Federal Register Vol. 81, No.164,

OPM is issuing a proposed rule that would define Kent County, MI, as an area of application county to the Macomb, MI, NAF FWS wage area and Cameron County, TX, as an area of application county to the Nueces, TX, NAF FWS wage area. The Veterans Canteen Service (VCS) now employs one NAF FWS employee at VCS #315 in the Wyoming Health Care Center in Kent County and two NAF FWS employees at VCS #740 in the Veterans Affairs Health Care Center at Harlingen in Cameron County.

Under § 532.219 of title 5, Code of Federal Regulations, each NAF wage area “shall consist of one or more survey areas, along with nonsurvey areas, if any, having nonappropriated fund employees.” Kent and Cameron Counties do not meet the regulatory criteria under 5 CFR 532.219 to be established as separate NAF wage areas; however, nonsurvey counties may be combined with a survey area to form a wage area. Section 532.219 lists the regulatory criteria that OPM considers when defining FWS wage area boundaries.

OPM recently completed reviews of the definitions of Kent and Cameron Counties and is proposing the changes described below. The Federal Prevailing Rate Advisory Committee, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, recommended these changes by consensus. These changes would apply on the first day of the first applicable pay period beginning on or after 30 days following publication of the final regulations.

Kent County would be defined as an area of application county to the Macomb, MI, NAF FWS wage area. The closest NAF wage area to Kent County is the Macomb wage area. There are no other NAF wage areas in the immediate vicinity of Kent County. VCS #315 is located approximately 175 miles from Selfridge Air National Guard Base, the Macomb wage area's host activity.

With the definition of Kent County to the Macomb NAF wage area, the Macomb wage area would consist of 1 survey county, Macomb County, MI, and 13 area of application counties: Alpena, Calhoun, Crawford, Grand Traverse, Huron, Iosco, Kent, Leelanau, Ottawa, Saginaw, Washtenaw, and Wayne Counties, MI; and Ottawa County, OH.

Cameron County would be defined as an area of application county to the Nueces, TX, NAF FWS wage area. The closest NAF wage area to Cameron County is the Nueces wage area. There are no other NAF wage areas in the immediate vicinity of Cameron County. VCS #740 is located approximately 148 miles from Naval Air Station Corpus Christi, the Nueces wage area's host activity.

With the definition of Cameron County to the Nueces NAF wage area, the Nueces wage area would consist of one survey county, Nueces County, TX, and six area of application counties: Bee, Calhoun, Cameron, Kleberg, San Patricio, and Webb Counties, TX.

I certify that these regulations would not have a significant economic impact on a substantial number of small entities because they would affect only Federal agencies and employees.

Accordingly, OPM is proposing to amend 5 CFR part 532 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 September 28, 2015, Finnoff Aviation applied for a supplemental type certificate for installation of a rechargeable lithium battery in the Model PC-12, PC-12/45, PC-12/47 airplanes. The Model PC-12, PC-12/45, PC-12/47 airplanes are single-engine turboprop-powered business aircraft that can accommodate up to nine passengers with a take-off weight up to 10,450 lbs.

The current regulatory requirements for part 23 airplanes do not contain adequate requirements for the application of rechargeable lithium batteries in airborne applications. This type of battery possesses certain failure and operational characteristics with maintenance requirements that differ significantly from that of the nickel-cadmium (Ni-Cd) and lead-acid rechargeable batteries currently approved in other normal, utility, acrobatic, and commuter category airplanes. Therefore, the FAA is proposing this special condition to address (1) all characteristics of the rechargeable lithium batteries and their installation that could affect safe operation of the modified Model PC-12, PC-12/45, and PC-12/47 airplanes, and (2) appropriate Instructions for Continued Airworthiness (ICAW) that include maintenance requirements to ensure the availability of electrical power from the batteries when needed.

Under the provisions of § 21.101, Finnoff Aviation must show that the Model PC-12, PC-12/45, and PC-12/47, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A78EU 1 or the applicable regulations in effect on the date of application for the change.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 23) do not contain adequate or appropriate safety standards for the Model PC-12, PC-12/45, and PC-12/47 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Model PC-12, PC-12/45, and PC-12/47 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

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

The Model PC-12, PC-12/45, and PC-12/47 airplanes will incorporate the following novel or unusual design feature: Installation of a rechargeable lithium battery as the main or engine start aircraft battery.

Presently, there is limited experience with use of rechargeable lithium batteries and rechargeable lithium battery systems in applications involving commercial aviation. However, other users of this technology, ranging from personal computers, wireless telephone manufacturers to the electric vehicle industry, have noted safety problems with lithium batteries. These problems include overcharging, over-discharging, flammability of cell components, and cell internal defects described in the following paragraphs:

1. Overcharging: In general, lithium batteries are significantly more susceptible to internal failures that can result in self-sustaining increases in temperature and pressure (i.e., thermal runaway) than the Ni-Cd or lead-acid counterparts. This is especially true for overcharging which causes heating and destabilization of the components of the cell, leading to the formation (by plating) of highly unstable metallic lithium. The metallic lithium may ignite, resulting in a fire or explosion. Finally, the severity of thermal runaway due to overcharging increases with increasing battery capacity and due to a higher amount of electrolyte in large batteries.

2. Over-discharging: Discharge of some types of lithium battery cells beyond a certain voltage (typically 2.4 volts) can cause corrosion of the electrodes of the cell, resulting in loss of battery capacity that cannot be reversed by recharging. This loss of capacity may not be detected by the simple voltage measurements commonly available to flight crews as a means of checking battery status, which is a problem shared with Ni-Cd batteries.

3. Flammability of Cell Components: Unlike Ni-Cd and lead-acid batteries, some types of lithium batteries use liquid electrolytes that are flammable. The electrolyte may serve as a source of fuel for an external fire, if there is a breach of the battery container.

4. Cell Internal Defects: The rechargeable lithium batteries and rechargeable battery systems have a history of undetected cell internal defects. These defects may or may not be detected during normal operational evaluation, test, and validation. This may lead to unsafe conditions when operating in service.

These problems experienced by users of lithium batteries raise concern about the use of these batteries in commercial aviation. The intent of the special condition is to establish appropriate airworthiness standards for lithium battery installations in the Model PC-12, PC-12/45, and PC-12/47 airplanes and to ensure, as required by §§ 23.1309 and 23.601, that these battery installations are neither hazardous nor unreliable.

In summary, the lithium battery installation will consider the following items:

(a) The flammable fluid fire protection requirement is § 23.863. In the past, this rule was not applied to batteries of normal, utility, acrobatic, and commuter category airplanes since the electrolytes utilized in Ni-Cd and lead-acid batteries are not flammable.

(b) New Instructions for Continuous Airworthiness that include maintenance requirements to ensure that batteries used as spares have been maintained in an appropriate state of charge and installed lithium batteries have been sufficiently charged at appropriate intervals. These instructions must also describe proper repairs, if allowed, and battery part number configuration control.

(c) The applicant must conduct a system safety assessment for the failure condition classification of a failure of the battery charging and monitoring functionality (per Advisory Circular AC 23.1309-1E 2 ), and develop mitigation to preclude any adverse safety effects. Mitigation may include software, Airborne Electronic Hardware (AEH) or a combination of software and hardware, which should be developed to the appropriate Design Assurance Level(s) (DALs), respectively (per Advisory Circular AC 20-115C 3 and Advisory Circular AC 20-152 4 ).

(d) New requirements, in the proposed special conditions section, address the hazards of overcharging and over-discharging that are unique to lithium batteries, which should be applied to all rechargeable lithium battery and battery installations on the Model PC-12, PC-12/45, and PC-12/47 airplanes in lieu of the requirements of § 23.1353(a)(b)(c)(d)(e), amendment 23-49.

As discussed above, these special conditions are applicable to the Model PC-12, PC-12/45, and PC-12/47 airplanes. Should Finnoff Aviation apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A78EU 5 to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well.

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

1. Installation of Lithium Batteries must show compliance to the following requirements:

(1) Safe cell temperatures and pressures must be maintained during—

i. Normal operations;

ii. Any probable failure conditions of charging or discharging or battery monitoring system;

iii. Any failure of the charging or battery monitoring system not shown to be extremely remote.

(2) The rechargeable lithium battery installation must be designed to preclude explosion or fire in the event of (1)(ii) and (1)(iii) failures.

(3) Design of the rechargeable lithium batteries must preclude the occurrence of self-sustaining, uncontrolled increases in temperature or pressure.

(4) No explosive or toxic gasses emitted by any rechargeable lithium battery in normal operation or as the result of any failure of the battery charging system, monitoring system, or battery installation which is not shown to be extremely remote, may accumulate in hazardous quantities within the airplane.

(5) Installations of rechargeable lithium batteries must meet the requirements of § 23.863(a) through (d) at amendment 23-34.

(6) No corrosive fluids or gases that may escape from any rechargeable lithium battery may damage surrounding structure or any adjacent systems, equipment, electrical wiring, or the airplane in such a way as to cause a major or more severe failure condition, in accordance with § 23.1309(c) at amendment 23-62 and applicable regulatory guidance.

(7) Each rechargeable lithium battery installation must have provisions to prevent any hazardous effect on structure or essential systems that may be caused by the maximum amount of heat the battery can generate during a short circuit of the battery or of its individual cells.

(8) Rechargeable lithium battery installations must have—

(9) Any rechargeable lithium battery installation functionally required for safe operation of the airplane must incorporate a monitoring and warning feature that will provide an indication to the appropriate flight crewmembers whenever the State of Charge (SOC) of the batteries has fallen below levels considered acceptable for dispatch of the airplane.

(10) The Instructions for Continued Airworthiness required by § 23.1529 at amendment 23-26 must contain maintenance requirements to assure that the battery has been sufficiently charged at appropriate intervals specified by the battery manufacturer and the equipment manufacturer that contain the rechargeable lithium battery or rechargeable lithium battery system. This is required to ensure that lithium rechargeable batteries and lithium rechargeable battery systems will not degrade below specified ampere-hour levels sufficient to power the aircraft system. The Instructions for Continued Airworthiness must also contain procedures for the maintenance of replacement batteries in spares storage to prevent the installation of batteries that have degraded charge retention ability or other damage due to prolonged storage at a low state of charge. Replacement batteries must be of the same manufacturer and part number as approved by the FAA.

(11) In showing compliance with the proposed special conditions herein, paragraphs (1) through (8), and the RTCA document, Minimum Operational Performance Standards for Rechargeable Lithium Battery Systems, DO-311, may be used. The list of planned DO-311 tests should be documented in the certification or compliance plan and agreed to by the Denver ACO. Alternate methods of compliance other than DO-311 tests must be coordinated with the directorate and Denver ACO.

The current regulations in part 511 (21 CFR part 511) prohibit a disqualified clinical investigator from conducting any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. We propose to expand the current clinical investigator disqualification regulations in part 511 by providing that a disqualified investigator also is ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. In this document, consistent with our proposal in part 58 (21 CFR part 58) published elsewhere in this issue of the Federal Register, the term “nonclinical laboratory study” means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions or in the applicable environment to determine their safety or toxicity or both. The term does not include studies involving human subjects, clinical studies, or clinical investigational use in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or basic exploratory studies to determine the physical or chemical characteristics of a test article.

Under current § 511.1(c) (21 CFR 511.1(c)), a clinical investigator disqualified by the Commissioner is ineligible to receive the test article regulated in part 511 (i.e., a new animal drug for investigational use). Also, under the current regulations in § 511.1(c), a disqualified clinical investigator is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. However, under the current regulations, a disqualified clinical investigator continues to be eligible to conduct a nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

In order to conclude that a clinical investigator is no longer eligible to receive new animal drugs for investigational use, the Commissioner must find that the investigator repeatedly or deliberately failed to comply with the conditions of the exempting regulations or repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report (§ 511.1(c)(2)). When a clinical investigator is disqualified under part 511, the basis for disqualification typically is the repeated or deliberate submission of false information to FDA or a sponsor in a required report. For new animal drugs, the same clinical investigator could conduct both nonclinical laboratory studies and clinical investigations.

In the new animal drug approval process, nonclinical laboratory studies such as those for target animal safety and human food safety may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. Therefore, this proposal to expand § 511.1(c) to include nonclinical laboratory studies is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA for the approval of a new animal drug.

Consistent with the proposed changes to the provisions in part 511, we propose amending the list of regulatory provisions under which a part 16 (21 CFR part 16) informal regulatory hearing is available. In part 16, we propose changing the scope of the relevant provision for part 511 to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.”

Concurrent with this proposal, FDA is publishing elsewhere in this issue of the Federal Register a related provision in part 58. We propose in § 58.206 (21 CFR 58.206) that a disqualified person under part 58, who is a clinical investigator, would be notified that they are ineligible to receive a test article under part 511. Thus, where this part 511 proposal would make a disqualified clinical investigator ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug, the proposal in § 58.206 would make a disqualified person under part 58, who is a clinical investigator, ineligible to receive a test article under part 511. An investigator ineligible to receive a test article under part 511 also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. We propose this action in § 58.206 to help protect the safety and welfare of animal research subjects involved in FDA-regulated nonclinical laboratory studies and clinical investigations, and to help ensure the reliability and integrity of the data submitted to FDA to support FDA decisions concerning new animal drugs.

FDA may consider disqualification of a clinical investigator when FDA has information that an investigator has repeatedly or deliberately failed to comply with applicable requirements for the conduct of clinical investigations, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report. Disqualification of an investigator is initiated by the appropriate FDA Center depending upon the particular type of test article (e.g., new animal drug for investigational use) under study by the investigator in the clinical investigation. For example, the Center for Veterinary Medicine (CVM) may pursue disqualification of a clinical investigator who conducted a new animal drug clinical investigation and allegedly submitted to FDA or the sponsor false information in a required report.

The regulations provide the investigator, who is subject to disqualification, an opportunity to be heard and explain the matter complained of, i.e., explain the alleged violations. If the explanation offered is not accepted by the Center, the investigator will be given an opportunity for an informal regulatory hearing under part 16. After evaluating all available information, including any explanation presented by the investigator, the Commissioner issues a Commissioner's decision regarding the eligibility of the investigator to receive a particular type of test article (e.g., a new animal drug for investigational use). When disqualified by a Commissioner's decision, the investigator is no longer eligible to receive the particular type of test article under study when the violations occurred (e.g., new animal drugs). Also, under current regulations, an investigator disqualified by a Commissioner's decision is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

Because CVM regulates drugs for animal use, the study subjects are animals in both nonclinical laboratory studies and clinical investigations intended to support the approval of a new animal drug. Nonclinical laboratory studies such as those for target animal safety and human food safety may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. For animal drug products regulated by CVM, the same investigator may conduct both nonclinical laboratory studies and clinical investigations. For example, CVM's two most recent clinical investigator disqualification matters involved investigators who were also study directors on nonclinical laboratory studies submitted to CVM in support of applications for a new animal drug. In addition, CVM is aware of multiple persons that conduct both clinical investigations and nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. Therefore, it is critical for CVM to have the authority to disqualify an investigator from conducting nonclinical laboratory studies when that same investigator is disqualified from conducting clinical investigations, particularly when the basis for disqualification is the repeated or deliberate submission of false information to FDA or the sponsor in a required report.

This proposal to amend part 511 to expand a disqualified investigator's ineligibility to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug would help to ensure adequate protection of animal research subjects and data integrity. This action also may lead to improved public confidence in the nonclinical and clinical data supporting FDA decisions for new animal drug approvals.

We therefore propose that when the Commissioner determines that a clinical investigator is ineligible to receive the test article under the disqualification regulations in part 511 and is therefore ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, the investigator also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.

To effect this change, FDA proposes to amend the current regulations in § 511.1(c).

Proposed Revisions to § 511.1(c)(1): We propose to change the scope of the question addressed during a part 16 hearing, should the investigator request and be granted an informal hearing, also to include whether the investigator is eligible to conduct any nonclinical laboratory study that is intended to support an application for a research or marketing permit for a new animal drug.

Proposed Revisions to § 511.1(c)(2): We propose that an investigator disqualified by a Commissioner's decision also will be ineligible to conduct any nonclinical laboratory study that is intended to support an application for a research or marketing permit for a new animal drug.

Therefore, as proposed, an investigator determined to be ineligible to receive a test article under part 511 also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. This proposal expands the scope of the current regulations in § 511.1(c)(2) which states that a disqualified clinical investigator is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

FDA proposes amending § 511.1(c)(6) for consistency with our proposal to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug” to the part 511 investigator disqualification regulations. Therefore, for consistency with the proposed changes in § 511.1(c)(2), we propose adding in § 511.1(c)(6) that the investigator has presented adequate assurances that the investigator will conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug solely in compliance with the applicable provisions of chapter I.

We propose to revise § 16.1(b)(2) to amend the entry for § 511.1(c)(1) to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug” to be consistent with the other proposed amendments in this rulemaking.

We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. Section 512(j) of the FD&C Act (21 U.S.C. 355(j)) authorizes FDA to issue regulations for exempting from the operation of section 512 of the FD&C Act new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs. An investigator who repeatedly or deliberately violates the regulations or who repeatedly or deliberately submits to FDA or the sponsor false information in a required report would not be considered a qualified expert with the experience required to conduct nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. This proposed rulemaking would disqualify a clinical investigator from conducting nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug when the Commissioner determines that a clinical investigator is ineligible to receive the test article under the disqualification regulations in part 511. FDA's legal authority to promulgate this proposal regarding clinical investigators exists under sections 512(j) and 701(a) of the FD&C Act, as essential to protection of the public health and safety and to enforcement of the Agency's responsibilities under sections 201, 501, 502, 503, 512, and 701 of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 360b, and 371).

FDA proposes that any final rule that may issue based on this proposal become effective 30 days after the date of publication of the final rule in the Federal Register.

FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule does not impose new requirements on any entity and therefore has no associated compliance costs, the Agency proposes to certify that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.

This proposed rule seeks to expand the scope in part 511 of disqualification of a clinical investigator to include ineligibility to conduct nonclinical laboratory studies. A final rule (77 FR 25353), published on April 30, 2012, prevents a disqualified investigator from conducting any clinical investigation, and therefore applies explicitly to clinical investigations. However, the rule is silent on nonclinical laboratory studies. Thus, under the current regulation in part 511, a disqualified investigator could conduct a nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. Because the reason typically for disqualification in part 511 is the repeated or deliberate submission of false information to FDA or a sponsor in a required report, preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is essential to adequate protection of animal research subjects and data integrity.

The Agency would not incur additional costs by expanding the scope in part 511 for disqualification of a clinical investigator. Similarly, we do not expect that industry would incur additional costs because the proposed rule would not require sponsors to perform additional tasks. For instance, upon disqualification, the respective investigator's name is posted on FDA's Web page, and this helps mitigate the employment of the investigator for clinical investigations or nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. Because the typical reason for disqualification in part 511 is the repeated or deliberate submission of false information to FDA or a sponsor in a required report, the benefit of preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is enhanced protection of animal research subjects and data integrity.

FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule, if finalized, would not contain policies that would 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. Accordingly, the Agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that parts 16 and 511 be amended as follows:

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production.

Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in section 418 of the FD&C Act (21 U.S.C. 350g), by adding requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations, in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement these requirements within part 117 (21 CFR part 117).

We are announcing the availability of several chapters of a multi-chapter draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

The multi-chapter draft guidance for industry is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under part 117, principally in subparts C and G. The chapters that we are announcing in this document are as follows:

We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB control number 0910-0751.

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

FDA proposes to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision is being proposed to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by the FDA Center for Veterinary Medicine (CVM) to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobial drugs in animal agriculture. Under this program, sponsors of antimicrobial new animal drugs that also have importance in human medicine were requested to voluntarily withdraw approval of production (e.g., growth production, feed efficiency) indications for their drug products that are intended for use in the feed or water of food-producing animals. Based on the existing drug category definitions, the voluntary withdrawal of production indications by these drug sponsors would, in some cases, result in a change to a medicated feed drug's category, potentially leading to additional consequences not foreseen at the time the program was initiated.

The category in which a new animal drug used in medicated feeds is placed is based on their likelihood of producing unsafe residues in the edible products of treated animals. Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.

New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.

Certain Category I Type A medicated articles would be recategorized to Category II when a production indication is voluntarily withdrawn by a sponsor as part of the judicious use initiative that is currently underway, based on the next lowest use level that remains once the production use is withdrawn having a withdrawal period such that the drug would then meet the definition for Category II. For Category I Type A medicated articles that include indications for minor species, FDA is concerned that if such a Type A medicated article is recategorized to Category II based on a withdrawal period for an approved therapeutic use in a minor species, sponsors may opt to request withdrawal of approval of these minor species indications in order to ensure the Type A medicated article can remain in Category I. Sponsors may also decline to pursue development of additional therapies for minor species if these uses would require a withdrawal period that would trigger a recategorization to Category II.

The proposed revisions would revise the category definitions such that they would be based only on whether a withdrawal period is required for a major species.1 Under the proposed definition, a Category I Type A medicated article would not be recategorized to Category II based on the existence of a withdrawal period for an approved indication in a minor species, even if that minor species indication is the next lowest approved use level that remains after the production indication has been withdrawn. However, if the next lowest use level (apart from the minor species indication) is an indication approved for use in a major species that has a withdrawal period, under the new definition the drug would move to Category II.

The purpose of the proposed revision is to preserve the present availability of medicated feeds intended for therapeutic use in minor species and to prevent a significant disincentive for future development of additional therapies for minor species. We believe the proposed revision will not compromise public health due to the comparatively lower exposure by humans to potential drug residues in edible tissues of food-producing minor species inherent in their less frequent consumption.

FDA proposes to amend 21 CFR 558.3 Definitions and general considerations applicable to this part (§ 558.3) to base the definition for each of the two categories (Category I and Category II) of new animal drugs used in medicated feeds only on approved uses in major species. Definitions for “major species” and “minor species” are also being added to this section.

We are proposing these regulations based on our authority under the new animal drug provisions in section 512 (21 U.S.C. 360b) and section 701 (21 U.S.C. 371) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) which gives the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

The revisions made by this proposed rule are intended to preserve the availability of medicated feeds intended for therapeutic use in minor animal species. In addition, these proposed revisions will prevent a significant disincentive for future development of additional therapies for minor species. No additional costs or benefits will accrue from this rulemaking.

FDA is proposing to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. To strengthen the Agency's medicated feed program, FDA issued a final rule in the Federal Register of March 3, 1986 (51 FR 7382), which, among other things, established two categories of new animal drugs used in medicated feeds. As discussed in the final rule, the Agency placed these drugs into categories based on their likelihood of producing unsafe residues in the edible products of treated animals (51 FR 7382). Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.

New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.

This action is being taken to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by CVM to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobials of importance to human medicine (i.e., medically important antimicrobials) in animal agriculture. Specifically, CVM's initiative to ensure the judicious use of medically important antimicrobial drugs in animal agriculture advocates two specific changes to the approved conditions of use of medically important antimicrobials that are administered through the medicated feed or water of food-producing animals.

These changes, which are described in Guidance for Industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” published December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), are intended to reduce the development of antimicrobial resistance and thereby preserve the effectiveness of these important drugs for use in treating infections in humans. Following publication of GFI #213, all sponsors of these medically important antimicrobial new animal drug products approved for use in the feed or water of food-producing animals notified FDA in writing of their intent to voluntarily make changes to their affected products as outlined in the guidance.

Under GFI #213, sponsors of medically important antimicrobial new animal drugs approved for over-the-counter use in the feed or water of food-producing animals were asked to change the marketing status of their products to veterinary prescription (Rx) marketing status in the case of new animal drugs administered in water, or to veterinary feed directive (VFD) marketing status for drugs administered in or on animal feed. New animal drugs with Rx or VFD marketing status can legally only be used with a veterinarian's oversight. Prescription animal drugs require a veterinarian's prescription, while use of VFD drugs requires a VFD; both types of orders must be issued by a licensed veterinarian in the course of the veterinarian's professional practice.

In addition, under GFI #213 sponsors of medically important new animal drugs used in animal feed or water that have production indications were requested to voluntarily withdraw these indications; approved therapeutic indications for use of these drugs would remain.

In some instances, once a sponsor withdraws the production indication from a drug approved for use in animal feed (which is generally the lowest use level of the drug), the remaining lowest therapeutic use level will require a withdrawal period. Based on the existing definitions of the feed drug categories, this results in a Category I new animal drug being recategorized as a Category II drug, the more restrictive of the two possible categories of drugs used in medicated feed. Category II drugs require that the manufacture of Type B and Type C medicated feeds from Type A medicated articles be done in facilities possessing a medicated feed mill license, which number roughly 900 in the United States. In contrast, there are tens of thousands of unlicensed feed mills in this country. Such a recategorization to Category II, thereby limiting the use of the Type A medicated article to a much smaller subset of feed mills, may disrupt the existing movement of these medicated feeds through distribution channels.

FDA believes that sponsors may request voluntary withdrawal of those specific therapeutic indications as a way to keep their products in the less restrictive Category I when the recategorization of a drug to Category II is triggered by a therapeutic indication for a minor species. For certain drug products, the only therapeutic indications requiring a withdrawal period that would remain following the voluntary withdrawal of approval of production uses are those for minor species. The loss of therapeutic indications for minor species would adversely affect the availability of therapeutic medicated feeds necessary for the health of minor species, which is a matter of significant concern for the Agency.

This foreseeable adverse effect on the health of minor species would directly undermine the intent of Congress in passing the Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) as well as to our intent in establishing the implementing regulations under that statute. The Category I drugs likely to be affected have been safely used in this category for decades, and we have no reason to believe they would not continue to be safely used in this category moving forward.

Under the current category definitions in § 558.3 for feed use drugs, a drug will be included in Category II if the lowest use level of the drug in any approved species requires a withdrawal period. This approach equates the existence of a withdrawal period for a particular use with the potential risk that edible tissues from animals administered a medicated feed might contain a residue of concern.

However, the toxicological analysis of animal drugs used to calculate a withdrawal period is based on lifetime exposure by humans to potential drug residues. This assessment of lifetime exposure does not consider the lower risk to the public health from the use of these same new animal drugs in food-producing minor species attributable to the lower human consumption over time of edible tissues from food-producing minor species (Refs. 1 and 2). For this reason, FDA does not at this time believe this revision of the category definitions presents a risk to the public health.

In a manner similar to its effect on drug indications that are already approved, CVM believes the existing categorization scheme would pose a significant disincentive for future development of additional minor species therapies for existing Category I drugs if those new uses would require a withdrawal period and thus trigger a change to Category II for that drug.

Given the potential for implementation of GFI #213 to result in the foreseeable consequence of the withdrawal of approval of needed therapeutic indications for minor species, we propose to revise the definitions of the two categories of new animal drugs used in medicated feeds in § 558.3 to base category assignment only on uses in major species. This proposed revision is expected to preserve the availability of drugs intended for therapeutic use in minor species and also prevent a significant disincentive for future development of additional therapies for minor species without compromising public health.

FDA proposes to amend paragraphs (b)(1)(i) and (ii) of this Agency's regulations at § 558.3 (Definitions and general considerations applicable to this part) to base the definition for each of the two categories (Category I and Category II) of new animal drugs used in medicated feeds only on approved uses in major species. We further propose to amend § 558.3(b) by adding definitions for “major species” and “minor species” that are identical to the definitions of those terms found in FDA's regulations for new animal drugs for minor use and minor species (21 CFR 516.3). We are proposing to revise the feed drug category definitions in § 558.3 to preserve the availability of medicated feeds intended for use in minor species and to prevent a likely disincentive for development of additional therapies for minor species.

This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register. FDA proposes to amend § 558.3(b)(1) to revise the definitions of Category I and Category II new animal drugs administered in medicated feed. This proposed rule is intended to make noncontroversial changes to existing regulations. The Agency does not anticipate receiving any significant adverse comment on this rule.

Consistent with FDA's procedures on direct final rulemaking, we are publishing elsewhere in this issue of the Federal Register a companion direct final rule. The direct final rule and this companion proposed rule are substantively identical. This companion proposed rule provides the procedural framework within which the rule may be finalized in the event the direct final rule is withdrawn because of any significant adverse comment. The comment period for this proposed rule runs concurrently with the comment period of the companion direct final rule. Any comments received in response to the companion direct final rule will also be considered as comments regarding this proposed rule.

FDA is providing a comment period for the proposed rule of 75 days after the date of publication in the Federal Register. If FDA receives a significant adverse comment, we intend to withdraw the direct final rule before its effective date by publication of a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, the Agency will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553).

Comments that are frivolous, insubstantial, or outside the scope of the proposed rule will not be considered significant or adverse under this procedure. For example, a comment recommending a regulation change in addition to those in the proposed rule would not be considered a significant adverse comment unless the comment states why the proposed rule would be ineffective without the additional change.

If FDA does not receive significant adverse comment in response to the companion direct final rule, the Agency will publish, within 30 days after the comment period ends, a document in the Federal Register confirming the effective date of the final rule. The Agency intends to make the direct final rule effective on December 1, 2016.

A full description of FDA's policy on direct final rule procedures may be found in a guidance document announced in the Federal Register of November 21, 1997 (62 FR 62466). The guidance document may be accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

We are proposing these regulations under the legal authority provided by section 512 of the FD&C Act relating to new animal drugs and section 701(a) of the FD&C Act. Section 512 gives FDA the authority to approve new animal drug applications (NADAs). Such approval establishes conditions of use under which the drug can be used in a safe and effective manner. Categorization of new animal drugs used in medicated feeds is one such condition of use. In addition, section 701(a) of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would not impose any compliance costs on the sponsors of animal drug products that are currently marketed or in development, we propose to certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

This proposed rule allows certain new animal drugs approved for use in animal feed that would otherwise be recategorized as Category II drugs under the current definitions in § 558.3 following withdrawal of approval of production indications during GFI #213 implementation to remain in Category I if the change to Category II would have been triggered by a minor species indication.

Based on the revised definitions of the two feed drug categories, there is one drug, sulfamerazine for control of furunculosis in trout (21 CFR 558.582), that would be recategorized from Category II to Category I as a result of this proposed rule, if finalized. No compliance costs would be incurred due to this recategorization because no changes to the approved application are required for continued marketing of the drug.

We have determined under 21 CFR 25.30(h) that this action is of a type that will not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that 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. Accordingly, we have concluded that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.)

Therefore, under the Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, it is proposed that part 558 be amended as follows:

The information presented in this document is organized as follows:

Entities potentially affected directly by the proposed revisions to the EPA's regulations include anyone who intends to submit a title V petition on a proposed title V permit prepared by a state, local or tribal title V permitting authority pursuant to its EPA-approved title V permitting program. Entities also potentially affected by this rule include state, local and tribal permitting authorities responsible for implementing the title V permitting program. Entities not directly affected by this proposed rule include owners and operators of major stationary sources or other sources that are subject to title V permit requirements, as well as the general public who would have an interest in knowing about title V permitting actions and associated public hearings but do not intend to submit a petition.

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

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

To request a public hearing or information pertaining to a public hearing, contact Ms. Pamela Long, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, by phone at (919) 541-0641 or by email at [email protected].

In addition to being available in the docket, an electronic copy of this Federal Register document will be posted at the regulations section of our Title V Operating Permits Web site, under Regulatory Actions, at http://www.epa.gov/title-v-operating-permits/current-regulations-and-regulatory-actions. A “track changes” version of the full regulatory text that incorporates and shows the full context of the proposed changes to the existing regulations in this proposal is also available in the docket for this rulemaking.

Title V of the CAA establishes an operating permit program. Section 505 of the CAA requires permitting authorities to submit a proposed title V permit to the EPA Administrator for review for a 45-day review period before issuing the permit as final. The Administrator shall object to issuance of the permit within that 45-day review period if the Administrator determines that the permit contains provisions that are not in compliance with the applicable requirements under the CAA. If the Administrator does not object to the permit during the 45-day EPA review period, any person may petition the Administrator within 60 days after the expiration of the 45-day review period to take such action (hereinafter “title V petition” or “petition”). The title V petition provisions of the current implementing regulations found at 40 CFR part 70 largely mirror the CAA, and have not been revised since original promulgation in 1992. With 20 years of experience with title V petitions as well as feedback from various stakeholders, the agency is now proposing changes to 40 CFR part 70 intended to provide clarity and transparency to the petition process, and to improve the efficiency of that process.1

The changes proposed and the information provided in the preamble to the proposal are intended to benefit permitting authorities, permitted sources, and potential petitioners, as well as the EPA. Permitting authorities and permitted sources are expected to benefit by early consultation with the appropriate EPA Regional Office when the permitting authority is preparing a permit to ensure it includes conditions that assure compliance with applicable requirements under the CAA and part 70). These early actions should minimize potential permit deficiencies and reduce the associated likelihood that a petition will be submitted on that title V permit.

Potential petitioners are expected to benefit by having better notification of permits and review deadlines (e.g., the EPA is proposing to post on EPA Regional Web sites when a proposed permit is received and the corresponding 60-day deadline for submitting a petition) and by better access to permitting decision information (e.g., the permitting authority's written response to comments). These updates will clarify the expected minimum content of petitions and provide a standardized format, simplifying the process and enhancing the likelihood that petitions will be clear and complete. In addition, potential petitioners may also derive a benefit from more efficient responses to petitions and a better understanding of the process.

The EPA is expected to benefit by improving the agency's ability to meet its statutory obligations to review proposed permits, respond to title V petitions and provide more transparency in the title V petition process. These were concerns expressed by a Clean Air Act Advisory Committee task force in recommendations provided to the agency in 2006.2 The EPA believes that the proposed regulatory revisions and shared information are responsive to these concerns and could, if finalized, improve the efficiency of the agency's response.

The proposed regulatory revisions described in Section IV of this notice would, among other things: (1) Provide direction as to how title V petitions should be submitted to the agency, including encouraging the use of an electronic submittal system as the preferred (but not exclusive) method to submit title V petitions; (2) describe mandatory content and format for title V petitions, which is intended to clarify the process for petitioners and improve the EPA's ability to review and act on petitions efficiently; and (3) require permitting authorities to respond in writing to significant comments received during the public comment period on a draft title V permit and to provide that written response to the EPA along with the proposed title V permit at the start of the EPA's 45-day review period. This proposal also requests comment on the proposed revisions to the regulations governing the CAA title V petition process, as well as comment on questions related to potentially establishing page limits on title V petitions. The proposed revisions to the 40 CFR part 70 regulations are described more fully in Section IV of this notice.

Separate from the regulatory revisions proposed in Section IV, Section V.A of this notice provides guidance on “recommended practices” for permit development for various stakeholders that, when followed, helps to ensure permits have complete administrative records and comport with the requirements of the CAA. Lastly, to increase stakeholder familiarity with the post-petition process, Section V.B. provides information concerning the agency's interpretation of certain provisions of title V of the CAA and the implementing regulations at part 70 regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders. The following paragraphs briefly provide additional information on each area.

First, in order to reduce confusion with and add clarity to the process of submitting title V petitions, the EPA has developed a centralized point of entry for all title V petitions using an electronic submittal system. As described in Section IV.A of this notice, the EPA encourages petitioners to use this electronic system when submitting title V petitions, which will improve customer service by allowing for better access to and tracking of petitions. This is the preferred method identified in the proposed regulatory revisions that would be acceptable to use to submit a title V petition to the agency. Alternative methods for submittal are also identified in this notice.

Second, with regard to petition content, the EPA is proposing regulatory revisions that would specify requirements for mandatory petition content and standard formatting for all petitions. This is expected to benefit potential petitioners by ensuring completeness while promoting streamlining and improving the EPA's ability to review and act on petitions efficiently. In its orders responding to title V petitions, the EPA has already identified key elements that are critical for demonstrating that a title V permit does not assure compliance with applicable requirements under the CAA or under the part 70 regulations, and has explained their relevance to its determinations. In this proposal, the EPA is proposing new regulatory language to codify what has already been discussed in prior orders. If finalized, petitioners would be expected to follow these requirements and include this content following a standard format. As described later in this notice and in the proposed regulatory text, this content includes identifying where the issue being raised in the title V petition was raised during the public comment period on the draft title V permit and addressing the permitting authority's response to the comment in the petition in order to demonstrate that an objection is warranted.

Along with the proposed changes and requests for comment regarding petition content and format in Section IV.B of this notice, the EPA proposes to add new regulatory language to 40 CFR 70.8 that would require a petitioner to send a copy of the petition to both the permitting authority and the permit applicant. The current title V regulations do not have provisions implementing this requirement of section 505(b)(2) of the Act. Therefore, this rule proposes to insert a requirement into the part 70 rules mirroring the Act's requirement in order to ensure consistency with this provision of the statute.

Third, Section IV.C of this notice contains requirements for certain procedures related to responding to significant public comments on the draft title V permit, as well as the administrative record for and submittal of proposed title V permits to the EPA by permitting authorities. The changes being proposed now would require that all permitting authorities respond to significant comments received on draft permits. The EPA is also proposing that the 45-day review period under section 505(b)(1) would not begin until the permitting authority forwards the proposed permit, the written response to comments (RTC) or statement that no public comments were received, and the statement of basis document, to the EPA for its review. These changes are expected to benefit permitting authorities and permitted sources by resulting in a more complete permit record and greater clarity for all stakeholders. If finalized, these changes may result in a need to revise at least some state, local and tribal part 70 programs.

In addition to these three areas, as part of the agency's effort to share information with stakeholders about the title V petition process, this notice includes guidance to help ensure permits have complete administrative records and comport with the requirements of the CAA. Presented in the form of “recommended practices” for stakeholders, this guidance is shared in the spirit of providing information and context to give a more comprehensive view of the title V petition process, including the time before a petition may be filed. Following the suggested recommended practices contained in Section V.A of this notice is expected to positively affect the permit issuance process resulting in better permits and may reduce the likelihood that a title V petition will be submitted on a title V permit.

All four of the previously mentioned areas should help to improve title V permits issued by permitting authorities, promote access to and provide better understanding of the title V petition process for potential petitioners, and reduce delays in decisions and support the agency's efforts to meet its obligations in responding to title V petitions. The proposed revisions to the part 70 regulations associated with the first three key areas are anticipated to increase transparency and add clarity to the title V petition submittal, review, and response processes. Codifying existing practices into title V regulations of the CAA is also expected to make the EPA petition review process more efficient. In addition, providing “recommended practices” for stakeholders, including some related to permit issuance, also increases transparency and clarity to further improve the stakeholder experience and understanding surrounding title V petitions.

Section V.B of this notice discusses steps following the EPA's issuance of an objection in response to a title V petition, particularly where the state, local, or tribal permitting authority subsequently amends the permit terms and conditions and/or the permit record in response to the EPA's objection. This process is often referred to as the post-petition process. The information provided in Section V.B reflects interpretations of certain statutory and regulatory provisions related to this aspect of the title V petition process that have previously been discussed by the EPA, including in title V petition orders. This information is repeated as a convenience to stakeholders and the general public: The agency is not proposing to alter its interpretation of that process in this notice and the regulatory revisions proposed in this notice do not relate to or modify this interpretation. The agency is not soliciting comment on this interpretation or otherwise reopening or revising the already-issued title V petition orders or other EPA documents in which it has previously been discussed. Rather, this discussion is included to provide additional transparency and clarity.

Finally, as a convenience to stakeholders and the general public, and to provide context and background that informs how the EPA determines whether to grant an objection and to promote awareness of the EPA's existing interpretation of key provisions of section 505(b)(2) of the Act, Section III.D of this notice includes a summary of some past orders responding to title V petitions and court decisions addressing the burden on a title V petitioner to demonstrate that an objection is warranted.

Congress amended the CAA in 1990 to add title V, now found at 42 U.S.C. 7661-7661f, to assist in compliance and enforcement of air pollution controls. CAA Amendments of 1990, Public Law 101-549, sections 501-507, 104 Stat. 2399, 2635-48 (1990). Before this, the CAA pollution control requirements that might apply to a particular source could be found in many different provisions of the Act and its numerous regulations. As one court opinion has described it: “Before 1990, regulators and industry were left to wander through this regulatory maze in search of the emission limits and monitoring requirements that might apply to a particular source. Congress addressed this confusion in the 1990 Amendments by adding title V of the Act, which created a national permit program that requires many stationary sources of air pollution to obtain permits that include relevant emission limits and monitoring requirements.” Sierra Club v. EPA, 536 F.3d 673, 674 (D.C. Cir. 2008).

Accordingly, title V of the Act establishes an operating permits program for major sources of air pollutants, as well as certain other sources. CAA section 502(a). Under title V of the CAA, states were required to develop and submit to EPA for approval title V permitting programs consistent with program requirements promulgated by the EPA. Those requirements are now found in 40 CFR part 70. Most states, certain local agencies, and one tribe have approved part 70 programs.3 As part of an approved part 70 program, title V of the CAA requires every major source and certain other sources to apply for and operate pursuant to an operating permit. CAA sections 502(a) and 503; see also 40 CFR 70.5(a) and 70.1(b). It further requires that the permits contain conditions that assure compliance with all of the sources' applicable requirements under the Act, including the requirements of the applicable implementation plan. CAA section 504(a); see also 40 CFR 70.1(b) and 70.6(a)(1).

Prior to the title V program, CAA requirements for major sources of air pollutants were implemented in multiple and various ways. As a lawmaker involved in the 1990 CAA Amendments explained:

More specifically, a title V permit must contain enforceable emission limits and standards, including operational requirements and limitations, and such other conditions as necessary to assure compliance with all applicable requirements that apply to the source at the time of permit issuance, as well as the monitoring, recordkeeping, and reporting requirements to assure compliance. In sum, the title V permit program is a vehicle for ensuring that air quality control requirements are appropriately applied to a source's emission units and for assuring compliance with such requirements.

For the most part, title V of the CAA does not impose new pollution control requirements on sources. The definition of “applicable requirements” in the part 70 regulations includes many standards and requirements that are established through other CAA programs, such as standards and requirements under sections 111 and 112 of the Act, and terms and conditions of preconstruction permits issued under the New Source Review programs. 40 CFR 70.2. Once those air quality control requirements are established in those other programs, they are incorporated into a source's title V permits as appropriate. Hence, a title V permit is a comprehensive document that identifies all the specific CAA requirements that must be met by a source in order to operate. Developing such a comprehensive document can be a complex process that involves some harmonization of all the source's applicable requirements. As a lawmaker involved in the 1990 CAA Amendments explained:

As this language suggests, in providing an opportunity for harmonization through title V of the CAA, Congress did not replace or remove the procedures and requirements for establishing substantive requirements that exist in other provisions of the CAA. Nor did Congress alter or supplant the opportunities for public participation and administrative and judicial review that are found in other CAA programs, such as those for public participation and judicial review of certain final agency actions under section 307 of the Act. In addition, the Act requires that title V permitting programs provide opportunities for public participation in title V permitting processes and an opportunity for judicial review in state court. CAA section 502(b)(6); see also 40 CFR 70.4(b)(3)(x) (judicial review) and 70.7(h) (public participation). The petition process co-exists with those provisions, without superseding them.

Although title V of the CAA does not generally impose new pollution control requirements on sources, it does require that certain procedural measures be followed especially with respect to assuring compliance with underlying applicable requirements, and it also requires sources to pay certain fees. For example, title V of the CAA requires permits to contain adequate monitoring, recordkeeping, and reporting provisions to assure sources' compliance with permit terms and conditions. See CAA 504(c); Sierra Club v. EPA, 536 F.3d 673 (D.C. Cir. 2008). The part 70 regulations contain monitoring rules designed to satisfy this statutory requirement. Finally, as an additional measure to ensure permits are in compliance with the CAA, the title V program provides for public participation at various steps in the permitting process, including the opportunity to submit a title V petition.

In general terms, as noted above, the title V permit program was a significant development that established new procedural requirements for permitting authorities and sources. In crafting the program, Congress balanced the benefit of a single document that contains all applicable requirements of the Act with the need to process these complex documents in an efficient manner. As part of the effort to promote efficient implementation of the operating permits program, the provisions relating to title V objections establish an orderly process with specific deadlines, which give the EPA an opportunity to raise objections to a title V permit before it is issued and which give any person the opportunity to timely raise specific issues to the EPA through a title V petition. In light of the complexities of implementing a program of title V's scope, a statement of one lawmaker in the legislative history indicates that the opportunity to “challenge EPA's failure to object” through the petition process was “designed to avoid delays” while preserving the discretion of both the EPA and the states.6

More specifically, under CAA section 505(a), and the current implementing regulations found at 40 CFR 70.8(a), permitting authorities are required to submit each proposed title V permit to the EPA for review.7 Upon receipt of a proposed permit and all necessary supporting information, the Administrator has 45 days in which to object to the final issuance of the permit if he/she determines that the proposed permit is not in compliance with applicable requirements of the Act, including the requirements of the applicable state implementation plan (SIP), or part 70 requirements. CAA section 505(b)(1) and 40 CFR 70.8(c)(1).

As the EPA explained when proposing the initial title V regulations in 1991, the Act limits the EPA's opportunity for its initial review and an objection based on that review to 45 days in order to minimize delays. 56 FR 21749 (May 10, 1991). If the Administrator objects under CAA 505(b)(1), he/she must provide a statement of the reasons for the objection, providing a copy of both the objection and the statement to the permit applicant. CAA 505(b)(1); see also 40 CFR 70.8(c)(1).

If the Administrator does not object during the 45-day review period, consistent with section 505(b)(2) of the CAA and 40 CFR 70.8(d), any person may petition the Administrator within 60 days after the expiration of the EPA's 45-day review period to object to the permit. The Administrator shall grant or deny such a petition within 60 days after it is filed. CAA section 505(b)(2) establishes several requirements related to such petitions. Among other things, it provides that such a petition shall be based only on objections to the permit that were raised with reasonable specificity during the public comment period, unless the petitioner demonstrates that it was impracticable to raise objections during that period or the grounds for objection arose after completion of the public comment period. It also provides that the Administrator shall issue an objection if the petitioner demonstrates that the permit is not in compliance with the requirements of the CAA, including the requirements of the applicable implementation plan.

The implementing regulations are found in 40 CFR 70.8(d) and largely mirror this provision. As the EPA explained in proposing the initial title V regulations, the title V petition opportunity serves an important purpose because title V permits are frequently complex documents, and given the brevity of the agency review period there may be occasions when the EPA does not recognize that certain permit provisions are not in compliance with applicable requirements of the Act. 56 FR 21751 (May 10, 1991). CAA section 505(b)(2) states that the Administrator “shall” object if the petitioner makes the required demonstration. If the Administrator denies a petition for an objection, CAA 505(b)(2) provides that denial is subject to judicial review under CAA section 307; however, under CAA section 505(c), no objection is subject to judicial review until the Administrator has taken final action to issue or deny the permit. Further, the requirements under CAA section 505(b)(2) may not be delegated by the Administrator.

In addition to the provisions of title V, the rulemaking of provisions under CAA section 307(d) are relevant to this notice. The Administrator is applying the rulemaking provisions of CAA section 307(d) to the rulemaking discussed in this notice, pursuant to CAA section 307(d)(1)(V), which provides that the provisions of 307(d) apply to “such other actions as the Administrator may determine.”

After 20 years of experience in implementing the title V petition process, the EPA has identified some general trends in petition content and aspects of the petition review process that pose challenges for potential petitioners in preparing petitions and for the EPA in providing an efficient response to petitions. These are described in this section of the notice to provide additional context for this proposal. This proposed rulemaking is aimed in part at increasing stakeholder access to and understanding of the petition process and increasing the efficiency of the agency's response to petitions received and at mitigating some of the factors that contribute to poorly prepared or incomplete petitions, misunderstanding of applicable permit and CAA requirements, and longer response times. These factors include: (1) The lack of administrative requirements around petition submittals, which results in a variety of inconsistent methods used by petitioners; (2) the lack of specific rules regarding petition content, which results in considerable inconsistency in the format and content of petitions; and (3) the need to often deal with numerous and highly complex issues that arise in title V petitions given that title V permits must address many applicable requirements. These include issues relating to compliance with the requirements of the prevention of significant deterioration (PSD) permitting program, the hazardous air pollutant program (i.e., requirements implementing the provisions of CAA 112), and other air quality issues. For example, petitioners often raise issues related to compliance with the requirements of the major and minor preconstruction permit programs, such as the PSD permitting requirements found in part C of Title I of the Act. This permitting program has a separate process under the CAA, its implementing regulations and SIPs, for evaluating applicability of the permitting requirements, determining the appropriate terms and conditions for permits, and for public participation and administrative and/or judicial review of those permits. At times, the PSD issues raised in the context of a title V petition relate to projects that occurred a considerable time in the past, and in some situations, the title V permit record may not contain all the relevant information for understanding the determinations that were made. For these reasons, consideration of these issues in the title V petition context can be time-consuming to research and complex to resolve, even to come to the seemingly simple determination that the permit record is inadequate. Further, title V petitions frequently include lengthy arguments that primarily concern CAA programmatic or policy issues, rather than the terms of a particular permit.

Over time, petitions have raised increasingly more complex policy, legal, and technical matters. Through the review of such extensive and complicated petitions, the petition review process has evolved into a resource-intensive effort by the EPA. To increase stakeholder understanding of the title V petition process, help ensure consistent presentation of critical information in such petitions, and facilitate more efficient review of them, the EPA is proposing to revise its regulations to establish procedural parameters which, if finalized, would govern the title V petition process moving forward. As described in more detail in Section IV of this notice, this proposal includes proposed requirements for petition submittal, petition content and format, and certain administrative record requirements. As mentioned previously, one of the primary goals of the proposed changes is to improve stakeholder access to and understanding of the petition process and improve the agency's ability to meet its statutory obligations to review proposed permits and respond to title V petitions, in light of the overall structure of the CAA.

Yet another overarching factor that hampers the current petition review process is the confusion or lack of familiarity with the process itself. In the 2006 Title V Task Force Final Report noted earlier, for example, the CAAAC task force expressed a concern with the lack of transparency in the title V petition process. This concern has been echoed in the years since the 2006 report through feedback the agency has received from various stakeholders. In response, the EPA has tried to provide more explanation and insight into the title V petition process in the administrative orders it issues in responding to petitions. Some of these issues have also been discussed in the opinions courts have issued in reviewing such EPA orders. However, the EPA expects that not all stakeholders, including the public, may have read these response orders or related court decisions.

Therefore, the next section of this notice seeks to provide additional transparency concerning the petition process by repeating some of the relevant interpretations of statutory and regulatory provisions that the EPA has previously explained in title V petition orders, as well as interpretations of certain provisions related to the title V petition process provided in judicial opinions. Reiterating these prior statements concerning the EPA's application and interpretation of the statute to reviewing title V petitions may also provide useful context for the proposed changes to 40 CFR part 70, which are discussed in Section IV of this notice.

This section includes a discussion of certain aspects of the statutory elements of CAA section 505(b)(2) as well as the implementing regulations that have previously been interpreted by the EPA and/or courts. The discussion that follows serves to inform the public, stakeholders, permitting authorities, and other interested parties of these interpretations. Although the matters discussed in this section are available to the public,8 and in some cases have been available for years and/or already subject to judicial review, in the interest of transparency and clarity, the agency is collecting these interpretations and judicial decisions in this notice. That information is repeated here merely as a convenience for the public. The agency is not in this notice proposing to change these previously-presented interpretations, soliciting comments on these interpretations, or reopening the already-issued title V orders or other EPA documents in which these interpretations were discussed. None of the regulatory revisions proposed in this notice would alter these interpretations or the prior title V orders or other EPA documents in which these interpretations were discussed.

Certain of the requirements under CAA section 505(b)(2) related to petitions are sometimes referred to as “threshold” requirements, which provide some procedural requirements and some limitations on the scope of title V petitions. These include, for example, that the petition be filed within 60 days following the agency's 45-day review period. Another example is the requirement that the petition be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the permitting agency. The agency has previously addressed these “threshold” issues in prior title V orders, and some of those statements are reiterated in this section.

Generally speaking, the first step in the petition response process is for the agency to ascertain if the petition was timely filed pursuant to CAA section 505(b)(2). The Act and implementing regulations at 40 CFR 70.8(d) provide for a 60-day window in which to file a title V petition, which runs from the expiration of the EPA's 45-day review period. A petition received after the 60-day petition deadline is not timely. The agency is aware that because the petition period runs from the end of the EPA's 45-day review period, and the date a proposed permit is received by the EPA is not always apparent, the petition deadline is not always readily apparent. The agency currently encourages permitting authorities to provide notifications to the public or interested stakeholders regarding the timing of proposal of permits to the EPA, for example making that information available either online, such as Region 4 has done on the EPA Web site, “Region 4 Proposed Title V Permits and State Contacts,” 9 or in the publication in which public notice of the draft permit was given.

The second “threshold” requirement described in the statute regards the content of a petition. CAA section 505(b)(2) requires that, unless one of the enumerated exceptions applies, the petition must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the permitting agency. Subject to the exceptions contained in the provision, the EPA understands this statutory language to require that the issues presented in a petition be raised during the public comment process with reasonable specificity. Such issues could, however, be raised in comments filed by a commenter other than the petitioner.

The EPA continues to believe that, as stated in the preamble to the 1991 part 70 proposal, Congress did not intend for petitioners to create an entirely new record before the EPA that the permitting authority had no opportunity to address. The requirement to raise issues “with reasonable specificity” places the burden on the petitioner. Unless there are unusual circumstances, the Petitioner needs to provide evidence that would support a finding of noncompliance with the Act to the permitting authority before it is raised in a petition. See, 56 FR 21712, 21750 (1991).

Where an issue is raised to the EPA in a title V petition without first raising it with reasonable specificity to the permitting authority to give it the opportunity to address the issue, the Administrator has generally denied such claims consistent with the statutory requirements. The EPA has specifically addressed the reasonable specificity threshold requirement in a number of title V petition orders. Some key highlights are summarized next.

In 2013 in the Luminant Order, the EPA responded to a petition that raised a number of issues, including several that were raised only in general terms or not raised at all during the public comment period by any commenter. See, In the Matter of Luminant Generating Station, Petition, Order on Petition No. VI-2011-05 (January 15, 2013). For example, the petitioners claimed that the permit in question failed to identify emission units that were associated with permit by rules to which the facility was subject. The EPA noted that no mention was made in the public comments concerning the lack of identification of emission units, and denied the claim. Id. at 12. The Administrator similarly denied other claims not raised with reasonable specificity during the public comment period: The comments did not present evidence or analysis to support these petition claims, and thus the state had no opportunity to consider and respond to those claims. Id. at 6, 11, 13, 15. The Luminant Order also included a discussion of the reasonable specificity standard, that absent unusual circumstances, the requirement to raise issues “with reasonable specificity” places the burden on the petitioner to bring forward evidence before the State that would support a finding of noncompliance with the CAA. See id. at 5.

As noted above, the Act contains two enumerated exceptions to the “reasonable specificity” requirement. Namely, issues that were not raised with reasonable specificity during the public comment period can be raised in a petition if the petitioner demonstrates that it was impracticable to raise such objections within such period or unless the grounds for such objection arose after such period. CAA section 505(b)(2). For an issue to fit within one of these exceptions, the petitioner would have to demonstrate the impracticality, or show that the grounds arose after the comment period. The EPA has also addressed this issue in petition orders.

One example is in the 2012 San Juan Generating Station Order, where the EPA responded to a petition claim that the permit failed to assure compliance with PSD applicable requirements because it did not address significant increase of a specific pollutant after a change at the facility. See In the Matter of Public Service Company Of New Mexico, San Juan Generating Station (SJGS), Order on Petition VI-2010 (February 15, 2012) at 10. According to the petitioners, these concerns were not raised during the comment period because the State did not make the information about the significant emission increase available until after the public comment period, when the permitting authority noted in its response to the EPA that the change triggered PSD and expressed its intent to add a title V compliance schedule to the permit. The Administrator found that in this case, the petitioners demonstrated that the grounds arose after the comment period and therefore, the EPA would consider their claim on this matter. See id. at 10.

Petitions may be submitted on several types of proposed title V permits, such as proposed initial permits, permit renewals, or permit revisions, which may include minor or significant modifications to the title V permit. Some stakeholders have indicated there may be confusion on the matter of petition opportunities, particularly for minor modification actions. In cases where the permitting authority has not provided for a prior public comment period on a minor permit modification, petitioners can still submit a petition to the Administrator. 57 FR 32283; see also 40 CFR 70.7(e)(2)(iv) (for a minor modification, the permitting authority may not issue a final permit until after EPA's 45-day review period or until EPA has notified the permitting authority that it will not object, whichever is earlier) and 70.8(e) (a part 70 permit, including a modification, may not be issued until after EPA has had an opportunity to review the proposed permit as required under this section). As the EPA may receive a petition on different types of proposed title V permits, it is important for the agency to be able to identify the particular action of concern to the petitioner.

Under CAA section 505(b)(2), a petition pertains to a particular permit. Thus, the EPA must be able to discern from the petition what permit action the petition is based on in order to review and respond to it. The EPA has interpreted the potential scope of the petition as related to the scope of the permit action that is the basis of the petition. In the 1992 preamble to the final part 70 rule, the EPA explained that public objections to an initial permit, permit revision, or permit renewal must be germane to the applicable requirements implicated by the permitting action in question. For example, objections raised on a portion of an existing permit that would not in any way be affected by a proposed permit revision would not be germane. 57 FR 32250, 32290/3 (July 21, 1992). Consistent with CAA section 505(b)(2), the EPA has considered the scope of the permit proceeding in reviewing petitions and denied petitions that concern issues that are outside the scope of the permit proceeding. See, e.g., In the Matter of Wisconsin Public Service Corporation's JP Pulliam Power Plant (Order in response to Petition Number V-2012-01) (January 7, 2013) at 8; In the Matter of Consolidated Environmental Management, Inc.—Nucor Steel Louisiana, Order on Petition Numbers VI-2010-05, VI-2011-06 and VI-2012-07 (January 30, 2014) (Nucor III Order) at 12.

One such denial can be found in the 2007 Weston Order, in which the EPA received a petition that claimed that the proposed modification permit was deficient because it did not incorporate limits from PSD and preconstruction permit applications for a particular unit at the Weston facility. See, In the Matter of Wisconsin Public Service Corporation—Weston Generating Station (Order in response to Petition) (December 19, 2007). The EPA denied the claim because the unit in question had not been affected by or related to the significant modification on which the title V permitting action was based. The Order stated:

The Weston Order further noted that this limitation on petitions for title V significant modifications did not affect the public's ability to participate in the permit issuance or enforcement processes. When a title V permit is renewed, all aspects of the title V permit are subject to public comment and petition as part of the process to issue a renewal permit. Generally speaking, members of the public can also bring an enforcement action in situations of alleged noncompliance with any permit terms. Furthermore, if the public is concerned that the permit fails to incorporate all applicable requirements, a petition may be submitted to the Administrator to reopen the permit for cause under CAA section 505(e). Id. at 7.

In addition to the threshold requirements, the statute identifies another general guideline for the EPA's consideration. Specifically, to compel an objection by the EPA, CAA section 505(b)(2) requires the petitioner to demonstrate that a permit is not in compliance with requirements of the Act, including the requirements of the applicable implementation plan. The EPA has interpreted the demonstration burden under CAA section 505(b)(2) in numerous title V petition orders and court opinions have also interpreted it. What follows is a brief restatement of interpretations previously articulated in some of those orders and opinions.

In the 2013 Nucor II Order the EPA stated:

The EPA highlighted in the Nucor II Order several reasons why the petitioner's demonstration is important in the context of a title V petition, including first, the relatively short time frames title V of the CAA provides for the EPA to review title V permits and petitions. As previously explained, under CAA section 505(b)(1), the Administrator has only 45 days after receiving a copy of the proposed permit to review that permit and object if she determines that the permit is not in compliance with the CAA. If the Administrator does not object, then any petition for an objection must be filed within 60 days after the expiration of the 45-day review period, and the agency is required to grant or deny that petition within 60 days. See CAA section 505(b)(2). Given these short time frames, the Nucor II Order explained that EPA does not believe it is reasonable to conclude that Congress would have intended for the EPA to engage in extensive fact-finding or investigation to analyze contested petition claims, and in support of this interpretation it cited Citizens Against Ruining the Environment, 535 F.3d at 678, which noted that because the limited time frame Congress gave the EPA for permit review “may not allow the EPA to fully investigate and analyze contested allegations, it is reasonable in this context for the EPA to refrain from extensive fact-finding.” Nucor II Order at 5. Therefore, it is imperative that the petitioner make the demonstration.

After discussing the relatively short time frames for the EPA to review as the first point, the Nucor II Order continued:

In light of the EPA's interpretation of the demonstration requirement and its importance to the implementation of the statutory structure that Congress created for addressing objections to title V permits, the EPA has discussed and applied its interpretation of the demonstration burden in numerous title V orders. Examples of the EPA's application of this standard can be found in: In the Matter of Scherer Steam-Electric Generating Plant Juliette, Georgia, et al., Order on Petition Nos. IV-2012-1, IV-2012-2, IV-2012-3, IV-2012-4, and IV-2012-5 (Apr. 14, 2014) at 12-13; In the Matter of Hu Honua Bioenergy Facility, Order on Petition No. IX-2001-1 (July 2, 2014) (Hu Honua Order) at 25-27; In the Matter of EME Homer City Generation LP, et al., Order on Petition No. III-2012-06, III-2012-07, and III-2013-02 (July 30, 2014) at 24-25; In the Matter of Public Service of New Hampshire Schiller Station, Order on Petition No. VI-2014-04 (July 28, 2015) at 11-12.

The interpretation quoted from the Nucor II Order is based on the discussion of the demonstration burden in opinions from federal courts of appeal. These courts have recognized that the term “demonstrates” in CAA section 505(b)(2) is ambiguous and have accordingly deferred to the EPA's interpretation. See Wildearth Guardians v. EPA, 728 F.3d 1075, 1081-1082 (10th Cir. 2013); MacClarence v. EPA, 596 F.3d 1123, 1130-1131 (9th Cir. 2010); Sierra Club v. Johnson, 541 F.3d 1257, 1265-1267 (11th Cir. 2008); Citizens Against Ruining the Env't v. EPA, 535 F.3d 670, 677-678 (7th Cir. 2008). In so deferring, these courts have discussed the seminal Supreme Court decision, Chevron USA, Inc. v. Natural Res. Def. Council Inc., 467 U.S. 837, 842-843 (1984), which provides guiding principles for judicial review of agency interpretations and determinations under statutes that the agency administers.11 Chevron establishes a well-known two-step test: First, if the Congress has “directly spoken to the precise question at issue” both the court and the agency must “give effect to the unambiguously expressed intent of Congress.” Chevron, 467 U.S. at 842-843. Second, if the statute is ambiguous, courts will generally defer to the agency's interpretation and uphold it so long as it “is based on a permissible construction of the statute.” Id. at 843.

Several federal courts of appeal have agreed with the EPA's position that the term “demonstrates” in CAA section 505(b)(2) is ambiguous. MacClarence, 596 F.3d at 1130 (collecting cases). As one opinion pointed out, “[n]either the Clean Air Act nor its regulations define the term `demonstrates' or give context to how the Administrator should make this judgment.” Sierra Club v. Johnson, 541 F.3d at 1266; see also Citizens Against Ruining the Env't, 535 F.3d at 677-678. After considering the plain meaning of the term “demonstrates” as shown by various dictionary definitions, courts have agreed that the plain meaning “does not resolve important questions that are part and parcel of the Administrator's duty to evaluate the sufficiency of a petition, for example, the type of evidence a petitioner may present and the burden of proof guiding the Administrator's evaluation of when a sufficient demonstration has occurred.” Sierra Club v. Johnson, 541 F.3d at 1266; MacClarence, 596 F.3d at 1131 (same). Similarly, another court observed that the Act “does not set forth any factors the EPA must take into account in determining whether a petitioner has demonstrated noncompliance under [CAA 505(b)(2)].” Wildearth Guardians, 728 F.3d at 1082.

This recognition of the ambiguity in CAA section 505(b)(2) leads to the conclusion that “the statute's silence on these important issues means Congress has delegated to the EPA some discretion in determining whether, in its expert opinion, a petitioner has presented sufficient evidence to prove a permit violates clean air requirements.” Sierra Club v. Johnson, 541 F.3d at 1266. Accordingly, as one opinion put it, “the EPA has discretion under the statute to determine what a petition must show in order to make an adequate `demonstration.' ” Citizens Against Ruining the Env't, 535 F.3d at 678. Similarly, another court explained, “because we conclude [section 505(b)(2)] is ambiguous when it comes to defining the type of demonstration required to trigger the Administrator's duty to object, we are willing to defer to a reasonable interpretation by the agency as to when a petitioner has sufficiently demonstrated noncompliance with PSD requirements.” Sierra Club v. Johnson, 541 F.3d at 1267. In so deferring to the EPA's interpretation of the demonstration standard under CAA section 505(b)(2) some courts have noted that they need not resolve the question of the exact degree of deference to be accorded to the EPA because its “interpretation is persuasive even under [the] less deferential standard of review” under Skidmore v. Swift, 323 U.S. 134 (1944) and “would thus prevail under either standard.” Wildearth Guardians, 728 F.3d at 1082; MacClarence, 596 F.3d at 1131 (same).

In the context of reviewing particular applications of the demonstration burden in title V petition orders, courts have also deferred to the agency's interpretation as to whether or not a petition had adequately demonstrated that an objection was warranted. For example, in MacClarence, the petition was denied in part because it “failed to provide adequate information to support [a claim]” and made “only generalized statements . . . and did not provide adequate references, legal analysis, or evidence in support of these general assertions.” 596 F.3d at 1131 (internal marks omitted). The court found the EPA's construction of the burden under CAA section 505(b)(2) as encompassing an expectation that a petition provide “references, legal analysis, or evidence” a reasonable interpretation, which comported with both the plain meaning of the term “demonstrates” and with CAA section 505(b)(2). Id. In addition, in MacClarence, the petitioner argued that the EPA should not have denied his petition for failing to address the permitting authority's reasoning in the final permitting decision and documents, which differed from the draft documents and explained why the changes had been made. The court upheld the EPA's decision, determining that it was reasonable for the EPA to expect the petitioner to address the permitting authority's final decision. Id. at 1132-33. As another example of the deference that courts have accorded the EPA's application of the demonstration standard, in the Wildearth Guardians case cited above, the court found reasonable the EPA's determination that the petitioner could not rely solely on the fact that a Notice of Violation (NOV) had been previously issued to demonstrate noncompliance. Wildearth Guardians, 728 F.3d at 1082. The court noted that the EPA had explained that an NOV may be a relevant factor in “ `determining whether the overall information presented by Petitioner—in light of all the factors that may be relevant—demonstrates the applicability of a requirement for the purposes of title V' ” but explained that other factors may also be relevant. Id. The EPA further explained that if the petitioner had not addressed other relevant factors, it could find that petitioner “ `failed to present sufficient information to demonstrate that the requirement is applicable.' ” Id. Finding this interpretation of the demonstration requirement persuasive, the court deferred to it. Id.

As noted earlier, many petitions raise numerous and highly complex issues around PSD permitting, a separate permitting program under the CAA. Because of the frequency with which title V petitions raise PSD claims, statements in prior petition orders regarding such claims is worth a separate mention here. In the Meraux Refinery Order, In the Matter of Meraux Refinery, Order on Petition Number VI-2012-04 (May 29, 2015), at 3-4, the EPA stated:

Many petitions also raise issues surrounding emissions monitoring, recordkeeping and reporting in title V permits. Title V of the CAA requires permits to contain adequate emissions monitoring, recordkeeping, and reporting to assure sources' compliance with applicable requirements. 57 FR 32250, 32251 (July 1, 1992). Because of the frequency with which monitoring claims are raised, statements in prior petition orders regarding such claims are also worth a separate mention here. As an example, In the Matter of the Premcor Refining Group, Inc., Order on Petition Number VI-2007-02 (May 28, 2009), at 7, the EPA stated:

The EPA has previously noted that as part of the CAA section 505(b)(2) demonstration requirement, the petitioner is expected to address the permitting authority's final decision, and the permitting authority's final reasoning (including the RTC), where these documents were available during the timeframe for filing the petition. Where a permitting authority has articulated its rationale for the permit terms and conditions concerning an applicable requirement in its record (RTC and statement of basis) and the petitioner did not adequately address that rationale in its petition, the EPA has often denied the petition, at least in part, on that basis. See e.g., In the Matter of Noranda Alumina, LLC, Order on Petition No. VI-2011-04 (December 14, 2012) at 20-21 (denying title V petition issue where petitioners did not respond to state's explanation in response to comments or explain why the state erred or the permit was deficient); In the Matter of Kentucky Syngas, LLC, Order on Petition No. IV-2010-9 (June 22, 2012) at 41 (denying title V petition issue where petitioners did not acknowledge or reply to state's response to comments or provide a particularized rationale for why the state erred or the permit was deficient). Caselaw supports this interpretation. See MacClarence, 596 F.3d at 1132-33 (the Administrator “reasonably expected” the petitioner to challenge the state permitting authority's explanation and reasoning for final permit).

This notice proposes several changes to part 70. Many of the proposed revisions fall within three key areas. First, regulatory language is proposed that encourages the use of the agency's electronic submittal system for title V petitions. Alternative methods for submittal are also identified in this notice. Petitioners who experience technical difficulty when attempting to submit a petition through the electronic submittal system may send it to the designated email address, while those without access to the Internet or unable to access email for other reasons may send a paper copy to the specific physical address identified in this proposal.

Second, this rule proposes mandatory petition content requirements and standard formatting for title V petitions. The EPA has identified key pieces of information that are critical when assessing claims and potential flaws in a title V permit or permit process, and these pieces are now proposed as required content for petitions and would be a new provision, 40 CFR 70.12. Under the proposed revisions, in order to demonstrate a flaw in the permit, permit record, or permit process that warrants an objection under CAA section 505(b)(2), the petition would present the required content in the same manner and order as contained in the new section of the title V regulations, 40 CFR 70.12.

A related change is proposed that would add new regulatory language to 40 CFR 70.8, which would require a petitioner to send a copy of the petition to both the permitting authority and the permit applicant. The current title V regulations do not have provisions effectuating this requirement of section 505(b)(2) of the Act. Therefore, this proposal would insert a requirement into the regulation identical to the one in the Act in order to ensure consistency with this provision of the statute.

Third, the agency proposes to require that permitting authorities respond in writing to significant comments received during the public comment period on a draft title V permit. Further, the EPA proposes regulatory language stating that this response to significant comments, often referred to as the RTC, must be sent with the proposed permit and statement of basis for the 45-day EPA review period of the proposed permit.12 Under the proposed revisions, the EPA 45-day review period would not commence until the proposed permit and all necessary supporting information, including the written RTC, are received. Finally, the EPA proposes to require that within 30 days of sending the proposed permit to the EPA, that permitting authorities must provide notification that the proposed permit and the response to significant public comments are available to the public. Such notice must explain how these materials may be accessed.

These proposed revisions to part 70 provide increased transparency and clarity to the title V petition preparation, submittal, review, and response processes. Improved interactions with stakeholders that participate in the title V process and more accurate tracking of petitions may also result from the establishment of the preferred petition submittal method. If finalized, the proposed rule revisions would help facilitate a more effective process for the development of title V petitions and a more efficient process for the review and response to title V petitions. Overall, the EPA is intending that these rule revisions along with other shared information will help to improve title V permits issued by permitting authorities, promote access to and provide better understanding of the title V petition process for potential petitioners, and reduce delays in decisions and support the agency's efforts to meet its obligations in responding to title V petitions.

For each of the three key areas, the agency describes the proposed regulatory changes, rationale for proposing the changes, and request for comment in the sections that follow. Before discussing each of the three key areas of this proposal, however, this notice provides some additional legal background related to these proposals.

To provide context for the statutory and regulatory interpretations discussed below, the EPA first discusses some additional legal background, including principles generally applied by courts in reviewing agency interpretations.

The Supreme Court decision, Chevron USA, Inc. v. Natural Res. Def. Council Inc., 467 U.S. 837, 842-843 (1984), establishes principles that guide judicial review of agency interpretations of statutes that the agency administers. Under Chevron courts apply a well-known two-step test: First, if the Congress has “directly spoken to the precise question at issue” both the court and the agency must “give effect to the unambiguously expressed intent of Congress.” Chevron, 467 U.S. at 842-843. Second, if the statute is ambiguous, courts will generally defer to the agency's interpretation and uphold it so long as it “is based on a permissible construction of the statute.” Id. at 843. At the second step of this inquiry, also referred to as “Chevron Step 2,” courts such as the D.C. Circuit have frequently explained that “ `Chevron requires that we defer to the agency's reasonable interpretation of the term.' ” Miss. Comm'n on Envtl. Quality v. EPA, 790 F.3d 138, 151 (D.C. Cir. 2015) (quoting Pennsylvania Dept. of Envtl. Protection v. EPA, 429 F.3d 1125, 1130 (D.C. Cir. 2005)). In other words, under Chevron the agency's interpretation “ `governs if it is a reasonable interpretation of the statute—not necessarily the only possible interpretation, nor even the interpretation deemed most reasonable by the courts.' ” Entergy Corp. v. Riverkeeper, Inc., 556 U.S. 208, 218 (2009) (quoted in Airlines for Am. v. Transp. Sec. Admin., 780 F.3d 409, 413 (D.C. Cir. 2015)).

Similarly, courts accord deference to an administrative agency's interpretations of its own regulations under principles enunciated in Auer v. Robbins, 519 U.S. 452, 462-63 (1997). This type of deference is frequently referred to as Auer deference. When an agency's interpretation of a regulation receives Auer deference, the court accepts the agency's interpretation “unless the interpretation is plainly erroneous or inconsistent with the regulations or there is any other reason to suspect that the interpretation does not reflect the agency's fair and considered judgment on the matter in question.” Rural Cellular Ass'n & Universal Serv. v. FCC, 685 F.3d 1083, 1093-1094 (D.C. Cir. 2012) (internal marks and citations omitted).

Finally, the EPA notes that administrative agencies have broad discretion to adopt procedures to discharge their obligations under the statutes they implement. In the words of the U.S. Supreme Court: “[T]he formulation of procedures [is] basically to be left within the discretion of the agencies to which Congress [has] confided the responsibility for substantive judgments.” Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, 435 U.S. 519, 524 (1978). Later in the same case, the Court observed that “[a]bsent constitutional constraints or extremely compelling circumstances the administrative agencies should be free to fashion their own rules of procedure to pursue methods of inquiry capable of permitting them to discharge their multitudinous duties.” Id. at 543-544. Relatedly, courts have emphasized the inherent authority that administrative agencies have “to control the disposition of their caseload” and manage their own dockets. See, e.g., GTE Service Corp. v. FCC, 782 F.2d 263, 273-274 (D.C. Cir. 1986).

In this notice, the EPA is proposing to revise part 70 to add a new provision that would require petitions to be submitted using one of three identified methods. Among those three methods, the agency encourages petitioners to submit title V petitions through the electronic submittal system, the agency's preferred method. The EPA has developed a title V petitions submittal system through the Central Data Exchange (CDX) and information on how to access and use the system is available at the title V petitions Web site: http://www.epa.gov/title-v-operating-permits/title-v-petitions. While the current submittal system was designed using CDX, the EPA recognizes that adjustments to the system or a different submittal system entirely may be needed in the future. Therefore, the title V petitions Web site will provide access to the designated electronic submittal system in use at any given time, which will remain the primary and preferred method for receiving title V petitions. The electronic submittal system allows for a direct route to the appropriate agency staff. It also provides immediate confirmation that the EPA has received the petition and any attachments.

If a petitioner experiences technical difficulties when trying to submit a petition through the electronic submittal system identified on the title V petitions Web site, the petition may also be submitted to the agency through the following email address: [email protected]. This address is being established as an alternative method for use in instances when the electronic submittal system is not available. For petitioners without access to the Internet at the time of petition submittal, this notice also announces the establishment of one specific physical address to which all paper copies of petitions should be sent. Paper copies of all petitions unable to be sent electronically may be sent by mail or by courier to the following address: U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Policy Division, Operating Permits Group Leader, 109 T.W. Alexander Dr. (C504-05), Research Triangle Park, NC 27711. Additional information on these alternative methods for submittal will also be available at the title V petitions Web site.

Although regulatory changes are being proposed to integrate these methods of submission into the part 70 rules, all three of these methods are currently available for petition submission, and petitioners may elect to use any one of them now. Furthermore, although the proposed changes to the regulatory provisions identify three possible means to submit petitions, for any particular petition, once a petition and any attachments have been successfully submitted using one method, there is no need to submit a duplicate copy via another method. The EPA requests that petitioners only submit a petition using one method, which will expedite the administrative process and improve the EPA's efficiency in reviewing petitions. Finally, if these regulatory revisions are finalized, the agency would not be obligated to consider petitions submitted through any means other than the three identified in the rule.

Section 505(b)(2) of the Act requires that the petitioner provide copies of its petition to the permitting authority and the permit applicant. This requirement does not currently appear in the part 70 rules. The EPA is proposing to revise the part 70 regulations in order to fill this gap in the regulations. Specifically, in this notice, the EPA proposes to add language to 40 CFR 70.8(d) that is identical to the statutory language.

In general, feedback from stakeholders, as well as the EPA's experience in receiving petitions, indicate there is confusion at present as to where a petition should be submitted. While section 505(b)(2) of the CAA and 40 CFR 70.8(d) provide that any person may petition the Administrator to object within 60 days after the expiration of the EPA's 45-day review period for the proposed permit, both the statute and the regulations are currently silent as to how a petition should be submitted to the EPA. Because the regulations do not dictate a specific address, title V petitions have been received in a number of different offices within the agency. Most of the recent petitions have been sent to the agency through email, in some cases with a duplicate paper copy sent to a physical address somewhere within the EPA. For example, the agency has received petitions that were sent directly to a staff person in a Regional office, as well as petitions sent directly to the Administrator, either by email or courier. One complication presented by this current practice is that by sending petitions via email, attachments supplied by petitioners as supporting materials may become separated from the petition or lost entirely. In addition, and potentially because of this fact, petition attachments are frequently submitted by mail or courier, while the petition itself is submitted by email. These various submission practices require additional administrative processing within the EPA and can delay the initiation of the substantive petition review process.

One goal of this proposal is to clarify where and how title V petitions should be submitted. Another goal of this proposal is to announce the establishment of an electronic submittal system and promote its use as the preferred method for the submittal of petitions to the EPA. These proposed changes are expected to allow for more accurate tracking of petitions and to increase the agency's efficiency and effectiveness in responding to petitions by ensuring the timely receipt of petitions and any attachments in a central location.

The EPA has identified several benefits of establishing the electronic submittal system as the preferred submittal method for receiving title V petitions. For petitioners, the electronic submittal system will provide immediate confirmation to the petitioner that the petition was received by the agency. In contrast to the size limitations that can be experienced when sending title V petitions through email, petitioners will be able to see that all intended supporting materials are attached to the petition and are submitted in one entry. Thus, submitting a petition and attachments via the electronic submittal system would avoid the need to send multiple emails to transmit the entire petition package. Sending petitions through the electronic submittal system also eliminates timeliness issues from potential mishandling due to courier issues.

For the agency, there is a time savings as petitions and any attachments submitted through the electronic submittal system will be immediately and directly available to the agency. This saves administrative time otherwise spent processing the incoming petition and any attachments, especially those submitted separately from the petition. Thus, the EPA anticipates that using this system will facilitate more efficient processing for incoming petitions. Further, the electronic submittal system in its current form identifies the number of attachments a petitioner intends to submit, which can alert the EPA to any missing attachments.

More information about the electronic submittal system, including information about security concerns regarding providing personal information, uploading and/or downloading files, personally identifiable information (PII), and CBI is available at the CDX Web site: https://cdx.epa.gov/. If this rule is finalized and there is interest from commenters, the EPA will consider developing training webinars on the use of the electronic submittal system.

These proposed rule revisions to identify specific methods for petition submittal fall within the EPA's inherent discretion to formulate procedures to meet its obligations under CAA section 505(b)(2), as discussed in Section IV.A of this notice. In addition, the Act is silent as to the methods that should be used for title V petition submittal but imposes a 60-day deadline for granting or denying such petitions. Accordingly, these proposed changes to improve the efficiency of the EPA's initial processing of petitions and to support the agency's efforts to satisfy that obligation are based on a reasonable interpretation of CAA section 505(b)(2), including the relatively short timeframe for the EPA to grant or deny a petition.

Comments are requested on all aspects of these proposed revisions. The EPA is also specifically soliciting comment on our proposal to add language to part 70 that identifies the electronic submittal of petitions through the agency's identified electronic submittal system as the preferred primary method for submitting a title V petition, as well as identifying two alternative methods that could be used in case of technical difficulties or by a petitioner without Internet access. Commenters are encouraged to address in their comments whether additional specification or direction is needed to ensure all stakeholders are aware and have a better understanding of the preferred electronic submittal process. The EPA is expressly requesting comment on whether the proposed regulatory revisions are necessary, or whether the same effect could be achieved through the direction provided in this preamble and through the title V petitions Web site. Further, the EPA is requesting comment on what, if any, outreach methods or training materials (e.g., written instructions) would assist users with submitting petitions through the CDX system.

The following proposed regulatory changes are designed to assist the public with preparing their petitions, as well as to assist the EPA in its review of petitions. In this notice, the agency proposes to establish in the part 70 regulations key mandatory content requirements for title V petitions. These proposed requirements are based on statutory requirements under CAA section 505(b)(2) and aspects of the demonstration standard interpreted by the EPA in numerous title V petition orders and restated in Section III.D of this notice. By proposing to codify what has already been discussed in prior orders, the EPA aims to help all stakeholders understand the criteria that the EPA applies in reviewing a title V petition. The EPA also proposes to establish requirements to encourage similar formats for all petitions to further assist the agency in its review process.

The EPA is proposing to revise part 70 to require standard content that must be included in a title V petition, laying out the agency's expectations with more specificity to assist petitioners in understanding how to make their petitions complete and to enhance the EPA's ability to review and respond to them promptly. Under this proposal, a new section of the title V regulations, 40 CFR 70.12, would add the following list of required elements:

• Identification of the proposed permit on which the petition is based. The proposed permit is the version of the permit the permitting authority forwards to the EPA for the agency's 45-day review under CAA section 505(b)(1).13 A petition would be required to provide the permit number, version number, and/or any other information by which the permit can be readily identified. In addition, the petition must specify whether the relevant permit action is an initial issuance, renewal, or modification/revision, including minor modifications/revisions.

• Sufficient information to show that the petition was timely filed. A petition must be filed within 60 days after the expiration of the Administrator's 45-day review period, as required by section 505(b)(2) of the Act. Timeliness may be demonstrated by the electronic receipt date generated upon submittal of the petition through the agency's electronic submittal system, the date and time the emailed petition was received, or the postmark date generated for a paper copy mailed to the agency's designated physical address. It is helpful if the petition provides key dates, such as the end of the public comment period provided under 40 CFR 70.7(h), (or parallel regulations in an EPA-approved state, local or tribal title V permitting program), or the conclusion of the EPA 45-day review period for the proposed permit.

• Identification of Petition Claims. Any issue raised in the petition as grounds for an objection must be based on a claim that the permit, permit record, or permit process is not in compliance with the applicable requirements under the Act or requirements under part 70. All pertinent information in support of each issue raised as a petition claim must be included within the body of the petition. In determining whether to object, the Administrator would not consider information incorporated into the petition by reference (for example, comments offered during the public comment period on the draft permit that are incorporated by reference into the petition on the proposed permit, or, as another example, claims raised in one title V petition that are incorporated by reference into a different title V petition). However, petitions may and should still provide citations to support each petition claim (e.g., citations to caselaw, statutory and regulatory provisions, or portions of the permit record). For each claim raised, the petition would need to identify the following:

○ The specific grounds for an objection, citing to a specific permit term or condition where applicable.

○ The applicable requirement under the CAA or requirement under part 70 that is not met. Note that the term “applicable requirement” refers to Clean Air Act requirements only, and does not include other requirements (e.g., Endangered Species Act, Clean Water Act) to which a source may be subject. The term “applicable requirement” of the CAA for title V purposes is defined in 40 CFR 70.2.

○ An explanation of how the term or condition in the proposed permit, or relevant portion of the permit record or permit process, is not adequate to comply with the corresponding applicable requirement under the CAA or requirement under part 70.

○ If the petition claims that the permitting authority did not provide for the public participation procedures required under 40 CFR 70.7(h), the petition must identify specifically the required public participation procedure that was not provided.

○ Identification of where the issue in the claim was raised with reasonable specificity during the public comment period provided for in 40 CFR 70.7(h), citing to any relevant page numbers in the public comment as submitted and attaching the submitted public comment to the petition. If the grounds for the objection were not raised during the public comment period, the petitioner must demonstrate that it was impracticable to raise such objections within the period or that they arose after such a period, as required by section 505(b)(2) of the Act and 40 CFR 70.8(d).

○ Unless the exception under CAA section 505(b)(2) and 40 CFR 70.8(d) discussed in the immediately preceding bullet applies, the petition must identify where the permitting authority responded to the public comment, including the specific page number(s) in the document where the response appears, and explain how the permitting authority's response to the comment is inadequate to address the claimed deficiency. If the written RTC does not address the public comment at all or if there is no RTC, the petition should state that.

In addition to including all specified content, it is important that the information provided or any analysis completed by the petitioner must also be accurate. However, including this content would not necessarily result in the Administrator granting an objection on any particular claim raised in a petition. For example, a petitioner could include all this information but not demonstrate noncompliance, or the petition might point to a specific permit term as not being adequate to comply with an air emission limit, but may not have identified the appropriate applicable requirement.

One impediment to the EPA's review process is the use of incorporation by reference of other documents, in whole or in part, into petitions. As noted earlier in this section, under “identification of petition issues” in the new proposed mandatory content requirements, the EPA would require all pertinent information in support of each issue raised as a petition claim to be included in the body of a petition. Incorporating information into a petition by reference is inconsistent with the demonstration obligations in the statute and would extend the petition review time as the agency spends time searching for and then attempting to decipher the petitioner's intended claim. In practice, the EPA often finds that where claims have been incorporated by reference it is not clear that the specific grounds for objection have been raised by the petitioner, which could lead to the EPA denying for failure to meet the demonstration burden. Relatedly, petitioners have sometimes used incorporation by reference to include comments from a comment letter, but a comment letter alone would typically not address a state's response to the comment. See, e.g. Nucor III Order at 16 (noting that the “mere incorporation by reference . . . without any attempt to explain how these comments relate to an argument in the petition and without confronting [the State's] reasoning supporting the final permit is not sufficient to satisfy the petitioner's demonstration burden”). In practice, the EPA has found that the incorporation of comments by reference into a petition can lead to confusion concerning the rationale for the petitioner's arguments, as it is frequently unclear which part of the comment is incorporated, how it relates to the particular argument in the petition, and the precise intent of the incorporation. In addition, the incorporation of comments by reference increases the agency's review time, as the EPA must review more than one document to try to determine the complete argument that a petitioner is making. Therefore, the EPA is proposing to revise the regulations to state that the Administrator will not consider information incorporated by reference into a petition. However, a petition should still provide citations as needed to support its legal and factual assertions.

For further transparency and clarity, the EPA in this notice gives examples of types of information that are not necessary to include when preparing an effective petition. In doing so, the EPA hopes to ease the effort associated with preparing a petition while promoting succinctness. For example, while a petitioner needs to cite to the legal authority supporting its specific claim, a petition does not need to include pages of background or history on aspects of the CAA. If a petitioner wishes to include additional information for an alternate purpose unrelated to the EPA's review of the specific petition claim, the EPA recommends appending this information to the petition as a separate document and identifying the purpose for which it is provided.

Even with all necessary information provided, a petition may still require substantial time to review because of how it is organized. Therefore, the EPA is also proposing and taking comment on format requirements. If information is presented in the same format, including the same order, in all petitions, the EPA anticipates this standard organization could reduce review time as the general location of specific details would be the same in every petition received. These proposed format requirements could also help petitioners better understand what is, and what isn't, necessary in an effective title V petition. To that end, the EPA proposes the use of a standard format following the same order as previously identified in the list of required petition content. Regulatory language to this effect is included in the proposed new provision, 40 CFR 70.12. If finalized, templates and/or guidance are planned for development for inclusion on the title V petitions Web site.

Further, the EPA is requesting input from the public on several specific questions related to potentially establishing page limits for title V petitions, as explained further in Section IV.C.4 of this notice. While the EPA has received petitions ranging from approximately 3 to 82 pages (excluding attachments), the length for most petitions is in the range of 20 to 30. The amount of detail required to successfully raise a claim and meet the demonstration standard may depend on the complexity of the issue. However, we expect that most claims could be written effectively and succinctly, as demonstrated in the example claim that follows.

The following paragraphs contain an example of a concise and effective presentation of a hypothetical single claim that would be part of a larger petition—one that includes all pieces of required content for a claim proposed in this rule. Because this is only a sample claim, not a sample petition, it does not include some of the required content that relates to the petition as a whole (such as identifying information for the proposed permit). This example is organized following the order presented in the proposed required content changes identified previously, which is also the proposed standard format. The bullets highlight each element of the proposed content requirements.

Although EPA is providing this sample claim to illustrate how the material that would be required under the proposed regulatory revisions could be presented succinctly and effectively, the information that is needed to satisfy the demonstration burden for any given petition claim will vary depending on the specifics of the claim, the applicable requirements, and the underlying permit terms and record. The following hypothetical claim is provided solely for purposes of illustration:

Facility X's title V permit lacks monitoring sufficient to assure compliance with the 4.5 pound per hour (lb/hr) nitrogen dioxide (NOX) emission limitation of the approved State Implementation Plan (SIP) at 30 State Administrative Code 66.54.2. Specifically, Permit Condition I.D.26 requires that NOX emissions from Facility X's combustion units (Units 1-6 and 11-14) cannot exceed 4.5 pounds of NOX per hour. Permit Condition II.D.105 requires once-per-year portable analyzer monitoring for Units 1-6 and 11-14. The permit contains no other testing, monitoring, recordkeeping, or reporting requirements on these units, and contains no other monitoring that could be used determine compliance with the 4.5 lb/hr NOX emission limit for the units.

CAA section 504(c), and the implementing regulations in 40 CFR 70.6(c)(1) and 70.6(a)(3)(i)(B), requires all title V permits to contain monitoring requirements to assure compliance with permit terms and conditions. See also 30 State Administrative Code 66.55.5(b) and (c) (same requirements in state's approved title V program). The permit does not meet this requirement as explained in the following analysis.

The SIP-approved NOX limitation does not include any periodic monitoring requirements, so 40 CFR 70.6(a)(3)(i)(B) requires state agency to add periodic monitoring sufficient to yield reliable data from the relevant time period that are representative of the source's compliance with the permit. The monitoring added by the state in Permit Condition II.D.105 fails to satisfy that requirement under part 70 because monitoring only once annually for the engines units is inadequate to assure compliance with an hourly emission limit.

This petition does not claim that any public participation procedures were not provided.

Public Group Y (Petitioners) raised this issue on page 5 of the July 31, 2015 comment letter it submitted on Facility X's July 1, 2015 draft title V permit. (See Public Group Y Comments at 5; Petition Exhibit A at 5.)

In responding to Petitioners' comment stating that the frequency of the permit's compliance monitoring for the compressor engines' 4.5 lb/hour NOX limit was inadequate to assure compliance with the permit term, state agency asserted that “all that the title V provisions in 30 State Administrative Code 66.55.5(b) and the parallel requirements in 40 CFR 70.6(a)(3)(i)(B) require is periodic monitoring sufficient to yield reliable data that are representative of the source's compliance with the permit. Continuous monitoring is not required.” [RTC) at 8; Petition Exhibit B at 8]. The RTC states that state agency's monitoring protocol for this unit type requires “quarterly portable analyzer testing on units with catalytic converters and annual testing on units without controls.” Id. The RTC then concludes that “[b]ecause the portable analyzer test is a short term test, it demonstrates compliance with the emission limits for that time period. Due to the steady state operation of these units, state agency believes that the portable analyzer testing along with proper operation and maintenance of the units provides reasonable demonstration of compliance with hourly NOX and CO emission limits.” Id. Although state agency asserts that it included NOX monitoring in accordance with its monitoring protocols for engines, state agency's RTC does not adequately explain how the monitoring in Facility X's permit is sufficient to assure compliance with the hourly NOX limit in Permit Condition I.D.26.

As explained, state agency is relying on the portable analyzer test results as a snapshot sampling of emissions to confirm annually whether the units continue to meet their 4.5 lb/hour NOX limits. Between annual portable analyzer tests, state agency relies on assumptions of steady state operation and “proper operation and maintenance of the units” to provide a “reasonable” demonstration of compliance with hourly NOX emission limits. The RTC, however, does not identify any permit terms or conditions that require proper operation and maintenance of the units; nor does it provide an explanation (or appropriate citation to the technical discussion) of why it believes its assumptions about steady-state operations are reasonable for this equipment, or explain how such assumptions, in conjunction with an annual emissions test, constitute monitoring that demonstrates compliance with a short term limit. Accordingly, the EPA must grants the petition on this claim.

The CAA and part 70 regulations currently provide little information on what a title V petition must or should contain. In fact, the primary requirement in CAA section 505(b)(2) is that a petition (with a few identified exceptions) must be based on objections that were raised with reasonable specificity during the public comment period for the permit, and that is the only specific requirement for petition content in the relevant regulation. See CAA section 505(b)(2) and 40 CFR 70.8(d). As a result, the content and format of petitions have varied widely. In the agency's experience, many petitions fail to include key pieces of information, making it more time-consuming and resource-intensive for the EPA to assess the claim. Many petitions are also convoluted, include extraneous or irrelevant information, or fail to present the key information in a logical progression, making it difficult for the agency to ascertain the specific issue being raised. Contributing to the confusion, petitions frequently include large sections of text that appear to have been developed for other reasons and are not relevant to raising or evaluating a claim about a specific flaw in the title V permit or permitting process.

One of the EPA's desired outcomes for this proposed rule is to provide direction to petitioners that will assist them with preparing petitions. The agency anticipates receiving petitions that are both more concise and clear and that contain all the key relevant material, so that the EPA does not have to search for fundamental information or attempt to decipher the petitioner's intent. These proposed revisions are intended to facilitate a more effective petition development process and a more efficient petition review and response process, which are critical in this context because CAA section 505(b)(2) requires the agency to grant or deny a petition within 60 days. Similarly, this tight timeframe makes it imperative that a petitioner make a clear and concise demonstration that can be efficiently evaluated. By proposing to create obligations related to the content and structure of a petition, the EPA anticipates receiving petitions that more clearly articulate the petition claim and the basis for it, focusing on key information, including the alleged deficiency in the permit or permit process; the applicable requirements under the CAA or requirements under part 70 that are in question; and where the issue was raised during the public comment period (or a demonstration as to why it was impracticable to do so or that the grounds for the objection arose after the public comment period closed), how the state responded, and why that response did not adequately address the issue.

These proposed rules are consistent with statements and conclusions that the EPA has made in previous orders responding to title V petitions. The EPA has identified and emphasized the importance of such key pieces of information in assessing petitioners' claims that a title V permit or permit process does not assure compliance with applicable requirements under the CAA or under part 70. For context, examples of some of these orders were discussed in Section III.D of this notice. The EPA is proposing to add petition content requirements that would make certain information mandatory in petitions. These requirements would help clarify for petitioners specific information that is useful or necessary to evaluate a petition claim. The EPA anticipates that these mandatory petition content requirements and standard formatting would help petitioners to succinctly focus their claims and present them effectively. The EPA anticipates that these proposed changes could also decrease the instances in which the Administrator denies a petition because the petitioner did not provide an adequate demonstration. The agency believes these changes would help petitioners to hone their claims to include the appropriate information and to realize when a claim does not meet the mandatory requirements and should not be included in the petition (e.g., the state adequately addressed the issue in its RTC).

The EPA expects the proposed revisions to require mandatory content to improve the efficiency of the agency's review process for title V petitions, as the key information would be presented in a clear and succinct fashion. Similarly, the agency expects that the proposed revisions to require similar organization for all petitions could reduce agency review time as a result of having the specific information in the same format in every petition received. Increasing the efficiency of the review process, and more specifically reducing the time it takes to review petitions, are consistent with Congress's intent that the petition process proceed in a timely and expeditious fashion, as indicated by the 60-day time frame for the Administrator to grant or deny petitions provided in CAA section 505(b)(2). See Citizens Against Ruining the Environment, 535 F.3d at 678 (noting that because the limited time frame Congress gave the EPA for permit review “may not allow the EPA to fully investigate and analyze contested allegations, it is reasonable in this context for the EPA to refrain from extensive fact-finding”).

Moreover, as discussed in more detail in Section III.D of this notice, the EPA has explained in previous title V orders the importance of the demonstration burden in determining whether or not to grant an objection in response to a petition. See, e.g., Nucor II Order at 4-7. The Act does not dictate all the information that must be included or the format in which that information should be presented; nor does it address what kind of showing must be made in order to demonstrate that an objection is warranted. Courts have determined that the term “demonstrates” in CAA section 505(b)(2) is ambiguous and have accordingly deferred to the EPA's reasonable interpretation of that term. See, e.g., MacClarence, 596 F.3d at 1131 (finding the EPA's expectation that a petition provide “references, legal analysis, or evidence” a reasonable interpretation of the term “demonstrates” under CAA section 505(b)(2)). The proposed changes are aimed in part at helping petitioners ensure that they are including information in their petitions that is necessary to satisfy the demonstration burden, under the EPA's interpretation.

Furthermore, these proposed revisions to the part 70 rules related to mandatory petition content and format fall within the EPA's inherent discretion to formulate procedures to discharge its obligations under CAA section 505(b)(2), as discussed in Section IV.A of this notice. Similar procedural requirements have been established for other EPA programs and processes, including the procedures for appeals filed with the Environmental Appeals Board (EAB). See 78 FR 5281 (2013) (adopting revisions to “codify current procedural practices, clarify existing review procedures, and simplify the permit review process”).

Comments are requested on all aspects of these proposed revisions. The EPA is proposing changes to part 70 to include mandatory petition content and format to facilitate the efficient review of issues raised in petitions. The EPA requests comment on all aspects of the required petition content in the proposed 40 CFR 70.12, including the requirement to provide all key information, arguments, or analysis in the petition, rather than incorporating it by reference. The agency also requests comments on the proposed requirement that the petition format follow the same order as the proposed list of required content, as well as the proposed revision to the regulatory language in 40 CFR 70.8(d) that requires that copies of the petition be provided to the permitting authority and the applicant.

The EPA is also requesting comment on whether or not page limits should be established for title V petitions, as a means of promoting concise petitions and to further facilitate efficient and expeditious review of petitions by the EPA. Procedural requirements specifying the maximum length of submissions have been instituted for processes such as the EAB appeal process, where petitions and response briefs may not exceed an identified word or page limit. See 40 CFR 12419(d)(3) (limiting petitions and response briefs to either 14,000 words or alternatively, a 30-page limit). Based on the EPA's assessment of petitions received to date, most claims could be written effectively and succinctly in one or two pages. However, we recognize that some claims are more complex and could benefit from more space for an effective demonstration. If page limits were established in the final rules, petitioners would need to include the mandatory required content (if finalized) while adhering to a specified page limit. We also request comments on the following questions: if a page limit is established, what would be an adequate number of pages, excluding attachments, for a complete but concise petition? Would a page limit in the range of 15-20 or 20-30 pages be reasonable excluding attachments? What would be an adequate number of pages for a complete but concise claim? When responding to these questions, the EPA requests that commenters provide a rationale or basis for their responses.

The EPA proposes to revise 40 CFR 70.7 to require a permitting authority to respond in writing to significant comments received during the public participation process for a draft permit. The agency is proposing a regulatory revision to 40 CFR 70.8 that would require a written response to all significant comments (RTC) and the statement of basis document to be included as part of the proposed permit record that is sent to the EPA for its review under CAA section 505(b)(1).14 Finally, the EPA proposes to revise 40 CFR 70.4(b), 70.7(h), and 70.8(a) to specifically identify the statement of basis document as a necessary part of the permit record throughout the permitting process. If no significant comments are received during the public comment period, the permitting authority should prepare and submit to EPA for its 45-day review a statement to that effect.

Under the existing 40 CFR 70.7(h)(5), a permitting authority is required to keep a record of the commenters and also of the issues raised during the public participation process so that the Administrator may fulfill the obligation under CAA section 505(b)(2) of the Act to determine whether a title V petition may be granted. This provision also requires that such records shall be available to the public. The EPA is proposing regulatory language to revise 40 CFR 70.7 to add a new requirement that a permitting authority respond in writing to significant comments from the public participation process for a draft title V permit.15 Significant comments in this context include, but are not limited to, comments that concern whether the title V permit includes terms and conditions addressing federal applicable requirements, including monitoring and related recordkeeping and reporting requirements. If no significant comments are received during the public comment period the permitting authority should prepare a statement to that effect.

The statement of basis document, which provides the legal and factual basis for the permit terms or conditions, is a necessary component for an effective permit review. Under the current regulations, permitting authorities are required to send this “statement of basis” to the EPA and “to any other person who requests it.” 40 CFR 70.7(a)(5). The EPA recently compiled best practices for developing and preparing statement of basis documents in the April 2014 guidance document, Implementation Guidance on Statement of Basis Requirements Under the Clean Air Act Title V Operating Permits Program. 16 In most situations, the permitting authority makes the statement of basis document available for the public comment period on the draft permit (at least 30 days long), for the EPA's 45-day review, and during the 60-day petition period.

To address any occasions where it may be absent during the permit issuance process, the EPA now proposes to add language to the part 70 regulations that would reaffirm its importance and require its inclusion at all points in the permit review process for every permit. To that end, we are proposing that 40 CFR 70.4(b), 70.7(h) and 70.8(a) would be revised to specifically identify the statement of basis document as a required document.

The EPA proposes one additional change to 40 CFR 70.4(b) to amend an incorrect reference. Specifically, the language in 40 CFR 70.4(b)(3)(viii) currently reads: “[t]he contents of a part 70 permit shall not be entitled to protection under section 115(c) of the Act.” However, section 115(c) of the Act pertains to reciprocity related to statutory provisions addressing endangerment of public health or welfare in foreign countries from air pollution emitted in the United States.

Therefore, the EPA proposes to revise the citation in 40 CFR 70.4(b)(3)(viii) to section 114(c) of the Act, which pertains to the availability of records, reports, and information to the public. This change ensures the regulations comport with the parallel provision in the section 503(e) of the CAA, which states that: “The contents of a permit shall not be entitled to protection under section 7414(c) of this title.”

The agency considers both the statement of basis and the written RTC to be integral components of the permit record. Having access to these documents during the agency's 45-day review period could improve the efficiency of the review, and also ensures that the agency has these critical parts of the record before it in reviewing a proposed permit under CAA section 505(b)(1). Further, it ensures that these documents are completed and available during the petition period under CAA section 505(b)(2). The EPA is proposing revisions to part 70 to require that any proposed permit that is transmitted to the agency must include both the statement of basis and written RTC among the necessary information as described in 40 CFR 70.8. The agency is proposing that the 45-day review period would not begin until all the supporting information listed in the proposed revisions to 40 CFR 70.8(a)(1)(i) has been received by the EPA. This includes the proposed permit, statement of basis, and the written RTC (or when no significant comments are received during the public comment period a statement to that effect). Finally, the EPA proposes to revise 40 CFR 70.7(h)(7) to require that within 30 days of sending the proposed permit to the EPA, that permitting authorities must provide notification that the proposed permit and the response to significant public comments are available to the public. Such notice must explain how these materials may be accessed.

The EPA recognizes that some permitting authorities run the 30-day public comment period and 45-day EPA review period concurrently, as long as no significant comments are received. Under this proposal such a practice could continue, but if a significant public comment is received, the Administrator would no longer consider the submitted permit as a proposed permit. In such instances, the permitting authority must make any necessary revisions to the permit or permit record, and per the regulations proposed in this notice, resubmit the proposed permit to EPA with the RTC and statement of basis, and any other required supporting information, with any revisions that were made to address the public comments, to re-start the EPA's 45-day review period. This reflects the EPA's understanding of how such concurrent permitting programs currently operate.

Because the petition period runs from the end of the EPA's 45-day review period, and the date a proposed permit is received by the EPA is not always apparent, the petition deadline is not always readily apparent. To date, the agency has encouraged permitting authorities to provide notifications to the public or interested stakeholders regarding the timing of proposal of permits to the EPA, for example by making that information available either online or in the publication in which public notice of the draft permit was given. At this time, the agency is considering and requests comment on the best method for the public to be made aware of the date that a proposed permit is received by the EPA, as well as the deadline to submit a petition on a particular proposed permit. The EPA proposes to post when a proposed permit is received and the corresponding 60-day deadline for submitting a petition on the EPA Regional Office Web sites.

Section 505(a)(1)(B) of the CAA requires in relevant part that permitting authorities transmit to the Administrator each proposed permit. The current regulations contain the same requirement in 40 CFR 70.8(a)(1). Failure to submit any information necessary for the adequate review of the proposed permit is grounds for an objection. See 40 CFR 70.8(c)(3)(ii). Part 70 also currently requires that the permitting authority provide a statement of basis that sets forth the legal and factual basis for the draft permit conditions (including references to the applicable statutory and regulatory provisions). See 40 CFR 70.7(a)(5).

As a general matter, initial and renewed title V permits are developed by a permitting authority and then go through a public notice and comment period. The draft permit may undergo some revisions based on the public comment period and this updated version of the permit, referred to as the proposed permit, is sent to the EPA for a 45-day review period per CAA section 505(b)(1). Many permitting authorities already send a written RTC and a statement of basis along with the proposed permit for the EPA 45-day review. However, there are other permitting authorities that do not; instead this information may be provided by these permitting authorities at some point later in the permitting process. When these documents, and the RTC document in particular, are unavailable for the EPA review period, the EPA cannot provide a fully effective review. Moreover, when these documents are unavailable to the public following the EPA's review, potential petitioners may be missing necessary information to determine whether to submit a petition or to provide a full argument in support of any issues they may raise in a petition.

Notably, the EPA's 45-day review period under the current rules begins when the EPA has received the proposed permit and “all necessary information” from the permitting authority. 40 CFR 70.8(c). With regard to the availability of necessary information for the agency's 45-day review of a proposed permit, the EPA stated in the proposal to the original title V regulations that the agency believes it can object to the issuance of permit where the materials submitted by the permitting authority do not provide enough information to allow a meaningful EPA review of whether the proposed permit is in compliance with requirements of the Act (including the SIP). If the agency was not able to object under these circumstances, the EPA's oversight rule could be severely hampered. 56 FR 21750 (1991). The EPA continues to interpret the Act in this way and provides part of the rationale for these proposed revisions to the regulations.

In reviewing title V petitions, the EPA generally pays careful attention to the permitting authority's RTC. The EPA also explained the benefits of making the written RTC available during its 45-day review period in 2014 in the Hu Honua Order:

See, In the Matter of Hu Honua Bioenergy Facility, Order on Petition No. IX-2001-1 (July 2, 2014) at 30.

As noted in Section III.D.5 of this notice under general principles of administrative law, it is incumbent upon an administrative agency to respond to significant comments raised during the public comment period. See, e.g., Home Box Office v. FCC, 567 F.2d 9, 35 (D.C. Cir. 1977) (“the opportunity to comment is meaningless unless the agency responds to significant points raised by the public.”) It is to the benefit of the permitting authority to respond to significant comments, as it is an opportunity to further refine the permit record and/or articulate the authority's rationale. As the issues raised in a title V petition must generally be raised with reasonable specificity during the comment period, responding to comments gives the permitting authority a chance to address any issues that may become the basis for a petition. Generally speaking, in order to make the demonstration required under CAA 505(b)(2), a petitioner is expected to address the permitting authority's final decision and reasoning, including any response in the RTC. See MacClarence, 596 F.3d at 1132-33; see also, e.g., In the Matter of Noranda Alumina, LLC, Order on Petition No. VI-2011-04 (December 14, 2012) at 20-21 (denying title V petition issue where petitioners did not respond to state's explanation in response to comments or explain why the state erred or the permit was deficient); In the Matter of Kentucky Syngas, LLC, Order on Petition No. IV-2010-9 (June 22, 2012) at 41 (denying title V petition issue where petitioners did not acknowledge or reply to state's response to comments or provide a particularized rationale for why the state erred or the permit was deficient). However, if the state has not responded to the comment, there is nothing for the petitioner to address. If the written RTC is not available during the petition period, it may not be clear how the petitioner would be able to address the permitting authority's response in its petition. Similarly, if a permitting authority has not adequately articulated its rationale for a particular permitting action that rationale may not be evident to the EPA from the permit record and a petitioner may be able to easily demonstrate that the articulated rationale is inadequate to support the action. For these reasons, without the availability of the written RTC during the petition period, there may be an increased likelihood of granting a particular claim on the basis that the state provided an inadequate rationale or permit record.

While many permitting authorities submit the RTC and statement of basis with a title V proposed permit, these proposed revisions, if finalized, would promote national consistency and the availability of the RTC document during the EPA 45-day review and the 60-day window in which a petition may be submitted on the proposed permit. This proposed requirement would allow a petitioner to better determine whether flaws in the permit, permit record, or public participation procedures raised during the public comment period had been adequately addressed. In turn, this would enhance a petitioner's confidence in its judgment whether a title V petition is warranted, because it would have the benefit of the permitting authority's rationale for permit terms and permit actions. Thus, it could facilitate resolution of issues earlier in the permitting process and may reduce the number of petitions or petition claims filed. Further, when properly implemented by permitting authorities, the agency anticipates that this proposed requirement would likely reduce the number of EPA determinations to grant a petition because a permitting authority's rationale is inadequate. The EPA is proposing this regulatory change to ensure that petitioners have the opportunity to address the permitting authority's response to comment in order to meet their demonstration burden. As such, these proposed revisions are supported by and would help implement the EPA's interpretation in this context of the ambiguous term “demonstrate” under CAA section 505(b)(2). See MacClarence, 596 F.3d at 1132-33 (finding the EPA's expectation that a petitioner challenge a permitting authority's final reasoning as reflected in the statement of basis of the permit a reasonable interpretation of the demonstration requirement).

These proposed changes are responsive to recommendations from the CAAAC Title V Task Force Final Report. The 2006 report included a number of recommendations for implementation improvements, including specific recommendations regarding public notification and public participation in the title V process. The majority of Task Force members agreed that if a permitting authority receives comments on a draft permit, it is essential that the permitting authority prepare a written response to comments. See Title V Task Force Final Report Recommendation 1 at page 238. The majority of Task Force members also recommended that if a permitting authority received public comments (from anyone other than the permittee) during the public comment period, the RTC described in Recommendation 1 should be provided to the EPA for consideration during its 45-day review period. See Title V Task Force Final Report Recommendation 2 at 239.

While the Act does not expressly require the submission of the RTC and statement of basis together with the proposed permit, it also does not preclude such a requirement or prescribe the specific materials that are needed to review a proposed permit. In light of the focus of CAA section 505(b)(2) on issues raised with reasonable specificity during the comment period, it is reasonable to interpret the Act to include a requirement that would allow the EPA and the public access to materials such as the RTC and statement of basis that would allow them to evaluate the issues raised with reasonable specificity during the comment period and the permitting authority's response.

The agency believes these proposed revisions to the part 70 rules are within the EPA's inherent discretion to formulate procedures to discharge its obligations under CAA sections 505(b)(1) and 505(b)(2), as discussed in Section IV.A of this notice. If finalized, it would help the EPA more efficiently review both proposed permits and title V petitions.

Comments are requested on all aspects of these proposed revisions. Comments are specifically requested on the proposed regulatory language requiring the preparation of a written RTC. Additionally, the EPA requests comment on all aspects of the proposal to require both the written RTC and statement of basis be included in the record that is sent with the proposed title V permit for the EPA's 45-day review. The EPA is expressly taking comment on the best method(s) for proposed permits to be made available so that the public is aware when a proposed permit is received by the EPA for its 45-day review. States are also encouraged to provide information on whether any changes to state rules and programs would be necessary if this proposed revision to part 70 were finalized. The EPA is also expressly taking comment on the practices of permitting authorities that conduct concurrent review and is particularly interested in what processes or steps should be followed to allow for concurrent review, even if the permitting authority is not aware of whether or not it will receive comment on the title V permit when that permit is initially submitted to EPA. Finally, the EPA solicits comments on the proposed regulatory language in 40 CFR 70.4, 70.7, and 70.8 requiring the statement of basis is necessary or appropriate to ensure the document is available at all stages of the permit issuance process, or whether including it in fewer provisions would be adequate (and if so, which ones).

In this section of the notice, the EPA is providing information on certain steps in the title V petition process, namely the permit issuance process that occurs before a petition is submitted, and the post-petition process, which occurs after the EPA grants an objection on at least one issue in a petition. The EPA anticipates this information will help stakeholders gain a better understanding of the role a petition might play in the development of a permit that assures compliance with applicable requirements under the CAA and part 70. Most of what follows has been addressed publicly in various formats, but the EPA believes that repeating this information here for the public's convenience will provide stakeholders with a comprehensive look at the petition opportunity in CAA section 505(b)(2) and 40 CFR 70.

The proposed changes in Section IV.D of this notice are intended to increase the effectiveness of the EPA 45-day review as well as ensure that the full permit record is before petitioners during the 60-day petition period. Making these documents available also provides an opportunity for a permitting authority to ensure that they have fully responded to comments when preparing the proposed permit. Permitting authorities have at least three opportunities to provide the permit record and ensure that it comports with the CAA: the draft, proposed, and final permit.

While the EPA is not requiring the following actions, the agency is recommending practices for permitting authorities when preparing title V permits. In the agency's experience, these practices can minimize the likelihood that a petition will be submitted on a title V permit. Many involve taking action at an appropriate time to ensure that the permit includes the conditions to assure compliance with applicable requirements under the CAA and part 70. In addition, many focus on consulting with the appropriate EPA Regional Office early when preparing and issuing permits. These “recommended practices” include:

○ Consulting with the appropriate EPA Regional Office as needed on key aspects of the permit before the draft permit stage, especially if the permit is expected to be highly visible or contested.

○ On a case-by-case basis, considering whether a particular draft permit warrants outreach to the community.

○ On a case-by-case basis, considering whether it is appropriate to provide for a public participation opportunity on a revised draft permit.

○ Fully addressing significant comments on draft permits and ensuring the permit or permit record includes adequate rationale for the decisions made. For example, permitting authorities should provide sufficient rationale for selected monitoring to assure compliance. The EPA's objections based on an inadequate record most often occur when the EPA finds that a permitting authority did not sufficiently explain why the monitoring was sufficient to assure compliance with a particular limit.

○ Consulting with the appropriate EPA Regional Office as needed to resolve issues related to comments on draft permits and incorporating those resolutions into the proposed permits.

○ Consulting with the appropriate EPA Regional Offices as needed to resolve issues related to the EPA objections or comments on proposed permits and incorporating those resolutions into the final permits.

○ For petitions on which the EPA grants an objection on a claim because the record is inadequate, revising the record and permit as necessary and in a timely manner to resolve the objection.

○ Reviewing permits that are the subject of a petition and revising or reopening for cause to address any issues raised by the petition that have not been resolved.

○ Posting the proposed permit and RTC online where possible.

The EPA is providing the following recommended practices for a source to consider to help ensure that its permit includes the conditions to assure compliance with applicable requirements under the CAA and part 70. In some cases, this may minimize the likelihood that a petition will be submitted on its title V permit. These “recommended practices” include:

○ Submitting permit applications that include all information required under the approved title V permit program.

○ Consulting with the permitting authority when any discrepancy or inaccuracy is identified in the permit, at any stage of the permitting process.

○ Promptly providing any updates to the permit application to the permitting authority.

○ If public comments identify an issue in the draft permit, contacting the permitting authority to make revisions to address the concern before the permit is proposed to the EPA.

○ Timely responding to inquiries from the permitting authority at each stage in the permitting process, including the draft, proposed, and final stages.

The following discussion provides information about the activities that occur, or may occur, after the EPA responds to a title V petition. Various stakeholders have indicated there can be confusion around the appropriate steps following an EPA petition order, particularly when the Administrator granted the petition in whole or in part. The summary below describes EPA's interpretation of key provisions of the CAA and implementing regulations. This interpretation has already been shared publicly in title V orders responding to petitions. See, e.g., In the Matter of Public Service of New Hampshire Schiller Station, Order on Petition Number VI-2014-04 (July 28, 2015) at 4; In the Matter of Meraux Refinery, Order on Petition Number VI-2012-04 (May 29, 2015) at 7-10. In the interest of providing additional transparency and clarity for the title V petition process, and for the public's convenience, the EPA repeats that interpretation in the following paragraphs.

When the EPA objects to a proposed permit under CAA section 505(b), section 505(b)(3) instructs that a permitting authority “may not issue the permit unless it is revised and issued” in accordance with section 505(c) of the Act. If the permit has already been issued by the permitting authority before it receives the objection, then the EPA “shall modify, terminate, or revoke” the permit, and the permitting authority may then only issue a revised permit in accordance with section 505(c) of the Act.

Under CAA section 505(c), if the permitting authority fails to submit a permit revised to meet the Administrator's objection within 90 days after the objection, the Administrator must issue or deny the permit in accordance with the requirements under title V. Section 505(c) further provides that no objection is subject to judicial review until the Administrator takes final action to issue or deny the permit.

Neither CAA section 505(b)(3) nor section 505(c) provide express direction as to the specific procedures and steps the EPA must use to “modify, terminate, or revoke” or “issue or deny” the permit, though section 505(c) points generally to the requirements under title V. Although the Act is ambiguous, the implementing regulations shed some light on the process. Those regulations provide a state with 90 days to resolve the EPA's objection and terminate, modify, or revoke and reissue the permit, before the EPA would need to begin to act on the permit. 40 CFR 70.8(d), 70.7(g)(4)-(5); see also 40 CFR 71.4(e) (the EPA will take permitting action under part 71, when, among other things, a state fails to respond to the EPA's objection). A permitting authority may address an EPA objection by, among other things, providing the EPA with a revised permit. See, e.g., 40 CFR 70.7(g)(4). In some cases, the permitting authority's response to an EPA objection may not involve a revision to the permit terms and conditions themselves, but may instead involve revisions to the permit record. As an example, a permitting authority might opt to include additional rationale and detail to support its decision in response to the EPA's objection if such objection was based on the grounds that the permit record does not adequately support the permitting authority's decision. Whether the permitting authority submits revised permit terms, a revised permit record, or other revisions to the permit, the permitting authority's response is generally treated as a new proposed permit.17

As described in previous title V orders, such as the 2013 Nucor II Order, the EPA has generally treated the permitting authority response as a new proposed permit which is subject to the agency's opportunity to conduct a 45-day review per CAA 505(b)(1) and 40 CFR 70.8(c), and an opportunity for a petition if the EPA does not object. As stated in the Nucor II Order:

The EPA's interpretation that a state's response to an EPA objection generally triggers a new EPA review and petition opportunity is consistent with, and a reasonable interpretation of, the statutory and regulatory process for addressing objections by the EPA, as explained previously. Accordingly, at the end of the 45-day review period, if the EPA does not object, there is a 60-day window in which there is an opportunity for a second petition. If a second petition is received, the EPA must respond to the petition within 60 days under CAA section 505(b)(2).

Costs associated with this proposed rule are expected to be minimal. Much of the focus in this proposal is to codify the established practice that has been publicly discussed and evolved over time. If finalized, the revisions should impose no costs on petitioners, and may reduce confusion over and the time necessary for preparing a title V petition. The agency anticipates that a small number of permitting authorities may need to amend their rules regarding permit issuance to require responses to significant comments and the submittal of those responses with the proposed permit that is sent to the EPA for review.

The existing part 70 regulations provide for state program revisions if part 70 is revised and the EPA determines such conforming changes are necessary. 40 CFR 70.4(a) and 70.4(i). The EPA is soliciting comment as to whether revisions to any approved state programs would be necessary if the revisions to part 70 regulations proposed in this notice are finalized. States are expressly encouraged to provide information on any changes to state rules and programs that may be necessary if the proposed revisions to 40 CFR 70.7(h) and 70.8 are finalized to require permitting authorities to respond in writing to all significant comments raised during the public participation process and to provide that response to the EPA for the agency's 45-day review period.

Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final agency actions by the EPA under the CAA. This section provides, in part, that petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit (i) when the agency action consists of nationally applicable regulations promulgated, or final actions taken, by the Administrator; or (ii) when such action is locally or regionally applicable, if the action is determined to be of nationwide scope or effect and the Administrator publishes such a determination. The EPA proposes to find and publish that this rule is based on a determination of nationwide scope and effect. This proposed rule concerns revisions to the EPA's regulations in part 70 for operating permit programs, and these regulations apply to permitting programs across the country. Accordingly, we propose to determine that this is a rulemaking of nationwide scope or effect such that any petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit.

This action proposes certain revisions to part 70 regulations to improve the title V petition submittal, review and response processes. The proposed revisions and guidance provided in this rule should increase the transparency and clarity of the petition process for all stakeholders. First, the establishment of centralized petition submittal is expected to reduce or eliminate confusion over where to submit a petition. When using the preferred method of an electronic petition submittal through the agency's electronic submittal system, a petitioner will also have immediate assurance that the petition and any attachments were received. However, alternative submittal methods are still available options for members of the public that experience technical difficulties when trying to submit a petition or for those that do not have access to electronic submittal mechanisms. Second, the proposed required content and format provides instruction and clarity on what must be included in a petition. This change is anticipated to assist petitioners in providing all the critical information in their petitions in an effective manner, which may increase the agency's efficiency in responding to petitions. Third, the proposed regulatory changes would require permitting authorities to respond to public comments in a written document that is provided to the EPA for the agency's 45-day review and is available during the 60-day opportunity to file a title V petition, which will provide increased availability of information regarding permits for the public in general and petitioners specifically. Further, this change may provide more timely notification of pertinent steps and documents in the permit issuance process. Fourth, the recommended practices for permitting authorities and sources, if followed, may improve the quality of public participation and the operating permits being issued. Finally, the description of the post-petition process is anticipated to reduce confusion regarding the appropriate steps when the EPA grants a petition for an objection on a particular issue. This proposed action does not compel any specific changes to the requirements to provide opportunities for public participation in permitting nor does it finalize any particular permit action that may affect the fair treatment and meaningful involvement of all people. Further, this proposed action is responsive to some of the feedback received during the Environmental Justice in Permitting workshops the agency provided in the North Birmingham area on September 15 and 16, 2014 and other such meetings held in EPA's Region 4.

In preparation for this proposal, the agency participated in community calls where the EPA presented a brief overview and announcement of the rulemaking effort. The EPA provided additional details about a planned webinar that will describe the title V petition process, the content of this proposal, and when and how to submit comments.

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

This action would not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0243 for the title V part 70 program. To the extent that a SIP revision or a title V program revision is necessary to effect the changes being proposed, we believe that the burden is already accounted for under the approved information collection requests noted earlier.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This proposed action would not impose any requirements directly on small entities. Entities potentially affected directly by this proposal include anyone that chooses to submit a title V petition on a proposed title V permit prepared by an EPA-approved state, local or tribal title V permitting authority. Other entities directly affected may include state, local, and tribal governments and none of these governments are small governments. Other types of small entities are not directly subject to the requirements of this action.

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

This action does not have federalism implications. It will not have substantial direct 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.

This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. The Southern Ute Indian Tribe has an EPA-approved operating permit program under 40 CFR part 70 and could be impacted. The EPA conducted outreach to the tribes through a call with the National Tribal Air Association. Further, the agency plans to offer consultation to all tribal governments, and will specifically offer to consult with the Southern Ute Indian tribe. The EPA solicits comment from affected tribal governments on the implications of this proposed rulemaking.

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

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes the human health and environmental risk addressed by this proposed action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The results of this evaluation are contained in Section VIII of this notice titled, “Environmental Justice Considerations.”

Section 307(d)(1)(V) of the CAA provides that the provisions of CAA section 307(d) apply to “such other actions as the administrator may determine.” Pursuant to CAA section 307(d)(1)(V), the Administrator determines that this proposed action is subject to the provisions of CAA section 307(d).

The statutory authority for this proposed action is provided by 42 U.S.C. 7401 et seq.

For the reasons stated in the preamble, title 40, Chapter I of the Code of Federal Regulations is proposed to be amended as set forth below.

The revisions and additions read as follows:

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

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

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

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after September 23, 2016 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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

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

EPA is proposing these SNURs under TSCA section 5(a)(2) for two chemical substances which were the subject of PMNs P-14-321 and P-14-323. These SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.

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

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

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

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

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

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

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

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

EPA is proposing significant new use and recordkeeping requirements for two chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

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

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

• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VII. for more information).

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

The regulatory text section of this proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture volume) and other uses designated in this proposed rule, may be claimed as CBI.

Chemical name: Hydrochlorofluoropropane and Hydrochlorofluoropropene (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: August 12, 2016.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substances will be as site-limited, isolated and recycled intermediates. Based on test data on the PMN substances, EPA identified concerns for acute toxicity including lethality to animals. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires:

1. Submission of certain toxicity testing on the PMN substances prior to exceeding the time trigger specified in the consent order of the PMN substances.

2. Use of impervious gloves and protective clothing where dermal exposure is reasonably likely for workers.

3. Use of respirators with an APF of 1000, in conjunction with a minimum set of engineering controls to prevent inhalation exposure for workers, or, as an alternative to using respirators, maintain workplace airborne concentrations of the PMN substances at or below a specified New Chemical Exposure Limit (NCEL) of 130 parts per million (ppm) for P-14-321 and 33 parts per billion (ppb) for P-14-323 as an 8-hour time-weighted average, where inhalation exposure is reasonably likely for workers.

4. Use of engineering controls to limit worker exposure and air release of the PMN substances to the environment.

5. Label containers of the PMN substances and provide Safety Data Sheets and worker training.

6. Manufacture, process and use the PMN substances only in an enclosed process.

7. Use of the PMN substances only as chemical intermediates.

8. No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States that result in surface water concentrations exceeding 8 ppb.

9. Prohibition on the distribution of the PMN substances.

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

Recommended testing: EPA has determined that the results of a subacute inhalation toxicity: 28-day study (OECD Test Guideline 412) in three species: Mouse, rat, and rabbit (6 studies total) and a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD Test Guideline 422) would help characterize the human health effects of the PMN substances. The submitter has agreed to complete this testing by the production limits identified in the consent order.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to §  721.160 (see Unit VI.).

EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this proposed rule:

• EPA would receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

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

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

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at https://www.epa.gov/tsca-inventory.

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

When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identities of the two chemical substances subject to this proposed rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

Therefore, EPA designates August 15, 2016 (the date of public release/web posting of this proposal) as the cutoff date for determining whether the new use is ongoing. This designation varies slightly from EPA's past practice of designating the date of Federal Register publication as the date for making this determination. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule. In developing this proposal, EPA has recognized that, given EPA's practice of now posting proposed rules on its Web site a week or more in advance of Federal Register publication, this objective could be thwarted even before that publication. Thus, EPA has slightly modified its approach in this rulemaking and plans to follow this modified approach in future significant new use rulemakings.

Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of August 15, 2016 would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacture or processing have been satisfied. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 (55 FR 17376) for a more detailed discussion of the cutoff date for ongoing uses.

EPA recognizes that TSCA section 5 does not require developing new information (e.g., generating test data) before submission of a SNUN. There is an exception:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule, order, or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a test rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Guidelines for Pesticides and Toxic Substances.”

The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN that does not itself include information sufficient to permit a reasoned evaluation may increase the likelihood that EPA will either respond with a determination that the information available to the Agency is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use or, alternatively, that in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs and define the terms of any potentially necessary controls if the submitter provides detailed information on:

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

• Potential benefits of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what information may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the risk assessment documents included in the public docket.

The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Unit II and in the documents noted above. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitely. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule, during the development of the direct final rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2016-0491.

This proposed rule would establish SNURs for two chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

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

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

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

On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

A copy of that certification is available in the docket for this proposed rule.

This proposed rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

• Submission of the SNUN would not cost any small entity significantly more than $8,300.

Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

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

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

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

This proposed rule is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this proposed rule does not address environmental health or safety risks disproportionately affecting children.

This proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.

In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would not apply to this proposed rule.

This proposed rule does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

This is a summary of the Commission's Further Notice of Proposed Rulemaking (Further Notice), document DA 16-893, adopted on August 4, 2016, and released on August 4, 2016. The full text of this document is available for public inspection and copying via ECFS, and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. This document can also be downloaded in Word or Portable Document Format (PDF) at: https://www.fcc.gov/general/disability-rights-office-headlines. The proceeding initiated by the Further Notice shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 47 CFR 1.1200 et seq. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with 47 CFR 1.1206(b). In proceedings governed by 47 CFR 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (844) 432-2275 (videophone), or (202) 418-0432 (TTY).

The Further Notice does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

1. In 2013, the Commission amended its rules to improve the effectiveness of its interoperability and portability rules for video relay service (VRS), in order to improve functional equivalence and VRS availability for consumers, ease of compliance by providers, and overall efficiency in the operation of the telecommunications (TRS) program. The Commission directed Commission staff to support and participate in the ongoing Session Initiation Protocol (SIP) Forum's VRS Task Group process in order to ensure the timely development of such consensus standards. Structure and Practices of the Video Relay Service Program; Telecommunications Relay Services and Speech-to-Speech Services for Individuals With Hearing and Speech Disabilities, published at 78 FR 40582, July 5, 2013 (VRS Reform Order).

2. The Further Notice, issued by CGB pursuant to a delegation of authority in the VRS Reform Order, proposes to incorporate by reference into the Commission's VRS interoperability rule the interoperability and portability standards produced by the VRS Task Group of the SIP Forum and a successor group, the Relay User Equipment (RUE) Forum, along with a process that will readily enable revisions to this rule to reflect future amendments or changes in these standards. In addition, this document proposes guidance on implementation of the standards, including the need for a transition period for existing VRS access technologies to achieve interoperability and portability.

3. Since 2006, the Commission has required VRS providers to (i) allow VRS users to make and receive calls through any VRS provider, and to choose a different default provider, without changing the VRS access technology they use to place calls, and (ii) ensure that VRS users can make point-to-point calls to all other VRS users, irrespective of the default provider of the calling and called party. Providers also must ensure that videophone equipment that they distribute retains certain features when a user ports his or her ten-digit VRS number to a new default provider. 47 CFR 64.611(e); VRS Reform Order.

4. In order to improve the effectiveness of these interoperability and portability requirements, the Commission delegated “to the Chief of CGB, after consultation with the CTO [Chief Technology Officer] and the Chief of OET [Office of Engineering and Technology], the authority to conduct rulemaking proceedings to incorporate into the Commission's rules by reference any interoperability and portability standards developed under the auspices of the SIP Forum, now or in future, or such other voluntary, consensus standard organization as may be formed to address these issues.” VRS Reform Order. The VRS Reform Order further provided: “Recognizing that the scope of the SIP Forum VRS Task Group charter extends beyond the Commission's current mandatory minimum standards, the Commission also delegates to Chief of CGB, after consultation with the CTO and the Chief of OET, the authority to conduct rulemaking proceedings to incorporate into the Commission's rules by reference as new or updated mandatory minimum standards any standards or recommended standards developed by the SIP Forum (or such other voluntary, consensus standard organization as may be formed to address these issues) that the Chief of CGB finds will advance the statutory functional equivalency mandate or improve the availability of TRS, in the most efficient manner. In conducting such rulemakings, the Chief of CGB shall provide guidance on implementation, including the need for a transition period for existing VRS access technologies, complaint resolution, or other actions necessary to ensure full interoperability and portability.”

5. In August 2015, the SIP Forum published the Video Relay Service (VRS) Provider Interoperability Profile (VRS Provider Interoperability Profile), a consensus document developed by the SIP Forum's VRS Task Group. The VRS Provider Interoperability Profile provides technical specifications for the interface between VRS providers and the interface between a VRS provider and the TRS Numbering Directory. In July 2016, the Relay User Equipment Forum (RUE Forum) published a second consensus document, the Interoperability Profile for Relay User Equipment (RUE Profile) on the Internet Engineering Task Force (IETF) Web site. The RUE Profile provides technical specifications that define a standard interface between a relay user's equipment and the services offered by relay service providers.

6. The Bureau tentatively concludes that the VRS Provider Interoperability Profile and the RUE Profile will effectively meet the Commission's goals of ensuring interoperability and portability, as required by the VRS Reform Order. Specifically, these standards will enable a VRS user to place and receive calls through any VRS provider and make point-to-point calls to all other VRS users, irrespective of the default provider of the parties to the call, and without the caller having to change the VRS access technology used to make such calls. Additionally, as required by the VRS Reform Order, these standards will support a standard data interchange format for exporting and importing private data contained in a user's personal contacts list (also referred to as an address book) and the user's speed dial list between the VRS user's access technology and the access technology of other VRS providers. In these various ways, these standards will “advance the statutory functional equivalency mandate [and] improve the availability of TRS, in the most efficient manner,” in accordance with the VRS Reform Order. The Bureau further notes that all current VRS providers participated in the process leading to adoption of the standards, and that all providers appear to have reached a consensus on these standards. For all of these reasons, the Bureau tentatively concludes that these standards meet the Commission's objective of facilitating interoperability and portability for VRS, and should be incorporated by reference into the Commission's rules. The Bureau seeks comment on this tentative conclusion and its rationale. The Bureau also seeks comment on whether any modified version of the standards that results from the continued work of the RUE Forum, which is published subsequent to the Commission's release of the Further Notice and during the pendency of this proceeding, should be adopted in lieu of the versions of the standards discussed above.

7. The Bureau also proposes to follow, in the future, a procedure that permits amendments or changes to the standards to be incorporated into the Commission's rules in a timely and efficient manner. The Bureau believes that a voluntary, consensus standards process that results in amendments or changes to the standards will, as is the case for the standards proposed for incorporation herein, allow for widespread participation by the affected parties, and in particular VRS providers. In the event of such amendments or changes, the Bureau will issue a public notice seeking comment on such modifications, followed by an order incorporating into the VRS rules amendments or changes by reference if justified based on the resulting record. When such revised standards are completed and accepted by the Bureau, a second public notice will be issued containing information on how to access the modified standards and establishing an implementation schedule. To facilitate ready access to such standards, the Bureau further proposes that the Commission make them available to the public online. The Bureau believes that this process will allow interested parties to have the opportunity to participate in the standards-setting process, comment on the inclusion of such standards in the Commission's rules, and receive notice about the implementation of any amendments or changes to the standards. The Bureau seeks comment on this approach and on any alternatives.

8. As to the timing of the implementation of the recently developed standards, the Bureau believes that insofar as all current VRS providers participated in developing these standards and had an opportunity to debate the various technical issues over a period of several years, as a practical matter, all providers have become familiar with the content of the standards, have had ample opportunity to incorporate the standards into their software development processes, and have had sufficient opportunity to familiarize their suppliers with any necessary design changes. The Bureau therefore proposes that the rule amendment incorporating the standards into 47 CFR 64.621 shall become effective 60 days after publication in the Federal Register of the amended rule. The Bureau seeks comment on this proposed implementation schedule. To the extent that any commenter seeks a later effective date, the Bureau requests that such commenter describe the specific products or features and functions for which a later effective date is needed and the reasons why compliance is not achievable at an earlier date.

9. As the Commission contemplated in the VRS Reform Order, once incorporated into the Commission's rules, compliance with the standards “shall be a prerequisite for compensation from the Fund. No VRS provider shall be compensated for minutes of use generated by non-standards compliant VRS access technologies or otherwise generated in a manner inconsistent with the Commission's rules. If a provider cannot reliably separate minutes of use generated through standards compliant VRS access technologies from those generated through non-standards compliant VRS access technologies, the provider will not receive compensation for any of the minutes.” VRS Reform Order.

10. The Office of Federal Register (OFR) recently revised its regulations to require that agencies must discuss in the preamble of a proposed rule ways that the materials the agency proposes to incorporate by reference are reasonably available to interested parties or how it worked to make those materials reasonably available to interested parties. In addition, the preamble of the proposed rule must summarize the material. 1 CFR 51.5(a). In accordance with OFR's requirements, the discussion in the following two paragraphs summarizes and indicates the availability of the VRS Provider Interoperability Profile and the RUE Profile.

11. The U.S. Video Relay Service (VRS) Provider Interoperability Profile, Version 15, SIP Forum Document Number: VRS U.S. Providers Profile TWG-6-0.15 (Sept. 23, 2015) (VRS Provider Interoperability Profile), is available from SIP Forum LLC, 733 Turnpike Street, Suite 192, North Andover, MA 01845 USA, (203) 829-6307, at http://www.sipforum.org/component/option,com_docman/task,cat_view/gid,160/Itemid,75/. The Provider Interoperability Profile provides technical specifications for the interface between VRS providers and the interface between a VRS provider and the TRS Numbering Directory.

12. The Interoperability Profile for Relay User Equipment, draft-vrs-rue-dispatch-00 (July 20, 2016) (RUE Profile), is available from IETF Secretariat, 5177 Brandin Court, Fremont, CA 94538, 510-492-4080, at https://www.ietf.org/id/draft-vrs-rue-dispatch-00.txt. The RUE Profile provides technical specifications that define a standard interface between a relay user's equipment and the services offered by relay service providers.

13. As required by the Regulatory Flexibility Act (RFA), the Bureau has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in the Further Notice. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments specified in the Further Notice.

14. Need For, and Objectives of, the Proposed Rules. In the VRS Reform Order, the Commission strongly encouraged the continuation of efforts by the SIP Forum's VRS Task Group to develop voluntary, consensus standards to facilitate interoperability and portability of VRS and directed Commission staff to support and participate in the SIP Forum process. The SIP Forum and a successor group, the RUE Forum, have now produced interoperability and portability standards, making it possible to achieve the improvements sought in the VRS Reform Order. The Further Notice proposes to incorporate those interoperability and portability standards by reference into 47 CFR 64.621, the Commission's VRS interoperability rule, along with guidance on implementation, including the need for a transition period for existing VRS access technologies to achieve interoperability and portability. In addition, the Further Notice proposes a process that will readily enable revisions to this rule to reflect future amendments or changes in these standards by issuing a public notice seeking comment on such modifications, followed by an order incorporating into the VRS rules amendments or changes by reference if justified based on the resulting record, after which a second public notice will be issued containing information on how to access the modified standards online and establishing an implementation schedule.

15. Legal Basis. The legal basis for any action that may be taken pursuant to the Further Notice is contained in 47 U.S.C. 151, 152, 154(i), 154(j), 225, 303(r).

16. Types of Small Entities to Which the Proposed Rules May Apply. All Other Telecommunications.

17. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements. If the Commission were to incorporate the SIP Forum and RUE Forum standards by reference into the Commission's VRS interoperability rule and provide guidance on implementation, VRS providers, including small entities, would need to take steps to comply with such standards.

18. Steps Taken to Minimize Significant Economic Impact on Small Entities and Significant Alternatives Considered. In general, alternatives to proposed rules are discussed only when those rules pose a significant adverse economic impact on small entities. In this context, however, the proposed rules generally confer benefits. In particular, interoperability requirements benefit the smaller providers because consumers find the services of smaller providers to be more attractive when these services are interoperable than when they are not interoperable. These benefits outweigh any burdens associated with compliance. Moreover, because all of the VRS providers participated in the discussions associated with the development of the standards, the Commission believes that these standards are acceptable to all VRS providers, including small entities. Lastly, the Further Notice seeks comment on the proposed implementation schedule to ensure that such implementation schedule is achievable.

19. Federal Rules that May Duplicate, Overlap, or Conflict with Proposed Rules. None.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 64 as follows:

Viewing wild marine mammals in Hawaii has been a popular recreational activity for both tourists and residents over the past several decades. Historically, most marine mammal viewing focused on humpback whales (Megaptera novaeangliae) during the winter months when the whales migrate from their feeding grounds off the coast of Alaska to Hawaii's warm and protected waters to breed and calve. However, increased viewing has focused on small cetaceans, with a particular emphasis on Hawaiian spinner dolphins (Stenella longirostris), which can be predictably found close to shore in shallow waters throughout the MHI.

The number of commercial operators engaged in wild dolphin viewing has grown dramatically in Hawaii in recent years (O'Connor 2009), putting new pressures on easily accessible groups of resting Hawaiian spinner dolphins. In addition, a number of residents and visitors venture on their own, independent of commercial operators, to view and interact with spinner dolphins. The expectation for close interactions with wild dolphins has been encouraged by some operators and various media outlets, which routinely contradict established wildlife viewing guidelines by promoting close vessel or in-water encounters with the dolphins.

We have received many complaints that spinner dolphins are being routinely disturbed by people attempting to closely approach and interact with the dolphins by boat or other watercraft (e.g., kayaks), or in the water (e.g., snorkel or “swim-with-wild-dolphins” activities). In addition, concerns over human-dolphin interactions have been expressed by officials from the Hawaii Department of Land and Natural Resources (DLNR) and the U.S. Marine Mammal Commission (MMC), as well as various members of the public, including representatives of the Native Hawaiian community, scientific researchers, wildlife conservation organizations, public display organizations, and some commercial tour operators.

In 2010, we recognized five island-associated stocks and one pelagic stock of Hawaiian spinner dolphins in our annual Stock Assessment Report, identifying genetic distinctions and site fidelity differences as reasons to separately manage stocks found in waters surrounding the Hawaiian Islands (Carretta et al. 2010). Three of the five island-associated stocks (the Kauai/Niihau stock, Oahu/4 Islands (i.e., Maui County) stock, and Hawaii Island stock) are found near the MHI and are considered resident stocks. These three stocks reside in waters surrounding their namesake islands out to approximately 10 nm (18.5 km) (Hill et al. 2010), and population estimates for each stock are relatively small. Recent research indicates that the Hawaii Island stock, which is thought to be the largest stock, has an estimated 631 individuals (Coefficient of Variation (CV) = 0.09) (Tyne et al. 2014, Carretta et al. 2016). Data for other stocks in the MHI is limited; however, using the best available information, the Kauai/Niihau and Oahu/4 Islands stocks are estimated to be around 601 (CV = 0.20) and 355 (CV = 0.09) individuals, respectively (Carretta et al. 2016).

Island-associated spinner dolphins, such as those found in the MHI, have complex social structures and behavioral patterns linked to specific habitats that support their high energetic demands. The rigid, cyclical, and patterned behavior of a Hawaiian spinner dolphin's day is well documented from decades of scientific research on spinner dolphins off the Kona coast on the island of Hawaii (Norris and Dohl 1980, Norris et al. 1994). The daily pattern of Hawaiian spinner dolphins has been characterized as “working the night shift,” because the energetically demanding task of foraging is accomplished nightly when spinner dolphins move offshore in large groups to feed. Spinner dolphins feed on fish, shrimp, and squid found in the mesopelagic boundary community, part of the pelagic zone that extends from a depth of 200 to 1,000 m (~660 to 3,300 feet) below the ocean surface. Spinner dolphins maximize their foraging time by actively moving with, or tracking, the horizontal migration of the mesopelagic boundary community throughout the night, as it moves inshore until midnight and then offshore around sunrise (Benoit-Bird and Au 2003). Spinner dolphins are acoustically very active during foraging activities (Norris et al. 1994), working cooperatively in large groups using coordinated movements to maximize foraging potential (Benoit-Bird 2004).

During the day, spinner dolphins return in smaller groups to areas closer to shore to socialize, nurture their young, and rest in preparation for nightly foraging (Norris et al. 1994). These smaller groups visit specific habitats that are located along the coastlines of the MHI. These preferred daytime habitats of spinner dolphins are areas that provide space with optimal environmental conditions for resting, socializing, and nurturing young, and are referred to hereafter as “essential daytime habitats.” Spinner dolphins' essential daytime habitats are located close to offshore feeding areas, which minimizes the energetic cost of nightly travel to these areas (Norris et al. 1994, Thorne et al. 2012). Additionally, essential daytime habitats have large patches of sand bottom habitat, which increases the dolphins' ability to visually (instead of acoustically) detect predators while resting, and thus minimizes the energetic costs of vigilance (Norris et al. 1994). Throughout the day, spinner dolphins take advantage of the physical characteristics of essential daytime habitats to engage in specific patterned resting behaviors to recuperate between foraging bouts. The physical characteristics of these essential daytime habitats, combined with specific patterned resting behaviors, play an important role in supporting the dolphins' activity and energetic budgets.

Essential daytime habitats have been targeted by commercial operators and individuals interested in viewing or interacting with Hawaiian spinner dolphins because encounters with dolphins in these areas are virtually guaranteed. At some locations, up to 13 tour boats have been observed jockeying for position on a single dolphin group, with up to 60 snorkelers in the water (Heenehan et al. 2014). Apart from commercial tour operations, people also swim, kayak, or paddle into essential daytime habitats to seek interactions with the dolphins (Sepez 2006). In addition, organized retreats centered on dolphin encounters, dolphin-assisted therapy, and dolphin-associated spiritual practices have flourished in certain areas, further increasing the intensity of dolphin-directed activities in nearshore areas and especially within essential daytime habitats (Sepez 2006).

There is a growing body of scientific evidence documenting the effects of dolphin-directed activities on spinner dolphins, especially activities that involve close approaches by humans. Peer-reviewed scientific literature documents disturbance of individual spinner dolphins as well as changes to spinner dolphin group behavioral patterns. Individual dolphin responses to these activities vary, and in some cases may not be apparent to an observer (e.g., elevated heart rates or increased watchfulness). However, discernable responses may include aerial displays when closely approached by vessels and swimmers (Forest 2001, Courbis and Timmel 2008); avoidance behaviors, including moving around and away from swimmers and vessels, or leaving the area in response to human pursuit (Ostman-Lind et al. 2004, Courbis 2004, Courbis and Timmel 2008); and aggressive behaviors directed at people, including charging or threat displays (Norris et al. 1985, Norris et al. 1994).

Effects have been documented in the form of changes over time to spinner dolphins' behavioral patterns in essential daytime habitats, where spinner dolphins' behavioral patterns are easily observed. Courbis and Timmel (2008) reported differences in peak aerial activity throughout the day in comparison with earlier studies (Forrest 2001) and noted that dolphins may have reduced aerial behavior when entering and exiting bays to avoid human notice and approaches. Timmel et al. (2008) noted the dolphins' direction of travel altered more frequently as the number of swimmers and/or vessels near to them increased. Symons (2013) found that spinner dolphins are less likely to rest when swimmers are present within 150 m. Numerous studies report changes in dolphin residence time within essential daytime habitats compared to earlier studies (Courbis 2004, Courbis and Timmel 2008, Ostman-Lind 2007, Forest 2001). In addition, human activities within essential daytime habitats may be affecting where spinner dolphins engage in their daytime behaviors within these areas. Courbis and Timmel (2008) reported changes in the location of resting spots within Kealakekua Bay from previous studies by Doty (1968) and Norris and Dohl (1980), and warned that changes in locations within the bay could be a precursor to abandonment of the bay with future increases in traffic.

Hawaiian spinner dolphin studies off the island of Oahu also demonstrate the effects of swimmers on dolphins' daily resting behavioral patterns. As the number of swimmers increased in an essential daytime habitat off the west coast of Oahu, the dolphins departed the area at earlier times during the day, possibly indicating reduced rest periods in response to swimmer presence (Danil et al. 2005). Additionally, Danil et al. (2005) noted that on several occasions, smaller spinner dolphin groups (<25 animals) refrained from entering an essential daytime habitat when swimmer presence was high, suggesting that the observed spinner dolphin rest patterns were altered in order to accommodate and adapt to the swimmers' occurrence. The authors predicted that swimmer presence keeps the dolphins in a constant state of alertness and vigilance, and that delayed diving behavior (in the morning during swimmers' presence) may indicate a diminished quality of rest (Danil et al. 2005).

When marine mammals respond to disturbance events, they incur a cost in the form of the energy expended to respond as well as the lost opportunity to engage in natural fitness-enhancing behavior. For example, spinner dolphins disturbed during rest may engage in avoidance or distress behaviors, which require energy, and disturbance detracts from the dolphins' abilities to recuperate from energetically demanding behaviors such as foraging, transiting to and from offshore foraging grounds, and nurturing their young. In this example, the lack of consistent, undisturbed resting periods can reduce the amount of energy available to forage and care for young.

The predictable patterns of MHI resident spinner dolphins' nearshore distribution and daytime behaviors result in concentrated daily viewing and interaction pressure on individual dolphins and groups over extended periods of time. In other small cetacean populations, chronic disturbance to natural behavioral patterns has been linked to biologically significant impacts such as habitat abandonment and reduced female reproductive success (Bejder 2005; Bejder et al. 2006a, 2006b; Lusseau and Bejder 2007). Similarly, over time, chronic disturbance to the MHI's resident spinner dolphins could ultimately lead to habitat displacement and/or long term impacts to their individual fitness. These types of impacts may be amplified in resident, closed or isolated populations (local populations with barriers to gene flow) (Bejder 2005) because the impacts to multiple individuals' health and fitness are quickly reflected in the overall fitness of the population. Accordingly, the small resident spinner dolphin populations of the MHI may be more vulnerable to negative impacts from human disturbance.

Disturbances to dolphins' daily behavioral patterns may result in “take,” as defined and prohibited under the MMPA and its implementing regulations, and the chronic nature of these problems in Hawaii and observed changes to spinner dolphin behavioral patterns over time are a cause for concern.

Under section 102 of the MMPA, 16 U.S.C. 1361 et seq., it is unlawful for any person, vessel, or other conveyance to “take” any marine mammal in waters under the jurisdiction of the United States (16 U.S.C. 1372). The prohibition against take includes acts that “harass” marine mammals (16 U.S.C. 1362(13)). Harassment means any act of pursuit, torment, or annoyance which has the potential to injure a marine mammal in the wild (Level A Harassment), or has the potential to disturb a marine mammal in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B Harassment) (16 U.S.C. 1362(18); see also 50 CFR 216.3).

In addition, NMFS' regulations implementing the MMPA further define the term “take” to include “the negligent or intentional operation of an aircraft or vessel, or the doing of any other negligent or intentional act which results in disturbing or molesting a marine mammal; and feeding or attempting to feed a marine mammal in the wild” (50 CFR 216.3).

Section 112 of the MMPA authorizes NOAA to implement regulations that are “necessary and appropriate to carry out the purpose” of the MMPA (16 U.S.C. 1382).

To date, NMFS has developed specific approach distance regulations for certain species of marine mammals listed under the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.). Each rule was based on the biology of the marine mammals and the best available scientific information on the nature of the threats. Examples of these types of regulations include a 100-yard (91.4 m) approach limit for humpback whales in Hawaii (60 FR 3775; January 19, 1995); a 100-yard approach limit for humpback whales in Alaska, which includes a speed restriction in the vicinity of the whale (66 FR 29502; May 31, 2001); a 500-yard (457.2 m) approach limit for North Atlantic right whales (62 FR 6729; February 13, 1997); size-specific vessel speed restrictions within specific areas in waters off the U.S. East Coast to protect North Atlantic right whales (73 FR 60173; October 10, 2008); and a 200-yard (182.9 m) approach limit for killer whales with prohibitions against vessels intercepting a killer whale or positioning the vessel in its path in the inland waters of Washington State (76 FR 20870; April 14, 2011).

In addition to the specific ESA regulations mentioned above, NMFS has developed guidelines for conducting responsible marine wildlife viewing to help the public avoid causing any take (harassment or disturbance) of protected wildlife species (http://www.nmfs.noaa.gov/pr/pdfs/education/viewing_wildlife.pdf); these guidelines have been available since 2004. On human interactions with marine mammals in the wild, NMFS states the following: “The MMPA does not provide for a permit or other authorization to view or interact with wild marine mammals, except for specific listed purposes such as scientific research. Therefore, interacting with wild marine mammals should not be attempted and viewing marine mammals must be conducted in a manner that does not harass the animals. NMFS does not support, condone, approve, or authorize activities that involve closely approaching, interacting, or attempting to interact with whales, dolphins, porpoises, seals, or sea lions in the wild. This includes attempting to swim with, pet, touch, or elicit a reaction from the animals” (http://www.nmfs.noaa.gov/pr/dontfeedorharass.htm).

In addition to the national guidelines, each of the five NMFS Regions has developed recommended viewing guidelines relevant to protected species within their region to assist the general public with information on how to responsibly view and act around these animals in the wild. The guidelines are aimed at assisting the public in meeting their obligations under the MMPA and ESA. Although some guidelines address activities that are prohibited under law, others address activities that are not expressly prohibited.

The NMFS Pacific Islands Regional Office's viewing guidelines for Hawaii recommend that people view wild dolphins from a safe distance of at least 50 yards (45.7 m) and advise against trying to chase, closely approach, surround, swim with, or touch the animals. To support the guidelines in Hawaii, NMFS has partnered with the State of Hawaii and the Hawaiian Islands Humpback Whale National Marine Sanctuary over the past several years to promote safe and responsible wildlife viewing practices through the development of outreach materials, training workshops, signage, and public service announcements. NMFS' education and outreach efforts have also been supported by a partnership with the Watchable Wildlife program, a consortium of Federal and State wildlife agencies and wildlife interest groups that encourages passive viewing of wildlife from a distance for the safety and well-being of both animals and people (Duda 1995, Oberbillig 2000, Clark 2006). In addition to the guidance provided to the general public on protected wildlife viewing, several tour industry-specific programs have been initiated in various NMFS regions to further support protection of marine mammals targeted for wildlife viewing. In Hawaii this includes administration of the voluntary Dolphin SMART program for commercial operators who pledge to comply with safe and responsible wildlife viewing practices.

Dolphin SMART is a model wildlife viewing stewardship program developed by NMFS and NOAA's Office of National Marine Sanctuaries in partnership with Whale and Dolphin Conservation, the Dolphin Ecology Project, local businesses, and members of the public, who have teamed up to support responsible viewing of wild dolphins. The program was launched in 2007 in Key West, Florida, was subsequently expanded to the Central and Southwest Florida coast, and established in Hawaii in 2011.

The NMFS Pacific Islands Regional Office developed the Dolphin SMART program in Hawaii to aid education and outreach efforts for Hawaiian spinner dolphin conservation and management. Three businesses on Oahu, one on Kauai, and two on Maui are currently recognized as Dolphin SMART participants.

The Dolphin SMART program goals are to minimize the potential of wild dolphin harassment caused by commercial viewing activities, reduce expectations of close interaction with wild dolphins in a manner that may cause harassment, address advertising that creates expectations of engaging in activities that may cause harassment, and promote responsible stewardship of dolphins in local coastal waterways. The “SMART” acronym stands for:

More information on the Dolphin SMART program can be found at the following Web sites: www.dolphinsmart.org and www.facebook.com/OfficialDolphinSmart.

Despite the prohibitions, guidelines, outreach, and stewardship efforts currently in place, close interactions between humans and spinner dolphins continue to occur in Hawaii's waters and are especially prevalent in essential daytime habitats (see Background). In April 2000, the MMC released a literature review of scientific publications that evaluated the impacts of swimming with wild dolphins worldwide (Samuels et al. 2000). The authors of this review noted the prevalence of disturbances by tourist activities in areas critical to the animals' well-being, and recommended that precautions be taken to protect the dolphins (Samuels et al. 2000).

The concerns about disturbance to spinner dolphins by boaters and swimmers prompted NMFS to raise the topic of enhancing protections for these animals in an Advanced Notice of Proposed Rulemaking (ANPR) (70 FR 73426, December 12, 2005). Public comments received in 2005 reiterated and reinforced the concerns expressed by the MMC. In the years since the 2000 Samuels et al. review, additional scientific evidence has documented disturbances or disruptions to spinner dolphins by boaters or swimmers (Forest 2001; Courbis 2004, 2007; Danil et al. 2005; Timmel 2005; Courbis and Timmel 2009; Ostman-Lind 2009; Symons 2013; Heenehan et al. 2014; Tyne et al. 2015). This problem is pronounced in essential daytime habitats that are targeted for dolphin-directed activities, and animals that use these areas are exposed to intense activity on a daily basis. For example, a recent study found that human activities took place within 100 m of spinner dolphins 83 percent of the time the animals were using four essential daytime habitats on the island of Hawaii (Tyne 2015).

Based on extensive review and analysis through internal scoping, external scoping via the ANPR, public scoping for the DEIS, and the best available scientific information, we have determined that the existing prohibitions, regulations, and guidelines need to be strengthened to protect Hawaiian spinner dolphins from various forms of take from human activities that cause harassment or disturbance. Dolphins' response to disturbance varies among individuals, but in most cases it includes a departure from natural behavioral patterns that support the animal's health and fitness, and chronic disturbance may result in negative impacts to the fitness of individuals and/or populations. We therefore deem it necessary and appropriate to adopt additional regulations to clarify human activities that result in take of Hawaiian spinner dolphins, including harassment or other forms of disturbance as currently defined by statute and regulation.

Although unauthorized take of dolphins continues to be illegal wherever it occurs, we are focusing these regulations in nearshore areas, out 2 nm (3.7 km) from shore of the MHI and including designated waters between Lanai, Maui, and Kahoolawe (see Figures 1 and 2 in section 216.20(e) and Geographic Area section below), where the threat from dolphin-directed activities is concentrated and where spinner dolphins engage in daytime behaviors, including resting, socializing, nurturing, and traveling. These additional measures are intended to prevent “take” during important resting periods and allow Hawaiian spinner dolphins to engage in normal fitness-enhancing behaviors, thereby preventing long-term negative impacts to individuals and to the population.

In 2005, NMFS convened a Spinner Dolphin Working Group with representatives from the MMC, State and Federal agencies, and scientific researchers who work on spinner dolphin conservation concerns. The group evaluated the best available information at the time to understand the scope of the tourist and recreational activities targeting spinner dolphins. As noted above (Need for Additional Action section), in December 2005, we published an ANPR in the Federal Register (70 FR 73426, December 12, 2005) to solicit input from the public on potential ways to better enhance protections for spinner dolphins and mitigate activities of concern (e.g., close approach and swim-with activities). This was followed by a Notice of Intent (NOI) to Prepare an Environmental Impact Statement (EIS) under the National Environmental Policy Act (NEPA) (71 FR 57923; October 2, 2006), in which we identified a preliminary list of potential regulations for future consideration and comment, which included partial time-area closures in certain spinner dolphin essential daytime habitats, a minimum distance limit for approaching dolphins in the wild, restrictions on certain human behaviors in NMFS-identified spinner dolphin resting areas, and complete closure of all known spinner dolphin resting areas in the MHI.

During the ANPR and the NOI comment periods, five public scoping meetings were held on the islands of Kauai, Oahu, Maui, and Hawaii, and oral statements were taken at each meeting. NMFS received a total of 4,641 public comments in response to the ANPR and the NOI (this includes all emails, letters, and public testimonies). Comments were submitted by concerned citizens, tour operators, scientific researchers, conservation and education groups, and Federal, State, and other government entities.

Comments received through both of the public comment periods varied widely and recommended numerous actions to consider, ranging from no regulations to permanent closure of areas used by the dolphins for rest and shelter. Additionally, public comments raised concerns about various topics that should be addressed in the EIS or proposed action. These concerns are grouped into various topics in the final scoping report, and include the following topics: Hawaiian spinner dolphin biology and behavior; cultural issues; cumulative effects; data/data gaps; direct and indirect effects; education/outreach; enforcement; the ESA; guidelines/solutions for other species or from other countries; human-dolphin interaction, medical benefits from swimming with dolphins; MMPA; monitoring; the NEPA; public and stakeholder involvement; regulatory regime; social and economic issues; spiritual and religious issues; take and harassment, traditional Hawaiian knowledge; and welfare of the dolphins. Although comments varied greatly, a consistent theme that stood out under several topics was the need for effective and enforceable regulations.

As a result of stakeholder concerns expressed through these public comments, and for the preparation of this rule and associated DEIS, we made multiple site visits to areas where concerns have been raised regarding Hawaiian spinner dolphin disturbance in the MHI. During these visits, we met with concerned members of the public to gather information relevant to this analysis. Additionally, we coordinated with State and Federal agencies, and used the public comments generated from the ANPR and NOI to develop a range of actions and mitigation measures that are reflected in numerous alternatives under consideration for the proposed action.

Presentations made at the public scoping meetings, the April 2007 EIS public scoping summary report, a list of the attendees, the ANPR, public comments, and background materials are provided at http://www.fpir.noaa.gov/PRD/prd_spinner_EIS.html.

We relied on the public comments on the ANPR and the NOI, and on new scientific information to develop a range of regulatory and non-regulatory alternatives, including the alternative of not adopting regulations. We analyzed the environmental effects of these alternatives and considered options for mitigating effects. After a preliminary analysis of alternatives, we developed and analyzed the effects of the swim-with and 50-yard (45.7 m) approach regulations, which we chose as our preferred alternative, which includes no interception (i.e., “leapfrogging” or placing a person or vessel in the path of dolphins for the purpose of interception). As more fully discussed below, we specifically seek public comment on whether these proposed measures alone will provide sufficient protection to spinner dolphins from human interactions.

Although not currently proposed, we are considering whether other management measures also may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. Accordingly, we have also analyzed the effects of the alternative management measures of promulgating swim-with and approach regulations, while additionally creating either mandatory (see DEIS Alternative 4) or voluntary (see DEIS Alternative 5) time-area closures in five essential daytime habitats. The results of our analyses are contained in a DEIS. The DEIS is available for review and comment in association with this rulemaking (see ADDRESSES). A description of these alternatives is also included in the Additional Measures Under Consideration section of this proposed rule.

During the initial scoping period for the Spinner Dolphin Human Interaction EIS, we received comments that recommended gathering additional information on Hawaiian spinner dolphins, including monitoring local populations to determine impacts to numbers and overall health of the MHI resident spinner dolphins. In response to this recommendation and to inform this rulemaking effort, NMFS internal grant funding was awarded to the “Spinner Dolphin Acoustics, Population Parameters, and Human Impact Research” (SAPPHIRE) program, conducted jointly by Duke University and Murdoch University. The SAPPHIRE project's objective was to provide baseline data on the local abundance, distribution, and behavior of spinner dolphins in Kealakekua Bay, Honaunau Bay, Kauhako Bay, and Makako Bay off of the island of Hawaii, as well as in nearshore, shallow-water environments near these resting bays. This intensive study integrated a suite of visual and acoustic sampling techniques, using boat-based and land-based surveys, as well as acoustic recording devices, to assess the following: Spinner dolphin daytime habitat use and resting behavior in study areas and surrounding waters; residency and fidelity patterns of spinner dolphins during the day in nearshore habitats in both the study areas and surrounding waters; spinner dolphin exposure to human activities within the studied resting bays and surrounding waters; and spinner dolphin demographic response to human activities within resting bays and surrounding waters.

Research in the four bays and nearshore waters of the island of Hawaii began in August 2010 and was completed in May 2013. Results from this study provided robust population estimates for the Hawaii Island stock (see Background), as well as additional information about spinner dolphin habitat use and the pressure that this resident stock faces from dolphin-directed human activities. Many of these studies have been published in scientific literature and scientific reports and were used to inform this rulemaking process (Thorne et al. 2012, Johnson et al. 2013, Heenehan et al. 2014, Tyne et al. 2014, Tyne 2015, Tyne et al. 2015). Below we describe information gained from several of these studies.

Early researchers (Norris and Dohl 1980, Norris et al. 1994) hypothesized that essential daytime habitats have specific environmental characteristics making them more favorable to the dolphins in supporting resting behaviors, such as shallow, calm, flat, protected, sandy-bottomed bays that provide easy access to nearby deep-water foraging areas. Thorne et al. (2012) used dolphin surveys and predictive habitat modeling to test a suite of these environmental factors that may make spinner dolphins favor these areas. The study found that proximity to deep-water foraging areas, depth, the proportion of bays with shallow depths, and low rugosity (indicating low substrate roughness, i.e., sand) were important predictors of spinner dolphin habitat. The strongest predictors of spinner dolphin resting habitat were distance to the 100-m depth contour (foraging habitat) and depth of the resting areas, with spinner dolphin resting habitat generally occurring in the shallow depths (<50 m) within a bay that was close to the 100-m depth contour and thus, their offshore foraging grounds (Thorne et al. 2012). In tests of these characteristics across the MHI, the bays that were predicted by the model to be optimal resting habitats were consistent with spinner dolphin resting habitats that are recognized as preferred from various observations and identified in the DEIS.

Tyne et al. (2015) further examined key ecological characteristics and spinner dolphin behavior to see which characteristics support resting behavior. The most important factor contributing to the likelihood of rest was the dolphins' presence within a bay, meaning that they were most likely to rest when they were inside a bay (Tyne et al. 2015). Another important factor was the presence of sand substrate. In general, spinner dolphins spent disproportionately more time over sandy substrates in and out of bays; however, outside of bays, spinner dolphins were observed mostly travelling over sandy substrates. This supports the finding that the bays themselves are the most important factor for resting behaviors, because even sandy substrate outside of the bays did not significantly predict resting behavior. This work highlights the role that habitat areas play in supporting important fitness enhancing behaviors, specifically rest.

Johnson et al. (2013) assessed the influence of human activity on the energy budget of Hawaiian spinner dolphins using a theoretical model and comparing predictions from the model to empirical data collected in Kealakekua Bay on spinner dolphin behavior. Under the model, individual dolphins needed to spend at least 60 percent of their time inshore in a resting state to be in a positive energetic balance. Given this assumption, direct observations of spinner dolphins suggest that these animals are currently spending adequate amounts of time engaged in resting behaviors to meet their energetic requirements; however, researchers cautioned that individuals with high energetic demands could be at a deficit. For example, nursing mothers and juveniles generally have a much higher energetic demand and these individuals could be at risk of an energetic deficit. This study also evaluated the likelihood of spinner dolphins resting, given various human activities occurring at different distances. Researchers found that the presence of swimmers within 150 m significantly decreased the likelihood of resting. Interestingly, the likelihood of dolphins resting was higher when vessels were present between 50 and 150 m, creating the appearance of a positive relationship between resting behavior and vessel presence at this distance. These results may demonstrate a difference in dolphins' perceived risk between swimmers and vessels, or a lack of perceived risk associated with vessels. However, this positive relationship between resting behavior and vessels may also be influenced by the high frequency of observations with vessels present between 50-300 m and few observations with no vessels present (Johnson et al. 2013).

Tyne (2015) similarly noted that spinner dolphins off the west coast of the island of Hawaii are exposed to a high rate of human activities and that this rate of exposure may obscure researchers' ability to distinguish disturbance effects associated with intense viewing pressures. In his evaluations, Tyne (2015) found that spinner dolphins were exposed to human activities within 100 m over 80 percent of the time that the dolphins were using essential daytime habitat. Evaluations between control conditions, i.e., no vessels or people within 100 m of dolphins, and exposure conditions, i.e., vessels or people within 100 m of dolphins, suggested that human activities did not have a significant effect on the probability of spinner dolphins engaging in resting, socializing, or traveling. However, control conditions did not occur often (less than 18 percent of the time) or for long periods of time (median duration of 10 minutes), preventing a robust comparison for the purposes of measuring effects. With so little control data and with short durations between exposures to human activity, Tyne (2015) questioned whether the observed data were representative of true or deep resting behavior, or whether observed resting behavior may only be “light” rest. In this case, observing behavior alone may not be a reliable indicator for measuring disturbance effects, because observed resting behavior may not represent behavior that provides restorative benefits for these animals. The rate of exposure to human activities off the west coast of the island of Hawaii is 25 percent higher than reported for other dolphins studied for behavioral response to human activities in other areas of the world (Tyne 2015). This rate of exposure may place resident stocks at risk and long-term disturbance could result in habitat displacement or reduced fitness as seen in other dolphin populations (Bejder et al. 2006a, 2006b; Lusseau and Bejder 2007).

The swim-with and approach prohibitions described in this proposed rule are designed to protect spinner dolphins from take, including harassment and disturbance, caused by dolphin-directed activities that are concentrated in coastal waters (within 2 nm (3.7 km) of shore and in designated waters between Lanai, Maui, and Kahoolawe) and reduce the impact of increased viewing and interaction pressures. Although we stress that unauthorized take of spinner dolphins or any marine mammals already is and continues to be prohibited by the MMPA in any location, we believe that specific regulations aimed at identified human activities that result in take of Hawaiian spinner dolphins is warranted because of the chronic disturbance that is currently taking place in nearshore waters. NMFS is proposing these regulations pursuant to its rulemaking authority under MMPA sections 112(a) (16 U.S.C. 1382(a)) and 102 (16 U.S.C. 1372).

Although not included in this proposed rule, we are also considering whether additional management measures may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. The Additional Measures Under Consideration, Time-Area Closures section below discusses both mandatory and voluntary time-area closures as two alternative management options that may enhance protections for Hawaiian spinner dolphins beyond the proposed swim-with and approach rule.

The proposed rule's swim-with and approach prohibitions would apply to all Hawaiian spinner dolphins found in the action area (see Geographic Action Area section below).

The action area for this rule is limited to waters within 2 nm (3.7 km) of each of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe (see Figures 1 and 2 in section 216.20(e)). The latter designated waters include all water areas enclosed by three line segments that connect points at the 2-nm boundary between the islands as follows: The rhumb line between (A1) 20°32′51″ N./156°43′50″ W. and (A2) 20°42′4″ N./156°55′34″ W. between Kahoolawe and Lanai; the rhumb line between (B1) 20°51′1″ N./156°54′0″ W. and (B2) 20°59′48″ N./156°42′28″ W. between Lanai and Maui; and the rhumb line between (C1) 20°33′55″ N./156°26′43″ W. and (C2) 20°32′15″ N./156°29′51″ W. between Maui and Kahoolawe. Throughout this rule, all coordinates are referenced to the World Geodetic System of 1984 (WGS84).

This is inclusive of the majority of the nearshore habitats where MHI resident stocks of spinner dolphins engage in daytime behaviors and where dolphin-directed human activities that may result in take are known to occur (see Rationale section below).

The regulations apply to all forms of swim-with and approach activities in water and air. Forms of approaching spinner dolphins include, but are not limited to, operating a manned or unmanned motorized, non-motorized, self-propelled, human-powered, or submersible vessel; operating an unmanned aircraft system (UAS) or drone; and swimming at the water surface or underwater (i.e., SCUBA or free diving).

The proposed rule would prohibit people from engaging in the following activities around Hawaiian spinner dolphins:

(1) Approaching or remaining within 50 yards (45.7 m);

(2) Swimming or attempting to swim within 50 yards;

(3) Causing a vessel, person, or object to approach or remain within 50 yards; and

(4) Intercepting, or placing a vessel, person, or other object on a path of a spinner dolphin so that the dolphin approaches within 50 yards of the vessel, person, or object.

NMFS considered specific categories that should be exempt from the regulations, which are proposed below:

(1) Any person who inadvertently comes within 50 yards (45.7 m) of a Hawaiian spinner dolphin or is approached by a spinner dolphin, provided the person makes no effort to engage or pursue the animal and takes immediate steps to move away from the animal;

(2) Any vessel that is underway and is approached by a spinner dolphin, provided the vessel continues normal navigation and makes no effort to engage or pursue the animal;

(3) Any vessel transiting to or from a port, harbor, or in a restricted channel when a 50-yard distance will not allow the vessel to maintain safe navigation;

(4) Vessel operations necessary to avoid an imminent and serious threat to a person or vessel;

(5) Activities authorized through a permit or authorization issued by the NMFS to take spinner dolphins; and

(6) Federal, State, or local government vessels, aircraft, personnel, and assets when necessary in the course of performing official duties.

The exception for vessels transiting to or from ports, harbors, or restricted channels is necessary to allow continuation of safe navigation when approaching spinner dolphins closer than 50 yards is unavoidable. For these cases, the vessel should continue normal navigation to reduce the likelihood that close interactions result in disturbances for an appreciable period of time. The exception for vessel operations necessary to avoid an imminent and serious threat to a person or vessel is needed for the safety of human life and property, and to allow for compliance with applicable navigation rules. The exception for government vessels, aircraft, personnel, and assets operating in the course of official duties is intended to avoid disruption of essential government missions, including enforcement and national security activities. The exception for vessels or persons engaged in an activity authorized through a permit or other authorization issued by the NMFS to take spinner dolphins is necessary to ensure the continued availability of scientific research and biological data necessary to inform management and conservation decisions related to the dolphins. We anticipate that compliance with relevant permit terms and conditions will help minimize the potential impacts to dolphins.

Hawaiian spinner dolphins resident to the MHI are made up of small, genetically isolated stocks that exhibit a specialized behavioral ecology that makes them easy to access in coastal environments during their daytime resting hours. This leaves these resident stocks vulnerable to human-caused disturbance and its effects such as habitat abandonment or declines in reproductive success (Norris et al. 1994, Andrews et al. 2010, Tyne et al. 2014). In the MHI, dolphin-directed activities have increased in recent years and the public's expectation of close interactions has placed increased pressure on resident stocks of Hawaiian spinner dolphins and the habitats that support these stocks (see Background above). Despite outreach, guidelines, and current prohibitions, observations in the field indicate that MHI resident Hawaiian spinner dolphins' natural behaviors are disrupted by activities that include approach by both swimmers and vessels (Ostman-Lind et al. 2004, Danil et al. 2005, Courbis 2004, Courbis and Timmel 2008), and overarching spinner dolphin group behavioral patterns may be changing in essential daytime habitats as a result of these pressures (Norris et al. 1994, Forest 2001, Courbis 2004, Courbis and Timmel 2008).

Observed individual dolphin responses to disturbance events when closely approached by people and vessels include charging or threat displays, aerial displays, and avoidance behaviors such as moving around and away from people and vessels, or leaving the bay in response to human pursuit (Norris et al. 1985, Norris et al. 1994, Forest 2001, Ostman-Lind et al. 2004, Courbis 2004, Courbis and Timmel 2008). Additionally, researchers have observed changes to behavioral patterns in essential daytime habitats, including differences in aerial activity (Courbis and Timmel 2008) and changes in dolphin residence time and distribution within essential daytime habitats, that may be linked to the intensity of human activity (Forest 2001; Danil et al. 2005; Courbis 2004, 2007; Courbis and Timmel 2008; Ostman-Lind 2007).

Chronic disturbance can disrupt natural behavioral patterns associated with feeding, resting, nurturing, and socializing, and diminish the animals' ability to utilize the benefits of important habitat, ultimately resulting in negative impacts to the fitness of individuals and resident populations. For example, disturbance while spinner dolphins are resting detracts from the dolphins' abilities to recuperate from energetically demanding behaviors such as foraging, transiting to and from offshore foraging grounds, and nurturing their young. If these disturbances happen chronically, the lack of consistent, undisturbed resting periods can reduce the amount of energy available to forage and care for young. In other small cetacean populations, chronic human disturbances have been linked to biologically significant impacts such as reduced female reproductive success (Bejder 2005, Lusseau and Bejder 2007).

In other locations globally, intense dolphin-directed human activities have resulted in changes to targeted dolphin populations' habitat use and even caused habitat abandonment (Bejder et al. 2006a, 2006b; Gannier and Petiau 2006; Nature Conservation Sector 2006; Lusseau and Bejder 2007; Notarbartolo-di-Sciara et al. 2009). For example, in a bay in Tahiti, spinner dolphin residence times were negatively influenced by boat presence. Spinner dolphins often left the bays earlier when there was an increase in boat presence, and this increased boat disturbance may have deterred dolphins from entering the bay the next day (Gannier and Petiau 2006). Additionally, in Samadai Reef, Egypt, spinner dolphins were reported as noticeably distressed from excessive numbers of visitors and people attempting to interact with the dolphins (Notarbartolo-di-Sciara et al. 2009). The spinner dolphin group abandoned this preferred resting area, presumably to avoid the disturbance from vessels and visitors (Nature Conservation Sector 2006), and did not returned to the site until after management measures were put in place. Management measures included prohibiting human entry into the core resting area, and restricting certain activities in areas surrounding the core resting area to prevent further disturbance (Nature Conservation Sector 2006, Notarbartolo-di-Sciara et al. 2009).

Chronic disturbance of spinner dolphins in the MHI could negatively affect the habitat use or health of resident populations. Additionally, disturbance effects may be amplified in the MHI's resident stocks, which exhibit high site fidelity and restricted gene flow, because the impacts to multiple individuals' health and fitness are quickly reflected in the overall fitness of these small populations (Bejder 2005).

The 50-yard (45.7 m) approach regulation, including prohibiting swimming with dolphins, is intended to reduce the degree of behavioral disruption from close approaches by vessels and swimmers, while allowing for meaningful dolphin watching opportunities. Research indicates that spinner dolphins exhibit changes and disruptions to natural behaviors from close approach by swimmers (Danil et al. 2005, Courbis and Timmel 2008) and that swimmer presence within 150 m reduces the likelihood of spinner dolphins being in a resting state (Symons 2013, Johnston et al. 2014). Approach by vessels and watercraft have also been shown to disrupt and alter spinner dolphin behavior (Ross 2001, Forest 2001, Timmel et al. 2008). In the MHI, several studies note that close approach by vessels disrupt dolphin behaviors at various distances ranging from 10 m to 300 m (Forest 2001, Timmel et al. 2008). At Midway Atoll in the Northwestern Hawaiian Islands, Ross (2001) found that spinner dolphins were affected by vessel presence at distances as great as 500 m and that the effects increased as the distance decreased. Although Johnson et al.'s (2013) work in the MHI found the likelihood that dolphins were resting was higher when vessels were present between 50 and 150 m, they noted that these results may be influenced by the fact that vessels were present in proximity to the dolphins most of the time.

We have considered multiple distances that may provide protections for spinner dolphins from human activities that result in take (such as swimming with and approaching dolphins), including 50 yards, 100 yards (91.4 m), or even greater distances. NMFS believes that 50 yards is the minimum distance that will prevent most forms of take, while also providing the public with sufficient opportunity to tailor their conduct to avoid disruptive encounters with spinner dolphins. We already recommend this distance (50 yards) in our wildlife viewing guidelines and request that people do not swim-with wild dolphins to reduce the risk of behavioral disruption from close encounters. These guidelines are recognized by tour operators and are used by some (e.g., Dolphin SMART operators) to help ensure that spinner dolphins are viewed responsibly.

A 100-yard approach restriction exists for humpback whales and this distance was also considered for reducing take of spinner dolphins. Spinner dolphins are fast-moving, small cetaceans and groups of dolphins may move through areas changing directions throughout the day. A distance restriction of 100 yards provides more space for these animals to move back and forth, and helps ensure that people and vessels have sufficient opportunity to maintain an appropriate distance to avoid take. A 100-yard approach restriction might also be easier for vessel operators to recognize and achieve, as this distance applies to humpback whales. However, approach regulations at a distance greater than 50 yards may be difficult for recreational swimmers to recognize and achieve in the water. Based on the best scientific information available, it is difficult to determine a precise distance beyond which human activity does not have the potential to cause disturbance by disrupting natural behaviors. However, we recognize that not all approaches within 100 yards result in take, and we are concerned that such a prohibition may unnecessarily burden the public, without necessarily achieving the purposes of this rulemaking. Further, this greater distance may diminish both the experience of dolphin watching and opportunities to participate in dolphin watching, because these animals are small and may be difficult to spot at a distance. NMFS recognizes that the dolphin watching industry is important to Hawaii's economy, and that these tours have the ability to inform the public about dolphins and to foster stewardship. To reduce the threat of take occurring (including harassment and disturbance) when swimmers and vessels closely approach dolphins, to remain consistent with the current recommended approach guideline for the region, and to allow for continued dolphin watching opportunities at safe distances, NMFS is proposing a distance of 50 yards for swim-with and approach restrictions.

The proposed swim-with and approach regulations prevent a range of human activities that occur in close proximity to Hawaiian spinner dolphins. This includes swimming-with spinner dolphins, touching or attempting to touch spinner dolphins; corralling or herding spinner dolphins into small areas; and leap-frogging, all of which have the potential to disturb the dolphins and result in take. Implementation of these prohibitions would include enforcement by NMFS and DLNR Division of Conservation and Resource Enforcement (DOCARE) personnel, and outreach by NMFS staff and volunteers who would assist with an informational campaign about the new regulation and the scientific information on which it is based. This proposed rule provides new tools for enforcement that are measurable, easy to understand, and based on the best available science regarding human impacts on spinner dolphins. To limit some potential impacts to the public from these regulations, we propose exceptions that are designed to allow for transit into and out of ports, harbors, and restricted channels; public safety measures; avoidance of penalties when the animal has closely approached a boat or person; and continuation of essential government and permitted activities (see Exceptions section above). The DEIS contains a full analysis of a No Action Alternative, other alternatives, and the Preferred Alternative.

The costs of implementing human and vessel regulations to protect the dolphins are expected to be low. Some will be borne by the commercial dolphin watch and dolphin swim industry, dolphin-associated spiritual retreats, and other generalized nature tours (see the DEIS and the Regulatory Flexibility Act section below for more information). While some dolphin watch companies and community members have suggested that restricting swimming with the dolphins or closely approaching them may affect revenue, surveys of tour participants indicate that close approach of the dolphins may not be the most important aspect for the dolphin watching participants, and that participants will support viewing these animals in a manner that reduces the potential for disruptive encounters with dolphins (Wiener 2015). Other impacts to boaters, swimmers, kayakers, and others who are not engaged in dolphin-directed activities are expected to be minor and include slight changes to operations to comply with the proposed regulations.

The reduction in disturbance to Hawaiian spinner dolphins, as addressed through each element of the rule as described above, provides a benefit to the dolphins as well as to members of the public who value the dolphins. Reducing threats to the dolphins also supports the long-term sustainability of the responsible dolphin watching industry.

The proposed regulations are designed to address dolphin-directed activities that are resulting in various forms of take of Hawaiian spinner dolphins. NMFS selected 2 nm (3.7 km) from shore around the MHI as well as designated waters between the islands of Lanai, Maui, and Kahoolawe as the boundary for the proposed prohibitions because this range encompasses the areas where current and best available information indicates that most dolphin-directed activities are likely to be concentrated. NMFS gathered information from scientific literature about Hawaiian spinner dolphin daytime habitat preferences and information from over 400 sightings of spinner dolphins collected around the MHI since 1992 from various members of the Pacific Islands Photo Identification Network (PIPIN) to determine where resident spinner dolphins are likely to occur during the day. Dolphin-directed activities in Hawaii are concentrated in the nearshore portion of the island-associated Hawaiian spinner dolphin stocks' ranges because these stocks are easily accessed in coastal waters during the day when most people seek out marine recreational activities.

Daytime habitat for Hawaiian spinner dolphins varies across the MHI, because the bathymetry, or depths and shapes of underwater terrain, is different for each island, and spinner dolphins seek out areas with physical and biological characteristics that support their ecological needs (see Background section). On Hawaii Island, Norris et al. (1994) indicate that spinner dolphins generally prefer areas with depths of less than 50 m for engaging in resting activities, and Thorne et al. (2013) note that resting habitats generally occur in close proximity to the 100-m contour (close to the inshore extent of prey species at night). Spinner dolphins are also known to transit along Hawaii Island's coastline, moving between resting areas during the day. Lammers et al. (2004) indicate that Oahu's spinner dolphins show a strong affinity for the 10-fathom isobath (18.3 m), and note that approximately 93 percent of sightings off Waianae and 81 percent of sightings off the south shore of Oahu occurred at depths shallower than 17 fathoms (31.1 m). Lammers et al. (2004) also note that foraging activities begin by evening around the 100-fathom isobath (182.9 m) off Oahu. Information received from PIPIN indicates that approximately 89 percent of spinner sightings across the MHI were in waters within the 100-m depth contour and that 95 percent were in waters within the 200-m depth contour, although spinner dolphins have been observed in waters during the day where depths are as great as 3,000 m (NMFS 2016).

In reviewing this information, we determined that selecting a boundary based on depth in any particular area may be difficult for people to identify without having access to proper instrumentation (which would be especially difficult for kayakers, standup paddleboarders, and swimmers), and that the distance from shore may provide a more easily discerned boundary. In addition, although spinner dolphin daytime habitat may be located at different distances from the shoreline of different islands, establishing different prohibitions based on the location of these daytime habitats (e.g., having restrictions out to 1 nm (1.9 km) or 2 nm depending on the island) could subject the public to inconsistent and confusing requirements, and complicate both enforcement of and compliance with these regulations. This could be particularly difficult in areas where multiple islands are visible and the restricted distances differ around different islands. Therefore, we evaluated consistent distances from shore across the MHI.

We reviewed the habitat preferences and sighting information as it relates to distance from shore to identify a boundary that would be easy for people to recognize and would incorporate the best available information about spinner dolphin habitat preferences and sighting information. Along the west coast of Hawaii Island, habitats that are 50 m or less in depth and where dolphin-directed activities are prevalent, are encompassed within 1-1.5 nm (1.9-2.8 km) from shore. Habitats within 100 m depth fall almost entirely within 2 nm of shore, and at 3 nm (5.6 km) these areas are entirely included. Off the west coast of Oahu, where most dolphin-directed activities on this island occur, the 10-fathom (18.3 m) isobath is largely captured within 1 nm of shore, while 17 fathoms (31.1 m) is largely captured within 1.5 nm. Habitats of these depths extend out farther on the south shore where spinner dolphins are also known to rest; these habitats are largely captured within 1.5 and 2 nm from shore respectively. The 100-fathom (182.9 m) contour is largely captured within 1.5 nm on the west side of the island, but extends out past 3 nm on the south shore. Little information is available from the other MHIs regarding specific depth preferences, although there are areas where the 50- and 100-m depth contours extend past 4 nm (7.4 km). Off most of the MHI, a large majority of the PIPIN sighting information is captured within 2 nm from shore.

A key area for spinner dolphin sightings during the day, where the depth contour extends out past 4 nm, is between the islands of Lanai, Maui, and Kahoolawe. This area is traversed by many recreational and commercial tour vessels in search of marine mammal viewing opportunities throughout the day. Consequently, spinner dolphins also require protections in this area. To ensure that dolphins are protected throughout the day where they may transit between islands and encounter dolphin-directed activities, we delineated an area around all three islands that includes the 2-nm buffer around the outside of each island and the channels and waters between these islands. This delineated area includes 96 percent of all PIPIN sighting information across the MHI.

We are proposing this action to reduce the threat of take of Hawaiian spinner dolphins (including harassment and disturbance) caused by dolphin-directed activities that are concentrated in coastal waters of the MHI and to reduce the impact of increased viewing and interactions pressures on MHI resident stocks. We do not expect that these same pressures are prevalent in the outer portions of the MHI stocks' ranges, because these spinner dolphins are not easily accessed when they are offshore. Therefore, the proposed rule applies to an area within 2 nm of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe. This area encompasses the majority of the resident stocks' daytime habitat, thereby incorporating the area where spinner dolphins are easily accessed and where take of Hawaiian spinner dolphins is most likely to occur.

Although not currently proposed, we are also considering and seeking public comment on whether additional management measures (beyond swim-with and approach regulations) may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. At this time, we believe that the swim-with and approach regulations alone will provide sufficient protection to Hawaiian spinner dolphins, by reducing close encounters between spinner dolphins and humans that result in take. We also expect that the swim-with and approach regulations will reduce the intensity of activities within essential daytime habitats that are targeted by people for dolphin-directed activities to some degree. However, NMFS recognizes that the intensity of activity in some of these areas is high and that additional measures could be necessary.

Area closures have been shown to be an effective management tool for addressing the intensity of wildlife viewing and interaction in other areas globally (Notarbartolo-di-Sciara et al. 2009, Nature Conservation Sector 2006). Area closures provide members of the public with precise boundaries so that they may readily tailor their conduct accordingly. However, area closures can also carry undesired costs, such as by imposing a burden on the public when spinner dolphins are not present. We are mindful of this potential and believe a careful approach is warranted. By first implementing swim-with and approach regulations, we expect to reduce take of Hawaiian spinner dolphins resulting from interactions with swimmers and vessels. We also expect to gather additional information about the effectiveness of these measures. Should this action's swim-with and approach regulations provide insufficient protection for Hawaiian spinner dolphins using essential daytime habitats, we would consider additional conservation and management measures, including time-area closures, to reduce take in high intensity areas. Below we discuss two management options that are analyzed in the DEIS. We invite public comment about whether and at what point these management options or others may be necessary and appropriate to protect Hawaiian spinner dolphins from take.

Two possible management options evaluated in the DEIS would create either mandatory (see Alternative 4 in the DEIS) or voluntary (see Alternative 5 in the DEIS) time-area closures in five essential daytime habitats, in addition to the swim-with and approach regulations. We selected the five areas for potential time-area closures using a step-down process. In this approach, we identified important habitats that might benefit from additional protection, and then considered additional factors that may promote or obstruct the effectiveness of the closure. (See Appendix A of the DEIS for more detail.) The five sites are essential daytime habitats where human activities are largely Hawaiian spinner dolphin-directed, where closures are logistically feasible, and where regulatory measures can be balanced most effectively with human ocean use to protect these dolphins. Once the sites were selected for time-area closures, we delineated core areas within each of the five sites where spinner dolphins are most often engaged in resting activities. The core areas would be subject to closure, while leaving other areas of the bays open in order to minimize impacts on other human activities (e.g., snorkeling, surfing).

As noted in the SAPPHIRE Project section above, essential daytime habitats are particularly important to island-associated spinner dolphins because the habitats provide environmental characteristics that support the dolphins' ability to minimize travel to offshore food sources and to detect predators (Norris and Dohl 1980, Norris et al. 1994, Thorne et al. 2012). Tyne et al. (2014) reported that spinner dolphins off the island of Hawaii are most likely to rest while inside these habitats that support predator detection and noted that dolphins using these areas off the west coast of Hawaii are experiencing human activities within 100 m over 80 percent of the time. Chronic wildlife disturbance within important habitats may lead to habitat abandonment and/or negatively impact the health of individual dolphins, ultimately leading to population level impacts (Frid and Dill 2002, Bejder 2006). Additional management in these areas may be important to ensure that Hawaiian spinner dolphins are given sufficient space for groups to engage in deep resting behaviors that allow dolphins to recuperate from other energy demanding activities, such as foraging.

For time-area closures we are considering a closure time of 6 a.m. to 3 p.m. This time-period would allow spinner dolphins to enter essential daytime habitats without disturbance and remain in these areas undisturbed during peak resting hours, while allowing for human activities to occur (at a distance greater than 50 yards (45.7 m) in accordance with the approach regulations) after 3 p.m. Historic spinner dolphin resting times (before human interactions were likely a major factor in the dolphins' resting patterns) were observed to occur between dawn and dusk (Norris and Dohl 1980), and research indicates that Hawaiian spinner dolphin resting behavior still occurs throughout daytime hours (generally 6 a.m. to 6 p.m.) with the highest resting activity occurring between 10 a.m. and 2 p.m. (Tyne et al. 2015). Nevertheless, some Hawaiian spinner dolphin groups have been deterred from entering their essential daytime habitat if human presence in the area was too high early in the day (Danil et al. 2005). Preventing disturbance in these habitats during early morning hours is important to support spinner dolphins' arrival to the essential daytime habitat and their descent into rest. The late afternoon hours are considered a time of transition and described as a time when the dolphins rally together and engage in zig zag movements as they are waking from their deep rest, prior to moving offshore to their foraging grounds (Norris et al. 1994). However, the afternoon hours are also a popular time for human recreational use. Because the swim-with and approach regulations would provide a measure of protection for spinner dolphins as they increase activity toward the end of their resting period, we would end the closure time at 3 p.m. Swim-with and approach regulations would continue to provide a buffer of protection to the dolphins at the end of their peak resting times, while also allowing some of these human activities to occur for a limited time period.

For either mandatory or voluntary closure options, the closure areas would be marked using buoys, sight-line markers, and landmarks from shore, and explanations of the closure's purpose and effective hours would be provided by signs on land and through other public outreach efforts. The intent of both mandatory and voluntary closures would be to prevent take by eliminating the intense human activity within essential daytime habitats during important resting times. These closures would allow for increased opportunities for spinner dolphins to engage in fitness-enhancing behaviors in the absence of vessels and people.

The bays identified for the mandatory and voluntary time-area closure options are (1) Makako Bay, (2) Kealakekua Bay, (3) Honaunau Bay, and (4) Kauhako Bay on the island of Hawaii, and (5) La Perouse Bay on the island of Maui. Below we describe the areas delineated for the time-area closures; these areas are also depicted in Figures 1-5 of this preamble.

Makako Bay. The lines between points A, B, C, and D shown in Figure 1 illustrate the marine boundaries for the time-area closure for Makako Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and D. The following geographic coordinates provide the approximate location for each point in Figure 1: A) 19°44′21.61″ N., 156°3′16.37″ W.; B) 19°44′25.18″ N., 156°3′26.07″ W.; C) 19°44′2.16″ N., 156°3′35.51″ W.; and D) 19°43′57.31″ N., 156°3′23.04″ W. Two buoy markers would be placed at points B and C aligned with site line markers on shore at points A and D to delineate the closure area (Figure 1). The closure encompasses approximately 0.14 mi2 (0.36 km2) of essential daytime habitat used by Hawaiian spinner dolphins. These coordinates, and coordinates for the other time-area closures, are considered approximate because the exact locations would not be specified until the buoy anchoring system is identified and an underwater survey is completed.

No public access point from shore is identified by the County of Hawaii for Makako Bay. The closest access points are identified south at Wawaloli Beach, with another access point identified North at Keahole Point.

Kealakekua Bay. The lines between points A, B, C, and D shown in Figure 2 illustrate the time-area closure for Kealakekua Bay. The following geographic coordinates provide the approximate location for each point in Figure 2: A) 19°28′37.82″ N., 155°55′15.03″ W.; B) 19°28′54.23″ N., 155°55′44.90″ W.; C) 19°28′48.42″ N., 155°55′49.04″ W.; and D) 19°28′32.19″ N., 155°55′19.20″ W. The closure area would be delineated by means of six marker buoys—one located at each corner and one located at the middle of each of the lengthwise boundaries. Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.08 mi2 (0.21 km2) of essential daytime habitat used by Hawaiian spinner dolphins.

The County of Hawaii identifies two public access points on Boulder Beach and Napoopoo Landing at Kealakekua Bay; both points would remain open for access. Additionally, the route used by kayakers to access the Captain Cook Monument at Kaawaloa from Napoopoo Pier is located outside of the closure area. A line on the map going across the bay depicts this route.

Honaunau Bay. The lines between points A, B, and C shown in Figure 3 illustrate the marine boundaries for the time-area closure for Honaunau Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and C. The following geographic coordinates provide the approximate location for each point in Figure 3: (A) 19°25′27.13″ N., 155°54′41.65″ W.; (B) 19°25′21.41″ N., 155°54′58.17″ W.; and (C) 19°25′31.99″ N., 155°54′58.24″ W. The closure site at Honaunau would be delineated by means of a single marker buoy at point B to accommodate local native Hawaiians' requests to honor the sacred nature of this cultural site, and would be aligned with site line markers on shore at points A and C (Figure 3). Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.04 mi2 (0.10 km2) of essential daytime habitat used by Hawaiian spinner dolphins.

The County of Hawaii identifies Honaunau Bay boat ramp as a public access area for this bay. The boat ramp and the popular access point for swimming and snorkeling known as Two-Step are located outside of the closure area, and would remain open for everyday use.

Kauhako Bay. The lines between points A, B, and C shown in Figure 4 illustrate the marine boundaries for the time-area closure for Kauhako Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and B. The following geographic coordinates provide the approximate location for each point in Figure 4: (A) 19°37′86.15″ N., 155°89′68.10″ W.; (B) 19°37′91.79″ N., 155°89′95.98″ W.; and (C) 19°37′04.02″ N., 155°89′70.41″ W. A single marker buoy would be placed approximately 35 m from shore to delineate the inner bay closure boundary. Sight line markers at each of the points A, B and C (Figure 4), and two buoys placed along the offshore boundary (line B-C) would delineate the closure area at this bay. Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.087 mi2 (0.18 km2) of essential daytime habitat used by Hawaiian spinner dolphins.

The County of Hawaii identifies Hookena Beach Park as a public access point for this area. The nearshore area located inshore of the line between points A and B would be open for everyday use, including swimming, snorkeling, and freediving.

La Perouse Bay. The lines between points A, B, C and D shown in Figure 5 illustrate the marine boundaries for the time-area closure for La Perouse Bay; the shoreline boundary is at the mean lower low water line (meaning activities could occur in the intertidal zone) between points A and C, and between B and D. The following geographic coordinates provide the approximate location for each point in Figure 5: (A) 20°35′56.90″ N., 156°25′17.04″ W.; (B) 20°35′25.68″ N., 156°24′44.72″ W.; (C) 20°35′39.30″ N., 156°25′33.85″ W.; and (D) 20°35′10.98″ N., 156°24′50.90″ W. A single marker buoy would be placed approximately 100 m offshore of the most popular snorkeling entry point to delineate the nearshore boundary line, with three buoys placed along the offshore boundary line (line C-D) to delineate the outer closure boundary. Shore-based markers at points A, B, C, and D would provide a sightline. Informational signs would be placed on shore to inform the public of the closure areas. The closure encompasses approximately 0.32 mi2 (0.83 km2) of resting habitat used by Hawaiian spinner dolphins.

Maui County identifies La Perouse as a public access point for this area (coordinates: 20°36′09.66″ N., 156°25′22.48″ W.). The area inshore of the line between A and B, which includes this access point, would remain open for everyday uses such as surfing, snorkeling, and freediving.

Activities occurring in the intertidal zone (the area that is above water at low tide and under water at high tide), such as shore-based fishing and subsistence gathering, would be able to continue during any time of day in either type of closure.

Although not currently proposed, if we were to implement mandatory time-area closures in addition to promulgating swim-with and approach regulations (described under Alternative 4 in the DEIS), we would create the time-area closures (depicted in Figures 1-5 above) and promulgate regulations that prohibit use of waters within the five delineated areas from 6 a.m. to 3 p.m.. All Exceptions (see section above) described for the proposed swim-with and approach regulations would apply to this alternative, and the following three additional exceptions would also apply to the mandatory time-area closures:

(1) Vessels that transit the time-area closure for the sole purpose of ingress and egress to privately-owned shoreline residential property located immediately adjacent to the time-area closure;

(2) Vessels participating in organized community-based outrigger canoe races that transit straight through a time-area closure; and

(3) Vessels that transit straight through the time-area closure for the purpose of traditional subsistence fishing where harvested resources are intended for personal, family, or community consumption or traditional use and not for commercial market sale.

Entering mandatory time-area closures during closed periods would result in a violation unless an exception to the rule applies.

Mandatory time-area closures would prevent take within these important areas and ensure that spinner dolphins are provided space to achieve deep rest during the day. Additionally, regulations to impose these closures would provide a strong tool for enforcement that is measurable and easy to understand, promoting both enforcement and compliance. Under this management option, swim-with and approach regulations would reduce disturbance to Hawaiian spinner dolphins from close approach activities throughout nearshore areas, and mandatory time-area closures would provide additional protection by reducing the intensity of viewing pressure in five essential daytime habitats.

Although not currently proposed, if we were to implement voluntary time-area closures in addition to promulgating swim-with and approach regulations (Alternative 5 in the DEIS), we would demarcate the same five areas for voluntary time-area closures as are described for the mandatory closures (see Mandatory Time-Area Closures with Swim-with and Approach Regulation above). Through outreach, we would ask the public to refrain from using waters within the five delineated areas from 6 a.m. to 3 p.m. Participation in the time-area closures would be voluntary, and no penalties would apply to people or vessels that enter the areas during designated spinner dolphin resting times. The voluntary time-area closures would not apply to any activity that falls within the Exceptions (see above) described for the swim-with and approach regulations, or the three additional exceptions described for the mandatory time-area closures option (see three exceptions in the Mandatory Time-Area Closures and Swim-with and Approach Regulations section above). Under this alternative, compliance with the time-area closure would be voluntary.

Success with voluntary measures requires strong community engagement and support. Ideally, conservation benefits for Hawaiian spinner dolphins would be the same for mandatory and voluntary closures because both management measures demarcate space for Hawaiian spinner dolphins to engage in resting behaviors. However, we expect that compliance with voluntary measures would be generally lower than compliance with regulations that are enforced (May 2005), and within the five bays, resource users are diverse and have varying motivations and beliefs with regard to Hawaiian spinner dolphin conservation. The lack of a common understanding about the value of these conservation measures may make it difficult to achieve voluntary compliance for the closures. Further, inconsistent compliance with voluntary measures could lead to increased tension between resource user groups that have conflicting views about Hawaiian spinner dolphin conservation.

NMFS did not propose some of the regulatory options suggested in the ANPR and in public comments for several reasons, including the measures' inability to meet the purpose and need for this rulemaking (see the DEIS for more detail), difficulties in enforcing them, changes to infrastructure needed to implement them, lack of effectiveness of the measures, lack of resources available to institute them, and the complexity associated with complying with the measures. For example, a permit certification program for all marine operators that engage in some form of dolphin viewing would be inappropriate for addressing chronic and concentrated viewing practices, would require a large processing infrastructure to implement throughout the Hawaiian Islands, and would not address disturbance caused by vessels that are not conducting dolphin tours (e.g., recreational vessels or kayaks). Another suggestion, implementing full closures of all identified resting habitats throughout the Hawaiian Islands, would create many restrictions on activities that are not dolphin-directed, obstruct some harbors, be costly, and require a larger infrastructure to institute and enforce. We discuss these and other regulatory options suggested in public comments in the DEIS for this action.

We are soliciting comments on any aspect of these proposed swim-with and 50-yard (45.7 m) approach regulations. As explained above, NMFS does not propose to implement mandatory or voluntary time-area closures as part of this rulemaking. At this time, NMFS believes that the proposed swim-with and approach regulations will provide adequate protection to spinner dolphins against take, including harassment and disturbances. Should NMFS determine that swim-with and approach regulations provide insufficient protection for Hawaiian spinner dolphins using essential daytime habitats, we would consider additional conservation and management measures, including time-area closures to reduce take in high intensity areas, in a separate rulemaking.

We are particularly interested in comments concerning the following: (1) Effects of the increasing number of human interactions with Hawaiian spinner dolphins; (2) proposed prohibited and exempted activities; (3) whether 50 yards is the most appropriate distance for swim-with and approach restrictions to reduce take of spinner dolphins; (4) whether 100 yards (91.4 m) or another distance is the most appropriate distance for swim-with and approach restrictions to reduce take of spinner dolphins; (5) research recommendations and priorities for better understanding how human disturbance affects Hawaiian spinner dolphins; (6) information on responsible viewing of marine mammals; (7) additional information on spinner dolphin behaviors; (8) other human activities affected by the proposed rule that were not discussed; (9) the temporal and geographic scope (i.e., 2 nm from shore) of the approach regulation; (10) whether the area where the approach regulation is proposed in the Lanai- Maui-Kahoolawe triangle is adequate and appropriate; (11) whether time-area closures are necessary to address the intensity of Hawaiian spinner dolphin-directed activities in some areas; (12) the effectiveness of mandatory versus voluntary closures; (13) the bays and times of day identified for time-area closures; (14) information about other areas where Hawaiian spinner dolphins may face pressures from human viewing and interaction; and (5) suggestions on other areas that should be considered for time-area closures.

Please be aware that all comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

A complete list of all references cited in this proposed rule can be found on our Web site at: http://www.fpir.noaa.gov/PRD/prd_spinner_EIS.html, or at www.regulations.gov, and is available upon request from the NMFS office in Honolulu, Hawaii (see ADDRESSES).

NMFS has prepared a DEIS and an RIR pursuant to NEPA (42 U.S.C. 4321 et seq.) and Executive Order (E.O.) 12866, to support this proposed rule. The DEIS/RIR contains a full analysis of a No Action Alternative, five action alternatives, and the Preferred Alternative that we are proposing. There are a number of elements that were common to all of the action alternatives analyzed, including the preferred alternative proposed in this notice, and a number of exceptions that would apply to these alternatives. The DEIS/RIR and supporting documents are available for review and comment and can be found on the NMFS Pacific Islands Region Web site at http://www.fpir.noaa.gov/PRD/prd_spinner_EIS.html.

Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, whenever an agency publishes a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a Regulatory Flexibility Analysis describing the effects of the rule on small entities, i.e., small businesses, small organizations, and small government jurisdictions.

Pursuant to the RFA, NMFS prepared the following Initial Regulatory Flexibility Analysis (IRFA). A description of the action, why it is being considered, and the legal basis for this action are contained in the preamble to this proposed rule. This proposed rule does not duplicate, overlap, or conflict with other Federal rules. The analysis contains a description of and, where feasible, an estimate of the number of, small entities to which the proposed rule will apply. The Small Business Administration (SBA) establishes criteria for defining a “small entity” for purposes of the RFA. This IRFA analyzes the proposed alternatives and other alternatives described in the preamble to the rule, and does not address alternatives previously considered and subsequently dismissed in the DEIS. There are no record-keeping or reporting requirements associated with this proposed rule.

There are several types of industries directly affected by this proposed rulemaking: Swim-with-wild-dolphins tour operators; dolphin watch tour operators; non-motorized vessel ocean wildlife viewing tour operators; and generalized commercial boat tour operators. This analysis uses size standards prescribed by the SBA. Specifically, for scenic and sightseeing water transportation operators (North American Industry Classification System Code 487210), the SBA size standard for a small business is average annual receipts of $7.5 million or less. Much of the background information for potentially affected entities is based on a 2007 report that summarized surveys and other information collected in 2006 with regard to participants within these industries that potentially interact with Hawaiian spinner dolphins to varying degrees in the MHI (Impact Assessment 2007). The report provides information that suggests that all businesses operating in the swim-with-wild-dolphins tour and the kayak tour industries operating in 2006 could be considered small entities, and all but one of the generalized commercial boat tour operators were assumed to be small entities (Impact Assessment 2007). This is the most recent information available to NMFS regarding revenue information, but NMFS notes that the composition of these vessel-based tour industries, including the number which can be considered small entities and the total number, may have changed since the report was written.

Swim-with-wild-dolphins tour operators are those that bring clientele into close proximity with spinner dolphins. This includes health and/or spiritual retreat operations as well as dolphin-oriented swim tours. Health and spiritually-linked businesses provide opportunities for persons wishing to interact with spinner dolphins for perceived physical, mental, and/or spiritual well-being enhancement. Spiritually-linked tour operations may charter vessels through other established dolphin-swim companies to transport customers as part of an overall per-person package consisting of lodging, swimming with dolphins, and other activities. For spiritual retreats that offer dolphin swims, the number of businesses is estimated to be as follows: Hawaii (22), Maui (7), Oahu (1), and Kauai (2+).

Dolphin-oriented swim tours operate by transporting passengers by boat or having them swim from shore to areas in which dolphins are known to be present during daytime hours. Customers may also be provided with facemasks, fins, floatation devices, and snorkels to enhance viewing. Recent information compiled by NMFS suggests that the number of swim-with-dolphins tour companies is as follows: Hawaii (22), Maui (2), Oahu (10), and Kauai (1). All are believed to be small entities.

Dolphin-watch tour operators involve taking clients out specifically to view wild dolphins. These companies tend to operate smaller boats than the more generalized commercial boat tours described below, and are more likely to view dolphins at a closer range. Revenue information for this specific business category is not available. NMFS estimates the number of dolphin watch tour businesses to be as follows: Hawaii (3), Maui (21), Oahu (3), and Kauai (11).

More generalized commercial boat tours offer a range of ocean activities, which may include sightseeing, snorkeling, diving, viewing various forms of sea life from a vantage point in and/or above the water, or just generally spending time on the ocean. The majority of the general tour boats derive revenue from whale watching and sightseeing operations, while a number of the dive/snorkel vessels offer snorkeling or diving trips. Based on recent information collected by NMFS, the estimated number of generalized commercial boat tour businesses reportedly involving indirect dolphin interaction is estimated as follows: Hawaii (10), Maui (19), Oahu (36), and Kauai (12). NMFS believes that most, but not all, would be considered small entities.

Non-motorized vessel ocean wildlife viewing tour operators, specifically kayak tour businesses around the MHI, provide a general wildlife viewing experience, with a very small number of operators advertising direct or intentional interactions with dolphins. The number of kayak tour operators who advertise the opportunity to directly interact with wild dolphins is not available. NMFS estimates the numbers of companies that either operate kayak tours or rent out kayaks to be as follows: Hawaii (6), Maui (9), Oahu (6), and Kauai (13).

The estimated numbers of small entities directly affected by the proposed rulemaking, by industry, on the MHI are as follows: 67 swim-with-wild-dolphins tour operators (including health and/or spiritual retreats enabling opportunities to swim with wild dolphins), 77 generalized commercial boat tour operators (one or more of which are likely to be considered large entities), and 34 kayak tour and rental companies.

The preferred alternative would restrict all activities associated with close approach to Hawaiian spinner dolphins, including swimming with dolphins and close approach by vessel. These prohibitions would be applicable within 2 nm (3.7 km) of each of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe.

The proposed action to ban swimming and approaching within 50 yards (45.7 m) of Hawaiian spinner dolphins, has the potential to eliminate all commercial activities that result in take of spinner dolphins (e.g., swim-with-wild-dolphins) at a close distance. Therefore, implementing this proposed action would require operators that currently offer the opportunity to swim with spinner dolphins to cease this specific activity, although they may choose to continue to provide other services among their menu of options. For example, a spiritual retreat that offers a menu of other activities along with swim-with-wild-dolphins activities may continue to offer the other activities. In addition, swim-with-wild-dolphins tour operators may choose to transition to operate as a dolphin-watching or generalized tour vessel operation. For these businesses, eliminating opportunities to swim with wild spinner dolphins within 50 yards is likely to result in a reduction in revenue in the short term and potentially in the long term. The decrease in revenue could come from the reduction in the number of customers, specifically those who seek the experience of swimming with spinner dolphins, and/or reduced trip or package prices with a reduced menu of options available for each trip. The loss in overall revenue to individual businesses and the industry as a whole that rely on close approach with spinner dolphins by any means for revenue is uncertain. The same is true with regard to the number of businesses that would be still be able to remain in operation if the proposed regulation is implemented.

Commercial wildlife boat tour operators, including generalized commercial boat tour operators, dolphin watch tour operators, and non-motorized vessel tour operators, would no longer be able to take customers to view Hawaiian spinner dolphins from closer than 50 yards. Restricting operators from approaching within 50 yards of spinner dolphins may reduce demand for vessel-based tours among customers who specifically hope to view dolphins from a vessel at a closer range, although there will be no options other than not taking a tour at all, as no boats in Hawaii would be able to offer tours closer than 50 yards. Some tour operators may be able to offer alternative recreational opportunities or amenities as part of a tour to help offset any loss in demand for tours. For generalized tour boat operators with a clientele base that does not have a specific goal of viewing spinner dolphins, the direct economic impact of the proposed action is likely to be minimal.

NMFS concludes that there would be disproportionate impacts to the swim-with-wild-dolphin tour operators from implementation of this preferred alternative relative to all other general wildlife viewing tour operators. Similarly, because of the focus of activities, it is also likely that the dolphin watch tour industry will face greater impacts than the generalized wildlife tour companies. As a result, dolphin-watch tour entities may face disproportionate impacts relative to the generalized commercial boat tour companies, which are likely to incur few direct economic impacts from the proposed action. We note that dolphin watch tour entities are all believed to be small entities, and most of the generalized commercial boat tour companies are as well, although a few might be considered large entities with revenues exceeding $7.5 million.

NMFS considered other alternatives in addition to the swim-with and 50-yard approach regulations in this proposed rule (i.e., Alternative 3a). These include 1) no action; 2) swim-with regulations; 3b) swim-with and 100-yard (91.4 m) approach regulations; 4) mandatory time-area closures and swim-with and approach regulations; and 5) voluntary time-area closures and swim-with and approach regulations. As is the case for this proposed action, Alternatives 2, 3b, 4, and 5 would all be applicable within 2 nm of each MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe. Among the non-selected action alternatives, only Alternative 2 (no swimming with Hawaiian spinner dolphins) would result in a lower direct economic impact to small entities. While the restriction on swimming with dolphins would address one threat to Hawaiian spinner dolphin population, this alternative would not address the remaining documented threats to dolphin populations caused by close approach by vessels and other craft. Section 4.2.2 of the DEIS provides more detail. The remaining non-selected action alternatives would most likely result in a higher economic impact to individual small entities and the dolphin-viewing industry as a whole, relative to the preferred alternative of this proposed action. NMFS has determined that the proposed action meets the goals and objective of reducing human-caused disturbances that Hawaiian spinner dolphins are facing in their natural habitat, and helps protect against declines in the fitness of the population over time.

No additional reporting, record keeping, and other compliance requirements are anticipated for small businesses. NMFS has identified no Federal rules that may duplicate, overlap, or conflict with the action alternatives.

This proposed rule was determined to be not significant for purposes of E.O. 12866.

The purpose of the Paperwork Reduction Act is to minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, and other persons resulting from the collection of information by or for the Federal government. The preferred alternative includes no new collection of information, so further analysis is not required.

The goal of the National Historical Preservation Act (NHPA; 16 U.S.C. 470 et seq.) is to have Federal agencies act as responsible stewards of our nation's resources when their actions affect historic properties. Section 106 of the NHPA requires Federal agencies to take into account the effects of undertakings they carry out, assist, fund, or permit on historic properties. Federal agencies meet this requirement by completing the section 106 process set forth in the implementing regulations, “Protection of Historic Properties,” 36 CFR part 800. The goal of the section 106 process is to identify and consider historic properties (or sites eligible for listing) that might be affected by an undertaking, and to attempt to resolve any adverse effects through consultation. The process provides for participation by State Historic Preservation Officers, Tribal Historic Preservation Officers, tribal, state and local governments, Indian tribes and Native Hawaiian organizations, applicants for Federal assistance, permits, or licenses, representatives from interested organizations, private citizens, and other members of the public. Federal agencies and consulting parties strive to reach agreement on measures to avoid, minimize, and mitigate adverse effects on historic properties and to find a balance between project goals and preservation objectives.

Under the NHPA, an “effect” means an alteration to the characteristics of a historic property qualifying it for inclusion or eligibility for the National Register. The proposed swim-with and approach regulations for Hawaiian spinner dolphins, if finalized, would not have the potential to cause effects on or alterations to the characteristics of historic properties. Therefore, section 106 consultation is not required.

Section 307(c)(1) of the Federal Coastal Zone Management Act of 1972 requires that all Federal activities that affect any land or water use or natural resource of the coastal zone be consistent with approved state coastal zone management programs to the maximum extent practicable. We have determined that these proposed swim-with and approach regulations are consistent to the maximum extent practicable with the enforceable policies of the approved Coastal Zone Management Program of Hawaii. This determination, a copy of this document, and the DEIS will be submitted for review by the Hawaii Coastal Zone Management Program.

E.O. 13132 requires agencies to take into account any federalism impacts of regulations under development. It includes specific consultation directives for situations in which a regulation may preempt state law or impose substantial direct compliance costs on state and local governments (unless required by statute). NMFS has determined that the proposed swim-with and approach regulations do not have federalism implications.

Pursuant to Section 515 of Public Law 106-554 (the Information Quality Act), this information product has undergone a pre-dissemination review by NMFS. The signed Pre-dissemination Review and Documentation Form is on file with the NMFS Pacific Islands Regional Office (see FOR FURTHER INFORMATION CONTACT).

For the reasons set out in the preamble, 50 CFR part 216 is proposed to be amended as follows: