols (e.g., the zero-pitch line or flight-path vector) to reach field-of-view limits, such that they cannot be positioned conformally with the image and external scene. In such cases, these symbols may be displayed, but with an altered appearance that makes the pilot aware that they are no longer displayed conformally (for example, “ghosting”). The combined use of symbology and runway image may not be used for path monitoring when path symbology is no longer conformal.

f. A HUD system installed to display SVS or EFVS images must, if previously certified, continue to meet all of the requirements of the original approval.

3. The display of the SVS or EFVS image must not degrade the safety and performance of the pilot tasks associated with the use of the pilot-compartment view. Pilot tasks that must not be degraded by the SVS or EFVS image include:

a. Detection, accurate identification, and maneuvering, as necessary, to avoid traffic, terrain, obstacles, and other hazards of flight.

b. Accurate identification and utilization of visual references required for every task relevant to the phase of flight.

4. Appropriate limitations must be stated in the operating limitations section of the airplane flight manual to prohibit the use of the SVS or EFVS for functions that have not been found to be acceptable.

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions are impracticable because the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

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

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

On November 30, 2012, FedEx applied for a supplemental type certificate for the installation and operation of a HUD and an EFVS in the Boeing Model 767-300F airplane. The original type certificate for the 767-300F airplanes is A1NM. The Boeing Model 767-300F is a transport-category, cargo-carrying airplane that operates with a crew of two.

Under the provisions of 14 CFR 21.101, FedEx must show that the Boeing Model 767-300F airplane, as changed, continues to meet the applicable provisions of the regulations listed in type certificate no. A1NM, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type certification basis.” The regulations are listed in Type Certificate Data Sheet No. A1NM, which covers all variants of Boeing Model 767 airplanes. In addition, the certification basis includes certain special conditions and exemptions that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 767-300F airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Model 767-300F airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

The Boeing Model 767-300F airplane will incorporate the following novel or unusual design feature: An EFVS that projects a video image derived from a FLIR camera through the HUD. The EFVS image is projected in the center of the “pilot compartment view,” which is governed by § 25.773. The image is displayed with HUD symbology and overlays the forward outside view. Therefore, § 25.773 does not contain appropriate safety standards for the EFVS display.

Video display on the HUD constitutes new and unusual technology for which the FAA has no certification criteria. Section 25.773 does not permit visual distortions and reflections in the pilot's view out the airplane windshield that could interfere with the pilot's normal duties, and was not written in anticipation of such technology. Special conditions are therefore issued as prescribed under the provisions of § 21.16.

For many years, the FAA has approved, on transport-category airplanes, the use of HUD that display flight symbols without a significant visual obstruction of the outside view. When the FAA began to evaluate the display of enhanced vision-system (EVS) imagery on the HUD, significant potential to obscure the outside view became apparent, contrary to the requirements of 14 CFR 25.773. This rule does not permit distortions and reflections in the pilot-compartment view, through the airplane windshield, that interfere with normal duties, and the rule was not written in anticipation of such technology. The video image potentially interferes with the pilot's ability to see the natural scene in the center of the forward field of view. Therefore, the FAA issued special conditions for such HUD/EVS installations to ensure that the level of safety required by § 25.773 would be met even when the image might partially obscure the outside view. EVS video has the potential for causing interference with the outside view through the airplane windshield.

Although the pilot may be able to see around and through small, individual, stroke-written symbols on the HUD, the pilot may not be able to see around or through the image that fills the display without some interference of the outside view. Nevertheless, the EVS video may be capable of meeting the required level of safety when considering the combined view of the image and the outside scene visible to the pilot through the image. It is essential that the pilot can use this combination of image and natural view of the outside scene as safely and effectively as the pilot-compartment view currently available without the vision-system image.

Because § 25.773 does not provide for any alternatives or considerations for such a new and novel system, the FAA establishes safety requirements that assure an equivalent level of safety and effectiveness of the pilot-compartment view as intended by that rule. The purpose of these special conditions is to provide the unique pilot-compartment-view requirements for the EFVS installation.

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

As discussed above, these special conditions are applicable to the Boeing Model 767-300F airplane. Should FedEx apply at a later date for a supplemental type certificate to modify any other model included on type certificate no. A1NM to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on Boeing 767-300F airplanes. It is not a rule of general applicability and it affects only the applicant who applied to the FAA for approval of these features on the airplane.

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

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type-certification basis for Boeing Model 767-300F airplanes modified by FedEx.

1. Enhanced flight vision system (EFVS) imagery on the head-up display (HUD) must not degrade the safety of flight or interfere with the effective use of outside visual references for required pilot tasks during any phase of flight in which it is to be used.

2. To avoid unacceptable interference with the safe and effective use of the pilot compartment view, the EFVS device must meet the following requirements:

a. The EFVS design must minimize unacceptable display characteristics or artifacts (e.g., noise, “burlap” overlay, running water droplets) that obscure the desired image of the scene, impair the pilot's ability to detect and identify visual references, mask flight hazards, distract the pilot, or otherwise degrade task performance or safety.

b. Automatic control of EFVS display brightness must be sufficiently effective, in dynamically changing background (ambient) lighting conditions, to prevent full or partial blooming of the display that would distract the pilot, impair the pilot's ability to detect and identify visual references, mask flight hazards, or otherwise degrade task performance or safety. If automatic control for image brightness is not provided, it must be shown that a single manual setting is satisfactory for the range of lighting conditions encountered during a time-critical, high-workload phase of flight (e.g., low visibility instrument approach).

c. A readily accessible control must be provided that permits the pilot to immediately deactivate and reactivate display of the EFVS image on demand without removing the pilot's hands from the primary flight controls (yoke or equivalent) or thrust control.

d. The EFVS image on the HUD must not impair the pilot's use of guidance information, or degrade the presentation and pilot awareness of essential flight information displayed on the HUD, such as alerts, airspeed, attitude, altitude and direction, approach guidance, windshear guidance, traffic alert and collision avoidance system (TCAS) resolution advisories, or unusual attitude recovery cues.

e. The EFVS image and the HUD symbols, which are spatially referenced to the pitch scale, outside view, and image, must be scaled and aligned (i.e., conformal) to the external scene. In addition, the EFVS image and the HUD symbols, when considered singly or in combination, must not be misleading, cause pilot confusion or increase workload. Airplane attitudes or crosswind conditions may cause certain symbols (e.g., the zero-pitch line or flight path vector) to reach field-of-view limits such that they cannot be positioned conformally with the image and external scene. In such cases, these symbols may be displayed but with an altered appearance, which makes the pilot aware that they are no longer displayed conformally (for example, “ghosting”).

f. A HUD system used to display EFVS images must, if previously certified, continue to meet all of the requirements of the original approval.

3. The safety and performance of the pilot tasks associated with the use of the pilot compartment view must not be degraded by the display of the EFVS image. Pilot tasks that must not be degraded by the EFVS image include:

a. Detection, accurate identification, and maneuvering, as necessary, to avoid traffic, terrain, obstacles, and other hazards of flight.

b. Accurate identification and utilization of visual references required for every task relevant to the phase of flight.

4. Use of EFVS for instrument approach operations must be in accordance with the provisions of § 91.175(l) and (m), and § 121.651, where applicable. Appropriate limitations must be stated in the operating limitations section of the airplane flight manual to prohibit the use of the EFVS for functions that have not been found to be acceptable.

The substance of these special conditions has been subject to the public comment process with no comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

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

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

On February 15, 2014, Associated Air Center applied for a supplemental type certificate for inflatable airbag systems in the Boeing Model 747-8 airplane. This airplane, currently approved under type certificate no. A20WE, is a private, not-for-hire, not-for-common-carriage business jet with a head-of-state interior. This airplane has a maximum passenger seating capacity of 113. Twelve of the passenger-seating positions include single-place side-facing seats, each of which include an airbag system to protect against leg-flail injuries.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Associated Air Center must show that the Model 747-8 airplane, as changed, continues to meet the applicable provisions of the regulations listed in type certificate no. A20WE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

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

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

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

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

The Boeing Model 747-8 airplane, as modified by Associated Air Center, will incorporate the following novel or unusual design features: An airbag system to limit axial rotation of the upper leg, due to leg flail, of occupants in single-place side-facing seats.

The Boeing Model 747-8 airplane has an interior configuration that includes single-place side-facing seats. These seats include an airbag system in the shoulder belt, per Special Conditions no. 25-606-SC; and an airbag system to limit the axial rotation of the upper leg (femur).

Side-facing seats are considered a novel design for transport-category airplanes that include title 14, Code of Federal Regulations (14 CFR) part 25, Amendment 25-64, in their certification bases and were not anticipated when those airworthiness standards were issued. Therefore, the existing regulations do not provide adequate or appropriate safety standards for occupants of side-facing seats. The FAA issued Special Conditions no. 25-606-SC to address the certification of single- and multiple-place side facing seats for Boeing 747-8 airplanes. Those special conditions include condition 2(e), which requires the axial rotation of the upper-leg (femur) to be limited to 35 degrees in either direction from the nominal seat position. Associated Air Center has developed an airbag system that will be installed close to the floor and that is designed to limit the axial rotation of the upper-leg.

Serious leg injuries, such as femur fracture, can occur in aviation side-facing seats, injuries that could threaten the occupant's life directly or eliminate the occupant's ability to evacuate the airplane. Limiting upper-leg axial rotation to a conservative limit of 35 degrees (approximately the 50-percentile range of motion) should also limit the risk of serious leg injury. Research suggests that the angle of rotation can be determined by observing lower-leg flailing in typical high-speed video of the dynamic tests. Alternately, the anthropomorphic test dummy could be instrumented to directly measure upper-leg axial rotation. This requirement complies with the intent of the § 25.562(a) injury criteria in preventing serious leg injury.

To comply with special condition 2(e) on some seat positions, Associated Air Center proposes to install leg-flail airbags. This airbag is not addressed in Special Conditions no. 25-606-SC. Therefore, the FAA must issue new special conditions to address this leg-flail airbag installation. These special conditions are similar to other special conditions previously issued for airbags.

Special Conditions no. 25-606-SC for the airbag system in the shoulder belt are based on previous special conditions for airbag systems on forward-facing seat lap belts with some changes to address the specific issues of side-facing seats.

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

As discussed above, these special conditions are applicable to the Boeing Model 747-8 airplane as modified by Associated Air Center. Should Associated Air Center apply at a later date for a supplemental type certificate to modify any other model included on type certificate no. A20WE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

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

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

The authority citation for these special conditions is as follows:

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

In addition to the requirements of §§ 25.562 and 25.785, and Special Conditions no. 25-606-SC, the following special conditions are part of the type certification basis for Boeing 747-8 airplanes with leg-flail airbag systems installed on side-facing seats.

1. For seats with leg-flail airbag systems, these systems must deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th-percentile male. At some buttock popliteal length and effective seat-bottom depth, the lower legs will not be able to form a 90-degree angle with the upper leg; at this point, the lower-leg flail would not occur. The leg-flail airbag system must provide a consistent approach to prevention of leg flail throughout that range of occupants whose lower legs can form a 90-degree angle relative to the upper legs when seated upright in the seat. Items that need to be considered include, but are not limited to, the range of occupants' popliteal height, the range of occupants' buttock popliteal length, the design of the seat effective height above the floor, and the effective depth of the seat bottom cushion.

2. The leg-flail airbag system must not be susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.

3. Deployment of the leg-flail airbag system must not introduce injury mechanisms to the seated occupant, or result in injuries that could impede rapid egress.

4. Inadvertent deployment of the leg-flail airbag system, during the most critical part of the flight, must either meet the requirement of § 25.1309(b), or not cause a hazard to the airplane or its occupants. This also includes preventing inadvertent airbag deployment from a static discharge.

5. The leg-flail airbag system must not impede rapid egress of occupants from the airplane 10 seconds after airbag deployment.

6. The leg-flail airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lightning (§ 25.1316) and HIRF (§ 25.1317) are incorporated by reference for the purpose of measuring lightning and HIRF protection.

7. The leg-flail airbag system must function properly after loss of normal airplane electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the leg-flail airbag system does not have to be considered.

8. The leg-flail airbag system must not release hazardous quantities of gas, sharp injurious metal fragments, or particulate matter into the cabin.

9. The leg-flail airbag system installation must be protected from the effects of fire such that no hazard to occupants will result.

10. A means must be available to verify the integrity of the leg-flail airbag system's activation system prior to each flight, or the leg-flail airbag system's activation system must reliably operate between inspection intervals. The FAA considers that the loss of the leg-flail airbag system's deployment function alone (i.e., independent of the conditional event that requires the leg-flail airbag system's deployment) is a major-failure condition.

11. The airbag inflatable material may not have an average burn rate of greater than 2.5 inches per minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).

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

Airworthiness Directive 2016-14-01, Amendment 39-18582 (81 FR 44983, July 12, 2016) (“AD 2016-14-01”), currently requires identification of the manufacturer, part number, and serial number of the ram air turbine (RAT), and re-identification and modification of the RAT if necessary, for certain Airbus Model A330-200 Freighter series airplanes; Model A330-200 and A330-300 series airplanes; Model A340-200 and A340-300 series airplanes; Model A340-500 series airplanes; and Model A340-600 series airplanes.

As published, table 1 to paragraph (j) of the regulatory text contains typographical errors in two part numbers. Table 1 to paragraph (j) of the AD incorrectly refers to RAT P/Ns 1720934C and 1720934D. Those part numbers should have been 1702934C and 1702934D.

Airbus has issued the following service information, which describes procedures for identifying the supplier, part number, and serial number of the installed RAT actuator; modifying the RAT; and re-identifying the RAT actuator and RAT.

• Service Bulletin A330-29-3126, dated June 12, 2014.

• Service Bulletin A340-29-4097, dated June 12, 2014.

• Service Bulletin A340-29-5025, dated June 16, 2014.

Hamilton Sundstrand has issued Service Bulletins ERPS06M-29-21, Revision 1, dated April 14, 2015; and ERPS33T-29-7, dated June 6, 2014. This service information describes procedures for identifying the affected RAT actuator and RAT part numbers and serial numbers, modifying affected actuators, and re-identifying affected RAT actuators and RATs.

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.

This document corrects an error and correctly adds the AD as an amendment to 14 CFR 39.13. Although no other part of the preamble or regulatory information has been corrected, we are publishing the entire rule in the Federal Register.

The effective date of this AD remains August 16, 2016.

Since this action only corrects typographical errors, it has no adverse economic impact and imposes no additional burden on any person. Therefore, we have determined that notice and public procedures are unnecessary.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

The Commission amended 18 CFR 154.112(a), addressing the filing of “special rate schedules,” reflecting special operating arrangements previously certificated pursuant to part 157 of the Commission's regulations (such as for the exchange of natural gas).1

As published in the 2015 edition of the Code of Federal Regulations, the final regulations (effective November 3, 2008) contained an error. Order No. 714 revised the fourth, fifth and sixth sentences to reflect new filing requirements. However, the published version of 18 CFR 154.112(a) incorrectly retained language from the earlier version that should have been superseded. The Commission did not intend to retain the superseded sentences. This correcting amendment removes the incorrectly-retained language. This correction does not affect 18 CFR 154.112(b) which remains unchanged.

Accordingly, 18 CFR part 154 is corrected by making the following correcting amendments:

Background

We use the listings in appendix 1 to subpart P of part 404 of 20 CFR at the third step of the sequential evaluation process to evaluate claims filed by adults and children for benefits based on disability under the title II and title XVI programs.1 20 CFR 404.1520(d), 416.920(d), 416.924(d). The listings are in two parts: Part A has listings criteria for adults and Part B has listings criteria for children. If you are age 18 or over, we apply the listings criteria in part A when we assess your impairment or combination of impairments. If you are under age 18, we first use the criteria in part B of the listings when we assess your impairment(s). If the criteria in part B do not apply, we may use the criteria in part A when those criteria give appropriate consideration to the effects of your impairment(s). 20 CFR 404.1525(b), 416.925(b).

In this final rule, we are extending the dates on which the listings for the following four body systems will no longer be effective as set out in the following chart:

We continue to revise and update the listings on a regular basis, including those body systems not affected by this final rule.2 We intend to update the four listings affected by this final rule as quickly as possible, but may not be able to publish final rules revising these listings by the current expiration dates. Therefore, we are extending the expiration dates listed above.

We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 in promulgating regulations. Section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5). Generally, the APA requires that an agency provide prior notice and opportunity for public comment before issuing a final regulation. The APA provides exceptions to the notice-and-comment requirements when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest.

We have determined that good cause exists for dispensing with the notice and public comment procedures. 5 U.S.C. 553(b)(B). This final rule only extends the date on which four body system listings will no longer be effective. It makes no substantive changes to our rules. Our current regulations 3 provide that we may extend, revise, or promulgate the body system listings again. Therefore, we have determined that opportunity for prior comment is unnecessary, and we are issuing this regulation as a final rule.

In addition, for the reasons cited above, we find good cause for dispensing with the 30-day delay in the effective date of this final rule. 5 U.S.C. 553(d)(3). We are not making any substantive changes to the listings in these body systems. Without an extension of the expiration dates for these listings, we will not have the criteria we need to assess medical impairments in these four body systems at step three of the sequential evaluation processes. We therefore find it is in the public interest to make this final rule effective on the publication date.

We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the requirements for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB did not review it. We also determined that this final rule meets the plain language requirement of Executive Order 12866.

We certify that this final rule does not have a significant economic impact on a substantial number of small entities because it affects only individuals. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.

These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.

For the reasons set out in the preamble, we are amending Appendix 1 to subpart P of part 404 of chapter III of title 20 of the Code of Federal Regulations as set forth below.

Regulated entities. The Administrator determined that this action is subject to the provisions of CAA section 307(d). See CAA section 307(d)(1)(V) (the provisions of CAA section 307(d) apply to “such other actions as the Administrator may determine). These are amendments to existing regulations and could affect your facility if a CAA-related ruling by a federal court affects your operations.

Entities potentially affected directly by this final rulemaking include the EPA and any state/local/tribal governments implementing delegated EPA programs. Entities potentially affected indirectly by this final rule include owners and operators of sources of air emissions that are subject to CAA regulations.

In addition to being available in the docket, an electronic copy of this notice will be posted at: https://www.epa.gov/nsr/nsr-regulatory-actions. Upon publication in the Federal Register, only the published version may be considered the final official version of the notice, and will govern in the case of any discrepancies between the Federal Register published version and any other version.

The information presented in this document is organized as follows:

On August 19, 2015, the EPA proposed revisions to the Regional Consistency regulations. The preamble to the proposal provided a history of the Regional Consistency regulations, as well as a discussion of a recent D.C. Circuit Court decision, National Environmental Development Association's Clean Air Project v. EPA, 752 F.3d 999 (D.C. Cir. 2014), that led to the EPA's proposed revisions to alter the agency's internal process to address court decisions having local or regional applicability. See 80 FR 50252-54, August 19, 2015. This discussion addressed the basis for the proposed changes and our rationale for why we believe the revisions are necessary. This final rulemaking notice does not repeat that discussion, but refers interested readers to the preamble of the proposed rule for this background.

The 60-day public comment period for the proposed rule was extended 15 days in response to commenters' requests and closed on November 3, 2015. In Section III of this document, we briefly summarize the revisions and summarize and respond to significant comments.

In this action, we are making three specific revisions to the general consistency policy reflected in the Regional Consistency regulations, 40 CFR part 56, to accommodate the implications of judicial decisions addressing locally or regionally applicable actions. First, we are revising 40 CFR 56.3 to add a provision to acknowledge an exception to the “policy” of uniformity to provide that a decision of a federal court adverse to the EPA that arises from a challenge to locally or regionally applicable actions will not automatically apply uniformly nationwide. This ensures that only decisions of the U.S. Supreme Court and decisions of the United States Court of Appeals for the D.C. Circuit Court that arise from challenges to “nationally applicable regulations . . . or final action” will apply uniformly to the challenged regulations or action nationwide in all instances.1 Second, we are revising 40 CFR 56.4 to add a provision to clarify that the EPA Headquarters offices' employees will not need to issue mechanisms or revise existing mechanisms developed under 40 CFR 56.4(a) to address federal court decisions adverse to the EPA arising from challenges to “locally or regionally applicable” actions. Lastly, we are revising 40 CFR 56.5(b) to clarify that EPA Regional offices' employees will not need to seek Headquarters office concurrence to diverge from national policy or interpretation if such action is required by a federal court decision adverse to the EPA arising from challenges to locally or regionally applicable actions.2

In the proposed rule, we explain in detail why the revisions are reasonable and consistent with general principles of common law and the CAA. See 80 FR 50254. We summarize those discussions in Sections III.B.1 through 6 of this document.

As explained more fully in the proposed rule, federal courts are courts of limited jurisdiction and only have the authority to hear and decide cases granted to them by Congress. A court of appeals generally hears appeals from the district courts located within its circuit, and the circuit is delineated by the states it contains. As a general matter, while an opinion from one circuit court of appeals may be persuasive precedent, it is not binding on other courts of appeals. See Hart v. Massanari, 266 F.3d 1155, 1172-73 (9th Cir. 2001).

By revising the regulations in part 56 to fully accommodate intercircuit nonaquiescence, the EPA is acting consistently with the purpose of the federal judicial system by allowing the robust percolation of case law through the circuit courts until such time as U.S. Supreme Court review is appropriate.3 As the U.S. Supreme Court has noted, preventing the government from addressing an issue in more than one forum “would substantially thwart the development of important questions of law by freezing the first final decision rendered on a particular legal issue.” United States v. Mendoza, 464 U.S. 154, 160 (1984). In light of this important function, the U.S. Supreme Court has sought to preserve government discretion to relitigate an issue across different circuits. Id. at 163. Thus, though circuit conflict may undermine national uniformity of federal law to some degree for some period of time, it also advances the quality of decisions interpreting the law over time. See generally Atchison, Topeka & Santa Fe Ry. Co. v. Pena, 44 F.3d 437, 446 (7th Cir. 1994) (J. Easterbrook, concurring) (agencies and courts balance whether “it is more important that the applicable rule of law be settled” or “that it be settled right”) (internal quotation and citation omitted).

Various commenters stated that intercircuit nonaquiescence is inappropriate or bad policy. One commenter stated that the EPA's preference for pursuing intercircuit nonacquiescence to promote judicial resolution is not the appropriate approach. The commenter said that the current Regional Consistency regulations allow for judicial appeals, but also ensure uniformity pending the resolution of conflicting court opinions. The commenter also noted that it is uncertain whether ultimate resolution of circuit splits will ever occur under the proposed revisions. The commenters cited to the EPA's reference to the U.S. Supreme Court's review of EDF v. Duke, 549 U.S. 561, 581 (2007) as evidence that the EPA can do what the D.C. Circuit advised in NEDACAP, which is to request review of an adverse decision and put regulated entities on notice that the EPA disagreed with the lower court's decision.

A couple of commenters noted that some courts, as well as law review articles and legal commentary, have taken an unfavorable view of the doctrine of intercircuit nonacquiescence. The commenters state that the EPA failed to account for the criticisms in its proposal notice. They also took the position that the doctrine is particularly ill-suited for the CAA and its myriad of regulations.

Another commenter stated that the EPA's proposal to follow intercircuit nonacquiescence is an attempt to refuse to adjust policies in the face of clear, adverse judicial decisions. The commenter suggested that if the EPA disagrees with a court over a matter of enormous import, then the issue should either be elevated to the U.S. Supreme Court or addressed in rulemaking reviewable by the D.C. Circuit.

One commenter argued that intercircuit nonacquiescence is not the only path to judicial resolution. Rather, following an adverse decision the EPA could apply a policy change nationwide and allow the various circuits courts to review that new interpretation, while maintaining consistency in the meantime.

The EPA disagrees with the commenters; the approach advocated by these commenters would grant every court unlimited nationwide jurisdiction. Rather than being merely persuasive, a decision in one circuit thus would become binding precedent in other circuits; such a result is inconsistent with the court system established by Congress and years of case law. Robust review by a variety of courts, to allow for percolation of an issue before it reaches the U.S. Supreme Court, leads to a more thorough analysis of an issue.

In response to those commenters who claim the EPA failed to account for arguments against intercircuit nonacquiescence, the EPA disagrees. The fact that the EPA reaches a different conclusion regarding the benefits of intercircuit nonacquiescence does not mean that the EPA has failed to consider all sides of the argument. Moreover, as explained more fully in Section III.B.2 of this document, the EPA's position recognizes the unique aspects of CAA § 307(b) and its specific placement of review of nationally applicable regulations and policies in the D.C. Circuit.

The EPA has reviewed the case law and law review articles cited by the commenters and notes that some of the commenters appear to confuse the concept of intracircuit nonacquiescence, which involves an agency not following a court decision even within the circuit which issued the decision, and intercircuit nonacquiescence, which involves an agency following a court decision in the circuit that issued the decision, but not in other circuits. Some of the cases and law review articles cited by commenters in support of their arguments against intercircuit nonacquiescence involved intracircuit nonacquiescence. See, e.g., Johnson v. U.S. R.R. Retirement Board, 969 F.2d 1082, 1090 (D.C. Cir. 1992), cert. denied, 507 U.S. 1029 (1993) (involving the intracircuit nonacquiescence of the Retirement Board); Lopez v. Heckler, 713 F.2d 1432, 1434 (9th 1983) (involving intracircuit nonacquiescence of the Secretary of Health and Human Resources); Holden v. Heckler, 584 F. Supp. 463 (NE. Ohio 1984) (involving the Secretary of Health and Human Resources failure to follow Sixth Circuit precedent); Diller & Morawetz, Intracircuit Nonacquiescence and the Breakdown of the Rule of Law, 881 Yale L.J. 801 (1990) (analyzing intracircuit nonacquiescence); Coen, The Constitutional Case Against Intracircuit Nonacquiescence, 75 Minn. L. Rev. 1339 (1991) (same).4 Upon close reading, many of the materials cited by commenters support the EPA's revisions. For example, the D.C. Circuit stated that:

While some commenters stated that intercircuit nonacquiescence is particularly ill-fitted to the CAA because of its myriad of regulations, the EPA concludes that it is the vast array of regulations which makes these revisions appropriate. A facility may already have to track compliance with a variety of CAA regulations, and the revisions allow that facility to presume that the national interpretation or policy applicable to those regulations will continue to apply to it, unless a court with jurisdiction over the facility issues a court decision or the EPA undertakes appropriate procedures to change that national interpretation or policy. It arguably would be more burdensome on regulated entities to track not only the national interpretation of all the regulations and policies that apply to their facilities, but also all the court decisions across the country regarding those regulations or policies. These revisions to the Regional Consistency rule are intended to provide, as much as possible, a stable policy environment for facilities.

The approach suggested by one commenter that the EPA could provide uniformity by applying an adverse court decision nationally, without otherwise changing the underlying national policy or interpretation, is not feasible when different circuits issue different interpretations. When circuit splits occur, the EPA would have to apply different interpretations in the conflicting circuits; the only question is which interpretation applies in those circuits that had not ruled on the issue. The final revisions to the Regional Consistency regulations answer this question by establishing the presumption that the EPA will continue to apply the national policy nationwide, except for those geographic areas impacted by the adverse decision. However, the approaches set forth by commenters fail to address the situation when a second court addresses an issue already ruled on by another court, and issues a conflicting decision. The EPA's final revisions account for this possibility by maintaining national policies nationwide, except in those limited geographic areas covered by adverse court decisions. A particular advantage of these revisions is that they can be implemented in a predictable and straightforward manner regardless of the number of lower court decisions or the potential conflicts among those decisions.

To the extent commenters are concerned that circuit splits would never be resolved by the U.S. Supreme Court, this possibility is not caused by, or unique to, the revised Regional Consistency regulations. First, as noted in the proposed rule, the U.S. Supreme Court is more likely to grant review if such a split between two or more circuits occurs. 80 FR 50255. Second, when the EPA successfully maintains its position before a court, the entity challenging that position may seek further review. Finally, the public will still have the option to file a petition with the EPA requesting a change in the nationally applicable regulations or policy in the event that EPA declines to change national policy in response to an adverse ruling in a lower court. Assuming statutory timing and other jurisdictional prerequisites are met, the EPA's final response to that petition may be challenged in the D.C. Circuit, which is, under the CAA, the appropriate venue for obtaining a nationally applicable court decision on the national policy. See, e.g., Oljato Chapter of Navajo Tribe v. Train, 515 F.2d 654 (D.C. Cir. 1975).

We disagree with the commenter who stated that the revisions are an attempt by the EPA to ignore adverse decisions.5 Quite the contrary, the final revisions clearly establish a mechanism whereby the EPA Regions located in the geographic area(s) covered by an adverse decision may and should begin following that decision in those geographic areas immediately, without having to seek concurrence from Headquarters. The revisions also recognize that the EPA may, as appropriate, change national policy in response to an adverse decision. But until the EPA undertakes the appropriate process to effectuate that change, national policy continues to apply elsewhere nationwide.

Revisions ensure that the Regional Consistency regulations are in harmony with the CAA's judicial review provisions at section 307(b). The ability of the various courts of appeals to hear appeals of decisions of the EPA is specifically addressed in the statute. In 1977, at the same time it added the directive for the EPA to promulgate what would ultimately become the Regional Consistency regulations, Congress amended the Act to ensure that the D.C. Circuit Court, and no other circuit courts, would review nationally applicable regulations. By placing review of nationally applicable decisions in the D.C. Circuit Court alone, Congress struck the balance between the countervailing values of improved development of the law on the one hand and national uniformity on the other. At the same time, Congress left the door open to intercircuit conflicts by granting jurisdiction over locally or regionally applicable final actions to the regionally-based courts of appeal. These revisions maintain the balance that Congress struck in CAA section 307(b)(1). There is nothing in the language or intent of CAA § 301(a)(2) that trumps the clear statutory directive of CAA § 307(b)(1) establishing which courts have jurisdiction over which final agency actions.

A few commenters suggested that if the EPA is concerned about local court decisions impacting national policy, the EPA should have those cases transferred to the D.C. Circuit for decision. The commenters stated that CAA § 307(b)(1) requires final actions “of nationwide scope or effect” be heard by the D.C. Circuit. The commenters contended that this provision, in combination with the existing Regional Consistency regulations, is enough to ensure fairness and uniformity in the application of policies nationwide.

One commenter stated that intercircuit nonacquiescence is in conflict with CAA § 307(b)(1), through which Congress tried to prevent the very intercircuit conflicts that the proposed revisions will allow. The commenter noted that if locally and regionally applicable actions with nationwide scope and effect are properly heard by the D.C. Circuit, there should be relatively few situations where a circuit court addresses an issue that can create inconsistency in the interpretation or implementation of CAA requirements. Another commenter contended that CAA § 307(b) does not stand for the proposition that the EPA can ignore decisions of non-D.C. Circuit courts simply because they arose in the context of a permitting decision. In fact, they maintain, CAA § 301 stands for the opposite proposition.

The EPA agrees that CAA § 307(b)(1) requires final actions “of nationwide scope or effect” be heard by the D.C. Circuit. This may include regional rulemaking that the EPA has identified and designated as having national scope and effect. However, when the EPA is applying regulations of nationwide scope to a particular circumstance, another appropriate circuit court should hear that decision of local or regional impact.

We agree with commenters that if the D.C. Circuit were the only court to rule on the reasonableness of the EPA's interpretation of its national regulations, there would be very little need for intercircuit nonacquiescence because the only action being reviewed by the court would be the EPA's application of that interpretation to the facts of the case. However, sometimes a court other than the D.C. Circuit (or U.S. Supreme Court) renders an adverse decision that rejects the EPA's interpretation of nationally applicable regulations in a manner that could be argued to have general rather than merely case-specific implications. This can happen, for example, where the court does not merely find that the facts do not support the EPA's application of national policy, but instead finds fault with the national policy itself. The Sixth Circuit decision in Summit Petroleum Corp. v. U.S. EPA, 690 F3d 733 (6th Cir. 2012) is the quintessential example of a final action of local or regional application; in the context of reviewing that local action, the Sixth Circuit rejected the EPA's longstanding interpretation of the applicable national regulations. Revisions to the Regional Consistency regulations will minimize, not exacerbate, the disruption to the smooth implementation of the CAA caused by locally or regionally applicable circuit court decisions by limiting their applicability to those areas covered by the circuit court, and leaving national policy in place in the rest of the country. Parties that agree with the decision of the regional circuit and believe it should be followed nationally are, of course, free to advocate that position to the EPA (and, if necessary, reviewing courts) in specific cases arising in other circuits. Revisions merely make clear that EPA will not automatically be bound to follow locally or regionally applicable circuit court decisions in cases arising in other circuits.

It would be contrary to the division of responsibility among the circuit courts that Congress established in CAA § 307(b) for the EPA to eliminate their review by moving any case that could potentially affect national policy to the D.C. Circuit. Such an approach also would disrupt the timeline for review created by the CAA. Challenges to nationally applicable regulations must be filed within 60 days of the regulations being published in the Federal Register. Treating any challenge to each and every application of those regulations as challenges to the underlying regulations that must be heard by the D.C. Circuit would either render those challenges untimely (to the extent they occur outside the 60-day window) and thus require their dismissal, or render the 60-day window superfluous by allowing challenges to the regulations any time they are applied. See, e.g., Sierra Club de Puerto Rico, et al. v. EPA, 815 F.3d 22 (D.C. Cir. 2016) (dismissing a challenge to a 1980 regulation as untimely because the purported after-arising ground involved the mere application of that old regulation). Neither result is consistent with the judicial review provisions established in CAA § 307(d). In fact, given the clear language of § 307(b), it is not clear whether a court would transfer a challenge to a decision of local or regional nature to the D.C. Circuit. See, e.g., Dalton Trucking, Inc. v. United States EPA, 808 F.3d 875 (D.C. Cir. 2015) (finding that the D.C. Circuit was not the proper court to hear a challenge to a preemption waiver for California because the waiver decision did not have national applicability, nor did the EPA make or publish a finding that the decision was based on a determination of nationwide scope or effect). Finally, sometimes adverse decisions arise in the context of enforcement cases, which must be heard in particular district courts, and then any appeal must be heard by the circuit court with jurisdiction over that district court. Thus, the EPA simply cannot ensure that all court decisions potentially involving review of national policy are heard in the D.C. Circuit.

Finally, the EPA is not ignoring decisions of other circuits by revising the Regional Consistency regulations. Rather, these revisions help to ensure that we are clearly following the applicable law of the circuit in the geographic areas covered by the decision. But the EPA also is respecting the judicial review provisions of the CAA by limiting decisions reviewing locally or regionally applicable actions to those locations and regions covered by the circuit court.

The revisions also are consistent with CAA § 301. As described in the proposed rule, § 301(a)(2) requires the EPA Administrator to develop regulations to “assure fairness and uniformity” of agency actions. Notably, there is nothing in the text of CAA § 301(a)(2) or its limited legislative history that suggests Congress intended to either upset the balance Congress struck when establishing judicial review provisions in CAA § 307, or disrupt the general principles of common law that have allowed for the percolation of issues up through the various circuit courts, as discussed previously. Section 301(a)(2) of the Act does not specifically address how the agency should respond to adverse court decisions.

In addition, the text of CAA § 301(a)(2)(A) necessitates a balance between uniformity and fairness; however, promoting either one of these attributes does not always guarantee maximizing the other attribute in all circumstances. These revisions would ensure the EPA has the flexibility to maintain that balance, as appropriate.

Several commenters maintained that the EPA's proposed amendments to the Regional Consistency regulations are inconsistent with the clear and unambiguous language of CAA § 301(a)(2). The commenters stated that this provision requires the EPA to promulgate rules establishing “general applicable procedures and policies for Regional officers and employees . . . to follow” that are designed to “assure fairness and uniformity in the criteria, procedures, and policies” applied by the EPA Regional offices. The commenters contended that the EPA's proposed rule codifies an impermissible exception to uniformity in the form of intercircuit nonacquiescence.

A few commenters pointed to the legislative history associated with the passage of CAA § 301(a)(2) and noted that Congress clearly intended there to be national consistency in implementing core CAA programs. One commenter noted that Congress's directive in CAA § 301 was particularly critical in the prevention of significant deterioration (PSD) and new source review (NSR) permitting programs, as well as other national standards (e.g., New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants).

A few commenters also stated that even if CAA § 301 were ambiguous, the EPA's proposed amendments to the Regional Consistency regulations are unreasonable. The commenters noted that the D.C. Circuit vacated the EPA's Summit memorandum based on the language in the EPA regulations, which essentially is exactly the same as the statutory language and mandate requiring fairness and uniformity. Thus, the commenters concluded, the court has already found that the statutory language establishes a national uniformity mandate. One commenter additionally noted that the fact that court decisions are not expressly addressed by CAA § 301(a)(2) does not create ambiguity; the statute requires the EPA to maintain consistency.

Two commenters noted that the D.C. Circuit has recognized the call for uniformity as well in Kennecott Corp. v. EPA, 684 F.2d 1007 (D.C. Cir. 1982). One commenter stated that the EPA's reliance on Air Pollution Control Dist. v. EPA, 739 F.2d 1071 (6th Cir. 1984) in the proposal is misplaced because the case involved a different issue. The commenter maintained that the case does not support the EPA in ignoring the plain language of CAA § 301(a)(2) to promote “fairness and uniformity.” The commenter noted that the court in Air Pollution Control Dist. expressed a “strong preference to achieve an interpretation of the Act which is consistent among the several circuits.” Id. at 1094.

One commenter stated that the EPA's proposal is inconsistent with CAA § 301(a)(1), which provides that the Administrator may delegate authority when it is “necessary or expedient.” The commenter stated that if the Administrator delegates her authority to Regional Administrators who make inconsistent decisions, the delegation would not be expedient and therefore would violate CAA § 301(a)(1). The commenter further maintained that the EPA incorrectly stated in the proposal notice that the current Regional Consistency regulations that require regional officials to “seek concurrence” from Headquarters could result in inconsistent policies among Regional offices. Proposal at 50258. According to this commenter, this existing mechanism ensures consistency and does not condone variation between Regional offices.

Two commenters argued that the EPA's proposal to incorporate intercircuit nonacquiescence into the Regional Consistency regulations creates “irrationality” in the rulemaking process. The commenters argue that by allowing her delegatees (e.g., Regional Administrators) to act in an inconsistent manner is tantamount to the Administrator acting inconsistently, which is impermissible.

The EPA disagrees with the commenters who state that the revision to the Regional Consistency regulations is inconsistent with CAA § 301(a)(2). On its face, CAA § 301(a)(2) does not impose a standalone requirement to attain uniformity. While CAA § 301(a)(2)(C) directs the EPA to create mechanisms for identifying and standardizing various criteria, there is nothing to suggest that such standardization requires exact duplication by all EPA Regions in all circumstances, including Regional office responses to court decisions.

As noted earlier, CAA § 301(a)(2) does not specifically discuss whether the fairness and uniformity objectives must be applied to all court decisions. Instead, the provision requires the EPA to establish procedures that apply to its Regional office officials and employees, but it does not address whether or how the EPA should address judicial decisions in those procedures. Congress also did not include language that would expressly prohibit the EPA from promulgating regulations that accommodate intercircuit nonacquiescence. To the extent that Congress prioritized judicially-created uniformity, this was expressed in CAA § 307(b)(1)—which allows for regional divergence among circuit courts—not in CAA § 301(a)(2)(A).

The EPA disagrees with commenters who claim that the amendments to the Regional Consistency regulations violate CAA § 301(a)(1). This provision provides authority to the Administrator to delegate her powers and duties to any EPA officer or employee as “[s]he may deem necessary or expedient.” This delegation is “expedient” if it is “suitable for achieving a particular end in a given circumstance” or “characterized by concern with what is opportune.” Expedient, Merriam-Webster Dictionary (2015). Given the immense quantity and breadth of tasks assigned to the Administrator through the CAA and other statutes the EPA is charged with administering, delegation of the Administrator's authorities is both necessary and expedient in many circumstances to efficiently protect the environment and public health. Further, in amending the Regional Consistency regulations, the EPA is introducing only a narrow procedural exception to deal with federal court decisions adverse to EPA regarding locally or regionally applicable actions that may affect consistent application of national programs, policy, and guidance. The EPA does not agree that it is “irrational” for the agency to act differently in different regional actions when that difference is necessitated by an adverse local or regional court decision, whether the action is taken by the EPA Regional Administrators or by the Administrator herself.

As commenters admit, in NEDACAP, the D.C. Circuit explicitly did not address whether the CAA allows the EPA to adopt different standards in different circuits. NEDACAP at 1011. While the NEDACAP decision relied heavily on the general policy statements contained in 40 CFR 56.3 of the existing regulations—which broadly endorse the fair and uniform application of criteria, policy, and procedures by EPA Regional office employees—nothing in those general statements or any other provisions of the regulations mandates that the EPA adopt nationwide the interpretation of the court that first addresses a legal matter. The lack of such a mandate supports the focused revisions in this rulemaking that are a natural extension of the agency's existing regulations.

As commenters noted, the D.C. Circuit cited to CAA § 301(a)(2) in Kennecott. 684 at 1014, fn. 18. However, this statutory provision was not central to the case, so the court's mention of the provision was dicta. The D.C. Circuit described the EPA's ability to prescribe in advance criteria that states must use in making a specific type of determination. The EPA's ability to require states to follow certain rules is not in question in this rulemaking. The court also stated that establishing criteria to implement a particular CAA program “on an ad hoc incremental basis” would not amount to “fairness and uniformity” described in CAA § 301(a)(2). The EPA is not attempting to create ad hoc rules on how to implement programs. Rather, in taking this final action, the EPA is creating a clear and uniform presumptive approach and standard agency process to follow in light of adverse local and regional court decisions. This is the opposite of an ad hoc approach.

As the EPA noted in the proposal notice, Air Pollution Control Dist. rejected the claim that CAA § 301(a)(2) establishes a substantive standard that requires similar or uniform emission limitations for all sources. 739 F.2d 1071, 1085 (6th Cir. 1984). Although that case addressed a different issue than the content of this rulemaking, specifically whether CAA § 301(a)(2) required the EPA to implement similar or uniform emission limitations for each source within a particular area, the decision does support the overall concept that CAA § 301(a)(2) does not impose a standalone requirement to attain uniformity.

Further, the EPA believes that the quote used by the petitioner in that case from page 1094 of the decision has been taken out of context. The court made a certain substantive ruling in Air Pollution Control District on an issue unrelated to this rulemaking. In making that decision, the court was seeking to keep its decision consistent with those of other circuit courts. A court's decision to make a holding consistent with other courts' prior decisions or to create a circuit split is outside the purview of this rulemaking and this agency. It may be a factor that weighs into how a court comes to a decision, but does not speak to how the agency should treat national policy in light of an adverse court decision with regional or local applicability, nor does it speak to the issue of whether it is appropriate for the EPA to create a narrow exception to the procedure established in the Regional Consistency regulations for adverse local and regional court decisions.

There is nothing in the limited legislative history of CAA § 301(a)(2) that counsels against the revision the EPA is making through this final action. The legislative history quoted by the commenter discusses one particular instance of regional inconsistency that, at least in part, motivated Congress to implement the regional consistency language of CAA § 301(a). This situation, which involved the use of different air quality models in different regions for the purpose of implementing the PSD permitting program, is far removed from the case of an adverse court decision of local or regional scope. Further, the legislative history surrounding passage of CAA § 307(b) indicates that Congress intended to advance the objective of even and consistent national application of certain EPA regulations that are national in scope. At the same time, Congress left the door open to intercircuit conflicts by granting jurisdiction over locally or regionally applicable “final actions” to the regionally-based courts of appeals. The EPA has found, and commenters have pointed to, nothing in the legislative history to suggest that at the same time, Congress intended for the Regional Consistency provisions to somehow upset this careful balance and require the EPA to apply a locally or regionally applicable decision in all EPA Regions in order to maintain consistency.

The revisions further the overall goal of consistency and clarity by specifically identifying the possibility of potential differing actions across the EPA Regions, especially where multiple courts have already addressed an issue in different ways, and standardizing a response that can be followed by all the EPA Regions, such that the EPA Regions only have to apply local and regional decisions issued by courts in those geographic areas over which the court has jurisdiction.

No commenter has explained in any detail why the NSR, NSPS or NESHAP programs are uniquely situated such that it would be inappropriate to finalize the narrow exception to the Regional Consistency regulations to deal with locally or regionally applicable federal court decisions. While some programs (such as NSR and NSPS) create national standards and others are administered through EPA-approved state implementation plans (SIPs), all portions of the CAA are federal law and apply nationwide. The explanation for the revisions provided in the proposal and final rule preambles apply equally to all criteria, procedures, and policies, and the commenter has failed to provide a reasoned explanation why certain programs should be considered differently. The EPA also notes that it is at times impossible to maintain complete consistency in the face of adverse court decisions. By revising the regulations, the EPA accommodates the possibility that a split in the circuits could preclude the EPA from complying with both court decisions at once, as illustrated by the following example outlined in the proposal notice. In a case involving a permit issued in New York, the Second Circuit upholds the EPA's longstanding position and, in doing so, confirms that the EPA's interpretation is compelled by the Act under Step One of Chevron. As a result, the EPA continues to apply its longstanding interpretation, consistent with the Second Circuit's decision, in a permit issued in Alabama, an Eleventh Circuit state. In an appeal of that permit, however, the Eleventh Circuit holds that not only is the EPA's interpretation not compelled by the CAA, it is prohibited by the CAA. There are now two court decisions with conflicting Chevron Step One holdings—how could the EPA apply both of those decisions uniformly across the country? While the U.S. Supreme Court could review the issue, it might not. And even if the U.S. Supreme Court eventually resolved the conflict, there could be a multi-year period during which both decisions would remain applicable case law. See, e.g., discussion of Duke in Section 4.b.(2) of this document. This revision acknowledges and addresses those instances in which the EPA may not be able to comply with two, conflicting decisions at the same time.

Specifically accommodating intercircuit nonacquiescence in the Regional Consistency regulations also fosters fairness and predictability in the implementation of the CAA overall. As discussed earlier, the revisions ensure that national policy continues to apply unless there is an affirmative nationwide and deliberate change in the EPA's rules or policies, or an adverse court decision applies only in those states/areas within the jurisdiction of that court, with the exception of the D.C. Circuit court reviewing final agency actions of national applicability. Under the revised Regional Consistency regulations, a source subject to the CAA needs to know and follow only the law in the circuit where it is located, and the law of the D.C. Circuit Court and the U.S. Supreme Court. It would not be required to follow every CAA case in every court across the country to ensure compliance with the Act. While a source remains free to advocate for a change in the agency's national policy based on the results of a regional circuit court decision, unless and until the agency agrees to make such a change, the national policy will continue to apply except in the circuit where the adverse decision was issued.

A few commenters stated that the EPA's proposal, if finalized, would harm businesses due to different regulatory requirements applying to different facilities based on their location. For example, industry argues it will face uneven application and enforcement of CAA requirements, and incur increased compliance costs as they try to address regulatory ambiguity and confusion. One commenter stated that the proposed revisions would not ensure “fairness” as required in CAA § 301(a)(2). One commenter argued that the proposed revisions will have a chilling effect on new projects or improvements. One commenter noted that limiting the regulatory amendments to local or regional court decisions does not help because many of these decisions actually have nationwide impact.

One commenter cautioned that finalization of the proposed amendments to the Regional Consistency regulations will lead to increased litigation over venue, since decisions by the D.C. Circuit will apply nationwide, while decisions of district courts and other circuit courts would not be required to apply nationwide. Multiple commenters further noted that the rule change may also lead to additional litigation in multiple circuits to expand the impact of a single regional or local court decision. The commenters believe this will lead to greater burdens on litigants and strains on judicial resources.

One commenter stated that a lack of national uniformity would create confusion and implementation issues given that the geographic boundaries of the EPA's Regional offices do not match the boundaries of the federal circuit courts and that a single EPA Region may have to apply two different standards based on court decisions and their jurisdictions.

The EPA believes in the overall importance of uniformity and fairness in the application of criteria, procedures, and policies across the various EPA regions in most instances. As the EPA explained when the Regional Consistency regulations were first finalized, the “intended effect” of these regulations was “to assure fair and consistent application of rules, regulations and policy throughout the country by assuring that the action of each individual EPA Regional office is consistent with one another and national policy” (45 FR 85400). These revisions merely identify a specific circumstance under which an EPA Regional office no longer needs to seek Headquarters concurrence to diverge from national policy, and confirms that national policy otherwise continues to apply.

CAA § 301(a)(2) focuses on promoting fairness and uniformity. The EPA believes that predictability is an important element of fairness and also a worthwhile objective to achieve in carrying out its mission. The changes made to the Regional Consistency regulations foster predictability by ensuring that, unless there is an affirmative nationwide and deliberate change in the EPA's rules or policies, lower court decisions would apply only in those areas within the jurisdiction of the lower court, with the exception of the D.C. Circuit Court reviewing final agency actions of national applicability, consistent with CAA § 307(b)(1). The EPA may choose to initiate a change in national policy at any time, including in light of an adverse court decision, but the agency is bound to follow appropriate procedures in order to do so.

If the revisions to the Regional Consistency regulations had already been in place at the time of the Summit decision, a memorandum from EPA Headquarters like the one challenged in the NEDACAP decision would not have been necessary because EPA Regions, states, and other potentially affected entities would have had certainty and predictability regarding the application of such a judicial decision—they would have known that this type of permit-specific, local and regional decision would only apply in the areas under the jurisdiction of the Sixth Circuit (unless and until the agency expressly decides to make a change to its national policy after consideration of the decision). Accordingly, it would have been clear to everyone that the EPA Regions would not be bound to apply the findings of the Summit decision in states outside the Sixth Circuit, and could continue to apply the longstanding practice that had not been successfully challenged in other federal circuit courts in their regions or decided nationally by the D.C. Circuit or U.S. Supreme Court.

The EPA acknowledges that under the revisions finalized, some facilities may be subject to different regulatory requirements based on their location. Some difference in governing rules is inherent in our federal judiciary system where district and circuit courts are limited to a definitive jurisdiction. The federal judicial system was designed to allow numerous, and sometimes conflicting, decisions until such time as the U.S. Supreme Court rules on an issue. The structure of the federal judicial system also sometimes results in increased litigation, as issues are considered by multiple courts. As noted previously, this rule simply changes the internal procedure followed by the agency in light of an adverse court decision; thus, these revisions, which are consistent with the federal judicial system, will not singlehandedly lead to increased litigation. One commenter noted that following this rulemaking, litigants may wish to challenge the venue of litigation more often to try to ensure cases are heard by the D.C. Circuit so that judicial outcomes apply nationwide. The EPA believes it is appropriate for venue to be challenged if the litigation is not brought in the appropriate court according to CAA § 307(b)(1). Under the CAA specifically, the drafting of CAA § 307(b) indicates that Congress intended to leave the door open to intercircuit conflicts by granting jurisdiction over locally or regionally applicable “final actions” to the regionally-based courts of appeals.

Further, sometimes court decisions reviewing a regulation or statute are reversed on appeal. In other cases, a court decision may contain a ruling that arguably calls into question a national rule in the context of a source-specific action, which is inconsistent with CAA § 307(b)(1), as explained in the proposal notice. When either outcome occurs, intercircuit nonacquiescence allows the EPA to limit the impact of the court's ruling while it undertakes other actions. For example, as outlined in the proposal notice, in Duke, 549 U.S. 561 (2007), the U.S. Supreme Court reversed the Fourth Circuit's implicit invalidation of the EPA's regulations in the context of an enforcement action. In that case, the U.S. Supreme Court found that the court of appeals had been too rigid in its insistence that the EPA interpret the term “modification” in its PSD regulations in the same way that the agency interpreted the term under the NSPS program. Id. at 572-577. While it is true that the U.S. Supreme Court eventually reversed the lower court, there was a 2-year period during which the Fourth Circuit's decision remained in place. Under the commenter's proposed approach, the EPA arguably would have been required to follow that later-reversed Fourth Circuit interpretation of its regulations nationwide during that 2-year period, even though the interpretation “read those PSD regulations in a way that seems to [the Supreme Court] too far a stretch for the language used.” Id. at 577.

The EPA disagrees that the amendments made to the Regional Consistency regulations are poor public policy. It is generally acceptable to apply a circuit court or District Court decision only within the jurisdiction of the court. A standard that specifically allows for intercircuit nonacquiescence for all CAA decisions other than those issued by the D.C. Circuit Court in response to challenges of nationwide actions would provide a uniform standard for the EPA's application of court decisions that could be anticipated by those who implement the regulations and the regulated community.

The EPA acknowledges that the EPA Regional office boundaries do not align with the boundaries of circuit courts. However, the EPA Regional offices and Headquarters will endeavor to make clear the states, tribes, or local jurisdictions that are impacted by an adverse court decision. The EPA notes that, consistent with past practice, in certain instances the EPA Regions are already applying different policies across their states based on prior court decisions See, e.g., discussion of follow on to Sierra Club decision in Section 5.b.(2) of this document.

In the proposed rule, we noted that the Regional Consistency regulations already allowed for some variation between the EPA Regional offices. Specifically, the original version of 40 CFR 56.5(b) provided that regional officials should “seek concurrence” from the EPA Headquarters with respect to any interpretations of the Act, rule, regulation, or guidance that “may result in inconsistent application among the Regional offices.” Thus, the Regional Consistency regulations have always contained a mechanism by which an EPA Regional office could diverge from national policy if doing so was required by an adverse court decision (i.e., by seeking Headquarters concurrence). The revisions simplify the process by establishing the presumption that national policy will continue to apply nationwide, but that an EPA Regional office impacted by an adverse court decision could diverge from that national policy without Headquarters concurrence to the extent required by the adverse court decision. In fact, the revisions further the overall goals of the existing Regional Consistency regulations by specifically identifying the possibility of potential differing actions across the EPA regions, especially where multiple courts have already addressed an issue in different ways, and standardizing a response that can be followed by all the regions, such that EPA regions only have to apply local and regional decisions issued by courts in those areas over which the court has jurisdiction.

Nonetheless, as noted previously, the revisions do not hinder the EPA's ability to respond to an adverse court decision by revising a national policy or interpretation, following appropriate procedures, either on the agency's own initiative or in response to a request from a regulated entity or other interested party. The EPA recognizes that national policy can be influenced by insights and reasoning from judicial decisions and these revisions are not an indication that the agency will ignore persuasive judicial opinions issued in cases involving “locally or regionally applicable” actions. Such opinions may address issues of nationwide importance and could, in appropriate circumstances, lead the agency to adopt new national policy.

Some commenters stated that there would be no predictability under the EPA's proposal. One commenter expressed concern that the EPA Regional offices not covered by an adverse decision could choose to follow the adverse decision versus national policy. Another commenter also noted that the EPA's goal of promoting predictability is irrelevant because CAA § 301(a)(2) requires consistency, not predictability.

A couple of commenters stated that the EPA's proposed revision of the Regional Consistency regulations goes against 35 plus years of implementing the existing regulations. The commenters also argued that it is inconsistent with the position the EPA has taken in various rulemakings and historic practice, citing statements by a former EPA General Counsel.

Numerous commenters stated that the proposed amendments to the Regional Consistency regulations would allow the EPA too much discretion in deciding whether certain court decisions will apply on a national scale. They stated that there would be no guarantee that further judicial review would resolve conflicting decisions, citing to currently conflicting decisions on application of the statute of limitations to construction permitting as an example. Commenters expressed concern that this could lead to the EPA applying arbitrary and unspecified factors to determine when judicial decisions will be applied nationally. Several commenters suggested that the EPA should establish criteria it would use to determine when it will not change its national policy and when it will in the face of an adverse court decision. Commenters recommended that the EPA withdraw the rule, or, if it proceeds, provide clear criteria to identify when intercircuit nonacquiescence will be applied.

One commenter recommended that the Regional Consistency regulations only follow intercircuit nonacquiescence (1) Until three circuit courts have resolved the legal issue; (2) in circumstances of significant importance and impact on protection of human health and the environment; and (3) when documented in a written memorandum or directive signed by the Assistant Administrator for the Office of Air with concurrence of the General Counsel. Another commenter recommended that the EPA revise the Regional Consistency regulations to state that the agency will revisit a national policy whenever a court determines that it is arbitrary, capricious or otherwise unlawful. Further, the commenter offered that in such circumstances the EPA should consider whether to issue guidance clarifying what the EPA's policy will be going forward and undertake a rulemaking to effectuate that agency policy.

One commenter suggested that if the EPA does finalize the proposed amendments to the Regional Consistency regulations, the EPA should retain requirements “that (1) EPA Headquarters issue or revise mechanisms to address federal court decisions of local or regional applicability, see 40 CFR 56.4, and (2) the EPA Regional offices seek concurrence from the EPA Headquarters to act inconsistently with national EPA policy or interpretation if such action is required by a federal court decision of local or regional applicability. See CFR 56.5.” The commenter indicated these mechanisms promote certainty, predictability, and fairness for regulated entities. Another commenter suggested that the EPA Regional offices should still be required to seek the Office of General Counsel's concurrence when they believe they are bound by an adverse court decision which requires them to deviate from national policy. A separate commenter expressed concern that the proposed revisions would allow a region to deviate from national policy without Headquarters concurrence that such deviation was required by a court decision.

A couple of commenters argued that the EPA should allow notice and comment on agency determinations that it would depart from these final Regional Consistency regulations and apply certain judicial decisions more broadly on a case-by-case basis. One commenter recommended that “regional consistency determination[s]” be published in the Federal Register. Another commenter stated that the EPA should define “fairness” and “uniformity” in the regulations.

The EPA disagrees with the commenters' characterization of this action. The final revisions authorize an EPA region to diverge from national policy only to the extent that the EPA Region must do so in order to act consistently with a decision issued by a federal court that has direct jurisdiction over the EPA Region's action. The EPA regions outside of that court's jurisdiction would still be required to follow national policy or seek Headquarters concurrence to deviate from that policy. This is the same procedure established under the original Regional Consistency regulations.

The EPA further disagrees with commenters' statement that these final revisions go against the agency's past practice. Following the Summit decision, consistent with the Regional Consistency regulations, EPA Regions 4 and 5 could have sought Headquarters concurrence to deviate from national policy in order to follow the directive of the Sixth Circuit. In fact, EPA Region 4 did utilize this provision following the Sixth Circuit decision in Sierra Club v. EPA, 781 F.3d 299 (6th Cir. 2015), cert. denied 2016 U.S. LEXIS 2221 (March 28, 2016), which held that the EPA was not permitted to approve a redesignation request without first approving reasonably available control measures into the state SIPs. This decision went against the EPA's longstanding interpretation that where an area is attaining the NAAQS, these measures that are designed to bring areas into attainment are “inapplicable” under CAA § 107(d)(3)(E)(ii) for purposes of evaluating a redesignation. Following that decision, officials in EPA Region 4 sought and received concurrence from EPA Headquarters to follow the requirements of the Sierra Club decision, which are inconsistent with the EPA's national policy, in states falling within the jurisdiction of the Sixth Circuit. See 80 FR 56418 (September 18, 2015).6 If the EPA were to adopt the commenters' position, the agency would have to apply the decision of the Sixth Circuit nationwide.

Thus, the Regional Consistency regulations have never required absolute uniformity between the EPA Regional offices. Rather, the Regional Consistency regulations have always acknowledged that certain EPA Regions may in some instances act differently from others, and these final revisions simply identify and authorize differences in a specific limited circumstance—when necessitated by a federal court decision reviewing an action of local or regional applicability. Accordingly, the EPA does not view finalization of this rule as a significant shift in the practical outcomes. Rather, the EPA is changing the internal procedure followed by the agency in light of an adverse court decision.

A couple commenters claimed that the revisions to the Regional Consistency regulations are inconsistent with statements made by a former EPA General Counsel. These comments of a former EPA General Counsel were made in the context of a discussion of the intracircuit nonacquiescence practices of other agencies, which is different from intercircuit nonacquiescence as explained in Section III.B.1 of this document. See S. Estreicher & R. Revesz, Nonacquiescence by Federal Administrative Agencies, 98 Yale L. J. 679, 717 (February 1989) (surveying approaches of other federal agencies after describing the intracircuit nonacquiescence policies of the Social Security Administration and National Labor Relations Board).

The EPA considered the suggestions of several commenters to add regulatory text defining the parameters under which the agency would be required to re-evaluate its national policy following adverse court decisions. In response, we note that the EPA carefully reviews each adverse court decision. The types of factors advocated by the commenters (e.g., the reasoning for the adverse court decision, the number of adverse court decisions) generally are factors considered by the EPA as it develops its response to any given adverse court decision, including any reconsideration of the relevant national policy or interpretation. This case-by-case approach is best because it allows the EPA to consider the individual merits of each decision and the appropriate course of action rather than apply a rigid formula. Nonetheless, it would be counterproductive to codify any specific parameters in regulatory text that must be applied in any and all circumstances.

We also are not requiring that a Regional office obtain Headquarters concurrence regarding whether an adverse court decision requires that Regional office to deviate from otherwise applicable national policy. A key purpose of the revisions is to establish the presumption that national policy remains national policy, and thus the Regional offices are already required to follow national policy to the extent allowed by an adverse court decision applicable to the Regional office's actions. Of course a Regional office is always free to discuss the scope of a court decision with Headquarters, but revisions do not require a Regional office seek concurrence before acting consistent with an adverse court decision applicable to the action being undertaken by the Regional office.

Contrary to the concerns of some commenters, the final revisions will not allow the EPA to act arbitrarily in determining how to respond to an adverse court decision. Nothing in the final revisions alters the requirement that the EPA act in a reasonable, non-arbitrary manner at all times. Moreover, the final revisions already provide clear criteria regarding when the EPA will apply intercircuit nonacquiescence by establishing the presumption that national policy will not change in response to any given adverse decision.7 In other words, national policy will remain unchanged until such time as the agency changes it through the appropriate method. That presumption does not provide the EPA unlimited discretion, but does retain the discretion to determine national policy granted the EPA by Congress through the CAA.

The public is always free to petition the EPA to change regulations and national policy if it believes that the agency is inappropriately maintaining national policy in the face of numerous adverse court decisions. If a party believes that the EPA's position is no longer viable, it may petition the agency to change that position, and the party may then seek to challenge the EPA's final response to that petition if the party believes the EPA's final response is unreasonable, so long as the party meets all the usual statutory and jurisprudential requirements for such a challenge. For rules of national applicability, such challenges would be, appropriately, in the D.C. Circuit. See, e.g., Oljato, infra. Thus, the existing system already contains sufficient safeguards to ensure that the EPA continues to act in a reasonable manner, and additional regulatory text is not necessary.

Thus, as noted earlier, the EPA is not adding regulatory text establishing specific parameters or criteria that would govern how the agency would act in light of adverse court decisions. Nor is the EPA establishing new procedures that would apply if and when the EPA does reconsider national policy. As always, if the EPA does revisit national policy, it will follow the applicable procedures. For example, if the agency is changing regulatory text, it will undertake the appropriate notice and comment process. If, however, the EPA is merely issuing an interpretive rule without changing the regulations themselves, then consistent with the Administrative Procedure Act and U.S. Supreme Court case law, the EPA is not bound to follow a notice and comment process. 5 U.S.C. 553(b)(3)(A); Perez v. Mortgage Bankers Ass'n, 135 S. Ct. 1199 (2015).

The EPA received other miscellaneous comments that do not fall under the previous discussions, which are responded to in Sections 6.a and b.

Several commenters stated that the EPA should withdraw the proposal and leave the Regional Consistency regulations in place as currently written. A couple of commenters noted that the proposed amendments to the Regional Consistency regulations are not necessary because the EPA is under no obligation to undertake the rulemaking action. Commenters stated that while the EPA purported in the proposal notice to undertake the rulemaking in response to the NEDACAP decision, that court did not in any way require the EPA to undertake this rulemaking. In fact, the court applied the regulations when vacating the EPA's Summit memorandum.

Several commenters stated that the court's suggestion in NEDACAP that the EPA could amend the Regional Consistency regulations is not equivalent to that court's endorsement of such an approach under CAA § 301(a)(2). The commenters note that the D.C. Circuit expressly did not rule on “whether the [Clean Air Act] allows the EPA to adopt different standards in different circuits” in the NEDACAP opinion. 752 F.3d at 1011. Further, one commenter detailed that in NEDACAP, the D.C. Circuit held that the “fair and uniform” language of the existing Regional Consistency regulations, which is parallel to the language in CAA § 301(a)(2), establishes a national regulatory uniformity requirement.

One commenter noted that the EPA has other ways to respond to the court's decision in NEDACAP. In an example, the commenter cited the EPA's response to conflicting decisions regarding the benzene NESHAP and “federal enforceability.” The commenters also stated that if the EPA stopped “continuously seeking to expand the reach of its regulations through such guidance” the agency could avoid adverse decisions like that in the Sixth Circuit regarding the Summit permitting decision.

The EPA has not taken the position that it is required by the D.C. Circuit's opinion in NEDCAP to undertake revisions to the Regional Consistency regulations. We agree that the EPA has discretion in deciding whether or not to undertake the revisions being finalized. The EPA also recognizes that the court's suggestion that the EPA could revise the Regional Consistency regulations is not necessarily a judicial endorsement of the specific revisions being finalized, although it is unlikely that the court would make such a suggestion if any changes to the regulations to address intercircuit nonacquiescence would be in conflict with the statute.

Contrary to statements made by commenters, the EPA does not “continuously seek[ ] to expand the reach of its regulations through [ ] guidance.” Rather, the EPA issues guidance in an effort to better inform the regulated community and the public regarding the requirements of CAA regulations.

For the reasons set forth here and in the proposed rule, these revisions to the Regional Consistency regulations are an effective way to address the implications of adverse court decisions rendered by courts reviewing actions of local or regional applicability. While the EPA does have other options available to it, the EPA has determined that these revisions to the Regional Consistency regulations most effectively address the issue presented by an adverse court decision involving an action or local or regional applicability.8 The revisions also accommodate the EPA's proper and longstanding application of the doctrine of intercircuit nonacquiescence in future cases, while eliminating the need to undertake lengthy, narrowly focused rulemakings or seek review of all lower courts' adverse decisions by the U.S. Supreme Court.

One commenter contended that the EPA failed to acknowledge the difference between an EPA action involving interpretation of a national regulation applied to a particular facility and an EPA action addressing a SIP provision. In the context of SIP provisions, the commenter stated that, “to the extent not prohibited by the CAA, the EPA should (and must) allow inconsistencies in particular SIP provisions as between states.”

Another commenter supported the EPA's proposed addition to CAA § 56.5(b) insofar as it will ensure that the EPA Regional offices not subject to a court decision will continue to act consistently with existing national policy. However, the commenter believes that the proposed revision to CAA § 56.5(b) does not clearly accomplish this. The commenter contended that the existing and proposed regulatory text should be harmonized to make clear that, after an adverse court decision issued by a court reviewing a locally or regionally applicable action, continued application of national policy by the EPA Regional offices that are not subject to that court's jurisdiction does not require concurrence from EPA Headquarters, notwithstanding any inconsistency with the actions taken by the EPA Region(s) bound by the court's decision.

The EPA agrees with the commenter that states are accorded great discretion under CAA § 110 in determining how to meet CAA requirements in SIPs. However, states are obligated to develop SIP provisions that meet fundamental CAA requirements. The EPA has the responsibility to review SIP provisions developed by states to ensure that they in fact meet fundamental CAA requirements. The Regional Consistency regulations generally establish certain mechanisms with the goal of “identifying, preventing, and resolving regional inconsistencies” (45 FR 85400). For the EPA Headquarters office employees, the regulations do this by targeting particular aspects of the Act that have the potential to present consistency problems—including any rule or regulation proposed or promulgated which sets forth requirements for the preparation, adoption, and submittal of state implementation plans.

We concur with the comment that the EPA Regional offices not covered by an adverse court decision should continue to follow existing national policy. We looked at the proposed revisions to 40 CFR 56.5(b), as well as the revised language provided by the commenters. We agree that the revision to 40 CFR 56.5(b) suggested by the commenter more clearly expresses that the exception to seeking Headquarters concurrence applies only to the EPA regions that must diverge from agency policy due to an adverse court decision with jurisdiction over the EPA region's actions. We have thus changed the regulatory text accordingly.

This action finalizes a rule revision that provides procedural direction to the EPA Regions and Headquarters offices in implementing court decisions of a limited scope (i.e., those having local or regional applicability). The EPA did not conduct an environmental analysis for this rule because this rule will not directly affect the air emissions of particular sources. Because this rule will not directly affect the air emissions of particular sources, it does not affect the level of protection provided to human health or the environment. Therefore, this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations.

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

This action does not impose any new information collection burden. The final rule will not create any new requirements for regulated entities, but rather provides procedural direction to the EPA Regions and Headquarters offices in implementing national programs potentially affected by adverse court decisions of a limited scope (i.e., those having local or regional applicability).

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if a rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This final rule will not impose any requirements directly on small entities. The EPA and any state/local governments implementing delegated EPA programs are the only entities affected directly by this final rule. Other types of small entities are also not directly subject to the requirements of this rule.

This action does not contain any unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. This final rule revises regulations that apply to the EPA, and any delegated state/local governments, only, and would not, therefore, affect the relationship between the national government and the states or the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175. This final rule only provides procedural direction to EPA Regions and Headquarters offices in implementing court decisions of a limited scope (i.e., those having local or regional applicability). Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not directly involve an environmental health risk or safety risk.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

This action does not involve technical standards.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

The documentation for this decision is contained in Section IV of this document titled, “Environmental Justice Considerations.”

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

Under CAA § 307(b)(1), petitions for judicial review of any nationally applicable regulation, or any action the Administrator “finds and publishes” as based on a determination of nationwide scope or effect must be filed in the United States Court of Appeals for the District of Columbia Circuit within 60 days of the date the promulgation, approval, or action appears in the Federal Register. This action is nationally applicable, as it revises the rules governing procedures regarding regional consistency in 40 CFR part 56. As a result, petitions for review of this final action must be filed in the United States Court of Appeals for the District of Columbia Circuit by October 3, 2016. Filing a petition for reconsideration by the Administrator of this final action 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 must be filed, and shall not postpone the effectiveness of this action.

The statutory authority for this action is provided by section 301 of the CAA as amended (42 U.S.C. 7601).

For the reasons stated in the preamble, title 40, chapter I, part 56 of the Code of Federal Regulations is amended as follows:

Background information. On December 7, 2015 (80 FR 76152), the EPA finalized amendments to the Aerospace Manufacturing and Rework Facilities NESHAP based on our Risk and Technology Review. In this action, we are clarifying the intended compliance date for sources subject to the recently finalized handling and storage of waste requirements.

Organization of this document. The information in this preamble is organized as follows:

I. Background

The Affordable Care Act provided CMS with new tools and resources to combat fraud, waste, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP), including the authority to implement a temporary moratorium on provider enrollment in these programs. CMS uses quantitative and qualitative data to determine whether there is a need for a moratorium, such as reviewing provider and supplier saturation data for the area under consideration for a moratorium and whether such area has significantly higher than average billing per beneficiary or provider per beneficiary ratios. CMS first used its moratoria authority on July 30, 2013, to prevent enrollment of new home health agencies (HHAs) in the Chicago, Illinois and Miami, Florida areas, as well as Part B ground ambulance suppliers in the Houston, Texas area. CMS exercised this authority again on January 30, 2014, to extend the existing moratoria and expand them to include HHAs in the metropolitan areas of Fort Lauderdale, Florida; Detroit, Michigan; Houston, Texas; and Dallas, Texas, as well as Part B ground ambulance suppliers in Philadelphia, Pennsylvania and nearby New Jersey counties. The moratoria have since been extended at 6-month intervals and to date, remain in place in all of the locations previously noted.

Since implementation of the moratoria, CMS has been able to evaluate the moratoria and has identified several limitations. Because the current moratoria are geographically defined by county, they do not prohibit providers and suppliers from opening new locations or creating a new enrollment outside the moratorium area and moving it into a moratorium area. Moreover, CMS is unable to prevent existing providers and suppliers from outside of a moratoria area from servicing beneficiaries within that area. In fact, CMS has analyzed data showing that some providers and suppliers who are located several hundred miles outside of a moratorium area are billing for services provided to beneficiaries located within that moratorium area. The ability of providers and suppliers to circumvent the moratoria undermines the effectiveness of the moratoria in protecting the integrity of the Medicare, Medicaid, and CHIP programs.

In order to mitigate the vulnerabilities that have been observed in the current moratoria, CMS is expanding the moratoria on Medicare Part B, Medicaid, and CHIP non-emergency ambulance suppliers and Medicare, Medicaid, and CHIP HHA providers to statewide as announced elsewhere in this issue of the Federal Register.

CMS is implementing the “Provider Enrollment Moratoria Access Waiver Demonstration” (PEWD), as authorized by section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)), concurrently with the announcement of the statewide expansion of temporary moratoria on the enrollment of non-emergency ambulance suppliers and home health agencies in Medicare, Medicaid, and CHIP in six states elsewhere in this issue of the Federal Register. CMS is implementing this statewide expansion in order to address a high incidence of fraud in the moratoria areas without adversely affecting beneficiary access to care. This demonstration will permit a provider or supplier subject to the moratoria to submit a PEWD application that, if approved, will exempt the provider or supplier from the statewide moratorium in designated geographic areas. Additionally, it will implement a process for heightened review and investigations for such providers and suppliers enrolling pursuant to such waivers.

In order to qualify for a waiver of the moratoria restrictions, a provider or supplier must demonstrate that an access to care issue exists, and will be subject to heightened screening measures. If the provider or supplier receives a waiver, restrictions will be implemented on the provider's or supplier's service area to limit the provider or supplier to the area with access to care issues and prevent it from furnishing services in locations that are already oversaturated with that provider or supplier type. This restriction will be based on the saturation of providers or suppliers and the number of beneficiaries in the counties where the provider or supplier proposes to operate. Extensive evaluations of providers and suppliers seeking to enroll through this demonstration will be coupled with proactive reviews of submitted claims beginning within the first 60 days of enrollment, as well as increased investigations with referral to law enforcement as appropriate, for newly enrolled and existing providers.

Under the demonstration, claims submitted for services furnished outside of the provider's or supplier's approved service area will be denied and the provider or supplier may not bill beneficiaries for such services provided. This will limit the financial liability of Medicare, Medicaid, and CHIP beneficiaries and protect them from costs associated with claims submitted by providers and suppliers who are not eligible to provide services in that geographic location.

For the same reasons that we implementing this demonstration in Medicare, CMS will also implement the demonstration in Medicaid and CHIP, as authorized by section 402 of the Social Security Amendments of 1967.

The CMS Center for Program Integrity (CPI) will perform all PEWD application reviews and make the relevant access to care determinations.

CMS is currently engaged in the process to seek OMB approval of a PEWD application form under the Paperwork Reduction Act of 1995. Upon approval of this form, providers and suppliers should complete the form and submit it, with all required documentation, to the designated mailbox: [email protected]. Upon receipt of the application, required documentation, and payment of the application fee, CPI will review for completeness and, within 30 days, will respond with confirmation of receipt or in the case of an incomplete application, rejection. Application submission will require full disclosure of affiliations as outlined in the March 1, 2016 proposed rule (81 FR 10720) titled “Medicare, Medicaid, and Children's Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process” (hereinafter referred to as the March 1, 2016 proposed rule). Although this is a proposed rule, we are adopting the proposed procedures for disclosing affiliations for purposes of this demonstration. Should we receive more than one application for a particular geographical area, the applications will be prioritized by order of receipt. An application will not be considered received until it is complete, including fingerprints. A more detailed discussion regarding these requirements may be found later in this section of this document. Subsequently, CMS will have 90 days from initial receipt to review each application and communicate a decision to the provider or supplier.

Once a complete application is received, the primary determining factor for PEW approval under this demonstration, and the first step in application review, will be a determination regarding beneficiary access to care. This determination will be primarily based upon an evaluation of provider and supplier saturation, provider or supplier to beneficiary ratios, and claims data; this review will be supplemented with the access to care information that the provider or supplier has provided. As a requirement of the application, the provider or supplier will be required to submit detailed access to care information that demonstrates whether an access to care issue exists in the counties where the provider or supplier is attempting to enroll. In 2016, we publicly released moratoria-related saturation data. This data set, located at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-02-22.html, includes national and state, and county level, saturation data that identifies states that are currently impacted by moratorium. This data gives both states and the public detailed information relevant for an access to care justification. Additionally, we expect applicants to submit data to support that an access to care issue exists, which should not subject applicants to unnecessary burdens of performing extensive analyses. CMS will evaluate the provider- or supplier-generated information and compare it with statistical analysis data that is generated internally by CMS to determine whether an access to care issue exists in the identified area.

If we determine that a beneficiary access to care issue does not exist in the counties where the provider or supplier proposes to operate, the application will be rejected and the application fee will be refunded. A provider or supplier whose application has been rejected may submit a new application at any time. If any subsequent application demonstrates an access to care issue, then we may move forward with processing the application.

When we determine that beneficiary access to care is limited in the counties where the provider or supplier has proposed to enroll, we will continue to the next step in processing the application. We will utilize the ownership information in the submitted CMS-855, in conjunction with the information on the PEWD application, to perform the following screening measures:

• License verification.

• Background investigations including evaluation of affiliations as outlined in the March 1, 2016 proposed rule.

• Federal debt review.

• Credit history review.

• Fingerprint-based criminal background checks (FCBC) of persons with a 5 percent or greater direct or indirect ownership interest, partners and managing employees.

• Enhanced site visits.

• Ownership interest verification in LexisNexis and state databases.

• Evaluation of past behavior in other public programs.

If CMS determines that a provider or supplier meets the requirements of the PEWD, it will forward the provider or supplier's CMS 855 application to the Medicare Administrative Contractor (MAC) for further processing. The MAC will process the application and determine whether enrollment is appropriate based on all current enrollment policies and procedures.

In addition to the heightened screening measures previously described, providers or suppliers that enroll via this demonstration will also be subject to a 1-year period of enhanced oversight as authorized by section 1866(j)(3)(A) of the Social Security Act (the Act). As part of this oversight, providers or suppliers that enroll through the demonstration will be limited to furnishing services within a specific geographic area based on beneficiary access to care determinations. Providers and suppliers submitting a PEWD application will specify a requested geographic area. However, this area may be further restricted or expanded based upon CMS's determination regarding the scope of the access to care issue. Claims for services furnished outside of the approved service area will be denied and the provider or supplier may not bill beneficiaries for services outside of the approved service area.

Another aspect of our enhanced oversight during this demonstration will be to closely monitor the billing patterns of providers and suppliers through the Fraud Prevention System (FPS). Any abuse of billing privileges may result in revocation of Medicare enrollment. All applicants who are enrolled through the PEWD will be subject to all Medicare policies and regulations, including the requirement of revalidation of their Medicare enrollment within five years of initial enrollment, in addition to the heightened oversight that is implemented through the demonstration.

If CMS determines there is a beneficiary access to care issue, we will utilize tools that CMS already has in place to facilitate care. Both the regional offices and 1-800-MEDICARE have experience and valuable tools in resolving beneficiary access to care issues, including Home Health Compare and similar provider and supplier locator resources. As current practice dictates, the beneficiary will also be assisted with widening his search, if appropriate, and can be given additional means to assist in finding care, including utilizing the Senior Health Insurance Program (SHIP), an organization that is very experienced in addressing such issues. In the event that the beneficiary is a Medicare Advantage enrollee, then their plan would be contacted and responsible for providing a resolution to their access to care issue.

Throughout the course of the demonstration, CMS will work with all of its state, federal and law enforcement partners to identify fraudulent providers and suppliers and will take administrative action to remove such providers and suppliers from the Medicare program. For example, within 60 days of a provider or supplier's enrollment pursuant to the PEW, we will perform proactive monitoring and oversight of such provider or supplier, including proactive examination of claims data and investigation of billing anomalies. Further, we will prioritize PEWD-related investigations and will make referrals to appropriate law enforcement partners, including Department of Justice (DOJ), Office of Inspector General (OIG), and state law enforcement agencies, for prosecution of fraud.

In addition to the Medicare program, this demonstration will also apply to Medicaid and CHIP. The states will administer the Medicaid and CHIP PEWD and will independently evaluate access to care. If a state determines that a statewide expansion of temporary moratoria would pose unique access to care concerns as compared with more geographically limited moratoria, then the state may elect to lift the moratoria after notifying the Secretary. However, we anticipate that, in the majority of cases, states will be able to use the flexibilities afforded by PEWD to address access to care concerns.

All PEWD-related processes, including but not limited to heightened screening, enrollment, denials, and appeals will be operationalized by the state Medicaid and CHIP agencies in accordance with Federal and State regulations and guidance. The states will make recommendations to CMS regarding when a provider should be enrolled based on access to care, and must wait for CMS concurrence prior to enrolling a provider under the PEWD. CMS will evaluate all recommendations within 30 days of receipt and will advise the state as to whether or not CMS concurs with the recommendation to move forward in the enrollment process. States will not be required to seek approval from CMS to deny a PEWD application. If a provider or supplier receives an enrollment waiver from Medicare, the provider or supplier will be eligible to enroll in Medicaid or CHIP without further review by the states or further concurrence by CMS. However, if a provider or supplier receives a Medicaid or CHIP waiver, the provider or supplier must separately apply for a waiver with Medicare.

CMS will utilize the PEWD as an opportunity to observe the statewide moratoria and heightened application review effectiveness until the moratoria are lifted, or for a total of 3 years, whichever comes first. Should the PEWD prove to be a useful tool, we will explore options for continuing and expanding the most successful aspects outside of the context of a demonstration. The enhanced oversight exercised as part of the demonstration will also allow us to identify trends and vulnerabilities in the moratoria states and make program adjustments to address fraud schemes as they transform over time.

At the conclusion of the demonstration, those enrollments that occurred as part of the PEWD will be converted to standard enrollments without geographical billing restrictions.

The PEWD will begin concurrently with statewide expansion of moratoria of HHAs and ambulance suppliers in 6 states (which will be in place for 6 months with the potential for extensions in 6-month increments) and will commence on July 29, 2016. This demonstration will last until the statewide moratoria are lifted, or for a total of 3 years through (concluding on July 28, 2019), whichever comes first.

In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA) we requested emergency review under 5 CFR 1320.13(a)(2)(i) because public harm is reasonably likely to result if the regular clearance procedures were followed. Interested parties may comment on the collection of information requirements during a 2-week comment period beginning on July 29, 2016. Those comments will be reviewed prior to OMB action. Once approved, any information collection will be active for no more than 6 months.

Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day and 30-day notice in the Federal Register concerning each proposed collection of information requirements. To comply with the PRA, CMS will publish the 60-day Federal Register notice immediately following OMB approval of the emergency information collection requirement (ICR).

To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on the ICRs outlined as follows.

The provider and supplier burden associated with completion of this form is estimated at six hours per form. This will include the following time burden per form:

There will be variation to this estimate based on proximity to a fingerprinting offices as well as the complexity of the data that the provider or suppliers elects to submit. To assist with completion of access to care assessment, CMS has HHA and ambulance saturation data available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-02-22.html.

CMS expects an estimate of 800 new applicants 1 requesting waiver for a total of 4,800 burden hours annually. Additionally, the provider will have the additional burden associated with completion of the CMS-855, which is required for enrollment into Medicare. This burden is covered under OMB control number 0938-0685.

This form will be completed by provider and suppliers seeking a waiver to enroll in a Moratoria area. The cost burden is estimated at $26.00 ($13.00 base pay) an hour for completion of access to care analysis and miscellaneous administrative activities, totaling $65.00 per application, equaling $52,000 annually. The cost burden is estimated at $178.70 ($89.35 base pay) an hour for the owner to obtain fingerprints and waiver form totaling $625.45 per application, equaling $500,360 annually. Estimated annual burden for 800 newly enrolling applicants totals $552,360.To derive average costs, we used date from the Bureau of Labor Statistics' May 2015 National Occupational Employment and Wage Estimates (http://www.bls.gov/oes/current/oes_nat.htm#31-0000 for healthcare support occupations and http://www.bls.gov/oes/current/oes111011.htm for chief executives.) Hourly wage rates include the costs of fringe benefits (calculated at 100 percent of salary) and the adjusted hourly wage.

We welcome comments on all burden estimates contained in the collection of information section of this notice. If you comment on these information collection and recordkeeping requirements, please do either of the following:

1. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, (CMS-10629), Fax: (202) 395-6974; or Email: [email protected].

Under section 402(b) of Pub. L. 90-248 (42 U.S.C. 1395b-1(b)), certain requirements of the Act and implementing regulations will be waived in order to implement this demonstration. Specifically, CMS will waive the following authorities in Florida, Illinois, Michigan, New Jersey, Pennsylvania, and Texas:

• Waiver of § 424.518(c) and (d) and 455.434(a) which describe the fingerprinting rules for enrollment in Medicare, Medicaid and CHIP.2 This waiver involves expanding the existing regulatory authority in two ways: (1) To include ambulance suppliers requesting a PEW waiver within the categories of providers and suppliers to which the FCBC requirements apply; and (2) to include managing employees within the associated individuals subject to an FCBC when the provider or supplier seeks to enroll according to the PEW. Additionally, we intend to modify the authority which currently requires denial or revocation of providers or suppliers who fail to submit fingerprints, to instead specify that a PEWD application will be rejected if the provider or supplier fails to submit the required fingerprints within 30 days.

• Waiver of section 1866(j)(3)(B) of the Act, which requires program instruction or regulatory interpretation in order to implement section 1866(j)(3) of the Act for the provisional period of enhanced oversight for new providers of services and suppliers. We intend to implement the requirements of section 1866(j)(3) of the Act for purposes of this demonstration and in the absence of regulation or other instruction in order to allow for a 1-year period of enhanced oversight of newly enrolling providers and suppliers under this demonstration.

• Waiver of § 424.545, Part 498 Subparts D and E, and § 405.803(b) of the regulations, as well as section 1866(j)(8) of the Act which allow a provider or supplier the right to request a hearing with an administrative law judge and the Department Appeals Board in the case of denial of an enrollment application. Denials of enrollment pursuant to this demonstration will be appealable only to CMS, and any applicant to the PEWD will waive their right to further appeal.

• Waiver of section 1866(j)(7) of the Act and §§ 424.570 and 455.470 of the regulations which specify that the moratoria must be implemented at a provider- or supplier-type level, in order to allow a case-by-case exception process to moratoria.

I. Background A. CMS' Implementation of Temporary Enrollment Moratoria

Under the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively known as the Affordable Care Act), the Congress provided the Secretary with new tools and resources to combat fraud, waste, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Section 6401(a) of the Affordable Care Act added a new section 1866(j)(7) to the Social Security Act (the Act) to provide the Secretary with authority to impose a temporary moratorium on the enrollment of new Medicare, Medicaid or CHIP providers and suppliers, including categories of providers and suppliers, if the Secretary determines a moratorium is necessary to prevent or combat fraud, waste, or abuse under these programs. Section 6401(b) of the Affordable Care Act added specific moratorium language applicable to Medicaid at section 1902(kk)(4) of the Act, requiring States to comply with any moratorium imposed by the Secretary unless the State determines that the imposition of such moratorium would adversely impact Medicaid beneficiaries' access to care. Section 6401(c) of the Affordable Care Act amended section 2107(e)(1) of the Act to provide that all of the Medicaid provisions in sections 1902(a)(77) and 1902(kk) are also applicable to CHIP.

In the February 2, 2011 Federal Register (76 FR 5862), CMS published a final rule with comment period titled, “Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers,” which implemented section 1866(j)(7) of the Act by establishing new regulations at 42 CFR 424.570. Under § 424.570(a)(2)(i) and (iv), CMS, or CMS in consultation with the Department of Health and Human Services' Office of Inspector General (HHS-OIG) or the Department of Justice (DOJ), or both, may impose a temporary moratorium on newly enrolling Medicare providers and suppliers if CMS determines that there is a significant potential for fraud, waste, or abuse with respect to a particular provider or supplier type, or particular geographic locations, or both. At § 424.570(a)(1)(ii), CMS stated that it would announce any temporary moratorium in a Federal Register document that includes the rationale for the imposition of such moratorium. This document fulfills that requirement.

In accordance with section 1866(j)(7)(B) of the Act, there is no judicial review under sections 1869 and 1878 of the Act, or otherwise, of the decision to impose a temporary enrollment moratorium. A provider or supplier may use the existing appeal procedures at 42 CFR part 498 to administratively appeal a denial of billing privileges based on the imposition of a temporary moratorium; however the scope of any such appeal is limited solely to assessing whether the temporary moratorium applies to the provider or supplier appealing the denial. Under § 424.570(c), CMS denies the enrollment application of a provider or supplier if the provider or supplier is subject to a moratorium. If the provider or supplier was required to pay an application fee, the application fee will be refunded if the application was denied as a result of the imposition of a temporary moratorium (see § 424.514(d)(2)(v)(C)).

Based on this authority and our regulations at § 424.570, we initially imposed moratoria to prevent enrollment of new HHAs, subunits, and branch locations 1 (hereafter referred to as HHAs) in Miami-Dade County, Florida and Cook County, Illinois, as well as surrounding counties, and Medicare Part B ground ambulance suppliers in Harris County, Texas and surrounding counties, in a notice issued on July 31, 2013 (78 FR 46339). We exercised this authority again in a notice published on February 4, 2014 (79 FR 6475) when we extended the existing moratoria for an additional 6 months and expanded them to include enrollment of HHAs in Broward County, Florida; Dallas County, Texas; Harris County, Texas; and Wayne County, Michigan and surrounding counties, and enrollment of ground ambulance suppliers in Philadelphia, Pennsylvania and surrounding counties. Then, we further extended these moratoria in documents issued on August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), July 28, 2015 (80 FR 44967), and February 2, 2016 (81 FR 5444).

In imposing these enrollment moratoria, CMS considered both qualitative and quantitative factors suggesting a high risk of fraud, waste, or abuse. CMS relied on law enforcement's longstanding experience with ongoing and emerging fraud trends and activities through civil, criminal, and administrative investigations and prosecutions. CMS' determination of a high risk of fraud, waste, or abuse in these provider and supplier types within these geographic locations was then confirmed by CMS' data analysis, which relied on factors the agency identified as strong indicators of risk. (For a more detailed explanation of this determination process and of these authorities, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475)).

Because fraud schemes are highly migratory and transitory in nature, many of CMS' program integrity authorities and anti-fraud activities are designed to allow the agency to adapt to emerging fraud in different locations. The laws and regulations governing CMS' moratoria authority give us flexibility to use any and all relevant criteria for future moratoria, and CMS may rely on additional or different criteria as the basis for future moratoria.

The February 2, 2011 final rule also implemented section 1902(kk)(4) of the Act, establishing new Medicaid regulations at § 455.470. Under § 455.470(a)(1) through (3), the Secretary may impose a temporary moratorium, in accordance with § 424.570, on the enrollment of new providers or provider types after consulting with any affected State Medicaid agencies. The State Medicaid agency must impose a temporary moratorium on the enrollment of new providers or provider types identified by the Secretary as posing an increased risk to the Medicaid program unless the State determines that the imposition of such moratorium would adversely affect Medicaid beneficiaries' access to medical assistance and so notifies the Secretary. The final rule also implemented section 2107(e)(1)(D) of the Act by providing, at § 457.990 of the regulations, that all of the provisions that apply to Medicaid under sections 1902(a)(77) and 1902(kk) of the Act, as well as the implementing regulations, also apply to CHIP.

Section 1866(j)(7) of the Act authorizes imposition of a temporary enrollment moratorium for Medicare, Medicaid, and/or CHIP, “if the Secretary determines such moratorium is necessary to prevent or combat fraud, waste, or abuse under either such program.” While there may be exceptions, CMS believes that generally, a category of providers or suppliers that poses a risk to the Medicare program also poses a similar risk to Medicaid and CHIP. Many of the new anti-fraud provisions in the Affordable Care Act reflect this concept of “reciprocal risk” in which a provider that poses a risk to one program poses a risk to the other programs. For example, section 6501 of the Affordable Care Act titled, “Termination of Provider Participation under Medicaid if Terminated Under Medicare or Other State Plan,” which amends section 1902(a)(39) of the Act, requires State Medicaid agencies to terminate the participation of an individual or entity if such individual or entity is terminated under Medicare or any other State Medicaid plan. Additional provisions in title VI, Subtitles E and F of the Affordable Care Act also support the determination that categories of providers and suppliers pose the same risk to Medicaid as to Medicare. Section 6401(a) of the Affordable Care Act required us to establish levels of screening for categories of providers and suppliers based on the risk of fraud, waste, and abuse determined by the Secretary. Section 6401(b) of the Affordable Care Act required State Medicaid agencies to screen providers and suppliers based on the same levels established for the Medicare program. This reciprocal concept is also reflected in the Medicare moratoria regulations at § 424.570(a)(2)(ii) and (iii), which permit CMS to impose a Medicare moratorium based solely on a State imposing a Medicaid moratorium. Accordingly, CMS has determined that there is a reasonable basis for concluding that a category of providers or suppliers that poses a risk to Medicare also poses a similar risk to Medicaid and CHIP, and that a moratorium in all of these programs is necessary to effectively combat this risk.

In consultation with the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ), CMS previously identified two provider and supplier types in nine geographic locations that warrant a temporary enrollment moratorium. For a more detailed discussion of this consultation process, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475).

In addition to consulting with law enforcement, CMS also analyzed its own data to identify specific provider and supplier types within geographic locations with significant potential for fraud, waste or abuse, therefore warranting the imposition of enrollment moratoria.

Four of the six states subject to the temporary enrollment moratoria for HHAs and Part B non-emergency ground ambulance suppliers have counties that contain or are adjacent to HEAT Medicare Fraud Strike Force locations, with the exception of Pennsylvania and New Jersey. All six states are also consistently ranked near the top for the identified metrics among counties with at least 200,000 Medicare beneficiaries in 2012.

Beneficiary access to care in Medicare, Medicaid, and CHIP is of critical importance to CMS and its State partners, and CMS carefully evaluated access for the target moratorium locations with every imposition and extension of the moratoria. Prior to imposing these moratoria, CMS reviewed Medicare data for these areas and found no concerns with beneficiary access to HHAs or ground ambulance suppliers. CMS also consulted with the appropriate State Medicaid Agencies and with the appropriate State Departments of Emergency Medical Services to determine if the moratoria would create access to care concerns for Medicaid and CHIP beneficiaries in the targeted locations and surrounding counties. All of CMS' State partners were supportive of CMS' analysis and proposals, and together with CMS, determined that these moratoria would not create access to care issues for Medicaid or CHIP beneficiaries.

Under § 424.570(a)(1)(iii), a temporary moratorium does not apply to changes in practice locations, changes to provider or supplier information such as phone number, address, or changes in ownership (except changes in ownership of HHAs that require initial enrollments under § 424.550). Also, in accordance with § 424.570(a)(1)(iv), the moratorium does not apply to an enrollment application that a CMS contractor has already approved, but has not yet entered into the Provider Enrollment Chain and Ownership System (PECOS) at the time the moratorium is imposed.

In accordance with § 424.570(b), a temporary enrollment moratorium imposed by CMS will remain in effect for 6 months. If CMS deems it necessary, the moratorium may be extended in 6-month increments. CMS will evaluate whether to extend or lift the moratorium before the end of the initial 6-month period and, if applicable, any subsequent moratorium periods. If one or more of the moratoria announced in this document are extended, CMS will publish a document regarding such extensions in the Federal Register.

As provided in § 424.570(d), CMS may lift a moratorium at any time if the President declares an area a disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, if circumstances warranting the imposition of a moratorium have abated, if the Secretary has declared a public health emergency, or if, in the judgment of the Secretary, the moratorium is no longer needed.

Once a moratorium is lifted, the provider or supplier types that were unable to enroll because of the moratorium will be designated to CMS' high screening level under §§ 424.518(c)(3)(iii) and 455.450(e)(2) for 6 months from the date the moratorium was lifted.

CMS previously imposed moratoria on the enrollment of new Part B ground ambulance suppliers in the Texas counties of Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller; the Pennsylvania counties of Bucks, Delaware, Montgomery, and Philadelphia; and the New Jersey counties of Burlington, Camden, and Gloucester. These moratoria became effective upon publication of the notice in the Federal Register on July 31, 2013 (78 FR 46339) and the moratoria document on February 4, 2014 (79 FR 6475), and were subsequently extended by documents published in the Federal Register on August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), and July 28, 2015 (80 FR 44967), and February 2, 2016 (81 FR 5444).

Throughout the duration of the temporary moratoria on newly enrolling Part B ground ambulance providers, CMS has evaluated the risk to the Medicare program of separate categories of ambulance suppliers. This evaluation has shown that the primary risk to the program comes from the non-emergency ambulance supplier category. Additionally, we have observed potential access to care related issues for emergency ambulance services in some areas. As a result, CMS is not extending the temporary moratoria on the enrollment of Part B emergency ground ambulance suppliers in any geographic locations in the states of New Jersey, Pennsylvania, or Texas. However, we will continue to evaluate all ambulance services for indicators of fraud, waste, and abuse and will evaluate the need for future moratoria based on these indicators. The lifting of the moratorium on new Part B emergency ambulance suppliers in all geographic locations also applies to Medicaid and CHIP. New Part B suppliers of emergency ambulance services will be permitted to enroll as of July 29, 2016. Any such suppliers that enroll within 6 months of that date will be included in the “high” risk screening category, as provided in § 424.518(c)(3). New emergency ambulance suppliers that furnish both emergency and non-emergency services will only be able to bill for emergency transportation services.

CMS previously imposed moratoria on the enrollment of new HHAs in the Florida counties of Broward, Miami-Dade, and Monroe; the Illinois counties of Cook, DuPage, Kane, Lake, McHenry, and Will; the Michigan counties of Macomb, Monroe, Oakland, Washtenaw, and Wayne; and the Texas counties of Brazoria, Chambers, Collin, Fort Bend, Galveston, Dallas, Harris, Liberty, Denton, Ellis, Kaufman, Montgomery, Rockwall, Tarrant, and Waller. Further, we previously imposed moratoria on the enrollment of new ground ambulance suppliers in the Texas counties of Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller; the Pennsylvania counties of Bucks, Delaware, Montgomery, and Philadelphia; and the New Jersey counties of Burlington, Camden, and Gloucester. These moratoria became effective upon publication of the notice in the Federal Register on July 31, 2013 (78 FR 46339) and the moratoria document on February 4, 2014 (79 FR 6475), and were subsequently extended by documents published in the Federal Register on August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), July 28, 2015 (80 FR 44967)), and February 2, 2016 (81 FR 5444).

As provided in § 424.570(b), CMS may deem it necessary to extend previously-imposed moratoria in 6-month increments. Under this authority, CMS is extending the temporary moratoria on the Medicare enrollment of HHAs and Part B non-emergency ground ambulance suppliers in the geographic locations discussed herein. Under regulations at § 455.470 and § 457.990, these moratoria also apply to the enrollment of HHAs and non-emergency ground ambulance suppliers in Medicaid and CHIP. Under § 424.570(b), CMS is required to publish a document in the Federal Register announcing any extension of a moratorium, and this extension of moratoria document fulfills that requirement.

CMS consulted with the HHS-OIG regarding the extension of the moratoria on new HHAs and Part B non-emergency ground ambulance suppliers in all of the moratoria counties, and HHS-OIG agrees that a significant potential for fraud, waste, and abuse continues to exist regarding those provider and supplier types in these geographic areas. The circumstances warranting the imposition of the moratoria have not yet abated, and CMS has determined that the moratoria are still needed as we monitor the indicators and continue with administrative actions to combat fraud and abuse, such as payment suspensions and revocations of provider/supplier numbers. (For more information regarding the monitored indicators, see the February 4, 2014 moratoria document (79 FR 6475)).

Based upon CMS' consultation with the relevant State Medicaid agencies, CMS has concluded that extending these moratoria will not create an access to care issue for Medicaid or CHIP beneficiaries in the affected counties at this time. CMS also reviewed Medicare data for these areas and found there are no current problems with access to HHAs or ground ambulance suppliers. Nevertheless, the agency will continue to monitor these locations to make sure that no access to care issues arise in the future.

Based upon our consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.

CMS has determined that the factors initially evaluated to implement the temporary moratoria show that a high risk of fraud, waste, and abuse exists beyond the current moratoria areas, which may suggest that a high risk of fraud, waste, or abuse exists due largely to circumvention of the moratoria by some providers and suppliers. The primary means of circumvention includes enrolling a new practice location outside of a moratorium area and servicing beneficiaries within the moratorium area. Additionally, CMS has continued to see areas of saturation that exceed the national average in the moratoria states. As a result, CMS, in consultation with the OIG, has determined that it is necessary to expand the temporary moratoria on a statewide basis, by implementing temporary moratoria on all newly enrolling HHAs in the remaining counties in Florida, Illinois, Michigan, and Texas, and on all newly enrolling Part B non-emergency ground ambulance suppliers in the remaining counties in Texas, New Jersey, and Pennsylvania, in order to combat fraud, waste, or abuse in those states. CMS has determined that these moratoria will also apply to Medicaid and CHIP in each state, although states continue to have the ability to opt out if they determine that the imposition of such moratorium would adversely impact Medicaid beneficiaries' access to care.

In the document published on February 4, 2014 (79 FR 6475) initially imposing the temporary moratorium on enrollment of HHAs in Broward County, Florida, CMS stated that “it is not necessary to extend the moratorium to the other counties that border Broward because of the state's home health licensing rules that prevent providers enrolling in these counties from serving beneficiaries in Broward.” However, through data analytics, we have determined that these state licensure restrictions are not adequate deterrents to prevent a provider from enrolling in one county and servicing beneficiaries in other counties. In some cases, CMS has observed that providers are servicing beneficiaries located over 300 miles from their practice location.

As a result of this and other data analyses, CMS has determined that it is necessary to expand these moratoria to be statewide. Accordingly, beginning on the effective date of this document, no new HHAs will be enrolled in Medicare, Medicaid, or CHIP with a practice location in Florida, Illinois, Michigan, or Texas unless their enrollment application has already been approved but not yet entered into PECOS for Medicare or the State Provider/Supplier Enrollment System for Medicaid and CHIP as of the effective date of this document. Additionally, no new Part B non-emergency ground ambulance supplier will be enrolled into Medicare, Medicaid, or CHIP with a practice location in Texas, New Jersey, or Pennsylvania unless their enrollment application has already been approved but not yet entered into PECOS for Medicare or the State Provider/Supplier Enrollment System for Medicaid and CHIP as of the effective date of this document.

Beneficiary access to care in Medicare, Medicaid, and CHIP is of critical importance to CMS and its State partners, and CMS carefully evaluated access for the target moratorium locations. CMS recognizes the increased risk of beneficiary access to care issues when implementing statewide moratoria. In order to address this issue, we have performed a detailed access to care analysis for all moratoria states, and identified the counties with lower saturation of home health and Part B ground ambulance providers or suppliers.2 These data include an evaluation of provider and supplier saturation, provider or supplier to beneficiary ratios, and claims data in the Medicare program. Beneficiary access to care is a primary concern for CMS, and we will continue to utilize these data to address the lowest saturation areas. As a continual measure, CMS will update and evaluate these data to monitor attrition of home health and Part B ground ambulance providers or suppliers from Medicare and make certain that beneficiaries in counties with lower provider or supplier saturation are not negatively impacted by the moratoria or related enforcement activities. Any beneficiary that experiences access to care issues may report them to 1-800-MEDICARE or their state's Quality Improvement Organization (QIO) for resolution.

CMS does not currently have the regulatory authority to implement an exception process to respond to beneficiary access to care issues; therefore, concurrently with the statewide moratoria implementation, CMS is announcing a demonstration under the authority provided in Section 402(a)(l)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-l(a)(l)(J)) that waives certain authorities and allows for such exceptions. The demonstration will, among other things, allow for access to care-based exceptions to the moratoria in certain limited circumstances. This will allow enrollment of a provider or supplier after a heightened review of that provider has been conducted.

CMS has determined that this exception process will also apply to Medicaid and CHIP providers in each state. CMS will work collaboratively with states to implement this demonstration in a way that accommodates the access to care needs of beneficiaries in each state.

Details of the demonstration may be found at elsewhere in this issue of the Federal Register.

CMS is executing its authority under sections 1866(j)(7), 1902(kk)(4), and 2107(e)(1)(D) of the Act to extend and implement temporary enrollment moratoria on HHAs for all counties in Florida, Illinois, Michigan, and Texas, as well as Part B non-emergency ground ambulance suppliers for all counties in New Jersey, Pennsylvania, and Texas.

Section 1866(j)(7)(B) of the Act states that there shall be no judicial review under section 1869, section 1878, or otherwise, of a temporary moratorium imposed on the enrollment of new providers of services and suppliers if the Secretary determines that the moratorium is necessary to prevent or combat fraud, waste, or abuse. Accordingly, our regulations at 42 CFR 498.5(l)(4) state that for appeals of denials based on a temporary moratorium, the scope of review will be limited to whether the temporary moratorium applies to the provider or supplier appealing the denial. The agency's basis for imposing a temporary moratorium is not subject to review. Our regulations do not limit the right to seek judicial review of a final agency decision that the temporary moratorium applies to a particular provider or supplier. In the preamble to the February 2, 2011 (76 FR 5918) final rule with comment period establishing this regulation, we explained that “a provider or supplier may administratively appeal an adverse determination based on the imposition of a temporary moratorium up to and including the Department Appeal Board (DAB) level of review.” We are clarifying that providers and suppliers that have received unfavorable decisions in accordance with the limited scope of review described in § 498.5(l)(4) may seek judicial review of those decisions after they exhaust their administrative appeals. However, we reiterate that section 1866(j)(7)(B) of the Act precludes judicial review of the agency's basis for imposing a temporary moratorium.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

CMS has examined the impact of this document as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 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). A regulatory impact analysis (RIA) must be prepared for major regulatory actions with economically significant effects ($100 million or more in any1 year). This document will prevent the enrollment of new home health providers and Part B non-emergency ground ambulance suppliers in Medicare, Medicaid, and CHIP. Though savings may accrue by denying enrollments, the monetary amount cannot be quantified. After the imposition of the initial moratoria on July 31, 2013, 889 HHAs, and 19 ambulance companies in all geographic areas affected by the moratoria had their applications denied. We have found the number of applications that are denied after 60 days declines dramatically, as most providers and suppliers will not submit applications during the moratoria period. Therefore, this document does not reach the economic threshold, and thus is not considered a major action.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. CMS is not preparing an analysis for the RFA because it has determined, and the Secretary certifies, that this document will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if an action may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, CMS defines a small rural hospital as a hospital that is located outside of a metropolitan statistical area (MSA) for Medicare payment purposes and has fewer than 100 beds. CMS is not preparing an analysis for section 1102(b) of the Act because it has determined, and the Secretary certifies, that this document will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any regulatory action whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2015, that threshold is approximately $146 million. This document will have no consequential effect on state, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed regulatory action (and subsequent final action) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Because this document does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

In accordance with the provisions of Executive Order 12866, this document was reviewed by the Office of Management and Budget.

The Department of State published a Notice of Proposed Rulemaking (NPRM), Public Notice 9479 at 81 FR 17121, March 28, 2016, with a request for comments. A summary of the proposed changes and the reasons therefor were included in the NPRM. The comment period closed May 27, 2016. The Department did not receive any substantive comments on the rule. One correspondent raised matters that were not relevant to this rulemaking. The Department is now adopting the proposed rule as a final rule without change.

In accordance with the provisions of the Administrative Procedure Act (APA) governing rules promulgated by federal agencies that affect the public (5 U.S.C. 552 and 553), the Department published this rulemaking as a proposed rule and invited public comment. In accordance with the APA, this rulemaking will be effective 30 days after publication.

The Department of State, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. This determination was based on the fact that the changes proposed in this update have no impact on small businesses. The number of small businesses considered for suspension or debarment will not grow or shrink as a result of the proposed changes. The Department analyzed the suspension/debarment actions that occurred in FY14 and no small businesses were impacted.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Act of 1995.

This rule is not a major rule as defined by the Small Business Regulatory Enforcement Act of 1996 (5 U.S.C. 801 et seq.). This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and import markets. This determination was based on the fact that the proposed changes are intended to simplify the procedural aspects of the suspension and debarment process. The rule does not place new requirements on contract performance. The rule does not have a significant cost or administrative impact on offerors or contractors.

Executive Orders (E.O.) 12866 and 13563 direct agencies to assess 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 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Department of State does not consider this rule to be an “economically significant regulatory action” under Executive Order 12866. The Department has reviewed the regulation to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Orders and finds that the benefits of updating this rule outweigh any costs, which the Department assesses to be minimal.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.

The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

The rule imposes no new or revised information collections under the Paperwork Reduction Act of 1980 (44 U.S.C. Chapter 35).

For the reasons stated in the preamble, the Department of State amends 48 CFR chapter 6 as follows:

Background

The Security and Accountability for Every Port Act of 2006 (SAFE Port Act, Pub. L. 109-347) requires all Federal agencies with a role in import admissibility decisions to collect information electronically through the ITDS. The Department of the Treasury has the U.S. Government lead on ITDS development and Federal agency integration. CBP developed Automated Commercial Environment (ACE) as an internet-based system for the collection information for ITDS. The Office of Management and Budget (OMB), through its e-government initiative, oversees Federal agency participation in ITDS, with a focus on reducing duplicate reporting across agencies and migrating paper-based reporting systems to electronic information collection.

The term ITDS refers to the integrated, government-wide project for the electronic collection, use, and dissemination of the international trade and transportation data Federal agencies need to perform their missions, while the term ACE refers to the “single window” system through which the trade community will submit data related to imports and exports. Detailed information on ITDS is available at: http://www.itds.gov.

Numerous Federal agencies are involved in the regulation of international trade and many of these agencies participate in the import, export and transportation-related decision-making process. Agencies also use trade data to monitor and report on trade activity. NMFS is a partner government agency in the ITDS project because of its role in monitoring the trade of certain fishery products. Electronic collection of seafood trade data through a single portal will result in an overall reduction of the public reporting burden and the agency's data collection costs, will improve the timeliness and accuracy of admissibility decisions, and increase the effectiveness of applicable trade restrictive measures.

On December 29, 2015, NMFS published a notice of proposed rulemaking for this action (80 FR 81251) to codify NMFS procedures for collecting information electronically through the ITDS. NMFS prepared a regulatory impact review of this action, which is available from NMFS (see FOR FURTHER INFORMATION CONTACT). This analysis describes the economic impact this action will have on the United States. Responses to public comments received on the proposed rule are set forth below.

A number of changes from the proposed rule were made to clarify the regulatory text and to take account of other final rules affecting 50 CFR part 300 that became effective after the proposed rule for ITDS integration was published.

Although the ITDS single window concept is built on the ACE platform as the reporting mechanism for the trade sector and the source for accessing trade data by the partner agencies, there is a distinction between reporting procedures for imports and exports. The system used to electronically transmit export filings is called the Automated Export System (AES). The primary document for instructing the trade sector on the data requirements for export filing is the Automated Export System Trade Interface Requirements (AESTIR). The primary instructional document for Partner Government Agency (PGA) export requirements is the “Appendix Q” to AESTIR. This document is comparable to the Customs and Trade Automated Interface Requirements (CATAIR) “Appendix PGA” for import transactions. While each PGA has issued a separate Implementation Guide for import requirements as a supplement to CATAIR, all guidance to the trade sector for PGA export requirements is detailed within the AESTIR Appendix Q documents.

The CBP Web page that contains the primary information on export requirements is: https://www.cbp.gov/trade/aes. Details on how to submit export data via AES are available at: https://www.cbp.gov/trade/aes/aestir/introduction-and-guidelines. PGA record formats are listed at: https://www.cbp.gov/document/guidance/aestir-draft-appendix-q-pga-record-formats. The Appendix Q Record Lay Out Key details how each record required should be structured: https://www.cbp.gov/document/guidance/appendix-q-record-layout-key. NMFS has included references to the CBP import and export documentation in § 300.323 of the regulatory text.

NMFS amended the regulatory text for the HMS ITP at 50 CFR 300.181 through 300.189 to reflect the implementation of the electronic bluefin tuna catch document program (81 FR 18796, April 1, 2016).

NMFS amended 50 CFR 300.184 to address the exemption for bigeye tuna described in the Response to Comments section below under the heading “Bi-weekly Reporting.”

NMFS amended 50 CFR part 300.322(a) to clarify that only resident agents in the United States are eligible to be issued the International Fisheries Trade Permit (IFTP). Entities that are not resident in the United States may obtain the IFTP only via a resident agent application.

NMFS amended 50 CFR 300.322(a) and 300.323 to clarify the various transactions which pertain to seafood previously imported for purposes other than immediate consumption and for which the permitting, reporting and recordkeeping requirements apply.

NMFS revised 50 CFR 300.323 to clarify that all imports and exports of covered commodities, including shipments otherwise eligible for the de minimis value exemption, must be filed in ACE or AES, as applicable, in order to collect the NMFS-required information. NMFS also revised 50 CFR 300.324(b) to clarify that de minimis value imports (valued at $800 or less; see 19 U.S.C. 1321(a)(2)(C)) and exports (valued at $2500 or less; see 15 CFR 30.37(a) and 15 CFR 30.2(a)(iv)(F)) are subject to the prohibition on importing/exporting fish or fish products regulated under 50 CFR 300 subpart Q without a valid IFTP or without submitting complete and accurate information through ACE or AES, as applicable.

Low value shipments are not exempt from statutory and regulatory requirements to collect information to support admissibility determinations and to report to the respective regional fishery management organizations on U.S. trade in fish products within the scope of each program. Under the SAFE Port Act, NMFS is required to collect information electronically and through the single window. Therefore, NMFS requires the use of ACE or AES, as applicable, to submit required information. However, CBP may provide other reporting mechanisms for different entry types and/or de minimis value shipments. If these alternative CBP mechanisms can collect all of the NMFS-required information and transmit that information to NMFS, importers and exporters may use these mechanisms to fulfill NMFS reporting requirements.

In publishing the proposed rule for ITDS integration of current trade monitoring programs, NMFS incorrectly numbered the sections of the proposed new subpart R to 50 CFR part 300. A final rule amending regulations implementing the High Seas Fishing Compliance Act (HSFCA) was published on October 16, 2015 (80 FR 62488). That final rule added a new subpart Q to 50 CFR part 300, with sections numbered §§ 300.330 through 300.341. In subsequently proposing a new Subpart R for the ITDS integration regulations, NMFS numbered sections from 300.320 through 300.324.

In order to maintain the correct sequence of section numbers, NMFS is now redesignating existing subpart Q as new subpart R. This final rule then inserts a new subpart Q for the ITDS regulations with sections numbered in the correct order. Given the placement of HSFCA regulations in the new subpart R, conforming amendments are needed for cross-references to HSFCA requirements which exist in 50 CFR 600.705 and 50 CFR 660.2.

NMFS received 12 public comments on the proposed rule. Comments were received from the National Customs Brokers and Forwarders Association of America (NCBFAA), Traffic/World Wildlife Fund/Oceana, Bumble Bee Seafoods, Tri Marine Management Company LLC, and two individuals potentially affected by new requirements in this rule.

Comment 1: NCBFAA noted that although the data submission requirements under the proposed rule are not new, this data has not previously been required to be submitted at the time of entry/release. They noted that submitting data at the time of entry/release not only increases processing costs for the importer, but also raises the potential for disruptions as the data moves through the ACE pipeline to CBP and NMFS. NCBFAA questioned the need for NMFS to collect all data elements at the time of entry/release and asked whether NMFS' requirements could be met if the information was provided via the entry summary which may be filed electronically within 10 days after entry/release. NCBFAA noted that moving these data submission requirements to entry summary would provide much needed flexibility for importers and customs brokers to handle complex entries without slowing down trade and would suit NMFS needs because NMFS would not be able to review data until after entry/release.

Response: NMFS believes that submission of data at the time of entry/release is necessary to ensure only admissible products are permitted entry into the U.S. market. Allowing data entry for these three programs after product has been admitted into the United States would make efforts to interdict problematic entries extremely difficult. NMFS also emphasizes that it is only requiring the minimum amount of data necessary to determine whether a product is admissible at the time of entry be provided as a data set at the time of entry. This approach should expedite the release of product associated with the three NMFS trade monitoring programs.

Comment 2: NCBFAA noted it does not object to consolidating the existing trade permits as proposed in the rule; however they noted that in some instances, particularly along land borders, customs brokers serve as the importer of record. NCBFAA stated its view that the IFTP should not be required for an importer of record who is not a beneficial party in interest, such as a customs broker. NCBFAA therefore suggested the rule be modified to clarify that the permit obligation, and associated recordkeeping and reporting requirements, belong to the “beneficial party in interest” which should be defined as a party with a financial interest in the imported goods such as the owner, purchaser, or distributor of the merchandise.

Response: NMFS believes it is important for enforcement purposes that the importer of record, regardless of whether said importer has a direct financial interest in the imported goods, be the responsible party accountable in the event of a shipment entry problem. Thus, the IFTP obligation and associated recordkeeping and reporting requirements in this rule will reside with the importer of record. Related to this, NMFS clarifies that entities not resident in the United States are ineligible to apply for the IFTP. Nonresident importers must have a U.S. resident agent apply for the IFTP and have the customs broker provide the resident agent's permit number in the entry data. NMFS has clarified the regulatory text at 50 CFR 300.322(a) accordingly.

Comment 3: NCBFAA noted that the rule does not address NMFS requirements with regard to Informal Entries (valued at $2,500) or Section 321 entries (shipments of “de minimis value”, increased from $200 to $800 by Section 601 of the Trade Facilitation and Trade Enforcement Act, Pub. L. 114-376). NCBFAA noted that with the de minimis threshold raised to $800, the practice of breaking commercial shipments into lower-value increments will likewise increase, in effect allowing these imports to bypass the more formalized requirements of entry processing. NCBFAA stated its view that NMFS needs to address how it will meet this contingency.

Response: NMFS' requirement with regard to Informal Entries will be the same as those for all other entries, namely all entries associated with the HTS codes corresponding to the three seafood import monitoring programs will need to supply message sets and documentation into ACE via the Document Imaging System (DIS). Similarly, de minimis shipments corresponding to the relevant HTS codes which are valued at less than $800 will also need to supply message sets and documentation into ACE via the DIS to ensure that no inadmissible products are granted entry into the U.S. market. NMFS therefore revised 50 CFR 300.323 to clarify that all imports and exports of covered commodities, including shipments otherwise eligible for the de minimis value exemption, must be filed in ACE or AES, as applicable, in order to collect the NMFS-required information. NMFS also revised 50 CFR 300.324(b) to clarify that de minimis value imports are also subject to the prohibition on importing fish or fish products regulated under 50 CFR part 300 subpart Q without a valid IFTP or without submitting complete and accurate information. Likewise, low value exports are subject to AES filing to meet the NMFS requirements for permitting and reporting (see 15 CFR 30.2(a)(iv)(F)). However, NMFS has made provisions for cases where CBP reporting alternatives can capture and transmit the NMFS-required information without a formal entry or export filing in ACE or AES, as applicable.

Comment 4: NCBFAA noted that the proposed regulatory text at §§ 300.322(a) and 300.323 refers to persons who import “for consumption or non-consumption.” NCBFAA noted that the term “import for consumption” has a very specific legal meaning under customs law, whereas, the term “import for non-consumption” has no particular meaning under customs law. NCBFAA therefore suggested that commonly used customs terms be used to clarify the application of the proposed rule.

Response: NMFS agrees that the term “import for non-consumption” should be clarified and has therefore amended the regulatory text at §§ 300.322(a) and 300.323 to specify the various transactions which pertain to seafood previously imported for purposes other than immediate consumption, e.g. withdrawal from a foreign trade zone or bonded warehouse for entry into U.S. commerce.

Comment 5: Traffic et al. conveyed its understanding that in the initial phases of ITDS implementation, document image scans will be used to transmit the catch documentation forms. Traffic et al. stated its view that the key goal must be to eventually move away from paper-based documentation, including imaged documents, to truly electronic data. Traffic et al. stated its hope that NMFS, in conjunction with CBP, will put in place systems to receive all information in a truly electronic format, at least before the implementation date of the proposed seafood import monitoring program or at some set time thereafter, noting that the value of this system, in terms of real-time verification and compliance risk assessment, cannot be achieved without that change.

Response: Many of the paper-based catch documentation forms referenced in this comment are created by regional fishery management organizations (RFMOs) or arrangements that are comprised of different member countries including the United States. ITDS therefore cannot be made fully electronic until action in this direction is taken by the relevant RFMOs or arrangements. For example, the TTVP requires certification from tuna captains from all over the world, including many that fish in remote artisanal fisheries where Internet connectivity is not commonplace, even today. Having said that, however, NMFS agrees it is important to move to a fully electronic system as soon as the relevant international catch documentation schemes go electronic. NMFS notes that the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) and the International Convention for the Conservation of Atlantic Tunas (ICCAT) have moved in the direction of electronic catch documentation systems which have simplified import/export processes for the trade and NMFS expects this trend in other organizations in the future.

Comment 6: Traffic et al. noted its view that capacity building to assist some countries with implementing the new rules will be necessary. Traffic et al. noted its hope that NMFS, USAID, the State Department and other agencies will be able to work with countries to help develop electronic reporting systems that can produce the information needed at the point of catch and feed into traceability systems that will follow the product throughout the supply chain.

Response: NMFS agrees and is taking steps to do this. For example, NMFS is working with the Department of State and USAID on a Regional Development Mission Asia project in Southeast Asia to enhance seafood traceability infrastructure among the developing countries of this region.

Comment 7: Traffic et al. noted its view that similar requirements for electronic submission of catch documentation eventually be applied to all species to effectively combat fraud and the flow of IUU products.

Response: Although not germane to this rule, NMFS agrees (as noted in the Seafood Import Monitoring Program proposed rule published in the Federal Register on February 5, 2016) that seafood traceability requirements should eventually be applied to all species in an effort to combat seafood fraud and IUU fishing. As noted in the March 2015 Presidential Task Force report, the National Oceans Committee will issue a report by December 2016 that includes an evaluation of the program as implemented to date as well as recommendations of how and under what timeframe it would be expanded.

Comment 8: Bumble Bee noted that the proposed rule includes provisions for the submission of a “reduced data set” for domestic canners who import frozen tuna loins with the stated objective of preventing duplicative report for companies that submit monthly reports associated with the TTVP. Bumble Bee further noted that the recently released Seafood Import Monitoring Program proposed rule also references collection of data via a “NMFS message set” but the content, specific format, and timing to begin reporting of both the “reduced data set” and the “NMFS message set” appear to not yet be defined. Bumble Bee urged that the rollout of the “reduced data set” reporting proposed in the ITDS implementation rule not be implemented prior to the rollout of the “NMFS Message Set” reporting requirement in the Seafood Import Monitoring Program proposed rule and that NMFS ensures that content and data serve both purposes. Bumble Bee stated its view that implementing a “reduced data set” reporting requirement under the ITDS implementation rule to meet the needs of the TTVP and then implementing another data requirement shortly thereafter to meet traceability reporting requirements seems wasteful and will create additional burden on the trade.

Response: As noted in the NMFS ITDS implementation guidelines (see http://www.cbp.gov/sites/default/files/documents/ACE%20NMFS%20PGA%20MS%20Guidelines%20-%20July%2022%202015.pdf), for cannery processed products that are imported into the U.S. Customs District from American Samoa and for imports of frozen cooked tuna loins, not in airtight containers, not in oil and with contents over 6.8 kilograms from any country of origin, certain data usually or otherwise required at the time of filing need not be submitted if provided to NMFS under the regulations found at 50 CFR 216.93(d)(2). Under these specific conditions, NMFS will only require a “reduced data set” consisting of an acknowledgement that an electronic image is associated with the shipment and also that the document images of the NOAA Form 370(s) associated with the shipment have been uploaded into the CBP DIS. Given the different timelines for implementation of these two regulations, it will not be possible to implement requirements simultaneously; however, NMFS will make every effort to avoid creating additional burdens on the trade in the course of implementing these programs.

Comment 9: Bumble Bee stated its understanding that under the proposed rule, companies who are part of the TTVP would now need to obtain an IFTP. Bumble Bee does not object to this requirement, but noted that in the reporting and recordkeeping requirements in section 300.183 of the proposed rule that biweekly reporting is required for holders of the IFTP. Bumble Bee requested confirmation that the existing bi-weekly reporting requirements associated with the IFTP will remain limited to species currently part of the HMS ITP with the existing reporting exemption for bigeye tuna destined for canneries.

Response: NMFS confirms that the import documentation requirements, as well as the bi-weekly reporting requirements, associated with the HMS ITP will remain limited to species currently part of that program. The reporting exemption for bigeye tuna destined for canneries harvested by either purse seiners or pole and line (bait) vessels will continue. The regulations pertaining to this exemption were inadvertently removed during a previous rulemaking (77 FR 52259, August 29, 2012) and have been restored in the regulatory text at 50 CFR 300.184. NMFS would also like to clarify that under this rule, documentation such as the HMS ITP biweekly dealer reports, which are not required at the time of entry/export, will continue to be provided to the HMS ITP office and are not submitted to CBP via the ACE portal.

Comment 10: Tri Marine voiced its concern about the administrative and financial burden the proposed rule may pose and that this aspect was not adequately addressed in the Regulatory Flexibility Act section of the proposed rule. Tri Marine noted that direct and indirect costs associated with new requirements under the rule are difficult to determine at this time and that the primary beneficiary of the efficiencies gained would be U.S. government agencies and companies that also trade in non-TTVP species/products. Tri Marine encouraged NMFS to reconsider options that best mitigate potential economic impacts to industries that trade exclusively in TTVP species while still achieving desired outcomes. Tri Marine agrees TTVP companies should be required to obtain the IFTP, but without a fee and with minimal filing burden. Tri Marine suggested updated templates for the NOAA 370 form and Captain's Statements should be designed that readily integrate into ACE. Tri Marine noted information required should always include the market name and scientific names of all species used in the product, not only simplified names such as light meat tuna that can mask the actual inputs used. Tri Marine encouraged NMFS to engage with the FDA to change the standard of identity for canned tuna to require the species name of all inputs be provided on canned tuna labels.

Response: In determining its preferred alternative for this rulemaking, NMFS made best efforts to balance potential economic impacts on the trade with the rulemaking's desired outcomes. NMFS believes extending the IFTP requirement to TTVP-related companies to be both the most equitable and effective alternative among those presented in the proposed rule. The cost of the IFTP is only $30 and is calculated solely based upon the administrative cost to NMFS of issuing the permit. Requiring the permit for all three programs also allows NMFS to easily notify permit holders of any changes to the relevant regulations or import monitoring program procedures. NMFS appreciates the suggestion to update templates for the TTVP 370 form and Captain's Statements for improved integration with ACE and will work with CBP to consider this suggestion further. Although the comment regarding market and scientific names is outside the scope of this rulemaking, this issue has been discussed by NMFS, the FDA, and other agencies in response to Recommendation 10 of the Presidential Task Force to Combat IUU Fishing and Seafood Fraud. (See www.iuufishing.noaa.gov).

Comment 11: Tri Marine recognized the proposed rule allows for a reduced data set for imports of 1) frozen cooked tuna loins used in cannery operations and 2) tuna products in airtight containers manufactured in American Samoa. Although Tri Marine agreed with the intent to prevent duplicative reporting and apply this to imports from American Samoa, it opposed reduced data collection from frozen loin importers. Tri Marine noted that tuna cans from American Samoa are typically produced from fish delivered directly to canneries from the fishing vessel allowing direct traceability from the vessel to processing line to finished product. Tuna loins imported into the United States, however, are typically caught in distant waters, transshipped onto carrier vessels, offloaded into foreign ports, trucked to large cold stores, transferred to foreign processing facilities and then shipped by container vessel to the United States where they are stored and undergo final secondary processing, all of which makes traceability more challenging. Tri Marine therefore recommends more rigorous data sets be required for imported tuna loins.

Response: These comments are germane to the chain of custody requirements proposed under the Seafood Import Monitoring Program (81 FR 6210) rather than under this ITDS implementation rule. However, NMFS notes that the reduced data set applies to all U.S. tuna canning facilities in order to reduce duplication of data elements required under 50 CFR 219.93(d)(2). NMFS will take these comments into consideration when formulating its final rule for the Seafood Import Monitoring Program.

Comment 12: Tri Marine stated its view that there is significant overlap between the ITDS implementation proposed rule and the proposed rule for the Seafood Import Monitoring Program. Tri Marine's view is that since it is highly likely that comments on the Seafood Import Monitoring Program will be useful in guiding the development of a final rule for ITDS implementation, it would be prudent to integrate the final rule for these two initiatives, taking into account comments on both proposed rules.

Response: Although NMFS recognizes there is overlap between the two rules, it will not be possible to integrate the two rules primarily because they have different timelines for implementation with NMFS implementation of ITDS required by July 23, 2016, in order to meet the requirements specified for all Federal agencies in Executive Order 13659 (Streamlining the Export/Import Process) whereas implementation of the Seafood Import Monitoring Program is not expected to occur until the fall of 2016 at the earliest.

This rule is published under the authority of AMLRCA of 1984, 16 U.S.C. 2431 et seq.; ATCA of 1975, 16 U.S.C. 971 et seq.; TCA of 1950, 16 U.S.C. 951-961; MSA, 16 U.S.C. 1801 et seq.; MMPA of 1972, 16 U.S.C. 1361-1407; DPCIA, 16 U.S.C. 1385; HSDFMPA, 16 U.S.C. 1826d-k; and HSDFEA, 16 U.S.C. 1826a-c. Other relevant authorities include the Pelly Amendment to the Fishermen's Protective Act, 22 U.S.C. 1978, and the Lacey Act, 16 U.S.C. 3371.

The NMFS Assistant Administrator has determined that this final rule is consistent with the provisions of these and other applicable laws.

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

As explained above, this final rule revises text at 50 CFR 300.184 that provides an exemption from documentation requirements for bigeye tuna destined for canneries. Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this specific provision of the final rule, because notice and comment would be unnecessary and contrary to the public interest. This text was inadvertently removed in an August 29, 2012 final rule (77 FR 52259), and NMFS only became aware of that fact as it was reviewing and responding to public comments on this current rulemaking. Providing for public comment at this time is unnecessary and contrary to the public interest, as NMFS and industry have been operating as if the exemption remained in place. Further, NMFS never intended to change the exemption and thus never analyzed its removal. Because this aspect of the rule relieves a restriction by reinserting an exemption to documentation requirements, it is not subject to the 30-day delayed effectiveness provision of the APA pursuant to 5 U.S.C. 553(d)(1).

The Chief Counsel for Regulations certified that this rule is not expected to have a significant economic impact on a substantial number of U.S. small entities (80 FR 81255, December 29, 2015).

Although a new IFTP will be established for the import, export or re-export of regulated products under the AMLR, HMS ITP and TTVP programs, this new permit generally represents a consolidation of information contained in existing permits and should actually result in fewer reporting or recordkeeping requirements. Data sets to be entered electronically to determine product admissibility are already required to be submitted in paper form under the respective trade programs. Thus, NMFS anticipates that U.S. entities will not be significantly affected by this action because it generally does not pose new or additional burdens with regard to the collection and submission of information necessary to determine product admissibility.

With regard to the possible economic effects of this action, per the response to Question 13 of the supporting statement prepared for the Paperwork Reduction Act analysis (available from www.reginfo.gov/public/do/PRAMain), NMFS estimates there will be 751 applicants for the new IFTP with an estimated net increase in annual costs of $16,255 for obtaining those permits, based on the combined number of permit holders and respondents under NMFS' existing trade monitoring programs. Although NMFS does not have access to data about the business sizes of importers and receivers that would be impacted by this rule, it is likely that the majority may be classified as small entities. However, when overall total new burdens for the three requirements under this rule (IFTP, data set submission, and admissibility document(s) submission) are compared to current burdens, the new consolidated burdens are estimated to result in an overall net burden decrease of 4,225 hours and $63,650. A no-action alternative, where NMFS would not promulgate the rule, was not considered as all applicable U.S. government agencies are required to implement ITDS under the authority of section 405 of the SAFE Port Act and Executive Order 13659 on Streamlining the Export/Import Process, dated February 19, 2014.

This action will not affect the volume of seafood trade or alter trade flows in the U.S. market. Although the rule will require traders under the TTVP to obtain an IFTP, which they are not currently required to do, NMFS expects that the consolidated IFTP will have no impact on, or will actually reduce, the overall administrative burden on the public; those parties currently required to obtain two separate permits under the AMLR and HMS ITP programs will be required to obtain only one consolidated permit under this rule.

The consolidated permitting and electronic reporting program established under this rulemaking will not have significant adverse or long-term economic impacts on small U.S. entities. This rule has also been determined not to duplicate, overlap, or conflict with any other Federal rules. Thus, the requirements and prohibitions in the rule will not have a significant economic impact on a substantial number of small entities. Consequently, a regulatory flexibility analysis is not required and none has been prepared.

This rule contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under control number 0648-0732. When new reporting burdens for the three electronic reporting requirements under this rule (IFTP, data set submission, and admissibility document submission) are compared to current reporting burdens approved for the separate paper-based programs, it is estimated to result in an overall net burden decrease of 4,225 hours and $63,650.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

For the reasons set out in the preamble, 50 CFR parts 216, 300, 600, and 660 are amended as follows:

The snapper-grouper fishery of the South Atlantic includes lesser amberjack, almaco jack, and banded rudderfish, and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The combined commercial ACL for the other jacks complex is 189,422 lb (85,920 kg), round weight. Under 50 CFR 622.193(l)(1)(i), NMFS is required to close the commercial sector for the other jacks complex when the commercial ACL has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial sector for this complex is projected to reach its ACL by August 9, 2016. Therefore, this temporary rule implements an AM to close the commercial sector for the other jacks complex in the South Atlantic, effective 12:01 a.m., local time August 9, 2016.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having lesser amberjack, almaco jack, or banded rudderfish on board must have landed and bartered, traded, or sold such species prior to 12:01 a.m., local time, August 9, 2016. During the closure, the bag limit specified in 50 CFR 622.187(b)(8) and the possession limits specified in 50 CFR 622.187(c) apply to all harvest or possession of lesser amberjack, almaco jack, or banded rudderfish in or from the South Atlantic EEZ. These bag and possession limits apply in the South Atlantic on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper has been issued, regardless of whether such species were harvested in state or Federal waters. During the closure, the sale or purchase of lesser amberjack, almaco jack, or banded rudderfish taken from the EEZ is prohibited.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the fish in the other jacks complex, a component of the South Atlantic snapper-grouper fishery, and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(l)(1)(i) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and public comment.

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the commercial sector for the other jacks complex constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the AM itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect the other jacks complex since the capacity of the fishing fleet allows for rapid harvest of the commercial ACL. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established commercial ACL.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).