Federal Register Vol. 83, No.122,

Background

Under section 412(a) of the Plant Protection Act (7 U.S.C. 7701 et seq., referred to below as the PPA), the Secretary of Agriculture may prohibit or restrict the movement in interstate commerce of any plant or plant product, if the Secretary determines that the prohibition or restriction is necessary to prevent the dissemination of a plant pest within the United States.

Phytophthora ramorum, commonly known as sudden oak death, ramorum leaf blight, and ramorum dieback, is a harmful pathogen that can cause mortality in several oak tree species and also causes twig and foliar diseases in numerous native and non-native ornamental plants, shrubs, and trees within the United States.

P. ramorum was first discovered in the natural environment in 14 counties in California and portions of 1 county in Oregon. When the disease was subsequently discovered in certain nurseries on the west coast that shipped nursery stock interstate, the Animal and Plant Health Inspection Service (APHIS) issued an interim rule published in the Federal Register on February 14, 2002 (67 FR 6827-6837, Docket No. 01-054-1). The interim rule established a new subpart, “Subpart—Phytophthora ramorum” (7 CFR 301.92 through 301.92-12, referred to below as the regulations), which contains APHIS' regulations to address the spread of P. ramorum.

Section 301.92-3 of the regulations designates certain States and portions of States as quarantined areas for P. ramorum. The regulations also designate other States or portions of States as regulated areas for P. ramorum. Quarantined areas are areas in which P. ramorum has been confirmed by an inspector to exist in the natural environment, in which there is reason to believe P. ramorum exists in the natural environment, or which APHIS considers to be inseparable for quarantine enforcement purposes from localities in which P. ramorum has been found in the natural environment.

Regulated areas are defined in the regulations as areas in which P. ramorum has been found on nursery stock in commercial nurseries, but in which P. ramorum has not been found in the natural environment. The quarantined areas for P. ramorum are designated in paragraph (a) of § 301.92-3. Regulated areas for P. ramorum are designated in paragraph (b) of § 301.92-3. Quarantined areas include 14 counties in California and a portion of 1 county in Oregon. Regulated areas include the remainder of California and Oregon, as well as the State of Washington.

Section 301.92-2 of the regulations designates nursery stock of proven host taxa for P. ramorum as regulated articles for P. ramorum. It also designates nursery stock of taxa associated with P. ramorum, but not proven to be hosts, as associated articles for P. ramorum. Nursery stock of taxa that are neither designated as proven hosts nor as associated with P. ramorum are considered to be non-hosts.

Section 301.92-4 of the regulations contains conditions for the interstate movement of regulated and non-host nursery stock from quarantined areas for P. ramorum. This section also contains conditions for the interstate movement of regulated and non-host nursery stock from regulated areas for P. ramorum. The conditions for movement of both regulated and non-host nursery stock from a quarantined area for P. ramorum are found in paragraphs (a) and (c) of § 301.92-4, while the conditions for interstate movement of both regulated and non-host nursery stock from a regulated area for P. ramorum are found in paragraph (d) of that section.

Paragraph (d) requires certificates to be issued in order for regulated nursery stock to be shipped interstate from a regulated area for P. ramorum, and also requires certificates to be issued for the interstate movement of non-host nursery stock, if the nursery from which the nursery stock originates contains regulated or associated articles for P. ramorum. If the nursery contained only non-host nursery stock, then certificates are not required, provided that the nursery is inspected and found free of evidence of P. ramorum. (We discuss the inspection protocols, which are found in § 301.92-11 of the regulations, in the following paragraphs.)

Section 301.92-5 of the regulations requires that, in order for nurseries in quarantined or regulated areas for P. ramorum to ship regulated or non-host nursery stock interstate under a certificate, the nurseries have to be inspected annually in accordance with inspection and sampling protocols. The inspection and sampling protocols are found in § 301.92-11 of the regulations. The inspection and sampling protocols for nurseries in quarantined areas for P. ramorum that ship regulated or non-host nursery stock interstate are found in paragraphs (a) and (b) of § 301.92-11, respectively, while the inspection and sampling protocols for nurseries in regulated areas for P. ramorum that ship regulated or non-host nursery stock interstate are found in paragraphs (c) and (d) of § 301.92-11, respectively.

Paragraph (c) of § 301.92-11 contains the following inspection and sampling protocol for nurseries in regulated areas for P. ramorum that ship regulated nursery stock interstate: Visual inspection of the nurseries for symptoms of P. ramorum; sampling of plants showing symptoms of infection with P. ramorum; and testing of those samples using an approved test (approved tests and testing protocols for P. ramorum are found in § 301.92-12 of the regulations). While testing is ongoing, the symptomatic plants, the lot containing the symptomatic plants, and plants located within 2 meters of that lot cannot be moved interstate. Nurseries in quarantined areas for P. ramorum are subject to a similar protocol with more stringent inspection requirements. Finally, nurseries in quarantined and regulated areas for P. ramorum that contain and ship only non-host nursery stock are subject to a similar inspection protocol, but are only subject to sampling and testing if an inspector found plants showing symptoms of P. ramorum.

Over a 9-year period, from 2004, when we implemented these protocols, to 2013, APHIS and the State plant protection authorities of California, Oregon, and Washington inspected approximately 3,050 nurseries annually. During that time period, P. ramorum was never detected at a nursery located in a regulated area for P. ramorum and that contains and ships interstate only non-host nursery stock. Additionally, P. ramorum was discovered in the natural environment of only one area that had been regulated for P. ramorum, a portion of Curry County, OR.

Additionally, of the nurseries in regulated areas for P. ramorum that contain and ship interstate regulated nursery stock, P. ramorum was detected at a very small percentage—usually no more than 3 percent annually. The vast majority of the nurseries were found free of P. ramorum each time they were inspected.

If P. ramorum was detected at a nursery during one of these inspections, however, it often was not limited to infected plants. Rather, multiple sources of the inoculum often were detected at the nursery; these include growing media, pots used for nursery stock, standing water, drainage water, and water used for irrigation. This is also true of nurseries that are located in quarantined areas for P. ramorum and in which the disease was detected.

Finally, between 2004 and 2013, APHIS detected P. ramorum in 120 nurseries in areas that are neither quarantined nor regulated for P. ramorum, and in which APHIS has no reason to believe P. ramorum exists in the natural environment. Most of these nurseries were retailers that sell directly to consumers and do not engage in interstate commerce. However, some did ship regulated, restricted, and associated articles interstate. Several of those nurseries tested positive for P. ramorum in their soil, standing water, water for irrigation, or growing media.

This data led us to reevaluate our regulatory strategy for addressing the artificial spread of P. ramorum within the United States. As a result of this reevaluation, we no longer saw a need for regulating geographical areas for P. ramorum unless we determined that the area met the criteria for designation as a quarantined area for P. ramorum. However, we did see a need to regulate nurseries outside of quarantined areas for P. ramorum if the nurseries shipped regulated, restricted, or associated articles interstate and sources of P. ramorum were discovered at the nursery.

Accordingly, in a Federal Order issued on January 10, 2014, and a Federal Order issued on April 3, 2015, we restructured the domestic quarantine program for Phytophthora ramorum. 1 Specifically:

• We deregulated all regulated areas for P. ramorum, and removed all regulatory restrictions specific to those areas.

• Instead of regulated areas for P. ramorum, we implemented regulated establishments for P. ramorum. A regulated establishment is a nursery that is not located in a quarantined area for P. ramorum, that ships regulated, restricted, or associated articles interstate, and in which sources of P. ramorum inoculum are detected on nursery stock, or in soil, growing media, pots used for nursery stock, standing water, drainage water, water used for irrigation, or any other regulated, restricted, or associated articles at the nursery.

• We instituted inspection and sampling protocols for regulated establishments.

• We implemented restrictions on the interstate movement of regulated, restricted, and associated articles from regulated establishments.

• We revised the inspection and sampling protocol for nurseries in quarantined areas, as well as the conditions for interstate movement of regulated, restricted, and associated articles from certain of those nurseries.

We are proposing to update the regulations to reflect the changes made by the Federal Orders to the Phytophthora ramorum domestic quarantine program. Additionally, we are proposing to update the lists of regulated and associated articles for P. ramorum, and establish conditions for the interstate movement of soil samples from areas quarantined for P. ramorum.

Below, we discuss these amendments to the regulations at greater length.

As we mentioned earlier in this document, paragraph (b) of § 301.92-3 lists areas designated as regulated areas for Phytophthora ramorum. Proposed paragraph (b) would provide conditions for the designation and deregulation of regulated establishments. Specifically, it would state that the Administrator would designate a nursery that is not located in a quarantined area for P. ramorum as a regulated establishment for P. ramorum if the nursery ships regulated, restricted, or associated articles interstate and sources of P. ramorum are detected on nursery stock, or in soil, growing media, pots used for nursery stock, standing water, drainage water, water used for irrigation, or any other regulated, restricted, or associated articles at the nursery. It would also state that the Administrator would withdraw regulation of a regulated establishment if, for 3 consecutive years, each time the nursery is inspected by an inspector, it is found free of sources of P. ramorum inoculum. We discuss the inspection and sampling protocols for regulated establishments later in this document.

Currently, paragraph (d) of § 301.92-4 contains conditions for interstate movement of both regulated and non-host nursery stock from a regulated area for Phytophthora ramorum. Proposed paragraph (d) would contain conditions for the movement of regulated, restricted, and associated articles from regulated establishments. In order for such articles to be moved interstate, the regulated establishment would have to enter into a compliance agreement with APHIS, and the articles would have to be accompanied by a certificate issued in accordance with § 301.92-5. We are also proposing to amend the heading of the section so that it is clear that it contains conditions for the interstate movement of regulated, restricted, and associated articles from regulated establishments.

Within § 301.92-5, paragraph (b) contains conditions for the issuance of certificates for regulated articles of nursery stock, associated articles, and non-host nursery stock from nurseries in regulated areas. Proposed paragraph (b) would contain conditions for the issuance of certificates for regulated, restricted, and/or associated articles from regulated establishments. Under the proposal, in order for a certificate to be issued for such articles, an inspector would have to determine that the nursery entered into a compliance agreement with APHIS and abided by all terms and conditions of that compliance agreement, the nursery had been inspected in accordance with the inspection and sampling protocols specified in § 301.92-11, the articles to be shipped interstate are free from P. ramorum inoculum, and the movement of the articles would not be subject to additional restriction under the PPA or other Federal domestic plant quarantines and regulations.

Within § 301.92-11, paragraph (c) contains inspection and sampling protocols for nurseries in regulated areas that ships regulated articles of nursery stock or associated articles interstate. Proposed paragraph (c) would contain inspection and sampling protocols for regulated establishments shipping regulated, restricted, or associated articles interstate.

Specifically, proposed paragraph (c) would require that regulated establishments be inspected at least twice annually for symptoms of P. ramorum infestation by an inspector. The inspection would focus on regulated plants and other potential sources of P. ramorum inoculum. Additionally, during such inspections, samples would be taken from host plants, soil, standing water, drainage water, water for irrigation, growing media, and any other articles determined by the inspector to be possible sources of P. ramorum inoculum. The number of samples taken could vary depending on the possible sources of P. ramorum identified at the nursery, as well as the number of host articles in the nursery. Finally, samples would be labeled and sent for testing to a laboratory approved by APHIS in accordance with the regulations.

If all samples tested returned negative results for P. ramorum, an inspector could certify that the nursery is free of P. ramorum at the time of the inspection, and all regulated, restricted, and associated articles at the nursery would be considered free from P. ramorum inoculum for purposes of § 301.92-5(b) until the time of the next inspection. Additionally, as we mentioned previously in this document, if, for 3 consecutive years, the nursery is determined to be free of sources of P. ramorum inoculum each time it is inspected by an inspector, it would be deregulated.

If any samples tested return positive results for P. ramorum, the nursery could ship lots of regulated, restricted, or associated articles interstate under a certificate only if the lot is determined to be free from P. ramorum inoculum. (In other words, the articles at the nursery are not presumed to be free from P. ramorum inoculum because of the positive samples, and would be evaluated on a lot-by-lot basis.) The method for this determination would be specified within the nursery's compliance agreement with APHIS.

Paragraph (d) of § 301.92-11 contains an inspection and sampling protocol for nurseries in regulated areas for P. ramorum that ship non-host nursery stock interstate, and do not contain regulated or associated articles. Because we are proposing to remove regulated areas from the regulations, and nurseries that only contain and ship interstate non-host nursery stock would not be designated as regulated establishments, we are proposing to remove the inspection and sampling protocol contained in paragraph (d) of § 301.92-11 from the regulations.

We are also proposing to make several harmonizing changes to other sections of the regulations to reflect the removal of regulated areas for P. ramorum and implementation of regulated establishments for P. ramorum.

Section 301.92 contains general restrictions on the interstate movement of regulated, restricted, and associated articles, as well as other nursery stock. Paragraph (b) of § 301.92 states that no person may move nursery stock interstate from a nursery in a regulated area for P. ramorum except in accordance with the regulations. Proposed paragraph (b) would specify that no person may move restricted, regulated, or associated articles from a regulated establishment except in accordance with the regulations.

Currently, paragraph (c) of § 301.92 states that no person may move regulated, restricted, or associated articles interstate from a quarantined or regulated area for P. ramorum if the articles have been tested with a test approved by APHIS and found infected with P. ramorum, or if the articles are part of a plant that was found infected with P. ramorum, unless the articles are moved in accordance with 7 CFR part 330 (i.e., our regulations governing the interstate movement of plant pests). Proposed paragraph (c) would prohibit the interstate movement from quarantined areas or regulated establishments of articles that have been found infected with P. ramorum or that are part of a plant that has been found infected with P. ramorum.

Section 301.92-1 contains definitions of terms used in the regulations. The section includes a definition of regulated area. Since that term is no longer used in the P. ramorum domestic quarantine program, we are proposing to remove the definition from § 301.92-1. We are also proposing to add a definition of regulated establishment to § 301.92-1. The definition would state that a regulated establishment is any nursery regulated by APHIS pursuant to paragraph (b) of § 301.92-3 of the regulations.

As we mentioned earlier in this document, paragraph (a) of § 301.92-11 contains an inspection and sampling protocol for nurseries in quarantined areas for P. ramorum that ship regulated nursery stock interstate, while paragraph (b) of § 301.92-11 contains an inspection and sampling protocol for nurseries in quarantined areas for P. ramorum that ship non-host nursery stock interstate.

Proposed paragraph (a) would contain two separate inspection and sampling protocols. Pursuant to the January 2014 Federal Order, if P. ramorum has not been discovered at the nursery since March 31, 2011, the inspection and sampling protocol for the nursery would be substantially similar to the one currently stated in the regulations. The only change would be the minimum number of samples that would be tested at the nursery: Whereas the regulations provide for a minimum of 40 samples, under the Federal Order the minimum number of samples is set on a nursery-by-nursery basis depending on the amount of regulated, restricted, and associated articles at the nursery. We are proposing to revise paragraph (a) to align the regulations with changes made by the Federal Order.

Proposed paragraph (a) would also provide that if, however, P. ramorum has been discovered at the nursery since March 31, 2011, the nursery would be subject to the same inspection and sampling protocol as that specified for regulated establishments. Unlike regulated establishments, however, if a nursery in a quarantined area is tested and found free of P. ramorum inoculum for 3 consecutive years, it would not be released from regulation, but rather reverted to the previous inspection and sampling protocol.

We are proposing minor revisions to paragraph (b) of § 301.92-11 to reflect these changes to paragraph (a).

We are also proposing to make one additional amendment to § 301.92-11. The introductory text to the section contains a table to aid nurseries in determining what inspection and sampling protocol they are subject to. One of the primary purposes of the table is to delineate the different inspection and sampling protocols for regulated areas, which is no longer necessary. Another primary purpose of the table is to clarify that inspection and sampling protocols for nurseries in quarantined areas differed based on whether the nursery ships regulated nursery stock interstate. This is no longer necessarily the case; a nursery in a quarantined area for P. ramorum that ships only regulated nursery stock interstate would be subject to the same inspection and sampling protocol as a nursery that ships non-host nursery stock interstate if P. ramorum had not been discovered at the nursery since March 31, 2011. For these reasons, we are proposing to remove the table from the regulations.

As we mentioned earlier in this document, § 301.92-12 of the regulations contains approved tests and testing protocols for P. ramorum. Paragraph (a) is written in a manner which considers all samples tested for P. ramorum using an optional ELISA prescreening to be plants or plant products. As a result of our proposed revisions to § 301.92-11, samples tested using an optional ELISA prescreening may not always be from plants or plant products; for example, they may come from standing water or water used for irrigation. Therefore, we are proposing to revise paragraph (a) of § 301.92-12 accordingly.

As we mentioned previously in this document, § 301.92-2 of the regulations designates nursery stock of proven host taxa for P. ramorum as regulated articles for P. ramorum. It also designates nursery stock of taxa associated with P. ramorum, but not proven to be hosts, as associated articles for P. ramorum. We are proposing to add Cinnamomum camphora and Gaultheria procumbens to the list of regulated articles, and Ilex cornuta, Illicium parviflorum, Larix kaempferi, Magnolia denudata, Mahonia nervosa, Molinadendron sinaloense, Trachelospermum jasminoides, and Veronica spicata Syn. Pseudolysimachion spicatum to the list of associated articles.

As we mentioned previously in this document, paragraph (a) of § 301.92-4 provides conditions for the interstate movement of regulated articles from quarantined areas for P. ramorum. Paragraph (a)(2) of that section provides conditions for the interstate movement of regulated articles without a certificate.

On June 1, 2016, we issued a Federal Order 2 authorizing the interstate movement of soil samples for chemical or physical (compositional analysis) from quarantined areas for P. ramorum without a certificate, provided that they are moved to a laboratory, and that laboratory:

• Has entered into and is operating under a compliance agreement with APHIS in accordance with § 301.92-6;

• Is abiding by all terms and conditions of that compliance agreement; and

• Is approved by APHIS to test and/or analyze such samples.

We are proposing to amend paragraph (a)(2) of § 301.92-4 based on the provisions of this Federal Order.

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. This proposed rule is not expected to be an Executive Order 13771 regulatory action because this proposed rule is not significant under Executive Order 12866. Further, APHIS considers this rule to be a deregulatory action under Executive Order 13771 as the action would remove regulated areas for P. ramorum from the regulations, as well as the regulatory requirements specific to such areas, thus relieving restrictions on affected entities located in those areas.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov website (see ADDRESSES above for instructions for accessing Regulations.gov).

This proposed rule would revise the P. ramorum domestic regulations to accord with Federal Orders issued 2013-2016. The Federal Orders have allowed APHIS and State regulatory agencies to focus regulatory controls on the nurseries that present a significant risk of spreading the pathogen and away from those nurseries that pose a negligible risk of contributing to its artificial spread, thereby more efficiently apportioning resources and regulatory burden.

This proposed rule would remove the designation of P. ramorum regulated areas, as well as all restrictions and protocols specific to those areas. It would relieve the regulatory burden on approximately 1,500 nurseries where the disease is not present in the environment. As an alternative to regulated areas, this action would codify the concept of regulated establishments that would be required to enter into compliance agreement with APHIS.

The annual cost of complying with the P. ramorum management requirements in the regulations averages about $15,000 per nursery. Thus, the cost savings for the 1,500 operations relieved of these management requirements totals $22.5 million per year. In addition, by not requiring annual certification by APHIS or State officials, there are public cost savings of $252,000.

This rule would not deregulate the current P. ramorum quarantined areas, nor would it deregulate interstate shipping nurseries located within these quarantined areas. For regulated establishments and establishments located within quarantined areas, compliance costs may increase or decrease depending on amended best management practices, but any related change in operational costs is not expected to be significant. The majority of establishments affected by this rule are small entities.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and third party disclosure requirements included in this proposed rule have already been approved by the Office of Management and Budget (OMB) under OMB control numbers 0579-0088 and 0579-0310.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

Accordingly, we propose to revise 7 CFR part 301 as follows:

The revision reads as follows:

The addition reads as follows:

The additions read as follows:

The revisions read as follows:

Comments Invited

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 ask that you send us two copies of written comments.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.

On August 4, 2016, Ultramagic S.A. (Ultramagic) applied for a change to Type Certificate (TC) No. B02CE 1 to include new basket Model no. CV-08 for balloon Models M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105. The CV-08 basket consists of a traditionally constructed basket, but incorporates seats with restraints and trays for all passengers, as well as a lower basket sidewall to offer a panoramic view for passengers. The CV-08 basket will be matched with one of the balloon envelopes associated with the balloon models listed in these special conditions. The volume of hot air, gores, maximum diameter, and total height defines the balloon envelope.

Most balloon baskets accommodate standing passengers. The CV-08 differs by incorporating passenger seats, restraints, and a lower basket sidewall. Due to the lower sidewall and seat configuration, passengers would need to remain seated and restrained with safety belts during flight. This configuration should consider the static strength of the installations, the possible loads in an accident, and the effect on passenger safety. Accident impact should consider safety comparison between a restrained, sitting occupant; and a normal, standing occupant. Safety requirements for balloon-seated occupants are not included in the existing airworthiness regulations. These proposed special conditions evaluate the seat installations and restraints using methods consistent with special conditions issued by the European Aviation Safety Agency (EASA). The EASA special conditions are based upon a German standard for seats in hot air airships.

Under the provisions of § 21.101, Ultramagic must show that the M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105 balloon models—coupled with the CV-08 basket—continues to meet the applicable provisions of the regulations incorporated by reference in TC No. B02CE or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in TC No. B02CE are as follows:

14 CFR 21.29 and part 31, effective on January, 1990, as amended by 31-1 through 31-5 inclusive.

Equivalent level of Safety findings per provision of 14 CFR 21.21(b)(1):

Special Conditions 31-001-SC applicable to MK-32 model burners.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 31) do not contain adequate or appropriate safety standards for the balloon models listed in these proposed special conditions 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(s) 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, or should any other model already included on the same type certificate be modified to incorporate the same or similar novel or unusual design feature, the FAA would apply these special conditions to the other model under § 21.101.

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 M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105 balloon models coupled with a CV-08 basket will incorporate the following novel or unusual design features:

Occupant seats with restraints and a lowered basket side rail.

Neither the FAA's airworthiness standards (14 CFR part 31, amendment 31-5), nor EASA's current Certification Specification (CS) for Hot Air Balloons (CS 31HB, amendment 1), incorporate specific requirements for seat and seat belts.

EASA previously published a proposed special condition 2 (now expired) for seats and seat belts for hot air balloon baskets. EASA based the requirements of its proposed special condition on the German airworthiness requirements for Hot Air Airships LFHLLS,3 incorporating hot air balloon basket requirements for seats, seat belts, and the loads in an emergency landing condition, similar to hot air airship requirements. Ultramagic's change application applied the language in the EASA proposed special condition for CS 31HA.14(c), “Occupant mass,” CS 31HA.43(d), “Fitting factor,” CS 31HA.561(a) and (b)(1), “Emergency landing conditions—General,” and CS 31HA.785(a), (c), and (d), “Seats and seat belts” to the CV-08 basket. The FAA finds that these standards are appropriate for a seated, restrained occupant.

As discussed above, these special conditions are applicable to the Model M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105 balloons. Should Ultramagic apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the FAA would apply these special conditions to that model as well.

This action affects only certain novel or unusual design features on the balloon models specified in these special conditions. 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. These proposed special conditions are identical in intent to the EASA special conditions, although the formatting has been altered to meet these special condition requirements.

The authority citation for these special conditions is as follows:

Accordingly, the FAA proposes the following special conditions as part of the type certification basis for Ultramagic S.A. Model M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105 balloons with a basket Model no. CV-08.

For calculation purposes, it should be assumed the mass of an occupant is at least 86 kilograms (190 pounds).

For each seat, safety belt, and harness, its attachment to the structure must be shown, by analysis, tests, or both, to be able to withstand the inertia forces prescribed in paragraph (c) of these special conditions multiplied by a fitting factor of 1.33.

The balloon—although it may be damaged under emergency landing conditions—must be designed to give each occupant every reasonable chance of avoiding serious injury in a crash landing—when seat belts provided for in the design are properly used—and the occupant is subject to the following ultimate inertia forces acting relative to the surrounding structure as well as independently of each other.

(1) Each seat and its supporting structure must be designed for an occupant mass in accordance paragraph (a) of these special conditions and for the maximum load factors corresponding to the specified flight and ground load conditions, including the emergency landing conditions prescribed in paragraph (c) of these special conditions.

(2) Each seat or berth shall be fitted with an individual approved seat belt or harness.

(3) Seat belts installed on the balloon must not fail under flight or ground load conditions or emergency landing conditions in accordance with paragraph (c) of these special conditions, taking into account the geometrical arrangement of the belt attachment and the seat.

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0406; Product Identifier 2013-NE-30-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

We issued AD 2017-07-04, Amendment 39-18842 (82 FR 16728, April 6, 2017), (“AD 2017-07-04”), for GE GE90-110B1 and GE90-115B turbofan engines with certain HPC rotor stage 2-5 spools installed. AD 2017-07-04 requires removing these spools from service at times determined by a drawdown plan. AD 2017-07-04 resulted from reports of cracks in HPC rotor stage 2-5 spool aft spacer arms. We issued AD 2017-07-04 to prevent failure of a critical life-limited rotating engine part, which could result in an uncontained engine failure and damage to the airplane.

Since we issued AD 2017-07-04, GE released GE SB GE90-100 SB 72-0714 R01, dated February 16, 2018, for the HPC rotor stage 2-5 spools, which increases the number of affected parts.

Additionally, GE and Boeing provided comments on AD-2017-07-04 that some HPC rotor stage 2-5 spools listed in AD 2013-24-17 (superseded by AD 2017-07-04), were omitted from AD 2017-07-04.

We reviewed GE SB GE90-100 SB 72-0499 R01, dated February 5, 2014; GE SB GE90-100 SB 72-0659 R01, dated February 18, 2016; and GE SB GE90-100 SB 72-0714 R01, dated February 16, 2018.

GE SB GE90-100 SB 72-0499 R01 describes procedures for identification and removal from service of HPC rotor stage 2-5 spools that use the original seal tooth coating process. GE SB GE90-100 SB 72-0659 R01 describes procedures for identification and removal from service of HPC rotor stage 2-5 spools that use a modified seal tooth coating process. GE SB GE90-100 SB 72-0714 R01 describes procedures for identification and removal from service of HPC rotor stage 2-5 spools that use the modified seal tooth coating process, without coating between the seal teeth.

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

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

This proposed AD would retain all requirements of AD 2017-07-04. This proposed AD would require removing certain HPC rotor stage 2-5 spools from service at times specified in the required actions section.

We estimate that this proposed AD affects 85 engines installed on airplanes of U.S. registry.

We estimate the following costs to comply with this proposed AD:

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

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

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

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

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

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

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

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

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

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

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0552; Product Identifier 2018-NM-049-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this NPRM.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0051, dated March 2, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Defense and Space S.A. Model C-212-CB, C-212-CC, C-212-CD, C-212-CE, and C-212-DF airplanes. The MCAI states:

Corrective actions include obtaining corrective actions approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus Defense and Space S.A.'s EASA Design Organization Approval (DOA); and accomplishing the corrective actions within the compliance time specified therein. You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0552.

This NPRM does not propose to supersede AD 2017-19-08. Rather, we have determined that a stand-alone AD would be more appropriate to address the changes in the MCAI. This proposed AD would require repetitive detailed visual inspections of the rudder pedal control system support box and shaft and applicable corrective actions. Accomplishment of the proposed actions would then terminate all of the requirements of AD 2017-19-08.

Airbus Defense and Space S.A. has issued Airbus Alert Operators Transmission AOT-C212-27-0002, dated February 28, 2018. The service information describes procedures for repetitive detailed visual inspections of the rudder pedal control system support box and shaft. 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 product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We estimate that this proposed AD affects 36 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

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

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

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Issued in Des Moines, Washington, on June 14, 2018.

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0479; Product Identifier 2016-NE-23-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

We issued AD 2018-02-14, Amendment 39-19167 (83 FR 3263, January 24, 2018), (“AD 2018-02-14”), for certain Honeywell TPE331 turboprop and TSE331 turboshaft engines. AD 2018-02-14 requires inspection of the affected combustion chamber case assembly, replacement of those assemblies found cracked, and removal of affected assemblies on certain TPE331 and TSE331 engines. AD 2018-02-14 resulted from reports that combustion chamber case assemblies have cracked and ruptured. We issued AD 2018-02-14 to prevent failure of the combustion chamber case assembly.

Since we issued AD 2018-02-14, we determined the need to revise sections of that AD. We received comments indicating that the TPE331-12B engine model was inadvertently omitted from that AD and that the TPE331-43-A, -43-BL, -47-A, -55-B, and -61-A engine models included typographical errors. We also received comments to revise the Compliance section, which disallows weld repairs on any combustion chamber case assemblies that are affected by that AD. We determined that allowing weld repair procedures of certain combustion chamber case assemblies with lower stresses may be accomplished if these procedures are approved by the Manager, Los Angeles ACO Branch.

We reviewed Honeywell Service Bulletin (SB) TPE331-72-2178, Revision 0, dated May 3, 2011 and Honeywell SB TPE331-72-2179, Revision 0, dated May 3, 2011. Honeywell SB TPE331-72-2178, Revision 0, describes procedures for inspection and removal of the affected combustion chamber case assemblies installed on all affected engines except for the TPE331-12B engine model. Honeywell SB TPE331-72-2179, Revision 0, describes procedures for inspection and removal of the affected combustion chamber case assemblies installed on the TPE331-12B engine model. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We reviewed Honeywell SBs TPE331-72-2228, Revision 0, dated June 12, 2014; TPE331-72-2230, Revision 0, dated June 19, 2014; TPE331-72-2218, Revision 2, dated February 18, 2017; TPE331-72-2244, Revision 2, dated March 20 2017; TPE331-72-2235, Revision 2, dated February 18, 2017; TPE331-72-2281, Revision 0, dated July 22, 2016; TPE331-72-2294, Revision 0, dated December 22, 2016; TPE331-72-2231, Revision 1, dated August 1, 2017; and TSE331-72-2245, Revision 0, dated November 11, 2016. These SBs provide guidance on replacement of the affected combustion chamber case assemblies.

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

This proposed AD would retain all of the requirements of AD 2018-02-14. This proposed AD would revise the Applicability to include the TPE331-12B engine model and to correct references to the TPE331-43-A, -43-BL, -47-A, -55-B, and -61-A engine models. This proposed AD would also allow weld repair procedures to the applicable combustion chamber case assemblies provided those procedures are approved by the Manager, Los Angeles ACO Branch.

We estimate that this AD affects 5,644 engines installed on airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We estimate that 158 engines will need this replacement during the first year of inspection.

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

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

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

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

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

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

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

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

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

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

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

Table 1 lists the rules addressed by this proposal with the dates when they were adopted by the SDAPCD and submitted by the California Air Resources Board (CARB), which is the governor's designee for California SIP submittals. Collectively, these submittals generally constitute the SDAPCD's current program for preconstruction review and permitting of new or modified stationary sources under its jurisdiction. The rule revisions that are the subject of this action represent a comprehensive revision to the SDAPCD's preconstruction review and permitting program and are intended to satisfy the requirements under part D of title I of the Act (nonattainment NSR or NNSR) as well as the general preconstruction review requirements under section 110(a)(2)(C) of the Act (minor NSR). The SDAPCD does not implement a SIP-approved prevention of significant deterioration (PSD) permitting program and has not submitted the rules in this action for purposes of the PSD program; therefore, we are not evaluating whether this SIP submittal satisfies PSD program requirements at 40 CFR 51.166.

On October 14, 2016, the EPA determined that the submittal of Rules 20.1, 20.2, 20.3, 20.4 and 20.6 met the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review. On September 27, 2016, we determined that the submitted versions of Rules 11 and 24 met these completeness criteria. On May 21, 1987, the submittal of Rule 20 was deemed complete by operation of law.

In addition to these SIP submittals, on April 27, 2018 the District and CARB transmitted a commitment letter to the EPA to adopt and submit specific enforceable measures by July 31, 2019 to address deficiencies in the submitted rules identified by the EPA.1

The EPA last approved significant revisions or updates to the SDAPCD's SIP-approved NSR program in the 1980s. The existing SIP-approved NSR program for new or modified stationary sources under the SDAPCD's jurisdiction generally consists of the versions of the rules identified below in Table 2.

Collectively, these regulations establish the NSR requirements that are currently in place for both major and minor stationary sources under the SDAPCD's jurisdiction in California. If the EPA finalizes the action proposed herein, these rules will be replaced in the SIP by the submitted set of rules listed in Table 1.

As noted above and described in further detail below, the submitted rules are intended to satisfy the minor NSR and NNSR requirements of section 110(a)(2)(C) and part D of title I of the Act, and related EPA regulations. Minor NSR requirements are generally applicable for SIPs in all areas, while NNSR requirements apply only for areas designated as nonattainment for one or more National Ambient Air Quality Standards (NAAQS). San Diego County is currently classified as a “moderate” nonattainment area for the 2008 8-hour ozone NAAQS and is designated attainment or unclassifiable for all other NAAQS. See 40 CFR 81.305. Therefore, in addition to being subject to the requirements for minor NSR at section 110(a)(2)(C) of the Act, California is required to adopt and implement a SIP-approved NNSR permitting program that applies to new or modified major stationary sources of ozone and ozone precursors within the San Diego County nonattainment area, under part D of title I of the Act.

The EPA has evaluated the submitted rules for compliance with applicable requirements of section 110(a)(2)(C) and part D of title I of the CAA and associated regulations at 40 CFR 51.160-165, consistent with the District's current classification as a “moderate” nonattainment area for the 2008 8-hour ozone NAAQS. We have also reviewed the rules for consistency with other CAA general requirements for SIP submittals, including requirements at section 110(a)(2) regarding rule enforceability, and requirements at sections 110(l) and 193 for SIP revisions.

Section 110(a)(2)(C) of the Act requires each SIP to include a program to regulate the modification and construction of any stationary source within the areas covered by the SIP as necessary to assure attainment and maintenance of the NAAQS. The EPA's regulations at 40 CFR 51.160-51.164 provide general programmatic requirements to implement this statutory mandate. These requirements, commonly referred to as the “minor NSR” or “general NSR” program, apply generally to both major and non-major stationary sources and modifications and in both attainment and nonattainment areas, in contrast to the specific statutory and regulatory requirements for PSD and NNSR permitting programs under parts C and D of title I of the Act that apply to major sources in attainment and nonattainment areas, respectively.

Part D of title I of the Act, and the implementing regulations at 40 CFR 51.165, contain the NNSR program requirements for major stationary sources and major modifications (as those terms are defined at 40 CFR 51.165) at facilities that are located in a nonattainment area and are major sources for the pollutants for which the area has been designated nonattainment.

The SDAPCD has elected not to submit rules to satisfy requirements of the PSD program under part C of title I of the Act for major stationary sources in attainment areas at this time. Accordingly, the EPA is not evaluating whether this SIP submittal satisfies PSD program requirements at 40 CFR 51.166, and some portions of Rules 20.2-20.4 addressing major sources in attainment areas are excluded from the submittal. See Table 1. The EPA remains the PSD permitting authority in San Diego County.

Section 110(a)(2)(A) of the Act requires that regulations submitted to the EPA for SIP approval must be clear and legally enforceable. Section 110(l) of the Act prohibits the EPA from approving any SIP revisions that would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the CAA. Section 193 of the Act prohibits the modification of a SIP-approved control requirement in effect before November 15, 1990 in a nonattainment area, unless the modification ensures equivalent or greater emission reductions of the relevant pollutant(s). With respect to procedures, CAA sections 110(a) and 110(l) require that a state conduct reasonable notice and hearing before adopting a SIP revision.

With the exceptions noted below, the EPA finds that the submitted rules generally satisfy the applicable CAA and regulatory requirements. Accordingly, we are proposing to fully approve Rules 11, 20, and 24 under CAA section 110(k)(3), and to conditionally approve Rules 20.1, 20.2, 20.3, 20.4, and 20.6 under CAA section 110(k)(4). Below, we discuss generally our evaluation of the submitted rules. The technical support document (TSD) included in the docket for this proposed rulemaking contains a more detailed analysis.

We find that the submitted rules satisfy the minor NSR requirements. The rules clearly identify the kinds of projects subject to review under the District's program, include legally enforceable procedures to ensure that construction will not violate the state's control strategy or interfere with attainment or maintenance of the NAAQS, provide for public availability of relevant information, and meet other requirements of the minor NSR regulations at 40 CFR 51.160-164. In general, Rules 11, 20, 20.1, 20.6 and 24 incorporate general regulatory requirements of the minor NSR program, while Rules 20.2, 20.3, and 20.4 apply applicable elements of the program to minor stationary sources, major stationary sources, and portable emission units, respectively.

We find that the submitted rules satisfy nearly all applicable statutory and regulatory NNSR requirements, including definitions, applicability procedures, and requirements for sources in nonattainment areas to obtain emission reduction offsets and comply with the lowest achievable emissions rate. These requirements are met substantially through Rule 20.1, and other elements are addressed in Rules 20.2-20.4. The EPA has identified two deficiencies in the rules. First, the submitted rules do not contain recordkeeping and reporting requirements for sources using an actual-to-potential-actual test to determine applicability of major source requirements. The submitted Rule 20.1 provides an option for sources to use the federal actual-to-potential-actual test under 40 CFR 51.165(a)(2)(ii)(B) through (F); however, the rule does not include associated provisions at 40 CFR 51.165(a)(6) and (7) that require these sources to comply with recordkeeping and reporting requirements. Second, the rules do not incorporate the requirement at section 173(a)(4) of the Act, which states that NNSR permit programs shall provide that permits to construct and operate may not be issued if the EPA Administrator has determined that the applicable implementation plan for the nonattainment area is not being adequately implemented. As described below, these deficiencies are the basis for the EPA's proposed conditional approval of the District's June 17, 2016 submittal.

The submitted rules comply with the substantive and procedural requirements of CAA section 110(l). With respect to the procedural requirements, based on our review of the public process documentation included with the submitted rules, we find that the SDAPCD has provided sufficient evidence of public notice and opportunity for comment and public hearings prior to submittal of this SIP revision and has satisfied these procedural requirements under CAA section 110(l).

With respect to the substantive requirements of CAA section 110(l), we have determined that our approval of the submitted rules would strengthen the applicable SIP. The current SIP-approved San Diego NNSR program is significantly out of date when compared with current federal NNSR regulatory requirements, and the updated versions of the submitted rules bring the program up to date with current requirements. As a whole, the submitted rules are more stringent and will be more protective of air quality in San Diego County, and we have determined that our approval of this SIP submittal would not interfere with any applicable requirement concerning attainment and RFP or any other applicable requirement of the Act.

Similarly, we find that the submitted rules are approvable under section 193 of the Act. Most of the submitted rules were last approved prior to November 15, 1990, and are subject to the general requirement to ensure equivalent or greater emission reductions. We have determined that the submitted rules will ensure greater reductions overall relative to the SIP-approved version of the rules.

The submitted rules are otherwise consistent with criteria for the EPA's approval of regulations submitted for inclusion in the SIP, including the requirement at CAA section 110(c)(2)(A) that submitted regulations be clear and legally enforceable.

For the reasons stated above and explained further in our TSD, we find that the submitted NSR rules generally satisfy the applicable CAA and regulatory requirements for minor NSR and NNSR permit programs under CAA section 110(a)(2)(C) and part D of title I of the Act and other applicable requirements, subject to the two exceptions noted above where the EPA has identified a deficiency. For those exceptions, the District and CARB have committed to adopt and submit revisions to address the identified deficiencies within a year of the date of approval, consistent with the requirements at CAA section 110(k)(4) for conditional approval.

Based on our evaluation of the submitted rules, the EPA is proposing to fully approve the SDAPCD's August 22, 2016 and November 21, 1986 submittals (consisting of Rules 11, 20, and 24), and to conditionally approve the District's June 17, 2016 submittal (consisting of Rules 20.1, 20.2, 20.3, 20.4, and 20.6). Under CAA section 110(k)(3), the EPA may approve a plan revision in whole or in part if it meets all applicable requirements. Under CAA section 110(k)(4), the EPA may conditionally approve a plan revision based on a commitment by the state to adopt specific enforceable measures by a date certain but not later than one year after the date of the plan approval.

As described above, the EPA has determined that the submitted rules generally comply with most applicable requirements, but do not satisfy the requirements at 40 CFR 51.165(a)(6) and (7) and section 173(a)(4) of the Act. On April 16, 2018, the District transmitted to CARB and the EPA a commitment to revise the submitted rules by amending Rule 20.1 to incorporate the requirements at 40 CFR 51.165(a)(6) and (7) and by amending Rule 20.3 to incorporate the requirement at CAA section 173(a)(4), and to transmit the revised rules to CARB no later than June 30, 2019. The amendments to Rules 20.1 and 20.3 as described above will cure the deficiencies in Rules 20.2, 20.4, and 20.6. On April 27, 2018, CARB committed to submit these rules to the EPA no later than July 31, 2019. These letters commit the District to adopt specific enforceable measures to correct the rule deficiencies and commit the state to submit them to the EPA by a date certain, and the EPA has determined that if the District adopts and submits these revisions as committed, the identified deficiencies will be cured. Accordingly, we find that these commitment letters are consistent with CAA requirements regarding conditional approval at CAA section 110(k)(4).

The intended effect of our proposed conditional approval action is to update the applicable SIP with current SDAPCD rules and provide the SDAPCD the opportunity to correct the identified deficiencies. If we finalize this action as proposed, our action would be codified through revisions to 40 CFR 52.220 (Identification of plan—in part) and 40 CFR 52.248 (Identification of plan—conditional approval).

If the State meets its commitment to submit the required measures and the EPA approves the submission, then the deficiencies listed above will be cured. However, if the District fails to submit these revisions within the required timeframe, the conditional approval will become a disapproval, and the EPA will issue a finding of disapproval. The EPA is not required to propose the finding of disapproval. Further, a finding of disapproval would start an 18-month clock to apply sanctions under CAA section 179(b) and a two-year clock for a federal implementation plan under CAA section 110(c)(1).

We will accept comments from the public on this proposal until July 25, 2018.

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

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

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

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

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

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

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

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

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

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

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

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

Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

EPA is proposing to approve MDNR's request to change the designation of the Missouri portion of the St. Louis area from nonattainment to attainment for the 2008 ozone NAAQS, based on quality-assured and certified data monitoring data for 2013-2015, and that the Missouri portion of the St. Louis area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA.

EPA is also proposing to approve the state's maintenance plan as a revision to the Missouri SIP; the maintenance plan is designed to keep the Missouri portion of the St. Louis area in attainment of the 2008 ozone NAAQS through 2030.

Finally, EPA finds adequate and is proposing to approve into the SIP the newly-established 2030 MVEBs for the area. The adequacy comment period for the MVEBs began on April 10, 2018, with EPA's posting of the availability of Missouri's submittal on EPA's Adequacy website (at https://www.epa.gov/state-and-local-transportation/adequacy-review-state-implementation-plan-sip-submissions-conformity). The adequacy comment period for these MVEBs ended on May 10, 2018. EPA did not receive any adverse comments on this submittal during the adequacy comment period. In a letter dated May 15, 2018, EPA informed Missouri that the 2030 MVEBs are adequate for use in transportation conformity analyses. Please see section V.B. of this rulemaking, “What is the status of EPA's adequacy determination for the proposed VOC and NOX MVEBs for the St. Louis area?” for further explanation of this process.

EPA has determined that ground-level ozone is detrimental to human health. On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the three-year average of the annual fourth highest daily maximum 8-hour average concentration is equal to or less than 0.075 ppm at all of the ozone monitoring sites in the area. See 40 CFR 50.15 and appendix P to 40 CFR part 50.

Upon promulgation of a new or revised NAAQS, section 107(d)(1)(B) of the CAA requires EPA to designate as nonattainment any areas that are violating the NAAQS based on the most recent three years of quality assured ozone monitoring data. The St. Louis area was designated as a marginal nonattainment area for the 2008 ozone NAAQS on May 21, 2012 (77 FR 30088); the designation became effective on July 20, 2012.

In a final implementation rule for the 2008 ozone NAAQS (SIP Requirements Rule),1 EPA established ozone standard attainment dates based on table 1 of CAA section 181(a). For the areas classified as marginal nonattainment, this established an attainment date three years after the July 20, 2012 effective date.

CAA section 181(b)(2) requires EPA to determine, based on an area's ozone design value as of the area's attainment deadline, whether the area has attained the ozone standard by that date. The statute provides a mechanism by which states that meet certain criteria may request, and be granted by the Administrator, a one year extension of an area's attainment deadline. On May 4, 2016, based on EPA's evaluation and determination that the areas met the criteria of CAA section 181(a)(5), EPA granted the St. Louis area a one year extension of the marginal area attainment date; the revised attainment date became July 20, 2016. 81 FR 26697.

On June 27, 2016, in accordance with CAA section 181(b)(2)(A) and the provisions of the SIP Requirements Rule, EPA determined that the St. Louis area attained the 2008 8-hour ozone standard by its July 20, 2016, attainment date. 81 FR 41444. EPA's determination was based upon three years of complete, quality assured and certified data for the 2013-2015 time period.

On September 12, 2016, with a supplemental revision on February 16, 2018, Missouri submitted to EPA a request to redesignate the Missouri portion of the St. Louis area, to attainment for the 2008 ozone NAAQS, and to approve the maintenance plan for that area, including the 2030 MVEBs, as a revision to the SIP.

Section 107(d)(3)(E) of the CAA allows redesignation of a nonattainment area to attainment of the NAAQS provided that: (1) The Administrator determines that the area has attained the NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP, applicable Federal air pollutant control regulations, and other permanent and enforceable emission reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA; and (5) the state containing the area has met all requirements applicable to the area for the purposes of redesignation under section 110 and part D of the CAA.

On April 16, 1992, EPA provided guidance on redesignations in the General Preamble for the Implementation of Title I of the CAA Amendments of 1990 (57 FR 13498) and supplemented this guidance on April 28, 1992 (57 FR 18070). EPA has provided further guidance on processing redesignation requests in the following documents:

1. “Ozone and Carbon Monoxide Design Value Calculations,” Memorandum from Bill Laxton, Director, Technical Support Division, June 18, 1990;

2. “Maintenance Plans for Redesignation of Ozone and Carbon Monoxide Nonattainment Areas,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, April 30, 1992;

3. “Contingency Measures for Ozone and Carbon Monoxide (CO) Redesignations,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, June 1, 1992;

4. “Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992 (the “Calcagni Memorandum”);

5. “State Implementation Plan (SIP) Actions Submitted in Response to Clean Air Act (CAA) Deadlines,” Memorandum from John Calcagni, Director, Air Quality Management Division, October 28, 1992;

6. “Technical Support Documents (TSDs) for Redesignation of Ozone and Carbon Monoxide (CO) Nonattainment Areas,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, August 17, 1993;

7. “State Implementation Plan (SIP) Requirements for Areas Submitting Requests for Redesignation to Attainment of the Ozone and Carbon Monoxide (CO) National Ambient Air Quality Standards (NAAQS) On or After November 15, 1992,” Memorandum from Michael H. Shapiro, Acting Assistant Administrator for Air and Radiation, September 17, 1993;

8. “Use of Actual Emissions in Maintenance Demonstrations for Ozone and CO Nonattainment Areas,” Memorandum from D. Kent Berry, Acting Director, Air Quality Management Division, November 30, 1993;

9. “Part D New Source Review (part D NSR) Requirements for Areas Requesting Redesignation to Attainment,” Memorandum from Mary D. Nichols, Assistant Administrator for Air and Radiation, October 14, 1994; and

10. “Reasonable Further Progress, Attainment Demonstration, and Related Requirements for Ozone Nonattainment Areas Meeting the Ozone National Ambient Air Quality Standard,” Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, May 10, 1995.

For redesignation of a nonattainment area to attainment, the CAA section 107(d)(3)(E)(i) requires EPA to determine that the area has attained the applicable NAAQS. An area is attaining the 2008 ozone NAAQS if it meets the 2008 ozone NAAQS, as determined in accordance with 40 CFR 50.15 and appendix P of part 50, based on three complete, consecutive calendar years of quality assured air quality data for all monitoring sites in the area. To attain the NAAQS, the three-year average of the annual fourth-highest daily maximum 8-hour average ozone concentrations (ozone design values) at each monitor must not exceed 0.075 ppm. The air quality data must be collected and quality-assured in accordance with 40 CFR part 58 and recorded in EPA's Air Quality System (AQS). Ambient air quality monitoring data for the three year period must also meet data completeness requirements. An ozone design value is valid if daily maximum 8-hour average concentrations are available for at least 90 percent of the days within the ozone monitoring seasons,2 on average, for the three-year period, with a minimum data completeness of 75 percent during the ozone monitoring season of any year during the three year period. See section 2.3 of appendix P to 40 CFR part 50.

On June 27, 2016, in accordance with CAA section 181(b)(2)(A) and the provisions of the SIP Requirements Rule, EPA determined that the St. Louis area attained the 2008 ozone NAAQS by its July 20, 2016, attainment date. See 81 FR 41444. EPA's determination was based upon three years of complete, quality assured and certified data that had been recorded in AQS for the 2013-2015 time period. The data demonstrated that the St. Louis area is attaining the 2008 ozone NAAQS. The annual fourth-highest 8-hour ozone concentrations and the three-year average of these concentrations (monitoring site ozone design values) for each monitoring site are summarized in table 1.

The most recent certified, quality assured data for 2017 indicates that the area continues to attain the 2008 ozone NAAQS. If the design value of a monitoring site in the area exceeds the NAAQS after proposal, but before final approval of the redesignation, EPA will not take final action to approve the redesignation of the St. Louis area to attainment.

The three-year ozone design value for 2013-2015 is 0.071 ppm,3 which meets the 2008 ozone NAAQS. Therefore, in this action, EPA proposes to determine that the St. Louis area is attaining the 2008 ozone NAAQS.

As criteria for redesignation of an area from nonattainment to attainment of a NAAQS, the CAA requires EPA to determine that the state has met all applicable requirements under CAA section 110 and part D of title I of the CAA (see section 107(d)(3)(E)(v) of the CAA) and that the state has a fully approved SIP under CAA section 110(k) (see section 107(d)(3)(E)(ii) of the CAA). EPA proposes to find that Missouri has met all currently applicable SIP requirements for purposes of redesignation of the St. Louis area to attainment of the 2008 ozone standard under section 110 and part D of the CAA in accordance with section 107(d)(2)(E)(v). In making these proposed determinations, EPA ascertained which CAA requirements are applicable to the St. Louis area and the Missouri SIP and, if applicable, whether the required Missouri SIP elements are fully approved under section 110(k) and part D of the CAA. As discussed more fully below, SIPs must be fully approved only with respect to currently applicable requirements of the CAA.4

General SIP Requirements. Section 110(a)(2) of the CAA delineates the general requirements for a SIP. Section 110(a)(2) provides that the SIP must have been adopted by the state after reasonable public notice and hearing, and that, among other things, it must: (1) Include enforceable emission limitations and other control measures, means or techniques necessary to meet the requirements of the CAA; (2) provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to monitor ambient air quality; (3) provide for implementation of a source permit program to regulate the modification and construction of stationary sources within the areas covered by the plan; (4) include provisions for the implementation of part C prevention of significant deterioration (PSD) and part D new source review (NSR) permit programs; (5) include provisions for stationary source emission control measures, monitoring, and reporting; (6) include provisions for air quality modeling; and, (7) provide for public and local agency participation in planning and emission control rule development.

Section 110(a)(2)(D) of the CAA requires SIPs to contain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address transport of certain air pollutants.5 However, like many of the 110(a)(2) requirements, the section 110(a)(2)(D) SIP requirement is not linked with a particular area's ozone designation and classification. EPA believes that the SIP requirements linked with the area's ozone designation and classification are the relevant measures to evaluate when reviewing a redesignation request for the area. The section 110(a)(2)(D) requirements, where applicable, continue to apply to a state regardless of the designation of any one particular area within the state. Thus, EPA does not believe these requirements should be construed to be applicable requirements for the purposes of redesignation.6

In addition, EPA believes that other section 110 elements are neither connected with nonattainment plan submissions, nor linked with an area's ozone attainment status and are not applicable requirements for purposes of redesignation. The area will still be subject to these requirements after the area is redesignated to attainment for the 2008 ozone NAAQS. The section 110 and part D requirements which are linked with a particular area's designation and classification are the relevant measures to evaluate when reviewing a redesignation request. This approach is consistent with EPA's existing policy on applicability (i.e., for redesignations) of conformity and oxygenated fuels requirements, as well as with section 184 ozone transport requirements.7 EPA has reviewed Missouri's SIP revision and has concluded that it meets the general SIP requirements under section 110 of the CAA to the extent that those requirements are applicable for purposes of redesignation. On March 22, 2018 (83 FR 12496), EPA approved elements of the SIP submitted by Missouri to meet the requirements of section 110 for the 2008 ozone standard. The requirements of section 110(a)(2), however, are statewide requirements that are not linked to the ozone nonattainment status of the St. Louis area. Therefore, EPA concludes that these infrastructure requirements are not applicable requirements for purposes of review of the state's ozone redesignation request.

Part D Requirements. Section 172(c) of the CAA sets forth the basic requirements of air quality plans for states with nonattainment areas that are required to submit them pursuant to section 172(b). Subpart 2 of part D, which includes section 182 of the CAA, establishes specific requirements for ozone nonattainment areas depending on the areas' nonattainment classifications.

The Missouri portion of the St. Louis area was classified as marginal under subpart 2 for the 2008 ozone NAAQS. As such, the area is subject to the subpart 1 requirements contained in section 172(c) and section 176. Similarly, the area is subject to the subpart 2 requirements contained in section 182(a) (marginal nonattainment area requirements). A thorough discussion of the requirements contained in section 172(c) and 182 can be found in the General Preamble for Implementation of title I (57 FR 13498).

Subpart 1 Section 172 Requirements. As provided in subpart 2, for marginal ozone nonattainment areas such as the St. Louis area, the specific requirements of section 182(a) apply in lieu of the attainment planning requirements that would otherwise apply under section 172(c), including the attainment demonstration and reasonably available control measures (RACM) under section 172(c)(1), reasonable further progress (RFP) under section 172(c)(2), and contingency measures under section 172(c)(9).8

Section 172(c)(3) requires submission and approval of a comprehensive, accurate and current inventory of actual emissions. This requirement is superseded by the inventory requirement in section 182(a)(1) discussed below.

Section 172(c)(4) requires the identification and quantification of allowable emissions for major new and modified stationary sources in an area, and section 172(c)(5) requires source permits for the construction and operation of new and modified major stationary sources anywhere in the nonattainment area. EPA most recently approved Missouri's NSR program on June 4, 2015 (80 FR 31844).9 EPA has determined that, since PSD requirements will apply after redesignation, areas being redesignated need not comply with the requirement that a NSR program be approved prior to redesignation, provided that the area demonstrates maintenance of the NAAQS without part D NSR. A more detailed rationale for this view is described in the Nichols Memorandum. See also rulemakings for the Illinois portion of the St. Louis Area (77 FR 34819, 77 FR 34826, June 12, 2012); Louisville, Kentucky (66 FR 53665, 66 FR 53669, October 23, 2001); Grand Rapids, Michigan (61 FR 31831, 61 FR 31834-61 FR 31837, June 21, 1996); Cleveland-Akron-Lorain, Ohio (61 FR 20458, 61 FR 20469-61 FR 20470, May 7, 1996); Detroit, Michigan (60 FR 12459, 61 FR 12467-61 FR 12468, March 7, 1995). Missouri has demonstrated that the area will be able to maintain the standard without part D NSR in effect; therefore, EPA concludes that the state need not have a fully approved part D NSR program prior to approval of the redesignation request. Missouri's PSD program will become effective in the area upon redesignation to attainment.

Section 172(c)(6) requires the SIP to contain control measures necessary to provide for attainment of the NAAQS. Because attainment has been reached, no additional measures are needed to provide for attainment.

Section 172(c)(7) requires the SIP to meet the applicable provisions of section 110(a)(2). As noted above, we believe the Missouri SIP meets the requirements of section 110(a)(2) for purposes of redesignation.

Subpart 1 Section 176 Conformity Requirements. Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that Federally supported or funded projects conform to the air quality planning goals in the applicable SIP. The requirement to determine conformity applies to transportation plans, programs and projects that are developed, funded or approved under title 23 of the United States Code (U.S.C.) and the Federal Transit Act (transportation conformity) as well as to all other Federally supported or funded projects (general conformity). State transportation conformity SIP revisions must be consistent with Federal conformity regulations relating to consultation, enforcement and enforceability that EPA promulgated pursuant to its authority under the CAA.

EPA interprets the conformity SIP requirements as not applying for purposes of evaluating a redesignation request under section 107(d) because state conformity rules are still required after redesignation and Federal conformity rules apply where state conformity rules have not been approved.10 See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001) (upholding this interpretation); see also 60 FR 62748 (December 7, 1995) (redesignation of Tampa, Florida). Nevertheless, Missouri has an approved conformity SIP for the St. Louis-St. Charles-Farmington, MO-IL area. See 78 FR 53247 (August 29, 2013).

Section 182(a) Requirements. Section 182(a)(1) requires states to submit a comprehensive, accurate, and current inventory of actual emissions from sources of volatile organic compounds (VOCs) and nitrogen oxides (NOX) emitted within the boundaries of the ozone nonattainment area. The state's “Marginal Area Plan for the Missouri Portion of the St. Louis Nonattainment Area for the 2008 8-Hour Ground Level Ozone National Ambient Air Quality Standard” submitted by the state on September 9, 2014, included a 2011 base year emissions inventory for the Missouri portion of the St. Louis area. EPA approved this emissions inventory as a revision to the Missouri SIP on February 25, 2016 (81 FR 9346).

Under section 182(a)(2)(A), states with ozone nonattainment areas that were designated before the enactment of the 1990 CAA amendments were required to submit, within six months of classification, all rules and corrections to existing VOC reasonably available control technology (RACT) rules that were required under section 172(b)(3) before the 1990 CAA amendments. The St. Louis area is not subject to the section 182(a)(2) RACT “fix up” requirement for the 2008 ozone NAAQS because it was designated as nonattainment for this standard after the enactment of the 1990 CAA amendments and because Missouri complied with this requirement for the St. Louis area under the prior 1-hour ozone NAAQS.11

Section 182(a)(2)(B) requires each state with a marginal ozone nonattainment area that implemented or was required to implement a vehicle inspection and maintenance (I/M) program before the 1990 CAA amendments to submit a SIP revision for an I/M program no less stringent than that required prior to the 1990 CAA amendments or already in the SIP at the time of the CAA amendments, whichever is more stringent. For the purposes of the 2008 ozone standard and the consideration of Missouri's redesignation request for this standard, the St. Louis area is not subject to the section 182(a)(2)(B) requirement because the St. Louis area was designated as nonattainment for the 2008 ozone standard after the enactment of the 1990 CAA amendments.

Regarding the source permitting and offset requirements of section 182(a)(2)(C) and section 182(a)(4), as previously noted, Missouri currently has a fully-approved part D NSR program in place. The state's “Marginal Area Plan for the Missouri Portion of the St. Louis Nonattainment Area for the 2008 8-Hour Ground Level Ozone National Ambient Air Quality Standard” submitted in September 2014, included an offset ratio. As noted in the September 2014 SIP revision, the requirement for emission offset reductions is part of Missouri's NSR program and codified in the state's regulations at 10 CSR 10-6.060(7)(B)1. The corresponding offset ratio for each ozone area classification (i.e. 1.1:1 for Marginal) is found in the Federal code at 40 CFR 51.165(a)(3)(9). Thus Missouri has satisfied the CAA section 182(a)(4) requirement for Marginal Area Plan submissions in establishing a Marginal Area emission offset reduction ratio of 1.1:1 in its NSR program by SIP-approved rule consistent with the corresponding Federal code. EPA approved the September 2014 SIP revision on February 25, 2016 (81 FR 9346).

Section 182(a)(3) requires states to submit periodic emission inventories and a revision to the SIP to require the owners or operators of stationary sources to annually submit emission statements documenting actual VOC and NOX emissions. As discussed below, Missouri will continue to update its emissions inventory at least once every three years. With regard to stationary source emission statements, EPA last approved Missouri's emission statement rule on March 19, 2015 (80 FR 14312). In MDNR's May 22, 2015 submittal, Missouri stated that this approved SIP regulation remains in place and remains enforceable for the 2008 ozone standard. The state's “Marginal Area Plan for the Missouri Portion of the St. Louis Nonattainment Area for the 2008 8-Hour Ground Level Ozone National Ambient Air Quality Standard” SIP revision submitted in September 2014, noted that SIP approved state regulation 10 CSR 10-6.110 Reporting Emission Data, Emission Fees, and Process Information requires permitted sources to file an annual report on air pollutant emissions to include emissions data, process information, and annual emissions fees. EPA approved the September 2014 SIP revision on February 25, 2016 (81 FR 9346).

EPA is proposing to approve that the Missouri portion of the St. Louis area has satisfied all applicable requirements for purposes of redesignation under section 110 and part D of title I of the CAA.

As discussed above, EPA has fully approved the Missouri SIP for the St. Louis area under section 110(k) all requirements applicable for purposes of redesignation under the 2008 ozone NAAQS. EPA may rely on prior SIP approvals in approving a redesignation request (see the Calcagni memorandum at page 3; Southwestern Pennsylvania Growth Alliance v. Browner, 144 F.3d 984, 989-90 (6th Cir. 1998); Wall v. EPA, 265 F.3d 426), plus any additional measures it may approve in conjunction with a redesignation action (see 68 FR 25426 (May 12, 2003) and citations therein). Missouri has adopted and submitted, and EPA has fully approved at various times, provisions addressing the various SIP elements applicable for the ozone NAAQS.

As indicated above, EPA believes that the section 110 elements that are neither connected with nonattainment plan submissions nor linked to an area's nonattainment status are not applicable requirements for purposes of redesignation. EPA has approved all part D requirements applicable for purposes of this redesignation.

To support the redesignation of an area from nonattainment to attainment, section 107(d)(3)(E)(iii) of the CAA requires EPA to determine that the air quality improvement in the area is due to permanent and enforceable reductions in emissions resulting from the implementation of the SIP and applicable Federal air pollution control regulations and other permanent and enforceable emission reductions. EPA is proposing to determine that Missouri has demonstrated that the observed ozone air quality improvement in the St. Louis area is due to permanent and enforceable reductions in VOC and NOX emissions resulting from state measures adopted into the SIP and Federal measures.

In making this demonstration, the state has calculated the change in emissions between 2011 and 2014. The reduction in emissions and the corresponding improvement in air quality over this time period can be attributed to a number of regulatory control measures that the St. Louis area and upwind areas have implemented in recent years. Based on the information summarized below, Missouri has adequately demonstrated that the improvement in air quality is due to permanent and enforceable emissions reductions.

Clean Air Interstate Rule (CAIR)/Cross State Air Pollution Rule (CSAPR)/CSAPR Update. CAIR created regional cap-and-trade programs to reduce sulfur dioxide (SO2) and NOX emissions in twenty seven eastern states, including Missouri, that contributed to downwind nonattainment and maintenance of the 1997 8-hour ozone NAAQS and the 1997 fine particulate matter (PM2.5) NAAQS. See 70 FR 25162 (May 12, 2005). EPA approved Missouri's CAIR regulations into the Missouri SIP on December 14, 2007 (72 FR 71073). In 2008, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) initially vacated CAIR, North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008), but ultimately remanded the rule to EPA without vacatur to preserve the environmental benefits provided by CAIR, North Carolina v. EPA, 550 F.3d 1176, 1178 (D.C. Cir. 2008). On August 8, 2011 (76 FR 48208), acting on the D.C. Circuit's remand, EPA promulgated CSAPR to replace CAIR and thus to address the interstate transport of emissions contributing to nonattainment and interfering with maintenance of the two air quality standards covered by CAIR as well as the 2006 PM2.5 NAAQS. CSAPR requires substantial reductions of SO2 and NOX emissions from electric generating units (EGUs) in 28 states in the Eastern United States.

The D.C. Circuit's initial vacatur of CSAPR was reversed by the United States Supreme Court on April 29, 2014, and the case was remanded to the D.C. Circuit to resolve remaining issues in accordance with the high court's ruling. EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014).12 On remand, the D.C. Circuit affirmed CSAPR in most respects, but invalidated without vacating some of the CSAPR budgets as to a number of states. EME Homer City Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Cir. 2015). This litigation ultimately delayed implementation of CSAPR for three years, from January 1, 2012, when CSAPR's cap-and-trade programs were originally scheduled to replace the CAIR cap-and-trade programs, to January 1, 2015. Thus, the rule's Phase 2 budgets that were originally promulgated to begin on January 1, 2014, began on January 1, 2017.

On November 21, 2014, the Administrator signed an action that published in the Federal Register on December 3, 2014 (79 FR 71163), amending the regulatory text of CSAPR to reflect the Court's October 23, 2014, order tolling all deadlines in CSAPR by three years, including provisions governing the sunsetting of CAIR. CAIR therefore sunset at the end of 2014 and was replaced by CSAPR beginning January 1, 2015, which continue to remain in place. Relative to CAIR, CSAPR required similar or greater emission reductions from relevant upwind areas starting in 2015 and beyond, and Missouri's emissions budgets were not affected by the Court's remand of some of the ozone-season and SO2 budgets.

While the reduction in NOX emissions from the implementation of CSAPR will result in lower concentrations of transported ozone and ozone precursors entering the St. Louis area throughout the maintenance period, EPA is proposing to approve the redesignation of the St. Louis area without relying on those measures within Missouri as having led to attainment of the 2008 ozone NAAQS or contributing to maintenance of that standard because, as noted above, CSAPR did not go into effect until January 1, 2015. As a general matter, EPA expects that the implementation of CSAPR will preserve the reductions achieved by CAIR and result in additional SO2 and NOX emission reductions throughout the maintenance period.

In addition, on October 26, 2016 (81 FR 74504), EPA finalized the Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS (CSAPR Update). This new rule replaces the CSAPR rule for purposes of transport of ozone pollution with respect to the 2008 ozone NAAQS. The finalized rule issued a Federal Implementation Plan (FIP) that generally provided updated CSAPR NOX ozone season emission budgets for the EGUs within twenty two states in the eastern United States, and implements these budgets via modifications to the CSAPR NOX ozone season allowance trading program established under the original CSAPR. The CSAPR Update rule became effective on December 27, 2016.

Reductions in VOC and NOX emissions have occurred statewide and in upwind areas as a result of Federal emission control measures, with additional emission reductions expected to occur in the future. Federal emission control measures are described below.

Tier 2 Emission Standards for Vehicles and Gasoline Sulfur Standards. On February 10, 2000 (65 FR 6698), EPA promulgated Tier 2 motor vehicle emission standards and gasoline sulfur control requirements. These emission control requirements result in lower VOC and NOX emissions from new cars and light duty trucks, including sport utility vehicles. With respect to fuels, this rule required refiners and importers of gasoline to meet lower standards for sulfur in gasoline, which were phased in between 2004 and 2006. By 2006, refiners were required to meet a 30 ppm average sulfur level, with a maximum cap of 80 ppm. This reduction in fuel sulfur content ensures the effectiveness of low emission-control technologies. The Tier 2 tailpipe standards established in this rule were phased in for new vehicles between 2004 and 2009. EPA estimates that, when fully implemented, this rule will cut NOX and VOC emissions from light-duty vehicles and light-duty trucks by approximately 76 and 28 percent, respectively. NOX and VOC reductions from medium-duty passenger vehicles included as part of the Tier 2 vehicle program are estimated to be approximately 37,000 and 9,500 tons per year, respectively, when fully implemented. In addition, EPA estimates that beginning in 2007, a reduction of 30,000 tons per year of NOX will result from the benefits of sulfur control on heavy-duty gasoline vehicles. Some of these emission reductions occurred by the attainment years and additional emission reductions will occur throughout the maintenance period, as older vehicles are replaced with newer, compliant model years.

Heavy-Duty Diesel Engine Rules. In July 2000, EPA issued a rule for on-highway heavy-duty diesel engines that includes standards limiting the sulfur content of diesel fuel. Emissions standards for NOX, VOC and PM were phased in between model years 2007 and 2010. In addition, the rule reduced the highway diesel fuel sulfur content to 15 parts per million by 2007, leading to additional reductions in combustion NOX and VOC emissions. EPA has estimated future year emission reductions due to implementation of this rulemaking. Nationally, EPA estimated that 2015 NOX and VOC emissions would decrease by 1,260,000 tons and 54,000 tons, respectively. Nationally, EPA estimated that 2030 NOX and VOC emissions will decrease by 2,570,000 tons and 115,000 tons, respectively.

Nonroad Diesel Rule. On June 29, 2004 (69 FR 38958), EPA issued a rule adopting emissions standards for nonroad diesel engines and sulfur reductions in nonroad diesel fuel. This rule applies to diesel engines used primarily in construction, agricultural, and industrial applications. The rule is being phased between 2008 through 2015, and when fully implemented will reduce emissions of NOX, VOC, particulate matter, and carbon monoxide from these engines. It is estimated that compliance with this rule will cut NOX emissions from these nonroad diesel engines by approximately 90 percent nationwide.

Nonroad Spark-Ignition Engines and Recreational Engine Standards. On November 8, 2002 (67 FR 68242), EPA adopted emission standards for large spark-ignition engines such as those used in forklifts and airport ground-service equipment; recreational vehicles such as off-highway motorcycles, all-terrain vehicles, and snowmobiles; and recreational marine diesel engines. These emission standards are phased in from model year 2004 through 2012. When fully implemented, EPA estimates an overall 72 percent reduction in VOC emissions from these engines and an 80 percent reduction in NOX emissions. Some of these emission reductions occurred by the attainment years and additional emission reductions will occur throughout the maintenance period.

National Emission Standards for Hazardous Air Pollutants (NESHAP) for Reciprocating Internal Combustion Engines. On March 3, 2010 (75 FR 9684), EPA issued a rule to reduce hazardous air pollutants from existing diesel powered stationary reciprocating internal combustion engines, also known as compression ignition engines. Amendments to this rule were finalized on January 14, 2013 (78 FR 6674). EPA estimated that when this rule was fully implemented in 2013, NOX and VOC emissions from these engines would be reduced by approximately 9,600 and 36,000 tons per year, respectively.

Category 3 Marine Diesel Engine Standards. On April 30, 2010 (75 FR 22896), EPA issued emission standards for marine compression-ignition engines at or above 30 liters per cylinder. Tier 2 emission standards apply beginning in 2011, and are expected to result in a 15 to 25 percent reduction in NOX emissions from these engines. Final Tier 3 emission standards apply beginning in 2016 and are expected to result in approximately an 80 percent reduction in NOX from these engines. Some of these emission reductions occurred by the attainment years and additional emission reductions will occur throughout the maintenance period.

Gateway Vehicle Inspection Program. On March 3, 2015 (80 FR 11323), EPA approved Missouri's Gateway Vehicle Inspection Program which is found in the Missouri Code of State Regulation (CSR) at 10 CSR 5.381. This regulation is permanent and enforceable, and will result in continued significant reductions in both NOX and VOC emissions from 2014 to 2030.

Missouri is using a 2011 emissions inventory as the nonattainment base year. Area, nonroad mobile, onroad mobile, and point source emissions (EGUs and non-EGUs) were collected from the Ozone NAAQS Implementation Modeling platform (2011v6.1). MDNR also provided an emissions inventory for wildfires (Event) and biogenic sources. For 2011, this represents actual data Missouri reported to EPA for the 2011 National Emissions Inventory (NEI). Because emissions from state inventory databases, the NEI, and the Ozone NAAQS Emissions Modeling platform are annual totals, tons per summer day (tpd) were derived according to EPA's guidance document “Temporal Allocation of Annual Emissions Using EMCH Temporal Profiles” dated April 29, 2002, using the temporal allocation references accompanying the 2011v6.1 modeling inventory files.

For the attainment inventory, Missouri used 2014, one of the years the St. Louis area monitored attainment of the 2008 ozone standard. Because the 2014 NEI inventory was not available at the time MDNR was compiling the redesignation request, the state was unable to use the 2014 NEI inventory directly. For area, nonroad mobile, wildfire, and biogenic sources, 2014 emissions were derived by interpolating between 2011 and 2018 Ozone NAAQS Emissions Modeling platform inventories. The point source sector for the 2014 inventory was developed using actual 2014 point source emissions reported to the state database, which serve as the basis for the point source emissions reported to EPA for the NEI. Summer day inventories were derived for these sectors using the methodology described above. Finally, onroad mobile source emissions were developed using the same methodology described above for the 2011 inventory.

Using the inventories described above, Missouri's submittal documents changes in VOC and NOX emissions from 2011 to 2014 for the Missouri portion of the St. Louis area. Emissions data are shown in tables 2 through 6.

This proposal is authorized by section 311(j)(1)(C) of the CWA.

A list of entities that could be affected by requirements established under CWA section 311(j)(1)(C) is provided inTable 1:

The list of potentially affected entities in Table 1 may not be exhaustive. The Agency's aim is to provide a guide for readers regarding those entities that potentially could be affected by this action. However, this action may affect other entities not listed in this table. If you have questions regarding the applicability of this action to a particular entity, consult the person(s) listed in the preceding section entitled FOR FURTHER INFORMATION CONTACT.

The purpose of this proposal is to provide opportunity for public notice and comment on EPA's proposed approach to satisfy the requirements of CWA section 311(j)(1)(C) pertaining to CWA hazardous substances (HS).

CWA section 311(j)(1)(C) directs the President to issue regulations establishing procedures, methods, and equipment; and other requirements for equipment to prevent discharges of oil and HS from vessels and from onshore facilities and offshore facilities, and to contain such discharges.1 The President has delegated the authority to regulate non-transportation-related onshore facilities and offshore facilities landward of the coastline, under section 311(j)(1)(C) of the CWA to EPA.2

The term “hazardous substance” is defined in CWA section 311(a)(14). Section 311(b)(2)(A) authorizes regulations designating HS, which when discharged in any quantity into jurisdictional waters,3 present an imminent and substantial danger to public health or welfare, including, but not limited to, fish, shellfish, wildlife, shorelines, and beaches.

Once a chemical was designated as a CWA HS, as described in Section II.C, the corresponding quantity was established by regulation under the authority of CWA section 311(b)(4).4 The CWA prohibits discharges of CWA HS in quantities that may be harmful in section 311(b)(3).

In March 1978, EPA designated a list of CWA HS in 40 CFR part 116. EPA established reportable quantities for those substances in 40 CFR part 117 in August 1979 (see, for example, 43 FR 10474, March 13, 1978; 44 FR 50766, August 29, 1979). In September 1978, EPA proposed to establish requirements for Spill Prevention, Control, and Countermeasure (SPCC) Plans to prevent CWA HS discharges from facilities subject to permitting requirements under the National Pollution Discharge Elimination System (NPDES) program of the CWA (43 FR 39276, September 1, 1978). The Agency proposed to require owners and operators to develop CWA HS SPCC Plans that included, among other things, general requirements for appropriate containment, drainage control and/or diversionary structures; and specific requirements for the proper storage of liquids and raw materials, preventive maintenance and housekeeping, facility security, and training for employees and contractors. EPA did not finalize that proposed CWA HS SPCC rule. There is no information in the record to explain the reason the 1978 proposal was not finalized.

On July 21, 2015, the Environmental Justice Health Alliance for Chemical Policy Reform, People Concerned About Chemical Safety, and the Natural Resources Defense Council filed a lawsuit 5 against EPA for failing to comply with the alleged duty to issue regulations to prevent and contain CWA HS spills from non-transportation-related onshore facilities, including aboveground storage tanks, under CWA section 311(j)(1)(C).

On February 16, 2016, the United States District Court for the Southern District of New York entered a Consent Decree between EPA and the litigants establishing a schedule under which EPA is to sign “a notice of proposed rulemaking pertaining to the issuance of the Hazardous Substance Regulations” and take final action after notice and comment on said notice.6

EPA held three public meetings in 2016 to gain early input from stakeholders that EPA should consider during the rulemaking development. A public meeting was held in Charleston, West Virginia, on November 2; and two virtual public meetings were held on November 29 and December 1. EPA received input from a variety of stakeholders, including nongovernmental organizations, local governments, private citizens, and representatives from industry and trade organizations. Topics addressed in these discussions included:

• Establish spill prevention and right-to-know requirements for chemicals.

• Require secondary containment and inspections of primary and secondary containment to assure continued compliance.

• Require information about downstream public water intakes to allow prompt notification after a spill.

• Concerns about CBI should not prohibit notifying residents about the risks of the chemicals stored or released.

• EPA must enforce standards for them to be effective.

• A number of Federal and state regulations already require spill prevention measures and EPA should not establish redundant or conflicting requirements.

The public input received is available in the docket.7

We intend to supplement the information that this action is based on with an additional information collection. This information collection would be a voluntary survey of U.S. states, tribes, and territories that would request information on the number and type of facilities with CWA HS onsite; historical discharges of CWA HS; the ecological and human health impacts of those discharges; and existing state, territory, and Tribal programs that address discharge prevention of CWA HS. EPA anticipates using the results of the survey to further inform this regulatory action.8

EPA is proposing no new regulatory requirements under the authority of CWA section 311(j)(1)(C) at this time. This determination is based on an analysis of identified CWA HS discharges, and an evaluation of the existing framework of EPA regulatory requirements relevant to preventing and containing CWA HS discharges.

The Agency set forth to determine what regulatory requirements under CWA section 311(j)(1)(C) would be appropriate to prevent CWA HS discharges. To this end, EPA analyzed the frequency of and reported impacts of the identified CWA HS discharges.

Next, EPA identified an analytical framework of discharge prevention, containment, and mitigation provisions, or program elements, commonly found in discharge and accident prevention regulatory programs. EPA then conducted a review of existing EPA regulatory programs to determine which regulations, such as NPDES, Resource Conservation and Recovery Act (RCRA), Risk Management Program (RMP), and others include these program elements and also apply to CWA HS.

Based on the reported frequency and impacts of identified CWA HS discharges, and the Agency's evaluation of the existing framework of EPA regulatory requirements relevant to preventing CWA HS discharges, EPA has determined that the existing framework of regulatory requirements serves to prevent CWA HS discharges. Additionally, EPA identified relevant requirements in other Federal regulatory programs and determined that they further serve to prevent CWA HS discharges, providing additional support for this proposed action.

EPA analyzed CWA HS discharges reported to the National Response Center (NRC) 9 over a 10-year period to estimate the frequency of CWA HS discharges and to understand the reported impacts of these discharges to communities that were potentially affected.10 40 CFR 117.21 requires immediate notification to the NRC once the person in charge of a vessel or an offshore or onshore facility has knowledge of a discharge of a designated CWA HS from the facility in quantities equal to or exceeding, in any 24-hour period, the reportable quantity.

During 2007-2016, the NRC received reports of 285,867 releases of all kinds (including for example of oil, chemical, radiological, biological to a variety of media). EPA then further analyzed the data to identify discharges of CWA HS that impacted water from facilities in EPA's regulatory jurisdiction. Based on the NRC database review 11 and recognizing the data limitations discussed further in Section III.A.3, EPA identified 9,416 reports of CWA HS discharges out of the total received (3.3 percent) for this time period. Of these CWA HS discharge reports, the Agency further refined the analysis by identifying 3,140 reports that were reported to have reached water (see discussion below on NRC data limitations). Within that universe, 2,491 (less than one percent of the reports) were identified as CWA HS discharges reported to have originated from non-transportation-related sources.

EPA further analyzed the NRC data to examine how many of the CWA HS discharges to water from non-transportation-related facilities had reported impacts. This information was supplemented with reported impact data for identified CWA HS discharges from the National Toxic Substance Incidents Program (NTSIP).12 Impacts reported to NRC and NTSIP include evacuations, injuries, hospitalizations, fatalities, waterway closures, and water supply contamination. A total of 117 CWA HS discharge reports (4.7 percent) included one or more of these impacts out of the 2,491 identified CWA HS discharges to water, reported as originating from non-transportation-related sources over the 10-year period analyzed.

EPA seeks comment on the approach used to analyze the frequency of CWA HS discharges and to quantify the impacts of CWA HS discharges. Specifically, EPA requests additional data sources, information, and approaches that may allow EPA to further revise or refine the estimated impacts of CWA HS discharges from non-transportation-related sources, nationally.

In addition to determining the frequency of CWA HS discharges, EPA also analyzed the reporting data to identify the CWA HS most frequently discharged. Of 292 CWA HS currently designated in 40 CFR part 116, the following 13 CWA HS comprised the majority of identified discharges, as well as the majority of identified discharges with reported impacts (Table 2).

A. Why are revisions to State programs necessary?

States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the federal program. As the federal program changes, states must change their programs and ask EPA to authorize the changes. Changes to state programs may be necessary when federal or state statutory or regulatory authority is modified or when certain other changes occur. Most commonly, states must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.

On December 13, 2017, Hawaii submitted a final complete program revision application seeking authorization of changes to its hazardous waste program corresponding to certain federal rules promulgated between May 26, 1998 and June 30, 2016 (also known as RCRA Checklist 167 and Clusters IX through XXIV) plus several changes initiated by the State. EPA concludes that Hawaii's application to revise its authorized program meets all statutory and regulatory requirements established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, EPA proposes to grant Hawaii final authorization to operate as part of its hazardous waste program the changes listed below in Section F of this document, as further described in the authorization application.

Hawaii has responsibility for permitting treatment, storage, and disposal facilities within its borders and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA).

The effect of this decision is that the changes described in Hawaii's authorization application will become part of the authorized state hazardous waste program, and therefore will be federally enforceable. Hawaii will continue to have primary enforcement authority and responsibility for its state hazardous waste program. EPA retains its authorities under RCRA sections 3007, 3008, 3013, and 7003, including its authority to:

• Conduct inspections, and require monitoring, tests, analyses or reports;

• Enforce RCRA requirements, including authorized state program requirements, and suspend or revoke permits; and

• Take enforcement actions regardless of whether the state has taken its own actions.

This action does not impose additional requirements on the regulated community because the regulations for which Hawaii is being authorized by today's action are already effective, and are not changed by today's action.

EPA will consider all comments received during the comment period and address all such comments in a final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so during the comment period for this proposed rule.

Hawaii initially received final authorization to implement its base hazardous waste management program including federal program revisions through May 25, 1998 (Cluster VIII partial) on November 13, 2001 (66 FR 55115). Since initial authorization Hawaii has not applied for or received authorization for revisions to its hazardous waste program.

Hawaii has applied to EPA for authorization of changes to its hazardous waste program that correspond to certain federal rules promulgated between May 25, 1998 and July 1, 2016 (also known RCRA Cluster VIII through XXIV) and for authorization of state-initiated changes that are equivalent to or more stringent than the federal program.

EPA proposes to determine, subject to public review and comment, that Hawaii's hazardous waste program revisions as described in the State's authorization revision application dated November 22, 2017 are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all the requirements necessary to qualify for final authorization. Regulatory revisions that are less stringent than the Federal program requirements and those regulatory revisions that are broader in scope than the Federal program requirements are not authorized. Accordingly, EPA proposes to grant Hawaii final authorization for the program changes described below.

Hawaii has revised the format of its hazardous waste regulations from verbatim adoption to incorporation by reference of the Federal hazardous waste management regulations into their counterpart Hawaii Administrative Rules (HAR). HAR chapter 11-280 has been repealed without replacement. The requirements for public availability of information (RCRA § 3006(f)) previously found in 11-280 are met by HAR chapters 2-71 and 11-1, HRS chapter 92F and sections 342J-14 and 342J-14.5, and provisions adopted from Federal rules (40 CFR 260.2) in HAR chapter 11-260.1.

The repeal of the verbatim adoption of the Federal program in HAR Title 11 chapters 260, 261, 262, 263, 264, 265, 266, 268, 270, 271, 273, 279, and 280 is replaced by incorporation by reference (“IBR”) into HAR Title 11 chapters 260.1, 261.1, 262.1, 263.1, 264.1, 265.1, 266.1, 268.1, 270.1, 271.1, 273.1, and 279.1 and are effective July 17, 2017. The applicable Federal rules and analogous State rules are identified in the table below.

Under RCRA § 3009, the EPA may not authorize state rules that are less stringent than the Federal program. Any state rules that are less stringent do not supplant the federal regulations. State rules that are broader in scope than the Federal program requirements are allowed but do not become part of the enforceable federal program. State rules that are equivalent to or more stringent than the federal program may be authorized, in which case they are enforceable by the EPA.

This section does not discuss the program differences previously published in Hawaii's base program authorization in 2001, at 66 FR 55115 (November 1, 2001). Areas identified in the base program authorization as more stringent or broader in scope than the federal program have been carried forward into the new regulations as amendments or additions to the incorporation by reference of the federal regulations. This section discusses new State requirements that are more stringent, or new requirements that are broader in scope and cannot be authorized.

States may seek authorization for state requirements that are more stringent than federal requirements. The EPA has the authority to authorize and enforce those parts of a state's program the EPA finds to be more stringent than the federal program. This section does not discuss each more stringent finding made by the EPA, but rather rules of particular interest that were not previously described in 2001, available at 66 FR 55115, November 1, 2001. Persons should consult the docket for this rule, including Hawaii's revised Program Description, dated May 1, 2018 for a complete list of rules determined to be more stringent than federal rules.

i. More stringent regulation of specific wastes

a. Solvent-Contaminated Wipes: Hawaii is adopting the conditional exclusions for solvent-contaminated wipes addressed by Revision Checklist 229, but is adding one additional condition to the incorporated version of 40 CFR 261.4(a)(26) and 261.4(b)(18): Containers in which solvent-contaminated wipes eligible for the exclusion are being accumulated must be labeled with the accumulation start date.

b. Spent lead-acid batteries: Hawaii regulates persons who generate, transport, collect, or store spent-lead acid batteries sent for reclamation (other than through regeneration) as handlers/transporters of universal waste under chapter 11-273.1. This is more stringent than the federal program, which exempts these groups from many regulations under 40 CFR 266.80.

ii. Notification before cancellation of certain financial assurance instruments. Hawaii requires hazardous waste treatment, storage, and disposal facilities, and reclamation and intermediate facilities managing hazardous secondary materials, to notify both the State Director and the Regional Administrator before cancellation of certain financial assurance instruments. The federal regulations require only one authority to be notified, so the requirement to notify the Regional Administrator in addition to the State Director is more stringent than the federal regulation. This applies to surety bonds, letters of credit, corporate guarantees, liability endorsements, certificates of liability insurance, and standby letters of credit (Incorporated version of 40 CFR 261.151(b), (c), (g), (h), (i), (j), (k), 264.151(b), (c), (d), (h), (i), (j), (k), and (l)).

iii. Used oil processor facility standards: The State does not allow for exceptions to the requirement that used oil processors have emergency equipment listed in 40 CFR 279.52(a)(2). The State also does not allow for the possibility that aisle space required in 279.52(a)(5) is not necessary.

iv. Notification in case of emergency. Hawaii requires notification of emergencies to the State Hazard Evaluation and Emergency Response (HEER) office designated on-scene coordinator in addition to the National Response Center (NRC) for: Facilities handling secondary hazardous materials (HSM), generators of hazardous waste, transporters of hazardous waste and used oil, treatment, storage, and disposal facilities and used oil processors.

v. Recordkeeping requirements. The State requires the following additional recordkeeping requirements:

a. Generator container storage area inspection log: Generators must keep a log of the weekly container storage area inspections.

b. Universal waste transporters: Universal waste transporters must maintain the same type of records that Large Quantity Handlers of Universal Waste and Destination Facilities must maintain. Records must be maintained for three years.

c. Used oil generators: Used oil generators must keep records of shipments, similar to the records required for used oil transporters under the federal program. These records must be maintained for three years.

d. Used oil processors: Used oil processors must keep records of the equipment testing and maintenance required by 40 CFR 279.52(a)(3) (in the incorporated version of 279.57(a)(2)).

vi. Permits: The State limits the duration of Remedial Action Plans to five years instead of ten (40 CFR 270.195).

vii. No standard permit option: The State has not adopted federal regulations allowing standardized permits.

viii. Used oil management.

a. Used oil testing: The State requires that used oil transporters and processors make a hazardous waste determination for used oil sent for disposal. The State regulations allow used oil burners and marketers to either test used oil for halogens or obtain results of tests performed by the processor.

b. Annual reporting for used oil processors: The State requires used oil processors to submit an annual report of used oil activities by July 31. The content of the report is similar to the biennial report required in the federal program and replaces the used oil biennial reporting requirement (40 CFR 279.57(b)).

ix. Alternative groundwater monitoring plans. The State has added a requirement that any interim status facility opting for an alternative groundwater monitoring plan under the incorporated version of 40 CFR 265.90(d) submit a copy of the plan to the department, in addition to maintaining the plan on-site at the facility.

x. Notification of newly regulated hazardous waste activity. State regulations (HRS 342J-6.5) require generators, transporters, and owners or operators of treatment, storage, or disposal facilities newly regulated due to a change in the definition of hazardous waste (HAR chapter 11-261.1) to submit a notification within 45 days of the regulatory revision (rather than the federal requirement of 90 days) (40 CFR 270.1(b)).

xi. Academic laboratory generator standards: The State is not adopting the alternative requirements for hazardous waste determination and accumulation of unwanted materials at academic laboratories, (73 FR 72912, December 1, 2008 and 75 FR 79304, December 20, 2010).

xii. Used oil storage requirements: The State has added language to the incorporated version of 40 CFR 279.22, 279.45, 279.54, 279.64, to clarify that containers and aboveground tanks storing used oil must be kept closed.

i. Coal combustion residuals: The State is not adopting the Federal final rule that added a list of coal combustion residuals to 40 CFR 261.4(b)(4)(ii) to the ash and other waste types from coal combustion that were already included in an exemption from the definition of hazardous waste, if these residuals are co-disposed with the waste types originally listed (80 FR 21302-21501, October 19, 2015). Hawaii does not exclude these waste types from the definition of solid waste.

ii. Cathode Ray Tubes and Carbon Dioxide Streams in Geological Sequestration Activities: Hawaii is not adopting the Federal final rules that introduced and/or revised conditional exclusions for (1) Cathode Ray Tubes (CRTs) from the definition of solid waste (40 CFR 261.4(a)(22)) and (2) carbon dioxide (CO2) streams in geological sequestration activities from the definition of hazardous waste (at 40 CFR 261.4(h)). Hawaii program is broader in scope so long as all the conditions of the Federal exclusion are met.

The State has added a category of universal waste to HAR chapter 11-273.1 called “electronic items” and defined waste management and labeling/marking requirements for this type of universal waste. The State determined, based on extensive research, that most waste electronic items are toxicity characteristic hazardous wastes due to the presence and concentration of one or more metals (e.g. lead, cadmium) and may also contain other dangerous constituents, such as a brominated (flame retardant) plastics. The State also determined that electronic items (as defined in HAR chapters 11-260.1 and 11-273.1) as a category meet the criteria of 40 CFR 273.81. EPA allows authorized States to create regulations for State-only universal wastes provided that these criteria are met for the waste or waste category, including the key requirements that universal waste management is sufficiently protective of human health and the environment and that regulation as universal waste increases the likelihood of similar unregulated wastes (such as CESQG or household wastes) being diverted from non-hazardous to hazardous waste management systems.

i. Contested case hearings and declaratory orders: The State's previous regulations governing contested case hearings (HAR chapter 11-271 subchapter B, based on 40 CFR part 22) and declaratory rulings (HAR chapter 11-271 subchapter C) for the hazardous waste program have been repealed. The State Department of Health has similar department-wide procedures for case hearings and declaratory orders that now apply (HAR chapter 11-1). The State is not adopting an equivalent to 40 CFR 124.19 and instead adds procedures for requesting a contested case hearing in the incorporated version of 40 CFR 124.15 in HAR chapter 11-271.1.

ii. Public availability of information: The State's previous regulations regarding public availability of information and treatment of confidential business information (HAR chapter 11-280) have been repealed. Requests for public information will be handled under HRS 342J-14 and 342J-14.5 and applicable provisions of HRS chapter 92F and HAR chapter 2-71, which are referenced in the incorporated version of 40 CFR 260.2. EPA determines that Hawaii's requirements for public availability of information and treatment of confidential business information are substantially similar to EPA's federal regulations.

Other than the differences discussed above, Hawaii incorporates by reference the remaining federal rules listed in Section F; therefore, there are no significant differences between the remaining federal rules and the revised state rules being authorized today.

Hawaii will continue to issue permits for all the provisions for which it is authorized and will administer the permits it issues. Section 3006(g)(1) of RCRA, 42 U.S.C. 6926(g)(1), gives EPA the authority to issue or deny permits or parts of permits for requirements for which the State is not authorized. Therefore, whenever EPA adopts standards under HSWA for activities or wastes not currently covered by the authorized program, EPA may process RCRA permits in Hawaii for the new or revised HSWA standards until Hawaii has received final authorization for such new or revised HSWA standards.

Codification is the process of placing the state's statutes and regulations that comprise the state's authorized hazardous waste program into the Code of Federal Regulations. EPA does this by referencing the authorized state rules in 40 CFR part 272. EPA is not codifying the authorization of Hawaii's changes at this time. However, EPA reserves the amendment of 40 CFR part 272, subpart M for this authorization of Hawaii's program changes until a later date.

The Office of Management and Budget (OMB) has exempted this action (RCRA State authorization) from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). This action authorizes state requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by state law. Therefore, this action is not subject to review by OMB. This action is not an Executive Order 13771 (82 FR 9339, February 3, 2017) regulatory action because actions such as this proposed authorization of Hawaii's revised hazardous waste program under RCRA are exempted under Executive Order 12866. This action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action authorizes pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes state requirements as part of the state RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

Under RCRA 3006(b), the EPA grants a State's application for authorization, as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a state authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. Because this rule authorizes pre-existing state rules which are at least equivalent to, and no less stringent than existing federal requirements, and impose no additional requirements beyond those imposed by state law, and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action nevertheless will be effective 60 days after the final approval is published in the Federal Register.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

The Department of Health and Human Services (HHS) is working to transform the healthcare system into one that pays for value. Care coordination is a key aspect of systems that deliver value. Removing unnecessary government obstacles to care coordination is a key priority for HHS. To help accelerate the transformation to a value-based system that includes care coordination, HHS has launched a Regulatory Sprint to Coordinated Care, led by the Deputy Secretary. This Regulatory Sprint is focused on identifying regulatory requirements or prohibitions that may act as barriers to coordinated care, assessing whether those regulatory provisions are unnecessary obstacles to coordinated care, and issuing guidance or revising regulations to address such obstacles and, as appropriate, encouraging and incentivizing coordinated care.

The Centers for Medicare & Medicaid Services (CMS) has made facilitating coordinated care a top priority and seeks to identify ways in which its regulations may impose undue burdens on the healthcare industry and serve as obstacles to coordinated care and its efforts to deliver better value and care for patients. Through internal discussion and input from external stakeholders, CMS has identified some aspects of the physician self-referral law as a potential barrier to coordinated care. Addressing unnecessary obstacles to coordinated care, real or perceived, caused by the physician self-referral law is one of CMS's goals in this Regulatory Sprint. To inform our efforts to assess and address the impact and burden of the physician self-referral law, including whether and, if so, how it may prevent or inhibit care coordination, we welcome public comment on the physician self-referral law and, in particular, comment on the questions presented in this Request for Information (RFI).

When enacted in 1989, the physician self-referral law (section 1877 of the Social Security Act), also known as the “Stark Law,” addressed the concern that health care decision making can be unduly influenced by a profit motive. When physicians have a financial incentive to refer patients for health care services, this incentive may affect utilization, patient choice, and competition. Overutilization may occur when items and services are ordered that would not have been ordered absent a profit motive. A patient's choice can be affected when he or she is steered to less convenient, lower quality, or more expensive providers of health care that are sharing profits with, or providing other remuneration to, the referring practitioner. Where referrals are controlled by those sharing profits or receiving other remuneration, the medical marketplace suffers since new competitors may have more difficulty generating business on superior quality, service, or price alone.

By design, the physician self-referral law is intended to disconnect a physician's health care decision making from his or her financial interests in other health care providers and suppliers. Specifically, the law: (1) Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless an exception applies; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. The prohibitions are absolute unless the physician's referral is permitted under an enumerated exception. The statute establishes a number of specific exceptions, and grants the Secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse. For more information, please refer to the CMS physician self-referral website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/index.html?redirect=/PhysicianSelfReferral/.

CMS is aware of the effect the physician self-referral law may have on parties participating or considering participation in integrated delivery models, alternative payment models, and arrangements to incent improvements in outcomes and reductions in cost. The President's Budget for fiscal year (FY) 2019 included a legislative proposal to establish a new exception to the physician self-referral law for arrangements that arise due to participation in alternative payment models. In addition to this legislative proposal, CMS has engaged stakeholders through comment solicitations in several recent rulemakings. In 2017, through the annual payment rules, CMS asked for comments on improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, other providers, and patients and their families. In response, commenters shared additional information regarding the barriers to participation in health care delivery and payment reform efforts, both public and private, as well as the burdens of compliance with the physician self-referral law and our regulations as they exist today. As a result of our review of these comments, and with a goal of reducing regulatory burden and dismantling barriers to value-based care transformation, while also protecting the integrity of the Medicare program, we are requesting additional information in this RFI. We are particularly interested in your thoughts on issues that include, but are not limited to, the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the physician self-referral law, and terminology related to alternative payment models and the physician self-referral law. We look forward to receiving your input on this RFI.

We are requesting public input on the following areas:

1. Please tell us about either existing or potential arrangements that involve DHS entities and referring physicians that participate in alternative payment models or other novel financial arrangements, whether or not such models and financial arrangements are sponsored by CMS. Please include a description of the alternative payment model(s) and novel financial arrangements if not sponsored by CMS. We recommend that you identify concerns regarding the applicability of existing exceptions to the physician self-referral law and/or the ability of the arrangements to satisfy the requirements of an existing exception, as well as the extent to which the physician self-referral law may be impacting commercial alternative payment models and novel financial arrangements. Please be specific regarding the terms of the arrangements with respect to the following:

• The categories/types of parties (for example, the parties are a hospital and physician group with downstream payments to individual physicians in the group).

• Which parties bear risk (and how and to what extent) under the arrangement (for example, per capita payments from a payor are paid to a hospital with downstream payments on a discounted fee schedule to individual physicians; a bundled payment from a payor for all hospital and physician services is split between a hospital and physicians based on a predetermined percentage; hospital-sponsored gainsharing program where participating physicians share in cost savings; physician incentive payments are available for achieving predetermined metrics; etc.).

• The scope of the arrangement (for example, non-Medicare beneficiaries only, Medicare beneficiaries only, or all patients regardless of payor).

• The timeframe of the arrangement (for example, ongoing or for a duration that aligns with a payor-specific initiative).

• Items and services provided under the arrangement and by whom (for example, infrastructure, such as electronic health records technology; physician services; care coordination services; etc.).

• How the arrangement furthers the purpose of the alternative payment model or novel financial arrangement.

• Whether and, if so, how the arrangement mitigates the financial incentives for inappropriate self-referrals, and/or overutilization of items and services, and patient choice.

2. What, if any, additional exceptions to the physician self-referral law are necessary to protect financial arrangements between DHS entities and referring physicians who participate in the same alternative payment model? Specifically—

• What additional exceptions are necessary to protect accountable care organization models?

• What additional exceptions are necessary to protect bundled payment models?

• What additional exceptions are necessary to protect two-sided risk models in a FFS environment?

• What additional exceptions are necessary to protect other payment models (please explain the nature and design of such models)?

• How (if at all) should a new exception (or exceptions) protect individual DHS referrals (see 42 CFR 411.355), ownership or investment interests (see 42 CFR 411.356), or compensation arrangements (see 42 CFR 411.357)?

3. What, if any, additional exceptions to the physician self-referral law are necessary to protect financial arrangements that involve integrating and coordinating care outside of an alternative payment model? Specifically, what types of financial arrangements and/or remuneration related to care integration and coordination should be protected and why? How (if at all) should a new exception (or exceptions) protect individual DHS referrals (see 42 CFR 411.355), ownership or investment interests (see 42 CFR 411.356), or compensation arrangements (see 42 CFR 411.357)?

4. Please share your thoughts on the utility of the current exception at 42 CFR 411.357(n) for risk-sharing arrangements.

5. Please share your thoughts on the utility of the special rule for compensation under a physician incentive plan within the exception at 42 CFR 411.357(d) for personal service arrangements.

6. Please share your thoughts on possible approaches to address the application of the physician self-referral law to financial arrangements among participants in alternative payment models and other novel financial arrangements. Consider the following:

• Would a single exception provide sufficient protection for all types of financial arrangements?

• Would a multifaceted approach that amends existing exceptions and/or establishes new exceptions be preferable?

• Would such a multifaceted approach sufficiently allow parties to identify and satisfy the requirements of one (or more) applicable exceptions in order to protect individual DHS referrals, ownership or investment interests, and/or compensation arrangements?

7. In the context of health care delivery, payment reform, and the physician self-referral law, please share your thoughts on definitions for critical terminology such as—

8. Please identify and suggest definitions for other terminology relevant to the comments requested in this RFI.

9. Please share your thoughts on possible approaches to defining “commercial reasonableness” in the context of the exceptions to the physician self-referral law.

10. Please share your thoughts on possible approaches to modifying the definition of “fair market value” consistent with the statute and in the context of the exceptions to the physician self-referral law.

11. Please share your thoughts on when, in the context of the physician self-referral law, compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement. Please share with us, by way of example or otherwise, compensation formulas that do not take into account the volume or value of referrals by a physician or other business generated between parties.

12. Please share your thoughts on when, in the context of alternative payment models and other novel financial arrangements, compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement. Please share with us, by way of example or otherwise, compensation formulas that do not take into account the volume or value of referrals by a physician or other business generated between parties.

13. Please share your thoughts regarding whether and, if so, what barriers exist to qualifying as a “group practice” under the regulations at 42 CFR 411.352.

14. Please share your thoughts on the application and utility of the current exception at 42 CFR 411.357(g) for remuneration unrelated to DHS. Specifically, how could CMS interpret this exception to cover a broader array of arrangements?

15. Please identify any provisions, definitions, and/or exceptions in the regulations at 42 CFR 411.351 through 411.357 for which additional clarification would be useful.

16. Please share your thoughts on the role of transparency in the context of the physician self-referral law. For example, if provided by the referring physician to a beneficiary, would transparency about physician's financial relationships, price transparency, or the availability of other data necessary for informed consumer purchasing (such as data about quality of services provided) reduce or eliminate the harms to the Medicare program and its beneficiaries that the physician self-referral law is intended to address?

17. Please share your thoughts on whether and how CMS could design a model to test whether transparency safeguards other than those currently contained in the physician self-referral law could effectively address the impact of financial self-interest on physician medical decision-making.

18. Please share your thoughts on the compliance costs for regulated entities.

19. Please identify any recent studies assessing the positive or negative effects of the physician self-referral law on the healthcare industry. To the extent publicly available, please provide a copy of the study(ies).

20. Please share your thoughts regarding whether CMS should measure the effectiveness of the physician self-referral law in preventing unnecessary utilization and other forms of program abuse relative to the cost burden on the regulated industry and, if so, how CMS could estimate this.

Respondents are encouraged to provide complete but concise and organized responses, including any relevant data and specific examples. However, respondents are not required to address every issue or respond to every question discussed in this RFI to have their responses considered. In accordance with the implementing regulations of the Paperwork Reduction Act at 5 CFR 1320.3(h)(4), all responses will be considered provided they contain information CMS can use to identify and contact the commenter, if needed.

Please note, this is a request for information only. As previously stated, respondents are encouraged to provide complete but concise responses. This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), application, proposal abstract, or quotation. This RFI does not commit the U.S. Government to contract for any supplies or services or make a grant award. Further, CMS is not seeking proposals through this RFI and will not accept unsolicited proposals. Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Not responding to this RFI does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor this RFI announcement for additional information pertaining to this request. Please note that CMS will not respond to questions about the policy issues raised in this RFI. CMS may or may not choose to contact individual responders. Such communications would only serve to further clarify written responses. Contractor support personnel may be used to review RFI responses.

Responses to this RFI are not offers and cannot be accepted by the U.S. Government to form a binding contract or issue a grant. Information obtained as a result of this RFI may be used by the U.S. Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. This RFI should not be construed as a commitment or authorization to incur costs for which reimbursement would be required or sought. All submissions become U.S. Government property and will not be returned. CMS may publicly post the comments received, or a summary thereof.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. However, section III. of this document does contain a general solicitation of comments in the form of a request for information. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency's full consideration, are not generally considered information collections and therefore not subject to the PRA. 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.).

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, if we proceed with a subsequent document, we may respond to the comments in the preamble to that document.